Kornimate/medical-research-clean huggingface dataset:
rapid adaptation to prevent drug use

Conditions: Substance Use

Summary: using a 2-group, mixed method cluster randomized trial design, this study will compare standard implementation versus rapd implementation strategy in michigan middle schools

background: drug use trends change rapidly among youth, leaving intervention experts struggling to respond to emerging drugs promptly. there is a critical need to advance implementation strategies to optimize system responsiveness to these emerging issues. covid-19 has increased the urgency for implementation science to facilitate rapid, equitable responses using existing treatment and prevention efforts. tier 1 evidence-based interventions (ebis), such as the michigan model for health™ (mmh) lend themselves to addressing emerging trends. the overall objectives of this study are to 1) improve the responsiveness of school-based ebis in addressing urgent issues and 2) find ways to support educators and education systems in implementing updated ebis, attending to unique considerations of low-resource settings. methods: using a 2-group, mixed method, randomized controlled trial design, this pilot study will compare standard implementation versus the rapd implementation strategy to deliver mmh. the rapd implementation strategy was designed based on an after action review (aar) approach in collaboration with community partners to analyze gaps and best practices and identify and test suitable implementation strategies to improve responsiveness to the next urgent drug event.

Eligibility criteria:
inclusion criteria: * schools that fail to meet state standards for implementation (less than 80% of curriculum) and/or face one or more barriers to michigan model for health (mmh) curriculum implementation * schools that have a minimum of 25% of students eligible for free and reduced meals * schools must include 7th-grade classes/students exclusion criteria: * schools that meet state identified fidelity standards (i.e., teaching 80% or more of the curriculum) and do not face barriers to mmh implementation * schools that have fewer than 25% of students eligible for free and reduced meals * schools that do not include 7th-grade education level
shared decision making in dialysis

Conditions: End Stage Renal Disease; Chronic Kidney Diseases

Summary: older patients ≥65 years with chronic kidney disease (ckd) face challenges in decision making about dialysis. these patients report little effort by physicians to elicit treatment preferences, discuss prognoses, or explain the burdens/benefits of dialysis options including conservative management. older patients with ckd often prefer maintaining the quality of life over prolonging life, and many regret their decision to start dialysis: nearly one quarter withdraw from dialysis each year. shared dialysis decision-making requires active engagement between nephrologists and patients to align patient, caregiver, and physician communication around common goals. the proposed study is a pilot randomized cluster trial of a dialysis shared decision-making (dial-sdm) intervention for nephrologists (n=20) and their patients ≥65 years old (n=60) with an estimated glomerular filtration rate (egfr) of ≤ 20 ml/min/ /1.73 m2. nephrologists in the intervention group will receive 3 communication training sessions, delivered by a standardized patient instructor (spi) who enact clinical scenarios and offer feedback. in parallel, patients (and caregivers, if available) will receive 2 coaching sessions provided by health coaches, who will explore each patient's relevant contextual information (values, preferences, and goals), and help them identify and practice important questions for their nephrologist. nephrologists in the control group will provide their patients with usual care. the study outcomes will be assessed during two nephrology office visits and at 6 months.


Eligibility criteria:
inclusion criteria: for nephrologist: * member of strong nephrology group working at strong memorial hospital * treat patients with ckd for patients: * age ≥65 years old * presence of advanced ckd stage 4 or 5 (i.e. e gfr ≤ 20 ml/min) * patient's nephrologist is enrolled in the study, and has seen that nephrologist at least once * speaks english * have not attended a dialysis education class or met with the dialysis education coordinator. * have not made a dialysis decision for caregivers: * self-identified caregiver (per definition:"family member, partner, friend or someone else who is involved with your health care issues, for example, someone who you talk to about personal issues including medical decisions or who comes to doctor appointments with you. this person may also help with routine day-to-day activities, like transportation or paperwork.") * 21 years of age or older. exclusion criteria: for nephrologists: - expecting to leave in six months. for patients: * patient has already been seen by a palliative care clinician or is enrolled in hospice * is already on dialysis * hospitalized at the time of recruitment * cognitive impairment * does not speak english for caregivers: * if support is offered primarily in a professional role (e.g., clergy). * cognitive impairment
efficacy of acupuncture in exercise tolerance in patients with copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: chronic obstructive pulmonary disease (copd) is nowadays the 4th cause of death in the world and it´s expected to become the 3rd cause of death in 2020 and the majority cause of morbidity. besides that, in portugal copd patients become more dependents each day. acupuncture as a reflex therapy it´s carried out through a traditional chinese medicine (tcm) diagnose that will allowed to identify the acupoints. the investigators are interested in to assess acupuncture efficacy on physical exercise tolerance in copd patients.an experimental, controlled, randomized, double blind study was done. patients were recruited according tcm diagnose to optimize potential therapeutic effects.


