Kornimate/medical-research-clean huggingface dataset:
efficacy of pjs-539 for adult patients with covid-19.

Conditions: Covid19; COVID-19 Pneumonia

Summary: the pjs-539 is a multicentre, phase 2, randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of pjs-539 in the viral load of patients with severe acute respiratory syndrome coronavirus 2 (sars-cov-2).

covid-19, a disease caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) became a pandemic in march 2020. clinically, the coronavirus disease 2019 (covid-19) ranges from asymptomatic disease in some to severe forms. however, until now, only the use of corticosteroids in selected patients has been shown to improve clinical outcomes in patients with covid-19. pjs-539 has been demonstrated to inhibit viral uptake and replication of sars-cov-2. the objective of this phase ii trial is to assess the effect of pjs-539 in the viral load of patients with mild to moderate covid-19 symptoms.

Eligibility criteria:
inclusion criteria: 1. adult patients (age ≥ 18 years); 2. covid-19 diagnosis confirmed by: 1. detection of sars-cov-2 by reverse transcription polymerase chain reaction (rt-pcr), or 2. rapid genetic or antigen tests validated by brazilian national health surveillance agency (anvisa); 3. mild or moderate symptoms without indication for hospitalization; 4. symptoms started seven days ago or less; 5. be able to access the study's online questionnaire. exclusion criteria: 1. pregnant or lactating women; 2. known allergy or hypersensitivity to the study drug; 3. patients at high risk of bleeding, defined by: 1. previous intracranial hemorrhage, 2. ischemic stroke in the last 3 months, 3. anatomical vascular alteration of the central nervous system known, such as aneurysms or arteriovenous malformations, 4. malignant neoplasm of the central nervous system known, 5. metastatic solid neoplasia, 6. significant closed head or facial trauma in the last 3 months (defined as any trauma that required medical evaluation or hospitalization), 7. known intracranial abnormalities not listed as absolute contraindications (e.g., benign intracranial tumor), 8. bleeding in the last 2 to 4 weeks (excluding menstrual bleeding), 9. surgical procedure in the last 3 weeks, 10. current use of full-dose anticoagulants (warfarin, enoxaparin or new anticoagulants) or dual antiplatelet therapy, 11. thrombocytopenia (\ 1.3; 4. renal failure, defined as glomerular filtration rate (gfr) estimated by the formulas modification of diet in renal disease (mdrd) or chronic kidney disease epidemiology collaboration (ckd-epi) \<30 ml/min/1.73m2; 5. previous participation in the study; 6. history of liver disease (cirrhosis) reported by the patient or in medical records, presence of esophageal varices or presence of ascites; 7. decompensated heart failure, defined by the presence of dyspnea attributed to cardiac cause, edema of the lower limbs, crackles on pulmonary auscultation or pathological jugular turgency. 8. participation in other clinical trials with antivirals in covid-19

Keywords: covid-19 antiviral
cold water exposure's effects on physical and mental health

Conditions: Cold Exposure

Summary: an interest in cold-water immersion (cwi) to elicit diverse physiological effects has been prevalent for centuries. cwi typically consists of bodily exposure to water at temperatures ranging from 5-10º c for various durations. cwi has profound cultural significance in different areas of the world, such as in scandinavian countries, and has emerged as a popular modality for its purported health-promoting effects. individuals on social media have repeatedly advocated for cwi as a method to improve muscular recovery, enhance sleep, and increase immune and cognitive function. because of this, companies that specialize in cold tub production have become popularized; however, individuals who are seeking a more cost-effective option are drawn toward cold showers for their preferred method of cold exposure. despite the scarcity of rigorous research investigating the difference in effects of cold tub versus cold shower cwi, individuals on social media promoting cwi via a shower continue to praise its comparable benefits to that of a tub. therefore, investigations of chronic cwi (utilizing both a cold tub and a cold shower) is vital. thus, the purpose of the proposed study is to explore the varying effects of chronic cwi on neural and cognitive function using a cold tub and a cold shower. further, the study aims to investigate performance measures and immune measures to create a comprehensive understanding of cwi's implications on human physiology over time. the investigators hypothesize measures relating to mental performance and health will improve after 4-weeks of cwi, and there will be no difference between tub and shower immersion groups.


