linjc16/ctgov huggingface dataset:
Study to Compare Two Formulations of Lamotrigine in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study intends to compare the pharmacokinetic characteristics, safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers

Official Title
-----------------
An Open-label, Randomised, Single-dose, Parallel-group Study to Evaluate the Pharmacokinetic Characteristics, Safety and Tolerability of up to Two Formulations (With Different Taste Masking Approaches) of an Orally Disintegrating Tablet (ODT) of Lamotrigine at 25mg and 200mg Versus the Immediate Release (IR) Lamotrigine in Healthy Subjects

Conditions
-----------------
Mental Disorders

Intervention / Treatment
-----------------
* Drug: Lamotrigine
* Drug: GI267119


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight >50 kg (males) or >45 kg (females) and BMI within the range 19 to 30 kg/m2 inclusive. Exclusion Criteria: Female subjects of childbearing potential will not be eligible to participate if they are unwilling or unable to use an appropriate method of contraception at least 30 days prior to the first study drug through 30 days. Female subject is pregnant (positive serum human chorionic gonadotrophin (hCG) test at Screening and pre-dose to the study) or lactating. Female subjects using hormonal contraceptive precautions including progesterone-coated intra-uterine device (IUD). Female subjects using hormonal replacement therapy. History of regular alcohol consumption Current smokers of 10 or more cigarettes per day

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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: GI267119<br>25 mg ODT tablet strength | Drug: Lamotrigine<br>* Lamotrigine<br>Drug: GI267119<br>* 25 mg ODT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lamotrigine AUC(0-inf) and Cmax |  | Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax and t1/2, Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rateTime points |  | throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tolerability, safety, Pharmacokinetic characteristics
Effect of EGb 761® on Patients With Mild to Moderate Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to measure the effect of EGb 761® versus placebo on the ratio of the isoform of the protein precursor of beta amyloid platelets, in patients with mild to moderate Alzheimer's disease.

Official Title
-----------------
Effect of EGb 761® on the Ratio of the Isoforms of the Protein Precursor of Beta Amyloid Platelets on Patients With Mild to Moderate Alzheimer's Disease. A Phase II, Randomised, Double-blind Trial, on Parallel Groups Versus Placebo.

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

Intervention / Treatment
-----------------
* Drug: EGb 761® (Tanakan®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female or male of 50 to 85 years old with a care giver Mini Mental Status (MMS) test between 16 to 26 inclusive Clinical Dementia Rating (CDR) test inferior or equal to 1 National Institute of Neurological and Communicative Disorders and Stroke / Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) test positive for an Alzheimer's disease Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) test positive for dementia Exclusion Criteria: patient already treated by medicines which could interfere with the study low level of vitamin B12 and folate which are considered as clinically relevant clinically relevant pathologies (eg: pulmonary illness, cardiovascular illness; evolutive cancer, neurological illness, blood illness….)

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EGb 761® (Tanakan®)<br>EGb 761® (Tanakan®) | Drug: EGb 761® (Tanakan®)<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Drug: EGb 761® (Tanakan®)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of EGb 761® on the ratio of the isoform of the protein precursor of beta amyloid platelets. |  | Every visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of EGb 761® on the cognitive functions and safety of EGb 761® at a dosage of 240 mg per day |  | Every visit |
Observance of Long Term Oxygen Therapy in Chronic Inspiratory Disease Patients

Study Overview
=================
Brief Summary
-----------------
Long-term oxygen therapy (LTOT) is the reference treatment for chronic respiratory failure. This treatment is based on the principle of oxygen supplementation via a source to correct hypoxemia in patients. At present, adherence to this treatment is difficult to evaluate (reporting by patients), but the results of the literature show poor LTOT compliance. It is therefore important to accurately measure the oxygen consumption by patients and to understand the factors explaining LTOT compliance. The ultimate aim is to improve our patient management to make them more observant in order to improve the therapeutic efficacy of the treatment.

Official Title
-----------------
Observance of Long Term Oxygen Therapy in Chronic Inspiratory Disease Patients

Conditions
-----------------
Chronic Respiratory Disease, Hypoxemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic respiratory disease patients with chronic hypoxemia First prescribed long term oxygenotherapy Exclusion Criteria: patients with NIV and CPAP vital pronostic < 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| oxygen use | time of oxygen use | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory disease severity based on GOLD standards |  | baseline | 
| quality of life assessed by a questionnaire (VQ-11) |  | baseline, 3 month and 6 month | 
| precarity score assessed by a questionnaire (EPICE) |  | baseline |
Prevention of Adhesions During Celioscopy for Endometriosis. Impact of the Use of Anti-adhesion Treatment on Clinical Signs and Fertility at One Year

Study Overview
=================
Brief Summary
-----------------
Thus is a longitudinal, prospective, multicentric observational study performed in mainland France, among a sample of gynaecology surgeons practising at endometriosis expert centres. The aim of this study is to describe, under real treatment conditions in patients suffering from endometriosis, the impact of the use of anti-adhesion treatment during celioscopy surgery on the development of clinical signs in the patients and their fertility at one year.

