Kornimate/medical-research-clean huggingface dataset:
tobacco dependence treatment education for dental students

Conditions: Smoking

Summary: this study determines if there is a difference in dental students' attitudes, perceived barriers, subjective norms, perceived skills, self-efficacy, intentions to provide cessation treatment, and cessation knowledge in those students receiving a tobacco cessation lecture along with practice sessions using standardized patients and those students receiving only a tobacco cessation lecture. the study determines if dental students' use of tobacco affects their intent to provide cessation treatment to patients, and if the time between receiving the lecture and participating in the practice sessions using standardized patients makes a difference in dental students' attitudes, perceived barriers, subjective norms. perceived skills, self-efficacy, intentions to provide cessation treatment, and cessation knowledge.

the experimental study has a pretest-posttest design. it evaluates the changes to dental students' attitudes, perceived barriers, subjective norms, perceived skills, self-efficacy, intentions to provide cessation treatment, and tobacco cessation knowledge between those students receiving a lecture along with practice sessions using standardized patients and those students receiving only a lecture. dental students will be invited to complete two questionnaires. the control group of dental students will complete the first questionnaire before the lecture and the second questionnaire after the lecture. the experimental group of dental students will complete the first questionnaire before the lecture and the second questionnaire after the lecture and the practice and debriefing sessions. subjects will include 120 first year dental students in an introductory course to clinical dentistry. the cessation training is a required activity in the course. students are divided into small groups according to their bench or lab numbers. these numbers are assigned to the student based on the alphabetical order of their name. the eligibility criteria is: 1) must be a first year dental student in introduction to clinical dentistry 1 at the university of louisville, and 2) must be willing to volunteer to complete pre- and post-questionnaires about the cessation treatment educational program. the exclusion criteria is: subject is not willing to give consent to complete the pre- and post- questionnaire.

Eligibility criteria:
inclusion criteria: * must be a first year dental student in introduction to clinical dentistry i at the study institution * volunteer to complete pre- and post-questionnaires concerning tobacco cessation treatment educational training. exclusion criteria: * subject does not complete pre- and post- questionnaires.

Keywords: tobacco cessation treatment standardized patients dental students tobacco cessation treatment education
effect of deep brain stimulation (dbs) on sleep architecture in patients with movement disorders

Conditions: Parkinson's Disease; Tremor; Dystonia

Summary: the purpose of this prospective, participant-blinded trial is to determine the changes in sleep architecture in a cohort of subjects who have undergone deep brain stimulation (dbs) surgery for treatment of movement disorders such as moderate to advanced parkinson's disease (pd), tremor, or dystonia. our preliminary observational data suggest that unilateral subthalamic nucleus (stn) dbs improves subjective sleep quality in pd patients 6 months after the procedure. the cause of this improvement in sleep quality is unknown, and this study proposes the use of polysomnography (psg) to test whether the improvement in sleep is independent of improvement in night-time mobility associated with dbs treatment of the motor symptoms of pd, tremor, or dystonia.


Eligibility criteria:
inclusion criteria: * prior dbs surgery for treatment of movement disorders such as pd, tremor, or dystonia. * stable dbs stimulator settings and medication regimen for at least 6 weeks prior to the sleep studies. * sleep dysfunction as measured by the pittsburgh sleep quality index (psqi) (score \>5) at the subject's baseline pre-surgical evaluation. exclusion criteria: * known narcolepsy * other previous surgical treatment of parkinson's disease, tremor, or dystonia (with the exception of dbs) including pallidotomy, thalamotomy, or gene therapy procedures. * untreated obstructive sleep apnea. if obstructive sleep apnea is discovered during the first sleep study, the subject will be removed from the study. after they have been treated for at least 6 weeks with cpap, they can re-start the study.

Keywords: parkinson's disease tremor dystonia dbs sleep
comparison of morning and evening dosing of valsartan and lisinopril in patients with diabetes

Conditions: Hypertension

Summary: a study comparing the antihypertensives valsartan and lisinporil when doses are in the morning and comparing a morning dose of valsartan with an evening dose.


Eligibility criteria:
inclusion criteria: - hypertension defined by a mssbp \>=150 mmhg (untreated patients) or patients on current anti-hypertensive treatment who remain uncontrolled (i.e. mssbp \>140 mmhg) * randomisation mean 24h blood pressure above 130/80 mmhg * in addition the patients must fulfill, at least, one of the following criteria: controlled type ii diabetes mellitus hypercholesteremia, currently treated with lipid-lowering drugs metabolic syndrome mi, cabg or ptca more than one year ago stroke or transient ischemic cerebral attack more than one year ago documented history of peripheral vascular disease, increased imt, or carotid plaques documented history of lvh elderly \>65 years exclusion criteria: * - mssbp \>=180 mmhg and/or msdbp \>= 110 mmhg at any time from visit 1 to visit 3 * inability to discontinue all prior anti-hypertensive medications safely for a period of three weeks * mandatory indication for any concomitant medication for coronary artery disease or any other disease that is not allowed during this study. other protocol-defined exclusion criteria may apply.