Eligibility criteria:
inclusion criteria: * healthy volunteers * aged 18-45 exclusion criteria: * current holds a cold water exposure routine (≥3 sessions in the last month, consisting of ≥4 minutes per immersion) * currently pregnant of planning to become pregnant * chronic use of anti-inflammatory medication * prior history of chronic disease conditions: cardiovascular disease, diabetes, cancer, raynaud's disease, or severe/untreated anxiety or depression

Keywords: cold water immersion cold tub cold shower
neoadjuvant chemotherapy with pyrotinib, epirubicin and cyclophosphamide followed by taxanes and trastuzumab for her-2+ breast cancer

Conditions: Breast Cancer

Summary: this is a prospective, open label, parallel controlled study to evaluate the efficacy and safety of neoadjuvant pyrotinib in her2+ breast cancer patients


Eligibility criteria:
inclusion criteria: 1. female breast cancer patients at the age of \>= 18 years and \<= 65 years who received first treatment； 2. pathologically confirmed her2-positive invasive breast cancer（which is defined as the immunohistochemistry score of \> 10% immunoreactive cells being 3+ or in situ hybridization results showing her2 gene amplification），regardless of hormone receptor status (er and pr)； 3. according to the 2019 csco bc guidelines: when her-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm； 4. the eastern tumor collaborative group (ecog) has a physical status score of ≤1； 5. the functional level of the main organs must meet the following requirements ： 1) blood routine test: hemoglobin (hb) ≥ 90g/l;neutrophils (anc) ≥ 1.5 × 10\^9/l; platelet count (plt) ≥ 90 × 10\^9/l; 2) blood biochemistry: total bilirubin (tbil) ≤ 1.5 upper limit of normal value (uln); alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 1.5 × uln; alkaline phosphatase ≤ 2.5 × uln; urea nitrogen (bun) and creatinine (cr) ≤ 1.5 × uln; 3) heart color ultrasound: left ventricular ejection fraction (lvef) ≥ 55%; 6. women of childbearing age, tested negative for serum pregnancy test 7 days before randomization，and willing to use appropriate methods during the trial and within 8 weeks after the last administration of the test drug; 7. a volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up. exclusion criteria: 1. known history of hypersensitivity to pyrotinib or any of it components; 2. patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured); 3. patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered; 4. subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption; 5. patients with severe heart disease or discomfort who cannot be treated; 6. the patient suffers from mental illness or psychotropic substance abuse and cannot cooperate; 7. pregnant or lactating women; 8. less than 4 weeks from the last clinical trial; 9. patients participating in other clinical trials at the same time 10. the researchers think inappropriate.
pegfilgrastim administered on the same day as chemotherapy in non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: the purpose of this study is to provide data on the safety and efficacy of pegfilgrastim when administered on the same day versus the next day of chemotherapy, as measured by the duration of grade 4 neutropenia.

this was a multicenter, double-blind, randomized, phase 2 study of pegfilgrastim given either the same day as or the day after a chemotherapy regimen consisting of cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (r-chop). chemotherapy was administered every 21 days for up to 6 cycles in subjects with aggressive non-hodgkin's lymphoma (nhl; mantle cell or diffuse large b-cell lymphoma). subjects were administered r-chop on day 1 of each cycle. all subjects were randomized to 1 of 2 treatment arms: arm a subjects were administered pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion); arm b subjects were administered pegfilgrastim 6 mg on day 2 of each cycle (at least 24 hours after chemotherapy completion). all subjects were administered placebo on the day they did not receive pegfilgrastim. a total of 77 subjects were enrolled at 24 centers across the us. protocol treatment duration for subjects was up to 18 weeks (6 three-week cycles).

Eligibility criteria:
inclusion criteria: - histologically proven mantle cell lymphoma or histologically proven diffuse large b-cell non-hodgkin's lymphoma (nhl) according to the real classification - measurable and/or evaluable disease - previously untreated patients exclusion criteria: - burkitt's or b-lymphoblastic lymphoma - central nervous system (cns) involvement - active infection requiring treatment with systemic anti-infectives within 72 hours of chemotherapy - prior malignancy within the last 5 years - t-cell lymphoma or history of indolent lymphoma - prior bone marrow or stem cell transplantation - known sensitivity to e. coli derived drug products

Keywords: oncology nhl mantle cell diffuse large b-cell chemotherapy rchop neulasta® neutropenia pegfilgrastim amgen
quantification of prosthesis penetration with conebeam in otosclerosis

Conditions: Otosclerosis

Summary: sensorineural complications of stapes surgery are rare but potentially serious. imaging is usually performed to identify an underlying cause, such as excessive intravestibular penetration of the prosthesis or pneumolabyrinth suggesting perilymphatic fistula. unfortunately, there is very little data in an unselected series of uneventful patients. the aim of this study is to analyze the depth of prosthesis penetration within the vestibule and the rate of pneumolabyrinth the day or the day after the procedure by performing a cone beam ct (cbct) of the temporal bone in a cohort of unselected patients, and to correlate imaging findings to clinical outcome. this prospective monocentric study is conducted in a tertiary referral medical center. a cbct is performed in 80 consecutive patients having undergone stapes surgery for otosclerosis, the day or the day after the procedure. penetration length and location of the prosthesis within the vestibule, as well as presence or absence of a pneumolabyrinth are recorded, and compared to clinical data (vertigo, nystagmus, hearing measurement).


