linjc16/ctgov huggingface dataset:
A Phase 2, Single-Arm, Open-Label Study Evaluating the Efficacy and Safety of Single Agent GS 1101 (CAL 101) as Therapy for Previously Treated Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of GS-1101 on the onset, magnitude, and duration of tumor control

Detailed Description
-----------------
This is a Phase 2, multicenter, single-arm, controlled, clinical trial evaluating the efficacy and safety of the phosphatidylinositol 3-kinase delta (PI3K-delta) inhibitor GS-1101 (CAL-101) as therapy for previously treated chronic lymphocytic leukemia. This clinical trial (Study GS-US-312-0120) is a single-arm in which compliant subjects from GS US-312-0119 -Arm B who experience progression of CLL while receiving single-agent ofatumumab therapy are potentially eligible to receive single-agent, open-label GS 1101 therapy.

Official Title
-----------------
A Phase 2, Single-Arm, Open-Label Study Evaluating the Efficacy and Safety of Single Agent GS 1101 (CAL 101) as Therapy for Previously Treated Chronic Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: GS-1101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in Study GS-US-312-0119 Occurrence of confirmed progression of CLL while receiving single-agent ofatumumab in Study GS US 312 0119. Permanent cessation of Study GS-US-312-0119 (single-agent ofatumumab) and no intervening or continuing therapy (including radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of CLL. The time from permanent cessation of single-agent ofatumumab on Study GS-US-312-0119 and the initiation of GS 1101 on Study GS-US-312-0120 is no more than 12 weeks.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GS-1101<br>GS-1101 (oral; 150 mg BID) | Drug: GS-1101<br>* 150 mg taken twice daily by mouth<br>* Other names: CAL-101;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 18 mon | 
| Patient Well-Being | Health-related quality-of-life questionnaire | 18 months | 
| Disease-related Biomarkers |  | 18 months | 
| Pharmacokinetics | Evaluation of plasma concentrations at peak (Cmax) and trough (Cmin) | 6 months | 
| Incidence of Adverse Events |  | 18 months | 
| Health Resource Utilization |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Lymphocytic Leukemia, CLL, CAL-101, Ofatumumab
Safety & Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With Asthma

Study Overview
=================
Brief Summary
-----------------
This study is to confirm the safety of Symbicort® Turbuhaler® 160/4.5 µg 1, 2 or 4 inhalation b.i.d. over a 52 week treatment period in asthmatic patients who are being treated with IGCS and long acting β2-agonist (LABA) and/or other anti-asthmatic drugs.

Official Title
-----------------
An Open, Phase III, Multicentre, 52-week Study, Evaluating the Safety and Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Budesonide/Formoterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma with a documented history of at least 6 months duration prior to Visit 1 Prescribed daily use of an IGCS for ≥12 weeks prior to Visit 1 Prescribed daily use of at least one of the following: Theophylline, long acting β2-agonist (LABA), other anti-asthmatic drugs (leucotrine antagonists, inhaled anti-cholinergics, Th2 cytokine inhibitor) for at least 4 weeks prior to Visit 1 at a constant dose Exclusion Criteria: Any significant disease or disorder that may jeopardize the safety of the patient Respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to Visit 1 Treatment with oral, parenteral or rectal GCS within 4 weeks prior to Visit 1

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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: Budesonide/Formoterol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Adverse events (nature, incidence and severity) Haematology, clinical chemistry, morning plasma cortisol, urinalysis, and ACTH challenge test 12-lead ECGs, blood pressure, pulse rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes regarding disease status (incl. PEF), collected via diaries |  |  | 
| Forced expiratory volume in one second (FEV1) |  |  | 
| - all variables assessed over the 52 week treatment period |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma
Acute Effects of Dietary Proteins on Postprandial Lipemia, Incretin Responses and Subclinical Inflammation in Obese Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of dietary protein on blood lipids and gut hormones after a fat-rich meal. Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream following a fat rich meal. The effect is dependant of both the quality and the quantity of protein ingested.

