Kornimate/medical-research-clean huggingface dataset:
acp-196 versus placebo in subjects with rheumatoid arthritis on background methotrexate

Conditions: Rheumatoid Arthritis

Summary: this study is evaluating the safety, pharmacokinetics (pk), pharmacodynamics (pd) and efficacy of acp-196 in subjects with rheumatoid arthritis on background methotrexate.

a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. the on-treatment period is 4 weeks with weekly visits to the clinic, followed by a 4-week safety follow-up period after the last dose of acp-196/placebo. the study was to evaluate the safety, pk, pd, and efficacy of acp-196 in subjects with rheumatoid arthritis on background methotrexate

Eligibility criteria:
main inclusion criteria: * diagnosis of ra according to the 2010 acr/eular classification criteria . * must be on a stable mtx dose (7.5 to 25 mg/week) * subjects must be able to read and understand the consent form, complete the study-related procedures, and communicate with the study staff. * are willing and able to adhere to the study visit schedule, and understand and comply with other protocol requirements. main exclusion criteria: * prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 5 years. * a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acp-196, or put the study outcomes at undue risk. * subjects who have taken any investigational drug within the previous 30 days before randomization. * use of all other synthetic disease-modifying antirheumatic drugs (dmards) such as but not limited to leflunomide, azathioprine, cyclosporine, penicillamine or gold salts within 8 weeks of randomization. * use of etanercept, anakinra, tofacitinib within 4 weeks of randomization. * use of abatacept, humira, infliximab, or tocilizumab within 8 weeks of randomization.

Keywords: acalabrutinib
temporal relationship in recovery of muscular pain and functional variables in an experimental muscular pain model in hamstrings

Conditions: Pain, Muscle

Summary: basal measurements are taken in relation to the study variables. immediately subjects perform eccentric exercise on right hamstrings to develop delayed onset muscle soreness (doms). measurements of the study variables are taken in the same conditions 48, 96 and 168 hours after the exercise to study the evolution of the variables while recovering from doms.

basal measurements are taken in relation to the study variables. the variables are: * pressure pain thresholds * electromyography values * static and dynamic plantar pressure measurement * active knee extensibility * maximal strength of knee flexors * thermography * scales of pain perception immediately subjects perform eccentric exercise on right hamstrings to develop doms (delay onset muscle soreness). measurements of the study variables are taken in the same conditions 48, 96 and 168 hours after the exercise to study the evolution of the variables while recovering from doms.

Eligibility criteria:
inclusion criteria: * not sedentary subject (ipaq scale \> 600 met) * healthy subjects, without pain nor injury at the moment exclusion criteria: * subjects with acute or chronic pain on every spot of pelvis or lower limbs at the momento or for the last 3 months; * subjects with history of severe injury in the hamstrings muscles; * presence of serious illness; * presence of pathologies in relation to chronic pain (as fibromyalgia, migraine disorders, non specific and chronic lumbar pain); * not commitment for continuity in the study program;

Keywords: doms healthy subjects pressure pain thresholds active knee extension test maximal strength electromyography plantar pressure measurement gait analysis
pathophysiology of gas exchange and time course changes in spontaneously breathing patients with acute respiratory failure due to covid-19. a multicenter prospective study.

Conditions: Respiratory Insufficiency

Summary: the pathophysiology of sars-cov-2 related respiratory disease is still poorly understood, especially in its most severe form called acute respiratory distress syndrome (ards). in this case, very few studies have investigated changes in gas exchange during covid-19 progression in spontaneously breathing patients. the investigators purpose in this study to explore the pathophysiology of gas exchange and time course changes in spontaneously breathing patients with acute respiratory failure due to covid-19. moreover, our aim is to identify early markers associated with worsening respiratory failure and requiring endotracheal intubation.


Eligibility criteria:
inclusion criteria : * patients with a covid-19 confirmed infection. * admission in intensive care unit for an acute respiratory failure requiring oxygen flow above 6l/min by facial mask. * presence of an arterial catheter for blood sampling. exclusion criteria : * patients on mechanical ventilation on admission to the icu. * patients requiring immediate intubation on admission. * patients admitted to the icu for more than 48 hours at the time of inclusion. * pulmonary embolism diagnosed before admission to the icu. * minor patients * pregnant women * patients under curatorship or guardianship * persons deprived of liberty by a judicial or administrative decision

Keywords: gas exchange covid-19 acute respiratory distress syndrome spontaneous breathing respiratory failure
fetal brain care: therapies for brain neurodevelopment in fetal growth restriction

Conditions: Fetal Growth Retardation; Intrauterine Growth Restriction

Summary: singleton pregnancies being diagnosed of fetal growth restriction from 24 to 32.6 weeks of gestation will be randomized to two equally sized groups: maternal oral supplementation with lactoferrin and dha (docosahexaenoic acid) or placebo.

randomized controlled trial among pregnant women that have been diagnosed of fetal growth restriction. these women will be randomized in order to evaluate the impact of maternal supplementation with lactoferrin and dha on the neurodevelopment outcome of their babies. main hypothesis: a prenatal intervention based on maternal supplementation with lactoferrin and dha improves neurodevelopment in fetal growth restriction. secondary hypothesis are that a prenatal intervention based on maternal supplementation with lactoferrin and dha in fetal growth restriction improves fetal growth and improves perinatal morbidity and mortality.

Eligibility criteria:
inclusion criteria: * singleton pregnancies * non-malformed fetus * pregnancies with fetal growth restriction * 24-32.6 weeks of gestation exclusion criteria: * chromosomal or structural abnormalities diagnosed during pregnancy or in the neonatal period * critical doppler study suggesting the need for delivery within the next 14 days at the time of diagnosis: reverse end-diastolic velocity in the umbilical artery or ductus venosus pulsatility \>95th centile * maternal mental or psychiatric disorders * maternal allergy to cow's milk protein

Keywords: fetal growth retardation fetal growth restriction intrauterine growth restriction neurodevelopment lactoferrin dha
greek nis spiolto ellacto

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: open-label observational study: including copd patients receiving treatment with spiolto® respimat® for approximately 6 weeks, which is the average time between two medical consultations


Eligibility criteria:
inclusion criteria: * therapeutic indication before entering the enrollment face is patients diagnosed with copd requiring a combination therapy of two long-acting bronchodilators (lama + laba) according to approved smpc and guidelines, copd gold 2017 groups b to d * female and male patients ≥40 years of age * treatment with spiolto ® respimat® acc. to smpc and at the discretion of the physician * written informed consent prior to participation exclusion criteria: * patients with contraindications according to spiolto® respimat® smpc * patients who have been treated with a laba/lama combination (free and fixed dose) in the previous 6 weeks or patients already on a combination of lama and laba therapy; either as a fixed combination product or as separate components note: patients previously treated with laba or lama (with or without ics) are eligible to be included in the study * patients continuing laba-ics treatment should not be additionally treated with spiolto® respimat® in order to avoid a double dosing of long-acting beta-agonists * patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks * pregnancy and lactation * patients currently listed for lung transplantation * current participation in any clinical trial or any other non-interventional study of a drug or device
development of clinical indicators from the swiss rai-hc

Conditions: Frail Elderly Syndrome

Summary: the project aims at deriving frailty (fi) and complexity (ci) indices from data collected with the resident instrument assessment - home care adapted for switzerland (rai-hc). data were collected in 2015 by trained nurses in clinical routine with the primary purposes of health state assessment and individual home care planning. the study consists in a retrospective secondary analysis of health data from the minimal data set (mds), used to derive frailty and complexity indices according to published definitions and guidelines for index derivation. the analysis further aims at estimating the predictive power of these indices on undesirable health outcomes (falls, hospitalizations and deaths). the goal is to provide home care institutions and nurses valid algorithms to compute useful clinical indicators without additional assessment that the one routinely done with the rai-hc.


Eligibility criteria:
inclusion criteria: * men and women aged 18 or older who were assessed in 2015 with the swiss rai-hc in clinical routine for care planning by the geneva institution for home care and assistance (imad) in geneva, switzerland exclusion criteria: * men and women aged 17 or younger and/or who did not receive a full rai-hc assessment in 2015

Keywords: home care services aging frailty complexity nursing
evaluation of anti-mullerian hormone(amh) levels as a predictive factor of response to weight loss treatment in obese infertile women with poly cystic ovary(pcos)

Conditions: Infertility

Summary: this study is a prospective before \& after clinical trial to compare the basal and 3 months after diet anti-mullerian hormone levels between responders and non-responders to weight loss diet in obese infertile women with pcos population

the study population comprised of all obese infertile pcos patients aged 20-40 years which underwent 3 months weight loss diet in royan institute, tehran iran. the study is conducted over 12 wk energy restriction. all subjects have the same dietary protocol. at baseline, week 12 the levels of amh,follicular stimulating hormone (fsh), lutienizing hormone(lh),prolactin (prl), androgens, sex hormone-binding globulin (shbg), glucose, and insulin were measured and free androgen index (fai) and insulin resistance (ir) indices is calculated. the laboratory tests are determined by radioimmunoassay in the laboratory of endocrinology of royan institute. amh is measured in duplicate using an ultrasensitive elisa kit (amh-eliza kit; beckman coulter, marseilles, france) according to manufacturer instructions. all measurements are performed using a single kit and at the same time in the laboratory of clinical immunology of royan institute. data collection will be performed by using questionnaire to be filled as per the available records and laboratory results. data analysis will be done through descriptive and perceptive statistical methods.

Eligibility criteria:
inclusion criteria: - 1- diagnosis of pcos, according to the rotterdam consensus workshop group, by 2 of the following 3 criteria: menstrual irregularity (cycle length\ 31 d or variation between consecutive cycles of \>3 d); clinical (hirsutism assessed by a ferriman-gallwey score \> 8) or biochemical \[free androgen index (fai) \> 5.4 or testosterone_1.4 nmol/l\] hyperandrogenism; or positive ultrasound presentation of polycystic ovaries by transvaginal scan. 2- age between 18 -40 exclusion criteria: - 1. body mass index (bmi; in kg/m2) \< 30, 2. type 2 diabetes mellitus and related endocrinopathic disorders \[identified by assessment of thyroid-stimulating hormone (tsh), prolactin, and 17_hydroxyprogesterone\]. 3. regular exercise activities during the study. 4. cases of alcoholism and smoking. 5. the use of endocrine hormonal treatment or insulin-sensitizing agents is not permitted during either phase of the study, and the use of oral contraceptives is not permitted during of the study. subjects are required to cease taking oral contraceptives 4 wk and hormonal treatment or insulin-sensitizing agents 2 wk before commencement of the short-term study phase.

Keywords: anti-mullerian hormone (amh) level, poly cystic ovarian syndrome obese infertility weight loss diet
sodiumhexametaphosphate versus mta as pulp capping material for immature permanent teeth

Conditions: Pulp Disease, Dental

Summary: sodiumhexametaphosphate will be used as capping material for dental pulp of immature permanent teeth


Eligibility criteria:
inclusion criteria: * healthy children * cooperative children * deep carious lesion * traumatic pulp exposure * immature permanent teeth exclusion criteria: * uncooperative children * children with systemic disorders * non vital immature permanent teeth
one year skeletal and dental arch changes following rapid maxillary expansion treatment in children

Conditions: Cross-bite

Summary: many author have exposed the rapid and slow expansion, the diversity of activation and containment protocols and the follow-up time, justify the need for more studies to evaluate the effects to the erm for the long-term.


