Kornimate/medical-research-clean huggingface dataset:
oral arsenic trioxide for npm1-mutated aml

Conditions: NPMc+ AML

Summary: a prospective open-label phase 2 study will be designed to assess the efficacy of oral arsenic trioxide plus azacitidine in preventing relapses in patients with npm1-mutant aml. after screening and eligibility assessment, patients will receive treatment with oral arsenic trioxide plus azacitidine for 12 months. the recruitment period will last for 24 months and it will take approximately 36 months for study completion.

eligible subjects with npm1 mrd positivity will receive oral arsenic trioxide (oral-as2o3) (arsenol ®) (5-10mg per day, from days 1-7 per cycle), ascorbic acid (1g per day, from days 1 - 7 per cycle) plus azacitidine (75mg/m2 per day subcutaneously, from days 1 to 3 per cycle). each cycle of oral-as2o3 plus azacitidine will be given once every 28 days. the total duration of treatment is 12 months (12 cycles). treatment will be day-care and outpatient based. reduction in the dosage and duration of oral-as2o3 is required if the subject is experiencing adverse events (aes). in case of grade 3 or above toxicity, the dosage of oral-as2o3 will be reduced to 5mg per day. changes or interruption in dosages, their dates and time points will be recorded on the dosage administration record and the electronic case report form (ecrf).

Eligibility criteria:
inclusion criteria: 1. adults ≥ 18 years 2. diagnosis of aml with npm1 mutation 3. positive mrd for npm1 mutation after completion of consolidation in transplant-ineligible patients 4. positive mrd for npm1 mutation after allogeneic hsct 5. bilirubin ≤ 1.5 x upper limit normal (uln); alanine aminotransferase (alt) ≤ 2 x uln or aspartate aminotransferase (ast) ≤ 2 x uln; and prothrombin time versus control \<3 seconds at screening 6. glomerular filtration rate ≥ 50 ml/min (by mdrd equation or cockcroft-gault formula) 7. corrected qt interval (qtc) (by framingham formula) \<500ms. 8. able to give a written informed consent and fully comply to the requirements of the study. exclusion criteria: 1. patients on other investigational therapies 2. prior exposure to azacitidine, decitabine or arsenic trioxide 3. uncontrolled graft-versus-host disease (gvhd) 4. eastern cooperative oncology group (ecog) performance status \> 2

Keywords: npm1 mutation acute myeloid leukemia oral arsenic trioxide
study of program interest "bouge" to improve the daily physical activity in processings treatment of non-metastatic breast cancer

Conditions: Physical Activity; Breast Cancer; Mobile Health Apps

Summary: evaluate the "bouge" digital program (smartphone application) to increase the daily physical activity of breast cancer patients

controlled, randomized, open, prospective, multicentric study, 214 volunteer patients aged between 18 and 70, with breast cancer, at the start of taxol treatment, possessing a smartphone, will be recruited and randomized into two groups: 107 in the control group (smartphone application "placebo" = number of steps) 107 will be equipped with the application "bouge" = coached group for three months, the patients do their daily physical activity. the "coached" group, through the smartphone application "bouge", receives computer coaching to increase their physical activity (no direct medical intervention, only notifications and computer pusch). the control group is not coached by the application (simple display of the number of step)

Eligibility criteria:
inclusion criteria: non-metastatic breast cancer start of treatment with taxol compatible smartphone exclusion criteria: age metastatic breast cancer
discovering new biomarkers for monitoring disease progression in patients with mucopolysaccharidosis iva

Conditions: Mucopolysaccharidosis Type IVA

Summary: the purpose of this study is to find out more about some of the unusual chemicals (called oligosaccharides) that can occur naturally as a result of processes in the body. researchers want to look at how these chemicals change with time and how they change between different patients with mpsiva. these unusual chemicals were recently discovered in the urine from patients with mpsiva. the investigators would like to study these chemicals before a specific enzyme replacement therapy is used. if the investigators understand how these chemicals change, the investigators may be able to use them to monitor this condition in the near future as well as help doctors know whether certain therapies work well in their patients.

this is not a clinical trial and there is no outcome measurement. the biomarkers in this study are oligosaccharides that secreted in the urine from patients with mpsiva. in this study, we will try to define the variability of these oligosaccharides in the same patient at different time points, including different month of a year and different collections during the day as well as variations of these oligosaccharide in different affected patients.

Eligibility criteria:
inclusion criteria: * diagnosis of mucopolysaccharidosis iva exclusion criteria: * patients receiving enzyme replacement therapy.

