Kornimate/medical-research-clean huggingface dataset:
singapore healthy alternative protein evaluation study

Conditions: Diabetes Mellitus; Cardiovascular Diseases; Protein Metabolism Disorder

Summary: the overall aim of this randomized controlled trial is to investigate the effects of consuming a plant-based meat alternative diet (pbmd) compared to an animal-based meat diet (abmd) on cardiometabolic health and protein homeostasis in chinese men and women in singapore. this will be achieved through the following specific objectives: (1) to evaluate the effects of dietary protein source on metabolic health and glycemic control(2) to evaluate the effects of dietary protein source on risk factors of cardiovascular diseases (3) to evaluate the effects of dietary protein source on protein homeostasis and metabolism.


Eligibility criteria:
inclusion criteria: 1. chinese males and females 2. age \> 30 to \</= 70 years 3. habitually consuming between 2 and 4 servings of protein-rich foods daily (\~20 g protein per serving) 4. raised blood glucose (fasting glucose \>/= 5.4 and \ /= 5.7 and \</= 6.4 %) 5. fully vaccinated against covid-19 (referred to as having completed a minimum of 2 doses pfizer-biontech / comirnaty / moderna or 3 doses sinovac-coronavac) 6. ability to give an informed consent 7. willing to adhere to study intervention procedures exclusion criteria: 1. obese: bmi (\>/= 27.5 kg/m2) and/or waist circumference (\>/= 102 cm for male; \>/= 88 cm for female) 2. significant weight change (± 5 % body weight) during the past 3 months 3. past bariatric surgery 4. women who are pregnant, lactating or planning pregnancy 5. history or known present diagnosis of cardiovascular (i.e.hypertension (systolic/diastolic blood pressure: \>/= 140/90 mmhg), endocrine (i.e. type 1 and type 2 diabetes mellitus), gastrointestinal, hematological (g6pd and coagulation disorders), hepatic (hepatitis b and c), malignant, renal, respiratory, thyroid or other relevant disorders which may affect the outcomes of interested in consultation with the researchers involved 6. prescribed and regularly taking western or traditional medicine which may affect the outcomes of interest in consultation with the researchers involved 7. history or present diagnosis of hiv and/or tuberculosis. 8. drug abuse within the last 5 years 9. taking dietary supplements which may affect study outcomes one month prior to their first visit (e.g. protein supplements, omega-3/6 supplements or other nutritional supplements such as ensure, anlene etc.) 10. following any special diets which may interfere with intervention procedures (for medical, aesthetic or religious reasons) 11. allergy to nuts, seeds, legumes (soy, pea), cereal (wheat gluten), beef, pork, chicken or any other ingredients present in foods provided for intervention 12. excessive alcoholic beverage consumption \> 2 servings per day (1 serving is defined as 360 ml beer, 150 ml wine or 45 ml distilled spirits) 13. smoking (cigarette, e-cigarette, cigar, pipe) or vaping 14. exercising vigorously over the past 3 months 15. staff of prince september pte. ltd. (pinduoduo inc.) and/or singapore institute of food and biotechnology innovation (sifbi)
addressing cancer-related financial toxicity in rural oncology care settings

Conditions: Neoplasms; Carcinoma

Summary: the financial burden, or financial toxicity (ft), of cancer is a consequential and growing problem, particularly for rural patients. it is important to improve our understanding of how financial navigation (fn) can reduce the material, psychological, and behavioral burden of costs associated with cancer care in both rural and non-rural community settings. the purpose of this study is to conduct a financial navigation program in 5 rural and 4 non-rural oncology practices in north carolina and evaluate the effects of financial navigation on patient outcomes, including financial toxicity and health-related quality of life.

