Kornimate/medical-research-clean huggingface dataset:
a clinical assessment study in x-linked myotubular myopathy (xlmtm) subjects

Conditions: X-linked Myotubular Myopathy

Summary: this is a pre-phase 1 prospective, non interventional clinical assessment study to evaluate xlmtm subjects aged 3 years and younger. many of these clinically relevant measures have not yet been routinely assessed in this population and may provide important insight on the natural history of xlmtm and for future evaluation of potential therapies.


Eligibility criteria:
inclusion criteria: * subject has a diagnosis of xlmtm resulting from a confirmed mutation in the mtm1 gene * subject is male * subject is aged less than 4 years * subject requires some mechanical ventilatory support (eg, ranging from 24 hours per day full time mechanical ventilation, to noninvasive support such as continuous positive airway pressure \[cpap\] or bilevel positive airway pressure \[bipap\] during sleeping hours) * access to subject's medical records * signed informed consent by the parent(s) or legally authorized representative(s) (lar) (when applicable) * subject and parent(s) or lar are willing and able to comply with study visits and study procedures exclusion criteria: * subject is participating in an interventional study designed to treat xlmtm * subject born \<35 weeks gestation who is still not to term as per corrected age * subject has a clinically important condition, or life-threatening disease other than xlmtm, in the opinion of the investigator * subject has received pyridostigmine or any medication to treat xlmtm within 30 days of enrollment

Keywords: mtm xlmtm
leeches for the treatment of knee osteoarthritis

Conditions: Osteoarthritis; Arthralgia

Summary: previous studies have not addressed the question, whether or not a repeated leeching can supply symptomatic relief of osteoarthritic pain for extended periods of time. we present a randomized study to the effectiveness of single and repeated leech therapy in cases with advanced osteoarthritis of the knee using a large patient group compared to a control group, who were both blinded to the actual treatment modality.


Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee * persistent osteoarthritic symptoms for at least 6 months * radiographic evidence of late stage osteoarthritis of the knee (stage iii-iv) * history of conservative management including pain medication and physical therapy exclusion criteria: * anticoagulant treatment or history of hemophilia * history or presence of rheumatic diseases leading to secondary osteoarthritis * presence of hematological, hepatic, renal or immunological disease * insulin-dependant diabetes mellitus * intraarticular injections or systemic application of corticosteroids during the 3 preceding months * history of surgery of the affected knee during the last 3 months or joint replacement * history of previous leech therapy * lack of informed consent

Keywords: osteoarthritis leeching randomized controlled trial arthralgia
study of ispinesib in subjects with breast cancer

Conditions: Neoplasms, Breast

Summary: the purpose of this research study is to find how breast cancer responds to the investigational drug, ispinesib. an investigational drug is a drug that has not been approved by the food and drug administration (fda) and is available for research use only. in particular, this study will try is to find the answers to the following research questions: 1. does breast cancer respond to ispinesib? 2. what are the side effects of ispinesib? 3. how much ispinesib is in the blood at specific times after it is taken?


Eligibility criteria:
inclusion criteria: * stage iiib or stage iv breast cancer * previously received anthracycline and taxane therapy exclusion criteria: * actively receiving anti-cancer therapy agent(s).

Keywords: breast cancer
cytokine profiles in children with obstructive sleep apnea

Conditions: Obstructive Sleep Apnea Syndrome

Summary: the purpose of this study is to compare the cytokine profile of tonsillar and peripheral blood mononuclear cells in patients with obstructive sleep apnea (osa) and to compare the blood mononuclear cell cytokine secretion profile between patients with obstructive sleep apnea and controls without apnea.

we will recruit subjects with osa about to undergo adenotonsillectomy and collect a blood sample and portion of their tonsils after the induction of general anesthesia. the mononuclear cells will be isolated from both these tissues and stimulated with different markers and cytokines assayed and compared. we will also recruit patients with no symptoms of osa undergoing unrelated elective surgery and ascertain the absence of osa by having the parents fill out a sleep questionnaire. we will then collect blood samples from these patients after the induction of anesthesia and examine the cytokine secretion profile and compare it to that of the children with osa.

