Kornimate/medical-research-clean huggingface dataset:
neuromuscular blockade in patients with severe renal impairment

Conditions: Neuromuscular Blockade; Renal Impairment

Summary: this study is intended to be a single-site, prospective, randomized, double-blinded study that intends to enroll a total of 60 patients with severe renal impairment undergoing surgery with general endotracheal anesthesia at parkland hospital. patients will be randomized to receive either neostigmine (for reversal of cisatracurium) or sugammadex (for reversal of rocuronium). a standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. the remainder of the anesthetic care of the subject will not deviate from the standard of care. all patients will be monitored with continuous pulse oximetry postoperatively for 24 hours.

this will be a prospective, randomized, double-blinded study of surgical patients with severe renal impairment that seeks to address the following: specific aim: to determine whether rocuronium-induced moderate neuromuscular blockade and reversal with sugammadex achieves recovery of neuromuscular function (tof ≥ 0.9) faster than reversal of cisatracurium-induced moderate neuromuscular blockade and reversal with neostigmine in patients with severe renal impairment. primary hypothesis: patients with severe renal impairment who are reversed with sugammadex after rocuronium will achieve a tof ≥0.9 within a time frame that is one-third of the time it takes for reversal with neostigmine after cisatracurium.

Eligibility criteria:
inclusion criteria: * 18-80 years old * severe renal impairment (crcl \< 30 ml/min) * undergoing non-emergent surgery that requires neuromuscular blockade * planned extubation in the operating room immediately after surgery * american society of anesthesiologists (asa) physical status classification 3 to 4 * willing and able to consent in english or spanish * no personal history of neuromuscular disease exclusion criteria: * age less than 18 or older than 80 * patient does not speak english or spanish * planned postoperative intubation/ventilation * allergy to sugammadex, neostigmine, glycopyrrolate, cisatracurium, or rocuronium * family or personal history of malignant hyperthermia * patient refusal * pregnant or nursing women * "stat" (emergent) cases * pre-existing muscle weakness of any etiology * patients on toremifene (a selective estrogen receptor modulator) * women on oral contraceptives who do not wish to use a non-hormonal method of contraception for 7 days following surgery
pre-pregnancy lifestyle intervention to prevent the recurrence of gestational diabetes in overweight and obese women

Conditions: Gestational Diabetes Mellitus

Summary: the overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women with overweight or obesity.


Eligibility criteria:
inclusion criteria: * prior diagnosis of gestational diabetes. * bmi \> 25 kg/m2 * planning to have a baby in the next 1-3 years * english or spanish speaking exclusion criteria: * age less than 18 years * women with type 2 or type 1 diabetes * current pregnancy * relocating in the next 2 years * medications that affect weight/diabetes * serious current physical disease * history of eating disorders * history of bariatric surgery * current problems with drug abuse * current treatment of a serious psychological disorder

Keywords: gestational diabetes prevention
efficacy of oral semaglutide in overweight or obesity

Conditions: Obesity; Weight Loss

Summary: all the eligible participants after screening will be randomized into two groups (group 1 and 2) by block randomization (block size of 4 and 6) using computer generated random number. randomization is performed by the individual not involved in the study. participants in both groups will receive individual counselling sessions to help them adhere to a reduced-calorie diet (500-kcal deficit per day relative to the energy expenditure estimated at the time) and increased physical activity (with 150 minutes per week of physical activity, such as walking). both diet and activity will be recorded daily in a diary or by use of a smartphone application or other tools and were reviewed during counselling sessions. participants in group 1 also receive oral semaglutide along with diet and exercise. treatment will be initiated with the 3 mg once-daily dose. the dose will be increased to 7 mg and then maximum of 14mg per day in 2-4weeks interval based on patient tolerance. dose escalation schedule will be used to decrease the gastrointestinal side effects. participants will be assessed for gastrointestinal complaints (nausea, vomiting) during escalation and follow-up. once the desired dose is achieved, patient will remain at the maximum 14mg daily dose unless a reduction was warranted owing to problems with side effects. in such cases, investigators will reescalate the dose once symptoms are resolved or diminished.the absorption of oral semaglutide is affected by food and fluid in the stomach, hence patients receiving oral semaglutide will be instructed to take each tablet with up to 120 ml of water in the morning, in a fasting state, and a minimum of 30 min before the first meal of the day. counselling will be done by a dietician or a similar qualified healthcare professional every 4th week via visits/phone contacts till the completion of the study. participants have to physically visit the hospital at the end of 28 weeks for assessment.


