linjc16/ctgov huggingface dataset:
Cell-based Therapy for the Treatment of Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Endothelial progenitor cells derived from and delivered to the renal vasculature may be stimulated to initiate differentiation programs during episodes of injury. It is hypothesized that endothelial progenitor cells from the kidney can transition to a phenotype that promotes endothelial repair.

Detailed Description
-----------------
This is an interventional study involving patients that have a diagnosis of chronic kidney disease. Patients will have at least stage 3 chronic kidney disease stage or greater. Kidney-derived endothelial progenitor cells will have been obtained using associated protocols that are currently approved by the Partners Human Research Committee.

Official Title
-----------------
Cell-based Therapy for the Treatment of Kidney Disease

Conditions
-----------------
Kidney Diseases

Intervention / Treatment
-----------------
* Biological: endothelial progenitor cell


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled patients will have endothelial progenitor cells previously acquired. Exclusion Criteria: Patients without previously acquired endothelial progenitor cells will be excluded.

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
Intervention Model: Single Group Assignment
Interventional Model Description: Open label single arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients will be given autologous endothelial progenitor cells | Biological: endothelial progenitor cell<br>* Kidney-derived endothelial progenitor cells will be delivered percutaneously to the kidney blood supply.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of progenitor cell delivery | Serum creatinine will be measured after cell delivery | 180 days |
Reproducibility of Computed Tomography

Study Overview
=================
Brief Summary
-----------------
Thus, the aim of this study was to evaluate the reproducibility of the Computed Tomograph scan three-dimensional reconstruction method for the measurement of the TB pleural effusion volume in clinically stable patients.

Detailed Description
-----------------
Speed, accuracy, and precision in the quantification of pleural effusion are of critical importance as it determines whether or not thoracocentesis should be carried out and which technique should be employed for such a procedure. This study evaluates the precision of thoracic computed tomography with three-dimensional (3D) rebuilding in determining the volume of tuberculosis pleural effusion.Twenty patients with pleural effusion were screened and invited to take part in the study. Each patient underwent two computed tomography scans, before and after one month of treatment for tuberculosis, a total of 40 exams. These were evaluated by two expert radiologists. In conclusion, the quantification of the pleural effusion volume by using thoracic CT with volumetric three-dimensional reconstruction is a highly reproducible method.

Official Title
-----------------
Evaluation of the Reproducibility of Computed Tomography for the Measurement of Tuberculosis Pleural Effusion

Conditions
-----------------
Tuberculosis, Pleural Effusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 18 years with a confirmed diagnosis of pleural TB effusion . Signed out an informed consent term Exclusion Criteria: Patients with human immunodeficiency virus (HIV).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tuberculosis, Pleural Effusion, Computed Tomography
Prevention of High Altitude Pulmonary Edema

Study Overview
=================
Brief Summary
-----------------
A double-blind placebo controlled study To compare the effect of tadalafil and dexamethasone versus placebo on Ppa and pulmonary edema formation in subjects susceptible to HAPE. To investigate the effect of dexamethasone on alveolar fluid clearance, as assessed by measurement of the nasal potential difference, and prevention of HAPE. To investigate the effect of the tadalafil and dexamethasone versus placebo on the dynamic CBF autoregulation properties and on the development of AMS in HAPE susceptible subjects.

Official Title
-----------------
A Randomized Controlled Trial of the Effects of Tadalafil and Dexamethasone Versus Placebo on Pulmonary Edema Formation and Cerebral Blood Flow Autoregulation in High Altitude Newcomers With a Previous History of High Altitude Pulmonary Edema

Conditions
-----------------
High Altitude Pulmonary Edema

Intervention / Treatment
-----------------
* Drug: dexamethasone 8 mg bid
* Drug: tadalafil 10mg bid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one previous episode of high altitude pulmonary edema Exclusion Criteria: pulmonary arterial hypertension congenital heart disease any chronic lung disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dexamethasone 8 mg bid|nan|
|Drug: tadalafil 10mg bid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevention of high altitude pulmonary edema |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of acute mountain sickness |  |  |
Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography

Study Overview
=================
Brief Summary
-----------------
hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and considered to be the traditional and the gold standard in the assessment of the patency of the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study reported the patients complained of moderate to severe pain during the procedure. It is reported that some patients undergoing hysterosalpingography was more stressful and anxiety and effect on pain scores.

