linjc16/ctgov huggingface dataset:
Characterizing Recurrent Thromboembolism, Major Bleeding and All-Cause Death in Patients With Cancer-Associated Thromboembolism Treated With Rivaroxaban

Study Overview
=================
Brief Summary
-----------------
To estimate the real-world rates of recurrent Venous thromboembolism (VTE), major bleeding and all-cause mortality in patients with Cancer-associated thrombosis (CAT) treated with rivaroxaban

Official Title
-----------------
Characterizing Recurrent Thromboembolism, Major Bleeding and All-Cause Death in Patients With Cancer-Associated Thromboembolism Treated With Rivaroxaban

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (≥18 years-of-age) with active cancer Patient with at least one index venous thromboembolism (VTE ) ≥6-months of continuous eligibility prior to the index VTE event (baseline period). Newly initiated on rivaroxaban Exclusion Criteria: Patients with any medical claim for Deep vein thrombosis (DVT) or Pulmonary embolism (PE) during the 6 months pre-index date Patients with prescription claim for anticoagulation therapy during the 6-month pre-index VTE period

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 |
| --- | --- |
| Cancer-associated thrombosis<br>Adult patients with active cancer with at least one index venous thromboembolism (VTE) and no anticoagulation use during the 6-months (baseline period) prior to the index VTE event | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* 15/20 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent Venous thromboembolism | Derived using inpatient and outpatient medical claims | Retrospective analysis from November 2012 through September 2015 | 
| Bleeding (based on the Cunningham algorithm) | Derived using inpatient and outpatient medical claims | Retrospective analysis from November 2012 through September 2015 | 
| Mortality (In-hospital mortality or need for hospice care without subsequent healthcare claims) | Derived using inpatient and outpatient medical claims | Retrospective analysis from November 2012 through September 2015 |
The Role of the Upper Colliculus in the Idiopathic Blepharospasm

Study Overview
=================
Brief Summary
-----------------
This pilot study aims at investigating the role of superior colliculus in patients with idiopathic blepharospasm (BSP) de novo, compared to healthy subjects.

Detailed Description
-----------------
The objective of the study is to investigate the function of the superior colliculus (SC) related to visual stimulation by means of fMRI (functional magnetic resonance imaging) in patients with idiopathic BSP compared to healthy subjects. The hypothesis is that SC function is impaired in BSP (role of biomarker of SC).

Official Title
-----------------
The Role of the Upper Colliculus in the Idiopathic Blepharospasm : a Pilot Study in Functional MRI

Conditions
-----------------
Blepharospasm, Benign Essential

Intervention / Treatment
-----------------
* Other: fMRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non treated idiopathic blepharospasm Age: 30- 70 years Exclusion Criteria: Under the following treatments: Botulin toxin, anticholinergic, benzodiazepines, baclofen, beta- and alpha-blockers collyrium No MRI Contraindication

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: idiopathic blepharospasm (BSP) de novo<br>bold signal in visual pathway | Other: fMRI<br>* bold signal in visual pathway<br>|
| Other: Healthy subjects<br>bold signal in visual pathway | Other: fMRI<br>* bold signal in visual pathway<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual pathways fMRI | To measure the bold signal in superior colliculus and lateral geniculate corpus | In a five months period after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Superior colliculus, fMRI
Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis

Study Overview
=================
Brief Summary
-----------------
The anomalous origin of right coronary artery (RCA) is a rare coronary anomaly. Recently, the detection of this anomaly has been more frequent as the use of cardiac multidetector computed tomography has become more popular. It can cause myocardial ischemia, syncope and sudden cardiac death. Surgical repair is generally recommended for symptomatic patients. However, there is controversy concerning the proper evaluation and treatment strategy for patients without documented myocardial ischemia. The stenotic lesion of anomalous origin of RCA will be assessed by fractional flow reserve (FFR).

