Kornimate/medical-research-clean huggingface dataset:
dosing obese with noxafil® under a trial (donut)

Conditions: Morbid Obesity

Summary: although posaconazole is approved for the prophylaxes and treatment of invasive fungal infections, specific dosing guidelines for posaconazole in (morbidly) obese patients are not specified. there is clear evidence indicating that heavier patients are receiving a sub-optimal dose if the current guidelines are used. specifically in the setting of augmented prevalence of species with intermediate susceptible to posaconazole, adequate dosing is needed at start of treatment. therefore it seems prudent to conduct a trial in a cohort of obese patients who receive posaconazole (300mg or 400mg) and define the pharmacokinetics. these will then be compared to the pharmacokinetics in a normal-weight group receiving 300mg posaconazole.

obese patients with a bmi ≥ 35 kg/m2 undergoing endoscopic gastric bypass surgery will receive a 300 mg or 400mg dose of posaconazole. a pk curve will be determined after administration at t=0.45, 0.75, 1, 1.5, 2, 4, 8, 12, 24, and (if feasible) 48 hours post infusion. blood samples (4 ml) on pk days will be taken to obtain at least 2.0 ml of plasma.

Eligibility criteria:
inclusion criteria: 1. subjects bmi: * obese groups: subject must have a bmi ≥35 kg/m2 at the time of inclusion, * non-obese group: subject must have a bmi ≥18.5 and \< 25kg/m2 at the time of inclusion. 2. subject is at least 18 of age on the day of screening and not older than 65 years of age on the day of dosing; 3. if a woman, is neither pregnant nor able to become pregnant and is not nursing an infant; 4. subject is able and willing to sign the informed consent before screening evaluations. for the non-obese subjects the following additional inclusion criteria applies: 5. subject is in good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry, hematology and urinalysis testing within 6 weeks prior to study drug administration. results of biochemistry, hematology and urinalysis testing should be within the laboratory's reference ranges (see appendix a). if laboratory results are not within the reference ranges, the subject is included based on the investigator's judgment that the observed deviations are not clinically relevant. this should be clearly recorded; exclusion criteria: 1. documented history of sensitivity to medicinal products or excipients similar to those found in the posaconazole preparation; 2. history of, or known abuse of drugs, alcohol or solvents (up until a maximum of three months before study drug administration); 3. use of medication that has known relevant interaction with study drug as determined by the investigator up to 1 weeks prior to study drug administration. 4. donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks prior to study drug administration; 5. blood transfusion within 8 weeks prior to study drug administration;
clozapine champion-echo educational study to improve clozapine use.

Conditions: Schizophrenia Schizoaffective

Summary: in a randomized controlled design with approximately 26 biweekly sessions over 12 months, the investigators propose to test the effectiveness of an echo-based intervention for improving the use of clozapine in people eligible for clozapine. the sessions will include: 1) active dissemination of knowledge and information by an expert "hub" followed by 2) clozapine case presentations and vignettes submitted by the "spokes". this intervention, clozapine champion-echo (center for help and assistance for maryland prescribers- improving outcomes network using extension for community healthcare outcomes, will be referred to as "champion" throughout.. to minimize anc monitoring barriers and maximize recruitment, the investigators will provide food and drug administration (fda)-cleared anc point of care (poc) monitoring devices to all study sites, including those in the control condition. the investigators will enroll at least 300 prescribers and additional clinical team members (up to 300) from 60 outpatient mental health clinics (omhcs) and other treatment sites; approximately half the ohmcs will be randomized to champion and half randomized to enhanced treatment as usual (etau).


Eligibility criteria:
inclusion criteria: * located at a site in the state of maryland with at least 3 prescribers at the site. * prescribers/clinical team should be licensed in the state of maryland and have prescribed antipsychotics previously. * between the ages of 22 and 85 years old * willing to participate in pre- and post-testing * willing to agree to try to participate in the champion sessions exclusion criteria: * not willing to participate in champion sessions
drug therapy for generalized anxiety disorder among the elderly

Conditions: Anxiety Disorders; Generalized Anxiety Disorder

Summary: this study will determine the efficacy of escitalopram (lexapro®), an anti-anxiety drug, for generalized anxiety disorder (gad) and the ways genetics affect response to treatment for gad in elderly individuals.

gad is a serious public health issue; particularly among the elderly, prevalence of the condition is high, and functional burden on those with the illness is significant. gad is associated with irregular levels of neurotransmitters, chemicals that carry messages across nerve endings. serotonin is a neurotransmitter that helps regulate mood and emotions; increased levels of serotonin have been shown to reduce anxiety. standard treatment for gad typically involves selective serotonin reuptake inhibitors (ssris), drugs that reduce serotonin re-entry into nerve cells. escitalopram is an ssri that is well tolerated and highly specific for the serotonin transporter (sert). the primary aim of this study is to examine the efficacy of escitalopram in reducing anxiety symptoms among elderly gad patients. additional aims include examining the efficacy of escitalopram for improving function, quality of life, and neuropsychological functioning, and examining whether genetic variation in the sert gene influences these participants' response to treatment. participants will be randomly assigned to receive either escitalopram or placebo for 12 weeks (there is also a 12 week open label extension in which all participants will receive escitalopram). participants will have weekly/biweekly study visits; during these visits, participants will complete self-report questionnaires on functional ability and anxiety symptoms. blood collection and cognitive testing through various tasks will also occur.

