linjc16/ctgov huggingface dataset:
Effects of a 4-week Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) Program on Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to investigate the effectiveness of Acu-TENS (transcutaneous electrical nerve stimulation applied on acupoints) on lung functions and quality of life and to explore the associated underlying mechanisms in subjects with COPD.

Official Title
-----------------
Effects of a 4-week Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) Program on Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Device: Acu-TENS (Transcutaneous electrical nerve stimulation)
* Device: Acu-TENS (Transcutaneous electrical nerve stimulation)
* Device: Acu-TENS (Transcutaneous electrical nerve stimulation)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis with COPD Exclusion Criteria: allergic to gel unable to perform spirometry unable to communicate no history of infection or exacerbation of respiratory symptoms

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Device: Acu-TENS (Transcutaneous electrical nerve stimulation)<br>* Transcutaneous electrical nerve stimulation applied onto acupuncture point<br>|
| Placebo Comparator: Group 2<br> | Device: Acu-TENS (Transcutaneous electrical nerve stimulation)<br>* Similar to Group 1 but without electrical stimulation<br>|
| Sham Comparator: Group 3<br> | Device: Acu-TENS (Transcutaneous electrical nerve stimulation)<br>* Similar to Group 1 but applied onto non acupuncture point<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) |  | measured before and after the 4-week program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| beta endorphin, St George Respiratory Questionnaire (SGRQ) |  | measured before and after the 4-week program | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, FEV1, beta endorphin, SGRQ, Acu-TENS
Cryotherapy -BEATS-RF Ablation Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether cryotherapy is effective in the treatment of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in patients who have not responded to radiofrequency ablation (RFA).

Official Title
-----------------
CryoSpray Ablation for Barrett's Esophagus After Treatment Failure With Serial RadioFrequency Ablation

Conditions
-----------------
Barrett's Esophagus With Persistent Dysplasia or, Early Esophageal Adenocarcinoma Post Radio Frequency Ablation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old Able to provide informed consent Patients with unifocal or multifocal BE with HGD or IMCA who have failed at least 2 serial RFA therapy. Patients who refused esophagectomy or deemed inoperable or whose BE dysplasia is not amenable to endoscopic mucosal resection (EMR) treatment alone due to: (1) extensive multifocal lesions (2) severe coagulopathy or any medical condition deemed high risk for EMR (3) patient refuses EMR Patients with a nodular BE lesions may undergo clinically-indicated EMR and still be eligible for enrollment as long as they have BE-HGD lesion/s that are still candidate for ablative treatment Exclusion Criteria: Age younger than 18 years old Life expectancy less than 12 months Pregnancy Presence of esophageal varices Esophageal stricture precluding passage of an endoscope and suction tubing Any procedure that has impeded normal gastric emptying or limited gastric volume distention, including but not limited to gastric bypass, stomach stapling, gastrojejunostomy or any disease state has significantly reduced the elasticity in the GI tract (e.g. Marfan's syndrome, Scleroderma or any Connective Tissue Disease) Esophageal cancer (T2 and above)

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 |
| --- | --- |
| failure to respond to RF ablation<br>patients undergoing endoscopic RF ablation therapy with persistent BE with HGD or IMCA despite 2 or more serial RF ablation treatment sessions | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response | To assess efficacy of achieving elimination of dysplasia in patients with RFA-refractory BE with HGD or IMCA | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictors of response | To identify potential predictors of CE-D and CE-IM in patients requiring rescue CSA treatment after failed RFA therapy | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrett's esophagus, Early esophageal adenocarcinoma, Radio Frequency Ablation, Cryotherapy
Leipzig Childhood Obesity Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify polymorphisms that make children and adolescents more prone to obesity and metabolic dysfunction, as well as to identify biomarkers that are linked to causes and consequences of obesity.

Detailed Description
-----------------
In order to identify single nucleotide polymorphisms blood and serum samples during oral glucose tolerance testing are routinely obtained from pediatric patients visiting the adiposity outpatient clinic.

