Kornimate/medical-research-clean huggingface dataset:
miscarriage preventing herbal medicines and the risk of birth defects: a population-based cohort study

Conditions: Pregnancy; Birth Defects; Drug Exposures

Summary: using data from a population-based medicine use cohort in xiamen, china, this retrospective cohort study will investigate whether herbal medicines used to prevent miscarriage are associated with increased risk of birth defects.

herbal medicines have a long history of use for pregnant women both in china and around the world. however, the safety of herbal medicines used at the early gestation is often questioned regarding their impact on offspring. therefore, the aim of this study is to investigate whether miscarriage preventing herbal medicines associated with increased risk of birth defects. a large medication use cohort will be developed by linking a population-based pregnancy registry (i.e., represent) and a population-based pharmacy database, which documented all prescriptions at both outpatients and inpatients from conception to delivery. this cohort will include herbal medicines formula which were granted approval by the chinese national medical products administration. using data from this cohort, the investigators will investigate the prevalence of the use of herbal medicine formulas and prescription patterns at the first trimester. this study will then investigate the association between miscarriage preventing herbal medicines and the risk of birth defects. a propensity score matching (psm) based poisson regression will be used to estimate the relative risk. to ensure the robustness of the results investigators will perform several sensitivity analyses and negative control analyses, such as restricting the population to women with singleton pregnancies, excluding individuals who had undergone in vitro fertilization (ivf), and considering those women who were prescribed herbal medicines during the middle and late stages of pregnancy as the negative exposure control group.

Eligibility criteria:
inclusion criteria: * pregnancies registered at represent and underwent live births between january 2013 and december 2018 were included. exclusion criteria: * (1) those with the first antenatal visit occurring after 20 gestational weeks, (2) those without timing records of the last menstrual period or delivery dates, (3) those with known factors related to birth defects (e.g.,syphilis positive, epilepsy), (4) those prescribed known medications associated with birth defects (e.g.,dezocine, diazepam).

Keywords: herbal medicines birth defects drug exposures cohort study
behavioral activation plus savoring for university students

Conditions: Mood; Anhedonia; Depression

Summary: the current investigation aims to examine whether a brief, two-session, virtual behavioral activation plus savoring intervention will increase daily positive emotion in university students.

experiences of positive emotions are often unchanged following standard psychotherapy. to address this, the current investigation aims to enhance traditional brief behavioral activation with savoring, an emotion regulation strategy specifically targeting positive emotion, or affect, for university students endorsing low levels of the symptom. individuals will be randomized to either a two-session behavioral activation plus savoring intervention or two sessions of empathic listening. daily levels of positive emotions will be assessed throughout the study and for one week prior to and completing the intervention.

Eligibility criteria:
inclusion criteria: * university student * own a smartphone * positive affect score less than 32 on the positive and negative affect schedule, short form (panas-sf)
persistence of antibodies at 3, 4 and 6 years of age after vaccination with meningococcal, pneumococcal and hib vaccines

Conditions: Neisseria Meningitidis; Haemophilus Influenzae Type b

Summary: this protocol posting deals with objectives \& outcome measures of an extension phase when subjects are aged 3, 4 and 6 years of age. the objectives \& outcome measures of the primary phase are presented in a separate protocol posting (nct number = nct00334334). the objectives \& outcome measures of the booster phase are presented in a separate protocol posting (nct number = nct00463437). the purpose of this study is to evaluate the persistence of pneumococcal, meningococcal serogroup c, hib and hepatits b antibodies after booster vaccination, when the subjects are aged 3, 4 and 6 years. no vaccine will be administered during this persistence phase of the study.

this multicenter study is open. no vaccine will be administered during this persistence phase of the study. the subjects were randomized in the primary vaccination study 107005 and will not be further randomized in this study.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female between, and including, 36 and 40 months of age at the time of visit 1; between, and including, 48 and 52 months of age at the time of visit 2; and between, and including, 72 and 76 months of age at the time of visit 3. * written informed consent obtained from the parent or guardian of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * subjects who previously participated in the primary and booster studies, who received a full vaccination course with the vaccines corresponding to their group during the primary and booster studies and who were part, in the booster study, of the blood sampling subset. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first blood sampling. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * administration of any additional meningococcal serogroup c, hib, hepatitis b and pneumococcal vaccine since the end of the booster study * history of meningococcal serogroup c, haemophilus influenzae type b, hepatitis b and invasive pneumococcal diseases since the end of booster study. * any confirmed or suspected immunosuppressive or immunodeficient condition since the end of booster study, based on medical history and physical examination (no laboratory testing required). * administration of immunoglobulins and/or any blood products within the three months preceding the first blood sampling.

