linjc16/ctgov huggingface dataset:
Community Organizing Network for Environmental Health

Study Overview
=================
Brief Summary
-----------------
The Community Organizing Network for Environmental Health is a part of Community Action Against Asthma (CAAA), which, in turn is a part of the Michigan Center for the Environment and Children's Health. It is a community-based intervention research partnership between the University of Michigan, community-based organizations, and health care institutions in Detroit.

Detailed Description
-----------------
The aims of the Community Organizing Network for Environmental Health are to: share with community groups and organizations the findings from data collected through household and air quality research of the CAAA project; identify and engage existing community groups and organizations interested in working on environmental issues important to their neighborhood and community in the hopes of creating an interorganizational network (I.N.); work with member group of the I.N. to organize, coordinate and conduct activities to reduce physical environmental threats related to asthma; and increase community awareness and knowledge of factors associated with the environment and asthma through sharing of findings to community residents through presentations, annual reports, postings of websites, and community forums

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

Intervention / Treatment
-----------------
* Procedure: Community-level intervention & policy change


Participation Criteria
=================

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Community-level intervention & policy change|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
-----------------
Asthma, Children's Health, Community Based Research
NovaTears® Eye Drops Observational Study NT-003

Study Overview
=================
Brief Summary
-----------------
This observational study is intended to collect outcome data from a cohort of 30 patients suffering from dry eye disease due to chronic ocular Graft-versus-Host Disease (GvHD) who are treated with the medical device NovaTears® eye drops for a duration of 11 to 13 weeks.

Official Title
-----------------
NovaTears® Observational Study NT-003

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Device: NovaTears® Eye Drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: According to NovaTears® instruction for use ≥ 18 years Patients after an allogeneic hematopoietic stem cell transplantation with dry eye disease due to chronic ocular Graft-versus-Host Disease Ability and willingness to provide written Informed Consent Ability and willingness to participate in all examinations Willingness and ability to return for follow up visit Exclusion Criteria: Patients with known hypersensitivity to any of the components of NovaTears® Patients with contact lenses, pregnancies, or who are breast feeding Patients with dry eye disease caused by any other known underlying systemic disease Patients planning an ophthalmologic surgical procedure during the course of this PMCF study Patients using lipid-containing or tear-film stabilizing eye drops/sprays except cyclosporin formulations

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 |
| --- | --- |
| NovaTears®<br> | Device: NovaTears® Eye Drops<br>* Topical eye drops for lubrication of the ocular surface<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective symptom severity | Change in subjective symptom severity score compared to Baseline | 11-13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear-Film Break-up Time | Change in Tear Film Break-up Time (measured in seconds) compared to Baseline | 11 to 13 weeks |
HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB)

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the antiviral effects, immunogenicity, and safety of HepTcell in treatment-naive patients with inactive Chronic Hepatitis B (CHB) and low Hepatitis B surface antigen (HBsAg) levels.

Official Title
-----------------
Phase 2, Double-blind, Randomized, Placebo-controlled Study of HepTcell (Adjuvanted FP-02.2) as an Immunotherapeutic Vaccine in Treatment-naïve Patients With Inactive Chronic Hepatitis B (CHB)

Conditions
-----------------
Hepatitis B, Chronic

Intervention / Treatment
-----------------
* Biological: HepTcell
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18 to 65 years of age, inclusive Inactive CHB with documented HBsAg positivity for at least 12 months before Day 1 qHBsAg ≥ 10 IU/mL but ≤ 100 IU/mL in the 12 months prior to screening HBV DNA ≥ 10 IU/mL at screening AST, ALT, INR, albumin, total bilirubin (excluding patients with Gilbert Syndrome) and direct bilirubin within normal limits at screening Exclusion Criteria: Positive hepatitis B e antigen (HBeAg) at screening History of a hepatitis B flare or 1-log increase in HBV DNA or HBsAg in the prior 12 months Undetectable HBV DNA at screening Fibroscan > 8.5 kPA at screening, or history of hepatic fibrosis or cirrhosis (NB, a Fibroscan is not required if an examination is performed within 12 months or a liver biopsy was performed within 2 years before Screening and no fibrosis [F1 or greater] was identified).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HepTcell<br>Dose administered at intervals of 4 weeks for 6 doses | Biological: HepTcell<br>* Intramuscular injection<br>|
| Placebo Comparator: Placebo<br>Dose administered at intervals of 4 weeks for 6 doses | Drug: Placebo<br>* Intramuscular injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients achieving virologic responses |  | Baseline to Day 169 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients achieving serologic clearance of Hepatitis B surface antigen (HBsAg) |  | Baseline to Day 169 | 
| The proportion of patients achieving serologic clearance of Hepatitis B virus (HBV) DNA |  | Baseline to Day 169 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunotherapy, CHB
Clinical Evaluation of a Silicone Hydrogel Lens