Official Title
-----------------
Extended Geno- and Phenotyping of Overweight and Obese Children and Adolescents

Conditions
-----------------
Childhood Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all pediatric patients seen in the adiposity outpatient clinic informed patient consent Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with overweight and obesity<br>Overweight and obese children and adolescents visiting the adiposity outpatient clinic. | |
| adults<br>follow up of patients into adulthood | |
| control group<br>matched control group with children, adolescents and aduts without obesity | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene-dependent association with phenotypical traits in overweight and obese children |  | 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Single nucleotide polymorphisms, Obesity, Insulin resistance, Metabolic syndrome, Oral glucose tolerance test
Azacitidine and Homoharringtonine in JMML

Study Overview
=================
Brief Summary
-----------------
Juvenile myelomonocytic leukemia (JMML) has a poor prognosis in general, with hematopoietic stem cell transplant (HSCT) remaining the standard of care for cure. Azacitidine and homoharringtonine, which exhibited a anticancer mechanism and has been widely used in patients with relapse/refractory acute myeloid leukemia (AML). However, the efficacy of these agents has not been elucidated in children with JMML. The primary objective is to assess the treatment effect on response rate in this subject population.

Official Title
-----------------
Efficacy of Concomitant Use of Azacitidine and Homoharringtonine in Children With Juvenile Myelomonocytic Leukemia

Conditions
-----------------
JMML

Intervention / Treatment
-----------------
* Drug: Azacitidine and homoharringtonine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed JMML, with PB and BM confirming diagnosis prior to informed consent signature, with one of the following: somatic mutation in PTPN11 somatic mutation in KRAS somatic mutation in NRAS and HbF % > 5x normal value for age clinical diagnosis of neurofibromatosis Type 1. Exclusion Criteria: 1. Any condition that would prevent the subject from participating in the study. 2. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if participated in the study. 3. Any condition that confounds the ability to interpret data from the study.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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: Intervention group<br> | Drug: Azacitidine and homoharringtonine<br>* Concommitant use of azacitidine and homoharringtonine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Juvenile Myelomonocytic Leukemia (JMML) response rate at end of 4 Months | Defined as proportion of patients with sustained clinical complete remission [cCR] or clinical partial remission [cPR] according to the International JMML response criteria in Niemeyer 2014 at 3 months (28 days cycles). Response must be sustained for at least 4 weeks either in the 4-week period preceding or succeeding 3 months (ie, sustained over the period minimum 2 months to end of 3 months, or end of 3 months to end of 4 months). | Up to 4 Months |
Metabolic Changes in Patients With Chronic Cardiopulmonary Disease

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate prevalence of sarcopenia and cachexia in patients with chronic cardiopulmonary disease. The investigators will also investigate metabolic disorders like glucose metabolism, presence of metabolic syndrome, body composition and histological changes in skeletal muscle and body fat. Finally, patients will be followed for clinical endpoints.

Official Title
-----------------
Metabolic and Histological Changes in Skeletal Muscle and Fat Tissue in Patients With Chronic Cardiopulmonary Disease

Conditions
-----------------
Heart Failure, Chronic Obstructive Pulmonary Disease, Malignancy, Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of chronic disease (Heart failure, COPD, malignancy, CKD) or no diagnosis (controls) Exclusion Criteria: refuse to participate

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart failure<br> | |
| Chronic obstructive pulmonary disease<br> | |
| Chronic kidney disease<br> | |
| Malignancy<br> | |
| Controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance (HOMA-IR) | HOMA-IR as calculated by formula using insulin and blood glucose | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength (Handgrip test) | Handgrip test | Baseline | 
| Change in exercise capacity (6 minute walk test) | Determined by incremental exercise test, 6 minute walk test | baseline and after 5 weeks | 
| Neurohormonal activation (NT-proBNP concentration) | NT-proBNP concentration | Baseline | 
| Change in apoptosis in skeletal muscle (number of apoptotic cells per square mm) | histological evaluation: number of apoptotic cells per square mm | Baseline and after 5 weeks | 
| Change in insulin resistance (HOMA-IR) | HOMA-IR as calculated by formula using insulin and blood glucose | Baseline and after 5 weeks |
L1 M1 of LDCT for Low Muscle Mass Measurement

Study Overview
=================
Brief Summary
-----------------
The first lumbar spine muscle index (L1 MI) on computed tomography (CT) obtained by measuring muscle surface at the first lumbar vertebrae (L1) level is an indicator of total skeletal mass in specific populations. Nevertheless, the utility of L1 MI derived from low dose chest CT (LDCT) in health assessments and relevant cutoff points are unclear.

