linjc16/ctgov huggingface dataset:
Cue Exposure Training for Overweight Children

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to investigate the effectiveness of two intensive two-session trainings, the conventional psycho-education and food cue exposure, on eating in the absence of hunger, binge eating and Body Mass Index (BMI) change in overweight/ obese children.

Official Title
-----------------
Cue Exposure Training for Overweight Children

Conditions
-----------------
Obesity, Overweight

Intervention / Treatment
-----------------
* Behavioral: Food cue exposure
* Behavioral: Psycho-education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being a patient in the Maastricht University Medical Center COACH unit for obese children and adolescents. Overweight, according to the sex and age specific cut-off point for overweight in children, as defined by Cole and colleagues (2000). Age: 12 - 18 years Exclusion Criteria: Not being overweight (anymore, due to weight loss) Not able to speak and/or write Dutch

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Food cue exposure<br> | Behavioral: Food cue exposure<br>* Participants will be exposed to several kinds of their favorite food. The aim of this exposure is to increase the food cravings as much as possible.<br>|
| Active Comparator: Psycho-education<br> | Behavioral: Psycho-education<br>* General information about nutrients, calories, exercise and the energy balance will be provided. In addition, psychological problems that accompany overweight will be discussed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating in the absence of hunger | Self-reported & behaviourally measured eating in the absence of hunger | 2 - 3 months | 
| Binge eating | Self-reported binge eating | 2 - 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cue reactivity | Reactivity to food related cues, measured by food cravings and salivary responses | 2 - 3 months | 
| Self-control and self-esteem | Self-reported self-control and self-esteem | 2 - 3 months | 
| Dietary restraint, and eating, weight and shape concerns | Self-reported dietary restraint, and eating, weight and shape concerns | 2 - 3 months | 
| BMI change | Body Mass Index change | 2 - 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cue exposure, childhood, overeating, overweight, obese, treatment
Probiotic Treatment in Juvenile Idiopathic Arthritis (JIA)

Study Overview
=================
Brief Summary
-----------------
This study investigates the efficacy of probiotic VSL#3 as an add on standard care on the activity of the disease in patients with Juvenile Idiopathic Arthritis.

Detailed Description
-----------------
Juvenile Idiopathic Arthritis (JIA) is the most frequent rheumatic disorder in children. Numerous studies suggest that alteration of the intestinal barrier may induce abnormal immune responses implicated in development or persistence of arthritis. This paves the way to new therapeutic options aiming to reestablish intestinal homeostasis to treat arthritis or to prevent disease flares. This study investigates the efficacy of probiotic VSL#3 as an add on standard care on the activity of the disease in patients with Juvenile Idiopathic Arthritis.

Official Title
-----------------
Evaluation of the Effectiveness of a Probiotic Treatment on Clinical Activity, Relapse Rates and Modification of the Intestinal Microbiota in Patients With Juvenile Idiopathic Arthritis (JIA)

Conditions
-----------------
Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Dietary Supplement: VSL#3
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥1year and <7years Patients with oligoarthritis and polyarthritis with rheumafactor negative and antinuclear antibodies (ANA) positive JIA with onset before the age of 6 years Exclusion Criteria: Change of JIA forme

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 7 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: Probiotic VSL#3<br> | Dietary Supplement: VSL#3<br>* Dietary Supplement<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the impact of a regular intake of probiotic VSL#3 in addition to standard treatment in patients with JIA on the clinical activity | American College of Rheumatology Pédiatrique score (ACR Pedi ) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the impact of a regular intake of probiotic VSL#3 in addition to standard treatment in patients with JIA on the intestinal microbiota. | Stool samples for intestinal microbiota analyses | 3 months |
Evaluate the Efficacy and Safety of TGR-1202 in Patients With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy

Study Overview
=================
Brief Summary
-----------------
This is a Phase 2, open-label, study of TGR-1202, a PI3K delta inhibitor, administered as a single agent in Chronic Lymphocytic Leukemia (CLL) patients who are intolerant to prior BTK inhibitors (ibrutinib, other) or prior PI3K delta inhibitors (idelalisib, other)

Official Title
-----------------
A Phase 2 Study to Assess the Safety and Efficacy of TGR-1202 in Patients With Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK (Bruton Tyrosine Kinase) or PI3K-Delta (Phosphoinositide-3-kinase) Inhibitor Therapy

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: TGR-1202


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) Discontinuation on prior BTK inhibitor or PI3K delta inhibitor due to adverse events within prior 9 months Presence of measurable disease Exclusion Criteria: Progression on prior BTK or PI3K delta inhibitor Prior treatment with TGR-1202 Richter's transformation or CLL transformation to aggressive lymphoma

