linjc16/ctgov huggingface dataset:
Human Papillomavirus in Young People Epidemiological Research 4

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. The goal of the HYPER4 study is to determine the prevalence of anal, genital and oral HPV among 500 young gay and bisexual men aged 21-25 years who were eligible for the school-based gender-neutral quadrivalent vaccination program. 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 21-25 Years in Australia

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men aged 21 to 25 years old in 2023-2024 Same-sex attracted Residing in Australia since 2013 Exclusion Criteria: Unable to complete all study requirements in English

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 25 Years

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

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 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
How Improvement in Control of Diabetes Influences the Production of a Hormone Produced in the Gut Which Improves the Release and Action of Insulin.

Study Overview
=================
Brief Summary
-----------------
The study is aimed at Type 2 Diabetics who are taking Metformin, but whose Diabetes remains poorly controlled. There are two additional medications already in use, Glimepiride and Sitagliptin will be compared to assess levels of improvement in Diabetes control.

Official Title
-----------------
Influence of Improving Glycaemic Control on Glucagon-Like-Peptide-1 Response to an Oral Glucose Load. Comparison of Sulphonylurea With DPP-4 Inhibition.

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Glimepiride
* Drug: Sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes Mellitus Currently on Metformin but poor glycaemic control, Exclusion Criteria: Under 18 years of age

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Glimepiride<br>* 3mg oral tablet.<br>* Other names: Amaryl.;|
| Active Comparator: 2<br> | Drug: Sitagliptin<br>* 100mg oral tablet.<br>* Other names: Januvia.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of GLP-1 response at baseline and after 3 months treatment of both groups. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, GLP1, DPP4
Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Investigators have developed a comprehensive questionnaire that assesses the presence of non-motor fluctuations (NMFs) in individuals with Parkinson's disease (PD). To date, 189 participants with PD have been assessed for preliminary data analysis prior to developing the penultimate version. At this time the objectives are to: (i) assess the scale's internal consistency and item-to-total correlations; (ii) assess test-retest reliability; (iii) use factor analysis and reliability measures to guide item reduction; (iv) assess construct validity; and (v) assess the scales ability to discriminate between static non-motor symptoms and non-motor symptoms which fluctuate (vi) estimate the relative distribution of cognitive, psychiatric, autonomic, sleep and sensory NMFs in PD patients with motor fluctuations and their impact on quality of life in Parkinson's disease.

Official Title
-----------------
Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Idiopathic Parkinson's Disease (according to the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria) Stage of symptoms is mild, moderate or severe as per the Hoehn & Yahr scale Have motor fluctuations Have non-motor fluctuations Exclusion Criteria: Atypical Parkinsonism Lack of motor fluctuations Lack of English language proficiency in either subject or caregiver
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cronbach's Alpha | alpha 0 - 1.0 | Baseline | 
| Item-to-total correlation | correlation -1.0 - 1.0 | Baseline | 
| Inter-rater reliability | kappa 0 - 1.0 | 1 week after Baseline | 
| Concurrent validity | correlation -1.0 - 1.0 | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-motor fluctuation
CRRTNet Registry- A Prospective Observational Registry

Study Overview
=================
Brief Summary
-----------------
An observational registry to monitor the outcome of CRRT in adults with acute kidney injury.

Detailed Description
-----------------
Continuous Renal Replacement Therapy (CRRT) is a form of dialysis provided to critically ill patients with acute renal failure, now known as acute kidney injury (AKI). While we have extensive experience with this therapy in critically ill patients, there is no consensus on when to start CRRT or a clinical standard as to the best possible way to deliver the therapy. Previous studies have examined one aspect of CRRT in detail (for instance the dose of delivered therapy, or anticoagulation strategies) or have been small single center studies, or large multinational studies examining very basic practice patterns. This is a prospective observational cohort study. All patients who receive CRRT as part of their standard of local care will be eligible for the study.

