linjc16/ctgov huggingface dataset:
Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if there is a difference between an antibiotic, trimethoprim-sulfamethoxazole versus placebo in healing outcomes of soft tissue abscesses following incision and drainage.

Official Title
-----------------
Trimethoprim-sulfamethoxazole Versus Placebo in the Treatment of Cutaneous Abscesses in the Emergency Department

Conditions
-----------------
Abscess

Intervention / Treatment
-----------------
* Drug: Trimethoprim-sulfamethoxazole
* Drug: Sugar pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 3 months to 17 years Single, localized soft tissue abscesses requiring incision and drainage with purulent material obtained Diameter of the abscess less than 5cm as measured by the treating physician Exclusion Criteria: Signs of systemic illness or ill-appearing, as determined by the treating physician Admission to the hospital following treatment in the Emergency Department Known sulfa allergy Immunocompromised patients Soft tissue abscesses involving the perineum (labia, scrotum, penis, perirectal) Previous antibiotic use (for any reason) in the past seven days Non-English speaking patients and families

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 17 Years

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

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

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 |
| --- | --- |
| Experimental: Trimethoprim-sulfamethaxazole<br>Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients) | Drug: Trimethoprim-sulfamethoxazole<br>* 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)<br>* Other names: Bactrim;|
| Placebo Comparator: Sugar pill<br>Incision and drainage of the abscess and treatment with oral placebo (100 patients) | Drug: Sugar pill<br>* 10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Outcomes After Use With Trimethoprim-sulfamethaxazole |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abscess, outcomes, antibiotics, incision and drainage, skin abscess
Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma

Study Overview
=================
Brief Summary
-----------------
The Objective was to Develop a Cost-Effectiveness study that compares Ciclesonide and Beclomethasone in pediatric asthma control.

Detailed Description
-----------------
Cost-effectiveness study, of cohorts, observational, analytic, prospective, from health institution perspective. Based on published data related to percentage of patients free of crisis for both molecules, it was estimated that the sample size to detect significant differences between the two alternatives was 20 patients per alternative. Medical records of 94 patients with diagnosis of uncontrolled asthma were included, aged between 6 and 15 years, 47 received Beclomethasone randomly, and 47 received Ciclesonide randomly, treatment physician was blind related to this assignation, both cohorts were followed for 6 months, and primary effectiveness variable was defined as number of patients free of crisis with each alternative. Cost generating variables were defined as medication use, and hospital stay. Decision analysis was based on a decision tree.

Official Title
-----------------
Phase 4 Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma in a Hospital in Bogotá

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Beclomethasone
* Drug: Ciclesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with uncontrolled asthma diagnosis Patients with only one controller medication Exclusion Criteria: Patients without lung infection Patients without antibiotic use

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 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 |
| --- | --- |
| Active Comparator: Ciclesonide<br> | Drug: Ciclesonide<br>* 80 to 160 mcg per day for 6 months<br>|
| Placebo Comparator: Beclomethasone<br> | Drug: Beclomethasone<br>* 200 to 400 mcg per day for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness measured as number of patients free of asthmatic crisis with each molecule during the study period | Effectiveness was assesed counting number of patients that were free of asthmatic crisis for each steroid ciclesonide and beclomethasone during 6 months of treatment | 6 months |
PPI Versus Placebo in Severe Functional Heartburn

Study Overview
=================
Brief Summary
-----------------
Proton Pump Inhibitors are no better than placebo in relieving GERD symptoms in patients with functional Heartburn.

Official Title
-----------------
PPI Versus Placebo in Severe Functional Heartburn

Conditions
-----------------
GERD

Intervention / Treatment
-----------------
* Drug: PPI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heartburn twice a week for at least 2 years. Normal EGD and 24hr pH study. Exclusion Criteria: <18yrs of age,pregnant, unable or unwilling to give consent, allergic to PPI, previous gastric or esophageal surgery, past hx of erosive GERD, unwilling or unable to stop acid suppression meds

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: no label study<br>1 | Drug: PPI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in GERD controll PPI vs Placebo based on a validated GERD questionnarir. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, PPI, Functional heartburn
Automatic Recognition of Freezing of Gait Episodes

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that mathematical algorithm can identify freezing episodes based on data obtained from accelerometer.

Detailed Description
-----------------
The subjects will walk with an accelerometer. The acceleration traces will be online analyzed, and if freezing episode is recognized, an auditory cue will be heard.

Official Title
-----------------
Online Automatic Recognition of Freezing of Gait Episodes

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Device: Auditory cue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Parkinsons disease prone to freezing of gait Exclusion Criteria: Patients who are not able to ambulate independently

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- |
| PD+FOG<br>Patients with Parkinson's disease prone to freezing | Device: Auditory cue<br>* When device recognizes automatically freezing episode it will generate auditory cue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Palladium-103 Seed Implant and Single Daily Dosing of Uroxatral Vs. Twice Daily Dosing of Flomax- A 3 Month Retrospective Efficacy Analysis

Study Overview
=================
Brief Summary
-----------------
In the past ten years, newer drugs with more selective affinity for the alpha-receptor have been introduced. Alfuzosin (Uroxatral) and Tamulosin(Flomax are two second generation alpha-blockers. In the course of our clinical proctice, both drugs have been used routinely. This retrospective comparison is intended to be a priliminary comparison of their effectiveness and side effects.

