linjc16/ctgov huggingface dataset:
Bacterially-synthesized Folate Absorption Across the Large Intestine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether folate produced by bacteria that live in our colon can be absorbed in human colon using a stable isotope method. This study would lead a better understanding of the bioavailability of colonic bacterially-synthesized folate and its quantitative contribution to whole body folate homeostasis.

Official Title
-----------------
Is Bacterially-Synthesized Folate Absorbed Across the Colon of Humans?

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

Intervention / Treatment
-----------------
* Dietary Supplement: 13C6-p-aminobenzoic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years; overall healthy Exclusion Criteria: <18 years or >65 years chronic disease (eg. history of hepatic, gastrointestinal, renal, vascular, haematological or neuropsychiatric disease) or surgery affecting gastrointestinal motility, pH or folate absorption/metabolism regular use of medications affecting gastrointestinal pH, motility or folate absorption/metabolism (eg. antiacids, laxatives, phenytoin, sulfasalzine, phenobarbital, primidone, cimetidine, proton pump inhibitors [such as Nexium] and antibiotics [such as Sulfonamides] or nonsteroidal anti-inflammatory drugs [NSAIDS, such as aspirin/ibuprofen]) consumption of >1 drink/day of alcohol on a regular basis or current smoking (last 6 months) planning a pregnancy, pregnant, breast feeding or the use of high-dose estrogen oral contraceptives/hormone replacement therapy known sensitivity to sunscreens containing ultraviolet B filters and/or PABA difficulty with swallowing large pills or providing venous blood samples

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1mg of 13C6-p-aminobenzoic acid<br> | Dietary Supplement: 13C6-p-aminobenzoic acid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in isotopic folate overtime in blood |  | Baseline (day 1), Days 2-4 ( 0h,1h,2h,3h,4h,5h,6h,7h,8h,9h,10h,11h,12h,24hr,48hr) | 
| Change in isotopic folate overtime in urine |  | Day 1 (0-24hr), Day 2 (25-48hr), Day 3 ( 49-72hr), Day 4 (73-96hr) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Folate intake | Assessed using food records | Day1-4 | 
| Fiber intake | Assessed using food records | Day1-4 |
Extension Study to Assess Tolerability and Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Recipients Who Received Mycophenolate Mofetil

Study Overview
=================
Brief Summary
-----------------
This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.

Official Title
-----------------
A One Arm, Open-label Study to Investigate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Recipients Who Received Mycophenolate Mofetil (MMF)

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion/ Exclusion criteria - Only patients who were participating in study CERL080A2405-DE02 and have completed the first 6 months of the core study can be included in this additional extension study. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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 |
| --- |
|Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/tolerability based on adverse events within 6 months after switching patients from MMF to optimized enteric-coated mycophenolate sodium. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety based on renal function within 6 months after medication switch. |  |  | 
| Pharmacokinetics (PK) in a randomized subpopulation. |  |  | 
| Efficacy measured by the incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch. |  |  | 
| Efficacy measured by the incidence of biopsy-proven acute rejection 6 months post medication switch. |  |  | 
| Graft survival and patient survival 6 months post medication switch. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS)
Tomography Positron Emission Assessment of the Impact of Cardiac Rehabilitation on Coronary Endothelial Function in Cardiac Failure

Study Overview
=================
Brief Summary
-----------------
In patients with heart failure, the drive to the effort has demonstrated its safety and its interest. Patients with heart failure, endothelium-dependent peripheral vasodilatation is impaired by decreased activity of endothelial NO synthase. The rehabilitation training significantly improves peripheral endothelial function, and this improvement is correlated to the increase in exercise capacity. The impact on coronary endothelial function remains poorly documented, especially in non-ischemic dilated heart disease. The main objective of this study is to investigate the effectiveness of cardiac rehabilitation on the restoration of coronary endothelial function in cardiac failure patient evaluated with Tomography Positron Emission 15O-H2O.

Conditions
-----------------
Cardiac Failure

Intervention / Treatment
-----------------
* Procedure: cardiac Rehabilitation
* Other: Tomography Positron Emission


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with heart failure with nonischemic dilated cardiomyopathy Class II-III NYHA (New York Heart Association) Having no contra-indication to the effort Fraction Ejection ≤ 40% patient who will have cardiac rehabilitation Age over 18 years informed consent signed patient with a social security scheme Exclusion Criteria: Hypertension> 160/90 mmHg High cholesterol level > 6.0 mmol / l Diabetes known and treated Active smoking Valvular heart disease, congenital or ischemic Pregnant or breastfeeding women Age <18 years Major Adult guardianship

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cardiac Rehabilitation<br> | Procedure: cardiac Rehabilitation<br> <br> Other: Tomography Positron Emission<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of myocardial blood flow during the cold test |  | change over baseline and after 3 month |
Glivec® Plus m-FOLFOX Avastin® in Advanced Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This is a Phase I, dose finding, multicentre study evaluating the maximal tolerated dose of Glivec® in combination with mFOLFOX-Avastin®. Patients will be enrolled into each dose level in 3 patient cohorts. Additional cohorts will be enrolled, or dose levels opened, subject to the toxicities observed. Once the MTD has been determined the dose level below will be re-opened and extra patients, to a total of 15, will be enrolled.

