Kornimate/medical-research-clean huggingface dataset:
lumbar stabilization exercises vs flexor exercises in degenerative spondylolisthesis

Conditions: Degenerative Spondylolisthesis; Chronic Low Back Pain

Summary: the purpose of this study is to compare the effectiveness of pain control and functional improvement in patients with degenerative spondylolisthesis treated with "lumbar stabilization exercises" vs "flexor exercises (williams exercises)"

this study is a randomized controlled trial in patients with the diagnosis of degenerative spondylolisthesis. to date, it is known that lumbar stabilization exercises are an effective treatment option in controlling pain and improving function in patients with degenerative spondylolisthesis based on previous studies, but it is not known if is this a better treatment that another exercises routine for chronic lbp (low back pain). the purpose is to compare the effectiveness on pain control and functional improvement of "lumbar stabilization exercises" vs "flexor exercises (williams exercises)". all clinical evaluations are performed by a single physician who is blinded to the exercises, and include a full medical history, physical examination, and x-ray measurement. after initial evaluation, patients are given a sealed envelope containing the treatment (by simple randomization assigned by the investigator). the envelope is opened by the physical therapist which schedules a monthly session and verify the correct execution of each exercise. each patient receives a sheet with instructions of the exercises to continue daily at home. scales to assess pain and function will be recorded at baseline, 4 weeks, 3 months and at 6 months to complete the follow up.

Eligibility criteria:
inclusion criteria: * degenerative spondylolisthesis at l4-l5 and chronic lbp with or without radicular pain * attending the spinal rehabilitation service of the national institute for rehabilitation (mexico city). * without previous treatment * agree to participate through informed consent. exclusion criteria: * history of lumbar surgery, * rheumatic diseases: rheumatoid arthritis, lupus erythematosus systemic, fibromyalgia, etc. * cauda equine symptoms, * ischemic heart disease * diabetic polyneuropathy * illiterate

Keywords: spondylolisthesis low back pain stabilization exercise
ischemic pain control with analgesic methods clinical trial

Conditions: Arterial Occlusive Diseases

Summary: this project is one of four components of a thematic project that aims to evaluate the use of ultrasound in regional blocks, called "use of ultrasound in regional blocks and injections for the treatment of acute and chronic pain." it will evaluate quantitative and qualitative control of ischemic pain in the lower limbs in patients with peripheral arterial occlusive disease through continuous sciatic nerve block by perineural catheter, popliteal approach, compared to systemic analgesia based on opioids.

background: peripheral arterial occlusive disease (paod) commonly evolves with intense ischemic pain in the lower limbs, which is hard to control with systemic analgesics, and continuous regional anesthesia may be an alternative, with adequate analgesia and lower incidence of side effects. objectives: evaluate qualitative and quantitative pain control, incidence of adverse effects and operative results in patients with paod undergoing continuous anesthetic blockade of the sciatic nerve by perineural catheter compared to systemic analgesia based on opioids and adjuvant medications. methods: it is a randomized clinical trial, covered for evaluators. it will include 56 patients with paod fontaine iv, with pain by the presence of ulcerations located on foot. a group will be submitted to continuous regional anesthesia of sciatic nerve through perineural catheter and another group will have its pain control through patient controlled analgesia device with intravenous fentanyl. the primary dependent variable will be pain, through the numerical pain scale.

Eligibility criteria:
inclusion criteria: * patients older than 18 years old who have strong or moderate persistent ischemic pain in the lower limbs, due to peripheral artery occlusive disease, classified as fontaine iv (pain at rest and presence of ulcer or gangrene). exclusion criteria: * uncooperative patients, coagulation disorders, patients with liver failure, who have atrioventricular block second or third degree, who refuse to be submitted to peripheral nerve block, with systemic or procedure site local infection infection, peripheral or central neuropathy history, allergies to local anesthetics or to any of the drugs to be used in the study and difficulty in understanding the use of the pca (patient-controlled analgesia) device and evaluation methods used in the study .
glaucoma screening

Conditions: Glaucoma

Summary: * the primary objective of this study is to evaluate the diagnostic accuracy of the tempo (imovifa) visual field perimeter screening test by measuring the sensitivity in a population of eyes with glaucoma and the specificity in a population of normal eyes and to measure repeatability of the screening test. * the secondary objective of this study is to gather and analyze ancillary data to confirm the diagnosis or absence of glaucoma.


