linjc16/ctgov huggingface dataset:
Influence of Circulating Endothelial Progenitor Cells and Modifiable Vascular Risk Factors on Carotid Plaque Vulnerability

Study Overview
=================
Brief Summary
-----------------
Ischemic stroke is a leading cause of death and disability worldwide. Atherosclerosis, responsible for the 20% of ischemic strokes, is characterized by lipid accumulation in the artery wall that leads to chronic inflammation, cell proliferation and ultimately to vessel stenosis. One of the main features related to plaque progression and vulnerability is inflammation. Positron emission tomography with 18-fluorodeoxyglucos (18-FDG PET) allows an accurate quantification of plaque inflammation and it has been proved its usefulness in predicting early stroke recurrences. The investigators aim to test how modifiable vascular risk factors influence plaque inflammation assessed by 18-FDG PET. In addition, investigators will assess the association of this inflammation and circulating endothelial progenitor cells

Official Title
-----------------
Influence of Circulating Endothelial Progenitor Cells and Modifiable Vascular Risk Factors on Carotid Plaque Vulnerability

Conditions
-----------------
Atherosclerosis, Stroke, Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemic stroke within 7 days before inclusion At least one atherosclerotic plaque in the internal carotid artery >18 years old Exclusion Criteria: Cardioembolic strokes according to TOAST criteria Poor functional outcome (Rankin >3) after stroke

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 |
| --- | --- | --- |
| Change in the Standardized Uptake Value (SUV) of the internal carotid artery | Inflammation change of the internal carotid artery assessed by the Standardized Uptake Value (SUV) obtained with 18FDG-PET scan at one-year follow-up | Baseline and at one year follow-up | 
| Change in the Target-to-Background Ratio (TBR) of the internal carotid artery | Inflammation change of the internal carotid artery assessed by the Target-to-Background Ratio (TBR) obtained with 18FDG-PET scan at one-year follow-up | Baseline and at one year follow-up | 
| Change in the Endothelial Progenitor Cells Count | Change in the Endothelial Progenitor Cells Count by flow cytometry | Baseline and at one year follow-up |
Cognitive-behavioral Treatment for Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of Cognitive-behavioral treatment for people with rheumatoid arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Behavioral: Cognitive-behavioral treatment
* Behavioral: Waiting List


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed by rheumatology consultants with RA Exclusion Criteria: severe psychological difficulties currently receiving mental health care any medical condition that might prevent them from safely exercising (e.g. history of more severe heart, lung or cerebrovascular disease) previously attended an education programme had a Modified Health Assessment Questionnaire score >2 (score range 0-3), that is severe functional problems history of organic brain syndrome presence of a psychotic disorder presence of other uncontrolled medical disorders presence of a major communication disorder, illiteracy presence of less than an 8th grade education (due to inability to complete questionnaires) presence of a therapeutic dosage of an antidepressant medication, or presence of another autoimmune disease/disabling condition

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT<br>Cognitive-behavioral treatment | Behavioral: Cognitive-behavioral treatment<br> <br> |
| Sham Comparator: WLT<br>Waiting in list | Behavioral: Waiting List<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in disease activity score in 28 joints(DAS28) at 48 weeks |  | at 0 week, 12 weeks, 24 weeks, 48 weeks |
Effect of Symptom Management on Inflammation and Survival in Metastatic Lung Cancer

Study Overview
=================
Brief Summary
-----------------
There is a growing body of evidence that implicates inflammation as a mechanism of disease progression and reduced survival in patients with advanced cancer. Elevated c-reactive protein levels have been shown to be associated with reduced performance status, specific cancer related symptoms and reduced overall survival. C-reactive protein levels are a surrogate for IL-6 expression. IL-6 is part of an inflammatory signature predicting cancer recurrence. VeriStrat® is a multivariate test which measures protein expression related to a host/tumor interaction mediated by inflammation. The investigators hope to examine the relationship between quality of life outcomes per FACT-L survey and correlate them with changes in c-reactive protein levels and the VeriStrat® status. The hypothesis of this study is that the remarkable survival benefit in the Temel study is mediated by reduced inflammation with improvement of symptom control.

Official Title
-----------------
INSYNC: Leo Jenkins Cancer Center (LJCC) - Symptom Management Service (SMS) Protocol -Phase II Trial Regarding The Effect Of Comprehensive Symptom Management On Inflammation And Survival In Metastatic Lung Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of stage IV non-small cell lung cancer Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 Able to read and respond to questions in English Exclusion Criteria: Small Cell Lung Cancer

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 |
| --- | --- | --- |
| Overall Survival | Overall survival from diagnosis until death from any cause | Patients will be followed for 5 years after enrolling last patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who convert from c-reactive protein 'high' (> 10 mg/L) to 'low' (<10 mg/L) | Baseline versus 4 months Baseline versus 10 months 4 months versus 10 months | 10 months | 
| Quality of Life (QOL) indicators per FACT-L score and the following at baseline, 4 months and 10 months groups | VeriStrat Good and CRP low (<10 mg/L) VeriStrat Good and CRP high (>10 mg/L) VeriStrat Poor and CRP low (<10 mg/L) VeriStrat Poor and CRP high (>10 mg/L) | 10 months | 
| Change in VeriStrat status | Percentage of patients who convert from poor to good | 10 months |
Mechanisms Underlying Drug-Diet Interactions

