linjc16/ctgov huggingface dataset:
EasyBand GOAL Trial

Study Overview
=================
Brief Summary
-----------------
Safety, effectiveness, and performance of Allergan's EasyBand telemetrically adjustable gastric banding device for the treatment of morbidly obese patients.

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Device: Easyband (Telemetrically adjustable gastric banding device)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum 3 year history of morbid obesity with documented failure of conservative, non-surgical means of weight reduction within 1 year prior to the screening visit; BMI >/= 40 kg/m2, or BMI >/= 35 kg/m2 and </= 40 kg/m2 with one or more significant medical conditions related to obesity; Candidate for surgical weight loss intervention Exclusion Criteria: Previous surgical treatment of obesity; Patient already implanted with a device sensitive to radiofrequency emissions (implantable pacemaker, implantable defibrillator, etc); Physical or emotional conditions that may prohibit surgery

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Easyband (Telemetrically adjustable gastric banding device)|EasyBand|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent excess weight loss (%EWL) |  | 5 years |
Short-term Effects Kinesiology Tape on Sitting Postural Control in Moderate and Severe Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
To analyze the short-term effect of kinesiology taping on sitting postural control in moderate and severe cerebral palsy

Official Title
-----------------
Short-term Effects Kinesiology Tape on Sitting Postural Control in Moderate and Severe Cerebral Palsy

Conditions
-----------------
Cerebral Palsy, Kinesiology Taping, Postural Control

Intervention / Treatment
-----------------
* Device: Kinesiology taping
* Other: Conventional physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 4 and 14 years diagnosis of motor and cognitive disability have prescribed physiotherapy treatment at school acquisition of autonomous sitting sign the consent informed Exclusion Criteria: presentation of an allergic reaction to tape presentation of wounds in the area of application of the tape having received botulinum toxin treatment in the last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 14 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinesiology taping<br>Apply a kinesiology taping on the abdominal muscles plus conventional physiotherapy | Device: Kinesiology taping<br>* We used kinesiology taping in abdominal muscles<br>|
| Active Comparator: Physiotherapy Group<br>Apply a conventional physiotherapy | Other: Conventional physiotherapy<br>* We used conventional physiotherapy to comparate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posture and Postural Ability Scale - T0 | Posture and Postural Ability Scale pre-intervention (PPAS pre). Score from 0 to 7, and the higher the score, the better posture | pre-intervention | 
| Posture and Postural Ability Scale - T1 | Posture and Postural Ability Scale post-intervention (PPAS post). Score from 0 to 7, and the higher the score, the better posture | at 10 days | 
| Segmental Assessment of Trunk Control - T0 | Segmental Assessment of Trunk Control pre-intervention (SATco pre). Score from 1 to 7, and the lower the score, the better balance | pre-intervention | 
| Segmental Assessment of Trunk Control - T1 | Segmental Assessment of Trunk Control post-intervention (SATco post).Score from 1 to 7, and the lower the score, the better balance | at 10 days |
Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine wether topical rapamycin is more efficient than topical steroids in the treatment of chronic erosive lichen planus.

Official Title
-----------------
Efficacy of Topical Rapamycin in Treatment of Chronic Erosive Oral Lichen Planus. Double Blind Randomised Controlled Trial Rapamycin vs Topical Steroids

Conditions
-----------------
Oral Lichen Planus

Intervention / Treatment
-----------------
* Drug: TOPICAL SIROLIMUS (RAPAMUNE*)
* Drug: TOPICAL BETAMETHASONE 0.05%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Oral Lichen Planus Oral Erosive Area More Than 1cm² Lichen Planus Pathologically Proven Exclusion Criteria: No Previous Treatment by Rapamycin Non Child Bearing Or Breast Feeding Woman Patient Who Cannot Be Treated By Rapamycin Or Betamethasone Chronic Renal Insufficiency (Creatinin Clearance < 40ml/Mn) Ongoing Treatment By Topical Calcineurin Inhibitors Or Systemic Steroids Or Retinoids Or Systemic Immunosuppressors Or Thalidomide Or Griseofulvin Or Antimalarials Cholesterolemia >7.8 Mmol/L Or Hypertriglyceridemia >3.95mmol/L Non Responsive To Medical Treatments Leucopenia (<3000/Mm3) Thrombopenia (<100 000/Mm3) Hypertransaminasemia (>3n) Hypersensitivity To Macrolides

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: T<br>TOPICAL SIROLIMUS AND PETROLATUM IN ORABASE | Drug: TOPICAL SIROLIMUS (RAPAMUNE*)<br>* APPLICATION ON THE LESIONS OF TOPICAL SIROLIMUS (RAPAMUNE*)1mg/ml bid during 3 months<br>|
| Active Comparator: C<br>TOPICAL BETAMETHASONE 0.05% in ORABASE AND PHOSAL | Drug: TOPICAL BETAMETHASONE 0.05%<br>* APPLICATION ON THE LESIONS OF TOPICAL BETAMETHASONE (DIPROLENE*)0.05% bid during 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COMPLETE CLEARING OF ORAL EROSIVE LESIONS |  | THREE MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| REGRESSION OF EROSIVE SURFACE AREA |  | THREE MONTHS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral lichen planus, chronic inflammatory, mucous membranes, erosive lesions
Phenylephrine Versus Ephedrine in Pre-eclampsia

Study Overview
=================
Brief Summary
-----------------
Phenylephrine administration is associated with reductions in CO and SctO2 compared with ephedrine when used for blood pressure management in women with pre-eclampsia undergoing cesarean delivery under spinal anesthesia.

