linjc16/ctgov huggingface dataset:
Brain Mechanisms Underlying the Effect of the Motilin Receptor Agonist Erythromycin on Hunger in Normal Weight Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the role of erythromycin, a prokinetic agent, on hunger, and the brain mechanism lying behind it.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Erythromycin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female only. Age > 18 and < 60. Body Mass Index (BMI) of 19-25 kg/m2 (no weight change of more than 5 kg in the past three months). Not known to have any chronic medical illness or illnesses affecting the gastrointestinal, cardiovascular, or nervous systems, chronic pain or psychiatric disorder. If female not known to be pregnant. Not known to have any past upper gastrointestinal surgery. Exclusion Criteria: Alcohol consumption > 7 drinks / week Major depression and chronic health conditions except controlled hypertension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>intravenous infusion | Drug: Placebo<br>* physiological saline<br>|
| Experimental: Erythromycin<br>intravenous infusion | Drug: Erythromycin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional brain images | The functional brain images will be taken via functional magnetic resonance imaging (fMRI), and be analysed via a software called SPM. | 40 min after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hunger scores | The hunger scores will be taken every 10 minutes since the scan starts via a 10 cm visual analogue scale. | every 10 minutes since the scan starts | 
| gut hormones | Peripheral blood samples will be taken every 10 min since the scan starts until the endpoint of the study to measure gut hormones (motilin, ghrelin, CCK, PYY, GLP-1) by radioimmuno-assay. | every 10 min since the scan starts |
EVITA: Evaluation of VIP Feature in Pacemaker Patients

Study Overview
=================
Brief Summary
-----------------
The primary efficacy objective of this clinical investigation is to demonstrate that the Ventricular Intrinsic Preference (VIP™) feature allows to reduce the medium- and long-term incidence of unnecessary ventricular pacing in patients with intact AV conduction.

Official Title
-----------------
EVITA: Evaluation of VIP Feature in Pacemaker Patients

Conditions
-----------------
Arrhythmia

Intervention / Treatment
-----------------
* Device: Device: St. Jude Medical Victory dual-chamber pacemaker
* Device: Ventricular Intrinsic Preference


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has an indication for implantation of a dual-chamber pacemaker; Patient is implanted or scheduled to be implanted with a St Jude Medical Victory pacemaker, or newer device with the same study relevant feature. Exclusion Criteria: Patient has persistent or permanent AF/AFl; Patient has permanent AV Block; Patient has a pacemaker replacement; Patient is in NYHA class IV; Patient is unable to attend the follow-up visits; Patient is pregnant; Patient is less than 18 years of age

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ventricular Instrinsic Preference (VIP) turned ON | Device: Device: St. Jude Medical Victory dual-chamber pacemaker<br>* Pacemaker implant<br>Device: Ventricular Intrinsic Preference<br>* Programming of pacemaker<br>|
| Active Comparator: 2<br>Ventricular Instrinsic Preference (VIP) turned OFF | Device: Device: St. Jude Medical Victory dual-chamber pacemaker<br>* Pacemaker implant<br>Device: Ventricular Intrinsic Preference<br>* Programming of pacemaker<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of ventricular pacing |  | 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with intact AV conduction
Haloperidol vs. Valproate in Agitation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the efficacy of haloperidol and valproate in management of people with agitation in emergency department

Official Title
-----------------
Haloperidol vs. Valproate in the Management of Agitated Patients Presenting to the Emergency Department: A Randomized Clinical Trial

