cyrilzakka/clinical-trials huggingface dataset:
Tachy Prediction Download Study

The purpose of the Medtronic Tachy Prediction Download (TPD) study is to collect data from an implantable cardiac defibrillator (ICD) device that will be used to identify markers for imminent onset of ventricular arrhythmias.

The TPD Study is a prospective, non-randomized, non-interventional, multi-site data collection clinical study to collect ICD longitudinal data that may be used to develop a VT/VF prediction algorithm. The study subjects will include patients currently implanted, or who will be implanted with a market-approved Medtronic Evera MRI® ICD.

Eligibility Criteria:
Inclusion Criteria:

* Subject is implanted or will be implanted, with an Evera MRI device with properly functioning Medtronic tachycardia lead placed in the right ventricle (with or without atrial lead) with remaining device longevity of 4 years or more for:

  * Secondary Prevention or,
  * Primary Prevention and has had a device treated VT/VF or a device recorded episode of sustained VT/VF
* Subject is ≥ 18 years old
* Subject has previously documented history of VT/VF
* Subject must be willing and able to use Medtronic CareLink network monitoring system
* Subject provides signed and dated authorization and/or consent per institution and local requirements
* Subject is willing and able to comply with the protocol

Exclusion Criteria:

* Subject who received device for Primary Prevention indication and who has not had either a device treated VT/VF episode or a device recorded episode of sustained VT/VF
* Subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
* Subject has chronic AF
* Subject has inherited disorders of ion transport mechanisms that predispose the subject to sudden death ("Channelopathies"): Long QT and Brugada Syndromes
* Subject with multiple implanted active devices that may cause an interruption of a transmission of device data to CareLink
* Subject has active electronic medical device other than an ICD
* Subject requires more than 25% atrial or ventricular pacing
* Subject has medical conditions that would limit study participation (per investigator judgment)
* Subject has projected life expectancy of less than 1 year
* Subject is pregnant or plans to be pregnant over the next year (females of child-bearing potential must have a negative pregnancy test within one week of enrollment and must practice a reliable form of birth control while enrolled in the study)
* Subject meets exclusion criteria required by local law (e.g. age, breastfeeding, etc.)
A Comparison of MRI Perfusion and FDG PET/CT to Distinguish Between Radiation Injury and Tumor Progression

This study will examine if MRI perfusion and PET/CT can tell growing tumor and radiation injury apart. MRI perfusion looks at the blood vessels in the tumor. PET/CT looks if the tumor cells are actively growing. The investigators will do these two tests and see which one is better.

Patients will remain on study until the completion of either the MRI perfusion or PET/CT that are within 12 weeks of each other. After one of these scans, the patient will have no active interventions and will be off study.

Optional: Restriction Spectrum Imaging (RSI) Sequence RSI sequence is an advanced way of looking at your brain. The scan allows doctors to see how water is moving within brain tumors or within brain cells. The extra sequence takes additional 4-5 minutes in the scanner. The RSI sequence is optional. The patient will only be asked to participate if the doctor believes that it will be helpful.

Off study: Patients will remain on study until the completion of either the MRI perfusion or PET/CT that are within 12 weeks of each other. After one of these scans, the patient will have no active interventions and will be off study. Patients will obtain a standard of care brain MRI scan about every 2-3 months. These MRI scans will be used to track disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Pathological or clinical/radiological diagnosis of aneoplasm , either primary (e.g., malignant glioma) or secondary (metastasis from systemic malignancy) with a history of brain radiation therapy
* Completed fractionated radiation therapy (to 60 Gy for high grade gliomas) or stereotactic radiosurgery or hypofractionated radiation therapy (e.g. for brain metastases, anaplastic meningiomas), without or with concurrent chemotherapy
* New or increased enhancing brain lesion(s) OR nonenhancing brain lesion(s) if receiving anti-angiogenic therapy, which is considered indeterminate for tumor progression vs. radiation injury by the neuroradiologist or clinician
* Patient and/or guardian is able to provide written informed consent prior to study registration
* Age ≥ 18 years old

Exclusion Criteria:

* Claustrophobia
* Known allergic reaction to Gd-DTPA
* Any contraindication to gadolinium intravenous contrast as per standard Department of Radiology contrast guidelines
* Any contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander).
* Pregnant or nursing female
* Unable to cooperate for MRI and/or PET/CT
Empirical Mode Decomposition and Decision Tree in Sarcopenia

Sarcopenia is quickly becoming a major global public health issue. Falls are the leading cause of mortality among the elderly, and they must be addressed. The investigators will use machine learning techniques such as empirical mode decomposition technology and decision tree algorithms to extract the characteristics and classification of sarcopenia in this retrospective study in order to offer clinically proven and effective interventional strategies to prevent, stabilize, and reverse sarcopenia.

