Kornimate/medical-research-clean huggingface dataset:
heparin based on ideal body weight for cardiopulmonary bypass in obese patients

Conditions: Cardiac Surgery; Cardiopulmonary Bypass; Obese Patients (BMI ≥ 30 kg/m²)

Summary: the optimal heparin regimen during cardiopulmonary bypass (cpb) has not been well established in obese patients. results of a preview study show that the standard heparin management based on total body weight in obese patients during cpb resulted in excessive heparin level, which could lead to excessive postoperative bleeding. to avoid this overdosing, an initial heparin bolus based on ideal body weight in obese patients was proposed. the main objective of the study is to evaluate the effects of heparin injection, based on ideal body weight, on intraoperative plasma heparin levels and activated coagulation time (act) in a population of obese patients, compared to a group of obese patients undergoing cpb surgery with heparin management based of total body weight. the secondary objectives are to evaluate the relationship between heparin level and act in each group of patients and at different time points during cpb, and to compare the incidence of bleeding, intraoperative transfusions and complications in the two groups of patients.


Eligibility criteria:
inclusion criteria: * obese patients (bmi ≥ 30 kg/m²) * planned cardiac surgery under cardiopulmonary bypass * coronary-artery bypass graft, or valve surgery) * age ≥ 18 yo exclusion criteria: * allergy to heparin * emergency surgical intervention * redo surgery * heart transplantation * surgery for circulatory assistance * pre-operative heparin use
effects of combined rtms and treadmill training in people with parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to investigate whether the beneficial effect of treadmill training on people with parkinson's disease can be enhanced by high- and low-frequency repetitive transcranial magnetic stimulation (rtms).

this is a randomised placebo-controlled trial. fifty-one participants with parkinson's disease (pd) will be recruited from the hong kong pd association, a self-help group and movement disorders clinic of 3 local hospitals. written informed consent in accordance with the declaration of helsinki will be obtained from all participants. eligible participants will be randomly assigned into one of the three groups: 1hz-tt, 25hz-tt, and sham-tt upon recruitment. randomisation will be generated by a computer program and group assignment will be blinded to both participants and assessor. participant will receive either 1-hz, 25-hz, or sham rtms which will last for about 20 minutes followed by 30 minutes treadmill walking training for 12 sessions, 4 times per week for 3 weeks. all assessments will be conducted 1 week before intervention and 1 day after completion of intervention, after 1-month training and at 3-month post training. the sample size calculation is based on the significant findings of the gait speed reported by yang et al (2013). a two-way repeated measures anova design with between-subject group effect (3 levels) and within-subject time effect (4 levels) determines that 15 subjects per group are required to achieve 85% power to test the interaction effect between groups and time effect with a 5% significance level and the effect size is 0.2. by assuming 10% dropout rate, 17 subjects will be required per group.

Eligibility criteria:
inclusion criteria: * diagnosed with idiopathic parkinson's disease by a neurologist * had been stable on anti-parkinsonian medication * able to walk independently for 30 meters exclusion criteria: * severe co-morbidity that may interfere with their ability to participate including significant orthopaedic or rheumatological conditions or disorders of peripheral nervous systems that may interfere with mobility or balance performance * a diagnosis of neurological disease other than pd * a history of psychiatric disorders * the impossibility of inducing motor evoked potentials (meps) * a score of less than 24 on the mini-mental state examination * contraindication to tms including personal or family history of seizure disorder, metal in the head, implants of medical devices such as cardiac pacemakers or medical pumps, females subjects who are pregnant, a history of neurosurgery * subjects with irrepressible tremor and / or dyskinesia

Keywords: transcranial magnetic stimulation metaplasticity gait training
multidisciplinary ambulatory intervention program in family of children and adolescents with obesity

Conditions: Obesity

Summary: obesity has become a pandemic, and it is today's principal neglected public health problem. obesity has increased dramatically during the past two decades at adolescence, it is an aggravating issue, because obesity tends to persist in adulthood and the longer its duration, the higher the associated mortality and morbidity. obesity imposes a heavy health and social burden, and it is widely recognized that treatment is costly. if obesity is not successfully addressed by late adolescence, the likelihood of weight loss in adulthood is as low as 5%. therefore, prevention is crucial, and children and adolescents should be a priority target. treatment of obesity is costly, time consuming, difficult and the results aren't always satisfying on most cases the patients receive dietary advice only (6-10 visits per year). and usually the patients end the treatment early due to lack of results. the best treatment of children and adolescent obesity is done in highly specialized settings, by a multidisciplinary team. those programs have a limited number of locations (not always in proximity to the patients' residence), in addition, they are long term treatments and therefore are hard to complete successfully without additional support, therefore only a limited number of patients can benefit from such programs. due to the reasons mentioned above, many families tend not to start the process of treating their obese child, or turn to commercial weight loss programs, or put their children according to their beliefs and diets. therefore ambulatory medicine is the ideal setting for the treatment of children and adolescent's obesity, it's also in proximity to the patients' residence, the medical team has a deep knowing of their patients and the possibility for long term maintenance and follow-up. we propose a trial of obesity treatment by behavior modification program, including parents as agents of change.


