Kornimate/medical-research-clean huggingface dataset:
the effect of food intake on the pharmacokinetic of single dose sph3127 tablets in chinese health subjects

Conditions: Hypertension

Summary: this study is a single-center, randomized, open, double-cycle and double-cross and self-reflection phase ic clinical trial, to evaluate effect and safety of high fat diet on pharmacokinetics of sph3127 tablets. two panels, each consisting of ten participants (the number of single-sex subjects is not less than 1/3 of the total number) will be randomized to a or b groups.

participants who are in panel a will receive a single dose of a sph3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of sph3127 200mg after a high-fat breakfast. participants who are in panel b will receive a single dose of a sph3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of sph3127 200mg when limosis.

Eligibility criteria:
inclusion criteria: * the body mass index is 19 \~ 26kg/m2 (including the critical value), which allows the minimum weight of male to be 50kg (including the critical value) and 45kg (the critical value) for women. * before the study, participants have kown about the significance, potential benefits, inconveniences and potential risks of the study and can follow the research's procedure and already sign the informed consent exclusion criteria: * participant who pregnancy, lactating women, and plan to get pregnant within six months after the clinical trial * participant who has significant abnormal physical examination, laboratory examination results (such as: liver function examination - aspartate aminotransferase (ast) and alanine aminotransferase (alt) more than 1.5 times that of the upper limit of normal) * participant who has a history of cardiovascular, liver, kidney, digestive tract, nervous system, blood system, familial hematologic disease, abnormal thyroid function, or mental abnormality * participant who has drug allergy history, allergy constitution * participant who took oral contraceptives within 6 weeks * participant who used any drug (including chinese herbal medicine) within 1 week * participant who donated blood within 2 months * participant who participated clinical trials of any drug in the past 3 months (as subjects) * participant who has any positive result of virus serology check : human immunodeficiency virus antigen antibody (hiv ag/ab) and hepatitis c virus (hcv) - immunoglobulin g（igg)antibody to igg, hepatitis b surface antigen (hbsag) and treponema pallidum antibody (tp) * participant who are smoking, drinking, drinking coffee, strong tea and drug abusers * participant who the researchers believe that there are volunteers who are not suitable for the study
trial of buprenorphine/naloxone for opiate dependence - 2

Conditions: Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate dependence treatment.


Eligibility criteria:
please contact site for information.

Keywords: opiate dependence
comparative evaluation of three airway maneuvers in the unconscious apneic person

Conditions: Airway Morbidity

Summary: one-handed e-c clamp mask holding technique, two-handed mask ventilation with jaw thrust, and two-handed mask ventilation with triple airway maneuver are three common airway management maneuvers. sniffing position may improve ventilation between these three maneuvers. the investigators hypothesize that ventilation efficiency may be different between these three maneuvers whether the patient is in sniffing position or neutral position. the investigators would like to quantify this effect by measuring the expired tidal volume, airway pressure, etco2 slope and hemodynamic change between these three maneuvers during anesthesia induction.

mask ventilation is considered a important skill for airway management during general anesthesia induction and for apneic unconscious patients. one-handed e-c clamp mask holding technique, two-handed mask ventilation with jaw thrust, and two-handed mask ventilation with triple airway maneuver are three common airway management maneuvers. however, the efficiency of ventilation between these three maneuvers has to be clarified. besides, whether sniffing position or neutral position may improve ventilation between these three maneuvers is to be determined. the investigators will collect airway parameters of the patients receiving general anesthesia and measure the expired tidal volume, airway pressure, etco2 slope and hemodynamic change between these three maneuvers during anesthesia induction.

Eligibility criteria:
inclusion criteria: * adult patients(asa i-iii) scheduled for elective surgery requiring general anesthesia with endotracheal intubation. exclusion criteria: * pneumothorax * spo2\<96%(without additional oxygen supply) * vocal cord palsy * congenital airway abnormality * facial trauma or deformity * acute upper airway disease * inadequate fasting time * neck or potential cervical spine disease * temporal-mandible joint abnormality * head and neck tumor * status post radiotherapy * pregnancy * long term sedative or opioid drug use * patient refuse

Keywords: airway maneuver
comparison of response and recurrence rates following percutaneous microwave coagulation therapy versus percutaneous radiofrequency ablation

Conditions: Thermoablation; Chronic Liver Disease; Hepatocellular Carcinoma

Summary: to date, the majority of studies that have evaluated the efficacy of microwave ablation (mwa) in the treatment of hepatocellular carcinoma (hcc) lesions in cirrhotic patients and compared its efficacy with that of percutaneous radiofrequency ablation (rfa) for local recurrence and survival have been retrospective. there have been no prospective randomized studies comparing percutaneous microwave ablation (pmwa) with rfa for ablated tumour volume, the response after one session, local recurrence rates in the first year, complication rates and survival at 3 and 5 years for hcc lesions \> 2 cm in patients with child-pugh a and b cirrhosis. the hypothesis the investigators wish to explore is that though the 2 methods are equivalent for lesions ≤ 2 cm, mwa could show better efficacy with a similar risk for lesions \> 2 cm and for lesions close to vessels ≥ 3 mm in diameter, as shown in retrospective studies.


Eligibility criteria:
inclusion criteria: * patient who have been informed about the research and given their oral consent * patients with national health insurance cover * patients ≥ 18 years * ≤ 3 chc lesions ≤ 4 cm, with a maximum of 3 lesions with a diagnosis of hcc based on histology, or according to european society for the study of the liver (easl) criteria * chronic liver disease or cirrhosis with a child-pugh score between 5 and 8 points * contra-indication for surgical resection at the time of the therapeutic decision made during a multidisciplinary meeting exclusion criteria: * informed consent not obtained (refusal of patient or patient lacking discernment) * kidney failure with creatinine clearance \< 30 ml/min thus preventing the injection of contrast for the initial or follow-up radiological imaging * presence of a malignant tumour other than the hcc at the time of the diagnosis, unless a basocellular carcinoma * cirrhosis with a child-pugh score \> 8 * contra-indication for percutaneous treatment according to barcelona clinic liver cancer (bclc) criteria * patients without national health insurance cover
bdpp treatment for mild cognitive impairment (mci) and prediabetes or type 2 diabetes mellitus (t2dm)

Conditions: Mild Cognitive Impairment; Alzheimer's Disease

Summary: mild cognitive impairment (mci) represents a group of persons who are at risk of incident dementia in the near-term. persons with mci who have deficits in short-term recall (amnestic mci) are at significant risk of incident alzheimer's disease (ad) (termed prodromal ad), and thus represent a worthy target for secondary prevention interventions. there is increasing evidence that risk factors for metabolic syndrome (such as prediabetes and type 2 diabetes) increase risk of incident cognitive impairment and possibly ad, and evidence that the neurons of the ad brain are in fact insulin resistant with diminished glucose uptake under physiological conditions. thus, persons with mci and prediabetes or type 2 diabetes may be at particular risk of incident cognitive impairment and ad. a large clinical trial (accord)1 demonstrated that tight control of peripheral blood glucose does not improve cognitive (or other health) outcomes in older persons with peripheral insulin resistance. thus, there is a need to target cognitive outcomes in persons with mci and metabolic risk factors, and a drug targeting insulin resistance with good blood-brain-barrier (bbb) penetrance can potentially accomplish these objectives. while there is a phase iii study of intranasal insulin targeting this strategy, nutraceuticals offer a low-tech solution that would be more suitable to future secondary prevention trials in mci. bioactive dietary polyphenol preparation (bdpp) is a combination of two nutraceutical preparations grape seed polyphenolic extract (gse), and resveratrol that contain abundant concentrations of polyphenols. the investigators have found that oral bdpp administration was associated with improved cognition and brain plasticity long-term potentiation (ltp) in mouse models of metabolic syndrome and ad, as well as lowering brain amyloid and tau burden in an ad mouse model2-4. the investigators have demonstrated excellent absorption of oral bdpp in a small study in humans and similarly excellent csf penetration of oral bdpp in rats, but it is crucial to demonstrate safety and csf penetration of oral bdpp in humans to assess its potential as a treatment for mci and prediabetes or type 2 diabetes.


Eligibility criteria:
inclusion criteria: * age 50-90 years inclusive * amnestic mci * impaired fasting glucose (ifg), defined by american diabetes association criteria (fasting blood sugar between 100 and 125 mg/dl) or clinically stable type 2 diabetes * knowledgeable informant (ki) who spends at least 5 hours/week with the participant and can provide information about the participant's psychosocial functioning exclusion criteria: * deemed too unstable medically or neurologically to safely enroll in trial of research medication * type 1 diabetes mellitus * diagnosis of dementia due to alzheimer's disease
neuron specific enolase (nse) as outcome parameter of cooling therapy after survived sudden cardiac death

Conditions: Cardiac Arrest; Hypothermia

Summary: sudden cardiac death remains one of the major leading causes of death. therapeutic hypothermia is a validated standard procedure to avoid or minimize cognitive deficits after cardiac arrest. to assess the efficiency of different cooling methods and further improve these methods, the investigators collected blood samples to measure the neuron specific enolase (nse) in patients treated with invasive cooling as compared to patients treated with non-invasive cooling.

consecutive patients with restoration of spontaneous circulation after resuscitation due to sudden cardiac death were randomized to either non-invasive or invasive cooling for at least 24 hours. nse was collected at designated time points and compared between patients treated with invasive cooling and those treated with non-invasive cooling. neurological outcome was assessed between groups at hospital discharge and 6 months after discharge.

