linjc16/ctgov huggingface dataset:
Bone Status and Insulin Resistance in Hirsutism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate how the bones of hirsute women are different from bones of healthy women. The change in hormone content in the blood will also be investigated. The study can be used to evaluate whether it will be relevant to bone scan all newly referred hirsute women. Hirsute women are often over-weight and often have an increased amount of the male sex hormone in their blood. Their blood tests often show changes reminding of the ones seen in diabetic patients. All hirsute women referred to the department will undergo an investigation revealing the reason for the increased hair growth. The investigation includes clinical investigation (height, weight and degree of hair growth), blood tests (for hormone status and bone status analysis) and bone scanning of the abdomen (body composition). The trial includes a group of 50 strongly hairy women and a control group of 50 healthy women with normal hair growth. They are matched by body weight, since weight has great importance for the bone mineral content and thereby for osteoporosis in the long run.

Official Title
-----------------
Body Composition, Insulin Concentration, Androgens and Bone Status in Women Referred With Hirsutism

Conditions
-----------------
Hirsutism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hirsute subjects: Belonging to group 1 or 2. Age: 20-46 Hirsute score: >7 Written informed consent Control group: Age: 20-46 Hirsute score: 0 (without razing) Regular menses Written informed consent Exclusion Criteria: Previous cosmetic treatment for hirsutism. Use of contraceptive pill (within the past 6 months) Systemic steroid treatment > 6 weeks (ever) Age above 46 years/post menopause (increased FSH) Recognized diabetes mellitus or other endocrine disease Eating disorder Serious, treatment demanding disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 46 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hirsutism, Bone status, Androgens, insulin
Mulligan Therapy Effects In Healthy Subjects With Induced Vertigo

Study Overview
=================
Brief Summary
-----------------
This analysis aims to evaluate the immediate effect that cervical sustained natural apophyseal glides (SNAGs) have on a group of individuals with induced vertigo by a caloric vestibular stimulation.

Official Title
-----------------
Mulligan Therapy Effects In Healthy Subjects With Induced Vertigo. A Randomized And Controlled Clinic Study

Conditions
-----------------
Vertigo

Intervention / Treatment
-----------------
* Procedure: sustained natural apophyseal glides
* Procedure: SHAM SNAG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects, Age 18-44 years. Exclusion Criteria: Consume of antipsychotics, antidepressants, antiarrythmics and/or anticonvulsivants Hippoacusia Auditory diseases Peripheral or central vestibulopathies Cerviogenic dizziness Balance disorders Nistagmus Oculomotor nerve dysfunctions Migraine Cervical osteoporosis, lashing or fracture Discal cervical hernia Cervical neuropathy Psychriatic disorders Epilepsy Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SNAG GROUP<br>The SNAG group received a treatment based on sustained apophyseal glides in a postero-anterior direction on C2 with a dose of three series of ten repetitions each, combined with active cervical extension. | Procedure: sustained natural apophyseal glides<br>* It consists on a sustained apophyseal glides in a postero-anterior direction on C2 with a dose of three series of ten repetitions each<br>* Other names: SNAG;|
| Sham Comparator: SHAM SNAG GROUP<br>The placebo SNAG group received a simulation of the contact used for the SNAGs, without any vertebral glide, and with an active cervical extension. | Procedure: SHAM SNAG<br>* Subjects on SNAG group received a simulation of the contact used for the SNAGs, without any vertebral glide, and with an active cervical extension<br>|
| No Intervention: CONTROL GROUP<br>The control group did not receive any type of intervention, they only waited for four minutes, sat down on a chair | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vHIT (Video Head Impulse Test) | Detection of peripheral vestibular deficits and their recovery | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | state-trait anxiety was measured at the beginning of the study using the Spanish version of the trait-state anxiety inventory (STAI) | 5 minutes |
Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage AD Having Coexisting svCVD

Study Overview
=================
Brief Summary
-----------------
Rivastigmine, an acetylcholinesterase inhibitor which has been approved by FDA & HSA, is authorized for use in the treatment of mild to moderate dementia of the Alzheimer's type. In this trial, the investigators will be studying the effectiveness of Rivastigmine in subjects with AD and cerebrovascular disease.

