linjc16/ctgov huggingface dataset:
Computer Based Training in CBT in Primary Care

Study Overview
=================
Brief Summary
-----------------
To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding CBT4CBT to treatment as usual in a community based primary care program in a population of 60 individuals who meet current DSM criteria for substance use disorder other than nicotine.

Detailed Description
-----------------
The investigators will conduct an initial evaluation of the computer program as an enhancement of treatment as usual in a community-based primary care clinic. Sixty individuals with a current DSM-IV alcohol or substance use disorder will be randomly assigned to either (1) treatment as usual, or (2) treatment as usual plus exposure to the 'CBT for CBT' program over a period of 8 weeks. Primary outcomes will be retention in treatment and reduction in drug use over 8 weeks. Secondary outcomes include treatment utilization

Official Title
-----------------
Computer Based Training in CBT in Primary Care

Conditions
-----------------
Substance Abuse

Intervention / Treatment
-----------------
* Behavioral: Standard Treatment As Usual (TAU)
* Behavioral: CBT4CBT program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are 18 years of age or older. Are applying for outpatient substance abuse treatment Meet current DSM-IV criteria for cocaine, marijuana, opioid, alcohol or other stimulant use disorder Are sufficiently stable for 8 weeks of outpatient treatment Can commit to 8 weeks of treatment and are willing to be randomized to treatment Are willing to provide locator information. Exclusion Criteria: Have an untreated bipolar or schizophrenic disorder Have a current legal case pending such that incarceration during the 8 week protocol is likely Are in need of detoxification from alcohol, opioids or benzodiazepines

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard treatment as usual (TAU)<br>Treatment normally offered at this primary care clinic | |
| Active Comparator: TAU plus CBT4CBT program<br>Treatment normally offered at this clinic PLUS 8 weeks of CBT4CBT computerized therapy. | Behavioral: Standard Treatment As Usual (TAU)<br>* Treatment normally offered at this primary care clinic<br>Behavioral: CBT4CBT program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retention in treatment | subjects returning for treatment at primary care unit and completing CBT4CBT program for those assigned | 0 - 8 weeks | 
| reduction in drug use | Using urine and breathalyzer screening for negative drug and alcohol testing | 0 - 8 weeks |
Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the diagnostic yield (at 1 month post enrollment) of an external loop recorder (SpiderFlash-T) in patients with syncope or palpitations of suspected arrhythmic origin, within 30 days before enrollment.

Detailed Description
-----------------
Diagnostic yield (primary outcome) definition = Number of patients with conclusive diagnosis (as per investigators' decision) over the total number of patients

Official Title
-----------------
Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)

Conditions
-----------------
Syncope, Palpitations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Syncope and/or palpitations events occurred in the last 30 days Events likely of arrhythmic origin No conclusive diagnosis established yet High probability of episodes recurrence (presence of at least one previous event in the last 12 months) Patient has signed the consent to participate to the study and/or to data treatment Exclusion Criteria: Inability to understand the purpose of the study or refusal to cooperate Expected low compliance with the recording technique. Logistical impossibility to deliver the ELR within 30 days after the index event (or after discharge from ER and/or hospitalization and/or clinic visit) Already included in other competitor clinical study Under guardianship Age less than 18

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 |
| --- | --- | --- |
| Evaluate the mean value of the diagnostic yield in one month | number of pts with a conclusive diagnosis (per investigators' decision) over the total number of patients | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield of the ELR stratified by each kind of diagnosed event, by week and by event occurred post enrollment |  | 1 month | 
| Recurrence rate stratified by syncope /palpitation, by week and by type of events occurred post enrollment |  | 1 month | 
| Analysis of arrhythmic vs non arrhythmic findings stratified by kind of index events (syncope /palpitations) |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Syncopal events, Palpitation events
Immunomodulation in GWI (Phlebotomy)

Study Overview
=================
Brief Summary
-----------------
Gulf War Illness and deployed veterans of the 1990-1991 Persian Gulf War are invited to have a brief history and physical examination to determine their health status, complete questionnaires, then donate about 83 ml of blood. There is no follow-up

Detailed Description
-----------------
Gulf War Illness and deployed veterans of the 1990-1991 Persian Gulf War are invited to have a brief history and physical examination to determine their health status, complete questionnaires, then donate about 83 ml of blood. There is no follow-up.

