Kornimate/medical-research-clean huggingface dataset:
a pharmacokinetic study of mk-3102 in participants with impaired hepatic function (mk-3102-031)

Conditions: Diabetes Mellitus, Type 2

Summary: this study will investigate and compare the pharmacokinetics of a single 25-mg dose of mk-3102 in participants with moderate hepatic impairment and matched healthy participants. the primary hypothesis is that in participants with moderately impaired hepatic function, the area under the concentration-time curve from time zero to infinity (auc0-∞) is similar to that observed in healthy matched control participants following a single 25 mg oral dose of mk-3102. specifically, the true ratio (moderately impaired hepatic function patients/healthy matched control subjects) of geometric means for auc0-∞ is no greater than 2.


Eligibility criteria:
inclusion criteria: impaired hepatic function participants: * a diagnosis of: 1. chronic (\> 6 months) hepatic insufficiency 2. stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology * score on the child-pugh scale of 7 to 9 (moderate hepatic insufficiency) * estimated creatinine clearance (clcr) \> 60 ml/min or glomerular filtration rate (egfr) ≥ 60 ml/min/1.73 m\^2 both impaired hepatic function and healthy participants: * in general good health * continuous non-smokers or moderate smokers for at least 3 months prior to study start * body mass index ≤39 kg/m\^2 * females of reproductive potential must have a negative pregnancy test and agree to use acceptable birth control method(s) or remain sexually inactive throughout study * non-vasectomized male patients must agree to use acceptable birth control method(s) or abstain from sexual intercourse during the trial and for 3 months after the study exclusion criteria: healthy participants: * history or presence of alcoholism within the past 2 years * presence of hepatitis b virus (hbv) or hepatitis virus c (hvc) both impaired hepatic function and healthy participants: * history or presence of drug abuse within the past 2 years * history or presence of human immunodeficiency virus (hiv) * history or presence of significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (other than hepatic impairment), endocrine, immunologic, dermatologic, or neurological disease * use of any medication or substance (including prescription or over the counter, health supplements, natural or herbal supplements) which cannot be discontinued at least 14 days prior to the study start and throughout the study * has been on a special diet within 28 days prior to the study start * blood donation within 56 days or plasma donation within 7 days prior to study start * participation in another clinical trial within 28 days of study start * women who are pregnant or nursing

Keywords: diabetes mellitus diabetes mellitus, type 2 glucose metabolism disorders metabolic diseases endocrine system diseases
cross-sectional analysis of non-technical attributes and surgical experience in surgical staff, trainees and applicants.

Conditions: Healthy Volunteers

Summary: this study consists of an analysis of the communication styles and attitudes towards risk and uncertainty (i.e. non-technical attributes) in a surgical population with varying clinical experience. the study aims to investigate the differences and specific patterns in non-technical attributes that may be discerned in these groups and how these non technical attributes develop throughout surgical training.

this study evaluated the communication styles and attitudes towards risk and uncertainty in a population of surgical candidates (pre- and postgraduates), surgical trainees and surgical staff members, from the specialties of general surgery, orthopedics, urology and plastic surgery. after signing informed consent, participants complete an on-line questionnaire, which contains a set of validated tools. initially, a cross-sectional analysis of the non-technical attributes will be conducted, to identify any patters, similarities or differences between participant groups. the study hypothesis is that significant differences can be observed in participant attributes, which relate to their clinical experience. additionally, surgical candidates who agree to participate in this study and are accepted for a surgical training in either general surgery, orthopaedics, urology or plastic surgery, will be invited to repeat the questionnaire at a 2-year interval, to investigate the evolution of their non-technical attributes throughout their training and to identify general patterns.

Eligibility criteria:
inclusion criteria: * participant is part of any of the following groups: * applicant for surgical training in general surgery, orthopedics, urology or plastic surgery. * trainee in general surgery, orthopedics, urology, plastic surgery. * staff in general surgery, orthopedics, urology, plastic surgery. * participant is active at ghent university hospital or an affiliated training hospital. no exclusion criteria apply to this study.

Keywords: non-technical attributes surgical training communication style risk aversion reaction to uncertainty self-assessment
a trial to compare the ovarian response of rekovelle and gonal-f in conventional dosing in women undergoing controlled ovarian stimulation

Conditions: Infertility

Summary: hormone preparations like rekovelle and gonal-f are used to make the body produce multiple egg sacs, allowing more eggs to be collected from women undergoing infertility treatment. the main purpose of this trial is to see how many eggs are produced with a starting dose of 15 µg rekovelle compared to a starting dose of 225 iu gonal-f. this research is intended to provide more knowledge about rekovelle, including the doses given in the trial.


Eligibility criteria:
inclusion criteria: * infertile women aged 18-40 years * diagnosed with tubal infertility, unexplained infertility, mild endometriosis (stage i/ii) or partners with decreased sperm quality * medically eligible for in vitro fertilization (ivf) and/or intracytoplasmic sperm injection (icsi) * infertility for at least one year for participants ≤ 37 years or for at least 6 months for participants ≥ 38 years * regular menstrual cycles of 21-35 days. exclusion criteria: * known condition of not functioning ovaries * known advanced endometriosis (stage iii/iv) * considered unsuitable for controlled ovarian stimulation with a dosing regimen corresponding to approximately 225 iu/day gonadotropin, as judged by the investigator * history of previous episode of ohss or exuberant ovarian response to gonadotropins, and polycystic ovarian syndrome * any known hormonal or metabolic abnormalities which can compromise participation in the trial * known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
confirmatory phase ii study of blinatumomab (mt103) in patients with minimal residual disease of b-precursor acute lymphoblastic leukemia (all)

Conditions: B-cell Acute Lymphoblastic Leukemia

Summary: the purpose of this study is to confirm whether the bispecific t cell engager blinatumomab (mt103) is effective, safe and tolerable in the treatment of all patients with minimal residual disease.

the detection of minimal residual disease (mrd) after induction therapy and/or consolidation therapy is an independent prognostic factor for poor outcome of adult all. no standard treatments are available for patients with mrd-positive b-precursor all. blinatumomab (mt103) is a bispecific single-chain antibody construct designed to link b cells and t cells resulting in t-cell activation and a cytotoxic t-cell response against cluster of differentiation (cd)19 expressing cells. the purpose of this study is to confirm whether the bispecific t-cell engager blinatumomab (mt103) is effective, safe and tolerable in the treatment of all patients with minimal residual disease. participants will receive up to four 4-week cycles of intravenous blinatumomab treatment followed by an infusion-free period of 14 days. a safety follow-up will be performed 30 days after the end of the last infusion and efficacy follow-ups will occur until 24 months after treatment start. participants will be followed for up to 5 years after the start of treatment for survival.

Eligibility criteria:
inclusion criteria: * patients with b-precursor all in complete hematological remission after at least 3 intense chemotherapy blocks * presence of minimal residual disease at a level of ≥ 10\^-3 * availability of bone marrow specimen from primary diagnosis for clone-specific mrd assessment * negative human immunodeficiency virus (hiv) test, negative hepatitis b (hbsag) test and hepatitis c virus (anti-hcv) test * negative pregnancy test in women of childbearing potential * eastern cooperative oncology group (ecog) performance status 0 or 1 exclusion criteria: * presence of circulating blasts or current extra-medullary involvement by all * history of relevant central nervous system (cns) pathology or current cns pathology * prior allogeneic hematopoietic stem cell transplant (hsct) * eligibility for treatment with tyrosine-kinase inhibitors (tki) * systemic cancer chemotherapy within 2 weeks prior to study treatment * therapy with monoclonal antibodies (rituximab, alemtuzumab) within 4 weeks prior to study treatment * previous treatment with blinatumomab

Keywords: blinatumomab mrd b-all minimal residual disease adult all leukemia all lymphatic diseases lymphoproliferative disorders bispecific antibody anti-cd19 immunotherapeutic treatment
cardiovascular fitness of patients with multiple sclerosis, effect of exercise on fatigue and depression

Conditions: Multiple Sclerosis

Summary: this study is focused on patients with multiple sclerosis (ms), their cardiovascular fitness, and the effect of combined controlled training on the perception of fatigue, the development of depression, and quality of life in the first year after diagnosis.

the main goal is to find out if fatigue, depression, and quality of life depend on the type of training as well as controlled management of newly diagnosed patients. fatigue is one of the frequent disabling symptoms and the most difficult to influence pharmacologically. it could lead to inactivity and the progression of deconditioning. we know from systematic reviews that aerobic activity leads to improvement in fatigue, however, there are also opinions about exercise intolerance due to disruption of cardiac autonomy control. the investigators will try to determine whether early rehabilitation intervention leads to support and motivation of patients with an incurable chronic neurodegenerative disease to improve the patient condition and contentment. the researchers will focus on effective training by comparing the study group with a control group of patients undergoing conventional rehabilitation versus a protocol-defined controlled combined (aerobic-resistant) exercise program - based on the results of spiroergometry. both groups will be treated at ambulatory sections by protocol-defined rehabilitation for a 1-hour duration, twice a week for one month, and once a week for the next month (12 therapies in total). the control group will be educated in exercises according to kinesiological analysis to do regularly at home. finally, the researchers will see if early intervention leads to a change in the active approach of probands.

