cyrilzakka/clinical-trials huggingface dataset:
Stress Biomarkers Leading to Professional Burnout Among People Involved in a Mobile Intensive Care Unit During the COVID-19 Pandemic

This study is aiming at investigating whether professional burnout in people involved in the mobile intensive care unit (in French: Element Mobile de Réanimation, EMR) in Mulhouse (France) can be predicted upstream by a low mindfulness level (as a protective factor) or by a dysregulation of stress pathways with a high level of perceived stress towards an emotional event (psychological index of allostatic load), i.e. an early and silent dysfunctional physiological response (measured by the electrophysiological and biological measurements of allostasis load and parasympathetic brake).

It is part of a global approach aiming at identifying levers to prevent the allostatic load of occupational stress related to large-scale health crises.


Eligibility Criteria:
Inclusion Criteria:

* Volunteer staff member of the Mulhouse mobile intensive care unit (in French: Elément mobile de réanimation, EMR), including military reservists.

Exclusion Criteria:

* Pregnant or breastfeeding woman,
* Person deprived of liberty by a judicial or administrative decision,
* Person subject to a legal protection measure or unable of giving consent
* Intercurrent pathology with inability to work
* History of psychiatric disorder or cardiac pathology
Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating

The purpose of this combination retrospective and prospective post market study is to examine the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE® plates to treat single and two-level degenerative disc disease between L2 and S1, with a focus on fusion rates and patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have degenerative disc disease (DDD) of the lumbar spine between L2 and S1
* Subjects may have up to a Grade 1 spondylolisthesis at the involved level(s)
* Subject must have the ROI-A® device at one level or at two contiguous levels between L2 and S1 only
* Subject should have had a minimum of 6 months non-surgical treatment prior to receiving the ROI-A® device
* Subject may have had NO MORE THAN two previous non-fusion surgeries to the lumbar spine at the same levels as the ROI-A®
* Subject must be at least 21 years of age at the time of surgery
* Subject must be willing to signed an informed consent document and return for a 12 month visit

Exclusion Criteria:

* Subject had more than Grade 1 spondylolisthesis at the operated level
* Subject is a prisoner.
* Subject was pregnant at the time of surgery.
* Subject had an active infection or sepsis at the time of surgery.
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease

The primary objectives of this study are:

* To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD);
* To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.


Eligibility Criteria:
Inclusion Criteria:

- Meet criteria for CAD and/or PAD

Subjects with CAD must also meet at least one of the following criteria:

* Age ≥65, or
* Age \<65 and documented atherosclerosis or revascularization involving at least 2 vascular beds, or at least 2 additional risk factors

Exclusion Criteria:

* Stroke within 1 month or any history of hemorrhagic or lacunar stroke
* Severe heart failure with known ejection fraction \<30% or New York Heart Association (NYHA) class III or IV symptoms
* Estimated glomerular filtration rate (eGFR)\<15 mL/min
* Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy
Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients

Postoperative delirium (POD) is a common surgical complication. The incidence is 10% to 22% in neurological procedures, and advanced age is a risk factor for neurological procedures. Many studies have shown that dexmedetomidine(DEX) may reduce the incidence of delirium in non-cardiac surgery patients and elderly patients. However, there are few studies focus on the effect of DEX on POD in elderly patients undergoing neurosurgery. The purpose of this study was to investigate the effect of DEX on POD in in elderly patients undergoing craniotomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing selective craniotomy.
* Age ≥65 years.
* Obtain written informed consent.

Exclusion Criteria:

* Operation time less than 2 hours.
* Refusal to provide written informed consent.
* Cognitive impairment before surgery(mini-mental state examination, MMSE ≤ 26 or Montreal Cognitive Assessment, MoCA≤22).
* Allergic to the study drug.
* Body mass index ≤18 or ≥ 30 kg/m2.
* History of psychotropic drugs, anticholinergic drugs, antihistamine drug and dopaminergic drugs.
* History of traumatic brain injury or neurosurgery.
* Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
* Severe liver dysfunction (Child-Pugh grade C) or renal failure (requiring kidney replacement therapy).
* The functional neurosurgery.
Anemia in Orthopedic Surgery - Determination of Hb

Anemia prevalence in orthopedic surgery is up to 30 %. Identifying those patients prior to surgery and treating them would be ideal. Different ways of determining hemoglobin Levels are available. In this study classical laboratory determination, determination with HemoCue® and Rad-67™ will be performed to compare precision of those three methods as well as their correlation.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Scheduled for elective orthopedic surgery
* Written informed consent.

