Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics study of qing'e pill

Conditions: Menopause

Summary: this study will investigate the pharmacokinetics of single and multiple doses of qing'e pills in chinese menopause volunteers. the main components of qing'e pill into the blood such as psoralen and isopsoralen will be detected.


Eligibility criteria:
inclusion criteria: 1. women age between 40 to 60 years, suffering from irregular menstrual cycle or amenorrhea of 3-11 months. 2. moderate to severe hot flashes (associated with sweating)≥5 times /24 hours. 3. the score of kupperman index is not less than 15. 4. patients unused estrogen tablets or progesterone injection in 6 months. 5. patients must discontinue other therapies in the treatment of menopausal syndrome for more than 3 months. 6. get subjects informed consent process should comply with gcp requirements. exclusion criteria: 1. there is no clinical significance abnormal in physical and laboratory examination. 2. bilateral oophorectomy, endometrial lesions, uterine polyps, abnormal vaginal bleeding, severe breast hyperplasia, with family history of breast cancer. 3. patients with hypertension, primary hypotension and chronic anemia (hb ≤ 90 g/l). 4. patients with hyperthyroidism, coronary atheroma, diabetes, obesity (body mass index of more than 30 kg/m2), migraine, malignant tumors, thromboembolic disease, gastrointestinal diseases affect absorption or autoimmune diseases. 5. patients with diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mentally ill. 6. people with allergies. 7. people taking other drugs within 14 days before the trail. 8. patients are participating in other clinical trials within 3 months. 9. pregnant women. 10. alcoholics or smokers (past or smoking).

Keywords: menopause, pharmacokinetic
norcorp assessment clinic

Conditions: Covid19

Summary: the main overarching aim of this study is to build a research clinic, as part of the norcorp platform covering nottingham and nottinghamshire to facilitate learning and research in the whole population of patients who have had covid-19.

the severe acute respiratory syndrome-coronavirus-2 (sars-cov-2 / covid-19) pandemic, has affected over 13 million people, and caused significant worldwide mortality and morbidity. frequent long-term respiratory complications include persistent breathlessness and fatigue, with potential for ongoing organising pneumonia and new pulmonary fibrosis as well as thromboembolic disease. additional features seen in at least some patients post hospital include impaired musculoskeletal function, impaired renal function, neurological impairment, cardiac dysfunction and significant psychiatric morbidity. the majority of patients with covid-19 were not admitted to hospital, and the longer-term consequences of infection with sars-cov-2 in this much larger patient group are unknown. whilst many patients had relatively mild disease and made a good recovery, a significant number have been left with symptoms similar to those who were admitted to hospital. in setting up a post covid-19 respiratory review clinic, we expect to generate new findings, support studies that have already been submitted for funding, to provide a focus for further grant funding, and to provide an infrastructure to support new clinical trials. we also expect the insights gained from research using this platform to be of value for service planning in the region and beyond. we will prioritise patients who were not admitted to hospital but who have been left with significant morbidity by establishing this new general practitioner (gp) referral research clinic.

Eligibility criteria:
inclusion criteria: * adults (≥18 years) referred into the post covid-19 respiratory outpatient clinic from primary care, following a swab, imaging or strong clinical diagnosis of covid-19 * adults discharged from hospital with a clinical diagnosis of covid-19 (who are not included in the phosp-covid study) exclusion criteria: * children (\<18 years) referred into the post covid-19 respiratory outpatient clinic. this clinic is only open to adults and referrals for children will not be accepted * adults discharged from hospital with a clinical diagnosis of covid-19 and have been included in the phosp-covid study * patients unable to provide informed consent by themselves
ginsenoside improve metabolic syndrome

Conditions: Metabolic Syndrome

Summary: aim : investigated the effects of korean red ginseng supplementation on metabolic parameters such as cholesterol, blood pressure and glucose. randomized control trial.

