linjc16/ctgov huggingface dataset:
Bromfenac Sodium Hydrate Eye Drops in Familial Exudative Vitreoretinopathy

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the efficacy and safety of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.

Detailed Description
-----------------
This study aims to evaluate the presence of macular edema as the primary measure and the presence of conjunctival injection as the secondary measure for the investigation of the efficacy of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.

Official Title
-----------------
Efficacy of Bromfenac Sodium Hydrate Eye Drops in Children With Familial Exudative Vitreoretinopathy After Diode Laser Photocoagulation

Conditions
-----------------
Familial Exudative Vitreoretinopathies

Intervention / Treatment
-----------------
* Drug: Bromfenac Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed patients with familial exudative vitreoretinopathy Needing diode laser photocoagulation Consent to the study Exclusion Criteria: History of corneal diseases History of hypersensitivity to bromfenac sodium History of hypersensitivity to non-steroidal anti-inflammatory drugs Progressive ocular infection Liver diseases Hypersensitivity to sulfur dioxide Receiving anti-coagulation drugs History of coagulopathies

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 7 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bromfenac sodium hydrate eye drops<br>The patients will receive bromfenac sodium hydrate eye drops twice daily for 14 days. | Drug: Bromfenac Sodium<br>* The study participants will receive bromfenac sodium hydrate eyedrops twice daily for 14 days.<br>* Other names: Bronuck;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular edema response rate | Presence of macular edema | 4 weeks after the diode laser photocoagulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival injection response rate | Presence of conjunctival injection | 4 weeks after the diode laser photocoagulation |
Exercise and Diet Program for Schizophrenia Patients Who Are Taking Atypical Antipsychotic Medications

Study Overview
=================
Brief Summary
-----------------
In this study the investigators will recruit patients with the diagnosis of schizophrenia that are taking atypical neuroleptics and that are willing to participate in an exercise and diet program. The investigators will measure weight and abdomen circumference.

Official Title
-----------------
Exercise and Diet Program for Schizophrenia Patients Who Are Taking Atypical Antipsychotic Medications

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

Intervention / Treatment
-----------------
* Behavioral: Exercise program
* Behavioral: Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia Atypical neuroleptics Exclusion Criteria: Medical illness preventing exercise

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exercise and Diet program<br>All patients recruited in the study, participated in an homogeneous exercise program and diet. | Behavioral: Exercise program<br>* Homogenous exercise program in local fitness centers<br>Behavioral: Diet<br>* Weigh loss diet program prescribed by a professional nutritionist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | The weight of the participants of the trial was monitored during the trial, while they were following the exercise program and the diet, starting from the baseline until end of study/early withdrawal. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdomen circumference | The circumference of the abdomen of the participants of the trial was monitored during the trial, while they were following the exercise program and the diet, starting from the baseline until end of study/early withdrawal. | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, weight gain, atypical neuroleptics
31P-MRS and Huntington Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify and quantify a brain energy deficit in Huntington patients, using 31P-RMN spectroscopy.

Official Title
-----------------
31Phosphorus-Magnetic Resonance Spectroscopy and Huntington Disease

Conditions
-----------------
Huntington Disease

Intervention / Treatment
-----------------
* Other: 31P-MR spectroscopy
* Other: 31P-RMN spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 5<UHDRS<50 Age>18 years Ability to undergo MR scanning Covered by french social security Exclusion Criteria: Evidence of psychiatric disorder Attendant neurological disorder Contraindications to MRI (claustrophobia, metallic or material implants) Severe head injury Unable to understand the protocol Pregnancy Failure to give informed consent Subjects with exclusion criteria required by french law (e.g. subjects who require a legally authorized representative to obtain consent) Unwillingness to be informed in case of abnormal MRI

Ages Eligible for Study
-----------------
Minimum 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy volunteers<br> | Other: 31P-MR spectroscopy<br>* Brain energy deficit is quantified using 31P-MR spectroscopy<br>|
| Other: Huntington patients<br> | Other: 31P-RMN spectroscopy<br>* Brain energy deficit is quantified using 31P-RMN spectroscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain energy deficit in Huntington patients | 31P-MRS allows quantification of high-energy phosphate metabolites such as ATP and phosphocreatine. Objective: to look at brain energy metabolism during rest and activation. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlating a brain energy deficit with (i) biochemical parameters and (ii) clinical parameters in Huntington patients | Biochemical parameters include metabolites that we previously showed to be biomarkers in HD: branched chain amino acids and IGF1. Clinical parameters include UHDRS and TFC. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Energy, Metabolism, Spectroscopy
A 10-12 Week Study to Evaluate the Safety and Efficacy of 320 mg Valsartan and 80 mg Simvastatin in Combination and as Monotherapies in Treating Hypertension and Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
This 10-12 week study will provide data on the safety and efficacy of using 320 valsartan and 80 mg simvastatin together compared to using either one alone in lowering blood pressure and LDL cholesterol. After discontinuing current drug therapies for hypertension and hypercholesterolemia, patients will be given 320mg valsartan+80mg simvastatin, 320mg valsartan+placebo, or 80mg simvastatin+placebo..

