Kornimate/medical-research-clean huggingface dataset:
controlled trial of prenatal vitamin d3 supplementation to prevent vitamin d deficiency in mothers and their infants

Conditions: Vitamin D Deficiency

Summary: the purpose of this research study is to compare the effects of higher dose vitamin d with commonly recommended dose in pregnant women to see which is better in achieving and/or maintaining sufficient vitamin d blood levels during pregnancy and in newborn infants as well as improving growth in the infant.

three dosages of vitamin d will be administered; 400iu, 2000iu and 4000iu per day to pregnant women starting at less than 16 week gestation continued until delivery. the dose will be provided using a randomized control method. serum levels of 25 hydroxy d will be measured in mothers at 12, 16, 28 and delivery. cord blood 25 hydroxy d and the infants' birthweight, length and head circumference will be measured at birth.

Eligibility criteria:
inclusion criteria: * women who are within the ages of 18-45 years * in good general health * 12 weeks pregnant (based on last menstrual period) exclusion criteria: * mothers with preexisting type i or type ii diabetes * mothers with preexisting hypertension * mothers with preexisting parathyroid disease or uncontrolled thyroid disease * mothers with multiple fetuses (e.g., twins, triplets, etc.)
impact of family-centered empowerment on caregivers of children with cancer: a quasi-experimental study protocol

Conditions: Malignant Tumor

Summary: the purpose of this trial is to understand the impact of a family empowerment-based intervention program on family caregivers' readiness to care and ability to care. it aims to elucidate whether a health education intervention program based on the family empowerment model improves family caregivers' readiness for care and ability to care. participants will receive a health education program based on the family empowerment model and will complete questionnaires three days prior to admission, during hospitalization, and three days prior to discharge.this study is a non-pharmacological intervention and will not involve any changes in treatment or chemotherapy regimens.


Eligibility criteria:
inclusion criteria: (1) children aged 0-18 years old, (2) those clinically diagnosed with malignant neoplasms, and (3) first-time visitors to our hospital. primary caregiver inclusion criteria: the caregiver is enrolled along with the child, (1) was ≥18 years of age; (2) was a member of the child's immediate family; (3) had cared for the child for the longest period among multiple caregivers; (4) had basic communication and reading skills and was proficient in chinese; and (5) had no previous or current history of psychiatric illness or consciousness-related disorders. exclusion criteria: (1)children who abandon treatment or are transferred to a hospital while the study is in progress.
oscipulse d-dimer efficacy trial

Conditions: Venous Thromboses; Ischemic Stroke

Summary: the purpose of this study is to assess the safety and efficacy of the oscipulse system in reducing serum d-dimer levels in hospitalized ischemic stroke patients.

after being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. eligible and enrolled patients who have been admitted to the hospital for an ischemic stroke will be randomized in a non-blinded study to receive compression therapy from either standard-of-care intermittent compression garments, or the oscipulse system. during the duration of the subject's hospital stay serum d-dimer levels will be monitored serially.

Eligibility criteria:
inclusion criteria: 1. adult aged ≥ 18 years old 2. admitted to the neuro intensive care unit or intermediate neuro care unit with a diagnosis of ischemic stroke 3. last known normal \< 24 hours. 4. nih stroke score ≥5 5. weakness in at least one leg (≥ 1 point on the nihss lower extremity motor scores, items 6a and 6b) 6. prescribed mechanical therapy for dvt prophylaxis. exclusion criteria: 1. inability or contraindication to applying ipc to both legs such as: * evidence of bone fracture in lower extremities * burns in the lower extremities, lacerations, ulcers, active skin infection or dermatitis, * ischemic limb in the legs at the site of ipc placement * acute ischemia in the lower extremities * severe peripheral vascular disease * amputated foot or leg on one or two sides * compartment syndrome * severe lower extremity edema * acute deep vein thrombosis 2. subjects who received tpa therapy for their stroke 3. pregnancy or within 6 weeks of postpartum period 4. limitation of life support, life expectancy \< 7 days, or in hospice care 5. a head-unit is unavailable for the first 24 hours or more 6. at the discretion of the attending physician and / or clinical team, the subject's participation in the study is believed not to be in the best interest of the subject.
trial of active immunotherapy with globo h-klh (opt-822/821) in women who have non-progressive ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to evaluate the effect of opt-822/opt-821 on improving progression-free survival (pfs) in subjects who have non-progressive epithelial ovarian, fallopian tube, or primary peritoneal cancer after cytoreductive surgery and platinum-based chemotherapy as initial treatment for primary disease or as salvage treatment for first relapse.