Eligibility criteria:
inclusion criteria: * osa documented by polysomnography and clinical symptoms. * patients with no symptoms of osa and negative sleep questionnaire. exclusion criteria: * significant systemic disease except mild asthma

Keywords: pediatric obstructive sleep apnea syndrome
the relation between running patterns and overuse injuries in runners

Conditions: Overuse Injuries

Summary: running patterns are thought to have a major influence on the development of running related injuries (rri), however to studies have documented such relationship. thus, the aim of the study is to investigate the association between running patterns and overuse injuries in runners.

running patterns are thought to have a major influence on the development of running related injuries (rri). worldwide, running is a sport practiced by many individuals to improve cardio-respiratory function, health and well-being. although running positively contributes to health, there is also a risk of running related injuries (rri). at best, the consequence of rri´s is a periodic absence from physical activity, with the athlete returning to sport within weeks. in the worst case, the injury is a chronic painful condition, causing a sedentary lifestyle without physical activity. this is undesirable since physical inactivity increases the risk of lifestyle diseases and death. in denmark it is estimated that 4.500 deaths each year can be attributed directly to inactivity. furthermore, inactivity leads to reduced quality of life compared to active persons. to avoid people getting a sedentary lifestyle prevention of rri are necessary. to define a prevention strategy, one must have knowledge about risk factors and causation. many risk factors have been proposed. among these, running patterns and foot type are thought to play a major role in the development of rri. however, very few firm conclusions can be made based on the existing literature, often because of methodical problems. consequently, it is suggested to design large scale prospective studies controlling for multiple variables. furthermore, studies should differentiate between novice, elite and extreme runners. thus, the study design in this project will take these suggestions into account. the aim of the study is to investigate the association between running patterns and overuse injuries in runners.

Eligibility criteria:
inclusion criteria: * between 18 and 65 years old * has a gps-watch that can measure training data (garmin forerunner 205,305 or 405) * has registered their training (if they have run) for a period of at least three months before the inclusion in the trial * has an e-mail address exclusion criteria: * does not wish to keep a training diary * has not registered training data in the follow-up period * has had an injury in the leg within the last three months before baseline * active with another tough sports, cf. american college of sports medicine * psychic condition that does not allow participation * cannot read or understand danish

Keywords: running, overuse injury, limits humans
metobolomics in the characterisation of he

Conditions: Hepatic Encephalopathy; Cirrhosis

Summary: hepatic encephalopathy is (he) defined by the neurological and/or neuropsychological symptoms caused by an acute or chronic liver disease and/or a portosystemic shunt. its pathophysiology is still debated, although the synergic role of hyperammonemia and inflammation is now admitted for years. several additional mechanisms have been suspected, one of them being an altered permeability of the brain blood barrier (bbb). nevertheless, many aspects remain poorly understood. the rise of "-omics" techniques, and especially metabolomics, allowed to identify more precisely the different metabolic pathways that are involved in the pathophysiology of he. using a high flow chemistry technique and multivariate data analysis, metabolomics is an accurate way to understand the pathophysiology and pathogenesis of multifactorial diseases such as he. several studies have been published in cirrhosis. it has been suggested that serum metabolites at admission, as well as thyroxine, can predict advanced he in patients without brain failure. in a cohort including more than 600 patients, a higher microbially-derived metabolites, together with a lower thyroxine level, were associated with further development of brain failure. in another study from the same team, serum and urinary metabolites were significantly different in hospitalised patients who had developed poor outcome or not. another study conducted in the canonic cohort as also found changes in metabolites of patients with cirrhosis and acute-on-chronic liver failure (aclf), revealing mitochondrial dysfunction in peripheral organs that may contribute to organ failures. last, our team previously analysed plasma and cerebrospinal fluid (csf) samples of patients with cirrhosis and he hospitalised in intensive care unit (icu), showing alteration in ammonia and amino-acids metabolism, and also in energy metabolism. however, in the latest study, alcf grading was not available. as many of these patients were in a severe condition, one could hypothesize that the metabolomic changes observed in these patients may have been confounded by an aclf profile. therefore, the objective of this study is to characterize the metabolomic fingerprints of he in patients with cirrhosis, using 4 different groups of patients: patients with or without he, with or without alcf.


Eligibility criteria:
inclusion criteria: * patient aged ≥ 18 years * patient with cirrhosis of any etiology * informed patient who does not object to participating in the study * patient affiliated to a social security scheme or entitled beneficiary exclusion criteria: * pregnant or breast-feeding women * protected populations: under guardianship or trusteeship * previous liver transplant * patient on ame

Keywords: hepatic encephalopathy cirrhosis metabolomics
comparison of the effects of continuous epidural analgesia and continuous intravenous analgesia on postoperative bowel movement in patients undergoing laparoscopic gastrectomy

Conditions: Gastric Cancer

Summary: the investigators hypothesized that sympatholytic effect of epidural analgesia would attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by pneumoperitoneum during laparoscopic surgery. this study is to compare the effect of epidural analgesia and intravenous analgesia on postoperative bowel movement in patients undergoing laparoscopic gastrectomy.