methods : a randomized, double-blind, placebo-controlled, single-center study in 60 subjects who are not taking drugs that could affect metabolic and vascular function. subjects will be randomized into a korean red ginseng (3.0g/d) group or placebo group for a 4-week study. we will collect anthropometric measurements, blood for laboratory testing, inflammatory marker, hormones and mitochondrial dna copy number. subject : older than 40 years of age, presented with metabolic syndrome. subjects were excluded if they were taking drugs that could affect metabolic and vascular function, including bp control drug, anti-diabetic drugs and lipid-lowering drugs. measurement : we will collect anthropometric measurements and blood for laboratory testing at the initial(week 0) and final (week 4)visits. serum levels of blood glucose, insulin, total cholesterol, hdl-cholesterol,triglyceride, and dna copy number of mitochondria.

Eligibility criteria:
inclusion criteria: * metabolic syndrome exclusion criteria: * taking drug for lipid-lowering, bp control and anti-diabetic.
new clinical score for deep vein thrombosis

Conditions: Deep Vein Thrombosis

Summary: a new clinical score (cs) to rule out deep vein thrombosis (dvt) has to be derived and internally validated (with bootstrap method), from patients suspected of dvt in italy. primary care physicians (general practitioners) in lombardy will be instructed to inform patients suspected of dvt about this research and get in touch with the team to get details and, eventually, volunteer for the study. the cs includes categorical variables and a continuous variable: the differential leg skin temperature measured with a low-cost handheld infrared thermometer in object surface mode.


Eligibility criteria:
inclusion criteria: * patients suspected of deep vein thrombosis. exclusion criteria: * under 18 years of age
gerd infant feeding therapeutics trial (gift trial)

Conditions: GERD in Infants

Summary: the goal of this investigator-initiated, single-center, randomized controlled trial (rct) is to compare the effects of four weeks of three therapies on clinical and mechanistic outcomes based on ph-imp testing using a three-arm parallel design in nicu infants with objective gerd diagnosis. the three therapies being compared are natural maturation, proton pump inhibitor (ppi) use, and added rice (ar) formula use. the main goals are: * to evaluate and compare the efficacy of the three commonly used treatment interventions used in the nicu for gerd in a randomized controlled manner with the primary endpoint of oral feeding success and absence of troublesome symptoms (as defined below). * to characterize the mechanisms of primary end point (success or failure) using ph-impedance metrics.

in consented subjects, eligibility is determined after initial diagnostic 24-hour ph impedance test. these subjects will be randomized to one of the 3 arms of the study (natural maturation, ppi, ar formula) for 4 weeks of treatment. a second 24-hour ph impedance test will be done on therapy at 4 weeks or before discharge, whichever occurs first. primary outcome will also be measured at 4 weeks or at discharge, whichever comes first.

Eligibility criteria:
inclusion criteria: * nicu infants of any gestational age who are between 37 - 47 weeks postmenstrual age at inception of the study meeting the following requirements: * gerd diagnosis using ph-impedance criteria (acid reflux index ≥ 3% plus at least one of the following: # ger events \>70 / day, symptom associated probability ≥ 95%, discal baseline impedance \< 900 ω) * full enteral feeds * no current gerd therapies exclusion criteria: * known lethal chromosomal abnormalities or complex congenital syndromes * severe neurologic pathologies requiring neuroactive medications or neurosurgery * positive airway pressure or oxygen flow \> 4 lpm * upper gastrointestinal malformations requiring surgery

Keywords: proton pump inhibitor ph impedance added rice formula
three dimensional evaluation of nasolabial changes following classic vs without alar base suture after le fort i osteotomy

Conditions: Quality of Life

Summary: three dimensional evaluation of nasolabial changes following classic vs without alar base suture after le fort i osteotomy a randomized controlled clinical trial


