Kornimate/medical-research-clean huggingface dataset:
combination plerixafor (amd3100)and bortezomib in relapsed or relapsed/refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this research study is to determine the safety of plerixafor and bortezomib, and the highest dose that can be given to people safely. plerixafor appears to stop myeloma cells from attaching to bone marrow and has been used in other phase i studies for mobilization of stem cells for patients with myeloma and lymphoma. we have shown that the combination of plerixafor and bortezomib is very effective in killing myeloma cells in the laboratory more than the effect of each drug alone.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * must have received prior 1-5 therapies for their myeloma and have relapsed or refractory multiple myeloma. prior therapy with bortezomib is allowed as long as they were not refractory to bortezomib * monoclonal protein serum of 1gm/dl or greater or monoclonal light chain in the urine protein electrophoresis of 200 mg/24 hours or greater, or measurable light chains by free light chain assay of 10 mg/dl or greater, or measurable plasmacytoma * ecog performance status 0, 1, or 2 * laboratory values as outlined in the protocol exclusion criteria: * uncontrolled infection * cytotoxic chemotherapy \< 3 weeks, or biologic or targeted novel therapy \< 2 weeks, or corticosteroids \< 2 weeks prior to registration. patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma * pregnant women * nursing women * men or women of child-bearing potential who are unwilling to employ adequate contraception * other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational * known to be hiv positive * radiation therapy \< 2 weeks prior to registration

Keywords: refractory relapsed bortezomib amd3100 plerixafor
targeted video messaging about emergency contraception

Conditions: Contraception

Summary: this research study will assess the real-world effectiveness of facebook advertising as a strategy to reach women of reproductive age who are at risk of unintended pregnancy with a brief educational intervention about emergency contraception (ec).

this research study will assess the real-world effectiveness of facebook advertising as a strategy to reach women of reproductive age who are at risk of unintended pregnancy with a brief educational intervention about emergency contraception (ec). the investigators will assess whether a video or website link has superior reach, engagement, and return on investment (measured as cost per click) through a facebook ad campaign. the investigators will also ensure that both modalities of consumer engagement (website and video) are efficacious at ensuring adequate and improved knowledge of emergency contraception through a laboratory-environment trial.

Eligibility criteria:
inclusion criteria: * women * 18 to 29 years old * living or seeking care in or around boston, ma * able to participate in an in-person visit at planned parenthood league of massachusetts (pplm) boston health center * english fluency * have at least one social media account (i.e. facebook, instagram, twitter, pinterest, youtube, snapchat) * endorse using social media at least once a week exclusion criteria: * pplm staff * currently or ever employed in the reproductive health field * currently using long-acting reversible contraception (larc) * history of permanent sterilization (by participant or sexual partner) * previous participation in the study
side-by-side comparison of p200te and spectral oct/slo on diseased eyes

Conditions: Retinal Disease; Glaucoma

Summary: this study is designed to evaluate and compare in-tissue performance of oct scans on the new optos p200te, versus the predicate optos spectral oct/slo device.


Eligibility criteria:
inclusion criteria: 1. male or female subjects 18 years of age or older who have full legal capacity to volunteer; 2. subjects who have signed the informed consent; 3. subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date; 4. subjects who agree to participate in the study; 5. subjects with current bscva 20/400 or better in the ocular disease study eye(s); 6. subjects diagnosed with ocular disease including but not limited to: macular degeneration, diabetic macular edema, diabetic retinopathy, central serous retinopathy, macular hole, epiretinal membrane, macular edema, glaucoma, and others in the retinal disease study eye(s) as confirmed at the study visit or within the past six (6) months. exclusion criteria: 1. subjects unable to tolerate ophthalmic imaging; 2. subjects with ocular media not sufficiently clear to obtain acceptable oct images; 3. subjects without ocular disease in study eye(s), as determined by self-report and/or investigator assessment at the study visit; 4. subjects with history of leukemia, dementia or multiple sclerosis.
trial of intratumoral injections of tti-621 in subjects with relapsed and refractory solid tumors and mycosis fungoides

Conditions: Solid Tumors; Mycosis Fungoides; Melanoma; Merkel-cell Carcinoma; Squamous Cell Carcinoma; Breast Carcinoma; Human Papillomavirus-Related Malignant Neoplasm; Soft Tissue Sarcoma

Summary: this is a multicenter, open-label, phase 1 study conducted to test intratumoral injections of tti-621 in subjects that have relapsed and refractory percutaneously accessible solid tumors or mycosis fungoides. the study will be performed in two different parts. part 1 is the dose escalation phase and part 2 is the dose expansion phase. the purpose of this study is to characterize the safety profile of tti-621 and to determine the optimal dose and delivery schedule of tti-621. in addition, the safety and antitumor activity of tti-621 will be evaluated in combination with other anti-cancer agents or radiation.

this is a multicenter, open-label, phase 1 study conducted to test intratumoral injections of tti-621 in patients that have relapsed and refractory percutaneously accessible solid tumors or mycosis fungoides. tti-621 (sirpα-igg1 fc) is a soluble recombinant fusion protein created by directly linking the sequences encoding the n-terminal cd47 binding domain of human sirpα with the fc domain of human immunoglobulin (igg1). tti-621 acts by binding human cd47 and preventing it from delivering an inhibitory "do not eat" (antiphagocytic) signal to macrophages. the study will be performed in two different parts: dose escalation and dose expansion. during the escalation part of the study, tti-621 was studied at 3 different dose levels and at different dosing frequencies to characterize safety, tolerability, pharmacokinetics, and to determine the maximum tolerated dose (mtd). during the expansion part of the study, tti-621 will be studied in an expanded group of patients at the maximum feasible dosing regimen determined in the escalation phase. after completion of their initial assigned therapy, subjects may receive continuation with tti-621. the expansion phase will further define safety and characterize efficacy of tti-621 alone and in combination with other anti-cancer therapies.

Eligibility criteria:
inclusion criteria: * histologically or cytologically documented, injectable cancer lesion (limited to solid tumors and mycosis fungoides) * adequate renal function * adequate coagulation function * adequate hepatic function * disease that has progressed on standard therapy or for whom there is no other therapy option available exclusion criteria: * central nervous system involvement * significant cardiovascular disease * active autoimmune disease * active hepatitis b or c or a history of hiv infection * uncontrolled infection * history of hemolytic anemia or bleeding diathesis

Keywords: cd47 sirpa immunotherapy checkpoint inhibitor
3d depth camera-based assessment of adolescent idiopathic scoliosisusing a depth camera

Conditions: Adolescent Idiopathic Scoliosis

Summary: adolescent idiopathic scoliosis (ais) is a common spinal deformity affecting adolescent health, and early diagnosis and accurate assessment are crucial for preventing disease progression. traditional assessment indicators, such as the trunk rotation angle (atr) and cobb angle, rely on clinical examinations and x-ray imaging, which have certain limitations, including radiation exposure and insufficient sensitivity. the back height difference (bhd), as a quantitative measure of the back surface morphology, may reflect the degree of trunk deformity caused by scoliosis. the use of the kinect v2 depth camera to capture three-dimensional point cloud data of the back provides a high-precision, radiation-free assessment method.


Eligibility criteria:
inclusion criteria: (1) adolescents aged 10-18 years, diagnosed with adolescent idiopathic scoliosis (ais) with a cobb angle ≥10°; (2) no history of spinal surgery or other corrective treatments; (3) able to undergo short-term inpatient treatment (5 days) and comply with study procedures. exclusion criteria: (1) patients with congenital, neuromuscular, or other secondary scoliosis; (2) presence of major comorbidities affecting spinal structure or muscle tone (e.g., spinal cord injury, muscular dystrophy); (3) patients unable to complete standardized assessment procedures.
biomonitor master study

Conditions: ATRIAL FIBRILLATION, Syncope

Summary: the biomonitor is an implantable cardiac monitor used to automatically detect and record episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial fibrillation. the study will be conducted to support regulatory approvals outside of europe. this biomonitor master study is designed to investigate the clinical efficacy and safety of the biomonitor.


Eligibility criteria:
inclusion criteria: * suspected cardiac arrhythmia or previous af diagnosis or af diagnosis before or after ablation procedure or stroke of unknown origin. exclusion criteria: * implanted icd or cardiac pacemaker * allergy to patch electrodes
amyloid beta and cognition in parkinson disease

Conditions: Parkinson Disease; Neurological Disorders

Summary: the investigators propose to study persons with parkinson disease (pd) with detailed clinical, cognitive and imaging at the time of study entry and repeat these assessments 2 years later. the study looks at how changes in activity of the neurotransmitter acetylcholine relates to changes in cognitive function and to see if there is presence or build up of amyloid protein.

participants with pd will be studied at initial visit assessing clinical, cognitive, and brain imaging. a one year and, if applicable, three year cognitive assessment will be done, and the entire/complete assessment (same as initial visit) will be repeated again at two years. there will be a maximum of three follow up visits. the imaging test battery will consist of amyloid and acetylcholine brain pet and mri scans. the use of acetylcholine pet imaging will demonstrate how changes in activity of this neurotransmitter relate to changes in cognitive functions, such as memory and mental concentration. a key question will be whether persons with pd who not only are losing acetylcholine brain cells but also have the buildup of the alzheimer amyloid protein have a more rapid progression with more severe cognitive decline and behavioral changes compared to persons who do not have the amyloid protein.

