Kornimate/medical-research-clean huggingface dataset:
chronic neck pain and kinesiophobia

Conditions: Chronic Neck Pain

Summary: in this study, the primary aim was to examine the relationship between kinesiophobia and clinical outcomes in individuals with chronic neck pain. the secondary aim was to compare the level of neck disability, pain, endurance, functionality, muscle and grip strength, and quality of life in individuals with chronic neck pain who had and did not have kinesiophobia; and to determine the determinants of kinesiophobia in patients with chronic neck pain.


Eligibility criteria:
inclusion criteria: * neck pain complaints that have been ongoing for at least 3 months * between the ages of 18-65 * complaints of numbness and tingling * volunteer who can cooperate during communication exclusion criteria: * history of spinal trauma or surgery * neurological, rheumatological, systemic or musculoskeletal problems that affect movement * serious comorbidities (such as advanced renal failure, previous history of cva, malignancy) * muscle weakness

Keywords: chronic neck pain kinesiophobia quality of life functionality
filtration of subarachnoid hemorrhage via spinal catheter extension

Conditions: Subarachnoid Hemorrhage

Summary: the objective of this study is to further demonstrate safety and characterize effectiveness of the neurapheresis™ system (extracorporeal system and catheter) to remove red blood cells (rbcs) and lysed blood by-products from hemorrhagic cerebrospinal fluid (csf) following aneurysmal subarachnoid hemorrhage (asah).

the pillar-xt study is designed to further confirm safety and characterize efficacy of neurapheresis therapy. the study works in tandem with the current soc treatments for sah and does not detract from the established care pathways, or deny enrolled subjects proven therapies. the pillar-xt study utilizes the established skill sets of chosen investigators who are already trained in the treatment and care of sah patients and insertion/management of lumbar drains.

Eligibility criteria:
inclusion criteria: * modified fisher grade 2, 3 or 4 * hunt \& hess i-iv * first aneurysmal sah * patient is ≤ 48 hours post bleeding event * world federation of neurosurgeons (wfns) grades i-iv exclusion criteria: * pregnancy * patients with a sah due to mycotic aneurysm or av malformation * patients who present with an acute mi or unstable angina * imaging demonstrates supratentorial mass lesions \> or = 15 cc * imaging demonstrates \> or = 2 mm of mid-line-shift associated with infarction and or edema * effacement of the basilar cisterns * vasospasm on admission as defined by angiographic evidence * patients with a coagulopathy that cannot be reversed * thrombocytopenia def. platelet count \< 100,000 * patients on low molecular weight heparin such as lovenox * non-communicating obstructive hydrocephalus * existing hardware that prevents accurate ct imaging * pre-existing lumbar drain * local skin infections or eruptions over the puncture site * signs of cns systemic infection, sepsis or pneumonia

Keywords: aneurysmal
trauma exposure, emotion regulation and eating pathology in obese patients

Conditions: Obesity

Summary: the purpose of this study is to investigate the associations between lifetime exposure to traumatic events, emotion regulation strategies, and eating pathology of patients with obesity.


Eligibility criteria:
inclusion criteria: * adults * obese (bmi \>= 30) * recruited from the nutrition service of hôpital européen georges-pompidou * informed consent provided exclusion criteria: * ptsd symptoms (score \> 33 ; ptsd checklist-5) * bariatric surgery patients * difficulties to understand french language * patients under social protection

Keywords: trauma exposure psychological distress emotion regulation mindfulness eating pathology
age-dependent changes in the responsiveness of hypothalamic pituitary gonadal axis in men

Conditions: Sterility, Reproductive

Summary: the present study was designed to assess the responsiveness of the hypothalamic pituitary gonadal axis to kisspeptin administration with increasing age in men.

little is known about the involvement of kisspeptin signalling in the causation of senescence-basal modulation of the gnrh-lh unit in any model and particularly in advance age men. the present study was therefore designed to assess the response of hypothalamic pituitary gonadal axis to kisspeptin administration with increasing age in healthy men. sequential blood samples (2 ml) were obtained for 30 minutes pre and 120 minutes post-kisspeptin injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). kisspeptin-10 was administered (1 µg/kg bw) as an intravenous bolus, immediately after collecting 0 min sample to assess the response of gnrh neurons to kisspeptin-10 with increasing age in men by determining plasma levels of lh and testosterone.

