Kornimate/medical-research-clean huggingface dataset:
prevention of vitamin d deficiency

Conditions: Vitamin D Deficiency

Summary: breastfed infants living in a northern location (41 degrees n) are at high risk of vitamin d deficiency during winter. this trial is designed to determine how much supplemental vitamin d breastfed infants need to receive in order to remain free of vitamin d deficiency

it is increasingly being recognized that infants and children living at northern latitudes are at risk of vitamin d deficiency, especially if their skin is darkly pigmented. the study by the pi (pediatrics 2006;118:603) was the first to demonstrate that infants with light skin pigmentation living at 41 degrees north are at risk of vitamin d deficiency. during winter (december - april) a full 78% of infants were vitamin d deficient if they did not receive vitamin d from an external source. very few breastfed babies are currently receiving supplemental vitamin d. the recommended dose is 200 iu/day. however, there are questions about the adequacy of this dose of vitamin d for the prevention of vitamin d deficiency. the present trial is designed to determine whether a dose of 200 iu/day is effective or whether doses of 400 iu/day, 600 iu/day or 800 iu/day are required to prevent vitamin d deficiency reliably. the trial is a randomized, prospective double-blind trial in which breastfed infants will receive 200 iu/day or 400 iu/day or 600 iu/day or 800 iu/day from 1 to 9 months of age. there will not be a placebo control group. infants will be followed through 12 months of age. normal term infants (birth weight \>2500 g) who are born in june through november will be enrolled and randomized at 1 month of age. they will visit the study center at monthly intervals and will have capillary blood drawn at select ages. at 2 months and again in march or april whole body mineral content will be determined by dexa. infants will not be permitted to receive formula until 9 months of age. they may receive complementary foods beginning at 4 months of age. vitamin d supplements will be weighed before dispensing and again when the empty and half-empty containers are returned. study endpoints will be blood parameters and bone mineral content determined at the end of winter, i.e., between march and may 15. blood parameters include 25-ohd, parathyroid hormone, calcium, alkaline phosphatase, osteocalcin, n-telopeptide, ferritin and transferrin receptor. 180 infants will be enrolled at 1 month of age in the expectation that 48 per group will complete the trial to at least 9 months of age.

Eligibility criteria:
inclusion criteria: * term infant * no major congenital malformations * less than one month old * breastfed, no other foods exclusion criteria: * formula feeding * premature birth

Keywords: vitamin d deficiency breastfed infant northern latitude infant breastfed winter vitamin d status
effectiveness of the justice diversion halt-intervention

Conditions: Criminal Recidivism; Delinquency; Antisocial Behavior

Summary: in the current study the effectiveness of the dutch diversion measure halt is investigated using a randomized controlled trial. because of the thorough scientific substantiation of the intervention theory, it is hypothesized that receiving the halt-intervention will lead to less recidivism in comparison to receiving no intervention.

the halt-intervention is a widely used dutch diversion measure for youth (aged 12-17) who committed a minor offence. in the current study, it will be investigated whether the halt-intervention is successful in reducing recidivism and in achieving the intervention goals. the effectiveness will be assessed using a randomized controlled trial. participants will be randomly assigned to the experimental condition in which participants will receive the halt intervention or to the control condition in which participants will not receive an intervention. participants fill out three self-reported questionnaires over a time period of one year. with these questionnaires is it investigated whether the intervention is successful in achieving the different intervention goals (improving social skills, taking responsibility, correct wrongdoing or damage, improving conventional beliefs and improving support from the social network) and in achieving a reduction in recidivism. furthermore, the adherence to children's rights in the practice of halt is investigated. lastly, two years after the first contact with halt recidivism is assessed using official police and judicial records.

