Kornimate/medical-research-clean huggingface dataset:
to evaluate the pharmacokinetics and safety of oral administration of br9001 compared with br900a in healthy subjects

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the pharmacokinetics and safety of oral administration of br9001 compared with br900a in healthy subjects

this is an open-label, randomized, crossover study to evaluate the pharmacokinetics and safety. within each period, randomized subjects will be take 2 dosing regimens that br9001 or br900a.

Eligibility criteria:
inclusion criteria: * adults 19-50 years of age * body mass index (bmi) ≥ 18.5 and ≤ 27.0 kg/m\^2 at screening * medically healthy with no clinically significant medical history * no clinically significant result with laboratory test including chemistry, serum, urine test within 3 weeks in prior to administration of investigational product * understands the study procedures in the informed consent form (icf), and be willing and able to comply with the protocol exclusion criteria: * history or presence of clinically significant medical or psychiatric condition or disease. * positive results at screening for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv). * creatinint clearance \< 80 ml/min (using cockcroft-gault) at screening. * whole blood donation within a 2 months prior to the first dose of study drug. * participation in another clinical trial or bioequivalence study within 12 weeks prior to the first dose of study drug(s).

Keywords: generic
evaluating huddles as a novel approach to improving concussion safety

Conditions: Mild Traumatic Brain Injury

Summary: investigators will conduct a randomized controlled trial assessing the effectiveness and implementations of pre-game safety huddles (huddles) in youth soccer.

the clinical trial portion of this study will enroll 16 youth soccer leagues within four us states. within each participating league we will enroll two "brackets" (closed units of teams at the same level that compete against each other during the regular season of play) of u12 boys' and girls' u12 teams. based on typical league and bracket size we anticipate will be 384 teams. randomization will happen at the league-level. leagues in the huddle intervention condition will be supported by us soccer in implementing pre-game safety huddles before each regular season game. leagues in the control condition will continue us soccer's standard concussion education prevention activities. our primary effectiveness and implementation outcomes will be measured at the end of the regular season of play (anticipated to be 10 weeks). maintenance outcomes will be measured at the end of the regular season of play one year later.

Eligibility criteria:
inclusion criteria: * children between the ages of 9 and 13 on eligible teams in participating leagues. * soccer coaches of children between the ages of 9 and 13 on eligible teams in participating leagues. * read and write english exclusion criteria: * cannot read and write english

Keywords: concussion brain injury prevention
the effect of testosterone replacement on the high density lipoprotein cholesterol subgroups

Conditions: Secondary Hypogonadism

Summary: the study is designed to answer the following questions: 1. is there any difference between the compositions of the hdl cholesterol subpopulations of patients with hypogonadism and the healthy controls. 2. what is the effect of testosterone replacement therapy on the distributions of hdl subgroups. 3. is there any difference between the effects of the two different testosteron replacement regiments

this study has two designs: 1. the case control design to search for the difference between the hdl subgroups and the other metabolic parameters between the healthy subjects and the patients with hypogonadism 2. the follow-up study to search for the effects of two different testosterone replacement regiments.

Eligibility criteria:
inclusion criteria: * congenital hypogonadotrophic hypogonadism, * male sex exclusion criteria: * previous history of androgen replacement, * any chronic disorder

Keywords: hypogonadism testosterone hdl cholesterol subgroups hscrp homa-ir
comaprison between qlb and espb in patients for pcnl operation

Conditions: Pain, Postoperative

Summary: comparing the subcostal oblique quadratus lumborum block and the erector spinae plane block in patients undergoing percutaneous nephrolithotomy operation to get the best and longest postoperative analgesic effect.

here the investigators are going to compare between the anterior approach for the subcostal oblique quadratus lumborum block (qlb) and the erector spinae plane block (espb) to determine their level of spread and their value in controlling postoperative pain in patients scheduled for percutaneous nephrolithotomy surgery. we hypothesized that quadratus lumborum is not inferior regarding the duration of analgesia when compared to erector spinae in patients undergoing percutaneous nephrolithotomy under general anesthesia.