Official Title
-----------------
Acute Effects of Dietary Proteins on Postprandial Lipemia, Incretin Responses and Subclinical Inflammation in Obese Subjects

Conditions
-----------------
Obesity, Postprandial Lipemia, Atherosclerosis, Inflammation, Postprandial Incretins

Intervention / Treatment
-----------------
* Dietary Supplement: Caseine
* Dietary Supplement: Cod
* Dietary Supplement: Gluten
* Dietary Supplement: Whey Isolate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 30 kg/m2 & < 45 kg/m2 Exclusion Criteria: Diabetes Lipid lowering drugs Liver-, Kidney- and/or Heart Disease Serious Hypertension (160/110)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whey Isolate<br> | Dietary Supplement: Whey Isolate<br> <br> |
| Active Comparator: Caseine<br> | Dietary Supplement: Caseine<br> <br> |
| Active Comparator: Cod<br> | Dietary Supplement: Cod<br> <br> |
| Active Comparator: Gluten<br> | Dietary Supplement: Gluten<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride |  | 0h- 2h- 4h- 6h- 8h postprandial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incretins |  | 0h -1h -2h -4h -6h -8h Postprandial | 
| Inflammatory markers |  | 0h- 1h- 2h- 4h- 6h- 8h postprandial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postprandial Period, Postprandial Lipaemia, Incretins, Subclinical Inflammation, Obesity, Atherosclerosis, Triglyceride, Lipoproteins, Postprandial inflammation
Study Examining Stress During Pregnancy

Study Overview
=================
Brief Summary
-----------------
Researchers at UVa Health System are interested in how women experience and deal with stress during pregnancy. Participants will be randomly assigned either to engage in coping strategies on one's own or to receive 6 weeks of relaxation training. Researchers will examine how coping strategies affect the course of the pregnancy and the health of the infant

Detailed Description
-----------------
Participants will be asked to fill out questionnaires and complete some tasks that require concentration as heart rate and other biological signals are monitored. Participants will also be asked to provide samples of saliva a few times during 1 day. These tasks will be repeated 3 times during pregnancy and participants will be asked to complete questionnaires at 6 months postpartum A stress-reduction workshop will be offered to all participants at the completion of the study. Participants will be paid for study completion

Official Title
-----------------
Coping With Stress During Pregnancy

Conditions
-----------------
Stress

Intervention / Treatment
-----------------
* Behavioral: Relaxation Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: beginning of the 2nd trimester of pregnancy feel stressed or overwhelmed do not yet have any children Exclusion Criteria: more than 1 miscarriage currently receiving medication for anxiety or depression

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br> | |
| Experimental: 2<br>Relaxation techniques | Behavioral: Relaxation Training<br>* Relaxation techniques training<br>|

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
-----------------
pregnancy, stress, anxiety
Vessel Wall MR Imaging to Explore Sex-Differences of Intracranial Arterial Wall Changes After Suspected Stroke

Study Overview
=================
Brief Summary
-----------------
Despite advances in stroke care, women continue to face worse outcomes after stroke than men. This disparity in outcomes may be related to biologic sex-differences that manifest in the development and progression of atherosclerosis. Decades of cyclic changes in the hormonal milieu lead to different metabolic profiles in women. These changes may also explain sex-differences in risk factor profiles of atherogenesis and plaque composition. The investigators' objective is to conduct a cross-sectional MR imaging study of suspected stroke patients to compare the burden and composition of intracranial atherosclerosis and risk factors between men and women. Results from this study are expected to show that sex and sex-specific risk factors should be considered at the outset of stroke evaluation for risk-stratification. In the era of precision medicine, the investigators propose the role of sex should be a starting point in the clinical evaluation of stroke.

Official Title
-----------------
Vessel Wall MR Imaging to Explore Sex-Differences of Intracranial Arterial Wall Changes After Suspected Stroke

Conditions
-----------------
Intracranial Atherosclerosis, Acute Stroke, Transient Ischemic Attack

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years Suspected stroke patients No contraindications for an MRI exam or gadolinium intravenous contrast No need for an emergent interventional treatment (e.g., thrombectomy) Exclusion Criteria: Younger than 18 years Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases with stroke<br> | |
| Controls without stroke<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of intracranial arterial wall abnormalities by sex. | Vessel wall imaging characteristics on multicontrast MR imaging | 1 day (Evaluated at time of clinical presentation). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intracranial atherosclerotic disease, acute stroke, transient ischemic attack, vessel wall imaging
Genetics of Arteriovenous Malformations

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to identify genetic alterations resulting in the development of arteriovenous malformation (AVM) in the central nervous system.

