linjc16/ctgov huggingface dataset:
An Open-Label Study of Vascazen in Cardiac Rehab Patients With Deficient Blood Omega-3 Fatty Acid Levels

Study Overview
=================
Brief Summary
-----------------
The investigators aim to test the hypothesis that dietary supplementation with VASCAZEN will correct omega-3 deficiency in cardiac rehab patients and improve biochemical risk factors.

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Other: VASCAZEN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects (> or = 18 years of age) Enrolled in Cardiac Rehabilitation clinic with documented cardiovascular disease as assessed by the principle investigator Has had cardiovascular examination within the past 2 months Exclusion Criteria: Subjects who refuse to provide written consent Subjects with medical conditions, as determined by the principal investigator, which prevented them from study participation Subjects with a known bleeding or clotting disorder Subjects with known allergies to fish Subjects with an implantable cardiac defibrillator Subjects with a heart transplant Female subjects who are currently taking hormone replacement therapy Subjects who are pregnant or planning on becoming pregnant Subjects currently taking Omega-3 fatty acid supplements (either under medical supervision or self-administered)

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vascazen<br>Enrolled patients will receive four capsules daily of VASCAZEN (a 3.0 gram daily dose of EPA+DHA) for a total of 12 weeks. | Other: VASCAZEN<br>* All enrolled subjects will receive 4 capsules daily of VASCAZEN which delivers 3.0 grams of EPA and DHA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sum of Omega-Score and Omega-Index | Change in the sum of the subject's blood Eicosapentaenoic acid (EPA) + Docosahexaenoic acid (DHA) + Docosapentaenoic acid (DPA) levels (Omega-Score) and the change in the sum of the subject's red blood cell (RBC) EPA + DHA levels (Omega-Index) over 12 weeks of study treatment with Vascazen | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient health questionnaire-9 (PHQ-9) depression scale | Change in patient health questionnaire-9 (PHQ-9) depression scale after 12 weeks of study treatment | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fatty Acids, Omega-3, Omega-3 fatty acids, Docosahexaenoic acid (DHA), Eicosapentaenoic acid (EPA), Docosapentaenoic acid (DPA), Omega Index, Omega Score, Cardiac Rehab
SPECT/CT in the Diagnosis of Dementia

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to evaluate whether Tc-99m-ECD-SPECT/CT enhances early diagnosis of dementia in two specific patient groups: (1) patient with mild cognitive impairment, and (2) patient with possible symptoms and signs of frontotemporal dementia. Evaluation of SPECT/CT data is performed both by visual and quantitative voxel-based analyses (Statistical Parametric Mapping). The final diagnosis is based on up to four years clinical follow-up.

Official Title
-----------------
SPECT/CT in the Diagnosis of Dementia

Conditions
-----------------
Dementia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (one of these): healthy control mild cognitive impairment (recruited from a population based data) clinically suspected frontotemporal dementia (unset diagnosis) Exclusion Criteria: unable to be scanned with SPECT/CT
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 |
| --- | --- | --- |
| Final diagnosis | (1) controls, (2) stable mild cognitive impairment (MCI), (3)MCI converted to Alzheimers's disease (AD), (4) frontotemporal dementia (FTD), suspected FTD converted to AD, (5) other final diagnoses | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnosis, Dementia, Imaging
The Role of Fibrocytes in Acute Lung Injury

Study Overview
=================
Brief Summary
-----------------
The important character of acute lung injury (ALI) is alveolar capillary membrane damage caused by different diseases, such as sepsis, trauma and shock. One of the important pathological stages is the varying degrees of interstitial fibrosis and semi-permeable alveolar membrane fibrosis. It has been proved that CXCL12/SDF-1 (stromal cell-derived factor-1) induces fibrocyte migration, and promotes fibrosis progression. Study indicated that inhibition of TLR4 receptor signaling pathway improves fibrosis progression induced by ALI, however, the role of fibrocyte in ALI is still unclear. The fibrocytes was significantly increased in asthmatic patients with pulmonary fibrosis, which companies with increased CTGF expression. Therefore, this project assumes that fibrocyte will differentiation to fibroblast/myofibroblast in patient with acute lung injury, which in turn leads to progression of fibrosis. The central hypothesis of this project is that peripheral progenitor cell fibrocytes play an important role in alveolitis caused by acute lung injury. The overall objective of this project is to study the role of fibrocytes in acute lung injury.

Official Title
-----------------
The Role of Fibrocytes in Acute Lung Injury

Conditions
-----------------
Acute Lung Injury(ALI)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Lung Injury patients Above 20 years old Bilateral lung infiltrates PaO2/FiO2<300mmHg PCWP<18mmHg Exclusion Criteria: Pregnant women Under 20 years old Hb<8.0mg/dl

Ages Eligible for Study
-----------------
Minimum Age: 20 Years


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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Lung Injury(ALI)
Evaluation of Postoperative Pain After Tension-free Obturator Tape Operation (TVT-O) With or Without Local Anesthetic

Study Overview
=================
Brief Summary
-----------------
BACKGROUND: Compare the pain intensity after TVT-O procedure in the inner part of the thigh where the anesthetic substance will be injected versus the inner part of of the thigh without anesthetic injection in the same woman. The advantage of this work is that this method of testing neutralizes the effect of pain thresholds of different women. If an advantage will be found in injecting anesthetic as a reduction in postoperative pain, it could be recommended for all women who undergo surgery of this kind. METHODS: Preoperative women will be offered the opportunity to participate in the study after a detailed explanation of the study and determine a date for an elective TVT-O procedure. After signing the Informed Consent Form, they will undergo a TVT-O procedure with injection of anesthetic into one of the obturators membranes. In a random order, Marcaine 5-ml will be injected into a left or right obturator membrane. One side with Marcaine (Bupivacaine HCL) 0.5% 5 mg / mL Injection,opposite side without injection of any anesthetic. Before and after surgery, patients will receive Visual Analogue Scale (VAS) instruction and will be polled at the following time points: 1,6,12,24 hours after surgery per inner part of the thigh separately. Each patient will rate the intensity of the pain she feels on the pain questionnaire at each of the time points mentioned before.

Official Title
-----------------
Evaluation of Postoperative Pain After Tension-free Obturator Tape Operation (TVT-O) With or Without Local Anesthetic

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Drug: Marcaine 0.5 % Injectable Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Women undergoing TVT-O Exclusion Criteria: • Repeat surgery

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 Years

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

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: Anesthetic<br> | Drug: Marcaine 0.5 % Injectable Solution<br>* Intra -operative injection into obturator membrane<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg pain | VAS score | 1 hour after surgery | 
| Leg pain | VAS score | 6 hours after surgery | 
| Leg pain | VAS score | 12 hours after surgery | 
| Leg pain | VAS score | 24 hours after surgery |
GORE-TEX PROPATEN Vascular Graft Study

Study Overview
=================
Brief Summary
-----------------
To demonstrate equivalence in patency performance of GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts in a peripheral bypass application to support a claim of substantial equivalence.

Official Title
-----------------
Comparison of Primary Patency Between GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts

Conditions
-----------------
Peripheral Vascular Diseases

Intervention / Treatment
-----------------
* Device: Vascular graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient requires primary above-knee bypass where the proximal anastomosis will be to the common femoral or proximal superficial femoral artery and the distal anastomosis will be the popliteal artery proximal to the medial head of the gastrocnemius; Patient has Grade III or IV occlusive vascular disease; Patient has a postoperative life expectancy greater than one year; Patient is at least 21 years of age; Patient is able to comply with all study requirements and be available for follow-up visits at 1 month, 6 months and 12 months post procedure; Patient is willing and able to provide written, informed consent. Exclusion Criteria: Patient had a previous bypass in the diseased extremity (below iliacs); Patient has known coagulation disorders including hypercoagulability; Patient has had any previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin; Patient has an acute embolic arterial occlusion; Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts; Patient had percutaneous transluminal angioplasty to the implant site within the previous 30 days; Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure; Patient has active infection in the region of graft placement; or Patient has an incomplete preoperative assessment (as outlined in this protocol) due to an emergency procedure, a traumatic injury or any other reason.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Vascular graft|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency at 12 months |  |  | 
| Major device complication rates at 12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical failures |  |  | 
| Secondary patency |  |  |
The Effect of Administration on N-Acetylcysteine on Serum Creatinine Levels in Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Primary outcome: Serum creatinine change at 4 hours and 48 hours following 4 doses of N-acetylcysteine (total 4800 mg) compared to baseline serum creatinine. Secondary outcome: Serum Cystatin C change at 4 hours and 48 hours post 4 doses of N-acetylcysteine compared to baseline serum Cystatin C.

Detailed Description
-----------------
N-acetylcysteine has been reported to lower serum creatinine in normal individuals. The mechanism of this effect is unknown but possible stimulation of tubular secretion of creatinine has been hypothesized based upon a lack of effect on Cystatin C levels. If this effect also occurs in subjects with chronic kidney disease, interpretation of clinical trials using N-acetylcysteine for prophylaxis of acute kidney injury would be confounded. To answer whether such confounding occurs, 50 patients with stable chronic kidney disease (Stage 3-5) will be given 4 doses of N-acetylcysteine, 1200 mg each, with measurement of serum creatinine and Cystatin C before, 4 hours and 48 hours after the last dose. No other interventions, including changes in medications, will be permitted during the study.

