Kornimate/medical-research-clean huggingface dataset:
a study of oral venetoclax tablet in combination with subcutaneous low-dose cytarabine (ldac) injection to assess adverse events in adult japanese participants with acute myeloid leukemia (aml)

Conditions: Acute Myeloid Leukemia (AML)

Summary: acute myeloid leukemia (aml) is a cancer of the white blood cells which perform many functions, including fighting bacterial infections and defending the body against parasites. this study will evaluate how safe venetoclax is and assess the adverse events in adult participants with aml. venetoclax in combination with low-dose cytarabine (ldac) is an approved therapy in the united states for patients with newly diagnosed acute myeloid leukemia (aml) aged \> 18 years with a medical condition that prevents the use of intensive chemotherapy. this study provides access to venetoclax in combination with ldac to participants over 18 years who are ineligible for intensive induction therapy. around 38 adult participants with diagnosis of aml will be enrolled in approximately 15 sites across japan. participants will receive oral venetoclax tablets once daily on days 1-28 in combination with subcutaneous low-dose cytarabine (ldac) injections once daily on days 1-10 of the 28-day treatment cycles. participants will attend regular visits during the study at a hospital to evaluate safety by medical assessments and blood tests.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of aml, previously untreated, ineligible for intensive induction regimen due to age or co-morbidities. * participants who are \>= 75 years of age or who are \>= 18 to 74 years of age with at least one of the following co-morbidities: * eastern cooperative oncology group (ecog) performance status of 2 or 3. * cardiac history of congestive heart failure requiring treatment or ejection fraction \<= 50% or chronic stable angina. * diffusion capacity of lung for carbon monoxide (dlco) \<= 65% or forced expiratory volume during the first second (fev1) \<= 65%. * adequate renal and hepatic criteria as described in the protocol. * other co-morbidities that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the abbvie therapeutic area medical director (ta md) before study enrollment. exclusion criteria: * history of prior treatment for aml with the exception of hydroxyurea, allowed through the first cycle of study treatment.

Keywords: acute myeloid leukemia (aml) cancer venetoclax, venclexta
crest-2 long-term observational extension study

Conditions: Stenoses, Carotid

Summary: the purpose of this long-term observational extension of participants in the crest-2 randomized clinical trial (c2loe - clinicaltrials.gov identifier: nct02089217) study is to study is to assess post-procedural efficacy of carotid endarterectomy and carotid stenting.

atherosclerotic plaque in the carotid arteries is responsible for 10 to 15% of all ischemic strokes. the ongoing ninds-funded crest-2 multicenter randomized clinical trial is testing whether in the short term (up to 4 years after study entry) procedural revascularization improves stroke prevention above and beyond what can be achieved with intensive medical management of vascular risk factors, especially hypertension and hyperlipidemia. our proposal is for an observational extension of the crest-2 clinical trial to test whether revascularization improves stroke prevention in the clinically relevant long term (up to 8 to 10 years). the current application proposes to use a site-less, centralized telephone approach to extend the follow-up of crest-2 trial participants for assessing the primary study outcome (stroke) for up to 10 years. the average follow-up will increase from between 2-3 years (clinic-based randomized trial) to 7-8 years (observational extension). each patient will be contacted by telephone at 6-month intervals, and queried regarding all hospitalizations since the last contact. suspected stroke events will be adjudicated by an expert clinical events committee based on medical record review.

Eligibility criteria:
inclusion criteria: * currently active or graduated participants in the crest-2 randomized trial * able to provide written informed consent by self * fluent in english or spanish exclusion criteria: * unable to provide written informed consent * inability to follow study procedures
study evaluating sc262 in subjects with r/r non-hodgkin's lymphoma (vivid)

Conditions: Non Hodgkin's Lymphoma; Large B-cell Lymphoma

Summary: sc262-101 is a phase 1 study to evaluate sc262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.

this is an open-label, single arm, phase 1, first-in-human (fih) study to evaluate the safety and tolerability of sc262 administered intravenously (iv) following a standard lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine in subjects with non hodgkin's lymphoma (nhl) who have received no more than 1 prior cd19-directed chimeric antigen receptor t-cells (car t) cell therapy. this study will be conducted in 2 parts. dose finding using a 3+3 design in subjects with nhl. dose expansion to further evaluate safety and efficacy at the recommended phase 2 dose (rp2d) in subjects with large b-cell lymphoma (lbcl).