Conditions
-----------------
Advanced Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed, locally advanced, recurrent or metastatic colorectal cancer ECOG 0 or 1 Measurable disease Exclusion Criteria: Prior first line therapy for advanced disease Significant bulk of metastatic disease or rapid progression If prior adjuvant therapy, relapse within 6 months of a 5-FU based regimen or 12 months of an oxaliplatin based regimen Other protocol-defined inclusion/exclusion criteria may apply

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glivec®, modified FOLFOX, Avastin®<br> | Drug: Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour response as assessed by CT scan and RESIST |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal,, Cancer
The Use of Impella RP Support System in Patients With Right Heart Failure

Study Overview
=================
Brief Summary
-----------------
The use of Impella RP is safe, feasible and provides a hemodynamic benefit in patients with right ventricular failure.

Official Title
-----------------
The Use of Impella RP Support System in Patients With Right Heart Failure: A Clinical and Probable Benefit Study

Conditions
-----------------
Right Heart Failure

Intervention / Treatment
-----------------
* Device: IMPELLA® RP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that have developed signs of right ventricular failure either: A) within 48 hours post-implantation of an FDA approved implantable surgical LVAD (left ventricular assist device )(Cohort A) or B) subsequent to postcardiotomy shock within 48 hours post surgery or post myocardial infarction (Cohort B). Age ≥18 years old Signed Informed consent Exclusion Criteria INTERMACS 1 patients (Critical cardiogenic shock patient who is crashing and burning, has life-threatening hypotension and rapidly escalating inotropic or pressor support, with critical organ hypoperfusion often confirmed by worsening acidosis and lactate levels) Evidence of acute neurologic injury RA(right atrium),RV (right Ventricle) and/or PA (pulmonary artery) thrombus Intolerance to anticoagulant or antiplatelet therapies Existing congenital heart disease that would preclude the insertion of the device. Participation in any other clinical investigation that is likely to confound study results or affect study outcome Acute Myocardial Infarction (AMI) with mechanical complications ( ventricular septal defect, myocardial rupture, papillary muscle rupture)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Device: IMPELLA® RP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Benefit Endpoint | Survival at 30 days or hospital discharge whichever is longer post device explant or to the next therapy, including transplant, bridge to transplant or destination therapy with FDA approved surgical VAD (Ventricular Assit Device). | 30 Days |
Evaluation of the Efficacy of Diafert in Predicting Embryos' Potential to Develop to the Blastocyst Stage

Study Overview
=================
Brief Summary
-----------------
This prospective study will evaluate the efficacy of Diafert as an adjunct to morphological assessment in predicting embryos' potential to develop to the blastocyst stage on Day 5.

Official Title
-----------------
A Prospective, Non-interventional, Multicenter, Clinical Study to Evaluate the Efficacy of the Diafert G-CSF ELISA as an Adjunct to Morphological Assessment in Predicting Embryos' Potential to Develop to the Blastocyst Stage

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Device: Diafert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written informed consent before initiation of any study procedures Be a female outpatient, ≥ 18 years of age at the time of informed consent Have at minimum 10 mature egg follicles as of the last transvaginal ultrasound following hormonal stimulation Eligible to allow embryos to develop through day 5 before implantation or freezing Exclusion Criteria: Presence of ovarian endometriotic cyst Presence or history of diagnosed severe endometriosis (i.e. stage IV the revised American Fertility Society classification for endometriosis). Need for pre-implantation genetic diagnosis/screening of embryos Use of time-lapse embryo imaging Employee or immediate relative of an employee of Forest Research Institute, Inc., any of its affiliates or partners, or the study center

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non treatment group<br>This is a non-interventional study in which embryo selection is performed according to standard of care. The Diafert output, the granulocyte colony-stimulating factor (G-CSF) concentration in follicular fluid (FF), will be recorded but will not be used in patient management, ie, values will not be used for embryo selection in the assisted reproduction procedure. | Device: Diafert<br>* The Diafert output, the G-CSF concentration in FF, will be recorded but will not be used in patient management.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Embryos that achieve the blastocyst stage of development at Day 5 as determined by morphological assessment using the SART criteria | The status of each embryo will be assessed by an independent panel of 5 embryologists through visual inspection using the Society for Assisted Reproductive Technology (SART) criteria to determine if each embryo has achieved the blastocyst stage of development or not. | Day 5 |
World Health Organization Disability Assessment Schedule II (WHODAS-II) for Patients With Symptomatic Lumbar Spinal Stenosis

