Kornimate/medical-research-clean huggingface dataset:
circadian misalignment and insulin sensitivity

Conditions: Diabetes Mellitus, Type 2; Insulin Resistance

Summary: this study will evaluate the effect of circadian misalignment on insulin sensitivity in healthy lean subjects in a randomized cross-over design. subjects will be admitted to the research facility for two study periods of 3 and 3.5 days. in one of the study periods, the behavioral cycle will be shifted by 12 hours. insulin sensitivity will be measured with a hyperinsulinemic euglycemic clamp.

recent evidence shows that misalignment of the circadian rhythm (e.g. by rotating shift work) impairs glucose metabolism markedly, possibly by decreasing insulin sensitivity in peripheral tissues and liver. nowadays our society is indispensably connected to a lifestyle that allows wakefulness at every time of the 24 hours cycle. social jetlag is a phenomenon that affects a large part of the general population, thus circadian misalignment extends far beyond those who are on a shift work schedule. therefore, decreased insulin sensitivity in individuals affected by circadian misalignment may help to explain the increased prevalence of t2dm in night shift workers that has been found in epidemiological studies. the study is an interventional randomized crossover trial in which each subject serves as it owns control. for the study, the investigators ask the subjects to participate in two study periods, one of 3 days length (control condition) and the other of 3.5 days length (misalignment condition). during the 3.5 day misalignment condition, subjects will shift their day-night rhythm by 12 hours, which will lead to maximal circadian misalignment. insulin sensitivity will be measured by a hyperinsulinemic euglycemic clamp. secondary parameters will include ex-vivo skeletal muscle mitochondrial function and whole-body energy metabolism.

Eligibility criteria:
inclusion criteria: * caucasian * healthy (as determined by dependent physician based on medical questionnaire) * male * age: 18-35 years * normal bmi (18-25 kg/m2) * regular sleeping time (normally 7 - 9h daily) * habitual bedtime at 11 pm ± 2 hours exclusion criteria: * extreme early bird or extreme night person * heavily varying sleep-wake rhythm * shiftwork during last 3 months * travel across \>1 time zone in the last 3 months * engagement in exercise \> 3 hours total per week * using \> 400mg caffeine daily * smoking * unstable body weight (weight gain or loss \> 3kg in the last 3 months) * significant food allergies/intolerance (seriously hampering study meals) * participation in another biomedical study within 1 month before the first study visit * claustrophobia * medication use hampering the study (as determined by responsible physician) * recent blood donation. * any contra-indication to the telemetric pill: * any acute condition, exacerbation of chronic condition, or medical history that would in the investigator's opinion interfere with the study

Keywords: circadian rhythm circadian misalignment insulin sensitivity
pneumonia chart review cambodia

Conditions: Pneumonia

Summary: this study aims to answer the question of what is the burden of lower respiratory disease (pneumonia) among children ages 1 month to 5 years of age in rural cambodia. the primary objective will be to quantify the prevalence of severe pneumonia at chenla children's healthcare, a hospital in the rural town of kratie, cambodia. this will involve a chart review of the medical records available at chenla children's healthcare.


Eligibility criteria:
inclusion criteria: * children between the ages of 1 month and 5 years admitted to chenla children's healthcare with at least one admitting diagnosis being pneumonia or bronchiolitis will be included. exclusion criteria: * children who do not fall into the aforementioned age range and who do not have "pneumonia" or "bronchiolitis" as one of the admitted diagnoses.
correlation between balance and attention in children with attention deficit hyperactivity disorder

Conditions: Attention Deficit Disorder

Summary: objective: the purpose of the current study was to investigate balance in children with attention deficit hyperactivity disorder compared to normal subjects. furthermore, it studied the relationship between their balance and the total percentile scores of the adhd rating scale iv.

