Kornimate/medical-research-clean huggingface dataset:
effect of a personalized sound intervention during autogenous gingival grafts in adults

Conditions: Music Intervention; Gingival Graft; Anxiety; Pain; Dissatisfaction

Summary: anxiety feeds the avoidance of dental treatments, leading to the neglect of general oral health. this avoidance is often amplified by the fear of potential pain and dissatisfaction after a dental appointment. a music listening intervention could be beneficial to reduce anxiety, pain and dissatisfaction. this intervention has the advantage to be non-invasive, cheap, and easy to implement in clinical settings. the objective of this study is to explore the effects of a personalised musical intervention on anxiety, pain and dissatisfaction associated with an autogenous gingival graft in comparison to the use of an audiobook (control). in this regard, three groups of patients will receive the gingival graft along with the personalized music intervention (n=20), an audiobook (n=20) or standard care (n=20). participants will be distributed randomly between conditions in a single blind design (surgeons will be unaware of the condition). however, since the third standard care control group was added as of 07-01-2023, all recruited participants will be enrolled in the standard care control group (non-randomized). self-reported measures of anxiety, pain, and dissatisfaction will be taken at different times (baseline, preoperative, postoperative, and follow-up).


Eligibility criteria:
inclusion criteria: * need a gingival graft that will not exceed 1.5 hour of surgery * understand spoken and written french or english * has the capacity to understand procedures and follow instructions * consent to follow instructions * consent to receive either the active or control sound condition * being 18 years or older exclusion criteria: * do not need a gingival graft * need a gingival graft that will last more than 1.5 hour of surgery * mental health or neurological disorders * auditory disorder * allergy or intolerance to nsaids
a study of ly3305677 in participants with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to learn more about the safety and side effects of ly3305677 when it is given as an injection just under the skin to participants with type 2 diabetes. the study will last about 20 weeks for each participant, not including screening.


Eligibility criteria:
inclusion criteria: * have type ii diabetes * body mass index (bmi) of 25-40 kilograms per square meter (kg/m²), inclusive * have a body weight of \<150 kilograms (kg) * have clinical lab test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator; however, should have serum magnesium and potassium levels, along with lactate dehydrogenase, ck values within the normal range at screening and day -2. exclusion criteria: * have type 1 diabetes or latent autoimmune diabetes in adults * have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization for 6 months prior to screening * have had an episode of severe hypoglycemia, defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, within 6 months prior to visit 1 * have an abnormal 12-lead electrocardiogram (ecg) at screening and/or day -2 that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ecg data analysis * have poorly controlled hypertension at screening; or a change in antihypertensive medication within 30 days of screening * have an estimated glomerular filtration rate \<45 milliliters per minute per 1.73 meters squared of body surface area (ml/min/1.73 m²)
szc versus sps for treatment of hyperkalemia in hemodialysis patients

Conditions: Hyperkalemia

Summary: this study aims to compare the effects of sodium zirconium cyclosilicate versus sodium polystyrene sulfonate for treatment of hyperkalemia in patients undergoing regular hemodialysis.

patients maintained on regular hemodialysis (hd) have a high risk of hyperkalemia (\>5.0 mmol/l). hyperkalemia is a critical medical condition that can result in arrhythmias and sudden cardiac death. treatment of hyperkalemia in hd patients is challenging. therapeutic options for the treatment of hyperkalemia in hd population include potassium binding resins, such as sodium polystyrene sulfonate (sps), patiromer, and sodium zirconium cyclosilicate. there is limited data about the use of these agents in hd.

Eligibility criteria:
inclusion criteria: 1. ≥3 month of maintenance hemodialysis, 3 times per week for 4 hours. 2. adult patients with age above 18 years. 3. baseline serum potassium level \>5 meq/l. exclusion criteria: 1. gastrointestinal diseases (constipation, bleeding, hx of endoscopy, chronic diarrhea or diarrhea in the past month, malabsorption, git surgery, ischemic colitis, necrosis, perforation, ....). 2. breast feeding or pregnancy. 3. patients who receive medications to treat hyperkalemia 2 weeks before study. 4. myocardial infarction, acute coronary syndrome, stroke, seizure, or thromboembolic event within 8 weeks before study.

