Kornimate/medical-research-clean huggingface dataset:
toujeo versus nph self-titration study

Conditions: Diabetes Mellitus, Type 2

Summary: this is a 24 week, multicentre, prospective, randomized, controlled, parallel-designed (1:1) pilot study.the study will compare glycemic variability in patients treated with insulin glargine u300/ml insulin versus conventional (nph) insulin using a self titration algorithm.50 type 2 diabetes patients who are newly started on insulin will be recruited. they will be randomly allocated to either insulin glargine u300 or nph insulin for 26 weeks. all subjects will follow a insulin-self titration algorithm. the study will consist of 9 visits over 26 weeks. blood glucose variability will be collected by cgm for 7 consecutive days at baseline (week -1) and at week 24.secondary endpoints other than data on glycemic variability, including hba1c, fasting plasma glucose, inflammatory markers will be measured during three periods (week 0, week 12 and week 24).


Eligibility criteria:
inclusion criteria: * type 2 diabetic suboptimally controlled on their previous antidiabetic treatment * 18 ≤ age ≤ 75 * stable dose of oral antidiabetic treatment for \> 8 weeks * the number of oads that the patients used should be "3" or less * hba1c level \> 7.0% and \< 10% * fasting plasma glucose \> 8mmol/l and \<15mmol * bmi \< 40 kg/m2 * patient who is capable and willing to perform regular smbg * patient who is capable and willing for insulin injection * confirmed written consent * insulin naïve exclusion criteria: * participation in a clinical trial with any investigational drug used with curative intent and within 30 days prior to study entry * patient known to have hypoglycaemia unawareness or recurrent major hypoglycaemia * any product containing prandial insulin * concomitant medication known to interface with glucose metabolism (such as systematic steroids) * change in dose of non-insulin anti-diabetic treatment or initiation of new anti-diabetic medications in the last 8 weeks prior to screening * patients treated with steroid or nonsteroidal anti-inflammatory drugs * patient who had experienced an acute concurrent illness during the 3-month period before the investigation * patient with hepatic disease and end-stage renal disease * patients unable to comply with follow-up visits * pregnant or breastfeeding women
a study of ro5036505 in patients with moderate to severe asthma

Conditions: Asthma

Summary: this randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of ro5036505 in patients with inadequately controlled moderate to severe asthma. patients will be randomized to receive either ro5036505 (380mg iv infusion once weekly) or placebo for 8 weeks. patients will be on a standardized inhaled corticosteroid/long-acting beta-agonist regimen during study treatment. target sample size is 50-100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-70 years of age * moderate to severe asthma for \>/=2 years * acq score \>/= 1.5 * ics and laba regimen at moderate to high dose * non-smokers exclusion criteria: * oral corticosteroid use within 4 weeks prior to screening * current escalating immunotherapy * acute infection/antibiotic therapy within 4 weeks prior to screening, or chronic infection * pulmonary disease other than asthma * therapy with any approved monoclonal antibody or biologic agent within 12 months prior to screening * previous exposure to investigational monoclonal antibodies or biologics
the effect of television watching on liking of food

Conditions: Hunger

Summary: the purpose of the study is to investigate the effect of television viewing on liking of food.

the objective of this investigation is to determine whether participants will have a change of liking of food based on television viewing. the specific aims of the study are: 1. determine the effect of television on liking of food. 2. determine the effect of no television on liking of food.

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 35 years * body mass index (bmi) between 18.5 kg/m2 and 24.9 kg/m2 * unrestrained eater (≤ 12 on the three factor eating questionnaire \[tfeq-r\]) * report a favorable preference for foods served in the meal including: macaroni and cheese and salad (dressing will be chosen by the participant via initial phone screen), participants must rate each food item ≥ 3 during phone screen and ≥ 50 on a visual analogue scale (vas) during the initial screening session * regularly eat a meal before 10:00 am * are able to complete all sessions within eight weeks of the screening session * report being a non-smoker * are not taking medications that affect appetite or food intake * are not pregnant or breastfeeding * are not on a dietary plan or have dietary restrictions that prevent consumption of certain types and/or amounts of food exclusion criteria: * binge eating; and/or * athletes in training

Keywords: lunch television macaroni and cheese salad tossed in dressing
endobiliary percutaneous cryobiopsy in malignant biliary obstruction

Conditions: Biliary Tract Carcinoma; Biliary Obstruction

Summary: the rationale of the study is to explore the safety and efficacy of percutaneously performed endobiliary cryobiopsy in patiens with histologically unverified biliary stenosis.

in patients with malignant biliary stenosis in whom endoscopic retrograde cholangiography (ercp) is not feasible , percutaneous transhepatic drainage (ptd) is indicated. biopsy is required for further management of the patient. in patients unsuitable for biopsy under ct or endoscopic guidance, samples can be collected endobiliary by ptd. the biopsy vie ptd can be sampled either at the initial drainage using disposable 5.2f forceps or delayed after 2 or more days using 7.5f endobiliary forceps. an alternative to this procedure is endobiliary sampling by cryobiopsy using 1.1mm, 1.7mm or 2.4mm catheters. to minimize bias, each patient will be sampled both by cryobiopsy and forceps biopsy. the order of cryobiopsy and forceps biopsy will be randomized.

Eligibility criteria:
inclusion criteria: * biliary stenosis of unknown etiology * unsuccessful or unfeasable ercp * indicated percutaneous transhepatic drainage exclusion criteria: * histologically verified biliary stenosis * inr ≥ 1,5

Keywords: cryobiopsy biliary obstruction percutaneous transhepatic drainage
change in hygiene and sugar comsuption habits after use of cognitive behavioral therapy in pediatric dentistry in twins

Conditions: Oral Manifestations; Child Behavior; Adolescent Behavior; Change; Cognitive

Summary: the objective of this study is to verify the changing habits and their maintenance after using cognitive behavioral therapy, exploring factors that may be associated with these stages and the moment in which they occur.

the objective of this clinical trial is to verify the time until changing habits and their maintenance after using cognitive behavioral therapy, exploring the following factors that may be associated with these stages and the moment in which they occur: * evaluate the cost-effectiveness of guidance based on cognitive behavioral therapy in relation to changes aimed at oral hygiene and diet habits, through a before and after study; * investigate individual and contextual preferences associated with adherence and maintenance of behaviors associated with oral health (diet and oral hygiene) through a discrete choice experiment (dce) * measure the effect of retaining hygiene and diet guidance on pairs who did not submit the calendar and on those who submitted the calendar.

Eligibility criteria:
inclusion criteria: * twin children born at the hospital de clínicas de são paulo between 2007 and 2014; * children whose mothers were followed up at the multiple pregnancy unit; * guardians who sign the informed consent form; * children who sign the assent form. exclusion criteria: * children whose families that cannot be contacted by phone call, email, or social media; * children with medical or psychological conditions that prevent safe participation in the dental research.

Keywords: clinical study cognitive behavioral therapy oral health twins motivational guidance preference patients
mental health in veterans and families after group therapies

Conditions: Post-Traumatic Stress Disorders

Summary: ptsd (posttraumatic stress disorder) and associated mental health conditions affect both veterans and their family members. this study investigates whether group therapy using eft (emotional freedom techniques) and cbt (cognitive behavior therapy) produce reductions in ptsd and comorbid symptoms.


Eligibility criteria:
inclusion criteria: * the ability to follow instructions, complete written forms, and provide informed consent. subjects are required to be literate and understand english. * physically healthy. * active duty military service, veterans, and their family members. exclusion criteria: * none
hypofractionated radiation therapy to improve immunotherapy response in non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer Metastatic

Summary: this study includes the additional use of radiation therapy in combination immunotherapy in order to determine whether the radiation may improve the response of non-small cell lung cancer to immunotherapy and to monitor any side effects.

preclinical data suggest that radiation therapy may be uniquely suited to combine with immune checkpoint inhibitors, since radiation can disrupt a tumor's physical barriers to t-cell infiltration and augment antigen presentation, thus serving as an "in situ personalized vaccine" to activate the immune system and potentially enhance the systemic response. the rationale for this study is to determine the safety and efficacy of combined immune checkpoint inhibitors and radiation therapy in metastatic non-small cell lung cancer patients.

Eligibility criteria:
inclusion criteria: * stage iv metastatic non small cell lung cancer * measurable disease of at least 1.5 cm in greatest dimension at least 2 non-irradiated sites (except for lymph nodes, in which the short-axis dimension must be at least 1.5cm). there must be at least 1 visceral organ metastasis outside of the brain. * history of prior cytotoxic chemotherapy (with or without concomitant radiation therapy) with subsequent distant (metastatic) disease relapse, or progression of disease while on chemotherapy. * participant must be planned to receive (or actively receiving) standard of care checkpoint inhibitor immune therapy. for those patients actively receiving checkpoint inhibitor immune therapy the duration of immune therapy at the time of enrollment must be 4 months or less. * life expectancy greater than 3 months exclusion criteria: * active autoimmune disease, primary immunodeficiency syndrome, hiv/aids, or hepatitis b or c * oral corticosteroid dependency * uncontrolled or untreated active brain metastases/cns disease * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia

Keywords: nsclc lung cancer non small cell lung cancer
a study of ly2951742 in participants with mild to moderate osteoarthritis knee pain

Conditions: Osteoarthritis, Knee

Summary: the main purpose of this study is to test if ly2951742 relieves mild to moderate knee pain. the study drugs will be given as an injection under the skin and as an oral capsule. the study will last about 28 weeks for each participant.


