linjc16/ctgov huggingface dataset:
Detection of Asymptomatic Atrial Fibrillation in Persons of 65 Year of Age or Older

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation (AF) is the most common cardiac arrhythmia. Although the condition itself is not life-threatening, the complications result in increased morbidity and mortality. AF is often asymptomatic and a considerable number of people suffering from AF are not aware of their condition. Unfortunately, a cerebral infarction is often the first clinical manifestation. The idea to screen subjects opportunistically for Asymptomatic Atrial Fibrillation (AAF) was infeasible until recently. However, with a recently-developed smartphone connected Mobile ECG Device (MED), this seems to be feasible after all. The main objectives are: To examine the feasibility of screening subjects of ≥65 years old for AAF. To validate the smartphone connected MED as an AAF screening instrument for application in transmural care in the Netherlands.

Detailed Description
-----------------
Study design: Prospective validation study.

Official Title
-----------------
Detection of Asymptomatic Atrial Fibrillation in Persons of 65 Year of Age or Older

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥65 years Is willing to give informed consent Exclusion Criteria: Known medical history with Atrial Fibrillation Not mental competent

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Screening with Mobile ECG Device<br>Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device | Other: Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device<br>* Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the mobile ECG device |  | At screening | 
| Specificity of the mobile ECG device |  | At screening | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mobile ECG device, Asymptomatic atrial fibrillation
Kinesio Taping on Chronic Nonspecific Low Back Pain

Study Overview
=================
Brief Summary
-----------------
This study propose analyze the effects of Kinesio Taping® in chronic nonspecific low back pain. All the subjects will be submitted to an evaluation of the painful sensation, functional performance, trunk range of motion and neuromuscular performance at three different times.

Official Title
-----------------
Effects of Kinesio Taping on Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Functional elastic tape tensioned
* Other: Functional elastic tape non-tensioned
* Other: Rigid Tape


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female between 18 and 50 years of age with chronic nonspecific low back pain for more than three months. Exclusion Criteria: Serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis); Nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others); Fibromyalgia Corticosteroid treatment in the previous two weeks; Antiinflammatory treatment in the previous 24 hours; Contraindications to the use of Kinesio Taping (allergy or intolerance); Score of two or less on Visual Analogue Scale of the first day; Pregnancy; Previous Kinesio Tape therapy on lumbar.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>It will not apply any tape. | |
| Experimental: Experimental group 1<br>Apply the KT with tension in the erector spine muscles. | Other: Functional elastic tape tensioned<br>* Application of Kinesio Taping with tension in the erector spine muscles.<br>* Other names: Kinesio Taping with tension;|
| Experimental: Experimental group 2<br>Apply the KT without tension in the erector spine muscles. | Other: Functional elastic tape non-tensioned<br>* Application of Kinesio Taping without tension in the erector spine muscles.<br>* Other names: Kinesio Taping without tension;|
| Placebo Comparator: Placebo group<br>Apply Micropore tape in the erector spine muscles. | Other: Rigid Tape<br>* Application of Micropore tape in the erector spine muscles.<br>* Other names: Micropore Tape;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Painful sensation | Pain sensation measured by pain numerical rating scale | Evaluation of pain sensation three days after the application of the tape. |
Brief Physical Activity Program to Increase Physical Fitness in Elementary School Children

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that the addition of 6 minutes of exercise during the school day would increase physical fitness in elementary school students as demonstrated by longer distances run in 2 minutes and a decrease in heart rate at the end of the exercise.

Detailed Description
-----------------
Intervention group played music for 6 minutes each morning in addition to recess and physical activity classes. Baseline fitness data and after-intervention data were compared.

Official Title
-----------------
The Effects of a Brief Physical Activity Program on Elementary School Students' Physical Fitness

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

Intervention / Treatment
-----------------
* Behavioral: 6 minutes activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All students were invited to participate. Exclusion Criteria: Lack of parental consent
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control School<br>Control School received no intervention. | |
| Experimental: 6 minutes activity<br>Implementation of 6 minutes of physical activity daily into the school day routine. Children can jog in place, do jumping jacks or dance. | Behavioral: 6 minutes activity<br>* Group added 6 minutes of physical activity daily during school day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to After Intervention in 75 Foot Laps Completed in 2 Minutes | Subjects run for 2 minutes around cone separated by 75ft. One lap was one 75 foot length completed. Difference in laps completed from baseline was taken. | Baseline to 12 weeks later | 
| Change From Baseline to After Intervention for After-Exercise Heart Rate | Immediate cool-down, after-exercise heart rate was taken. Difference in heart rate from baseline measurements is reported | Baseline to 12 weeks later |
Malnutrition and Inflammation in Dialysis Patients in Taiwan

