Kornimate/medical-research-clean huggingface dataset:
μ-opioid receptor polymorphism and opioid analgesia

Conditions: Pharmacogenetic and Duration of Labor Fentanyl Analgesia

Summary: in this prospective observational double-blind study, the investigators aim to assess the effect of the single nucleotide polymorphism of the μ-opioid receptor gene (oprm1, p.118a/g) on the duration of epidural fentanyl labor analgesia.

the single nucleotide polymorphism (snp), p.118a/g of the µ -opioid receptor gene (oprm1), may alter pain perception and individual response to opioid analgesia. this snp leads to a variant µ-opioid receptor in which an asparagine is substituted for aspartate as the 102nd amino acid of the receptor protein (p.asn102asp). at the investigators' institution, it is common practice to initiate labor analgesia with epidural fentanyl. no data are available to determine how the µ-opioid polymorphism affects pain perception and response to opioids, such as fentanyl, in the investigators' population. the investigators aim to assess the effect of the single nucleotide polymorphism of the µ-opioid receptor gene (oprm1, p.118a/g) on duration of epidural fentanyl labor analgesia. this is a prospective observational and double-blind study. before initiation of epidural labor analgesia, venous blood will be drawn into coded edta tubes. dna isolation and genotyping of oprm1:p.118a/g will be performed at the american university of beirut. in 250 parturients, labor epidural analgesia will be initiated with 100 µg of epidural fentanyl following a test dose of lidocaine and epinephrine. no drugs will be injected until second request of analgesia. patients will be divided into two groups based on their genetic groups: group a consists of wild-type homozygote (a118), and group g includes heterozygote and homozygote carrying the g118 allele. duration of fentanyl analgesia (primary outcome) will be compared. data will be presented as a mean ± sd or numbers and percentages. statistical analysis will be performed with the student's t-test, chi-square or fisher's exact test as appropriate. p value \<0.05 will be considered significant.

Eligibility criteria:
inclusion criteria: * nulliparous parturients ≥ 37 weeks gestation, with asa i or ii, with an uncomplicated course of singleton vertex pregnancy (in spontaneous labor or with spontaneous rupture of membrane), requesting epidural analgesia for pain relief exclusion criteria: * advanced cervical dilation (\> 5 cm) at the time of request for epidural analgesia * severe medical or obstetric complications (preeclampsia, uncontrolled pregestational diabetes, etc...) * multiple gestation * contraindication to epidural analgesia * local anesthetics or fentanyl allergy * history of chronic opioid use or recent acute opioid use.

Keywords: µ-opioid receptor polymorphism opioids opioid analgesia labor analgesia
exploring novel interventions to improve adherence in children with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the investigators know that adherence to medications in children with cystic fibrosis (cf) is poor. forgetfulness has often been reported as a barrier to adherence by both cf patients and their parents. many of the investigators patients also report being motivated by the results of their lung function studies (pfts) to stay adherent to their medications. in this study, the investigators would like to see if providing medication reminders and allowing patients to measure their lung function at home will lead to better adherence. this will be a pilot study to determine the feasibility of providing such as a device to children with cf.

this is a randomized controlled trial to assess the impact of home lung function monitoring and medication reminders on adherence, clinical outcomes and quality of life in children with cystic fibrosis (cf) who are between 10 and 21 years of age. participants will be randomly assigned to either an intervention group or a control group. those in the intervention group will receive a personal spirometer device that provides medication reminders and allows for lung function monitoring at home. the control group will receive the current standard of care. all participants will be aware that their adherence is being monitored over the course of the study using prescription refill data. changes in lung function, body mass index and rate of hospitalization will be used as measures of clinical outcome. responses to age-appropriate well-validated patient questionnaires will be used to assess the impact of the investigators interventions on quality of life and perceptions of treatment burden. since this device has never been previously studied in this patient population, the investigators would like to do a pilot study with 5 patients (3 in the intervention group and 2 in the control group) over a 3-month period to determine feasibility. this will also help us with the investigator power calculations and ultimately deciding the number of participants that will be needed for the larger study.