Keywords: conjugate vaccines meningococcal serogroup c vaccine antibody persistence pneumococcal vaccine haemophilus influenzae type b vaccine
an observational study on roactemra/actemra (tocilizumab) in clinical practice in patients with rheumatoid arthritis (trust)

Conditions: Rheumatoid Arthritis

Summary: this observational study will evaluate the efficacy and safety of roactemra/actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis. data will be collected from patients for the 12 months following the first infusion of roactemra/actemra.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * rheumatoid arthritis diagnosed according to american college of rheumatology (acr) criteria * initiated on roactemra/actemra treatment according to the summary of product characteristics not more than 6 months before opening of study center exclusion criteria: * current serious infection * hypersensitivity to the active component or any of the excipients * pregnant women
escalation of doses of daratumumab in combination with chemotherapy (idarubicin and cytarabine) in patients of 60 years old or more with adverse risk acute myeloblastic leukemia (aml) (daralam)

Conditions: Adult Patients With Adverse Risk Acute Myeloblastic Leukemia

Summary: to search for a maximum tolerated dose (mtd) for the combination of daratumumab and induction chemotherapy with idarubicin and cytarabine in patients with acute myeloblastic leukemia (aml) of poor prognosis


Eligibility criteria:
inclusion criteria: * age \>= 60 ans * poor prognosis aml defined according to the following criteria:1. for first-line aml:intermediate or unfavorable risk according to eln 2022 2.for relapsed aml:regardless of the eln risk group * ecog \<= 2 * patient eligible for intensive chemotherapy * who provide their written informed consent * liver workup: transaminases \< 3x normal, bilirubin \< 1.5 x normal * creatinine clearance \> 60ml/mn * lvef \>= 50%. exclusion criteria: * patients with flt3 itd or tkd mutation * patients with tuberculosis * patients with documented active infection with covid 19 * patients with hereditary fructose intolerance (hfi) * uncontrolled infection * active or past infection with hep b, c or hiv+ * not affiliated with french social security system or no beneficiary from such system * pregnant women or patients who cannot take contraception ( contraceptive pill, abstinence, unauthorised iud) in case of fertility. a patient who cannot continue contraception for at least 6 months after the last injection of daratumumab is not eligible for inclusion. * breastfeeding women * minors * adults under guardianship, curatorship or safeguard of justice * hypersensitivity to any of the active ingredients or excipients * patients with significant cardiovascular pathology including any of the following: myocardial infarction within 6 months prior to study entry, unstabilized coronary artery disease, uncontrolled hypertension, congestive heart failure. * patient with disease requiring systemic immunosuppressive therapy (such as high-dose steroids defined as ≥ 10mg prednisone or equivalent per day) within 4 weeks prior to the 1st scheduled dose of study treatment with the exception of dermocorticoids
long-term follow-up of patients with spinal muscular atrophy treated with oav101 in clinical trials

Conditions: Spinal Muscular Atrophy (SMA)

Summary: this is a global, prospective, multi-center study that is designed to assess the long-term safety and efficacy of oav101 in patients who participated in an oav101 clinical trial. the assessments of safety and efficacy in study coav101a12308 will continue for 5 years after enrollment in this study.

the study is comprised of a baseline visit and 2 follow-up periods. for follow-up periods 1 and 2, which includes baseline through year 5 visits, assessments will be performed at the investigational site. for the first 2 years (follow-up period 1), visits will occur every 6 months. for years 3 to 5 (follow-up period 2) follow-up visits will be conducted annually. all patients will enter the study at the baseline visit and continue for 5 years.

Eligibility criteria:
inclusion criteria: 1. participated in an oav101 clinical trial. 2. written informed consent must be obtained before any assessment is performed. 3. patient/parent/legal guardian willing and able to comply with study procedures. exclusion criteria: there are no exclusion criteria for this study.

Keywords: zolgensma oav101 avxs 101 gene therapy muscle atrophy sbma spinal and bulbar muscular atrophy spinal muscular atrophy bulbar muscular atrophy muscle function myopathy muscle wasting atrophied muscle loss of muscle strength spinal muscular atrophy (sma) survival motor neuron 1 gene (smn1) smn protein depletion survival motor neuron 2 gene (smn2) chromosome 5q13 neurogenetic disorder onasemnogene abeparvovec
compliance with gluten-free diet and affecting factors in adolescents with celiac disease

Conditions: Celiac Disease in Adolescents; Gluten-Free Diet in the Covid-19 Process

Summary: celiac is a chronic autoimmune disease that is treated with a gluten-free diet. adolescents with celiac disease were affected differently by the restrictions during the covid-19 pandemic. the aim of this study was to determine the compliance with a gluten-free diet during in adolescents with celiac disease during the covid-19 pandemic and identify the associated factors. the sample of this study consisted of 85 adolescents in the 10-19 age group diagnosed with celiac disease. research data were collected by online questionnaires (google forms) between january and april 2022. sociodemographic and disease-related data of adolescents who were compliant and those who were non-compliant with a gluten-free diet during the covid-19 pandemic were compared.