Official Title
-----------------
CRRTNet Outcome Registry

Conditions
-----------------
Continuous Renal Replacement Therapy

Intervention / Treatment
-----------------
* Procedure: Continuous Renal Replacement Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients initiating CRRT c. Age > 18 years of age and <89 year of age - Exclusion Criteria: ˂ 18 years of age and > 89 year of age -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| Acute Kidney Injury<br>CRRT intervention with adult patients with Acute Kidney Injury | Procedure: Continuous Renal Replacement Therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRRT, Renal, Kidney, adults, registry, AKI
Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy

Study Overview
=================
Brief Summary
-----------------
to determine the safety, efficacy and tolerability of transdermal fentanyl in patients undergoing mastectomy, as well as the postoperative consumption of analgesic.

Official Title
-----------------
Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy

Conditions
-----------------
Breast Cancer Female

Intervention / Treatment
-----------------
* Drug: The Transdermal Therapeutic System-Fentanyl (TTS-F)
* Device: Intravenous patient-controlled analgesia (PCA) morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I - II patients aged 30-60 years body weight ranged between 65-10kg Exclusion Criteria: Patients with history of allergy to morphine chronic intake of analgesics or non-steroidal anti-inflammatory drug 24 h prior to surgery, there was a history of a psychiatric disorder patients weight was less then 50kg. impaired kidney function.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The Transdermal Therapeutic System-Fentanyl (TTS-F) group<br>(TTS-F) group (n=30) 50ug/h patch, placed 12 hs preoperatively. | Drug: The Transdermal Therapeutic System-Fentanyl (TTS-F)<br>* (TTS-F) group (n=30) 50ug/h patch, placed 12 hours preoperatively<br>* Other names: Fentanyl patch;|
| Placebo Comparator: Intravenous patient-controlled analgesia (PCA) morphine<br>IV (PCA) morphine for pain in the postoperative period. | Device: Intravenous patient-controlled analgesia (PCA) morphine<br>* IV PCA morphine for pain in the postoperative period.<br>* Other names: IV PCA morphine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of morphine consumption in the first 48 hours postoperative | Total dose of I.V. PCA morphine consumption in the first 48 hours postoperative | 48 hours | 
| Visual Analogue Scale | Pain measurement scale | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of stress hormones | Cortisol levels | 48 hours | 
| Side effects related to the opioids | Nausea and vomiting; Itching; Respiratory depression. | 48 hours |
Psychosocial Training for Pediatric Health Care Providers

Study Overview
=================
Brief Summary
-----------------
This study will provide psychosocial training to general health care providers to help them provide better care to children with mental health problems.

Detailed Description
-----------------
Up to 20% of school-age children have one or more mental health conditions that require treatment. These conditions are often treated by generalists. However, a significant proportion of children who seek treatment from generalists do not receive effective treatment. Studies indicate that generalists who treat adults can improve the administration of treatment after taking part in training programs, but these studies have yet to be translated into pediatric settings. This study will conduct a training program to help generalists provide effective treatments to children with mental health problems. This study will evaluate a two-session, highly interactive training program in which general clinicians receive psychosocial training. The training program includes skills related to engaging parents and children, problem identification, solution-focused cognitive therapy, and making effective mental health referrals. The child's mental health symptoms, functioning, changes in utilization of pediatric services, and utilization of community services will be measured along with the mother's emotional well-being and family functioning.

Official Title
-----------------
Trial of Psychosocial Training for Pediatric Generalists

Conditions
-----------------
Mental Disorders Diagnosed in Childhood

Intervention / Treatment
-----------------
* Behavioral: Mental health communication skills training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Health Care Providers: Generalist clinician in primary care practice seeing children 6 to 16 years of age Inclusion Criteria for Patients: 6 to 16 years of age Seeing a study-enrolled provider English or Spanish speaking Not in acute pain

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Mental health communication skills training|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
-----------------
Child, Adolescent
Study of Novel Types of Familial Diabetes Insipidus

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Define the phenotype and genotype of previously unrecognized types of familial diabetes insipidus (FDI) in kindreds with atypical or novel forms of FDI.

