Kornimate/medical-research-clean huggingface dataset:
a study of retatrutide (ly3437943) in participants with obesity and cardiovascular disease

Conditions: Obesity; Cardiovascular Diseases

Summary: the main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (cvd). the study will last about 113 weeks.


Eligibility criteria:
inclusion criteria: * have a body mass index (bmi) ≥35.0 kilogram/square meter (kg/m²). * have established cardiovascular (cv) disease with at least 1 of the following: * prior myocardial infarction * prior ischemic or hemorrhagic stroke, or * symptomatic peripheral arterial disease * have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight. exclusion criteria: * have had acute myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure within 90 days prior to screening. * have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening. * have a prior or planned surgical treatment of obesity. * have a change in body weight greater than 5 kg (11 pounds) within 90 days prior to screening. * have type 1 diabetes. * have family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men-2) * have had pancreatitis.
sorafenib maintenance for prophylaxis of leukemia relapse in allo-hsct recipients with flt3 negative acute leukemia

Conditions: Acute Leukemia; Relapse; Hematopoietic Stem Cell Transplantation

Summary: the purpose of this study is to evaluate the efficacy and safety of sorafenib maintenance after allo-hsct in flt3-negative acute leukemia patients.

sorafenib is a multikinase inhibitor that blocks multiple pathways involved in the development and progression of acute leukemia, such as flt3-itd, the ras and raf gene families, kit, and the vegf and pdgf receptors. recently, two back-to-back randomized controlled trials both reveal that sorafenib maintenance after allo-hsct could prevent relapse in patients with flt3-itd aml, resulting in a survival benefit. sorafenib has also been explored in the treatment of acute leukemia without flt3 mutations and shown promising results. currently, relapse remains the major cause of transplant failure, especially for high-risk and refractory acute leukemia patients. once patients relapse after allo-hsct, the prognosis is dismal. therefore, prevention of relapse is of great importance to improve the prognosis. based on the current research status, we plan to conduct a prospective, multicenter, phase 2 randomized controlled trial to explore the efficacy and safety of sorafenib maintenance after allo-hsct in flt3-negative acute leukemia patients.

Eligibility criteria:
inclusion criteria: * patients with flt3-negative acute leukemia undergoing first allo-hsct * age 18 to 65 years old with ecog performance status 0-2 * hematopoietic recovery within 60 days post-transplantation * sign informed consent form, have the ability to comply with study and follow-up procedures exclusion criteria: * acute promyelocytic leukemia (aml subtype m3) * acute leukemia with flt3-itd or flt3-tkd mutations * philadelphia-positive acute lymphoblastic leukemia * chronic myelogenous leukemia with blast crisis * intolerance to sorafenib pre-transplantation * life expectancy less than 30 days post-transplantation * active agvhd or uncontrolled infections within 60 days post-transplantation * cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy) * respiratory failure ( pao2 ≤60mmhg) * hepatic abnormalities (total bilirubin ≥3 mg/dl, aminotransferase \>2 times the upper limit of normal) * renal dysfunction (creatinine clearance rate \< 30 ml/min) * ecog performance status 3, 4 or 5 * with any conditions not suitable for the trial (investigators' decision)

Keywords: acute leukemia sorafenib relapse flt3-negative allogeneic hematopoietic stem cell transplantation
foot abnormalities in diabetic ckd patients

Conditions: CKD; Diabetic Foot

Summary: 1. to find the correlation between different stages of ckd and type and severity of foot abnormalities in diabetic patients with ckd. 2. to assess factors that may aggravate foot abnormalities in diabetic patients with ckd by measuring serum calcium, phosphorus, parathyroid hormone, albumin, uric acid...etc.

chronic kidney disease is an important contributor to morbidity and mortality, the global prevalence of ckd was 9.1% (697.5 million cases) in 2017(1). diabetes is a leading cause of end stage renal disease worldwide. (2) foot abnormalities and amputation are major health concerns as they diminish health-related quality of life and cause financial burden (3). kdigo 2020 defines chronic kidney disease (ckd) as persistently elevated urine albumin excretion (≥30 mg/g \[3mg/mmol\] creatinine), persistently reduced estimated glomerular filtration rate (egfr \<60 ml/min per 1.73 m2), or both, for greater than 3 months. (4) diabetic foot is defined as either diabetic peripheral neuropathy, peripheral arterial disease, infection, ulceration, or charcot osteoarthropathy, or a combination of these abnormalities, in a person diagnosed with diabetes mellitus, according to the guidelines of international working group of diabetic foot 2020 (iwgdf). (5) there is a much higher incidence of diabetic foot disorder in those with renal disease and outcomes are generally poorer (2) as ckd patients are sharing three main risk factors of foot ulceration and amputation: neuropathy, peripheral arterial disease and increased susceptibility to infection with impaired wound healing. (6) this research is conducted as little is known about the potential relationship between chronic kidney disease and diabetic foot. this research evaluates the true burden of different diabetic foot lesions in ckd patients, assesses the severity of diabetic foot in different stages of ckd and the factors that may aggravate it in ckd, for future need to modify our clinical policies in management of diabetic foot in ckd patients to provide better prognosis and prevent long term disabilities.

