linjc16/ctgov huggingface dataset:
Ursodeoxycholic Acid in C. Difficile Infection

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to assess tolerability and adherence to treatment with ursodeoxycholic acid

Official Title
-----------------
Feasibility Studies to Investigate the Role of Ursodeoxycholic Acid in the Prevention of Recurrence of C. Difficile Infection

Conditions
-----------------
Clostridioides Difficile Infection

Intervention / Treatment
-----------------
* Drug: Ursodeoxycholic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of a course of antibiotic treatment for C. difficile infection within the previous 7 days Exclusion Criteria: • Pregnant or Breast-feeding Gall bladder inflammation Frequent episodes of biliary colic Occlusion of the common bile duct or cystic duct Active small intestinal inflammation Previous resection of distal small intestine Treatment with bile salt binding agents, ciclosporin or ciprofloxacin Diarrhoea (from any cause) at study initiation hypersensitivity to bile acids or any excipient of the formulation Life expectancy less than 6 months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ursodeoxycholic acid<br>Only one arm - subjects receiving ursodeoxycholic acid | Drug: Ursodeoxycholic acid<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess tolerability to oral ursodeoxycholic acid | Assess for side effects | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine recurrence of C. difficile infection in those able to take ursodeoxycholic acid | Recurrence of C. difficile infection to be confirmed by stool test for toxin(s) | 12 weeks |
Impact of Hemodialysis on Exhaled Volatile Organic Compounds in End Stage Renal Disease

Study Overview
=================
Brief Summary
-----------------
End stage renal disease (ESRD) is a severe clinical state of irreversible loss of endogenous kidney function, shortening life expectancy, if left untreated. In the state of ESRD, over 5000 uremic toxins are accumulated in the body causing dysfunction of various organ systems. The survival of these patients depends on renal replacement therapies, such as hemodialysis (HD), which artificially purifies the blood from toxins. The investigators assume that some of the uremic toxins are also present in the patient's exhaled breath, and could be detected by a non-invasive and highly sensitive test: a NA-NOSE artificial olfactory system. It is based on analysis of volatile organic compounds (VOCs), a novel, non-invasive field in medical diagnostics. The NA-NOSE is made from an array of nanosensors, and was developed by our collaborator Dr. Hossam Haick (Chemical Engineering, Technion). In the current study, the investigators utilize this technology to identify VOCs in the exhaled breath of dialysis patients, and to characterize certain patterns of expression that could potentially help in future monitoring of HD adequacy. The investigators plan to collect 150 breath samples from patients before and during dialysis, and from healthy subjects. All participants provide a signed informed consent. Subsequently, analysis of samples will be done at Dr. Haick's laboratory, using Gas-Chromatography/Mass-Spectrometry and parameters extracted from each sensor response.

Official Title
-----------------
Impact of Hemodialysis on Exhaled Volatile Organic Compounds in End Stage Renal Disease

Conditions
-----------------
End Stage Renal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 Years and older End stage renal disease receiving hemodialysis Exclusion Criteria: Age under 18 Pregnancy Malignancy Infectious diseases

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

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

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

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
-----------------
End stage renal disease, hemodialysis, breath test, volatile organic compound, dialysis adequacy
Validation of the MiCK Assay

Study Overview
=================
Brief Summary
-----------------
Testing Mayo Clinic cancer patients with the results being correlated with prior patient therapy, performance status, and extent of disease.

Detailed Description
-----------------
This study will be conducted in two phases. During the Feasibility Phase, specimens from any tumor will be sent to the central DiaTech MiCK assay laboratory to determine the ease of sample acquisition, processing, transport, and assay interpretation. Once DiaTech has completed analyses for the feasibility phase specimens and has confirmed that the sample acquisition, processing, transport, and assay interpretation are appropriate, we will proceed with the Demonstration Phase. During the Mesothelioma Demonstration Phase, 20 mesothelioma samples will be assayed and the results will be correlated with prior patient therapy, performance status, and extent of disease.

Official Title
-----------------
Mayo Clinic Validation of the MiCK Assay

Conditions
-----------------
Mesothelioma, Small Cell Lung Cancer, NSCLC

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 subjects diagnosed with mesothelioma and 10 diagnosed with any malignancy. Exclusion Criteria: patients that a sample cannot obtained for testing.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Mesothelioma<br> | |
| all cancer types<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response and survival |  | 1 year |
The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F&P trial nasal mask amongst Obstructive Sleep Apnea (OSA) patients.

Detailed Description
-----------------
Visit 1 will involve the participants consented in to the trial. Visit 2 will involve the participants being fitted with the F&P trial nasal mask for use in-home. The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit two. The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within 1 week of the beginning of the study.

