linjc16/ctgov huggingface dataset:
Reducing Suicidal Ideation Through Treatment of Nightmares-Post Traumatic Stress Disorder (PTSD)

Study Overview
=================
Brief Summary
-----------------
Patients with PTSD, and frequent nightmares, and mild-moderate suicidal ideation, who are already taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) will be randomized to either prazosin or placebo. The investigators hypothesize that patients receiving prazosin will have a greater reduction in suicidal ideation.

Official Title
-----------------
Reducing Suicidal Ideation Through Treatment of Nightmares-PTSD

Conditions
-----------------
Suicidal Ideation, Post Traumatic Stress Disorder, Nightmares

Intervention / Treatment
-----------------
* Drug: Prazosin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PTSD Frequent nightmares Suicidality Exclusion Criteria: Schizophrenia Bipolar Substance abuse

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo pill | Drug: Placebo<br> <br> |
| Experimental: prazosin<br>prazosin pill | Drug: Prazosin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Score for Scale for Suicide Ideation | There will be data on the Scale for Suicide Ideation collected at the end of each week of treatment up to 8 weeks. Our apriori primary outcome is the change score in Scale for Suicide Ideation from baseline to the last observation. This is a self report scale, with 19 items which measure present suicidality, each scored 0-2. The total scale has a range from 0-38, with higher scores being worse | change score from baseline to last observation, up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disturbing Dreams and Nightmare Severity Index | This is a self report scale, with 5 items, producing a total score with a range from 0-37. Higher scores are worse. A score greater than 10 is considered to indicate a clinically relevant problem with nightmares and/or bad dreams | 8 weeks | 
| Insomnia Severity Index | This is a self report scale, with 7 items scored 0-4, producing a total score range 0-28. Higher scores are worse Score 0-7 is interpreted as no insomnia problem 8-14 subclinical insomnia 15-21 moderate insomnia 22-28 severe insomnia | 8 weeks |
Ubiquinol Treatment in Patients With Heart Failure and Preserved Ejection Fraction

Study Overview
=================
Brief Summary
-----------------
There are no studies specifically examining the effects of coenzyme Q (CoQ) treatment on echocardiographic indices of diastolic function in elderly patients with heart failure with preserved ejection fraction (HFPEF). In previous studies the only echocardiographic parameters studied were ejection fraction (EF) and chamber size. The objective of the proposed current study is to examine the effect of 16 weeks of ubiquinol therapy on diastolic function assessed by echocardiography in patients over the age of 50 with a clinical diagnosis of HFPEF. Ubiquinol (Kaneka Pharma), the reduced form of CoQ will be utilized for this study as it has been shown to have superior bioavailability when compared to oxidized CoQ.

Official Title
-----------------
The Effect of Ubiquinol Treatment on Cardiac Function in Patients With Heart Failure With Preserved Ejection Fraction

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

Intervention / Treatment
-----------------
* Drug: ubiquinol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Typical signs and symptoms of congestive heart failure (CHF) (New York Association Class 2-4). Normal ejection fraction on echocardiography (EF ≥50%). Evidence of diastolic dysfunction on non-invasive imaging (E:e' > 15 or e:e' > 8 with other measures of diastolic dysfunction such as e/a < 0.5 with elevated deceleration time or left atrial volume index > 40 cc/m2 or presence of elevated left ventricular mass index or elevated pulmonary pressures). Stable medical therapy for 4 weeks prior to randomization Exclusion Criteria: Chronic atrial fibrillation. Acute coronary syndrome or coronary revascularization within 60 days. Clinically significant valvular disease. Known infiltrative cardiomyopathy (e.g. amyloidosis), hypertrophic cardiomyopathy or chronic pericardial disease. Inability/refusal to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo three times daily | Drug: Placebo<br>* Sugar pill three times daily<br>|
| Active Comparator: Active<br>Pills of 100 mg ubiquinol three times daily | Drug: ubiquinol<br>* Ubiquinol three times daily<br>* Other names: coenzyme Q10;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diastolic function as assessed by mitral valve inflow and tissue Doppler velocities on echocardiography |  | 4 months | 
| NT-pro brain natriuretic peptide (NT-proBNP) serum levels (pg/ml) |  | 4 months |
Personalized Phage Treatment in Covid-19 Patients With Bacterial Co-Infections Microbials for Pneumonia or Bacteremia/Septicemia

Study Overview
=================
Brief Summary
-----------------
Phage Treatment in Covid-19 Patients with Bacterial Co-Infections

Detailed Description
-----------------
The treatment approach will be to make phage therapy available to institutions who care for Covid-19 patients with bacterial co-infections due to A. baumannii, P. aeruginosa or S. aureus. Patient bacterial isolates will be tested to determine phage susceptibility prior to and during phage therapy. The primary objectives are to determine the feasibility of developing, producing and providing a personalized intravenous phage for Covid-19 patients who have pneumonia, bacteremia or septicemia due to A. baumannii, P. aeruginosa or S. aureus and to evaluate the safety of intravenous phage in Covid-19 patients along with anti-microbial treatment for pneumonia, bacteremia or septicemia due to A. baumannii, P. aeruginosa or S. aureus.

