linjc16/ctgov huggingface dataset:
International Programs Collaborative Studies Coordinating Center

Study Overview
=================
Brief Summary
-----------------
To continue the work of the Collaborative Studies Coordinating Center (CSCC) on international studies in cardiopulmonary disease epidemiology. The work was being performed under bilateral agreements that the NHLBI had entered into with Russia, The People's Republic of China and Pakistan. The contract provided nutritional, epidemiologic and biostatistical services in support of these studies.

Detailed Description
-----------------
BACKGROUND: Computer processing, biostatistical, and epidemiological services at the Collaborative Studies Coordinating Center (CSCC) had been funded previously as part of the NHLBI Lipid Research Clinics (LRC) contracts. In FY 1990, contract N01HV08112 was awarded separately from the LRC for the first time and provided services for collaborative studies carried out under NHLBI international bilateral agreements with the USSR, Poland, and the People's Republic of China. The assistance has provided important contributions to large-scale, international epidemiological studies resulting from bilateral agreements between the United States and other countries. The results of these efforts have provided insights into different disease patterns and trends throughout the world. DESIGN NARRATIVE: The CSCC coordinated data collection and data file transfer, coordinated scientific meetings, visited the collaborating countries, hosted collaborative scientists, and directed data analysis, combining data from all countries.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Diagnosis of Variceal Bleeding and Its Control in Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to determine the independent predictors of variceal bleeding and control of bleeding in cirrhosis as no scientific assessment have been perfomed until now

Official Title
-----------------
Diagnosis of Variceal Bleeding and Its Control in Cirrhosis

Conditions
-----------------
Cirrhosis

Intervention / Treatment
-----------------
* Behavioral: Diagnosis of variceal bleeding and dits control in cirrhosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhotic patients admitted for an acute complication of cirrhosis admission ≤ 6 hours of inclusion Exclusion Criteria: Child-Pugh score > 13 Digestive hemorrhage Non cirrhotic portal hypertension

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Diagnosis of variceal bleeding and dits control in cirrhosis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variceal bleeding |  |  |
Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens

Study Overview
=================
Brief Summary
-----------------
Minimally invasive techniques have been widely used routinely and reliably in the treatment of pilonidal sinus. In some of these methods, the cavity of sinus remains in the patient; this condition caused us to question the necessity of pathological examination. Except for prolonged duration of disease, elderly age, macroscopic suspicion, and recurrence; We think that routine pathological examination of the pilonidal sinus is unnecessary.

Detailed Description
-----------------
Pilonidal sinus is a benign disease. In the histopathological examination of pilonidal sinus specimens, malignancy can be detected rarely. Minimally invasive techniques have been widely used routinely and reliably in the treatment of pilonidal sinus. In some of these methods, the cavity of sinus remains in the patient; this condition caused us to question the necessity of pathological examination. The investigators aimed to discuss the pathological findings of patients who were operated for pilonidal sinus in our clinic in light of the literature. The fact that the rate of malignancy in the literature does not show parallelism with minimally invasive procedures that pathology samples are not taken and whose applications are increasing supports this prediction. Except for prolonged duration of disease, elderly age, macroscopic suspicion, and recurrence; the investigators think that routine pathological examination of the pilonidal sinus is unnecessary.

Official Title
-----------------
Routine Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens, Retrospective Analysis of 1971 Resections.

Conditions
-----------------
Pathology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sacrococcygeal pilonidal sinus Exclusion Criteria: non-sacrococcygeal pilonidal sinus minimally invasive treatment without histopathological examination
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 |
| --- | --- | --- |
| Incidental cancer | Routine Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens | 2 or 3 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pilonidal sinus, carcinoma, pathology, squamous cell carcinoma, phenol
Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the effect of Tysabri on cognition in multiple sclerosis (MS) patients. During a period of 24 months, the study will assess the evolution of cognitive function in Tysabri treated MS patients using the Symbol Digit Modalities Test (SDMT) and the CogState battery of tests.

Detailed Description
-----------------
Tysabri reduces the relapse frequency, slows progression and preserves cognitive function as compared to placebo as per the AFFIRM trial. The benefit on relapse rate and progression appears to be sustained in longer-term studies such as STRATA. In clinical practice however despite a stable condition on the Expanded Disability Status Scale (EDSS) patients often complain of cognitive deterioration. It has yet to be shown that Tysabri will prevent cognitive deterioration after more than 2 years of treatment. The Symbol Digit Modalities Test (SDMT) is a sensitive and validated test of cognition in MS. CogState offers a standardized battery of cognitive tests frequently used in clinical research in the fields of dementia and Parkinson's disease. The CogState battery of tests consisting of the Detection test (processing speed), Identification test (attention), One Back test (working memory), International Shopping List test (verbal learning) and the Groton Maze Learning test (reasoning and problem solving) will further confirm and validate the results of the Symbol Digit Modalities Test(SDMT) in MS patients as well as examine other cognitive parameters. Together the above tests done prospectively can assess the evolution of cognitive function in Tysabri treated MS patients over the longer term.

