HiTZ/Multilingual-Medical-Corpus · Datasets at Hugging Face

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8. Female patients of childbearing potential (not surgically sterile) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for the follow-up time period. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.

9. Male patients with partners of childbearing potential must agree to use adequate contraception (barrier method or abstinence) during the study, including the follow-up time period.

10. The patient must be willing and able to comply with study requirements, remain at the clinic, and be willing and able to return to the clinic for the follow-up evaluation as specified in this protocol during the study period.

Exclusion Criteria:

1. Patient has Grade B aGvHD with skin-only involvement.

2. Patient has received any second line therapy to treat aGVHD prior to screening.

3. Patient has received systemic agents other than steroids and prophylactic agents for primary treatment of acute GVHD.

4. Patient shows evidence of diffuse alveolar hemorrhage or other active pulmonary disease, which is likely to require more than 2L of oxygen via face mask or an estimated FiO(2) of 28% via other delivery methods in order to sustain an O(2) saturation of 92%.

5. Patient has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the subject including but not limited to uncontrolled infection, heart failure, pulmonary hypertension, etc.

6. Patient has received any stem cell agents (other than hematopoietic graft) during study participation or within 30 days prior to study entry.

7. Patient has a known allergy to bovine or porcine products.

8. Patient has received an HSCT transplant for a solid tumor disease.

9. Patient has had prior treatment with mesenchymal stem cells (MSCs), including remestemcel-L.

10. Patient shows evidence of severe hepatic veno-occlusive disease (VOD) or sinusoidal obstruction.

11. Patient shows evidence of encephalopathy as defined by a change in mental status since the onset of aGVHD.

12. Patient is a female who is pregnant, lactating, or is planning a pregnancy during study participation, or in the follow-up period.

13. Patient has had an active solid tumor malignancy within the last 5 years from screening, except for cervical carcinoma in situ localized prostate cancer or nonmelanoma skin cancer that has been definitively treated.

14. Patient has participated in any interventional clinical trial for an aGVHD therapeutic agent or for an immunomodulatory drug, within the past 30 days or within 5 half-lives of the investigational medicinal product (IMP), whichever is the greater.

15. Patient has participated or is currently participating in any bone marrow derived autologous and allogeneic stem cell or gene therapy study.

16. Patient has a known hypersensitivity to dimethyl sulfoxide (DMSO) or murine or bovine proteins.

CYSTATIN C AND UNCONTROLLED HYPERTENSION:
Hypertension is an underdiagnosed and undertreated disease in real-life. Blood pressure and kidney functions are known to be closely related. Increased serum level of Cystatin C, a sensitive biomarker for renal function, seems to predict adverse cardiovascular events. The investigators aimed to evaluate the predictive value of serum Cystatin C for control of hypertension in a community-based study.
Adults residing in both rural and urban communities
Inclusion Criteria:

- Individuals who accept to participate to the survey

- > 18 years

Exclusion Criteria:

- Individuals who are not able to complete the questionnaire

- Individuals who didn't give informed consent

SKIN PROTECTION DURING RADIOTHERAPY IN PATIENTS WITH BREAST CANCER:
Radiotherapy may cause severe skin changes that significantly interfere with the patient's quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and various topical agents are recommended to help patients in the management of radiation skin reactions, but evidence to support the value of the topical treatments of the irradiated skin is lacking. In the present study we investigated the effects of two topical agents used as supportive care to protect skin during radiotherapy.
Women with breast cancer and were to receive breast radiotherapy to 50 Gy were enrolled in a prospective randomized trial to compare the effectiveness of Evoskin®) for protecting skin compared to Trixiera. To account for individual differences in radiation each subject served as her own control, as each was to apply the experimental and control agents to the irradiated breast. Each patient was randomly assigned to use Evoskin on the half of the irradiated breast and to use the Triexiera on the other half. Dermatitis was graded weekly by means of a spectrophotometer.
Inclusion Criteria:

- 18 years old or more

- Patients with breast cancer for which a treatment by radiotherapy is planned

- No concomitant chemotherapy

- Signed informed consent

Exclusion Criteria:

- Cutaneous neoplasia radiotherapy

- Total mastectomy

- Bilateral breast cancer

- Dark skinDiseases enhancing radiosensitivity Patient with a generalized skin disorder

- Pregnant, breast-feeding woman

TEXT-MESSAGE-BASED DEPRESSION PREVENTION FOR HIGH-RISK YOUTH IN THE ED:
The purpose of this randomized controlled study is to evaluate acceptability and feasibility, and to gather preliminary data about efficacy, of "iDOVE," a brief emergency department introductory session + longitudinal automated text-message depression prevention program for high-risk teens.
Peer violence and depressive symptoms have mutual, reinforcing negative impacts on teens' emotional and behavioral regulation strategies.

