Kornimate/medical-research-clean huggingface dataset:
surufatinib as neoadjuvant treatment for locally advanced or metastatic differentiated thyroid cancer

Conditions: Differentiated Thyroid Cancer

Summary: locally advanced thyroid cancer has a wide range of surgery, large trauma and high local recurrence rate. it is one of the main causes of death in patients with thyroid cancer. therefore, more effective treatments are urgently needed. this study is designed to evaluate the efficacy and safety of the surufatinib for locally advanced thyroid cancer.


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic thyroid cancer confirmed by histology or cytology, including papillary thyroid carcinoma, follicular thyroid carcinoma, poorly differentiated thyroid cancer, particularly differentiated thyroid cancer. locally advanced stage refers to: 1) primary tumor with invasion or adhesion of organs and structures, such as recurrent laryngeal nerve, esophagus, trachea, larynx, encirclement of neck large vessels, mediastinal vessels, extensive invasion of skin, subcutaneous soft tissue or neck muscles; 2). ajcc t4 stage; 3). difficult to achieve r0/r1 resection during preoperative assessment; * age 14-75 years; * at least one measurable lesion (recist 1.1); * eastern cooperative oncology group (ecog) score 0-1; * expected survival time ≥ 12 weeks; * the main organ functions meet the following criteria: absolute neutrophil value (anc) ≥ 1.5 × 109 / l; platelet (plt) ≥80 × 109 / l; hemoglobin (hb) ≥9g / dl; white blood cell count\> 1.5 × 109 / l; total bilirubin (tbil) ≤ 1.5 times the upper limit of normal value (uln); alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 2.5 uln, if with liver metastases, alt and ast ≤ 5 uln; serum creatinine (cr) ≤ 1.5 uln or creatinine clearance (ccr) ≥ 50ml / min; * subjects of potential fertility are required to use at least one medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment and for 180 days after the end of the study treatment; the serum hcg test must be negative before the first medication. exclusion criteria: * prior treatment with anti-angiogenic small molecule targeted drugs; * received other anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, etc.) within 4 weeks prior to treatment, except for tsh suppression treatment; * allergy to the study drug ; * have a history of serious cardiovascular and cerebrovascular diseases; * patients whose imaging showed that the tumor had invaded the important blood vessels or the researchers judged that the tumor was likely to invade important blood vessels during the subsequent study period and caused fatal bleeding; * patients with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmhg or diastolic blood pressure ≥100 mmhg); * the patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); * the investigator considered that the subject was not suitable to participate in the study due to any clinical or laboratory abnormalities or other reasons.
a study to evaluate the effect of rifampicin or ltraconazole on pharmacokinetics of ensartinib in healthy volunteers

Conditions: Healthy

Summary: the purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose pk of ensartinib.


Eligibility criteria:
inclusion criteria: * male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (bmi) within the range of 19 \~ 26kg /m2; * clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the investigator; * the subjects should took effective contraceptive measures voluntarily from informed consent until 3 months after study completion； * able to comprehend and willing to sign an informed consent form. exclusion criteria: * those with a history of chronic systemic or serious diseases such as cardiovascular, liver, kidney, lung, gastrointestinal, nervous, musculoskeletal, hematopoietic or metabolic diseases, especially surgical conditions or conditions that may affect drug absorption, distribution, metabolism and excretion； * family history or presence of long qtc syndrome; history or presence of an abnormal ecg； * hepatitis b virus surface antigen (hbsag), hepatitis c virus antibody (hcv-ab), treponema pallidum antibody or human immunodeficiency virus antigen/antibody (hiv-ag/ab) is positive； * use of any medications (prescription drugs, over-the-counter drugs, chinese herbal medicines, health products, moderate or strong cyp3a inhibitors or inducers, etc) within 14 days prior to the first administration； * those who have special dietary requirements (habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages) and are unable to withdraw during the trial； * drug abusers, smokers or alcoholics； * those with a history of fear of needles and hemophobia, difficulty in blood collection or inability to tolerate venipuncture blood collection; * donation of blood ≥ 400 ml or receipt of blood products within 3 months before enrollment; * receive any vaccine within 1 months before enrollment； * participation in any other investigational drug study within 3 months before enrollment； * history of significant hypersensitivity to any drug compound or food； * other conditions that, in the opinion of the investigator, are not suitable for the subject to participate in this study.
shenfu injection improves arterial vascular reactivity

