Kornimate/medical-research-clean huggingface dataset:
excretion of radiolabelled azd0837

Conditions: Healthy

Summary: this is an explorative study and the scientific question to be investigated in this study is if azd0837 and/or its metabolites ar-h069927xx and ar-h067637xx and other unknown metabolites are excreted into the bile.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 19 to 30 kg/m2 and body weight between 50 to 100 kg inclusive exclusion criteria: * significant illness, trauma or surgical procedures. * clinically significant laboratory abnormalities. * clinically significant medical history.

Keywords: pharmacokinetics
molecular signature of inactivity induced exercise responsiveness

Conditions: Metabolic Diseases; Aerobic Exercise

Summary: fitness is one of the best predictors for heart and brain disease. to increase ones fitness, the american heart association (aha) says to exercise at least 150 minutes per week or 75 minutes per week if really hard. these exercise guides are pretty effective, however not everyone will get the same results. what individuals do outside of the exercise bout can influence the effectiveness of exercise. one of these factors is our time sitting, which has caused the phrase "sitting is the new smoking". other studies have said that the metabolic benefits of exercise are decreased when you exercise after a few days of low activity (less than 5,000 steps per day). this is important in that exercise may not be able to fully offset these times of inactivity. however, these studies were only looking at different fats in the blood. as exercise increases fat burn up to 10 times in the muscle, more research is needed to understand how inactivity affects the muscle during exercise and after exercise. this study will help answer two questions: 1) how does a day of sitting a lot affect the muscle's ability to respond to exercise? and 2) how does a day of sitting a lot affect carbohydrate and fat burn during and after a bout of exercise? the investigators will answer these questions by having people complete one day of inactivity (less than 5,000 steps) or normal activity (more than 8,500 steps). subjects will then come in the next day to bike somewhat hard for 1 hour. the investigators will take blood samples before, during, and after exercise to measure energy sources. the investigators will also collect pieces of skeletal muscle before and after exercise to see how the muscle responded to exercise. this study is significant for the publication of exercise guidelines to minimize risk of heart and metabolic diseases.


Eligibility criteria:
inclusion criteria: * free from acute or chronic illness (cardiac, pulmonary, liver, or kidney abnormalities, cancer, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other known metabolic disorders) * free from orthopedic limitations (including any artificial joints) no known lidocaine allergy * do not currently smoke or participate in other forms of tobacco use. * not currently in a structured exercise program
the reduced trial: reducing the utilization of cesarean sections for dystocia

Conditions: Cesarean Section, Dystocia

Summary: this project is a clustered randomized controlled trial of a knowledge translation intervention of new acog guidelines for the diagnosis of poor progress in labor. the intent is to reduce the rate of cesarean section (cs) in first time mothers at term (\>= 37 weeks), with a vertex presenting singleton fetus, without increasing maternal or neonatal morbidity. the guidelines were developed from data from the consortium for safe labor. the unit of randomization will be sites in alberta that deliver

cluster randomized controlled trial of a knowledge translation intervention of new guidelines for the diagnosis of poor progress in labor. the intervention will be randomized to centres (the clusters) in alberta that provide intrapartum care, have facilities to perform cesarean section and deliver at least 70 primparous women annually, with stratification based on facility type and geographic location. clustering by centre and not individual caregivers (nurses/physicians) is necessary to prevent leakage or crossover of the intervention to controls. as all participating centres will eventually receive the intervention, the biostatistician will generate a randomization into two "waves". the intervention will be introduced sequentially by strata (calgary, edmonton, regional centres, rural centres) to the first "wave" hospitals in multi-week run-in periods after which those strata will be revisited for roll-out to the second "wave" hospitals.

Eligibility criteria:
inclusion criteria: * centers in alberta that provide intrapartum care, have facilities to perform cesarean section and deliver at least 70 primparous women annually exclusion criteria:
bactiseal catheter safety registry study

Conditions: Hydrocephalus

Summary: research purpose: this study aims to continuously evaluate the safety of subjects implanted with a catheter (trade name: bactiseal) produced by integra lifesciences production corporation. device safety will be assessed based on all the adverse events that occurred within 2 years after implanted the catheter. research design: this study is designed to be single arm, multi-center, and retrospective. a total of 200 subjects will be retrospectively enrolled. information will be collected on adverse events, including bacterial culture and drug resistance testing when infection (if done), of subjects enrolled within 2 years after the implantation of the bactiseal catheter between january 01, 2019 and june 30, 2022. the following information will be collected from subjects' medical records or hospitals' databases (if any): 1. general condition of the subjects (including previous shunting and external drainage operation) 2. intraoperative condition and catheter implantation 3. information on the shunt catheters 4. adverse events of subjects within 2 years after the operation and classification of the adverse events (except anticipated adverse events listed in section 8.1.2) 5. relevant examinations in case of postoperative infection, including bacterial culture and drug resistance testing (if done)


Eligibility criteria:
inclusion criteria: 1. the informed consent is exempted by the ethics committee of a research center. or a subject or his/her legal representative signed the informed consent form (icf) prior to the enrollment. 2. a subject had an indication suitable to use bactiseal catheter. 3. a subject implanted hydrocephalus shunt catheter for at least 2 years at the time of enrollment. exclusion criteria: 1. a subject didn't have an indication suitable to use the catheter. 2. a subject was known to be allergic to a component or ingredient of the catheter to be implanted, including silicone catheter, rifampicin, and clindamycin. 3. according to the comprehensive judgment of an investigator, a subject had an infection of the implant site when the shunt is implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection. 4. a subject was simultaneously implanted with another shunt catheter different from bactiseal catheter. 5. a subject had a contraindication of the shunt operation. 6. a subject had uncorrected coagulopathy or any bleeding disorder.

Keywords: hydrocephalus cerebrospinal fluid shunt antibiotic-impregnated catheter infection
genome-wide association study in patients with nontuberculous mycobacterial lung disease

Conditions: Mycobacterium Infections, Nontuberculous

Summary: the aim of this study was to elucidate genetic susceptibility of patients with nontuberculous mycobacterial lung disease using genome-wide association study.

nontuberculous mycobacteria (ntm) are ubiquitous environmental organisms. ntm lung disease is increasing, however, genetic susceptibility of patients with the disease have not been identified. to elucidate the genetic susceptibility of ntm lung disease, the investigators perform a genome-wide association study (gwas) including patients with ntm lung disease and healthy controls (case : control = 1 : 3). the age-, sex-matched control group will be recruited from the korean healthy twin study.

Eligibility criteria:
inclusion criteria: * case: patients with ntm lung disease satisfying diagnostic criteria suggested by american thoracic society * control: healthy subjects enrolled in the korean healthy twin study exclusion criteria: * case: none * control: 1) subjects who have respiratory symptoms including cough and sputum 2) subjects who have abnormalities on chest radiography
cognitive behaviour therapy (cbt) for body dysmorphic disorder (bdd)

Conditions: Body Dysmorphic Disorder

Summary: the aim of the research is to determine if cognitive behaviour therapy (cbt) specific for bdd is more effective than a credible non-specific form of cbt for treating bdd and its delusional variant in adults aged 17 or over. this will be done in a single centre randomised controlled trial that compares specific cbt for bdd versus non-specific cbt over 12 weeks. the hypotheses to be tested are that: (1) specific cbt for bdd will be more effective than non-specific cbt at 12 weeks (2) treatment effects from specific cbt will be maintained at 1 month follow up. the main study end-point is at 12 weeks and the secondary end-point is at 1 month follow up. a secondary aim is to explore whether delusionality (insight) as measured by the brown assessment of beliefs and co-morbid depressed mood predicts response to treatment.


Eligibility criteria:
inclusion criteria: * bdd is the main psychological problem. we will use dsmiv criteria as bdd does not exist as a separate diagnosis in icd10. they may have an additional diagnosis of delusional disorder when it refers to beliefs about being ugly or defective. * they must have a total of 24 or more on the twelve-item ybocs modified for bdd (phillips et al., 1997). * they may be of either gender but must be 17 years or above. * they are willing to travel to the treatment centre for weekly sessions. * they are wiling to complete regular questionnaires and be audiotaped for supervision and for listening to enhance their learning. * they may be taking psychotropic medication so long as it is stabilised and there are no plans to increase the dose. exclusion criteria: * they have a current or past diagnosis of schizophrenia, bipolar affective disorder. * they have current suicidal intent or severe self-neglect that requires hospitalisation. * they have a current alcohol or substance dependence or anorexia nervosa or borderline personality disorder that requires treatment in its own right. * they are currently receiving any other form of psychotherapy, * they have received cbt for bdd in the past 6 months, which is judged as competently delivered and did not respond. * they cannot speak sufficient english for cbt. (assistance will be provided for those who speak english but are unable to read questionnaires).

Keywords: cbt bdd
trial of provider-to-patient interactive voice response (ivr) calls to improve weight management in community health centers (chcs)

Conditions: Obesity

Summary: this study will test the effect of provider to patient interactive voice response (ivr) calls in local community health centers within a weight management program.

we will randomize providers to three groups. patients whose provider has been randomized to usual care will not receive ivr calls but do have available a guideline-level weight management service in tcl. groups one and two will receive pre-visit and post-referral calls. the pre-visit call will invite patients who want to discuss weight at their upcoming visit with their provider to remember to do so. the post-referral call will remind patients that they have received a referral and encourage them to schedule a visit with the community based weight intervention program. patients whose provider has been randomized to group 1 will receive ivr calls using their scheduled and referring provider's voice. group 2 will receive ivr calls using a standard ivr voice.

Eligibility criteria:
inclusion criteria: * adult patients who have screened positive for overweight or obesity exclusion criteria: * patients who have not screened positive for overweight or obesity

Keywords: urban community centers obesity obesity counseling low-cost intervention
efficacy of bacmune (mv130) in the prevention of disease due to covid-19 infection in healthcare personnel

Conditions: Covid19

Summary: the purpose of this trial is to assess the effect of immunotherapy with the bacterial preparation mv130 on the spread and course of sars-cov-2 infection in highly exposed subjets, as is the case with healthcare personnel.

this is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of bacmune (mv130) in the prevention of disease due to sars-voc-2 infection in healthcare personnel

Eligibility criteria:
inclusion criteria: * health personnel who are or have been in contact with patients with disease due to sars-cov-2 infection within the last 14 days before randomization. * negative result for test against covid-19. * subjects who have given informed consent. * men or women aged between 18 and 65 years, both included. * subjects who have a smartphone where they can load an app for monitoring the symptoms. exclusion criteria: * subjects who are participating in another clinical trial. * subjects who are unable to offer cooperation and/or have serious psychiatric disorders. * subjects who are allergic to any of the compounds included into mv130. * subjects who present contraindications to any of the components of bacmune (mv130). * subjects who are not able to comply with the dosage regimen. * subjects with immunodeficiencies. * subjects with malignancy involving the bone marrow or lymphoid systems. * pregnant or suspected pregnant women and breastfeeding women. * subjects in medical treatment that affects the response of the immune system. it includes corticosteroids (equal to or more than 20 mg for more than 2 weeks), immunosuppressants, biological agents (such as anti tnf-alpha monoclonal antibodies, etc.). * subjects with hiv. * subjects under treatment with metformin. * subjects treated with sertraline. * subjects treated with statins.
clinical impact of peroral endoscopic myotomy for esophageal achalasia

Conditions: Esophageal Achalasia

Summary: achalasia is a rare esophageal motility disorder, which is characterized clinically by symptoms of dysphagia, regurgitation, weight loss and chest pain. these symptoms are primarily caused by incomplete relaxation of a frequently hypertensive lower esophageal sphincter (les) and to some extent by a lack of peristalsis in the tubular esophagus. unfortunately, no therapy returns normal esophageal function. treatment is therefore directed at lowering the les pressure, with the aim of reducing the functional obstruction to bolus transit at this site. current treatments can be endoscopic or surgical. peroral endoscopic myotomy (poem) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia in some centers. the investigators purpose was to further evaluate the efficacy and the feasibility of poem for patients with achalasia in a prospective larger study.

1. patients were eligible for enrollment in the study if they had an eckardt symptom score ≥ 4. the diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the les on established methods (barium swallow, manometry, esophagogastroduodenoscopy (egd)). exclusion criteria were severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk, pseudoachalasia, and megaesophagus (diameter of \> 7 cm). 2. all patients were scheduled for a follow-up visit at 1 month after poem for egd and manometry. symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires. 3. the primary outcome of the study was therapeutic success (a reduction in the eckardt score to ≤3) at the follow-up assessment. the secondary outcomes included procedure-related adverse events, les pressure on manometry pre- and post poem, reflux symptoms and medication use before and after poem, and procedure-related parameters such as procedure time, hospital stay, and myotomy length.

Eligibility criteria:
inclusion criteria: * with an eckardt symptom score ≥ 4 * the diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the les on established methods (barium swallow, manometry, esophagogastroduodenoscopy) * informed patient consent was obtained exclusion criteria: * severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk * pseudoachalasia * megaesophagus (diameter of \> 7 cm)

Keywords: peroral endoscopic myotomy esophageal achalasia
experimental trial of rhifnα nasal drops to prevent 2019-ncov in medical staff

Conditions: 2019 Novel Coronavirus Infection

Summary: the investigators plan to carry out an experimental study on the preventive effect of recombinant human interferon alpha nasal drops on the infection of 2019 new coronavirus in medical staff.

the investigators plan to carry out an experimental study enrolling more than 2000 medical staff and divide participants into low-risk group and high-risk group according to whether they can directly exposed to 2019-ncov infected patients. in the low-risk group, participants will be given recombinant human interferon alpha-1b nasal drops (2-3 drops/nostril/ time, 4 times/ day), and in the high-risk group will be given preventive intervention with interferon nasal drops and thymosin-α (thymosin was injected subcutaneously once / week), and the intervention time is 28 days.

