Kornimate/medical-research-clean huggingface dataset:
antenatal betamethasone and the risk of neonatal hypoglycemia

Conditions: Hypoglycemia

Summary: a single "supraphysiological" course of exogenous corticosteroids is recommended between 24-34 weeks' gestation to minimize the adverse sequelae associated with prematurity. the 24-hour profile of endogenous corticosteroids normally follows a diurnal rhythm with the highest serum level occurs between 5am-11am and nadir over 12 hours.

a retrospective study from january 2010 to december 2017. eligible for analysis are: singleton pregnancies between 24 - 34 weeks' gestation who were given a single course of intramuscular betamethasone. single course comprised of two separate doses of 12 mg given 24 hours apart. each woman was allocated into one of the four pre-defined groups based on the time the intramuscular betamethasone was administered; group 1 (5am-11am), group 2 (11am-5pm), group 3 (5pm-11pm) and group 4 (11pm-5am). the investigators hypothesized that exogenous corticosteroids given during the nadir state of endogenous corticosteroids activity could alter maternal and fetal glucose homeostasis.

Eligibility criteria:
inclusion criteria: • women between 24 - 34 weeks' gestation who were admitted and given a single course of intramuscular betamethasone for threatened preterm labor in our institution exclusion criteria: * higher order multiple pregnancies * women who were given more than one course of betamethasone during the course of the current pregnancy * known major congenital anomalies.
a multiple-ascending-dose study of the safety and tolerability of regn421(sar153192) in patients with advanced solid malignancies

Conditions: Advanced Solid Malignancies

Summary: the purpose of this study is to assess the safety and tolerability of regn421 (sar153192) in patients with advanced solid malignancies.


Eligibility criteria:
inclusion criteria: 1. male or female 18 years of age or older 2. histologically diagnosis of advanced solid malignancy, with no standard therapeutic options of proven benefit. 3. patients with measurable or non-measurable disease 4. at least 6 weeks must have elapsed since the last dose of bevacizumab (avastintm) 5. at least 4 weeks must have elapsed since the last major surgery 6. for women of childbearing potential, a negative urine pregnancy test at the screening visit 7. willingness to use adequate contraception during the full course of the study. systemic hormonal contraceptive agents are excluded 8. willing, committed, and able to return for all clinic visits and complete all study-related procedures. 9. able to read, understand and willing to sign the informed consent form exclusion criteria: 1. medical history of myocardial infarction or cardiomyopathy 2. unstable angina 3. nyha class ii - iv congestive heart failure 4. patients under treatment with more than 2 antihypertensive medications 5. history of bleeding peptic ulcer disease, erosive gastritis, intestinal perforation, or clinically significant gi hemorrhage within 6 months of study drug administration 6. diabetic retinopathy 7. patients requiring anticoagulation 8. hypersensitivity to doxycycline or related compounds
monitored effects of physical activity on fetal heart rate by using a wireless non-invasive device

Conditions: Fetal Distress

Summary: effect of acute exercise testing in pregnant athletes on maternal and fetal heart rate, fetal/maternal bloodflow and cardiotocogramm assessment.

the aim of the study is to evaluate in a preliminary step the validity of fetal heart rate measurement with the "nemo healthcare monitoring system" - a wireless non-invasive ctg device. furthermore, we will determine the reliability for ctg measurements (intraobserver and interobserver reliability) and for ultrasound (intraobserver reliability). the device is approved for use on pregnant women and is regularly used as a ctg device for monitoring fetal heart rate and contractions during childbirth. if in the preliminary step the heart rate measurements with the "nemo fetal monitoring system" provide valid and fetal heart rate results compared to the standard doppler ultrasound method and provide a reliable detection of fetal heart rate deceleration the effects of phys-ical activity on fetal heart rate pattern and changes in fetal blood flow, placento-fetal and materno-placental blood supply rate will be investigated in the main part of the study in a larger study population. it is hypothesized that ctg provides technically a valid and reliable continuous re-cording of fetal heart rate values, since fetal heart rate measurement under physical exertion has previously only been possible by intermittent but not continuous dop-pler ultrasound. furthermore, we will evaluate alterations in fetal heart rate pattern and changes in fetal blood flow, placento-fetal and materno-placental blood supply according to the level of exertion.

