Kornimate/medical-research-clean huggingface dataset:
a study of ly3002813 in participants with memory damage due to alzheimer's disease (ad) or ad

Conditions: Alzheimer Disease

Summary: the study will evaluate the effect of ly3002813 on brain scans. the study will evaluate the safety of ly3002813 by looking at adverse events (side effects). the study will also look at the effect the body has on ly3002813. study participants will have mild cognitive impairment (mci) due to ad or mild to moderate ad. the study involves 3 parts. * part a in which participants will receive a single dose of ly3002813 or placebo (no drug). * part b in which participants will receive multiple doses of ly3002813 or placebo for 24 weeks. * part c in which participants will receive multiple doses of ly3002813 or placebo for up to 72 weeks. drug will be given as an intravenous infusion (injection into a vein). for parts a, b and c, the study will last approximately 72 weeks, not including screening of approximately 56 days. the study is for research purposes only and is not intended to treat any medical condition.


Eligibility criteria:
inclusion criteria: * present with mild cognitive impairment (mci) due to alzheimer's disease (ad) or mild-to-moderate ad * men or nonfertile women, at least 50 years of age. nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year * have up to 2 partners who will provide a separate written informed consent to participate * have adequate vision and hearing for neuropsychological testing in the opinion of the investigator * positive florbetapir scan exclusion criteria: * do not have up to 2 reliable partners who are in frequent contact with the participant, who will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications * are being monitored for radiation due to occupational exposure to ionized radiation, or exposure to ionizing radiation within last 12 months from an investigational study * history of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy * have any contraindications for magnetic resonance imaging (mri) studies, including claustrophobia, the presence of contraindicated metal (ferromagnetic) implants, cardiac pacemaker * have allergies to humanized monoclonal antibodies, including proteins and diphenhydramine, epinephrine, and methylprednisolone * have gamma globulin therapy within the last year * previously dosed in any other study investigating active immunization against amyloid beta (aβ) * previously dosed in any other study investigating passive immunization against aβ within the last 6 months * have current serious or unstable illnesses
virtual physical rehabilitation for patients living with long covid

Conditions: COVID-19; Post COVID-19; Long COVID

Summary: the purpose of this study is to investigate whether a timely, virtual home-based physical rehabilitation program for patients living with long covid can improve functional mobility compared to usual care.


Eligibility criteria:
inclusion criteria: (i) adult patients (18+ years old) who have had a confirmed or probable covid-19 infection and who have self-reported persisting symptoms of either reduced mobility, muscle weakness, dyspnea, or fatigue; (ii) participants must be technologically capable of connecting (either independently or through household members) with an online videoconferencing platform through an e-mail invitation; and (iii) be able to collaborate with the research assistant to complete the virtual assessment sessions or have a family member available to help. exclusion criteria: (i) pre-existing or newly identified severe cognitive impairment; (ii) inability to speak or comprehend english or french; (iii) known or self-reported acute and/or uncontrolled cardiac, musculoskeletal, or neurological condition that might render rehabilitation participation unsafe.
a prospective study on diabetes management through an integrated delivery system

Conditions: Diabetes Mellitus

Summary: 1. to demonstrate a feasible hospital-based diabetic shared care model in taiwan. 2. to compare effectiveness of diabetes control between patients receiving case management provided by a health manager and patients receiving usual care. 3. to determine the optimal level of glucose, blood pressure and lipids in control of diabetes in taiwan.

five general hospitals, including both public and private, are chosen as regional coordinating centers in this project. collaborating with community physicians, project coordinating-centers randomize diabetic patients, who have signed informed consent, into either intervention or control group. while two annual comprehensive lab tests are offered to the control group, an additional package of consultations and coordinating services provided by health managers is appended to the intervention group. qualified health managers are cultivated in five selected medical institutes to support primary care physicians in managing diabetic patients. responsibilities of health managers include tracking and updating enrolled patients' information, providing adequate and scheduled consultations, arranging specialty referrals for patients in needs, and transferring stable patients back to their original physicians. the feasibility phase of the project implementation will last for three years and it will be followed by a phase of full-scale implementation for another two years. glycemic control as well as health status of participants will be the indicators to evaluate outcome of the project. at the same time, the periodic measurements on glucose, blood pressures, lipids and the incidence of complications will also be analyzed to set up an optimal target for diabetic control in taiwan.

