cyrilzakka/clinical-trials huggingface dataset:
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study

The aim of this study is to develop and validate an improved, comprehensive risk assessment algorithm integrating blood RNA-based biomarkers, clinical, and patient-centered data and to assess the incremental predictive value (discrimination and reclassification) compared to a traditional risk model (change in the c-statistics for prediction of the primary endpoint).

The ORACLE study is a multicenter, observational, prospective, cross-sectional and longitudinal study integrated by 3 different cohorts for 1) RNA biomarker discovery (60 nested case-control sample), 2) model derivation (516 nested case-control sample) and 3) external validation (new prospective cohort of 558 consecutive patients recruited in 4 hospital centers) according to a TRIPOD Statement type 3 analysis. In total 1134 consecutive patients with a HF hospitalization or urgent HF visit \< 30 days before inclusion and followed for 6 months will be studied.

This study include the discovery of novel RNA-based biomarkers using next-generation sequencing technology to define and validate a new biomarker set and clinical and patient-centered risk determinants definition. A new model will be constructed; training and internal validation in the derivation cohort using machine learning methods, and finally an external validation of the new next generation integrative risk assessment model will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Patients with a recent (\<30 days) acute decompensation of HF requiring intravenous diuretic therapy (either hospitalized or in ambulatory care) or intensification of oral diuretics (ambulatory care).
* HF diagnosis according to European Society of Cardiology (ESC) criteria.
* Written informed consent
* Patients receiving oral standard medication for chronic HF.

Exclusion Criteria:

* Age\<18 years old.
* Death before hospital discharge.
* The patient is unable or unwilling to give the informed consent to participate.
* Unstable patients with signs of fluid overload or low cardiac output at the moment of enrollment.
Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis

This study aims to provide a holistic assessment of patients receiving etanercept in a real-world setting.

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ankylosing spondylitis (AS)

Exclusion Criteria:

* Hypersensitivity to etanercept
* Active infection including chronic or localised infection
* Sepsis or risk of sepsis
Liposome Bupivacaine Interscalene Total Shoulder

This is a randomized prospective outcomes study comparing two groups of patients. One group will receive liposomal bupivacaine plus bupivacaine and the other will receive bupivacaine alone in interscalene blocks when undergoing total shoulder arthroplasty. The purpose of the study is to determine if LB plus bupivacaine provides superior pain control compared to bupivacaine alone when injected in an interscalene block for patients undergoing total shoulder arthroplasty surgery.

Liposomal bupivacaine (LB) is a long acting local anesthetic. It is liposome encapsulated bupivacaine which allows for prolonged release of bupivacaine over a 72-hour period. Bupivacaine is a medium acting local anesthetic which provides between 6 and 24 hours of analgesia when used in a peripheral nerve block. Both medications are standard of care for use in interscalene blocks here at the U of MN.

LB has not been adequately studied in peripheral nerve blocks and has yet to be studied for use in interscalene blocks for Total Shoulder Arthroplasty (TSA) patients. It has been studied in Rotator Cuff Repairs (RCR) surgery and showed superior analgesia compared to bupivacaine.

The purpose of the study is to determine if LB plus bupivacaine provides superior pain control compared to bupivacaine alone when injected in an interscalene block for patients undergoing total shoulder arthroplasty surgery.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients aged greater than 18 years of age that are undergoing total or reverse total shoulder arthroplasty

Exclusion Criteria:

* Patients with allergy to local anesthetics, daily use of opioids for more than 3 weeks prior to surgery, patient refusal, patient with coagulopathy, non-english speaking patients, and those who do not have access to a telephone.
Impact of Significant Carotid Stenosis on Retinal Perfusion Measured Via Automated Retinal Oximetry

Background: Large vessel carotid stenosis represent significant cause of ischaemic stroke. Indication for surgical revascularisation treatment relies on severity stenosis and clinical symptoms. Mild clinical symptoms such as transient ischemic attack, amaurosis fugax or minor stroke preceded large strokes in only 15% of cases.

Aim: The aim of this prospective study is to evaluate whether retinal perfusion is impacted in significant carotid stenosis. Automated retinal oximetry could be used to better evaluate perfusion in post-stenotic basin. The investigators presume the more stenotic blood vessel, the more reduced retinal perfusion is resulting in adaptive changes such as higher arteriovenous saturation difference due to greater oxygen extraction. This could help broaden the indication spectrum for revascularisation treatment for carotid stenosis.

