linjc16/ctgov huggingface dataset:
Beta Glucosylceramide for Treatment of NASH

Study Overview
=================
Brief Summary
-----------------
Oral administration of betaglucosylceramide was shown effective in reducing inflammation in animal models and was found safe in humans.

Detailed Description
-----------------
Patients with NASH to receive the treatment versus placebo for 40 weeks followed by a liver biopsy.

Official Title
-----------------
Beta Glucosylceramide for Treatment of Non Alcoholic Steatohepatitis

Conditions
-----------------
Compliance Behavior

Intervention / Treatment
-----------------
* Drug: Beta Glucosylceramide
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven NASH Exclusion Criteria: Other therapies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Normal saline administered orally daily as a placebo | Drug: Placebo<br>* normal saline<br>* Other names: normal saline;|
| Active Comparator: Beta Glucosylceramide<br>Beta glucosylceramide administered orally daily | Drug: Beta Glucosylceramide<br>* Beta Glucosylceramide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Decrease of 2 Points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) Analysis is Per Protocol | Number of Participants who had a decrease of 2 points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) from baseline at 40 weeks per protocol analysis. The score is performed on the liver biopsy before and after treatment. The total score is used with a range from 4-16. A decrease in the total score by 2 points or more is considered an improvement, while an increase in the total score by 2 points or more is considered deterioration. No use of subscales for the data analysis was made. Allparticipants in both arms who showed a decrease of 2 points or more in the Non-Alcoholic Fatty Liver Disease Activity Score are conisdered as responders. Only values quantifying data that were actually measured and analyzed are included. | Total score from baseline compared with week 40. |
Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea (OSA) Patients

Study Overview
=================
Brief Summary
-----------------
Describe blood pressure changes on patients with OSA treated with lateral pharyngoplasty Compare the mean of systolic and diastolic blood pressure in 24 hours, average systolic and diastolic pressure during daytime and night and changes in the nocturnal decrease.

Detailed Description
-----------------
The variables are: Ambulatory blood pressure data Snoring scale BMI neck circumference abdominal circumference medications and life style changes

Official Title
-----------------
Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea Patients

Conditions
-----------------
Obstructive Sleep Apnea, High Blood Pressure

Intervention / Treatment
-----------------
* Procedure: Lateral Pharyngoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Patient BMI < 35 no Benzodiazepinec User Exclusion Criteria: BMI > 35 Use of benzodiazepinecs Clinical contra-indications to surgery (ASA III or ASA IV)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: Surgical outcome<br>20 consecutive cases of patients who underwent the lateral pharyngoplasty | Procedure: Lateral Pharyngoplasty<br>* surgery lateral pharyngoplasty: consists on the section and rotation of the superior constrictor pharyngeal muscle associated with the ressection of the palatopharyngeus preserving the palatoglossus and mucosa of posterior and anterior tonsilar pillar , bilaterally.<br>|

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
-----------------
OSA, Blood pressure, Lateral Pharyngoplasty
Video-supported Group-based Otago Exercise Programme on Physical Performance in Older Adults.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the effects of a video-supported group-based Otago exercise programme intervention on balance, mobility, physical performance and aerobic endurance in community-dwelling older adults 65+ years old.

Official Title
-----------------
Effectiveness of a Video-supported Group-based Otago Exercise Programme on Physical Performance in Community-dwelling Older Adults: a Pilot Randomized Controlled Trial

Conditions
-----------------
Healthy Aging

Intervention / Treatment
-----------------
* Other: Exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 65 years and older. Living in the community (Valencia, Spain). Able to ambulate independently without a walking aid. Have no severe medical contraindication for physical activity. Able to communicate. Have self-reported visual and auditory capacities to follow commands. Provide signed informed consent. Exclusion Criteria: Unable to ambulate independently. Mini-mental state examination score of <24. Barthel Index score of <80. Severe visual and auditory disabilities. Unstable cardiovascular disease. Neurological disorder that could compromise them from exercising. Upper or lower extremity fracture in the past year.

Ages Eligible for Study
-----------------
Minimum 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: Treatment
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Exercises routine based on the Otago exercise programme | Other: Exercise training<br>* Exercises routine based on the Otago exercise programme<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Timed Up and Go test | General mobility measurement | Pre intervention and after 4-month intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Berg Balance Scale | Functional Balance measurement | Pre intervention and after 4-month intervention | 
| Change in the 6.min Walk Test | Aerobic Endurance Measurement | Pre intervention and after 4-month intervention | 
| Change in the One-Leg Stand | One-leg Balance Measurement | Pre intervention and after 4-month intervention | 
| Change in the Short Physical Performance Battery | Lower Limb Functional Measurement | Pre intervention and after 4-month intervention |
Drug-drug Interaction Study of Aripiprazole and Lamotrigine in Patients With Bipolar Type I Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to learn if aripiprazole has a drug-drug interaction with lamotrigine.

