Kornimate/medical-research-clean huggingface dataset:
single dose lipopolysaccharide (lps) study in healthy volunteers

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: a single dose study with the inhaled anti-inflammatory agent pf-03715455 to establish if it has anti-inflammatory activity following a challenge with lps. inhaled lps invokes an acute inflammatory response in the lung which can be seen in induced sputum. ph-0797804 is an internal control for the study.

proof of mechanism

Eligibility criteria:
inclusion criteria: * male or female (of non-child bearing potential) subjects, aged 18-50 years. * subjects whose fev1 and fvc at screening are both greater than or equal to 80% of their predicted value for age, race, sex and height. * subjects who have normoresponsive airways. * subjects who are able to successfully complete screening sputum inductions. exclusion criteria: * subjects who have evidence, on review of pre-study laboratory data and full physical examination, or history of any clinically significant hematological, renal, endocrine, gastrointestinal, dermatological, hepatic, psychiatric, neurologic diseases. specifically liver function tests and crp must be within the reference range. * subjects with a medical history of asthma symptomatology (ie, wheeze and/or dyspnea at rest). * subjects who have experienced a respiratory tract infection within the previous 4 weeks or any other infection within 1 week of dosing

Keywords: healthy
comprehensive magnetic resonance in peripheral arterial disease.3

Conditions: Peripheral Arterial Disease

Summary: the goal is to test the ability to detect improved calf muscle perfusion and energetics in pad patients in a randomized controlled trial of home exercise therapy. eighty patients will be randomized to a 12 week home exercise program or no program (control).

the goal is to test the ability to detect improved calf muscle perfusion and energetics in pad patients in a randomized controlled trial of home exercise therapy. eighty patients will be randomized to a 12 week home exercise program or no program (control). patients will be studied before and after program completion with mri/mrs, calf muscle biopsy for capillary density, and exercise performance measures. arterial spin labeling peak exercise calf muscle perfusion will be used as the primary endpoint in the most symptomatic leg. all will undergo asl, peak exercise pcr recovery kinetics, calf muscle biopsy, and functional measures including treadmill exercise, vo2 testing, and 6-minute walk. correlations will be examined between changes in perfusion and energetics with changes in capillary density, peak vo2, and functional capacity from before to after completion of home exercise therapy.

Eligibility criteria:
inclusion criteria: * documented abi 0.5-0.9 * ability to walk on treadmill exclusion criteria: * lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment * critical limb ischemia * known or suspected peripheral neuropathy, heel cord contracture and foot deformity * other conditions that limit walking, e.g. lung disease or arthritis * active coronary artery disease such as unstable angina, significant left main disease or three vessel coronary artery disease (\>70% stenosis, unprotected by grafts) or recent (\<2 months) myocardial infarction, * bmi \> 40, * known contraindication to mri (intracardiac pacer, defibrillator, certain intracranial aneurysm clips, intraocular or cochlear implants, claustrophobia, etc.) * allergy to lidocaine or xylocaine (local anesthetic)

Keywords: peripheral arterial disease exercise perfusion energetics magnetic resonance imaging magnetic resonance spectroscopy
follicle stimulating hormone (fsh) receptor polymorphisms in in-vitro fertilization cycles.

Conditions: Infertility

Summary: this study is being done to identify if certain sequences (patterns) of key genes (called polymorphisms) may predict a response to fertility medications. the investigators will also determine if the individual response to fertility medications affects pregnancy rates in in-vitro fertilization.

all ivf patients who meet inclusion criteria and not exclusion criteria will be asked to participate in this study. upon consent, a blood sample will be obtained in 2 edta containing lavender topped tubes before, during or within 3 months after their ivf cycle. genomic dna will be extracted and saved for genotyping. the investigators will collect data on each individual's age, ethnic background, and estradiol levels on the day of hcg administration, total gonadotropin amount, clinical pregnancy rates, basal fsh levels, and occurrence of ohss. the investigators will then analyze all samples from all patients for their fsh receptor genotypes. patients will be compensated $75 via a check within 6-8 weeks of their blood drawn.

Eligibility criteria:
inclusion criteria: 1. 100 women less than 35 years old at time of signing the informed consent form. 2. day 3 fsh level less than or equal to 10 miu/ml with an estradiol \< 70 pg/ml 3. day 3 antral follicle count of greater than 10 follicles total. 4. couples who have male factor infertility, tubal factor infertility, and unexplained infertility. exclusion criteria patients who have: 1. endometriosis 2. polycystic ovarian syndrome

Keywords: infertility fsh receptor polymorphisms
low stable pressure pneumoperitoneum in colorectal surgery (cross study)

Conditions: Colorectal Surgery; Benign or Malignant Rectal or Colon Tumors

Summary: the objective of this prospective, international cohort is to incorporate the low stable pressure (using airseal insufflator) approach and its associated parameters into the early rehabilitation program after colorectal surgery so as to shorten hospitalization up to the ambulatory care and reduce postoperative pain and opioid consumption.

laparoscopy is currently the gold standard for the vast majority of abdominal surgeries, and especially for colectomy for cancer or benign diseases. there are many data showing the benefits of the laparoscopic approach to colectomy in terms of morbidity, post-operative pain and analgesic consumption, length of hospital stay, cosmetic results, and improved patient satisfaction. in 2002, consensus european guidelines recommended insufflating at the lowest pressure that still provides sufficient exposure. considering these results, low-pressure laparoscopy is one of the alternatives that have been developed to do away with the complications of the pneumoperitoneum while retaining its advantages. however, other factors may influence the outcomes of the low-pressure pneumoperitoneum such as the use of humidification and warming gaz, robotic or microsurgical instrumentation, neuromuscular blockade, patient positioning, pre-stretching of the abdominal wall, ventilation-induced changes, and probably individual patient factors like obesity. these parameters could not be separately tested in randomized trial. we should consider all these parameters in a prospective international registry in order to optimize the benefit of low-pressure pneumoperitoneum in post-operative recovery.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * colonic resection (right or left) performed for benign or malignant pathology * partial or total mesorectal excision (pme or tme) with or without stoma for benign or malignant pathology * laparoscopic or robotic procedure * surgery under low stable pressure pneumoperitoneum with airseal * patient who benefits by medicare system * oral agreement after reading information letter exclusion criteria: * laparotomy procedure * associated resection (except appendectomy or liver biopsy) * transverse colectomy * emergency procedure * pelvic sepsis * pregnancy or breast feeding period * legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to agree to participate in the study * persons deprived of liberty or under guardianship

Keywords: colorectal pathology low stable pressure laparoscopic length hospital stay
virtual reality for pain management study

Conditions: Pain, Acute

Summary: virtual reality (vr) is one non-pharmacological method that has shown promise as an effective means of decreasing pain levels following treatment, and for significant periods of time. additionally, neurobiology studies of vr have demonstrated a decrease in brain activity associated with pain. while vr is clearly a promising, drug-free option for pain treatment, existing vr systems are expensive and use unconvincing graphics. recent advances in vr technology (i.e., improved realism and immersion using 360-degree 3d technology and more affordable delivery systems) allow the development of more realistic and more cost-effective applications. capitalizing on these advances and the investigators' experiences with vr intervention development and evaluation, the current study will test a state-of-the-art vr experience in pain management intervention (live-action 360° video virtual reality(vvr)) and compare it to established standard computer generated imagery (cgi) 360° vvr content for pain management intervention in a medical setting. the participant's participation will help the investigators determine which vr intervention is most effective in reducing acute pain in hospital patients.


Eligibility criteria:
inclusion criteria: * between the ages of 18 and 65 * reports experiencing current pain not typical of day-to-day experience during pre-treatment pain questionnaire at the onset of study visit by answering "yes" to the first question of the questionnaire. there is no specific threshold of how much pain the participant must be in to be eligible for this study. the participant must be experiencing current pain that is not related to day-to-day, normal experiences (such as minor headaches, sprains, and toothaches). * scores a 15 on the glasgow coma scale and a 7 or above on the abbreviated mini mental status exam. * patient in the acute and critical palliative care units, post surgical units, or acute care orthopedic units at university medical center brackenridge in austin, tx. * willing and able to provide informed consent and participate in the study visit and study follow-up questionnaire. exclusion criteria: * hearing or visually impaired where participant cannot use the samsung gear vr. * does not report experiencing current pain during pre-treatment pain questionnaire at the onset of study visit. * scores below a 15 on the glasgow coma scale and/or below a 7 on the abbreviated mini mental status exam * limited mental competency and the inability to give informed, voluntary, written consent to participate.

Keywords: pain virtual reality opioid prescription pain reliever treatment
effects of aerobic training on exercise capacity in patients with cirrhosis

Conditions: Cirrhosis

Summary: cirrhosis is associated with a reduction in muscle mass and exercise capacity. this has an impact or morbidity and mortality. regular aerobic exercise training is a proven effective therapy to improve exercise capacity in healthy and clinical populations. the effect of this training has not yet been evaluated in cirrhosis. the safety of this intervention also requires further study. using a randomized controlled design, the investigators aim to conduct a pilot study evaluating the safety and efficacy of eight weeks of aerobic exercise training on aerobic capacity.


Eligibility criteria:
inclusion criteria: * age ≥18 and ≤70 years * cirrhosis * child pugh class a or b * if required, primary or secondary variceal prophylaxis in place exclusion criteria: * post-liver transplantation * hepatocellular carcinoma * active non-hepatocellular carcinoma malignancy * significant cardiac disease - ejection fraction \<60% or known coronary artery disease * oxygen saturation at rest \<95% * known myopathy * hemoglobin (\<100 g/l) * chronic renal failure on dialysis * physical impairment making it impossible to ride an exercise bike or treadmill * orthopedic abnormality preventing exercise training * hiv infection * patient unwilling to consent to study
a study on the effects of two nicotine replacement products on tooth staining

Conditions: Tobacco Dependence

Summary: participants will be smokers who want to quit, and have visible nicotine stains on their teeth. they will be given toothpaste and a toothbrush to use during the study, and will have an equal chance of being assigned to use either a nicotine gum or microtab. they will visit the study site five times during the 12 week trial to have their teeth examined.

this evaluator-blinded, randomized, 12-week parallel-group controlled trial compares nicorette® freshmint gum versus nicorette® microtab in healthy smokers who are motivated to quit smoking and who have visible staining of teeth. the trial is comprised of five visits (baseline, weeks 1, 2, 6, and 12). at baseline, subjects will be provided with a standardized toothpaste and toothbrush; use of any other oral hygiene or tooth-whitening product is prohibited. at all visits after baseline, smoking status and use of study treatment will be checked. teeth staining and teeth shade will be rated at baseline and at 2, 6 and 12 weeks using the modified lobene stain index and the vita® shade guide, respectively.

Eligibility criteria:
inclusion criteria: * males and females aged 18 to 65 years * daily smoker, current daily smoking for at least 1 year * motivated to quit smoking, and willing to use nrt (nicotine gum or nicotine sublingual tablet) * normal chewing abilities (able to use chewing gum without any problems) * willing to refrain from dental prophylaxis for the duration of the 12-week trial * have a minimum of 20 natural teeth, with at least 10 of the 12 anterior teeth present and scorable. * have a total extrinsic facial tooth stain score equal or more than 28, according to the macpherson modification of the lobene stain index. * willing and able to comply with scheduled visits, treatment plan, tests, and other trial procedures. exclusion criteria: * use of other tobacco-containing products, such as cigars, pipe, smokeless tobacco products, etc. * existing use of any nicotine replacement products for smoking cessation, or undergoing any other treatment for tobacco dependence, such as hypnosis, acupuncture, bupropion, etc. * orthodontic appliances * gross periodontal disease, or signs of gross oral neglect * history of oral cancer * history of temporomandibular joint disorders known to aggravate jaw pain * unstable angina pectoris or myocardial infarction during the previous 3 months * pregnancy, lactation or intended pregnancy * any major metabolic disease, clinically important renal or hepatic disease suspected alcohol or drug abuse * participation in another clinical trial within the previous three months and during study participation * any other severe acute or chronic medical or psychiatric condition that might increase the risk associated with trial participation or trial drug administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, makes the subject inappropriate for entry into this trial.

Keywords: tooth staining
comparison evaluation of blood glucose meter systems

Conditions: Diabetes

Summary: the purpose of this study was to evaluate the performance of one investigational bayer blood glucose meter (with investigational bayer test strips) and four blood glucose monitoring systems from other companies. all meter bg results were compared with plasma results obtained with a reference laboratory glucose method (ysi glucose analyzer). performance of the five systems was evaluated across the glucose range of the bgmss using capillary blood. all testing and lancing were performed by study staff and some blood samples were glycolyzed to lower the glucose levels.


Eligibility criteria:
inclusion criteria: * males and females * 18 years of age or older * willing to complete all study procedures exclusion criteria: * blood borne infections like hepatitis or hiv or infections such as tuberculosis * hemophilia or any other bleeding disorder * pregnancy
a study of erdafitinib intravesical delivery system in japanese participants with bladder cancer

Conditions: Urinary Bladder Neoplasms; Receptors, Fibroblast Growth Factor

Summary: the purpose of the study is to determine the tolerability of erdafitinib intravesical delivery system (tar-210) in japanese participants.


Eligibility criteria:
inclusion criteria: * histologically confirmed non-muscle-invasive urothelial carcinoma of the bladder * all visible tumors must be completely resected prior to the start of study treatment and documented on screening cystoscopy * confirmed recurrence of non-muscle invasive bladder cancer (nmibc) after prior therapy that meet either one: a. recurrence of high-risk nmibc (high-grade ta or any-grade t1) within 12 months after adequate bacillus calmette-guerin (bcg), or any-grade t1 within 3 months after 1st induction course, refusing or ineligible for radical cystectomy (rc). b. recurrence of intermediate- or high-risk nmibc (any-grade ta/t1) after prior bcg regardless of the timing of recurrence, refusing or ineligible for rc and considering no other effective treatment options. c. recurrence of intermediate-risk nmibc (low grade ta) after intravesical chemotherapy including maintenance therapy following a single dose after operation, no other effective intravesical chemotherapy is available and refusing bcg treatment * at least 1 of the study protocol defined activating fibroblast growth factor receptors (fgfr) mutation or fusion, as determined by local or central testing using either tumor tissue or urine sample collected prior to trans urethral resection of bladder tumour (turbt) * eastern cooperative oncology group (ecog) performance status score of less than or equal to (\<=) 2 exclusion criteria: * histologically confirmed muscle-invasive (t2 or higher stage) urothelial carcinoma of the bladder. * prior treatment with an fibroblast growth factor receptor (fgfr) inhibitor * presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe placement, indwelling use, or removal of erdafitinib intravesical delivery system * participants with active bladder stones or history of bladder stones less than \[\< 6\] months prior to the start of study treatment * participants have concurrent or second malignancy other than the disease which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s); -bladder post-void residual volume (pvr) \>350 ml after second voided urine, -current central serous retinopathy or retinal pigment epithelial detachment of any-grade
epigenetic and developmental effects of in utero exposure to environmental toxicants

Conditions: Full Term Infants; Environmental Exposures; Adiposity

Summary: metabolic diseases such as obesity and diabetes are modern day epidemics. early life exposure to an adverse developmental environment, including environmental toxins, are linked to increased susceptibility to obesity, metabolic syndrome and type 2 diabetes. although the mechanisms underlying the fetal origins of metabolic disease are poorly understood, strong evidence suggests that alterations in the epigenome play a critical role in this process. the central hypothesis of this proposal is that intrauterine exposure to benzo\[a\]pyrene leads to epigenetic changes which will have functional consequences and may be a marker for, or may contribute to, increased susceptibility to adverse outcomes in childhood including increased adiposity and the subsequent development of obesity, metabolic syndrome or diabetes. the goals of this proposal are to: 1) determine benzo\[a\]pyrene levels in umbilical cord blood of newborns, 2) determine whether benzo\[a\]pyrene exposure during pregnancy correlates with early onset of obesity and metabolic disease by examining the children at 12 and 24 months of age, 3) determine whether in utero benzo\[a\]pyrene exposure programs metabolic disease through alterations in dna methylation and gene expression, and 4) determine the plasticity of the dna methylation patterns in the same offspring at 12 months of age. the long-term goal of this project is to define biomarkers that identify neonates at "high-risk" for diminished attainment of full health potential, who can then be targeted for preventative measures.


Eligibility criteria:
inclusion criteria: * infants whose mothers were followed by the obstetric department at mmc, and * deliver a single healthy live term infant exclusion criteria: * multiple gestation, * maternal depression, * history of maternal smoking in the 3rd trimester of pregnancy, * infants in extremis, * apgar score \<7 at 5 min and umbilical artery ph ≤7.25, * chromosomal/congenital abnormalities, * congenital infections, and * inborn errors of metabolism

Keywords: term gestation environmental exposure benzo(a)pyrene polycyclic aromatic hydrocarbons adiposity cytosine methylation
dose escalation, safety and pharmacokinetic study of ave8062 combined with docetaxel in patients with advanced solid tumors

Conditions: Advanced Neoplastic Disease

Summary: primary objective: to determine the dose limiting toxicity (dlt), the maximum administered dose (mad) and the maximum tolerated dose (mtd) of ave8062 and docetaxel in combination administered sequentially on d1 \& d2 respectively every 3 weeks in patients with advanced solid tumors. secondary objectives: * to define the overall safety profile of the combination. * to characterize the pharmacokinetic (pk) profile of ave8062 and docetaxel when administered in combination. * to evaluate anti-tumor activity of the combination. * to evaluate potential predictive biomarkers. the study includes a tumoral pharmacogenomic sub-study conducted in a subset of sites. the objective to analyse a set of biological biomarkers in order to identify a potential predictive signature of efficacy for ave8062 in combination with docetaxel.

the duration of study for each patient will include 4-week screening phase prior to first inclusion of study drug, 21-day study treatment cycles, end of treatment visit and follow-up phase. each patient will be treated until disease progression, unacceptable toxicity or other study discontinuation criteria.

Eligibility criteria:
inclusion criteria: * advanced neoplastic disease (i.e metastatic or locally advanced disease) for which docetaxel-based regimen therapy is indicated such as breast, non-small cell lung and prostate cancer. * ecog performance status of 0 to 1. exclusion criteria: * concurrent treatment with any other anticancer therapy. * patient with locally advanced or metastatic breast cancer who never received adjuvant chemotherapy. * brain metastases and carcinomatous leptomeningitis. * prior intensive chemotherapy with autologous stem cell rescue. * patients who received a high cumulative dose of anthracycline (i.e doxorubicin \> 400mg/m2 or epirubicin \>750 mg/m2). * impaired cardiovascular function. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.