Methods: The investigators plan to enroll 50 patients a year with significant carotid stenosis and cross-examine them with retinal oximetry. Study group will provide both stenotic vessels and non-stenotic vessels forming the control group. Patients with significant carotid stenosis will undergo an MRI examination to determine the presence of asymptomatic recent ischaemic lesions in the stenotic basin, and the correlation to oximetry parameters.

Statistics: Correlation between the severity of stenosis and retinal oximetry parameters will be compared to the control group of non-stenotic sides with threshold of 70%, respectively 80% and 90% stenosis. Data will be statistically evaluated at the 5% level of statistical significance. Results will be then reevaluated with emphasis on MRI findings in the carotid basin.

Conclusion: This prospective case control study protocol wil be used to launch a trial assessing the relationship between significant carotid stenosis and retinal perfusion measured via automated retinal oximetry.


Eligibility Criteria:
Inclusion Criteria:

Study population will include patients examined in ultrasound laboratory in Neurology department of University Hospital Olomouc, regardless of incidental finding of stenosis, examination due to acute symptoms or regular checkup of known stenosis.

Exclusion Criteria:

* patients unable undergo ophthalmological examination properly, especially on automated retinal oximetry.
Effect of Football on the Musculoskeletal System and Hormonal System

Several studies have shown that football practice regulates bone remodeling, producing an increase of bone mineral density and reducing the risk of fractures. Thus, the aim of this study is to evaluate the effect of football practice on the regulation of bone turnover in Spanish adult football players. Thanks to the collaboration agreement "Aula Endavant" the Villarreal CF participates as a collaborator in this Project. This agreement allows us to use their facilities and to analyze several football players' data.

Several studies have shown that football practice regulates bone remodeling, producing an increase of bone mineral density and reducing the risk of fractures. These studies are mainly performed in adolescents and there are few results obtained from European adults subjects. Thus, the aim of this study is to evaluate the effect of football practice on the regulation of bone turnover in Spanish adult football players. Secondary objectives include: describing bone mineral density values, evaluating percentage of total lean mass and body fat, describing dietary and physical habits and analyzing blood tests of professional football players. As well as, they include updating the current state of knowledge of the influence of sports on bone. Thanks to the collaboration agreement "Aula Endavant" the Villarreal CF participates as a collaborator in this Project. This agreement allows us to use their facilities and to analyze several football players' data. In addition, different members of the club will directly participate as researchers during the development of this study.

One of the strengths of this study is that the data were obtained from two consecutive seasons of an elite soccer team.

One of the potential limitations that we have faced in this study is that in order to obtain a large sample, it is necessary to analyse the soccers from two consecutive seasons, which makes the study temporarily longer than desired.

Eligibility Criteria:
Inclusion Criteria:

* male gender
* aged between 18 and 40 years
* who practice soccer for more than 6 hours / week from the age of 10 to the present.

Exclusion Criteria:

* play other elite sports than soccer
* play 6 or more hours of recreational sports per week
* smokers
* individuals with chronic cardiovascular diseases, hypo and hyperthyroidism, hypertension, rheumatoid arthritis and osteoarthritis
Evaluation of the Diagnostic Potential of BAY1006578 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of BAY1006578 in Healthy Volunteers

PET (positron emission tomography) imaging with BAY1006578 for investigation of diagnostic potential in probable Alzheimer Disease patients versus healthy volunteers and radiation dosimetry in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* All:

  * Males or females aged \>/- 50 years
  * Participants must be able to understand the information provided on purpose and conduct of the clinical study, must be capable of giving fully informed consent in writing, and have read and signed the informed consent prior to study participation
* Healthy volunteers for brain imaging:

  * Mini-Mental State Examination (MMSE) score of \>/= 28
  * CDR score of zero (0)
* Patients for brain imaging:

  * Patient fulfills Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and National Institute of Neurological and Communicative Disorders and Stroke, Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable Alzheimer's Disease (AD), which are cognitive deficits such as memory decline and impairment in at least one other cognitive domain (e.g. aphasia, apraxia, agnosia or executive dysfunction)
  * Patient has mild to moderate dementia with a dementia score of \>/= 20 on the Mini Mental State Examination (MMSE) / with a Clinical Dementia Rating score of 1 or 2 (CDR)

Exclusion Criteria:

* All:

  * No significant disease or drug use
* Patients for brain imaging:

  * Evidence for any other neurological or psychiatric disease
* Healthy volunteers for brain imaging:

  * Family history of Alzheimer's Disease in a 1st or 2nd degree relative under 75 years of age
Debridement, Antibiotics and Implant Retention in Early Periprosthetic Joint Infection: A Retrospective Cohort Study

