linjc16/ctgov huggingface dataset:
Questionnaires and Cognitive Assessments Following Mammography

Study Overview
=================
Brief Summary
-----------------
This pilot research trial studies how well questionnaires and cognitive assessments work in tracking patient symptoms following mammography. Gathering information over time through questionnaires and cognitive tests about symptoms patients may experience after a mammogram may help doctors understand the cause of these symptoms.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To determine the feasibility of Internet-based cognitive assessments as preliminary data prior to larger clinical trial. OUTLINE: Patients complete questionnaires and cognitive assessments over 45-60 minutes within 3 weeks following mammography and at about 3 months in patients for whom biopsy is not required, before biopsy and at about 3 months in patients for whom biopsy is required, and at 4-6 weeks after first chemotherapy infusion in patients receiving chemotherapy.

Official Title
-----------------
Symptom Tracking in Women Following Mammography

Conditions
-----------------
Health Status Unknown

Intervention / Treatment
-----------------
* Other: Cognitive Assessment
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mammography Breast Imaging Reporting and Data System (BI-RAD) 4-5; or BI-RAD 1-2 Fluent in English Access to Internet Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: Prior abnormal mammography Prior cancer diagnosis Prior treatment with chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (questionnaires, cognitive assessment)<br>Patients complete questionnaires and cognitive assessments over 45-60 minutes within 3 weeks following mammography and at about 3 months in patients for whom biopsy is not required, before biopsy and at about 3 months in patients for whom biopsy is required, and at 4-6 weeks after first chemotherapy infusion in patients receiving chemotherapy. | Other: Cognitive Assessment<br>* Complete cognitive assessments<br>Other: Questionnaire Administration<br>* Complete questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients invited who agree to participate | Number of patients invited will be reported. | Up to 2 years |
Bronchoscopic Closure of Bronchopleural Fistulas With Occlutech Figulla ASD N Occluder Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the feasibility of closing bronchopleural fistulas with devices originally developed for correction of cardiac septal defects deployed through bronchoscopic procedures.

Official Title
-----------------
Bronchoscopic Closure of Bronchopleural Fistulas With Occlutech Figulla ASD N Occluder Device

Conditions
-----------------
Bronchopleural Fistula

Intervention / Treatment
-----------------
* Device: Closure of bronchopleural fistula with Occlutech Figulla


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 14 years old Bronchopleural fistulas Exclusion Criteria: Clinical conditions increasing surgical risk (hemodynamic instability, respiratory distress) Immunosuppressed patients Acute intense inflammatory process in fistula edge Suppurative pleural cavity infection

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Occluder<br>The patients with bronchopleural fistulas treated with bronchoscopic deployment of the cardiac septal defects occluder. | Device: Closure of bronchopleural fistula with Occlutech Figulla<br>* Patients with bronchopleural fistulas will be submitted to a bronchoscopic procedure to deploy the cardiac septal defect occluder in the fistula traject.<br>* Other names: Bronchoscopic bronchopleural fistula closure with occluders;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of tracheobronchial fistulas with the Occlutech Figulla ASD N occluder | The closure of the fistulas will be bronchoscopically observed at regular intervals: one week, three weeks, two months and six months. At the third months post intervention, a thorax CT scan will ascertain the correct position and stability of the device. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchopleural fistula, Bronchoscopy
Post-Approval Study of the Guidant Carotid Stent Systems and Embolic Protection Systems: CAPTURE

Study Overview
=================
Brief Summary
-----------------
This purpose of this study is to collect data on the FDA-approved ACCULINK(TM) Carotid Stent System and FDA 510(k)-cleared ACCUNET(TM) Embolic Protection System for the treatment of patients with atherosclerotic disease, when used by physicians under commercial use conditions.

Detailed Description
-----------------
CAPTURE is a post-approval study to collect information on the safety and effectiveness of the ACCULINK and ACCUNET since the approval/clearance of these devices by the FDA. The ACCULINK stent is an elastic-like metal tube that is used to hold open a narrow part of a blood vessel. The ACCUNET is a wire mesh basket that is placed in the vessel to catch material (blood clots, fatty material) that could break off from the narrowed area of the blood vessel and block blood flow downstream during the stent procedure. Another goal of the CAPTURE study is to confirm that the ACCULINK and ACCUNET can be used safely by physicians with varying levels of experience in stenting procedures. The basis for FDA's approval/clearance of the ACCULINK and ACCUNET was the ARCHeR trials (ACCULINK/ACCUNET for Revascularization of Carotids in High-Risk Patients). The ARCHeR trials were conducted to collect data on the safety and effectiveness of the ACCULINK and ACCUNET when used in the treatment of carotid artery disease in patients at high risk for surgical treatment (carotid endarterectomy) because of medical or surgical comorbidities. The ARCHeR trials showed that the ACCULINK, used with or without the ACCUNET, is a safe and effective treatment option based on the rate of death, stroke, and myocardial infarction at 30 days, and stroke at one year.