Official Title
-----------------
Effects of Aripiprazole on the Steady-State Pharmacokinetics of Lamotrigine in Subjects With Bipolar I Disorder

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) of 18 to 40 kg/m2 Subjects with bipolar I disorder who are clinically stable on a stable dose of at least 100 mg lamotrigine for at least 4 weeks prior to study entry Men and women, ages 18 to 65 Exclusion Criteria: Women who are pregnant or breastfeeding Patients with any significant acute or chronic medical illness, other than bipolar I disorder Subjects with active psychotic symptoms History of head trauma within the past 2 years History of akathisia requiring treatment History of tardive dyskinesia or abnormal involuntary movements Subjects with a predisposition to orthostatic hypotension Positive urine screen for drugs of abuse Use of narcotic-containing agents, amphetamines, or hormonal contraceptives within 4 weeks of study start

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: aripiprazole<br>* Tablets, Oral, 10, 20, or 30 mg (titrated), once daily, 14 days.<br>* Other names: Abilify;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Cmax (maximum drug concentration) and AUC(Tau) (exposure) of lamotrigine at the beginning of the study (Day-1) and when the subject completes the study (Day 36) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety and tolerability of aripiprazole when co-administered with lamotrigine for up to 4 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar type I Disorder
Evaluation of Efficacy and Tolerability of Micardis® / MicardisPlus® Under Usual Daily-practice Prescribing in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
To evaluate efficacy and tolerability of Micardis® / MicardisPlus® under usual daily-practice prescribing conditions with a special emphasis on controlling morning blood pressure

Official Title
-----------------
Morning Hypertension and Monitoring of Metabolism (AWB Morgenhochdruck & Stoffwechselmonitoring)

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Telmisartan
* Drug: Telmisartan in combination with hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Age ≥ 18 years, insufficiently treated hypertension Exclusion Criteria: - Age < 18 years

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Essential hypertension<br> | Drug: Telmisartan<br> <br> Drug: Telmisartan in combination with hydrochlorothiazide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in morning blood pressure (BP) |  | Pre-dose, up to 6 months after start of treatment | 
| Changes in metabolic laboratory parameters |  | Pre-dose, up to 6 months after start of treatment | 
| Changes in morning blood pressure in patients with or without telemonitoring (TM) of BP |  | Pre-dose, up to 6 months after start of treatment | 
| Investigator assessment of efficacy in reducing morning hypertension on a 5-point rating scale |  | Up to 6 months after start of treatment | 
| Investigator assessment of effects on metabolism on a 3-point rating scale |  | Up to 6 months after start of treatment | 
| Investigator assessment of tolerability on a 5-point rating scale |  | Up to 6 months after start of treatment | 
| Number of patients with adverse events |  | Up to 6 months | 
| Changes in morning heart rate |  | Pre-dose, up to 6 months after start of treatment |
Post-Covid Condition Cohort: Evolution of Symptomatology, Patient Profile and Associated Prognostic Factors

Study Overview
=================
Brief Summary
-----------------
The aim of our cohort is to collect prospectively, in a standardized and exhaustive manner, the health data of patients referred to the CAPCoV, our holistic referal post covid clinics for post-covid condition in order to be able to identify typical profiles of patients suffering from post covid syndrome and to follow the evolution of their disease over time.

Official Title
-----------------
Post-Covid Condition Monitoring Cohort: Evaluation of the Evolution of Symptomatology, Patient Profile and Associated Prognostic Factors

Conditions
-----------------
Long COVID, Post-Acute COVID-19, Post-Acute COVID19 Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: outpatients treated in the Nancy University Hospital Long Covid Support and Care Center for post-Covid condition according to WHO definition Exclusion Criteria: patient opposing the processing for research purposes of their data collected in routine care for their care

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 |
| --- | --- | --- |
| Symptoms | Symptoms collected in a standardized manner during consultations, their persistence over time, their evolution (improvement, stagnation, worsening) and their severity (mild, moderate, severe) | every 6 months up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical history |  | baseline | 
| fatigue | Chalder scale: range 0 to 33, >22/33 classified severe | every 6 months up to 3 years | 
| Dyspnea | mMRC | every 6 months up to 3 years | 
| Cognitive impairement | Montréal Cognitive Assessment : range 0 to 30, <26/30 classified pathologic | every 6 months up to 3 years | 
| inappropriate hyperventilation syndrome | Nijmegen score: range 0 to 64, >23/34 classified possible inapropriate hyperventilation syndrome | every 6 months up to 3 years | 
| additional examinations | Biology, imaging | every 6 months up to 3 years |
Sahlgrenska Cardiomyopathy Project

