linjc16/ctgov huggingface dataset:
Vitamin D Treatment for Crohn´s Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether vitamin D treatment is effective in Crohn's disease.

Detailed Description
-----------------
Crohns Disease is an inflammatory disease of primarily the small intestine and colon. In recent years scientists have hypothesized that low blood vitamin-D levels play a role in the development of autoimmune diseases, including Crohns disease. The purpose of this study is to examine whether vitamin-D is effective in keeping remission in inactive Crohns Disease (double blind placebo controlled trial). The patients who have active disease in the placebo group (reach primary endpoint), will in an open setting receive a higher single dose vitamin-D and the effect will be measured within 4 weeks.

Official Title
-----------------
Remission Keeping and Remission Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell Immunomodulation

Conditions
-----------------
Crohns Disease

Intervention / Treatment
-----------------
* Drug: Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Crohn's disease Inactive Crohn's disease for at least 4 weeks Crohn's Disease Activity Index (CDAI) < 150 C-reactive protein within normal range Serum albumin within normal range Exclusion Criteria: Hypercalcemia Short bowel syndrome Pregnancy

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vitamin D|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse rate within 1 year treatment; CDAI>220 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Crohns Disease
Contribution of Ultrasonography in the Evaluation of Cervical Induction-delivery Time

Study Overview
=================
Brief Summary
-----------------
Study of the contribution of ultrasound measurements of the uterine cervix related to the calculation of Bishop score. Evaluation of the period between cervical induction and delivery. Study of ultrasound data to improve the care of these patients requiring induction.

Official Title
-----------------
Apport de l'échographie du Col Dans l'évaluation du Délai Induction Accouchement (DIA) Chez Des Patientes à Score de Bishop défavorable après déclenchement Par Dinoprostone Intravaginal

Conditions
-----------------
Delivery Uterine, Birth; Induced

Intervention / Treatment
-----------------
* Device: Ultrasonography of the cervix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Single pregnancy to term (> 37 weeks) in cephalic presentation Bishop score on the day of inclusion equal to 4.5 or 6 Medical indication in accordance with professional recommendations of the April 2008 HAS. Exclusion Criteria: Cicatricial uterus Placenta previa Parity > 3 (more than 3 previous deliveries > 22 weeks) History of cone biopsy and strapping Known fetal malformation Known allergy to prostaglandins Woman under guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Observational cohort of patients<br>Patients will benefit from an ultrasonography of the cervix through endovaginal before induction of prostaglandins | Device: Ultrasonography of the cervix<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in hours between induction of prostaglandins and delivery | Delivery whether a vaginal delivery or cesarean | On the day of inclusion after induction of prostaglandins. In relation to the time of delivery. |
A Study to Evaluate Safety, Tolerability, and PD of Tegoprazan on Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
A randomized, open-label, active-controlled, multiple dose phase 1 clinical trial to evaluate safety, tolerability, and pharmacodynamics of tegoprazan after oral administration in healthy male volunteers

Detailed Description
-----------------
To compare the pharmacodynamics of multiple oral dose of tegoprazan versus the pharmacodynamics of multiple oral dose of comparator drug in healthy male volunteers. To evaluate the safety and tolerability of multiple oral dose of tegoprazan in healthy male volunteers.

Official Title
-----------------
A Randomized, Open-label, Active-controlled, Multiple Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, and Pharmacodynamics of Tegoprazan After Oral Administration in Healthy Male Volunteers

Conditions
-----------------
Pharmacodynamics, Healthy Male Volunteers

Intervention / Treatment
-----------------
* Drug: Tegoprazan
* Drug: Revaprazan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult males aged ≥ 19 years and ≤ 50 years Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening Exclusion Criteria: Presence or history of clinically significant diseases Presence or history of gastrointestinal disorder (gastric ulcer, GERD, Crohn's disease, etc.) Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity Serologic test positive Abnormal obstacle to insertion and maintenance of pH meter catheter History of drug abuse Excessive caffeine intake or persistent alcohol intake Not use of a medically acceptable method of contraception

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tegoprazan(Test drug)<br>Tegoprazan drug QD for 7 days | Drug: Tegoprazan<br>* Tegoprazan QD for 7 days<br>|
| Active Comparator: Active comparator drug<br>Active comparator drug QD for 7 days | Drug: Revaprazan<br>* Revaprazan QD for 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric pH | Gastric pH | up to 7 days | 
| Serum gastrin concentration | Serum gastrin concentration | up to 9 days |
Effects of Hyperprolactinemia Induced by Antipsychotic Drugs on Bone Metabolism

Study Overview
=================
Brief Summary
-----------------
The study is aimed to assess the severities of hyperprolactinemia caused by antipsychotic drugs and the effects of the duration of hyperprolactinemia on bone metabolism in schizophrenia patients.

