Kornimate/medical-research-clean huggingface dataset:
heart rate changes during normal activity, exercise, and sleep in normal healthy subjects with and without epilepsy

Conditions: Healthy; Exercise

Summary: the purpose of this study is to gather ecg data during normal activity, exercise, and sleep from normal subjects with or without well-controlled epilepsy. this normal subject data will serve as "true negative" (i.e., no seizure occurring) challenge data for testing cardiac based seizure detection algorithms.

the purpose of this study is to gather ecg data during normal activity, exercise, and sleep from normal subjects with or without well-controlled epilepsy. this normal subject data will serve as "true negative" (i.e., no seizure occurring) challenge data for testing cardiac based seizure detection algorithms.

Eligibility criteria:
inclusion criteria: 1. subjects must be 18 years or older and may be of either sex and of any race. 2. subject must be in good general health, fully ambulatory, and able to complete the physical aspects of testing requirements. 3. subject must be willing and able to complete informed consent and hipaa authorization. 4. subject may be diagnosed with epilepsy but must be well controlled on their regular treatment regimen. 5. women of childbearing potential must have a negative urine pregnancy test. exclusion criteria: 1. subjects with skin abnormalities or conditions that would interfere with ecg electrode patch placement or cause subject discomfort with patch placement. 2. subjects report history of allergies or sensitivity to adhesive tapes or patches. 3. subjects with severe psychiatric disease that in the investigator's judgment would prevent the subject's successful completion of the study. 4. subjects with epilepsy experiencing status epilepticus within the last 6 months. 5. subjects with cardiovascular, respiratory, neuromuscular or gait disorders that in the investigator's judgment would cause unnecessary risk or inability to participate in the protocol. 6. subjects with known cardiovascular arrhythmias or cardiac disease resulting in history of cardiac disease or abnormal ecg recordings. these include, but are not limited to, conditions such as chronic atrial fibrillation and permanent cardiac pacemaker implantation. 7. use of beta adrenergic antagonists (i.e., "beta blockers") or calcium channel blocker agents that may affect heart rate. 8. subjects currently dependent on alcohol or narcotic drugs as defined by dsm iv-tr.

Keywords: healthy subject exercise study
effect of kinesio tape in muscle fatigue measured by biering-sorensen test

Conditions: Low Back Pain

Summary: muscle fatigue affects adversely the athletes´ performance and it is therefore one of the most investigated topics currently. however we do not know accurately the mechanisms that produce it. the aim of this study is to determine the influence of the kinesio taping (kt) application in the paravertebral muscle fatigue in a sample of healthy young subjects.


Eligibility criteria:
inclusion criteria: * more than 18 years * they were motivated to be included in the study exclusion criteria: * history of low back pain (lbp) in the last 6 months that had lasted for at least 1 week and / or had required medical attention and / or had been off sick * back surgery * been diagnosed with cardiovascular disease or neurological or herniations, protrusions or severe scoliosis * had pain from a disease presenting infection, tumor or injury of an anatomical structure involved in the test
remote ischemic preconditioning on pulmonary injury in cardic surgery

Conditions: Lung Injury; Remote Ischemic Preconditioning

Summary: during cardiac surgery with cardiopulmonary bypass , pulmonary dysfunction remains to be a problem complicating the postoperative course of the patients.remote ischemic preconditioning(ripc) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.recent several trials suggested that ripc could provide pulmonary protection by reducing serum biomarkers,however,whether the ripc can improve the clinical outcomes in patients undergoing on-pump cardiac surgery,is still uncertain. the study hypothesis is: remote ischemic preconditioning will provide lung-protective effect and improve clinical outcomes in patients undergoing cardic surgery.

remote ischemic preconditioning (ripc) protocol will be induced during anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood pressure cuff inflated to a pressure 200mmhg

Eligibility criteria:
inclusion criteria: 1. patients undergoing heart surgery on cardiopulmonary bypass 2. patients aged 18 years to 80 years exclusion criteria: 1. inability to give informed consent 2. preoperative severe impairment of respiratory function (arterial oxygen tension (pao2) \<60 mmhg or fev1\<50% predicted) 3. prior receipt of chemotherapy or radiation therapy or immunotherapy 4. left ventricular ejection fraction less than 30% 5. preoperative use of inotropics or mechanical assist device 6. patients with significant hepatic dysfunction (prothrombin\>2.0 ratio) 7. patients with known renal failure with a gfr\<30 ml/min/1.73 m2 8. recent myocardial infarction (within 7 days) 9. systemic or local active infections (either clinically defined or suggested by evidence such as elevated c-reactive protein levels, leukocytosis, or a body temperature\>38℃) 10. significant peripheral arterial disease affecting the upper limbs 11. surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,, off-pump surgery, emergency surgery
transcranial direct current stimulation (tdcs) and intensive therapy in aphasia