Eligibility criteria:
inclusion criteria: * consecutive consenting patients of both genders with either a bmi of 30 or greater or a bmi of 27 or greater with one or more treated or untreated weight-related coexisting conditions (i.e., prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease). exclusion criteria: * • diabetes mellitus * a glycated haemoglobin level of 48 mmol per mole (6.5%) or greater, * a history of chronic pancreatitis * acute pancreatitis within 180 days before enrolment * previous surgical obesity treatment * use of antiobesity medication within 90 days before enrolment * pregnancy and planning for pregnancy * known malignancy
effect of bydureon on carotid atherosclerosis progression in type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: investigators will be determining whether a once weekly injectable medication bydureon versus placebo is able to reduce the development of atherosclerosis. investigators are testing the overall hypothesis that 18 months of bydureon treatment will improve cardiovascular risk factors, endothelial function and retard carotid atherosclerosis plaque progression in type 2 diabetes mellitus (t2dm). investigators anticipate these studies will provide novel information about the temporal relationship between bydureon induced changes in risk factors, endothelial function and atherosclerosis progression.

148 typical t2dm patients (ages 21-75) will participate in a rolling recruitment over approximately 2.25 years and be randomly allocated for 18 months to bydureon (2 mg/week) or matching placebo subcutaneous injections 1x/week in a 2:1 ratio. participants are expected to have a wide range of cardiovascular (cvd) risk and will therefore allow us to explore the importance of disease extent at baseline as a predictor of response. blocked randomization will be used to ensure equal distribution of gender and cvd history. carotid plaque mri assessments will be performed at baseline, 9 and 18 months.

Eligibility criteria:
inclusion criteria: * males and females of any race and ethnicity with t2dm, hba1c of ≥6.5% and ≤10.0% on diet only * take stable doses of oral antihyperglycemic agents with or without long-acting insulin * must have a regular primary care provider (pcp) that is amenable to patient study participation and will facilitate (blinded to the treatment) the research team's study protocol efforts exclusion criteria: * type 1 diabetes mellitus (t1dm) * current or recent glucagon-like peptide 1 receptor (glp-1r) agonist use * contraindications to mri (e.g., claustrophobia, ferromagnetic materials, body habitus inappropriate for mri exam) * screening carotid ultrasound plaque thickness of \<0.75 mm, prior or anticipated carotid stenting or endarterectomy * recent cvd (past 6 months) or other major illness or conditions affecting risk (e.g., pancreatitis, severe renal disease) or personal or family history of medullary thyroid carcinoma * patients with multiple endocrine neoplasia syndrome type 2 * serious hypersensitivity to exenatide or any product components * severe gastrointestinal disease, or pregnancy

Keywords: type 2 diabetes cardiovascular disease hyperglycemia carotid plaque endothelial function incretins atherosclerosis
immunogenicity of a live attenuated chimeric je vaccine (imojev) as a booster dose in thai children primed with cd.jevax

Conditions: Encephalitis

Summary: this study was undertaken to assess the immunogenicity and safety of a booster dose of a live attenuated chimeric japanese encephalitis vaccine (je-cv) after primary vaccination with sa14-14-2 in thai children aged 1 to \<5 years. in addition, to assess the impact of the duration interval after primary vaccination on subsequent booster response.

the subject will receive one booster dose of imojev with hepatitis a vaccine (inactivated vaccine of glaxosmithkline) as concomitant vaccine. blood samples will be collected to assess for japanese encephalitis neutralizing antibody at baseline (pre-vaccination) and 4 week post -vaccination.

Eligibility criteria:
inclusion criteria: * children aged 1 to \<5 years on the day of inclusion * history of received 1 dose of cd.jevax at 9-15 months prior to enrollment * in good general health at the time of inclusion * provision of informed consent by the parent(s) or legal guardian(s) exclusion criteria: * receipt of blood or blood products in the past 3 months * acute febrile illness on the day of vaccination (body temperature ≥ 38 ◦c) * previous receipt of 2 doses of any vaccine against je virus * known hypersensitivity to any of the vaccine components * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * planned receipt of any live attenuated vaccine within 4 weeks following the trial vaccination

Keywords: live attenuated japanese encephalitis vaccine imojev cd.jevax booster thai children immunogenicity safety interchangeability hepatitis a vaccine vaccination or other immunization procedure
omniheart trial: macronutrients and cardiovascular risk

Conditions: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Hypertension

Summary: to compare the effects on blood pressure and plasma lipids of three different diets--a carbohydrate-rich diet, a protein-rich diet, or a diet rich in unsaturated fat.

