Kornimate/medical-research-clean huggingface dataset:
psychological mobile interventions to reduce distress

Conditions: Psychological Distress

Summary: investigating the effectiveness of two mobile psychological interventions and the mechanisms of change involved in reducing the symptoms of depression, anxiety and stress, on an adult population with a mild to moderate level of symptoms (sub-clinical).

the research design will be a 3-arm controlled clinical trial, with 4 waves of data collection. once selected using a symptomatic screening questionnaire, participants will be randomly assigned to one of three conditions: 2 experimental conditions (psypills and ocat) and an active control group (shamocat). measurements will be collected before allocation (baseline), during the intervention (through a momentary ecological assessment paradigm), at the end (post) and at an interval of one month after the intervention (follow-up). among the constructs evaluated are symptomatic level, affectivity, cognitive processes, emotional regulation and attentional bias. all measurement steps will be collected online. the interventions consist of an attentional training (online-contingent attention training, ocat) which seeks to facilitate the disengagement from the negative content and the engagement on the positive of some personally relevant information by providing instructions and feedback on performance; and prescribing personalized rational thinking strategies to change the intensity of dysfunctional emotionality (psypills). the active control group consists of a "fake" version of ocat (shamocat), by offering the same attentional training, without training and feedback on performance. all interventions are delivered in the form of smartphone applications.

Eligibility criteria:
inclusion criteria: * 18-65 years old * have access and able to use a smartphone

Keywords: mobile mental health mhealth attention bias training psychological distress digital cbt emotion regulation functional reappraisal rumination
aquagenic pruritus in myeloproliferative neoplasms

Conditions: Deciphering Aquagenic Pruritus in Myeloproliferaitive Neoplasms

Summary: description of the characteristics of aquagenic pruritus expressed by patients suffering from myeloproliferative neoplasms. prospective work based on the distribution of a dedicated questionnaire.

patients with myeloproliferative neoplasms identified and followed in french hospitals. patients could be followed for polycythemia vera or essential thrombocythemia or primary myelofibrosis. distribution of the questionnaire to each patient with myeloproliferative neoplasm (treated or not) suffering from aquagenic pruritus. analyse of each characteristic of the aquagenic pruritus by a statistician and publication at the end.

Eligibility criteria:
inclusion criteria: * patients with one of three non-chromosomal philadelphia-positive myeloproliferative neoplasms: polycythemia vera (pv), essential thrombocythemia (et), and primary myelofibrosis (pmf). * suffering (or having suffered) from aquagenic pruritus. * no age limit, but major * patient having formulated his non-opposition exclusion criteria: * patients with mpn with non-aquagenic pruritus, * patients with another hematologic disease and aquagenic pruritus * patients unable to complete the questionnaire. * patients with physical or mental disabilities to formulate non-opposition * refusal of participation

Keywords: pruritus myeloproliferative neoplasms
association between low cortisol levels and whiplash syndrome

Conditions: Injuries, Whiplash

Summary: the investigators hypothesis is that low (or low relatively to the situation) cortisol levels might be a causative factor of whiplash injury or post traumatic stress disorder following road accidents. in this study the investigators enroll patients who sustained a road accident. from all patients a blood sample will be withdrawn to measure cortisol concentrations. than, the patients will be divided into 2 groups: the study group will receive a single injection of intravenous hydrocortisone 100 milligram (a synthetic steroid used routinely for many years). the control group will receive a same volume of normal saline which would be used as a placebo treatment. the investigators assume that patients with low cortisol levels would tend to have a higher incidence of whiplash injuries and / or post traumatic stress disorders, and that a single bolus of hydrocortisone may prevent these untoward sequelas of trauma.

study protocol patients arriving during day time (08:00 - 16:00) to the soroka hospital emergency department following a motor vehicle accident and will be found eligible will be asked to participate in the study. following an informed consent the recruited patients will be randomly divided into a study group or a control group. from all the participants a volume of 5 milliliter of peripheral blood will be withdrawn for cortisol concentration determination prior to the study intervention. after withdrawing the blood sample patients will receive a single bolus of intravenous hydrocortisone 100 milligram (study group) or normal saline (0.9%) at a similar volume to that of the study drug, 5 ml (control group). patients will be otherwise receiving the regular management of a trauma patient. the enrolled patients will fill simple, short questionnaires including demographic data, neck disability index, (ndi), numeric pain rating scale (nprs), tampa scale for kinesiophobia (tsk-11), ptsd questionnaire (pda), and will be assessed by the treating physician for the degree of whiplash (wad 0-4). the patients will be followed-up by one of the investigators for a period of 6 months. in each visit the patient will be assessed again by the above mention tools. sample size: 45 patients in each arm. blinding and randomization: triple blinding and using a randomization software. statistical assessment will be performed to identify differences of developing wad (whiplash associated disorder) between patients who had an admission low level of cortisol compared with those who had a high or normal level, and also between patients who received hydrocortisone compared to those who received placebo.

