Kornimate/medical-research-clean huggingface dataset:
a phase 1 study evaluating amg 232 in advanced solid tumors or multiple myeloma

Conditions: Advanced Malignancy; Advanced Solid Tumors; Cancer; Oncology; Oncology Patients; Tumors; Glioblastoma; Multiple Myeloma

Summary: first in human, open-label, sequential dose escalation and expansion study of amg 232 in subjects with advanced solid tumors or multiple myeloma

study design: this is an open-label, dose exploration study evaluating amg 232 in subjects with advanced p53wt solid tumors or multiple myeloma. the study will be conducted in 2 parts: part 1 - dose exploration (parts 1a, 1b and 1c) and part 2 - dose expansion. part 1a is aimed at evaluating the safety, tolerability, pk and pd of amg 232 and determining the mtd of a 7-day once daily (qd) dosing schedule in subjects with advanced solid tumors using a practical continuous reassessment method (crm). part 1b will evaluate the safety and tolerability of 3-day qd dosing schedule (or alternate dosing schedule based upon emerging data) with a particular emphasis on evaluating the tolerability of daily doses equal to or higher than the part 1a mtd in subjects with solid tumors or multiple myeloma. part 1c will evaluate the safety and tolerability of 7-day twice daily (bid) dosing schedule with daily cumulative doses equal to or higher than the part 1a mtd in subjects with solid tumors. the dose expansion part of the study (part 2) can open once the mtd has been determined in part 1a. part 2, part 1b and part 1c can be explored in parallel. the dose expansion part will consist of up to 85 additional subjects with specific tumors harboring mdm2 amplification (liposarcoma \[lps\], gliobastoma \[ gbm \] and all other solid tumors) or potentially harboring mdm2 overexpression (er+ metastatic breast cancer) and a group of subjects with multiple myeloma.

Eligibility criteria:
inclusion criteria: * men or women \> 18 years old * pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, or which no standard therapy is available, or the subject refuses standard therapy or multiple myeloma * willing to undergo pre-dose core needle tumor biopsies or bone marrow aspirate for subjects with multiple myeloma. * ability to take oral medications and willing to record daily adherance to investigational product * adequate hematological, renal, hepatic, and coagulation laboratory assessments exclusion criteria: * active brain metastases * for solid tumor-history or presence of hematological malignancies unless curatively treated with no evidence of disease for greater than or equal to 5 years * active infection requiring intravenous (iv) antibiotics * anti-tumor therapy * therapeutic or palliative radiation therapy within 30 days of starting treatment * currently enrolled in another investigational device or drug study

Keywords: solid tumors multiple myeloma
sperm preparation prior to intrauterine insemination study

Conditions: Infertility; Infertility Secondary; Infertility Unexplained; Anovulation; Fertility Disorders; Reproductive Issues

Summary: this is a randomized controlled trial comparing density gradient centrifugation and microfluidic sperm sorting in patients undergoing intrauterine insemination to evaluate cumulative pregnancy outcomes.

study participants will be randomized to either standard sperm preparation (density gradient centrifugation) versus sperm preparation with the zymot multi sperm preparation device for their three month intrauterine insemination treatment course. patients will follow standard treatment plans designed by their fertility physician and will be followed until referred for prenatal care at 8-10 weeks of pregnancy to determine pregnancy outcomes.

Eligibility criteria:
inclusion criteria: * patients undergoing intrauterine insemination * patient assigned female at birth with age \<41 exclusion criteria: * any significant disease or psychiatric disorder that would interfere with the consenting process * prior intrauterine insemination * use of frozen donor sperm * non-english speaker

Keywords: intrauterine insemination insemination fertility infertility
comparative analysis of phase lag entropy (ple) and bispectral index (bis) as an anesthetic depth indicator

Conditions: General Anesthesia

Summary: the aim of this comparative analysis is to evaluate the reliability of ple value as an anesthetic depth indicator

1. to evaluate the reliability of ple value as an anesthetic depth indicator, the investigators compare ple value with bis score during induction and emergence of general anesthesia using propofol target controlled infusion. 2. in addition, the investigators verify whether or not the facial nerve integrity monitoring affects the efficacy for ple and bis values as an anesthetic depth indicator.

Eligibility criteria:
inclusion criteria: * patients who scheduled for otopharyngeal surgery under facial nerve integrity monitoring requiring general anesthesia and american society of anesthesiology (asa) physical status 1 or 2 exclusion criteria: * patient who has been taken anticonvulsant agents, sedatives, and hypnotics * patient who has central nerve system disease, neurological disorder * patient with hypersensitivity to anesthetics
testing a lifestyle physical activity intervention for women with depression in alcohol treatment

Conditions: Alcohol Use Disorder; Depression

Summary: the primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity (lpa) intervention for preventing relapse among women with depression engaged in alcohol treatment. participants are randomized to either 1) lpa+fitbit intervention or 2) fitbit only control condition. follow-up assessments and ema data will be collected.

alcohol use disorder (aud) is a significant and costly public health problem that affects one-third of the u.s. population in their lifetime. women develop aud more quickly and suffer a broader range of adverse alcohol-related health consequences than men. physical activity (pa) interventions may play an important role as an alternate coping strategy for women with aud and a means to decrease relapse. the primary aim of this project is to test the efficacy of a technology-supported lifestyle physical activity (lpa) intervention for preventing relapse among women with depression engaged in alcohol treatment. a total of 214 women from the alcohol and drug partial hospitalization program (adp) at butler hospital with aud and depression will be recruited and randomly assign them to either a: 1) lpa+fitbit intervention or 2) fitbit only control condition. follow-up assessments will occur at 6-weeks, end of treatment (eot) at 3 months, and 6, 9 and 12 months. participants will also complete 3, 10-day periods of ecological momentary assessment (ema) during early recovery, at approximately weeks 1 \& 2, 5 \& 6, and again at weeks 11 \& 12.

Eligibility criteria:
inclusion criteria: * female * between 18 and 65 years of age * score of 5 or above on the phq-9 (need to have a score of 1 on questions 1 or 2) * are sedentary/low active (i.e. less than 150 minutes/week of moderate-intensity exercise for the past 3 months) * are currently engaged in alcohol treatment * own a smartphone - to allow for ema software and fitbit application exclusion criteria: * current dsm-5 diagnosis moderate/severe substance use disorder or anorexia or bulimia nervosa * a history of psychotic disorder or current psychotic symptoms * current suicidality or homicidality * current mania * marked organic impairment according to either the medical record or responses to the diagnostic assessments * physical or medical problems that would not allow safe participation in a program of moderate intensity physical activity (i.e., not medically cleared by study physician) * current pregnancy or intent to become pregnant during the next 12 weeks
cluster-randomized trial of air filtration and ventilation to reduce covid19 spread in homes

Conditions: Covid19

Summary: investigators are evaluating whether an intervention consisting of box-fans with merv 16 filters ("filtration fans") and recommendations for improving ventilation in the home can reduce secondary spread of covid19 from an index case to susceptible contacts within the home.


Eligibility criteria:
inclusion criteria: * household members live in a shared space (apartment, home) with others (as opposed to renting single rooms in a shared space, for example) * at least 3 other people live in the household aside from index case exclusion criteria: * if index case test positive day was over 2 days prior * if half or more household members are thought to be infected already * if household has fewer than 3 contacts interested in participating in the study * if fewer than 3 contacts are expected to be present in the house for a majority of the following 7 days

Keywords: ventilation air filtration covid19 sars cov 2 household transmission
heparin like effect in acute variceal bleeding