Official Title
-----------------
Prevention of Adhesions During Celioscopy for Endometriosis. Impact of the Use of Anti-adhesion Treatment on Clinical Signs and Fertility at One Year

Conditions
-----------------
Endometriosis, Adhesive

Intervention / Treatment
-----------------
* Device: Coelioscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients of procreation age and who have undergone treatment for endometriosis through celioscopic surgery. Patients for whom spontaneous pregnancy is possible, whether or not they wish to become pregnant immediately. Patients accepting and able to update a questionnaire in French. Informed patients who agree to computerised processing of their medical data and their right of access and rectification. Exclusion Criteria: Patients for whom a medical assistance programme for procreation (IVF, artificial insemination) is currently in progress. Patients presenting with an absolute or relative contra-indication for use of an anti-adhesion agent (severe allergic antecedents etc). Patients not wishing to become pregnant. Patients participating or having participated during the previous month in a gynaecological clinical trial.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Coelioscopy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on the clinical signs | The clinical change will be established after one year via the pain symptomatology reported by the patient, the rate of relapse (re-hospitalisation) and the rate of any eventual complications from the celioscopy (adhesions, etc.). | At 2 months and one year after the baseline visit (i.e. celioscopy) | 
| Fertility | rate of pregnancy women | One year after the baseline visit (i.e. celioscopy) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coelioscopy
Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients

Study Overview
=================
Brief Summary
-----------------
The study is a two-part small scale, open-label, pilot study to evaluate feasibility and proof-of-concept for a respiratory assist medical device. The study population will consist of severe Chronic Obstructive Pulmonary Disease (COPD) subjects.

Official Title
-----------------
Pilot, Single Center Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients

Conditions
-----------------
COPD, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Device: AIR-AD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Moderate to severe COPD (by ATS criteria) FEV1/FVC <0.70 FEV1 < 60% Predicted Exclusion Criteria: Physical limitation that prevents walking for 6 minutes (e.g. lower extremity amputation, arthritis limiting function, significant angina, etc…) Lung pathology not explained by COPD, which may limit functional capacity (e.g. pulmonary fibrosis, malignancy, history of lung reduction surgery, etc…) Pregnancy Age <18

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 |
| --- | --- |
| Experimental: Part 1: Feasibility<br>Patients will perform 6-minute walk test with AIR-AD to allow for observation and real-time feedback. | Device: AIR-AD<br>* Non-significant risk medical device as decided by institutional review board<br>|
| Experimental: Part 2: Crossover<br>Crossover design where investigator will compare wearing of AIR-AD during exercise to compare distance walked with and without it. | Device: AIR-AD<br>* Non-significant risk medical device as decided by institutional review board<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess distance travelled during 6-minute walk tests performed with and without device. | Distances travelled during two six minute walk tests will be measured. Investigator will compare distance travelled with use of the device to the distance travelled without the use of the device. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess for patient improvement in shortness of breath scores | This will be be measured via survey tool Borg Scale of Dyspnea (0 - no dyspnea, through 10 - maximal dyspnea). Patient scores will be measured during exercise testing with and without the device. Improvement will be considered a lower score on the Borg Scale. | 6 months |
Effect of Vit D on New-onset AF in Hypertension

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation (AF), an important cause of cardiac mortality and morbidity is the most common type of cardiac arrhythmia in clinical practice. Hypertensive individuals are at particular risk of development of atrial fibrillation. Renin-angiotensin-aldosteron system (RAS) which is activated in hypertension may be the underlying mechanism of AF among hypertensive patients. Vitamin D deficiency has been shown to be involved in the pathogenesis of hypertension, cardiovascular disease and obesity. Increased RAS activity is one of the postulated mechanisms by which vitamin D deficiency may trigger the development of hypertension and various cardiovascular diseases. On the basis of these data we hypothesized that hypovitaminosis D might be associated with new-onset AF among patients with hypertension.

