Kornimate/medical-research-clean huggingface dataset:
effect of acetylcholinesterase inhibitors on bone metabolism

Conditions: Osteoporosis

Summary: people with alzheimer's disease are at an increased risk of bone fracture. some studies have shown that those taking donepezil have a lower rate of bone fractures, but the reasons for this are unknown. the purpose of this study is to measure the effect of donepezil treatment on bone metabolism factors including bone mineral density, bone turnover markers, and bone quality. participants in this study will have a bone density test and have blood samples collected at the baseline study visit. participants will then be randomly assigned to donepezil or matching placebo to be taken daily by mouth for 12 months. blood samples will be collected at 6 and 12 months. a repeat bone density test will be performed at 12 months. participants will also complete questionnaires at each study visit.


Eligibility criteria:
inclusion criteria: 1. diagnosis of adrd, including clinical assessment and either radiographic or laboratory biomarker assessment 2. meets nia-aa clinical dementia criteria 3. willing to initiate treatment with achei for adrd 4. moca score \< 24 5. for females, either age \> 55 years, or age \< 55 years and at least 12 months since last menstrual period 6. for males, age \> 50 years 7. geriatric depression scale score \< 6 exclusion criteria: 1. currently on acetylcholinesterase inhibitor 2. currently on osteoporosis medication (e.g., bisphosphonate, serm, denosumab, teripar-atide, abaloparatide, romozosumab) 3. use of bisphosphonate within last 2 years 4. use within last 6 months of estrogens or testosterone, androgen deprivation therapy or aromatase inhibitors, antiepileptic, heparin therapy, thiazolidinediones 5. history of disorders associated with osteoporosis: collagen vascular diseases, malab-sorption, inflammatory bowel disease, severe liver disease/cirrhosis, hyperthyroidism (endogenous or exogenous) 6. history of hip fracture, hip replacement, or non-ambulatory 7. long-term use (\>6 months) of corticosteroids 8. history of parkinson's, hiv, huntington's disease 9. history of solid organ transplantation 10. severe kidney impairment (egfr \< 30 ml/sec), 11. active malignancy, except non-melanomatous skin cancer 12. 1-year mortality \> 25%, measured by eprognosis calculator 13. initiation of investigational or fda-approved anti-amyloid drug
a prognostic model for drug-induced liver injury in china

Conditions: Drug-induced Liver Injury

Summary: a prospective, multi-center, non-interventional cohort study is going to conduct to explore the clinical characteristics, culprit drug(s) or herb(s), outcomes and risk factors of drug-induced liver injury (dili) in china and screen novel serum markers. a prognostic model incorporating with the novel serum marker(s) for dili would be established and validated to imporve the prognosis of patients in china .

research objectives: 1. to establish a standardized multi-center, prospective dili cohort nationwide and obtain long-term prognostic data. 2. to establish and verify prognostic model(s) of dili in china. 3. to explore novel serum biomarkers for the prognosis of dili.

Eligibility criteria:
inclusion criteria: 1. rucam ≥6 and met one of the following biochemical conditions: (1) alt≥5 uln, (2) or alp ≥2 uln, (3) or alt≥3 uln and tbil≥2 uln. 2. rucam between 3-5, five experienced hepatologists in leading site evaluate and vote the diagnosis of dili, the case would be enrolled if only ≥4 out of 5 hepatologists agree with the diagnosis. 3. onset to enrollment ≤3 months. exclusion criteria: 1. hepatotropic viral infection: hepatitis a, b, c, d and e. 2. non-hepatotropic viral infection: cytomegalovirus (cmv) and epstein-barr virus (ebv), etc. 3. hypoxic ischemic hepatitis and congestive liver disease. 4. alcohol consumption: male \>40g/d, female \>20g/d, and ≥5 years. 5. biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis. 6. autoimmune hepatitis: international autoimmune hepatitis group (iahg) simplified score ≥6 or complicated score ≥10, or differentiation from autoimmune hepatitis is impossible during enrollment. 7. parasitic infection. 8. sepsis. 9. previous liver transplantation or bone marrow transplantation. 10. pregnancy or lactation. 11. genetic and metabolic liver diseases.

