linjc16/ctgov huggingface dataset:
Study to Determine the Impact of Multiple Doses of Rifampin on Single-dose Pharmacokinetics of HCV-796

Study Overview
=================
Brief Summary
-----------------
An open label, 2-period, sequential study to determine the impact of multiple doses of rifampin on single-dose pharmacokinetics of HCV-796

Official Title
-----------------
An Open Label, 2-period, Sequential Study to Determine the Impact of Multiple Doses of Rifampin on Single-dose Pharmacokinetics of HCV-796

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

Intervention / Treatment
-----------------
* Drug: Rifampin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rifampin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of multiple oral doses of rifampin on the pharmacokinetic (PK) profile of a single oral dose of HCV-796 in healthy subjects. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of HCV-796 and rifampin when coadministered to healthy subjects. |  |  |
Obstructive Sleep Apnoea in Patients With Intermittent Claudication

Study Overview
=================
Brief Summary
-----------------
The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.

Detailed Description
-----------------
In patients with peripheral artery disease (PAD), exercise induced limb ischemia (claudication) which limits walking capacity. Symptoms are due to pain at hip and/or buttock. Couple of origins may induce this pain such as vascular, cardiac, respiratory, musculoskeletal, neurologic, hematologic etc. The rate of associated respiratory pathology to patients with lower extremity artery disease (LEAD) is around 15%. The intolerance to walk could be link to an exercise hypoxia which appears with lower limb pain with or without associated dyspnea. The exercise hypoxemia becomes a diagnostic for an intermittent vascular claudication. Tests which are performed to diagnose an intermittent claudication are the Ankle to Brachial Systolic pressure Index (ABI), the echo-Doppler of lower limb arteries and the walking test on a treadmill associated to a measurement of the distal and chest transcutaneous oxygen pressure (tcpO2). Thus, the purpose of the present research is to determine the prevalence of obstructive sleep apnoea in patient with PAD.

Official Title
-----------------
Prevalence of Obstructive Sleep Apnoea in Patients With Intermittent Claudication

Conditions
-----------------
Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Register to the social health insurance Referred for a walk test because of claudication Maximal walking ditance < 750m Older than 18 years old Able to understand the protocol of the study Exclusion Criteria: Cardiac insufficiency already known, stage III or IV i.e. dyspnea at rest Unstable angina or myocardial infarction within the previous three months inclusion Severe reparatory disease already known Parkinson disease, hémiplégia ou paraplégia Does not want to participate to the protocol Pregnant women Adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research Being in a period of exclusion from another biomedical study

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

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 |
| --- | --- | --- |
| Prevalence of an Apnea hyponea index > 15 | Recording of sleep with the RESMED (Apnealink) system | up to 2 months after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OBSTRUCTIVE SLEEP APNOEA, INTERMITTENT CLAUDICATION, Respiratory disease, Peripheral artery disease
The Rate and Predictors of Vaginal Bleeding Among Women With Placenta Previa

Study Overview
=================
Brief Summary
-----------------
Placenta previa is usually diagnosed when the placenta implanted in the lower uterine segment, thus partially or totally overlying the internal os . It occurs with an incidence of 0.3-0.5%. It is associated mainly with prior caesarean delivery . The condition is frequently complicated by invasion of placental villi beyond the decidua basalis causing placenta accreta . Placenta previa is a major cause of massive haemorrhage during pregnancy and after delivery . The antepartum bleeding from placenta previa- can be life-threatening, thus, the prediction of this bleeding is of great importance . It is important to distinguish between women at high and low risk for antepartum haemorrhage with placenta previa especially at late pregnancy . However, the potential risk factors for antepartum haemorrhage in women with placenta previa have not been thoroughly examined.

Official Title
-----------------
The Rate and Predictors of Vaginal Bleeding Among Women With Placenta Previa: A Cross-sectional Study

Conditions
-----------------
Placenta Previa, Vaginal Bleeding, Antepartum Hemorrhage

Intervention / Treatment
-----------------
* Device: Ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women ≥ 28 weeks. Diagnosed to have placenta previa by ultrasound Exclusion Criteria: Women with complicated pregnancies (e.g. preeclampsia, diabetes mellitus and cardiac, renal, antiphospholipid syndrome). Women with premature rupture of membrane. Women who will refuse to participate.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ultrasonography|Abdominal ultrasound in pregnant women with placenta previa|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of vaginal bleeding in women presented by placenta previa at third trimester of pregnancy. | The rate of vaginal bleeding in women presented by placenta previa at third trimester of pregnancy. | Through study completion, an average of 1 and half year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of the potential clinical and ultrasonographic predictors of antepartum hemorrhage in women with placenta previa at third trimester of pregnancy | The result that the investigators will get from the study will help identify predictors of antepartum hemorrhage in pregnant women with placenta previa and hence preventing it, antepartum hemorrhage is a major life threatening complication of the disease wether to the baby or the mother | through study completion, an average of 1 and half year |
Geriatric Education and Its Effect on Certain Aspects of Hospital Care of the Nursing Home Patients - 12 Month Retrospective Study