background: while there is widespread consensus that the optimal diet to reduce cardiovascular risk should be low in saturated fat, the type of macronutrient that should replace saturated fat (carbohydrate, protein or unsaturated fat) is a major, unresolved research question with substantial public health implications. the study will evaluate these three dietary approaches by studying their effects on established coronary risk factors and a selected group of emerging risk factors. design narrative: the study design was a randomized, three period cross-over feeding study that compared the effects on blood pressure and plasma lipids of a carbohydrate-rich diet patterned after the dash diet (carb) to two other diets, one rich in protein (protein) and another rich in unsaturated (unsat) fat, predominantly monounsaturated fat. the dash diet has been shown to reduce blood pressure and ldl-cholesterol substantially, and is currently recommended by policy makers. during a one week run-in, all participants were fed samples of the three study diets (carb, protein and unsat). using a three period cross-over design, participants were then randomly assigned to the carb, protein or unsat diet. each feeding period lasted six weeks; a washout period of at least two weeks separated each feeding period. throughout feeding (run-in and the three intervention periods), participants were fed sufficient calories to maintain their weight. trial participants were 30 years of age or older, with systolic blood pressure of 120-159 mmhg or diastolic blood pressure of 90-99 mmhg. primary outcomes variables were blood pressure and the established plasma lipid risk factors (ldl-c, hdl-c and triglycerides). secondary outcomes include total cholesterol, apolipoproteins vldl-apob, vldl-apociii, apolipoprotein b, non-hdl cholesterol, and lipoprotein(a).

Eligibility criteria:
inclusion criteria: * healthy adults * aged 30 years and older * systolic blood pressure of 120 to 159 mm hg or a diastolic blood pressure of 80 to 99 mm hg. exclusion criteria: * diabetes * active or prior cardiovascular disease (cvd) * ldl cholesterol greater than 220 mg/dl (\>5.70 mmol/l) * fasting triglycerides greater than 750 mg/dl (\>8.48 mmol/l) * weight more than 350 lb (\>159 kg) * taking medications that affect blood pressure or blood lipid levels * unwillingness to stop taking vitamin and mineral supplements * alcoholic beverage intake of more than 14 drinks per week.
day to day variation in fetal heart rate variability

Conditions: Fetal Growth Retardation

Summary: this study evaluates the day-to-day variation in fetal heart rate variability based on non-invasive fetal-ecg (ni-fecg). furthermore, the effect of fetal movements on fetal heart rate variability will be assessed.


Eligibility criteria:
inclusion criteria: * healthy singleton pregnant women with an expected healthy fetus exclusion criteria: * fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor. low birth weight or malformation diagnosed at birth.
safety study of combined immunotherapy with trastuzumab and cetuximab in patients with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: one important approach to change the natural history of advanced breast cancer is that of designing new combination chemotherapies in which the best drugs already available are used together with new anticancer agents devoid of clinical cross-resistance. the possibility of exploiting the combined use of cetuximab and trastuzumab represents an option of potential great impact on the probability of response and long-term therapeutic results for patients with advanced breast cancer and her2 overexpression.therefore, patients with tumors that demonstrate egfr expression and clear-cut erbb-2 overexpression (3+) or limited erbb-2 overexpression (+ or 2+) will be included in the study. patients will be treated with trastuzumab and cetuximab to study the pharmacokinetics and potential drug/drug interaction of both antibodies as well as the safety and tolerability of this novel combination treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of metastatic breast cancer * presence of at least 1 measurable lesion according to modified recist criteria * evidence (fluorescence in situ hybridization fish) of * her-2 overexpression in tumor tissue:group a: her-2 +++, group b: her-2 + or ++ * egfr-expressing disease as assessed by immunohistochemistry * recovered from relevant toxicities from other treatment prior to study entry exclusion criteria: * prior treatment with trastuzumab for metastatic breast cancer (adjuvant therapy is allowed) * prior treatment with cetuximab * concomitant cytotoxic chemotherapy * treatment with any investigational agent(s) within 4 weeks prior to study entry * known allergic/hypersensitivity reaction to any of the components of study treatments * severe dyspnea * myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder despite treatment * history of significant neurologic or psychiatric disorders
valo-2: study evaluating the safety and efficacy of ptx022 in the treatment of adults with pachyonychia congenita

Conditions: Pachyonychia Congenita

Summary: valo-2 is a multicenter, open-label extension (ole) study enrolling patients with genotyped keratin mutations krt6a, krt6b and krt16 who were previously treated with investigational ptx-022 during the valo study. the purpose of the ole study is to investigate long term exposure to investigational ptx-022 and evaluate safety and efficacy data. a sub-study is included to evaluate safety and efficacy of patients with genotyped keratin mutations of krt6c and krt17 not previously treated with investigational ptx-022.