Eligibility criteria:
inclusion criteria: 1. symptoms of diabetes plus casual plasma glucose concentration 200 mg/dl (11.1 mmol/l). casual is defined as any time of day without regard to time since last meal. the classic symptoms of diabetes include polyuria, polydipsia, and unexplained weight loss. 2. fasting plasma glucose 126 mg/dl (7.0 mmol/l). fasting is defined as no caloric intake for at least 8 hours. 3.2-hour plasma glucose 200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test (ogtt). the test should be performed using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water. exclusion criteria: 1. type 1 diabetes (insulin dependent diabetes, iddm) 2. women who are pregnant at the entry time. 3. those who have history of myocardial infraction (mi), cerebrovascular accident (cva), foot amputation and uremia under dialysis.

Keywords: diabetic shared care health manager prospective study health care quality, access, and evaluation
ces1 crossover trial of clopidogrel and ticagrelor

Conditions: Myocardial Infarction; Thrombosis; Platelet Dysfunction

Summary: the purpose of this investigation is to evaluate when genetic variation in the carboxylesterase 1 (ces1) gene influences antiplatelet therapy response, as assessed by ex vivo platelet aggregometry, in healthy participants treated with clopidogrel and ticagrelor. we hypothesize that genetic variation in ces1 will significantly impact on-clopidogrel platelet aggregation while having a minimal effect in ticagrelor-treated subjects. specific aim: to conduct a prospective randomized crossover study of clopidogrel and ticagrelor in healthy individuals stratified by ces1 genotype. participants will be recruited by ces1 genotype into a randomized crossover study of clopidogrel (75 mg daily for 7d) and ticagrelor (90 mg twice daily for 7d) with extensive phenotyping including ex vivo platelet aggregometry performed pre- and post-drug administration in order to assess the interaction of genotype and drug choice on on-treatment platelet function.


Eligibility criteria:
inclusion criteria: * of amish descent * age 18 to 75 years * participant in the phamacogenomics of anti-platelet intervention (papi-1) study or other amish research center study, or a family member of an amish research center study participant. exclusion criteria: * clopidogrel or ticagrelor allergy * platelet count \ 500,000 mm3 * hematocrit (hct) \ 50% * blood pressure \> 160/95 mm hg * co-existing malignancy * creatinine \> 2.0 mg/dl * aspartate transaminase (ast) or alanine transaminase (alt) \> 2 times the upper limit of normal * thyroid-stimulating hormone (tsh) \ 5.50 mu/l * pregnant or breast feeding * history of gastrointestinal bleeding, a major life-threatening bleeding event, active pathological bleeding, bleeding diathesis, or coagulopathy * history of stroke or transient ischemic attack, deep vein thrombosis, or atrial fibrillation * history of myocardial infarction, coronary artery bypass surgery, unstable angina, or angioplasty * history of sick sinus syndrome, 2nd or 3rd degree atrioventricular block, or bradycardia-related syncope * type 1 or type 2 diabetes mellitus * surgery in the past 3 months or planned surgery in the next 3 months * participant cannot willingly and safely discontinue medications that, in the opinion of the study physician would affect the outcomes to be measured for at least 1 week prior to study initiation through completion of the study * participant is unwilling to discontinue taking vitamins and/or supplements that, in the opinion of the study physician would affect the outcomes to be measured for 1 week prior to the study initiation through the the completion of the study * any other condition that would place prospective participants at unacceptable risk or render them unable to meet the requirements of the protocol in the opinion of the site investigator

Keywords: pharmacogenetics carboxylesterase 1 (ces1) antiplatelet therapy
pharmacokinetics of metformin intolerance

