Kornimate/medical-research-clean huggingface dataset:
apico-coronal position of the implant in edentulous diabetics with implant-retained overdentures

Conditions: Diabetes Mellitus; Dental Implants

Summary: diabetes mellitus (dm) is a recognized factor affecting implant complication rates, including peri-implantitis and peri-implant bone loss, and the apico-coronal position of implants seems interfere on the conditions of peri-implant tissues. however, the influence of the vertical implant position in type 2 diabetics (t2dm) is unclear. this split-mouth randomized controlled trial evaluated the impact of implants of machined-collar placed at crestal level or supracrestally in t2dm rehabilitated with implant-retained overdentures on the clinical, tomographic and immunoinflammatory peri-implant outcomes after implant loading.

considering the outcomes achieved with implants with machined-collar inserted supracrestally, it would be relevant to investigate whether this therapeutic strategy could be considered as a more effective approach in the rehabilitation with dental implants of individuals with type 2 dm, since these patients may be more disposed to peri-implant changes, both from the point of view of marginal bone remodeling as related to local variations in immunoinflammatory response. thus, the propose of this split-mouth randomized controlled trial was to compare the impact of crestal level or supracrestally implant platform in t2dm rehabilitated with implant-retained overdentures on the clinical, tomographic and immunoinflammatory peri-implant outcomes after implant loading.

Eligibility criteria:
inclusion criteria: * the inclusion criteria included: patients aged between 50 and 80 years old, 2) totally edentulous in the mandible with previous mandibular dentures for at least 6 months and indicated for rehabilitation with overdenture, 3) patients with diabetes had to have had t2dm, diagnosed by a physician, for at least the past 5 years. such individuals were either under a dietary regimen and/or were using oral hypoglycaemic agents (metformin or glybenclamin). exclusion criteria: * exclusion criteria were: 1) pregnancy, 2) lactation, 3) current smoking or ex-smokers, 4) other systemic conditions that could affect bone metabolism (e.g., immunologic disorders), 5) use of anti-inflammatory, immunosuppressive and anti-resorptive medications, 6) patients that required bone grafts before or concomitantly with implant surgery and 7) a history of previous regenerative procedures in the area designated for implant therapy. patients with major complications of dm (i.e., cardiovascular and peripheral vascular diseases \[ulcers, gangrene, and amputation\], neuropathy, and nephropathy) were also excluded.

Keywords: dental prosthesis biological markers dental implants
families on track: a digital health behavioral intervention for parents seeking treatment for their child with obesity

Conditions: Obesity; Childhood Obesity; Hypertension; Diabetes; Dyslipidemia

Summary: current models of outpatient childhood obesity treatment focus on the child's health habits, with limited efficacy. in part, this may be because childhood obesity is highly sensitive to parental lifestyle habits, who are often not a direct target of child obesity interventions. this study aims to target weight loss among overweight parents of 2-16 year old children with obesity enrolled in the duke healthy lifestyles program (hl) in order to augment child body mass index reduction. the intervention, " families on track" is a digital health intervention platform using the interactive obesity treatment approach (iota).

parents in the program will receive the family-based treatment protocol provided by the healthy lifestyles clinic. first, families attend a half-day session at the clinic where child anthropometrics and labs are obtained, and nutrition and physical activity group counseling is provided. height and weight of the primary adult caregiver are measured and bmi is calculated. second, families return 2 weeks later to meet individually with a pediatric obesity medical provider and a registered dietitian. thereafter, frequency of visits is determined based on the families needs with a final visit 1 year after starting treatment. the ideal is to have visits with the hl staff at intervals of 4-6 weeks for 5 more visits to complete the primary phase of the program over 6 months. parents enrolled in the study will also receive the track intervention. the investigators will use a modified version of the track intervention, which utilized the interactive obesity treatment approach (iota). iota uses a computer algorithm to assign 3-4 personalized behavioral goals known to create an energy deficit to produce weight loss (e.g., sugary drinks, fast food consumption walk 10,000 steps/day, etc). the team at duke digital health has shown that iota can be successfully delivered to adults on multiple modalities -- web, text messaging and interactive voice response phone calls. each week, participants will receive a prompt from the track intervention system in order to self-monitoring these behaviors goals. these prompts will be delivered either via interactive voice response or text message. intervention participants will also receive an analog bathroom scale and a pedometer to self-monitor daily weights and steps.

Eligibility criteria:
inclusion criteria: * age: 18-60 years * bmi: 25-50 kg/m2 * english speaking * mobile phone ownership * willingness to send and receive multiple text messages/day * living in the same household as a healthy lifestyles patient ages 2-16 exclusion criteria: * current pregnancy or lactation * prior or planned bariatric surgery both child and parent participation in other obesity trials - including the evaluation of the bull city fit program at the healthy lifestyles program * history of heart attack, stroke, bipolar disorder schizophrenia or recent cancer diagnosis * plans to relocate within 1 year
exercise and activity guidance in older adults with diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of the project is to better understand how exercise and education will help mobility and health in older adults with diabetes. the investigators are trying to learn what type of exercises and classes are needed to help older adults stay active. this knowledge will eventually prove useful in helping patients and doctors understand what is needed to keep older adults with type 2 diabetes as healthy as possible.

1. information and health screening: interested persons are screened for eligibility and undergo a directed medical history and examination, echocardiogram (if not done within one year), limited abi test, and maximal treadmill test with oxygen kinetics. 2. measure fitness level at the beginning of the exercise training, at 10 and 20 weeks: dexa scan, body fat analysis, strength and balance measurements, and blood tests. 3. train for 10 weeks in a supervised small group format. classes meet three times a week for an hour. participants are randomly assigned to: 1) flexibility and toning exercises + health education, or 2) functional circuit training + home activities + tailored physical activity guidance. 4. follow-up phone calls for an additional 10 weeks.

Eligibility criteria:
inclusion criteria: * history of type 2 diabetes on medications * age 60 or older * able to attend local class 3 times per week for 10 weeks exclusion criteria: * ejection fraction \<40% * symptomatic obstructive valvular disease (primarily aortic stenosis) * atrial fibrillation with poor rate control (particularly during exercise), or high grade av block * substantial dementia (folstein mini mental state examination \<24 out of 30) * blood tests suggesting severe renal (cr\>3.0) or hepatic (transaminases\>4x normal) disease * alcohol intake \>3 oz/day * hemiplegia or lower limb amputation * participating in regular exercise 2 or more hours per week. * significant orthopedic or musculoskeletal condition that limits weight bearing * acute medical conditions, such as acute flare-up of joint condition or infection * normal fbs in those with equivocal diabetes history (\< 130)

Keywords: type 2 diabetes exercise activity guidance health education
tinnitus treatment by structured cognitive behavioral therapy

Conditions: Tinnitus

Summary: test of hypothesis that in contrast to non-treatment tinnitus specific cognitive behavioral therapy intervention procedures that are manualized and structured within the disease management program tcp are effective.

intervention: individual application of structured and tinnitus specific cognitive behavioral therapy intervention procedures in the clinical setting of the structured therapy program "tinnitus care program (tcp)" duration of intervention per patient: 1-15 treatment sessions plus self treatment up to 16 weeks control intervention: waiting group (16 weeks)

Eligibility criteria:
key inclusion criteria: * persistent and stable tinnitus of more than 11 weeks * gap between audiometric tinnitus matching and subjective tinnitus loudness rating scale key exclusion criteria: * psychiatric or neurological comorbidity * tinnitus as concomitant symptom of an otherwise treatable disease * drug treatment for tinnitus 24 hrs. prior or during therapy

Keywords: tinnitus, cognitive behavioral therapy, cbt
use of convalescent plasma for covid-19

Conditions: COVID

Summary: the plan is to transfuse covid-19 infected patients with convalescent plasma and observe whether this will result in a significant improvement in clinical outcome in comparison to historical experience.