Eligibility criteria:
inclusion criteria: 1. diabetic ckd patients classified according to estimated gfr into 5 stages according to kidgo 2012 classification: stage 1 ckd: egfr 90 or greater stage 2 ckd: egfr between 60 and 89 stage 3 ckd: egfr between 30 and 59 stage 4 ckd: egfr between 15 and 29 stage 5 ckd: egfr less than 15 etheir on dialysis ( satge 5 d) or not (stage 5 non d) 2. age more than ≥18 years exclusion criteria: 1. patients administer drugs causing neuropathy as:amiodarone, chemotherapy, oxazolidinone linezolid, isoniazid, metronidazole, nitrofurantoin ,immunosuppressants, nucleoside reverse transcriptase inhibitors, levodopa and antifungal drugs. 2. patients with other causes of ckd. 3. patients have other causes of pvd. 4. age less than ˂18 years. 5. patients' refusal to participate in the study.
metabolic assessments of neurostimulation to reduce apnea

Conditions: Obstructive Sleep Apnea; Obstructive Sleep Apnea of Adult

Summary: hypoglossal nerve stimulation (hgns) is an implantable therapy that treats obstructive sleep apnea. the study will evaluate the effect of this treatment on metabolism-related outcomes and measures of inflammation to see if it lowers patients' risk of medical problems associated with obstructive sleep apnea (osa).


Eligibility criteria:
inclusion criteria: * english-speaking adults (18+ years) who have met surgical efficacy criteria with hgns, as defined by at least a 50% reduction in apnea-hypopnea index (ahi) to \<20 (with hypopneas defined by 4% oxyhemoglobin desaturations) * have been using hgns therapy for at least 3 months and used hgns for \>20 hours/week during the past 4 weeks * were not using any osa therapy for at least one month prior to hgns activation or have had a one-month period of untreated osa after hgns activation exclusion criteria: * chronic use of opiate medications, illicit drugs, or alcohol dependency * women who are pregnant or planning to become pregnant * shift workers, heavy machinery operators, or unable to avoid driving during the hgns withdrawal portion of the study (e.g. commercial drivers) * lack of a sleep study at their current hgns voltage within the last three years * history of severe excessive daytime sleepiness (epworth sleepiness scale score \>16 at time of screening or prior to hgns), motor vehicle accidents or near-miss incidents due to drowsy driving * significant cardiopulmonary (such as home oxygen requirement), liver, renal, or oncologic disease; neurodegenerative disease; active or recent history of an eating disorder (within the last 5 years) * inability to provide informed consent

Keywords: hypoglossal nerve stimulation inspire
bikini vs longitudinal incision in direct anterior approach (daa) total hip arthroplasty (tha)

Conditions: THA

Summary: the study team is conducting this study to see if there is a difference between the wound healing and participant satisfaction rates between two incision types used during a tha done via the daa technique.


Eligibility criteria:
inclusion criteria: * patients with body mass index greater than or equal to 30 * patients undergoing primary unilateral daa tha * patients undergoing primary tha exclusion criteria: * patients with body mass index less than 30 * patients with a history of prior open surgery on the affected hip * patients unable/unwilling to undergo spinal anesthesia under monitored anesthesia care (mac) * patients with allergies or absolute contraindication to standardized drugs administered within the university of miami protocol for total hip replacement * the following groups will not be included: adults unable to consent, individuals who are not yet adults, pregnant women, prisoners.
sexual dimorphism analysis in egyptian population by locating the mandibular canal using cbct

Conditions: Gender Identity

Summary: sexual dimorphism analysis in egyptian population by locating the mandibular canal using cone-beam computed tomography: an observational cross sectional study

many studies from different countries such as united states, china, japan, and europe were done to observe the distinct morphologic and morphometric manifestations of sexual dimorphism. accordingly, it is mandatory to target a specific population with their unique skeletal features.

