linjc16/ctgov huggingface dataset:
A 14-Day Study of Racivir When Used in Combination in HIV-Infected Males

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate Racivir. The safety, most effective dosage, and how the body reacts to Racivir will be studied.

Detailed Description
-----------------
The study is a 14-day study with a 21-day follow-up period. During the 14-days of active study period, participants will receive Racivir once daily in combination with efavirenz and stavudine. Following the administration of the first and last dose of study medication, patients will remain in the clinic overnight. During the study there will be medical and medication histories taken, physical examinations, vital sign measurements, EKGs, and routine clinical laboratory tests.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Racivir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Subjects may be eligible to participate if they: Are males with HIV infection with a positive HIV antibody test Have an HIV-RNA copy number of ≥ 5000 copies/ml (Roche assay) Have CD4+ cell counts ≥ 50 cells/ml Are 18-45 years of age, inclusive Have a body mass index (BMI) ≥ 18 kg/m2 Are antiretroviral nucleoside reverse transcriptase inhibitor-naive Have read and understand the informed consent,and is able and willing to comply with study procedures Exclusion Criteria Subjects may not participate if they: Have clinically significant ECG abnormalities Have clinically significant abnormalities in any safety laboratory parameters Have an ALT value ≥ 3xUNL Have previously participated in this trial Have participated in another trial of an investigational drug within the last 3 months or are currently participating in another trial of an investigational drug Have a history of chronic alcohol or drug abuse within the last 6 months Have a positive urine drug screening Have a positive alcohol breath test Have any medical or psychiatric condition, which in the opinion of the investigator would jeopardize or compromise the subject's ability to participate in this trial Have a known hypersensitivity to any components of the trial medication or comparative drugs as stated in this protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Racivir|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
-----------------
treatment experienced, HIV, Phase I, Combination Therapy
Dijon Stroke Cohort

Study Overview
=================
Brief Summary
-----------------
The Dijon Stroke Registry, accredited by the Registry Evaluation Committee, INSERM and Public Health France, has been studying the epidemiology of cerebrovascular accidents (cerebral infarction, intracerebral haemorrhages, meningeal haemorrhages) and transient ischaemic attacks (TIAs) within the city of Dijon since 1985. As a result of the development of therapies for acute disease, the prognosis of patients has improved over time. Thus, the number of stroke survivors has increased by 90% between the 1980s and today. This raises new issues: risk of vascular recurrence, drug iatrogeny, and functional impact of stroke for motor, cognitive or thymic function. In the absence of available data in France, the investigators wish to set up an extended cohort follow-up of patients in order to study their long-term prognosis and to study the impact of future therapies on the evolutionary course of the disease.

Official Title
-----------------
Dijon Stroke Cohort

Conditions
-----------------
CVA, Dijon Registry

Intervention / Treatment
-----------------
* Other: Questionnaire and semi-structured interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients included in the Dijon Stroke Registry and not opposed to participating Exclusion Criteria: minor patients; opposition to participation

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 |
| --- | --- |
| Stroke patient<br>Patient included in the Dijon Stroke Registry. | Other: Questionnaire and semi-structured interview<br>* questionnaire submitted by telephone 3 months, 6 months, 1 year, 5 years, and 10 years after the stroke/TIA. interview duration 20 to 40 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death rate |  | Trough study completion, an average of 10 years | 
| Disability rate |  | Trough study completion, an average of 10 years | 
| Quality of Life Questionnaire |  | Trough study completion, an average of 10 years | 
| Neuropsychological questionnaire |  | Trough study completion, an average of 10 years |
LANCGMS - Lantus Continuous Glucose Monitoring Subcutaneous

Study Overview
=================
Brief Summary
-----------------
Comparison of incidence of hypoglycaemic events and glycaemic fluctuations in diabetic patients with basal substitution with NPH insuline versus insuline glargine. Evaluation of HbA1c, FBG (Fasting Blood Glucose), BMI (Body Mass Index), dose of insulin, ratio of basal and prandial insulin, satisfaction with treatment, incidence of adverse events.

