Kornimate/medical-research-clean huggingface dataset:
study to evaluate dupilumab monotherapy in pediatric patients with peanut allergy

Conditions: Peanut Allergy

Summary: the primary objective of the study is to assess the tolerability of peanut protein in pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability is defined as the proportion of patients who safely pass a double-blind placebo-controlled food challenge (dbpcfc) at week 24. the secondary objectives are: * to determine whether dupilumab treatment improves peanut tolerability, defined as a change in the cumulative tolerated dose (log transformed) of peanut protein during a dbpcfc * to evaluate the safety and tolerability of dupilumab treatment in peanut allergic patients * to evaluate the effects of dupilumab treatment on the levels of peanut-specific immunoglobulin e (ige) * to evaluate the treatment effect of dupilumab on the average wheal size after a titrated skin prick test (spt), as measured by area under curve (auc) of the average wheal size induced by peanut extract at different concentrations * to assess the incidence of treatment-emergent anti-drug antibodies (ada) to dupilumab in patients over time


Eligibility criteria:
key inclusion criteria: * patient has a clinical history of allergy to peanuts or peanut-containing foods (symptom\[s\] of reaction due to exposure). * experience dose-limiting symptoms at or before the challenge dose of peanut protein on screening dbpcfc conducted in accordance with practical issues in allergology, joint united states/european union initiative (practall) guidelines. and not experiencing dose limiting symptoms to placebo * serum ige to peanut of ≥10 kilo units (kua)/l and/or a spt to peanut ≥8 mm compared to a negative control * patients/legal guardians must be trained on the proper use of the epinephrine autoinjector device to be allowed to enroll in the study * patients with other known food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study key exclusion criteria: * any previous exposure to marketed dupilumab or dupilumab in a clinical trial * member of the clinical site study team or his/her immediate family * history of other chronic disease (other than asthma, ad, or allergic rhinitis) requiring therapy * history of frequent or recent severe, life-threatening episode of anaphylaxis or anaphylactic shock as defined by more than 3 episodes of anaphylaxis within the past year and/or an episode of anaphylaxis within 60 days of screening dbpcfc * history of eosinophilic gastrointestinal disease * history of eosinophilic granulomatosis with polyangiitis * severe, unstable asthma at time of enrollment or any patient with forced expiratory volume in 1 second (fev1) \ 1.5 * use of systemic corticosteroids within 2 months prior to screening note: other protocol inclusion/exclusion criteria apply
whole body magnetic resonance angiography in ischemic patients

Conditions: Atherosclerosis; Intermittent Claudication

Summary: to investigate the diagnostic performance of whole body magnetic resonance angiography (wb-mra) using two different magnetic resonance contrast agents.

atherosclerosis of the lower leg arteries is a common disease. patients with this condition has symptoms of ischemia, for instance intermittent claudication (pain during exercise). diagnosis of atherosclerosis in the legs is normally done with an interventional x-ray-based angiography (dsa- digital subtraction angiography). this is uncomfortable for the patient, and associated with risks of complications (bleeding, vascular damage, embolism).a novel approach to diagnosing atherosclerosis is the use of magnetic resonance angiography. a variant of this is the whole body magnetic resonance angiography(wb-mra), that produce a picture of the arteries in almost the whole body (excluding the coronary arteries). wb-mra has a number of advantages compared to dsa. it does not use ionizing radiation, is not invasive, uses a contrast medium with fewer side affects and finally gives a covers a great deal of the arteries in the body. this study will compare wb-mra with dsa in patients with symptoms of peripheral atherosclerosis in the lower legs. we will investigate 2 different contrast agents used for wb-mra. the patients will be randomized to receive either the contrast medium dotarem or the contrast medium vasovist. in both groups we will compare the results of wb-mra with dsa.

Eligibility criteria:
inclusion criteria: * symptomatic lower extremity ischemia (claudication, ischemic wounds) * referred to digital subtraction angiography (dsa) exclusion criteria: * renal insufficiency (gfr \< 30 ml/min) * contra-indications for mri-examination (claustrophobia, metal-implants, pacemaker) * dementia * pregnancy/lactation * allergy to gadolinium based mri contrast agents * acute disease

Keywords: magnetic resonance whole body angiography vasovist gadofosveset dotarem blood pool agent
piezoelectric vibrations and tissue, cellular and molecular mechanisms of oral wound healing after third molar surgery

Conditions: Tooth, Impacted

Summary: the aim of this clinical trial is to investigate and compare the effect of piezoelectric surgery on tissue, cellular and molecular level of oral surgical wound healing and postoperative outcomes (pain, swelling, trismus) after lower third molar surgery in healthy patients


Eligibility criteria:
inclusion criteria: * bilaterally symmetrically impacted lower third molars exclusion criteria: * presence of intraoral infection * chronic orofacial pain * pregnancy/ lactation * heavy tobacco smokers * alcohol/ drug abuse * allergic reaction to medicaments used

Keywords: piezolectric surgery conventional surgery lower third molars
effect of folate acid on offspring obesity

Conditions: Pediatric Obesity

Summary: the purpose of this study is to observe the effect of lack or excess of folic acid in first, second and third trimester on child birth weight, fat content and the secretion of metabolism related hormone, and clinical follow-up their offspring obesity.