The emergency department (ED) is the primary source of care for many high-risk teens. It provides an opportunity to initiate preventive interventions, to complement existing mental health treatment or to stand alone for those who may lack access to formal care. Personalized text-message interventions are accessible, feasible, and may be effective with these adolescents.

The purpose of this study is to test the feasibility and acceptability of a novel text-message augmented depression prevention intervention, "iDOVE." Drawing on effective cognitive behavioral therapy (CBT) and motivational interviewing (MI) depression and violence prevention interventions, a brief in-ED session will introduce basic cognitive and behavioral strategies. Following ED discharge, eight weeks of tailored CBT-informed daily text messages will be sent, to enhance skills and remind participants of self-determined goals.

Participants will be identified in the course of usual ED care. If eligible, parents will be consented and participants assented. Participants will complete a baseline assessment and will be randomized to experimental (ED+text, n=50) or enhanced usual care (EUC, n=50) care, using stratified block randomization.

ED+text group participants will participate in a brief, structured in-ED introduction on CBT and the iDOVE program, followed by 8 weeks of tailored, two-way, CBT-and MI-informed automated text messages (short message service, SMS). EUC group participants will participate in a brief, structured, in-ED introduction to home safety & nutrition, followed by 8 weeks of automated SMS regarding home safety & nutrition. The current standard of care for these patients is no care: no depression or violence screening assessment protocols are currently used in our ED. Both ED+text and EUC conditions therefore exceed current levels of care.

At baseline, 8 week follow-up, and 16 week follow-up, participants will complete assessments on depressive symptoms, violence, cognitive/behavioral skill-sets, and resource utilization. At the 8-week follow-up, standardized qualitative and quantitative process measures will be administered to assess efficacy, acceptability, usability, and feasibility.
Inclusion Criteria:

- English-speaking

- presenting to the emergency department for routine care

8. Female patients of childbearing potential (not surgically sterile) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for the follow-up time period. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.

9. Male patients with partners of childbearing potential must agree to use adequate contraception (barrier method or abstinence) during the study, including the follow-up time period.

10. The patient must be willing and able to comply with study requirements, remain at the clinic, and be willing and able to return to the clinic for the follow-up evaluation as specified in this protocol during the study period.

Exclusion Criteria:

1. Patient has Grade B aGvHD with skin-only involvement.

2. Patient has received any second line therapy to treat aGVHD prior to screening.

3. Patient has received systemic agents other than steroids and prophylactic agents for primary treatment of acute GVHD.

4. Patient shows evidence of diffuse alveolar hemorrhage or other active pulmonary disease, which is likely to require more than 2L of oxygen via face mask or an estimated FiO(2) of 28% via other delivery methods in order to sustain an O(2) saturation of 92%.

5. Patient has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the subject including but not limited to uncontrolled infection, heart failure, pulmonary hypertension, etc.

6. Patient has received any stem cell agents (other than hematopoietic graft) during study participation or within 30 days prior to study entry.

7. Patient has a known allergy to bovine or porcine products.

8. Patient has received an HSCT transplant for a solid tumor disease.

9. Patient has had prior treatment with mesenchymal stem cells (MSCs), including remestemcel-L.

10. Patient shows evidence of severe hepatic veno-occlusive disease (VOD) or sinusoidal obstruction.

11. Patient shows evidence of encephalopathy as defined by a change in mental status since the onset of aGVHD.

12. Patient is a female who is pregnant, lactating, or is planning a pregnancy during study participation, or in the follow-up period.

13. Patient has had an active solid tumor malignancy within the last 5 years from screening, except for cervical carcinoma in situ localized prostate cancer or nonmelanoma skin cancer that has been definitively treated.

14. Patient has participated in any interventional clinical trial for an aGVHD therapeutic agent or for an immunomodulatory drug, within the past 30 days or within 5 half-lives of the investigational medicinal product (IMP), whichever is the greater.

15. Patient has participated or is currently participating in any bone marrow derived autologous and allogeneic stem cell or gene therapy study.

