linjc16/ctgov huggingface dataset:
Azilect® In Wearing-Off (AIWO)

Study Overview
=================
Brief Summary
-----------------
End-of-dose fluctuations e. g. wearing-off are defined as a recurrence of motor and non-motor Parkinson's Disease (PD) symptoms that precedes a scheduled dose and improves with the next dose of anti-parkinsonian medication. Azilect® is approved and recommended for therapy of wearing-off-/End-of-dose fluctuations and improves motor fluctuations significantly in combination therapy with L-dopa and other parkinsonian medication.

Detailed Description
-----------------
The aim of the non-interventional study is to document efficacy and tolerability of rasagiline as a combination therapy in patients with wearing-off-/End-of-dose fluctuations and the effect of rasagiline on individual wearing-off symptoms, recognized by wearing-off questionnaire 32 (WOQ-32).

Official Title
-----------------
Azilect® In Wearing-Off (AIWO) Non-interventional Study on Efficacy and Tolerability of Rasagiline (1mg/d) add-on in Ambulatory Parkinson's Disease Patients With Wearing-off Symptoms Diagnosed by Wearing-off Questionnaire (WOQ-32)

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Azilect®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: idiopathic Parkinson's disease based on the UK Brain Bank criteria, Wearing-off / end-of-dose akinesia at least 18 years old, written consent to participate in the study. Exclusion: contraindications according to the SmPC of Azilect®, treatment with Azilect® in the past 3 months and / or suffering from a relevant cognitive impairment and therefore neither understand the patient information, nor can give their consent to participate.

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 |
| --- |
|Drug: Azilect®|AZILECT® 1mg Tablets|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wearing-off Questionnaire-32 (WOQ-32) | Alterations of 32 different wearing-off symptoms (Patient questionnaire) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO-5 | Alterations of patient's Quality of life (patient questionnaire) | 12 weeks | 
| GI-I | Self-Assessment of global improvement (patient questionnaire) | 12 weeks | 
| Columbia University Rating Scale (CURS) | Alteration of PD symptoms (physician rated questionnaires) | 12 weeks | 
| Clinical global impression improvement (CGI-I) | (physician rated questionnaires) | 12 weeks | 
| Percentage of participants with adverse events |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, akinesia, Azilect®, Rasagiline, Combination therapy with L-dopa, Wearing-off Questionnaire-32, Quality of life, Daily practice
Prevention of Falls in the Elderly Population

Study Overview
=================
Brief Summary
-----------------
An educational intervention will be utilized to improve care following guidelines for treating individuals at risk of falling. A survey will be administered to providers pre and post education.

Official Title
-----------------
Prevention of Falls in the Elderly Population

Conditions
-----------------
Accidental Falls

Intervention / Treatment
-----------------
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary care providers in Family Medicine and Internal Medicine Exclusion Criteria: Providers in outlying clinics

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education<br>Providers participating in education related to guidelines for treating patients at risk of falling | Behavioral: Education<br>* Education on guidelines for care of individuals at risk of falling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported adherence to guidelines for managing patients at risk of falls | A Fall Survey consisting of 11 questions will assess how providers self-report their assessment of patients at risk of falling. Scales will range from binary (yes/no) to up to 6 responses (very frequently, frequently, sometimes, infrequently or very infrequently). The survey will measure percent change in responses pre and post education. | 1year |
Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography

Study Overview
=================
Brief Summary
-----------------
This randomized study investigates the benefits of an additional Bispectral Index monitoring of depth of sedation during endoscopic retrograde cholangiopancreaticography. A bispectral index (BIS) monitor is a neurophysiological monitoring device which continually analyses a patient's electroencephalograms during general anaesthesia to assess the level of consciousness during anaesthesia.

Official Title
-----------------
Bispectral Index Monitoring as an Adjunct to Standard Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography

Conditions
-----------------
Gastrointestinal Endoscopy, Sedation

Intervention / Treatment
-----------------
* Device: BIS monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for ERCP (Endoscopic Retrograde Cholangiopancreatography) with midazolam and propofol sedation Exclusion Criteria: Missing informed consent ASA V Preexisting neurological deficit Known pregnancy Hypotension (RRsys<90mmHg), bradycardia (HR<50/min), hypoxia (SaO2<90%)

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIS monitoring<br>Dosing of sedatives with BIS monitoring | Device: BIS monitoring<br>* Neuromonitoring of depth of sedation with Bispectral Index<br>|
| No Intervention: Standard monitoring<br>Dosing of sedatives without BIS monitoring | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary complications of sedation |  | 1-4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of sedation |  | 1-4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Midazolam and propofol sedation, ERCP, Bispectral Index monitoring
Effect of Protein Concentration on Human Embryo Development

Study Overview
=================
Brief Summary
-----------------
Protein Concentration in Human Embryo Culture Media remains assigned to the manufacturers with no clear evidence on which concentration is ideal.

