linjc16/ctgov huggingface dataset:
Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.

Official Title
-----------------
Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Rivaroxaban (Xarelto, BAY59-7939)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS (Central Nervous System) systemic embolism, and who consent to participate in the study

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 |
| --- | --- |
| Group 1<br> | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* Patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Decision regarding dose and duration of treatment made at the discretion of the attending investigator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjudicated major bleeding events |  | after 1 year or until 30 days after end of rivaroxaban therapy | 
| Safety variables will be summarized using descriptive statistics based on adverse events collection |  | after 1 year or until 30 days after end of rivaroxaban therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | after 1 year or until 30 days after end of rivaroxaban therapy | 
| Adjudicated symptomatic thromboembolic events |  | after 1 year or until 30 days after end of rivaroxaban therapy | 
| Persistence with rivaroxaban treatment: Reasons for any switch from or interruption of rivaroxaban treatment |  | after 1 year or until 30 days after end of rivaroxaban therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Embolism, Atrial fibrillation
Efficacy and Safety of Covid-19 Vaccine in Cardiac Patients

Study Overview
=================
Brief Summary
-----------------
Efficacy and safety of covid-19 vaccine in Cardiac patients

Detailed Description
-----------------
investigate the efficacy and safety of covid-19 vaccine in cardiac patients and its possible assocciated morbidity

Official Title
-----------------
Efficacy and Safety of Covid-19 Vaccine in Cardiac Patients

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects diagnosed as STEMI undergo PPCI as (Fourth universal definition of myocardial infarction (2018) Kristian Thygesen) 10 with age range from 18 to 80 years after 1 month of STEMI . Exclusion Criteria: Patients with previous covid infection confirmed by swap or CT chest or ICU addmision. Patients with previous covid infection confirmed by qualitative antibdy test . Patients with history of anaphylaxis to any component of the vaccine should not take it . patients with febrile illness or acute , ongoing infection . immunosuppressive diseases .

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

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 |
| --- | --- | --- |
| all cause mortality | all cause mortality | one year | 
| Myocardial infarction | Myocardial infarction | one year | 
| stent thrombosis | stent thrombosis | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death. Cardiovascular death. Cardiovascular death.Cardiovascular death. cardiovascular death | Cardiovascular death. | one year | 
| heart failure hospitalization | heart failure hospitalization | one year | 
| infection by covid-19 | infection by covid-19 | one year | 
| anaphylaxis required hospitalization | anaphylaxis required hospitalization | one year |
Evaluation of Potential Biomarkers for Obstructive Sleep Apnea and the Effect of Positive Pressure Treatment

Study Overview
=================
Brief Summary
-----------------
Potential biomarkers for obstructive sleep apnea (OSA), and full genomic screening will be evaluated and correlated to the degree of OSA and to effect of CPAP-treatment measured by polygraphy.

Detailed Description
-----------------
This project includes two parts: Genomic screening Biomarkers

Conditions
-----------------
Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
OSA-patients with moderate and severe OSA (n=15+15) Adult, 18-75 years of age Moderate (AHI 15-30) or Severe (AHI >30) OSA that are currently untreated and planned for CPAP-treatment Otherwise healthy except for well controlled hypertension since 3 month, Max BP 140/90 Non-smokers Not pregnant No medications with antioxidants BMI of <40 Controls (AHI<5) Two groups of controls Matched controls The same age, sex and BMI ± 3 and eventual hypertension. These controls should also fulfill criteria 4-6 above. Healthy controls with normal BMI (19-25) These controls should also fulfill criteria 1., 4-6 above. Exclusion Criteria: If they no not fulfil the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Obstructive sleep apnea patients<br>Patients with obstructive sleep apnea that has not received CPAP treatment | |
| Matched volunteers with non OSA<br>Matched volunteers without OSA. Matched in respect to age and BMI | |
| Matched normal controls with normal BMI<br>Volunteers that are matched according to age but has a normal BMI | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker | Biomarkers related to inflammation, hypoxia, oxidative stress, redox and the central nervous system will be measured | Comparison between 0, 3 and 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genomics | Genomic screening by microarray | Comparison between 0, 3, 12 month | 
| Apnea hypopnea index | Apnea hypopnea index at 0, 3 and 12 month after treatment with CPAP in the obstructive sleep apnea groups | Comparision between 0, 3 and 12 month | 
| Exhaled nitric oxide | Measurement of exhaled nitric oxide | Comparision at 0, 3 and 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomarkers, Genomics
BBC ONE - British Bifurcation Coronary Study

Study Overview
=================
Brief Summary
-----------------
The study aims to assess whether a SIMPLE or a COMPLEX strategy is best for the treatment of coronary bifurcation stenoses.

