linjc16/ctgov huggingface dataset:
Intracoronary Stem Cells in Large Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Despite the widespread use of effective reperfusion therapies, the patients presenting late with large myocardial infarction have poor outcomes. The aim of the study was to investigate the safety and efficacy of intracoronary injection of autologous bone marrow-derived mononuclear cells (BMNCs) in patients with large myocardial infarction

Detailed Description
-----------------
In the current era, up to 30% of patients with ST-segment elevation myocardial infarction, usually those presenting late, show ongoing left ventricular (LV) remodeling and poor clinical outcome despite primary percutaneous coronary intervention (PCI). Cardiac transfer of bone marrow-derived stem and progenitor cells has been investigated as an adjunctive therapy to promote regeneration of infarcted myocardium. Therefore, we designed a multicenter, randomized study to test the safety and efficacy of intracoronary injection of autologous BMNCs in patients with large acute anterior myocardial infarction and late presentation, who were treated with successful primary PCI.

Official Title
-----------------
Intracoronary Stem Cells in Large Myocardial Infarction

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: Intracoronary infusion of autologous bone-marrow derived stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with the first ST-segment elevation acute anterior myocardial infarction due to occlusion of the proximal left anterior ascending coronary artery (LAD), who will underwent successful primary stented PCI. Patients are eligible if they have primary PCI from 4 to 12 hours after symptoms onset and show reduced LV ejection fraction ≤ 45% with at least 3 akinetic segments in the LAD perfusion territory at echocardiogram performed 24 hours after PCI. Exclusion Criteria: Exclusion criteria are age ≥ 80 years, cardiogenic shock (Killip IV), multivessel coronary artery disease, serious renal or hepatic disease, blood cells disorders, documented cancer or terminal illness.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

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

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

| Intervention/Treatment |
| --- |
|Procedure: Intracoronary infusion of autologous bone-marrow derived stem cells|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
ALA on Glycemic Control in T2DM Participants

Study Overview
=================
Brief Summary
-----------------
With the emerging worldwide epidemic of type 2 diabetes, dietary recommendations to improve diabetes management have been emphasized in the scientific community. Particular attention has been drawn to various benefits of replacing saturated fatty acids with unsaturated fatty acids. Alpha-linolenic acid, the only omega-3 fatty acid that is from plant sources, has been suggested by animal and cell studies to play a beneficial role in regulating blood glucose levels. However, human studies have been more inconsistent with their findings. The focus of this project is to investigate the evidence in the context of ALA and blood glucose parameters in participants with type 2 diabetes by conducting a systematic review and meta-analysis of randomized controlled trials.

Official Title
-----------------
The Effect of Alpha-Linolenic Acid on Glycemic Control in Participants With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Dietary Supplement: Alpha-Linolenic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Controlled, randomized, clinical trials Trials greater than one month Focusing on ALA and T2DM participants Viable endpoint data Exclusion Criteria: Non-human studies Non-random treatment allocation Less than 1 month Lack of suitable control Lack of endpoint data
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Alpha-Linolenic Acid|Meta-Analysis of Randomized Controlled Trials|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fructosamine |  | 1 month | 
| Fasting Blood Glucose |  | 1 month | 
| Fasting Blood Insulin |  | 1 month | 
| Glycated Albumin |  | 1 month | 
| HOMA- IR |  | 1 month |
NIV Mask Assessment of Usability and Performance

Study Overview
=================
Brief Summary
-----------------
Assessment of usability, perceived comfort and performance of a NIV mask in the hospital environment.

Detailed Description
-----------------
50 participants admitted for NIV therapy will have the investigation mask fitted. The doctors and nurses assigned to the participants care will complete a subjective evaluation on how the mask performs compared to the standard of care mask. Some therapy settings and demographics will be recorded.

Official Title
-----------------
Usability and Performance of a Non-invasive Ventilation Mask. A Prospective Cohort.

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Device: Investigational Non Invasive Ventilation Mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted and indicated for non invasive ventilation therapy Assessed for capacity to consent and consent process documented Fits the investigation mask Aged 18 year or older Exclusion Criteria: - Contraindicated for non invasive ventilation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigation Mask<br>Non invasive ventilation mask | Device: Investigational Non Invasive Ventilation Mask<br>* Oronasal non invasive ventilation mask<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived mask performance | Three point visual analogue scale on preference 1 = Worse, 2 = Same, 3 = Better | During the intervention |
Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious Uveitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.

