Kornimate/medical-research-clean huggingface dataset:
comparing the incidence of preeclampsia between pregnant women receiving tdap vaccinations at week 28 or at week 36

Conditions: Pre-Eclampsia; Diphtheria, Tetanus and Pertussis Vaccine Reaction

Summary: preeclampsia is a significant medical condition occurring in 3-8% of pregnancies and impacts deleteriously both maternal and fetal health. an important discovery has been made by dr craig d scoville showing that early tdap vaccinations in pregnancy can reduce the incidence of preeclampsia by more than 50%. a prospective clinical research trial is proposed and urgently needed to validate this finding and thereby make a significant contribution in reducing the incidence of this common and severe complication of pregnancy.

a double blinded randomized prospective clinical research study is proposed to validate the hypothesis that tdap vaccinations at week 28 in pregnancy can reduce the incidence of preeclampsia by more than 50%. this project will recruit 1600 pregnant women with appropriate informed consent in the first trimester of pregnancy, obtain detailed obstetric and health history, and then randomize these subjects so 800 women receive tdap at week 28, and 800 women receive tdap at week 36, and all women will be followed during their pregnancies using standard of care with special attention to preeclampsia and fetal outcomes. blood samples will be obtained at weeks 12, 20, and 36 in order to test the anti-tetanus toxoid antibody levels, anti-diptheria antibody levels, anti-pertussis antibody levels, and also maternal cytokines (il-2, il-4, il-6, il-10, tnfa, il-17, and ifng), and placental biomarkers (sflt-1, seng, and pigf) for preeclampsia on those patients who develop preeclampsia and compare to those who didn't and thereby better understand the biomarkers of preeclampsia and devise a better formula for positive prediction for preeclampsia. to make this change in clinical practice and save lives, this study is asking for funding from nichd pa-18-480.

Eligibility criteria:
inclusion criteria: 1. confirmed pregnancy at week 12 2. age 18 to 42 3. willing to participate and sign informed consent documentation 4. willing to follow study procedures with regards to randomization of tdap and attend all routine clinic visits per obstetrician and standard of care 5. accept tdap vaccination either at week 28 or week 36 exclusion criteria: 1. no history of allergic reaction or intolerance to tdap vaccination 2. no history of cancer in past 5 years prior to this study (except for non melanoma localized skin cancers or cancer in situ) -

Keywords: preeclampsia tdap vaccinations
lmx-4 for postoperative pain management in infants and children undergoing penoplasty surgery

Conditions: Post-Operative Pain

Summary: after surgery on his penis, your child will probably have some pain. the investigators will give you a prescription for acetaminophen (tylenol) with codeine, given by mouth (orally), for pain. in this study, the investigators want to see if a local anesthetic cream applied to the base of the shaft of the penis can reduce the need for oral medicine .

your child will receive a general anesthetic for the surgery. after your child is asleep, he will receive a local anesthetic injection in the area of the tailbone (normal procedure for this surgery). at the end of the operation your child will go to the recovery room. at the time of discharge from the hospital, we will be give you the prescription for acetaminophen with codeine (standard medication given for children undergoing surgery on the penis), and a tube of cream. the tube will contain either a local anesthetic cream (lmx-4)® or a cream with no active medicine (a placebo). we want you to apply the cream to the base of your son's penis every six hours. which kind of tube you get will be picked randomly (similar to drawing numbers out of a hat) by a computer. thirty minutes after applying the study cream, or sooner if needed, if you think your child needs pain medication, you may give the oral pain medicine (tylenol with codeine as prescribed on the bottle). you may continue to apply the cream and give oral medicine every six hours as long as you think your child needs pain medicine for a maximum of 7 days. the cream can also be re-applied when changing diapers to facilitate the continued use of the cream even if it is sooner than the suggested 6 hours.

Eligibility criteria:
inclusion criteria: * subject is 3 months to less than 3 years of age (at least 3 months old but not yet reached his 3rd birthday at the time of enrollment). * subject has presented with a clinical diagnosis of buried penis * with the exception of the disease being studied, subject is in good health in the opinion of the investigator. * subject and parent(s) or legal guardian(s) must agree to the requirements and restrictions of the study and will appear for all required examinations. * subject's parent or legal guardian must sign a written, irb-approved informed consent prior to admission into the study, and must be able to understand that consent form. exclusion criteria: * subject has a known hypersensitivity to any component of the study medication. * subject has history or evidence of other conditions that would interfere with evaluation of the study medication. * subject has been treated with another investigational device or drug within 30 days prior to study enrollment, or is participating in a clinical trial at the time of enrollment or intends to participate in a clinical trial concurrent with this study.
the impact of hypoxia on the biochemical and morphological parameters of blood in rowers.

