linjc16/ctgov huggingface dataset:
Therapist Adherence to Cognitive-behavioral Therapy

Study Overview
=================
Brief Summary
-----------------
An observational web-based survey on therapist adherence to evidence-based cognitive-behavioral therapy (CBT) in the perspective of their patients with depression or anxiety disorders in psychiatric outpatient care in Stockholm, Sweden. Following completion of CBT, participants respond to questions including their age, gender, education, whether they have improved, whether they considered treatment helpful, and an instrument measuring therapist adherence to CBT procedures (e.g., setting agenda, follow up on home assignments) and CBT techniques (e.g., exposure, cognitive restructuring). The purpose of the study is to contribute to quality assurance of CBT in Stockholm Health Care Services.

Official Title
-----------------
Therapist Adherence to Evidence-based Cognitive-behavioral Therapy in a Patient Perspective

Conditions
-----------------
Anxiety Disorders, Depression

Intervention / Treatment
-----------------
* Behavioral: Cognitive-behavioral therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A primary diagnosis of major depressive disorder, social anxiety disorder, panic disorder, agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, or illness anxiety disorder 18 years of age or older Just completed individual cognitive-behavioral therapy in psychiatric outpatient care in Stockholm, Sweden Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Psychiatric patients<br>Psychiatric outpatient care patients with major depressive disorder, anxiety disorders, post-traumatic stress disorder, obsessive-compulsive disorder, or illness anxiety disorder who have just completed cognitive-behavioral therapy. | Behavioral: Cognitive-behavioral therapy<br>* Cognitive-behavioral therapy including both behavioral and cognitive interventions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Cognitive-Behavioral Therapy Scale - Patient Version | Patients rate the degree to which therapists adhere to evidence-based cognitive-behavioral therapy procedures and techniques on a Likert-type scale from 0 (Not at all) to 4 (To a very high degree) | Up to 20 weeks |
6 FEC 100 Vs 4 FEC 100 Followed by 4 Taxol in N+ Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The main objective of this randomized trial is to compare 6 FEC100 to 4 FEC100 + 4 Taxol in patients with resected node positive breast cancer. Main endpoint is disease free survival. Secondary endpoints are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 840 patients have been included in the trial.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: 6 FEC 100
* Procedure: 4 FEC 100 followed by 4 Taxol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven cancer of the breast, Mastectomy or complete tumorectomy, Histologically proven homolateral, axillary lymph node involvement (at least 1 N+) Period between surgery (second operation in case of primarily incomplete resection) and the start of chemotherapy < 2 months, Biological criteria (before the first FEC cycle): Neutrophils >1.5 109 /L Platelets >100 109/L Hemoglobin >10 g/dl Creatininemia <120 mmol/1 Bilirubinemia <1.5 Upper normal value Female patients over 18 years old Written and signed informed consent Performance Status less than or equal to 2 (WHO scale, see Annex IV) Exclusion Criteria: Prior chemotherapy or radiotherapy, including neo-adjuvant treatment for cancer of the breast, Bilateral breast cancer or history of contralateral breast cancer Cardiac history: cardiac insufficiency (LVEF <50%) or coronary decompensation Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential) Inflammatory breast cancer Distant metastasis or supraclavicular adenopathy Benign pathology or history of malignant pathology accompanied by a life expectancy of less than two years Contra-indication to Anthracyclines, Cyclophosphamide, 5FU or Taxol Psychiatric pathology Patient participating in another trial

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

| Intervention/Treatment |
| --- |
|Procedure: 6 FEC 100|nan|
|Procedure: 4 FEC 100 followed by 4 Taxol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy

Study Overview
=================
Brief Summary
-----------------
To quantify rates of bleeding events and investigate the characteristics of prescribed patients, rates of bleeding events, persistence and healthcare resource utilization of Oral Anticoagulants (OACs) prescribed in routine clinical practice.