Eligibility criteria:
inclusion criteria: * presence of signed informed consent form * healthy pregnant active female over the age of 18 years and below 45 years * sporting activity \>4h/week on 2 or more weekdays * single pregnancy, between 28+0 and 34+0 weeks of pregnancy exclusion criteria: * no signed informed consent form or revocation of consent * pre-existing pregnancy complications
the acute burn resuscitation multicenter prospective trial

Conditions: Burn Injury

Summary: this is a prospective randomized multi-center study which will compare acute fluid resuscitation using a colloid strategy (lr + 5% albumin) to a crystalloid strategy (lr alone), in adults with an acute burn involving at least 25% of their total body surface area.

enrolled subjects will be randomly assigned to either the colloid group or the crystalloid group. randomization will be based on an intent-to-treat basis. in order to ensure that the two groups have comparable injury severity at baseline, randomization will be block- stratified based on age (18-50 and \> 50 years), burn size (25-50% and \> 50% tbsa), and presence of inhalation injury confirmed by bronchoscopy (present or absent). in the colloid group resuscitation starts with lr and then 5% albumin will be introduced between 8 and 12 hours post burn in a ratio of 1/3 albumin to 2/3 lr. in the crystalloid group resuscitation is with lr only. each group will have their study fluid maintained for the 1st 48 hours post burn and study fluids in each group will be identically titrated to the urinary output.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * total burn size (second and third degree) is ≥ 25% of the tbsa * burn center admission within 12 hours of injury. * there is a plan for formal fluid resuscitation. exclusion criteria: * significant associated trauma * high voltage (≥ 1000 volts) electrical burns * burn wound excision surgery within 48 hours from injury * fresh frozen plasma (ffp) given at any time ≤ 48 hours from injury * hypertonic saline (hts) given at any time ≤ 48 hours from injury * hydroxyethyl starch (hes) given at any time ≤ 48 hours from injury * high dose vitamin c infusion given at any time ≤ 48 hours from injury * administration of human albumin prior to randomization * palliative comfort measures are instituted ≤ 48 hours from injury * pregnancy * pre-injury chronic renal insufficiency equal to or greater than stage 3 * pre-injury chronic hepatic disease (child-pugh b or c) * pre-injury left ventricular (lv) dysfunction (echocardiography lv grade ii-iv or ejection fraction ≤ 35%)

Keywords: resuscitation
taking care of us: a dyadic intervention for heart failure couples

Conditions: Heart Failure

Summary: this research study is evaluating the efficacy and feasibility of a novel, dyadic intervention for heart failure couples versus an educational counseling intervention.

there is a critical need for theoretically- and empirically-driven dyadic interventions to improve the outcomes of both adults with heart failure and their partners. the proposed study will evaluate a novel, dyadic program, taking care of us, versus an educational counseling condition using a randomized controlled trial on 72 couples living with heart failure. both programs are offered via zoom by trained interventionists and last approximately two months. specifically, we will 1) determine the efficacy of the taking care of us intervention on dyadic health; 2) determine the efficacy of the taking care of us intervention on dyadic appraisal and dyadic management; and 3) determine the feasibility and acceptability of the taking care of us intervention.

Eligibility criteria:
inclusion criteria: adults with heart failure: * diagnosis of heart failure for at least three months * current heart failure symptoms (i.e., nyha class ii-iii; aha/acc stage c) * age greater than or equal to 18 years * willing and able to provide informed consent * reachable by telephone/email * access to device with camera (e.g., computer, tablet) to participate in zoom sessions * have a co-residing spouse/unmarried partner willing to participate inclusion criteria: spouses/partners: * age greater than or equal to 18 years * co-residing with the adult with heart failure at time of recruitment * have lived with the adult with heart failure for at least one year * willing and able to provide informed consent exclusion criteria: * major and uncorrected hearing impairment * significant cognitive impairment * heart transplantation/mechanical circulatory support prior to enrollment * concomitant terminal illness that would impede participation * active psychosis or severe substance abuse that would impair the ability to complete the study * inability to complete the requirements of the study, including enrolment in an additional trial

Keywords: couples spouses dyads
idiopathic scoliosis and orthodontic treatment

Conditions: Idiopathic Scoliosis

Summary: scoliotic pathology remains to this day little known, on the one hand in its etiologies but also in its various implications and possible associations. one of the notable questions found in the literature is concerned with the link between idiopathic scoliosis and the stomatognathic system. this question arises from the study of the anatomy and function of its two entities. the aim of the study is to determine the frequency of orthodontic treatment in adolescents with idiopathic scoliosis, and to compare it with that of adolescents without spinal dysmorphism.


