Kornimate/medical-research-clean huggingface dataset:
comparative evaluation of different file systems in postoperative pain

Conditions: Pulpitis; Periapical Periodontitis; Necrotic Pulp

Summary: postoperative pain is a frequent complication associated with root canal treatment. the apical extrusion of irrigant and debris, including bacteria and necrotic tissue, may lead to postoperative pain, periapical inflammation, and flare-ups. the instrumentation technique and the file design may affect the amount of debris extrusion. the aim of this study was to evaluate the influence of instrumentation techniques on the incidence and intensity of postoperative pain after single-visit root canal treatment.

sixty patients having root canal treatment indication and a single root canal were included in the study. the patients were randomly assigned into 2 groups according to root canal instrumentation technique used. in group 1; protaper next (dentsply maillefer, ballaigues, switzerland) instruments with rotational motion, in group 2 tf adaptive (sybronendo, orange, ca) instruments with adaptive motion were used for root canal treatments. root canal treatment was carried out in a single visit and the severity of postoperative pain was assessed via a four-point pain intensity scale. all the participants were called through the phone at 12, 24 and 48h to obtain the pain scores. data were analyzed using the mann whitney-u, friedman and wilcoxon tests.

Eligibility criteria:
inclusion criteria: * having root canal treatment indication * single root canal exclusion criteria: * previously treated tooth
evaluation of glistenings in intraocular lenses implanted in normal patients following routine cataract extraction.

Conditions: Glistenings

Summary: evaluation of glistenings in intraocular lenses implanted in normal patients following routine cataract surgery. the lenses used will be model x-60 made by the avs company vs acrysof ma50bm made by the alcon company.


Eligibility criteria:
inclusion criteria: * 18 years or older * bilateral cataracts requiring surgery * potential visual acuity of 20/40 or better in both eyes * require iol power in range of 15-25 diopters * pupillary dilation of at least 6mm * willing and able to provide informed consent and attend follow-up appointments to 3 years exclusion criteria: * any co-existing ocular disease or previous ocular surgery that would confound findings in the study, especially those effecting quality of vision. examples include macular degeneration amblyopia and prior epiretinal membrane peel.

Keywords: cataracts,glistenings,intraocular lenses.
investigating the effectiveness of a seasonal influenza vaccination promotion campaign for members of a non-profit, community-based health insurance plan: 2018-2019

Conditions: Influenza, Vaccination

Summary: • this study will assess the effect of promotional messaging and incentives encouraging influenza vaccination in the sendero idealcare policy holders during the 2018-2019 flu season. the intervention will consist of influenza vaccination promotion/reminders from sendero health plans to subscribers, including text messages, emails, and tailored direct mail outs, i.e. postcard or a personalized letter, and incentive. the study population consists of approximately 22,500 subscribers enrolled in sendero idealcare plan. the intervention will last approximately four months. the primary endpoints, assessed through administrative claims data, will be getting a flu shot during the 2018-2019 season. data collected through this study will be used to determine effective components of influenza vaccination promotion campaigns used by a health insurance plan.


Eligibility criteria:
inclusion criteria: * enrollment in sendero idealcare health plan as of august 1, 2018 * age 18 years or older exclusion criteria: * a coverage termination date listed prior to december 31, 2018. * sendero member records lack both a phone number and email address.
predictive value of risk scores in acute coronary syndrome

Conditions: Acute Coronary Syndrome; Left Ventricle Remodeling; Risk Scores

Summary: role of different risk scores in acute coronary syndrome to predict left ventricular remodeling

patients with acute coronary syndrome (stemi, nstemi, ua) will be included and different risk scores will be calculated for each patient. after that in-hospital and short-term outcome beside left ventricular systolic and diastolic functions (at admission and 3m later) will be assessed to be correlated with different risk scores to determine which score system was able to predict left ventricular remodeling and what was the cut off value, sensitivity, and specificity of the score

Eligibility criteria:
inclusion criteria: * patients with acute coronary syndrome exclusion criteria: * previous acute coronary syndrome previous pci or cabg chronic renal disease decompensated liver disease patient refusal to participate patients dropped during follow up

Keywords: risk score acute coronary syndrome left ventricular remodelng
the effect of resistance to participant-supported reaching on workspace of the hand in severe chronic stroke

Conditions: Stroke

Summary: disturbances in movement coordination are the least well understood but often the most debilitating with respect to functional recovery following stroke. these deficits in coordination are expressed in the form of abnormal muscle synergies and result in limited and stereotypic movement patterns that are functionally disabling. the result of these constraints in muscle synergies is an abnormal coupling between shoulder abduction and elbow flexion (i.e. the flexion synergy), which significantly reduces the reaching function of an individual with stroke when they lift up the weight of the impaired arm against gravity. the investigators previous neurotherapeutic research, supported by a nidrr field initiated research grant, has shown that the abnormal synergy between shoulder abduction and elbow flexion can be significantly reduced thus increasing total reaching range of motion in individuals with severe stroke. the previous work established progressive abduction loading as a key element to the rehabilitation of reaching. although individuals with severe stroke benefited from the investigators previous work, residual flexion synergy continued to hinder normal arm function in most participants with severe stroke. this study will utilize the act3d robot, developed as part of the investigators previous nidrr project, to incorporate resistance to reaching while accounting for the known benefits of progressive abduction loading. the investigators propose to randomize forty participants with severe stroke into two closely related interventions. the groups will both practice reaching under abduction loading, however, the experimental group will also move against resistance while reaching. rigorous and quantitative investigation of therapeutic elements such as resistance to reaching and progressive abduction loading is only possible with a device such as the act3d. the investigators will be able to standardize the delivery of each intervention using kinematic and kinetic parameters, which will allow for a clear identification of the therapeutic effect of resistance to reaching. the investigators hypothesize that resistance to reaching in combination with progressive abduction loading will further increase dynamic multi-joint strength, increase total reaching range of motion, and increase arm function thus enhancing actual amount of use of the arm, participation in life roles, and quality of life in individuals with severe stroke.


Eligibility criteria:
inclusion criteria: * paresis confined to one side, with substantial motor impairment of the upper limb * absence of motor impairment in the unimpaired limb * absence of severe concurrent medical problems (e.g. cardiorespiratory impairment, changes in management of hypertension) * absence of any acute or chronic painful condition in the upper extremities or spine * absence of hemineglect * capacity to provide informed consent.

Keywords: arm strength coordination physical therapy robotics stroke synergy
a study of the safety and performance of the minitac◊ titanium 2.0 suture anchor

Conditions: Hallux Valgus Repairs; Medial or Lateral Instability Repairs/Reconstructions; Achilles Tendon Repairs/Reconstructions; Midfoot Reconstructions; Metatarsal Ligament/Tendon Repairs/Reconstructions; Scapholunate Ligament Reconstructions; Ulnar or Radial Collateral Ligament Reconstructions; Lateral Epicondylitis Repair; Biceps Tendon Reattachment

Summary: this is a retrospective study evaluating the safety and performance of the minitac suture anchors for extremities repair. data will be used to support notified body (bsi) requirements for extremities repair indications.

up to 3 sites will participate in the study across australia and the eu, collectively enrolling a minimum of 30 and a maximum of 50 subjects into the study.

Eligibility criteria:
inclusion criteria: 1. subject has undergone extremities repair using the minitac◊ ti 2.0 suture anchor. 2. subject was ≥ 18 years of age at time of surgery. 3. subject status is \> 12 months post-operative. exclusion criteria: subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
empagliflozin (bi 10773) comprehensive add-on study in japanese subjects with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of the study is to investigate the long-term safety and efficacy of bi 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.


Eligibility criteria:
inclusion criteria: * .diagnosis of type 2 diabetes mellitus prior to informed consent * male and female patients, on diet and exercise regimen, who are pre-treated with one of the following oral antidiabetic drugs: sulfonylurea, glinide, biguanide, alpha-glucosidase inhibitor (a-gi), dipeptidyl peptidase-iv (dpp-iv) inhibitor or thiazolidinedione * glycosylated haemoglobin (hba1c) at visit 1: \>=7.0 to =\<10.0% (national glycohemoglobin standardization program) exclusion criteria: * uncontrolled hyperglycaemia with a glucose level \>240 mg/dl (\>13.3 mmol/l) * acute coronary syndrome, stroke or transient ischemic attack (tia) within 12 weeks prior to informed consent * indication of liver disease, defined by serum levels of either alanine transaminase (alt), aspartate transaminase (ast), or alkaline phosphatase (alp) above 3 x upper limit of normal (uln)
effect of early systemic stabilization therapy on recent onset vitiligo

Conditions: Vitiligo

Summary: vitiligo is a distressing disorder of depigmentation. in spite of multiple successful therapeutic regimens, disease relapse remains a challenge to patients and physicians. most guidelines consider systemic treatments only in rapidly progressive disease with wider surface areas. this delay in halting the immune attack, may give the chance for further disease progression as well as establishment of resident memory t cell population predisposing to future disease relapses. the aim of this study was to assess the ability of early systemic therapy of localized (\<2% bsa), recent onset (\<6 months) vitiligo to control disease activity and minimize the possibility of recurrence.


