linjc16/ctgov huggingface dataset:
Prospective and Retrospective Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and During Treatment or Thereafter in Acute Leukemia (Acute Leukemia HSCT Cohort)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the prognostic factors of acute leukemia patients received stem cell transplantation and to invent the molecular genetic test for sensitive detection of minimal residual disease, and thereby this study would contribute to plan the risk adapted treatment. Patients will have samples of blood and/or bone marrow collected during treatment or thereafter

Conditions
-----------------
Acute Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with acute leukemia who underwent allo-HSCT in Severance Hospital. Both genders of 16 Years and older sign a written informed consent document exemption of consent in patient who died in study period. Exclusion Criteria: No comprehension or willingness to sign a written informed consent document.

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Overall survival | Overall survival (OS) is defined as the time from date of diagnosis until death due to any cause within the follow-up period. Surviving patients are censored at date of last contact. | 10years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival (PFS) is defined as survival without disease progression or relapse; patients alive without disease progression or relapse are censored on the last assessment date. Median OS and PFS are calculated using Kaplan-Meier estimates with a 95% confidence interval. | 10years | 
| Treatment-related mortality | Treatment-related mortality was defined as death unrelated to refractory or progressive disease occurring before first remission was achieved, or any death in complete remission | 10years | 
| Complete remission rate | Response assessment is performed according to the criteria reported by BD Cheson et al. (Revised recommendations of the international working group for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia) | 10 years |
Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases

Study Overview
=================
Brief Summary
-----------------
Inflammatory Bowel Diseases (IBDs) are a set of recurrent inflammatory conditions that include the colon and small intestine. The two principal conditions include Crohn's disease (CD) and ulcerative colitis (UC). The etiology of which is likely to stem from the interplay of gut microbial imbalances and host. In this study stool cultures, saliva and skin samples will be taken from all participants.

Detailed Description
-----------------
Recent studies have shown that certain CD patients harbor microbial communities that are distinct from those of healthy individuals. These studies suggest a central role of the gut microbial population in CD. The high complexity of the gut microbiome, which is the most densely populated bacterial niche, makes the identification of these bacteria a significant challenge. The bacterial population is comprised from 1013 - 1014 individuals, all belonging roughly to a thousand different species, mostly anaerobic, and most of them (roughly 70% - 80%) are uncultivable. The goals of this project are to examine a potential link between bilirubin metabolism and IBD, by comparing fecal extracts from healthy humans and IBD patients, and to investigate the underlying mechanism explaining these differences.

Official Title
-----------------
Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases

Conditions
-----------------
Colitis, Ulcerative, Crohn Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: UC CD healthy Volunteers Exclusion Criteria: • N/A
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 |
| --- | --- |
| ulcerative colitis patient<br>people that have UC diagnosis can participate in the study. the disease can be at any level and the patients can handle any medications. | |
| CD patient<br>people that have CD diagnosis can participate in the study. the disease can be at any label and the patients can handle any medications. | |
| Health people<br>control group. no IBD patients can be included. patients with other diseases can be included. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of bilirubin metabolism in fecal samples | liquid chromatography / mass spectrometric (LCMS) analysis is applied to bilirubin metabolism comparison between IBD patients and healthy humans in fecal extracts | an average of 1 year after recruitment | 
| microbial diversity of fecal matter | 16S rRNA sequencing, is used to compare the microbial diversity between healthy individuals and IBD patients | an average of 1 year after recruitment |
Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Colorectal cancer (CRC) is the second most common cancer and the fourth leading cause of cancer death in Korea. Colonoscopy with polypectomy decreases the incidence and mortality from colorectal cancer. However, significant lesions can be missed during colonoscopy. Recent retrospective studies have shown that fellow involvement as a second observer may increase adenoma detection rate in colonoscopy. The aim of this prospective, multicenter, randomized study is to evaluate the impact when endoscopy nurse participate in adenoma detection during screening colonoscopy. The primary outcome measure is the adenoma detection rate (ADR).

Official Title
-----------------
Can Involvement of Endoscopy Nurse Participation Increase Adenoma Detection Rate During Screening Colonoscopy?:A Prospective Multicenter Randomized Trial

Conditions
-----------------
Polyp, Adenomatous Polyp, Colonoscopy

Intervention / Treatment
-----------------
* Procedure: standard of care colonoscopy
* Procedure: standard of care colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 50 screening colonoscopy Exclusion Criteria: History of colorectal surgery History of hereditary colorectal cancers or polyposis syndrome Gastrointestinal bleeding Inflammatory bowel diseases Inability to provide informed consent Pregnancy

