Kornimate/medical-research-clean huggingface dataset:
a phase iv study of huazhi rougan granule

Conditions: A Phase IV Trial to Investigate the Efficacy and Safety of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver

Summary: a placebo control, randomized, double-blind, multicenter phase iv study to investigate the efficacy and safety of huazhi rougan granule in the treatment of non-alcoholic simple fatty liver (damp-heat obstruction syndrome: shi-re-zhong-zu zheng)


Eligibility criteria:
inclusion criteria: * ≥18 and≤65 years old; * those who meet the diagnostic criteria of non-alcoholic simple fatty liver and traditional chinese medicine syndrome classification of damp-heat obstruction syndrome; * liver-to-spleen ct ratio ≤ 0.8; the imaging findings of liver were consistent with the diagnostic criteria of diffuse fatty liver; ④ voluntarily sign informed consent. the legal representative can sign informed consent on behalf of the patient who are unable to sign； ⑤ fpg≤7.0mmol/l 、hba1c≤6.5%；alt、ast、tbil≤2×uln. exclusion criteria: * fatty liver caused by chronic heart failure, malnutrition and pregnancy, encephalopathy fatty liver syndrome (reye syndrome), b-lipoprotein deficiency, localized fatty liver; fatty liver caused by diabetes, long-term use of hormones, enteritis, gastrointestinal postoperative chronic infection, etc.; small intestinal bypass surgery, hepatocyte toxicity injury, chronic febrile diseases such as tuberculosis, ulcerative nodules;； * severe fatty liver with ascites, edema, hyponatremia, hypokalemia and other suspected cirrhosis; hepatitis or cirrhosis caused by viruses, drug poisoning, immune diseases and other factors;； * those who had used any chinese or western drugs for the treatment of simple fatty liver within one month before randomization； * pregnant or lactating women, women of childbearing age who do not take effective contraceptive measures (such as condoms, hormonal contraceptives, intrauterine devices) or male subjects who do not want to use contraception;； * patients with serious primary cardiovascular diseases, liver diseases, kidney diseases, hematological diseases, lung diseases, tumors, aids and other serious diseases that affect survival. for example: abnormal kidney function: creatinine higher than the upper limit of normal; abnormal liver function: γ-gt\>200u/l or alt \>2×uln or ast\>2×uln; a clinically significant arrhythmia； ⑥ according to the 2010 guidelines for the prevention and treatment of dyslipidemia, patients with dyslipidemia requiring lipid-lowering drugs intervention：tc≥6.99mmol/l（270mg/dl）or ldl-c≥4.92mmol/l（190mg/dl）； ⑦ persons without or with limited capacity for civil conduct； ⑧ those who has suspected or confirmed history of alcohol abuse (alcohol equivalent male≥40g/d, female ≥20g/d) or drug abuse； ⑨ allergic to the components of this drug； ⑩ those who participated in other clinical investigators within 3 months prior to screening； ⑪ the investigators consider she/he inappropriate to participate in this study。
peng block plus lateral femoral cutaneous nerve block for posterolateral-approached total hip arthroplasty

Conditions: Pain; Postoperative Pain; Acute Pain; Analgesia; Hip Arthropathy; Postoperative Complications

Summary: this study aims to analyze the effect of pericapsular nerve group (peng) block combined with lateral femoral cutaneous nerve block vs. peng block combined with wound infiltration for analgesia after elective hip replacement performed with a posters-lateral approach. half of participants will receive a peng block combined with femoral lateral cutaneous nerve block, while the other half will receive peng block combined with wound infiltration


Eligibility criteria:
inclusion criteria: * elective hip replacement surgery performed with a poster-lateral approach * asa physical status score \< 4 exclusion criteria: * contraindications to regional anesthesia * asa physical status score ≥ 4 * patient's refusal or inability to sign the informed consent * allergies to any drug provided by the study protocol
sglt-2 inhibitor effects on cardiac and hepatic metabolic profiles for the diabetes patients combined with obesity

