Kornimate/medical-research-clean huggingface dataset:
comparison of 4.0 mg/kg sugammadex at 1-2 post tetanic counts (ptc) in renal or control patients (19.4.328)(p05769)

Conditions: Anesthesia

Summary: the current trial was designed to investigate the effects of 4.0 mg.kg-1 of sugammadex on efficacy, safety and pharmacokinetics in subjects with severe renal impairment in comparison to subjects with normal renal function.

the results of previous trials showed that the safety profile of sugammadex observed in subjects with impaired renal function are not appreciably different from subjects with normal renal function. reoccurrence of neuromuscular blockade was not observed, and sugammadex was safe and generally well tolerated in subjects with severe renal impairment. in a previous trial, subjects (n=15) with severe renal impairment received a dose of 2.0 mg.kg-1 of sugammadex. the effects of the other proposed recommended dose for routine reversal, 4.0 mg.kg-1, on efficacy, safety and pharmacokinetics had not been studied thus far in subjects with severe renal impairment. the objectives of this trial were to assess equivalence with respect to the efficacy of sugammadex in subjects with normal renal function or severe renal impairment, to evaluate the safety of sugammadex in these subject groups and to compare the pharmacokinetic profiles.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * asa class 1-3 * creatinine clearance (clcr) \< 30 ml/min and no anticipated clinical indication for high flux hemodialysis during first 24 hours after sugammadex administration (for renally impaired group) or clcr \>= 80 ml/min (for control group) -scheduled for a surgical procedure under general anesthesia with propofol requiring neuromuscular relaxation with the use of rocuronium * scheduled for a surgical procedure in supine position * written informed consent exclusion criteria: - subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant hepatic dysfunction * subjects scheduled for renal transplant surgery * subjects known or suspected to have a (family) history of malignant hyperthermia -subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia * subjects receiving fusidic acid, toremifene and/or flucloxacillin * subjects who have already participated in a sugammadex trial * subjects who have participated in another clinical trial, not pre-approved by the sponsor, within 30 days of entering into 19.4.328 (p05769) * female subjects who are pregnant * female subjects who are breast-feeding
adjunctive sertraline for the treatment of hiv-associated cryptococcal meningitis

Conditions: Cryptococcal Meningitis; Fungal Meningitis

Summary: this is a phase iii trial to determine whether adjunctive sertraline will lead to improved survival 18-week survival. there was an initial phase i/ii unmasked dose finding pharmacokinetic study of csf concentrations in 172 persons conducted from august 2013 to august 2014. see nct03002012.

this is a phase iii randomized trial to evaluate whether sertraline when added to standard amphotericin-based therapy for cryptococcal meningitis, will lead to improved survival . cryptococcal meningitis diagnosis will be made via csf cryptococcal antigen (crag) at time of lumbar puncture (lp) with confirmation by csf culture. after informed consent, subjects that meet eligibility requirements will be able to enter study. a non-randomized phase i dose-escalation study will first be conducted to help optimize dosing for a larger randomized phase ii study. phase iii design: subjects will be randomized to standard induction therapy with masked placebo or sertraline at 400mg/day. we will use a permutated block randomization in a 1:1 allocation (n=275 per arm). total anticipated enrollment: 550 subjects.

Eligibility criteria:
inclusion criteria: * cryptococcal meningitis diagnosed by csf cryptococcal antigen (crag) * hiv-1 infection * ability and willingness of the participant or legal guardian/representative to provide informed consent * willing to receive protocol-specified lumbar punctures exclusion criteria: * age \< 18 years * receipt of \>=3 doses of amphotericin therapy * cannot or unlikely to attend regular clinic visits * history of known liver cirrhosis * presence of jaundice * pregnancy * current breastfeeding

Keywords: cryptococcal meningitis cryptococcus meningitis yeast fungus
single dose escalation study of cm383 in healthy volunteers

Conditions: Alzheimer Disease

Summary: this study is a single center, randomized, double-blind, placebo-controlled phase i clinical study in a single dose escalation to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of cm383 in male healthy subjects.

alzheimer's disease (ad) is the most common type of dementia, which is a degenerative disease of the central nervous system with insidious onset and progressive development. its clinical features mainly include memory impairment, cognitive impairment, psychobehavioral abnormalities, and social decline.

