linjc16/ctgov huggingface dataset:
Treatment of Schizophrenia Through Internet-Based Psychoeducation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of a Web-based psychoeducational program in helping people with schizophrenia and their families manage the disease.

Detailed Description
-----------------
This study will provide a comprehensive psychoeducational program which includes education, social support, information, coping strategies, and guidance from mental health, social services, and medical professionals. This study will work to reduce relapse, facilitate patient rehabilitation, decrease family distress, and improve family well being. Patients and their families participate in an in-person Psychoeducational Survival Skills Workshop that is designed to provide patients and their families with basic information about schizophrenia and its treatment. After the workshop, participants are provided with 6 Web-based modules that are designed to increase mental health and schizophrenia knowledge. Patient relapse, family distress, family knowledge of schizophrenia, and data on user's acceptance and utilization are measured to determine the intervention's effectiveness.

Official Title
-----------------
Schizophrenia Patient and Family Continuity of Care

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

Intervention / Treatment
-----------------
* Procedure: World Wide Web-Based Psychoeducation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria DSM-IV diagnosis of schizophrenia or schizoaffective disorder At least 4 hours/week in-person contact with a family member Primary caregiver with a telephone Patient and primary caregiver speak and read English Exclusion Criteria: Enrolled in another clinical trial Evidence of organic brain syndrome Current alcohol or substance abuse that could explain the presenting index psychotic episode DSM-IV diagnosis of psychoactive substance dependency

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 55 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: World Wide Web-Based Psychoeducation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
NT-proBNP for Evaluation of the Dyspneic Patient in the Emergency Room and the Medical Ward

Study Overview
=================
Brief Summary
-----------------
The proposed study intends to evaluate the impact of the NT-proBNP assay on the diagnosis of heart failure in patients with dyspnea of unknown etiology presenting to the emergency room and admitted to the medical wards.

Detailed Description
-----------------
The proposed study intends to evaluate the impact of the NT-proBNP assay on the diagnosis of heart failure in patients with dyspnea of unknown etiology presenting to the emergency room and admitted to the medical wards. Patients will be consented and randomized to open or blinded NT-proBNP test performed within 90 minutes in a venous blood sample. Evaluation of the ER diagnosis and final discharge diagnosis in admitted patients will be carried out in light of the NT-proBNP results.

Official Title
-----------------
NT-proBNP for Evaluation of the Dyspneic Patient in the Emergency Room and the Medical Ward (BNP4EVER)

Conditions
-----------------
Acute Exacerbation, Shortness of Breath

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute shortness of breath of unknown etiology as presentation to the emergency room Possible acute exacerbation of known heart failure 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?
-----------------
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
-----------------
NT-proBNP, Heart failure, Dyspnea
Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in Elderly Adults

Study Overview
=================
Brief Summary
-----------------
Since influenza vaccines are normally administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profiles of the adjuvanted influenza vaccine need to be re-evaluated after repeated vaccine administration. In this study, subjects enrolled in a previous study will receive a booster dose with the 2006-2007 season's formulations of Fluarix or the adjuvanted vaccine.

Official Title
-----------------
Evaluate Reactogenicity & Immunogenicity of Adjuvanted Influenza Vaccine in Elderly Adults Previously Vaccinated With the Same Candidate Vaccine. Fluarix™ Administered in Young & Elderly Adults Will be Used as Reference

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Fluarix
* Biological: adjuvanted influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subjects must be healthy adults ages 18-40 years or >/= 65 years previously vaccinated with either Fluarix or the adjuvanted vaccine. Exclusion Criteria: Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immune modifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination Have a history of influenza infection since previous vaccination Women who are pregnant Subjects who have an acute or chronic clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Fluarix|nan|
|Biological: adjuvanted influenza vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the safety and reactogenicity of repeated vaccination with adjuvanted influenza vaccine during the 21 days following administration of the vaccine |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the humoral immune response and cell-mediated immune response 21 days after revaccination with candidate vaccine |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza,, improved vaccine,, influenza disease, elderly
Post Operative Quality of Life After Patulous Eustachian Tube Treatment

