Kornimate/medical-research-clean huggingface dataset:
study to evaluate adverse events and movement of intravenously (iv) infused abbv-787 in adult participants with relapsed/refractory (r/r) acute myeloid leukemia (aml)

Conditions: Acute Myeloid Leukemia

Summary: acute myeloid leukemia (aml) is the second most common type of leukemia diagnosed in adults and children, but most cases occur in adults. this study is to evaluate how safe abbv-787 is and how it moves within the body in adult participants with relapsed/refractory (r/r) acute myeloid leukemia (aml). adverse events and maximum tolerated dose (mtd) of abbv-787 will be assessed. abbv-787 is an investigational drug being developed for the treatment of aml. participants will receive abbv-787 in escalating doses until the maximum tolerated dose (mtd) is determined. approximately 60 adult participants with a diagnosis of aml will be enrolled worldwide. participants will receive intravenous (iv) infusions of abbv-787 during the approximately 3 year duration a participant is followed. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1. * laboratory criteria matching those outlined in the protocol. * qt interval corrected for heart rate (qtc) \<= 470 msec using fridericia's correction, and no other clinically significant cardiac abnormalities. * documented diagnosis of non-promyelocytic acute myeloid leukemia (aml), per 2022 european leukemia net (eln) criteria. * participants with relapsed/refractory (r/r) acute myeloid leukemia (aml) who have been treated with up to 3 prior lines of therapy and are refractory to or intolerant of all established aml therapies that are known to clearly provide clinical benefit at the judgement of the investigator. * must have a white blood cell (wbc) count \< 25 × 10\^9 /l prior to initiation of study drug (note: hydroxyurea or leukapheresis is permitted to meet this criterion and for use through cycle 3 to control for hyperleukocytosis.). exclusion criteria: * have received a cd33-targeting therapy within 3 months prior to the first dose of abbv-787. * stem cell transplant within 3 months prior to first dose of study drug. * have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 14 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of abbv-787. * history of documented pneumonitis that required treatment with systemic steroids within the last 6 months, nor any evidence of active pneumonitis. * unresolved toxicity of grade \>= 2 from prior anticancer therapy, or to levels dictated in the eligibility criteria, with the exception of alopecia. * known active severe or poorly controlled acute respiratory syndrome coronavirus 2 (sars-cov-2) infection.

Keywords: acute myeloid leukemia aml abbv-787
noninvasive treatment of upper trapezius active trigger points in college students with neck pain

Conditions: Neck Pain; Trigger Point Pain, Myofascial

Summary: hyperexcitable myofascial trigger points located within a taut band of skeletal muscle or fascia cause referred pain, local tenderness, and autonomic changes. the scientific data refer to an immediate improvement in the symptoms of these active points treated with manual therapy. based on these factors, the objective of the study is to determine the effect of the combined therapy of the jones, chaitow, lewit technique and pain-free positioning in participants with the presence of an active upper trapezius trigger point.

the treatment will last a total of 15 minutes accompanied by a baseline assessment and after 10 minutes of the intervention in 3 experimental groups and a placebo group, of no-pain positioning. in addition to basic indices and scales of cervical pain and functionality, it is intended to measure flexibility, range of motion, proprioception and cognition through software with sensors of the latest technology when it comes to representing reliable results in differences between techniques.

Eligibility criteria:
inclusion criteria: * persistent neck pain or headache for more than 3 days * presence of active trigger point in upper trapezius exclusion criteria: * participants who present dizziness, vertigo and/or symptoms aggravated by the movement and/or positioning of the neck; * who present infection or febrile state at the time of performing the test; * with anxiety and/or extreme emotional tension; * who are undergoing pharmacological treatment (analgesics, muscle relaxants, anxiolytics, antidepressants)

Keywords: physiotherapy rehabilitation treatment active trigger point
efficacy of self-expandable and balloon-expandable valves in patients with ascending aortic dilation

