Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of kui-yuan chewable tablets in patients with hyperuricemia

Conditions: Hyperuricemia

Summary: this study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. the aim of the study is to evaluate efficacy and safety of kui-yuan chewable tablets in patients with hyperuricemia.


Eligibility criteria:
inclusion criteria: * blood uric acid level\>7.0mg/dl (420 μmol/l) * the participants did not experience any acute gout attacks before treatment * the ecg of the participants was normal before treatment exclusion criteria: * secondary hyperuricemia caused by kidney disease, blood disease, or taking certain drugs, tumor radiotherapy and chemotherapy, organ transplantation, etc * those who have used allopurinol, probenecid, benzbromarone, febuxostat or traditional chinese medicine with uric acid lowering effect within 4 weeks before enrollment * those who had a history of cardiovascular and cerebrovascular diseases such as stroke, tia, mi, hf (nyha grade ii-iv), and coronary artery surgery (such as angioplasty, stent implantation, bypass grafting, etc.) * those who had a history of gastrointestinal ulcers or gastrointestinal bleeding * active liver disease or abnormal liver function, alt and ast are more than 3 times the upper limit of normal * glomerular filtration rate (egfr)\<30ml/min/1.73m2 * those who are allergic or intolerant to any component in kui-yuan chewable tablets and placebo * those who had other autoimmune diseases * those who are taking or need to take aspirin, other salicylic acids, heparin, dicoumarol and other anticoagulants and antiplatelet aggregation drugs * those who taking diuretic * those who had a history of alcohol or drug dependence, or those who require long-term daily use of painkillers for any reason * pregnancy, lactation, or planned pregnancy within 3 months after the last study medication

Keywords: hyperuricemia kui-yuan chewable randomized controlled trial
is inpatient rehabilitation effective for very old patients?

Conditions: Activity, Motor; Elderly Patients; Musculoskeletal Diseases

Summary: the goal of this retrospective longitudinal observational study is to compare the effects of physical and mental performance as well as quality of life in patients with neurological and musculoskeletal disorders. the main question it aims to answer is: do very old patients benefit in a similar way from inpatient rehabilitation like younger patients? data from about 2000 patients will be retrospectively analyzed. functional independence measurement (fim), timed up and go test (tug), euroqol 5 dimensions (eq-5d) and patient reported outcomes measurement information system (promis) were recorded on admission and discharge. researchers will compare the age group 75 to 84 and 85 to 99 to see if physical and mental performance as well as quality of life will improve.

inpatient rehabilitation has been shown to improve exercise capacity and quality of life in patients with neurological and musculoskeletal disorders. rehabilitation in valens includes intensive strength and endurance training. expectedly improvements in physical and mental performance measured by functional independence measurement (fim), timed up and go test (tug), euroqol 5 dimensions (eq-5d) and patient reported outcomes measurement information system (promis) is recognized after inpatient rehabilitation. but is this clinical effect in the same way represented in very old patients? to the knowledge of the investigators only few studies evaluated changes after rehabilitation in patients with neurological and musculoskeletal disorders in very old patients. therefore, the primary goal of this study is to evaluate changes in physical and mental performance in patients with neurological and musculoskeletal disorders after inpatient rehabilitation.

Eligibility criteria:
inclusion criteria: * german speaking * age \>74 * patients with neurological and musculoskeletal disorders exclusion criteria: * age \<75 * patients with pulmonological and internal disorders
postoperative pain results according to pressure to form pneumoperitoneum

Conditions: Cholecystitis; Postoperative Pain

Summary: this study showed the difference in postoperative pain between the groups that performed surgery with the low-pressure pneumoperitoneum and the group that performed surgery in the standard-pressure pneumoperitoneum when robotic single-hole cholecystectomy was performed. the primary purpose of the study was to compare the differences in the visual analog scale (vas) between the two groups and to demonstrate the effectiveness of pain relief after surgery. secondly, the effect of the low-pressure pneumoperitoneum on the patient's postoperative recovery and outcome was compared with the control group by comparing the length of stay, operation time, and postoperative complications.

