Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of empiric levothyroxine (lt4) dose increase versus individualized lt4 dose increase in hypothyroid women during pregnancy

Conditions: Pregnancy Related; Thyroid

Summary: in women who require thyroid hormone replacement medication, the investigators will compare 2 ways to adjust thyroid medication during pregnancy to determine superiority in maintaining optimal blood levels of thyroid hormone. thyroid hormone requirements increase significantly in pregnancy and it is important that blood levels of thyroid hormone remain normal so the fetus, which cannot make its own thyroid hormone has enough for early prenatal development. this trial compares 2 methods for adjusting thyroid medicine during pregnancy in women with known thyroid disease. pregnant women (age 18 to 45) who take thyroid medication will be randomized to either 1) a 2-dose per week increase in thyroid medicine once pregnancy is confirmed, followed by dose adjustments every 2-4 weeks, or 2) adjustments in thyroid medication every 2-4 weeks in micrograms per day based on results of blood tests. the investigators will compare thyroid hormone levels throughout pregnancy between the groups of mothers to determine which method is superior in meeting the increased thyroid hormone requirements during pregnancy.


Eligibility criteria:
inclusion criteria: * female between ages of 18-45 who takes thyroid hormone replacement medicine and pregnant or plan to become pregnant in the near future. exclusion criteria: * males * younger than 18 or older than 45 years old * more than 10 weeks pregnant at enrollment * iodine deficient * pregnant with more than one baby (i.e., twins, triplets, etc.) * not taking thyroid hormone medicine before becoming pregnant * levels of thyroid hormone in blood have been too low or too high in the past 6 months * treated with radioactive iodine in the past year.

Keywords: thyroid stimulating hormone
potato consumption and energy balance

Conditions: Obesity

Summary: a randomized, clinical trial will be performed to assess changes in body weight and fat mass with daily potato consumption versus a calorie-matched snack of almonds.

this is a 30-day randomized, controlled trial with 3 arms: 1) non-potato food (almonds), 2) standard white potato french fry, 3) standard white potato french fry with potential glycemia-modulating spice/seasoning mix added. free-living study participants will be assigned to consume one of the 3 foods (calorie matched) each day for a 30-day period. body composition (via dual energy x-ray absorptiometry; dxa), and blood chemistry will be assayed at baseline and study completion, along with a sub-sample of subjects participating in a meal-based tolerance tests at study completion.

Eligibility criteria:
inclusion criteria: * 18- 50 years old * body mass index (bmi) 20- 35 * no dietary restrictions or allergies * weight stable * access to camera through smartphone, computer or tablet exclusion criteria: * pregnancy or anticipating pregnancy or lactation * nut or food allergy * diagnosed diabetes (type 1 or 2) * history of weight control surgery (bariatric or liposuction) * consumes \>1 serving of potatoes daily before enrollment * weight loss or gain \>5% within past 6 months * medical conditions or medications that would prevent the ability to comply with treatment assignment and/or affect energy balance * dependence on others for food procurement or preparation

Keywords: nutrition intervention potato consumption energy balance
procalcitonin and presepsin-guided decision for antibiotic prophylaxis of eos

Conditions: Early-Onset Neonatal Sepsis

Summary: the goal of this randomized controlled study is to compare the outcome of preterm infants who will receive the standard antibiotic prophylaxis for eos or procalcitonin/presepsin-guided antibiotic prophylaxis of early onset sepsis (eos). the main question it aims to answer is: • does procalcitonin/presepsin-guided antibiotic prophylaxis of (eos) increase survival without major morbidities, including ivh \>3 grade, pvl, rop \>3 grade in either eye, nec \>2 grade, bpd, or los. infants with gestational age between 25+0 and 31+6 weeks of gestation or a birth weight \<1500 g will be eligible for enrollment in the study. participants will be randomized to receive standard antibiotic prophylaxis for eos (standard group) or to receive antibiotic prophylaxis for eos on the basis of pct/p-sep measured within 3 h of life (intervention group).


