linjc16/ctgov huggingface dataset:
Gene Expression Outcomes in Interventions for Substance Using HIV+ Minority Men

Study Overview
=================
Brief Summary
-----------------
This is a pilot study of a new 9-session individually delivered cognitive behavioral intervention targeting sexual minority stress. In this study, 40 HIV+ men sexual minority men will be recruited for the study then will be randomly assigned to either the new 9 session intervention or a writing task condition.

Official Title
-----------------
Gene Expression Outcomes in Interventions for Substance Using HIV+ Minority Men

Conditions
-----------------
Human Immunodeficiency Virus Infection, Inflammation

Intervention / Treatment
-----------------
* Behavioral: AWARENESS for Sexual Minorities
* Behavioral: Writing tasks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide evidence or documentation of HIV positive status (e.g. a letter of diagnosis or medication bottles with matched photo ID) Be English speaking Be able to consent Sexual activity with a man in the 3 years prior to initial contact or identification as gay or bisexual Not currently be enrolled in formal substance abuse treatment Report at least one occasion of drinking 5 or more drinks or of using an illicit substance in the previous 3 months, but not meet criteria for a severe substance use disorder. Exclusion Criteria: Presence of a severe substance use disorder Presence of current symptoms consistent with schizophrenia or bipolar disorder, which would indicate that an intervention targeting these symptoms would be more appropriate.

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

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

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 |
| --- | --- |
| Experimental: AWARENESS for sexual minorities<br>Group receives new CBT-based intervention | Behavioral: AWARENESS for Sexual Minorities<br>* 9 session, individually delivered, cognitive behavioral intervention focused on modifying sexual minority stress responses to reduce the impact of sexual minority stress experiences.<br>|
| Active Comparator: Writing tasks<br>Group receives writing-based sessions | Behavioral: Writing tasks<br>* Writing sessions to explore daily activities.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gene expression | Gene expression related to inflammation measured in blood | Baseline,  9 weeks (at conclusion of intervention), 4 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Substance Use | Substance Use measured through Alcohol Smoking and Substance Involvement Screening Test (ASSIST) | Baseline,  9 weeks (at conclusion of intervention), 4 month follow-up |
Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The investigators prospectively investigate the differences between contact-force guided pulmonary vein isolation (PVI) and conventional pulmonary vein isolation in patients with paroxysmal atrial fibrillation (PAF) with respect to adenosine guided unmasking of dormant conduction, procedural and clinical outcome.

Official Title
-----------------
Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

Conditions
-----------------
Improving Outcome After Pulmonary Vein Isolation

Intervention / Treatment
-----------------
* Other: Pulmonary vein isolation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients (>=18 und < 80 years) with symptomatic paroxysmal AF At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III). Oral anticoagulation with phenprocoumone, warfarine or DOAKs for at least 4 weeks prior to ablation with weekly documented INR > 2.. Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone. Exclusion Criteria: Left atrial thrombus Contraindications for oral anticoagulation or adenosin

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 |
| --- | --- |
| Other: Conventional Pulmonary vein isolation<br>Conventional pulmonary vein isolation was gained by using an irrigated tip ablation catheter | Other: Pulmonary vein isolation<br> <br> |
| Other: Contact force pulmonary vein isolation<br>Contact force was meassured by using the SMART-Touch ablation catheter (Biosense-Webster®) | Other: Pulmonary vein isolation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of reconnected pulmonary vein after ablation and a waíting period of 20min |  | 20min after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first documented recurrence of atrial fibrillation |  | 12 month | 
| Complications due to ablation |  | 30 days | 
| Number of reconnected pulmonary veins |  | 12 month |
Predictive Model for Postoperative Mortality

Study Overview
=================
Brief Summary
-----------------
Surgery has risk of morbidity and mortality. Risk factors include: patient factors; surgical factors; and anesthetic factors. The risk is much higher in emergency cases. The study of relevant risk factors can lead to improvement in patient management and reduction in mortality.

Detailed Description
-----------------
Objective: To identify risk factors for postoperative mortality within 3 days in adult patients undergoing emergency surgery and construct a predictive model. Methods: This will be a retrospective, exploratory and analytical study. All medical records of adult patients undergoing emergency surgery between January 2013 to December 2014 will be used to analyze for relevant risk factors using binary logistic regression analysis. A predictive model to predict postoperative morbidity within 3 days will be constructed.