Eligibility criteria:
inclusion criteria: * rosc after sudden cardiac death (sca) due to vf/vt or pea/asystolia * gcs 3 exclusion criteria: * non-cardiac sudden death * pregnancy * unstable circulation with high-dose inotropics * life-expectancy reducing concomitant illness

Keywords: sudden cardiac arrest hypothermia coolgard arctic sun neurological outcome neuron specific enolase
a study of ly3076226 in participants with advanced or metastatic cancer

Conditions: Advanced Cancer; Metastatic Cancer

Summary: the main purpose of this study is to evaluate the safety of the study drug known as ly3076226 in participants with advanced or metastatic cancer.


Eligibility criteria:
inclusion criteria: * have advanced or metastatic cancer and be an appropriate candidate for experimental therapy. * part b: have a diagnosis of bladder cancer. * part b: have alterations of fgfr3. * have adequate organ function. * have discontinued previous treatments for cancer and have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior chemotherapy, surgery, or radiotherapy to grade ≤1 by national cancer institute (nci) common terminology criteria for adverse events (ctcae), version 4.0 (v 4.0). * if participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug. if the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 7 days of the first dose of study drug and must not be breastfeeding. exclusion criteria: * have received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device (other than the study drug/device used in this study) or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. * have preexisting corneal disease that may interfere with assessment for potential eye toxicity during the study. * have preexisting grade ≥2 skin disorder (for example, erythema, dermatitis). * have serious preexisting medical conditions (left to the discretion of the investigator). * have symptomatic central nervous system (cns) malignancy or metastasis (screening not required). participants with treated cns metastases are eligible for this study if they are not currently receiving corticosteroids and/or anticonvulsants, and their disease is asymptomatic and radiographically stable for at least 28 days. * have current acute or chronic leukemia. * have an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (hiv) or viral (a, b, or c) hepatitis (screening is not required). * have a second primary malignancy that, in the judgment of the investigator and sponsor, may affect the interpretation of results. curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is allowed. * have fridericia-corrected qt interval (qtcf) \>480 milliseconds on screening electrocardiogram (ecg). * have a serious cardiac condition, such as congestive heart failure; new york heart association class iii/iv heart disease; unstable angina pectoris; myocardial infarction within the last 3 months; valvulopathy that is severe, moderate, or deemed clinically significant; or arrhythmias that are symptomatic or require treatment (not including participants with rate-controlled atrial fibrillation).

Keywords: bladder cancer
effect of topical and systemic decolonization of staphylococcus aureus (sa) in pediatric cystic fibrosis (cf) patients

Conditions: Cystic Fibrosis

Summary: the primary objective of this study is to measure efficacy of our new protocol by monitoring the results of our routine respiratory cultures at the end of the new standard treatment, and during routine visits for 1 year from initiation of therapy for staphylococcus aureus. the secondary objective will include determining the clinical course (pulmonary exacerbations, antibiotic use, hospitalizations, pulmonary function tests) of patients who underwent the protocol.


Eligibility criteria:
inclusion criteria: eligible participants will include all patients with cf who test positive for sa from respiratory tract culture (throat, nares or expectorated sputum) and are 2-23 months of age at protocol presentation. exclusion criteria: patients co-infected with other bacteria (e.g. pseudomonas) or documented to have an allergy or resistance to any of the intervention substances will be excluded.
prognostic and predictive markers of response to treatment in patients with bile duct cancer: acabi pronobil study

Conditions: Biliary Tract Cancer

Summary: the objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy, targeted therapy,loco-regional treatments ) in patients with bile duct cancer. the effectiveness and tolerance of these treatments in current practice will also be evaluated.

bile duct cancers are a heterogeneous group of rare tumors with a poor prognosis. surgery is the only curative modality for localized forms. chemotherapy is the standard treatment in advanced forms. identification of prognostic and predictive markers to better stratify patients and to guide therapeutic decisions is a major issue. it is retro-prospective (diagnosis between 2003 and 2021) and prospective (diagnosis between 2021 and 2030) multi-center, cohort study. follow-up for 10 years from initial cancer diagnosis will be done. follow-up is retrospective only for patients operated on or diagnosed in the past for more than 10 years, and retro-prospective for operated patients or diagnosed in the past for less than 10 years. the data collected for each patient are available during the life cycle of this clinical trial to fulfil an educational requirement (e.g. a doctoral thesis) upon request and authorization from the study committee and the study sponsor (gercor).

