Kornimate/medical-research-clean huggingface dataset:
muscle-related side effects of statins: functional impact, mechanisms, and potential relief with vitamin d supplementation

Conditions: HMG COA Reductase Inhibitor Adverse Reaction

Summary: this proposal will explore muscle function (strength and endurance) in men and women suffering from statin-induced muscle symptoms. the mechanisms responsible for these muscle symptoms will be explored. also, the investigators will assess the potential usefulness of vitamin d supplementation in a randomized control trial.

statins are a class of drugs that are widely prescribed to lower blood cholesterol levels. although they have few side effects, many patients report muscle pain, cramps, and weakness when using these drugs. we know very little on the real impact of these muscle symptoms on patient quality of life, especially in relation to muscle strength and endurance. patients under statin therapy will stop medication for 2 months. results from blood sample, muscle function and muscle biopsy (in some participants) will be compared with baseline. participants will then take vitamin d supplementation or placebo for one month. thereafter, statin will be reintroduced for two months while continuing vitamin d or placebo supplementation. at the end of that time, measures from blood sample, muscle function and muscle biopsy will be compared with other visits.

Eligibility criteria:
inclusion criteria: * statin therapy * healthy and sedentary or moderately physical active exclusion criteria: * current treatment with other lipid-lowering drugs * natural medicine affecting lipid metabolism * ck levels above the normal range * clinical vitamin d deficiency * impaired liver or kidney function * untreated hypo- or hyperthyroidism * treatment with other medications known to increase risk of myopathy * existing infection requiring antibiotic therapy * consumption of greater than 60 ml of grapefruit juice per day * inherited muscle disorders or myopathy * polymyositis or inflammatory myopathy * use of corticosteroids * comorbidities resulting in muscle or bone pain * history of elevated ck * unexplained cramps * known sickle cell trait * cancer within the 5 years prior to study entry * diabetes * stroke, coronary artery or peripheral vascular disease * physical disability or previous injury interfering with exercise testing * pregnant or breastfeeding * depression (in last 3 years) or treatment with antidepressants * use of anti-psychotic drugs * alcohol abuse

Keywords: statins side effects muscle vitamin d biopsy strength fatigue
efficacy and safety of rtms for cognitive rehabilitation in moyamoya disease

Conditions: Moyamoya Disease

Summary: the purpose of this study is to evaluate the safety and effectiveness of transcranial magnetic stimulation (tms) therapy in moyamoya patients who received surgical revascularization.

primary outcome measures: tms stimulation applied to the left dlpfc has a quantifiable effect on cognition \[ time frame: neuropsychological assessments: baseline（7days after sta-mca bypass surgery）; 2 months after tms treatment changes in one or more assessed cognitive domains at baseline will be measured by comparing the scores for the different neuropsychological tests. secondary outcome measures: change in structural grey and white matter in the brain at baseline compared to after tms stimulation \[ time frame: mri: baseline and two months after tms stimulation \] mri analysis will measure any changes in cortical thickness (mm) or other structural changes in the brain after tms or sham-tms stimulation change in executive functioning measured as resting-state functional mri (fmri) sequence \[ time frame: mri: baseline and two months after tms stimulation \] fmri analysis will measure any changes in amplitude of low frequency fluctuation(alff) and other functional changes after tms stimulation compared to baseline.

Eligibility criteria:
inclusion criteria: 1. right-handed chinese population aged 18-80 years; 2. no evidence of infarct in the cerebral cortex, basal ganglia, brainstem, or cerebellum, but small patches of hyper intense signal neither larger than the arbitrary cut off of 8 mm in maximum dimension on t2-weighted mr images no cystic in the cerebral subcortical white matter could be involved; 3. no evidence of intracerebral hemorrhage; 4. diagnosis through digital subtraction angiography; 5. physically capable of cognitive evaluation; 6. absence of significant psychiatric disorders or neurological diseases; 7. no evidence of perioperative epilepsy. exclusion criteria: 1. significant neurological diseases or psychiatric disorders that could affect cognition 2. other cerebrovascular diseases (such as atherosclerosis or vasculitides) likely to cause focal cerebral ischemia 3. concomitant cerebrovascular diseases (such as aneurysms or arteriovenous malformation) that need surgical intervention 4. severe systemic diseases pregnant or perinatal stage women 5. any diseases likely to death within 2 years 6. taking drugs such as benzodiazepine clonazepam 7. allergy to iodine or radiographic contrast media 8. concurrent participation in any other experimental treatment trial

