linjc16/ctgov huggingface dataset:
Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of two dosages (600mg/day and 1200mg/day) of bicifadine SR with placebo for 14 weeks in reduction of chronic neuropathic patin (measured by a daily rating of pain intensity) associated with diabetic periperal neuropathy in adult outpatients. To compare the tolerability of two dosages of bicifadine SR with placebo in adult outpaitens treated for chronic neuropathic pain for 14 weeks associated with diabetic peripheral neuropathy.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Parallel, Multicenter Study of the Safety and Efficacy of Two Dosages of Bicifadine SR in Adult Outpatients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Conditions
-----------------
Diabetic Peripheral Neuropathy

Intervention / Treatment
-----------------
* Drug: Bicifadine
* Drug: Bicifadine
* Drug: Bicifadine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 18 years or older Diagnosis of type-1 or type 2 non-insulin dependent diabetes mellitus Chronic bilateral pain due to diabetic neuropathy Pain for at least six months Primary pain is located in the feet Others-contact site for information Exclusion Criteria: Symptoms of other painful conditions Presence of amputations other than toes Clinically significant psychiatric or other neurological disorder Use of certain medications Clinically important other diseases Pregnancy History of alcohol or narcotic abuse within two years Others-contact site for information

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug<br>Bicifadine | Drug: Bicifadine<br>* 600mg/day<br>|
| Experimental: Drug: 2<br>Bicifadine | Drug: Bicifadine<br>* 1200 mg<br>|
| Placebo Comparator: Control<br>Placebo of Bicifadine | Drug: Bicifadine<br>* placebo tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and Safety |  | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Improvement, McGill Pain Questionnaire, Amount of Rescue Medication Used for Pain, Quality of Life Survey (SF-36), Patient Global Impression of Change |  | 14 weeks |
Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery

Study Overview
=================
Brief Summary
-----------------
Remote ischaemic preconditioning has shown its cardiac protective effect during heart surgery including coronary artery bypass graft surgery, congenital heart disease and aneurysm. However, no data was reported on heart valve disease surgery. Rheumatic heart disease is one of the major heart diseases requiring surgery in China. Thus, the investigators chose heart valve disease as a focus to see whether remote ischaemic preconditioning also has cardiac protective effect during heart valve surgery.

Official Title
-----------------
Effect of Remote Ischemia Preconditioning on Myocardial Injury in Patients Undergoing Heart Valve Surgery

Conditions
-----------------
Heart Valve Diseases

Intervention / Treatment
-----------------
* Procedure: remote ischaemic preconditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All heart valve diseases needing heart valve surgery. Exclusion Criteria: All four limbs existed ischemic condition
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: treatment<br>remote ischaemic preconditioning | Procedure: remote ischaemic preconditioning<br>* Remote ischaemic preconditioning consisted of three 5-min cycles of right upper arm ischaemia, which was induced by an automated cuff -inflator placed on the right upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated. There was a 5- to 10-min interval between completion of the remote ischaemic preconditioning protocol and initiation of bypass.Control patients had a deflated cuff placed on the right upper arm for 30 min.<br>|
| No Intervention: untreated<br>control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma troponin I level | The investigators will measure the plasma troponin I level in several time points before and after surgery in each patient. | with 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum creatinine |  | within 7 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatic heart disease, degenerated heart valve disease, heart valve prolapse
Genotype/Phenotype Correlation of Movement Disorders and Other Neurological Diseases

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to identify families with inherited neurologic conditions, especially movement disorders, to evaluate affected and unaffected individuals clinically, and to obtain blood samples for genetic analysis.

Detailed Description
-----------------
The purpose of this protocol is to identify families with inherited neurologic conditions, especially movement disorders, to evaluate affected and unaffected individuals clinically, and to obtain blood samples for genetic analysis.

Official Title
-----------------
Genotype/Phenotype Correlation of Movement Disorders and Other Neurological Diseases

Conditions
-----------------
Movement Disorders, Myoclonus, Nervous System Diseases, Tic Disorders, Tremor

Participation Criteria
=================
Eligibility Criteria
-----------------
Neurologic disease or movement disorders affecting 2 or more family members. No conditions in which phlebotomy is contra-indicated.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Family Studies, Genetic, Myoclonus, Tics, Tremor, Movement Disorders, Neurological Disease
Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)

Study Overview
=================
Brief Summary
-----------------
To examine the pharmacokinetics and distribution of oral hydroxyurea when administered as a single dose to lactating women

Official Title
-----------------
Hydoxyurea Exposure in Lactation: A Pharmacokinetics Study (HELPS)