16. Patient has a known hypersensitivity to dimethyl sulfoxide (DMSO) or murine or bovine proteins.

CYSTATIN C AND UNCONTROLLED HYPERTENSION:

Hypertension is an underdiagnosed and undertreated disease in real-life. Blood pressure and kidney functions are known to be closely related. Increased serum level of Cystatin C, a sensitive biomarker for renal function, seems to predict adverse cardiovascular events. The investigators aimed to evaluate the predictive value of serum Cystatin C for control of hypertension in a community-based study.

Adults residing in both rural and urban communities

Inclusion Criteria:

- Individuals who accept to participate to the survey

- > 18 years

Exclusion Criteria:

- Individuals who are not able to complete the questionnaire

- Individuals who didn't give informed consent

SKIN PROTECTION DURING RADIOTHERAPY IN PATIENTS WITH BREAST CANCER:

Radiotherapy may cause severe skin changes that significantly interfere with the patient's quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and various topical agents are recommended to help patients in the management of radiation skin reactions, but evidence to support the value of the topical treatments of the irradiated skin is lacking. In the present study we investigated the effects of two topical agents used as supportive care to protect skin during radiotherapy.

Women with breast cancer and were to receive breast radiotherapy to 50 Gy were enrolled in a prospective randomized trial to compare the effectiveness of Evoskin®) for protecting skin compared to Trixiera. To account for individual differences in radiation each subject served as her own control, as each was to apply the experimental and control agents to the irradiated breast. Each patient was randomly assigned to use Evoskin on the half of the irradiated breast and to use the Triexiera on the other half. Dermatitis was graded weekly by means of a spectrophotometer.

Inclusion Criteria:

- 18 years old or more

- Patients with breast cancer for which a treatment by radiotherapy is planned

- No concomitant chemotherapy

- Signed informed consent

Exclusion Criteria:

- Cutaneous neoplasia radiotherapy

- Total mastectomy

- Bilateral breast cancer

- Dark skinDiseases enhancing radiosensitivity Patient with a generalized skin disorder

- Pregnant, breast-feeding woman

TEXT-MESSAGE-BASED DEPRESSION PREVENTION FOR HIGH-RISK YOUTH IN THE ED:

The purpose of this randomized controlled study is to evaluate acceptability and feasibility, and to gather preliminary data about efficacy, of "iDOVE," a brief emergency department introductory session + longitudinal automated text-message depression prevention program for high-risk teens.

Peer violence and depressive symptoms have mutual, reinforcing negative impacts on teens' emotional and behavioral regulation strategies.

The emergency department (ED) is the primary source of care for many high-risk teens. It provides an opportunity to initiate preventive interventions, to complement existing mental health treatment or to stand alone for those who may lack access to formal care. Personalized text-message interventions are accessible, feasible, and may be effective with these adolescents.

The purpose of this study is to test the feasibility and acceptability of a novel text-message augmented depression prevention intervention, "iDOVE." Drawing on effective cognitive behavioral therapy (CBT) and motivational interviewing (MI) depression and violence prevention interventions, a brief in-ED session will introduce basic cognitive and behavioral strategies. Following ED discharge, eight weeks of tailored CBT-informed daily text messages will be sent, to enhance skills and remind participants of self-determined goals.

Participants will be identified in the course of usual ED care. If eligible, parents will be consented and participants assented. Participants will complete a baseline assessment and will be randomized to experimental (ED+text, n=50) or enhanced usual care (EUC, n=50) care, using stratified block randomization.

ED+text group participants will participate in a brief, structured in-ED introduction on CBT and the iDOVE program, followed by 8 weeks of tailored, two-way, CBT-and MI-informed automated text messages (short message service, SMS). EUC group participants will participate in a brief, structured, in-ED introduction to home safety & nutrition, followed by 8 weeks of automated SMS regarding home safety & nutrition. The current standard of care for these patients is no care: no depression or violence screening assessment protocols are currently used in our ED. Both ED+text and EUC conditions therefore exceed current levels of care.

At baseline, 8 week follow-up, and 16 week follow-up, participants will complete assessments on depressive symptoms, violence, cognitive/behavioral skill-sets, and resource utilization. At the 8-week follow-up, standardized qualitative and quantitative process measures will be administered to assess efficacy, acceptability, usability, and feasibility.

Inclusion Criteria:

- English-speaking

- presenting to the emergency department for routine care