Official Title
-----------------
Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy

Conditions
-----------------
Anticoagulation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: are at least 18 years of age at index date Initiated new OAC therapy ( no previous prescriptions of the same index OAC in the last 12 months prior to the index date ) during the study period Had at least 1 claim with diagnosis of AF anytime in their records Exclusion Criteria: Have a record that is indicative of Valvular Atrial Fibrillation during this period Have a history of the OACs prescribed during the study period as assessed during the period of data availability(i.e. history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran or VKA) Have more than one OAC exposure which starts on the same date

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| High Dose Group<br>Apixaban - 10 mg/day Rivaroxaban - 20 mg/day Dabigatran - 300 mg/day | |
| Low Dose Group<br>Apixaban - 5 mg/day Rivaroxaban - 15 mg/day Dabigatran - 220 mg/day | |
| Other Dose Group<br>Invalid Doses / Off-Label | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of clinically relevant bleeding events among Non-valvular atrial fibrillation (NVAF) patients following treatment initiation on an oral OAC in Italy |  | Approximately 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of patient demographics at the time of OAC initiation |  | at baseline | 
| Distribution of clinical characteristics at the time of OAC initiation |  | at baseline | 
| Composite of number and percentage of patients who are persistent with their newly prescribed OAC |  | Approximately 30 months | 
| Incidence of major bleeding events following treatment initiation among NVAF patients following treatment initiation on an oral OAC in Italy |  | Approximately 30 months | 
| Composite of number and percentage of patients with major bleeding events, thromboembolic events, or death while exposed to the newly prescribed OAC |  | Approximately 30 months |
Schizophrenia Treatment Adherence Investigation (STAI)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this treatment review and feedback program is to quantify the risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia.

Detailed Description
-----------------
The primary objective of this treatment review and feedback program is to quantify the risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia. Observational study - no study drug administered

Official Title
-----------------
Clinical Audit and Feedback Program to Determine Risk for Medication Adherence in Outpatients Diagnosed With Schizophrenia in Australia

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Other: Risk status for medication adherence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV Currently treated in an outpatient clinic Able to provide informed consent Concurrent enrolment in clinical trials is acceptable Have completed all questions on the Drug Attitude Inventory (DAI-10) and Medication Adherence Rating Scale (MARS) survey Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| 001<br> | Other: Risk status for medication adherence<br>* Examination of risk status for medication adherence in a cohort of Australian patients diagnosed with schizophrenia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome measure is the Clinical Assessment of Adherence as rated by the Investigators |  | 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical exacerbations (worsening of symptoms) |  | 6 mths, 12 mths | 
| Medication changes |  | 6 mths, 12 mths | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment review, Schizophrenia, Observational, Prospective studies, Australia
Influence of Vitamin D on Inflammatory Bowel Disease Remission

Study Overview
=================
Brief Summary
-----------------
Vitamin D has been shown to influence a multitude of systems. We intend to see whether different types of Vitamin D supplements have an effect on inflammatory bowel disease.

Conditions
-----------------
Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D
* Other: Water or milk
* Dietary Supplement: Vitamin D enriched milk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate inflammatory bowel disease Exclusion Criteria: Hypersensitivity to milk products

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: Vitamin D<br> | Dietary Supplement: Vitamin D<br> <br> |
| Placebo Comparator: Placebo<br> | Other: Water or milk<br> <br> |
| Active Comparator: Unique vehicle for Vitamin D supplementation<br> | Dietary Supplement: Vitamin D enriched milk<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory disease remission |  | One year |
Physical Activity Referrals to the Community

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the impact of primary care referrals to community physical activity programs for overweight and obese youth aged 6-18 years on objectively measured physical activity and cardiorespiratory fitness, as well as other cardiovascular health indicators. We hypothesize that physical activity referrals will result in higher levels of physical activity and fitness.

Official Title
-----------------
Primary Care Physical Activity Referrals to the Community

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Behavioral: Physical activity referral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 6-18 years Body mass index greater than or equal to the 85th percentile for age and sex or greater than or equal to 25 for youth aged 18 Fluent in English Parent of participant must be fluent in either English or Spanish Exclusion Criteria: Medical conditions that preclude participation in physical activity

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Referral<br>Physical activity referral | Behavioral: Physical activity referral<br>* Provision of a primary care referral to at least one community-based physical activity program that is a good match for the participant's needs and preferences and patient follow-up on enrollment.<br>|
| No Intervention: Wait-list control<br>Wait-list controls receive no intervention until after they provide follow-up measurements. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in minutes per day of moderate-to-vigorous physical activity | Assessed via accelerometry | Baseline and at 8-11 weeks | 
| Change in cardiorespiratory fitness | Assessed via 3 minute step test | Baseline and at 10-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass index |  | Baseline and at 10-12 weeks | 
| Change in body composition |  | Baseline and at 10-12 weeks | 
| Change in blood pressure |  | Baseline and at 10-12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Pediatric Obesity, Physical Activity, Physical Fitness, Primary Health Care, Referral and Consultation
Second-Line Irinotecan or Gefitinib in Docetaxel Pretreated NSCLC

Study Overview
=================
Brief Summary
-----------------
To determine whether in docetaxel pretreated advanced NSCLC patients with favorable clinical parameter(s) gefitinib can produce different outcomes from patients without favorable clinical parameter treated with irinotecan.

