linjc16/ctgov huggingface dataset:
Thalidomide for Patients With Mild to Moderate Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
This is a 24-week, randomized, double-blind, placebo-controlled study of the effect of thalidomide and placebo on CSF (cerebral spinal fluid) and plasma biomarkers in patients with mild to moderate Alzheimer's disease. This study will evaluate the effects of 24 weeks of treatment with Thalidomide on plasma biomarkers.

Detailed Description
-----------------
A lumbar puncture will be done before treatment (baseline), and at 24 weeks to collect CSF for the quantification of biomarkers. As an exploratory effort, we will test the effects of thalidomide on the same biomarkers in the plasma and will determine if detectable changes mirror changes observed in the CSF.

Official Title
-----------------
Twenty-Four-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fixed Dose Regimens of Thalidomide and Placebo on CSF and Plasma Biomarkers in Patients With Mild to Moderate Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Thalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have a screening diagnosis of Probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria. Subjects must have a Mini-Mental State Examination (MMSE) score of 12-26 Subject must live at home. Must have a caregiver to participate in this study

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Thalidoide<br>CSF | Drug: Thalidomide<br>* fixed dose over 8 clinic visits<br>* Other names: Celegene;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve cognition |  | 2 years |
Sensitivity Study of Diagnostic for Detection of Chagas Infection

Study Overview
=================
Brief Summary
-----------------
This study is a multi-site trial assessing the sensitivity of Chagas Detect™ Plus rapid test versus standard reference tests (e.g. IFA, IHA, RIPA) for Chagas diagnosis. The Chagas Detect™ Plus rapid test serves as an aid in the clinical laboratory diagnosis of Chagas infection in patients. This test is intended to be used on human whole blood or serum samples. Chagas Detect™ Plus results (positive or negative) must be confirmed by testing with a reference standard test. Subjects will be patients at clinical sites located in Chagas-endemic areas. After informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected. One is blood from finger prick, and the other is blood from venous puncture (drawn from vein in arm). Rapid tests and reference tests will be performed by different operators who are laboratory staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently.

Official Title
-----------------
Determination of Estimated Sensitivity for Chagas Detect Plus Rapid Tests

Conditions
-----------------
Infectious Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All age groups and both sexes for archive samples, adults only and both sexes for prospective samples. Samples collected from subjects living in T. cruzi endemic regions. Information must be available about symptoms, age, and sex of patient from which samples are collected. The location of sample collection must be recorded. Exclusion Criteria: Archived samples with linked personal identifiers or any sample for which personal information can be discovered. Prospective samples from nursing home residents; inmates/subjects in police custody; participants who are unable to understand verbal or written local language in which a certified translation of the informed consent is available, or requires a Legal Authorized Representative (LAR) for consent. Subject serum specimens that have undergone more than 2 freeze-thaw cycles or that have not been stored frozen.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of subjects with positive result |  | 1 day |
Prospective L-arginine Study

Study Overview
=================
Brief Summary
-----------------
HYPOTHESIS The investigators primary hypothesis is that peripheral endothelial function and exercise tolerance will be abnormal in the population of young heart transplant patients at baseline, and that each will show a trend towards improvement following a 12 week course of oral L-arginine, with regression towards the baseline following the 12 week washout period.

Official Title
-----------------
Effect of Chronic Oral L-arginine Supplementation on Peripheral Endothelial Function and Exercise Tolerance in a Population of Young Heart Transplant Patients.

Conditions
-----------------
Heart Transplant

Intervention / Treatment
-----------------
* Drug: L-arginine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: University of Michigan Pediatric Heart Transplant Clinic patient. Greater than or equal to 8 years of age. Heart transplant between 1 and 8 years prior to enrollment in the study Exclusion Criteria: Relative hypotension for age Refusal to participate Inability to cooperate with Endo-PAT testing Pregnant or nursing women. Insulin dependent diabetes

Ages Eligible for Study
-----------------
Minimum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-arginine<br> | Drug: L-arginine<br>* All study subjects will be treated with a 12 week (11-13 week) course of oral L-arginine at a dose of 6 g per day, divided into morning and evening doses of 3 g (3 1000 mg capsules or caplets).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peripheral endothelial function from baseline following 12 week treatment course of L-arginine. | Endothelial function will be assessed at baseline as well as after a 12 week treatment course of L-arginine. A final measurement will be made following a 12 week washout period. | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in serum levels of oxidative stress markers | Serum markers of oxidative stress will be measured at baseline and after a 12 week treatment course of L-arginine. A final measurement will be made after a 12 week washout period. | baseline and 12 weeks | 
| Change in exercise tolerance from baseline following a 12 week treatment course of L-arginine | Exercise tolerance will be assessed with a 6 minute walk at baseline and following a 12 week treatment course of L-arginine. A final measurement will be made after a 12 week washout period. | baseline and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients
Uterotonics for Severe Preeclampsia

