linjc16/ctgov huggingface dataset:
Cooperative Study of Factor VIII Inhibitors

Study Overview
=================
Brief Summary
-----------------
To test the efficacy of prothrombin complex concentrates (Factor IX) in the treatment of hemophiliac patients who had inhibitors to Factor VIII.

Detailed Description
-----------------
BACKGROUND: Despite major advances in the treatment of patients with hemophilia, a serious remaining challenge was presented by the occurrence of circulating inhibitors to Factor VIII. Because of lack of information on the natural course of patients with Factor VIII inhibitors, the relative efficacy of various modes of therapy was not established. The Division of Blood Diseases and Resources decided to sponsor a clinical investigation which would evaluate populations of hemophilia patients for Factor VIII inhibitors, follow up these patients to provide information on the natural history of the inhibitor in the hemophilia patients, and make available a reference center to monitor results and attain uniformity. Treatment of a patient with a severe inhibitor and consequent bleeding remained a problem. Management included protracted treatment with Factor VIII, use of immunosuppressive agents and prothrombin complex (or Factor IX) concentrates. The rationale for Factor IX was that it bypassed the defect in Factor VIII caused by the inhibitor. This method of therapy attracted wide popularity, but the success was greatly debated. It was intended at the very outset of the Factor VIII study that therapeutic trials involving patients with inhibitors would not be a prime function, but that such studies would be monitored if necessary. A controlled trial of Factor IX concentrates therapy was strongly advised by the DBDR Advisory Committee. Accordingly, during fiscal year 1978, a protocol for a double-blind control study was developed by the Factor VIII inhibitor group. The trial began in the spring of 1978, and the intervention terminated about one year later. DESIGN NARRATIVE: Double-blind study; patients served as their own controls. A total of 51 patients each received a single large dose of Konyne, Proplex, or diluted albumin (as a control). Joint bleeding of the elbow, knee, and ankle was evaluated six hours after each dose.

Conditions
-----------------
Blood Coagulation Disorders, Hematologic Diseases, Hemophilia A, Hemorrhagic Disorders

Intervention / Treatment
-----------------
* Drug: factor ix


Participation Criteria
=================
Eligibility Criteria
-----------------
Males with hemophilia, not stratified as to ethnic group.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: factor ix|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of an HIV Outreach Program

Study Overview
=================
Brief Summary
-----------------
This study evaluates outreach to HIV-infected people living in unstable housing in New York City who are new to CitiWide Harm Reduction. One hundred and fifty people are interviewed every 6 months, and their medical records are reviewed every 6 months for a total of 18 months. The study examines how outreach, case management, housing, drug use, mental health, and quality of life are related to people's ability to get into and stay in medical care.

Detailed Description
-----------------
The study is a prospective cohort study in which 150 newly enrolled HIV-infected participants of CitiWide Harm Reduction are followed for 18 months to assess HIV-related health outcomes. Data elements include (1) face-to-face interviews focusing on housing, HIV disease severity, utilization of health care services, utilization of non-medical services, substance use, mental health, and quality of life; (2) medical chart information focusing on CD4 count, viral load, and HIV primary care visits; and (3) outreach services. The study hypothesis is that involvement with CitiWide Harm Reduction will improve HIV-related health care utilization and outcomes.

Official Title
-----------------
Evaluation of an Outreach and Intervention Program to Reach HIV- Positive Persons Living in Bronx, NY Single Room Occupancy Hotels

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected, living in one of 15 single room occupancy hotels served by CitiWide Harm Reduction, new to CitiWide Harm Reduction, at least 18 years of age, English or Spanish speaking Exclusion Criteria: HIV-negative

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, homeless, health services accessibility, health services research, social support, AIDS, substance abuse, mental health, quality of life, outreach, harm reduction
Performance of FISH for the Diagnosis of Malignant Biliary Strictures in Thai Patients

Study Overview
=================
Brief Summary
-----------------
Fluorescence in situ hybridization (FISH) has improved the diagnostic performance of cytology for evaluation of malignant biliary strictures in the US and Europe. The utility of FISH for diagnosis of biliary strictures in Asia is currently unknown. The investigators conducted a prospective study in 2 university hospitals to determine diagnostic performance of FISH for the diagnosis of malignant biliary strictures in Thai patients.