this study is designed to evaluate the implementation and effectiveness of a financial navigation intervention within 5 rural and 4 non-rural oncology settings in north carolina. financial navigators from each of the 9 sites will recruit and enroll 255 patients total across all sites into a financial navigation program. the financial navigation intervention consists of screening patients using the cost measure for financial toxicity. if the patient scores 23 or lower, they are considered to have moderate to severe financial toxicity and will be enrolled in the study. patients will then complete a series of baseline questionnaires to measure their health related quality of life and then they will meet with a financial navigator for a comprehensive intake process to determine potential financial assistance resources the patient may be eligible for and continued visits with the financial navigator until all financial assistance resources have been explored and patients have received benefits or referrals to financial assistance programs. at the end of the intervention, the patients will complete the cost measure again, and repeat baseline surveys to measure health-related quality of life and the patient's acceptability and responsiveness of the financial navigation intervention. patient participation depends on the depth of patient need but ranges from 2 visits to 6 visits with the financial navigator over approximately 4 months but possibly longer depending on the complexity of the patient's financial need.

Eligibility criteria:
inclusion criteria: * patients 18 years of age and older * patients with any type of cancer diagnosed within 5 years and/or living with advanced disease * patients who score 22 or lower on the cost measure indicating high ft * patients must be able to read and speak english exclusion criteria: * participants without a cancer diagnosis * patients diagnosed more than 5 years ago without advanced disease * patients or caregivers under the age of 18 * patients who do not sign the consent form * patients who do not complete the baseline cost survey * patients who cannot read and speak english

Keywords: financial toxicity cancer financial navigation carcinoma neoplasms
safety, tolerability, and immunogenicity of a booster dose of zoster vaccine, live (v211-029)

Conditions: Herpes Zoster; Varicella-zoster Vaccine

Summary: this study was conducted to obtain safety and immunogenicity data after a booster dose of zoster vaccine, live administered ≥10 years following an initial dose. this information was compared to similar information obtained after zoster vaccine, live administration to age-matched and younger participants who received their first dose of zoster vaccine, live. the study was designed to determine: 1) whether a booster dose of zoster vaccine, live in participants ≥70 years of age induces an antibody response that is noninferior to that of a first dose of zoster vaccine, live in participants matched for age; 2) whether a booster dose of zoster vaccine, live induces an acceptable rise in the level of varicella-zoster virus (vzv) antibodies.

all participants were followed for one year after completion of the 42-day post-vaccination period while groups 1 and 2 were followed for a total of three years.

Eligibility criteria:
inclusion criteria: * all groups: * must not have a fever of ≥100.4° f on the day of vaccination * any underlying chronic illness must be in stable condition * history of varicella or residence in a vzv-endemic area for ≥30 years * group 1: * 70 years of age or older * took part in the shingles prevention study (sps) (v211-004, nct00007501) and received a single dose of zoster vaccine, live ≥10 years prior to enrollment in this study * group 2: * 70 years of age or older * group 3: * 60 to 69 years of age * group 4: * 50 to 59 years of age exclusion criteria: * all groups: * history of hypersensitivity reaction to any vaccine component or an anaphylactic/anaphylactoid reaction to neomycin * prior history of herpes zoster * pregnant or breast-feeding, or expecting to conceive within the duration of the study * has been treated with immunoglobulin or any blood products, other than autologous (self-donated) blood transfusion, in the 5 months prior to vaccination * received any other vaccine within 4 weeks prevaccination * on immunosuppressive therapy * has known or suspected immune dysfunction * is taking any non-topical antiviral therapy with activity against herpesviruses, including, but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir. * groups 2, 3, and 4: * has previously received any varicella or zoster vaccine

Keywords: shingles vaccine
the medtronic resolute us clinical trial

Conditions: Coronary Artery Disease

Summary: the objective of the study is to assess the safety and effectiveness of the resolute zotarolimus-eluting coronary stent system for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (rvd) of 2.25 mm to 4.2 mm.

the trial is comprised of four studies: the 2.25 mm - 3.5 mm main study (1242 patients), the 2.25 mm - 3.5 mm angio/ivus sub-study (100 patients), the 4.0 mm sub-study (60 patients), and the 38 mm length sub-study (114 patients). a patient's inclusion in a given study is dependent on the size (diameter or length) of the stent(s) the patient receives.