Conditions
-----------------
Sickle Cell Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lactating females, ≥ 18.0 years of age, at the time of enrollment Willingness to limit the baby's exposure to hydroxyurea through breastmilk, such as healthy volunteers using the pump and dump technique or avoiding direct breastfeeding or collection of pumped milk for at least 8 hours after taking the hydroxyurea dose. This applies only to healthy controls or women with sickle cell who are not already taking hydroxyurea. Women with sickle cell already taking hydroxyurea may continue to breastfeed their infants. Exclusion Criteria: Persons with known allergies to hydroxyurea Failure to sign informed consent, or inability to undergo informed consent process Persons for whom it is not feasible or medically advisable to obtain the specimens necessary for this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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 |
| --- | --- | --- |
| Hydroxyurea Concentration | Hydroxyurea concentration for each collected specimen will be analyzed and summarized. | 31-Dec-2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hydroxyurea
Iatrogenic Impairment of Urethral Coitus Owing to Midurethral Sling Procedure in a Woman With Vaginal Agenesis.

Study Overview
=================
Brief Summary
-----------------
To report a case of impairment urethral coitus after the midurethral sling procedure

Detailed Description
-----------------
To report a case of impairment urethral coitus after the midurethral sling procedure.

Official Title
-----------------
Iatrogenic Impairment of Urethral Coitus Owing to Midurethral Sling Procedure in a Woman With Vaginal Agenesis.

Conditions
-----------------
Stress Urinary Incontinence, Vaginal Agenesis

Intervention / Treatment
-----------------
* Procedure: Cut the sling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: midurethral sling procedure for stress urinary incontinence woman with vaginal agenesis. Exclusion Criteria: Nil

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cut the sling|Cut the mid-urethral sling for stress urinary incontinence|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual function | Asking the patient whether she can resume sexual intercourse or not after surgery | 1 year |
EFFEXTS OF THE CLEANSWEEP SUCTION CATHETER

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the effectiveness of a closed suction system with an inflatable balloon on the catheter (Cleansweep system) to that of a standard closed suction system in terms of reducing the interior resistance of endotracheal tubes. Subjects who require frequent suctioning ( > every 2.5 hours) and who have stable cardiovascular systems will be randomized to receive suctioning either through the Cleansweep system or standard system initially followed by the corresponding system. The subjects will be suctioned every two hours for eight hours ( the first 2 suction procedures with one system followed by 2 with the other system). After each suction procedure measurements of resistance will be made using peak and plateau pressures. Analysis: For each patient, data for both procedures on each catheter system will be pooled and mean differences between the standard system and the Cleansweep system will be calculated. For all 20 patients the mean (+/- SD) of these differences will be calculated and significance will be sought using appropriate statistical tests. The study will be unblinded and randomization determines merely which system will used initially for the first 2 procedures.

Official Title
-----------------
EFFECTS OF TELEFLEX CATHETER (CLEANSWEEP) ON VENTILATOR MECHANICS

Conditions
-----------------
Endotracheal Tube Clearance

Intervention / Treatment
-----------------
* Device: Cleansweep
* Device: Halyard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intubated, mechanically ventilated patients who require suctioning more often than every 2.5 hours Exclusion Criteria: Unstable cardiovascular system (significant arrythmias, blood pressure support requiring > 2 pressors refractory hypoxemia (P/F ratio < 80)

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cleansweep closed suction system<br> | Device: Cleansweep<br>* The Cleansweep closed suction system<br>|
| Other: Halyard closed suction system<br> | Device: Halyard<br>* Halyard Closed Suction System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in endotracheal tube resistance during mechanical ventilation after 4 suction procedures | Measurements of resistance will be made following each suction procedure (2 with the Cleansweep system and 2 with the standard system) | 8 hours |
Effectiveness and Satisfaction With Brief Synchronous Tele-psychiatry Consult

Study Overview
=================
Brief Summary
-----------------
Will Tele-psychiatry be effective and acceptable to patients.

Detailed Description
-----------------
This pilot aims to provide tele-psychiatry consults to patients at regional Mayo Clinic Florida primary care sites. The primary aim of this study is to assess the impact of brief tele-psychiatry consults on depression and anxiety outcomes for patients enrolled in complex care management; the secondary aim is to assess patient satisfaction with brief tele-psychiatry consults.

Official Title
-----------------
Pilot to Assess Effectiveness of and Satisfaction With Brief Synchronous Tele-psychiatry Consult

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: Tele-psychiatry consult


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Enrolled in complex care management PHQ9 above 10 or GAD7 above 10. Exclusion Criteria Not able to provide informed consent Severe cognitive impairments or sensory deficits Not able to understand and speak English

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telepsychiatry Consult<br>One time tele-psychiatry consultation to provide treatment recommendations for patients primary care physician. | Behavioral: Tele-psychiatry consult<br>* tele-psychiatry consult for evaluation and treatment recommendations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Outcome | Will measure depression outcome by measuring PHQ9 score at baseline and 6 months after initial tele-psychiatry consult. | 6 month | 
| Anxiety Outcome | Will measure Anxiety outcome by using GAD7 score at baseline and 6 months after initial tele-psychiatry consult. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with tele-psychiatry consult | Assess patient satisfaction with tele-psychiatry consult at baseline visit by use of patient satisfaction questionnaire. | baseline visit |
Data Aquisition for Optimization of Coronary Artery Disease Algorithm

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to optimize an already existing algorithm for diagnosing atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).