objective: the purpose of the current study was to investigate balance in children with attention deficit hyperactivity disorder contrasted to normal subjects. furthermore, it studied the relationship between their balance and the total percentile scores of adhd rating scale-iv. design: the study was a cross-sectional design. methods: sixty children were involved in this research from both sexes (42 boys and 18 girls) with age ranged from 60 to 84 months. they were subdivided into two groups based on the adhd rating scale-iv. the control group included 30 normally developed children from both sexes (20 boys and 10 girls) with a mean age of 67.53 ± 1.41 months, and the total percentile scores of adhd rating scale-iv ≤ 50. the study group comprised of 30 children from both sexes (22 boys and 8 girls) with attention deficit hyperactivity disorder (adhd) with a mean age of 68.60 ± 4.62 months. the total percentile scores of adhd rating scaleiv were ≥ 93. both groups were investigated for their balance by pediatric balance scale (pbs).

Eligibility criteria:
sixty children were involved in the present research from both sexes (42 boys and 18 girls) which were subdivided into two equal groups (control and study groups). they were recruited from different kindergartens at cairo, egypt, based on the following criteria: inclusive criteria: * age ranged from 60 to 84 months. * selected from both sex. * children in the study group with attention deficit hyperactivity disorder (adhd) based on the adhd rating scale-i with total percentile scores ≥ 93, children in control group normally developed with total percentile scores of adhd rating scale-iv ≤ 50. exclusive criteria: - no history of cerebral palsy, epilepsy or head trauma.
pelvic examination in pregnancy

Conditions: Early Pregnancy Bleeding; Abdominal Pain

Summary: this study is designed to determine whether the pelvic examination (including bimanual and speculum examination) is necessary in patients with first trimester vaginal bleeding/ lower abdominal pain when an intra-uterine pregnancy (iup) is seen on ultrasound. patients with the chief complaint of vaginal bleeding or lower abdominal pain less than 16 weeks and positive hcg will be considered for this non-inferiority-designed clinical trial. all patients who present to the bmc emergency department (ed) mon - fri from 8am to 11pm and have had serum or urine hcg testing and a formal ultrasound by a credentialed emergency physician or radiology technician as part of standard of care will be screened for further eligibility. those patients with intra-uterine pregnancies \< 16 weeks gestation seen on ultrasound and meet inclusion criteria will then be asked to provide informed consent to participate in the study. randomization will occur after consent has been obtained. half of the patients will be randomized to receive pelvic examinations and the other half will not. further care will be determined by the treating attending physician. the primary outcome will be a composite morbidity endpoint at 30 days, including return visits to the ed, emergency surgery, need for transfusion, infection, or other missed source of bleeding/ pain. secondary outcomes of interest include ed throughput time, and patient satisfaction.


Eligibility criteria:
inclusion criteria: 1. chief complaint of vaginal bleeding or lower abdominal pain 2. intra-uterine pregnancy seen on ultrasound 3. date \< 16 weeks by estimated lmp or ultrasound 4. age \>21 5. ability to provide written informed consent 6. english speaking exclusion criteria: 1. already enrolled in study 2. morbid obesity (bmi \> 40) 3. pelvic exam performed prior to ultrasound results 4. prisoner 5. follow up cannot be assured 6. admitted to hospital 7. large amount of vaginal bleeding (\>10 pads in 24 hours or equivalent) 8. unstable vital signs (sbp\ 110) 9. known cervical carcinoma in the past 1 year 10. clinical suspicion for alternative syndrome that requires pelvic exam (such as severe pain consistent with ovarian torsion) 11. report or suspicion of penetrating vaginal trauma 12. suspicion of active labor 13. reported sexual assault 14. current pregnancy by ivf 15. iud in place 16. suspicion of heterotopic pregnancy on ultrasound
study to evaluate efficacy and safety of nds-446 in men with lower urinary tract symptoms (luts)

Conditions: Lower Urinary Tract Symptoms

Summary: prospective, randomized, double-blind, placebo controlled clinical trial to study the efficacy and the safety of nds-446 (500 mg/cap) in men 45 years of age or older with moderate to severe lower urinary tract symptoms (luts)