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endoscopist only<br> | Procedure: standard of care colonoscopy<br>* Single inspection by endoscopist during colonoscopy<br>|
| Experimental: nurse participation<br> | Procedure: standard of care colonoscopy<br>* Dual inspection by both endoscopist and nurse during colonoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adenoma detection rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjects with at least one polyp |  | 1 year | 
| Subjects with at least one adenoma |  | 1 year | 
| total number of polyp |  | 1 year | 
| total number of adenoma |  | 1 year | 
| Subjects with at least one advanced adenoma or cancer |  | 1 year | 
| total number of advanced adenoma or cancer |  | 1 year | 
| polyp and adenoma detection rate according to the endoscopists or nurse experience |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
polyp, adenoma, screening, colonoscopy, diagnosis
Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury

Study Overview
=================
Brief Summary
-----------------
The investigators predict that decreased heart rate variability and poor sleep quality will be significantly correlated with higher self-reported anxiety following brain injury.

Detailed Description
-----------------
Acute rehabilitation inpatients with moderate-to-severe brain injury will wear biosensors that track total sleep time and heart-rate variability for up to 1 week. During this time the participants will also complete surveys regarding symptoms of anxiety. The investigators hypothesize that decreased heart rate variability and poor sleep quality will be significantly correlated with higher self-reported anxiety following brain injury.

Official Title
-----------------
Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury

Conditions
-----------------
Traumatic Brain Injury, Anxiety

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: traumatic brain injury injury within past 6 months medically stable able to communicate Exclusion Criteria: on medication: beta-blocker adverse skin reaction to biosensor adhesive non-English speaking pregnant women prisoners

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 |
| --- | --- |
| Moderate-to-severe traumatic brain injury inpatients<br>Moderate-to-severe traumatic brain injury inpatients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety | self-reported anxiety survey | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate variability | Skin biosensor on patient chest, measuring heart rate over 6 minute interval while patient is awake and resting. Then heart rate variability is calculated based on the R-R interval. | 48 hours | 
| sleep | self-reported sleep survey. Also skin biosensor measuring heart rate and accelerometer overnight for 2 consecutive nights. Total sleep time and awakening episodes will be derived from the biosensor data. | 48 hours | 
| post-traumatic stress disorder (PTSD) | self-reported survey of PTSD symptoms | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart rate variability, sleep
Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft

Study Overview
=================
Brief Summary
-----------------
To compare the aortic pulse profile before and after stent-graft implantation to prove that endovascular AAA repair using non-compliant stent-graft changes the aortic pulse profile.

Detailed Description
-----------------
This study will assess hemodynamic changes in aortas of patients after treatment of their abdominal aortic aneurysm (AAA) with an FDA approved stent-graft (Zenith). This study does not require any change in clinical protocol to the the way the AAA procedures are currently done. Utilizing the catheters already employed in this procedure, intravascular blood pressure measurements will be documented at various times and at various anatomic levels prior to and after deployment of the stent-graft. As the compliant aortic aneurysm acts as a capacitor, expanding during systole and contracting during diastole, it is our hypothesis that endovascular AAA repair using a non-compliant stent-graft changes the aortic pulse profile.

Official Title
-----------------
Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft

Conditions
-----------------
Abdominal Aortic Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Abdominal Aortic Aneurysm with planned treatment using Zenith Endovascular Stent-Graft
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abdominal, aortic, aneurysm, Zenith, blood pressure
Tifacogin for the Treatment of Patients With Severe Community-Acquired Pneumonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether tifacogin is effective and safe in the treatment of patients with severe community-acquired pneumonia.

Official Title
-----------------
Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) for the Treatment of Patients With Severe Community-Acquired Pneumonia

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Drug: Tifacogin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of community-acquired pneumonia supported by additional clinical, radiological, and microbiological evidence Pneumonia of sufficient severity to require ICU admission and management Exclusion Criteria: Pregnancy Weight over 150 kg Patients at increased risk of bleeding Treatment with drotrecogin alfa or anticipated need for drotrecogin alfa Treatment with heparin or anticipated need for heparin
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effect of tifacogin vs placebo administration. |  |  |
Using Real Time Biofeedback to Alter Running Mechanics

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are 1) to assess foot strike patterns initially, at six months and at one year between two groups of runners attempting to transition to a non-rearfoot strike pattern (NRFS) with and without the use of biofeedback technology, and 2) to prospectively compare injury incidence rates at one year between NRFS and rearfoot strike (RFS) runners.