Conditions: Aortic Stenosis; Ascending Aortic Dilatation

Summary: this study evaluated the efficacy of self-expandable valves and balloon-expandable valves in patients with ascending aortic dilation who undergo transcatheter aortic valve replacement.

ascending aortic dilation (aad) is a common feature in patients with aortic stenosis, especially in those with bicuspid aortic valve. according to the 2022 aha/acc guideline for the diagnosis and management of aortic disease, in patients undergoing surgical aortic valve replacement who have a concomitant aad with a maximum diameter of ≥45mm, ascending aortic replacement is reasonable when performed by experienced surgeons in a multidisciplinary aortic team (class 2a, level b-nr). however, in patients undergoing transcatheter aortic valve replacement, the impact of ascending aortic dilation remains unclear. therefore, we designed this multicenter prospective randomized controlled trial, aiming to assess the efficacy of self-expandable and balloon-expandable valves in patients with aad with a maximum diameter of ≥45mm.

Eligibility criteria:
inclusion criteria: * severe as defined as an aortic valve area (ava) of 1cm2 or less or an indexed ava of 0.6 cm2/m2 or less; * evaluation and selection for tavr by the multidisciplinary heart team; * maximum ascending aortic diameter between 45mm and 54mm on preoperative contrast-enhanced computed tomography (ct) scan * anatomic suitability for a transfemoral vascular access; * life expectancy of more than 12 months; * age ≥65 years. exclusion criteria: * pure aortic regurgitation; * history of surgical or transcatheter aortic valve replacement (valve in valve); * history of any aortic surgery; * emergent surgery; * patients who refused to be randomized or unable to complete regular follow-up.

Keywords: transcatheter aortic valve replacement balloon-expandable valve self-expandable valve aortic stenosis ascending aortic dilation
a study of monthly subcutaneous continuous erythropoietin receptor activator (cera) in predialysis participants with chronic renal anemia

Conditions: Anemia

Summary: this single arm study will assess the long term maintenance of hemoglobin (hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (cera) in predialysis participants with chronic renal anemia. participants currently receiving subcutaneous darbopoetin alfa maintenance treatment will receive subcutaneous methoxy polyethylene glycol-epoetin beta for a maximum of 32 weeks at a starting dose of 120, 200 or 360 micrograms every 4 weeks according to the dose of darbopoetin alfa administered in week -1. subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to 12 grams per deciliter (g/dl).


Eligibility criteria:
inclusion criteria: * chronic renal anemia; * continuous subcutaneous maintenance darbopoetin alfa treatment during previous month; * hb concentration between 10 and 12 g/dl; * adequate iron status. exclusion criteria: * transfusion of red blood cells during previous 2 months; * significant acute or chronic bleeding, such as overt gastrointestinal bleeding; * poorly controlled hypertension requiring hospitalization or interruption of darbopoetin alfa treatment in the previous 6 months; * active malignant disease.
clinical outcomes of patients undergoing cabg surgery with vest supported venous grafts

Conditions: Coronary Artery Disease

Summary: this is a prospective, investigator-initiated, multi-center, open label and post-market registry, enrolling patients with atherosclerotic coronary artery disease, scheduled for cabg with at least one svg bypass. the registry is designed to evaluate the clinical outcome of cabg surgery with an external support device (vest) for svg bypasses. in each patient, use of the vest will be according to its approved indications for use and attempt will be made (based on clinical judgement) to support each non-sequential svg bypass graft with a vest device. subjects will be followed for 5 years, with interim follow ups at 12 and 24 months. macce and eq5d3l will be documented at every follow up visit.