Official Title
-----------------
Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with multiple sclerosis who are receiving Tysabri per indication and are willing and able to give an informed consent. Exclusion Criteria: Patients who are depressed as per the Beck depression questionnaire at screening or at any time during the study. Patients with cognitive decline from causes other than MS.

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 |
| --- | --- |
| cognitive evolution, observational,MS<br>multiple sclerosis tysabri treated patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SDMT CogState battery | Monthly cognitive assessments | 2 years |
Crucial Areas on AF Termination

Study Overview
=================
Brief Summary
-----------------
Recent data has demonstrated that focal sources are determinant in human atrial fibrillation (AF) perpetuation. The investigators sought to identify crucial areas for AF perpetuation during our routine electrogram (EGM)-based substrate ablation.

Official Title
-----------------
Crucial Areas on Atrial Fibrillation Termination by Substrate Ablation: Relevance to Anatomy

Conditions
-----------------
Atrial Fibrilation Termination Endpoint

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atrial Fibrilation Undergoing EGM-based substrate ablation Exclusion Criteria: Age < 18

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 |
| --- | --- | --- |
| Atria fibrillation termination during procedure | conversion to atrial tachycardia (AT) or sinus rhythm | 240 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crucial points | Crucial points were defined by areas where ablation immediately extended the cycle length> 20% of AF CL, or regularized Atrial Fibrilation (AF) into Atrial Tachycardia (AT) or converted AF (or AT) into Sinus Rythm | 240 min |
Procalcitonin in Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
the value of serum procalcitonin in differentiation between bacterial infection and non infectious inflammation in febrile HCC patients following locoeregional treatment for HCC.

Official Title
-----------------
Role of Procalcitonin in Differantiation Between Bacerial Infection and Non Infectious Inflammation in Febrile Hepatocellular Carcinoma Patients After Locoregional Treatment

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Hepatocellular carcinoma patients who will undergo TACE and/or radio-frequency. - Fever more than 38C after 48 hours post intervention. Exclusion Criteria: HCC Patients who does not develop fever after intervention. Proven infection elsewhere (e.g. UTI, chest infection..)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Patients with hepatocellular carcinoma<br>Patients with hepatocellular carcinoma who will undergo locoregional therapy | |
| patients with chronic liver disease<br>patients with chronic liver disease, as a control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differantiate between post- embolization syndrom and sepsis following locoregional treatment for hepatocellular carcinoma |  | 6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatocellular carcinom, postablation syndrom, procalcitonin
Downhill Walking Training in COPD

Study Overview
=================
Brief Summary
-----------------
This randomized control trial will investigate whether a modality that generates more contractile muscle fatigue with lower ventilatory requirements render better results after a 12-week exercise training program in subjects with COPD. Subjects will be randomized to either exercise in a training program including downhill walking or to exercise in a training program including conventional walking.

Official Title
-----------------
Downhill Walking to Enhance Training Effects in Patients With COPD

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Other: Downhill walking training
* Other: Conventional walking training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a primary diagnosis of COPD according to internationally accepted guidelines Patients referred to the outpatient PR program of Gasthuisberg University Hospital(Leuven, Belgium) Exclusion Criteria: Any underlying disease or musculoskeletal limitation that could impair the ability to perform any of the exercise training modalities Absence of exacerbations in the previous month before entering the present study Patients included on the waiting list for lung transplantation
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Downhill walking training<br>Exercise training including treadmill walking with a negative inclination. | Other: Downhill walking training<br>* Walk on a treadmill with a negative inclination.<br>|
| Active Comparator: Conventional walking training<br>Exercise training including treadmill walking without inclination. Possible to progress training intensity with positive inclinations. | Other: Conventional walking training<br>* Walk on a treadmill without inclination. Possible to progress training intensity with positive inclinations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in 6-minute walking distance |  | changes from baseline to Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary disease, chronic obstructive, Downhill walking, exercise
MORE - Monitoring Revlimid - Collecting of Patient Information From Myelodysplastic Syndrome (MDS) Italian National Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect clinical and laboratory data for patients affected by intermediate 1 and low risk Myelodysplastic Syndrome (MDS) associated by deletion 5q who were prescribed Revlimid from 31October 2008 to present. Revlimid is available in Italy for these patients since October 2008 based on a local disposition of the Italian Drug Agency (AIFA) issued according to a National law named 648/96.

Detailed Description
-----------------
There will be retrospective collection and integration of clinical laboratory data as well as prospective data collection on the same patients.