Eligibility criteria:
inclusion criteria: 1. age 10-21 years 2. confirmed diagnosis of cystic fibrosis (cf) either by a sweat chloride ≥ 60meq/l or the presence of two disease-causing mutations 3. patients must be clinically stable with at least 1 month from their last hospitalization or use of oral antibiotics for a pulmonary exacerbation 4. signed informed consent from the patient and/or from the parent/legal guardian, if younger than 18 years. exclusion criteria: 1. age less than 10 years or greater than 21 years 2. clinically unstable
the effect of mobilising patients using nature sounds on anxiety, pain and stress levels

Conditions: Anxiety; Pain; Stress; Laparoscopic Colecctomy; Mobilization; Nature Sound

Summary: the effect of mobilization using nature sounds on patients' anxiety, pain and stress levels


Eligibility criteria:
inclusion criteria: * individuals who are willing to participate in the study, * patients undergoing their first laparoscopic surgery due to gallbladder stones, * patients scheduled for elective surgical procedures, * patients with no hearing impairment, * patients with no vision impairment, * mentally stable individuals, * individuals who are open to communication and cooperation, * patients aged 18 years and older will be included in the study. exclusion criteria: * individuals with mental health issues, * individuals who are unwilling to participate, * patients with hearing impairment, * patients undergoing their second surgery (recurrent) due to gallbladder stones, * patients using hearing aids, * individuals who are uncooperative or unwilling to communicate, * patients who require emergency surgery will not be included in the study.
a study of bbt001 in healthy volunteers (hvs) and in adult patients with atopic dermatitis (ad)

Conditions: Atopic Dermatitis

Summary: this is a phase 1, randomized, blinded, placebo controlled, single ascending dose (sad) and multiple ascending dose (mad) study of bbt001 in healthy volunteers (hvs) and adult patients with moderate to severe atopic dermatitis (ad).

the study consists of three parts: * part a (single dose in hvs in sequential ascending dose cohorts, sad in hvs part) * part b (three repeated doses in hvs in sequential ascending dose cohorts, mad in hvs part) * part c (three repeated doses in patients with moderate to severe ad, mad in patients part)

Eligibility criteria:
key inclusion criteria (part a, b, c) 1. age of 18-65 years. 2. body mass index between 18-32 kg/m², capped at 120 kg. 3. negative pregnancy tests for women of childbearing potential. 4. willingness to refrain from alcohol consumption for 24 hours prior to each study visit. 5. non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers. 6. adequate contraception use (for men and women of childbearing potential). 7. no clinically significant abnormalities or history of relevant diseases. key inclusion criteria (part c only) 1. must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). inadequate response to topical treatments or where they are medically inadvisable. 2. moderate to severe atopic dermatitis 3. validated investigator's global assessment for atopic dermatitis (viga-adtm) score ≥3 4. atopic lesions cover ≥10% of body surface area (bsa) 5. average peak pruritus numeric rating scale (pp-nrs) score ≥4 in the 7 days before randomization. key exclusion criteria for (part a, b, c) 1. significant health issues, such as: diabetes, positive tests for human immunodeficiency virus (hiv), hepatitis c virus (hcv), or hepatitis b surface antigen (hbsag), immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections. 2. history of major metabolic, dermatological, liver, kidney, hematological, or other significant disorders. 3. clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function. 4. positive drug/alcohol tests or abnormal vital signs at screening or day -1. 5. abnormal electrocardiogram (ecg) findings 6. history of drug/alcohol abuse in the past 2 years. 7. donated \>500ml blood within 2 months of screening. 8. history of severe allergic reactions or hypersensitivity. key exclusion criteria for (part c only) 1. skin diseases other than atopic dermatitis, significant tattoos, or scarring. 2. receipt of immunoglobulin or blood products within 30 days. 3. atopic dermatitis with ocular symptoms or chronic ocular steroid use. 4. chronic pruritus from conditions other than atopic dermatitis. 5. acute/treated infections or chronic skin infections. 6. current use of sedating antihistamines or corticosteroids.
endocan in ventilator-associated pneumonia

Conditions: Serial Endocan Measurements

Summary: in this study; in patients undergoing mechanical ventilation, making the day series endocan measurements during the first 5 day to look at whether there is a relationship between the levels of vap with endocan. this relationship, if any, aimed to investigate whether correlated with clinical and laboratory findings \[presence of fever, pathological lung x-ray, the number of white blood cells (wbc), procalcitonin (pct), c-reactive protein (crp)\] .


Eligibility criteria:
inclusion criteria: * over 18 age * patients whether intubated and connected to a mechanical ventilator exclusion criteria: * patients intubated due to lung problems such as copd, asthma, pulmonary embolism , etc. * patients with brain tumors * patients with acute and chronic renal failure * patients with hypertension * patients with previously diagnosed infection * patients with extubated * patients using antibiotics or corticosteroids before bronchoalveolar lavage fluid samples taken
a study of paclitaxel with or without ramucirumab (ly3009806) in participants with gastric or gastroesophageal cancer

Conditions: Gastroesophageal Junction Adenocarcinoma; Gastric Adenocarcinoma

Summary: the purpose of this study is to evaluate the efficacy of the study drug known as ramucirumab in participants with gastric and gastroesophageal cancer.


Eligibility criteria:
inclusion criteria: * have an eastern cooperative oncology group performance status (ecogps) of 0 or 1 at study entry. * have a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (gej) adenocarcinoma. * have metastatic disease or locally advanced, unresectable disease. * have at least 1 measurable lesion based on response evaluation criteria in solid tumors (recist), version 1.1. * have experienced documented objective radiographic or symptomatic disease progression during first-line therapy, or within 4 months after the last dose of first-line therapy with any platinum/fluoropyrimidine doublet for unresectable or metastatic disease. * have adequate organ function. * have urinary protein ≤1+ on dipstick or routine urinalysis. exclusion criteria: * have undergone major surgery within 28 days prior to randomization. * have received any first-line chemotherapy other than platinum and fluoropyrimidine with or without anthracycline for advanced gastric or gej adenocarcinoma. * have received any previous systemic therapy (including investigational agents) targeting vascular endothelial growth factor (vegf) or the vegf receptor signaling pathways. * have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to randomization. * have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal (gi) tract within 3 months prior to study entry. * have a history of gi perforation and/or fistulae within 6 months prior to randomization. * have experienced any arterial thromboembolic event within 6 months prior to randomization. * have uncontrolled arterial hypertension (systolic blood pressure ≥160 millimeters of mercury \[mmhg\] or diastolic blood pressure ≥100 mmhg) despite standard medical management. * have a serious or nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to randomization. * have a serious illness or medical condition(s).

Keywords: second line angiogenesis vascular endothelial growth factor receptor 2
the effects assessment of the polygonatum kingianum extract on endurance performance and anti-fatigue

Conditions: Fatigue

Summary: to assess the efficacy of polygonatum kingianum extract on endurance performance and anti-fatigue


Eligibility criteria:
inclusion criteria: * healthy male aged 30-60 years old * must read and sign the informed consent form * during the experiment, do not change the lifestyle and eating habits * cooperate not to engage in high-intensity exercise 48 hours before each experiment exclusion criteria: * subject who is not willing to participate in this study. * people with serious diseases of heart, liver, kidney, endocrine and other organs (such as hypertension, diabetes, renal dysfunction and heart-related diseases) and mental patients * people who have undergone surgery within 6 months or have lower limb injuries * people who are allergic to polygonatum kingianum extract * participate in other clinical trials related to anti-fatigue within four weeks of the trial * students who are currently taking courses taught by the principal investigator of this trial.
an investigational immuno-therapy study of relatlimab plus nivolumab compared to various standard-of-care therapies in previously treated participants with recurrent, advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma

Conditions: Gastric Cancer; Cancer of the Stomach; Stomach Cancer; Gastroesophageal Junction

Summary: the purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (gc) or gastroesophageal junction (gej) adenocarcinoma that has come back or spread to other places in the body after prior therapy.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * histologically or cytologically confirmed locally advanced or recurrent or metastatic gc or gej adenocarcinoma that is considered incurable by local therapies such as radiation or surgery * evidence of progressive disease (pd) on at least one prior platinum- and fluoropyrimidine-containing chemotherapy regimen * available tumor tissue for biomarker analysis exclusion criteria: * must not have squamous cell or undifferentiated gc or gej * untreated known central nervous system (cns) metastases * uncontrolled or significant cardiovascular disease other protocol defined inclusion/exclusion criteria could apply
increasing lung transplant availability using normothermic ex vivo lung perfusion (evlp) at a dedicated evlp facility

Conditions: Lung Diseases

Summary: the objective of this study is to evaluate the safety and effectiveness of the centralized lung evaluation system (cles) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end stage, survival-limiting lung disease in need of lung transplantation. this will be accomplished by evaluating subject survival at the later of 12 months or hospital discharge post-transplant.


Eligibility criteria:
inclusion criteria: * male or female; * aged 18 years or older; * informed consent is given for participation in the study by the patient or patient's designated representative; and * patient undergoes lung transplantation. exclusion criteria: * patients listed for same-side lung re-transplantation. * patients listed for multiple organ transplantation including lung and any other organ. * patients listed for live donor lobar lung transplant. * patients positive for human immunodeficiency virus (hiv) or burkholderia cenocepacia infection. * patient receives a standard of care (non-evlp) lung transplant but does not match to an evlp subject based on the criteria for control matching. * participating in another interventional trial

Keywords: evlp ex vivo lung perfusion organ perfusion cles centralized lung evaluation system united therapeutics
oral direct factor xa inhibitor rivaroxaban in patients with acute symptomatic pulmonary embolism - the einstein pe study

Conditions: Pulmonary Embolism

Summary: this is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic pulmonary embolism (pe) with or without symptomatic deep-vein thrombosis (dvt) (einstein-pe).

within the us 'johnson \& johnson pharmaceutical research \& development, l.l.c.' is sponsor.