Official Title
-----------------
A 10-12 Week Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of the Combination of Valsartan (320 mg) and Simvastatin (80 mg) Compared to Valsartan (320 mg) and Simvastatin (80 mg) Monotherapies in Essential Hypertension and Hypercholesterolemia

Conditions
-----------------
HYPERTENSION, HYPERCHOLESTEROLEMIA

Intervention / Treatment
-----------------
* Drug: valsartan + simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ESSENTIAL HYPERTENSION ELEVATED LDL-C CHOLESTEROL USING STABLE DOSE OF HMG CoA REDUCTASE INHIBITOR (STATIN) FOR 3+ MONTHS Exclusion Criteria: SEVERE HYPERTENSION EVIDENCE OF HISTORY OR CURRENT HEART DISEASE HISTORY OF STROKE OR MYOCARDIAL INFARCTION DISLIPIDEMIA OR HYPERTENSION DUE TO SECONDARY CAUSES UNCONTROLLED DIABETES OR INSULIN Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: valsartan + simvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average ambulatory systolic blood pressure over 24 hours |  |  | 
| Change in serum low density lipoprotein cholesterol (LDL-C ) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and serious adverse events at each study visit for 42 days |  |  | 
| Change in average ambulatory systolic blood pressure over 24 hours between two different treatment therapies |  |  | 
| Change in 24 hour ambulatory blood pressure in the daytime compared to nighttime |  |  | 
| Change in 24 hour ambulatory blood pressure 21-24 hours after last dose of study medication |  |  | 
| Change in total cholesterol, triglycerides, and high densitiy lipoprotein cholesterol (HDL-C) from baseline after 42 days |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HYPERTENSION, HYPERCHOLESTEROLEMIA, BLOOD PRESSURE, CHOLESTEROL, VALSARTAN, SIMVASTATIN
The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.

Study Overview
=================
Brief Summary
-----------------
Study to provide initial data to assess the safety and efficacy of tegaserod use in patients with dyspepsia that are being treated with proton pump inhibitors (PPI's) for heartburn.

Official Title
-----------------
The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.

Conditions
-----------------
Dyspepsia

Intervention / Treatment
-----------------
* Drug: Tegaserod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients 18 years or older. Self-reported presence of symptoms consistent with dyspepsia (including mid-upper abdominal discomfort characterized by post prandial fullness, early satiety and bloating) Stable dose PPI therapy of at least 4 weeks Exclusion Criteria: History of intestinal obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or of abdominal adhesions. Evidence that the dyspeptic symptoms are relieved by defecation and/or associated with a change in frequency or stool form. With a current most bothersome symptom of heartburn. Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tegaserod|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether tegaserod administered over 6 weeks results in improved dyspeptic symptoms characterized by epigastric discomfort vs placebo on patients taking PPIs for the treatment of heartburn (weekly global assessment) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of tegaserod vs. placebo for individual symptoms severity scores of postmeal fullness, early fullness while eating, bloating, abdominal pain, nausea, vomiting, heartburn, regurgitation and constipation (daily assessment) |  |  | 
| Quality of Life (weekly assessment) |  |  | 
| Safety and tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dyspepsia, hearburn, female, PPI
Epidemiology and Outcome of Ventilator-associated Pneumonia Among Critically Ill COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the risk factors for development of ventilator-associated pneumonia (VAP) and to identify the prognostic factors of VAP among Coronavirus Disease 2019 (CoViD-19) patients. We hypothesized that CoViD-19 serves as a high risk factor for the development of VAP and it affects clinical outcome measures negatively.

Detailed Description
-----------------
Coronavirus Disease 2019 (CoViD-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) became a pandemic affecting thousands of individuals worldwide. A considerable proportion of CoViD-19 patients require admission to the intensive care unit (ICU), although limited data are available on their clinical characteristics and course. The results of retrospective studies indicate older age, presence of comorbidies and secondary infections as predictors of mortality among this population. Further evaluation regarding ICU clinical course and predictors of mortality is needed. The aim of this study is to determine the risk factors for development of VAP and to identify the prognostic factors of VAP among CoViD-19 patients.