Official Title
-----------------
Palladium-103 Seed Implant and Single Daily Dosing of Uroxatral Vs Twice Daily Dosing of Flomax-A 3 Month Retrospective Efficacy Analysis

Conditions
-----------------
Prostate Cancer Patients Undergoing External Radiation and Seed Implantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males age 45-80 years Diagnosis of prostate cancer Status post IMRT and Palladium-103 seed implantation and initiated alpha blocker therapy with alfuzosin10mg daily or tamulosin 0.4mg bid at time of seed implantation Baseline AUA score< or =12 May be on antiandrogenand/or alpha reductase therapy Patients receiving IMRT followed by Palladium-103 Brachytherapy implantation as the primary therapy for prostate cancer with curatives intent - Exclusion Criteria: History of insulin-dependent diabetes Uncontrolled hypertention History of symptomtic hypotension (including syncope and dizziness) Pre-existing obstructive uropathy based on history of BPH and or Acute Urinary Retention Pre-existing prostatitis either continuous or intermittent Concurrent use of any other anticholinergics previous or concurrent usage of LHRH agonist

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 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 |
| --- | --- | --- |
Bupivicain vs Bupivicain Plus Dexamethasone in ESP Block for Post-op Analgesia

Study Overview
=================
Brief Summary
-----------------
Thoracotomy is a very painful procedure. Different treatment modalities are being utilized for post-thoracotomy analgesia including I/V NSAID, Opoids and Neuropathic medications. Other techniques commonly utilized include Thoracic epidural, Paravertebral block; but both are associated with significant failure rate and other complications. Ultrasound guided Erector Spinae Plane block is a new regional anesthesia technique that provides analgesia at multidermatomal levels acriss the posterior, lateral and anterior thoracic walls. The rational of my study is that it is a novel technique and studies with bupivicain alone are present but no study was found with bupivicain plus dexamethasone.

Official Title
-----------------
Comparison of Bupivicain Alone With Bupivicain Plus Dexamethasone in Erector Spinae Plane Block For Post-Operative Analgesia After Thoracotomy

Conditions
-----------------
Post Operative Pain

Intervention / Treatment
-----------------
* Drug: inj bupivicain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-60years ASA I-III Patients undergoing elective thoracotomies Exclusion Criteria: Refusal of Patient Coagulation disorders Known Allergy to Local Anesthetics Infection at the site of injection Pregnant females Morbid Obesity(BMI>40kg/m2) Psychiatric illness Diabetic Patients.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Group B.<br>group B will receive Inj Bupivicain only in Erector Spinae Plane Block. | Drug: inj bupivicain<br>* In goup B 30ml of inj. bupivicaine only will be given in Erector Spinae Plane Block and In Group D inj Bupivicain plus inj dexamethasone will be given<br>* Other names: inj bupivicain plus dexamethasone;|
| Active Comparator: Group D<br>group D will receive Inj Bupivicain plus Dexamethasone in Erector Spinae Plane Block. | Drug: inj bupivicain<br>* In goup B 30ml of inj. bupivicaine only will be given in Erector Spinae Plane Block and In Group D inj Bupivicain plus inj dexamethasone will be given<br>* Other names: inj bupivicain plus dexamethasone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain scores | Visual Analogue Score is utilized to assess the postoperative pain | 36 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erector Spinae Plane Block, Thoracotomy, Ultrasound
SMART - Systems Medicine of Heart Failure

Study Overview
=================
Brief Summary
-----------------
The onset and course of heart failure (HF) is triggered by a complex regulatory network that includes stressors (pressure overload by individual anatomic hemodynamic settings), intrinsic (genes), environmental (regulating epigenetics), and modifying factors (such as hor-mones and the immune system). SMART aims to establish individualized strategies for the prevention and management of HF by early detection of the physiological, genomic, proteo-mic and hemodynamic mechanisms that lead from onecommon cause of ventricular dysfunction (pressure overload) to maladaptive remodelling and irreversible HF. To cope with the complexity of HF, SMART will interrelate models describing the interplay between ge-nome, proteome and cell function, regulating hormones, tissue composition and hemody-namic whole organ function up to a whole body description of a patient and patient cohorts. The ultimate goal is to demonstrate proof-of-concept tools for predicting disease evolution and efficacy of treatment in a given patient. To achieve this task SMART will apply A modelling framework that couples multi-scale mechanistic models with in-depth genome/proteome, cell physiology and whole organ (biomechanical and fluid dynamic) models Subsequently, investigate methods validity and relevance for quantitative prediction of treatment outcome in a clinical proof-of-concept trial (demonstrator) of patients with aortic valve desieases.