Eligibility criteria:
key inclusion criteria: * adult patients 18 years or older, * previously completed the valo protocol, or valo-2 k6c/17 sub-study, and received meaningful benefit from investigational ptx-022 as determined by the clinician. key exclusion criteria: * any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications or to ptx-022
a cross-cultural assessment of the motivations of healthy participants in phase i research

Conditions: Healthy Volunteer

Summary: background: * individuals often participate in clinical trials to seek new therapies and free medical treatments for their illnesses or chronic conditions. however, less is known about the motivations of the healthy individuals who volunteer for research studies. * although many healthy volunteers participate in clinical trials for financial compensation, the particular risks involved in testing drugs that have not been tried in human clinical trials pose potential dangers for healthy volunteers in phase i studies. more research is needed to understand the motivations of volunteers who participate in phase i clinical trials. objectives: - to evaluate the primary and secondary motivations of healthy participants in research studies. eligibility: - individuals at least 18 years of age who are healthy volunteers in selected pfizer phase i clinical trials. design: * individuals who express interest in participating in specific pfizer phase i drug studies will be asked to complete a short questionnaire after completing the standard consent session for the study. * those who enroll in the trial will be asked to complete a second questionnaire prior to discharge from the study.

this healthy volunteer motivation study is a sub-study of phase i drug development studies conducted by pfizer international. the substudy is designed to evaluate the primary and secondary motivations of healthy participants in research studies, as well as the process by which participants decide to participate, including their consideration of any risks, benefits, compensation and other factors, and the relationship of these factors to cultural and sociodemographic variables. data will be collected via self-administered surveys at 2 possible time points, 1) after going through the consent process at the beginning of participation in the primary study, and 2) towards the end of the study participation.

Eligibility criteria:
* inclusion criteria: participants will be willing adults who have participated in an informed consent session for a designated phase i study at a pfizer cru. participants in new haven and singapore must be able to read and answer question in english and participants in brussels must be able to read and answer questions either in english, french, or flemish. only adults (over 18 years old) who can provide their own consent will be included. exclusion criteria: participants in pfizer phase i studies who are unable or unwilling to complete the survey instruments.

Keywords: healthy volunteers motivations decision making motivation
post-marketing surveillance (special use-results surveillance on long-term use) with sogroya®

Conditions: Adult Growth Hormone Deficiency

Summary: participants are invited to take part in this study because they have aghd (only severe case). the purpose of this study is to assess long term safety and effectiveness of sogroya® in patients with aghd (only severe case) under normal clinical practice condition in japan. participants will get sogroya® as prescribed by the study doctor. participants will be in the study for about 2 to 5 years depending on when they take part in the study. participants will be asked to fill in the quality of life questionnaires.


Eligibility criteria:
inclusion criteria: 1. signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) 2. the decision to initiate treatment with commercially available sogroya® has been made by the patient/lar and the treating physician before and independently from the decision to include the patient in this study. 3. male or female, no age limitation 4. diagnosis of aghd (only severe case) 5. gh treatment naïve ("naïve patients") or "switched patients". "naïve patients" are patients who are not exposed to any gh product to date or patients who were exposed to other gh product more than 180 days prior to registration. "switched patients" are patients who is now treated by other gh product or patients who were exposed to other gh product within 180 days prior to registration. exclusion criteria: 1. previous participation in this study. participation is defined as having given informed consent in this study 2. mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation 3. patients with hypersensitivity to the active substance or to any of the excipients 4. patients with malignant tumor 5. female patients who are either pregnant or likely to be pregnant
bleeding time study with azd6482, clopidogrel and asa

Conditions: Antiplatelet Effect

Summary: the primary purpose of this study is to evaluate the effect of azd6482 and clopidogrel on bleeding time when taken together with low-dose asa.


Eligibility criteria:
inclusion criteria: * bmi between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive * provision of written informed consent exclusion criteria: * personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms. * acute illness, surgical procedure or trauma from 2 weeks before pre-entry visit until the first baseline visit or clinically significant abnormalities in clinical chemistry, haematology, urinalysis or supine bp or pulse * known impaired glucose tolerance, known galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or known or suspected gilbert's syndrome

Keywords: antiplatelet