Kornimate/medical-research-clean huggingface dataset:
evaluation of self-mediated alternatives for risk testing education and return of results

Conditions: Alzheimer Disease

Summary: this randomized non-inferiority study will evaluate self-directed scalable electronic health platform (ehealth) methods for communicating alzheimer's gene and biomarker results compared to videoconference telehealth disclosure with healthcare providers, as well as characterize the impacts of learning this information on the participant.

this is a randomized trial to evaluate self-directed scalable ehealth methods for communicating alzheimer's gene and biomarker results, as well as characterize the clinical impacts of learning this information on the participant. all participants in the study will be randomized to receive their alzheimer's gene and biomarker results either via person-mediated telehealth videoconference visit with a healthcare provider or by ehealth platform. a permuted block design will be used for randomization, and we will stratify by sex and apolipoprotein e (apoe) genotype. participants randomized to the ehealth arm will be offered either the adwebportal or adchatbot but can switch between platforms or schedule a virtual appointment to speak with a healthcare provider at any point. use of the pre-disclosure education platforms will be tracked. a hipaa compliant telehealth application will be used for the person-mediated telehealth videoconference visits and sessions will be recorded. potential participants will be identified from the genematch program. study management and participation will be decentralized. confirmation of eligibility and consent of potential participants will be completed remotely by a decentralized study team. procedures requiring physical attendance (e.g., blood draw) will be completed remotely using mobile health services.

Eligibility criteria:
inclusion criteria: * access to the internet and an internet-enabled device. * participant is able to provide informed consent as shown by correctly answering questions administered by the study coordinator during the electronic consenting process that assess understanding of consent form content. * participant is willing and has the ability to fully comply with study procedures defined in this protocol. * written and spoken fluency in the english. * participant agrees to undergo a blood draw for collection of a blood sample for future testing and repository storage. exclusion criteria: * participant reports prior knowledge of apoe genotype. * lack of psychological readiness to receive ad gene and biomarker information as indicated by: 1. obtaining a score of 10 or greater on the patient health questionnaire - 9 (phq-9) and/or 2. responding yes on any of the suicidal ideation questions extracted from the abbreviated columbia suicide severity scale (c-ssrs) or ad specific suicidality questions. * presence of current major psychiatric illness, e.g., psychosis, bipolar disorder, ptsd * communication difficulties such as: 1. uncorrected or uncompensated hearing and/or vision impairment. 2. uncorrected or uncompensated speech defects.

Keywords: apoe
a study of pirtobrutinib (ly3527727 [loxo-305]) versus placebo in participants with relapsing multiple sclerosis

Conditions: Relapsing Multiple Sclerosis; Multiple Sclerosis

Summary: the main purpose of this study is to assess efficacy and safety of pirtobrutinib in participants with relapsing multiple sclerosis.


Eligibility criteria:
inclusion criteria: * participants must have been diagnosed with relapsing ms * participants must have one of the following 1. at least 1 documented relapse within the previous year, or 2. at least 2 documented relapse within the previous 2 years, or 3. at least 1 active gd-enhancing brain lesion on an mri scan in the past 6 months prior to screening. exclusion criteria: * have had a diagnosis of primary progressive ms * have a history of another clinically significant neurological disease * had a relapse of ms within 30 days prior to randomization.

Keywords: relapsing forms multiple sclerosis
early preparation with gonadotropin- releasing hormon (gnrh) agonists injection with frozen-thawed embryo transfer?

Conditions: Infertility, Female

Summary: the study intended to include \>200 infertile women with impaired ovulation who will be subjected to hrt at d-21 of previous menstrual cycle (group a) or d-1 of menses of replacement cycle (group b). all patients received the same luteal support in the form of intravaginal progesterone two day before embryos transfer until blood pregnancy test was performed 14 days later. clinical pregnancy was diagnosed by measurement of β-human chorionic gonadotropin level and was confirmed 2-weeks later by tvu.

the study intended to include \>200 infertile women with impaired ovulation who will be subjected to hrt at d-21 of previous menstrual cycle (group a) or d-1 of menses of replacement cycle (group b). all patients received the same luteal support in the form of intravaginal progesterone two day before embryos transfer until blood pregnancy test was performed 14 days later. the classic testart slow freezing and rapid thawing protocol was applied on stage-2 pronuclear embryos. endometrial thickness was measured in the midsagittal plane using transvaginal ultrasound (tvu). clinical pregnancy was diagnosed by measurement of β-human chorionic gonadotropin level and was confirmed 2-weeks later by tvu.

Eligibility criteria:
inclusion criteria:infertile women with impaired ovulation - exclusion criteria: -
evaluation of a web-based virtual nursing epilepsy self-management intervention

Conditions: Epilepsy

Summary: the purpose of this pilot randomized controlled trial is to evaluate a web-based virtual nursing intervention (épi-tavie) in terms of 1) acceptability and feasibility, and; 2) preliminary efficacy.


Eligibility criteria:
inclusion criteria: * to be a patient of the clinique d'épilepsie du centre hospitalier de l'université de montréal * to be able to read and understand french * to have access to the internet exclusion criteria: * having an uncontrolled psychiatric or cognitive condition

Keywords: web-based intervention self-management nursing epilepsy seizures
endovascular interventions with angiomax: the endomax trial

Conditions: Peripheral Endovascular Interventions; Bleeding

Summary: the primary objective of the study is to test whether anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (ufh) in participants undergoing peripheral endovascular interventions (pei). the secondary objective is to test whether there were potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction (mi), stroke and/or transient ischemic attack (tia), amputation, unplanned repeat revascularization (urv), and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes.


Eligibility criteria:
inclusion criteria: * participants ≥ 18 years of age * must be undergoing one of the following pei procedures: * carotid artery stenting * lower extremity interventions (lei) for critical limb ischemia * lei for claudication * provide written informed consent prior to any study-specific procedure being performed exclusion criteria: * any known contra-indication to the use of bivalirudin or ufh * acute limb ischemia * planned amputation regardless of the outcome of the pei * dialysis dependent * weight less than 38 kg or more than 202 kg * history of any bleeding diathesis or severe hematological disease * history of intra-cranial: mass, aneurysm, arteriovenous malformation or hemorrhage * gastrointestinal or genitourinary bleeding within the 30 days prior to randomization * any surgery (excluding punch or shave skin biopsy) within the 30 days prior to randomization * concomitant percutaneous coronary intervention * any percutaneous coronary, endovascular, or structural heart disease procedure within 30 days prior to randomization * international normalized ratio \>1.7 within 24 h prior to the index procedure * administration of therapeutic doses of ufh within 30 min prior to the index procedure (a low dose \[≤2000 u\] of heparin is permitted during the diagnostic angiogram prior to the intervention) * administration of enoxaparin within 8 h; other low molecular weight heparins or fondaparinux within 24 h; any oral anti-xa or antithrombin agent within 48 h; or thrombolytics, glycoprotein inhibitors, or warfarin within 72 h prior to the index procedure * severe contrast allergy that cannot be pre-medicated * procedures performed by radial access when they are intended as the primary access site for the index procedure * known or suspected pregnant women or nursing mothers * previous enrollment in this study (mdco-biv-12-03) * participation in other investigational drug or device trials within 30 days prior to randomization * participants who, for any reason, are deemed by the investigator to be inappropriate for this study
a two-arm study comparing the analgesic efficacy and safety of acetaminophen and tramadol combination bid versus placebo for the treatment of acute low back pain

Conditions: Acute Low Back Pain

Summary: a multi-center placebo controlled, double-blind, trial comparing the analgesic efficacy and safety of acetram contramid® bid versus placebo for the treatment of acute low back pain in patients between 18 and 80 yrs of age.


Eligibility criteria:
inclusion criteria: * males or females in generally good health aged 18-80 years with moderate to severe acute low back pain. * current acute low back pain episode within 48h prior to study entry. * pain must be moderate to severe following incident exclusion criteria: * chronic low back pain * ongoing or history of alcohol or drug abuse * body mass index greater 39 * treatment within the last 3 weeks with monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds; neuroleptics; selective serotonin reuptake inhibitors * known history or symptoms suspicious for cancer * significant renal or liver disease * spinal surgery within 1 year of study entry. * subjects who are pregnant or lactating. * subjects with unstable medical disease. * subjects who have received treatment with an investigational product/device with 30 days prior to study entry.
cardiogenic shock working group registry

Conditions: Cardiogenic Shock

Summary: the cardiogenic shock working group is a multicenter registry where we collect de-identified clinical variables from the medical records and follow-up phone calls of shock patients from multiple institutions and centralize this data to a single registry for analysis of clinical outcomes.

the cardiogenic shock working group is an academic research consortium involving multiple medical centers within the united states and includes a multicenter registry for patients with cardiogenic shock. de-identified clinical variables are collected from medical records and follow-up phone calls. there is currently no central database for cardiogenic shock, therefore analysis of cardiogenic shock on a larger scale is limited. a goal of the cardiogenic shock working group is to create a centralized registry, compiled of data from multiple institutions, to analyze clinical outcomes. the cardiogenic shock working group registry will include a retrospective arm, where data is collected during the course of the hospital stay, and a prospective arm, where long-term outcomes will be assessed.

Eligibility criteria:
inclusion criteria: * patients must have cardiogenic shock. cardiogenic shock is defined by at least one of the two categories below: 1. at least 2 of the following concurrently at any point during the index hospitalization: * cardiac index \< 2.2 * papi \< 1.0 * cardiac power output ≤ 0.6 * map \ 30mmhg drop in map from baseline * sbp \ 30mmhg drop in sbp from baseline * pulse \> 100 2. require at least one acute mechanical circulatory support device, vasopressor or inotrope to maintain values above the above target. post-cardiotomy patients must meet the inclusion criteria 72 hours after their surgery to be included in this registry.

Keywords: cardiogenic shock mechanical circulatory support hemodynamics heart failure acute myocardial infarction registry critical care clinical outcomes research
pegaferon and ribavirin for hepatitis c

Conditions: Hepatitis C

Summary: the purpose of this study is to evaluate the safety and efficacy of a locally produced 40kd pegylated interferon alpha-2a (pegaferon) in patients with hepatitis c. 100 patients will be treated using standard guidelines for hepatitis c. response to treatment and side effects will be recorded.

the product is locally produced and needs to be evaluated in terms of efficacy and safety.

Eligibility criteria:
inclusion criteria: * chronic hepatitis c * age between 15 and 65 exclusion criteria: * previous treatment for chronic hepatitis c * co-infection with human immunodeficiency virus or hepatitis b virus * major thalassemia or hemophilia * active drug user * being treated for major depression or psychosis * decompensated cirrhosis * serum creatinine \> 1.5 mg/dl * solid organ transplant * untreated thyroid disease * uncontrolled diabetes mellitus * uncontrolled autoimmune disease * advanced cardiac or pulmonary disease. * planning to become pregnant in the next 1.5 years * patients with inadequate contraception * not consenting to the study

Keywords: hepatitis c
study for validation of standardized questionnaires on depression and investigation of the frequency of depression in rheumatoid arthritis (ra) participants

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to validate standardized questionnaires on depression for ra and to investigate the frequency of depression with ra. the study will include 2 parts, vadera i and vadera ii. in vadera i, 300 participants will be surveyed twice at an interval of 3 months regarding their current emotional condition using standardized questionnaires. on the basis of the results of vadera i, in vadera ii, the selected questionnaire will be used to assess the prevalence of depression with ra in approximately 1000 participants.

vadera i is regarded as interventional epidemiologic study. the study was considered as interventional because of the use of the questionnaires and interview for the diagnosis of depression. vadera ii is a cross-sectional epidemiologic study.

Eligibility criteria:
inclusion criteria: * vadera i: participants diagnosed with ra, who did not suffer from a concurrent, manifest depressive disorder and had been scheduled for a ra consultation at one of the participating clinics * vadera ii: all participants diagnosed with ra who were able to complete the questionnaires and had been scheduled for a ra consultation at one of the participating clinics
evaluation of crestor® (rosuvastatin) in daily practice

Conditions: Hypercholesterolemia

Summary: this open label, non-interventional study is to show the efficacy of crestor (rosuvastatin) in reduction of ldl-cholesterol and cardiovascular risk parameters in patients with hypercholesterolemia. effectiveness is to be evaluated using the difference in ldl cholesterol level between the first and the second visit after 12 weeks.


Eligibility criteria:
inclusion criteria: * a patient with hypercholesterolemia who has been prescribed crestoraccording to physician's judgement, irrespective of the inclusion in the study. * no treatment with any statin in the last 3 months exclusion criteria: * hypersensitivity to rosuvastatin or any other ingredient of crestor * active liver disease, severe renal insufficiency * myopathy or predisposing risk factors for myopathy/ rhabdomyolysis * woman of child-bearing potential and not using appropriate contraceptive measures, pregnancy or lactation

Keywords: hypercholesterolemia cholesterol ldl-cholesterol rosuvastatin crestor
prevalence of bk viremia in simultaneous liver-kidney transplant

Conditions: Polyomavirus Infections; BK Viremia; Liver Transplant Infection; Kidney Transplant Infection

Summary: the human bk polyomavirus is a significant risk factor for renal transplant dysfunction and allograft loss. the prevalence of bk viremia (bkv) following kidney transplantation is estimated to be 10-20%.

the human bk polyomavirus is a significant risk factor for renal transplant dysfunction and allograft loss. the prevalence of bk viremia (bkv) following kidney transplantation is estimated to be 10-20%. immunosuppression reduction is the management cornerstone for bkv and has been shown to be effective at clearing the virus while maintaining graft function in both kidney alone and simultaneous kidney-pancreas transplant recipients. however, there is a lack of published data on the prevalence and outcomes in simultaneous liver-kidney (slk) transplant recipients.