Keywords: hyperkalemia hemodialysis sodium zirconium cyclosilicate sodium polystyrene sulfonate
telehealth virtual reality exergaming for spinal cord injury

Conditions: Spinal Cord Injuries

Summary: this pilot feasibility study aims to test whether youth and adults with spinal cord injury can use a group virtual reality gaming intervention to exercise. a second purpose is to examine whether there are potential benefits to cardiometabolic health and psychosocial health.

there are three purposes to this study. the first purpose is to quantify feasibility through telemonitored exercise data: total play time, moderate exercise time, playtime with others, and compliance to the data collections. these variables will be compared against a priori criteria for acceptability. these variables will help determine whether modifications to the intervention protocol are necessary. the second purpose is to qualitatively interview participants to explain underlying behavioral mechanisms that affect their participation in the program. this information will be used to explain how to improve implementation issues identified in aim 1. the third aim is to explore the potential effects of the program on self-reported psychosocial health and quality of life, hand-grip strength, and cardiometabolic health (blood cholesterol, lipids, pressure, and insulin) measured via home dried blood spot test.

Eligibility criteria:
inclusion criteria: * medical diagnosis of traumatic spinal cord injury (determined by international classification of disease \[icd\] codes) * a caregiver to support the participant if the participant is a child (\<18 years of age) * access to a wi-fi internet connection in the home exclusion criteria: * physically active (defined as \>150 minutes per week of moderate-to-vigorous intensity exercise in a typical week) * cannot use the arms for exercise or operate the controller buttons using their fingers * complete blindness or deafness * recent myocardial infarction or electrocardiography changes, complete heart block, acute congestive heart failure, unstable angina, and uncontrolled severe hypertension \[bp \>/= 180/110 mmhg\] * prone to seizures
prevalence and risk factors for micronutrient deficiencies during pregnancy in cayenne, french guiana

Conditions: Deficiency; Diet; Pregnancy

Summary: micronutrient deficiencies are frequent in pregnant women in french guiana, a french territory in south america. micronutrient deficiencies are more frequent in precarious women. obesity is a frequent problem but it is also associated with micronutrient deficiency. micronutrient deficiencies have largely been overlooked in this outermost european region and should be corrected.

involved in physical and brain development, immunity and metabolism, micronutrients have profound health effects. the nutritional status of pregnant women is a major determinant of fetal health. french guiana has a rapid population growth. social inequalities, cultural practices and gastrointestinal nematode infections in french guiana could affect the prevalence of these deficiencies. the main objective of the present study was to estimate the prevalence of micronutrient deficiency among pregnant women in french guiana. the secondary objective was to identify socio-demographic, dietary, obstetrical and neonatal risk factors associated with deficiencies. pregnant women over 22 weeks of pregnancy hospitalized for delivery at the obstetrical emergency department of the hospital center in cayenne from may 2018 to march 2019 were included. a socio-demographic and food questionnaire was administered. medical data were collected from the medical records. blood and urine samples were taken. the descriptive analysis used student and chi2 tests. a total of 341 women were included. the majority were born in haiti (39%) and french guiana (34%). at least one micronutrient deficiency was observed in 81% of women. precarious women had a significantly greater risk of micronutrient deficiency during pregnancy compared to those with both normal and complementary health insurance. micronutrient deficiencies in pregnant women in french guiana are a public health problem, a fact that was previously overlooked in a context of rising obesity. with over half of women overweight or obese and 81% with at least 1 micronutrient deficiency, balanced nutrition should be a major focus.

