Kornimate/medical-research-clean huggingface dataset:
the effects of fatigue on exercise-induced hypoalgesia during a dynamic resistance exercise

Conditions: Healthy

Summary: the primary purpose of this study is to compare immediate changes in pain sensitivity (pressure pain threshold) during quiet rest, low fatigue exercise, and high fatigue exercise.

participants will attend three sessions. participants will fill out questionnaires, undergo pain sensitivity testing, and be randomly assigned to complete a high and low fatigue exercise on either the second or third session. during the exercise, participants will complete three sets of a single leg knee extension exercise with weight equivalent to 50% of their 1 repetition maximum until they report either a high or low fatigue level. immediately before and after each set, the research team will examine immediate changes in sensitivity to pressure (pressure pain threshold).

Eligibility criteria:
inclusion criteria: * pain-free * 18-60 years old * participant can appropriately perform the knee extension exercise (assessed during screening) exclusion criteria: * non-english speaking * regular use of prescription pain medications * current or history of chronic pain condition * currently taking blood-thinning medication * systemic medical condition known to affect sensation, such as uncontrolled diabetes or neurological conditions * any contraindication to the application of ice, such as: uncontrolled hypertension (blood pressure over 140/90 mmhg), cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise * known presence of cardiovascular, pulmonary, or metabolic disease * current use of tobacco products * not physically ready to exercise without a medical exam as indicated by the physical activity readiness questionnaire plus (par-q+) * surgery, injury, or fracture to the lower back or lower extremity within the past 6 months
cost-effectiveness of interventions in first-episode psychosis

Conditions: Schizophrenia

Summary: schizophrenia has very significant economic consequences. costs fall on many different parts of society, especially on individuals with schizophrenia and their families. the first five years after onset appears to be a critical period in which the symptoms are more responsive to treatment. in addition, if left untreated for a long time, psychosis can impact many areas of a person's life. the evidence base regarding the effectiveness of specialist early intervention services for psychosis has grown steadily and evidence from randomized controlled trials in denmark, the united kingdom and spain has demonstrated the superiority of specialized early intervention programs over standard care on a broad range of outcomes including symptomatic and vocational, social functioning, and reduced inpatient care and treatment dropout, as measured over follow-up intervals of 2-3 years. information about the cost-effectiveness of early intervention programs for first-episode psychosis is limited. the provision of such services requires investment by health departments and services, and the question of whether such services represent value for money has to date received little research attention. only a few international studies, and none conducted in spain, have investigated the cost effectiveness of early intervention in psychotic disorders at medium (3 years) and long-term (up to 10 years). in this study, the investigators aimed to analyse the cost-effectiveness of an intensive early-intervention programme, using data from first episode psychosis clinical program (pafip), the largest trial treating first episode non-affective psychosis in spain to date.


Eligibility criteria:
inclusion criteria: * meeting diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria for a principal diagnosis of schizophreniform, schizophrenia, schizoaffective, brief reactive psychosis, or psychosis non otherwise specified. * living in the catchment area. * no prior treatment with antipsychotic medication or, if previously treated, a total life time of adequate antipsychotic treatment of less than 6 weeks. * current psychotic symptoms of moderate severity or greater assessed by one of the five items of the scale for the assessment of positive symptoms (saps). * first episode patients with at least one assessement at 3 years or 10 years. exclusion criteria: * meeting dsm-iv criteria for mental retardation. * meeting dsm-iv criteria for drug dependence.

Keywords: schizophrenia psychosis effectiveness
genetic research in schizophrenia using dna markers and clinical phenotypes

Conditions: Schizophrenia

Summary: schizophrenia has long been known to be an illness with significant evidence for a genetic predisposition. the purpose of this study is to determine the genetic abnormalities that cause childhood and adult onset schizophrenia.

it is known from genetic linkage and gene expression studies that the alpha 7 nicotinic receptor gene is abnormally expressed in people with schizophrenia. the immediate objectives of this proposal support the long-term objectives of a comprehensive description of the pathophysiology of schizophrenia and new drug treatments by carefully defining the physiological genotype-phenotype relationship for a single candidate gene. subjects and family members with a mental illness or who appear to have a mental illness will be asked to undergo an interview, perform some mental tests and have a blood, urine, and saliva sample taken one time.

Eligibility criteria:
inclusion criteria: * individuals thought to have schizophrenia or schizoaffective disorder, be the parent of such an individual, or be in the matched control group of unrelated individuals not thought to have schizophrenia or schizoaffective disorder exclusion criteria: * unable to give informed consent; * psychotic disorder judged to be secondary to substance abuse, psychotic disorder that appears to be secondary to a known medical or neurological disorder, or severe mental retardation

Keywords: schizophrenia
phase ii trial of decitabine in patients with chronic myelogenous leukemia blast phase who are refractory to imatinib mesylate (gleevec)

Conditions: Chronic Myelogenous Leukemia

Summary: to determine the safety and efficacy of decitabine in patients with philadelphia chromosome-positive chronic myelogenous leukemia blastic phase that were previously treated with imatinib mesylate (sti 571) and became resistant/refractory or were found to be intolerant to the drug.


Eligibility criteria:
inclusion: * histologically confirmed diagnosis of cml blast phase * ph chromosome-positive * previous treatment with imatinib mesylate resulting in: i) hematologic resistance / hematologic refractory: based on a physician's (documented) decision to discontinue imatinib mesylate treatment due to failure of continued benefit or no benefit to the patient, ii) imatinib mesylate intolerance: any toxicity resulting in a physician's (documented) decision to discontinue imatinib mesylate treatment. * patients must have recovered from the side effects of previous cml therapy for blast phase with the exception of hydroxyurea * age \>/= 2 years * bilirubin \</= 3 x the upper limit of normal (uln), sgot and sgpt \</= 3 x uln, except \</= 5 x uln in leukemic involvement of the liver, serum creatinine \</= 2 x uln * who performance status 0-3 * a negative serum hcg pregnancy test in patients of childbearing potential * able to give signed informed consent directly or through a parent or guardian for minors exclusion: * leukemic involvement of the central nervous system * active malignancy other than cml or non-melanoma cancer of the skin * previous treatment for cml with another investigational agent within 28 days of study entry * at study entry, patients who were treated with: imatinib mesylate within the past 48 hours, interferon-alpha within the past 48 hours; homoharringtonine within the past 14 days; low-dose cytosine arabinoside within 7 days, moderate dose within 14 days, or high dose within 28 days; etoposide, anthracyclines, or mitoxantrone within 21 days; busulfan within the past six weeks * patients who had received hematopoietic stem cell transplantation within 6 weeks of day 1 decitabine therapy * patients with grade 3/4 cardiac disease or any other serious concurrent medical condition. * patients who are pregnant or nursing. all patients of childbearing potential must practice effective methods of contraception while on study. * patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements * patients with systemic, uncontrolled infections

Keywords: chronic myelogenous leukemia cml cml-bp blast phase decitabine 5-aza-2'deoxycytidine methylation sti 571 imatinib mesylate gleevec bcr/abl
influence of fampridine on working memory in healthy subjects

Conditions: Working Memory

Summary: proof-of-concept study on the effects of 10 mg fampridine (oral administration) on working memory in healthy participants. the hypotheses is that fampridine improves working memory performance.


Eligibility criteria:
inclusion criteria: * male or female * generally healthy * normotensive (bp between 90/60 mmhg and 140/90 mmhg) * bmi between 19 and 29,9 kg/m2 * aged between 18 and 30 years * fluent german-speaking * informed consent as documented by signature exclusion criteria: * contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to 4-aminopyridine * use of potassium channel blockers within the last 3 months * concomitant treatment with oct 2 inhibitors (e.g. cimetidine, propranolol) * acute or chronic psychiatric disorder (e.g. major depression, psychoses, somatoform disorder, suicidal tendency) * acute cerebrovascular condition * history of seizures * risk of lowered seizure threshold (due to e.g. sleep deprivation, withdrawal of alcohol after alcohol abuse) * renal impairment * history of malignant cancers * walking problems (e.g. due to dizziness) * other clinically significant concomitant disease states (e.g. hepatic dysfunction, cardiovascular disease, diabetes, asthma) * clinically significant laboratory or ecg abnormality that could be a safety issue in the study * known or suspected non-compliance * drug or alcohol abuse * inability to follow the procedures of the study, e.g. due to language or psychological problems of the participant * participation in another study with an investigational drug within the 30 days preceding and during the present study * prior participation (less than two years ago) in a study investigating working memory (notably the n-back task) * enrolment of the investigator, his/her family members, employees and other dependent persons * smoking (\>3 cigarettes per day) * intake of psychoactive drugs (e.g. benzodiazepines, antidepressants, neuroleptics) * pregnancy or breast feeding
medullary stimulation for the treatment of refractory neck pain (s2m)

Conditions: Pain, Intractable

Summary: number of centres planned : 1 (chu nantes) design : randomized, prospective planning of the study : * total duration: 34 months * recruitment period: 24 months. * follow-up time per patients : 7-10 months expected number of cases : 12 treatment, procedure, combination of procedures under consideration : during the study, patients will be implanted with the wavewriter alpha™ system with the objective of decreasing patient pain with a spinal cord stimulation mode. there will be a random draw on the order of the stimulation program: * the tonic stimulation "lf": in tonic mode, the electrical stimulation of the sensory fibers of the posterior cords of the spinal cord induces local paresthesias * burst stimulation (or "burst") * high frequency" stimulation (1000 hz) "high frequency: hf". * combined tonic + burst stimulation * combined tonic + high frequency stimulation


Eligibility criteria:
inclusion criteria: * patients aged 18 to 85 years * patients with chronic neck and upper limb pain (according to has criteria for spinal cord stimulation) * patients must be able to give informed consent and must have signed an informed consent * affiliation to the health insurance * a negative pregnancy test for women of childbearing potential * women of childbearing potential must use an appropriate contraceptive method(s) during the clinical trial non-inclusion criteria: * drug or alcohol abuse * any medical or psychological problem that may interfere with the proper conduct of the study protocol (e.g., cancer with limited life expectancy) * difficulty with follow-up * pregnant or breastfeeding women * women of childbearing potential who are not using contraception * adults under legal protection (guardianship, curatorship, "sauvegarde de justice") or deprived of liberty * exclusion period for another study * participation in another interventional study whose primary objective is based on pain. exclusion criteria: - 7-day post-implantation test phase negative

Keywords: medullary stimulation refractory neck pain
anesthesia depth increases delirium incidence

Conditions: Delirium; Anesthesia Awareness

Summary: this study aimed to determine whether targeting bispectral index (bis) readings of 55 (light anaesthesia) was associated with a lower incidence of delirium, dementia (pod), pocd and mortality but higher rates of awareness and complications than a standard of care anaesthesia blinded to depth monitoring.

design: randomised-controlled, double blind study, monocentric setting: level 2 medical center, major surgery (non cardiac) ethics: ethical approval for this study (ethikkommission ii der ruprecht-karls-universität heidelberg 2013-627n-ma) was provided by the ethical committee ii university medicine mannheim, university of heidelberg, germany (chairperson prof w. striebel) on mai 12th 2008. patients: n=130, aged \> 70y intervention: light anesthesia (bis 55 +/-5) vs. standard of care (bis- blinded) main outcome measures: incidence of awareness, delirium, postoperative cognitive deficit (pocd), dementia (pod), memory (mat with a computerized score for verbal working\&short term, figural working\&short term memories and well as attention level) second aims: mortality, complications

Eligibility criteria:
inclusion criteria: * scheduled for major surgery above 60 min duration * informed consent exclusion criteria: * emergency surgery with large blood loss and/or preoperative cardiovascular instability, scheduled regional or neuraxial anesthesia, language barriers with the unability to understand a german audio tape, unability or unwillingness to consent,hearing disabilities

Keywords: bispectral index monitoring anesthesia depth
influence of diabetes on lower limb amputation

Conditions: Diabetes; PAD

Summary: the purpose of this study is to explore the factors that influence limb fitting in those with diabetes compared to those without diabetes. the population without diabetes will usually present with peripheral arterial disease (pad) and are similar in management following lea. the impact that not walking with a prosthesis has long term on both populations will be explored. in general, previous research has used retrospective analysis of case notes which, although valuable, have fixed fields and only allow the researcher to look at associations between factors not at causation. additionally, very few have followed a population over time. therefore this study will be a prospective observational analysis of all those who undergo a lea in one year from 01/03/14 to 28/02/15 within the greater glasgow \& clyde area with follow up at 6, 12 \& 18 months from date of amputation.

this research has been designed to ask the following question: what are the factors that influence the rehabilitation and functional outcomes following lea, in the long term in both those with and without diabetes. therefore this study will be a prospective observational analysis of all those who undergo a lea in one year within the greater glasgow \& clyde area with follow up at 6, 12 \& 18 months from date of amputation. * primary endpoint comparison of rehabilitation and functional outcomes in those with diabetes to those without diabetes, up to 18 months post lea. * secondary endpoints 1. at discharge from rehabilitation, the characteristics of those who proceed to limb fitting following lea to those who do not will be defined. 2. at discharge from rehabilitation, the characteristics of those with diabetes that do not proceed to limb fitting following lea compared to those who do. 3. at discharge from rehabilitation to 18 months post lea, a comparison of the characteristics in those with and without diabetes. 4. from six months post lea, at 6 monthly intervals (6,12 \& 18 months), a comparison of the health status, social circumstances, mobility and quality of life measures in those with and without diabetes.

Eligibility criteria:
inclusion criteria: * over 18 years of age with a major amputation above the ankle. exclusion criteria: * amputation for tumour, trauma, congenital abnormalities * amputation at hip disarticulation or trans-pelvectomy level * adults with incapacity

Keywords: amputation
influence of hla-dqa1*05 genotype in adults with anti-tnf treatment with proactive therapeutic drug monitoring.

Conditions: Drug Monitoring; Inflammatory Bowel Diseases

Summary: hla-dqa1\*05 variant carriers are at risk of developing antibodies against infliximab and adalimumab with reduced tnf antagonist persistence. the impact of proactive therapeutic drug monitoring (ptdm) on this association has been barely assessed. therefor, we propose a cohort study including adult patients with crohn's disease and ulcerative colitis treated with tnf antagonists under proactive therapeutic drug monitoring. our hypothesis is that, proactive therapeutic drug monitoring could be an alternative to combination treatment with immunomodulators to increase tnf-antagonists' persistence in hla-dqa1\*05 carriers.

population study: patients with inflammatory bowel disease and initiation of anti-tnf therapy inclusion and exclusion criteria the inclusion criteria are: * patient diagnosed with inflammatory bowel disease based on clinical, endoscopic, and pathological criteria according to ecco criteria. * initiation of anti-tnf, including infliximab and adalimumab. * subjects naïve to biological treatment * age \>18 years. the exclusion criteria are: * no determination of hla dqa1\*5 allele. * no proactive drug monitoring * initiation of anti-tnf treatment as prevention of post-surgical recurrence in crohn's disease during the first 12 months after surgery or, after that time, with a colonoscopy with a rutgeerts 0-1 * anti-tnf treatment with combined treatment with immunomodulator. prior initiation of immunomodulator or prior use and suspension would not be a contraindication * initiation of anti-tnf treatment for extraintestinal manifestation * initiation of anti-tnf treatment during pregnancy. proactive drug monitoring was defined as standardized determination of drug levels during induction and maintenance, with optimization independently of the patient's clinical status, until reaching target levels.

Eligibility criteria:
inclusion criteria: * diagnosis of inflammatory bowel disease according to ecco criteria. * older than 18 years * subjects naïve to biological treatment * anti-tnf treatment initiation (infliximab or adalimumab) due to intestinal activity and/or perianal disease. * avaibility to evaluate hla dqa1\*05 status * proactive therapeutic drug monitoring of anti-tnf levels exclusion criteria: * initiation of anti-tnf treatment as prevention of post-surgical recurrence in crohn's disease during the first 12 months after surgery or, afterwards, if endoscopic recurrence with a rutgeerts 0-1. * initiation of anti-tnf treatment under combo treatment with immunomodulator. prior initiation of immunomodulator or prior use and suspension would not be a contraindication. * initiation of anti-tnf treatment due to extraintestinal activity. * initiation of anti-tnf treatment by a non-gastroenterologist specialist. * initiation of anti-tnf treatment during pregnancy.

Keywords: proactive therapeutic drug monitoring hla-dqa1*05 genotype anti-tnf
early use of rosuvastatin in acute coronary syndromes: targeting platelet-leukocyte interactions

Conditions: Acute Coronary Syndrome; Angioplasty, Transluminal, Percutaneous Coronary; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Blood Platelets

Summary: the central hypothesis for this work is that platelet - leukocyte interactions play a critical role in the pathogenesis of acute ischemic events. the primary objective of the study is to determine if early, high-dose administration of the hmg-coa reductase inhibitor rosuvastatin in the setting of acute coronary syndrome and percutaneous coronary intervention exerts beneficial vascular effects by reducing platelet - leukocyte interactions.


Eligibility criteria:
inclusion criteria: 1. subjects must be between 18 and 80 years old. 2. subjects must be willing and able to give informed consent 3. a woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for up to 30 days after enrollment. 4. subjects must have symptoms of acute coronary syndrome as defined by 2 of the 3: (a) history of cardiac-ischemia-related symptoms of at least 10 minutes duration ≤ 8 hours prior to randomized treatment assignment (b) concurrent biomarker evidence of cardiac ischemia, as defined by troponin i or t greater that upper limit of normal (uln) or creatine kinase-myocardial band (ck-mb) greater than uln. (c) concurrent electrocardiographic evidence of cardiac ischemia, as defined by new of presumably new st-segment depression (≥1 mm) or transient (\<30 min) st-segment elevation (≥ 1mm) in at least two contiguous leads. 5. subjects must be statin naive or currently only on low dose statin (simvastatin 20mg, pravastatin 40mg, or atorvastatin 10mg) exclusion criteria: * age \<18 years * age \> 80 years * use of crestor in the past 30 days * gfr (estimated) \<30 ml/min * hemodialysis * history of liver failure * unexplained liver function abnormalities * current or planned use of cyclosporine or gemfibrozil * sepsis * hypotension * dehydration * trauma * severe metabolic, endocrine or electrolyte abnormality * recent (within the last 2 weeks) or planned (in the next month) major surgery * hiv/aids with current of planned use of hiv protease inhibitors

Keywords: platelet activation platelet leukocyte aggregates