Eligibility criteria:
inclusion criteria: 1. men ≥45 years of age. 2. luts, based on ipss total score ≥8 and \<25 3. peak urinary flow rate (qmax) ≥4 and ≤15 ml/sec at screening 4. post void residual (pvr) urine volume ≤ 200 ml at screening 5. psa level at screening \ 4ng/ml and \< 10 ng/ml are eligible only if prostate cancer has been ruled out 6. subjects who understand and speak english 7. able and willing to give informed consent and comply with all study protocol procedures (diaries and other study tools). exclusion criteria: 1. not suitable for medical intervention (e.g., requiring turp, etc.) 2. history of interstitial cystitis, bladder stones, urethral stricture, current prostatitis, acute urinary retention requiring catheterization in the last 3 months, or any other condition suspected to be the cause of luts other than bph 3. screening serum creatinine (cr) or liver function tests \[alt (sgpt), ast (sgot)\] \> 3 times the upper limit of normal (uln) confirmed on a second measurement. 4. cancer of the prostate or bladder by history or current diagnosis. 5. prostate nodule(s) on screening digital rectal exam (dre). 6. prior surgical procedure of the urinary tract such as turp, laser prostatectomy, photovaporization of the prostate 7. no minimally invasive surgery to the prostate such as tumt or tuna within the last 6 months. 8. active urinary tract infection. 9. unstable or uncontrolled medical or psychiatric condition. 10. abnormal screening labs \> 2 times the upper limit of normal (uln) \[for all parameters other than those listed for exclusion criteria#3\] 11. myocardial infarction or cva within the past 90 days. 12. requiring ongoing administration of antibiotics, antifungals, antiviral, chemotherapy, steroidal or immunosuppressive treatments. 13. requiring chronic administration of aspirin at a dose \>81 mg/day. 14. known hypersensitivity to study drug ingredient(s) or allergy to berries. 15. use of the following medications: alpha blockers (28 days of screening), herbal or nutritional bph supplements (28 days of screening), oab medications (28 days of screening), 5 alpha reductase inhibitors (175 days of screening), pde5 inhibitors (permitted as needed for erectile dysfunction only, but not to exceed 1 dose per week and not to be dosed within 5 days of a visit) 16. use of an investigational agent (drug, biologic, device, etc.) within 30 days of screening 17. any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.
adjusted steroids therapy in childerens with idiopathic nephrotic syndrome

Conditions: Nephrotic Syndrome, Minimal Change

Summary: the initial steroids dose for nephrotic syndrome is 60mg/1m2 for 6-4 weeks and the duration of the first steroid course is between 8 weeks to 6 months. the base of the initial dose for steroids idiopathic nephrotic syndrome been put in the early 70s. in our study the investigators will adjusted the first steroids does to the response day. our primary end point is : a lower adjusted dose is as good as the fix dose in the first year after diagnosis.

about 90% of the patients will response to steroid therapy. the initial steroid dose is between 2mg/kg or 60mg/1m2 for 6-4 weeks and the duration of the first steroid course is between 8 weeks to 6 months. the bases of this treatment have been put in the early 70s. since then most of the study were focused on the duration of the therapy with a results that 8-12 weeks course is as good as 6 month. studies have showed no difference in response rate between 2mg/kg to 60m2' although the difference in the dose in young children can rich to 25%. other retrospective analysis been show that patients who response in the first 7-9 days tend to have lass relapses than other patients. in our nephrology clinic the investigators there is ongoing clinical study on low doses of steroid therapy for relapse of nephritic syndrome with good results.

Eligibility criteria:
inclusion criteria: * children who recently have been diagnosed with nephrotic syndrome. exclusion criteria: * children with nephrotic syndrome that can not be treated with steroids.
examining effects of domain specific episodic future thinking on cannabis use

Conditions: Marijuana Use; Marijuana Dependence; Tobacco Use; Alcohol Use, Unspecified

Summary: the overarching goal of this online study is to compare the efficacy of six (weekly) sessions of domain-specific episodic future thinking (ds-eft) relative an active control condition on improving the ability to value future rewards and reducing cannabis use (grams and days of use), tobacco use, and alcohol use among.