Study Overview
=================
Brief Summary
-----------------
The study compares the effect of Intravenous carbetocin versus combined use of intravenous oxytocin and rectal misoprostol for prevention of postpartum hemorrhage during delivery of women with severe preeclampsia

Official Title
-----------------
Carbetocin Versus Combined Oxytocin and Misoprostol for Prevention of Postpartum Hemorrhage in Women With Severe Preeclampsia

Conditions
-----------------
Preeclampsia Severe

Intervention / Treatment
-----------------
* Drug: Carbetocin
* Drug: Oxytocin
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women which diagnosed with severe pre-eclampsia. Singleton pregnancy. Termination of pregnancy by Cesarean section after 28 weeks of gestation. Exclusion Criteria: Suspected or proven placental abruption. Known placenta Previa or acreata. Multiple pregnancies. Obesity (BMI >35). Anemia (<9 g/dl). Retained placental tissues. Big baby (> 4 kg). Presence of coagulopathy. Polyhydramnios. Presence of Uterine fibroids. Medical diseases as; cardiac, liver, renal or endocrine diseases. General anesthesia.
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbetocin<br>Patient received 100 mcg of carbetocin intravenous over one minute immediately after delivery of the baby. | Drug: Carbetocin<br>* 100 mcg of Carbetocin intravenous injection<br>|
| Active Comparator: Oxytocin plus misoprostol<br>Patient received 10 units of oxytocin IV drip and 400 mcg of misoprostol rectally after anesthesia. | Drug: Oxytocin<br>* 10 IU oxytocin IV drip<br>Drug: Misoprostol<br>* 400 mcg rectal<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of postpartum hemorrhage more than 1000 ml | the amount of bleeding during and after CS | 30 minutes |
Non-invasive, Real-time Anesthetic Drug-monitoring System

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine efficacy of the CorrecDose device to continuously and non-invasively follow the changes in propofol concentrations in the participants' blood.

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Device: CorrecDose Infrared Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who have signed Informed consent form Women undergoing Trans vaginal ovum retrieval (TVOR) for invitro fertilization (IVF) and will be sedated with propofol administered intravenos (IV) Exclusion Criteria: Women with background diseases Women with chronic use of drug and medication Women with peripheral blood vessels problems Women with high blood pressure Women with body mass index (BMI) score over 35 or less than 18

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Propofol sedated patients<br>Women undergoing a short trans vaginal ovum retrieval (TVOR) will be sedated with propofol , and monitored non-invasively for changes in blood propofol concentration levels. Propofol dosages will be adapted according to patients vital signs and their reaction to noxious stimuli exerted during the trans vaginal ovum retrieval (TVOR) procedure, irrespective to the proposed study in which these participants undergo.Those changes of administered propofol dosages will be observed by the anesthetic drug monitor (ADM). Propfol is administered by the anesthesiologist in a routine manner and according to anesthesiologist discretion . | Device: CorrecDose Infrared Monitor<br>* The monitor is attached to patient's wrist and ear in order to measure changes in propofol concentrations in blood<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Propofol Blood Levels | Graphic display on monitor of real-time changes | Half hour |
A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will compare the safety, tolerability and efficacy of aleglitazar and Actos in patients with type 2 diabetes and symptomatic NYHA class II heart failure. Eligible patients will be randomized to receive either aleglitazar, titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily, or Actos, titrated to an individual maximum tolerated dose up to 45mg p.o. daily, in addition to prescribed diabetes therapy where applicable. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Double Blind Study to Compare the Safety and Tolerability of Aleglitazar and Actos in Patients With Type 2 Diabetes and NYHA Class II Heart Failure.

