linjc16/ctgov huggingface dataset:
A Study of RO5024048 in Japanese and Caucasian Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This randomized, double-blind, placebo-controlled study will assess the safety, tolerability and pharmacokinetics of RO5024048. Japanese and Caucasian healthy volunteers will be randomized to receive either single oral doses of RO5024048 or placebo. Follow-up is 7-10 days.

Official Title
-----------------
A Multiple Center Randomized, Double-Blind, Single-Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics Following Oral Administration of RO5024048 in Healthy Japanese and Caucasian Subjects

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: RO5024048


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female adults, 20 to 55 years of age, inclusive Body mass index (BMI) 18 - 30 kg/m2 inclusive Non-smoker, or previous smoker who discontinued smoking >/= 6 month prior to study entry Japanese subjects must be first generation: born in Japan, not having lived outside Japan >5 years, able to trace maternal and paternal Japanese ancestry Female subjects of childbearing potential and male subjects and their partners of childbearing potential must agree to use two forms of contraception Agree to abstain from alcohol consumption and from strenuous exercise up to 3 days before dosing and throughout study (including the follow-up visit) Exclusion Criteria: Positive pregnancy test Males whose female partner is pregnant or trying to become pregnant Positive urine test for drugs of abuse Positive for alcohol Positive result on hepatitis B, hepatitis C, or HIV test Clinically significant disease or abnormalities in laboratory parameters Participation in an investigational drug, biologic or device study within 3 months before study drug administration Donation or loss of any blood over 450 mL within 3 months before study drug administration

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: RO5024048<br>* single oral dose<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* single oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of RO4995855 (parent of the prodrug RO5024048) and its metabolite(s) |  | Day 1 to Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability: Adverse events, laboratory parameters, ECG |  | Day 1 to Day 10 |
Prevalence, Persistence, and Risk Factors for Oral Human Papillomavirus (HPV) Infections in College Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how common oral HPV infections are in college women. The investigators also will find out what risk factors are associated with having oral HPV infections. The investigators hypothesize that approximately 3% of women will have oral HPV, and that HPV will be associated with oral sexual behaviors and with smoking behaviors. Finally, for those women with oral HPV- the investigators will determine whether the infections are persistent (still present) at 3-, 6-, and 12-months after the initial diagnosis.

Official Title
-----------------
Prevalence, Persistence, and Risk Factors for Oral HPV Infections in College Women

Conditions
-----------------
Human Papillomavirus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >=18 years Female Currently enrolled as a college student Exclusion Criteria: Unable to provide an oral rinse sample Unable to complete survey Unable to provide contact information Already completed study.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Prevalence of oral HPV | any oral HPV at enrollment | at enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence of oral HPV over 1 year of follow-up | Determine whether HPV remains present at 3-months, 6-months, and 12-months after enrollment | 1 year |
Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole

Study Overview
=================
Brief Summary
-----------------
This is a pilot randomised controlled trial (RCT) to investigate the effect of postoperative face-down positioning on the outcome of macular hole surgery.

Official Title
-----------------
Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole

Conditions
-----------------
Full Thickness Macular Hole

Intervention / Treatment
-----------------
* Procedure: Postoperative face-down posturing
* Procedure: Postoperative non-posturing group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: full thickness macular hole >16 years old Exclusion Criteria: any history of previous intraocular surgery (including cataract surgery) history of ocular trauma history of visual loss greater than 1 year

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Face-down posturing group<br>Postoperative face-down positioning for 10 days after surgery. | Procedure: Postoperative face-down posturing<br>* Postoperative face-down posturing for 10 days after surgery.<br>|
| Active Comparator: Non-posturing group<br>avoid a face-up position for 10 days after surgery | Procedure: Postoperative non-posturing group<br>* avoid a face-up position only for 10 days after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical closure of the macula hole assessed 6 weeks following surgery by ocular coherence tomography. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity assessed 6 weeks following surgery by Snellen charts. |  | 6 weeks |
Oral Cancer Screening Among Nursing Home Dentists in Ohio

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Learning about oral cancer screening practices, knowledge, and opinions of Ohio nursing home dentists may help the study of oral cancer in the future. PURPOSE: This clinical trial is studying oral cancer screening among nursing home dentists in Ohio.