Eligibility criteria:
general and angiographic inclusion criteria highlights: * acceptable candidate for percutaneous coronary intervention (pci),stenting, and emergency coronary artery bypass graft surgery * clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study * informed consent * patient agrees to comply with specified follow-up evaluations at same investigational site * single target lesion or two target lesions located in separate coronary arteries * de novo lesion(s) in native coronary artery(ies) * target lesion(s) ≤ 27 mm in length (or ≤ 35 mm for a lesion to be treated with a 38 mm length stent) * target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm, (or 3.0 to 4.2 mm for it to be treated with a 38 mm length stent) general and angiographic exclusion criteria highlights: * within 7 days of implant platelet count \ 700,000 cells/mm³; wbc count \ 2.5 mg/dl * acute mi within 72 hrs of the index procedure (qwmi or any elevation of ck-mb \> lab upper limit of normal) * previous pci of target vessel(s) within 9 months prior to the procedure * planned pci of any vessel within 30 days post-index procedure and/or planned pci of target vessel(s) within 12 months post-index procedure * history of stroke or tia within prior 6 months * participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints * inability to comply with required trial antiplatelet regimen * previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent * target vessel(s) has/have other lesions w/ \> 40% diameter stenosis * unprotected left main coronary artery disease

Keywords: target vessel revascularization (tvr) myocardial infarction (mi) target vessel failure (tvf) target lesion revascularization (tlr) target lesion failure (tlf) stent thrombosis restenotic lesion percutaneous coronary intervention (pci)
effectiveness of a hospital addiction service in treating opioid and alcohol addiction

Conditions: Alcohol Addiction; Opiate Addiction

Summary: hypothesis: patients who are addicted to opioids or alcohol will have reduced substance use, health care utilization if they have immediate and convenient access to pharmacotherapy and addiction counselling. summary: this randomized trial will compare two different interventions for 124 alcohol and opioid-addicted patients admitted to either women's own detox (wod) at the university health network or the withdrawal management service (wms) at saint michael's hospital (smh. the delayed intervention group will receive a card with contact information for the st. michael's hospital and women's college hospital addiction medicine services. the rapid intervention group will be seen by an addiction physician from one of these services, within a day or two of their admission to the wod or the smh wms. the addiction physician will prescribe buprenorphine or anti-alcohol medications, and the physician, nurse and/or therapist will provide ongoing counseling, follow-up and shared care with the family physician. outcomes (measured at 6 and 12 months) include treatment retention, health care utilization and cost, medications prescribed, and alcohol and opioid use.


Eligibility criteria:
inclusion criteria: * a possible alcohol use disorder, as determined by a score of 8 or above on the audit (alcohol use disorders identification test); or, a possible opioid use disorder, as determined by positive responses on the eligibility form: within the past 30 days, opioid use has been a problem, and at least one harmful consequence of opioid use has been present, eg withdrawal symptoms, or problems with family, friends, work, money etc. if the addiction physician who assesses the patient at the first visit to the addiction service concludes that these screening tests were falsely positive and the patient does not have an alcohol or opioid use disorder, the physician will contact the ra to discharge the patient from the study. * interested in receiving treatment at an addiction medicine service. * is alert and able to provide informed consent (ie is not confused, agitated, hostile, intoxicated, sedated or in severe withdrawal) * has attended a hospital emergency department or has been admitted to hospital in ontario within the past year. * can speak and read english. exclusion criteria: * pregnant * currently receiving methadone or buprenorphine treatment * cognitively impaired * unable to speak or read english
metadoxine as a therapy for severe alcoholic hepatitis

Conditions: Severe Alcoholic Hepatitis

Summary: the purpose of this study is to determine whether metadoxine is effective for improve survival and reduced oxidative stress in patients with severe alcoholic hepatitis.


