linjc16/ctgov huggingface dataset:
Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
This is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible. One-hundred patients will be randomly assigned to either partial upper sternotomy (50 patients) or full sternotomy AVR (50 patients). Inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic valve replacement. Exclusion criteria are inclusion in other trial, left ventricular ejection fraction less than 0.45, previous cardiac surgery, or urgent/emergent surgery. Mechanical and bioprosthetic (stented or sutureless) aortic valves will be implanted. Clinical characteristics will be registered. Clinical postoperative outcomes including bleeding outcomes will be registered. Routine blood sampling will be performed pre- and postoperatively. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.

Conditions
-----------------
Aortic Valve Stenosis, Heart Valve Diseases

Intervention / Treatment
-----------------
* Procedure: Minimally invasive aortic valve replacement
* Procedure: Full sternotomy aortic valve replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography Referred for medically indicated aortic valve replacement Sinus rhythm Provide written informed consent Exclusion Criteria: Inclusion in other trial Left ventricular ejection fraction less than 0.45 Presence of any coexisting severe valvular disorder Previous cardiac surgery Urgent or emergent surgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Partial upper hemisternotomy aortic valve replacement<br>Partial upper hemisternotomy AVR will be performed according to current standard of care practices. | Procedure: Minimally invasive aortic valve replacement<br> <br> |
| Experimental: Full sternotomy aortic valve replacement<br>Full sternotomy AVR through a standard median sternotomy will be performed according to current standard of care practices. | Procedure: Full sternotomy aortic valve replacement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Universal definition of perioperative bleeding in adult cardiac surgery |  | Within 3 days from surgery |
The Effect of PPI Therapy on the Result of Helicobacter Pylori Diagnostic Tests

Study Overview
=================
Brief Summary
-----------------
STUDY PROTOCOL: The study will include 30 patients ages 18-80y that had a gastroscopy for various reasons. The patients should not be on PPI therapy . If during the gastroscopy there are some pathologies that require a second look endoscopy after some weeks of therapy (ulcers or esophagitis), the investigators will repeat the gastroscopy within a month. During the first gastroscopy a biopsy will be taken for histological examination and for a rapid urease test and an urea breath test will be done soon after the procedure. If one of the tests is positive the investigators postulate that the Helicobacter pylori is actually present. After the gastroscopy the patient is given a full dose of PPI (as indicated) and helicobacter tests are repeated in the next endoscopy (under PPI therapy) . Any positive test that become negative in the second endoscopy is considered false negative.

Conditions
-----------------
Helicobacter Pylori

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cohort of helicobacter pylori positive patients undergoing EGD for different indications and not treated with PPI- Exclusion Criteria: Patients younger than 18 years and older than 80 years Severe background diseases Previous eradicated helicobacter pylori infection

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort of consecutive patients undergoing EGD treated with PPI<br>Patients positive for helicobacter pylori undergoing EGD, started on PPI therapy for a month, repeated diagnostic tests for Helicobacter pylori after a month of therapy (urease test, histology and breath test) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of PPI treatment on helicobacter pylori diagnostic tests |  | 1 month of therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
helicobacter pylori, urease test, 13C-UBT, the focus of the study is to evaluate a possible effect of PPI therapy on Helicobacter pylori diagnostic tests
Cost of Care for Juvenile Idiopathic Arthritis

Study Overview
=================
Brief Summary
-----------------
This project seeks to collect data on healthcare utilization and expenditure rates in Juvenile Idiopathic Arthritis (JIA) patients from across the US, correlate these costs with disease activity and outcome measures and determine methods by which to reduce the economic impact while improving outcomes.

Detailed Description
-----------------
SPECIFIC AIMS AND OBJECTIVES The specific aims of this registry protocol are: To create and maintain a secure online database of patients with JIA To collect data elements related to cost of care in patients with JIA Compare standard outcome and disease activity measures to health care expenditures in JIA To determine methods by which to reduce costs while improving outcomes and quality of care The study plans to enroll 300 or more subjects from 3 medical centers in the US over a 24 month period. Subjects in the study are patients with Juvenile Idiopathic Arthritis. Enrollment into the protocol will include key demographic and clinical data including, medication exposures, disease severity, and function including disease-specific data elements; and estimates of health care service utilization and health care expenditures. Data will be collected once per subject within the context of a standard of care visit.

