Kornimate/medical-research-clean huggingface dataset:
effect of exercise on hepatic fat in overweight children

Conditions: Non-alcoholic Fatty Liver Disease; Obesity; Metabolic Syndrome

Summary: the objective of the present study is to evaluate the effect of 6 months exercise intervention program on hepatic fat fraction in overweight children. methodology: a total of 160 children, 9-11 years old, will be randomly assigned to control (n=80) or intervention (n=80) groups. training sessions will include 90 minutes of exercise, comprising warm-up and skill development. the control group will attend a healthy lifestyle education program (2 days/month) and the intervention group an exercise (3 days/week) and healthy lifestyle education (2 days/month) combined program. before and after the intervention (6 months) hepatic fat fraction, body composition, , and cardiometabolic risk factors will be measured. furthermore, dietary habits and physical activity, blood pressure and pubertal development will be evaluated before and after the intervention.

the control group will attend a healthy lifestyle education program (2 days/month) and supportive therapy and behavioral advice for both children and parents to improve nutrition and physical activity (nutritionists and psychologists). the intervention group will attend an exercise (3 days/week) and healthy lifestyle education (2 days/month) combined program. training sessions will include 90 minutes of exercise, comprising warm-up and skill development, moderate to vigorous aerobic activities, flexibility and strength exercises. before (baseline) and after the intervention (6 months) total and abdominal adiposity, lean tissue mass and bone mass density (dual-x-ray-absorptiometry), abdominal visceral and hepatic adiposity (magnetic resonance imaging), and blood insulin, glucose, c-reactive protein, alanine aminotransferase, aspartate aminotransferase, gamma-glutamil transpeptidase and lipid profile will be measured. furthermore, cardiorespiratory fitness (treadmill test) and blood pressure will be measured before and after the intervention. changes (6 months - baseline) in dietary habits will be estimated by using two repeated 24h recalls and food frequency questionnaires and changes (6 months - baseline) in physical activity by accelerometry.

Eligibility criteria:
inclusion criteria: * overweight or obesity status * 9-11 years old exclusion criteria: * medical conditions that hamper their participation in the exercise program * secondary obesity

Keywords: overweight children hepatic fat exercise nutritional education program cardiometabolic risk
a study of nalbuphine (extended release) er in idiopathic pulmonary fibrosis (ipf) for treatment of cough

Conditions: Idiopathic Pulmonary Fibrosis

Summary: to evaluate the safety and tolerability of nalbuphine er tablets in the study population and to evaluate the effect of nal er tablets on the mean daytime cough frequency (coughs per hour) at day 22 (dose 162 mg bid) as compared to placebo tablets.


Eligibility criteria:
inclusion criteria: 1. individuals diagnosed with idiopathic pulmonary fibrosis 2. chronic cough \> 8 weeks. 3. daytime cough severity score ≥ 4 on cough severity numerical rating scale at screening. exclusion criteria: 1. the following conditions are excluded: 1. interstitial lung disease (ild) known to be caused by domestic and occupational environmental exposures. 2. interstitial lung disease (ild) known to be caused by connective tissue disease. 3. interstitial lung disease (ild) known to be caused by drug related toxicity. 2. currently on continuous oxygen therapy. 3. history of substance abuse that, as determined by the investigator, may interfere with the conduct of the study.

Keywords: nalbuphine cough idiopathic pulmonary fibrosis pharmacokinetics
luteal-phase gnrh agonist administration in frozen-thawed ivf embryo transfer cycles

Conditions: Pregnancy Rate

Summary: supraphysiological hormonal stimulation enables collecting many oocytes in an in-vitro fertilization treatment, but may have a negative effect on uterine function and contribute the fact that the majority of preembryos placed in the uterus fail to implant. several medical agents were shown to be beneficial when given in the luteal phase of an ivf cycle, but the optimal regimen has not been yet determined. in 2006, a european group reported that addition of gnrh analog (decapeptyl) as luteal support in ivf cycle significantly improved pregnancy and delivery rates. it is not known whether this positive effect influences the corpus luteum, embryo or the uterus. the researchers sought to evaluate the effect of gnrh administration as luteal support in frozen-thaws ivf cycle.