Keywords: transcranial magnetic stimulation cognitive impairment
multicenter registry study of cerebral venous thrombosis in china (retain-ch)

Conditions: Cerebral Vein Thrombosis; Cerebral Venous Sinus Thrombosis

Summary: this study will investigate the epidemiology, risk factors, diagnostics, treatment, and the long-term prognosis of cerebral venous thrombosis in china.

the epidemiology, risk factors, diagnosis and treatment of cerebral venous thrombosis (cvt) in china are still unclear. a retrospective hospital-based study will be conducted at fifty different hospitals across 31 provinces in china. this study will use icd-10 to search patients diagnosed with cvt between january 1, 2018 and june 15, 2022 across 31 provinces and municipalities of 104 hospitals in china. risk factors, clinical and radiological findings, treatment and short-term outcomes will be recorded from the hospital record system. finally, a prospective follow-up will be conducted for all of the patients enrolled above. by combining data collected from retrospective hospital records with the new follow-up, it will be possible to better understand the epidemiology, risk factors, diagnosis, treatment and the long-term prognosis of cvt in china.

Eligibility criteria:
inclusion criteria: * cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis diagnosed by digital subtraction angiography (dsa), magnetic resonance venography (mrv), computed tomography venography (ctv) or high-resolution magnetic resonance imaging (hr-mri). exclusion criteria: * none of the patient, trustee or immediate family members signed the informed consent.

Keywords: cerebral venous sinus thrombosis
vaginal estrogens comparative trial on pelvic organ prolapse patients

Conditions: Vaginitis Atropic; Pelvic Organ Prolapse; Endometrial Hyperplasia

Summary: to evaluate the difference of three vaginal estrogens creams comparative with placebo on improvement of hormonal cytology, local and systemic climacteric complaints, as well as its endometrial security.


Eligibility criteria:
inclusion criteria: * post menopause women * normal oncotic cytology and mammogram * any grade of pelvic organ prolapse with surgery indication and ultrasound with endometrium measure less than 5 mm exclusion criteria: * vaginal bleeding * hormonal replacement on the past three months * renal or hepatic desease * porfiria * past venous thromboembolism; ulcerated prolapse
study to evaluate the mass balance and biotransformation of [14c]-fluzoparib in chinese patients with solid tumor

Conditions: Solid Tumor

Summary: study to evaluate the mass balance and biotransformation of single dose \[14c\]-fzpl in chinese patients with solid tumor


Eligibility criteria:
inclusion criteria: 1. subjects diagnosed with advanced solid malignancies who are refractory or intolerant to standard therapy or considered to be benefit from the treatment of fluzoparib. 2. ecog performance status of 0 to 1. 3. life expectancy of more than 3 months. 4. signing the informed consent forms. 5. adequate bone marrow, liver and renal function. 6. be able to communicate well with the researcher and be able to complete the trial in accordance with the program. exclusion criteria: 1. subjects who take any drugs that strongly inhibit or induce the cyp450 enzyme 14 days prior to study drug administration； 2. those who have history of alcohol abuse (it was defined as that the daily alcohol consumption was higher than the following criteria: the weekly alcohol consumption was higher than 14 units of alcohol (1 unit= 360 ml beers/45 ml liquor containing 40% alcohol/150ml grape wine) 6 months prior to screening period, or the alcohol breath test results ≥20 mg/dl during screening period； 3. subjects who smoked daily \>5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study. 4. subjects who have history of drug abuse or taking soft drug (i.e., marihuana) 3 months prior to screening period or taking hard drugs (i.e., cocaine, amphetamines, benzodiazepine, etc.); or the results of urine test in drugs were positive. 5. subjects who were used to drink grapefruit juice or overconsumption of tea, coffee, and the drink with caffeine; and cannot give up them during test. 6. subjects who need long-term exposure to radiation, or who have been exposed to pet-ct or ect within 3 months prior to study drug administration or who have participated in the labeling test of radiopharmaceuticals. 7. subjects who have fertility planning within the range of starting trial - 1 year after finishing trial. 8. subjects who have excessive bleeding or blood donation (400ml) 3 months prior to screening period, or planned to donate blood 1 month after finishing this trial. 9. subjects who have habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease. 10. subjects must not have had prior treatment with parp inhibitors. 11. subjects who cannot complete this study because of other reasons, or any factors judged by investigator that the participants cannot meet.