Eligibility criteria:
inclusion criteria: * at least 18 or older * reside in the u.s. * report wanting to reduce cannabis use (4 or higher on scale of 1-10 with higher scores indicating greater desire to reduce use) * report using cannabis at least 10 days in the last month * report using cannabis at least 100 days in their lifetime * data quality checks passed exclusion criteria: -
role of vit-d supplementation on biontech, pfizer vaccine side effect and immunoglobulin g response

Conditions: COVID-19 Respiratory Infection

Summary: the goal of this clinical trial study is to investigate the role of anthropometric indices and vit-d supplementation on biontech, pfizer vaccine side effect and immunoglobulin g response against sars-cov-2 in individuals infected with covid-19. the main question\[s\] it aims to answer are: 1. bmi has role in reduce biontech, pfizer vaccine side effect 2. bmi has role in improve igg titer 3. vit-d supplementation has role in reduce biontech, pfizer vaccine side effect 4. vit-d supplementation has role in improve igg titer

the intervention group received 600iu of vitamin d supplements every day, one hour after breakfast, for 14-16 weeks. the control group took a placebo prepared with the same shape and size of supplements. the supplement was given to the patients by someone other than the researcher, to ensure that the researchers did not know which group receiving the supplement/placebo (given the double-blindness of the study). also, in this study, the person who did the data analysis did not aware of randomization. at first, a 3-day recall food questionnaire was taken from two groups. from the day, the subjects tested positive, they were asked to start supplementation for 4 weeks and return after that to take the first dose of the vaccine. subjects were asked to continue to use supplements after the first vaccination. after 6 to 8 weeks, patients came back for another vaccination dose and were again asked to use the supplement for 4 weeks again, after that subjects were asked to come for a blood test.

Eligibility criteria:
inclusion criteria: participants with covid-19 positive tests. exclusion criteria: 1. who did not take the vaccine 2. who take one dose of the vaccine 3. who did not come back for another dose 4. subjects who in the last 6 months received vitamin or mineral supplementation 5. those with chronic conditions such as diabetes, hypertension, and heart disease, unwillingness to continue the study protocol, lactating women and pregnant women.

Keywords: vitamin d, immunoglobulin g, covid-19 vaccine, side effects
study of imovax polio® subcutaneous as a booster vaccine in pre-school age children in japan

Conditions: Poliomyelitis; Polio

Summary: the aim of the study is to assess the immunogenicity of sp059 (imovax polio®: inactive poliovirus vaccine) vaccine against poliovirus and safety after fifth dose. primary objective: * to investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with sp059 as 2nd booster secondary objectives: * to investigate seroprotection rates (percentage of subjects presenting poliovirus neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points, geometric mean titers (gmt) at pre- and post-booster time points and geometric mean of individual titer ratio (gmtr). * to investigate the safety after dosing of sp059 as 2nd booster.

participants will receive one dose of sp059 (at visit 1) as a booster vaccination at an age from 4 to 6 years. they will be assessed for immunogenicity at baseline (pre-vaccination) and at 4-6 weeks post- vaccination. safety data including serious adverse events (saes) after vaccination will be collected during the study period.

Eligibility criteria:
inclusion criteria: * aged 4 to 6 years inclusive on the day of inclusion * subjects who received 4 times an ipv-containing vaccine (dtap-ipv or ipv) during first (3 doses) and second year of life (one dose) * informed consent form signed by the parent(s) or other legal representative * able to attend all scheduled visits and to comply with all trial procedures. exclusion criteria: * fever ≥ 37.5°c (axillary temperature) on the day of inclusion * any serious disease whether acute or chronic * past or current medical history of guillain-barre syndrome, acute thrombocytopenic purpura or encephalopathy * history of poliomyelitis infection * history of a life threatening reaction to a vaccine containing the same substances of the study vaccine * history of anaphylaxis or allergy to any of the study vaccine components * congenital or current/previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy * participation in another clinical trial within 6 months before the trial inclusion * planned participation in another clinical trial during the present trial period * received oral or injected antibiotic therapy within the 72 hours prior to any blood draw * received antipyretics/analgesics/non-steroidal anti-inflammatory drugs (considered as a single category) within 4 hours prior to vaccination * blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins) * any vaccination with live vaccines within the past 27 days preceding the trial vaccination * any vaccination with inactivated vaccines within the past 6 days preceding the trial vaccination * clinical or known serological evidence of systemic illness including hepatitis b, hepatitis c and/or hiv infection * subject ineligible according to the investigator's clinical judgment.