Eligibility criteria:
inclusion criteria: * age 20 - 45 years * newly diagnosed patients with multiple sclerosis * relapsing-remitting ms (rrms) or clinically isolated syndrome (cis) * edss 0-6 * signed informed consent exclusion criteria: * progressive forms of ms (prms or spms), malignant ms * non-cooperation, disagreement with the study * contraindication to spiroergometry

Keywords: multiple sclerosis controlled combined exercise cardiovascular fitness fatigue depression
sickle cell uric acid (scua) - cohort repository

Conditions: Chronic Kidney Diseases; Sickle Cell Disease

Summary: the purpose of this research is to study the causes of sickle cell kidney disease, as well as to collect and store samples and information about people with sickle cell disease.

sickle cell disease causes kidney injury over time, but it is not clear why some individuals have very significant chronic kidney disease and why some do not. the purpose of this research is to study whether having high levels of 'uric acid,' which is a naturally occurring molecule in the body that may increase kidney injury and systemic inflammation, accelerates the progression of chronic kidney disease over time. researchers will measure the number of participants that have high uric acid levels at the beginning of the study, as well as the number of participants that develop new high levels throughout the study. the study will also try to determine what causes the high uric acid levels in some patients but not others. the results of this study could help understand kidney injury and uric acid in sickle cell disease better.

Eligibility criteria:
inclusion criteria: * age 5-29 years * sickle cell disease as diagnosed by hemoglobin electrophoresis, or by newborn screen per standard of care * currently receiving comprehensive sickle cell care at the children's hospital of richmond at vcu or in the adult internal medicine sickle cell care clinic at vcu. exclusion criteria: * those who have received organ, stem cell, or bone marrow transplantation. - those who require chronic dialysis

Keywords: uric acid
efficacy and safety of nerivio for the acute treatment of menstrual migraine

Conditions: Menstrual Migraine

Summary: post-marketing, retrospective, observational survey study. users (menstruating women only) of nerivio who have used nerivio at least 4 times between october 2019 and december 2020 will be contacted by email and/or through an app notification and will be asked to complete a 5-minute online anonymous survey assessing satisfaction, effectiveness, and safety. eligible users will sign an informed consent form (the consent language will appear as the first page of the survey, and participants will click either "agree" or "disagree" to the consent statement; those who click "agree" will proceed to the survey, those who click "disagree" will be brought to an exit page) and complete a survey asking about their satisfaction with nerivio and the effectiveness and safety of the device for acute treatment of menstrual migraine. during the survey, participants will be screened to verify that they have menstrual migraine (self-reported) and have used nerivio to treat menstrual migraines.

this study aims to evaluate the safety and efficacy of nerivio for the acute treatment of menstrual migraine (pure menstrual migraine or menstrually-related migraine). up to 500 us-based adults aged 18-55 years old who have been prescribed the nerivio device and have used it at least 4 times between october 2019 and december 2020. informed consent must be obtained from the participant before any protocol-related activities are performed. the consent language will appear as the first page of the survey, and participants will click either "agree" or "disagree" to the consent statement; those who click "agree" will proceed to the survey, those who click "disagree" will be brought to an exit page. users of nerivio whose details are in the sponsor's database will be contacted by email (provided by the patient during the sign-up process in the nerivio app required to use the device) and/or through an app notification and will be asked to complete a 5-minute online survey assessing satisfaction, effectiveness, and safety. participants will sign an informed consent form which will appear as the first page of the survey using open-ended questions, multiple choice questions and likert scales. participants will be directed to provide honest opinions regarding the device use for menstrual migraine. no additional information will be collected, and no medical records will be used in this investigation.

Eligibility criteria:
inclusion criteria: 1. women aged 18-55 years 2. participants have used nerivio at least 4 times 3. participants experience menstrual migraines (pure menstrual migraine or menstrually-related migraine; self-reported) 4. participants have used nerivio to treat menstrual migraine exclusion criteria: 1. non-menstruating women
study of vir-2218 in healthy subjects and patients with chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: this is a phase 1/2 study in which healthy adult subjects and subjects with chronic hepatitis b virus (hbv) infection will receive vir-2218 or placebo and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity (only in subjects with chronic hbv). in the single ascending dose (sad) part, part a, healthy adult subjects will receive one dose of vir-2218 or placebo, administered subcutaneously (sc). in the multiple ascending dose (mad) parts, part b \& part c, subjects with chronic hbv infection will receive two doses of vir-2218 or placebo every 4 weeks administered sc.


Eligibility criteria:
part a sad: inclusion criteria: * male or female age 18 - 55 * bmi 18 - 32 kg/m\^2 exclusion criteria: * any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation * history or evidence of drug or alcohol abuse * history of intolerance to sc injection parts b/c mad: inclusion criteria: * male or female age 18 - 65 * bmi 18 - 32 kg/m\^2 * chronic hbv infection for \>/= 6 months exclusion criteria: * any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation * significant fibrosis or cirrhosis * history or evidence of drug or alcohol abuse * history of intolerance to sc injection * history of chronic liver disease from any cause other than chronic hbv infection * history of hepatic decompensation

Keywords: hepatitis b virus chronic hepatitis b hbv hepatitis
a study of ustekinumab in chinese participants with active systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: the purpose of this study is to evaluate the efficacy of ustekinumab in chinese participants with active systemic lupus erythematosus (sle) who have not adequately responded to one or more standard-of-care treatments.


