linjc16/ctgov huggingface dataset:
Utilization of Human Papillomavirus (HPV) Vaccine Among Young Men Who Have Sex With Men (MSM) and Parents of Boys (Aged 9 to 18 Years)

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are: to determine the degree of understanding and perceived risks for human papillomavirus (HPV) disease, to examine and assess attitudes for personal use of HPV vaccine and identify potential barriers to HPV vaccine access and utilization in a population of young men who have sex with men (MSM) (under 26 years of age)and in parents of boys aged 9 to 18 years to determine HPV vaccine acceptance and predictors of acceptance in a population of young MSM and in patients of boys ages 9 to 18 years to develop strategies to overcome potential barriers to vaccination and improve vaccine access and utilization via development of targeted educational initiatives.

Official Title
-----------------
Survey Study of the Awareness, Acceptance, and Barriers to Utilization of Human Papillomavirus (HPV) Vaccine Among Young Men Who Have Sex With Men (MSM) and Parents of Boys (Aged 9 to 18 Years)

Conditions
-----------------
Human Papillomavirus (HPV)

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MSM group - under age 26 years Parent group - parent of boy(s) ages 9 to 18 years Exclusion Criteria: MSM group - previous receipt of HPV vaccine Parent group - previous receipt of HPV vaccine by male child

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 26 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MSM<br>Young men (under 26 years of age) who have sex with men | Other: Survey<br>* Self administered anonymous survey<br>|
| Parents<br>Parents of Boys aged 9 to 18 years | Other: Survey<br>* Self administered anonymous survey<br>|

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
-----------------
HPV, Vaccine, Vaccine utilization, Disease awareness
Obstructive Airways Diseases in Pulmonary Clinic (OADPC) Study

Study Overview
=================
Brief Summary
-----------------
This is an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both Chronic Obstructive Pulmonary Disease (COPD) and Asthma patients.

Detailed Description
-----------------
This is an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both COPD and Asthma patients. The study will include adult asthma and COPD patients (age >18). Patients will be enrolled on a continuous basis and will be monitored by capnograph and oximeter before and after lung function assessment and also during and after medical treatment.

Official Title
-----------------
Obstructive Airways Diseases in Pulmonary Clinic (OADPC) Study

Conditions
-----------------
Asthma, Chronic Obstructive Pulmonary Disease (COPD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 Ability and willingness to participate the study and sign informed consent form Asthma / COPD patients Exclusion Criteria: Pregnant women Asthma or COPD patients with FEV1 > 80% Disability or unwillingness to undergo capnography measurement Cannot be assessed for FEV1 Oxygen supply >5 L/min 6. Subjects that gone through LOBECTOMY OF LUNG in the last 5 years.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asthma and COPD patients<br>Patients with COPD and Asthma. Continuous capnography and spirometry measurements of the subjects will be taken from the subjects with at least two minutes recording before the first spirometry assessment. All clinical diagnoses and treatments will be performed according to the department's protocols. This is an observational study with no interventions | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between capnography parameters and severity of asthma | Correlation between the airway obstruction severity calculation based on the capnography parameters and the clinical severity of asthma and COPD as defined by forced expiratory volume in 1 second (FEV1), in severe asthma and COPD patients | 1/2 hour to 48 hours from enrollment of subjects | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Chronic Obstructive Pulmonary Disease (COPD), Capnography
Reduction Mammaplasty and Improved Quality of Life

Study Overview
=================
Brief Summary
-----------------
The data gathered here will be used to evaluate the efficacy and safety of the mammary reduction in patients with macromastia.

Detailed Description
-----------------
The data was gathered using retrospective and follow-up prospective study of a group of patients, consisting of adult women that underwent a breast reduction surgery at the Clinic of Plastic, Reconstructive and Aesthetic Surgery Faculty of Comenius University and at the University Hospital in Bratislava, Ružinov, during the time period between 2000 until May 2014. The data concerning the quality of life of these patients was gathered by using the globally standardized questionnaire Breast Q questionnaire© with the separate software system evaluation tool QScore©. The statistical analysis was conducted using GraphpadPrism program v. 6.01. The total number of respondents consisted of 52 people who were followed-up for up to 12 years.

Official Title
-----------------
Reduction Mammaplasty Safely Increases the Quality of Life in Patients With Mammary Hypetrophy.

Conditions
-----------------
Macromastia, Signs and Symptoms, Quality of Life

Intervention / Treatment
-----------------
* Procedure: Reduction mammaplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above 18 years macromastia on clinical examination fulfilled Breast Q Questionnaire prior to surgery and after surgery signed informed consent Exclusion Criteria: failed to sign informed consent failed to fill the Breast Q Questionnaire patients with altered mental status and behaviour patients with concomitant breast disease, or with previous breast interventions as are radiotherapy, surgery, or breast cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 63 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 |
| --- | --- |
| Patients with macromasty<br>Female adult patients with symptomatic macromasty selected for elective reduction surgery | Procedure: Reduction mammaplasty<br>* Surgical removal of excess breast tissue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Questionnaires about quality of life before and up to 12 years after surgery | 2000-2014 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse outcomes | Evaluation of rate and types of negative outcomes up to 12 years after elective reduction surgery | 2000-2014 |
Study of RO6807952 in Patients With Diabetes Mellitus Type 2

Study Overview
=================
Brief Summary
-----------------
This randomized, double-blind, placebo-controlled, multi-center study will evaluate the efficacy and safety of RO6807952 in patients with diabetes mellitus type 2 inadequately controlled with metformin alone. Patients will be randomized to receive doses of RO6807952, placebo, or liraglutide. The anticipated time on study treatment is 12 weeks.

