Kornimate/medical-research-clean huggingface dataset:
ige-mediated allergies among type 1 diabetes mellitus children, single centre observational study

Conditions: Diabetic Children

Summary: an interviewer-administrated questionnaire was designed to take history of allergy in diabetic child come to outpatient clinic fulfilling inclusion criteria and used to collect data. skin prick testing was performed to all diabetic children with history of allergy. laboratory assessment of serum total ige, il5 and eosinophils%.


Eligibility criteria:
inclusion criteria: * children with at least 2 years duration of diabetes diagnosed by criteria for the diagnosis of diabetes mellitus (ispad 2018) that include: * classic symptoms of diabetes or hyperglycemic crisis, with plasma glucose concentration ≥11.1 mmol/l (200 mg/dl). * fasting plasma glucose ≥7.0 mmol/l (≥126 mg/dl). fasting is defined as no caloric intake for at least 8 hours. * two-hour post load glucose ≥11.1 mmol/l (≥200 mg/dl) during an oral glucose tolerance test (ogtt). * hba1c ≥6.5%. exclusion criteria: * presence of other chronic disease associated with dm.
effect of dihydrocapsiate on energy expenditure in women

Conditions: Obesity

Summary: the objective of this study is to test the effect of dihydrocapsiate on energy expenditure in women.

capsaicin, a substance found in chili pepper, is known to stimulate thermogenesis. dihydrocapsiate, a capsinoid, found in the non-pungent ch-19 sweet pepper has similar thermogenic effects without the gastrointestinal side effects. the objective of this project is to test the effect of 12 weeks of daily consumption of 9 mg dihydrocapsiate on resting energy expenditure relative to baseline when compared to a control group consuming products without dct.

Eligibility criteria:
inclusion criteria: * bmi: 18.5-34.5 kg/m2 * good general health * low to mild physical activity * willing to maintain habitual diet and physical activity patterns throughout the study period * premenopausal and cycling regularly or using oral contraceptives * willing to attend study visits only during the follicular phase or bleed phase of their menstrual cycle * understands study procedures and signs forms providing informed consent to participate in the study * have spoken and written english literacy exclusion criteria: * diabetes mellitus or any conditions that might affect energy metabolism * weight change ±2 kg over previous three months * known sensitivity or allergy to ingredients of the study products * non-breakfast eater * recent use of antibiotics * history of smoking during the six months prior to study * recent signs or symptoms of infection, including cold or flu-like symptoms * concurrent or recent intervention study participation * instability in breathing patterns or energy expenditure measures * history of drug or alcohol abuse * lipid-lowering, anti-hypertensive or anti-inflammatory steroid medication use * weight loss medication * pregnant or lactating * unwilling to be randomized to any experimental group and unable to meet all requirements of the study

Keywords: obesity body weight body composition metabolism resting energy expenditure
pretreatment staging of high-risk prostate cancer with 18f-fluciclovine pet/mri

Conditions: Prostate Cancer

Summary: there is great need for improved preoperative imaging in men with high-risk prostate cancer. investigators propose to develop and validate an optimized simultaneous pet/mri protocol for local, regional and whole body preoperative staging in a single imaging session using the amino acid pet tracer, f-18 fluciclovine. despite advances in the diagnosis and treatment of prostate cancer, the preoperative staging of men with prostate carcinoma (pca) is currently problematic. conventional imaging is falsely negative for regional lymph node metastases in a substantial fraction of men. in particular, approximately 35% of men with high-risk prostate cancer will have biochemical recurrence even after optimal surgical resection. a major benefit of simultaneous acquisition of a multiparametric prostate mri (mpmri) and f-18 fluciclovine pet includes having the patient undergo a single imaging study which provides both anatomic and molecular characterization of the tumor, including metastases which would potentially be missed by conventional anatomic imaging and size criteria. additionally, simultaneous acquisition will improve co-registration of the pet and mr data which is valuable for small lesions and in anatomically complex regions. although the use of fluciclovine in the characterization of the primary pca remains to be established, the anatomic detail provided by conventional mpmri will complement the detection of small volume metastatic disease by fluciclovine pet. additionally, the use of hybrid pet/mri technology allows for the assessment of dynamic tracer uptake and washout during the whole body and regional pet/mri scan, which may demonstrate the ability to increase detection of the primary pca on fluciclovine pet. if f-18 fluciclovine pet/mri can reliably and accurately detect nodal metastases in high-risk prostate cancer patients, surgeons may use this new technology to develop new treatment algorithms for the optimal management of these patients.