Official Title
-----------------
Comparison of Glycaemic Fluctuations During 3 Days Subcutaneous Continuous Monitoring in Patients With Basal Substitution Human Insulin NPH vs Insuline Glargine

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: insulin glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Diabetes Mellitus Type 1 and Diabetes Mellitus Type 2 with HbA1c 6% and more with more than 2 confirmed hypoglycaemic events (glycaemia less than 3,3 mmol/l) during last year Exclusion Criteria: Diabetic ketoacidosis Any other severe disease Pregnancy or fertile female without contraception Alcohol/drug abuse, selected prohibited concomitant medication Nightshift work

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin glargine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 days continual glycaemic profile fluctuation |  |  | 
| occurrence of adverse events |  |  | 
| HbA1c |  |  | 
| FBG |  |  | 
| BMI |  |  | 
| total daily dose of insulin and ratio of doses of basal/prandial insulines |  |  | 
| patients´satisfaction |  |  |
Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses

Study Overview
=================
Brief Summary
-----------------
Comparison of postoperative patient's joint awareness as well as clinical and radiological outcomes between fixed- and mobile-bearing total knee arthroplasty of which the prosthesis is coated with Titanium-nitride.

Detailed Description
-----------------
Despite numerous comparison studies between mobile- and fixed-bearing TKA as well as several comparison studies regarding clinical and radiological outcomes using titanium-nitride(TiN) prosthesis, there has been no study on postoperative joint awareness despite mobile- and fixed-bearing TKA using TiN prosthesis.

Official Title
-----------------
Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses

Conditions
-----------------
Osteoarthritis, Knee, Arthropathy of Knee, Joint Awareness

Intervention / Treatment
-----------------
* Device: Fixed-bearing TKA
* Device: Mobile-bearing TKA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with knee joint advanced osteoarthritis Age over 55 years old Scheduled to undergo primary total knee arthroplasty Exclusion Criteria: Post-traumatic or inflammatory osteoarthritis Those who undertook previous ligamentous surgery Those who do not understand and give answers to a survey

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fixed-bearing group<br> | Device: Fixed-bearing TKA<br> <br> |
| Experimental: Mobile-bearing group<br> | Device: Mobile-bearing TKA<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forgotten joint score | Questionnaire of evaluating how much the patients are aware of their operate joint during daily activities. The higher, the worse. Range: 0-100 | Postoperative 3 years | 
| Crepitus | Any grating, crackling or popping sensation around knee when moving a joint | Postoperative 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forgotten joint score | Questionnaire of evaluating how much the patients are aware of their operate joint during daily activities. The higher, the worse. Range: 0-100 | Postoperative 5 years | 
| Crepitus | Any grating, crackling or popping sensation around knee when moving a joint | Postoperative 5 years |
MSI-1256F (Squalamine Lactate) in Combination With Verteporfin in Patients With Wet Age-Related Macular Degeneration (AMD)

Study Overview
=================
Brief Summary
-----------------
Age-Related Macular Degeneration (AMD) is a degenerative disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - dry and the more severe wet form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine when administered with verteporfin therapy in patients with wet AMD.

Official Title
-----------------
Safety and Efficacy of MSI-1256F (Squalamine Lactate) in Combination With Verteporfin in Patients With Wet Age-Related Macular Degeneration (AMD)

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: MSI-1256F (Squalamine Lactate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of wet age-related macular degeneration Exclusion Criteria: Prior treatment for wet age-related macular degeneration

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MSI-1256F (Squalamine Lactate)|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
-----------------
Age-Related Macular Degeneration - Wet Type
A Comparison of Subvastus and Midvastus Approaches in Minimally-Invasive Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the early clinical outcomes of minimally invasive bilateral subvastus and midvastus approaches for total knee arthroplasty.

Official Title
-----------------
A Comparison of Subvastus and Midvastus Approaches in Minimally-Invasive Total Knee Arthroplasty

Conditions
-----------------
Total Knee Arthroplasty

Intervention / Treatment
-----------------
* Procedure: mini-midvastus surgical approach for total knee arthroplasty
* Procedure: mini-subvastus surgical approach for total knee arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with advanced bilateral osteoarthritis of the knee for treatment with total knee arthroplasty patients who wish to undergo bilateral total knee arthroplasty as part of a single surgical procedure Exclusion Criteria: patients who were previously treated with knee arthroplasty

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mini-midvastus<br> | Procedure: mini-midvastus surgical approach for total knee arthroplasty<br> <br> |
| Active Comparator: mini-subvastus<br> | Procedure: mini-subvastus surgical approach for total knee arthroplasty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score |  | Final follow-up (minimum 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic alignment and fixation |  | Final follow-up (minimum 24 months) |
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of moderate or severe migraine in children and adolescents (≥ 6 to < 18 years of age).