Official Title
-----------------
Expanded Access Study of Phage Treatment in Covid-19 Patients on Anti-Microbials for Pneumonia or Bacteremia/Septicemia Due to A. Baumannii, P. Aeruginosa or S. Aureus

Conditions
-----------------
Covid19, Bacteremia, Septicemia, Acinetobacter Baumannii Infection, Pseudomonas Aeruginosa Infection, Staph Aureus Infection

Intervention / Treatment
-----------------
* Other: Phage Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Covid-19 patients with pneumonia or bacteremia/septicemia who have culture-confirmed bacterial co-infection with A. baumannii, P. aeruginosa or S. aureus. Patient provided informed and signed consent. Exclusion Criteria: Patient eligible for another APT sponsored trial. Patient participating in another clinical trial at the same time or patients < 4 weeks from participating in an alternative investigational protocol/study Patient with known allergy to infusion of phage products Patients with a history of Meningitis or encephalitis at time of study entry, Primary immune deficiency disease or tuberculosis or Stroke, transient ischemic attack (TIA), or untreated deep vein thrombosis.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Phage Therapy|Personalized intravenous phage therapy in Covid-19 patients along with anti-microbial treatment for pneumonia, bacteremia or septicemia due to A. baumannii, P. aeruginosa or S. aureus.|

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
-----------------
Covid19, Bacteriophage, Phage, Bacteremia, Septicemia, Acinetobacter, baumannii, Pseudomonas, Aeruginosa, Infection, Staph, Aureus
Microchimeric Cell Tranfer From Mother to Child - Pilo Study

Study Overview
=================
Brief Summary
-----------------
Microchimeric cells are known to be transferred from mother to child through the placenta. However it has been postulated that they could also be transferred through breastfeeding. This study is designed to analyse lymphoid and digestive tract tissues (tonsils and appendixes) in male infants (or young adults) to research microchimeric female cells and try to correlate the frequency and localisation of said cells to the breastfeeding status during early infancy

Official Title
-----------------
Identifying and Quantifying Microchimeric Maternal Cells in Young Males, Potentially Acquired Through Breastfeeding - A Pilot Study

Conditions
-----------------
Breastfeeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: age 1-16 years (at the time of surgery) male known breastfeeding status in infancy Exclusion criteria: premature birth (before 37 weeks) history of blood transfusion history of bone marrow transplant history of organ transplant patient known to have a twin known gonosomal

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 16 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 |
| --- | --- |
| patients for tonsils<br>40 patients for tonsils | |
| patients for appendixes<br>40 patients for appendixes) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify microchimeric cells of maternal origin in lymphoid | To identify microchimeric cells of maternal origin in lymphoid in young males cytogenetic FISH staining, coupled with MS-PCR, to identify microchimeric cells. | day 1 | 
| To identify microchimeric cells of maternal origin in digestive tissues | To identify microchimeric cells of maternal origin in digestive tissues in young males cytogenetic FISH staining, coupled with MS-PCR, to identify microchimeric cells. | day 1 | 
| to determine Quantifying the microchimeric cells | Quantifying the microchimeric cells : Cell quantification will be assessed through FISH staining (automated cell counting) and qPCR | day 1 | 
| to determine locating the cells in tissues | locating the cells in tissues : Appendix histology slides will be analysed after FISH staining to locate the microchimeric cells | day 1 | 
| to determine trying to find a correlation between breastfeeding status | trying to find a correlation between breastfeeding status : Microchimeric cell quantification will be confronted to the breastfeeding status in infancy (collected during patient inclusion) to validate a correlation | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microchimeric, Microchimerism
Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure.

Detailed Description
-----------------
Patients enrolled received a device with cardiac resynchronization therapy (CRT) and defibrillation. Patients were randomized to CRT on or off for up to six months and evaluated for mortality, hospitalization, and functional outcomes including exercise capacity, quality of life, symptomatic status, and echocardiographic analysis.

Official Title
-----------------
VENTAK CHF/CONTAK CD Biventricular Pacing Study

Conditions
-----------------
Heart Failure, Congestive, Ventricular Fibrillation, Tachycardia, Ventricular

Intervention / Treatment
-----------------
* Device: Cardiac Resynchronization Therapy with Defibrillation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic heart failure Left ventricular ejection fraction <= 35% QRS width >= 120 ms Indicated for an implantable cardioverter defibrillator Exclusion Criteria: Indicated for a pacemaker Atrial tachyarrhythmias
Sexes Eligible for Study
-----------------
All

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 |
| --- |
|Device: Cardiac Resynchronization Therapy with Defibrillation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak VO2 |  |  | 
| NYHA Class |  |  | 
| Six minute walk distance |  |  | 
| Quality of life |  |  | 
| Echocardiographic measures |  |  |
Retrospective Analysis on Distal Humerus Fractures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate preoperative objective measurements for distal humerus ORIF patients and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.

