Kornimate/medical-research-clean huggingface dataset:
integrated mental health care and vocational rehabilitation to people with to common mental disorders

Conditions: Common Mental Disorders; Depression; Anxiety; Personality Disorders; Functional Disease Present; Stress

Summary: the purpose of this study is to investigate the efficacy of an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression, stress, anxiety, personality- and functional disorders in denmark

background: mental illness has an estimated financial burden on the danish economy of 3.4 % of gross national product every year due to lost productivity, social benefits and healthcare costs and approximately 50 % of people receiving long-term sickness benefits have a common mental illness. furthermore, a significant treatment gap exists where less than 30% were treated for their mental illness. objective: the primary objective of the randomized trial is to examine whether people on sick leave with a diagnosis of anxiety, depression, stress, personality disorders or functional disorders, return to work faster and have a higher job retention if they receive an integrated and optimized vocational rehabilitation and mental health care intervention, compared to people who receive the standard mental health care and vocational rehabilitation service. method: the trial is designed as an randomized, two-group parallel, assessor-blinded, multisite trial. a total of 800 participants with a common mental illness will randomly be assigned into two groups 1) ibbis ii, consisting of an integrated mental health care and vocational rehabilitation; or 2) service as usual, at two sites in denmark. the primary outcome is difference between the two groups in time to return to work at 12 months. results/discussion: this study will contribute with new knowledge on vocational recovery and integrated vocational and health care interventions in a scandinavian context.

Eligibility criteria:
inclusion criteria: - inclusion criteria * anxiety, depression, stress, personality disorder or functional disorder diagnosed at a structured diagnostic interview based on the mini international neuropsychiatric interview conducted by the ibbis team * sickness benefit recipient at baseline; on sick leave from job or unemployed for a minimum of four weeks * resident in copenhagen or aarhus municipalities * speak sufficient danish to participate in interviews and complete questionnaires without an interpreter * aged 18 or older * has given informed written consent exclusion criteria: * pregnant * high degree of suicidal ideation * dementia * abuse of alcohol or other drugs to the degree that participation in therapy is not possible * a need for mental health treatment in secondary sector care * unstable somatic condition that is too severe for participation in the project * the participant will not refrain from participating in other psychotherapeutic treatment outside the ibbis project if the participant will be allocated to the experimental group

Keywords: vocational rehabilitation mental health services return to work
detection of silent aspiration events utilizing ph/impedance probes in hospitalized patients

Conditions: Acid Aspiration Syndrome

Summary: monitoring and quantification of reflux events in high risk critically ill inpatients and lower risk general medical/surgical inpatients, with comparison to relevant clinical variables.

the investigators will conduct a pilot prospective cohort study of the incidence of reflux of gastric contents into the esophagus and the correlation with clinically evident aspiration events. the investigators will demonstrate that an esophageal multichannel ph/impedance probe can be used safely and effectively in an inpatient population to monitor reflux of acidic and non-acidic contents into the esophagus. the investigators will determine the frequency and severity of reflux events in a 24 hour period in two hospitalized patient populations: general medicine patients on the wards and critically ill patients in the intensive care unit. the investigators will then examine the relationship between the documented reflux events and clinically apparent aspiration events. the incidence of these silent reflux events in hospitalized patients is currently unclear.

Eligibility criteria:
inclusion criteria: 1. age greater than 18 years 2. admitted to medical-surgical floor or medical intensive care unit exclusion criteria: 1. patients with contraindication to nasogastric tube placement (facial trauma, active epistaxis, abnormal nasopharyngeal or facial anatomy, esophageal stricture or injury, esophageal varices) 2. patients requiring non-invasive positive pressure ventilation 3. patients with uncontrolled vomiting 4. patients with planned or anticipated airway or esophageal procedure within the 24-hour monitoring period 5. patients not expected to survive for 24 hours or those receiving hospice/palliative care

Keywords: aspiration reflux
budesonide orodispersible tablet vs. placebo in active eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: the purpose of this study is to prove the superiority of a 6-weeks treatment with budesonide effervescent tablets versus placebo for the induction of clinico-pathological remission in patients with acute eosinophilic esophagitis.


