Kornimate/medical-research-clean huggingface dataset:
biofeedback-based cognitive behavioral treatment for temporomandibular disorders

Conditions: Temporomandibular Disorders

Summary: the purpose of this study is to develop and evaluate a biofeedback-based cognitive behavioral treatment for patients with chronic temporomandibular disorders using a randomized controlled design.

the purpose of this study is to develop and evaluate a biofeedback-based cognitive behavioral treatment for temporomandibular disorders using a randomized controlled design. 100 patients suffering from chronic temporomandibular disorder are diagnosed using research diagnostic criteria for temporomandibular disorders (rdc/tmd). subsequently, patients are randomly assigned to either a psychological intervention receiving 8 sessions of biofeedback-based cognitive behavioral treatment or to a dental intervention receiving interocclusal splint therapy. assessment takes place at baseline, after treatment approximately 8 weeks later, 3 and 6 months follow up. the effects of the interventions are evaluated in terms of reduction in pain intensity, pain related disability, psychological variables such as somatoform symptoms, depression and pain related cognitive adjustment as well as nocturnal electromyographic (emg) activity. additionally, the study aims at identifying variables that predict treatment outcome. further analyses include initial changes in treatment motivation and illness perceptions and its influence on treatment success, as well as changes in psychophysiological stress reactivity through treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of painful temporomandibular disorder according to research diagnostic criteria for temporomandibular disorders (rdc/tmd) * symptoms persist at least 3 months * sufficient language skills exclusion criteria: * somatic diagnosis that requires defined somatic treatment (e.g. occlusal interference) * presence of a psychotic disorder * presence of neurological disorders (e.g. dementia) * alcohol or substance abuse * presence of other pain condition of predominant severity

Keywords: temporomandibular disorders biofeedback cognitive behavioral therapy pain
forehead lift fixation

Conditions: Forehead

Summary: to compare periosteum versus bone fixation in forehead lift.

forehead lift method of fixation is variable and lots of different methods have been described with different rates of success. the comparison of to different techniques in a rct has not been reported before. the objective is to compare periosteum versus bone fixation in forehead lift, in a randomized, blinded, controlled, split-face trial.

Eligibility criteria:
inclusion criteria: * eye brow malposition * forehead wrinkles exclusion criteria: * previous surgery * forehead trauma or scar

Keywords: plastic surgery
an exploratory study, to assess the effect of repeat-dose inhaled indacaterol maleate (300 μg) on dynamic and static lung hyperinflation, subjective breathlessness and health status in patients with chronic obstructive pulmonary disease(copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study evaluated the effect of qab149 on dynamic and static hyperinflation, breathlessness, and health status in copd patients


Eligibility criteria:
inclusion criteria: * male and female subjects, * 40 to 80 years of age, * with a documented diagnosis of mild, moderate or severe chronic obstructive pulmonary disease (copd) according to global initiative for chronic obstructive lung disease (gold) criteria and \>20-pack year history of smoking, a post-bronchodilator 40% ≤ fev1 ≤ 80% of predicted normal and post-bronchodilator fev1/fvc \< 70% who have signed an informed consent form (icf) prior to the initiation of any study-related procedure (post bronchodilator refers to 30 minutes after the inhalation of 400 µg of salbutamol) * subjects who demonstrate a plethysmographic functional residual capacity \>120% predicted normal exclusion criteria: * no copd exacerbations within 6 weeks prior to dosing, * no concomitant lung disease such as asthma, * no requirement for long term oxygen treatment or history of lung reduction surgery. * no medical conditions that would interfere with the performance of spirometry or clinical exercise testing. * any other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from participating in the study e.g. uncontrolled hypertension or unstable ischemic heart disease other protocol-defined inclusion/exclusion criteria may apply

Keywords: copd, indacaterol maleate, exercise testing
infants with agenesis of the corpus callosum

Conditions: Agenesis of the Corpus Callosum

Summary: the purpose of this study is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum.

agenesis of the corpus callosum is the most frequent brain malformation. this anomaly may be diagnosed by ultrasound screening. in half of these prenatal cases, the anomaly seems to be isolated. in this setting, there are no prospective data concerning the development of these children, preventing any clear information to be delivered to parents. prenatal diagnostic centers therefore face extremely variable rates of termination of pregnancies (top), which can reach up to 80%. this is a multicentric prospective interventional study whose primary objective is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum. evaluation at three years will include intellectual quotient (iq) quantification using the wppsi-iii, 3rd edition of wechsler preschool and primary scale of intelligence and evaluation of intra-hemispheric coordination using the vineland adaptative behaviour scale. secondary objectives will include: * circumstances leading to the prenatal diagnosis of agenesis of the corpus callosum * causes leading to termination of pregnancies * determination of criteria allowing to confirm that agenesis of the corpus callosum is isolated (family history, imagery, genetics) these results could allow to determine the optimal prenatal management of such cases.