Detailed Description
-----------------
The study will include AVM patients and members of their nuclear family. All patients will donate a sample of saliva (5 mL) or blood (10 mL). Basic demographic and clinical parameters will be collected, including ethnicity, age at first presentation, symptoms at presentation, history of subsequent symptoms, treatment history, Spetzler-Martin AVM grade, medication history, and other pertinent medical information. In patients undergoing AVM resection, a small sample of the AVM will be collected for concurrent genomic analysis. Family members will donate saliva (5mL) and document their relationship to the patient (i.e., parent, sibling, child, etcl). Nucleic acids will be isolated from the saliva/blood samples, and genetic sequencing will be carried out. When a surgical sample of the AVM is available, nucleic acids will be obtained and transcriptome profiling will be performed. Identification of genetic alterations common to patients with AVM and not present in samples from parents and siblings will greatly aid in identification of pathways associated with AVM formation. Candidate sequences will be chosen by differential expression (p<0.05) and fold-changes. Once identified, mechanisms for the rapid detection of marker sequences will be developed and their predictive value tested in future collections.

Official Title
-----------------
Genetics of Arteriovenous Malformations

Conditions
-----------------
Arteriovenous Malformation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 6 and 60 years inclusive Diagnosis of AVM or nuclear family member of a patient with AVM Grants access to saliva, blood, and/or tissue Exclusion Criteria: Age less than 6 years or greater than 61 years Nuclear family members who do not share the same parents as the AVM patient

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 60 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of genetic alterations common to patients with AVM |  | sample analysis will take an expected average of six weeks |
Effect of High Protein Diet on Cardiovascular Diseases Risk Factors Among Overweight and Obese Children

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children.

Detailed Description
-----------------
Background: Studies regarding the effects of high protein (HP) diet on cardiovascular (CVD) risk factors have reported contradictory results. Objective: In present study, the investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children. Design: In this randomized controlled trial, the investigators recruited 50 overweight and obese women, aged 6-11years into HP or control energy restricted diets for 10 weeks (protein, carbohydrate, fat: 25%, 45%, 30% vs. 15%, 55%, 30%, respectively). Total protein amount, divided to animal and plant sources in 50%-50% and animal sources distributed (half/half) between meats and dairy products. Fasting blood samples, lipid profile, systolic and diastolic blood pressure and anthropometric measurements were measured based on the standard guidelines.

Conditions
-----------------
Body Mass Index Quantitative Trait Locus 7 Disorder, Tangier Disease

Intervention / Treatment
-----------------
* Other: nutrition intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 85th age of 6-11 years no history of chronic diseases no taken medications Exclusion Criteria: do not prescribe their diet mental retardation

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nutrition intervention<br>high protein diet | Other: nutrition intervention<br>* high protein diet<br>|
| No Intervention: no intervention<br>control diet | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the amount of weight reduction in two dietary groups | weight reduction (kg) | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL (mg/ml) |  | 10 weeks | 
| HDL (mg/ml) |  | 10 weeks | 
| fasting blood glucose |  | 10 weeks | 
| total cholesterol (mg/dl) |  | 10 weeks | 
| blood pressure |  | 10 weeks |
Treatment of Localized Low Grade Lymphomas

Study Overview
=================
Brief Summary
-----------------
To compare localiezd radiotherapy to localized radiotherapy followed by 6 cycles of chemotherapy in the treatment of localiezd low grade lymphoma

Detailed Description
-----------------
The standard treatment ol localized low grade lymphomas is Radiotherapy alone can offer long term remissions to some patients . No study have clearly demonstrated the interest of chemotherapy. The purpose of the study is to determine wether prednisone administrated after first line local radiotherapy (30 GY) can pre in the treatment of localized low grade lymphomas of adult patients

Official Title
-----------------
Phase III Study of Treatment of Localized Lymphomas: Radiotherapy Versus Radio-Chemotherapie

Conditions
-----------------
Lymphoma, Low-Grade

Intervention / Treatment
-----------------
* Procedure: radiotherapy
* Drug: MINI CHEP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low grade lymphoma defined according to the Ann Arbor classification localized Exclusion Criteria: Subjects unable to signed informed consent Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radiotherapy<br>minichep + radiotherapy | Procedure: radiotherapy<br>* mini chep+ radiotherapy<br>|
| Active Comparator: B<br>MINI CHEP | Drug: MINI CHEP<br>* chemotherapy minichep 6 courses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure free survival at 5 years |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival at 5 years |  | 5 years | 
| response rates at the end of the treatment |  | 6 months | 
| prognstic value of molecular analyses in blood and marrow |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
localized low grade lymphoma, Chemotherapy, Radiotherapy, Molecular analyses, primary