Keywords: prognostic model(s) biomarker(s) endpoint event(s)
efficacy and safety of treatment with a single dose of 90y-ibritumomab tiuxetan in patients with low tumor burden untreated or indolent nhl

Conditions: Lymphoma

Summary: the purpose of this study is to see how well zevalin works in the treatment of low grade indolent b-cell lymphoma when given to patients who have not had any previous treatment for their lymphoma and who otherwise would be followed on a "watch \& wait" policy.


Eligibility criteria:
inclusion criteria: * histologically confirmed indolent lymphoma including: * follicular grade 1 or 2 * small lymphocytic * marginal zone (nodal) * marginal zone (splenic) * mucosa associated lymphoid tissue (malt) * no evidence of transformation * stage iii or iv disease * no prior therapy * involvement by less than 25% of bone marrow on assessment of trephine biopsy * absolute lymphocyte count ≤ x 109/l * platelets ≥ 150 x 109/l * hemoglobin ≥ 100g/l * absolute neutrophil count ≥ 1.5 x 109/l * at least one bidimensionally measurable lesion at least 2cm by ct scanning exclusion criteria: * any other anticancer treatment for nhl * prior radiation therapy * prior myeloablative therapy (bone marrow or peripheral blood stem cell transplant) * no other malignancy within the past 10 years except adequately treated non-melanoma skin tumors or carcinoma in situ of the cervix * presence of central nervous system lymphoma * patients known to be hiv positive * patients with known seropositivity for hepatitis c virus, hepatitis b virus or other active infection uncontrolled by treatment * patients with abnormal liver function: total bilirubin \> 1.5x uln or alt \> 2.5x uln * patients with abnormal renal function: serum creatinine \> 2.5x uln * known hypersensitivity to murine antibodies or proteins * immunotherapy during the preceding 6 months (including monoclonal antibodies, interleukins, interferon)
prospective study on a novel port-site closure device (ez close): effectiveness and comparison with carter-thomason

Conditions: Surgical Port Site Hernia

Summary: this study aims to evaluate the efficacy and safety of a novel port-site closure device (ez close) by comparing it with the carter-thomason device.

port-site closure is a critical procedure after every laparoscopic surgery. complications such as visceral organ injury, port-site hernia, infection, ascitic fluid leakage may occur during and after the procedure. many devices were developed and utilized for the procedure and carter-thomason is one of the most commonly used device and validated with several studies. this study aims to evaluate the efficacy and safety of a novel port-site closure device (ez close) by comparing it with the carter-thomason device.

Eligibility criteria:
inclusion criteria: * all patients with laparoscopic ports over 10mm exclusion criteria: * patients with laparoscopic ports under 10mm * patients who refused the study * patients who received concurrent surgery for other reason
the effect of time intervals for rescue treatment on eradication effect of helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

Summary: the researchers collect patients who accepted eradication program of the helicobacter pylori but failed to eradicate helicobacter pylor from the outpatient clinic. after rescue therapy, evaluating the effect of retreatment interval on eradication effect of helicobacter pylori infection.

the researchers collect patients who accepted eradication program of the helicobacter pylori but failed to eradicate helicobacter pylor from the outpatient clinic. record the interval between the last eradication therapy and this time，6-8 weeks after treatment, the subjects will re-take the 13c-urea breath test. calculating the eradication rates, adverse reaction rates, patient compliance of each group. evaluating the effect of retreatment interval on eradication effect of helicobacter pylori infection.

Eligibility criteria:
inclusion criteria: * patients aged 18-70. patients with h.pylori infection (positive for any of the following: 13c/14c-urea breath test, histopathology test, rapid urease test, stool h.pylori antigen test). patients who have previously received helicobacter pylori eradication therapy and failed. exclusion criteria: * patients with serious underlying diseases, such as liver insufficiency (aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (cr≥2.0mg/dl or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, coronary heart disease or coronary artery stenosis ≥75%. patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial. patients with active gastrointestinal bleeding. patients with a history of upper gastrointestinal surgery. patients allergic to treatment drugs. patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse patients who are unwilling or incapable to provide informed consents.
human aging and in vivo noradrenergic system

Conditions: Parkinson Disease

Summary: the main goal of this research proposal is to provide, for the first time in humans, a wider understanding of the role of the noradrenergic system both in health and illness (parkinson's disease) through the use of a newly developed radiotracer (11carbon \[11c\]yohimbine) visualizing alpha-2 (α2) adrenergic receptors (ar) combined with cutting-edge technology, the hybrid positron emission tomography (pet)/magnetic resonance imaging (mri) scanner. the secondary aim of this study will be to determine whether the expected age- and parkinson's disease (pd)-related changes in the noradrenergic system are paralleled by changes in neuropsychological performances (such as cognitive, motor and/or olfactory abilities).


Eligibility criteria:
inclusion criteria for the healthy controls: * age between 20 years and 80 years * weight between 40 kilograms (kg) and 95kg * without neurologic or psychiatric history * without head trauma history including loss of consciousness superior to 30 minutes. * affiliated to a social security or similar scheme * not subject to any legal protection measures * participant must have signed an informed consent document indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study and comply with the study procedures and restrictions inclusion criteria for the patients with parkinson's disease: * age between 40 and 80 years old * weight between 40 kilograms (kg) and 95kg * with an idiopathic parkinson's disease (dopa-sensitive) * without head trauma history including loss of consciousness superior to 30 minutes. * affiliated to a social security or similar scheme * not subject to any legal protection measures * participant must have signed an informed consent document indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study and comply with the study procedures and restrictions exclusion criteria: * subject with alcohol or substance abuse history * subject with somatic drug therapies * magnetic resonance imaging (mri) contraindications (implanted or embedded metal objects in the head or body) * positron emission tomography (pet) contraindications * exposed to 1 millisievert or more of ionizing radiation in the year before the start of this study * subject unable to sign written consent for participation in the study

Keywords: human aging behavior noradrenergic system positron emission tomography magnetic resonance imaging
human versus analogue insulin for youth with type 1 diabetes in low-resource settings

Conditions: Diabetes Mellitus, Type 1; Type 1 Diabetes

Summary: the primary objective of this trial is to determine whether insulin glargine reduces the risk of serious hypoglycemia or improves time in range at 6 months when compared against standard of care human insulin (e.g. nph or premixed 70/30) among youth living with type 1 diabetes (t1d) in low resource settings.

long-acting insulin analogues have become a de-facto standard of care for patients with t1d living in high-income countries. unfortunately, insulin analogues remain unavailable or unaffordable for much of the global population. in both 2017 and 2019, applications to add long-acting insulin analogues to the who's model list of essential medicines (eml) were rejected due to insufficient evidence of superiority and an unfavorable cost-effectiveness profile when compared against older, less expensive, human insulins (e.g., nph insulin and premixed 70/30 insulin). in 2021, long-acting insulin analogues were added to the eml but the decision remains controversial since the who concluded that "magnitude of clinical benefit of long-acting insulin analogues over human insulin for most clinical outcomes was small." moreover, studies that compare long-acting insulin analogues versus human insulins conducted in high-income settings may not generalize to children and young adults living with t1d in very low-resource settings. to address this unmet need, pitt has partnered with brigham and women's hospital, the london school of hygiene and tropical medicine, the clinton health access initiative and life for a child to conduct a randomized controlled trial comparing insulin glargine, a long-acting analogue insulin, against intermediate human insulin among 400 children and young adults living with t1d in a lower resource setting.