Eligibility criteria:
inclusion criteria: * juveniles who have been referred to halt after committing a minor offence that is eligible for the halt-intervention. * juveniles between the ages of 12 and 18. exclusion criteria: * participants who do not speak dutch or who do not speak dutch fluently. * participants who have already participated in the study before. * participants who are participating in the following halt-programs: 'hack_right', 'respect online' or 'sport en spel'. * participants of whom it is suspected that their are serious concerns for their safety.
effect of medical cannabis for non-motor symptoms of parkinson's disease

Conditions: Bladder, Overactive; Parkinson Disease

Summary: medical cannabis (mc) is a standard treatment in israel to parkinson's disease (pd) patients suffering from pain. nevertheless, it is not known about mc effectiveness for other non-motor symptoms of the disease. our aim is to prospectively observe patients with pd before and after initiation of mc, for non-motor symptoms effect. in specific, relying of data from multiple sclerosis patients and basic science showing cannabinoid receptor 1 (cb1) is abundantly expressed in the sub epithelial layer of the bladder, we will explore the impact of mc on bladder function and urinary symptoms.

this is a prospective, open-label, observational study. patients with parkinson's disease (pd) receiving licensure from israeli ministry of health (moh) for using medical cannabis (mc) for pd related symptoms and pain, being followed up in the movement disorders institute (mdi) at sheba medical center (smc) will be eligible to participate. assessment regarding patient demographic, disease characteristics (hoehn and yahr, disease duration, disease first symptom etc.) will be collected at baseline along with designated questionnaires to evaluate the non-motor symptoms (nmss, pdss, kings pd pain scale, pdq8) and urinary function (bladder over activity, international prostate symptom score (ipss) and nocturia questionnaires). after mc initiation, patients will be observed and evaluated for the impact of mc 4-8 weeks following treatment initiation. also, for each patient, mc being used will be analyzed in order to expose relationship between phyto-cannabinoid content and efficacy or side effects.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease according to uk parkinson's disease society barin bank clinical diagnostic criteria * holds a validated medical cannabis license, from israeli ministry of health * able to sign informed consent * age 18-80 exclusion criteria: * use of medical cannabis in the previous 30 days prior to study recruitment visit * concomitent severe co-morbidities able to influence outcomes such as spinal injury, cancer, dementia. * cannot sign informed consent

Keywords: non-motor symptoms parkinson's disease bladder overactivity medical cannabis cannabidiol delta-9-tetrahydrocannabinol pain
a study of abicipar pegol in japanese patients with neovascular age-related macular degeneration

Conditions: Macular Degeneration

Summary: this is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between japanese and non-japanese.


Eligibility criteria:
inclusion criteria: * ethnically japanese * diagnosis of wet age-related macular degeneration in at least 1 eye * best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye exclusion criteria: * hypersensitivity, allergy, or anaphylactic reaction to iodine or shellfish * cataract or refractive surgery within the last 3 months * history of vitrectomy
the closer trial: a safety and efficacy study of the rex medical vascular sealing system

Conditions: Surgical Wound

Summary: the objective of this trial is to demonstrate the safety and effectiveness of the rex medical closer vascular sealing system in sealing femoral arterial access sites.

the objective of the trial is to demonstrate the safety and effectiveness of the rex medical closer vascular sealing system (vss) in sealing femoral arterial access sites and providing reduced times to hemostasis (tth) compared with performance goals at the completion of diagnostic or interventional procedures performed through 5, 6 or 7 fr procedural sheaths. this study will be considered a success (from a statistical perspective) if it meets both the closer vss superiority goal for the primary effectiveness analysis and the closer vss performance goal for the primary safety analysis.

