cyrilzakka/clinical-trials huggingface dataset:
Global SYMPLICITY Registry (GSR) DEFINE

This is a prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document the long-term safety and effectiveness of renal denervation in a real world patient population with hypertension GSR DEFINE is the continuation of the Global SYMPLICITY Registry and collectively will enroll approximately 5000 patients with hypertension who undergo the renal denervation procedure, from over 300 sites worldwide. Subjects included in GSR DEFINE will be followed for a minimum of 1 year and up to 5 years post-procedure. Patients with uncontrolled hypertension will be enrolled in accordance with the inclusion criteria specified in the protocol.

This registry will collect data prospectively on patients that receive renal denervation and treatment will be applied according to the 'Intended Use' in the IFU. The treatment will be performed according to routine hospital practice and no additional tests are required specific to the registry. This registry will serve as a tool to collect clinical data in order to expand the knowledge base of safety, effectiveness and functionality of the Medtronic renal denervation system in a real world patient population.

The key measures collected for the patients will be inclusive of, but are not limited to, blood pressure measurements, change in medications, eGFR changes (based on the MDRD formula) and clinical data pertaining to hypertension .

The inclusion criteria for the registry includes:

* Age ≥ 18 years or minimum age as required by local regulations
* The patient is an acceptable candidate for renal denervation based upon the Instructions For Use for the Medtronic renal denervation system. The procedure must be performed with an initial use, market-released Medtronic renal denervation catheter.
* The patient or legal representative has been informed of the nature of the registry has consented to participate and authorized the collection and release of this medical information by signing a consent form ("Patient Informed Consent Form" or "Patient Data Release Authorization Form")

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years or minimum age as required by local regulations
* The patient is an acceptable candidate for renal denervation based upon the Instructions For Use for the Medtronic renal denervation system. The procedure must be performed with an initial use, market-released Medtronic renal denervation catheter.
* The patient or legal representative has been informed of the nature of the registry has consented to participate and authorized the collection and release of this medical information by signing a consent form ("Patient Informed Consent Form" or "Patient Data Release Authorization Form")
Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer

* To date, Roux-en-Y esophagojejunostomy transabdominal extracorporeally by circular stapler was the most common used method during laparoscopy-assisted total gastrectomy for gastric cancer, even though it was not totally laparoscopic surgery in which intracorporeal anastomosis should be performed.
* To gain potential clinical benefits from a smaller length of minilaparotomy and an easier anastomosis technique than extracorporeal anastomosis, intracorporeal Roux-en-Y anastomosis using a transorally inserted anvil (OrVil™) during totally laparoscopic total gastrectomy was adopted by experienced surgeons recently.
* However, the safety of intracorporeal Roux-en-Y esophagojejunostomy using a transorally inserted anvil (OrVil™) has not yet been evaluated. Thus, the study comparing the safety of intracorporeal versus extracorporeal Roux-en-Y esophagojejunostomy by circular stapler based on a well designed randomized controlled trial is needed.


Eligibility Criteria:
Inclusion Criteria:

* Age from over 18 to under 75 years
* Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy
* Tumor located at middle or upper third of stomach while laparoscopic total gastrectomy is the planning surgery
* Tumor invasion is less than 3cm above the esophagogastric junction
* Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
* ASA (American Society of Anesthesiology) score class I, II, or III
* Written informed consent

Exclusion Criteria:

* Women during pregnancy or breast-feeding
* Severe mental disorder
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* Conversion to open surgery before reconstruction
Hemostatic Compression Patterns After Transradial Coronary Intervention

The purpose of the study is to investigate the protective effects of short term TR Band compression on transradial coronary occlusion after transradial coronary intervention.

Radial artery occlusion (RAO), an infrequent but serious complication after transradial coronary intervention (TRI), prevents subsequent use of the same radial artery for coronary angiography and intervention. Comparing to the overseas counterparts, most Chinese medical workers put more emphasis on prevention of postoperative puncture site bleeding, so longer compression hemostasis time is applied but this prolonged compression may underestimate or even ignore an increasing risk of RAO. Therefore, this study intends to compare short term TR Band compression and the routine long term one on transradial coronary occlusion after transradial coronary intervention.

Participants allocated to the control group will receive a routine long term postoperative puncture site compression via TR Band. In control group, TR Band deflation is commenced at the 2nd hour with successive 5 mL air released at 2 hours intervals until the bladder was empty at the 6th hour, and the TR Band is removed at the 24th hour.

Participants allocated to the experimental group will receive a short term postoperative puncture site compression via TR Band. In experimental group, TR Band deflation is commenced at the 1st hour with 3 mL air released, and at the 2nd hour with 5ml, and at the 3rd hour with the remainder air in the bladder, and the TR Band is removed at the 12th hour.

