Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of empagliflozin (bi 10773) versus placebo and sitagliptin over 24 weeks in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of this study is to investigate the efficacy, safety and tolerability of bi 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with t2dm with insufficient glycaemic control. for the open-label part of the study the objective is to estimate the efficacy and safety of bi 10773 when given for 24 weeks in patients with t2dm with very poor glycaemic control.


Eligibility criteria:
inclusion criteria: 1. diagnosis of type 2 diabetes mellitus prior to informed consent; 2. male and female patients on diet and exercise regimen who are drug-naïve; 3. hba1c \>= 7.0% and \ 10.0% at visit 1 (screening) for the open-label bi 10773 arm; 4. age \>= 20 (japan); age \>= 18 (countries other than japan); 5. bmi \<= 45 kg/m2 at visit 1 (screening); 6. signed and dated written informed consent by date of visit 1 exclusion criteria: 1. uncontrolled hyperglycaemia; 2. acute coronary syndrome (non-stemi, stemi and unstable angina pectoris), stroke or tia within 3 months prior to informed consent; 3. indication of liver disease, either alt, ast, or alkaline phosphatase above 3 x uln; 4. impaired renal function (egfr\<50 ml/min); 5. bariatric surgery within the past two years or other gi surgeries; 6. medical history of cancer; 7. contraindications to sitagliptin; 8. blood dyscrasias or any disorders causing haemolysis or unstable red blood cell; 9. treatment with any anti-diabetes drug within 12 weeks prior to randomisation; 10. treatment with anti-obesity drugs or any other treatment leading to unstable body weight; 11. current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except t2dm; 12. pre-menopausal women who are nursing or pregnant or are of child-bearing potential and not practicing an acceptable method of birth control; 13. alcohol or drug abuse; 14. intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial; 15. any other clinical condition that would jeopardize patients safety while participating in this clinical trial
electro-acupuncture treatment in patients with osteoarthritis of the knee (eatoak)

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to assess the efficacy of electroacupuncture (ea) on pain control, perception of pain, plasma cortisol and beta-endorphins levels, patient-perceived quality of life and use of pain medications, in people with chronic knee pain.

previous randomised trials and meta-analyses have shown certain efficacy of acupuncture in some chronic painful conditions, in spite of methodological weaknesses. the hypothalamic-pituitary-adrenal (hpa) axis and the endogenous opioid (eo) system are the mechanisms appear to explain how acupuncture works in part. these systems have been shown to be important mediators of stress, pain and other stimuli. the osteoarthritis research international suggest that osteoarthritis (oa) treatment should be multidisciplinary and recommended acupuncture as one of 12 possible non-pharmacological modalities for treating oa. this study is a randomized, double-blind, placebo-controlled trial, parallel design. 128 out-patients over 50 years with oa of the knee will be recruited from mallorca, spain. participants will be randomly allocated into two groups: placebo/sham acupuncture, non insertion technique, and ea. acupuncture treatments will be used the traditional chinese medicine (tcm) style. the patients will be evaluated after a period of one month (2 sessions weekly), three months (1session monthly), six months (1 session every 45 days) and again one year later (1 session every 2 months), at the end of the study.

Eligibility criteria:
inclusion criteria: * patients of either sex with primary osteoarthritis of one or both knees fulfilling diagnostic criteria for osteoarthritis knee laid down by american college of rheumatology. * patients also had to have a kellgren-lawrence (radiologic criterion) score of at least 2 and chronic pain in the knee joint for more than 3 months. exclusion criteria: * the patients with secondary osteoarthritis of knees * associated systemic arthropathies, e.g. rheumatoid arthritis and gout * patients on steroids * disease modifying drugs, e.g. methotrexate and azathioprine * patients with recent trauma in the area of acupuncture * history of intra articular injection of steroid within last two months * patients missing two or more sessions of electro-acupuncture consecutively were excluded from the study

Keywords: acupuncture knee pain
safety study of hpp854 in subjects with mild cognitive impairment or a diagnosis of mild alzheimer's disease

Conditions: Mild Alzheimer's Disease; Mild Cognitive Impairment

Summary: this is a safety and tolerability study investigating the effect of hpp854 in subjects with mild cognitive impairment or a diagnosis of mild alzheimer's disease. the study will assess the pharmacokinetic and pharmacodynamic relationships of hpp854 in plasma, pharmacodynamic relationship in cerebral spinal fluid and plasma concentration profiles for amyloid-beta.


