Kornimate/medical-research-clean huggingface dataset:
biomarkers to predict acute respiratory distress syndrome(ards) in patients with sepsis

Conditions: Sepsis

Summary: sepsis-induced acute respiratory distress syndrome (ards) is a life-threatening acute inflammatory lung injury, associated with increased pulmonary microvascular permeability, increased lung weight, and loss of aerated lung tissue.despite advances in critical care, no established and targeted treatment for ards, contributing to a persistently high mortality rate of 34% to 45%. therefore, exploring novel therapeutic targets for septic ards is of paramount importance.acetaldehyde dehydrogenase 2 (aldh2) is a mitochondrial enzyme that serves as the primary toxic aldehyde scavenger and is expressed in various cells, including neutrophils. the aldh2 rs671 single nucleotide polymorphism, leading to an approximate 90% decrease in aldh2 enzymatic activity, is implicated in occurrence of macrovascular conditions, such as coronary artery disease, pulmonary arterial hypertension, and aortic aneurysm or dissection.an array of studies has delved into role of aldh2 in regulating cellular processes, including inflammation, autophagy, apoptosis, necrosis,efferocytosis and pyroptosis.but whether it associated with the incidence of septic-ards remains unknown.the aim of this study was to determine whether the aldh2 rs671 single nucleotide polymorphism was associated with the incidence of septic-ards.


Eligibility criteria:
inclusion criteria: patients admitted to the icu who were aged 18 to 85 years with a diagnosis of sepsis.sepsis was assessed according to the third international consensus definition as life-threatening organ dysfunction caused by a dysregulated host response to infection; organ dysfunction was defined as an acute change in total sequential organ failure assessment (sofa) score of ≥2 points consequent to the infection. exclusion criteria: 1. interstitial lung disease, chronic obstructive pulmonary disease or congestive heart failure; 2. nerve injury or disease with likely prolonged ventilation； 3. the use of long-term oxygen therapy or noninvasive ventilation at home; 4. pregnancy or breastfeeding.

Keywords: sepsis ards
bioequivalence study of atazanavir 300 mg capsule

Conditions: HIV Infections

Summary: the purpose of this clinical research study is to assess the bioequivalence of atazanavir administered as a single 300 mg capsule relative to two atazanavir 150 mg capsules in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects between the ages of 18 to 50 years old with a body mass index (bmi) of 18 to 30 kg/m² * prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (wocbp) must have a negative pregnancy test.
a study to assess disease activity in adult participants with axial spondyloarthritis who receive upadacitinib in a real-world setting

Conditions: Axial Spondylarthritis (r-axSpA)

Summary: axial spondyloarthritis (axspa) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. the most frequent axspa symptom is chronic, often inflammatory back pain that might be difficult to distinguish from other causes of chronic back pain. many participants report persistent pain, including back pain, which impacts disease activity and and impairs quality of life while evoking typical disease burden such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. this study will assess the real-world effectiveness of upadacitinib on early and sustained disease control, and the association between pain and clinical/patient-reported outcomes in axspa participants. upadacitinib is being developed for the treatment of axspa. approximately 352 adult participants with active axspa will be enrolled in germany. participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. the overall duration of the study is approximately 52 weeks. there may be a higher burden for participants in this study compared to usual standard of care due to study procedures. participants will attend regular visits per routine clinical practice. the effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of axspa upon physician's judgement. * physician decision on participant treatment with upadacitinib must have been reached prior to and independently of recruitment in the study. * upadacitinib prescribed in accordance with the local label. exclusion criteria: * prior exposure to any janus kinase (jak) inhibitor (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib). * participants with primary fibromyalgia (upon physician´s judgement) * participation in a clinical trial of an investigational drug, concurrently or within the last 30 days or five half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study. * participants who cannot be treated with upadacitinib according to the applicable local label.

Keywords: axial spondylarthritis (axspa) upadacitinib rinvoq
healing of ischemic leg ulcers in patients treated with isoniazid

Conditions: Arterial Leg Ulcer

Summary: the main objective of this trial is to study the healing effect of an oral drug (isoniazid) in patients with ischemic (arterial) leg ulcers defined by a systolic toe pressure \<40 mm hg.

treatment of arterial ulcers is problematic. previous pharmaceutical interventions with for example prostaglandins have produced only limited beneficial effects but have been associated with frequent adverse effects. positive effects of isoniazid have been observed in a preclinical model of ischemic wound healing (weinreich et al. surgery 2010).

