Kornimate/medical-research-clean huggingface dataset:
operant conditioning of reflex pathways to improve walking in individuals post-stroke

Conditions: Stroke; Post-stroke Hemiparesis; Foot Drop

Summary: the purpose of this study is to examine the changes in reflex pathways in the paretic ankle plantarflexors in individuals with post-stroke hemiparesis using operant conditioning. we are recruiting 5 individuals with chronic post-stroke hemiparesis with foot drop in the affected leg to participate in the reflex training procedure. the study involves 40 visits with a total study duration of about 4 months.


Eligibility criteria:
inclusion criteria: * at least 6 months following a single, unilateral stroke, resulting in hemiparesis. * ambulatory with or without assistive device, but must demonstrate a gait deficit which is indicative of foot drop from reduced activation of the tibialis anterior muscle. * able to follow verbal directions. * able to see icons on computer monitor (with or without corrective lenses) from at least 4 feet away. * all subjects will be adults at least 18 years old. * know history and current medication management for lower limb spasticity, if any. exclusion criteria: * no history of ear disease or balance problems outside of those caused by the stroke. * cerebellar stroke * no other neurological disease or injuries other than the stroke affecting the use of the legs and/or walking.
isp-001: sleeping beauty transposon-engineered b cells for mps i

Conditions: Mucopolysaccharidosis IH/S; Mucopolysaccharidosis IS

Summary: a first-in-human study using isp-001 in adult patients with mucopolysaccharidosis type i hurler-scheie and scheie.

this is a phase 1, first-in-human, open-label, single-arm study in which adult patients with mucopolysaccharidosis type i hurler-scheie and scheie are treated with autologous plasmablasts engineered to express α-l-iduronidase (idua) using the sleeping beauty transposon system (isp-001). this study will evaluate the safety and tolerability of isp-001.

Eligibility criteria:
inclusion criteria: * diagnosis of mucopolysaccharidosis type i hurler-scheie or scheie syndrome. * age ≥ 18 years at time of study registration. * creatinine clearance, calculated or measured directly, that is \>60ml/min/1.73m2. * ejection fraction ≥ 40% by echocardiogram. * must commit to traveling to the study site for the necessary follow-up evaluations. * must agree to stay \<45-minute drive from the study site for a minimum of 5 days after cell infusion. exclusion criteria: * known familial inherited cancer syndrome. suspected cases will be investigated, per the physicians discretion, using relevant genetic tests to determine presence of germline mutations. * history of b cell related cancer, ebv lymphoproliferative disease or autoimmune disorders. * evidence of active graft-vs-host disease. * underwent a previous hematopoietic stem cell transplant (hsct). * requirement for systemic immune suppression. * requirement for continuous supplemental oxygen. * any medical condition likely to interfere with assessment of safety or efficacy of the study treatment. * in the investigator's judgement, the subject is unlikely to complete all protocol-required study visits or procedures, including follow up visits, or comply with the study requirements for participation. other protocol defined inclusion/exclusion criteria may apply.

Keywords: mps ih/s mps is
antibody persistence and long term safety of a chikungunya virus vaccine (vla1553)

Conditions: Chikungunya Virus Infection

Summary: in this open-label phase 3b, single arm trial, persistence of antibodies and long term safety will be evaluated in up to 375 participants rolled over from trial vla1553-301 (nct number: nct04546724).

in this open-label phase 3b, single arm trial, persistence of antibodies and long term safety in up to 375 participants rolled over from trial vla1553-301 (nct number: nct04546724) these participants will have annual follow-up visits at months 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 after immunization. the primary objective of this trial will be to evaluate persistence of antibodies annually from 1 to 10 years after the single immunization with vla1553. the secondary objective is to evaluate long-term safety 6 months to 2 years after the single immunization with vla1553.

Eligibility criteria:
inclusion criteria: * individual participated in the vla1553-301 clinical trial; * participant has an understanding of the trial and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any trial-related procedures; * participant had immunogenicity blood samples taken at baseline (visit 1) and either day 29 (visit 3), day 85 (visit 4) or day 180 (visit 5) in trial vla1553-301 and was negative for neutralizing antibodies at baseline exclusion criteria: * participant presents with clinical conditions representing a contraindication to blood draws; * participant has donated blood or use of blood products prior 30 days of immunogenicity sampling; * participant has received an active drug with potential immunosuppressive action or investigational drug or device within a period of 30 days prior a trial visit; * participant has a known or suspected problem with alcohol or drug abuse as determined by the investigator; * participant has any condition that, in the opinion of the investigator, may compromise the participant's well-being, might interfere with evaluation of trial endpoints, or would limit the participant's ability to complete the trial; * participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities); * participant is a member of the team conducting the trial or in a dependent relationship with one of the trial team members. dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the trial.
efficacy of lu 31-130 in patients with schizophrenia

Conditions: Schizophrenia

Summary: the main purpose with the study is to explore the efficacy and safety of lu 31-130 in patients suffering from schizophrenia compared to a standard antipsychotic drug.

schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. antipsychotic drugs remain the cornerstone in the pharmacotherapy of schizophrenia. however, none of the available drugs is ideal, in particular because of their complex safety profile and the limited effectiveness against certain symptom domains. whereas positive symptoms respond to treatment the effects on negative symptoms and cognitive impairment are only very modest. thus present treatment options leave room for improvement and call for new, more effective pharmacotherapies for the treatment of schizophrenia. in the current study, patients suffering from schizophrenia and experiencing clinically significant symptoms of the disease will be included. eligible patients will be randomised to blinded treatment with either flexible doses of lu 31-130 or flexible doses of a standard antipsychotic treatment (olanzapine) for 12 weeks. the efficacy (including potential effects on cognitive symptoms) and the safety of lu 31-130 will be explored in comparison to olanzapine.

Eligibility criteria:
inclusion criteria: * the subject has a primary diagnosis of schizophrenia * the subject experiences clinically significant symptoms * the subject is willing to be hospitalized during the initial period of the study * the subject has normal serum values of parameters associated with liver function

Keywords: schizophrenia antipsychotic olanzapine lu 31-130
pharmacokinetic study comparing salmeterol/fluticasone easyhaler and seretide diskus

Conditions: Asthma

Summary: pharmacokinetic study comparing salmeterol/fluticasone easyhaler products and seretide diskus 50/500 µg/inhalation; a randomised, open, single centre, single dose, crossover study in healthy subjects


Eligibility criteria:
inclusion criteria: * written informed consent obtained * good general health ascertained by detailed medical history, and laboratory and physical examinations exclusion criteria: * evidence of a clinically significant cardiovascular, renal, hepatic, hematological, gi, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years * any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study. as an exception paracetamol and ibuprofen for occasional pain are allowed * known hypersensitivity to the active substance(s) or the excipient (lactose, which contains small amounts of milk protein) of the drug * pregnant or lactating females
medication adherence in heart failure after hospitalisation

Conditions: Adherence, Medication; Heart Failure

Summary: to explore medication adherence in patients who were hospitalised due to heart failure.


Eligibility criteria:
inclusion criteria: * diagnosis of heart failure * hospitalisation due to heart failure in the past two years exclusion criteria: * not speaking german * cognitive impairment
banding ligation with carvedilol versus carvedilol for the prevention of first bleeding

Conditions: Variceal Bleeding

Summary: endoscopic variceal ligation (evl) and carvedilol have been documented to be effective in prophylaxis of the first bleeding. the efficacy \& safety of combining evl and carvedilol in prophylaxis of the first bleeding is still unknown. this study aims to investigate the value of combination therapy.

combination of evl and β-blocker has been proven effective in the prevention of variceal rebleeding . however, our previous study showed that combination of evl and nadolol do not have enhanced effect in the prophylaxis of 1st variceal bleeding as compared with nadolol alone . one of the drawbacks of evl is esophageal ulcer. on the other hand ,carvedilol, an anti-α beta-blocker, has been proven to be more effective than propranolol in the reduction of portal pressure. carvedilol has been proven to be more effective than evl in the prevention of 1st variceal bleeding. the investigators thus conduct a multicenter trial to evaluate whether combination of evl and carvedilol could be more effective than carvedilol alone in the prophylaxis of 1st esophageal variceal bleeding . the goal of patients receiving evl is to reduce variceal size, not variceal obliteration, in anticipation for fewer sessions required for each patient and fewer possibility of esophageal ulcer bleeding.

Eligibility criteria:
inclusion criteria: 1. cirrhosis with esophageal varices are larger than f2. 2. no history of variceal bleeding. 3. in three months have not implemented preventive esophageal variceal ligation. (4)age 20yrs～75yrs. exclusion criteria: 1. association with hcc or other cancers . 2. refractory ascites. 3. jaundice, bilirubin \> 5mg/dl. 4. encephalopathy. 5. cr.\>3mg/dl. 6. a-v,block bradycardia (pr \< 60/mim). 7. hypotension systolic blood pressure\<95/mmhg . 8. refusal to participate. 9. carvedilol allergy 10. second degree-third degree atrio-ventricular block. 11. bradycardia. 12. wpwsyndrome 13. hypotension 14. psychogenic shock. 15. asthma. all the patients are randomized based on a random number.

Keywords: carvedilol banding ligation with carvedilol the efficacy & safety of combining evl and carvedilol in prevention of first variceal bleeding
intravenous contrast computed tomography versus native computed tomography in patients with acute abdomen and impaired renal function

Conditions: Acute Abdomen; Radiocontrast Nephropathy

Summary: computer tomography (ct) is the primary imaging option for acute abdominal pain in adults. intravenous (iv) contrast media is used to improve the ct quality. in patients with impaired renal function, post-contrast acute kidney injury (pc-aki) has remained a significant concern. modern retrospective studies have shown no association between worsened baseline renal function and iv-contrast ct. however, no randomised controlled trial has been done to conclude this. the incaro (intravenous contrast computed tomography versus native computed tomography in patients with acute abdomen and impaired renal function) trial is a multicentre, open-label, parallel group, superiority, individually randomised controlled trial comparing iv-contrast enhanced ct to native ct in patients with impaired renal function. patients requiring emergency abdominal or body ct with egfr 15-45 ml/min/1.73 m2 are included in the study. the primary outcome is a composite outcome of all-cause mortality or renal replacement therapy within 90 days from ct.


Eligibility criteria:
inclusion criteria: * patients requiring emergency abdominal or body ct with egfr 15-45 ml/min/1.73 m2 exclusion criteria: * age less than 18 years * pregnancy * egfr less than 15 or more than 45 ml/min/1.73 m2 * renal replacement therapy within 30 days prior enrolment * ct with iv contrast less than 72 hours prior enrolment * suspicion of vascular occlusion, dissection or bleeding (i.e. need for iv-contrast) * ct needed without iv-contrast to detect or rule out ureteral stone * iv contrast allergy * inability to give written consent.
exercise based on proprioceptive neuromuscular facilitation in older individuals

Conditions: Functional Disability; Dynapenia; Sarcopenia in Elderly

Summary: the goal of this clinical trial was to determine whether an intervention using resisted sit-to-stand and walking exercises with proprioceptive neuromuscular facilitation (pnf) techniques improved gait and sit-to-stand in older individuals with poor functional capacity compared to a control group that performed the same activities, but without manual resistance. the main questions it aimed to answer were: did an exercise program based on the pnf concept improve functional capacity and strength performance? was there a difference between an exercise program with or without pnf techniques on functional capacity and strength in older adults? researchers compared the effects of an exercise program based on the pnf concept to a similar exercise training without manual resistance on functional capacity and strength performance. participants participated in an intervention using resisted sit-to-stand and walking exercises with or without pnf and performed functional capacity and strength tests at the beginning and end of the intervention.