Eligibility criteria:
inclusion criteria: * all locations of primitives (intrahepatic cca, extrahepatic cca, adenocarcinoma of the gallbladder; ampullomas excluded) * age \> 18 years * diagnosed between 2003 and 2030 (minimum follow-up 2 years) * written written non-opposition +/- signed informed consent for genetic studies (n.b.: exemption requested for a deceased patient) n.b. authorized inclusion in a therapeutic research protocol exclusion criteria: * patient under guardianship, curatorship or legal protection * pregnant or breastfeeding women * any medical, psychological or social situation, which could prevent the compliance with the protocol according to the investigator's assessment * refusal to participate in the study

Keywords: predictive prognostic biliary track cancer
comparison of cpap and gamow bag ventilation to treat hape

Conditions: High Altitude Pulmonary Edema

Summary: high altitude pulmonary edema (hape) is mostly treated with supplemental oxygen, nifedipine 30mg twice a day, rest, limiting cold exposure and descent (simulated or actual) gamow bag provides simulated descent and buy time for actual descent. cpap is claimed to be effective in many case reports to treat hape temporarily until actual descent is taken place. this study aims to evaluate the role of cpap in treating hape at those high altitude stations where gamow bag is not available and immediate descent is not possible.

background: swenson described hape in 2002, as a form of hydrostatic acute pulmonary edema with an alteration of alveolar-capillary permeability. overall prevalence of ams is 10-20% while incidence of hape, hace or mixed incidence is 2-3%. highest reported incidence of hape among indian soldiers climbing to siachen glacier is 15.5%. at 1500-2400m, a series of 52 patients admitted for hape over a period of 9 years was reported in literature.. scientific rationale: positive pressure has been used to increase altitude tolerance since the 1940s under simulated altitudes. peep applied via face mask increased spo2 and decreased ams symptoms. cpap was used after ascent to 3205 m on mount cook in new zealand where it improved spo2 and reduced symptoms of hape. a cpap helmet providing 15 cmh20 cpap improved spo2 in a single hape patient (at 5300 m) from 56% to 74%.-1st case report. a study at thorang la pass (5416 m) in october 2010 in the nepal himalaya found that nasal continuous positive airway pressure (cpap) is useful as an additional modality to treat presumed high altitude pulmonary edema (hape)- 2nd case report.

Eligibility criteria:
inclusion criteria: * male gender * age 18-45 years * previously fit and no comorbids * suspected hape --arrived in the past 01 week on the post * expected evacuation from post more than 8 hours exclusion criteria: * symptoms suggest acute infective etiology. * symptoms after one week of stay at ha * altered mental status. * disturbed balance * visual impairment * severe headache * a speedy evacuation to a lower height is available

Keywords: high altitude cpap hyperbaric chamber gamow bag ams
efficacy and safety of liposomal bupivacaine injection for paravertebral nerve block in the treatment of acute and chronic pain after thoracoscopic pneumonectomy: a multicenter, randomized, double-blind, controlled clinical trial

Conditions: Acute Pain; Chronic Pain; Postoperative Pain

Summary: the goal of this clinical trial is to evaluate the efficacy and safety of liposomal bupivacaine administered by paravertebral block for the treatment of acute and chronic pain after video-assisted thoracoscopic lobectomy.

researchers will compare liposomal bupivacaine to bupivacaine to see if liposomal bupivacaine works better to treat acute and chronic pain after video-assisted thoracoscopic lobectomy.participants will:1.received liposomal bupivacaine or bupivacaine paravertebral block before surgery. 2.keep a diary of their pain scores within 30min after recovery from anesthesia and 6h, 12h, 24h, 48h, 72h and 90d after the beginning of injection of experimental drugs.

Eligibility criteria:
inclusion criteria: * participants who scheduled for elective video-assisted thoracoscopic lobectomy under general anesthesia. * participants were 18 years or older. * 18 kg/m2≤bmi≤30 kg/m2 * participants with american society of anesthesiology (asa) physical status i-iii. * understand the significance, possible benefits, potential risks of the trial in detail.understand the procedures and methods of this study.willing to complete the trial in strict compliance with the clinical trial protocol.sign the informed consent form voluntarily. exclusion criteria: * with severe cardiovascular and cerebrovascular diseases such as myocardial infarction,unstable angina pectoris,severe cardiac rhythm disorders (second- and third-degree heart block,etc.), new york heart association (nyha) functional class iii/iv,ischemic stroke. * with psychiatric disorders (such as schizophrenia,depression,etc.) and cognitive impairment. * with sensory disorders such as hyperalgesia. * with other bodily pain. * allergy to amide-type local anesthetics or any of the trial drugs * taking drugs that affect liver metabolism,corticosteroids,benzodiazepines,non-steroidal anti-inflammatory drugs(nsaids),opioid agonist-antagonist,central-alpha 2-agonists,anticonvulsants,antidepressants within 72h. * with a history of alcohol or opioid abuse. * who were pregnant or lactating. * who were currently included in another clinical study within 3 months.