Eligibility criteria:
inclusion criteria: * female subjects ≥ 21 years of age with histologically confirmed ≥ stage ii epithelial ovarian, fallopian tube, and primary peritoneal cancer at diagnosis * who have not progressed after initial treatment with cytoreductive surgery and at least 4 cycles of platinum-based chemotherapy. or * female subjects ≥ 21 years of age with first relapsed epithelial ovarian, fallopian tube, and primary peritoneal cancer (regardless of stage at diagnosis) * who have not progressed after received at least 4 additional cycles of platinum-based chemotherapy with or without having undergone secondary cytoreductive surgery . exclusion criteria: * subjects with evidence of disease progression according to the gcig ca125 criteria or recist 1.1 criteria. * subjects who are currently receiving any other concomitant anticancer therapy. * subjects with evidence of extra-abdominal metastasis.
pharmaceutical care in ambulatory hemodialysis patients

Conditions: Medication Adherence; Chronic Renal Diseases; Renal Failure Chronic Requiring Hemodialysis

Summary: the purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared to usual care, in improving medication adherence behaviour of ambulatory hemodialysis patients.


Eligibility criteria:
inclusion criteria: * aged 18 years or more * chronic renal patients undergoing regular hemodialysis * receiving their scheduled medications (at least one drug) exclusion criteria: * unable to answer the questionnaire or to sign the informed consent form * inability to obtain prescription drugs
therapeutic plasma exchange followed by convalescent plasma transfusion in severe and critically ill covid-19 patients

Conditions: COVID-19 Pneumonia; COVID-19 Respiratory Infection; Acute Respiratory Failure; Acute Respiratory Distress Syndrome

Summary: therapeutic plasma exchange (tpe) has been proposed as a rescue therapy in critically ill covid-19 patients. the aim of this study is to determine whether combining tpe with convalescent plasma (cvp) transfusion early during the intensive care unit (icu) stay, improves survival among this heterogeneous population.

this single centre prospective, non-randomised controlled trial will be conducted in an 8 bed covid-19 icu and will include patients with severe covid-19 pneumonia requiring icu monitoring and therapy. 19 patients will be treated performing tpe followed by cvp transfusion while for 19 patients will receive standard treatment according to hospital protocols. tpe will be initiated during the first 24 hours after icu admission, followed immediately by transfusion of cvp. the primary endpoint is survival at 30 days. secondary endpoints include assessing the evolution of biomarkers, such as the partial pressure of arterial oxygen (pao2) to fractional inspired oxygen (fio2) ratio (p/f ratio), c reactive protein (crp), lactate dehydrogenase (ldh) and ferritin at the 7-day follow-up.

Eligibility criteria:
inclusion criteria: * positive reverse transcriptase pcr test for covid 19 * covid-19 pneumonia * all patients included were adults (\>18 years) * acute respiratory failure exclusion criteria: * pregnant women * patients with suspected or confirmed pulmonary embolism * patients with terminal disease

Keywords: therapeutic plasma exchange convalescent plasma
mental imagery tasks to reduce internet gaming disorder (igd) cravings

Conditions: Internet Gaming Disorder

Summary: to test whether visual and auditory imagery tasks can effectively reduce the craving for igd.

this project is to use imagery tasks to reduce the craving of internet gamers. to test whether visual and auditory imagery tasks can effectively reduce the craving for igd. this project will be conducted in beijing, china, based on a large sample of internet gamers.