Eligibility criteria:
inclusion criteria: 1. children and young adults (age 7-25) 2. have a clinical diagnosis of type 1 diabetes (t1d) exclusion criteria: 1. prior use of any insulin analogue 2. patients (or parents for children \<18 years old) who refuse to or cannot provide informed consent 3. who are currently pregnant or plan to become pregnant over the next year 4. who have previously used a continuous glucose monitor (cgm) for glucose monitoring 5. who were first diagnosed with t1d less than 12 months ago 6. who is diagnosed with severe malnutrition

Keywords: type 1 diabetes insulin glargine human insulin insulin analogue bangladesh tanzania
a 3-arm proof of concept study of ain457, acz885 or corticosteroids in patients with polymyalgia rheumatica

Conditions: Polymyalgia Rheumatica; Inflammatory Diseases

Summary: the study is a two-week, single-blinded, double-dummy, randomized, active-controlled, parallel group design, with a follow-up period up to a total study duration of 6-month, non-randomized, open-label phase to monitor safety, tolerability and, in responders, flare. it is a multicentric, multinational study. the protocol will seek to enroll a total of 30 patients, who will be randomized to the 3 arms at a ratio of 1:1:1. patients will have a maximum screening period of 7 days with randomization at d1 for a dosing period of 15 days followed by a follow up-period of 154 days, or 4 months (112 days) after their last biologic dose, whichever is greater, and followed by unblinded re-dosing in the case of a disease flare.


Eligibility criteria:
inclusion criteria: * patients must meet all of the following features: * patients ≥ 50 and ≤ 85 years * c-reactive protein (crp) \> 1.0 mg/dl or erythrocyte sedimentation rate (esr) \> 30 mm/hr * new bilateral shoulder and/or hip pain * early morning stiffness ≥ 60 min * duration of illness \> 1 week * a negative 5 u purified protein derivative skin test (ppd) skin test (≤ 5 mm induration) at screening exclusion criteria: * active infection or current use of antibiotics * known human immunodeficiency virus (hiv), hepatitis c virus (hcv) or hepatits b virus (hbv) * previous therapy with methotrexate or other immunosuppressive agents within three months prior to baseline * history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix within five years prior to study entry * presence of rheumatoid arthritis or other inflammatory arthritic processes (features of giant cell artertitis (gca), spondyloarthropathies), connective tissue disease, drug-induced myopathies, endocrine disorders, neurological disorders, chronic pain syndromes, as assessed by base line screening including thyroid-stimulating hormone (tsh), creatine kinase (ck), rheumatoid factor (rf), cyclic citrullinated peptide (ccp), antinuclear antibodies (ana), serum protein electrophoresis, urinalysis. other protocol-defined inclusion/exclusion criteria apply

Keywords: polymyalgia rheumatica inflammatory disease rheumatic disease
home-based heat therapy for type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Heat Exposure

Summary: insulin resistance and hyperglycemia predispose individuals with type 2 diabetes mellitus (t2dm) to endothelial dysfunction and a greater risk of cardiovascular diseases (cvd). increased cvd risk in individuals with t2dm persists despite optimal pharmacological therapy, highlighting the need to identify complementary lifestyle interventions that improve cardiometabolic functions in this population. evidence from animal models suggests that heat exposure improves metabolic functions. notably, weekly heat exposure for 16 weeks blunts hyperinsulinemia and hyperglycemia induced by a high fat diet in mice. in parallel, studies in humans have shown that heat exposure improves vascular endothelial function. based on such findings, it has been suggested that heat therapy may represent an effective lifestyle intervention to improve cardiometabolic functions. however, only 1 study has examined the impact of a heat therapy intervention on individuals with t2dm, demonstrating that 6 weeks of heat exposure reduces fasting plasma glucose and hemoglobin a1c. no study has considered potential vascular benefits of heat therapy in individuals with t2dm. this project will investigate cardiometabolic responses to repeated heat exposure in men and women with t2dm. we will test the hypothesis that 12 weeks of heat therapy improves postprandial fatty acid handling, insulin sensitivity and endothelial function in individuals with t2dm.


