linjc16/ctgov huggingface dataset:
Human Papillomavirus in Young People Epidemiological Research 3

Study Overview
=================
Brief Summary
-----------------
Anal cancer is overrepresented among gay, bisexual and other men who have sex with men (MSM), particularly those living with HIV. Australia was the first country to introduce a publicly funded national HPV vaccination program in 2007. This program was expanded to include schoolboys aged 12-13 years in 2013; with a 2-year catch-up for boys aged up to 15 years. In 2018, the 9-valent vaccine (covering genotypes 6/11/16/18/31/33/45/52/58) replaced the 4-valent vaccine in the national program. The goal of the HYPER3 study is to determine the prevalence of anal, genital and oral HPV among 200 young gay and bisexual men aged 16-20 years who were eligible for the school-based 9-valent vaccination. Participants will be required to complete a questionnaire and provide samples for HPV testing. No follow-up visits will be required.

Official Title
-----------------
A Cross-sectional Study to Evaluate the Prevalence of HPV in Gay and Bisexual Men Aged 16-20 Years in Australia

Conditions
-----------------
Human Papillomavirus Infection, HPV, HPV Infection, Anal Cancer, Cancer, Men, HPV 16 Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men aged 16 to 20 (i.e. men aged 16-18 years in 2023; men aged 16-19 years in 2024; and men aged 16-20 years in 2025 will be recruited. This is to ensure these men would have been eligible for the 9-valent school-based HPV program) Same-sex attracted Residing in Australia since 2018 Exclusion Criteria: Unable to complete all study requirements in English

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 20 Years

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

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 quadrivalent vaccine HPV types | The oral, penile and anal prevalence of quadrivalent vaccine types (6, 11, 16 and 18) | Baseline | 
| Prevalence of nonavalent vaccine HPV types | The oral, penile and anal prevalence of nonavalent vaccine types (6, 11, 16, 18, 31,33, 45, 52 and 58) | Baseline | 
| Prevalence of type-specific HPV types | The oral, penile and anal prevalence of type-specific HPV types | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccination, Vaccine, Public health, Prevention, Men who have sex with men, Gay and bisexual men, Immunisation
Effects of Marijuana Used on Lung Function in Persons With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The main hypothesis is that persons that smoke or smoked tobacco and marihuana have worsen lung function as compared with persons that only smoke or smoked tobacco.

Detailed Description
-----------------
We will follow persons with already diagnosed COPD (chronic bronchitis and/or emphysema). Obtain their smoking history: tobacco and marihuana and review their pulmonary function study results. Then we are planning to compare both groups.

Official Title
-----------------
Effects of Marijuana Smoking on Pulmonary Function in Patients With COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients former or current tobacco smokers COPD patients former or current tobacco and marihuana smokers Exclusion Criteria: History of COPD without pulmonary function testing Refusal to provide smoking or marihuana used history

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 90 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 |
| --- | --- |
| COPD tobacco and/or marihuana users<br>COPD patients with history of tobacco and/or marihuana smoking. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obstructive limitation in pulmonary function test | Comparison on the severity of obstruction among both groups | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased diffusion capacity for carbon monoxide | Comparison on the severity of decreased DLco among groups. | 1 year | 
| Airtrapping | Comparison on the severity of air-trapping by pulmonary function testing among groups. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, pulmonary function, tobacco and marihuana smoking
Accuracy of CNAP PPV Under General Anaesthesia

Study Overview
=================
Brief Summary
-----------------
Noninvasive pulse pressure variation for the guidance of perioperative fluid therapy is compared with the gold standard of invasive measurements. Cardiac output is derived by the PICCO monitor. Hypothesis: Noninvasive CNAP PPV predicts fluid responsiveness. A grey zone for the prediction of fluid responsiveness will be defined.

Detailed Description
-----------------
Accuracy of PPV measured by two devices,PICCO and CNAP, is compared with the manually calculated PPV from the arterial line waveform. Established tests like passive leg raising and end-expiratory occlusion are used for prediction of fluid responsiveness. Intraoperative events like volume challenge are monitored.