Eligibility criteria:
inclusion criteria: * the scores of the 9 items of the diagnostic and statistical manual of mental disorders, fifth edition(dsm-5) recommended diagnosis for internet gaming disorder ≥ 5. * engagement in popular internet games (e.g. arena of valor, league of legends and player unknown's battle grounds) for over 20 hours per week for a minimum of 12 months. * the scores of the young-internet addiction test(y-iat) ≥ 50 exclusion criteria: * current or history of use of illegal substances and gambling; * current or history of psychiatric or neurological illness; * current use of psychotropic medications.
double-blind efficacy and safety of cd5789 (trifarotene) 50µg/g cream versus vehicle cream in acne vulgaris

Conditions: Acne Vulgaris

Summary: assessment of the efficacy and safety of cd5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.


Eligibility criteria:
inclusion criteria: * the subject is a male or female, 9 years of age or older, at screening visit. * the subject has moderate acne at screening and baseline. * the subject is a female of non childbearing potential * the subject is a female of childbearing potential with a negative pregnancy test and who is strictly abstinent or who agrees to use an effective and approved contraceptive method for the duration of the study and at least 1 month after the last study drug application. exclusion criteria: * the subject has severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.). * the subject has any uncontrolled or serious disease or any medical or surgical condition that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the investigator's judgment) if the subject takes part to the trial. * the subject has been exposed to excessive ultraviolet (uv) radiation within one month prior to the baseline visit or the subject is planning intense uv exposure during the study (i.e., occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.) * the subject is unwilling to refrain from use of prohibited medication during the clinical trial

Keywords: efficacy safety acne vulgaris
development and validation of a deep learning-based survival prediction model for pediatric glioma patients: a retrospective study using the seer database and chinese data

Conditions: Glioma

Summary: accurately predicting the survival of pediatric glioma patients is crucial for informed clinical decision-making and selecting appropriate treatment strategies. however, there is a lack of prognostic models specifically tailored for pediatric glioma patients. this study aimed to address this gap by developing a time-dependent deep learning model to aid physicians in making more accurate prognostic assessments and treatment decisions.

this retrospective study focuses on survival prediction in pediatric glioma patients using a population-based approach. the model was trained using the surveillance, epidemiology, and end results (seer) registry database. to identify specific tumor types, the international classification of diseases for oncology, 3rd edition codes (icd-o-3) were used, including codes 9450, 9394, 9421, 9384, 9383, 9424, 9400, 9420, 9410, 9411, 9380, 9382, 9391, 9393, 9390, 9401, 9381, 9451, 9440, 9441, 9442, 9430, and 9380, covering astrocytic tumors, oligodendroglia tumors, oligoastrocytic tumors, ependymal tumors, and other gliomas. inclusion criteria comprised all primary brain tumors (c71.0-c71.9, c72.3, c72.8, c75.3) diagnosed between 2000 and 2018, among patients under 21 years old, and meeting the third edition of the icd-o-3 classification. only patients with available survival time were included, and those with unknown or missing clinical features were excluded. this cohort consisted of 258 pediatric glioma patients diagnosed at tangdu hospital in xi\&#39;an, china, between january 2010 and december 2018. these patients had complete clinical data and comprehensive follow-up records.

Eligibility criteria:
inclusion criteria: * to identify specific tumor types, the international classification of diseases for oncology, 3rd edition codes (icd-o-3) were used, including codes 9450, 9394, 9421, 9384, 9383, 9424, 9400, 9420, 9410, 9411, 9380, 9382, 9391, 9393, 9390, 9401, 9381, 9451, 9440, 9441, 9442, 9430, and 9380, covering astrocytic tumors, oligodendroglia tumors, oligoastrocytic tumors, ependymal tumors, and other gliomas. inclusion criteria comprised all primary brain tumors (c71.0-c71.9, c72.3, c72.8, c75.3) diagnosed, among patients under 21 years old, and meeting the third edition of the icd-o-3 classification. exclusion criteria: * only patients with available survival time were included, and those with unknown or missing clinical features were excluded.
edwards cardioband european post-market study, miband

Conditions: Mitral Regurgitation; Mitral Insufficiency; Mitral Repair; Mitral Valve; Annuloplasty; Edwards Cardioband

Summary: to demonstrate reduction of mr with durable performance and im-provements in functional status

miband is a prospective, single arm, european post-market study to assess the safety and efficacy of the edwards cardioband system. patients will be followed up at 30d, 6months, 1, 2 and 3 years.