Eligibility criteria:
inclusion criteria:children (6-18 years) with bmi in the 85th to 95th percentile or higher exclusion criteria:children with chronic diseases treated with chronic medications. refuse to participate in to the study

Keywords: intervention program diet physical activity adolescents obesity
predictive factors of clinical response to ustekinumab in active crohn's disease

Conditions: Crohn Disease

Summary: ustekinumab is a fully human immune globulin gk (iggk) monoclonal antibody against the common p40 subunit of interleukin-12 and interleukin-23, which are implicated in the pathogenesis of inflammatory bowel disease. its efficiency to induce and maintain clinical response in patients with anti tnf resistant crohn's disease has been proved in several clinical trials, and the profile of safety of this treatment was good, but the investigators have few data about biological characteristics of patients treated by ustekinumab, particularly about ustekinumab through levels and rate of patients developing anti ustekinumab antibodies during the induction and maintenance stages, and no predictive factors of clinical response have been identified yet. the aim of this study will be to assess the evolution of biological markers of inflammation and ustekinumab trough levels and antibodies, in responders and non responders patients treated by ustekinumab, in order to identify predictive factors of clinical response. the investigators will perform a prospective observational study, including the patients followed in the university hospital center of lyon and treated by ustekinumab for a moderate to severe crohn's disease (with a hbi score≥4 ). all the patients included will have been previously treated by at least one anti tnf and/or vedolizumab, with specified criteria for a primary non response, a secondary loss of response or unacceptable side effects. then, clinical and biological data will be collected for each patient at the inclusion, and then at weeks 4, 8, 16, 24: hbi score, sides effects, extra intestinal manifestations, steroids withdraw, crp, calprotectin, ustekinumab trough levels and ustekinumab antibodies. the investigators will compare responding and non responding patients at week 16 (end of the induction period) according to these data. the hypothesis the investigators state is that an early and significant decrease of the inflammation markers in blood and stools associated with a high ustekinumab through level in blood is associated with a clinical response at week 16 in the patients treated by ustekinumab


Eligibility criteria:
inclusion criteria: * age \> 18 years old * man or non pregnant woman * diagnostic attested of crohn's disease * active crohn's disease, with hbi score ≥ 4 * previous treatment by at least one anti tnf and / or vedolizumab,, with primary non response, secondary loss of response or unacceptable side effects * formal indication of treatment by ustekinumab * patient informed and not opposed to his participation at the study exclusion criteria: * pregnancy * evolutive cancer * evolutive and uncontrolled infection * psychiatric pathology that could interfere with the follow-up * refusal of the patient

Keywords: crohn disease ustekinumab vedolizumab anti-tnf crp calprotectin cohort
efficacy of tenofovir disoproxil on mother-to-child transmission of hbv in tokombéré, cameroon in pregnant women

Conditions: Hepatitis B Virus - Chronic Active

Summary: iin this study, pregnant women with hbeag-positive viral hepatitis b or high viral load will receive tenofovir disoproxil fumarate from the 28th week of amenorrhoea until 6 weeks after delivery. their newborns will receive the hepatitis b vaccine, starting with one dose at birth and followed by three booster doses, according to the expanded programme on immunisation. the investigators hypothesise that a short course of tdf could greatly reduce the risk of hbv mtct in pregnant women at high risk of mtct (hbeag positive or with high viral load).

this is a prospective, single-arm, open-label, descriptive, phase iv clinical trial in hbsag and hbeag positive pregnant women. eligible pregnant women will receive 245 mg of tenofovir disoproxil fumarate once daily from 28 weeks of pregnancy until 6 weeks after delivery. newborns will receive the hepatitis b vaccine, starting with one dose at birth, followed by three booster doses, in accordance with the expanded programme of vaccination. the study aims to show that the addition of maternal antiviral treatment to vaccination at birth followed by three booster doses can be favourably considered in the context where vaccination alone is not sufficient to prevent transmission of the hepatitis b virus from mother to child. a total of 150 pregnant women will be included in the tokombéré district.

