Kornimate/medical-research-clean huggingface dataset:
bioequivalence/food effect - saxa/dapa dual fixed dose combination (fdc)

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to demonstrate the bioequivalence (be) of saxagliptin and dapagliflozin from a 2.5-mg saxagliptin/5-mg dapagliflozin fdc tablet after oral administration relative to 2.5-mg saxagliptin and 5-mg dapagliflozin tablets administered orally together in the fasted state and to demonstrate the be of saxagliptin and dapagliflozin from a 5-mg saxagliptin/10-mg dapagliflozin fdc tablet after oral administration relative to 5-mg saxagliptin and 10-mg dapagliflozin tablets administered orally together in the fasted state. demonstrating bioequivalence refers to showing that the fdc tablet and co-administration of the individual components yield similar blood levels/concentrations of the drug and are handled by the body similarly.

primary purpose: this study is designed to demonstrate the bioequivalence of saxagliptin and dapagliflozin from a fdc tablet after oral administration relative to saxagliptin and dapagliflozin tablets administered orally together in the fasted and fed state

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination (pe), vital signs, 12-lead ecg, and clinical laboratory determinations * body mass index (bmi) of 18.5 to 30 kg/m(2) * men and women, ages 18 to 50 years * women of childbearing potential must use acceptable methods of highly effective birth control exclusion criteria: * any significant acute or chronic medical illness * current or recent gastrointestinal disease * any major surgery within 4 weeks of study drug administration * history of chronic or recurrent urinary tract infection for females * history of glucose intolerance or diabetes mellitus * history of allergies or adverse reactions to dipeptidyl peptidase-iv (dpp4) or sodium-glucose cotransporter (sglt) inhibitors * prior exposure to saxagliptin or dapagliflozin or related drugs
avdoralimab an anti-c5ar antibody, in patients with covid-19 severe pneumonia ( force )

Conditions: COVID

Summary: the primary objective of this trial is to improve the proportion of covid-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with covid-19 pneumonia complicated by acute respiratory distress syndrome (ards).


Eligibility criteria:
inclusion criteria: * covid-19 severe pneumonia patients need for oxygen therapy ≥ 5 l/min or high-flow oxygen therapy * covid-19 related acute respiratory distress syndrome (ards) requiring mechanical ventilation exclusion criteria: * pregnant woman * uncontrolled sepsis of bacterial or fungal origin
aurolab hydrophobic foldable intraocular lens study

Conditions: Cataract

Summary: the purpose of this study is to evaluate whether hydrophobic intraocular lenses manufactured by aurolab are safe and effective in the surgical treatment of cataract.

hydrophobic as the name suggests is fear for water. hydrophobic foldable iols are made from acrylic material. aurolab has developed its own hydrophobic acrylic material. this material has been subjected to several biocompatibility studies and it has proved itself to be biocompatible.

Eligibility criteria:
inclusion criteria: * age 40 to 65 years * senile cataract * posterior subcapsular cataract (pscc) exclusion criteria: * obviously debilitated patients * cardiac and other serious illness * diabetic patients * traumatic cataract * complicated cataract * congenital cataract * drug induced cataract * shallow anterior chamber * poor mydriasis * amblyopia * pseudo exfoliation (pxf) * dense posterior polar cataract (ppc) * one eyed patients * glaucoma * uveitis * corneal pathology * retinal pathology * intra operative complications like pc rupture, zonular dialysis

Keywords: lenses, intraocular prospective studies visual acuity clinical trial
conceptt kids international neurodevelopmental outcomes among offspring of women with type 1 diabetes

Conditions: Neurocognitive Disorders

Summary: neurodevelopmental outcomes among offspring of women with type 1 diabetes: a follow up study of the conceptt randomized control trial (conceptt kids international). an international, multicentre prospective cohort study of child and mother pairs. the potential number of recruits is 225 and the main inclusion criteria is child's mother who participated in the conceptt trial.

