Kornimate/medical-research-clean huggingface dataset:
efficacy, immunogenicity and safety of inactivated vaccine (coronavac) against sars-cov2 in children and adolescents

Conditions: COVID-19

Summary: to evaluate the efficacy and safety of vaccinating children and adolescents, aged 3 to 17 years, with a two-dose schedule of the inactivated vaccine (coronavac) against sars-cov-2.

nine hundred sixty (960) participants will be randomized into 2 groups, in a 2:1 ratio, to receive the inactivated coronavac/butantan vaccine (vacc, n=640) and a group to receive the immunizing bnt162b2 (pfizer) (bntc, n=320). the vacc group will also be compared to a group of adults aged 18 to 49 who received coronavac (adu, n=160). the main outcome will be the geometric title of neutralizing antibodies and the secondary outcomes will be the incidence of the number of cases confirmed by rt-pcr, the cellular immune response and frequency of adverse events. outcomes will be evaluated before the first dose, and 28 and 90 days after the second dose, and followup after 6 and 12 months. the study hypothesis is that the cellular and humoral immune response of children and adolescents is not inferior to the age group 18 to 49 years, who received coronavac and compared to children vaccinated with the immunizing bnt162b2 (pfizer) and that the inactivated vaccine presents lower reactogenicity for the age group studied.

Eligibility criteria:
inclusion criteria: * age between 3 and 17 years old (vacc and bntc groups) * age between 18 and 49 years old (adu group) exclusion criteria: * pregnant teenagers; * history of severe allergic reaction (anaphylaxis, urticaria or angioedema) to any previously administered vaccine; * have previously received a vaccine against covid-19; * personal history of sars-cov-2-related multisystem inflammatory syndrome (mis-c); * immunosuppressed due to conditions such as inborn error of metabolism, hiv infection, neoplasia or use of immunosuppressive drugs (systemic corticosteroids for more than 14 days or another immunosuppressant).

Keywords: covid-19 vaccine children coronavac vero cell
effects of liposuction and exercise training on metabolism, lipid profile and adiposity in women

Conditions: Healthy Subjects

Summary: liposuction is the most popular aesthetic surgery in brasil and worldwide. evidence showing that adipose tissue is a metabolically active tissue led to the suggestion that liposuction could be a viable method for the improvement of metabolic profile through the immediate loss of adipose tissue. studies about the effects of liposuction on metabolic profile are conflicting. a few studies report the improvement of insulin sensitivity, inflammatory markers and lipid profile, others observe no changes and a few report the worsening of metabolic profile. in addition, animal studies show a compensatory growth of intact adipose tissue in response to lipectomy. physical exercise improves insulin sensitivity, lipid profile, inflammatory balance, adipose tissue distribution and increases or preserves free fat mass. therefore, liposuction and physical exercise seem to act on similar tissues of the body. to the investigators knowledge, there are no studies about the associated effects of liposuction and exercise in humans. however, one can suggest that exercise training associated with liposuction could: \[1\] attenuate or block the possible fat recovery or compensatory growth; \[2\] block or reverse the possible harmful effects of liposuction; or \[3\] exert an additive or synergistic effect to the possible beneficial effects induced by liposuction on metabolic and hormonal profile and inflammatory balance.


Eligibility criteria:
inclusion criteria: * 20 to 35-year old healthy subjects with a bmi of 22 to 28 kg/m2; * non-smokers; * present stable body weight for 6 months (without variations exceeding 4 kg); * be in use contraceptive pill for at least 6 months; exclusion criteria: * health problems that impede surgery or exercise training; * be in chronic use of antibiotics or antiinflammatory medication.

Keywords: liposuction exercise metabolism adiposity
total knee replacement using simplex® or cobalt™ bone cement

Conditions: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Knee Arthritis

Summary: the purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using simplex® or cobalt™ bone cement.

the purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using simplex® or cobalt™ bone cement.

Eligibility criteria:
inclusion criteria: * patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved * patients requiring correction of varus, valgus, or posttraumatic deformity * patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure exclusion criteria: * infection, sepsis, and osteomyelitis
the impact of noise on requirements of anesthetics during general anesthesia

Conditions: Anesthesia

Summary: the investigators hypothesize that the noise level in the operating theatre influences the patients' requirements of anesthetics. study subject are patients undergoing abdominal surgery in combined general and epidural anesthesia. analgesia is maintained by epidural injections of sufentanil and ropivacaine whereas general anesthesia is maintained using the inhalational anesthetic desflurane. desflurane requirements are adjusted using neuromonitoring (bis-index). intraoperative noise levels are recorded. patients are randomized to receive hearing protections or not.

all patients receive standardized anesthesia and monitoring according to the usual clinical care in the department. placement of epidural catheters takes place before induction of general anesthesia. thereafter, 10 ml ropivacaine 0.3% with 10 µg sufentanil are administered epidurally every 60 min to induce and maintain analgesia during surgery. following induction of general anesthesia and tracheal intubation, intraoperative hypnosis is maintained using desflurane.