Official Title
-----------------
Smart - Systems Medicine of Heart Failure

Conditions
-----------------
Aortic Valve Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aortic Valve Stenosis Exclusion Criteria: coronary heart disease

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Hypertrophy | Muscle Mass and Fibrosis | 3 months |
Study to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore

Study Overview
=================
Brief Summary
-----------------
This prospective study aims to estimate the incidence of intussusception among children < 2 years old through hospital-based surveillance in Singapore.

Official Title
-----------------
Prospective, Hospital-based, Multicentre Study to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore

Conditions
-----------------
Intussusception

Intervention / Treatment
-----------------
* Other: Screening sheets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female infant aged < 24months at the time of diagnosis of intussusception. Subject is diagnosed with definite, probable, possible, suspected intussusception during the period of at least one year beginning at study start. Written informed consent obtained from the parent or guardian of the subject. Exclusion Criteria: A male or female infant ≥ 24 months of age at the time of intussusception diagnosis. The subject has had a radiographically or surgically confirmed case of intussusception prior to the current episode.

Ages Eligible for Study
-----------------
Maximum Age: 24 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intussusception cohort<br>Subjects with Intussusception | Other: Screening sheets<br>* Reviewing screening sheets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of definite, probable and possible IS cases in children < 5 yrs of age |  | Average timeframe: one year |
Spermatogonial Stem Cells in Azoospermic Patients: a Comparison Between Obstructive and Non-obstructive Azoospermia

Study Overview
=================
Brief Summary
-----------------
The researchers hypothesized that nonobstructive azoospermia might be associated with a reduction OF SSCs in seminiferous tubules as compared with obstructive azoospermia. Testicular sperm specimens that had been previously extracted from azoospermic patients will be paraffin embedded and stained with anti GPR-125. After antigen retrieval, the sections will be incubated with rabbit anti GPR125 followed by Cy3-conjugated anti rabbit secondary antibodies. Those found to be SSCs will be counted using light microscopy, and compared between patients with obstructive (n=11) and non-obstructive azoospermia (n=9).

Conditions
-----------------
Male Infertility

Intervention / Treatment
-----------------
* Other: Biospecimen staining
* Other: Biospecimen staining


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Azoospermic patients Exclusion Criteria: Patients with sperm cells

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 |
| --- | --- |
| I. Obstructive Azoospermia<br> | Other: Biospecimen staining<br>* The sections will be incubated with rabbit anti GPR125 followed by Cy3-conjugated anti rabbit secondary antibodies.<br>|
| II. Non-Obstructive Azoospermia Patients<br> | Other: Biospecimen staining<br>* The sections will be incubated with rabbit anti GPR125 followed by Cy3-conjugated anti rabbit secondary antibodies.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SSCs were identified in both obstructive and nonobstructive azoospermia patients. |  | One year |
Analysis of the Variation of the Retinal Vascularization After a Prolonged Effort

Study Overview
=================
Brief Summary
-----------------
The cardiovascular parameters of prolonged physical exercice have been studied, but very little data is available about the retinal vascularization. The eye allows in vivo visualization of micro-vascularisation and is considered as an excellent marker of general vascular condition. The marathon is an intense and prolonged exercise (running 42.195 km) in aerobic environment. Thus the investigators propose to study the vascular parameters of the retina, before and after this physical exercise. This will allow : 1) to collect information on the physiology of the retinal vascularization to prolonged effort, 2) to detect any retinal damage (haemorrhages, edema, occlusion ...), not known to date. The results may highlight vascular effects related to retinal hypoxia (venous tortuosity, haemorrhage, venous occlusion, hypoxic edema). Furthermore the results may urge prevention in this sport more and more democratized. the investigators hypothesized that prolonged physical exercice causes a change in retinal vascularization.

Official Title
-----------------
Analysis of the Variation of the Retinal Vascularization After a Prolonged Effort

Conditions
-----------------
Retinal Vascular Disorder, Sport Injury

Intervention / Treatment
-----------------
* Diagnostic Test: Color retinography
* Diagnostic Test: OCT-A
* Diagnostic Test: Blood pressure measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person registered at the 2019 Paris Marathon Exclusion Criteria: Ophthalmological disorders making access to the fundus impossible for both eyes

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 |
| --- | --- |
| Person running a marathon<br>Exams performed before (1 month maximum) and after the marathon (1 hour maximum) : Color retinography Optical Coherence Tomography - Angiography (OCT-A) Blood pressure measurement | Diagnostic Test: Color retinography<br>* Non mydriatic color retinography within 1 month before and within 1 hour after the marathon<br>Diagnostic Test: OCT-A<br>* Optical Coherence Tomography - Angiography within 1 month before and within 1 hour after the marathon<br>Diagnostic Test: Blood pressure measurement<br>* Blood pressure measurement within 1 month before and within 1 hour after the marathon<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Density of retinal vascular plexuses | Percentage, Measurement with OCT-A | up to 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinal Vascularization, Intense effort, OCT-A