Study Overview
=================
Brief Summary
-----------------
Nursing home patients admitted to the hospital poses significant challenge for health care providers. Geriatric teaching pays particular attention to these admissions and related problems. However, it yet to be proven, that geriatric training helps to overcome any of them in better way then non-geriatric education. The study aims to prove that geriatric care provides advantages over non-geriatric training in caring for nursing home patients admitted to the hospital.

Detailed Description
-----------------
Context Nursing home patients admitted to the hospital poses significant challenge for health care providers. Geriatric age, frailty, multiple readmissions, prolonged length of stay, and high mortality are just few attributes of nursing home patients in the hospital. Geriatric teaching pays particular attention to these challenging problems. However, it yet to be proven, that geriatric training helps to overcome any of them in better way then non-geriatric education. Objective To test the hypothesis that geriatric care provides advantages over non-geriatric training in caring for nursing home patients admitted to the hospital in regards to length of stay, rate of expirations and rate of readmissions. The secondary objective is to compare expirations and readmissions among patients cared for by geriatricians and non-geriatricians. Design, Setting, and Participants Retrospective cohort study of patients admitted from Metropolitan Jewish Geriatric Nursing Home (MJGNH) to Maimonides Medical Center (MMC) over 12 month period and under the care of geriatricians, non-geriatric internists, and surgeons. Comparison of the three study groups by age, sex, expiration rate, length of hospital stay (LOS) and readmission rate. Comparison of expired patients by age, sex and average LOS. Comparison of readmissions expiration rate, by preservation of continuity of care, by emergency room visits without admission.

Official Title
-----------------
Geriatric Education and Its Effect on Certain Aspects of Hospital Care of the Nursing Home Patients - 12 Month Retrospective Study

Conditions
-----------------
Frail Elderly, Elderly, Hospitalization, Geriatrics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients admitted to Maimonides Medical Center (MMC) from affiliated Metropolitan Jewish Geriatric Nursing Home (MJGNH)for '12 month period. Exclusion Criteria: none
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly, Hospitalization, Geriatrics, Mortality, Readmission, Length of Stay
The Beta Cell Responsiveness to Glucose-dependent Insulinotropic Polypeptide (GIP) With and Without Sulfonylurea in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that the impaired insulinotropic effect of the incretin hormone GIP may be due to inadequate sensitization and ATP induced closure of beta cell K-ATP channels. By closing the channels through the use of sulfonylurea (SU) we hope to restore the insulinotropic effect of GIP.

Official Title
-----------------
Phase 2 Study of The Beta Cell Responsiveness to GIP With and Without Sulfonylurea in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: Sulfonylurea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus diagnosed according to WHO criteria Diet and/or metformin treatment HbA1c > 7,0% for metformin treated patients HbA1c > 7,5% for diet treated patients Age: 18 years or older 25 > BMI > 40 kg/m2 Signed informed consent Sufficient birth control in case of child bearing capacity Exclusion Criteria: Proliferative retinopathy Diabetic nephropathy with s-creatinine > 130 microM and/or macroalbuminuria Liver disease (ALAT > 2 x normal value) CAD (NYHA group III or IV) Positive screening for islet-cell and/or GAD-65 autoantibodies Type 1 diabetes i first degree relatives Gastrointestinal surgery with intestinal resection Anemia Pregnancy and/or breastfeeding

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sulfonylurea|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Secretion | area under the curve AUC and insulin secretion rate | 0 - 90 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes mellitus, Glucose dependent insulinotropic polypeptide, Sulfonylurea compounds, insulin secretion, Sulfonylurea receptor subunit-SUR1, Impaired incretin effect
Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate the effects of a follow on formula containing the human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old infants.