Eligibility criteria:
inclusion criteria (all subjects): * subjects 40 years of age or older on the date of informed consent. * subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent. * bcva 20/40 or better in both eyes. inclusion criteria- normal population * iop ≤ 21 mmhg * healthy anterior and posterior segment evaluation on clinical examination. inclusion criteria - pathology population • diagnosis of glaucoma on clinical examination. exclusion criteria (all subjects): * unable to tolerate ophthalmic imaging and/or diagnostic testing. * history of intraocular surgery (uncomplicated surgeries are accepted). * ocular diseases including uveitis, non-glaucomatous optic neuropathy, severe or proliferative diabetic/ hypertensive retinopathy (controlled diabetes and hypertension participants with no or mild to moderate retinopathy \[not involving the macula\] can be included), unresolved trauma. * any neurodegenerative diseases including alzheimer, parkinson, or dementia, or history of stroke. * unreliable vf testing and/or poor-quality oct scans. * poor fixation.
safety study for nst-001 and the neuroject injection set to treat tinnitus

Conditions: Tinnitus

Summary: this research study involves an experimental drug (nst_001) and a delivery system. the main purpose of this research study is to investigate the safety of nst-001, delivered directly to the inner ear for the treatment of tinnitus.


Eligibility criteria:
inclusion criteria: * patients able to provide voluntary consent. * severe tinnitus in one ear that began no more than ten years ago. * ear to be treated must be deaf or have profound hearing loss. * subjects with cardiac disease or hypertension, must have stable disease for at least 6 months. * subject must have intact cochlear nerve on the ear to be treated. * women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods as recommended by the study physician. exclusion criteria: * current diagnosis of bilateral tinnitus. * current diagnosis or history of pancreatitis. * females that are pregnant or lactating. * use of investigational drugs within the previous 30 days. * history of drug dependency or other substance abuse.

Keywords: tinnitus acouphenes ear ringing buzzing roaring hissing clicking
benefits of endoscopic bariatric procedures

Conditions: Obesity

Summary: this 12-months long pilot study will include patients undergoing an endoscopic procedure (endoscopic sleeve gastroplasty \[esg\] or transoral outlet reduction \[tore\]) as clinically indicated, and subsequent follow up clinic visits for up to one year.

the purpose the research is to better understand the effects of endoscopic bariatric therapy (ebt) on the weight change, hormonal changes and changes in the quality of life parameters for patients undergoing endoscopic bariatric procedures. the primary research procedures are: * ebt procedure (endoscopic sleeve gastroplasty \[esg\] or transoral outlet reduction \[tore\]) * behavioral intervention consisting of diet therapy, exercise therapy, and behavior modification * collection of blood to evaluate changes in hormonal profiles

Eligibility criteria:
inclusion criteria: * patients who are considering undergoing ebt for weight loss * patients with a bmi \>30 kg/m2 (without obesity related comorbidities) * patients with a bmi \>27 kg/m2 (with obesity related comorbidities) * patients willing and able to comply with study requirements for follow-up * patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight * individuals 18 years old or older are included exclusion criteria: * pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline esophagogastroduodenoscopy (egd) * esophageal, gastric or duodenal malignancy * severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist * uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (asa, plavix) for 1 week prior to and 2 weeks after each endoscopy * known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices * general poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation at the discretion of the investigator * pregnant or planning to become pregnant during period of study participation * patient refuses or is unable to provide written informed consent * prior surgical or endoscopic anti-reflux procedure * patients who are unwilling or unable to comply with the follow-up study schedule
employment-based depot naltrexone clinical trial

Conditions: Opiate Dependence

Summary: the purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.

a randomized study is planned over 5 years to evaluate the effectiveness of the therapeutic workplace in promoting naltrexone adherence in opiate-dependent adults. an extended-release depot formulation of naltrexone will be used. participants will be offered an inpatient opioid detoxification and naltrexone induction. participants who complete the oral naltrexone induction will be randomly assigned to one of two groups. both groups will be invited to work in the therapeutic workplace and will be prescribed depot naltrexone for 6 months. patients in the "work plus naltrexone contingency" condition will earn access to working and earning salary by taking depot naltrexone once per month. "work plus naltrexone prescription" participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so.

Eligibility criteria:
individuals were eligible if they: * met the diagnostic and statistical manual of mental disorders, 4th. edition (dsm-iv) criteria for opioid dependence, * reported using heroin on at least 21 of the last 30 days while in community, * were unemployed, * were aged 18-65 years, * were medically approved for naltrexone * lived in or near baltimore, md. individuals were excluded if they * had current dsm-iv major axis i disorders, * had current suicidal or homicidal ideation, * expressed interest in methadone treatment, * were required to use opioids for medical purposes, * earned more than $200 in taxable income over the previous 30 days, * had physical limitations that would prevent them from using a keyboard, * were pregnant or breastfeeding, * had serum aminotransferase levels more than three times over normal.