Eligibility criteria:
inclusion criteria: * both sex * age: 18-60 * asa (american society of anesthesiologists) class i and ii * elective surgery * patients undergoing pnl surgery exclusion criteria: * patient's refusal * allergy or contraindications to drugs used in the study * emergency surgery * psychiatric disorders * severely co-morbid patients * inflammation or infection over injection site * bleeding diathesis; inr more than 1.5 and platelet count less than 100,000/mm3 * peripheral neuropathy * obese patients bmi ≥35 * patients on previous opioid therapy * pre-operative haemoglobin \<10 mg/dl * inability to properly describe postoperative pain to investigators * coagulation abnormalities * history of drug addiction or alcohol abuse * history of previous renal surgery

Keywords: pain management nephrolithotomy qlb espb erector spinae quadratus lumborum anesthesia ultrasound regional anethesia
nf1-attention: study of children with neurofibromatosis type 1 treated by methylphenidate

Conditions: Neurofibromatosis Type 1

Summary: neurofibromatosis type 1 (nf1) is an autosomal dominant disorder with an estimated prevalence of 1/2190 to 1/6711. attention deficit hyperactivity disorder (adhd) has been reported to be common in nf1. we, the researchers at hospices civils de lyon, designed a randomized, double blind, placebo controlled, crossover trial with a total follow-up duration of 9 weeks to evaluate the effect of methylphenidate (mph) on the improvement on the simplified parents conners' rating scale. in a parallel exploratory study we will compare the nature of attention deficit disorders in nf1 children to 30 adhd nf1-free controls. children aged 7 to 12 years are eligible when their intelligence quotient (iq) is between 80 and 120. fifty subjects (25 for each period) were required for testing the primary study hypothesis.


Eligibility criteria:
inclusion criteria: * age 7-12 years * iq between 80-120. * gender: male or female * children with neurofibromatosis type 1 (according to the national institutes of health \[nih\] 1988). * patients with school difficulties pointed out by parents or teachers * patients with attention difficulties as defined by anamnesis exclusion criteria: * iq \> 120 or iq \< 80 * child depression * unwillingness to participate * patients with cerebral complication of neurofibromatosis type 1 (chiasma glioma, moya-moya) as detected by cerebral magnetic resonance imaging (mri). * participation in another study

Keywords: neurofibromatosis type 1 attention deficit with hyperactivity disorder school difficulties methylphenidate
assessment of the efficacy, tolerability and pharmaco-economic impact of zoledronic acid treatment in prostate cancer with bone metastasis

Conditions: Prostate Cancer With Bone Metastasis

Summary: study to determine effectiveness and safety of zoledronic acid and whether it has a pharmaco-economic impact in prostate cancer with bone metastasis.


Eligibility criteria:
inclusion criteria: * aged ≥18 years. * written informed consent. * with histologically-proven prostate carcinoma. * ecog performance status ≤ 2 * life expectancy \> 12 months * current or previously documented diagnosis of at least 1 bone metastasis due to prostate cancer (patient could be hormono naif, hormono sensible or hormono refractory) * patients with partners of childbearing potential should use a barrier method of contraception throughout the study. exclusion criteria: * ecog performans status \>3 * prior treatment with bisphosphonates iv within the last 3 month to the study * renal insufficiency (serum creatinine \> 265 micromol/l or \> 3.0 mg/dl) * liver function tests \> 2.5 uln * patients with another nonmalignant disease which would confuse the evaluation of primary endpoints or prevent the patient from complying with the protocol. * history of concomitant disease with influence on bone metabolism such as paget's disease or primary hyperparathyroidism * disabling or non controlled concomitant disease likely to alter the quality of life * patient unable to fill in a questionnaire: senile dementia, psychiatric or neurological disease, illiterate or partially sighted patient * known hypersensitivity to zoledronic acid or other bisphosphonates other protocol-defined inclusion / exclusion criteria may apply.

