Kornimate/medical-research-clean huggingface dataset:
study of brexpiprazole as adjunctive treatment of sleep disturbances in patients with major depressive disorder

Conditions: Sleep Disturbances

Summary: to assess effects of brexpiprazole on sleep patterns of depressed patients with sleep disturbances.


Eligibility criteria:
inclusion criteria - at screening: * the patient has a major depressive episode (mde) associated to major depressive disorder (mdd), diagnosed according to diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr™). the current mde should be confirmed using the mini international neuropsychiatric interview (mini). * the patient has an inadequate response to at least one antidepressant treatment (including the treatment the patient is taking at screening) in the current mde, as documented by self-report as less than a pre-defined response on the massachusetts general hospital antidepressant treatment response questionnaire (atrq). * the patient has a pre-defined montgomery aasberg depression rating scale (madrs) total score, and a pre-defined clinical global impression - severity of illness (cgi-s) score at screening, and has had the current mde for ≥10 weeks. * the patient is currently treated for the current mde with an adequate selective serotonin reuptake inhibitor (ssri) or a serotonin-norepinephrine reuptake inhibitor (snri) antidepressant treatment for ≥6 weeks, at the same dosage for ≥2 weeks. * the patient has sleep disturbances (difficulty falling asleep and/or difficulty staying asleep and/or problem waking up too early) confirmed by a pre-defined insomnia severity index (isi) score. * the patient agrees to protocol-defined use of effective contraception. entry criteria to treatment period (baseline visit): * the patient still fulfils dsm-iv-tr™ criteria for mde. * the patient received the same ssri or snri antidepressant treatment at adequate dose during the entire lead-in period. * the patient has a pre-defined madrs total score. * the patient's improvement in the madrs total score is a pre-defined percentage compared to screening. * the patient has a pre-defined clinical global impression - global improvement (cgi-i) score. * the patient has sleep disturbances (difficulty falling asleep and/or difficulty staying asleep and/or problem waking up too early) confirmed by a pre-defined isi score. * the patient has sleep disturbances confirmed by pre-defined latency to persistent sleep (lps) and pre-defined sleep efficiency (se). exclusion criteria: - 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.
effectiveness of soft robotic glove versus ems on hand function and quality of life in stroke survivors (rct)

Conditions: Stroke

Summary: this study will evaluate the effectiveness of soft robotic gloves versus electrical muscle stimulation (ems) in improving hand function and quality of life in stroke survivors. stroke often leads to impaired hand mobility, impacting daily activities and reducing overall quality of life. soft robotic gloves, designed to assist with hand movement, will provide mechanical support and encourage voluntary muscle activity. ems, on the other hand, will stimulate muscle contraction through electrical impulses, potentially enhancing muscle strength and coordination.

participants will be divided into two groups: one will receive treatment using soft robotic gloves, and the other with ems. outcomes will be assessed using standardized hand function tests and quality-of-life questionnaires over a specified period. results are expected to indicate that both interventions will improve hand function and quality of life, with the robotic gloves showing a marginally greater improvement in dexterity and grip strength, while ems will yield benefits in muscle reactivation and endurance. stroke survivors in the robotic glove group are anticipated to report greater ease in performing daily tasks, while the ems group will note an increase in muscle engagement.

Eligibility criteria:
inclusion criteria: * had ischemic or hemorrhagic stroke ≤6 months. * mini-mental status exam scores \> 24(7). * gcs score 11 to 15(2) * fma-ue score \< 21(3) exclusion criteria: * participants with severe vision or hearing impairment. * neurological disorders including epilepsy, alzheimer's disease, vertigo, parkinson disease, and , muscular disorders which limit functional activity (oa, ra, etc). * peripheral vestibular disorder. * medications that affect balance, severe cardiovascular conditions, recent lower limb injury or surgery. * contraindications for ems: patients with certain medical conditions, such as pacemakers, implantable cardioverter-defibrillators, or metal fragments in their body, that contraindicated the use of ems were excluded.
task-sharing and shifting model for acute low back pain

Conditions: Low Back Pain

Summary: background: the aging population and the rising prevalence of musculoskeletal disorders increase resort to primary care services. models of care integrating task sharing and shifting (ts/s) can help face challenge of access to care by strengthening the role of healthcare professionals. in france, a new ts/s model is being implemented between family physicians (fps) and physiotherapists (pts) for acute low back pain (lbp) patients' care. the aim of this study is to evaluate the effect of this new model of care on patient clinical outcomes, healthcare resources use and patient satisfaction. design: pragmatic cluster randomized controlled trial


Eligibility criteria:
inclusion criteria: * patients from 20 to 55 years old * suffering from acute low back pain since less than 4 weeks * able to understand and speak french * whose family physician is included in the task-sharing and shifting model (only in the intervention group) exclusion criteria: * protected patient according to the public health regulation, * patient unable to fill the survey, * non-availability of the physiotherapist to receive the patient (only in the intervention group)