Eligibility criteria:
inclusion criteria: * victims of motor vehicle accidents * signed informed consent exclusion criteria: * pregnancy * traumatic brain injury * psychiatry disorders * active cancerous conditions * adrenal diseases * medical treatment by estrogens, anti-depressants, melatonin, pain control. * substance abuse * hospitalization due to the trauma * contra indication to hydrocortisone treatment * over 6 hours from time of injury
real world, pharmacy-assessed adherence to new onset entresto® (sacubitril/valsartan) in patients with chronic heart failure

Conditions: Heart Failure

Summary: this is a multicenter, non-interventional, single arm cohort study with prospective collection of primary data via pharmacists in community pharmacies to describe adherence to sacubitril/valsartan in study patients at the end of the study. eligible patients with newly prescribed sacubitril/valsartan will be observed in pharmaceutical routine.

the study duration will last up to about 30 weeks per patient and will consist of a approximately three visits - baseline visit (v1), week 1-12 (v2) and week 13-30 (v3). no exact date for visit 2 and visit 3 will be enforced, to avoid interference with usual care.

Eligibility criteria:
inclusion criteria: 1. patients with first ambulatory sacubitril/valsartan prescription at screening 2. internet enabled device / smartphone (patient or affiliate) 3. ≥ 18 years of age 4. written informed consent to participate in the study exclusion criteria: 1. depression-related medication, depression-related comorbidities (patient-reported) 2. patients with unstable acute complications or with an advanced illness likely to interfere with participation in this trial as judged by the enrolling pharmacist 3. simultaneous participation in any interventional trial or simultaneous participation in another novartis-sponsored non-interventional study with sacubitril/valsartan

Keywords: heart failure nis germany sacubitril valsartan
comparison of effectiveness and complications of catheter lock solutions in non-tunneled hemodialysis catheters

Conditions: Catheter Blockage; Catheter-Related Infections; Dialysis Catheter; Thrombosis; Catheter Infection; Catheter Related Complication; Catheter Dysfunction

Summary: in our study, investigators will investigate the effectiveness and complications of two catheter lock solutions one of which is the standard heparin routinely used in comparison to sodium bicarbonate. both solutions were used but not compared head to head. investigators aim to compare both solutions in terms of catheter lumen patency and their effect on catheter-related infections.

the most important problem in patients with end-stage renal disease or patients with acute renal failure needing urgent hemodialysis treatment is the lack of appropriate vascular access. in acute situations, vascular access is usually provided by non-tunneled catheters. main problems with this temporaray vascular access is failure due to lumen thrombosis. anther major problem is catheter related infection. in some patients, there is a handicap of using heparin. in some situations, heparin is not preferred for use. in terms of the probable shortage of resources and cost-effectiveness, investigators aimed to compare head to head the superiority and non-inferiority of each solution. sodium bicarbonate was compared to the isotonic solution and found to be effective for a short time. the main aim of this study is to compare both classic heparin and sodium bicarbonate in femoral and jugular catheters aimed for dialysis. in both arms, the maximum patency and the observed side effects will be recorded. the maximal time used will be recorded. statistical analysis will be planned to compare the two groups.

Eligibility criteria:
inclusion criteria: * all patients over 18 years who assign consent will be included exclusion criteria: * patients less than 18 years of age * patients with active arterial or venous thrombosis problems * thrombocytopenic patients * patients with hypercoagulable states * patients with contraindications to heparin usage

Keywords: catheter lock solution sodium bicarbonate heparin non-tunneled dialysis catheter
a trial to evaluate safety of firmagon® (degarelix) in indian patients diagnosed with advanced hormone-dependent prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this open-label, single-arm, multicenter, post-marketing trial is to evaluate long-term safety of firmagon® in approximately 230 indian patients diagnosed with advanced hormone-dependent prostate cancer requiring androgen deprivation therapy.


