Kornimate/medical-research-clean huggingface dataset:
a trial to determine weight gain benefits of caloric supplementation for nas infants

Conditions: Neonatal Abstinence Syndrome

Summary: a randomized clinical study in nas infants managed via the eat, sleep, console (esc) approach comparing early weight loss on a standard-caloric density versus high-caloric density feeding regimen.

the aims of the study is to systematically evaluate the benefit of high-caloric diet regimens given to nas infants in the first three weeks of life. breastfeeding is the preferred feeding method for nas infants as it has shown to reduce nas severity and infant weight loss, though women who are not adherent to drug treatment programs or have the potential to use illicit drugs are not able to breastfeed due to the risks posed to the infant. several studies have demonstrated the potential for caloric enhancement of formula and breast milk to support weight gain in nas infants. through a randomized control trial analyzing infant weight gain on standard-calorie vs. high-calorie diet regimens, we aim to quantify weight patterns in nas infants and show that increasing caloric intake can improve weight gain.

Eligibility criteria:
infant inclusion criteria: * infants with nas born to mothers age 18-45 with methadone exposure before or during pregnancy who do not intend to place their infants for adoption * infants \> 2200 g infants at least 36 weeks gestational age * delivered at: yale new haven hospital * mothers/infants able to return to outpatient pediatric provider for 2 month and 4 month weights visits infant exclusion criteria: * infants with major congenital malformations * infants enrolled to nicu \>24 hours for medical conditions other than nas treatment before 3 days of life mother's inclusion criteria - * pregnant women (age 18-45) who have started methadone treatment at obstetrics or other ynhh appointments * confirm methadone treatment is received from a licensed treatment program * confirm that mothers are planning to deliver their infant(s) at yale new haven hospital * confirm that mothers do not intend to place the infant(s) for adoption * confirm mother's willingness to participate in the study (including attending the 2-month and 4-month follow up weigh-ins with pediatrician) * consent forms will be signed and faxed to study staff

Keywords: high-caloric diet regimens
sleep laboratory study of mk0928 in adult patients with primary insomnia (0928-041)(terminated)

Conditions: Primary Insomnia

Summary: a study to evaluate the efficacy, safety and tolerability of mk-0928 in primary insomnia.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of primary insomnia exclusion criteria: * patients with an active psychiatric disorder other than primary insomnia
safety, tolerance and activity of he3286 in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this is a phase ii, double-blind, randomized, placebo-controlled study of the safety, tolerance and activity of he3286 in patients with type 2 diabetes mellitus. patients receiving stable metformin or who are drug-naive will receive study treatment (he3286 or placebo) for a treatment period of 12-weeks.

hollis-eden pharmaceuticals, inc. is developing a new class of therapeutics for the treatment of type 2 diabetes. the investigational drug, he3286, holds the potential to be the first in a new class of insulin sensitizers with a potentially novel mechanism of action that may improve the current therapeutic options available to a t2dm patient. this is a phase ii, double-blind, randomized, placebo-controlled study of the safety, tolerance and activity of he3286 in patients with type 2 diabetes mellitus. patients receiving stable metformin or who are drug-naive will receive study treatment (he3286 or placebo) for a treatment period of 12-weeks. changes in hemoglobin a1c (hba1c) will be assessed over a treatment period of 12-weeks.

Eligibility criteria:
main inclusion criteria: * patient with a diagnosis of type 2 diabetes mellitus (t2dm) * patient must be a) on a stable dose of metformin as monotherapy for at least 10 weeks prior to screening; or b) drug-naive, defined as never having received drug treatment for t2dm or not having received antidiabetic drug therapy during the 3 months prior to screening. * patient with a fasting blood glucose level of ≤ 225 mg/dl at screening (≤ 255 mg/dl for drug-naive patients); * patient with hba1c levels \>7.5% (7.0 - 10.5% for drug-naive patients) at screening; * patient with bmi 28-37 kg/m2 for females 28-39 kg/m2 for males main exclusion criteria: * patient who has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities within 6 months prior to screening; * patient with unstable diabetic complications requiring treatment or ongoing active intervention; * patient with a history of long term insulin therapy within the past year; * patient who has had therapy with rosiglitazone, pioglitazone, exendin-4 or sitagliptin, alone or in combination within 6 months prior to screening; * patient who has any clinically significant abnormalities in laboratory results at screening;

Keywords: type 2 diabetes mellitus metformin hba1c
hypnosis for children undergoing anorectal manometry

Conditions: Constipation

Summary: partially blinded randomized controlled trial investigating the effect of a brief session of hypnosis prior to anorectal manometry in children


Eligibility criteria:
inclusion criteria: * children aged 4-18 who are scheduled to undergo anorectal manometry testinf. * asa classification i to ii. * both parents and children have sufficient english language proficiency. * both parents and children are willing to fill out the questionnaires involved in this study. exclusion criteria: * asa classification iii, iv (children with a chronic or severe disease). * children with a metabolic, endocrine or neuromuscular disorder or mental illness. * children with anorectal malformations or previous anorectal surgery. * children with developmental delay * children with diagnosed emotional or behavioral disorders

Keywords: hypnosis anorectal manometry child
the core buprenorphine project - an hiv primary care program demonstration

Conditions: HIV Infections; AIDS; Opiate Dependence; Post-Traumatic Stress Disorders

Summary: the goal of this study is to develop and evaluate an innovative model of care to better serve patients who are both hiv-infected and opioid-dependent.

hypothesis: hiv, opioid dependent patients provided agonist therapy at the site of their primary care will have better retention, utilization of services, health, social and quality of care measures and psychiatric treatment outcomes. the buprenorphine project is an examination of two methods of service delivery. the purpose of this study is to assess the feasibility, cost and effectiveness of an intervention designed to integrate buprenorphine treatment for opioid dependence into hiv primary care at the core center. for this project we will provide buprenorphine to 60 opioid dependent patients at any one time and will compare this on-site treatment group to 60 opioid dependent hiv+ patients who select off-site methadone or no agonist treatment at the time of enrollment.

Eligibility criteria:
inclusion criteria: * 18 years or older * patient of the core center * hiv-infected (confirmed by hiv assay results) * opioid-dependent (by diagnostic and statistical manual of mental disorders, fourth edition, text revision \[dsm-iv-tr\] criteria) * fluent in english or spanish * planning to stay in chicago area for the next 12 months exclusion criteria: * liver function tests (lfts) (transaminase only) at 5 times or higher than normal * dsm-iv-tr criteria for benzodiazepine abuse or dependence within the past 6 months * dsm-iv-tr criteria for alcohol dependence within the past 6 months or actively suicidal * psychiatric impairment that impedes ability to consent * methadone dose exceeds level allowing for safe transition to buprenorphine * pregnant women or women actively trying to become pregnant * clinical judgement that patient is inappropriate for medical or psychiatric reasons

Keywords: hiv aids buprenorphine methadone primary care dual diagnosis ptsd
wound antiseptic study with hypochlorous acid & iodopovidone

Conditions: Surgical Site Infection

Summary: the purpose of this study is to determine whether hypochlorous acid is an effective antiseptic agent to prevent surgical site infection.

a topical antimicrobial that decrease the bacterial bioburden of surgical wounds without impairing the wound's ability to heal is a need. a stabilized form of hypochlorous acid has been demonstrated in vitro and in animal studies to possess properties that could fulfill these criteria but it is imperative to assess its efficacy and safety in humans. to assess hypochlorous acid efficacy and safety, it was designed a clinical controlled randomized trial to compare hypochlorous acid to iodopovidone, the gold standard, in preoperative scrub of surgical area.