Keywords: task-sharing task-shifting family physician physiotherapist
study of management alterations resulting from cari-heart® technology in patients undergoing coronary computed tomography angiography (ccta) for the evaluation of coronary artery disease: a united states based multi-centre study (smart-ccta-1)

Conditions: Cardiovascular Diseases

Summary: this study is an assessment of the impact of cari-heart® on the clinical management of patients across at least three centres in the usa. this study is an observational study, in which clinicians will be presented with a patient's ccta scan results and relevant clinical details (such as blood test results and clinical risk factors) with the resulting clinical management recommendation recorded; they will then be presented with the results of the cari-heart® analysis alongside any other relevant clinical details and any changes in clinical management recommendation will be recorded.


Eligibility criteria:
inclusion criteria: * clinically indicated ccta undertaken for evaluation of coronary artery disease. exclusion criteria: * history of surgical revascularization (coronary artery bypass graft, cabg) * ccta undertaken for structural heart disease evaluation (e.g. transcatheter aortic valve replacement (tavr) * the ccta is of poor quality or partly unanalyzable due to artifacts, such as motion-artifacts, breathing-artifacts, stack-artifacts or blooming-artifacts.
a study of ym178 in patients with symptomatic overactive bladder

Conditions: Urinary Bladder, Overactive

Summary: examine which dose of ym178 is the best in terms of efficacy, safety and tolerability compared to placebo

to investigate the dose-response relationship of ym178 in terms of efficacy, safety and tolerability, and also the superiority of ym178 over placebo.

Eligibility criteria:
inclusion criteria: * patients over 20 years suffering from overactive bladder exclusion criteria: * pregnant and breastfeeding women * any clinically significant abnormal conditions which in the opinion of the investigator makes the patient unsuitable for the study

Keywords: ym178 urinary bladder, overactive
outcomes of patients with foraminal stenosis

Conditions: Lumbar Foraminal Stenosis

Summary: the present study was to see the effect of minimally invasive neural foraminotomy for lumbar foraminal stenosis with unilateral radicular pain. traditionally, fusion was was done for the patients, but recent development enable surgeon to decompress neural foramen without rigid spinal fusion. although, clinical effect of neural foraminotomy may have limitation in attaining a comparable result to fusion surgery, a cost-effective analysis may reveal a result in a different perspective. in this regard, we designed a prospective cohort study to see the cost-effectiveness of neural foraminotomy compared to fusion surgery.

control: 1-2 levels fusion surgery intervention: neural foraminotomy inclusion patients between 40 - 100 years. no improvement despite nonsurgical treatment for more than 3 months. no history of lumbar fusion surgery single or double-level lumbar foraminal stenosis with corresponding leg pain exclusion severe neurological deficit (motor grade less than grade iii) combined inflammatory joint disease combined neurodegenerative disease such as parkinson's disease or dementia combined cancer, traumatic fracture marked spinal deformity (c7 sagittal vertical axis \> 10cm) surgery and follow-up patients underwent foraminotomy and visits outpatient clinical at determined time points (postoperative month 1, 6, 12 and 24 months) their clinical outcomes were recorded at each visit. their medical costs were retrieved at the time of analysis by using hospital records. statistical analysis means: t-test

Eligibility criteria:
inclusion: * patients between 40 - 100 years. * no improvement despite nonsurgical treatment for more than 3 months. * no history of lumbar fusion surgery. * single or double-level lumbar foraminal stenosis with corresponding leg pain exclusion: * severe neurological deficit (motor grade less than grade iii) * combined inflammatory joint disease * combined neurodegenerative disease such as parkinson's disease or dementia \* combined cancer, traumatic fracture * marked spinal deformity (c7 sagittal vertical axis \> 10cm)

Keywords: cost-effectiveness surgery deformity
dietary phytosterols and human aortic valve

Conditions: Hypercholesterolemia; Atherosclerosis

Summary: this randomized controlled double-blind intervention study unravels influence of dietary plant sterols and stanols on the structure and the sterol composition of the human aortic valve. the study patients will include 50-60 voluntary patients from the helsinki univ. central hospital, who will undergo aortic valve surgery. the patients will be randomized into plant sterol (e), plant stanol (a) and control (c) groups. patients in the e and a groups will be asked to consume daily 2 grams plant sterols or plant stanols, respectively, in a margarine product.