Eligibility criteria:
inclusion criteria: * adult and child (age ≥ 12 years) * be carriers of idiopathic scoliosis confirmed by x-ray. * have reached bone maturity (risser 4 and more) * adult who has not expressed, after information, the reuse of his data for the purposes of this research * - child and holders of parental authority who have not expressed, after information, the reuse of their data for the purposes of this research exclusion criteria: * refusal to participate in the study * association with another orthopedic pathology * adult patients under guardianship or crater or under the protection of justice

Keywords: idiopathic scoliosis orthodontic treatment spinal dysmorphism
a two week nitazoxanidebased quadruple regimen

Conditions: Dyspepsia

Summary: helicobacter pylori (h. pylori) infection is a global health problem as it is associated with peptic ulcers, chronic gastritis, duodenitis, and stomach cancer. therefore, the eradication of the pathogen is of critical importance to reduce h. pylori-related complications . however, due to increasing antibiotic resistance, eradication of helicobacter pylori has become more challenging. with a great decline in the eradication rate of standard triple therapy for helicobacter pylori to below 70% in many countries. treatment with triple therapy, which is the most frequently recommended, fails to eradicate h. pylori in approximately 20% of cases .

designing a new rescue regimen that achieves greater than 85% eradication rate is an important target of current research. unfortunately, the most frequently used "rescue" or "salvage" therapy is bismuth quadruple therapy consisting of a proton pump inhibitor (ppi), tetracycline, metronidazole, and bismuth \[11\]. this rescue therapy is inexpensive, and relatively effective with average eradication rate of 70% when used as second-line therapy. however, disadvantages of bismuth based quadruple therapy include the large daily number of pills (sometimes exceeding 18 pills), increased dosing frequency (four times daily), and frequent side effects.

Eligibility criteria:
inclusion criteria: * patients with helicobacter infection. * in whom the standard triple therapy (clarithromycin-based triple therapy) failed exclusion criteria: * patients under 18 or over 65 years of age. * those with co-existing serious illnesses such as liver cirrhosis, uremia and gastrointestinal malignancies * pregnancy/lactation * having contraindication or allergy to any of the study drugs
viral testing and biomarkers to reduce antibiotic use for respiratory infections

Conditions: Respiratory Infections

Summary: this trial is a pilot study to determine the feasibility of a randomized clinical trial comparing a treatment algorithm consisting of a limited number of clinical parameters, rapid molecular viral diagnostics, and serum procalcitonin testing to standard of care for directing antibiotic use in patients with non-pneumonic lower respiratory tract infection. the reduction in antibiotic use in those subjects randomized to the treatment algorithm compared to those randomized to standard care will be determined.

this is trial is a pilot study to determine the feasibility of a randomized clinical trial comparing a treatment algorithm consisting of a limited number of clinical parameters, rapid molecular viral diagnostics, and serum procalcitonin testing to standard of care for directing antibiotic use in patients with non-pneumonic lower respiratory tract infection. the reduction in antibiotic use in those subjects randomized to the treatment algorithm compared to those randomized to standard care will be determined. in addition, the added benefit of viral diagnosis to that of serum procalcitonin alone in reducing antibiotics will be determined. lastly, antibiotic related complications and clinical outcomes to determine the safety of this approach at 30 days and 3 months in the standard care and intervention group will be evaluated. analysis of the composite adverse event outcome (death, intensive care unit transfer, disease specific complications and recurrent respiratory tract infection requiring hospitalization) will serve as the principle safety analysis for the study. in addition, each adverse outcome will be examined individually as well as lesser adverse outcomes including antibiotic prescriptions, time to return to baseline health, patient reported outcomes and functional status at 30 days and 3 months. physicians will be queried to determine factors which drive antibiotic prescriptions and potential barriers to implementing antibiotic reduction algorithms. these data will be used to design a phase iii clinical trial with the intent to demonstrate that physicians in the us will respond appropriately to this information and that antibiotic use can be significantly and safely curtailed.

Eligibility criteria:
inclusion criteria: * hospitalized with symptoms of a respiratory infection * age \> 21 years * systolic blood pressure \> 90mm hg * patient or health care designee can provide written informed consent exclusion criteria: * intensive care requirement * antibiotics received prior to admission * more than 24 hours of antibiotics received prior to enrollment * active chemotherapy or pulmonary radiation therapy * immunosuppressive conditions * conditions know to increase pct values * definite infiltrate on cxr •% of band forms in peripheral blood \> 15

Keywords: respiratory viruses bacterial antibiotics procalcitonin
sleep apnea, obesity and pregnancy

Conditions: Obesity; Pregnancy

Summary: main objective: determine the prevalence of obstructive sleep apnea syndrome (osa) in late pregnancy in a population of obese patients . secondary objectives : * identify risk factors for osa during pregnancy (age, parity, high blood pressure, snoring , weight, neck circumference, scores on symptoms of sleep apnea, ... ) . * compare perinatal morbidity among obese patients with osa in late pregnancy with case-controls. * evaluate the evolution of a moderate or severe osa 6 months after pregnancy. material and methods characteristics of the study: * interventional biomedical research * prospective multicenter nonrandomized study flow chart * patients will be included between 30 and 36 weeks of amenorrhea (wa) . * will rated from inclusion: age, parity, weight, height, bmi in early pregnancy, neck circumferrence, treated high blood pressure. * as recommended in france, the main test results during the pregnancy follow-up will be recorded. * at the inclusion visit will be conducted a berlin questionnaire and epworth score. * screening for osa by nocturnal polysomnography will be performed between 30 and 36wa. this screening can be performed as an outpatient. * in case of proven osa patients will be offered an appropriate care by today's standards. * whatever the outcome of pregnancy, a second polysomnography will be performed 6 months after childbirth in case of osa during pregnancy.


