Kornimate/medical-research-clean huggingface dataset:
longitudinal monitoring of microsurgical socket augmentation healing with ultrasonography

Conditions: Healing Wound

Summary: the purpose of this study is to assess healing after tooth extraction with simultaneous socket augmentation (bone grafting during the same appointment as the extraction) when the surgeon uses a surgical microscope, compared to when the surgeon uses dental loupes (magnifiers that are mounted on the surgeon's glasses). these devices magnify and shine light on the area where the surgeon operates.

after a tooth is extracted, a hole is left in the bone called a socket. during the first year of healing after a tooth extraction, there may be up to 60% loss of bone volume at the site. loss of bone at the edentulous ridge (toothless area) may make it more difficult to place dental implants later. dental socket grafting is performed to reduce bone resorption after tooth extraction. grafting involves filling the socket with bone graft (donated human cadaver derived) and covering it with a protective collagen membrane. this graft prevents resorption of the ridge and is slowly replaced with the patient's own bone. the investigators will be trying to determine if bone healing is better if the surgeon uses more powerful magnification.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age 2. single maxillary or mandibular hopeless tooth (a maxillary or mandibular anterior tooth or premolar) planned for extraction due to periapical pathology with a minimum ≥2 mm of the size of the periapical radiolucency shown on a peri-apical film. 3. the patient is planned for implant restoration for the hopeless tooth 4. the study site allows for implant placement with or without additional bone augmentation procedures after the healing 5. adequate edentulous space for the final restoration on the implant exclusion criteria: 1. current smokers or quit smoking less than 6 months 2. major or uncontrolled medical conditions, e.g. poorly controlled diabetes mellitus (hba1c \>8.0%, uncontrolled systemic disease or condition known to alter bone metabolism, e.g. osteoporosis, osteopenia, hyperparathyroidism, paget's disease, etc. 3. pregnancy, breast-feeding, could be pregnant or planning to become pregnant in the next 4 months (self-reported) 4. taking medications known to modify bone metabolism (i.e. bisphosphonates, corticosteroids, hormone replacement therapy)
effect of kangaroo care and swaddling methods on pain level and crying time during heel blood collection

Conditions: Pain, Acute; Newborns; Crying

Summary: this prospective study is planned as a randomized controlled study with the purpose of determining the effect of kangaroo care and swaddling methods on pain levels and crying times by newborns during heel blood collection.

among the non-pharmacological methods frequently used to reduce the effects of invasive interventions on the newborn; practices such as reducing environmental stimuli, individualized developmental care, music therapy, breast milk, pacifier giving, sucrose, non-nutritive sucking, oral sucrose, kangaroo care, facilitated tucking position, and sweet solutions, massage and touching, positioning, nesting, kangaroo care, fetal positioning are included. this study is a prospective, randomized and controlled trial. in this study aim, the effect of kangaroo care and swaddling methods applied during heel blood collection on the pain levels and crying times in newborns will be examined. sample of the study consisted of a total of 120 newborns who met the sample selection criteria and were selected via randomization method. newborns were divided into three groups; kangaroo care group (n=40), swaddling group (n=40), and control group (n=40). data were collected using the infant-family information form, nips - neonatal infant pain scale, and crying follow-up form.

Eligibility criteria:
inclusion criteria: * parents who volunteered and gave consent to participate in the research * full term neonates (38-42 weeks of gestation) * underwent heel stick blood drawing for routine metabolic screening, * aged 1 to 4 days * passed the hearing screening * birth weight between 2500-4400 grams * parents who know how to read, write and speak turkish. exclusion criteria: * parents with any mental problems * infants with any chronic disease and congenital anomalies.

Keywords: newborn pain crying time kangaroo care swaddling heel stick
influence of the pepa membrane on the undernutrition syndrome inflammation in chronic hemodialysis

Conditions: ESRD

Summary: nutripepa2 is a randomized, single-blind, prospective, multicenter trial, in two parallel arms to confirm that the adsorbent pepa membrane may decrease mortality related to inflammation and malnutrition encountered in hd or hdf-treated stage 5 renal failure compared to a non-adsorbent synthetic membrane.

the objective of nutripepa2 study is to demonstrate that the use of an adsorbent membrane (pepa-poly ester poly arylate synthetic co-polymer membrane) decreases undernutrition (often associated with inflammation) and consequently morbidity, comparing one year mortality in patients with chronic kidney disease (ckd), with severe protein-energy wasting (pew), treated with dialysis using a non-adsorbent synthetic membrane (polysulfone or polyethersulfone) versus an adsorbent membrane (pepa).