Eligibility criteria:
inclusion criteria: * copd gold iii,iv; * able to walk; * informed consent signed; * stable medication during last 3 days * exacerbation during 3 months; * chinese diagnose opening principle; * blood pressure "90"180 mmhg/ "100mmhg; respiratory rate "10"30 cpm exclusion criteria: * smoker; * metastasis; * hepatic, * renal or cardiovascular disease; * pulmonary hypertension; * copd symptoms exacerbation during the therapy; * previous acupuncture treatments; * unstable vital signs; * pulmonary rehabilitation in the last 6 months; * needle phobia.
a phase ii study of belinostat in combination with bortezomib in patients with relapsed, refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this open-label study will assess anti-tumor activity and safety of belinostat in combination with bortezomib (velcade®) in multiple myeloma patients refractory to or relapsed from at least one prior bortezomib-containing regimen. subjects will be administered both pxd101 and bortezomib on the same days: i.e. days 1, 4, 8, and 11 of a 3-week cycle, for up to 8 cycles.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma. * status of refractory to or relapsed from at least one prior bortezomib-containing regimen. * progressive disease. * age \>= 18 years. * karnofsky performance status \>= 60% * acceptable liver function: * bilirubin =\< 1.5 x uln (upper limit of normal) * aspartate transaminase (ast) and alanine transaminase (alt) =\< 3 x uln * acceptable hematologic status: * absolute neutrophil count (anc) \>= 1.5 x 109/l * platelet count \>= 100 x 109/l * hemoglobin \>= 9 g/dl * coagulation status pt-inr/ptt =\< 1.5 x uln or in the therapeutic range if on anticoagulation therapy. (pt-inr/ptt= prothrombin - international normalized ratio / prothrombin time) * serum potassium within normal range. * estimated life expectancy greater than 3 months. * signed, written irb (institutional review board)-approved informed consent. exclusion criteria: * non-secretory multiple myeloma or symptomatic amyloidosis. * hypersensitivity to bortezomib, boron, or mannitol. * less than 4 weeks since prior chemotherapy, radiotherapy, endocrine therapy, or immunotherapy, except if disease is rapidly progressing. * less than 4 weeks since prior use of other investigational agents. * serious concomitant systemic disorders (e.g. active infection). * significant cardiovascular disease. * marked baseline prolongation of qt/qtc (corrected qt interval)interval. * central nervous system disorders requiring neuroleptics / anti-convulsants. * peripheral sensory neuropathy of ≥ grade 2 * renal insufficiency defined as a creatinine clearance of \< 30 ml/min. * non-willingness to use effective contraceptive methods for patients of child-bearing age / potential. * pregnant or breast-feeding women. * known hiv positivity. * prior treatment with belinostat (pxd101), or any other hdac (histone deacetylase) inhibitor. * altered mental status which precludes an understanding of the informed consent document.