Conditions: Hypoxia

Summary: the response to hypoxia is very individual and epending on many aspects, such as the type of training, duration, intensity, or hypoxic stimulus, hypoxia affects the athlete in various ways. the results of this study have shown that 18 days of the lh-tl method does not significantly increase the level of epo and vegf in rowers. however, reticulocytes, immature red blood cells, have shown significant differences after 18-d lh-tl between groups. further research should be carried out to investigate an optimal hypoxic dose and time, which will raise epo, vegf, and morphology variables.

the polish national rower team athletes, 13 males (ages 27,0±4,2 years), were randomly divided into two groups: 1) the hypoxic group (h) included 8 rowers participating in sports training and the lh-tl method, hypoxic rooms (fio2=14.5%, corresponds to an altitude of 3000 meters). 2) the control group (c) presented 5 rowers participating only in sports training and living in normoxic rooms, at the same sports camp. rowers were observed during the preparatory period. the hypoxic group lived and slept in hypoxic rooms, for at least 8-14 hours per day. during the camp, all rowers followed the same training schedule and diet.all participants' saturation and heart rate were measured daily, morning and evening, throughout the camp period. venous blood samples were taken four times, at the beginning of the camp (baseline), after 5 days, after 12 days, and after 18 days of the camp. body composition parameters such as body mass index, body fat, and free fat mass were estimated using the bioelectrical impedance method of an analyzer tanita bc 418 (japan). data analysis was performed using statistica. the response to hypoxia is very individual. depending on many aspects, such as the type of training, duration, intensity, or hypoxic stimulus, hypoxia affects the athlete in various ways. the results of this study have shown that the blood parameters did not increase significantly in the hypoxic group compared to the control group. however, reticulocytes, immature red blood cells, have shown significant differences after 18-d lh-tl between groups. further research should be carried out to investigate an optimal hypoxic dose and time, which will raise epo, vegf, and morphology variables.

Eligibility criteria:
inclusion criteria: * member of national rower's teams, and sports camp participant. exclusion criteria: * negative symptoms of hypoxia, and/or injury.

Keywords: hypoxia rowers exercise epo athletes lh-tl
a study to compare the bioavailability of copegus and vilona® in healthy volunteers

Conditions: Healthy Volunteer

Summary: this prospective, randomized, single-blind, cross-over study will compare the bioavailability of copegus (ribavirin) administered as tablets and ribavirin administered as capsules in healthy volunteers. volunteers will be randomized to receive a single dose of 400 mg of ribavirin either as a capsule or as tablets; after a washout phase volunteers will be crossed-over to the other treatment. the anticipated time on study treatment is 10 days.


Eligibility criteria:
inclusion criteria: * adult healthy volunteers, 18 to 55 years of age * clinically healthy as confirmed by medical history, physical examination, electrocardiogram, thorax teleradiography and routine clinical laboratory measurements * body mass index between 18 and 28 kg/m2 * negative testing for drugs of abuse exclusion criteria: * history or presence of any clinically significant condition that might interfere with the pharmacokinetics of the study drugs * volunteers require co-medications during the study * exposure to agents known as inducers or inhibitors of hepatic enzymatic system within 30 days prior to study start * having taken any medication with a clearance period of over seven half-life before study start * hospitalization or significant illness 30 days before study start * having received a investigational drug within 90 days prior to study start
treatment of patients with diabetic kidney disease

Conditions: Diabetic Kidney Disease

Summary: due to irrespective of the limitations associated with estimated glomerular filtration rate (egfr), it is crucial to develop new treatments that can effectively address these concerns. so, this study aimed to compare the effectiveness of sglt2i versus acei in the progression of diabetic kidney disease including progression of albuminuria. doubling of serum creatinine and need for renal replacement therapy

diabetic kidney disease (dkd) is the leading cause of end stage renal disease (esrd) worldwide and continues to be the major contributor to kidney replacement therapy (krt). despite the significant decline in diabetes-related complications in recent decades, the same trend cannot be observed in chronic kidney disease (ckd) patients due to dkd that requires krt. hence, there exists a significant requirement for novel treatment approaches that can enhance glycemic control while minimizing the risk of hypoglycemia, as well as reducing cardiovascular and renal risks within this population. irrespective of the limitations associated with estimated glomerular filtration rate (egfr), it is crucial to develop new treatments that can effectively address these concerns. ace inhibitors may delay the progression of nephropathy and reduce the risks of cardiovascular events in hypertensive patients with diabetes mellitus type i and type ii. sglt2i have become the new standard of care for slowing ckd progression in patients with type 2 diabetes mellitus (t2dm, due to their specific renal and cardiovascular protective effects that are independent of the main metabolic and glucose-lowering effects. research questions: q1. is there a significant effect of acei in treatment of patients with diabetic kidney disease. q2: is there is a significant effect of sglt2i in treatment of patients with diabetic kidney disease. q3: which is more significantly efficient in treatment of patients with diabetic kidney disease (acei versus sglt2i)