Eligibility criteria:
inclusion criteria: 1. patient scheduled for planned cabg procedure with at least one svg bypass with pre-planned vest treatment. 2. saphenous vein graft length and diameter are adequate for the planned intervention. 3. patient is willing and able to give their written informed consent to participate in the registry study. 4. patient is over 18 years of age exclusion criteria: 1. emergency cabg surgery (cardiogenic shock, inotropic pressure support, iabp) 2. participating in any other investigational study for either drug or device which can influence collection of valid data under this study

Keywords: coronary artery bypass surgery cabg external support
environmental chemicals and their role in obesity

Conditions: Obesity

Summary: hormonal disruption is the inappropriate alteration of the hormonal system by chemical substances that are present in our environment. some chemical substances are capable of replicating, enhancing or reducing the production, release, transport or action of natural hormones. therefore, they are called hormonal or endocrine disrupters. some 'classic' endocrine disrupters such as pesticides and dioxins are considered responsible for infertility, cancer and thyroid problems. recently, a number of additional chemical substances were stipulated to have endocrine disrupting capabilities. the industrial production of these substances in large quantities has led to an accumulation in our environment and thus possible negative consequences on human health. the aim of this study is to investigate the rol of these chemical substances in the occurence of overweight and obesity.


Eligibility criteria:
inclusion criteria: * adult * overweight (bmi \> 25 kg/m²) or obesity (bmi \> 30 kg/²) exclusion criteria: * type 1 diabetes mellitus * psychiatric illness
study of 18f-dcfpyl pet/ct imaging in patients with prostate cancer

Conditions: Prostate Cancer

Summary: this study evaluates the safety and diagnostic performance of 18f-dcfpyl injection in patients with at least high risk prostate cancer who are planned for radical prostatectomy with lymphadenectomy (cohort a) or in patients with locally recurrent or metastatic disease willing to undergo biopsy (cohort b). cohort b is complete and no longer recruiting subjects.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed adenocarcinoma of the prostate. 2. subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements. cohort a only: * at least high risk prostate cancer defined by nccn guidelines version 3.2016 (clinical stage ≥t3a or psa \>20 ng/ml or gleason score ≥8). * scheduled or planned radical prostatectomy with plnd. cohort b only: \[enrollment is complete; no longer recruiting subjects\] * radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (ct, mri, or ultrasound), whole-body bone scan (99m-tc-mdp or na-18f) within 4 weeks of enrollment. * if prior treatment with radiation or ablative therapy, evidence of recurrence outside the confines of prior treated site(s) is needed. * scheduled or planned percutaneous biopsy of at least one amenable lesion. exclusion criteria: 1. subjects administered any high energy (\>300 kev) gamma-emitting radioisotope within five physical half-lives, or any iv iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection. 2. subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion. cohort a only: * patients with prior androgen deprivation therapy or any investigational neoadjuvant agent or intervention cohort b only: \[enrollment is complete; no longer recruiting subjects\] * prior radiation or ablative therapy to intended site of biopsy, if within the prostate bed * initiation of new therapy for recurrent and/or progressive metastatic disease since radiographic documentation of recurrence/progression.

Keywords: diagnostic imaging 2301 pet/ct pyl psma radical prostatectomy metastatic prostate cancer recurrent prostate cancer
effect of leqembi on cerebral and retinal amyloid in mild cognitive impairment due to alzheimer's disease

Conditions: Mild Cognitive Impairment; Alzheimer Disease

Summary: this is a proof of concept observational study is to determine if there is correlation between aβ plaques and vascular findings in the retina versus brain aria.

based upon studies and histological evidence, investigators and study sponsor suspects that the primary mechanism that causes caa in the brain (and increased risk of aria) may also occur in the retina. investigators propose use of both amyloid brain pet imaging, mri, and retinal imaging to determine if patients undergoing lecanemab treatment allows for in the ability to correlate aria from retinal amyloid and vasculature versus mri criteria, and a measurable reduction in amyloid in the retina when compared with amyloid pet scans of the brain post-treatment.

