Kornimate/medical-research-clean huggingface dataset:
impact of sglt2 inhibitors in heart transplant recipients

Conditions: Transplant; Failure, Heart; Cardiac Allograft Vasculopathy; Rejection Heart Transplant

Summary: the goal of this clinical trial is to test if sglt2 inhibitors could prevent or delay the development of cardiac allograft vasculopathy (cav) post-heart transplantation (txc). the main questions it aims to answer are: primary outcome: cav, according to ishlt grading system diagnosed by ccta; secondary outcomes: cardiovascular death, all-cause mortality, hospitalization, worsening glomerular filtration rate, fasting glucose, weight, and blood pressure. exploratory and safety outcomes: rejection, hypoglycemia, urinary tract infection, hypovolemia, and limb amputation. hypothesis the null hypothesis is that sglt2 inhibitors do not reduce the incidence of cav in transplanted patients. the alternative hypothesis is that sglt2 inhibitors reduce the incidence of cav in transplanted patients.methodology study design a randomized clinical trial of superiority with active control (2 arms), with central randomization and blinded evaluation of outcomes, to evaluate the efficacy and safety of adding dapagliflozin or empagliflozin 10 mg once daily to conventional post-txc treatment compared with the treatment of isolated conventional post-txc for 6-8 months. study sample sample: all adult patients undergoing a heart transplant between january 2017 and december 2023 at hospital de messejana. inclusion criteria included: patients of both sexes, aged ≥ 18 years, who have undergone heart transplantation between january 2017 and december 2023 and are under the care of the heart transplant and heart failure unit at hospital de messejana.


Eligibility criteria:
inclusion criteria: patients of both sexes, aged ≥ 18 years, who have undergone heart transplantation between january 2017 and december 2023 and are under the care of the heart transplant and heart failure unit at hospital de messejana. exclusion criteria: patients who refuse to participate in the study, those with known hypersensitivity or intolerance to isglt2, individuals with type 1 diabetes mellitus, symptoms of hypotension, or systolic blood pressure below 80 mm hg, an estimated glomerular filtration rate (egfr) below 20 ml per minute per 1.73 m2 of body surface area, and pregnant women

Keywords: heart transplantation cardiac allograft vasculopathy rejection
cthrc1 abiomarker in rheumatoid arthritis diagnosis

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to determine whether plasma levels of the collagen triple helix repeat containing (cthrc1) protein can serve as a blood-based biomarker for diagnosis of rheumatoid arthritis (ra) ,and furthermore its correlation with disease activity.

rheumatoid arthritis (ra) is a chronic, progressive, autoimmune disease of synovial joints. characterized by periods of flares with high disease activity involving both a systemic immune response and tissue-specific inflammatory events that can lead to erosive joint and bone destruction and subsequent disability . currently, diagnosis of ra is based mainly on the extent of tenderness and swelling of the joints , levels of acute-phase reactants such as c-reactive protein (crp) ,erythrocyte sedimentation rate(esr) , high titers of rheumatoid factor (rf) and high titers of antibodies against cyclic citrullinated peptide (anti-ccp) in the plasma .of interest, cthrc1 is a secreted modulator of wnt signaling, which is a key regulator of joint remodeling, and promotes cell proliferation and migration. therefore, cthrc1 may contribute to multiple aspects of the pathogenic fls behavior in ra and modulate processes that promote synovial hyperplasia and invasion.the expression pattern of cthrc1 in pannus, its role in the function of fls relevant to cartilage damage in ra, and cthrc1's association with disease severity in murine arthritis raised the question of whether cthrc1 could be used as a marker for ra diagnosis and monitoring of disease activity in patients

Eligibility criteria:
inclusion criteria: * -patients diagnosed as ra. * patients ( \>18)who are age and sex matched with the controls exclusion criteria: . other rheumatologic diseases. .patients with malignancy . .patients with hepatic disease .
study of axicabtagene ciloleucel given with steroids in participants with relapsed or refractory large b-cell lymphoma

Conditions: Relapsed or Refractory Large B-cell Lymphoma

Summary: the goal of this clinical study is to learn more about the study drug, axicabtagene ciloleucel, in participants with relapsed or refractory large b-cell lymphoma (lbcl) in the outpatient setting.

participants who complete at minimum 24 months follow up will be transitioned to a separate long-term follow-up study (study kt-us-982-5968) to complete the remainder of the 15-year follow-up assessments.

Eligibility criteria:
key inclusion criteria: * histologically confirmed large b-cell lymphoma (lbcl), including the following types defined by world health organization (who) 2016 classification, by local pathology laboratory assessment, are eligible as defined below: * diffuse large b-cell lymphoma (dlbcl) not otherwise specified. * high-grade b-cell lymphoma (hgbl) with or without myc and bcl2 and/or bcl6 rearrangement. * dlbcl associated with chronic inflammation; epstein-barr virus (ebv) + dlbcl. * primary mediastinal (thymic) lbcl. * primary cutaneous dlbcl, leg type. * transformation of follicular lymphoma to dlbcl will also be included. * relapsed or refractory disease after 1 or more lines of therapy. * individuals must have received adequate prior therapy including: * anti-cd20 monoclonal antibody and * an anthracycline-containing chemotherapy regimen. * at least 1 measurable lesion according to the lugano response criteria for malignant lymphoma. lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * individual agrees to outpatient treatment setting and to adhere to the prespecified clinical monitoring requirements. key exclusion criteria: * history of autologous or allogeneic stem cell transplant. * prior cluster of differentiation (cd)19 targeted therapy. * prior chimeric antigen receptor therapy or other genetically modified t-cell therapy. * presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (iv) antimicrobials for management. simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the kite medical monitor. * individuals with detectable cerebrospinal fluid malignant cells, brain metastases, or with a history of central nervous system (cns) lymphoma or primary cns lymphoma. dlbcl epidural involvement should be considered as positive cns disease. * in the investigator's judgment, the individual is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation. note: other protocol defined inclusion/exclusion criteria may apply.
the relationship between sleep disorders and cytokine levels among hemodialysis and peritoneal dialysis patients

Conditions: Renal Failure; Sleep Disorder; Hemodialysis; Peritoneal Dialysis

Summary: sleep disorders are common in patients with end-stage renal disease on both hemodialysis and peritoneal dialysis and are associated with significant medical, psychological and social disturbances. numerous factors have been suggested as contributing to or associated with the high prevalence of sleep disturbance in this population. increasing evidence suggests that cytokines are involved in the regulation of sleep and wakefulness and that the communication between the sleep and the immune system is bi-directional. blood-dialyzer or peritoneum-dialysate interaction during dialysis therapy has the potential to activate mononuclear cells leading to production of inflammatory cytokines. these cytokines are believed to play a significant role in dialysis-associated morbidity and mortality. nevertheless, a cytokine overproduction may alter sleep pattern in chronic dialyzed patients, thus explaining the presence of sleep disorders in these patients. in the other way, sleep loss may have effects on immune process and secretion of cytokines in chronic dialyzed patients. the purpose of this study was to examine the relationship between quality of sleep and serum cytokine levels in hemodialysis and peritoneal dialysis patients.


Eligibility criteria:
inclusion criteria: * esrd patients with hemodialysis or peritoneal dialysis exclusion criteria: * malignancy, hospitalization, infection, inflammation
ethnic variations in antidepressant response

Conditions: Depression

Summary: this 11-week study aims to determine how genetic factors affect the way african americans and caucasians with major depression respond to antidepressant medication \[citalopram (celexa®)\].

depressed patients vary substantially in their responses to antidepressants. genetic factors may account for a large part of these differences in response. this study will include both african americans and caucasians to examine the role of genetic factors in treatment response. participants receive citalopram (celexa) for 8 weeks and a placebo for 1 week. visits occur once a week for 11 weeks. a variety of interviews, scales, tests, and questionnaires are used to assess participants.

Eligibility criteria:
inclusion criteria: * dsm-iv criteria for major depression * african-american or caucasian ethnic background (both parents and 3 out of 4 grandparents) exclusion criteria: * schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression, or bipolar disorder * current drug abuse or history of drug abuse within the past 6 months * unstable medical or neurological conditions that interfere with the treatment of depression * allergy to citalopram * failure to respond to adequate citalopram drug trial (40 mg for at least 6 weeks) * seizure disorder * pregnancy * psychotropic medications, including antidepressants and neuroleptics * suicidal ideation or other safety issues * fluoxetine (prozac) or maois (nardil, parnate) in the last 2 months * ongoing cognitive behavioral therapy or intensive psychotherapy. general talk therapy is acceptable

Keywords: depressive disorder
novel endovascular access trial (neat)

Conditions: Chronic Kidney Disease

Summary: the objective of this study is to evaluate the safety and efficacy of the flex system when used to create an arteriovenous fistula (avf or av fistula) percutaneously in patients with chronic kidney disease (ckd) who require hemodialysis vascular access.

this is a 12 month multi-center non-randomized investigational study to evaluate the safety and efficacy of the flex system to create an endovascular avf in patients with ckd who require hemodialysis vascular access.