Eligibility criteria:
inclusion criteria: * all patients over 18 years old, who are going to be operated * classification of surgical wounds according to the national research council as class i or ii * risk index classification of the american society of anaesthesiology (asa) as asa 1 or 2 exclusion criteria: * patients requiring mesh or prosthesis or orthesis

Keywords: hypochlorous acid colony forming units surgical site infection nosocomial infection bacterial bioburden wound healing
post-market study to assess outcomes of patients treated with afx system compared to other evar devices

Conditions: Abdominal Aortic Aneurysm

Summary: the objective of this post-market trial is to evaluate endologix afx endovascular aaa system with anatomical fixation against other approved endovascular systems with proximal fixation. multiple u.s clinical centers will be involved in the trial to include a broad range of experience. imaging data will be evaluated by an independent core lab.

this trial is a prospective, randomized, multi-center trial, intended to evaluate the outcomes of contemporary evar (endovascular aneurysm repair) in a real world population. the trial is designed to compare the anatomically stabilized afx endograft system to a reference group of proximally fixated evar devices. patients will be randomized between the two groups. randomization will be 1:1. each investigator will select one comparator device of their choice before enrolling the first patient. the study will sequentially evaluate non-inferiority and superiority hypotheses. up to 80 sites with experience in evar and up to 800 subjects will participate in this study.

Eligibility criteria:
inclusion criteria: 1. male or female at least 18 years old 2. subjects with minimum of 2 year life expectancy 3. subjects have signed the informed consent document for data release 4. subjects with infrarenal aaa who are assessed by the investigator to be eligible for endovascular abdominal aortic aneurysm repair with the trial devices. exclusion criteria: 1. currently participating in another study where primary endpoint has not been reached yet 2. known allergy to any of the device components 3. pregnant (females of childbearing potential only) 4. subjects with pre-existing evar, e.e. in need of repair/intervention of a previously failed evar
comparative effects of motor relearning programme versus mirror therapy on balance and gait in chronic stroke patients

Conditions: Stroke

Summary: to determine the effect of motor relearning program versus mirror therapy for balance and gait in chronic ischemic stroke patients


Eligibility criteria:
inclusion criteria: * • chronic ischemic stroke of six or more than six months. * patients with age - 45- 65 years. * patients with good cognitive status i.e. 20 or more on mmse.(mini mental status examination). * patients of both genders * patients with ambulation before stroke. exclusion criteria: * • patients who have musculoskeletal disorder impending lower limb function. * patient with any other neurological disease. * patients have severe lower limb deformities, and vestibular disorders. * patients who have any joint disorder of lower limb. * patients who have any cardiac problem. * patients with history of recurrent stroke.
the effect of music accompanied aerobic exercise

Conditions: Fibromyalgia; Fibromyalgia (FM); Syndrome Pain; Exercise

Summary: objective: the aim of this study, which was planned as a single-blind randomized controlled design, was to investigate whether aerobic exercise accompanied by music has positive effects on pain, quality of life and well-being in patients with fibromyalgia syndrome. materials and methods: the study sample consisted of 80 patients diagnosed with fibromyalgia syndrome the patients were randomly assigned to either the experimental (n=40) or control group (n=40) using a computer-based randomization method. data collection tools included the personal information form , fibromyalgia impact questionnaire scale , state anxiety scale (stai-i/stai ii) , psychological well-being scale

objective: the aim of this study, which was planned as a single-blind randomized controlled design, was to investigate whether aerobic exercise accompanied by music has positive effects on pain, quality of life and well-being in patients with fibromyalgia syndrome. materials and methods: the study sample consisted of 80 patients diagnosed with fibromyalgia syndrome the patients were randomly assigned to either the experimental (n=40) or control group (n=40) using a computer-based randomization method. data collection tools included the personal information form , fibromyalgia impact questionnaire scale , state anxiety scale (stai-i/stai ii) , psychological well-being scale

Eligibility criteria:
inclusion criteria: * being diagnosed with fibromyalgia according to the 2016 american college of rheumatology criteria in the physical therapy and rehabilitation unit of the university of health sciences kanuni sultan süleyman training and research hospital, * being between the ages of 18 and 65, * volunteering to participate in the study. * having no problem with perception * being diagnosed with fibromyalgia at least 6 (six) months ago. * not using any alternative treatment method (acupuncture, mud, etc.). exclusion criteria: * cardiovascular, respiratory, metabolic and rheumatic diseases that may limit exercise; * diseases associated with autonomic dysfunction such as arterial hypertension, diabetes and coronary insufficiency; * having exercised in the last 3 months, * having a disease that causes problems in understanding the questionnaires * pregnancy or breastfeeding. * history of surgery in the last four months.

