linjc16/ctgov huggingface dataset:
Comparison of HIV Testing Algorithms

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to assess whether an improved MSF HIV diagnostic algorithm which includes a simple and easy to perform confirmation test has significantly better positive predictive value than WHO recommended RDT testing algorithms that do not include confirmatory testing.

Detailed Description
-----------------
Rapid Diagnostic Tests (RDT's) are essential tools in antiretroviral treatment (ART) scale up. An important drawback to RDTs is the risk of false positive results. In 2005, MSF-Holland has therefore changed the testing algorithm to introduce a confirmation test. This proposal outlines an evaluation study of the results of the new confirmatory testing algorithm. It aims to compare the confirmatory algorithm employed by MSF-OCA to the MoH serial algorithm which is based on WHO recommendations. A secondary objective of the study is to determine if there is a correlation between kala-azar infection and risk of false positive HIV RDT results as clinicians in the projects suspect such a correlation. Furthermore, the study will look at the positive predictive value of weak test lines, which have been associated with higher risk of false positive results. Finally, the study aims to evaluate the results of a new simplified confirmation test, the dilution testing. Clients for the study will be recruited at two counseling and testing sites in Abdurafi and Humera, aiming to reach a sample size of 200 serial-algorithm positive and 200 negative samples in each site.

Official Title
-----------------
Comparison of HIV Testing Algorithms in Two Sites in Ethiopia

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Other: application of a confirmation test
* Other: application of a confirmation test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Age >= 59 months (to help ensure success of venepuncture) Informed consent from the individual or guardian to participate in study Exclusion Criteria: • Inability to obtain venous blood sample Withdrawal of consent to test or to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 5 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: application of a confirmation test|Addition of confirmation test to serial testing algorithm, including dilution test|
|Other: application of a confirmation test|use of rapid confirmation test|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV result by Western Blot |  | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Diagnostics
Validation of a Pediatric-Specific Abstinence Syndrome Assessment Tool

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the validity and reliability of an abstinence syndrome assessment tool used in pediatric patients with iatrogenic opioid dependence.

Official Title
-----------------
Validation of a Pediatric Abstinence Syndrome Scoring Tool Utilizing a Standardized Hospital-Based Guideline for Iatrogenic Opioid Dependence

Conditions
-----------------
Substance Withdrawal Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric Intensive Care Unit patients ages 2 weeks to 18 years Patients receiving continuous opioid infusions for 5 days (at least 120 hours) or more Exclusion Criteria: Attending discretion Patients with deterioration of medical status requiring interventions of pain control, surgery, sedation, or re-intubation

Ages Eligible for Study
-----------------
Minimum Age: 2 Weeks
Maximum 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 |
| --- | --- |
| 1<br>Limited continuous opioid exposure (at least 120 and less than 156 hours) | |
| 2<br>Extended continuous opioid exposure (156 hours or more) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total scores of abstinence syndrome symptoms |  | Up to 23 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expert opinion on abstinence syndrome |  | Up to 23 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abstinence syndrome symptoms, Withdrawal symptoms, Opioid dependence
Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The Ulcerative Colitis (UC) belongs to the group of diseases called Inflammatory Bowel Disease (IBD) which is characterized by a chronic ulceration of the colon. The conventional treatment can have adverse effects and does not guarantee effectiveness in some patients requiring aggressive therapy using adjuvant therapy Aloe vera has been shown to have a beneficial effect in different disease, and have an anti-inflammatory effect in UC patients. Objective: Measuring the effect of the consumption of 200 ml of aloe vera gel daily for a period of three months, in the degree of inflammation in patients with mild UC based on Mayo scale and quantification of IL-6 in the colonic mucosa.

