linjc16/ctgov huggingface dataset:
Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan.

Official Title
-----------------
Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients

Conditions
-----------------
Ocular Hypertension, Glaucoma

Intervention / Treatment
-----------------
* Drug: Bimatoprost
* Drug: Lumigan®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent signed and dated. Both eyes with diagnosed open-angle glaucoma or ocular hypertension Exclusion Criteria: History of trauma, infection, clinically significant inflammation within the 3 previous months. Uncontrolled diabetic patient. Pregnancy or breast feeding.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T4032<br> | Drug: Bimatoprost<br>* Eyedrops<br>|
| Active Comparator: Lumigan®<br> | Drug: Lumigan®<br>* Eyedrops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-Ocular Pressure | Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye | Week 12 |
Safety and Efficacy of Prulifloxacin Versus Placebo in Traveler's Diarrhea

Study Overview
=================
Brief Summary
-----------------
The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of subjects with acute bacterial gastroenteritis.

Detailed Description
-----------------
This double-blind trial will compare the safety and efficacy of prulifloxacin versus placebo in adult travelers with acute gastroenteritis characterized by diarrhea with one or more of the following signs or symptoms: nausea, vomiting, abdominal pain or cramping, fecal urgency, moderate to severe gas-related symptoms, or tenesmus of ≤72 hours duration.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized Study to Compare The Safety and Efficacy of Prulifloxacin Versus Placebo in the Treatment of Acute Gastroenteritis in Adult Travelers

Conditions
-----------------
Acute Gastroenteritis in Adult Travelers

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Acute Bacterial Gastroenteritis; Traveler from Industrialized Country; Capable of giving Informed Consent Exclusion Criteria: Fever (>100.3 degrees); Pregnant or Breast Feeding or Not using adequate birth control; Known or Suspected (co-)Infection with non-bacterial pathogen; Symptoms of Gastroenteritis of >72 hours; Bloody Diarrhea; Concomitant antibacterial with activity against enteric bacterial pathogens; History of IBD; Unable/Unwilling to comply with study protocol; > 2 doses of anti-diarrheal medication within 24 hours; Antimicrobial Treatment within 30 days

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Prulifloxacin | Drug: Prulifloxacin<br>* Tablet<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to last unformed stool |  | Study days 1-3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure based on relief of signs and symptoms |  | Study days 1-3 | 
| Microbiologic eradication rates |  | Study days 1-3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroenteritis
Longitudinal Study of Children With Concussions

Study Overview
=================
Brief Summary
-----------------
For children and adolescents who have had a concussion resulting in prolonged symptoms (>3 months), the investigators will: Measure post-concussion symptoms, cognitive and emotional function during the 3 years post-injury. Determine length of recovery and frequency of return to prior level of sports participation. Determine the incidence of and risk factors for subsequent concussion during the 3 years post-injury.

Official Title
-----------------
Longitudinal Study of Children With Concussions: 3-year Follow-up of Cognitive and Emotional Function, Return to Sports, and Risk of Re-injury

Conditions
-----------------
Concussions

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between the ages of 8-17 years old who present to one of the Lurie Sports Medicine clinics for care of a concussion. English-speaking patients Exclusion Criteria: Patients outside of the 8-17 years old age range Patients who show structural abnormalities on neuroimaging. Non-English speaking patients

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No Intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-Term Effects of Concussion | All of the following measures will be aggregated using PROMIS - a computerized survey tool: what sports are played by the participant, whether or not the participant has quit a sport (due to concussion or not), development of anxiety or depression post-concussion, changes in peer relations post-concussion, change in cognitive function post-concussion, and if the participant has been subjected to a stigma after being diagnosed with a concussion. | 3 years |
Analysis of Anterior Chamber Inflammation by Optical Coherence Tomography

Study Overview
=================
Brief Summary
-----------------
A prospective, observational, case series investigating the feasibility of utilizing OCT scans of the anterior chamber of eyes with uveitis.