Eligibility criteria:
inclusion criteria: * patients with clinical and biochemical criteria for severe alcoholic hepatitis: total bilirubin greater than 5 mg/dl in absence of biliary tract obstruction evidenced by ultrasound, history of chronic alcohol intake, leukocytosis, neutrophilia, elevation of transaminases with an aspartate aminotransferase / alanine aminotransferase ratio equal or greater than 2, discriminant function greater than 32. exclusion criteria: * diabetes, chronic kidney disease, hepatitis c, hepatitis b and or human immunodeficiency virus infection, asthma or history of atopy or allergic reactions, therapy in the previous two years with steroids, pentoxifylline, metadoxine, s-adenosyl l- methionine, antioxidants or multivitamins.

Keywords: severe alcoholic hepatitis survival oxidative stress
a study to assess the safety, tolerability and efficacy of ertapenem sodium in the treatment of complicated urinary tract infections (0826-048)

Conditions: Urinary Tract Infection

Summary: the purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.


Eligibility criteria:
inclusion criteria: * patient has a complicated urinary tract infection * patient has acute pyelonephritis with fever, flank pain, pus in the urine, and positive urine culture * patient is indian and 18 years of age or greater. exclusion criteria: * patient had a kidney transplant * patient had been given antibiotic therapy for condition * patient had poor liver function * patient has complete obstruction of urinary tract * patient has history of serious allergy to antibiotics and multivitamins * patient is pregnant * patient not likely to respond to 10 to 14 days of antibiotic therapy * patient not likely to survive 4 week study period
effects of hia and pce in primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: the main purpose of study is to manage the unpleasant pain suffered by females during mensturation. the aim of this study is to guide physiotherapist that how to apply these exercises to manage dysmenorrhea.

there are less research on effectiveness of pelvic clock exercises in dysmenorrhea they are very less evidence and less documented in literature.. although there are many researches on high intensity aerobics.previous researches only have lierature about aerobics.so to address this literature gap, conduct a prospective randomized controlled trial to investigate the effects of high intensity aerobics and pelvic clock exercises in primary dysmenorrhea.

Eligibility criteria:
inclusion criteria: * girls aged 17-23 years with regular menstrual cycle * unmarried girls exclusion criteria: * athletes, married women, * girls who were regularly exercising * having any pelvic pathology, abnormal menstrual cycle.

Keywords: high intensity aerobics primary dysmenorrhea aerobics painful menstruation
aspergillus and chronic obstructive pulmonary disease evolution

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this is a prospective multicenter cohort study which includes all consecutive copd patients who come for a visit in one the participating pneumologist. they will have to do a sputum and to complete some questionnaries. questionnaries will be redone by phone after 1 and 3 months and during the visit after 6 months. we will correlate aspergillus presence in sputum with quality of life (qol), and copd symptoms evaluated by questionnaires.

aspergillosis disease is a growing problem. these diseases are not yet uncommon in chronic obstructive pulmonary disease patients. (copd). aspergillosis disease are very difficult to be diagnosed or treated. isolation of aspergillus in sputum of patients is not always responsible of a real disease. need of treatment is discussed. that is why, we will conduct a prospective cohort study to evaluate aspergillus rate in respiratory samples of copd patients (gold stage iii or iv)

Eligibility criteria:
inclusion criteria: * copd patients gold stage iii and iv exclusion criteria: * cystic fibrosis * pulmonary fibrosis * hematological malignancy * known aspergilloma * allergic bronchopulmonary aspergillosis
efficacy and safety of s-amlodipine 2,5 mg and 5 mg in hypertension patients

Conditions: Hypertension

Summary: s-amlodipine besylate 2,5 mg tablet will be administered to patients have not received any hypertension treatment before or have received any of anti-hypertensive mono-therapy for the first four weeks of treatment. by increasing dose, s-amlodipine besylate 5 mg tablet will be administered for the last four weeks (4-8 weeks).