Eligibility criteria:
inclusion criteria: * 18 years and above. * absence of large pathological lesions in mandible. * dentulous patients exclusion criteria: * patients younger than 18 years old * presence of large pathological lesions in mandible * completely edentulous patients.
laparoscopic versus open abdominal aortic aneurysm (aaa) exclusion

Conditions: Infra and Juxtarenal Abdominal Aortic Aneurysms

Summary: in many countries the gold standard for treating abdominal aortic aneurysms is still open surgery with a long incision. in patients with suitable anatomy alternatively an endovascular approach can be chosen. since open surgery is more durable in many countries a laparoscopic procedure using " key hole surgery " has gained wider acceptance. the current study wants to prove that laparoscopic aortic aneurysm procedures are less invasive than open surgery with reduced recovery times.

in many countries the gold standard for treating abdominal aortic aneurysms is still open surgery with a long incision. in patients with suitable anatomy alternatively an endovascular approach can be chosen. since open surgery is more durable in many countries a laparoscopic procedure using " key hole surgery " has gained wider acceptance. the current study wants to prove that laparoscopic aortic aneurysm procedures are less invasive than open surgery with reduced recovery times. study design: multi center prospective randomized study including patients with infra or juxtarenal aortic aneurysms ( aaa). in group i the aaa is resected using a conventional long incision and standard procedures for resecting the aaa. a dacron graft is used in inlay technique to restore blood flow. in group ii a total laparoscopic approach is chosen to exclude the aaa. identical to open surgery a dacron graft is laparoscopically sawn in to exclude the aaa and to restore blood flow. in a subgroup ii a the laparoscopic anastomosis is performed with a stapling device to simplify and to accelerate the procedure. endpoints of the study: total operating time, aortic crossclamping time, stay in icu, return to a regular diet,postoperative ileus, total hospital stay, major and minor complications, blood loss, renal function in cases with juxtarenal aaa.patients are evaluated for postoperative pain, wound related problems, hernias and time until full mobilisation is achieved. hypothesis: the laparoscopic approach though associated with a longer operating time and longer clamping times is associated with a reduced recovery time, les pain and less wound related problems compared to a full length conventional incision.

Eligibility criteria:
inclusion criteria: * patients with abdominal aortic aneurysms * fit for open surgery exclusion criteria: * patients unfit for open surgery * patients with malignancies

Keywords: abdominal aortic aneurysms
fluor varnish with silver nanoparticles for dental remineralization in patients with trisomy 21

Conditions: Down Syndrome

Summary: patients with trisomy 21 are in greater danger of developing caries. it has been hypothesized that adding silver nanoparticles to fluor varnishes could promote remineralization of the teeth. a split-plot randomized controlled trial will be performed to address this question.


Eligibility criteria:
inclusion criteria: * patients with trisomy 21 diagnosed through caryotype * age 1 to 6 years old * any sex * white spot present in both upper anterior teeth * parental agreement to participate in the study exclusion criteria: * hypersensibility to any of the substances used * non cooperating patients * caries in enamel or dentine in the upper anterior teeth * leukemia or diabetes * dental fluorosis present

Keywords: down syndrome caries dental varnish
efficacy and safety of pt003, pt005, and pt001 in subjects with moderate to very severe chronic obstructive pulmonary disease (copd); (pinnacle 1)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the overall objective of this study is to assess the efficacy and safety of treatment with pt003 (gff mdi), pt005 (ff mdi), pt001 (gp mdi), and open-label tiotropium bromide inhalation powder compared with each other and placebo mdi over 24 weeks in subjects with moderate to very severe copd.


Eligibility criteria:
key inclusion criteria: * male or female subjects at least 40 years of age and no older than 80 at visit 1. * subjects with an established clinical history of copd as defined by the american thoracic society (ats)/european respiratory society (ers) * current or former smokers with a history of at least 10 pack-years of cigarette smoking. * average f the -60 and the -30 min pre-dose fev1 assessments must be \< 80% predicted normal value calculated using national health and nutrition examination survey (nhanes) iii reference equations. * subjects willing and, in the opinion of the investigator, able to adjust current copd therapy as required by the protocol key exclusion criteria: * significant diseases other than copd, i.e. disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study * current diagnosis of asthma or alpha-1 antitrypsin deficiency * other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea * hospitalized due to poorly controlled copd within 3 months prior to screening or during the screening period * poorly controlled copd, defined as acute worsening of copd that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the screening period * lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the screening period * unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment. * recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months * congestive heart failure (chf) new york heart association (nyha) class iii/iv) * clinically significant abnormal 12-lead ecg * abnormal liver function tests defined as aspartate transaminase (ast), alanine transaminase (alt), or total bilirubin ≥ 1.5 times upper limit of normal at visit 1 and on repeat testing * cancer not in complete remission for at least five years * history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the mdi other protocol-defined inclusion/exclusion criteria may apply
effectiveness of orally dosed emergency contraception in obese women - lng