Official Title
-----------------
Comparison of the Non-invasive CNAP Pulse Pressure Variation With the Invasive Gold Standard

Conditions
-----------------
General Anaesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: major surgery need for invasive arterial measurements Exclusion Criteria: age under 18 cardiac dysrhythmia vascular pathology at punction site

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Cardiac output | Improvement of cardiac output dependent on PPV before volume challenge | 1, 2, 5, 10, 15 and 20 minutes after volume challange and |
Familial Cancer Registry and DNA Bank

Study Overview
=================
Brief Summary
-----------------
Clinical cancer genetics is an emerging new field in medical oncology, and has been incorporated into routine oncology practice in many leading medical institutions in North America and Europe. Cancer genetics is the study of genetic factors contributing to carcinogenesis. In the last 5-10 years, genes responsible for various well-defined hereditary cancer syndromes have been cloned. These include the BRCAJ/2 genes in hereditary breast and ovarian cancer syndrome, the A4PC gene in Familial Adenomatous Polyposis, and the mismatch repair genes (hMLH1, hMSH2, hPMS1, hPMS2, hMSH6) in hereditary non-polyposis colorectal cancer (HNPCC). One of the goals of a clinical cancer genetics service is to identify families at risk for hereditary cancer syndromes, provide genetic counseling, and offer genetic testing when appropriate. The identification of causative genes in hereditary cancer syndromes together with the advent of genetic testing is starting to have an impact on clinical management. The ability to identify a gene mutation in a cancer family allows predictive testing, stratifying at-risk family members into carriers who will benefit from aggressive surveillance and/or preventive options, and non-carriers who may be spared unnecessary surveillance. Appropriate use of genetic testing will ultimately result in medical cost reduction. The investigators hypothesize that the clinical characteristics and genetic factors contributing to hereditary cancer in the Singaporean Asian population are distinct from those described for Western patients.

Official Title
-----------------
Familial Cancer Registry and DNA Bank

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any individual with very early onset cancer (eg diagnosed before age 40). Any family with three or more first- or second-degree relatives with the same cancer Any individual with two or more different primary cancers Any family that fulfils diagnostic criteria for known hereditary cancer syndromes Exclusion Criteria: Nil

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- |
| Cancer patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in genetics testing method |  | 2 years |
CORONADO (Circulating tumOur pROtein quaNtification cApillary blooD cOvid-19)

Study Overview
=================
Brief Summary
-----------------
The coronavirus (COVID-19) pandemic has brought severe challenges for myeloma patients. Myeloma patients are considered ultra-high risk for COVID-19 and fall into the strictest group for shielding. When on treatment, but also during times of active surveillance, patients have to regularly and frequently leave shielding and visit the hospital for blood tests to monitor their disese. This is specifically for quantification of circulating tumour protein biomarker tests for paraprotein (PP) and/or serum free light chains (sFLCs) by specialised biochemistry units. This research aims to evaluate the potential use of an at-home patient administered technique to sample blood. The purpose of the blood sampling technique is to monitor your disease status. We want to test if it is possible to monitor a patient's disease status using this alternative blood collection method when compared to monitoring disease status using the traditional blood collection methods (venous blood sampling). The new VAMS method is not intended to be used interchangeably or will not replace the current method. This study is to evaluate an alternative sample type that may be used to improve the patient pathway, especially during these uncertain times.

Official Title
-----------------
Circulating Tumour Protein Quantification From Capillary Blood for Patient Selfsampling and Safe Remote Monitoring of Multiple Myeloma During COVID-19

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Other: n/a - samples collected along routine care samples only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of a B-cell dyscrasia Measurable disease by serum free light chain assay Signed informed consent Exclusion Criteria: Patients <21 years of age Cognitive impairment Non-B Cell Dyscrasia patients

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: n/a - samples collected along routine care samples only|This is a non-interventional study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validated FLC | Validated FLC method for use with VAMS that conforms to ISO15189:2012 accreditation | 6 months |
Glasgow-Blatschford Score Validation in Digestive Hemorrhage

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate the Glasgow-Blatchford score for the stratification of patients with upper gastro-intestinal hemorrhage. This score is easy to calculate. It is mainly based on the hemoglobin, blood pressure and blood urea. if the score is zero, the bleeding is very low risk and the gastrointestinal endoscopy may be delayed and performed as an outpatient.

Official Title
-----------------
Glasgow-Blatschford Score Validation for Stratification of Patients With Digestive Hemorrhage

Conditions
-----------------
Gastrointestinal Hemorrhage

Intervention / Treatment
-----------------
* Procedure: Endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be admitted in the university hospital for a gastrointestinal hemorrhage (vomiting of red or black blood or melena) Exclusion Criteria: Age under 18 Pregnancy Hemorrhage during hospitalisation red rectal bleeding No consent signed

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Endoscopy<br>If the Glasgow-Blatchford score is zero, the endoscopy is delayed as an outpatient | Procedure: Endoscopy<br>* Realization of an upper GI endoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of length of stay between patients with score equal to zero and above zero |  | june 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the proportion of low risk upper gastrointestinal bleeding |  | june 2010 |
Pharmacokinetics And Safety Study Of Two CP-690,550 Controlled Release Formulation Following Single Dose In Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will explore the drug behavior and safety following single dose of two 20 milligram CP-690,550 osmotic capsules in 12 healthy volunteers. These will be compared to a 10 milligram immediate release tablet, using a 3 way crossover design.

