Kornimate/medical-research-clean huggingface dataset:
study to evaluate the real-world effectiveness, safety and tolerability of treatment with apremilast in psoriatic arthritis patients followed in canadian routine care (appraise)

Conditions: Arthritis, Psoriatic

Summary: this will be a canadian observational study utilizing a prospective cohort design. patients with active psoriatic arthritis (psa) for whom the treating physician has decided, prior to and independently of enrollment in the study, to initiate treatment with otezla® will be considered for participation in the study. patients will be enrolled from the practices of predominantly community rheumatologists and will be followed for 12 months from the time of initiation of treatment with otezla® in line with the observational nature of the study, there will be no protocol imposed tests or assessments. however, recommended follow up visits will be at 4, 8 and 12 months. in addition, patients may be asked to voluntarily complete self-administered questionnaires. the 24-month assessment will be aimed to determine whether or not treatment with otezla® has been maintained, and if not, to ascertain the reason for discontinuation and what new treatment was initiated following discontinuation of otezla®


Eligibility criteria:
inclusion criteria: * active psoriatic arthritis (psa) as per the classification criteria for psoriatic arthritis (caspar) criteria, based on the investigator's clinical judgement. * adult patients (≥18 years of age) with psa * prescribing physician has decided to initiate treatment with otezla®, and this decision was prior to and independent of patient enrollment in the study. * access to commercially available otezla® exclusion criteria: * patients who are pregnant, breastfeeding, or who are planning on becoming pregnant during the course of the study * participation in investigational clinical trial within the last 60 days.

Keywords: psoriatic arthritis canada cc-10004 apremilast appraise safety non-interventional observation dmards
distinguishing between alzheimer's disease, lewy body dementia, and parkinson's disease

Conditions: Alzheimer's Disease; Lewy Body Dementia; Parkinson's Disease

Summary: the study is designed to characterize the clinical, neuropsychological, polysomnographic, and neuroimaging findings among subjects with alzheimer's disease, lewy body dementia, and parkinsons' disease.

the study will use structural and functional mris, datscans, fluorodeoxyglucose (fdg) pet scans, amyvid pet scans, polysomnographs, neuropsychological testing, cerebrospinal fluid in willing participants to distinguish between a diagnosis of alzheimer's disease, lewy body dementia, and parkinson's disease. all subjects will have a clinical evaluation, physical examination including vital signs and orthostatic blood pressures and pulses, neurological examination including updrs evaluation, genetic blood sample collection, neuropsychological testing, polysomnogram, and neuroimaging. the study partner will also be interviewed for completion of all of the behavioral and functional measures.

Eligibility criteria:
inclusion criteria: * subjects must meet the standard clinical criteria of the syndromes of interest * all subjects must have enough cognitive abilities to complete study procedures, which will be operationally defined as having a mini mental state examination (mmse) score greater or equal to 10. * subjects must be on stable cognitive and psychoactive medication regimen for the preceding four weeks of enrollment. * subjects must have a responsible study partner that either lives with them or is in regular contact with them at least 4 out of 7 days per week. * subjects must have visual and auditory acuity adequate for testing. exclusion criteria: * any other condition (other than the primary diagnosis), which in the opinion of the investigators might contribute to the syndrome of dementia or complicate its assessment. * active medical disorder that could preclude participation in this protocol * women who are pregnant or are breast feeding * severe renal impairment as defined by glomerular filtration rate (gfr) less than 30 (may have increased radiation exposure with the datscan). * subjects in whom english is not the 1st language * subjects with educational level less than 12 years * subjects who have ever participated in an experimental study with an amyloid targeting agent unless it can be documented that the subject received only placebo during the course of the trial.
dexanabinol in severe traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: each year a large number of patients are hospitalized at shock trauma centers with severe head injuries. bleeding into and swelling of these patients' brains may cause compression of vital structures, disability and death. sometimes surgery is needed. unfortunately, the investigators have no medication to treat the bad effects of head trauma. part of the brain damage is due to toxic chemicals (including one called glutamate) that are released by the damaged nerves. dexanabinol may prevent some of the bad effects of glutamate on the brain and may protect the brain against uncontrollable swelling and death.

dexanabinol is a synthetic, non-psychotropic cannabinoid derivative that because of its dextro-configuration is compatible with activation of cannabinoid receptors in the brain. it combines the ability to block nmda receptors and neuroinflammatory cascades in the same molecule. dexanabinol scavenges free radicals, protects neurons from toxicity of free radical generators and inhibits lipopolysaccharide-induced production of prostaglandin e2, no and tnf-a by macrophages in culture.

