Kornimate/medical-research-clean huggingface dataset:
upper extremity rehabilitation using game rehabilitation system with functional electrical stimulation for stroke patients

Conditions: Stroke

Summary: the purpose of the present study was to investigate the effects of game-based virtual reality rehabilitation combined with functional electrical stimulation on distal upper extremity function, and compare the findings to those of functional electrical stimulation in stroke survivors.


Eligibility criteria:
inclusion criteria: * first-ever ischemic or hemorrhagic stroke * wrist extensor of medical research council scale 1\~3 * no clinical evidence of limited passive range of motion of affected wrist exclusion criteria: * age \<18 years * severe aphasia resulting in communication difficulties confounding intervention and outcome measures * severe cognitive impairment resulting cooperation difficulties * spasticity \> modified ashworth scale 1+

Keywords: stroke rehabilitation hand game functional electrical stimulation virtual reality
application of non-invasive neurophysiological methods in predicting and evaluating postoperative pain in adult patients undergoing major thoracic surgery

Conditions: Postoperative Pain, Acute; Postoperative Pain, Chronic; Postoperative Pain After Thoracic Surgery

Summary: the primary aim of this study is to explore the relationship between alpha electroencephalographic oscillations, particularly peak alpha frequency (paf), pupillometry, intraoperative nociception level (nol) and postoperative pain following major thoracic surgeries. goals to investigate the use of preoperative eeg as a biomarker for the prediction of postoperative pain to investigate the use of pupillometry in postoperative pain prediction and evaluation to test intraoperative nol as a predicting factor of postoperative pain


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older scheduled for open lung lobectomy due to early-stage lung cancer. exclusion criteria: * 1) severe neurological disorders (e.g. dementia) that could interfere with eeg recordings or pain testing. 2) severe psychiatric conditions such as major depression, schizophrenia, or active drug abuse. 3) preoperative analgesic therapy, which may alter eeg signals (boord et al. 2008). 4) diabetes mellitus 5) chronic pain of any etiology 6) acute pain from any cause

Keywords: postoperative pain pupillometry eeg peak alpha frequency (paf) nociception level index (nol)
lower urinary tract symptoms screening questionnaire

Conditions: Cystocele

Summary: the purpose of this study is to determine the validity of a screening tool which has been designed to detect the presence or absence of lower urinary tract symptoms in the general female population.


Eligibility criteria:
inclusion criteria: * healthy participants, 18 years of age and older with any gynecological symptoms exclusion criteria: * patients with lower urinary tract symptoms and pelvic floor dysfunction

Keywords: urinary tract
measuring placebo effect by elimination and investigating mechanism of action

Conditions: Placebo Effect; Placebo Mechanisms of Action

Summary: we propose to measure the effect of placebo by elimination as well as by a "balanced placebo" design, determine its interaction with active drug, and explore whether placebo exerts part of its effect at the pharmacokinetics level.

placebos have been in use for centuries in medical practice. however, there is continued controversy regarding their effectiveness and mechanisms of action. the results of the study are expected to further our understanding of a widely used medical intervention, i.e., placebo, and of how to maximize its potential beneficial effect. it will also help assess the appropriateness of measuring the placebo effect by elimination, which has important ethical implications in relation to the design of randomized clinical trials. comparison: caffeine vs placebo. dependent variables:4 hours area under the curve (auc) of pharmacodynamics endpoints as well as pharmacokinetics endpoints in a subgroup.

Eligibility criteria:
inclusion criteria: * males and nonpregnant females 18 and 40 years of age with at least high school education. exclusion criteria: * include evidence of clinically relevant deviation from normal health (such that it may affect the endpoints, make the ingestion of caffeine dangerous, or affect the pharmacokinetics/pharmacodynamics of caffeine), * pregnancy, * poor venous access, * hypertension (more than 140/90), * heart disease, * history of panic attacks, * average daily caffeine consumption of more than 300 or less than 100 mg, * smoking, * alcohol abuse, * taking any medication other than birth control bills (including over-the-counter drugs) within one week from starting the study, * hypersensitivity to caffeine or related compounds, * hemoglobin of less than 13 gm/l, and recent (one week) acute illness

Keywords: placebo effect caffeine systolic bp vas
evaluation of kaletra therapy over the long-term

Conditions: Human Immunodeficiency Virus

Summary: long term observation of patients under lopinavir/ritonavir containing therapy

three to five year observation of lopinavir/ritonavir therapy. reporting groups are 1) therapy-naïve patients (144 weeks), 2) therapy-experienced but protease inhibitor naïve patients (240 weeks,) and 3) non-b subtype infected patients (240 weeks). these three groups of participants with hiv-1 infection were at first registered as three different studies: kal1ro (this study, nct01083810, n=137), kal2ro /kal5ro (nct01083836, n=92), and kal6ro (nct01081470, n=55) but were now reconciled under kal1ro (nct01083810) as a single study with three reporting groups.

Eligibility criteria:
inclusion criteria: * patients infected by hiv-1 * age greater than or equal to 18 years exclusion criteria: * as described in smpc (summary of product characteristics) at the time of prescription

Keywords: human immunodeficiency virus infection kaletra resistance mutations alternative therapy regimen
pharmacokinetic/pharmacodynamic study of doripenem in febrile neutropenic patients

Conditions: Febrile Neutropenia

Summary: primary: to determine the serum pharmacokinetics (pk) of doripenem in febrile neutropenic patients. secondary: monte carlo simulations tested against various gram-negative isolates and reported as probability of target attainment (40% time (ft)\> minimum inhibitory concentration (mic))

background: doripenem is a group 2 carbapenem with enhanced in vitro activity against gram-negative bacteria including pseudomonas aeruginosa. currently, there is a paucity of pharmacokinetic/pharmacodynamic data on doripenem in patients with febrile neutropenia. objectives: to conduct a pharmacokinetic and safety evaluation of two doses of doripenem in febrile neutropenic patients and provide probability estimates of attaining effective drug exposure against common gram-negative pathogens. methods: we obtained multiple blood samples from 12 adult patients with febrile neutropenia who were receiving either 500 mg or 1000 mg of doripenem iv over 4-hours every 8 hours. following at least 2 doses, serum concentrations were measured in each subject at 1, 4, 6 and 8 hours after initiation of a dose by a validated hplc assay. the derived pharmacokinetic (pk) parameters from these serum levels were utilized to perform a 5000 patient monte carlo simulation against bacteria with minimal inhibitory concentrations (mics) of 0.008 to 64 mg/l to determine probability estimates of time of free drug concentration \> mic (ft\>mic). results: the mean pk parameters in these patients were a volume of distribution (vd) of 43.9l, an elimination rate constant (k) of 0.37 hr -1, a total clearance (cl) of 14.4 l/h, and an area under the concentration-time curve (auc) of 57.6 mg∙h/l. an optimal probability of target attainment (40% ft\>mic) of 90% was obtained against bacteria with mics ≤ 2.0 and ≤ 4.0 mg/l with 500 mg and 1000 mg doses, respectively. adverse events associated with doripenem were not observed in these patients. conclusions: the findings from this analysis of doripenem suggest that higher doses as well as prolonged infusions may be necessary to optimally treat selected gram-negative bacteria (eg. pseudomonas aeruginosa) in patients with febrile neutropenia

Eligibility criteria:
inclusion criteria: * adult neutropenic (\< 500 cells) patients who are febrile exclusion criteria: * patients with creatinine clearance \< 30 ml/min or allergy to carbapenems will be excluded.

Keywords: neutropenia doripenem
oral penicillin challenge and allergy de-labeling in children

Conditions: Penicillin Allergy

Summary: the primary purpose of this study is to investigate the portion of penicillin allergy labels that are not true allergies using oral amoxicillin challenges among pediatric patients. the secondary purpose is to evaluate the safety and feasibility of administering oral penicillin allergy challenges in the pediatric emergency department.


Eligibility criteria:
inclusion criteria: 1. patients in the pediatric emergency department who are 2-17 yo and labeled as penicillin-allergic (including amoxicillin or other penicillin allergies) 2. patients at low risk of anaphylaxis as determined by the study questionnaire 3. patients who would normally be prescribed amoxicillin, amoxicillin-clavulanate or another penicillin for their current bacterial infection, including otitis media, group a streptococcal pharyngitis, pneumonia. sinusitis, dog and cat bite wounds, regimens for helicobacter pylori eradication, or other acute infections deemed susceptible. 4. patients who are interested in participating 5. patients who have an acceptable surrogate to give consent on the subject's behalf 6. patients whose surrogate (parent/caregiver) speaks english or spanish exclusion criteria: 1. patients who are uninterested in participating, or their parents/caregivers are not interested in having them participate 2. patients who have multiple drug allergies

Keywords: penicillin anaphylaxis allergy oral challenge amoxicillin pediatric emergency department
rdea3170 pk/pd study

Conditions: Gout

Summary: the purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of rdea3170 when given as single or multiple doses


Eligibility criteria:
inclusion criteria: * subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2. * subject has a screening serum urate level 4 to 7 mg/dl * subject is free of any clinically significant disease or medical condition, per the investigator's judgment. exclusion criteria: * subject has a history or suspicion of kidney stones. * subject has undergone major surgery within 3 months prior to screening. * subject donated blood or experienced significant blood loss within 12 weeks prior to day 1 or gave a plasma donation within 4 weeks prior to day 1. * subject has clinically unacceptable physical examination, per the investigator's judgment. * subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the investigator's judgment. * subject has screening clinical safety laboratory parameters (serum chemistry \[other than serum creatinine and serum urate\], hematology, coagulation or urinalysis) that are outside the normal limits and are considered clinically significant by the investigator. * subject has a serum creatinine value above the upper limit of normal at the screening visit. * subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the investigator's judgment. * subject has a history of cardiac abnormalities * subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to day 1.
efficacy of helium/oxygen compared to air/oxygen in severe exacerbation of chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the primary objective of the study is to evaluate the efficacy of helium/oxygen (he/o2) 78%/22% compared to a conventional air/o2 mixture in reducing endotracheal intubation rate and mortality in patients with severe hypercapnic exacerbations of chronic obstructive pulmonary disease (copd) during their index intensive/intermediate care unit (icu) stay.

patients eligible for this study are critically ill patients with copd admitted in intensive care unit for an exacerbation of their chronic disease with hypercapnic acute respiratory failure. the patients will receive an helium/oxygen mixture or an air/oxygen mixture for a maximum of 72 hours during non-invasive ventilation (niv) and niv-free sessions. during niv sessions, gas mixtures will be administered using a ventilator suitable for niv with either he/o2 or air/o2 and a niv facemask. patients will be followed until hospital discharge and then contacted by phone up to the 6th month after randomization.

Eligibility criteria:
inclusion criteria: * patient with known or suspected copd * patient presenting current exacerbation of copd with hypercapnic acute respiratory failure * patient eligible for non-invasive ventilation (niv) * patient admitted in an icu exclusion criteria: * patient who had lung transplant * patient having a contraindication to niv * patient with tracheostomy * patient requiring oxygen flow rate \> 6 l/min or inspired oxygen fraction (fio2) \> 0.50 * patient admitted in the icu for more than 24 hours and/or having received niv in icu for more than 6 hours (in total) for the current exacerbation of copd

Keywords: exacerbation of copd helium/oxygen icu non-invasive ventilation patient with known or suspected copd patient admitted in an icu patient presenting current exacerbation of copd
a study to learn about the treatment ltp001 in healthy participants (part a) and in participants with pah (part b)

Conditions: Healthy Volunteers, Pulmonary Arterial Hypertension

Summary: a study to learn about the treatment ltp001 in healthy participants (part a) and in participants with pah (part b)

the cltp001a12202 study will explore the safety, tolerability, and pharmacokinetics of ltp001 in healthy volunteers (part a) and will evaluate the safety and efficacy (part b) followed by safety extension in participants with pulmonary arterial hypertension.

Eligibility criteria:
part a inclusion criteria: * healthy males and non-child-bearing potential females part a exclusion criteria: * clinically significant ecg or cardiac abnormalities, any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant in the study other protocol-defined inclusion/exclusion criteria may apply. part b inclusion criteria: -confirmed diagnosis of pah, pre-randomization pvr ≥400 dyn.sec.cm-5, treatment with stable doses of standard-of-care pah therapies, 6-minute walk distance ≥ 150 m and ≤450 m. part b exclusion criteria: any surgical or medical condition which may place the participant at higher risk from his/her participation in the study women of child-bearing potential unless they are using highly effective methods of contraception sexually active males unwilling to use a condom during intercourse while taking study treatment and for 24 hours after stopping study treatment. history of hypersensitivity to any of the study treatments or excipients other protocol-defined inclusion / exclusion criteria may apply

Keywords: ltp001 pulmonary arterial hypertension pah pvr
dermoscopic monitoring of pediatric melanocytic nevi regarding pattern and diameter changes

Conditions: Nevus, Pigmented

Summary: childhood and adolescence are a dynamic process in terms of nevogenesis, and the development and growth of new melanocytic nevus is frequently observed. melanomas, although rare, can also be seen in the pediatric age group. therefore, nevus monitoring with videodermoscopy may be necessary in the pediatric age group. aim of our study is to show the dynamic pattern and diameter modifications in pediatric nevi.

aim of our study is to show the dynamic pattern and diameter modifications in pediatric nevi. patients who applied to the dermatology clinic of istanbul training and research hospital between january 2008 and january 2022, were diagnosed with pediatric melanocytic nevus clinically and dermoscopically were included. patients who had records for at least twice with videodermoscopy every 3 months were included. in the study, 301 pediatric melanocytic nevi belonging to 50 patients were evaluated. the following characteristics were recorded in a database specifically designed for the study:demographic findings of the patients, nevus localization, nevus pattern (baseline and follow-up), nevus diameter (base line and follow-up at 3/12/36th months), histopathological results of nevi that underwent total excision were recorded. the change in nevus diameter during follow-up was measured in millimeters based on the longest axis. presence of peripheral globules, outcome of peripheral globules, characteristics of peripheral globules were recorded. characteristics of peripheral globules were evaluated according to being around the entire lesion (circumferential) versus focally presence, typical (uniform shape and colors) and being regular (single rim of globules or multiple rim of globules)

Eligibility criteria:
inclusion criteria: * subjects \<18 years of age * subjects who have dermoscopic diagnosis of melanocytic nevus * subjects who had dermoscopic follow up for at least 3 months exclusion criteria: * subjects \>18 years of age
effects of long term ventilation support on the quality of life of als patients and their families

Conditions: Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Nervous System Diseases; Spinal Cord Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies

Summary: amyotrophic lateral sclerosis (als) is a serious rapidly progressive disease of the nervous system. the average survival from the time of diagnosis is two to three years. the patient physical and psychological sufferings in als are immense, and apart from riluzole, there is no effective treatment. care of advanced als have an estimated cost of 4-8 million nok per year. perhaps the most challenging topic of als care is the decision to extend ventilation support into the stages of disease that require treatment both during day and night. in these cases, treatment is clearly life-sustaining and although quality of life may be maintained, the burden of caregiving imposed upon family or health care workers is huge, regardless of tracheostomy (tiv) or non-invasive (niv) modality. the present study is a longitudinal questionnaire study in norway measuring overall quality of life, health-related quality of life, and disease-specific quality of life in als patients, partners and children before and after the introduction of life sustaining ventilation support. the investigators aim to increase the knowledge on how life-sustaining ventilation support with niv or tiv affects the quality of life in als patients, life partners and children. the results from the study may provide crucial information for clinicians and patients on one of the most difficult ethical issues of als treatment. the investigators anticipate that this information will facilitate a shared decision making processes, weighing benefits and disadvantages in a wider perspective.