Introduction: Periprosthetic joint infection (PJI) is a common cause for reoperation after knee and hip arthroplasty surgery. Debridement, antibiotics and implant retention (DAIR) is recommended in early infections (\< 4 weeks) and stable implants. Aims: To define the success rate of DAIR in early infections and to identify predictors for success. Material and methods: In a retrospective cohort study we included patients with hip- or knee arthroplasties reoperated for an early PJI at Danderyd Hospital 2007-2012. Logistic regression analysis was used to identify risk factors affecting success rate. Primary outcome variable was the success of the DAIR treatment. Secondary outcome variable vas risk factors for treatment failure.


Eligibility Criteria:
Inclusion Criteria:

Patients treated with DAIR for early postoperative periprosthetic joint infection after knee- or hip arthroplasty surgery (\<4-6 weeks postoperatively) at our institution between 2007-01-01 and 2012-12-01.

Exclusion Criteria:

Chronic or late presenting periprosthetic joint infection (\>6 weeks postoperatively), acute hematogenous periprosthetic joint infection, when the periprosthetic joint infection diagnosis criteria according to American Musculoskeletal Infection Society (MSIS) 2011 definition of PJI definitions were not fulfilled and when the initial surgical treatment was with other treatment protocol than DAIR including one-stage revision and two -stage revision
Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants

Safety and efficacy of BG9924 in RA participants that have had an inadequate response to disease-modifying anti-rheumatic drug (DMARD) therapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of RA (functional class I - III)
* Stable dose of MTX
* Inadequate response to at least one conventional DMARD therapy

Key Exclusion Criteria:

* Serious local infection or systemic infection
* History (Hx) of recurrent infections requiring oral or parenteral anti-infective treatment
* Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period
* Clinical significant lab tests at screening
* Positive for Hep C or Hep B at screening

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Multi-Omics Testing for Immunotherapy Efficacy Evaluation (MOTIVATION)

This multicenter prospective observational and exploratory study aims to develop and validate a novel multi-omics-based computational method for neoantigen prediction in non-small cell lung cancer (NSCLC), and discover biomarkers for evaluation of PD-1/PD-L1 inhibitor's efficacy in patients of advanced NSCLC.

Tumor tissues and blood samples from about 400 patients with non-small-cell lung cancer (NSCLC) will be collected for the study, which will be subject to NGS-based genomic, transcriptomic, and methylomic profiling in order to construct a multi-omics landscape of NSCLC. These multi-omics data will be used to construct and validate a novel computational method for neoantigen prediction. Additionally, biomarkers will be explored for prognosis and patient stratification, as well as for evaluation of PD-1/PD-L1 inhibitor treatment efficacy in patients of advanced NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stage I-IV non-small cell lung cancer(with no restriction of age, gender, or smoking history)
* Patients in the group will be allowed to collect whole blood and tissue samples at specific time points
* Eastern Cooperative Oncology Group Performance Status of 0-1 within 28 days prior to registration
* No previous systemic anti-tumor therapy
* Signed informed consent

Exclusion Criteria:

* Active or history of autoimmune disease or immune deficiency
* Patients with serious mental disease
* Prior allogeneic stem cell or solid organ transplantation
* Pregnant or lactating women
* Patients who cannot obtain tumor tissue samples and / or whole blood
* Patients with history of blood transfusion within half a year
* Patients with any other malignancy diagnosed within 5 years
* Received systemic anti-tumor therapy
Post- Thoracotomy Paravertebral Block

Postoperative pain is the most undesired consequence of surgery, and if not managed adequately, can lead to delayed recovery and increased hospital stay. Surveys continue to reveal that postoperative pain is insufficiently managed throughout the first world, let alone in the Third World. An American survey over 20 years showed that only one in four patients had adequate relief of postoperative pain. This has led recovery room protocols to include pain as a fifth vital sign that needs to be addressed before patients are discharged to the ward

This prospective, randomized, double-blinded, parallel assignment clinical trial will be done after receiving approval from the local ethics committee of the Faculty of Medicine, Assiut University. A written informed consent will be taken after discussing a detailed description of the study with the patients.

Patients will be allocated randomly into two equal groups by computer programs and will be contained in sealed opaque envelopes.

