Kornimate/medical-research-clean huggingface dataset:
treatment of type 2 diabetes with linagliptin 2.5 mg bid + metformin 500 or 1000 mg bid and metformin 1000 mg bid

Conditions: Diabetes Mellitus, Type 2

Summary: a phase iii randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46


Eligibility criteria:
inclusion criteria: * signed and dated written informed consent, at the latest by the date of visit 1 * patients completing the entire treatment period of the double-blind study 1218.46, who are not treated with rescue medication (visit 7) exclusion criteria: * patients who meet one or more of the withdrawal criteria of the treatment period of the previous study 1218.46 * pre-menopausal women (last menstruation equal or less than 1 year prior to signing informed consent) who: * are nursing or pregnant, * or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. acceptable methods of birth control include transdermal patch, intra uterine devices/systems (iuds/iuss), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner and in addition for male partners a barrier method, such as the use of condom with spermicide. no exception will be made. * alcohol abuse within the 3 months prior to informed consent that would interfere with study participation * drug abuse that in the opinion of the investigator would interfere with trial participation * any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the study medication
fingolimod in endovascular treatment of ischemic stroke

Conditions: Stroke Inflammation

Summary: proof-of concept clinical trials have indicated that the sphingosine-1-phosphate receptor modulator fingolimod may be efficacious in attenuating brain inflammation and improving clinical outcomes in patients with acute ischemic stroke as a single therapy beyond 4.5 hours of disease onset, or in combination with alteplase within 4.5 hours of disease onset. this study aim to determine whether fingolimod enhance the action of endovascular treatment for acute ischemic stroke


Eligibility criteria:
inclusion criteria: * patients presenting with anterior circulation acute ischaemic stroke who are eligible for mechanical thrombectomy commenced within 6-24 hours of stroke onset. * patient, family member or legally responsible person depending on local ethics requirements has given informed consent. * patient's age is 18-80 years. * arterial occlusion on internal carotid artery proximal or middle cerebral artery * imaging inclusion criteria: infarct core volume between 15-70 ml exclusion criteria: * pre-existing neurologic disability (a score greater than 2 on the mrs). * swallowing difficulties that would prevent administration of oral fingolimod. * patients with any history of bradyarrhythmia, atrioventricular block or current use of beta-blockers or verapamil. * patients with serious acute or chronic infection, or hepatic injury * concomitant use of antineoplastic, immunosuppressive or immune modulating therapies. * macular edema.
nebulized dexmedetomidine combined with ketamine versus nebulized dexmedetomidine for cleft palate

Conditions: Sedation; Emergence Delirium

Summary: to compare the efficacy of the pre-operative nebulization of a combination of dexmedetomidine and ketamine versus nebulization of dexmedetomidine alone for sedation and prevention of emergence delirium in children undergoing cleft palate repair surgeries.

cleft palate is a common congenital anomaly. the american cleft palate-craniofacial association recommends that primary cleft palate repair should be ideally performed between 12-18 months after birth. the pre-operative period is quite distressing for children due to parental separation, application of face mask for induction of anaesthesia, fear of needles and unfamiliar faces. pre-operative anxiety is associated with adverse outcomes via elevation of stress markers, promoting fluctuations in hemodynamic, and negatively impacting postoperative recovery. there is a growing interest in the use of dexmedetomidine, a highly selective alpha-2 adrenergic agonist, for paediatric premedication. ketamine may attenuate dexmedetomidine-induced bradycardia and hypotension and accelerate the onset of sedation with no respiratory depression.

Eligibility criteria:
inclusion criteria: * patients with american society of anesthesiologists (asa) physical status i \& ii who will be scheduled for cleft palate repair surgeries exclusion criteria: * parent refusal * allergy to the study drugs * suspected difficult airway * patients with endocrine, renal, hepatic, and cardiac pathology * psychiatric diseases * asthmatic patients.

Keywords: dexmedetomidine ketamine nebulization cleft palate sedation emergence delirium
comparative effectiveness of iimr versus cdsmp

Conditions: Mental Illness; Chronic Disease

Summary: the study will enroll 600 people with serious mental illness who receive services at centerstone in ky or tn and will compare two different evidence-based self-management interventions: integrated illness management and recovery (i-imr), a program developed by the study team at dartmouth that trains people with serious mental illness on physical and mental health self-management, and the stanford chronic disease self-management program (cdsmp), a program largely focused on physical health self-management that has been used widely in the general population.

the proposed study will be the first to compare two commonly used but substantially different, evidence-based self-management interventions. integrated illness management and recovery (i-imr), is an individually-tailored, 16-session, integrated program combining both physical and mental health self-management specifically developed for people with smi. in contrast, the stanford chronic disease self-management program (cdsmp) is a group-based, 6-session, chronic disease self-management program largely focused on physical health self-management alone. i-imr is delivered by community mental health providers or by community outreach workers, while cdsmp is co-delivered by two peers or by a health professional and a peer. both programs have been widely recommended, disseminated, and used. the proposed parent study will randomize people with serious mental illness to i-imr (n=300) and cdsmp (n=300).