Official Title
-----------------
Using Real Time Biofeedback to Alter Running Biomechanics

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Biofeedback Sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the age of 18 - 50 years Run on average 12mi per week DOD beneficiaries who intend to remain at West Point, NY for the next 12 months at time of study enrollment Read and speak English well enough to provide informed consent and follow study instructions Exclusion Criteria: Known pregnancy currently or in the previous 6 months Lower extremity or low back pain in the previous 3 months Lower extremity or low back surgery in the previous 6 months Any lower extremity or low back exercise limiting profile Previous stress fracture of the foot Participant who has a non-rearfoot strike running pattern

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Group does not receive the biofeedback sensor | |
| Experimental: Biofeedback group<br>Group does receive the biofeedback sensor | Device: Biofeedback Sensor<br>* Tibia accelerometer strapped to distal tibia to detect tibial shock<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Foot strike pattern from Baseline | Foot strike pattern will be either classified as rearfoot strike or non-rearfoot strike. This is determined by video analysis of 240hz camera. | 6mo and 1yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injury Incidence |  | 1yr | 
| Cadence |  | 6mo and 1yr | 
| Relative Risk |  | 1yr |
Double Osteotomy for Deformity Correction in Pyle Disease

Study Overview
=================
Brief Summary
-----------------
Leg deformity is one of the features of Pyle disease( metaphyseal dysplasia). Correction of valgus deformity of the leg can be done after deformity analysis by double osteotomy so this study showed how double osteotomy can lead to better results than single osteotomy.

Official Title
-----------------
Double Osteotomy for Deformity Correction In Pyle Disease: Comparative Study

Conditions
-----------------
Pyle Disease

Intervention / Treatment
-----------------
* Procedure: Single osteotomy
* Procedure: Double Osteotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pyle Disease Exclusion Criteria: Smoking Diabets Mellitus Previous surgery on the limbs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single tibial osteotomy<br>Single tibial osteotomy done to achieve correction | Procedure: Single osteotomy<br>* Single tibial osteotomy<br>|
| Active Comparator: Double tibial osteotomy<br>Double tibial osteotomy done to achieve correction | Procedure: Double Osteotomy<br>* Double Tibial Osteotomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical axis of lower limbs | This will determine how much the mechanical axes of the lower limbs were diverted from the normal values. We asked for lower limb radiograph in both Anteroposterior and lateral views and we measure the mechanical axes of the whole lower limb and that of tibial and measures how much the proximal medial tibial angle and compared with normal values | This mechanical axes were assessed one year after surgery | 
| Knee injury and Osteoarthritis outcome score | This score involves six sections from zero score to 100. The more score is better outcome | This score was assessed one year post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pyle disease, Genu valgus, Double Osteotomy, Deformity analysis, Functional outcome
Differential Diagnostics of Etiology of Acute Infections

Study Overview
=================
Brief Summary
-----------------
Method for diagnostics of the origin of infections (bacterial vs viral) based on the identification of activation markers of blood neutrophils and monocytes will be developed.

Detailed Description
-----------------
During the study, method for diagnostics of the origin of infections (bacterial vs viral) based on the identification of activation markers of blood neutrophils and monocytes will be developed.This method will allow to make a diagnosis within an hour after blood sampling. The expression of the following markers of activation will be studied using flow cytometry: CD11b, CD11c, CD13, CD16, CD32, CD35, CD38, CD62L, CD64, CD66b, CD88, CD284, HLA-ABC and HLA-DR.

Official Title
-----------------
Differential Diagnostics of Etiology of Acute Infections Based on the Analysis of Expression of Activation Markers on the Surface of Peripheral Blood Monocytes and Neutrophils.

Conditions
-----------------
Intestinal Infectious Diseases, Neuroinfections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neuroinfections or acute intestinal infections; the possibility of blood sampling within a period of up to 24 hours from the moment of admission to hospital; less than 72 hours passed after the onset of the disease and until blood was collected; Exclusion Criteria: refuse of patient to participate in the trial; more than 24 hours passed after the patient entered the hospital; the disease began more than 72 hours ago; concomitant severe acute and chronic diseases; malignant neoplasms, treatment at a time of less than 1 year, autoimmune diseases in the phase of exacerbation; pregnancy/lactation; HIV, Hepatites B/C; active tuberculosis; alcohol use disorder/drug addiction.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neuroinfections<br>Patients with acute neuroinfections of bacterial and viral ethology. | |
| Intestinal Infectious Diseases<br>Patients with acute intestinal infectious diseases of bacterial and viral ethology. | |
| Control group<br>Control group of healthy persons | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the diagnosis of bacterial vs viral acute infection | Sensitivity of the diagnosis of bacterial vs viral acute infection using proposed method | 1 month | 
| Specificity of the diagnosis of bacterial vs viral acute infection | Specificity of the diagnosis of bacterial vs viral acute infection using proposed method | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute Infections, flow cytometry, cell activation