Eligibility criteria:
inclusion criteria: * has given written informed consent before any study-related activity is performed * advanced hormone-dependent prostate cancer for which androgen deprivation therapy is indicated, and independently from this trial, firmagon® is intended to be used for treatment * age greater than or equal to 18 years and less than 80 years * advanced hormone-dependent prostate cancer without any other clinically significant disorder * easten cooperative oncology group score ≤ 2 * psa ≥ 2 ng/ml at screening * life expectancy of at least 12 months as per the investigator's judgement exclusion criteria: * previous or concurrent hormonal management of prostate cancer * contraindication for prescription of firmagon® * concurrent treatment with a 5-α-reductase inhibitor * considered as a candidate for curative therapy * history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema * qtc interval over 450 msec or risk factors for torsades de pointes or on class ia and class iii anti arrhythmic medications * cancer within the last 5 years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin * known or suspected hepatic, symptomatic biliary disease (this includes moderate to severe chronic hepatic impairment) * patients with clinically significant laboratory abnormalities / disorders other than prostate cancer * patient with hepatitis b virus (hbv), hepatitis c virus (hcv) and human immunodeficiency virus (hiv) infections
paracervical block in laparoscopic hysterectomy

Conditions: Uterine Fibroid; Adenomyosis

Summary: it remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in total laparoscopic hysterectomy (tlh), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to tlhs for benign gynecologic conditions on postoperative pain relief.

postoperative pain management is an important component of patient care and satisfaction after surgery. although contemporary changes such as a shift to minimally invasive approaches and an introduction of the enhanced recovery after surgery (eras) program have resulted in improved outcomes, a large number of patients undergoing surgery have still inadequate pain control. paracervical block is a single-injection of anesthetic around the cervix at a depth of about 1 cm, diffusing anesthetic into the second to fourth sacral nerve roots passing through frankenhäuser plexus. moreover, recent randomized trials demonstrated that patients who underwent vaginal hysterectomy and received a paracervical block had lower postoperative pain in the first 3-6 hours compared with placebo. however, it remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in total laparoscopic hysterectomy (tlh), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to tlhs for benign gynecologic conditions on postoperative pain relief.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * american society of anesthesiologists physical status (asaps) classification i-ii * the absence of pregnancy at the time of surgery exclusion criteria: * history of cervical surgery such as conization or cerclage * inability to perform the paracervical block due to anatomical abnormalities (i.e., very atrophic or small cervix) * allergy to bupivacaine, planned concomitant surgical procedures involving extensive additional tissue manipulation such as pelvic lymph node dissection * any concomitant surgery of pelvic floor repair (uterosacral ligament suspension or sacrocolpopexy) or vaginal procedures (anterior or posterior colporrhaphy or mid-urethral slings), previously taking opioids for chronic pain * inability to accurately express their pain
normothermia protocol for traumatic brain injury patients

Conditions: Traumatic Brain Injury

Summary: comparison between a normothermia protocol and current protocol (acetaminophen plus blankets) 1. normothermia protocol is successful in achieving and maintaining normal temperature in moderate to severe traumatic brain injury (tbi) patients.(using arctic sun for 96 hrs from admission to neuro icu) 2. normothermia is translated into improved neurologic outcome and survival compared to standard of care (physician management)


Eligibility criteria:
inclusion criteria: * severe tbi patients(gcs 3-9) admitted to icu exclusion criteria: * less than 18 years old. * bleeding disorders. * pregnancy/breastfeeding. * hepatic encephalopathy. * spinal cord injury (know or new) * fever \>100 f prior to randomization. * blood alcohol level \>80 * participation in other research trial. * inability/unwilling to obtain informed consent. * terminal illness(not expected to survive 3-6 months) * not expected to survive 24 hrs.

Keywords: normothermia fever control outcome study
study evaluating pantoprazole in neonates and preterm infants with gerd

Conditions: Gastroesophageal Reflux

Summary: the purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed gastroesophageal reflux disease.


Eligibility criteria:
inclusion criteria: * hospitalized patients * presumed diagnosis of gerd * term or post-term infants within the neonatal period less than 28 days or preterm infants with a corrected gestational age of less than 44 weeks exclusion criteria: * cardiovascular instability * clinically significant laboratory abnormalities * use of warfarin, carbamazepine, phenytoin, or rifampin

Keywords: safety
deep neuromuscular block on cytokines release and postoperative delirium

Conditions: Hip Fractures

Summary: the purpose of the study is to determine the relationship between the degree of neuromuscular block, the release of cytokines and clinical outcomes in elderly patients undergoing orthopedic surgery. investigators hypothesize that deep neuromuscular blockade decreases the release of cytokine and the incidence of postoperative delirium in elderly patients undergoing orthopedic surgery, compared with moderate neuromuscular blockade.