Conditions: Fatty Liver Disease

Summary: obesity is closely associated with an increased risk of cardiomyopathy because of the high metabolic activity of excessive fat while effective treatment of obesity-related cardiomyopathy is currently unsolved. sodium-glucose cotransporter-2 inhibitors (sglt2-i) are a class of diabetic medications. besides improving glucose control, sglt2-i has been shown to be able to reduce the bodyweight as well as the mortality and hospitalization rates for heart failure and cardiovascular disease in the type 2 diabetes patients. it has been proposed that the heart protection by sglt2-i might be caused by modulating the production of adipokine and cytokine. the investigators will enrolled 40 patients (diabetes mellitus with bmi\>27 kg/m2) from obesity weight-reduction clinics: 1) 20 patients treated with sglt2-i (cana) and regular weight-reduction plan; 2) 20 patients with regular weight reduction plan, without cana, for 4 weeks. the investigators will compare the variation of fibroblast growth factor-21 (fgf21) related proteins and rna between these 2 groups of subjects. the investigators will arrange cardiac ultrasound, hepatic mri and fibroscan, body composition dual energy x-ray absorptiometry to evaluate the possible mechanisms underlying the liver and heart modification process, as a scientific basis for precision medicine in the future. conclusions: sglt2-i treatment may increase the concentration of fgf21, either in the liver or heart, thus to protect the high-fat diet induced obesity associated heart dysfunction by activating fgf21 downstream protein expression.

the investigators will enrolled 40 diabetes mellitus with bmi\>27 kg/m2 patients from obesity weight-reduction clinics and will compare the variation of fgf21 related proteins between these 2 groups of subjects. serial examinations will evaluate the possible mechanisms underlying the protective mechanism. this investigation expect that sglt2-inhibitor can increase the concentration of fgf21 in the heart by increasing fgf21 in the liver, thereby modifying associated protein expressions and ultimately improving cardiac function and patient outcomes.

Eligibility criteria:
inclusion criteria: 1. age\> 20 years of age 2. with diagnosis of diabetic mellitus (hba1c≧6.5%) by medical record or physicians 3. bmi ≧ 27 kg/m2, which is the current definition of obesity from health promotion administration, ministry of health and welfare. exclusion criteria: 1. unwilling to participating current clinical trial 2. cannot tolerate sglt2-i therapy 3. not willing to join the study 4. history of failure treatment experience from sglt2-i or other weight reduction plan 5. received pharmaceutical or clinical trials within past 1 year

Keywords: fatty liver diabetes mellitus sglt2 inhibitor
study of performance of confocal endomicroscope with fluorescein imaging agent in the colon

Conditions: Colonic Dysplasia; Adenomatous Polyps; Irritable Bowel Disease

Summary: the overall aim of this research project is to evaluate the imaging performance of a confocal endomicroscope. fluorescein, an fda-approved topical fluorescent dye, will be used to provide topical mucosal contrast. the purpose of this instrument is to provide real-time endoscopic "histology" to guide endoscopic biopsy or endoscopic mucosal resection (emr) in the patient study group. this endomicroscope probe will be used during colonoscopies in subjects with colonic dysplasia, known colonic adenomatous polyps scheduled for endoscopic resection, or suspected dysplasia in subjects with inflammatory bowel disease (ibd).

the device is being tested in small groups of individuals: generally less than 10 for each of a variety of histologically different colonic lesions or diseases (eg. ibd, adenomas, sessile seriated adenomas (ssas), hyperplastic polyps, normal tissue).

Eligibility criteria:
inclusion criteria: subject meets at least one of the following criteria: * at increased risk for colorectal cancer and colonic polyps * known colonic adenomas scheduled for colonic polyp resection * scheduled for outpatient colonoscopy for follow up surveillance of ibd with known dysplasia or who are at high risk for high grade dysplasia. exclusion criteria: subject meets all of the following criteria: * subject is scheduled for outpatient colonoscopy in the medical procedures unit at university of michigan health system. * subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) standard practice guidelines for safely proceeding with the procedure will be sufficient for our study. * age 18 to 100 years * willing and able to sign informed consent
behavioral activation and medication optimization for improving perioperative mental health in older adults undergoing oncologic surgery

Conditions: Older Adults; Anxiety; Depression; Major Surgical Resection of a Thoracic Malignancy; Major Surgical Resection of an Abdominal Malignancy

Summary: using a hybrid type 1 effectiveness-implementation randomized control trial (rct) design, the investigators will test the effectiveness of a bundled behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing oncologic surgery (compared with usual care), while examining implementation outcomes.


