Kornimate/medical-research-clean huggingface dataset:
a trial evaluating vitamin d normalization on major adverse cardiovascular-related events among myocardial infarction patients

Conditions: Death; Myocardial Infarction; Cerebral Vascular Accident; Heart Failure Hospitalization

Summary: this study evaluates whether achieving 25-hydroxyvitamin d (25\[oh\] vit d) levels (\>40 ng/ml) among myocardial infarction patients will result in a reduction of cardiovascular-related adverse events. half of the patients will be randomized to receive standard of care and half will receive clinical management of 25\[oh\] vit d levels.

low 25\[oh\] vit d levels have become a public epidemic with increasing recognition of its widespread insufficiency both in the united states and worldwide. epidemiologic studies have associated low 25\[oh\] vit d levels with coronary risk factors and adverse cardiovascular outcomes. however, randomized trials are needed to establish the relevance of 25\[oh\] vit d status to cardiovascular health. while a few randomized trials have evaluated vitamin d supplementation, none have "treated to target" (i.e., individual dosing so that adequate 25\[oh\] vit d levels are obtained), but have rather given "blanket" doses regardless of 25\[oh\] vit d level.

Eligibility criteria:
inclusion criteria: 1. patients, both male and female, \>18 years old 2. undergone angiography for a mi (troponin positive \[\>0.04 ng/ml\] and acs diagnosis) within the past month 3. receive follow-up care at an intermountain healthcare facility 4. not taking or taking \<1000 iu of vitamin d daily within the last 3 months 5. willing to provide informed consent and participate in follow-up visits exclusion criteria: 1. hypersensitivity to vitamin d products 2. history of previous vitamin d supplementation of \>1000 iu daily within the past 3 months (i.e., \>40% of the days during the past 3 months). 3. systemic disease (including terminal cancer, cirrhosis, end stage copd, etc) with a reduced (\<12 months) life expectancy 4. hypercalcemia (calcium levels \>10.6 mg/dl) 5. subject participation in previous investigational interventional studies within 30 days of the current study. 6. history of psychiatric illness/condition that would interfere with their ability to understand or complete the requirements of the study, a condition that in the opinion of the investigator or their designee places the subject at an unacceptable risk as a participant. 7. pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception as determined by the clinical investigators.
a study investigating whether low dose eyedrops for pupil dilation is as effective and safe as standard dose eyedrops in examination for retinopathy of prematurity.

Conditions: Retinopathy of Prematurity

Summary: a prospective, randomized controlled study was conducted from august, 2022 to march, 2023 in the neonatal intensive care unit in queen mary hospital, hong kong. the aim of this study was to determine whether microdrops mydrin-p demonstrates similar efficacy as standard mydrin -p eyedrops applied to neonates undergoing retinopathy of prematurity (rop) screening exams, also to ascertain the optimal time for eye examination after administration of mydriatics and assess whether the cardiovascular, respiratory and gastrointestinal adverse effects differ between microdrops and standard dose mydrin-p. preterm infants were randomized to receive either the standard mydrin-p eyedrops or the mydriatic microdrops which contained around one-third of the standard mydrin-p dosage. the primary outcome measured whether a successful rop examination was conducted. secondary outcomes included pupil diameters at baselines, 30 minutes, 60 minutes, 120 minutes after eyedrops instillation and at the time of rop exam as well as adverse effects followed by the mydriatics administration. a total of 18 patients were enrolled in this study with total 46 episodes of rop recorded. all episodes with microdrops instillation led to successful rop exams. there was no statistically significant difference between standard eyedrops and microdrops in determining the success of rop exam (p=0.233). mean pupil diameter did not differ between the microdrops and standard eyedrops group. at the time of rop exam, the mean pupil diameter was 5.47mm in the standard eyedrops group and 5.73mm in the microdrops group. the optimal time for rop exam was 60 minutes to 120 minutes after first dose of mydriatic. also there was no difference in the occurrence of systemic side effects when compared to standard mydrin p drops. hence the study concluded that microdrops have similar efficacy and safety profile compared to standard mydrin-p eyedrops.