Eligibility criteria:
inclusion criteria: * healthy males, voluntarily participate; * 18 and 80 years old (including boundary values); * able to communicate well with the researchers and follow up the protocol requirements. exclusion criteria: * the average daily smoking volume within three months before screening is greater than 5 cigarettes; * excessive alcohol consumption within three months before screening, or positive alcohol breath test; * urine drug abuse screening is positive; * having a family planning or sperm donation plan; disagree to adopt efficient contraceptive measures.
orthostatic hypotension in rehabilitation patients

Conditions: Hypotension, Orthostatic

Summary: the purpose of this study is to determine the prevalence and clinical course of orthostatic hypotension (oh) on a rehabilitation and nursing home unit during their inpatient stay and to initiate a standardized, interdisciplinary treatment plan for patients with oh and determine the effect of treatment on the clinical course of oh during their inpatient stay.

this study is a prospective, quasi-experiment conducted in two consecutive phases. during the observation phase, eligible patients are identified and followed through their usual course of care in the nursing home/rehabilitation unit. during the intervention phase, patients enrolled who have oh will receive the intervention. patients will be enrolled over two research phases and the investigators expect to evaluate 459 subjects. this research program will occur over a three-year period. methods: during phase i, baseline prevalence and natural history of oh will be determined by: enrolling consecutive appropriate subjects (able to stand, not end of life care) from a rehabilitation and nursing home unit and measuring oh 3 times weekly over their inpatient stay. in addition, chart review of diagnoses, medications, functional status, nutrition, and adverse events will be evaluated and correlated with clinical status. during phase ii, the investigators will implement a standardized, interdisciplinary (md/rn/pt/dietician) treatment plan for patients with oh. this will include chart review of diagnoses, medications, functional status, nutrition, adverse events, and correlation with clinical status. the goals of the interventions are to identify and treat the underlying causes of oh in rehabilitation patients. based upon the comprehensive assessment, intervention participants will receive a standardized, interdisciplinary treatment regime.

Eligibility criteria:
inclusion criteria: * admitted to vancouver va nursing home or rehabilitation ward exclusion criteria: * unable to stand upon admission * hospice admission * respite admission

Keywords: aging blood pressure hypotension orthostatic rehabilitation
cupping therapy for neck pain in cervical spondylosis

Conditions: Neck Pain; Cervical Spondylosis

Summary: cervical spondylosis is one of the common causes of chronic neck pain. it can significantly affect the quality of life, lead to disabilities, and increase the economic burden on patients. treatment mainly includes pain relievers, non-steroidal anti-inflammatory drugs (nsaids), muscle relaxants or physical therapy. the condition tends to recur frequently; therefore, long-term use of medication can lead to unwanted effects on the digestive system, kidneys, and cardiovascular system. dry cupping therapy is a non-pharmacological method that has been shown to be effective in pain management. cupping therapy has the advantage of being applicable to patients who are afraid of needles and has a wide area of effect. given the limitations in evaluating treatment effectiveness and safety, along with the lack of published research discussing the analgesic effects of dry cupping for neck pain caused by cervical spondylosis, the investigators conducted the study on pain reduction and safety of cupping therapy in patients with neck pain caused by cervical spondylosis.

patients diagnosed with cervical spondylosis who have neck pain will be registered for this study. they will be treated with electroacupuncture or cupping therapy. the intervention period is two weeks. electroacupuncture will be performed five times a week while cupping therapy will be performed once every 3 days. data on the visual analog scale (vas) and side effects of electroacupuncture and cupping therapy will be recorded before the study and weekly for 2 weeks.