Eligibility criteria:
inclusion criteria: * full contractual capability * written informed consent * abdominal surgery in combined general/epidural anesthesia * position during surgery: supine * clinically normal hearing exclusion criteria: * history of psychiatric disease * history of intraoperative awareness * clinically impaired hearing * contraindication for placing an epidural catheter

Keywords: anesthesia, inhalation hearing noise, occupational
atbs for treatment of depression in aud

Conditions: Alcohol Use Disorder; Depression

Summary: this study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for improvement of depressive symptoms and drinking behavior in individuals with alcohol dependence. in this open label study, all participants will receive accelerated theta-burst stimulation.

repetitive transcranial magnetic stimulation (rtms) is a noninvasive procedure and an established technology. research utilizing rtms in patients with alcohol use disorder has shown some promising results. the limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). recently, researchers have aggressively pursued modifying the treatment parameters, such as using accelerated intermittent theta-burst stimulation (aitbs), to reduce treatment times with possible enhanced efficacy with some preliminary success. this study intends to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.

Eligibility criteria:
1. participant aged 18-65 years old with diagnosis of alcohol use disorder. 2. participant may also choose to or not to take pharmacotherapy during the study period. 3. participant has tried at least one medication in the past that has not helped the alcohol use disorder. if participants are taking medication, they must be on stable psychotropic medication or psychotherapy for at least 6 weeks prior to the study with plans to continue throughout study enrollment. 4. participant needs to be at least one week after last alcohol/ substance use and had the last drink within one year of the beginning of the study participation. 5. participant endorses depressive symptom(s), indicated by a mards score \>= 20. 6. all participants must be assigned to a psychiatrist and agree to continue to be assigned to a psychiatrist throughout study enrollment. 7. able to read, understand, and provide written, dated informed consent prior to screening. participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.

Keywords: depression tms transcranial magnetic stimulation theta burst alcohol use disorder alcohol addiction
the effect of transaortic valve replacement on the endothelial integrity and function

Conditions: Degenerative Aortic Valve Stenosis

Summary: degenerative aortic valve stenosis (avs) is the leading cause of aortic valve morbidity with a prevalence of 2-7% at ages above 65 years, with ever-increasing incidence especially in the 8th decades. avs is independently associated with atheroclerosis risk factors and clinically apparent cv disease indicating that the degeneration of the aortic valve may represent an atheroclerosis-like process involving both, the aortic valve as well as the vascular system, respectivel. it is still unknown whether the endothelial function is affected as an manifestation of the atherosclerotic process, changes in the driving mechanical forces as wss downstream of the valve, or other factors beyond physical pressure effects. the investigators hypothesized that altered haemodynamics may at least partly be responsible for observed endothelial dysfunction in patients with avs. therefore, the aim of this study is to investigate whether the resolution of avs by transaortic valve implacement (tavi) affects wss, improves endothelial dysfunction and decreases levels of circulating emps as markers of endothelial integrity.


Eligibility criteria:
inclusion criteria: * aortic valve stenosis * screened for tavi * written informed consent exclusion criteria: * no written informed consent * patients with acute infections (crp\> 0.5 mg / dl) * patients with atrial fibrillation * patients with inflammatory and malignant diseases

Keywords: transaortic valve replacement (tavi) endothelial function circulating microparticles
tw her2 positive breast cancer productivity & utility study

Conditions: HER2-positive Breast Cancer

Summary: breast cancer ranks top 4 taiwan mortality cause in 2016 and the incidence rate has been increasing. since advances in screening and treatment over last decades, disease-free survival in her2 positive breast cancer improved and relapse rates decrease as well. while health-related quality of life (hrqol) and productivity benefit is not currently formally assessed by taiwan health technology agency (hta) in taiwan, the value of therapy in terms of a wider societal benefit is a critical factor which is increasingly being considered as part of the overall assessment of the value of a new medicine. sort of productivity study in cancer is lack of in taiwan. referenced roche uk team published comprehensive productivity studies1 taiwan epidemiology association wants to initiate study to understand holistic value in each stage of breast cancer and quantify the value of new drug to support hta assessment. the data will be collected through study, and adapt to cost-effectiveness model for future reimbursement submission.

breast cancer ranks top 4 taiwan mortality cause in 2016 and the incidence rate has been increasing. since advances in screening and treatment over last decades, disease-free survival in her2 positive breast cancer improved and relapse rates decrease as well. while health-related quality of life (hrqol) and productivity benefit is not currently formally assessed by taiwan health technology agency (hta) in taiwan, the value of therapy in terms of a wider societal benefit is a critical factor which is increasingly being considered as part of the overall assessment of the value of a new medicine. sort of productivity study in cancer is lack of in taiwan. referenced roche uk team published comprehensive productivity studies1 taiwan epidemiology association wants to initiate study to understand holistic value in each stage of breast cancer and quantify the value of new drug to support hta assessment. the data will be collected through study, and adapt to cost-effectiveness model for future reimbursement submission.