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: TGR-1202<br>Oral daily dose of TGR-1202 | Drug: TGR-1202<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival |  | From date of enrollment until the date of first documented progression, assessed up through 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLL
Optical Coherence Tomography and Optic Neuritis (OCTON)

Study Overview
=================
Brief Summary
-----------------
Optic neuritis (ON) can remain isolated or reveal a widespread and chronic disease of the central nervous system (CNS), a multiple sclerosis (MS) or, more rarely, a Devic's neuromyelitis optica (NMO) or a systemic disease. The optical coherence tomography (OCT) is a retinal imaging technique to measure the thickness of the retina and its different layers with an accuracy of 4-6 µM. Costello et al have shown that approximately 75% of 54 MS patients have developed within 3 to 6 months after a ON a loss of 10 to 40 µM in the thickness of the peripapillary retinal nerve fiber layer (RNFL). The etiologic diagnosis of ON has been transformed in recent years. MS can now be diagnosed by McDonald's MRI criteria and NMO by the AQP4 antibodies (anti-aquaporin- 4) antibodies and the anti-MOG (myelin-oligodendrocyte glycoprotein) antibodies. The diagnosis and prognosis value of the OCT in patients with ON is not well known

Official Title
-----------------
Optical Coherence Tomography for the Etiological Diagnosis of Inflammatory Optic Neuritis

Conditions
-----------------
Optical Neuritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first onset of an optical neuritis lasting for less than 3 months Exclusion Criteria: Contra-indication to MRI Patient opposed to participation in the study Pregnant or lactating woman Patient under a measure of legal protection Absence of affiliation to social security or universal health coverage (CMU)

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

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 |
| --- | --- | --- |
| Sensitivity of the OCT, expressed as a percentage, for the etiological diagnosis of optical neuritis |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
First onset of optical neuritis
Tongxinluo Capsule for Coronary Microvascular Disease

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy and safety of Tongxinluo in patients with microvascular angina pectoris. Long-term follow-up of 1 to 5 years will be performed to evaluate the effect of Tongxinluo on long-term adverse cardiovascular events in patients with coronary microvascular disease.

Official Title
-----------------
The Efficacy and Safety of Tongxinluo Capsule in Patients With Coronary Microvascular Disease

Conditions
-----------------
Coronary Microvascular Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks; Coronary normal or stenosis < 20%; Ischemic depression in ST segment during resting or exercise; Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0; Subjects or their guardians agreed to participate in this study. Exclusion Criteria: Previous myocardial infarction or PCI or CABG treatment; A history of heart failure or LVEF < 50%; Severe arrhythmia; Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy; A history of stroke within half a year; Diabetes difficult to control; Refractory hypertension or hypertension accompanied by left ventricular wall thickness > 12 mm; Familial hypercholesterolemia; Takayasu arteritis, Kawasaki disease or coronary artery malformation; Pregnant or nursing, or having the intention to give birth within one year; Hepatic or renal dysfunction; Other diseases which may cause serious risks to patients; Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines; Allergic to contrast agents or blood products; Patients who participated in clinical research of other drugs within 3 months before being selected.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tongxinluo Capsule<br> | Drug: Tongxinluo<br>* Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD<br>|
| Placebo Comparator: Placebo Capsule<br> | Drug: Placebo<br>* Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Coronary Flow Reserve |  | 1 year |
Electrogastrography in Small for Gestational Age Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether small for gestational preterm infants, have delayed or decrease gastric motility compared to appropriate for gestational age preterm infants.

Official Title
-----------------
Electrogastrography in Small for Gestational Age Preterm Infants Compared to Appropriate for Gestational Age Infants

Conditions
-----------------
Premature Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm infants 32-37 weeks' gestation No sepsis or ventilation Feeding orally or with NG tube. Age <48 h to be included Exclusion Criteria: GE reflux Medication that affect gastric motility

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 2 Days

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>Small for gestational age preterm infants | |
| 2<br>Appropriate for gestational preterm infants | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EGG compatible with age |  | day 1 and day 7 after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preterm infants, small for gestational age, electrogastrography
Effect of Erythromycin Before Endoscopy of Patients With Subtotal Gastrectomy (STG), High Risk of Gastric Stasis

Study Overview
=================
Brief Summary
-----------------
Erythromycin has a prokinetic effect through Motilin receptor. It evokes migrating motor complex with longer and stronger contraction. In patients with upper gastrointestinal bleeding, It has been shown that erythromycin could clear the stomach of blood, so visual examination could be improved. Frequent food stasis is encounted when we examine patients with subtotal gastrectomy. It is postulated that erythromycin reduce food stasis and help to improve endoscopy in these cases.

