linjc16/ctgov huggingface dataset:
Injury Prevention Among Conscripts

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to study the effect of neuromuscular training program and regular safety counselling on the risk of musculoskeletal injuries in adolescent conscripts. 800 voluntary participants are recruited from the four army companies in western Finland during the years 2007 and 2008.

Official Title
-----------------
Prevention of Musculoskeletal Injuries in Finnish Conscripts. A Cluster Randomized Controlled Trial.

Conditions
-----------------
Back Problems and Other Musculoskeletal Injuries

Intervention / Treatment
-----------------
* Other: physical training and counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy conscripts who gave informed consent for participation Exclusion Criteria: disease or injury preventing physical training

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Active treatment: physical training and counselling | Other: physical training and counselling<br>* Neuromuscular training program 3 times per week 30 minutes per session and counselling on back problems and other musculosceletal injuries<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Musculoskeletal injuries |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of low back pain, Physical fitness |  | 1,2,6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, physical fitness, injury, prevention, conscripts
Anxiety and Depression in COPD; Prevalence, Detection and Prognosis

Study Overview
=================
Brief Summary
-----------------
The current cohort study of 300 stable COPD patients aims to assess the following topics: The prevalence of anxiety and depressive disorders in patients with COPD The screening properties of Hospital Anxiety and Depression Scale in patients with COPD The prognostic influence by anxiety or depressive symptoms and anxiety or depressive disorder. whether characterization of 1) affective aspects of dyspnea symptoms or 2) persistent styles of thinking (worry or rumination) and metacognitions that drive these may improve the current recommendation of screening for anxiety and depression in COPD in relation to its clinical relevance on functional status and three year outcome

Official Title
-----------------
Anxiety and Depression in COPD; Prevalence, Detection and Prognosis

Conditions
-----------------
COPD, Anxiety Disorders, Depressive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant in in-hospital pulmonary rehabilitation at LHL-hospital Gardermoen Diagnosis of COPD Exclusion Criteria: Acute exacerbated phase of COPD

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 |
| --- | --- | --- |
| COPD exacerbation rate | The number of moderate or severe exacerbations | 3 years | 
| Mortality rate | The number of deaths | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Health-related Quality of Life With RAND-36 | The total score and subscale scores on RAND 36 | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metacognitions, Hospital Anxiety and Depression Scale
Synthetic Human Secretin in Children With Autism and Gastrointestinal Dysfunction

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the effect of multiple doses of secretin on autism.

Official Title
-----------------
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Efficacy, Safety and Tolerability of RG1068 (Synthetic Human Secretin) in Children With Autism and Gastrointestinal Dysfunction

Conditions
-----------------
Autism

Intervention / Treatment
-----------------
* Drug: RG1068 (Synthetic Human Secretin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Autism Gastrointestinal dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 32 Months
Maximum Age: 59 Months

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: RG1068 (Synthetic Human Secretin)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ascertainment of Saliva or Blood Samples For Genetic Epidemiology Studies of Cancer and Aging

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to help us learn more about the roles of genes in cancers. Genes are short pieces of DNA which determine the inherited characteristics that distinguish one individual from another. This study will look at how some genes might raise or lower the chance some people may develop cancer. The sample collection will help generate the materials needed for this study.

Detailed Description
-----------------
This is a protocol to obtain saliva or blood samples from non-cancer affected volunteers aged 60 years or older, without a history of cancer other than non-melanoma skin cancer. These samples will be used in a genomic approach to elucidate novel pathways of cancer predisposition.

Official Title
-----------------
Ascertainment of Saliva or Blood Samples For Genetic Epidemiology Studies of Cancer and Aging

Conditions
-----------------
Non-cancer Affected Volunteers

Intervention / Treatment
-----------------
* Other: Saliva or Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible subjects must be non-cancer affected volunteers of either gender who are 60 years of age or older at the time of saliva/blood donation. Subjects will self-identify religion and country of origin of grandparents. Volunteers will have (by self report) no history of cancer other than nonmelanoma skin cancer. It is recognized that there may be some errors in self report, however, the literature reports a very low error rate for self reported disease reporting for cancer as assessed by interview. Exclusion Criteria: Subjects with mental impairment will be excluded from this study.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Saliva or Blood samples|Extracting sample of saliva or blood only once.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| obtain saliva or blood from non-cancer volunteers, 60 years or older to carry out anonymous genetic epidemiology studies related to resistance to cancer in elderly. |  | conclusion of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| samples perform high density genomic scans & candid gene studies carriers specif BRCA found mutat who haven't been affect by breast cancer & old than 60 find genetic cofactor may modify a predispo breast ca confer by germline mutation in BRCA1 & BRCA2. |  | conclusion of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-cancer affected volunteers, aged 60 years or older
A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Study Overview
=================
Brief Summary
-----------------
This study is designed to explore the safety and tolerability of RD14-01 for patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma. And to evaluate the efficacy and pharmacokinetics of RD14-01 in patients.

Official Title
-----------------
A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Conditions
-----------------
Mantle Cell Lymphoma, Diffuse Large B-cell Lymphoma, Follicular Lymphoma

Intervention / Treatment
-----------------
* Drug: RD14-01 cell infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 to 75 years. Diagnosis of r/r MCL, DLBCL, or FL (Grade 1, 2 and 3a). ECOG: 0-1. Life expectancy greater than 3 months. Cardiac left ventricle ejection fraction ≥50%. Informed consent explained to, understood by and signed by the patient/guardian. Patient/guardian is given a copy of informed consent. Exclusion Criteria: Pregnant or lactating. Hepatitis B surface antigen (HBsAg) or hepatitis B e-antigen (HBeAg) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody positive; cytomegalovirus (CMV) DNA positive; Epstein-Barr virus (EBV) DNA positive. Central nervous system (CNS) metastases. Participated in other clinical studies within 4 weeks prior to screening. History of alcoholism, drug abuse or mental illness. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RD14-01 cell infusion<br>Infused i.v. in a single dose | Drug: RD14-01 cell infusion<br>* Autologous CAR T cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity | DLT | Up to 2 years | 
| Maximum tolerable dose | MTD | Up to 2 years |
A LAparoscopic and TransAnal Total Mesorectal Excision (TME) for Rectal Cancer Trial

Study Overview
=================
Brief Summary
-----------------
All patients planned for an anterior resection due to rectal cancer with a total mesorectal excision are included. This is a feasibility study, thus no randomization will be performed. Primary endpoint is clinical and pathologic examination of the specimen. Secondary end-points include clinical variables such as conversion rate, re-admission and/or re-operation due to any complication and health economy analyses.

Detailed Description
-----------------
The design is comparative and prospective, we will compare specimens from patients operated at our institution during the last year with standard open or laparoscopic approach with patients operated with the new technique. Patients in the control arm will be patients operated prior to the commencement of the new technique or patients not eligible or possible to include in the study. It is possible to obtain a macroscopically and microscopically adequate specimen after a combined approach with laparoscopic and transanal TME compared to open or laparoscopic conventional TME.

Official Title
-----------------
A LAparoscopic and TransAnal Total Mesorectal Excision (TME for Rectal Cancer Trial

Conditions
-----------------
Colorectal Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presenting with a rectal cancer possible to operate with a total mesorectal excision and an anastomosis according to the local multidisciplinary conference possible to operate with laparoscopic technique possible to operate in regard to concomitant disease giving informed consent to participate Exclusion Criteria: -Participation in other trials in conflict with the protocol and end-points the LATA-trial
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopic total mesorectal excision<br>Patients operated with laparoscopic total mesorectal surgery for rectal cancer | |
| transanal total mesorectal excision<br>Patients operated with a combined transanal and laparosocopic total mesorectal surgery for rectal cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of specimens with grade I specimen according to Quirke | Comparison with control group | 4 weeks postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion rate |  | day of surgery | 
| Re-admission |  | 30 days | 
| Postoperative complications scored according to Clavien-Dindo within the first 12 months |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rectal Cancer, Surgery, Laparoscopy
Gut Permeability and Stress

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyse gut permeability and stress.

Detailed Description
-----------------
Healthy male volunteers (aged 19-35 years) participate in Trier social stress test while saliva and blood samples are withdrawn. Saliva will be used for analysis of cortisol and blood will be used for analysis of various biomarkers.

Official Title
-----------------
Gut Permeability in Volunteers Participating in a Stress Test

Conditions
-----------------
Stress

Intervention / Treatment
-----------------
* Other: Trier social stress test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man, 19-35 years old Healthy Exclusion Criteria: Psychological disorders Use of antibiotics or other drugs

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| stressed<br>stressed volunteers perform Trier social stress test | Other: Trier social stress test<br>* Volunteers perform Trier social stress test<br>|
| non-stressed<br>non-stressed volunteers perform Trier social stress test | Other: Trier social stress test<br>* Volunteers perform Trier social stress test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gut permeability (marker measured in plasma/serum) in healthy young men participating in Trier social stress test |  | Volunteers will be followed by one hour after Trier social stress test |
Pattern of Non Valvular Atrial Fibrillation in Acute Ischemic Stroke Patients at Assiut University Hospitals

Study Overview
=================
Brief Summary
-----------------
Pattern of non valvular Atrial fibrillation in acute ischemic stroke patients at Assiut University Hospitals.

Detailed Description
-----------------
Percentage of patients with AF admitted with acute cerebrovascular stroke at Assuit University and correlation between AF and severity of stroke at admission and discharge.

Official Title
-----------------
Pattern of Non Valvular Atrial Fibrillation in Acute Ischemic Stroke Patients at Assiut University Hospitals

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

Intervention / Treatment
-----------------
* Device: echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presented with acute cerebrovascular stroke aged more than 18 years old. Exclusion Criteria: Patients below 18 years old. Patient admitted with cerebral hemohrrage. Patients with significant valvular heart disease.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ischemic stroke patients<br>all patient admitted with acute ischemic stroke either their ECG was AF or sinus rythm | Device: echocardiography<br>* echocardiography for left atrial diameter, size ,Ejection Fraction Holter for detection of paroxusmal AF<br>* Other names: holter;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with AF admitted with acute cerebrovascular stroke at Assuit University. | study the Percentage of patients with AF admitted with acute cerebrovascular stroke at Assuit University whatever those patients have manifest atrial fibrillation or go into attacks of paroxysmal atrial fibrillation by the use of echocardiography for measurement of left atrial diameter and size and also by the use of Holter to identify any any attacks of paroxysmal atrial fibrillation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between AF and severity of stroke at admission and discharge. | relation between presence of AF and severity of stroke by the use of NIH Stroke Score and MRS score at time of admission and discharge. | 1 year | 
| The role of anti coagulants in decreasing risk of ischemic cerebrovascular stroke in patients who are known to have Atrial Fibrillation and have been already anticoagulated | if the anticoagulant intake decrease stroke severity in patients who are already taking anticoagulants by the use of NIH Stroke Score and MRS score at time of admission and discharge | 1 year |
Microbial and Human Determinants of the Onset of IBD Flares

Study Overview
=================
Brief Summary
-----------------
This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata. This study is direct to participant and will not utilize clinical sites.

Detailed Description
-----------------
This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata. This study will last approximately 3 years and will recruit up to 1000 Crohn's Disease participants and up to 1000 Ulcerative Colitis participants that will participant in the study for approximately 12 months. Participants will be sent at home sample collection kits and a study survey each month. If the survey responses indicate a participant is in a flare, they will be sent a sample collection kit and survey on a weekly basis until the flare is over and the monthly schedule resumes. The objective of the data analysis is to identify microbial functions that are predictive of the onset of a flare.

Official Title
-----------------
Microbial and Human Determinants of the Onset of IBD Flares on a National Scale - an Observational Study

Conditions
-----------------
Ulcerative Colitis, Crohn Disease, Irritable Bowel, Crohns Disease Aggravated, Crohn Disease in Remission

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Able to provide written informed consent prior to screening Established diagnosis of small bowel or colonic Crohn's Disease (CD) or Ulcerative Colitis (UC) Exclusion Criteria: Pregnant or breastfeeding Use of antibiotics within the last 3 months Bowel surgery in the past 3 months or planned bowel surgery during the 12-month study period

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 |
| --- | --- |
| Ulcerative Colitis (UC)<br>Individuals with an ICD-10 diagnosis of Ulcerative Colitis. | |
| Crohn's Disease (CD)<br>Individuals with an ICD-10 diagnosis of Crohn's Disease. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Names of species | Species present in samples taken in IBD and IBD flare onset states. | 3 years | 
| Number of species | Number of each species present in sample taken in IBD and IBD flare onset states. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBD, flare, UC, CD, HBI, SCCAI, stool, diarrhea, abdominal pain, inflammation, colon, rectum