linjc16/ctgov huggingface dataset:
Periodontal Disease and Preterm Birth

Study Overview
=================
Brief Summary
-----------------
To determine the relationship between periodontal disease and upper genital tract inflammation in pregnancy. To determine whether certain fluid levels in the oral cavity and the vagina are associated with preterm birth or low-birth weight.

Detailed Description
-----------------
Patients will be enrolled in the study at their first prenatal visit after the details of the study have been discussed. Potential subjects will be presented with a questionnaire to determine eligibility for the study. The patient will be scheduled for an exam between 18-24 weeks at which time they will undergo a periodontal assessment, to determine the presence or absence of periodontal disease, a sampling of gingival crevicular fluid (GCF) and a vaginal swab collection. Periodontal disease will be determined by measuring the depth of gingival sulci, amount of periodontal attachment loss, and prevalence of gingival bleeding at six sites for each tooth present.

Official Title
-----------------
Periodontal Disease, Inflammatory Markers, and Preterm Birth

Conditions
-----------------
Periodontal Disease, Preterm Birth, Low Birth Weight

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 15-35 Singleton gestation Exclusion Criteria: Diabetes prior to pregnancy Require antibiotic prophylaxis prior to dental treatment Require steroids during pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Pregnant Women | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the relationship between periodontal disease and upper genital tract inflammation as measured by cytokine levels IL-6, IL-1, and TNF-α and MMP levels from the posterior fornix of the vagina. |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether IL-1β levels in the oral cavity and the vagina are associated with preterm birth or low-birth weight. |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periodontal Disease, Preterm Birth, Low Birth Weight, Pregnancy
Study Evaluating Nasal Symptoms Induced by a Nasal Allergen Challenge (NAC) To House Dust Mite Allergen

Study Overview
=================
Brief Summary
-----------------
A Multi-Center Study Evaluating the Nasal Allergic Symptomatology Induced by a Nasal Allergen Challenge (NAC) in a Dust Mite Population

Conditions
-----------------
Allergic Rhinitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be at least 18 years of age positive ST to Dust Mite history of allergic rhinitis Exclusion Criteria: no active infections no disallowed medications no nasal anatomical deformities or nasal surgical interventions in the past

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 |
| --- | --- | --- |
| TNSS= total nasal symptoms score |  | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual nasal symptoms |  | 15 minutes |
REsponsiveness to CLOpidogrel and Stent-related Events in Acute Coronary Syndromes (RECLOSE 2 - ACS)

Study Overview
=================
Brief Summary
-----------------
The main objective of the project is to assess the long-term prognostic impact of residual platelet reactivity after optimal antiplatelet therapy in a large cohort of patients with acute coronary syndrome undergoing invasive strategy. Follow-up length will be at least 24 months. The primary end-point of the study will be a composite of death, myocardial infarction, urgent target vessel revascularization, stent thrombosis or stroke.

Detailed Description
-----------------
This study is mainly based on a registry of 2000 consecutive patients with acute coronary syndrome who received invasive treatment and for whom platelet reactivity after clopidogrel treatment will be prospectively assessed. In the acute phase, blood samples for platelet reactivity assessment will be obtained 12 to 18 hours from 600 mg clopidogrel loading. Platelet-rich plasma, obtained by centrifuging whole blood for 10 min at 200 g, was stimulated with 10 M adenosine 5'-diphosphate (ADP) and residual aggregation will be assessed using a APACT 4 light transmittance aggregometer. Platelet aggregation (according to the Born's method) will be evaluated considering the maximal percentage of platelet aggregation in response to stimulus. Patients with platelet aggregation by 10 µmol ADP ≥ 90th percentile of controls (70%) will be defined as non-responders. The assessment of platelet reactivity will be repeated at 6 months. The importance of concomitant aspirin resistance will be also evaluated in such of patients.

Official Title
-----------------
REsponsiveness to CLOpidogrel and Stent-related Events in Acute Coronary. Reclose 2-ACS Registry

Conditions
-----------------
Acute Cardiac Syndrome, Stent Thrombosis, Platelet Function, Antiplatelet Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute coronary syndrome invasive treatment Exclusion Criteria: in-hospital death that was not due to stent thrombosis, anticipated poor compliance to dual antipletelet treatment for at least 6 months, premature discontinuation of clopidogrel therapy.

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 |
| --- | --- | --- |
| long-term prognostic impact of residual platelet reactivity | to assess the long-term prognostic impact of residual platelet reactivity after optimal antiplatelet therapy in a large cohort of patients with acute coronary syndrome undergoing invasive strategy. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute cardiac syndrome, stent thrombosis, platelet function, antiplatelet therapy
Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether interferon-beta impairs the ability of plasmacytoid dendritic cells to promote pathogenic immune responses in patients with multiple sclerosis.

