Kornimate/medical-research-clean huggingface dataset:
recombinant human platelet-derived growth factor in combination with collagen matrix

Conditions: Gingival Recession; Platelet Derived Growth Factor

Summary: the present randomized clinical trial is aimed at evaluating the efficacy of recombinant human platelet-derived growth factor in combination with collagen matrix for the treatment of multiple adjacent gingival recessions

despite the fact that gingival recession is most often a generalized condition rather than being localized to a single tooth, most of the data currently found in the literature pertains to the treatment of localized gingival recessions. the gold standard treatment for this condition involves the use of an autogenous connective tissue graft, that is associated with increased patient morbidity. biomaterials have progressively gained popularity due to their advantages when compared to autogenous grafts, such as unrestricted availability, avoidance of a secondary surgical site, reduction of the surgical time, and the patient's preference. collagen matrix is one of the most used soft tissue substitute for the treatment of gingival recessions. combining this scaffold material with a growth factor could enhance its outcomes. in particular, root coverage using platelet-derived growth factor can also promote regeneration of new cementum, periodontal ligament and bone. therefore, the aim of the present study is to investigate the effect of platelet-derived growth factor in combination with collagen matrix outcomes for the treatment of multiple adjacent gingival recessions.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * periodontally and systemically healthy * full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth) * at least two multiple adjacent gingival recessions (with at least one 2 mm or deeper) requiring surgical intervention for root coverage * no interproximal attachment/bone loss * no prior experience of root coverage procedures within the last 1 year * the patient must be able to perform good oral hygiene exclusion criteria: * contraindications for periodontal surgery * patients pregnant or attempting to get pregnant (self-reported) * untreated periodontitis * persistence of uncorrected gingival trauma from traumatic toothbrushing * interdental attachment loss greater than 1 mm or furcation involvement in the teeth to be treated * presence of severe tooth malposition, rotation or clinically significant super-eruption * self-reported current smoking more than 10 cigarettes/day or pipe or cigar smoking * allergy to collagen-based medical products
addition of pyridoxine to prednisolone in infantile spasms

Conditions: Infantile Spasms

Summary: infantile spasms constitute a unique age specific epilepsy syndrome of infancy, characterized by epileptic spasms often accompanied by neurodevelopmental regression and an eeg finding of hypsarrhythmia. when all 3 components are present, the eponym "west syndrome" is commonly used. west syndrome is a catastrophic epileptic encephalopathy. it does not respond well to standard anti-epileptic drugs. hormonal therapy is the mainstay in the treatment of infantile spasms. this includes adreno-cortico trophic hormone (acth) and oral steroids. variable dose of prednisolone used in the treatment. oral prednisolone used in usual dose (2mg/kg) has been shown to be less effective as compared to acth. high dose prednisolone (4mg/kg) has been used in the treatment of infantile spasms, which has been shown to be as effective as acth. pyridoxine has been used as first line treatment in japan, however there is paucity of data on the efficacy of combination of pyridoxine with hormonal therapy. there are no studies comparing add on pyridoxine with high prednisolone versus high dose prednisolone alone in the treatment of infantile spasms. therefore the study has been planned to see whether the addition of pyridoxine with high dose prednisolone in the treatment of infantile spasms improves the efficacy in terms of spasm cessation.


Eligibility criteria:
inclusion criteria: 1. age in 3months-3years. 2. presence of epileptic spasms (1 or more clusters per day) with eeg evidence of hypsarrythmia or its variants. - exclusion criteria: 1. children with active systemic illness 2. children with evidence of active tuberculosis 3. severe acute malnutrition (standard deviation scores below median weight for height) 4. children with recurrent illness/chronic systemic illness 5. prior treatment of pyridoxine, steroid, or acth. -
motivational interviewing to improve self management in youth with type 1 diabetes

Conditions: type1diabetes

Summary: a brief, nurse-led educational intervention using motivational interviewing substantially improved general and disease-specific self-management skills in youth with type 1 diabetes.

introduction and objectives: for youth with chronic health conditions, adolescence is associated with a deterioration of disease self-management and poor health outcomes. effective interventions are needed to prepare youth for transition to adulthood and adult care. to prospectively assess the impact of an education program based on motivational interviewing on self-management skills and glycemic control in youth with type 1 diabetes (t1d). methods: after parental consent and youth assent, investigators prospectively randomized 66 adolescents 13-18 years old with type 1 diabetes to either usual care (regular medical consultation) or usual care supplemented by sessions with a nurse educator using a motivational interviewing (mi) approach and goal setting based on responses to the transition readiness assessment questionnaire (traq) and t1d specific self-management skills. primary outcomes were traq change scores and hba1c levels between baseline and 6 months.