Detailed Description
-----------------
OBJECTIVES: To develop a comprehensive sample of nursing home dentists in Ohio. To document knowledge of oral cancer detection among these dentists. To describe opinions of these dentists about oral cancer screening competency. To describe the current oral cancer screening practices of these dentists. OUTLINE: Participants are stratified according to geographical location (urban vs rural). A comprehensive sample of nursing home dentists practicing in Ohio are contacted through a recruitment letter and are asked to respond to questions regarding oral cancer screening practices, knowledge of oral cancer detection, and opinions about oral cancer screening using a newly developed survey, which is based on parts of an existing, pre-tested instrument (Oral Cancer Prevention and Early Detection Survey).

Official Title
-----------------
Oral Cancer Screening: Practices, Knowledge and Opinions of Ohio Nursing Home Dentists

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Other: survey administration


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Dentist practicing either full-time or part-time in a nursing home setting in the state of Ohio PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: survey administration|Nursing home dentists practicing in Ohio are contacted through a recruitment letter and are asked to respond to questions regarding oral cancer screening practices, knowledge of oral cancer detection, and opinions about oral cancer screening using a newly developed survey, which is based on parts of an existing, pre-tested instrument (Oral Cancer Prevention and Early Detection Survey).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of oral cancer detection among nursing home dentists in Ohio |  | Cross-Sectional | 
| Opinions of these dentists about oral cancer screening competency |  | Cross-Sectional | 
| Current oral cancer screening practices of nursing home dentists in Ohio |  | Cross-Sectional | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lip and oral cavity cancer, oropharyngeal cancer
Promoting Safer Sex in HIV+ Homosexual and Bisexual Men Who Use Methamphetamine

Study Overview
=================
Brief Summary
-----------------
This project studies the effectiveness of a sexual risk reduction intervention among HIV+ Men who have Sex with Men (MSM) and who use methamphetamine.

Official Title
-----------------
Promoting Safer Sex in HIV+ MSM Methamphetamine Users

Conditions
-----------------
HIV Infections, STDs, Methamphetamine Abuse

Intervention / Treatment
-----------------
* Behavioral: Theory-based counseling program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV+ Men who have sex with men Exclusion Criteria:

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Theory-based counseling program|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
-----------------
HIV, STDs, Methamphetamine abuse, MSM
Preop COVID Testing Patterns

Study Overview
=================
Brief Summary
-----------------
This study is an investigation of preoperative asymptomatic COVID screening nationwide. The hypothesis is that because these tests are performed without reference to pretest probability of COVID-19 disease, unlike tests based on symptoms or close contact with infected individuals, these studies may represent a more unbiased sample of the local population prevalence of asymptomatic COVID disease burden.

Detailed Description
-----------------
Study will gather publicly reported, aggregated statistics on positive COVID tests over time and across geographically diverse parts of the United States, summarized weekly, from the onset of the pandemic in Spring 2020 to the present time. Study will also gather contemporaneous data on weekly community COVID cases diagnosed, local positive test percentage, hospital admissions and ICU admissions for COVID-19, and deaths from COVID 19. Similar data will be obtained from a coalition of approximately 20 academic medical centers from around the United States, with Wake Forest School of Medicine, Department of Anesthesiology serving as the coordinating center. No individual patient information will be collected. Aggregated testing data, hospital disease burden, and local disease prevalence are all publicly reported. Data will analyzed as interrupted time series.

Official Title
-----------------
Preoperative COVID Testing as a Predictor of Community Disease Burden

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having preoperative asymptomatic COVID testing > or = 18 years of age Exclusion Criteria: None

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 |
| --- | --- |
| Patients with a preoperative asymptomatic COVID screening test<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of asymptomatic preoperative COVID-19 positive testing |  | March 2020-February 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of hospitalization per geographic area |  | March 2020-February 2021 | 
| Percentage of death per geographic area |  | March 2020-February 2021 | 
| ICU census per geographic area |  | March 2020-February 2021 | 
| Percentage of asymptomatic preoperative COVID-19 positive testing per geographic area |  | March 2020-February 2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Testing, preoperative
Learning Curve for Laparoscopic Distal Pancreatectomy

Study Overview
=================
Brief Summary
-----------------
Laparoscopic distal pancreatectomy (LDP) for benign and borderline pancreatic lesions has recently becoming the treatment of choice in experienced centres. No data have been published about learning curve so far. The purpose of this study was to identify the learning curve period for performing LDP.

Detailed Description
-----------------
Between March 2009 and August 2010 all patients with lesion of body or tail of pancreas were assessed for eligibility for LDP. Exclusion criteria were: major vessels contact in cancer patients, severe organ dysfunction, BMI > 35, and refusing laparoscopic approach. All laparoscopic procedures were carried out by the same surgical team with large experience in open pancreatic surgery. All patients were treated according to an early recovery after surgery protocol. Primary endpoint was conversion rate. Secondary endpoints were operation time, operative blood loss, postoperative morbidity, and length of stay.

Official Title
-----------------
Learning Curve for Laparoscopic Distal Pancreatectomy in a High-volume Hospital

Conditions
-----------------
Pancreatic Lesions Located at Body or Tail.

Intervention / Treatment
-----------------
* Procedure: Laparoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pancreatic lesion located at body or tail Exclusion Criteria: major vessels infiltration severe organ dysfunction refusing laparoscopic approach

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic Distal Pancreatectomy<br> | Procedure: Laparoscopy<br>* Laparoscopic distal pancreatectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion to open surgery |  | during surgery; 3 to 5 hours from the start of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time |  | during surgery; 3 to 5 hours from the start of the procedure | 
| Blood loss |  | during surgery; 3 to 5 hours from the start of the procedure | 
| Length of Hospital Stay |  | Postoperative. From 0 to 30 days after discharge. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
distal pancreatectomy, laparoscopy, learning curve
Stress Level and the Relationship With IVF Outcomes.

Study Overview
=================
Brief Summary
-----------------
The effect of stress on IVF outcomes.

Detailed Description
-----------------
The purpose of this study is to describe the pattern of psychological distress (depression, anxiety and stress) as assessed by both subjective and objective measures throughout the course of IVF treatment and to investigate its impact on IVF outcome.

Official Title
-----------------
Does Stress Affect In-Vitro Fertilization (IVF) Outcome?

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women undergoing IVF at CRMI Ages 20-44 Patients will be divided in different groups depending on whether: They are donating oocytes (control group). They are undergoing IVF for the first time. They are undergoing IVF for the third time and have either failed or succeeded the prior time. Exclusion Criteria: Any patients who are not candidates for IVF Any women who have any past or current medical condition unrelated to their infertility concurrent to their history of infertility (e.g., gastrointestinal disease)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 44 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| First time IVF patients. Observational<br>Those who are doing IVF for the first time. | Other: Observational<br>* Questionnaires are completed such as self-evaluation questionnaire (STAI), Beck Depression Inventory, FertiQol International and Daily stress questionnaire<br>|
| Donors Observational<br>Those who are doing IVF for the sole purpose of donating their eggs. | Other: Observational<br>* Questionnaires are completed such as self-evaluation questionnaire (STAI), Beck Depression Inventory, FertiQol International and Daily stress questionnaire<br>|
| 2 or more IVF cycles Obervational<br>Those who have done IVF 2 or more times with no success. | Other: Observational<br>* Questionnaires are completed such as self-evaluation questionnaire (STAI), Beck Depression Inventory, FertiQol International and Daily stress questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers Cortisol and adrenocorticotropic hormone ACTH. |  | 28-35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaires to be completed are Life Orientation Test-R |  | 28-35 days | 
| Self- Evaluation Questionnaire (STAI) | Questionnaire | 28-35 days | 
| FertiQOL International |  | 28-35 days | 
| Beck Depression Inventory | Questionnaire | 28-35 days | 
| Daily Stress Questionnaire | Questionnaire | 28-35 days |
Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis (PBC)

Study Overview
=================
Brief Summary
-----------------
The goal of this compassionate use program is to provide a mechanism to supply linerixibat, on an individual named patient basis. This program is for treatment of individuals who have moderate/severe cholestatic pruritus associated to PBC who have failed available treatment options and are unable or do not qualify to participate in the linerixibat Phase III clinical studies.

Official Title
-----------------
Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis

Conditions
-----------------
Pruritus

Intervention / Treatment
-----------------
* Drug: Linerixibat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with moderate/severe cholestatic pruritus associated to PBC who are unable to participate or do not qualify for enrollment in the ongoing linerixibat phase 3 clinical trials (NCT04167358 and NCT04950127 studies) Male and female ≥ 18 years of age Participants who have failed available treatment alternatives for cholestatic pruritus in PBC Contraceptive/Barrier Requirements (applicable for female participants only): A female participant is eligible if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using an acceptable contraceptive method during the treatment with linerixibat and for at least 4 weeks after the last dose of linerixibat. Exclusion Criteria: Advanced chronic liver disease (e.g. cirrhosis Child-Pugh C) or presence of hepatic decompensation (e.g. variceal bleeding, encephalopathy). Use of obeticholic acid or other IBAT inhibitor

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Linerixibat|open label investigational product|

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
-----------------
Linerixibat, Individual Patient Compassionate Use, Primary Biliary Cholangitis, Ileal bile acid transporter (IBAT) inhibitor