linjc16/ctgov huggingface dataset:
Study of Blood Flow in Heart Muscle

Study Overview
=================
Brief Summary
-----------------
Blood flows to areas of the heart providing oxygen and fuel to the pumping muscle. Occasionally the arteries providing the fuel can become blocked. This occurs in coronary artery disease. Magnetic resonance imaging (MRI) can be used to evaluate the blood flow to different areas of the heart muscle. In this study magnetic resonance imaging will be compared to other diagnostic tests (radionucleotide perfusion studies) capable of measuring blood flow to heart muscle.

Detailed Description
-----------------
In this pilot study, magnetic resonance imaging (MRI) of myocardial enhancement during first passage of intravenously injected gadolinium contrast will be used to evaluate regional myocardial perfusion in patients with known or suspected coronary artery disease and hypertrophic cardiomyopathy. The MRI results will be compared with conventional radionuclide perfusion studies (ex. dipyridamole thallium). A clinically defined normal group will also be studied without radionuclide correlation.

Official Title
-----------------
Study of Myocardial Perfusion by MRI

Conditions
-----------------
Coronary Disease, Healthy, Hypertrophic Cardiomyopathy, Myocardial Ischemia

Intervention / Treatment
-----------------
* Procedure: Magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Ages 18 to 80. Either sex. Capable of giving informed consent. Group 1: Outpatients with known or suspected coronary artery disease with clinical indication for radionuclide perfusion imaging. Group 2: Patients with non-obstructive hypertrophic cardiomyopathy with clinical indication for radionuclide perfusion imaging. Group 3: Normal volunteers. Positive stress thallium or stress sestamibi (i.e., exercise, adenosine, dobutamine or dypiridamole) at the NIH. EXCLUSION CRITERIA: Pregnancy. Unstable angina. Uncontrolled hypertension (SBP greater than 185, DBP greater than 105). Recent myocardial infarction (less than 5 days). 2nd or 3rd degree heart block by ECG. Asthma, emphysema, renal failure, acute medical illness (fever, pneumonia, etc.) or anemia (hct less than 30). Cardiac pacemaker or implantable defibrillator, aneurysm clip, neural stimulator, any type of ear implant, metal in your eye, any implanted device (i.e. insulin pump, drug infusion device) or any metallic foreign body, shrapnel, or bullet.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Magnetic resonance imaging|nan|

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
-----------------
Gadolinium, Ischemia, Coronary Artery Disease, Hypertrophic Cardiomyopathy, Dipyridamole
Phase 1b Study of Omega DUROS® in Patients With Chronic Hepatitis C Who Relapsed After Prior Treatment

Study Overview
=================
Brief Summary
-----------------
Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon subcutaneously at a constant rate for 90 days. This study is being performed to evaluate the safety and antiviral effects of omega interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects with chronic Hepatitis C genotype 1.

Official Title
-----------------
Phase Ib Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Omega DUROS® and Ribavirin in Subjects With Chronic Hepatitis C Previously Treated With Pegylated Interferon and Ribavirin

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: Omega DUROS device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Hepatitis C with HCV genotype 1 infection Relapse following an end of treatment response after treatment with a pegylated interferon and ribavirin. Exclusion Criteria: Presence or history of non-HCV chronic liver disease Treatment with any interferon subsequent to the relapse with pegylated interferon-alpha and ribavirin Decompensated liver disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: 1<br>Omega DUROS: Dose 25 | Drug: Omega DUROS device<br>* Omega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks<br>|
| Experimental: 2<br>Omega DUROS: Dose 50 | Drug: Omega DUROS device<br>* Omega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | Week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapse, HCV, Hepatitis C, Interferon, Ribavirin
CMT-07-08: The PROstate Bed Evaluation Study

Study Overview
=================
Brief Summary
-----------------
This is an observational study to collect placement and tracking data for patients who have the Calypso transponders implanted into the peri-prostatic tissue.

Detailed Description
-----------------
Use of Real-time tracking using Calypso Electromagnetic Beacons in the prostatic bed of patients receiving radiotherapy following radical prostatectomy.