laparoscopic cholecystectomy was the most common treatment method for gallbladder-related diseases, and robotic cholecystectomy was also currently being performed. many patients complained pain around the wound, shoulder and back after surgery. several methods had been attempted to reduce postoperative pain, previous studies showed that oral medications such as nsaids, administration of local anesthetics in wounds and abdominal cavity, low-pressure penumoperitoneum, humidification of intraperitoneal washing fluid, and active residual gas suction in the abdominal cavity had been found to relieve postoperative pain. robotic cholecystectomy, similar to laparoscopic cholecystectomy, also formed pneumoperitoneum to secure the surgical space during operation. based on the results published in various studies, it had known that the most effective method of pain relief for laparoscopic pain was to create low-pressure pneumoperitoneum. in this study, investigators attempted to prove the effectiveness of low pressure pneumoperioneum through a prospective randomized controlled trial between the experimental group with the low-pressure pneumoperitoneum and the control group with the standard-pressure pneumoperitoneum during robotic single-hole cholecystectomy.

Eligibility criteria:
inclusion criteria: patients who underwent elective gallbladder surgery * cholelithiasis * chronic cholecystitis * gallbladder polyps * gallbladder adenoma * porcelain gallbladder exclusion criteria: 1. acute cholecystitis patient group * necrotic gallbladder * collapsed gallbladder * gallbladder pustosis * gallbladder emphysema * hemorrhagic gallbladder * perforated gallbladder 2. cholecystitis with a gallbladder thickness of 4 mm or more on ct or ultrasound 3. cholecystitis with adhesions to surrounding organs due to inflammation of the gallbladder 4. patient group performing surgery concurrently due to other organ diseases 5. immunosuppressive patient group * transplant patient group: liver transplant patient group (pslt), kidney transplant patient group (pskt) * aids patients group 6. patient group with history of open abdominal surgery 7. transplant group during open surgery 8. patients under 19 years of age.

Keywords: robot cholecystectomy low-pressure pneumoperitoneum postoperative pain
pharmacokinetic study of oral testosterone (t) ester formulations in hypogonadal men

Conditions: Hypogonadism

Summary: the purpose of this pharmacokinetic study is to determine whether oral testosterone (t) ester formulations can be used effectively to treat men with low testosterone.

determination of the steady-state serum t pharmacokinetic profiles for two oral formulations of t-esters \[testosterone undecanoate (tu) and tu combined with testosterone enanthate (te)\] administered bis in die (bid) to 29 hypogonadal adult male subjects. tu was evaluated in total daily doses of 400 and 600 mg equivalents of t given twice daily for 7 or 8 days; tu + te was evaluated in total daily doses of 600 and 800 mg equivalents of t given twice daily for 7 days. all subjects were enrolled into a single group and proceeded through the four treatment periods 1-4 in a sequential manner. in treatment period 3 the effect of food on the study-state pharmacokinetics profile of the tu formulation was evaluated.

Eligibility criteria:
inclusion criteria: * male, ages 18-68 * serum total t less than or equal to 275 ng/dl exclusion criteria: * significant intercurrent disease of any type, in particular, liver, kidney or heart disease, uncontrolled diabetes mellitus or psychiatric illness. * abnormal prostate digital rectal examination, elevated prostate-specific antigen (psa), american urological association (aua) symptom score of \>15, and/or history of prostate cancer. * hematocrit of \ 50% * body mass index (bmi) \>36 * serum transaminases \> 2 times upper limit of normal or serum bilirubin \> 2.0 mg/dl

Keywords: testosterone male hypogonadism low testosterone
chorioamnionitis: observation of at risk infants vs standard care

Conditions: Chorioamnionitis; Early Onset Neonatal Sepsis; Sepsis of the Newborn

Summary: this study evaluates the non-inferiority of a protocol of limited evaluation (complete blood count, blood culture) and clinical observation by standardized physical examination versus the algorithm suggested in the cdc's 2010 guidelines (limited evaluation, clinical observation and antibiotic therapy) in the management of asymptomatic infants born at term to mothers with suspected chorioamnionitis. the primary outcome of the study is the difference in the prevalence of sepsis-related symptoms between the two groups.