Official Title
-----------------
Protein Concentration and Human Embryo Development

Conditions
-----------------
Human Embryo Culture

Intervention / Treatment
-----------------
* Other: Effect of Protein on Blastocyst Development


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intracytoplasmic sperm injection cycles Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 mg/ml protein concentration in Embryo Culture Media<br> | Other: Effect of Protein on Blastocyst Development<br>* Embryo Development Related to The Protein Concentration<br>|
| No Intervention: 5 mg/ml protein concentration in Embryo Culture Media<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| embryo development |  | two months | 
| Blastocyst Formation | number of formed blastocyst per fertilized oocyte | two months | 
| Clinical pregnancy rate |  | 7 weeks | 
| Implantation rate |  | 7 weeks | 
| Miscarriage rate |  | 12 weeks |
Second Molecular Event Identification by Exome Sequencing for Intellectually Disabled Patients Carrying 16p13.11 CNVs

Study Overview
=================
Brief Summary
-----------------
16p13.11 copy number variations are considered as predisposition factors for neurodevelopmental disorders but can be inherited from normal parents. SEESIC aims at identifying seond molecular events by exome sequencing that could modulate the phenotype and explain familial discrepancies.

Official Title
-----------------
Second Molecular Event Identification by Exome Sequencing for Intellectually Disabled Patients Carrying 16p13.11 CNVs

Conditions
-----------------
Intellectual Disability

Intervention / Treatment
-----------------
* Genetic: Exome sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting intellectual disability Patients carrying a 16p13.11 copy number variant Blood DNA available without re sampling for the patient and his parents. Consent for genetics analysis already for the patient and his parents. Exclusion Criteria: - Other diagnosis for intellectual disability (apart 16p13.11 copy number variant) already posed
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients presenting intellectual disability and previously diagnosed as carriers of a 16p13.11 copy number variant using Cytogenetic Micro Array. | Genetic: Exome sequencing<br>* Detection of a second (likely) pathogenic molecular event on exome data for intellectual disability beyond the 16p13.11 Copy Number Variant.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Second pathogenic molecular event on exome data | Number of participants diagnosed as carrier of a (likely) pathogenic variation beyond 16p13.11 CNV through exome sequencing according to ACMG 2015 guidelines | 4 months |
Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism

Study Overview
=================
Brief Summary
-----------------
Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism.

Detailed Description
-----------------
The effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism in patient with obesity and acanthuses nigrican.

Official Title
-----------------
Effect of Melatonin on Body Composition, Glucose Metabolism and Lipid Metabolism

Conditions
-----------------
Acanthosis Nigricans, Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: melatonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age:18-60 years old; BMI ≥ 28 kg/m2； With acanthosis nigricans。 Exclusion Criteria: With liver, kidney, gastrointestinal or other major organic serious diseases, cancer, lactating women, pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br>Take one table at bedtime. | Dietary Supplement: melatonin<br>* Take one tablet (containing melatonin 3mg, calcium 52mg, vitamin B6 5mg) at bedtime everyday for 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance index | HOMA-IR:serum fasting insulin(mmol/L) × serum fasting glucose(mmol/L)/22.5 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) | 12 weeks | 
| Body weight | Body weight (kg) | 12 weeks | 
| Body fat | Body fat (%) | 12 weeks | 
| Neck circumference | Neck circumference (cm) | 12 weeks | 
| Waist circumference | Waist circumference (cm) | 12 weeks | 
| Total Cholesterol | Total Cholesterol (mmol/L) | 12 weeks | 
| Triglyceride | Triglyceride (mmol/L) | 12 weeks | 
| Low Density Lipoprotein | Low Density Lipoprotein (mmol/L) | 12 weeks | 
| High Density Lipoprotein | High Density Lipoprotein (mmol/L) | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acanthosis nigricans, Obesity
Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

Study Overview
=================
Brief Summary
-----------------
This study is an open-label, active-controlled,non-inferiority trial comparing efficacy and safety of levetiracetam versus valproate in idiopathic generalized tonic-clonic epilepsy.

