Kornimate/medical-research-clean huggingface dataset:
study of a postpartum diabetes prevention program for hispanic women

Conditions: Diabetes

Summary: the overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce risk factors for type 2 diabetes and cardiovascular disease among postpartum hispanic women with a history of abnormal glucose tolerance during pregnancy.

specific aims are to evaluate the impact of the intervention on 1) postpartum weight loss, 2) biomarkers associated with insulin resistance (i.e., glucose, insulin, hba1c, leptin, tnf-α, homa, aucgluc, adiponectin), 3) other cardiovascular risk factors (i.e., blood lipids, blood pressure, crp, fetuin-a, albumin-to-creatinine ratio), and 4) the adoption and maintenance of postpartum behaviors associated with weight loss and prevention of diabetes risk (i.e., physical activity, diet). eligible hispanic women will be recruited after routine gdm screening and randomly assigned to a lifestyle intervention (n=150) or a comparison health and wellness (control) intervention (n=150). the intervention will be based on our efficacious exercise and dietary interventions for hispanics (r01nr011295; wic common pathways). multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) will be used to deliver the intervention from randomization (29 wks gestation) to 12 months postpartum. targets of the intervention are to achieve institute of medicine guidelines for postpartum weight loss; american college of obstetrician and gynecologist guidelines for physical activity; and american diabetes association guidelines for diet. the intervention draws from social cognitive theory and the transtheoretical model and addresses the specific social, cultural, economic, and physical environmental challenges faced by underserved hispanic women. measures of adherence will include the pregnancy physical activity questionnaire (ppaq), accelerometers, and dietary recalls. the project is a renewal application of r01 dk064902, a study of lifestyle risk factors for gdm in hispanic women. the proposed project builds upon the expertise of the investigative team in conducting randomized controlled trials of lifestyle interventions among hispanic pregnant women (r01 dk074876; s3948 asph/cdc) and controlled trials of lifestyle interventions among low-income hispanics with type 2 diabetes and pre-diabetes (r18 dk0658850; r18dk067549) and can readily be translated into clinical practice in underserved and minority populations.

Eligibility criteria:
inclusion criteria: * hispanic women with one or more glucose values during the diagnostic test meeting or exceeding the thresholds defined according to the american diabetes association exclusion criteria: * history of type 1 or type 2 diabetes, heart disease, or chronic renal disease * contraindications to postpartum participation in moderate physical activity or a low-fat/high-fiber diet (e.g., crohn's disease, ulcerative colitis) * inability to read english or spanish at a 6th grade level * \ 45 yrs of age * women carrying multiples
metoclopramide, dexamethasone or axoli to prevent or delay chemotherapy-induced nausea and vomiting in moderately emetogenic non-ac-based chemotherapy

Conditions: Solid Tumors

Summary: in this phase iii non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed chemotherapy-induced nausea and vomiting (cinv) induced by non- anthracyclines plus cyclophosphamide (ac) based moderately emetogenic chemotherapy (mec).


Eligibility criteria:
inclusion criteria: * patient has been diagnosed with histologically or cytologically confirmed solid cancer * starting with first cycle of chemotherapy of moderate emetogenic risk, which does not include a combination of anthracycline plus cyclophosphamide * age ≥ 18 * who ≤ 1 * patient is able to understand and speak dutch exclusion criteria: * patient with nausea and/or vomiting in 48 hours before start of chemotherapy treatment * patient submitted to concomitant radiotherapy or submitted to radiotherapy 15 days before start of chemotherapy or planned to receive radiotherapy during 8 days after administration of chemotherapy * patient with concomitant severe comorbidy, such as: o intestinal obstruction o active peptic ulcer o hypercalcemia o uncontrolled diabetes mellitus o pheochromocytoma o tardive dyskinesia o epilepsia o active infective diseases o brain - or leptomeningeal metastases o psychiatrical disorders o parkinsonism * current use of corticosteroids (similar to prednisone ≥ 10 milligrams per day) * current alcohol abuse * pregnancy
postoperative kidney functions in geriatric major gynecologic-oncologic surgery

Conditions: Geriatrics; Acute Renal Injury; Gynecologic Surgery

Summary: the increasing number of patients who develop perioperative acute kidney injury (aki) is partly related to the aging population and the increasing number of individuals with chronic comorbidities, particularly those with premorbid chronic kidney disease. anesthesiologists and surgeons will increasingly have to deal with such patients who are elderly and have comorbidities and require major surgery. the aim of this study was to determine the incidence of postoperative acute kidney injury (primary aim) in patients aged 65 and over who underwent elective major gynecological-oncological surgery under general anesthesia in ankara city hospital gynecology-oncology operating room between january 2020-2022 and were followed up in the pacu in the postoperative period. to investigate risk factors and their results in a retrospective manner in line with the kdigo criteria (secondary purpose).