Eligibility criteria:
inclusion criteria: * formally serving medical staff in taihe hospital; exclusion criteria: * pregnant women; * severe chronic diseases who are unable to participate in daily routine work; * fever (temperature≥37.3 ° ) and / or respiratory symptoms.

Keywords: rhinf-α 2019-ncov prophylaxis
neuromodulation augmented cognitive training to improve cognitive flexibility in anorexia nervosa

Conditions: Active tDCS; Sham tDCS

Summary: the purpose of the study is to evaluate the use of a new brain stimulation tool called transcranial direct current stimulation (tdcs). tdcs is a new technique used to stimulate the brain. the investigators believe that it may help to change brain function in individuals with anorexia nervosa. the brain stimulation occurs outside the head. the tdcs procedure involves applying a small amount of electrical current across the scalp, for a short period of time. this small electrical current is able to change the electrical activity inside areas of the brain. in the current study, the investigators will ask participants to complete computer-based brain training sessions. while participants do the brain training exercises, they will receive either real tdcs for "sham" tdcs. "sham" tdcs means that participants might feel sensations like tingling or vibrations from the tdcs machine, but will not actually receive the electrical current. investigators will also ask participants to complete several tests to assess changes in brain function. the information gained from this study will help investigators to understand how tdcs could be used to improve brain function and learning in individuals with anorexia nervosa.


Eligibility criteria:
inclusion criteria: * age 18+ years * documented enrollment in residential-level treatment at the emily program and meeting criteria for an (bmi \<18.5). * participant must be capable of giving informed consent, based on university of california san diego (ucsd) brief assessment of capacity to consent (ubacc)39 risk assessment, which has been uploaded to ethos. * sufficient spoken english so as to be able to comprehend testing procedures. exclusion criteria: * substance abuse in the participant * neurological condition or other developmental disorder * serious psychiatric disorder known to affect brain functioning and cognitive performance * medical instability, which will be evident based on required admittance status in the residential treatment facility from which participants will be recruited. (the emily program residential treatment patients are followed closely by a medical provider, who routinely assesses medical stability throughout the duration of each patient's stay in the treatment facility; therefore, if a participant is not currently a patient in this setting and/or has been recently discharged from residential treatment setting due to medical need to receive higher level of care/inpatient-level care, they will be excluded from enrollment in this study). * mri contraindication \[based on center for magnetic resonance research (cmrr) prescreening protocol\] * tdcs contraindication (e.g., history of craniotomy, history of metallic cranial plates, screws, implanted devices).
xpress digital mammography system images for computer aided detection development

Conditions: Breast Cancer

Summary: the primary objective of this study is to acquire digital mammography images produced by the xpress digital mammography system in order to develop computer aided detection software and systems.

the proposed study is an image acquisition study of mammograms produced by the investigational digital system. women who meet the selection criteria and who agree to participate in the study will be imaged with the xpress digital mammography system at the clinical sites. these images will be provided to cad development companies to conduct their own development and testing. the cad development companies will be responsible for submitting their results to the fda for marketing approval of their cad systems. patients will be drawn primarily from those women scheduled for breast biopsy since this population has an enhanced probability of cancer. the intent is to enroll patients until at least 107 women with biopsy proven cancers, and at least 330 women who have negative mammograms are enrolled. all cancers found will be used in the study. it is anticipated that approximately 720 patients undergoing diagnostic mammography will need to be enrolled to yield 107 proven cancer cases. in addition, approximately 330 cases will be drawn from a screening population. the negative status of the screening cases will be established by selecting only cases classified as birads 1 or 2, and have a negative mammogram at one year follow-up. all images collected will be utilized to develop and test the cad systems, and may be used for further product development.

Eligibility criteria:
inclusion criteria cases selected for the study must meet all of the following criteria: * female * scheduled for a routine screening mammography or routine breast biopsy for non-palpable findings * any ethnic origin exclusion criteria patients meeting any of the following criteria will be excluded from the study: * any contraindication to mammography * pregnant or suspicion of being pregnant, or nursing * patients with palpable lesions * patients with internal breast markers in the region of interest * breast implants, without displaced views * significant recent breast trauma/acute mastitis * patient has previously undergone an excisional breast biopsy * patients with a history of breast cancer * unable or unwilling to give consent

Keywords: breast cancer screening mammograms breast biopsy