linjc16/ctgov huggingface dataset:
Evaluation of Surfactant Protein B in the Differential Diagnostics of Dyspnea

Study Overview
=================
Brief Summary
-----------------
Establishing new biochemical markers in the differential diagnostics and risk stratification in heterogeneous patient collectives is becoming more and more important. The markers should be objective, reliable, reproducible, quick and cost effective as well as specific and sensitive. Concerning the differential diagnostics of dyspnea, NT-pro-BNP plays the most important role for the evaluation of a cardiac origin. However, a corresponding biochemical marker for pulmonary stress is lacking. The aim of the study at hand therefore was the evaluation of surfactant protein B in the differential diagnostics of pulmonary and cardiac diseases.

Conditions
-----------------
Dyspnea, Cardiac Disease, Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients presenting with dyspnea and giving informed consent Exclusion Criteria: outpatients lack or doubt of legal competence indication for mechanical ventilation pregnancy palliative patients CPAP/LTOT BMI > 30 kg/m2 sepsis anemia dialysis

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surfactant protein B serum levels |  | Days 1, 3 and 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surfactant protein B, differential diagnostics
Genetic Factors in Chronic Sinusitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn more about the genetics of chronic sinusitis and identify genes involved in chronic sinusitis.

Official Title
-----------------
Genetic Factors in Chronic Sinusitis

Conditions
-----------------
Chronic Sinusitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years Diagnosis of chronic sinusitis or normal sinuses (with verification by imaging.) You must have a recent CT scan showing either normal sinuses or the presence of sinus disease. Exclusion Criteria: Genetic or acquired immunodeficiency Ciliary dyskinesia Cystic fibrosis Autoimmune disease Cancer of the sinuses

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control<br>Adults with normal sinuses | |
| case<br>Adults with chronic sinusitis and positive findings on imaging. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of genetic variation with CRS disease status |  | Adult age |
Obstructive Sleep Apnoea in Adolescents With Thoracic Aortic Aneurysm

Study Overview
=================
Brief Summary
-----------------
The objective of this prospective cohort study is to determine the prevalence of obstructive sleep apnoea (OSA) in patients with and without thoracic aortic aneurysm.

Detailed Description
-----------------
The objective of this prospective cohort study is to determine the prevalence of obstructive sleep apnoea (OSA) in patients with and without thoracic aortic aneurysm.

Official Title
-----------------
Obstructive Sleep Apnoea in Adolescents With Thoracic Aortic Aneurysm

Conditions
-----------------
Thoracic Aortic Aneurysm Without Rupture, Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years. Diagnosis of thoracic aortic aneurysm defined by the following parameters: Women: at the level of the sinus of valsalva ≥39mm, or ascending aorta ≥42mm. (for controls: <39mm and <42mm respectively); Men: at the level of the sinus of valsalva ≥44mm, or ascending aorta ≥46mm. (for controls: <44mm and <46mm respectively) Exclusion Criteria: Patients on continuous positive airway pressure (CPAP) therapy for OSA at baseline. Patients with known central sleep apnoea. Patients on morphine or other opioid medication, heroin addiction, alcohol addiction. Patients with moderate or severe aortic regurgitation. Patients with moderate or severe aortic stenosis. Pregnant patients.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thoracic Aortic Aneurysm<br>Patients with Thoracic Aortic Aneurysm: Women: at the level of the sinus of valsalva ≥39mm, or ascending aorta ≥42mm. Men: at the level of the sinus of valsalva ≥44mm, or ascending aorta ≥46mm. | |
| No Thoracic Aortic Aneurysm<br>Patients without Thoracic Aortic Aneurysm: Women: at the level of the sinus of valsalva <39mm, or ascending aorta <42mm. Men: at the level of the sinus of valsalva <44mm, or ascending aorta <46mm. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Obstructive Sleep Apnea | Prevalence of Obstructive Sleep Apnea according to a Sleep study (The ApneaLink™) | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracic Aortic Aneurysm, Obstructive Sleep Apnea
DNA Methylation Biomarkers for Cervical Cancer Screening

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective study is to evaluate whether DNA methylation can be applied in cervical cancer screening.

Official Title
-----------------
DNA Methylation Biomarkers for Cervical Cancer Screening

Conditions
-----------------
Cervical Cancer, Cervical Intraepithelial Neoplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with age ≥20 and sexual experience Agree to sign ICF Exclusion Criteria: women had received Hysterectomy women had destructive therapy for cervical lesions in 6 months, for examples: conization, Laser or cryotherapy, chemotherapy, and radiation therapy Women are at pregnancy or had baby delivery in 6 weeks

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of DNA methylation in identification of CIN3 or worse. | Patient's information, including clinical diagnosis and the molecular testing results etc., will be collected. Performances of the screening tools will be compared. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNA methylation, Cervical cancer
Protect Chronic Tibial Nerve Stimulator (CTNS) System

Study Overview
=================
Brief Summary
-----------------
30 patient Study. All patients implanted with StimGuard Protect System. Patient followed out to 90 days.