Eligibility criteria:
inclusion criteria: * being diagnosed with type 1 diabetes * having an age between 13 and 18 years exclusion criteria: * having a neurological disability (epilepsy, autism) * having a significant intellectual delay, which might have affected their ability to understand the content of the program

Keywords: adolescent transition to adult care type 1 diabetes
retrospective encore reverse shoulder prosthesis study

Conditions: Rotator Cuff Deficiency; Glenohumeral Arthritis

Summary: the purpose of this study is to evaluate the survivorship and efficacy of the encore reverse shoulder prosthesis in a group of no more than 50 subjects for whom data collection has already begun.


Eligibility criteria:
inclusion criteria: * the rsp is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. * the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. * the glenoid baseplate is intended for cementless application with the addition of screws for fixation. the humeral stem is intended for cemented use only. exclusion criteria: * infection or sepsis * insufficient bone quality which may affect the stability of the implant, as determined by the physician * muscular, neurological, or vascular deficiencies, which compromise the affected extremity * alcoholism or other addictions * materials (metals, etc) sensitivity * loss of ligamentous structures * high levels of physical activity * non-functional deltoid muscle
study to evaluate the efficacy of n-acetylcysteine (nac) in the treatment of the common cold and cough

Conditions: Common Cold Associated With Cough

Summary: this study is designed to improve knowledge regarding the initial effectiveness of n-acetylcysteine (nac) on cold and cough symptoms.


Eligibility criteria:
inclusion criteria: * cold/urti symptoms occurring no more than 4 days * cough due to a cold or acute viral (urti) with an onset of no more than 3 days * cough frequency with specified cut-off exclusion criteria: * a subchronic, or chronic cough (cough duration \> 2 months) due to any condition other than a cold/urti * diagnosed as suffering from any pulmonary conditions associated with cough, e.g., chronic obstructive pulmonary disease (copd), acute or chronic bronchitis, asthma, cystic fibrosis * taking any medications known to induce cough * fever of greater than 39°c (102°f) orally * complication of the common cold like otitis media, severe sinusitis, or pneumonia * other protocol-defined inclusion/exclusion criteria may apply

Keywords: n-acetylcysteine adults cough and cold
study evaluating pharmacovigilance of refacto af

Conditions: Hemophilia A

Summary: the purpose of this observational study is to describe the incidence of adverse events among patients treated with refacto af in usual health care settings in germany and austria.

non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility criteria:
inclusion criteria: * patients with hemophilia a of any severity already receiving or starting treatment with refacto af. exclusion criteria: * patients with hemophilia a treated with a product other than refacto af.
pharmacological study of cefazolin antibioprophylaxis in liver transplantation

Conditions: Liver Transplant Infection; Surgical Site Infection; Antibiotic Prophylaxis; Cephazolin Adverse Reaction

Summary: this study describes cefazolin pharmacokinetics variation to target levels during liver transplantation.

cefazolin is one of the many drugs used in antibiotic prophylaxis during liver transplantation. however there are no study describing its pharmacokinetics during liver transplantation. due to the severe pharmacokinetics interactions caused by both prior hepatopathy and surgical techniques we suppose that cefazolin blood levels are very different from those targeted for antibiotic prophylaxis. this study aim to describe pharmacokinetics of cefazolin during liver transplantation in order to adapt antibiotic prophylaxis strategy in case of unadapted measured levels.

Eligibility criteria:
inclusion criteria: * age over 18 * patient undergoing liver transplantation * receiving cefazolin as perioperative antibiotic prophylaxis to prevent surgical site infections exclusion criteria: * pregnant women * legal protection or protected adults * ongoing antibiotic treatment before liver transplantation * patient inability to receive information or express opposition to the study. * patient refusing participation

Keywords: antibiotic prophylaxis liver transplant surgical site infection cefazolin
reliability of longshi scale with remote assessment

Conditions: Stroke; Telemedicine

Summary: to explore the reliability of remote longshi scale assessment with smartphone video calls by comparing the consistency of remote assessment and bedside assessment, as well as the test-retest reliability of the remote assessment. the evaluation duration of these two methods was recorded and the level of satisfaction of patients and evaluators was investigated.


Eligibility criteria:
inclusion criteria: * a.stroke survivors 1. aged 18 and above; 2. diagnosed with cerebral infraction or intracerebral hemorrhage; 3. stroke onset2 weeks; 4. stable vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation and temperature); 5. voluntary or guardian consent to participate in the study. b.evaluators 1. registered rehabilitation practitioner; 2. experience in rehabilitation scientific research or education related work for more than two years exclusion criteria: * a.stroke survivors 1. brain tumor, parkinson's disease or active epilepsy within past three months; 2. a history of mental illness such as mania or delirium; 3. participation in any other clinical study. b.evaluators 1. unable to finish the training of longshi scale or use smartphones proficiently.

