linjc16/ctgov huggingface dataset:
Serum Citrate in Diagnosis and Follow-up for Glaucoma

Study Overview
=================
Brief Summary
-----------------
Glaucoma might be a mitochondria associated disease. Since citrate is a major component in mitochondrial metabolism its determination in blood might serve as a biomarker.

Official Title
-----------------
Serum Citrate in Diagnosis and Follow-up for Glaucoma

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

Intervention / Treatment
-----------------
* Procedure: drawing blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age> 18 years glaucoma Exclusion Criteria: Active ocular inflammation Ocular Hypertension Nephropathy Alcohol-, Drug abuse Mitochondriopathy

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>glaucoma patients | Procedure: drawing blood sample<br>* fasting blood sample<br>|
| 2<br>non-glaucoma controls | Procedure: drawing blood sample<br>* fasting blood sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum citrate level |  | 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine citrate |  | 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, citrate
Acute Myocardial Infarction by Penetrating Cardiac Trauma

Study Overview
=================
Brief Summary
-----------------
Patients with a cardiac stab wound could be complicated by a posttraumatic acute myocardial infarction (PAMI). Traditionally, the investigators can explain it by the occlusion of a coronary artery; but the PAMI isn´t constantly related with coronary artery injuries or their damage in the cardiac injury repair. The investigators objectives are to know the PAMI incidence, make an approximation to PAMI pathophysiology, and propose management strategies.

Official Title
-----------------
Relationship of Echocardiographic and Coronary Angiographic Findings in Patients With Acute Myocardial Infarction Secondary to Penetrating Cardiac Trauma

Conditions
-----------------
Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart stab Injury Exclusion Criteria: Previous cardiac injuries, coronary artery disease with previous diagnostic, previous coronary angiography (for any indication)

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 80 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 |
| --- | --- |
| Non infarct<br> | |
| Posttraumatic acute myocardial infarct without coronary injury<br> | |
| Posttraumatic acute myocardial infarct with coronary injury<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic acute myocardial infarct |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic acute myocardial infarct without coronary injury |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart injuries, Posttraumatic myocardial infarction, Echocardiography, Coronary angiography
Effects of Novel Combinations of Tolterodine/Pilocarpine on Pharmacokinetics (PK) and Pharmacodynamics (PD) of Tolterodine in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic agonist (pilocarpine).

Detailed Description
-----------------
Because of the limitations of taking two medications separated by a period of time to minimise these adverse events, two novel formulations were developed to improve compliance and ease of administration. This study will evaluate these formulations in terms of their pharmacokinetic profiles and effects on SSF. In addition, the effects of this combination and its entities on urine frequency and safety/tolerability will be assessed.

Official Title
-----------------
Effects of THVD-201 on Pharmacokinetics and Pharmacodynamics of Tolterodine in Healthy Subjects

Conditions
-----------------
Incontinence

Intervention / Treatment
-----------------
* Drug: Tolterodine
* Drug: Pilocarpine
* Drug: THVD-201
* Drug: THVD-201
* Drug: placebo capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males, 18 - 45 years of age. BMI 20-30 m2. Exclusion Criteria: Subjects who have a history of sensitivity to antimuscarinic or muscarinic agents or related derivatives. Clinically significant ECG, vital signs and clinical laboratory indices.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment B<br>Study drug | Drug: Pilocarpine<br>* Comparison of different dosages of drug<br>|
| Active Comparator: Treatment D<br>Study drug | Drug: THVD-201<br>* Comparison of different dosages of drug<br>|
| Placebo Comparator: Treatment E<br>Placebo | Drug: placebo capsule<br>* Comparison of different dosages of drug<br>|
| Active Comparator: Treatment A<br>Study Drug | Drug: Tolterodine<br>* Comparison of different dosages of drug<br>|
| Active Comparator: Treatment C<br>Study Drug | Drug: THVD-201<br>* Comparison of different dosages of drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reductions in stimulated salivary flow (SSF) |  | From Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the pharmacokinetics of tolterodine and the agonist. |  | From Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tolterodine, Over active Bladder (OAB), Incontinence
Trans-pulmonary Biomarkers in Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
The investigators are testing whether the addition of Pulmonary Hypertension-related biomarkers, measured across the pulmonary circulation, to the standard hemodynamic evaluation for Pulmonary Hypertension will lead to more informed choices of Pulmonary Hypertension therapy and improved patient outcomes.

Detailed Description
-----------------
Eligible participants with known or suspected Pulmonary Hypertension undergoing a clinically indicated right heart catheterization may be enrolled. Clinical data and blood samples will be analyzed.

Official Title
-----------------
Examination of Trans-pulmonary Biomarkers in Pulmonary Hypertension: a Potential Step Towards Personalized Therapy

Conditions
-----------------
Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old Undergoing RHC for PH evaluation Exclusion Criteria: Anemia defined as Hgb < 10 g/dL and HCT < 30 Pregnancy at the time of RHC (as assessed by urine or serum pregnancy test on the day of the procedure) Left ventricular ejection fraction ≤ 40% Atrial fibrillation at the time of RHC (as defined by telemetry monitoring or EKG on the day of the procedure) IPF, CTEPH, COPD/OSA as the dominant etiology of PH Patient is currently taking PH medication or long-acting nitrates at the time of their RHC.

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 |
| --- | --- |
| Pulmonary Hypertension & WHO group I<br>Participants with Pulmonary Hypertension with a WHO classification group I and are scheduled to have a right heart catheterization. | |
| Pulmonary Hypertension & WHO group II<br>Participants with Pulmonary Hypertension with a WHO classification group II and are scheduled to have a right heart catheterization. | |
| Without Pulmonary Hypertension<br>Participants without Pulmonary Hypertension | |
| Connective Tissue Disease<br>Participants without PH, but with connective tissue disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Pulmonary Hypertension biomarkers in patients evaluated for Pulmonary Hypertension |  | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasodilator-induced changes in Pulmonary Vascular Resistance (PVR) |  | At baseline | 
| Vasodilator-induced changes in Pulmonary Hypertension biomarkers |  | At baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Hypertension, biomarker, cardiac, circulation, heart disease, lung disease
Use of Eylea for the Treatment of an Optic Nerve Hemangioma

Study Overview
=================
Brief Summary
-----------------
This is a single patient investigative treatment study. The patient was diagnosed with a retinal tumor in one eye. In the last 2 years, the patient has been treated with all available and conventional therapies, including intraocular injections of Avastin and Lucentis, steroids, and photodynamic therapy. Any positive results were short-term, and caused an eventual decline in central vision. Aflibercept has been shown to be effective against the growth of new vessels, secondary to macular degeneration. This study proposes that it may also be more effective in treating this particular patient and case. The study treatment plan is for 6 months initially, with the intention to continue treatment.

Detailed Description
-----------------
The treatment plan will be to administer aflibercept 2.0 mg intravitreally every two to four weeks for at least six consecutive injections. Prior to initiation of therapy and at each study visit, a full ophthalmic examination, best-corrected visual acuity, and a complete review of systems to monitor for any toxicity will be performed. In addition, the investigators will perform fluorescein and indocyanine green angiography at baseline and obtain color fundus photographs as well as spectral domain OCT images to properly document the extent and degree of activity of the vascular tumor at baseline and at all study visits.

Official Title
-----------------
Use of Eylea for the Treatment of an Optic Nerve Hemangioma

Conditions
-----------------
Retinal Hemangioma

Intervention / Treatment
-----------------
* Drug: Aflibercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: retinal hemangioma previously treated with conventional therapies, including Avastin, Lucentis, steroid, and photodynamic therapy, with less than ideal results Exclusion Criteria: ongoing reevaluation of adverse events, including inflammation, elevated intraocular pressure, or any suspected toxicity from aflibercept

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aflibercept|2.0 mg Intravitreal Injection, every 2 to 4 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of the Performance of Self-monitoring Optimized by Therapeutic Education in the Recurrence of Wet Age-related Macular Degeneration (AMD)

Study Overview
=================
Brief Summary
-----------------
Monocentric and prospective study, evaluating the benefit of self-monitoring optimized by therapeutic education either by the environmental Amsler or the Amsler grid according to the patient's choice and to determine the patient's ability to determine the reality itself recidivism and therefore the need for treatment.

Official Title
-----------------
Evaluation of the Performance of Self-monitoring Optimized by Therapeutic Education in the Recurrence of Wet Age-related Macular Degeneration (AMD)

Conditions
-----------------
Age-related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Affiliation to a social security scheme Patient agreeing to participate in the process of therapeutic education. Centrofoveal fixation with visual acuity> 2/10 Antecedent of at least one recurrence so that the patient is aware of the notion of recurrent chronic disease Intravitreal injection antecedent less than 6 months ago Exclusion Criteria: Vulnerable people Majors subject to legal protection or unable to express their consent Arterial emboli disorders of less than three months such as myocardial infarction, stroke

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |
| Sensitivity and specificity of self-monitoring by the environmental Amsler or the clinical Amsler grid according to the choice of the patient after therapeutic education. | Sensitivity and specificity of self-monitoring by the environmental Amsler or the clinical Amsler grid according to the choice of the patient after therapeutic education. | Through study completion, on average of 1 year |
Relationship of Obesity With GERD Among Nigerians

Study Overview
=================
Brief Summary
-----------------
Obesity is a strong risk factor for GERD. This study assessed the role of obesity among patients having erosive GERD and controls.

Detailed Description
-----------------
A case control study of patients with erosive GERD. Patients with erosive GERD who had upper gastro-intestinal endoscopy were graded using the Los Angeles classification. Patients and controls had measurements of body mass index (BMI), WC (waist circumference), Waist hip ratio (WHR), and hip circumference (HC). Bio-data was collected from both groups and data were analysed using descriptive and inferential statistics. A p value of equal to or less than 0.05 was considered significant.

Official Title
-----------------
Relationship Between Body Mass Index, Waist Circumference, Waist Hip Ratio and Erosive Gastroesophageal Reflux Disease in a Tertiary Centre in Nigeria: a Case Control Study

Conditions
-----------------
Gastro-esophageal Reflux Disease With Ulceration.

Intervention / Treatment
-----------------
* Other: Gastroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with dyspepsia Exclusion Criteria: Patients that refused consent. Patients with gastric cancer Patients with gastric outlet obstruction Pregnant women Active gastrointestinal bleeding Cigarette smokers Patients on Naso-gastric tube.

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 |
| --- | --- |
| Erosive GERD<br>Gastroscopy examination. | Other: Gastroscopy<br>* Upper gastrointestinal endoscopy procedure<br>|
| Control population<br>Gastroscopy examination. | Other: Gastroscopy<br>* Upper gastrointestinal endoscopy procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obesity associated with GERD | Measurement of anthropometric indices | Immediate. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index is associated with GERD | Measurement of body mass index (kilogram per meter squared) | Immediate | 
| Waist circumference is associated with GERD | Measurement of waist circumference (centimeter) | Immediate | 
| Waist hip ratio is associated with GERD | Measurement of waist hip ratio | Immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastroesophageal reflux disease, women, Nigeria, obesity
Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin

Study Overview
=================
Brief Summary
-----------------
Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to compare the efficacy and safety of combining fenofibrate and simvastatin versus atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With Atorvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 10 mg Atorvastatin Alone

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: fenofibrate / simvastatin
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mixed dyslipidemia. Exclusion Criteria: Known hypersensitivity to fenofibrates or simvastatin or atorvastatin Pregnant or lactating women Contra-indication to fenofibrate or simvastatin or atorvastatin Unstable or severe cardiac disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: 1<br> | Drug: fenofibrate / simvastatin<br>* Combination of fenofibrate and simvastatin 20 mg and 40 mg<br>|
| Active Comparator: 2<br> | Drug: Atorvastatin<br>* Atorvastatin 10 mg and 20mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 12 weeks of treatment in Triglycerides |  | 12 weeks | 
| Percent change from baseline to 12 weeks of treatment in HDL-C |  | 12 weeks | 
| Percent change from baseline to 12 weeks of treatment in LDL-C |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline to 12 weeks of treatment in Triglycerides |  | 24 weeks | 
| Percent change from baseline to 12 weeks of treatment in HDL-C |  | 24 weeks | 
| Percent change from baseline to 12 weeks of treatment in LDL-C |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin versus atorvastatin
A Trial of the Safety and Efficacy of K-604 for the Treatment of Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of K-604 for the treatment of atherosclerosis.

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Drug: K-604
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate carotid artery stenosis Exclusion Criteria: history of arteritis heavily calcified plaque uncontrolled hypertension poorly controlled diabetes hypercholesterolemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: low dose K-604<br> | Drug: K-604<br>* K-604 is given for 26 weeks<br>|
| Experimental: high dose K-604<br> | Drug: K-604<br>* K-604 is given for 26 weeks<br>|
| Placebo Comparator: placebo<br> | Other: Placebo<br>* placebo tablets are given for 26 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in plaque composition over 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in plaque size over 6 months. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atherosclerosis, carotid artery disease