Kornimate/medical-research-clean huggingface dataset:
effect of metoprolol in post alcohol septal ablation patients with hypertrophic cardiomyopathy

Conditions: Hypertrophic Cardiomyopathy

Summary: in this trial, the investigators will assess the effect of metoprolol in patients with hypertrophic cardiomyopathy who underwent alcohol septal ablation. the investigators will evaluate the quality of life, exercise tolerance, echocardiographic parameters and laboratory marker of heart failure and myocardial injury.

in this trial, the investigators will assess the effect of metoprolol in patients with hypertrophic cardiomyopathy who underwent alcohol septal ablation. the investigators will evaluate the quality of life, exercise tolerance, echocardiographic parameters and laboratory marker of heart failure and myocardial injury. the investigators will enroll 50 patients that will meet all the inclusion criteria and will agree to participate in the trial. in patients with preceding beta-blocker medication, it will be discontinued and a washout period of one month will be provided. the investigators will assess baseline characteristics and then divide patients randomly into two arms based on their date of birth (even/odd days of the month). arm a will be given metoprolol 50 mg daily for three months, after this period the effect will be evaluated and metoprolol discontinued. a month-long washout period will follow and after an additional three months without metoprolol medication, patients will be reevaluated. arm b will be without metoprolol for three months and will be evaluated thereafter. then the patients will be given metoprolol 50 mg daily for three months followed by a reevaluation. the investigators will evaluate the effect of metoprolol by multiple methods at the end of the 5th and 9th months of the trial. quality of life will be assessed by a questionnaire (the kansas city cardiomyopathy questionnaire), exercise tolerance by a spiroergometry (vo2 max). a conventional echocardiographic examination and an examination focused on exercise-induced left ventricular outflow tract obstruction will be performed. the investigators will also measure ntprobnp from a blood sample as a laboratory marker of heart failure and high sensitive troponin as a marker of myocardial injury.

Eligibility criteria:
inclusion criteria: * patients post alcohol septal ablation * pressure gradient in left ventricular outflow tract \<30 mmhg * written consent to participate exclusion criteria: * history of atrial fibrillation * symptoms of class iii or iv of new york heart association functional classification * permanent pacemaker implant * age above 75

Keywords: exercise tolerance ntprobnp left ventricular outflow tract obstruction quality of life diastolic dysfunction
attention training trial

Conditions: Chronic Pain

Summary: this study aims to examine the effects of smartphone-based attention-bias modification training (abmt) in chronic pain participants.


Eligibility criteria:
inclusion criteria: * existing chronic pain condition exclusion criteria: * none
comparison of a single rtx-grt7039 and placebo intra-articular injection for pain associated with osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: a double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of single injection of rtx-grt7039 versus placebo in patients who have pain associated with osteoarthritis of the knee despite standard of care.

this trial comprises a total observation period of up to 52 weeks.

Eligibility criteria:
inclusion criteria: * the participant has given written informed consent to participate. * the participant is 18 years of age or older at the screening visit. * the participant has a diagnosis of osteoarthritis of the knee based on american college of rheumatology criteria and functional capacity class of i to iii. * there is a documented history indicating that participant has insufficient pain relief with previous standard of care. exclusion criteria: * the participant has past joint replacement surgery of the index knee. * the participant has a history of significant trauma or surgery (e.g., open or arthroscopic) to the index knee within 12 months of screening. * the participant has periarticular pain from any cause other than osteoarthritis, including referred pain, bursitis, or tendonitis. * the participant has clinical hip osteoarthritis on the side of the index knee. * the participant has pre-existing osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, severe bone on bone osteoarthritis, knee pain attributable to disease other than osteoarthritis, or the participant has rapidly progressing osteoarthritis (rpoa) type i or type ii. * the participant has significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus \>10, valgus \>10) by x-ray as assessed by independent central readers at screening visit. * the participant has other conditions that could affect trial endpoint assessments of the index knee. * the participant has current clinically significant disease(s) or condition(s) that may affect efficacy or safety assessments, or any other reason which, in the investigator's opinion, may preclude the participant's participation in the full duration of the trial. * the participant has a history of hypersensitivity to resiniferatoxin (rtx) or any similar component (capsaicin, chili peppers). * the participant is currently participating or was participating in another investigational drug trial within 3 months prior to the screening visit. * the participant is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site or is a family member of the employees or the investigator.

Keywords: knee osteoarthritis pain assessment
visual performance measures in a virtual reality environment for assessing clinical trial outcomes in those with severely reduced vision

Conditions: Low Vision; Retinitis Pigmentosa; Stargardt Disease 1; Stargardt Disease 3; Stargardt Disease 4; Albinism

Summary: purpose: to validate a newly developed battery of performance-based tests of visual function to be presented using virtual reality. the tests are intended as potential outcome measures for clinical trials of treatments of eye disease: they measure visual performance in patients with low vision on visual tasks that a relevant for daily life.

aims of the research project: 1. to validate a new virtual reality (vr)-based battery of performance-based tests of visual function that are relevant for patients' daily lives. 2. to quantify the reproducibility of the performance-based tests. 3. to gather acceptability and ease-of-use data from patients.

Eligibility criteria:
inclusion criteria: 1. male and female participants 2. age 20-50 3. bilateral sight impairment due to stargardt's disease, retinitis pigmentosa or albinism. 4. sight impairment criteria are as follows: * visual acuity of 3 / 60 to 6 / 60 with a full field of vision. * visual acuity of up to 6 / 24 with a moderate reduction of field of vision exclusion criteria: 1. any physical impairment that would make use of the virtual reality headset difficult or unsafe. 2. a history of vertigo or dizziness.

Keywords: virtual reality quality of life
developing an intervention to address suicide risk during substance use disorder

Conditions: Suicide; Substance-Related Disorders

Summary: this is a 2-year study designed to: (1) adapt and refine an existing cognitive-behavioral treatment (cbt) intervention to decrease suicidal thoughts and behaviors for use in substance use disorder (sud) treatment settings, and (2) conduct a pilot randomized controlled trial with 50 patients in treatment for suds comparing the cbt intervention to an enhanced control condition. through this pilot randomized controlled trial, the investigators hope to not only obtain information about the feasibility of implementing these procedures in residential sud treatment, but to also determine whether this intervention decreases the level of suicidal ideation, suicide attempts, hopelessness, and frequency of substance use relative to the control condition.

existing research indicates that problematic alcohol and drug use are closely linked to both fatal and non-fatal suicide attempts. given the strong association between substance use and suicide, an episode of substance use disorder (sud) treatment provides a unique opportunity to decrease the likelihood of suicidal behaviors. however, there are no data on the effectiveness of specific interventions designed to decrease suicidal thoughts and behaviors during an episode of sud treatment in individuals at high risk for suicide. patients for this trial will be screened at the sud treatment site for a combination of a past suicide attempt and current suicidal ideation and will be randomized to cbt or control conditions. all participants in the pilot randomized controlled trial will be assessed at baseline, at the end of treatment, and at a 3-month follow-up. from a public health perspective, sud treatment programs contain large numbers of patients at high risk for future suicidal behaviors and therefore have the potential to play a central role in our nation's efforts to decrease suicide.

Eligibility criteria:
inclusion criteria: * must be over 18 years of age * report a past lifetime suicide attempt * report current suicidal ideation * resided in treatment for less than 4 weeks * in treatment for less than 6 months exclusion criteria: * mental incompetence (e.g. unable to provide informed consent) * diagnosis of schizophrenia or currently psychotic

Keywords: cognitive behavioral therapy
bone quality lyon orleans

Conditions: Osteopenic Women

Summary: qualyor is a prospective study on the predictive value for fragility fracture of various new techniques assessing bone quality, among postmenopausal women with low bone mass.


Eligibility criteria:
inclusion criteria: * 50 or older women * post-menopausal since at least one year * with osteopenia (t-score between -1.0 and -2.5 (with clinical factor risk) or -3.0 (without clinical factor risk) exclusion criteria: * corticosteroid therapy \> 3 months, at least 7.5mg/day equivalent prednisolon (stopped since at least 1 year) * osteoporosis treatment antecedent * fragility fracture antecedent * on going post-menopausal hormonal treatment * clinical signs of hepatic, cardiac or respiratory insufficiency, diseases possibly affecting bone metabolism * life expectancy \< 4 years, mental or serious illness

Keywords: osteoporosis fracture bone microarchitecture
national network genomic medicine lung cancer, germany

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: registry of the national network genomic medicine lung cancer (nngm), linking data on molecular diagnostics, clinical characteristics, treatment patterns and outcomes of subjects with non-small cell lung cancer (nsclc) from 23 specialized cancer centres and more than 400 general hospitals and oncological practices in germany

within the national network genomic medicine lung cancer (nngm), comprehensive molecular diagnostics and treatment recommendations are provided by 23 certified cancer centres according to standardized procedures for patients with non-resectable nsclc. more than 400 network partners across germany (including hospitals and oncological practices) report data on subsequent treatment and outcomes to the nngm registry. clinical outcomes are continuously evaluated through analysis of data collected in a decentralized registry. the nngm registry records the patient journey and course of the disease from first histologically confirmed diagnosis to death or loss to follow-up and comprises detailed data on demographic and clinical characteristics, molecular diagnostics (including comprehensive biomarker testing results), treatments (targeted therapy, immunotherapy, chemotherapy, radiotherapy, best supportive care) and outcomes (overall survival, response, disease progression, time to next treatment). patients have been actively involved throughout all stages of the design and running of the network and its registry.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * histologically confirmed, locally advanced or metastatic nsclc (union for international cancer control \[uicc\] stage iiib/iv; non-resectable nsclc) * from 07/2023: histologically confirmed nsclc stage ib, ii, iii (uicc) exclusion criteria: * missing written informed consent

Keywords: carcinoma, non-small-cell lung* / diagnosis carcinoma, non-small-cell lung* / genetics precision medicine lung neoplasms neoplasms by site registry pathology, molecular
the vienna prograf and endothelial progenitor cell extension study

Conditions: Immunosuppression; Renal Failure

Summary: conversion of renal transplant recipients from either tacrolimus or cyclosporin a to tacrolimus modified release to investigate the effects of the mdr1/cyp450 genotype on the trough blood levels of tacrolimus with modified galenic (tacrolimus mr4; advagraf®).

the study concerns the conversion of immunosuppressive agents among participants in the clinical trial "the vienna prograf and endothelial progenitor cell study - the vienna pep study" at the end of the study after 2 years in the extension study pep-x. the aim of the conversion is to investigate the effects of the multi-drug resistance (mdr1, gene symbol abcb1) genotype on the trough blood levels of tacrolimus modified release (tac mr4; advagraf®). analyzes of the effects of the genotype on the concentration/dose ratio (\[ng/ml\]/\[mg/d\]) will be carried out, as well as studies on existing polymorphisms in the mdr1 gene. the written informed consent to conversion of either tacrolimus (tac; prograf®) or cyclosporin a (csa; sandimmun neoral®) to tac mr4 will be obtained. upon completion of 24 months of study participation of the pep-study, and consent to convert the immunosuppressant therapy of either tac or csa to tac mr4, it will be used as indicated by the manufacturer. in patients treated with csa, the initial dose will be 0.1-0.12 mg tac mr4 per kg of body weight per day with oral morning administration. in patients who are already treated with tac, the conversion to tac mr4 will be performed in a 1:1 ratio. the dosage data for the conversion of csa to tac mr4 are taken from the documents of the european medicines agency homepage (http://www.emea.europa.eu/index/ indexh1.htm, retrieved 26.09.2007), those on the safety and equivalence of the achieved areas under the curve (auc) of both tac formulations from alloway et al. (transplant proc 2005; 37: 867-870). the conversion will be performed by univ. prof. dr. gere sunder-plassmann, and dr. markus riegersperger, respectively, both division of nephrology and dialysis, department of medicine iii, medical university of vienna, währinger gürtel 18-20, 1090 vienna. the desired trough level is set at 4.0-8.0ng/ml according to the usual clinical standards for long-term transplant patients at the investigators center. the trough level analyses are performed at the medical university of vienna, according to the following schedule: 1 week after conversion, 2 weeks after conversion, 4 weeks after conversion, 12 weeks and 12 months after conversion.