Study Overview
=================
Brief Summary
-----------------
According to the reports of the United States Renal Data System (USRDS), there is a 25% annual mortality rate with nearly 50% of all reported maintenance hemodialysis (HD) patient deaths attributed to atherosclerosis-related complications. Although traditional risk factors of cardiovascular disease (CVD) are common in end-stage renal disease (ESRD) patients, they alone may be insufficient to account for their high prevalence of CVD. Recent evidence demonstrated high plasma homocysteine levels have been established as a risk factor of chronic inflammation and atherosclerosis in patients with ESRD. Malnutrition and inflammation was associated with poor quality of life, morbidity and mortality. We, the researchers at National Taiwan University Hospital, hope to establish the best predictive profile of HD patient outcome. Thus, we establish several protocols to complete this work.

Official Title
-----------------
Malnutrition and Inflammation in Taiwan: Prospective Outcome Evaluation Method (MIT-POEM) in Dialysis Patients

Conditions
-----------------
Hemodialysis, Hypercholesterolemia, Malnutrition, Inflammation, Kidney Failure, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: On HD three times a week for more than 3 months (minimizing the confounding effects of residual renal function) Exclusion Criteria: Malignancy; Obvious infections or inflammatory diseases; Preexisting haematological disorders; and, Clinically significant bleeding, transfusion, hospitalization, surgery, or renal transplantation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
Using ctDNA to Detect Minimal Residual Disease After Lung Cancer Resection

Study Overview
=================
Brief Summary
-----------------
ctDNALung-Detect is an investigator-initiated single arm, multi-institution study designed to assess the ctDNA detection rate and its association with Relapse Free Survival (RFS) in operable stage T1-T4 (T3,T4 multifocal) N0M0 non-small cell lung cancer (NSCLC) patients.

Official Title
-----------------
From Liquid Biopsy to Cure: Using ctDNA Detection of Minimal Residual Disease to Identify Patients for Curative Therapy After Lung Cancer Resection (ctDNALung-Detect)

Conditions
-----------------
Non Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years; Ability to provide written informed consent; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; T1-T4 (T3,T4 multifocal) N0M0 NSCLC who are planned for complete surgical resection; Tumour size must be at least 1 cm (unidimensional) and have at least some solid component on imaging; Surgical tumour formalin-fixed, paraffin-embedded (FFPE) specimens for ctDNA studies are required. Exclusion Criteria: Prior radiation, surgery or chemotherapy for the current diagnosis of NSCLC is not permitted. Incomplete surgical resection. Participants who had pre-operative ctDNA samples taken but subsequently do not have a complete surgical resection would not qualify for post-operative ctDNA testing. Concurrent enrolment in a therapeutic study using drug or radiation therapy. Enrolment in observational, diagnostic or studies of novel surgical techniques will be allowed. Concurrent active malignancy or other invasive malignancy within previous 2 years. Non-invasive malignancies (i.e., cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured) are excluded from this definition. Pregnancy.

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 |
| --- | --- | --- |
| Rate of ctDNA Detection | The percentages of pre-operative and post-operative ctDNA detection in patients with T1-T4N0 (T3, T4 multifocal) NSCLC will be estimated together with their Clopper-Pearson exact 95% CIs. | Up to 24 Months | 
| Relapse Free Survival | Relapse free survival (RFS) will be estimated using the Kaplan-Meier method and compared using the logrank test among patients with and without detectable ctDNA pre- or post-operatively. | Up to 36 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival (OS) will be estimated using the Kaplan-Meier method and compared using the log-rank test between patients with and without detectable ctDNA pre- or post-operatively. | Up to 36 Months |
Study of TRM-1(TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of TRM-1 in subjects with relapsed or refractory non-small cell lung cancer.

Official Title
-----------------
A Phase 2, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of TRM-1 (Fully Human Monoclonal Antibody To TRAIL-R1) in Subjects With Relapsed or Refractory Non-Small Cell Lung Cancer

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: TRAIL-R1 mAb (TRM-1;HGS-ETR1)


Participation Criteria
=================
Eligibility Criteria
-----------------
Primary Inclusion Criteria: Relapsed or refractory histologically or cytologically confirmed Stage IIIB, IV, or recurrent NSCLC Previously treated and failed to respond to standard therapy or progressed after standard therapy 18 years of age or older Primary Exclusion Criteria: Received a non-FDA approved investigational agent within the last 4 weeks. Previous cancer therapies (chemotherapy, hormonal therapy, monoclonal antibodies or radiation therapy) within the last 3 weeks, 8 weeks for fully human or humanized monoclonal antibodies Infection requiring antibiotics or hospitalization within the last 2 weeks HIV, Hepatitis-B, Hepatitis-C Pregnant or breast-feeding women Major surgery within the last 4 weeks History of other cancers within the past 5 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TRAIL-R1 mAb (TRM-1;HGS-ETR1)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations

Study Overview
=================
Brief Summary
-----------------
A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.