Eligibility criteria:
inclusion criteria: * patient between 20 and 70 of age with asa physical status ⅰ-ⅲ * gastric cancer patient undergoing laparoscopic gastrectomy exclusion criteria: * asa physical status ⅳ * bradycardia (\< 60 bpm), arrhythmia * uncompensated heart failure * hepatic failure (child-pugh score b) * renal failure (egfr mdrd \< 60 ml/min/1.73m2)
effect of muscle damage after downhill running on postprandial lipids

Conditions: Nutritional and Metabolic Diseases; Lipemia

Summary: all participants underwent three experimental trials, namely downhill running (dr), level running (lr), and the control (con) in a cross-over design. each trial lasted for 2 days. the participants were fed the same breakfast and lunch on day 1 in each trial. the participants arrived at the laboratory at 18:00 on day 1 and ran on the treadmill at 60% vo2max (downhill and level surface trials) or rested (con trial) for 30 min. subsequently, they were fed a standardized dinner (a meal box containing chicken, vegetables, and rice, 692 kcal, with 50% energy from carbohydrate, 32% from fat, and 18% from protein) within 20 min. the participants returned to the laboratory at 07:30 on day 2 after an overnight fast. after baseline blood and gas samples were collected, the participants were fed a high-fat meal that included cereal, white bread, whipping cream, cheese, and butter. the high-fat meal provided fat 1.2 g/kg (65% energy), carbohydrate 1.1 g/kg (27% energy), protein 0.33 g/kg (8% energy), and 16.5 kcal/kg. a 10-ml blood sample was collected from a forearm vein into nonheparinized tubes before and immediately after exercise or rest on day 1. on day 2, postprandial blood samples were collected from forearm veins into nonheparinized tubes by using an indwelling venous needle and a three-way stopcock. a 10-ml blood sample was collected before (0 h) and 0.5, 1, 2, 3, 4, 5, and 6 h after the high-fat meal.


Eligibility criteria:
inclusion criteria: * generally healthy, had not engaged in regular exercise or received any medication in the past 6 months exclusion criteria: * history of cardiovascular disease, hypertension, hyperlipidemia, diabetes, atherosclerosis, or osteoporosis, free of any musculoskeletal injury during the study

Keywords: triglyceride non-esterified fatty acids eccentric exercise cardiovascular disease
a phase ii study of anlotinib in mtc patients

Conditions: Tumor

Summary: anlotibib (altn) is a kind of innovative medicines approved by state food and drug administration（sfda） which was researched by jiangsu chia-tai tianqing pharmaceutical co., ltd. altn is a kinase inhibitor of receptor tyrosine with multi-targets, especially for vegfr2 and vegfr3. it has the obvious resistance to new angiogenesis. the trial is to explore altn for the effectiveness of advanced medullary thyroid carcinoma and security.


Eligibility criteria:
inclusion criteria: * 1.late medullary thyroid carcinoma; 2.18-70years, ecog:0-2,expected survival period \>3 months; 3.calcitonic≥500pg/ml, thyroid function normal; 4.hb≥100g/l,anc(absolute neutrophil count) ≥1.5×109/l；plt * 80×109/l ,bil/cr in normal range,alt/ast(aspartate aminotransferase )≤1.5\*uln(for hepatic metastases,alt/ast(aspartate aminotransferase )≤5\*uln) ;tg≤ 3.0mmol/l，cholesterol≤7.75mmol/l; lvef * lln. 5.username contraceptive during the study and after 6 months; 6.volunteer. exclusion criteria: * 1.received vascular endothelial growth inhibitor type of targeted therapy; 2.subject was diagnosed with the second cancer; 3.participated in other clinical trials in four weeks; 4.received in other radiotherapy or chemotherapy treatment in four weeks; 5.with ae\> 1; 6.has influence of oral drugs; 7.brain metastases, spinal cord compression, cancerous meningitis, or the brain/soft meningeal disease patient; 8.any serious or failed to control the disease 9.artery/venous thrombotic; 10.coagulant function abnormality; 11.arteriovenous thrombosis event; 12.history of psychiatric drugs abuse or a mental disorder; 13.immunodeficiency history; 14.concomitant diseases.
effect of the fixed dose combination amlodipine/valsartan on central aortic blood pressure in uncontrolled essential hypertension with amlodipine 5 mg

Conditions: Hypertension

Summary: assess that for an equivalent brachial blood pressure (bp)lowering, a fixed dose combination amlodipine/valsartan based regimen reduces central aortic bp pressure to a larger extent than an atenolol/amlodipine combination based regimen.