Conditions: Aphasia

Summary: intensive therapy for aphasia has been demonstrated to improve language functioning after stroke or other neurological injury. however, recovery is generally not complete and new therapies are needed to improve outcomes. transcranial direct current stimulation (tdcs) has been shown to improve outcomes with motor therapy after stroke. this study will examine the feasibility of using tdcs with intensive language therapy as a way of enhancing language outcomes in aphasia

intensive therapy for aphasia has been demonstrated to improve language functioning after stroke or other neurological injury. however, recovery is generally not complete and new therapies are needed to improve outcomes. transcranial direct current stimulation (tdcs) has been shown to improve outcomes with motor therapy after stroke. this study will examine the feasibility of using tdcs supplementing clinically determined intensive language therapy as a way of enhancing language outcomes in aphasia. eligible clients enrolled in the university of michigan aphasia program (umap) will be invited to participate in the study. clients will receive 20 minutes of tdcs every day along with their usual treatment protocol. pre and post testing will be completed to assess for improvement in language functioning. this is a feasibility and proof of concept study to determine if a randomized control trial should be pursued

Eligibility criteria:
inclusion criteria: * diagnosis of aphasia * enrolled in intensive therapy program at the university of michigan aphasia program. * ability to understand and give consent to treatment. exclusion criteria: * no metal implants or surgical devices * history of seizures * history of significant cognitive or psychiatric disturbance * participant cannot be pregnant at the time of study
nevirapine levels and fluconazole

Conditions: Nevirapine; Fluconazole; Adverse Event

Summary: nevirapine (nvp)-based antiretroviral therapy (art) has been commonly used in many developing countries due to its affordability and feasibility. nonetheless, the potential drug-drug interaction between nvp and fluconazole (flu) is a major concern. nvp can induce cytochrome p450 isoenzymes in the liver while flu inhibit the activity of this enzyme. the recent report has demonstrated that fluconazole significantly raises plasma nvp levels and may cause serious hepatotoxicity. conversely, nvp does not significantly influence the plasma level of flu. however, there have not been enough data or any recommendations to adjust nvp dosage for the concurrent use of both drugs in order to avoid the adverse events. a previous study has demonstrated that genetic disposition may play a role in nvp hypersensitivity reactions. there is little data of safety and tolerability for concurrent use of nvp and flu in asian populations. we therefore conducted this prospective observational study to compare the trough plasma nvp levels and frequencies of adverse events among antiretroviral hiv-infected patients who did not receive flu and received flu in different dosages for cryptococcosis prophylaxis or treatment; and subsequently received nvp-based art regimens.


Eligibility criteria:
inclusion criteria: 1. hiv-infected patients \>15 years of age, 2. naïve to antiretroviral therapy, 3. were initiated with a nvp-based art regimen, 4. used nvp 200-mg once-daily lead-in dose, prior to escalation to 200 mg twice daily. exclusion criteria: 1. creatinine level was higher than 2.0 mg/ml 2. liver aminotransferase enzyme was higher than five times of upper normal limit 3. receiving a medication that has drug-drug interactions with nvp or flu
an open-label, phase i/ii study of plena regimen in patients with unresectable pancreatic cancer or btc

Conditions: Pancreatic Cancer; Biliary Tract Cancer

Summary: immunotherapy of cancer based on pd-1/pd-l1 blockade has prompted a revolution in cancer clinical management, albeit as yet immunotherapy-based treatment approaches in pancreatic cancer and biliary tract cancer (btc) remain to have proven value, highlights the urgency for designing novel therapeutic strategies to combat these deadly diseases. the immunomodulatory effect of lenvatinib (lenvatinib is an oral multi-kinase inhibitor) on tumor microenvironments may contribute to antitumor activity of immune checkpoint blockade. this one-arm, phase i/ii study is designed to assess the safety and efficacy of the combined regimen of durvalumab (anti-pd-l1 antibody), lenvatinib and paclitaxel albumin (nab-paclitaxel).