Eligibility criteria:
inclusion criteria: * aged 18 years or over; * diagnosed with early stage or metastatic (stage iv) her2-positive breast cancer (confirmed by the study site physician). \[her2-positive is defined as ihc3+ and/or ish≥2.0\] * ebc patients should have received at least 2 cycles of adjuvant anti-cancer therapy following surgery at time of interview; metastasis breast cancer (mbc) patients should have received at least 1 cycle of treatment for their metastatic disease at time of interview. * able to provide written, informed consent. exclusion criteria: * patients with ecog performance status (ps) ≥3 * unwilling or unable to provide written, informed consent * unable to complete written quality of life questionnaires

Keywords: her2-positive breast cancer work productivity health-related quality of life
effectiveness of of therapeutic currents in clinical dimension and penetration depth dimension in lower back

Conditions: Pain

Summary: electrical stimulation therapy for pain reduction was performed already 2000 years ago. in recent years many studies had proved the effectiveness of electrical stimulation in pain management, tissue healing and muscle strengthening. today there are devices with many types of currents. each current comes with different statements for its effectiveness and its penetration depth yet there is no consensus on the most effective current in the dimension of penetration depth.

the study shall be recruited patients who underwent implantation of electrodes in the spine (spinal cord stimulation- scs). the electrode will serve as a voltage reader deep in the tissue. the voltage is generated from electrodes applied on the skin and delivers therapeutic currents to the patients back. the study will be tested 4 different types of currents and number of electrode placement.

Eligibility criteria:
inclusion criteria: * normal cognitive status. * language comprehension (understanding and speaking)a way that allows voluntary cooperation in research and compliance with the testing. exclusion criteria: * pregnant women. * neurological pathologies (such as -head injury) or other systemic diseases that affect the sensation (such as diabetes). * each participant which at any stage in research expresses his wish to resign.
safety and efficacy study of ethosuximide for the treatment of complex regional pain syndrome (crps)

Conditions: Complex Regional Pain Syndromes

Summary: pain remains the most debilitating symptom for adult patients suffering from complex regional pain syndrome (crps). most crps patients gain little to no relief from current painkillers. the purpose of this study is to evaluate the efficacy and safety of ethosuximide in search of much-needed adjunctive therapy to relieve the pain and suffering associated with crps.

this is a single centre, parallel-group, double-blind, randomized, placebo-controlled pilot clinical trial for adults suffering from complex regional pain syndrome (crps). twelve (12) subjects diagnosed with crps will be enrolled and randomized to receive orally, either ethosuximide or placebo. if the maximum trial medication dosage (1500mg) is reached, the subject will be in the study for a maximum of 10 weeks from screening (clinic visit 1) to the end of the drug cessation period. the minimum period a subject could complete the study would be 4 weeks presuming they were not previously on any disallowed drugs and only found the 500mg dose tolerable.

Eligibility criteria:
inclusion criteria: * male or female, age ≥18 years old; * diagnosis of complex regional pain syndrome (crps) using international association for the study of pain criteria \>6 months; * normal liver function (ast level \<3x normal level); * normal kidney function (serum creatinine \<133µmol/l); * full blood count, haematocrit \>38%; * willing and able to give informed consent and of completing study questionnaires; * stable (no change in past two months) but suboptimal pain pharmacotherapy (i.e. additional pain control felt by patient and physician to be necessary); * able to attend research centre according to the visit schedule; * women of child-bearing potential must be using a reliable form of contraception i.e. oral contraceptives, a barrier method (condom or diaphragm), intra-uterine device or abstinence. exclusion criteria: * optimal response to opioids, antidepressants, anticonvulsants or anti- inflammatory medications; * any history or indication of kidney or liver disease; * any history of alcohol abuse; * presence of diabetes; * subjects taking other anti-epileptic drugs, including gabapentin, pregabalin, topiramate, phenytoin, carbamazepine, and oxcarbazepine; * pregnancy (a serum bhcg pregnancy test will be performed as part of the initial blood panel); * known or suspected allergy to succinimides, ethosuximide, methsuximide (celontin®), phensuximide; * any history of mental illness or disorder, which in the investigators opinion, interferes with the subjects ability to accurately report treatment response; * participation in other clinical trial in the 30 days prior to enrolment.