Eligibility criteria:
inclusion criteria: * patients underwent major abdominal gynecologic oncologic surgery between january 2021 and january 2022 * followed in the pacu exclusion criteria: * patients with inaccessible data and missing data

Keywords: geriatrics acute renal injury gynecologic surgery
assessing the efficacy of four drug combinations as the next first-line therapy for uncomplicated malaria in malawi

Conditions: Malaria, Falciparum

Summary: sulfadoxine-pyrimethamine (sp) is the current first-line treatment for uncomplicated malaria in malawi. the malaria parasite p. falciparum has developed resistance to this drug so that the drug is much less effective than in previous years. this study was developed and conducted in collaboration with the national malaria control programme of malawi to assess the efficacy of four antimalarial drug combinations to provide evidence to assist the malawian ministry of health in identifying and implementing as policy the next first-line antimalarial for uncomplicated malaria in malawi. in an open, randomized trial in children under five years of age, four drug combinations, all of which are licensed in malawi, are being assessed: amodiaquine plus sulfadoxine-pyrimethamine (aq-sp), amodiaquine plus artesunate (aq-art), chlorproguanil-dapsone plus artesunate (cd-art) and lumefantrine-artemether (la). sp is also included as a fifth arm of the study for current data on its efficacy. data on side effects of the drugs will also be collected. the results of this study will provide some of the information necessary to guide the malawi national malaria control program in selecting its next first antimalarial treatment for uncomplicated malaria. the study adheres to the world health organization's 2003 standardized protocol for assessing antimalarial drug efficacy.


Eligibility criteria:
inclusion criteria: * children age 6 - 59 months * axillary temperature ≥ 37.5 °c * monoinfection with p. falciparum * parasitaemia between 2000 - 200000 parasites/µl * haemoglobin concentration (finger-prick blood sample by hemocue) \> 7g/dl * consent by the patient's adult guardian * residence in the locality and willingness to attend for scheduled visits exclusion criteria: * altered consciousness * convulsions * prostration (inability to sit/stand/suck/drink) * respiratory distress or breathlessness * jaundice * abnormal breathing * haemoglobinuria * circulatory collapse * persistent vomiting (cannot keep down liquids) * evidence of a diagnosis other than malaria on physical examination * presence of mixed infection * presence of severe malnutrition (as evidenced by symmetrical oedema involving at least the feet, light hair color, or cachexia) * contraindications to the antimalarial drugs used, especially history of allergy * history of receiving a drug with antimalarial activity in the week prior to enrollment

Keywords: antimalarials
icotinib for completed resected ib nsclc with egfr mutation

Conditions: Lung Neoplasms; Squamous Cell Lung Cancer; Adenocarcinoma of the Lung; Adenosquamous Cell Lung Cancer; Large Cell Lung Cancer; Bronchial Neoplasms; Stage IB Non-small Cell Lung Cancer

Summary: this phase ii trial studies how well icotinib works in treating patients with completely resected stage ib nsclc harboring egfr mutation.

adjuvant chemotherapy have shown little evidence of survival benefit in patients with stages ib non-small cell lung cancer (nsclc) after complete resection. epidermal growth factor receptor tyrosine kinase inhibitors (egfr-tkis) show great efficacy in patients with egfr mutant non-small cell lung cancer (nsclc). icotinib is a novel egfr-tki developed by a group of chinese scientists and clinician. in the phase iii icogen trial, icotinib had non-inferiority efficacy to gefitinib with better safety. this study is studying icotinib to see how well it works in treating patients with fully resected stage ib nsclc harboring egfr mutation.

Eligibility criteria:
inclusion criteria: * written informed consent provided. * males or females, aged 18-75 years. * able to comply with the required protocol and follow-up procedures, and able to receive oral medications. * had completely resected pathological confirmed stage iia-iiia nsclc. * egfr activating mutation in exon 19 or 21. * patient who can start the investigational therapy within 3-6 weeks after the complete resection. * ecog performance status of 0-1. * had a life expectancy of 12 weeks or more. * adequate hematological function, adequate liver function and renal function. * female patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test. exclusion criteria: * had had previous chemotherapy, radiotherapy, or agents directed at the her axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab). * inability to comply with protocol or study procedures. * had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder. * any evidence confirmed tumor recurrence before investigational therapy. * known severe hypersensitivity to icotinib or any of the excipients of this product. * evidence of clinically active interstitial lung disease. * eye inflammation not fully controlled or conditions predisposing the subject to this. * any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). * known human immunodeficiency virus (hiv) infection. * pregnancy or breast-feeding women. * ingredients mixed with small cell lung cancer patients. * history of neurologic or psychiatric disorders.
repeated versus varied simulation scenarios to teach medical students the management of a pediatric asthma exacerbation

Conditions: Education, Medical

Summary: repeated exposure to simulated cases has been shown to improve performance, but repeating the same scenario may impair the ability of learners to transfer their knowledge and skills to slightly different situations. the objective of this study is to compare the use of repeated versus varied simulation cases for teaching the management of pediatric asthma exacerbation to 3rd year medical students.