this is a multicentre, international prospective cohort study of child and mother pairs from sites in canada, uk, spain and italy. the expected duration of the study is three years. women who participated in conceptt will be invited to participate in conceptt kids international. once informed consent is obtained, mothers will be asked to complete forms and questionnaires that provide information on family socio-demographics and their children's executive functions and behaviour (i.e. social responsiveness and attention). self-reported height and weight measures of the child and parent(s) will also be collected. our primary outcome measure is childhood executive function measured by the global executive composite of the behaviour rating inventory of executive function - second edition (brief2) the secondary outcome measures were chosen based on our systematic review and meta-analysis, which identified significant associations between maternal pre-existing diabetes, and asd and adhd. we will use two parent-completed questionnaires to assess symptoms associated with these disorders; the social responsiveness scale-2 (srs-2) for behaviours associated with asd and the adhd rating scale-5 (adhd-5) for adhd symptoms.

Eligibility criteria:
inclusion criteria: * children of women who participated in the conceptt trial at selected recruiting sites exclusion criteria: * na
retrospective study of patients with severe aplastic anemia who developed high risk clonal evolution with chromosome 7 abnormalities after immunosuppressive therapy

Conditions: Severe Aplastic Anemia

Summary: background: severe aplastic anemia (saa) is a form of bone marrow failure. it usually results from a cytotoxic t cell attack on the marrow stem cell. two treatments can be used for saa. one is allogeneic hematopoietic stem cell transplant (hsct). the other is immunosuppressive treatment (ist). in most cases, hsct or ist works. but for some people, clonal evolution occurs after ist. one of the most common forms of clonal evolution is chromosome 7 abnormalities. these have a poor prognosis. hsct can be used to treat them. researchers do not know why clonal evolution happens. they want to look at data from past studies to learn more. objective: to compare the data of people with saa who developed chromosome 7 abnormalities between those who ultimately received hsct versus those who received chemotherapy alone or supportive care. eligibility: adults and children with saa who were enrolled on nhlbi protocol 12-h-0150, 06-h-0034, 03-h-0249, 03-h-0193, 00-h-0032, or 90-h-0146 design: this study uses data from past studies. the participants in those studies have allowed their data to be used in future research. researchers will review participants medical records. they will collect clinical data, such as notes, test results, and imaging scans. they will also collect the research data gathered as part of the original study. researchers will enter the data into an in-house database. it is password protected. all data will be kept in secure network drives or in sites that comply with nih security rules. other studies may be added in the future.

severe aplastic anemia (saa) is a form of bone marrow failure in most cases is the result of a cytotoxic t cell attack on the marrow stem cell. it is effectively treated in most patients with either immunosuppressive treatment (ist) or allogeneic hematopoietic stem cell transplant (hsct). however, after ist, 'clonal evolution' is a significant complication in about 15% of patients, presenting as either a new cytogenetic abnormality or morphological evidence of myeloid malignancy. in particular, the development of chromosome 7 abnormalities is considered high risk and is associated with poor prognosis. the optimal treatment of chromosome 7 abnormalities following saa is not defined though hsct is widely offered.

Eligibility criteria:
* subjects will not be recruited for this study. this is a retrospective chart review. patients who opted out of future use of data on their prior studies will be excluded from this study.

Keywords: cytogenic abnormality natural history
an intervention for eating and body image concerns among young adult women

Conditions: Eating Disorder Symptom; Body Image Disturbance

Summary: the primary aim of the current study is to assess acceptability and feasibility of online body image exposure and self-compassion interventions before conducting a larger rct.

this study will determine the feasibility and effectiveness of delivering an online therapy for eating pathology and body image disturbance. it will address body image and eating pathology in a non-clinical group of young adult women, who are at risk of developing such problems . the feasibility study will determine whether there are any difficulties that would need to be addressed in recruitment, online delivery and assessment of those treatments.