Eligibility criteria:
inclusion criteria: * pregnant women with a term of less than 24 weeks of amenorrhea; * hbsag positive ; * hbeag positive or hbeag negative with a high viral load ( \> 200 000 ui/ml) ; * 16 years old or more on the inclusion day ; * signature of free and informed consent (for pregnant women aged 16 to 21, the participant's consent as well as the authorization of a parent/adult husband/ legal tutor will be collected) which also includes consent for the children exclusion criteria : * hiv co-infection; * women treated for hbv; * creatinine clearance \<30 ml / min; * suspicion of poor monitoring of children's vaccination schedule for hbv (vaccination at birth + boosters); * disease or treatment contraindicating the taking of tdf.
l-arginine, vascular response and mechanisms

Conditions: Hypertension; Diabetes

Summary: the purpose of the study is to employ the supplement l-arginine to test the hypothesis that activation of blood flow to the brain during cognitive tasks is regulated by nitric oxide in older subjects with diabetes mellitus and/or hypertension (high blood pressure).


Eligibility criteria:
inclusion criteria: * diabetes and/or hypertension exclusion criteria: * alzheimers disease, dementia, stroke, active herpes, recent angina or heart attack
prismaflex hf20 set and prismaflex® system 7.10/7.20 for acute continuous renal replacement therapy (crrt) in children

Conditions: Acute Kidney Injury in Pediatric Patients

Summary: the primary objective of this study is to evaluate the efficacy of the gambro prismaflex® hf20 set based on testing the hypothesis that it delivers sufficient renal replacement therapy to effectively treat acute kidney injury (aki) in pediatric patients by reducing blood urea nitrogen (bun).


Eligibility criteria:
inclusion criteria: 1. patients with a hospital admission body weight ≥8 and \<20 kg (ie, ≥17.6 and \<44.09 lbs). 2. patients with aki defined as either 1) aki by the kidney disease improving global outcomes (kdigo) acute kidney injury guideline serum creatinine criteria, which is a \>50% rise in serum creatinine over baseline or a 0.3 mg/dl scr rise in 48 hours or 2) as aki by the pediatric modified risk, injury, failure, loss, end-stage renal disease (prifle) criteria which is a 25% reduction in estimated creatinine clearance,16 or 3) a serum creatinine \>1.2 mg/dl. or patients with severe fluid overload, defined as a \>10% fluid accumulation relative to the icu admission. 3. patients who have received rrt previously can be included in the study if \>24 hours have elapsed since their previous rrt treatment. 4. provide written informed consent from one or both parents, as required by the local irb or legal guardians, unless one parent is deceased, unknown, incompetent or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child per 21 cfr part 50.55(e). exclusion criteria: 1. patients a) weighing 8.0-20.0 kg with a hemoglobin of \<7.0 g/dl, b) weighing 8.0-12.0 kg with a hemoglobin of \<8.0 g/dl (unless blood prime used), and c) weighing 12.1-20.0 kg with a hemoglobin of \<7.5 g/dl (unless blood prime used). 2. children who are wards of the state.

Keywords: acute kidney injury continuous renal replacement therapy blood urea nitrogen (bun) prismaflex pediatric
subcutaneous versus intravenous morphine when switching from oral to parenteral route in palliative cancer patients

Conditions: Pain Cancer

Summary: the investigators aim to establish whether the intravenous or the subcutaneous route of administration has clinically significant advantages when parenteral administration of morphine is started with a combination of continuous infusion and bolus doses in palliative cancer patients. patients admitted to a hospital palliative medicine unit with an indication for parenteral administration of morphine will be recruited. the patients will have two similar infusion pumps with continuous infusion and bolus function. one infusion pump will be connected to an intravenous line, the other to a subcutaneous line. one pump contains morphine, one placebo. the primary endpoint is the time from initiation of infusion with titration to the final infusion rate that provides pain control is reached.

intravenous administration has theoretical advantages in more predictable pharmacokinetics and shorter time to maximum effect. subcutaneous administration is less invasive, requires less specialized personnel and equipment, and probably poses a lower risk of complications than an intravenous line. traditionally the subcutaneous route has been the recommended first choice for parenteral administration of opioids for palliative cancer patients. the investigators aim to establish whether the intravenous or the subcutaneous route of administration has clinically significant advantages when parenteral administration of morphine is started with a combination of continuous infusion and bolus doses in palliative cancer patients. patients admitted to a hospital palliative medicine unit with an indication for parenteral administration of morphine will be recruited. the patients will have two similar infusion pumps with continuous infusion and bolus function. one infusion pump will be connected to an intravenous line, the other to a subcutaneous line. one pump contains morphine, one placebo. the primary endpoint is the time from initiation of infusion with titration to the final infusion rate that provides pain control is reached. secondary endpoints are time from bolus administration to pain relief, comparison of tmax, cmax, and size of auc0-60 after bolus doses, the number of bolus doses first 24 and 48 hours, and the number of patients reaching acceptable pain relief within 48 hours.

Eligibility criteria:
inclusion criteria: * unsatisfactory pain control despite titration of oral or transdermal opioids * planned discharge to home or nursing home exclusion criteria: * estimated survival time \<2 weeks * a clear indication for either intravenous or subcutaneous administration * patient unable to report patient reported outcomes needed in the study due to language barriers or cognitive impairment * impossible to establish venous access
the effect of a resistance training program in healthcare workers on pain, workability and physical function.