Eligibility criteria:
main inclusion criteria: * age ≥ 18 years; * mr (≥ 2+ by echocardiography); * patient is eligible to receive the edwards cardioband mitral system main exclusion criteria: * active bacterial endocarditis * severe organic lesions with retracted chordae or congenital mal-formations with lack of valvular tissue * heavily calcified annulus or leaflets * patients in whom transesophageal echocardiography is contraindicated * patients who cannot tolerate an anticoagulation/antiplatelet regimen * patients with known severe reaction to contrast agents that cannot be adequately pre-medicated. * pre-existing prosthetic heart valve or annuloplasty in the mitral position * life expectancy of less than twelve months * patient is pregnant or lactating
tamsulosin assisted ureteral access sheath insertion

Conditions: Renal Stone; Retrograde Intrarenal Surgery; Urolithiasis

Summary: aim is to study if 1 week of pre operative tamsulosin would enable easier insertion of ureteral access sheath in primary retrograde intrarenal surgery for renal stone disease


Eligibility criteria:
inclusion criteria: * renal stone undergoing retrograde intrarenal surgery exclusion criteria: * not on tamsulosin or other alpha blockers regularly * ureteral stricture * concurrent ureteric stone
epigenetic mechanisms and severe obesity (biological tissue collection)

Conditions: Obesity; Diabetes; Metabolic Diseases; Non-alcoholic Fatty Liver Disease

Summary: the purpose of this study was to evaluate the role of vitamin status and epigenetic mechanisms on severe obesity related-complications.


Eligibility criteria:
inclusion criteria: * indication for bariatric surgery with bmi \> 35 kg/m2 exclusion criteria: * unable to receive clear information * refusal to sign the consent form
binge eating syndrome treatment for older women (bestow)

Conditions: Binge Eating

Summary: twenty women, ages 60 or older, will be consented and enrolled in a single-arm, pilot implementation trial of the age-tailored cognitive-behavioral based be intervention. participants will complete assessments at baseline, post-intervention, and at two follow-up timepoints; weekly be frequency will be collected to monitor progress during the intervention period.

the intervention being studied will be an age-tailored, cognitive-behavioral therapy (cbt) based behavioral intervention for binge eating (be), delivered by the pi, a licensed clinical psychologist, in small group format (4-6 participants per group) over 12-16 weeks. the intervention will utilize behavioral-based strategies to reduce be and improve health behaviors, with content including strategies to improve body image, regulation of eating behaviors, and integration of physical activity with an emphasis on body function, health, and longevity. the final session number, frequency, content, and timeline will be determined during intervention-tailoring process not a part of this clinical trial.

Eligibility criteria:
inclusion criteria: * women * age 60 years and over * binge eating (be) ≥1/week during the past ≥3 months * community-dwelling * able to provide informed consent * consistent medication regimen for 3 months exclusion criteria: * significant cognitive impairment * nursing home, long-term care facility * psychosis or imminent suicide risk * current be treatment

Keywords: binge eating spectrum cognitive-behavioral therapy body image
development of a test battery for measurement of knee function in patients with patellar instability

Conditions: Patella; Joint Instability; Patellofemoral Joint Dislocation

Summary: about six months after patella stabilizing surgery postoperative restrictions are commonly lifted and patients may consider whether a return to activity/sports is feasible. currently, there are no evidence-based criteria to determine a patients readiness for sports and/or activity (rts) following stabilizing surgery. the purpose of this project was therefore to investigate the feasibility of a test battery to evaluate knee function in postoperative follow-up evaluation - and in rts decisions - for patients with patellar instability. banff patellofemoral instability instrument 2.0 and norwich patellar instability score is being translated and validatend in a norwegian population. furter is patients experience of living with patellar instability explored.