Eligibility criteria:
inclusion criteria: * patients with ischemic leg ulcers unsuitable for vascular surgical intervention * systolic toe pressure \< 40 mm hg * ulcer duration \> 3 months * ulcer area: 1-20 cm2 * written informed consent exclusion criteria: * b-hb \< 6 mmol/l * aspartate transaminase \> 50 u/l * diabetes mellitus \> 10%hba1c * usage of more than 10 mg prednisolone daily within the last 30 days * usage of cytotoxic agents with the last 3 months * usage of rifampicin, phenytoin, carbamazepin, theophylline, benzodiazepines (diazepam, triazolam), stavudine and/or valproat * alcohol abuse * hereditary galactose intolerance * hypersensitive to isoniazid or for one or more of the filling substances (magnesium stearate, povidone, talcum, lactose and starch) * cellulitis or deep infection (osteomyelitis and/or tendonitis) related to the ulcer * gangrene * participation in clinical trials within the last 7 days * pregnancy or breastfeeding * women of child bearing potential who decline to use contraception
comparison of insulin therapy in treating post-transplant diabetes

Conditions: Diabetes Mellitus

Summary: to determine if the use of insulin isophane results in improved control of blood sugars compared to the use of insulin glargine in new onset diabetes after kidney, lung, or heart transplantation (nodat).

a large percentage of organ transplant recipients develop de novo diabetes mellitus after transplantation, also called "new onset diabetes after transplant" or nodat. the cause of the diabetes appears to be commonly used anti-rejection medications, particularly calcineurin inhibitors and glucocorticoids. management of glucose levels in nodat often requires insulin therapy. standard practice is to start long-acting insulin. however, patients with nodat often exhibit fasting morning glucose levels that are relatively low compared to pre-lunch and pre-dinner glucose levels. this seems to make nodat patients more susceptible to fasting, or morning, hypoglycemia on long-acting insulin analogues than non-transplant patients with type ii diabetes. this phenomenon of morning hypoglycemia in nodat often limits the up-titration of basal insulin resulting in suboptimal treatment of hyperglycemia later in the day. because of this pattern, transplant patients may respond better to morning insulin isophane (intermediate acting) than to long-acting insulin glargine preparations. our trial is designed to compare morning nph insulin (isophane insulin) with conventional therapy of basal glargine insulin on both continuous blood glucose levels and hemoglobin a1c (glycosylated hemoglobin).

Eligibility criteria:
inclusion criteria: 1. must be followed by the inova fairfax hospital transplantation program for post-transplant care 2. diabetes mellitus inadequately responsive to lifestyle modification and non-insulin hypoglycemic medication 3. need for subcutaneous insulin therapy (after discontinuation of iv insulin therapy, if it was required) 4. ability to read consent form and give consent in english. exclusion criteria: 1. use of insulin or non-insulin hypoglycemic medication before transplantation 2. cystic fibrosis patients 3. age \< 18 years of age 4. pregnancy 5. non-english speaking subjects

Keywords: post-transplant diabetes mellitus renal transplant kidney transplant lung transplant heart transplant insulin
spi-62 as a treatment for adrenocorticotropic hormone-dependent cushing's syndrome

Conditions: Cushing's Syndrome I; Cushing Disease Due to Increased ACTH Secretion; Cortisol Excess; Cortisol; Hypersecretion; Cortisol Overproduction; Ectopic ACTH Secretion

Summary: this is a randomized, placebo-controlled, study of spi-62 in subjects with acth-dependent cushing's syndrome caused by a non-adrenal tumor. subjects will receive each of the following 2 treatments for 24 weeks: spi-62 and matching placebo with the option of long-term extension.

this is a multicenter, randomized, placebo-controlled, phase 2 study to evaluate the pharmacologic effect, efficacy, and safety of spi-62 in subjects with acth-dependent cushing's syndrome. each subject who provides consent and meets all inclusion and exclusion criteria will participate in a screening period (days -35 to -8), a baseline period (days -7 to -1), and a treatment period (day 1 of week 1 to day 168 ± 3 days of week 24) and, the option of long-term extension. subjects have the option to continue with the study on active study drug and return to the site every 3 months for blood tests and study drug dispensing. the visits may be conducted remotely if testing can be arranged.

Eligibility criteria:
inclusion criteria: * male or non-menstruating female * 18 years or older * active and consistent cortisol excess * documented diagnosis of acth-dependent cushing's syndrome including cushing's disease, ectopic acth secretion, and ectopic crh secretion. exclusion criteria: * recent (within 6 weeks) surgery for cushing's or surgery planned within 24 weeks of randomization. * history of any fractionated radiation therapy for cushing's within the past 2 years or conventional radiation therapy within 4 years. * history of bilateral adrenalectomy or exogenous, pseudo, cyclic, or non-acth-dependent cushing's syndrome (including certain inherited conditions). * high risk of acute morbidity from corticotroph adenoma growth (similar to that which occurs with nelson's syndrome) defined as current evidence of macroadenoma at risk of impingement of vital structures. * any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the study or the evaluation of its results, including but not limited to poor venous access or recent receipt or donation of blood products. * women who are currently pregnant, lactating or planning fertility and unwilling to adhere to approved contraceptives or abstinence.

