Kornimate/medical-research-clean huggingface dataset:
a study of ly2605541 (insulin peglispro) and human insulin concentrations in fat tissue

Conditions: Diabetes Mellitus, Type 1

Summary: ly2605541 is an investigational drug being developed for the treatment of diabetes mellitus. this study is designed to understand how the body handles the investigational drug, and to measure the quantity of ly2605541 in fat tissue. the study has two parts. it involves intravenous (iv) infusion of the investigational drug and a procedure to measure concentrations in the fat tissue. both parts of the study will be conducted in participants with type 1 diabetes mellitus (t1dm). part a and b of the study might take up to 7 weeks to complete.


Eligibility criteria:
inclusion criteria: * have a diagnosis of type 1 diabetes mellitus (t1dm) based on medical history for at least 1 year prior to enrollment * have a c-peptide value ≤0.3 nanomoles per liter (nmol/l) at screening * have a serum creatinine value within normal limits at screening * have a haemoglobin a1c (hba1c) value ≤75 millimoles per mole (mmol/mol) (9.0%) at screening * have a body mass index (bmi) of 20.0-30.0 kilograms per meter squared (kg/m\^2), inclusive, at screening exclusion criteria: * have known or suspected allergies or hypersensitivities to ly2605541, human insulin, sinistrin, related compounds or any components of the formulations * are women who are pregnant or lactating * have an abnormal blood pressure for the population as determined by the investigator * have renal insufficiency or major renal disorders * have proliferative retinopathy or maculopathy * have lipodystrophy * have any wound healing disorder or are prone to keloid or hypertrophic scar formation * have results of screening prothrombin time (pt) and international normalized ratio (inr) tests that are significantly prolonged * have a fasting triglycerides value \> 4.52 millimoles per liter (mmol/l) (400 milligrams/deciliter (mg/dl)) * are receiving chronic systemic or inhaled glucocorticoid or have received such therapy within the 4 weeks before dosing * have a total daily insulin dose greater than 1.2 units per kilogram (u/kg) * regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing * regular use or intended use of non-selective beta blockers * regular use or intended use of monoamine oxidase (mao) inhibitors * are currently participating in a weight loss program or plan to do so during the course of the study * are unwilling to avoid excessive sun exposure, steam baths, saunas, and swimming during the study. sun cream should be used during sun bathing for the 6-month period following the study * are unwilling to avoid extensive consumption of food containing inulin during the study and in the 48-hour period leading up to the clamp
identification of autoantibodies and autoantigens in the cerebrospinal fluid of patients with spinal cord trauma

Conditions: Bone Marrow Failure; Trauma

Summary: the purpose of the study is to detect the presence of autoantibodies and autoantigens in cerebrospinal fluid early (\<48 hours) following spinal cord trauma. the study also aims to define the central or peripheral origin of autoantibodies by looking for their simultaneous presence at the blood level and to evaluate the prognostic value of the presence of autoantibodies within the cerebrospinal fluid, as well as on the initial clinical severity than on the recovery potential.


Eligibility criteria:
inclusion criteria: 1. patients with spinal cord injury dating back less than 48 hours 2. men or women over 18 years of age 3. patients benefiting from social protection 4. surgery performed within 48 hours of the trauma 5. informed and signed consent by the patient or trusted person exclusion criteria: 1. contra-indication to ensure surgical decompression within the first 48 hours following the trauma 2. coagulation disorders or any condition that may make the lumbar puncture risky (eg, history of lumbar surgery) 3. severe cranial trauma associated 4. history of autoimmune pathology 5. immunosuppressive therapy or long-term corticosteroid therapy 6. patients unable to comply with protocol requirements 7. person benefiting from legal protection (guardianship / curator) 8. person deprived of liberty 9. patient unable to express consent 10. pregnant women

Keywords: trauma spinal cord autoimmunity antibody
safety and efficacy of avp-923 in the treatment of levodopa-induced dyskinesia in parkinson's disease patients

Conditions: Dyskinesia; Parkinson's Disease

Summary: to evaluate the efficacy, safety, and tolerability of avp-923 capsules containing 45 mg dextromethorphan and 10 mg quinidine (avp-923-45) compared to placebo for the treatment of levodopa-induced dyskinesia (lid) in patients with parkinson's disease (pd).

proof-of-concept phase 2a, double-blind, randomized, placebo-controlled, crossover study.

Eligibility criteria:
inclusion criteria: * males and females 30 to 80 years of age, inclusive. * diagnosis of idiopathic pd meeting the united kingdom parkinson's disease society brain bank criteria. * levodopa-induced dyskinesia present greater than 25% of the day as per mds-updrs. * dyskinesia of at least moderate severity as per mds-updrs * amantadine and monoamine oxidase (mao) inhibitors must be discontinued at least three weeks prior to randomization. * subjects currently receiving anti-parkinsonian medications, including all levodopa preparations are eligible provided they have been on a stable dose of these medications for at least 1 month prior to randomization. * concomitant use of antidepressants such as selective serotonin reuptake inhibitors are allowed, provided the dose has been stable for at least 1 month prior to randomization. exclusion criteria: * subject had a prior surgery for pd except deep brain stimulation (deep brain stimulation must not have been performed within one year of screening) * hoehn and yahr score of 5 when "off". * subject with cognitive impairment and/or history of psychiatric manifestations or active hallucinations. * subjects with any history of complete heart block, qtc prolongation, or torsades de pointes. * subjects with any family history of congenital qt interval prolongation syndrome. * subjects with history of postural syncope, or any history of unexplained syncope within the last 12 months. * subjects with a history of substance and/or alcohol abuse within the past 2 years.

Keywords: levodopa dyskinesia parkinson's disease avp-923 dextromethorphan quinidine
residual symptoms after coronavirus disease (covid-19) in lithuanian population

Conditions: Post-Covid Syndrome

Summary: the aim of the study is to describe the post-covid-19 syndrome in lithuanian population regarding the remaining symptoms and their impact on physical functioning, work ability and needs of rehabilitation.

participants with suspected and confirmed cases of covid-19 infection will complete an anonymous online questionnaire for post-covid syndrome, i.e. symptoms lasting longer than 28 days after post-covid-19 syndrome. the online survey is developed to assess the health state before infection and residual symptoms lasting longer than acute covid-19 infection, influencing the functional activity and work ability. the needs of rehabilitation will also be assessed.

Eligibility criteria:
inclusion criteria: * older than 18 years age patients; * a history of covid-19 infection that was and was not positive for sars-cov-2 diagnostic or antibody testing * the duration of remaining symptoms is longer than 28 days * ability to fulfil internet-based questionnaire exclusion criteria: * ongoing covid-19 infection * other comorbidities requiring treatment or rehabilitation

Keywords: post-covid syndrome; rehabilitation
mhealth-supported coach

Conditions: Heart Disease Risk Factors

Summary: a randomised controlled trial to evaluate the effects of a personalised mhealth-supported coach programme in the middle-aged group with stroke risk.

aim: to evaluate the effects of a personalised mhealth-supported coach programme on the adoption of health-promoting behaviours in the middle-aged group, in comparison with usual care. design: a 24-month prospective two-arm, parallel-group, single-blinded, repeated-measure randomised controlled trial will be conducted. participants: people who aged between 40 and 64, mentally competent, have a non-laboratory interheart risk score (ihrs) of 10 or higher, communicable in chinese and free from stroke and transient ischemic attack (tia) or other cardiovascular disease will be eligible to the study. a total of 164 participants will be recruited through a district community centre and randomly assigned on 1:1 ratio to the intervention group or the control group. intervention: a theory-based mhealth-supported coach programme, including individual consultation sessions and a mobile application with a virtual sharing platform, is developed by a multidisciplinary team for the intervention group over three months, whereas the control group receives usual care.

Eligibility criteria:
inclusion criteria: * chinese ethnic * able to read chinese and communicate in cantonese/mandarin * with non-laboratory ihrs score 10 or higher exclusion criteria: * mentally incompetent * previously diagnosed with stroke, tia, mi, coronary heart disease, heart failure or atrial fibrillation * with eye or retinal disease * with terminal disease with an expected life expectancy less than six months * being pregnant * have enrolled in other lifestyle-based or exercise-based projects * do have mobile devices or internet service to access the mobile application

Keywords: primary health care
depuy trochanteric (atn) nailing clinical outcomes trial

Conditions: Femoral Fracture (Proximal)

Summary: the purpose of this study is to monitor trochanteric fracture healing and review the performance of the atn system.

proximal femoral fractures are among the most common femoral fractures. in the past plates and screws were often used to repair these fractures but this treatment had limitations including restricted weight bearing. intermedullary nailing is an alternative to plate and screw treatment. weight bearing is allowed and the procedure can be a less invasive. among intramedullary nailing complications are iatrogenic fractures that can be further divided into trochanteric and femoral shaft fractures. trochanteric fractures often heal without additional intervention however femoral shaft fractures usually require an additional surgical procedure to facilitate healing. this study will monitor fracture healing using clinical and radiographic evaluations of subjects with trochanteric fractures of the proximal femur treated with the atn system.

Eligibility criteria:
inclusion criteria: * ability to understand and willing to sign the approved consent form. * 18 years of age * skeletally mature * have stable or unstable proximal femur fracture, including pertrochanteric, intertrochanteric, high subtrochanteric or any combination of the ao proximal femur fracture classification exclusion criteria: * subjects with concomitant lower extremity injuries or multiple trauma that would interfere with normal hip fracture rehabilitation. * subjects who have isolated or combined medial femoral neck fractures. * subjects who are unwilling or unable to comply with a rehabilitation program or are unwilling or unable to be assessed for 1 year following surgery. * subjects who are pregnant or breastfeeding. * subjects who are a prisoner or a known alcohol or drug abuser. * subjects who have a prior surgical history in the affected hip, or conditions that may interfere with outcome or impede healing. * subjects who have an obliterated medullary canal or other conditions that may complicate the reaming process. * subjects who have evidence of active untreated infections that may spread to other areas of the body. * subjects who have a highly communicable disease or pathology that may limit follow-up. * subjects, who in the opinion of the clinical investigator, have an existing condition that indicates the subject is not a good candidate for the study. * subjects who are participating in another clinical investigation. * subjects known to have allergies to titanium, aluminum, vanadium. * subjects who are currently eligible for workman's compensation.

Keywords: proximal femoral fracture trochanteric fracture intramedullary nailing
immune function of infants with hiv

Conditions: HIV Infections

Summary: this observational study will evaluate data from infants born to hiv infected mothers in order to better characterize disease progression in early hiv infection.

the role of hiv-specific cytotoxic t-lymphocytes (ctl) in controlling viremia and protecting against disease progression following vertical infection may be dependent upon ctl functional responses as well as on the timing of detection, magnitude, and breadth of the responses. novel and sensitive assay systems (mhc-peptide tetramers, elispot assays, intracellular cytokine assays) have enhanced the detection and characterization of virus-specific ctl responses in the peripheral blood. this study will use these novel methods to examine the timing of detection, magnitude, specificity, and in vitro functional properties of hiv-specific ctl in infants; to evaluate the effects of potent combination antiretroviral therapy on hiv-specific ctl in infants; and to evaluate the immunogenicity of recombinant pox-based vaccines in hiv infected infants with prolonged viral suppression following early potent combination antiretroviral therapy. blood samples from infants born to hiv infected women will be obtained from infants enrolled in other hiv trials. generally, samples will be obtained at birth, week 1, and months 1, 2, 4, 6, 9, and 12.

