linjc16/ctgov huggingface dataset:
Brazil Xience V Everolimus-Eluting Coronary Stent System Real-World Outcomes Registry

Study Overview
=================
Brief Summary
-----------------
To evaluate the performance and long-term clinical outcomes of the Xience V everolimus-eluting coronary stent system (EECSS) in the treatment of minimally selective, high risk patients in the real-world clinical practice.

Detailed Description
-----------------
Prospective, multicenter, non-randomized, post-marketing web-based registry.Patients all comers assigned for percutaneous coronary intervention (PCI) who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with implantation of Xience V EECSS only can be included on this Registry.

Official Title
-----------------
Brazil Xience V Everolimus-Eluting Coronary Stent System Real-World Outcomes Registry

Conditions
-----------------
Arterial Coronary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >18 years of age; clinical indication for elective or emergency PCI with stent implantation of at least one angiographically documented coronary artery lesion; agreement to undergo ALL study protocol follow-ups Diseased coronary vessel(s) with the presence of at least one obstruction >50% diameter stenosis by visual estimation in a major epicardial vessel or a major branch (≥2.50mm), with anatomy suitable for percutaneous treatment with implantation of the Xience V EECSS Exclusion Criteria: Known illness with life expectancy <24 months; impossibility to comply with all protocol follow-ups Coronary anatomy unsuitable for percutaneous treatment with implantation of the Xience V EECSS

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 |
| --- | --- | --- |
| Major Adverse Cardiac Events (MACE) at 12 months clinical follow-up |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of procedural success |  | 24 months | 
| MACE at in-hospital |  | 30 days, 6 months, and 24 months | 
| Toll-like receptor (TLR) |  | at 6 and 12 months | 
| Stent thrombosis up to 24 mo |  | up to 24 months | 
| Dual anti-platelet therapy compliance |  | at 1, 6 and 12 months | 
| Major bleeding events |  | at 1, 6 and 12 mo | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Xience V, stent, coronary disease
Video Messages and Vaccination Intention

Study Overview
=================
Brief Summary
-----------------
This study uses an online panel survey to test the impact of video messages on stated likelihood of COVID-19 vaccination. Participants, who have self-identified as unvaccinated against COVID-19, are randomly assigned to either no video message or 1 of 3 video messages to encourage vaccine take-up. The key endpoint is a question about the likelihood of getting vaccinated in the next 30 days.

Detailed Description
-----------------
This study uses an online panel survey to test the impact of video messages on stated likelihood of COVID-19 vaccination. Participants are recruited from the Prolific.co platform. Those who have indicated to Prolific that they have not been vaccinated will be randomly assigned to either no video message or 1 of 3 video messages created by the Vaccinate LA/USC collaborative. The key endpoint is a question about the likelihood of getting vaccinated in the next 30 days.

Official Title
-----------------
The Impact of Video Messaging on Vaccination Intention

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

Intervention / Treatment
-----------------
* Behavioral: Video messages


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults in the Prolific.co panel unvaccinated against COVID-19 Exclusion Criteria: indicated to Prolific.co that they have received a COVID-19 vaccination

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No video message | |
| Experimental: Video message 1<br> | Behavioral: Video messages<br>* video messages aimed at increasing vaccination<br>|
| Experimental: Video message 2<br> | Behavioral: Video messages<br>* video messages aimed at increasing vaccination<br>|
| Experimental: Video message 3<br> | Behavioral: Video messages<br>* video messages aimed at increasing vaccination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccination intention | Probability of getting vaccinated in the next 30 days | 30 days |
Renal Denervation Hypertension After Stroke

Study Overview
=================
Brief Summary
-----------------
It is known, that hypertension is the major risk factor of stroke and recurrent stroke. Blood pressure reduction - together with antithrombotics - remain crucial in stroke prevention. This pilot study will examine the effect of renal nerve denervation in patients with treatment resistant hypertension after ischemic stroke or DWI/DTI-verified stroke. With 24 hours blood pressure measurements the effect after renal nerve denervation is examined 1,3,6 and 12 months after the procedure.