Keywords: prostate cancer bone metastasis zoledronic acid
faslodex international observational non-interventional study in advanced breast cancer (bc)

Conditions: Breast Cancer

Summary: the purpose is to collect real life data on the use of fulvestrant in normal clinical practice in austria and document the clinical benefit of fulvestrant treatment.


Eligibility criteria:
inclusion criteria: * postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer * ability to read and write and complete questionnaires * provision of written informed consent * patients who already received a prescription for fulvestrant exclusion criteria: * a subject who does not fulfil all the above mentioned inclusion criteria is not allowed to participate in this nis

Keywords: fiona faslodex advanced breast cancer real life data collect real life data in clinical practice across austria
pd-1 antibody improve mixed chimerism

Conditions: PD-1 Antibody; Mixed Chimerism

Summary: pd-1/pd-l1 pathway play an important role in inhibiting the function of antigen-specific cd8+t cells, thus matter a lot in immune escape. we intend to use pd-1 antibody to improve the function of lymhocyte and improve the chimerism in patients after allo-hct.

mixed chimerism is a trouble condition after allogeneic hematopoietic cell transplantation (allo-hct),all targeted treatment are aimed to improve the function of lymphocyte recipient. pd-1 antibody was reported to restored the function of impaired lymphocyte. therefore, we want to use pd-1 antibody to improve the function of lymhocyte and improve the chimerism in hlh patients after allo-hct.

Eligibility criteria:
inclusion criteria: 1. ebv-hlh according to the hlh-04 diagnostic criteria. 2. after allo-hct, have achieved engraftment and reconstitute of hematopoiesis. have achieved full donor chimerism. 3. withdraw immunosuppressive agent, chimeric rate was 80%-95% 4. age \>18 years old, gender is not limited. 5. no graft-versus-host disease was observed. 6. no secondary graft failure (anc \<0.5\*10\^9/l,plt \<10\*10\^9/l) 7. before the start of the study, aminopherase (alt/ast) and total bilirubin were normal. serum creatinine ≤ 1.5 times the upper limit of normal (uln); no thyroid dysfunction. the left ventricular ejection fraction (lvef) was normal. 8. informed consent. exclusion criteria: 1. allergic to the test drug ingredients or to a more severe allergic constitution. 2. chimeric rate continue to decline after 2 weeks of toripalimab injection used. 3. serious immunoreaction: myocardial damage, hepatitis, pneumonia. 4. central nervous system symptoms. 5. serious mental illness. 6. active bleeding of the internal organs 7. uncontrollable infection； 8. pancreatitis history. patients unable to comply during the trial and/or follow-up phase; 9. participate in other clinical research at the same time.

Keywords: chimerism pd-1
use of technology and telemedicine to improve quality of care in covid 19 patients

Conditions: Diagnoses Disease; Covid19

Summary: the purpose of this study is to assess the use of technology including remote vital sign monitoring in improving quality of patient care, decreasing hospital admissions and re-admissions, decreasing hospital length of stay and decreasing use of personal protective equipment.


Eligibility criteria:
inclusion criteria: * hospitalized patient with covid 19 or outpatient under investigation for or diagnosed with covid 19 * clinically stable (on 4l o2 or less, non icu) * demonstrates ability to be trained in use of digital stethoscope technology exclusion criteria: * pregnancy * delirium

Keywords: telemedicine
clinical study of tuti-16 in asymptomatic hiv-1 infected subjects

Conditions: HIV Infections

Summary: this protocol represents the first in human study of tuti-16, and is being conducted to establish the safety and human immunogenicity (anti-hiv-1 tat titers) of subcutaneously administered tuti-16. activity of tuti-16 will also be determined in minimizing hiv-1 viral loads and sustaining cd4+ t-cell levels.

hiv-1 tat protein, a virally encoded toxin, is secreted by hiv-1 infected cells and acts on uninfected cells, rendering them permissive for hiv-1 replication. hiv-1 tat enhances chronic viral replication and induces immune suppression. antibodies to tat inhibit this tat-mediated transcellular activation in vitro and minimize chronic plasma viremia. hiv-1 tat activities can be blocked in vitro and in vivo by anti-tat antibodies. the thymon universal tat immunogen (tuti-16) is a fully synthetic, self-adjuvanting lipopeptide vaccine that is water soluble and administered by subcutaneous injection. in preclinical studies, a priming dose and a three week boost in rats induced a high titer antibody response to the eight known distinct epitope variants of hiv-1 tat protein. these antibodies block the function of the hiv-1 tat protein (toxin), which is essential to the maintenance of chronic hiv-1 viremia. therefore, tuti-16 has potential as a therapeutic vaccine for hiv-1 in humans.