Official Title
-----------------
Randomized Clinical Trial of Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography

Conditions
-----------------
Pain Relief

Intervention / Treatment
-----------------
* Drug: oral hyoscine butyl bromide tablets plus lidocaine cream
* Drug: oral placebo tablets plus placebo cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • The infertile women who indicated for HSG Exclusion Criteria: contraindications to Hyoscine or lidocaine known sensitivity to contrast media abnormal uterine bleeding genital tract infection suspected pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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 |
| --- | --- |
| Active Comparator: Group A<br>oral hyoscine butyl bromide tablets plus lidocaine cream | Drug: oral hyoscine butyl bromide tablets plus lidocaine cream<br>* patients will take oral hyoscine butyl bromide 30 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before the procedure<br>|
| Placebo Comparator: Group B<br>oral placebo tablets plus placebo cream | Drug: oral placebo tablets plus placebo cream<br>* patients will take oral placebo 30 minutes before the procedure plus placebo cream placed into their cervix immediately before the procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain score during HSG |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain score after HSG |  | 30 minutes | 
| rate of side effects |  | 30 minutes |
Comparison of Chitosan and Carboxymethylcellulose Silver Dressings on Burn Wounds in Pediatric and Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective, randomized, comparative multi-center study is to compare the effective management of two silver-based dressings in managing exudative wounds in first and second degree burns.

Official Title
-----------------
A Multi-Center, Randomized, Comparison Study of a Chitosan (Opticell Ag+) Silver Dressing and a Sodium Carboxymethylcellulose (Aquacel® Ag+) Silver Dressing on Burn Wounds in Pediatrics and Adults Subjects

Conditions
-----------------
Bandages

Intervention / Treatment
-----------------
* Device: Opticell Ag+
* Device: Aquacel Ag+


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatient status at the site Written consent obtained from the subject Burn injury must have been incurred within 36 hours prior to enrollment. Burn injury must be of superficial partial thickness, mid-dermal partial thickness, or a combination of the two depths Burn injury must exceed 3% total body surface area. Exclusion Criteria: Subject is pregnant. Bone fractures. Inhalation-related trauma. Sensitive and/or allergic to materials containing silver. Burn injury exceeds 40% total body surface area. Burn injury diagnosis indicates deep partial or full thickness wounds. Burn a result of electrical/chemical injury or frostbite. An active agent, such as a topical antimicrobial or an enzymatic debriding agent was previously used to treat the burn injury in question.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- |
| Active Comparator: Opticell Ag+<br>Absorbent, antibacterial, barrier dressing | Device: Opticell Ag+<br> <br> |
| Active Comparator: Aquacel Ag+<br>Absorbent, antibacterial, barrier dressing | Device: Aquacel Ag+<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Infection Rates |  | Up to 21 days of use | 
| Days required for wound healing |  | Up to 21 days of use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Levels during Dressing Removal | Categorical scale of pain reported by Subject | Up to 21 days |
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)

Study Overview
=================
Brief Summary
-----------------
This exploratory, first-in-man, phase 0 study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of NP-59 ([18F]FNP-59) to image the adrenal gland in healthy normal subjects. The researchers believe that [18F]FNP-59 would greatly improve the imaging characteristics, by providing a PET imaging cholesterol analogue with significantly improved radiation dosimetry.

Detailed Description
-----------------
Following the results of radiation dosimetry from this study then next steps will be taken for groups 2 & 3 using hormone manipulation.

Official Title
-----------------
Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)

Conditions
-----------------
Radiotracer, Hypertension, Cholesterol

Intervention / Treatment
-----------------
* Drug: FNP-59


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes Exclusion Criteria: Pregnancy Unable to do imaging Body weight greater than 400 lbs (181 Kg) Prisoners are not eligible Subjects unable to provide own consent are not eligible Current use of steroids, Oral contraceptives (OCP), spironolactone, estrogen, androgen, progesterone, Angiotensin-converting enzyme (ACE inhibitors)/ Angiotensin II receptor blockers (ARBs), or supplements that are hormone analogues. Known adrenal pathology

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>These subjects, 6 planned (3 male, 3 female), will be to obtain normal tissue distribution of [18F]NP-59 and confirm calculated radiation dosimetry and optimal uptake time. | Drug: FNP-59<br>* FNP-59, a radiotracer, is administered for PET/CT scans.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation | SUV will be reported. Both maximal and average SUVs will be calculated | Day 0 |
Clinical Application of Sensimed Triggerfish Sensor (TS) With Wireless Signal Transmission for Continuous Intraocular Pressure Measurement

Study Overview
=================
Brief Summary
-----------------
The study objective is to investigate the clinical applicability of continuous IOP measurement using TS with radio transmission over 24 hours. Trial with medical device

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: Triggerfish


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Clinical diagnosis of glaucoma Exclusion criteria: Other opticus neuropathy than glaucoma Corneal abnormalities (e.g. scaring) Dry eye 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Triggerfish|The Triggerfish is a contact lens with an embedded sensor to track changes in intraocular pressure during a period of 24 hours.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Trial on Profermin and Fresubin in Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
This study aim to investigate the effect of Profermin versus Fresubin in the dietetic treatment of active ulcerative colitis.

