Kornimate/medical-research-clean huggingface dataset:
late cardiac evaluation of the three arm belgian trial involving node-positive early breast cancer patients

Conditions: Breast Cancer

Summary: late cardiac evaluation of the three arm belgian trial a phase iii randomized trial involving node-positive early breast cancer patients with a long median follow-up (\~ 15 years) objectifs primary: • to compare the incidence of late cardiac events between anthracycline and non-anthracycline chemotherapy given to node-positive breast cancer patients in the belgian three arm randomized clinical trial secondary: * to compare the late incidence of cardiac events between higher and lower dose anthracycline treated node-positive breast cancer patients; * to compare anthracyclines (higher and lower doses) and non-anthracycline chemotherapy for: * left ventricular diastolic function assessed by echo * exercise capacity assessed by 6-minute walk test (6mwt) * cardiac morphology (myocardial inflammation or injury, fibrosis, lvef) assessed by mri * serum cardiac biomarkers (bnp and tnt) * patient-reported cardiac symptoms * patient-reported cardiac symptoms assessed by qol questionnaires are associated with subclinical findings on lvef assessment * cognitive function, functional autonomy, and psychological distress

the primary objective of this study is to compare the incidence of cardiac events \[(defined as asymptomatic systolic dysfunction (lvef \< 50%, asymptomatic nyha i) or symptomatic heart failure nyha class ii-iv either by echo and/or by clinical exam (lvef \< 50% and heart failure symptoms)\] between anthracycline and non-anthracycline chemotherapy treated node-positive breast cancer patients in a long-term follow-up. we will define a binary status for each patient: no cardiac event / one or more cardiac events. analysis of the primary endpoint will involve a comparison of the cmf-treated patients versus the pooled anthracycline treated patients (ec and hec). if a significant difference is detected, all paired comparisons will also be performed for the primary endpoint (cmf versus ec, cmf versus hec, ec versus hec).

Eligibility criteria:
inclusion criteria: * alive, free of any recurrence, not lost to follow-up * last workup should be no older than 1 year to exclude relapses. if this is older than 1 year, a new workup (pe, blood tests and mmg) will be performed prior to the entry in this study * patients previously diagnosed with chf who are free of recurrence will also be invited to participate, if there is no contra-indication * patients should be able to perform the prescribed assessments exclusion criteria: * death * breast cancer recurrence * unwilling to perform exams as per protocol

Keywords: cmf hec ec node positive breast cancer
phase 2 study of mm-093 to treat patients with uveitis

Conditions: Uveitis

Summary: the purpose of this study is to evaluate the tolerability, pharmacokinetics, pharmacodynamics, and biologic activity of mm-093 in patients with moderate to severe uveitis.


Eligibility criteria:
inclusion criteria: * aged 18 years and above * understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol - specific procedures being performed. * have been diagnosed with sarcoid or birdshot uveitis * be able and willing to comply with study visits and procedures per protocol. * women of child bearing potential must use medically acceptable means of birth control in an effective manner and agree to continue its use during the study and 6 weeks after the last dose of study drug. * sexually active men must agree to use a medically acceptable form of contraception during the study and continue for 4 weeks after the last dose of study drug. * able to store patient kit/cooler containing study drug in a refrigerator at home. exclusion criteria: * significant concurrent medical diseases including: * cancer or history of cancer, or lymphoproliferative disorder (other than sarcoidosis or successfully resected cutaneous basal or squamous cell carcinoma) within 5 years before the screening visit. * any condition for which participation in this study is judged by the physician to be detrimental to the patient, such as history of significant or unstable cardiac, pulmonary, gastrointestinal, neurological, or psychiatric disease. * significant ongoing infection requiring systemic antibiotic, antifungal, antiviral, or ant anti-mycobacterial therapy. * autoimmune or connective tissue disorder other than sarcoid or birdshot uveitis, (e.g. rheumatoid arthritis, systemic lupus erythematosus, or scleroderma.) * other known active eye diseases or eye infections (bacterial, fungal, or viral) that may interfere with the evaluation of uveitis. * grade 2 or above liver function abnormality * renal disease * any previous history of immunodeficiency syndromes or infection with human immunodeficiency virus (hiv), or a history of hepatitis c or chronic hepatitis b. * live viral or bacterial vaccinations within 3 months prior to screening, or planning to receive such vaccinations during the trial, or up to 3 months after the last injection of mm-093. * pregnant or breastfeeding women or women planning to become pregnant during the study or within 4 weeks after the last dose of the study drug. * scheduled elective surgery during study participation * participated in any previous clinical trials using mm-093 or have any prior exposure to mm-093. * history of severe hypersensitivity to goat, sheep, or cow milk products derived from goat, sheep or cow milk (patients who are lactose intolerant are not excluded.) * any other acute or clinically important condition that the investigator feels would jeopardize the integrity of the study (e.g. a ctcae grade 2 or above clinical finding or laboratory result.)
effect of zydena (udenafil) on cerebral blood flow and peripheral blood viscosity

Conditions: Vascular Dementia; Subcortical Vascular Dementia

Summary: the purpose of this study is to determine whether zydena (udenafil) has effect on cerebral blood flow and peripheral blood viscosity in normal and subcortical vascular cognitive impairment subjects.

udenafil is a newly developed selective phosphodiesterase type 5 inhibitor (pde5i). since pde5i is known to relax smooth muscle cells, it is suggested that pde5i may dilate cerebral vessels and lead to an increase in cerebral blood flow. the main mechanism of subcortical vascular cognitive impairment are hypoperfusion of the brain. therefore, in this study, the investigators will investigate whether udenafil can increase cerebral blood flow and also lower peripheral blood viscosity in normal and subcortical vascular cognitive impairment subjects.

Eligibility criteria:
inclusion criteria: for normal control group * normal cognition by detailed neuropsychological tests * brain mri scan with no or minimal white matter hyperintensities for subcortical vascular mild cognitive impairment (svmci) * clinical diagnosis of svmci * brain mri scan with severe white matter hyperintensities exclusion criteria: - contraindications to phosphodiesterase type 5 (zydena, udenafil)

Keywords: vascular dementia subcortical vascular dementia phosphodiesterase 5 udenafil
study evaluating the safety and efficacy of bapineuzumab in alzheimer disease patients

Conditions: Alzheimer Disease

Summary: this is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate alzheimer disease. patients will receive either bapineuzumab or placebo. each patient's participation will last approximately 1.5 years.


Eligibility criteria:
inclusion criteria: * diagnosis of probable ad, with mmse score of 16-26, and brain mri consistent with the diagnosis of ad * concurrent use of cholinesterase inhibitor or memantine allowed, if stable. * caregiver will participate and be able to attend clinic visits with patient. exclusion criteria: * significant neurological disease other than ad, or a major psychiatric disorder * contraindication to undergo brain mri (e.g., pacemaker, csf shunt, or foreign metal objects in the body) * woman of childbearing potential

Keywords: antibody immunotherapy
cool-it-pro: cryoablation of breast cancer in non-surgical patients

Conditions: Breast Cancer; Cancer of the Breast

Summary: this is a subject registry study of patients who undergo cryoablation for their breast cancer after being determined not to be surgical candidates. data collected as part of this registry will be used to assess the safety of percutaneous ultrasound-guided cryoablation in this population as well as provide long-term follow-up of subjects who received cryoablation.


Eligibility criteria:
eligibility criteria: * diagnosis of breast cancer. * mass must be visible on ultrasound and \> 5 mm from skin. * not undergoing surgery, because: * patient has a medical condition that would not allow sedation or general anesthesia * surgery is not clinically indicated due to unresectable and/or metastatic disease * surgery is not clinically indicated for another reason * patient declines surgery * at least 18 years old. * able to understand and willing to sign an irb-approved written informed consent document.
dantrolene in statin-induced myopathy

Conditions: Statins Induced Myopathy

Summary: statins are one of the most efficient drugs for the treatment of hypercholesterolemia which is considered as one of the main risk factors for atherosclerosis., and therefore they are frequently prescribed medications \[1-2\]. however, statins therapy is associated with myotoxicity. this effect of different severity ranges forms myopathy, myalgia, myositis, and rhabdomyolysis \[3\]. different studies set a number of hypotheses to explain the pathophysiological events of statin-induced myopathy. these hypotheses include disturbance of mitochondrial function resulting in cytoplasmic ca2+ overload as well as decreased level of the potent antioxidant and membrane stabilizer coenzyme q10/ubiquinone \[4-5\] this study tries to introduce a complementary therapy that targets these molecular events. this therapeutic protocol includes dantrolene the muscle relaxant that acts as a ryanodine receptor (ryr) antagonist and thus decreases ca release in cytoplasm.


Eligibility criteria:
inclusion criteria: adults aged 18-75 years currently receiving statin therapy for at least 4 weeks clinical symptoms suggestive of statin-induced myopathy (e.g., muscle pain, weakness) elevated serum creatine kinase (ck) ≥1.5x upper limit of normal able and willing to provide informed consent willing to discontinue statins during the study period (if protocol requires) exclusion criteria: known hypersensitivity to dantrolene history of severe liver disease or abnormal liver function tests (alt or ast \> 2x uln) use of interacting drugs that may increase dantrolene toxicity (e.g., calcium channel blockers like verapamil) renal impairment (e.g., serum creatinine \>2.0 mg/dl) diagnosed neuromuscular disorders unrelated to statins (e.g., als, muscular dystrophy) pregnant or breastfeeding women participation in another clinical trial within the past 30 days
long-term follow-up of ohio state university medical center (osumc) bariatric patients

Conditions: Obesity

Summary: obtain long-term follow-up results for bariatric patients who underwent medical management or surgery for treatment of morbid obesity by ohio state university medical center (osumc).

the purpose of this study is to obtain long-term follow-up results for bariatric patients who underwent medical management or surgery for treatment of morbid obesity by ohio state university medical center (osumc) surgeons during the late 1970s, 1980s, and 1990s. our hypothesis is that surgical intervention for treatment of morbid obesity leads to sustained weight loss and decreased obesity-related morbidity and mortality.

Eligibility criteria:
inclusion criteria: * adult * treated by osumc physicians for obesity * informed consent exclusion criteria: * informed consent not given

Keywords: bariatric surgery long term follow up gastric partitioning surgery roux-en-y gastric bypass surgery obesity
balance in children with cochlear implants

Conditions: Severe, Profound Deafness

Summary: the purpose is to test the balance of children with unilateral,bilateral cochlear implants and patients having unilateral implants before,bilateral implants after surgery,using the bruininks-oseretsky test 2nd ed. to find out if the cochlear implants have an effect.

hearing impairment has a significant impact on individual quality of life and stresses community resources. in the last two decades cochlear implantation has developed into the new standard of care for severe to profound haring loss. recent studies have shown bilateral implantation improves sound localization and understanding of speech in noise. for children, this is seen as a significant benefit. as we begin to offer bilateral cochlear implants to a growing number of children it would be in our patient's best interest to evaluate whether or not this may cause balance impairment. we will evaluate the balance scores of children with bilateral cochlear implants, and compare their results to unilaterally implanted children and a hearing impaired population, with the bruininks-oseretsky test 2nd ed (bot2). in addition we will take a small group of unilaterally implanted patients and test them before and after a contralateral cochlear implant as a prospective study group.

Eligibility criteria:
inclusion criteria: * children with cochlear implant(s) activated for at least two weeks before participation. * children with severe to profound deafness that have not received intervention. exclusion criteria: * children with mental retardation, associated physical handicaps, or chronic sedative use prohibiting completion of the balance tests.

Keywords: balance severe, profound deafness children unilateral/bilateral cochlear implants unilateral cochlear implant bilateral cochlear implants
introducing biosimilar insulin glargine to the treatment regimen of children and youth with type 1 diabetes in mali

Conditions: Type 1 Diabetes (T1D)

Summary: this study aimed to evaluate the impact on blood glucose control and quality of life in children and youth with type 1 diabetes in mali by switching the insulin regimen from human insulin via needle and syringe, to long-acting biosimilar insulin glargine delivered by reusable pens combined with short-acting insulin via needle and syringe.

analog insulins are widely used in middle- and high-income countries. however, use of analog insulin remains limited in lower-income countries due to their increased cost and lack of access, and human insulin remains the mainstay of treatment in these settings. long-acting (basal) analog insulin such as glargine have the benefit of a longer duration (up to 24 hours) and a minimal peak action, and generally, only one injection per day is required. although glargine insulin has been shown to reduce the risk of overnight hypoglycemia, consistent improvement in blood glucose control (measured by hba1c) when compared to human insulin has not been shown, and its impact on quality of life is also inconclusive. furthermore, these studies have all been done in highly resourced countries. life for a child (lfac) has been providing diabetes supplies (insulin, syringes, meters and strips for blood glucose self-monitoring), diabetes-related education, mentoring and technical support to santé diabète in mali since 2008. in 2021, lfac commenced supplying basaglar (glargine) insulin with insulin pen devices (humapen ergo ll). this provided a unique opportunity to investigate the effect of introducing glargine (basaglar) insulin in the low-resource setting of mali, one of the world's poorest countries.

Eligibility criteria:
inclusion criteria: (i) diagnosed with t1d in accordance with world health organization criteria (ii) duration of t1d ≥12 months at time of enrolment (iii) aged \<25 years at time of enrolment (iv) current insulin regimen consisting of humulin nph® and r, or pre-mixed insulin (30/70 r/nph), with no prior use of analogue insulin (vi) willing to regularly self-monitor blood glucose (smbg) levels ≥2 times a day with a blood glucose meter and strips (vii) live in or within one hour's travelling distance of bamako exclusion criteria: (i) previous use of analog insulin

Keywords: children adolescents insulin glargine mali
safety and efficacy of famciclovir in hiv1 positive adults with recurrent genital herpes

Conditions: HIV Positive; Herpes Simplex, Genital

Summary: to determine the efficacy of famvir 500mg bd as suppressive antiviral therapy for acute genital herpes simplex virus (hsv) outbreaks in hiv subjects.