Official Title
-----------------
A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan- Uveitis

Conditions
-----------------
Uveitis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Dose 1 gevokizumab
* Drug: Dose 2 gevokizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye Active uveitic disease in at least one eye Currently on one of the following stable treatment regimens for uveitis: oral corticosteroids; systemic immunosuppressive medication; a combination of oral corticosteroids with at least one systemic immunosuppressive medication Effective contraceptive measures Exclusion Criteria: Infectious uveitis and masquerade syndromes Isolated anterior uveitis Contraindication to mydriatics History of allergic or anaphylactic reactions to monoclonal antibodies Active tuberculosis disease History of recurrent infection or predisposition to infection; active ocular infection Pregnant or nursing women 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Solution for subcutaneous injection<br>|
| Experimental: Dose 1 gevokizumab<br> | Drug: Dose 1 gevokizumab<br>* Solution for subcutaneous injection<br>|
| Experimental: Dose 2 gevokizumab<br> | Drug: Dose 2 gevokizumab<br>* Solution for subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of responders at Day 56 | A response is defined as an improvement of the study eye without deterioration in the contralateral eye. | Day 56 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uveitis, Non-infectious Uveitis, Intermediate Uveitis, Posterior Uveitis, Panuveitis
The Value of HBA in the Evaluation of Idiopathic Infertility

Study Overview
=================
Brief Summary
-----------------
We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor

Detailed Description
-----------------
We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor We would like to determine if patients with abnormal HBA binding have decreased IVF outcome: decreases clinical pregnancy rate, implantation rate, and increased miscarriage rate

Official Title
-----------------
The Value of Hyaluronic Binding Assays (HBA) in the Evaluation of Idiopathic Infertility

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

Intervention / Treatment
-----------------
* Other: HBA binding assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: . All groups will include females under 40 years of age undergoing 1st IVF cycle 3 groups Abnormal Semen Analysis (sperm count <10 million/ml and /or rapid progressive motility < 50 %, WHO morphology <30%) normal HSG , normal ovarian reserve testing and ovulation testing Unexplained infertility- normal ovarian reserve testing and ovulation testing (FSH< 10, AMH>1.0) Normal ovulatory cycles, normal WHO semen analysis. Normal tubes on HSG or Laparoscopy Tubal infertility as assessed by HSG or laparoscopy Exclusion Criteria: women over 40, prior failed IVF

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hylauronin binding assay<br>HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF. | Other: HBA binding assay<br>* HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In each of these groups we will assess presence of HBA bound sperm |  | immediate at time of preforming HBA test |
Low Dose Lung CT Scan for Quantitative Analysis in ARDS Patients

Study Overview
=================
Brief Summary
-----------------
We aimed to assess the accuracy of visual and quantitative analysis performed on low radiation dose lung CT scan (30-60 mAs)compared with that performed on standard radiation dose lung CT scan (110 mAs), in ARDS patients. If the results in computing lung recruitment will be similar, we will be able to use Low Dose CT scan for monitoring of the evolution of the disease in ARDS patients.

Conditions
-----------------
Acute Respiratory Distress Syndrome (ARDS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Respiratory Distress Syndrome CT scan performed for clinical purposes Exclusion Criteria: Age < 18 years hemodynamic instability

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 |
| --- | --- | --- |
| Difference between Standard and Low Dose lung CT scan in visual and quantitative analysis | We measured lung recruitment with visual and quantitative analysis both on standard and low dose CT scan. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Respiratory Distress Syndrome (ARDS)
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding Due to Trauma

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The purpose of this study is to evaluate the treatment of Recombinant Faction VIIa in Patients with Severe Bleeding Due to Trauma Please note that this trial and trial F7TRAUMA-1711 (NCT00184548) have been merged.

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®/ NiaStase®) in the Treatment of Refractory Bleeding in Severely Injured Trauma Patients

Conditions
-----------------
Acquired Bleeding Disorder, Trauma

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Trauma injury (blunt and/or penetrating) with evidence of active torso hemorrhage refectory to standard treatment

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

| Intervention/Treatment |
| --- |
|Drug: activated recombinant human factor VII|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality and Morbidity |  | through day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  |  | 
| Hospital-free days |  |  | 
| Number of transfusion units |  |  | 
| Days free of renal replacement therapy |  |  | 
| ICU-free days |  |  | 
| Days free of ventilator support |  |  |
A Study of Megestrol Acetate in HIV-Infected Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if megestrol acetate is safe and effective in treating HIV-infected children with failure to thrive (FTT).

Detailed Description
-----------------
The study design is randomized, double-blind, placebo-controlled for 12 weeks with open-label drug offered after week 12.