Official Title
-----------------
Evaluation of Low Muscle Mass by Muscle Surface Index of First Lumbar Vertebrae Using Low Dose Computed Tomography

Conditions
-----------------
Sarcopenia

Intervention / Treatment
-----------------
* Diagnostic Test: low dose chest CT(LDCT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults older than 20 years who received LDCT in routine health assessments from January to December 2017 were enrolled at a tertiary care hospital (Far Eastern Memorial Hospital, New Taipei City, Taiwan). Exclusion Criteria: nil

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: low dose chest CT(LDCT)|cross sectioned muscle area of the 1st vertebrae level obtained by LDCT|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cross sectional muscle area of the 1st vertebrae level | Cross sectional muscle area of the 1st vertebrae level by LDCT | 52 weeks |
A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Subjects With Pyoderma Gangrenosum

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the long-term safety of gevokizumab in treating active PG ulcers

Official Title
-----------------
A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Patients With Pyoderma Gangrenosum

Conditions
-----------------
Pyoderma Gangrenosum

Intervention / Treatment
-----------------
* Drug: gevokizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals who participated in a previous study of gevokizumab in PG A clinical diagnosis of classic pyoderma gangrenosum Contraceptive measures adequate to prevent pregnancy during the study Exclusion Criteria: Clinical evidence of acutely infected pyoderma gangrenosum History of allergic or anaphylactic reactions to monoclonal antibodies History of recurrent or chronic systemic infections Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding Other protocol-defined inclusion/exclusion criteria may apply

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: gevokizumab<br>Solution for subcutaneous injection | Drug: gevokizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of treatment-emergent adverse events; |  | Up to 2 years | 
| Changes from baseline vital signs, physical examination results, and laboratory test results |  | Up to 2 years | 
| Changes from baseline concomitant medications use |  | Up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pyoderma Gangrenosum, Classic Pyoderma Gangrenosum
Events Before Death

Study Overview
=================
Brief Summary
-----------------
Previous studies of the patients treated in RRI clinics suggest that hemodialysis patients undergo a certain consistent predictable pattern at the initiation of dialysis and before death. This pattern can be described as a group of patterns of patients' biological markers over a few months after starting dialysis and several months prior to death. Additional patterns can be observed that occur with changes in seasons or time of day. The aim of this study is to compare these patterns in patients treated in FMC-Asia, FMC-Europe, FMC-South America, and RRI-US populations. Noting that patterns in patient parameters are similar across continents, climates, and geographic variations only further accentuates the importance in the models that can predict patients' survival and provide an opportunity for timely intervention.

Official Title
-----------------
International Comparison of Evolution of Clinical and Laboratory Parameters in Chronic Hemodialysis Patients

Conditions
-----------------
End Stage Renal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodialysis vintage 2+ months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 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 |
| --- | --- |
| Hemodialysis patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Date of death | The main purpose of the study is developing an alert system that will help dialysis providers recognize patients who are at increased risk of death (or hospitalization). This alert system will be developed and can be utilized in patients treated all over the world. | 10 years and 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalizations |  | January 2000 - May 2010 |
Investigator Initiated Study - Asenapine Early Psychosis

Study Overview
=================
Brief Summary
-----------------
We propose a use of a unique facility, the databank at the CNDV, to examine the impact of switching subjects to asenapine in an open-label naturalistic setting. This offers the following advantages: i) providing data on a particularly important population, i.e., subjects who are at the inception of treatment for a psychotic disorder and who are likely to remain on a given drug on a long-term basis; ii) its inclusion in a rich clinical setting, with a clinical team dedicated to provide innovative interventions; iii) its naturalistic design, that will allow to obtain data that will be applicable to real-life clinical settings; indeed, subjects who will be switched to asenapine within the current project are those we would switch to this drug in our daily practice.

Official Title
-----------------
An Open-label Switch Study to Asenapine in the Early Stage of Psychosis

Conditions
-----------------
Schizophrenia and Disorders With Psychotic Features, Disorders

Intervention / Treatment
-----------------
* Drug: Asenapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meeting DSM-IV criteria for schizophrenia (SZ) or related SZ spectrum psychotic disorders having provided a consent to include data on our databank,and being able to provide informed consent willingness to participate to the assessments being over 18 years of age being in a clinical situation that warrants switch to asenapine Exclusion Criteria: suffering from a primary drug-induced psychosis being at significant risk for suicide or assault unstable medical condition persistence of psychotic symptoms despite adequate treatment to an extent that clozapine would be required being treated with antipsychotic for 5 years or more having contraindications(allergy to asenapine) being pregnant or lactating

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 |
| --- | --- |
| Other: Asenapine<br>Open label switch to asenapine: asenapine will be introduced at the target dose (5 mg bid) | Drug: Asenapine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of switching to asenapine |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictors of successful switch to asenapine |  | 3 months |