Eligibility criteria:
inclusion criteria: * age \>= 18 years old * patients undergoing stapes surgery for otosclerosis exclusion criteria: * patient's refusal to participate in the study * patient under legal protection * no medical insurance coverage * pregnant or breast feeding patient

Keywords: stapes surgery sensorineural complications inner ear imaging cone beam ct
study of bathing with chlorhexidine impregnated cloths on nosocomial infections in the pediatric intensive care unit

Conditions: Nosocomial Infections

Summary: the investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the pediatric intensive care unit (picu).


Eligibility criteria:
inclusion criteria: * patients in pediatric intensive care unit exclusion criteria: * patients with a history of an allergic reaction to chlorhexidine * patients less than 2 months of age * patients with severe skin disease or burn * patients with an indwelling epidural catheter or lumbar drain

Keywords: intensive care unit healthcare associated infections (hai) pediatric
limited long term survival in patients after in-hospital intestinal failure requiring total parenteral nutrition

Conditions: Nutrition Disorders

Summary: the purpose of this study is to determine what the long term survival is after in hospital use of total parenteral nutrition due to intestinal failure. earlier studies only followed patients for a maximum of 6 months or included only very specific patients. we were interested in all patients in our hospital and followed them for up to 2 years.

extensive description is not desired

Eligibility criteria:
inclusion criteria: * all consecutive patients on tpn exclusion criteria: * patients from the pediatric and haematological departments

Keywords: mortality long term follow-up parenteral nutrition, total
factors affect outcomes in cardiovascular surgery

Conditions: Coronary Artery Disease; Valvular Diseases; Vascular Diseases

Summary: identify factors that contribute to perioperative morbidity and mortality in patients undergoing cardiac surgery that involves cardiopulmonary bypass. identify factors that affect perioperative morbidity and mortality in patients undergoing cardiac surgery.

identify factors that affect perioperative morbidity and mortality in patients undergoing cardiac surgery. here are some examples, but may not limited the following factors: 1. demographic data 2. perioperative medications 3. comorbidity

Eligibility criteria:
inclusion criteria: patients greater than or equal to 18 years old that underwent cardiovascular surgery at uc davis medical center from 01/01/2001 to 07/15/2013. patients will only be included that underwent cardiovascular surgeries with or without cardiopulmonary bypass. exclusion criteria: patients that did not undergo cardiovascular surgeries and age\< 18 years old will be excluded from the study.
the presence of humanoid robot with older adults at homes

Conditions: Loneliness; Cognitive Impairment; Depression; Self Efficacy; Sense of Coherence

Summary: background older adults experience significant physical, cognitive and environmental losses in their later life. self-supported 'aging-in-place' has benefits for mental health and the quality of life for older people. in the field of gerontological nursing, person-centered holistic care highlights the importance of enabling older people and their significant others (such as older spouse or other family caregivers) to establish healthful relationships so to improve older adults' physical, psychological, mental and social wellbeing. however, globally and also most recommended by hong kong government, home-based care services for older adults have not been fully developed. research on the use of robots supporting older adults is given increasing attention in the globe, but most of them were focused on aiding older adults who are living with dementia or residing in nursing homes. more robotic research needs to be conducted at their own homes in the community and support older people in having an independent lifestyle. study aim this study aims to investigate the feasibility and acceptability of home-based physical robot humane by community-dwelling chinese older adults and soon-to-be-aged adults and their family caregivers. study design and method this study will employ a two-arm pilot randomized control trial with qualitative interviews. people aged 50 or above who are receiving home care from family members will be recruited to this study. purposive sampling will be adopted in recruitment. the robot humane will be used by the intervention group for a 6-week trial. loneliness, cognitive function, emotional status, self-efficacy, mutuality and sense of coherence will be measured at baseline (day-1) and immediately post-intervention (week-6) to examine preliminary effect of using robot at home. data analysis spss statistics 26 will be adopted for all analyses. descriptive statistics, generalized estimating equations (gee) models and a deductive content analysis approach will be used in data analysis. significances of the study the study will add evidences in the field that social robot may be able to address some of the unmet needs of older people living at their own homes in the community, particularly relating to loneliness, enhancing the development of home-based care services for older adults.


