Kornimate/medical-research-clean huggingface dataset:
registration of the study of reyanning mixture

Conditions: Acute Tonsillitis

Summary: the purpose of this study is to evaluate the efficacy and safety of treating with acute tonsillitis using reyanning mixture alone/in combination with antibiotics, and its function of reducing the use of antibiotics.

in order to evaluate the efficacy,safety and the function of reducing the use of antibiotics of reyanning mixture (a mixture of chinese herbal medicine) in treating with acute tonsillitis, a randomized, double-blind, placebo-controlled, multicenter clinical trials will be established. according to the relevant regulations of the china food and drug administration(cfda), 144 cases need to be registered at least. the aim population is who suffering of acute tonsillitis from october 2018 to december 2019.these cases will be randomly divided into treatment group 1(reyanning mixture +amoxil capsule simulator),treatment group 2(reyanning mixture +amoxil capsule) and control group(reyanning mixture simulator +amoxil capsule).each group will be treated for 7 days and followed up for 3 times . the main indicators include the recovery time/rate and antibiotic duration/dosage. and the vanish rate of single symptom/physical sign, the ratio of white blood cell count(wbc) recovery, the time of fever will be observed as well.

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria of acute tonsillitis; 2. meet the traditional chinese medicine symptom diagnostic criteria of external wind-heat type and excessive heat in the lung and stomach type; 3. 18 years≤age≤65 years; 4. course of disease within 72 hours; 5. sign informed consent. exclusion criteria: 1. common cold,influenza, acute laryngopharyngitis, pharyngeal diphtheria, wensang's isthmitis. 2. complicated with acute tracheobronchitis,pneumonia,rheumatic fever, acute glomerulonephritis or rheumatic heart disease. 3. complicated with severe angiocardiopathy, cerebrovascular disease, hemopoietic system disease or psychopath. 4. liver or kidney function is abnormal(alt\>1.5 times upper limit of normal; cr\>upper limit of normal); diabetic. 5. wbc\<10×109/l and neutrophilic granulocyte percentage\<75%;or wbc ≥20×109/l; 6. gestational, lactating women or who planning to get pregnant within half a year. 7. already accept similar traditional chinese medicine or antibiotic within 48 hours before registered. 8. joining other clinical trials or allergic to any drug in this trials.

Keywords: reyanning mixture efficacy safety randomized double-blind placebo-controlled multicenter antibiotics
a placebo-controlled study of physiologic effects of l-methylfolate in schizophrenia patients

Conditions: Schizophrenia

Summary: this study is a 12-week, double-blind, placebo-controlled trial of l-methylfolate 15 mg/d supplementation in schizophrenia patients with mild or greater negative symptoms. l-methylfolate, a prescription medical food, is the activated form of folate required for conversion of homocysteine to methionine and hence is the optimal form of folate for supplementation, since it eliminates the need for activation by mthfr. the purpose of this study is to examine the change in plasma l-methylfolate concentrations following a three-month trial of l-methylfolate 15 mg/d compared to placebo.

blood levels of l-methylfolate and biological activity will be evaluated by examining changes in plasma homocysteine concentrations, serum methionine concentrations and changes in brain activation as measured by fmri.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia, any subtype * male of female * age 18-68 years * treated with an antipsychotic for at least 6 months at a stable dose for at least 6 weeks * panss total score of at least 60, with at least 3 (moderate) on one negative symptom item or on one positive symptom item * simpson angus scale (sas) for the eps total score of 12 or less and * a score of 2 (mild) or less on all items of the calgary depression rating scale (cdrs) * comprehension of english adequate to complete cognitive testing exclusion criteria: * unable to provide informed consent * cbc results consistent with megaloblastic anemia * serum creatinine concentration greater than 1.4 * current use of folate supplementation \> 400mcg folate * alcohol or other substance abuse within 3 months (nicotine allowed) * current use of any of the following medications: phenobarbital, phenytoin, carbamazepine, valproic acid, fosphenytoin, primidone or pyrimethamine * positive baseline urine toxic screen, (positive test for pcp, barbiturates, cannabinoids, amphetamines, benzodiazepines, opiates, or cocaine) * unstable medical illness (exclusionary lab values are listed in appendix a) * unstable psychiatric illness * seizure disorder * pregnant or nursing, or planning/trying to get pregnant within the next 6 months, and * dsm-iv diagnosis of major depressive disorder

Keywords: l-methylfolate deplin schizophrenia folate folic acid homocysteine methionine mthfr genotype c677t mutation vitamin b6 vitamin b12 psychotic symptoms mthfr c677t polymorphism
sleep disordered breathing in precapillary pulmonary hypertension: effect of cpap treatment