Eligibility criteria:
inclusion criteria: * traumatic head injury within the last 6 hours * glasgow coma motor score of 2 to 5; severity requires intracranial pressure (icp) monitoring * brain computed tomography (ct) showing intracranial parenchymal abnormality and hemodynamically stable * an informed consent exclusion criteria: * penetrating head injury * spinal cord injury * coma due to pure epidural hematoma with initial glasgow coma scale (gcs) of =\> 12 * previous major cerebral damage * concomitant severe conditions
surveillance cohort long-term toxicity antiretrovirals in hiv-infected patients enrolled in tpv cohort

Conditions: HIV Infections

Summary: the scolta project is a system for online surveying of adverse events to recently commercialized antiretroviral drugs and a sentinel for unexpected and late adverse events reactions arising during any antiretroviral treatment.aim of the proposed study is: 1. to evaluate the prevalence and incidence of serious adverse events and serious unexpected adverse events in hiv-infected patients enrolled in the scolta project tipranavir cohort and to identify possible risk factors 2. the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason.


Eligibility criteria:
inclusion criteria: * all patients \> 18 years old hiv infected treated with tipranavir exclusion criteria:
comparison of act between hemochron jr and act plus

Conditions: Cardiac Disease

Summary: this study aimed to compare 2 activated clotting time analysers (hemochron jr vs. act plus).

measurement of activated clotting time (act) is a standard method for anticoagulation monitoring. especially in cardiac surgery, heparin is usually used as anticoagulant and protamine is used to reverse anticoagulation effect at the end of surgery. act method defines the time until a clot is formed in a test tube after triggering of internal pathway coagulation using blood activating agents (eg. kaolin). acute normovolemic hemodilution (anh) consists of withdrawing patient's blood volume early in the operative period and concurrent infusion of crystalloid or colloid to maintain intravascular volume, and is used in cardiac surgery. anh is known to affect hemostasis in some studies. assuming that accurate monitoring of coagulation therapy is important to prevent both thrombotic and hemorrhagic complications, we compared act results from 2 analysers (hemochron jr and act plus) in patients undergoing cardiac surgery using anh.

Eligibility criteria:
inclusion criteria: * patients who underwent cardiac surgery with heparin administration. exclusion criteria: * preoperative hemoglobin under 11g/dl * weight under 40kg * preoperative coagulopathy

Keywords: whole blood coagulation time cardiac surgery
targeted motor learning to improve gait for individuals with parkinson disease

Conditions: Parkinson Disease

Summary: the purpose of this research study is to determine how training to step with a metronome on both a treadmill, as well as overground, will influence the way that people with parkinson disease walk. using metronomes is commonly used in clinics, but the investigators will be using a combination of slow and fast frequencies to alter the way that people walk. the use of a slower frequency metronome on the treadmill is intended to help participants take larger steps. the use of a faster frequency metronome while walking overground is intended to help participants take faster steps.this will take place over 12 training sessions. each session will be about an hour. it will include some walking tests and pictures of the brain (using mri) before and after training.

some details regarding the metronome frequency are purposely omitted at this time to preserve scientific integrity. they will be included after the trial is complete

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease (hoehn and yahr stage 2-3) * self-report the ability to walk uninterrupted for 10 minutes both overground and on a treadmill without therapist assistance * comfortable gait speed \> 0.4 m/s and \< 1.2 m/s * normal (or corrected to normal \[i.e., hearing aid\]) hearing * deficits in gait continuity (e.g., shuffling, shortened strides, freezing, festination, bradykinesia, etc) based on observational gait analysis * movement disorders society - unified parkinson disease rating scale (mds-updrs-iii) item 10 ≥1 and \<3 * be on stable doses of orally-administered levodopa * age 50-80 years old exclusion criteria: * contraindications to mri (e.g., metal implants, claustrophobia, etc) * cognitive deficits (montreal cognitive assessment \[moca\] \< 26) * concurrent physical therapy * have undergone deep brain stimulation surgery * cannot walk without therapist assistance * uncontrolled cardiorespiratory/metabolic disease, or other neurological disorders or orthopedic injury that may affect gait.

Keywords: gait rehabilitation
effects of cognitive versus task oriented training on balance, gait and daily activity in chronic stroke patients

Conditions: Stroke, Ischemic; Cognitive Impairment; Balance; Distorted; ADL

Summary: to determine effects of cognitive sensorimotor exercises versus task oriented training on balance, gait and activities of daily living in chronic stroke patients.

this study will be randomized clinical trial with total of 40 participants with chronic stroke. patients will be recruited from riphah rehabilitation centre and national hospital lahore. the sampling technique will be non probability convenience sampling technique. the patients will be randomized by lottery method and allocated into two intervention groups. patients in group a will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks. patients in group b will receive task-oriented training for 30 minutes, sessions for 5 days per week for 8 weeks. intervention will be applied for 8 weeks it includes taking reading 1st at baseline, 2nd reading at 4th week and 3rd reading at 8th week and follow up after 12 weeks. the assessment tools used will be berg balance test for balance, dynamic gait index for gait and modified barthel index to assess activities of daily livings. data will be analysed by using spss 25 version.

