Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of mk8266 in hypertensive men (mk-8266-002)

Conditions: Hypertension

Summary: this study evaluated adverse events (aes), study discontinuation due to aes, and pharmacodynamics of mk-8266 in male participants with mild to moderate hypertension.

this study evaluated aes, discontinuation due to aes, and effects on hemodynamic parameters, including systolic blood pressure (sbp) and aortic augmentation index (aix), following multiple oral doses of mk-8266. five serial panels, each consisting of eight participants (40 participants in panels a, b, c, d, and e), were randomized to receive either mk-8266 or matching placebo twice daily (bid) or three times daily (tid) for 10 consecutive days. although the original plan was to evaluate mk-8266 treatment in panels d and e using both bid and tid regimens, the study actually evaluated identical tid regimens in these panels.

Eligibility criteria:
inclusion criteria: * participant is male with essential hypertension (high blood pressure) * participant is in good general health (with the exception of hypertension) * participant has a body mass index (bmi) \<= 33 kg/m\^2 at the screening visit * participant has a platelet count \>= 150,000 cu/ml at the screening visit * participant has a positive aix at the screening visit exclusion criteria: * participant has a history of stroke, chronic seizure, or major neurological disease * participant has a functional disability that can interfere with rising from a seated position to the standing position * participant has any history of a bleeding or clotting disorder * participant has a history of cancer * participant is unable to refrain from or anticipates the use of any prescription or non-prescription medication * participant consumes excessive amounts of alcohol or caffeinated beverages daily

Keywords: hypertension
female experiences and brain activity

Conditions: Attention Deficit Hyperactivity Disorder; ADHD; Bipolar Disorder

Summary: the female experiences and brain activity study will investigate how different groups of people process information in different ways. using electro-physiological methods it will investigate differences in brain activity between women with adhd, women with bipolar disorder and those without a psychiatric illness. it will also investigate the relationship between patterns of brain activity, mood and functioning.

attention deficit hyperactivity disorder (adhd) and bipolar disorder (bd) affect approximately 2.5% and 1%, respectively, of the adult population in the uk. they represent a major clinical and economic burden on society. genetic and environmental risk factors (such as life events for bd); have been identified for each disorder. despite the highly different symptom presentations for adhd and bd, it has recently become clear that they share a cognitive characteristic, observed in high response time variability (rtv). this has led to the question of whether the increased rtv, which reflects short-term fluctuations in performance, is a non-specific marker for psychopathology or whether the causes for the higher rtv could differ across disorders. rtv has been identified as a possible early marker of psychopathology; therefore a better understanding of the underlying mechanisms could lead to improved diagnosis and prevention of negative consequences. further, it will give insight into the comorbidity observed between adhd and bd. this study will use cognitive-electrophysiological methods to investigate the causes for rtv and its association with other cognitive and neurophysiological impairments observed in each disorder (aim 1). the second question will address whether, within each disorder, current cognitive functioning relates to the patients' current social functioning (aim 2). adverse life events and other psychosocial risk factors can contribute to high variability in the level of social functioning observed, within and between individuals, in each disorder; yet our understanding of the association between current social functioning and cognitive functioning is limited. finally the study will explore if any cognitive differences detected by electrophysiological investigation are associated with any candidate gene markers for either disorder (aim 3).

Eligibility criteria:
inclusion criteria: * current clinical diagnosis of adult adhd * or current clinical diagnosis of bipolar disorder * or no history of psychiatric illness * white european descent exclusion criteria: * presence of a neurodevelopmental disorder * epilepsy * brain injury * dyslexia * limited proficiency in english language * iq\<70 * any current psychiatric medication use (with the exception of mood stabilisers or stimulant medication in the clinical groups)

Keywords: attention deficit hyperactivity disorder adhd bipolar disorder electrophysiological eeg erp attention motivation mood instability
very low calories ketogenic diet in migraine.