Eligibility criteria:
inclusion criteria: * medical history for at least 6 months prior to screening of mild cognitive impairment with a mini mental state exam (mmse) score between 20 and 26 or diagnosis of mild alzheimer's disease; * must be able to swallow dose of study medication; * body mass index (bmi) between 18.0 and 35.0; and * subject and project partner are willing to participate and agree to comply with all study requirements. exclusion criteria: * blood pressure \> 160 mmhg (systolic) and \> 90 mmhg (diastolic); * received hpp854 in a previous trial; * participation in another clinical trial involving any marketed or investigational drug within 30 days of screening and until after the final study visit. * current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia including but not limited to: anxiety, epilepsy, focal brain lesion, parkinson's disease, seizure disorder, or head injury with loss of consciousness and alcohol or substance abuse; * clinically significant cardiovascular, cerebrovascular disease, diabetic condition, hematologic, renal hepatic, pulmonary, endocrine, neurological, coagulation disorder; * history or presence of cancer except for non melanoma skin cancer. subjects with a history of prostate cancer stable for \> 3 yrs with no active treatment for \> 3 years prior to screening may be considered for eligibility; * use of the following medications/therapy from 14 days before dosing until after the final visit: anti-cholinergic, tricyclic antidepressants, lithium, typical or atypical antipsychotic medications, anticonvulsant medications, immunosuppressive agents, oral corticosteroids, and radiotherapy; * hba1c \> 6.5 % at the screening visit; * vitamin b12 level \< 211 pg/ml at the screening visit; * any suicidal risk determined by c-ssrs administered by a study staff member appropriately certified for administration of the scale (baseline/screening, phase 1 study version) at screening visit, day -6 or day -1; * a score of 15 or more on the modified geriatric depression scale (gds); and * a score of 5 or more on the hashinski ischemic scale (rosen modification. * contraindications of mri including: metallic fragments, clips or devices in the brain, eye, spinal canal, etc; cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants, etc. * contraindications for blood or csf sampling, including: bleeding disorder or taking anticoagulants/antiplatelet, chronic active infection.
dynamic ct perfusion for functional assessment of coronary artery disease

Conditions: Coronary Artery Disease

Summary: the objective of this multicenter study is to evaluate the diagnostic accuracy of dynamic cardiac ct perfusion (ctp) imaging for non-invasive functional assessment of coronary artery disease (cad). the proposed ctp technique allows concomitant assessment of two imaging-derived cardiac biomarkers including fractional flow reserve (ffr) and myocardial perfusion from a single dynamic imaging sequence, which facilities simultaneous evaluation of the hemodynamics in epicardial coronary arteries and coronary microcirculation in patients with cad. the ctp results will be compared with invasive coronary angiography / ffr assessment and non-invasive cardiac magnetic resonance imaging (cmr) / radionuclide perfusion assessment.


Eligibility criteria:
1. subject inclusion criteria patients need to meet all the following inclusion criteria to be enrolled in the study: 1. symptomatic and hemodynamically stable 2. acute coronary syndrome (acs) ruled out based on absence of abnormal changes in ecg and cardiac enzymes 3. referral for cardiac catheterization based on clinical history and non-invasive imaging test findings. non-invasive imaging findings include one or more of the following: (i) evidence of myocardial ischemia from radionuclide myocardial perfusion imaging; (ii) evidence of myocardial ischemia from cmr myocardial perfusion imaging; (iii) evidence of ≥ 50% stenosis in the left circumflex artery (lcx), left anterior descending artery (lad) and/or right coronary artery (rca) from ccta. 4. ability to undergo stress myocardial perfusion test (absence of contraindications for vasodilator) 5. written informed consent 2. subject exclusion criteria patients meeting at least one of the following criteria will be excluded from the study: 1. recent (\< 1 month) acs 2. ccta reveals ≥ 50% stenosis in the left main artery 3. severe chronic kidney disease (ckd) with estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m2 4. contraindications to stress perfusion imaging, including: i) severe reactive airway disease; ii) high-grade atrioventricular block; iii) allergy to vasodilators; iv) caffeine within 12 hours; v) theophylline use within 48 hours. 5. history of cabg surgery 6. history of malignancy during the past 3 years prior to screening 7. history of alcohol and/or drug abuse within 3 years prior to screening 8. sign of pregnancy 9. pregnant or nursing 10. history of severe allergic or anaphylactic reaction to any allergen including drugs and contrast agents 11. recent (\< 1 month) use of an investigational drug or device 12. participation in any other investigational drug or device trial during the conduct of this study 13. lack of ability or willingness to comply with the protocol requirements or deemed by the site investigator to be unfit for the study

Keywords: computed tomography myocardial perfusion fractional flow reserve
study to evaluate the safety and efficacy of pbcln-010 in combination with pbcln-014 in participants receiving allogeneic hematopoietic cell transplantation

Conditions: Hematologic Malignancy

Summary: this is a phase 2a, open-label, multicenter study to evaluate the safety and efficacy of hmo (pbcln-010) and b. infantis (pbcln-014) on the gut microbiome and gi domination by pathobionts in participants receiving allo-hct. approximately 60 participants will be enrolled in this study, and all participants will undergo screening assessments up to 28 days before the first study drug dose (d 7). participants meeting all the eligibility criteria based on the screening assessments will be enrolled and randomly assigned to 1 of the 3 cohorts: * cohort a (hmo 9.0 g and b. infantis) bid * cohort b (hmo 4.5 g and b. infantis) bid * cohort c (control cohort): participants in this cohort will not receive any study drug.


Eligibility criteria:
inclusion criteria: 1. signed informed consent prior to initiation of any study-specific procedure or treatment. 2. male and female participants 18 to 75 years of age at the time of informed consent. 3. planning to receive a first allo-hct. 4. able to comply with protocol requirements. exclusion criteria: 1. participants with prior bowel resection resulting in colostomy 2. serious medical or psychiatric illness likely to interfere with participation in study. 3. history or presence, upon clinical evaluation, of any illness that, in the opinion of the investigator, would interfere with the ability to provide informed consent or comply with study instructions. 4. female participants who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.

Keywords: allo-hct microbiome gut engraftment
efficacy of the cognitive training based on location information and activity in people with mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: the purpose of this study is to examine therapeutic efficacy of cognitive training based on location information and activity in people with mild cognitive impairment

* a single arm, open-label study. * cognitive training based on location information and activity is consists of both cognitive training and exercise(walking) using objects in the participant's home. the researchers visit the participant's home and find objects that were mainly used in the real life and easy to access (table, computer, television, etc.) and attach the recognition bluetooth low energy(ble) tag (sticker integrated). the stickers printed on the tags consist of word categories (eg animals) belonging to a particular category, so as to assist strategic recall in the stepped recall task. the participants follow the instruction from the tablet-based program to perform the task. during performing the cognitive training program, the participants are guided to walk between the tagged objects in their home. * the participants are aged over 60 years old and diagnosed with mild cognitive impairment.

Eligibility criteria:
inclusion criteria: * aged above 60 * confirmed literacy o diagnosed with mild cognitive impairment by international working group on mild cognitive impairment and clinical dementia rating(cdr) of 0 or 0.5. exclusion criteria: * evidence of delirium, confusion * any neurological conditions causing cognitive decline such as parkinson's disease, brain hemorrhage, brain tumor, normal pressure hydrocephalus * evidence of severe cerebrovascular pathology * presence of depressive symptoms that could influence cognitive function * presence of medical comorbidities that could result in any difficulties in study participation

Keywords: cognitive training cognitive intervention cognitive rehabilitation
uterine fibroid pregnancy registry

Conditions: Birth Defects; Pregnancy; Uterine Fibroids

Summary: the uterine fibroid pregnancy registry is a usa and european-based registry designed to monitor pregnancies in women with uterine fibroids in order to 1. estimate the risk ratio of birth defects in women with uterine fibroids who were treated or untreated during pregnancy and 2. detect any pattern of birth defects among pregnancies in specific treatment groups. those pregnant women exposed to various therapies used to treat uterine fibroids will be compared with those not exposed to treatment in order to detect any potential increase in the risk of major birth defects.

this is a prospective, observational, registration and follow-up study of patients with uterine fibroids who become pregnant and their offspring. those who are exposed to treatment at any time during pregnancy or within one month of conception will be compared with those not exposed to treatment. enrollment of patients into the registry may be initiated by health care providers and/or pregnant patients. health care providers provide all information related to the pregnancy and the outcome. during the study, data will be collected on uterine fibroids, exposure to treatment for uterine fibroids, potential confounding factors, and pregnancy outcome. reported cases will be reviewed and classified according to type of birth defects. registry enrollment is voluntary and should occur as early in pregnancy as possible, preferably before any prenatal testing. midway between enrollment and the expected date of delivery, the registry conducts a short interim follow-up with the health care provider to supplement registration data. near the estimated date of delivery, the registry prompts the health care provider to provide pregnancy outcome data. the data elements requested include: * health care provider contact information * eligibility criteria * uterine fibroid treatment (30 days prior to conception and during pregnancy and includes non-steroidal anti-inflammatory drugs, oral contraceptive pills, progestational agents, gonadotropin-releasing hormone (gnrh) agonists, and other oral agents) * pregnancy/birth outcome * maternal information * prenatal tests * uterine fibroid classification if a live birth is reported, the registry conducts the follow-up with the infant's health care provider within 2 months of birth, and at 12 months of age. if a birth defect is indicated, the registry will request additional targeted follow-up information from the health care provider. data on any adverse event will be forwarded to the sponsors.

Eligibility criteria:
inclusion criteria: * patient is currently pregnant or report is a retrospective defect * patient was diagnosed with uterine fibroids prior to becoming pregnant * patient is between the ages of 20 and 55

Keywords: birth defects pregnancy uterine fibroids fibroids
precision cell immunotherapy combined with tace in advanced liver cancer

Conditions: Precision Cells; Transcatheter Arterial Chemoembolization; Advanced Liver Cancer

Summary: objectives: to evaluate the safety and effectiveness of cell therapy using precision cells combined with tace in advanced liver cancer. eligibility: individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with advanced liver cancer.

a total of 40 patients may be enrolled over a period of 1-2 years.

Eligibility criteria:
inclusion criteria: * age 18\~65 years old, male or female; * life expectancy≥6 months; * ecog score: 0-3; * advanced malignancies (lung cancer, gastric cancer) were diagnosed by pathological or clinical physicians,and diagnosis of hepatocellular carcinoma (hcc), surgery can not be performed but tace treatment can be carried out; * enough venous channel, no other contraindications to the separation and collection of white blood cells; * laboratory examination: white blood cell≥3 x 10\*9/l, blood platelet count≥60 x 10\*/l, hemoglobin≥85g/l; lymphocyte count≥15%, total bilirubin≤100 mol/l; alt and ast less than five times of the normal level; serum creatinine less than 1.5 times of the normal level; * signed informed consent; * women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion. exclusion criteria: * expected overall survival \< 3 months; * the tumor size or quantity is not suitable for interventional treatment or portal vein tumor thrombus; * liver function is childs pugh c; * had received tace therapy previously or in radiotherapy at present,or taking sola feeney; * other serious diseases:the heart,lung, kidney, digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc; * unable or unwilling to provide informed consent, or fail to comply with the test requirements.

Keywords: precision cells transcatheter arterial chemoembolization advanced liver cancer
efficacy and safety of idelalisib (gs-1101) in combination with rituximab for previously treated indolent non-hodgkin lymphomas

Conditions: Indolent Non-Hodgkin's Lymphomas

Summary: the primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (pfs) in adults with previously treated indolent non-hodgkin lymphoma (inhl). an increased rate of deaths and serious adverse events (saes) among participants with front-line chronic lymphocytic leukemia (cll) and early-line inhl treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (dmc) during regular review of 3 gilead phase 3 studies. gilead reviewed the unblinded data and terminated this study in agreement with the dmc recommendation and in consultation with the us food and drug administration (fda).


Eligibility criteria:
key inclusion criteria: * histologically confirmed diagnosis of b-cell inhl, with histological subtype limited to the following: 1. follicular lymphoma (fl) grade 1, 2, or 3a 2. small lymphocytic lymphoma (sll) with absolute lymphocyte count \< 5 x 10\^9/l at the time of diagnosis 3. lymphoplasmacytoid lymphoma/waldenström macroglobulinemia (lpl/wm) 4. marginal zone lymphoma (mzl) (splenic, nodal, or extra-nodal) key exclusion criteria: * history of lymphoid malignancy other than those allowed per inclusion criteria * ongoing drug-induced liver injury, active hepatitis c, active hepatitis b , alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension. * received previous treatment with rituximab that was not effective. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: inhl indolent nhl follicular lymphoma cal-101 rituximab small lymphocytic lymphoma lymphoplasmacytoid lymphoma waldenstrom macroglobulinemia lpl wm marginal zone lymphoma mzl sll fl gs-1101 idelalisib
to compare the effects of two doses of vandetanib in patients with advanced medullary thyroid cancer

Conditions: Thyroid Cancer

Summary: the purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. it will also help the investigators understand the side effects of different doses in these patients.

an international, randomised, double-blind, two-arm study to evaluate the safety and efficacy of vandetanib 150 and 300mg/day in patients with unresectable locally advanced or metastatic medullary thyroid carcinoma with progressive or symptomatic disease

Eligibility criteria:
inclusion criteria: * written consent from female or male patients aged 18 years and over. previously confirmed histological diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic mtc objective disease progression within the previous 14 months prior to enrolment, and/or * have one or more symptoms that the investigator believes to be related to the patient's mtc. * world health organisation (who) or eastern cooperative oncology group (ecog) performance status 0-2. * has measurable disease (at least one lesion, not irradiated within 12 weeks of study randomisation, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with ct or mri). * lesions must be amenable to accurate and repeat measurement. exclusion criteria: * prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before randomization. * abnormal liver function tests (bilirubin more than 1.5xulrr, and alt, ast, or alp more than 2.5xulrr or 5.0xulrr if related to liver metastases). * significant cardiac conditions or events such as reduced cardiac functions, symptomatic cardiac arrhythmia requiring treatment, congenital long qt syndrome, history of drug-induced qt prolongation, or qtcf correction unmeasurable or more than 450 ms. * abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance. * for women only - currently pregnant or breast feeding.

Keywords: medullary thyroid cancer metastatic thyroid cancer carcinoma of the thyroid receptor tyrosine kinase inhibitor vegfr unresectable locally advanced thyroid cancer