Official Title
-----------------
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of RO6807952 in Type 2 Diabetic Patients Inadequately Controlled With Metformin Alone

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

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: RO6807952
* Drug: RO6807952
* Drug: liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients >/= 18 and </=70 years of age Diagnosis of diabetes mellitus, type 2 for at least 3 months Treated with a stable dose of metformin Hemoglobin A1c >/=7.0% and </=10.5% at screening Fasting plasma glucose </=240 mg/dL at screening Body mass index >/=27 kg/m2 and </=42 kg/m2 at screening Willing and able to maintain existing diet and exercise habits throughout the study C-peptide >1.5 ng/mL at screening Exclusion Criteria: History of significant liver or kidney disease History of uncontrolled hypertension History of significant cardiovascular disease History of significant diabetic complications History of significant gastrointestinal conditions History of weight loss surgery or procedures involving the gastrointestinal tract History of chronic or acute pancreatitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: Liraglutide Arm<br> | Drug: liraglutide<br>* liraglutide for 12 weeks<br>|
| Placebo Comparator: Placebo Arm<br> | Drug: Placebo<br>* Placebo for 12 weeks<br>|
| Experimental: RO6807952 Arm 1<br> | Drug: RO6807952<br>* multiple doses for 12 weeks<br>|
| Experimental: RO6807952 Arm 2<br> | Drug: RO6807952<br>* multiple doses for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin A1c (HA1c) |  | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting plasma glucose |  | Baseline and 12 weeks | 
| Safety (incidence of adverse events) |  | 12 weeks |
Study of an Environmental Risk Factor in Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Inflammatory bowel disease (IBD) are lifelong chronic diseases affecting the gastrointestinal tract. The precise etiology and the different actors participating to the pathophysiological process leading to the disease development are still not well understood. A complex interaction between genetics, gut microbiota and environmental factors is thought to trigger the inappropriate mucosal immune response observed in IBD patients. We hypothesize that DON might be an environmental risk factor for IBD.The focus on the human relevance of the gut effects of DON by studying its exposure, metabolism and adverse effects in health and disease focusing on IBD patients

Official Title
-----------------
dEoxyniValenol as Risk Factor for Inflammatory Bowel Diseases: Human detoxifiCaTion and Impact On intestiNal Microbiota and Homeostasis

Conditions
-----------------
Inflammatory Bowel Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group 1: patients with ileocolic Crohn's disease requiring surgery Group 2: Patients requiring ileal and / or colonic surgery for a reason other than Crohn's disease or ulcerative colitis (for example, cancer, polyp or diverticulum). Exclusion Criteria: Vegetarian or vegan patients, celiac disease, gluten sensitivity, eating disorders, people with a particular diet or eating behavior or suffering from obesity or anorexia Surgical history: patient having undergone intestinal resection Current treatments: patient receiving antibiotic or probiotic treatment within 6 weeks prior to inclusion / patient having taken topical treatment (suppositories or enema of 5ASA or corticosteroids) within 6 weeks prior to inclusion

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 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 |
| --- | --- |
| Crohn's disease patients<br> | |
| Non IBD patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of Deoxynivalenol and its conjugated metabolites by Liquid Chromatography coupled to tandem Mass Spectrometry (LC-MS/MS). |  | through study completion, an average of 2 years |
Open Facet Joint Denervation in the Treatment of Low Back Pain

Study Overview
=================
Brief Summary
-----------------
A single blinded RCT for adult patients with spine pain. One group had a lumbar laminectomy with denervation of the facet joint at the level decompressed. The other group had a lumbar laminectomy without facet joint denervation. Both groups had their back pain and functional limitations measured using a 10 cm visual analogue scale and the Oswestry disability index (ODI). All measures were taken before surgery and at patients' 6, 12 and 24 week follow-up clinic visit.

Official Title
-----------------
Open Facet Joint Denervation in the Treatment of Low Back Pain -A Randomized Control Trial.

