linjc16/ctgov huggingface dataset:
Effect of Peripheral Electrical Stimulation (PES) on Brain Response to Glucose Stimuli

Study Overview
=================
Brief Summary
-----------------
The aims of this study are twofold: (1) to develop an innovative approach for studying brain glucose metabolism using functional diffusion weighted imaging (DWI) and BOLD fMRI in humans; (2) to evaluate the effect of short peripheral electrical stimulation (PES) treatment on brain and brain-stem targets, associated with control of food intake and energy expenditure, in response to glucose stimuli, in healthy volunteers.

Official Title
-----------------
Effect of Short Peripheral Electrical Stimulation (PES) on Brain Response to Glucose Stimuli Evaluated by BOLD and Functional Diffusion MRI: a Crossover Pilot Study

Conditions
-----------------
Brain Activity, Glucose Control

Intervention / Treatment
-----------------
* Device: Stimulator
* Dietary Supplement: Glucose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Age 18-65 years old. Body mass index 18 to 25 kg/m2 Capable of giving informed consent Exclusion Criteria: Pregnancy, or nursing Permanent pacemakers Metal prosthesis Skin disease Claustrophobia History of neurological disorders

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucose<br>Glucose ingestion | Dietary Supplement: Glucose<br>* 300ml tap water with 75g glucose<br>|
| Active Comparator: PES<br>Single session of short PES treatment before glucose ingestion. | Device: Stimulator<br> <br> Dietary Supplement: Glucose<br>* 300ml tap water with 75g glucose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in postprandial cerebral blood flow (fMRI) and cerebral diffusivity (fDWI) in response to glucose ingestion. |  | changes from baseline to 30 minutes after glucose ingestion |
Inspiratory Flow and Volumes in Bronchiectatics

Study Overview
=================
Brief Summary
-----------------
Adequate administration of drugs via dry powder inhalers is dependent on adequate inspiratory flow rates and volumes. These vary according to the device being used and its resistance. The dry powder inhaler device under investigation is a device approved by the Therapeutic Goods Administration (ARTG no. 196255) for use with dry powder mannitol. Dry powder mannitol is currently being investigated as a treatment for bronchiectasis. We wish to measure the inspiratory flow characteristics of both the low and high resistance devices amongst a group of subjects with bronchiectasis. We propose that the majority of subjects investigated with varying lung function will achieve adequate flow during a controlled inspiration.

Official Title
-----------------
Inspiratory Flow Rates and Volumes in Subjects With Bronchiectasis Using Low and High Resistance Dry Powder Inhaler Devices

Conditions
-----------------
Bronchiectasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-cf bronchiectasis aged 18-80 inclusive FEV1 greater or equal to 50% predicted and greater or equal to 1L Exclusion Criteria: uncontrolled asthma CF bronchiectasis have any condition for which spirometry measurement would be contraindicated

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>subjects with bronchiectasis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inspiratory flow |  | single visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inspiratory volume |  | single visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
measure inspiratory spirometry with dry powder inhaler device in series with the spirometer
Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess if a combination of everolimus, steroids, and mycophenolate mofetil is associated with a better renal function than sirolimus.

Official Title
-----------------
A Single Arm, Prospective, Open-label, Pilot Study to Assess Effects of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: Everolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First or second renal transplantation (1 to 10 years post-transplant) Treatment with sirolimus + mycophenolate mofetil + steroids + ACE inhibitor or angiotensin II receptor antagonist + statin Exclusion Criteria Treatment with a CNI or azathioprine Vascular rejection or biopsy-proven acute rejection within 3 months prior to screening Severe dyslipidemia Other protocol-defined inclusion / exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function at M6 (glomerular filtration and tubular function). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function (other tubular function parameters) |  |  | 
| Incidence of biopsy-proven acute rejections and CMV infections |  |  | 
| Laboratory parameters: hemoglobin, WBC, T-cell sub-populations, platelets, transaminases, total cholesterol, HDL and LDL cholesterol, apolipoproteins A1 and B, triglycerides, fasting glucose, HbA1c, LH, FSH, testosterone and TSH |  |  | 
| Mucous and cutaneous disorders |  |  | 
| Adverse events and serious adverse events, premature study treatment discontinuations. |  |  | 
| Monitoring of everolimus trough levels. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal transplantation, maintenance, switch, everolimus, CNI-free
Evaluation of Balance Reactions of Transfemoral Amputees Using the Virtual Analysis System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test and compare the balance reactions of Tranfemoral Amputees and able bodied subjects in response to perturbations given by a highly advanced Virtual Reality system.