Eligibility criteria:
inclusion criteria: 1. adult patients with skeletal maxillomandibular deformity indicated for surgical correction by le fort i osteotomy. 2. absence of growth. 3. patients must be willing for the surgical procedure and follow-up, with his informed consent. exclusion criteria: * 4. history of facial trauma with fractures of facial bones. 5. history of surgical operation in nasal region. 6. facial asymmetry. 7. patients with accompanying craniofacial syndromes. 8. patients with any diseases that compromise bone or soft tissue healing. 9. anterior open bite cases. 10. clefts ( lip and palate). 11. medically compromised patients not fit for general anaesthesia. 12. missing preoperative or postop-erative 3d photographs or cbct scans 13. multi-segment le fort i osteotomy 14. rhinoplasty surgery during or within 1 year after the le fort i osteotomy
cardiovascular risk factors in overweight adolescents

Conditions: Overweight; Obesity

Summary: the aim of the present study was to determine the effects of either a multidisciplinary approach or intensity-controlled interval training on cardiovascular risk factors in overweight adolescents.

several approaches have been used to improve cardiovascular health status and quality of life in obese children and adolescents, without coming to a consensus decision. recently, a few studies have determined the effects of exercise training and diet on endothelial function in overweight and obese children and adolescents. the main findings are that only a moderate amount of exercise training and diet changes improves or restores endothelial function. it is difficult, however, to asses the separate effects of the training and diet, particularly because none of the studies have used a homogenous exercise training regimen. unanimously, better, but affordable prevention and treatment strategies to improve wide-scale health outcome are called upon to slow down the current epidemic of overweight. it is now well established that physical activity reduces, but does not currently prevent the epidemic of obesity from either reaching global proportions or taxing public health and economy. despite the recent advances in understanding the responsible biology of improved cardiovascular health with exercise training, several lines of research questions are still unresolved. for instance, the optimal program, e.g. when to initiate, whom to prescribe exercise to, which exercise-intensity is required, and the actual design of the treatment program, remain by far yet to determine.

Eligibility criteria:
inclusion criteria: * overweight and obese adolescents in the trondheim area, referred to medical treatment at st. olav's hospital exclusion criteria: * any coexisting medical illnesses

Keywords: exercise training cardiovascular diseases risk factors
study to assess change in disease activity and adverse events of oral venetoclax with intravenous (iv) obinutuzumab in adult participants with recurring chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia (CLL)

Summary: chronic lymphocytic leukemia (cll) is the most common leukemia (cancer of blood cells). the purpose of this study is to assess retreatment with venetoclax-obinutuzumab (veng) in participants previously treated with fixed duration first-line (il) therapy of venetoclax in combination with an anti-cd20 antibody +/- x (where x is any additional drug). adverse events and change in disease activity will be assessed. venetoclax is an approved drug for the treatment of cll. study doctors put the participants in 1 of 2 groups, called cohorts, based on when symptoms of cll came back after previous treatment in first-line. approximately 75 adult participants with cll who have been treated with venetoclax in combination with an anti-cd20 antibody +/- x will be enrolled in the study in approximately 60 sites worldwide. participants will receive intravenous (iv) obinutuzumab + oral venetoclax (veng) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * documented diagnosis of chronic lymphocytic leukemia (cll) that requires treatment for cll according to international workshop for chronic lymphocytic leukemia (iwcll) 2018 criteria. * previously completed venetoclax + anti-cd20 antibody +/- x regimen as a fixed duration first-line (1l) therapy and achieved documented response, defined as complete remission, complete remission with incomplete marrow recovery, partial remission, or nodular partial remission. * more than 24 months (cohort 1) or 12-24 months (cohort 2) have elapsed between last dose of venetoclax and disease progression after completion of 1l treatment. exclusion criteria: - received intervening treatment for cll after completing previous treatment with a venetoclax + anti-cd20 antibody +/- x regimen.