Official Title
-----------------
Megestrol Acetate For Failure To Thrive In Pediatric HIV

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Megestrol acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Documented HIV infection. Failure to thrive as defined by: crossing 2 percentile lines on standard weight for age curves over time or less than 5% percentile weight for age and falling from the curve or loss of 10% of baseline body weight. Resistant to oral nutritional supplementation (i.e., FTT despite a minimum 1-month trial of high-calorie oral supplements). Free of significant acute illness (mild upper respiratory tract infections allowed). Patients with chronic diarrhea allowed provided malabsorption and gastrointestinal infection ruled out. Exclusion Criteria Co-existing Condition: Patients with the following symptoms are excluded: Gastrointestinal infection or malabsorption. Significant acute illness. Any identified, untreated cause for failure to thrive other than underlying HIV infection. Medical contraindications to megestrol acetate. Patients with any of the following prior conditions or symptoms are excluded: Medical contraindications to megestrol acetate including a history of poorly-controlled hypertension, deep venous thrombosis, or heart failure. History of prior megestrol acetate therapy in the past six months.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Megestrol acetate|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
-----------------
Placebos, Appetite Stimulants, Megestrol Acetate, Failure to Thrive
A Randomized Clinical Trial Assessing Smoking Cessation Interventions In Dental Clinic Smokers

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to see if giving patients information about how smoking affects oral health will help them quit smoking. What we learn from this study will help researchers find new ways to help smokers.

Official Title
-----------------
A Randomized Clinical Trial Assessing Smoking Cessation Interventions In Dental Clinic Smokers

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: Standard Care only
* Behavioral: Dental Hygienist provided counseling + Brief Questionnaire
* Behavioral: Dental Hygienist provided counseling with personalized risk communication + Brief Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient seeking routine dental care at NYU College of Dentistry and meets medical clearance for routine care Active smokers (active smoking as self-reported regular use of at least 10 cigarettes per day) Able to provide a telephone number or collateral contact information where they can be reached over the subsequent 12 months Fluent in English or Spanish Exclusion Criteria: History of mouth or throat cancer

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 |
| --- | --- |
| 1<br>Standard Care | Behavioral: Standard Care only<br>* Dentist Provided Standard Care, 3-month follow-up assessment, Clinic visit salivary cotinine test, 12-month follow-up assessment, Clinic visit salivary cotinine test<br>|
| 2<br>Standard Care with Hygienist Counseling | Behavioral: Dental Hygienist provided counseling + Brief Questionnaire<br>* Dental Hygienist provided + Brief Questionnaire, 3-month follow-up assessment,Clinic visit salivary cotinine test, 12-month follow-up, Clinic visit salivary cotinine test assessment<br>|
| 3<br>Standard Care with Hygienist Counseling & Personalized Risk Communication | Behavioral: Dental Hygienist provided counseling with personalized risk communication + Brief Questionnaire<br>* Dental Hygienist provided counseling with personalized risk communication + Brief Questionnaire, 3-month follow-up assessment, Clinic visit salivary cotinine test, 12-month follow-up assessment, Clinic visit salivary cotinine test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of varied smoking cessation interventions |  | 1 year |
Spinal Cord Evoked Potentials as a Tool to Investigate Sensorimotor Processing

Study Overview
=================
Brief Summary
-----------------
The study first aim is to investigate the relationship between different patterns of electrode stimulation and peripheral sensory stimulation and spinal cord-evoked potentials to optimize spinal cord stimulation parameters . The second aim of the study is to investigate the role of the spinal cord in some aspects of cognitive-sensory-motor processing, specifically the presence of top-down attentional effects on the sensory analysis of an external stimulus at the spinal cord level. The study will be performed on patients that will be implanted with a spinal epidural electrode because of chronic intractable pain. From these electrodes, spinal cord evoked potentials (SCEPs) will be recorded.

Official Title
-----------------
Spinal Cord Evoked Potentials in Candidates for Dorsal Column Stimulation

Conditions
-----------------
Studying Spinal Cord Evoked Potentials in Patients With Intractable Pain.

Intervention / Treatment
-----------------
* Behavioral: Recording spinal cord evoked potentials


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18 - 70 Candidates for spinal cord stimulation Epidural electrode at the the level of the cervical or thoracic spine. Exclusion Criteria: Generalized sensory deficit interfering with the recording of spinal cord evoked potentials

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Candidates for dorsal column stimulation<br> | Behavioral: Recording spinal cord evoked potentials<br>* Recording spinal cord evoked potentials from patients suffering from intractable pain in whom epidural electrodes have already been implanted<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |