Kornimate/medical-research-clean huggingface dataset:
the detect study - delirium in elderly patients admitted to trauma

Conditions: Delirium; Bone Fractures; Multiple Trauma

Summary: primary objectives are to define incidence and prevalence of delirium in an elderly population admitted to the department of orthopedics and traumatology and, in the postoperative phase, in the high dependency unit as well as to determine the presence of risk factors. secondary objectives are to determine mean hospital stay, rates of complications as well as in-hospital mortality and at 1-3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 moths follow-up.

the aging of population as well as the increased life expectancy put progressively urgent demands about the adequacy of the level of care provided in a hospital environment to ensure clinical pathways tailored on the needs of each individual patient. on the other hand, the gradual evolution of health care systems to care for the acute, with increasing levels of specialization often technologically driven, cannot and must not neglect these aspects of personalization of care protecting the elderly "frail" patient, because of its intrinsic characteristics. in such a context, evaluation of frailty undertakes not only the meaning of prevention and promotion of quality of life but it takes in account important issues for patient's safety and the economic weight it entails. delirium (acute confusional state) is a complex syndrome which frequently occurs in the elderly hospitalized population. development of delirium is associated with negative outcomes such as a longer hospital stay, a higher rate of complications, cognitive and functional decline, loss of independence, institutionalization, and, ultimately, death. for skilled healthcare professionals, on the other hand, it represents a challenging condition because a prompt and accurate diagnosis with the introduction of all those prevention and non-pharmacological measures may reduce the incidence, severity and/or duration of delirium and improve functional recovery. therefore the meaning of conducting such an observational study is also to provide evidence of patients' needs and address the on-ground educational aspect for healthcare professionals in a daily practice. the purposes of the study are to determine the incidence and prevalence (before and after surgery) of delirium in an elderly population admitted to the department of orthopedics and traumatology and in the high dependency unit in the postoperative phase as well as to determine the risk factors for developing such a condition. secondary objectives are mean hospital stay, rates of complications as well as in-hospital mortality and at 1, 3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 months follow-up.

Eligibility criteria:
inclusion criteria: * patients with any medical condition with an age of 65 years and older exclusion criteria: * impossibility to give an informed consent; refusal
environmental influence on gambling behavior

Conditions: Pathological Gambler

Summary: in france, the prevalence of problem gambling and risk has been estimated at 1.3%. this disorder, currently considered a behavioral addiction is characterized by a loss of control and an excessive focus on the game. the literature on intervening psychological mechanisms in the development of the game led to think that the size of loss of control, central among players, could be understood as a reduction in control capacity but also as automatic activation behavior game. the task of go-nogo, commonly used in cognitive psychology, assesses the automatic and controlled components of behavior. furthermore, different models of the concept of addiction underline the importance of the environment associated with addiction. however, no study takes into account the interaction between the game environment and the involvement of these mechanisms.

in this study, patients will realize, on a computer, various exercises (called "go-nogo") whose principle is: 2 symbols (for example, a circle and a square) appear in random order on the screen computer. the patient will not press the response button (key on the keyboard) that upon the occurrence of one of the two symbols, in dependence upon the command that it has been given by the psychiatrist, and this as quickly as possible. the patient will successively perform 3 versions of this exercise (with a neutral wallpaper, with neutral/games images or with neutral/games tones).order of the 3 versions will be determined by randomization.

Eligibility criteria:
inclusion criteria: * for pathological gambler (jp): active casino players meet the diagnostic criteria for pathological gambling according to dsm-iv-tr * for social player (js): casino players who score the sogs is less than or equal to 2, and playing at least once a month in a money game and chance. * for non-gamer witnesses (t): play less than once per month to any type of gambling, except for lotto and euromillion where the threshold is increased at least once a week. these two draw games are considered more socially enrolled in a leisure practice without necessarily enroll in gambling. * right handed * aged between 18-60 years. * without psychotropic treatment or treatment with a stable and unchanged for over a month. exclusion criteria: * participants with a problem of visual acuity and / or uncorrected hearing. * other current addiction (except tobacco, for reasons of feasibility). * current psychiatric comorbidity * treatment psychotropic introduced or changed for less than a month. * subjects with atrial fibrillation, with a pacemaker and / or receiving antiarrhythmic drugs

Keywords: pathological gambler go-nogo test
interleukin-6 inhibitors and drug-drug interactions in patients with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid; Interaction

Summary: with this study the investigators aim to assess if drug metabolism changes in patients with rheumatoid arthritis when an interleukin (il)-6 inhibitor is initiated. patients with rheumatoid arthritis have an increased level of inflammation in the body which can lead to decreased expression and activity of drug metabolizing enzymes in the liver. this will lead to a decreased metabolism and excretion of drugs. the inflammation is driven by a number of proinflammatory cytokines e.g., il-6. the investigators hypothesize that patients with rheumatoid arthritis initiating treatment with an il-6-receptor inhibitor (anti-il-6r) will obtain a normalization of the activated il-6-pathway resulting in increased expression and activity of drug metabolizing enzymes and hence increased metabolism. ultimately, this normalization of drug metabolism could lead to insufficient efficacy of a wide variety of drugs. the investigators will perform a clinical pharmacokinetic trial. the study will include patients with active rheumatoid arthritis and a need to initiate treatment with an il-6 receptor antibody. patients will ingest a 6-drug cocktail consisting of probes for specific cyp enzymes. plasma and urine will be drawn over 6 hours to determine concentrations of the drugs and their metabolites. patients will then initiate il-6 receptor antibody treatment and to assess both short- and long-term impact of altered inflammation, the same 6-drug cocktail will be ingested, and concentrations measured, after three weeks and three months. to help understand the mechanism and the putative involvement of inflammation, markers of inflammation such as cytokines, transcription factors, etc. will also be assesses.


Eligibility criteria:
inclusion criteria: * active rheumatoid arthritis * age 18-75 years * egfr \> 30 ml/min * absolute neutrophil count (anc) ≥ 2 x 109 /l * platelet count \> 150 x 103 /μl (corresponding to \>150 x 109 /l) * alat in the normal range or within 1.5x the upper limit of normal. * use of effective contraception (only woman of childbearing potential) * negative test for hepatitis and tuberculosis exclusion criteria: * known sensitivity to any of the medications used. * active severe infections * malignancy * diverticulitis * intake of medications which can influence the safety of the patient or the results of the study. can include prescription medications, over-the-counter medications, herbal medicines or dietary supplements. will be assessed by the investigators. * participation in other clinical intervention trials. * pregnancy or breastfeeding
daily vinegar ingestion and metabolic health

Conditions: Inflammation; Metabolic Syndrome; Depression

Summary: the purpose of this study is to determine if vinegar ingestion promotes beneficial changes to metabolic health parameters in healthy, overweight adults.

recent research, in animal and human subjects, suggests that vinegar intake is inversely associated with insulin resistance, mood states and depression, inflammation, and other disease parameters. the study will be conducted as a randomized controlled trial in overweight adults to further examine these relationships and possible mechanisms. although the mechanisms are not known, research suggests that changes in the gut microbiome, a response to the ingestion of the postbiotic acetic acid, may factor into the beneficial effects of vinegar ingestion. through analyses of blood, changes in key blood metabolites associated with mood states (e.g., gamma-aminobutyric acid) as well as markers of gut health (e.g., lps binding protein) and inflammation (e.g., crp) will be assessed. additionally mood state will be assessed using validated measures and determine risk for metabolic syndrome, a cluster of risk factors associated with many chronic conditions. it is hypothesized that vinegar ingestion will promote beneficial changes to these health parameters.

Eligibility criteria:
inclusion criteria: * healthy * non-smoker * free of chronic disease by self-report * able to speak, read, and understand english * able to consent. * bmi ≥ 25 and ≤ 35 exclusion criteria: * adherence to specific diets for weight loss * vegetarian * report gerd or regular heartburn * unwilling to consume vinegar daily for 4 weeks * pregnant or lactating women * recreational drug use, alcohol intake above recommendations (1 drink/day for women, 2 drinks/day for men - or none) * competitive level physical training (e.g., physical activity above recommendations as set by the physical activity guidelines for americans) * scoring 1 or higher on question 9 of the phq-9 questionnaire.

Keywords: vinegar acetic acid lps
behavioral activation in orthopaedic trauma patients: a pilot study

Conditions: Fractures, Bone

Summary: this is a prospective observational pilot study designed to evaluate feasibility and acceptability as well as preliminary efficacy of a behavioral activation intervention among orthopaedic trauma patients after discharge home following their injury.

this is a prospective observational pilot study designed to evaluate feasibility and acceptability as well as preliminary efficacy of a behavioral activation intervention among orthopaedic trauma patients after discharge home following their injury. behavioral activation is a behavioral treatment that focuses on helping participants engage in more rewarding and enjoyable activities. in the first session, participants will begin to identify domains of their life which are important to them. in the second session, participants will be assisted in creating an action plan to engage in more activities in one or more domains of importance. in session 3-8, participants will be assisted in problem solving any challenges they encountered in implementing their previous action plan and will develop a new action plan. the intervention will continue until participants achieved three action plans or reach the eight-session limit, whichever comes first.