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Drug: Actos
* Drug: aleglitazar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; type 2 diabetes for >=1 month; drug naive, or receiving stable doses of <=2 oral antihyperglycemic medications; HbA1c 6.5-10.0% at screening; symptomatic, stable NYHA class 2 heart failure at screening. Exclusion Criteria: type 1 diabetes; current or previous treatment with insulin; uncontrolled hypertension; NYHA class 1, 3 or 4 at screening.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Actos<br> | Drug: Actos<br>* Titrated to an individual maximum tolerated dose up to 45mg p.o. daily<br>|
| Experimental: Aleglitazar<br> | Drug: aleglitazar<br>* Titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period. |  | 26 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period, adverse events (AEs), laboratory parameters. |  | 26 week | 
| Efficacy: Change from baseline to week 26 in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), fasting plasma insulin (FPI) and lipid profile. |  | 26 week |
Serum Biomarker of Plaque Vulnerability and Contrast Ultrasound of Carotid Artery

Study Overview
=================
Brief Summary
-----------------
No serum biomarker has qualified for clinical use until now. However several biomarkers, especially markers of inflammatory or proteolytic activity seem to promising in the identification of vulnerable plaques. Moreover, recent study confirmed that contrast-enhanced ultrasound imaging(CEUS) can visualize intraplaque neovascularization and represent the plaque vulnerability. In this study we try to identify indicators through analysis of the relationship between plaque neovascularization seen by CEUS and well known biomarkers such as serum matrix metalloproteinase(MMP)-2, MMP-9, cathepsin family(L,S,V), cystatin C, lipoprotein phospholipase A2, and hs-crp

Official Title
-----------------
Can Serum Biomarker of Plaque Vulnerability be Identified Through the Contrast-enhanced Ultrasound of Carotid Artery

Conditions
-----------------
Intraplaque Neovascularization Evaluated by Carotid Enhanced Ultrasound Well Reflect the Plaque Vulnerability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with carotid plaques size more than 2mm by carotid ultrasound Exclusion Criteria: known allergy to albumin, or to the ultrasound contrast agent the patients with history of carotid endarterectomy and carotid stent acute myocardial infarction, cardiogenic shock connective tissue disease and malignancy creatinine clearance lower than 30ml/min and the history of dialysis
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration of Biomarker that is statistically significant different according to the presence of intraplaque neovascularization on contrast enhanced ultrasound of carotid artery |  | after performing contrast enhanced ultrasound of carotid artery, upto 3 hospital days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of the patients with history of cardiovascular event including myocardial infarction, cerebral vascular event and peripheral arterial disease and the number of 1 year clinical outcome of cardiovascular event |  | after performing contrast enhanced ultrasound of carotid artery, upto 1 year clinical follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomarker, Carotid enhanced ultrasound, Intraplaque neovascularization
The Effect of Liquorice on Plasma Potassium

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that liquorice lowers plasma potassium. This study aims to elucidate the dose-response of this effect with two doses of liquorice (66 grams or 102 grams) per day for two weeks.

Official Title
-----------------
Lakritsin Vaikutus Kaliumpitoisuuteen

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Liquorice 66 g/day
* Other: Liquorice 102 g/day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers age 18-40 Exclusion Criteria: any continuous medication hypertension or hypotension allergy to liquorice pregnancy or lactation difficult venipuncture drug or alcohol abuse participation in pharmaceutical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liquorice 66 g/day<br>Liquorice given 66 grams per day for two weeks | Other: Liquorice 66 g/day<br>* Liquorice 66 g/day for two weeks<br>* Other names: Pepe Original liquorice;|
| Active Comparator: Liquorice 102 g/day<br>Liquorice given 102 grams per day for two weeks | Other: Liquorice 102 g/day<br>* Liquorice 102 g/day for two weeks<br>* Other names: Pepe Original liquorice;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma potassium |  | 1 week, 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteers
A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Patch Applied To The Skin

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the single-dose pharmacokinetics, safety, and tolerability of a varenicline patch applied to the skin.

Official Title
-----------------
A Phase 1, Open-Label, Single Dose Study To Characterize The Pharmacokinetics Of A Varenicline (CP-526,555) Transdermal Delivery System Applied To The Skin Of Adult Smokers

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: varenicline free base patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, Caucasian, male, adult light to regular smokers Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Any condition possibly affecting drug absorption through the skin (eg, psoriasis).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Varenicline transdermal delivery system<br> | Drug: varenicline free base patch<br>* varenicline transdermal delivery system (6.0 mg payload [drug amount loaded in each patch]) will be applied to the upper back over a single 24 hour period<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Varenicline area under the curve from 0 to infinity (AUCinf) and varenicline area under the curve from 0 to the last quantifiable concentration (AUClast), as data permit |  | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of adverse events (including skin irritation) |  | 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
varenicline percutaneous transcutaneous topical transdermal transdermal delivery system patch