Keywords: chronic lymphocytic leukemia (cll) venetoclax abt-199 venclexta gdc-0199 obinutuzumab gazyva ga101 cancer reveng
comparison of two different preload targets of stroke volume variation during kidney transplantation

Conditions: Kidney Transplant; Complications; Renal Failure Chronic

Summary: the investigators sought to compare the effect of two preload targets of stroke volume variation of ≤6% and ≤12% on the postoperative renal function in patients undergoing living donor kidney transplantation. goal-directed fluid therapy will be performed in both groups to maintain adequate stroke volume, stroke volume variation, mean arterial pressure (or systemic vascular resistance) during kidney transplantation. only the preload target for giving crystalloid during surgery will be different between groups.

the adequate preload target of fluid management has not yet been established during kidney transplantation. traditionally, sufficient intravascular volume status has been recommended to maintain perfusion to renal graft. stroke volume variation was reported to be superior to the traditional target of central venous pressure. in this regard, the investigators sought to compare the effect of two preload targets of stroke volume variation of ≤6% and ≤12% on the postoperative renal function in patients undergoing living donor kidney transplantation. goal-directed fluid therapy will be performed in both groups to maintain adequate stroke volume, stroke volume variation, mean arterial pressure (or systemic vascular resistance) during kidney transplantation. only the preload target for giving crystalloid during surgery will be different between groups.

Eligibility criteria:
inclusion criteria: * adults patients who are undergoing living donor kidney transplantation with continuous radial artery pressure monitoring exclusion criteria: * patients who have cardiac arrhythmia of atrial fibrillation, multiple ventricular premature complex * cardiac systolic dysfunction with left ventricle ejection fraction \<50% * continuous arterial pressure monitoring at the site other than radial artery. * patients who are considered to be intolerant to rapid fluid administration

Keywords: kidney transplantation preload index stroke volume variation goad-directed therapy
the effect of perioperative dexamethasone administration on postoperative pain in patients undergoing periacetabular osteotomy.

Conditions: Dexamethasone; Hip Dysplasia; Postoperative Pain; Postoperative Nausea and Vomiting

Summary: this is an investigator-initiated, danish mono-center, randomized, placebo-controlled, parallel group, double-blind, superiority trial of dexamethasone on postoperative pain management on patients undergoing operation for hip dysplasia with the periacetabular osteotomy procedure (pao). 90 adults undergoing pao will be enrolled. the primary outcome is to compare the effect of dexamethasone relative to placebo on cumulated postoperative morphine consumption at 48 hours. key secondary outcomes include comparing the effect of repeated doses of dexamethasone relative to a single dose on cumulated postoperative morphine consumption at 48 hours, and to determine if dexamethasone is superior to placebo for: perception of pain intensity, prevalence and degree of postoperative nausea and vomiting, and patient-reported outcome measures.


Eligibility criteria:
inclusion criteria: * patients undergoing pao due to symptomatic hip dysplasia (ce\<25grader) or retroverted acetabulum (crossover and posterior wall sign) * ≥ 18 years * females if fertile: verified negative human chorionic gonadotropin (hcg), usage of safe contraceptives or surgical sterilisation. * patients who give their written informed consent to participating in the trial, after having fully understood the content of the protocol and restrictions. exclusion criteria: * patients who cannot speak or understand danish * allergy or contraindications to trial medication * spinal anaesthesia * second intervention carried out simultaneously (e.g. femur osteotomy) * patients with daily opioid consumption prior to surgery (tramadol and codeine accepted) * drug, medical abuse or weekly alcohol consumption beyond ≥7 (female) and ≥14 (men) units, respectively. * mental disability, anxiety disorder (active psychiatric disorder or consumption of tricyclic antidepressants) * diabetes diagnosed prior to inclusion * immune suppression therapy (e.g. systemic glucocorticoids) * kidney impairment (egfr \< 50ml/min) or liver disease (≥child pugh b)

Keywords: postoperative pain dexamethasone pain management
hyperbaric oxygen therapy as adjunctive therapy to scaling and root-planing in the management of periodontitis in patients with type 2 diabetes