Keywords: fibromyalgia syndrome exercise
anal crohn fistula surgery

Conditions: Crohn Disease; Fistula; Anoperineal Fistula; Anal Fistula

Summary: the purpose of this study is to demonstrate, in patients treated with adalimumab, the efficacy of proctological surgery in anoperineal fistula healing after the removal of seton drain.


Eligibility criteria:
inclusion criteria: * male or female 18 years or older, * women of childbearing age who use an effective contraception method or women incapable of becoming pregnant \[(i.e. postmenopausal women for 1 year or surgically sterile (hysterectomy and/or bilateral oophorectomy)\], * patient with fistulizing anoperineal crohn's disease. anoperineal fistulas can be associated with ileal, colic or rectal lesions, * patient with at least 1 anoperineal fistula drained with a seton for more than 1 month, * patient treated with adalimumab for more than 1 month, * patient who agrees to undergo surgery for its drained fistula(s), * patient with immunosuppressive therapy (azathioprine, 6-mercaptopurine ou methotrexate) stable for at least 3 months or patients without immunosuppressive therapy, * patient who gave signed written informed consent after having received verbal explanation and written information related to the trial. exclusion criteria: * pregnant or breastfeeding women, * patient having a perineal abscess, * patient with a high anovaginal fistula that cannot be treated, according to the investigator ,with fistulotomy, gluing, biodegradable plug or advancement flap, * patient treated with a daily dose of corticosteroids of more than 20 mg (a dose of more than 20 mg daily will be authorized during the study), * contraindication to proctological surgery on the drained fistula(s), * patient presenting with somatic or psychic signs or symptoms that are not compatible with his/her participation in the trial according to the investigator, * patient who participate in another clinical trial.

Keywords: crohn disease anoperineal fistula anal fistula proctology drainage colorectal surgery fistulotomy plug advancement flap glue anti tumor necrosis factor-alpha adalimumab
application of an early in-hospital temperature management protocol for heat stroke patients

Conditions: Heat Stroke

Summary: heat stroke is a life-threatening clinical syndrome characterized by an imbalance between heat production and heat dissipation in the body, resulting from exposure to hot and humid environments and/or strenuous exercise. it is defined by an elevated core temperature exceeding 40°c and central nervous system abnormalities, accompanied by multi-organ dysfunction. the severity of cellular and tissue damage in heat stroke patients depends on the peak temperature reached and the duration of hyperthermia. rapid reduction of core temperature can halt cellular damage, quickly reverse organ dysfunction, and improve patient outcomes. therefore, early identification and rapid cooling are crucial to prevent irreversible damage and death in heat stroke patients. however, there is a lack of systematic and specific protocols to guide emergency medical staff in the standardized and effective management of body temperature in heat stroke patients. to address this, our research team previously developed an early in-hospital temperature management protocol for heat stroke patients based on the best available evidence, expert consultations, and expert panel meetings. this study aims to validate the feasibility and effectiveness of the protocol through clinical research, providing a basis for clinical practice.


Eligibility criteria:
inclusion criteria: * patients admitted to the emergency department and diagnosed with heat stroke according to the china expert consensus on heat stroke exclusion criteria: * transferred from another hospital and body temperature \< 39.5℃; discharged within 4 hours, and subsequent body temperature or outcomes were unavailable; required immediate cardiopulmonary resuscitation; had other serious diseases, such as massive cerebral haemorrhage or severe trauma.
comparison of three knee replacements

Conditions: Osteoarthritis, Knee; Arthroplasty; Total Knee Replacement

Summary: the present randomized controlled trial is designed to compare one novel total knee replacement (tkr) design and two conventional tkr designs in terms of functional outcome. 80 patients will be randomized in each of the three arms (240 altogether).

the study will compare the short-term functional outcome (at 2 years) of tkr performed with a novel tkr design (persona , zimmer, warsaw, in, usa) against tkrs performed with two conventional designs (pfc, depuy, warsaw, in, usa and nexgen, zimmer, warsaw, in, usa).

