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NCT02922101 | ALL | ADULT, OLDER_ADULT | Pain Management|Critical Care|Quality Improvement | BEHAVIORAL: Audit and Feedback|BEHAVIORAL: Toolbox | Change from proportion of patient shifts during which pain has been adequately managed, "Adequately managed" is defined: pain measured AND (acceptable pain score OR (unacceptable pain score AND normalized within 1 hour)). The primary outcome measure is a composite score of four quality indicators (= secondary outcome measures).The measure is limited to only patients' first 12 shifts to prevent bias from patients with a long stay. There are 3 shifts in 1 day., 9 months | This study evaluates the addition of a quality improvement toolbox to an online audit and feedback intervention in Dutch intensive care units. The toolbox comprises for each quality indicator (e.g., percentage of patients per shift whose pain is measured) a list of potential bottlenecks in the care process (e.g., staff is unaware of the prevailing guidelines for measuring pain every shift), associated recommendations for actions to solve mentioned bottlenecks (e.g., organize an educational training session), and supporting materials to facilitate implementation of the actions (e.g., a slide show presentation discussing the importance and relevance of measuring pain every shift). Half of the participating intensive care units will only receive online feedback, while the other half will additionally gain access to the integrated toolbox to facilitate planning and executing actions. |
NCT00533000 | ALL | ADULT, OLDER_ADULT | Postoperative Complications|Randomized|Prevention|Smoking Cessation | PROCEDURE: Smoking cessation | Frequency of any postoperative complication, 1 month | The primary aim of this study is to evaluate the effect of preoperative smoking cessation on postoperative complications among patients undergoing surgery. Secondary aims are to evaluate effect on wound complications, short and long term effects including abstinence rate, pain, quality of life and effects on the immune system. |
NCT01530893 | MALE | ADULT, OLDER_ADULT | Cardiovascular Disease Risk Reduction | DIETARY_SUPPLEMENT: Flavanone - supplement|OTHER: Flavanone - food|OTHER: Flavanone - placebo|DIETARY_SUPPLEMENT: Isoflavone - supplement|OTHER: Isoflavone - food|OTHER: Isoflavone - placebo|DIETARY_SUPPLEMENT: Isoflavone - metabolite supplement|DIETARY_SUPPLEMENT: Flavan-3-ol - supplement|OTHER: Flavan-3-ol - food|OTHER: Flavan-3-ol - placebo|DIETARY_SUPPLEMENT: Anthocyanin - supplement|OTHER: Anthocyanin - food|OTHER: Anthocyanin - placebo | Change from baseline in blood vessel control (pressure and endothelial function) at time points coinciding with postprandial [anticipated] peak plasma flavonoid concentration., Assessment of vascular function, acute postprandial; up to 24 hours, dependent on flavonoid sub-classification studied | The primary aim of this placebo-controlled study is to determine whether flavonoids beneficially affect markers of cardiovascular disease risk in healthy subjects at elevated cardiovascular risk.
The underlying mechanisms of action of flavonoids will be assessed on blood biomarkers and we will assess the effects of the food matrix, and aspects of isoflavone metabolism. |
NCT00201734 | ALL | ADULT, OLDER_ADULT | Tumors|Unknown Primary Tumors|Adenocarcinoma | DRUG: Capecitabine|DRUG: Carboplatin|DRUG: Paclitaxel | Maximum Tolerated Dose in Phase I Portion of Study, Determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks carboplatin., Every 3 weeks, for up to 24 weeks|Objective Response Rate (ORR) for the Phase II Portion of the Study. CR+PR Per RECIST v1.0 Criteria Using a Single Arm , Two Stage Minimax Design., Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, Every 3 weeks, for up to 24 weeks | This study will determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks with carboplatin. |
NCT00728767 | ALL | ADULT, OLDER_ADULT | Alcohol Abuse | OTHER: Brief intervention|OTHER: Control group | Reduction of 25% in self reported alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the intervention group. In the control group we expect that 10% will reduce their consumption equivalent., 6 and 12 months | The purpose of the study is to determine whether a brief intervention (a short conversation build on the principles of motivational interviewing) is effective in lowering self reported alcohol use in heavy drinkers. |
NCT02404311 | ALL | ADULT | HIV Infection | BIOLOGICAL: ALVAC-HIV|BIOLOGICAL: Bivalent Subtype C gp120/MF59®|BIOLOGICAL: ALVAC-HIV (vCP2438) Placebo|BIOLOGICAL: Bivalent gp120/MF59® Placebo | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen, Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\] The maximum grade observed for each symptom over the time frame is presented., Measured through 3 days after participants' last vaccination at Month 0,1,3, and 6|Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen, Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\], Measured through 3 days after each vaccination at Month 0, 1, 3, and 6|Part A: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity, From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm, Measured through Month 18|Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity, From the study product discontinuation form, study product administration reasons are tabulated by treatment arm, Measured through the Month 12 vaccination|Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher, Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown., Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12|Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT, For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population., Time Frame: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12|Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine, For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population., Time Frame: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12|Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils, For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population., Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12|Part A: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay, Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI., Measured at Month 6.5|Part A: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay, Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation., Measured at Month 6.5|Part A: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen, Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen., Measured at Month 6.5|Part A: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen, Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation., Measured at Month 6.5|Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry., PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p\<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high., Measured at Month 6.5|Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen., Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. Percentage of T-cells expressing cytokines are summarized for positive responders only., Measured at Month 6.5|Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study, Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. For each participant, the maximum grade observed for each symptom over the time frame is presented., Measured through 3 days after the Month 30 vaccination|Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study, Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]. For each participant, the maximum grade observed for each symptom over the time frame is presented., Measured through 3 days after the Month 30 vaccination|Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity, From the study termination form, early termination reasons associated with an AE are tabulated by treatment arm, Measured through Month 36|Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher, Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown., Time Frame: Measured during screening for part B, and 2 weeks after vaccination at Month 30|Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT, For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population., Measured during screening for part B, and 2 weeks after vaccination at Month 30|Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine, For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population., Measured during screening for part B, and 2 weeks after vaccination at Month 30|Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils, For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population., Measured during screening for part B, and 2 weeks after vaccination at Month 30|Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen., Measured at Month 30.5|Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation., Measured at Month 30.5|Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen., Measured at Month 30.5|Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation., Measured at Month 30.5|Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by peptide pool., Measured at Month 30.5|Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. Percentage of T-cells expressing cytokines are summarized for positive responders only., Measured at Month 30.5 | The HIV Vaccine Trials Network (HVTN) is doing a study to test a new HIV vaccine combination. HIV is the virus that causes AIDS.
252 people are taking part in this study at multiple sites. The US National Institutes of Health (NIH) is paying for the study.
The investigators are doing this study to answer several questions.
* Are the study vaccines safe to give to people?
* Are people able to take the study vaccines without becoming too uncomfortable?
* How do people's immune systems respond to the study vaccines? (Your immune system protects you from disease.) |
NCT03500536 | ALL | ADULT, OLDER_ADULT | Depression|Anxiety|Primary Health Care | BEHAVIORAL: IntelliCare | Symptoms of depression, Using the PHQ-9 screener, 8 weeks | The clinical study is meant to optimize the mobile intervention, to develop a robust implementation plan for the mobile intervention within primary care, and to conduct an effectiveness trial, randomizing 128 participants in order to understand effect on severity of depression and anxiety symptoms, cost-effectiveness, and usability of mobile apps. |
NCT00265083 | ALL | ADULT, OLDER_ADULT | Spondylitis, Ankylosing | BIOLOGICAL: golimumab|BIOLOGICAL: Golimumab (CNTO 148); placebo|BIOLOGICAL: golimumab | Assessment in Ankylosing Spondylitis 20 Responders at Week 14, Number of patients who achieved a 20% improvement and at least 1 absolute improvement on a 0 to 10 cm scale from baseline to Week 14 in at least 3 of the 4 domains: patient global, total back pain, function or inflammation., Week 14 | The purpose of this study is to evaluate the safety and efficacy of subcutaneous injections (under the skin) of golimumab for the treatment of active ankylosing spondylitis \[AS(arthritis of the spine)\]. Efficacy will be measured by reduction in the signs and symptoms of active AS, including effects on back pain and stiffness, physical function, range of motion in the spine, quality of life, and rate of spine damage or fusion on x-ray. |
NCT01594749 | ALL | ADULT, OLDER_ADULT | Chemotherapy-Induced Nausea and Vomiting (CINV) | DRUG: Fosaprepitant dimeglumine|DRUG: Fosaprepitant Placebo|DRUG: Dexamethasone|DRUG: Ondansetron|DRUG: Dexamethasone Placebo|DRUG: Ondansetron Placebo|DRUG: Rescue Therapy | Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC), A Complete Response was defined as no vomiting and no use of rescue medication., 25 to 120 hours after initiation of MEC|Percentage of Participants With Infusion-site Thrombophlebitis, The percentages of participants with infusion-site thrombophlebitis are presented. Thrombophlebitis was defined as a condition affecting a superficial vein used for an IV infusion, associated with red color, hardness upon palpation, and the presence of a tender cord and possible fever., Day 1 through Day 17, inclusive|Percentage of Participants With Severe Infusion-site Reactions, The percentages of participants with severe infusion-site reactions, including severe site pain, or severe site redness (erythema) or severe site hardness (induration) are presented., Day 1 through Day 17, inclusive | This study aims to demonstrate that, when given concomitantly with a 5-hydroxytryptamine 3 (5-HT3) antagonist and a corticosteroid, a single 150 mg intravenous (IV) dose of fosaprepitant given on Day 1 is superior to the control regimen of 5-HT3 antagonist and corticosteroid only, in preventing chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC). |
NCT00279201 | ALL | ADULT, OLDER_ADULT | Diabetes Mellitus, Type 2 | DRUG: Insulin glargine|DRUG: Lispro Low Mix|DRUG: Lispro Mid Mix|DRUG: Lispro | INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c), Endpoint (Initiation: Week 24)|MAINTENANCE: Duration of Time HbA1c Maintained at Goal by Initiation Regimen (Insulin Glargine or Lispro Low Mix), HbA1c goal: HbA1c ≤7.0% or HbA1c \>7.0% but increased \<0.4% from last HbA1c ≤7.0%, Endpoint (Last Observation Carried Forward [LOCF]) (Maintenance: up to 2.5 years)|ADDENDUM: 24-Week Endpoint HbA1c, HbA1c at 24-week endpoint in Intensification Addendum of the trial., Endpoint (Addendum) (24 weeks: Week 48) | This study will compare insulin lispro low mixture \[LM\] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled.
This study will also determine whether the safety of insulin lispro LM and any side effects that might be associated with it are different from those observed with insulin glargine, both in combination with the patient's oral diabetes medications.
The addendum study (Intensification Addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine. |
NCT02972619 | ALL | ADULT, OLDER_ADULT | Hypertension|Cardiovascular Disease | OTHER: Structured Multicomponent Intervention (MCI) | Change in Systolic Blood Pressure from baseline to final follow-up at 24 months, Baseline to 2 years | Background: Hypertension is a serious public health problem responsible for significant mortality and morbidity from cardiovascular disease. In Singapore, 1 in 4 adults age 30 years or older suffer from hypertension. Nearly half of these patients have uncontrolled hypertension and only 50% of individuals are on antihypertensive treatment. Our study aims to evaluate the effectiveness, cost effectiveness and impact on medication adherence of a well-structured program using multicomponent intervention for hypertension control aimed at overall cardiovascular risk reduction among individuals with hypertension attending the polyclinics in Singapore, compared to existing services. Such a program is expected to be cost-effective in terms of improving hypertensive individuals' outcomes, and to be potentially scalable and sustainable.
Methods/design: Cluster randomized trial of 8 of the nine SingHealth Polyclinics randomized to intervention or usual care (4 each) and followed up for 2 years post randomization
Intervention: The structured multicomponent primary care program comprises of: 1) algorithm-driven antihypertensive treatment for all hypertensive individuals and using fixed-dose combination (FDC) and lipid-lowering medication for high-risk hypertensive individuals, 2) motivational conversation for high-risk hypertensive individuals, 3) Follow-up of all hypertensive individuals on improving blood pressure (BP) as a primary outcome and other cardiovascular risk factors as a secondary outcome, and 4) discounts on FDC antihypertensive medication
Usual care: The participants attending polyclinics randomized to usual care will continue to receive treatment from the health providers according to existing practices. The hypertensive individuals will also continue to pay for the services (physician or nurse consultation) as per their existing model of reimbursement.
Participants: A total of 1000 participants will be recruited, 125 from each of the 8 polyclinics. Recruitment will be in batches of 4 and 4 clinics sequentially (balanced by randomization group).