Official Title
-----------------
Predictive Model for Postoperative Mortality in Adult Emergency Surgical Patients Under General Anesthesia

Conditions
-----------------
Postoperative Complications

Intervention / Treatment
-----------------
* Procedure: Emergency surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emergency surgery Age => 18 years Exclusion Criteria: Caesarean section Incomplete medical record

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postoperative mortality within 3 days<br>Group 1: Patients undergoing emergency surgery with postoperative mortality within 3 days Group 2: Patients undergoing emergency surgery without postoperative mortality within 3 days | Procedure: Emergency surgery<br>* Patients undergoing emergency surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative mortality within 3 days | Patient die postoperatively within 3 day3 | through study completion, an average of 1 week |
Glioblastoma Platelet Activation Study

Study Overview
=================
Brief Summary
-----------------
Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (M2) phenotype. Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.

Detailed Description
-----------------
Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (M2) phenotype. Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.

Conditions
-----------------
Glioblastoma, Circulating Platelet-monocyte Conjugates

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MR-morphological suspicion for glioblastoma informed consent Exclusion Criteria: no informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| patients<br>glioblastoma patients | |
| controls<br>healthy controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean P-selectine expression in all platelets |  | 01/ 2016 - 10/ 2016 | 
| Mean CD63 expression in all platelets |  | 01/ 2016 - 10/ 2016 | 
| Mean CD40 Expression in all platelets |  | 01/ 2016 - 10/ 2016 | 
| Mean platelet-monocyte-conjugate formation in the monocyte population |  | 01/ 2016 - 10/ 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelet activation
Ultrashort Cognitive Behavioral Intervention for Tokophobia- A Prospective Randomized Single Blinded Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Women in their 3rd trimester, represent a unique segment of the tokophobic population. In these cases help is needed within a very short and limited period of time. To date, no specific treatment targets this population in order to ameliorate the anxiety and to provide these women and their newborns with better obstetric and psychiatric outcomes. The present study investigates an accessible individual two session intervention conducted by midwives skilled in CBT (cognitive behavioral therapy) . This intervention is designed to enable stronger emotional regulation and increase of their capacity to accept unexpected changes during labor and feelings of control. The investigators expect this psychological adjustment to lead to a better course of delivery, less interventions including caesarian sections, and subjective birth experience.

Official Title
-----------------
Ultrashort Cognitive Behavioral Intervention for Tokophobia- A Prospective Randomized Single Blinded Controlled Trial

Conditions
-----------------
Specific Phobia

Intervention / Treatment
-----------------
* Behavioral: CBT
* Other: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hebrew speaking pregnant women week 32 + 0 to 37 + 0 fulfilling the criteria for a specific phobia diagnosed by SCID (Structured Clinical Interview for the Diagnostic) in accordance with DSM-V (Diagnostic and Statistical Manual) and the Fear of Vaginal Delivery Questionnaire (FDQ). Exclusion criteria: Women who suffer from a psychotic disorder, PTSD or suicidal ideation High risk pregnancies Alcoholism or drug abuse and dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group<br>will receive 2 sessions of 90 minutes each of a cognitive behavioral protocol for the treatment of Tokophobia administered by a CBT trained midwife. | Behavioral: CBT<br>* novel cognitive behavioral protocol for the treatment of tokophobia<br>|
| Sham Comparator: Control group<br>will receive 2 sessions of a delivery preparation course (practice as usual). | Other: Sham<br>* standard birth preparation sessions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy-Related Anxiety Questionnaire | a widely used instrument to assess and identify pregnancy-specific anxiety in women | In the end of second session of intervention- up to 4 weeks from screening |
Dosing of Levetiracetam (Keppra) in Neonates

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady state drug levels of levetiracetam in neonates.

Official Title
-----------------
Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm Neonates

Conditions
-----------------
Seizures

Intervention / Treatment
-----------------
* Drug: levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age ≥ 32 weeks Postnatal age ≤ 30 days Birth weight ≥ 2000 grams Admitted to the Neonatal Intensive Care Unit at Cincinnati Children's Hospital Clinical or electrographic seizures of any etiology Seizures or seizure prophylaxis requiring treatment with levetiracetam Parental consent obtained Exclusion Criteria: Infants with renal insufficiency indicated by serum creatinine > 2.0 at any time Infants who have previously received levetiracetam Parents refuse consent Attending physician does not wish the infant to be enrolled in the study Infants who are currently receiving an investigational drug

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 30 Days

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: levetiracetam|50 mg/kg single loading dose of IV levetiracetam|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Profile | 3 levels for levetiracetam and its metabolite L057 will be drawn: at 5-20 minutes after the dose, 1-2 hours after the dose, and 6-10 hours after the dose. In infants who remain on maintenance doses of the medication, a steady state level will be drawn 4-7 days after the loading dose. Outcome reported is clearance. The median maximum clearance rate was measured in each participant and determined by evaluating the levels of levetiracetam at each time point using MW Pharm. | 5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
seizures, neonate, levetiracetam, Epilepsy, central nervous system diseases, anticonvulsants
Laparoscopic Ventral Mesh Rectopexy Versus Delorme's Operation in Management of Complete Rectal Prolapse

Study Overview
=================
Brief Summary
-----------------
A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's procedure in treatment of complete rectal prolapse to ass both efficacy and complications

Detailed Description
-----------------
A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's procedure in treatment of complete rectal prolapse to ass both efficacy and complications. Follow up is scheduled for 18 months to evaluate recurrence, continence state and complications

Official Title
-----------------
Laparoscopic Ventral Mesh Rectopexy Versus Delorme's Operation in Management of Complete Rectal Prolapse

Conditions
-----------------
Complete Rectal Prolapse

Intervention / Treatment
-----------------
* Procedure: Laparoscopic ventral mesh Rectopexy
* Procedure: Delorme's procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with complete rectal prolapse Exclusion Criteria: patients who underwent previous surgery for complete rectal prolapse patients unfit for surgery patients with associated colorectal diseases or pathology

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic ventral mesh Rectopexy<br>Fixation of the rectum to the sacrum using laparoscopy and mesh | Procedure: Laparoscopic ventral mesh Rectopexy<br>* Laparoscopic fixation of rectum to sacral promontory using mesh<br>|
| Active Comparator: delorme's procedure<br>excision of excess rectal mucosa under spinal anesthesia then plication of the rectal muscles with vicryl 2/0 sutures | Procedure: Delorme's procedure<br>* Transanal excision of rectal mucosa and plication of muscle layer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of the condition | Measured by counting the number of patients with recurrence of rectal prolapse | 18 month |
The Place of Men in Arrested Pregnancies

Study Overview
=================
Brief Summary
-----------------
An terminated pregnancy is defined as the cessation of cardiac activity before 14 weeks of amenorrhea. This early interruption of gestation can be induced by pathological, traumatic or idiopathic causes. In any case, it remains a physically and psychologically trying event for the woman, the couple as well as for the man. Indeed, the loss of this embryo, which measures only a few millimeters, corresponds to the loss of a child for the triad: woman, man, couple. The termination of this pregnancy is experienced as a bereavement for the future parents. The stopped pregnancy has always been a taboo in the society. The proof being that it was not until the 1980s that this was considered mourning and its psychological consequences were studied. Following these studies, psychological follow-ups are democratized and are thus offered to women. However, when is it men? The investigators have always put the woman at the center of the care process. Which is legitimate. However, the man is often seen as the person who influences the woman. This default categorization marginalizes the man who would like to be an actor in the care of his partner. In fact, men are increasingly asking to support women in their gynecological care procedures. Unfortunately, for lack of measures put in place. The men are more than abandoned.

Official Title
-----------------
The Place of Men in Arrested Pregnancies

Conditions
-----------------
Arrested Pregnancies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age ≥18 years old male Speaking French The progenitor of the pregnancy and whose partner is affected by an aborted pregnancy Exclusion criteria: Subject having expressed opposition to participating in the study Subject under safeguard of justice Subject under guardianship or guardianship Subject under guardianship, curatorship or safeguard of justice

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the role of the men's place during an aborted pregnancy of their partners |  | up to 1 month post-arrested pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arrested pregnancies, Cardiac Arrest
Single and Multiple Ascending Doses of AZD1981 in Japan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study safety, tolerability and pharmacokinetics of AZD1981 in healthy Japanese subjects

Official Title
-----------------
A Randomised, Placebo-Controlled, Double-Blind, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of AZD1981 in Healthy Male Japanese and Caucasian Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD1981
* Drug: AZD1981
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Japanese and Caucasian males Exclusion Criteria: Other clinically relevant disease or disorders

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD1981<br>* Oral tablet, 250 mg single dose<br>|
| Experimental: 2<br> | Drug: AZD1981<br>* Suspension, 15, 75, 1000 and 2000 mg<br>|
| Placebo Comparator: 3<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | All the time | 
| Plasma drug concentration |  | Every hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical chemistry |  | day 1 and 9 |