chorioamnionitis complicates 1-3% of pregnancies at term. the current international guidelines of the center for disease control (cdc 2010) recommend that all asymptomatic newborns born to mothers with suspected chorioamnionitis undergo limited evaluation (i.e. blood culture at birth and complete blood count) and antibiotic therapy until the blood culture result is available. however, the prevalence of positive blood cultures in infants born to mothers with suspected chorioamnionitis is low, approximately 1%, including also infants requiring intensive care. this prevalence is even lower in asymptomatic infants. moreover, the efficacy of antibiotic prophylaxis in preventing early sepsis, death or long-term sequelae in asymptomatic infants born to mothers with suspected chorioamnionitis has not been demonstrated. early antibiotic use has been related to obesity and to the modification of microbiota. limiting antibiotic use may prevent the emergence of antibiotic-resistant bacteria. clinical observation is a reliable method to recognize infants with sepsis.

Eligibility criteria:
inclusion criteria: - asymptomatic newborns born at term (\>= 37 weeks of gestational age) exclusion criteria: * preterm newborns (\< 37 weeks gestational age) * sepsis-related signs of symptoms at birth * intensive care admittance

Keywords: chorioamnionitis early onset neonatal sepsis antibiotics clinical observation
effect of hyperbaric oxygen therapy

Conditions: Performance Enhancing Product Use; Physical Fitness; Recovery; Sport

Summary: the goal of this tudy will be to investigate the effects of a single session of hyperbaric oxygen therapy (hbot) on recovery and performance after a football match in elite youth football players. the main questions this study will aim to answer are: will a single session of hbot improve recovery parameters such as biochemical markers and physical fitness in elite youth football players after a football match? will a single session of hbot enhance the performance of elite youth football players after a football match? participants in this study will include twenty elite youth male football players. they will be randomly assigned to either the hbot group or the control group. all participants will undergo evaluations for biochemical parameters, physical fitness tests, and the hooper index (hi) at multiple time points: before the match, at the end of the match, one hour after the hbot session, and 12 hours after the hbot session. in the hbot group, participants will receive 100% oxygen under elevated pressure in a hyperbaric chamber for a duration of 70 minutes immediately after the football match. meanwhile, the control group will be exposed to normal atmospheric pressure. biochemical analysis will involve collecting blood samples to measure markers such as myoglobin, creatine kinase, lactate dehydrogenase, alanine aminotransferase, and aspartate aminotransferase. physical fitness tests will include vertical jump height measurements (squat jump, countermovement jump, and countermovement jump with arm swing) and linear speed assessments at various distances (5 m, 10 m, and 20 m). the hooper index (hi) will be used for subjective assessment of fatigue and well-being. this study aims to provide insights into the potential benefits of hbot as a recovery strategy for elite youth football players and its impact on performance in the future.


Eligibility criteria:
inclusion criteria: * football player * free of injuries * free of medical conditions contraindicated by hyperbaric oxygen therapy (hbot) * written parental consent exclusion criteria: * pre-existing injuries or medical conditions that are contraindicated by hyperbaric oxygen therapy (hbot) * participation in severe physical activity within 24 hours before the study * participants who do not comply with the requirement to abstain from breakfast, caffeine, and alcohol prior to the first blood collection * an active respiratory illness, such as a cold, at the time of the study

Keywords: hyperbaric chamber football recovery hyperbaric oxygen therapy performance fatigue
validation of a clinical screening grid for syndromic schizophrenia

Conditions: Schizophrenia

Summary: background: nowadays, despite a large number of studies about schizophrenia and genetics, clinical red flags for syndromic forms of schizophrenia remain poorly documented.

methods: this study aims to validate a short clinical screening grid for syndromic forms of schizophrenia linked to a pathogenic copy variation number (cnv). the investigators plan to include 150 patients with defined (dsm v) schizophrenia and aged 15 years and more. the clinical grid will be prospectively fulfilled for every patients on the basis of his/her medical history and clinical examination. array comparative genomic hybridization (cgh-a) will be performed on jugal mucosae sample to detect precisely syndromic forms of schizophrenia linked to the presence of a pathogenic copy number variation (cnv). in subjects with no cnv that may explain the onset of schizophrenia, the investigators would like to complete the investigations with exome trio sequencing. with this type of very clinical approach, the investigators wish to determine which semiological elements should alert the psychiatrists as to the presence of a syndromic form. the objective is to propose at the end of this study a simple and reliable scale, usable in psychiatry consultation, to guide the genetic screening of forms of syndromic schizophrenia.