At the 24th hour, RAO incidence, postoperative puncture site bleeding incidence and patient comfort level will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older
* Patients who received TRI for the first time

Exclusion Criteria:

* Failure to puncture the radial artery in 1 attempt
* Inaccessible radial arteries because of anatomic variations, such as hypoplastic radial arteries and radioulnar loop, which can be confirmed by radial artery angiography before the TRI
* Patients who had previous radial procedure
* Patients who were receiving IIb/IIIa receptor antagonist treatment
Pharmacokinetics in End Stage Renal Disease Patients

The study is a multicentre, open label, phase I, two arms study to compare pharmacokinetic of firibastat after a single oral dose of firibastat 500 mg in fourteen healthy male volunteers and in fourteen End Stage Renal Disease (ESRD) patients not yet in dialysis.

It is planned to enroll a total of 28 subjects to receive a single oral dose of investigational medicinal product (IMP): 14 ESRD patients will be enrolled in three Hungarian centres (1st arm) and 14 Healthy volunteers will be enrolled by Eurofins Optimed in Gières, France (2nd arm).

Subjects will be screened for eligibility to participate in the study up to 21 days prior to the first administration. For both arm, subjects will be admitted into the Clinical Research Unit (CRU) on Day -3. On the morning of Day 1, subjects will receive a single 500 mg oral dose of firibastat following an overnight fast (i.e., at least 10 hours). Subjects will be confined to the CRU until discharge on Day 3 with PK blood sample draws for measurement of firibastat and its main metabolites being taken throughout the confinement.

A follow-up post study visit will occur on Day 10 post-dose to ensure the ongoing wellbeing of the subjects.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects, aged 18 to 55 years inclusive;
* Non-smoker subject or smoker of not more than 5 cigarettes a day;

Exclusion Criteria:

* Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests);
* History or presence of drug or alcohol abuse (alcohol consumption \> 40 grams/day);
Plasma Adiponectin Level and Vascular Endothelial and Smooth Muscle Cell Function in Children With Prader-Willi Syndrome

Context: Prader-Willi syndrome (PWS) is a genetic disorder characterized by childhood-onset obesity and endocrine dysfunction that leads to cardiovascular disability and early death within the first 3 decades of life.

Objectives: To assess the significance of risk factors for future disabilities, carotid artery intima-media thickness (IMT) was measured and correlated with known atherosclerotic risk factors in 27 children with PWS and 24 age-, sex-, and body mass index (BMI)-adjusted controls.

Main outcome measures: Correlation of IMT with age, standard deviation score of BMI (BMI-SDS), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), C-reactive protein, HOMA-IR and ghrelin.

Eligibility Criteria:
Inclusion Criteria:

* obesity with PWS

Exclusion Criteria:

* chronic disease
Ileus After Lumbar Spine Surgery

Postoperative ileus (POI) after lumbar spine surgery is not uncommon. However, the incidence, severity and risk factors of ileus after spine surgery remain uncertain because there is not yet a prospective investigation using a subjective grading evaluation tool.

This study aims to prospectively investigate the incidence of POI after spine surgery by using the I-FEED scoring system. The severity of POI after spine surgery thus could be stratified and then an investigation of possible risk factors could be identified.

Eligibility Criteria:
Adult patients who undergoing elective lumbar spine surgery
mHealth Screening to Prevent Strokes

The purpose of this study is to investigate whether it is possible to identify a high-risk cohort suitable for screening for asymptomatic atrial fibrillation using claims data, and then engage those individuals in a mobile health technology-enabled home monitoring program in order to document previously undiagnosed atrial fibrillation, and provide clinical evidence of an outcomes benefit associated with this early detection.

The purpose of this study is to propose to study two different methods of intermittent rhythm monitoring in a cohort of individuals without prior history of atrial fibrillation, but determined to be at increased risk based on clinical risk factors, and compare the rate of atrial fibrillation detection through monitoring relative to routine care.

Eligibility Criteria:
Participants:

The study population will be derived from the Aetna and Medicare populations.

