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

text stringlengths 0 19.9k

- The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures

- The subject is either male or female and aged ≥ 20 to < 75 years at the time of consent

- The subject is an early-stage nephropathy (Stage 2) patient with type 2 diabetes mellitus

- The subject is a patient with type 2 diabetes mellitus on a certain diet therapy and/or exercise therapy (if any)

- The subject's blood glucose, blood pressure and lipid are stably controlled, and drug changes or dose changes of therapeutic drugs for hypertension, therapeutic drugs for diabetes mellitus, therapeutic drugs for dyslipidemia or hyperlipidemia are not required throughout the study period as judged by the investigator

- A male subject who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose

- A female subject of childbearing potential who is sexually active with a nonsterilized male partner who agrees to routinely use adequate contraception from signing of informed consent until 1 month after the completion of the study

Exclusion Criteria:

- The subject has received TAK-272 in a previous clinical study

- The subject is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may have given consent to participate under duress

- The subject has a history of hypersensitivity or allergies to TAK-272, candesartan cilexetil and other RAS inhibitors (ACE inhibitors, ARBs or DRIs)

- The subject needs to take the prohibited medications during the study period

- The subject has hyperkalemia (e.g. serum potassium ≥ 5.0 mEq/L at Week -8 and -4 in the pre-treatment period, or requiring regular use of a potassium adsorbent) or onset of hyperkalemia within 2 years prior to starting the pre-treatment period

- The subject has a renal disease other than type 2 diabetic nephropathy (e.g. patients with renal sclerosis, acute or chronic glomerular nephritis, or polycystic nephropathy).

- The subject has bilateral or unilateral renal artery stenosis

- The subject requires regular use of nonsteroidal anti-inflammatory drugs (excluding low-dose aspirin and locally-acting agents such as topical drugs) (e.g. rheumatoid arthritis patients, osteoarthritis patients, and low back pain patients)

- The subject has a history of any of the cardiovascular diseases listed below within 2 years prior to starting the pre-treatment period:

- Heart diseases: myocardial infarction, coronary arterial revascularization

- Cerebrovascular diseases: cerebral infarction (excluding lacunar infarction), cerebral hemorrhage, transient ischemic attack

- The subject has any of the cardiovascular diseases listed below:

- Heart diseases: angina pectoris, arrhythmia, and congested heart failure that requires medication

- Vascular diseases: arteriosclerosis obliterans with symptoms e.g. intermittent claudication

- The subject has a clinically significant hepatic disorder (e.g. either of ALT or AST is ≥ 2.5 times the upper limit of normal at starting the pre-treatment period (Week -8) or at Week -4 in the pre-treatment period)

- The subject has a complication of malignant tumor

- If female, the subject is pregnant or lactating, or is planning to become pregnant or donate her ova before signing the informed consent form, during the study period, or within 1 month after the end of the study

- If male, the subject intends to donate sperm during the course of this study or for 12 weeks thereafter

- The subject is judged by the investigator as being ineligible for any other reason

- The subject joined another clinical trial or post-marketing study within 30 days prior to starting the pre-treatment period

- The subject was administered the study drug within 12 weeks prior to starting the pre-treatment period

- The subject has a history of drug abuse (defined as the use of an illegal drug) or alcohol dependency within 2 years prior to starting the pre-treatment period

IN VIVO RAMAN SPECTROSCOPY OF HUMAN CAPILLARY BEDS:
The LighTouch device shines imperceptible red light into the skin and measures the light that comes back out using the method of Raman Spectroscopy. Some of this light is color shifted and some is not. Using a proprietary numerical recipe, the LighTouch device combines the signals in this remitted light and calculates hematocrit, glucose, protein and potentially other analytes. Thus the LighTouch device produces information without painful physical insult to the patient and can trend changes in these blood analytes in order to predict the need for intervention.
The leading preventable cause of death for all people between 18 and 45, world-wide, military or civilian is uncontrolled internal bleeding i.e. hemorrhage. (A. Sauaia et al, J. Trauma 38, 185-193 (1995)). Internal bleeding can be very difficult to reliably detect when there is no visible external injury and the rate of blood loss is not very rapid. Two known leading indicators of blood loss are fluctuations in hematocrit and blood protein concentration. Monitoring of either of these analytes requires a blood draw and at least 3-5 minutes to obtain a single measurement. The LighTouch device shines imperceptible red light into the skin and measures the light that comes back out using the method of Raman Spectroscopy. Some of this light is color shifted and some is not. Using a proprietary numerical recipe, the LighTouch device combines the signals in this remitted light and calculates hematocrit, glucose, protein and potentially other analytes. Thus the LighTouch device produces information without painful physical insult to the patient and can trend changes in these blood analytes in order to predict the need for intervention. Previous IRB approved clinical trials over the last 10 years demonstrated useful performance for blood glucose and now the hematocrit and protein analytes are ready to be tested. Since hematocrit and protein concentrations change during hemodialysis it provides an ideal model to monitor these fluctions over time and assess the precision and accuracy of the LighTouch device for these analytes. This technique will not affect the usual dialysis treatment in any way. The subject will place one finger into the machine for exposure to the incoming light signal and sensors within the machine will detect light scatter from specfic analytes such as hematocrit. Literally hundreds of individuals have experienced the LighTouch device since 1999 and there has never been an unpleasant response or adverse outcome. The system is analagous to having a laser pointer shining on one's finger-tip. The ultimate goal of this research is to develop the device into a reliable non-invasive measure of critical blood elements that can be determined at the patient's side.
stabel dialysis patients
Inclusion Criteria:

- adult stable on dialysis and able to consent

Exclusion Criteria:

- inability to acquire IVRS signal

USE OF ONEPIECE SUIT OR FORCED WARM AIR FOR PERIOPERATIVE TEMPERATURE CONSERVATION.:
To study if a one piece body suite (T-balance, Telespro, Finland) is equally effective in maintaining peri-operative body temperature as forced air warming, during open low-back surgery of medium duration.
Inclusion Criteria:

- ASA 1-3

- Approved consent

- Expected duration of open back surgery of 60-120 min

- Prestudy core temperature (oral) of at least 36 degrees C

Exclusion Criteria:

- Known diabetes mellitus

- Any known illness or use of pre-op drugs which may interfere with normal temperature regulation

- Body mass index less than 17 or more than 35

- Pregnancy

- Any contraindication for warming device or temperature monitor

JUVEDERM VOLUMA® XC FOR THE TREATMENT OF HYPOPLASTIC CHIN:
This is a single center study of the safety and efficacy of Juvedérm Voluma for the treatment of hypognathism.

- The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures

- The subject is either male or female and aged ≥ 20 to < 75 years at the time of consent

- The subject is an early-stage nephropathy (Stage 2) patient with type 2 diabetes mellitus

- The subject is a patient with type 2 diabetes mellitus on a certain diet therapy and/or exercise therapy (if any)

- The subject's blood glucose, blood pressure and lipid are stably controlled, and drug changes or dose changes of therapeutic drugs for hypertension, therapeutic drugs for diabetes mellitus, therapeutic drugs for dyslipidemia or hyperlipidemia are not required throughout the study period as judged by the investigator

- A male subject who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose

- A female subject of childbearing potential who is sexually active with a nonsterilized male partner who agrees to routinely use adequate contraception from signing of informed consent until 1 month after the completion of the study

Exclusion Criteria:

- The subject has received TAK-272 in a previous clinical study

- The subject is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may have given consent to participate under duress

- The subject has a history of hypersensitivity or allergies to TAK-272, candesartan cilexetil and other RAS inhibitors (ACE inhibitors, ARBs or DRIs)

- The subject needs to take the prohibited medications during the study period

- The subject has hyperkalemia (e.g. serum potassium ≥ 5.0 mEq/L at Week -8 and -4 in the pre-treatment period, or requiring regular use of a potassium adsorbent) or onset of hyperkalemia within 2 years prior to starting the pre-treatment period

- The subject has a renal disease other than type 2 diabetic nephropathy (e.g. patients with renal sclerosis, acute or chronic glomerular nephritis, or polycystic nephropathy).