Eligibility criteria:
inclusion criteria: * patient aged 15 years and more with a schizophrenia defined by the dsm v criterion * informed consent signed by the patient or he/she's legal representant exclusion criteria: * pregnancy * current psychotic decompensation * patient with a known genetic syndrome
ultrasound guided emergency physician performed erector spinae nerve block for rib fracture analgesia

Conditions: Rib Fractures

Summary: the study will be a prospective randomized double blinded placebo controlled clinical trial using ultrasound guided erector spinae plane block as an analgesic adjunct among adult emergency department (ed) patients with rib fractures using mean morphine milligram equivalents as the primary outcome.

aim 1: given the novelty of the erector spinae plane nerve block and limited data from anesthesia literature, aim 1 is to obtain preliminary data regarding quantity of mean morphine equivalents received by control and experimental groups for an initial subset of 50 patients to improve sample size calculation and better power the study. aim 2: evaluate efficacy of ed performed ultrasound guided esp block in delivering analgesia by evaluating difference in morphine milligram equivalents (mme) as well as pain scores during ed stay and hospital admission between the experimental and control groups. aim 3: evaluate adverse event rates related to ultrasound guided esp block placement as well as rates of rib-fracture related complications between control and experimental groups.

Eligibility criteria:
inclusion criteria: 1. radiographic evidence of unilateral rib fracture(s). 2. able to consent and actively participate in the study. 3. moderate to severe pain (defined as numerical pain rating score \>/ 4 ) at time of enrollment. exclusion criteria: 1. known allergy or hypersensitivity to local anesthetics or morphine. 2. infection at site of esp block placement. 3. depth over 5 cm from skin to transverse process visualized with ultrasound. 4. additional injuries that preclude positioning for esp block placement. 5. severe traumatic brain or spinal cord injury. 6. severe altered mental status, such that pain could not be assessed. 7. extra thoracic injuries for which rib pain is reported as less than the rest of the injuries. 8. adjunctive epidural catheter pain control. 9. other regional anesthetic blocks. 10. pregnancy or prisoner status. 11. unstable vital signs.
developing metagenomic approaches to identify the causes of pediatric infectious diseases

Conditions: Infectious Disease

Summary: infectious diseases remain leading causes of mortality and morbidity in children. rapid and accurate diagnosis of infectious diseases in children is important for developing an effective treatment and management strategy. however, the current diagnosis of infectious agents mainly depends on culture and molecular testing. both of the methods either has long turnaround times or narrow detection range. metagenome next generation sequencing (mngs) has been applied to the diagnosis of central nervous system infection, lower respiratory tract infection and sepsis, which showed high positive rate, short turnaround time. however, there is currently no assessment of the diagnostic efficacy of mngs in children infectious diseases. this study used the dna extraction and library construction technology developed for children's low volume clinical samples to assess the sensitivity and specificity of mngs in the diagnosis of infectious diseases, and the treatment outcome based on mngs test results.


Eligibility criteria:
inclusion criteria: * patients are highly suspected of sepsis； * patients are highly suspected of respiratory infections； * patients are highly suspected of central nervous system infection； * patients are highly suspected of fever of unknown origin exclusion criteria: * congenital malformations； * patients requiring surgical intervention; * patients with skin barrier dysfunction

Keywords: metagenome next generation sequencing pediatric
long-term follow-up study of subjects treated with actr t cell product

Conditions: B Cell Lymphomas; Multiple Myeloma; Solid Tumor; HER-2 Protein Overexpression

Summary: subjects treated with an actr product may participate in this long-term follow-up study after the completion of the final scheduled visit in the parent clinical study or other investigational setting, such as compassionate use, named patient investigational new drug application, expanded access program, or equivalent setting. no investigational product or treatment will be administered in this study. these subjects will be followed for safety monitoring on a schedule of decreasing frequency through 15 years post-actr treatment, in accordance with us fda regulatory guidance pertaining to long-term safety follow-up for study subjects receiving recombinant dna-containing investigational products.