Official Title
-----------------
The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Nasal CPAP mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (18+ years of age) Able to give consent Apnea hypopnea Index (AHI)≥ 5 on diagnostic night Prescribed PAP for OSA Existing nasal mask user Exclusion Criteria: Inability to give consent Patients who are in a coma or a decreased level of consciousness Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure) Commercial drivers who are investigated by New Zealand Transport Agency Current diagnosis of carbon dioxide (CO2) retention Pregnant or may think they are pregnant

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: Trial nasal Continuous Positive Airway Pressure (CPAP) mask<br>Trial nasal CPAP mask | Device: Nasal CPAP mask<br>* Investigative Nasal Mask to be used for OSA therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use | Subjective Questionnaire | 2 weeks | 
| Acceptability | Subjective Questionnaire | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective leak data | Data obtained from participant's device - Objective | 2 weeks |
Correction of Vitamin D Inadequacy in Nursing Home Residents

Study Overview
=================
Brief Summary
-----------------
Vitamin D inadequacy continues to be neglected in nursing home residents. We hypothesized that part of this neglect is due to absence of data documenting safe and effective ways to replete this inadequacy.

Detailed Description
-----------------
Vitamin D inadequacy continues to be neglected in nursing home residents. We hypothesized that part of this neglect is due to absence of data documenting safe and effective ways to replete this inadequacy. Subjects with low vitamin D concentrations are dosed with 50.000 IU three times a week for 25 hydroxy vitamin D, parathyroid hormone and bone turnover status. .

Official Title
-----------------
Effect of Vitamin D Supplementation on Skeletal and Overall Health of Nursing Home Residents

Conditions
-----------------
Hypovitaminosis D

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin D supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to walk Reside in nursing home for the 12 weeks of study Exclusion Criteria: Non-ambulatory residents

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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: vitamin D supplementation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Growth Hormone (GH) Deficiency & Insulin Like Growth Factor 1 (IGF-I)/ Insulin Like Growth Factor Binding Protein 3 (IGFBP-3) Ratio

Study Overview
=================
Brief Summary
-----------------
A 35-month cross-sectional observational study was conducted at an outpatient university hospital in Amman, Jordan. We obtained a comprehensive medical and laboratory evaluation for 134 short-statured children (64 boys and 70 girls, aged 4-16 years). Complete and partial growth hormone deficincy (GHD) were defined as peak forwth hormone (GH) response of 5 and 7 ng/ml [IRMA/ DiaSorin®], respectively in both clonidine stimulation and insulin tolerance tests. Serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 ratio were determined for all participants.

Official Title
-----------------
The Emerging Role of Serum IGF-I/IGFBP-3 Ratio in the Diagnosis of Children With Growth Hormone Deficiency

Conditions
-----------------
Diagnosis of GHD With IGF-I/IGFBP-3 Ratio

Intervention / Treatment
-----------------
* Other: IGF-1/IGFBP-3 ratio


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children presented to Jordan Univeristy Hospital (JUH) outpatient endocrinology clinic for the evaluation of short stature (SS) Exclusion Criteria: (i) their parents could not provide written consent for them; (ii) they were lost to follow up; (iii) they could not perform clonidine stimulation tests (CST) or insulin tolerance test (ITT) due to a medical contraindication (e.g. cardiac disorder, seizure disorder); (iv) they had received GH therapy in the past; (v) they were known to have pituitary diseases, hypothyroidism, hypogonadism or discovered to have panhypopituitarism or (vi) they have malnutrition, diabetes mellitus, liver disease, or other chronic illnesses.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 16 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 |
| --- | --- |
| IGF-I/ IGFBP-3 ratio group<br> | Other: IGF-1/IGFBP-3 ratio<br>* IGF-1/IGFBP-3 ratio for the diagnosis of GHD Vs. IGF-1, IGFBP-3 and IGF-1 & IGFBP-3 combination<br>|
| IGF-1 and IGFBP-3<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum IGF-1/IGFBP-3 ratio |  | 33 months |
Long Term Evaluation of Primary Congenital Glaucoma Management in Sohag University Hospital

Study Overview
=================
Brief Summary
-----------------
evaluation of primary congenital glaucoma management in sohag university hospital

Detailed Description
-----------------
long term evaluation of primary congenital glaucoma management in sohag university hospital

Official Title
-----------------
Long Term Evaluation of Primary Congenital Glaucoma Management In Sohag University Hospital