Conditions: Musculoskeletal Pain; Physical Function; Work Ability

Summary: the prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence. on the other hand, physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend. thus, it seems relevant to perform a brief intervention. this study is intended to investigate the difference between the effect of workplace-based physical exercise (using elastic bands and body weight exercises) and a group control on musculoskeletal pain, physical exertion during work, physical function, need for recovery, self-rated use of analgesics, and work ability among healthcare workers.


Eligibility criteria:
inclusion criteria: * healthcare workers at the hospital * informed consent exclusion criteria: * unable to perform exercises
high dose of quetiapine in treating subjects with treatment refractory schizophrenia or schizoaffective disorder

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this study will investigate the safety and efficacy of quetiapine in sub-optimally responding patients with dsm-iv schizophrenia using a double blind, randomized 12-week trial comparing oral doses of 1200 mg/d to 600 mg/d of quetiapine.

the study will be conducted at two sites: manhattan psychiatric center (mpc), and the clinical research and evaluation facility at the nathan s. kline institute for psychiatric research/rockland psychiatric center (nki). a total of 60 patients will be enrolled, 30 at each location. after a screening period of 1 week, all patients will be entering an open label, four-week quetiapine treatment period (run-in phase), during which quetiapine will be titrated to 600 mg po daily and other adjunctive antipsychotics will be gradually tapered and discontinued. other concomitant medications such as mood stabilizers will be maintained, if their dose has been stable for the preceding 2 months. patients not responding to quetiapine treatment at 600 mg po (defined as reduction of \< 15% change in positive and negative syndrome scale (panss) total score between start of run-in to end of week 4) during the run-in phase, will be eligible to enter the double blind phase. study baseline will be day 7 of week 4 of the run-in phase. patients qualifying for the double-blind phase will be randomly assigned to either high dose 1200 mg quetiapine daily (group a) or to 600 mg quetiapine (group b) daily and treated on the assigned dose in a double blind fashion for 8 weeks (week 1 through week 8 of double blind phase). measures of extra-pyramidal side effects, psychopathology, and safety will be conducted throughout the trial.

Eligibility criteria:
inclusion criteria: 1. dsm-iv criteria for chronic schizophrenia or schizoaffective disorder 2. sub-optimal treatment-response 3. total score \> 60 on the positive and negative syndrome scale (panss) at baseline of run-in phase and again at baseline of double blind phase 4. age 18-64 years old 5. signed informed consent 6. patient is in good general medical health exclusion criteria: 1. history of failure to respond to 400 mg/day or more of clozapine for 8 contiguous weeks 2. history of failure to respond to quetiapine treatment at dosages \> 1200 mg daily for 6 contiguous weeks 3. history of quetiapine intolerance (e.g., clinically significant leukopenia or agranulocytosis, or severe dystonic reactions) 4. significant recent history of violence or suicidal activity, which required \> 4 episodes of prn anti-agitation medication per week 5. mental retardation 6. depot antipsychotic within 30 days before randomization 7. significant medical illness requiring frequent dose adjustment or medication changes clozapine non-responders are explicitly excluded, as they would be unlikely to show a response in this study.

Keywords: schizophrenia quetiapine schizoaffective disorder
lippia alba for migraine prophylaxis and treatment

Conditions: Migraine Disorders

Summary: abstract background: there is no universally accepted and effective prophylaxis of migraine headache episodes. thus the investigators aimed to investigate the effects of lippia alba (mill.) n. e. brown, an herb with many effects on central nervous system, on pain frequency and intensity of migraine patients. methods: patients were enrolled in a prospective, phase 2, non-controlled cohort study to orally receive ethanolic extract of l. alba leaves (1-2 drips/kg/day). headache intensity and frequency of episodes were recorded before and after 30-60 days of treatment. the investigators also studied the chemical composition of its essential oil by gas chromatography-mass spectrometry. results: the investigators described for the first time a particular l. alba chemotype with geranial and carvenone as major compounds. with treatment, both frequency and intensity of pain episodes significantly decreased from baseline to first reassessment date. more than 80% of patients experienced a minimum 50% reduction on pain intensity and frequency. no side effects were reported. conclusions: treatment with a geranial plus carvenone chemotype of l. alba ethanolic extract is a cheap, widely available, highly effective therapy to reduce both the intensity and the frequency of headache episodes of migraine patients with no side effects. keywords: headache, migraine, medicinal plant, essential oil, phytotherapy


Eligibility criteria:
inclusion criteria: * migraine diagnostic exclusion criteria: * patient's request

Keywords: headache migraine medicinal plant essential oil phytotherapy