Eligibility criteria:
inclusion criteria: * signed informed consent, * male or female patients, 18 to 75 years of age, * confirmed clinico-pathological diagnosis of eosinophilic esophagitis (eoe) according to established diagnostic criteria * active symptomatic and histological eoe, * a documented trial with proton pump inhibitors (ppis) in order to rule out ppi-responsive esophageal eosinophilia, * negative pregnancy test in females of childbearing potential at baseline visit. exclusion criteria: * clinical and endoscopic signs of gastroesophageal reflux disease (gerd), * history of abnormal results in case of an optionally performed ph-monitoring of the distal esophagus, * patients with ppi-responsive esophageal eosinophilia * achalasia, scleroderma esophagus, or systemic sclerosis, * other clinically evident causes than eoe for esophageal eosinophilia, * any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection \[candida esophagitis\]), * any relevant systemic disease (e.g., aids, active tuberculosis), * if careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection, * liver cirrhosis or portal hypertension, * history of cancer in the last five years, * history of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit, * upper gastrointestinal bleeding within 8 weeks prior to screening visit, * existing or intended pregnancy or breast-feeding.
d-cycloserine adjunctive treatment for posttraumatic stress disorder (ptsd) in adolescents

Conditions: Posttraumatic Stress Disorder; PTSD

Summary: the purpose of this study is to show whether d-cycloserine in combination with cognitive behavioral therapy (cbt) is more effective than cbt plus placebo to reduce symptoms of posttraumatic stress disorder (ptsd) in 13-18 year-old children.

while most individuals with ptsd treated with cognitive behavioral therapy (cbt) show improvement, they still have some enduring symptoms and functional impairment. accordingly, there is a need for treatment advances. d-cycloserine (dcs), an antibiotic that has been used for over 50 years, has also been found to have positive effects on cognition and anxiety. dcs was found to enhance learning and memory, and also facilitates extinction of fear reactions. however, dcs only produces an extinction effect when paired with behavioral training, not when simply given alone. thus, the medication only needs to be given for seven doses in this research and youth do not need to take the medication long term. the research also includes a three-month follow-up.

Eligibility criteria:
inclusion criteria: * certain number of ptsd symptoms plus functional impairment * must be able to swallow pills exclusion criteria: * serious kidney or liver disease * epilepsy * bipolar disorder * psychosis

Keywords: cognitive behavior therapy children adolescents pharmacotherapy
a phase 1b study evaluating amg 232 alone and in combination with trametinib in acute myeloid leukemia

Conditions: Advanced Malignancy; Cancer; Oncology; Oncology Patients; Acute Myeloid Leukemia

Summary: open-label, sequential dose escalation and expansion study of amg 232 in subjects with acute myeloid leukemia.


Eligibility criteria:
inclusion criteria: * men or women \> 18 years old * pathologically-documented, definitively-diagnosed aml that is relapsed or refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy * ability to take oral medications and willing to record daily adherance to investigational product * adequate hematological, renal, hepatic, and coagulation laboratory assessments exclusion criteria: * active infection requiring intravenous (iv) antibiotics * prior participation in an investigational study (procedure or device) within 21 days of study day 1 * major surgery within 28 days of study day 1 * anti-tumor therapy within 14 days of study day 1

Keywords: aml
yoga for kyphosis trial

Conditions: Kyphosis

Summary: this study seeks to determine whether a specially designed hatha yoga program can reduce hyperkyphosis in men and women who are at least 60 years of age and who have excessive thoracic kyphosis.


Eligibility criteria:
inclusion criteria: * age 60 years or greater * willingness to accept randomization * adult-onset hyperkyphosis (noticed after age 50) * measured debrunner kyphometer angle \>40 degrees exclusion criteria: active angina; uncontrolled hypertension (sbp greater than 160 or dbp greater than 90); high resting pulse or respiratory rate (hr \>90 or rr\>24 after 5 minutes seated); current unstable asthma or exacerbated chronic obstructive pulmonary disease; cervical spine instability; unstable knee or shoulder joints; hemiparesis or paraparesis; use of assistive walking device or wheelchair; unable to hear or see adequately for participation in yoga classes; unable to comprehend and follow directions (in english); unable to attend in-person classes; likely to move within the year after screening; has not had check-up by health care provider within 12 months (if not taking any prescription medications) or in the past 6 months (if any regular medicines taken) and is not willing to do so prior to enrollment; cannot pass physical safety tests. physical safety was assessed as the ability to stably execute each of the following movements without human assistance: transition from standing to recumbent on the floor and get up from the floor to standing; lift both arms to shoulder level without losing balance; stand with feet side-by-side for 30 seconds; and stand with feet hip-width apart for 60 seconds.