Eligibility criteria:
inclusion criteria: * body shape questionnaire score \> 25 * age ≥18 * self-identified women * be able to use a computer and having an internet connection and webcam exclusion criteria: * insufficient knowledge of english * learning disability, severe mental illness or alcohol/substance dependence, history of self-injuries, current eating disorder, current clinical depression * psychiatric illness requiring secondary care intervention * male * under 18 years old * body mass index below 18.5 * currently undergoing psychological therapies * no access to a tablet or computer with an internet connection

Keywords: eating pathology body image exposure self-compassion
psychological treatments for scleroderma

Conditions: Pain; Depression; Scleroderma; Systemic Sclerosis

Summary: this study will examine the effectiveness of two psychological treatment approaches designed to help people who have scleroderma with three important areas of daily living: pain, depression, and distress about changes in appearance. the study will also evaluate the impact of depression on the two psychological treatments. because psychological approaches requiring a trained professional can be expensive and are often not available to most patients, this study will also look at the effectiveness of a self-help treatment approach.

this study will examine the efficacy of psychological interventions designed to target important areas of daily living for people with scleroderma: pain, depression, and distress about disfigurement. the study will also examine the effect of clinical depression on impact of the psychological treatments. because psychological interventions requiring a trained professional can be costly and are often not available to the majority of patients, the study will also examine the efficacy of a self-help intervention. the study will recruit 201 patients with systemic sclerosis who report symptoms of pain, depression, or distress about disfigurement and will randomly assign them to one of three interventions: individual cognitive behavioral therapy, self-help cognitive behavioral intervention facilitated by a psychologist, or a disease/health education intervention. an individual blinded to intervention assignment will collect measures of pain, functioning, distress about disfigurement, and mood at baseline and following the 8-week intervention period. both the cognitive-behavioral self-help materials and the educational materials (eight written chapters and audiotapes) will be designed for home use but will be supplemented by two individual sessions and two telephone contacts with the professional. patients will be followed for 1 year after completing the active intervention phase. these findings will increase understanding of the quality of life of individuals with scleroderma and determine whether self-help interventions can be used effectively to manage pain, depression, and distress about disfigurement.

Eligibility criteria:
inclusion criteria: * diagnosis of crest or systemic sclerosis * short-form mcgill pain questionnaire score 6 or higher * satisfaction with appearance score of 15 or higher * beck depression score of 10 or higher exclusion criteria: * patients reporting severe depression with suicidal ideation * delirium, dementia, or cognitive impairment (mini mental state examination (mmse) \< 24)) * terminal illness with a life expectancy of less than 1 year

Keywords: scleroderma systemic sclerosis depression pain disfigurement body image dissatisfaction cognitive-behavioral therapy self-help psychological intervention
focus-out glasses on emmetropization in chinese children

Conditions: Emmetropization; Myopia; Hyperopia

Summary: the purpose of this study is to characterize the effects of peripheral focous-out glasses on emmetropization in non-myopic chinese children aged 6-8 years.this is a prospective, parallel-controlled randomized trial.

myopia is one of the most common eye diseases that cause visual impairment and blindness, and the high rate of myopia in young people is a major public health issue. based on the clinical studies of optical defocusing to regulate eye growth and refractive changes through visual signal feedback, we hypothesize that early wearing of peripheral defocus glasses in children can slow down the process of emmetropization and even prevent the onset of myopia by producing more myopic defocusing. the aim of this study is to investigate whether wearing peripheral defocus glasses can effectively delay emmetropization in non-myopic children aged 6-8 years , and to further explore its effect on preventing the onset of myopia. the study adopts a 2-year，single-centre, randomized, parallel-controlled trial with a non-blinded design. subjects who pass the screening period will have their baseline data collected and will be assigned to the experimental or control groups according to the randomization principle. the experimental group will be fitted with direct emmetropia with focus-out glasses (hereafter referred to as defog) to guide the emmetropization process. the control group will be given no treatment and will be a blank control. baseline data including visual acuity, cycloplegic objective refraction, axis length, accommodation amplitude, strabismus examination, pupil size, choroidal thickness and peripheral retinal refraction will be measured when enrolled in the group and follow-up data will be measured at month 6, 12, 18 and 24. the primary interest of this study will be studied by comparing the difference in cycloplegic objective refraction changes between month 24 and baseline in the two groups of subjects.