Detailed Description
-----------------
500 patients will be randomised to either a SIMPLE strategy (provisional T stenting) or a COMPLEX strategy (crush or culotte stenting) with clinical follow-up at 9 months.

Official Title
-----------------
British Bifurcation Coronary Study - Old, New and Evolving Strategies.

Conditions
-----------------
Ischaemic Heart Diseases, Stenosis, Angina

Intervention / Treatment
-----------------
* Procedure: Coronary Angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:>18 years Coronary Bifurcation Lesion requiring treatment Exclusion Criteria: Cardiogenic Shock Acute MI Additional type C lesion for Rx platelets <50 LVEF <20%

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Coronary Angioplasty|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  |  | 
| Myocardial infarction |  |  | 
| Target vessel revascularisation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeat angiography |  |  | 
| Stent thrombosis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bifurcation, Coronary, Stenosis, Stent, drug elution
Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the pharmacokinetics of donepezil HCl 3 mg in subjects with end-state renal disease who were receiving haemodialysis.

Detailed Description
-----------------
This is a randomised, single-center, open-label, single-dose, two-period crossover pharmacokinetics study of donepezil HCl tablets 3 mg in subjects receiving haemodialysis. Subjects will be or will not be receiving haemodialysis. After intervals of over 15 days, the subjects will be receiving the other treatment.

Official Title
-----------------
Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.

Conditions
-----------------
End-Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: donepezil HCl
* Drug: donepezil HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Subjects with end-stage renal disease who were receiving haemodialysis. Subject who are able and willing to give written informed consent. Exclusion criteria: Subjects with known hypersensitivity to drugs or foods. Subjects with a corrected QT interval greater than 450 msec at Screening period.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: donepezil HCl<br>* Subjects will receive donepezil HCL 3 mg without haemodialysis. After an interval of over 15 days, the subjects will receive donepezil 3 mg with haemodialysis.<br>|
| Experimental: 2<br> | Drug: donepezil HCl<br>* Subjects will receive donepezil HCl 3 mg with haemodialysis. After an interval of over 15 days, the subjects will receive donepezil 3 mg without haemodialysis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameter: maximum drug concentration in plasma |  | 0-48 hours | 
| Pharmacokinetics parameter: maximum drug concentration time in plasma |  | 0-48 hours | 
| Pharmacokinetics parameter: area under the plasma concentration time curve from Time 0 to 48. |  | 0-48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
end-stage renal disease hemodialysis donepezil hydrochloride pharmacokinetics Cross-Over Study
Individual Patient Compassionate Use of Nirogacestat

Study Overview
=================
Brief Summary
-----------------
This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.

Official Title
-----------------
Individual Patient Compassionate Use of Nirogacestat

Conditions
-----------------
Desmoid Tumor, NOTCH Gene Mutation Positive Tumors

Intervention / Treatment
-----------------
* Drug: Nirogacestat (Gamma Secretase Inhibitor)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a serious, debilitating or life-threatening medical condition with no suitable treatment available, has exhausted current standard of care or declined medically-appropriate treatment for ethical or medical reasons. Patient does not qualify to participate in any ongoing clinical trial sponsored by SpringWorks in an accessible geographical location.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nirogacestat (Gamma Secretase Inhibitor)|Patients will receive nirogacestat tablets to be taken orally.|

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
-----------------
desmoid tumor, aggressive fibromatosis, desmoid fibromatosis, Notch-positive tumors
Do Patient-Centric mHealth Programs Improve Patient Engagement and Health Outcomes.

Study Overview
=================
Brief Summary
-----------------
The INTELLIH (brand name of the mobile health application) Diabetes Study is to understand the usage of a mobile health application, IntelliH, and connected wireless devices such as glucometer by the diabetic patients and ascertain if there are any improvements in short-term health outcomes.