Eligibility criteria:
inclusion criteria: 1. subjects must be eligible for and intend to receive leqembi under standard of care treatment. 2. male and female subjects ages ≥50 years old. 3. must be willing to comply with protocol including pupillary dilation to a minimum of 3.5 mm to allow for ocular imaging. 4. patient or patient's legally authorized representative (lar) (e.g., spouse or legal guardian) has the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (phi) in accordance with national and local patient privacy regulations. exclusion criteria: 1. history of acute angle-closure glaucoma or allergic reaction to the protocol-specified ophthalmic medication for dilation of the pupils. 2. self-reported or diagnosed history of dense cataracts or other significant media opacity that may affect clear images of the retina. 3. subjects must not have had eye surgery in the past 2 months, be currently administering eye drops relating to previous eye surgery, 4. unable or unwilling to comply with the protocol requirements.

Keywords: retinal image caa leqembi lecanamab
evaluating 18f-fdg pet/ct with liver suvmax-based criteria for prognosis of patients with peripheral t-cell lymphoma

Conditions: Lymphoma, T-Cell, Peripheral

Summary: the purpose of this study is to evaluate whether a semi-quantitative interpretation using the liver suvmax as reference can better interpret 18f-fdg pet/ct and predict disease progression during chemotherapy or survival in ptcl.

in this study investigators develope a semi-quantitative interpretation using the liver suvmax as reference to interpret 18f-fdg pet/ct. positive lesions in pet were indicated as suvmax of residues higher than the threshold or new 18f-fdg avid lesions. investigators compare the prognostic accuracy of the liver suvmax-based criteria with the 5-ps criteria and δsuvmax interpretation with respect to predicting disease progression during chemotherapy or survival in ptcl. furthermore,investigators improve the prognostic ability of interim pet/ct by comparing the results to the clinical prognostic factors.

Eligibility criteria:
inclusion criteria: * newly diagnosed ptcl * treated using an anthracycline-containing regimen * minimal follow-up at 6 months after the completion of first-line treatment * complete medical history and clinicopathological data exclusion criteria: * secondary malignant disease * serious infection or inflammation (e.g., hiv) * primary central nervous system lymphoma * hepatic or renal dysfunction.

Keywords: lymphoma, t-cell, peripheral positron-emission tomography prognosis
reducing port access pain and clinic wait time: an evaluation of emla cream versus nüm™ vapocoolant spray

Conditions: Pediatric Cancer

Summary: the goal of this clinical trial is to compare a sterile vapocoolant spray to emla cream in children with access ports. participants will receive either the spray or cream prior to port access and rate pain on a scale. researchers will compare spray vs cream to see if the spray is as effective as the cream in reducing pain associated with port puncture.


Eligibility criteria:
inclusion criteria: * english-speaking * present appointment is for drawing blood, receiving intravenous antibiotics, blood products, or chemotherapy * emla cream has (standard of care) or has not (vapocoolant) been applied to the port site prior to the appointment * previous allergic reaction or skin irritation due to emla * quick access to the child's port is needed for drawing blood, or giving treatments, blood products, or drugs such as chemotherapy exclusion criteria: * child has a legal guardian or non-parent family member as the only adult with them for the visit. * children less than 4 years of age * children with altered mental status * history of traumatic brain injury, developmental delay or autism * child is nonverbal * present appointment is for drawing blood, receiving intravenous antibiotics, blood products, or chemotherapy, and child and parents prefer to wait for emla cream to take effect.

Keywords: port access pain pediatric oncology
comparative abuse liability among african american and white smokers

Conditions: Tobacco Use Disorder

Summary: the study is a randomized crossover trial. current smokers will complete a session with each product: usual brand cigarette, e-cigarette, and heat-not-burn. the objective of this survey is to assess for ongoing use of study products and is part of safety monitoring.