* study design - this is a prospective, randomized, single blinded study. * measurement values * neuromuscular monitoring by post-tetanic count (ptc) during operation * regional cerebral oxygen saturation monitoring * mean systemic blood pressure (mbp), heart rate (hr) * cardiac index (ci), using non-invasive cardiac output monitor * il-1ß, il-6, tnf-α, il-10 and crp * arterial blood gas analysis (abga) * laboratory values \[hemoglobin, hematocrit, serum albumin, creatinine, cpk, ldh\] * postoperative pain, using visual analogue scale (vas) * postoperative nausea and vomiting (ponv) * total infused amounts of drugs * total anesthesia duration, intubation duration and operation duration * intubation duration, operation duration * incidence of postoperative intensive care unit (icu) admission * total icu staying duration, if patients admit to icu * preoperative and postoperative left ventricular ejection fraction change * incidence of hypotension (mean blood pressure lesser than 60 mmhg) * incidence of postoperative delirium using confusion assessment method (cam) intensive care unit (icu) * total amount of blood products transfusion (paced red blood cells, fresh frozen plasma, platelet concentration, cryoprecipitate) * total amount of crystalloids and colloids infusion * total amount urine output

Eligibility criteria:
inclusion criteria: * all adult (more than 50 years old) patients scheduled for total hip arthroplasty and total knee arthroplasty who have signed the written informed consent. exclusion criteria: * inability to give informed consent * preexisting cognitive dysfunction or delirium * known allergy to rocuronium sugammadex * underlying liver dysfunction (ast and alt more than 100 iu/l) * underlying kidney dysfunction (serum creatinine more than 1.5 mg/dl) * underlying neuromuscular disease * patients taking any medication with potential interference with neuromuscular transmission
cytokine expression in psoriasis patients with and without joint involvement

Conditions: Psoriasis; Psoriatic Arthritis

Summary: the objective of the resarch is to study the cytokine profile of patients with psoriatic arthritis and psoriasis in order to better understand the pathophysiology of the disease and the contribution of cytokines to the presence or absence of joint involvement. this research will compare cytokines levels in sera, in pbmc culture after lps or cd3/cd28 agonist antibodies, and in skin biopsy.

psoriatic arthritis and cutaneous psoriasis are polygenic inflammatory disorders with high burden on the quality of life of patients. pathophysiology of those disease remain incompletely understood. recent publications seem to demonstrate an implication of il-1 family cytokines in the pathogenesis of both diseases. in the literature, results are discordant and focus mainly on cytokines levels in serum of patients. moreover, few studies compare psoriatic arthritis patients with cutaneous psoriasis patients. we propose here to study cytokines profiles of patients with those conditions in sera, after ex-vivo stimulation of peripheral blood mononuclear cells, and in skin biopsies.

Eligibility criteria:
inclusion criteria: * for psoriasis patients : * age over 18 years old * signed informed consent * 5 year old psoriasis at least * at least one skin lesion over 2 cm * without any articular symptoms * without any dmards * without anticoagulant treatments or coagulation disease * with normal articular and enthesis sonography * for psoriatic arthritis patients : * age over 18 years old * signed informed consent * psoriatic arthritis according to caspar criteria * without any dmards * without anticoagulant treatments or coagulation disease * with at least one synovitis at inclusion * for controls * age and sex matched with a patient without any rheumatic or dermatologic medical conditions * no treatment with corticosteroïds or non-steroïdial anti-inflammatory drugsage over 18 years old exclusion criteria: ▪ for psoriasis patients : * joint damage according to caspar criteria * echography activity in favor of chronic inflammatory rheumatism * for patients and controls: * without social protection rights * people under judiciary protection, of less than 18 years old, pregnant woman, breast feeding women, jailed patients.
assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia

Conditions: Erectile Dysfunction

Summary: assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia


Eligibility criteria:
inclusion criteria:- age: 18 years and older- males with erectile dysfunction- stable heterosexual relationship- medical history / diagnosis of diabetes mellitus and/or hypertension and/or hyperlipidemia exclusion criteria:- primary hypoactive sexual desire- history of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- nitrate use- other exclusion criteria apply according to summary of product characteristics

Keywords: erectile dysfunction diabetes mellitus hypertension hyperlipidemia vardenafil