Eligibility criteria:
inclusion criteria: • age exclusion criteria: * hepatic and renal complications * epilepsy * pneumonia * asthma * orchitis * hernia * cryptorchidism * cardiovascular diseases * reproductive disorders * mental retardation

Keywords: aging
a phase 3 study of tenapanor to treat hyperphosphatemia in esrd patients on dialysis

Conditions: Hyperphosphatemia

Summary: this phase 3, 26-week, open label study with a 12-week, placebo-controlled, randomized withdrawal period followed by an open label long term safety extension will evaluate the safety and efficacy of tenapanor to treat hyperphosphatemia in end-stage renal disease (esrd) on hemodialysis and peritoneal dialysis.

the study consists of a screening visit, a phosphate binder-free washout period of up to 4 weeks, a 26-week treatment period, an up to 12-week placebo-controlled, randomized withdrawal period, during which patients are randomized 1:1 to either remain on their tenapanor treatment or placebo, followed by an open label safety extension period for a total treatment period of up to 52 weeks. an active control group, for safety analysis only, will receive sevelamer carbonate, open label, for the entire 52-week study period depending on increase in serum phosphate (s-p) levels, subjects can be randomized 2 or 3 weeks after being taken off their phosphate lowering medication. subjects who qualify to enroll in the study will be randomized 3:1 to either receive tenapanor at a dose of 30 mg bid or sevelamer carbonate.

Eligibility criteria:
inclusion criteria: * females must be non-pregnant, non-lactating, and either be post-menopausal for at least 12 months, have documentation of irreversible surgical sterilization, or confirm the use of one of the acceptable contraceptive methods * males must agree to avoid fathering a child and agree to use an appropriate method of contraception * chronic maintenance hemodialysis 3x a week for at least 3 months * chronic maintenance peritoneal dialysis for a minimum of 6 months * kt/v ≥ 1.2 at most recent measurement prior to screening * prescribed and taking at least 3 doses of phosphate binder per day * serum phosphorus levels should be between 4.0 and 8.0 mg/dl at screening * unchanged dose of vitamin d or calcimimetics for the last 4 weeks prior to screening * for enrollment in the study after at least 2 weeks of wash-out, subjects must have serum phosphorus levels of at least 6.0 mg/dl but not more than 10.0 mg/dl and have had an increase of at least 1.5 mg/dl versus pre-wash out value after 2 or 3 weeks wash-out of phosphate binders exclusion criteria: * severe hyperphosphatemia defined as serum phosphorus greater than 10.0 mg/dl on phosphate-binders at any time point during clinical routine monitoring for the 3 preceding months before screening visit * serum/plasma parathyroid hormone \>1200 pg/ml * clinical signs of hypovolemia at enrollment * history of ibd or ibs-d * scheduled for living donor kidney transplant, change to peritoneal dialysis, home hd or plans to relocate to another center during the study period * positive serology with evidence of significant hepatic impairment or wbc elevation according to the investigator * life expectancy \<6 months * previous exposure to tenapanor
the treatment of lapatinib in combination with sorafenib in patients with advanced refractory solid tumors