Eligibility criteria:
inclusion criteria: * cross-bite with maxillary atresia exclusion criteria: * patients had undergone orthodontic treatment or had a syndrome

Keywords: rapid maxillary expansion cross bite haas appliance lateral cephalograms
mindfulness training for medical personnel

Conditions: Burnout, Professional; Stress

Summary: in this project, the investigators propose to evaluate the impact of a mindfulness-based intervention (mbi) program on the well-being of university of miami (um) clinicians and faculty/staff. if successfully implemented and proven to be effective, this training program may be disseminated to other interested medical personnel.


Eligibility criteria:
inclusion criteria: * medical faculty, fellows, residents, and other allied healthcare providers at um miller school of medicine and jackson will be eligible for participation in the study. exclusion criteria: * those not falling into inclusion criteria.
effectiveness and safety study for rwj-333369 as adjunctive therapy in korean and japanese patients with partial onset seizures

Conditions: Seizures

Summary: the purpose of the study is to evaluate the effectiveness and safety of adjunctive rwj-333369 at a dose of 200 or 400 mg/day in comparison with placebo in korean and japanese partial epilepsy patients who have poor seizure control with one or two antiepileptics (aeds).

despite the introduction of new antiepileptic drugs into overseas clinical settings after 1990's, there still exist those patients who cannot control seizures, and thus the advent of newer antiepileptic drugs is being desired. this is a multicenter, placebo-controlled, double-blind (neither the study physician nor the patient knows the name of the study assigned medication), randomized (study drug assigned by chance), parallel-group study. it consists of three periods: pretreatment phase (screening and baseline periods), double-blind treatment phase, and posttreatment phase (transitional period or dose-tapering/withdrawal period). patients who complete double-blind treatment phase will be qualified to participate in the long-term extension study (study 333369-kj-03) following the present study. the primary hypothesis is that at 400mg/day of rwj-333369 is effective in the adjunctive treatment of patients with partial onset epilepsy, as measured by the percent reduction from baseline in monthly seizure frequency of partial onset seizures. safety is evaluated based on the following variables; adverse event, lab test, electrocardiogram, vital signs, pregnancy test, physician withdrawal checklist. patients will receive the assigned dose (placebo, 200 mg/day, or 400 mg/day) twice daily orally for 12 weeks (85 days)

Eligibility criteria:
inclusion criteria: * body weight of 40 kg or more * established diagnosis of partial epilepsy for at least 1 year * current treatment with at least one and no more than two antiepileptics (aeds) * at least 6 episodes of simple partial motor seizures, complex partial seizures, or secondarily generalized seizures for 2 months (56 days) during the baseline period (no seizure free interval for more than 3 weeks) exclusion criteria: * diagnosis of status epilepticus or epilepsia partialis continua within 6 months * patients with generalized epileptic syndrome * current or previous history of non-epileptic seizures, including psychogenic seizures * current or previous history of any serious or medically relevant systemic disease, including clinically apparent hepatic disease, renal failure, malignant neoplasm, insulin-requiring diabetes mellitus, or any disorder * patients with clinical evidence of significant cardiac disease * current or past (within 1 year) major significant psychotic disorder * have an alt (gpt) greater than 1.5 times the upper reference limit or total bilirubin above the upper reference limit at screening laboratory tests

Keywords: partial onset seizure adjunctive therapy
a phase i study to investigate the effect of renal impairment on the pharmacokinetics, safety, and tolerability of azd5004

Conditions: Renal Impairment

Summary: this is a phase i, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the pk, safety, and tolerability of azd5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function.

this is a phase i, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the pk, safety, and tolerability of azd5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function. participants will be assigned to the following groups based on egfr determined at screening by a local laboratory using serum creatinine: group 1: participants with severe renal impairment (egfr \< 30 ml/min), not on dialysis. group 2: participants with normal renal function (egfr of ≥ 90 ml/min) matched by sex, age, and body weight on a group level to the impaired participants. group 3 (optional): participants with moderate renal impairment (egfr ≥ 30 to \< 60 ml/min).