Study Overview
=================
Brief Summary
-----------------
Similar to the well publicized grapefruit juice effect, ongoing studies are evaluating the interaction potential of other dietary substances on drug disposition. This study is designed to determine whether the mechanism underlying the enhancement of the anticoagulative effect of warfarin by cranberry juice is due to inhibition of warfarin metabolism by the juice. A secondary objective is to determine whether cranberry juice elicits a grapefruit juice-type interaction with midazolam.

Official Title
-----------------
Mechanisms Underlying Drug-Diet Interactions

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: warfarin, vitamin K, midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years of age Healthy Not taking medications known to modulate CYP2C9 and CYP3A activity Able to understand the consent process Exclusion Criteria: Allergy to cranberry products, warfarin, vitamin K, or midazolam Pregnant or breast-feeding women Baseline INR >1.2 History of significant medical conditions that could increase risk Concomitant medications known to modulate CYP2C9 and CYP3A activity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Water<br> | Drug: warfarin, vitamin K, midazolam<br>* warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)<br>* Other names: Versed;|
| Active Comparator: Cranberry juice<br> | Drug: warfarin, vitamin K, midazolam<br>* warfarin tablet single dose (10 mg) vitamin K tablet single dose (10 mg) midazolam syrup single dose (5 mg)<br>* Other names: Versed;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC |  | 0-96 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | varies | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
warfarin, midazolam, cranberry juice, pharmacokinetics
SURGICAL EXPERIENCE ON RENAL TRANSPLANT COMPLICATIONS

Study Overview
=================
Brief Summary
-----------------
Kidney transplantation (KT) failure could be due to surgery dependent factors and particularly surgeon's experience. Objective: To assess the impact of the surgeon's experience on the post-operative outcomes to know if it safe for young surgeons to perform it.

Official Title
-----------------
IMPACT OF SURGICAL EXPERIENCE ON RENAL TRANSPLANT COMPLICATIONS

Conditions
-----------------
Kidney Transplant Failure

Intervention / Treatment
-----------------
* Procedure: Kidney transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent Kidney Transplant in CHU of Nice Patient for whom a minimum of 12 months follow up is possible. Exclusion Criteria: - Patients who underwent a dual Kidney Transplant or a multi-organ transplant

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 |
| --- |
|Procedure: Kidney transplant|Transplant surgery of Kidney|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication post surgery | complication occurrence using the Clavien Dindo score | 1 month after transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| function of the transplanted kidney | concentration of the creatininemia | within 1 year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transplant, Kidney
The Effects of a High-fiber Formula in Children With Failure to Thrive

Study Overview
=================
Brief Summary
-----------------
The present study is designed to determine the gastrointestinal tolerability of enteral nutritional products, physicians and parents' overall perception of enteral nutrition products as well as providing basic demographic information on pediatric populations prescribed these formula for supportive treatment as part of the routine healthcare service in Turkey.

Official Title
-----------------
A Prospective, Open-label, Post-marketing Observational Study to Evaluate the Effects of High-fiber Enteral Pediatric Formula in Children With Failure to Thrive Due to Malnutrition

Conditions
-----------------
GI Tolerance

Intervention / Treatment
-----------------
* Other: pediatric formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age; 1-10 years (inclusive) Children diagnosed as failure-to-thrive(FTT). Children who have been recently prescribed and treatment initiated with isocaloric or hypercaloric high-fiber pediatric enteral formula suitable for oral and/or nasogastric tube feeding before inclusion in the study. Exclusion Criteria: Chronic renal disorder Decompensated liver disease Any other chronic condition that was not under control (e.g. diabetes, thyroid disorder, etc.) Any type of malignant disease including leukemia and lymphoma Cystic fibrosis Short bowel syndrome Any type of food allergy or intolerance Growth hormone deficiency Use of enteral feeding within the last 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: pediatric formula|high-fiber enteral formula|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Perception of Formula Use | Questionnaire | Baseline to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Tolerance | Subject questionnaires | Baseline to Month 1, Month 2, Month 4 and Month 6 | 
| Description of Population | Demographic collection of patients recommended high-fiber enteral formula | Baseline | 
| Weight |  | Baseline to Month 1, Month 2, Month 4 and Month 6 |
CT Perfusion Parameters for Advanced HCC Treated by Systemic Immunotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare CT perfusion parameters to RECIST 1.1 and mRECIST assessment for advanced HCC treated by systemic immunotherapy, and to evaluate perfusion parameters as predictive factors of response on baseline and on early follow-up

Official Title
-----------------
CT Perfusion Parameters for Advanced HCC Treated by Systemic Immunotherapy : a Pilot Study