Eligibility criteria:
inclusion criteria: * patients 18 years or older * presenting at initial (approximately 2-week) postoperative follow-up * prior management of isolated fracture or multi-trauma exclusion criteria: * incarceration * problems, in the judgement of study personnel, with maintaining follow-up * cognitive disability (either acute or chronic)
a study of the immunogenicity and safety of the 2006-2007 influenza vaccine

Conditions: Influenza; Orthomyxoviridae Infections

Summary: this study is designed to generate clinical data as outlined in the note for guidance on harmonization requirements for influenza vaccine marketing authorization by the european medicines agency. the objectives of the trial are: * to evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine northern hemisphere 2006-2007 formulation with the requirements of the european medicines agency * to describe the safety of the inactivated, split-virion influenza vaccine, northern hemisphere 2006-2007 formulation.


Eligibility criteria:
inclusion criteria: * aged at least 18 years on the day of inclusion * informed consent form signed * able to attend all scheduled visits and to comply with all trial procedures * for a woman, inability to bear a child or negative urine pregnancy test at visit 1 * for a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least three weeks after vaccination. exclusion criteria: * febrile illness (oral temperature \>=37.5°c) on the day of vaccination * breast-feeding * participation in another clinical trial in the four weeks preceding the trial vaccination * planned participation in another clinical trial during the present trial period * congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroids therapy * systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances * chronic illness at a stage that could interfere with trial conduct or completion * current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures * blood or blood-derived products received in the past three months * any vaccination in the four weeks preceding the trial vaccination * vaccination planned in the three weeks following the trial vaccination * vaccination against influenza in the previous six months * thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination * subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent

Keywords: influenza orthomyxoviridae infections orthomyxoviruses split-virion influenza vaccine
a trial between the intra-articular local anesthetic infiltration with catheter and interscalene block with catheter in postoperative analgesia after shoulder prosthesis

Conditions: Osteoarthritis

Summary: the control of perioperative pain is necessary to avoid worst surgical suites after shoulder arthroplasty. interscalene block (isb) with or without catheter is the gold standard in postoperative analgesia after shoulder prosthesis but neurological or respiratory adverse events can occured . the intra-articular local (ial) anesthetic infiltration with catheter is a simple procedure. its efficacy was proved in knee and hip arthroplasty but not in shoulder arthroplasty. our hypothesis was the ial is as effective as isb in early postoperative analgesia after shoulder arthroplasty.


Eligibility criteria:
inclusion criteria: * shoulder arthroplasty * osteoarthritis * consent exclusion criteria: * previous surgery in the same shoulder

Keywords: shoulder arthroplasty
a study to compare the pharmacokinetics and safety of current factor viii concentrate and optivate® in haemophilia a.

Conditions: Von Willebrand Disease

Summary: the main objective of the study is to compare the pharmacokinetics of optivate® with the subject's current fviii concentrate when given as a bolus dose of 50iu/kg. the secondary objective is to compare the first and second pharmacokinetic assessments on optivate® (and recovery if a subject changes batch) to evaluate optivate® in terms of clinical tolerance and safety.


Eligibility criteria:
inclusion criteria: * previously treated subjects with severe haemophilia a (\<2% basal fviii activity) without inhibitor to factor viii, at least 12 years of age, currently receiving fviii concentrate and with more than 20 exposure days. exclusion criteria: -
endothelial dysfunction and non-cardiac surgery

Conditions: Surgery; Cardiac Death; Stroke; Myocardial Injury

Summary: endothelial dysfunction is a cardiovascular disease hallmark. after non-cardiac surgery, cardiovascular events correlate with surgical outcomes. understanding the role of endothelial function in these events is crucial. this research aims to study endothelial function and its association with cardiovascular events.

to study the presence of endothelial damage and its association with cardiac events, the investigators will perform an observational study to evaluate flow-induced dilatation of the brachial artery in patients scheduled for non-cardiac surgery. after ethical review board approval, the investigators will select 200 patients admitted for non-cardiac surgery. after the patient written consent, the investigators will perform an ultrasound evaluation of the brachial artery flow-mediated dilatation. this will be performed before, during, and after surgery. a basal troponin level will be obtained and repeatedly measured in the three days after surgery. the investigators will observe clinical outcomes one, 3, and 6 months after the hospitalization. to observe 8% of events, for a 5% alpha and 80% power, 161 patients are needed for our study. the authors considered that to account for a loss of 10% of patients, a sample of 177 patients will be required. considering no national or local incidence of cardiovascular events, we aim to complete a 200-patient selection.