Exclusion Criteria:

• Not able to speak the german language
Promoting Palliative Care for People With Heart Failure

This project will develop and test a novel clinical decision support tool (CDS) that encourages timely referral to palliative care for people hospitalized with heart failure. This intervention will incorporate an existing, validated 1-year mortality risk model into a CDS to deliver prognostic information and evidence-based decision support at the point of care. Thus, this research may lead to improved care-concordant and goal-directed care for people with heart failure.

Healthcare providers will encounter the tool during the routine care of their hospitalized patients. Providers randomized to the intervention arm will receive training on the use of the tool and complete one post-trial survey. Providers randomized to the intervention arm will also have the opportunity to participate in 1 post-trial interview. Level 2 providers will participate in one interview.

Eligibility Criteria:
Inclusion Criteria:

Healthcare providers must meet the following criteria:

* Are an attending physician, fellow, or resident, advanced practice nurse, or physician associate
* Has ordering privileges
* Are members of one of the hospitals' admitting teams (e.g., hospitalist service, cardiology service)
* Anticipate employment at one of the two study sites for the 15-month trial period.

Or

* Palliative care team member
* Hospital administrator/quality and safety personnel

Patients of providers enrolled in the study must meet the following criteria for heart failure during hospitalization:

* N-terminal pro-B-type natriuretic peptide values of \>500 pg/ml
* Not pregnant at the time of admission.
* Received intravenous diuretics within 24 hours of admission.

Exclusion Criteria:

-
A Study Evaluating a Proprietary Amino Acid Mixture (Enterade®)- for Maintaining Bowel Regularity in Patients With GI Toxicity From Any Combination of Therapy Including Tyrosine Kinase Inhibitors (TKI)

This is an open label, randomized investigation of a proprietary blend of amino acids, called Enterade®, and its effect on irregularity (diarrhea) caused by radiation therapy and/or chemotherapy including TKI\*. Subjects will be randomized to receive Enterade® or continue standard of care. Two patients will be enrolled on the treatment arm for each patient on the control arm.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with any combination of therapies including radiation therapy alone, chemotherapy alone, TKI alone, or any combination are eligible.
2. This includes patients with therapies including Xeloda (capecitabine), Camptosar (irinotecan) or 5-FU (fluorouracil) with cancer.
3. Patients who have been diagnosed with a CID CTCAE toxicity of grade 3 or higher
4. Patients must be at least 18 years of age.
5. ECOG performance status 0-2.
6. Patients must have diarrhea symptoms, judged secondary to the systemic therapy, combined systemic therapy, and/or radiation, and must be requiring loperamide or similar (Imodium®) for symptom management. For the purposes of this study, diarrhea will be defined as three or more loose or liquid stools per day or loose watery stool (greater volume of stool) that occur more frequently than usual and lasting for more than three days.

Exclusion Criteria:

1. ECOG performance status 3 or greater.
2. Pregnant and/or breast-feeding women
3. Pre-menopausal subjects as well as subjects with ovarian radiation or concomitant treatment with an LH-RH agonist/antagonist must have a negative pregnancy test and agree to use an adequate method of contraception as recommended by their treating physicians
4. Post-menopausal status is defined either by:

   1. age ≥55 years and one year or more of amenorrhea,
   2. age \<55 years and one year or more of amenorrhea with an estradiol assay \<20 pg/mL
   3. bilateral oophorectomy
   4. CID CTCAE grade 1 or 2 (not requiring Loperamide or similar)
In Vitro Fertilization Outcomes in Metabolic Syndrome

The purpose of this study is to examine the effect of metabolic syndrome in over-weight women on IVF treatment outcomes.