Detailed Description
-----------------
Hyperprolactinemia is a common adverse effect of antipsychotic drugs. Studies have shown that hyperprolactinemia may affect bone metabolism through direct and indirect effects and increase the risk of osteoporosis and fracture.The investigators assess the duration, the severity of hyperprolactinemia and its effects on bone metabolism in schizophrenics taking antipsychotic drugs through analyzing the correlation between prolactin levels and biochemical markers of bone metabolism and the correlation between the duration of hyperprolactinemia and abnormal bone metabolism. Meanwhile, the investigators aims to obtain the boundary value of prolactin levels in patients with abnormal bone metabolism.

Official Title
-----------------
Effects of Hyperprolactinemia Induced by Antipsychotic Drugs on Bone Metabolism

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Diagnosis of the disease meets the ICD-10 diagnostic criteria for schizophrenia 2. Subjects Intend to use atypical antipsychotics 3. Age between 18 and 50 years of age Exclusion Criteria: 1. Pregnant and breast feeding women 2. Abnormal lipid metabolism 3. The level of serum alanine aminotransferase or aspartate aminotransferase is two times higher than the upper limit of the normal 4. Patients with diabetes or impaired fasting glucose 5. The level of prolactin is higher than normal 6. Patients taking drugs that affect bone metabolism (e.g. selective serotonin reuptake inhibitors antidepressants, antiepileptic drugs) 7. The level of creatinine is 1.2 times higher than the upper limit of the normal value

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| Bone turnover biochemical markers | changes in the level of serum bone alkaline phosphatase ,serum β-crosslaps and from baseline to 4, 8, 12 and 26 weeks after enrollment | baseline ,4 weeks ,8 weeks，12 weeks and 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum prolactin | changes in the level of serum prolactin from baseline to 4, 8, 12 and 26 weeks after enrollment | baseline ,4 weeks ,8 weeks，12 weeks and 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antipsychotic drugs, hyperprolactinemia, bone metabolism
Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation via different injection routes in patients with treatment-naive sub-foveal choroidal neovascularization secondary to age-related macular degeneration.

Official Title
-----------------
A Phase 1/2, Randomized Clinical Study to Assess the Safety and Efficacy of Sirolimus in Patients With Newly Diagnosed, Treatment-Naive Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Conditions
-----------------
Age-related Macular Degeneration, Choroidal Neovascularization

Intervention / Treatment
-----------------
* Drug: Sirolimus
* Drug: Sirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria include, but are not limited to: Diagnosed with sub-foveal choroidal neovascularization secondary to age-related macular degeneration Visual acuity of 20/50 to 20/200 in study eye Exclusion Criteria: Any other ocular disease that could compromise vision in the study eye History of any prior treatment for choroidal neovascularization in the study eye Presence of other causes of choroidal neovascularization other than secondary to 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Sirolimus<br>* Three subconjunctival injections of 1320 micrograms sirolimus each.<br>* Other names: MS-R002, rapamycin;|
| Experimental: 2<br> | Drug: Sirolimus<br>* Three intravitreal injections of 352 micrograms sirolimus each.<br>* Other names: MS-R001, rapamycin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity by ETDRS |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity by ETDRS |  | 60 days, 120 days | 
| Safety across injection routes |  | Through 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wet AMD, CNV
A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo

Study Overview
=================
Brief Summary
-----------------
A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.

Official Title
-----------------
Multi-Center, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Dosing With Oxybutynin Topical Gel to Treat the Symptoms of Overactive Bladder With a 14-Week Open-Label Safety Extension