Eligibility criteria:
inclusion criteria: * ethnic chinese aged 50 years and above; * need home-based care from family caregiver, including spouses; * live with at least one family caregiver at his/her own home (not in residential care homes) in hong kong; * are able to communicate in cantonese. exclusion criteria: * with acute mental disorders or disabling diseases that may limit the practice of engaging with robot; and * have limited access to electricity and this makes them hard to use technology at home.
development of algorithms for a hypoglycemic prevention alarm: closed loop study

Conditions: Type 1 Diabetes Mellitus

Summary: this research study, development of algorithms for a hypoglycemic prevention alarm, is being conducted at stanford university medical center and the university of colorado barbara davis center. it is paid for by the juvenile diabetes research foundation. the purpose of doing this research study is to understand the best way to stop an insulin infusion pump from delivering insulin to prevent a subject from having hypoglycemia. nocturnal hypoglycemia is a common problem with type 1 diabetes. this is a pilot study to evaluate the safety of a system consisting of an insulin pump and continuous glucose monitor communicating wirelessly with a bedside computer running an algorithm that temporarily suspends insulin delivery when hypoglycemia is predicted in a home setting.

after the run-in phase, there is a 21-night trial in which each night is randomly assigned 2:1 to have either the predictive low-glucose suspend (plgs) system active (intervention night) or inactive (control night). three predictive algorithm versions were studied sequentially during the study.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older, 2. type 1 diabetes for at least 1 year 3. current user of the minimed paradigm real-time revel system and sof-sensor glucose sensor 4. hemoglobin a1c level of \< 8.0%, 5. home computer with access to the internet, 6. at least one cgmglucose value \< 70 mg/dl during the most recent 15 nights of cgm glucose data. 7. not pregnant or planning to become pregnant exclusion criteria: the exclusion criteria for this study is the following: 1. the presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol 2. the presence of any of the following diseases: * asthma if treated with systemic or inhaled corticosteroids in the last 6 months * cystic fibrosis * angina (recurrent heart pain) * past heart attack or coronary artery (heart vessel) disease * past stroke or impairment of blood flow to the brain * other major illness that in the judgment of the investigator might interfere with the completion of the protocol adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment 3. inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian) 4. current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study 5. severe hypoglycemic event, as described as a seizure, loss of consciousness, severe neurological impairment, or neurological impairment suggestive of hypoglycemia and requiring an emergency department visit or hospitalization within 18 months of enrollment.
safety evaluation of functional electrical stimulation (fes) cycling in intensive care unit patients

Conditions: Muscle Weakness

Summary: intensive care unit acquired muscle weakness (icuaw), is a common disease which influence rehabilitation, extend mechanical ventilation and length of stay in intensive care unit, and affect quality of life at hospital discharge. to prevent icuaw, different strategies of early mobilization are recommended. but all cannot be applied in all icu patients. some of them benefit from heavy therapies like circulatory assistance or renal replacement therapy for example, that limit mobilization. cycloergometer is a tool that allows continuous passive mobilization in bedridden and even unconscious patients. neuromuscular electrical stimulation (nmes) is an alternative that helps preserve muscle mass and limit muscle atrophy. early bedside cycle exercise coupled with nmes is an interesting new approach where application of an electrical stimulation along specific motor nerves on each lower limb, generates muscles contractions and pedaling on cycloergometer. the aim of this study is to evaluate safety and feasibility of this coupled technique called functional electrical stimulation (fes) cycling, in icu patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * deeply sedated (riker 1-2) patients, admitted in intensive care unit b of st-etienne hospital * without curare since 12 hours * normothermic or with a controlled fever (central temperature between 36 and 38°c) * without haemodynamic instability (mean arterial pressure \> 65mmhg and \ 90mmhg and \< 200mmhg, norepinephrine \< 4mg/h) * without respiratory instability (respiratory rate \ 90%, inspired oxygen fraction \ 250, peep \< 10cmh2o, with invasive mechanical ventilation) * without neurological instability (diastolic velocities in mean cerebral artery \> 30cm/s, mean velocities \> 50cm/s, pulsatility index \ 15mmhg) * patient whose family has given informed and written consent to the patient's participation in the study exclusion criteria: * pregnant woman, * patients with peripheral nerve damage prior to or at the time of measurement * curarized patients (non-efficacy of neurostimulation) * presence of a catheter in the stimulation zone (femoral artery or vein) * patients with lower limb, pelvic or spine fracture * patients with continuous renal replacement therapy * patients with circulatory assistance * patients with wounds in electrodes placement area * morbidly obesity with ideal body weight \> 40kg/m2 * patients with pacemaker * lower limb deep vein thrombosis without treatment

Keywords: intensive care unit acquired muscle weakness cycloergometer neuromuscular electrical stimulation fes cycling