Eligibility criteria:
inclusion criteria: 1. male or female subject aged 18-80 years at the time of signing the informed consent 2. histologic diagnosis of nhl (based on world health organization 2016 criteria) including: * lbcl, including diffuse large b cell lymphoma (dlbcl) not otherwise specified (nos) (including dlbcl arising from indolent lymphoma), primary mediastinal large b-cell lymphoma (pmbcl), high-grade b-cell lymphoma (hgbcl), and follicular lymphoma (fl) grade 3b * fl * marginal zone lymphomas (mzl) * mantle cell lymphoma (mcl) 3. relapsed or refractory disease after no more than 1 prior cd19-directed car t cell therapy 4. eastern cooperative oncology group (ecog) performance status of 0-1 5. at least 1 measurable (pet-positive) lesion per lugano classification 6. life expectancy ≥12 weeks exclusion criteria: 1. prior cd22-directed therapy including cd22-directed car t cell therapy or other cd22 -directed antibody or cell therapy (e.g., natural killer (nk) cell) 2. history of central nervous system (cns) involvement of lymphoma within 1 year prior to enrollment. 3. autologous hematopoietic stem cell transplantation (hsct) within 3 months before treatment with lymphodepleting (ld) chemotherapy (or allogeneic hsct at any time) 4. active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as \>10 mg/day prednisone or equivalent) 5. history or presence of cns disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with cns involvement, within 12 months of enrollment.

Keywords: large b-cell lymphoma car t cell therapy mantle cell lymphoma follicular lymphoma marginal zone lymphoma high-grade b-cell lymphoma primary mediastinal b-cell lymphoma diffuse large b-cell lymphoma non-hodgkin's lymphoma allogeneic hypoimmune cd22 sc262
a personalized self-management program for older adults with chronic pain and negative emotions

Conditions: Pain, Chronic; Negative Emotions

Summary: this study examines the effects of path-pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. half the participants will receive the intervention, and half the participants will receive usual care with education. intervention subjects are hypothesized to have significantly less pain-related disability versus usual care subjects after 24 weeks.

this study examines the effects of path-pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. the investigators propose that emotion regulation is the mechanism of change through which path-pain improves pain and pain-related disability (outcomes). this pilot study will provide initial evidence of the: a) feasibility and acceptability of path-pain; b) effects of path-pain on emotion regulation (mechanism of change) and outcomes (pain and pain-related disability); and c) mediating effect of emotion regulation (mechanism of change) on outcomes (pain and pain-related disability). the investigators will randomize 120 older adults (60 years or older) with chronic non-cancer related pain and negative emotions to path-pain vs. usual care with education (uce). path-pain will be administered by licensed mental health clinicians. research assessments will be conducted at the wright center at study entry (baseline), and at 5, 10 (end of treatment), and 24 weeks. additionally, 20 providers of patients will be interviewed for feedback regarding the intervention. edits were made in november 2024 to better align with the study protocol regarding timing and measures.

Eligibility criteria:
inclusion criteria patient participants: * 60 and older * chronic pain (pain on most days in past 2 months) * negative emotions * moca score 16 or higher provider participants: * providers 18 or over that took care of patient participant exclusion criteria - patient participants: * moca score \<16 * cancer related pain * can not provide capacity to consent
effects of internet-based diet plus online dietary coach compared with in person clinic visit approach on weight loss

Conditions: Obesity; Overweight

Summary: the purpose of this study is to examine the efficacy of an internet based diet plus a regular dedicated dietary coach (id group) versus clinic visit based weight loss program (cd group) on weight loss in obese and overweight female adults.


Eligibility criteria:
inclusion criteria: * must be female * must be 18-45 years of age. * must have body mass index (bmi) between 27-35 kg/ m². * must be able to have moderate exercise. * must be interested to have weight loss. * have access to a personal computer and the internet exclusion criteria: * pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months. * taking medications that could affect metabolism or change body weight. * report heart problems, chest pain, and cancer within the last five years. * smoking * menopause * diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Keywords: weight loss internet-based diet online dietary coach clinic visit approach diet
the prognostic value of cervical elastography for identifying patients at risk for preterm delivery

Conditions: Obstetric Labor; Labor Onset; Obstetric Labor, Premature

Summary: the hypothesis tested is that the physical changes associated with cervical ripening result in a detectable decrease in rigidity. the main objective of this study is therefore to determine whether the measured elastographic rigidity of cervical tissues in addition to cervix size can be used to predict delivery within the next 48 hours (creation of a prognostic score).

the secondary objectives of this study are: a-to compare the prognostic qualities of elastography scores and fetal fibronectin measurements for predicting the risk of delivery in the next 48 hours. b-to evaluate the economic impact of introducing elastographic and fibronectin measures during consultatios for obstetric emergencies from the point of vue of the french social security system and the hospital. c-to evaluate the prognostic value of elastographic measurements in the subgroup twins. d-to study elastography variation according to patient outcomes. e-evaluate the reproducibility of intra-and inter-rater elastographic measurements.

Eligibility criteria:
inclusion criteria: * the patient must have given her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * pregnant women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm) * single or multiple pregnancy exclusion criteria: * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient has lost her water (placental rupture) * history of cervical surgery

Keywords: elastography of the cervix cervical elastography predicting delivery
safety study of atomoxetine and cerebrovascular outcomes

Conditions: Cerebrovascular Accident; Transient Ischemic Attack; ADHD

Summary: using a proprietary insurance health claims database, eli lilly and company has contracted with an external party to conduct a retrospective cohort study of health claims for the time period from 1 january 2003 through 31 december 2006 (with follow-up of patients through 30 june 2007). this study will evaluate the potential association between atomoxetine and cerebrovascular events. in this study, the incidence of selected cerebrovascular outcomes as represented in health claims data among adult patients who initiate therapy with atomoxetine will be estimated. in particular the study will focus on cerebrovascular accident (cva) and transient ischemic attack (tia) as the outcomes of interest. the incidence for each outcome among atomoxetine initiators will then be compared to the incidence in a cohort of similar patients who initiate stimulant treatment and an age and gender-matched general population cohort. the atomoxetine and stimulant-initiating cohorts will be matched on a broad variety of variables, including age, gender, diagnoses, medication use, and healthcare utilization through the use of propensity score matching in order to minimize the influence of confounding by indication. the analysis will include the cohorts (atomoxetine and stimulant initiators) from a previous completed study with increased follow-up time (1 january 2003 through 30 june 2007) and accrue new atomoxetine and stimulant adhd medication initiators over a 2 year period, so that the study will represent initiators between january 1, 2003 and december 31, 2006 with follow-up through june 30, 2007.


Eligibility criteria:
inclusion criteria: * patients 18 years or older * received dispensing of one of the study medications during the time period of the study (january 1, 2003 - december 31, 2006) * 6 months of continuous enrollment prior to first dispensing exclusion criteria: * presence of pre-existing arrhythmia and heart failure during the baseline period

Keywords: cerebrovascular accident stroke transient ischemic attack tia cva attention deficit hyperactivity disorder adhd
heart rhythm after intravenous methylprednisolone administration

Conditions: Graves Disease; Graves Ophthalmopathy; Heart Rhythm Disorder; Hypertension; Blood Pressure; Heart Failure

Summary: high doses of intravenous (iv.) glucocorticoids (gcs) are commonly used as a treatment for many autoimmune and inflammatory disorders. according to the european group on graves' orbitopathy (eugogo) guidelines, intravenous methylprednisolone (ivmp) is an accepted first-line agent for active, moderate-to-severe and very severe graves' orbitopathy (go). this treatment is proven to be more efficient and safer than oral gcs. however, some patients may experience adverse cardiovascular effects during the administration of iv. gcs, which in rare cases may even be fatal. there are limited data, mostly obtained from case reports, reporting the occurrence of cardiac arrhythmias, acute myocardial infarction or heart failure. increased heart rhythm (hr) has drawn attention of researchers as a possible adverse effect correlated with ivmp. during this study, investigators performed 72-hours of holter ecg and ambulatory blood pressure monitoring (abpm) to evaluate the impact of ivmp on patients with moderate-to-severe go, concerning hr and blood pressure (bp) changes. in order to elucidate possible mechanism of observed changes, researchers investigated the level of potassium in serum and urine and catecholamines (epinephrine, norepinephrine) in serum. all patients were treated routinely according to eugogo recommendations with standard doses of methylprednisolone with standard recommended schedule. inclusion criterion for the therapy was according to eugogo guidelines active, moderate-to-severe and active go (12 pulses of ivmp 6x0.5g followed by 6x0.25g every week).

the clinical status of patients was evaluated before each pulse, including blood pressure monitoring, glucose level monitoring and symptoms of infection. hr and bp was measured continuously for 3 consecutive days (the day before, the day of ivmp and the day after ivmp) during 1st, 6th and 12th ivmp pulse, using 24-hour holter ecg and abmp. serum laboratory tests for potassium, epinephrine and norepinephrine were measured 3 times the day before and the day of first ivmp pulse and 1 time the second and sixth day after 1st ivmp. additionally, urine samples for potassium were collected 5 times the day of first ivmp pulse and 1 time the second and sixth day after 1st ivmp.

Eligibility criteria:
inclusion criteria: * active, moderate-to-severe go according to eugogo classification * euthyroidism * completion of 12 ivmp pulses. exclusion criteria: * cardiovascular morbidity (such as chronic heart failure and/or coronary heart disease) * uncontrolled hypertension (defined as systolic blood pressure (sbp) more than 140 mmhg and/or diastolic blood pressure (dbp) more than 90 mmhg) * contraindications to ivmp therapy * previous gcs treatment in the last 6 months.
probiotic intervention for occasional constipation

Conditions: Gut Function; Occasional Constipation

Summary: the goal of this clinical trial is to study the effect of probiotics on gut function in subjects with occasional constipation. the main question it aim to answer is if intake of probiotics will decrease the transit time. participants will randomized to either consume probiotics or a placebo product.


Eligibility criteria:
inclusion criteria: * males and females aged 18 - 65 years * with occasional constipation * agrees to maintain current lifestyle habits * healthy * provided voluntary, written, informed consent to participate in the study exclusion criteria: * individuals who are pregnant, breast feeding, or planning to become pregnant during the study * allergy, sensitivity, or intolerance to study products or clinical assessment materials * chronic constipation * current or history of significant diseases or abnormalities of the gastrointestinal tract (examples (include but are not limited to atrophic gastritis, celiac disease, gluten intolerance/sensitivity, inflammatory bowel disease) * unstable metabolic disease or chronic diseases * unstable hypertension. * type i or type ii diabetes, cancer * significant cardiovascular event in the past 6 months. history of or current diagnosis with kidney and/or liver diseases * self-reported confirmation of current or pre-existing thyroid condition. * individuals with an autoimmune disease or are immune compromised * self-reported confirmation of a hiv-, hepatitis b- and/or c-positive diagnosis, blood/bleeding disorders * any other condition or lifestyle factor, that may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Keywords: bowel movements gut function probiotics
dose proportionality and food effect of morphine sulfate

Conditions: Pain

Summary: establish the dose proportionality of the 15 mg and 30 mg morphine sulfate tablets and to examine the effect of food on absorption from the 30 mg tablet.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to morphine sulfate or any comparable or similar product.
effects of an ankle-foot orthosis on gait while performing an attention demanding task

Conditions: Stroke; Gait, Hemiplegic

Summary: we hypothesize that: (1) gait stability will be increased when wearing an ankle-foot orthosis (plastic brace supporting the foot and ankle); (2) an attention demanding task will decrease gait stability and (3) the improvement in gait stability due to ankle-foot orthosis use will be greater during an attention demanding task.

a quasi-experimental, randomized 2 x 2 factorial within subjects study with the factor of walking condition (2 levels, walking with and without ankle-foot orthotic device) and attention condition (2 levels, walking with and without attention task).

Eligibility criteria:
inclusion criteria: * be over the age of 18; * have the presence of hemiplegia after stroke; * be wearing an ankle-foot orthosis for at least 6 weeks; * be able to walk independently and comfortably for a minimum distance of 12 m with or without assistive aids (afos, canes and walkers); * be able to read and understand english, follow verbal instructions and provide verbal answers to questions; * be able to reach criterion on the attention task (described below) * be competent to give informed consent as determined by clinical team and noted in the health chart exclusion criteria: * have history of balance deficits not related to stroke; * be at high risk of falling during the study; * suffer from severe aphasia or dementia as determined by health chart and/or initial cognitive screening using the montreal cognitive assessment (moca) test.