Eligibility criteria:
inclusion criteria: * diagnosis of at least moderately severe generalized anxiety disorder (gad) exclusion criteria: * serious suicide risk or psychiatric instability that would affect study participation * dementia * substance abuse, such as alcoholism, within 6 months prior to study entry * diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or bipolar disorder * unstable medical conditions that would preclude the use of escitalopram * use of certain psychotropics that can not be safely tapered or discontinued for at least 2 weeks prior to and during the study * use of neuroleptics that are absorbed over a prolonged period of time within 6 weeks prior to study entry

Keywords: anxiety elderly aged serotonin reuptake inhibitors ssri sert
safety and efficacy of ledipasvir/sofosbuvir fixed-dose combination ± ribavirin in treatment-experienced subjects with genotype 1 hcv infection

Conditions: Chronic Hepatitis C Virus

Summary: this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (fdc) with or without ribavirin (rbv) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 hepatitis c virus (hcv) infection.


Eligibility criteria:
inclusion criteria: * age \> 18, with chronic genotype 1 hcv infection * hcv treatment-experienced, including patients who have previously failed a nonstructural protein (ns)3/4a protease inhibitor plus pegylated interferon (peg)/rbv regimen * hcv rna \> 10,000 iu/ml at screening * cirrhosis determination; a liver biopsy may be required * screening laboratory values within defined thresholds * use of two effective contraception methods if female of childbearing potential or sexually active male exclusion criteria: * pregnant or nursing female or male with pregnant female partner * coinfection with hiv or hepatitis b virus * current or prior history of clinical hepatic decompensation * hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers) * chronic use of systemic immunosuppressive agents * history of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

Keywords: hcv genotype 1 (gt-1) hcv sustained virologic response direct acting antiviral combination therapy gs-7977 gs-5885 ribavirin open label sofosbuvir additional relevant mesh terms: hepatitis hepatitis, chronic hepatitis c hepatitis c, chronic liver diseases digestive system diseases hepatitis, viral, human virus diseases enterovirus infections picornaviridae infections rna virus infections flaviviridae infections antiviral agents anti-infective agents therapeutic uses pharmacologic actions antimetabolites molecular mechanisms of pharmacological action
effects of neuromuscular pelvic realigning exercises on pelvic floor muscle function in continent subjects

Conditions: Pelvic Floor Muscle Weakness; Stress Urinary Incontinence; Pelvic Asymmetry

Summary: the goal of this research study is to investigate the effect of a new neuromuscular approach for correcting pelvic alignment and improving pelvic floor muscle function. investigators hypothesized that this approach would be significantly superior than no intervention to improve the ability of pelvic floor muscle contraction, measured by transabdominal sonography as bladder base elevation. participants will be randomized to the intervention and control groups. while intervention group will receive five supervised sessions of pelvic realigning exercises, the control group will receive no intervention. bladder base elevation will be measured as an indicator of pelvic floor muscle function, before and after one week intervention in both control and intervention groups.


Eligibility criteria:
inclusion criteria: positive ober's test exclusion criteria: * pelvic/low back pain in previous 12 months
effects of sodium bicarbonate supplementation on intermittent and intense task

Conditions: Sodium Bicarbonate; Alkalosis, Metabolic; Electromyography; Fatigue

Summary: the aim of this study was to verify if sodium bicarbonate (nahco3) suplementation promotes changes in the performance, muscular activity and strength of individuals trained during the intermittent and intense task . twelve trained adult men will participate in this randomized, double-blind, crossover clinical trial. each participant should receive two types of intervention with a 14-day interval between conditions: alkalosis (alk) in which gelatinous capsules containing 0.3 g.kg -1 of nahco 3 and placebo (pla) are administered, in which 0.3 g.kg-1 of calcium carbonate (caco3). the following results will be considered: electromyographic activity (emg) of the quadriceps muscle, peak torque, ph, lactate, and perception of effort, recovery and pain questionnaires, which will be collected during intermittent and high intensity di protocol. anova of repeated measures will be used to verify possible differences between groups.


Eligibility criteria:
inclusion criteria: * resistance trained men (minimum 12 moths resistance training experience) exclusion criteria: * diabetes mellitus; * respiratory (asthma, copd), renal, metabolic, rheumatic and cardiovascular disorders; * acid-base balance disorder; * continuous use of some type of medication; * use of high-protein supplementation and creatine supplementation; * users of anabolic steroids.
phase i-ii vaccination of autologous dendritic cells transduced with adenoviral vector encoding ns3 in hepatitis c encoding ns3 in hepatitis c

Conditions: Hepatitis C, Chronic

Summary: dendritic cells (dc) play a central role in the activation of t-cell responses and have shown to be very immunogenic in preclinical in vivo and in vitro assays. the aims of this study is to assess the efficacy of therapeutic vaccination pilot clinical trial in genotype 1 hcv patients using autologous dc transduced with a recombinant adenovirus encoding ns3


Eligibility criteria:
inclusion criteria: chronic hepatitis c (genotype 1b) that had previously failed interferon/ribavirin-based treatment exclusion criteria: liver cirrhosis hbv-coinfection bilirubin \>1.5 times uln or alt \>7 uln hepatocellular carcinoma immunodeficiency
efficacy and safety of indacaterol in patients with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: • male or female patients aged 40 years or over with moderate to severe chronic obstructive pulmonary disease (copd) plus * 20 pack-year smoking history * signed informed consent * post-bronchodilator forced expiratory volume in 1 second )fev1) ≥ 30% and \< 80% predicted fev1/fvc (forced vital capacity) \< 70% exclusion criteria include: * history of asthma * prior exposure to indacaterol * active cancer or history of cancer * patients with concomitant pulmonary disease * patients with diabetes type i or uncontrolled diabetes type ii * patients with a history of long qt syndrome or whose qtc interval (bazett's) measured at screening or randomization is prolonged * patients unable to successfully use a dry-powder inhaler device or perform spirometry measurements other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: chronic obstructive pulmonary disease copd indacaterol
the impact of daily intake of short-chain fatty acids on cardiometabolic risk factors in individuals at risk for metabolic syndrome

Conditions: Energy Expenditure; Metabolic Syndrome; Anthropometry; Body Composition; Glycemia; Lipaemia; Metabolomics; Blood Pressure

Summary: during this study, the effect of short-chain fatty acids on blood lipaedemia, glycemia, anthropometrics, blood pressure and energy expenditure will be investigated.

the goal of this study is to investigate the impact of consuming every day a drink enriched with short-chain fatty acids for 12 weeks on the cardiometabolic health in individuals at risk of metabolic syndrome. this means the investigators are looking for people with overweight and disrupted cholesterol, high blood pressure or elevated blood glucose. the individuals will consume for 12 weeks a drink either enriched with scfa or a control drink (randomly allocated). before and after this period (study visit 1 and 4), a study visit will take place in which metabolic parameters will be measured such as blood pressure, body weight, waist- and hip circumference, body composition, energy expenditure, glucose, insulin and blood lipids. after 4 and 8 weeks, anthropometrics, blood pressure and body composition will be measured during a short study visit (study visit 2 and 3).

Eligibility criteria:
inclusion criteria: * male and female participants * central obesity ( bmi ≥ 25 kg/m² or waist circumference ≥ 80 cm for women/ ≥ 94 cm for men) * one additional risk factor for metabolic syndrome: 1. insulin resistance (homa-ir ≥ 1.7 or fasting glucose ≥ 100 mg/dl) 2. triglyceride concentration ≥ 150 mg/dl 3. hdl-cholesterol \< 40 mg/dl for women/ \< 50 mg/dl for men 4. systolic blood pressure ≥ 130 mmhg or diastolic blood pressure ≥ 85 mmhg * knowledge of english exclusion criteria: * gastrointestinal disorders such as ibd, ibs, celiac disease, chronic constipation, chronic diarrhoea * history of abdominal surgery, except for appendectomy * use of antihypertensive, cholesterol lowering, glucose-regulating drugs and corticosteroids * use of antibiotics 3 months prior to the start or during the study * use of probiotics and prebiotics 2 weeks prior to the start of the study/ during the study * being on weight loss, gluten-free, lactose-free or vegan diet * pregnancy, lactation or wish to become pregnant * previous or current substance/ alcohol dependence or abuse * hyper- or hypothyroidism * allergy or intolerance to oat milk

Keywords: short-chain fatty acids cardiometabolic health
thoracic paravertebral blockade in video assisted thoracoscopic surgery (vats)

Conditions: Pain, Postoperative

Summary: video-assisted thoracoscopic surgeries (vats) include severe postoperative acute pain which is also a predictor of chronic pain. in this study, the investigators aim to compare the postoperative effects of thoracic paravertebral block (tpvb) and intravenous patient controlled analgesia (pca) on the prevention of chronic pain of patients undergoing vats.

video-assisted thoracoscopic surgeries (vats) include significant postoperative acute and chronic pain because of trocar site tissue damages, intercostal nerve injuries and related inflammatory responses. poorly controlled pain in the early postoperative period usually causes chronic pain, and also affects patients' physiotherapy, mobilization and daily function. our hypothesis in this study is 'thoracic paravertebral block (tpvb) is associated with an improvement in control of acute and chronic pain after vats compared to systemic analgesia.

