linjc16/ctgov huggingface dataset:
Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder in Individuals With Severe Mental Illness

Study Overview
=================
Brief Summary
-----------------
This study will develop a cognitive behavioral therapy (CBT) program to treat symptoms of post-traumatic stress disorder (PTSD) in people with severe mental illnesses who are treated within community mental health systems.

Detailed Description
-----------------
A significant proportion of people with SMI who are treated within the public sector also suffer from PTSD. Evidence suggests that these individuals often receive inadequate mental health services because effective treatments have not been explored. This study will develop and implement a CBT treatment that is designed specifically for the SMI/PTSD population. In the first year of the study, a treatment manual and a CBT treatment model, including education, social skills training, and exposure therapy, will be developed. In the following two years, the treatment program will be tested in individuals with SMI and PTSD. Scale ratings, self-report checklists, and daily logs of behavior will be used to assess PTSD symptoms. Scale ratings and self-report surveys will also be used to measure hostility, functional status, depression and schizophrenia symptoms, and satisfaction with the study. Assessments will be made throughout the study.

Official Title
-----------------
CBT for PTSD and SMI in Community Mental Health Centers

Conditions
-----------------
Stress Disorders, Post-Traumatic, Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy (CBT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PTSD and schizophrenia or schizoaffective disorder Active involvement in case management Exclusion Criteria: Suicide 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cognitive Behavioral Therapy (CBT)|nan|

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
-----------------
Psychotic Disorders
Silver Nitrate Application and Topical Corticosteroids for Hypergranulation Tissue

Study Overview
=================
Brief Summary
-----------------
This protocol describes a randomized, two arm clinical trial comparing two topical treatments in patients with hypergranulation tissue at gastrostomy tube sites. The subjects are randomized to either group 1or group 2 treatments: Maximum duration of therapy is 4 weeks. However, the therapy may be discontinued anytime at the discretion of the investigator or if there is resolution of the of the hypergranulation tissue.

Official Title
-----------------
Randomized Clinical Trial Comparing Silver Nitrate Application With Topical Corticosteroids for Hypergranulation Tissue at Gastrostomy Sites

Conditions
-----------------
Hypergranulation Tissue; Gastrostomy Tube Site

Intervention / Treatment
-----------------
* Drug: Silver Nitrate
* Drug: Triamcinolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients <18 Evaluated for hypergranulation at the G-tube site Inpatient and out-patient Exclusion Criteria: Children not meeting the above criteia

Ages Eligible for Study
-----------------
Maximum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Silver nitrate treatment will include weekly applications in the pediatric surgery office by a clinician. | Drug: Silver Nitrate<br>* Silver Nitrate Sticks<br>|
| Active Comparator: Group 2<br>Triamcinolone cream, 0.5% applied three times per day by the patient's caregiver. | Drug: Triamcinolone<br>* 0.5% cream<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal reduction in granulation tissue |  | During maximum of 4 weeks of therapy |
Sevoflurane-Remifentanil Anaesthesia. The Risk of Post Operative Nausea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia concerning post- operative nausea and vomiting.

Detailed Description
-----------------
Propofol and sevoflurane anaesthesia are used world wide at the anaesthetists discretion. Propofol is superior to inhalational anaesthetics as anaesthesia for patients at risk of post operative nausea and vomiting (PONV) as PONV is diminished. However, when remifentanil is used as adjuvant to sevoflurane, the total dose of the latter is reduced. Therefore, we wanted to investigate if sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia with emphasis on nausea, vomiting and total PONV during 24 hours. In the post anaesthesia care unit (PACU) and in the surgical ward nausea was scored on a visual analogue score. Vomiting was registered.

Official Title
-----------------
Postoperative Nausea and Vomiting Are Similar When Propofol or Sevoflurane Are Used as Adjuvant to Remifentanil During Anaesthesia for Gynaecological Surgery

Conditions
-----------------
Nausea, Vomiting

Intervention / Treatment
-----------------
* Procedure: Sevoflurane-remifentanil anaesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females younger than 50 years ASA I-II Scheduled to gynaecological laparotomies or laparoscopies Exclusion Criteria: Medication known to act anti-emetic ASA status greater than II Malignant hyperthermia Allergy to the drugs used.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Sevoflurane-remifentanil anaesthesia|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea, incidence and intensity ( VAS score )in PACU and surgical ward |  |  | 
| Vomiting, incidence in PACU and surgical ward |  |  | 
| Total PONV after 24 hours |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nausea, Vomiting, Post operative, Propofol remifentanil anaesthesia, Sevoflurane remifentanil anaesthesia
Registry On Efficacy and Safety Of Rosuvastatin, and Atorvastatin and Simvastatin In Hypercholesterolaemia

Study Overview
=================
Brief Summary
-----------------
The objective of this follow-up retrospective study is to evaluate the long term efficacy and safety of rosuvastatin in reducing lipid parameters in clinical practice.