Eligibility criteria:
inclusion criteria: * patients ≥ 6 years old of both genders * early onset vitiligo (˂6m duration) * body surface area (bsa) affected ≤2% exclusion criteria: * patients who received any previous treatment for vitiligo * pregnant and lactating females * patients with other cutaneous or systemic autoimmune diseases * patients with contraindication to systemic corticosteroids
effect of maolactin™ fmr on exercise recovery, inflammation, and muscle comfort in an otherwise healthy population

Conditions: Post Exercise Inflammation; Exercise Recovery; Muscle Fatigue; Muscle Pain

Summary: this is a double blind, randomised, placebo-controlled, parallel-group trial to evaluate the effect of maolactin fmr supplementation on post exercise inflammation, exercise recovery and muscle fatigue and pain in an otherwise healthy population of adults 18-65 years old over 10 weeks with 8 weeks of supplementation. this is part a of the study.


Eligibility criteria:
inclusion criteria: * adults 18-65 years old * generally healthy * bmi 19.0 - 29.9 kg/m2 * able to provide informed consent * generally active, low to moderately trained (with a minimum of 1 resistance exercise sessions per week) * agree not to change current diet and/or exercise frequency or intensity during study period * agree to not participate in another clinical trial while enrolled in this trial exclusion criteria: * undertaking high intensity exercise training and or undertaking more than 3 days of resistance training per week. * serious illness(1) e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as ms, kidney disease, liver disease or heart conditions * unstable illness(2) e.g., diabetes and thyroid gland dysfunction * unstable intake of any medication or supplement(3) * acute injuries on reporting area * current malignancy (excluding basal cell carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years * currently taking coumadin (warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy including low dose aspirin * receiving medications known to affect inflammation such as steroids * active smokers, nicotine use or drug (prescription or illegal substances) abuse * chronic past and/or current alcohol use (\>21 alcoholic drinks per week) * pregnant or lactating women * allergic to any of the ingredients in active or placebo formula * participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month * any condition which in the opinion of the investigator makes the participant unsuitable for inclusion 1. a serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments. 2. an unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. 3. an unstable intake is any dose that has changed by more than 10% of the previous dose in the past 4-weeks
tysabri observational cohort study - multiple sclerosis (ms) registries

Conditions: Progressive Multifocal Leukoencephalopathy

Summary: the primary purpose of this study is to estimate the incidence of progressive multifocal leukoencephalopathy (pml) among patients who switched to tysabri from disease modifying therapies (dmts), including newer dmts (including fingolimod, dimethyl fumarate and teriflunomide) and the established dmts (interferon beta and glatiramer acetate). researchers will also look to estimate the incidence of other serious opportunistic infections among patients who switch to tysabri from newer dmts (including fingolimod, dimethyl fumarate and teriflunomide) and the established dmts (interferon beta and glatiramer acetate)

this is an observational cohort study utilising all available data from the tysabri touch (tysabri outreach: unified commitment to health) prescribing programme (us) supplemented with data from european union (eu) multiple sclerosis (ms) registries to estimate the risk of pml and other serious opportunistic infections (ois) among patients on tysabri who have switched from newer dmts (including fingolimod, dimethyl fumarate and teriflunomide) and the established dmts (interferon beta and glatiramer acetate). this study will provide cumulative data from its two components: a retrospective component (data captured prior to 01 january 2016) and a prospective component (data captured, and patients followed up, from 01 january 2016 through 31 december 2023; total prospective study duration of 8 years). all patients who switched to tysabri from another dmt through 31 december 2020 will be included. the study will continue to follow-up patients until 31 december 2023 to allow for a minimal follow-up of 3 years.

Eligibility criteria:
key inclusion criteria: * all touch and available eu ms registry participants who have switched from dmts (including fingolimod, dimethyl fumarate, teriflunomide, interferon beta and glatiramer acetate) and have one or more infusion(s) of tysabri. key exclusion criteria: * not applicable note: other protocol defined inclusion/exclusion criteria may apply.
renal magnetic resonance angiography (mra) study comparing dotarem and time-of-flight (tof)

Conditions: Renal Disease

Summary: the study will evaluate the efficacy and safety of dotarem enhanced mra compared to tof mra in patients suffering from renal arterial disease.

each participant will undergo first a tof mra followed by a dotarem-enhanced mra.

Eligibility criteria:
inclusion criteria: * male or female, aged more than 18 years * strongly suspected of having renal arterial disease * scheduled (or to be scheduled) to undergo arterial catheter-based x-ray angiography examination exclusion criteria: * known grade iv or v chronic kidney disease (gfr\<30 ml/min/1.73m²) * contraindication to mri * acute renal dysfunction within the 6 months preceding dotarem®-enhanced mra examination

Keywords: renal disease contrast agent mra
gastroparesis in cystic fibrosis

Conditions: Gastroparesis

Summary: the purpose of this research is to determine if an investigational device called the 13c-spirulina gastric emptying breath test (gebt), can accurately diagnose gastroparesis (delayed emptying of the stomach) in patients with cystic fibrosis (cf).