Eligibility criteria:
inclusion criteria: * neonates with estimated gestational age (ega) at birth ≤32 weeks * neonates with birth weight ≤1500g exclusion criteria: * neonates with severe clinical condition with unstable vital signs * neonates with congenital anomalies, syndromic disease * neonates with ophthalmological conditions such as eye infections, congenital eye anomalies, trauma * neonates with conditions that are contraindicated to mydriatic use

Keywords: retinopathy of prematurity preterm retinopathy of prematurity screening microdrops mydrin p mydriatics
a-botulinic toxin for symptomatic benign prostate hypertrophy

Conditions: Prostatic Hyperplasia

Summary: bph is very common in elderly men, it is a stromal as well as epithelial invasion of the prostatic gland. due to an imbalance between growth and apoptosis cellular mechanisms that are not fully elucidated. it is the same for symptomatology and urodynamic obstruction without clear identification of the part which is due to static phenomena (volume increase) and dynamic reports (α 1-receptor action). that explains the multiplicity of treatments and the difficulty of therapeutic indications between monitoring, medical treatment, and surgical operation. experimental studies of bont-a intra prostatic injection on animal and human models, have shown efficacy in bph cell apoptosis, decrease in cell growth and decline in the number of adrenergic α1 receptors. many studies in humans show therapeutic efficacy leading to a possible use of bont-a as mini invasive treatment of symptomatic bph, as an alternative to medical or surgical treatment. protox study proposes to evaluate tolerance and effectiveness of the intra-prostatique bont-a injection in the treatment of symptomatic bph.


Eligibility criteria:
inclusion criteria: * patient aged 50 to 85; * obstructive or irritative urinary symptomatology linked to a bph; * score ipss moderate to severe (8-19: moderate; 20-35: severe) or ipss ≤ 7 in patient medically treated for symptomatic bph; * increase in prostate volume on the rectal touch or ultrasound; * free consent, informed and written, dated and signed by the patient and the investigator (at the latest the day inclusion and before any examination requires the study); * subject affiliate or beneficiary of a social protection exclusion criteria: * stenosis of the urethra confirmed by endoscopic or radiological examination; * prostate cancer suspicion; * medical past history of surgery, radiotherapy or pelvic trauma (, breach of the urethra, pubic symphysis disjunction); * surgical resection of the prostate (adenomecty); * clinical or paraclinical signs of vesical sphincterial disynergia; chronic urinary retention \> 500 ml; * bph complications making surgery necessary: effects on the upper urinary tract: dilatation or renal obstructive insufficiency, bladder stones or diverticula. * patient previously treated by botulic toxin (whatever injection site); * persons unable to understand the course of the study.
treatment of severe male infertility - predictive factors (imaging)

Conditions: Male Infertility

Summary: testes of men with non-obstructive azoospermia (noa) are imaged using mri to find potential differences depending on the outcome, ie. sperm recovery in consequent microdissection testicular sperm extraction (md-tese).

sperm recovery rate in non-obstructive azoospermia (noa) men is 43% in turku university hospital, depending on the diagnosis leading to noa. to date, there are no known parameters known to differentiate between successful and unsuccessful sperm recovery. mri is performed on men prior to the operation, and the objective is to compare the functional parameters assessed by magnetic resonance imaging between the group of men with positive and the men with negative sperm recovery in testicular microdissection sperm extraction (md-tese).

Eligibility criteria:
inclusion criteria: * non obstructive azospermia exclusion criteria: * malignancy * contraindication for fertility treatment

Keywords: azospermia micro dissection testicular sperm extraction male infertility testis mri
reducing children's distress towards flu vaccinations

Conditions: Children's Distress During Flu Vaccination

Summary: millions of children in north america receive an annual flu vaccination, many of whom are at risk of experiencing severe distress. children frequently use technologically advanced devices such as computers and cell phones. based on this familiarity, the investigators introduced another sophisticated device - a humanoid robot to- interact with children during their vaccination. the investigators hypothesized that these children would experience less distress than children who did not have this interaction.

57 children (30 male; age, mean + sd: 6.87 + 1.34 years) were randomly assigned to a vaccination session with a nurse who used standard administration procedures, or with a robot who was programmed to use cognitive-behavioral strategies with them while a nurse administered the vaccination. measures of distress were completed by children, parents, nurses, and researchers.

Eligibility criteria:
inclusion criteria: * ages 5-9 years, * boys and girls exclusion criteria: * children with pervasive developmental disability

Keywords: pain management vaccination immunization pediatric robotics human-robot interaction
non-pharmacological interventions on patient experience and healthcare utilization in adult cardiac surgery patients

Conditions: Cardiac Surgery

Summary: this study will assess whether non-pharmacological interventions by a comfort coach affect the amount of opioid pain medication used, as well as perceived physical pain and emotional anxiety and healthcare utilization for adult cardiac surgery patients. participants that are eligible for the study will be randomized to the comfort coach arm or standard of care. both groups will complete surveys at the specific time frames in order to compare their outcomes. the study hypothesis is that there will be a decrease in opioid use in the intervention group compared to the standard of care arm during the 90-day perioperative course, as well as a decrease in pain and anxiety along with a lower composite outcome of healthcare utilization.