Eligibility criteria:
inclusion criteria: * being in the 10-19 age group, * being diagnosed with celiac disease according to the revised espghan criteria, * following a gluten-free diet for at least 6 months before the covid-19 lockdown, * consenting to participate in the study by the adolescents and their parents. exclusion criteria: -having any cognitive or mental disorders.

Keywords: adolescence celiac disease gluten free diet
quantitative fluorescence molecular imaging of ustekinumab-800cw to elucidate the drug distribution throughout inflamed tissue in crohn's disease and psoriasis.

Conditions: Psoriasis; Crohn Disease

Summary: crohn's disease (cd) and psoriasis are chronic inflammatory diseases. ustekinumab is a humanized monoclonal antibody. ustekinumab is expensive and primary non-response is high in both cd and psoriasis. currently, there are no predictors of response to ustekinumab and the actual mechanism of action has not yet been elucidated. to clarify the mechanism of action and gain a better understanding of the high primary non-response rates, the university medical center groningen (umcg) developed a tracer fluorescently labeling ustekinumab. this study aims to gain insight into ustekinumab distribution and concentrations in the gut. the current study aims to identify the ustekinumab target cells in the inflamed gut mucosa and skin using quantitative fluorescence molecular endoscopy (qfme). by gaining insight into local ustekinumab concentrations, drug distribution, and by discovering target cells, we expect to gain insight into the mechanism of action of ustekinumab.


Eligibility criteria:
inclusion criteria: * established diagnosis of cd or pso * non-responsive to conventional therapy * active disease: * cd cohort: clinically active disease of the bowel defined either clinically as at least moderate activity using dedicated scoring indices (for definitions of disease activity, see below) or biochemically active disease as defined by a faecal calprotectin \> 200 ug/g; * pso: clinically active disease of at least pasi ≥ 10 or clinically active disease as assessed by a dermatologist; * age ≥ 18 years; * written informed consent. exclusion criteria: * medical or psychiatric conditions that compromise the patient's ability to give informed consent according to treating medical physician; * prior ustekinumab treatment within the last 15 weeks (except for patients in the treatment arm and control group); * ustekinumab contraindicated as therapy; * pregnancy or breast feeding. a negative pregnancy test must be available for women of childbearing potential (i.e. premenopausal women with intact reproductive organs and women less than two years after menopause);
impact of perioperative exenatide infusion on quality of life in cardiac surgery patients

Conditions: Quality of Life

Summary: a diminution of quality of life is often reported by patients after coronary artery bypass graft (cabg) surgery. a part of this diminution could be explain by postoperative left ventricular (lv) dysfunction. exenatide (byetta®) is an incretin mimetic, characterized by an anti-hyperglycemic effect that depends on the blood glucose level. recent data have suggested that exenatide could improve lv function by an inotropic effect in patients suffering from cardiogenic shock or from congestive heart failure. moreover, patients suffering from congestive heart failure reported a better quality of life when they were treated with exenatide compared to placebo. the investigators hypothesize that perioperative exenatide infusion could improve postoperative quality of life in cabg surgery patients.

the exeqol study is an ancillary study of the exstress trial (www.clinicaltrials.gov identifier: nct01969149). the exstress trial is a phase ii/iii randomized-controlled trial that aim at assessing intravenous exenatide versus insulin for perioperative glycemic control in cabg surgery. the phase ii of the exstress trial will assess the safety and the efficacy of a continuous intravenous infusion of exenatide for the management of post operative stress hyperglycemia after planned coronary artery graft bypass (cabg) surgery. the aim of the phase iii of the exstress trial is to compare the efficacy of a continuous intravenous infusion of exenatide to the gold standard treatment, i.e the intravenous infusion of short-acting insulin, for the management of post operative stress hyperglycemia after planned cabg surgery.

Eligibility criteria:
inclusion criteria: * age over 18. * patient consent. * non insulin requiring type 2 diabetic patients. * non diabetic patients. * planned coronary artery bypass graft (cabg) surgery. * asa (american society of anesthesiologists) score 1, 2, or 3. exclusion criteria: * pregnancy and breast feeding. * pancreatectomy. * acute pancreatitis. * chronic pancreatitis. * type 1 diabetic patients. * insulin requiring type 2 patients. * hba1c\>8% * ketoacidosis. * hyperosmolar coma. * preoperative blood glucose level above 300 mg/dl \[21\]. * insulin or exenatide contraindication. * history of renal transplantation or currently receiving renal dialysis or creatinine clearance below 60 ml/min. * emergency surgery. * planned non cabg cardiac surgery.