Eligibility criteria:
inclusion criteria: * patient with chronic renal insufficiency stage 5, treated by fistula or permanent catheters, * medium albumin (on 3 recent assays) of less than 35 g / l (this assay being carried out by a non-electrophoretic technique), * pini score greater than or equal to 1, * beginning of the treatment of extra-renal purification by hemodialysis for at least 3 months on a non-adsorbing synthetic membrane (of the polysulfone, polyethersulfone, polyarylethersulfone type) of surface at least equal to that of the pepa dialyser exclusion criteria: * patients allergic to pepa, * patients with insufficient vascular access, * patients with digestive syndromes: hepatopathy, gastrointestinal amyloidosis, chronic diarrhea, myeloma and dysglobulinaemia, neoplasia and hematopathy, a serious illness that is life-threatening in the short term,
outcomes in emergency laparotomies during covid-19 pandemic

Conditions: COVID-19; Emergency General Surgery

Summary: nlr has previously been observed to correlate with complications in upper gi (1) and colorectal (2) surgery. the investigators sought to assess if a similar correlation can be identified in emergency general surgical patients and if the presence of suspected or confirmed covid-19 may impact on this. given the heterogeneity of emergency general surgery the investigators therefore plan to perform a retrospective review of patients having emergency laparotomies only at a single nhs site during covid-19 pandemic. assessment of outcomes and neutrophil:lymphocyte ratio as a predictor of outcomes will be completed. outcomes will be completed in line with the recent covidsurg study criteria (3). the primary outcome is 30-day mortality. secondary outcomes are 7-day mortality, re-operation, length of stay, post-operative respiratory failure, post-operative ards (acute respiratory distress syndrome), post-operative sepsis and itu (intensive therapy unit)/hdu (high dependency unit) admission.


Eligibility criteria:
inclusion criteria: * patients undergoing emergency laparotomy (change made due to heterogeneity of emergency general surgery) exclusion criteria: * inherited or acquired immunodeficiency (which may directly skew nlr)
bioelectrical impedance analysis as a bedside tool to estimate volume of distribution of hydrophilic antimicrobials in critically ill patients

Conditions: Electric Impedance; Pharmacokinetics; Capillary Leak Syndrome

Summary: bioelectrical impedance analysis is studied as a bedside tool to estimate capillary leak in order to guide dosing of hydrophilic antimicrobials.

abstract background: recent data suggest that antimicrobial pharmacokinetics (pk) like volume of distribution (vd) or drug clearance (cl) is extremely altered in critically ill patients with sepsis or septic shock due to pathophysiological alterations (e.g. influence on fluid status). bioelectrical impedance analysis (bia) was recently introduced as a simple, non-invasive, bedside technique to assess hydration status. the primary aim of the present study was to explore the correlation between bia parameters and vd of hydrophilic antimicrobial agents in critically ill patients. furthermore, the relationship between bia measurements and clinical observations was evaluated. methods: we performed a validation study in healthy volunteers in september 2015 that confirmed the reproducibility of bia. subsequently, a prospective observational study was carried out in eligible patients treat-ed with amoxicillin/clavulanic acid, meropenem, piperacillin/tazobactam or vancomycin, admitted at the in-tensive care unit (icu) of the university hospitals leuven from october 2015 to march 2016. bia measurement was performed on the same day as the collection of blood samples to calculate pk parameters of the administered antibiotic.

Eligibility criteria:
inclusion criteria: * admitted to icu ward * treated with one of the four studied antimicrobials exclusion criteria: * \<18 years * pregnant * do not resuscitate code 2 or 3 * renal replacement therapy * ecmo * pacemaker/defibrillator * extended burns or dermatological ilness

Keywords: distribution volume antibiotics
outcomes of prophylactic swallowing therapy in patients undergoing definitive chemoradiation for head and neck cancer

Conditions: Head and Neck Cancer; Oropharynx Cancer

Summary: clinician directed prophylactic swallowing therapy will improve immediate (four weeks +/- two weeks) and short-term (26 weeks +/- four weeks) post-treatment swallowing function and quality of life versus patient directed home exercises. the purpose of this prospective, interventional, pilot investigation is to determine whether clinician directed swallowing therapy will improve patient swallowing function outcomes and quality of life in the immediate and short-term basis compared to patients receiving standard of care patient directed independent home swallowing therapy. patient compliance with home exercises programs is reportedly inconsistent. patients may experience changes in their physical functioning and overall well-being that may impact their ability to follow-through with independent home therapy. clinician directed swallowing therapy allows for ongoing assessment of changes that may warrant modifying the therapy program in terms of intensity of exercises and/or expectations. this facilitates individualizing the patient's therapy plan to maximize their function and ability to achieve goals. it is anticipated that individualizing swallowing therapy through weekly session will result in improved swallowing function.

this is a single-site, two-arm, 1:1 randomized, prospective, interventional, pilot study to determine whether clinician directed swallowing therapy will improve patient swallowing function outcomes when compared to patient-directed home-based swallowing therapy. the investigators anticipate at least 40 subjects will need to be enrolled/consented in order to obtain the accrual goal of 15 evaluable subjects for each group for a total of 30 participants. all subjects in each group will receive a face-to-face education session with a speech pathologist to review a recommended program of swallowing exercises prior to initiation of chemoradiation at their baseline (pre-treatment evaluation session).