Official Title
-----------------
The Effect of Administration on N-Acetylcysteine on Serum Creatinine Levels in Patients With Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: N-acetylcysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Estimated GFR 10-59 ml/min/1.73m2 by 4 variable MDRD equation Less than a 10% difference between the baseline creatinine and the recruitment creatinine obtained within 3 months of the trial Exclusion Criteria: Unable to give informed consent Unwillingness to return for follow-up blood sampling Unstable renal function Subjects taking H2-blockers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: N-acetylcysteine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine change at 4 hours and 48 hours following 4 doses of N-acetylcysteine (total 4800 mg) compared to baseline serum creatinine |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Cystatin C change at 4 hours and 48 hours post 4 doses of N-acetylcysteine compared to baseline serum Cystatin C |  | 48 hours |
Influence of Erythropoietin on Bone Marrow Microenvironment

Study Overview
=================
Brief Summary
-----------------
This will be a prospective observational study. The investigators will compare Erythropoietin (Epo) levels, erythropoiesis, and regulators of erythropoiesis, bone imaging and bone metabolism in healthy volunteers living at different altitudes.

Official Title
-----------------
Influence of Erythropoietin on Bone Marrow Microenvironment: A Pilot Study

Conditions
-----------------
Healthy Men and Non- Pregnant Women

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men and non-pregnant women, ages ≥18-40 years and ≥ 60 years living in the predefined area Exclusion Criteria: Known bone pathology including osteoporosis, known haematological disease, known renal disease, heart insufficiency, pulmonal disease pregnancy

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of EPO level between control groups |  | up to 4 years |
The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.

Study Overview
=================
Brief Summary
-----------------
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

Detailed Description
-----------------
A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

Official Title
-----------------
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

Conditions
-----------------
T2DM (Type 2 Diabetes Mellitus)

Intervention / Treatment
-----------------
* Drug: Dapagliflozin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with T2DM aged 19 to 80 years Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5% Subjects with BMI of 20-45 kg/m2 Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study Exclusion Criteria: Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors) Diabetic ketoacidosis, diabetic coma or precoma within the past year Urinary tract infections or genital infections within Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg) eGFR < 60 mL/min/1.73 m2 Severe heart failure (NYHA class III/IV)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 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: Study group<br>DWP16001 A mg, Dapagliflozin placebo | Drug: Dapagliflozin<br>* Dapagliflozin Tablet<br>* Other names: DWP16001;|
| Active Comparator: Control group<br>DWP16001 A mg placebo, Dapagliflozin | Drug: Dapagliflozin<br>* Dapagliflozin Tablet<br>* Other names: DWP16001;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c |  | at 24 weeks |
Efficacy of Administration of ACE-Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Patients with diabetes mellitus and definite autonomic and peripheral neuropathy were randomized to receive quinapril or no treatment for 2 years.

Official Title
-----------------
Efficacy of Administration of Angiotensin Converting Enzyme Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus

Conditions
-----------------
Diabetic Autonomic Neuropathy

Intervention / Treatment
-----------------
* Drug: Quinapril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus with both autonomic and peripheral neuropathy Exclusion Criteria: Hypertension, coronary heart disease
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quinapril|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in R-R variation during deep breathing |  | 2 years | 
| Changes in response to Valsalva maneuver |  | 2 years | 
| Changes in 30:15 ratio |  | 2 years | 
| Changes in blood pressure response to standing |  | 2 years |
A Pharmacokinetics Study of MultiHance in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults

Official Title
-----------------
A Clinical Investigation of the Pharmacokinetics and Safety of MultiHance in Patients From 2-5 Years of Age Undergoing A Clinical Indicated MRI of the CNS

Conditions
-----------------
Central Nervous System Pathology

Intervention / Treatment
-----------------
* Drug: Multihance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female between 2 and 5 years of age Obtained informed consent from patient's parent or guardian Obtain assent when applicable according to local law Known or suspected disease of the central nervous system (brain or spine) Referred for MRI of the brain or spine requiring an injection of an MR contrast agent Exclusion Criteria: Contraindications to MR examination Undergoing MRI in an emergency situation Known allergy to one or more ingredients in the contrast agent or history of hypersensitivity to gadolinium or metals Sickle cell anemia Likely to undergo an invasive examination within 72 hours after administration of the investigational product

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Multihance|0.5M administered as a single injection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the blood PK of Multihance in patients from 2 to 5 years of age |  | up to 24 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of Multihance in patients from 2 to 5 years of age |  | through 72 hours post dose |