Conditions: Migraine; Overweight and Obesity

Summary: ketogenesis is a physiologic phenomenon due to starvation or ketogenic diet (kd), a drastic restricted carbohydrate dietary regimen that induces lipid metabolism and ketone body (kb) synthesis. we followed, in a dietician clinical setting, a group of migraineurs who randomly received a one-month prescription of experimental diet, followed by a one-month of carbohydrate progressive reintroduction, then another one-month of experimental diet, followed by a one-month of carbohydrate progressive reintroduction. experimental diets are a very-low calorie kd, or an isocaloric non-ketogenic diet. aim of our study is verify if during ketogenesis migraine improves.

the ketogenic diet (kd) is a high-fat, low-carbohydrate diet for long used to treat refractory epilepsy. ketogenesis, ketone-body formation, is a physiologic phenomenon also observed in patients following low-carbohydrate low-calorie diets for rapid weight loss. different authors evidenced a protective effect of ketone bodies also on migraine; however, kd effectiveness in this disorder is under scrutiny yet again. in fact, some concerns makes the matter a still open question: available studies were anecdotal, or conducted on small numbers; not all patients were diagnosed as migraineurs according to current headache classification; during ketogenesis there could be an avoidance of potentially trigger foods. moreover, to comply with ketogenic diet, great motivation is needed and often migraineurs did not have it. aim of this study is verify in a double blind parallel group cross over design if ketogenesis is really able to prevent/avoid headache attacks in episodic migraineurs. methods: thirty-five consecutive episodic migraineurs, with an attack frequency higher than 2 attacks per months, will be enrolled. two different kind of diet, a kd and a standard weight-loss diet (sd), will be consecutively administered in each patient recruited in the study for one month. randomly patients will start with kd or sd. at the end of the second month differences between diets will be detected. kd will consist of 4 daily pharmaceutical meal substitutes composed by low-carbohydrate, low-fat, rich in protein serving of food, already commercially available. sd will consist in a similar eating program, with serving of food with addition of carbohydrate to avoid ketogenesis.

Eligibility criteria:
inclusion criteria: * kept a headache diary for at least 1 month * migraine disease onset before the age of 50 * at least one migraine attack per month in the last 3 months * \<15 days/month with headaches. exclusion criteria: * prophylactic treatment in the previous 3 months * over consumption of acute anti-migraine medication (triptan, analgesic, or ergotamine) * pregnancy or lactation * type i diabetes * serious organic or psychiatric disorders that the investigators judged as having the potential to influence the trial evaluation.

Keywords: ketogenic diet very low calories diet ketone bodies
the effects of resveratrol supplementation on measurements of health and human performance

Conditions: Inflammation

Summary: the purpose of this study is to examine the effects of resveratrol on health and human performance. the study will evaluate cognitive function and several indicators of physical health before and after taking a resveratrol supplement or a placebo for three weeks.

measurements * blood laboratory parameters * cognitive assessment changes * body composition changes * vascular endothelial response

Eligibility criteria:
inclusion criteria: * men and women between 45 and 75 years of age * normal heart rate and blood pressure * ability to use personal computer interface * successful completion of physical activity readiness questionnaire exclusion criteria: * cardiovascular disease, uncontrolled hypertension, lung disease * inability to tolerate exercise * have taken grape related supplement in past 12 months * current use of drugs or dietary supplements to enhance exercise performance * allergy to wine, grape juice or grape seed supplements

Keywords: resveratrol insulin inflammation cognition metabolism
stars breast trial (study of anastrozole and radiotherapy sequencing pilot)

Conditions: Breast Cancer

Summary: this is a randomized study comparing the use of anastrozole before and continuing during radiotherapy for breast cancer compared to the use of anastrozole after irradiation.

adjuvant radiotherapy is well established as the primary modality to enhance local control in breast cancer. the use of adjuvant hormone therapy such as tamoxifen has shown to improve local control to a relatively minor amount on its own and does enhance local control of adjuvant radiotherapy. there is however, conflicting in vitro and clinical data regarding the effects of different sequences on tamoxifen and radiotherapy in terms of both local control and enhancement of radiotherapy toxicities. aromatase inhibitors such as anastrazole are establishing themselves as a class of drug superior to tamoxifen for the control of estrogen dependent breast cancers and overall are better tolerated with the exception of greater bone loss. as the key question is whether the sequencing of the aromatase inhibitor anastrozole alters local control by acting as an enhancer of the radiation breast cancer cell kill, it is therefore the aim of this study to compare 3 months of anastrozole prior to radiotherapy versus 3 months of anastrozole after radiotherapy with a specific objective of reducing the baseline ratio of in- field radiotherapy failure from 6% to 3%.this pilot study is preliminary to a planned long term study to investigate local failure. for the pilot a period of 6 months with all contributing centres open will provide a good test of recruitment matching estimates. 100 patients will provide a good sample to compare to the 270 tamoxifen treated women in the breast boost study for quality of life. it will also provide a 95% ci on the proportion of complying women in the order of ± 5% if 85 to 90 % of women comply.