Eligibility criteria:
inclusion criteria: 1. diagnosis of head and neck cancer (sites: oropharynx: human papillomavirus (hpv) related and non hpv related tonsil and base of tongue) 2. scheduled to undergo definitive chemoradiation therapy 3. at least 18 years of age or older 4. subject must have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. surgical management in addition to chemoradiation therapy; 2. cancer of the sinus, brain, or parotid; 3. prior treatment for head and neck cancer; 4. receiving chemoradiation treatment at an outside institution (i.e., non-university of miami (um) clinic); 5. prior history of dysphagia unrelated to the current diagnosis of head and neck cancer; 6. prior neurologic disorder (i.e., cerebrovascular accident (cva), traumatic brain injury (tbi), dementia) or current degenerative neuromuscular disease; 7. history of prior c-spine surgery; 8. history of prior vocal fold immobility

Keywords: prophylactic swallowing therapy
pharmacological and nonpharmacological methods for children in venipuncture pain

Conditions: Procedural Pain Relief; Fear Pain

Summary: this study aimed to examine the effect of emla cream, cold spray, and buzzy applied during venipuncture on the pain and fear levels of children aged 7-12 years.

the international guide to pediatric anesthesia (good practice in postoperative and procedural pain) recommends pharmacological and nonpharmacological methods to effectively manage and prevent acute procedural pain in children. nonpharmacological methods alone or in combination with pharmacological methods help reduce pain, and therefore, have become popular especially in recent years. for pain management, nonpharmacological methods are easy to use, and cost- and time-effective methods with no side effects. studies have evaluated a large number of pharmacological and nonpharmacological interventions for procedural pain management in children. however, most of those interventions are not used by healthcare professionals because they are expensive, time-consuming or hard to use. therefore, easy-to-use, practical, non-invasive, cost-effective, and reusable pharmacological and nonpharmacological methods can be used especially in acute settings. emla cream, cold spray, and buzzy examined in this study may serve as alternative effective pharmacological and non-pharmacological methods to reduce venipuncture pain and fear.

Eligibility criteria:
inclusion criteria: * being between the ages of 7 to 12 years, * literate, * requiring blood tests exclusion criteria: * having chronic diseases, * hospital stay for treatment, * visual, audio, or speech impairments, * a history of allergies, * mental disorders, * history of sedative, analgesic, or narcotic use within 24 h before admission, * inflammatory disease during admission.

Keywords: procedural pain venipuncture children
multiplex testing for breast cancer susceptibility: a pilot study of subject preferences for information and responses after testing

Conditions: Breast Cancer

Summary: the purpose of this study is to find out what kinds of information people would like to receive from a new kind of genetic testing, and how they respond to this new kind of testing.


Eligibility criteria:
inclusion criteria: * male or female age 18 or older * personal history of breast cancer and one of the following: * invasive breast cancer or dcis diagnosed at or before age 45 invasive breast cancer diagnosed at/before age 50 with one or more of the following: * limited family history (fewer than 2 first- or second-degree female relatives in the same lineage that lived to age 45. the "limited family history" can occur on either the maternal or paternal side of the family.) * 1 or more first-/second-degree relatives with invasive bc at/before 50 * 1 or more first-/second-degree relatives with invasive epithelial ovarian cancer (any age) * 1 or more first- or second-degree relatives with male breast cancer * 2 or more first- or second-degree relatives with pancreas cancer * invasive breast cancer diagnosed at or before age 60 with at least 2 first or second-degree relatives affected with any combination of invasive breast cancer before age 50, invasive epithelial ovarian cancer at any age, male breast cancer, or pancreas cancer. * full sequence brca1 and brca2 testing completed with no deleterious mutation identified. exclusion criteria: * unable to provide informed consent for testing * unable to complete english language questionnaire

Keywords: brca1 testing brca2 testing 13-215
hyperbaric oxygen treatment ameliorates insulin resistance

Conditions: Obesity; Type 2 Diabetes

Summary: obesity is an epidemic in western society and is the biggest risk factor for insulin resistance and type 2 diabetes. the investigators have preliminary evidence showing that hyperbaric oxygen therapy rapidly increases insulin sensitivity in humans. this requires confirmation in a larger population, and with this study the investigators will also test for mechanisms how this occurs. the investigators suspect that modulation of hypoxia and stress response proteins following changes in tissue oxygenation may contribute to these improvements. this study has the potential to yield new and important insights into the insulin resistance in obesity.