Eligibility criteria:
inclusion criteria: * documented covid-19 infection by nasal pharyngeal sampling * covid-19 disease falling into one of the following groups: * critical disease: respiratory failure requiring mechanical ventilation, pressor support, or multiple organ dysfunction/failure * severe disease: tachypnea \>/=30 per min, o2 sats \</=93% at rest, pao2/fio2 index \</=300mmhg * high risk: upper respiratory symptoms but no radiographic evidence of disease, immunocompromised, insulin-dependent diabetes, poorly controlled hiv disease, moderate to severe asthma history, severe copd, morbid obesity (bmi \>/=40, age \>/=65 years * health care providers: health care providers at risk to exposure to covid-19 infection or those with mild to non-severe disease exclusion criteria: * history of iga deficiency * history of anaphylatic reaction to blood product transfusion including hypersensitivity to immunoglobulin therapy
continuous assessment of brain blood perfusion in subarachnoid hemorrhage patients using near-infrared spectroscopy (nirs)

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Summary: the goal of this observational study is to continuously assess cerebral autoregulation in patients with subarachnoid hemorrhage (sah) using cerebral oximetry index (cox) and hemoglobin volume reactivity index (hvx). the main question it aims to answer is: whether optimal perfusion pressure is dynamic and changes with time in patients with sah, and that autoregulation is disrupted in patients during the course of sah, contributing to delayed cerebral ischemia (dci).


Eligibility criteria:
inclusion criteria: * patients aged 18 to 89 years who are admitted to the neurological intensive care unit (neuro icu) between march 2025 and december 2026 for aneurysmal subarachnoid hemorrhage (sah). exclusion criteria: * patients under 18 years old * prisoners * pregnant women * patients enrolled in concurrent ongoing interventional trial * students of uab * employees of uab * patients who undergoes frontal decompression surgery resulting bone flap deficit where nirs monitoring pads could not be applied.
comparison of solitaire to embotrap to treat large vessel occlusion in acute ischemic stroke (soltrap study)

Conditions: Acute Ischemic Stroke

Summary: the primary aim of this study is to assess if there is a difference in first pass reperfusion between the two devices. this is a randomized prospective study to assess if there is a difference in first pass reperfusion at two centers with large mechanical thrombectomy volumes. data will also be collected on time-to treatment, outcomes and hemorrhagic complications.

the soltrap study is an investigator initiated two hospital study designed to assess the procedural success and clinical outcomes associated with mechanical thrombectomy using the medtronic solitaire device and the cerenovous embotrap device. both devices are fda approved for this indication of removal of a thrombus for patients suffering from stroke secondary to a large vessel occlusion. data collected will include device used during the procedure, mechanical thrombectomy techniques, time from onset to imaging, imaging to puncture, and overall time from onset to reperfusion as well as quality of life at 90 days post stroke. the study will enroll up to 418 subjects and will be conducted at wellstar north fulton hospital and wellstar kennestone hospital. the devices will have regulatory authorization to be on the market in the geographic location of both sites. the duration of the registry protocol is approximately 24 months

Eligibility criteria:
inclusion criteria: 1. subjects who experienced acute ischemic stroke (ais), eligible for restoration of blood flow using a solitaire or embotrap device to remove thrombus from the neurovasculature 2. occlusion of intracranial cerebral circulation vessel involving the m1, m2 mca or ica-t (tandem occlusions will be enrolled) 3. subject or subject's legally authorized representative (lar) has signed the informed consent form prior to or within 72 hours post-procedure 4. subject is willing to comply with the protocol follow-up requirements 5. the intended technique and treated technique must be one of the following techniques for the first thrombectomy pass in the neurovasculature per instructions for use (ifu). exclusion criteria: 1.the subject can participate in another clinical trial if the study does not impact the endpoints defined in this protocol given this is a data collection trial. patients who are unable to comply wit the 90 day follow up in person or via telephone will be excluded from the study.
retreatment of recurrent dupuytren's contractures

Conditions: Dupuytren's Disease

Summary: the objectives of this study are to assess the safety and efficacy of aa4500 in the retreatment of recurrent contractures in joints that were effectively treated with aa4500 in a previous auxilium-sponsored phase 3 study.