Conditions: Sleep-Disordered Breathing; Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Summary: evaluation of the effect of cpap (continuous positive airway pressure ) treatment in pah (pulmonary arterial hypertension) and cteph (chronic thromboembolic pulmonary hypertension) patients suffering from sleep disordered breathing.

the primary endpoint of the study is to evaluate the effect of cpap therapy on pulmonary vascular resistance in pah and cteph patients suffering from sleep disordered breathing. the secondary endpoints are the effect of cpap on right atrium and right ventricle diameter and ejection fraction measured by echocardiography, 6 minutes walk distance, nyha class, qol, endothelial function, sympathetic activity and prognosis.

Eligibility criteria:
inclusion criteria: * minimum 18 years old * diagnosed with pah or non-operable cteph or operated cteph with peristent pulmonary hypertension * diagnosis of pah based on cardiac catherisation * diagnosis of cteph confirmed by contrast-enhanced spiral chest ct, pulmonary angiography and v/q scintigraphy * recent diagnosis of sleep disordered breathing (polysomnography realized within 3 months before inclusion showing ahi above 15) stable clinical condition for at least 3 months before inclusion as defined by nyha and a walking distance difference within 10% of the previous 3 months and no change in medical therapy during this 3 months exclusion criteria: * congenital heart disease * moderate and severe restrictive or obstructive pulmonary disease with a tlc and a fev1\<60% of the predicted value * bmi 35kg/m2 or more * patients already treated with cpap * patients with severe sleepiness (epworth sleepiness scale from 18 to 24/24)
evaluation of a fast-track knee arthroplasty concept

Conditions: Knee Arthropathy; Postoperative Pain; Postoperative Complications

Summary: mobilisation following knee arthroplasty is an important aspect to achieve early and enhanced recovery after surgery and sufficient joint function. analgesia is a crucial therapeutic element in this context. this rct evaluates two analgetic regimens for patients undergoing primary total knee-replacement to assess impact on postoperative recovery.

mobilisation following knee arthroplasty is important for patients to achieve early and enhanced recovery after surgery and sufficient joint function. analgesia is a crucial therapeutic element in this context. there is evidence that regional- anaesthesiological catheter techniques are very efficient to control pain postoperatively. on the other hand, motoric function may be reduced due to nerve blocks depending on location and concentration of drug used. local infiltration of the knee during surgery is an alternative component in pain management that may reduce impaired motor function and allow early mobilisation of patients. however, currently it is not known which analgesia technique provides optimal pain control paralleled with sufficient motor function. against this background, this rct evaluates two analgesia regimens for patients undergoing primary total knee-replacement to assess impact on postoperative recovery.

Eligibility criteria:
inclusion criteria: * patients undergoing elective, primary knee joint replacement in combined general anaesthesia exclusion criteria: * heart insufficiency nyha \>2 * liver insufficiency \> child b * evidence of diabetic polyneuropathy * severe adipositas bmi \>40 * patients \< 18 years * pregnancy * in case of police custody * participation in a paralleled interventional rct in a time frame of 30 days * chronic opioid therapy \>3 months before scheduled surgery * allergy against medication required for surgery or anaesthesia

Keywords: eras pain knee arthroplasty joint pain regional anaesthesia
weight bearing status post-hip arthroscopy

Conditions: Hip Impingement Syndrome; Acetabular Labral Tear

Summary: this study is being proposed to examine weight bearing precautions following hip arthroscopic labral repair, femoroplasty, and capsular closure. standard post operative protocols limit weight bearing for 2-6 weeks depending on individual surgeons. cadaveric studies demonstrate that minimal force during weight bearing is distributed through labrum. therefore, progressing weight bearing earlier in these patients post operatively may help progress faster and improve outcomes. data collected will include demographic information, radiological data, operative procedures and pro data.

the study will be conducted at upmc st. margaret's hip preservation program. consented patients who undergo acetabular labral repair and femoroplasty will be included in randomization of weight-bearing status. two separate protocols will be created to indicate weight bearing status, either wbat immediately post-op or ffwb immediately post-op, to distribute to rehabilitation staff to ensure compliance. immediately after the surgical procedure, the surgeon will be blinded and a randomized pamphlet with post-operative instructions with weight bearing education will be given to pacu nursing staff to educate patients and fit crutches.