Official Title
-----------------
The Probe Study - The PROstate Bed Evaluation - A Study to Record the Implant Experience, Transponder Stability and Tracking Data of the Calypso 4D Localization Study in the Prostate Bed

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: Observation of transponder stability


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with recurrence of prostate cancer following radical prostatectomy for prostate adenocarcinoma Patients with initially undetectable PSA following prostatectomy for prostate adenocarcinoma with subsequent PSA relapse Patients being planned for radiation therapy Patient is being planned for implant with Calypso Transponders in the prostate bed No evidence of distant metastases Age ≥ 18 years Informed consent Exclusion Criteria: The patient has received other investigational therapy in the last 60 days The patient has previously been implanted with permanent beacon transponders The patient has a prosthetic implant in the pelvic region that contain metal or conductive materials The patient has any other medical or other condition that would, in the investigator's opinion, make them a poor candidate for the study

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| stability of Beacons in prostatic bed<br>Patients implanted with the Calypso transponders following radical prostatectomy for prostate cancer will be followed for observation of transponder stability. | Other: Observation of transponder stability<br>* Observation of transponder stability and placement in the prostatic bed following radical prostatectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect data on the process of implanting the Calypso Transponder in the prostate bed following radical prostatectomy |  | Immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the stability of the Calypso transponder in the prostate bed |  | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate, prostate bed, periprostatic
Gender Differences and Age Related Differences in Emergency Department Admission

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to learn about difference related to age and gender in patients admitted to emergency department.

Detailed Description
-----------------
Objectives: Medicine is progressively becoming aware of the clinical difference among patients who present different age, gender, and comorbidities. Our goal is to examine how often different groups of patients access the Emergency Department and for which causes, as well as their different hospitalization and death rates. Materials and methods: The investigators will collect and analyze data from all patients evaluated at the emergency department of Fondazione Policlinico Agostino Gemelli and Istituto Clinico Humanitas di Milano from January 2014 to December 2023, the sample obtained will be divided into four groups: younger than 50 years old, 50-65 years old, 66.75 years old, older than 75; each of these groups is divided between males, females and people who do not identify with either of those genders

Official Title
-----------------
Gender Differences and Age Related Differences in Emergency Department Admission

Conditions
-----------------
Emergencies, Age Problem, Gender

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 y Admitted to emergency department Exclusion Criteria: Age under 18 y

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 |
| --- | --- | --- |
| Death | Death | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay | length of stay | 180 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sex, gender, age, emergency department
MK0524A Phase IIb Study (0524A-011)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
Part A: This study will determine that MK0524 is well tolerated and does not effect lipids and blood glucose when given alone. Part B: Determine dose ranges for MK0524 and MK0524 plus Niaspan(R) on the effects of lipids and blood glucose.

Official Title
-----------------
Part A: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of MK0524 Compared to Placebo Part B: A Dose-Ranging Study to Evaluate the Tolerability of MK0524 and Its Effects on Niacin-Induced Flushing in Lipid Clinic Patients

Conditions
-----------------
Flushing

Intervention / Treatment
-----------------
* Drug: Comparator: niacin / Duration of Treatment: 17 Weeks
* Drug: MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks
* Drug: Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, 18 to 70 years of age for whom treatment with Niacin would be appropriate but who are not taking > 50mg at screening Must be willing to complete electronic diary Exclusion Criteria: Subject is having menopausal hot flashes and/or receiving hormone replacement therapy (HRT) You have a history of cancer, gout, peptic ulcers, diabetes, liver, heart disease or high blood pressure or you are HIV positive You consume more than 14 alcoholic drinks per week or more than 2 drinks per day

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Comparator: niacin / Duration of Treatment: 17 Weeks|nan|
|Drug: MK0524A, niacin (+) laropiprant / Duration of Treatment: 17 Weeks|nan|
|Drug: Comparator: placebo (unspecified) / Duration of Treatment: 17 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of MK0524A on lipids and blood glucose |  | 17 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the dose for limiting flushing symptoms induced by NIASPAN (R) |  | 17 Weeks |
Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by Rituximab

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the midterm clinical evaluation, biological parameters and immune reconstitution after Rituximab treatment for Pemphigus.

Official Title
-----------------
EVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMAB

Conditions
-----------------
Pemphigus

Intervention / Treatment
-----------------
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18 consentment patient treated with Rituximab and included in clinical trial n°2002/020/HP - NCT00213512 Treatment of Patients Presenting Pemphigus With Anti CD20 (Mabthera). Exclusion Criteria: age < 18 no consentment

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rituximab|375mg/m2|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of relapse after 5 years of treatment | Primary outcome measure is the evaluation of Rate of relapse after 5 years of treatment by rituximab for patient with pemphigus. The relapse is defined by the reappearance of mucous or cutaneous érosives lésions proved by histology and by direct immunofluorescence | five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pemphigus, Mabthéra (R), B lymphocytes, desmogleines
Effect of Insulin on Wound Healing-A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
A randomized controlled trial examining the effect of insulin on wound healing in both diabetics and non diabetic patients in a local health center in Bahrain.