Keywords: hypertension valsartan morning/evening dosing lisinopril
description of the short-term effects of kaftrio® by continuous monitoring with the pheal-cr-k application in real life in patients with cystic fibrosis eligible for kaftrio® treatment

Conditions: Cystic Fibrosis

Summary: this is a prospective, open-label, multicenter study (1 year) with 50 patients with cystic fibrosis for whom treatment with kaftrio® is prescribed.cystic fibrosis is a rare autosomal recessive hereditary disease linked to a mutation of the cftr (cystic fibrosis transmembrane regulator) protein gene. for the majority of patients, no treatment with a cftr protein modulator was available until the arrival of the kaftrio® triple therapy (ivacaftor/tezacaftor/elexacaftor). clinical studies on this triple therapy demonstrate significant improvements in fev (forced vital capacity) and also very rapid health improvement of patients. however, there is a lack of data recorded in real life at home by patients to trace the evolution curves of health parameters and patient perceptions from the first days after initiation of treatment. the pheal-cr-k application, specially developed for the study, makes it possible to collect physiological parameters and perceptions collected via connected objects or declared manually in the application. these data will reflect the evolution of the parameters from the start of the treatment and over a period of 3 months. in addition, the composition of volatile organic compounds (vocs) of the air exhaled in the early phase of treatment with kaftrio® will be monitored for the group of patients followed at foch hospital. exhaled air is an ideal biological fluid for clinical monitoring (non-invasive collection and real-time analysis). in cystic fibrosis, biomarkers in the exhaled air have been correlated with functional and clinical parameters. the objective is to collect the air exhaled before initiating treatment with kaftrio® and during treatment, to identify vocs whose expression would be modified early. changes in the composition of the exhaled air will be correlated with follow-up clinical data collected with the pheal-cr-k application and with functional data obtained during measurements of breath by spirometry (fev) and sweat concentrations of chloride ions collected at the during a sweat test. the identified covs could become early predictive biomarkers of clinical response.


Eligibility criteria:
inclusion criteria: * patients aged 18 and over * patients with cystic fibrosis eligible for kaftrio® * patients for which kaftrio® treatment is prescribed, including patients previously treated with other cftr modulators (orkambi®, kalydeco®, symkevi®) * patients who signed the informed consent form * patients affiliated to a health insurance plan * patients equipped with a smartphone and having a wifi connection at home exclusion criteria: * pregnant or breastfeeding women * patient who does not speak or understand french * patient deprived of liberty or under guardianship
the impact of free fatty acid (ffa-) suppression on myocardial lipids and function in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: there is evidence that inhibition of ffa-release by acipimox is associated with a significant decrease in myocardial lipid content (mycl) as well as the ejection fraction (as a marker of systolic left ventricular function) in healthy subjects, indicating, that the heart is dependent on a constant supply of free fatty acids in order to guarantee normal cardiac function, and it further indicates, that the heart is not able to cover its energy demand by switching to glucose oxidation. since that phenomenon, better known as "metabolic inflexibility" has been mainly described in patients with diabetes, we aim to investigate the impact of ffa-inhibition on mycl and cardiac function in patients with overt type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hba1c \>6% exclusion criteria: * insulin therapy (except: bot=basal supported oral therapy) * known heart disease including coronary artery disease, cardiomyopathy, history of cardiac surgery * known intolerance against niacins * known contra-indications against magnetic resonance (mr-) examinations
dazucorilant in patients with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of this study is to assess the safety and efficacy of cort113176 (dazucorilant) in patients with amyotrophic lateral sclerosis (als).

eligible als patients will be randomized to one of three treatment arms (1:1:1) across north america and europe for a 24-week double-blind treatment period. patients who complete participation (i.e., completed all visits) in the double-blind treatment period will be eligible for participation in a 132-week open-label extension (ole) study. a daily dose of 300 mg dazucorilant will be used in the 132-week ole period. patients that complete the double-blind treatment period and who do not enter the ole will enter the 132-week follow-up period.

Eligibility criteria:
inclusion criteria: * male and female patients ≥18 years of age with sporadic or familial als * if taking riluzole, edaravone, and/or sodium phenylbutyrate and taurursodiol, must be on a stable dose prior to screening. exclusion criteria: * history of a clinically significant non-als neurologic disorder * inability to swallow capsules. * human immunodeficiency virus (hiv) or current chronic/active infection with hepatitis c virus or hepatitis b virus * women who are pregnant, planning to become pregnant, or are breastfeeding. * use of non-invasive ventilation (niv) or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation. * current or anticipated need of a diaphragm pacing system (dps). * currently using glucocorticoids or have a history of regular systemic glucocorticoid use within the last 12 months. * previous exposure or treatment with glucocorticoid receptor modulators or antagonists.

Keywords: als, amyotrophic lateral sclerosis
use of meopa (equimolar mixture of nitrogen protoxide and oxygen) for elderly with dementia

Conditions: Dementia

Summary: acute pain is frequent in elderly especially in geriatrics acute care units where painful procedures are often occurring. meopa represents an alternative to opioïd therapy to prevent procedural pain during the treatment of pressure ulcers. in this study, cognitive impairment and dementia do not limit the use of meopa. the new approach in the management of acute procedural pain provides effective and safe analgesia in frail old patients.


Eligibility criteria:
inclusion criteria: * dementia (folstein scoring between 0 and 25) * older than 75 * health necessitating of painful care for example eschar care exclusion criteria: * bullous emphysema * pneumothorax

Keywords: acute pain meopa dementia
a phase 1 clinical study to evaluate the effects of shr7280 on the pharmacokinetics of midazolam, s-warfarin, omeprazole, digoxin, and rosuvastatin in healthy subjects

Conditions: Endometriosis; Uterine Fibroids; Assisted Reproduction

Summary: the purpose of this study is to evaluate the effects of shr7280 on the pharmacokinetics of midazolam, s-warfarin, omeprazole, digoxin and rosuvastatin in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol. 2. males aged 18-45 years (inclusive). 3. subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ecg). 4. weight ≥ 50 kg and body mass index (bmi) : 19-26 kg/m2 (inclusive). 5. informed consent was obtained and patients did not plan to have children within 3 months after the last dose of medication, and they agreed to use highly effective contraception. exclusion criteria: 1. those with clinically significant abnormalities in physical examination, vital signs (respiration, temperature, pulse), other laboratory tests, chest imaging, abdominal ultrasound, etc. 2. hepatitis b surface antigen (hbsag), hepatitis c virus (hcv) antibody, human immunodeficiency virus (hiv) antibody and syphilis antibody positive. 3. patients with any previous diseases that increase the risk of bleeding. 4. patients with previous chronic or severe medical history or existing diseases of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, and mental system, who were judged by the investigators to be not suitable for the trial. 5. history of blood donation or blood loss ≥ 400 ml or blood transfusion within 3 month before screening. 6. subjects with other factors considered by the investigator to be ineligible for the study.
safety and efficacy of workflows of high volume single operators in a laao device implant procedural day

Conditions: Atrial Fibrillation

Summary: safe hv is an observational, prospective, multi-center, non-randomized study evaluating real-world clinical experience of centers where a single procedural physician schedules eight or more left atrial appendage occlusion (laao) device implant procedures in a single calendar day.

since 2009, watchman flx™ and its predecessor, watchman™ have provided a safe and effective alternative to oral anticoagulation for over 200,000 patients in the united states and europe. advancements in the design of the watchman flx™ have made the device available to a wider range of patients. as more patients qualify for the device, more implant procedures are necessary to provide them with this life-changing treatment option. some watchman flx™ implanters perform high volumes of implant procedures on certain days. while performing a high-volume of implant procedures is desirable for many reasons, it must be determined that cases performed under such circumstances are comparable in safety and efficacy to implant procedures performed at lower volumes. while there has been no differentiation between high and low volume cases in previous studies, data obtained in this study will be compared to overall safety and efficacy data available from the pinnacle flx clinical trial and the surpass analysis to ensure that safety and efficacy outcomes are comparable. additionally, this study will collect data on the workflows of these high-volume implanters that will help determine which factors contribute to the successful performance of high volumes of watchman flx™ implants in a single day. in the future this information may be used to help other implanters optimize workflows to increase their volume of daily implants and hence, provide more opportunities for patients to access this transformative device.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. able and willing to participate in baseline and follow up evaluations for the full length of the study 3. clinically qualified, in the opinion of the investigator, to receive a laao device 4. receiving a watchman flx™ or watchman flx pro™ laao device as part of their plan of care 5. having their laao device implant procedure scheduled on a qualifying high-volume\* procedure day as assessed within 2 days (≤ 2 calendar days) prior to the planned procedure date \*high-volume - a calendar day in which the single implanting physician schedules ≥ 8 laao device implant procedures, regardless of the device manufacturer 6. willing and able to provide informed consent exclusion criteria: 1. enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan 2. in the opinion of the investigator, any known contraindication to a laao device or implant procedure 3. having their laao device implant procedure scheduled on a day in which the single implanting physician scheduled \< 8 laao device implant procedures as assessed within 2 days (≤ 2 calendar days) prior to the planned procedure date
a study of the efficacy and safety of omalizumab through 48 weeks in participants with chronic idiopathic urticaria