Official Title
-----------------
Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Dietary Supplement: Aloe Barbadensis Miller
* Dietary Supplement: placebo water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with confirmed diagnosis by histopathology of Ulcerative Colitis with mild activity level clinical, Endoscopic and histological. Extent of disease: pancolitis, ulcerative proctitis and left. Being treated with 5 - aminosalicylates (5-ASA). Belonging to the National Institute of Medical Sciences and Nutrition Salvador Zubirán. Signed informed consent. Exclusion Criteria: Autoimmune diseases (lupus, HIV, cancer and any hepatitis). Another type of colitis (indeterminate, infectious drug and Crohn's Disease. Previous total colectomy. Body mass index less than 19.9 kg/m2 or greater than 40 kg/m2. Patients in remission histology, clinical and endoscopic. Under treatment with steroids, azathioprine, diuretics and anticoagulants. Use Aloe Vera or some natural therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aloe Vera<br>Consume 200 ml of aloe vera gel per day over a period of three months | Dietary Supplement: Aloe Barbadensis Miller<br> <br> |
| Placebo Comparator: water<br>Consume 200 ml of placebo per day over a period of three months | Dietary Supplement: placebo water<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full Mayo Score |  | 3 months | 
| Interleukine - 6 | Quantification in mucosal Biopsy | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulcerative Colitis, Aloe Vera
Study of the Role of Dendritic Cells in the Recurrence of Hepatitis C After Liver Transplantation. Analysis of Hepatitis C Virus (HCV) Quasispecies Evolution.

Study Overview
=================
Brief Summary
-----------------
Re-infection of the liver graft occurs universally following liver transplantation for HCV-induced end stage liver disease. Interestingly, the manifestation of HCV infection ranging from an asymptomatic carrier state to rapid progression to liver cirrhosis is extremely variable from one patient to another. The host and viral factors being responsible for the different course of HCV infection are poorly understood. Our study will focus on dendritic cells which are known to play a critical role in the control of viral infection. Viral factors (quasispecies evolution) will also be analysed and Th1 Th2 cytokines produced in the serum evaluated.Thirty liver transplanted patients will be included : 20 patients transplanted for HCV-related disease and 10 controls transplanted for non HCV-related disease. Blood samples will be taken just before transplantation and at different time -points up to 5 years after transplantation. Function of blood monocyte-derived DC will be evaluated. Circulating blood plasmacytoid (pDC) and myeloid DC (mDC) sub-populations will be enumerated. HCV quasispecies evolution will be analysed. This study may help to define prognostic markers on progression of hepatitis C in liver transplantation and allow the development of new immunotherapeutic drugs

Official Title
-----------------
Liver Transplanted Patients for HCV Related End Stage Liver Disease.Functional Role of Blood Circulating Dendritic Cells in the Pathogenesis of Hepatitis C Virus Infection During Liver Transplantation.

Conditions
-----------------
HCV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver transplanted HCV infected patients : Adults, HIV(-),HBV(-) liver transplanted for an end stage liver disease associated to HCV. Genotype determined written agreement to participate to the study Control patients : Adults, HIV(-), HBV(-), HCV(-) liver transplanted for a non HCV liver disease written agreement to participate to the study. Exclusion Criteria: HIV(+), HBV(+)

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 |
| --- | --- | --- |
| Function of blood circulating DC at day 7 and 1, 3, 6, 9, 12 months, 2 and 5 years after liver transplantation depending on the clinical outcome (mild or severe hepatitis, cirrhosis). |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dendritic cells, liver transplantation, hepatitis C virus, quasispecies, virological markers, biochemical markers, immunological markers, clinical markers
A Randomized, Sham Device Controlled, Single Blinded Trial of Portable Transcutaneous Electrical Nerve Stimulation and Heat Therapy Machine in Women With Dysmenorrhea

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.

Detailed Description
-----------------
Inclusion/Exclusion: Described in Eligibility section. Outcome measures: Change of VAS score before and after use of TENS and heat therapy machine.

Conditions
-----------------
Dysmenorrhea

Intervention / Treatment
-----------------
* Device: I RUNE
* Device: sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Age>19 Premenopausal Moderate or severe dysmenorrhea, mainly in low abdomen area Exclusion Pregnant Surgery history on lower abdomen Recent history of cancer TENS device use is contraindicated Ibuprofen use is contraindicated

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

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Sham Comparator: Sham<br>Using not functioning device | Device: sham<br> <br> * Other names: sham device;|
| Experimental: Experimental<br>Using functioning device | Device: I RUNE<br> <br> * Other names: Transcutaneous electrical nerve stimulation and heat therapy machine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of VAS before and after application of machine | Measure the change% of VAS between before application of machine (T0) and 20 minutes after application of machine (T20) in every episode of dysmenorrhea during 1 menstrual cycle The mean of change% of VAS is primary outcome measure | Immediately before application of machine and 20minutes after application of machine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BPI score | Brief Pain Inventory score | 2nd day of menstrual cycle | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dysmenorrhea, transcutaneous electrical nerve stimulation, heat therapy
Phase III Randomized, Double-Blind Study of Dexamethasone Vs Dexamethasone/Methylprednisolone Vs Placebo for Bronchopulmonary Dysplasia

