Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and efficacy of ts-121 as an adjunctive treatment for major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the safety, tolerability, and efficacy of ts-121 as an adjunctive treatment for patients with major depressive disorder with an inadequate response to current antidepressant treatment (ssri, snri or bupropion).


Eligibility criteria:
inclusion criteria: 1. adult males and females between 18 and 65 years of age inclusive (at time of initial informed consent) 2. patients with a current diagnosis of mdd by dsm-5, confirmed through a structured interview using mini 3. patients who receive the same antidepressant (ssri, snri or bupropion monotherapy) for at least 6 weeks of continuous treatment with at least 4 weeks on a fixed dose 4. patients who willing to remain on the same primary ssri, snri or bupropion and fixed dose throughout the course of the study 5. patients who meet the total score on the ham-d as listed below 1. ham-d ≥ 18 at screening 2. ham-d ≥ 18 at baseline 6. body mass index (bmi) ≥ 18 and ≤ 38 kg/m2 exclusion criteria: 1. patients with inadequate response to ≥2 prior antidepressant treatments (not including current antidepressant) of at least 4 weeks duration each for the current episode 2. patients whose current depressive episode is diagnosed with psychotic features, catatonic features, post-partum (primary onset), or is secondary to a general medical disorder 3. patients with a diagnosis of any of the following dsm-5 class disorders 1. schizophrenia spectrum and other psychotic disorders 2. bipolar and related disorders 3. anxiety disorders \[co-morbid gad and sad will be allowed in the study if the primary diagnosis is mdd, and if in the opinion of the investigator, the comorbid anxiety is not likely to interfere with the subject's ability to participate in the trial or affect study outcome\] 4. obsessive-compulsive and related disorders 5. trauma- and stressor-related disorders 4. patients who received electroconvulsive therapy (ect) within 12 months of screening, received more than one course of ect in their lifetime or plan to receive ect during the study 5. patients who received repetitive transcranial magnetic stimulation (rtms) within 12 months of screening or plan to receive rtms during the study 6. patients who plan to initiate or terminate cognitive or behavioral psychotherapy or alter the frequency of ongoing therapy during this study 7. patients who have attempted suicide within the past 6 months 8. patients with history or presence of intellectual disability, pervasive developmental disorder, cognitive disorder, neurodegenerative disorder, or brain injury 9. patients with any history or complication of convulsive disorder 10. patients who are undergoing treatment with psychotropic medications, benzodiazepines, metyrapone, lithium and/or corticosteroids 11. patients who are taking moderate to strong cyp3a4 inhibitors/inducers

Keywords: major depressive disorder adjunctive treatment
depression and self-care in heart failure

Conditions: Heart Failure; Depression

Summary: the purpose of the study is to test whether cognitive behavior therapy (cbt) plus heart failure self-care education is superior to "usual care" for depression.

comorbid depression is common in heart failure, but little is known about how to treat it. this randomized, controlled, efficacy trial will compare cognitive behavior therapy (cbt) to usual care (uc) for depression in heart failure. cbt will be integrated with an intervention to improve heart failure self-care, because depression and inadequate self-care are thought to be interrelated problems. it will also be integrated with clinical attention to primary caregiver stress. basic heart failure education will be provided to all participants.

Eligibility criteria:
inclusion criteria: * new york heart association class i, ii, or iii heart failure (clinically diagnosed at least 3 months ago) * meets the dsm-iv criteria for a current major depressive episode, or for current minor depression with a past history of at least one major depressive episode. * phq-9 score of 10 or greater plus 2 or 3 on question 1 or 2 over the last 2 weeks including today exclusion criteria: * less than 30 years old * current etoh / drug abuse * bipolar disorder, schizophrenia, or other psychotic disorder * communication barrier * dementia * currently in competing research protocol * high risk for suicide * insurmountable logistical barriers to laboratory assessment visits * major mobility-limiting physical disability * poor 1 year prognosis not r/t heart failure * hospitalized for heart failure or acute coronary syndrome in last month * initiated antidepressant therapy in the past 4 weeks * current non-study psychotherapy for depression or other psychiatric problem

Keywords: heart failure depression self care cognitive behavior therapy
prevention of hemorrhage after implantation of mechanical circulatory support

Conditions: Heart Failure

Summary: main objective of the study is to demonstrate that a prophylactic treatment with vwf factor concentrate after implantation of continuous-flow left ventricular assist device (cf-lvad) reduces the frequency of clinically significant bleeding within 3 months after implantation in comparison to the usual care. adult patients with functional defects of vwf measured after implantation of continuous lvad are randomly assigned to prophylactic treatment.

this time point was chosen because the bleeding events are maximal within the first 3 months after implantation. * adult patients \> 18 years who need a cf-lvad due to advanced heart failure. * functional to determine the potential indication of wilfactin® in the field of cf-lvad and avoid widespread use and to establish evidence-based recommendation to improve the knowledge of the role of vwf concentrate in bleeding and angiogenesis after cf-lvad implantation and to provide some results about mechanism involved angiogenesis or hemostasis.