Sarcopenia is becoming a severe global public health concern as the world's elderly population grows. Sarcopenia is characterized by muscular mass and strength loss, as well as impaired physical performance, and it is frequently connected with negative health outcomes such as falls. Falls are a primary cause of death in older individuals and must be addressed. Sarcopenia is currently diagnosed clinically using three primary technologies: imaging technology, precision medicine, and machine learning. In this study, the investigators will use previously collected data from nearly 200 community-dwelling subjects, including medical history, biochemistry, body composition, balance and gait, electromyography, and functional performance, to extract the characteristics and classification of sarcopenia using machine learning techniques such as empirical mode decomposition technology and decision tree algorithms. The investigators intend to offer clinically proven and effective interventional strategies to prevent, stabilize, and reverse sarcopenia.

Eligibility Criteria:
Inclusion Criteria:

* aged from 40 - 90
* DXA test performed
* blood sample tests were performed

Exclusion Criteria:

* stroke history
* amputation
* cancer related disease
Pulmonary Tuberculosis Patients With Diabetes Mellitus

The purpose of this study is to evaluate the effect of enhanced glycemic monitoring of diabetes upon diabetes glycaemic control during tuberculosis treatment in tuberculosis- diabetes patients.

Tight glycemic control may improve tuberculosis (TB) treatment outcome and help reduce symptoms. However, active TB and TB treatment hamper glycemic control. Patients starting TB treatment experience rapid changes in appetite, body composition, and inflammation (which increases insulin resistance); inflammation is a feature of untreated TB and following an increase as a result of initial bacterial killing, inflammation subsides with successful treatment. In addition, TB medication (rifampicin) increases the metabolism of oral anti-diabetic drugs including the widely used sulphonylureas and thiazolidinediones, though a possible interaction with the antidiabetic drug metformin has not been previously examined. Frequent monitoring of blood glucose with adjustments in anti-diabetes medication during the course of TB treatment may therefore be needed. However, frequent monitoring is associated with additional costs, and tools and skills for glucose monitoring and diabetes treatment may be lacking in TB or pulmonary clinics, creating a need to refer patients to other health providers. As such, a less intense schedule, preferably following the established decision points in TB treatment after 2 and 6 months would offer significant advantage. None of these issues have been addressed systematically so far.

Eligibility Criteria:
Inclusion Criteria:

* adult (\> 18 years old) diabetes mellitus patients
* diagnosed as having active pulmonary TB
* willing to join the study

Exclusion Criteria:

* under TB treatment more than 72 hours
* steroid-induced or gestational diabetes
Automated Phonocardiography Analysis in Adults

Background: Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) via artificial intelligence algorithms could be a useful tool to assist healthcare providers in identifying pathological heart murmurs and may avoid unnecessary referrals to medical specialists.

Objective: Assess the quality of the artificial intelligence (AI) algorithm that autonomously detects and classifies heart murmurs as either pathologic (AHA class I) or as no- or innocent (AHA class III).

Hypothesis: The algorithm used in this study is able to analyze and identify pathologic heart murmurs (AHA class I) in an adult population with valve defects with a similar sensitivity compared to medical specialist.

Methods: Each patient is auscultated and diagnosed independently by a medical specialist by means of standard auscultation. Auscultation findings are verified via gold-standard echocardiogram diagnosis. For each patient, a phonocardiogram (PCG) - a digital recording of the heart sounds - is acquired. The recordings are later analyzed using the AI algorithm. The algorithm results are compared to the findings of the medical professionals as well as to the echocardiogram findings.


Eligibility Criteria:
Inclusion Criteria:

* Adults with a heart defect verified by echocardiography
The Effect of Preoperative Information and Education in the Clinical Outcome of Total Hip Arthroplasty

Preoperative patient information and education is an essential aspect of modern surgical care, particularly for patients undergoing total hip arthroplasty (THA). This prospective, randomized trial aims to assess the effects of structured preoperative education and information on clinical outcomes in patients undergoing THA.

A total of 100 patients will be randomized into two groups: the intervention group (n = 50) receiving standardized preoperative information and education, and the control group (n = 50) receiving standard preoperative care without a formal educational component. Postoperative outcomes, including pain, functionality, mobility, length of hospital stay (LOS), health-related quality of life, anxiety and depression will be compared between the 2 groups.