Conditions: Obesity

Summary: obese women are significantly more likely than their normal bmi counterparts to experience failure of orally-dosed emergency contraceptives. the pi's preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed emergency contraceptives in obese women. the overall project will be focused on both levonorgestrel (lng) - and ulipristal acetate-containing emergency contraception but this protocol registration is for the lng aspect of the study procedures.

emergency contraception (ec) provides a woman with an additional line of defense against unintended pregnancy following an act of unprotected intercourse. orally-dosed ec works by delaying ovulation and reduces the risk of pregnancy for a single act of unprotected intercourse by 50-70%. unfortunately, obese women are significantly more likely than their normal bmi counterparts to experience failure of orally-dosed ec and in some instances ec is equivalent to placebo. the pi's preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed ec in obese women. the hypothesis is that increasing the dose of orally-dosed ec agents will normalize the pharmacokinetics resulting in the expected treatment effect (delay in follicle rupture) in obese women. in the overall proposal, the investigators plan to perform detailed pharmacokinetic and pharmacodynamic studies of ulipristal acetate-based ec in obese women and expand upon the preliminary findings of levonorgestrel-based ec. this protocol registration is for the lng aspect of the study procedures focused on the pharmacodynamics of lng dose escalation

Eligibility criteria:
inclusion criteria: * generally health women * aged 18-35 years old * regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a progesterone level of 3ng/ml or greater. * subjects must have a bmi of \>30 kg/m2 and weigh at least 80 kg or more. exclusion criteria: * metabolic disorders including uncontrolled thyroid dysfunction and polycystic ovarian syndrome * impaired liver or renal function * actively seeking or involved in a weight loss program (must be weight stable) pregnancy, breastfeeding, or seeking pregnancy * recent (within last 8 weeks) use of hormonal contraception * current use of drugs that interfere with metabolism of sex steroids * smokers.

Keywords: obesity body weight emergency contraception levonogestrel ulipristal acetate
a telehealth advance care planning intervention in those with mild cognitive impairment or unrecognized dementia

Conditions: Advance Care Planning; Telemedicine; Mild Cognitive Impairment; Unrecognized Dementia; Dementia

Summary: the purpose of this study is to pilot test a telehealth advance care planning (acp) intervention among those with either mild cognitive impairment (mci) or unrecognized dementia. our goal is to pilot-test and evaluate a pragmatic telehealth acp intervention among patients with either the diagnosis of mild cognitive impairment (mci) or unrecognized dementia.

telehealth has the potential to overcome barriers related to timing and travel restraints and to provide patients and their caregivers with an opportunity to discuss their goals, values, and priorities for their healthcare within their home setting. recent studies have demonstrated patients' willingness to use telehealth and have shown that it can play an integral role in dementia care management.

Eligibility criteria:
inclusion criteria: * diagnosis of recognized or probable mild cognitive impairment (mci) or mild dementia determined by either icd10 diagnostic codes or electronic health record (ehr) risk of alzheimer's and dementia assessment rule (eradar) * have decisional capacity according to their primary care physician (pcp) to complete acp * completed visit with their pcp within the past 12 months * affiliated with an accountable care organization. * english-speaking exclusion criteria: * moderate to severe hearing loss that would preclude participating in a video or telephone intervention * no phone number available for patient. * lives in a long-term care facility

Keywords: dementia telehealth advance care planning mild cognitive impairment
phenotype and multi-omics analysis of children with congenital diarrhea and enteropathy in china

Conditions: Diarrhea Infantile

Summary: this study will establish a clinical cohort of children with congenital diarrhea and enteropathy (code), mine biomarkers of code through multi-omics technology and construct a clinical risk prediction model.

this study will establish a clinical cohort and a clinical phenotype database of children with congenital diarrhea and enteropathy (code), the investigator will mine biomarkers of code through multi-omics technology. this study is designed to construct a clinical risk prediction model by combining artificial intelligence technology.

Eligibility criteria:
inclusion criteria: * patients with chronic diarrhea lasting greater than 2 months or greater than 1 month in patients younger than 2 months of age * patients with consent from parents or legal guardians exclusion criteria: * chronic diarrhea caused by specific infections, i.e. cmv, clostridioides difficile * chronic diarrhea with necrotizing enterocolitis, short bowel syndrome * functional diarrhea * patients with poor compliance