Eligibility criteria:
inclusion criteria: * age 45-75 years * diagnosis of type 2 diabetes mellitus ≥1 year * stable medication ≥12 weeks exclusion criteria: * class 3 obesity * hypertension not controled by medication * diagnosis of cardiac, renal and/or pulmonary disease * diagnosis of severe neuropathy and/or retinopathy * insulin therapy * fasting plasma triglycerides \>5.0 mmol/l * fasting total cholesterol \>7 mmol/l
advance directives and end-of-life decision making in intensive care medicine in germany

Conditions: Death

Summary: description of the decision making process as well as the practices of end of life care in an icu of a german university hospital during the period when changes of german legislation occurred.

most patients on the intensive care unit (icu) die after an end-of-life decision (eold) has been made (sprung et al. 2003). on september 1st 2009 the "advance-directives-law" was inured in germany considering a written advance directive of an adult binding for physicians and the patient´s surrogate decision makers if it fits into the medical context (bgbl 2009). there is a lack of data describing the process and the factors associated with end-of-life-decisions in icus in germany in detail. the purpose of this observational study is to describe the decision making process as well as the practices of end of life care in an icu of a german university hospital during a period when changes of german legislation occurred.

Eligibility criteria:
inclusion criteria: * all patients admitted to the icu * all patients discharged death from the icu exclusion criteria: * all patients discharged alive from the icu

Keywords: end-of-life decisions, critical care, advance directive
open label safety & pharmacodynamic study 24wk w/dio-902 combo w/metformin & atorvastatin in t2dm patients

Conditions: Type 2 Diabetes

Summary: diobex inc. is developing an experimental drug (dio-902) that is made up of part of the ketoconazole molecule for the treatment of elevated blood glucose associated with type 2 diabetes mellitus. ketoconazole (nizoral®) is a drug available by prescription for the treatment of fungal infections however dio-902 is an investigational drug. dio-902 may lower blood glucose by lowering levels of a naturally occurring hormone called cortisol. elevated cortisol may contribute to the development of type 2 diabetes.

to maintain the blind in protocol dio-502, subjects will be re-randomized at study visit 1 to one of three doses of dio-902: 150, 300 or 450 mg qhs. all subjects receiving dio-902 placebo and 50% of subjects receiving dio-902 will be re-randomized to one of three dio-902 doses. the remaining 50% of subjects receiving dio-902 will be assigned to their original dio-902 dose. the re- randomization will be performed by a group independent of study conduct to ensure the treatment status of the subject while in protocol dio-502 remains blinded. in addition, subjects will continue on the same dose of metformin that they had been taking during the conduct of protocol dio-502. subjects will continue on atorvastatin 10 mg for the first 4 weeks of this protocol. thereafter, at study visits 3 and 4, the dose of atorvastatin may be increased up to a maximum of 40 mg daily in order to achieve ldl-cholesterol/non-hdl cholesterol goals specified within the protocol. in addition, after study visit 4 (week 12) subjects with hba1c levels of \> 7.5% (0.075 hb fract.) will undergo a one time titration of their oral hypoglycemic regimen as per the algorithm provided in the protocol.

Eligibility criteria:
inclusion criteria: * participated in dio-502 exclusion criteria: * did not participate in dio-502

Keywords: diabetes type 2 diabetes cholesterol
association of breast reconstruction method with long-term risk of psychiatric disorders

Conditions: Breast Cancer

Summary: female breast cancer patients who underwent total mastectomy followed by breast reconstruction

female breast cancer patients who underwent total mastectomy followed by breast reconstruction

Eligibility criteria:
inclusion criteria: * the study included newly diagnosed female breast cancer patients who underwent total mastectomy exclusion criteria: * individuals who underwent reconstruction prior to mastectomy * those diagnosed with psychiatric disorders within one year prior to surgery

Keywords: autologous reconstruction implant-based reconstruction psychiatric disorders