Eligibility criteria:
inclusion criteria: * eligible for a native surgical arteriovenous fistula, as determined by the treating physician. * adult (age \>18 years old). * established, non-reversible kidney failure requiring hemodialysis. * written informed consent obtained. exclusion criteria: * functioning surgical access in the planned treatment arm. * pregnant women. * new york heart association (nyha) class iii or iv heart failure. * allergy to contrast dye.

Keywords: arteriovenous fistula fistula chronic kidney disease percutaneous kidney disease kidney failure, chronic urologic diseases renal insufficiency, chronic renal insufficiency ckd hemodialysis
iamhealthy parents first: a televideo parent and child obesity program for rural families

Conditions: Weight Loss; Pediatric Obesity

Summary: the purpose of this study is to assess whether providing a parent-only group program before providing a parent and child group program works better than the parent and child group program alone.

the goal of this project is to determine if an adult intervention followed by a family-based program (iamhealthy parents first) will result in a larger percentage of weight loss in parents and children compared to solely a family-based program (iamhealthy). furthermore, the investigators aim to discover if administering iamhealthy parents first will improve dietary intake, physical activity, and weight-related quality of life among parents and children when compared to iamhealthy. parent/child dyads will be recruited from rural elementary schools, medical clinics, and organizations across kansas and neighboring states.

Eligibility criteria:
inclusion criteria: * family lives in a rural area (city and/or county population \<20,000) or as defined by ruca codes, urban influence codes, amount of agricultural income, or individual commuting patterns * child bmi%ile ≥ 85th and parent bmi 25-50 kg/m2 * child in 1st-5th grade or 6-11 years of age * child and parent speak english * family is available at times intervention is offered exclusion criteria: * for parents: new mi, stroke or cancer diagnosis in past 6 months, recent bariatrics surgery (within 2 years) or planned within 1 year, pregnancy in last 6 months or planned within 1 year
the effectiveness of abt-450/r - ombitasvir, ± dasabuvir, ± ribavirin in patients with chronic hepatitis c -an observational study in ireland

Conditions: Chronic Hepatitis C

Summary: the interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir with or without dasabuvir (abbvie regimen) ± ribavirin (rbv) for the treatment of chronic hepatitis c (chc) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions. this observational study was the first effectiveness research examining the abbvie regimen ± rbv, used according to the local label, under real world conditions in ireland in a clinical practice patient population.

this was a prospective, multi-center observational study in participants receiving the interferon-free abbvie regimen ± rbv in ireland. the prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study. adults chronically infected with hcv, receiving the interferon-free abbvie regimen, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites. follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice. data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with a treatment duration of 24 weeks), end of treatment (eot), early post- treatment and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment \[svr12\] and sustained virologic response 24 weeks after the end of treatment \[svr24\]).

Eligibility criteria:
inclusion criteria: * treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis c (chc), genotype 1, receiving combination therapy with the interferon-free abbvie regimen ± ribavirin (rbv) according to standard of care and in line with the current local label * if rbv was co-administered with the abbvie regimen, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy) * participants had to voluntarily sign and date an informed consent form prior to inclusion into the study * participants must not have participated or intended to participate in a concurrent interventional therapeutic trial exclusion criteria: - none

Keywords: real world effectiveness observational study sustained virologic response chronic hepatitis c chronic hepatitis c genotype 1 ombitasvir/paritaprevir/ritonavir ± dasabuvir
the application value of stic in the diagnosis of fetal complex congenital heart disease

Conditions: Congenital Heart Disease

Summary: the objective of this study is to use of stic technology to assist the traditional echocardiography to diagnose the fetal congenital heart disease accurately and then to provide a basis for prenatal counseling.

this is a diagnostic test in shanghai xinhua hospital from nov.2016 to dec.2017. 265 cases are gravidas with fetal congenital heart disease diagnosed by echocardiography.only gravidas who are willing to have complete pregnancy checks and finally delivery or abortion in the hospital are interviewed are eligible for the study. study participants will be asked for their informed consent.we collect their fetal 2d echocardiography and stic images every 4-6 weeks during pregnancy and 1 weeks after the baby giving birth we finish their neonatal echocardiography.