Eligibility criteria:
inclusion criteria: * serious mental illness (diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or chronic depression with moderate impairment in functioning) receiving services at centerstone(ky and tn) * diagnosis of a chronic medical condition increasing risk of early mortality from cardiovascular or respiratory disease (e.g., diabetes, hyperlipidemia, hypertension, copd, heart failure, tobacco dependence, obesity), and at least 1 er visit or hospitalization within the past year or judgment by the treatment team of substantial need for illness self-management training. exclusion criteria: * consumers who do not speak english * consumers with either no, or a well-controlled medical condition will not be included * individuals residing in a nursing home or other institution * evidence of significant cognitive impairment as indicated by a mini mental status examination score \<24, will be excluded eligibility for the covid -related substudy is dependent on enrollment and participation in the parent project.

Keywords: integrated health mental health illness management cardiovascular disease physical health
effect of acute exercise on endothelial function in patients with type 1 diabetes.

Conditions: Type 1 Diabetes Mellitus

Summary: the aim of this study is to evaluate the effect of a single session of aerobic plus resistance exercises on the vascular function of patients with type 1 diabetes mellitus. the investigators hypothesize that a single aerobic exercise session would promote greater benefit in vascular function of patients with type 1 diabetes, as compared with the resistive exercise session.

the aim of this study is to compare the effect of endurance and resistance exercises on endothelial function in patients with type 1 diabetes mellitus (t1dm). for this purpose, the sample size will consist of 15 patients with dm1, aged between 18 and 45 years, which will undertake the two types of exercises, randomly distributed. ergospirometry testing will be performed in order to assess possible contraindications to the proposed protocol as well as functional capacity, which will be used in prescription of the endurance exercise session. similarly, a strength maximal testing will be conducted and used in the prescription of the resistance exercise session. the endothelial function will be evaluated by vascular reactivity of the forearm and circulating endothelial progenitor cells (epc) counting. to analyze the vascular reactivity of the forearm, non-invasive venous occlusion plethysmography will be used, whereas flow cytometry method will be used to the analysis of the number of circulating epc. the endurance exercise session will consist of 40 minutes of cycling on heart rate corresponding to 60% of vo2 max. the resistance exercise session will last 40 minutes, consisting of 4 sets of 12 repetitions at 60% of 1rm, in four exercises for lower limbs. the research will be performed at the exercise pathophysiology research laboratory of the hospital de clinicas de porto alegre. the investigators expect to find greater increase in the number of circulating epc after the endurance exercise session, when compared to the benefits obtained from a session of resistance exercise. likewise, it is expected to find greater benefits in relation to vascular reactivity of the forearm after a session of endurance exercise when compared to a session of resistance exercise. considering that most part of the studies that analyze the effects of physical exercise on vascular function does not involve patients with dm1, this project aims to provide a clearer picture of the benefits of different exercises in the acute response of endothelial function in these patients.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * male gender * 18-45 years old exclusion criteria: * severe autonomic neuropathy * diabetic nephropathy established * chronic kidney failure * limb amputation * disabling peripheral arterial disease * coronary artery disease * heart failure * diabetic proliferative retinopathy * neoplasms * smokers * regular physical training

Keywords: type 1 diabetes mellitus endothelial progenitor cell endothelial function exercise
cosmesis and body image after single port or 4-port laparoscopic cholecystectomy

Conditions: Symptomatic Gallstone Disease

Summary: laparoscopic cholecystectomy (lc) is the treatment of choice for symptomatic gallstone disease. single-port access cholecystectomy (sl) has been recently introduced using only one, trans-umbilical placed port. the method has been denominated as ''scarless.'' however, it is unknown whether sl significantly improves body and cosmesis images as well as the quality of life (qol), reported directly by the patients. furthermore sl promises to reduce postoperative pain and to be cost-effective due a faster postoperative recovery. the aim of this double blind randomized controlled trial (rct) is to demonstrate whether sl is superior to lc in improving patients', body and cosmesis images as well as qol and to analyse cost-efficiency. based on the sample size calculations, a total of 110 patients will be randomised to either lc or sl. the primary endpoint will be the cosmetic score. costs, pain, time to convalescence, quality of life and complications and will also be compared as secondary endpoints. this study will provide evidence-based patient-oriented information regarding the sl procedure and its further use.