Eligibility criteria:
inclusion criteria: * receiving a first-time elective status open heart cardiac surgery procedure in the frankel cardiovascular center at michigan medicine during the recruitment period through a full or miniature sternotomy incision * opioid-naïve, defined as not taking a home opioid medication at time of preoperative h\&p exclusion criteria: * patients undergoing cardiac transplantation, implantation of ventricular assist device, reoperation, and any planned use of circulatory arrest * chronic opioid users defined as taking an opioid at time of preoperative clinic visit * non-english speaking * inability to understand or complete surveys * pregnancy * unable to sign legal consent form (legal guardian signature not acceptable)

Keywords: surgery cardiac opioids anxiety
a novel mobile app & population management system to manage rheumatoid arthritis flares

Conditions: Arthritis; Rheumatoid Arthritis

Summary: the overall objective of this proposal is to implement a smart phone application (app) + population management system to monitor rheumatoid arthritis (ra) disease activity between scheduled physician office visits. the population management system includes: 1) a web-based dashboard that consolidates incoming patient-reported data using pre-programmed algorithms to identify increases in disease activity, and 2) the population manager, a trained individual who monitors the web-based dashboard and connects patients with their healthcare providers (hcps). the investigators central hypothesis is that the combined smart phone app + population management system will improve patient satisfaction and management of ra disease activity.


Eligibility criteria:
inclusion criteria: * diagnosis of ra by a board-certified rheumatologist * taking a dmard (sulfasalazine, methotrexate, leflunomide, azathioprine, certolizumab, cyclosporine, adalimumab, etanercept, infliximab, golimumab, abatacept, tocilizumab, anakinra, tofacitinib, rituximab, hydroxychloroquine) * own a smart phone with either an android or iphone operating system * be english-speaking exclusion criteria: * patients who do not plan on receiving follow-up care at the brigham and women's hospital arthritis center

Keywords: rheumatoid arthritis mobile health pain arthritis
targeted reversal of inflammation in pediatric sepsis-induced mods

Conditions: Pediatric Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS)

Summary: the trips study is a prospective, multi-center, double-blind, adaptively randomized, placebo-controlled clinical trial of the drug anakinra for reversal of moderate to severe hyperinflammation in children with sepsis-induced multiple organ dysfunction syndrome (mods).

the trips study is a prospective, multi-center, double-blind, adaptively randomized, placebo-controlled clinical trial of the drug anakinra for reversal of moderate to severe hyperinflammation in children with sepsis-induced multiple organ dysfunction syndrome (mods). eligible subjects will undergo centralized immunophenotyping on day 2 of mods. subjects without immunoparalysis (a whole blood ex vivo lps-induced tnf-alpha production capacity \< 200 pg/ml) and a serum ferritin level of 500 - 2,000 ng/ml or a serum c-reactive protein (crp) ≥ 4 mg/dl will be eligible for randomization, along with subjects with a serum ferritin level of 2,000 - 10,000 ng/ml regardless of their tnf-alpha response. eligible subjects will receive intravenous (iv) anakinra at a dose of 4, 8, 12, or 16 mg/kg/day or placebo for 7 days.

Eligibility criteria:
inclusion criteria: * ≥ 40 weeks corrected gestational age to \< 18 years; and * admission to the picu or cicu; and * onset of ≥ 2 new organ dysfunctions within the last 3 calendar days (compared to pre-sepsis baseline) as measured by the modified proulx criteria; and * documented or suspected infection as the mods inciting event. exclusion criteria: * weight \<3kg; or * limitation of care order at the time of screening; or * patients at high likelihood of progression to brain death in opinion of the clinical team; or * moribund condition in which the patient is unlikely to survive the next 48 hours in opinion of the clinical team; or * history of myeloid leukemia, myelodysplasia, or autoimmune thrombocytopenia; or * current or prior diagnosis of hemophagocytic lymphohistiocytosis or macrophage activation syndrome; or * peripheral white blood cell count \< 1,000 cells/mm3 as the result of myeloablative therapyor receipt of myeloablative therapy within the previous 14 days; or * known allergy to anakinra, or e. coli-derived products; or * known pregnancy; or * lactating females; or * receipt of anakinra or gm-csf within the previous 28 days; or * resolution of mods by mods day 2; or * previous enrollment in the trips study.
long-term safety and tolerability of affitope ad02

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the long-term tolerability and -safety of affitope ad02 applied during affiris 002


Eligibility criteria:
inclusion criteria: * written informed consent signed and dated by patient and caregiver * patients having participated in aff002 and having received at least 1 vaccination with affitope ad02 * availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits exclusion criteria: * patients having received no vaccination with affitope ad02 * history of questionable compliance to visit schedule, patients not expected to finish the clinical trial

Keywords: alzheimer morbus alzheimer vaccine alzheimer vaccine a-beta immunotherapy
a study of pegasys (peginterferon alfa-2a (40kd)) in patients with hbeag positive chronic hepatitis b.