Eligibility criteria:
inclusion criteria: * signed informed consent * patients 45 years or older exclusion criteria: * refuse to participate in the study * myocardial injury or acute myocardial infarction less than two weeks ago * patients who expect less than 2 days of hospitalization * patients in whom the troponin elevation is attributed to a secondary cause (for example, sepsis, pulmonary thromboembolism, electrical cardioversion, etc.) * use of chemotherapy less than 2 weeks ago

Keywords: fmd flow-mediated dilatation troponin
cortisol levels on menopausal symptoms - ancillary (addendum) study to protocol 16997

Conditions: Menopause

Summary: this is an ancillary study to protocol 16997 to examine the stress hormone level in women with menopausal symptoms. this ancillary project will collect additional data from the 45 subjects enrolled in protocol 16997 (no subjects have enrolled in protocol 16997 so far). this study protocol differs from the main protocol (16997) because it will include an acth (hormone) stimulation test which will assess the functioning of stress response in the subjects at entry and exit. subjects will undergo the acth test for this ancillary protocol in the morning when they complete 24-hour urine collection for protocol 16997. the acth (hormone) stimulation test will not be done in the main protocol 16997. during the acth test an iv will be placed in subjects arms, 25ml of blood will be drawn at -30 minutes and 6ml of blood will be drawn at -15 minutes and 0 minutes respectively. following, 0.25mg of acth will be injected intravenous over 60 seconds, and a final 12ml of blood will be drawn 60 minutes later. that is, a total of 50ml of blood will be drawn to test serum blood hormone levels from the subjects during the acth (hormone) stimulation test. the 24 hour cortisol data collected in the main protocol 16997 will be used for this study analysis. when subjects are consented for protocol 16997, they will also be consented for this ancillary study. in addition to the consent visit, subjects will have two study specific visits (entry and exit) for this ancillary study. the pi will schedule the specific visits for this study to be in conjunction with those scheduled for protocol 16997. there is no collaborations with other sites in the ancillary study.


Eligibility criteria:
inclusion criteria: 1. women with menopausal vms bothersome enough to warrant treatment; 2. minimum of 7 hot flashes per day (on average); 3. age limits: women ages 40-70 who have had at least one missed menstrual cycle or have undergone spontaneous menopause, women of any age who have medically induced menopause, women of any age who have had oophorectomy; 4. informed written consent; 5. ability to follow treatment protocols. exclusion criteria: exclusion criteria (cohort) 1. concomitant illness with reasonable likelihood of limiting survival to less than one year; 2. current substance abuse (alcohol or drug); 3. pregnancy known, suspected or planned in next year. exclusion criteria (ta intervention) 1. other concomitant menopause treatment; 2. participating in acupuncture treatment or formal psychological stress management program within the last year; 3. participating in another treatment for vms, unless willing to stop it 4 weeks in advance of participation; 4. hiv infection, chronic or active hepatitis or other blood-borne illness.

Keywords: menopause cortisol acth
effect of continuous versus cyclic daytime enteral nutrition on circadian rhythms in critical illness

Conditions: Critical Illness; Intensive Care Unit; Circadian Rhythm; Sleep; Enteral Nutrition

Summary: disruption of circadian rhythms is frequently observed in patients in the intensive care unit (icu) and is associated with worse clinical outcomes. the icu environment presents weak and conflicting timing cues to the circadian clock, including continuous enteral nutrition. the goal of this clinical trial is to evaluate the effect of timing of enteral nutrition on the circadian rhythm in critically ill patients. patients admitted to the intensive care unit will be allocated to receive either continuous or cyclic daytime (8am to 8 pm) enteral feeding. differences in circadian rhythms will be assessed by 24h patterns in core body temperature, heart rate variability, melatonin and peripheral clock gene expression. secondary outcomes include depth of sleep, glucose variability and incidence of feeding intolerance. this study is expected to contribute to the optimalisation of circadian rhythms in the icu.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * receiving of or intention to start enteral nutrition via nasogastric or nasoduodenal tube * arterial line * expected duration of icu admission \> 48 hours exclusion criteria: * receiving parenteral nutrition * prior night-time (20.00h - 8.00h) enteral tube feeding within the same hospitalization before study inclusion * readmission to icu with prior study inclusion * chronic enteral tube feeding prior to current admission * presence of one or more contraindications of enteral feeding and/or at significant risk for gastrointestinal tolerance according to standard protocol (including but not limited to gastrointestinal haemorrhage, intestinal ischemia or necrosis, impaired digestive tract integrity due to obstruction or perforation, gastrectomy, enterectomy, history of gastroparesis or oesophageal dysmotility or expected surgery within 24 hours) * patients with glycaemic emergency (including but not limited to hyperglycaemic hyperosmolar nonketotic coma, diabetic ketoacidosis, severe hypoglycaemia resulting in icu admission) or patients controlling their glucose levels and insulin dosing via continuous glucose monitoring * expected death within 24 hours * do-not-resuscitate (dnr) order * treatment with extracorporeal membrane oxygenation * severe neurological damage (significant neurological abnormalities such as bleeding, ischemia, neurotrauma or severe encephalopathy with glasgow coma scale ≤ 8) * suspected or confirmed pregnancy

Keywords: randomized controlled trial