Conditions: Septic Shock; Shenfu; Vascular Reactivity

Summary: septic shock is a common and critical illness in icu.the vascular dysfunction of septic shock is manifested by vasospasm and decreased arterial vascular reactivity . current studies have shown that the main mechanisms of vasospasm and decreased arterial vascular reactivity include increased vasospasm and down-regulation of receptor sensitivity , and eventually cause a decrease in vascular smooth muscle contractility.a large number of vasodilators are released during septic shock, in which inducible nitric oxide synthase (inos) and prostacyclin (pgi2) are important vasodilators leading to septic shock vasospasm.at present, vasoactive drugs are widely used in clinically to improve vascular tone and are important means of circulation support. however, when the infection is heavier, the reactivity of the blood vessels to the vasoactive drugs is lowered, and it is difficult for the large doses of the vasoactive drugs to maintain the circulation stability. at this time, the use of vasoactive drugs alone does not benefit patients with septic shock and may require the combination of other drugs.from the perspective of chinese medicine, shock is a disease of yang. shenfu injection has the effect of rejuvenating the yang and replenishing the qi. this trial was designed to give patients with septic shock the use of shenfu injection to determine the specific effects of shenfu injection on vascular reactivity in patients with septic shock.


Eligibility criteria:
inclusion criteria: 1. diagnosed as septic shock according to 2016 ssc guidelines; 2. the dose of norepinephrine required to maintain map\>65mmhg ≥0.5μg/kg.min; 3. svri \<800 dyns/cm5.m2; 4. ci\>2.5l/min/m2; 5. the patient or the patient's family signed the informed consent form for this trial. exclusion criteria: 1. septic shock occurs more than 24 hours; 2. age \> 85 years old or \<18 years old; 3. pregnant or lactating women; 4. there are shock patients caused by other causes such as cardiogenicity and neurogenicity; 5. the terminal state of malignant tumor end-stage disease or the patient who is expected to die within 24 hours.
efficacy and safety study of yunnan baiyao on minor recurrent aphthous stomatitis

Conditions: Recurrent Aphthous Stomatitis

Summary: recurrent aphthous stomatitis (ras) is a common recurrent oral disorder with no curative treatment available to date. the challenge remains in patients that do develop drug resistance and/or secondary infection, although topical corticosteroids and antimicrobials are the first therapeutic choice. the aim of the study was to evaluate the efficacy and safety of an herbal extract of yunnan baiyao formulated in toothpaste as an alternative therapy for minor ras. yunnan baiyao is a well-known traditional chinese medicine, formulated in a powder or capsule form. it was initially and widely used in wounds for its anti-hemorrhagic hemostatic function, and further in gastrointestinal bleeding. yunnan baiyao powder has been generally applied on ras among chinese population. in this study, a randomized, double-blind, placebo-controlled clinical trial (from march 2010 to march 2011) was conducted on a cohort of 227 minor ras patients. the toothpaste containing yunnan baiyao was used twice daily as part of the patient's routine oral hygiene for 5 days. an assessment of ulcerative size and pain was recorded on day 0 (baseline), day 3 and day 5. any noted adverse reactions were recorded.


Eligibility criteria:
inclusion criteria: 1. both male and female aged 18 to 65 years old; 2. patients diagnosed as minor recurrent aphthous stomatitis with the duration of each ulcer in excess of 5 days; 3. fresh ulcers available with less than 72 hours eruption. exclusion criteria: 1. hypersensitive to various medical agents; 2. concurrent acute infectious disease; 3. pregnancy or lactation; 4. concurrent other immunology disorders; 5. accepting systemic administration of corticosteroids or immunosuppressive agents within 3 months; 6. aphthous-like ulcers related to certain systemic disorders such as ulcerative colitis, crohn's disease, behcet's syndrome, serious anemia; 7. aphthous-like ulcers related to drug such as non-steroidal anti-inflammatory drugs (nsaids) and anti-histamines; 8. accepting anaesthetic therapy within 24 hours, or systemic antibiotics within 2 weeks, or other management for oral ulcers within 72 hours prior to the study; 9. neoplasm patients; 10. volunteers of other clinical trials on medical agents or toothpaste within one month.

Keywords: yunnan baiyao recurrent aphthous stomatitis clinical trial
efficacy of cantharidin in molluscum contagiosum

Conditions: Molluscum Contagiosum, Skin Disease

Summary: the university of north carolina department of dermatology is conducting a clinical trial to evaluate a drug called cantharidin in the treatment of molluscum contagiosum. molluscum is a common dermatologic disorder caused by a poxvirus. molluscum typically presents with many flesh-colored bumps on the skin. it goes away on its own, though can last several months to several years. cantharidin is a topical medicine which is applied at the clinic visit. it is well tolerated by the majority of children.


Eligibility criteria:
inclusion criteria: * anyone aged 5-10 years with the clinical diagnosis of molluscum contagiosum. exclusion criteria: * anyone with immunosuppression including hiv or previous organ transplantation. * anyone taking immunosuppressive medications. * anyone who has previously received treatment with cantharidin. * any female who has had her first menstrual period.
investigation of chronic obstructive pulmonary disease (copd) phenotypes and endotypes in china

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this is a non-drug interventional cohort study, which aims to investigate the clinical, radiological and biological factors associated with disease progression in copd in china. participants will be recruited from multiple hospitals across guangdong province categorized as type a hospitals (those at prefecture-level and above) and type b hospitals (those below prefecture-level).


