linjc16/ctgov huggingface dataset:
HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women

Study Overview
=================
Brief Summary
-----------------
The proposed study will examine the implementation of a Human Papilloma Virus (HPV) self-sampling intervention for under screened LBQ women living in South Florida. The study will enroll participants to receive the self-sampling intervention in community venues. The purpose of this study is to pilot the self-sampler for feasibility and acceptability within this underserved population.

Official Title
-----------------
HPV Self-Sampling for Cervical Cancer Screening Among Lesbian, Bisexual, and Queer (LBQ) Women: A Pilot Study

Conditions
-----------------
Cervical Cancer Screening

Intervention / Treatment
-----------------
* Behavioral: HPV self-sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-identify as lesbian, bisexual, or queer woman Assigned female sex at birth English speaking ages 25-65 years report not having had a pap smear in the last three years (per USPSTF guidelines) if age 30 or over, report not having a pap smear/HPV co-test within the past 5 years (per USPSTF guidelines) Exclusion Criteria: report having had a hysterectomy report having history of cervical cancer unable to consent Pregnant women Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HPV Self-sampling<br>All participants will receive HPV self-sampling intervention. HPV self-sampling is a cervical cancer screening that can be done in private, using a device that is similar to a tampon. This intervention tests for high-risk HPV, the primary cause of cervical cancer. Each participant will complete the intervention one time only. | Behavioral: HPV self-sampling<br>* All participants will receive HPV self-sampling intervention. HPV self-sampling is a cervical cancer screening that can be done in private, using a device that is similar to a tampon. This intervention tests for high-risk HPV, the primary cause of cervical cancer. Each participant will complete the intervention one time only.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV Self-sampling uptake | Percentage of eligible women who complete HPV self-sampling | through study completion, up to 1 year |
Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose

Study Overview
=================
Brief Summary
-----------------
This study is to investigate the persistence of rabies Chinese manufactured antibody 1-5 years after the post-exposure prophylaxis with vero cell antirabies vaccine and antibody response to a single booster dose. A total of 160 subjects would be enrolled. These subjects were all administered ChengDa antirabies vaccine from 2005 to 2009. After informed consent is obtained, these subjects would be tested for their antirabies antibody titer and given a single booster dose. Seven and 14 days later, the investigators would re-evaluate the antibody titer.

Official Title
-----------------
Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose

Conditions
-----------------
Rabies

Intervention / Treatment
-----------------
* Biological: Rabies vaccine, manufactured by ChengDa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 to 60 years old Healthy Given ChengDa rabies vaccine Good compliance Obtained informed consent Exclusion Criteria: Other than inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post vaccination<br>All the subjects had been vaccinated with antirabies vaccine. | Biological: Rabies vaccine, manufactured by ChengDa<br>* 1 dose before the antibody is tested<br>* Other names: ChengDa Speeda;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rabies antibody titer | We test the antirabies antibody titer before and after the single booster dose | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rabies, Anti-rabies antibody, Persistence
PEEP Recruitment-comparison Between Ultrasonographic Assessment and LIP Assessment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare lung recruitment in acute lung injury (ALI)/acute respiratory distress syndrome (ARDS) based on lower inflection point with transthoracic ultrasonographic assessment of lung recruitment.

Detailed Description
-----------------
Sedated and sometimes temporary relaxed patients with ALI/ARDS on mechanical ventilation in semirecumbent position are included. Lower inflection point on pressure volume loop on ventilator Draeger Evita 4 with low continuous flow on volume controlled ventilation is measured with zero PEEP. Transthoracic lung ultrasound with linear probe is proceed on both hemithoraces when mechanical ventilation based on measured PEEP is started. We compare if real lung recruitment seen by ultrasound is the same as predicted by lower inflection point. The procedure is a part of routine everyday respiratory monitoring in our unit.

Official Title
-----------------
Positive End-expiratory Pressure Induced Lung Recruitment -Comparison Between Ultrasonographic Assessment and Lower Inflection Point Assessment on the Pressure -Volume Loop

Conditions
-----------------
Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with diffuse ALI/ARDS on mechanical ventilation with visible lower inflection point on dynamic P-V loops Exclusion Criteria: preexisting parenchymal or pleural lung disease

Ages Eligible for Study
-----------------
Minimum Age: 16 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
-----------------
lung ultrasonography, pressure-volume loops, ARDS
Identifying Barriers and Strategies to Support Self-efficacy for Medication Adherence With Text Messaging

Study Overview
=================
Brief Summary
-----------------
The investigators will explore barriers to improving self-efficacy, or the ability to feel in control of their disease, and medication adherence with text messaging through surveys and interviews with adolescents and adults with SCD cared for at the Vanderbilt Meharry Center of Excellence (VMCE) in Sickle Cell Disease (SCD). The investigators will identify preferences to improve and sustain adherence to daily medication through selection of investigator-proposed or patient-generated text messaging strategies. Finally, the investigators will fill in the literature gaps by describing barriers to self-efficacy and medication adherence among adults with SCD as well as adolescents with SCD who are transitioning to adult care.