Keywords: solid tumor 14c-fluzoparib
study to evaluate safety, tolerability and explorative efficacy of dm-101px in birch pollen allergic participants

Conditions: Birch Pollen Allergy

Summary: randomized, double-blind placebo-controlled phase i trial with the primary aim to investigate safety and tolerability of three ascending dosing schemes of dm-101-px in birch pollen allergic adults. as an explorative objective, the trial will also investigate the effect of dm-101px on the allergic symptoms following birch pollen allergen exposure in a chamber. expanded access to the study treatment is not available.

the study will be carried out in a single study site located in canada

Eligibility criteria:
inclusion criteria: * either sex or any race, aged 18 to 65 years * good general health * a documented clinical history of moderate to severe birch pollen induced allergic rhinitis or rhinoconjunctivitis with symptoms that interfere with daily activities or sleep and remain bothersome despite the use of relevant symptomatic medication, and have been present over at least 2 previous birch pollen seasons * birch pollen specific ige ≥ 0.7 ku/l * positive spt to birch pollen allergen, with wheal diameter ≥ 3 mm * body weight ≥ 50 kg and body mass index within the range of 18-35 kg/m2 exclusion criteria: * history or findings on physical examination of any significant disease or disorder which, in the opinion of the investigator, could put the subject at risk because of participation in the trial, influence the results of the trial or subject's ability to participate in the trial * current diagnosis of persistent asthma, or moderate to severe asthma requiring gina step 2 or higher treatment, or asthma partially controlled or uncontrolled according to gina classification in the 6 months before screening * significant rhinitis, sinusitis, significant and/or severe allergies not associated with the birch pollen season * history of asthma deterioration that resulted in emergency treatment or hospitalization in the past 12 months before screening, or a life-threatening asthma attack at any time in the past * a forced expiratory volume in one second (fev1) ≤ 75% of predicted value * history of severe drug allergy, severe angioedema, or systemic allergic reaction of grade 3 or grater, according to world allergy organization (wao) scale, due to any cause
host rna profiles to detect infections in young infants

Conditions: Bacterial Infections; Urinary Tract Infections; Sepsis; Fever; Viral Infection; Infant, Newborn, Disease; Bacteremia; Meningitis

Summary: this study seeks to identify and test host rna expression profiles as markers for infections in young infants. preliminary studies have shown high sensitivity and specificity for the discrimination of bacterial from non-bacterial infections in children, but the method has only been investigated in a limited number of young infants. the study aims to include 65 young infants with serious bacterial infections. the samples will be analysed by rna sequencing. new diagnostic tools may help reduce unnecessary antibiotic treatment, antibiotic resistance, side-effects, hospitalisation and invasive procedures.

