linjc16/ctgov huggingface dataset:
CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair

Study Overview
=================
Brief Summary
-----------------
The study aims to show variation in CA-125 and other inflammatory markers assumed to be a response to trauma and peritoneal inflammation in the perioperative period of laparoscopic ventral hernia repair

Detailed Description
-----------------
CA-125 and other inflammatory markers as body temperature, CRP, PCT, leucocytes and neutrophils measured pre- and post-operatively - correlated to trauma size i.e. area of dissection, mesh size, number of fixation points etc.

Official Title
-----------------
Multi-centre Observational Pilot-study for Evaluation of Variation in CA-125 and Other Inflammatory Markers in the Perioperative Period of Laparoscopic Ventral Hernia Repair

Conditions
-----------------
Hernia

Intervention / Treatment
-----------------
* Procedure: Laparoscopic ventral hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults admitted for ventral or incisional hernia repair Exclusion Criteria: Loss-of-domain ASA above III Liver failure Abnormal CA-125 prior to 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non-immunosupressed<br>Normal population | Procedure: Laparoscopic ventral hernia repair<br>* Patients operated with laparoscopic repair of ventral or incisional hernia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of variation in inflammatory markers related to trauma impact |  | 6 weeks post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammation, laparoscopy, hernia, incisional, trauma
Oral Contraceptive Pills Compared to Vaginal Rings

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether teens and young women would prefer the Nuvaring to oral contraceptive pills after having tried both methods.

Detailed Description
-----------------
Sexually active young women (n=130), aged 15-21 years, were randomly assigned to use either the vaginal ring or oral contraceptive pills for an initial study interval of three 28-day cycles, followed by three cycles of the alternate method. Participants completed surveys about method use, acceptability and side effects at baseline, after three cycles, and after six cycles, as well as in a follow up telephone interview one month after study completion.

Official Title
-----------------
YOUNG WOMEN'S EXPERIENCES: ORAL CONTRACEPTIVE PILLS VS The VAGINAL RING

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Drug: OCPs
* Device: vaginal ring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sexually active young women (n=130), English or Spanish speaking, aged 15-21 years, able and willing to try oral contraceptives and vaginal rings for 6 months Exclusion Criteria: Not able or willing to use hormonal contraceptives, moving out of the area, pregnant or intending to become pregnant during the study time frame, not sexually active

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 21 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

| Intervention/Treatment |
| --- |
|Drug: OCPs|nan|
|Device: vaginal ring|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance |  |  | 
| Acceptability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaginal ring, Oral contraceptive pills, Teenagers, Young women, Patient satisfaction
A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and effects of VX-702 in subjects with moderate to severe rheumatoid arthritis and who are taking the drug methotrexate.

Official Title
-----------------
A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 When Administered Concomitantly With Methotrexate

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: VX-702


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients 18 to 75 years of age with active RA Must have been taking MTX for at least 6 months No concurrent DMARD treatment (other than a stable dose of MTX) Exclusion Criteria: Planned major surgery (e.g., joint replacement) within the duration of the treatment period of the study Treated with intra-articular injections of corticosteroids within 28 days prior to Day 1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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

| Intervention/Treatment |
| --- |
|Drug: VX-702|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of VX-702 administered with concomitant methotrexate (MTX), and MTX alone |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of VX-702 administered with concomitant MTX, and MTX alone |  |  |
Newborns in Level III Services in Alsace From Mothers With COVID-19

Study Overview
=================
Brief Summary
-----------------
Very little is known about the impact on the newborn of late pre-partum maternal SARS-CoV-2 infection. Care without separation of the mother and her newborn with continued breastfeeding has been advocated in France and by the WHO but is being debated in some countries. Assessment of the development of newborns in their first month of life with this strategy associated with close and secure follow-up. Importance of reporting the potential benefits / risks of this treatment to guide the care of newborns in a persistent epidemic context in a particularly affected region.

Official Title
-----------------
Retrospective Clinical Study of the Care and Follow-up in the First Month of Life of Newborns in Level III Services in Alsace From Mothers With COVID-19

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Newborns born between March 1 and June 30, 2020 to COVID 19 From positive mothers in Strasbourg University Hospital or Mulhouse Hospital. Parents' non-opposition to the analysis of hospitalization data for children contained in the medical file Exclusion criteria: - Parents' opposition to the analysis of hospitalization data for children contained in the medical file

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Year

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 |
| --- | --- | --- |
| Retrospective description of the care and follow-up in the first month of life of newborns in level III services in Alsace from mothers with COVID-19 |  | Files analysed retrospectively from March 01, 2020 to Jun 30, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, SARS-COV-2, Newborns of COVID-19 mothers, COVID-19 Pandemic, COVID-19 Virus Disease
Structural and Functional Characterization of Rare Ocular Diseases

Study Overview
=================
Brief Summary
-----------------
Rare ocular diseases (ROD) are a heterogeneous group of ocular diseases that affect very few people and, generally, for which no tretament is available. An important subgroup of these diseases are inherited retinal degenerations. In this study we focus on understanding the natural history of different ROD that affect the posterior segment.