Eligibility criteria:
inclusion criteria: * age 18 or more years. no upper limit. * post total mastectomy or lumpectomy. all planned surgery complete. * margins clear (no tumour contacting the inked margin) * tumour oestrogen or progesterone receptor positive * planned dose to irradiated volumes at least the biological equivalent of 45 gy in 25 fractions or more. * ecog 0-2 * patients post menopausal using same criteria as atac study. * written informed consent exclusion criteria: * previous radiotherapy to the area to be treated. * previous invasive malignancy within 5 years of current breast cancer diagnosis with the exception of cervix in-situ or skin cancer other than melanoma. * patients with clinical evidence of metastatic disease. * previous hormonal breast therapy. * ongoing hormone replacement therapy.

Keywords: breast cancer timing of radiotherapy local control
multi-center study to evaluate the performance of dermdx for primary care physicians in the detection of skin cancers

Conditions: Skin Cancer

Summary: the proposed study is a pivotal, multi-center retrospective reader study designed to determine whether the use of dermdx as a concurrent reading aid improves the performance of primary care physicians (pcps) in diagnosing skin cancers.

the proposed study is a pivotal, multi-center retrospective reader study designed to determine whether the use of dermdx as a concurrent reading aid improves the performance of primary care physicians (pcps) in diagnosing skin cancers. dermdx is a deep learning-based algorithm that analyzes lesion images to detect skin cancer. the software does not have dedicated hardware and can accept as input any dermoscopic images taken with commercial dermoscopes. because the study is designed to investigate the change in the performance of the pcps before and after seeing the device output, a single-arm study design has been used.

Eligibility criteria:
inclusion criteria: * the subjects must be primary care physicians who are board certified in family medicine or internal medicine. exclusion criteria: * subjects not meeting inclusion criteria.

Keywords: lesions artificial intelligence skin cancer malignant lesions benign lesions
liposomal bupivacaine single-injection interscalene block vs. continuous interscalene block for primary total shoulder arthroplasty

Conditions: Pain, Postoperative; Brachial Plexus Block

Summary: this study aims to assess analgesia efficacy between liposomal bupivacaine single injection interscalene blockade vs. continuous interscalene nerve block for patients undergoing primary total shoulder arthroplasty.


Eligibility criteria:
inclusion criteria * adult patients with an american society of anesthesiologists (asa) physiological status i-iii * patients presenting for unilateral primary total shoulder arthroplasty (includes anatomic and reverse total shoulder arthroplasty). * patients 18 years of age and older * able to provide informed consent for him or herself exclusion criteria * chronic pain syndromes * chronic opioid use (\>1 month) with ome \>5 mg/day or acute opioid use (\ 30 mg/day. * body mass index (bmi) \> 45 kg/m2 * severe drug allergy\* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib) and local anesthetics. \*defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever * personal or family history of malignant hyperthermia. * major systemic medical problems such as: * pre-existing severe renal disorder defined as glomerular filtration rate (gfr) \<50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history. * severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver * pre-existing medical history of moderate to severe pulmonary disease requiring medical therapy (obstructive and/or restrictive), use of home oxygen, preoperative baseline oxygen saturation \< 93% on room air. * history of contralateral hemidiaphragm dysfunction (e.g., paralysis) or phrenic nerve injury. * contraindication to a regional anesthesia technique (e.g., preexisting neuropathy+ in the operative extremity, coagulopathy, sepsis, infection at site of injection, uncooperative, and refusal). o + pre-existing neuropathy includes sensory and/or motor deficits due to nerve insult of surgical extremity, radicular symptoms of surgical extremity, history of unresolved brachial plexus injury/brachial plexopathy, and tumors of the brachial plexus. patients with nerve compression distal to site of surgery, such as history of carpal tunnel syndrome or cubital tunnel syndrome, are not considered contraindications to regional anesthesia. * known to be currently pregnant or actively breastfeeding++ o ++ all surgical patients are currently screened using a standardized pregnancy assessment tool (http://mayoweb.mayo.edu/sp-forms/mc8800-mc8899/mc8801-161.pdf) * impaired cognition (e.g. alzheimer's disease, moderate to severe dementia, encephalopathy) * non-english speaking

Keywords: interscalene nerve block total shoulder arthroplasty pain management obas qor-15
recharge sub-study to the implantable systems performance registry (ispr)

Conditions: Parkinson's Disease; Essential Tremor; Dystonia

Summary: the purpose of this study is to assess the recharge feature of the activa rc system in patients who are receiving deep brain stimulation (dbs) for parkinson's disease (pd), essential tremor (et), or dystonia.