Official Title
-----------------
Evaluation of Balance Reactions of Transfemoral Amputees Using the Virtual

Conditions
-----------------
Balance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Transfemoral Amputees, walking without any assistive device, at least one year. Exclusion Criteria: Amputees who suffer from a Neurological Injury/ disease that has implication on balance control. Amputees who suffer from Orthopedic Injury that has implication on balance control. Amputees who suffer from Cardiology disease that has implication on balance reactions.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| 1<br>Transfemoral Amputees using the C- Leg knee. | |
| 2<br>Transfemoral Amputees using a Multiaxial Knee. | |
| 3<br>Able bodied. | |

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
-----------------
Trans Femoral Amputees Balance Reactions
Motion Analysis and Assessment of Cardiac Function for Cardiac Images

Study Overview
=================
Brief Summary
-----------------
The study develops software for motion analysis and assessment of cardiac function for cardiac images. Cardiac catheterization ventriculography of several randomly selected patients were taken from our hospital's PACS system. The investigators remove the patient information on the images, and use the image for motion analysis and assessment.

Detailed Description
-----------------
The study develops software for motion analysis and assessment of cardiac function for cardiac images. Twenty patients who have both cardiac catheterization ventriculography and cardiac echo studies will be randomly selected. Cardiac catheterization ventriculography of the selected patients were taken from our hospital's PACS system. The investigators remove the patient information on the images, and use the image for motion analysis and assessment. The results will be compared and correlated with their cardiac echo, which could validate the clinical usefulness of the software.

Official Title
-----------------
Motion Analysis and Assessment of Cardiac Function for Cardiac Images

Conditions
-----------------
Heart; Functional Disturbance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who already have cardiac catheterization ventriculography and cardiac echo studies. Exclusion Criteria: patients who do not have either cardiac catheterization ventriculography or cardiac echo studies.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal heart function<br>normal heart function | |
| abnormal heart function<br>abnormal heart function | |

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
-----------------
Heart Wall Motion Function
Arimidex in McCune Albright Syndrome

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with McCune-Albright Syndrome.

Official Title
-----------------
An Open-label Study Evaluating the Safety and Efficacy of Anastrozole™ (ARIMIDEX) in the Treatment of Precocious Puberty in Girls With McCune-Albright Syndrome

Conditions
-----------------
McCune-Albright Syndrome

Intervention / Treatment
-----------------
* Drug: Arimidex 1 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed written consent of parent/legal guardian and subject assent (as needed by local requirements) females less than or equal to 10 years of age diagnosed with McCune-Albright Syndrome have progressive precocious puberty Exclusion Criteria: Any one of the following is regarded as a criterion for exclusion from the study: any prior treatment of MAS associated with progressive precocious puberty with a third generation aromatase inhibitor (anastrozole, letrozole, exemestane) in which no clinical response was seen concomitant treatment of precocious puberty associated with MAS, with the exception of bisphosphonates for polyostotic fibrous dysplasia and LHRH analogues in the case of central precocious puberty liver function tests at screening visit (AST, ALT) > or = 3x the upper limit of the reference range for age known hypersensitivity to any component of study medication

Ages Eligible for Study
-----------------
Maximum Age: 10 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Arimidex 1 mg<br>* Arimidex (anastrozole) 1mg once daily by mouth<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of study treatment will be assessed based on the change from baseline measurements relating to vaginal bleeding, bone age, and growth velocity |  | 12 months or until the subject demonstrates the lack of efficacy bases upon progression of primary endpoints or experiences serious drug-related toxicity requiring withdrawal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MAS, vaginal bleeding, advanced bone age, fibrous dysplasia, McCune-Albright Syndrome
Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of RGZ in healthy subjects.

Official Title
-----------------
Effect of Atazanavir Administered With and Without Ritonavir on the Pharmacokinetics of the Cytochrome P450 2C8 Substrate Rosiglitazone in Healthy Subjects