Inclusion Criteria:

* Male or females age \> 75 or
* Male age \> 55, or females age \> 65, and
* Prior CVA, or
* Heart failure, or
* Diagnosis of both diabetes and hypertension, or
* Mitral valve disease, or
* Left ventricular hypertrophy, or
* COPD requiring home O2, or
* Sleep apnea, or
* History of pulmonary embolism, or
* History of myocardial infarction, or
* Diagnosis of obesity

Exclusion Criteria:

* Current or prior diagnosis of atrial fibrillation, atrial flutter or atrial tachycardia
* Receiving chronic anticoagulation therapy
* Hospice care
* End stage renal disease
* Diagnosis of moderate or greater dementia
* Implantable pacemaker and/or defibrillator
* History of skin allergies to adhesive patches
* Known metastatic cancer
* Aetna Compassionate Care Program (ACCP) participants - individuals with advanced illness and limited life expectancy
Retrospective Analysis Of Progression Free Survival And Overall Survival In A National Cohort Of Patients With Metastatic Renal Cell Carcinoma Treated In Denmark From 2006-2010. DARENCA Study 2.

Non-interventional study. Data obtained by patient chart reviews.

Retrospective analysis of progression free survival, time to treatment failure and overall survival in a national cohort of patients with metastatic renal cell carcinoma treated in Denmark from 2006-2010 Safety, prognostic factors, predictive factors and co-morbidity assessed by Charlson Comorbidity Index.

The following drugs will be evaluated: Sunitinib, Sorafenib, Temsirolimus, Everolimus, Aldesleukin, Interferon-alfa-2b.

No sampling. All eligible patients will be included.

Eligibility Criteria:
Inclusion Criteria:

Metastatic renal cell carcinoma

Exclusion Criteria:

None
Safety, Tolerability and Pharmacokinetics Study of BI 1744 CL in Healthy Male Subjects

To investigate safety, tolerability, and pharmacokinetics (PK) of single i.v. doses of BI 1744 CL


Eligibility Criteria:
Inclusion Criteria:

* Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
* Age ≥21 and ≤45 years
* BMI ≥18.5 and \<30 kg/m2 (Body Mass Index)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
* Evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
* Intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to medication
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to medication
* Participation in another trial with an investigational drug within 2 months prior to medication
* Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
* Inability to refrain from smoking on trial days as judged by the investigator
* Alcohol abuse (more than 40 g alcohol a day)
* Drug abuse
* Blood donation (more than 100 mL blood within 4 weeks prior to medication or during the trial)
* Excessive physical activities within 1 week prior to randomisation or during the trial
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of the study centre.

The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:

* Asthma or history of pulmonary hyperreactivity
* Hyperthyrosis
* Allergic rhinitis in need of treatment
* Clinically relevant cardiac arrhythmia
* Paroxysmal tachycardia (\>100 beats per minute)
Using Intraoperative Sensing Technology to Evaluate Revision Total Knee Arthroplasty

This study will attempt to draw relationships between the soft-tissue related complications contributing to early TKA revision and the loading and positional patterns from intraoperative tibial trial sensors. The data from the sensors may enable the surgeon to address such soft-tissue abnormalities that may otherwise be unknown during traditional total knee revision procedures. The utilization of sensors should in theory, help diagnose the potential causes attributing to soft-tissue imbalance and may lead to a decreased need for an all component revision. Furthermore, the economic implications from converting a total revision to a partial revision could have a profound effect to the patient and healthcare provider such as decreased rehabilitation regimes and opportunity for cost savings. Eligible revision patients who agree to participate will be followed for a period of 12 months following the revision procedure. Patient reported outcomes measures (PROM) such as the 2011 Knee Society Score (KSS) and the Veterans Rand 12-Item Health Survey (VR-12) will be collected at baseline (pre-operatively) and at 6 weeks, 6 months and 12 months post-procedure. All outcomes will be scored to observe changes from baseline at 12-months. Cost-analyses of sensor-assisted revision TKA will be performed to include OR costs, facility and physician fees, as well as payments to post-acute collaborators such as SNFs, rehab hospitals, PT and home care providers. A quantitative analysis of commercial payer claims / usage data (e.g., CMS Medpar data) will be used to examine costs associated with traditional revision TKA procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing revision unilateral total knee arthroplasty within the first 5-years of the index procedure
* Include Male and Female subjects
* Include subjects 18 years and older
* Patients should present with idiopathic pain and/or instability/stiffness attributed to aseptic loosening, polyethylene wear or malrotation
* Patients able to understand study intent, and agree to study participation
* Patients must be previously implanted with the following cruciate-retaining (CR) or posterior-substituting (PS) total knee systems: Stryker TRIATHLON, Zimmer-Biomet VANGUARD or NEXGEN or Smith and Nephew LEGION or JOURNEY II.