Eligibility criteria:
inclusion criteria: * confirmed acute symptomatic proximal pe with or without symptomatic dvt exclusion criteria: * legal lower age limitations (country specific) * thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of dvt and/or pe * other indication for vka than dvt and/or pe * the pre-randomization anti-coagulant treatment (criteria # 4) has been prolonged from 36 hours to a maximum of 48 hours.
spirituality teaching program for depressed adults

Conditions: Major Depression

Summary: major depression is a widely spread health problem in canada. recent research suggests a potential role for religion/spirituality in the prevention of and recovery from depression in adults. the purpose this study was to assess the efficacy of a home-based spirituality teaching program for adults in the treatment of major depression. the objectives of the study were to determine: 1. whether the spirituality teaching program is efficacious in improving depression severity, response rate, and remission rate in adults, 2. whether efficacy is maintained long term (over a 16 week period).

major depression is a widely spread health problem in canada with a life time prevalence of 11% in men and 16% in women. a recent avenue of research suggests a role for religion/spirituality in the prevention of and recovery from depression. it has been hypothesized that religion/spirituality acts as a coping resource in distressing life situations including illness and loss and may address the struggles of depressed patients of feeling separated from their surrounding world, as well as from their inner self. majority of the research conducted to date on this topic has been observational and focused on the religious denomination, primarily the christian and muslim faiths. however, given the distinction between spirituality and religion and since a growing portion of the canadian population identifies themselves as nonreligious but spiritual (10), it is pertinent to explore whether there is a role for a nondenominational spiritual intervention as a mental health resource. considering the burden of depression on an individual and social level and need for effective and accessible treatment options, evaluation of spirituality based approaches is highly relevant. this study aims to assess whether nurturing spiritual coping resources in a non-faith based way may play a therapeutic role in recovery from major depression in adults.

Eligibility criteria:
inclusion criteria: * satisfy the dsm-iv criteria for unipolar major depression with a depression score of 18-22 on the hamilton depression scale (mild to moderate severity), * are at least 18 years of age, * have the competence to understand the study requirements and the ability to comply with the study intervention, * have provided written informed consent. exclusion criteria: * history of treatment resistance to two or more antidepressants when treated for an adequate period with a therapeutic dose * history of bipolar d/o, psychotic d/o, any psychotic episodes, personality d/o (except obsessive compulsive d/o) * history of multiple suicide attempts * acute psychiatric condition other than unipolar depression * regular use of medications (other than antidepressant, if applicable) that have mood altering effects, such as narcotics, anticonvulsants, illicit drugs or sleeping pills * uncontrolled medical conditions in the last 3 months * dsm-iv diagnosis of substance abuse (except nicotine and caffeine) within the past 12-months * high suicide risk

Keywords: major depression spirituality randomized clinical trial
circadian changes of the hypothalamic activity in patients suffering from cluster headache

Conditions: Cluster Headache

Summary: cluster headache attacks do not occur randomly throughout the day, but have a clear circadian rhythmicity. the aim of this study is to investigate circadian changes of the brain, the autonomic nervous system and pain processing systems.

cluster headache attacks do not occur randomly throughout the day, but have a clear circadian rhythmicity. the aim of this study is to investigate circadian changes in the functional connectivity, spectroscopy, iron deposition and perfusion of the brain. in addition, we plan to investigate circadian changes in the pain threshold of the brain using quantitative sensory testing (qst). finally, we will investigate changes in the autonomic nervous system measuring the pupillary response.

Eligibility criteria:
inclusion criteria: * diagnosis of cluster headache (ch) may enter the patient group, patients not suffering from ch may enter the control group. * knowledge of the german language suffices to understand the information sheet and consent form * having read, understood and signed the consent form exclusion criteria: * pregnancy * contraindications for the mri scan (particularly metal splinters, ferromagnetic devices and implants) * claustrophobia * obesity (mri \> 35 kg/m2) * shift working (last night shift must date back more than one week) * jet lag (last travel over more than two time zones must date back more than one week)

Keywords: primary headache trigeminal autonomic cephalgia functional connectivity