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Rosiglitazone maleate
* Drug: Atazanavir Sulphate
* Drug: Atazanavir Sulphate + Rosiglitazone maleate
* Drug: Atazanavir Sulphate + Ritonavir
* Drug: Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Rosiglitazone maleate<br>* Tablets, Oral, RGZ 4 mg, once daily, 1 day.<br>|
| Active Comparator: B<br> | Drug: Atazanavir Sulphate<br>* Capsules, Oral, ATV 400 mg, once daily, 5 days.<br>* Other names: Reyataz;|
| Active Comparator: C<br> | Drug: Atazanavir Sulphate + Rosiglitazone maleate<br>* Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.<br>* Other names: Reyataz;|
| Active Comparator: D<br> | Drug: Atazanavir Sulphate + Ritonavir<br>* Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.<br>* Other names: Reyataz;|
| Active Comparator: E<br> | Drug: Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate<br>* Capsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.<br>* Other names: Reyataz;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of Rosiglitazone in healthy subjects. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of Rosiglitazone and Atazanavir coadministration with and without Ritonavir. |  |  | 
| To explore the relationship between Atazanavir exposure, CYP2C8 genotype and the pharmacokinetics of Rosiglitazone exposure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV
Biological Rhythms and Vestibular System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the relationship between the vestibular system and chronobiology

Detailed Description
-----------------
The purpose of this study is to study the relationship between the vestibular system and chronobiology. Two parts will be performed. In the first one patients with bilateral vestibular areflexia will be compared to control subjects. In the second the effect of vestibular stimulation on circadian rhythms will be evaluated

Official Title
-----------------
Biological Rhythms and Vestibular System

Conditions
-----------------
Unspecified Disorder of Vestibular Function, Bilateral

Intervention / Treatment
-----------------
* Behavioral: vestibular stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No treatment changing vigilance/wakefulness Moderate caffein uptake (2 to 3 cups a day) Moderate smoker (5 cigarettes a day) Regular sleeping habits Exclusion Criteria: Sleeping duration <6 hours or >9 hours Night workers Pregnancy Sleep or wakefulness disorders Progressive neurodegenerative disorders Progressive psychiatric disorders Thyroid disease Type 1 diabetes Not able to practice physical activity Drug or alcohol addiction during the last 6 months

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>Control without vestibular stimulation | |
| No Intervention: Bilateral areflexia<br>Patient with vestibular bilateral areflexia | |
| No Intervention: Areflexia controls<br>Controls for patients with vestibular bilateral areflexia, matched in sex and age | |
| Experimental: vestibular stimulation<br>Subjects submitted to vestibular stimulation in order to improve circadian rhythms | Behavioral: vestibular stimulation<br>* Physical activity and vestibular stimulation will be used in order to improve circadian rhythms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements of vestibular reflexes (ocular and spinal) and circadian rhythms of biological functions. | Gain of vestibular ocular reflex Amplitude of vestibular spinal reflex Amplitude and phase of temperature circardian rhythms | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circadian Rhythm, Exercise, Reflex, Vestibular Ocular, Postural Balance
Intra-carotid Anesthetic Agent Delivery

Study Overview
=================
Brief Summary
-----------------
Intra-Carotid delivery of propofol.

Detailed Description
-----------------
Propofol injection into carotid artery . detection of response of experimental subjects to pain

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 5 experimental animals (rabbits) Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 10 Weeks
Maximum Age: 2 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Intracarotid injection of propofol to detect efficacy and safety as a novel route for drug delivery | Drug: propofol<br>* intracarotid propofol as an anesthetic agent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect on painful stimulus perception on HR measurement |  | 30 minutes |
The Relationship Between Pet Therapy and Well-being in Geriatric Rehabilitation In-patients

Study Overview
=================
Brief Summary
-----------------
In -patients in a geriatric rehabilitation unit, will participate in structured therapy with guinea-pigs on the assumption that the therapy will reduce anxiety and improve the outcome of their rehabilitation.

Detailed Description
-----------------
Measurement of anxiety before and after pet therapy using standardized questionaire.

Official Title
-----------------
The Relationship Between Pet Therapy and Well Being in Geriatric Rehabilitation In-patients

Conditions
-----------------
Cerebrovascular Accident, Hip Fracture

Intervention / Treatment
-----------------
* Behavioral: care of guinea pigs
* Behavioral: guinea pigs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: willingness to touch the pets,- Exclusion Criteria: blindness,deafness,aphasia, lack of knowledge of hebrew language,allergy or phobia to animals.MMSE less than 21,duration of admission lessthan two weeks.-
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: care of guinea pigs<br>Each patient serves as own control receiving pet therapy and usual occupational therapy on alternate days. | Behavioral: care of guinea pigs<br>* twice weekly sessions of care with guinea pigs<br>Behavioral: guinea pigs<br>* twice weekly pet therapy and twice weekly usual  occupational therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between pet-therapy and well-beingamong geriatric rehabilitation in-patients | use of validated questionaires to measure mood,anxiety and quality of life before and after the pet therapy | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety score |  | two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pet-therapy, guinea-pigs, rehabilitation, elderly