Eligibility criteria:
inclusion criteria: * pregnant women from 28 weeks of gestation * complete agenesis of the corpus callosum * partial agenesis of the corpus callosum * abnormal corpus callosum (size, anatomy) as diagnosed by an expert ultrasound fetal brain examination. exclusion criteria: * age \< 18 years old * women who do not understand french * women not covered by the french social security system * refusal to participate

Keywords: agenesis corpus callosum prenatal diagnosis
insulin-glucose-glucagon network: defining a type 1 diabetes progression index

Conditions: Diabetes Mellitus, Type 1

Summary: the type 1 diabetes (t1d) trialnet pathway to prevention (ptp) study assesses and recruits at-risk subjects into clinical trials aimed at preventing the development of full blown t1d. thousands of first and second degree relatives of persons with t1d are screened for autoimmune abnormalities and positive subjects are followed with metabolic and autoantibody tests. the investigators' ancillary study us designed to test whether characterization of the insulin- glucose-glucagon (igg) interactions in participants in the ptp study can provide new information about the early stages of the disease. when completed, this study will improve the understanding of the pathogenesis of the early stages of t1d and provide new quantitative tools for prediction and evaluation of insulin-glucagon-glucose interactions relevant to individuals at risk for developing t1d, thereby enabling future preventive intervention trials.

the goal of the proposed ancillary studies is to establish whether characterization of the insulin-glucagon-glucose (igg) interactions in first and second degree relatives of patients with type 1 diabetes (t1d) can provide new information about the pathogenesis, prediction, and progression of the early stages of the disease. the project will enroll individuals from the "living biobank" of the trialnet pathway to prevention (ptp) study who are phenotyped with respect to a variety of risk factors, including immunological abnormalities. to the best of available knowledge, the igg relationships in general and the glucagon phenotype in particular have not been studied in this population. it is known, however, that in t1d the release of glucagon is altered, which is manifested by abnormal postprandial suppression and defective response to hypoglycemia. several reports indicate that glucagon becomes dysregulated prior to the development of t1d, but comprehensive studies aiming to understand in detail the insulin-glucagon co-dynamics in people at risk for t1d have never been performed. thus, the goal now is to expand the investigators' existing methodology and transfer expertise in clinical testing and analysis of the igg system to characterize the igg interactions in individuals at risk for developing t1d.

Eligibility criteria:
inclusion criteria: * individuals 12 to 45 years old which have a brother, sister, child, or parent with type 1 diabetes, or * individuals 12-20 years old who have have a cousin, aunt, uncle, niece, nephew, half-brother, half-sister, or grandparent with type 1 diabetes. exclusion criteria: * have diabetes already (type 1 or type 2) * have a medical condition or being been treated with medications that might interfere with the study

Keywords: diabetes mellitus, type 1 (t1dm) trialnet pathway to prevention (ptp) first and second degree relatives of persons with t1dm insulin-glucagon-glucose (igg) immunological risk to develop t1dm
bolus versus prolonged infusion of meropenem in newborn with late onset sepsis

Conditions: Late Onset Neonatal Sepsis

Summary: newborns in the neonatal intensive care unit (nicu), especially premature ones with immature organ systems, frequently suffer nosocomial infections caused by microorganisms resistant to narrow-spectrum antibiotics like ampicillin and gentamicin and require introduction of new agents with a wider spectrum of activity. meropenem has activity against wide variety of gram-negative and gram-positive bacteria. it is well tolerated by children and neonates, including preterm babies, and allowing monotherapy instead of combined therapy. severe neonatal infections with increasing antibiotic resistance are major problems affecting morbidity and mortality in the nicu. few number of new antibacterial agents entering the clinic and new agents for multi-drug resistant gram-negative bacteria will unlikely be available in the near future.

more research into existing antibiotics with novel mechanisms of action are required to combat the increased resistance and decreased development of antibiotics. efforts were exerted to maximize antibiotic efficacy by optimal dosing based on pharmacodynamic and pharmacokinetic properties of antibiotics. meropenem is administered mostly via a 30-min infusion, as some data indicate rapid degradation after reconstitution. dose recommendations from two pediatric studies using monte carlo simulation have emphasized that a 4-h infusion may be needed if microorganisms showed increased minimal inhibitory concentrations (mics), more specifically, for pseudomonas aeruginosa. a prolonged-infusion strategy has not been tested in neonates, although some data suggest that extremely small infusion volumes may significantly affect the drug amount actually delivered. aim of work: the objective of our study is to compare the clinical and bacteriological efficacy of conventional intermittent dosing of meropenem to the prolonged infusions in critically-ill neonates, with a proactive focus on reducing ventilator days in ventilated patients, length of stay in nicu, and neonatal mortality.