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: lotrafilcon A contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months. Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner. Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses. Other protocol inclusion/exclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within 12 months prior to enrollment. Currently enrolled in any clinical trial. History of corneal refractive surgery. Other protocol inclusion/exclusion criteria may apply.
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

| Intervention/Treatment |
| --- |
|Device: lotrafilcon A contact lens|Investigational silicone hydrogel, single-vision, soft contact lens worn for four weeks at least as often as and on the same basis as participant's habitual lenses, as prescribed by participant's eye care practitioner -- ie., on a daily wear, flex wear, or extended wear basis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Preference | Overall preference when comparing study lenses to habitual lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer Habitual Lenses; Strongly Prefer Habitual Lenses. | 4 weeks of wear |
Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Estimate the efficacy of cortisol replacement therapy during the first 12 days of life for prevention of bronchopulmonary dysplasia. II. Estimate the effect of cortisol replacement therapy on the signs of acute adrenal insufficiency. III. Evaluate the effects of cortisol replacement therapy on adrenal hormone concentrations and on the ability of the adrenal gland to respond to ACTH. IV. Determine the effect of this replacement therapy on markers of inflammation in lung lavage fluid and peripheral blood leukocytes.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Hydrocortisone therapy IV or placebo begins no later than 48 hours after birth and continues every 12 hours for 12 days. Hydrocortisone is given at 2-4 times the basal cortisol secretion rate. Tracheal lavage on intubated babies is performed at start of study and on day 4 of life to assess concentrations of inflammatory markers. If larger babies show appropriate response to ACTH by 15-17 days and the less mature babies show a decreased response, then a longer course of therapy is proposed for future studies.

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

Intervention / Treatment
-----------------
* Drug: hydrocortisone


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- At risk for development of bronchopulmonary dysplasia --Patient Characteristics-- Hematopoietic: No congenital sepsis Hepatic: No structural defect of liver Renal: No agenesis or structural defect of a kidney Cardiovascular: No structural defect of the heart Metabolic: No diabetic mothers (e.g., preexisting insulin dependent, noninsulin dependent, and gestational diabetes) Pulmonary: No structural defect of the lung Other: Newborn birth weight must be 500 to 999 g and have endotracheal tubes in place at 12 hours of age Eligible if treatment can be given before 48 hours of postnatal life No major congenital anomaly causing significant defect in major organ system

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 1 Year

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

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: hydrocortisone|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
Immunohistochemical Expression of CXCL5 as a Valuable Prognostic Marker in Urinary Bladder Urothelial Carcinoma

Study Overview
=================
Brief Summary
-----------------
Urothelial carcinoma is common malignant tumor worldwide, it remains a challenge in the oncology field, it is an ideal for research on biomarkers that could identify tumor progression and prognosis. CXCL5 have been implicated in progression of many cancers, but their significance in urinary bladder UC remains unclear.

Detailed Description
-----------------
Bladder carcinoma has become a common cancer globally, Incidence rates are highest in Europe, the United States and Egypt. In Egypt, bladder carcinoma was considered the third most common tumor; Egyptian males have the highest mortality rates. UC of the urinary bladder represents about 90% of all bladder cancers. CXCL5 is a chemokine, belonging to ‗ELR+' subgroup. It plays an important role in angiogenesis and tumor migration. Numerous reports have indicated that CXCL5 plays important roles in cancer progression, including cholangiocarcinoma, prostate cancer, and gastric cancer. Studying the IHC expression of CXCL5 in UC to assess its role in tumor cell proliferation, migration and spread is needed.

Official Title
-----------------
Immunohistochemical Expression of CXCL5 as a Valuable Prognostic Marker in Urinary Bladder Urothelial Carcinoma

Conditions
-----------------
Urinary Bladder Urothelial Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients with primary invasive and non-invasive urinary bladder urothelial carcinomas. - Exclusion Criteria: - Patients received pre-operative chemotherapy or radiotherapy. Patients with insufficient clinical data. Specimens with extensive necrosis Tiny specimens which are insufficient for accurate diagnosis.
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the expression of CXCL5 in urothelial carcinoma | Immunohistochemical study | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CXCL5, Urothelial Carcinoma
Pilot Study of Vedic Medicine for Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the feasibility and effectiveness of a multimodality Vedic Medicine treatment protocol for the management of newly diagnosed type 2 diabetes.