Eligibility criteria:
inclusion criteria: * age 18 years or older * slk recipients transplanted at mdmc between 2015-2020 exclusion criteria: * below 18 years of age * patients who did not undergo slk transplant at mdmc
hairy cell leukemia patient data registry

Conditions: Leukemia, Other

Summary: the overall objective is to develop a clinical data registry that can be used to facilitate research with the ultimate goal of reducing the morbidity and/or mortality and improving the quality of life of patients diagnosed or living with hairy cell leukemia. with approximately 1,000 new cases of this rare disease identified in the us each year, hcl represents 2% of all cases of leukemia in adults. considering the rarity of this chronic leukemia, the hairy cell leukemia foundation (hclf), in partnership with investigators from its centers of excellence, seeks to develop a registry to help researchers identify new trends in outcomes, recognize the most effective treatments, discover previously unknown complications of the disease, and design clinical trials for new therapies.

this clinical registry is being established to collect de-identified information on this rare disease. the registry created by assimilation of de- identified coded patient data will centralize information that can be used to improve the management of the many complications of this disease and its treatment. this study is focused on collection of clinically and biologically meaningful endpoints across multiple institutions; as such, it is not focused on a specific set of hypotheses but will collect data that will facilitate such analyses. the investigators will collect information related to the symptoms and the clinical course of the disease, to the complications from the disease and its treatment, presence of minimal residual disease, frequency of relapse and subsequent management, data on novel molecular markers associated with the prognosis. in conjunction with the department of bioinformatics at the ohio state university, the investigators have created a system for safeguarding the confidentiality and the identity of all patients who agree to participate in this research registry. each participating institution will be responsible for de-identification of the data, using software developed by the ohio state university, department of biomedical informatics, before it is used in the registry. each institution will confidentially maintain a code for linking this information to an individual patient. each participating institution will have direct control over the data contained in the registry that is associated with their respective patient population. as a result of these measures, should a patient wish to withdraw from the registry, the responsible institution will be able to immediately remove all records related to that patient from the registry.

Eligibility criteria:
inclusion: * patients with classic hairy cell leukemia * patients with the variant of hairy cell leukemia. exclusion: * children are excluded from the study, since hairy cell leukemia wasn't described in children.

Keywords: hairy cell
implementation of problem management plus (pm+) in adult syrian refugees in turkey: pilot

Conditions: Anxiety; Depression; Posttraumatic Stress Disorder

Summary: to implement problem management plus (pm+) in syrian refugees with this pilot study in turkey with the aim of informing the definitive rct about drop-out rates and estimated effect sizes.

the strengths (syrian refugees mental health care systems) study is a 5-year study that started in january 2017 with funding from the european commission horizon 2020 scheme and turkey is one of the sites that this study will be conducted. the main aim of strengths in turkey is to evaluate the feasibility, acceptability, effectiveness and cost-effectiveness of the culturally adapted psychological intervention problem management plus (pm+) intervention for adult syrian refugees in turkey. the current trial registration is for the pilot trial to investigate the feasibility and acceptability (e.g., obtain estimates of drop-out rates), to inform a full-scale, definitive randomized controlled trial. study participants (n=60) will consist of adult syrian refugees (18 years and older) in turkey with self-reported functional impairment (whodas 2.0 \>16) and elevated psychological distress (k10 \>15.9). participants will be randomly allocated either to the treatment group who will receive five sessions of pm+ or to the enhanced care-as-usual (e-cau) group. participants in the comparison group will receive e-cau only. the primary outcome will be the decrease in psychological distress from baseline to three-month post-intervention assessment, measured through the hopkins symptoms checklist (hscl-25).

Eligibility criteria:
inclusion criteria: * adults of 18 years or above * syrian under temporary protection status * arabic-speaking * elevated levels of psychological distress (k10 \>15.9) and reduced psychosocial functioning (whodas 2.0 \>16) exclusion criteria: * acute medical conditions * imminent suicide risk or expressed acute needs/protection risks (e.g., a young woman who expresses that she is at acute risk of being assaulted or killed) * severe mental disorder (psychotic disorders, substance-dependence) * severe cognitive impairment (e.g., severe intellectual disability or dementia)

Keywords: refugees mental health problems
lus at birth in infants born before 26 weeks

Conditions: Extremely Low Birth Weight Infants; Respiratory Distress Syndrome, Newborn

Summary: all infants born before 26 weeks born in a hospital included in the registry will receive a lu at birth, before the first dose of surfactant. we will register as well the length of imv, niv or the need of imv in the whole sample.


Eligibility criteria:
inclusion criteria: * infants born before 26 weeks at any of the participant hospitals. exclusion criteria: * received surfactant before lu * redirection of care * severe malformations of cromosomopathies * unable to perform lu

Keywords: lung ultrasound premature infant extremely low birth weight infants