Detailed Description
-----------------
Fluorescence in situ hybridization (FISH) has improved the diagnostic performance of cytology for evaluation of malignant biliary strictures in the US and Europe. The utility of FISH for diagnosis of biliary strictures in Asia is currently unknown. The investigators aimed to compare the sensitivity of FISH and conventional cytology for the diagnosis of malignant biliary strictures in Thai patients. A prospective study was performed in 2 university hospitals between 2010 and 2013. Patients being evaluated for malignant-appearing biliary strictures were included. Bile duct brushings were collected and assessed by cytology and FISH. Sensitivities with 95% confidence intervals of cytology and FISH were main outcome measurements.

Official Title
-----------------
Fluorescence in Situ Hybridization (FISH) Improves Performance of Conventional Cytology for the Diagnosis of Malignant Biliary Tract Strictures in Thai Patients

Conditions
-----------------
Bile Duct Stricture, Malignancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Clinical suspicion of malignant biliary tract strictures

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 |
| --- | --- | --- |
| Sensitivities with 95% confidence intervals of FISH | Sensitivities with 95% confidence intervals of FISH and routine cytology will be compared | Up to 12 months |
Prognostic Value of Early Postoperative Right Ventricular Systolic Function in Patients With Isolated Severe Tricuspid Regurgitation

Study Overview
=================
Brief Summary
-----------------
Preoperative right ventricular end-systolic area (RV-ESA) and hemoglobin level were suggested as independent prognosticator for predicting long-term prognosis in patients with isolated severe TR undergoing corrective surgery We attempted to explore whether early postoperative echocardiography provides additional prognostic information on top of preoperative clinical and echocardiographic variables.

Detailed Description
-----------------
We prospectively recruited patients with isolated severe TR undergoing corrective surgery. Comprehensive preoperative echocardiography was performed in all patients, with the performance of early postoperative echocardiography in all patients. During follow-up, clinical events, defined as operative mortality (death within 30 days after surgery or before discharge), cardiovascular death, repeated open heart surgery, and readmission due to cardiovascular problems were investigated.

Conditions
-----------------
Tricuspid Regurgitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe tricuspid regurgitation Exclusion Criteria: concomitant left-sided valve surgery significant coronary artery disease

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| tricuspid regurgitation, severe<br>To be included in the present study, the following 3 criteria for severe TR should be met based on the preoperative echocardiography: (1) TR jet > 30% of right atrial area, (2) inadequate cusp coaptation, and (3) systolic flow reversal in the hepatic vein. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical event | Clinical events were defined as operative mortality (death within 30 days after surgery or before discharge), cardiovascular death, repeated open heart surgery, and readmission due to cardiovascular problems. | 40 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tricuspid regurgitation, severe
Quality Improvement PrecivityAD Clinician Survey (QUIP I)

Study Overview
=================
Brief Summary
-----------------
There is an important unmet need for timely, non-invasive, and low-burden evaluation of patients presenting with mild cognitive impairment (MCI) and early dementia. MCI impacts 12-18% of people in the United States over age 60 and is often an initial clinical sign of Alzheimer's disease (AD) (Alzheimer's Association, 2022). The PrecivityAD test is an analytically and clinically validated blood test that aids healthcare providers in the diagnosis of AD in patients with MCI and early-stage dementia. C2N has created a quality improvement (QI) survey to gather insight from clinicians as to the clinical effectiveness of the commercially available PrecivityAD™ test, which identifies whether a patient with signs and symptoms of cognitive decline is likely to have amyloid plaques in the brain, a pathological hallmark of Alzheimer's disease.

Detailed Description
-----------------
By gathering feedback from healthcare providers on patient selection, intended use, and anticipated outcomes and continued or revised care plans as a result of the test report, C2N can better understand the impact of the test results on diagnosis and patient management.

Official Title
-----------------
Quality Improvement Survey I.0: A Retrospective Data Analysis of Clinician Survey Responses Following the Utilization of the PrecivityADTM Blood Test for the Detection of Alzheimer's Disease Pathology (QUIP I)

Conditions
-----------------
Alzheimer Disease, Mild Cognitive Impairment, Dementia, Cognitive Decline

Intervention / Treatment
-----------------
* Other: PrecivityAD blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Memory specialist actively practicing in the United States. Practice includes individuals with mild cognitive impairment age > 60 years Average patient volume > 50 visits per week (all patients seen across practice) Exclusion Criteria: Other clinicians with a specialty outside of the field of Memory Specialists Principal Investigator reserves the right to not include a clinician in the survey

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: PrecivityAD blood test|Clinician Survey post receipt of PrecivityAD blood test result|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate patient selection for the blood test through analysis of clinician survey responses. | retrospective analysis of clinician survey data collected during a single timepoint | 2021 - 2023 | 
| evaluate score interpretation for the Amyloid Probability Score (APS) through analysis of clinician survey responses. | retrospective analysis of clinician survey data collected during a single timepoint | 2021 - 2023 |
Childhood Asthma Mentoring Program for Parents

Study Overview
=================
Brief Summary
-----------------
There are 7.1 million children with asthma. Asthma is the cause of 10.5 million missed days of school, 7.5 million outpatient visits, 640,000 ED visits, and 157,000 hospitalization visits in 2008. Recent work has demonstrated that trained peer mentors (individuals from the community) can be effective in reducing hospitalizations for asthmatic children. This study will evaluate the efficacy of technology-driven parent-to-parent mentoring to reduce asthma-related pediatric hospitalizations and emergency department visits.