Keywords: mucopolysaccharidosis type iva mucopolysaccharidosis type iv mps type iva mps type iv morquio syndrome morquio syndrome type a urine biomarkers
protocol for assistance to patients with long covid-19 undergoing treatment with hd-tdcs

Conditions: Coronavirus; COVID-19 Respiratory Infection

Summary: covid-19 is an infectious disease which presents a heterogenous clinical presentation. recent investigations suggest that people who were infected by covid-19 often develop physical disabilities (i.e. pain, fatigue) and neurological complications after hospital discharge. many therapeutic approaches such as transcranial direct current stimulation high definition (hd-tdcs) have been proposed to minimize functional and structural impairments. recently, i electroencephalogram (eeg) has been used as predictor of hd-tdcs effectiveness in diverse neurological populations. however, evidences about this tool utilization as efficacy predictor of tdcs in covid-19 people rest inconclusive. thereby, our objective is to evaluate hd-tdcs efficacy on fatigue, pain and functional capacity of patients with covid-19 chronic.

we propose a sham-controlled randomized clinical trial with patients in covid-19 chronic. they will be evaluated according to following eligibility criteria : patients who had a medical diagnosis of covid-19, clinically stable, able to respond to simple commands, able to walk for six minutes and who sign study consent form will be enrolled. those who present associated neurological diseases, pregnant, users of psychoactive drugs, patients who have metallic implants, electronic devices, pacemakers, or epileptic patients will be excluded. patients will be allocated randomly to the experimental group or sham control. sessions for experimental group consist of anodal hd-tdcs on left diaphragmatic primary motor cortex associated to respiratory training (10 sessions, 3ma, 20 minutes/session). in the sham condition, the device provided a 30-second ramp-up period to the full 3 ma, followed immediately by a 30-second ramp down. patients will be assessed in three moments: pre-treatment, post-treatment and after 30 days treatment ending (follow-up).

Eligibility criteria:
patients who had a medical diagnosis of covid-19, clinically stable, able to respond to simple commands, able to walk for six minutes and who sign study consent form will be enrolled. those who present associated neurological diseases, pregnant, users of psychoactive drugs, patients who have metallic implants, electronic devices, pacemakers, or epileptic patients will be excluded.

Keywords: covid-19 respiratory infection transcranial direct current stimulation non-invasive brain stimulation electroencephalography long covid
improving care after inherited cancer testing

Conditions: Inherited Cancer Syndrome; Prostate Cancer; Colorectal Cancer; Endometrial Cancer; Breast Cancer

Summary: the impact study seeks to refine and evaluate the effectiveness of interventions on improving guideline-adherent cancer risk management (crm) and family communication (fc) of genetic test results for individuals with a documented pathogenic/likely pathogenic (p/lp) variant, and fc of family cancer history for individuals with a variant of uncertain significance (vus) in an inherited cancer gene.

through recruitment of a racially, geographically, and socioeconomically diverse sample of patients, we will achieve the following aims: 1. evaluate factors associated with access to genetic risk assessment, counseling, and testing services. 2. conduct a randomized controlled trial to assess the effectiveness of interventions on improving guideline-adherent crm and fc of genetic test results among individuals with a p/lp variant in an inherited cancer gene. 3. conduct a pilot study to assess the effectiveness of an intervention on improving fc of family cancer history among individuals with a vus in an inherited cancer gene. 4. create and pilot an adaptive intervention to tailor resources to promote crm and fc. 5. document and compare multiple implementation outcomes across the different interventions to maximize their effectiveness and improve reach to underserved populations.

Eligibility criteria:
randomized controlled trial eligibility: all trial participants will be autonomous adults who are capable of participating in the study inclusion criteria: * english-speaking men and women aged 18 years or older * not adopted (i.e., have information about their biological relatives) * have access to internet and a computer, tablet, or smartphone * documented pathogenic/likely pathogenic variant in an inherited cancer gene that has crm guidelines listed in the national comprehensive cancer network (nccn) genetic/familial panel focused on breast, ovarian, and pancreatic or colorectal cancers * must meet at least one of the following criteria: * intervention a (geneshare) criteria: have at least one at-risk adult, living relative who either: * has not been told about the genetic test result by the participant * has not had their own genetic testing * intervention b (livinglabreport) criteria: are non-adherent (i.e., either undertreatment or overtreatment) to at least one of the current nccn crm guidelines or if currently adherent, require ongoing cancer screening vus pilot study eligibility: all vus pilot study participants will be autonomous adults who are capable of participating in the study. eligibility criteria include: * english-speaking men and women aged 18 years or older * not adopted (i.e., have information about their biological relatives) * have access to internet and a computer, tablet, or smartphone * documented vus in an inherited cancer gene