This porpuse of the study is to examine the physiology of CRP during the IVF cycle in and to evaluated the effect of CRP in patient with and without metabolic syndrome on IVF outcomes

Eligibility Criteria:
Inclusion Criteria:

* women undergoing ivf treatment

Exclusion Criteria:

* inflammatory disease
* acute conditions
ME-344 and Bevacizumab in Previously Treated Metastatic Colorectal Cancer

This is a Phase 1b open-label, multiple dose/schedule sequential study to determine the safety and efficacy of the oxidative phosphorylation (OxPhos) pathway inhibitor ME-344 in combination with bevacizumab in subjects with recurrent mCRC.

This is a Phase 1b open-label, multiple dose/schedule sequential study to determine the safety and efficacy of the oxidative phosphorylation (OxPhos) pathway inhibitor ME-344 in combination with bevacizumab in subjects with recurrent mCRC.

This study will enroll subjects with metastatic CRC, including but not limited to subjects with RAS wild-type or mutant tumors, MSI-H/pMMR, and BRAF V600E, who have progressed or demonstrated intolerability to standard approved therapies which include fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, cetuximab/panitumumab, PD-1 inhibitors, or BRAF inhibitors (if clinically indicated), and/or other checkpoint inhibitors. Approximately 40 subjects will be enrolled in the study, in 2 cohorts of 20 subjects each.

Subjects will continue treatment with ME-344 and bevacizumab until radiological progressive disease, unacceptable AEs, withdrawal of consent, start of new anticancer therapy, or death.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Histological or cytological documentation of adenocarcinoma of the colon or rectum that is metastatic (all other histological types are excluded)
* Subjects who progressed or demonstrated intolerability to prior standard approved therapies which include fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapies, cetuximab/panitumumab (if clinically indicated e.g., RAS wild-type tumors) PD-1 or BRAF inhibitors (if clinically indicated), and/or other checkpoint inhibitors in the metastatic setting.
* Previous treatment with any investigational drug or anticancer treatment must be completed \>28 days or 5 half-lives, whichever is longer, before the first dose of study treatment.
* Adequate bone marrow, liver, and renal function

Exclusion Criteria:

* Untreated brain metastases, spinal cord compression, or primary brain tumor
* Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor
* Evidence of uncontrolled or unstable cardiovascular disease, myocardial infarction (within 6 months), unstable angina pectoris, congestive heart failure, serious arrhythmias requiring drug therapy
* History of CNS disease
* Bevacizumab or aflibercept therapy ≤ 3 weeks prior to starting study treatment
* Peripheral neuropathy Grade ≥ 2
* Uncontrolled hypertension or diabetes mellitus, active peptic ulcers, unhealed wounds, clinically significant disease or systemic infections
* Known seropositive for, or active infection with hepatitis B or C virus
* Symptomatic or uncontrolled infection with human T-cell leukemia virus
* Venous thromboembolism (unless appropriately treated and stable on anticoagulant for at least 2 weeks).
Effect of Hamstring Stretching on Cervical Flexor Muscle Endurance

The superficial posterior line is one of the eight main fascial lines defined on the body. One of the important muscle groups on this line is the hamstring muscle group. Studies have shown that various stretching methods applied to the hamstring muscle group affect the cervical region both in terms of range of motion and posture. As a result of this study, it was shown that deep neck flexor endurance increased in women who applied the PNF hold-relax method.

The superficial posterior line is one of the eight main fascial lines defined on the body. One of the important muscle groups on this line is the hamstring muscle group. Studies have shown that various stretching methods applied to the hamstring muscle group affect the cervical region both in terms of range of motion and posture. Our aim in our study is to examine the effect of the proprioceptive neuromuscular stretching (PNF) method applied to the hamstring muscle group on the endura of the deep neck flexors based on these data.