Eligibility criteria:
inclusion criteria: pre-op inclusion criteria: 1 - acceptable candidates for an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 5, 6, or 7 fr introducer sheath. - exclusion criteria: pre-operative exclusion criteria: 1. - significant bleeding diatheses or coagulopathy 2. - planned endovascular or surgical procedures within next 30 days 3. - planned ipsilateral femoral arteriotomy within next 90 days 4. - arteriotomy in ipsilateral groin within the past 30 days with any residual hematoma, significant bruising or vascular complication 5. - previous vessel closure device used in ipsilateral groin within the past 90 days 6. - previous vascular surgery or repair in the vicinity of the target access site 7. - severe peripheral vascular disease in the ipsilateral limb requiring surgical or endovascular treatment within the pervious 30 days or next 30 days 8. - existing nerve damage in ipsilateral limb 9. - extreme morbid obesity (bmi \> 4 kg/m2) intra-operative exclusion criteria: 10. - use of a procedural sheath that is \ 7 fr 11. - difficult insertion of procedural sheath or needle stick problems at the onset of the procedure 12. - placement of an ipsilateral venous sheath for procedure 13. - procedural sheath placement either through the superficial femoral artery and into the profunda femoris artery, or placement at or distal to bifurcation of the superficial femoral artery and the profunda femoris artery 14. - in subjects receiving unfractionated heparin, an act \> 350 seconds, or \> 250 seconds in the presence of a gp iib/iiia inhibitor 15. - procedures or existing medical conditions that may extend index hospitalization beyond 24 hours post-procedure 16. - systemic hypertension (sbp \> 180 mmhg) or hypotension (sbp \< 90 mmhg) just prior to enrollment

Keywords: arteriotomy vessel closure femoral access site
repetitive transcranial magnetic stimulation compared or associated with venlafaxine for depressive disorder

Conditions: Depression

Summary: the purpose of this study is to treat participants with a diagnosis of depressive disorder to assess the efficacy of repetitive transcranial magnetic stimulation (rtms) and venlafaxine in the treatment of depressive disorders compared venlafaxine only (the optimal medication) and to rtms only. fmri will be performed to determine if treatment response is related to changes in fmri, and use it to investigate the respondence to the treatments.


Eligibility criteria:
inclusion criteria: * 18 years and older * clinical diagnosis of major depressive disorder (dsm-iv) * hdrs-17 items \> 20 * failure of one antidepressant treatment (efficacious doses for 6 weeks at least) exclusion criteria: * psychotic features * failure of one previous venlafaxine treatment * addiction comorbidity or schizophrenia comorbidity * involuntary hospitalization * seizures history * pregnancy or breastfeeding * somatic comorbidity able to impact on cognitive functions

Keywords: repetitive transcranial magnetic stimulation (rtms) depression venlafaxine fmri
18fluoroldopa pet imaging for the detection and localization of focal congenital hyperinsulinism

Conditions: Congenital Hyperinsulinism

Summary: the goal of this project is to determine the role of fdopa/pet as a pre-operative diagnostic imaging procedure for differentiating focal and diffuse forms of congenital hyperinsulinism and locating focal lesions in the pancreas to guide surgical resection.

congenital hyperinsulinism (hi) is the most common cause of recurrent and persistent hypoglycemia, presenting early in infancy. patients who fail medical therapy usually require resection of the diseased pancreas(partial or subtotal pancreatectomy) to control this disorder. over half of patients undergoing surgery have a focal area of islet cell dysfunction that is curable with resection. these focal lesions are areas of adenomatosis consisting of a clone of beta-cells that express a paternally-derived mutation of the katp channel due to loss of heterozygosity for the maternal allele. current imaging techniques cannot differentiate focal and diffuse forms of hyperinsulinism, nor can they locate focal areas of disease within the pancreas before surgery. l-dopa is taken up by some neuroendocrine cells, including pancreatic islet cells, and stored as dopamine in secretory granules. recent studies show that positron emission tomography (pet) following administration of 18f-fluoro-l-dopa (fdopa) can distinguish focal and diffuse forms of hi and accurately locate focal lesions within the pancreas.