Official Title
-----------------
Epidemiology and Outcome of Ventilator-associated Pneumonia Among Critically Ill COVID-19 Patients

Conditions
-----------------
Ventilator Associated Pneumonia, Corona Virus Infection

Intervention / Treatment
-----------------
* Diagnostic Test: Assessment of ventilator-associated pneumonia criteria


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critically ill individuals diagnosed with PCR confirmed CoViD-19 disease Started mechanical ventilation for > 48 hours Informed consent signed by the patient or authorised representative Exclusion Criteria: Participation in an interventional trial aiming nosocomial infections refused informed consent

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Assessment of ventilator-associated pneumonia criteria|Diagnosis of ventilator-associated pneumonia is based upon the routine daily clinical and laboratory parameters.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day all-cause mortality |  | at study completion, anticipated 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of mechanical ventilation |  | average time frame expected 2-3 weeks | 
| ICU length-of-stay |  | average time frame expected 3-4 weeks | 
| Antibiotic utilization |  | average time frame expected 3-4 weeks (at discharge from ICU) | 
| Ventilator-associated pneumonia rate |  | at study completion, anticipated 5 months |
Validity and Reliability of the Turkish Version of the Pectus Carinatum Body Image Quality of Life Questionnaire for Patients With Pectus Carinatum

Study Overview
=================
Brief Summary
-----------------
In children with severe pectus carinatum, a significant loss of self-esteem, impairment in social behavior due to a decrease in quality of life associated with physical appearance and mental health has been reported. However, a questionnaire measuring these problems specific to this disease is not available in Turkish. Therefore, in our study, we aimed to investigate the validity and reliability of the Pectus Carinatum Body Image Quality of Life Questionnaire (PeCBI-QOL) in patients with Pectus Carinatum.

Official Title
-----------------
Validity and Reliability of the Turkish Version of the Pectus Carinatum Body Image Quality of Life Questionnaire for Patients With Pectus Carinatum

Conditions
-----------------
Pectus Carinatum, Quality of Life, Body Image, Brace

Intervention / Treatment
-----------------
* Other: Brace Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been diagnosed with Pectus Carinatum by a doctor (2 cm above the protrusion level) Between the ages of 10-18, Having dissatisfaction with this defect Exclusion Criteria: Having severe scoliosis (Cobb angle over 20 degrees) Having chronic systemic disease Having a serious psychiatric illness Having complex mixed type pectus deformity

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Brace Treatment|Body image and quality of life of individuals who have used brace will be evaluated|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pectus Carinatum Body Image Quality of Life Questionnaire | A questionnaire (Pectus Carinatum Body Image Quality of Life Questionnaire, PeCBI-QOL) was developed by Paulson et al. to be applied in the follow-up of Pectus Carinatum patients. The questionnaire includes 18 items for patients and 15 items for their families. The questionnaire has no validity and reliability in Turkish. | 15-21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Pectus Excavatum Evaluation Questionnaire | The Pectus Excavatum Evaluation Questionnaire (PEEQ) was developed and validated by Lawson et al to measure the physical and psychosocial quality-of-life changes after surgical repair of pectus excavatum. Each of the 17 items in the PEEQ is in a Likert scale format, where low scores indicate better outcome. | 15-21 days |
Pharmacokinetics and Metabolism Study in Healthy Male Participants

Study Overview
=================
Brief Summary
-----------------
Phase 1 Phamacokinetic and metabolism study of BMS-986205 in healthy males

Official Title
-----------------
Pharmacokinetics and Metabolism of [14C] BMS-986205 in Healthy Male Participants

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: BMS-986205


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight 75-95kg, BMI 18.0-32.0 kg/m^2 Refrain from sperm donation 110 days after dosing Exclusion Criteria: Current or recent gastrointestinal disease Any GI surgery that could impact drug absorption Active, known, or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria could apply

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Oral Dose of BMS-986205<br> | Drug: BMS-986205<br>* Carbon 14 tagged BMS-986205<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]) | Measured by plasma concentrations | up to 28 days | 
| Percent of Total Radioactivity Recovered in All Excreta (% total) | Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts | up to 28 days | 
| Half-Life (T-HALF) | Measured by plasma concentrations | up to 28 days | 
| Total Body Clearance (CLT) | Measured by plasma concentrations | up to 28 days | 
| Volume of Distribution during Terminal Elimination Phase (Vz/F) | Measured by plasma concentrations | up to 28 days | 
| Time to Maximum Observed Concentration (Tmax) | Measured by plasma concentrations | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) | Measured by investigator assessment | up to 28 days | 
| Results of electrocardiogram tests (ECGs) | Measured by investigator assessment | up to 28 days | 
| Results of vital sign measurements | Measured by investigator assessment | up to 28 days | 
| Results of clinical laboratory tests | Measured by investigator assessment | up to 28 days |