Eligibility criteria:
inclusion criteria: * patient is enrolled in the implantable systems performance registry (ispr) and will receive one activa rc as their first implantable neurostimulator or as a replacement implantable neurostimulator for dbs. * patient must meet the indications in the activa rc labeling. * patient (or patient's legally authorized representative) signs and dates the appropriate recharge informed consent form and/or informed assent form and authorization to use and disclose health information (hipaa, us only). * patient has a diagnosis of parkinson's disease, essential tremor, or dystonia that meets the approved indication for activa rc in the applicable geography. * patient with dystonia is 7 years of age or older (eu only). * patient with either pd or et is 18 years of age or older. * patient (or caregiver) is able to use the patient programmer and correctly interpret the icons. * patient (or caregiver) is able and willing to regularly monitor the status of the rechargeable battery and respond appropriately. * patient (or caregiver) is able to locate the ins, position the recharge antenna for sufficient coupling, put on the recharge holster/belt, and monitor progress during the recharge session. * patient (or caregiver) is able to perform recharging activities for sufficient duration and frequency to maintain therapy and to perform recharging activities on an ongoing basis. * patient is willing and able to comply with protocol requirements. exclusion criteria: * patient has a contraindication identified in the activa rc labeling. * patient who is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of the recharge study. * patient has or will be implanted with a non-medtronic deep brain stimulation system component.

Keywords: parkinson's disease essential tremor dystonia (where indication is approved) deep brain stimulation activa rc
rct to reduce further falls and injuries for older fallers presenting to an emergency department

Conditions: Accidental Falls

Summary: this project is called "falls aren't us" and aimed at evaluating the effectiveness of a customised falls prevention program for people aged 60 and over who were presented to the hospital emergency department following a fall and being discharged home. recruitment for this randomized controlled trial has commenced in late december 2002 from several major public hospitals in the western, southern, and northern parts of melbourne metropolitan region. consented participants will receive a comprehensive falls risk assessment within one week of being discharged home from the emergency department and at twelve month following this initial assessment. their falls risks will be monitored for twelve months through a falls diary. following randomization, participants in the intervention group will receive a customised falls prevention program in addition to the usual care being put in place from the hospital emergency department.

older people presenting to an emergency department (ed) following a fall have high injury and hospitalisation rates. they are also at high risk of further falls and other adverse outcomes. however, there is currently limited available evidence to inform best practice. the primary aim of this project is to evaluate the effectiveness of a targeted multi-factor intervention in improving health and well being of older people who present to an ed after a fall. it also aims to identify those within this high-risk population most likely to benefit from the intervention program. approximately 800 people aged 60 years and over will be invited to participate at the emergency department from the end of september 2002. those who are eligible to participate will have a falls risk assessment in their own home and will be required to complete a falls diary for 12 months. there is a 50/50 chance (random allocation) that participants will receive an individualised falls prevention program. the duration of a falls risk assessment is up to 2 hours and there is no cost involved. participation in the research program will not affect routine management from the emergency department. becoming a participant may lessen the risk of having another fall and help others as well.

Eligibility criteria:
inclusion criteria: * presenting to the emergency department with the primary cause of presentation being a fall; aged 60 years or older; * discharged directly home following emergency care; living in the community or a retirement village; willing to take part in the study; * able to provide informed consent or has consent provided by a third party; able to comply with simple instructions; * able to walk independently indoors with or without a gait aid.
evaluation of recurrence risk of atrial fibrillation after cryoballoon ablation

Conditions: Atrial Fibrillation

Summary: the recurrence of atrial fibrillation(af) after pulmonary vein ablation with cryoballoon is conducted by many factors . the previous studies found larger left atrial and longer af duration are tied to higher risk of af recurrence. the characters of ablation procedure is also of critical importance to durable clinical success such as temperature features and time-to-isolation (tti). the aim of our study is to develop an tool of recurrence risk evaluation with both pre-procedure and procedure factors.


Eligibility criteria:
inclusion criteria: patients with paroxysmal af and accept cryoballoon ablation. exclusion criteria: * left atrium (la) diameter (anterior-to-posterior)\>55mm on transthoracic echocardiography (tte) * the presence of thrombus in the la or left atrial appendage (laa) on transesophageal echocardiography (tee) * uncorrected heart failure (nyha class iii or iv), * concomitant moderate or severe valvular heart disease or bioprosthetic valve, * malignancy necessitating chemotherapy.