Eligibility criteria:
inclusion criteria: * infants of 25+0- 31+6 weeks of gestational age will be enrolled in the study. exclusion criteria: * risk factors for eos: * maternal gbs colonization without adequate prophylaxis; * clinical chorioamnionitis diagnosed by maternal intrapartum fever (either a single documented maternal intrapartum temperature of ≥39.0°c or a temperature of 38.0-38.9°c that persists for \>30 minutes) and 1 or more of the following: (1) maternal leukocytosis, (2) purulent cervical drainage, and (3) fetal tachycardia; * pre-labor rupture of membranes (rom) \>1 h before delivery. * surgery within the first week of life, * major congenital malformations, * chromosomal syndromes, * inherited metabolic disorders, * fetal hydrops

Keywords: early-onset sepsis procalcitonin presepsin preterm infant
influence of patient-informed choice in a novel treatment model for lbp

Conditions: Mechanical Low Back Pain

Summary: 1. (primary) to compare the effectiveness of a patient guided choice of care using a patient decision support tool to clinical guided care within a novel care process for non-specific low back pain. (we hypothesize that the patient guided choice model will demonstrate significant improvements when compared to the clinician guided care approach) 2. (secondary) to qualitatively investigate which components of the patient choice educational methods were most effective for informed decision making among patients who participate in the patient guided choice of care approach (we hypothesize that dialogue method of patient guided choice will be identified as most useful)

the purpose of this research study proposal is to evaluate patient choice within this physical therapist-led model for non-specific low back pain. evidence exists that patients are eager to play an active role in decisions concerning their health. recent evidence from research supports the benefit of decision aides for consumers, especially those that were accurate and refined to the specific problems of each patient. in our proposed randomized controlled trial (rct), one group of patients in the study will have the opportunity to drive choices within their healthcare model; but only after receiving useful information on what the consequences of their selections will be. patients will receive decision making information to assist in making an informed choice. the structured information will organize known results from the research literature to assist patients in understanding the likely outcome of their condition and what they need to adequately manage their own care. the control group of patients will receive the physical therapist-directed care model that is presently used and has shown success. patient outcomes will involve patient self report of improvement and whether or not the patient pursued care for the same condition over a 1 year period of time.

Eligibility criteria:
inclusion criteria: * 18 years of age or older with mechanically producible lbp exclusion criteria: * the presence of any red flags (i.e., tumor, metabolic diseases, ra, osteoporosis, prolonged history of steroid use, etc.), or signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°, muscle weakness involving a major muscle group of the lower extremity, diminished lower extremity muscle stretch reflex, or diminished or absent sensation to pinprick in any lower extremity dermatome). other exclusion criteria include prior surgery to the lumbar spine and current pregnancy.

Keywords: low back pain
optimization of a photoretinoscopy method for determining the objective refraction of children with a smartphone/add-on device in india

Conditions: Ametropia

Summary: the objective is to compare the refractive parameters of the photorefraction prototype device without cycloplegia with the refractive parameters of reference device, an autorefractometer with and without cycloplegia.

a single visit will be necessary. after informed consent, and checking of the inclusion and exclusion criteria, investigators will perform measurements with an autorefractometer and with the photorefraction prototype device without cycloplegia followed by an objective refraction with an autorefractometer under cyclopegia.

Eligibility criteria:
inclusion criteria: * voluntary, willing to follow the protocol, able to read and understand the information form and give free and informed consent (for parents/guardian of children subjects) and assent (for subjects aged 6-12 years old * at least 6 years old and up to 12 years old at time of informed consent and assent * average of the equivalent sphere(sph+cyl/2) of both eye included in the interval \[-10.00, +8.00\] * cylindrical refractive error between 0 and 4.00 d on both eyes * corrected binocular visual acuity in distance vision at least 6/9 exclusion criteria: * incapable of expressing consent * all categories of persons particularly protected by law * subject in another study which might have an influence on vision or interfere with study assessment * less than 6 years old, or 13 years old or above at time of informed consent and assent * amblyopia, cataract, strabismus. * aphakic or pseudophakic (intraocular implant) * reported severe eye disease involving loss of visual field as in glaucoma, involving loss of acuity and severe discomfort in low or overly bright environments as in retinitis pigmentosa or reported and treated dry eye. * self-reported neurological deficits, including a history of epileptic pathology or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders, nystagmus) * any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery...), * any myopia control solutions that could affect refractive status of the eye (e.g. atropine eye drops, orthokeratology)
herbal medication (gongjin-dan) for chronic dizziness

Conditions: Dizziness Chronic

Summary: this is a prospective, multicenter, randomized, double-blinded, placebo-controlled, parallel-group, clinical trial to explore the effectiveness of an herbal medication, gongjin-dan (gjd) for chronic dizziness (ménière disease, psychogenic dizziness, or dizziness of unknown cause), identified as liver-deficiency pattern/syndrome, and assessed with dizziness handicap inventory (dhi) ≥ 24 at baseline. participants will be randomized and allocated to either gjd or placebo group with 1:1 ratio and orally administered gjd or placebo pills once a day for 8 weeks. for collecting data for cost-effectiveness analysis, the participants will be followed up to 12 months from randomization.