high level of serum cholesterol is a risk factor for atherosclerotic complications, including atherosclerotic aortic valve disease. over 50 years dietary plant sterols have been used to inhibit intestinal cholesterol absorption and to decrease its levels in serum. daily human diet contains numerous different plant sterols, of which sitosterol and campesterol are the most abundant ones. few epidemiologic studies suggest that sitosterol and campesterol may also be involved in formation of atherosclerotic changes in human arteries. the saturated forms of sitosterol and campesterol, i.e., the plant stanols (mainly sitostanol and campestanol) are beneficial with this respect. as part of daily diet, the plant stanols decrease absorption of both cholesterol and plant sterols, and thus, are putatively even more effective in prevention of atherosclerosis than the respective plant sterols. our double-blind controlled intervention study unravels influence of dietary plant sterols and stanols on the structure and the sterol composition of the human aortic valve. 50-60 patients, who will undergo aortic valve surgery, will be asked to volunteer our study. the patients will be randomized into three groups: (a) a group consuming margarine containing daily 2 grams plant stanols, (e) a group consuming margarine containing daily 2 grams of plant sterols, (c) a control group consuming margarine without any plant sterols or stanols. the dietary intervention will last for 4 to 8 weeks from the randomization to the operation. serum samples for analyses of serum lipids, lipoproteins and sterols will be collected at the randomization and at the operation. the atherosclerotic aortic valve will be examined with respect to its composition of cholesterol, other sterols and stanols. the aim of our study is to elucidate the effects of dietary consumption of plant sterols and stanols on the sterol composition and structure of the atherosclerotic disease-affected aortic valve in human patients.

Eligibility criteria:
inclusion criteria: * atherosclerotic aortic valve disease needing an aortic valve replacement operation exclusion criteria: * none

Keywords: atherosclerosis plant sterols plant stanols aortic valve
redscar © application for detection of infected surgical wounds

Conditions: Surgical Wound Infection; Surgical Wound; Surgical Site Infection

Summary: surgical site infection (ssi) is the second cause of healthcare-associated infections (hais). its appearance increase mobidity and post-operatice hospital stays, increasing costs aswell, although its one of the most preventable hai. the diagnosis and detection of ssi is usually carried out late by non-especialists once the patient has consulted to the emergency services or primary care with an already obvious infections. this raise both the direct and indirect costs and saturaties the emergency department and primary care, while delays treatment and increase disconfort and morbidity. a smart phone aplication (redscar© ) was developped in order to detect and monitor wound infection remotely based on an automated algorithm with no medical intervention.this app allows the patient to upload a photography and answer a short questionary, the aplication will then give a diagnosis of possible infection and recommendations. this study is the first one to use a smartphone-based automatic aplication on real patients to diagnosis wound infection . this is a prospective, single-institution not randomized quasy-experimental study protocol. the study design and protocol were reviewed and approved by research ethics committee of the balearic islands (cei-ib). this paper is part of the r+d+i project pid2020-113870gb-i00- "desarrollo de herramientas de soft computing para la ayuda al diagnóstico clínico y a la gestión de emergencias (hesocodice)", funded by mcin/aei/10.13039/501100011033/.


Eligibility criteria:
inclusion criteria: * signature of written consent. * age over 18 years. * emergency and scheduled surgery inpatients who have undergone abdominal surgery using staples to close the wound. * access to an android-based smartphone device, able to download the app and understand its management. * possibility of in person revision on the tenth postoperative day. exclusion criteria * patients who do not have access to a compatible smartphone or who are not able to use the app correctly (not being familiar with mobile devices or inability to understand how the app works or the questions asked). * no written consent. * impossibility of personal revision.

Keywords: surgical wound infection telematic follow-up i-health
technology assisted treatment for trichotillomania

Conditions: Trichotillomania

Summary: trichotillomania is characterized by recurrent hair pulling resulting in hair loss causing significant distress and impairment which persists despite repeated attempts to stop. behavioral based therapies focused on increasing awareness of hair pulling followed by the use of an incompatible behavior have proven effective. in an effort to enhance awareness, a wrist worn motion detection device and a companion mobile application was created. in this study, we will test the initial efficacy of the habitaware device and accompanying app as a system for delivering self-administered habit reversal training (hrt).


Eligibility criteria:
inclusion criteria: * willingness to participate; * current diagnosis of ttm (as assessed via tdi); * regular access to a smartphone with gps capabilities (i.e., available for completing assessment probes throughout the day); exclusion criteria: * currently receiving psychotherapy * other psychiatric condition requiring more immediate care * have previously used any behavior awareness devices (e.g. keen)

Keywords: hair pulling disorder body-focused repetitive behaviors trichotillomania
delayed mycophenolate mofetil in single-donor islet allotransplantation in type 1 diabetes

Conditions: Type 1 Diabetes; Hypoglycemia

Summary: the objective of this study is to assess the safety and efficacy of islet allotransplantation for the reestablishment of stable glycemic control in patients with type 1 diabetes, using anti-thymocyte globulin induction immunosuppression with sirolimus, mycophenolate mofetil and low dose tacrolimus maintenance immunosuppression.

to assess the safety and efficacy of a new single-donor islet allotransplant protocol focusing on minimization of ischemic damage by the two-layer pancreas preservation technique, attenuation of posttransplant nonspecific inflammatory responses by etanercept and anti-thymocyte globulin, deletion/inactivation of autoreactive t cells by anti-thymocyte globulin and daclizumab induction immunotherapy, and potent yet non-diabetogenic maintenance immunosuppression with sirolimus and delayed mycophenolate mofetil instead of tacrolimus for the reestablishment of stable glycemic control in recipients with type 1 diabetes.