Detailed Description
-----------------
The proposed therapy is called chronic tibial nerve stimulation (CTNS), which is a low-risk, minimally invasive chronic implant for the treatment of urgency urinary incontinence. CTNS works by the same mechanism as percutaneous tibial nerve stimulation (PTNS), but is provided for chronic use with an implantable device. CTNS treatment involves the placement of a minimally invasive stimulator with an embedded receiver at the tibial nerve. The Protect CTNS System has an external transmitter that activates the implanted stimulator and sends mild electrical pulses to the tibial nerve. These impulses travel to the sacral nerve plexus, the group of nerves at the base of the spine responsible for bladder function. Since stimulation with the Protect CTNS System is chronic it is expected that bladder activity can be changed more quickly and without the frequency of treatments related to PTNS.

Official Title
-----------------
A European Trial to Assess the Efficacy of an Implantable Wireless Neuromodulation Device at the Tibial Nerve to Treat Urinary Urgency Incontinence

Conditions
-----------------
Urge Incontinence

Intervention / Treatment
-----------------
* Device: Device: StimGuard Protect System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of overactive bladder with urgency urinary incontinence Exclusion Criteria: Primary complaint of stress urinary incontinence

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: Chronic Tibial Implant Arm<br>StimGuard Protect System (Chronic Tibial Nerve Stimulation) Implant Procedure. Lead implanted adjacent to tibial nerve. Wireless rechargeable system. | Device: Device: StimGuard Protect System<br>* Lead implanted adjacent to tibial nerve. Wireless rechargeable system.<br>* Other names: Chronic Afferent Nerve Stimulation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Urge Incontinence Episodes |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Efficacy, Implantable, Wireless, Neuromodulation, Device, Tibial
Does Patient Activity Level Affect 24-Hour Pad Test Results in Stress-Incontinent Women

Study Overview
=================
Brief Summary
-----------------
We hypothesised that in women with stress urinary incontinence, the severity of leakage on a 24 hour pad test was affected by activity.

Detailed Description
-----------------
We asked women to perform two separate pad tests, one with normal activity, and another with decreased activity.

Official Title
-----------------
Does Patient Activity Level Affect 24-Hour Pad Test Results in Stress-Incontinent Women?

Conditions
-----------------
24-hour Pad Test Weight Gain With and Without Activity

Intervention / Treatment
-----------------
* Behavioral: minimal activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stress urinary incontinence Exclusion Criteria: language other than english

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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: 24-hour pad test<br>decreased activity | Behavioral: minimal activity<br>* Pad test with minimal activity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour pad test weight gain (mls) |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
24-hour pad test, Activity, Stress urinary incontinence
Study of ACE-536 in Healthy Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out whether ACE-536 can be safely given to patients. This study will also look to see if ACE-536 increases red blood cells, the cells that carry oxygen in the body.

Official Title
-----------------
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ACE-536 in Healthy Postmenopausal Women

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Biological: ACE-536
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Postmenopausal women Body Mass Index (BMI) of 20 - 32 kg/m2. Key Exclusion Criteria: History of hypertension Subject has received any erythropoiesis stimulating agents (e.g., Epogen, Procrit, Aranesp, etc.) within 6 months prior to Day 1 History of clinically significant cardiac, endocrine, hematologic, hepatic, immune, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other disease Surgery within 3 months (other than minor cosmetic surgery or minor dental procedures) Subject has received treatment with another investigational drug, or approved therapy for investigational use within 1 month prior to Day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to Day 1, whichever is longer

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACE-536<br>Subjects assigned to 1 of 5 possible dosing groups. | Biological: ACE-536<br>* Subjects receive a total of 2 subcutaneous doses of ACE-536 on Day 1 and Day 15.<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Subjects receive a total of 2 subcutaneous doses of placebo on Day 1 and Day 15.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events as a measure of safety and tolerability. |  | 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACE-536 serum concentration after single and multiple ascending doses. |  | 22 weeks | 
| Hemoglobin levels after single and multiple ascending doses. |  | 22 weeks |
Assessing the Efficacy of Steroid Treatment of Achalasia

Study Overview
=================
Brief Summary
-----------------
Would systemic steroids be an effective treatment in early variants of achalasia?

Official Title
-----------------
A Pilot Study Assessing the Efficacy of Steroids in the Treatment of Achalasia

Conditions
-----------------
Achalasia

Intervention / Treatment
-----------------
* Drug: Apo-Prednisone Cordorol, Detasone - Prednisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adults ages 18-90 with a diagnosis of achalasia confirmed by findings on esophageal manometry and barium esophagogram will be eligible for the study. Eckardt score6 greater or equal to 6 or 2 or greater for dysphagia and/or regurgitation Symptoms less than 2 years Exclusion criteria: Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy and injection; Greater than mild esophageal dilation Type 1 achalasia as defined by the Chicago classification scheme7 and/or esophageal diameter > 3cm; Prior treatment for achalasia Use of medications that might affect LES pressure such as anticholinergics or calcium channel antagonists Symptom duration greater than 2 years Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss Pregnant and lactating females will be excluded as steroids are not thought safe for the fetus.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Other: Prednisone<br>Prednisone (study medication) at a dose of 40mg for 1 week, then 30mg for 1 week, then 20mg for 1 week, then 10mg for 1 week, and then stop the medication. | Drug: Apo-Prednisone Cordorol, Detasone - Prednisone<br>* Oral prednisone (study medication) at a dose of 40mg for 1 week, then 30mg for 1 week, then 20mg for 1 week, then 10mg for 1 week, and then stop the medication.<br>* Other names: Corticosteroid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of patients with an Eckhart score ≥ 6 at 1 month |  | Baseline to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with symptomatic improvement (Eckardt sore 6 or greater) |  | baseline to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trouble swallowing, dysphagia, disorder of the esophagus
The Effect of a Protective Message on Critical Evaluation of Fake News

Study Overview
=================
Brief Summary
-----------------
Background: Disinformation has become an increasing societal concern, especially due to the speed that news is shared in the current digital era. In particular in the healthcare sector disinformation can lead to serious casualties, as the current COVID-19 crisis clearly shows. Objective: The main aim of this study was to experimentally examine the effects of information about the source's and a displayed protective warning message on users' critical evaluation of news items, as well as the perception of accuracy of the news item. Methods: A 3(unreliable versus reliable versus no identified source) x 2 (protective message: with versus without) between subject design has been conducted among 307 participants (mean age = 29 years, SD = 10.9 years).

Official Title
-----------------
The Effect of Source Type and Protective Message on the Critical Evaluation of News Messages on Facebook: An Experimental Study in the Netherlands.

Conditions
-----------------
Disclosure of Protective Message

Intervention / Treatment
-----------------
* Behavioral: Source of news


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Facebook user older than 18 Dutch Exclusion Criteria: younger than 18 years no facebook

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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: unreliable source<br>In this condition participants receive a news message from an unreliable source | Behavioral: Source of news<br>* The main intervention was the source of the news that was shown to participants<br>|
| Experimental: reliable source<br>In this condition participants receive a news message from an reliable source | Behavioral: Source of news<br>* The main intervention was the source of the news that was shown to participants<br>|
| Experimental: no source<br>In this condition participants receive a news message without a source | Behavioral: Source of news<br>* The main intervention was the source of the news that was shown to participants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Critical evaluation of source and news | questionnaire | immediately after exposure, 5 minutes |
Evaluation of Electronic Florbetapir (18F) Interpretation Training in Japanese Physicians

Study Overview
=================
Brief Summary
-----------------
This study is designed to validate the Japanese electronic florbetapir (18F) interpretation training program intended for post-approval implementation in Japan.

Official Title
-----------------
Evaluation of Computer-Based Training to Educate Japanese Physicians in the Methods of Interpreting Florbetapir (18F) PET Scans

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Florbetapir (18F)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese Society of Nuclear Medicine (JSNM) Positron Emission Tomography (PET) Certified Nuclear Medicine Physician Minimal hands-on experience and no formal training in the visual interpretation of florbetapir (18F) brain PET scans Minimal hands-on experience and no formal training in the quantitation of florbetapir (18F) brain PET scans Exclusion Criteria: Prior hands-on experience or formal training in the visual interpretation and/or quantitation of florbetapir (18F) PET scans
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physician Readers<br>Physician readers will interpret 60 Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to florbetapir (18F) as part of this study. | Drug: Florbetapir (18F)<br>* No Florbetapir (18F) will be administered in this study.<br>* Other names: 18F-AV-45;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter Rater Reliability | Measure of agreement among readers using a binary visual read method (amyloid positive/negative) calculated using Fleiss' kappa. All scans were read in a blinded fashion without access to clinical information. | Scan acquired 50-60 minutes post injection | 
| Percent Agreement with Expert Panel | Individual reader scan results will be compared to the expert panel's consensus rating for each scan. | Scan acquired 50-60 minutes post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inter reader reliability after application of quantitation software | Evaluate the percent change in inter reader reliability after implementation of quantitation analysis. | Scan acquired 50-60 minutes post injection | 
| Change in agreement with expert panel | The percent change in individual reader agreement with the expert panel's consensus rating will determined after implementation of quantitation analysis. | Scan acquired 50-60 minutes post-injection |