Conditions: Diabetes Mellitus, Type 2; Metformin Adverse Reaction

Summary: pharmacokinetic study of metformin intolerance

this pharmacokinetic study recruited white european individuals with type 2 diabetes, who had previously been exposed to metformin and met the criteria for tolerance or intolerance. intolerance was defined as previous exposure to metformin (maximum of 1000mg once daily for up to 8 weeks) but discontinued treatment with patient reported or documentation of gastrointestinal upset, leading to discontinuation (criterion 1). alternatively, intolerance was defined as inability to increase metformin dose above 500mg without experiencing gastrointestinal side-effects, despite having an hba1c \>53mmol/mol (criterion 2). tolerant individuals were defined as those taking 2000mg metformin daily in divided doses, with no side effects. ten tolerant and ten intolerant individuals were recruited. participants gave written consent. they attended the research centre fasted from midnight. a baseline blood test was taken before a single dose of oral metformin was administered at 0900, with further bloods taken at 11 time points over the following 24 hours. a 24 hour urine collection was completed. blood samples were analysed for plasma metformin, and serum lactate concentrations.

Eligibility criteria:
inclusion criteria: * white european * type 2 diabetes * meet criteria for tolerance or intolerance as described exclusion criteria: * estimated glomerular filtration rate (egfr) \<60 * cognitive impairment * pregnancy * concurrent treatment with: acarbose, cephalexin, cimetidine, pyrimethamine, or tyrosine kinase inhibitors * history of gastric bypass * evidence of slowed gastric or intestinal motility

Keywords: metformin intolerance pharmacokinetics
personalized dc vaccine for postoperative cancer

Conditions: Gastric Cancer; Hepatocellular Carcinoma; Non-Small-Cell Lung Cancer; Colon Rectal Cancer

Summary: the study is aimed to the test efficacy and safety of neoantigen-primed dendritic cell (dc) cell vaccine therapy for postoperative locally advanced gastric cancer, hepatocellular carcinoma, lung cancer and colorectal cancer, and to explore the biomarkers related to efficacy and adverse event.

postoperative patients with pathological confirmed locally advanced gastric cancer, hepatocellular carcinoma, non-small cell lung cancer and colorectal cancer with standard adjuvant treatment are enrolled. this is a prospective exploratory trial. patients' tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. dc is in vitro primed with synthesized peptides. both adverse events and responses are recorded.

Eligibility criteria:
inclusion criteria: * participants with a first diagnosis of gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, colorectal cancer who have undergone a curative resection or ablation * anticipated life time \> 3month * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 * adequate organ functions exclusion criteria: * any evidence of tumor metastasis or co-existing malignant disease * tumor emergency * abnormal coagulation condition * contagious diseases, such as hepatitis b virus, hepatitis c virus, human immunodefficiency virus, tuberculosis infection * concomitant tumors * immunological co-morbidities

Keywords: cell therapy safety clinical efficacy adjuvant treatment locally advanced cancer
caudal versus intravenous dexmedetomidine for supplementation of caudal analgesia in children

Conditions: Inguinal Hernia; Cryptorchidism

Summary: the purpose of this study is to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on caudal levobupivacaine analgesia in children undergoing lower abdominal surgeries.

single shot caudal epidural block is one of the most widespread technique for pediatric pain management after infraumbilical surgical procedures.however, in a significant proportion of patients, despite good initial analgesia from a caudal block with local anesthetic, pain develops after the block resolves. dexmedetomidine is used increasingly in pediatric anesthesia practice to prolong the duration of action of caudal block with a local anesthetic agent.but which route of administration of clonidine is the most beneficial remains unknown. the investigators performed prospective randomized double-blind study to compare the effects of caudal dexmedetomidine with intravenous dexmedetomidine on postoperative analgesia after caudal levobupivacaine for inguinal herniorrhaphy or orchidopexy surgery. 90 children (asaⅰorⅱ,aged 2-5 yr) undergoing unilateral orchiopexy or inguinal herniorrhaphy were included in this study. anesthesia was induced with sevoflurane via a facemask, followed by placement of a laryngeal mask airway. anesthesia was maintained with sevoflurane 2-3% in oxygen-air.then,caudal block was applied. patients were randomly assigned in three groups. group cau-dex (n = 30): caudal levobupivacaine 0.25% 1ml/kg plus dexmedetomidine 1µg/kg and 10 ml normal saline i.v.;group iv-dex(n = 30): levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg(10 ml)i.v.;group placebo(n = 30): levobupivacaine 0.25% and 10 ml normal saline intravenous.