Eligibility criteria:
inclusion criteria: * pregnant at least 22 weeks of amenorrhea (who threshold for fetal viability) * patient hospitalized for delivery in the gynecological and obstetrical emergency unit at cayenne hospital * patient's consent * consent of the legal representative if the patient is a minor exclusion criteria: * refusalto participate in the study. * being under guardianship or curatorship * having been previously enrolled in the study

Keywords: micronutrients risks factors social inequalities
exercise training in depressed traumatic brain injury survivors

Conditions: Depression; Traumatic Brain Injury

Summary: the purpose of this study is to determine the feasibility of successfully delivering moderate intensity aerobic exercise training to depressed traumatic brain injury subjects between one and three years after injury.

traumatic brain injury (tbi) alters the lives of many civilians and those involved in armed conflicts. sequelae of tbi includes depression in up to 30% of cases. appearance of depression after tbi impairs recovery and results in sub-optimal re-integration into society. treatment of post tbi depression relies on oral medications, whose efficacy and side effect profile is sub-optimal. exercise training is effective in spontaneous depression as a stand alone treatment and in conjunction with oral medications, and this may represent an alternative treatment option in the tbi population. further, the pathophysiology of depression after tbi has yet to be examined with the full scientific rigor required. this project proposes to use exercise training of moderate intensity as a treatment for depression after tbi, while measuring biological markers as a way to investigate efficacy and provide insight into the pathophysiology.

Eligibility criteria:
inclusion criteria: * ct brain with subdural hematoma, subarachnoid hemorrhage, and/or cortical contusion * glasgow outcome scale extended of 4 to 8 * speaks english * beck depression inventory -ii score between 14 and 28 * sedentary life style * one to three years after traumatic brain injury exclusion criteria: * prior history of brain process (example, stroke, brain tumor) * aphasia * psychosis, mania, bipolar disorder, schizophrenia * pregnancy * inability to exercise via cycles or treadmill

Keywords: exercise depression traumatic brain injury
additive effect of probiotics (mutaflor®) in patients with ulcerative colitis on 5-asa treatment.

Conditions: Ulcerative Colitis

Summary: e.coli nissle 1917 (mutaflor®) is equivalent to mesalazine in preventing disease relapse in ulcerative colitis. however, data on ability of e.coli nissle 1917 (mutaflor®) to induce remission compared with placebo is limited. investigators aim to investigate the efficacy of e.coli nissle 1917 (mutaflor®) as an add-on treatment to 5-asa in mild to moderate ulcerative colitis.

this is a multicentre, double-blind, randomised, placebo-controlled study in patients with mild-to-moderate uc. subjects were randomly assigned to receive either e.coli nissle 1917 (mutaflor®) or placebo once daily for 8 weeks, and inflammatory bowel disease questionnaire (ibdq) scores, clinical remission, and response rate were compared.

Eligibility criteria:
inclusion criteria: * ulcerative colitis patients over the age of 19 with mild to moderate symptoms using 5-asa (mayo score 3-9) * patient who signed the consent form exclusion criteria: * the extent of ulcerative colitis is limited to proctitis * history of bowel resection * history of using other medication than 5-asa such as immunomodulators, steroid or biologics within 3months * history of using antibiotics or probiotics within 2 weeks * pregnant or lactating woman * requiring hospitalization and imminent need for surgery

Keywords: mutaflor
bariatric surgery during lockdown, impact of covid-19 on physical and mental health

Conditions: Obese; Morbid Obesity

Summary: from the beginning of march 2020, lockdown regimens prevented patients with obesity from receiving bariatric surgery. surgical emergencies and oncological procedures were the only operations allowed in public hospitals. consequently, patients with morbid obesity were put in a stand-by situation. with the aim at exploring physical and psychological conditions of the investigators future bariatric surgery patients, the investigators built a questionnaire concerning obesity and covid-19.

introduction: the investigators present an investigation about the impact of covid-19 on individuals suffering from severe obesity that were in the waiting list for bariatric surgery. worldwide and in italy bariatric procedures are considered as elective surgery and therefore were interrupted during the lockdown. the patients are well-known victim of stigma, social discrimination and the majority of them is affected by maladaptive eating behaviors that are supposed to worsen due to the isolation, absence of healthcare check-up and alarming pandemic scenario.the investigators performed telephonic interview providing an ad hoc questionnaire with the aim to explore their emotional and physical status. method: a total of 116 bariatric surgery candidates were approached using a telephonic interview during the italian lockdown.