Eligibility criteria:
inclusion criteria: 1. age: ≥6 and ≤8 years at enrollment. 2. at least one parent' s spherical equivalent refraction≤-3.00d. 3. spherical equivalent refractions (sers) under cycloplegia: +0.50 to +1.50 diopters (d) 4. astigmatism ≤1.00 d . 5. anisometropia ≤1.00 d. 6. best corrected visual acuity (bcva) : 1.0 or better 7. provision of consent written by subject's legal guardian 8. willing and able to participate in all required activities of the study exclusion criteria: 1. any of the following abnormalities on the ocular surface, such as trachoma, pemphigoid, chemical injury, heat burn, radiation injury, etc. 2. eyelid abnormalities (e.g. entropion, ectropion, tumor, edema, blepharospasm, incomplete eyelid closure, severe trichiasis, severe ptosis) ,which affect eyelid function in either eye 3. eye diseases such as strabismus, amblyopia, anisometropia, fundus diseases, and accommodation abnormality，etc. 4. prior treatment of myopia control in either eye, including but not limited to drugs, orthokeratology, low-level red-light therapy, etc. 5. noncompliance with measurement at enrollment.
observational study of prosthetic tissue aortic and mitral heart valve

Conditions: Valvular Heart Disease

Summary: this study is a multi-center, prospective, non-randomized, observational study. the objectives of this study are to confirm the clinical safety and efficacy of the sjm epic valve.

this study is a multi-centered, multi-country, prospective, non-randomized, observational study, without concurrent or matched controls, conducted under a common protocol. bayesian methods will be used for the design and analysis of this study. the bayesian model will determine if the data for the valve configurations are poolable. bayesian methods also provide a means of determining the appropriate stopping time for the study based on the amount of information generated. the objectives of this study are to confirm the clinical safety and efficacy of the sjm epic valve by establishing the following: * adverse effect rates * clinical status as indicated by nyha functional classification * hemodynamic performance

Eligibility criteria:
inclusion criteria: * the patient requires replacement of the aortic and/or mitral valve (note: patients undergoing concomitant procedures, e.g. coronary artery bypass grafting, valve repair, are eligible for this study). * the patient (or legal guardian) has signed a study-specific informed consent, agreeing to the data collection and follow-up requirements. * the patient is of legal age in host country. exclusion criteria: * patient already has a prosthetic valve, other than the aortic and/or mitral valve being replaced at this time. * the patient requires replacement of the tricuspid or pulmonary valve. * the patient is pregnant or nursing. * patient has active endocarditis. * patient is actively participating in the study of an investigational drug or device. * patient has had an acute preoperative neurological event. * the patient is undergoing renal dialysis. * patient is an intravenous drug abuser, alcohol abuser or prison inmate. * patient has an inability or unwillingness to return for the required follow-up intervals. * the patient had the sjm epic valve implanted during the clinical study but then had the bioprosthesis explanted.

Keywords: heart valve mitral aortic valvular disease
nf-1, nutraceutical intervention

Conditions: Neurofibromatosis 1

Summary: the treatment plan is identical for all participants with the exception of the curcumin dose level that is assigned at study enrollment. participants are instructed to take the curcumin and olive oil one after the other (order does not matter) twice a day on an empty stomach ideally 30 minutes before breakfast and dinner. curcumin and high phenolic extra virgin olive oil (hp-evoo) may continue for up to 12 months in the absence of unacceptable side effects.