Eligibility criteria:
inclusion criteria: * any stable long-term kidney transplant recipient who participated in the vienna prograf and endothelial-progenitor study (vienna pep study; eudract identifier 2004-82 004209-98) * written informed consent to have the immunosuppression converted from either cyclosporin a or tacrolimus to tacrolimus modified-release exclusion criteria: * graft failure * contraindication to receive immunosuppression

Keywords: calcineurin inhibitors tacrolimus modified release conversion trough levels mdr-1
natural history-hepatitis c virus/ human immunodeficiency virus coinfection

Conditions: Hepatitis C; HIV; Anemia

Summary: the purpose of this study was to describe the time course and extent of hemoglobin (hb) changes and the erythropoietic response to peg-ifn/rbv (pegylated interferon and ribavirin)-induced anemia in hcv(hepatitis c virus)/hiv (human immunodeficiency virus) co-infected subjects.

patients receiving combination therapy for chronic hepatitis c virus (hcv) infection (standard or pegylated interferon alfa \[peg-ifn\] in combination with ribavirin \[rbv\]) frequently develop moderate to severe anemia. in large, prospective, clinical trials of peg-ifn alfa-2b and peg-ifn alfa-2a, the reported mean decreases in hemoglobin (hb) were 2.5 g/dl, and 3.7 g/dl, respectively. furthermore, in a retrospective study, 54% of standard interferon/rbv-treated patients had hemoglobin decreases of at least 3 g/dl. it is important to understand the causes, natural history, and risk factors associated with hcv therapy-induced anemia, because such decreases in hemoglobin can result in rbv dose reduction or discontinuation, which may decrease the likelihood of a virologic response by patient. erythropoietin is an endogenous hormone that acts in the bone marrow to increase the number of erythroid progenitor cells (red blood cells). normally, a decrease in the hemoglobin level is accompanied by an increase in the serum erythropoietin (sepo) level, which will ultimately normalize the hemoglobin level. the relationship between hemoglobin and serum erythropoietin is less apparent in patients with chronic diseases such as cancer and human immunodeficiency virus (hiv) infection. it is not known whether hcv/hiv co-infected patients receiving combination peg-ifn/rbv therapy have a similarly diminished erythropoietic response to anemia. the objective of this study is to document the pattern of hemoglobin changes and erythropoietic response (from baseline to final assessment) in hcv/hiv co-infected patients receiving combination therapy with ifn / rbv. n/a

Eligibility criteria:
inclusion criteria: * hiv- infected patients confirmed by hiv-rna level * hcv- infected patients confirmed by pcr(polymerase chain reaction) or branched dna (b-dna) * scheduled to commence combination ifn/rbv therapy on day 1 * normal serum creatinine * on stable antiretroviral regimen (for hiv) for at least 4 weeks * life expectancy \> 6 months exclusion criteria: * patients with history of any primary hematologic disease * anemia attributable to factors such as iron or folate deficiency, pre-treatment * hemolysis or gastrointestinal bleeding * has suspected or confirmed significant hepatic disease from an etiology other than * hcv (e.g. alcohol, hbv dna, autoimmune disease etc)

Keywords: natural history, hepatitis c infection, hiv infection, hcv/hiv co-infection ribavirin, pegylated interferon, interferon
evaluation of php-201 ophthalmic solution in patients with normal tension glaucoma

Conditions: Normal Tension Glaucoma

Summary: evaluation of the optimal dose for the efficacy in reduction of intraocular pressure and safety of php-201 ophthalmic solution in patients with normal tension glaucoma

data collection (electronic case report forms), data dictionary (meddra)