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Compare the efficacy of dexamethasone (DM) vs. DM/methylprednisolone treatment vs. placebo, initiated within the first month of life, on long-term pulmonary and developmental outcomes in premature infants with evolving bronchopulmonary dysplasia. II. Compare the toxicities of these treatments. III. Assess treatment effects on adrenal function.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to 1 of 3 treatment groups. The first group receives intravenous dexamethasone tapered over 42 days. The second group receives daily intravenous dexamethasone for 6 days, then intravenous methylprednisolone (MePRDL) tapered over the next 34 days, beginning on day 8. A placebo is given on off MePRDL days. The third group receives an intravenous placebo for 42 days, with a tapering schedule beginning day 35. All patients may receive 6 days of dexamethasone rescue therapy beginning day 15 and/or 30, as clinically indicated. Study drugs are suspended during rescue therapy.

Conditions
-----------------
Bronchopulmonary Dysplasia

Intervention / Treatment
-----------------
* Drug: dexamethasone
* Drug: methylprednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Premature infants with evolving bronchopulmonary dysplasia on chest x-ray Requirement for mechanical ventilation Fraction of inspired oxygen greater than 0.30 Ventilator at least 15 cycles/minute No signs of weaning within 72 hours prior to entry No serious congenital anomaly --Prior/Concurrent Therapy-- No prior postnatal corticosteroids --Patient Characteristics-- Cardiovascular: No congenital heart disease Other: Birth weight no greater than 1500 g Gestational age no greater than 30 weeks No contraindication to corticosteroids, e.g., culture-proven bacterial sepsis

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 2 Weeks

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dexamethasone|nan|
|Drug: methylprednisolone|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
-----------------
bronchopulmonary dysplasia, cardiovascular and respiratory diseases, neonatal disorders, rare disease
Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of individuals with Smith-Magenis Syndrome.

Official Title
-----------------
A Double-blind, Randomized, Two-period Crossover Study Evaluating the Effects of Tasimelteon vs. Placebo on Sleep Disturbances of Individuals With Smith-Magenis Syndrome (SMS)

Conditions
-----------------
Smith-Magenis Syndrome, Circadian

Intervention / Treatment
-----------------
* Drug: tasimelteon
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A confirmed clinical diagnosis of SMS Informed consent from the patient or the legal guardian Male or female between the ages of 3- 65 years of age Recent history of sleep disturbances Have an appointed care-giver complete the required outpatient assessments Willing and able to comply with study requirements and restrictions Exclusion Criteria: Unable to dose daily with medication Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening Any other sound medical reason as determined by the clinical investigator

Ages Eligible for Study
-----------------
Minimum Age: 3 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tasimelteon<br>Single dose oral capsule or equivalent age-appropriate oral formulation, daily dosage | Drug: tasimelteon<br> <br> |
| Placebo Comparator: Placebo<br>Placebo comparator | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parameters |  | 9 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as measured by spontaneous reporting of adverse events (AEs). |  | up to 137 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SMS
Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if intranasal ketamine is equally as effective and safe as intramuscular ketamine for procedural sedation in pediatric patients.

Official Title
-----------------
Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation: A Prospective Randomized, Double-blinded, Placebo Controlled Study

Conditions
-----------------
Sedation

Intervention / Treatment
-----------------
* Drug: Ketamine
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients age 2 to 17 years old have a laceration of 4 cm on the face or 7 cm on the remainder of the body Require procedural sedation to repair the laceration Exclusion Criteria: Patients with abnormal nasal physiology which would not allow for adequate medication delivery Unable to have a guardian present to consent on their behalf Allergy to ketamine Significant cardiac history (myocardial ischemia, heart failure, arrhythmias) Presenting with a head injury associated with possible intracranial hypertension Pregnancy Lacerations that require repair from a consult service

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
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: Intranasal Ketamine<br> | Drug: Ketamine<br>* Intranasal Ketamine (100 mg/mL)<br>|
| Active Comparator: Intramuscular Ketamine<br> | Drug: Ketamine<br>* Intramuscular Ketamine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of Sedation | Minutes it takes until the patient is cooperative enough for the procedure | Every 60 seconds through study completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Procedural Sedation