Eligibility criteria:
inclusion criteria: * able to provide signed informed consent * documented hiv infection * in general good health, without other serious medical conditions as deemed by the investigator * male or female over 18 years of age * diagnosed genital hsv (clinical or laboratory) * life expectancy of 12 months or longer per investigator's judgment * stable on famvir 500 mg bd for at least 30 days at time of screening exclusion criteria: * pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (\>5)miu/ml). * women of childbearing potential who are unwilling to use reliable contraception for the duration of the study. * history of hypersensitivity to famvir, its constituents or penciclovir * current use of another antiherpetic medication * recent history of alcohol or drug abuse, which in the opinion of the investigator may interfere with their compliance with study requirements, or who have any other conditions which in the opinion of the investigator would interfere with the successful completion of study procedures * disorder or condition that could interfere with drug absorption, distribution, metabolism or excretion * known or suspected to have or past history of renal dysfunction requiring a dosage modification of famvir 500 bd

Keywords: recurrent genital herpes simplex virus
risk of recurrent venous thrombosis: a validation study of the vienna prediction model

Conditions: Venous Thromboembolism

Summary: because of a high recurrence risk after unprovoked venous thromboembolism (vte) indefinite anticoagulation is recommended, but confers a considerable bleeding risk. it is important to identify patients, in whom the recurrence risk is lower than the expected bleeding risk, and who will not benefit from long term anticoagulation. by use of a scoring model (vienna prediction model), patients can be stratified according to their recurrence risk based on their sex, location of vte and d-dimer. before implementation in routine care, an independent validation is required. patients with unprovoked vte will stop anticoagulation after 3-7 months and the recurrence risk will be estimated by use of the vienna prediction model. low risk patients with a score of \<180 will be included and will be left untreated. patients with a high score will not be included and their management will follow current guidelines. follow-up will be two years and the endpoint will be recurrent symptomatic vte.


Eligibility criteria:
inclusion criteria: age \> 18 years symptomatic uni- or bilateral proximal (including the trifurcation area, popliteal, superficial femoral, deep femoral, common femoral and iliac vein) or distal dvt of the leg and/or symptomatic pe. vte not provoked by one of the following temporary risk factors: surgery, trauma,pregnancy, cancer, immobilisation. exclusion criteria: history of previous vte; anticoagulation for longer than 6 months; reasons for long-term anticoagulation other than vte; poor patient compliance; no consent to participate

Keywords: risk of recurrent
evaluation of a trauma-informed partner violence intervention program

Conditions: Domestic Violence; Post Traumatic Stress Disorder

Summary: the goal of this study is to conduct a randomized controlled trial (rct) comparing outcomes between two programs to reduce intimate partner violence (ipv)- the strength at home (sah) program and a standard, state-approved ipv intervention program, treatment as usual (tau). primary outcomes will include self- and partner-reported physical and psychological ipv. secondary outcomes will include self-reported ptsd symptoms, alexithymia, alcohol use problems, and treatment satisfaction, assessed across five time points.

a mixed-methods approach will be used for this single site, parallel group rct. all participants will be randomized at the individual level to strength at home (sah) or treatment as usual (tau), with a 1:1 allocation ratio. assessments will occur pre-treatment and post-treatment with follow-up assessments scheduled every three months post-treatment through month 12. assessments have been designed to examine reductions in ipv and other outcomes including posttraumatic stress disorder (ptsd) symptoms and alcohol use. the primary hypotheses are that those receiving sah will evidence greater reductions in physical and psychological ipv, symptoms of ptsd, alexithymia, and alcohol use problems, and higher treatment satisfaction relative to those receiving tau across the time points. the specific aims and sub aims are: 1. test the comparative effectiveness of sah and tau by conducting an rct comparing 200 justice-involved men randomly assigned to each program. * compare the frequency of physical and psychological ipv, the primary outcomes of interest, across conditions as reported by the male participants and their intimate partners across time 1 (baseline) and four 3-month follow ups (times 2-5). additionally, at time 5, the study may make use of available arrest record data from the state of rhode island. * compare symptoms of ptsd, alexithymia, and alcohol use problems across conditions and assessment time points as reported by the male participants. * compare treatment satisfaction across conditions as reported by the male participants across the four 3-month follow ups (times 2-5). 2. facilitate future use of sah by working closely with the stakeholder advisory board to identify potential barriers and facilitators to successful implementation in civilian community settings. * identify barriers and facilitators to implementation. * assess the acceptability of sah among stakeholders in the community setting and areas in need of refinement.

Eligibility criteria:
inclusion criteria: * men court-mandated to ipv intervention from the rhode island department of parole and probation and their partners exclusion criteria: * none

Keywords: strength at home (sah) group intervention motivational strategies justice-involved men alcohol use alexithymia