Eligibility criteria:
inclusion criteria: ivf patients transfer of a minimum of two medium-quality thawed embryos in ivf exclusion criteria: 1. two or more fresh ivf embryo transfer or three or more thawed embryos transfer with no pregnancy. 2. maximal endometrial thickness \< 6 mm or intracavitary fluid at the time of embryo transfer on previous cycles 3. untreated hydrosalpinges 4. intracavitary mass 5. submucous myoma 6. known allergy to one of medical agents used in the study

Keywords: gnrh analog, ivf, infertility, frozen-thawed embryos
study on autologous osteoblastic cells implantation in hypotrophic non-union fractures

Conditions: Long Bone Non-Union

Summary: fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone (gerstenfeld et al., 2003). depending on fracture site, complexity, co-morbidities and other factors, 10% of all fractures will eventually fail to unite. non-union fractures are defined as fractures that are at least six to nine months old and in which there have been no signs of healing for the last three months. various causes have been evoked for impaired healing in hypotrophic (atrophic and oligotrophic) non-unions, including poor fracture stabilization, local infection and failure of the osteoblastic cells to multiply. currently the treatment of choice for non-unions, particularly atrophic non-unions, is bone autograft (or allograft), combined or not with intramedullary nailing, plating, and external fixation devices (kanakaris et al., 2007). this procedure produces good results but requires an invasive surgery of several hours under general anesthesia and a few days of hospitalization. because of this, major complications have been reported in up to 20-30% of patients (pieske et al., 2009, zimmerman et al., 2009). this phase 2b/3 study aims at demonstrating the safety and efficacy of preob®, a proprietary population of autologous osteoblastic cells, in the treatment of hypotrophic non-union fractures of long bones. preob® will be compared to bone autograft in a non-inferiority design.


Eligibility criteria:
inclusion criteria: * ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements * diagnosis of a non-infected hypotrophic non-union fracture of a long bone of at least 6 months at the time of treatment * normal hematology function exclusion criteria: * positive serology for hiv, hepatitis b, hepatitis c, syphilis, htlv-1 * presence or previous history, or risk factors for diseases caused by prions * renal impairment, hepatic impairment * patient with poorly controlled diabetes mellitus, severe arterial diseases and/or neuropathy * insufficient fracture stability * recent osteosynthesis material or bone graft * multifocal fracture/non-unions

Keywords: non-union fractures impaired healing fractures orthopedics bone musculoskeletal disorders
nebulized aztreonam for prevention of gram negative ventilator-associated pneumonia

Conditions: Ventilator Associated Pneumonia; Prevention; Respiratory Infection Other

Summary: aerosol antibiotic administration offers the theoretical advantages of achieving high drug concentration at the infection site and low systemic absorption, thereby avoiding toxicity. antibiotic aerosolization has good results in patients with cystic fibrosis, but data are scarce for patients under mechanical ventilation. prospective, randomized 1:1, open-label study to assess the microbiological cure and pharmacokinetics (pk), safety and efficacy of nebulized aztreonam lysine (75 mg dose) each 8 hr during 5 days in ventilated patients heavily colonized by gram-negative bacteria. it is planned to include a total of 20 ventilated patients heavily colonized. only ten of them (active group) will receive 5 days of treatment with nebulized azli.the control group will not receive treatment.

the main objectives of this study is: to compare the microbiological cure at day 5 of treatment and the incidence of gram-negative ivac between 7th and 10th days after last dose in patients heavily colonized by gram-negative bacteria treated with nebulized azli vs. no treatment. the secundary objective of this study are: 1. safety and tolerability of azli administered during 5 days in adults patients under mechanical ventilation heavily colonized by gram-negative bacteria 2. the pharmacokinetic profile in endotracheal aspirate (ea) or bronchoalveolar lavage (bal). 3. the plasma levels of nebulized azli in patients under mechanical ventilation heavily colonized by gram-negative bacteria.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. patients under mechanical ventilation for more than 5 day. 3. patient with heavy colonization by gram-negative microorganisms. 4. no clinical suspicion of infections-related ventilator-associated complications (ivac) according cdc criteria (figure 1). 5. patients or his/her legal representative with ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments. 6. informed consent signed exclusion criteria: 1. suspected of ivac. 2. patients with known hypersensitivity to aztreonam. 3. patients who received more than 48 hours of broad spectrum antibiotics. 4. evidence of active mycobacterium infections, chronic pulmonary infection or bronchial obstruction. 5. granulomatous disease, lung cancer or lung transplant. 6. acute respiratory distress syndrome (ards) 7. woman who is pregnant or breast-feeding while enrolled in this study. 8. any medical condition which, in the opinion of the investigator, places the patient at an unacceptable risk for toxicities if entered into the clinical study

Keywords: nebulized antibiotic ventilator associated pneumonia ventilated associated tracheobronchitis aztreonam lysine
moisture chamber glasses for dry eye in asian population

Conditions: Dry Eye

Summary: objective of this study is to evaluate the tolerance and potential benefit of moisture chamber glasses for dry eye in an asian population. in this clinic based prospective interventional study, we aim to recruit patients (until 10 patients complete the study) who have evaporative dry eye due to exposure to environmental stress (such as frequency of out door activities) and keen to try out moisture chamber glasses/ eyewear from the dry eye clinic in singapore national centre. after informed consent, these patients will be prescribed 7eye( panoptx)™ moisture chamber glasses/eyewear for 3 months and will be monitored on a diary for the amount of time wearing eyewear for 2 weeks and the number of eye drops for each type of medication used. other outcomes will be changes in symptoms of dry eye using visual analog scale, as well as objective signs of dry eye (eg. corneal fluorescence staining and tear break up time (tbut). as moisture chamber spectacles are currently not available as a treatment option for dry eye in singapore, the findings of this study will give an insight to the efficacy of this new treatment modality in our population.


Eligibility criteria:
inclusion criteria: 1. subjects with evaporative dry eye as assessed by the pi in the dry eye clinic and has occupational or lifestyle requirement to be exposed to a hyper-evaporative environment. exclusion criteria: 1. subjects who can't wear the eye wear as instructed in the study, or unable to complete the diary of eye wear use. 2. subjects with eye lid or facial bone malformation 3. subjects with a significant refractive error that warrants spectacles with a refractive power.
a case-control study to assess the association between environmental, domestic and occupational exposures and the risk of testicular germ cell tumor

Conditions: Testicular Germ Cell Tumor

Summary: the incidence of testicular germ cell tumors, the most common cancer in men aged 15 to 45 years, has doubled in france in 30 years. reasons remain unclear but a role of environmental factors, especially during critical periods of development, is strongly suspected. reliable data on environmental exposure during this critical period are sparse.the discordant findings and the limitations of available studies underline the importance to conduct studies with sufficient statistical power to detect risk due to exposures during critical windows of vulnerability. we conduct a multicentric case-control study to assess this association. cases and controls will be enrolled during a 18-month period. they will be interviewed by professional telephone interviewers about their occupational and residential history and about their domestic exposure to pesticides and other nuisances. an optional biological study to assess genetic polymorphisms known to be associated with testicular cancer will be proposed to every cases and controls. mothers (or close relative) of cases and controls will also be contacted (with son's agreement). if they agree to participate, they will also be interviewed about antenatal and early life exposure of their sons to pesticides and other nuisances. cases will be matched up with 2 controls (one of each group) both on age (+/- 2 years) and on recruiting center.

environmental exposure to pesticides will be assessed from subject's residential history, using a geographic information system. occupational exposure to pesticides and other nuisances will be assessed by an industrial hygienist who will be in charge to encode all subjects and mothers' occupations. domestic exposure to pesticides will be assessed from type, target and frequency of domestic pesticide use. based on these 3 sources of exposure, a score of exposition will be calculated for each case and each control.

Eligibility criteria:
inclusion criteria: * men aged between 18 and 44 years old * born in metropolitan france * able to understand, read and write french * without any psychiatric and severe cognitive disorder * willingness to participate to the study * who has signed and dated an inform consent form * affiliated to a health care system exclusion criteria: * who has a legal guardian * history of testicular germ cell tumor or cryptorchidism (only for controls)
registry for hf20 for pediatric crrt under emergency use authorization

Conditions: Pediatric Kidney Disease; Acute Kidney Injury

Summary: historically, innovations for acute kidney injury (aki) and continuous renal replacement therapy (crrt) have centered around an adult population. however, research has shown that over 10% of pediatric patients develop severe aki within the first week in an intensive care unit (icu). when a pediatric patient requires renal replacement therapy for aki in the icu, crrt is usually the modality of choice. the hf20™ is indicated for supporting patients weighing 8 to 20 kilograms, addressing a critical clinical need for critically ill children who require crrt. current us food and drug administration (fda) approved crrt filters are designed for patients weighing more than 20 kg or less than 10 kg, leaving a gap in appropriately designed filters for pediatric patients. a previous trial in the us showed that the hf20™ is safe and effective, however the membrane composition of the hf20™ used in that trial is different than what is currently manufacturer and available. baxter healthcare corporation has received an emergency use authorization (eua) for the currently available hf20™ to be used in the era of the covid-19 pandemic, however participants do not need to be infected with the sar-cov-2 virus in order to be treated. the eua for the hf20™ allows for treatment for any children weighing between 8 and 20 kilograms in need of crrt. this registry will collect clinical data related to the safety and efficacy of the hf20™ filter for crrt in pediatric patients weighing 8 to 20 kilograms at participating institutions, however participation in this registry is not a requirement in order to be treated with the hf20™ filter.