Eligibility criteria:
inclusion criteria: 1. age between 20 and 79 years, of either sex 2. dizziness originating from ménière disease, psychogenic cause, or unknown cause 3. recurring symptom of dizziness for more than 1 month 4. dizziness handicap inventory (dhi) score ≥ 24 at baseline 5. liver-deficiency pattern/syndrome identified by traditional korean medicine doctors 6. willingness to provide written informed consent exclusion criteria: 1. dizziness attributable to vestibular disorders (e.g., benign paroxysmal positional vertigo, peripheral vestibulopathy, labyrinthitis, vestibular neuronitis, and others) 2. dizziness attributable to central nervous system (cns) disorders (e.g., cerebellar ataxia, stroke, demyelination, vertebrobasilar insufficiency, seizure, increased intracranial pressure, parkinson's disease, migraines, and others) 3. cervicogenic dizziness 4. dizziness attributable to cardiovascular disorders (e.g., arrhythmia, heart valvular disease, anemia, orthostatic hypotension, coronary artery disease, and others) 5. any active or uncontrolled disease that might cause dizziness (e.g., uncontrolled diabetes mellitus, hypertension, respiratory or endocrinological disorders, and others) 6. dizziness attributable to medication side effects 7. severe chronic or terminal diseases (malignant cancer, tuberculosis, and others) 8. intake of other antivertiginous drugs that cannot be discontinued 9. following physiotherapy, manual therapy (e.g., vestibular rehabilitation), and/or cognitive behavioral therapy for the treatment of dizziness 10. aspartate aminotransferase (ast), alanine aminotransferase (alt), blood urea nitrogen (bun), or creatinine \> 3 × upper limit of normal range at baseline 11. women of (suspected) pregnancy or breast-feeding 12. allergic reactions to the study medications 13. suspicion of alcohol and/or drug abuse 14. enrollment in another clinical study presently or within 30 days prior to the initial administration of the study medications 15. difficulty in reliably communicating with the investigators or likelihood of inability to follow instructions 16. other reason for ineligibility of participation
cefiderocol plasma concentrations in patients receiving renal replacement therapy

Conditions: Pharmacokinetics

Summary: continuous renal replacement therapies (crrt) such as continuous venovenous hemofiltration are used to provide renal support for critically ill patients with acute kidney injury (aki), particularly patients who are hemodynamically unstable. it is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. there is a need to understand how crrt affect the pharmacokinetics and disposition of drugs. this study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, cefiderocol, in critically ill patient receiving crrt.

this is a prospective, multi-center, open-label, phase 1b, pharmacokinetic study of cefiderocol in 16 critically ill patients receiving crrt support. informed consent will be collected from all study participants, legal authorized representative, or their next of kin in order to participate. this is not a treatment study; all participants will receive standard of care antibiotics which may include cefiderocol as necessary to treat any current infection.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older; 2. receiving crrt including cvvh, cvvhd, and cvvhdf support. exclusion criteria: 1. females who are pregnant or breast-feeding; 2. history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication); 3. a hemoglobin less than 8 gm/dl at baseline; 4. acute liver injury, defined as aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 5 times the upper limit of normal, or ast or alt \> 3 times the upper limit of normal with an associated total bilirubin \> 2 times upper limit of normal; 5. any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator); 6. any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data.
transformative audio storytelling

Conditions: Caregiver Burden

Summary: pilot testing the feasibility of the transformative audio storytelling approach for informal caregivers, as an innovative method for delivering potentially empowering mental health narratives.


Eligibility criteria:
inclusion criteria: * informal caregiver (family members or significant other person who provides primary care for the patients visiting or being hospitalized in the rehabilitation ward) * age ≥18 years * native speaker of the italian language * having voluntarily agreed to participate in the study and having signed the informed consent in all its points. exclusion criteria: * informal caregiver for children * informal caregiver who does not personally play this role (primary caregiver) * informal caregiver of adults with a tumor pathological condition

Keywords: audio storytelling informal caregivers digital narratives
pre-emptive kidney transplantation quality of life

Conditions: Renal Insuffiency; Kidney Transplantation

Summary: the main objective is to assess the psychological impact of pre-emptive kidney transplantation on patients' quality of life taking into account psychological adjustment (response shift), compared to patients who have experienced a short pre-transplant dialysis period of less than 36 months.

the following outcomes will also be compared between patients with pre-emptive transplantation and patients with dialysis before transplantation : a) changes in quality of life, subjective well-being, perceived anxiety and depressive disorders as well as perceived stress during follow-up taking into account psychological adjustment (response shift) ; b) the coping strategies (process of managing stressful circumstances) and post-traumatic growth (positive psychological change experienced as a result of the struggle with highly challenging life circumstances) ; c) the 2-year post transplantation graft survival and patient outcomes: evolution of the graft filtration rate, the proteinuria level ; d) the kidney transplant failure score (ktfs, patent n°0959043) at one year post transplantation ; e) the post-transplantation time to return to work and patients compliance to treatment.