Conditions: Solid Tumors

Summary: over the last decade, improvements in the investigators' understanding of the molecular basis of cancer have led to the clinical development of protein kinase inhibitors, which target pivotal molecules involved in intracellular signaling pathways implicated in tumorigenesis and tumor progression. lapatinib is an oral selective and reversible inhibitor of the tyrosine kinase domain of epidermal growth factor receptor (egfr) and human epidermal growth factor receptor type 2 (her-2), which are both frequently altered in human malignant tumors. sorafenib is an oral multi-kinase inhibitor with a dual-action that prevents tumor cell proliferation and angiogenesis. the investigators suggest that through a complete blockade of erbb signaling network it may be possible to ''sensitize'' tumor cells to antiangiogenic therapy, by lowering the tumor cell survival threshold, while through inhibition of vascular endothelial growth factor (vegf) pathway to circumvent the problem of acquired resistance to egfr inhibitors. based on this theoretical rationale we decide to test the combination of lapatinib and sorafenib. this phase i trial will be undertaken to assess the maximum dose tolerated (mtd), safety/tolerability, pharmacokinetics and antitumor efficacy of this combination in patients with advanced, recurrent or metastatic solid cancers refractory to available standard treatment.

this is a dual-agent, prospective, open-label, multi-centric, phase i trial of combination of lapatinib and sorafenib in patients with locally advanced, recurrent or metastatic solid tumors. this trial will be conducted to determine the maximum tolerated dose (mtd), safety/tolerability, pharmacokinetics, and antitumor activity of these two agents given together on a continuous schedule, in patients with advanced solid tumors. our ambition is to recommend a safe dose regimen of the combination for subsequent larger phase ii studies, coinciding with the maximum tolerated dose (mtd). the maximum tolerated dose (mtd), will be defined as the highest dosage cohort at which no more than one of six patients will be experienced a dlt in the first treatment cycle. eligible patients will be enrolled and treated according to the schema, using a 3+3 design (fibonacci method modified);

Eligibility criteria:
inclusion criteria: * patients with locally advanced, recurrent or metastatic histologically confirmed malignancy refractory to available standard treatment exclusion criteria: * prior treatment with lapatinib, sorafenib or any agents targeting egfr (other than trastuzumab), raf, vegf, or vegfr
novel cardiac pacing to initiate cardiac remodeling in heart failure

Conditions: Cardiomyopathies; Heart Rate; Conditioning

Summary: this project utilizes a novel cardiac pacing approach hypothesized to initiate beneficial cardiac conditioning and remodeling over a period of time.

the project studies subjects with non-ischemic cardiomyopathy who have a pacing device already implanted. subjects randomized to the pacing intervention versus a sham intervention will be compared for various symptomatic, functional and other outcomes. each subject will undergo baseline quality of life/symptom questionnaires and clinical testing for cardiac functional/structural effects and exercise tolerance, then the intervention vs. sham (subjects blinded to their category), followed by repeat questionnaires and clinical testing. medical record review will be undertaken to establish demographic variables, baseline and follow up testing results.

Eligibility criteria:
inclusion criteria: * non-ischemic cardiomyopathy * ejection fraction \</= 35% despite at least 3 months stable standard medical management * new york heart association class ii-iii symptoms * dual chamber implantable cardioverter defibrillator in place or biventricular icd in place (over 3 months old) * normal atrioventricular conduction or biventricular icd * qrs \< 120 msec (inherent conduction or paced with biv icd) exclusion criteria: * age \< 18 years * inability to ambulate safely * congenital or primary valve disease * left ventricular thrombus * severe peripheral arterial disease * admission for life-threatening condition (eg heart failure, stroke) in the past 3 months * major surgery in the past 3 months or anticipated during the period of the trial * paced or intrinsic qrs \>120 msec * life expectancy \< 1 year * hemodialysis * hematocrit \< 30% * severe chronic lung disease * pregnancy * icd battery longevity \< 1 year * unsuppressed atrial arrhythmias * already participating in an exercise programusion criteria
a study in older subjects to evaluate the safety and ability of andexanet alfa to reverse the anticoagulation effect of apixaban

Conditions: Bleeding

Summary: the purpose of this stuy is to evaluate the ability of andexanet alfa to reverse the anticoagulation effect of apixaban.