the study is a randomized crossover trial. current smokers will be randomized to session order and complete a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with each product (usual brand cigarette, e-cigarette, heat-not-burn). throughout each visit, blood will be collected for nicotine analysis via an iv catheter placed in the patient's arm. blood samples will be aliquoted into two separate vials. one will be analyzed for the current study and one will be placed in a biospecimen repository if participant provides consent for biorepository. puff topography will be collected passively throughout the session to measure puffing patterns. participants will complete self-report measures of nicotine withdrawal and craving. finally, breath samples will be collected to measure changes in exhaled carbon monoxide, a potent lung toxicant, pre- and post-product use. at the final visit, participants will complete a behavioral economics concurrent choice task (see below for description) to behaviorally measure their decisions regarding use of e-cigarettes or heat not burn products in place of cigarettes. finally, participants will be contacted by phone 6 months following the conclusion of visit 3 (or study discontinuation) to complete a phone survey. the objective of this survey is to assess for ongoing use of study products and is part of safety monitoring. we have no hypotheses related to the follow-up.

Eligibility criteria:
inclusion criteria: * non-hispanic african american or white/caucasian, * ≥21 years old, smoke 5-30 cigarettes per day, * daily cigarette smoker * smoked at current rate for at least 6 months * interested in trying e-cigarettes and heat not burn products * not interested in or unable/unwilling to quit cigarette smoking * willing to complete three in-person study visits * willing to have iv catheter placed exclusion criteria: * interested in quitting cigarettes in the next 30 days * use of smoking cessation pharmacotherapy in the past 30 days * use of non-cigarette tobacco products in the past 30 days * use of e-cigarettes \>5x in lifetime * use of e-cigarettes ≥4 of the past 30 days * use of heat not burn products \>5x in lifetime * use of heat not burn products ≥4 of the past 30 days * weight \< 110 lbs * uncontrolled hypertension (systolic bp ≥ 180 or diastolic bp ≥ 105) * pregnant, plans to become pregnant, or breastfeeding * live \>10 miles from study site (fairway cru) * current enrollment is a research study or program that aims to alter tobacco use
effects of intensity-matched agility and cycling exercise training on pd patients' clinical symptoms, posture, and mobility

Conditions: Parkinson Disease; Balance; Rehabilitation; Motor Function

Summary: determine the short-term and lasting effects of intensity-matched exercise programs on level 2-3 pd patients' clinical symptoms, postural control, and mobility. hypothesis 1. the inclusion of a borg-scale/heart-rate matched active control group will allow us to test the idea that, in addition to a fitness element, the reflexive movements that chellenge pd patients' sensorimotor system will improve patients' clinical symptoms, posture, and mobility more than fitness training and that such lasting effects will be superior in the agility compared with the fitness-control group. this hypothesis emered from the idea that the favorable results in the currently under review paper may be in part due to a simple conditioning effect instead of a specific motor learning effect caused by the xbox training. 2. if feasible, i.e., if there is a lerge enough pool of patients to randomize, a balance training group will be also added to test the idea that the reflexive actions evoked by the agility program by xbox exergaming still produce superior adaptations vs. the balance group because xbox forces patients to rapidly and reflexively execute movements (respond to cues, prompts), while balance training allows patients to stop, go, stop, and go and disrupt the continous execution of linked movements. the disruptions of movement chains could arise from small losses of balance on the unstabel surfaces, need for patients to re-initiate every movement element of a sequence, planning each movement element. it is not clear yet how it woul be possible to match all three intervention groups on borg/heart rate intensity.

agility: xbox based high intensity program, as detailed in the submitted manuscript. borg scale after after each exercise block is recorded. heart rate continuosly measured. these data are used to set intensity in the fitness group. fitness: a stationary bicycle ergometer program that includes visual stimulation in the form of watching nature programs and movies to account for visual stimulus in agility group. mean heart rate and borg scale readings from agility group will form the target intensity. control: no-exercise, measurment-only control group.

Eligibility criteria:
inclusion criteria: * parkinson's disease, * hoenh yahr scale of 2-3, * instability problem, exclusion criteria: • severe heart problems, severe demeanor, alcoholism, drug problems,

Keywords: sensorimotor training quality of life posture