Eligibility criteria:
inclusion criteria: * male or female participants, aged 50-80 years inclusive. a female is eligible only if she is of non-child bearing potential. * body mass index (bmi) less than (\<)35. * a signed and dated written informed consent is obtained prior to participation. additional inclusion criteria for copd participants: * a baseline (post-bronchodilator) (fev1/fvc) ratio \<70 percent (%). * clinically stable and has no exacerbations for at least 1 month prior to recruitment. * ever smoker or never smoker. additional inclusion criteria for chronic bronchitis participants: * free from other significant diseases. * baseline post-bronchodilator fev1/fvc ratio more than (\>)70%. * chronic bronchitis is defined as at least 3 months of cough and phlegm in a year in the past 2 years. * clinically stable and has no exacerbations for at least 1 month prior to recruitment. * ever smoker or never smoker additional inclusion criteria for healthy participants: * free from any significant diseases * baseline post-bronchodilator fev1/fvc ratio \>70%. * a cat score \<10. * never smoker. passive smoker is not eligible. exclusion criteria: * having undergone lung surgery. * known respiratory disorders or significant inflammatory disease other than copd. * serious, uncontrolled disease (including serious psychological disorders) * confirmed cancer, unless participants in remission for more than or equal to (\>=)5 years. * participating or plan to participant in any clinical studies where investigational drugs were tested. * unable or unwilling to use required digital devices (sub- cohort only). * have evidence of alcohol or drug abuse. * have received a blood transfusion in the 4 weeks prior to study start. * on long-term oral corticosteroids. * unable to walk. * unable to read and understand mandarin chinese. additional exclusion criteria for copd participants: * current primary diagnosis of asthma (participants with a primary diagnosis of copd but who also had asthma \[asthma copd overlap {aco}\] could be included). * known disorders other than copd that may significantly impact clinical assessments additional exclusion criteria for chronic bronchitis participants and healthy participants: * known disorders that may significantly impact clinical assessments. * fvc \<80% predicted.

Keywords: copd phenotypes endotypes chronic bronchitis china healthy control
study to evaluate the safety, tolerability, pharmacokinetics and exploratory efficacy of nimacimab in patients with diabetic gastroparesis

Conditions: Diabetic Gastroparesis

Summary: this is a single blind phase 2a study to evaluate the safety, tolerability, pharmacokinetics, and exploratory efficacy of nimacimab in patients with diabetic gastroparesis.


Eligibility criteria:
inclusion criteria: * diagnosed with type 1 or type 2 diabetes * diagnosed with diabetic gastroparesis, defined by: 1. 3 month past or current history of symptoms of gastroparesis (e.g. nausea, vomiting, bloating, abdominal pain, or feeling full earlier than normal after eating) 2. screening or historical scintigraphy (3 years prior to screening) with \> 20% of solid contents retained at 4 hours. * bmi \>= 20.0 and \< = 50.0 kg/m2 exclusion criteria: * participants on prokinetic therapy should have these medications withdrawn at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through day 15 of treatment. * participants with any active prokinetic device are excluded, unless device is turned off for at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through day 15 of treatment. * participants who are currently participating in or have participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. * participants with uncontrolled diabetes. participants with controlled diabetes are allowed (insulin is allowed). hba1c\>9.9% at screening are excluded.
the efficacy and safety of montelukast sodium in the prevention of bronchopulmonary dysplasia

Conditions: Premature Birth; Infant, Very Low Birth Weight; Bronchopulmonary Dysplasia

Summary: this study is multicentered, prospective, randomized, opened, parallel, intervention study. the aim of this study is to evaluate the efficacy and safety of montelukast sodium in the prevention of bronchopulmonary dysplasia (bpd) in preterm infant, below 32weeks gestational age. the investigators evaluate the first effectiveness through the morbidity and mortality of bronchopulmonary dysplasia. and then, the investigators evaluate the second effectiveness through the oxygen index, the usage of mechanical ventilator about taking medicine after 2 weeks, oxygen utilization after 4 weeks, proinflammatory cytokine through the bronchial lavage fluid.


Eligibility criteria:
inclusion criteria: * preterm infants born at less than 32 weeks * birth 14 days after, oxygen or artificial ventilation who are using patient * more than 20cal/kg/d by enteral feeding * written consent of the parents exclusion criteria: * congenital anomaly * cardiovascular collapse * investigator's opinion

Keywords: montelukast bpd singulair prematurity
covid-19 related kidney damage

Conditions: Acute Kidney Injury

Summary: in this study, we investigate whether the early detection of risk factors in covid-19 associated acute kidney injury contributes to us in the early initiation of treatment. we predict that if acute kidney damage is detected early in patients with early risk factors, permanent kidney damage will be seen less. in addition, we think that covid-19 patients may have positive contributions to shortening treatment time and reducing treatment costs. in addition, we are investigating whether it has a positive effect on patients' survival. in other words, we are investigating the contribution of risk factors to early diagnosis and treatment, the effect on health expenditures and mortality in patients with covid-19 with acute kidney damage.


Eligibility criteria:
inclusion criteria: * over 18 aged * patients in icu exclusion criteria: * patients with known chronic renal failure * who have received dialysis treatment before * who are under 18 years of age
influence of intrauterine growth restriction on amplitude-integrated eeg in preterm infants

Conditions: Intrauterine Growth Restriction; Premature - Weight 1000g-2499g or Gestation of 28-37weeks; Neurodevelopmental Disorder; EEG; Spikes, Centrotemporal, Epilepsy of Childhood

Summary: objective: the impact of intrauterine growth restriction (iugr) on perinatal morbidity and long-term neurodevelopmental outcome has been published in numerous studies. throughout this analysis, the influence of iugr on the postnatal amplitude-integrated eeg (aeeg) in preterm infants below 30 weeks of gestation was assessed. the second concern was the correlation between the pattern of the aeeg in the first two weeks with neurodevelopmental outcome, comparing infants with and without iugr. methods: routinely assessed aeeg data of preterm infants with iugr born below 30 weeks of gestation in the years 2005 until 2007 were analysed retrospectively according to the aeeg score (combining occurrence of sleep-wake-cycles, background activity and suspected seizure activity). neurodevelopmental outcome was evaluated at 24 months using the bayley scales of infant development and standardized neurologic examination.


Eligibility criteria:
inclusion criteria: * preterm infants below 30 weeks of gestation exclusion criteria: * congenital anomalies * severe asphyxia

Keywords: iugr aeeg preterm infants neurodevelopmental outcome
post-mastectomy surveillance to detect recurrence in breast cancer patients

Conditions: Breast Cancer

Summary: currently, there is no standard recommendation for using imaging studies to check patients for breast cancer recurrence who have been treated with mastectomy. the investigator proposes performing in-office ultrasound examinations of these patients to determine if this would be helpful in identifying an expected 5-7% of patients with breast cancer recurrences following mastectomy.

the investigator hypothesizes that surgeon-directed ultrasound is a feasible, accurate, and cost-effective strategy for local recurrence surveillance in breast cancer patients after mastectomy. toward examining these hypotheses, the investigators propose the following specific aims: aim i: to determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound. aim ii: to determine the sensitivity and specificity of surgeon-performed ultrasound for the detection of post-mastectomy breast cancer recurrence. aim iii: to estimate the cost of performing surgeon-directed ultrasound for the detection of post-mastectomy breast cancer recurrence from the perspective of a third party payer relative to standard surveillance alone.

Eligibility criteria:
inclusion criteria: * must be ≥ 18 years of age. * histologic diagnosis of invasive (ductal or lobular) or in situ (ductal) breast cancer (american joint committee on cancer, 7th edition stage 0, i, ii, iii, or iv) -previously treated with mastectomy exclusion criteria: * pregnant or breast feeding. * cannot tolerate lying supine for breast ultrasound examination. * mastectomy for lobular carcinoma in situ, atypical ductal hyperplasia, or extensive microcalcifications in the absence of concurrent dcis or invasive breast cancer
study to evaluate antibody persistence in children previously vaccinated with infanrix hexa™ or infanrix-ipv/hib™

Conditions: Tetanus; Poliomyelitis; Haemophilus Influenzae Type b; Acellular Pertussis; Diphtheria; Hepatitis B; Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines

Summary: the aim of this study is to assess antibody persistence in infants who received three doses of infanrix hexa™ (dtpa-hbv-ipv/hib) or infanrix-ipv/hib™ (dtpa-ipv/hib) at 3, 5 and 11 months of age in study nct00307034.


Eligibility criteria:
inclusion criteria: * subjects who had received 3 doses of infanrix hexa™ or infanrix-ipv/hib™ in study nct00307034. * subjects who the investigator believes that parent(s)/legally acceptable representative(s) lar(s) can and will comply with the requirements of the protocol. * a male or female subject aged 5 years at the time of study entry. * written informed consent obtained from the parent(s)/lar(s) of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * child in care. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * use of any investigational or non-registered product within 30 days prior to blood sampling. * evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis b, and hib vaccination or disease since the study nct00307034, with the exception of hepatitis b vaccination in the dtpa-ipv/hib group. * administration of immunoglobulins and/or any blood products within the 3 months prior to blood sampling. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * family history of congenital or hereditary immunodeficiency.

Keywords: infanrix-ipv/hib long-term follow up persistence infanrix hexa