Exclusion Criteria:

* No prior revision surgery on operative side
* Ligament insufficiencies, prior surgeries such as PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
* Culture positive aspiration indicating infection of the joint
* ASA class \> III
* History of drug or alcohol abuse
IMRT-SIB and Capecitabine in Preoperative Rectal Cancer Treatment

RATIONALE: Using small radiation beamlets of different intensity, IMRT (intensity modulated radiation therapy) allows shaping the dose around planning target volume with better sparing of normal tissue comparing to 3D conformal radiotherapy. It allows daily delivery of higher dose to the tumor with simultaneous integrated boost (SIB), consequently shortening total treatment time with potentially better response to treatment. In advanced rectal adenocarcinoma excellent response to preoperative radiochemotherapy with complete eradication of the primary tumor observed in the histopathological specimen (pathological complete response, pCR) correlates with a favorable overall prognosis, so trying to achieve better response to preoperative treatment with higher pCR seams feasible.

PURPOSE:The hypothesis of this study is that in preoperative radiochemotherapy for locally advanced rectal adenocarcinoma shortening of the total treatment time with IMRT-SIB to 22 daily fractions concomitant with capecitabine results in an improved pCR rate from 9% (Slovenian trial) to 25%. Secondary objectives are to evaluate pathological down-staging rate, histopathological R0 resection rate, sphincter preservation rate, perioperative surgical complication rate, local control, disease-free survival (DFS), overall survival (OS), late toxicity and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven newly diagnosed primary rectal adenocarcinoma
* Locally advanced tumor fulfilling at least one of the following criteria on pelvic MRI:

  * T ≥ 3 or
  * N ≥ 1
  * Positive mesorectal fascia (MRF), i.e. tumor or lymph node one mm or less from the mesorectal fascia
  * Tumor located od 0 - 15 cm above anocutaneous junction or below peritoneum
* Age 18 years and more
* Signed informed consent
* WHO Performance Status 0-2
* Patients is considered to be mentally and physically ft for chemotherapy as judged by oncologist
* Adequate hematological, hepatic and renal function (WBC ≥ 3.0 x 109/L, neu ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, renal clearance ≥ 50 ml/min, bilirubin ≤ 3x normal value, aspartate transaminase/alanine transaminase (AST/ALT) ≤ 2,5x normal value)

Exclusion Criteria:

* T4 inoperable tumor - extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots
* Metastatic or recurrent rectal cancer
* Other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
* Chronic bowel inflammatory disease
* Pregnant or lactating patient
* Significant heart disease (uncontrolled hypertension despite of medication (\> 150/100 mmHg), New York Heart Association (NYHA) class III or IV heart disease,unstable angina or myocardial infarction within the past 1 year prior the study entry, history of significant ventricular arrhythmia requiring treatment)
* Inability to consciously sign the consent form due to physical or psychological disabilities
The Impact Of Clinical Pharmacists Medication Reconciliation Upon Patients Admission To Reduce Medication Discrepancies.

It is a quazai one arm study shows the impact of the role of the clinical pharmacists through medication reconciliation to patients admitted to the emergency department .The main aim is to show if the pharmacists intervention is associated with establishing a complete drug history list than the list already presented in the patient file and taken by the physician .Then a description of the medication errors detected will be done .

It is a quazai one arm study in which the pre phase is the detection of the complete and accurate drug history list already presented in the patient file and taken by the physician and the post phase is the detection of the complete and accurate drug history list taken by the clinical pharmacists after medication reconciliation for the same patients.

medication reconciliation will be done as a full diseases and preadmission medications history will be taken from the patients or the family through interviews, revising previous prescriptions and hospital records.

* Preadmission medication history will include medications trade names, doses, frequency and route of administration and treatment duration and also will include the consumption of vitamins or herbs.
* The medication errors will be detected ,calculated and classified according to medication at transitions and clinical handoffs (MATCH) toolkit for medication reconciliation and NCC MERP index.

Eligibility Criteria:
Inclusion Criteria:

* Patients with one or more chronic disease / drug.

Exclusion Criteria:

- Patients who cannot communicate or have no family members.
Implementation of Laparoscopy-assisted Surgery for Colon Cancer

The purpose of this study is to study the implementation of laparoscopy-assisted surgery for cure of colon cancer in daily surgical practice.

Prospective observational study of laparoscopy-assisted surgery for resectable colon cancer with regard to short term and long term outcomes

Eligibility Criteria:
Inclusion Criteria:

* Age \>17 years
* diagnosis of colon cancer either endoscopically, radiologically or histologically proven
* No evidence of disseminated disease on CT scan
* T1-3 according to preoperative CT scan
* written informed consent to participate

Exclusion Criteria:

* preoperative diagnosis of locally advanced tumor (T4)
* suspicion of pathological lymph nodes outside anticipated resection area
* contraindications against laparoscopic surgery, e.g. known bowel adhesions, anesthesiological concerns
* lack of informed consent