Official Title
-----------------
Carotid RX ACCULINK(TM)/ACCUNET(TM) Post-Approval Trial to Uncover Unanticipated or Rare Events - CAPTURE

Conditions
-----------------
Atherosclerotic Disease, Carotid

Intervention / Treatment
-----------------
* Device: RX ACCULINK(TM) Carotid Stent System and RX ACCUNET(TM) Embolic Protection System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient's physician used an ACCULINK and/or ACCUNET
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: RX ACCULINK(TM) Carotid Stent System and RX ACCUNET(TM) Embolic Protection System|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death, stroke, and myocardial infarction at 30 days post-procedure. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atherosclerotic disease
Effect of Solution-Focused Support Program on Anxiety Levels of Parents During the COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
In this research, it was aimed to determine the anxiety levels of parents in the Covid-19 pandemic and to examine the effects of the Solution-Focused Support Program, which is planned to be given to parents with high anxiety levels.

Detailed Description
-----------------
The study is conducted with parents whose children aged 3-6 years, and have high anxiety levels. In collecting research data; an introductory information form prepared by researchers and the State-Trait Anxiety Inventory will be used.

Official Title
-----------------
Effect of Solution-Focused Support Program on Anxiety Levels of Parents With Children Aged 3-6 Years During the COVID-19 Pandemic

Conditions
-----------------
Anxiety, Parents, Covid19

Intervention / Treatment
-----------------
* Other: Solution-Focused Support Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents with children aged 3-6, Having internet at home or mobile phone, Parents who volunteer to participate in the study Exclusion Criteria: Having communication problems, Parents who have not attended at least one session

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Solution-Focused Support Program will apply to the participants. | Other: Solution-Focused Support Program<br>* All participants will be given a program of 4 sessions for 4 weeks. Each session is planned to last approximately 50 minutes.<br>|
| No Intervention: control group<br>No intervention will be applied to the parents in the control group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-Trait Anxiety Inventory (STAI) | STAI was developed by Spielberg et al. In 1970 to measure the trait and state anxiety levels of individuals and was adapted to Turkish by Öner and Le Compte (1983) (Gilik and Avşaroğlu 2017). There are a total of 40 questions in the State-Trait Anxiety Scale. The State Anxiety Sub-Scale (STAI-S) evaluates how an individual feels at a particular time and under certain conditions. The Trait Anxiety Subscale (STAI-T) generally assesses how an individual feels. The scores obtained from both scales vary between 20 and 80. High score indicates high anxiety level, low score indicates low anxiety level. | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, child, nursing practice, parents, Solution-Focused Support Program
The Effect of Ablation Therapy on Barrett's Esophagus

Study Overview
=================
Brief Summary
-----------------
To assess the effect of ablative therapy (Photodynamic Therapy or Radiofrequency ablation ) on Barrett's Esophagus

Detailed Description
-----------------
To assess the effect of ablation therapy on Barrett's esophagus. Proposal Ablation therapy is an FDA approved treatment to decrease cancer risk in Barrett's esophagus mucosa. This is being performed in our Barrett's Esophagus Unit on a regular basis. However, the longterm outcomes of this therapy is not established and there are patients who have been treated who later re-develop Barrett's mucosa. This study will allow us store tissue samples that can later be used to assess the effect of ablative therapy on Barrett's esophagus.

Official Title
-----------------
The Effect of Ablation Therapy on Barrett's Esophagus

Conditions
-----------------
Barrett's Esophagus, Early Esophageal Adenocarcinoma

Intervention / Treatment
-----------------
* Other: Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus with high grade dysplasia or early esophageal adenocarcinoma Ability to provide informed consent Exclusion Criteria: Eastern Cooperative Oncology Group performance status 3 or 4 Inability to tolerate endoscopic procedures Pregnancy: Females of child-bearing age will be screened with pregnancy test.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| 1<br>Patients with Barrett's Esophagus or early esophageal adenocarcinoma who will or have had ablation therapy will be enrolled in this long term follow up study | Other: Biopsy<br>* Biopsies for research purposes will be obtained when returning for clinically indicated surveillance of Barrett's Esophagus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment | presence of persistent or recurrence of barrett's esophagus and/or dysplasia | at time of surveillance intervals | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Photodynamic Therapy, Barrett's Esophagus, Early Esophageal Adenocarcinoma
Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology

Study Overview
=================
Brief Summary
-----------------
Fifteen cohorts will be opened. Each cohort will explore one analysis method and/or tumoral type. Up to 50 patient can be included into each cohort.

Official Title
-----------------
Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology

Conditions
-----------------
Solid Tumor.

Intervention / Treatment
-----------------
* Procedure: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or more Performance status from 0 to 4 Patient treated followed for histologically confirmed solid tumor type of any of these localization : breast, prostate, uterus, ovary, colon, lung, head and neck, melanoma. Informed consent form signed. Exclusion Criteria: Patient with history of other invasive cancer within 5 years. Patient treated for any non-invasive cancer Patient individually deprived of liberty or placed under the authority of a tutor Geographical condition potentially preventing compliance with the study protocol.