Official Title
-----------------
A Registry to Collect Data of Efficacy and Safety Between Rosuvastatin, and Atorvastatin and Simvastatin In Subjects With Type IIa and IIb Hypercholesterolaemia Under Real Clinical Settings

Conditions
-----------------
Hypercholesterolaemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary hypercholesterolemia Subjects from first rosuvastatin Registry 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who maintain US NCEP ATP III LDL-C target goals after long-term therapy |  | Up to 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-cholesterol levels |  | Up to 8 years | 
| HDL-cholesterol levels |  | Up to 8 years | 
| Proportion of patients having raised levels of serum CK or ALT |  | Up to 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholesterol, rosuvastatin, retrospective
Comparative Bioavailability in Healthy Elderly Volunteers

Study Overview
=================
Brief Summary
-----------------
A randomised four way crossover design in which each subject will receive two dose levels of TRx-0037 and two doses of TRx-0014 over approximately a four week period in randomised order.

Official Title
-----------------
Comparative Bioavailability of TRx0037 and TRx0014 in Healthy Elderly Volunteers

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: TRx0037


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female 55 and over No clinically important abnormal physical finding No clinically significant lab results Normal ECG, Normal BP and HR,BMI between 19 and 32 Weight 50 to 100 kg, Able to communicate Provide written informed consent Non smokers Males to use contraception Females to be surgically sterile or post menopausal Exclusion Criteria: Administration of any IMP other than study drug within 12 weeks before entry Use of any prescribed meds, St John's wort, over the counter meds as described in the protocol Surgical or medical condition that might interfere with IMP History of drug or alcohol abuse Clinically significant allergy requiring treatment Loss of greater than 400ml of blood within 12 weeks. Serious adverse reaction or hypersensitivity to any drug Prescence of Hep B, Hep c or HIV-1 or HIV-2 at screening Presence of G6PD at screening History of methaemoglobinaemia Partner who is pregnant of lactating Positive Pregnancy test

Ages Eligible for Study
-----------------
Minimum 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRx0037<br> | Drug: TRx0037<br> <br> |
| Active Comparator: TRx0014<br> | Drug: TRx0037<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative bioavailability | Investigate the relative bioavailability of TRx0037 and TRx0014 at two molar equivalent doses in healthy elderly male and female (post-menopausal/non-childbearing) subjects |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability and pharmacokinetics | Safety, tolerability and pharmacokinetic (PK) evaluations of the two dose levels of TRx0037 and TRx0014. |  |
Patients Returning to Work After Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
The literature is quite rich concerning the factors which influence the return to work after acute coronary syndrome. They can be divided into three categories: factors linked to the patient, those linked to the workstation and factors linked to an external intervention. A study published in 1992 evaluated a set of predictive factors for recovery one year after acute coronary syndrome and showed that the proportion of clinical factors accounted for 20%, functional factors for 27% but above all socio-economic factors for 45. %. On the other hand, there are only a few studies that are interested in the return to work after acute coronary syndrome according to the management in occupational medicine, and in particular the realization or not of a pre-return visit. The results of a survey published in 2016 show that the recommendations made during the return visit were significantly different depending on whether or not there was a pre-return visit and concerned all types of pathology. In view of all of these elements, it seems important to the investigators to study the expected benefit of an early orientation towards occupational medicine via the pre-return visit, and to study the factors delaying or favoring the return to work. .

Official Title
-----------------
Patients Returning to Work After Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age ≥18 years old In professional activity during acute coronary syndrome (employee, civil servant, self-employed or looking for a job) -Mastering the French language (knowing how to read and write French) Agreeing to participate in the study and not having expressed his opposition to the reuse of his data for the purposes of this research Exclusion criteria: Subject having expressed opposition to participating in the study Inability to provide informed information about the subject (subject in an emergency situation, difficulty in understanding the subject, etc.) Subject under safeguard of justice Subject under guardianship or guardianship

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of the contribution of the pre-return visit to the return to work after acute coronary syndrome |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Coronary Syndrome, ACS, Return to work, Occupational health, Cardiology, Intensive-care unit
Non-interventional Study, Long Term Treatment on Glabellar Lines With Dysport® in Subjects of Chinese Origin

Study Overview
=================
Brief Summary
-----------------
This is a prospective, longitudinal, non-interventional, multi-center study to collect subject and physician satisfaction, and treatment experience with Dysport in real clinical practice in subjects of Chinese origin.