Eligibility criteria:
inclusion criteria: 1. primary islet allotransplant 2. type 1 diabetes mellitus, complicated by at least one of the following situations that persist despite intensive efforts in close cooperation with their diabetes care team: 1. metabolic lability/instability; 2. reduced awareness of hypoglycemia; 3. persistently poor glucose control (as defined by hgba1c\>10% at the end of six months of intensive management efforts with the diabetes care team); 4. progressive secondary complications. 3. age 18 and older 4. able to give written informed consent exclusion criteria: 1. known hypersensitivity to rabbit proteins. 2. presence of history of panel-reactive anti-hla antibodies (\>10%). 3. insufficient cardiovascular reserve. 4. creatinine clearance \<60 ml/min/m2. 5. portal hypertension, abnormal liver enzyme tests, or history of significant liver disease. 6. history of malignancy within 5 years. 7. active peptic ulcer disease. 8. severe unremitting diarrhea or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications. 9. pregnancy or breast-feeding. 10. active infections. 11. serological evidence of infection with hiv, or hbsag or hcvab positive within the previous 12 months prior to transplantation. 12. negative screen for epstein-barr virus (ebv) by an ebna method 13. evidence of infiltrate, cavitation, or consolidation on chest x-ray during pre-study screening. 14. schizophrenia, bipolar disorder, or major depression that is unstable or uncontrolled on current medications. 15. ongoing substance abuse; drug or alcohol. 16. recent history of noncompliance. 17. any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
evaluation of a six-session psycho-education group program

Conditions: Eating Disorders; Personality Disorders

Summary: the aim of this project is to analyze the impact of a psycho-educational group program on the family members and close friends of persons with eating disorders and co-morbid personality disorders.

the aim of this project is to analyze the impact of a six session psycho-educational group program on the family members and close friends of persons with eating disorders and co-morbid personality disorders. measurements: general health, perceived caregiver burden, and relation to the patient at the following point of time: pre -, post- and follow up, with waiting list control.

Eligibility criteria:
inclusion criteria: * relatives and close friends to persons receiving treatment for their eating disorder and comorbid personality disorder. * \> 18 years, * speak and understand norwegian language, and * informed consent to participate for both relative and patient.

Keywords: psycho-education eating disorders personality disorders relatives and close friends caregiver burden
the fast oct study

Conditions: Tomography, Optical Coherence; Myocardial Revascularization; NSTEMI - Non-ST Segment Elevation MI; Unstable Angina; Coronary Arteriosclerosis; 3D-angio-based FFR

Summary: this trial is designed to associate angiography-based fractional flow reserve (3d-angio-based ffr) values with optical coherence tomography findings in pre- and post-percutaneous coronary intervention in patients with non-st segment elevation acute coronary syndromes.

prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study, enrolling up to 200 patients with intermediate to severe coronary stenosis (30-90% diameter stenosis) in patients presenting with nst-acs requiring coronary angiography assessment. patients will receive ad-hoc oct evaluation of the target vessels and offline 3d-angio-based ffr evaluation. the primary study parameter is the association between 3d-angio-based ffr values and oct detected minimum luminal area pre- and post-pci

Eligibility criteria:
inclusion criteria: * 18 years or older * presenting with nst-acs * at least one coronary vessel with intermediate to severe coronary stenosis (30% to 90% by visual estimation or online qca) * target vessel with a reference vessel diameter (rvd) ≥2.5 and ≤ 5.0 mm as assessed by qca or visual estimation * the patient is willing to participate in the study * target vessel suitable for oct imaging exclusion criteria: * target vessel with a distal thrombolysis in myocardial infarction (timi) flow \<3 * target lesion located within 5.0 mm of vessel origin * severe tortuosity * chronic total occlusion of the target vessel * target lesion is located in or supplied by an arterial or venous bypass graft. * impaired renal function (egfr \<30ml/min) \* * pregnant or breastfeeding patients \* * patient has a known allergy to contrast medium \* * contraindication for the use of nitrates \* * life expectancy \<12 months

Keywords: oct 3d-angio-based ffr coronary arteriosclerosis nst-acs