Eligibility criteria:
inclusion criteria: 1. patients above 18 years of age for elective cholecystectomy 2. written informed consent from the subject 3. inr \ 50'000/mcl exclusion criteria: 1. women in pregnancy 2. contraindications on ethical grounds 3. severe coagulopathy (platelet \ 1.4 4. liver cirrhosis 5. enrolment of the investigator, his/her family members, employees and other dependent persons

Keywords: cholecystectomy laparoscopic single-port gallstones
the clareon panoptix trifocal iol: visual outcomes and patient satisfaction

Conditions: Cataract

Summary: this will be a single arm, open-label, prospective study of patient-reported outcomes of patients with bilateral implantation of the panoptix or panoptix toric implant.

the panoptix trifocal lens by alcon was introduced in 2015 and is currently in use in over 70 countries. its outcomes on the acrysof platform are well documented and highly appealing to patients and clinicians.,, clinicians no longer need to routinely target monovision or modified monovision to provide a range of vision. with the release of the clareon material for this lens, questions remain about how the new lens material will influence patient satisfaction and uncorrected visual performance.

Eligibility criteria:
inclusion criteria: * patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures. * patients implanted with clareon panoptix or clareon panoptix toric lenses bilaterally within 6 months of the survey administration. exclusion criteria: * patients with visually significant comorbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery * patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered iol, cystoid macular edema, etc.) * patients with previous refractive surgery within the past 6 months prior to cataract surgery * patients with \> grade 1 posterior capsule opacity at their last visit
effects of antidepressants on sexual functioning in adults

Conditions: Major Depressive Disorder (MDD)

Summary: this study will evaluate the effects of two antidepression medications on sexual functioning.


Eligibility criteria:
inclusion criteria: * primary diagnosis of major depressive disorder (mdd) with current duration lasting 12 weeks but no greater than 2 years. * subjects must engage in sexual activity that leads to orgasm at least once every two weeks. * subject must have normal orgasmic function and be willing to discuss with investigator. exclusion criteria: * subjects that have arousal or orgasm dysfunction. * has previously failed to respond to two adequate trials of antidepressants in past 2 years. * subject has other unstable medical disorders. * subject has a positive urine test for illicit drug use at screening.

Keywords: depression, sexual dysfunction, orgasm disorder, mdd
hpi in laparoscopic colorectal surgery

Conditions: the Duration and Severity of Intraoperative Hypotension

Summary: using the hypotension prediction index in patients undergoing laparoscopic colorectal surgery, including data from national taiwan university hospital and taipei veterans general hospital

intraoperative hypotension is a common occurrence during laparoscopic colorectal cancer resection, often attributable to factors such as general anesthesia, the growing population of elderly patients, and the use of pneumoperitoneum during surgery. this condition, defined as a mean arterial pressure (map) below 65 mmhg, is linked to major organ complications within 30 days postoperatively. introduced in 2019, the hypotension prediction index (hpi) is an algorithm designed to predict the onset of intraoperative hypotension. previous studies have used the time-weighted average map below 65 mmhg as a primary endpoint, calculated as the area under the map curve \<65 mmhg (mmhg × hours) divided by the duration of surgery (hours), with a value ≥0 indicating severity. higher values reflect more severe hypotension. however, research on the application of hpi in laparoscopic colorectal cancer resection remains limited. this study aims to determine whether the use of hpi can reduce the severity of intraoperative hypotension in patients undergoing laparoscopic colorectal cancer resection and whether it can decrease the incidence of major postoperative organ complications. a total of 120 patients, aged 20-80 years and undergoing elective laparoscopic colorectal cancer resection, will be randomly assigned to two groups: an intervention group guided by hpi and a control group without hpi guidance. in the intervention group, an alert will be triggered when the hpi exceeds 85, indicating a potential map drop below 65 mmhg, whereas the control group will initiate hypotension treatment only when map falls below 65 mmhg. both groups will adhere to the same intraoperative hypotension management protocols, including fluid resuscitation, vasopressor administration, and observation. the primary treatment outcome will be the time-weighted average map \<65 mmhg, and major postoperative organ complications will be monitored for 30 days post-surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing elective laparoscopic colorectal surgery exclusion criteria: * severe heart or lung diseases

Keywords: hypotension prediction index intraoperative hypotension laparoscopic colorectal surgery
efficacy of probiotic capsules with topical clobetasol propionate in olp treatment