Eligibility criteria:
inclusion criteria: * males and females * age ≥18 and ≤50 years at screening * hiv-1 seropositive * asymptomatic and in generally good health * no prior anti-retroviral therapy within 6 months of screening * viral load ≥ 3,000 ≤ 100,000 hiv-1 rna copies/ml * cd4+ t-cell count ≥ 400/mm3. exclusion criteria: * pregnant/nursing females * positive for hbv or hcv * acute herpetic event * any clinically significant out-of range laboratory value * subject is unable or unwilling to discontinue during the study * participation in another investigational drug/vaccine study within 30 days preceding the first injection of investigational agent in this study.

Keywords: hiv vaccine lipopeptide tat tuti-16 thymon treatment naive
investigation of potential mechanisms in stellate ganglion block in individuals with cerebral small vessel disease

Conditions: Cerebral Small Vessel Diseases

Summary: this is a prospective study conducted on patients with cerebral small vessel disease, dysphagia and cognitive impairment. they were divided into the comparison group and observation group evenly. all the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. the swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by penetration-aspiration scale, mini-mental state examination and modified barthel index.

this study is conducted for exploration of stellate ganglion block in patients with cerebral small vessel disease. this is a prospective study conducted on patients with cerebral small vessel disease, dysphagia and cognitive impairment. they were divided into the comparison group and observation group evenly. all the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. the swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by penetration-aspiration scale, mini-mental state examination and modified barthel index.

Eligibility criteria:
inclusion criteria: * age\>18 years. * meeting the diagnostic criteria for cerebral small vessel disease. * dysphagia confirmed by videofluoroscopic swallowing study * mini-mental state examination (mmse)\<27, indicating the existence of cognitive impairment. * no history of prior stroke. exclusion criteria: * dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc. * cognitive impairment that might be caused by other diseases, such as alzheimer's disease. * neurological blockade contraindications such as bleeding tendency, blocked site infection. * unable to successfully finish the assessment of this study. * complicated with severe liver and kidney failure, tumors, or hematological disorders. * simultaneously in need to undergo other therapy that might affect the outcomes of this study. * pregnant or nursing females
effect of ultrasound cavitation versus whole body vibration on abdominal fat in obese adolescent females

Conditions: Abdominal Obesity

Summary: this study aims to determine the differences between the effect of ultrasound cavitation and whole-body vibration on abdominal fat in obese adolescent females

adolescence is a critical time associated with the development of obesity. about 80% of adolescents with obesity will continue to have this condition as an adult. obesity during adolescence is associated with a number of short- and long-term diseases including hypertension, diabetes mellitus type 2, hyperlipidemia, obstructive sleep apnea, psychological distress and future cardiovascular complications. the investigators showed that there is an increasing demand for non-surgical procedures in the management of obesity that led to the development of non-invasive techniques for reducing localized subcutaneous adipose tissue. one of these techniques is focused ultrasound cavitation. research studies showed some benefits in the treatment of excess abdominal fat deposits with reduction in fat circumference without significant side effects. also, another non-invasive technique is whole body vibration (wbv). some studies showed that when it is combined with dietary intervention leads to body weight reduction and improvement of overall body composition and fat reduction including abdominal fat both ultrasound cavitation (uc) and whole-body vibration (wbv) are non-invasive modalities with many positive effects on abdominal fat in obese adolescent females. the effect of both the uc and wbv has been separately investigated in previous studies. though, no studies were found to compare the effect of both modalities in the management of abdominal fat in obese adolescent females. therefore, this study will be conducted to explore the effect of uc versus wbv on abdominal fat in obese adolescent females.

Eligibility criteria:
inclusion criteria: * adolescent females suffer from abdominal obesity. * their ages will be ranged from 17 to 25 years old. * their body mass index (bmi) will be ranged from 30 to 35 kg/m2. * their waist circumference will be \> 88 cm. * their whr will be more than 0.88. exclusion criteria: females will be excluded from the study if they have: * thyroid, hepatic and kidney disorders. * diabetes mellitus, coronary artery diseases, hypertension and congestive heart failure. * recent abdominal surgical scar or umbilical hernia. * history of orthopedic implants insertion or cardiac pacemaker implantation.
expectations about the covid-19 vaccines

Conditions: Vaccine Adverse Reaction

Summary: this study collects information on expectations and attitudes towards the covid-19 vaccines in participants about to receive a covid-19 vaccine. this information will be linked to data on side effect occurrence collected in an independent study.

general hypothesis: negative expectations and attitudes towards the vaccine are associated with a higher risk of side effects

Eligibility criteria:
inclusion criteria: * must have signed up to receive a covid-19 vaccine in denmark * participants are also a part of the enforce study from which outcome data is obtained * must be able to read and understand danish
effect of mk0524a on flushing caused by niacin (0524a-056)

Conditions: Flushing

Summary: the primary objective of the study is to assess the effects of mk0524a in reducing flushing associated with niacin.


Eligibility criteria:
inclusion criteria: * patient is male or female between 18 and 70 years of age * females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study exclusion criteria: * patient has a history of hypersensitivity to niacin or niacin-containing products * patient is currently experiencing menopausal hot flashes * patient consumes more than 2 alcoholic beverages per day * patient has poorly controlled type 1 or type 2 diabetes mellitus * patient engages in vigorous exercise or an aggressive diet regimen
ticagrelor and anti-inflammatory effects

Conditions: Chronic Kidney Disease

Summary: antiplatelet treatment in patients with end stage renal disease (esrd) on hemodialysis (hd) is still challenging because of bleeding and thrombotic complications. the investigators hypothesized ticagrelor once daily dose would achieve tolerable antiplatelet effects compared with ticagrelor twice a day dose in esrd patients on hd.

chronic kidney disease (ckd) is a strong risk factor for cardiovascular morbidity and mortality, and confers an increasing risk of stent thrombosis even when dual antiplatelet therapy (clopidogrel and aspirin) is administered. patients with severe ckd or end stage renal disease (esrd) on hemodialysis (hd) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. the investigators recently reported platelet inhibition by ticagrelor was faster and markedly greater than by clopidogrel with onset dosing regimen in patients with esrd on hd. however, few studies have been conducted whether platelet reactivity during ticagrelor treatment is associated with endothelial function, platelet activation markers and inflammation status in esrd patients on hd. additionally, the dose dependent effects of ticagrelor have been rarely evaluated.

Eligibility criteria:
inclusion criteria: * esrd patients undergoing regular (≥ 6 months) maintenance hd * ongoing (≥ 2 months) treatment with clopidogrel * p2y12 reaction units (prus) were more than 235 exclusion criteria: * known allergies to aspirin, clopidogrel, or ticagrelor * concomitant use of other antithrombotic drugs (oral anticoagulants, dipyridamole) * thrombocytopenia (platelet count \<100,000/mm3) * hematocrit \<25% * uncontrolled hyperglycemia (hemoglobin a1c \>10%) * liver disease (bilirubin level \>2 mg/dl) * symptomatic severe pulmonary disease * active bleeding or bleeding diathesis * gastrointestinal bleeding within the last 6 months * hemodynamic instability * acute coronary or cerebrovascular event within the last 3 months * pregnancy * any malignancy * concomitant use of a cytochrome p450 inhibitor or nonsteroidal anti-inflammatory drug * recent treatment (\<30 days) with a glycoprotein iib/iiia antagonist

Keywords: platelet ticagrelor clopidogrel end stage renal disease hemodialysis