Eligibility criteria:
inclusion criteria: * infants and children born to hiv infected women

Keywords: aids vertical transmission acute infection
myoarray and tclandscape analysis for the diagnosis of inflammatory myopathies

Conditions: Polymyositis; Dermatomyositis

Summary: the diagnosis of the different forms of inflammatory myopathies (polymyositis, dermatomyositis, inclusion-body myositis...) remains difficult which may lead to unappropriate patient care. objective 1 : to develop and evaluate the diagnostic value of a dedicated dna-array (myoarray) for adult-onset muscular diseases with focus on inflammatory myopathies. objective 2 : to evaluate the diagnostic value of t cell repertoire (tcland) analysis to distinguish different forms of inflammatory myopathies.


Eligibility criteria:
inclusion criteria: * indication of muscle biopsy for diagnostic purpose * written informed consent exclusion criteria: * vasculitis * coagulation disorder, impossibility to perform muscle biopsy

Keywords: myositis cdna arrays genes, t-cell receptor beta
covid-19 and lung ultrasound utility

Conditions: Covid19

Summary: ultrasounds are usually done by a specially trained health professional in the hospital or emergency department (ed) setting. using a novel single-probe device, the ultrasound can be plugged into an ios / android device. the purpose of this research is to assess the usefulness of lung ultrasound imaging, performed by the patient in the home setting for the management of the covid-19 disease using this novel highly-portable ultrasound.

this will be a prospective self-controlled design. the study subjects will receive a telehealth visit from a healthcare provider (hcp) to assess for any change in their covid-19 symptoms. the hcp will recommend the patient remain at home, or to go to an emergency department based on standard of care and clinical decision making. subsequently, the study subjects will receive a teleguidance session with a radiologist who is trained in lung ultrasound (lus) in order to obtain images of their chest. the physician performing lus remotely will report lus findings in a standard quality assurance (qa) document, including image quality, interpretation, and recommendations. this qa report will be study data and not shared with the patient. the two providers will be blinded, except when there is a disagreement between the telemed lus and clinical interview. the study staff will determine when this disagreement occurs. they will notify the study investigators and radiologist, who will then discuss and come to an agreement within 24 hours. if deemed concerning, they will then contact the hcp and unblind them as to the radiographic findings. there will be no delay in medical care advised by the subject's hcp. specifically, the nurse will inform the hcp by a phone call that the physician performing lus remotely found a significant change in lus findings. the hcp will then be given access to the lus report (as well as images if desired), and will review the decision to seek medical care with the telemed doctor.

Eligibility criteria:
inclusion criteria: * must be 18 years or older and able to provide a valid informed consent. * must have a nasal swab positive rt-pcr for covid-19 * must have access to wi-fi at home exclusion criteria: * subjects unwilling or unable to directly provide consent. * the following vulnerable study subject populations will not be eligible: prisoners, mentally impaired, or disadvantaged groups. * any condition deemed by the principal investigator, in his or her judgment, that may impact the subject's ability to meet the requirements necessary to collect the exam data required.
hcv tappt adherence study

Conditions: Hepatitis C

Summary: the goal of this non-inferiority clinical trial is to evaluate the efficacy of tappt, a novel digital medication companion solution, among individuals with hepatitis c virus (hcv) who are starting a daily oral medication regimen following standard of care in a clinical pharmacy setting. * the primary aim is to assess the non-inferiority of tappt with medication adherence, treatment completion, sustained virologic response (svr) assessment, and svr achievement rates. * the secondary aim is to assess the efficacy of tappt at enabling pharmacists to personalize treatment and management decision based on participants' reported barriers to adherence, care, and svr achievement. participants will download and utilize the tappt app to record adherence to oral medication. for the purposes of this study, adherence for participants in the intervention arm will be measured using a modified medication possession ratio (mpr) measure called medication tag scan ratio (mtsr). mtsr is defined as a percentage of the number of times participants scanned their passive tags versus the total of expected tag scans based on that participant's medication regimen and treatment period. upon study completion, a retrospective matched control will be established for the intervention group. historic data for the matched control's adherence, treatment completion, svr assessment, and svr rates will be compared to the intervention arm.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. hepatitis c virus (hcv) infection (denoted by positive hcv antibody and detectable hcv rna) 3. initiating oral hcv therapy with glecaprevir/pibrentasvir or sofosbuvir/velpatasvir 4. hcv treatment provided and managed by the clinical pharmacist at ui health 5. access to a mobile smartphone (iphone 7 or later; android release date 2012 or later) with reliable data and/or wi-fi access 6. ability to verbalize understanding of the study protocol in english 7. able and willing to provide informed consent in english exclusion criteria: 1. inability to speak and read english 2. inability or unwillingness to adhere to the study protocol 3. pregnant individuals 4. decompensated cirrhosis (child turcotte pugh class b and c); hepatocellular carcinoma; prior liver or kidney transplant no patient will be excluded because of gender, race or ethnic origin. the following populations will be excluded from the study: * adults 18 years of age and older who are unable or unwilling to consent * individuals less than 18 years old * pregnant individuals * prisoners
metabolic syndrome in pcos: precursors and interventions

Conditions: Polycystic Ovary Syndrome; Metabolic Syndrome

Summary: the purpose of this study is to investigate the metabolic effects of anti-androgens and oral contraceptive pills (ocps), compared with placebo, in the treatment of women with pcos. we hypothesized that controlling elevated androgen levels with either anti-androgens or ocps would produce improvement in metabolic markers in pcos women and would reduce their long term metabolic risk.

polycystic ovary syndrome (pcos) is one of the most common conditions of young women, and it is frequently associated with insulin resistance or metabolic syndrome (mbs). in addition, affected women have significantly elevated mean low-density lipoprotein (ldl) levels and an increased prevalence of at risk ldl levels, independent of obesity. we are directly testing the role of androgens in the metabolic abnormalities in pcos by examining the impact of direct androgen receptor blockade by anti-androgen medications and indirect suppression of androgen production through suppression of leutinizing hormone (lh) with oral contraceptive pills (ocps), compared with placebo, on visceral adiposity, circulating ldl levels, insulin secretion and sensitivity as measured by frequently-sampled iv glucose tolerance tests (fsigt) and oral glucose tolerance tests (ogtt), resting energy expenditure, and maximal aerobic capacity measurement. note: originally there were 2 additional study arm, metformin only and metformin + flutamide. these study arms were ultimately eliminated and were not included in analysis of baseline characteristics or endpoints.

Eligibility criteria:
inclusion criteria: * 6 periods or fewer per year * overweight * all ethnicities exclusion criteria: * diabetes * heart disease * chronic illness * regular smokers * current use of birth control pills, patch, ring, depo

Keywords: polycystic ovary syndrome metabolic syndrome pcos overweight infertility insulin resistance menstrual cycle
study of me-401 in subjects with relapsed or refractory indolent b-cell non-hodgkin's lymphoma

Conditions: Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

Summary: the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of me-401 in the treatment of japanese participants with relapsed or refractory indolent b-cell non-hodgkin's lymphoma and to continue administraion of me-401 to patients with relapsed or refractory b-cell nhl with collecting safety information


Eligibility criteria:
inclusion criteria: \[phase 1 study (dlt evaluation)\] * patients aged 20 years or older at the submission of the written informed consent form * patients with relapsed or refractory b-cell nhl * patients who have not undergone phosphatidylinositol 3-kinase inhibitor (pi3k) to date. * patients who have undergone bruton's tyrosine kinase (btk) inhibitors and have had no exacerbation during the use of btk inhibitors. * patients with ecog ps 0 or 1. exclusion criteria: \[phase 1 study (dlt evaluation)\] * patients who underwent any major surgical treatment within 4 weeks prior to the initiation of the investigational product. * patients with poorly controlled diseases. the followings are the examples but the diseases will not be limited to those. * patients in whom any of hbv antigen/antibody, hcv antibody, hiv antibody or htlv-1 antibody will be positive at screening test. * patients with active interstitial lung disease or a history thereof. * patients who have received the investigational products other than me-401, systemic chemotherapy or radiotherapy within 4 weeks prior to the initiation of me-401.