Eligibility criteria:
inclusion criteria: - high-risk biopsy-proven treatment-naïve prostate adenocarcinoma (gleason score ≥ 8 and/or serum psa \> 20) exclusion criteria: * inability to tolerate or undergo pet/mri * previous or current hematologic or lymphatic disorder (including leukemia, lymphoma, castleman's disease, etc.) * recurrent prostate adenocarcinoma * known visceral, osseous, or extrapelvic metastases prior to fluciclovine-pet/mri * known allergy to glucagon or gadolinium-based contrast
long-term effects of non-invasive ventilation in hypercapnic chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: in this multicenter study the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for ventilation/ perfusion (v/q) matching) with functional respiratory imaging (fri) and arterial blood gas (abg) values will be evaluated in hypercapnic chronic obstructive pulmonary disease (copd) patients. therefore a low dose computed tomography (ct) scan will be taken in a population of 30 patients with non-invasive ventilation (niv) and in a control group of 10 patients without niv. the ct-scan will be used for fri.


Eligibility criteria:
inclusion criteria: * age: ≥ 40 years old * men and women * written informed consent obtained * copd patients gold ii, iii and iv * persisting hypercapnia (pco2 \> 45 mmhg ) notwithstanding adequate treatment modalities (including oxygen) as proposed by the gold guidelines * stopped smoking * total lung capacity (tlc) \> 85% exclusion criteria: * treatment with home niv or continuous positive airway pressure (cpap) * asthma * restrictive lung disease * symptomatic or uncontrolled heart failure * current malignancy * suspected bad compliance for niv treatment * pregnant women * not be able to speak the language of the participating center * received an investigational product within 4 weeks prior to inclusion in the study

Keywords: chronic obstructive pulmonary disease gold stages ii, iii and iv computed tomography scan functional respiratory imaging non-invasive ventilation arterial blood gas hypercapnic health related quality of life lung compliance
neurologic and immunologic characteristics of ctla-4 and lrba hereditary deficiency

Conditions: CTLA4 Haploinsufficiency

Summary: ctla4 and lrba deficiencies are rare genetic disorders, recently described, and associated with multiple clinical features. it ranges from recurrent infections, auto-immunity, and organ infiltration with lymphocytes. neurologic syndroms are described in up to 30% of patients, yet they are poorly defined to date. early recognition of a specific pattern can be important, given that there is a targeted therapy in this situation.


Eligibility criteria:
inclusion criteria: - patients diagnosed with ctla4 or lrba mutation exclusion criteria: - age \< 12 years

Keywords: lrba deficiency primary immunodeficiency neuroinflammation genetic diseases autoimmune diseases
montelukast post-marketing comparative study with ketotifen (0476-379)

Conditions: Asthma

Summary: the clinical study evaluates the safety of montelukast and compares montelukast to ketotifen, used as a control drug, in terms of improvement in morning peak expiratory flow (am pef) over first 2 weeks in patients with pediatric bronchial asthma aged 6 to \< 15. the effect of body weight on the efficacy and safety of montelukast will also be evaluated in this study.


Eligibility criteria:
inclusion criteria: * intermittent asthma, mild persistent asthma, moderate persistent asthma, or severe persistent asthma patients with 2 or more mild or moderate attacks at baseline exclusion criteria: * patient using anti-asthma treatment or therapy including corticosteroids or oral anti-allergic drugs * patient with complications that will impair the judgment of efficacy of this drug * patient with convulsive disorders such as epilepsy or such a history * patient with liver disease, renal impairment, heart disease or such other complication
comparative study of learning curve for first trimester fetal anomaly scan

Conditions: First Trimester Pregnancy

Summary: ultrasound scans during first trimester are more difficult than routine mid-trimester ultrasound scans. practice guidelines for first trimester fetal ultrasound scans have been provided by the international society of ultrasound in obstetrics and gynecology (isuog) since 2013. using this guidelines, different levels of proficiency operators might have equal ability to complete first trimester ultrasound scans.

nowadays, high-resolution transabdominal ultrasounds are widely used, and ultrasound scans for fetal structural abnormalities at the first trimester are indeed possible. first trimester ultrasound scans are important and essential for detecting fetal structural anomalies, and they help provide optimized early antenatal management. however, ultrasound scans, during this period, are more difficult than routine mid-trimester ultrasound scans, as fetal organs are small and experienced operators are needed to use the transducer to obtain informative pictures. practice guidelines for first trimester fetal ultrasound scans have been provided by the international society of ultrasound in obstetrics and gynecology (isuog) since 2013. since then, the percentage of complete scans and the high detection rate of fetal structural abnormalities during first trimester ultrasound scans have been reported. from our perspective, ultrasound operators who have different experiences in mid-trimester ultrasound scanning might have equal ability to complete first trimester ultrasound scans using the isuog guidelines. the objective of this study is to compare the rate of completed scans regarding fetal structures at the first trimester ultrasound scan between two different levels of proficiency operators.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * maternal age ≥ 18 years * gestational age between 11-13 + 6 weeks by last menstrual date or ultrasound report if uncertain date exclusion criteria: * multifetal gestation * miscarriage before first trimester ultrasound * loss to follow up at mid-trimester ultrasound scan * loss to follow up after birth