Eligibility criteria:
inclusion criteria: * pregnancy women * children * chinese exclusion criteria: -
evaluation of using dienogest and n-acetyl cysteine on the volume of uterine leiomyoma

Conditions: Uterine Leiomyoma

Summary: this 2 arm randomized clinical trial will assess the impact of dienogest and n-acetyl cysteine on volume reduction of uterine leiomyoma

group a women will receive dienogest orally 2mg pills daily for 3 months .20 cases group b women will receive nac orally at a dose of 600 mg/day for 3 months ,20 cases

Eligibility criteria:
inclusion criteria: 1. age: 20-45 years. 2. women with uterine leiomyoma (sub-mucous, sub-serous or intramural) based on transvaginal sonography criteria. uterine fibroids most often appear as concentric, solid, hypoechoic masses. this appearance results from the prevailing muscle, which is observed at histologic examination. these solid masses absorb sound waves and therefore cause a variable amount of acoustic shadowing. 3. regular menstruation: regular period interval from 21 to 35 days. exclusion criteria: 1. pregnant or menopausal women. 2. history of malignancies, metabolic, hematologic, cardiac, thromboembolism, diabetes, renal or hepatic diseases. 3. history of hormonal drug use or treatment for leiomyoma in the past 3 months.

Keywords: fibroids dienogest nac
short term outcomes of acute cholecystitis managed at a university hospital

Conditions: Acute Cholecystitis

Summary: the aim of this retrospective study was to assess the different outcomes of early (performed on the patient's first admission for acute cholecystitis) and delayed cholecystectomy (done on a second admission) at king abdulaziz university hospital in jeddah, saudi arabia.

this study was conducted retrospectively through reviewing patients medical records

Eligibility criteria:
inclusion criteria: male and female patients who presented to the emergency department of kauh with an acute cholecystitis exclusion criteria: * patients with no acute cholecystitis

Keywords: acute cholecystitis cholecystectomy overweight bmi early delayed
effect of intraoperative taping on the control of edema resulting from stripping

Conditions: Edema; Varices; Cord

Summary: the aim of the study is to evaluate the effects of the contensive taping technique on the control of edema of patients submitted to phleboextraction surgery including saphenectomy.

edema is a common complication after stripping surgery, so measures that can help the resolution of the condition are important for the recovery in the post operative. the aim of the study is to evaluate the effects of the contensive taping technique on the control of edema of patients submitted to phleboextraction surgery including saphenectomy. therefore, 60 patients of both sexes will be invited to participate in the study, undergoing saphenectomy surgery, divided into two homogeneous groups, determined by the sample calculation. the intervention group (ig) will be composed of patients undergoing phleboextraction with saphenectomy and intervention with contensive taping, in intraoperative period associated with compression with elastic stockings. the control group (cg) will be composed of patients undergoing the same surgical procedure, and standard treatment consisting only of compression by elastic stockings. the procedures for evaluation will be applied before and after seven days of therapeutic intervention. for data analysis, the normality test will be performed and distribution, in addition to a suitable statistical test for the appropriate intra and intergroups, with a significance level of 5%.

Eligibility criteria:
inclusion criteria: * young adults, aged from 25 to 59 years old, submitted to stripping and saphenectomy. exclusion criteria: * allergies * skin lesions * ulcers.

Keywords: functional bandages edema ultrasound varices
prospective registery of smell/taste clinic ear/nose/throat

Conditions: Olfactory Disorder; Taste Disorders; Smell Dysfunction; Smell Disorder

Summary: smell/taste disorders are common conditions with a significant impact on quality of life. in september 2021, a specific consultation for patients with smell and taste disorders was initiated at the ent-hns (ear, nose, and throat, head and neck surgery) department of uz leuven, partly in light of post-covid-19 related smell disorders. with this observational ambidirectional study, we aim to better map smell/taste disorders in the belgian/flemish population. using standard-of-care diagnostic tests and structured questionnaires, we strive to gain more insight into the severity, impact, and progression/prognosis of smell/taste disorders.


