Kornimate/medical-research-clean huggingface dataset:
feasibility and efficacy of a home-based, computerized cognitive training program in pediatric sickle cell disease

Conditions: Anemia, Sickle Cell

Summary: disease-related neurocognitive deficits are common in pediatric sickle cell disease (scd). these deficits can significantly disrupt otherwise normal trajectories toward academic and vocational achievement and negatively impact psychosocial outcomes. despite widespread recognition of neurocognitive deficits, there are no treatments shown to maintain or recover functioning once a child with scd endures neuronal damage. cognitive training (ct) has been a standard intervention used to stabilize and recover functioning in individuals with accidental or disease-related brain injury. recent advances in technology have led to the development of computerized ct programs. this study seeks to assess the feasibility and efficacy of using computerized ct with pediatric patients with scd. children and adolescents with scd between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized ct program (cogmed). feasibility will be assessed by examining participation, retention, and program completion rates, as well as feedback from a feasibility and acceptability questionnaire and a brief qualitative interview. participants will also complete assessments of attention, working memory, and academic fluency at baseline and immediately following the intervention. a final assessment will be conducted 6 months after the conclusion of the intervention to evaluate the stability of treatment effects.


Eligibility criteria:
inclusion criteria: * diagnosed with sickle cell disease (hbss, hbsc, or hbs-beta thalassemia). * 7 to 16 years old. * an absolute or relative working memory deficit. * iq of 70 or greater, as measured via the wisc-v. * presence of a caregiver who is willing and capable of providing consistent support and supervision during cogmed training. exclusion criteria: * visual, motor, or auditory impairment that prevents computer use. * insufficient english fluency. * started taking or adjusted dose of medication to treat symptoms of adhd in the last 30 days. * unreliable access to a source of electricity to charge an ipad battery.

Keywords: neurocognitive working memory cogmed cognitive training
comparison of the efficacy & safety of resusix with fp24 in patients with acquired coagulopathy

Conditions: Coagulopathy

Summary: phase 2a study to assess the safety and efficacy of iv infused spray-dried solvent/detergent -treated plasma (resusix) when compared with an equal volume of plasma frozen within 24 hours after phlebotomy (fp24) in patients with liver disease who are actively bleeding or who require prophylaxis for surgical bleeding


Eligibility criteria:
inclusion criteria: * sbp 90-150 mm hg * acquired coagulopathy due to hepatic disease * inr \>1.4 * order for 1-4 units of plasma for active bleeding or prophylaxis for bleeding prior to surgery or invasive procedure * written informed consent * meld score: 25 or less (1st cohort), 35 or less (2nd cohort) exclusion criteria: * pregnant women * incarcerated patients * life expectancy less than 72 hours * severe bleeding at time of enrollment * hiv, sepsis, intracranial bleeding, congenital disorder, anti-phospholipid antibody syndrome or known lupus anticoagulant antibodies * receipt of plasma products, coagulation factor concentrates or anti-platelets within 3 days of enrollment * specific factor inhibitor activity or history of hypersensitivity to plasma-derived products * receipt of iv heparin within 24 hours of enrollment * use of a continuous infusion of an intravenous vasoactive medication * thrombocytopenia * bmi greater than or equal to 40 kg/m2 * participation in another clinical trial within 30 days of enrollment and received investigational product that may impact safety or efficacy of this study * west haven hepatic encephalopathy grade 3 or 4 (cohort 1) and grade 4 (cohort 2)
ravulizumab subcutaneous (sc) versus ravulizumab intravenous (iv) in adults with paroxysmal nocturnal hemoglobinuria (pnh) currently treated with eculizumab

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: the primary objective of this study is to evaluate pharmacokinetics (pk) of ravulizumab administered subcutaneously via an on-body delivery system (obds) compared with intravenously administered ravulizumab in adult participants with pnh who are clinically stable on eculizumab for at least 3 months prior to study entry.

the study will consist of up to a 30-day screening period, a 10-week randomized treatment period, and an extension period of up to 172 weeks.

Eligibility criteria:
inclusion criteria: * male or female ≥18 years of age * treated with eculizumab for pnh for at least 3 months prior to day 1 * ldh level ≤1.5 × upper limit of normal (uln) at screening * pnh diagnosis confirmed by documented high-sensitivity flow cytometry. * documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment. * body weight ≥40 to \<100 kilogram (kg) * female participants of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab. * willing and able to give written informed consent and comply with study visit schedule. exclusion criteria: * more than 1 ldh value \> 2 × uln within the 3 months prior to study entry * history of bone marrow transplantation. * history of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation. * unstable medical conditions (for example, myocardial ischemia, active gastrointestinal bleed, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, coexisting chronic anemia unrelated to pnh). * females who are pregnant, breastfeeding or who have a positive pregnancy test at screening or day 1. * participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study drug on day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.

Keywords: pnh
quantitative assessment of diffusion spectrum imaging in breast cancer

Conditions: Breast Carcinoma; Magnetic Resonance Imaging; Diffusion Spectrum Imaging

Summary: this project intends to prospectively collect patients with suspected breast malignant tumors by ultrasound or mammography. after routine mri scanning, all patients underwent diffusion spectrum imaging (dsi) sequence scanning. the inclusion criteria were as follows: (1) breast cancer was confirmed by surgery or biopsy. (2) pathologically diagnosis of estrogen receptor (er), progesterone receptor (pr), human epidermal growth factor 2 (her-2), ki-67, and lymphatic vessel invasion (lvi) status in breast cancer. (3) routine mri and dsi scans were performed within one week before the pathologic examination. the exclusion criteria were as follows: (1) patients who had received treatment before dsi scanning; (2) patients who underwent breast tumor biopsy within two weeks before dsi image acquisition; (3) pathology results of breast masses were other diseases besides breast cancer. (4) post-processing of dsi data cannot be performed due to poor image quality, such as motion artifacts. breast mri data were collected on a 3t mr scanner (magnetom skyra, siemens healthcare, erlangen, germany). all participants used standardized breast mri scanning schemes, including t2 weighted imaging (t2wi), t1 weighted imaging (t1wi), diffusion-weighted imaging (dwi), dsi, and contrast dynamic enhancement (dce). a total of 22 gsi quantitative parameters were derived from neudilab software that is based on the open-source platform dipy (diffusion imaging in python, http://nipy.org/dipy). the correlation between dsi quantitative parameters and pathological indexes (i.e., er, pr, her-2, ki-67, and lvi) was evaluated by spearman correlation analysis. the independent predictors of gsi quantitative parameters for different pathologic characteristics discrimination in breast cancer were determined by the logistic regression analysis. the predictive performance of dsi quantitative parameters for difference pathologic classifications was assessed by the receiver operating characteristic (roc) curves and their respective area under the curves (aucs).


Eligibility criteria:
inclusion criteria: 1. breast cancer was confirmed by surgery or biopsy. 2. pathologically diagnosis of estrogen receptor (er), progesterone receptor (pr), human epidermal growth factor 2 (her-2), ki-67, and lymphatic vessel invasion (lvi) status in breast cancer. 3. routine mri and dsi scans were performed within one week before the pathologic examination. exclusion criteria: 1. patients who had received treatment before dsi scanning. 2. patients who underwent breast tumor biopsy within two weeks before dsi image acquisition. 3. pathology results of breast masses were other diseases besides breast cancer. 4. post-processing of dsi data cannot be performed due to poor image quality, such as motion artifacts.
spinal cord gray matter imaging in post polio syndrome

Conditions: Post-polio Syndrome

Summary: this is a longitudinal, observational study with the aims of comparing spinal cord gray matter areas in patients with post-polio syndrome to age and sex matched healthy control subjects and to correlate atrophy with metrics of clinical disability.

post-polio syndrome (pps) is characterised by new muscle weakness, pain, and fatigue several years to decades after the acute polio infection. pathomechanisms are not yet fully understood. this is a longitudinal, observational study. the aims are (a) to detect spinal cord gray (and possibly) white matter atrophy in patients with post polio syndrome in comparison to healthy age and sex matched control subjects both cross-sectionally and longitudinally and (b) to correlate spinal cord gray and white matter atrophy to metrics of clinical disability. investigators will assess 20 patients with post-polio syndrome and 20 control subjects at baseline and 48 weeks by mri and clinically including quantitative muscle strength assessments.

Eligibility criteria:
inclusion criteria: * prior paralytic poliomyelitis with evidence of motor neuron loss. this is confirmed by history of the acute paralytic illness, signs of residual weakness and atrophy of muscles on neuromuscular examination, and signs of motor neuron loss. * a period of partial or complete functional recovery after acute paralytic poliomyelitis, followed by an interval (usually 15 years or more) of stable neuromuscular function. * slowly progressive and persistent new muscle weakness or decreased endurance, with or without generalized fatigue, muscle atrophy, or muscle and joint pain. symptoms that persist for at least a year. * exclusion of other neuromuscular, medical, and skeletal abnormalities as causes of symptoms. * patients older than 18 years at time of screening * ambulant * ability to walk 150 m in the 6 min walking distance (6mwt) with or without one or two walking sticks. exclusion criteria: * previous (3 months or less) or concomitant participation in any other therapeutic trial * known or suspected malignancy * other chronic disease or clinical relevant limitation of renal, liver, heart function according to discretion of investigator
one-month clinical evaluation of silicone hydrogel definitive 65 hpt contact lenses

Conditions: Ametropia

Summary: comparison of different contact lens materials.

this is a 1-month, open-label, bilateral, parallel-group, randomised, daily wear study. two-thirds of the subjects will wear the test lenses in both eyes, and one-third will wear the control lenses in both eyes.