Eligibility criteria:
inclusion criteria: * patients who have undergone surgical treatment for recurrent patellar dislocation in helse vest. the investigators will include patients with reconstruction of the medial patella femoral ligament, trochleaplasty, tibial tubercle osteotomy, insall or concomitant procedures. exclusion criteria: * unable to give written informed consent. * medial patellar dislocation. * unable to understand written or spoken norwegian. * patients with other knee injuries.
a trial to assess the pain-control efficacy of intra-articular toradol compared to oral nsaids

Conditions: Arthritic Knee Pain

Summary: the study objective is to determine whether a single intra-articular dose of an anti-inflammatory (toradol) will reduce the need for other analgesic medications and, if so, how long the benefits will last.


Eligibility criteria:
inclusion criteria: * patients with radiographic evidence of osteoarthritis (oa) who present to the ed with a chief complaint of knee pain that the treating provider attributes to their arthritis. exclusion criteria: * acute knee trauma * intra-articular steroid injection within 6 months * history of gout or rheumatoid arthritis * x ray evidence of pathologic fracture, malignancy, or other non-oa cause of symptoms * signs or symptoms or high risk of acute infection: recent fevers and chills; erythema, warmth, or pain out of proportion to exam; history of hemodialysis; history of iv drug use * lidocaine allergy * any contraindication to nsaid therapy, including: allergy; pregnancy; history of renal insufficiency; history of gastritis, gerd or gi bleeding; primary care physician's restriction of its use * contraindication to the procedure, including: hemophilia; history of total knee replacement of the affected joint * an inability to give informed consent; active psychosis; diminished capacity requiring another person to provide consent for medical treatment * an inability to be contacted for follow-up
treating patients with a history of non-life threatening allergic reaction to penicillin with penicillin

Conditions: Penicillin Allergy

Summary: the purpose of this study is to examine whether oral challenge with penicillin for patients with a known history of non-life threatening allergic reaction to penicillin is well-tolerated irrespective of skin-testing results

objective: to examine whether oral challenge with penicillin for patients with a known history of non-life threatening allergic reaction to penicillin is well-tolerated irrespective of skin-testing results long after the event occurred. methods: in this prospective, open-label, controlled, multi-clinical trial, 8702 individuals from primary care clinics were screened for penicillin allergy. 169 patients with a history of non-life threatening allergic reaction to penicillin, dating back at least 3 years, were recruited for study. regardless of the response to penicillin skin testing, patients received the recommended daily dosage of penicillin and amoxicillin on two separate occasions. 2-6 years later a follow-up was conducted to assess the outcomes of further penicillin administration. results: 92.9% of the patients had an allergic reaction 6 years or longer before enrollment in the study. of 272 challenges, 137 were skin-test positive with mild rash in 9 patients (6.6%), and 135 were skin-test negative with similar allergic reaction in 5 (3.7%) (p =.29). at follow-up, 3 of 55 patients (5.5%) who were given a full treatment course of penicillin developed mild skin eruption. conclusions: a positive penicillin skin testing of patients with a history of non-life threatening allergic reaction to penicillin occurring 3 years or longer from the event was not associated with a greater prevalence of adverse reactions to oral challenge with penicillin than a negative one. it is of importance to determine whether oral challenge can serve as a diagnostic procedure for this particular group of patients, thereby saving the need for prior penicillin skin testing.

Eligibility criteria:
inclusion criteria:patients with a history of non-life threatening allergic reaction to penicillin, dating back at least 3 years - exclusion criteria:patients who had a life-threatening anaphylactic reaction to penicillin consisting of unconsciousness or anaphylaxis requiring life-resuscitation and those who had non-ige mediated hypersensitivity reactions -

Keywords: non life threatening allergic reaction oral challenge penicillin skin testing