Study Overview
=================
Brief Summary
-----------------
Patulous eustachian tube (ET) is a usually asymptomatic poorly known ET pathology. When it becomes so and thus impairs the eardrum (retraction pockets, cholesteatoma) or patients' quality of life (QoL), therapeutic management is proposed. The surgical treatment has diversified in recent years but remains dominated by filling spaces around the ET (autologous fat and/or septal cartilage grafting). Efficiency is traditionally objectivized by dynamic otoscopy, tubomanometry and audiometry, but QoL must also be taken into account and its postoperative assesment was the objective of this work. Materials and Methods This is a unicentric retrospective study conducted from November 2016 to March 2019 on all patients with a disabling patulous ET, single or bilateral, managed surgically by autologous fat and/or septal cartilage grafting in investigators ENT department. Patients for whom a concomitant procedure was performed were excluded from the study. The post-operative QoL assessment was performed using the Glasgow Benefit Inventory (GBI), postoperative self-administered questionnaire validated in ENT, including a general, physical and social evaluation. Predictive factors for QoL improvement were investigated among pre-, per- and post-operative clinical data.

Official Title
-----------------
Post Operative Quality of Life Assesment After Patulous Eustachian Tube Surgical Treatment

Conditions
-----------------
Eustachian Tube Patulous

Intervention / Treatment
-----------------
* Other: Quality of life survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any surgically treateble patient with a unilateral patuluos eustachian tube Exclusion Criteria: any patient for whom an other surgical step than the eustachian tube one was needed, bilateral desease ,cholesteatoma
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Quality of life survey|Unilateral patulous eustachian tube surgically treated were interviewed about our life's quality by a survey|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative quality of life | glasgow benefit inventory : Post-operative quality of life score concerning general, social, and physical aspects  studied in 18 questions. A likert scale ranging from -2 to +2 (5 points) evaluate each of 18 points. Positive and higher score mean a better outcome (maximum = 36). Negative and lower score mean a wors outcome (minimum = -36). | quality of life score in beetwen 2 and 12 month postoperatively |
Safety and Efficacy of Inhaled Interferon Gamma-1b in Pulmonary MAC Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to test the safety and effectiveness of inhaled Interferon gamma-1b (IFN-g 1b), when administered for 48 weeks and in combination with oral antibiotics which may be administered for up to 72 weeks for the treatment of a lung infection caused by a bacterium called Mycobacterium avium complex . FDA has not approved Interferon gamma-1b for use in patients with MAC infection of the lungs, which is the purpose of this study.Interferon gamma-1b and similar proteins play important roles in establishing and maintaining protective immune responses against a variety of microorganisms.

Detailed Description
-----------------
Laboratory research has shown that a mouse form of interferon gamma is effective in treating mice with infections caused by bacteria similar to MAC as well as MAC infection.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Safety and Efficacy of Inhaled Interferon Gamma-1b With Antimycobacterials in Previously Treated or Mod-to-Sev Pulmonary Mycobacterium Avium Complex Infection

Conditions
-----------------
Lung Infection

Intervention / Treatment
-----------------
* Drug: interferon gamma-1b


Participation Criteria
=================
Eligibility Criteria
-----------------
Male and female patients, 18 years of age or older, with bacteriologically and radiographically confirmed pulmonary MAC infection who have been treated for their infection for at least 6 months within the previous 2 years, as well as patients with moderate or severe pulmonary disease due to MAC, not previously treated for this infection. Patients with recurrent pulmonary MAC infection after previous successful treatment for pulmonary MAC disease are also eligible. In addition, various laboratory testing must confirm conditions. Patients cannot be positive for HIV or have an extra-pulmonary (in general, outside of the lungs) infection of MAC. Other preconditions related to health or other conditions exist as factors for inclusion or exclusion from this study.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: interferon gamma-1b|500 mcg, oral, three times weekly|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sustained culture conversion |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary, mycobacterium avium complex infection, MAC, nontuberculous, mycobacteria, lung
Genetic and Environmental Risk Factors Related to Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Gathering information about genes, cigarette smoking, and diet may help doctors learn more about risk factors that may cause esophageal cancer. PURPOSE: This clinical trial is studying genetic and environmental risk factors related to esophageal cancer.

Detailed Description
-----------------
OBJECTIVES: Examine the role of several genetically-determined factors in combination with cigarette smoking and diet in the etiology and prevention of esophageal cancer. Identify polymorphisms in metabolizing enzymes (e.g., phase I or II metabolism [GSTM1, GSTT1,CYP1A1, CYP3A5, mEH, NQO1, GSTP1], DNA repair [XRCC1, ERCC2], free-radical formation [MPO, MnSOD], inflammatory genes [ IL1-beta], metastatic potential [MMP1], and cell cycle or tumor suppression [p21, p53]) and related path genes of susceptibility for esophageal cancer. OUTLINE: Blood and tumor tissue samples are collected. DNA purified from these samples is analyzed using DNA-based assays to determine polymorphisms in various related gene pathways. Patients complete questionnaires concerning environmental, smoking and diet habits. PROJECTED ACCRUAL: A total of 1,000 tissue samples from patients and healthy participants (750 patients and 250 healthy participants) will be accrued for this study.