Keywords: kyphosis yoga aging physical performance quality of life
effects of motor imagery and action observation training on neck reposition sense in patients with chronic neck pain

Conditions: Chronic Pain

Summary: this study evaluates the influence of motor imagery or action observation training on joint position error in patients with chronic neck pain. this variable is a measure of proprioception and cervical motor control. a group of patients will receive an action observation training of neck movements, another will receive a protocol of motor imagery of the same movements and the last group will be a placebo group, through the viewing of a documentary video.

motor imagery is defined as a dynamic mental process of an action, without its real motor execution. action observation training consists of watching an action performed by someone else. both motor imagery and action observation have been shown to produce a neurophysiological activation of the brain areas related to the planning and execution of voluntary movement in a manner that resembles how the action is performed in reality. both motor imagery and action observation are interventions that can generate adaptive neuroplastic changes on a cortical level, leading to a decrease in chronic pain. these rehabilitation techniques are used in pain treatment and impaired movement injuries that could be due to a nervous system alteration. the effectiveness of motor imagery is controversial; several studies have presented unfavorable outcomes from this technique. some variables, such as the duration of the sessions, the time employed the type of motor task or the number of sessions can influence the outcomes of these studies. thus, it is necessary to clarify the controversial aspects of motor imagery, which lead us to perform this study.

Eligibility criteria:
inclusion criteria: * men and women aged between 18 and 65 years * medical diagnosis of nscnp with more than 6 months of evolution of neck pain exclusion criteria: * patients with rheumatic diseases, cervical hernia, cervical whiplash syndrome, neck surgeries o a history of arthrodesis * systemic diseases * vision, hearing or vestibular problems * severe trauma or a traffic accident that had an impact on the cervical area.

Keywords: motor imagery action observation
balance and mild traumatic brain injury: the effect of a weighted compression vest

Conditions: Mild Traumatic Brain Injury

Summary: after a mild traumatic brain injury (mtbi) people often report balance problems. at parkwood hospital we have noticed that balance is improved when patients with mtbi wear a weighted compression vest. this follow up pilot study looks at the immediate effects of weighted compression vests on participants with altered balance after mtbi. participants will be recruited from the ministry of health outpatient acquired brain injury (abi) program wait list. then each participant will perform a series of balance and walking tests under 2 conditions : 1) wearing a weighted compression vest , 2) not wearing a weighted compression vest. it will be randomized whether participants wear the vest on the first or second testing day. participants will also be asked how confident they are about their balance and how anxious they felt performing the assessments after each testing session. we hypothesize that the weighted compression vest will improve fatigue and anxiety immediately and 24 hours after performing a complex task, and will improve static and dynamic balance, gait variability, and walking speed in patients with mtbi, during the tasks.


Eligibility criteria:
inclusion criteria: * diagnosed concussion. symptoms persistent for more than 3 months. self-reported balance deficits. participants have been referred by a physician to the outpatient abi team at parkwood. participants have been screened by the abi team and are currently awaiting treatment. no other diagnosed orthopedic injuries or significant health conditions. able to follow instructions exclusion criteria: * other pre-existing vestibular problems. other diagnosed orthopedic injuries or significant health conditions that impair balance or mobility.

Keywords: physiotherapy physical therapy neurotrauma rehabilitation rehabilitation balance balance confidence concussion post-concussion mild traumatic brain injury
at-007 in adult subjects with classic galactosemia (cg)

Conditions: Classic Galactosemia

Summary: this study is a 12-month open-label extension (ole) study of at-007 in adult subjects with cg who previously participated in study at-007-1001 part d and/or part d extension. the study is designed to assess the long-term safety of at-007 in subjects with cg as well as the pharmacodynamics (pd) (inhibition of galactitol) and pk of at-007. the effect of 12-month treatment with at-007 on the levels of galactose and other galactose metabolites in subjects with cg will also be evaluated.

primary: - to evaluate the long-term safety of 12-month oral administration of at-007 in adult subjects with classic galactosemia (cg) secondary: * to evaluate the long-term inhibition of galactitol, a biomarker of aldose reductase (ar) activity, induced by 12-month oral administration of at-007 to adult subjects with cg * to evaluate the pharmacokinetic (pk) parameters of 12-month oral administration of at-007 in adult subjects with cg exploratory: * to evaluate the effect of 12-month oral administration of at-007 on the levels of galactose and its other metabolites in adult subjects with cg * to evaluate the burden of illness (boi) of adult subjects with cg * to evaluate quality of life (qol) measures of adult subjects with cg * to evaluate the effect of 12-month oral administration of at-007 on the boi and qol of adult subjects with cg

Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating female subject with a cg diagnosis * previous participation in study at-007-1001 part d and/or part d extension * no other significant health problems which preclude participation exclusion criteria: * concomitant use of certain medications or over-the-counter therapies * discontinuation from study at-007-1001 part d and/or part d extension due an adverse event
validity and reliability of a self-evaluation tool for cognitive deficits in the acute stage after stroke