Eligibility criteria:
inclusion criteria: * reasonably healthy men and women aged 50 to 75 exclusion criteria: * history of abnormal bleeding, active bleeding or risk factors for bleeding * history of thrombosis or risk factors for thrombosis * history of adult asthma or use of inhaled medications

Keywords: andexanet alpha anticoagulation antidote apixaban anti-fxa inhibitor prt4445 eliquis reversal agent
remote magnetic navigation-guided ablation versus cryoablation for persistent atrial fibrillation (recreation study)

Conditions: Persistent Atrial Fibrillation

Summary: compare the safety and efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.

1. compare the efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation. 2. compare the safety of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation. 3. compare the procedural parameters of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation. 4. compare the effects of amiodarone on recurrence after these two different ablation procedures.

Eligibility criteria:
inclusion criteria: 1. persistent atrial fibrillation (\>7d, \< 5years) 2. age 18-75 years 3. patient is mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol exclusion criteria: 1. any previous left atrial ablation or surgery 2. any cardiac surgery or percutaneous coronary intervention within 3 months prior to enrollment 3. stroke or transient ischemic attack within 6 months prior to enrollment 4. myocardial infarction within 3 months prior to enrollment 5. anteroposterior left atrial diameter \> 55 mm

Keywords: persistent atrial fibrillation remote magnetic navigation cryoablation
hiit improves survival of heart failure patients

Conditions: Heart Failure; Cardiac Rehabilitation; Cardiac Remodeling, Ventricular

Summary: background global burdens of heart failure (hf) are increasing in modern societies. high-intensity interval training (hiit) increases peak oxygen consumption (vo2peak) in hf patients, which was hypothesized to improve the survival of hf patients. objectives the cohort study aimed to highlight the effect of hiit on long-term survivals of hf patients. methods 329 hf patients, enrolled between 2009 and 2016, received multidisciplinary disease management program (mdp). they had cardiopulmonary exercise test for peak exercise capacity (vo2peak), echocardiographic examination for left ventricular ejection fraction (lvef), lv end-diastolic diameter (lvedd), and lv end-systolic diameter (lvesd), b-type natriuretic peptide (bnp), and quality of life questionnaire. hf patients with lvef≤ 40% (hfref) and hf patients with lvef\> 40% (hfpef) underwent≥ 36 times of hiit. hfref and hfpef patients were classified as the mdp group. generalized estimating equation (gee) was used to estimate the interaction between time and vo2peak, lvef, lvedd, lvesd, and bnp during the follow-up. survival analysis was conducted to assess effects of hiit on the long-term survival of hf during at end of the study.


Eligibility criteria:
inclusion criteria: from january 1st, 2009 to december 31st, 2016, hf patients, defined according to the european society of cardiology, with stable clinical status greater than 4 weeks after optimal treatment were enrolled in the study. exclusion criteria: those, who were ≥ 80 years and \< 20 years, unable to perform exercise caused by other non-cardiac disease, pregnant, future cardiac transplantation within 6 months, uncompensated hf patients, pacemaker patients, and renal patients with estimated glomerular filtration rate \< 30 ml/min/1.73m2, were not candidates in the study. patients had absolute contraindications for cardiopulmonary exercise test (cpet) and aerobic activities, suggested by the american college of sports medicine (acsm), were also excluded in the study.
adherence rate of monthly bubble package among patients prescribed adjuvant endocrine therapy in breast cancer survivors

Conditions: Breast Cancer

Summary: this study aims to establish the feasibility of using a monthly bubble package to improve compliance rates among women prescribed adjuvant endocrine therapy.

this study uses bubble packaging to provide a cost effective way to improve compliance and help direct further interventions to ensure adherence in women on anti-estrogen therapy for breast cancer.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * estrogen receptor positive (\> 1% estrogen expression) by immunohistochemistry * invasive breast cancer (stage i, ii, iii) or dcis considered for adjuvant endocrine therapy exclusion criteria: * patients with metastatic disease (stage iv) * patients less than 18 years of age * prisoners * patients are unable to fill prescriptions at the bcc pharmacy due to insurance limitations or personal preference