Conditions: Coagulation Disorder; Cirrhosis, Liver; Variceal Hemorrhage

Summary: this study attempts to clarify the pathophysiology of haemostasis in relation to the evidence of sepsis in liver disease, and compares the accuracy of various available laboratory tests in assessment of these patients. further research is needed for proper understanding of the influence of sepsis on coagulation disorders in acute variceal bleeding in cirrhosis, to correctly identify the type and optimal quantity of blood product requirement in at risk patients. thromboelastography (teg) /sonoclot has been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products. secondly, the study of derangement in coagulopathy after the onset of sepsis is of paramount importance because of increased mortality after the onset of sepsis. in the present study, patients with cirrhosis who present with acute variceal bleeding, will be included in the study cohort, and will undergo a baseline diagnostic workup as described. they will be followed for development of any signs of infection after hospitalization. then the effect of sepsis on their coagulation and thrombin generation response swill be assessed. thus the effect of sepsis on the progression and outcome of coagulopathy in patients with acute variceal bleeding will be studied.


Eligibility criteria:
inclusion criteria: * age 18-65 years * cirrhosis with acute variceal bleeding. exclusion criteria: * patients with evidence of sepsis at presentation. * current therapy: recent blood or blood component transfusion in the last 2 weeks. * hiv positive/ aids patients * patients requiring antiplatelet therapy, * renal insufficiency requiring dialysis * active malignancy within the last 5 years * patient with other neurological disease and metabolic disorders, unbalanced heart failure and/or respiratory failure or end-stage renal disease * administration of anticoagulants, antifibrinolytics, * not willing to participate in the study

Keywords: thromboelastography variceal bleeding
efficacy and safety study of desmoteplase to treat acute ischemic stroke

Conditions: Stroke

Summary: the purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms.

acute stroke is a major cause of mortality and long-term disability in the developed world. the only currently approved thrombolytic intervention for acute ischemic stroke, which constitutes the majority of strokes, is alteplase (recombinant tissue plasminogen activator; rtpa). the use of alteplase is limited as it is approved for use within 3 hours after symptom onset and by the risk of inducing intracerebral haemorrhage; consequently fewer than 3% of acute stroke subjects are treated. the thrombolytic agent desmoteplase (recombinant desmodus salivary plasminogen activator alpha-1; rdspaalpha-1) produced by recombinant biotechnology has its naturally occurring counterpart in the saliva of the vampire bat desmodus rotundus. compared to alteplase, desmoteplase has a more favourable profile in terms of high fibrin specificity and non neurotoxicity. the study aims to confirm efficacy and safety of desmoteplase for thrombolytic therapy of patients with acute ischaemic stroke in the extended time window of 3-9 hours after onset of stroke symptoms.

Eligibility criteria:
inclusion criteria: * diagnosis of acute ischemic stroke * informed consent * age between 18 and 85 years * treatment can be initiated within 3-9 hours after the onset of stroke symptoms * nihss score of 4-24 * vessel occlusion or high-grade stenosis on mri or cta in proximal cerebral arteries exclusion criteria: * pre-stroke mrs \>1 * previous exposure to desmoteplase * extensive early infarction on mri or ct in any affected area * imaging evidence of ich or sah; av malformation; cerebral aneurysm; or cerebral neoplasm * internal carotid artery occlusion on the side of the stroke lesion * treatment with heparin in the past 48 hours and a prolonged partial thromboplastin time * treatment with oral anticoagulants and a prolonged prothrombin time * treatment with glycoprotein iib - iiia inhibitors within the past 72 hours. use of single agent oral platelet inhibitors is permitted * treatment with a thrombolytic agent within the past 72 hours

Keywords: acute ischemic stroke angiography desmoteplase thrombolytic
continuous versus intermittent administration of epidural analgesia during labor

Conditions: Epidural; Analgesia

Summary: prospective randomized single blind study, including full term adult parturients, asa 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups. epidural analgesia was initiated and maintained with a solution of bupivacaine 0,125% and sufentanil 0,25 mcg/ml. after an initial bolus of 16 ml, patients were randomly assigned to receive intermittent boluses of 8 ml every 60 minutes after the initial dose followed by supplementary pcea boluses of 8 ml for the first group ( pcea group) or a continuous epidural infusion at the rate of 8 ml/h adjustable and starting immediately after the initial bolus of 16 ml for patients of the second group (cei group).

prospective randomized single blind study, including full term adult parturients, asa 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups. epidural analgesia was initiated and maintained with a solution of bupivacaine 0,125% and sufentanil 0,25 mcg/ml. after an initial bolus of 16 ml, patients were randomly assigned to receive intermittent boluses of 8 ml every 60 minutes after the initial dose followed by supplementary pcea boluses of 8 ml for the first group ( pcea group) or a continuous epidural infusion at the rate of 8 ml/h adjustable and starting immediately after the initial bolus of 16 ml for patients of the second group (cei group). the main outcome of this study was: the incidence of motor blockage. our secondary outcomes were: maternal satisfaction, local anaesthetic and sufentanil cumulated doses, duration of the second stage of labor, mode of delivery and pain during labor using the visual analogic score (vas score).

Eligibility criteria:
inclusion criteria: * full term parturients scheduled for vaginal delivery exclusion criteria: * patients in whom cesarean section delivery was indicated during labor

Keywords: epidural, analgesia, labor, delivery
nationwide uniform scientific evaluation of flexible and integrated treatment projects from 2022 onwards

Conditions: Mental Health; Cross-sectoral Treatment; Flexible and Integrated Treatment; FIT; Psychiatry; Evaluation Study; Cohort Studies

Summary: this study is an evaluation of flexible and integrated psychiatric care models (according to § 64b of the german social code book v (sgb v)) (fit) including new fit projects starting after 2022 and the prolongation of any of 19 already established fit projects (mainly at german psychiatric hospitals). the central concern of this evaluation is to answer the question whether fit care offers advantages over standard care. the orientation of model care is a more cross-sectoral provision of services through more flexible psychiatric treatment intensities. however, fit program structures depend on the individual situation and organization of the fit hospital together with the participating statutory health insurance (shi) funds.

the introduction of section 64b of the german social code, book v (sgb v) created the possibility of agreeing so-called fit (flexible and integrated treatment) model projects for the further development of care for mentally ill people in germany. the objective is to improve cross-sectoral care or optimize patient care. more than 20 fit projects have been established at german psychiatric hospitals since 2013. some fit projects were prolonged after eight years (max. 15 years in sum). new fit projects are planned. in accordance with § 65 sgb v, all fit projects under § 64b sgb v, must be scientifically evaluated by an independent expert. the aim of this evaluation is to examine the achievement of the objectives of the fit model projects based on anonymized claims data. the effectiveness, costs, and cost-effectiveness of the fit model hospital care compared to standard care are to be examined. fit projects include those starting before 2022 and being prolonged and those fit projects starting between 2022 and june 2026. the study presented here is a controlled cohort study utilizing anonymous claims data. the controlled design is based on the fact that information of patients from intervention hospitals (any fit design) is compared to information of comparable patients from structurally similar psychiatric hospitals in the same federal state (petzold et al, gesundheitswesen 2019, 81(1):63-71).

Eligibility criteria:
inclusion criteria: * treatment in any of the participating hospitals or control hospitals within recruitment phase (number of hospitals will be fix until june 2026) * being insured with any of the participating shi funds exclusion criteria: * less than one year follow-up data available
evaluation of two different non-invasive techniques to monitor the clearance of actinic keratosis lesions

Conditions: Actinic Keratosis

Summary: the purpose of this study is to evaluate the performance of two techniques to monitor the clearance of ak lesions when treated with aldara 5% cream.

each technique will be assessed by comparison of lesion counts (clinical and sub-clinical) revealed by the techniques, at start and end of the study and those demonstrated during treatment. in addition a qualitative assessment of each technique will be made for performance and ease of use.