Eligibility criteria:
inclusion criteria: * willing and able to sign informed consent form * ages 18 years or older * subjects must have owned spectacles or contact lenses prior to enrolment for this trial * spherical power between -10.00 d and +10.00 d (at vertex distance 0 mm) * astigmatic power ≤0.75 d exclusion criteria: * eye injury or surgery within 3 months immediately prior to enrolment for this trial * pre-existing ocular irritation that would preclude contact lens fitting * currently enrolled in an ophthalmic clinical trial * evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator * any use of medications for which contact lens wear could be contradicted, as determined by the investigator * current extended-wear users (sleep-in overnight) * current monovision lens wearers * pregnant women and nursing mothers * best-corrected visual acuity worse than 6/9 (logmar: +0.20; snellen decimal: 0.63)
a safety and efficacy study of cc-90011 in participants with relapsed and/or refractory solid tumors and non-hodgkin's lymphomas

Conditions: Lymphoma, Non-Hodgkin; Neoplasms

Summary: study cc-90011-st-001 is an open-label, phase 1, dose escalation and expansion, first-in-human (fih) clinical study of cc-90011 in subjects with advanced unresectable solid tumors (enriched for grade 2 nens, grade 2 nets and necs) and r/r nhl (mzl, including extranodal mzl \[emzl\], splenic mzl \[smzl\], nodal mzl \[nmzl\], and histologic transformation of mzl). the dose escalation part (part a) of the study will explore escalating oral doses of cc-90011 to estimate the maximum tolerated dose (mtd) of cc-90011. the expansion part (part b) will further evaluate the safety and efficacy of cc-90011 administered at or below the mtd in 3 selected expansion cohorts of approximately 10-20 evaluable subjects each, in order to further define the rp2d.


Eligibility criteria:
inclusion criteria: * advanced or unresectable solid tumors including those who have progressed on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer therapy or for whom no other approved conventional therapy exists * eastern cooperative oncology group performance status of 0 to 1 exclusion criteria: * prior autologous stem cell transplant ≤ 3 months before first dose or those who have not recovered * symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and gastrointestinal tract hemorrhages * impaired cardiac function or clinically significant cardiac diseases * poor bone marrow reserve as assessed by investigator refer to protocol defined exclusion criteria for parts c and d. other protocol-defined inclusion/exclusion criteria apply

Keywords: safety cc-90011 advanced unresectable solid tumors low intermediate-grade lung neuroendocrine tumors (typical and atypical carcinoids) neuroendocrine prostate cancer (nepc) r/r non-hodgkin's lymphomas
patient reported outcomes in patients with chronic migraine treated with botox®

Conditions: Migraine Disorders

Summary: this study will prospectively assess long term heath related quality of life in chronic migraine patients currently being treated with onabotulinumtoxina for injection (botox®) as standard of care.


Eligibility criteria:
inclusion criteria: -patients with chronic migraine eligible to receive treatment with onabotulinumtoxina (botox®) as standard of care. exclusion criteria: * diagnosis of hemiplegic migraine, basilar migraine, ophthalmoplegic migraine or migrainous infarction, chronic tension-type headache, hypnic headache, hemicrania continua or new daily persistent headache. * patient who is currently taking or planning on taking opioid-containing products, barbiturates or combination for acute headache or pain condition. * treatment with any other botulinum toxin product for any condition within 3 months of the screening visit. * diagnosis of myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function.
effect of serotonin level on constipation caused by chemotherapy in patients with ovarian, fallopian tube, or primary peritoneal cancer

Conditions: Constipation; Bowel Obstruction; Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Summary: rationale: gathering information about changes in serotonin levels in patients undergoing chemotherapy for ovarian cancer, fallopian tube cancer, or primary peritoneal cancer may help doctors learn more about constipation caused by chemotherapy. purpose: this clinical trial is studying how blood levels of serotonin effect constipation caused by chemotherapy in patients with newly diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

objectives: * to determine if there are any alterations in serotonin levels in patients undergoing chemotherapy for ovarian, fallopian tube, or primary peritoneal cancer and if this is associated with increased constipation. outline: patients undergo blood sample collection prior to beginning of planned postoperative chemotherapy, after 3 and 6 courses of chemotherapy, and at the 3-month surveillance visit. patients also complete a bowel function questionnaire at these time points.