Keywords: breast cancer anti-estrogen therapy
evaluation of surgisis gold graft for incision reinforcement after open bariatric surgery

Conditions: Hernia; Obesity

Summary: the primary objective is to compare the effectiveness of the surgisis gold graft to suture closure alone in preventing an incisional hernia after open bariatric surgery.

this will be a prospective, randomized clinical trial comparing outcomes of use of a sublay of surgisis gold graft for tissue reinforcement, as compared to suture closure alone in evaluating incidence of incisional hernias. prior to undergoing open bariatric surgery, patients will be randomized to receive either surgisis gold graft or suture closure alone. subjects will be seen for follow-up visits at six weeks, three months, six months, one year and two years post-operatively. patients may see their primary care physician for the one and two follow-up visits.

Eligibility criteria:
inclusion criteria: * planned operative approach via upper midline incision with goal of weight loss * 18 years of age or older * body mass index (bmi) \>= 30 kg/m2 * documented history of non-surgical attempts at weight loss * patients undergoing reoperation for a failed previous bariatric procedure are eligible provided the operation is being performed for weight loss and provided at the time of reoperation there is no incisional hernia * patients with small, non-incarcerated, previously unrepaired umbilical hernias are acceptable provided the hernia defect is no greater than 2.5 cm in diameter exclusion criteria: * patients with pre-existing midline abdominal wall incisional hernia or diastasis rectus * patients undergoing repeat bariatric surgery for complications of a previous bariatric procedure * patients with a previous upper midline incision found to have an incisional hernia * patients with connective tissue disorders known to predispose to hernia formation * active infection at the time of proposed surgery * sensitivity or religious objections to porcine products

Keywords: biomaterials bariatric surgery hernia, prevention of obesity bypass surgery incisional hernia ventral hernia
opsite post-op visible wound dressings in treatment of surgical incisions

Conditions: Patients Undergoing Clean Surgery

Summary: opsite post-op visible is a tri-layer dressing made up of a low adherent wound contact layer, lattice shaped absorbent pad and a top film that is waterproof and a bacterial barrier and is coated with a water-based adhesive. the comparator is a standard care treatment regime comprising tape and gauze. this study requires 100 eligible patients which will be recruited from the patients routinely see by the study investigators at each study site. eligible patients will undergo surgery that results in a surgical wound of 27cm or less that is expected to have low or moderate levels of exudate and will have received at least one randomised study treatment. the primary objective is to compare opov and tape/gauze in terms of wear time per patient.

opsite post-op visible (opov) is a post-operative dressing that has been developed to protect the wound from bacteria in the environment and absorb blood or other fluid exuding from the wound. the honeycomb nature of the dressing pad allows direct visibility of the wound through the dressing, minimising the need to expose the wound to the environment and the patient to the trauma of a dressing change just for the clinician to inspect the wound. opov is unique in combining these features and offers a real benefit over other standard post-operative dressing regimes.

Eligibility criteria:
inclusion criteria: * patients undergoing "clean surgery" in an operating room * patients whose wounds will be closed surgically and not left to heal by secondary intention. * patients who are in-patients and are expected to be so for at least 5 days or are willing to return to the site for dressing changes. * patients who are at least 18 years of age.patients who understand the trial and are willing to consent to the trial * patients who are willing to attend the post-discharge follow-up assessment. * patients whose wounds are up to 27cm in length (as measured from end to end in a straight line) * patients whose wounds are expected to have low to moderate exudate. exclusion criteria: * pregnant or lactating females * patients undergoing chemotherapy, radiation therapy or taking any medication which is known to adversely affect wound healing * patients with a known medical condition or status known to delay or prevent normal wound healing such as diabetes, hiv, collagen vascular disorders and primary immune disorders * patients with a known sensitivity to any components of the investigational products or other similar dressings/products * patients with a history of poor compliance with medical treatment * patients who have participated in the study and who healed or were withdrawn. * patients who are unable to understand the aims and objectives of the trial.

Keywords: clean surgery