Kornimate/medical-research-clean huggingface dataset:
brexpiprazole as adjunctive treatment in patients with major depressive disorder with an inadequate response to antidepressant treatment

Conditions: Major Depressive Disorder

Summary: to evaluate the long-term efficacy and safety of brexpiprazole as an adjunctive treatment to an antidepressant treatment (adt) for adult patients with major depressive disorder (mdd).

the total duration of the study was 32 weeks and the study consisted of periods a, b, and a+. patients entered the study in period a and were treated open-label with one of six commercially available antidepressant treatments (adts) for 8 weeks. patients who met the blinded response criteria at the week 6 visit, were deemed early responders and were withdrawn from the study. at week 8, patients with inadequate response to placebo + adt, as per the randomisation criteria, entered period b and were randomised to received double-blind brexpiprazole + adt or placebo + adt for 24 weeks. non-randomised patients continued in period a+ and received placebo + adt until the end of the study. the primary objective was to compare the efficacy and safety of brexpiprazole with placebo. this comparison occurred period b; therefore, the focus is period b.

Eligibility criteria:
inclusion criteria: * the patient is an outpatient consulting a psychiatrist. * the patient has an mdd diagnosed according to dsm-iv-tr™. the current major depressive episode (mde) should be confirmed using the mini international neuropsychiatric interview (mini). * the patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressant treatments. * the patient agrees to protocol-defined use of effective contraception. exclusion criteria: * the patient has any current psychiatric disorder or axis i disorder (dsm-iv-tr™ criteria), established as the primary diagnosis, other than mdd. * the patient has a current axis ii (dsm-iv-tr™) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypical or histrionic personality disorder. * the patient has experienced/experiences hallucinations, delusions or any psychotic symptomatology in the current mde. * the patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (dsm-iv-tr™ criteria). * the patient, in the opinion of the investigator or according to columbia-suicide severity rating scale (c-ssrs), is at significant risk of suicide. * the patient has had neuroleptic malignant syndrome. * the patient has any relevant medical history or current presence of systemic disease. * the patient has, at the screening visit an abnormal ecg that is, in the investigator's opinion, clinically significant. * the patient has a history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin, that has not been in remission for \>5 years prior to the first dose of imp. * the patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason. other inclusion and exclusion criteria may apply.
a novel echocardiography modality to assess left ventricular dyssynchrony

Conditions: Heart Failure

Summary: the investigators hypothesize that the relation between mechanical and hemodynamic left ventricular dyssynchrony might better predict response to cardiac resynchronization device(crt) than currently existing echo indices.

cardiac resynchronization therapy is emerging to be a highly effective treatment option for selected patients with symptomatic congestive heart failure on optimal medical therapy and evidence of left ventricular (lv) conduction delay and contraction dyssynchrony. it can improve quality of life and results in better survival in this selected group of patients. however, patients have different responses to crt, and up to 30% of those implanted show no response at all. ongoing trials, whether prospective or retrospective, have been trying to define best predictors of response to crt and to measure ventricular dyssynchrony. despite this, no single echo criterion to date can predict successful crt over current guidelines. in this study, we propose to compare lv muscle mechanical dyssynchrony assessment by speckle tracking to hemodynamic dyssynchrony assessment by 4d segmental ejection fraction (ef), a novel modality brought recently by university of missouri echocardiography laboratory.

Eligibility criteria:
inclusion criteria: * cardiac resynchronization therapy(crt) device implanted in the last 5 years. exclusion criteria: * acute decompensated congestive heart failure. * chronic permanent atrial fibrillation
comparison of photorefraction with cycloautorefraction and cycloretinoscopy at emam hosein medical centre in 2008-2009

Conditions: Amblyopia

Summary: screening of refractory defect is one of major reason for amblyopy. photorefraction is a new method with some advantages in treatment of this problem. in this study the investigators are going to compare the results of this surgery in children between 1 to 10 years old with cycloautorefraction in children above 3 years old.


Eligibility criteria:
inclusion criteria: * amblyopy * children between 1 to 10 years old

Keywords: children between 1 to 10 years old amblyopy
to study the efficacy and safety of tips (trans intrahepatic portosystemic shunt) versus self expanding metallic stent (sems) in the management of refractory variceal bleed in cirrhotics.

Conditions: Liver Cirrhoses

Summary: a total of 50 patients will be enrolled and will be randomized into either group a(tips) or group b (sems). primary end point of the study will be to compare efficacy of tips versus sems for survival at 6 week or early re bleed. all enrolled patients will also undergo hvpg measurement at baseline to stratify risk of failure to control bleed or early re-bleed. patient will be monitored for 5 days for re bleed, complications of therapy, worsening of liver function tests and scores and efficacy of either treatment modality over other. patient will be followed for 6 weeks to see for the primary end point.