Eligibility criteria:
inclusion criteria: * had a documented medical history (that is, met at least 1 of the two criteria below) that participant met the systemic lupus international collaborating clinics (slicc) classification criteria for systemic lupus erythematosus (sle) at least 3 months prior to first dose of study agent: 1. met a total of at least 4 slicc criteria, including at least 1 clinical and at least 1 immunologic; 2. has a diagnosis of lupus nephritis, confirmed by renal biopsy and at least 1 of the following autoantibodies: antinuclear antibodies (ana) or anti-double-stranded deoxyribonucleic acid (anti-dsdna) * have a positive test in the medical history and confirmed at screening for at least 1 of the following autoantibodies: antinuclear antibodies, anti-double-stranded deoxyribonucleic acid, and/or anti-smith * have at least 1 british isles lupus assessment group (bilag) a and/or 2 bilag b scores observed during screening * have a cutaneous lupus erythematosus disease area and severity index (clasi) activity score at least 4 (excluding diffuse non-inflammatory alopecia) or at least 4 joints with pain and signs of inflammation at screening, week 0, or both * have a systemic lupus erythematosus disease activity index 2000 (sledai-2k) score greater than or equal to \[\>=\] 6 at screening. must also have sledai-2k \>= 4 for clinical features (excluding headache and laboratory abnormalities) at week 0 exclusion criteria: * has any unstable or progressive sle manifestation (example: central nervous system lupus, systemic vasculitis, end-stage renal disease, severe or rapidly progressive glomerulonephritis, pulmonary hemorrhage, myocarditis) that may warrant escalation in therapy beyond permitted background medications. participants requiring renal hemodialysis or peritoneal dialysis are also excluded * has other inflammatory diseases that might confound the evaluations of efficacy (including but not limited to rheumatoid arthritis, psoriasis, psoriatic arthritis, crohn's disease) * has urinary protein level of greater than (\>) 4 gram per day (g/day) or protein/creatinine ratio estimating \>4g/day equivalent proteinuria * has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients * has a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location, clinically significant splenomegaly, or history of monoclonal gammopathy of undetermined significance
a clinical trial of efficacy and safety of the holistic treatment of young high-risk multiple myeloma patients

Conditions: Multiple Myeloma; Plasma Cell Leukemia; Extramedullary Plasmacytoma; Loss of Chromosome 17p; t(14;16); t(4;14); T(14;20); 1Q21 Amplification; Complex Karyotype

Summary: the clinical trial was conducted in a cohort of young, high-risk myeloma patients who were designed to receive a combination of high-dose chemotherapy with allogeneic or autologous hematopoietic stem cell transplantation. the objective was to assess the progression free survival (pfs), overall survival (os),and overall response rate (orr) of the overall treatment.

50 cases of hr-ndmm patients were divided into two groups nonrandomizedly. te group received hematopoietic stem cell transplantation after induction therapy. allo-sct for the young patients with suitable donors, asct for the others. tne group received consolidation therapy after induction therapy. all patients received pi-based maintenance therapy.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of high-risk multiple myeloma in addition, patients must meet at least one of the following criteria i-ix (i-viii at time of diagnosis or pre-autograft): i.complex karyotype ii.fluorescent in situ hybridization (fish) translocation 4:14 or 14:16, iii.fish translocation 1q21, iv.fish deletion 17p, v.r-iss iii stage, vi.two or more high-risk cytogenetic abnormalities exist vii.plasma cell leukemia viii.extramedullary plasmacytoma ix.recurrent or non-responsive (less than partial remission \[pr\]) mm after at least 4 cycles of pi/imids-based chemotherapy 2. candidate for high-dose chemotherapy with stem cell transplantation 3. ecog performance status score of 0,1,or2 - exclusion criteria: 1. the current diagnosis of smoldering multiple myeloma, monoclonal gammopathy of undetermined significance of disease, waldenstr o m macroglobulinemia. 2. during the first 5 years of the study, there were no other malignancies, including basal cell carcinoma or in situ cervical cancer. 3. according to the national cancer institute general toxicity criteria (nci ctc), subjects had peripheral neuropathy of grade 2 or above: 4. were enrolled within 6 months before had a myocardial infarction, or new york heart association (nyha) iii or iv heart failure ,uncontrolled angina, uncontrolled severe ventricular arrhythmias or ecg evidence of acute ischemia or conduction system abnormalities and activity the clinical significance of pericardial disease, or cardiac amyloidosis -