Conditions
-----------------
Primary Congenital Glaucoma

Intervention / Treatment
-----------------
* Other: Primary congenital glaucoma evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children operated more than 3 months Exclusion Criteria: other types of operated pediatric glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 3 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Primary congenital glaucoma evaluation|long term evaluation of primary congenital glaucoma management|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of patient with primary congenital glaucoma managed in sohag university hospital by surgical intervention,trabeculectomy and trabecultomy with mitomycin and ologen.follow up after management by measuring intra ocular pressure by Perkins. | retrospective study | 3years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary congenital glaucoma
Long-Term Safety Study of Vildagliptin in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 52-week clinical study is designed as an open label, long-term study aimed to evaluate the safety of vildagliptin in patients with type 2 diabetes.

Official Title
-----------------
A Multicenter, Open, Long Term Safety Study of 52 Weeks Treatment With Vildagliptin in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 2 diabetes Patients who have been placed on diet and exercise therapy without achieving target blood glucose levels Outpatients Exclusion Criteria: Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes Significant cardiovascular complications as defined by the protocol Significant diabetic complications as defined by the protocol Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events profile after 52 weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to endpoint on HbA1c at 52 weeks |  |  | 
| Change from baseline to endpoint on fasting plasma glucose at 52 weeks |  |  | 
| Change from baseline to endpoint in HOMA B at 52 weeks |  |  | 
| Change from baseline to endpoint in HOMA IR at 52 weeks |  |  | 
| Change from baseline to endpoint in body weight at 52 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, Vildagliptin, HbA1c
COMPARISON OF CORNEAL MEASUREMENTS IN NORMAL AND KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER

Study Overview
=================
Brief Summary
-----------------
The purpose of current study is to provide a comprehensive comparison of the reliability of corneal topographic measurements between Optovue AS- OCT and a combined Scheimpflug imaging using Wavelight Oculyzer Pentacam HR in normal and keratoconus eyes.

Official Title
-----------------
COMPARISON OF CORNEAL MEASUREMENTS IN NORMAL AND KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER

Conditions
-----------------
The Reliability of Corneal Topographic Measurements of Keratoconus Eyes

Intervention / Treatment
-----------------
* Diagnostic Test: corneal topography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: topography characteristic of keratoconus (skewed asymmetric bow-tie, inferior steep spot, etc.) and at least one clinical sign e.g., slit lamp findings of Munson's sign, Vogt's striae, Fleischer's ring, apical thinning, Rizutti's sign, etc. Exclusion Criteria: are advanced complications of keratoconus such as corneal scars or hydrops.

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: corneal topography|In all patients, TCT will be measured first by WaveLight® Oculyzer™II Pentacam HR and second by The Optovue AS-OCT .|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal measurments in KC CORNEAL MEASUREMENTS IN NORMAL AND KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER | In all patients, TCT will be measured first by WaveLight® Oculyzer™II Pentacam HR and second by The Optovue AS-OCT . KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER | we will recruit patients who meer the inclusion criteria during the study period januray-August 2020 |
Bone Marrow Collection in Healthy Volunteers (iCell)

Study Overview
=================
Brief Summary
-----------------
This is a observational study in which healthy found volunteers are recruited to donate 50 ml of bone marrow aspirate to enable preclinical studies to obtain proof of concept and safety of a bone marrow derived stem cell preparation named AMARCELL. The prepared AMARCELL is only for animal studies and after completion of the preclinical program, the intention of AMARCELL is to treat humans with a traumatic Spinal cord injury.

Detailed Description
-----------------
Coded anonymized patient data

Official Title
-----------------
Bone Marrow Collection in Healthy Volunteers

Conditions
-----------------
Spinal Cord Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men in the age range of 21-30 years and/or women in the age range of 21-30 years and taking birth control medication to prevent pregnancy Written informed consent Healthy as concluded by the answers given to questions in a short health questionnaire Exclusion Criteria: Pregnancy or lactation period Volunteers who are unable to comply with the rules of this project. Important is if the volunteer can not follow the schedule of the appointments. Abuse of alcohol, medicines or illicit drugs. Legally protected people

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of mononuclear cells include hematopoietic stem and progenitor cells in AMARCELL | Important is to have more than 2 million mononuclear cells (MNCs) include hematopoietic stem and progenitor cells in the end product AMARCELL | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of contamination with infectious agents especially bacteria and pseudomonas | The end product has to be sterile and will be tested for contamination. No culture after plating on growth medium (after 14 days) and no foreign non-human particles in the sample using Polymerase Chain Reaction techniques (after 6 hours). | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autologous Stem Cells, Spinal Cord Injury, Preclinical