Eligibility criteria:
inclusion criteria: asa i-iii patients who undergo video-assisted thoracoscopic surgery (vats) under ga exclusion criteria: patients with difficult understanding the instructions for using pca and/or pain scales patients with contraindication to regional anesthesia patients with significant neurologic, psychiatric or cognitive disorders history of substance abuse or chronic opioid use

Keywords: thoracic paravertebral block patient controlled analgesia video assisted thoracoscopic surgery postoperative acute pain chronic pain
medial vs lateral approach for total knee replacement on valgus knee: a randomized clinical trial

Conditions: Osteoarthritis

Summary: the most common surgical approach to perform a total knee replacement is called medial parapatellar approach. it's effective and can be applied virtually to all types of knee deformities. the keblish approach is an alternative approach which uses the lateral side of the patella to enter the joint. some orthopaedic surgeons consider the latter approach a better option when facing a valgus deformity of the osteoarthritic knee but there is no convincing evidence on the literature supporting one or another approach. the objective of this study is to compare the medial vs lateral approach for total knee replacement on valgus knee.

total knee replacement is a procedure for the treatment of advanced knee osteoarthritis. the most common surgical approach to perform a total knee replacement is called medial parapatellar approach, or simply medial approach. it's effective and can be applied virtually to all types of knee deformities. the keblish approach is an alternative approach which uses the lateral side of the patella to enter the joint. it's also called lateral parapatellar approach. some orthopaedic surgeons consider the latter approach a better option when facing a valgus deformity of the osteoarthritic knee. theoretically, the keblish approach can promote better soft tissue balance and patellar tracking, but there is no convincing evidence on the literature supporting one or another approach for a total knee replacement on valgus knee. the objective of this prospective and randomized clinical trial is to compare the medial vs lateral approach for total knee replacement on valgus knee.

Eligibility criteria:
inclusion criteria: * severe osteoarthritis (kellgren \& lawrence grade 4) * valgus deformity of the knee * read and sign the informed consent form exclusion criteria: * severe pain in other joint (vas\>6) * comorbidities or any condition that contraindicate the procedure * previous arthroplasty on the index knee

Keywords: osteoarthritis knee arthroplasty replacement
anesthetic & surgical protocol for emergency surgeries during the era of covid-19

Conditions: COVID-19

Summary: a protocol applied during anesthesia and surgical interventions for patients with emergency surgical conditions during the era of covid-19 disease

all covid-19 patients who were admitted to emergency departments presenting with emergency surgical conditions were evaluated for assurance of having covid-19 disease. then, the appropriate anesthetic procedure was applied and the appropriate surgical intervention was performed.

Eligibility criteria:
inclusion criteria: * assured diagnosis of covid-19 by rt-pcr exclusion criteria: * no

Keywords: covid-19 anesthesia surgery outcomes
arcom® and arcomxl® polyethylene data collection

Conditions: Osteoarthritis of Hip

Summary: the purpose of this prospective clinical data-collection is to document the performance, clinical outcomes, and wear rates of arcom® and arcomxl® polyethylene. the data gathered will be collated and used as a part of biomet's post-market surveillance system and to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies. inclusion/exclusion criteria are identical to those indications and contraindications stated in the fda approved labeling for the device in 510(k) k926107 and 510(k) k043051. surgical techniques and patient care are to be standard for the surgeons participating in the protocol.

the study follow-up intervals are 6 weeks, 1 year, 2 years, 3 years, 5 years, and 10 years. demographic data is collected pre-operatively along with the harris hip score and ucla activity score. operative information includes the surgical technique and other standard operative information. follow-up information includes the harris hip score, ucla activity score, and radiographic data. anterior/posterior and frog leg lateral x-ray data is recorded to show radiolucencies, component position and angles. sites are also required to send in an anterior/posterior pelvis x-ray for wear analysis. implant durability is documented by asking the surgeon to record revisions, complications, and device related adverse events. all information collected is de-identified in compliance with hipaa regulations.

Eligibility criteria:
inclusion criteria: * noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis * rheumatoid arthritis * correction of functional deformity * treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques * revision of previously failed total hip arthroplasty exclusion criteria: * infection * sepsis * osteomyelitis