Conditions: Hepatitis B, Chronic

Summary: this study will evaluate the efficacy and safety of pegasys (peginterferon alfa-2a) in patients with hbeag positive chronic hepatitis b. patients will be stratified into group a (treatment naïve patients) or b (ymdd mutant patients). all patients will receive pegasys 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.


Eligibility criteria:
inclusion criteria: * adult patients, 18-65 years of age * hbsag +ve for more than 6 months, hbeag +ve, antihbs -ve * detectable hepatitis b virus (hbv) dna (\>100,000 copies/ml) exclusion criteria: * coinfection with hepatitis a, hepatitis c or human immunodeficiency virus (hiv) * evidence of decompensated liver disease * a medical condition associated with chronic liver disease other than viral hepatitis
combined bone marrow and kidney transplant for multiple myeloma with kidney failure

Conditions: Kidney Failure, Chronic; Multiple Myeloma

Summary: the purpose of this study is to determine whether a combined bone marrow and kidney transplant will be effective in treating stage ii or greater multiple myeloma and associated kidney failure. this study will determine whether transplant rejection and the need for immunosuppressive drugs are decreased with this combined transplant approach.

in very limited human testing, a combined kidney and bone marrow transplant appears to be safe and effective in treating multiple myeloma and associated kidney failure. this study will evaluate this approach in 10 patients with kidney failure due to or in association with stage ii or greater multiple myeloma. treatment prior to transplant will include cyclophosphamide, atgam (a lymphocyte-specific immunosuppressant), local radiation to the thymus, and cyclosporine (an immunosuppressive drug). an infusion of donor bone marrow and a kidney graft from a closely matched, related donor will be transplanted simultaneously. an additional infusion of donor white blood cells may be administered between day 45 and 74 after transplant in an effort to eliminate any remaining cancer cells. patients will remain on cyclosporine for a defined period of time. the cyclosporine doses will be slowly decreased and stopped if graft rejection and graft-versus-host disease do not occur. each participant will be involved in the study for 3 years; this includes the intervention phase (time from initial screening at approximately 7 days before transplant through 100 days after the transplant) and continued follow-up visits for at least 2 years following the transplant.

Eligibility criteria:
inclusion criteria: * end-stage renal disease (esrd) due to or in association with stage ii or greater multiple myeloma * participants in whom the development of esrd is not due to the underlying myeloma will be included if they have evidence of active myeloma despite past treatment with standard therapies (e.g., prednisone, melphalan, high-dose radiation therapy with autologous stem cell transplantation) * on dialysis or have a creatinine clearance greater than 20 ml/min * hla-matched or one of six hla antigen-mismatched related donor exclusion criteria: * compromised pulmonary, cardiac, or liver function * active infection

Keywords: immune tolerance graft vs host disease kidney failure kidney diseases end stage renal disease multiple myeloma bone marrow transplant kidney transplant renal transplant tolerance chimerism esrd
impact of temporomandibular joint dysfunction on objective and subjective vocal measures

Conditions: Temporomandibular Joint Disorders; Voice Change

Summary: the present study aims to investigate the impact of temporomandibular joint dysfunction (tmd) on objective and subjective vocal parameters and the quality of life in affected patients. tmd is a pervasive public health issue that impacts approximately 25% of the general population and is notably more prevalent among women. the etiology of tmd is multi-factorial, with known risk factors such as parafunctional habits, emotional stress, occlusion issues, and orthodontic treatments. internal derangements of the temporomandibular joint are the most common subtype of tmd, characterized by symptoms such as pain, joint noises, restricted mouth opening, and masticatory dysfunction. this study particularly focuses on the limitations in mouth opening due to tmd and its effects on vocal characteristics and quality of life. conservative treatment methods, such as non-steroidal anti-inflammatory drugs (nsaids) and occlusal splints, have been effective in symptom management unless there is clear evidence of joint collapse or ankylosis. the null hypothesis (h0) posits that the restriction in mouth opening has no impact on vocal parameters or quality of life.


Eligibility criteria:
inclusion criteria: * individuals aged between 18 and 65 years. * capable of giving informed consent. * fluent in the local language for effective communication. * no history of hearing impairment or high communicative demands in their profession. * absence of a history of vocal disorders or conditions affecting voice quality. exclusion criteria: * individuals with a vocal disorder. * unable to provide informed consent or meet study requirements. * pregnant or lactating women. * presence of any medical condition that could potentially affect voice quality.