Eligibility criteria:
inclusion criteria: * newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer * planned to undergo 6 courses of a taxane and platinum-containing regimen exclusion criteria: * ovarian low malignant potential tumor * history of constipation or irritable bowel syndrome * history of colorectal cancer * prior bowel resection at time of staging/cytoreductive surgery * prior abdominal-pelvic radiation * prior bowel surgery

Keywords: constipation, impaction, and bowel obstruction ovarian epithelial cancer peritoneal cavity cancer fallopian tube cancer
short course of amoxicillin for erysipelas

Conditions: Erysipelas

Summary: the propose of this study is to determine whether a 6-day duration of oral amoxicillin treatment of erysipelas is non-inferior to a 14-day standard duration intravenous then oral amoxicillin regimen. this trial will be open but evaluation will be perform by a blind evaluator.

to fight against increasing rate of bacterial resistance to antibiotics, several studies have demonstrated efficacy of short antibiotic course in e.g. acute streptococcal tonsillitis, community acquired pneumonia, and urinary tract infection. erysipelas is an acute dermo-hypodermal infection due to streptococcus. to date no resistance of theses bacteria to amoxicillin was described. the diagnosis of erysipelas is clinical. thus, short course of antibiotic is a good regimen to test in erysipelas treatment. to date there is no controlled trial concerning efficacy of oral amoxicillin in erysipelas treatment. expected advantages of the demonstration of the non inferiority of a short and oral amoxicillin treatment in erysipelas are: reduction of antibiotic selective pressure, cost, adverse events caused by infusion and hospitalisation.

Eligibility criteria:
inclusion criteria: * males and females ≥ 18 years of age * first episode of erysipelas of a lower leg defined as * acute well delineate inflammation than had lasted less than 5 days * t°≥ 38°5 at least once during the past 5 days or chills. * score ≥3 : oedema, erythema, pain each scored from 0 to 3 : 0= none, 1= moderate, 3= severe * written informed consent provided by the patient * available health insurance * accept conditions of the trial exclusion criteria: * erysipelas for more than 5 days * score \< 3 * septic shock * clinical signs of necrotizing cellulitis or fasciitis, bullous lesions related to necrosis, purpuric lesions or superficial cutaneous necrosis. * past history of erysipelas of the same lower leg * erysipelas not on the lower leg * bilateral erysipelas * bite occuring during the preceding 7 days. * diabetic foot * patients who have previously received systemic antibiotherapy within the last 5 days (except one or two doses within last 24 hours) * history of any hypersensitivity or allergic reaction to beta-lactam drugs * known renal or hepatic failure * known hiv infection * female patients who are pregnant, lactating (breast milk feeding), or who are of child bearing potential and not using an acceptable method of birth control * impossibility to stop immunosuppressive treatment, systemic corticosteroids or nonsteroidal anti-inflammatory drugs. * severe gastrointestinal disease, dysphagia or any pathology preventing oral administration of treatment. * denied to sign written informed consent * unable or unwilling to adhere to the study-specified procedures and restrictions * evolutive cancer under treatment

Keywords: amoxicillin erysipelas short course
neural mechanisms underlying children's responses to food portion size and energy density

Conditions: Pediatric Obesity

Summary: increased portion sizes of foods high in energy density (calories per gram of food) have been implicated in the obesity epidemic. numerous studies show that children and adults eat more from larger portions of food than they do from smaller portions, a response known as the portion size effect. despite the robust and consistent nature of these findings, the mechanisms underlying the portion size effect are not known. the long-term goal of this research is to identify the neural mechanisms involved in the portion size effect so that this information can be used to develop effective weight-management strategies. differences in neural response to food cues, as demonstrated by functional magnetic resonance imaging (fmri), can help clarify the factors that determine susceptibility to large portions. the goal of this study is to identify brain regions activated in response to portion size and energy density and relate these neural responses to laboratory eating behaviors in children. the investigators hypothesize that high relative to low energy density food images will be associated with increased activation in regions of the brain involved in reward- and sensory- processing and that large relative to small portion size food images will be associated with increased activation in regions of the brain involved in cognitive control. in addition, the investigators hypothesize that these brain responses will influence the relationship between portion size served and energy intake at laboratory meals.

what this study will add to the literature: the response to food images that vary by portion size using fmri has not been previously reported. furthermore, how the brain response to food portion size and energy density is related to energy intake has not been previously reported. the goal of this study is to identify brain regions activated in response to portion size and energy density and relate these neural responses to laboratory eating behaviors in children.

Eligibility criteria:
inclusion criteria: * right-handedness * english as native language * reading at /above grade level * not claustrophobic * generally healthy exclusion criteria: * left-handedness * metal in or on the body that cannot be removed * claustrophobic * medication usage that could alter brain activity * medical disorder that may impact comfort in scanner * food allergies

Keywords: magnetic resonance imaging portion size energy intake