Eligibility criteria:
inclusion criteria: * adult patients \> 18 years who need a cf-lvad due to advanced heart failure. * functional defects of vwf measured between day 2 and day 4 after implantation (either pfa-adp closure time \>180 sec and or vwf:act/vwf:ag≤ 0.7) * informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated) exclusion criteria: * treatment with wilfactin® within the last seven days * previous adverse reaction to wilfactin® * absence of functional defects of vwf measured between day 2 and day 4 after implantation (either pfa-adp closure time \>250 sec and or vwf:act/vwf:ag\<0.7) * patient with a known thrombophilia * patient with a known severe bleeding disorder * patient refusal or environment * minor patients * pregnant women

Keywords: acquired von willebrand gastro-intestinal bleeding lvad
distal venous arterialisation of ischemic limb

Conditions: Critical Limb Ischemia

Summary: distal venous arterialisation (dva) improve outcome in patients with nonreconstructible peripheral arterial occlusive disease.

the aim of this study was to estimate validity of distal venous arterialisation (dva) as a limb salvage procedure. this prospective randomized study reported early results of 30 unreconstructible patients with critical limb ischemia (cli) treated during 2009 year at clinic for vascular surgery, clinical center of serbia in belgrade. patients were divided in two groups, 10 treated with dva and 20 conservatively (ct) using antiplatelet drugs.

Eligibility criteria:
inclusion criteria: * absence of any possibility for direct revascularisation due to extensive occlusive disease of crural and pedal arteries * sufficient deep venous system and usable great saphenous vein as a graft for in situ bypass surgery according duplex scanning * localized infective of necrotic process up to the metatarsal level * satisfactory general patient condition exclusion criteria: * advanced lower limb ischemia * venous insufficiency of lower limb

Keywords: unreconstructable peripheral arterial disease
effect of the exclusive enteral nutrition combined with azathioprine for remission of crohn's diseases after surgery

Conditions: Crohn Disease

Summary: for some patients with crohn's diseases undergoing surgery，whether exclusive enteral nutrition(een) could delay the disease relapse needs exploration.the trial will study whether the efficacy of postoperative een could help keeping remission.

for patients with crohn's disease(cd), whether exclusive enteral nutrition(een) following bowel resection and anastomosis could delay the disease recurrence remains unkown. in this study， cd patients after surgery will be divided into two groups: one group is treated with 3 months' een and then turn to normal diet after 3 months; the other group is given with normal diet all through. all patients will be adminstrated with oral azathioprine after surgery. then, the rates of 1 year postoperative endoscopic recurrence will be compared between groups.

Eligibility criteria:
inclusion criteria: * cd patients who undergoing bowel resection with anastomosis exclusion criteria: * patients who had administered with immunomodulators or biological agents patients who were created stoma
defining disease activity in neovascular amd with optical coherence tomography angiography

Conditions: Neovascular Age-related Macular Degeneration

Summary: the purpose of this study is to be able to describe optical coherence angiography (octa) patterns of disease activity and quiescence in eyes that have received treatment. the target population group is patients that have neovascular age-related macular degeneration and have had treatment with aflibercept for this condition. this is a single-site study and does not involve any masking or treatment allocation.

treatment of this condition (neovascular age-related macular degeneration - namd) with aflibercept has transformed the outlook for patients with this sight-threatening disease. in clinical practice, eye doctors commonly use a "treat and extend" approach to treatment in which the interval between aflibercept injections is gradually increased once there is namd disease quiescence. it is uncertain about the ideal retinal imaging biomarkers doctors should use to define disease remission or inactivity; and therefore extend treatment intervals. increased certainty of the ideal biomarker would also avoid stopping treatment too soon. the scan the investigators will be performing (octa imaging) detects blood flow within the choroidal neovascular membrane (cnv) - the immature blood vessel network which causes namd. this scan is therefore a potentially powerful way of determining if the disease is active or quiescent. disease activity on this device can be defined as a blood flow pattern which suggests an active cnv or lesion growth. by better defining disease activity using octa, eye doctors would be more confident in continuing and defining a treatment plan for namd.

