Kornimate/medical-research-clean huggingface dataset:
a study of robatumumab (sch 717454, mk-7454) in combination with different treatment regimens in pediatric participants with advanced solid tumors (p05883, mk-7454-006)

Conditions: Neoplasms; Solid Tumors; Bone Cancer; Kidney Tumor; Neuroblastoma

Summary: this is a phase 1/1b, non-randomized, open-label, dose-escalation study of robatumumab (sch 717454, mk-7454) administered in combination with chemotherapy in pediatric participants with solid tumors, to be conducted in conformance with good clinical practices. this study will evaluate the safety, tolerability and dose-finding of robatumumab when administered in combination with temozolomide and irinotecan (arm a); or cyclophosphamide, doxorubicin, and vincristine (arm b), or ifosfamide and etoposide (arm c). the primary study hypothesis is that robatumumab can be safely administered in combination with chemotherapy regimens in pediatric participants with solid tumors.


Eligibility criteria:
inclusion criteria: * must be \<= 21 years of age (older participants may be allowed on study on a case-by-case basis); may be of either sex, and of any race/ethnicity. * must have histologic confirmation of the advanced solid tumor, except for brainstem tumors. * must have karnofsky performance score of \>=50 (if participant is \>16 years of age) or a lansky score of \>50 (if participant is \<=16 years of age). * must have adequate organ function during screening. * must be able to adhere to dose and visit schedules. exclusion criteria: * must not have a history of another malignancy. * must not have uncontrolled diabetes mellitus. * must not have persistent, unresolved common terminology criteria for adverse events (ctcae) grade \>=2 drug-related toxicity associated with previous treatment. * must not have known hypersensitivity to other antibodies, or any accompanying excipients associated with these medications. * if female, must not be breast-feeding, pregnant, intending to become pregnant, or have a positive pregnancy test at screening. * must not be known to have human immunodeficiency virus (hiv) infection or known hiv-related malignancy. * must not be known to have active hepatitis b, or hepatitis c. * must not have any serious or uncontrolled infection.
walnut consumption, endothelial function, and biomarkers

Conditions: Coronary Heart Disease; Type 2 Diabetes

Summary: this study will examine whether a twelve-week intervention with one ounce (28 g) per day of walnuts improves endothelial function measured non-invasively using finger probe (endopat-2000) in people with coronary heart disease or type 2 diabetes.


Eligibility criteria:
inclusion criteria: * age 30+ years * prevalent coronary artery disease * prevalent type 2 diabetes exclusion criteria: * current eating disorder * pregnant or lactating women * allergy to walnuts or other nuts * inability to provide informed consent or blood samples * history or prevalent diagnosis of cancer, asthma, kidney insufficiency, stroke, seizures, allergic disorders, or congestive heart failure * diagnosis of coronary heart disease or diabetes \< 1 year prior to enrollment * intention to move out of greater boston area within one year * current use of walnuts for more than 2 ounces per day * bleeding disorder * treatment with blood thinning drugs (i.e. warfarin, clopidogrel) * major surgical operation 3 months before or after screening * organ transplantation * current participation in another trial or plan to do so during the study * use of vasodilators such as nitroglycerin * inability to give informed consent * inability to travel to the study center at brigham and women's hospital

Keywords: endothelial function walnuts clinical trial nutrition cardiovascular disease
effects of expectations on negative affect, perceived cognitive effort, and pain

Conditions: Placebo; Expectations

Summary: the investigators administer a functional neuroimaging task to investigate the effect of cue expectancy on participants' self-reported ratings across a variety of affective and cognitive domains. the experiment incorporates three tasks in which participants experience and rate 1) somatic pain, 2) vicarious pain, and 3) cognitive effort. in the somatic pain task, participants receive a brief thermal stimulus administered to a site on their arm; in the vicarious pain task, participants watch a short video clip of a patient with back/shoulder pain; in the cognitive effort task, participants perform a cognitively demanding "mental rotation" task that requires them to indicate whether two 3d objects are the same or different when rotated along the y-axis. each trial follows a sequence that begins with a fixation, followed by a social influence cue, then an expectation rating, followed by a condition-specific stimulus, and then, an actual rating of the outcome experience. there are four events of interest: 1) cue perception, 2) expectation rating, 3) stimulus experience, and 4) outcome rating. first, participants are presented with a cue that depicts how other participants responded to the upcoming stimulus ("cue perception"). although the participant is told these are real ratings, they are in fact, fabricated data points that vary in intensity (low, high). then, based on the provided cues, participants are prompted to report their expectation of the upcoming stimulus intensity ("expectation rating") after providing an expectation rating, participants are presented with a condition-specific stimulus (somatic pain, vicarious pain, or cognitive effort) that also varies in three levels of low, medium, high stimulus intensity ("stimulus experience"). once the stimulus presentation has concluded, participants are prompted to provide an actual rating of their experience ("outcome rating"). for the somatic pain condition, participants rate their expectations and actual experience of how painful the stimulus was; for the vicarious pain condition, they rate their expectations and actual perception of how much pain the patient was in; and for the cognitive condition, the participant provides expectation and actual ratings of task difficulty.


Eligibility criteria:
inclusion criteria: * capable of performing experimental tasks (e.g., are able to read, can tolerate the maximum level of thermal pain stimuli). * fluent or native speakers of english exclusion criteria: * contraindications to magnetic resonance scanning (e.g., metal in body, claustrophobia, pregnancy) * substance abuse within the last six months * current or recent history of pathological pain * current or recent history of neurological disorders * currently or recent history of chronic pain * left-handed only

Keywords: social placebo somatic pain vicarious pain cognitive effort
left atrial appendage occlusion and biomarker evaluation

Conditions: Stroke; Atrial Fibrillation; Bleeding

Summary: "left atrial appendage occlusion and biomarker evaluation" (label) is a single-center, prospective and observational study evaluating changes of the expression of biomarkers in eligible patients before and after percutaneous implantation of a left atrial appendage (laa) occlusion device at mid-term follow-up.

this study will evaluate the changes of different types of biomarkers before and after successful percutaneous implantation of an laa occlusion device. biomarker evaluation will focus on blood derived biomarkers including neurohormones, proteins, cytokines, micrornas and metabolomics.

Eligibility criteria:
inclusion criteria: * non valvular atrial fibrillation, that makes anticoagulation to prevent embolic stroke from the laa * contraindication for the therapy with oral anticoagulants: * refusal to take oral anticoagulation * hasbled-score more than 3 * prior bleedings under oral anticoagulation exclusion criteria: * under 18 years * severely reduced left atrial function * mechanical heart valve * pulmonary embolism * deep vein thrombosis * myocardial infarction within the last 3 months * electrical cardioversion within 30 days after potential occluder implantation * atrial septum defect or interventional/surgical occlusion of asd * status after heart transplant * symptomatic carotid artery stenosis * transient ischemic attack (tia) or stroke within last 30 days * intracerebral bleeding within the last 2 months * acute infection * existing or planned pregnancy
neurodevelopmental disorders in youth with criminal behaviors

Conditions: Attention Deficit Disorder With Hyperactivity; Autistic Spectrum Disorder; Conduct Disorders in Adolescence

Summary: 1. describe the prevalence of neurodevelopmental disorders among youth with criminal behaviors 2. explore the relationship between specific neurodevelopmental disorders and the rates and types of crime 3. examine the roles of psychiatric comorbidities and sociodemographic factors in juvenile criminality


Eligibility criteria:
inclusion criteria: * juvenile offender from the juvenile affairs division of taipei city police department exclusion criteria: * not juvenile offender

Keywords: neurodevelopmental disorder criminality adolescence
assessment of lifestyle, blood pressure, cholesterol and glycated hemoglobin in a specific population

Conditions: Cholesterol; Lipidosis; Arterial Hypertension; Blood Glucose, High

Summary: the project shall we get to know your health better? lifestyle assessment, blood pressure and cholesterol in the population of libbs farmacêutica employeesltda.; consists of a study that will bring knowledge and enable quantificationof risk factors related to cardiovascular diseases in this population above mentioned.

the social relevance of this study is related to the knowledge and quantification of eating habits and lifestyles related to cardiovascular diseases in the population of employees, also referred to in this document as "employees", from libbs farmacêutica ltda. based on an observation and statistical analysis of the data obtained in this study, internal policies will be promoted that aim to improve eating habits, physical activity and decrease smoking.

Eligibility criteria:
inclusion criteria: * being an employee libbs farmacêutica ltda; exclusion criteria: * not applicable

Keywords: glycated hemoglobin cholesterol arterial hypertension smoking
volume-targeted versus pressure-limited noninvasive ventilation in patients with acute hypercapnic respiratory failure

Conditions: Acute Hypercapnic Respiratory Failure

Summary: volume-targeted noninvasive ventilation (vt-niv), a hybrid mode that targets a preseted tidal volume (vt) by automated adjustment of pressure support, could guarantee the delivered vt over pressure-limited noninvasive ventilation (pl-niv) with fixed level pressure support. whether vt-niv is more effective in improving gas exchange in patients with acute hypercapnic respiratory failure (ahrf) as compared with pl-niv remains unclear. our aim was to verify whether in comparison with pl-niv, use of vt-niv was more effective in correcting hypercapnia, hence reducing the need for intubation and improving survival in patients with ahrf.


Eligibility criteria:
inclusion criteria: * acute hypercapnic respiratory failure (ahrf) * arterial ph \<7.35 and ≥7.25 * paco2 \>45 mmhg exclusion criteria: * age \<18 years * excessive amount of respiratory secretions or weak cough * upper airway obstruction * recent oral, facial or cranial trauma or surgery * recent gastric or esophageal surgery * severe metabolic acidosis; severe abdominal distension * cardiac or respiratory arrest * pao2/fio2 \<150 mmhg * pneumothorax * severe ventricular arrhythmia or myocardial ischemia * severe hemodynamic instability despite fluid repletion and use of vasoactive agents * active upper gastrointestinal bleeding * lack of cooperation * refusal to receive niv
impact of general practice follow-up on emergency hospitalization of patients admitted for chest pain

Conditions: Chest Pain

Summary: this is a prospective observational study carried out in the emergency department of emile roux hospital. its aim is to compare the medical, psychological and social characteristics of patients followed up by a general practitioner and those without regular follow-up, using an anonymous questionnaire completed by the general practitioner in the emergency department, for patients consulting for the reason "chest pain".


Eligibility criteria:
inclusion criteria: * patient admitted to emile roux hospital emergency department with chest pain * patient affiliated to the social security system * patient able to give informed non-opposition to participating in research exclusion criteria: * patient under guardianship, curatorship, safeguard of justice or prisoners * patient with cognitive disorders * pregnant or breast-feeding women * refusal to participate

Keywords: emergency admission general practitioner
discovery elbow long-term survivorship

Conditions: Survivorship; Pain

Summary: the discovery™ elbow multi-center prospective study (5-year study) patients will be consented at the two year or next scheduled follow-up period for the early-enrolled patients.

eligibility: patient(s) must be enrolled in the discovery multi-center prospective study. the patient must consent to participation in the discovery long-term survivorship study. in order to continue to follow the multi-center subjects long-term biomet would like to extend the follow-up to include annual follow-ups from 10 to 15 years to document long-term survivorship. the annual follow-up will be obtained by sending annual questionnaire directly to the patients by mail. the patient ases questionnaire and survivorship data questions will be collected.

Eligibility criteria:
inclusion criteria: 1. participant in the discovery elbow multi-center study 2. consent to participate in the discovery elbow long-term survivorship study exclusion criteria: 1. patient is not a discovery elbow multi-center participant 2. patient does not provide consent for the discovery elbow long-term survivorship study

Keywords: elbow long-term survivorship study participant discovery elbow multi-center study who consent for the discovery elbow long-term survivorshipstudy
study of the link between complement activation and iga nephropathy severity

Conditions: IgA Nephropathy Severity in Kidney Transplantation

Summary: icone study (iga complement and nephropathy is a prospective monocentric observational study. the main objective is to evaluate the relevance of complement activation as a biomarker of disease severity and progression in patients with a biopsy proven igan.

iga nephropathy (igan) is a common cause of glomerulonephritis and a major cause of end stage renal disease in up to 20-40% of patients. however, its prognosis still cannot be accurately predicted due to the high heterogenicity of clinical presentations and courses. complement dysregulation is a main driver of glomerular damages in many glomerulonephritis. given the growing body of evidence of complement lectin/alternative pathways activation in igan pathogenesis, the investigators propose the evaluation of a combination of biomarkers of infra-clinical complement activation to stratify the risk of disease's progression. this study aims to identify subsets of patients in whom complement activation plays a critical role in disease progression. this is of particular interest in the aera of emergence of complement-targeting therapies in igan

Eligibility criteria:
inclusion criteria: * adult patients, male or female, with a biopsy proven iga nephropathy. * primitive and secondary forms can be included * regardless of the date of diagnosis and the level of kidney function * with or without past of kidney transplantation * followed in the nephrology department, strasbourg university hospital * signed informed consent exclusion criteria: * active or recent infectious or inflammatory syndrome (\<2 months), recent vaccination (\<2 months), ongoing acute humoral rejection treatment, treatment with plasma exchanges (\<2 months), current treatment with complement inhibitors * impossibility of giving informed information (emergency situation, difficulties in understanding, etc.) * subject under safeguard of justice, guardianship or curatorship
mechanisms and innovations in cardiac resynchronisation therapy

Conditions: Heart Failure; Left Ventricular Systolic Dysfunction; Left Bundle-Branch Block; Right Bundle-Branch Block; Non-Specific Intraventricular Conduction Defect

Summary: the aim of this study is to compare the effectiveness of multiple modalities of cardiac resynchronisation therapy using high precision acute electrical and haemodynamic measurements.these modalities include biventricular pacing and conduction system pacing utilising his bundle and left bundle pacing. conduction system pacing is a more physiological form of pacing. the study hypothesises that this will produce more effective cardiac resynchronisation.

this is a single centre acute electrical/haemodynamic and observational study of a subgroup of patients with heart failure. a total of 60 will be recruited. the acute study involves within patient comparison of biventricular and conduction system pacing using detailed electrical mapping and high precision haemodynamic measurement protocol. participants will have permanent conduction system pacing if; * baseline left bundle branch block and qrs \> 140ms or qrs \>150ms and any qrs morphology and * conduction system pacing is successful at reducing qrs duration by 20ms or more with satisfactory pacing parameters. participants who receive permanent conduction system pacing will have follow up at 6 weeks, 3 months, 6 months and 12 months. non-invasive markers including mechanical activation pattern (echocardiography and cardiac mri) and electrical activation pattern (ultra-high frequency electrocardiography) will be used to identify the characteristics of patients who benefit from conduction system pacing.

Eligibility criteria:
inclusion criteria: * patients referred for conventional crt * severe heart failure (lvef, a measure of heart pumping, \< 35% - severe) * prolonged qrs duration (\>120ms) * adults willing to take part (age \> 18 years) * able to give consent exclusion criteria: * unable to give consent * children (age \< 18 years) * pregnant women

Keywords: cardiac resynchronization therapy his bundle pacing haemodynamics ecgi
a study of jnj-80948543 in combination with other cd3 t-cell engagers in participants with relapsed/refractory b-cell non-hodgkin lymphoma (r/r b-cell nhl)

Conditions: Lymphoma, Non-Hodgkin

Summary: the purpose of this study is to determine the recommended phase 2 regimen (rp2r) for jnj-80948543 in combination with jnj-75348780 (part 1: dose escalation) and to further assess the safety of jnj-80948543 at the rp2r in combination with jnj-75348780 (part 2: dose expansion).


Eligibility criteria:
inclusion criteria: * histologic documentation of diffuse large b-cell lymphoma (dlbcl), including high-grade b-cell lymphoma and dlbcl arising from indolent lymphoma. all participants must have received at least 2 prior lines of therapy * participants must have measurable disease as defined by the appropriate disease response criteria * have an eastern cooperative oncology group (ecog) performance status of 0 to 1 * hematologic laboratory parameters must meet the required criterias and the values must be without a transfusion or growth factors for at least 7 days prior to the first dose of study drug * participants of childbearing potential must have a negative highly sensitive serum pregnancy test (beta (β)-human chorionic gonadotropin) at screening and within 24 hours before the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study exclusion criteria: * known active central nervous system involvement (cns) or leptomeningeal involvement * prior solid-organ transplantation * autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug * toxicity from prior anticancer therapy has not resolved to baseline levels or to grade \<= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be grade 2) * clinically significant pulmonary compromise defined as the need for supplemental oxygen to maintain adequate oxygenation * evidence of clinically significant and/or symptomatic infection (viral, bacterial, or fungal) at the time of study drug initiation. anti-microbial treatment for infection must be discontinued at least 7 days before the first dose of study drug
increased access to emergency contraceptive pills

Conditions: Pregnancy; Sexually Transmitted Diseases

Summary: this study will evaluate the effect of easy access to emergency contraceptive pills (ecps) on the rates of pregnancy and sexually transmitted infections (stis).

ecps are a back-up contraceptive method indicated for prevention of pregnancy after sexual intercourse if a primary contraceptive method fails or is not used. this trial will determine how increased access to ecps affects the probability of pregnancy and three stis. the stis tested in the study are chlamydia, gonorrhea, and trichomonas. the trial will also evaluate how ready access to ecps influences contraceptive or sti-prevention behaviors, particularly use of ecps themselves, use of condoms, and use of other contraceptive methods. the trial will be conducted among about 1,490 young women in the united states at high risk for pregnancy and stis. sexually active women aged 14 to 24 years who use barrier methods of contraception, oral contraceptive pills, or no contraception will be enrolled. each woman will be randomly assigned to either an advance provision group or a standard care group. in the advance provision group, women will be given a supply of ecps free of charge to keep at home in case of need. in the standard care group, women will be counseled about ecps and invited to come to the clinic to obtain them at usual clinic charges when necessary. participants will be seen for follow-up at months 6 and 12. at each visit, participants will be asked about pregnancies, stis, sexual activity, self-assessed sti and pregnancy risk, and use of ecps and other contraceptive methods. a specimen will be obtained for chlamydia, gonorrhea, and trichomonas testing.

Eligibility criteria:
inclusion criteria * sexual intercourse with a male partner at least twice in the month prior to study entry * does not desire pregnancy within 1 year of study entry * 6 weeks since the end of her last pregnancy and has had at least one menstrual period since resolution of her last pregnancy * literate in english or spanish exclusion criteria * surgically sterilized or intends to become sterilized within 1 year of study entry * intrauterine device or a hormonal implant in place or intends to have one inserted within 1 year of study entry * received an injection of a long-term contraceptive hormone (such as depot-medroxyprogesterone acetate) within 6 months of study entry or intends to receive one within 1 year of study entry * intends to use lunelle, the vaginal contraceptive ring, or the contraceptive patch for contraception within 1 year of study entry * intends to use partners' vasectomy as her method of contraception within 1 year of study entry * pregnant or breastfeeding * known or suspected infertility * previously participated in this study * planning to move out of the study area within 1 year of study entry * currently participating in another research study that would interfere with the conduct of this study

Keywords: emergency contraceptive pills pregnancy sexually transmitted infection chlamydia gonorrhea trichomonas contraception