Keywords: opiate dependence naltrexone reinforcement behavior therapy cocaine dependence risk reduction behavior
a study of nivolumab alone or nivolumab combination therapy in colon cancer that has come back or has spread

Conditions: Microsatellite Unstable Colorectal Cancer; Microsatellite Stable Colorectal Cancer; Mismatch Repair Proficient Colorectal Cancer; Mismatch Repair Deficient Colorectal Cancer

Summary: the purpose of this study is to examine if nivolumab by itself, or nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in participants with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 to 1 * histologically confirmed recurrent or metastatic colorectal cancer * measurable disease per recist v1.1 * microsatellite instability expression detected by an accredited laboratory * participants enrolled into the c3 cohort must have not had treatment for their metastatic disease exclusion criteria: * active brain metastases or leptomeningeal metastases are not allowed * prior treatment with an anti-programmed death receptor (pd)-1, anti-pd-l1, anti-pd-l2, anti-cytotoxic t-cell lymphoma-4 antigen (ctla-4) antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or immune checkpoint pathways * prior malignancy active within the previous 3 years except for locally curable cancers * participants with active, known or suspected autoimmune disease * participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration other protocol-defined inclusion/exclusion criteria apply
cognitive changes in alzheimer's disease patients associated with or without white matter changes after rivastigmine

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate and compare the changes of cognitive function (as measured by adas-cog) in the two group of patients with alzheimer's disease (ad) associated with and without white matter changes after rivastigmine patch therapy.

acetylcholinesterase inhibitors (acheis) increase the amount acetylcholine at ach receptors within the brain, and are the primary medications used to treat ad. alzheimer's disease patients are frequently associated with mild or moderate white matter changes on mr imaging. the impact of whiter matter changes on the efficacy of cognition, functional abilities, behavioral and psychiatric symptoms and caregiver burden for probable alzheimer's disease is not well known. there are very few studies for the efficacy of rivastigmine between the patients with mild to moderate alzheimer's disease associated with or without vascular risk factors. recently, the rivastigmine patch demonstrated efficacy comparable to the highest doses of rivastigmine capsules, with markedly improved tolerability profile. the investigators hypothesized that rivastigmine patch will provide benefits to ad patients with white matter changes compared to those without any white matter changes. possible explanation about favorable benefits for ad with white matter changes is that rivastigmine may act on both alzheimer's and vascular pathologies contributing to dementia, providing additive treatment effects in patients suffering from both conditions concurrently. to our knowledge, there was no study or clinical trial to compare the changes of cognitive function, adl, bpsd and caregiver burden in two groups of patient with alzheimer's disease associated with or without white matter changes after rivastigmine transdermal patch therapy.

Eligibility criteria:
inclusion criteria: * ad in nincds-adrda criteria, mild to moderate * probable ad with or without mild to moderate whiter matter lesions, excluding multiple large vessel infarcts or a single, strategically placed infarct (angular gyrus, thalamus, basal forebrain, territory of the posterior or anterior cerebral artery) on mri scan (within 12 months) * mmse score : 10 to 26 at screening * hachinski scores ≤ 4 * no clinically significant laboratory abnormalities, such as thyroid disease, vitamine b12 deficiency or folic acid deficiency exclusion criteria: * current evidence of history of neurological, psychiatric and other illness that could contribute to dementia * subjects with clinical significant cardiovascular disease, stroke, pulmonary disease or any other medical disease in the past 6 months * history of cancer within the last 5 years * subjects with evidence or history of clinically significant allergic reaction to achei or drugs * subjects who had significant visual or hearing difficulties

Keywords: alzheimer's disease rivastigmine patch white matter change
automated, assistive, non-contact sleep quality monitor for individuals with alzheimer's disease

Conditions: Alzheimer Disease; Dementia; Sleep Disturbance

Summary: this study seeks to evaluate the utility and efficacy of the non-contact sleep quality monitor system when used to monitor the sleep quality of individuals living in long-term care (ltc) with either alzheimer's disease (ad) or alzheimer's disease related dementia (adrd). this before-after comparison trial will be conducted in several ltc facilities to evaluate the effect access to system sleep quality data has on documentation of sleep disorders or treatments and sleep quality change over time for ad/adrd participants in the intervention group as compared to the control group. all subjects will undergo sleep quality monitoring for 4-weeks. at the end of the first 2-weeks, research staff and ltc facility staff and medical providers will receive access to sleep monitoring data. we hypothesize that when real-time system sleep data is shared with ltc staff or healthcare providers, that sleep disturbances will be more readily detected, leading to timelier, better tailored treatment interventions for sleep disturbances, thereby improving sleep quality and decreasing daytime physical inactivity.