Detailed Description
-----------------
PROTOCOL OUTLINE: Participants undergo a series of tests to determine the presence, absence, cause, natural history, clinical status, and mode of inheritance of their type of diabetes insipidus (DI). The studies include measurements of basal fluid intake and urine output, plasma vasopressin during standard fluid deprivation or waterload/saline infusion tests, and changes in water balance during a therapeutic trial of DDAVP. If clinically indicated, echocardiograms and assays of plasma catecholes and renin are also completed. Linkage analysis is performed for all participants; kindreds with the Marfan-like syndrome are also studied for the fibrillin-1 genotype. Participants determined to have DI are treated with desmopressin for 2 days.

Conditions
-----------------
Diabetes Insipidus

Intervention / Treatment
-----------------
* Drug: desmopressin


Participation Criteria
=================
Eligibility Criteria
-----------------
Familial diabetes insipidus (DI) in atypical or novel form, e.g.: Dipsogenic DI Neurohypophyseal DI Affected and unaffected members of kindreds eligible

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: desmopressin|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
-----------------
diabetes insipidus, endocrine disorders, rare disease
Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)

Study Overview
=================
Brief Summary
-----------------
The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficient of r=0.75 indicating strong correlation between the AHI of diagnostic PSG and AL.

Detailed Description
-----------------
All subjects with suspected Sleep Disordered Breathing (SDB) scheduled for diagnostic polysomnography (PSG) will be invited to participate in the study to be tested to determine if they have Sleep Disordered Breathing (SDB), using the ApneaLink (AL) Sleep Screener. Subjects initially will be tested for SDB in the home environment. Following an AL home test, subjects will undergo a simultaneous, attended diagnostic polysomnography (PSG) sleep study and ApneaLink test for the purpose of confirming and comparing the results between diagnostic PSG and the AL device.

Official Title
-----------------
Validation of the ApneaLink Sleep Screener in a Suspected Sleep Disordered Breathing Population

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: ApneaLink Sleep Screener


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects ( greater than 18 years of age) of either gender or any race Suspected sleep disordered breathing Untreated sleep disordered breathing Willingness to use AL at home within 2 days of receipt and instruction on the AL Willingness to use AL at home and undergo PSG within 2 to 4 weeks of completing the at home AL test Exclusion Criteria: Any subject requiring home oxygen therapy Any subject currently receiving positive airway pressure therapy

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ApneaLink Sleep Screener|Device used to evaluate for the presence of OSA|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity | Comparison of sensitivity and specificity of ApneaLink to polysomnography with an apnea hypopnea index (AHI) cut-off of 15 or greater | Simultaneous single night recording |
Shear-wave Elastography Compared to Respiratory Function Testing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the relationship between transdiaphragmatic pressure (Pdi) and diaphragm shear-wave elastography (SWE) during state-of-the-art respiratory muscle testing including volitional efforts (e.g., maximal inspiratory pressure, maximal expiratory pressure, Valsalva maneuver), as well as maximal phrenic nerve stimulation.

Official Title
-----------------
Comparison of Shear-wave Elastography to State-of-the-art Respiratory Function Testing to Measure the Range of Forces Generated by the Diaphragm Muscle

Conditions
-----------------
Respiratory Function Loss, Respiratory Complication

Intervention / Treatment
-----------------
* Diagnostic Test: Shear-wave elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Adult male and female healthy volunteers. Exclusion Criteria: Volunteers who are pregnant. Volunteers with known pulmonary pathology (COPD, asthma requiring routine treatment).

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Respiratory Function Testing<br>All subjects will receive standard respiratory function testing and ultrasound-based elastography measurements across various behaviors and conditions | Diagnostic Test: Shear-wave elastography<br>* Ultrasound based imaging of diaphragm muscle activity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shear wave speed | Elastography of the diaphragm muscle across various behaviors and conditions | 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elastography, Ultrasound
California WISEWOMAN Project

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to provide low-income, under- or un-insured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.

Official Title
-----------------
California WISEWOMAN Project

Conditions
-----------------
Cardiovascular Diseases, Chronic Diseases

Intervention / Treatment
-----------------
* Behavioral: Women's health


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: National Breast and Cervical Cancer Early Detection Program (NBCCEDP)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 64 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Women's health|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
-----------------
CVD risk