Eligibility criteria:
inclusion criteria: * obese men with and without type 2 diabetes aged 45-70 * lean men without type 2 diabetes aged 45-70 exclusion criteria: * smokers * claustrophobic * sleep apnoea * blood donor * exercise more than 2 times per week * under certain medications eg: bleomycin,corticosteroid

Keywords: insulin resistance inflammation hypoxia
a trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic parkinson's disease

Conditions: Parkinson's Disease

Summary: the objective of this trial is to compare the effect of rotigotine (spm 962) and ropinirole on the control of early morning motor impairment and sleep disorders in subjects with early-stage pd. subjects who meet eligibility criteria will be randomly assigned either to rotigotine transdermal patch or ropinirole tablets. trial medication will be titrated for rotigotine and ropinirole until an individual optimal dose is achieved. following a titration period of up to 4 weeks in the rotigotine arm and 6 weeks in the ropinirole arm, subjects will be maintained on the optimal or maximal dose for 4 weeks. at the end of the maintenance period, subjects will be given the opportunity to enter a 2-year rotigotine patch extension trial. the first subject was enrolled in december 2004. the last subject was enrolled in june 2005. last subject out is expected for october 2005. the trial is still ongoing.


Eligibility criteria:
inclusion criteria: * early-stage, idiopathic parkinson's disease

Keywords: early-stage, idiopathic parkinson's disease
postoperative respiratory depression after cardiac surgery

Conditions: Coronary Artery Disease

Summary: coronary artery bypass graft surgery (cabg) is associated with postoperative respiratory depression. in this study we aimed at investigating perioperative parameters that could predict the nadir of postoperative respiratory function impairment.

coronary artery bypass graft (cabg) surgery is a principal revascularization option for ischemic heart disease and the principal modality for invasive treatment of coronary artery disease. postoperative pulmonary complications are the most frequent and significant contributor to length of hospitalization, morbidity and mortality. the objective of this study is to search for perioperative parameters that could predict the degree of impairment of respiratory function after cabg with cardiopulmonary bypass (cpb).

Eligibility criteria:
inclusion criteria: * patients of both sexes older than 18 years submitted to cabg with cpb, presence of coronary disease confirmed by coronary angiography, use of the left internal thoracic artery and/or saphena, patients who remained in spontaneous ventilation on the first postoperative day, absence of chronic or acute pulmonary disease, and giving written informed consent to participate in the study. exclusion criteria: * intraoperative change of the surgical technique, surgical complications or complications occurring in the icu, emergency reoperation, renal failure, failure to agree to continue in the study, presence of other types of heart disease, and presence of pulmonary diseases.

Keywords: coronary artery bypass surgery cardiopulmonary bypass icu postoperative respiratory depression
ispinesib in combination with capecitabine in patients with solid tumors

Conditions: Solid Tumor Cancer

Summary: the purpose of this study is to determine the dose regimen of ispinesib in combination with capecitabine in patients with solid tumors. ispinesib is dosed by 1-hour intravenous infusion every 3 weeks and capecitabine is dosed orally, twice a day for 14 days with a 1 week rest period. a patient may continue to receive treatment as long as they are benefiting from the treatment. blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. physical exams will be performed before each treatment with ispinesib. during the treatment phase, the patients will undergo regular assessments for safety and clinical response.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy. * ecog (eastern cooperative oncology group) performance status of 0-2. * bone marrow function: - anc greater than 1500/mm3. * platelet count greater than or equal to 100,000/mm3. * hemoglobin greater than 9 g/dl. * renal function: - calculated creatinine clearance greater than or equal to 50 ml.min. * total bilirubin greater than 1.5 mg/dl. * ast/alt less than 2.5 x upper limit of normal. exclusion criteria: * females who are pregnant or nursing. * pre-existing hemolytic anemia. * pre-existing peripheral neuropathy greater than or equal grade 2. * known deficiency in dihydropyrimidine dehydrogenase (dsd).

Keywords: safety tolerability dose limiting toxicity solid tumors capecitabine
pilot trial of a system for motor function recovery

Conditions: Spinal Cord Diseases

Summary: this is a multi-center, prospective, blinded, pilot feasibility study to evaluate improvement in sensory and motor function with sham.


Eligibility criteria:
inclusion criteria: * traumatic chronic spinal cord injury exclusion criteria: * active implanted medical device * internal metallic objects of unknown or foreign origin * implanted anti-spasticity pumps, botox injections in prior 3 months or other current anti-spasticity regimen * bmi \> 40.0 * acute medical conditions under active treatment that would contraindicate standard rehabilitation including open wounds * pregnancy or planned pregnancy * unhealed bone fractures, peripheral neuropathies or painful musculoskeletal dysfunction * cardiopulmonary disease or ventilator dependency * uncontrolled epilepsy or seizures * clinically significant depression, psychiatric disorders or ongoing substance abuse