Eligibility criteria:
inclusion criteria: * adults 18-80 years of age * weight \>50kg and bmi between 18-40 kg/m2 for participants with normal renal function: -participant must be medically healthy with no significant findings on medical evaluation and an egfr ≥90 ml/min at screening. for participants with renal impairment: group 1 (severe) must have an egfr \<30 ml/min and group 3 (moderate) must have an egfr 30 to \<60 ml/min based on ckd-epi calculations for at least 6 months prior to enrollment. exclusion criteria: * poorly controlled diabetes mellitus (a1c \>10% at screening or recent history of diabetic ketoacidosis or symptomatic hypoglycemia). * unwillingness to use adequate contraception * uncontrolled hypertension or hypotension. * positive screening for hiv, hepatitis b, or hepatitis c * presence of unstable systemic disease or psychologic conditions. abnormal laboratory values to include but not limited to liver function tests (thresholds differ for renal impairment and health controls) * any change in baseline medication within 2 weeks of planned study initiation.

Keywords: renal impairment healthy participants azd5004 pharmacokinetics safety
effects of gender-affirming hormone therapy on transgender people

Conditions: Gender Dysphoria

Summary: this prospective cohort study aims to assess the impact of gender-affirming hormone therapy (gaht) on transgender individuals' physical, psychological, social, and quality of life aspects. based on gender minority stress theory, the research recruits 150 individuals each of those starting gaht and those not yet undergoing it. data collection involves questionnaires and physiological measurements. statistical analyses will explore correlations and group differences. findings can guide transgender individuals considering hormone therapy and enhance care guidelines to improve their overall well-being.

the willingness and proportion of transgender persons diagnosed with gender dysphoria to receive gender-affirming hormone therapy (gaht) is relatively high, so as to conform to their internal gender identity. however, there are limited studies on the prospectively observation of the influences and effectiveness of gaht on physical, psychological, social and quality of life of transgender people. this study is a cross-sectional research prospective cohort study design, and the research framework is developed based on gender minority stress theory. it is expected to recruit a group of 150 transgender people, including trans male, trans female, and non-binary person, who have just started using gaht, and a group of 150 who has not yet received gaht. the data collection time is about 40-50 minutes each time. the questionnaires will be applied to collect basic demographic information, basic hormonal information, body changes, body image, sexual wellbeing, sexual risk, depression, social support, and quality of life. the instruments will be applied to measure participants' physiological parameters, including weight, body fat, and muscle mass, hand grip strength, and blood pressure. in the statistical part, correlation and regression will be used to analyze the degree of correlation between variables, and multivariate analysis of covariance will be used to detect whether there was a significant difference between the variables of the two groups. a well understanding of the experiences and reactions of transgender people receiving hormone therapy can provide a reference for transgender people before deciding to accept hormone therapy, and can be used as an important reference for formulating care guidelines for gender-affirming hormone therapy to improve the care quality for the gender minority population.

Eligibility criteria:
inclusion criteria: * transgender exclusion criteria: -

Keywords: depression gender-affirming hormone therapy
our care wishes - dementia

Conditions: Dementia; Alzheimer Disease; Memory Impairment

Summary: this our care wishes- dementia pilot study is adapting an existing successful online advance care planning platform to the specific needs of persons living with dementia and shared decision-makers (sdms) and testing the usability and acceptability among nursing home residents and sdms.


Eligibility criteria:
inclusion criteria: * eligible plwd will be receiving short-or long-term care at a participating nh, have documented moderate to severe cognitive impairment as measured by the cognitive function scale included in the minimum data set 3.0, 65 and have an identified sdm. exclusion criteria: * participants are not eligible discharged from participating nhs, or do not have access to a telephone or video chat.

Keywords: advance care planning shared decision-making web-based platform memory care nursing homes