Official Title
-----------------
Comparison Study of Efficacy and Safety of Levetiracetam Versus Valproate in Treatment of Idiopathic Generalized Tonic-clonic Seizures

Conditions
-----------------
Epilepsy, Idiopathic Generalized

Intervention / Treatment
-----------------
* Drug: Levetiracetam
* Drug: Valproate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≥16 At least 2 unprovoked generalized tonic-clonic seizures in last 2 years with at least one in last 6 months Normal brain MRI or MRI without epileptogenic lesion Normal electroencephalography(EEG) or existence of generalized epileptiform discharges without any focal epileptiform discharges. Signing consent form Exclusion Criteria: History of treatment by sodium valproate or levetiracetam History of treatment by any anti-epileptic drug in last 6 months Plan for pregnancy Using no certain contraceptive method History of past or current hepatic disease History of past or current renal disease History of past or current hematologic disease History of known psychiatric disease History of status epilepticus

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levetiracetam<br> | Drug: Levetiracetam<br>* Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred<br>* Other names: Levebel;|
| Active Comparator: Valproate<br> | Drug: Valproate<br>* Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Seizure | The time interval from the beginning of the study to occurrence of the first seizure | 6 months | 
| Seizure Freedom Rate |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Withdrawal Rate |  | 6 months | 
| Time to Withdrawal |  | 9 months |
Application of an Electronic Nose in the Early Detection of ASpergillosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the accuracy with which the eNose can discriminate patients with invasive pulmonary aspergillosis from controls.

Official Title
-----------------
The Application of an Electronic Nose in the Early Detection of ASpergillosis

Conditions
-----------------
Pulmonary Invasive Aspergillosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that are 18 years of age or older will undergo treatment for a hematological malignancy expected to result in grade 4 neutropenia (according to CTCAE 3.0, i.e. <0.5 x 109 neutrophils/L) of prolonged duration (i.e., more than 7 days), e.g. hematopoietic stem cell transplantation or induction/consolidation treatment for acute myeloid leukaemia have given written informed consent Exclusion Criteria: a previously diagnosed invasive mycosis the inability to perform the breathing manoeuvre needed for eNose-analysis of exhaled air

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| prolonged neutropenic patients<br>patients that will undergo treatment for a hematological malignancy expected to result in grade 4 neutropenia of prolonged duration | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy with which the Cyranose can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls with fever | The cross-validated accuracy with which the Cyranose can discriminate between patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls with fever, defined as the percentage of correctly classified patients using the leave-one out method | 4 days |
Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a relationship exists between the level of antituberculosis drugs (isoniazid, rifampin, ethambutol, and pyrazinamide) in the blood and the outcome of HIV-positive patients with tuberculosis. This study also evaluates how these drugs are absorbed and metabolized in the body.

Detailed Description
-----------------
Patients receive up to 8 weeks of two or more anti-tuberculosis drugs, of which at least two are isoniazid, rifampin, pyrazinamide, or ethambutol. Blood specimens are collected at 2, 6, and 10 hours after administration of study medication, once between Days 10 and 14 of a phase of daily treatment and once while on an intermittent dose regimen (twice weekly or three times weekly).

Official Title
-----------------
Pharmacokinetics of Antituberculosis Agents in HIV-Infected Persons With Tuberculosis

Conditions
-----------------
HIV Infections, Tuberculosis

Intervention / Treatment
-----------------
* Drug: Ethambutol hydrochloride
* Drug: Isoniazid
* Drug: Pyrazinamide
* Drug: Pyridoxine hydrochloride
* Drug: Rifampin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria You may be eligible for this study if you: Are HIV-positive and have tuberculosis. Are 13 years of age or older. Have written, informed consent of parent or guardian if you are under 18 years of age. Agree to practice abstinence or use barrier methods of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: Have any other disorder or condition which might cause study treatment to be undesirable. Are pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ethambutol hydrochloride|nan|
|Drug: Isoniazid|nan|
|Drug: Pyrazinamide|nan|
|Drug: Pyridoxine hydrochloride|nan|
|Drug: Rifampin|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
-----------------
Tuberculosis, Isoniazid, Pyrazinamide, Pyridoxine, Rifampin, AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome, Antitubercular Agents