linjc16/ctgov huggingface dataset:
Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Japan. The aim of this study is to collect information about the efficacy and safety of Norditropin® (somatropin) in the long-term treatment of short stature with GHD (Growth Hormone Deficiency) where epiphysial discs are not closed and short stature with Turner Syndrome where epiphysial discs are not closed.

Official Title
-----------------
A Multicentre, Open Label, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Child Patients With GHD or Turner Short Stature Without Closure of Epiphyseal Discs.

Conditions
-----------------
Growth Hormone Disorder, Growth Hormone Deficiency in Children, Genetic Disorder, Turner Syndrome

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Growth hormone deficiency or short stature due to Turner Syndrome where the epiphyseal discs are not closed Exclusion Criteria: Diabetic Patients with malignant tumors Women who are either pregnant or likely to be pregnant Known or suspected allergy to study product(s) or related products
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Somatropin<br> | Drug: somatropin<br>* Collection of safety and efficacy data in connection with use of somatropin (Norditropin®) in daily clinical practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in height |  | Week 0, Month 36, final height is reached | 
| Incidence of adverse reactions (ADRs) |  | 36 months, accumulation of study period |
Assessment of Sleep Disturbance in Alzheimer Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study circadian rhythms, or daily cycles of sleep, wake, and activity. The investigators hope to learn how disturbed sleep in Alzheimer's Disease relates to changes in activity cycles, and how sleep disturbances may affect your daytime alertness. This project selects patients suffering from memory problems, or voluntary to be in our Control Group. There are three parts to this study: Sleep Diaries, Behavioral Questionnaire, and Activity Recordings

Official Title
-----------------
Assessment of Sleep Disturbance in Alzheimer Disease

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Other: Analysis of sleep disturbance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: alzheimer disease MMSE > 20 over 65 years old Exclusion Criteria: new psychotropic drug treatment patient unable to do neuropsychologic tests

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Behavioral Questionnaire Sleep Recordings Genetic analysis | Other: Analysis of sleep disturbance<br>* Behavioral Questionnaire Sleep Recordings Genetic analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of apathy |  | at day 0, just after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of sleep disturbance |  | during a week, between day 0 and day 7 | 
| determine a genetic relationship between sleep disturbance and alzheimer disease |  | after all genetic analyses of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alzheimer disease, sleep disturbance, apathy, memory loss
Prevalence of Atelectasis in Critical Trauma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the prevalence rate and risk factors for pulmonary complications in patients with critical trauma who intubated and mechanical ventilation.

Official Title
-----------------
The Prevalence and Risk Factors for Lung Atelectasis in Patients With Critical Trauma Who Are Intubated and Mechanically Ventilated

Conditions
-----------------
Pulmonary Atelectasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An inclusion criterion is the traumatic patients (e.g. head injury, blunt chest, blunt abdomen, and fracture of spine; with or without operative, pure or multitrauma) with intubation and mechanical ventilation who admit at this time period will recruit to the study. Exclusion Criteria: a patients who admit less than 1 day will be excluded such as sudden death or moving to other ward because of improving conditions, etc.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with pulmonary atelectasis |  | from the date of randomization until the date of first documented of atelectasis, assessed up to 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with pneumonia |  | from the date of randomization until the date of first documented of pneumonia, assessed up to 1 years | 
| number of participants with pleural effusion |  | from the date of randomization until the date of first documented of pleural effusion, assessed up to 1 years | 
| number of participants with abnormal laboratory values | the laboratory test include arterial blood gases (ABG), Clinical chemistry test (i.e. Blood urea nitrogen, Creatinine, Sodium, Potassium, Phosphorus, Chloride, Magnesium). | from the date of randomization until the date of first documented of pleural effusion, assessed up to 1 years | 
| number of participants with adverse events that are related to treatment | These data are collected from medical records (i.e. arrhythmia, hypoxia) | from the date of randomization until the date of first documented of pleural effusion, assessed up to 1 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trauma, atelectasis
Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly effective drug. Quinine was suggested for treatment of patients with muscle cramps in patients with liver cirrhosis. However, thrombocytopenia, cardiac arrhythmias and cinchonism are serious side effects.