Official Title
-----------------
Identifying Patient-centered Barriers and Preferred Strategies to Support Self-efficacy for Medication Adherence With Two-way Text Messaging

Conditions
-----------------
Sickle Cell Disease

Intervention / Treatment
-----------------
* Other: Interviews and Surveys


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving care at the VUMC/Matthew Walker clinic Diagnosed with SCD, asthma, or both Currently taking daily medications for SCD, such as hydroxyurea, asthma, or both Having access to a mobile telephone and/or computer Age 12-70 years Exclusion Criteria: 1. Unable to perform interviews or surveys

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 70 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 |
| --- | --- |
| Asthma and/or Sickle Cell Anemia<br>The investigators will examine patients with sickle cell disease, asthma, or both who are aged 12-70 years who take daily medications. | Other: Interviews and Surveys<br>* The investigators will perform semi-structured interviews and surveys on this cohort<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with barriers to medication adherence | High cost, forgetting, side effects, access to medications | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients that prefer a tailored text messaging technological solution |  | 1 year |
Comparison of Body Dissatisfaction Among Islamic Veil Practicing (IVP), Non-Complete IVP, and Inconsiderate to IVP Women

Study Overview
=================
Brief Summary
-----------------
The aim of this research is to examine the social, psychological and Islamic veil practicing (IVP), non-complete IVP and Inconsiderate to IVP correlates of body mass index (BMI) status in a women population. It is hypothesized that women who are IVP would differ on depression, and social variables compared with their non-practicing peers.

Detailed Description
-----------------
In this cross-sectional study, a population-based sample of 1774 female responded anonymously to an aerobic health club administered questionnaire. Body mass index was calculated from height and weight and categorized into four classes of underweight, normal, overweight, and obese. The questionnaire also included questions about social experiences, body dissatisfaction as Body Shape Questionnaire (BSQ), future goals and Islamic Veil Practicing (IVP). Persian version of Beck Depression Inventory (BDI-II Persian) and Rosenberg Self Esteem Scale was also distributed among six groups of women having IVP/regular exercise (RE), IVP/non-RE, Non-complete IVP/RE, Non-complete IVP/non-RE, Inconsiderate to IVP/RE, and Inconsiderate to IVP/non-RE. Correlations of BMI with social, psychological, future goals and IVP were explored

Official Title
-----------------
Comparison of Body Dissatisfaction Among Islamic Veil Practicing (IVP), Non-Complete IVP, and Inconsiderate to IVP Women

Conditions
-----------------
Depression, Body Dissatisfaction, Obesity, Eating Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Open for all women practicing Islamic veil, Non-complete IV, or Inconsiderate to IV Exclusion Criteria: Overt signs of Anorexia Nervosa, Bulimia Nervosa

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 59 Years

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Self Concept, Eating Disorder, Body Mass Index, Dressing, Islamic Veil
Effects of CX516 on Functioning in Fragile X Syndrome and Autism

Study Overview
=================
Brief Summary
-----------------
This study will investigate whether CX516 can improve attention, memory, language, or behavior in adults with Fragile X Syndrome and/or Autism. CX516 is an AMPAKINE® compound. AMPAKINE compounds enhance synaptic strength. There is evidence to suggest that the synapses in the brain of an individual with fragile X syndrome are immature and abnormal. It is possible CX516 may partially correct this synaptic transmission defect and lead to improvement in cognitive and behavioral functioning. There is also reason to believe that these changes caused by CX516 could be helpful in managing cognitive and behavioral symptoms in patients with autistic disorder. Involvement for each participant will last 28 days. Participants will be given study medication, a physical exam, and a variety of cognitive assessment tests to study potential drug effectiveness at improving disease symptoms.

Official Title
-----------------
Effects of Ampakine CX516 (Ampalex®) on Functioning in Fragile X Syndrome and Autism

Conditions
-----------------
Fragile X Syndrome, Autism

Intervention / Treatment
-----------------
* Drug: CX516 (Ampalex®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Fragile X group DNA-based diagnosis of Fragile X syndrome Autism group Documented diagnosis with ADOS; ADI-R; CARS and GARS Both groups 18-50 years Measured IQ below 85 Measured IQ >20 Mental age >30 months Stable medication regimen for past 8 weeks Normal hearing Vision corrected to at least 20/50 All females of childbearing age must have a negative pregnancy test at enrollment Exclusion criteria: Recent history of seizure, epilepsy, or blackouts Unresolved medical issue impacting performance Behavioral dysfunction to the point that subject cannot cooperate for testing History of drug-induced neutropenia Uncontrolled hypertension

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CX516 (Ampalex®)|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
-----------------
Fragile X Syndrome, Autism
Clinical Performance of NIPT in Multiple Gestation Pregnancies

Study Overview
=================
Brief Summary
-----------------
This study plans to evaluate the clinical performance of the MaterniT21 PLUS and/or GENOME Laboratory Developed Test, in the detection of fetal trisomy 21 in circulating cell-free DNA extracted from maternal blood samples obtained from women pregnant with a twin gestation.