Keywords: inherited cancer gene pathogenic/likely pathogenic variant variant of uncertain significance cancer risk management family sharing
study evaluating safety and adherence to treatment with etanercept in adults with psoriatic arthritis

Conditions: Arthritis, Psoriatic

Summary: the aim of this study is to evaluate if the data obtained in controlled clinical trials are confirmed when enbrel is used in usual clinical practice in belgium according to local reimbursement criteria.


Eligibility criteria:
inclusion criteria: * active erosive psoriatic arthritis of poly-articular type or active erosive or with joint space narrowing psoriatic arthritis of oligo-articular type * at least 18 years old * have fulfilled reimbursement criteria for enbrel in psoriatic arthritis of poly-articular type or oligo-articular type * physician decides to prescribe enbrel or patient is already on enbrel * give written informed consent at time of inclusion to study exclusion criteria: na

Keywords: postmarketing surveillance enbrel psoriatic arthritis
fitting evaluation of hydrogel and silicone hydrogel spherical contact lenses

Conditions: Myopia

Summary: this study aims to compare the short-term clinical performance of the three contact lenses (methafilcon a iv, ocufilcon b 1-day and omafilcon a 1-day daily disposable).

this will be a randomized, double-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. forty subjects will wear each lens brand for approximately one hour, on three separate study days in random order. lenses will only be worn during study visits.

Eligibility criteria:
inclusion criteria: * they are of aged 18-40 and have capacity to volunteer. * they understand their rights as a research subject and are willing and able to sign a statement of informed consent. * they are willing and able to follow the protocol. * they agree not to participate in other clinical research for the duration of this study. * they have a contact lens spherical prescription between -1.00 to - 6.00d (inclusive) * they have a spectacle cylindrical correction of -0.75d or less in each eye (based on the ocular refraction). * they can attain at least 0.10 logmar distance high contrast visual acuity in each eye with the study lenses within the available power range. * they currently use soft contact lenses or have done so in the previous six months. exclusion criteria: * they have an ocular disorder which would normally contra-indicate contact lens wear. * they have a systemic disorder which would normally contra-indicate contact lens wear. * they are using any topical medication such as eye drops or ointment. * they have had cataract surgery. * they have had corneal refractive surgery. * they have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. * they are pregnant or lactating. * they have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. * they have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. hiv), or a history of anaphylaxis or severe allergic reaction. * they have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
study of modified atkins diet in kabuki syndrome

Conditions: Kabuki Syndrome

Summary: animal models of kabuki syndrome have showed a reversal of the cognitive phenotype with ketogenic diet. modified atkins diet is safer and easier tolerated than full ketogenic diet and still has the histone deacetylase inhibition believed to be responsible for the cognitive improvement. this study aims to examine a small number of adults with kabuki syndrome before and after 12 weeks on a modified atkins diet to determine if there is any cognitive improvement and if the diet can be tolerated.

consented participants will participate in an initial 2 day study visit. these participants will undergo cognitive and neurobehavioral testing and also will have baseline labs drawn and will meet with a johns hopkins nutritionist trained in modified atkins diet for education. the labs are standard of care for diet initiation to rule out contraindications to the diet. participants and/or their caregivers will keep a daily diet log and will be asked to download the free carb manager application onto their smartphone. they will send the logs and data back weekly. participants will be given urine ketone strips and asked to use and record in their diet log twice weekly. participants will have blood and urine samples collected locally every 3 weeks and sent back to study team to measure beta-hydroxybutyrate, metabolic studies and methylation. participants will return to baltimore at the end of 12 weeks for a one day visit to repeat the cognitive assessment protocol, neurobehavioral measures, and repeat the initial and follow up lab tests.