Study Overview
=================
Brief Summary
-----------------
This is a joint project by Sahlgrenska University Hospital: Sahlgrenska, Östra and Mölndal. Our objective is to diagnose and map patients with well phenotyped cardiomyopathies (CMP) including in depth clinical and molecular phenotyping to enable earlier and specific treatment. The project will serve as: resource for diagnostic and therapeutic trials common biomaterial bank resource for detailed molecular analyses on patients' biomaterials and patient specific symptoms and examination results

Official Title
-----------------
Sahlgrenska University Hospital Cardiomyopathy Project: Mapping and Diagnosis of Cardiomyopathies to Enable Early and Specific Treatment

Conditions
-----------------
Dilated Cardiomyopathies, Hypertrophic Cardiomyopathy, Restrictive Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy, Myocarditis, Sarcoidosis With Myocarditis, Giant Cell Myocarditis, Amyloidosis; Heart (Manifestation)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with primary cardiomyopathies including hereditary and inflammatory dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, left ventricular non-compaction cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, myocarditis, giant cell myocarditis, sarcoidosis and amyloidosis engaging the heart Exclusion Criteria: Patient with other preexisting cardiac diseases such as significant valvular, ischemic or pericardial disease before they receive a cardiomyopathy diagnose patients < 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Dilated Cardiomyopathy<br> | |
| Myocarditis<br> | |
| Sarcoidosis Heart<br> | |
| Giant Cell Myocarditis<br> | |
| Amyloidosis Heart<br> | |
| Hypertrophic Cardiomyopathies<br> | |
| Left Ventricular Myocardial Noncompaction Cardiomyopathy<br> | |
| Arrhythmogenic Right Ventricular Cardiomyopathies<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression |  | 2018-2028 |
Small Bowel Obstruction and Surgery

Study Overview
=================
Brief Summary
-----------------
Postoperative management after small bowel obstruction (SBO) surgery is not consensual and better knowledge of risk factors for postoperative morbidity could help to add evidence of the feasibility of enhanced recovery programs (ERPs). In elective surgery, ERPs have shown a significant benefit for the patient but this is not performed routinely in emergency surgery due to the difficulty to avoid postoperative nasogastric tube. The aim was to identify risk factors for postoperative morbidity and for nasogastric tube (NGT) replacement after SBO surgery.

Official Title
-----------------
Nasogastric Tube After Small Bowel Obstruction Surgery is Not Mandatory: a Retrospective Cohort Study

Conditions
-----------------
Acute Small Intestine Obstruction

Intervention / Treatment
-----------------
* Procedure: Nasogastric tube removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgical management of Small bowel obstruction due to adhesions Exclusion Criteria: obstruction not caused by single band adhesion matted adhesions, or if they were less than 18 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| systematic nasogastric tube<br>NGT was left systematically after surgery and removed after the first flattus | |
| Non systematic nasogastric tube<br>Nasogastric tube was removed immediately after surgery and was replaced in case of vomiting | Procedure: Nasogastric tube removal<br>* Nasogastric tube was removed immediately after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative morbidity | morbidity classified according to Dindo Clavien classification | within 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasogastric tube replacement | nasogastric tube replacement after removal | within 30 days |
Association of Multiple Genetic Polymorphisms With Clozapine-Associated Metabolic Change in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
We are going to investigate the association of multiple genetic polymorphisms with the metabolic side effects in patients with schizophrenia taking clozapine.

Detailed Description
-----------------
The use of antipsychotics, especially clozapine and olanzapine is associated with metabolic side effects, which put patients with schizophrenia at risk for cardiovascular morbidity or diabetes. The prevalence of the metabolic syndrome was 53.8% of patients who taking clozapine. The high interindividual variability in antipsychotic-induced metabolic abnormalities suggests that genetic makeup is a possible determinant. The genotypes of the multiple gene such as HTR2C, LEP, adrenergic receptor,PPAR,GNB3 are suggested to have associations with the metabolic side effects (weight,glucose,lipid,BP,metabolic syndrome) in patients using antipsychotics. We are going to investigate whether those multiple genetic polymorphisms are associated with the metabolic side effects in patients taking clozapine.

Official Title
-----------------
Cross-Sectional Study of the Association Between Multiple Genetic Polymorphisms and the Metabolic Side Effects in Patients With Schizophrenia Taking Clozapine More Than 1 Year

Conditions
-----------------
Schizophrenia, Metabolic Syndrome, Genetic Polymorphism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-65 who can understand and sign the informed consent Exclusion Criteria: who refuse to participate this study

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| clozapine group<br>chronic schizophrenia have been taking clozapine at leaset one year without diabetes, pulmonary tuberculosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The associations between multiplegenetic polymorphisms (HTR2C,leptin,adrenergic receptor,PPAR,GNB3) and the metabolic side effects (weight,glucose,lipid,BP,metabolic syndrome) |  | more than 1 year after starting clozapine | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, metabolic side effect, clozapine, genetic polymorphism