Eligibility criteria:
inclusion criteria: * individuals between the ages of 20 and 60 years, outpatient treatment. * individuals diagnosed with cervical spondylosis. * individuals report pain intensity between 3 and 8 according to on the visual analogue scale (vas) on the screening visit day. * experiencing neck pain for no longer than four weeks. * individuals who volunteered to participate in the study and signed a consent form. exclusion criteria: * patients diagnosed with acute or chronic neck pain due to specific causes or with root compression syndrome, spinal cord compression syndrome, or vertebral artery syndrome. * patients loss of normal cervical curvature or deformity. * individuals with a history of neck trauma, cervical vertebra fracture, or cervical spine surgery, congenital spinal abnormalities, systemic bone and joint diseases. * patients have undergone cupping therapy, plastering, or drug inhalation within one week prior to participating in the study. * patients used of medications that could affect research outcomes within one week: pain relievers, muscle relaxants, traditional medicines for treating neck pain. * patients suffer from a mental illness or lacks consciousness. * patients have a pacemaker, or any metal devices such as screws or plates. * patients currently using anticoagulant medications or has a bleeding disorder.

Keywords: neck pain cupping therapy cervical spondylosis
the effect of activity feedback enabled by smart watches during in-patient stroke rehabilitation

Conditions: Stroke

Summary: the amount of activity completed by individuals within rehabilitation programs, even when units are well staffed, is often far below that required for optimal stroke rehabilitation, and is not individually adapted on a day-to-day basis. daily feedback on their activity levels may motivate stroke survivors to engage in greater skills practice and thus outcome after stroke. to date only a few trials suggests that augmented feedback may be effective. there is a need for a large pragmatic trial to explore the impact of augmented activity feedback on top of their standard care. the purpose of this study is to determine the effect of augmented activity feedback by smart watches to support in-patient stroke rehabilitation.

this study had a feasibility and pilot development phase from september 2015 to april 2016, and then moved into the main study with some changes in design and execution occurring in the light of experience. its execution has also been constrained by external factors beyond control. it is in essence asking whether wearing a smart watch which gives feedback on activity every two hours, with a specific target tailored to the patient's performance 24 hours earlier will be associated with a higher rate of physical activity than seen in people wearing the same watch without and feedback been given. the intervention only lasts unto 21 days, but earlier discharge will terminate that patient's participation sooner. a telephone interview at 12 weeks after entry collect data on mobility. outcome measures will assess mobility, activity, and health status.

Eligibility criteria:
inclusion criteria: * admission for acute/sub-acute in-patient neurorehabilitation of a first stroke at the 2nd affiliated hospital of anhui university of traditional medicine and acupuncture, hefei, china. * time from onset of stroke to admission for rehabilitation \<16 weeks. * ability to follow a two stage command; pick up an object, put object on table. * independent in mobility prior to admission. subjects can use any type of assistive device and brace needed. * able to understand and repeat information related to the informed consent. exclusion criteria: * admission for second stroke. * subjects who are unable to provide consent due to a cognitive impairment.
prospective, multicenter, observational study of apatinib single or combined capecitabine for treatment of patients with metastatic her-2 negative breast cancer

Conditions: Breast Cancer Metastatic

Summary: the purpose of this study is to assess the efficacy and safety of patients who receive apatinib single or combined capecitabine for treatment of patients with metastatic her-2 negative breast cancer.


Eligibility criteria:
inclusion criteria: * 18 to 70 years old (female) * eastern cooperative oncology group (ecog) performance status of 0-2 * pathologically diagnosed with her-2 negative, er/pr negative, er/pr positive after the failure of endocrine treatment, and had not more than three chemotherapy regimens (must include anthracycline-based and yew class), and the final failure of chemotherapy regimens in patients with advanced breast cancer; note: treatment failure include (1) during or after the completion of six months or less disease progress of neoadjuvant or adjuvant therapy; (2) rescue treatment in progress within 3 months or less * patients with at least one measurable lesions of the advanced breast cancer， measurable lesions has not received radiotherapy or other treatment, unless progress after treatment (measuring≥10mm on spiral ct scan, satisfying the criteria in recist1.1 and who); * major organ function has to meet the following certeria: 1. for results of blood routine test (without blood transfusion within 14 days) 1. hb≥100g/l; 2. anc≥1.5×109/l; 3. plt≥75×109/l; 2. for results of blood biochemical test： 1. tbil\<1.5uln； 2. altand ast\<2.5uln, but5\<uln if the transferanse elevation is due to liver metastases； 3. serum creatinine ≤1.25uln , or calculated creatinine clearance\>45 ml/min(per the cockcroft-gault formula); 6.participants were willing to join in this study, and written informed consent. exclusion criteria: 1. the patients with the failure of capecitabine treatment； 2. the patients with chest wall invasion, or chest wall large canker has a tendency to transfer； 3. have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure \> 140 mmhg, diastolic blood pressure \> 90 mmhg), with classⅱand above coronary heart disease, unable to control arrhythmia (including qtc lengthened women \> 470 ms) and classⅲ-ⅳcardiac insufficiency; or left ventricular ejection fraction (lvef) \< 50%； 4. a variety of factors influencing oral drugs (such as unable to swallow, after resection of the gastrointestinal, chronic diarrhea and intestinal obstruction, etc.)； 5. has a history of bleeding, the clinical significance of bleeding symptoms, patients with definite bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers, baseline period （+ +）and above of defecate occult blood, vasculitis, etc； 6. received a major surgery within 4 weeks or severe traumatic injury, fractures, or has a poor healing wound； 7. allergic to apatinib and supplementary material； 8. patients with active brain metastases; 9. patients with pregnant or planning a pregnancy; 10. the researchers think inappropriate.
fecal microbiota transplantation for irritable bowel syndrome associated food intolerance

Conditions: Irritable Bowel Syndrome; Fecal Microbiota Transplantation

Summary: previous studies have shown that stool transplantation (fmt) have positive effect in symptoms for some patients with irritable bowel syndrome (ibs). studies have shown that it is possible by fmt to reverse the microbiome of the recipient's intestine in the direction of the microbiome of the donor. the effect on eating habits for engraftment of microbiome by fmt is unknown. the purpose of this study is to investigate whether fmt relieves fodmap diet extension without worsening intestinal symptoms in ibs patients.

this is a plasebo controlled study in which we study the effect and safety of fmt in patients who have ibs and have used fodmap diet. fmt is assessed by colonoscopy route and therafter the patietns receive twice fmt enema from healthy donor or plasebo..

Eligibility criteria:
inclusion criteria: * adults, age 18-75 years, knowledge of the finnish language * ibs patients have been diagnosed with the rome iv- criteria, all ibs-subtypes will be accepted to the trial * the patient must consume low fodmap diet to control ibs symptoms * patient must sign the informed consent exclusion criteria: * diagnosed allergies to food components in the study dietary protocol * pregnancy and breastfeeding * antibiotic treatment less than three months prior enrolment * faecal incontinence, i.e., inability to retain enema * abuse of drugs, alcohol or medications * other diagnosis besides ibs causing gi symptoms, these include ibd, microscopic colitis, coeliac disease and bile acid diarrhoea. * severe psychiatric or neurologic condition decreasing patient's compliance

Keywords: fmt ibs fodmap
finding the right tenofovir/emtricitabine regimen for pre-exposure prophylaxis (prep) in transgender women

Conditions: HIV Prevention

Summary: this is an open-label, steady-state study of tenofovir (tfv) and emtricitabine (ftc) pharmacokinetics (pk) in transgender women taking feminizing hormones. half of the participants will be transgender women on feminizing hormones, the other half will be male volunteers not taking any hormone therapy.

the investigators propose an open-label, steady-state study of tfv and ftc pk in blood and colon tissue in healthy tgw on feminizing hormones to be compared to healthy cis men, all at risk for hiv infection. research participants will already have received eight days of tdf/ftc dosing. evaluating tdf and ftc pk at steady-state is important as it reduces inter-individual variability since the rate of phosphorylation of tfv and ftc is highly variable, resulting in highly variable tfv-dp and emtricitabine-triphosphate (ftc-tp) pk among individuals in the first day and during rise to steady-state.