Official Title
-----------------
Impact of Vasopressor Administration on Maternal and Neonatal Outcomes in Women With Pre-eclampsia

Conditions
-----------------
Pre-eclampsia

Intervention / Treatment
-----------------
* Drug: Phenylephrine
* Drug: Ephedrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking Age ≥18 yrs Pre-eclampsia (mild, or severe) Non-laboring women CD under spinal anesthesia Exclusion Criteria: Height < 5'0 Allergy to phenylephrine or ephedrine, or any other standardized medication Severe Cardiac disease in pregnancy with marked functional limitations (NYHA Class III and IV) Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants History of recent amphetamine or cocaine use. Subject enrollment in another study involving a study medication within 30 days of CD Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phenylephrine<br>Phenylephrine for maintaining blood pressure within 10 % of baseline | Drug: Phenylephrine<br> <br> |
| Active Comparator: Ephedrine<br>Ephedrine for maintaining blood pressure within 10 % of baseline | Drug: Ephedrine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Tissue Oxygen Saturation |  | Intraoperative from spinal placement till 10 min after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Output |  | Intraoperative from spinal placement till 10 min after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarean delivery, Spinal Anesthesia
Evaluation of the Repeatability and Reproducibility of AngioVue

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the repeatability and reproducibility of measurements of the vascular structures and the anatomical structures of the posterior pole of the eye based on AngioVue volume scans in normal subjects, glaucoma patients, and retina patients.

Conditions
-----------------
Normal, Glaucoma & Retinal Pathology

Intervention / Treatment
-----------------
* Device: Optical Coherence Tomography Angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal Age > 18. No retinal pathology or glaucoma. Glaucoma patient Age > 18. Have glaucoma. Retina patient Age > 18. Have retina pathology. Exclusion Criteria: Normal Unable to complete required exams. Poor quality image data. Glaucoma patient Unable to complete required exams. Poor quality image data. Retinal pathology. Retina patient Unable to complete required exams. Poor quality image data. Glaucoma.

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 |
| --- | --- |
| Normal<br>Not having glaucoma or retinal pathology | Device: Optical Coherence Tomography Angiography<br> <br> |
| Glaucoma<br>Having glaucoma. | Device: Optical Coherence Tomography Angiography<br> <br> |
| Retina<br>Having retinal pathology | Device: Optical Coherence Tomography Angiography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retina vasculature |  | Day 1 |
Pilot Study to Evaluate the Clinical Utility of Auscultation Software at Remote Locations

Study Overview
=================
Brief Summary
-----------------
Primary Objective: Evaluation of the utility of real-time, scope-to-scope communication between commercially-available 3M Littmann Electronic Model 3200 Electronic stethoscopes over a dedicated intranet system for the assessment of patients at remote (satellite) clinic locations by centrally-located (hub) medical providers. Secondary Objective: Comparison of the accuracy of patient assessment between the remotely located, mid-level presenter with the centrally-located physician or nurse practitioner provider.

Official Title
-----------------
Pilot Study to Evaluate the Clinical Utility of 3M Littmann Scope-to-Scope Software for Real-time Assessment of Patients at Remote Clinic Locations by Centrally-located Medical Providers

Conditions
-----------------
Auscultation of Heart and Lungs

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects who are at least 18 years of age Subjects who are scheduled to undergo examination in a telemedicine setting Subjects who are willing to voluntarily sign the compound Informed Consent and the Authorization to Disclose Protected Health Information Form. Exclusion Criteria: Subjects who are unwilling to undergo additional examination in a telemedicine setting, Any subject requiring time-critical medical intervention. Any subject who the investigator believes should not be included or is unsuitable for inclusion in the study.

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 |
| --- | --- |
| Primary Care Patients<br>Any patient undergoing a telemedicine evaluation involving auscultation of the heart and lungs. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmation of hub (remote) observations with satellite (local) observations | Presence or absence of heart or lung sound; e.g., murmurs, etc., and/or rales, rhonchii, wheezes. | 30 minutes |
Nor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Syndrome

Study Overview
=================
Brief Summary
-----------------
Hepatorenal syndrome is a functional renal impairment occurring in cirrhotic patients . It develops secondary to splanchnic arterial vasodilatation which decreases the effective blood volume, activate the renin-angiotensin-aldosterone system, and stimulate of sympathetic nervous system.This study aims to compare the efficacy of nor-epinephrine versus midodrine/ octreotide, together with intravenous albumin on renal functions of patients with hepatorenal acute kidney injury.