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 |
| --- |
|Procedure: Blood sampling|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTC, CEC or ctDNA incidence | number of CTC or CEC in 7.5ml of blood | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTC and CEC molecular characterization | This outcome is self-explanatory. | 3 years | 
| Circulating tumor DNA (ctDNA) detection and quantification | plasma mutation detection (number of copy) | 3 years |
Preparation Rich in Growth Factors (PRGF) Treatment for Osteoarthritis of the Knee

Study Overview
=================
Brief Summary
-----------------
to evaluate the influence of PRGF treatment on patient suffering from OA knee

Detailed Description
-----------------
Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in osteoarthritis (OA) capsular joints via multiple mechanisms. Our aim is to examine the effect of a platelet-derived preparation rich in growth factors (PRGFs) in OA knee

Official Title
-----------------
PRP as a Treatment for Knee Osteoarthritis - Randomized-double-blind-placebo Control Trail.

Conditions
-----------------
Osteoarthritis of the Knee

Intervention / Treatment
-----------------
* Biological: PRGF
* Drug: hyaluronic acid
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 40-75 years old diagnosed Oa of the knee more then 1 year no knee deformation Exclusion Criteria: mental of physical disabilities pregnancy deformities of the knee

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: PRGF<br>* intra auricular injection 6mg<br>* Other names: platelet-derived preparation rich in growth factors;|
| Active Comparator: 2<br> | Drug: hyaluronic acid<br>* 20 mg / 2 ml<br>* Other names: Arthrease;|
| Placebo Comparator: 3<br> | Drug: placebo<br>* physiological water 3cc + lidocain 3cc<br>* Other names: seline 0.9% nacl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvment of symptomes |  | 1 year |
Randomized Clinical Trial of 8 Weeks Pulmonary Rehabilitation in Advanced Stage Lung Cancer Patients With COPD During Cytotoxic Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Pulmonary rehabilitation might be benificial in advanced lung cancer patients with COPD who undergo cytotoxic chemotherapy. We will compare two groups, 8 week pulmonary rehabilitation group and usual care group.

Conditions
-----------------
COPD, Lung Cancer

Intervention / Treatment
-----------------
* Behavioral: pulmonary rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologically proven lung cancer chronic obstructive pulmonary disease age > 20 ECOG 0-1 cytotoxic chemotherapy Exclusion Criteria: other history of cancer within 5 years other major disease associated with heart, lung, neurology, mental and metabolic disorders osteolytic bone metastatis to weight bearing site uncontrolled infection

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| No Intervention: control<br>stretching exercise | |
| Experimental: pulmonary rehablitation<br>warming up exercise strengthening exercise aerobic exercise cool down | Behavioral: pulmonary rehabilitation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference of VO2 max | difference maximal oxygen consumption during exercise cardiopulmonary test between before and after intervention/control | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference of Saint George's Respiratory Questionannaire (SGRQ) score | the difference of SGRQ score | 8 weeks | 
| difference of pulmonary function test | the difference of FVC and FEV1 | 8 weeks | 
| difference of 6 min walk test | the difference of 6 minute walk test | 8 weeks | 
| difference of depression test | using Hospital Anxiety and Depression scale (HADS), measure the difference HADS between before and after intervention/control | 8 weeks |
Effectiveness of Clozapine Versus Olanzapine for Treatment-resistant Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study will determine the effectiveness of clozapine versus olanzapine in treating people with schizophrenia that has not improved with treatment.

Detailed Description
-----------------
This is a two-year open-label, randomized trial of the comparative effectiveness of clozapine versus olanzapine in patients with treatment refractory schizophrenia. The objective is to determine whether in a naturalistic setting olanzapine is a logical treatment choice (before using the more toxic clozapine) for some treatment refractory patients.

Official Title
-----------------
Clozapine vs. Olanzapine: An Effectiveness Study

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Clozapine
* Drug: Olanzapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-60 years; Diagnosis of treatment refractory schizophrenia or schizoaffective disorder; BPRS score > 21 (0-6) scale; Either two 6-8 week trials of typical neuroleptics given at a dosage of 600 mg/day of CPZ or its equivalent or one 6-8 week trial of an atypical antipsychotic at a reasonable dose (i.e. risperidone 4-6 mg/day); The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent; Clinically appropriate for clozapine or olanzapine Exclusion Criteria: Current substance abuse; Suicide or homicide risk; Pregnancy or lactation; History of seizures or blood dyscrasias

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clozapine<br>Clozapine or olanzapine in treatment resistant schizophrenia | Drug: Clozapine<br> <br> |
| Active Comparator: olanzapine<br>clozapine or olanzapine in treatment resistant schizophrenia | Drug: Olanzapine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in quality of life. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom measures, neurological side effects, neuropsychological performance, patient satisfaction and burden on the family. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clozapine, olanzapine