Eligibility criteria:
inclusion criteria: * at least 5 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic ak lesions * free of any significant findings (e.g tattoos) in the potential application site area. * willing to discontinue sun-tanning and use of sunbed/sun parlour use * willing to stop use of moisturisers, body oils, and over the counter retinol products or products containing alpha or beta hydroxyacids in the treatment or surrounding area. * willing ot withhold sunscreen and/or moisturiser use for 24 hours prior to each clinical assessment exclusion criteria: * evidence of unstable or uncontrolled clinically significant medical condition. * any dermatological disease and or condition in the treatment of the surrounding area that may be exacerbated by treatment with imiquimod. * currently participating in another clinical study or have completed another study within an investigational drug within the past 30 days. * have active chemical dependency or alcoholism * have know allergies to any excipient or study cream * have received previous treatment with imiquimod for any indication within the treatment area. * known to be affected by porphyria

Keywords: aldara actinic keratosis
a dose-finding study of jmkx003142 in treatment of cardiac edema

Conditions: Cardiac Edema

Summary: to evaluate the safety, efficacy, and pharmacokinetic/pharmacodynamics characteristics of jmkx003142 injection administered randomly,double-blind, placebo-controlled study in chinese cardiacl edema patients.


Eligibility criteria:
inclusion criteria: 1. can fully understand the purpose and process of the study and voluntarily sign the informed consent form; 2. age ≥ 18 years old when signing the informed consent form; 3. at the screening stage, it has been definitely diagnosed as heart failure, and it is combined with one of the following clinical manifestations related to body fluid retention: edema of both lower limbs, jugular vein engorgement, pulmonary congestion; 4. the screening phase is currently undergoing or preparing to use one of the following diuretic therapy as background treatment during the run-in period: 1) at least 40mg/day of furosemide equivalent loop diuretics; 2) any dose of loop diuretics combined with thiazide diuretics; 3) any dose of loop diuretics combined with aldosterone receptor antagonists or other potassium sparing diuretics. 5. after the background treatment in the run-in period, the subject still has the following two conditions: 1. one of the following clinical manifestations related to fluid retention still exists after the induction phase treatment: edema of both lower limbs, jugular vein dilatation, pulmonary congestion; 2. during the import phase, the weight of d-1 does not change by more than 1.0 kg compared to d-3. exclusion criteria: 1. edema caused by diseases other than heart failure； 2. subjects with ventricular assist devices during screening; 3. subjects diagnosed with active myocarditis, myocardial amyloidosis, hypertrophic cardiomyopathy (excluding dilated phase), or valve disease with obvious valve stenosis during screening; 4. acute myocardial infarction occurred within 30 days prior to screening; subjects with a history of persistent ventricular tachycardia or ventricular fibrillation within the 30 days prior to screening (those without implantable defibrillators); history of cerebrovascular disease within 6 months prior to screening (excluding asymptomatic cerebral infarction); 5. subjects with hypovolemia or suspected hypovolemia; 6. subject cannot feel thirst or have difficulty in fluid intake during screening; 7. during screening, the systolic blood pressure is less than 90mmhg or the diastolic blood pressure is less than 60mmhg; 8. administered with tolvaptan 14days before randomization ； 9. pregnancy (female pregnancy test positive) or lactation period;

Keywords: fluid retention heart failure
internet-based motomed exercise to reduce spasticity and improve physical function in persons with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: in an rct, the effect of the motomed movement trainer (reck, germany) on spasticity and physical function in pwms with edss score between 4,5 and 7 is investigated. all subjects exercise at home and are supervised and supported by an exercise therapist via an online platform. we compare the effect of a 12 week passive, motor-driven movement therapy (vg1) to an intermittent active and passive training (vg2). after 12 weeks, vg1 continues with an active training including strengthening exercises for another 12 weeks. vg2 does not receive any intervention in the second study phase.


Eligibility criteria:
inclusion criteria: diagnosed multiple sclerosis (mcdonald criteria) edss score between 5,5 and 7 diagnosed spasticity access to the internet exclusion criteria: lack of medical certificate for physical activity cognitive impairment clinically relevant internal disease, especially cardiovascular or pulmonary disease, metabolic and orthopedic diseases

Keywords: multiple sclerosis spasticity motomed training internet