Official Title
-----------------
Physiologic Evaluation of Anomalous Right Coronary Artery Stenosis

Conditions
-----------------
Coronary Vessel Anomalies

Intervention / Treatment
-----------------
* Procedure: revascularization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed as anomalous origin of right coronary artery from left coronary cusp Exclusion Criteria: poor compliance need for percutaneous coronary intervention to significant coronary lesion failure of FFR for anomalous origin of right coronary artery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low FFR<br>FFR<0.75 | Procedure: revascularization<br>* surgery or stenting<br>* Other names: other names are not available;|
| No Intervention: high FFR<br>FFR > 0.75 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac death |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Vessel Anomalies
Post-marketing Study to Collect Safety Data in Heart Transplant Patients Receiving Everolimus

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational protocol is to evaluate the use of everolimus in routine clinical practice for heart transplants. Primary outcome measures: incidence of acute rejection episodes Secondary outcomes: safety

Official Title
-----------------
A Non-interventional Protocol to Collect Prospective and Retrospective Data in Patients Receiving Everolimus to Prevent Acute Rejection Following Cardiac Transplantation

Conditions
-----------------
Coronary Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac transplant recipients Discharged alive from hospital Must be receiving everolimus Exclusion Criteria: Patients not treated with everolimus beginning within 2 weeks after receiving a heart transplant Other inclusion/exclusion criteria may apply.

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?
-----------------
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
-----------------
Transplantation, heart, Organ transplant
Bariatric Surgery and Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
More often than not, obesity occurs in tandem with Obstructive Sleep Apnea (OSA), and each disease effectively perpetuates severity of the other. Surgical weight loss (i.e. bariatric surgery), and nocturnal, positive airway pressure therapy (PAP) are used to treat the two conditions separately, and these treatment modalities both present a unique set of challenges in terms of patient-adherence. Furthermore, the combined effects of these therapies on body weight and OSA severity are unclear, and require longitudinal investigation. The purpose of the research proposed herein is twofold: A) To prospectively demonstrate the specific physiologic/psychological improvements in OSA risk factors and disease severity that occur in a subset of bariatric surgery patients with OSA, who are being effectively treated with PAP and furthermore; B) To elucidate differences in postoperative outcomes (weight-loss, dyslipidemia, OSA severity, comorbidity resolution) between patients who are compliant or non-compliant with prescribed PAP therapy. The investigators anticipate that results will be used to develop and streamline approaches to improve pulmonary/sleep-related outcomes in bariatric surgery patients. Furthermore, this line of research has many implications for strategies to strengthen the coordination of care between bariatric surgery, pulmonology, and other clinical sub-specialties that are integral to the postoperative health of these patients.

Official Title
-----------------
Effects of Bariatric Surgery on Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea, Bariatric Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese (Body Mass Index > 35) pending laparoscopic roux-en-Y gastric bypass at Summa Bariatric Care Center women ages 20 - 85 diagnosed OSA and prescribed nocturnal, autotitrating positive airway pressure therapy Exclusion Criteria: are excluded if failure to meet any of the above

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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 |
| --- | --- | --- |
Kidney Histopathology After COVID-19 and SARS-CoV-2 Vaccination

Study Overview
=================
Brief Summary
-----------------
The study aims to summarize kidney histopathological findings in patients with coronavirus disease 2019 (COVID-19) and post-severe acute respiratory syndrome-coronavirus-type 2 (SARS-CoV-2) vaccination.

Detailed Description
-----------------
The SARS-CoV-2 pandemic has had substantial global morbidity and mortality. While COVID-19 is most commonly characterized as a respiratory illness, extrapulmonary manifestations are a prominent part its clinical spectrum. Kidney disease is a common finding in COVID-19, and has also been rarely described after SARS-CoV-2 vaccination. The main objective of this study is to summarize kidney histopathological findings in patients with COVID-19 and post-SARS-COV-2 vaccination, in whom native kidney biopsy was performed and samples were obtained by the Nephropathology Section, Institute of Pathology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Official Title
-----------------
Kidney Histopathological Features in Patients After COVID-19 and SARS-CoV-2 Vaccination

Conditions
-----------------
Covid19, Vaccination Reaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being diagnosed with COVID-19 when kidney biopsy was performed history of recent homologous or heterogenous vaccine regimen comprising either vector-based vaccines or messenger ribonucleic acid-based vaccines Exclusion Criteria: Patient refuses participation

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with COVID-19<br>Polymerase Chain Reaction-positive SARS-CoV-2 infection | |
| Patients post-SARS-CoV-2 vaccination<br>Onset of kidney disease potentially relatable to SARS-CoV-2 vaccination based on clinical grounds | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of histopathologically confirmed glomerular and tubulointerstitial diseases |  | Kidney biopsy obtained during COVID-19 disease and up to 3 months after SARS-CoV-2 vaccination |
A Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of single-agent AT-101 in men with hormone-refractory prostate cancer.