Official Title
-----------------
Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Interferon-beta 1b (Betaseron)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, 18 to 60 year old, inclusive. Diagnosis of a relapsing form of multiple sclerosis as determined by revised McDonald Criteria or at least one clinical demyelinating episode with abnormal brain MRI study based on CHAMPS criteria Expanded disability status scale (EDSS) score less than 6 at entry. Understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care. Exclusion Criteria: Treatment with corticosteroids within one month prior to the study. Treatment with immunomodulatory drugs within last 3 months prior to the study. No history of treatment with Interferon-beta(IFN-beta) based drugs to exclude the possibility of IFN-beta neutralizing antibodies Any patient who is pregnant, intend to become pregnant, or breastfeeding at any time of the study. History of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude IFN-beta therapy. Primary Progressive Multiple Sclerosis patients or patients with Secondary Progressive Multiple Sclerosis with lack of recent clinical relapses for more than 2 years

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>MS patients or patients with CIS (Clinically isolated syndrome) who decided to be treated with IFN-beta for 3 months (with the option to continue Rx) | Drug: Interferon-beta 1b (Betaseron)<br>* Treatment of patients with FDA-approved Rx<br>|
| 2<br>MS patients or patients with CIS(Clinically isolated syndrome)who decided to postpone the treatment with IFN-beta | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative gene expression in plasmacytoid dendritic cells (pDCs) | Gene expression is tested in pDCs separetd from peripheral blood of human subjects at baseline and at 12 weeks | Change in gene expression in 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple sclerosis, Interferon beta, plasmacytoid dendritic cells
Silent Cerebrovascular Lesion and Cognitive Decline Prevention by Cholesterol Lowering in Elderly AF Patients

Study Overview
=================
Brief Summary
-----------------
In elderly patients with atrial fibrillation (AF) the presence of silent brain infarcts and neurocognitive deficit is high despite adequate treatment with oral anticoagulation. Atherosclerosis is considered to be a chronic inflammatory disease and thrombosis and inflammation are strongly correlated. Atrial fibrillation is linked with increased levels of inflammatory markers and intensive cholesterol lowering has proven to reduce inflammation. In a prospective double-blind randomized pilot-study we want to test the hypothesis, that addition of intensive cholesterol lowering treatment besides adequate oral anticoagulation will reduce cerebrovascular lesions and will be beneficial for neurocognitive status in elderly AF patients.

Official Title
-----------------
Silent Cerebrovascular Lesion and Cognitive Decline Prevention in Atrial Fibrillation by Intensive Cholesterol Lowering in Elderly Patients

Conditions
-----------------
Atrial Fibrillation, Neuropsychology, Magnetic Resonance Imaging, Inflammation, Hemostasis

Intervention / Treatment
-----------------
* Drug: Atorvastatin
* Drug: ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elderly patients (>68 and <82 years) with atrial fibrillation and adequate oral anticoagulation therapy and cholesterol levels between 4,5 mmol/l and 7 mmol/l Exclusion Criteria: Indication for cholesterol lowering treatment according to Dutch CBO-cholesterol guidelines (2004)

Ages Eligible for Study
-----------------
Minimum Age: 68 Years
Maximum Age: 82 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atorvastatin|nan|
|Drug: ezetimibe|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive function |  |  | 
| Cerebrovascular lesions on MRI |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of inflammatory markers |  |  | 
| Level of hemostatic markers |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, elderly, cholesterol lowering, neurocognitive function, cerebrovascular lesion
Long-Term Follow-up Study for Patients Previously Treated With JCAR015

Study Overview
=================
Brief Summary
-----------------
This study will provide long-term follow-up for patients who have received treatment with JCAR015 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of JCAR015 for evaluation of delayed adverse events, presence of persisting JCAR015 vector sequences, and survival.

Official Title
-----------------
Long-Term Follow-up Protocol for Subjects Treated With JCAR015

Conditions
-----------------
Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Genetic: JCAR015


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients who have received at least one dose of JCAR015 in a previous treatment protocol. Patients who have provided informed consent for the long-term follow-up study prior to study participation. Exclusion criteria: None. All patients who have previously received JCAR015 treatment are eligible for this long-term follow-up study.

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 |
| --- | --- |
| JCAR015-treated<br>Patients who received previous treatment with JCAR015 | Genetic: JCAR015<br>* No study drug is administered in this study. Patients who received JCAR015 in a previous trial will be evaluated in this trial for long-term safety and efficacy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with adverse events |  | Every year for up to 15 years post-treatment | 
| Proportion of patients with detectable JCAR015 vector sequences during first 5 years post-treatment |  | Every 6 months for the first 5 years post-treatment | 
| Proportion of patients with detectable JCAR015 vector sequences between 5 and 15 years post-treatment |  | Every year from 5 years post-treatment to up to 15 years post-treatment | 
| Survival |  | Up to 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
long-term follow-up, chimeric antigen receptor (CAR) T cells, JCAR015
Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the epidemiology of pulmonary hypertension in individuals with HIV infection and to investigate its pathogenesis. We propose to conduct a prospective observational cohort study to determine the association between highly active antiretroviral therapy (HAART) and viral suppression in HIV-infected patients who have been identified to have pre-clinical pulmonary hypertension (Aim 1). In addition, we will investigate the mechanistic role of the HIV-1 Nef protein and HHV-8 infection in the development and progression of pulmonary hypertension in individuals with HIV (Aim 2). We will also investigate endothelial function in HIV-infected patients with pulmonary hypertension (Aim 3).

Official Title
-----------------
Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension

Conditions
-----------------
HIV Infection, Pulmonary Hypertension, Endothelial Function, HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infection with HIV greater than 6 months in duration Right heart catheterization showing PASP > 30mm Hg Ability to provide reliable history of HIV medications or has received the majority of medical care from San Francisco General Hospital with available records of medical treatment. Ability to participate in follow-up for the duration of the study. Exclusion Criteria: Known significant cardiovascular disease, including clinically significant valvular heart disease, congenital heart disease, current or prior symptomatic coronary disease, or known cardiomyopathy. Any known pulmonary disease that could potentially cause pulmonary hypertension. A pO2 by pulse oximetry below 90% on room air. Obstructive sleep apnea. Known collagen vascular disease. History of anorexigen use 7. Age less than 18 years old. 8. Other co-morbidities for which the investigators, in conjunction with the primary care provider, believe render the participant with an expected survival of 6 months or less.

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 |
| --- | --- |
| HIV Infection<br>HIV-infected individuals with the clinical diagnosis of pulmonary hypertension or HIV-infected individuals who have mildly elevated pulmonary arterial pressures | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary artery pressure |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV infection, pulmonary hypertension, endothelial function, antiretroviral medication, Treatment Experienced
Bioequivalency Study of Clarithromycin Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a potential generic 500 mg clarithromycin tablet formulation compared with Abbott Laboratories 500 mg clarithromycin tablet, Biaxin® following a single 500 mg dose, administered with food.

Official Title
-----------------
A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of 500 mg Clarithromycin Tablets Under Fed Conditions

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Drug: Clarithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to clarithromycin or any other macrolide antibiotic.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Clarithromycin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Seven day washout |
Antimicrobial Susceptibility Patterns of N. Gonorrhea Isolates in an Era of Quinolone Resistance

Study Overview
=================
Brief Summary
-----------------
To perform a laboratory sensitivity testing survey of antibiotic agents against Neisseria gonorrhea isolates from men with symptomatic urethritis seen at an STD clinic.

Detailed Description
-----------------
Until recently, the fluoroquinolones (ofloxacin, ciprofloxacin, levofloxacin) have been the first line oral agents for the empiric treatment of gonorrhea. The prevalence of quinolone resistant Neisseria gonorrheae (QRNG) has been rising since 2000. In 2006, the CDC updated its guidelines to include recommendations against the use of quinolones for treatment of Neisseria gonorrheae. Ceftriaxone (available only by intravenous or intramuscular route) was named as the first line treatment for urogenital and pharyngeal disease. Availability, in the United States, of the other two CDC recommended agents cefixime (oral) and spectinomycin (IM) has been nonexistent. At this time, there is little data on the in-vitro (laboratory test) susceptibility of antibiotics against gonorrhea, particularly oral drugs. The purpose of this study is to collect specimens of gonorrhea in a non-invasive swab manner from men with symptomatic urethral discharges for laboratory sensitivity testing against a wide array of antibiotic agents. Specific Aims: To perform a laboratory sensitivity testing survey of antibiotic agents against Neisseria gonorrhea isolates from men with symptomatic urethritis seen at a Duval County STD clinic .

Official Title
-----------------
Antimicrobial Susceptibility Patterns of Neisseria Gonorrhea Isolates in an Era of Quinolone Resistance

Conditions
-----------------
Gonorrhea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men between the ages of 18 to 80 years old with suspected urethral gonorrhea by symptoms or gram stained smear Exclusion Criteria: Patients less than 18 years old or greater than 80 years old Inability to give an informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neisseria gonorrheae, Antimicrobial Susceptibility, Quinolone Resistance, Sexually transmitted diseases