Conditions
-----------------
Advanced HCC Treated by Systemic Immunotherapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years old Proved HCC Advanced HCC, defined as Barcelona Clinic Liver Classifications (BCLC) stage B non eligible for loco-regional therapy and stage C No prior systemic therapy Measurable disease per Response Evaluation Criteria for Solid Tumour (RECIST) v1.1 Child-Pugh Score = A Eastern Cooperative Oncology Group (ECOG) Performance Status < 2 Exclusion Criteria: Absence of CT perfusion before treatment initiation more than a two-month delay between treatment initiation and first post-treatment CT perfusion Uninterpretable CT perfusion Definitive contraindication to CT perfusion (allergy or advanced renal disease)

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 |
| --- | --- | --- |
| Comparison of CT perfusion parameters between the responders and non-responders according to RECIST 1.1 assessment for advanced HCC treated by systemic immunotherapy | Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 assessed by a senior radiologist. Comparison assessed by t test or Mann-Whitney test. | Through study completion, an average of 1 year | 
| Comparison of CT perfusion parameters between the responders and non-responders according to mRECIST assessment for advanced HCC treated by systemic immunotherapy | modified Response Evaluation Criteria in Solid Tumors (mRECIST) assessed by a senior radiologist. Comparison assessed by t test or Mann-Whitney test. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of CT perfusion parameters as predictive factors of response on baseline and on early follow-up | Assessed using logistic regression | Through study completion, an average of 1 year |
Value of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough

Study Overview
=================
Brief Summary
-----------------
As of September 2020, the COVID-19 pandemic has affected millions of people in 196 countries and left hundreds of thousands dead. After recovery it was found that up to 32% of cases had 1 or 2 symptoms, 55% had 3 or more Post-COVID-19 symptoms, and persistent Post COVID-19 cough was recorded in 29.3% of cases in one study. A recent study identified Montelukast, among the top-scoring clinically-oriented drugs likely to inhibit SARS-CoV-2 main protease. Besides its known effect that is reported to improve cough and prevent exercise-induced bronchoconstriction in asthma, many trials assessed Montelukast in the treatment of post-infectious cough and found variable effects. Despite that the exact mechanism is not yet identified, Barré and colleagues proposed several properties of Cyst LT1 receptor antagonists that are potentially beneficial in COVID-19.

Official Title
-----------------
Value of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough: A Randomized Controlled Pilot Study

Conditions
-----------------
Post COVID-19

Intervention / Treatment
-----------------
* Drug: Montelukast Sodium Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Post COVID-19 persistent cough after 4 weeks of acute attack Exclusion Criteria: Any contraindication to Montelukast, respiratory, cardiac disease, pregnancy, breastfeeding and use of angiotensin converting enzyme inhibitors.

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
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Montelukast treated<br> | Drug: Montelukast Sodium Tablets<br>* intervention group received standard cough therapy+ Montelukast 10 mg/day for 14 days<br>* Other names: Montelukast;|
| No Intervention: Standard treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cough severity index | Scale from mild to severe | 14 days | 
| Cough severity visual analog | Severity from 0-10 | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of drug | Nausea, vomiting, abdominal pain, restlessness, depression | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Montelukast, cough, cough severity
Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess whether or not low level laser therapy (LLLT) decreases pain in post-operative orthopedic patients following lumbar fusion surgery.

Detailed Description
-----------------
Lumbar fusion surgery patients typically experience significant post-operative pain for several weeks and their rehabilitation does not start until 8 - 12 weeks postoperatively. We hypothesize that LLLT beginning 4 weeks postoperatively will provide significant reduction in postoperative pain.

Official Title
-----------------
Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Device: Low Level Laser Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age > 18 and < 85 years Post-operative lumbar fusion surgery Currently resides within 100 miles of UMC Exclusion Criteria Pregnant Pacemaker Medications that have heat or light-sensitivity contraindications (such as: steroids, some antibiotics) Two or more cardiac risk factors Intraoperative complications Wound infection Spinal fluid leakage Open wound

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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 |
| --- | --- |
| No Intervention: 2<br>No Laser done. All outcome measures are the same. | |
| Experimental: 1<br>Low Level Laser Therapy | Device: Low Level Laser Therapy<br>* Low Level Laser Therapy done after surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FACES Pain Rating Scale |  | baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline | 
| Oswestry Low Back Pain Disability (ODQ) Questionnaire |  | baseline visit (2 weeks after the patient's surgery date) then 6,12, and 24 weeks thereafter | 
| Quality of Life - The Quality of Life Short-Form Survey (SF-36) |  | baseline visit (2 weeks after the patient's surgery date) then 6,12, and 24 weeks thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain medication usage |  | baseline (2 weeks after surgery), then 6,12, and 24 weeks from baseline | 
| Improvement measured by serial photographs of surgery appearance and rate of healing |  | 2 weeks after surgery, then 6, 12, and 24 weeks after surgery |