Keywords: stroke tele-rehabilitation activities of daily living
health behavior change during covid-19 pandemic

Conditions: Health Behavior

Summary: this study aims at investigating handwashing behavior during covid-19 pandemic. it was hypothesized that social-cognitive and emotional predictors as well as covid-19 morbidity and mortality rates within the country would be associated with handwashing behavior in the general population of adults in 14 countries.

this observational study aims at testing the adherence to handwashing guidelines (the world health organization, who, 2020) at two measurement points, spanning 1 month. adults from the general population in 14 countries (poland, australia, canada, china, france, gambia, germany, israel, italy, malaysia, portugal, romania, singapore, switzerland) will provide self-report data on handwashing behavior and its social-cognitive predictors (perceived effectiveness of handwashing, risk perception, outcome expectancy, self-efficacy, intention, planning, and action control), anxiety, as well as covid-19 morbidity and mortality rates within the country.

Eligibility criteria:
inclusion criteria: * adults (from general population) who provided informed consent to participate exclusion criteria: * younger than \<18 years old

Keywords: general population adult handwashing social cognition anxiety covid-19
link between the peripheral mononuclear cells' capacity to induce insulin resistance and hyperinsulinemia

Conditions: Insulin Resistance; Hyperinsulinism; Immune System

Summary: this is a two-center proof-of-concept study, ancillary to the metactiv study, whose objective is to define immune activation profiles from the data of individuals followed by the caisse primaire d'assurance maladie du gard (health insurance fund). the iractiv study will include a subset of volunteers from the metactiv study for whom a blood sample will be taken as part of the iractiv study.

the local health insurance fund regularly offers people who have already had a free health check-up the opportunity to re-do a check-up. this invitation will be made as part of the routine, by mail. people who have participated in the metactiv study will be asked to participate in the present iractiv study ( they will be sent an information note). that way, up to 30 volunteers who previously participated in the metactiv study, including 10 for whom a particular profile has been identified will be recruited again in sequence. on the day of consultation at the gard health insurance fund, consent will be collected from subjects who have agreed to participate. the participation of the volunteers will be reduced to this single visit and 16 ml of blood will be collected on edta for the purpose of this study. as in the previous metactiv study, this blood will be transported to the biological resource center at nîmes university hospital. from this blood, the plasma will be frozen and stored at -80°c for subsequent determination of insulin levels under the same conditions as for the metactiv study. peripheral blood mononuclear cells will be frozen and, later, cultured at the institute of human genetics in complete medium for 48 hours. the effect of the supernatants of these cultures on akt phosphorylation in hepg2 cells exposed to 10nm of insulin will then be quantified by two different techniques (western blot and elisa). this effect will be expressed as a percentage of inhibition compared to the phosphorylation of akt induced by insulin alone. the insulin slope between the measurement performed in the metactiv study and this iractiv study will also be calculated and compared to the peripheral blood mononuclear cells ability to induce insulin resistance in vitro.

Eligibility criteria:
inclusion criteria: * individuals who participated in the metactiv study. * profile 2 subgroup-specific inclusion criteria: * metactiv study individual with a profile 2. * persons who have given free informed consent. * persons who have signed the consent form. * persons affiliated to or benefiting from a health insurance plan. * adults (≥18 years of age). exclusion criteria: * persons participating in category 1 research involving human subjects * persons in an exclusion period as determined by another study. * persons under court protection, guardianship or trusteeship. * persons who are incapable of giving consent. * persons for whom it is impossible to give clear information. * pregnant, parturient or breastfeeding woman.

Keywords: insulin resistance
optimizing treatments for heart failure during hospitalization

Conditions: Decompensated Heart Failure

Summary: heart failure reaches 1.5 million people in france and is responsible for 200,000 hospitalizations per year. over the past ten years, new therapies have emerged (treatment of martial deficiency, entresto, isglt2). hospitalization in a context of acute heart failure is a moment of choice in the history of the disease to introduce recommended treatments under closer supervision (clinical, biological) than in ambulatory, and allows a decrease in hospitalizations, morbidity and mortality. the purpose of this study is to describe the introduction of heart failure drugs (including isglt2) in real-life settings in patients hospitalized for decompensated heart failure.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years * hospitalized (≥24h) for decompensated heart failure in cardiology. exclusion criteria: * patient opposition participation in research and use of data.