Eligibility criteria:
inclusion criteria: * severe obesity with bmi \> 35 kg/m2 exclusion criteria: * alcoholism * drug addiction

Keywords: bariatric surgery covid-19 obesity mental health eating disorder
evaluation of loratadine for g-csf induced bone pain in patients with hematologic malignancies

Conditions: Leukemia; Lymphoma

Summary: the purpose of this project is to assess the efficacy of loratadine in decreasing the incidence and severity of bone pain following g-csf administration in patients with hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells, and patients who have undergone an autologous hematopoietic cell transplant. this is a different patient population than those being assessed in current clinical trials.

objectives the primary objective is to determine the incidence of bone pain following g-csf administration in patients with hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells, and patients who have undergone an autologous hematopoietic cell transplant. incidence will be determined via patient-reported incidence following g-csf administration. secondary objectives include determining the efficacy of loratadine for bone pain prevention as indicated by a decrease in incidence and a decrease in severity (questions 4 and 5 of the survey).

Eligibility criteria:
inclusion criteria: * receiving a g-csf after the institution practice change * receiving a g-csf for one of the following indications: * prevention/treatment of neutropenia along with treatment for leukemia or lymphoma * mobilization of hematopoietic progenitor cells * neutropenia prevention following autologous hematopoietic cell transplant * took loratadine per protocol with g-csf administration * completed a survey exclusion criteria: * taking daily antihistamines for allergies, asthma, or other indications, not including bone pain * taking daily nsaids, with the exception of aspirin, for chronic conditions * treatment for solid tumor cancers * receiving bone modifying agents for bone pain associated with metastatic disease or other chronic conditions
physical therapy in lipedema surgery

Conditions: Assessment; Lipedema; Vascular Diseases; Dermatologic Complication

Summary: the goal of this observational study or clinical trial is to know evaluate the effects of a modified complete decongestive therapy protocol using the godoy method in the postoperative period following lipedema surgery. the main question it aims to answer are: * if the treatment is effective on pain reduction, edema resorption, mobility improvement in short term and follow-up at 90 days * if the treatment is effective on preventing complications of these participants after surgery participants have been treated in the lasts years and authors recover information of the effects of the treatment. researchers will compare sub-groups of participants depending on the number of physical therapy sessions received

background: lipedema is an adipose tissue disorder in women, with an abnormal fat deposition in lower limbs and occasionally upper limbs. the patients present pain, bruising, heaviness, and mobility impairment. it affects them physically and psychologically. purpose: this study aims to evaluate the effects of a modified cdt protocol using the godoy method in the postoperative period following lipedema surgery. outcomes: pain (vas), edema resorption, complications, mobility and patient satisfaction. a descriptive statistical analysis will be performed using means and standard deviation (quantitative outcomes) and percentages (dichotomous and categorical outcomes). an inferential analysis will be carried out using paired and unpaired t-tests as one-way and repeated measures anova to search for differences between quantitative outcomes. pearson chi-square will also be used to relate dichotomous and categorical variables in a transversal analysis. all missing values will be excluded from the analysis. in all cases, a p\<0.05 value and a 95% confidence interval will be determined forstatistical significance. all statistical analysis will be performed using the stata® version 14.2 package for ms windows® version 10.