Eligibility criteria:
the psychophysical testing as well as the questionnaires require a cooperative participant who can understand and follow instructions and communicate their choices. informed consent is necessary upon participation for prospective registry. there are no exclusion criteria related to sex, gender, or ethnicity. there are no exclusion criteria related to medical history or prior treatments. this study conveys no additional risks for care groups such as pregnant women, or elderly
efficacy/safety study of brisdelle™ (formerly known as mesafem) in the treatment of vasomotor symptoms (vms)

Conditions: Postmenopausal Symptoms

Summary: the purpose of this study is to assess the safety \& efficacy of brisdelle (paroxetine mesylate) capsules 7.5 mg for treatment of vasomotor symptoms (vms) associated with menopause.

this is 12-week, multicenter, double-blind, randomized, placebo-controlled study of brisdelle (paroxetine mesylate) capsules 7.5 mg and placebo capsules in subjects with moderate to severe postmenopausal vms, defined as follows: * moderate vms: sensation of heat with sweating, able to continue activity * severe vms: sensation of heat with sweating, causing cessation of activity the study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.

Eligibility criteria:
inclusion criteria: 1. female, ≥ 40 years of age at screening (inclusive) 2. reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior to the screening visit 3. spontaneous amenorrhea for at least 12 consecutive months or 4. amenorrhea for at least 6 months and meet the biochemical criteria for menopause or 5. bilateral salpingo-oophorectomy ≥ 6 weeks with or without hysterectomy exclusion criteria: 1. known non-responder to previous selective serotonin reuptake inhibitor (ssri) or serotonin norepinephrine reuptake inhibitor (snri) treatment for vms 2. history of self injurious behavior 3. history of clinical diagnosis of depression or treatment for depression 4. history of clinical diagnosis of borderline personality disorder 5. use of an investigational study medication within 30 days prior to screening or during the study 6. concurrent participation in another clinical trial or previous participation in this trial 7. family of investigational-site staff

Keywords: menopause vasomotor symptoms hot flashes perimenopause climacteric symptoms mesafem low-dose mesylate salt of paroxetine (ldmp)
fibrinogen to albumin ratio (far) as a predictive biomarker for lupus nephritis (ln)

Conditions: Lupus Nephritis

Summary: fibrinogen to albumin ratio as a predictive biomarker for lupus nephritis (ln)

systemic lupus erythematosus is a chronic autoimmune disease often coexists with other diseases and damages multiple organs such as kidney liver nervous system and so on. lupus nephritis is clinically evident in 50-60% of patients with systemic lupus erythematosus and it is histologically evident in most sle patients even those without clinical manifestations of kidney disease . the current standardized classification system for lupus nephritis is derived from the world health organization and the international society of nephrology/renal pathology society's recommendations. the classification system is based on glomerular morphologic changes seen on microscopy immune deposits seen on immunofluorescence and also electronic microscopy. class 1 - minimal mesangial lupus nephritis. class 2 - mesangial proliferative lupus nephritis. class 3 - focal lupus nephritis. class 4 - diffuse lupus nephritis. class 5 - membranous lupus nephritis. class 6 - advanced sclerosis lupus nephritis. fibrinogen (fib) is an acute time response protein rises rapidly in inflammation infection myocardial infarction and tumor. the formation and deposition of immune complexes are important mechanism of lupus nephritis the infiltrate of inflammatory cells and the release of inflammatory factors cause renal injury resulting in the decreasing concentration of albumin. the fibrinogen-to-albumin ratio as a new inflammatory marker has been proved to have good predictive value in the diagnosis and prognosis of diabetic nephropathy acute renal injury sle disease and so on.

Eligibility criteria:
inclusion criteria: 1. 90 pts with sle that have ln in different classes. 2. age between 18-60 yrs. exclusion criteria: 1. pts with esrd, manifested cardiac valvular disease, acute infection, history of hepatitis, pts with dm and cancer. 2. age below 18 yrs\& above 60 yrs 3. pt who refused to contribute in this study
a phase i, single dose study of pf-04360365 in japanese patients with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to examine the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of pf-04360365 in japanese subjects with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * japanese male or females of non-childbearing potential, ages 50-85 * diagnosis of probable alzheimer's disease, consistent with criteria from both: (1) national institute of neurological and communicable disease and stroke and alzheimer's disease and related disorders association (nincds-adrda) 2) text revision of the diagnostic and statistical manual of mental disorders (dsm-iv-tr) * mini-mental status exam score of 16-26 inclusive * rosen-modified hachinski ischemia score \< or = 4 exclusion criteria: * diagnosis or history of other dementia or neurodegenerative disorders * diagnosis or history of clinically significant cerebrovascular disease * specific findings on magnetic resonance imaging (mri): cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities * history of autoimmune disorders * history of allergic or anaphylactic reactions
simple simulation based breast cancer awareness training