Official Title
-----------------
Relation of Low Vitamin D Levels and New-onset AF Among Hypertensive Patients

Conditions
-----------------
Atrial Fibrillation, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertensive patients with new-onset AF Exclusion Criteria: Established coronary artery disease Heart failure Chronic obstructive pulmonary disease Diabetes mellitus Significant heart valve disease Hyperthyroidism Renal failure Any malignancy Acute infection Recent thoracic or abdominal surgery Under therapy of Vit D3

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 |
| --- | --- |
| New onset Atrial fibrillation<br>New-onset AF was defined as patients with hypertension and atrial fibrillation which was identified for the first time by an electrocardiogram or ambulatory holter monitoring. | |
| control<br>Hypertensive patients without atrial fibrillation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypovitaminosis D | Identifying whether hypovitaminosis D is a risk factor for development of new-onset AF among hypertensive patients | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, hypertension, vitamin D
Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether lengthening of both the tibiae and femora in achondroplastic patients is safe and provides reproducible outcome.

Official Title
-----------------
Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients

Conditions
-----------------
SHOX Gene With Short Stature

Intervention / Treatment
-----------------
* Procedure: Lengthening over nail


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Achondroplasia, first lengthening period Exclusion Criteria: Previous lengthening

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 11 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 |
| --- | --- |
| Other: Achondroplasia lengthening<br> | Procedure: Lengthening over nail<br>* External fixator is used to lengthen either the femur or the tibia over an intramedullary nail<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paley's functional scoring system | Paley's functional scoring system evaluates the results after lengthening or deformity correction procedures: residual limb length discrepancy, any brace or other aid usage, joint contracture, pain, soft tissue dystrophism | Minimum 2 year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lengthening
Efficacy and Safety Study of SUNPG1622

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Efficacy and Safety of Tildrakizumab in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis

Conditions
-----------------
Active Ankylosing Spondylitis or Non-Radiographic Axial Spondyloarthritis

Intervention / Treatment
-----------------
* Drug: SUNPG1622 I dose
* Drug: Placebo dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has provided informed written consent Subject is ≥ 18 years of age at time of Screening Subject must be on a stable dose of NSAID for ≥ 2 weeks prior to initiation of investigational product Subject has a negative test for TB within 4 weeks before initiating IMP Exclusion Criteria: Subjects with known diagnosis of fibromyalgia or complex regional pain syndromes Active uveitis or symptomatic inflammatory bowel disease requiring therapy at screening Radiographic evidence of total ankylosis of the spine Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pre-treatment condition

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SUNPG1622 I<br>SUNPG1622 I dose | Drug: SUNPG1622 I dose<br>* Injection<br>|
| Placebo Comparator: Placebo<br>Placebo dose | Drug: Placebo dose<br>* Injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of SpondyloArthritis International Society 20 Response Rates | Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The results for this endpoint is as per the Cochran-Mantel-Haenszel Analysis of ASAS20 Response Rates (Full Analysis Set). | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of SpondyloArthritis International Society 20 Response Rates | Percentage of subjects who achieve improvement of ≥ 40% and absolute improvement of ≥ 20 units from baseline in a visual analog scale (0 [no disease activity]-100 [high disease activity]). The following are the specific time points at which the outcome measure was assessed and for which data are presented : Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. | Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
Test-Retest Reliability in DETECT

Study Overview
=================
Brief Summary
-----------------
Healthy volunteers without concussion, currently participating in non-or-limited contact sports teams at Emory University will undergo Display Enhanced Testing for Concussion and mild traumatic brain injury (mTBI) (DETECT) on three separate days: at baseline, day 50, and day 90. Prior to enrollment participants will be allocated to the test-retest arm or the exercise arm.

Official Title
-----------------
Test-Retest Psychometrics of a Novel Neuropsychological Assessment Tool: Reliability Measures for DETECT

Conditions
-----------------
Reliability Properties of a Concussion Screening Tool

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > or = 16 eligible for active participation during the National Collegiate Athletic Association (NCAA) season or member of the 2011 - 2012 or 2012-2013 club team Participation in a non or minimal contact sport Exclusion Criteria: < age 16 history of concussion in the previous 6 months any of the following: learning disabilities, attention deficient disorder, attention deficit hyperactivity disorder, depression or other psychiatric disorder, sleep apnea, seizure disorder, migraine headaches, previous central nervous system (CNS) surgery chronic drug or alcohol use; or drug or alcohol use with the previous 24 hours inability to complete the study protocol (90 days)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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 |
| --- | --- | --- |
| Primary Objective is to assess the reliability of the DETECT cognitive assessment tool, as measured by changes in DETECT scores from baseline in non-injured athletes. | Subjects will complete the DETECT cognitive assessment tool at Baseline, 50 days, and 90 days. | 90 days |