Eligibility criteria:
inclusion criteria: * patients over 50 years of age with a diagnosis of namd receiving anti-vegf treatment with no signs of intra-or subretinal fluid on structural oct imaging and with no macular haemorrhage after a minimum of three intravitreal injections * visual acuity in the study eye of 35 early treatment of diabetic retinopathy study (etdrs) letter score or better (6/60 or better) * ability to understand the nature/purpose of the study and to provide informed consent * any ocular condition which would lead to image artefact or poor oct image quality * ability to undergo retinal imaging exclusion criteria: * patients with polypoidal choroidal vasculopathy or pachychoroid * patients in whom imaging of the study eye leads to ungradable octa images. * any condition which, in the investigators' opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule or other study conduct.

Keywords: namd treat and extend aflibercept octa neovascular age-related macular degeneration
phenotypic characteristics of responders to obstructive sleep apnea treatment using mandibular advancement devices

Conditions: Sleep Apnea

Summary: currently, mandibular advancement devices (mad) are recommended by the american academy of sleep medicine (aasm) as the first treatment a line in cases of mild and moderate osas in patients without severe cardiovascular comorbidity and in severe osas when treatment with cpap fails or is rejected. although oral appliances (od) have less impact on ahi reduction, both treatments have been shown to have a similar impact on clinical outcomes, including symptomatology and cardiovascular outcomes. in addition, mad is a treatment that is better tolerated by patients, which results in greater compliance on their part, and therefore a similar efficacy in clinical practice. its mechanism of action consists of maintaining the patency of the upper airway, preventing collapse. they act by correcting the anatomical imbalance of patients with osas, specifically stabilizing and increasing the space of the velopharyngeal airways, reducing their collapsibility. however, the effectiveness of the treatment of this pathology using mad is limited by the inter-individual preference of the results of the treatment and the lack of information in the correct selection of the appropriate patients. in fact, oral appliances are an effective treatment for 60-70% of patients. therefore, the precise selection of patients is essential to optimize the results of mad treatment and thus avoid the necessary costs. this justifies the need to identify phenotypes likely to predict response to mad treatment.


Eligibility criteria:
inclusion criteria: * patients older than 18 years * adult patients with obstructive sleep apnea diagnosed according to the third edition of the international classification of sleep disorders. * apnea-hypopnea index (ahi) of at least 5/hour of sleep. exclusion criteria: * patients with heart disease. * central sleep apnea. * patients who had degenerative pathologies of the temporomandibular joint. * patients who had moderate or advanced periodontal disease. * pregnant patients.

Keywords: sleep apnea syndrome mandibular advancement device
efficacy of l-carnitine versus placebo in the treatment of fatigue in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the objective of this study is to evaluate the efficacy of l-carnitine versus placebo in the treatment of fatigue in multiple sclerosis patients. this study will randomize 60 patients in a cross-over design. this study is sponsored by academic french health institutions.

fatigue is one of the most frequent disabling symptom in multiple sclerosis (ms). l-carnitine is currently used in the symptomatic treatment of fatigue after chemotherapy in patients with cancers. it is also empirically used by numerous ms centers in the treatment of fatigue. however, this practice is not evidence-based (cochrane review 2010). this study will evaluate the efficacy of l-carnitine versus placebo in the treatment of fatigue in ms patients in a randomized double blind national multicenter cross-over trial.

Eligibility criteria:
inclusion criteria: * 18 years old and older * relapsing remitting (rr) secondary progressive (sp) or primary progressive multiple sclerosis according to mcdonald 2005 (polman) ms diagnostic criteria. * affected of fatigue for more than 3 months with global score on modified fatigue impact scale (mfis)\>45. * indication of treatment of fatigue to the appreciation of the neurologist. * expanded disability status scale (edss) not exceeding 6.0. * information and comprehensive agreement signed by patient and the investigator. * subject affiliated to health insurance coverage. exclusion criteria: * patients with serious unstable disease : * recurrent or serious relapses * rapidly ongoing disability impairment in the preceding 6 months * serious or non stabilized depression * patients starting a new disease modifying therapy, immunosuppression or antidepressant therapy less than 3 months ago or not stabilized. * patients with a treatment of fatigue or of other condition that may interfere with fatigue evaluation to the appreciation of the neurologist. * energy drinks consumption or toxicomania. * all other reasons to the opinion of the neurologist that may impair study management, especially patient compliance, neuro-psychological disorders that may input questionnaires filling. * person under protection of the law. * participation in other clinical trials (allowing for exceptions, after recommendation from the scientific council).