Eligibility criteria:
inclusion criteria: pre-screening: to be considered for participation, patients will be screened using phq-4 questionnaire. scores \>3 will indicate positive pre-screen (i.e. can be considered for participation and formal screening). scores \< 3 will indicate negative screen (i.e. patient not considered for formal screening due to low risk for anxiety or depression). screening: * adults age ≥60 years * scheduled major thoracic, breast, or abdominal surgery for suspected or confirmed malignancy * phq-ads (patient health questionnaire anxiety and depression scale) ≥10 indicating clinically significant depression or anxiety symptoms. exclusion criteria: * barrier to communication (unable to read, speak, and understand english) * severe cognitive impairment screened by the sbt (short blessed test) \>10 * acutely suicidal * considered ineligible per the discretion of the oncologic surgeon or study pi * previous participation in this study or another cpmh study of the intervention bundle or its feasibility.

Keywords: behavioral activation medication optimization thoracic surgery oncologic surgery perioperative mental health
study of specific allergen immunotherapy in grass pollen allergic subjects by epicutaneous allergen administration

Conditions: Allergies

Summary: evaluation of patch as specific immunotherapy in allergic patients


Eligibility criteria:
inclusion criteria: * written informed consent * history of grass pollen allergic rhinitis * male and female between 18 years to 65 years * positive skin-prick test to grass pollen * positive conjunctival provocation test exclusion criteria: * eczematous skin lesions on the upper arms * perennial allergic rhinitis * symptoms of infectious disease with rhinitis in between the last 2 weeks * surgical intervention in between the last 30 days * pregnancy or nursing * history of hiv or aids * history of mastocytosis (cutaneous or systemic) * history of significant cardiovascular disease * hypertension (blood pressure \> 160 / 95) * history of significant pulmonary, renal and/or hepatic disease * history of significant hematological disorder * moderate or severe asthma * history of malignancy * history of neurological or psychiatric disease * history of autoimmune disease * antihistamines with longed half-lives in the last week * systemic or topical steroids for 5 days * active infectious disease * contraindicated medications: * immunosuppressive agents * betablockers * ace-inhibitors, at 2 antagonists * tricyclic antidepressants * daily use of beta-agonists or steroid inhalers * participation in another clinical trial /study at the moment or within the last 60 days

Keywords: rhinoconjunctivitis allergic
a global prospective observational registry of patients with pompe disease

Conditions: Pompe Disease

Summary: this is a global, multicenter, prospective, observational registry of patients with pompe disease, including those with late-onset pompe disease (lopd) and infantile-onset pompe disease (iopd). both untreated patients and those being treated with an approved therapy for pompe disease are eligible to participate. the objectives of the registry are: * to evaluate the long-term safety of pompe disease treatments through collection of data that describe the frequency of adverse events (aes)/serious adverse events (saes) occurring in pompe disease patients * to evaluate the long-term real-world effectiveness of pompe disease treatments * to evaluate the long-term real-world impact of pompe disease treatments on quality of life (qol) and patient-reported outcomes (pros) * to describe the natural history of untreated pompe disease


Eligibility criteria:
inclusion criteria: * diagnosis of lopd or iopd based on documented deficiency of gaa enzyme activity and/or gaa genotyping exclusion criteria: * patients who are currently receiving investigational therapy for pompe disease in a clinical trial, a compassionate use program, or an expanded access program (eap)
comparing smoking treatment programs for lighter smokers - 1

Conditions: Tobacco Use Disorder

Summary: the purpose of this study was to compare two different types of food and drug administration (fda) approved smoking cessation medications (nicotine patch or bupropion) used in conjunction with two levels of counseling. it was hypothesized that the higher level of counseling would have the highest rates of treatment completion and highest rates of abstinence.

the study compared a minimal level counseling model to a higher level counseling model plus one of two types of fda approved smoking cessation products (bupropion or the nicotine patch)used to achieve long term abstinence among lighter smokers. each participant received both products under blinded conditions meaning that neither the participant nor the counselor knew which product was real or a placebo. the primary goal was to determine the combination or combinations of high or low intensity counseling and pharmacotherapy (either bupropion or the nicotine patch) that were most effective for lighter smokers. the main hypothesis was that higher level counseling would contribute to improved outcomes meaning that more counseling would be associated higher abstinence rates following the completion of treatment and at longer term follow-up.