Eligibility criteria:
inclusion criteria: * patients that suffer from diabetic kidney disease (dkd) exclusion criteria: * genital mycotic infections * urosepsis and pyelonephritis * lower limb amputation * diabetic ketoacidosis * euglycemic dka * acute kidney injury * hypoglycemia * fournier gangrene * hypersensitivity reactions * bone fracture * bladder cancer * hyperkalemia * dyslipidemia

Keywords: efficacy of acei versus sglt2i
virtual group motivation in exercise treadmill testing

Conditions: Exercise Test

Summary: exercise stress testing is the most frequently used clinical tool for assessment of coronary artery disease. to ensure a high validity of the results, a good patient compliance is crucial. the aim of this study is to examine the effects of a virtually presented exercise group on the perceived comfort and the exercise capacity of patients during classical treadmill exercise testing. the investigators hypothesis is, that a virtually presented running group will increase the comfort of patients and their exercise capacity.

108 patients were randomized in an open label trial 1:1 to either exercise treadmill testing while watching a static image of a flower (image group) or to exercise treadmill testing while watching a video of 5 amateur runners, running across and fields, giving the patient the impression of running within the group (video group). after the exercise test patients were asked to score their perceived comfort level and achieved level of their subjective physical limit on a 10 point scale. standard exercise treadmill parameters, as well as baseline demographic data were recorded of each patient. patients with missing data was excluded of the analysis. statistic analysis was performed with t-test for normally distributed data and wilcoxon-mann-whitney-test for non-normal data.

Eligibility criteria:
inclusion criteria: * indication for exercise stress testing exclusion criteria: * any contraindication for exercise stress testing * unability of performing an exercise treadmill test * recent surgery

Keywords: exercise testing coronary artery disease virtual group motivation
calcitriol in the treatment of immunoglobulin a nephropathy

Conditions: Glomerulonephritis; Autoimmune Diseases

Summary: immunoglobulin a (iga) nephropathy is the common primary glomerulonephritis in the world. much literature suggests that vitamin d and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy of calcitriol in the treatment of iga nephropathy. forty patients with biopsy-proven iga nephropathy will be recruited. they will be randomized to calcitriol for six months or no treatment. proteinuria, renal function, serum and urinary inflammatory markers will be monitored. this study will explore the potential anti-proteinuric and anti-inflammatory effects of calcitriol in the treatment of iga nephropathy, which has no specific treatment at present.


Eligibility criteria:
inclusion criteria: * aged 18-65 years * biopsy-confirmed iga nephropathy * proteinuria \> 0.8 g/day in 3 consecutive samples within 12 weeks despite ace inhibitor or angiotensin receptor blocker treatment for at least 3 months or estimated glomerular filtration rate \< 60 ml/min/1.73m2 * corrected serum calcium level \< or = 2.45 mmol/l * willingness to give written consent and comply with the study protocol exclusion criteria: * pregnancy, lactating or childbearing potential without effective method of birth control * severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication * history of malignancy, including leukemia and lymphoma within the past 2 years * systemic infection requiring therapy at study entry * any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension * history of drug or alcohol abuse within past 2 years * participation in any previous trial on paricalcitol * patients receiving treatment of vitamin d and/or its analogue for other medical reasons within the past 3 months * patients receiving treatment of corticosteroid * on other investigational drugs within last 30 days * history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study * history of non-compliance * known history of sensitivity or allergy to paricalcitol or other vitamin d analogs

Keywords: immunoglobulin a antibodies treatment
safety, tolerability, and efficacy of zilucoplan in subjects with generalized myasthenia gravis

Conditions: Myasthenia Gravis, Generalized

Summary: the raise study is a multicenter, randomized, double-blind, placebo controlled study to confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized myasthenia gravis. subjects will be randomized in a 1:1 ratio to receive daily sc doses of 0.3 mg/kg zilucoplan or placebo for 12 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of gmg \[myasthenia gravis foundation of america (mgfa) class ii-iv\] at screening * positive serology for acetylcholine receptor (achr) autoantibodies * mg-adl score of ≥ 6 at screening and baseline * qmg score ≥ 12 at screening and baseline * no change in corticosteroid dose for at least 30 days prior to baseline or anticipated to occur during the 12-week treatment period * no change in immunosuppressive therapy, including dose, for at least 30 days prior to baseline or anticipated to occur during the 12-week treatment period exclusion criteria: * thymectomy within 12 months prior to baseline or scheduled to occur during the 12 week treatment period * history of meningococcal disease * current or recent systemic infection within 2 weeks prior to baseline or injection requiring intravenous (iv) antibiotics within 4 weeks prior to baseline
switching study from lamivudine to clevudine in the chronic hepatitis b patients

Conditions: Chronic Hepatitis B

Summary: a multi-center and open study to compare the safety and effectiveness of switching treatment from lamivudine to clevudine for 24 weeks.