the proposal consisted of investigating an exercise intervention based on the proprioceptive neuromuscular facilitation concept (pfng), compared to a control group (cg), which performed the same exercises as pnfg under a therapist's supervision, but without resistance imposed by the therapist's hands as in pfng, in older individuals. before data collection, individuals participated in a familiarization procedure for each test. each specific test was conducted on the same equipment with identical participant/equipment positioning. functional assessment and intervention were conducted at the participants' residences. the cg intervention consisted of the same activities carried out in the pnfg during stages 1 and 2, for the same amount of minutes, sessions, and weeks. however, the cg intervention did not include specific techniques and basic principles (i.e., approximation and optimal resistance) and procedures of the pnf concept. the activities were instructed and supervised by a trained professional through verbal commands. the professional was in a stand-by assistant position to prevent accidents. each intervention lasted 30 minutes and took place twice a week, for 4 weeks, totaling 8 meetings. the interventions were supervised by researchers blinded to pre-intervention assessment results and randomly assigned for both pnf and control groups. the researchers responsible for the interventions were physical therapists with basic ipnfa® (international proprioceptive neuromuscular facilitation association) instruction.

Eligibility criteria:
inclusion criteria: * short physical performance battery score lower than 10 points. exclusion criteria: * neurodegenerative diseases; * illnesses contraindicating exercise (e.g., uncontrolled arrhythmias, acute myocardial infarction); * unstable medical condition.

Keywords: frailty proprioceptive neuromuscular facilitation gait balance sit-stand functionality
evaluation of clearllab leukemia and lymphoma panels

Conditions: Leukemia-Lymphoma

Summary: multi-center study of specimens from subjects presenting to the flow cytometry laboratory as part of their standard of care for hematological diseases work-up.

multi-center study of specimens from subjects presenting for flow cytometry immunophenotyping as part of their standard of care for hematological diseases work-up. residual specimens will be tested using the clearllab panels to determine the presence or absence of an abnormal phenotype and compare results to clinical impression (hematological malignancy or non-malignancy).

Eligibility criteria:
inclusion criteria: * residual samples from patients with hematological abnormalities being evaluated by flow cytometry for the presence or absence of an abnormal population associated with a hematological malignancy. all subjects of any ethnicity, age and racial background will be included. exclusion criteria: * specimens and/or spent samples that are visibly hemolyzed * specimens and/or spent samples that are visibly clotted * specimens and/or spent samples collected in k2edta anticoagulant older than 24 hours from time of collection * specimens and/or spent samples collected in heparin or acd anticoagulant older than 48 hours from time of collection * samples with insufficient volume to complete the protocol tests

Keywords: hematological diseases
tracking mood and language change across a phone-based mindfulness intervention

Conditions: Depression, Anxiety

Summary: the objective of this study is to administer a brief, phone(voice)-based training program in mindfulness (or control task of active listening to narrated articles) to older adults who receive primary care services at nm. older adults represent a population that is at risk for depression and anxiety, especially during the current covid-19 pandemic and the social isolation it entails. many older adults also possess relatively low access to application-based mindfulness training opportunities. the monitoring aims are: 1. to determine whether the experimental intervention (mindfulness training) performs better than a control task (active listening) in improving mood assessed using the profile of mood states (poms) and/or anxiety assessed using the state-trait anxiety inventory (stai). 2. to determine whether the experimental and/or control intervention is associated with quantified changes in language use (e.g., frequency of negative word use), which may or may not also be associated with changes in mood and anxiety.


Eligibility criteria:
inclusion criteria: 1. patients part of the northwestern medicine geriatrics practice, or northwestern feinberg school of medicine ecmh program. 2. english-speaking; and 3. able to verbally consent exclusion criteria: patients with dementia or otherwise not meeting inclusion criteria
skin tape transcriptome methods in children

Conditions: Atopic Dermatitis

Summary: this pilot study will evaluate new methods for the collection, storage, shipment, and rna extraction of skin tape specimens from children with atopic dermatitis (ad) that will facilitate the multi-center sunbeam birth cohort study. additionally, this pilot study will test new methods for the generation of whole transcriptome sequencing data from skin tape rna and whether these data reflect the transcriptional state of the skin in health and disease.


Eligibility criteria:
inclusion criteria: 1. able to provide informed consent/assent. 2. male or female, 4-12 years of age (prepuberty) inclusive at the time of consenting 3. participant must be either: 1. active atopic dermatitis with two areas of non-lesional ad within 5 cm of the measured lesional area within the same region. or 2. .no personal history or current manifestations of ad, food allergy, asthma, allergic rhinitis, and no positive prick or blood testing for allergen (based on self-report); and no evidence of dry skin or other skin condition exclusion criteria: 1. unable to provide consent or comply with the protocol 2. presence of any skin condition that might compromise the stratum corneum barrier in infants and young children (e.g., ichthyosis, psoriasis, extensive seborrheic dermatitis, scabies) 3. history of any skin reaction to tape, or adhesives 4. past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. 5. use of any topical product (e.g., emollient, topical corticosteroids, topical immunomodulatory agents, topical antibiotics) on the area(s) to be tested within 24 hours before the study visit.
small-incision open cholecystectomy or laparoscopic cholecystectomy for gallbladder disease

Conditions: Biliary Tract Diseases; Gallbladder Diseases; Cholecystitis; Cholecystolithiasis

Summary: the trial compares minilaparotomy (small-incision) cholecystectomy with (key-hole) laparoscopic cholecystectomy by randomly allocating patients with gallbladder disease to two groups of surgeons, each group being trained for one of the two methods.

small-incision open cholecystectomy (minilaparotomy) for gallbladder disease has been proven superior to conventional open cholecystectomy. however, it was rapidly overshadowed by laparoscopic cholecystectomy when the latter method was introduced. today, some 25% of all gallbladder surgery is done with the conventional open cholecystectomy, often on elderly and frail patients. previous trials comparing minilaparotomy and laparoscopic cholecystectomy have been hampered by surgeons´ different expertise with the two methods. these studies indicate that operation time is shorter and that health care cost is lower for minilaparotomy compared to laparoscopic cholecystectomy, but hard data are scarce. the objective of the present trial is to randomize eligible patients to two groups of surgeons, well trained in either minilaparotomy cholecystectomy or laparoscopic cholecystectomy. surgeons in the minilaparotomy group will consider extension of the incision when necessary, and surgeons in the laparoscopic group will aim for laparoscopic cholecystectomy with conversion to open cholecystectomy if this is indicated. the design of the study allows wide inclusion criteria for participants, a cost-utility approach in the analysis, and a high external validity of the conclusions reached. comparison: minilaparotomy cholecystectomy compared to laparoscopic cholecystectomy for gallbladder disease.

Eligibility criteria:
inclusion criteria: 1. cholecystectomy is considered the best available treatment. 2. the patient understands trial information and is capable of making a decision after having received information. 3. the patient wants to undergo cholecystectomy and accepts participation in the trial. exclusion criteria: 1. age below 18 years. 2. the patient is unable to understand trial information. 3. competence for both trial groups are lacking when a patient is randomized. 4. the cholecystectomy is part of a more extensive operation (e.g., pancreaticoduodenectomy). 5. the indication of cholecystectomy is proven or suspected cancer of the gallbladder.

Keywords: gallbladder diseases gallstones cholecystectomy minilaparotomy laparoscopy