Eligibility criteria:
inclusion criteria * willing to provide informed consent for participation in the study * received at least 1 dose of an actr t cell product in an investigational or other treatment setting, such as compassionate use, named patient ind, expanded access program, or equivalent settings * has completed study assessments and follow-up visits in the prior study or other investigational setting to the extent willing and able to do so * able to comply with study requirements exclusion criteria * none
brief treatment for trauma nightmares in trauma-exposed adults with bipolar disorder

Conditions: Nightmares; Post-traumatic Stress Disorder

Summary: exposure, relaxation, and rescripting therapy (errt) is a promising psychological intervention developed to target trauma-related nightmares and sleep disturbances. though further evidence is needed, errt has shown strong support in reducing the number and intensity of nightmares, as well as improving overall sleep quality in both civilian and veteran samples. this study will assess the efficacy in individuals diagnosed with bipolar disorder.

this pilot study will examine the efficacy of exposure, relaxation, \& rescripting therapy (errt) on chronic nightmares in trauma-exposed adults diagnosed with bipolar disorder (b-errt), as these individuals have been excluded from past clinical trials. eligible participants will be assessed prior to starting treatment. b-errt will be conducted once a week for approximately five consecutive weeks for approximately two hours per session. each treatment session focuses on one of the following topics/skills: psychoeducation regarding trauma, nightmares, and sleep disturbances on bipolar disorder, relaxation techniques, exposure to the trauma-nightmare, and relapse prevention. participants will then be asked to complete two to three follow-up assessments, 1-week, 3-months, and potentially 1-year after the end of the treatment.

Eligibility criteria:
inclusion criteria: * nightmares at least once per week for the past month * formal diagnosis of bipolar disorder (i or ii) * exposure to traumatic event (1+ months ago) * stable on bipolar medication for at least 2 months exclusion criteria: * a traumatic event within the last month * intellectual disability * current or recent mania/hypomania within the last 3 months * suicide attempt or hospitalization within the last 3 months * current or untreated substance use disorder within the past 6 months

Keywords: nightmares sleep ptsd exposure, relaxation, and rescripting therapy
scribes in the emergency department

Conditions: Scribes in the Emergency Department

Summary: this study will evaluate the effect of scribes on an academic emergency department.

this study will be a prospective before-after study with washout period of various performance measures before and after the implementation of ed scribes. we will also collect survey data to measure physician satisfaction and patient perception of scribes.

Eligibility criteria:
inclusion criteria: * all consecutive patients during the study period * age \> 18 y/o exclusion criteria: * patients seen during the washout period

Keywords: scribes physician productivity electronic documentation
tenofovir monotherapy in patients with chronic hepatitis b patients who had achieved complete viral suppression on entecavir plus tenofovir

Conditions: Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48

Summary: little is known about efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic ehpatitis b patients who achieved a complete virological response to entecavir and tenofovir. this study aimed to investigate the efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic hepatitis b patients with undetectable heaptitis b virus dna while on tenofovir plus entecavir combination therapy.


Eligibility criteria:
inclusion criteria: * hbsag (+) for \> 6 months age \>19 years antiviral resistance to lam(rtl180m and/or m204v/i) \& adv (rta181v/t and/or rtn236t) or etv (rtt184a/c/f/g/i/l/s, rts202g, or rtm250l/v, in addition to rtm204v/i) hbv dna levels \<20 iu/ml on two consecutive tests of 3-month interval currently receiving tdf+etv for more than 12 months exclusion criteria: * cr ≥1.5 mg/dl evidence of decompensated liver disease malignant neoplasm coinfection with hiv, hcv