Official Title
-----------------
Observational, Non-interventional, Multicenter Study Aimed at Collecting Retrospective/Prospective 648/96 Italian Registry Data Related to Lenalidomide (Revlimid®) Prescription to Patients With Myelodysplastic Syndromes

Conditions
-----------------
Myelodysplastic Syndrome

Intervention / Treatment
-----------------
* Drug: lenalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intermediate 1 and low risk MDS patients associated with: transfusion dependency anemia (at least 2 units per 8 weeks before starting of Revlimid treatment ) 5q31-33 deletion isolated or associated to other chromosomal abnormalities. Exclusion Criteria: patients with serum creatinine > 2.5mg/dl child bearing potential females who do not use adequate contraceptive methods

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

| Intervention/Treatment |
| --- |
|Drug: lenalidomide|Patients who were prescribed Revlimid from 31October 2008 to present.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects achieving red blood cell (RBC) transfusion independence |  | 14 months | 
| Number of subjects achieving an erythroid response |  | 14 months | 
| Number of subjects achieving a cytogenetic response |  | 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | 14 months | 
| Duration of RBC transfusion independence |  | 14 months | 
| Duration of cytogenetic response |  | 14 months | 
| Time to RBC transfusion independence |  | 14 months | 
| Progression to acute myeloid leukemia (AML) |  | 14 months | 
| Number of participants alive |  | 14 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MORE, Monitoring Revlimid, Myelodysplastic Syndrome, Transfusion-dependent anemia, 5q deletion, lenalidomide
4beta-hydroxycholesterol in Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The aim is to evaluate the levels of oxysterols and especially 4beta-hydroxycholesterol in patients with liver cirrhosis. Three cirrhosis cohorts are recruited: patients treated with spironolactone, patients treated with rifaximin, patients without spironolactone or rifaximin. Also three other control cohorts are recruited: patients with pneumonia, patients with Crohn's disease, patients with ulcerative colitis. The effect of the cirrhosis and its medications spironolactone and rifaximin are compared to control groups.

Official Title
-----------------
4beta-hydroksikolesteroli Maksakirroosissa

Conditions
-----------------
Cirrhosis, Liver

Intervention / Treatment
-----------------
* Other: There is no intervention, only research blood samples are collected


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cirrhosis, pneumonia, Crohn's disease or colitis ulcerosa Treated in the ward 42 of the Oulu University Hospital Exclusion Criteria: None

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 |
| --- | --- |
| Liver cirrhosis with spironolactone<br> | Other: There is no intervention, only research blood samples are collected<br>* Research blood samples collected<br>|
| Liver cirrhosis with rifaximin<br> | Other: There is no intervention, only research blood samples are collected<br>* Research blood samples collected<br>|
| Liver cirrhosis without spironolactone or rifaximin<br> | Other: There is no intervention, only research blood samples are collected<br>* Research blood samples collected<br>|
| Pneumonia<br> | Other: There is no intervention, only research blood samples are collected<br>* Research blood samples collected<br>|
| Crohn's disease<br> | Other: There is no intervention, only research blood samples are collected<br>* Research blood samples collected<br>|
| Ulcerative colitis<br> | Other: There is no intervention, only research blood samples are collected<br>* Research blood samples collected<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood 4beta-hydroxycholesterol concentration | Blood 4beta-hydroxycholesterol concentration | At the time point of the blood collection - cross-sectional. One day. |
Smart Phone Application in Increasing Physical Activity in Breast Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
This pilot clinical trial studies how well a smart phone application works in increasing physical activity in breast cancer survivors. A smart phone application that increases physical activity may help reduce the likelihood of cancer coming back in breast cancer survivors.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To conduct a pilot study to inform the design of a mobile health application for smartphone that is targeted to increase physical activity and reduce risks associated with breast cancer.

Official Title
-----------------
Facilitating Motivational Readiness and Adoption of Physical Activity by Breast Cancer Survivors With a Smart Phone Application

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

Intervention / Treatment
-----------------
* Device: Smart Phone Monitoring Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A participant is only able to participate in one phase, not both phases, of the research study Must have completed breast cancer treatment Those on adjuvant hormonal therapy are allowed to participate in the research study (either phase) Exclusion Criteria: Those who currently meet the Centers for Disease Control and Prevention (CDC)'s physical activity guidelines Those who do not currently use a smartphone (of any kind) Those who do not read and speak English
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (smart phone application)<br>Participants download the physical activity readiness smart phone application onto their personal smartphone and receive training on how to use the app which includes animated video clips, tailored email reminders, and feedback on progress for 3 weeks. | Device: Smart Phone Monitoring Device<br>* Use activity tracker application<br>* Other names: Monitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Features of the mobile application that were most used by participants | Descriptive statistics using proportions and 90% confidence intervals will be calculated for various features. | 3 weeks |