Eligibility criteria:
inclusion criteria: 1.subjects must have histologically proven unresectable pancreatic cancer or biliary tract cancer 2.18 to 75 years old. 3.life expectancy of at least 6 months. 4.eastern cooperative oncology group performance status 0-2. 5.subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria. 6.subjects with anti-pd-1/l1 antibody treatment history are eligible which must be disease progression. 7.adequate organ function. 8.participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug. exclusion criteria: 1. subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2. serious uncontrolled medical disorders or active infections, pulmonary infection especially. 3. prior organ allograft. 4. women who are pregnant or breastfeeding. 5. women with a positive pregnancy test on enrollment or prior to investigational product administration. 6. subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Keywords: unresectable anti-pd-l1 antibody lenvatinib nab-paclitaxel
comparison between high-density electroencephalography and conventional electroencephalography for comatose patients

Conditions: Post Anoxic Coma

Summary: the purpose of this study is to measure whether high-density electroencephalography can improve the detection of electrophysiological signs of awareness compared to conventional electroencephalography in post-anoxic comatose patients


Eligibility criteria:
inclusion criteria: * post anoxic coma * over 18 years old * agreement from families * alive 4 days after the beginning of coma exclusion criteria: * traumatic coma * non-traumatic but not anoxic coma * patients with severe comorbidity previous to coma * refusal of families to participate to the study * contraindication to a high-density electroencephalography exam

Keywords: electroencephalography (eeg) mismatch negativity (mmn)
epidemiology of aeromedical evacuation

Conditions: Apoplexy; Femoral Neck Fracture; Myocardial Infarction; Subarachnoid Hemorrhage; Polytrauma

Summary: increasing air travel has resulted in a significant increase in aeromedical evacuation over the past decade. however there is only a small amount of epidemiological data available on the diagnosis, costs and transport characteristics of aeromedical evacuation cases. in the present study cases of aeromedical evacuation by a relief organization (workers' samaritan federation germany) were analyzed based on the following criteria: age, sex and diagnosis of the patient, ventilation mode, days of illness before transport, type of transport, flight routes, flying time, flight distance, type of aircraft, type and distance of connecting transport from the destination airport to the final hospital, total cost per repatriation, and costs per flight-minute of each transport type.


Eligibility criteria:
inclusion criteria: * medical emergency and aeromedical evacuation / repatriation exclusion criteria: * none

Keywords: aeromedical evacuation repatriation
pain management after surgery

Conditions: Pain, Postoperative

Summary: following outpatient orthopaedic surgery, adequate pain control is imperative both for patient satisfaction and for improved recovery and rehabilitation. opioids are frequently utilized for postoperative pain control, however they can be addictive and are known to have many deleterious effects. recent studies have demonstrated the effectiveness of a wide variety of multi-modal postoperative pain regimens in providing adequate pain control while also decreasing opioid usage. however, the most effective multi-modal pain regimen for postoperative pain control remains unclear. this prospective, randomized study intends to investigate the efficacy of a multi-modal postoperative pain regimen compared to a traditional opioid-only pain regimen following elective outpatient orthopaedic surgery of the hand, wrist, foot, or ankle.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * undergoing elective outpatient orthopaedic surgery under general anesthesia. exclusion criteria: * age \< 18 years old * non-english speaking * allergy to or medical contraindication to taking oxycodone (or other opioids), acetaminophen, or naprosyn (or other nsaids). * currently taking opioid medications * history of chronic opioid therapy for chronic pain * surgery being performed under local anesthesia only, without general anesthesia or sedation
effects of acupuncture on abdominal pain-related intestinal flora in patients with crohn's disease

Conditions: Crohn Disease

Summary: crohn's disease is an intestinal inflammatory disease, causing abdominal pain, diarrhea and other symptoms. the intestinal flora disorder is closely related to the occurrence and development of crohn's disease. acupuncture can induce remission of crohn's disease during mild to moderate active period, improve clinical symptoms such as abdominal pain. this study is to screen the intestinal bacteria related to abdominal pain in cd, and explore the effects of acupuncture on the intestinal flora related to abdominal pain in cd patients.

1. to screen the intestinal flora associated with cd abdominal pain. 2. to explore the effects of acupuncture and on abdominal pain and abdominal pain related intestinal flora in cd patients.

Eligibility criteria:
inclusion criteria: 1. aged 18-75, no gender limit; 2. disease in mild and moderate active period: 150≤cdai\<450 and meet at least one of the following: serum c-reactive protein (crp) levels ≥5mg/l, fecal calprotectin concentration≥250μg/g or endoscopic examination shows ulcers. remission period: cdai \<150 and meet at least one of the following: serum crp\<5 mg/l, fecal calprotectin concentration \<250μg/g or endoscopic examination shows no ulcer; 3. patients were not taking medication or were only taking one or more of the following drugs: mesalazine (≤4g/d and mesalazine was used for at least 1 month), prednisone (≤15mg/d and prednisone was used for at least 1 month) and / or azathioprine (≤1mg/kg/d and azathioprine was used for at least 3 month); 4. those who have not used biologics within 3 months before entering the study; 5. those who have never experienced acupuncture; 6. those who understand and agree to participate in this study and sign the informed consent form. exclusion criteria: 1. patients who are recently pregnant or in pregnancy or lactation; 2. patients with serious organic diseases; 3. patients diagnosed as psychosis; 4. patients who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial; 5. severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations; 6. there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications; 7. patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year; 8. there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.