Keywords: complex regional pain syndrome reflex sympathetic dystrophy rsd chronic pain ethosuximide zarontin anticonvulsant
multi-parametric functional mri in patients of chronic kidney disease

Conditions: Chronic Kidney Disease(CKD); MRI

Summary: to explore the value of mr fingerprinting-generated quantitative maps combined with asl renal perfusion imaging in the assessment of renal impairment in chronic kidney disease.

chronic kidney disease (ckd) has become an important public health problem threatening human health worldwide. the prevalence rate of ckd in chinese adults is 10.8%, but the awareness rate and diagnosis rate are generally low. at present, the assessment of renal impairment in ckd mainly relies on laboratory tests, such as estimated glomerular filtration rate (egfr) and urinary protein/creatinine ratio, and the value of functional mri in the assessment of renal impairment in patients with ckd is unclear. as a new sequence still in the scientific research stage, mr fingerprinting can simultaneously generate quantitative t1 maps, t2 maps and proton-weighted images in one breath holding scan, with short scanning time, high repeatability and accuracy. it has been proved that quantitative techniques of t1 mapping and t2 mapping are valuable for evaluating the degree of renal fibrosis and water content. kidney is a blood-rich organ, and the blood flow of kidney is of great significance to the evaluation of renal function. asl uses hydrogen protons in arterial blood as an endogenous tracer to evaluate tissue blood perfusion, and can quantitatively evaluate renal blood perfusion in patients with ckd without the use of exogenous contrast agents, avoiding the risk of aggravated renal damage and nephrogenic fibrosis caused by injection of gadoline-containing contrast agents. the objective of our study was to explore the value of mrf sequence-generated quantitative maps combined with asl renal perfusion imaging in the assessment of renal impairment in chronic kidney disease.

Eligibility criteria:
inclusion criteria: * patients diagnosed with chronic kidney disease (ckd) by renal biopsy exclusion criteria: * patients with serious underlying diseases * patients with mri incompatible metal implants and contraindications such as claustrophobia * patients with imperfect clinical data and pathological data

Keywords: chronic kidney disease mr fingerprinting asl
cross-over study to prove bioequivalence between two oral formulations of levonorgestrel

Conditions: Contraception; Contraception, Postcoital

Summary: a single dose, two treatments (postday and opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 21 days between the two study periods. treatment groups were balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.


Eligibility criteria:
inclusion criteria: * healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ecg), blood chemistry, liver function profile and urinalysis. exclusion criteria: * history of illnesses or any organic abnormalities that could affect the results of the study. * history of abuse tobacco or alcohol or regular use of recreational or therapeutic drugs. * subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.
a study to evaluate the efficacy and safety of karxt in acutely psychotic japanese adult participants with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the efficacy and safety of karxt in acutely psychotic japanese adult participants with schizophrenia


Eligibility criteria:
inclusion criteria * participants must have a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the diagnostic and statistical manual of mental disorders⎯fifth edition (dsm-5) criteria and confirmed by mini international neuropsychiatric interview (mini). * participants must have a panss total score between 80 and 120, inclusive. * participants must have a cgi-s score of ≥ 4. exclusion criteria * participants must not have any primary dsm-5 disorder other than schizophrenia within 12 months before screening. * participants must not be newly diagnosed or experiencing their first treated episode of schizophrenia. * participants must not have any history or presence of clinically significant medical conditions. * other protocol-defined inclusion/exclusion criteria apply.
rural appalachia pilot water treatment trial

Conditions: Water-Related Diseases; Enteric Pathogens; Exposure to Chemical Pollution

Summary: consumption of unsafe drinking water is associated with a substantial burden of disease globally. in the usa, the burden of disease associated with consumption of contaminated drinking water from non-regulated private wells and springs in rural areas is relatively understudied and unclear. for some lower-income households in rural areas of the usa without access to reliably safe drinking water, point-of-use treatment with relatively low-cost pitcher filters could help to reduce exposures to contaminated water and associated adverse health outcomes. this pilot randomized controlled intervention trial will provide information and data on water quality and contamination exposures, associated health outcomes, and the adoption potential of point-of-use water filters in rural areas of virginia and tennessee.


Eligibility criteria:
inclusion criteria: * the household does not have utility-supplied water at the time of enrollment, * the household is considered to be "low-income" (based on federally defined income limits), * the household is in one of the selected study counties in tn or va. exclusion criteria: * none (no exclusion criterion based on gender, race, ethnicity, language, or literacy).