Official Title
-----------------
A Randomized Trial on Profermin and Fresubin for Dietetic Treatment of Active Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Other: Profermin
* Other: Fresubin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active ulcerative colitis (SCCAI =>5 and <=11) Access to Internet Exclusion Criteria: Stoma or intestinal resections Recent changes in UC medication Treatment with antibiotics Diabetes Celiac disease Lactose malabsorption

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Profermin<br> | Other: Profermin<br>* Medical Food (food for special medical purposes)<br>|
| Active Comparator: Fresubin<br> | Other: Fresubin<br>* Medical food (food for special medical purposes)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development in Simple Clinical Colitis Activity Index (SCCAI) score | Clinical significant difference (>1.5) in course of SCCAI score between the two intervention groups | 8 and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in SCCAI score | Proportion of patients with a reduction in SCCAI above 1.5, 3.0 and 4.5 | 8 and 16 weeks | 
| Clinical remission | Proportion of patients in clinical remission (SCCAI=<2.5) | 8 and 16 weeks | 
| Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 20 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBD, UC, Profermin, Fresubin, Probiotics, Dietetic
The UTHealth Medical-Legal Partnership: Improving Health by Addressing Health-Harming Legal Needs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the acceptability, feasibility, and preliminary effectiveness of the UTHealth medical-legal partnerships (MLP) against usual care.

Official Title
-----------------
The UTHealth Medical-Legal Partnership: Improving Health by Addressing Health-Harming Legal Needs

Conditions
-----------------
Social Determinants of Health

Intervention / Treatment
-----------------
* Other: Access to the Medical-Legal Partnership Group
* Other: Access to social worker and a community worker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English- or Spanish- speaking screen positive for health-harming legal needs (HHLNs) Exclusion Criteria: Those unable or unwilling to consent to legal services

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 |
| --- | --- |
| Medical-Legal Partnership Group<br>The Medical-Legal Partnership Group are lawyers in clinics who address health-harming legal needs. This group will also have access to access to a social worker and a community worker. | Other: Access to the Medical-Legal Partnership Group<br>* The Medical-Legal Partnership Group are lawyers in clinics who address health-harming legal needs.<br>Other: Access to social worker and a community worker<br>* Access to social worker and a community worker, but no systematic process for addressing health-harming legal needs.<br>|
| Usual Care<br>Access to a social worker and a community worker, but no systematic process for addressing health-harming legal needs. | Other: Access to social worker and a community worker<br>* Access to social worker and a community worker, but no systematic process for addressing health-harming legal needs.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who had an emergency department visit |  | 6 months |
A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)

Study Overview
=================
Brief Summary
-----------------
This study is the US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).

Detailed Description
-----------------
User Performance - Assess Lay User fingertip test results obtained on the new BGMS compared to a validated method (YSI 2300 STAT PLUS glucose analyzer results) according to FDA Guidance 2016 section VI.C. Assess System Use of the new BGMS, as relevant to self-testing technique, with reference to the Owner's Booklet.

Official Title
-----------------
US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a New Blood Glucose Monitoring System.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: New BGMS (US)


Participation Criteria
=================
Eligibility Criteria
-----------------
Summary of inclusion criteria: Subject is at least 12 years old. Informed Consent. Subject has a current diagnosis of type 1 or type 2 diabetes mellitus. Subject reads and understands English. Subject is currently performing unassisted self-monitoring of blood glucose (SMBG) OR naive to SMBG for a 10% sub-group. Summary of exclusion criteria: Conflict of interest. Technical expertise.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood Glucose monitoring System (BGMS)<br>Intervention: Blood Glucose monitoring Systems (BGMS): Results obtained from the new BGMS for UP are compared to a reference instrument (YSI 2300) | Device: New BGMS (US)<br>* New blood glucose monitoring system / In vitro diagnostic device (IVDD)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Performance ( UP) | User Performance evaluation (referred to as Method Comparison / User Evaluation in FDA Guidance 2016): Lay User accuracy of BGMS by comparison of meter blood glucose results to a laboratory reference instrument. | < 30 minutes | 
| System Use Evaluation | System usability: Lay user system use evaluation (as relevant to fingertip self-testing) by study personnel observation and completion of a scoring questionnaire. | < 30 minutes |