Keywords: quality of life cardiac surgery coronary artery bypass graft surgery incretin mimetic exenatide
a study to assess the nicotine pharmacokinetics, tolerability and safety with a new oral nicotine replacement product in healthy japanese smokers

Conditions: Healthy

Summary: in part 1, the purpose of this study is to elucidate the single-dose pharmacokinetic profiles of 1 spray and 2 consecutive sprays of oromucosal nicotine spray (ons) in comparison with those of nicotine gum and cigarette smoking in healthy japanese smokers. in part 2, the purpose is to evaluate the multiple-dose nicotine pharmacokinetics of ons administered repeated-dose administration in healthy japanese smokers.


Eligibility criteria:
inclusion criteria: * healthy male or female japanese participants between the ages of 20 and 50 years, inclusive. health is defined as the absence of clinically relevant abnormalities identified by a detailed medical history, blood pressure, pulse rate measurements, 12-lead electrocardiogram (ecg) as well as clinical laboratory tests, as judged by the principal investigator or sub investigator. * smoking of at least 15 cigarettes daily during at least one year preceding inclusion * body mass index between 17.5 and 30.0 kilogram per square meter (kg/m\^2) and a total body weight greater than or equal to (\>=) 50.0 kg * evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study * all women of childbearing potential, except for postmenopausal females, must have a negative urine beta-human chorionic gonadotropin (beta-hcg) at screening of part 1 and all planned visits of part 1 and part 2 exclusion criteria: * evidence or history of an acute or chronic medical or psychiatric condition or allergy or laboratory abnormality, or of use of drugs that, in the judgment of the principal investigator or sub investigator, increase the risk associated with study participation or interfere with the interpretability of study results * females: pregnancy, breast-feeding, premenopausal, or perimenopausal state with insufficient contraception * treatment with an investigational drug within 3 months preceding the first dose of study product * participant has donated blood or blood product or had substantial loss of blood more than 200 milliliter (ml) within 1 month before study products administration, or greater than or equal to (\>=) 400 ml within 3 months for males and 4 months for females before study products administration, or participant has donated a total volume of blood in the past one year exceeding 1,200 ml for males and 800 ml for females, or participant has an intention to donate blood or blood products during the study and for at least 3 months for males and 4 months for females for blood, or at least 2 months for both genders for blood products after completion of the study * exclusion criterion for only part 2: participants who is analyzed as cytochrome (cyp)2a6 \*4/\*4 by cyp2a6 genetic polymorphism test at visit 1 of part 1
technetium tc 99m sulfur colloid and blue dye in detecting sentinel lymph nodes in patients with breast cancer

Conditions: Breast Cancer

Summary: rationale: it is not yet known whether injecting technetium tc 99m sulfur colloid and blue dye near the tumor is more effective than injecting them near the nipple in identifying sentinel lymph nodes in patients with stage i or stage ii breast cancer. purpose: randomized diagnostic trial to compare the effectiveness of injecting technetium tc 99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in detecting sentinel lymph nodes in patients who have stage i or stage ii breast cancer.

objectives: * determine the optimal mode of injection (peritumoral vs periareolar) of patent blue v dye and technetium tc 99m sulfur colloid in patients with stage i or ii breast cancer undergoing sentinel lymph node identification. * determine the reduction of morbidity associated with breast cancer surgery, in terms of local control and survival, in patients undergoing sentinel lymph node identification with these drugs. * determine the evolution of disease in patients who have undergone this procedure and do not show histological invasion of the sentinel lymph node. outline: this is a randomized, multicenter study. patients are stratified according to participating center. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive peritumoral injections of patent blue v dye and technetium tc 99m sulfur colloid. * arm ii: patients receive periareolar injections as in arm i. patients in both arms showing histological metastasis of the sentinel lymph node or without identification of the sentinel lymph node undergo standard axillary lymph node dissection. patients are followed for disease evolution. projected accrual: a total of 450 patients (225 per arm) will be accrued for this study within 2-2.5 years.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed invasive breast cancer * t0, t1, or t2 no greater than 3 cm, n0 * amenable to surgery * no inflammatory breast cancer * no ductal cancer in situ or multicentric invasive ductal cancer * no nipple/areola or central breast cancer (at least 2 cm from areola) * no metastatic disease * hormone receptor status: * not specified patient characteristics: age * over 18 sex * not specified menopausal status * not specified performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified other * not pregnant * negative pregnancy test * no known allergy or intolerance to patent blue v dye prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * no prior surgery for cancer other * no prior neoadjuvant treatment for cancer

Keywords: stage i breast cancer stage ii breast cancer