Official Title
-----------------
Peer Mentor Training to Reduce Hospitalizations for Children With Asthma

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

Intervention / Treatment
-----------------
* Behavioral: Parent-to-parent mentoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent of child with persistent asthma, prescription of controller medications, and at least one asthma exacerbation in the past year Exclusion Criteria: Parent has no access to smartphone

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parent Mentoring<br>1-on-1, phone, SMS/text, and smartphone-based parent-to-parent mentoring. | Behavioral: Parent-to-parent mentoring<br>* phone, SMS/text, and smartphone-based support<br>|
| No Intervention: Usual Care<br>No intervention through study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospital admissions |  | 1-year | 
| Number of emergency department visits |  | 1-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peer mentor, health coach, parent support, parent mentor
Safety Profile Following Pentabio Vaccination in Indonesian Infants

Study Overview
=================
Brief Summary
-----------------
To assess any serious systemic reaction within 30 minutes after Pentabio immunization

Detailed Description
-----------------
Any local and systemic reaction after Pentabio immunization

Official Title
-----------------
Phase IV, Study of Safety Profile Following Pentabio Vaccination in Indonesian Infants

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Immunization with Pentabio vaccine Parents already understood the consequences to be involved in this study and having signed the informed consent form Parents agree and willing to fill in the Diary Card, to record all the reactions after immunization Exclusion Criteria: Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination except OPV/IPV.

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 11 Months

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 |
| --- | --- |
| Pentabio Vaccine<br>1 dose of Pentabio vaccine, 0.5 ml Will be given intramuscularly | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any serious adverse event occurring from inclusion until 30 minutes after the injection | local and systemic reaction | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of local and systemic events occurring within 72 hours after each injection | any local and systemics events | 72 hours | 
| Percentage of local and systemic events occurring from 72 hours up to 28 days following injection. | any local and systemic events | 25 days | 
| Percentage of serious adverse events within 28 days after injection | Any serious adverse events | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pentabio Vaccine, Safety, Infants, Booster Dose, DTwP/HepB/Hib
A Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
Pilot study to compare the efficacy and safety of 3-day, twice-daily regimens of nitrofurantoin and ciprofloxacin in emergency department (ED) patients presenting with UBC.

Conditions
-----------------
Uncomplicated Bacterial Cystitis

Intervention / Treatment
-----------------
* Drug: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
* Drug: ciprofloxacin 250 mg BID x 3 days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pre-menopausal females ages 18-45 years old symptoms of a UTI (dysuria, frequency, urgency) Exclusion Criteria: Onset of symptoms >7 days prior to the ED visit Non-English speaking Symptoms of pyelonephritis Diabetic Indications of sepsis Immunocompromised Currently using prophylactic antimicrobials Medications that could interfere with study drug Pregnant Lactating History of kidney or liver disease Vaginal symptoms Presence of a urinary catheter Treatment for UBC <2 weeks prior to ED visit Known allergy to study drug Unavailable for follow-up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nitrofurantoin 100 mg<br> | Drug: Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days<br> <br> |
| Active Comparator: Ciprofloxacin 250 mg<br> | Drug: ciprofloxacin 250 mg BID x 3 days<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Cure at Day 7 | Seven days after randomization, subjects received a telephone call to determine if their symptoms have completely resolved. Patients answers were limited to: Yes (clinical cure), No (treatment failure) | 7 days |
Perioperative Analgesia Using Ultrasound (US) Guided Transversus Abdominis Plane (TAP) Block

Study Overview
=================
Brief Summary
-----------------
Perioperative analgesia using US guided TAP block

Detailed Description
-----------------
Perioperative analgesia using US guided TAP block

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Other: TAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult undergoing laparoscopic cholecystectomy Exclusion Criteria: history of cardiorespiratory disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TAP<br>ksu | Drug: Bupivacaine<br>* Local anesthetic<br>Other: TAP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief |  | after US TAP block |