Official Title
-----------------
Effect of Erythromycin Before Endoscopy of Patients With Subtotal Gastrectomy (STG), High Risk of Gastric Stasis : Randomized and Prospective Study

Conditions
-----------------
Subtotal Gastrectomy, Stomach Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who undergone STG (billroth I, billroth II, R-Y STG) within 5 years to treat gastric cancer Stage of T1-2N0M0 Exclusion Criteria: concomitant therapy with astemizole, cisapride, dihydroergotamine, ergotamine, pimozide, or terfenadine, narcotics, alpha-2-adrenergic agonist, TCA, CCB, dopamine agonist, muscarinic cholinergic antagonists, octreotide, exenatide and GLP-1 agonist, phenothiazines chemotherapy Hx. hypersensitivity to erythromycin or any component of the product pregnancy or lactation comobidity : DM, AIDS, neurologic disease(parkinsonism, multiple sclerosis, brainstem stroke or tumor, diabetic or amyloid neuropathy, or primary dysautonomias) scleroderma and other connective tissue disease, recent viral enteritis history recurrence
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: erythromycin<br> | Drug: Erythromycin<br>* 125mg in normal saline single use infusion for 5 min.<br>|
| No Intervention: saline<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of food stasis | ref> Gastric Cancer (2002) 5: 83-89 | when endoscopy is performed. |
Mesh Fixation With a Synthetic Glue in Primary Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Prospective observational study with mesh fixation using FDA approved synthetic glue,glubran 2 and standard mesh fixation with stiches in primary inguinal hernia repair surgery. The investigators aim is to recruit 150 patients for the study. The outcomes The investigators would like to determine are : postoperative pain,recurrences and complication rates such as seromas.

Detailed Description
-----------------
Prospective observational study with mesh fixation using FDA approved synthetic glue,glubran 2 and standard mesh fixation with stiches in primary inguinal hernia repair surgery. The investigators aim is to recruit 150 patients for the study. The outcomes The investigators would like to determine are : postoperative pain,recurrences and complication rates such as seromas.

Official Title
-----------------
Mesh Fixation With a Synthetic Glue in Primary Inguinal Hernia Repair

Conditions
-----------------
Inguinal Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary Inguinal hernia Exclusion Criteria: Recurrent hernia Large inguinoscrotal hernias Bilateral inguinal hernias

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 |
| --- | --- |
| Glubran 2 fixation<br>Mesh fixation with Glubran 2 glue in primary inguinal hernia repair | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain (Evaluation will be conducted through scale and a questionnaire ) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia recurrence (Evaluation will be conducted through a questionnaire and physical examination ) |  | 2 years | 
| Postoperative complications (Evaluation will be conducted through a questionnaire and physical examination ) |  | 2 years |
Efficacy and Safety of a Purified Standardised Bee Venom Preparation

Study Overview
=================
Brief Summary
-----------------
The trial is performed to assess efficacy and safety of a purified standardised bee venom preparation in bee venom allergy

Official Title
-----------------
Immunotherapy of Bee Venom Allergy: Evaluation of a New Purified Bee Venom Preparation in Comparison With Already Published Studies.

Conditions
-----------------
Bee Venom Allergy

Intervention / Treatment
-----------------
* Biological: bee venom


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of bee venom allergy, Positive RAST for bee venom, Positive skin prick test for bee venom Exclusion Criteria: Serious chronic diseases

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: bee venom|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
-----------------
Bee venom allergy, Specific immunotherapy
Tolerability of Sifrol® in Ambulatory Patients Suffering From Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Study to obtain information about the co-operation of the different physician-colleagues in the treatment of patients with Parkinson's disease, both in private practices and clinics and about the primary treatment strategies in the pharmacotherapy of Parkinson's disease and to collect data on the tolerability of Sifrol® in ambulatory patients suffering from Parkinson's disease under routing conditions

Official Title
-----------------
Management of Parkinson's Disease Patients at Their First Visits in a Neurological Practice

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: Pramipexole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Parkinson's disease who present to the specialist neurologist practice for the first time without or with referral and who are planned to receive or either be switched to Sifrol or continue the previously prescribed therapy with Sifrol® can be included in this observational study Exclusion Criteria: Neurologists are asked to consider the Summary of Product Characteristics (SPC) for Sifrol®
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson Disease patients<br> | Drug: Pramipexole<br> <br> * Other names: Sifrol®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment of efficacy by investigator on a 4-point scale |  | after 8 weeks | 
| Change from Baseline in actual Parkinson symptoms |  | Baseline, after 8 weeks | 
| Global Assessment of tolerability by investigator on a 4-point scale |  | after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse drug reactions |  | up to 8 weeks |