Eligibility criteria:
inclusion criteria: * asa status i-ii * aged 2-5 yr * undergoing unilateral orchiopexy/inguinal hernia repair exclusion criteria: * hypersensitivity to any local anesthetics * patient has history of allergy, intolerance, or reaction to dexmedetomidine * infections at puncture sites * bleeding diathesis * preexisting neurological disease * diabetes mellitus * children with uncorrected cardiac lesions * children with heart block or liver impairment

Keywords: dexmedetomidine postoperative pain reaction anesthesia children
evaluation of factors associated with return to sports activity six months after anterior shoulder stabilisation with latarjet.

Conditions: Shoulder Luxation

Summary: on a population of sports patients who had undergone a latarjet operation for post-traumatic anterior shoulder instability, reviewed in consultation 6 months after the operation as part of an ordinary follow-up and divided into two groups according to their current sports practice. group 1: "success": return to the same level in the same sport. group 2: "failure": return to the same sport with a reduced level or change of sport or significant reduction or cessation of sporting activity.

primary objective: to assess the impact of patients' psychological state on failure to return to sport. secondary objectives: * to compare the functional assessment of the shoulder of patients for whom return to sport is successful or unsuccessful (walch score, isokinetic tests and ckcues test score) * to describe the factors associated with failure to return to sport

Eligibility criteria:
inclusion criteria: * patient aged 18 years or older, having been informed of the research * sports patients who have expressed their desire to resume their sporting activity * patient who has undergone a first intention latarjet operation * patient regularly monitored since the operation and for whom all the data collected during the six-month follow-up visit are available exclusion criteria: * patient operated for revision surgery * patient with an associated rotator cuff or biceps injury * patient under court protection, guardianship or curatorship * patient who has indicated his opposition to the use of his medical data (by completing and returning the non-opposition form which will be sent to him)
effect of levodopa on postural motor learning in parkinson disease

Conditions: Parkinson Disease

Summary: the primary goal of this project is to gain a better understanding of whether and how levodopa (a common anti-parkinson disease medication) alters postural motor learning in people with parkinson disease. a secondary goal is to assess whether motor cortical excitability, measured via transcranial magnetic stimulation, is related to postural motor learning. participants with parkinson disease will complete between 50 and 100 postural perturbations (via support surface translations), on and off their dopamine replacement therapy (i.e. levodopa). adaptation of responses to these perturbations will be tracked. participants will also undergo transcranial magnetic stimulation to capture cortical excitability of the brain (in particular the motor cortex). cortical excitability will be correlated to adaptation of stepping (i.e. postural motor learning) on and off levodopa. investigators will also capture postural motor learning and cortical excitability in age-matched healthy adults. investigators hypothesize that dopamine will have a negative effect on postural motor learning, and the cortical excitability will be correlated to postural motor learning.


Eligibility criteria:
inclusion criteria: * between 18 and 90 years of age. * individuals with parkinson disease * healthy adults age-matched to pd participants * participants with pd will be currently taking dopamine replacement (i.e. levodopa) exclusion criteria: all subjects exclusion criteria: * deep brain stimulation * recent (within 6 months) orthopedic injuries influencing standing or balance * inability to stand independently transcranial magnetic stimulation exclusion criteria (for the subset of individuals taking part in the transcranial magnetic stimulation portion of the study): * history of epilepsy or currently taking any epileptic medication, * history of seizures * family history of epilepsy or seizures

Keywords: parkinson disease posture balance learning dopamine
diurnal variation of exogenous peptides (gh puls/jurgita i)