Eligibility criteria:
inclusion criteria: * age\>= 12 years * diagnoses: femoroacetabular impingement and hip labral tears. * surgical procedures performed: hip arthroscopy with femoroplasty and labral repair. * surgery completed at upmc children's or upmc st. margaret's hospital * unilateral and bilateral hip patients exclusion criteria: * msk tumor-related fai or dysplasia * generalized hypermobility * revision surgeries
the impact of anterior abdominal wall tissue oxygenation during pneumoperitoneum of regional anesthesia methods

Conditions: Laparoscopy; Abdominal Wall; Regional Anesthesia

Summary: during laparoscopic surgery, the abdomen is inflated with carbon dioxide for abdominal imaging and increased intraabdominal pressure affects intraabdominal structures and abdominal wall.

the investigators aimed to investigate the effects of regional anesthesia methods administered during laparoscopic cholecystectomy on abdominal wall oxygenation and postoperative pain scores.

Eligibility criteria:
inclusion criteria: * patients who were in the american society of anesthesiologists (asa) i-iii class * underwent laparoscopic cholecystectomy exclusion criteria: * previous surgeon surgeon * local anesthetic allergy, * bleeding is a diathesis disorder * mental impairment, * allergic to the drugs used, * patients who are not reluctant to participate in the study, * presence of infection in the block area, * patients whose body mass index is over 30
the effect of aging and immobilisation on muscle

Conditions: Healthy

Summary: the debilitating effects of immobilisation on muscle strength and size in young individuals are well documented. moreover, sarcopenia has long been recognized as a major cause of muscle strength loss in old age, however, changes in muscle mass and architecture with immobilisation in the elderly has not previously been investigated. this is contrasted by the fact that the elderly population more often undergoes periods of immobilization and disuse not only due to joint pain but also due to a higher degree of co morbidity and hospitalisation.the purpose of the present study was to compare the effect of a 2 week period of unilateral immobilisation on the physiological muscle cross sectional area, maximal isometric muscle strength, specific force, muscle fascicle length and muscle fibre pennation angle in young and old healthy men.


Eligibility criteria:
inclusion criteria: * young healthy males (age 20-30 yrs)or old healthy males (age 60-80 yrs) exclusion criteria: * musculoskeletal disorder * diabetes * cardiovascular disease * neurological diseases; or * cognitive disorders

Keywords: immobilisation aging resistance training atrophy the effect of immobilisation in elderly compared to young individuals
impact of formulary coverage of entresto (sacubitril/valsartan) on prescription abandonment/rejection and subsequent treatment and economic outcomes in chronic heart failure patients in the u.s.

Conditions: Chronic Heart Failure

Summary: this was a retrospective cohort study utilizing iqvia open-source pharmacy and medical claims data among patients with a sacubitril/valsartan (sac/val) prescription transaction.


Eligibility criteria:
inclusion criteria: primary iqvia longitudinal access and adjudication data (laad) cohort (for primary objective) * patients with ≥1 transaction for sac/val in laad between 01 january 2017 and 30 november 2019 (index period). date of the 1st sac/val prescription transaction during this period was the index date. * patients from the novartis-provided list of 21 plans and formularies of interest (mapping to laad data was based data elements such as plan name, payer name, and pharmacy benefit manager \[pbm\] name) as of the index date. * patients aged ≥18 years on the index date. * patients with 12-months of data visibility pre-index. * patients with 3-months of data visibility post-index (to allow for final adjudication/abandonment status confirmation). for comorbidity data only: * patients with linkage of laad fia to laad dx by patient id. * patients with ≥2 non-ancillary medical claims ≥30 days apart within the 12 months pre-index period. secondary laad cohort (for secondary objective) * among patients from the primary laad cohort remaining in step 6, patients who abandoned their 1st sac/val prescription or did not receive sac/val due to claim rejection in laad between 01 january 2017 and 28 february 2019 (index period). date of the 1st abandoned/rejected sac/val prescription transaction during this period is the index date. * patients aged ≥18 years on the index date. * patients with 12-months of data visibility pre-index. * patients with 12-months of data visibility post-index. * for comorbidity data only: * patients with linkage of laad fia to laad dx by patient id. * patients with ≥2 non-ancillary medical claims ≥30 days apart within the 12 months pre-index period. exclusion criteria: * patients with a sac/val transaction during the 12-month pre-index period. * patients with data quality issues (e.g., missing gender).
evaluation and treatment of patients with dermatologic diseases

Conditions: Dermatologic Diseases; Systemic Diseases With Cutaneous Manifestations

Summary: this is a training, natural history of disease, and screening protocol for the evaluation, treatment and follow-up of patients with dermatologic diseases and systemic diseases with cutaneous manifestations. patients enrolled in this protocol will be evaluated and treated according to generally available, standard procedures and therapeutic modalities. samples of blood and skin will be studied by routine and specialized investigative methods to establish these patients' diagnosis, response to treatment, and/or disease progression.