Keywords: first trimester ultrasound scan learning curve isuog practice guidelines
lv diastolic function vs ivc diameter variation as predictor of fluid responsiveness in shock

Conditions: Shock; Septic Shock

Summary: fluid responsive is defined as increasing in cardiac output or stroke volume by 10-15% after fluid challenge. left ventricular diastolic dysfunction is associated with lower left ventricular end-diastolic volume (lvedv) resulting in a less cardiac output increment after fluid challenge. however, left ventricular diastolic function indicated by the mitral e/e' ratio from transthoracic echocardiography, was rarely studied for fluid responsiveness evaluation.

fluid therapy is one of the main treatments in patients with shock to increase oxygen delivery by increasing cardiac output or stroke volume. however excess fluid intake may cause fluid overload, resulting in tissue edema, lung edema and organ dysfunction, which can lead to patient deterioration. fluid responsiveness, defined as increasing in cardiac output or stroke volume by 10-15% after fluid challenge, is being recommended to evaluate in-patients with shock, according to european society of intensive care medicine (esicm). cardiac output measurement is often invasive or requires an expensive device, therefore, tests for predicting fluid responsiveness have been used to substitute direct cardiac output measurement. left ventricular diastolic dysfunction is associated with a decreasing left ventricular end-diastolic volume, resulting in a less cardiac output increment after fluid challenge and can be measured by using mitral e/e' ratio via transthoracic echocardiography. despite being a non-invasive test, the mitral e/e' ratio obtained from echocardiography was rarely studied for the prediction of fluid responsiveness.

Eligibility criteria:
inclusion criteria: * age more than 18 years * diagnosis of shock defined by systolic blood pressure \< 90 mmhg or mean arterial blood pressure \< 65 mmhg and/or clinical hypoperfusion * mechanically ventilated without ventilator dyssynchrony and no ventilator triggering * present of central venous cather or arterial catheter exclusion criteria: * age \< 18 years * frankly hypovolemic shock or hemorrhagic shock * suspicious of cardiogenic shock * suspicious of acute decompensated heart failure * suspicious of acute coronary syndrome * denied participation or denied inform consent

Keywords: shock fluid responsiveness left ventricular diastolic dysfunction mitral e/e'
safety study of roflumilast cream 0.05% in infants aged 3 months to less than 2 years with atopic dermatitis

Conditions: Atopic Dermatitis (Eczema)

Summary: this study will assess the safety and tolerability of arq-151 cream 0.05% applied once a day for 4 weeks in infants with atopic dermatitis (eczema).

this study is an open label safety study in which arq-151 cream 0.05% is applied once a day for 4 weeks in infants with atopic dermatitis (eczema).

Eligibility criteria:
inclusion criteria: 1. informed consent of a parent(s) or legal guardian(s), as required by local laws. 2. males and females, ages 3 months to \<2 years old at day 1. 3. diagnosed with mild to moderate atopic dermatitis (ad) for at least 1 month duration prior to or at the screening visit. 4. has ad involvement of ≥3% bsa at day1. 5. in good health as judged by the investigator 6. subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the protocol and visit schedule, according to the judgment of the investigator. exclusion criteria: 1. subjects with any serious medical condition, clinically significant vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the investigator. 2. subjects who have unstable ad or any consistent requirement for high potency topical steroids to manage ad signs or symptoms. 3. subjects previously treated with arq-151 4. subjects currently undergoing allergy testing or food challenges, or plan to do so during the study. 5. parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language. subjects who display another condition, which in the investigator's opinion, makes them unsuitable for clinical study participation. 6. subjects who are family members of the clinical study staff or sponsor.

Keywords: atopic dermatitis eczema
evaluation of minimally invasive microdiscectomy versus conventional open microdiscectomy for lumbar herniated disc

