linjc16/ctgov huggingface dataset:
Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina

Study Overview
=================
Brief Summary
-----------------
Primary: To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients Secondary: To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.

Official Title
-----------------
Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Ramipril-Felodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient Patients who couldn´t control their hypertension after 6 weeks of treatment with monotherapy (calcium blockers, beta blockers, diuretics, ACE inhibitors, AT2 blockers)(uncontrolled hypertension). Exclusion Criteria: Already on fixed-dose combination treatment for hypertension Contraindication to angiotensin converting enzyme (ACE) inhibitors or CCB therapy Known hypersensitivity to felodipine (or other dihydropyridines), ramipril, other ACE or any of the excipients of ramipril felodipine. History of angioedema Unstable haemodynamic conditions: cardiovascular shock, untreated heart failure, acute myocardial infarction, unstable angina pectoris, stroke. Patients with AV block II or III Severely impaired hepatic function. Pre-existing bilateral renal artery stenosis or stenosis of the artery to a solitary kidney Pregnant and lactating mothers Patients on dialysis or haemofiltration. Patients with creatinine clearance < 20ml/min Use of potassium sparing diuretics Severe hypertension (SBP ≥ 180 mmhg or DBP ≥ 110 mmhg) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Ramipril-Felodipine|Ramipril + felodipine 2.5/2.5mg per tablet. One tablet to be taken Od for 8 weeks (this dose could be increased at week 2 to 4 to 5 mg daily because of uncontrolled hypertension).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean changes in Systolic Blood Pressure (SBP) |  | from baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean changes in Diastolic Blood Pressure (DBP) |  | from baseline to Week 8 | 
| Percentage of responders with regard to DBP and SBP |  | comparison to baseline | 
| Adverse events |  | After treatment and at each follow-up visit |
Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
In this study we intend to evaluate the outcome of intravitreal avastin on improving the visual acuity and macular edema and late complications of BRVO like NVD and NVE

Detailed Description
-----------------
After diabetic retinopathy, vein occlusion is the second most common retinovascular disease. According to BVO study the only effective management of it is macular photocoagulation for macular thickening that persist after 3 months.But we may miss a golden time which resulted to photoreceptor degeneration due to macular edema during this period. VEGF inhibitors newly have been shown that may be effective on a wide range of retinovascular diseases that resulted to macular edema or new vessels formation. In this study we aim to show the outcomes of one of this VEGF inhibitors (bevacizumab) on complications of BRVO in a sham controlled clinical trial.

Official Title
-----------------
Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial

Conditions
-----------------
Retinal Disease

Intervention / Treatment
-----------------
* Drug: Avastin (Bevacizumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with acute BRVO with less than three month duration Exclusion Criteria: vision less than 20/320 and vison more than 20/50 duration more than 3 months history of glaucoma and diabetic retinopathy any media opacity that prevent funduscopy

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intravitreal injection of Avastin | Drug: Avastin (Bevacizumab)<br>* Intravitreal injection of 125 mg Avastin<br>|
| Sham Comparator: 2<br> | Drug: Avastin (Bevacizumab)<br>* Intravitreal injection of 125 mg Avastin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity |  | At 12 week | 
| Macular thickness by OCT |  | At 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for macular photocuagulation |  | At 12th week | 
| Incidence of new vessel formation |  | At 12th week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intravitreal Avastin, BRVO, Macular edema
CD16+ Monocytes in Coronary Heart Disease (CHD)

Study Overview
=================
Brief Summary
-----------------
Monocytes may be separated into phenotypically and functionally distinct cell types by the presence or absence of the lipopolysaccharide receptor CD14 and the Fcγ-receptor CD16. The investigators hypothesize that the total numbers of CD16+ monocytes are significantly related to cardiovascular outcome in patients with angiographically proven coronary heart disease.

Official Title
-----------------
CD16+ Monocytes in Patients With Coronary Heart Disease

Conditions
-----------------
Coronary Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: angiographically proven coronary heart disease Age > 18 years Exclusion Criteria: life expectancy < 12 months inability to participate in the trial (to give written informed consent)

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 |
| --- | --- |
| Acute coronary syndrome<br> | |
| Stable Angina<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute numbers of CD16+ monocytes stratified by tertiles related to the incidence of the combined endpoint | Incidence of the combined endpoint (non-fatal myocardial infarction, cardiovascular death, stroke) during a follow-up of 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute numbers of CD16+ monocytes stratified by tertiles related to the incidence of each part of the combined endpoint + total death | non-fatal myocardial infarction cardiovascular death stroke total death | 12 months | 
| Subgroup analysis for absolute numbers of CD16+ monocytes stratified by tertiles in relation to the combined endpoint | Subgroups of patients: Patients with stable Angina Patients with acute coronary syndrome | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
-CD16+ monocytes
Measure of Plasma Tissue Factor to Predict a Venous Thromboembolism in Primitive Cancer of Lung

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate if the plasma activity of the tissue factor at the time of the diagnosis of a lung cancer, before any treatment, or after the treatment of induction (surgery or two first cures of chemotherapy), can be a predictive factor of venous thromboembolism disease in the year which follows the diagnosis, independently of the other parameters.

Official Title
-----------------
Does the Measure of the Plasma Tissue Factor Allow to Predict a Venous Thromboembolism Episode for Patients Presenting a Primitive Lung Cancer?

Conditions
-----------------
Cancer of Lung

Intervention / Treatment
-----------------
* Other: venous thromboembolism


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of more than 18 years old Patients with cancer of lung diagnosis carried for less than 2 months and which were not handled yet, either by surgery or by chemotherapy, or by radiotherapy Patients whose life expectancy is considered 3-month-old a superior Patients having given writed consent Patients affiliated to a national insurance scheme or benefiting from such a diet Patients having received a treatment (processing) anticoagulating in preventive dose if this treatment was stopped at least 3 days before the 1st taking or patients not receiving an anticoagulating treatment (in case of curative treatment, the latter was before arrested at least 3 months Exclusion Criteria: Patients having a hepatic disease with coagulation disorders Patients under anticoagulants with dose guardian in 3 months preceding the study or presenting an active infection Patients having a history of other cancer considered as cured and diagnosed for less than 5 years (with the exception of the patients operated for an in situ carcinoma of the neck of the womb or the patients having undergone the excision of a squamous-cell carcinoma)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cancer of lung<br> | Other: venous thromboembolism<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolism occurence |  | 2 years | 
| Tissue factor | Tissue factor is measured by kinetic-chromogenic assay | 2 years |
COVID-19 Associated Coagulopathy in Egypt

Study Overview
=================
Brief Summary
-----------------
Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and is associated with increased mortality and admission to critical care. Most commonly observed coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive hospitalization reported to have developed disseminated intravascular coagulation (DIC) compared to 0.6% of survivors.

Detailed Description
-----------------
studying the detailed coagulation screen and second line coagulation parameters including both thrombophilia screen and other acute phase coagulation factors.

Official Title
-----------------
Assessment of COVID-19 Associated Coagulopathy and Hypercoagulable State in Upper Egypt

Conditions
-----------------
Coagulopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with COVID 19 positive by RT- PCR Exclusion Criteria: no exclusions
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 |
| --- | --- | --- |
| Coagulation screen | Full coagulation screen | 1 month | 
| Thrombophilia screen | Full thrombophilia screen | 1 month | 
| VWF, FVIII | VWFAg, FVIII | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypercoagulable, COVID-19
Online Psychoeducation for Intolerance of Uncertainty

Study Overview
=================
Brief Summary
-----------------
Randomized control trial examining the efficacy of an online intolerance of uncertainty focused psychoeducation intervention.

Detailed Description
-----------------
Randomized control trial examining the efficacy of an online intolerance of uncertainty (IU) focused psychoeducation intervention among females elevated in IU.

Official Title
-----------------
Online Psychoeducation for Intolerance of Uncertainty

Conditions
-----------------
Intolerance of Uncertainty, Anxiety

Intervention / Treatment
-----------------
* Behavioral: Active IU-focused Psychoeducation Intervention
* Behavioral: Health-focused Psychoeducation Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elevated intolerance of uncertainty at baseline Exclusion Criteria: Patients would be excluded if they endorsed suicidal ideation/intent that required hospitalization.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active IU-focused Psychoeducation Intervention<br> | Behavioral: Active IU-focused Psychoeducation Intervention<br>* This paradigm was an IU-focused psychoeducation intervention wherein participants were provided psychoeducation about the nature of IU and anxiety, given strategies to cope with fear of uncertainty, and provided examples and information as to how they can expose themselves to uncertainty.<br>|
| Active Comparator: Health-focused Psychoeducation Intervention<br> | Behavioral: Health-focused Psychoeducation Intervention<br>* This intervention is a health-focused psychoeducation intervention wherein participants learn ways to engage in healthy behaviors, such as getting adequate sleep, eating healthier, and exercising regularly.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intolerance of Uncertainty (IIU) | Change IU across time | Baseline to one-month follow-up | 
| Beck Anxiety Inventory | Change in beck anxiety inventory scores across time | Baseline to one-month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intolerance of Uncertainty, Anxiety
Exercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement

Study Overview
=================
Brief Summary
-----------------
I. To investigate whether patient characteristics, exercise therapy characteristics, local metabolic exercise response, endothelial function, autonomic function or atherosclerotic lesion location can predict the walking response to a successfully completed semi-supervised exercise intervention in patients with intermittent claudication (WP I) II. To assess the effect of a home-based exercise intervention with remote monitoring and coaching on cardiovascular risk factors in patients with intermittent claudication (WP II)

Official Title
-----------------
Exercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Other: Walking
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
The study population will comprise patients diagnosed with lower-extremity artery disease (ABI ≤0.9 and/or 20% decrease after a maximal treadmill test) suffering from intermittent claudication (Rutherford 1-3) presenting with new complaints (at least 6 months after previous revascularization) at the Vascular Center of university hospitals Leuven will be included if according to current guidelines their initial treatment should be conservative Inclusion Criteria: age > 17 yrs ABI ≤0.9 and/or 20% decrease after a maximal treadmill test intermittent claudication (Rutherford 1-3) ability to undertake an exercise test and read and understand Dutch questionnaires Exclusion criteria exercise test induced signs of complex arrhythmias or significant ischemia during baseline testing other comorbidity limiting participation in the exercise group

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walking Group<br> | Other: Walking<br>* Technology-guided semi-supervised walking therapy<br>|
| Active Comparator: Control<br> | Other: Control<br>* Go Home and Walk advice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain free walking distance | Treadmill protocol | Baseline - 12 weeks |
A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability of MT-1303 in healthy subjects.

Conditions
-----------------
Relapsing-remitting Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: MT-1303-Low
* Drug: MT-1303-High
* Drug: Fingolimod
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy and free from clinically significant illness or disease. Male and female subjects of non-childbearing potential aged 18 to 55 years. Normal or non-clinically significant 12-lead ECG. Holter recording with no clinically significant abnormalities. Systolic blood pressure: 90 to 140 mmHg, diastolic blood pressure: 50 to 90 mmHg Exclusion Criteria: A History of severe adverse reaction or allergy to any medical product. Clinically significant endocrine, thyroid, hepatic, respiratory, gastrointestinal, renal, cardiovascular disease, eye disorder or history of psychiatric/psychotic disorder. A history of tuberculosis. Have a positive HBsAg, HBcAb, HCVAb or HIV-1 and HIV-2 test. Previously having received MT-1303, fingolimod, or any other sphingosine-1-phosphate receptor modulators. Clinical relevant abnormal medical history, or physical findings or laboratory values. Clinically significant 12-lead ECG abnormalities. Clinical relevant abnormal findings in echocardiograph.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Experimental: MT-1303-Low<br>MT-1303-Low dose | Drug: MT-1303-Low<br> <br> |
| Experimental: MT-1303-High<br>MT-1303-High dose | Drug: MT-1303-High<br> <br> |
| Active Comparator: Fingolimod<br>Fingolimod | Drug: Fingolimod<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean hourly heart rate |  | up to day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of MT-1303 and its metabolite |  | up to day 28 |
Free Neurovascularized Muscle Transfer in Facial Reanimation of Long-standing Facial Palsy Patients

Study Overview
=================
Brief Summary
-----------------
The use of free Neurovascularized muscles like free latissimus and gracillis muscles for reanimation of long-standing facial palsy patients using the hypoglossal nerve for innervating these muscles

Detailed Description
-----------------
The investigators need to know which of the two muscles is better functionally and aesthetically in facial reanimation of patients with facial paralysis of more than one year duration.

Official Title
-----------------
Segmental Free Latissimus Versus Free Gracillis Muscles Powered by Hypoglossal Nerve in Facial Reanimation of Long-standing Facial Palsy Patients

Conditions
-----------------
Facial Paralysis

Intervention / Treatment
-----------------
* Procedure: Facial reanimation surgery by free muscle trasfer.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with facial paralysis more than one year what ever the cause. Exclusion Criteria: patients with uncontrolled diabetes.
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Segmental free latissimus muscle trasfer to the face. | Procedure: Facial reanimation surgery by free muscle trasfer.<br>* Muscle flap harvesting from the back or from the thigh to be insetted to the paralyzed side of the face with microvascular anastomosis of the muscle pedicle to facial artery and vein.<br>|
| Active Comparator: Group B<br>Free gracillis muscle trasfer to the face. | Procedure: Facial reanimation surgery by free muscle trasfer.<br>* Muscle flap harvesting from the back or from the thigh to be insetted to the paralyzed side of the face with microvascular anastomosis of the muscle pedicle to facial artery and vein.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in smile excursion with the two muscles in the paralyzed side from the pre operative state. | We will use SMILE system of Bray et al for assessment. | One year post operatively. |