Kornimate/medical-research-clean huggingface dataset:
softhand comparison study

Conditions: Upper Extremity Injury; Upper Extremity Deformities, Congenital; Amputation, Traumatic; Amputation, Congenital

Summary: a trial to compare the performance of the softhand pro (shp) and ossur i-limb in people with transradial limb loss over an 8-week period.

this study will measure improvements in outcomes obtained from laboratory testing of the shp and i-limb from baseline to after 8 weeks of daily use. a secondary analysis will incorporate the subjects' existing prosthetic hands. finally, surveys and usage data collected through the shp and i-limb firmware during daily use will complement data the aforementioned outcomes to explore factors that may be related to differences in grasping and manipulation performance.

Eligibility criteria:
inclusion criteria: 1. the individual can successfully use their prosthesis, list the components used and that their current prosthesis is fitting properly (by performing a tension analysis); 2. the individual had unilateral transradial limb loss more than 6 months before the clinical evaluation because, to use a myoelectric prosthesis, the residual limb volume needs to be stable; 3. the individual is a user of one or more common myoelectric prosthetic hands, such as the sensor hand speed and bebionic. exclusion criteria: 1. individuals who have had transradial amputation for less than 6 months; 2. individuals who have been fit and trained to use a prosthesis but chose not to use one; 3. individuals who use the i-limb quantum myoelectric prosthesis; 4. clinical history of brachial plexopathy, cervical radiculopathy or polyneuropathy; 5. orthopedic, joint degeneration (i.e., arthritis, self-reported) affecting the hand or cervical spine that severely limit upper limb function (observed); 6. visual problems that would interfere with the grasping; 7. co-existing central nervous system disease with symptoms that limit upper extremity function (e.g., multiple sclerosis, motor neuron disease, myasthenia gravis, parkinson's disease, dystonia) revealed in medical history; 8. limited range of motion as assessed through range of motion testing; 9. inability to follow study instructions; 10. use of medications that might affect sensory and/or motor functions.
establishing a standard for peri-operative implantable cardioverter defibrillator (icd) patient education

Conditions: Arrhythmia

Summary: an implantable cardioverter defibrillator (icd) administers a shock to terminate potentially life-threatening cardiac arrhythmias. the device saves lives, but presents psychological challenges for patients. at present, there is a paucity of brief interventions for icd patients designed for administration in a clinic setting that considers issues of cost, time, and available resources. the present study examined the impact of a brief cognitive behavioral (cbt) educational intervention on primary endpoints of patient acceptance and quality of life and secondary endpoints of depression and anxiety. it was hypothesized that the intervention would result in significant improvements primary and secondary endpoints for participants in the intervention group.


Eligibility criteria:
inclusion criteria: * 18+ years old * literate * newly implanted with an implantable cardioverter defibrillator (icd) exclusion criteria: * documented neurological sequelae associated with cva or dementia * documented cognitive impairment * reported illiteracy * previously implanted icd

Keywords: behavioral intervention implantable cardioverter defibrillator psychosocial education anxiety depression
acute haemodynamic effects of peritoneal dialysis as evaluated by sphygmocor technology

Conditions: Peritoneal Dialysis

Summary: subjects with peritoneal dialysis are randomized to different groups. the different groups receive different intra-abdominal volumes and different glucose-concentrations. the effects on blood pressure and other cardiovascular parameters (e.g. central blood pressure, augmentation index, ...) will be evaluated.


Eligibility criteria:
inclusion criteria: * subjects with peritoneal dialysis * aged 18-80 years
effects of a small protein and lipid preload on glucose tolerance in subjects with impaired glucose homeostasis

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is: * to measure the size of the effect on glucose tolerance of a small mixed protein and lipid meal given as a pre-load in individuals with different glucose tolerance status * to investigate the underlying mechanisms by accurately evaluating beta cell function, insulin sensitivity, insulin clearance and glucose kinetics (oral absorption, endogenous production, rate of utilization) together with gut hormones plasma concentration.

as supported by experimental and clinical data, oral carbohydrate tolerance is influenced by the coingestion of nutrients through multiple mechanisms. the ingestion itself, the contact with the gastric mucosa, the arrival into the intestine and the subsequent digestion are known to produce neural reflexes, hormonal responses and plasma substrates gradients which, by modulating gastric emptying, insulin secretion and insulin clearance participate in the regulation of postprandial glycaemia. the size of this effect is influenced by a number of factors: the specific nutrient chemical characteristics (fat vs protein and composition) and their physical properties (solid vs liquid), the timing (pre-load vs coingestion) and finally the individual glucose tolerance status. to our knowledge, the effect on glucose excursions of a combination of protein and fat given before carbohydrate is still unknown and also unknown is the contribution of different mechanisms involved in the control of glucose homeostasis in subjects with different degrees of glucose tolerance.

Eligibility criteria:
inclusion criteria: * healthy, prediabetic or diet-controlled type 2 diabetic patients * subjects ≥ 18 and ≤65 years of age * lean, overweight or obese (bmi: 18 to 35 kg/m2) * normal liver and kidney function * normal thyroid function * read and understood the informed consent form and signed it voluntarily exclusion criteria: * liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases. * type 1 or insulin treated diabetes. * pregnancy or lactation * illicit drug abuse or alcoholism * subject treated with insulin or treatment * subjects taking anoretic drugs * subjects on steroid treatment * subjects after bariatric surgery.
bacteriophage therapy in patients with prosthetic joint infections (pji)

Conditions: Prosthetic Joint Infection

Summary: this is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.

this is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections of the hip or knee caused by at least 1 of the following organisms: staphylococcus aureus, staphylococcus epidermidis, staphylococcus lugdunensis, streptococcus spp., enterococcus faecium, enterococcus faecalis, escherichia coli, pseudomonas aeruginosa, or klebsiella pneumoniae. this study will compare the safety and efficacy of dair procedure + phage therapy + antibiotics versus dair procedure + placebo + antibiotics.

Eligibility criteria:
inclusion criteria: * males or females ≥18 years of age * recurrent pji of the knee or hip * female patients of childbearing potential who agree to use contraception. * confirmed phage match * no anticipated need for long-term antibiotics exclusion criteria: * soft tissue defect requiring reconstruction * hardware misalignment * additional orthopedic hardware in connection with the infected prosthesis * active infection (other than pji) requiring long term iv antibiotics * unable to tolerate sat * septic shock or hemodynamic instability * stage 4 or greater chronic kidney disease * liver disease * decompensated heart failure * positive drug screen * receiving chemotherapy * immunocompromised * treatment with antiviral medication within 2 weeks prior to randomization * currently participating in another clinical trial * known phage allergy * pregnant/ breast feeding * lack of capacity to consent

Keywords: prosthetic joint knee hip phage bacteriophage prosthetic joint dair
a cross sectional evaluation of the development in children age 4 to 7 infected or exposed to hiv from the anrs 12140 cohort (pediacam)

Conditions: HIV; HIV-uninfected Children; Children Exposed to HIV

Summary: this study aims to perform a comprehensive neuro-cognitive evaluation of the 4-7 year old children from the pediacam cohort (anrs 12140 /12225, nct02043418). it is expected thereby to provide complementary information to the trials cher and predict on the long term development of (1) hiv-infected children according to age at arv initiation and (2) hiv exposed but not infected children, all compared with the control group of children uninfected, unexposed to hiv.

cognitive, motor and sensorial impairments associated to hiv infection have been and remain important concerns in children. the advent of arv has reduced the frequency and the extent of hiv-related encephalopathys, but literature suggests that more limited impairments remain (cher and predict trials). these neuro-cognitive disorders might constitute an important public health problem in sub-saharan africa where a high percentage of children born to hiv+ women live. nevertheless,the knowledge on their long-term consequences on children development in this context remains limited. data on the burden of cognitive, motor and sensorial impairment in resource-limited settings as well as on the interaction with other factors that could also impair children development are scarse. the pediacam cohort gives the opportunity to better understand the development of children born to hiv-infected mothers - infected by hiv or not - followed up from birth and living in sub-saharan africa.

Eligibility criteria:
inclusion criteria: * children included in the pediacam cohort and age 4 to 7 * parent or guardian written informed consent obtained exclusion criteria: -

Keywords: early art neurocognitive evaluation
thrombin generation test in patient with liver cirrhosis

Conditions: Cirrhosis

Summary: cirrhotic patients are patients with high morbidity and mortality, it is very important for determining the prognosis of these patients. the importance increases when these patients waiting for a liver transplant. the model for end-stage liver disease (meld) is a reliable measure of mortality risk in patients with end-stage liver disease. it is used as a disease severity index to help prioritize allocation of organs for transplant. meld uses the patient values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (inr) to predict survival. blood tests that we use today in daily practice to evaluate the coagulation system (pt, ptt) do not check actually the functioning of the system, but examine the level of clotting factors and therefore only verify that the side of anticoagulant of the equation and not the side of the procoagulant . to examine the coagulation system function tests have been developed, one of them is the thrombin generation. the purpose of the trial is to determine whether thrombin generation test can be a prognostic indicator in patients cirrhosis.


Eligibility criteria:
inclusion criteria: cirrhosis patient meld ( model for end-stage liver disease) above 12 exclusion criteria: pregnant women

Keywords: coagulation factor cirrhosis
a study of neutrexin plus leucovorin in the treatment of pneumocystis carinii pneumonia (pcp)

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Summary: to evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in patients with pneumocystis carinii pneumonia (pcp) who are refractory to or have demonstrated severe or life-threatening toxicities to standard therapies (e.g., tmp/smx or parenteral pentamidine).

patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate. patients are followed for 1 month.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * myelosuppressive or nephrotoxic agents at the discretion of the treating physician. patients must have: * pneumocystis carinii pneumonia (pcp) confirmed within 15 days prior to study entry. * serious intolerance and/or resistance to standard therapies (such as trimethoprim/sulfamethoxazole and parenteral pentamidine) during the course of therapy for the current episode of pcp, or a documented history of such intolerance during a prior episode. * consent of parent or guardian if less than 18 years of age. note: * pregnant women may enroll after the physician and patient have discussed the potential benefit versus risk. exclusion criteria patients with the following prior conditions are excluded: history of type i hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions due to trimetrexate glucuronate.

Keywords: trimetrexate pneumonia, pneumocystis carinii leucovorin drug therapy, combination acquired immunodeficiency syndrome
predictors of axial pain improvement after anterior cervical discectomy and fusion

Conditions: Neck Pain; Cervical Spondylosis; Cervical Disc Disease

Summary: neck pain is a common, multifactorial condition. in the case of degenerative cervical spinal disease, it can result from changes in the intervertebral discs, muscles, intervertebral joints, or sagittal imbalance. anterior cervical discectomy and fusion (acdf) is a currently widely accepted procedure for treating cervical degenerative spine disease, with a high patient satisfaction rate. in the current state of knowledge, it is not used for treating axial neck pain, but rather in cases of discopathy causing spinal myelopathy or cervical radiculopathy, in which neck pain often coexists or predominates. the current literature provides ample evidence of the significant effect of acdf in improving axial neck pain in the conditions mentioned previously. however, little information exists on which patients achieve improvement. the aim of this prospective study is to analyze the outcomes of acdf in patients with neck pain and to identify predictors of reduction in axial neck pain after acdf.


Eligibility criteria:
inclusion criteria: * ability to provide informed consent * patients who are qualified for one- or two-level acdf for the treatment of degenerative cervical pathology exclusion criteria: * previous cervical spine surgery * previous cervical spine trauma * other diseases causing neck pain include rheumatoid arthritis, lupus, polymyalgia rheumatica, myositis, seronegative inflammatory diseases, and fibromyalgia * drug abuse * myelopathy * spinal infection * vas neck pain score less than 3 (inability to achieve an mcid which is calculated as 2.5 for the vas scale)
acute effects of oxygen supplementation among ipf patients

Conditions: Idiopathic Pulmonary Fibrosis

Summary: idiopathic pulmonary fibrosis (ipf) is a disease characterised with significant morbidity and poor prognosis. dyspnoea and impaired exercise capacity are very common manifestations of the disease, and result in significant impairment of patients' quality of life. although hypoxemia is common among subjects with ipf, published data on the effects of supplementary oxygen therapy on specific clinical outcomes among these patients are currently few, while the existing data on the potential benefits of oxygen supplementation to treat exercise-induced hypoxemia, in this patient population, are even more controversial. based on the aforementioned, the purpose of this prospective, cross-over clinical trial is to investigate the acute effects of supplemental oxygen administration on the: a) exercise capacity, b) severity of dyspnea, c) cerebral oxygenation, b) muscle oxygenation, and e) hemodynamic profile, as compared to delivery of medical air (sham oxygen), in a group of patients with ipf, without resting hypoxemia, during steady state cardiopulmonary exercise testing (cpet).


Eligibility criteria:
inclusion criteria: stable ipf patients with no hospitalization, exacerbation or change in regular ipf medication during the last month, who do not present with resting hypoxemia, but manifest exercise induced hypoxemia exclusion criteria: 1. major contraindications for cpet conduction 2. not provision of informed consent -
acoustic analysis of the first babies crying in delivery room and adaptation to extra uterine life

Conditions: Premature Birth

Summary: interpreting the cry of new-borns is a real challenge not only for perinatal professionals but also for parents, who are confronted daily with those sounds. the description and the acoustic analysis of baby's cry can allow healthcare professionals to better adapt their care during the first months of life. thanks to an objective analysis method as acoustic analysis, the particularities of the first cry should provide us information on the quality of adaptation to ambient air life.

interpreting the cry of new-borns is a real challenge not only for perinatal professionals but also for parents, who are confronted daily with those sounds. the description and the acoustic analysis of baby's cry can allow healthcare professionals to better adapt their care during the first months of life. aiming for this objective, many studies have already been carried out on infants crying in the first months of life, in order to better understand their significance (pain, discomfort, hunger) and the mechanisms of recognition and discrimination by parents or listeners. various techniques are promising to characterize the acoustic space of cry (maximum frequency, intensity, harmonics, duration...). however, few studies have investigated the acoustic characteristics of the first cry of life in the delivery room. its intensity and characteristics are closely related to the laryngeal anatomy and respiratory capacity. thus, a vigorous cry with its own acoustic characteristics could be the witness of a good adaptation to extra uterine life, while a weak or plaintive cry should warn the caregiver on difficulties in this adaptation. thanks to an objective analysis method as acoustic analysis, the particularities of the first cry should provide us information on the quality of adaptation to ambient air life. the investigators hypothesize that the acoustic characteristics of the first cries of newborns recorded at birth are correlated with the criteria of extra uterine life adaptation (apgar score, ph and lactates collected from the umbilical cord), with the respiratory score (silverman) and with the early neonatal outcome (transfer to the intensive care unit).

Eligibility criteria:
inclusion criteria: * infant born between 37 and 42 sa * live infant at birth * parent who received informed written information about the study exclusion criteria: - emergency after childbirth (haemorrhage)

Keywords: crying apgar score infant behavior first cry delivery room extra uterine life
metoclopramide for migraine: a dose finding study

Conditions: Migraine

Summary: metoclopramide is an effective intravenous treatment for acute migraine attacks, but we do not know the best dose to administer. this study compares three different doses of metoclorpamide.

patients with acute migraine attacks are eligible for enrollment if they present to the emergency department of montefiore medical center. pain scores are assessed at baseline and every 30 minutes for two hours, and then again by telephone 48 hours after discharge

Eligibility criteria:
inclusion criteria: * acute migraine exclusion criteria: * secondary cause of headache * lumbar puncture * allergy or intolerance to study medication
gastrointestinal implications of voriconazole exposure

Conditions: Infection

Summary: voriconazole has better response rates, improved survival and less adverse side effects compared to other drugs for the treatment of invasive fungal infections making it a desirable therapeutic option for children. however, dosing is unpredictable in children and this leads to therapeutic failure. this study aims to understand the physiological differences between children and adults that leads to therapeutic failure of voriconazole in children.

voriconazole clearance in children (2-12 years old) is 3-fold higher and bioavailability is one half of adult values. an important gap in knowledge exists that explain the mechanisms that result in higher clearance and lower bioavailability of voriconazole and places children at a substantial risk for sub-therapeutic concentrations and treatment failures. preliminary data suggests that intestinal first-pass metabolism is responsible for the lower bioavailability in children, but not in adults. by inhibiting intestinal metabolism with grapefruit juice, the extent of the effect of intestinal first-pass metabolism on voriconazole pharmacokinetics can be determined. inpatient children at the children's hospital of philadelphia who are receiving oral voriconazole as standard of care will be enrolled in an open label, cross-over clinical trial to monitor plasma voriconazole levels after voriconazole administration with and without grapefruit juice to inhibit intestinal metabolism of voriconazole. the proposed research will elucidate the role of intestinal metabolism in the reduced oral bioavailability of voriconazole in children, which can be incorporated into a model simulation to guide accurate dosing.

Eligibility criteria:
inclusion criteria: 1. children aged 2-17 years old 2. receiving oral voriconazole as standard of care and at steady-state concentrations (defined as 72 hours from first-dose or 72 hours with no dose change) 3. informed consent/assent when appropriate exclusion criteria: 1. allergy or inability to receive the slushy solution, which will be prepared using commercially available frozen grapefruit juice concentrate, cherry syrup, and sprite. 2. receiving tacrolimus and/or cyclosporine, which are affected by the furanocoumarins, during study period 3. suspected or known hepatic dysfunction (defined as liver function tests measured at 3x upper limit of normal within the past 1 month, when measured as standard of care) 4. receiving renal replacement therapy (example peritoneal dialysis, hemodialysis, continuous veno-venous hemofiltration, continuous veno-venous hemodialysis) 5. receiving therapy with extracorporeal membrane oxygenation (ecmo) 6. patients with documented pancytopenia, diarrhea, mucositis, or active infection

Keywords: voriconazole absorption pharmacokinetic grapefruit juice bioavailability intestinal first-pass metabolism pharmacokinetics intestinal