background: infections in young infants is a challenge as 1) it is often not possible to distinguish serious bacterial infection (sbi) from viral infection by clinical appearance alone, 2) a causative organism is often not identified and 3) due to relatively low sensitivity and specificity of current biomarkers. the consequence is overtreatment with antibiotics being prescribed to as many as 50% of febrile young infants presenting to emergency departments. however, the majority of these children does not have a bacterial infection. host rna expression profiling has shown high sensitivity and specificity for discriminating bacterial from non-bacterial infections in preliminary studies of febrile young infants. methods: a prospective multicentre observational study including young infants admitted and evaluated due to suspected infection at the 4 paediatric acute care units in the capital region of denmark (rigshospitalet, hvidovre hospital, herlev hospital, nordsjællands hospital - hillerød). whole blood will be collected in paxgene blood rna tubes and analysed by rna sequencing at the centre for genomic medicine, rigshospitalet. host rna expression profiles will be identified in a discovery cohort and the diagnostic performance will be tested in a validation cohort. a control group of healthy and afebrile young infants will be included. time frames: patient recruiting: may 15th 2020 to february 28th 2022. sample analysis (rna sequencing): march 1st 2022 to august 31st 2022. perspectives: new molecular-based diagnostic tools complementary to conventional methods may optimise infection management in young infants by improving early diagnostics and allowing early modification of antibiotic treatment. this will reduce antibiotic resistance, side effects, unnecessary hospitalisation and invasive procedures.

Eligibility criteria:
inclusion criteria: 1. age 0-3 months 2. admitted from home 3. suspected of infection 4. having routine blood sampling done 5. gestational age or corrected gestational age greater than or equal to 37+0 6. informed consent exclusion criteria: 1. not possible to draw blood tests 2. withdrawal of consent 3. sampling \>48 hours after admission
hyperventilation in patients with traumatic brain injury

Conditions: Head Injury Trauma; Hyperventilation

Summary: elevated intracranial pressure is a dangerous and potentially fatal complication after traumatic brain injury. hyperventilation is a medical intervention to reduce elevated intracranial pressure by inducing cerebral vasoconstriction, which might be associated to cerebral ischemia and hypoxia. the main hypothesis is that a moderate degree of hyperventilation is sufficient to reduce the intracranial pressure without inducing cerebral ischemia.

in patients with severe traumatic brain injury (tbi), and with intracranial pressure-monitoring, brain tissue oxygen tension and/or microdialysis probes hyperventilation-tests are performed in the acute phase after trauma. data are collected and tccd measurements are performed at baseline, at the beginning of moderate hyperventilation, after prolonged moderate hyperventilation (for 50 minutes) and after return to baseline. the present study aims to quantify potential adverse effects of moderate short-term hyperventilation during the acute phase of the severe tbi on cerebral hemodynamics, oxygenation, and metabolism.

Eligibility criteria:
inclusion criteria: * nonpenetrating traumatic brain injury * glasgow coma scale \<9 at presentation * intracranial pressure monitoring * brain tissue oxygen tension monitoring and/or microdialysis monitoring * invasive mechanical ventilation with fio2 \<60% and peep \<15 mbar exclusion criteria: * decompressive craniectomy * pregnancy * pre-existing neurological disease * previous traumatic brain injury * acute cardiovascular disease * severe respiratory failure * acute on chronic liver disease * sepsis * failure to obtain satisfactory bilateral tccd signals * persisting hypovolemia or hemodynamic instability

Keywords: intracranial pressure cerebral metabolism cerebral oxygenation
opera - incorporating robotic surgery in both mastectomy and diep flap reconstruction

Conditions: Breast Cancer; Mastectomy; Lymphedema

Summary: current breast cancer surgery is achieving minimally invasive approach to reduce incision while providing better surgical vision and freedom in mastectomy. breast reconstruction with free deep inferior epigastric artery perforator (diep) flap was considered the gold standard, however, the donor site morbidity remains an endless concern. here we applied robotic-assisted surgery in both mastectomy and free diep flap harvest, so-called oncoplastic entirely robot-assisted approach (opera). a retrospective chart review identified 14 patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free diep flap harvest for breast reconstruction. the patient demographics and mastectomy and flap characteristics were reviewed.


