Kornimate/medical-research-clean huggingface dataset:
kenota 1 cws method comparison validation study

Conditions: Allergy; Immunoglobulin E-Mediated Allergic Disorder

Summary: the goal of this method comparison study is to compare total ige results obtained from at least 360 subjects aged less than 80 years old using four different testing arms comprising three types of samples and two testing methods. the main questions it aims to answer are: * are the kenota 1 devices easy to use by untrained operators at a clinic environment? * do tige results provided by the kenota 1 devices match the results provided by the fda-cleared phadia immunocap system? subjects will be asked to donate two fingerstick whole blood samples and one venous blood draw.

the method comparison study will compare total ige results obtained from at least 360 subjects aged less than 80 years old using four different testing arms. comprising three types of samples and two testing methods. arm (a): fresh fingerstick whole blood will be collected and tested on kenota 1 devices at three clia-waived sites (cwss). arm (b): venous plasma will be collected at the cwss and tested on kenota 1 devices at the central lab site. arm (c): venous plasma will be collected at the cwss and tested on phadia instruments (immunocap) at the central lab site. arm (d): venous whole blood will be collected at the cwss and tested on kenota 1 devices at the central lab site. the first method for this study is the kenota 1 system, which will be used across three (3) u.s. cwss. at each cws, 120 subjects will be recruited and will be asked to donate fingerstick blood and venous blood. three (3) untrained operators at each site will be running the freshly collected fingerstick blood samples on the kenota 1 devices provided at the site (testing arm a). site operators will also process and store the collected venous blood and venous plasma samples as instructed, and ship them to the central lab for further testing. the second method for this study involves testing at a central us laboratory as a clia-regulated laboratory. at the central lab, at least one trained lab operator will run frozen venous plasma (testing arm b) and frozen venous whole blood (testing arm d) collected from all subjects using the kenota 1 devices provided at the central lab. as the comparator method, one lab operator will run a second set of frozen plasma samples collected from all subjects on the phadia immunocap system (testing arm c). the method comparison validation study is expected to be completed within two months and will be run in conjunction with the multi-site reproducibility validation study. all testing will include a daily external control session on each device used, ensuring the devices are performing as expected.

Eligibility criteria:
inclusion criteria: * ages \<80 years * from all ethnic/racial backgrounds exclusion criteria: - individuals with skin damage, burns or scars at the site of venipuncture on both arms

Keywords: point of care total immunoglobulin e (tige) level in blood fingerstick kenota 1 system kenota 1 device allergy clinics allergist
establishment and characterization of patient-derived non-small cell lung cancer xenografts and cell cultures

Conditions: Non Small Cell Lung Cancer

Summary: xenografts and cell cultures provide sufficient material for analyses at the protein, rna and dna level. patient derived nsclc xenografts and cell lines are available but none however are asian in origin. given the emerging evidence to suggest inter-ethnic differences in nsclc biology, new models of preclinical drug evaluation should be designed and validated using asian tumors. furthermore, such models will allow studies of biological mechanisms of sensitivity and/or resistance and also the study of dynamic regulations under standardized conditions in the asian context.


Eligibility criteria:
inclusion criteria: * patients aged 21 years and above. * undergoing a surgical resection of tumor as part of clinical management exclusion criteria: * patient or legally acceptable representative unable to provide consent patient in the judgement of the study investigator, is medically unsuitable for this study
pilot prospective study of two methods of revascularization of the femoral artery (sfa): stenting in the sfa, and stenting of the sfa, supplemented by fasciotomy in hunter channel.

Conditions: Atherosclerosis of the Peripheral Artery

Summary: comparison of two methods for revascularization of the superficial femoral artery: stenting of the superficial femoral artery vs. stenting of the superficial femoral artery supplemented with fasciotomy in hunter canal in patients with steno-occlusive lesion of the femoro-popliteal segment of tasc c, d.

physiological flexions and extensions in hip and knee joints cause dramatic deformity in stented femoral and superficial femoral arteries, both axially and angularly. as a result, stents get broken, restenosed or thrombosed. some researchers report a 20 to 46% two-year incidence of broke stents in the superficial femoral artery, while restenosis and occlusion incidence vary from 21.8% to 53.3% . in addition to axial and angular stress, contributing to this untoward effect is musculofascial sheath which houses the artery in distal thigh. investigators suggest that standard stenting of an artery be augmented by incision of the anterior musculofascial sheath (septum intermuscular vastoadductoria) that will increase the mobility of distal part of the femoral artery, which will decrease frequency breakage of stents. review of the world literature yielded no peer instances of such improvement of stenting outcomes in the said arteries.

Eligibility criteria:
inclusion criteria: * patients with occlusive lesions of c and d type iliac segment, and with chronic lower limb ischemia (ii-iv degree by fontaine, 4-6 degree by rutherford). * patients who consented to participate in this study. exclusion criteria: * chronic heart failure of iii-iv functional class by nyha classification. * decompensated chronic "pulmonary" heart * severe hepatic or renal failure (bilirubin\> 35 mmol / l, glomerular filtration rate \<60 ml / min); * polyvalent drug allergy * cancer in the terminal stage with a life expectancy less than 6 months; * acute ischemic * expressed aortic calcification tolerant to angioplasty * patients with significant common femoral artery lesion * patient refusal to participate or continue to participate in the study

Keywords: angioplasty with stenting of the superficial femoral artery fasciotomy in hunter's channel breakage of stent
constraint induced movement therapy on infantile hemiplegia

Conditions: Hemiplegia

Summary: the purpose of this study is to assess the functionality of the affected upper limb in infantile hemiplegia by applying a protocol of modified constraint-induced movement therapy.


Eligibility criteria:
inclusion criteria: * children's hemiplegia medical diagnosis. * aged between 4 and 8 years. * lack of activity of the affected upper extremity. * overcoming 10th extension at the metacarpophalangeal and interphalangeal joint. * complete the 20 º of wrist extension of the affected upper extremity. * adequate cognitive development to understand verbal commands given for the execution of tasks. * cooperation in the execution of tasks. exclusion criteria: * to have vision problems that prevent them from carrying out the intervention. * having significant balance changes that endanger the child fall to bring a restriction in the affected upper limb. * submit uncontrolled seizures. * to have received botulinum toxin prior to 6 months prior to the intervention.

Keywords: upper extremity physical therapy modalities
the hope soap study: a hand-washing intervention among children in south africa

Conditions: Hand-washing Behavior; Diarrhea

Summary: the hope soap study is a randomised-control pilot study of a hand-washing intervention in which children in treatment households received a bi-monthly delivery of hope soap©, a colourful, translucent bar of soap with a toy embedded in its centre.


Eligibility criteria:
inclusion criteria: * enrolled in the family-in-focus program * caregiver provided informed consent * the age-eligible children were not involved in any other sort of ecd program (e.g. crèche or other day-care) exclusion criteria: * enrollment in an ecd program
intravenous iron: measuring response in anemic surgical patients

Conditions: Colorectal Neoplasm; Anemia

Summary: 20 patients will be recruited with confirmed colorectal adenocarcinoma and anemia who are planned to undergo surgery. all patients will be treated with a single dose of 1g intravenous ferric carboxymaltose (ferinject). it is hypothesized that intravenous iron supplementation is efficacious at raising haemoglobin levels and reduced blood transfusion requirements.

patients who are anemic at the time of operation have been shown to have an increased frequency of complications including wound infection and longer post-operative admissions. similarly, patients who are anemic at the time of their cancer operation are more likely to require a blood transfusion which may increase the risk of recurrence of the cancer. at present, oral iron is often used to treat anemia preoperatively in an attempt to minimize the risk above. this drug is often poorly tolerated due to the side effect profile. blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. in order to overcome these issues, intravenous iron preparations have been developed and have improved in safety. this is open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. the outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles operative complications and hospital length of stay. the role of hepcidin as a biomarker of treatment response will also be assessed. all data will be confidentially recorded on a case report form, as will drug reactions and side effects.

Eligibility criteria:
inclusion criteria: * age \> 18 years * diagnosed with colonic or rectal adenocarcinoma * defined date of operation at least 14 days from recruitment to study * confirmed anemia * females of child bearing age must agree to use a medically accepted form of contraceptive exclusion criteria: * patient's who are unable to consent * recognized allergy or intolerance of the study drug or excipients * patients with previous or current hematological disease that in the investigators' opinion would confound the diagnosis of anemia

Keywords: adenocarcinoma anemia blood transfusion colorectal surgery preoperative care perioperative care postoperative care iron hematinics hepcidin quality of life postoperative complications
pain assessment during general anesthesia

Conditions: Pain

Summary: during general anesthesia, two treatments are used : hypnotic and opioid treatment. opioid treatment is used for pain assessment. the change in haemodynamic variables and clinical sign are evaluated during anesthesia for pain assessment but these changes are not specific every time. the main of this study is to investigate the relationship between calculated compartment concentration of remifentanil (opioid) and the parameters from hrv (heart rate variability) and apv (arterial pressure variability) before a standard noxious stimulation during general anesthesia at calibrated hypnosis level. our hypothesis is that nociceptive stimulation would have reproductible effects on hrv, and that these effects would be blunted or abolished by by adequate analgesia. the current study is thus designed to analyse hrv and apv in patients with stable hypnosis, before and during nociceptive surgical stimulation, at different levels of analgesia.


Eligibility criteria:
inclusion criteria: * adult patients under 55 years-old * asa status 1 or 2 * scheduled to undergo general anesthesia for different types of surgery (neurosurgical or medullar surgery, ear, nose or throat surgery or orthopedic surgery) exclusion criteria: * history of cardiac or autonomic disease * diabetes * obesity (bmi\>30 kg/m2) * medication altering autonomic nervous system tone * history of eyes surgery

Keywords: pain assessment anesthesia analgesia opioid hrv apv autonomic nervous system (ans) pupil size
the effect of exercise training programs on balance in older adults with cvd

Conditions: Aging; Cardiovascular Diseases

Summary: individuals of advanced age with cardiovascular disease are at higher risk of fall.the aim of this study is to explore the effect of specific exercise program based on balance and coordination on stability parameters


Eligibility criteria:
inclusion criteria: * has cardiovascular disease, under the supervision of a cardiologist * participates in a cardiovascular rehabilitation center * able to undergo physical activity for 60 minutes twice a week exclusion criteria: * all other
respiratory strength training in heart transplant recipients

Conditions: Dysphagia; Heart Transplant Recipients

Summary: this research study is investigating whether completing breathing exercises before surgery helps heart transplant patients recover after surgery. previous studies have shown that breathing exercises can improve breathing, cough, and swallow function in patients with other diseases/conditions. the current study will investigate the impact of a preoperative respiratory muscle strength training program on breathing and cough function, swallow function, patient-reported eating and swallowing fatigue, and health outcomes in individuals undergoing heart transplantation. participants will: * undergo tests of breathing, cough, and swallow function * complete questionnaires about the treatment, their swallow function * complete breathing exercises daily

this study will involve three in-person research evaluations to our lab or in the hospital that will last 45 minutes- 1 hour and will consist of a screening, breathing and cough testing, swallow function testing, and completion of questionnaires. following the initial research evaluation, individuals will complete daily exercises of active or sham respiratory muscle strength training for several weeks with one telehealth or in-person session per week. the exercises will take 10-15 minutes to complete, and individuals will fill out training logs daily. prior to transplantation and after completion of the breathing exercises, individuals will undergo a second research evaluation. then, following surgery, individuals will undergo a third research evaluation and outcomes will be tracked via the electronic health records system.

Eligibility criteria:
inclusion criteria: 1. adult (18-90 years old) 2. not pregnant 3. undergoing evaluation or actively waitlisted for heart transplantation at vumc with a waitlist status of 1-6 4. have a computer, tablet or electronic device with a stable internet connection for telehealth sessions (outpatient) 5. be willing to undergo testing procedures and complete the exercise training program. exclusion criteria: 1. individual \ 90 years old 2. pregnant 3. no access to a computer, tablet or electronic device with a stable internet connection for telehealth sessions 4. unwilling or unable to undergo testing procedures and complete the exercise training program.

Keywords: dysphagia deglutition deglutition disorders swallowing breathing cough swallowing disorders heart transplant recipients respiratory muscle strength training
a retrospective evaluation of the intraocular pressure spikes with loteprednol and loteprednol/tobramycin

Conditions: Ocular Hypertension

Summary: patient charts will be reviewed to evaluate the incidence of intraocular pressure spikes while on loteprednol etabonate ophthalmic suspension 0.5%, loteprednol etabonate (0.5%) and tobramycin (0.3%)


Eligibility criteria:
inclusion criteria: * any patient who experienced an iop spike while using lotemax or zylet will be included exclusion criteria: * n/a
low resistance venous blood flow restriction training (lr-vbfrt) on biceps brachii muscle performance

Conditions: Muscle Weakness Condition

Summary: resistance training has been widely recognized as an effective stimulus for increasing skeletal muscle size and strength. this study intends to compare the effects of high resistance training without blood flow restriction and the low resistance training with blood flow restriction training on bicep muscle performance.

the study is randomized control trail, which is being conducted in riphah college of rehabilitation sciences. sample size of 40 individual was calculated using epitool with 95% confidence interval (ci) and power 80%. individual will be screened out according to inclusion criteria. individuals will be allocated randomly into two groups, 20 in high resistance training group and 20 in low resistance training with blood flow restriction group by sealed envelope method. high resistance training will be use in control group.low resistance with blood flow restriction training will be used in experimental group. assessment will be done on baseline 2-4 days prior to the intervention and after 8 weeks of training. data will be analyzed on spss version 21.

Eligibility criteria:
inclusion criteria: * males * age: 20-28 year * body mass index: 18.5-24.9 exclusion criteria: * vascular disease * upper limb pathology requiring surgical intervention * upper limb musculoskeletal issues * blood pressure \>140/90 * coronary artery disease * venous thromboembolism * congenital cardiac diseases * syncope, arrhythmias, smokers * alcohol use * supplements intake * whey protein intake

Keywords: exercise training
diclofenac potassium alone versus diclofenac potassium with hyoscine-n-butyl bromide (hbb in endoscopy

Conditions: Pain

Summary: diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (nsaid) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions.

diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (nsaid) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions. . as with all nsaids, diclofenac exerts its action via inhibition of prostaglandin synthesis by inhibiting cyclooxygenase-1 (cox-1)

Eligibility criteria:
inclusion criteria: * 1. patients indicated for diagnostic hysteroscopy including infertility, bleeding, suspected intrauterine pathologies (eg polypi , septea) 2. reproductive age 20 - 40yrs exclusion criteria: * 1. menopausal and amenorrhic patients 2. contraindication to office hysteroscopy such as:- pelvic inflammatory disease, marked cervical stenosis, pregnancy
pk/pd study of posaconazole for empiric treatment of invasive fungal infections in neutropenic patients or treatment of refractory invasive fungal infections (study p01893)

Conditions: Mycoses

Summary: this phase ii study will be conducted to: 1. evaluate the pharmacokinetics, safety, tolerance, and efficacy of different dosing schedules of posaconazole in immunocompromised hosts with a variety of refractory invasive fungal infections or in subjects who require empiric antifungal therapy and 2. identify the dosing schedule that provides the most consistent therapeutic drug exposure in this patient population.

this is an open-label, randomized, parallel group, study of pharmacokinetics, safety, tolerance, and efficacy of posaconazole in the treatment of immunocompromised hosts with refractory invasive fungal infections or in subjects who require empiric antifungal therapy. the projected number of subjects planned for enrollment is 100 evaluable subjects. the number of planned study sites is approximately ten in the united states and approximately eight in the rest of the world.

Eligibility criteria:
inclusion criteria: * a proven, either probable or possible invasive fungal infection which is refractory to standard antifungal therapies. * subjects who received \>72 hours of systemic empiric antibacterial therapy and are neutropenic (\ 38c (or \>100.4f)twice in the last 48 hours, or have a recurrence of fever (oral temperature, \>38c or \>100.4f) while receiving broad spectrum antibacterial therapy after prior resolution of fever while on antibacterial therapy. * able to take oral medication or take medication via enteral feeding tube.

Keywords: aspergillosis, candidiasis, mucormycosis, cryptococcosis invasive fungal infections
a study to collect bone marrow for process development and production of bm-msc to treat severe covid19 pneumonitis

Conditions: Healthy Volunteers for Bone Marrow Donation

Summary: the covid-19 pandemic, commonly referred to as "coronavirus", first began in the city of wuhan, china in december 2019. this virus has since spread globally, with infections reported in nearly every country. covid-19 targets the body's respiratory system, where infections can be found in the nose, throat and lungs. the effect of covid-19 infection is very variable, where many people might not know that they have been infected and have recovered from covid-19. however, covid-19 infection can cause people to have difficulty breathing. this can be severe enough to require hospitalisation and potentially intensive care treatment. while they are being treated in hospital, covid-19 infected patients can be found to have inflamed tissue in their lungs (referred to medically as "pneumonitis"). this inflammation is thought to be caused by their body's immune systems overacting to the infection rather than the covid-19 virus itself. by potentially dampening down this overreaction of their immune system, it is hoped that covid-19 patients with inflamed lungs have better and quicker chance to survive. mesenchymal stromal cells (mscs) have been shown to have anti-inflammatory and healing properties on injured tissue. mscs have been trialled in various diseases but have not yet been tested on patients with covid-19. in this study, the investigators will obtain bone marrow from healthy volunteers to develop a cell-based treatment for covid-19-related pneumonitis. the investigators will also determine whether it is feasible to recruit bone marrow donors in a clinically useful timeframe to treat covid-19 patients. a future trial, comet20, will use the bone marrow-derived mscs (bm-mscs) manufactured in comet20d to treat covid-19 patients suffering with pneumonitis, to determine whether the bmmscs can reduce the likelihood for mechanical ventilation and reduce hospitalisation.


Eligibility criteria:
inclusion criteria: * have given written informed consent to participate * be aged between 18 and 40 years old * have eastern cooperative oncology group (ecog) performance status 0 * be negative for mandatory infectious disease markers (idm) as per world marrow donor association (wmda) guidelines * present a negative sars-cov2 screen * show absence of clinical symptoms of covid-19 (not have been in known covid-19 contact within the previous 14 days, adherence to national social distancing guidelines for 14 days) * have a bmi \<35kg/m\^2 * women of childbearing potential need a negative pregnancy test (urine or blood) within 7 days prior to the marrow collection exclusion criteria: * any major disease which would represent a contraindication to bone marrow donation based on wmda guidelines * presence of any previous or active malignancy (other than non-melanoma skin cancer) * any other concurrent severe and/or uncontrolled medical condition * women who are pregnant or breast-feeding * any acute or chronic back complaint * presence of anaesthetic risk factors