Eligibility criteria:
inclusion criteria: * patients undergoing total knee replacement surgery for primary osteoarthritis * no previous open major surgery in the joint ( e.g. osteotomy) * unilateral operative treatment, with no plans for surgical treatment of the contralateral knee in the near future * patients living in the local hospital district (pirkanmaa hospital district) * kellgren-lawrence grade 3-4 knee osteoarthritis in plain radiographs exclusion criteria: * unwilling to provide informed consent * \> 15 degrees varus or valgus, or \>15 degree fixed flexion deformity * predominantly patellofemoral osteoarthritis * physical, emotional or neurological conditions that would compromise the patient´s compliance with postoperative rehabilitation and follow-up (e.g. drug or alcohol abuse, serious mental illness, general neurological conditions such as parkinson, ms, etc.)
prevention after stroke - a nurse-led physician-supervised model

Conditions: Stroke

Summary: the study evaluates the effect of early follow up in a preventive clinic with stepwise treatment of high blood pressure and lowering blood cholesterol. half the participants were randomized to the preventive clinic group and the other half to control group with the usual treatment: one visit to the outpatient clinic three months after discharge with a diagnosis of stroke or transient ischemic attack (tia)

hypertension is the most important modifiable risk factor for recurrent stroke. several studies have shown that less than 40% of stroke survivors are treated to target one year after stroke the investigator performed a feasibility study to test a model of treating this important risk factor in a hospital setting the investigator used a stepwise escalation of treatment of both blood pressure and blood cholesterol to individual targets according to patients' diagnosis of stroke, comorbidity and age

Eligibility criteria:
inclusion criteria: patients diagnosed with a stroke during stay in the stroke unit of herlev hospital exclusion criteria: severe stroke giving a modified rankin scale score \>4, severe cognitive deficits or dementia, discharge to a nursing home
safety study in subjects ≥ 12 years of age with hereditary angioedema switching to garadacimab

Conditions: Hereditary Angioedema

Summary: this study is designed to evaluate the safety after switching to garadacimab from another prophylactic hereditary angioedema (hae) treatment (marketed kallikrein \[kk\] inhibitor or plasma-derived c1-esterase inhibitor \[pdc1inh\]prophylactic) when administered once monthly for approximately 3 months in participants aged greater than or equal to (\>=) 12 years with hae.


Eligibility criteria:
inclusion criteria: * aged \>= 12 years at the time of providing written informed consent / assent. * have a history of response to on-demand hae treatment for the treatment of acute hae attacks. * documented laboratory diagnosis in medical records of c1-esterase inhibitor hereditary angioedema (hae-c1inh) type 1 or type 2: * documented clinical history consistent with hae (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria), * c1-esterase inhibitor (c1inh) antigen concentration or functional activity less than (\<) 50% of normal as documented in the participant's medical record, or * c4-antigen concentration below the lower limit of the reference range as documented in the participant's medical record. for hae-nc1inh: documented clinical history consistent with hae (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria); an hae-associated fxii gene mutation (eg, fxii point mutation thr328lys or thr328arg, or deletion of 72 base pairs \[c.971_1018 + 24del72\], or duplication of 18 base pairs \[c.892-909dup\]), as documented in the participant's medical record, or an hae-associated plasminogen gene mutation (plg) gene mutation (eg, plg point mutation lys330glu), as documented in the participant's medical record; c1inh antigen concentration or functional activity 70 to 120% of the normal level, as documented in the participant's medical record. • use of lanadelumab, berotralstat, or pdc1inh for the prophylactic treatment of hae and be on a stable (consistent) dose / regimen of such medication for at least 3 months prior to screening. exclusion criteria: * concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria. * use of androgens, antifibrinolytics, or investigational products (other than garadacimab) for routine prophylaxis against hae attacks. * known or suspected hypersensitivity to monoclonal antibody therapy or hypersensitivity to the active substance (garadacimab) or to any of the excipients.

Keywords: autosomal dominant disease hereditary angioedema attack monoclonal antibody