Eligibility criteria:
light smokers (6-15 cigarettes per day inclusion criteria: mentally and physically stable, non-pregnant, light smokers (6-15 cigarettes per day) exclusion criteria: please contact site for more information

Keywords: light smokers, smoking cessation treatment programs
phase ii iressa versus vinorelbine (invite)

Conditions: Non-Small-Cell Lung Carcinoma

Summary: this is a randomized, open label, parallel group, multi-centre, phase ii study of progression free survival, comparing oral zd1839 (iressa™) (250 mg tablet once daily) to vinorelbine 30 mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with locally advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed nsclc and willing to provide paraffin embedded tumour tissue * nsclc - locally advanced (stage iiib) or metastatic (stage iv) disease, not amenable to curative surgery or radiotherapy chemonaïve, life expectancy of 12 weeks * who performance status \<= 2 exclusion criteria: * newly diagnosed cns metastases * less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity. * hypersensitivity to zd1839 or intravenous vinorelbine * prior treatment with egfr inhibitors * other co-existing malignancies * alt/ast \>2.5 x ulrr * anc \< 2.0 x 10\^9/l or platelets \< 100 x 10\^9/l

Keywords: locally advanced or metastatic nsclc. stage iiib or stage iv lung cancer
covfis-home: covid-19 pilot study of fisetin to alleviate dysfunction and decrease complications

Conditions: Covid19; Coronavirus Infection

Summary: the purpose of this study is to test whether fisetin, a senolytic drug can assist in the reduction of complications in patients with covid-19 infection.

to determine whether short-term treatment with fisetin reduces the rate of death and long term complications related to covid-19 and to determine the safety of treatment with fisetin in this patient population.

Eligibility criteria:
inclusion criteria: * males and females, at least 18 years of age, capable and willing to provide informed consent; * patient must have received a diagnosis of covid-19 infection within the last 3 days; * outpatient setting (not currently hospitalized); * patient must possess at least one of the following high-risk criteria: 60 years or more of age, obesity (bmi ≥ 30 kg/m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥150 mm hg), known respiratory disease (including asthma, chronic obstructive pulmonary disease, or present or past smoking), known heart failure, known coronary disease, fever of ≥38.4°c within the last 48 hours, dyspnea at the time of presentation, the combination of high neutrophil count and low lymphocyte count; * female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (iud)) throughout the study and for 30 days after study completion; * patient or their caregiver must be able and willing to comply with the requirements of this study protocol. exclusion criteria: * patient currently hospitalized or under immediate consideration for hospitalization; * patient currently in shock or with hemodynamic instability; * patient with severe hepatic disease (as per clinical judgement) and liver enzymes \>10x the upper limit of normal; * female patient who is pregnant, breast-feeding, or is considering becoming pregnant during the study or for 1 day after the last dose of study medication; * patient currently taking sirolimus, tacrolimus, or other mtor inhibitors for other indications (mainly chronic indications represented by organ transplantation or autoimmune diseases); * on warfarin therapy; * patient with a history of an allergic reaction or significant sensitivity to fisetin; * patient undergoing chemotherapy for cancer; * patient is considered by the investigator, for any reason, to be an unsuitable study candidate.

Keywords: sars-cov-2
role of anti-bk virus neutralizing antibodies (bkv) as a prognostic marker for the development of nephropathy bk

Conditions: Graft Dysfunction

Summary: bkv nephropathy (bkv) is one of the most frequent complications of kidney transplantation. in the absence of specific anti-bkv treatment, pre-emptive reduction of immunosuppression is the main strategy that has proven effective in reducing the risk of bkvn. however, it exposes a transplant rejection risk estimated between 4 and 14% according to studies. despite the pre-emptive reduction of immunosuppression, a significant number of patients continue to progress towards bkvn suggesting that pre-emptive strategy is late. it's therefore urgent to develop new prognostic markers to identify earlier and more effectively patients with a higher risk of developing bkvn.