Eligibility criteria:
inclusion criteria: * nf1 diagnosis based on nih consensus conference criteria and/or genetic testing * measurable cutaneous neurofibromas (cnfs) with or without plexiform nf * aged 18 years or older at the time of written consent * voluntary signed written consent obtained before the performance of any study-related procedure not part of normal medical care exclusion criteria: * concurrent treatment with selumetinib or other mapk, mek or mtor inhibitors, other targeted therapies, chemotherapy or radiation * conditions requiring systemic immunosuppression * swallowing difficulties or strong gag reflex which may interfere with study compliance * any comorbidities that may affect study participation in the judgement of enrolling investigator * psychiatric illness, cognitive challenges, social situations, or other circumstances that would limit compliance with study requirements, per judgment of the enrolling investigator * treatment with high phenolic olive oil or curcumin within six months of study entry * known pregnancy or anticipated conception during the 1 year study period
phase i study of human von willebrand factor for von willebrand's disease

Conditions: Von Willebrand's Disease

Summary: objectives: i. evaluate the effect of a new von willebrand factor concentrate on bleeding time, in vivo recovery, and circulating half-life of the infused factor in patients with von willebrand's disease. ii. assess the safety of von willebrand factor in these patients.

protocol outline: patients receive 1 dose of von willebrand factor concentrate. timed blood studies are performed for the next 96 hours. patients are followed every 2 weeks for 16 weeks, and at 24, 36, and 52 weeks.

Eligibility criteria:
protocol entry criteria: * von willebrand's disease

Keywords: hematologic disorders rare disease von willebrand's disease
safety and efficacy of gadobutrol 1.0 molar ( gadavist ) in patients for central nervous system (cns) imaging

Conditions: Central Nervous System Diseases

Summary: this is a study involving the use of magnetic resonance imaging (mri) contrast agents called gadavist. the purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadavist when used for taking images of the brain and spine. the results of the mri will be compared to the results of images taken without gadavist.

issues on safety will be addressed in adverse events section.

Eligibility criteria:
inclusion criteria: * patients referred for contrast enhanced mri of the cns based on symptoms or previous procedures. exclusion criteria: * patients with acute renal insufficiency * patients with severe renal disease * patients with any contraindication to magnetic resonance imaging.

Keywords: central nervous system imaging diagnostic imaging
three-dimensional perception of sounds in military with acoustic trauma

Conditions: Hearing Loss

Summary: spatial hearing capacities of soldiers with acoustic trauma are evaluated in ent consultations with routine tests (i.e. tonal audiometry, voice audiometry). while the results conclude that soldiers with acoustic trauma have sufficient abilities to carry out professional missions, soldiers report recurring complaints of sound localization (spatial hearing), i.e. difficulties in identifying the position of sound sources in their environment. however, there is currently no objective test to identify and objectify these complaints of spatial hearing. the investigators have developed a new approach (sphere) based on virtual reality and 3d motion tracking, allowing us to evaluate and record the spatial hearing performance of subject with hearing deficit. this system allowed us to highlight localization deficits in three-dimensional space. this project explores and quantifies the spatial hearing impairments of soldiers with acoustic trauma. the quantification of the spatial hearing capacities will allow to define a specific rehabilitation strategy of spatial hearing deficits.


Eligibility criteria:
inclusion criteria: acoustic traumatized military group : * age between 18 and 65 inclusive * active or reserve military personnel * diagnosis of noise trauma for at least one month * regularly followed up in the ent department of the desgenettes army training hospital in lyon or in the medical offices of the army medical centers. * able to understand the experimental instructions * affiliated to a social security scheme * having been informed of the study and having given their agreement to participate normal hearing group : * age between 18 and 65 years inclusive * able to understand the experimental instructions * affiliated to a social security scheme * having been informed of the study and given their agreement to participate exclusion criteria: * known current or past neurological or psychiatric disorder * oculomotor/visual disorder * bilateral vestibular areflexia * person under court protection, guardianship or curatorship * pregnant or breastfeeding woman * known hearing loss for normal hearing group

Keywords: spatial hearing virtual reality acoustic trauma hearing loss