Detailed Description
-----------------
The proposed pilot program is the first of its kind in the nation to use a product, IntelliH - Intelligent Health for All, that combines four key technologies in one platform: 1) Mobile health application (mHealth) App and web portal, 2) wireless sensors and wearable devices, 3) Secure text messaging when both sender and receiver are logged in to the system and video-based patient interaction, and 4) remote health monitoring. The purpose of this pilot program is to understand a) usage and adoption of these technologies by providers and patients, and b) document the short-term improvements in health outcomes in a diabetic population. This pilot study will follow 20 diabetic patients (Type 1 or Type 2) as they beta-test this system, and will acquire data on consented subjects over a period of six months.

Official Title
-----------------
Do Patient-Centric mHealth Programs Improve Patient Engagement and Health Outcomes.

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: IntelliH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A1c greater than or equal to 6.5%. Age greater than or equal to 18 years. Ability to comply with study protocol. Available and usable internet facilities at home. Availability and usable smart phone. Exclusion Criteria: -Inability to comply with instructions and directions.

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

| Intervention/Treatment |
| --- |
|Device: IntelliH|IntelliH is a mobile health and a web-based software application that allows patients to enter their blood glucose, weight, medication, diet and other life-style data for review by their providers and monitor their health remotely.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage and Adoption of the smart phone based mobile health application | Patients adoption will be assessed directly through the application and through questionnaire | Six Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose range maintenance and variation | Frequency of hypoglycemic, hyperglycemic, and out of recommended range events | Six months | 
| Adherence to Prescribed Medication | Medication adherence rates will be measured for each medication used by patient | Six months |
Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
It was conducted a prospective study with a series of 153 patients treated with PRP injections in patient affected by knee osteoarthritis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Score Society (KSS) score and the Visual Analogue Scale (VAS) were evaluated and recorded for each patient at each follow up.

Official Title
-----------------
Clinical Results Of Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis (KOA), Our Experience At Midterm Follow Up

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: PRP injections


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 40 and 81; Body mass index (BMI) between 21.5 and 29.3; Chronic history (for at least 4 months) of knee joint pain; Radiographically documented knee osteoarthritis of grades 1 to 3 (Kellgren-Lawrence (K-L) radiographic classification scale) Exclusion Criteria: Radiographically severe documented knee osteoarthritis of grade 4 (K-L radiographic classification scale); Previous femur and tibia fractures; Knee previous surgical treatment (e.g., arthroscopy); Hyaluronic acid infiltration within the previous six months; Hemoglobin levels <10 g/dL; History of oncohematological disease, infections, or immunodepression

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 81 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 treated by PRP injection<br> | Procedure: PRP injections<br>* The 5 mL PRP concentrate was injected every week for three times, starting from recruitment. The patient was placed supine whit a knee flexion of 90°.All the procedures were carried out in an aseptic condition, injected in the knee soft spot through an anterior approach, using a 21-gauge needle.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analogic Scale | The knee pain was quantified using the Visual Analogic Scale ranging from 0 (no pain) to 10 (worst imaginable pain). | Day 0; Month 1; Month 3; Month 6 (after the injection) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee osteoarthritis (KOA); Platelet-rich plasma (PRP);
Does Laryngoscopic Tecnique Facilitate cLMA Insertion?

Study Overview
=================
Brief Summary
-----------------
it is compared that laryngeal mask insertion with standard technique and laryngoscopic technique

Detailed Description
-----------------
Is there any releation between insertion succes rate and difficult intubation criteria. success of the first attempt laryngeal mask insertion, patient response of laryngeal mask placement. And also during the implementation of these two techniques; the effects on heart rate and blood pressure and postoperative complications were investigated.

Official Title
-----------------
Does Laryngoscopic Tecnique Facilitate cLMA Insertion?

Conditions
-----------------
Urologic Surgery

Intervention / Treatment
-----------------
* Other: Comparison of fibreoptic view


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 age under urologic surgery patient Exclusion Criteria: Uper respiratory infection Full stomach BMI over 40

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cLMA insertion via laryngoscopic technique<br>Comparison of cLMA insertion via laryngoscope view by fiberscope | Other: Comparison of fibreoptic view<br> <br> |
| Active Comparator: cLMA insertion via standart technique<br>Comparison of cLMA insertion via standart technique view by fiberscope | Other: Comparison of fibreoptic view<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| İnvestigate to easy of insertion whether standart or laryngoscopic technique |  | 1 min after insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fiberoptic view |  | 1 min after insertion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cLMA, laryngoscopy, fiberoptic