- The subject has bilateral or unilateral renal artery stenosis

- The subject requires regular use of nonsteroidal anti-inflammatory drugs (excluding low-dose aspirin and locally-acting agents such as topical drugs) (e.g. rheumatoid arthritis patients, osteoarthritis patients, and low back pain patients)

- The subject has a history of any of the cardiovascular diseases listed below within 2 years prior to starting the pre-treatment period:

- Heart diseases: myocardial infarction, coronary arterial revascularization

- Cerebrovascular diseases: cerebral infarction (excluding lacunar infarction), cerebral hemorrhage, transient ischemic attack

- The subject has any of the cardiovascular diseases listed below:

- Heart diseases: angina pectoris, arrhythmia, and congested heart failure that requires medication

- Vascular diseases: arteriosclerosis obliterans with symptoms e.g. intermittent claudication

- The subject has a clinically significant hepatic disorder (e.g. either of ALT or AST is ≥ 2.5 times the upper limit of normal at starting the pre-treatment period (Week -8) or at Week -4 in the pre-treatment period)

- The subject has a complication of malignant tumor

- If female, the subject is pregnant or lactating, or is planning to become pregnant or donate her ova before signing the informed consent form, during the study period, or within 1 month after the end of the study

- If male, the subject intends to donate sperm during the course of this study or for 12 weeks thereafter

- The subject is judged by the investigator as being ineligible for any other reason

- The subject joined another clinical trial or post-marketing study within 30 days prior to starting the pre-treatment period

- The subject was administered the study drug within 12 weeks prior to starting the pre-treatment period

- The subject has a history of drug abuse (defined as the use of an illegal drug) or alcohol dependency within 2 years prior to starting the pre-treatment period

IN VIVO RAMAN SPECTROSCOPY OF HUMAN CAPILLARY BEDS:

The LighTouch device shines imperceptible red light into the skin and measures the light that comes back out using the method of Raman Spectroscopy. Some of this light is color shifted and some is not. Using a proprietary numerical recipe, the LighTouch device combines the signals in this remitted light and calculates hematocrit, glucose, protein and potentially other analytes. Thus the LighTouch device produces information without painful physical insult to the patient and can trend changes in these blood analytes in order to predict the need for intervention.

The leading preventable cause of death for all people between 18 and 45, world-wide, military or civilian is uncontrolled internal bleeding i.e. hemorrhage. (A. Sauaia et al, J. Trauma 38, 185-193 (1995)). Internal bleeding can be very difficult to reliably detect when there is no visible external injury and the rate of blood loss is not very rapid. Two known leading indicators of blood loss are fluctuations in hematocrit and blood protein concentration. Monitoring of either of these analytes requires a blood draw and at least 3-5 minutes to obtain a single measurement. The LighTouch device shines imperceptible red light into the skin and measures the light that comes back out using the method of Raman Spectroscopy. Some of this light is color shifted and some is not. Using a proprietary numerical recipe, the LighTouch device combines the signals in this remitted light and calculates hematocrit, glucose, protein and potentially other analytes. Thus the LighTouch device produces information without painful physical insult to the patient and can trend changes in these blood analytes in order to predict the need for intervention. Previous IRB approved clinical trials over the last 10 years demonstrated useful performance for blood glucose and now the hematocrit and protein analytes are ready to be tested. Since hematocrit and protein concentrations change during hemodialysis it provides an ideal model to monitor these fluctions over time and assess the precision and accuracy of the LighTouch device for these analytes. This technique will not affect the usual dialysis treatment in any way. The subject will place one finger into the machine for exposure to the incoming light signal and sensors within the machine will detect light scatter from specfic analytes such as hematocrit. Literally hundreds of individuals have experienced the LighTouch device since 1999 and there has never been an unpleasant response or adverse outcome. The system is analagous to having a laser pointer shining on one's finger-tip. The ultimate goal of this research is to develop the device into a reliable non-invasive measure of critical blood elements that can be determined at the patient's side.

stabel dialysis patients

Inclusion Criteria:

- adult stable on dialysis and able to consent

Exclusion Criteria:

- inability to acquire IVRS signal

USE OF ONEPIECE SUIT OR FORCED WARM AIR FOR PERIOPERATIVE TEMPERATURE CONSERVATION.:

To study if a one piece body suite (T-balance, Telespro, Finland) is equally effective in maintaining peri-operative body temperature as forced air warming, during open low-back surgery of medium duration.

Inclusion Criteria:

- ASA 1-3

- Approved consent

- Expected duration of open back surgery of 60-120 min

- Prestudy core temperature (oral) of at least 36 degrees C

Exclusion Criteria:

- Known diabetes mellitus

- Any known illness or use of pre-op drugs which may interfere with normal temperature regulation

- Body mass index less than 17 or more than 35

- Pregnancy

- Any contraindication for warming device or temperature monitor

JUVEDERM VOLUMA® XC FOR THE TREATMENT OF HYPOPLASTIC CHIN:

This is a single center study of the safety and efficacy of Juvedérm Voluma for the treatment of hypognathism.