Eligibility criteria:
inclusion criteria: * female subject who underwent a lipedema surgery * recommendation of the surgeon to receive physical therapy exclusion criteria: * unilateral surgery * lack of data in the clinical history * only 1-2 physical therapy sessions

Keywords: lipedema, physical therapy,liposuction,complications,treatment,assessment
impact of antenatal corticosteroid therapy on postnatal surfactant use in preterm infants

Conditions: Hyaline Membrane Disease (HMD)

Summary: no study has shown that two doses of corticosteroids are more effective than a single dose in lung maturation and prevention of hyaline membrane disease (hmd) the aim of this study is to assess the impact of the number of doses on the severity of hmd.

respiratory distress syndrome (rds), formerly known as hyaline membrane disease, is a common problem in preterm infants. this disorder is caused primarily by deficiency of pulmonary surfactant in an immature lung. rds is a major cause of morbidity and mortality in preterm infants. surfactant therapy has been shown to significantly reduce neonatal and infant mortality. corticosteroids are given antenatal, and then surfactant is given, along with corticosteroids, postnatal. a single course of corticosteroids is recommended for pregnant women between 24 weeks and 34 weeks of gestation who are at risk of preterm delivery within 7 days, including those with ruptured membranes and multiple pregnancies. betamethasone is recommended as the steroid of choice, to be administered in two doses of 12 mg given intramuscularly 24 hours apart.

Eligibility criteria:
inclusion criteria: * preterm infants ≤ 37 sa * hospitalized in the neonatal intensive care unit between january 2018 and december 2019 * having received at least one dose of corticosteroids antenatal exclusion criteria: * parental opposition * congenital malformations that may cause neonatal respiratory distress.

Keywords: corticosteroid therapy surfactants preterm infants
identification of a predictive metabolic signature of response to immune checkpoint inhibitors in non-small cell lung carcinoma

Conditions: Non Small Cell Lung Cancer

Summary: immune checkpoints inhibitors (ici) are becoming new standards of care for non-small cell lung carcinoma (nsclc) treatment. to date, no powerful predictive biomarker of response has been found. the investigators hypothesize that metabolomics profile could represent a potent biomarker of response to ici

immune checkpoints inhibitors (ici) are becoming new standards of care for non-small cell lung carcinoma (nsclc) treatment, both as first and second line of treatment. to date, no powerful predictive biomarker of response has been found. it has been recently shown that microbiota composition could dictate the ability of patients to respond to ici. since, the microbiota produces circulating metabolites that will subsequently act on immune system, the investigators hypothesized that metabolic signature, reflecting microbiota function, could represent a predictive biomarker of response to ici. primary objective is to identify baseline metabolic signature (metabolomics analysis by mass spectrometry) associated to ici response. secondary objectives are to link metabolic signature with microbiota composition (metagenomics analysis rna 16s) and immune profile, and altogether with clinic response to ici. profile evolution (metabolic, metagenomics and immune) will be also analyzed at 2-month post ici initiation and at tumor progression, if any. in order to do so, the investigators thus plan to enroll 60 nsclc patients treated by ici as 1st, 2nd or 3rd line of treatment in chuga in 18 months. blood as well feces will be collected prior to, and at 2 month following ici treatment initiation as well as at progression. will be excluded from this study, patients that have received antibiotic or corticotherapy 2 or 4 weeks before ici initiation, respectively.

Eligibility criteria:
inclusion criteria: * nsclc diagnosis * patient treated by a ici in first, second or third line of treatment, or by the combination of chemotherapy and ipci in first line of treatment * patient with at least one measurable lesion as defined by recist exclusion criteria: * patient treated with antibiotic treatment within 2 weeks before the start of ici or corticosteroids (\>20 mg per day) within 4 weeks before the start of ici

Keywords: metabolomic microbiota
a 12 week study in patients with type 2 diabetes mellitus (t2dm)

Conditions: Type 2 Diabetes Mellitus

Summary: this study will assess the effect of lcq when added to metformin.


Eligibility criteria:
inclusion criteria: * hba1c from 7.0-10.0%, stable metformin dose exclusion criteria: * chf class iii-iv, liver disease other protocol-defined inclusion/exclusion criteria may apply

Keywords: type 2 diabetes