Detailed Description
-----------------
It has been suggested that some clinical parameters, including women, no smoking history and a histologic diagnosis of adenocarcinoma, are associated with favorable outcomes of gefitinib therapy. We will conduct a phase II study in docetaxel pretreated advanced NSCLC patients treated with gefitinib or irinotecan according to these clinical parameters in order to determine whether in patients with favorable clinical parameter(s) gefitinib will produce difference outcomes from patients without favorable clinical parameter treated with irinotecan.

Official Title
-----------------
A Phase II Study of Second-Line Therapy With Irinotecan or Gefitinib in Docetaxel Pretreated Patients With Non-Small Cell Lung Cancer: a New Treatment Strategy According to Clinical Predictors for Response

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Gefitinib
* Drug: Irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 75 years or less histologically or cytologically confirmed non-small cell lung cancer advanced, metastatic or recurrent ECOG performance status 0 to 2 one prior palliative chemotherapy including docetaxel measurable or evaluable indicator lesion(s) normal marrow, hepatic and renal function provision of written informed consent Exclusion Criteria: active infection and/or severe comorbidities pregnant or breastfed women active CNS metastasis active bleeding in GI tract or elsewhere

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gefitinib|nan|
|Drug: Irinotecan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  |  | 
| Progression-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Toxicity |  |  |
Effect of a Physical-activity-promoting Environment on Motor Skills, Physical Activity and Quality of Life of Children in Childcare Settings

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effect of a project promoting unstructured spontaneous physical activity (PA) through an adaptation of the built environment and the provision of a supportive social environment of childcare centers on motor skills, physical activity, desire to move around, body mass index (BMI), quality of life and PA and behavior of the family.

Detailed Description
-----------------
The study will last one school year and includes 58 childcare centers in 3 provinces (JU, NE, VD) of the French part of Switzerland.

Official Title
-----------------
Effect of a Physical-activity-promoting Environment on Motor Skills, Physical Activity, Quality of Life and BMI of Children in Childcare Settings (Youp'là Bouge)

Conditions
-----------------
Obesity, Inactivity

Intervention / Treatment
-----------------
* Behavioral: Lifestyle intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children in selected childcare centers

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group: No intervention<br>No intervention, regular childcare program | |
| Experimental: Intervention group<br>Promoting unstructured spontaneous PA through an adaptation of the built environment and the provision of a supportive social environment | Behavioral: Lifestyle intervention<br>* Promoting unstructured spontaneous physical in childcare through an adaptation of the built environment and the provision of a supportive social environment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor skills |  | 1 school year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity |  | 1 school year | 
| Enjoyment of physical activity |  | 1 school year | 
| BMI |  | 1 school year | 
| Quality of life |  | 1 school year | 
| Physical activity and behavior of the family |  | 1 school year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Childhood obesity, Children, Inactivity, Physical activity, Motor skills, Motor fitness, Quality of life, Nutrition, Family
Pregabalin for Alcohol Dependence

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking and reducing drinking severity

Detailed Description
-----------------
This is a two cell double blind placebo controlled randomized clinical trial of pregabalin for alcohol dependence

Official Title
-----------------
Double Blind Placebo Controlled Randomized Clinical Trial of Pregabalin for Alcohol Dependence

Conditions
-----------------
Alcoholism

Intervention / Treatment
-----------------
* Drug: Pregabalin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alcohol Dependence by ICD-X criteria Exclusion Criteria: Severe co-morbid psychiatric and somatic diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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: pregabalin<br> | Drug: Pregabalin<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention in treatment | Number of subjects retianed in treatment (not relapsed) | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly alcohol consumption | Time Line Follow Back technique | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregabalin, patients, treatment