Eligibility criteria:
inclusion criteria:we will recruit 15 total participants with clinically-definite and genetically-confirmed kabuki syndrome type 1 age 18 years and older. . will also be required. * clinical diagnosis of ks will be made based on recently published consensus diagnosis criteria * genetic confirmation of a pathogenic mutation in kmt2d exclusion criteria: * presence of another known genetic syndrome * a health problem that would make a modified atkins diet harmful * inability to travel to baltimore for 2 visits separated by 12 weeks
ranibizumab treatment of diabetic macular oedema with bimonthly monitoring after a phase of initial treatment

Conditions: Diabetic Retinopathy; Macular Oedema

Summary: this study evaluates a new investigational treatment regimen of three consecutive monthly doses of ranibizumab followed by an as-needed treatment regimen, with monthly follow-up for the first three months then two-monthly follow-up until 18 months in patients with visual impairment due to diabetic macular oedema.the aim of the study is to determine if this treatment regimen is effective and safe in these patients.


Eligibility criteria:
inclusion criteria: * patients with type 1 or type 2 diabetes mellitus. * patients with visual impairment due to focal or diffuse diabetic macular oedema (dmo), and not other causes, in at least one eye who are eligible for laser treatment in the opinion of the investigator. * best corrected visual acuity between 78 and 24 letters in the study eye using early treatment diabetic retinopathy study (etdrs)-like grading charts (approximate snellen equivalent of 20/32 to 20/320). * increased central retinal thickness which, in the opinion of the investigator, is due to dmo. exclusion criteria: * concomitant conditions in the study eye that could prevent the improvement of visual acuity on study treatment. * active intraocular inflammation (grade trace or above) or infection in either eye at enrollment. * history of uveitis in either eye at any time. * structural damage within 0.5 disc diameters of the centre of the macular in the study eye likely to preclude improvement in visual acuity following resolution of macular oedema. * planned medical or surgical intervention during the 18-month study period. * uncontrolled glaucoma in either eye at screening. * blood pressure systolic \> 160 mmhg or diastolic \> 100 mmhg at screening. * ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids. * history of acute thromboembolic event within 4 months of screening. * untreated diabetes mellitus. * evidence of advanced, severe or unstable concomitant disease or its treatment which may interfere with evaluations or put the patient at special risk. other protocol-defined inclusion/exclusion criteria may apply

Keywords: diabetes mellitus diabetic retinopathy macular oedema visual acuity
assessment of effectiveness and safety of dysport® for the treatment of hemifacial spasm

Conditions: Hemifacial Spasm

Summary: to compare the effectiveness and safety of dysport® with the domestic botulinum toxin type a (manufactured by lanzhou biologic product institute, p.r. china) for the treatment of hemifacial spasm.


Eligibility criteria:
inclusion criteria: * patient suffering from hemifacial spasm with at least 6 months duration (prior to visit 1) * cohen scale ≥ to grade ii exclusion criteria: * botulinum toxin type a treatment history within last 16 weeks prior to visit 1 * hemifacial spasm secondary to facial palsy * previous alcohol or phenol injections or surgical therapy of the facial muscles * requirement for botulinum toxin injection to site(s) of the body other than in this study
mk0354 clinical efficacy and tolerability study (0354-004)

Conditions: Dyslipidemia

Summary: a research study to evaluate the effectiveness and tolerability of mk0354 vs placebo (an inactive look alike pill) in lipid (fat) altering in patients with dyslipidemia (a disorder of lipids in the blood) this is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (full information is available to trial participants).


Eligibility criteria:
inclusion criteria: * patient is between 18 and 75 years of age * you have taken a statin or other lipid modifying therapy in the last 6-8 weeks * you have lipid lab values outside of the range specified in the protocol exclusion criteria: * patient is a woman who is pregnant or nursing a child * patient is a woman who is taking hormonal birth-control * you are a woman who is planning to donate eggs during the study * you plan to give blood during the study or have given within the last 8 weeks * you are a woman who is having menopausal hot flashes or are taking medications to prevent menopausal hot flashes * you have a known intolerance to or you are allergic to niacin * you have any of the following medical conditions: * poorly controlled or newly diagnosed diabetes (within the last 3 months) * thyroid disease (hypothyroidism or hyperthyroidism) * a history of stroke, heart attack, coronary bypass surgery, angioplasty, unstable angina or similar heart and artery procedures in the past 3 months * history of hemorrhagic stroke or other non-traumatic hemorrhage * peptic ulcer disease in the last 3 months * an occurrence of gout within the last year and you are not currently taking allopurinol * cancer (except for successfully treated skin cancer) * hiv positive * you have a history of drug/alcohol abuse within the last year * you consume more than 2 drinks of alcohol per day * you do not have access to a telephone * you take medications that are not allowed in this study. the study doctor or staff will discuss this with you. * patient has participated in a study with an investigational drug within the last 30 days