Official Title
-----------------
A Phase 1, Randomized, 3-Period, Open Label, Single Dose, Cross Over Study To Evaluate The Pharmacokinetics And Safety Of Two Controlled Release Formulations Of CP-690,550

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

Intervention / Treatment
-----------------
* Drug: CP-690,550


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. Clinically significant infections within the past 3 months.

Ages Eligible for Study
-----------------
Minimum Age: 21 Months
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Subjects will receive in random order, the immediate release tablet containing 10 mg of CP-690,550 and two different controlled-release capsules containing 20 mg of CP-690,550. | Drug: CP-690,550<br>* Single doses separated by a minimum of 72 hour washout between treatments<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters: AUCinf(dn), Frel and Cmax(dn) of CP-690,550 |  | 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters: AUCinf, AUClast, AUClast(dn), Cmax, Tmax, t½, C12h, C24h of CP-690,550 |  | 9 days | 
| Safety: laboratory tests, adverse events reporting, ECG and vital signs |  | 9 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relative bioavailability, controlled release, Phase 1, CP-690, 550
The Preventive Effect of Helicobacter Pylori Eradication on the Development of Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Recently, the preventive effect of Helicobacter pylori (Hp) eradication treatment on the incidence of gastric cancer has been reported. By Hp eradication treatment being performed for Hp-infected people in Iijima town, we will evaluate whether the incidence of gastric cancer and/or the medical care cost can be reduced as compared with those in the previous years.

Official Title
-----------------
The Effect of Helicobacter Pylori Eradication on the Development of Gastric Cancer and the Medical Care Cost in Iijima Town

Conditions
-----------------
Helicobacter Pylori, Eradication, Gastric Cancer, Medical Care Cost

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People who live in Iijima town at their age of 19 to 69 years

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 69 Years

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 |
| --- | --- |
| 1<br>HP eradication group | |
| 2<br>No eradication group | |
| 3<br>No Hp group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the annual incidence of gastric cancer in Iijima town |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The annual medical care cost in Iijima town |  | 10 years |
Chronic Kidney Disease & Therapeutic Exercise

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the therapeutic exercise effects in patients with chronic kidney disease. An interventional prospective study is carried out. A sample of 9 patients with chronic kidney disease is recruited. The kidney function (creatinine clearance as main outcome) is measured at baseline and 1 month after treatment start.

Official Title
-----------------
Therapeutic Exercise in Patients With Chronic Kidney Disease

Conditions
-----------------
Exercise, Kidney

Intervention / Treatment
-----------------
* Other: Therapeutic exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic kidney disease Exclusion Criteria: Cognitive impairment and non signed consent inform form.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Therapeutic exercise<br> | Other: Therapeutic exercise<br>* 30 minutes per day of therapeutic exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney function | Creatinine clearance | Change from Baseline creatinine clearance at 1 month |
An Arts-Based Initiative for the Prevention of Violence Against Women and Girls

Study Overview
=================
Brief Summary
-----------------
this project will evaluate a community and school based program to promote healthy relationships and prevent violence (physical, emotional and sexual dating violence) among predominately African American middle school adolescents in an urban setting (Baltimore, MD).

Detailed Description
-----------------
This initiative includes 4 major components: 1) A variety of arts based student activities related to violence prevention (during and after school theatre projects, during and/or after school visual arts project, and the web page design project. (All students will either directly participate in these activities or at least see them), 2) Curricular components for all 7th graders, 3) Violence prevention and early intervention student support/discussion groups, and 4) Faculty and staff training on the subject. The evaluation is a quasi-experimental pre/post test comparison group design (2 schools in each group), where our comparison schools convert to intervention schools one year after serving as comparison schools. We are using both group (student and teacher surveys) and school wide (climate of the school) measures pre and post intervention.

Official Title
-----------------
An Arts-Based Initiative for the Prevention of Violence Against Women and Girls

Conditions
-----------------
Violence

Intervention / Treatment
-----------------
* Behavioral: Arts Based Program
* Behavioral: Curriculum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Students in four middle schools in urban Baltimore, MD (Dunbar, Lombard, Calverton and Lemmel Middle Schools) Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 14 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Arts Based Program|nan|
|Behavioral: Curriculum|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dating violence perpetration |  | past 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dating violence victimization |  | past 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dating violence, violence against women