Eligibility Criteria:
Exclusion criteria in the study will be patients:

* under 50 years old
* with reduced mental abilities
* with a presence of mental illness
* who have had previous hip surgery
Study of Biomechanical Parameters of Unloading Braces Used in the Treatment of Knee Osteoarthritis (BIOoSE)

Osteoarthritis is a chronic disease affecting millions of people worldwide, and knee is the second most affected site. Knee osteoarthritis is characterized by knee pain, loss of motion, disability, and muscle weakness, all factors contributing to gait alterations, and impacting greatly the patients quality of life. In the absence of curative treatment, pharmacological and non-pharmacological symptomatic treatments are prescribed to maintain this QoL, and therefore delay surgery to more appropriate window of opportunity later in life.

The aim of the study was to investigate the acute effects of three braces, using different unloading strategies, on gait kinematic and kinetic parameters, as well as pain in patients with medial knee ostoeoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* unilateral medial KOA classified II or III on the Kellgren-Lawrence scale
* varus misalignment with a joint space of at least two finger breadths
* pain level equal or higher than 30 mm on a 100 mm visual analog scale
* informed written consent

Exclusion Criteria:

* limited ability to walk
* normoaxial knee alignment
* intra-articular injection of a local treatment including corticosteroids in the 3 months or hyaluronic acid in the 6 months preceding its inclusion or analgesic or NSAID treatment with a wash-out period equal to 5 half-lives of the drug concerned
* undergoing physiotherapy
* cognitive disorders or behavioral disorders (opposition, agitation, dementia)
* arteriopathy of the lower limbs
* skin disorders contraindicating the wearing of rigid orthotics
* severe varicosity preventing the regular wearing of unloading brace
Feasibility of Laryngeal Mask Airway Gastro on Patients Undergoing Endoscopic Retrograde Cholangiopancreatography for Pancreas and Bile Duct Disorders

This trial determines the feasibility of Laryngeal Mask Airway Gastro (Laryngeal Mask Airway) when used on patients who are undergoing endoscopic retrograde cholangiopancreatography for pancreas and bile duct disorders. Laryngeal Mask Airway is a device that helps patients breathe while they are asleep during procedures.

PRIMARY OBJECTIVES:

I. To determine the successful completion of endoscopic retrograde cholangiopancreatography (ERCP) with the Laryngeal Mask Airway (LMA) Gastro.

SECONDARY OBJECTIVES:

I. To determine gastroenterologist satisfaction with the LMA Gastro.

II. To determine anesthesia provider satisfaction with the LMA Gastro.

III. To determine the rate of unsuccessful LMA Gastro placement.

IV. To determine the ability of LMA Gastro to provide adequate oxygenation and ventilation throughout the procedure.

V. To determine and describe the rate of adverse events.

OUTLINE:

Patients wear Laryngeal Mask Airway Gastro after receiving general anesthesia and falling asleep. Patients then undergo standard of care endoscopic retrograde cholangiopancreatography. Patients also complete a 5-minute interview following ERCP procedure.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing elective ERCP with general anesthesia

Exclusion Criteria:

* Patients with propofol allergy
* Patients at increased aspiration risk
* Patients with abnormal head/neck pathology preventing LMA Gastro placement
* Patients with surgical or radiation treatment to the head/neck making LMA Gastro placement difficult
* Esophagectomy patients
* Patients already intubated upon arrival to endoscopy suite
* Patients undergoing endoscopic ultrasound (EUS)
* Patients with body mass index (BMI) 35 kg/m\^2
* Non-English speaking patients
Financial Incentives to Increase Colorectal Cancer Screening in Priority Populations

The investigators propose to build on the success of the Systems of Support to Increase Colorectal Cancer trial (SOS, R01CA121125, Green) and focus on disparity groups who are less likely to be current for colorectal cancer (CRC) screening. We will test whether financial incentives increases screening uptake and decreases screening disparities. The investigators hypothesize that CRC screening rates will be higher in patients offered mailed fecal kits and financial incentives than those offered mailed fecal kits alone.

Study staff will send invitation letters and a questionnaire to 5,000 patients aged 50-75 not current for CRC screening, two-thirds who are identified in the electronic data as being from a non-White race, ethnicity, or who have Medicaid coverage. Those returning the survey and remaining eligible (estimated N = 1150) will be randomized to either (1) Mailed fecal kit only, or mailed fecal kit plus one of 2 types of financial incentives for completing testing: (2) a guaranteed Monetary incentive or (3) a probabilistic Lottery incentive.