Conditions: Growth Hormone Deficiency

Summary: this is an exploratory trial with four cross-over arms measuring the pharmacokinetic and pharmacodynamic profiles of growth hormone using two different modes of growth hormone administration (subcutaneous infusion into the abdomen or subcutaneous bolus injection in the thigh) in 8 adult male or female patients with growth hormone deficiency during interval exercise or in supine rest. the order of dosing regimen within the groups and between the groups will be randomised. all patients will go through four different treatment sessions:a/b single subcutaneous bolus injection, supine rest without/with interval exercise, sessions c/d: continuous subcutaneous infusion, supine rest without/with interval exercise. hypotheses: 1) there is day-to-day variation of exogenous growth hormone, 2)concentration of growth hormone decreases due to exercise compared to supine rest, 3)there is a circadian variation in pharmacokinetics of exogenous growth hormone infused subcutaneously

the subjects will attend a screening visit and four treatment sessions. the dosing visits will comprise either 2-day hospital stay for the bolus injection group or 3 day hospital stay for the infusion group.

Eligibility criteria:
inclusion criteria: * aghd male or female subjects * stable gh replacement therapy for at least 3 months * body mass index 18,5 to 35.0 kg/m2 * achieved final height * age ≥ 18 years exclusion criteria: * known or suspected allergy to trial product or components of the trial product * subjects with active malignancy * severe cardiac insufficiency classified according to nyha iii-iv * unstable angina pectoris, acute myocardial infarction within the last 12 months * severe, uncontrolled hypertension: sitting blood pressure \> 180/110 mmhg * hba1c \> 7,5 % * impaired kidney function: plasma creatinine ≥ 150 umol/l according to the hospital lab. * impaired liver function: liver parameters exceed 2 times or more the upper normal limit, according to the hospital lab. * patients on insulin treatment * stable pituitary replacement therapy for less than 3 months * participation in any other clinical trial involving any investigational products within the last three months prior to this trial * any diseases judged by the investigator that could affect the trial * women of fertile age, who are pregnant, planning to become pregnant or breast-feeding. women of fertile age, who are not currently using adequate contraception methods such as: contraceptive pills, iud or who had not undergone hysterectomy or sterilization

Keywords: growth hormone deficiency circadian variation
insulin resistance and androgen deprivation therapy

Conditions: Prostate Cancer; Insulin Resistance

Summary: prostate cancer is the most common malignancy amongst men in united states. androgen deprivation therapy (adt) with long acting gonadotropin releasing hormone agonists is routinely used as adjuvant therapy in intermediate and high risk localized or locally advanced prostate cancer. since adt induces insulin resistance and diabetes, it is important that cellular and molecular effects of adt are investigated to define precisely the mechanisms involved in the pathogenesis of insulin resistance. pioglitazone, a known insulin sensitizer, may provide amelioration of insulin resistance in these patients.

investigators plan to conduct a prospective, randomized, double-blind, placebo-controlled trial in 44 men with nonmetastatic prostate cancer who are receiving adt with long acting gnrh agonist (study group). study subjects will undergo insulin clamp, subcutaneous fat biopsy, muscle biopsy, have a blood sample taken and fibroscan performed prior to randomization of study drug. they will then be randomized to 30 mg pioglitazone or placebo tablet daily for 6 months. blood samples will be drawn 2 and 4 months following the initiation of the study drug. the final study visit will be at 6 months. subjects will undergo clamp, fat biopsy, muscle biopsy, blood sampling, fibroscan and will be discharged from the study.

Eligibility criteria:
inclusion criteria: * prostate cancer, non-metastatic * have been on adt with long acting gnrh agonist continuously for last 3 months, and planning to continue adt for at least 6 months exclusion criteria: * used pioglitazone in last 6 months * heart failure nyha class 3 or 4 * known to have osteoporosis at this time. * history of bladder cancer * hemoglobin \<8 g/dl * egfr \<15 ml/min/1.73m2 * liver enzymes (alt or ast) \>3 times the upper limit of normal