Keywords: cushing's syndrome acth secretion cushing's disease excessive cortisol secretion cortisol ectopic crh secretion
virtual body project groups led by peers versus clinicians

Conditions: Eating Disorders; Body Image

Summary: eating disorders (eds) are a group of illnesses associated with significant psychological and physiological consequences. overall, only 20% of individuals with eds receive treatment and treatment is effective for only about 25-35% for those who receive care. the development and implementation of effective prevention approaches for those at risk is therefore pivotal. the body project is the most effective ed prevention program for at-risk females according to meta-analyses, but reach has been limited since delivery has traditionally been in-person. further research is warranted to examine cost-effective and easily accessible approaches to increase scalability and potential for broad implementation. with this application, the investigators therefore propose to examine the effectiveness of the body project in young females, a high-risk group, with the following main novel aspects: i) virtually-delivered body project groups to maximize reach; ii) peer-led versus clinician-led virtually-delivered body project groups; iii) the inclusion of objective measures to assess engagement of intervention targets (i.e., mediator).


Eligibility criteria:
inclusion criteria: * age 16-25 * female identifying * self-reported body image concerns exclusion criteria: * ongoing eating disorder diagnosis requiring treatment or hospitalization

Keywords: prevention body acceptance
a clinical study of mk-6194 for the treatment of vitiligo (mk-6194-007)

Conditions: Non-segmental Vitiligo

Summary: researchers are looking for a new way to treat people with non-segmental vitiligo (nsv). the goal of this study is to learn about the safety of mk-6194 and how well people tolerate it. researchers also want to learn if people who take mk-6194 have more of a decrease in the amount of vitiligo on their face compared to people who take placebo.


Eligibility criteria:
inclusion criteria: * has a clinical diagnosis of non-segmental vitiligo * has non-segmental vitiligo with disease duration of at least 6 months * has depigmentation contributing to facial vitiligo area scoring index (f-vasi) ≥ 0.3 at screening and baseline * has depigmented facial body surface area (bsa) ≥0.3% at screening and baseline * has total vitiligo area scoring index (t-vasi) ≥4 at screening and baseline * has total body vitiligo area ≥4% at screening and baseline excluding hands and feet involvement exclusion criteria: * has segmental vitiligo * has ≥50% leukotrichia on face or body * has any other dermatological diseases that would interfere with vitiligo assessments * has history of or current inflammatory condition other than vitiligo that, in the opinion of the investigator, could interfere with the evaluation of vitiligo * has a known systemic hypersensitivity to interleukin 2 (il-2), or modified il-2 including mk-6194, or its inactive ingredients * has an active or clinically significant infection requiring hospitalization or treatment with iv anti-infectives within 4 weeks prior to randomization, or oral/intramuscular anti-infective therapy within 2 weeks prior to randomization * has symptomatic heart failure (new york heart association class iii or iv) or myocardial infarction or unstable angina pectoris within 6 months prior to screening * has a severe chronic pulmonary disease requiring oxygen therapy * has a transplanted organ, which requires continued immunosuppression * has a history of any malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix * has evidence of active tuberculosis (tb), latent tb, or inadequately treated tb * has confirmed or suspected covid-19 infection * has history of drug or alcohol abuse within 6 months prior to screening * has had major surgery within 3 months prior to screening or has a major surgery planned during the study * has had an inadequate response (as evaluated by a dermatologist or local physician specialist equivalent) to previous treatment with a janus kinase inhibitor (jaki) after an appropriate treatment duration (eg, ≥12 weeks) * has received prohibited medications within protocol-specified timeframes prior to randomization * has participated in another investigational clinical study within 4 weeks prior to randomization * has donated or lost ≥1 unit of blood (approximately 500 ml) within 4 weeks prior to the screening visit * has received cosmetic or other procedures that could interfere with evaluation of vitiligo during the study
re-examination study for varivax (v210-059 am2)

Conditions: Varicella

Summary: this survey is conducted for preparing application materials for re-examination under the korean pharmaceutical affairs laws and its enforcement regulation; its aim is to reconfirm the clinical usefulness of varivax through collecting the safety information according to the re-examination regulation for new drugs.

this post-marketing survey was conducted in the usual routine practice and the investigator enrolled participants vaccinated with varivax continuously after study start. the purpose of the study was to assess the occurrence of adverse events and to identify factors that may affect the safety of the vaccine under real-life, post-marketing conditions. no hypothesis testing was conducted in this survey.