Official Title
-----------------
Distal Humerus Fractures: A Data Analysis on Patients Undergoing Open Reduction and Internal Fixation for the Surgical Management of Distal Humeral Fractures

Conditions
-----------------
Distal Humerus Fracture

Intervention / Treatment
-----------------
* Other: ORIF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking >18 years of age Open reduction internal fixation surgical management of a distal humeral fracture performed by principal investigator at St. Elizabeth Healthcare Exclusion Criteria: Non-English speaking <18 years of age

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

| Intervention/Treatment |
| --- |
|Other: ORIF|open reduction internal fixation of the distal humerus|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total operative time | minutes | preoperative to up to 8 years postoperative | 
| amount of blood loss | mls | preoperative to up to 8 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Outcomes | American Shoulder and Elbow Surgeon score to measure shoulder function and pain. Scale of 0-100, 100 being the best possible score | preoperative to up to 8 years postoperative | 
| Patient Outcomes | Simple Shoulder Test score to measure shoulder function. Scale from 0-12, 12 being the most functional. | preoperative to up to 8 years postoperative |
Diagnosis of Active and Latent TB Infection With IFN-y Assays in African Children

Study Overview
=================
Brief Summary
-----------------
Study based in Southern Ethiopia Purpose - to explore if children in contact with adults with TB have positive acute reactants such as IFN-y and other cytokine responses; if these responses discriminate between high and low risk of disease progression and whether these could be incorporated into improved diagnostic approaches.

Detailed Description
-----------------
The study follows children in contact with TB. Those with positive TST will be offered chemoprophylaxis and all children will be followed for 2 years to describe IFN-y responses over time, identify symptoms of active TB and if these symptoms are associated with IFN-y and other cytokine responses. Children with suspicion of TB attending health centres will also be investigated using routine diagnostic tests and IFN-y and other cytokines responses to evaluate if the latter could be used in improved diagnostic approaches.

Official Title
-----------------
Diagnosis of Active and Latent TB Infection With IFN-y Assays in African Children

Conditions
-----------------
Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Children - 1 to 14 years old in contact with adults with smear positive TB Or: - Children with suspicion of TB admitted to the hospital for investigations Exclusion Criteria: - Residency > 10 Km from recruitment center Or: - Patient severely to undergo diagnostic procedures.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 14 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
-----------------
TB, latent, infection, Ethiopia
The Results of Ahmed Valve Operations

Study Overview
=================
Brief Summary
-----------------
Glaucoma drainage devices are usually placed in the superior quadrants. The superotemporal quadrant is usually the site of choice. However, when the upper fornix is scarred and especially when conjunctiva is two fibrotic to enable adequate coverage of tube with a scleral or other patch graft, some surgeons place the tube in one of inferior quadrants.

Detailed Description
-----------------
Glaucoma drainage devices are usually placed in the superior quadrants. The superotemporal quadrant is usually the site of choice. However, when the upper fornix is scarred and especially when conjunctiva is two fibrotic to enable adequate coverage of tube with a scleral or other patch graft, some surgeons place the tube in one of inferior quadrants. In the present study we will compare the outcome and complicatons of both the superior and the inferior approach for inserting Ahmed Valve implants.

Official Title
-----------------
A Comparison Between Superior and Inferior Ahmed Glaucoma Valve Implantation: Surgical Success and Complications

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

Intervention / Treatment
-----------------
* Procedure: 1) Intraocular pressure 2) visual acuity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients at the ages of 20-85 on the date of the surgery The indication for the surgery was: uncontrolled glaucoma with maximally tolerated medical therapy who did not or were not expected to respond to other surgical procedures than seton surgery. Visual acuity of, at least, 20/800 before the operation. Regular post operative follow ups, for at least 1 year. Patients after corneal transplantation for whom the indication of valve implantation was uncontrolled glaucoma. Exclusion Criteria: A previous seton surgery in the operated eye Uveitic glaucoma patients or history of uveitis in the operated or in the fellow eye. Any inflammatory or ocular surface disease that could affect the healing of the conjunctiva after the surgery ( e.g: OCP) Strabismus or complains of diplopia prior to the seton surgery. Past history of retinal detachment surgery with scleral buckle in the operated eye Past history of endophthalmitis in the operated eye.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 1) Intraocular pressure 2) visual acuity|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
-----------------
Seton surgery, glaucoma, Ahmed valve, intraocular pressure