linjc16/ctgov huggingface dataset:
Low-dose Combination of Three Antihypertensive Drugs

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the efficacy and safety of low-dose combination of three antihypertensive drugs versus fixed high-dose combination of two antihypertensive drugs in arterial hypertension

Detailed Description
-----------------
The aim of the study is to compare the efficacy and safety of commercially available low-dose combination of three antihypertensive drugs versus commercially available fixed high-dose combination of two antihypertensive drugs in arterial hypertension

Official Title
-----------------
Randomized Comparison of Fixed Low-dose Combination of THREE Antihypertensive Drugs Versus Fixed High-dose Combination of Two Antihypertensive Drugs in Arterial Hypertension (the 3D Trial)

Conditions
-----------------
Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: Tripliam (perindopril, indapamide, amlodipine)
* Drug: Reaptan (perindopril, amlodipine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with arterial hypertension resistant to monotherapy Exclusion Criteria: None
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: Three antihypertensive Drugs<br>Patients will be treated with Tripliam, that is a commercially available fixed low-dose combination of three antihypertensive drugs, that is 5 mg/daily perindopril, 1,25 mg/daily indapamide and 5 mg/day amlodipine | Drug: Tripliam (perindopril, indapamide, amlodipine)<br>* Fixed combination of perindopril 5 mg, indapamide 1,25 and amlodipine 5 mg<br>* Other names: Combination of three antihypertensive drugs;|
| Active Comparator: Two antihypertensive drugs<br>Patients will be treated with Reaptan, that is a commercially available fixed high-dose combination of two antihypertensive drugs, that is 10 mg/daily perindopril and 5 mg/day amlodipine | Drug: Reaptan (perindopril, amlodipine)<br>* Fixed combination of perindopril 10 mg and amlodipine 5 mg<br>* Other names: Combination of two antihypertensive drugs;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who reach target blood pressure | How many patients have blood pressure within normal limits | From baseline to the end of the 3-month study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arterial hypertension, antihypertensive drugs
Adaptation and Validation of a Nutrition Literacy Assessment Instrument

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a tool to help researchers better understand what diet information people know and what skills they use to make diet choices.

Official Title
-----------------
Adaptation and Validation of a Nutrition Literacy Assessment Instrument

Conditions
-----------------
Dietary Habits

Intervention / Treatment
-----------------
* Other: Nutrition Literacy Assessment Instrument (NLAI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to speak and read English Have 1 or more of the following diseases: diabetes, hyperlipidemia, hypertension, and/or overweight/obesity Exclusion Criteria: Visual acuity insufficient to read the testing instrument Cognitive impairment Weight > 500 pounds

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 |
| --- | --- |
| Nutrition Literacy<br>Participants will be asked to completed the Nutrition Literacy Assessment Instrument (NLAI). | Other: Nutrition Literacy Assessment Instrument (NLAI)<br>* Assessment tool which combines elements of different nutrition literacy tools.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nutrition Literacy Assessment Instrument (NLAI) responses | Participants will complete the NLAI two times over the course of one month. Responses will help shape adaptions to the tool for use in a primary care population. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutrition literacy
Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to improve the definition of the two main types of secondary tricuspid regurgitation.

Official Title
-----------------
Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation

Conditions
-----------------
Remodeling, Cardiac, Tricuspid Regurgitation

Intervention / Treatment
-----------------
* Other: Moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography in patients stabilized.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patients ≥ 18 years old, with moderate to severe tricuspid regurgitation (≥ 2/4), agreeing to participate ; The patients included can be ambulatory patients or stabilized hospitalised patients (meaning patient clinicaly stable, not decompensated, and whose normovolemia has been checked). Non opposition of the patient Exclusion Criteria: Patient whose accoustic window is judged by the operator as incompatible with a precise evaluation of the tricuspid regurgitation or anatomy of the right cavity ; TR < grade 2 ; TR secondary to primary pulmonary hypertension or congenital cardiopathy ; Primary tricuspid regurgitation (due to rheumatic heart disease, medication - included benfluorex, due to endocarditis, valvular prolapse, carcinoid syndrom or a cardiac stimulation lead …) ; Significant left heart valvulopathy (Mitral regurgitation > grade 2, Aortic insufficiency > grade 2, Mitral stenosis < 2 cm², Aortic stenosis < 1.5 cm²). A valvulopathy sucessfully operated isn't considered as an exclusion criteria; Cardiopathy with significative systolic dysfunction (FE< 40%) ; Patients whose life expectantcy is less than 1 year due to a pathology independent of the TR (neoplasic process for example) ; Patient under judicial protection.

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

| Intervention/Treatment |
| --- |
|Other: Moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography in patients stabilized.|Moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography in patients stabilized.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite criteria : cardiovascular death or unscheduled hospitalizations due to cardiovascular event. |  | through study completion, an average of 1 year |
Open-Label Expanded Access Treatment With Pegunigalsidase Alfa for Fabry Disease Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this treatment protocol is to provide guidance to Treating Physicians who seek access to pegunigalsidase alfa for Fabry patients whose clinical condition, in the opinion of the Treating Physician, requires treatment with enzyme replacement therapy (ERT) with pegunigalsidase alfa and a) cannot be adequately treated with currently approved FDA products and/or b) are not able or willing to participate in any of the on-going clinical trials in the United States.

Official Title
-----------------
Expanded Access Treatment With Open-Label Pegunigalsidase Alfa for Fabry Patients

Conditions
-----------------
Fabry Disease

Intervention / Treatment
-----------------
* Drug: Pegunigalsidase Alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In the opinion of the Treating Physician, the patient cannot be adequately treated with any FDA approved drugs for Fabry and is not able to enroll in any current clinical trial for Fabry disease. Patient (or legal guardian) is able to sign an informed consent prior to treatment. A documented diagnosis of Fabry disease. Preferably two, but at minimum 1, historical serum creatinine evaluations in the last 2 years with the latest value within the last 6 months. Female patients and male patients whose co-partners are of child-bearing potential agree to use a medically acceptable method of contraception, not including the rhythm method. Acceptable methods of contraception include hormonal products, intrauterine device, or male or female condoms. Contraception should be used for 90 days after treatment discontinuation. Exclusion Criteria: Patients enrolled and currently treated in Study PB-102-F20, and patients enrolled and currently treated in Extension Study PB-102-F60 Patients who currently are on treatment under any other ongoing clinical trials of PRX-102 History of Type 1 (anaphylaxis or anaphylactoid like) life-threatening hypersensitivity during previous exposure to other ERTs which could not be handled with medication Women who are breastfeeding may not participate unless they agree to stop breastfeeding. Women who are currently pregnant.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pegunigalsidase Alfa|Pegunigalsidase alfa is a recombinant ERT (enzyme replacement therapy) used to treat Fabry disease (dosage: 1 mg/kg body weight every 2 weeks).|

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
-----------------
Fabry Disease, Pegunigalsidase alfa
The Effect of Spinal Anesthesia on Heart Rate Variability in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
Cardiac autonomic neuropathy is a common complication of diabetes and is associated with resting tachycardia. Regional anesthesia could interrupt normal autonomic activity by central sympathetic blockade. The investigators evaluate the relation of severity of diabetes and heart rate variability, also the impact of spinal anesthesia on the change of heart rate variability.

Conditions
-----------------
Diabetes, Heart Rate Variability, Spinal Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing lower limb surgery with spinal anesthesia (ASA class 1,2,3) Exclusion Criteria: severe coagulopathy, short height, arrhythmia patients, patients taken medication which could affect autonomic nervus system (bata- blocker or alpha-blocker)

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| control ( patients without diabetes)<br>patients without diabetes | |
| DM ( patients with diabetes)<br>patients with diabetes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Heart rate variability during spinal anesthesia : total power, power of LF and HF, and LF/HF ratio |  | 10 min before spinal anesthesia (T0: Baseline ) 10 min (T1), 20 min (T2) and 30 min (T3) after spinal injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Rate Variability, spinal anesthesia, DM, cardiac autonomic dysfunction
A Clinical Trial Assessing Safety of MF101 for Hot Flushes

Study Overview
=================
Brief Summary
-----------------
This Phase 1, open label, randomized clinical trial will enroll 40 generally healthy, postmenopausal women aged 40-65 years old. Women will be randomized to one of two oral doses of MF101 for 4 weeks. Participants will be recruited at 3 clinical sites in the United States.

Detailed Description
-----------------
MF101 is an oral, non-hormonal, botanical agent being investigated for the treatment of menopausal hot flashes.

Official Title
-----------------
A Phase 1 Open Label, Randomized Clinical Trial Assessing Safety of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women

Conditions
-----------------
Hot Flashes

Intervention / Treatment
-----------------
* Drug: MF101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (partial list): Postmenopausal women aged 40-65 years. Provide informed consent. Currently receive medical care from a health care provider. Other inclusions apply. Exclusion Criteria (partial list): History of malignancy other than non-melanoma skin cancer or cervical cancer that was diagnosed and fully treated less than 5 years before screening. Unexplained uterine bleeding within 6 months prior to Screening. History of deep vein thrombosis or pulmonary embolism. Active liver disease or a history of impaired. Active gallbladder disease. Other exclusions apply.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MF101 10 grams/day<br> | Drug: MF101<br>* MF101 10 g/day MF101 15 g/day<br>* Other names: Menerba;|
| Experimental: MF101 15 grams/day<br> | Drug: MF101<br>* MF101 10 g/day MF101 15 g/day<br>* Other names: Menerba;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of MF101, 10 g/day and 15 g/day | New or worsening abnormalities on breast, physical and general exams, laboratory measures, transvaginal ultrasound, abnormal uterine bleeding, adverse events and serious adverse events. | Randomization to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the safety of MF101 10g/day and 15 g/day | To compare the safety of the 2 doses of MF101 | Randomization to 4 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hot Flashes, Hot Flushes, Vasomotor Symptoms, Menopausal Symptoms
Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)

Study Overview
=================
Brief Summary
-----------------
The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.

Official Title
-----------------
MK-476 IV Formulation Phase III Open Label Exploratory Comparative Study - Acute Exacerbations of Asthma -

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: montelukast sodium
* Drug: montelukast sodium
* Drug: aminophylline hydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult participants with acute asthma attacks Exclusion Criteria: Participant has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.). Participant has a smoking habit (15 cigarettes per day) within a month prior to screening period, and/or has a smoking history (20 cigarettes per day) of more than 15 years. Participant has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease.

Ages Eligible for Study
-----------------
Minimum Age: 15 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montelukast 7 mg<br>Montelukast 7 mg IV administration | Drug: montelukast sodium<br>* Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes<br>* Other names: MK-0476;|
| Experimental: Montelukast 14 mg<br>Montelukast 14 mg IV administration | Drug: montelukast sodium<br>* Montelukast 14 mg single injection (IV bolus administration) over 5 minutes<br>* Other names: MK-0476;|
| Active Comparator: Aminophylline 250 mg<br>Aminophylline 250 mg IV drip administration | Drug: aminophylline hydrate<br>* Aminophylline 250 mg IV drip infusion over 60 minutes<br>* Other names: Kyophyllin® Injection 2.5%, FK05;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration | The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period. | Baseline and 60 minutes after study drug administration |
Evaluation of the Effects of Oxygen Therapy and Enalapril for Diabetic Macular Ischemia

Study Overview
=================
Brief Summary
-----------------
In this study, patients were divided into 3 group with 35 cases including: 1.oxygen 2.enalapril 3.control. In the beginning of the study, best corrected visual acuity (BCVA), uncorrected visual acuity (UCVA), and optical coherence tomography (OCT) were measured. Patients in the oxygen group were given oxygen 10 lit/min 1 hour twice a day at the first month, once a day at the second month and every other day at the third month. In the enalapril group, patients were given enalapril 5 mg every night and placebo was given for the patients in third group. At the end of first month the patients' vision was checked again and at the the end of the third month the first physical examinations were performed. In the first group, arterial blood gas (ABG) was taken before and after oxygen therapy as well.

Official Title
-----------------
Evaluation of the Effects of Oxygen Therapy and Enalapril for Diabetic Macular Ischemia

Conditions
-----------------
Diabetic Macular Ischemia

Intervention / Treatment
-----------------
* Drug: enalapril
* Other: oxygen
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with diabetic macular ischemia Exclusion Criteria: HTN > 1140/90 or HTN controlled by ACE inhibitors FBS > 200 Severe anemia, COPD, cataract, HRPDR and diffuse macular edema
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxygen<br> | Other: oxygen<br>* oxygen 10 lit/min 1 hour twice a day at the first month, once a day at the second month and every other day at the third month<br>|
| Experimental: Enalapril<br> | Drug: enalapril<br>* enalapril 5 mg every night<br>|
| Placebo Comparator: Control<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Continuous Versus Intermittent Sciatic Block for Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The role of a sciatic block in addition to a femoral block remains controversial. The study addresses this topic by comparing a continuous block versus an injection on demand.

Official Title
-----------------
Continuous Versus Intermittent Sciatic Block Combined With a Continuous Femoral Block for Patients Undergoing Total Knee Arthroplasty: a Prospective, Randomized Trial.

Conditions
-----------------
Total Knee Arthroplasty, Pain

Intervention / Treatment
-----------------
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for total knee arthroplasty Exclusion Criteria: failure to establish femoral and sciatic block insufficient analgesic effect of the block patient declines to participate

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: intermittent<br>injection of ropivacaine on demand | Drug: Ropivacaine<br> <br> |
| Other: continuous<br>continuous ropivacaine infusion | Drug: Ropivacaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score (VRS) |  | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of injections into the sciatic catheter |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain score