Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of rayaldee for treating mild to moderate covid-19

Conditions: COVID-19; Coronavirus; SARS-CoV2 Infection

Summary: this is a phase 2, single or multi-center, randomized, double-blind placebo-controlled study to evaluate the safety and efficacy of rayaldee (ctap101 capsules) to treat adult subjects with mild to moderate covid-19 who test positive for sars-cov-2.


Eligibility criteria:
inclusion criteria: 1. male or female ≥18 years of age 2. confirmed within the past 3 days to have sars-cov-2 infection as evidenced by a positive nasopharyngeal swab test using rt-pcr or any substitutable fda-authorized diagnostic test 3. confirmed to have only mild or moderate covid-19 based on the first of the patient reported scores obtained during screening which meets the criterion a flu-pro plus© score of ≥ 1.5 for each of the chest/respiratory and body/systemic domains, and the absence of clinical signs indicative of more severe disease (eg, oxygen saturation \ 30 bpm) 4. represents on self-assessment that the current covid-19 symptoms are not consistent with usual health and that they are the same or worse than on the previous day 5. willing to limit the use of vitamin d therapies or supplements except for normally fortified food products (eg, milk) during the course of the 6-week study 6. must demonstrate the ability to comply with all study requirements 7. must be without any disease state or physical condition that might impair evaluation of safety or which, in the investigator's opinion, would interfere with study participation. exclusion criteria: 1. clinical signs indicative of severe or critical covid-19 disease (eg, oxygen saturation \ 30 bpm) 2. pregnant or lactating women who are breastfeeding 3. use of systemic glucocorticoid medications in the last six months 4. recent history (previous 12 months) of primary hyperparathyroidism, kidney stones, hypercalciuria and/or hypercalcemia 5. history of a chronic granuloma-forming disease (eg, sarcoidosis) 6. history of tuberculosis or histoplasmosis 7. history of chronic liver disease 8. history (previous 12 months) of cardiac event indicative of chronic cardiovascular diseases including congestive heart failure, poorly controlled hypertension and arrhythmias 9. history in the past five years of multiple myeloma or carcinoma of the breast, lung or prostate 10. any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of vitamin d or 25-hydroxyvitamin d (25d) (eg, small bowel resection, history of crohn's disease or ulcerative colitis) 11. ongoing treatment with thiazide diuretics 12. history of hyperphosphatemia, hyperuricemia and gout 13. renal impairment measured as egfr\< 15 ml/min/1.73m² on serum creatinine in the last three months 14. serum calcium ≥9.8 mg/dl in the last three months 15. evidence of existing or impending dehydration 16. known or suspected to have hypersensitivity to any of the constituents of the study drug 17. currently participating in, or have participated in, an interventional/investigational study within 30 days prior to study screening.
busulfan and cyclophosphamide followed by allo bmt

Conditions: Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Myelodysplastic Syndrome

Summary: this is a treatment guideline to allow routine clinical data to be collected and maintained in oncore (clinical database) and the university of minnesota blood and marrow database as part of the historical database maintained by the department.

this is a single arm trial to evaluate the efficacy of busulfan and cyclophosphamide followed by an allogeneic hematopoietic stem cell transplant (hsct) in the treatment of hematological malignancies. the intent of this study is to provide a protocol that will use unmanipulated allogeneic hematopoietic stem cells from related and unrelated donors after a common preparative regimen.

Eligibility criteria:
inclusion criteria: * diagnosis of acute lymphoblastic leukemia (all), acute myeloid leukemia (aml) or myelodysplastic syndrome (mds) and current in complete remission meeting one of the following: * \<45 years of age who are at least 6 months after initial hematopoietic stem cell transplant (hsct) * \<45 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (tbi) containing preparative therapy * karnofsky performance status \>70% or if \ 50 * adequate major organ function including: * cardiac: left ventricular ejection fraction \>45% by echocardiogram (echo/muga) * renal: creatinine clearance \>40 ml/min/1.73m\^2 * hepatic: no clinical evidence of hepatic failure (e.g., coagulopathy, ascites) * an acceptable source of stem cells according to current university of minnesota bone marrow transplant program guidelines. acceptable stem cell sources include: * hla-matched related or unrelated donor bone marrow (6/6 or 5/6 antigen match) * hla-matched related or unrelated donor peripheral blood stem cells * related or single or double unrelated donor umbilical cord blood (6/6, 5/6 or 4/6 match) * women of childbearing age must have a negative pregnancy test and all sexually active participants must agree to use effective contraception during study treatment * written consent (adult or parent/guardian) exclusion criteria: * eligible for tbi containing preparative regimen * active uncontrolled infection within one week of study enrollment * pregnant or lactating female
evaluation of metabolomic analysis in early diagnosis of als