Eligibility criteria:
inclusion criteria: * adult patients with a pre-emptive transplantation from deceased and living donor and patients who have experienced a pre-transplant dialysis period of less than 36 months (matched inclusion on recipient gender and center). * only first and single kidney transplantation will be considered. exclusion criteria: * re-transplantation or simultaneous transplantation (kidney-pancreas for instance) * patients under guardianship.

Keywords: end stage renal disease renal transplantation dialysis pre-emptive transplantation psychological adjustment quality of life.
diagnostic accuracy of point of care test of first voided urine compared to midstream voided urine in primary care

Conditions: Urinary Tract Infections

Summary: the aim of this study is to determine if sampling technique of urine affects diagnostic modalities in primary care. furthermore it aims to determine if there is difference in the accuracy of the point-of-care test, when the urine sample is stored at room-temperature and analyzed later in the day.

125 patients with one or more symptoms of urinary tract infections, contacting their gp, are asked to make 2 urine samples from the same void. the patient is asked to void firstly in one cup, approximately 10-20 ml., then stop voiding. then the patient is asked to void the rest into a second cup. this way there is collected both a first-void and a midstream-void from the same patient and the same void. all the samples are analyzes using urine-dipstick, microscopy and point of care test urine culture. the urine of the midstream void is sent to a microbiology lab for analyzes as well. furthermore the test are analyzes again after 1 and 4 hours.

Eligibility criteria:
inclusion criteria: * symptoms of urinary tract infection exclusion criteria: * men * pregnancy * children * unable to understand the verbal and written guide
study of regn4461, a leptin receptor agonist antibody, in patients with generalized lipodystrophy

Conditions: Generalized Lipodystrophy

Summary: the primary objectives of the study are to estimate the effects of regn4461 on glycemic parameters in the subset of patients with elevated baseline hemoglobin a1c levels (hba1c ≥7%) and to estimate the effects of regn4461 on fasting triglyceride levels in the subset of patients with elevated baseline fasting triglycerides (tg ≥250 mg/dl). the secondary objectives are to estimate the effects of regn4461 on a composite endpoint of changes in either hba1c or fasting tg for all patients, estimate the effects of 3 dose levels of regn4461 on glycemic parameters and fasting tg, to estimate the effects of regn4461 on insulin sensitivity, to evaluate the safety and tolerability of regn4461 and to evaluate the pharmacokinetics (pk) and immunogenicity of regn4461.


Eligibility criteria:
key inclusion criteria: * diagnosis of congenital or acquired generalized lipodystrophy (gld), as defined in the protocol * presence of one or both of the following metabolic abnormalities at screening: 1. hba1c ≥ 7% or 2. fasting tg ≥250 mg/dl * generally stable diet (based on patient's recall) and medication regimen (that optimizes treatment for their metabolic disease) for at least 3 months prior to the screening visit key exclusion criteria: * treatment with metreleptin within 1 month of the screening visit * treatment with over-the-counter or prescription medications for weight loss within 3 months prior to the screening visit * treatment with oral glucocorticoids \>7.5 mg prednisone equivalents per day within 3 months prior to screening visit or plans to begin treatment with oral glucocorticoids \>7.5 mg prednisone equivalents per day during the study period * history of human immunodeficiency virus (hiv) or hiv seropositivity at screening visit * uncontrolled infection with hepatitis b or hepatitis c infection, or known active tuberculosis at screening * participation in any clinical research study evaluating an investigational product (ip) or therapy within 3 months and less than 5 half-lives of ip prior to the screening visit. * pregnant or breast-feeding women note: other protocol defined inclusion/exclusion criteria apply.
resure sealant post approval study

Conditions: Adverse Events

Summary: this is a prospective multicenter observational post-approval registry study that will collect post-approval data relative to the incidence of pre-specified adverse ocular events for cataract surgery patients treated with the fda-approved resure sealant when used by a broad group of physicians under commercial use conditions.


Eligibility criteria:
inclusion criteria: * subject has a cataract and is expected to undergo clear corneal cataract surgery with intraocular lens placement exclusion criteria: * resure sealant is not applied to the operative eye