Keywords: multiple sclerosis/complications fatigue syndrome chronic/drug therapy
valproate in late life schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this research study is to analyze the effectiveness and tolerability of a medication, valproate ( depakote and depakote er), in individuals age 50 years and older who have schizophrenia.

it is known that up to 30% of individuals with schizophrenia continue to have symptoms even when treated with current fda-approved medications intended to treat their schizophrenia. anticonvulsant medications such as valproate (depakote and depakote er) are known to be effective for related conditions such as bipolar disorder (manic depressive illness), and are also used by some physicians in clinical settings in combination with antipsychotic medications to treat symptoms of schizophrenia. currently depakote and depakote er are approved by the fda to treat bipolar disorder and to treat seizure disorder. this study will test to see if depakote and depakote er may improve symptoms of schizophrenia as well when added to antipsychotic medications.

Eligibility criteria:
inclusion criteria: * must have a diagnosis of schizophrenia as confirmed by the mini * must be on antipsychotic medication * must be age 50 year or older * must be capable of providing written informed consent for study participation. in situations where individuals have guardians of person, guardian and subject must both provide written consent; and * must live in the northeast ohio area. exclusion criteria: * a primary psychiatric dsm axis i diagnosis other than schizophrenia * actively abusing substances; or * medically unstable.

Keywords: schizophrenia anticonvulsants valproic acid valproate
staying connected: a mobile health study with the noona® and mobili-t® systems

Conditions: Oropharynx Cancer

Summary: mobile health applications are an attractive technological solution that facilitates access to care for patients conveniently and efficiently. research has shown that remote mhealth delivery has improved patient reported outcomes of disease severity. while such outcomes have traditionally been collected at one point in time within a clinical setting, the potential exists to now gather patient perspectives remotely. additionally, when combined with a mobile health device, mhealth apps can objectively monitor a treatment plan. before implementing a new technology, it is important to investigate how digital health technologies are best integrated into clinical workflows, and how more than one technology can work together to streamline the process. additionally, it is important to understand the relative benefits of each system from a user perspective and identify how combined data can benefit clinical workflows. therefore, the purposes of this project are to demonstrate how two technology companies can work together to assess the feasibility of implementing two related systems into one care pathway.


Eligibility criteria:
inclusion criteria: * have a diagnosis of head and neck cancer; * will be receiving treatment for head and neck cancer (e.g., +/-surgery, +/- radiation therapy, +/- chemotherapy); * the primary site of their cancer is the oropharynx, as this is the subgroup of patients known to experience dysphagia. exclusion criteria: * have a history of cognitive delay, * history of stroke or traumatic brain injury. * have a beard that they are not willing to shave or partially shave (as the device adheres under the chin, on the surface of the skin). * have an implanted electronic device of any kind, including cardiac pacemakers or similar assistive devices, electronic infusion pumps, and implanted stimulators * have irritated skin or skin with open wounds under the chin; * have an allergy to silver.
using machine learning to optimise the danish drowning formula

Conditions: Drowning; Drowning and Submersion While in Bath-Tub; Drowning and Submersion While in Natural Water; Drowning and Submersion While in Swimming-Pool; Drowning and Submersion Due to Fall Off Ship; Drowning and Nonfatal Submersion; Drowning, Near; Drowning; Asphyxia

Summary: the danish drowning formula (ddf) was designed to search the unstructured text fields in the danish nationwide prehospital electronic medical record on unrestricted terms with comprehensive search criteria to identify all potential water-related incidents and achieve a high sensitivity. this was important as drowning is a rare occurrence, but it resulted in a low positive predictive value for detecting drowning incidents specifically. this study aims to augment the positive predictive value of the ddf and reduce the temporal demands associated with manual validation.

the ddf was published in 2023. it is a text-search algorithm designed to search the unstructured text fields in databases containing electronic medical records to identify all potential water-related incidents. the ddf consists of numerous trigger words related to submersion injury (e.g., "drukn"/ drown, "vand"/water, "hav"/ocean, and "båd"/ boat). an ongoing study showed impressive performance metrics of the ddf as a drowning identification tool when applied to the danish pemr on unrestricted terms. however, the ppv was low for detecting drowning incidents specifically. this study aims to augment the ddf's positive predictive value and reduce the temporal demands associated with manual validation. data are extracted from the danish nationwide prehospital electronic medical record using the ddf and manually validated before entered into the danish prehospital drowning data (dpdd). data from the dpdd from 2016-2021 will be split into 80% (training data) and 20% (test data) and used to train the machine learning. data from the dpdd from 2022-2023 will be used as validation data to calculate the performance metrics for the machine learning.

Eligibility criteria:
inclusion criteria: * the patient must have been experiencing respiratory impairment from submersion or immersion in liquid (including persistent coughing, respiratory arrest, and unconsciousness). * the patient must have been in contact with the danish prehospital emergency medical services. exclusion criteria: * duplets * invalid civil registration number

Keywords: danish drowning formula epidemiology drowning machine learning text search utstein prehospital register database denmark