Official Title
-----------------
Immunomodulation in GWI (Phlebotomy)

Conditions
-----------------
Gulf War Illness

Intervention / Treatment
-----------------
* Other: Draw blood (phlebotomy, 83 ml)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kansas Criteria for GWI CDC criteria for CMI Exclusion Criteria: Chronic medical or psychiatric disorder that may be responsible for symptoms of GWI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Control<br>Deployed to 1990-1991 Persian Gulf War Do not meet Kansas Criteria for Gulf War Illness [Steele L. Prevalence and patterns of Gulf War illness in Kansas veterans: association of symptoms with characteristics of person, place, and time of military service. Am J Epidemiol. 2000 Nov 15; 152:992-1002. PubMed PMID: 11092441.] Good general medical and psychiatric health | Other: Draw blood (phlebotomy, 83 ml)<br>* Draw 83 ml of blood<br>* Other names: phlebotomy;|
| Gulf War Illness<br>Deployed to 1990-1991 Persian Gulf War Meet Kansas Criteria for Gulf War Illness [Steele L. Prevalence and patterns of Gulf War illness in Kansas veterans: association of symptoms with characteristics of person, place, and time of military service. Am J Epidemiol. 2000 Nov 15; 152:992-1002. PubMed PMID: 11092441.] plus Center for Disease Control criteria for Chronic Multisymptom Illness (CMI) [Fukuda K, Nisenbaum R, Stewart G, Thompson WW, Robin L, Washko RM, Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998 Sep 16;280(11):981-8. PubMed PMID: 9749480.] | Other: Draw blood (phlebotomy, 83 ml)<br>* Draw 83 ml of blood<br>* Other names: phlebotomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression in peripheral blood mononuclear cells | Determine mRNA expression in peripheral blood mononuclear cells (PBMCs) | After study recruitment, phleobotomy and mRNA quantification for all participants has been completed in June 2020 |
Effect of Treatment With Insulin Sensitizer on Arterial Properties, Metabolic Parameters and Liver Function in Patients With Nonalcoholic Fatty Liver Disease

Study Overview
=================
Brief Summary
-----------------
Abstract Background: Insulin resistance has an important role in the development of nonalcoholic fatty liver disease (NAFLD) and is involved in both pathological processes: hepatic steatosis and atherosclerosis. Therefore, treatment of NAFLD with insulin sensitizers is likely to have a favorable effect towards hepatic steatosis and cardiovascular outcomes. Objectives: The present study investigated the effect of metformin on arterial properties, metabolic parameters and liver function in patients with NAFLD. Methods In randomized, placebo controlled study, 63 patients with NAFLD were assigned to one of two groups: Group 1 received daily metformin; Group 2 received placebo. Pulse wave velocity (PWV) and augmentation index (AI) were performed using SphygmoCor (version 7.1, AtCor Medical, Sydney, Australia) at baseline and at the end of 4-month treatment period.. Metabolic measures and serum adiponectin levels were determined.

Conditions
-----------------
Nonalcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In a single-center study, 63 patients (32 males and 31 females) diagnosed with nonalcoholic fatty liver disease were recruited from the outpatient clinic and evaluated for the study. Exclusion Criteria: Patients with history of unstable angina, MI, CVA or major surgery within the six months preceding entrance to the study. Patients with unbalanced endocrine disease or any disease that might affect absorption of medications. Patients with plasma creatinine > 1.5 mg/dl, and electrolyte abnormalities.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin, Adiponectine, Arterial Compliance<br> | Drug: Metformin<br> <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
-----------------
nonalcoholic fatty liver disease, Pulse wave velocity, augmentation index, metformin
A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy

Official Title
-----------------
A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894 Versus Placebo in Subjects With Diabetic Neuropathic Pain

Conditions
-----------------
Diabetic Neuropathic Pain

Intervention / Treatment
-----------------
* Drug: ABT-894
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, age 18 to 75 If female, must be of non-childbearing potential or practicing birth control Has diabetes mellitus (Type 1 or 2) and a diagnosis of painful distal symmetric diabetic polyneuropathy Has had pain from distal symmetric diabetic polyneuropathy for a minimum of 6 months Must be willing to washout of all analgesic medications prior to entry into the study Exclusion Criteria: Has other conditions that may cause pain Currently receiving analgesic medications for conditions other than diabetic neuropathic pain Has a history of certain psychiatric diseases Has a history of certain heart or cardiovascular conditions Has any clinically significant recent infection, injury, or illness Current participation in another clinical study or participation within the past 30 days Is incapacitated, bedridden or confined to a wheelchair Is pregnant and/or breastfeeding Previous participation in this study or any other study with this investigational product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ABT-894<br>* 6 mg BID tablets, 8 weeks of treatment<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* BID tablets, 8 weeks of treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly mean of 24-hour average pain score |  | Change from Baseline to final | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain improvement from Baseline to the final evaluation |  | 8-week | 
| Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain |  | 8-week | 
| Global assessments of study drug and pain status |  | 8-week | 
| Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS) |  | 8-week |
Safety and Efficacy of G17DT Immunogen in the Treatment of Gastric and Gastroesophageal Cancer

Study Overview
=================
Brief Summary
-----------------
This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for gastric cancer.