Conditions: Stroke, Acute; Cognitive Dysfunction

Summary: cognitive disorders are common early after stroke but can be overseen in patients with mild stroke who seem to be functionally recovered but are at risk to experience difficulties in advanced daily activities affecting social, vocational and family responsibilities. acute stroke units admit a large number of patients and adequate referral to rehabilitation services is essential in terms of quality of care. a self-evaluation tool to evaluate cognitive function was developed by the occupational therapy department. patients with mild strokes and pre-stroke independent for instrumental daily activities fill out this self-evaluation tool, which is a paperwork task. semi-structured interpretation is performed by physician and may result in referral to the occupational therapist for comprehensive evaluation. in this study the validity and reliability of the self-evaluation tool will be examined.


Eligibility criteria:
inclusion criteria: * diagnose of stroke * written consent * age 18 years or older * less than 1 week after stroke onset exclusion criteria: * not able to write/read * not able to understand dutch * unilateral motor deficit in upper limb (nihss score for upper limb +2) * referred to stroke unit with transcient ischemic attack

Keywords: occupational therapy evaluation tool
remote ischemic preconditioning in aortic valve surgery

Conditions: Aortic Valve Stenosis

Summary: rip-valve is a randomized, single blinded study that will test the hypothesis that remote ischemic preconditioning initiated before surgery reduces post-operative myocardial damage in aortic valve surgery. infarct size will be determined by 72 hours area under curve of troponin-i.

the hypothesis tested in this research proposal is that remote ischemic preconditioning initiated immediately before aortic valve surgery reduces myocardial damage related to surgery.

Eligibility criteria:
inclusion criteria: * age \> 18 * aortic valve surgery for aortic stenosis * written informed consent exclusion criteria: * aortic valve surgery combined with cabg or an other valve surgery * previous q-wave myocardial infarction or previous coronary artery bypass graft * coronary artery stenosis \>70% * ejection fraction \<35% * surgery performed in emergency * nicorandil ou metformin treatment within 8 days before surgery * patient refusal / patient not having provided written informed consent.
treatment utility of postpartum antibiotics in chorioamnionitis

Conditions: The Primary Outcome of This Study Will be the Rate of Endometritis

Summary: to determine if prophylactic postpartum antibiotics are required post-cesarean delivery for pregnancies with treated chorioamnionitis.

bacterial infection of the amniotic cavity, termed "chorioamnionitis", is a major cause of perinatal mortality and maternal morbidity. early administration of broad-spectrum antibiotic therapy in the laboring patient with chorioamnionitis has both neonatal and maternal benefits. less known is the ideal postpartum antibiotic regimen - or if postpartum antibiotics are even required at all - needed to decrease febrile morbidity. current practice has seen a wide range of practice styles ranging from no treatment to antibiotic prophylaxis for up to 48 hours after delivery. if antibiotics are prescribed, there is good evidence to support one additional dose of antibiotics as compared to 24 hour dosing to decrease the rate of endometritis. less clear is whether antibiotics are required at all for the properly treated patient with chorioamnionitis who requires a cesarean delivery. one study comparing continued antibiotics versus no-treatment failed to show a difference in the rate of postpartum endometritis. the conclusion from this study was that continuation of preoperative clindamycin and gentamicin in the postoperative period did not reduce the risk of endometritis compared to a single preoperative dose however this study was terminated early due to failure to recruit their stated sample size. puerperal endometritis rates vary by mode of delivery but it is known that the rate is lower in vaginal deliveries as compared to cesarean delivery. the patient with chorioamnionitis that requires a cesarean delivery makes an excellent study target. given the lack of studied protocols, there currently are many acceptable methods for treating the patient with chorioamnionitis. our proposed study plans to evaluate the two most common methods of treatment to determine the most effective regimen. if post-delivery antibiotics do not show a benefit to these highest risk subjects, it is likely inferred that patients that undergo a vaginal delivery will not require antibiotics as well. specific aims there is conflicting data regarding the necessity of post-delivery antibiotics for patients with chorioamnionitis who undergo cesarean delivery. the primary objective of this study is to determine if postpartum antibiotics are necessary for antepartum treated cases of chorioamnionitis in patients undergoing a cesarean section.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chorioamnionitis * undergoing cesarean section for delivery exclusion criteria: * multiple gestations, * allergy to beta-lactam antibiotics * patients with estimated creatinine clearance (clcr) less than 70 ml/min * maternal fever explained by etiology other than chorioamnionitis * inability to comply with the study protocol.