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: Oxybutynin topical gel
* Other: Placebo topical gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females and males, 18 years of older with overactive bladder symptoms Exclusion Criteria: Treatable conditions that may cause urinary incontinence Medical conditions in which it would be unsafe to use an anti-cholinergic agent. The use of concomitant drugs that would confound the efficacy evaluation. The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxybutynin topical gel<br>Oxybutynin topical gel | Drug: Oxybutynin topical gel<br>* 1 application daily to skin for 12 weeks<br>* Other names: Oxybutynin;|
| Placebo Comparator: Placebo topical gel<br>placebo topical gel | Other: Placebo topical gel<br>* 1 application daily to skin for 12 weeks<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Average Number of Daily Incontinence Episodes | Average number of daily incontinence episodes at baseline | Baseline | 
| Change From Baseline in Average Daily Number of Incontinence Episodes | Change from Baseline to Week 12 in average daily number of incontinence episodes | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Average Daily Urinary Frequency | Number of daily urinary voids | Baseline | 
| Change From Baseline in Average Daily Urinary Frequency | Change from baseline in average daily urinary frequency | Baseline to 12 weeks | 
| Baseline Average Urine Void Volume | Baseline average urine void volume | Baseline | 
| Change From Baseline in Average Urine Void Volume | Change from baseline to Week 12 in average urine void volume | Change from Baseline to Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OAB, anticholineric, oxybutynin, urge urinary incontinence
Identification of New Genetic Markers for the Risk of Recurrence of Venous Thromboembolism by Whole Genome Analysis

Study Overview
=================
Brief Summary
-----------------
Venous thromboembolism (VTE) is a common and potentially fatal pathology in France. The risk of recurrence is around 5 to 7% per year. The identification of patients at risk of VTE and its prevention is a real health issue in particular. 50% of MTEV recurrences occur in the absence of a risk situation, suggesting the involvement of specific risk factors for MTEV recurrence that have not been identified to date. In the last ten years, so-called genome-whole or genome wide association (GWAS) approaches have identified new genetic risk factors for the first episode of VTE. On the other hand, no study has focused on the predictive factors of recurrence. The previous project, conducted from 2012 (NCT02904967), had as its main objective to identify new genes for susceptibility to MTEV recurrence by comparing cases of MTEV recurrence versus controls having had a single episode of MTEV. The MARTHA cohort (1,542 patients) is extremely valuable study material and is one of the few cohorts in the world with genome-wide data in the field of VTE. Follow-up could only be performed in 359 patients, 76 (21%) of whom presented with a new episode of VTE. The objective of this project is to increase the number of patients for whom the investigators will have information on recurrence / non-recurrence of VTE, by querying national registries on the vital status of patients, and possible causes of death. . These new data on the occurrence or not of a new thrombotic episode, will be confronted with the genetic data already available in all the patients in order to identify specific genetic risk factors and potentially predictive of the recurrence of MTEV.

Official Title
-----------------
Identification of New Genetic Markers for the Risk of Recurrence of Venous Thromboembolism by Whole Genome Analysis: Case-control Study Nested in the MARTHA Cohort

Conditions
-----------------
Venous Thromboembolism (VTE)

Intervention / Treatment
-----------------
* Other: vital status determination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients of the MARTHA cohort Exclusion Criteria: none

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 |
| --- | --- |
| patients with Venous thromboembolism (VTE)<br> | Other: vital status determination<br>* consultation of national registries<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MTEV recurrence | information on recurrence / non-recurrence of VTE, by querying national registries on the vital status of patients, and possible causes of death. | 12 months |
Optimizing Cardiac Resynchronization

Study Overview
=================
Brief Summary
-----------------
Cardiac resynchronization therapy shows great promise as a method to improve ventricular function in heart failure due to dilated cardiomyopathy. It is applied to patients with class III and IV symptomatic heart failure on optimal therapy. Typical entry criteria in the trials testing resynchronization have used the electrocardiogram and a prolonged electrocardiogram (ECG) QRS interval as criteria for dyssynchrony. This is recognized to be quite limited as a tool for identifying patients. Several new echocardiographic methods for identifying dyssynchrony have been proposed. The purpose of this study is to systematically examine these multiple echocardiographic measurement techniques in three conditions: in the patient's native rhythm simulated by changing the pacing system to atrial pacing only; in conventional dual chamber pacing (DDD mode); and during biventricular pacing. All patients entered into this study will already have had a biventricular pacemaker placed.

Official Title
-----------------
Optimizing Cardiac Resynchronization

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

Intervention / Treatment
-----------------
* Procedure: Cardiac resynchronization pacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who have previously had a resynchronization pacemaker system placed at the University of Wisconsin Hospital or at the Middleton Veterans Hospital are potentially eligible for this study. The study is only open to patients as enumerated above, and also patients who have good imaging windows.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cardiac resynchronization pacing|various pacemaker modes used over 1 hour|

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
-----------------
Heart Failure, Cardiac resynchronization, echocardiography