Conditions
-----------------
Back Pain

Intervention / Treatment
-----------------
* Procedure: facet joint denervation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 19 or older a diagnosis of spinal stenosis having neurogenic claudication complained of back pain for at least 3 months Exclusion Criteria: previous surgery on their spine, fracture, systemic inflammatory disease, malignancies or an infection affecting their spine

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| No Intervention: lumbar laminectomy<br> | |
| Active Comparator: lumbar laminectomy with denervation of the facet joint<br> | Procedure: facet joint denervation<br>* Bipolar electrocautery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual analog scale for pain (VAS) | 10 centimeter scale with a minimum of 0 indicating no pain and a maximum of 10 indicating worst pain. | change from baseline score at 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Modified Oswestry Disability score (ODI) | The ODI is divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale. The range of scores is 0 to a maximum of 60. The total score is multiplied by 2 and expressed as a percentage. A score of 0 to 20 points indicates minimal disability; 20 to 40 points, moderate disability; and 40 to 60 points, severe disability. | change from baseline score at 24 weeks |
Study to Evaluate Efficacy and Tolerability of Micardis®/Micardis® Plus in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
Study to evaluate efficacy and tolerability of Micardis®/Micardis® Plus under usual daily-practice prescribing conditions in hypertensive patients

Official Title
-----------------
Post-Marketing Surveillance Study Micardis® Plus

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Micardis®
* Drug: Micardis® Plus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females for whom a medical antihypertensive therapy is indicated Age >= 18 years Exclusion Criteria: Age < 18 years

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with hypertension<br> | Drug: Micardis®<br> <br> Drug: Micardis® Plus<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in morning blood pressure (office and self-measured) |  | up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate |  | up to 6 weeks | 
| Number of patients with adverse drug reactions |  | up to 6 weeks | 
| Assessment of efficacy by investigator on a 5-point scale |  | at week 6 | 
| Assessment of tolerability by investigator on 5-point scale |  | at week 6 | 
| Change in rate of morning complaints |  | up to 6 weeks |
Tracheotomy With and Without Dual Antiplatelet Therapy

Study Overview
=================
Brief Summary
-----------------
Platelet-inhibiting drugs are often used after vascular interventions. Patients who require such therapies are often critically ill, are treated in intensive care units and often require long-term ventilation. For long-term ventilation a tracheotomy is necessary, which is usually performed as a percutaneous dilatative tracheotomy (PDT). As part of this intervention, there is (theoretically) an increased risk of bleeding/an increased rate of complications in patients with a antiplatelet therapy. In addition, there are various techniques for performing a PDT. The current study aims to investigate the frequency of bleeding/complications taking into account the technique used in PDT.

Official Title
-----------------
Evaluation of the Safety of Percutaneous Tracheotomies in Intensive Care Patients With and Without Antiplatelet Therapy and Comparison of Two Tracheotomy Techniques

Conditions
-----------------
Tracheostomy Hemorrhage

Intervention / Treatment
-----------------
* Device: Tracheotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent Percutaneous Dilational Tracheostomy 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 |
| --- | --- |
| Tracheotomy without antiplatelet therapy+technique 1<br> | Device: Tracheotomy<br>* Tracheotomy in patients +/- antiplatelet therapy<br>|
| Tracheotomy under antiplatelet therapy+technique 1<br> | Device: Tracheotomy<br>* Tracheotomy in patients +/- antiplatelet therapy<br>|
| Tracheotomy without antiplatelet therapy+technique 2<br> | Device: Tracheotomy<br>* Tracheotomy in patients +/- antiplatelet therapy<br>|
| Tracheotomy under antiplatelet therapy+technique 2<br> | Device: Tracheotomy<br>* Tracheotomy in patients +/- antiplatelet therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of bleeding during Percutaneous Dilational Tracheostomy (PDT) with and without antiplatelet therapy (AP). | bleeding (yes/no) intervention (yes/no) decrease (>= 1 g/dl) of hemoglobin (yes/no) number of blood transfusion(s) | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Does the technique of PDT affect the bleeding rate? - How often are recognizable cartilage pin fractures in the context of a PDT? - Influence of AP and PDT technology on the frequency of need for a blood transfusion? | cartilage pin fractures seen in endoscopy | 14 days |
Post-operative CRP Trend After Ileocolic Resection in Crohn's Disease Patients.

Study Overview
=================
Brief Summary
-----------------
Our aim is to analyze C-Reactive Protein trends during the post-operative course in Crohn's Disease patients having undergone ileocolic resection and primary anastomosis, for the purpose of anastomotic leak early diagnosis.

Official Title
-----------------
Post-operative CRP Trend May Lead to Early Diagnosis of Anastomotic Leak After Ileocolic Resection in Crohn's Disease Patients.

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Diagnostic Test: C-Reactive Protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Crohn's disease patients Primary ileocolic anastomosis C-Reactive Protein data available in medical file Exclusion Criteria: Protective stoma Associated resection with or without anastomosis during intervention

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anastomotic Leak<br> | Diagnostic Test: C-Reactive Protein<br>* C-Reactive Protein trend in post-operative course<br>|
| Non-Anatomotic Leak<br> | Diagnostic Test: C-Reactive Protein<br>* C-Reactive Protein trend in post-operative course<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic leak | Presence of a collection in the area of the anastomosis on computed tomography scan or evident anastomotic dehiscence at reoperation for peritonitis. | up to 30 days following surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn Disease, Anastomotic Leak, C-Reactive Protein