Conditions: Breast Cancer Awareness Training

Summary: it was planned to determine the effect of simple simulation-based breast cancer awareness training on women's breast cancer knowledge and fear levels. the research population will consist of female service personnel working in institutions within the university of health sciences (sbü) (n: 670). in order to determine the sample size in this research, which was planned as a quasi-experimental with a pre- and post-test design and a control group; the data showed a normal distribution, the standard deviation of the population was estimated to be 1, and the effect size (difference) was estimated to be 0.8. it was calculated that if two independent n₁=40, n₂=40 samples were taken for the analysis to be carried out, at a 5% significance level, the maximum power value of the research would be 0.942182. both groups will be given theoretical training about breast cancer awareness, and women in the intervention group will practice breast cancer awareness with a simple valid simulator. all groups will be informed before the applications. the training content will be supported by distributing a 5-page training booklet created from breast health and cancer awareness content to the participants. "comprehensive breast cancer knowledge test", "breast cancer fear scale" and "breast cancer awareness scale" will be applied as a pre-test after the information.


Eligibility criteria:
inclusion criteria: * volunteering to participate in the research. * to work as female service personnel in institutions within the university of health sciences. exclusion criteria: - not participating in all applications of simulation teaching.

Keywords: simulation based breast cancer awareness
a single intra-articular injection of amat vs prp in patients with oa of the knee

Conditions: Osteoarthritis, Knee

Summary: the study proposes to compare performances and safety of intra-articular injections of amat with those of a control group (prp injections) for the treatment of symptomatic oa of the knee. the end-points will be determined evaluating the performances of the treatment group in terms of improvement of the symptomatology, functional recovery and radiological appearance.

the clinical trial is a prospective, randomized, controlled, two-arm, single-blind study, involving 118 patients affected by symptomatic oa of the knee joint. eligible subjects will be randomly allocated to one of the two treatment groups, with a 1:1 randomization ratio. respectively, 59 patients treated with a single intra-articular injection of amat, and 59 patients treated with a single intra-articular injection of prp. the patients enrolled in the study will be treated according to the study protocol and followed after treatment with periodic visits and diagnostic imaging examinations, as magnetic resonance imaging at twelve and twenty-four months follow-up and x-ray, at three, six, twelve, and twenty-four months of follow-up.

Eligibility criteria:
inclusion criteria 1. patients provided written informed consent; 2. patients aged between 18 and 75 years; 3. knee symptomatic oa (kellgren-lawrence grade 1-4) 4. failure of conservative treatment for at least 3 months; 5. patients agreed to actively participate in the rehabilitation protocol and follow-up program; 6. male or female patients; 7. women of childbearing age had to use a proven method to prevent pregnancy, before the surgical treatment. exclusion criteria 1. patients incapable to understanding and will; 2. patients participating in previous, concurrent or not, trials (ongoing or completed within three months); 3. patients surgically treated for the same defect within one year; 4. patients affected by malignancy; 5. patients affected by metabolic or thyroid disorders; 6. patients used to alcohol or drug (medication) abuse; 7. patients affected by synovitis; 8. varus or valgus misalignment exceeding 15°; 9. body mass index \> 40; 10. patients with trauma within 6 months pre-operative.

Keywords: oa amat prp
effect of physical activity through interactive video games in overweight children

Conditions: Obesity; Overweight

Summary: the purpose of this study is to determine the effect of interactive video game in management of overweight in children. the investigators will evaluate the effect of product versus standard physical activity.

background. child overweight and obesity are a world public health problem, in low income countries is more. one difficulty in the management is the poor adherence to physical activity, some studies show that active video games could improve this. objective: establish the effect of the introduction of active video game (nintendo wii) on fitness, anthropometry and adherence to treatment, as part of an intervention program for the management of childhood obesity in children over 5 years of age with obesity methodology: a clinical trial, randomized and controlled. children between 5-10 years with a diagnosis of overweight or obese, were divided into two groups. (wii group), received 3 weekly sessions of one hour of physical activity by an active video game, the other group (control group) received 3 weekly sessions of one hour of physical activity by static exercises.

Eligibility criteria:
inclusion criteria: * children aged 5-10 years with a diagnosis of overweight or obese (according to who criteria) exclusion criteria: * overweight or obese due other disease.

Keywords: bmi obesity overweight child physical activity