Eligibility criteria:
inclusion criteria: * any age, but primarily infants 0-6 months given typical age of initial presentation. * children with diagnosis of fohi or dihi based on clinical criteria (fasting hypoglycemia accompanied by inadequate suppression of plasma insulin, inappropriately low plasma free fatty acid and plasma-hydroxybutyrate concentrations, and an inappropriate glycemic response to glucagon injection) o confirmed by genetic testing for mutations in abcc8 and kcnj1 was1. * hypoglycemia uncontrolled with medical management (diazoxide, octreotide). * able to withdraw medications in time to wash out prior to the scheduled pet scan. * patients fulfilling criteria above but with uncontrolled hypoglycemia after initial surgical management (partial or near-total pancreatectomy) * normal hepatic and renal function. exclusion criteria: * treatment with other, third-line, medications for hyperinsulinism (nifedipine, glucagon). * patients with hepatic or renal insufficiency.
study of ljp 394 in lupus patients with history of renal disease

Conditions: Lupus Erythematosus, Systemic; Lupus Nephritis

Summary: the primary purpose of this study is to determine whether abetimus sodium is more effective than placebo in delaying time to renal flare in sle patients with a history of renal disease.


Eligibility criteria:
inclusion criteria: * diagnosis of systemic lupus erythematosus (sle) * active sle renal disease within past 4 years. * males or females between 12 and 70 years old. * females must be non-pregnant and non-lactating. females and males must use adequate birth control methods during course of study. * ability to have weekly intravenous (iv) administration of study treatment. exclusion criteria: * active sle renal disease within past 3 months prior to entering study. * use of the following therapies within 3 months prior to entering the study: alkylating agents, e.g., cyclophosphamide, tnf inhibitors, cyclosporine. * use of mycophenolate mofetil that exceeds 1000 mg/day, azathioprine that exceeds 100 mg/day, methotrexate that exceeds 10 mg/week, leflunomide that exceeds 10 mg/day within 2 months prior to entering study. * use of rituximab within 6 months prior to entering study. * current abuse of drugs or alcohol.

Keywords: lupus nephritis kidney sle systemic lupus erythematosus nephritis, lupus
indomethacin eyedrops compared with ketorolac eyedrops for ocular inflammation following cataract surgery

Conditions: Cataract; Inflammation

Summary: this study is being conducted to show that indomethacin is at least as effective as ketorolac for the prevention of ocular inflammation following cataract surgery.


Eligibility criteria:
inclusion criteria: * subjects must be planning to undergo cataract surgery on one eye by phacoemulsification with posterior chamber intraocular lens, using topical or general anaesthesia. * subjects must have a preoperative flare ≤ 15 ph/ms, measured with a laser flare meter(lfm) without pharmacological pupil dilation, within the 2 months preoperatively. exclusion criteria: * subjects who have any progressive pathology requiring the use of topical or systemic anti-inflammatory or anti-infectious agents. * subjects who take acetylsalicylic acid at doses \> 100 mg daily and cannot discontinue usage during the study. * subjects who have a history of asthma linked to acetylsalicylic acid or other nonsteroidal anti-inflammatory (nsai) drug administration. * subjects with immunodepression. * subjects with a history of intolerance to the study drug or to any nsai drug. * subjects who are monocular for any reason other than cataract. * subjects who are treated with local or systemic anti-inflammatory drugs within 10 days prior to inclusion.
a comparison of outcomes after anterior cruciate ligament (acl) or anterior cruciate ligament and meniscus (acl+meniscus) surgery using semiconductor fabric products

Conditions: ACL Reconstruction; Meniscus Tears; Anterior Cruciate Ligament Rupture

Summary: the goal of this clinical trial is to determine the effect of semiconductor sleeves on the treatment of anterior cruciate ligament (acl) or anterior cruciate ligament and meniscus (acl+meniscus) arthroscopic surgery. the effect of the sleeves will be analyzed through patient reported and clinically measured outcomes. the main questions it aims to answer are: * do the semiconductor sleeves improve the functional outcomes compared to the placebo? * will patients experience improved functional outcomes in a shorter period of time compared to the placebo? researchers will compare semiconductor fabric sleeves to a placebo (a look-alike sleeve that contains no semiconductor material) to see if the semiconductor fabric better treats acl and acl+meniscus surgical patients. participants will: * wear semiconductor or placebo leg sleeve for 4 weeks and knee sleeve for the following 12 weeks * complete patient reported outcome surveys