Official Title
-----------------
Molecular Epidemiology of Esophageal Cancer: Pilot Project

Conditions
-----------------
Esophageal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Diagnosis of esophageal cancer (patient) Newly diagnosed disease Receiving care at Massachusetts General Hospital, Thoracic Oncology Center Friend or spouse of patient (healthy participants) PATIENT CHARACTERISTICS: No concurrent psychiatric incapacity or dementia PRIOR CONCURRENT THERAPY: Not specified

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polymorphisms in various pathways, DNA repair, free-radical formation, inflammatory genes, metastatic potential, and cell cycle or tumor suppression in blood samples |  | 2000-2016 | 
| Comparison of presence or absence of variant polymorphisms between cases and controls |  | 2000-2016 | 
| Correlation between polymorphisms in blood samples and polymorphisms in tissue specimens |  | 2000-2016 | 
| Analyses of dietary factors and Helicobacter pylori infection (previous vs current) |  | 2000-2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage 0 esophageal cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer
Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP

Study Overview
=================
Brief Summary
-----------------
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

Detailed Description
-----------------
This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immunogenicity of imsidolimab in subjects with GPP.

Official Title
-----------------
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

Conditions
-----------------
Generalized Pustular Psoriasis

Intervention / Treatment
-----------------
* Drug: Imsidolimab high dose
* Drug: Imsidolimab low dose
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Subject has a BSA affected with pustules (excluding palms and soles) ≥ 5%, a GPPPGA score ≥ 3 (moderate severity), and a PRS score ≥ 3 (moderate severity) at Day 1 Exclusion Criteria: Subject has other form of psoriasis excluding psoriasis vulgaris Subject flare is so severe that patient's life is at risk

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: IV high dose Imsidolimab, other name ANB019<br>ANB019 Biological Humanized Monoclonal Antibody High Dose | Drug: Imsidolimab high dose<br>* intravenous<br>* Other names: ANB019;|
| Experimental: IV low dose Imsidolimab, other name ANB019<br>ANB019 Biological Humanized Monoclonal Antibody Low Dose | Drug: Imsidolimab low dose<br>* intravenous<br>* Other names: ANB019;|
| Placebo Comparator: IV Placebo<br>Placebo Solution | Other: Placebo<br>* intravenous<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving Generalized Pustular Psoriasis Physician's Global Assessment (GPPPGA) score of 0 (clear) or 1 (almost clear) | Baseline to 0 (clear) or 1 (almost clear) | week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IL-36 Receptor, Interleukin 36, Imsidolimab
Evaluation of Predictive Factors for Psoas Tendinitis After First-line Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Evaluation of predictive factors for psoas tendinitis after first-line total hip arthroplasty. A single-centre retrospective study of medical data from the medical records of patients undergoing total hip arthroplasty.

Detailed Description
-----------------
From the medical records of a series of patients operated on for total hip arthroplasty: Main objective: To assess individual and surgical factors associated with the development of psoas tendinitis. Secondary objectives: To describe the frequency of occurrence of psoas tendinitis To describe the outcome of patients who underwent tenotomy.

Official Title
-----------------
Evaluation of Predictive Factors for Psoas Tendinitis After First-line Total Hip Arthroplasty

Conditions
-----------------
Psoas Tendinitis

Intervention / Treatment
-----------------
* Other: Cohort


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18 years or older, having been informed of the research Patient who has had a total hip replacement implanted for at least six months as a first-line treatment Patient who has been regularly monitored since the operation and for whom all clinical and radiological data are available during follow-up visits Exclusion Criteria: Patient undergoing revision surgery Patient who has indicated his opposition to the use of his medical data Patient under legal protection, guardianship or curators

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br>Simple cohort | Other: Cohort<br>* Cohort<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoas tendinitis development | Pain remission after tenotomy. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoas tendinitis occurrence frequency | Frequency of occurrence of psoas tendinitis | 6 months | 
| To describe the outcome of patients who have undergone tenotomy | To describe the outcome of patients who have undergone tenotomy | 6 months |