Conditions: Oral Lichen Planus

Summary: oral lichen planus patients who will meet inclusion criteria will be divided into 2 groups -the intervention group (group p): this group will be randomly allocated to take one capsule twice daily during meal time at morning and evening of probiotics complex obtained from biovea for 4 -week study period. moreover, patients in this group will be instructed to apply clobetasole propionate in orabase gel 2 times daily for 4 weeks. patients will receive their supply of the gel and probiotics every 2 weeks. the control group (group b): this group will be randomly allocated to apply clobetasol propionate in orabase gel 4 times daily after meal times and before sleeping for 4 weeks. at the 3rd week this group will be instructed to apply miconazole gel 4 times daily as a prophylaxis for two weeks. salivary sample collection: unstimulated salivary sample was collected from all participants twice , once at baseline and another time after 4 weeks from the study period. saliva was collected in graduated clear test tubes to be used in the evaluation of candidal counts before and after treatment . patient's visits was at baseline, 2 weeks and 4 weeks.


Eligibility criteria:
inclusion criteria: * patients who are diagnosed with symptomatic lichen planus whether bullous erosive or erythematous oral lichen planus. * male or female patient with age range between 20-75 years old were included. * medically free individuals exclusion criteria: * the use of systemic antibiotics, corticosteroids or immunosuppressive agents within four weeks prior to enrollment in the study. * pregnant females * patients with history of systemic disorder affecting the immune system * active liver diseases and cancer * allergy or intolerance to probiotics. * any other oral lesions

Keywords: oral lichen planus probiotics clobetasol probionate
a 6-month, randomized, open-label, patient outcomes, safety and tolerability study of fingolimod (fty720) 0.5 mg/day vs. comparator in patients with relapsing forms of multiple sclerosis

Conditions: Relapsing Forms of Multiple Sclerosis

Summary: the purpose of this study is to evaluate the change in patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patients with relapsing forms of multiple sclerosis on previous disease modifying therapy (dmt) who are randomized to one of two treatment arms: fingolimod vs. standard of care dmt.


Eligibility criteria:
inclusion criteria: * relapsing forms of ms * expanded disability status scale (edss) 0-5.5 * continuous treatment with ms dmt for a minimum of 6 months * fingolimod naive exclusion criteria: * immune system diseases other than ms * active macular edema * history of selected prior infections and criteria for immunizations * history of selected immune system treatments and/or medications * selected cardiovascular, pulmonary, or hepatic conditions * selected abnormal laboratory values * pregnant or nursing women other protocol-defined inclusion/exclusion criteria applied

Keywords: relapsing forms of multiple sclerosis disease modifying therapy fingolimod patient reported outcomes
safety and efficacy of tpbm for epileptiform activity in autism

Conditions: Autism Spectrum Disorder; EEG With Periodic Abnormalities; Epilepsy; Neurodevelopmental Disorders; Neurological Disorder

Summary: for this study, the proposed intervention will be noninvasively delivered near infra-red (nir) light - transcranial photobiomodulation (tpbm) - to the brains of autistic children. this will occur, twice a week, for 10 weeks. the nir light is delivered to specific brain areas by cognilum, a wearable device developed by jelikalite. the expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. cognilum may impact the clinical practice of treating autism. at the beginning, at five weeks, and at the end of study, the clinician will complete the cars-2, srs, cgi, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions.


Eligibility criteria:
inclusion criteria: * autism spectrum disorder (diagnosed as autistic disorder on the ados-2 or the adi-r). * between 4 and 12 years of age, at baseline. * autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale. moderate level of autism severity (4) is defined by the diagnosis of asd with language impairment. * ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period. * unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry * ability to tolerate procedures, as determined at the discretion of the investigator. * at least one 24hr eeg with data in edf format that is accessible to investigators. exclusion criteria: * significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior * severely affected children as defined by cgi-severity standard score = 7 (extremely ill) * severe prematurity (\<34 weeks gestation) as determined by medical history * current uncontrolled gastroesophageal reflux disease since gerd can cause movements that appear like seizures * genetic syndromes * congenital brain malformations * any medical condition that the pi determines could jeopardize the safety of the study subject or compromise the integrity of the data. * failure to thrive or body mass index \&lt; 5%ile or \&lt;5%ile for weight (male \&lt;11.2kg; female \&lt;10.8kg by cdc 2000 growth charts) at the time of the study. * concurrent treatment with drug that would significantly interact with treatment. * • stimulants * • anti-psychotics * • antihistamines * excessive hair that the caregivers are unwilling or unable to shave or braid. * inability to tolerate the required dosage of tpbm treatment due to sensory issues.

Keywords: autism epilepsy neurological disorders neurodevelopmental disorders asd