Eligibility criteria:
inclusion criteria: * third year medical students from paris descartes and paris diderot medical faculties. * who are not opposed to participated in the study exclusion criteria: * opposition to participate in the study

Keywords: education, medical simulation training
investigation the safety and efficacy of the antileukotriene agents, montelukast, as adjuvant therapy in obese patients with type 2 diabetes mellitus

Conditions: Obesity; Endocrine; Diabetes Type 2

Summary: the aim of the current study is to evaluate the safety and efficacy of montelukast in treatment of obese patients with type 2 diabetes (t2dm).


Eligibility criteria:
inclusion criteria: - type 2 diabetic patients who had body mass index (bmi) ≥ 30 kg/m2 , were treated with metformin alone and had ages ranging from 18 to 60 years. exclusion criteria: * patients who had any other inflammatory disease * patients with cardiovascular, * patients with asthma * patients with severe hepatic * patients with renal disease, * patients with epilepsy * pregnant or lactating females.
effect of tourniquet application on postoperative functional outcome following total knee arthroplasty

Conditions: Osteoarthritis

Summary: a pneumatic tourniquet is often used during total knee arthroplasty. however, its effect on postoperative outcomes as soft tissue damage resulting in delayed recovery remains unclear. the purpose of the present study was to compare tourniquet use versus non-tourniquet use during total knee arthroplasty for short-term functional recovery.

in a prospective cohort design, consecutive series of patients who underwent primary unilateral total knee arthroplasty (tka) in the bergman clinic, the netherlands were investigated. patients scheduled for primary tka due to osteoarthritis, age between 50 and 75 years and with dutch language proficiency were eligible for inclusion. exclusion criteria were inflammatory arthritis, severe cardiac complaints, severe pulmonary disorders, body mass index (bmi) \>35, severe coagulation disorders or hospitalization in the previous two months before surgery. each patient included in the study signed informed consent. the research protocol was approved by the regional ethics committee vcmo in nieuwegein, the netherlands, registration number w13.022.

Eligibility criteria:
inclusion criteria: * scheduled tka due to osteoarthritis * age between 50 and 75 years * dutch language proficiency * signed informed consent exclusion criteria: * inflammatory arthritis * severe cardiac complaints * severe pulmonary disorders * body mass index \>35 * severe coagulation disorders * hospitalization in the previous two months before surgery

Keywords: tourniquet postoperative outcome total knee arthroplasty
study of intralesional cemiplimab in adult patients with early stage cutaneous squamous cell carcinoma

Conditions: Cutaneous Squamous Cell Carcinoma (CSCC)

Summary: this study will test a study drug called cemiplimab to see if it can help treat early-stage cutaneous squamous cell carcinoma (cscc), a type of skin cancer. cemiplimab works by helping the immune system to kill cancer cells. it binds to a protein called programmed cell death-1 (pd-1) on the surface of certain immune cells. the main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion. the study is looking at: * the side effects cemiplimab might cause * how well cemiplimab works


Eligibility criteria:
key inclusion criteria: 1. participants who have a histologically confirmed invasive cscc tl, as described in the protocol 2. participants who have cscc tl ≥1 cm and ≤2.0 cm (longest diameter) located in either the head or neck (hn), hand, or pre-tibial surface, as described in the protocol 3. participants who are judged to be eligible for surgical resection of their cscc tl and the method of planned surgical resection would be micrographically oriented histographic surgery (mohs) or other surgical method of complete margin assessment (cma). participants for whom the planned surgery is surgical excision without margin control are not eligible 4. eastern cooperative oncology group (ecog) performance status (ps) ≤1 5. adequate hepatic, renal and bone marrow functions, as described in the protocol key exclusion criteria: 1. participant in which the tl is a keratoacanthoma (ka), adenosquamous carcinoma, desmoplastic carcinoma, basal cell carcinoma, basosquamous.carcinoma, bowen's disease, or cscc in situ without an invasive component. (note: for participants with invasive cscc with a minor basaloid component, the patient may be eligible after discussion with the sponsor medical director.) 2. ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (imaes), as described in the protocol 3. history of non-infectious pneumonitis within the last 5 years 4. tl (lesion planned for intralesional therapy) or other non-target cscc lesion in dry red lip (vermillion), oral cavity, or nasal mucosa note: other protocol defined inclusion / exclusion criteria apply.