background this is a training, natural history of disease, and screening protocol for the evaluation, treatment and follow-up of patients with dermatologic diseases and systemic diseases with cutaneous manifestations. this protocol was developed to allow subject enrollment for teaching purposes and to allow for second opinions regarding relatively complicated patients, and to allow for evaluation of non-invasive tools for the diagnosis and monitoring of cutaneous manifestations. this protocol promotes a critical link between the nci, ccr dermatology branch and the local and national extramural medical communities. objectives: * to provide clinical material to fulfill the educational mission of the dermatology branch. * to learn about the natural history of selected dermatologic diseases. eligibility: all subjects regardless of age, gender, or racial/ethnic group with dermatologic disease or systemic disease with cutaneous manifestations. design: patients enrolled in this protocol will be evaluated and treated according to generally available, standard procedures and therapeutic modalities. samples of blood and skin will be studied by routine and specialized investigative methods to establish these patients diagnosis, response to treatment, and/or disease progression. non-invasive tools may be used as part of the examination and assessment of cutaneous manifestations of disease.

Eligibility criteria:
* inclusion criteria: patients of any age (only viable neonates will enroll in the study), of both genders, and all racial/ethnic groups with dermatologic diseases or systemic diseases with cutaneous manifestations that will help the branch fulfill the objectives. women who are pregnant or lactating, will only undergo tests and procedures, and/or receive medications for which data exists proving minimal risk to the fetus and/or child. patients must have a referring physician who will continue to assume primary medical responsibility of care for the patient during and after enrollment in this protocol. exclusion criteria: any participant who, in the investigator s opinion, would be unable to comply with study requirements or for whom participation may pose a greater medical risk.

Keywords: training standard therapy standard tests natural history consultation
docetaxel with or without metronomic cyclophosphamide as first line chemotherapy in metastatic breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the role of metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.

metronomic chemotherapy has been considered as an effective strategy for metastatic breast cancer. this trial is designed to evaluate the role of metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.

Eligibility criteria:
inclusion criteria: 1. females with age between 18 and 70 years old 2. ecog performance between 0-1 3. life expectancy more than 3 months 4. histological proven unresectable recurrent or advanced breast cancer 5. no previous chemotherapy for metastatic breast cancer;suitable for monotherapy (neoadjuvant or adjuvant docetaxel should be completed at least one year). 6. at least one measurable disease according to the response evaluation criteria in solid tumor (recist1.1) 7. no anticancer therapy within 4 weeks 8. adequate hematologic, hepatic, and renal function,no serious medical history of heart, lung, liver and kidney 9. provision of written informed consent prior to any study specific procedures exclusion criteria: 1. pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound) 2. women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study 3. treatment with an investigational product within 4 weeks before the first treatment 4. symptomatic central nervous system metastases 5. other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia. 6. patient having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions 7. uncontrolled serious infection 8. patients with bad compliance

Keywords: metronomic cyclophosphamide metastatic breast cancer first line docetaxel
racial inequality in inhaler fills for copd - a trial of reduced cost-sharing

Conditions: Chronic Obstructive Pulmonary Disease

Summary: in partnership with a large medicare advantage (ma) insurer (humana, inc.) and as part of a center for medicare and medicaid innovation demonstration program of value-based insurance design (vbid), the investigators propose to study a randomized controlled quality improvement trial in which humana randomized ma beneficiaries with copd to receive proactive outreach for a vbid benefit that provided large reductions in cost-sharing for their maintenance inhalers and telephone-based copd medication management services in 2020 and 2021. the investigators will analyze changes in racial disparities for inhaler fills, clinical outcomes, health care spending, and acute care utilization.


Eligibility criteria:
inclusion criteria: * has copd diagnosis * receives health services and prescription drug benefits through a humana medicare advantage plan that includes part d coverage * has at least one prior fill of a copd maintenance inhaler in the prior 12 months * not fully adherent to maintenance inhaler (pdc \< 80%) in year prior to randomization exclusion criteria: * enrolled in part d low-income subsidy program * on hospice * has end-stage renal disease * has mild copd (i.e., copd diagnosis but no maintenance inhaler fill, no pulmonary function tests in year prior year, and no acute care use for copd) * enrolled in humana plan for less than 3 months * in the coverage gap phase of ma plan at time of assignment * receives primary care at select locations of humana subsidiaries (centerwell or conviva)

Keywords: cost sharing health insurance inhalers adherence disparities