Official Title
-----------------
Clinical Performance of NIPT (Noninvasive Prenatal Testing) in Multiple Gestation Pregnancies (SCMM-T21-110)

Conditions
-----------------
Trisomy 21 in Fetus

Intervention / Treatment
-----------------
* Device: MaterniT21 PLUS and GENOME Laboratory-Developed Tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subject pregnant with a multiple gestation and received NIPT from Sequenom Laboratories; subject was 18 or older at the time of NIPT Exclusion Criteria: none

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnancies with multiple gestations<br> | Device: MaterniT21 PLUS and GENOME Laboratory-Developed Tests<br>* Both the MaterniT21 PLUS and GENOME are intended for use as laboratory developed test that analyze ccfDNA extracted from a maternal blood sample utilizing Massively Parallel Sequencing (MPS) technology.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of sensitivity of NIPT detection of trisomy 21 among a population of women with twin gestations. |  | time from maternal blood draw to delivery | 
| Determination of specificity of NIPT detection of trisomy 21 among a population of women with twin gestations. |  | time from maternal blood draw to delivery |
Biliary Externalization After Pancreaticoduodenectomy

Study Overview
=================
Brief Summary
-----------------
Postoperative pancreatic fistula(POPF) is the most common complication of pancreaticoduodenectomy (PD). Sometimes POPF is associated with biliary fistula(BF), or mixed fistula. The purpose of this study is to assess whether the severity of the fistulae, when present, is decreased with an external biliary stent in place.

Detailed Description
-----------------
n this single-center study we analyze patients who underwent elective PD from January_2014 to December_2017. Patients are divided into two groups: standard PD (ST-PD)vs PD with external biliary stent(PD-BS). Demographic, preoperative, intraoperative, and postoperative variables will be analyze, including complications according to the Clavien-Dindo classification, and those specific to pancreatic surgeries, and mortality rates within 90 days of operation.

Official Title
-----------------
Prospective Study Correlating External Biliary Stenting and Pancreatic Fistula Following Pancreaticoduodenectomy

Conditions
-----------------
Postoperative Complications

Intervention / Treatment
-----------------
* Procedure: External biliary stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent Patient age > 18 years old; Elective pancreaticoduodenectomy performed for primary pancreatic disease. Exclusion Criteria: Pancreaticoduodenectomy with multivisceral resection (organ other than duodenum, pancreas, gallbladder, and bile duct); Patients with peritoneal or liver metastases found during surgery.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| standard PD (ST-PD)<br>Pancreacoduodenectomy with pancreatic-enteric reconstruction and standard hepaticojejunostomy | |
| PD with external biliary stent(PD-BS)<br>Pancreacoduodenectomy with pancreatic-enteric reconstruction and hepaticojejunostomy with external biliary stent for externalization of bile fluid | Procedure: External biliary stent<br>* The biliary stent consisted of a multi-perforated, natural rubber tube, measuring 3.5 mm in diameter, that we placed transanastomotically, with exteriorization sited at 20 cm utilizing the Witzel jejunostomy approach<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Any postoperative complications | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreaticoduodenectomy, Pancreatic postoperative fistula
Fecal Microbiota Transplant National Registry

Study Overview
=================
Brief Summary
-----------------
A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness

Detailed Description
-----------------
This registry will prospectively enroll 4,000 patients who undergo FMT at 75 sites throughout North America. Information on FMT methodology employed (e.g., screening of donor and recipient, preparation, FMT delivery) will be collected from each site. The indication for FMT as well as baseline information on recipient will also be collected. Following FMT, patients will be followed at regular intervals up to 10 years post FMT. This will include follow-up information from the patient's healthcare provider at 1 month, 6 months, 1 year, and 2 years after FMT as well as direct communication with patients at least annually up to 10 years after FMT. Follow-up information collected will be designed to assess potential short-term and long-term safety and effectiveness.

Official Title
-----------------
Fecal Microbiota Transplant National Registry

Conditions
-----------------
Fecal Microbiota Transplantation, Clostridium Difficile Infection, Gut Microbiome

Intervention / Treatment
-----------------
* Other: None - Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recipient Inclusion Criteria Ability to give informed consent Receiving FMT or other gut-related microbiota product within 90 days after providing consent Access to internet and/or telephone Donor Inclusion Ability to give informed consent Providing stool sample for FMT Exclusion Criteria: Incarceration
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: None - Observational|None - Observational|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of treatment related Adverse Events | Adverse events to be monitored include surgeries, infection, hospitalization, other life-threatening events, death and newly diagnosed diseases. | over 10 Years | 
| Disease Re-occurrence Following FMT | Assess effectiveness of FMT by monitoring disease re-occurrence post treatment. | over 10 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FMT, CDI, Fecal Matter Transplant