Outcomes: All hypertensive individuals will be assessed by trained outcomes assessors independent to treatment at baseline, 1-year and 2-yeat post randomization. The primary outcome will be the change in systolic blood pressure from baseline to 2 years. Primary Cost-Effectiveness measures will be- 1) Incremental cost per mm Hg systolic BP reduction from baseline to end of follow-up at two years post randomization; 2) incremental cost per projected CVD disability adjusted life years (DALYs) averted and quality adjusted life years (QALYs) saved, and 3) incremental cost per change in cardiovascular risk score from baseline to final follow-up at two-year post. The impact of effect on adherence to antihypertensive and lipid medication will be measured using data on adherence obtained from polyclinic pharmacy records and clinic notes. An average of percent adherence to antihypertensive and lipid lowering will be computed as a composite score. The change in percent composite adherence to antihypertensive and lipid medications from baseline to follow up will be compared between the intervention and control groups. |
NCT03347279 | ALL | CHILD, ADULT, OLDER_ADULT | Asthma | BIOLOGICAL: Experimental: Tezepelumab|OTHER: Placebo | Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma, The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. The analysis is based on the primary population (Full Analysis Set), From randomisation to Study Week 52.|Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma in Subjects With Baseline Eosinophils < 300 Cells/uL, The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. This analysis is based on subjects with baseline eosinophils \< 300 cells/uL, From randomisation to Study Week 52. | A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma |
NCT02000947 | ALL | ADULT, OLDER_ADULT | NSCLC|Non-small Cell Lung Cancer|Lung Cancer | DRUG: MEDI4736|DRUG: Tremelimumab|DRUG: tremelimumab | Number of subjects reporting adverse events, The number of subjects reporting adverse events (AEs) and number (percentage) of subjects reporting serious adverse events (SAEs) as graded by CTCAE Version 4.03, Screening through 90 days after the last dose of study medication|Objective response, Best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as defined as the best response among all overall responses recorded from the start of treatment until progression, or the last evaluable disease assessment in the absence of progressive disease (PD) prior to the initiation of subsequent anti-cancer therapy, or discontinuation from the study, whichever occurs first., At least 24 weeks as compared to baseline|Number of subjects experiencing dose-limiting toxicities (DLTs), The maximum tolerated dose (MTD), which is the highest dose within a cohort where no more than 1 out of 6 subjects experience DLTs or the highest protocol-defined dose for each agent in the absence of exceeding the MTD, will be evaluated using the following safety assessments: adverse events, serious advents, laboratory evaluations, vital signs, physical examinations, and electrocardiogram (ECG) results. Measurements will be aggregated to determine whether a subject has experienced a DLT as assessed by the investigator., Depending upon the cohort, the DLT evaluation period is from the 1st dose of study medication until (1) the 3rd dose of MEDI4736 and tremelimumab (2) the 2nd dose of MEDI4736 and tremelimumab or (3) the 3rd dose of MEDI4736 and 2nd dose of tremelimumab | The purpose of this study is to determine if MEDI4736 will be adequately tolerated in combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC). |
NCT00363324 | ALL | ADULT, OLDER_ADULT | Acute Myocardial Infarction | PROCEDURE: intracoronary injection of bone marrow cells | Arrhythmia risk variables|left ventricular function|restenosis assessed by IVUS | This study is aimed to assess the effect of bone marrow cells on arrhythmia risk variables in patients with a acute myocardial infarction. |
NCT00925743 | ALL | ADULT, OLDER_ADULT | Solid Cancer | DRUG: cabazitaxel (XRP6258) | Dose Limiting Toxicities (DLT)'s of the combination of cabazitaxel and cisplatin (part 1), first cycle (i.e.3 weeks)|Objective response ratio (Complete response (CR) and partial response (PR)) (part 2), up to 6 cycles, ie 18 weeks|Pharmacokinetics (PK) of cabazitaxel (part 3 and 4), up to 6 cycles, ie 18 weeks | This study is designed as a phase 1, multicenter, open-label, single arm, dose-escalation, study of Cabazitaxel in combination with cisplatin, to determine safety, pharmacokinetics (PK), and efficacy in solid tumors (parts 1 and 2) and single sequence, two-treatment, crossover studies to determine the effect of strong CYP3A4 inhibition and induction on the PK of Cabazitaxel in patients with solid tumors (part 3 and part 4, respectively).
There are 4 parts to the study:
Part 1: Determine the Dose Limiting Toxicities (DLT)'s and Maximum Tolerated Dose (MTD) based on safety.
Part 2: Determine the anti-tumor activity of the combination regimen at the Maximum Tolerated Dose (MTD) in an extended cohort of patients.
Part 3: Determine the effect of a strong CYP3A4 inhibitor (ketoconazole) on the pharmacokinetic (PK) of Cabazitaxel.
Part 4: Determine the effect of a strong CYP3A4 inducer (rifampin) on the pharmacokinetic (PK) of Cabazitaxel. |
NCT03138811 | ALL | ADULT | Asthma | DRUG: CSJ117|DRUG: Placebo Comparator | Number of adverse events and serious adverse events, An AE is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that is given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug are classified as a treatment emergent adverse event., 12 weeks|Late asthmatic response as measured by the AUC for time adjusted percent decrease in FEV1, Late asthmatic response (LAR) is considered a ≥ 15% fall in FEV1 between 3 and 7 hours after an allergen inhalation challenge. The AUC for time adjusted percent decrease in FEV1 will be compared between CSJ117 and placebo groups., 12 weeks|Late asthmatic response as measured by the maximum percentage decrease in FEV1, Late asthmatic response (LAR) is considered a ≥ 15% fall in FEV1 between 3 and 7 hours after an allergen inhalation challenge. The maximum percentage decrease in FEV1 will be compared between CSJ117 and placebo groups., 12 weeks | This is a non-confirmatory, randomized, subject and investigator blinded, placebo-controlled, parallel-design, multi-center bronchoprovocation study. Approximately 55 subjects with mild stable atopic asthma who exhibit an EAR and LAR to a common inhaled allergen will receive multiple once daily doses of inhaled CSJ117 or placebo over 12 weeks. Two sequential dose cohorts are planned for this study, Cohort 1 and Cohort 2. Cohort 2 will be split into two parts, Cohort 2a and 2b |
NCT00828087 | ALL | CHILD, ADULT, OLDER_ADULT | Myocardial Infarction | DRUG: Everolimus Eluting Coronary Stent System|DEVICE: cobalt chromium balloon expandable stent ( non drug eluting stent Arm) | Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year., 1 year | This study is a prospective, randomized controlled, single blind, two-arm, multi center clinical evaluation. A total of 1500 patients will be enrolled in the study.
Patient randomization will be to one of the two treatment arms: Everolimus arm or Non drug eluting stent arm. The objective of this study is to assess the safety and performance of the Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable stent in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction. |
NCT00006164 | ALL | ADULT, OLDER_ADULT | Chronic Hepatitis c|Cirrhosis, Liver|Fibrosis, Liver|Hepatic Cirrhosis | DRUG: Peginterferon alfa-2a + Ribavirin|DRUG: Peginterferon alfa-2a | Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points, Progression of liver disease within 1400 days as indicated by death, hepatic decompensation (variceal hemorrhage; ascites; spontaneous bacterial peritonitis; hepatic encephalopathy), hepatocellular carcinoma, a Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater decompensation), or for patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study, 1400 days (3.85 years) post randomization|Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies, For patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study (collected at Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization), 1400 days (3.85 years) post randomization|Death From Any Cause, 1400 days (3.85 years) post randomization|Development of Hepatocellular Carcinoma (HCC), A diagnosis of development of hepatocellular carcinoma (HCC) was based on either
1. Histology showing HCC (from a biopsy, surgery, or autopsy) or
2. A new hepatic defect on imaging with an alpha-fetoproteion (AFP) level rising to \> 1,000 ng/ml., 1400 days (3.85 years) post randomization|Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits, Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater hepatic decompensation), 1400 days (3.85 years) post randomization|Variceal Hemorrhage, A gastrointestinal hemorrhage which is believed by the investigator to be due to bleeding esophageal or gastric varices. In general, an endoscopy will have been performed and will have revealed either direct evidence of variceal bleeding (bleeding varix, red wale sign) or historical evidence for significant upper gastro-intestinal bleeding plus upper endoscopy revealing moderate varices and no other site of bleeding is identified, 1400 days (3.85 years) post randomization|Ascites, Any abdominal fluid which is:
1. Mild, moderate or marked on ultrasound; or
2. Progressive on serial physical examinations; or
3. Requires diuretic therapy. To meet the definition of ascites, abdominal fluid that is "mild" ("barely detectable") on physical examination requires ultrasound confirmation that is "mild", "moderate" or "marked" ascites. Ultrasound reports of minimal fluid around the liver do not meet the definition., 1400 days (3.85 years) post randomization|Spontaneous Bacterial Peritonitis, Any episode of spontaneous ascitic infection diagnosed on the basis of elevated neutrophil count (\> 250/ml) in paracentesis fluid or positive bacterial cultures and clinical diagnosis in the absence of white blood cell (WBC) availability., 1400 days (3.85 years) post randomization|Hepatic Encephalopathy, Any mental status alteration which is deemed by the investigator to be due to portosystemic encephalopathy, whether occurring during a provoked episode (GI bleeding, diuretics, usual sedative doses), or spontaneously (without apparent cause)., 1400 days (3.85 years) post randomization | The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with Peginterferon alfa-2a and Ribavirin. Patients who respond to this 6 month treatment will continue to be treated for an additional 6 months.
Patients who do not respond to this treatment will be eligible for the long-term maintenance phase of this study where patients will be randomly selected to be treated with Peginterferon alfa-2a or to discontinue treatment for 3.5 years. Patients in both arms of this study will be followed closely with quarterly study visits.
The combination of peginterferon plus ribavirin has recently been approved by the FDA for treatment of chronic hepatitis C. Patients who remain HCV-RNA positive after being treated for at least 6 months with peginterferon and ribavirin outside of this study may be eligible to directly enter the randomized portion of the HALT-C Trial.
The HALT-C study is designed to determine if continuing interferon long-term over several years will suppress Hepatitis C virus, prevent progression to cirrhosis, prevent liver cancer and reduce the need for liver transplantation. |
NCT00494702 | ALL | CHILD | Birth Asphyxia|Premature Birth | PROCEDURE: Resuscitation|PROCEDURE: Resuscitation | Achievement of a targeted saturation of 85% at 15 min of life., 30 min | The investigators hypothesize that using low oxygen concentrations during resuscitation of extremely premature infants will avoid oxidative stress derived damage and improve outcome. |
NCT04821960 | ALL | ADULT, OLDER_ADULT | Anxiety and Fear | BEHAVIORAL: Tailored Mindfulness Program for Fear of Memory Loss|BEHAVIORAL: Conventional Mindfulness Program | Fear and Avoidance of Memory Loss (FAM) Scale Score at Follow-up, A 24-item scale to assess fear of memory loss. Scores range from 24-120 points with a higher score indicating a higher fear of memory loss., 10 Weeks Post-Baseline|Fear of Alzheimer's Disease Scale (FADS) Score at Follow-up, A 30-item scale to assess fear of Alzheimer's disease. Minimum score = 0; maximum score = 120. A higher score indicates a greater fear of developing Alzheimer's Disease., 10 Weeks Post-Baseline | This study is a randomized control study to determine the impact of a tailored, web-based mindfulness program to reduce anxiety and increase the quality of life in older adults experiencing dementia-related fears, relative to a conventional meditation program. |
NCT03242785 | ALL | ADULT, OLDER_ADULT | Hypertension|Adjustment|Adherence, Medication | OTHER: Self-monitoring/Self-titration | Mean systolic blood pressure (SBP)., Difference in mean systolic blood pressure, in mmHg. At 12 months of follow-up between the intervention and control groups, determined at physicians' practice with a validated automatic electronic sphygmomanometer, 12 months from start of intervention | The ADAMPA study is a pragmatic randomized clinical trial which aims to evaluate the effectiveness of an intervention based on self-monitoring and self-titration of medication in poorly controlled hypertensive patients 40 years and older. The total duration of the study is 3 years, with 6 months of enrolment and 1 year of follow-up to measure the primary endpoint (Difference in mean systolic blood pressure, in mmHg, between the intervention and control groups). |
NCT01685866 | ALL | CHILD | Cardiovascular Diseases | DEVICE: Vein-Viewer Vision | reduce the time necessary to find the venous access during inhalation anesthesia induction, 1 day of anesthesia | Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see peripheral veins in children having forecasted difficult venous access and could facilitate the venous access.The main goal is to reduce the time necessary to get a venous access during the inhalation anesthesia induction. |
NCT04006288 | ALL | ADULT, OLDER_ADULT | Coronary Artery Disease | DRUG: Clopidogrel|DRUG: Prasugrel|DRUG: ticagrelor|DRUG: aspirin|DRUG: rivaroxaban | Maximal Platelet Aggregation (MPA%) by Light Transmittance Aggregometry (LTA), The primary end point of this study will be the comparison of MPA% measured by LTA using the CATF cocktail as agonist between DAPT and low-dose rivaroxaban plus aspirin for each DAPT regimen, 30 days | Recent studies indicate that anti-factor-Xa inhibition with low-dose rivaroxaban may have a role in the reduction of ischemic recurrences in patients with atherosclerotic disease manifestations. The objectives of this investigation are to assess the feasibility of switching from a DAPT to DPI regimen and to compare the pharmacodynamic profiles of these treatment regimens. This will be a prospective study conducted in cohorts of patients with CAD on treatment per standard of care with DAPT. Patients will be randomized to either maintain DAPT or to DPI. DPI consists in treatment with aspirin (81mg/qd) plus rivaroxaban (2.5mg/bid). |
NCT01009788 | ALL | ADULT, OLDER_ADULT | Breast Cancer|Metastatic Breast Cancer|BRCA1 Gene Mutation|brca2 Gene Mutation | DRUG: ABT-888|DRUG: temozolomide | To determine the objective response rate (ORR) of ABT-888 and temozolomide (TMZ) in metastatic breast cancer., To determine the percentage of all enrolled patients who have a partial or complete response, 2 years|To determine Safety and Efficacy in an Expansion Cohort of BRCA1/2 Mutation Carriers., An expansion cohort of 20 additional patients with BRCA1/2 Deleterious Mutations will be evaluated to further assess safety and efficacy of the combination of ABT888 and Temozolomide in metastatic breast cancer., 2 years | The purpose of this research study is to find out if the combination of ABT-888 and temozolomide is safe and effective in treating patients with metastatic breast cancer. ABT-888 works by obstructing a DNA enzyme called poly (ADP-ribose) polymerase (PARP) which helps repair cancer cells damaged by chemotherapy. By blocking the PARP enzyme, the cancer cells are unable to repair themselves and as a result die. The other drug in this study is temozolomide. Temozolomide is designed to damage DNA in order to prevent cancer cells from reproducing. Because PARP inhibitors, such as ABT-888, prevent cancer cells from repairing their own DNA, they enhance the potential of chemotherapy therapy like temozolomide to induce cell death. The combination of ABT-888 and temozolomide has been used in a clinical trial for treatment of other cancers and information for this research study suggests that the combination may help to inhibit growth in breast cancer.
ONLY THE EXPANSION COHORT BELOW IS RECRUITING:
BRCA CARRIER EXPANSION COHORT: The purpose of the expansion cohort is to further evaluate the activity and safety of this combination in BRCA mutation carriers with metastatic breast cancer. |
NCT03990181 | ALL | ADULT, OLDER_ADULT | Iron Metabolism Disorders|Iron Overload|Polyphenols | DIETARY_SUPPLEMENT: meal matrix & NPPS|DIETARY_SUPPLEMENT: meal matrix & CS|DIETARY_SUPPLEMENT: no-matrix & NPPS|DIETARY_SUPPLEMENT: no-matrix & CS | change from baseline in the isotopic ratio of iron in blood at week 2, The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes, baseline, 2 weeks|change from baseline in the isotopic ratio of iron in blood at week 4, The change in the isotopic ratio of iron will be measured after administration of a test meal/drink including iron isotopes, 2 weeks, 4 weeks | Polyphenolic compounds are very strong Inhibitors of non-heme iron absorption, as they form insoluble complexes with ferrous iron. Patients with hereditary hemochromatosis (HH) have an increased intestinal non-heme iron absorption due to a genetic mutation in the regulatory pathway, leading to excess iron in the body. This study investigates the inhibitory effect of a natural polyphenol Supplement in participants with HH. |
NCT01367704 | MALE | CHILD, ADULT | Violence|Abuse | BEHAVIORAL: "Coaching Boys Into Men" program | Change From Baseline to 3 Months Using the Recognition of Abusive Behavior Scale, Recognition of disrespectful and harmful behaviors against girls as abusive comparing baseline and follow up mean scores, using a 5-point Likert-like scale ranging from "not abusive" to "extremely abusive" (minimum = 1 and maximum = 5). This scale was developed by Silverman et al to assess perceptions of the degree of abusiveness of specified relationship behaviors and modeled as a mean of responses to 12 items., 3 months|Change From Baseline to 3 Months Using the Gender Equitable Attitudes Scale, Assessment of gender-equitable attitudes comparing baseline mean score with follow up mean score, using a 5-point Likert-like scale ranging from "strongly agree" to "strongly disagree" (minimum = 1 and maximum = 5). This scale includes questions modified from Barker's Gender-Equitable Norms Scale and modeled as a mean of responses to 11 items., 3 months|Change From Baseline to 3 Months Using the Intentions to Intervene Scale, Proclivity to intervene when witnessing disrespectful and harmful behaviors among peers comparing baseline and follow up mean scores, using a 5-point Likert-like scale ranging from "very unlikely" to "very likely" (minimum = 1 and maximum = 5). This scale was investigator developed by Miller (PI) et al to assess participants report of how likely they would be to do something to stop the behavior and modeled as a mean of 8 items., 3 months | Despite the high prevalence of adolescent relationship abuse (ARA) reported among adolescent females and substantial reports of perpetration by young males, effective prevention programs to prevent ARA are limited. Male athletes are an important target for prevention efforts given their higher rates of abuse perpetration compared to non-athlete peers as well as their social influence among their peers. This cluster-randomized school-based investigation examines the effectiveness of a program for the primary prevention of ARA. "Coaching Boys into Men" (CBIM) is a social norms theory-based program intended to alter norms that foster ARA perpetration, promote bystander intervention, and reduce ARA perpetration by engaging athletic coaches as positive role models to deliver violence prevention scripts and tools to high school age male athletes. Coaches receive a 60-minute training session to administer the intervention to their athletes via 11 lessons across a sport season. Trained high school coaches talk to their male athletes about 1) what constitutes disrespectful and harmful vs. respectful behaviors, 2) promoting more gender-equitable attitudes, and 3) modeling bystander intervention when disrespectful behaviors toward women and girls are witnessed. The current investigation evaluates the intervention in 16 urban high schools randomized either to receive the CBIM program (i.e., intervention schools, n=8) or to a control condition (n=8). Baseline computer-based surveys are collected for all intervention and control site student athletes entering grades 9 through 12 at the start of each of three sports seasons across Year 1 (Time 1). Follow up surveys are collected for these same athletes at the end of their first sports season (Time 2). Participating athletes in grades 9 - 11 at baseline are re-surveyed 12 months after Time 1 to examine the longer term effects of the CBIM intervention (Time 3; N of athletes completing all 3 waves of data collection = 1500). Primary assessment of intervention effects are based on intent-to-treat estimates, utilizing generalized linear mixed models to account for clustering arising from school randomization. Hypothesized outcomes for male athletes include a) an increase in recognition of what constitutes abusive behaviors, b) more gender-equitable attitudes, c) an increase in intentions and reports of bystander intervention regarding ARA, and through these intermediate outcomes, d) a decrease in perpetration of ARA among adolescent male athletes. |
NCT00974155 | ALL | ADULT, OLDER_ADULT | Depression | DRUG: Escitalopram, venlafaxine, lithium|DRUG: Escitalopram, venlafaxine | Remission from MDD on day 56, defined as a HAMD17 sum score ≤ 7, in non-improvers on day 14 (n=192), 8 weeks | The EMC trial investigates for the first time prospectively whether Major Depression Disorder patients with non-improvement after 14 days of antidepressive treatment with EMC are more likely to become remitters compared to patients treated according to current guidelines, i.e., with a medication change after 28 days of treatment in case of non-response. |
NCT00469599 | ALL | ADULT, OLDER_ADULT | Secondary Hyperparathyroidism|Chronic Kidney Disease|Vitamin D Deficiency | DRUG: paricalcitol|DRUG: alfacalcidol | The effect of alfacalcidol and paricalcitol on intact parathyroid hormone level and the tendency towards hyperphosphatemia and hypercalcemia, 16 weeks | The purpose of this study is to compare alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients. |
NCT01910038 | ALL | ADULT, OLDER_ADULT | Giant Cell Arteritis | DRUG: corticoids+ tocilizumab 8mg/Kg/4 weeks | Percentage of patients in remission with a dose of prednisone ≤ 0.1 mg/kg/day, Remission: absence of symptoms attributable to Giant Cell Arteritis and normalization of inflammatory markers (CRP\<10 mg/L and ESR\<30 mm/h).
Relapse: recurrence of symptoms attributable to active GCA and/or increased levels of inflammatory markers (CRP≥10 mg/L and/or ESR≥30 mm/h). Elevation of inflammatory markers in the absence of GCA symptoms was considered relapse if it persisted at two time points at 1 week apart without any other obvious etiology than GCA., Week 26 | It has been reported that around 40% of GCA patients are able to decrease the prednisone dose until 0.1 mg/Kg/d or less after 6 months of treatment. In this study, we hypothesized that adding 3 months of tocilizumab to prednisone could increase the percentage from 40 to 70%. |
NCT03040830 | FEMALE | ADULT | Progesterone Luteal Support in ICSI|Embryo Transfer | DRUG: Progesterone 100 IM/day | difficult embryo transfer, presence of blood on embryo transfer catheter and or need for sounding or dilating the cervix to pass the embryo transfer catheter to the endometrial cavity, 3 minutes | The study aims to know whether starting progesterone luteal support in intra cytoplasmic sperm injection (ICSI) cycles on the day of ovum pickup affects the degree of difficulty of embryo transfer compared with starting luteal support on day of embryo transfer |
NCT01212107 | ALL | ADULT, OLDER_ADULT | Advanced Cancer | DRUG: FGF Receptor|DRUG: Phosphate Binders | Recommended Dose for Phase 2 Studies : Maximum Tolerated Dose (MTD), MTD was determined after the evaluation of Part A portion of the trial. Dose escalation proceeded at 1.3 times the preceding cohort once a Grade 3 non-laboratory toxicity or Grade 2 laboratory toxicity was noted in ≥ 1 participant until MTD was achieved. Doses up to 24 mg (48 mg/day) were evaluated in Part A. The effects at this dose and at 18 mg (36 mg/day) suggested that a reasonable number of participants might not tolerate LY2874455 for chronic administration at these dose levels because of the constellation of effects observed individually or in combination in participants at these dose levels. Therefore, the dose of 16 mg BID of LY2874455 (total dose 32 mg per day) was selected as the initial dose for Part B. Selection of the dose level was based on the tolerability of this dose and without specific toxicities identified., Baseline Up to 32 Weeks | The study is to determine the recommended Phase 2 regimen of study drug that may be safely administered to participants with advanced and or metastatic cancer. The study consists of two parts: a dose escalation and a dose confirmation. |
NCT00322452 | ALL | ADULT, OLDER_ADULT | Non-Small Cell Lung Cancer | DRUG: Gefitinib|DRUG: Carboplatin|DRUG: Paclitaxel | Median Progression Free Survival (PFS) in Months, PFS was defined as the interval from the date of randomization to the date of objective disease progression (as per RECIST) or the date of death (from any cause) in the absence of objective disease progression. The median PFS in months is presented here., Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008). | The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority. |
NCT01389414 | ALL | ADULT, OLDER_ADULT | Biliary Carcinoma | DRUG: Panitumumab plus GEMOX chemotherapy|DRUG: GEMOX chemotherapy | Progression-free survival, Progression-free survival (PFS), defined as the time from randomization to evidence of progression (RECIST, vers.1.1), death, or last radiographic assessment in absence of a PFS event., Every 8±1 Weeks until PD | This is a multi-centre phase II, open-label, randomized (1:1), parallel-arm, study of panitumumab in combination with chemotherapy (P-GEMOX) versus chemotherapy alone (GEMOX). Eligible subjects will be enrolled and randomized to receive first-line combination therapy consisting of panitumumab and GEMOX (experimental arm) or GEMOX alone (control arm).The ame of the Stuy is to evaluate the clinical activity of the P-GEMOX (Panitumumab and GEMOX) combination compared to GEMOX alone in patients with previously untreated surgically unresectable or metastatic biliary tract carcinoma (KRAS wild-type)and To evaluate the safety profile of the P-GEMOX combination; to assess the objective response rate; to assess overall survival; to study the correlation between biomarkers with activity and efficacy. |
NCT00951782 | ALL | ADULT, OLDER_ADULT | Chronic Obstructive Pulmonary Disease|Smoking | DEVICE: High frequency TMS|DEVICE: Sham TMS|DEVICE: Low frequency TMS | Nicotine consumption(number of cigarets per day and cotinine levels )and craving (questionaires)at end of treatment (3rd week), 3 weeks of treatment (and additional 34 weeks of maintenance & follow-up) | Deep transcranial magnetic stimulation (TMS) is currently being evaluated as a treatment option in major depression. It has been shown to be a safe procedure . Deep transcranial magnetic stimulation coils are designed to maximize the electrical field deep in the brain by the summation of separate fields projected into the skull from several points around its periphery. The device is planned to minimize the accumulation of electrical charge on the surface of the brain. Such accumulation can give rise to an electrostatic field that might reduce the magnitude of the induced electric field both at the surface and inside, thus reducing the depth penetration of the induced electric field . Deep transcranial magnetic stimulation could be more effective than repetitive transcranial magnetic stimulation due to its deeper penetration into brain tissues . The deeper penetration should produce greater action on nerve fibers connecting the prefrontal cortex to the limbic system.
The ability of high-frequency repetitive transcranial magnetic stimulation (rTMS) to alter dopaminergic neurotransmission in subcortical structures could explain recent reports, which suggest that it has the potential to reduce smoking and nicotine craving. Ecihhammer et al demonstrated a reduction in the number of cigarettes smoked and in the desire to smoke after a single rTMS treatment (Eichhammer et al., 2003). In addition, Johan et al in a cross-over, double-blind, placebo-controlled study demonstrated a reduction in cigarette consumption and desire to smoke after a single repetitive transcranial magnetic stimulation treatment (Johann et al., 2003). Recently, the investigators have finished a complete study on nicotine addiction using repetitive transcranial magnetic stimulation for 10 consecutive days. They have found that 10 days of rTMS reduced significantly better from placebo the number of cigarettes smoked, nicotine dependence and craving (Amiaz et al 2007, in preparation). Interestingly, some of the effects were stronger in the sub-group of patients that were presented with smoking-related pictures immediately prior to stimulation onset. Although, these results are interesting and exciting, they have two important caveats. First, only about 50%-60% of the smokers responded to the repetitive transcranial magnetic stimulation treatment. Second, among those responded to the treatment, only 10% had quit totally from smoking. Therefore, the potential therapeutic benefit of this treatment is limited. The investigators' hypothesis is that deep transcranial magnetic stimulation may be more efficient in smoking cessation due to it's deeper penetration and therefore it's capability to stimulate deeper fibers of the dopamine-reward-activating system. |
NCT00262847 | FEMALE | ADULT, OLDER_ADULT | Fallopian Tube Clear Cell Adenocarcinoma|Fallopian Tube Endometrioid Adenocarcinoma|Fallopian Tube Mucinous Adenocarcinoma|Fallopian Tube Serous Adenocarcinoma|Fallopian Tube Transitional Cell Carcinoma|Malignant Ovarian Mixed Epithelial Tumor|Ovarian Brenner Tumor|Ovarian Clear Cell Adenocarcinoma|Ovarian Endometrioid Adenocarcinoma|Ovarian Mucinous Adenocarcinoma|Ovarian Serous Adenocarcinoma|Ovarian Transitional Cell Carcinoma|Primary Peritoneal Serous Adenocarcinoma|Stage IIIA Fallopian Tube Cancer|Stage IIIA Ovarian Cancer|Stage IIIA Primary Peritoneal Cancer|Stage IIIB Fallopian Tube Cancer|Stage IIIB Ovarian Cancer|Stage IIIB Primary Peritoneal Cancer|Stage IIIC Fallopian Tube Cancer|Stage IIIC Ovarian Cancer|Stage IIIC Primary Peritoneal Cancer|Stage IV Fallopian Tube Cancer|Stage IV Ovarian Cancer|Stage IV Primary Peritoneal Cancer|Undifferentiated Fallopian Tube Carcinoma|Undifferentiated Ovarian Carcinoma | BIOLOGICAL: Bevacizumab|DRUG: Carboplatin|OTHER: Laboratory Biomarker Analysis|DRUG: Paclitaxel|OTHER: Placebo|OTHER: Quality-of-Life Assessment | Progression-free Survival, Median progression-free survival (PFS). Onset of progression could be based on radiographic (RECIST) criteria or rising CA-125 (GCIG criteria)., From study entry until first disease progression, death or date of last contact, up to 6 years | This randomized phase III trial studies carboplatin, paclitaxel, and bevacizumab to see how well they work compared to carboplatin, paclitaxel, and placebo in treating patients with stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin, paclitaxel, and placebo in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer. |
NCT04430608 | ALL | ADULT, OLDER_ADULT | Diabetes|Covid-19|Infection | DEVICE: Dexcom G6 | Time In Range (TIR) for blood glucose, TIR is presented in percent of time in which the participants' glucose values are in different glucose ranges., 1-2 weeks | This is a randomized controlled trial of isolated patients with diabetes admitted to Nordsjællands Hospital with or without COVID-19-pneumonia. A continuous glucose monitoring (CGM) based system with transmission of glucose data to a central system is used for remote monitoring of glucose levels and compared to standard finger-prick glucose. Blinded (to patients) CGM is mounted in the finger-prick group. |
NCT01856803 | ALL | ADULT | Leukemia, GVHD, ATG, Transplantation | DRUG: anti thymoglobulin | Incidence of acute GVHD, and chronic GVHD, 2 years | Age is a risk factor for graft-versus-host disease (GVHD) after human leukocyte antigen (HLA)-matched sibling allogeneic stem cell transplantation (allo-SCT). The incidence of acute GVHD is significantly higher in patients at 40 years of age or more than those at 18 to 39 years of age after allo-SCT. It was found that Anti-thymocyte globulins can be used for prophylaxis of both acute and chronic GVHD after allo-SCT.Prophylaxis of GVHD using ATG in patients at 40 years of age or more in matched sibling allo-SCT settings might significantly decrease the incidence of acute and chronic GVHD and the incidence of late effect after transplantation. |
NCT04089644 | ALL | ADULT, OLDER_ADULT | Hypotension | DEVICE: closed-loop system|DEVICE: Manual adjustment | Percentage of case Time in hypotension (MAP < 90% of the chosen MAP target)., Undertreatment. Percentage of time during surgery in hypotension. The MAP used to define hypotension will differ for each patient (individualized approach), At postoperative day 1 | Intraoperative hypotension can impact patient outcome. Vasopressors are usually used to correct hypotension and ensure adequate organ perfusion.
The investigators have recently developed an automated system (closed-loop system) to titrate vasopressor agents in surgical and intensive care patients.
The purpose of this study is to compare two strategies to correct hypotension based on an individual definition of hypotension (therefore, the target MAP used to define hypotension will differ for each patient (individualized approach):
1. Control group = standard practice ( manually adjusted norepinephrine infusion to correct hypotension and keep MAP within 90% of patient's baseline MAP
2. Intervention group = closed-loop (automated) vasopressor administration system will deliver norepinephrine using feedback from standard operating room hemodynamic monitor (EV1000 Monitor-Flotrac, Edwards Lifesciences, IRVINE, USA) to correct hypotension and keep MAP within 90% of patient's baseline MAP |
NCT03146520 | ALL | ADULT, OLDER_ADULT | Colorectal Cancer|Polyps|Other Cancers|Healthy | DEVICE: EarlyTect Colon Cancer | Clinical performance of EarlyTect Colon Cancer to detect colorectal cancer, Sensitivity and specificity of EarlyTect Colon Cancer to detect colorectal cancer (sensitivity: the ratio of positive cases in all CRC cases, specificity: the ratio of negative cases in all healthy controls), 1.5 years | Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical sensitivity and specificity in detection of colorectal cancer. |
NCT00096824 | ALL | ADULT, OLDER_ADULT | HIV Infections | BEHAVIORAL: Neurological assessment | null | The purpose of this study is to determine how often dementia and other neurological problems occur in people with HIV. Participants of ACTG A5175 will enroll in this study. |
NCT01183689 | ALL | ADULT | Weight Gain | BEHAVIORAL: Small Behavior Changes|BEHAVIORAL: Large Behavior Changes | Weight Changes From Baseline Over Follow-up., Mean weight change from baseline across an average planned follow-up of three years. These mean changes will be compared among the three arms of the trial., 3 years | The Study of Novel Approaches for Prevention (SNAP) is randomized trial designed to test whether behavioral interventions based on self-regulation can prevent weight gain in young adults (18-35 years; body mass index (BMI) 21-30 kg/m2). Two different self-regulation interventions for weight gain prevention will be compared in this trial; one intervention will focus on making small, consistent, changes in eating and exercise behavior to prevent weight gain or reverse weight gain if it occurs, whereas the other will emphasize larger changes in eating and exercise that occur periodically, with a goal of producing weight loss and thereby providing a buffer against anticipated weight gains. The primary aim of the trial is to test whether the magnitude of weight gain from baseline across an average three-year follow-up differs across the three groups, with the hypotheses that weight gain will be greater in the Control group than in either intervention and greater in the Small Changes than Large Changes group.
SNAP-E (Extension) will determine whether the effects of the intervention can be maintained over an additional 3 years (i.e. through a total of 6 years). |
NCT01458730 | ALL | ADULT, OLDER_ADULT | Central Nervous System Lymphoma | DRUG: Immunochemotherapy | Overall survival | The purpose of the study is to test the efficacy and tolerability of a multiagent chemotherapy treatment regimen without radiotherapy in patients with newly diagnosed lymphoma in the brain. |
NCT04078737 | ALL | ADULT, OLDER_ADULT | Stroke|Transient Ischemic Attack | DRUG: Ticagrelor and Aspirin|DRUG: Clopidogrel and Aspirin | Any new stroke events (ischemic stroke or hemorrhagic stroke) within 3 months, The aim is to assess the effects of ticagrelor plus aspirin versus clopidogrel plus aspirin on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in CYP2Y19 LOF alleles carriers with TIA or minor stroke., 3 months after randomization | The primary objective of this trial is to assess the effects of ticagrelor plus aspirin versus clopidogrel plus aspirin on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in CYP2Y19 LOF alleles carriers with TIA or minor stroke. |
NCT00570739 | ALL | ADULT, OLDER_ADULT | Type 2 Diabetes Mellitus|Hypercholesterolemia|Pre-diabetes | DRUG: Metformin HCl and Colesevelam Placebo|DRUG: Metformin HCl tablets and Colesevelam tablets|DRUG: Colesevelam placebo|DRUG: Colesevelam | Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects., Baseline to 16 weeks|Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks, Baseline to 16 Weeks | This is a 16-week double-blind, placebo-controlled (for colesevelam hydrochloride (HCl)) study in the type 2 diabetic subjects and pre-diabetic subjects. Diabetic participants will also be treated with open label, background,metformin HCl. Two-hundred sixty subjects with type 2 diabetes (T2DM) and 200 pre-diabetic subjects are planned to be be enrolled. Qualified subjects with T2DM will be randomized 1:1 to receive metformin HCl plus colesevelam HCl or metformin HCl plus placebo matching colesevelam HCl. Qualified pre-diabetic subjects will be randomized 1:1 to receive colesevelam HCl or matching placebo. |
NCT01551238 | ALL | ADULT | Obesity|Overweight|Overnutrition|Nutrition Disorders|Body Weight|Signs and Symptoms | DIETARY_SUPPLEMENT: Differences in protein content of meals|DIETARY_SUPPLEMENT: Differences in protein content of meals | energy expenditure, 48 hours|substrate oxidation, 48 hours|sleep, 48 hours | The purpose of this study is to determine energy expenditure and sleep in response to protein/carbohydrate and fat ratio of the diet over a short-term and long-term period of time. |
NCT02295072 | ALL | CHILD | Cognitive Function 1, Social|Mental Health Wellness 1|Obesity|Overweight | BEHAVIORAL: A 5-months physical exercise-based program | Changes in Brain function and structure using magnetic resonance imaging (MRI), 10-15 mins of high resolution scanning, 10 mins of resting state and 20 mins of Diffusion Tensor Imaging, 20 days during baselines and Post-evaluations (after intervention).|Brain and cognitive functioning assessment by electroencephalogram (EEG), Assessment of the processing information and speed trought event-related brain potentials, cognitive function using a EEG and doing two cognitive tasks of attention and working memory., 20 days during baselines and Post-evaluations (after intervention).|Cognitive performance (DKEFS test battery), Executive function assessment with a set of tests of the DKEFS test battery that provide an assessment of verbal and non-verbal intelligence, one's initiation of problem-solving behavior, fluency in generating visual patterns, creativity in drawing new designs, simultaneous processing in drawing the designs while observing the rules and restrictions of the task, and inhibiting previously drawn responses, spatial planning, rule learning, inhibition of impulsive and perseverative responding, cognitive inhibition, flexibility of thinking on a visual-motor sequencing task and relational memory, 20 days during baselines and Post-evaluations (after intervention).|Academic achievement, Academic achievement is assessed using final school recorded scores and the III Woodcock-Muñoz Battery which includes 5 reading tests, 4 oral tests, 4 mathematics tests, 4 written language tests and 4 tests of academic language., 20 days during baselines and Post-evaluations (after intervention). | The ActiveBrains project aims to examine whether a 5-months physical exercise program has benefits on cognition and brain, as well as on selected physical and mental health outcomes in preadolescent overweight/obese children. |
NCT00094302 | ALL | ADULT, OLDER_ADULT | Cardiovascular Diseases|Heart Diseases|Heart Failure, Congestive | DRUG: Spironolactone|DRUG: Placebo | Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First, Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject. | The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure hospitalization in patients who have heart failure with preserved systolic function. |
NCT00499603 | FEMALE | ADULT, OLDER_ADULT | Breast Cancer | DRUG: Paclitaxel|DRUG: 5-Fluorouracil|DRUG: Epirubicin|DRUG: Cyclophosphamide|DRUG: RAD001 | Number Participants With Inhibition of PI3K/PTEN/AKT Pathway at 48 Hours, Number of participants with inhibition of the PI3K/PTEN/AKT pathway at 48 hours after the start of treatment, regardless of the status of the pathway at the time of randomization. Molecular changes (inhibition/activation) of the PI3K/PTEN/AKT pathway evaluated using reverse phase protein arrays (RPPA) where fine-needle aspirations (FNAs) from the primary breast cancer obtained pretreatment, and at 48 hours. Bioinformatics cluster analysis of arrays used to define molecular changes as inhibition or activation where pathways called 'active' with presence of 2 or more phosphorilated pathway proteins (pAKT, pmTOR, pGSK3, pS6K1, pS6), and 'inhibited' with one or none phosphorilated pathway proteins present., 48 hours after start of treatment | The goal of this clinical research is to learn if RAD001 given in combination with chemotherapy will turn off the signaling pathway (a chain of information that tells cancer cells to grow quickly) and make the chemotherapies given on this study more effective.
Primary Objective
· To determine if the addition of an mTOR inhibitor to standard neoadjuvant chemotherapy in patients with triple receptor-negative breast cancer causes molecular changes (inhibition/activation) of the PI3K/PTEN/AKT pathway.
Secondary Objectives
* To evaluate pathologic complete response (pCR) rates for each treatment group.
* To evaluate the relationship between pCR and the molecular changes (inhibition/activation) of the PI13K/PTEN/AKT pathway in each treatment group.
* To evaluate overall response rates (ORR) for each treatment group.
* To assess the toxicity of both regimens and to evaluate the relationship of toxicities with PI3K/PTEN/AKT pathway status. |
NCT00994682 | ALL | ADULT, OLDER_ADULT | Nonalcoholic Steatohepatitis|Nonalcoholic Fatty Liver Disease|Type 2 Diabetes Mellitus | DRUG: Pioglitazone study drug|DRUG: Placebo|DRUG: Pioglitazone Open Label | Liver Histology (Using Kleiner et al Criteria, Hepatology 2005), Number of patients with reduction of at least 2 points in the nonalcoholic fatty liver disease activity score (NAS) (with reduction in at least 2 different histological categories) without worsening of fibrosis. NAS is the sum of the separate scores for steatosis (0-3), hepatocellular ballooning (0-2) and lobular inflammation (0-3), and ranges from 0-8 .
The scoring system is based on the following grading:
Steatosis: 0 = \<5%; 1 = 5-33%; 2 = \>33-66%; 3 = \>66%. Lobular Inflammation: 0 = No foci 1 = \<2 foci/200x; 2 = 2-4 foci/200x, 3 = \>4 foci/200x. Hepatocyte Ballooning: 0 = None; 1 = Few balloon cells; 2 = Many cells/prominent ballooning. Fibrosis: 0 = None; 1 = Perisinusoidal or periportal; 2 = Perisinusoidal and portal/periportal; 3 = Bridging fibrosis, 4 = Cirrhosis., At 18 months | Obesity and Type 2 diabetes are creating a silent epidemic, Non-alcoholic fatty liver disease, which is a chronic liver disease associated with insulin resistance, impaired glucose intolerance, and hepatic fat accumulation. The thiazolidinedione pioglitazone improves glucose/lipid metabolism and histology in NASH by improving insulin resistance in the liver/peripheral/adipose tissues and reducing subclinical inflammation. The aim of this study is to assess the underlying mechanisms at the clinical and molecular level and the long-term efficacy and safety of pioglitazone in NASH in a multiethnic cohort of subjects (predominantly Hispanics, Caucasians and African-Americans - the most common ethnic groups locally) and examine the response including patients with normal glucose tolerance, impaired glucose tolerance or established type 2 diabetes mellitus (T2DM). |
NCT01602861 | ALL | ADULT, OLDER_ADULT | Disorder Related to Renal Transplantation | DRUG: Spironolactone|DRUG: placebo | Change in Cr EDTA clearance, 0, 1 year, 2 years, 3 years | The purpose of this study is to assess whether the diuretic drug spironolactone can prevent chronic damage to transplanted kidneys caused by the medication that prevents rejection.
Spironolactone prevents the effects of the hormone aldosterone. Aldosterone is suspected of being involved in the processes leading to chronic rejection of transplanted kidneys. Hence, by blocking the effects of aldosterone we hope to be able to prevent loss of kidney function in transplant patients. |
NCT02905526 | FEMALE | CHILD, ADULT | Contraception | BEHAVIORAL: Contraceptive instant messages|OTHER: Mobile phone app | Use of effective contraception, The proportion reporting current use of effective contraception (pill, intrauterine device, injection, implant, patch), 4 months|Acceptability of at least one method of effective contraception, The proportion reporting that at least one method of effective contraception is acceptable (pill, intrauterine device, injection, implant, patch), 4 months | This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone app instant messaging on use of effective contraception in Bolivia. Woman aged 16-24 will be randomised to have access to Centro de Investigacion, Educacion y Servicios's sexual and reproductive health app (control) or the app plus 0-3 instant messages a day for 4 months (intervention). Participants will complete a questionnaire at baseline and 4 month follow-up. |
NCT04272047 | ALL | CHILD, ADULT, OLDER_ADULT | Athletic Injuries | OTHER: Knee Control+ program|OTHER: Adductor strengthening program|OTHER: Knee Control program | All physical complaints injury in four main locations, Any football related injury occurring to the ankle, knee, hamstrings and hip/groin, regardless of need of care or absence from football training or matches ("all physical complaints" injury definition), Study start up to end of season (7 months) | This is a three-armed intervention study that evaluates the injury preventive effects of three different training interventions in youth and adult football players. Two intervention arms are randomized and one arm acts as a non-randomized comparison group. Half of randomized participants will receive a general injury prevention exercise program with emphasis on the lower extremities, and the other half a hip/groin focused injury prevention exercise. A third group of participants who already use an injury prevention exercise program at study inclusion are invited to participate as a non-randomized comparison group and continue their usual training practices. |
NCT01593995 | ALL | ADULT, OLDER_ADULT | Non-small Cell Lung Cancer|Pancreatic Cancer | DRUG: Epidermal growth factor (EGF) ointment | Improvement of skin lesion grading by NCI-CTC v3.0, 4 weeks | Epidermal growth factor receptor-tyrosin kinase inhibitor (EGFR-TKI, Erlotinib) has demonstrated its efficacy in patients with non-small cell lung cancer and pancreatic cancer. But, their use is associated with dermatologic reactions of varying severity. Incidence of Erlotinib related skin effect (ERSE) was reported \~75% in NSCLC and pancreatic cancer phase III trials. Even though the dermatologic reactions could be a surrogated marker, it may be cause of dose modification. Also, it could give significant physical and psycho-social discomfort to patients. However, there is still a wide variety of drugs used- including, steroid, antibiotics, and vitamin D without any clear evidence based management recommendation.
The role of epidermal growth factor (EGF) has been extensively investigated in normal and pathological wound healing. It is implicated in keratinocyte migration, fibroblast function and the formation of granulation tissue. The first growth factor to be isolated growth factor therapy has progressed into clinical practice in the treatment of wounds.
Therefore, the investigators propose an epidermal growth factor ointment apply for patients with Erlotinib related skin effects. |
NCT01257022 | ALL | CHILD | Substance Use|Unsafe Sexual Behavior | BEHAVIORAL: Familias Unidas | Substance use, Substance use as measured by items similar to those in the Monitoring the Future Survey., 1 year|Unsafe sexual behavior, Unsafe sexual beahvior including unprotected sexual behavior and having sex while under the influence of alcohol or drugs., 1 year | The main goal of the proposed study is to evaluate the efficacy of Familias Unidas (United Families), a family-based, ecodevelopmental intervention found to be previously efficacious in preventing and reducing behavior problems, illicit drug use, and unsafe sexual behavior in non-delinquent Hispanic adolescents (Pantin et al., 2003; Prado, Pantin, Briones et al., 2007).
The study hypotheses are as follows:
Hypothesis 1. Familias Unidas will be more efficacious than Treatment as Usual in preventing drug use among Hispanic first offending adolescents or those who are at risk for committing a first time offense over time.
Hypothesis 1a. The effect of Familias Unidas on drug use will be partially mediated by improvements in family functioning.
Hypothesis 2. Familias Unidas will be more efficacious than Treatment as Usual in preventing unsafe sexual behavior among Hispanic first offending adolescents or those who are at risk for committing a first time offense over time.
Hypothesis 2a. The effect of Familias Unidas on unsafe sexual behavior will be partially mediated by improvements in family functioning.
Hypothesis 3. Familias Unidas will be more efficacious than Treatment as Usual in preventing subsequent criminal offenses among Hispanic first offending adolescents or in preventing a first time offense for those at risk for committing a first time offense over time.
Hypothesis 3a. The effect of Familias Unidas on subsequent criminal offenses will be mediated by family functioning. |
NCT01238211 | ALL | ADULT, OLDER_ADULT | Acute Myeloid Leukemia|Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome|Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11|Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11|Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1|Core Binding Factor Acute Myeloid Leukemia|Secondary Acute Myeloid Leukemia|Therapy-Related Acute Myeloid Leukemia | DRUG: Cytarabine|DRUG: Dasatinib|DRUG: Daunorubicin Hydrochloride|OTHER: Laboratory Biomarker Analysis | 30 Day Survival Rate, Percentage of participants who were alive 30 days after starting induction treatment., 30 days | This phase II trial studies the side effects and how well giving combination chemotherapy together with dasatinib works in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with dasatinib may kill more cancer cells. |
NCT00700427 | ALL | ADULT | Attention Deficit Hyperactivity Disorder | DRUG: atomoxetine hydrochloride|DRUG: Placebo | Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period, Conners' Adult ADHD Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV); 30-item scale (3 subscales): inattention, hyperactivity/impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (not at all/never) to 3 (very much/very frequently). Total ADHD symptoms score (SS)=inattention+hyperactivity/impulsivity (range:0-54). Higher score=more impairment. Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Maintenance of response during the randomized withdrawal phase was a reduction of ≥30% in the baseline CAARS-Inv:SV Total ADHD SS and a CGI-ADHD-S score ≤3. Participants had to continuously meet the response criteria, except for 1 excursion after assessment at Week 24 through Week 37 and 1 other excursion after assessment at Week 37 through Week 49. Excursions were not permitted at 2 consecutive visits., Baseline (Week 24) up to Week 49 | LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study. Those patients that meet the response criteria will continue the blind phase of the study up to a year. During that period, patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients nor investigators know if patients receive atomoxetine or placebo). |
NCT00565409 | ALL | ADULT, OLDER_ADULT | Arthritis, Rheumatoid | DRUG: Etanercept|DRUG: Methotrexate|DRUG: Etanercept|DRUG: Methotrexate|DRUG: Placebo|DRUG: Methotrexate | Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88, DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joint count (less than \[\<\]20 percent \[%\] missing SJC or PJC was prorated), erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and Patient's General Health Visual Analog Scale (VAS). VAS is a line 0-100 millimeters (mm) in length; ranged from 0 (very well)-100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units equals (=) low disease activity., Week 88 | To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks. |
NCT00500071 | ALL | CHILD | Attention Deficit Hyperactivity Disorder (ADHD) | DRUG: Vyvanse (lisdexamfetamine dimesylate) | Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks, Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54., Baseline and 7 weeks | Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect. |
NCT00407420 | ALL | CHILD, ADULT | Childhood Obesity | DEVICE: Mandometer|BEHAVIORAL: Lifestyle | BMI SDS or Z-score, Body Mass Index standard deviation (s.d.) scores also called Z-scores, are measures of relative weight adjusted for a child's age and sex. In terms of this score for weight management, a lower score would be viewed a beneficial outcome at the end of the intervention. The change in BMI SDS was calculated as the value at 12 months minus value at baseline ( a negative score being beneficial)., 12 months primary/ 18 months secondary outcome | We run a successful clinic in Bristol for children with severe obesity who already demonstrate many features to suggest they are at increased risk of early diabetes and heart disease. However, we have found that young children respond better to simple interventions than do adolescents. We have used a new treatment regimen "Mandometer®" to help our most difficult adolescent cases lose weight. We would like to do a study to see if all adolescents might improve weight loss using this technology compared to what we routinely offer |
NCT02134951 | ALL | ADULT | Healthy Controls | DRUG: Ketamine|DRUG: Normal saline | Glutamate + Glutamine (Glx) Response, Compare changes in Glx response to infusion of ketamine vs placebo, as measured by proton magnetic resonance spectroscopy (¹H MRS). Calculated by post-pre changes in the Glx over creatinine ratios, with higher values indicating higher Glx/creatinine ratios., Day 1 | The purpose of this study is to assess the relative feasibility of 2 potential functional measures of target engagement (Glx MRS, BOLD fMRI) to systematically assess mGluR 2/3 in drug development for psychotic spectrum disorders. |
NCT02973542 | ALL | ADULT, OLDER_ADULT | Irritable Bowel Syndrome | DRUG: Ethosuximide|OTHER: Placebo | 30% reduction in abdominal pain, through study completion, an average of 12 weeks.|Score of 4 or 5 on the SGA scale, through study completion, an average of 12 weeks. | Abdominal pain remains the most deleterious symptom for patients with irritable bowel syndrome (IBS) and is causing a significant alteration of their quality of life. The visceral hypersensitivity seems to be one of the key mechanisms that could explain the abdominal pain in these patients. Current treatments, mainly symptomatic, are of limited effectiveness, especially in terms of relief of abdominal pain. The study will aim to evaluate the effectiveness of ethosuximide on abdominal pain in patients with IBS, its tolerance and its impact on patient quality of life, severity of symptoms related to IBS and the use of analgesics / antispasmodic / regulators transit. |
NCT01631123 | ALL | ADULT, OLDER_ADULT | Metabolic Response to Dietary Modification | OTHER: Isocaloric high carbohydrate diet intervention|OTHER: Isocaloric high fat diet intervention | Genetic variance of change in insulin secretion and sensitivity after sequential diets, change in insulin secretion and sensitivity measured with an intravenous glucose tolerance test (IVGTT), 6,7,12 weeks | This is an intervention study in healthy adult twins with the aim to investigate the genetic determination of metabolic responses towards an isocaloric high carbohydrate, low fat diet versus an isocaloric low carbohydrate, high fat diet. |
NCT01039337 | ALL | ADULT, OLDER_ADULT | Osteoarthritis, Hip | OTHER: Hip School|OTHER: Hip School and Manual Treatment|OTHER: Minimal control intervention | Pain: Numerical pain scale, Baseline, 6 weeks, 3 months, 1 year | The purpose of the study is to evaluate the effect of manual treatment and a patient education programme for patients without indication for hip surgery. |
NCT05637125 | MALE | ADULT, OLDER_ADULT | Effect of Different Types of Aerobic Training on Diastolic Heart Failure Patients | OTHER: aerobic exercise for upper limb|OTHER: aerobic exercise for lower limb | Ejection fraction, Vivid S5 cardiovascular ultrasound system (BT308), made in china, was used to measure ejection fraction., 12 weeks|peak VO2, Oxycon pro (ER900, Germany) cardiopulmonary exercise test unit was used to measure Peak Vo2, 12 weeks | Background: Heart failure is described by a lack of confirmed efficient therapies and exercise intolerance. Physical activity is related to a lower risk of adverse cardiovascular consequences, involving heart failure. The purpose of the study: determine the effect of different types of aerobic training on peak VO2 and ejection fraction in diastolic heart failure patients. Subject and methods: Forty eligible male patients with diastolic heart failure, aged between 50 - 60 years old, participated in this study. They were selected from an outpatient clinic of general Zagazig hospital and were assigned into 2 equal groups in numbers. The first group (A) received aerobic exercise for the upper limb in form of arm ergometer exercises, while the second group (B) received aerobic exercise for the lower limb in form of cycling. Training duration for both groups was 3 sessions/week for 12 weeks. Peak VO2, and ejection fraction of both groups were measured and compared pre and post-treatment. Results: There was no significant difference in the ejection fraction between groups post-treatment. There was a significant increase in the peak VO2 of group B compared with that of group A post-treatment. Conclusion: there is no effect of different types of aerobic training on ejection fraction and peak VO2 for diastolic heart failure patients, but lower limb exercise is more effective than upper limb exercise in improvement of peak VO2 for diastolic heart failure patients. |
NCT00421551 | ALL | ADULT, OLDER_ADULT | HIV Infections | DRUG: Darunavir|DRUG: ritonavir | Proportion of patients with virological success, the virological failure is defined as 2 consecutive plasma viral load measurements greater or equal to 400 cp/ml within 2 weeks at W48, W48 | The purpose of this study is to evaluate whether a monotherapy of boosted darunavir is able to maintain the virological success until 48 weeks in comparison to a standard therapy 2 INTI + darunavir/r in HIV infected patients with full viral suppression. |
NCT03739060 | MALE | ADULT, OLDER_ADULT | Inguinal Hernia|Postoperative Pain|Quality of Life|Transcutaneous Electric Nerve Stimulation | DEVICE: Transcutaneous electric nerve stimulation | Change in pain level as assessed by the VAS., Pain is assessed using a 100 mm handheld slide rule-type visual analogue scale (VAS) with values from 0 to 100 (0 = no pain, 100 = extreme pain) during lying, waking and getting out of bed. Total scores are averaged., 10 min before and 10 min after each TENS procedure, which occur 24, 26, 48 and 50 hours after surgery. | Lichtenstein herniorrhaphy still remains one of the most often performed inguinal hernia repair techniques. It is frequently associated with acute postoperative and chronic pain. Due to insufficient effect of non-steroidal anti-inflammatory drugs, they are often overdosed. However opioids have many side effects. Interventional treatment, such as transversus abdominis plain (TAP) block requires an additional intervention and has relatively short effect, also could not be applied in outpatient conditions. The hypoalgesic effect of transcutaneous electric nerve stimulation (TENS) is well known for many years, but effectiveness during postoperative period is still controversial and maybe therefore didn't come to daily practice. However it could be a promising part of multi-modal pain treatment for hernia patients. This study analyse the hypoalgesic effect of TENS and its impact on hernia specific quality of life (QoL) after Lichtenstein hernia repair.
Aim#1 To determine whether use of TENS is effective for acute postoperative pain relief.
Aim#2 To determine whether use of TENS have impact on hernia specific QoL in early and late postoperative period.
Aim#3 To identify factors associated with effectiveness/ineffectiveness of TENS procedures.
Aim#4 To determine whether a psychological condition (depression, anxiety and pain catastrophisation) is somehow associated with TENS effectiveness. |
NCT01689077 | ALL | ADULT, OLDER_ADULT | Out of Hospital Cardiac Arrest | OTHER: Therapeutic hypothermia | CPC, CPC = Cerebral Performance Category Score. The primary outcome of the study is analyzed as the proportion of patients with good neurological outcome in the two groups, (CPC 1-2) at 6 months after CA., 6 month | The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours therapeutic hypothermia. |
NCT04329611 | ALL | ADULT, OLDER_ADULT | COVID-19 | DRUG: Hydroxychloroquine | Composite of hospitalization, invasive mechanical ventilation or death within 30 days, The aim of this intervention is to prevent severe COVID-19 disease.
This trial aims to confirm that severe COVID-19 disease can be reduced by a relative risk reduction of 50% by the use of hydroxychloroquine.The aim of this intervention is to prevent severe COVID-19 disease.
This trial aims to confirm that severe COVID-19 disease can be reduced by a relative risk reduction of 50% by the use of hydroxychloroquine.The aim of this intervention is to prevent severe COVID-19 disease.
This trial aims to confirm that severe COVID-19 disease can be reduced by a relative risk reduction of 50% by the use of hydroxychloroquine., Within 30 days of randomization | Albertans with COVID-19 are at risk of deteriorating and developing severe illness. Those over age 40 or with co-morbid illness, and likely those who are immune suppressed, are at highest risk. This study will include a focus on people with immune-suppressed states. Individuals confirmed to have SARS-CoV-2 infection will be identified using administrative data (positive lab result, age 18 or over, not hospitalized, and not living in SL4 level of care). They will then be contacted by AHS staff, independent of the researchers, to obtain their consent for the researchers to contact them about this trial. The AHS staff member who contacts the individual will enroll consenting individuals into a study database. If they provided an email address an email will automatically be sent to the individual with study information. Those who decline to be contacted will also be informed of the study website so they can choose to review the study information and self-enrol, although they will need to do so quickly to meet study timelines. Enrolled participants will be contacted by a study coordinator. Those without access to the internet will be informed about the study details when they are contacted by a study coordinator. When the study coordinator contacts potential participants the study will be reviewed, and the potential participant will have an opportunity to ask questions. Consent for participation will be obtained by telephone. Telephone consent will be recorded. Participants will then be screened for inclusion and exclusion criteria by telephone interview and review of Alberta Netcare. Alberta Netcare is the province of Alberta's public Electronic Health Record used to store patient information so that it is easily accessible to healthcare professionals for the purpose of care. Information like immunizations, ECG results, diagnostic images and reports, written medical reports (e.g. surgery reports, consultations, hospital admissions), diagnostic lab testing results (e.g. blood tests, urine tests, blood bank info), allergies and intolerances (drug and food allergies, food intolerances), prescription history, and general patient information (e.g. name, birthdate, personal health number, address, phone number). Those who are not eligible for the study will be informed of the reason(s) for ineligibility (generally it will be a safety exclusion and they should be aware of this). Those who are eligible will be randomized to receive HCQ or placebo for a total duration of 5 days. Study drug will be delivered to their residence by courier. Telephone follow-up will occur at day 7 (range 7-10 days) and at day 30 (range 25-35 days). |
NCT03893851 | ALL | CHILD, ADULT, OLDER_ADULT | Violence by Teachers | BEHAVIORAL: Interactions Competencies with Children - for Teachers (ICC-T) | Change of teachers' use of emotional and physical violence, - The Conflict Tactics Scale (CTS) will be used to assess teachers' use of emotional and physical violent discipline measures against students. Higher scores indicate higher levels of violence that is used by teachers. We hypothesize a stronger change of the use of violence in the intervention group compared to the control group., - The CTS will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention).|Change of student's exposure to emotional and physical violence by teachers, - The Conflict Tactics Scale (CTS) will assess the students' self-reported experiences of emotional and physical violence by teachers at school. Higher scores indicate higher levels of violence that is used by teachers. We hypothesize a stronger change of exposure to violence in the intervention group compared to the control group., - The CTS will be used at T1 (baseline, prior to intervention) and T2 (follow-up, 3 months after intervention | Brief Summary:
Violence against children is regarded as a key contributor to poverty and damages lifetime prospects for children in disadvantaged communities. However, physical violence is legally accepted as a disciplinary measure in schools in 68 states worldwide. For example, in Tanzania, corporal punishment is still lawful at school. It is thus not surprising that recently very high rates of violence (\~90%) were found at secondary schools. For children of primary school age, no such information is available from representative samples to date.
Moreover, in recent studies teachers often report having to resort to violent disciplinary methods referring to a lack of nonviolent disciplinary alternatives . However, only few interventions that aim at equipping teachers with non-violent action alternatives in Sub-Saharan Africa have been implemented, and even fewer have been scientifically evaluated.
Thus, in this study the investigators will implement and assess the efficacy of an intervention aimed at reducing the use of harsh and violent disciplinary measures in schools. Interaction Competencies with Children - for Teacher (ICC-T) aims to enable teachers to use non-violent disciplinary measures and to strengthen their competencies in non-violent interactions. Previously its feasibility and efficacy were proven in secondary schools in Tanzania. The present study aims to adapt ICC-T to, and evaluate its efficacy on, primary school level. The training is expected to improve the teacher-student relationships, change teacher's attitudes towards corporal punishment and their use of violent disciplinary measures. |
NCT00337636 | ALL | CHILD | Neuronal Ceroid Lipofuscinosis | PROCEDURE: Surgery to implant human CNS stem cells (HuCNS-SC)|DRUG: Medication to suppress the immune system | Safety, one year post transpant | Patients with infantile or late infantile NCL have either a reduced amount of, or are missing, the palmitoyl protein thioesterase 1 (PPT1) enzyme or the tripeptidyl peptidase 1 (TPP-I) enzyme. Human central nervous system stem cells (HuCNS-SC) are an investigational product derived from human brain cells. HuCNS-SC have been shown to survive and migrate within the brains of mice. When grown in the laboratory, HuCNS-SC have been shown to produce the PPT1 and TPP-I enzymes. In mice missing the PPT1 enzyme, HuCNS-SC have been shown to increase the amount of this enzyme in the brain, to reduce the amount of abnormal storage material in the brain, and to prevent the death of some neurons (a type of cell) in the brain.
Participation in this study will involve screening assessments, surgery to implant HuCNS-SC, medication to suppress the immune system, and a series of follow-up assessments. The length of time from the start of screening through to the last follow-up visit will be approximately 13 months, with frequent visits to the study center during this time. After completion of this study, patients will be monitored for an additional 4 years under a separate long term follow-up protocol. |
NCT02771249 | ALL | ADULT, OLDER_ADULT | HIV Infected Population With Latent Tuberculosis | DRUG: rifapentene (RPT)|DRUG: darunavir/cobicistat (DRV/c)|DRUG: Isoniazid (INH)|DIETARY_SUPPLEMENT: Pyridoxine | Area-under-the-curve during the dosing interval of 0 to t (AUC0-t), maximum total plasma concentration (Cmax), time to maximum plasma concentration (t-max), terminal halflife (t1/2), apparent oral clearance (CL/F), To assess the effects of once weekly administration of RPT and INH given at doses used for treating LTBI on the steady state PK of DRV/c, Days 4 14, and 19 | People with human immunodeficiency virus (HIV) often take several medicines to control HIV. Dolutegravir and darunavir boosted with cobicistat are HIV medicines that people may take. They may also need to take medicines for an infection called latent tuberculosis (TB). Researchers think a once-weekly treatment for latent TB would be easier for people with HIV to take. This once weekly treatment consists of two drugs: rifapentine and isoniazid. However, they need to see how TB drugs and HIV drugs interact.
Objective:
To learn how anti-HIV and anti-TB drugs affect each other so that people taking these drugs together can be treated safely.
Eligibility:
Healthy adults ages 18 65.
Design:
Participants will be screened with a medical history and physical exam. They will have vital signs taken and give a blood sample. Women will have a pregnancy test.
Participants cannot take any other medicines during the study, including vitamins. Only occasional, infrequent use of acetaminophen (Tylenol , max 2000 mg/day), ibuprofen (Motrin or Advil ), naproxen (Aleve ), loperamide (Imodium ), and/or antihistamines (such as Benadryl , Zyrtec , Claritin , etc.) will be allowed.
Participants will be assigned to one of three groups. Each group will take a different study drug, once or twice a day, for 19 23 days. At the baseline study visit, they will get a supply of the study drug tablets and instructions for taking them. Participants will keep a medicine diary to serve as a memory aid for taking medicine and reporting any side effects that they may experience.
Participants will have 8 or 9 study visits over about 40 days. The number of visits depends on which group the person is assigned to. All visits will take place at the NIH Clinical Center. Participants will fast before study visits.
The baseline visit will last about 2 3 hours. There will be 3-4 long visits that will last for about 12 hours. The other 4-5 visits will last about 1 hour.
During all study visits, screening procedures will be repeated. During long visits, an intravenous (IV) line will be inserted into an arm vein with a needle. It will be used to take blood. |
NCT02304302 | ALL | CHILD, ADULT | Down Syndrome|Intellectual Disability | DRUG: Memantine|DRUG: Placebo | Efficacy of the Drug Memantine as Assessed by Change in Score on the California Verbal Learning Test-II (CVLT-II) Short Form Total Free Recall, The primary efficacy measure is focused on episodic memory. The CVLT-II short form assesses supraspan word learning ability as an index of episodic verbal long-term memory. We hypothesize that treatment with memantine will produce significant improvements in this test. The main dependent variable selected, based on prior literature was the total number of target items correct summed across learning trials 1-4. The values for this measure have been recorded as change in score from baseline (T1) to after the treatment (T2). Scale Range: from 0 to 36; higher scores represent better outcomes., baseline and 16 weeks from start of treatment | The purpose of this research study is to learn if the medication Memantine Hydrochloride (the study medication) can help adolescents and young adults with Down syndrome. Dr. Alberto Costa and his research team want to see if a 16-week treatment with this medication can improve the participant's ability to learn and remember things. In this study, memantine hydrochloride will be used. Thus, the researchers want to learn whether the study drug can help improve memory in young adults with Down syndrome. To test the effect of the study medicine, half of the people in the study will receive the study medicine and half will receive a placebo (an inactive substance). Memantine is an approved medication to treat memory and thinking problems in persons with Alzheimer disease. However, little is known about the effect of this medication in persons with Down syndrome and it has not been approved for use in persons with Down syndrome. |
NCT00621764 | ALL | CHILD | Japanese Encephalitis|Hepatitis A | BIOLOGICAL: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)|BIOLOGICAL: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)|BIOLOGICAL: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)|BIOLOGICAL: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28) | Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection, 12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, \>39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, \>3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable.
2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, \>39˚C; Headache, Malaise, and Myalgia, Prevents activities., Day 0 up to Day 14 post-vaccination|Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection, 12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, \>39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, \>3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable.
2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, \>39˚C; Headache, Malaise, and Myalgia, Prevents activities., Day 0 up to Day 14 post-vaccination | Safety:
To describe the safety profiles following vaccination.
Immunogenicity:
To describe the immune response after a single dose of vaccine. |
NCT02204943 | MALE | ADULT, OLDER_ADULT | Bone Metastatic Castration-Resistant Prostate Cancer | DEVICE: Biomarker analysis|DRUG: Administration of radium-223 | Proportion of patients who overexpress alkaline phosphatase (ALP) in Circulating Tumor Cells (CTCs) at each time point, The proportion of patients who over-express ALP in the CTCs, defined as any over-expression, will be estimated using descriptive statistics at each time point. ALP expression will be concurrently examined in the bone metastatic biopsies of men as well, if evaluable tissue is available., Cycle 1 Day 1, Cycle 3 Day 1 and Cycle 6 Day 1 or disease progression | This study will examine biomarkers involved in osteomimicry in bone metastases and circulating tumor cells (CTCs) of men with mCRPC before and during therapy with the bone-targeting radiopharmaceutical radium-223. This study will also examine the bio-distribution of radium-223 in bone and bone metastases of men with mCRPC.
The investigators hypothesize that bone metastases and CTCs in men with mCRPC will commonly express markers of EMT/plasticity and osteomimicry, not just in the normal surrounding osteoblastic stroma but in the epithelial tumor cells themselves and that radium-223 will target both of these compartments including the more mesenchymal/osteoblastic tumor cells and the surrounding osteoblasts in the active bone microenvironment, with a relative sparing of normal bone and bone marrow. |
NCT04806477 | ALL | ADULT, OLDER_ADULT | Respiratory Tract Infections | OTHER: Telemedicine Consultation|OTHER: Face-to-face Consultation | Number of final evaluation ICD 10-code diagnosis., All institutional Emergency Department or Telemedicine assessments involve filling out the final diagnosis on an International Classification of Diseases (ICD-10)-code basis in the electronic medical record before discharge to home or admission. For aggregation of most prevalent RTI with similar pathophysiologic characteristics, three diagnostic groups were defined, based on ICD 10 codes: RTI, including COVID-19 (B34.2, B34.9, B97.2, J00, J04, J06, J11, J20, J30, J39, U07.1); PT - Acute Pharyngotonsillitis (J02-J03.9) and AS - Acute Sinusitis (J01-J01.9)., up to 10 months | This is a randomized study that sought to analyze the diagnostic accuracy of the telemedicine consultation of patients suspected of respiratory tract infections during COVID-19 pandemic in comparison with the face-to-face evaluation at the emergency department. |
NCT01175681 | ALL | CHILD, ADULT, OLDER_ADULT | Heart Valve Diseases | PROCEDURE: remote ischaemic preconditioning | plasma troponin I level, The investigators will measure the plasma troponin I level in several time points before and after surgery in each patient., with 7 days after surgery | Remote ischaemic preconditioning has shown its cardiac protective effect during heart surgery including coronary artery bypass graft surgery, congenital heart disease and aneurysm. However, no data was reported on heart valve disease surgery. Rheumatic heart disease is one of the major heart diseases requiring surgery in China. Thus, the investigators chose heart valve disease as a focus to see whether remote ischaemic preconditioning also has cardiac protective effect during heart valve surgery. |
NCT00071214 | ALL | ADULT, OLDER_ADULT | Staphylococcal Infections|Kidney Failure, Chronic | BIOLOGICAL: S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine | Documented S. aureus invasive infection, weeks 3-35 | Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic hemodialysis patients against infection by Staphylococcus aureus. |
NCT03682276 | ALL | ADULT, OLDER_ADULT | Hepatocellular Carcinoma | BIOLOGICAL: Ipilimumab|BIOLOGICAL: Nivolumab | Delay to surgery, Number of patients with an unplanned delay to surgery to Day 89 or later, Up to Day 89|Incidence of treatment-emergent adverse events [Safety and Tolerability], Safety and tolerability of the nivolumab and ipilimumab combination based on NCI CTCAE v5.0 criteria from the day of first nivolumab and ipilimumab administration to 126 days later, Up to Day 127 | The PRIME-HCC trial will assess the effects of combination treatment with nivolumab (OPDIVO) and ipilimumab (YERVOY) pre-operatively in hepatocellular carcinoma patients for whom liver resection is planned. The trial will be conducted at a small number of National Health Service hospitals in the UK. Participants will receive two doses of nivolumab and a single dose of ipilimumab in the weeks before their planned surgery. |
NCT02320253 | ALL | ADULT, OLDER_ADULT | Type 2 Diabetes Mellitus|Obesity | BEHAVIORAL: In Person Group (IP)|BEHAVIORAL: Telephone Conference Call Group (TCC)|BEHAVIORAL: Medical Nutrition Therapy (MNT) | Percent Weight Change From Baseline, Percent weight change form baseline; negative values indicate weight loss., Baseline, 6, 12, 24, and 36 months. | The goal of this project is to translate the Look AHEAD intensive lifestyle intervention for type 2 diabetes and obesity into usual care at community health centers, comparing an in-person group program (IP), a telephone conference call (TCC) group program, and referral to medical nutrition therapy (MNT), the current standard of care. |
NCT01171807 | ALL | ADULT, OLDER_ADULT | Ulcerative Colitis | DRUG: Dexamethasone 21-phosphate | The proportion of patients able to discontinue oral corticosteroids while maintaining clinical remission or stable condition, Patients in clinical remission or mild activity on oral corticosteroids will be treated with 6 monthly infusion of Dexamethasone 21-phosphate loaded into autologous erythrocytes. During the treatment period, oral corticosteroids will be gradually discontinued., 6 months | The purpose of this study is to investigate the efficacy and safety of erythrocyte-mediated delivery of dexamethasone in steroid-dependent ulcerative colitis patients |
NCT04333238 | ALL | CHILD, ADULT, OLDER_ADULT | Clinical Documentation | OTHER: New progress note template|OTHER: Standard progress note template | Note length, Note length in line count., Duration of note entry, up to 2 hours|Time to note completion, Time to note completion in minutes., Duration of note entry, up to 2 hours|Note evaluation by authors using a likert scale, Likert-scale survey instrument evaluating perceived organization, structure, and efficiency of note., Immediately after note entry, up to 1 hour|Note evaluation by reviewers using the Physician Documentation Quality Instrument, Physician Documentation Quality Instrument (PDQI-9) - validated note quality scale composed of 9 metrics. 1 is not at all. 5 is extremely., Within 1 year | This is a randomized non-blinded controlled trial of a standard note template versus a redesigned note template using a simulated patient encounter and the electronic medical record. |
NCT00415597 | ALL | ADULT, OLDER_ADULT | Pain | DRUG: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) | Subjects With Treatment Emergent Adverse Events, Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product)., up to 12 months | Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months. |
NCT02384538 | ALL | ADULT, OLDER_ADULT | Erosive Hand Osteoarthritis | BIOLOGICAL: ABT-981|BIOLOGICAL: Placebo for ABT-981 | Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16, The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. Last Observation Carried Forward (LOCF): Missing responses were imputed by calculation based on the last nonmissing postbaseline component values., Week 0 (Baseline), Week 16 | This is a multicenter, randomized, double-blind, placebo-controlled study to compare the safety and efficacy of ABT-981 to placebo in subjects with erosive hand osteoarthritis. |
NCT00736086 | ALL | ADULT, OLDER_ADULT | Peripheral Vascular Disease|Cardiovascular Disease | DEVICE: Vessel Closure (StarClose™) | null | To evaluate early ambulation in patients who receive the StarClose™ VCS post-percutaneous diagnostic procedure. |
NCT03662945 | ALL | OLDER_ADULT | Frail Elderly Syndrome | OTHER: Mobile Geriatric Team intervention | Health care utilization including EMR, hospital admissions, care days, out patient hospital or primary care, No. of EMR visits, Out patient visits to hospital, Hospital admissions, Care days, Primary care visits, Change from 1 year before inclusion to 1 year follow up | Objective To perform a prospective, controlled and randomized evaluation of the effectiveness of Mobile Geriatric Teams (MGT).
Method Community-dwelling, frail elderly people were randomized to intervention group (n=31, mean age 84) and control group (n=31, mean age 86). Two-year retrospective data and prospective one-year follow up, were analyzed using non-parametric and difference-in-difference (DiD) analyses. Qualitative interviews, were analyzed using content analysis. |
NCT03566472 | ALL | CHILD, ADULT, OLDER_ADULT | Type2 Diabetes | DIAGNOSTIC_TEST: Continuous Glucose Monitoring System | HbA1c, Blood glycated hemoglobin, Day 1|MBG, 24 h mean blood glucose, Day 1 to Day 4|MAGE, 24 h mean amplitude of glycemic excursions, Day 1 to Day 4|SDBG, the standard deviation of the MBG, Day 1 to Day 4 | Glargine is commonly used in insulin supplemental therapy in patients with type 2 diabetes(T2D) at present. This study aims to investigate the current status of blood glucose control in patients with T2D treated with glargine. Glycated hemoglobin(HbA1c) will be tested in these patients to assess the blood glucose control and Continuous Glucose Monitoring System (CGMS) will be used to investigate the glucose variability. Islet function, duration of diabetes, complications, exercise, insulin dose, oral medication regimen and insulin antibodies will be recorded in detail. This study will analysis the association between these clinical characteristics and blood glucose control. |
NCT02831309 | ALL | CHILD | Childhood Obesity | BEHAVIORAL: Light-Intensity Condition|BEHAVIORAL: Moderate-Intensity Condition|BEHAVIORAL: High-Intensity Condition|BEHAVIORAL: Sedentary Condition | Physical activity energy expenditure, Physical activity energy expenditure throughout the condition day and over the next three days. Participants wore an accelerometer for four days. Energy expenditure was calculated from accelerometer data., 4 days | ACS examined the potential influence of intermittent physical activity breaks of various intensities (control, light, moderate, vigorous) on measures of immediate mental performance, mood, hunger and several metabolic outcomes in children aged 7-11 years. We build upon previous work to hypothesize that higher-intensity intermittent physical activity breaks throughout an 8-hour day will improve immediate mental performance, mood, and post-exercise physical activity levels, while reducing hunger and post-exercise food intake. |
NCT00767260 | ALL | ADULT, OLDER_ADULT | Type 2 Diabetes Mellitus | DRUG: BM-MNC+HOT|DRUG: BM-MNC|DEVICE: HOT|DRUG: SMT | area under the curve of c-peptide, 1 year | There were evidences that the non-immune mediated inflammatory pathways of cell damage occurred in vitro in human islets upon hyperglycemia in type 2 diabetes mellitus. Autologous stem cell therapies were an emerging set of therapies that showed promise with a low side effect profile. we hypothesized that infusion of mononuclear cells from buffy coat obtained from bone marrow might provide multiple signals for regeneration and inflammation-induced lesion recovery of local tissues, of which the effect might be maximized by intra-arterial pancreatic infusion through angiography and combination with hyperbaric oxygen therapy.
This trail includes a foregoing sub-trial that investigate the feasibility and safety of a novel method for massive bone marrow collection. The traditional BM collecting procedure is unfavorable because it yields minor bone marrow. Studies have shown that physiological exercise can increase bone marrow blood flow, which might facilitate BM collection.
We plan to include a total of 60 patients with type 2 diabetes and randomly assign them to either a control group or an exercise group (n =30 each). The patients in the exercise group exercised 30 minutes before the operation. All patients underwent routine surgical care. The collected BM volume, operation time, collecting speed , puncture times and pain scores during the operation were recorded. Bone marrow samples were tested for CD34+ flow cytometry and whole blood cell count. |
NCT00047385 | ALL | ADULT, OLDER_ADULT | Lung Cancer | DEVICE: low-dose helical computed tomography|DEVICE: chest radiography | Lung Cancer Deaths, Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate., All events through December 31, 2009; median follow-up 6.5 years. | RATIONALE: Effective screening tests should help doctors detect lung cancer early and plan curative treatment. It is not yet known whether low-dose helical computed tomography (LDCT) screening is more effective than chest radiography (CXR) screening in reducing death from lung cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of LDCT scan with that of CXR in screening individuals who are at high risk for developing lung cancer. |
NCT00079066 | ALL | CHILD, ADULT, OLDER_ADULT | Colorectal Cancer|Quality of Life | BIOLOGICAL: cetuximab|PROCEDURE: quality-of-life assessment | Overall survival | RATIONALE: Monoclonal antibodies, such as cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Best supportive care is the use of drugs and other treatments to improve the quality of life of patients. Combining cetuximab with best supportive care may slow the growth of the tumor and help patients live longer and more comfortably. It is not yet known whether cetuximab combined with best supportive care is more effective than best supportive care alone in treating metastatic epidermal growth factor receptor-positive colorectal cancer.
PURPOSE: This randomized phase III trial is studying cetuximab and best supportive care to see how well they work compared to best supportive care alone in treating patients with metastatic epidermal growth factor receptor-positive colorectal cancer. |
NCT00292877 | ALL | ADULT, OLDER_ADULT | Asthma | DRUG: SB-240563 (Mepolizumab) | The prednisone-sparing effect of SB-240563 versus placebo as|indicated by the absolute and percentage dose reduction possible without a clinical exacerbation (as measured by the Juniper ACQ in patients with asthma or by Likert symptom scores +/- FEV1 in patients with eosinophilic bronchitis without asthma). | The purpose of this study is to determine if treatment with anti-IL-5 antibody has a prednisone-sparing effect in patients with symptomatic eosinophilic bronchitis (with or without asthma). |
NCT04013295 | MALE | ADULT, OLDER_ADULT | HIV/AIDS | OTHER: Prize-linked savings | Increase in savings balance, This is a binary variable equal to 1 if the respondent's savings balance increased over the study period, and zero otherwise., Measured throughout follow-up period (approx 3 months)|Savings balance, Total increase in savings balance over the study period (continuous measure), Measured throughout follow-up period (approx 3 months)|Expenditures on alcohol, Total spending on alcohol in past 7 days, Recall period: past 7 days, measured in endline survey (approx 3 months after enrollment)|Participation in and expenditures on transactional sex, Total spending on transactional sex in past month, and binary indicator for any spending, Recall period: past month, measured in endline survey (approx 3 months after enrollment) | Transactional sex is widely believed to be among the driving factors for the high HIV rates among adolescent girls and young women in Kenya. We will pilot a randomized trial among men in Kenya to assess whether prize-linked savings opportunities reduce spending on transactional sex. The project will randomize men to the savings intervention and assess changes in key economic and self-reported health outcomes over a 3-6 month period. |
NCT02433457 | ALL | ADULT, OLDER_ADULT | Healthy Volunteers | DRUG: CC-292|DRUG: Oral Omeprazole (OMP) | Pharmacokinetics - Cmax, Maximum observed concentration in plasma, 48 hours|Pharmacokinetics - AUC 0-t, Area under the plasma concentration-time curve from time zero to the last measured time point, 48 hours|Pharmacokinetics - AUC 0-24, Area under the plasma concentration-time curve to 24 hours post dose, 48 hours|Pharmacokinetics - AUC 0-∞, Area under the plasma concentration-time curve from time zero extrapolated to infinity, 48 hours|Pharmacokinetics - %AUCextrap, Percent Area under the plasma concentration-time curve extrapolated, 48 hours|Pharmacokinetics - Frel, Relative bioavailability of the CC-292 SDD formulation compared to the reference P22 formulation, 48 hours|Pharmacokinetics - Tmax, Time to Cmax, 48 hours|Pharmacokinetics - λz, Terminal disposition rate constant, 48 hours|Pharmacokinetics - t1/2, Terminal half-life, 48 hours|Pharmacokinetics - CL/F, Apparent clearance, 48 hours|Pharmacokinetics - Vz/F, Apparent volume of distribution, 48 hours | To evaluate the PK profile of the newly developed CC-292 SDD formulation compared to CC-292 P22 tablet. |
NCT02136381 | ALL | ADULT, OLDER_ADULT | Health Behavior | BEHAVIORAL: LEAP intervention|BEHAVIORAL: Control | Feasibility and acceptability of intervention, Participants will complete a questionnaire directed to obtain early markers of how the intervention is used, 2 months | The LiveWell research programme aims to develop evidence-based, acceptable and scalable interventions to improve health and wellbeing in the retirement transition.
Life stage transitions involve changes in lifestyle and thus present key opportunities for behaviour change interventions. Our assessment of the literature shows that interventions with people of retirement age can effectively promote components of the Mediterranean diet (Lara et al, BMC Medicine Apr 8;12(1):60: 2014), physical activity (Hobbs et al, BMC Medicine Mar 19;11:75; 2013) and explicit social roles (Heaven et al, Milbank Q. Jun;91(2):222-87: 2013).
This study is a 2-month randomised controlled trial (RCT) with two intervention arms taking place in the North-East of England.
We have developed an internet-based lifestyle programme (Living, Eating, Activity and Planning through retirement (LEAP)) that promotes three key health and social behaviours; 1) healthy eating by adopting a Mediterranean diet, 2) increasing physical activity with the use of a step-counter, and 3) improving social connectedness.
Participants recruited for this study will be allocated in random order with a ratio of 2:1 to the intervention group (LEAP) or to a control group.
This study will evaluate the feasibility and acceptability of the LEAP intervention among people of retirement age and will pilot trial procedures.
In this programme of research we have also defined a suite of outcome measures and identified tools appropriate for capturing the Healthy Ageing Phenotype (HAP) (Lara et al, Maturitas. 2013 Oct;76(2):189-99). We will assess aspects of Cognition, Physical capability, Physiological outcomes, and psycho-social wellbeing. The feasibility and acceptability of these measures has yet to be determined and therefore will be formally assessed in this pilot RCT alongside more proximal outcomes of the intervention modules (i.e. diet, physical activity and social roles).
The hypotheses to be tested in the LiveWell programme are as follows:
* A newly developed internet-based lifestyle programme (Living, Eating, Activity and Planning through retirement (LEAP)) is an acceptable tool for behaviour change among people of peri-retirement age.
* A suite of outcome measures and identified tools appropriate for capturing the Healthy Ageing Phenotype (HAP) is acceptable among people of peri-retirement age. |
NCT01530360 | ALL | CHILD | Premature Infants|Near-infrared Spectroscopy|Oximetry | DEVICE: cerebral oximeter | change of medical management elicited by cerebral oxygenation out of range, Recording of the type of change of management as defined by the treatment guideline, 0-72 hours of life | Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of hyper- and hypoxia can be accomplished during the first three days of life in infants born before 28 completed weeks of gestation. The investigators developed a treatment guideline and a randomised trial design to evaluate if cerebral rStO2 spent out of range in %hours can be reduced by 50%. The present trial is a non-randomised pilot study of the intervention in 10 infants. |
NCT00725985 | ALL | ADULT | Multiple Sclerosis | DRUG: Cladribine|DRUG: Placebo|DRUG: Rebif® new formulation (RNF) | ITP: Time to Clinically Definite Multiple Sclerosis (CDMS) Conversion Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS, CDMS according to the Poser criteria is defined as the occurrence of a second attack or a sustained increase in the expanded disability status scale (EDSS) Score. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to Multiple Sclerosis \[MS\]) was calculated. Sustained EDSS progression was defined as an increase in the EDSS score of greater than or equal to (\>=) 1 point if baseline EDSS was between \>= 1.0 and less than or equal to (=\<) 4.5; or \>= 1.5 points if baseline EDSS was 0, or \>= 0.5 if baseline EDSS \>= 5.0 over a period of at least 3 months. Kaplan-Meier estimates were provided for of the cumulative (cum.) percentage (%) of participants with CDMS over time. The probability of patients remaining event-free over time (from randomization) in each of the three treatment groups was displayed in the form of survival curves estimated using the non-parametric Kaplan-Meier method., ITP: Baseline up to Week 96 | A randomized, double-blind, clinical trial to assess the safety and efficacy of two doses of oral cladribine versus placebo in participants who had a first clinical demyelinating event (clinically isolated syndrome). Participants in either the cladribine or placebo group may also enter treatment periods with open-label interferon-beta or open-label cladribine depending upon the disease status. The primary objective of this study is to evaluate the effect of two dosage regimens of oral cladribine versus placebo on the time to conversion to multiple sclerosis (MS) (from randomization) according to the Poser criteria in participants with first clinical demyelinating event at high risk of converting to MS. |
NCT00255606 | MALE | ADULT, OLDER_ADULT | Prostate Cancer | DRUG: docetaxel|DRUG: prednisone | Time to treatment failure (TTF) | RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which schedule of docetaxel and prednisone is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying two different schedules of docetaxel and prednisone to compare how well they work in treating patients with metastatic prostate cancer. |
NCT02312167 | ALL | ADULT, OLDER_ADULT | Cancer of Digestive System|Ovarian Cancer | DEVICE: confocal laser endomicroscopy | The number of participants with adverse events, their type and severity, 8 months | This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE).
Contraindications for resection surgery may sometimes be missed during exploratory surgical procedures. That may lead to an incomplete thus useless surgery and delay the right treatment.
The objectives of this study are to improve the detection of cancer extension during exploratory procedures and to guide resection to ensure clear margins. |
NCT01598298 | FEMALE | CHILD, ADULT, OLDER_ADULT | Breast Cancer|Musculoskeletal Complications|Pain | DRUG: duloxetine hydrochloride|OTHER: placebo | Average Joint Pain According to BPI-SF, Average joint pain according to the Brief Pain Inventory - Short Form (BPI-SF) average pain score (item #4). This item has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine"., Weeks 2, 6, 12, and 24; Week 12 reported | RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy.
PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy. |
NCT01535430 | ALL | ADULT, OLDER_ADULT | Primary Brain Tumor|Metastatic Brain Tumor | DIAGNOSTIC_TEST: Brain mapping | Eloquent function, The location of the eloquent function of interest (motor, sensory, speech) will be assessed pre-operatively and intra-operatively. These will be compared. Then, at 2 and 6 months post-operatively, repeat non-invasive mapping studies will be performed to compare to the subjects' prior studies. This will allow for assessment of reorganization and plasticity of function. Addtionally, novel ways of identifying eloquent brain regions will be developed., 1 year | Purpose of the study:
AIM 1 Prospectively collect pre-operative (fMRI, DTI, MEG) and intra-operative mapping data in patients with intra-axial brain tumors to assess how well each modality predicts the location of eloquent brain function. In addition, each modality will be compared with the other.
AIM 2 Assess reorganization of eloquent brain function and plasticity in patients with intra-axial brain tumors. This will be accomplished by prospectively collecting post-operative mapping studies and neuropsychological tests to compare them to prior mapping studies as stated above. |