Eligibility criteria:
inclusion criteria: 1. gravida with singleton pregnancy taking fetal echocardiography. 2. no virus infection or drug use history, no harmful substances in the early pregnancy. 3. complete pregnancy check in the hospital, and finally delivery or abortion in the hospital. 4. on the basis of informed consent，willing to cooperate with our group. exclusion criteria: 1. elderly pregnant women (\>35 years old) 2. twin or multiple pregnancy 3. pregnant women suffering from mental illness, can't take care of themselves. 4. fetus diagnosed with other abnormalities (except congenital heart defects)

Keywords: spatio-temporal image correlation complicated congenital heart disease echocardiography
ipsihand device use in stroke patients to assess functional motor outcomes

Conditions: Stroke

Summary: this study aims to evaluate the impact of the neurolutions upper extremity rehabilitation system, known as ipsihand, on improving functional motor control for post-stroke patients with hemiparesis. the neurolutions system is a brain-computer interface (bci) comprised of a robotic orthosis, worn on the hand and wrist, and operated by the patient's brain waves which are measured by eeg electrodes. the system also utilizes a tablet interface to provide therapy instructions to the patient.

participants will complete 12 weeks of home therapy with the neurolutions ipsihand system. outcomes will be based on a comparison of the patient's baseline measurements to post-therapy assessments.

Eligibility criteria:
inclusion criteria: * 6-months or more post stroke * presentation of upper extremity hemiparesis or hemiplegia * participants must english speaking * demonstrate intact cognition to provide informed consent * botox injections are allowed, and must continue regimen at regular intervals throughout the study exclusion criteria - * not active in another clinical study * not receiving formal therapy for the upper extremity * no use of other modalities or technologies to the upper extremity * cognitive impairment: short blessed test score 9 or above * significant spasticity: modified ashworth scale score 3 or more at the elbow * significant hemispatial neglect: mesulam cancellation test 3 or more unilaterally * insufficient strength: motricity index score for shoulder abduction 18 - any contractors of the affected upper extremity that would not allow the ipsihand robotic exoskeleton to be worn comfortably and/or safely for device use

Keywords: rehabilitation brain-computer interface
geographic atrophy long-terms outcomes study

Conditions: Geographic Atrophy

Summary: the purpose of this study is to describe functional and long-term clinical outcomes of patients with a diagnosis of geographic athrophy secondary to age related macular degenaration in clinical practice


Eligibility criteria:
inclusion criteria: inclusion criteria for patients: * aged 60 years or over at the time of ga diagnosis * patients providing informed consent to participate in the study; if the patient is physically incapable of completing the electronic consent form, the form can be completed by a legally acceptable representative of the patient (including an impartial witness, where required) * patients first diagnosed with ga in at least 1 eye between 3 and 10 years prior to index date * for patients with unilateral ga, the other eye should show signs of amd (i.e., the non-ga eye should present with at least drusen, reticular pseudodrusen, or wet-amd) inclusion criteria for caregivers: * aged 18 years or over at the time of consent * caregivers who self-identify as the primary caregiver for a patient for whom documented informed consent for inclusion in the study has been obtained exclusion criteria: exclusion criteria for patients: * patients diagnosed with ga due to causes other than amd (e.g., monogenetic macular dystrophies \[stargardt disease, other\], toxic maculopathies) in either eye * ga with any concurrent intraocular condition that in the opinion of the treating physician would require surgical or intravitreal intervention (for the prevention or treatment of visual loss) during the study or might impact the interpretation of routine clinical assessments e.g., glaucoma, cataract, proliferative diabetic retinopathy. patients first diagnosed with ga less than 3 years prior to the date of consent * patients who have not attended a healthcare institution for the management of ga following diagnosis of ga (a minimum of 2 routine clinical visits for monitoring of ga that included assessment of at least bcva should be documented in the medical records) * patients who have been enrolled in an interventional clinical trial in which they received medication for any retinal condition (note: patients with bilateral ga should be excluded only if both eyes received the pharmacological intervention) exclusion criteria for caregivers: * caregivers for whom documented informed consent has not been obtained for participation in the galtos survey * caregivers with any significant mental incapacity that would prevent them from participating in the survey * paid caregivers

Keywords: ga outcomes
therapeutic effects of combination tape in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: taping is a non-invasive technique that has been used for various musculoskeletal conditions, including knee oa. however, there is limited research on the effects of combination taping techniques on disability, functional capacity, and knee isokinetic torque in patients with knee oa.

osteoarthritis (oa) is a common chronic condition, characterized by progressive loss of joint cartilage, leading to joint pain, stiffness, and functional disability. knee oa is one of the most prevalent forms of oa, affecting millions of people worldwide. various non-surgical treatment options have been reported, one of them is taping techniques. combination taping is a unique treatment option, where two different types of taping is applied. however, there is limited research on the effects of combination taping techniques on disability, functional capacity, and knee isokinetic torque in patients with knee oa. so this study will be conducted to explore therapeutic effects in individuals who are suffering from knee oa

Eligibility criteria:
inclusion criteria: * second degree knee osteoarthritis exclusion criteria: * sever obesity, sever osteoarthritis, history of knee surgery, allergy to the tape

Keywords: combination taping osteoarthritis