Detailed Description
-----------------
• The aim of the study was to assess the efficacy and safety of Gabapentin in the treatment of muscle cramps in patients with liver cirrhosis.

Official Title
-----------------
Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis

Conditions
-----------------
Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: Gabapentin
* Drug: Calcium Carbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver cirrhosis patients Exclusion Criteria: allergy to gapabentin. pregnancy and lactation. Renal failure.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gabapentin<br>Gabapentin twice daily | Drug: Gabapentin<br>* Gapapentin twice daily<br>* Other names: Gaptin;|
| Placebo Comparator: PLacebo<br>Calcium carbonate twice daily | Drug: Calcium Carbonate<br>* calcium carbonate twice daily<br>* Other names: Calcitron;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of muscle cramps |  | 3 months |
A Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in children with ADHD.

Official Title
-----------------
The Long-term Safety and Tolerability of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD): An Open-Label Extension Study

Conditions
-----------------
Attention-Deficit/Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: ABT-089


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject was randomized into Base Study (M06-888 or M10-345) and completed the Treatment Period. If female, subject must be practicing at least one method of birth control throughout the study. If female, the result of a pregnancy test is negative. The subject is judged to be in generally good health. Exclusion Criteria: The subject experienced a serious adverse event in Base Study (M06-888 or M10-345) that the investigator considered possibly or probably related to study drug. The subject has taken any ADHD medication between the last dose of study drug in Study M06-888 or M10-345 and the first dose of study drug in the current study. The subject has a positive urine drug screen for alcohol or drugs of abuse. The subject anticipates a move outside the geographic area.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ABT-089<br>* Up to 4 capsules will be taken once daily for 12 months. Dosage forms include 1 mg, 5 mg, 10 mg capsules and 40 mg tablets. Highest dose allowed is 80 mg per day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD-RS-IV (HV) |  | Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 | 
| CGI-ADHD-S |  | Day -1, Day 14, Months 1, 2, 3, 6, 9 & 12 |
Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting the central and peripheral motor neurons, characterized by the rapidity of its evolution (median survival of 3 years). The pathophysiology of the disease is still poorly understood. Neuronal death results from several cellular mechanisms entangled, including mitochondrial dysfunction. The absence of diagnostic marker causes a significant delay in diagnosis, on average a year. On the other hand, the wish biomarker is important for therapeutic trials. Recently, MRI sodium (23Na) demonstrated its importance to detect noninvasively sodium accumulations associated with neuronal suffering. This neuronal pain can be caused by mitochondrial dysfunction causing the accumulation in the sodium and calcium cell causing neuronal death. These studies were conducted in multiple sclerosis, Alzheimer's disease, Huntington's disease, stroke and brain tumors. They demonstrated that sodium MRI could be an effective and sensitive biomarker for detecting and quantifying neuronal degeneration. The goal of this study is to assess neuronal damage noninvasively by MRI sodium in amyotrophic lateral sclerosis.

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Other: sodium MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Amyotrophic lateral sclerosis patient according to the El Escorial criteria revised Brooks et al. 2000 bulbar or spinal beginning Exclusion Criteria: patient or healthy volonteer presenting MRI contre indications to this exam. patient or healthy volonteer presenting severe high blood pressure undergoing medication to treat it or not. patient or healthy volonteer having chronic psychiatric illness, dementia

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with amyotrophic lateral sclerosis<br>ALS patients with, spinal and bulbar form, certain or probable diagnosis according to the revised El Escorial criteria will go through the MRI sodium | Other: sodium MRI<br> <br> |
| Placebo Comparator: Healthy volunteer<br>Healthy Volonteer apparied for sexe and age with selected ALS patients will go through the MRI sodium | Other: sodium MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central conduction time of the potential muscle through transcranial magnetic stimulation |  | 4 hours |
ET-blockade and Exercise Induced Blood Flow in T2DM

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the effect of ET blockade on the acute exercise induced blood flow and endothelial function in subjects with T2DM. We hypothesize that combining ET - blockade with exercise training leads to an acute increase of exercise induced blood flow when compared with exercise alone. We expect that this will lead to an optimization of vascular training effect in T2DM.