Official Title
-----------------
Structural and Functional Characterization of Rare Ocular Diseases

Conditions
-----------------
Retinitis Pigmentosa, Stargardt Disease 1, Best Disease, Pattern Dystrophy of Macula, Choroideremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years or older with a diagnosis of a ROD affecting the posterior segment Patients able to undergo all required ophthalmic exams Patients able and willing to sign an informed consent Exclusion Criteria: Patients with other concomitant posterior segment disorders Patients taking drugs known to affect the retina and/or optic nerve Patients that underwent an intraocular surgery (aside from phacoemulsification with intraocular lens implantation), corneal or glaucoma surgery Patients who have participated in the past 12 months or that are currently participating in clinical trials for an ocular disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Change in best corrected visual acuity | Change from baseline in BCVA | Year 2 as compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean macular sensitivity | Change from baseline in mean macular sensitivity on microperimetry | Year 2 as compared to baseline | 
| Change in retinal thickness | Change from baseline in central subfield retinal thickness on OCT | Year 2 as compared to baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinitis pigmentosa, Stargardt's disease 1, Best disease, Pattern Dystrophy of Macula, Choroideremia
Health Related Quality of Life in Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
Previous studies reported health related quality of life impairment in functional dyspepsia patients. Anxiety, depression, disease severity, age, and employment status associated with HRQOL in functional dyspepsia patients. However, data about HRQOL in Asian population was limited.This study aimed to evaluate factors associated with health related quality of life in patients with functional dyspepsia.

Detailed Description
-----------------
126 functional dyspepsia patients will answer SF-36 HRQOL questionnaire, Hospital Anxiety, and Depression Scale, and Short Form Nepean Dyspepsia Index. Functional dyspepsia and Irritable Bowel Syndrome Rome III diagnostic questionnaire and GERD-Q questionnaire will be used to determine FD type and IBS or GERD overlap.

Official Title
-----------------
Factors Associated With Health Related Quality of Life in Patients With Functional Dyspepsia

Conditions
-----------------
Dyspepsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dyspepsia patients Normal or non ulcer esophagogastroduodenescopy finding Exclusion Criteria: History of GI bleeding History of GI malignancies Hepatobiliary tract disease Diabetes mellitus Chronic kidney disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Health related quality of life | Short Form -36 health survey includes one scale for each of eight measured health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These eight domains aggregates into physical component summary and mental component summary. All health domain scales are scored using norm-based scores ranging 0 to 100 with higher scores indicate better health | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | The Hospital anxiety and depression scale (Anxiety score) This consists of seven questions on anxiety on 4 point (0-3) response category. Total score range 0-21. | 2 weeks | 
| Depression | The Hospital anxiety and depression scale (Depression score). This consists of seven questions on depression on 4 point (0-3) response category. Total score range 0-21. | 2 weeks | 
| Dyspepsia symptoms severity | Nepean dyspepsia index (NDI) score. 10-item questionnaire measuring symptoms and health-related quality of life in functional dyspepsia. Each item is measured on a 5 point Likert Scale ranging from 0 (not at all) to 4 (extremely). | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dyspepsia, health related quality of life
COVID-19 and SARS-CoV-2 Detection in Saliva

Study Overview
=================
Brief Summary
-----------------
This study aims to validate the use of human saliva as a substrate for an assay to detect SARS-CoV-2 and define accuracy, analytical sensitivity and specificity of the TaqPath RT-PCR test.

Detailed Description
-----------------
Investigators will carry out validation of a laboratory assay to detect SARS-CoV-2 nucleic acids in human saliva samples. Data for the validation will include the test results from standard nasopharyngeal (NP) swabs (controls) AND matched saliva samples (experimental group) of individuals who are either known to be infected or at high risk of being infected. Investigators hypothesize that the performance of an assay designed specifically for saliva will not perform differently, as defined by a predetermined margin, from the standard assay performed on NP and other respiratory samples

Official Title
-----------------
SARS -CoV-2 Detection in Saliva Samples: A Test Validation Protocol

Conditions
-----------------
RNA Virus Infections

Intervention / Treatment
-----------------
* Diagnostic Test: RT-PCR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Reads and understands English or Spanish Willing and able to provide consent Diagnosed with COVID-19 or at high risk of disease based on objective criteria Exclusion Criteria: Unwilling or unable to provide consent. Pregnant female