Eligibility criteria:
inclusion criteria: * bmi \>35 * pregnancy after 30 weeks of amenorhea * age \> 18 * signed consentment * nationnal health program affiliation exclusion criteria: * twin or more pregnancy * imprecise term * artificial insemination with donor gametes * proved thrombophilia * chronic renal failure * previously treated (with cpap) obstructive sleep apnea syndrom

Keywords: pregnancy (after 30 weeks of amenorhea) obesity (bmi>35) sleep apnea syndrom preeclampsy intrauterine growth restriction
study of bone marrow samples from patients with acute leukemia

Conditions: Leukemia

Summary: rationale: studying the genes expressed in samples of bone marrow from patients with cancer may help doctors identify biomarkers related to cancer. purpose: this research study is looking at bone marrow samples from patients with acute leukemia.

objectives: * to perform high throughput sequencing of a set of megakaryocyte specific transcription factors, tyrosine kinases, and src kinases in dna isolated from bone marrow specimens of adults with acute megakaryoblastic leukemia (amkl). * to assay the ability of src kinase inhibitors (su6656, dasatinib) to induce differentiation of amkl blasts in these patients. outline: dna from previously collected bone marrow samples are sequenced to analyze genes associated with transcription factors (gata1, gata2, scl, fog-1, ets1, ets2, erg, fli-1, gabp, hoxa11, nf-e2, and runx1), tyrosine kinases (jak2, jak3, and c-mpl), and src family kinases (lyn, fyn, and hck) and compared with control dna. using bioinformatics, gene alterations are compared to known polymorphisms and subsequent changes in the amino acid sequence of the encoded protein. subsequent assays assess the effect on proliferation and differentiation and in vitro studies evaluate the consequences of mutations on transcription factor and kinase activity abilities. the effect of su6656 and dasatinib on cell death and polyploidization is evaluated by flow cytometry and compared with control dna.

Eligibility criteria:
disease characteristics: * diagnosis of adult acute megakaryoblastic leukemia * archived bone marrow specimens from the ecog tissue repository patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: adult acute megakaryoblastic leukemia (m7)
safety and efficacy study of q301 in moderate to severe atopic dermatitis patients

Conditions: Moderate to Severe Atopic Dermatitis

Summary: this is a randomized, double-blind, vehicle-controlled, parallel-group comparison study to evaluate the safety and efficacy of q301 cream vs. vehicle in adult subjects with moderate to severe ad. study drug (q301 cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.


Eligibility criteria:
inclusion criteria: 1. male or female subjects aged 18 or older 2. subjects with a clinical diagnosis of ad according to the hanifin and rajka criteria by a board certified/eligible dermatologist 3. subjects with iga score 3 or 4 corresponding to moderate to severe ad at screening and baseline visits exclusion criteria: 1. subjects who had topical treatment with corticosteroids within 1 week before randomization 2. subjects who had systemic treatment with corticosteroids or cyclosporine or other immunosuppressive treatment within 4 weeks before randomization 3. subjects who had ultraviolet irradiation (including photopheresis) within 4 weeks before screening 4. subjects who participated in another drug trial within 4 weeks before screening
the antidepressant effects of the nmda antagonist, cp-101,606, in patients with mdd

Conditions: Depressive Disorder, Major

Summary: to determine if the nmda antagonist, cp-101,606, is effective for depression


Eligibility criteria:
inclusion criteria: * primary dsm-iv diagnosis of mdd exclusion criteria: * subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of asc30 injection in participants with obesity

Conditions: Chronic Weight Management

Summary: this randomized, double-blind, placebo-controlled single ascending dose (sad)/ multiple ascending dose (mad) study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of asc30 injection


Eligibility criteria:
inclusion criteria: 1. have provided informed consent before initiation of any study-specific procedures. 2. male or female participants, non-smokers, between 18 and 65 years of age (both inclusive). 3. no clinically significant findings from medical history, physical examination, 12-lead ecg, vital signs measurements, and other screening procedures. exclusion criteria: 1. have evidence of any clinically significant active or chronic disease. 2. have any prior diagnosis of diabetes mellitus (t1dm or t2dm), or rare forms of diabetes mellitus. 3. have an autoimmune disease, is immunosuppressed or is in any way immunocompromised. 4. have a history of acute or chronic pancreatitis. 5. participants with a known clinically significant gastric emptying abnormality. 6. have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy. 7. have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol.