Kornimate/medical-research-clean huggingface dataset:
to study generic fluticasone propionate inhalation aerosol for the treatment of bronchial asthma

Conditions: Bronchial Asthma

Summary: this is a randomized, assessor-blind, placebo controlled, multicenter, clinical endpoint bioequivalence study to compare the efficacy and safety of generic fluticasone propionate inhalation aerosol usp 44 mcg (glenmark pharmaceuticals ltd) to flovent hfa (fluticasone propionate inhalation aerosol) 44 mcg (gsk group of companies) in treatment of patients with bronchial asthma.


Eligibility criteria:
inclusion criteria: 1. adult male or female subjects aged between 18 to 65 years of age (both ages inclusive) 2. diagnosis of asthma for at least 12 months prior to screening 3. pre-bronchodilator fev1 of more than or equal to 45 % and less than or equal to 85 %. 4. subjects should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to screening 5. currently non-smoking; 6. more than or equal to 15 % reversibility of fev1 within 30 min following 360 mcg of albuterol/salbutamol inhalation (pmdi) at screening 7. ability to discontinue their asthma controller medication safely 8. ability to replace short-acting β agonists (sabas) ongoing at screening with albuterol/salbutamol inhaler. 9. women of childbearing potential must be willing to consistently use an appropriate method of contraception. 10. willingness to give their written informed consent to participate in the study. 11. is willing to comply with all aspects of the protocol. 12. ability to follow training given for study related procedures and assessments in the opinion of the investigator. exclusion criteria: 1. patients with life-threatening asthma, 2. significant respiratory disease other than asthma 3. evidence or history of clinically significant medical, surgical or psychiatric disease or laboratory abnormalities. 4. known hypersensitivity to any sympathomimetic drug. 5. subjects receiving β2-blockers, anti-arrhythmics, anti-depressants, and/or monoamine oxidase inhibitors within 4 weeks prior to the screening. 6. viral or bacterial, upper or lower respiratory tract infection, or sinus, or middle ear infection within 4 weeks prior to the screening visit 7. subjects who required biologic agents for asthma systemic or oral corticosteroids (for any reason), within the past 6 months prior to screening 8. evidence or history of oral candidiasis, active tuberculosis, hypercorticism, adrenal suppression, or eye problems. 9. female subjects who are pregnant or breast-feeding or planning to be pregnant. 10. currently enrolled in another clinical study or used any investigational product (study drug), study drug, or device within 30 days or 5 elimination half-lives, whichever is longer, preceding informed consent. 11. consumes excessive amounts of alcohol, abuses drugs, or has any condition that would compromise compliance with this protocol.
biopsychosocial predictors of nicotine relapse

Conditions: Smoking; Smoking Cessation; Nicotine Addiction; Tobacco Smoking Behavior

Summary: this study aims to investigate the associations between emotion regulation ability, stress-induced neural activity changes, and susceptibility to relapse in smokers attempting to quit. participants will undergo assessments of emotion regulation, neural activity via quantitative electroencephalography (qeeg), and stress responses before and during a 24-hour nicotine abstinence period. they will then participate in a computerized smoking cessation intervention, and their abstinence status will be monitored for 6 months.

the study will examine the unique and interactive effects of emotion regulation ability (a trait-like vulnerability factor) and biomarkers of stress responses (emotion regulation and neural activation changes) prior to smoking cessation, on cravings, abstinence adherence, and response to a smoking cessation intervention. the study will be divided into three main phases: * ad libitum nicotine use (day 1): participants will smoke as usual. baseline assessments of emotion regulation (heart rate variability), neural activity (qeeg), stress responses (salivary cortisol), and nicotine craving will be conducted before and after exposure to a stress task. * acute 24-hour abstinence (day 2): participants will abstain from smoking for 24 hours. emotion regulation, neural activity, withdrawal symptoms, and cue-induced cravings will be assessed. * smoking cessation intervention (days 3 to 180): participants will engage in a computerized smoking cessation program. abstinence will be biochemically verified at 3 and 6 months post-quit. smoking lapses and time to relapse will also be monitored. the primary outcomes are maintenance of abstinence, smoking lapses, and time to relapse. secondary outcomes include changes in emotion regulation, neural activity, stress responses, withdrawal symptoms, and cue-induced cravings. the study hypothesizes that smokers who fail to maintain long-term abstinence will exhibit enhanced stress-induced high-frequency qeeg oscillations, disrupted connectivity in emotion regulation brain regions, and emotion regulation deficits. it is also hypothesized that the interplay between these measures will predict smoking cessation outcomes.

Eligibility criteria:
inclusion criteria: * age 18-60 years * smoking at least 10 cigarettes daily for at least 2 years * intention to quit smoking * medication-free exclusion criteria: * presence of psychiatric or medical treatment * pregnancy * current unstable medical illness * recent (prior 6 months) drug or alcohol use disorder * major depression * diagnosis of psychotic disorder

Keywords: nicotine relapse vulnerability biomarkers eeg hrv stress reactivity
effect of sms use on postoperative respiratory and cough exercise compliance

Conditions: Pulmonary Cancer; Surgery

Summary: aim: this randomized controlled trial study aimed to evaluate the effect of sms use on compliance with postoperative breathing and coughing exercises and patient satisfaction in patients undergoing pulmonary lobectomy for lung cancer surgery. material and methods: in the study, 62 patients who underwent lobectomy in a university hospital's thoracic surgery clinic between 01.02.2022 and 03.04.2023. the intervention group was chosen to be the group that received sms messages.

background: patients undergoing lung resection should be encouraged to cough, take deep breaths for pulmonary rehabilitation within the scope of enhanced recovery after surgery protocols. the success of protocols is related to patient compliance. sms-based interventions increase compliance with medications and protocols in surgical patients and reduce hospital readmission rates, while improving patients' clinical participation and satisfaction. aim: this randomized controlled trial study aimed to evaluate the effect of sms use on compliance with postoperative breathing and coughing exercises and patient satisfaction in patients undergoing pulmonary lobectomy for lung cancer surgery. material and methods: in the study, 62 patients who underwent lobectomy in a university hospital's thoracic surgery clinic between 01.02.2022 and 03.04.2023. the intervention group was chosen to be the group that received sms messages. "the information form", "postoperative exercise follow-up chart", "postoperative patient evaluation form" and "patient satisfaction form were used in data collection. independent sample t-test, pearson chi- square and mann whitney u test were conducted for statistical analyses.

Eligibility criteria:
inclusion criteria: * undergoing elective pulmonary lobectomy, * having preoperative normal lung capacity (pulmonary function test result fev1/fvc \>70%), * being compatible with the use of triflow, undergoing pulmonary lobectomy for the first time, * volunteering to participate in the study, * having mental competence, * not having turkish communication problems, * having a personal mobile phone and accepting to send sms, * being an adult (≥18) exclusion criteria: * if any smss are not received during the study period, the patient will be excluded from the study.

Keywords: short message service breathing and coughing exercises pulmonary lobectomy
impact of canadian haskap berry powder on hypertension and acuity in women's health

Conditions: Hypertension; Alertness

Summary: haskap berries are rich in cyanidin-3-o-glucoside (c3g), which has been shown in vitro to enhance endothelial function. previous clinical studies suggest haskap berry supplementation may improve cognition, mood, blood pressure, and athletic performance, but research is limited. this trial aims to contribute to the growing body of evidence on the effects of haskap berry supplementation. the trial is a 2-period, randomized, double-blinded, cross-over design lasting 16 weeks. during the first period (weeks 0-6), participants will receive either haskap berry powder or a control powder. a 4-week washout period follows (weeks 7-10), where no powder is consumed. in the second period (weeks 11-16), participants will receive the powder they did not consume in the first period.


Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent to participate in the trial; * biological female who is at least 35 years of age; * a waist circumference of at least 35 inches; * average systolic blood pressure between 120 and 150 mmhg; * average diastolic blood pressure between 75 and 100 mmhg exclusion criteria: * biological male; * gluten allergies, celiac disease, or gluten intolerance; * allergic to berries; * receiving chemotherapy; * use of medications containing pseudoephedrine or other anti-inflammatory drugs, and the use of cyclosporine or tacrolimusin; * cardiovascular diseases including stroke, congestive heart failure, myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, and transient ischemic attack within six months before screening; * inability to consume treatment product; * inability to provide written informed consent; * any of the following visual impairments: diabetic retinopathy, age-related macular degeneration, glaucoma, or cataract; * risk of epileptic seizures; * any form of motor impairments; * any visual impairments, uncorrected vision problems, eye disorders, or injuries * any medical condition, uncontrolled systemic disease, or concurrent illness that would hinder study compliance or jeopardize the participant's safety, based on the investigator's opinion
study to evaluate the activity and tolerability of lopinavir/ritonavir and lamivudine bitherapy in hiv patients with viral suppression

Conditions: HIV Infection

Summary: this is a prospective, open controlled trial in which hiv-1 with viral suppression patients will be randomized to continue with their current treatment (lopinavir/ritonavir plus emtricitabine or lamivudine plus any nucleoside analogue reverse transcriptase inhibitor) or to simplify to lopinavir/ritonavir plus lamivudine. randomization will be stratified according to the values of nadir cd4 and time of viral suppression.


Eligibility criteria:
inclusion criteria: * patients of either sex (female or male) and 18 years or older. * patients seropositive for hiv-1 using standard diagnostic criteria. * there is confirmation of viral load to be lower than 50 cop/ml during the 6 previous months to inclusion. the requirement is to have at least two viral loads lower than 50 cop/ml separated by 6 months and no one \>50cop/ml during the 6 months before inclusion. * patients on continuous haart consisting of lpv/r, emtricitabine (ftc) or 3tc (lamivudine) and an nrti for at least 2 months before being randomized in this study. * patients who are clinically stable, in the opinion of the investigator, at entry into the study (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization). patients receiving therapy for an active opportunistic infection are eligible for enrollment if the above criteria are met. standard prophylaxis of opportunistic infections is permitted. exclusion criteria: * pregnancy, nursing, or planned pregnancy during the study period. * previous failure with regimens including a protease inhibitor (pi) or 3tc/ftc. * known resistance mutations to pis or 3tc/ftc. * patients with an active opportunistic infection or malignancy. patients with a stable chronic opportunistic infection may be included in the study. * any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment. * patients diagnosed with visceral kaposi's sarcoma (ks), patients with lymphoedema secondary to cutaneous ks or cutaneous or palatine ks who have been treated with systemic immunosuppressive therapy must also be excluded. * patients with chronic hepatitis b on treatment with tenofovir + 3tc/ftc
influences of phenylephrine, dopamine and ephedrine on stroke volume variation and pulse pressure variation

Conditions: Circulation; Drug Dose; Calculated SAP

Summary: although induced hypertension decreased svv and ppv,the influences of stroke volume variation and pulse pressure variation caused by phenylephrine,dopamine and ephedrine were unknown.

pulse pressure variation (ppv) and stroke volume variation (svv) during mechanical ventilation have been shown to be effective parameters to predict preload responsiveness. although induced hypertension decreases ppv and svv, the influences of phenylephrine, dopamine and ephedrine on ppv and svv are unknown.

Eligibility criteria:
inclusion criteria: * their american society of anesthesiologists (asa) physical status was 1 or 2 * body mass index (bmi) ranged from 18 to 26 * none of the patients had known diabetes mellitus, hypertension, cardiovascular, pulmonary, endocrinological, neurological diseases, or diseases that influenced intravascular fluid volume or balance * all patients had a preoperative fast for at least 8 h and routine atropine intramuscular injection exclusion criteria: * persistent arrhythmias * intraoperative application of vasoactive drugs except phenylephrine, dopamine and ephedrine
dermacyd breeze (lactic acid) pocket br - compatibility

Conditions: Hygiene

Summary: to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product dermacyd breeze (lactic acid) pocket br.


Eligibility criteria:
inclusion criteria: * age between 18 and 60 years old; * phototype skin i,ii, iii e iv * integral skin test in the region; * willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; exclusion criteria: * lactation or gestation * use of antiinflammatory and/or immunosuppression drugs one month before the study; * personal history of atopy; * history of sensitivity or irritation for topic products; * active cutaneous disease; * use of new drugs or cosmetics during the study; the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
an extension study to evaluate the long-term safety and tolerability of ubrogepant in the treatment of migraine

Conditions: Migraine, With or Without Aura

Summary: this study will evaluate the long-term safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year.

usual care is the open-label control arm. dose of ubrogepant (50 mg or 100 mg) will be double-blind for active treatment arms.

Eligibility criteria:
inclusion criteria: -completed study ubr-md-01(nct02828020) or ubr-md-02(nct02867709). exclusion criteria: * patients with clinically significant electrocardiogram (ecg), vital sign, physical exam, or laboratory abnormalities * requirement for a medication during the study that is on the list of prohibited medications.
preemptive analgesia using intravenous paracetamol

Conditions: Adverse Anesthesia Outcome

Summary: dental treatment for children should be done in a calm atmosphere and without pain. oral propacetamol has been shown to be effective in a variety of postsurgical pain models. there are no studies on paracetamol preemptive analgesia effect on the pediatric population in the dental setting which compare analgesic effect when administered before vs after the dental treatment. the investigators hypothesis is that preoperative intravenous paracetamol are helpful in the prevention of postoperative pain in children undergoing dental treatment.

dental treatment for children should be done in a calm atmosphere and without pain in purpose to achieve a positive feelings and response towards dental treatment.postoperative pain is the main issue which may cause a negative attitude of the child to dental treatment in future appointment. one of the affective options to deal with this pain is to give analgesic drug before the initiative of treatment which should continue its effect during and may also after treatment which is known as "preemptive analgesia. oral propacetamol has been shown to be effective in a variety of postsurgical pain models. in double blind clinical trials single or multiple dose of intravenous paracetamol, generally provided significantly better analgesic effect than placebo treatment in adults' patients who had undergone dental, orthopedic or gynecological surgery. there is considerable evidence that the analgesic effect of paracetamol is central and is due to activation of descending serotonergic pathways, but its primary site of action may still be inhibition of prostaglandin synthesis by its selective inhibition of cox-2 isoenzyme. at the best of the investigators knowledge, there are no studies on paracetamol preemptive analgesia effect on the pediatric population in the dental setting which compare analgesic effect when administered before vs after the dental treatment. the investigators hypothesis is that preoperative intravenous paracetamol are helpful in the prevention or modification of postoperative pain in children undergoing dental treatment. the primary outcome of this study is to investigate the post dental treatment analgesic effect of intravenous paracetamol in children when administered before compared to after dental treatment.

Eligibility criteria:
inclusion criteria: * all children who require a wide treatment of caries * children of high score of anxious or who is stressfully exclusion criteria: * contraindication for paracetamol * renal or hepatic insufficiency * patient have history of allergy for paracetamol * anemia of hgb less than 10 gr/dl

Keywords: postoperative pain dental treatment paracetamol
relation of skin closure method to groin wound infections after proximal femoral artery exposure.