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 |
| --- | --- |
| Positive for SARS-CoV-2<br>Individuals who are symptomatic for COVID 19 disease, at high risk of infection or part of a screening program will provide samples for analysis which may reveal a positive result. | Diagnostic Test: RT-PCR<br>* The RT-PCR assay will be performed on paired nasopharyngeal and saliva samples<br>|
| Negative for SARS-CoV-2<br>Individuals who are symptomatic for COVID 19 disease, at high risk of infection or part of a screening program will provide samples for analysis which may reveal a negative result. | Diagnostic Test: RT-PCR<br>* The RT-PCR assay will be performed on paired nasopharyngeal and saliva samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of COVID-19 SARs-CoV-2 in saliva samples versus nasopharyngeal samples | TaqPath RT-PCR assay performed on saliva compared to TaqPath RT-PCR performed on nasopharyngeal samples for assay accuracy, concordance, reproducibility/precision, analytical sensitivity and analytical specificity. | up to 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Detection
Epidemiology and Clinical Presentation of H1N1 Infection in Children in Geneva

Study Overview
=================
Brief Summary
-----------------
This study aims to identify clinical symptoms and outcomes, as well as response to anti-viral treatment in children living in Geneva, with influenza A/ H1N1 infection during the current pandemic.

Official Title
-----------------
Evaluation of a New Virus(Influenza A H1N1/09) in Children: Epidemiology, Clinical Presentation and Outcome, and Response to Treatment

Conditions
-----------------
Healthy, Immunosuppressed, Asthmatic, Neuromuscular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspicion of H1N1 infection Exclusion Criteria: Not available for a 30 days follow-up

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- | --- | --- |
| ABCB1 polymorphisms | ABCB1 gene polymorphisms and neuropsychiatric adverse events in oseltamivir-treated children during influenza H1N1/09 pandemia | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza A H1N1, Children, Epidemiology, Treatment, Oseltamivir, Genetics
DynaCT in Preoperative Imaging Before Insertion of Stentgraft

Study Overview
=================
Brief Summary
-----------------
Endovascular therapy of Aortic Aneurysms depends on good imaging facilities. A relatively new kind of x-ray equipment makes it possible to create computer tomography (CT) - like slice images in the operating room. The purpose of this study is to verify the clinical usefulness of DynaCT in a preoperative setting. To do so we compare aortic measurements in DynaCT to the same measurements in ordinary CT-images which are regarded the gold standard.

Official Title
-----------------
Usefulness of DynaCT Compared to Multidetector CT as Preoperative Imaging Before Insertion of Aortic Stentgraft.

Conditions
-----------------
Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Radiation: DynaCT
* Drug: Iodixanol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not inserted stent graft before. Patiens over 60 Years old. Able to give informed consent. Exclusion Criteria: Not -

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MDCT and additional DynaCT<br> | Radiation: DynaCT<br>* One extra set of images with DynaCT including one extra injection of contrast medium.<br>Drug: Iodixanol<br>* One extra set of images with DynaCT including one extra injection of 50 ml contrast medium.<br>* Other names: Visipaque Amersham Health 270 mg I/ml;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verify clinical usefulness of DynaCT images in preoperative imaging. |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EVAR DynaCT
Mood Patient Powered Research Network (MoodNetwork)

Study Overview
=================
Brief Summary
-----------------
The MoodNetwork, a patient-powered research network (PPRN), is one of 18 PPRNs participating in Patient-Centered Outcomes Research Institute's (PCORI) PCORnet network. Its objective is to improve the nation's capacity to conduct comparative effectiveness research that reflects questions of greatest importance to patients and other stakeholders. A robust data infrastructure will be built that, in phase one, allows participants to contribute data, including those from participant questionnaires, visualize their own health information in intuitive and helpful ways, and share their aggregated de-identified health information within and outside of the Network.

Official Title
-----------------
Mood Patient Powered Research Network (MoodNetwork)

Conditions
-----------------
Mood Disorders, Bipolar Disorder, Major Depressive Disorder, Depression

Intervention / Treatment
-----------------
* Other: Patient Reported Outcomes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking Valid email address Self-identify as having a mood disorder Exclusion Criteria: Under 18 years of age

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 |
| --- |
|Other: Patient Reported Outcomes|Patient reported outcomes will be collected using a variety of questionnaires that assess mood symptoms.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes Working Group Items Questionnaire |  | average of 3 years | 
| Composite International Diagnostic Interview Mania Questionnaire |  | average of 3 years | 
| Mini International Neuropsychiatric Interview Depression |  | average of 3 years | 
| Quick Inventory of Depressive Symptoms Self Report |  | average of 3 years | 
| Altman Self Rated Mania Scale |  | average of 3 years | 
| WHO-five well-being index (WHO-5) |  | average of 3 years | 
| Depression and Bipolar Support Alliance Wellness Tracker Questionnaire |  | average of 3 years | 
| Experience of Care and Health Outcomes Questionnaire |  | average of 3 years |