Eligibility criteria:
inclusion criteria: * tgw and cis men (male at birth and not a tgw) * 18 to 65 years of age, inclusive on the date of screening * provides informed consent for the study * non-reactive hiv test results within four weeks of enrollment * an estimated calculated creatinine clearance (eccr) of at least 70 ml/min * agrees to use condoms for all sexual events during study participation. * taking daily oral truvada® (tenofovir disoproxil fumarate (tdf) 300 mg/emtricitabine (ftc) 200 mg) for at least one week at the time of study pk sampling visit * tgw have to be on an estradiol and have a serum total estradiol level \> 100 picograms(pg)/ml exclusion criteria: * significant colorectal symptom(s) as determined by medical history or by participant self-report * participant-reported symptoms and/or clinical or laboratory diagnosis of active rectal infection requiring treatment per current centers for disease control (cdc) guidelines * a positive test for herpes simplex virus -2 (hsv-2) (individuals with active lesions only) * co-enrollment in any other hiv interventional research study (excluding behavioral only interventions) or prior enrollment in the active arm of a hiv vaccine trial. * positive hepatitis b surface antigen (hbsag) test * interleukin therapy; medications with significant nephrotoxic potential, including but not limited to amphotericin b, aminoglycosides, cidofovir, foscarnet and systemic chemotherapy; medications that may inhibit or compete for elimination via active renal tubular secretion (including but not limited to probenecid); systemic immunomodulatory medications * participants with a history of having a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract or drug absorption * medications that prolong clotting time * any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements.
late reperfusion with percutaneous coronary intervention in patients with st-segment elevation myocardial infarction

Conditions: Ischemic Heart Disease; ST-segment Elevation Myocardial Infarction

Summary: although recommended therapy for patients with st-segment elevation myocardial infarction is primary pci, it remains unestablished whether patients with a symptom duration of more 12 hours benefit from acute revascularisation. this study aims to investigate whether acute intervention is superior to subacute intervention in these patients.

the recommended therapy for patients with st-segment elevation myocardial infarction (stemi) is to restore normal coronary blood flow with timely reperfusion by percutaneous coronary intervention (pci), and thereby minimize the extent of cell death and preserving cardiac function. the duration of ischemia and timely pci are major determinants for the size of the myocardial infarction and prognosis. thus, acute pci should be performed within 12 hours after symptom onset. the effect of pci and timing of pci are, however, much more uncertain for late presenters who contact the health service \> 12 hours from symptom. thus, it is still unknown whether late presenters should be treated with acute pci or medical treatment with delayed pci (24-72 h after first medical contact). the study investigates the effect on final salvage index evaluated by magnetic resonance imaging of acute pci of late presenters. the overall objective of the study is to investigate whether late presenters may benefit from acute pci, and thus whether to extend the currently recommended time limit of 12 hours for acute pci in patients with stemi.

Eligibility criteria:
inclusion criteria: * inclusion criteria: * patients more than 18 years of age. * stemi \> 12 hours and \< 36 hours. * clinical stable, i.e. no on going angina, hemodynamically stable (systolic bp \> 90) and killip class \< 3. exclusion criteria: * clinical instability which requires an acute invasive strategy. * left main occlusion or multivessel disease which requires cabg. * previous q-wave infarction in the current infarct related artery. * left bundle branch block (lbbb). * severe renal insufficiency. * pacemaker * chronic atrial fibrillation. * previous coronary artery bypass surgery (cabg). * pregnancy. * other severe illness with life expectancy less than 1 year

Keywords: myocardial infarction late presenters primary percutaneous coronary intervention reperfusion angioplasty duration of ischemia cardiovascular magnetic resonance imaging