Eligibility criteria:
inclusion criteria: * have osteoarthritis (oa) of the knee joint based on american college of rheumatology (acr) criteria and confirmed with x-rays and acr functional class of i to iii * have been on stable dose of prescription nonsteroidal anti-inflammatory drugs (nsaids), celecoxib, tramadol, or acetaminophen of at least 2000 mg per day for at least 20 days in the past month * willing to stop all analgesics for oa pain during the study * experienced pain while walking in the target knee of 50-90 mm inclusive on 0-100 visual analog scale (vas) with an increase in pain while walking of at least 10 mm following washout of current osteoarthritis pain medications at screening exclusion criteria: * allergic to ly2951742, celecoxib, other nsaids, including aspirin, and similar drugs * arthritis of the knee from other causes * uncontrolled hypertension * have oa pain that requires treatment with potent opioids, systemic corticosteroids, intra-articular injections, duloxetine, or venlafaxine * moderate to severe renal impairment * pregnant or lactating
interest of circulating tumor dna in digestive and gynecologic/breast cancer

Conditions: Breast Cancer; Digestive Cancer; Gynecologic Cancer; Circulating Tumor DNA; Exosomes

Summary: circulating tumor dna (ctdna) offers the possibility of accessing the tumor genome from circulating blood through a simple blood test. it is currently used for diagnostic, prognostic and predictive purposes of response or resistance to oncological treatments. these advances in ctdna have been made possible by major developments in molecular biology techniques in recent years, as the detection of ctdna requires very sensitive techniques such as next generation sequencing (ngs). ctdna overcomes this problem of very limiting tumor heterogeneity during a solid biopsy. all of these applications make circulating dna an increasingly essential tool in the management of cancer patients. the studies are currently in most cases on small numbers and are retrospective. in addition, exosomes are also a biomarker of the future that can also be detected in the bloodstream . exosomes are nanovesicles 50 to 200 nm in diameter released into the extracellular environment via the endosomal pathway by fusion with the plasma membrane. they are very informative since they transport tumor genetic material in the form of dna, mrna and mirna, but also adhesion proteins, immunostimulatory molecules and cytoskeleton, enzymes and heats shock proteins ( hsp). the aim of the adigyn study is to set up a large prospective cohort to assess the diagnostic, prognostic and predictive impact of ctdna and exosomes in digestive and gynecological / breast cancers. from the circulating dna, we characterize the actdna on the molecular level thanks to the study of different point mutations usually used but also of new described mutations having a therapeutic impact and the search for other genetic alterations having an impact on the therapeutic strategy (such as microsatellite instability) or the study of exosomes and their composition. to assess resistance to oncological treatments, ctdna will be analyzed at the start of treatment, during treatment, during progression and / or relapse and also during monitoring or treatment break


Eligibility criteria:
inclusion criteria: * digestive or gynecological / breast cancer proven or suspected, requiring oncological treatment (chemotherapy or immunotherapy) * major patient * patients benefiting from a social security scheme or benefiting through the intermediary of a third party * information note and collection of non-opposition after clear and fair information about the study exclusion criteria: * linguistic or psychological refusal or inability to understand and / or sign the information and no-objection note * history of a cancer other than that allowing inclusion in the 5 years preceding inclusion
efficacy, safety and tolerability of high lipid and calorie supplementation in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: the primary objective of the trial is to investigate the survival time (the time from randomization until death or date of end of the study) compared between control group and experimental group. this is a prospective, multicenter, randomized, stratified, parallel-group, double-blind trial comparing placebo with high caloric fatty diet for drinking as add-on therapy to 100 mg riluzole in amyotrophic lateral sclerosis (als) in 200 enrolled patients. for entry, the el escorial criteria for the diagnosis of als will be used. the patients have to be stable on riluzole at least 4 weeks prior to randomization.


Eligibility criteria:
inclusion criteria: * possible, probable (clinically or laboratory supported) or definite als according to the revised version of the el escorial criteria (brooks et al. 2000) * disease duration \< 36 months * vital capacity of more than 50% of normal (defined as slow vital capacity, best of three measurements) * age ≥18 years * continuously treated with 100 mg riluzole daily for at least four weeks * capable of thoroughly understanding all information given and giving full informed consent according to gcp * willing to complete a diet questionnaire throughout participation in the study exclusion criteria: * simultaneous participation in another interventional clinical study * previous participation in a drug clinical trial where last intake of the trial drug was within the last 12 weeks * known sensitivity or intolerance to rape oil or sunflower oil, or components thereof * tracheostomy * patients with gastrostomy * pregnancy or breastfeeding * any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of als * presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment. * evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms. * liable to be not cooperative or comply with study requirements as assessed by the investigator, or unable to be reached in the case of emergency.