Eligibility criteria:
inclusion criteria: * patients diagnosed with chronic stroke (6 months to 2 years) * patients with the ability to walk independently using aids or orthotics with or without supervision. * ability to communicate and follow instructions. * no problem walking due to ankle contracture. * no sensory deficiencies of the lower extremities. * patients cognition level on mmse ≥ 24 exclusion criteria: * recent injuries- patients having musculoskeletal or surgical problems of lower extremity. * co-morbid conditions- cardiovascular (uncontrolled high blood pressure, diabetes), respiratory problems like dyspnoea. * neurological conditions- like brain tumour, demyelinating disease, parkinson's disease, multiple sclerosis). * subjects with auditory and vestibular disorders. * cerebellar related problems.

Keywords: stroke, ischemic cognitive impairment balance; distorted adl
effect of intranasal administration of orexine a on il-6-system, sleep-wake-regulation and neurocognition

Conditions: Narcolepsy

Summary: 15 patients with narcolepsy and 15 healthy controls will be included in the study. according to a randomized, double-blind protocol they will receive intranasally at night first orexine a and approximately two weeks later placebo or vice versa. thereafter sleep will be recorded, the cytokine-system and neurocognition characterized.


Eligibility criteria:
inclusion criteria: * narcolepsy * age \>18 * informed consent * german fluently spoken exclusion criteria: * additional severe psychiatric or somatic disorders * pregnancy or nursing * anemia (hb\<10g/dl)

Keywords: narcolepsy orexines sleep cognition cytokines
the effect of a muscle-mimicking, fabric-type shoulder orthosis on functional movements of the upper limb in patients with duchenne muscular dystrophy

Conditions: Muscular Dystrophy, Duchenne; Orthotic Devices; Upper Extremity

Summary: the goal of this clinical trial is to investigate the effect of a muscle-mimicking, fabric-type shoulder orthosis on functional movements of the upper limb in patients with duchenne muscular dystrophy. the main questions it aims to answer are: * what is the impact of the muscle-mimicking, fabric-type shoulder orthosis on upper limb functional movements in patients with duchenne muscular dystrophy? * are there observable differences in upper limb function when the shoulder orthosis is worn versus when it is not? participants will: * receive education on how to wear and use the shoulder orthosis. * undergo evaluations, including assessment of upper limb performance, shoulder muscle strength testing, active range of motion measurements, assessment of functional workspace, goal attainment scale evaluation, surface electromyography, physiological measurements such as blood pressure and heart rate, fatigue assessment, and assessment for any musculoskeletal or skin-related issues. researchers will compare duchenne muscular dystrophy patients before and while wearing and operating the shoulder orthosis to see if there are any significant effects on variables such as upper limb function, range of motion, functional workspace, goal attainment scale, and surface electromyography.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of duchenne muscular dystrophy (dmd) through genetic testing * older than 10 years old * brooke scale score of 2-5 * shoulder abduction muscle strength grade below 3 exclusion criteria: * unable or unwilling to provide informed consent * brooke scale score of 1 or 6 * cognitive impairment to the extent that limits the use of the shoulder orthosis
a study of ibandronate [bonviva/boniva] and alendronate in female patients with post-menopausal osteoporosis

Conditions: Postmenopausal Osteoporosis

Summary: this observational study will assess the compliance and persistence of patients, real life efficacy and safety of intravenously quarterly administered 3 mg ibandronate \[bonviva/boniva\] in comparison to oral alendronate generics in female patients with post-menopausal osteoporosis. the anticipated time of assessment is 12 months. the target sample size is 5000-7000 patients.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 55 years of age * postmenopausal osteoporosis * patients who are in the opinion of the physician eligible to participate in this study exclusion criteria: * n/a
glucose-dependent insulinotropic polypeptide - effects on markers of bone turnover in patients with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: investigate gip effects on biomarkers involved in bone homeostasis


Eligibility criteria:
inclusion criteria: * patients with type 1 diabetes (positive islet cell/ glutamic acid decarboxylase-65 antibodies) * patients without measurable beta cell function (i.e. incremental c-peptide below detection limit (\<0.16 nmol/l) following an 5 g-iv-arginine stimulation test, exclusion criteria: * hba1c \>9% (75 mmol/mol), * standard plasma biochemical measurements outside normal reference interval (alanine aminotransferase, bilirubin, thyroid-stimulating hormone, hemoglobin, creatinine, and spot urine albumin-creatinine ratio); * an abnormal state of hypoglycemia awareness, * significant diabetic complications (i.e. proliferative diabetic retinopathy, neuropathy, severe atherosclerosis, heart disease) and, * treatment with medication (besides insulin) that could not be paused for 12 hours up to and during the days of the experiments.
expanded access for ag-221

Conditions: Acute Myeloid Leukemia

Summary: this is an expanded access program (eap) for eligible participants designed to provide access to ag-221.