Detailed Description
-----------------
Approximately 250 subjects are planned to be included in the study.

Official Title
-----------------
A Prospective, Non-interventional Study to Collect Subject and Physician Satisfaction During Long Term Treatment of Glabellar Lines With Dysport® in Subjects of Chinese Origin in Real Clinical Practice

Conditions
-----------------
Glabellar Lines

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male or female up to 65 years of age, and of Chinese origin. Moderate (grade 2) or severe (grade 3) glabellar lines at max frown. Prior to and independent of study, subject is seeking long term treatment of their glabellar lines. Prior to and independent of the study participation, physician intended to treat the subject with Dysport. Time and ability to complete the study and comply with instructions. Understands the study requirements and signed the informed consent form (ICF) Exclusion Criteria: Hypersensitive to Dysport or its excipients. Presence of contraindications to Dysport treatment as specified in the approved leaflet in China. Subject is at risk for precautions, warnings, and/or contraindications to Dysport as specified in the approved leaflet in China.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Subject satisfaction assessed by Subject Satisfaction Questionnaire | At Visit 6 (i.e., three weeks, after the 3rd injection) subjects will be asked What is your overall satisfaction after three treatment cycles? Response options: Very Satisfied Satisfied Dissatisfied Very Dissatisfied The primary endpoint will evaluate the proportion of subjects in each response category | 3 weeks after 3rd injection |
Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily. The study duration consists of a baseline period (4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

Official Title
-----------------
A Confirmatory Study of APTA-2217 in Patients With Chronic Obstructive Pulmonary Disease (A Placebo-controlled Double-blind Comparative Study)

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Drug: Roflumilast


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion criteria: Patients with chronic obstructive pulmonary disease Current smoker or ex-smoker 30 to 80% of predicted FEV1 after inhalation of short acting beta stimulant Main exclusion criteria: Patients with poorly controlled COPD Patients who need for long-term oxygen therapy Patients who have concurrent respiratory diseases such as asthma, diffuse panbronchiolitis, congenital sinobronchial syndrome, bronchiolitis obliterans, bronchiectasis, active tuberculosis, pneumoconiosis, pulmonary lymph vascular myoma, which are considered to affect the evaluation

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

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

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: Roflumilast|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in lung function parameters (post-bronchodilator). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function test, COPD symptoms, rescue medication, evaluation of QOL, COPD exacerbation, adverse events, pharmacokinetics. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Phosphodiesterase 4 inhibitor, Roflumilast
A Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy and safety/tolerability of 4 doses of Imeglimin versus placebo. The study will be performed in subjects with type 2 diabetes either naive of treatment or previously treated with an oral monotherapy excluding thiazolidinedione.

Official Title
-----------------
A Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes Mellitus.

Conditions
-----------------
Type 2 Diabetes Mellitus

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has given written informed consent Male and female type 2 diabetic subjects, either naïve of antidiabetic agents or treated with an oral anti-diabetic monotherapy. Body mass index (BMI) : ≥ 24 to ≤ 40 kg/m² HbA1c criteria: ≥ 7% and ≤ 9.5% Creatinine clearance ≥ 50 mL/[min*1.73 m2] at Screening Visit Effective contraception for women of child bearing potential Exclusion Criteria: Any disease which in the investigator's opinion would exclude the subject from the study Acute cardiovascular event within 3 months before randomization Uncontrolled high blood pressure Impairment of hepatic function History of drug-induced Torsades de Pointes or a marked baseline prolongation of the QTc interval Pregnancy or lactation Use of any non-permitted medication Positive screen for viral hepatitis

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: Imeglimin (Dose 1)<br> | Drug: Imeglimin<br> <br> |
| Experimental: Imeglimin (Dose 2)<br> | Drug: Imeglimin<br> <br> |
| Experimental: Imeglimin (Dose 3)<br> | Drug: Imeglimin<br> <br> |
| Experimental: Imeglimin (Dose 4)<br> | Drug: Imeglimin<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | Baseline and week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be assessed by the incidence of adverse events (AEs), physical examination, relevant changes on laboratory tests, vital signs, and 12-lead electrocardiograms (ECG) |  | Baseline to week 24 |