Conditions: ALS

Summary: this project is expected to answer the question of interest assays of metabolites in the csf as a tool for early diagnosis and should show whether it is possible or not to use such markers in the blood or urine. these studies should also help shed light on the pathophysiological original early clinical disease. while als appears to be more a clinical syndrome that pathophysiological entity unique metabolic abnormalities identified could help identify mechanisms disrupted in which therapeutic interventions will be possible.

a blood test that would allow the diagnosis 1. to reduce the time between the first signs and diagnosis in als patients for therapeutic treatment earlier and 2. to exclude rapidly non als in their avoiding unnecessary investigations and anxiety of being infected with a terrible prognosis disease. it is currently accepted that neurodegenerative diseases such as als begin before the first clinical signs and the patient could benefit from a more efficient care if it was early. conduct a prospective study with 400 patients. the secondary objectives are: 1. attempt to improve the predictive power of markers assays by adding new parameters 2. to check whether the assayed molecules in other environments more accessible (blood, urine) would provide equivalent diagnostic power of those assayed in the csf 3. identify metabolic pathways disrupted early that could be related to the pathogenesis of neurodegeneration.

Eligibility criteria:
inclusion criteria: * age 30-80 * consent signed * affiliation to a social security organism exclusion criteria: * patients treated with riluzole * enrollment in an other study

Keywords: als spinal cerebrospinal fluid urine serum diagnosis
detection of microdeletions in the azoospermia factor (azf) regions in infertile male patients

Conditions: Azoospermia or Severe Oligozoospermia

Summary: in this prospective study, we used multiplex ligation-dependent probe amplification and next-generation sequencing technology to detect azf microdeletion types accurately in selected genetic locus, and made correlation analysis with clinical treatment results.

infertility has plagued more than 10% of the world's couples of childbearing age, of which male factors account for half. there are many causes of male infertility, including infection, genital malformations, immune dysfunction, varicocele, erectile dysfunction, drug side effect and chromosomal abnormality. microdeletion of azoospermia factor (azf) in the long arm of the y chromosome is one of the main genetic factors leading to dyszoospermia. the incidence of azf microdeletions is 2%\~19.4% among male infertile patients in asia, which is related to the inclusion criteria, sts site selection, population and genetic background. at present, there are large numbers of studies on azf microdeletions in male infertility, and provide rich information on male infertility. however, as the main means of detection is multiplex pcr-capillary electrophoresis method, which usually detects sequence-tagged sites(sts) such as azfa-sy84，sy86，azfb-sy127，sy134，azfc- sy1191, sy1291, sy1189,sy254 and sy255, information on other loci is still lacking. in addition, the shortcomings of this method include false positive and false negative results caused by fuzzy electrophoresis strip or pollution and the presence of high repetition and a large number of palindrome in complex azf region. because some microdeletions can't be detected it is difficult to make an accurate judgement on the fertility of the patients. this study will use multiplex ligation-dependent probe amplification and ngs method to improve the detection rate of azf microdeletion, and analyze the microdeletion data and the patient's fertility results, so as to improve genetic counseling. a total of 5000 male infertility patients will be enrolled. at least 1000 parents and 1000 normal fertile men will be asked to donate their peripheral blood for dna. in addition, in patients with azoospermia or severe oligozoospermia, the overall deletion rate of azf is about 8.77% (1.75%-24.70%), so there are other unknown genetic factors leading to azoospermia or severe oligozoospermia. this study will also try to make a preliminary study of these factors.

Eligibility criteria:
inclusion criteria: -male patients diagnosed with azoospermia and severe oligozoospermia. exclusion criteria: 1. klinefelter syndrome ; 2. structural chromosome aberrations； 3. obstructive anspermia; 4. male infertility caused by endocrine factors; 5. do not meet requirements for acquisition, processing and preservation of samples； 6. after sampling, it doesn't conform to the standard of quality control, or other experimental conditions that don't meet the test requirement； 7. unable to obtain patient history;
positive psychology interventions in individuals with chronic pain and spinal cord injury

Conditions: Chronic Pain; Spinal Cord Injury

Summary: background: chronic pain is one of the most burdensome potential consequences of a physical disability, such as spinal cord injury (sci). estimates of the incidence of chronic pain in sci range between 65 - 80%. a recent pilot-study of a computer-based tailored positive psychology intervention showed a significant reduction in pain intensity, pain interference, pain catastrophizing and depression and an enhancement of subjective well-being and control over pain in persons with chronic pain secondary to a physical disability. study objective: objective 1: to determine the efficacy of a tailored positive psychology intervention (t3p) in a community-based, single-blind, randomized, controlled, parallel group trial on subjective well-being and pain in individuals with chronic pain secondary to sci. hypothesis 1: t3p will result in (1) greater immediate and long-lasting increase in subjective well-being, and perceived control over pain and (2) greater immediate and long-lasting decrease in depression, pain intensity, pain interference and catastrophizing, relative to an active control treatment. specific aim 1: to increase the understanding of the mechanisms underlying t3p by determining potential mediation effects. hypothesis 2: (1) pain catastrophizing and pain control mediate the effect of t3p on pain intensity, and (2) positive and negative affect mediate the effect of t3p on life satisfaction and depression. objective 2: to identify for whom t3p is most effective by exploring potential moderator effects. study design: the proposed study is a single-blind, randomized, controlled trial with a parallel group design to determine the effects and mechanisms of t3p in a swiss community sample of persons with chronic pain secondary to sci.


Eligibility criteria:
inclusion criteria: * registered in swiss spinal cord injury cohort study (swisci) * individuals who experience an average disability-related pain intensity of ≥ 4 on a 0-10 numeric rating scale in the past week * individuals who experience pain at least half the days in the past four weeks, and * individuals are able to speak, read and write german exclusion criteria: * individuals who report current participation in any psychotherapy (e.g. psychotherapy, hypnosis, biofeedback) once a month or more often * individuals who report hospitalization for psychiatric reasons within the past year * individuals with a severe cognitive impairment defined as one or more errors on a six-item screening
screening for preeclampsia with various markers in low-risk pregnancy populations

Conditions: Preeclampsia

Summary: for the prediction of late-onset preeclampsia (pe) in low risk women, the investigators established a cut-off value for sflt-1/plgf ratio and evaluated the combination models of elecys, second trimester uterine artery (uta) doppler, and fetoplacental proteins for down syndrome screening.

a prospective study was carried on in cha hospital. serum samples for down syndrome screening were assayed to estimate pregnancy-associated plasma protein-a (papp-a), alpha-fetoprotein , unconjugated estriol, human chorionic gonadotrophin , and inhibin-a. women screened for down syndrome were offered uta doppler at 20-24 weeks of gestation and then collected serial serum samples for sflt-1/plgf ratio at two time points (24-27 and 34-37 weeks' gestation).

Eligibility criteria:
inclusion criteria: * women considered as a potential participant in this research were patients regularly visited at the prenatal care of cha hospital in seoul, korea exclusion criteria: * early onset and cases not to measure the sflt/plgf ratio and other markers * twin pregnancy * chronic hypertension * prior history of preeclampsia * pregestational diabetes mellitus * gestational diabetes mellitus * patients delivered before 35 weeks of gestation * preeclamptic patients with onset before 35 weeks of gestation * patients with body mass index 25kg/m2 or greater * maternal age 40 years older

Keywords: preeclampsia
conservative or operative treatment of fractures in the neck of the 5th metacarpal bone

Conditions: Fractures of the Neck

Summary: a multi-site randomized controlled trial where patients are allocated to operative treatment or conservative treatment of fractures of the neck of the 5th metacarpal bone. the study goal is to identify which degree of angular displacement in the fracture that requires operative intervention.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age with fractures of the neck of the 5th metacarpal bone exclusion criteria: * less than 30 degrees of volar angulation in the fracture * rotational deformity * pseudoclawing * intra-articular involvement * ad latus displacement more than one half of a bone width * concomitant fractures or soft tissue damage * admittance more than 14 days after injury * non-compliant patient (language, drugs, tourist) * patient who refuses to participate in the study

Keywords: fracture 5th metacarpal bone bouquet pinning fractures of the neck of the 5th metacarpal bone
anatomy-based fitting in unexperienced cochlear implant users

Conditions: Cochlear Implants; Sensorineural Hearing Loss

Summary: severe to profound hearing loss affects 0,8% of the global population. for these people, a conventional hearing aid often does not provide sufficient benefit. however, these people can benefit from a cochlear implant (ci). a ci needs to be individually programmed (fitted) for each recipient. a fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. at present, most ci recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. in this study, a fitting strategy based on the post-operative ct scan, that will allow the audiologist to set a frequency-band distribution for ci fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s) * post-operative computed tomography (ct) scan of the ci electrode available * pre-operative result of pure-tone audiometry, speech test in quiet and in noise available * subject implanted with med-el cochlear implant(s) * subjects received a flex28, flexsoft or standard electrode * subject planned to receive a sonnet 2 or rondo 3 audio processor on the newly implanted side * audio processor not yet activated on the newly implanted side * the most apical active electrode contact has to be inserted at least 450° * minimum of 10 active channels can be activated * fluent in the language of the test centre * signed and dated informed consent form (icf) before the start of any study-specific procedure exclusion criteria: * lack of compliance with any inclusion criteria * electric acoustic stimulation (eas) user (user of an eas audio processor) * implanted with c40+, c40x and c40c * implanted with an auditory brainstem implant (abi) or split electrode array * anything that, in the opinion of the investigator, would place the subject at increased risk or pre-clude the subject's full compliance with or completion of the study
high gastrointestinal bleed risk outcomes in patients with non-valvular atrial fibrillation (nvaf) in france

Conditions: Atrial Fibrillation

Summary: this study is a retrospective analysis of observational cohorts using data from prospectively collected administrative/claims data to investigate treatment patterns, and safety and effectiveness outcomes in patients with nvaf with high risk of gastrointestinal bleed who initiate anticoagulant treatment with a vitamin-k antagonists (vkas) or direct-acting oral anticoagulants (doacs).


Eligibility criteria:
inclusion criteria: patients covered by the french national health insurance general scheme with at least one reimbursement of ac treatment (apixaban, rivaroxaban, dabigatran, or vkas) aged ≥18 years as of the index date with a diagnosis of atrial fibrillation (af) prior to or on the index date with at least one risk factor for gastrointestinal bleeding exclusion criteria: patients with different types of ac treatment at the index date patients with a diagnosis or procedure code indicative of rheumatic mitral valvular heart disease or valve replacement procedure individuals with a diagnosis of vte during the 12 months prior to or on the index date

Keywords: eliquis anti-coagulation bleed stroke
befast or bestrong: brain change after fun athletic sports-skill training or brain change after strength training focusing on gait

Conditions: Cerebral Palsy

Summary: the purpose of this study is to compare a motor learning (ml)-based gait-related training intervention to a functional lower limb strength training intervention, with a concurrent evaluation of functional, neural and participation outcomes for children and youth with cerebral palsy (cp). this study is a two-group, parallel arm rct in which twenty-two children with cp in gmfcs levels i-ii will be randomly allocated to a 6-week, 16 session program of: (i) ml based gait training or (ii) lower limb strength training. outcome assessments occur pre/post/4-months post-intervention.


Eligibility criteria:
inclusion criteria: * 7-17 years old * diagnosis of hemiplegic or diplegic cerebral palsy * gmfcs level i-ii * able to follow testing and motor imagery instructions * able to actively participate in a minimum of 45 minutes (min) of physical activity * show evidence of independent dorsiflexion of both ankles * able to commit to attendance of sessions two to three times weekly for six weeks. exclusion criteria: * orthopaedic surgery within the last 9 months (muscle) or 12 months (bone) * botulinum toxin-a (btx-a) injections to lower limb in the last 4 months * inability to put btx-a on hold during trial * severe spasticity (may be a contraindication for neuroimaging procedures) * seizure disorder (if not fully controlled by medication for 12 months) * not prepared or unable to discontinue any formal lower limb therapy intervention or physical activity program during the trial * involved in another intervention study * standard mri contraindications (e.g., magnetic implants, inability to lay still, claustrophobia etc.)
treatment with metformin in chinese children with alport syndrome

Conditions: Alport Syndrome; Metformin

Summary: this single-center, prospective, double-blind randomized placebo-controlled trial will evaluate the efficacy and safety of metformin in chinese children with alport syndrome who have received (and continue to receive)) acei/arb.


Eligibility criteria:
inclusion criteria: * (1) the diagnostic of alport syndrome-hematuria with or without proteinuria meets one or more of the following 4 items: i) immunofluorescence staining of the α5 (iv) chain of the glomerular basement membrane was abnormal; ii) electron microscopy of renal biopsy showed diffuse changes in the glomerular basement membrane; iii) there was one pathogenic variant in the col4a5 gene or two pathogenic variants in the col4a3/col4a4 gene; iv) family history of alport syndrome. (2) age is older than or equal to 10 years old. (3) the 24-hour urine protein quantification was greater than 150mg and the urine microalbumin-creatinine ratio was greater than 30 mg/g. (4) the estimated glomerular filtration rate (24-hour creatinine clearance) was greater than 45 ml/min/1.73m2. (5) accept the maximum tolerated dose of renin-angiotensin-aldosterone system blockers (blood pressure in the clinic was in the 50th percentile of the same age, same sex and same height but greater than 90/60mmhg, blood potassium was normal, and the increase of blood creatinine did not exceed 30%) for at least 3 months. exclusion criteria: * (1) vitamin b12 deficiency was uncorrected. (2) treated with furosemide, amiloride, and nifedipine. (3) hypertension, chronic liver disease, chronic heart disease, and chronic kidney disease resulting from causes except alport syndrome. (4) history of hyperlactatemia. (5) allergy to metformin. (6) kidney transplant. (7) poor compliance. (8) type 1 diabetes.