Official Title
-----------------
Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age

Conditions
-----------------
Acute Treatment of Migraine

Intervention / Treatment
-----------------
* Drug: Rimegepant / BHV3000


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of migraine (with or without aura) for ≥ 6 months before Screening History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment. 1 or more migraine days requiring treatment during the Observation Phase. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit Ability to distinguish between migraine and other types of headaches. Weight ≥ 40 kg at the Screening Visit. Adequate venous access for blood sampling. Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday before enrollment into the study) Exclusion Criteria: History of cluster headache or hemiplegic migraine headache. Confounding and clinically significant pain syndrome Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded). History of suicidal behavior or major psychiatric disorder. Current diagnosis or history of substance abuse; positive drug test at Screening.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rimegepant / BHV3000<br>BHV3000 (rimegepant) 75 mg or 50 mg ODT | Drug: Rimegepant / BHV3000<br>* BHV3000 (rimegepant) 75 mg or 50 mg ODT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of treatment-emergent adverse events, serious adverse events | To evaluate the safety and tolerability of rimegepant in children and adolescents (≥ 6 to < 18 years of age). | 58 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Long-term safety, acute treatment, migraine, phonophobia, photophobia, nausea, pediatric, children, adolescent
Exercise Oscillatory Breathing and Sildenafil in Heart Failure

Study Overview
=================
Brief Summary
-----------------
Exercise oscillatory breathing (EOB) is a ventilatory abnormality that occurs in approximately 20% of heart failure (HF) patients and carries a very unfavourable prognosis. Pathophysiology seems quite complex and putative mechanisms include increased pulmonary capillary pressure and pulmonary vasoconstriction, circulatory blood-flow fluctuations in the pulmonary arterial system and instability of ventilatory control. Inhibition of the phosphodiesterase 5 (PDE5) isoenzyme favourably regulates pulmonary vascular tone and permeability through over signaling of the endothelial nitric oxide pathway. The investigators tested the hypothesis that sildenafil would reverse the EOB pattern in patients with HF and pulmonary hypertension.

Official Title
-----------------
PDE5-Inhibition With Sildenafil Reverses Exercise Oscillatory Breathing in Chronic Heart Failure: a Long-Term Cardiopulmonary Exercise Testing Placebo-Controlled Study

Conditions
-----------------
Heart Failure

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consent to participate in the study after detailed information about benefits and risks negative exercise stress test prior to study initiation forced expiratory volume in 1 sec/forced vital capacity ratio >70%; LVEF < 45%. Exclusion Criteria: inability to complete a maximal exercise test resting systolic blood pressure > 140 or <110 mmHg therapy with nitrate preparations history of sildenafil intolerance significant lung or valvular diseases neuromuscular disorders or peripheral vascular disease

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Control Group | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: sildenafil, pde5 inhibitor<br>treatment group; sildenafil 50 mg three times a day for 1 year | Drug: Sildenafil<br>* Sildenafil, 50 mg 3 times/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Effect on Oscillatory Breathing during Exercise |  | 1 year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PDE5-inhibition, exercise ventilation, heart failure, sildenafil, pulmonary hemodynamics
Physiotherapist Led Group-exercise Compared Physical Activity on Prescription, a 3 Months Follow-up

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of exercise or PAP prescription 3 months after completion of the study Should elderly patients with atrial fibrillation be offered physiotherapist group exercise or can physical activity on prescription (PAP) be used as an alternative? regarding level of physical fitness, physical activity, heart rate and health related quality of life (HR-QoL). Also if any of the investigated variables can predict the possible change in physical fitness.

Detailed Description
-----------------
Patients who have completed study will be offered a follow-up after 3 months regarding physical fitness, physical activity, heart rate and HR-QoL. Physical fitness will be measured by a symptom limited bicycle test and a muscle endurance test. Physical activity will be measured by accelerometer and the International Physical Activity Questionnaire (IPAQ) and a physical activity diary, HR-QoL will be measured by short form (SF-36).

Official Title
-----------------
Physiotherapist Led Group-exercise Compared Physical Activity on Prescription in Older Patients With Atrial Fibrillation, a 3 Months Follow-up

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

Intervention / Treatment
-----------------
* Other: No intervention in the follow up study.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed the study Should elderly patients with atrial fibrillation be offered physiotherapist group exercise or can physical activity on prescription (PAP) be used as an alternative? Exclusion Criteria: Not completed the above study or denied participation in follow up

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 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 |
| --- | --- |
| Exercise group<br>A follow up from 3 months detraining from the exercise group. Patients follows their earlier randomisation. | Other: No intervention in the follow up study.<br> <br> |
| Active Comparator: PAP group<br>A follow up from 3 months detraining from the active comparator group. Patients follows their earlier randomisation. | Other: No intervention in the follow up study.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical fitness | Working capacity in watt | 3 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | accelerometer and questionnaire | 3 months follow up | 
| Health related quality of life | questionnaire short form (SF-36) | 3 months follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Follow up, Exercise, Rehabilitation