Eligibility criteria:
inclusion criteria: * neonates admitted to the neonatal care unit (ncu) who suffer from late onset sepsis (los) at admission or during their nicu stay and receive meropenem for at least four days exclusion criteria: * acute or chronic renal failure * hypersensitivity or allergy to meropenem

Keywords: meropenem infusion late-onset sepsis newborn management
hydroxychloroquine plus azithromycin versus hydroxychloroquine for covid-19 pneumonia (covidoc trial)

Conditions: Coronavirus Infection; Pneumonia, Viral

Summary: double blinded randomized clinical trial designed to evaluate the efficacy and safety of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with confirmed covid-19 pneumonia.

the multi-centre covidoc study will evaluate the efficacy and safety of the use of hydroxychloroquine (10 days) combined with azithromycin (5 days) compared to hydroxychloroquine (10 days) in the the clinical evolution by the ordinal scale of 7 points in adults hospitalized outside intensive care unit with pneumonia caused by infection by the sars-cov2 virus in france.

Eligibility criteria:
inclusion criteria: * 18-75 years old sars cov-2 infection confirmed by positive virologic test realised in the 96 h before randomization * beginning of covid-19 symptoms \< 10 days at the time of randomization * presence of symptom(s) of covid-19 : fever (température \> or = 37,5°c) or respiratory sign(s) (cough, breathing discomfort) or recent anosmia * presence of tdm/radiographic signs or pneumonia * hospitalization out of icu for covid with: moderate clinical form (no oxygenotherapy) or non critical severe form (oxygenotherapy) exclusion criteria: * absence of signed informed consent * spo2 \ or = 3l/min * need of oxygenotherapy \> 6 l/min or mechanical ventilation * need of hospitalization in icu * alat/asat \> 5 lsn * renal failure (egfr \< 40 ml/min ) or dialysis * pregnancy or breastfeeding * retinopathy * known deficit in g6pd * cardiac rythm / lengthening qt disorders * qt space lengthening on ecg with qtc \> 450 ms * concomitant treatment :citalopram, escitalopram, hydroxyzine, domperidone, pipéraquine, anti-arhythmic class ia \& iii, antidepressive drugs,..

Keywords: sars-cov2 virus covid-19 pneumonia hydroxychloroquine azithromycin
evaluation of bone level around stark conical screw implants with v-blast surface

Conditions: Dental Impaction

Summary: clinical evaluation of osteointegration of bone level implants (stark conical screw implants, with v-blast surface treatment), placed without sufficient primary stability.

26 implants were placed with a unique operative protocol in 4 private offices. a detailed informed consent was obtained from all patients. surgical guides were used to achieve the idea implant position and axis. osteotomy drills were used in the sequence recommended by the implant manufacturer. bone type was assessed by ct examinations using the classification proposed by rebaudi. all implants were tested by applying a lateral mild load with a probe in order to verify mobility immediately after placement. parameter used to assess a low primary stability were: * insertion torque lower than 10 n / cm * slight mobility of implant upon application of lateral load of 250 g after surgery, patients were instructed not to chew or to wear their removable dentures in the treated areas. follow-up post-operative visits were scheduled at 1 and 4 weeks. at 4-6 months after placement a periapical radiograph was taken, a torque/countertorque test of 30 ncm was conducted and osteointegrated implants were restored. patients were recalled, examined, and periapical radiographs were taken for a minimum of 6 months.

Eligibility criteria:
inclusion criteria: * patient who had received stark bone level v-blast implants in 4 private offices in italy * patient subscribed a detailed informed consent * same surgical protocol was applied exclusion criteria: * patient without stark implant

Keywords: implant stability, dental implants, primary stability
adaptation of lipid and energy metabolism during a lipid overnutrition in constitutional thinness

Conditions: Lipid Overnutrition; Constitutional Thinness

Summary: for a given food intake, fat and energy metabolism in adipose tissue and muscle adapt to nutrient intakes. this adaptation to nutrition may be impaired in susceptible individuals or in obese patients by promoting weight gain, either in constitutional thinness (mc) by blocking it. the mc is a little known entity. these patients wish to grow for her and others. can they? we have demonstrated abnormalities of hormones regulating appetite (ghrelin, pyy, glp1 and leptin) that may participate in thinness. furthermore, this thinness is associated with osteoporosis in 25% of true mc who is 25 years old.

this project aims to overfed mcs and follow the control parameters of energy metabolism. we will look for abnormalities in the adaptation to overnutrition in subjects with genetic background of thinness, which could explain the resistance to weight gain. the answer could possibly help to understand obesity.

Eligibility criteria:
inclusion criteria: * consent form the study signed * consent form for genetic study signed * normal laboratory values for liver enzymes, glucose, lipid exclusion criteria (common to the two groups): * pregnant * vegetarian * heavy smoking * heavy alcohol * depressive * taking hypolipidemic or antihypertensive drugs * dyslipidemia

Keywords: thinness leanness healthy volunteers lipid metabolism disorder
study on efficacy, pharmacokinetics, and safety of two subcutaneous injections of triptorelin embonate 6 month formulation in patients with advanced prostate cancer

Conditions: Prostate Cancer

Summary: the primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered by the subcutaneous (under the skin) route in: * achieving castrate levels of testosterone (\< 1.735 nmol/l) on day 29 \[i.e., 28 days after investigational medicinal product (imp) injection\], and * in maintaining serum testosterone castrate levels from month 2 (day 57) to end of month 12 (day 337) in participants with advanced prostate cancer.


Eligibility criteria:
summary inclusion criteria: * meets protocol-specified criteria for qualification and contraception * is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications * voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures summary exclusion criteria: * has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters * has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results
high concentration of sugar solution irrigation promotes the healing of infected wound

Conditions: Wound Infection; Sugar Solution

Summary: surgeons easily get wound infections. most wound infections will be cured by applying medicines and changing dressing in very short period of time. but some wounds are severely contaminated combined with fat liquefaction, crateriform ulcer and large undermined lacuna, so changing dressing takes a very long time. in order to better change the dressing, it needs to expose the wound thoroughly, which requires to completely open the healed skin, so the healing will be slowed down. some scholars lay stress on prevention. wound infection control concerns prevention--not therapy--of an infrequent but expensive kind of surgical morbidity.(1.2)some scholars think that the main armamentarium of the attack is the use of topical anti-infectives, which invade the bacteria where they reside, and, consequently, reduce their numbers and promote wound healing.(3)for example, silver is reemerging as a viable treatment option for infections encountered in burns, open wounds, and chronic ulcers. but it is expensive and is difficult to acquire silver-containing dressings. and recent findings, however, indicate that the compound delays the wound-healing process and that silver may have serious cytotoxic activity on various host cells. (4) as high concentration of sugar solution, honey appears to heal partial thickness burns more quickly than conventional treatment (which included polyurethane film, paraffin gauze, soframycin-impregnated gauze, sterile linen and leaving the burns exposed) and infected post-operative wounds more quickly than antiseptics and gauze.(5)this study involve the use of another high-concentration of sugar solution (hcss) to lavage infected wounds when changing dressings.


Eligibility criteria:
inclusion criteria: 1. patients conducted surgical operation in the hospital within 2 weeks. the wound had swelling and lots of secretions; 2. except for the incision, primary surgical site has been recovered smoothly. patients didn't accept secondary operation in the same site; exclusion criteria: 1. except for the wound that can't use healthy skin closure in phase i
study to assess the safety and effectiveness of the penumbra system

Conditions: Stroke

Summary: this clinical evaluation is a prospective, single-arm, multi-center trial. the purpose of this clinical evaluation is to assess the safety and effectiveness of the penumbra system in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.

purpose: the purpose of this clinical evaluation is to assess the safety and effectiveness of the penumbra system in the revascularization of patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease. up to 125 evaluable patients will be enrolled in the study.

Eligibility criteria:
inclusion criteria: * clinical signs consistent with acute ischemic stroke * 18 to 79 years of age * neurological deficit resulting in an nih stroke scale (nihss) score \> 8 * timi 0 or timi i flow in vessels accessible to the penumbra system * signed informed consent * present within 8 hours of stroke symptom onset; ineligible or refractory to intravenous tissue plasminogen activator (t-pa) therapy if presenting within 3 hours of symptom onset. exclusion criteria: * evidence of rapidly improving neurological signs of stroke at time of enrollment * nihss \> 30 or coma * females who are pregnant * vessel tortuosity too difficult to allow endovascular access * known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an international normalized ratio (inr) \> 3.0 * partial thromboplastin time (ptt) greater than 2 times the lab normal * admission platelets \< 30,000 * pre-existing neurological or psychiatric disease that could confound the study results * known severe allergy to contrast media * uncontrolled hypertension * computed tomography (ct) evidence of significant mass effect with a midline shift * ct reveals evidence of large hypodensity region \> 1/3 of the middle cerebral artery territory * ct reveals evidence of intracranial hemorrhage * ct reveals significant mass effect with midline shift * angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal * angiographic evidence of preexisting arterial injury * life expectancy of less than 90 days * participation in another clinical investigation that could confound the evaluation of the study device.

Keywords: penumbra ischemic stroke intervention neurovascular thrombus embolectomy ischemic stroke