Keywords: crohn disease gastrointestinal microbiome abdominal pain acupuncture
evaluate the safety and efficacy of ad-35 tablet in subjects with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: brief summary: this is a phase ii study to investigate the safety, preliminary efficacy and pharmacokinetics of ad-35 tablet in patients with mild to moderate alzheimer's disease. this study is to be run in china involving 21 sites. it will enroll approximately 480 patients to ensure 240 randomized with mild to moderate alzheimer's disease. the treatment period is 52 weeks and total study duration per patient is approximately 57 weeks.

in this multicenter, randomized, double blind, parallel-group, placebo controlled phase ii study, 240 patients with mild to moderate alzheimer's disease are planned to be enrolled and randomly assigned 1:1:1 to receive placebo, or different doses of ad-35 tablet (30 or 60 mg). after the first 26 weeks, subjects on active study drug will remain on the current doses, and subjects assigned to placebo will be randomized to receive 30 mg and 60 mg ad-35 tablet in a 1:1 ratio, respectively, for the second 26 weeks. this study will evaluate the safety, preliminary efficacy and pharmacokinetics of ad-35 tablets in patients with mild to moderate alzheimer's disease.

Eligibility criteria:
inclusion criteria: * men and women, 50-75 years of age. * formal education of five or more years. * diagnosed of probable ad in accordance with the nincds/adrda criteria (2011). * mild or moderate ad subjects: mmse score of 15-26 and cdr score ≥ 0.5 (cdr memory score ≥ 0.5). * subjects must have a brain magnetic resonance imaging (mri) scan that is consistent with a clinical diagnosis of probable ad. brain atrophy and medial temporal lobe atrophy visual assessment scale mta grading \>2 points. mild white matter degeneration may occur, but fazekas less than or equal to 2 points and supratentorial lacunar infarction lesions less than or equal to 3 points. * the total score of modified hachinski ischemia scale (mhis) ≤ 4. * hamilton depression scale (hamd) has a total score ≤ 17. exclusion criteria: * visual, hearing and verbal communication of subjects cannot meet the needs of cognitive function evaluation. * inability to tolerate mri procedures or contraindication to mri, (such as implanted in the body, mri incompatible pacemakers, implantable cardioverter defibrillators, cochlear implants, aneurysm clips, implanted injection pump, implanted nerve stimulator, metallic splinters in the eye, other magnetic, electrical and other metal implants) \[note\], or any other situation, in the judgment of the investigator, is not suitable for magnetic resonance imaging (mri). * the investigators believe that other severe or unstable conditions may interfere with the cognitive evaluation in clinical trials. * dementia caused by other reasons: vascular dementia, central nervous system infection, endocrine system diseases (such as thyroid disease, parathyroid gland disease) and other reasons.

Keywords: ad-35 tablet alzheimer's disease phase ii study
bhv-7000 acute treatment of bipolar mania

Conditions: Bipolar Disorder

Summary: the purpose of this study is to determine whether bhv-7000 is a safe and effective acute treatment for manic episodes in bipolar disorder i.


Eligibility criteria:
key inclusion criteria: 1. participant must be voluntarily hospitalized for a current manic episode. 2. male and female participants 18 years to 75 years of age at the time of the screening visit. 3. body mass index (bmi) must be ≥ 18 kg/m2 and ≤ 35 kg/m2. 4. meets dsm-5 criteria for bipolar disorder type i, with or without mixed features, as confirmed by mini interview with at least one well- defined prior mood episode (in addition to the current episode). the most recent prior manic episode must have occurred in the last 2 years. 5. episode of mania must not exceed 12 weeks in duration. 6. participants must be able and willing to discontinue all other psychotropic medications during the screening phase (e.g., antidepressant, antimanic, antipsychotic medications). key exclusion criteria: 1. rapid cycling is excluded as defined herein by subjects who have experienced ≥ 6 distinct mood episodes in a year. consecutive mood episodes must be demarcated either by a partial or full remission of at least 2 months' duration or by a switch to an episode of opposite polarity. each manic or mixed episode must have lasted at least 1 week, and each hypomanic episode must have lasted at least 4 days. 2. participants with a confirmed lifetime history of schizophrenia, psychotic disorders, dementia, delirium, amnesia, neurodegenerative disease, traumatic brain injury with clinically significant sequalae, seizure disorder, or other neurocognitive disorder. previous diagnosis of psychotic spectrum disorders are allowable if the investigator deems the diagnosis to be describing symptoms related to bipolar disorder. 3. any medical condition, based on the judgement of the investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.

Keywords: bipolar mania manic episode manic state bipolar disorder type 1 manic depressive manic bipolar mixed features mixed episode mixed mania bipolar episode