Eligibility Criteria:
Inclusion Criteria:

* No evidence in electronic data of FIT screening in past year or a colonoscopy in the prior 9 years.
* Continuously enrolled in Group Health Cooperative (GHC) for at least one year.
* Patients who have Medicaid coverage or are non-white race or Hispanic any race.

Exclusion Criteria:

* Known high risk for CRC
* History of CRC
* History of inflammatory bowel disease
* Current anticoagulation therapy
* Organ failure
* Serious illness
* Debilitating disease
* Dementia
* Nursing home resident
Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)

A Phase 2, open-label, dose escalation study to evaluate the safety and efficacy of venetoclax in combination with carfilzomib-dexamethasone (Kd) in participants with relapsed or refractory MM and have received 1 to 3 prior lines of therapy.

Part 4 of this study is currently enrolling.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Collaborative Oncology Group (ECOG) performance score of less than or equal to 2.
* Documented relapsed or progressive Multiple Myeloma (MM) on or after any regimen or is refractory to the most recent line of therapy.
* Positive for translocation t(11;14) as determined by an analytically validated Fluorescent In Situ Hybridization (FISH) assay per central laboratory testing.
* Received prior treatment with at least 1 prior line of therapy for MM.
* Measurable disease on Screening per International Myeloma Working Group (IMWG) criteria.
* Meets absolute neutrophil count, platelet count, hemoglobin, liver and kidney function laboratory values within 2 weeks prior to first dose of study drug.

Exclusion Criteria:

* Has a pre-existing condition that is contraindicated including.

  * Non-secretory or oligo-secretory MM
  * Active plasma cell leukemia.
  * Waldenström's macroglobulinemia.
  * Primary amyloidosis.
  * POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
  * Active hepatitis B or C infection based on screening blood testing.
  * Known active Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
  * Significant cardiovascular disease.
  * Major surgery within 4 weeks prior to first dose.
  * Acute infections requiring antibiotic, antifungal or antiviral therapy within14 days prior to first dose.
  * Peripheral neuropathy ≥ Grade 3 or ≥ Grade 2 with pain within 2 weeks prior to first dose.
  * Uncontrolled diabetes or uncontrolled hypertension within 14 days prior to first dose.
  * Any other medical condition that, in the opinion of the Investigator, would adversely affect the participant's participation in the study.
* History of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry Other protocol defined inclusion/exclusion criteria could apply
Alternative Care to the Accompaniment Called "Place of Respite" in the Resolution of the Psychotic Crises of Homeless People With Severe Mental Pathology

Document the effectiveness of the "Respite Site" program in relation to the current health system. Document in particular the number and type of constraints, lengths of hospitalization and mode of exit, as well as the exit destination of psychotic homeless people.

Between 2012 and 2015, the practice of "stress-related care" related to crisis situations increased by 15%, with about 90,000 people under duress making France one of the European countries where practice most under stress. Being homeless, from a visible ethnic minority, combined with the lack of alternatives in the territory are well-documented risk factors for being hospitalized under duress. A review of the 2015 literature has shown that out-of-hospital crisis sites achieve results equivalent to those of conventional hospitalization in terms of reduced symptomatology and would have better outcomes in terms of increase in remission and recovery times of professional activity and social inclusion, with greater efficiency. In Marseille, an experimental device has shown its capacity to propose an alternative to hospitalization, for this type of population.Running the lessons of this experiment and inspired by the experimentation Parachute, a new device experimental, called "Place of respite", This place proposes a model of resolution of the psychotic crisis where the person decides the type of care that she wish to receive. It is a device that is therefore an alternative to conventional psychiatric care under duress. The investigators formulate the hypothesis that alternative support to the resolution of the crisis by using the skills of people with disorders severe psychiatric conditions in the experimental "Respite site" decreases in the short term the number of hospitalizations and their duration, as well as the experience of the constraint in the course of care of these people, compared to the subjects who did not benefit from this device and could represent a model of crisis management / psychiatric emergency efficient with regard to the current offer.

Eligibility Criteria:
Inclusion Criteria:

Over 18 years old Diagnosed with schizophrenia, bipolar I disorder, or schizoaffective disorder according to the DSMIV classification Homeless "ETHOS 1 or 2" (FEANTSA classification) In a crisis situation: psychiatric crisis (PANSS increase of more than 20%), social crisis (significant alteration of social relations) Affiliated to a social protection scheme Accepting to participate in the study An HCAT score greater than or equal to 3

Exclusion Criteria:

Under 18 years old Participant in another study simultaneously in accordance with Article L112112 of the public health code Refusing to participate in the study, or whose legal representative refuses to participate in the study in the case of a person under guardianship or curatorship A score on the HCAT scale (decision-making competence) strictly less than 3