Eligibility criteria:
inclusion criteria: pd diagnosis according to the uk pd society of brain bank research center criteria pd subjects at risk for dementia age 50 and above, male or female absence of dementia confirmed by clinical and detailed neurological assessment - exclusion criteria: subjects with contra-indications to mr imaging evidence of large vessel stroke or mass on on mri use of cholinergic or neuroleptic drugs at baseline evidence of atypical parkinsonism on neurological exam subjects limited by participation in research procedures involving ionizing radiation pregnancy(test within 48 hours of each pet session) or breastfeeding -

Keywords: parkinson disease cognition
intrathecal analgesia for normal labour

Conditions: Labor Pain

Summary: primary outcome: compare the duration of analgesia. secondary outcome: analgesic potency of bupivacaine and fentanyl versus levobupivacaine and fentanyl.

the pain of childbirth is the most severe pain any women can endure in their life time. painful uterine contractions lead to maternal hyperventilation and increased catecholamine concentrations resulting im maternal and fetal hypoxemia. labour pain when unrelieved can have adverse effect on the course of labour as well as on the fetal wellbeing. an effective labour analgesia lead to better fetal and maternal outcome. although the gold standard in labour analgesia is utilization of epidural services which are widely used to provide pain-free labour in many parts of the world and and have the advantage of providing flexibility to meet the needs of each patient . epidurals have long been associated with increased oxytocin use, increased fetal malposition, increased rates of instrumental and cesarian delivery, and longer labour . the use of single-shot intrathecal low dose found to be effective . the advantages of this form of technique include the rapidity of onset and reliability, with minimal hemodynamic changes and motor block. spinal block is cheaper as well as less technically challenging when compared to epidural and combined spinal epidural block. intrathecal analgesia alone is useful when duration of labour can be reasonably estimated. opioid combined with a small dose of local anesthetic provides rapid analgesia and dissipates when no longer needed. bupivacaine because of its least placental transfer, due to high protein binding and minimal motor block compared to sensory block in lower doses, has become the popular choice for labor analgesia. addition of neuraxial lipid soluble opioids permitted reduction in the dose while maintaining effective analgesia and minimizing potential adverse effects on the progress of labor and lower extremity motor block . levobupivacaine is the s (-) enantiomer of racemic bupivacaine. previous studies have shown that it exhibits a clinical profile similar to bupivacaine with the added advantage of less motor impairment .

Eligibility criteria:
inclusion criteria: 1. singleton pregnancies 2. vertex presentation who will be in the active phase of labour with a cervical dilatation \>4cm 3. normal fetal heart rate. exclusion criteria: * 1-parturients with systemic diseases 2-suspected cesarian section which include, in order of frequency, labor dystocia, abnormal or indeterminate (formerly, nonreassuring) fetal heart rate tracing, fetal malpresentation, multiple gestation, and suspected fetal macrosomia. * 3 fetus with known or suspected congenital abnormalities, and 4-administration of parentral or oral analgesics before initiation of neuraxial analgesia will be excluded from the study.
irisin and diabetic nephropathy

Conditions: Irisin

Summary: diabetes mellitus (dm) is a complex, multifactorial, chronic metabolic and endocrine disorder. it has become a threat to global health. it has two types. it is estimated that the number of people with type ii will reach 700 million by 2045.

it is associated with acute and chronic complications, acute complications include hypoglycemia, diabetic ketoacidosis, hyperglycemic hyperosmolar state, and hyperglycemic diabetic coma. chronic complications are further divided into microvascular and macrovascular complications. chronic microvascular complications are neuropathy, retinopathy, and nephropathy. the later one firstly diagnosed by microalbuminuria. whereas chronic macrovascular complications are coronary artery disease (cad), peripheral artery disease (pad), and cerebrovascular disease. the conventional medications in diabetes treatment, oral and insulin, are focusing on insulin secretion and insulin sensitisation. oral antidiabetics include, biguanides, sulfonylureas, thiazolidinediones, dpp4 inhibitors, glp-1 analogue, and sglt2 inhibitors. irisin, a myokin and adipokine secreted by muscles and subcutaneous fat, is an interesting peptide performing significant functions in human health. irisin has been linked to human obesity and insulin resistance status. irisin is involved in regulating the mitochondrial function of muscle cells, so increases energy consumption of the body, promotes metabolism and reduces body weight so improves insulin sensetivity. in our study we aim to clarify the effect of antidiabetics on serum irisin in patients with typeii dm who developed diabetic nephropathy.

Eligibility criteria:
inclusion criteria: any patients above 40 years with type 2 diabetes of at least two years duration complicated with diabetic nephropathy. exclusion criteria: * patients below 40 yrs. * patients with type 1 diabetes complicated with diabetic nephropathy * type2 diabetes without nephropathy. * diabetic nephropathy cases on dialysis due to other causes * blood pressure more than 160/100 * acute coronary syndrome in the past 6 months * non alcoholic fatty liver disease, impaired liver function. * malignancy. * pregnancy * acute infection, acute inflammation. * severe renal impairment, and urinary tract infection.
virtual reality game playing in amblyopia therapy

Conditions: Amblyopia

Summary: background: "amblyopia is a neurodevelopmental disorder in both monocular and binocular functions and it extends even beyond the primary visual integration centers", therefore, amblyopia is not a "lazy eye" but it is a "lazy brain". purpose: the investigators aimed to compare the visual outcome of occlusion therapy with virtual reality game playing as a new therapy on amblyopic children. methods: this rct was performed on 50 children with unilateral amblyopia ,4 to 10 years old. they were randomly divided to case and control (each= 25) groups. case group were trained binocularly using the virtual reality games through head set for one hour a day, 5 days in a week for 4 to 6 weeks. controls occluded their non- amblyopic eyes, 2, 4 and 6 hours for mild (0.2 to 0.3 logmar), moderate (0.3 to 0.6 logmar) and severe (bcva \< 0.6 logmar) amblyopia, respectively.


Eligibility criteria:
inclusion criteria: - the best corrected visual acuity worse than 0.3 logmar exclusion criteria: * patients with abnormal fixation * patients with neurological problems * patients with any types of ocular pathologies
long-term effectiveness of abdominal sacrocolpopexy for the treatment of pelvic organ prolapse

Conditions: Prolapse; Urinary Incontinence

Summary: the colpopexy and urinary reduction effort (care) trial is a research study designed to evaluate whether the addition of a second surgical procedure in addition to a procedure for female pelvic organ prolapse (pop) affects the rates of urinary incontinence. this study will follow women in the care study for 10 years from the time of the surgery to compare success and complication rates in the two groups. recruitment into this study is open only to women that already participated in care. recruitment into care is closed.

the primary aims of this prospective cohort study are: 1. to determine the long-term (up to 10 years) anatomic success rate of sacrocolpopexy (defined as stage 0 apical prolapse and \<= stage 2 anterior and posterior prolapse and no re-operation or pessary treatment for pop), and whether anatomic success differs between women who had vs. those who did not have concomitant burch colposuspension at the time of sacrocolpopexy; 2. to determine whether there is a difference in long-term stress continence (by symptoms) between women who had vs. those who did not have concomitant burch colposuspension at the time of sacrocolpopexy; 3. to determine whether there is a long-term difference between overall pelvic floor symptoms and pelvic-floor specific quality of life between women who had vs. those who did not have concomitant burch colposuspension at the time of sacrocolpopexy.

Eligibility criteria:
inclusion criteria: * women enrolled in care exclusion criteria: * inability to provide informed consent. * subjects who, at the time of enrollment into e-care, are long-term residents of a skilled nursing facility (that is, residency is not limited to short-term rehabilitation).

Keywords: sacrocolpopexy abdominal sacrocolpopexy surgical procedure, prolapse pelvic organ prolapse urinary incontinence stress urinary incontinence
usability of levodopa cyclops™ vs inbrija® in parkinson's patients

Conditions: Usability

Summary: currently there is one levodopa inhaler on the market, the inbrija® inhaler. when looking at the user instructions for the inbrija®, multiple steps are necessary including preparing and cleaning the inhaler. the levodopa cyclops™ inhaler also requires steps to be ready-for-use, however there are less steps required to reach this 'ready-for-use' state. this is mainly because the medicine (levodopa) is already prefilled in the inhaler. moreover, the levodopa cyclops™ is a single-use inhaler and cleaning steps are not necessary. since both inhalers should be used during off episodes, there might be a preference for one inhaler over the other due to the instructions. an off episode might impair the ability and length to successfully operate an inhaler due to mental or mobility issues. this study investigates if parkinson patients have a preference for one of the inhalers based on handling steps, ease-of-use, understandability.

sixteen parkinson's patients, who are ≥ 18 years of age, regularly suffering from predictable off episodes, able to understand the inhaler user instructions (no cognitive dysfunction) and who did not previously participate in the parkinson dpi-1,2,3,4 or 5 study or in a study using inbrija®.

Eligibility criteria:
inclusion criteria: * diagnosed with parkinson's disease by a neurologist; * at least 18 years of age; * regularly suffering from predictable off episodes despite medication; * recognizable off episodes for themselves and others; * signed informed consent exclusion criteria: * not able to understand an inhalation instruction of either the levodopa cyclops™ or the inbrija® (within a maximum of 20 minutes of explanation per inhaler); * cognitive dysfunction, which precludes good understanding of instructions and/or informed consent; * previously participated in the parkinson dpi-1, dpi-2, dpi-3, dpi-4 or dpi-5 study (prior knowledge of the inhalation maneuver of the levodopa cyclops™) * having experience with using the inbrija® inhaler.

Keywords: parkinson