Patients will be premedicated with midazolam (0.1mg/kg), 30 min before the operation. Patients will be monitored with ECG, non-invasive blood pressure, heart rate, temperature, oxygen saturation, exhaled CO2 (end tidal capnography), and train of four. In both groups, general anesthesia will be induced with propofol (2mg/kg) and fentanyl (1 mcg/kg). Tracheal intubation will be facilitated with cisatracurium 0.1 mg/kg. Anesthesia will be maintained with isoflurane (1-2 %) and cisatracurium (0.05 mg/kg per dose). Fentanyl (0.5mcg/kg) will be repeated if heart rate (HR) and/or mean arterial pressure (MAP) rise 20 % above baseline values. After the end of anesthesia induction and before surgical procedure Technique of ultrasound guided paravertebral block will be done in both groups.

Eligibility Criteria:
Inclusion Criteria:

1. ASA I, II and III.
2. In the age ranged between 18 up to 60 years.
3. Elective video-assisted thoracoscopy

Exclusion Criteria:

1. ASA IV and V
2. Liver impairment
3. Renal impairment
4. allergy to the drugs used
5. Known contraindication for regional techniques such as:

   * Infection near the site of the needle insertion
   * Coagulopathy
   * Anti-coagulation therapy,
C3 Total Joint Patient Registry

This study will assess the efficacy of products, implants, and procedures for knee and hip replacement.

This registry will prospectively collect a core set of data on patients undergoing knee or hip replacement. This registry will include a variety of different products, implants, technologies and procedures. The registry will also collect any adverse events/complications that occur during or following these surgeries. This database can also be utilized in the future to answer research questions, by retrospectively going back through the data. This information also may go to insurance companies or hospitals for quality measurement and metrics reporting. The data will be utilized to develop strategic treatment pathways that will improve patient care. Ultimately, the goal of the registry is to enhance the understanding of treatment associated with knee and hip replacement and the resulting patient outcomes. The registry will also be used to provide quality measurement and metrics reporting.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Undergoing knee or hip replacement
* Subject is likely to follow standard of care post-operative follow up for at least 1 year

Exclusion Criteria:

* Inability to complete follow-up visits or required questionnaires
* Inability to provide informed consent without a legally authorized representative
(DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings

This study is conducted to evaluate validity of Diabetes Risk Assessment in Dentistry Score (DDS) in Indian population as a screening tool to identify patients with prediabetes and undiagnosed type 2 diabetes in dental setting. The DDS score of the patient will be correlated with the HbA1c levels and periodontal status of the patient. Such a study has been conducted in Germany but none has been validated in Indian population. Hence this study aims to assess the performance of DDS screening tool in Indian population.

BACKGROUND- Most of the models for T2DM risk assessment exist for use in medical settings and include data which is commonly unavailable to dentists. To overcome the limitation of applicability of existing diabetes-risk assessment tools in dental settings, the Diabetes Risk Assessment in Dentistry Score (DDS) was developed utilizing measures routinely available to dentists. It has been developed and validated in a German population and found to perform broadly at par with those validated for use in medical settings. RATIONALE-Models developed in a specific population need to be validated in other populations before they can be adopted. The DDS screening tool has not been validated in Indian population till date. OBJECTIVES- To assess performance of DDS screening tool in predicting the risk of prediabetes and type 2 diabetes mellitus among individuals seeking dental consultation in Indian population. METHODS-The study participants will include individuals seeking dental consultation at a university teaching hospital in India. All participants will undergo DDS risk-assessment followed by measurement of serum HbA1c levels to establish diagnosis of health, prediabetes or undiagnosed T2DM. EXPECTED OUTCOMES-It is expected that the DDS screening model performs well in Indian population, with scope for incorporation of the model during regular dental visits.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria-adults aged ≥ 40 years

Exclusion Criteria:

* Individuals with existing physician-diagnosed diabetes (of any kind)
* Pregnant females
Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients

The purpose of this study is to assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Serum phosphate levels: \>5.0 mg/dL and \<11.0 mg/dL 2 weeks after the initiation of the washout period
* Out-patient
* Undergoing CAPD for at least previous 3 consecutive months

Exclusion Criteria:

* Who may not enable to continue CAPD
* Serum phosphate levels of \>=10.0 mg/dL at the start of the washout period or \>=11.0 mg/dL 2 week after
* Corrected serum calcium level of \<7.0 mg/dL at the start of the washout period or \>=11.0 mg/dL 2 week after
* Serum intact PTH (Parathyroid) of \>=1000 pg/mL at the start of the washout period
* Pregnant woman, or lactating mother
* Significant gastrointestinal disorders including known acute peptic ulcer
* Liver dysfunction
* History of cardiovascular or cerebrovascular diseases