Eligibility Criteria:
Inclusion Criteria:

* being female
* being healthy in musculoskeletal conditions

Exclusion Criteria:

* being hypermobile
Breast Milk and Infant Growth Among Lean, Overweight and Diabetic Mothers

Childhood obesity is a critical global public health concern. Breastfeeding is the ideal choice for infant nutrition. However, rapid and excess weight gain during infancy predicts later, even among breastfed infants. This risk is higher if mothers are obese and/or diabetic. Composition of bioactive components of breast milk may differ based between mothers who are normal weight (NW), overweight, or who have diabetes. Obesity and Type 2 Diabetes are associated with overall increases in inflammation and oxidative stress, but how breast milk composition is affected remains unknown. The investigators overarching goal is to determine how maternal obesity and Type 2 Diabetes impacts human breast milk composition and how differences in composition may impact infant growth and fat development. The investigators are undertaking a study that follows 20 Normal Weight, 20 Obese, 20 Gestational Diabetic, and 20 Type 2 Diabetic mothers and their infants over the first 4 months of life. The investigators will track infant weight and fat gain and monitor maternal glucose control. The investigators will also collect breast milk samples over the first 4 months and measure concentrations of growth and appetite hormones, cytokines, markers of oxidative stress and nutrient composition in milk. The investigators predict that concentrations of growth-regulatory hormones (insulin and leptin) in addition to the inflammatory cytokines and markers of oxidative stress will be lowest in breast milk from NW mothers, higher in breast milk from obese and gestational diabetic mothers, and highest in Type 2 Diabetic mothers' breast milk. The investigators expect these differences will be most pronounced in the first 2 weeks after birth. The investigators also predict that breast milk concentrations of these biomarkers will be associated with infant fat gain. What the investigators find will help understand how early infant nutrition and growth may affect that child's later risk of obesity.


Eligibility Criteria:
Inclusion Criteria:

* Between 28-40 weeks gestation
* Plan to Exclusively Breastfeed for at least 5 months
* Between 20 - 35 years old
* Carrying a singleton pregnancy
* Parity less than or equal to 5
* Pre-pregnancy BMI between 18.5 and 39.9

Exclusion Criteria:

* No known infant anomalies or birth defects
* Maternal Type 1 Diabetes
* Maternal major medical condition (ie: Kidney Disease or Pre-eclampsia)
* Delivery of the infant before 35 weeks gestation
* Smoking During pregnancy
Cost/Effectiveness Analysis of the Respiratory Poligraphy at Home

The abbreviated diagnostic sleep studies (RP), made at home and transferred telematically to the sleep laboratory, are useful for the diagnosis of sleep apnea and due to a lower cost, it could be an alternative to conventional polysomnography. Objectives: 1) Usefulness of domiciliary study evaluated by percentage of patients diagnosed of SAHS compared with PSG and agreement in the therapeutic decision. 2) Direct costs of patients included in the study. Design: controlled, randomized, crossed and blind (320 patients) comparing PR made at home with PSG, in patients suspicious of SAHS. The equipment transfer will be made by a transport agency from home to home in order to be universal the access to this diagnostic model. The file transmission with the raw data of the study will be made telematically by GPRS. If the aims of the study reach an end there will be a considerable change in the clinical practice making possible the international acceptation of domiciliary PR as diagnosis of SAHS and adapting the diagnosis of this syndrome to the new technologies of communication. The universalization of domiciliary PR would make possible that the diagnosis of SAHS could be done in any patient and in any country with GPRS technology and a transport agency, that is to say in all developed countries. As sleep apneas affect 5-7 million persons in Spain and there is association between sleep apneas and cardiovascular risk, in the immediate future we must evaluate this disease as we do today with the cholesterol determination. If our results are as predicted, the primary care physician could start and in a lot of cases finish the SAHS diagnostic process. This would simplify remarkably the diagnosis of SAHS and would alleviate a lot the process cost all over the world.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 70 years.
2. Without clinical suspicion referred to any other sleep pathology susceptible of presenting daytime sleepiness.
3. Living 20 Km or more far from the hospital participating in the study.