Official Title
-----------------
Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage Alzheimer's Disease Having Coexisting Small Vessel Cerebrovascular Disease

Conditions
-----------------
Alzheimer Disease, CVA (Cerebrovascular Accident)

Intervention / Treatment
-----------------
* Drug: Rivastigmine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 50-85 years Diagnosis of dementia of the Alzheimer's type according to the National Institute of Ageing-Alzheimer's Association Criteriah MRI brain (with T2 or FLAIR sequences) performed within a 12 month period from time of recruitment demonstrating the presence of WMH of ≥2 on the Fazekas scale (Score range of 0-3 wherein a score of 1 indicates mild WMH, 2 indicates moderate WMH and 3 indicates severe WMH).i Clinical Dementia Rating score of 1-2j Mini-Mental State Examination (MMSE) scores of 12-26 inclusivek English or Mandarin speaking, literate participants Exclusion Criteria: Severe neurological, psychiatric or systemic disease which in the opinion of the clinician could interfere with trial assessments The use of any investigational drugs, new psychotropic or dopaminergic agents, cholinesterase inhibitors or anti-cholinergic agents during the 4 weeks prior to recruitment Known skin allergy or previous allergic reaction to Rivastigmine patch

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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: Rivastigmine (Exelon) Patch<br>For the first 4 weeks of the study, subjects will receive Rivastigmine patch 4.6mg/24 hours. Thereafter, subjects will receive Rivastigmine patch 9.5mg/24 hours. | Drug: Rivastigmine<br> <br> * Other names: Exelon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Demonstrated Benefit in Global and Cognitive Measures |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 2 Years |
Changes in Myocardial Perfusion During Chronic Multi Site Biventricular Versus Right Ventricular Apex Pacing in Patients With Normal Left Ventricular Function Undergoing His Bundle Ablation for Drug-refractory Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
To determine whether Biventricular pacing in patients undergoing HIS bundle ablation for atrial fibrilation has beneficial effects on myocardial perfusion and left ventricularr ejection fraction.

Official Title
-----------------
Changes in Myocardial Perfusion During Chronic Multi Site Biventricular Versus Right Ventricular Apex Pacing in Patients With Normal Left Ventricular Function Undergoing His Bundle Ablation for Drug-refractory Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: HIS buldle ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal to nearly normal LVF (EF > 40%) Drug-refractory, persistent or permanent atrial fibrillation Referred for His ablation Exclusion Criteria: Unwilling or unable to sign the informed consent Life expectancy < 1year from non-cardiac causes Previous myocardial infarction Previous coronary bypass surgery Poor left ventricle function (EF< 40%) from any cause Symptomatic obstructive coronary artery disease Poor ultra sound imaging quality.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>First 3 months of biventricular pacing, second 3 months right ventricular apical pacing | Device: HIS buldle ablation<br>* HIS bundle ablation, followed by implant of a biventricular pacemaker<br>|
| Active Comparator: 2<br>First 3 months of right ventricular apical pacing, second 3 months biventricular pacing | Device: HIS buldle ablation<br>* HIS bundle ablation, followed by implant of a biventricular pacemaker<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in size of myocardial perfusion abnormalities in the two treatment groups as measured with MPS. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myocardial perfusion, His ablation, biventricular pacing, His bundle ablation for atrial fibrillation
AVODART® Alopecia Post-marketing Surveillance (PMS)

Study Overview
=================
Brief Summary
-----------------
Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in Korean androgenetic alopecia patients

Detailed Description
-----------------
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and effectiveness of dutasteride administered in Korean androgenetic alopecia patients according to the prescribing information

Official Title
-----------------
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and Effectiveness of AVODART® Administered in Korean Androgenetic Alopecia Patients According to the Prescribing Information

Conditions
-----------------
Alopecia

Intervention / Treatment
-----------------
* Drug: Dutasteride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men (18-41 years of age) with male pattern hair loss (androgenetic alopecia) Subjects with no experience of treatment using dutasteride Subjects who the investigator believes that they can and will comply with the requirements of the protocol Subjects who prescribed with dutasteride according to the Prescribing Information Exclusion Criteria: Considering the nature of observational study, GSK Korea encourages the doctors participating in this study to enrol the subjects prescribed with dutasteride following the locally approved Prescribing Information. Subject who give informed consent is enrolled. However, if institution waives the requirement for informed consent, informed consent is not required. In this case, monitoring does not proceed.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 41 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dutasteride<br>Patients administrated dutasteride with male hair loss | Drug: Dutasteride<br>* Basically there is no treatment allocation. Subjects who would be administered of dutasteride at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse event after dutasteride administration |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of unexpected adverse drug reaction after dutasteride administration |  | 2 years | 
| Occurrence of serious adverse events after dutasteride administration |  | 2 years | 
| Effectiveness of dutasteride judged by a physician |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dutasteride
Quality of Life Analysis of Treatment in Patients With Prostate Cancer on Adjuvant Zoladex Therapy

Study Overview
=================
Brief Summary
-----------------
This is an open label, non-interventional quality of life analysis for Zoladex treated prostate cancer patients by investigator's questionnaire

Official Title
-----------------
Quality of Life Analysis of Prostate Cancer Patient's Therapy

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent Early or locally-advanced prostate cancer patients on androgen deprivation therapy Investigators are requested to recruit patients only with at least 1 month prior Zoladex treatment. Exclusion Criteria: Allergy to substance of medication Prostate cancer patients with advanced disease
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Elements of a general and three disease-specific investigator questionnaire |  | Quarterly (plus or minus 3 days ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Assessment Report |  | Yearly (plus or minus 1 week ) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life
Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the following about donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease in clinical practice: cognitive function, Functional Assessment Staging (FAST) score, adverse events/adverse drug reactions, and patient background.