Eligibility criteria:
inclusion criteria: - exclusion criteria: -

Keywords: expanded access compassionate use
pectoral nerve block ii and erector spine plane block in breast cancer surgery

Conditions: Anesthesia; Analgesia; Acute Pain; Chronic Pain; Pectoralis Nerve Block; Erector Spine Plane Block; Patient Controlled Analgesia

Summary: this study evaluates the analgesic effects of pectoralis nerve block (pecs ii) and erector spinae plane block (esp) in patients having segmental mastectomy and sentinel lymph node biopsy (slnb). each one-third of patients will have esp block and pectoralis nerve block (pecs ii) 30 min before general anesthesia , while other one-third of patients will have only general anesthesia.

it has been proven that pecs ii and esp both supply effective analgesia in the first 24 hours after mastectomy. but they do so by different mechanishms. this study is to survey that esp and pecs ii may supply acute and chronic analgesia by reducing pain scores in the first 24 hours and 3 months after the surgery, also the comparison of the analgesic activity among themselves for acute / chronic pain and opioid consumption will be searched. in this study patients are divided into three groups. patients in pecs group will have pecs ii block in a separate section from the operating rooms (pnb practice room). in addition, patient controlled analgesia (pca) will be used in the first 24 hours postoperatively. patients in esp group will have esp block in a separate section from the operating rooms (pnb practice room). in addition, pca will be used in the first 24 hours postoperatively. patients in control group will not be performed nerve block. only general anesthesia (ga) will be performed in the operation room. in addition, pca will be used in the first 24 hours postoperatively.

Eligibility criteria:
inclusion criteria: * asa 1-2 patients between the age of 18-65, scheduled for elective unilateral segmental mastectomy + sentinel lymph node biopsy exclusion criteria: * age \ 65, asa 3-4 patients * obesity (\> 100 kg, bmi\> 35 kg / m2) * patients undergoing bilateral mastectomy * pregnancy * contraindication of regional anesthesia (coagulopathy, abnormal inr, thrombocytopenia, infection at the injection site) * serious renal, cardiac, hepatic disease * hypersensitivity to local anesthetics or a history of allergy * patients with a history of opioid use longer than four weeks * patients with psychiatric disorders or communication difficulties * patients with chest deformity * patients with previous breast surgery except diagnostic biopsies * patients who do not want to participate

Keywords: regional anesthesia acute and chronical pain pectoralis nerve block erector spine plane block
a randomised controlled trial of a weight loss maintenance program for adults with obesity: the wlm3p study

Conditions: Obesity

Summary: the aim of this study is to evaluate the effectiveness of a weight loss maintenance 3 phases program (wlm3p) in maintaining long-term weight loss (at least 5% of initial body weight loss at 18 months), compared to a standard low carbohydrate diet (lcd) in adults with obesity.


Eligibility criteria:
inclusion criteria: * men and women aged 18 to 65 years * bmi ≥ 30 kg/m2 and ≤ 39.9 kg/m2 * interested in being enrolled in a weight loss program * available to comply with study protocol and sign informed consent exclusion criteria: * pregnant, breastfeeding or planning to become pregnant within the study period. * subjects with chronic inflammatory bowel disease (clinical history of crohn's disease, ulcerative colitis, irritable colon and diverticulitis) * subjects with hormonal or thyroid pathology (hyper and hypothyroidism where tsh is not within normal range) * subjects with renal impairment * subjects with chronic liver disease other than non-alcoholic hepatic steatosis * subjects with autoimmune diseases and/or chronic use of corticosteroids. * use of weight loss medications/other nutritional supplements * subjects with psychiatric or neurological illness * subjects sensitive to any component of supplements * subjects with surgery or hospitalization in the last 30 days * subjects prescribed with 5 or more drugs * previous attempt to lose weight in the last month and/or weight loss of more than 10kg in the 3 months prior to the start of the study * subjects with excessive alcohol consumption (self-reported: drinking more than 3 glasses of wine/day - or equivalent) * subjects with history of drug, alcohol or other substances abuse. * eating behavior disorders * pacemaker carrier * urinary incontinence * vegetarians or vegans * subjects underwent bariatric surgery * type 1 or type 2 diabetes mellitus * altered blood clotting * severe heart failure