Keywords: multiple myeloma myeloma plasma cell myeloma bone marrow cancer myelomatosis kahler's disease pxd101 belinostat bortezomib
efficacy of guanfacine and lidocaine combination in trigeminal nerve block for pain management in trigeminal neuropathy

Conditions: Trigeminal Neuralgia

Summary: a phenome-wide association study (phewas) identified an association between a loss of function variant in the human alpha 2b adrenergic receptor gene and trigeminal nerve disorders. guanfacine is the oldest alpha-2 adrenergic agonist in clinical use and is approved for hypertension and attention deficit hyperactivity disorder. we hypothesize that guanfacine will be an effective adjunct to lidocaine for the treatment of neuropathic pain by enhancing and prolonging pain relief due to its activation of alpha-2 adrenergic receptors. the objectives of the study will be to evaluate the efficacy and safety of guanfacine in combination with lidocaine for trigeminal nerve block procedures for pain management in trigeminal neuralgia patients. this study will evaluate the efficacy of guanfacine in reducing acute pain and extending duration of pain relief when delivered in combination with lidocaine as a trigeminal nerve block, measured by visual analog scale (vas) data collected at specific time points after each injection.


Eligibility criteria:
inclusion criteria: * ability to understand and read english * history of painful trigeminal neuropathy with persistent background facial pain severity \> 5/10 on vas * experience pain with a score of greater than 5 on a 0-10 scale (vas) in the previous 24 hours before procedural treatment and at the time of procedural treatment. * eligible for trigeminal nerve block procedure and have not had a trigeminal nerve block procedure for pain management prior to the enrollment in the current study. * able to provide informed consent. exclusion criteria: * presence of a significant structural lesion (e.g., tumor) as the cause of pain as shown in at least one neuroimaging study. * current diagnosis of fibromyalgia, temporomandibular disorders (tmd), odontogenic pain or other orofacial pain deemed unrelated to the trigeminal nerve as the origin. * allergy or any other hypersensitivity reactions to guanfacine or lidocaine or local anesthetic of the amide type, or to both iodinated contrast and gadolinium contrast. * females who are pregnant or breastfeeding and/or plan to become pregnant or to breastfeed during study participation. * participation in another investigational drug study within 30 days before randomization. * inability to understand the requirements of the study, inability to abide by the study restrictions, inability to fill out the questionnaires, or inability to return for the required treatments. * any clinically significant medical or surgical condition that in the investigator's opinion could interfere with the administration of study drug, interpretation of study results, or compromise the safety or well-being of the subject (i.e. infection, unable to stop anticoagulants). * no reliable access to telephone service to allow for contact with study personnel.
montelukast in parkinson disease

Conditions: Parkinson Disease

Summary: parkinson's disease (pd) is the second most common neurodegenerative disorder after alzheimer's disease (ad). clinical manifestations of pd can vary, but a formal diagnosis relies on the presence of bradykinesia with rigidity and/or rest tremor according to movement disorder society (mds) criteria for pd. non-motor symptoms, such as hyposmia, constipation, depression, and rapid eye movement (rem) sleep behavior disorder, are common and can in many cases manifest before classical motor symptoms. in later years, more emphasis has been put on non-motor symptoms, especially in the early stages of pd and which is evident in the proposed prodromal pd criterion by mds.

leukotrienes are along with prostaglandins, lipoxins, and thromboxanes included in a group of long-chain fatty acids known as eicosanoids. they are known to play important parts in the inflammatory response such as leukocyte chemotaxis, vascular leakage, and astrocyte proliferation, and were first described by bengt samuelsson and colleagues in 1983. leukotrienes (lt) are synthesized from free arachidonic acid (aa) by the enzyme 5-lipoxygenase (5-lox) into lta4, which is then further metabolized into ltb4, c4, d4, and e4. ltc4, d4, and e4 are grouped by their molecule structure to form the cysteinyl leukotrienes and they mainly activate two receptors, cyslt1 and cyslt2. cyslt1 is a gq/11 family g-protein-coupled receptor with signaling through phospholipase c and ca2+ mobilization

Eligibility criteria:
inclusion criteria: - age ≥ 18 years both male and female will be included negative pregnancy test and effective contraception. diagnosed parkinson's disease patient taking levodopa exclusion criteria: - secondary causes of parkinsonism patients taking anti-inflammatory drugs atypical parkinsonian syndromes prior stereotaxic surgery for parkinson's disease pregnancy and lactation suffering from active malignancy addiction to alcohol and / or drugs known allergy to the studied medications
safety, tolerability and the effects on cerebrospinal fluid spectrin breakdown product-145 levels of abt-957 in subjects with mild alzheimer's disease and mild cognitive impairment

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

Summary: this is a phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose study of abt-957 in participants with mild alzheimer's disease (ad) and mild cognitive impairment (mci) due to ad.