Eligibility criteria:
inclusion criteria for patients: 1. a clinical diagnosis of probable als according to the revised el escorial criteria 2. progression of the illness leading the consulting physician to offer treatment with ltmv 3. can communicate in norwegian inclusion criteria for partners of als patients: 1. partner of a patient with als with progression of the illness leading the consulting physician to offer treatment with ltmv 2. can communicate in norwegian inclusion criteria for children: 1. children from 8 years and older having a parent who suffers from als with progression of the illness leading the consulting physician to offer treatment with ltmv 2. can communicate in norwegian exclusion criteria for patients, partners and children of als patients: 1. potential participants with cognitive impairment or dementia.

Keywords: quality of life overall quality of life health related quality of life disease specific quality of life ventilation support non-invasive ventilation support invasive ventilation support
study of alxn1840 on the metabolism of a cyp2b6 substrate in healthy participants

Conditions: Wilson Disease

Summary: this is a phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine the effect of alxn1840 on the metabolism of bupropion, a sensitive cytochrome p450 2b6 (cyp2b6) substrate, in healthy male and female participants. the safety and tolerability of alxn1840 will be determined along with alxn1840 pharmacokinetics (pk) in plasma as measured via total molybdenum with the coadministration of bupropion.

the study is being conducted as a randomized, 2-period, 2-sequence, cross-over study to determine the effect of a single dose of alxn1840 (perpetrator) on the single-dose bupropion (victim) kinetics in healthy male and female participants. the study has a screening period (day -28 to day -2), two 11-day study periods (day 1 to day 11) with a minimum of 14 days between doses of bupropion, and an end of study visit (day 15 ± 2 days) after period 2 dosing. participants will report to the clinical research unit on the day prior (day -1) to both dosing periods. all participants will receive 1 treatment in each study period; treatment order will be defined based on randomization: treatments a and b. the time between dosing bupropion alone or in combination with alxn1840 in each treatment sequence will be a minimum of 14 days. the pk profile of alxn1840 and bupropion will be determined by blood sampling following single dose administration.

Eligibility criteria:
inclusion criteria: * adequate venous access in the left or right arm to allow the collection of blood samples. * body weight ≥ 45 to ≤ 100 kilograms (kg) and body mass index within the range of 18 to \< 30 kg/meter squared. * willing and able to follow protocol-specified contraception requirements. * capable of giving signed informed consent. exclusion criteria: * history or presence of/significant medical history. * clinically significant multiple or severe allergies. * lymphoma, leukemia, or any malignancy within 5 years. * breast cancer within the past 10 years. * serum creatinine \> upper limit of normal (uln) of the reference range. * alanine aminotransferase, aspartate aminotransferase, or total bilirubin \> uln. * current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of gilbert's syndrome or asymptomatic gallstones). * qtc \> 450 milliseconds (msec) for male participants or \> 470 msec for female participants.

Keywords: cytochrome p450 healthy alxn1840
a study of mircera in renal anemia among filipino chronic kidney disease patients

Conditions: Anemia

Summary: this study will assess the efficacy and safety of once monthly administration of mircera in filipino patients with chronic kidney disease who are either on dialysis or predialysis, and not receiving erythropoiesis stimulating agents.patients will receive mircera at a starting dose of 0.6 micrograms/kg sc every 2 weeks, with dose adjustments until a target hemoglobin level is achieved, and then dosing will continue every 4 weeks. the anticipated time on study treatment is 3-12 months, and the target sample is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * chronic kidney disease; * anemia (hb \>8 and \<11 g/dl); * regular dialysis or predialysis, not treated with esa. exclusion criteria: * transfusion of red blood cells during previous 8 weeks; * poorly controlled hypertension; * overt gastrointestinal bleeding, or other bleeding necessitating transfusion during previous 8 weeks; * active malignant disease (except melanoma of skin).