Eligibility criteria:
inclusion criteria: * hbv dna \> 2,000 copies/ml at screening * patients who have compensated liver disease (child-pugh score =\<6) * patients without lmv resistant mutation by rfmp assay * patients who have not experienced viral breakthrough at consecutive two measurements (at least one month apart) during lamivudine monotherapy * patients who can submit the written consent and comply with the claims postulated of this clinical trial exclusion criteria: * currently receiving antiviral except lmv or corticosteroid therapy * patients that previously received antiviral treatment for hepatitis b other than lamivudine in the proceeding 12 months * previous treatment with interferon or other immunomodulatory therapies must have ended at least 6 months preceding the study screening * treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period * patients who is co-infected with hcv, hdv or hiv * serious concurrent medical conditions * prior organ transplantation * patient has creatinine clearance less than 60ml/min as estimated by the following formula: \[(140-age in years) (body weight \[kg\])\] / \[(72) (serum creatinine\] \[mg/dl\])\[note: multiply estimates by 0.85 for women\]
metformin reduces left ventricular mass in patients with ischemic heart disease

Conditions: Left Ventriclar Mass

Summary: cardiovascular disease is the most common cause of death in the world. most of the attention in treating ischemic heart disease (ihd) is understandably directed toward treating coronary artery disease. however there are other treatable culprits in these patients. left ventricular hypertrophy (lvh) is widespread in ihd patients, even in the absence of hypertension. it is a strong predictor of cardiovascular events and all-cause mortality. in one study, the presence of lvh was a stronger predictor of mortality than either multivessel cor-onary disease or impaired lv function. metformin is an antihyperglycemic agent with a history of successful use in type 2 diabetes. in the ukpds (united kingdom prospective diabetes study), metformin was associated with a 39% lower risk of myocardial infarction compared with conventional therapy. metformin also offered dual benefits of improving vascular function and lessening ischemia in nondiabetic patients. hence, the main aim of this study was to assess whether metformin could regress lvm in patients with ihd. the secondary aim was to assess the effect of metformin on lv volumes and endothelial function in this patient group.


Eligibility criteria:
inclusion criteria: * they had to have normal glucose tolerance. * they had to have either angiographically documented coronary artery disease or a previous history of myocardial infarction. * they were required to have an office bp \< 130/80 mm hg * the presence of lvh on echocardiography (american society of echocardiography criteria lvm index \[lvmi\] \> 115 g/m2 for men and \> 95 g/m2 for women). exclusion criteria: * they were currently prescribed metformin. * they had renal and liver dysfunction, heart failure, or malignancy, or were unable to give informed consent. * patients with contraindications to cardiac magnetic resonance (cmr) (pacemakers, claustrophobia) were also excluded, as were pregnant or lactating women.

Keywords: metformin left ventricular mass endothelial dysfunction cardiac magnetic resonance aortic pulse wave
safety, tolerability, pharmacokinetics and pharmacodynamics of amg 139 in healthy subjects and subjects with moderate to severe psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to assess the safety and tolerability of amg 139 following single subcutaneous (sc) or intravenous (iv) dose administration in healthy subjects and subjects with moderate to severe psoriasis (pso).


Eligibility criteria:
inclusion criteria: part a - healthy volunteers: * healthy male or female of non-reproductive potential subjects between 18 to 45 years-of-age * body mass index (bmi) between 18 and 32 kg/m2 * normal or clinically acceptable physical examination, clinical laboratory values, and ecg * additional inclusion criteria apply part b - psoriasis subjects: * male or female of non-reproductive potential subjects with pso between 18 to 55 years-of-age * body mass index (bmi) between 18 and 32 kg/m2 * normal or clinically acceptable physical examination (pe), clinical laboratory values, and ecg; clinically acceptable pe includes evidence of moderate to severe plaque pso * diagnosis of plaque pso for at least 6 months * moderate to severe plaque pso defined by: * a minimum pasi score of ≥ 10 * psoriasis involving ≥ 10% of the body surface area (bsa) * additional inclusion criteria apply exclusion criteria: parts a - healthy volunteers: * history or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion; * recent or on-going infection(s) * underlying condition(s) that predisposes the subject to infections * history of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers in past 5 years * additional exclusion criteria apply part b - psoriasis subjects: * history or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion; * recent or on-going infection(s) * underlying condition(s) that predisposes the subject to infections * guttate, pustular, or other non-plaque forms of pso * evidence of skin conditions other than pso (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis * history of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers in past 5 years * additional exclusion criteria apply

Keywords: amgen amg 139