Official Title
-----------------
Cost of Care for Juvenile Idiopathic Arthritis

Conditions
-----------------
Juvenile Idiopathic Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has been diagnosed with JIA by a pediatric rheumatologist according to published criteria. Person providing consent must be able to read English. Subject (and/or parent/legal guardian) is able to provide informed consent and willing to comply with study procedures. Exclusion Criteria: Subject/ legal guardian is unwilling to provide consent, cannot read English, or does not meet published criteria for JIA. Coexisting rheumatologic disorder Diagnosis of fibromyalgia Participation in a drug trial in the past 6 months.
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 |
| --- | --- | --- |
| Direct and indirect costs | Patient's history will be reviewed for the prior 6 months to enrollment for expenses incurred related to JIA and it's treatment. This will be done through chart review and questionnaires completed by the patient/parent. | 6 months prior to enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life questionnaires | Self reported questionnaires will be completed by parent. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
JIA, Juvenile Idiopathic Arthritis, Cost of Care, Quality of Life, QOL
Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the relative bioavailability of Ribavirin 200 capsules and Rebetol 200 mg capsules in females under fasting conditions.

Official Title
-----------------
A Relative Bioavailability Study of Ribavirin (Geneva Pharmaceutical Technology Corporation, N.J., U.S.A.) 200 Capsules and Rebetol (Schering Corporation, N.J., U.S.A.) 200 mg Capsules in Females Under Fasting Conditions.

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.)
* Drug: Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.) | Drug: Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.)<br> <br> |
| Active Comparator: 2<br>Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.) | Drug: Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 30 days |
Olanzapine for the Prevention of Postoperative Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
Nausea and vomiting (PONV) remain a common problem in surgical units. Even after two or three prophylactic antiemetic interventions, patients with all four of the Apfel risk factors for PONV have an estimated 30 to 40% chance of suffering PONV. Olanzapine as an antiemetic represents a new use of an antipsychotic drug.

Detailed Description
-----------------
Aim of the Research, to compare the effects of oral 10 and 5 mg Olanzapine for the Prevention of Postoperative Nausea and Vomiting

Official Title
-----------------
Olanzapine for the Prevention of Postoperative Nausea and Vomiting After Laparoscopic Surgery in High-risk Patients: A Randomized Controlled Trial

Conditions
-----------------
Postoperative Nausea

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: 5 mg Olanzapine Tablets
* Drug: 10 mg Olanzapine Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I and II patients undergoing ambulatory laparoscopic gynecologic surgery with general anesthesia patients have at least two of the four Apfel risk factors for PONV2 Lack of history of psychiatric and psychotic illnesses. Exclusion Criteria: ASA III and ≥ IV patients Psychological diseases History of chemotherapy have a pre-existing vestibular disorder or history of dizziness or preexisting nausea or vomiting in the 24 h before surgery, or were being treated with regular antiemetic therapy including systemic corticosteroids.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All patients will receive oral 10, 5 mg Olanzapine or placebo one hour preoperative
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>patients will receive oral placebo tablets one hour preoperatively | Drug: Placebo<br>* oral Placebo tablets one-hour preoperatively<br>|
| Active Comparator: Group 2<br>patients will receive oral 5 mg Olanzapine tablets one hour preoperatively | Drug: 5 mg Olanzapine Tablets<br>* oral 5 mg Olanzapine tablets one-hour preoperatively<br>* Other names: zyprexa;|
| Active Comparator: Group 3<br>patients will receive oral 10 mg Olanzapine tablets one hour preoperatively | Drug: 10 mg Olanzapine Tablets<br>* oral 10 mg Olanzapine tablets one-hour preoperatively<br>* Other names: zyprexa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nausea and/or vomiting score | the occurrence of nausea and/or vomiting by nausea score | first 24 hours postoperative |
A Study of Pharmacodynamics of RO5083945 in Patients With Head and Neck Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
This open-label study will assess the pharmacodynamics, safety and efficacy of RO5083945 as compared to cetuximab in patients with head and neck squamous cell carcinoma. Patients will receive at least 2 infusions of either RO5083945 or cetuximab. Anticipated time on study treatment is up to 3 months, and target sample size is <50.

Official Title
-----------------
An Exploratory, Open Label Multicenter Study to Investigate Pharmacodynamic of RO5083945, a Human Monoclonal Antibody Antagonist of Epidermal Growth Factor Receptor (EGFR), Compared to Cetuximab in Patients With Operable Head and Neck Squamous Cell Carcinoma