Keywords: dermato-oncology cemiplimab early stage skin cancer non-melanoma skin cancer uv skin damage chronic sun exposure
a 12-week study in participants with refractory chronic cough (mk-7264-012)

Conditions: Refractory Chronic Cough

Summary: this study is designed to evaluate the efficacy of three dose regimens of gefapixant (\[mk-7264\] 7.5 mg, 20 mg, and 50 mg) relative to placebo in reducing awake objective cough frequency. the primary hypothesis for this trial is that at least one dose regimen of gefapixant is superior to placebo with respect to the mean change from baseline in awake cough frequency (on the log scale).


Eligibility criteria:
inclusion criteria: * women and men between 18 and 80 years of age inclusive * have refractory chronic cough * women of child-bearing potential must use 2 forms of acceptable birth control - have provided written informed consent. * are willing and able to comply with all aspects of the protocol exclusion criteria: * current smoker * forced expiratory volume in 1 second (fev1)/forced vital capacity (fvc) ratio \<60% * history of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the baseline visit * history of opioid use within 1 week of the baseline visit * body mass index (bmi) \<18 kg/m\^2 or ≥ 40 kg/m\^2 * history of concurrent malignancy or recurrence of malignancy within 2 years prior to screening (not including subjects with \<3 excised basal cell carcinomas) * screening systolic blood pressure (sbp) \>160 mm hg or a diastolic blood pressure (dbp) \>90 mm hg * clinically significant abnormal electrocardiogram (ecg) at screening * significantly abnormal laboratory tests at screening * pregnant or breastfeeding * other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator or sponsor, would make the participant inappropriate for entry into this trial
variation igfbp7 markers and timp2 induced by injection of contrast iodized drug at the intensive care patient

Conditions: Emergency

Summary: multicenter, prospective, uncontrolled study to evaluate variations in urinary concentrations of timp-2 and pci igfbp7 induced injection during a ct scan in intensive care patient.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or more, * hospitalized in intensive care, * holders of a urinary catheter * patient receiving a first ct with intravenous injection of pci during their icu stay. * patient agreeing to participate in the research protocol exclusion criteria: * anuria * need to retain urine, whatever the reason (eg measurement of 24-hour proteinuria). * urine unanalyzable whatever reason (eg urinary washing with double current probe, injection is saline to measure bladder pressure.). * patient subjected to renal replacement * patient already included in the study for a previous injection of pci in intensive care.
plant exosomes +/- curcumin to abrogate symptoms of inflammatory bowel disease

Conditions: Irritable Bowel Disease

Summary: the trial will test the hypothesis that edible structures within plant cells (ginger) will have clinically important anti-inflammatory effects on the gut lining of patients with inflammable bowel disease. to evaluate the safety and tolerability of exosomes with and without curcumin in patients with inflammatory bowel disease (ibd); to estimate the effect of ginger exosomes or curcumin alone or combined with curcumin on the symptoms and disease score in patients with refractory ibd describe toxicities associated with ginger exosomes; to evaluate the effect of ginger exosomes on biomarkers of inflammation.

up to 90 patients with chronic ibd will be enrolled, with the goal of having three arms of 30 subjects in each group who are eligible for evaluation. this exploratory trial is designed to estimate the effect of ginger exosomes or curcumin on ibd symptoms compared to ginger exosomes plus curcumin. in this prospective and randomized study the main focus is to compare exosomes alone, curcumin, and exosomes plus curcumin. three primary stratification factors race (white and black), gender and type of ibd (cd and uc) will be used. plan zelen's (1974) method will be used to avoid imbalance allocation within each stratum. a block size of 4 will be used. we plan to enroll all eligible patients visiting the clinic, as well as eligible patients referred from other gastroenterologists. all eligible visiting our clinic will be enrolled. by enrolling consecutive patients, we reduce selection bias. a patient will be enrolled only once. the most important aim of this study is to compare the ibd symptoms in exosomes alone and exosomes plus curcumin groups of patients. the symptomatology will be measured in each group and compared to the self-reported score. we will use the incidence rate of bloody stool to justify the sample size. with the combination treatment (ginger exosomes plus curcumin as compared to curcumin alone) we hope to reduce symptoms by at least 30%. using a two sample one-sided t test for comparing mean differences in inflammatory bowel disease questionnaire, with 30 subjects in each group and using alpha=5%, we will have 80% power to detect effect size of 0.65 standard deviation, which is a large effect size (cohen, 1988).. when the reduction in sample size due to missing data or other reasons, we will have reduced power to detect the difference in two groups.

Eligibility criteria:
inclusion criteria: * patients must have a confirmed diagnosis of ibd (either cd or uc) with moderate disease activity.) * ability to independently care for oneself exclusion criteria: * pregnancy * known hiv * patients receiving immunosuppressive drugs, other than for their bowel disease * patients must be on stable doses of their medications for the 2 weeks prior to study entry and for the duration of the treatment period, or inform the investigator of any changes in medication * active malignancy in the last 5 years * patients receiving any other investigational agent(s) * ginger allergy