Eligibility criteria:
inclusion criteria: - consecutive patients of cirrhosis aged 18-70 years presenting with acute variceal bleeding, who on endoscopy fail to control bleed or rebleeds within 5 days will be randomized. exclusion criteria: * bleeding from non-variceal source * coagulopathy related bleed * bleeding from gastric varices * any malignancy including hcc * main portal vein thrombosis * patients in refractory shock * patients with severe cardiopulmonary disease * grade 4 hepatic encephalopathy * meld \> 25 * multiorgan failure * active sepsis * pregnancy * failure to give consent
postoperative cognitive dysfunction in patients undergoing pituitary removal surgery

Conditions: Pituitary Tumor

Summary: as postoperative cognitive dysfunction rates are high especially in elder patients, cognitive dysfunction is not diagnosed and treated effectively. this statement is associated with prolonged hospital stays by increasing morbidity. we wanted to see the incidency of postoperative cognitive dysfunction in patients undergoing elective pituitary tumor removal surgery.


Eligibility criteria:
inclusion criteria: * asa i-ii patients * undergoing elective pituitery tumor removal surgery exclusion criteria: * \>ii asa scores * using antidepressant agents * patient refusal * mental diseases
"menphys: intervention protocol for physical wellness in mental health"

Conditions: Severe Mental Disorder

Summary: the primary aim of this project is to establish the acceptability of the pai (physical activity intervention) to service users by evaluating if participants can be recruited into the study and if they complete the intervention. secondary aims are to estimate if, compared with treatment as usual (tau), the pai intervention (1) positively impacts on subjects' psychiatric symptoms (2) succeeds in improving cardiovascular fitness performance. in addition, will be considered the impact of the pai versus tau on sleep behavior, quality of life, drug consumption, reduces sedentary behaviour and unscheduled readmissions to the department within 30 days and within 7 days after their dismission.


Eligibility criteria:
inclusion criteria: * diagnosis of any smi * meeting any one of the following criteria as determined by a care co-ordinator: 1. overweight 2. at risk for or have type 2 diabetes mellitus 3. in the clinician's view, have a sedentary lifestyle 4. smoke tobacco * ability to provide informed consent * ability to understand italian exclusion criteria: * under the age of 18 * not having a diagnosis of smi * be unable to do exercises * be unable to give informed consent
imaging of dissection of the descending aorta

Conditions: Dissection of the Descending Aorta

Summary: patients with dissection of the descending aorta will be followed up according to a precise timeline.

nmr baseline a pet scanner will be performed minimum 3 months post dissection 6 months and every year during three years after pet scanner : ct scanner and blood sample

Eligibility criteria:
inclusion criteria: * 18 years * seen for dissection of the descending aorta * dissection of the descending aorta within the last three months * affiliation to social security * signed informed consent exclusion criteria: * intervention programmed in relation with dissection of the descending aorta * pregnant female * adults without legal capacity
investigating the use of a preoperative high-arginine nutritional supplement prior to radical cystectomy

Conditions: Bladder Cancer

Summary: to provide patients with bladder cancer who are scheduled to undergo radical cystectomy with a preoperative high-arginine nutritional supplement. the investigator will measure patient adherence to the regimen, tolerability of the supplement and feasibility of supplementation. secondary outcome measures will include differences in length of stay and complication rate between groups.

the purpose of this study is to investigate the use of a high-arginine protein supplement prior to surgery for patients undergoing radical cystectomy for treatment of bladder cancer. as many as 50% of patients who undergo radical cystectomy experience a postoperative complication, and poor preoperative nutritional status is known to increase the risk of complications. preoperative use of a high-arginine protein shake has been shown to reduce the risk of postoperative complications for patients undergoing surgery for colon cancer, and this study seeks to determine whether this is also true for patients undergoing radical cystectomy for bladder cancer. subjects will drink four protein shakes (nestle impact ar) per day for 5-7 days prior to radical cystectomy. shakes will be provided to patients free of charge. on the date of surgery, subjects will turn in a log of shake consumption. surgery will then proceed in typical fashion, and no changes will be made to surgery or postoperative care. clinical outcomes for the first 90 postoperative days will be collected. patient outcomes will be compared to those of contemporary controls who do not undergo supervised nutritional supplementation. primary study outcome is to assess safety, tolerability and adherence to supplementation regimen. secondary outcomes include differences in complication rates and length of postoperative hospital stay between groups.

Eligibility criteria:
inclusion criteria: * any adult patient seen at one of the aforementioned upmc facilities who carries a diagnosis of bladder cancer and is considered a candidate for radical cystectomy for treatment. exclusion criteria: * minors \< 18 years of age, patients not considered surgical candidates, patients who do not go on to undergo radical cystectomy. patients with glomerular filtration rate (gfr) \< 30 will also be excluded in an attempt to limit protein intake of patients with stage iv and v chronic kidney disease. diabetic patients will be allowed to participate.

Keywords: urinary diversion bladder neoplasm nutritional supplement cystectomy
responsiveness index versus the rass based method for adjusting sedation in critically ill patients

Conditions: Critical Illness

Summary: systematic evaluation of pain, agitation and delirium in icu-patients is recommended and deep sedation should be avoided. sedation is still monitored with clinical assessments, like rass. the responsiveness index (ri) is a recently described method for icu sedation monitoring. it is based on processed frontal emg and reflects the interaction between a patient's conscious state and the intensity and frequency of stimulations during treatment. ri has not been randomly compared to rass to titrate sedation to target at a clinically adequate sedation state. in this open randomized controlled pilot study of 32 critically ill, mechanically ventilated adult patients, investigators will evaluate the feasibility, safety and efficacy of ri based sedation compared to standard rass based titration of sedation. investigators hypothesize first that ri controlled sedation will be safe and, second that ri controlled sedation will associate with increased number of ventilator free days alive in 30 days without excess adverse events.

sedation of intensive care patients is needed for patient's safety but deep sedation is associated with adverse outcomes. frontal electromyogram based responsiveness index (ri) aims to quantify patient's arousal. ri monitoring together with staff education may have potential to improve sedation quality. investigators will evaluate the safety of ri based sedation versus standard care using richmond agitation-sedation scale (rass) for sedation. methods: randomized study, critically ill adult patients with mechanical ventilation and administration of sedation to either ri- or rass-guided sedation. propofol (and midazolam combined with if needed) as a hypnotic drug and oxycodone as an analgesic drug. investigators will follow standardized sedation protocol in both groups to achieve the predetermined target sedation level: either ri 40-80 (ri-group) or rass -3-0 (rass group). ri measurement is continuous in both groups, but blinded in the rass group. accordingly, ri group is blinded to rass assessments. state entropy (se) will register in both groups.

Eligibility criteria:
inclusion criteria: * intensive care patients * need of mechanical ventilation and sedation exclusion criteria: * contraindication to propofol or oxycodone * hypoxic or traumatic brain injury * intracranial hemorrhage * status epilepticus * drug overdose as admission diagnosis

Keywords: sedation, responsiveness index, electromyogram
development of a targeted patient portal intervention to improve depression treatment adherence and outcomes

Conditions: Depression

Summary: the purpose of this research study is to learn how best to use patient portals to help improve the treatment of mood disorders.

this study is being done in 3 phases. first 2 phases were observational with total enrollment of 300 subjects. the final 3rd phase is interventional and we are anticipating to enroll 50 subjects. it is described below. patients being treated for depressive symptoms at the university of iowa, department of psychiatry are invited to participate. participants will complete a remote (phone or video) visit. after being informed about the study and potential risks, those who consent to being in the study will be assigned to one of two groups. they will complete an online survey and receive some basic training on patient portals. after the visit. both groups will be followed for 6 months. depending on their group assignment, they will complete: * two to five phone calls with a study team member and * two to five online questionnaires

Eligibility criteria:
inclusion criteria: * english speaking, * phq-9 score of 10 or higher (questions 1-8 only), * taking medication for depressive symptoms, * 1 or more appointments scheduled or planned with university of iowa psychiatry provider in next 6 months, * home computer w/internet access, * mychart (university of iowa healthcare's patient portal) account/mychart enrollment exclusion criteria: * psychotic disorder/symptoms, * current substance use disorders (other than alcohol, tobacco, marijuana), * active suicidal ideation within past 1 year, * cognitive impairment

Keywords: patient portals treatment adherence
imatinib + mtc in relapsed / refractory acute myeloid leukemia (aml)

Conditions: AML

Summary: the purpose of this study is to show superiority in complete responses of combination therapy mtc plus glivec in patients with refractory or relapsed aml compared to a historical control which was treated with mtc alone.


Eligibility criteria:
inclusion criteria: * refractory aml after primary therapy * first relapse after a safe previous diagnosis of de novo or secondary aml * age \> 18 years * serum bilirubin \< 2.0 mg/dl * serum creatinine \ 60 ml/min * ecg and heart echography prior to start of therapy without severe findings * overall condition \< 2 according to ecog criteria * life expectancy \> 6 weeks * written informed consent by patients with full legal capacity exclusion criteria: * serious secondary disease (clinically relevant cardiac disease, chronic- obstructive pulmonary disease, hepatic dysfunction, renal insufficiency) * active secondary neoplasia (exception: adequately treated basalioma or epidermoid cancer and cervical carcinoma) * known hypersensitivity to topoisomerase-i inhibitors * overall condition \> 2 according to ecog criteria * pregnant/breast feeding women * serious intercurrent infections
effect of telerehabilitation for young adults

Conditions: Young Adult Health

Summary: it aims to examine the effects of video-based cervical posture and breathing exercises on the musculoskeletal system, pain and emotional stress levels in young adults. control group (n: 15), study group (n: 15); it aims to examine the effects of video-based application support and breathing exercises and cervical posture exercises on the musculoskeletal health, which is important for individuals, pain affecting daily life and emotional stress levels, which we think have a great effect on social life, and to present them to the literature. primary objective: to examine the effects of video-based cervical posture and breathing exercises on musculoskeletal health in young adults. secondary objective: to examine the effects of video-based cervical posture and breathing exercises on pain in young adults. tertiary objective: to examine the effects of video-based cervical posture and breathing exercises on emotional stress levels in young adults.

the study will include 30 randomly selected individuals between the ages of 18 and 30 who were directed to the istanbul gedik university physiotherapy and rehabilitation department laboratory. the individuals included in the study will be divided into 2 groups as a control group and a study group of 15 people with simple randomization. only a brochure will be given to the control group, and the brochure will be distributed and explained to the study group, and telerehabilitation will be applied. the study will be carried out in the istanbul gedik university physiotherapy and rehabilitation department laboratory.

Eligibility criteria:
inclusion criteria: * 18 - 30 years old * having enough technological equipment * female - male gender * volunteering to work exclusion criteria: * those with vertigo * those with frequent nausea * those with severe dyspnea * those with rib fractures

Keywords: cervical posture exercises video-based exercise breathing exercises
characteristics of tracetogether users

Conditions: Coronavirus

Summary: in this protocol, we seek the understand the demographics of individuals who have used the tracetogether mobile application. little is known about the group of individuals who are more likely to utilise the application. hence, this study hopes to: (1) understand the demographics of singaporeans who use and do not use tracetogether, (2) identify other behavioural habits of people who do use tracetogether, (3) determine if confidence in government would have any effect on tracetogether usage


Eligibility criteria:
inclusion criteria: * at least 21 years * has stayed in singapore for at least 2 years exclusion criteria: * below 21 years * has stayed in singapore for less than 2 years

Keywords: contact tracing tracetogether covid-19
study of the indications for amyloid positon emission tomography (pet) scans and their usefulness for patients with suspected alzheimer's disease (ad)

Conditions: Alzheimer Disease

Summary: the recent clinical authorization of amyloid positon emission tomography (pet) in france represents a crucial step for the nuclear medicine community involved in the diagnosis of alzheimer's disease (ad).

the recent clinical authorization of amyloid positon emission tomography (pet) in france represents a crucial step for the nuclear medicine community involved in the diagnosis of alzheimer's disease (ad). at the era of amyloid, tau, neurodegeneration (atn) biomarkers, amyloid pet fills a need in patients with an atypical or mixed clinical presentation, in particular young patients (\< 65 years old), when the lumbar puncture is contraindicated or not feasible for technical reasons. importantly, a negative amyloid pet scan discards the diagnosis of ad. furthermore, early phase imaging of amyloid pet allows to estimate the perfusion neuronal state, increasing the diagnostic value of such pet radiotracer. its role could be further developed in routine care for the selection and monitoring of promising disease modifiers therapies.

Eligibility criteria:
inclusion criteria: * patients aged = or \> 18 years * patients who have had an amyloid pet scan with a pet request form including the indications for the examination * patient informed via a newsletter and non-opposition to the use of their data for research purposes (research objectives clearly explained in the letters) exclusion criteria: * patient opposition to the use of their data for this research
effects of vitamin d and omega-3 fatty acids on infectious diseases and hcap18 (vital infection)

Conditions: Infections; Human Cathelicidin Antimicrobial Peptide (hCAP-18)

Summary: the vitamin d and omega-3 trial (vital; nct 01169259) is an ongoing randomized clinical trial in 25,875 u.s. men and women investigating whether taking daily dietary supplements of vitamin d3 (2000 iu) or omega-3 fatty acids (omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. this ancillary study is being conducted among participants in vital and will examine whether vitamin d or omega-3 fatty acids affect risk of infection and plasma hcap18 levels.


Eligibility criteria:
participants in vital (nct 01169259) are eligible to participate in this ancillary study. please see nct 01169259 for lists of inclusion and exclusion criteria.