Conditions: Urticaria

Summary: this multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of subcutaneous (sc) omalizumab (xolair) as an add-on therapy through 48 weeks for treatment of h1 antihistamine refractory chronic idiopathic urticaria (ciu). after completing an initial 24-week open-label treatment period with omalizumab 300 milligrams (mg) every 4 weeks (q4w), participants responding to omalizumab will be randomized at a 3:2 ratio (omalizumab:placebo) to either continue omalizumab or be transitioned to placebo for a further 24 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of ciu refractory to h1 antihistamines at baseline * presence of itch and hives for at least 8 consecutive weeks at any time prior to enrollment despite current use of h1 antihistamine treatment (up to four times the approved dose) during this time period * uas7 score (range 0-42) ≥ 16 and itch component of uas7 (range 0-21) ≥ 8 during 7 days prior to baseline * participants must have been on a non-sedating h1 antihistamine treatment (up to four times the approved dose) for ciu for at least 3 consecutive days immediately prior to screening visit with continued current use on the day of the initial screening visit * ciu diagnosis for ≥ 6 months * willing and able to complete a daily symptom ediary for the duration of the study exclusion criteria: * treatment with an investigational agent within 30 days of the initial screening visit * body weight less than 20 kilograms * clearly defined underlying etiology for chronic urticarias other than ciu * evidence of a parasitic infection * atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch * previous treatment with omalizumab within 1 year prior to the initial screening visit * participants may not have taken during treatment period or have been taking within 30 days before the initial screening visit any of the following medications or treatments: regular (daily/every other day during 5 or more consecutive days) systemic corticosteroids, hydroxychloroquine, methotrexate, mycophenolate, cyclosporine, cyclophosphamide, intravenous immunoglobulin g or plasmapheresis * regular (daily/every other day) oral doxepin use within 14 days prior to the initial screening visit * pregnant or lactating women, or women intending to become pregnant during the study
progesterone effect on individuals diagnoses with ad and ptsd.

Conditions: Alcohol Dependence; Post-Traumatic Stress Disorder (PTSD)

Summary: this is a randomized control trial with an anticipated 36 participants diagnosed with post-traumatic stress disorder (ptsd) and comorbid alcohol dependence. participants will be randomized to receive either progesterone (200 mg. bid) or placebo in identical looking capsules for three days. one goal of this research study is to test if progesterone is more effective than placebo in reducing craving after exposure to trauma cues and alcohol cues in a laboratory paradigm among men and women with ad and ptsd. we hypothesize that progesterone in comparison to placebo will significantly reduce craving for alcohol in response to trauma cues alone and in combination with alcohol cues in individuals with ad and ptsd. a second goal is to examine if there are gender differences in progesterone effects on stress and alcohol cue-induced craving. we hypothesize that the effects of progesterone on stress and craving will be stronger in women than in men. participants will be recruited primarily through advertisement, but also through the clinical facilities at the va and from other collaborators.


Eligibility criteria:
inclusion criteria: 1. men and women ages 21 to 60; 2. current diagnosis of ad and ptsd; 3. drink regularly are not in an active phase of alcohol withdrawal; 4. not at risk for suicide; 5. not taking regularly psychoactive drugs including anxiolytics and antidepressants; 6. for women, have regular menses every 25-35 days. exclusion criteria: 1. current scid diagnosis of any psychotic disorder; 2. substance dependence (other than alcohol and nicotine) in the past 30 days; 3. current unstable medical condition; 4. positive test results at more than one baseline appointment on urine drug screens conducted for opiates, cocaine, marijuana, benzodiazepines, and barbiturates; for women, amenorrhea, use of oral contraceptives; 5. known allergy to progesterone or peanuts (vehicle for micronized progesterone); 6. history of thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes or history of stroke.

Keywords: alcohol dependence post-traumatic stress disorder (ptsd) progesterone