Official Title
-----------------
A Phase I Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations

Conditions
-----------------
Advanced Malignancies That Harbor IDHR132 Mutations

Intervention / Treatment
-----------------
* Drug: IDH305


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented IDH1R132-mutant tumors ECOG performance status ≤ 2 Exclusion Criteria: Patients who have received prior treatment with a mutant-specific IDH1 inhibitor (with the exception of glioma patients) Medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease. Acute Promyelocytic Leukemia Women who are pregnant or lactating Other protocol-defined Inclusion/Exclusion 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: IDH305<br> | Drug: IDH305<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident rate of dose limiting toxicities (DLTs) | To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE) | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) | To characterize the safety and tolerability of IDH305 | 30 months | 
| Plasma PK parameters (AUC, Cmax, Tmax) | To characterize the PK profile of IDH305 | 30 months | 
| Changes of 2-hydroxyglutarate concentration in patient specimens | To characterize the PD profile of IDH305 | 30 months | 
| Overall response rate (ORR) | To assess any preliminary anti-tumor activity of IDH305 | 30 months | 
| Incidence of serious adverse events (SAE) | To characterize the safety and tolerability of IDH305 | 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IDHR132 mutations, IDH305, IDH, IDH1, AML, Acute Myeloid Leukemia, Leukemia, Myeloid, Acute, MDS, Myelodysplastic Syndrome, Glioma, Oligodendroglioma, Astrocytoma, Glioblastoma, Cholangiocarcinoma, Solid Tumors
Detection of Human Cytomegalovirus in the Saliva

Study Overview
=================
Brief Summary
-----------------
Direct DNA amplification, viral isolation and specific antibody measurement in saliva From children in day care centers (samples collection will take place during a single week) From children coming at the emergency department of our hospital during a three months period. Sample collection will be done by the pediatrician the nurse, or one of the authorized investigators of the study.

Detailed Description
-----------------
Salivary collection kit. Collection of salivary at the internal face of the mooth. 3 swab for DNA research, 1 for antibodies research and 1 for virus isolation by cell growth.

Official Title
-----------------
Detection of Human Cytomegalovirus in the Saliva of 3 Month to 6 Year-Old Children in Day Care Centers : a Pilot Study.

Conditions
-----------------
Cytomegalovirus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parents consent child aged from 3months to 6 years child in day care centers or emergency department Exclusion Criteria: Refuse of participation

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 6 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 |
| --- | --- | --- |
| One week trial of saliva sampling for cytomegalovirus detection in day-care centers. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of chidrens with CMV excretion among those coming at the Emergency department of Limoges teacher Hospital (CHU). Validation of the process from samples collection to interpretation of results |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children in day care centers, cytomegalovirus excretion
Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine whether creatine slows disease progression in subjects with amyotrophic lateral sclerosis (ALS). ALS is a progressive uniformly lethal neurodegenerative disorder for which there is no known cure. Recent genetic and biochemical studies implicate free radical toxicity, glutamate excitotoxicity and mitochondrial dysfunction as possible causes of familial ALS (FALS) and sporadic ALS (SALS). It has been hypothesized that in ALS there may be involvement of oxidative free radical damage and impaired mitochondrial energy metabolism that could in turn lead to excitotoxic cell death. Creatine, an agent that improves mitochondrial function, has been shown to be neuroprotective in animal models of ALS and Huntington's disease. This study is a double-blind, randomized, placebo-controlled trial of the safety and efficacy of creatine in patients with ALS enrolled at sites distributed throughout the United States, including Northeast ALS (NEALS) sites. The study will provide preliminary data on the safety and efficacy of creatine in ALS. If creatine slows disease progression in ALS and is well tolerated, a phase 3 study with survival as the primary outcome measure will be initiated. 114 eligible subjects will be randomized to receive treatment for 6 months of (1) active creatine or (2) placebo. After randomization, subjects will be followed prospectively for 6 months. The primary outcome measure for the study is the change in upper extremity motor function after 6 months of experimental therapy as tested with the Tufts Quantitative Neuromuscular Exam. Strength in eight arm muscles will be measured (bilateral shoulder and elbow flexion and extension). Secondary outcome measures include grip strength, motor unit number estimates (MUNE), the ALS functional rating score-revised (ALSFRS-R), and rate of change of a well established biochemical marker of oxidative damage to DNA (8OH2'dG levels in urine), and the safety and tolerability of creatine.

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Drug: Creatinine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALS FVC >=50% Abnormality in upper and/or lower extremity motor function Not pregnant Disease duration <5 years

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Creatinine|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
-----------------
ALS