the purpose of this study is to evaluate the utility of a non-contact sleep quality monitor system and determine the effect that sharing system sleep data with long-term care (ltc) staff and healthcare providers has on documentation and treatment of sleep disorders and change in ad/adrd participant sleep quality. system sleep data will be collected for a total of 4-weeks. during the intervention condition system sleep data will be shared for 2-weeks, while in the initial control condition no system sleep data will be shared for 2-weeks. healthcare providers can prescribe a non-pharmacologic sleep protocol and/or if they so choose, pharmacotherapy to manage sleep disturbances for subjects in either the intervention or control condition, in accordance with standard medical practice. the investigators hypothesize that when real-time system sleep data is shared with ltc staff or healthcare providers, that sleep disturbances will be more readily detected, leading to timelier, better tailored treatment interventions for sleep disturbances, thereby improving sleep quality and decreasing daytime physical inactivity.

Eligibility criteria:
inclusion criteria: * diagnosis of alzheimer's disease (ad) or alzheimer's disease related dementias (adrd) * residents of long-term care (ltc) facility study site location for a minimum of 30 days. * willingness to consent to study or when a potential participant lacks decision making capacity (determined by ltc facility clinical provider) willingness of a legally authorized representative (lar) to consent to study participation on potential participant's behalf. exclusion criteria: * currently on hospice

Keywords: sleep assessment sleep disorder technology dementia long-term care sleep monitoring
cognitive training in obsessive compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: this unique study will allow us to observe the neural correlates associated with working memory in an obsessive compulsive disorder (ocd) paradigm. we believe that developing working memory in participants suffering with ocd will reduce the severity of their symptomology. this will allow a greater understanding into the functioning of these participants which in turn presents with treatment possibilities.

it is currently unclear whether cognitive training using a working memory task, is effective in reducing obsessive-compulsive symptoms and neuropsychological deficits in patients with ocd. two groups (ocd and control) will be recruited. both groups will undergo an intervention consisting of 8 weeks of cognitive training. working memory, neuropsychological functioning and ocd symptomatology will be assessed pre and post-treatment, in both groups. furthermore neuroimaging using functional magnetic resonance imaging (fmri) will be conducted at baseline as well as at the end of the 8 week period in both groups. the scan will serve to show any structural or functional changes in the frontostriatal area involved with working memory. to our knowledge, this is one of the first studies to date to examine whether cognitive training improves symptoms in ocd.

Eligibility criteria:
inclusion criteria: * a primary diagnosis of ocd, with a score \> 16 on the yale-brown obsessive compulsive scale (ybocs) (goodman et al, 1989b, 1006-1011). * participants must be aged older than 18 and younger than 65 years. * right handed. * if taking ssri's the participant needs to be on a stable dose for at least 2 months. exclusion criteria: * significant physical or neurological illnesses. an exception will be made for patients taking ssri's (and not using any other drugs). * any significant current dsm disorder (in addition to ocd). * past history of significant substance or alcohol abuse. * pregnancy. * any metal pins/ prostheses or cardiac pacemakers. * sufferers of claustrophobia. * head injury
xarelto for prevention of stroke in patients with atrial fibrillation in asia

Conditions: Atrial Fibrillation

Summary: this is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.


Eligibility criteria:
inclusion criteria: * female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-cns (central nervous system) systemic embolism, and who consent to participate in the study.

Keywords: stroke embolism atrial fibrillation
a research study, looking at how tresiba® works in people with type 2 diabetes in local clinical practice in russia

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to collect information on how tresiba® works in real world patients with diabetes mellitus, type 2 (type 2 diabetes). participants will get tresiba® as prescribed by their doctor. the study will last for around 6 to 8 months. participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). * the decision to initiate treatment with commercially available tresiba® has been made by the patient and the treating physician before and independently from the decision to include the patient in this study. * male or female, age above or equal to 18 years at the time of signing informed consent. * diagnosed with type 2 diabetes and treated with any antihyperglycemic medication(s), except tresiba® (insulin degludec), for at least 26 weeks prior to informed consent and initiation visit (visit 1). * available and documented hba1c value 12 weeks or less prior to initiation of tresiba® treatment. exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * hypersensitivity to the active substance or to any of the excipients as specified in the tresiba® local label