Detailed Description
-----------------
Maharishi Vedic Medicine (MVM) represents a synthesis of Vedic sciences, including Ayur-Veda, into a single, comprehensive, natural approach to health care. The objectives of this phase II pilot trial are to determine the feasibility, acceptability, and safety of implementing a multi-modality MVM intervention for newly diagnosed type 2 diabetics, and to measure the impact of such a protocol on overall glycemic control.

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

Intervention / Treatment
-----------------
* Drug: Vedic Medicine
* Behavioral: Vedic Medicine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Kaiser Permanente members Newly diagnosed type 2 Diabetes Baseline glycosylated hemoglobin level of 6.0-7.9. Exclusion criteria: Pregnancy or nursing mother Currently taking warfarin Diagnosis of psychotic disorder or recent hospitalization for depression Unable to comply with or attend treatment sessions

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vedic Medicine|nan|
|Behavioral: Vedic Medicine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Glucose |  | 3 and 6 months | 
| Lipids |  | 3 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus Type 2, Vedic medicine, Ayurveda, Transcendental Meditation
The Impact of Lifestyle on Mental Health Among Young Men in the Gilgel Gibe Field Research Center, Ethiopia: Pilot Study

Study Overview
=================
Brief Summary
-----------------
Researchers of the three collaborating universities implement a pilot observational study in Gilgel Gibe Field Research Center, a health and demographic surveillance system run by the Jimma University, Ethiopia. In this setting, the investigators plan to study risk factors in young men for the development of common mental disorders and psychotic symptoms and the stability of distinct symptoms of mental disorders in the community. The investigators will explore in particular the impact of lifestyle on mental health in young men, including the traditional habit of chewing khat leaves, which contain amphetamine-like cathinone. Furthermore, the investigators want to demonstrate the reliability and validity of assessments performed by trained local interviewers.

Conditions
-----------------
Common Mental Disorders (CMD), Psychotic Symptoms

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, Age 18 - 30, permanent residents in Gilgel Gibe Exclusion Criteria: Prior existing severe mental health problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention, observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychotic symptoms | presence of self-reported psychotic symptoms during the month before interview | through study completion, within 2 months | 
| symptoms of Common Mental Disorders | presence of self-reported CMD symptoms during the month before interview | through study completion, within 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of khat use | self-reported amount of khat standard units consumed last week | through study completion, within 2 months | 
| amount of alcohol use | self-reported amount of alcohol standard units consumed last week | through study completion, within 2 months |
Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Objective: To investigate the potential role of endothelial dysfunction as a pathogenic mechanism of cardiovascular events in COPD. Hypothesis: endothelial function is abnormal in patients with COPD, particularly during exacerbations of the disease. Design: prospective and controlled study performed in an university hospital. Population: we compare 4 groups of subjects, 44 patients with stable COPD, 35 patients with acute exacerbation of COPD, 10 smokers or former smokers with normal lung function and 10 never smokers matched by physical activity and BMI. Study variables: a) clinical variables: clinical information, physical examination, pulmonary function tests, ECG and sputum culture; b) Biological variables: number of Circulating Endothelial Progenitor Cells, vascular growth factors (vascular endothelial growht factor and erythropoietin), systemic inflammation (C-reactive protein, white blood cells), peripheral venous blood test (including hemogram, biochemical analysis with glycemia, cholesterol, LDLcol, HDLcol); and c) systemic vascular reactivity assessment.

Official Title
-----------------
Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Endothelial Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with moderate to very severe COPD admitted in the hospital because of an exacerbation, and, Patients with moderate to very severe COPD in stable condition. Exclusion Criteria: Patients with an exacerbation of COPD who needed invasive or non invasive mechanical ventilation Patients with other chronic inflammatory diseases. Patients with other acute or active chronic systemic disease such as heart failure, renal insufficiency, etc.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with a COPD exacerbation | |
| 2<br>Patients with stable COPD | |
| 3<br>Smokers or former smokers | |
| 4<br>Never smokers | |

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
-----------------
COPD, exacerbations, EPCs, Erythropoietin, C-RP, COPD and endothelial dysfunction