linjc16/ctgov huggingface dataset:
Correlation of Particulate Matter and Heme Oxygenase-1 Protein Activity in Asthmatic Children by Induced Sputum Analysis.

Study Overview
=================
Brief Summary
-----------------
Samples of sputum from asthmatic children, between 5-17 years, will be collected during two years of the study period to perform tests Particle Size Distribution (PSD) and Shape Analysis (SA) of the particulate matter in the sputum and a biochemical reaction to evaluate the activity of Heme Oxygenase-1 protein in sputum cell supernatants. Each child will perform Pulmonary Function Testing (PFT) and Induced Sputum (IS) as a routine part of diagnosis of asthma. Parents will be asked to complete a questionnaire including questions on their child's respiratory symptoms in the last 12 months as well as socioeconomic factors. Parents will be asked to give informed written consent for their child's participation in the study.

Official Title
-----------------
Correlation of Particulate Matter and Heme Oxygenase-1 Protein Activity in Asthmatic Children by Induced Sputum Analysis.

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: •All children, between 5-17 years, performing a routine diagnosis of asthma in Tel Aviv Sourasky Medical Center that there parents gave informed written consent for their child's participation in the study. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 17 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Improving Body Image in Middle Schoolers

Study Overview
=================
Brief Summary
-----------------
The focus of this study is the development of a school-based multimedia product for the prevention of body dissatisfaction and unhealthy weight control behaviors in adolescents. The program is being designed for early adolescents, age 12-14, and will include information on maturation, healthy eating and exercise, skill building modules and media literacy awareness.

Conditions
-----------------
Healthy, Body Image

Intervention / Treatment
-----------------
* Behavioral: Education and awareness about body image issues.


Participation Criteria
=================
Eligibility Criteria
-----------------
Adolescents will be recruited from participating schools. Participants must be between the ages of 11-14 years.

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 14 Years

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

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

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 |
| --- |
|Behavioral: Education and awareness about body image issues.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Conditions
-----------------
Diabetic Neuropathies

Intervention / Treatment
-----------------
* Drug: pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females at least 18 years of age, of any ethnic origin Type 1 or 2 diabetes mellitus Pain score greater than or equal to 4 on the 11-point numeric pain rating scale Exclusion Criteria: Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain. Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End of Week 12 responder rates, Brief Pain Inventory - short form, sleep interference scores, Medical Outcome Study - Sleep Scale, Hospital Anxiety and Depression Scale, Patient Global Impression of Change, Neuropathic Pain Inventory Symptom Inventory. |  |  |
Effect E-learning Program About Child Maltreatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the e-learning program about the recognition of child maltreatment is effective in nurses on the A&E department compared to a control group.

Detailed Description
-----------------
Child abuse and neglect represents an international problem with high prevalence and unacceptable levels of morbidity and mortality. Many children are seen each day in the accident and emergency departement of an hospital. Therefore the A&E departement have an important role in the identification of child maltreatment. The lack of an effective teaching program together with the failures in the child protection process has encouraged the development of a clinical-practice-oriented e-learning program on detecting child maltreatment. We will investigate the effect of this e-learning program.

Official Title
-----------------
The Effectiveness of an E-learning Program About Child Maltreatment for Nurses on an A&E Department: a Randomised Controlled Trial

Conditions
-----------------
Child Abuse

Intervention / Treatment
-----------------
* Other: E-learning program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Working at the A&E department of the UMC-Utrecht. Exclusion Criteria: Absent during one of the two measurement periods.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| E-learning program<br>Participants are committed to accomplish the program in approximately 2 hours. Additionally to these mandatory hours, they were able to access the e-learning program at any time and place. | Other: E-learning program<br>* Participants are committed to accomplish the program in approximately 2 hours. Additionally to these mandatory hours, they were able to access the e-learning program at any time and place.<br>* Other names: Web-based learning;|
| control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical behaviour on the A&E department, self-efficacy of the nurse in the detection of child abuse and assessment of the individual performance on screening child abuse. |  | 2-3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
child abuse and neglect, child maltreatment, non accidental injury, training, educational program
Estimated Echocardiographic Pulmonary Capillary Wedge Pressure in Heart Failure

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to verify the effects of moderate versus low sodium intake on pulmonary capillary wedge pressure (PCWP), determined by Doppler echocardiography and tissue Doppler imaging in patients suffering from compensated heart failure.