Conditions
-----------------
Incidence of Infectious Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: Lactobacillus fermentum
* Dietary Supplement: Follow on formula without probiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6 months old children born at term written consent from parents Exclusion Criteria: frequent gastrointestinal disorders (frequent diarrhoeas, constipation episodes, gastroesophageal reflux) gastrointestinal surgery cow's milk protein allergy metabolic diseases (diabetes or lactose intolerance) immune deficiency antibiotic treatment during the trial and/or recent (within the preceding 3 weeks)

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 7 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>follow on formula with the probiotic Lactobacillus fermentum | Dietary Supplement: Lactobacillus fermentum<br> <br> |
| Active Comparator: Control<br>follow on formula without probiotics | Dietary Supplement: Follow on formula without probiotics<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of infectious diseases |  |  |
Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
This is the first multiple-dose study in humans with PRA-027. This study will provide an assessment of the safety, tolerability, pharmacokinetics (how the drug is absorbed, metabolized and excreted by the body) and pharmacodynamics (a measure of whether the drug is active in the body) of PRA-027 after administration of 28 days of oral doses in women of childbearing potential (cycling) or postmenopausal women.

Official Title
-----------------
A Randomized, Placebo-Controlled, Double-Blind, Sponsor-Unblinded, Multiple-Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PRA-027 Administered Orally To Cycling Or Postmenopausal Women

Conditions
-----------------
Uterine Leiomyomata (Fibroids)

Intervention / Treatment
-----------------
* Drug: PRA-027


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria - All Women Healthy, nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day and able to abstain from tobacco throughout all times when in the clinical facility. Inclusion Criteria - Cycling Women Aged 18 to 45 years, must not be breastfeeding, pregnant, or have a recent (within 90 days before pretreatment period day 1) history of pregnancy, with a history of regular menstrual cycles (21 to 35 days in duration). Inclusion Criteria - Postmenopausal Women Aged 35 to 65 years, menopause may be natural or due to surgery, natural amenorrhea must have begun by age of 55 years and have initiated at least 6 months before study day 1. Exclusion Criteria: Women with hysterectomy or complex or simple ovarian cysts greater than 3 cm in diameter. History of drug abuse (within 6 months) or alcoholism (within 12 months). History of female infertility.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: PRA-027<br>* PRA-027 capsules; cohort-specific doses or 40, 120, 240 or 500 mg; 1 dose daily for 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in cycling and postmenopausal women. |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide the PK and PD profile of multiple oral doses of PRA-027 in cycling and postmenopausal women. |  | 28 days |
Internet-based Stress Reduction Training for Students

Study Overview
=================
Brief Summary
-----------------
The main objective of the current study is to evaluate whether a mindfulness based intervention delivered online can provide an effective resource for increasing psychological well-being among students. In addition, explore potential mechanisms through which the training lead to improvements by means of mediational analyses, with hypothesized variables like positive/negative affect and attention regulation.

Official Title
-----------------
Internet-based Stress Reduction Training for Students - a Pilot Study

Conditions
-----------------
Depression, Stress

Intervention / Treatment
-----------------
* Behavioral: Online-MBSR
* Behavioral: Expressive Writing Online


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: current student have an active e-mail account regular use of the internet Exclusion Criteria: non-Swedish speaking

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online-MBSR<br>8 week mindfulness based stress reduction online | Behavioral: Online-MBSR<br>* 8 week mindfulness based stress reduction online<br>|
| Active Comparator: Expressive Writing Online<br>Online distributed expressive writing intervention as active control | Behavioral: Expressive Writing Online<br>* Online distributed expressive writing intervention as active control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological well-being | Change over time | Baseline, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression symptoms | Change over time | Baseline, Week 8 |
Renal Denervation in Patients With Refractory Hypertension

Study Overview
=================
Brief Summary
-----------------
To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.

Official Title
-----------------
Renal Denervation in Patients With Refractory Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: Ardian Symplicity™ Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >= 18 years of age. a systolic blood pressure of 160 mmHg or greater. receiving and adhering to full doses of an appropriate antihypertensive drug regimen for a minimum of two weeks prior to screening. agrees to have the study procedure(s) performed and additional procedures and evaluations, including repeat phlebotomy, imaging, urine analyses, and clinical examination. competent and willing to provide written, informed consent to participate in this clinical study. Exclusion Criteria: renal arterial abnormalities end stage renal disease requiring dialysis or renal transplant serum Cr > 3, or calculated GFR < 45 ml/min has experienced MI, unstable angina pectoris, or CVA with 6 months others

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Denervation<br>Renal denervation using the Symplicty Catheter | Device: Ardian Symplicity™ Catheter<br>* Renal denervation using the Symplicity Catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide confirmation that renal denervation is safe and feasible. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of renal denervation; indication of physiologic response; assessment of device performance. |  | 3 years |