Eligibility criteria:
inclusion criteria: * male or female patients 18 years of age or older * hypertension defined by msdbp \> 90 and or mssbp \> 140 mmhg, msdbp \> 80 mmhg, or/and mssbp \> 130 mmhg if diabetes or chronic renal impairment uncontrolled under their previous therapy, or untreated , or experiencing unacceptable side effects * written informed consent to participate in the study prior to any study procedures exclusion criteria: * severe hypertension (grade 3 who classification msdbp \> 110 mmhg and/or mssbp \> 180 mmhg) * evidence of a secondary form of hypertension * type 1 diabetes mellitus * history of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.
a study of zstk474 in japanese patients with advanced solid malignancies

Conditions: Neoplasms

Summary: to evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of zstk474 in patients with advanced solid malignancies.

open-label, uncontrolled, serial cohort, dose-escalation study evaluating two different dosing regimens (arm 1: cycles of 5 days on drug and 2 days off drug), arm 2: cycles of 21 days on drug and 7 days off drug).

Eligibility criteria:
inclusion criteria: * japanese males or females \>= 20 years old * advanced (metastatic or unresectable) solid tumor * ecog performance status score of 0 or 1 and expected survival \>12 weeks * recovered from hematological toxicities of prior cancer therapies exclusion criteria: * previous treatment with pi3k inhibitor * serious/significant illnesses or underlying conditions, including diabetes or hepatic renal or cv disease. * other investigational agent within previous 4 weeks * participating in another clinical study

Keywords: pi3k inhibitor clinical trial
defining the best approach to block the pain after knee surgery

Conditions: Pain, Postoperative

Summary: the study aims to compare standard techniques used to control pain after knee surgery. the investigators hypothesize that the fascia iliaca block is faster, safer and as good as or better than the femoral block, with or without a stimulating catheter.

60 patients being treated for acl repair or knee arthroplasties under regional anesthesia will be randomized to three groups: fascia iliaca block (fib), femoral block (fb) with stimulating catheter or fb without stimulating catheter. a catheter will be placed according to each technique, before the surgery. a bolus of local anesthetic will be given pre-surgery and at the end of the operation, in all groups. a continuous infusion will be started for 48 hours. all patients receive a standard analgesia cocktail and rescue medication. pain and level of activity, as well as side effects, will be evaluated.

Eligibility criteria:
inclusion criteria: * patients coming for acl or knee prosthesis surgery * between 18-80 years old * consenting for spinal anesthesia exclusion criteria: * major neurologic diseases * obesity with body mass index (bmi) \> 30 * infection at the punction sites (back and/or groin) * diabetes mellitus for longer than 5 years * coagulopathy

Keywords: femoral block fascia iliaca block acl repair post-operative analgesia knee surgery acl damage knee damage
adapta pacing system clinical study

Conditions: Pacemaker; Bradycardia

Summary: pacemakers are implantable devices that pace (electrically stimulate) the heart. some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow). advances in pacemaker technology in recent years include features that automatically adapt to patient conditions without intervention from the clinician. adapta (model #addr01) is a new pacemaker that is designed to provide further automaticity advances by including the managed ventricular pacing (mvp) feature designed to promote intrinsic conduction (natural flow of electricity in the heart) by reducing unnecessary ventricular (lower chamber of the heart) pacing (electrical impulses). adapta also contains a feature called therapyguide that is designed to allow the user to select certain conditions for each subject and receive a list of suggested pacemaker parameter value changes based on those conditions. the purpose of this study is to evaluate the overall system safety and clinical performance of the adapta pacing system.


Eligibility criteria:
inclusion criteria: * subjects who have a class i or ii indication for implantation of a dual chamber pacemaker according to acc/aha/naspe guidelines * subjects who have signed a medical ethics committee (mec) approved informed consent form exclusion criteria: * subjects with a mechanical tricuspid valve * subjects with a life expectancy less than two years * subjects with a class iii indication for permanent pacing * subjects with lead integrity problems, unless leads are being replaced

Keywords: pacemaker managed ventricular pacing ventricular pacing
a portal-based advance care planning intervention among community-dwelling persons living with cognitive impairment

Conditions: Advanced Care Planning

Summary: the purpose of this research is to examine the feasibility of using a patient portal based advance care planning (acp) tool to improve acp discussions and documentation in persons living with cognitive impairment in outpatient primary care.

the goal of this study is to explore whether sending a portal-based acp tool (called acpvoice) paired with a motivational message within the patient portal before a routine primary care physician visit can improve acp discussions and documentation within the electronic health record among persons living with cognitive impairment in outpatient primary care.

Eligibility criteria:
inclusion criteria: * age 65 years old and older * diagnosis of recognized or probable mild cognitive impairment or mild dementia or elevated eradar score * completed visit with their primary care provider (pcp) within the past 12 months and have upcoming pcp visit in next 6 months * have an active patient portal account exclusion criteria: * lives in a long-term care facility * severe vision impairment/blindness (as they need to be able to read portal messages) * enrolled in hospice * lacks decisional capacity as deemed by pcp

Keywords: advance care planning mild cognitive impairment dementia patient portal