Conditions: Diabetes; Periodontitis

Summary: diabetes and periodontitis are both prevalent diseases affecting millions of americans. periodontitis is prevalent among diabetics. furthermore, periodontitis and associated inflammation can increase insulin resistance in diabetics and worsens the condition. hyperbaric oxygen therapy (hbot) has the potential to improve periodontal treatment outcome in poorly controlled diabetics. the study will compare periodontal treatment (srp) outcome between 2 main diabetic type 2 patient groups receiving medical care treatment: either conventional wound therapies (cwc) with or without adjunctive hyperbaric oxygen therapy at llu health. 24 poorly controlled diabetic mellitus (dm) type 2 subjects (hba1c =\>7%) with periodontitis will be assigned into the study arms hbo therapy and non hbo therapy, based on their medical needs. for all subjects demographic data (age, gender, ethnicity, smoking history, alcohol use history, bmi, current medication list) and oral health habits will be obtained. blood samples for hba1c determinations, clinical periodontal measurements (plaque index, probing measurements including pocket depth, attachment levels, gingival index and bleeding-on-probing) and subgingival microbial samples will be obtained at baseline and end of the study. subgingival microbial samples will be collected from three randomly selected sites and analyzed for detection of about 300 of the most prevalent oral bacterial species. differences in periodontal clinical outcomes and bacterial profiles will be identified utilizing ancova (analysis of covariance).


Eligibility criteria:
inclusion criteria: * diabetes type 2 (hba1c =\>7%) * generalized moderate to severe chronic periodontitis. * minimum of 10 permanent teeth * registered llu patients exclusion criteria: * well controlled diabetes type 2 * other systematic conditions with known associations to periodontitis * intra-oral conditions which may interfere with the accuracy of periodontal probing * bmi greater than 45%
chinese severe brain injury trial

Conditions: Severe Brain Injury

Summary: building a large chinese cohort(chinese severe brain injury trial）


Eligibility criteria:
inclusion criteria: * a clear cause of brain injury * disorders of consciousness, gcs≤12 * within six months of onset exclusion criteria: * not applicable
telemedicine in outpatient covid-19 patients

Conditions: Covid-19; Cardiovascular Risk Factor

Summary: covid-19, a commonly severe respiratory tract infection caused by the sars-cov2 coronavirus, poses an increasing threat to individual health and health care systems. the individual disease course ranges from mild to life threatening, the pandemic spread leads to a shortage of health care resources including intensive care availability. it should be the overarching goal to allocate sparse health care resources to those most at need and to simultaneously avoid unnecessary blocking of resources by clinically unjustified hospitalizations. individuals with preexisting cardiovascular conditions are at the highest risk of health deterioration, even at younger age. objective criteria for hospitalization are not immediately available in a outpatient settings. hence, hospitalization and emergency medical contact is often triggered by subjectively interpreted symptoms. the goal of this project is thus to improve the availability of objective measurements in the outpatient setting by means of an innovative, smartwatch mediated telemedicine approach. to achieve this goal, the investigators will conduct a randomized clinical trial comparing a smartwatch based telemedicine intervention with standard of care. the intervention group will receive regular objective measurements of heart rate, ecg, and spo2 and will get access to a 24/7 medical care hotline for consultation. the investigators hypothesize that the intervention group will benefit by a significant reduction in unnecessary hospitalizations and unplanned emergency medicine contacts.


Eligibility criteria:
inclusion criteria: * confirmed sars-cov2 infection and clinical covid-19 disease * age ≥18 years * presence of ≥1 relevan cardiovascular condition, defined as (or): * atrial fibrillation * systolic or diastolic heart failure * lv ejection fraction \<50% * coronary artery disease with past pci or cabg * past myocardial infarction * diabetes mellitus * arterial hypertension (treated or untreated) * active smoking * chronic obstructive lung disease * obesity (bmi ≥30kg/m2) * availability of smartphone and sufficient internet connectivity at home * ability to use smartwatch * informed consent to study participation and data protection concept exclusion criteria: * participation in concurrent clinical trial * indication for hospitalization at study entry

Keywords: sars-cov2 covid-19 cardiovascular disease telemedicine ecg spo2