Official Title
-----------------
An Open-Label, Multicenter, Phase I/II Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer (HRPC) and Rising Prostate Specific Antigen (PSA) Levels Who Have Not Received Prior Chemotherapy

Conditions
-----------------
Hormone Refractory Prostate Cancer

Intervention / Treatment
-----------------
* Drug: AT-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rising PSA, as defined by increasing levels on at least two consecutive assessments ECOG performance status 0 or 1 Adequate hematologic function Adequate liver and renal function Able to swallow and retain oral medication. Exclusion Criteria: Received prior chemotherapy for HRPC. Concurrent therapy for the treatment of prostate cancer. Clinical signs or symptoms of CNS metastases Requirement for corticosteroid treatment, with the exception of topical corticosteroids or inhaled corticosteroids for reactive airway disease. Active secondary malignancy or history of other malignancy within the last 5 years. Failure to recover from toxicities related to prior therapy. Uncontrolled concurrent illness.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AT-101|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete or partial remission of disease |  |  |
Study Evaluating AGG-523 in Subjects With Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effect of AGG-523 administration on biomarkers related to osteoarthritis. Safety and tolerability of AGG-523 will also be assessed.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel-Group Study of the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of AGG-523 Administered Orally to Subjects With Mild to Moderate Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: AGG-523


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Mild to moderate Osteoarthritis of the target knee. Subjects must be generally healthy but enrolled with stable chronic illness if well controlled.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: AGG-523|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of AGG-523 on biomarkers related to osteoarthritis. |  |  |
Differentiation of Aseptic From Septic Loosening by 18F-fluoride PET

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators utilized the 18F-fluoride PET method to evaluate THA cases with a stable, septic or septic loosened implant in order to differentiate these clinical settings using a novel uptake type classification approach.

Official Title
-----------------
Differentiation of Aseptic From Septic Loosening in Patients With Total Hip Arthroplasty Using 18F-fluoride PET

Conditions
-----------------
Hip Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Within one year after surgery
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| condition of joint implant<br> | |

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
-----------------
To clarify the 18F-fluoride uptake patterns associated with aseptic or septic loosening
Degarelix Before Radical Prostatectomy

Study Overview
=================
Brief Summary
-----------------
The biological effects of castration on prostate cancers will be studies by administration of degarelix prior to radical prostatectomy. The effects will be studied by analysis of gene expression and immunohistochemistry focusing on markers of proliferation and apoptosis of samples taken at the time of radical prostatectomy (7 days after administration of degarelix). Tumours from patients treated with neo-adjuvant degarelix will be compared with tumours from patients who have not been medically castrated.

Official Title
-----------------
A Study of the Early Biological Effects of Testosterone Suppression in Prostate Cancer Using Neoadjuvant Degarelix Prior to Radical Prostatectomy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: 240mg degarelix s.c. injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intermediate/high risk prostate cancer Patient eligible for and wanting surgery Exclusion Criteria: Inability to consent Previous thromboembolism/arrhythmias contraindication to degarelix or surgery

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

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

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 |
| --- | --- |
| Experimental: Degarelix treated group<br>240mg degarelix s.c. injection to be administered 7 days prior to radical prostatectomy for high/intermediate risk prostate cancer. | Drug: 240mg degarelix s.c. injection<br>* 7 days prior to radical prostatectomy the patient will have a subcutaneous injection of 240mg degarelix.<br>* Other names: medical castration;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proliferative index defined by immunohistochemistry for ki67 |  | at surgery, 7 days after administration of degarelix | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression levels measured by microarray |  | At surgery 7 days after degarelix administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, testosterone, castration, degarelix, proliferation