Eligibility criteria:
inclusion criteria: * patients undergoing acl or acl+meniscus surgery * age 16 - 65 * patients with body mass index (bmi) \<40 * patients who are willing and able to adhere to follow-up schedule and protocol guidelines. * patients who are willing and able to sign corresponding research subject consent/assent form. exclusion criteria: * patient has a history of neurological conditions, including multiple sclerosis or parkinson's disease * patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia * patient has had prior surgical treatment of the knee in the last 5 years or injection treatment(s) in the last 6 months * patient has chronic pain conditions unrelated to knee condition * patient has auto-immune or auto-inflammatory diseases * patient has poorly controlled diabetes (hga1c \> 7.5) * patient has bmi \> 39.9 * patient has varicosities on the operative leg * patient has severe peripheral artery disease (abi \< 0.6) * patient is considered a pain management patient * patient has had previous blood clots or stroke * patient has used tobacco within the last 90 days * patient is not within the ages of 16-65 * patient has an active infection (local or systemic), or an open (non-surgical) wound in the areas of product application * patient is unwilling or unable to sign the corresponding research subject consent/assent form * patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results.

Keywords: acl meniscus tear acl tear compression sleeve semiconductor fabric acl reconstruction
preoperative boost associated with neoadjuvant chemotherapy in luminal b breast cancer

Conditions: Breast Cancer; Radiotherapy

Summary: ibisco trial is a phase ii trial aimed to demonstrate the improvement of pathological complete response (pcr) in luminal b breast cancer (bc) patients treated with stereotactic radiation therapy (sbrt) as an anticipated boost associated with neoadjuvant chemotherapy (nac). as a secondary objective, histochemical and molecular analysis of the tumour and the inflammatory microenvironment will be performed.

ibisco trial is a phase ii trial aimed to demonstrate the improvement of pcr in luminal b breast cancer (bc) patients treated with stereotactic radiation therapy (sbrt) as an anticipated boost associated with neoadjuvant chemotherapy (nac). the primary endpoint will be evaluated on surgical specimen using the residual cancer burden (rcb) index. thirty patients with clinical stage t1-2 luminal b bc, suitable for conservative surgery and with a clinical indication for nac, will be enrolled in two years. an observation cohort will also be created with patients fulfilling inclusion criteria who refuse enrollment in the interventional cohort and for patients where sbrt boost appears not feasible after enrollment for technical issues. as a secondary objective, histochemical and molecular analysis of the tumour and the inflammatory microenvironment will be performed. after the completion of neoadjuvant treatments, surgery and adjuvant therapies (endocrine therapy and whole breast irradiation) will be performed as for clinical practice

Eligibility criteria:
inclusion criteria: * luminal b-like bc, ct1-2 * indication for neoadjuvant chemotherapy exclusion criteria: * pregnancy * breast feeding * patient not available for follow up

Keywords: luminal b breast cancer neoadjuvant radiation therapy neoadjuvant chemotherapy
understanding and treating heart failure with preserved ejection fraction: novel mechanisms, diagnostics and potential therapeutics

Conditions: Heart Failure

Summary: the objectives of this study are: 1) to design new diagnostic criteria used to accurately define heart failure with preserved ejection fraction (hfpef); 2) to better define the risk factors associated with hfpef; 3) to elucidate the clinical, cellular and molecular mechanisms involved with the development and progression of hfpef; 4) to design and test new therapeutic strategies for patients with hfpef.


Eligibility criteria:
inclusion criteria: * group 1 no clinically overt heart failure * group 2 known coronary artery disease * group 3 known heart failure with preserved ejection fraction * group 4 known heart failure with reduced ejection fraction * group 5 healthy age-matched controls exclusion criteria: * age \<18 years * known malignancy with expected survival \<1 year * pregnant or recent pregnancy \<6 months * recent event (\<2 weeks since acute coronary syndrome, heart failure or other admission * severe mitral or aortic stenosis