Official Title
-----------------
Effect of a Dual ET-blocker on Exercise Induced Blood Flow and Endothelial Function in T2DM

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Mellitus (>2 years since diagnosis) OR controls Exclusion Criteria: <40 years of age >65 years of age smoking cardiovascular disease diabetes related manifest vascular complications Type 1 Diabetes Mellitus use of Glibenclamide use of HIV drugs use of calcineurin inhibitors use of drugs that interfere with CYP3A4 and CYP2C19

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bosentan<br>Single dose of Bosentan (125 mg) | Drug: Bosentan<br> <br> * Other names: 125 mg oral dose;|
| Placebo Comparator: Placebo<br>Single dose of placebo (125 mg) | Drug: Placebo<br> <br> * Other names: 125 mg oral dose;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise induced blood flow |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise induced Flow Mediated Dilation |  | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, endothelial function, exercise, blood flow, bosentan
Genetic Polymorphysm of Cholesterol 24 S Hydroxylase in Patients With Glaucoma and AMD

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the implicitement of the cholesterol 24 S hydroxylase gene and the 24 S hydroxycholesterol in glaucoma and in age related macular degeneration.

Official Title
-----------------
Etude du Polymorphysme génétique de la cholestérol 24S Hydroxylase et Des Teneurs en 24S hydroxycholestérol Chez Des Patients Atteints de Glaucome ou de dégénérescence Maculaire liée à l'âge.

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Biological: Assessing the blood level of cholesterol 24 S Hydroxylase
* Biological: Assessing the blood level of cholesterol 24 S hydroxylase
* Biological: assessing the blood level of cholesterol 24 S hydroxylase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with Glaucoma Patient with AMD Healthy patient Exclusion Criteria: All patients who use any treatment in order to maintain in normal value their blood cholesterol

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

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: G<br> | Biological: Assessing the blood level of cholesterol 24 S Hydroxylase<br>* Comparison of venous blood level of Cholesterol 24 S hydroxylase and 24 hydroxycholesterol in patients with Glaucoma and AMD and in healthy subjects.<br>|
| Active Comparator: AMD<br> | Biological: Assessing the blood level of cholesterol 24 S hydroxylase<br>* Comparison of venous blood level of cholesterol 24 S hydroxylase and 24 hydroxycholesterol in patients with Glaucoma, AMD end in healthy subjects<br>|
| Active Comparator: Healthy subjects<br> | Biological: assessing the blood level of cholesterol 24 S hydroxylase<br>* Comparison of venous blood level of cholesterol 24 S hydroxylase and 24 hydroxycholesterol in patients with glaucoma, AMD and in healthy subjects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To know if cholesterol 24 S hydroxylase and 24 hydroxycholesterol are involve in Glaucoma and AMD |  | 2 years |
Clinical Applications of a Joystick in Femoral Shaft Fractures

Study Overview
=================
Brief Summary
-----------------
This study will use a new H joystick for reduction on patients with femur fractures to investigate the reduction time, operating time and bone healing status for the evaluation of the clinical application benefits of this joystick.

Detailed Description
-----------------
This study will design a new H joystick for reduction (which has received the national utility model patent) and will use this equipment on 80 patients (55 males, 25 females) with femur fractures to investigate the reduction time, operating time and bone healing status for the evaluation of the clinical application benefits of this joystick.

Official Title
-----------------
Studying the Clinical Applications of H Joystick for Reduction in Femoral Shaft Fractures

Conditions
-----------------
Femur Shaft Fracture

Intervention / Treatment
-----------------
* Device: H joystick
* Procedure: Common reduction methods


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Femur shaft fractures Exclusion Criteria: Not suitable to receive intramedullary nail treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: H joystick<br>Patients are treated with the H joystick on a traction table | Device: H joystick<br>* A joystick that corrects lateral displacement and angulation for multi-direction reduction<br>|
| Active Comparator: Common reduction methods<br>Patients are treated with common reduction methods on a traction table | Procedure: Common reduction methods<br>* Manual reduction methods without the assistance of any devices<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time | Duration of operation | One day | 
| Fluoroscopy times | The number of times for fluoroscopy | One day | 
| Blood loss | The amount of blood loss | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
closed reduction, locked intramedullary nailing