Detailed Description
-----------------
Acoustic information from the heart is obtained from patients suffering from Coronary Artery Disease. The acoustic signals are evaluated as indicators for CAD.

Official Title
-----------------
Data Aquisition for Optimization of Coronary Artery Disease Algorithm

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: ProtoCAD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age minimum 18 years Referred to CAG on suspicion of CAD Stabile angina without ACS Signed informed consent Exclusion Criteria: ACS Previous bypass operation Previous heart transplant(incl. mechanical or artificial) Pregnancy Damaged skin on examination location

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 |
| --- | --- |
| Patients referred to CAG.<br>Sequential design with ProtoCAD and CAG | Device: ProtoCAD<br>* Aquiring acoustic signals from heart patients.<br>* Other names: Acarix CAD device.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity versus 1-specificity as a function of cut-off values on the 'Cardiac Noise Marker' scale here under Sensitivity by suitable cut-off value on the 'Cardiac Noise Marker' scale and Specificity with same cut-off value. |  | The first testday | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed differences in distribution of 'Cardiac Noise Marker' within three sub-groups. |  | The first testday |
Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response

Study Overview
=================
Brief Summary
-----------------
Observe the effect of terlipressin on renal function in patients with SHR type I adjusting the dose based on hemodynamic response.

Official Title
-----------------
Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response

Conditions
-----------------
Cirrhosis, Hepatorenal Syndrome Type I

Intervention / Treatment
-----------------
* Drug: Terlipressin and albumin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hepatorenal syndrome type 1. Signed informed consent. No exclusion criteria. At least 18 years old Negative pregnancy test in serum or urine in women of childbearing age, and agree to use adequate contraception since at least 14 days prior to the first dose of study drug until 14 days after the last. Exclusion Criteria: Hepatocellular carcinoma: exclusion of patients with hepatocellular carcinoma who present more than 3 nodules, single nodule larger than 5 cm, tumor portal thrombosis or extrahepatic tumor spread. Active bacterial infection with symptoms of systemic inflammatory response (fever, tachycardia, tachypnea, hypotension, septic or blood count). Cardiac or respiratory failure clinically significant. Clinically significant peripheral artery disease. A history of ischemic heart disease. Hypersensitivity to terlipressin and / or albumin or any of the excipients. Pregnancy. Septic shock. Chronic renal failure. Women in lactation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: terlipressin<br> | Drug: Terlipressin and albumin<br>* Terlipressin dose: 2mg/24h, it will be modified depending on: Arterial pressure increase < 10 mmHg and the creatinine values decrease <25%, it will be increased every 8 hours until reaching an increase of at least 10mmHg arterial pressure or a creatinine decrease of the 25%. Albumin: Initial dose (first day) of 1g/Kg (up to a maximum of 100g) and the following days from 20 to 40 g/day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in arterial pressure and creatinine |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasmatic renin activity and aldosterone and noradrenaline concentration. |  | 4 months | 
| Treatment-related adverse events |  | 4 months | 
| Hepatorenal Syndrome reversion due to hemodynamic changes. |  | 4 months |
Anger Expression, Self-focus and Coronary Heart Disease Risk Factors

Study Overview
=================
Brief Summary
-----------------
To identify behavioral factors underlying the development of cardiovascular risk in young adults.

Detailed Description
-----------------
BACKGROUND: The continued number of observations relating the Type A behavior pattern to coronary heart disease underscores the importance of developing a careful theoretical basis that may account for the virulent components of a coronary-prone personality. CARDIA or Coronary Heart Disease Risk Development in Young Adults is a prospective, epidemiological study of coronary heart disease risk factors in cohorts of Black and white men and women, 18 to 30 years of age. DESIGN NARRATIVE: From each of the baseline tape-recorded Type A/B structured interviews administered in CARDIA, eighteen questions were scored for self-references, perceived pressure, anger experience, and anger expression. The anger measures were related to other measures of anger-in and hostility in order to establish their validity. The interrelationships of these factors were assessed separately for each of the socioeconomic status (SES) categories. A major focus of the analyses was to describe SES differences in how pressure was perceived and how anger was experienced and expressed. The study also assessed how these factors were related to data already collected on psychosocial risk factors and primary risk factors including blood pressure, serum cholesterol, and cigarette smoking. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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