Conditions
-----------------
Psychomotor Agitation

Intervention / Treatment
-----------------
* Drug: Haloperidol
* Drug: Valproate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of psychomotor agitation aged 18 to 65 years Exclusion Criteria: Pregnant patients Severe liver disease History of drug (haloperidol/valproate) allergy Readily amendable causes for the agitation (hypoxemia or hypoglycemia) Hypotension (systolic blood pressure (SBP) ≤ 90 mm Hg) Known history of liver disease or uncontrolled diabetes Noticeable or suspected head trauma Previous history of neuroleptic malignant syndrome Receiving psychotropic medication, neuroleptic agents or cholinesterase inhibitors at the time of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Haloperidol<br>Haloperidol 5mg intramuscular injection | Drug: Haloperidol<br> <br> * Other names: Haldol;|
| Active Comparator: Valproate<br>Valproate single Infusion; 400 mg (weigh<60 kg), 500 mg (weight>60 Kg) | Drug: Valproate<br> <br> * Other names: Depakene;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Agitated Behavior Scale (ABS) score | Patients were rated before medication administration and within 30 minutes afterwards according to Agitated Behavior Scale (ABS) score. Any statistically significant change in ABS score consider as positive effect of either intervention. | within the first 30 minutes of treatment onset |
Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the stability of uridine triphosphate (UTP) and examine the metabolism of exogenous nucleotides on airway epithelial surfaces in patients with cystic fibrosis. II. Determine the acute safety and efficacy of aerosolized UTP in children with cystic fibrosis.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients may be treated on any of three different regimens. Patients may be treated on more than one regimen, if they meet the eligibility requirements. Patients on regimen A are adults and receive uridine triphosphate (UTP) by inhalation, followed immediately by bronchoscopy. Patients on regimen B are children, aged 4 to 10 years. Patients receive up to 4 graded doses of UTP by inhalation on day 1. On day 2, patients receive a single dose of UTP. Patients receive amiloride followed by UTP by inhalation on day 3. Patients on regimen C are children, aged 4 to 18 years. Patients inhale a radiolabelled (technetium 99m) monodisperse iron oxide aerosol. Radiation deposited in the patient's lungs is monitored. Patients are randomized to receive one of 4 different aerosols (vehicle; UTP; amiloride; or UTP plus amiloride), which is inhaled for 20 minutes. Patients are followed 24 hours after aerosol exposure. Regimen D is a dose escalation study in which patients are aged 9 to 40 years. Patients receive either the vehicle or UTP by inhalation 3 times daily for 3 days. Cohorts of 4 patients each are entered at each dose level.

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: amiloride
* Drug: uridine


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of mild to moderate cystic fibrosis Small production of daily airway secretions Stable pulmonary course --Prior/Concurrent Therapy-- Radiotherapy: No radiation within 12 months to cause patient to exceed annual limits Other: No chronic medication for reactive airways disease At least 12 hours since inhaled beta-adrenergic agonists At least 24 hours since systemic theophylline --Patient Characteristics-- FEV1 greater than 50% predicted Other: Not pregnant Must perform reproducible spirometry

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: amiloride|nan|
|Drug: uridine|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
-----------------
cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease
Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)

Study Overview
=================
Brief Summary
-----------------
This study will determine the dose-response relationship of VAY736 for key efficacy and safety parameters

Official Title
-----------------
Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS)

Conditions
-----------------
Primary Sjogren Syndrome

Intervention / Treatment
-----------------
* Biological: VAY736
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfilled revised American European Consensus Group criteria for pSS Seropositive at screening for anti-Ro/SSA antibodies Screening ESSDAI value >=6 scored from 7 domains: articular, cutaneous, glandular, lymphoadenopathy, constitutional, biologic and hematologic. Exclusion Criteria: Secondary Sjogren's syndrome Use of other investigational drugs Active viral, bacterial or other infections Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at screening

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VAY736 dose 1<br>VAY736 low | Biological: VAY736<br>* VAY736<br>|
| Experimental: VAY736 dose 2<br>VAY736 medium | Biological: VAY736<br>* VAY736<br>|
| Experimental: VAY736 dose 3<br>VAY736 high | Biological: VAY736<br>* VAY736<br>|
| Placebo Comparator: Placebo<br>Placebo control | Other: Placebo<br>* Placebo control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in multi-dimensional disease activity | Dose response measured by change multi-dimensional disease activity as assessed by the physician | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient-reported disease activity measures | Dose response measured by change in patient-reported disease activity measures | 24 weeks | 
| Change in quality of life measure by PRO | Change in quality of life measure by patient reported outcome (PRO) | 24 weeks | 
| Change in salivary gland function measure by flow rate | salivary gland function measure by flow rate | 24 weeks | 
| Incidence of Adverse events and Serious Adverse Events | Number of participants with adverse events | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sjogren, VAY736, ianalumab, pSS
Diffusion-weighted Imaging Study in Cancer of the Ovary

Study Overview
=================
Brief Summary
-----------------
This project seeks to develop a quantitative imaging biomarker for evaluating and monitoring treatment response in ovarian cancer metastases and assess its potential in monitoring treatment response. This will involve standardising DW-MRI for the abdomen and pelvis across multiple centres and platforms, assessing reproducibility of the measurement in patients planned for neoadjuvant chemotherapy and assessing its utility as an early response biomarker in patients with platinum-sensitive relapse due to receive therapy with carboplatin. Scanning measurements will be correlated with histopathological markers in tumour samples in order to link the biomarker with response mechanisms.