Detailed Description
-----------------
Radio frequent ablation is used to renal nerve denervation (RND) and is a new invasive method used in treatment for hypertensive patients, where the sympathetic nerves to the kidneys ablates. RND shows a significant reduction in the systolic and diastolic blood pressure in patients with treatment resistant hypertension. The hypothesis is that RDN is able to reduce the blood pressure in patients with previous stroke and treatment resistant hypertension and thereby reduce the risk of a new stroke. Aim of study: To validate the reduction in blood pressure after RND in patients with stroke and treatment resistant hypertension compared to the results achieved in patients only with essential hypertension To examine if this treatment is possible on patients after stroke (procedure related limitations and security of the patient) To describe the effect of RND in the development of changes in the white matter over time

Official Title
-----------------
Pilot Study in Renal Denervation in Patients With Stroke and Uncontrolled Hypertension

Conditions
-----------------
Stroke, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18+ years old Clinical verified stroke within the last year Treatment resistant hypertension at 150 mm Hg or higher systolic at consultation Modified Ranking between 0-2 Exclusion Criteria: Lack of informed consent Renal artery anatomy, which prevents the procedure Reno vascular disease Pacemaker Haemodynamic vascular occlusion or valve disease Pregnancy or women in the childbearing age Secondary hypertension Mean systolic blood pressure over 180 mm Hg

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 |
| --- | --- | --- |
| 24 hour blood pressure |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal nerve denervation
Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With Premature Rupture of Membranes at Term

Study Overview
=================
Brief Summary
-----------------
Induction of labour with vaginal misoprostol, in women with premature rupture of membranes at term, results in significant shortening of induction to delivery time in comparison to vaginal PGE2 gel induction.

Official Title
-----------------
Comparison of Misorostol & PGE2 Gel for Immediate Induction of Labour for Premature Ropture of Membranes at Term

Conditions
-----------------
Premature Rupture of Membranes at Term

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Drug: PGE2 gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature rupture of membranes at 37 or more weeks Single live fetus in cephalic presentation Exclusion Criteria: Women in labour Women with contraindication of induction of labour Women with previous caesarean section or uterine surgery
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Active Comparator: A<br>In group A, immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses . | Drug: Misoprostol<br>* In one group of women immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .<br>|
| Active Comparator: B<br>In Group B immediate induction of labour will be done by application of vaginal PGE2 gel 0.5 gm at an interval of 6 hours , a maximum of 2 doses. | Drug: PGE2 gel<br>* In other group immediate induction of labour will be done by intravaginal application of PGE2 gel 0.5 mg at an interval of 6 hours , a maximum of 2 doses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission to delivery time |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caesarean Section rate |  | 48 hours | 
| Neonatal morbidity |  | Till discharge | 
| Maternal morbidity |  | Till discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premature rupture of membranes, Induction of labour with Misoprostol, Induction of labour with PGE2 gel
Can Thrombin Generation Measurement Predict the Risk of Venous Thromboembolism in Acute Ill Patients

Study Overview
=================
Brief Summary
-----------------
Can thrombin generation measurement predict the risk of venous thromboembolism in acute ill patients Traditional coagulation tests do not assess the whole coagulation system. Thrombin generation assays measure the ability of plasma sample to generate thrombin following in vitro activation of coagulation. In contrast to the classical clotting assays, thrombin generation reflects and integrates all pro and anticoagulant reactions that regulate the formation and inhibition of thrombin. The aim of our study is to investigate whether thrombin generation would be able to predict a hypercoagulable state in acute ill patients admitted in the internal medical departments and how it correlates with the Padua prediction score, a score that could assists the risk for venous thromboembolism in hospitalized medical patients. In total 300 patients are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. We will measure the thrombin generation over time in plasma assessed by the calibrated automated thrombogram (CAT).

Conditions
-----------------
Venous Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed inform consent Exclusion Criteria: pregnant women

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 |
| --- | --- |
| No treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| venous thromboembolism |  | 1 week |
Effect of a Bolus of 10 µg/kg of Alfentanil on the Pupillary Pain Index

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the Pupillary Pain Index before and after a bolus of alfentanil in children under general anesthesia, before skin incision.

Official Title
-----------------
Effect of a Bolus of 10 µg/kg of Alfentanil on the Pupillary Pain Index

Conditions
-----------------
Pain, Anesthesia

Intervention / Treatment
-----------------
* Drug: Alfentanil
* Drug: sevoflurane or propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgery under general anesthesia Written informed consent Exclusion Criteria: Chronic pain Preoperative analgesic drug Neurologic disease Ophtalmic disease

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 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: alfentanil<br>Children under general anesthesia for elective surgery. Induction with sevoflurane or propofol according to the preference of the patient. Maintenance with sevoflurane. 5 minutes before skin incision, first assessment of the pupillary pain index. Then injection of 10 µg/kg of alfentanil. After 5 minutes second assessment of pupillary pain index. End of study period, beginning of surgery. | Drug: Alfentanil<br>* Bolus of alfentanil 10 µg/kg 5 minutes before skin incision<br>Drug: sevoflurane or propofol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change between Pupillary Pain Index before and after alfentanil bolus | pupillometry | Five minutes before incision and just before incision. Each measure = 20 seconds |
Integrative Medicine for Chronic Pain

Study Overview
=================
Brief Summary
-----------------
In this study, the effects of a 14-day inpatient treatment in an internal medicine ward for integrative medicine on pain, disability, quality of life, satisfaction with life, depression, and anxiety will be investigated. Furthermore the influence of potential process variables will be evaluated. Effects will be measured after completion of the program (2 weeks), and at 6 months follow up after start of the program.