Keywords: decompensated heart failure
a modified calculation formula for meibomian gland grading

Conditions: Meibomian Gland Dysfunction

Summary: the meibomian gland (mg) is a modified sebaceous gland located in the upper and lower eyelids. the grades of mg loss (i.e. meiboscore) is calculated as the ratio between the area of the mgs and the eyelids, and this calculation is based on the two-dimensional digital infrared images.in the current formula, the area of the eyelid is the denominator. however, because the eyelids need to be flipped over for the examination and evaluation, and there may be interobserver variability in the measurement of the area of the eyelids. aging and involutional eyelid disorders, such as ptosis, ectropion, and entropion, may lead to laxity or deformation of eyelids, and impact the shape and area of eyelid area consequently.these factors could cause inaccuracy in current evaluation method, and impact the grading and evaluation of treatment efficacy of mgd, especially in self-controlled studies, such as in clinical trials. in this study, the investigators propose to use a modified calculation formula for the grading of mgs. the investigators could measure the white to white (wtw) distance of cornea, and then calculate the area of cornea (i.e. corneal base area) accordingly.unlike the eyelid, the wtw distance does not change significantly during aging or between sexes.thus, the investigators hypothesize that using the corneal base area as the new denominator in the formula for the grading of mg loss is a better way comparing with the conventional method.


Eligibility criteria:
inclusion criteria: * people aged 18 to 80 exclusion criteria: * exclusion criteria included contact lens wearer, history of eye surgeries, systemic health conditions affecting ocular health and those who were unable to cooperate with examinations.
a drug-drug interaction study to evaluate drug transporter interactions

Conditions: Hereditary Angioedema

Summary: this is an open-label, three part study to evaluate the effect of bcx7353 on drug transporters as well as the effect of an inhibitor of drug transport on bcx7353.

this is a single center, open-label, fixed-sequence, drug interaction study to evaluate the effect of bcx7353 on the pharmacokinetics of the p-gp substrate digoxin and the bcrp substrate rosuvastatin, as well as the effect of the p-gp inhibitor cyclosporine on the pharmacokinetics of bcx7353. it is planned that 54 subjects will be enrolled into 3 cohorts of 18 subjects each. cohort 1 will evaluate the effects of multiple doses of bcx7353 on single-dose pharmacokinetics of digoxin. cohort 2 will evaluate the effect of multiple doses of bcx7353 on the pharmacokinetics of rosuvastatin. cohort 3 will evaluate the effect of a single dose of cyclosporine on the pharmacokinetics of bcx7353. cohorts may be dosed in parallel or in any order.

Eligibility criteria:
key inclusion criteria: * written informed consent * acceptable birth control measures for male subjects and women of childbearing potential * creatinine clearance of at least 80 ml/min by cockcroft-gault equation * complies with all required study procedures and restrictions key exclusion criteria: * clinically significant medical history, current medical or psychiatric condition * clinically significant ecg finding, vital sign measurement or laboratory/urinalysis abnormality at screening or baseline * current use, or use of any prescribed or over the counter medication, vitamins or herbal products within 14 days of day 1 * use of medication that is known to inhibit or induce metabolic enzymes or transporters within 30 days of dosing * participation in any other investigational drug study within 90 days of screening * recent or current history of alcohol or drug abuse * regular recent use of tobacco or nicotine products * positive serology for hbv, hcv, or hiv * pregnant or nursing * donation or loss of greater than 400 ml of blood within the previous 3 months * history of severe hypersensitivity to any medicinal product * for subjects enrolled in cohort 1, current use of antibiotics or probiotics, or use within 6 months prior to day 1
sublingual methadone for the management of cancer-related procedure pain in inpatients

Conditions: Cancer; Pain

Summary: the purpose of this phase ii study is to determine the feasibility of the dose titration and assessment protocol in the impatient population, in the clinical setting of preventing or managing breakthrough pain, before conducting an appropriately powered phase iii study. thus the primary purpose of this study is to determine the proportion of patients who are successfully titrated to an effective dose of sublingual methadone.


Eligibility criteria:
inclusion criteria: * pain due to cancer or its treatment; controlled baseline pain; episodes of predictable, treatment related pain every day that are 4"/10" in severity or greater, last 10 minutes or longer, or episodes of breakthrough pain not related to cancer treatment, and are responsive to short acting oral opioids such as morphine or hydromorphone; are able to hold a volume of 1.0cc of water under tongue for a 2-minute period; are able to provide written informed consent; are able to fill out the study forms, and are inpatients exclusion criteria: * severe underlying respiratory disease such that the investigator is wary about the risk of respiratory failure from modest doses od opioid; prior sensitivity to methadone; currently are being administered methadone; are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely; and if they do not understand english sufficiently to provide written informed consent.

Keywords: sublingual methadone iatrogenic treatment related incident breakthrough pain feasibility study phase ii/open-label inpatients safety/efficacy cancer related breakthrough pain previously receiving opioids speak english