Conditions: Lumbar Herniated Disc

Summary: overall objective: to evaluate pain and functional status of patients undergoing surgical correction for lumbar herniated disc, pre- and post-surgery, using subjective (vas, oswestry, psqi, patient expectation), as well as, objective measures of physical activity (triaxial accelerometry). design and methods: two groups of subjects will be examined; 1) patients diagnosed with lumbar herniated disc undergoing minimally invasive microdiscectomy (md), and 2) patients diagnosed with lumbar herniated disc undergoing open microlumbar discectomy (od). subjects who agree to participate, will be assessed (assessments listed below) after the diagnosis and prior to surgery. the subject will then be assessed postop and they will continue with follow-up after surgery with a visit at 3 weeks postop. both methods of discectomy will be discussed with the subject. once the subject has consented to participate (and prior to surgery), subjects will be randomized with a 50/50 chance of being placed in the md or od groups. subjects will be distributed into the md group and the od group using a block randomization method. the study will be single blinded. a longitudinal, within group, comparison will be made to assess the change in the measured parameters. data involving the md and od groups will be accumulated in a cross-sectional fashion. subjects will be recruited from the referrals to the practices of the orthopedic and neurosurgeon spine surgeons at the health sciences centre. this encompasses the majority of new and currently managed cases in the manitoba and northwestern ontario. subjects will be between the ages of 18 and 90. male and female subjects will be recruited into the study. all patients will clinically demonstrate unilateral lower extremity pain in greater proportion to low back pain symptoms if present. imaging (ct) will document single level lumbar herniated nucleus pulposis. exclusion criteria will be cauda equina syndrome, progressive neurologic deficit, bilateral lower extremity symptoms, low back pain more than leg pain, the existence of significant co-morbidity (e.g. cardiac condition, disease, etc.) of any form, and any other physical limitations (musculoskeletal injury). subjects participating will be required to speak and read english.


Eligibility criteria:
inclusion criteria: * subjects will be between the ages of 18 and 90. * male and female subjects will be recruited into the study. * all patients will clinically demonstrate unilateral lower extremity pain in greater proportion to low back pain symptoms if present. imaging (ct) will document single level lumbar herniated nucleus pulposis. * subjects participating will be required to speak and read english. exclusion criteria: * cauda equina syndrome, progressive neurologic deficit, bilateral lower extremity symptoms, low back pain more than leg pain, the existence of significant co-morbidity (e.g. cardiac condition, disease, etc.) of any form, and any other physical limitations (musculoskeletal injury).
repair by rehabilitation of pelvic floor lesions after vaginal delivery identified by transperineal ultrasound 3/4 d

Conditions: Pelvic Floor Disorders; Obstetric Trauma; Physical Disorder; Physical Activity

Summary: summary: (objective, design, scope of the study, subjects of study, instrumentation, results, conclusions) objectives: to evaluate if the physiotherapy treatment in pelvic floor dysfunctions, identified by transperineal ultrasound 3 / 4d, in postpartum improve the tone and functionality of pelvic floor. design: post-authorization, prospective, longitudinal randomized intervention study scope: full-term deliveries at the university hospital. subjects of study: full-term primiparous and full-term pregnancies with pelvic floor lesion, identified by transperineal ultrasound 3 / 4d, which are randomized between the physiotherapy treatment of pelvic floor and the non-work. variables: primary variable: assess the improvement in contractility / tone, evaluation by manometry and assess the anatomical improvement of the area of ?? the genital hiatus, stay by transperineal ultrasound 3 / 4d. secondary variables: identify the levator ani muscle injury rate, estimate the sonographic changes in the levator ani muscle through rehabilitation. analyze the improvement of the symptoms associated with the public organic prolapse and evaluate the improvement of the quality of life. data analysis: to detect a difference of 10% in the reduction of the size of the index between the study groups (not intervened / intervened) after 6 months of intervention, standard deviation 10%, error-alpha 5%, error- beta 10% (p90%) we need 23 women in each group. assuming a loss of 10% in the follow-up, the final size would be 52 women, 26 per group.


Eligibility criteria:
inclusion criteria: * vaginal delivery * cephalic presentation * primiparity * at term gestation (37-42 weeks) * no prior pelvic floor corrective surgery * written informed consent exclusion criteria: * pregnancies with severe maternal or fetal pathology
evaluate safety and efficacy of abt-335 in combination with simvastatin in subjects with multiple abnormal lipid levels in the blood

Conditions: Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia

Summary: the purpose of this study is to compare the safety and efficacy of fenofibric acid (abt-335) + simvastatin combination therapy with abt-335 and simvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.


Eligibility criteria:
inclusion criteria: * subjects with mixed dyslipidemia * subjects agree to utilize adequate birth control methods and to adhere to the american heart association (aha) diet. exclusion criteria: * subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial. * patients who are taking certain medications or unstable dose of specific medications. * women who are pregnant or plan on becoming pregnant, or women who are lactating.

Keywords: dyslipidemia coronary heart disease mixed dyslipidemia
influence of gum disease treatment on long-term dental implant success

Conditions: Periodontitis

Summary: the aim of this study is to evaluate the influence of periodontal care response on long term dental implant success. investigator's hypothesis is that patients who do not well respond to periodontal care have more chance to develop peri-implant complications at long-term. the second purpose of this study is to evaluate the influence of other local, systemic, behavioral, and implant's related risk factors


Eligibility criteria:
inclusion criteria: patient attending supporting periodontal therapy with at least one implant placed for more than 3 years * patient with more than 12 teeth at baseline * patient with demographic, periodontal, implant data recording * patient aged \>30 years at baseline exclusion criteria: * patient needed antibiotic prophylaxis * uncontrolled diabetes * systemic inflammatory or autoimmune diseases