Keywords: poliomyelitis poliovirus polio imovax polio® inactivated polio vaccine
a study to evaluate safety and tolerability of iv or sc dose of medi-545 in patients with systemic lupus erythematosus.

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of the study is to evaluate the safety and tolerability of medi-545 in japanese adult sle patients. this will be done by collecting the data from 3 cohorts of iv doses and 1 cohort of sc doses.


Eligibility criteria:
inclusion criteria: * patients must have previously met ≥4 of the 11 revised acr criteria * have positive antinuclear antibody test (ana) at ≥1:80 serum dilute in the past or at screening * have at least 1 system with a score of a or 2 systems with a score of b on the bilag index at screening, or have a selena-sledai score ≥6 exclusion criteria: * have received prednisone \>20 mg/day (or an equivalent dose of another oral corticosteroid) within 14 days before visit 2 (day 1) * have received the following medications within 28 days before visit 2 (day 1): * systemic cyclophosphamide at any dose * cyclosporine at any dose * tacrolimus at any dose * thalidomide at any dose * mycophenolate mofetil \>2 g/day * methotrexate \>15 mg/week * azathioprine \>2 mg/kg/day * women who have a positive pregnancy test (serum hcg) at visit 1

Keywords: systemic lupus erythematosus japanese phase 2 safety tolerability medi-545 autoimmune disease immune system diseases
a study of lebrikizumab in combination with topical corticosteroids in patients with atopic dermatitis (ad) that are not adequately controlled with or are non-eligible for cyclosporine

Conditions: Dermatitis, Atopic; Eczema

Summary: the main purpose of this study is to evaluate the efficacy of lebrikizumab compared with placebo in participants not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable up to week 16.


Eligibility criteria:
inclusion criteria: * adults and adolescents (aged greater than or equal to (\>=) 12 to \ =40 kilograms). * chronic ad that has been present for \>=1 year before the screening visit. * easi score \>=16 at the baseline visit. * iga score \>=3 (moderate) (scale of 0 \[clear\] to 4 \[severe\]) at the baseline visit. * \>=10% bsa of ad involvement at the baseline visit. * inadequate response to existing topical medications * failure to cyclosporine or non-medically advisable to receive/continue receiving cyclosporine * signed icf (and informed assent for adolescents as required) exclusion criteria: * treatment with tcs within 1 week before the baseline visit. * treatment with topical calcineurin inhibitors, phosphodiesterase-4 inhibitors such as crisaborole, or cannabinoids within 2 week before the baseline visit. * treatment with interleukin 4 (il-4) or interleukin 13 (il-13) antagonists biological therapies before the baseline visit. exception: previous treatment with dupilumab will be allowed in a subset of patients * treatment with immunosuppressive/immunomodulating drugs, phototherapy and photochemotherapy within 4 weeks before the baseline visit * uncontrolled chronic disease that might require bursts of oral corticosteroids * serious, opportunistic, chronic or recurring infections within 3 months of screening or before randomization * current or chronic infection with hepatitis b virus, current infection with hepatitis c virus, known liver cirrhosis and/or chronic hepatitis of any etiology * known or suspected history of immunosuppression, history of hiv infection or positive hiv serology at screening * any clinically significant laboratory test results obtained at the screening visit * presence of skin comorbidities that may interfere with study assessments * have had an important side effect to tcs that would prevent further use.

Keywords: topical corticosteroids cyclosporine