Eligibility criteria:
inclusion criteria: * 19 years and older, female and male * iop ≤21 mmhg * subject showing open angle finding, glaucomatous optic nerve damage and visual field defects * bcva ≥+0.2 exclusion criteria: * subject with the disease and surgery history that are not eligible to participate (acute closed angle glaucoma, narrow angle glaucoma, advanced glaucomatous loss, ocular trauma, eye surgery or laser surgery, unstable angina, myocardial infarction, uncontrolled hypertension and diabetes, etc) * subject who can't discontinue contact lenses * subject who can't discontinue topical/systemic iop lowering medication
study of kras neoantigen mrna vaccine (abo2102) in patients with kras -mutated solid tumors

Conditions: Pancreatic Neoplasms; Other Solid Tumors

Summary: the purpose of this study is to evaluate the safety, immunogenicity, pharmacodynamics, as well as preliminary efficacy of kras neoantigen mrna vaccine (abo2102) alone and in combination with toripalimab (anti-pd-1 monoclonal antibody) among participants with kras-mutated advanced pancreatic cancer and other solid tumors. the trial includes dose escalation (part i) and dose expansion(part ii) parts.


Eligibility criteria:
inclusion criteria: 1. ≥18 years of age at time of informed consent. 2. participants with histologically and/ or cytologically confirmed advanced solid tumors (such as pancreatic ductal adenocarcinoma, non-small cell lung cancer, etc.), whose disease has progressed or being intolerant to relevant treatments during or following at least one line of systemic treatment; patients in the second stage include those who have experienced disease progression or intolerance to previous systemic treatments, as well as those who have not received systemic therapy but are deemed by the investigator to potentially benefit from the study treatment based on a comprehensive clinical assessment. 3. harboring at least one of the targeted kras mutants. 4. eastern cooperative oncology group (ecog) performance status score of 0\~2. 5. life expectancy of ≥12 weeks. 6. sufficient organ function. exclusion criteria: 1. any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that have been cured, superficial bladder cancer, or carcinoma in situ of the breast or cervix. 2. received kras cancer vaccine before. 3. immunosuppressants or other immunomodulatory drugs were required within 4 weeks before the first dose of study treatment. physiological doses of systemic steroids or topical medications are allowed. topical medications should not exceed the dose recommended in the package insert or have any systemic exposure signs; or patients with other acquired or congenital immunodeficiency diseases, or a history of organ transplantation who need to use immunosuppressants or other immunomodulatory drugs. 4. history of severe allergies or known allergies to any active or inactive component of the study drug(s). 5. uncontrolled systemic infection; active tuberculosis. 6. severe cardiovascular diseases. 7. has known symptomatic, untreated central nervous system metastases, or cns metastases requiring continued treatment. participants with asymptomatic brain metastases and who do not require treatment are eligible for enrolment. 8. have active autoimmune and inflammatory diseases. 9. have immediate hypersensitivity, a history of eczema or asthma uncontrolled by topical corticosteroids. 10. have other serious medical conditions 11. a history of organ transplantation, bone marrow transplantation or hematopoietic stem cell transplantation.
persistent pain after breast cancer treatment (ppbct) - risk factors and pathophysiological mechanisms

Conditions: Breast Cancer; Persistent Pain; Lymphedema; Neuropathic Pain; Neuropathy

Summary: the study is a prospective cohort study following breast cancer patients from before surgery to one year after. the aims of the study are to determine risk factors that predispose to the development of persistent pain.

the aim of the study is 1) to determine pre-, intra and post surgical risk factors for persistent pain after breast cancer treatment 2) to examine the prevalence of persistent pain 6 and 12 months after surgery 3) provide a quantitative sensory testing (qst) profile of the patient population, measured pre surgery, 1 week and 12 months after surgery.

Eligibility criteria:
inclusion criteria: * diagnosed with breast cancer * 18 years or older exclusion criteria: * unable to give written consent * unable to understand danish * previous cosmetic surgery in the breast * previous surgery in ipsilateral breast * bilateral cancer * concomitant corrective surgery on contralateral side * pregnant * other disease or injury in the nervous system * psychiatric disease * alcohol or drug abuse