Official Title
-----------------
Assessing Treatment Response of Peritoneal Metastases in Ovarian Cancer Using Diffusion Weighted Magnetic Resonance Imaging.

Conditions
-----------------
Ovarian Cancer, Peritoneal Metastases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed ovarian, primary peritoneal or fallopian tube cancer stage III or IV Scheduled to receive neoadjuvant chemotherapy (carboplatin/cisplatin)with planned debulking surgery. Exclusion Criteria: Life expectancy of less than 6 months MRI contraindications Low grade or heavily calcified disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biological validation cohort 1<br> | |
| Response assessment cohort 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of a Quantitative Imaging Biomarker for Evaluating Ovarian Cancer Metastases and Assessment of its Potential in Monitoring Treatment Response. | Diffusion-weighted magnetic resonance imaging (DW-MRI) for visualising peritoneal metastases will be developed.Reproducibility will be assessed in a multi-centre setting across multiple vendor platforms and field strengths by comparing 2 baseline scans per person and plotting absolute difference in ADC against mean of the 2 measurements.Biological validation will be achieved by correlating scan data (ADC change) following chemotherapy with histology of the tumour(amount of cell death) at surgery. | 4.0 years |
Effects of Exercise on Markers of Inflammation in Skeletal Muscle in Elderly Hip Fracture Patients

Study Overview
=================
Brief Summary
-----------------
Decreased skeletal muscle mass is a prevalent condition among the elderly, and an important cause of disability and functional decline. The declines in muscle mass associated with aging may be related to alterations in specific kinds of growth factors in the muscle. Elderly hip fracture patients often have significant decreases in muscle mass. The purpose of this study is to investigate whether an exercise program can induce changes in muscle growth factors that are associated with increases in muscle mass and strength in elderly hip fracture patients.

Conditions
-----------------
Hip Fractures, Muscular Atrophy

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrollment in HSC protocol #97-0695 Rehabilitation Intensification Post Hip Fracture Community-dwelling Hip fracture within 16 weeks of the screening assessment for protocol 97-0695 Persistent mobility and/or ADL impairments, but independent in ambulation Modified Physical Performance Test (PPT) score between 12 and 28

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Single Group Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Exercise|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
-----------------
sarcopenia
Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to collect information on the safety, especially serious infections and malignancies, and efficacy of the long-term use of ORENCIA Intravenous Infusion 250mg in patients with rheumatoid arthritis.

Official Title
-----------------
Outline of Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Orencia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are beginning to receive the treatment with ORENCIA Intravenous Infusion 250mg under the approved indications, dosage, and administration Have available HAQ data Have available DAS28-ESR or DAS28- CRP data Have no past or present history of malignancies Are expected to be followed up for 3 years

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 who use ORENCIA<br>Patients who use ORENCIA for the approved indications and who at the start of treatment | Drug: Orencia<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy measured by Patient's survival |  | 3 years | 
| Efficacy measured by development of malignancies after treatment discontinuation |  | 3 years |
Measurement of in Vivo Mitochondrial Capacity in Infants

Study Overview
=================
Brief Summary
-----------------
The overarching aim of this project is to determine the test re-test reliability of 31P-magnetic resonance spectroscopy measurements in infants. Primary endpoints include two separate measures of in vivo mitochondrial capacity (ATPmax) over a 1-10 day period to assess feasibility and reliability.

Official Title
-----------------
Measurement of in Vivo Mitochondrial Capacity in Infants: a 31P-MRS Pilot Study

Conditions
-----------------
Healthy Infants

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, full-term infant aged 14-28 days at Visit 1 willingness of parents to be notified of incidental findings from study procedures Exclusion Criteria: born preterm implanted metal or electronic objects that render MRI unsafe unable to complete 2 clinic visits 1-10 days apart at Pennington Biomedical Research Center

Ages Eligible for Study
-----------------
Minimum Age: 14 Days
Maximum Age: 28 Days

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In vivo mitochondrial capacity (ATPmax) | In vivo mitochondrial capacity as measured by phosphorus magnetic resonance spectroscopy | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mitochondria, MRI, neonates