Official Title
-----------------
Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-

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

Intervention / Treatment
-----------------
* Drug: donepezil hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients diagnosed with Alzheimer's Disease by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Patients diagnosed with mild or moderate Alzheimer's Disease, applicable to FAST score 4 or 5. Exclusion criteria: Patients with history of hypersensitivity to component of Aricept or piperidine derivative. Patients registered for this survey before.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | Drug: donepezil hydrochloride<br>* This is a multicenter, open-labeled, practice-based, post-marketing surveillance study. Therefore, dosing is not specified.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The transition of clinical condition is evaluated comparing the result of HDS-R,MMSE with the time of study initiation |  | 48 months(12 weeks and every 6 months) |
Use of Microscopy, Cultures and Molecular Biological Methods for Diagnosing Nosocomial Pneumonia

Study Overview
=================
Brief Summary
-----------------
Nosocomial pneumonia in the Intensive Care Unit is often not properly diagnosed mainly due to ongoing antimicrobial therapy. The study investigates the feasibility of more advanced diagnostic technics.

Detailed Description
-----------------
ICU patients fulfilling the CDC criteria for nosocomial pneumonia and mechanically ventilated for no more than 24 hours are included in the study. The material for the diagnostic procedure is pulmonal secretion collected by 1. suctioning in the tracheal tube and 2. bronchioalveolar lavage. The diagnostic procedures are culturing, 16S and18S gene PCR and subsequent sequencing. The 3 diagnostic methods will be compared in order of proper diagnosis and the ability to determine a specific antimicrobial treatment.

Official Title
-----------------
Use of Microscopy, Cultures and Molecular Biological Methods for Diagnosing Nosocomial Pneumonia in Patients Admitted to the Intensive Care Unit - an Exploratory Study

Conditions
-----------------
Nosocomial Pneumonia

Intervention / Treatment
-----------------
* Diagnostic Test: Microbiological diagnostics on pulmonary secretion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients intubated because of respiratory failure following nosocomial pneumonia Exclusion Criteria: Terminal patients Patients with lung cancer Intubated for more than 24 hours at the sampling time Not fulfilling the CDC criteria for nosocomial pneumonia

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 |
| --- | --- |
| Adults with nosocomial pneumonia<br>Diagnostic procedures on pulmonary secretion collected by tracheal suctioning and bronchoalveolar lavage. | Diagnostic Test: Microbiological diagnostics on pulmonary secretion<br>* Culture, 16s, 18s, next generation sequencing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of patients where the advanced methods are superior to routine | Ratio of patients diagnosed by 16s, 18s or NGS to total number of patients compared to ratio of patients diagnosed by routine method (culture) | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nosocomial, Pneumonia, Diagnostics, 16s, 18s, PCR, Next Generation Sequencing
Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

Study Overview
=================
Brief Summary
-----------------
To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.

Official Title
-----------------
A 14 Day Randomized, Open-Label, Cross-Over, Single Center, Outpatient Study of Depakote Delayed-Release or Depakote Sprinkle vs. Divalproex Sodium Extended-Release in Child and Adolescent Patients With Epilepsy

Conditions
-----------------
Pediatric Epilepsy

Intervention / Treatment
-----------------
* Drug: Depakote Delayed-Release/Depakote Sprinkle
* Drug: Depakote ER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patient with a clinical diagnosis of epilepsy considered stable by the investigator. Must be in good physical health, on the same dose of all medications, including Depakote and other AEDs, for 2 week period prior to randomization. Minimum body weight of 37 lbs. Exclusion Criteria: Six-month history of drug or alcohol abuse. Status epilepticus within 6 months prior to screening. Abnormal platelet or ALT/AST levels.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence Group I<br>Depakote Delayed Release/Depakote Sprinkle | Drug: Depakote Delayed-Release/Depakote Sprinkle<br>* Administered according to the subject's usual regimen.<br>* Other names: divalproex sodium;|
| Experimental: Sequence Group II<br>Depakote ER | Drug: Depakote ER<br>* Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle.<br>* Other names: divalproex sodium;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of seizures |  | 2 weeks | 
| Number of Adverse Events |  | 2 weeks |