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to determine the measurement characteristics of WHODAS-II (World Health Organization Disability Assessment Schedule II), as well as to analyze its correlation with symptomatic lumbar spinal stenosis (Visual Analog Scale, VAS), disability (Spanish version of the Roland Morris Questionnaire, RMQ), fear avoidance beliefs and attitudes (Spanish version of the FAB Questionnaire, FABQ), and quality of life (SF-12). Measurements will be taken at baseline and 6 days later (day 7).

Official Title
-----------------
WHODAS-II for Patients With Symptomatic Lumbar Spinal Stenosis

Conditions
-----------------
Lumbar Spinal Stenosis

Intervention / Treatment
-----------------
* Other: WHODAS II (World Health Organization Disability Assessment Schedule II)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients seen for symptomatic lumbar spinal stenosis With signs of neurogenous claudication MRI or CAT scan concordant with observed signs Able to read and write Have signed the informed consent form Exclusion Criteria: Central nervous system pathology (with or without treatment) Diagnosis of rheumatic inflammatory disease or fibromyalgia Red flags for underlying systemic disease Criteria for diagnosis of disc herniation Symptoms suggesting saddle anesthesia, cauda equina, loss of sphincter tone or paraparesis Motor deficit that progresses or does not improve in 6 weeks

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 |
| --- | --- |
| 1<br>Measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule). | Other: WHODAS II (World Health Organization Disability Assessment Schedule II)<br>* To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement characteristics of WHODAS-II |  | At baseline and at 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in symptomatic lumbar spinal stenosis |  | At baseline and at 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
symptomatic, lumbar spinal stenosis, disability, fear avoidance beliefs, quality of life
A Cross-Sectional Natural History Study to Evaluate Sweat Volume and Other Phenotypic and Genetic Characteristics in Patients Affected by XLHED

Study Overview
=================
Brief Summary
-----------------
The proposed natural history study will enroll male patients with a diagnosis of XLHED, female carriers of XLHED and healthy volunteers. The study protocol will include collection of XLHED questionnaires and clinical outcomes using minimally invasive technologies. Data will be collected both retrospectively and prospectively. Clinical outcome assessments will be performed at the NFED Family Conference on July 11-12, 2019. Study participants will be able to complete XLHED questionnaires electronically ahead of the conference.

Official Title
-----------------
A Cross-Sectional Natural History Study to Evaluate Sweat Volume and Other Phenotypic and Genetic Characteristics in Patients Affected by X-Linked Hypohidrotic XLHED Ectodermal Dysplasia (XLHED)

Conditions
-----------------
XLHED

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed Consent Males with XLHED, female carriers of XLHED and healthy volunteers Exclusion Criteria: Treatment with an investigational study drug for XLHED Any major medical problems that would prevent her/him from participating in this study Known hypersensitivity to pilocarpine or pilocarpine-like muscarinic agonists (Examples: Urecholine, Salagen, Pilocar, and Provocholine) Pacemaker

Ages Eligible for Study
-----------------
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| XLHED Patients<br> | |
| Healthy Controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The volume of sweat from a pilocarpine-induced sweat test |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Natural History Study, X-Linked Hypohidrotic Ectodermal Dysplasia
Synovitis in Patients With Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
To study synovial membrane (SM) inflammation in suprapatellar fossa in advanced knee osteoarthritis (OA), and to correlate the pathological features with clinical findings.

Official Title
-----------------
Correlations Between Microscopic Features of Synovium and Clinical Parameters in Patients With Advanced Osteoarthritis

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Procedure: Total knee arthroplasty due to advanced osteoarthritis.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective, unilateral, primary TKA for advanced osteoarthritis. Exclusion Criteria: - revisions, bilateral procedures, alcohol or medical abuse, administration of any glucocorticoids during the 3 months prior to surgery, and/or a history of serious cardiac or cerebrovascular problems, severe liver or kidney failure, and/or connective tissue disease including rheumatoid arthritis, ankylosing spondylitis, and systemic lupus erythematosus.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 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 undergone TKA due to advanced knee osteoarthritis<br> | Procedure: Total knee arthroplasty due to advanced osteoarthritis.<br>* Postoperative usage of intravenous methylprednisolone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between pathological features and clinical scores |  | 1 day. | 
| Correlation between pathological features and laboratory index |  | 1 day |