Keywords: amyotrophic lateral sclerosis survival time als functional rating scale quality of life survival
rollover study of ivacaftor in subjects with cystic fibrosis and a non g551d cftr mutation

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the safety of long-term ivacaftor treatment in participants with cystic fibrosis (cf) from studies 110 (nct01614457), 111 (nct01614470), and 113 (nct01685801).

ivacaftor is the first cystic fibrosis transmembrane conductance regulator (cftr) modulator to show an improvement in cftr function and clinical benefit in participants with cf. results from phase 3 studies (nct00909532 \[study 102\] and nct00909727 \[study 103\]) showed that ivacaftor is effective in the treatment of participants with cf who have the g551d-cftr mutation, as evidenced by sustained improvements in cftr channel function (measured by reduction in sweat chloride concentration) and corresponding substantial, durable improvements in lung function, pulmonary exacerbations, respiratory symptoms, and weight gain. ivacaftor was also well tolerated, as evidenced by the rates and reasons for premature discontinuation and results of safety assessments. ivacaftor (trade name kalydeco; 150 mg tablets) was initially approved in the united states for the treatment of cf in participants 6 years of age and older who have a g551d mutation in the cftr gene.

Eligibility criteria:
inclusion criteria: * participants from study 110 or study 111 entering the ivacaftor arm must have completed the assigned study drug treatment duration in the previous study. * participants from study 113 entering the ivacaftor arm must have completed all study related treatments through the follow-up visit and met the study 113 responder criteria during the previous study. * participants entering the observational arm must have completed at least 4 weeks of study drug treatment in their previous study (study 110 or study 111), must have completed the previous study but do not wish to enroll in the ivacaftor arm, or must have completed the previous study but do not meet the inclusion criteria of the ivacaftor arm. * participants of childbearing potential entering the ivacaftor arm must not be pregnant. * participants entering the ivacaftor arm must be willing to comply with contraception requirements. exclusion criteria (ivacaftor arm only): * history of any illness or condition that might confound the results of the study or pose an additional risk in administering ivacaftor to the participant. * use of moderate or strong inhibitors or inducers of cytochrome p450 (cyp) 3a. * evidence of cataract or lens opacity at or before the day 1 visit.
transauricular vagal nerve stimulation improves postoperative delirium in elderly patients

Conditions: Vagus Nerve Stimulation

Summary: to investigate the efficacy and safety of perioperative transauricular vagal nerve stimulation in improving postoperative delirium in elderly patients undergoing elective surgery lay the groundwork for a phase iii study.

this study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of transauricular vagal nerve stimulation(tavns) to improve the incidence of postoperative delirium(pod) in elderly patients undergoing anesthesia surgery. the intervention group will receive tavns, while the control group will only wear a tavns stimulator without current stimulation.

Eligibility criteria:
inclusion criteria: * age≥65 years * expected operation time≥ 2 hours * postoperative hospital stay≥ 4 days * sign the informed consent form exclusion criteria: * neurosurgery or cardiac surgery * emergency surgery within 6 hours of admission * end-stage disease with an expected survival of \< 3 months * preoperative severe cognitive dysfunction affected perioperative cognitive function assessment * severe sinus bradycardia, avb of degree ii and above, pacemaker placement
cerebrospinal fluid immune microenvironment mechanism in anaplastic lymphoma kinase positive lung cancer patients

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this is an an interventional study to explore the mechanism of cerebrospinal fluid immune microenvironment in patients with advanced anaplastic lymphoma kinase (alk)-positive non-small cell lung cancer with brain metastases treated with iruplinalib.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of advanced non-small cell lung cancer(nsclc) that is anaplastic lymphoma kinase (alk)-postive as assessed by the next-generation sequencing (ngs) test. * confirmed diagnosis of brain metastases or suspected brain metastases * iruplinalib is proposed for treatment * eastern cooperative oncology group(ecog) performance status of 0-1 * adequate organ and marrow function exclusion criteria: * have serious gastrointestinal disease or other uncontrolled internal diseases and infections * the presence of mental illness or substance abuse at the time of screening that may have affected compliance with the trial * the presence of pleural fluid or ascites that requires treatment or is judged by the investigator to be uncontrollable at the time of screening * arterial/venous thrombosis events occurred within 6 months prior to administration, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism
thalassemia screening by third generation sequencing

Conditions: Thalassemia Trait; Thalassemia; Mixed

Summary: test globin gene in participants

recruit individuals who documented as thalassemia carrier or disease and who positive thalassemia screening but unknown mutation. blood will be sent for third generation sequencing to review alpha and beta globin gene mutation.

Eligibility criteria:
inclusion criteria: 1. thalassemia carriers or disease individuals with documented as known globin gene mutation. 2. thalassemia carriers or disease individuals whose mutation did not retrieve from conventional technique and were assigned as no known mutation exclusion criteria: -incomplete medical data