Eligibility criteria:
inclusion criteria: * male or female outpatients 18 years and older. * hypertension patients have not received any anti-hypertensive treatment before ( ≥ 140 mmhg mssbp \< 160 mmhg, ≥ 90 mmhg msdbp \< 100mmhg). * hypertension patients controlled with single medicine. * patients giving written informed consent without being under any influence. exclusion criteria: * pregnant patients, nursing mothers or female patients who have potential for childbearing and do not use any effective contraceptive method. * allergy or hypersensitivity to dihydropyridines. * patients receive more than one anti-hypertensive medicine. * patients with seconder hypertension. * patients with severe hypertension, myocardial infarction, nyha stage 2-4 cardiac insufficiency, history of cerebrovascular disease, past ischemic attack, encephalopathy, underwent coronary artery bypass surgery or percutaneous coronary intervention, second or third degree heart block or symptomatic arrhythmia without pacemaker, clinically significant heart valve disease, potential life-threatening or symptomatic arrhythmia, simultaneous unstable angina pectoris, type i diabetes mellitus, atrial fibrillation until the last 12 months. * uncontrolled type ii diabetes mellitus. * patients with significant liver disease (alt, ast must be \> 2xuln in beginning, patients with esophageal varices, portacaval shunt). * patients with significant kidney disease (gfr \<60 ml/min according to cockcroft-gault formula). * patients with volume depletion. * patients with pancreas disease. * patients with gastrointestinal disease which may effect absorption. * drug/narcotic and alcohol abuse until the last 12 months. * patients with central nervous system disease and taking medicine for this reason. * history of incompatibility with medical regimes or patients do not want to adhere the study protocol. * persons directly involved in the management of this protocol.
evaluation of measurable residual disease in patients with acute myeloid leukemia as surrogate endpoint for survival

Conditions: Leukemia, Myeloid, Acute

Summary: objectives to demonstrate that measurable residual disease assessed by multiparameter flow cytometry during intensive treatment is a surrogate for overall survival and thus an early read-out for drug efficacy study design surrogate endpoint trial to establish that measurable residual disease assessed by multiparameter flow cytometry during intensive treatment is a surrogate for overall survival

acute myeloid leukemia is a genetically and phenotypically heterogeneous disorder with an incidence of 3 to 4 per 100 000 men and women per year and a median age at diagnosis of about 70 years. prognosis, especially in older patients, has remained very poor. in patients considered suitable for intensive chemotherapy, the combination of an anthracycline and cytarabine remains the standard of care. for patients achieving a complete remission (cr), postremission therapy (prt) ranging from chemotherapy to allogeneic hematopoietic stem cell transplantation is required; intensive prt is still under debate in older patients. beyond pre-treatment genetics-based risk stratification, measurable residual disease (mrd) during treatment and follow up emerges as an important prognostic factor in first cr. furthermore, mrd may provide a tool for a read-out of therapeutic efficacy. in this diagnostic meta-study the investigators intend to measure mrd using multiparameter flow cytometry across up-front randomized clinical trials which in total will accrue more than 1000 patients. according to the leukemia-associated phenotype at diagnosis or the different-from-normal approach, mrd will be assessed early (after induction) and late (after consolidation) during treatment. the aim of the study is to show that levels of mrd measured early during treatment are closely related to overall survival and thus may serve as an early surrogate. there is a growing public demand that new, promising drugs are approved for therapy as rapidly as possible. therefore, it is of great interest to obtain these approvals based on early biomarker endpoints such as mrd rather than on long-term survival endpoints.

Eligibility criteria:
inclusion criteria: * acute myeloid leukemia according to the who classification * informed consent in place for a randomized study of the study alliance leukemia (sal) including the heidelberg leukemia network (helene) covering assessment of mrd by mpfc in the reference laboratories in heidelberg and dresden. exclusion criteria: * no signed informed consent compliant with the requirements of perdam

Keywords: leukemia, myeloid, acute measurable residual disease surrogate endpoint multiparameter flow cytometry