Eligibility criteria:
inclusion criteria: * receiving or plan to receive crrt with the hf20™ filter as standard of care * acute kidney injury (aki) or fluid overload as defined as one of the two below: 1. aki defined as kidney disease improving global outcomes (kdigo) stage 1 or higher by either: 1. serum creatinine criteria (0.3 mg/dl increase over baseline in 48 hours, or a 50 percent increase within the previous 7 days) or 2. urine output criteria (less than 0.5 ml/kg/hr for 6 or more hours) 2. severe fluid overload defined as greater than 10 percent fluid accumulation based on icu admission weight exclusion criteria: * weight less than 8 kilograms * weight more than 20 kilograms * patient not expected to survive more than 48 hours * received renal replacement therapy in the previous 5 days

Keywords: hf20
evaluating the use of two different needles in subjects with diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems

Summary: this trial is conducted in europe. the aim of this trial is to compare two needle types when used with a disposable insulin injection pen in the everyday life setting of an insulin treated patient with diabetes.


Eligibility criteria:
inclusion criteria: * signed and dated informed consent obtained before any trial-related activities * diagnosed type 1 or type 2 diabetes * treated with insulin exclusion criteria: * previous participation in this trial * mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation * any disease or condition which the investigator feels would interfere with the trial
prediction of appearance of late cutaneous side effects after radiotherapy

Conditions: Merkel Carcinoma; Radiotherapy Side Effect

Summary: search for blood predictive marker (s) for cutaneous radiosensitivity


Eligibility criteria:
inclusion criteria: * patient treated with surgery and radiotherapy (rt) for histologically proven merkel carcinoma * previous radiotherapy treatment completed for at least 6 months * absence of prior treatment by chemotherapy or hormonotherapy * patient over 18 years of age * patient affiliated to a social security system * informed consent signed exclusion criteria: * presence of another evolutionary cancer * re-irradiation in the same area * absence of available dosimetry data * patient under guardianship or curatorship or safeguard of justice
arithmetic abilities in children with 22q11.2ds

Conditions: 22q11.2 Deletion Syndrome

Summary: the study arith22 will investigate the role of visuo-spatial attention on arithmetic abilities of children with 22q11.2 deletion syndrome.

children with 22q11.2 deletion syndrome often have arithmetic learning disability because of magnitude representation impairment. previous works suggested that magnitude representation impairment could be a result of endogenous visuo-spatial attention dysfunction in 22q11.2ds. nevertheless this relationship is still poor explored. the influence of visuo-spatial abilities on arithmetic achievement could also be modulated by developmental age. the study arith22 will test these hypotheses thanks to magnitude comparisons tasks, in children with 22q11.2 deletion syndrome and matched children without developmental disease.

Eligibility criteria:
inclusion criteria: * diagnosis of 22q11.2 deletion syndrome or no developmental disease * aged from 4 to 11 years old * french language exclusion criteria: * diagnosis of intellectual deficiency according to dsm 5 criteria * drug prescribed for somatic condition that could influence cerebral functioning

Keywords: 22q11.2 deletion syndrome arithmetic magnitude representation children
electrostimulation protocol incontinence

Conditions: Female Stress Incontinence

Summary: to verify the effect of an adapted electrostimulation (ee) protocol for stress and mixed urinary incontinence (sui / m) and its impact on quality of life (qol)

controlled and randomized clinical trial performed at the physiotherapy outpatient clinic at the magalhães neto pavilion of comhupes / ufba. women aged between 30 and 65 years and diagnosis of sui / ium. the patients were allocated to two groups (ga) submitted to selective electrostimulation for tonic fiber, phasic fibers iia / iib and different times of electrical stimulation; (gb) used 50hz for all fibers by 20mm, both answered the questionnaire king's health questionnaire (khq).

Eligibility criteria:
inclusion criteria: * women between the ages of 30 and 65 * with diagnosis of stress urinary incontinence and / or mixed * perineal muscle weakness * accepted to sign the tcle exclusion criteria: * women with neurological changes * pregnant women * iud use * pacemaker * genitourinary tract infection * cancer * refuse to sign the tcle