open-label, phase 4 study in subjects who are currently participating in the long-term follow-up study (ie, aux-cc-860) in the united states, australia, or europe and who have recurrence of contracture (ie, joint contracture increases by at least 20 degrees compared with the day 30 value after the last injection in a phase 3 auxilium-sponsored study and a palpable cord present) in a joint that was effectively treated (ie, reduction in contracture to 5 degrees or less 30 days after the last injection) with aa4500 in a phase 3 auxilium-sponsored study. subjects who experience recurrence of contracture in one or more effectively treated joints may be enrolled in this retreatment study after the investigator determines subject eligibility and after informed consent has been obtained. the investigator will treat the cord affecting the recurrent joint with up to three injections. only one recurrent joint will be treated in this study.

Eligibility criteria:
inclusion criteria: 1. provide written informed consent 2. be currently participating in the aux-cc-860 follow-up study 3. have at least one joint with all of the following: * the joint was effectively treated (had a correction to 5 degrees or less at the day 30 evaluation after the last injection of aa4500) in a previous auxilium phase 3 study * the effectively treated joint has an increase in contracture of at least 20 degrees compared with the day 30 value after the last injection of aa4500 in a previous auxilium phase 3 study * a palpable cord is present in the joint to be treated 4. be able to comply with the study visit schedule as specified in the protocol exclusion criteria: 1. is a pregnant or lactating female or female intending to become pregnant during the study 2. has hypersensitivity to aa4500 or any of the aa4500 excipients 3. is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for equal to or less than 150 mg aspirin daily and over-the-counter nonsteroidal antiinflammatory drugs \[nsaids\]) within 7 days before injection of aa4500

Keywords: xiaflex xiapex dupuytren's disease contracture
evaluation of teg 6s pm® during cardiopulmonary bypass to detect postoperative biological coagulopathy

Conditions: Coagulopathy; Cardiopulmonary Bypass; Cardiac Surgery

Summary: this is a prospective study to evaluate the predictive value of the teg 6s platelet mapping® (teg 6s® pm) performed during cardiopulmonary bypass (cpb) in the prediction of biological coagulopathy (determined by teg 6s global hemostasis®), in cardiac surgery with high risk of bleeding.

the aim of this prospective study is to evaluate the predictive value of the r time (hkh) given by the teg 6s platelet mapping® performed during the cpb in the prediction of postoperative biological coagulopathy. in order to evaluate its interest and to validate its use during cardiac surgery with high bleeding risk under cpb, we plan to compare 2 thromboelastographic tests in the detection of biological coagulopathy: teg 6s citrated® (reference) and teg 6s platelet mapping®. biological coagulopathy is defined by a kaolin-heparinase assay coagulation/reaction time (ckh r) value of 7 min on teg 6s citrated® (fibrinogen impairment defined by a comparison of functional fibrinogen maximal amplitude (cff ma) \< 20 mm, and ckh ma impairment (\< 60 mm), in accordance with established laboratory standard values.

Eligibility criteria:
inclusion criteria: * 18 years old or older * cardiac surgery under cardiopulmonary bypass with high risk of bleeding defined among: * cpb with circulatory arrest * cardiac transplantation * redo surgery * infective endocarditis * predicted duration of cbp ≥ 120 min * high transfusion risk defined by a trust predictive score ≥ 3 (transfusion risk understanding scoring tool) exclusion criteria: * patient with heparin allergy or heparin-induced thrombocytopenia * use of direct oral anticoagulant (daa) with anti-factor x activity (apixaban, rivaroxaban) \< 72h, even if antagonized * patient on partially or fully antagonized vkas * opposition to participation after a period of reflection * adult protected by law (guardianship, curatorship) * person deprived of liberty * person participating in another study with an exclusion period still in progress * patient not affiliated to a social security scheme or not benefiting from such a scheme * pregnant or breast-feeding woman

Keywords: coagulopathy cardiac surgery cardiopulmonary bypass
study to assess the pharmacokinetics of azd1656 during coadministration with simvastatin

Conditions: Type 2 Diabetes Mellitus

Summary: to assess the pharmacokinetics of azd1656 during coadministration with simvastatin.


Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of t2dm for at least 1 year, treated with any metformin or metformin with one other oral anti-diabetic drug (oad) * body mass index between greater than or equal to 19 and less than or equal to 42 kg/m2 * hba1c greater than 6.5% at enrollment exclusion criteria: * clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the ip * significant cardiovascular event within the last 6 months prior to enrollment (eg, myocardial infarction/acute coronary syndrome, revascularisation procedure, stroke or transient ischaemic attack) or heart failure new york heart association (nyha) class iii-iv

Keywords: type 2 diabetes mellitus glucose lowering
prognostic model of hcv-related disease progression after daas

Conditions: HCV

Summary: in this study, the investigator would conduct an ambispective cohort study to build a prediction model of hcv-related disease after daas.

the emergence of direct antiviral agents (daas) makes it possible to cure hcv, and the sustained virological response (svr) rate is up to 90% after daas therapy. however, the acquisition of svr does not mean the cure of hcv-related diseases, some patients still developed liver cirrhosis, liver cancer and other diseases after achived svr by daas therapy.in this study the investigator would like to bulid a prediction model of hcv-related disease after daas by conducting an ambispective cohort study. the participants of this study would be adult patients (≥18 years old) with chronic hcv infection and have received daa therapy, the investigator would retrospectively collected daa therapy-related information, and follow-up all the enrolled participants every 6 months to observe their liver-related disease outcomes (composite liver outcome, including liver-related deaths, hepatocellular carcinoma, liver decompensation, and liver transplantation).

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years old) with chronic hcv infection that were hcv rna positive; * have received daa treatment; * would like to adhere to the follow-up exclusion criteria: * lack of hcv treatment information;

Keywords: hcv
efficacy of red and infrared lasers in treatment of temporomandibular disorders

Conditions: Temporomandibular Disorders

Summary: the study hypothesis was that the red (600nm) and infrared (800nm) laser therapy have the same efficacy in relieving pain and improving the quality of life of tmd patients

the aim of the present study was to evaluate and compare the efficacy of red (600nm) and infrared (800nm) laser therapy in relieving pain and improving the quality of life of tmd patients.

Eligibility criteria:
inclusion criteria: * systemic health; * temporomandibular disorder diagnosed by the research diagnostic criteria for temporomandibular disorders questionnaire (rdc); * pain score ≥ 5 on palpation according to a visual and numerical scale (vns) exclusion criteria: * participants who made frequent use of analgesics, nsaids and antidepressants; * patients with previously undergone tmd treatment, or suffered facial trauma

Keywords: laser, quality of life, orofacial pain
chlorhydrate of ropivacaine and breast cancer surgery

Conditions: Breast Neoplasms; Pain,Postoperative

Summary: the aim of the study is to evaluate the effect of local anesthetic (chlorhydrate of ropivacaine) to prevent chronic pain after breast surgery for cancer.

an estimated 20-65% of women treated with breast surgery for breast cancer experience chronic pain in the treated breast. patients will be randomize between: infiltration with chlorhydrate of ropivacaine at the time of breast surgery for cancer versus placebo.intra-operative analgesia will be standardized as well as peri-operative pain management.

Eligibility criteria:
inclusion criteria: * breast cancer patients treated by conservative surgery with axillary node dissection or treated by mastectomy with or without axillary node dissection or sentinel lymph node biopsy. * asa physical status 1, 2 or 3 * with a minimum life expectancy of 2 years * written informed consent exclusion criteria: * any previous cancer other than breast cancer * allergies to local anesthesic and morphine * reported history of drug * pregnancy * homolateral breast surgery during the last 3 years * analgesic use pre-operatively * renal, pulmonary or liver major dysfunction * active malignant disease * unable to follow the protocol for any reason

Keywords: female anesthetics,local