Detailed Description
-----------------
the study outcome is hospital readmission and mortality after 12 months of two different sodium diet.

Official Title
-----------------
Moderate Versus Low Sodium Diet Intake Effects on Estimated Echocardiographic Pulmonary Capillary Wedge Pressure During 12 Months of Follow up in Compensated Heart Failure Patients.

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Dietary Supplement: normal sodium diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: compensated HF patients Exclusion Criteria: decompensated HF patients

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
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: normal sodium diet (120 mmol/die)<br>active comparator: low sodium diet (80 mmol/die) | Dietary Supplement: normal sodium diet<br>* normal sodium diet (120 mmol/daily) for 1 year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of hospital readmitted patients | every six months we measure the PCWP by echocardiography | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of death |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sodium ,diuretics, PCWP
Long Term Follow-Up Study of Immuncell-LC Group and Non-Treatment Group in Hepatocellular Carcinoma Patients.

Study Overview
=================
Brief Summary
-----------------
To observation that long term follow-up study of 'Immuncell-LC groups' and 'Non-treatment groups' in patient undergo curative resection (PEIT, RFA or Operation) for hepatocellular carcinoma in Korea

Official Title
-----------------
Long Term Study of 'Immuncell-LC Groups' and 'Non-treatment Groups' in Patient Undergo Curative Resection (PEIT, Radiofrequency Ablation [RFA] or Operation) for Hepatocellular Carcinoma in Korea

Conditions
-----------------
Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior to the test, patient is fully explained about the purpose/ contents and characteristics of the testing medication, and the patient him(her)self, the guardian or the legal representative signed on written consent. Patients of participated in the(ClinicalTrials.gov Identifier:NCT00699816)clinical trial. Exclusion Criteria: Patient who is incongruent to this clinical trial by sub-investigator's opinion.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Non-treatment Group<br>Patients who were in non-treatment group in phase 3 clinical trial IIC-I01(NCT00699816). | |
| Immuncell-LC Group<br>Patients who were in Immuncell-LC group in phase 3 clinical trial IIC-I01(NCT00699816). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate recurrence-free survival | Radiological test should be operated by dynamic CT(using 64 cut), dynamic MRI or by angiography. | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the response rate to evaluate overall survival and cause specific survival and changes of Alpha feto protein (AFP) figures from baseline to the last observation date. |  | up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immuncell-LC, Hepatocellular carcinoma
Effects of Green Coffee Extract Supplementation on Leptin, Ghrelin, Adiponectin,Anthropometric Measurements, Lipid Profile in Breast Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
To study the effects of green coffee supplement on leptin, adiponectin, ghrelin, anthropometric measurements, lipid profile in breast cancer survivors.50 breast cancer survivors who their treatment is over and referred to follow breast cancer clinic with will be randomly allocated to receive placebos or 2 capsules green coffe for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, leptin, adiponectin, ghrelin, anthropometric measurements, lipid profile will be assessed and compared between groups.

Official Title
-----------------
the Evaluation of Green Coffee Extract Supplementation on Leptin, Ghrelin, Adiponectin,Anthropometric Measurements, Lipid Profile in Breast Cancer Survivors

Conditions
-----------------
Breast Cancer Survivors

Intervention / Treatment
-----------------
* Dietary Supplement: green coffee
* Other: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 18 to 70 years Body Mass Index (BMI) between 25-40 treatment is over Exclusion Criteria: -Taking any kind of supplement for weight reduction pregnancy or lactation Professional athletes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: green coffe<br>green coffe 2 capsuls of green coffe | Dietary Supplement: green coffee<br>* 2 capsuls<br>|
| Placebo Comparator: control<br>2 capsuls of placebo | Other: control<br>* 2 capsuls<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gherlin | assed by elisa | 12 weeks | 
| Adiponectin | assed by elisa | 12 weeks | 
| Leptin | assed by elisa | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index | The body mass index (BMI) or Quetelet index is a value derived from the mass (weight) | 12 weeks |
Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Primary Axillary Hyperhidrosis

Study Overview
=================
Brief Summary
-----------------
This study is intented to evaluate the efficacy and safety of MEDITOXIN compared to placebo in treatment of primary axillary hyperhidrosis.

Official Title
-----------------
A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Primary Axillary Hyperhidrosis

Conditions
-----------------
Hyperhidrosis Primary Focal Axilla

Intervention / Treatment
-----------------
* Drug: Meditoxin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients aged from 20 to 65, with persistent bilateral primary axillary hyperhidrosis Exclusion Criteria: those who have secondary hyperhidrosis those who have systemic neuromuscular junction disorders women who are pregnant or lactating

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: botulinum toxin type A<br> | Drug: Meditoxin<br>* 50U of MEDITOXIN is injected intradermally to each axilla<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* normal saline is injected intradermally to each axilla<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of treatment responder | subjects who reported at least a 2-point improvement from baseline HDSS score | 4 weeks after the injection |
Expanded Access Program With Nivolumab Therapy for Treatment of Advanced/Metastatic SqNSCLC or Non-SqNSCLC After One Prior Systemic Regimen

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide treatment with nivolumab, a fully human monoclonal antibody, to subjects who have relapsed after treatment with a minimum of 1 prior systemic treatment for advanced or metastatic squamous (Sq) or non-squamous (non-Sq) non-small cell lung cancer (NSCLC) , Stage IIIB/IV and whose physicians believe that nivolumab treatment is appropriate.

Official Title
-----------------
Expanded Access Program With Nivolumab Monotherapy in Subjects With Advanced or Metastatic Squamous (Sq) or Non-Squamous (Non-Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimens for the Treatment of Stage IIIb/IV SqNSCLC

Conditions
-----------------
Squamous Non-Small Cell Lung Cancer, Non-squamous Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Nivolumab


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Sq or Non-Sq NSCLC, Stage IIIb/IV (histologically or cytologically confirmed) Relapsed after 1 prior platinum-based systemic treatment Eastern Cooperative Oncology Group (ECOG) Performance Status < 2 CNS metastasis must be treated and returned to baseline at least 2 weeks before first dose of nivolumab and off steroids or using stable or decreasing dose of < 10 mg prednisone or equivalent Prior chemotherapy, Tyrosine Kinase Inhibitor (TKI) therapy or Immunotherapy (tumor vaccine, cytokine or growth factor to control cancer) must be completed at least 2 weeks before first nivolumab dose Exclusion Criteria: CNS metastases (untreated and/or symptomatic) Carcinomatous meningitis ECOG Performance status > 3 Corticosteroids > 10 mg prednisolone/day (or equivalent) Prior treatment with anti-PD-1, anti-PD-L-1, anti-PDL2, anti-CT137 or anti-CTLA antibody, including ipilimumab or any other drugs specifically targeting T cell costimulation or checkpoint pathways

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nivolumab|Specified dose on specified days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pulmonary Vein Ablation of Atrial Fibrillation Using Magnetic Navigation: Single Ring Versus Circumferential Techniques

Study Overview
=================
Brief Summary
-----------------
The single-ring ablation method aims for isolation of the posterior LA wall including the pulmonary veins. If avoiding ablation on the posterior LA wall esophageal injury is unlikely. Aim of this prospective study was to evaluate the safety and efficacy of an RMN-guided single-ring ablation method as compared to standard RMN-guided circumferential PVA.

Official Title
-----------------
Pulmonary Vein Ablation With Magnetic Navigation in Patients With Therapy-refractory Symptomatic Atrial Fibrillation: Comparison of Single Ring and Circumferential Ablation Techniques

Conditions
-----------------
Pulmonary Vein Isolation, Ablation Time, Procedure Time, Freedom Form Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Circumferential pulmonary vein ablation
* Procedure: single ring pulmonary vein ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: drug refractory AF patients undergoing PVA Exclusion Criteria: drug refractory AF patients undergoing repeat PVA

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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 |
| --- | --- |
| Other: Circumferential ablation<br> | Procedure: Circumferential pulmonary vein ablation<br>* Circumferential pulmonary vein ablation<br>|
| Experimental: Single ring ablation<br> | Procedure: single ring pulmonary vein ablation<br>* single ring pulmonary vein ablation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute procedural success | number of PVs isolated at the end of the ablation procedure | After the end of the ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term procedural success | long-term freedom from any AT/AF episodes | 12 months |