Eligibility criteria:
inclusion criteria: * participants must be vaccinated with varivax as a standard of care exclusion criteria: * participants who have been previously vaccinated with varivax * contraindication with varivax

Keywords: varicella
pulmonary rehabilitation for rural patients with copd

Conditions: Chronic Obstructive Pulmonary Disease (COPD

Summary: the purpose of this study is to test the uptake, effectiveness, and patient-caregiver-provider experience of a crucial treatment not provided in rural areas: pulmonary rehabilitation.


Eligibility criteria:
inclusion criteria * 40 years of age or older * physician-diagnosed copd * living in a rural area defined by rural-urban commuting area codes 4-10 * mmrc score\>=1 * english speaking exclusion criteria * inability to walk (orthopedic/neurologic/cardiac limitation causing immobility) * cognitive impairment or inability to understand and follow instructions. * patients with no copd symptom burden, no breathlessness (mmrc score 0), as based on our previous studies they usually perceive no benefit from pr and do not have compliance with pr. * traditional center-based pr was completed within 3 months of initial study recruitment. * transition to hospice or end-of-life care at the time of screening. * acute exacerbation at the time of screening.
effect of hypertonic sodium chloride on urinary biomarkers in healthy subjects and patients with chronic kidney disease

Conditions: Nephropathy

Summary: patients with chronic kidney disease (ckd) have a defect in the tubular reabsorption of sodium, and therefore the ability to excrete a sodium load is diminished compared to healthy subjects. urinary biomarkers reflects the water- and sodium-channel activity in the kidney and may be measured after an infusion with hypertonic saline in ckd patients and healthy subjects.

the fractional sodium excretion is elevated as high as 10-20% in patients with chronic kidney disease (ckd) changes in the sodium intake results in a slower expansion and/or reduction in extracellular fluid in ckd patients. urinary biomarkers reflects the kidneys transport of sodium and water in the nephron. changes in the sodium-and water channel activity is induced by intervention with hypertonic saline (3.0%) the change in sodium-and water channel activity is followed by change in extracellular and intracellular fluid compartments and the plasma concentration of vasoactive hormones. the purpose of this study is to investigate the changes in urinary biomarkers (u-nkcc2, u-enac-gamma and u-aqp2), the activity of the sodium-and water channels, the extra- and intracellular fluid compartments and the plasma concentration of vasoactive hormones in patients with ckd and in healthy subjects. subjects and patients are examined during one examination day. four days prior to the examination day the subjects consume a standardized diet based on the amount of sodium and calories. on the examination day the subjects receive an infusion with hypertonic saline. renal function is measured by renal clearance of 51cr-edta. urinary biomarkers (u-nkcc2, u-enac-gamma and u-aqp2) are measured to evaluate the activity of sodium channels in the nephron and changes in fluid compartments are measured by body composition monitor.

Eligibility criteria:
inclusion criteria: 1. healthy subjects * healthy males and females * age 18-70 * bmi range 18,5-30,0 kg/m2 2. patients with ckd * age 18-70 * egfr 15-60 ml/min * bmi range 18.5 - 30.0 kg/m2 exclusion criteria: 1. healthy subjects * hypertension (ie ambulatory bp \>130 mmhg systolic or/and \>80 mmhg diastolic) * history or clinical significant signs of heart, lung, liver, kidney, endocrine, brain or neoplastic disease. * alcohol abuse * drug abuse * smoking * pregnancy or nursing * blood donation within a month prior to examination * medical treatment apart from oral contraception 2. patients with chronic kidney disease * clinical significant signs of heart, lung, liver, endocrine, brain or neoplastic disease. * diabetes * immunosuppressive medications * smoking * alcohol abuse * drug abuse * pregnancy or nursing

Keywords: nephrology chronic kidney disease sodium-channels water-channels bcm
car-t cells in the treatment of malignant hematological tumors

Conditions: Lymphoma, B-Cell; Leukemia, B-cell; Leukemia, T-Cell; Multiple Myeloma

Summary: to evaluate the safety of autologous car-t cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

main research objective: to evaluate the safety of autologous car-t cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors. secondary research objective: to investigate the efficacy and cytodynamic characteristics of autologous car-t cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

Eligibility criteria:
1. with the consent of himself or the legal guardian and the signed informed consent, he is willing and able to comply with the planned visit, research and treatment, laboratory examination and other test procedures; clinical study of car-t technique in the treatment of recurrent and refractory hematopoietic and lymphatic tumor 2. patients with recurrent and refractory hematopoiesis and lymphoid tissue tumors determined by clinical diagnosis; 3. age 14-70 (including boundary value), both male and female; 4. subjects with a physical status of 0\~2 in the american eastern oncology collaboration group (ecog); 5. the results of treatment related antigens were positive; 6. the expected life span is more than 3 months from the date of signing the informed consent;

Keywords: t cells