Official Title
-----------------
Open-Label,Multicenter Study of G17DT Immunogen in Combination w/ Cisplatin and 5-FU in Subjects w/ Metastatic or Locally Recurrent Gastric or Gastroesophageal Cancer Previously Untreated With Chemotherapy.

Conditions
-----------------
Stomach Neoplasms, Esophageal Neoplasms

Intervention / Treatment
-----------------
* Biological: Treatment group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Clinical diagnosis with gastric or gastroesophageal cancer Karnofsky performance status score of at least 70 Life expectancy of at least 3 months Exclusion criteria: Prior treatment with chemotherapy or anticancer immunotherapy Bone marrow transplant within past year Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease Central nervous system metastases Immunodeficiency Hypercalcemia

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: Treatment Group<br>500µg G17DT administered on Weeks 1, 5 and 9 and an additional treatment at Week 25. Cisplatin was administered every 4 weeks on the first day of each treatment cycle as a 1 to 3 hour intravenous infusion at a dose of 100mg/m^2. 5-FU was administered every 4 weeks during the first 5 days of each cycle as a continuous intravenous infusion at a dose of 1,000 mg/m^2/d. | Biological: Treatment group<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of G17DT in combination with cisplatin and 5-FU chemotherapy on tumor response assessed by radiographic means. |  | Through Week 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the clinical efficacy of G17DT in combination with cisplatin and 5-FU chemotherapy as measured by time to disease progression, best overall response and survival. |  | Through Week 29 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroesophageal cancer, Gastric cancer
Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding

Study Overview
=================
Brief Summary
-----------------
Endometrial thickness has been used as an indicator of risk for endometrial hyperplasia and carcinoma in asymptomatic perimenopausal women. However, there is no cutoff value in perimenopausal women and the same thickness does not express the same endometrial volume in different endometrium because uterine lengths may be different and endometrial irregularities may exist. Many studies assessed endometrial volume measured by three-dimensional (3D) TVS as a predictor of malignancy in women with postmenopausal bleeding. To our knowledge there is no study assess endometrial volume measured by two dimension TVS in prediction of endometrial pathology, however it is cheap and available than 3D TVS.

Official Title
-----------------
Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding Endometrial Volume as a Predictor of Endometrial Pathology in Perimenopausal Uterine Bleeding

Conditions
-----------------
Endometrial Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: endometrial volume 2D TVS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: *perimenopausal women with abnormal bleeding e.g. menorrhagia, metrorrhagia and polymenorrhea. Exclusion Criteria: *general or local causes of bleeding, drug intake or recent hormonal contraception

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endometrial volume 2D TVS<br>perimenopausal women who bleed are examined by 2D TVS and the calculated endometrial volume using a specific formula and followed by endometrial biopsy for correlation with the pathological findings | Diagnostic Test: endometrial volume 2D TVS<br>* calculation the endometrial volume using 2D ultrasound and correlation the results with the pathological findings of endometrial biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of measurement of endometrial volume by 2D TVS in prediction of endometrial pathology |  | 1year |
VALENCE: Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to show that valsartan compared to atenolol has favorable effects on exercise capacity, quality of life, diastolic function and elevated blood pressure in hypertensive postmenopausal overweight women with impaired exercise tolerance despite normal left ventricular ejection fraction (LVEF).

Official Title
-----------------
A 26-week Double-blind, Randomized, Multicenter Parallel-group Trial to Compare the Effects of Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women With Impaired Exercise Tolerance

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

Intervention / Treatment
-----------------
* Drug: valsartan
* Drug: atenolol
* Drug: hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) must be ≥ 27 and < 35 Symptoms of impaired exercise capacity (e.g. who report shortness of breath on exertion when questioned) reported at Visit 1 or patients who have a history of shortness of breath which improved under diuretic therapy LV ejection fraction must be > 45% measured by echocardiography at Visit 2. Impaired exercise capacity measured by VO2max at Visit 4: VO2max >14 and < 22 ml ⋅kg-1 ⋅min-1 Exclusion Criteria: Mean sitting diastolic blood pressure (MSDBP) ≥ 110 mmHg and/or Mean sitting systolic blood pressure (MSSBP) ≥ 180 mmHg LVEF ≤ 45 % Inability to completely discontinue all previous antihypertensive medications safely for the duration of the study Heavy smokers (>20 cigarettes/day)

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: valsartan|nan|
|Drug: atenolol|nan|
|Drug: hydrochlorothiazide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in exercise capacity measured by oxygen consumption during exercise testing, after 26 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic heart function after 26 weeks, measured by echocardiography |  |  | 
| Change from baseline in heart rate and blood pressure, |  |  | 
| during exercise testing after 26 weeks |  |  | 
| Change from baseline in heart size after 26 weeks, measured by echocardiography |  |  | 
| Change from baseline in quality of life measures after 26 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postmenopausal, women, overweight, hypertension, impaired, exercise, capacity, valsartan, atenolol, hydrochlorothiazide