Eligibility criteria:
inclusion criteria: * female participants must have negative results for pregnancy test performed on a serum sample obtained at screening * body mass index is 18.0 to 35.0 at screening * meets the national institute on aging and the alzheimer's association (nia-aa) criteria for probable alzheimer's disease (ad). * meets the nia-aa core clinical criteria for mild cognitive impairment due to ad exclusion criteria: * use of any strong inhibitors of drug metabolizing enzymes within 30 days prior to study drug administration * consumption of alcohol within 24 hours prior to study drug administration * positive screen for non-prescribed drugs of abuse or alcohol * the participant has clinically significant abnormal laboratory values at screening as determined by the investigator * history of a drug or alcohol abuse within 6 months prior to study drug administration * current diagnosis of major depression or other major psychiatric disorder

Keywords: mild cognitive impairment alzheimer's disease
trial of enteral nutrition enriched with eicosapentaenoic acid (epa) in upper gastrointestinal cancer surgery

Conditions: Esophageal Cancer

Summary: this study aims to examine whether providing tube feeding with a formula enriched with omega-3 fats is better than traditional standard tube feeding in terms of preserving nutritional status, improving immune function and reducing medical complications following major upper gut cancer surgery.

title a double blinded randomized controlled trial to investigate the effects of an enteral nutritional supplement enriched with eicosapentaenoic acid on long term nutritional status post operatively specifically the maintenance of lean body mass, and its potential impact on quality of life as well as examining the stress response and immune function and in patients undergoing surgical treatment of esophageal cancer. investigational medicinal product(s): prosure (abbott laboratories) comparator: ensure plus (abbott laboratories) study objectives to examine whether prolonged supplementation with a nutritional supplement enriched with eicosapentaenoic acid is superior to standard nutritional products in terms of promoting anabolism and improving quality of life in patients undergoing surgical treatment of esophageal cancer. study design - prospective randomized controlled trial. primary endpoints: * quality of life scores using eortc questionnaires * nutritional status on day 21 post oesophagectomy and/or total gastrectomy(specifically lean body mass) and at out patient follow up secondary endpoints: * effects on the immuno-inflammatory response to surgery * post operative clinical outcome including sirs, sepsis and organ failure

Eligibility criteria:
inclusion criteria: * adult (male \& female) patients \>18 years with resectable esophageal cancer exclusion criteria: * patients with metastatic disease, * non-operable cases, * patients requiring chemotherapy/radiotherapy early following surgery, * patients with known immunological disorder, * emergency esophagectomy cases, * patients with cardiac, liver or renal failure, * active small intestinal disease eg crohns disease, * allergy to any of the ingredients, * uncontrollable diabetes, * use of medications known to affect eicosanoid metabolism in two weeks prior to trial, * use of fish oil/n-3 fatty acids, * drug abuse, * unable to take preparation for 5 days preoperatively, * pregnant women, * cessation of enteral feeding for longer than 3 consecutive days post operatively for medical/surgical reasons (e.g. chyle leaks).

Keywords: esophageal cancer esophagectomy enteral feeding body composition immunology
shoulder proprioceptive training during immobilization of the wrist

Conditions: Wrist Fractures; Shoulder Pain

Summary: the goal of this randomized clinical trial is to compare how a program of proprioceptive exercises for the shoulder could influence in pain, functionality, quality of life and shoulder muscle overload in people that are undergoing a immobilization period after a wrist fracture. the main questions it aims to answer are: * study the relationship between shoulder muscle overload and shoulder pain. * evaluate the effect of a proprioceptive program on pain and patient's satisfaction. intervention will be: * control group: participants of this group are not going to receive any protocol of exercises during the immobilization period. * experimental group: participants of this group are going to receive a protocol of proprioceptive shoulder exercises to do during the immobilization period. researchers will compare control and experimental group to see if a implantation of a proprioceptive program for the shoulder has benefits on pain, function, quality of life and muscle overload.

distal radius fracture (drf) in one of the most frequent injuries in the upper limb, corresponding to 1/6 of the total fractures of the body. it appears mostly in \>50 years old women (due to osteoporosis and menopause) but it is also frequent in middle age men as a consequence of a big trauma during sport activities or working. this injury can be treated conservative of surgically, but regardless of the treatment, it always has a period of immobilization between 3 to 6 weeks. during the immobilization period, proximal structures suffer changes in mobility. shoulder's rom has to increased in order to compensate the immobilization of the wrist. previous studies shown that there is a relation between time of immobilization and shoulder pain. shoulder pain can significantly affect daily living activities as driving, dressing or even eating. also, pain does not appear only on it's own, but with other psychological factors as catastrophism, lower self-efficacy, fear of movement and avoidance. these factors could be crucial to predict disability in these patients, hence they should not be ignored during the rehabilitation process. our hypothesis is that the implementation of a proprioceptive shoulder exercise program during the period of immobilization may help and/or prevent shoulder pain secondary to immobilization.

Eligibility criteria:
inclusion criteria: * adult (equal or more than 18 y/o). * suffering a distal radius fracture and being in the first week of the immobilization period. * agree and sign informed consent. exclusion criteria: * not had suffered a distal radius fracture and/or not being on the immobilization period. * suffer any mental, cognitive, neurological or musculoskeletal disorder. * previous injury or pathology of the shoulder diagnosed as fractures, instability, shoulder pain or capsulitis. * previous shoulder surgery. * have cervical pathology/impairment.

Keywords: proprioceptive exercises function
recovery from psychosis in schizophrenia - the impact of cognitive-behavioral therapy

Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Summary: this study examines the impact of cognitive-behavior therapy (cbt) on symptoms, physiological arousal, stressors, and the ways to deal with them in individuals with schizophrenia and related disorders. the primary aim of this study is to investigate the role cognitive coping strategies play in mediating the link between stress, physiological arousal, and psychotic symptoms in individuals with schizophrenia during recovery from psychosis.

this study examines the mechanisms of recovery from psychosis. specifically, the study aims to evaluate the putative impact of enhancing cognitive coping strategies via cognitive-behavior therapy for psychosis (cbtp) on subjective stress, autonomic regulation (physiological arousal), and psychotic symptoms in individuals with schizophrenia and related disorders. as part of the study, participants will be randomized to receive up to 26 weekly sessions of cbtp (over 30 weeks) or "treatment as usual". research evaluations will completed at baseline, and after 10, 20 and 30 weeks. the study outcome measures include psychotic symptoms as measured by clinical interviews, along with ambulatory measures of autonomic regulation and self-reports of psychotic experiences during daily functioning using mobile devices (i.e., palm computers).

Eligibility criteria:
inclusion criteria: * males and females between ages 18-50. * have capacity to give informed consent. * english speaking. * have a dsm-iv diagnosis of schizophrenia, or schizoaffective disorder, or schizophreniform disorder. * presence of active psychosis as indexed by ratings ≥3 on any hallucinations and delusions items of the scale for assessment of positive symptoms (saps). exclusion criteria: * lacks capacity to give informed consent. * diagnosis of mental retardation (iq \< 80). * have history of neurological disorders or medical conditions known to seriously affect the brain. * have history of cardiac conditions or hypertension; current use of anti-cholinergic, beta-blockers, anti-histamine, or anti-hypertensive medication; abnormalities on ecg. * have used street drugs within the past 4 weeks.

Keywords: schizophrenia schizoaffective schizophreniform psychosis psychotic hallucinations delusions paranoia paranoid voices cbt cognitive behavior therapy cognitive therapy