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

Intervention / Treatment
-----------------
* Drug: RO5083945
* Drug: cetuximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >/=18 years of age squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx Exclusion Criteria: carcinoma of nasal cavity, paranasal sinus and nasopharynx recurrent squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx known positivity for HIV, hepatitis B and/or hepatitis C infection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: RO5083945<br>* 700mg iv weekly<br>|
| Active Comparator: B<br> | Drug: cetuximab<br>* 400mg/m2 iv 1st dose, 250mg/m2 iv subsequent weekly doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immune cell infiltration head and neck squamous cell cancer (HNSCC) |  | through study completion or early study discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels |  | through study completion or early study discontinuation | 
| safety and efficacy: AEs, laboratory parameters, tumour assessments |  | through study completion or early study discontinuation |
Prognosis of Behavioral Addiction in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Our hypothesis is that the conventional treatment of Behavioral Addiction in Parkinson's disease is often not effective, and that affects the motor aspects (worsening akinéto-rigid syndrome and / or worsening of dyskinesia due to higher levodopa doses to compensate for the drop in behavioral addictions) and non-motor (withdrawal syndrome dopamine agonist) anxiously including apathy. Our goal is to describe the natural history of Behavioral Addiction under the effect of the evolution of the disease and adapt treatment according to the prior art, through a study of a larger population of patients than in the few published studies.

Conditions
-----------------
Addiction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age greater than or equal to 30 years Parkinson's disease according to the criteria of UKPDSBB Time evolution of the top disease or equal to 5 years Exclusion criteria: Lack of Parkinson's disease and atypical parkinsonism Patient not previously included in PD-BADGE

Ages Eligible for Study
-----------------
Minimum Age: 30 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 behavioral addiction<br> | |
| - Patients with no behavioral addiction<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival time before disappearance of behavioral addiction defined by a score of less than 2 on the scale of behavioral assessment of Parkinson's disease |  | 12 months after selection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson disease, behavioral addiction, akinéto-rigid syndrome, dopamine agonist
Prospective Multidisciplinary Post-COVID-19 Registry Tyrol

Study Overview
=================
Brief Summary
-----------------
Longitudinal, prospective observational cohort study enrolling patients with persisting symptoms (> 12 weeks) after COVID-19 in a multidisciplinary care model.

Detailed Description
-----------------
Post-COVID-19 syndrome comprises a set of persistent physical, cognitive and/or psychological symptoms that continue for more than 12 weeks after illness and are not attributable to alternative diagnoses. As these symptoms may manifest in all COVID-19 severity grades, even in patients with mild or moderate disease, there is an urgent need for resource allocation in the health care system and accompanied research proposals to understand disease phenotypes and clinical trajectories. With this prospective multidisciplinary registry, the investigators aim to establish a clinical and researchbased system by providing optimized medical diagnostic and therapeutic approaches in a model region in Austria (Tyrol).

Official Title
-----------------
Prospective Multidisciplinary Post-COVID-19 Registry Tyrol

Conditions
-----------------
Post COVID-19 Condition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with persistent post COVID symptoms ≥ 12 weeks post COVID functional status scale (PCFS) ≥ 2 Exclusion Criteria: observation time after infection < 12 weeks PCFS < 2
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 |
| --- | --- | --- |
| Prevalence rates of post-COVID patients requiring multidisciplinary care. | To quantify disease burden by prevalence rates of post-COVID patients requiring multidisciplinary care. | 2 years | 
| Characterisation of symptom patterns associated with impaired functional status. | Characterisation of symptom patterns associated with impaired post covid-19 functional status scale ≥ 2. | up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
long COVID, post COVID-19 syndrom, long term sequelae
Evaluation of Wear Experience With Daily Contact Lenses

Study Overview
=================
Brief Summary
-----------------
To evaluate the wear experience of current monthly replacement contact lens wearers after they have been fit into a daily disposable contact lens.

Official Title
-----------------
Evaluation of Wear Experience With PRECISION1® Contact Lenses in Biofinity® Contact Lens Wearers

Conditions
-----------------
Contact Lens

Intervention / Treatment
-----------------
* Device: Precision1® Daily Disposable Contact Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently wear Biofinity® monthly replacement spherical contact lenses. Distance visual acuity of 20/25 or better with current contact lenses. Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI). Ability to give informed consent. Willing to spend time for the study, which includes attending two study visits and wearing contact lenses on days between study visits. Exclusion Criteria: No current ocular inflammation or infection. Not currently pregnant or lactating.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All participants are fit with the study daily disposable lenses<br>All subjects are re-fit into their habitual monthly replacement contact lenses. Subjects are requested to wear the lenses for one week, for a minimum of at least 6 hours per day for 5 days. Upon return, subjects are refit into the daily disposable contact lenses. | Device: Precision1® Daily Disposable Contact Lens<br>* Soft, spherical contact lens used to correct distance vision.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Assessment of Precision1® Daily Disposable Contact Lens | Contact Lens Dry Eye Questionnaire (CLDEQ) survey (0-37, with higher scores related to higher symptoms) | 2 weeks |