Official Title
-----------------
Integrative Medicine for Chronic Pain - Process-Outcome-Study in the Context of an Internal Medicine Ward for Integrative Medicine

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: Multimodal integrative medicine inpatient treatment program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with any chronic pain condition at least 6 months pain duration written informed consent Exclusion Criteria: participation in any other clinical study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrative Medicine<br> | Other: Multimodal integrative medicine inpatient treatment program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | VAS | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | VAS | 6 months | 
| Pain Disability | - German Pain Questionnaire | 14 days, 6 months | 
| Health-related quality of life | Short Form (36) Health Survey | 14 days, 6 months | 
| Life satisfaction | Brief Multidimensional Life Satisfaction Scale | 14 days, 6 months | 
| Depression | Beck Depression Inventory | 14 days, 6 months | 
| Acceptance | Emotional/Rational Disease Acceptance Questionnaire | 14 days, 6 months | 
| Mindfulness | Conscious Presence and Self Control (CPSC) Scale | 14 days, 6 months | 
| Subjective stress | Perceived Stress Scale | 14 days, 6 months | 
| Easiness of life | Questionnaire on emotional and physical reactions | 14 days, 6 months | 
| Ability and will to change | Ability and will to change Questionnaire | 14 days, 6 months | 
| Safety | Adverse events | 14 days, 6 months | 
| Pain Disability | - Pain Disability Index | 14 days, 6 months |
Pharmacogenomics of Anti-TNF (Anti-tumor Necrosis Factor) Treatment in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The main aim of this study is to identify genetic markers (at DNA and RNA level) which are involved in the response to treatment with monoclonal antibodies against TNF in patients with rheumatoid arthritis.

Detailed Description
-----------------
Rheumatoid Arthritis (RA) is a severe inflammatory disease and genetic factors are known to play an important role in its pathogenesis. Genetic factors are also involved in determining the prognosis of RA. Identifying the genetic factors that predispose to mild or aggressive RA is not easy and up to now only a few of these factors -like certain HLA-DR species- are known. The Rheumatology department of the Radboud University Nijmegen Medical Centre (RUNMC) has collected a unique inception cohort of over 500 patients with RA, that have been followed from an early stage of disease for up to 10 years with detailed measurements of disease activity, joint damage and other characteristics of disease progression. In this project we use this patient group to study polymorphisms in a large battery of genes for their effect on RA disease activity/progression.

Official Title
-----------------
Pharmacogenomics of Anti-TNF Treatment in Patients With Rheumatoid Arthritis

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with RA according to the ACR criteria who are treated with monoclonal anti-TNF antibodies. Exclusion Criteria:

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatoid arthritis, pharmacogenetics, anti-TNF, high throughput genotyping
Observational Study of Diffuse Large B Cell Primary Breast Lymphomas Treated With RCHOP +/- XRT

Study Overview
=================
Brief Summary
-----------------
This is a multi-center observational study to assess addition of Rituximab in the treatment of previously untreated patients with Diffuse Large B-Cell Lymphomas(DLBCL) over an enrollment period of 60 months. Patients in this study are enrolling for the collection of their data on observations made during normal clinical practice.

Official Title
-----------------
A Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas Treated With RCHOP With or Without Radiotherapy

Conditions
-----------------
Lymphoma, Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously untreated patients with DLBCL of the breast. Patients must have CD20 positive tumors. Stage IE or IIE. Must have at least one objective measurable or evaluable disease. Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study. Patients must not have historical or radiographic evidence of CNS metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement. Patients must have an ECOG performance status 0-2. Patients must have adequate organ function as evidenced by the following laboratory studies (within 2 weeks prior to registration): Creatinine Clearance >= 50 ml/min Total bilirubin <= 2.0 mg/dl and AST <= 2 x upper limit of normal. If documented hepatic involvement with lymphoma, total bilirubin can be <= 3 x *ULN, and AST <= 5 x ULN. Absolute neutrophil count >= 1500/mm3 and platelet count >= 100,000/mm3. If documented bone marrow involvement with lymphoma, absolute neutrophil count >= 500/mm^3 and platelet count >= 50,000/mm^3. Patients must be age >= 18 years. Women must not be pregnant or breast feeding due to potential harmful effects to the fetus/baby. Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception. Patients must not have an active infection requiring parental antibiotics. Patients with known HIV infection are excluded. Patients must have a normal left ventricular ejection fraction to be eligible.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rituximab|Calculated per patient|

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

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