Official Title
-----------------
Automated Analysis of Anterior Chamber Inflammation by Optical Coherence Tomography

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients presenting to Cole Eye Institute with uveitis. Exclusion Criteria: Inability to provide informed consent, including non-English speaking and cognitively/mentally impaired. Severe corneal opacities preventing imaging of anterior chamber
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use the OCT to objectively image and grade the degree of anterior chamber inflammation in eyes with inactive and active uveitis. |  | one year |
COVID-19 Antibodies Among Healthcare Workers

Study Overview
=================
Brief Summary
-----------------
Observational, point of prevalence study determining the presence of anti-SARS-CoV-2 antibody

Detailed Description
-----------------
All Healthcare workers (HCW) who had entered contaminated areas at least once and that 14 days or more had passed from their first entrance to contaminated areas were included. They were classified as asymptomatic and pauci-symptomatic. A COVID-19 IgG/IgM rapid test was used for antibody detection, and selected participants were subject to real time polymerase chain reaction (qPCR) for SARS-CoV-2.

Official Title
-----------------
Prevalence of SARS-CoV-2 Antibodies Among Healthcare Workers in a COVID-19 Unit

Conditions
-----------------
COVID-19, SARS-CoV 2

Intervention / Treatment
-----------------
* Diagnostic Test: COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All healthcare workers who had entered contaminated areas at least once and that 14 days or more had passed from their first entrance were included Exclusion Criteria: Healthcare workers who did not have exposure for more or equal 14 days Healthcare workers who did not wish to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| exposed Healthcare workers<br>Healthcare workers working for 8 weeks in a COVID-19 area | Diagnostic Test: COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA)<br>* a blood sample is drained for detection of IgG and IgM antibody<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of antibody | presence of IgG and/or IgM against SARS-CoV-2 | through study completion, an average of 8 weeks |
Antibiotics in Infancy--Risk Factor for Childhood Asthma

Study Overview
=================
Brief Summary
-----------------
To examine possible relationships between antibiotic use, as determined by prescriptions filled, and asthma in children ages 6 to 7.

Detailed Description
-----------------
BACKGROUND: Morbidity and mortality from childhood asthma have been increasing in all developed countries over the past three decades, including in the United States. Numerous theories have been advanced to explain this asthma epidemic, but no single theory has held up to careful scrutiny. Recent international studies have suggested a relatively strong causal relationship between increased risk of childhood asthma and exposure to antibiotics during childhood, especially during the first year of life. The increased asthma risk was seen whether antibiotics were used to treat respiratory or non-respiratory infections. While these previous studies are suggestive, there are significant methodologic concerns about each study. A major concern with most of the studies is their reliance on retrospective recall of antibiotic exposure data from parents years after the exposure. The study relied on prospective data from the Childhood Asthma Study. DESIGN NARRATIVE: Data were used from the prospective, NIH-funded study of the relationship between early environmental exposures and the development of asthma in a birth cohort of children followed to an average 6.7 years of age. At 6.7 years, 482 (58%) of the original 833 children were clinically examined as part of this Childhood Asthma Study (CAS). In addition to clinical histories, the 6- to 7- year clinical examination included skin tests, IgE antibody tests, pulmonary function tests and methacholine challenge. At entry all of the CAS children were within the Health Alliance Plan (HAP) HMO. The study was based on combining the CAS data set with pharmacy data extracted from the HAP data archives. This allowed an examination of possible relationships between antibiotic use, as determined by prescriptions filled, and asthma at 6 to 7 years of age. While not strictly a prospective study, these methods avoided many of the potential sources of bias found in previous studies. The study was also able to evaluate any relationships between antibiotic exposure and asthma for confounding by other risk factors such as bedroom allergen levels, pet ownership, cigarette smoke exposure, and parental history of asthma or allergy.

Conditions
-----------------
Asthma, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 7 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 |
| --- | --- | --- |
AVIDA The Vidaza® (Azacitidine) Patient Registry

Study Overview
=================
Brief Summary
-----------------
This registry is a prospective, multi-center, observational study compiling data on the natural history and management of patients receiving Vidaza, and will provide unique insights into the management of myelodysplastic syndromes (MDS) and other hematological disorders and the impact of these disorders on patients.

Official Title
-----------------
AVIDA The Vidaza® (Azacitidine) Patient Registry

Conditions
-----------------
Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Drug: Azacitidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who is deemed appropriate for treatment with Vidaza® by his or her clinician, but who has not already started receiving Vidaza® treatment. Patient who is able to read and speak English. Patient who is willing and able to provide informed consent. Patient who agrees to complete patient assessment questionnaires. Exclusion Criteria: Patients who are currently being treated with Vidaza®. Patients who are concurrently participating in a clinical trial. Patients unwilling or unable to complete the baseline and follow-up questionnaires. Patients who are deemed inappropriate for treatment with Vidaza®.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Azacitidine|Physician's discretion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vidaza usage | Describe current usage patterns for Vidaza in the community | Approximately 4 years | 
| Concomitant care and treatment | Document common concomitant care procedures and treatments used in conjnction wtih Vidaza | Approximately 4 years | 
| Duration and number of cycles | Correlate duration and number of Vidaza treatment cycles with clinical response as defined by 2006 International Working Group for Myeleodysplastic Syndrome | Approximately 4 years | 
| Publication | Produce publications to support further clinical development and disseminate information on treatment best practices | Approximately 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDS
South Central Foundation - WISEWOMAN Project

Study Overview
=================
Brief Summary
-----------------
To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.

Detailed Description
-----------------
To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.

Official Title
-----------------
South Central Foundation - WISEWOMAN Project

Conditions
-----------------
CVD Risk

Intervention / Treatment
-----------------
* Behavioral: Women's health


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NBCCEDP Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 64 Years

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Women's health|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Bosentan on Endothelial Function in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate if oral treatment with bosentan improves endothelium-dependent vasodilatation in patients with type 2 diabetes and microangiopathy.

Official Title
-----------------
Effect of Bosentan on Macro- and Microvascular Function in Patients With Type 2 Diabetes

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus type 2 of >2 years duration Albuminuria Exclusion Criteria: Age >80 years Myocardial infarction/unstable angina within three months prior to randomisation Decompensated congestive heart failure or functional class 3 and 4. Changes in dosage of any vasodilator drugs during the preceding six weeks Women of fertile age. Impaired hepatic function (2 times upper normal limit of aminotransferases ASAT and ALAT) Ongoing treatment with glibenclamide, cyclosporin or warfarin Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol Participant in an ongoing study Unwillingness to participate following oral and written information

Ages Eligible for Study
-----------------
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Bosentan<br> | Drug: Bosentan<br>* 62.5 mg bid for two weeks and 125 mg bid for two weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matched placebo bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral endothelial function |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers |  | 4 weeks | 
| Renal protein excretion |  | 4 weeks | 
| Myocardial perfusion |  | 4 weeks |
Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Conduct a randomized, double blind, placebo controlled, parallel study of the atypical neuroleptic risperidone (RIS) in the treatment of children and adults with moderate to severe Tourette Syndrome. II. Evaluate further the safety of RIS in this population.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Initially, all patients receive placebo capsules twice daily in a single blind fashion during the first 2 weeks of study. Then, patients are randomized to receive either risperidone (RIS) or placebo for 8 weeks. The dose of RIS is increased weekly over the first 4 weeks of treatment, as tolerated. Patients continue RIS for 4 additional weeks at the dose prescribed during week 4. All patients receive diagnostic evaluations at the beginning and end of the 2 week initial single blind phase, and at the end of weeks 2, 4, 6, and 8 of the active treatment phase.

Conditions
-----------------
Tourette Syndrome

Intervention / Treatment
-----------------
* Drug: risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- DSM-IV diagnosis of Tourette Syndrome (TS) Tic symptoms greater than 3 (moderate or worse) on the Global Clinical Impression Scale for TS --Prior/Concurrent Therapy-- No concurrent use of other medications during study A minimum of 4 weeks since prior use of other medications and 8 weeks for neuroleptics or fluoxetine --Patient Characteristics-- Hepatic: No hepatic disease Renal: No renal disease Cardiovascular: No heart disease No hypertension Pulmonary: No pulmonary disease Other: Not pregnant IQ at least 70 required No other movement disorder allowed, such as tardive dyskinesia No major depression No pervasive developmental disorder No autism or psychotic disorder based on DSM-IV No alcohol or substance abuse No hypersensitivity to risperidone All subjects must be in good health

Ages Eligible for Study
-----------------
Minimum Age: 7 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: risperidone|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
-----------------
Tourette syndrome, neurologic and psychiatric disorders, rare disease