Detailed Description
-----------------
This is a double blinded RCT comparing the effect of insulin on wound healing in both diabetics and non diabetics. The study will run in primary care setting in Bahrain. The aim of this study is to heal wound in an innovative way. and the Objective: to evaluate the effect of topical insulin administration on wound healing. All adult patients with skin wounds attending primary health care center will be included in the study. Patients with acute and chronic wounds of the upper and lower extremities will be eligible to participate.

Official Title
-----------------
Effect of Insulin on Wound Healing- A Randomized Controlled Trial

Conditions
-----------------
Wound Heal

Intervention / Treatment
-----------------
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with Texas 1 and 2 wound criteria Exclusion Criteria: Texas 3 and 4 wound criteria -

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Before starting the therapeutic procedure, all wounds will be fully washed with normal saline. Group A patients will receive 10 units (0.1 mL) of regular insulin (manufactured by novo nordisk) in solution with 1 cc of normal saline 0.9% for each 10 cm of wound. The solution will be sprayed on the wound surface with an insulin syringe needle, once daily. The patients in this arm will receive conventional therapy. | Drug: Insulin<br>* Adding insulin to conventional wound treatment<br>* Other names: Regular Insulin;|
| Placebo Comparator: Control<br>Before starting the therapeutic procedure, all wounds will be fully washed with normal saline Group B patients will receive conventional topical application without insulin | Drug: Insulin<br>* Adding insulin to conventional wound treatment<br>* Other names: Regular Insulin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area of wound healing | Rate of wound healing will be calculated as the difference between the primary and final wound area in mm as a function of healing time (in days) and reported as mm/day. | 4 months |
Does Deficiency in Vitamin D Induced Hypercoagulation or Thrombin Generation

Study Overview
=================
Brief Summary
-----------------
Working hypothesis and aims: The aim of our study is to investigate whether vitamin D deficiency could cause increased thrombin generation and a hypercoagulable state healthy volunteers. Methods: In total 400 healthy volunteers are planned for inclusion in this trial. After signing an informed consent two blood samples will be obtained from each participant. Expected results: invastigator expect to find that volunteers with vitamin D deficiency will have thrombin generation curve compatible with hypercoagulable state and returning to normal after treatment with vitamin D

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Drug: Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 healthy naive to drug treatment - Exclusion Criteria: no exc criteria -

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 |
| --- | --- |
| healthy voulnters<br> | Drug: Vitamin D<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the correlation between vitamin D levels and endogenous thrombin potential | one blood test | 3 month |
Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis

Study Overview
=================
Brief Summary
-----------------
After successful screening, first the investigators first treat patients of severe alcoholic hepatitis with steroids for 7 days. Patients who are found to be unresponsive as per Lille's score [>0.45] would be randomized into either placebo group or G-CSF group. Responders to steroids will continue on steroids for 28 days followed by 2 weeks of tapering. Non responders will be randomized to receive G-CSF for 28days.

Official Title
-----------------
Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis. - A Double Blind Randomized Control Trial.

Conditions
-----------------
Severe Alcoholic Hepatitis

Intervention / Treatment
-----------------
* Drug: G-CSF
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Severe alcoholic hepatitis patients [Maddrey's score > 32] aged between 18 to 65 years. Exclusion Criteria: Presence of active infections Acute GI bleed Hepatorenal syndrome Patient unwilling DF>120 Autoimmune hepatitis Hepatitis B, Hepatitis C, HIV cases Pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo would be given s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses) | Drug: G-CSF<br>* G-CSF would be given at a dose of 5 microgram/kg daily for 5 days followed by once in 3 days for a total of 12 doses.<br>|
| Experimental: G-CSF<br>G-CSF would be given at a dose of 5 microgram/kg daily for 5 days followed by once in 3 days for a total of 12 doses. | Drug: Placebo<br>* Placebo would be given s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Survival of subjects in both group |  | 4 weeks and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Child's score in steroid unresponsive patients with severe alcoholic hepatitis patients | Change in child score at 4 week and 12 weeks compared to baseline in both groups. | 4 weeks and 12 weeks | 
| Improvement in MELD score in steroid unresponsive patients with severe alcoholic hepatitis patients | Change in MELD score at 4 week and 12 weeks compared to baseline in both groups | 4 weeks and 12 weeks |