Exclusion Criteria:

1. Psychophysical incapacity to answer questionnaires.
2. Patients who do not get pass the proof of placing the PR (see below).
3. Patients who present restrictive chronic disease previously diagnosed (neoplasy, any origin chronic pain, renal failure, severe chronic obstructive pulmonary disease and any other limited chronic disease)
4. Structural cardiopaty or coronary documented non controlled by means of medical treatment .
5. Toxicomanies. Alcoholism (more than 80 gr/day in men and 60 gr/day in women.
6. Informed consent not obtained.
A Prospective Study of Medical Therapy Against Cryoballoon Ablation in Symptomatic Recent Onset Persistent AF

Prospective trial comparing the efficacy and safety of CryoBalloonAblation (CBA) to standardized medication for treatment of early onset persistent atrial fibrillation (AF) without structural heart disease. The value of CBA in these patients has never been studied; the endpoints for persistent patients are much easier than for paroxysmal patients. Reduction in left atrial (LA) size will be compared versus patients on drug therapy and versus failing patients.

The total AF history should be shorter than 24 months. Symptomatic patients can be included if they have had within the last year at least 2 episodes of documented AF, lasting minimal 30 sec. One episode in the entire history should have lasted more than 48 h, requiring electrical or pharmacological cardioversion or stopped spontaneously after more than 7 days.

All patients eligible for the study will sign informed consent, have an echocardiogram prior to inclusion to exclude severe left ventricular dysfunction, to rule out significant valve abnormalities, left ventricular hypertrophy and to assess the LA volume and diameter.

Prior to randomization, and after inclusion it is suggested to the local investigators to perform an MRI-scan or CT scan of the LA and pulmonary veins (in both branches of the study ) in eligible patients to assess the anatomy and the left atrial volume. The results should not influence the strategy of treatment.

Eligibility Criteria:
Inclusion Criteria:

* \> 21 years and legally capable
* First documentation or history of symptomatic AF more than 30 sec within the last 2 years
* Twice AF within the last year
* One episode cardioverted after more than 48 hours or spontaneously terminated after more than 7 days
* Eligible for at least one first step drug therapy (sotalol, propafenone, or flecainide) and for amiodarone
* Left ventricular ejection fraction estimated \> 45%
* LA diameter \< 50 mm (parasternal short axis) and LA volume less than 100 ml (apical view, Area Length method;)
* CHADS2 ≤ 2
* Failed AAD strategy, or untreated with AAD
* No use of Amiodarone in the previous 3 months (except IV or oral for 7 days)
* Informed consent

Exclusion Criteria:

* Age \> 75 yrs
* CHF
* Ischemic heart disease as known in the history
* (Severe) Left ventricular hypertrophy as shown on echo (IVSd or PWd \> 14 mm)
* Hyperthyroidism
* Congenital heart disease
* Hypertrophic Cardiomyopathy, Arrhythmogenic Right ventricular Cardiomyopathy, channelopathies
* Contra-indications to AAD
* Long QT syndrome
* Received already adequately dosed all level 1 drugs (sotalol, propafenone, and flecainide)
* Pure (typical) atrial flutter as documented on one occasion
ER2 Frailty Levels and Incident Adverse Health Events in Older Community Dwellers

Older adults' health and functional status are heterogeneous because of the various cumulative effects of chronic diseases and physiologic decline, contributing to a vicious cycle of increased frailty 1-4. Thanks to advances in medicine and hygiene, a growing number of older adults spend more years with a greater range of chronic diseases causing disability but not mortality 5. Health systems need to face this new challenge 4,5. Quantification of frailty and its association with the occurrence of incident adverse health events (i.e., functional decline, unplanned hospitalizations) is crucial to understand how health systems may efficiently respond to this situation 6. This study aims to examine the association of the ER2 tool score and its stratification in three levels for incident adverse health events in older community dwellers and to compare this association with three validity frailty indexes which are the Cardiovascular Health Study (CHS) frailty index, Study of Osteoporotic Fracture (SOF) index and Rockwood frailty index.


Eligibility Criteria:
Inclusion Criteria:

* All enrolled participants of NuAge Study who agreed to be part of the NuAge Database and Biobank for future research purposes

Exclusion Criteria:

* Missing data
* Participants' refusal to use their data for a purpose not identified during their recruitment.