Eligibility criteria:
inclusion criteria: * patients with asa (american society of anesthesiologist) classification 1-2 * breast skin should be free from cancer involvement, with adequate tumor to skin distance, and the largest preoperative tumor size no more than 5 cm * the lesion should be located in any of the 4 quadrants away from the nipple, at least 1 cm distance between the lesion and the nipple exclusion criteria: * patients with previous pelvis surgeries (except c-section)
glofitamab in chinese patients with r/r dlbcl

Conditions: DLBCL - Diffuse Large B Cell Lymphoma

Summary: this study will evaluate the safety and efficacy of glofitamab as a single agent in chinese patients with relapsed or refractory (r/r) diffuse large b-cell lymphoma (dlbcl) who have failed two or more lines of systemic therapy.


Eligibility criteria:
inclusion criteria: 1. histologically-confirmed dlbcl 2. participants must have relapsed or failed to respond to at least two lines of prior systemic therapy 3. participants must have measurable disease exclusion criteria: 1. pregnancy or breastfeeding 2. patient with known active infection, or reactivation of a latent infection 3. patient with active autoimmune disease or immune deficiency 4. severe organ failure：lvef\<40%；dlco\<40%；egfr\<30ml/min；bilirubin≥3uln 5. patients who are dependent on the sponsor, the investigator or the trial site
the effect of oxytocin nasal spray on preventing postoperative delirium in elderly patients undergoing orthopedic surgery

Conditions: Cervical Spinal Stenosis; Thoracic Spinal Stenosis; Lumbar Spinal Stenosis; Rotator Cuff Injury; Femoral Head Necrosis; Spinal Trauma; Knee Joint Injury

Summary: postoperative delirium is a delirium that occurs within 7 days after surgery or before hospital discharge. it has been shown that combined pod can increase the incidence of postoperative pulmonary infections, deep vein thrombosis and decubitus ulcers, and increase the incidence of disability and mortality. the incidence of postoperative delirium in geriatric orthopedics is high. investigators conduct a prospective clinical study on geriatric orthopedic surgery patients to investigate the effect of oxytocin nasal spray on the prevention of postoperative delirium in geriatric orthopedic surgery. cases were included according to the inclusion and exclusion criteria, and induction, maintenance and resuscitation were performed according to the standard protocol for general anesthesia. before the end of surgery, the investigators administered oxytocin nasal spray (oxytocin) that was 3 sprays in each nostril (4 iu each) for a total of 24 iu. beginning 1 day postoperatively, administer 24 iu of oxytocin nasal spray 2 times/day in the morning and in the evening. until 7 days after surgery or discharge. the sample size are 77 cases in phase i and 143 cases in phase 2, total 220 cases.


Eligibility criteria:
elderly patients undergoing orthopedic surgery under general anesthesia inclusion criteria: 1. age ≥ 65 years; 2. patients who were to undergo elective orthopedic surgery under general anesthesia with tracheal intubation; 3. asa class i-iii; 4. estimated duration of surgery ≥ 1 hour; (5) the patient himself/herself or his/her legal representative; 5. informed consent from the patient or legal representative; 6. proficiency in the use of chinese language for communication. exclusion criteria: 1. nasal cavity occupation, patients with fillers in the nose 2. oxytocin allergy; 3. patients with previous psychiatric and neurological disorders, such as depression, severe central nervous system depression, parkinson's disease, basal ganglia disease. goldson's disease, basal ganglia lesions, schizophrenia, epilepsy, alzheimer's disease, myasthenia gravis, and so on; 4. pregnant and lactating women 5. patients with severe hepatic insufficiency (child-pugh class c); 6. patients with severe renal insufficiency (dialysis is required before surgery) 7. severe heart failure (mets\<4); 8. preoperative inability to communicate (coma or dementia); 9. severe preoperative blindness, deafness, or inability to understand mandarin to complete preoperative delirium screening; 10. preoperative cognitive impairment as determined by a moca evaluation prior to surgery; 11. patients who are scheduled for 2 surgeries within 7 days of surgery; 12. patients with bone malignancy 13. currently participating in other clinical trials.

Keywords: postoperative delirium elderly orthopedics oxytocin nasal spray