Eligibility criteria:
inclusion criteria: * patients age 4 years\* and above with a genetically confirmed diagnosis of cf (\*this age was chosen as patients younger than 4 years rarely undergo ges) * actively being followed at the university of miami cf center (i.e. seen within the past 5 years at a university of miami pediatric or adult pulmonology clinic) exclusion criteria: * history of abdominal surgeries involving gastrointestinal luminal resection (i.e. small bowel or colonic resection that increases risk of post-operative strictures or narrowing of the lumen). nissen fundoplication, gastrostomy tube placement, gynecologic surgeries, appendectomy, and/or cholecystectomy are not excluded. * gastrointestinal comorbidities that impact absorption such as inflammatory bowel disease and celiac disease * known hypersensitivity to spirulina, egg, milk or wheat allergens * patients not able to consume at least 50% of a standard test meal * pregnant women * adults unable to consent * prisoners

Keywords: cystic fibrosis pediatrics altered lung function
oregon center for complementary and alternative medicine in neurological disorders

Conditions: Neurological Disorders

Summary: the mission of the oregon center for complementary and alternative medicine in neurological disorders (orccamind) is to facilitate research and education on the effectiveness and mechanisms of action of complementary and alternative medicine (cam) therapies in the treatment of neurological disorders. the integration of conventional medicine and cam communities is critical for the success of orccamind. thus, orccamind is composed of six institutions: oregon health sciences university; national college of naturopathic medicine; western states chiropractic college; oregon college of oriental medicine; the linus pauling institute at oregon state university; and the portland veterans affairs medical center. orccamind will initially focus on the use of cam antioxidants and stress reduction as treatments for neurodegenerative and demyelinating diseases because many of these diseases have oxidative injury as a causative or contributory factor and several cam approaches have direct or indirect anti-oxidant effects. through the career development program the developmental research program and the activities of the education and information core, we will also foster and promote research into other cam approaches for neurologic diseases that extend beyond anti-oxidant therapies. orccamind will achieve its goals by carrying out 4 research projects and maintaining 4 core facilities that integrate the research strengths of conventional medicine and cam practitioners and researchers. orccamind draws its strength from the multi-institutional support and the quality of all its investigators. the investigators join orcccamind with extensive experience with clinical trials, patient care, externally funded basic and clinical neuroscience research, and training programs, including federally-funded training grants. orccamind is a bold initiative that integrates basic and clinical research scientists, conventional neurologists and cam practitioners. it will promote the exploration of new areas of cam research and lead research on cam therapies for neurological disorders.

see brief summary

Eligibility criteria:
inclusion criteria: * written informed consent
bli801 laxative in constipated adults

Conditions: Constipation

Summary: a pilot study to evaluate the safety and efficacy of bli801 vs. placebo in constipated adults.


Eligibility criteria:
inclusion criteria: * constipated, defined by rome iii definition * subject has \< 3 satisfactory bms during the run-in period exclusion criteria: * subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon * subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments. * subjects who are allergic to any bli801 component * subjects taking narcotic analgesics or other medications known to cause constipation. * subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures * subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days * subjects with an active history of drug or alcohol abuse
plan of the day radiotherapy

Conditions: Cervix Cancer

Summary: the study objectives are to improve the treatment of lacc patients and to increase knowledge of the potential benefit of the plan-of-the-day concept on side effects during and after radiotherapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed cervical cancer eligible for definitve radiochemotherapy * figo stage ib1-iva * over 18 years * speaks and understands norwegian or english. * ecog 0-2 * histology: squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma * ability to understand and fill in patient questionnaires, and willing to sign a written informed consent * large movers (lm), fundus movement ≥2,5 cm. exclusion criteria: * evidence of distant metastasis. suspicious paraaortic lymphnodes below the renal vessels is allowed if they are covered by the radiation field * patients with previous surgery for their cervical cancer * uncontrolled intercurrent somatic illness. * psychiatric illness /social situations limiting study compliance * prior radiotherapy to the pelvis * patients who are pregnant or breastfeeding is excluded due to risk of teratogenic and abortifacient effects of radiotherapy and cisplatin, and the potential risk of adverse effect of nursing infants * patients under current treatment for other invasive s except non-melanoma skin cancers * nephrostomy * patients with inflammatory bowel disease