Eligibility criteria:
inclusion criteria: * patient over 18 years * grafted kidney patient between 1 july 2012 and 31 july 2014 at strasbourg university hospital with regular monitoring exclusion criteria: * patient under 18 years

Keywords: graft dysfunction graft loss kidney transplantation bkv anti-bkv nephropathy immunosuppression prognostic markers
fecal immunochemical test for advanced adenoma detection in colorectal cancer screening

Conditions: Colorectal Cancer; Colorectal Neoplasms; Colorectal Adenoma

Summary: early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. in order to reduce the incidence of colorectal cancer, improve the early diagnosis of colorectal cancer, the investigators conducted this study to explore diagnostic accuracy of fecal immunochemical test in colorectal cancer screening population.

colorectal cancer accounts for approximately 10% of all annually diagnosed cancers and cancer-related deaths worldwide. with progress of developing countries, it is predicted that the incidence of colorectal cancer worldwide will increase to 2.5 million new cases in 2035. the majority of colorectal cancer is thought to arise from precancerous lesions through the adenoma-carcinoma pathway. detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. in order to reduce the incidence of colorectal cancer, improve the early diagnosis of colorectal cancer, the investigators conducted this study to explore diagnostic accuracy of fecal immunochemical test in colorectal cancer screening population.

Eligibility criteria:
inclusion criteria: * adults 50-75 years old exclusion criteria: * people with history of intestinal surgery; * people with history of colorectal cancer; * people with history of inflammatory bowel disease, ischemic enteritis, vascular malformation of intestine or other disease resulting in intestinal tract bleeding; * people with symptoms including visible rectal bleeding, hematuria, severe and acute diarrhea; * pregnancy, lactation or menstrual phase; * severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.

Keywords: colorectal adenoma occult bleeding quantitative fecal immunochemical test
aripiprazole in patients with acute mania

Conditions: Bipolar Disorder

Summary: the purpose of this trial is to test the safety \& efficacy of aripiprazole in patients with bipolar mania for a period of at least 12 weeks.


Eligibility criteria:
inclusion criteria: * primary diagnosis of acute bipolar i mania exclusion criteria: * patients with a dsm-iv diagnosis other than bipolar i mania

Keywords: bipolar mania
the strontium chloride associated with photobiomodulation in the control of post-bleaching sensitivity

Conditions: Dentin Sensitivity

Summary: this study investigated the effects of the association of strontium chloride with photobiomodulation on the dental bleaching process, testing the hypothesis that they may control dental sensitivity post-bleaching teeth.

the objective of this double-blind, randomized, controlled clinical study was to evaluate the effect of 10% strontium chloride associated with photobiomodulation (fbm) on teeth exposed to 35% hydrogen peroxide during 3 weeks of whitening treatment. methods: 50 volunteers were evaluated by the split mouth model, where the hemiarchy patients were randomized and subsequently allocated to one of the experimental groups: placebo (negative control) - group with no desensitizing treatment, only bleached; fbm (positive control) - group treated with placebo gel and application of the lllt (low level laser therapy); estrôncio (positive control) - group treated with 10% strontium chloride and simulation of lllt application (without light emission); and fbm + estrôncio - group treated with lllt + 10% strontium chloride.

Eligibility criteria:
inclusion criteria: * good oral hygiene * absence of active caries lesions * never having undergone previous whitening therapy * not present dental hypersensitivity * don't be a smoker * not be pregnant * present at least 28 teeth in the oral cavity. exclusion criteria: * volunteers who were under orthodontic treatment, * presence of periodontal disease * dental cracks or fractures * restorations and prostheses on anterior teeth * extensive molar restorations * gastroesophageal disorders * severe internal dental darkening * presence of dentinal exposure in anterior and / or posterior teeth.