Official Title
-----------------
Nor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Acute Kidney Injury

Conditions
-----------------
Hepato-Renal Syndrome

Intervention / Treatment
-----------------
* Drug: Midodrine/Octreotide
* Drug: Nor-epinephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both sexes aged 18 years or older having cirrhosis, ascites, and a diagnosis of HRS-AKI based on the 2015 International Club of Ascites (ICA) diagnostic criteria Exclusion Criteria: Serum creatinine (sCr) >7 mg/dL Hypotension (mean arterial pressure (MAP) <70 mm Hg) or sepsis. Recent treatment with vasopressors. Patients with severe cardiovascular disease Known allergy to study medications

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Midodrine/Octreotide<br>oral midodrine plus octreotide as subcutaneous injection | Drug: Midodrine/Octreotide<br>* oral midodrine plus octreotide as subcutaneous injection<br>* Other names: albumin at doses of 20 to 40 g/day;|
| Active Comparator: Nor-epinephrine<br>Intravenous infusion norepinephrine | Drug: Nor-epinephrine<br>* Intravenous infusion norepinephrine<br>* Other names: albumin at doses of 20 to 40 g/day;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full response | the proportion of patients achieved full response defined as return of serum creatinine to a value within 0.3 mg/dl of the baseline value | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial response | defined as a regression of at least one acute kidney injury stage with a fall in the serum creatinine value to ≥0.3 mg/dl above the baseline serum creatinine value | 10 days | 
| Reversal | Incidence of HRS reversal defined as at least one serum creatinine value of ≤ 1.5 mg/dl while on treatment. | 10 days |
A Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine Reward

Study Overview
=================
Brief Summary
-----------------
GSK598809 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. This study will asses the effects of a single dose of GSK598809 in modulating nicotine reward in 2 cohorts of otherwise healthy male volunteers who smoke. Each cohort of subjects will receive a single dose of placebo or GSK598809 in two dosing sessions binded crossover fashine. There will be a washout period of at least seven days between each session.

Official Title
-----------------
A Randomized, Double-bind, Placebo Controlled, Two-way Cross-over Study to Assess the Effects of a Single Dose of GSK598809, a Selective DRD3 Antagonist, in Modulating Nicotine Reward

Conditions
-----------------
Substance Dependence

Intervention / Treatment
-----------------
* Drug: GSK598809


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male smokers aged 18-65 with a desire to quit smoking. Body weight greater than 50kg and BMI within range 19 - 29.9 kg/m2 Healthy with no significant medical, psychiatric or laboratory evaluation abnormality. Exclusion Criteria: Positive pre-study urine drug/breath alcohol screen: positive HIV 1/2, Hepatitis B or Hepatitis C test at screening. History of alcohol/drug abuse or dependence (other than nicotine) within 12 months of the study. History of psychiatric disorder or sensitivity to any of the study medications or components thereof or a history of drug or allergy that in the opinion of the physician responsible contraindicates their participation. History of cardiac or pulmonary disease/abnormalities.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GSK598809<br>Drug | Drug: GSK598809<br>* Drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | through 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroop test |  | through 10 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacodynamics,, pharmacokinetics,, tolerability,, Safety,, single dose,, placebo,, Nicotine reward, GSK598809
Incretin Effect in Lean and Obese Subjects

Study Overview
=================
Brief Summary
-----------------
The incretin effect is markedly reduced in patients with type 2 diabetes. Data support the notion that this deficiency is a consequence of the diabetic state. However, the impact of insulin resistance on the incretin effect in obese individuals who uphold a normal glucose tolerance (NGT) despite their insulin resistant state remains to be elucidated. The primary aim of the present study is to evaluate the separate impact of one of the cornerstones of type 2 diabetic pathophysiology, namely insulin resistance, on the incretin effect in lean and obese patients with type 2 diabetes and in two matched normal-glucose tolerant groups of healthy control subjects.

Official Title
-----------------
The Impact of Obesity and Insulin Resistance on the Incretin Effect in Patients With Type 2 Diabetes and Healthy Subjects

Conditions
-----------------
Incretin Effect, Insulin Resistance, Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: Oral glucose tolerance test (OGTT)
* Other: Isoglycemic intravenous glucose infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with type 2 diabetes for at least 3 months Normal blood hemoglobin Informed consent Exclusion Criteria: Liver disease Diabetic nephropathy Treatment with medication that can not be stopped for 12 hours

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese patients with type 2 diabetes<br>Patients with type 2 diabetes and BMI>33 | Other: Oral glucose tolerance test (OGTT)<br> <br> Other: Isoglycemic intravenous glucose infusion<br> <br> |
| Obese subjects with normal glucose tolerance<br>Subjects with normal glucose tolerance and BMI>33 | Other: Oral glucose tolerance test (OGTT)<br> <br> Other: Isoglycemic intravenous glucose infusion<br> <br> |
| Lean subjects with type 2 diabetes<br>Patients with type 2 diabetes and BM<25 | Other: Oral glucose tolerance test (OGTT)<br> <br> Other: Isoglycemic intravenous glucose infusion<br> <br> |
| Lean subjects with normal glucose tolerance<br>Subjects with normal glucose tolerance and BM<25 | Other: Oral glucose tolerance test (OGTT)<br> <br> Other: Isoglycemic intravenous glucose infusion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incretin effect |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance |  | 2 days |