Conditions: Surgical Wound Infection

Summary: this study aims to asses whether the rate of surgical wound infections in vascular surgery procedures involving exposure of the proximal femoral artery can be reduced using a different skin closure technique.

summary of the research plan background - according to published articles the frequency of groin wound infections after peripheral revascularization varies substantially depending on the source from 5% up to 27%. aims of the study - the aim of this randomized clinical trial is to evaluate whether the number of groin wound infections can be reduced with an intradermal skin suture compared to the commonly used metal staples skin closure method. methods and study design - this is a randomized clinical trial of patients undergoing a vascular procedure which includes an incision in the groin. the patients will be randomized (1:1) to two different wound closure techniques: subcuticular suture or metal staples. after the procedure the patients will be controlled for four to six weeks and the infection rate in each group is recorded. a clinical diagnosis of infection according to centre for disease control (cdc) guidelines will be recorded, no microbiological samples will be routinely collected. statistical analysis - a power analysis has been conducted based on finnish rct studies and a retrospective study from our own hospital (submitted to annals of vascular surgery 1/2018) which included all isolated groin wounds from turku university hospital vascular surgery clinic 2015-2016. according to this analysis between 130-150 patients are needed for each group. time and schedule- this is a multicenter trial. ethical committee approval was acquired in 2015. the randomization will start in the spring of 2018 in the university hospital of turku. later in the year in the other hospitals that are participating in the study once the regional authorities have given their consent. ethical aspects - ethical committee approval was obtained in 2015. the wound closure techniques are all in everyday use already, nothing new and experimental will be used. budget - this study is a critical part of quality control and improvement in vascular surgery. the funding will be applied from the finnish academy and evo funding from the erva.

Eligibility criteria:
inclusion criteria: * primary procedure to the groin, isolated groin wound exclusion criteria: * emergency procedure, secondary procedure, wound is a part of a larger wound in the same limb

Keywords: woundclosure technique surgical site infection intrademal transdermal suture
transdiagnostic group therapy (gbat) for autistic adults with personalized therapeutics

Conditions: GBAT+Individual; GBAT+Engagement Booster; GBAT+Both

Summary: the purpose of this study is to build upon an earlier study that evaluated the use of a 10-week transdiagnostic group behavioral activation therapy (gbat), a telehealth delivered intervention, as a cost effective and accessible way to treat symptoms of anxiety and depression in autistic adults. the current study will pilot and compare relative feasibility, acceptability, and preliminary efficacy of three adapted gbat groups and a watchful waiting (ww) group. the three groups include gbat+individual (gbat+i; individual sessions to supplement the 10 group sessions), gbat+engagement booster (gbat+e; supplemental materials), and gbat+both (gbat+ie individual sessions and supplemental materials).


Eligibility criteria:
inclusion criteria: * live in new jersey or new york * be 18-40 years old * have a confirmed diagnosis of autism spectrum disorders (asd). * have access to a device (e.g., computer with a webcam or smartphone) in order to complete online surveys and participate in videoconference sessions * wrat reading comprehension grade equivalent 6th grade or higher * receive a best-estimate diagnosis of an anxiety or mood disorder (generalized anxiety disorder, social anxiety disorder, specific phobia, panic disorder, agoraphobia, major depressive disorder, unspecified depression, persistent depressive disorder). * be interested in participating in an online telehealth treatment group to address their difficulties in the aforementioned areas * approximately 60% of our sample will be white, non-hispanic; approximately 40% of our sample will be female-identifying and 40% will be male-identifying exclusion criteria: * are younger than 18 years old, or older than 40 years old * do not have an asd diagnosis * have wrat reading comprehension below 6th grade level * are unable to understand english fluently * have a principal dsm-5 disorder other than one of the above listed anxiety or depression disorders, have received a diagnosis of intellectual disability, schizophrenia, or bipolar disorder or demonstrate suicidal ideation or intent severe enough to require current hospitalization, or who have attempted suicide in the past 3 months. * are currently enrolled in another behavioral therapy or psychotherapy targeting depression, anxiety or anger. * are experiencing suicidal ideation that requires current hospitalization. * the pi's best clinical judgment that it would not be in the adult's best interest to be enrolled (e.g., due to factors that may affect their engagement or comfort in the group).