linjc16/ctgov huggingface dataset:
Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled hypertension.

Official Title
-----------------
Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

Conditions
-----------------
Uncontrolled Hypertension

Intervention / Treatment
-----------------
* Device: Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individual is ≥ 18 and ≤ 80 years old. Individual has an office systolic blood pressure of 160 mmHG or greater (≥ 150 mmHg for Type 2 diabetics) based on an average of 3 office/clinic blood pressure readings Individual is adhering to a stable medication regimen including ≥ 3 anti-hypertensive medications(preferred that one is a diuretic) for a minimum of two weeks prior to screening. Exclusion Criteria: Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2 Individual has type 1 diabetes mellitus Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea. Individual has primary pulmonary hypertension. Individual is pregnant, nursing or planning to be pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation<br> | Device: Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system<br>* The Medtronic Multi-electrode Radiofrequency Renal Denervation System is comprised of a single-use, disposable catheter and a reusable generator.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute safety as measured by procedural complications |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Office Systolic Blood Pressure |  | Baseline to 6 months |
Microvascular Response in Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Vascular and neurological mechanisms are both likely to be involved in foot ulcer. We recently reported on the hand an original transient pressure-induced vasodilation (PIV) during a 5 mmHg/min increase of pressure strain using laser Doppler flowmetry. This physiological response to non noxious external local pressure strain is a widely protective cutaneous mechanism. The impairment of PIV in diabetic subjects may be relevant to the high prevalence of foot ulcer that occurs in these individuals. The aim of the project is to analyse the different physiopathological processes involved in PIV impairment in diabetic subjects as compared to matched controls.

Detailed Description
-----------------
The whole study is a prospective observational study of diabetic type 1 and type 2 subjects focusing on the various physical, physiopathological or pharmacological mechanisms that may interfere with the normal response of the cutaneous microcirculation.The study is currently conducted under various parallel groups of patients and control subjects matched on age and sexe. Techniques used for the study are only non-invasive investigations such as iontophoresis with laser doppler flowmetry, clinical and paraclinical non-invasive investigation of peripheral neuropathy, ultrasound imaging of peripheral arteries.

Official Title
-----------------
Microcirculation cutanée et Vasodilatation Induite Par la Pression Non-Nociceptive Chez Les diabètiques

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: local heating
* Device: iontophoresis
* Drug: actylcholine
* Drug: sodium nitroprusside


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes Exclusion Criteria: Non diabetic neuropathy Peripheral arterial 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: local heating|nan|
|Device: iontophoresis|nan|
|Drug: actylcholine|nan|
|Drug: sodium nitroprusside|nan|

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
-----------------
microcirculation, Laser doppler flowmetry, neuropathy, endothelial function
Effects of Medium Chain Triglyceride Oil, Versus Olive Oil, for Weight Loss

Study Overview
=================
Brief Summary
-----------------
The primary aim of this research project is to determine whether the incorporation of food products containing medium chain triglyceride (MCT) oil in a weight-loss program results in a different degree of weight-loss and total and regional fat mass loss than the incorporation of extra light olive oil. The secondary goals are to test whether there are differences in in metabolic risk profile changes between the 2 diets. We hypothesize that men and women who consumed MCT oil as part of their weight loss program will lose more weight and body fat than those who consume olive oil in their weight loss diet.

Official Title
-----------------
The Effects of a Weight Loss Diet Containing Medium Chain Triglyceride Oil, Versus Olive Oil, on Body Composition in Free-Living Adults

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Dietary Supplement: Weight loss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body mass index 27-33 kg/m2 pre-menopausal women weight stable for at least 6 months normal score on Brief Symptoms Inventory questionnaire Exclusion Criteria: chronic disease weight loss treatment medication known to affect body weight unstable blood pressure, glucose, lipid levels

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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: 1<br>MCT oil consumption | Dietary Supplement: Weight loss<br>* Weight loss study including consumption of either 22-25 g of medium chain triglyceride oil or olive oil<br>* Other names: MCT oil, Neobee 1053, Stepan Company;|
| Placebo Comparator: 2<br>Olive oil consumption | Dietary Supplement: Weight loss<br>* Weight loss study including consumption of either 22-25 g of medium chain triglyceride oil or olive oil<br>* Other names: MCT oil, Neobee 1053, Stepan Company;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight and fat mass, change in plasma lipid concentrations, fasting glucose and fasting insulin |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure, change in fat-free mass |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overweight, Obesity, Weight loss, Medium chain triglycerides, Cardiovascular disease risk
Safety and Local Tolerability of Prevenar in Indian Children

Study Overview
=================
Brief Summary
-----------------
This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian children. Prevenar is indicated for active immunization of infants and children from 6 weeks of age through 9 years of age against invasive disease (including meningitis, bacteraemic pneumonia, bacteraemia, sepsis) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F. Prevenar has been marketed in India since June 2006. The Board of Health in India has given restricted permission to import and market Prevenar. The present study is a post-approval regulatory commitment to the Board of Health in India. This is an observational study and the protocol for the study has been approved by the Board of Health.

Official Title
-----------------
A Postmarketing Surveillance Study Evaluating the Safety and Local Tolerance of PREVENAR in Indian Children

Conditions
-----------------
Pneumococcal Infections

Intervention / Treatment
-----------------
* Biological: pneumococcal conjugate vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA Subjects must meet at least one of the following conditions to be eligible for inclusion in the study: For Primary Immunization Schedule: Healthy male or female subjects 6 weeks + 5 days of age with no previous PREVENAR vaccination For Catch-up Immunization Schedule: Healthy male or female subjects 12-23 months of age EXCLUSION CRITERIA Subjects with any of the following conditions or characteristics will be excluded from the study. A known or suspected history of Streptococcus pneumoniae disease. A previous anaphylactic or other severe vaccine-associated adverse event. A known or suspected impairment of immune system (including HIV infection), or recipient of immunosuppressive agents. A major congenital, developmental or serious chronic disorder. A confirmed or suspected underlying evolving neurological disorder or history of seizures. A history of thrombocytopenia or any coagulation disorder. Any acute illness at the time of vaccine administration

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 24 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: pneumococcal conjugate vaccine|nan|

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
-----------------
Pneumococcal Infections/PC (Prevention & Control)
Serum Thromboxane B2 Assay as a Measure of Platelet Production in Healthy Volunteers Taking Aspirin

Study Overview
=================
Brief Summary
-----------------
Some aspirin-treated patients have a blunted pharmacological response predisposing to clinical failure. The investigators hypothesize that the blunted response often results from increased rate of platelet production and some failures will be prevented by administering aspirin twice daily. The overall objective is to develop a valid method to quantify platelet production (without the use of radioactive isotopes) in order to examine the hypothesis that enhanced platelet production is a common cause of poor aspirin responsiveness in patients with atherothrombosis.

Detailed Description
-----------------
The specific objective of this study is to validate the Cayman Chemical serum thromboxane immunoassay as a measure of platelet production in healthy subjects who are treated with aspirin by demonstrating that the recovery of their serum thromboxane B2 levels occurs at a rate of about 10% per day after aspirin cessation.

Official Title
-----------------
Serum Thromboxane B2 Assay as a Measure of Platelet Production in Healthy Volunteers Taking Aspirin

Conditions
-----------------
Aspirin

Intervention / Treatment
-----------------
* Drug: Aspirin 81 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-smoking volunteers; Age ≥ 18 years; Exclusion Criteria: Allergy or intolerance to aspirin; Current pregnancy; Use of aspirin or drugs interfering with platelet function (NSAIDs, anticoagulants) within one week of study enrolment.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Aspirin 81 mg<br>Healthy volunteers will receive 5 days of aspirin. Following cessation of aspirin, daily blood samples will be collected for serum thromboxane B2 measurement | Drug: Aspirin 81 mg<br>* Healthy volunteers will receive 5 days of aspirin 81 mg daily. Following cessation of aspirin, daily blood samples will be collected for serum thromboxane B2 measurement<br>* Other names: Aspirin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum thromboxane B2 | The daily rate of platelet production can be estimated by calculating the daily recovery rate of serum thromboxane B2 after aspirin over 5 days following aspirin cessation for each participant | daily for 5 days after aspirin cessation |
Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye

Study Overview
=================
Brief Summary
-----------------
InflammaDry is a rapid diagnostic test for the detection of elevated levels of Matrix Metalloproteinase-9 (MMP-9) protein in tear fluid.

Detailed Description
-----------------
The InflammaDry test will be used to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation.

Conditions
-----------------
Dysfunctional Tear Syndrome

Intervention / Treatment
-----------------
* Device: InflammaDry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Patient voluntarily reported at least 1 episode of any of the following ocular symptoms during the last month: Burning or stinging Sandy or gritty feeling Foreign body sensation Tearing Light sensitivity Intermittent or fluctuating vision Tired eyes Exclusion Criteria Allergy to cornstarch or Dacron Allergy to topical anesthetic or fluorescein dye Prior eye injury, trauma, or ocular surgery within the last 3 months Known blockage of the lacrimal drainage system Contact lens wear in the last month Previous corneal refractive surgery including RK, LASIK or PRK surgery Have an active ocular infection or history of a recent ocular infection in the last month Have active intraocular inflammation or history of intraocular inflammation, e.g. Uveitis Use of oral doxycycline, corticosteroids, or immunomodulators in the last month Have received topical ocular corticosteroids, topical Nonsteroidal (NSAIDs) therapy, or topical ocular cyclosporine in the last month Pregnant or lactating Use of any topical ophthalmic medications, including artificial tears 2 hours prior to enrollment

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 |
| --- | --- |
| InflammaDry<br>Patients suspected of having dry eye will be tested with the InflammaDry. | Device: InflammaDry<br>* A noninvasive immunoassay for detecting MMP-9 levels in tears.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes | Negative agreement is the percentage of true negative cases compared to clinical assessment (specificity). Positive agreement is the percentage of true positive cases compared to clinical assessment (sensitivity). The InflammaDry test was compared with the clinical assessment of tear break-up time, Schirmer tear testing, and corneal staining for the confirmation of dry eye, both with and without the inclusion of the Ocular Surface Disease Index (OSDI), as a confirmatory test. | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye
The Mechanism of Dexmedetomidine in Improving Delirium After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators aim to evaluate the roles of α7nAchR in the mechanisms of dexmedetomidine in improving delirium after cardiac surgery. The results of this study would lay the foundation for revealing the mechanisms of dexmedetomidine improving delirium after cardiac surgery and provide a new idea to the early treatment of delirium.

Official Title
-----------------
The Mechanism of Dexmedetomidine in Improving Delirium After Cardiac Surgery

Conditions
-----------------
Dexmedetomidine, Delirium, Cardiac Surgery

Intervention / Treatment
-----------------
* Drug: dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU patients underwent cardiac surgery age ≥ 60 years Exclusion Criteria: Preoperative cognitive decline, mental illness, preoperative long-term use of hormone patients, preoperative alcohol dependence, patients with alcohol withdrawal symptoms

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 100 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: DEX group<br>use DEX | Drug: dexmedetomidine<br>* dexmedetomidine<br>|
| No Intervention: control group<br>use placebo | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delirium incidence |  | 1 month | 
| α7nAChR level |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mechanical ventilation time |  | 7 days | 
| ICU stay time |  | 1 month |
Inspiratory Muscle Training in Hypercapnic COPD

Study Overview
=================
Brief Summary
-----------------
The trial intends to investigate, whether inspiratory muscle training in hypercapnic patients improves inspiratory muscle strength, inspiratory muscle endurance and endurance to walk within six minutes.

Detailed Description
-----------------
Inspiratory muscle training is known to improve inspiratory muscle strength, inspiratory muscle endurance and walking distance within six minutes in patients with neuromuscular and thoraco-restrictive disease as well as in patients with COPD. Studies have only been conducted in patients without established respiratory failure. COPD patients with respiratory failure though are characterized by higher work rates of the inspiratory muscles and higher esophageal pressure swings compared to non-hypercapnic patients indication a discrepancy between muscle load and muscle capabilities. Therefore we hypothesize that for these patients training of their inspiratory muscles will be of benefit in terms of improvement of muscular and whole body endurance. During this investigation inspiratory muscle training will be applied in a randomized controlled fashion in 40 patients over a period of four weeks parallel to physical rehabilitation.

Official Title
-----------------
Randomized Controlled Trial of Inspiratory Muscle Training in Patients With Stable Hypercapnic Respiratory Failure Due to COPD

Conditions
-----------------
COPD, Respiratory Failure

Intervention / Treatment
-----------------
* Device: inspiratory muscle training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD with FEV1/FVC < 70 % age > 18 stable disease able to walk carbon dioxide >= 48 mmHg Exclusion Criteria: ejection fraction of the heart < 40 % active psychiatric disease bronchial hyperresponsiveness according to ATS criteria pregnancy renal insufficiency with a creatinine < 2 mg/dl

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: inspiratory muscle training|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inspiratory muscle strength |  |  | 
| inspiratory muscle endurance |  |  | 
| walking distance with dyspnea score |  |  | 
| Carbon dioxide level |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, respiratory failure, inspiratory muscle training