Kornimate/medical-research-clean huggingface dataset:
study of the effect of intramuscular ephedrine on the incidence of nausea and vomiting during elective cesarean section

Conditions: Nausea; Vomiting; Cesarean Section

Summary: the purpose of this research study is to investigate if the incidence of nausea and vomiting that subjects experience during and after a cesarean section can be reduced by giving a shot of the drug ephedrine into the thigh muscle at the time of spinal anesthesia administration.

this research project is designed to study the medication ephedrine, when it is given as a routine part of the anesthesia for elective cesarean section. ephedrine is a medication that is widely used in labor and in vaginal and operative (cesarean section) deliveries to help maintain a woman's blood pressure within its normal range, especially after spinal and epidural anesthesia has been administered. the purpose of this study is to determine if ephedrine, when given intramuscularly (\ as a shot in the muscle), at the time of spinal anesthesia administration, can help to decrease the incidence of nausea and vomiting subjects experience during and after a cesarean section. this study will compare women who receive ephedrine to a similar group of women who receive a normal saline placebo. in addition to looking at the difference in the incidence of nausea and vomiting perioperatively, this study will also evaluate if the administration of im ephedrine helps the baby to receive more blood from the placenta after anesthesia has been administered to the mother. this will be evaluated by performing a simple blood test, drawn from the umbilical cord, after the baby is born.

Eligibility criteria:
inclusion criteria: * must be pregnant with a single baby * must be at term in their pregnancy (estimated gestational age of at least 38 weeks) * must be scheduled for an elective cesarean section * must be between 60-70" tall * must be free of severe systemic disease (asa class i or ii) exclusion criteria: * contraindication to spinal anesthesia * any allergy to any of the medications included in the study * history of pregnancy-induced hypertension or preeclampsia * history of preexisting hypertension * diabetes mellitus * hyperemesis gravidum * previous perioperative nausea and vomiting * history of motion sickness * women carrying a fetus with a known abnormality will also be excluded from the study

Keywords: nausea vomiting cesarean section
an efficacy, safety and pharmacokinetics study of beloranib (zgn-440 for injectable suspension) in obese subjects

Conditions: Obesity

Summary: the purpose of this study is to evaluate weight reduction, safety and pharmacokinetics for certain doses of beloranib (zgn-440 for injectable suspension) administered as twice-weekly subcutaneous injections for 12 weeks.

this protocol is designed to test the safety and efficacy of a drug called beloranib (zgn-440 for injectable suspension). it is to be tested for its ability to reduce weight in obese subjects. the study will provide information on how much zgn-440 gets into the blood, how long it stays in the body, and how it affects other biological markers.

Eligibility criteria:
inclusion criteria: * obese volunteers weighing ≥ 50 kg * bmi ≥ 30 and ≤ 50 kg/m2 * stable body weight during the past 2 months * type 2 diabetes mellitus is allowed exclusion criteria: * use of weight loss agents in the past month * current, clinically significant eating disorder * type 1 diabetes mellitus

Keywords: obese obesity overweight weight loss weight reduction beloranib
comparison of epidural labor pain relief techniques on maternal and fetal outcomes

Conditions: Laboring Women Requesting Neuraxial Labor Analgesia

Summary: the primary objective of this study is to compare the onset and duration of the initial dose of medications given through three different epidural (conventional epidural, combined spinal epidural and dural puncture epidural) techniques for labor pain relief. the secondary objective of this study is to compare the fetal effects of these three epidural labor analgesia techniques.


Eligibility criteria:
inclusion criteria: * 1. nulliparous (first baby) parturient 2. singleton, vertex gestation at term (37-42 weeks) 3. less than 5 cm dilation 4. desires an epidural technique for labor analgesia exclusion criteria: - 1. current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes) 2. any contraindication to the administration of an epidural technique 3. history of hypersensitivity or idiosyncratic reaction to local anesthetic or opioid medications 4. current or historical evidence of a disease which may result in the risk of a cesarean delivery. 5. evidence of anticipated fetal anomalies

Keywords: neuraxial technique epidural technique dural puncture epidural technique combined spinal epidural technique labor analgesia obstetric
cognitive function in patients with persisted atrial fibrillation

Conditions: Atrial Fibrillation, Persistent; Cognitive Function

Summary: compare the difference of cognitive function between different treatment strategy in patients with persistent atrial fibrillation

the prevalence of atrial fibrillation (af) had been increasing for the past decade. the increase of af was attributed to the aging of the population and the increased awareness of the disease among people and the primary physicians. however, we have not achieved the consensus whether aggressive rhythm control or conservative rate control is better in a patient with asymptomatic persisted af. we do prescribe anti-coagulant for stroke prevention, but which treatment strategy is best for the patients is uncertain. the clinical trial of catheter-based ablation for rhythm control compared to traditional medication control has not shown the benefit of reducing all-cause mortality, but it did show a reduction of re-hospitalization and the recurrence of af. on the contrary, the study in heart failure patients had shown a significant benefit applying catheter-based rhythm control strategy to reduce all-cause mortality. the different results of these two trials told us the benefit of rhythm control is not easily to be seen in a short-term, but could be seen in a long term or in high risk patients. the association between af and cognitive impairment has also been reported in observation cohort. however, there is no sold evidence in clinical trials to show the improvement of cognitive function by treating atrial fibrillation. one study did show improvement of cognitive function with questionnaire, but the other showed new lesion detected by traditional magnetic resonance imaging (mri) after ablation, though the lesion resolved after one year of follow-up. there is no clear answer to which treatment strategy is better for the patients' cognitive function。 therefore, we designe a prospective, randomized, blind endpointtrial. we will enroll the patients with persisted af, and use advanced mri (dti/swi) and questionnaire to longitudinally study the cognitive function change of the patients before and after the initiation of anti-coagulant agents, before and after the catheter-based ablation, and use this as a surrogate to understand the best treatment strategy for these af patients.

Eligibility criteria:
inclusion criteria: 1. those who meet the diagnosis of persistent atrial fibrillation, meet one of the following conditions: * the twelve-lead electrocardiogram is used to diagnose atrial fibrillation, and to cooperate with clinical diagnosis. * 24 hours ecg diagnosis 100% atrial fibrillation, with clinical diagnosis. * the seven-day ecg recorder diagnosed 100% atrial fibrillation. 2. willing to accept treatment recommended by doctors, containing anticoagulant, and cooperate with examination and treatment in the coming year. exclusion criteria: 1. unwilling to sign the clinical trial consent form. 2. unable to complete the cognitive function questionnaire. 3. unable to complete brain mri examination due to various reasons

Keywords: atrial fibrillation cognitive function
evaluation of lung atelectasis during apneic oxygenation using thrive in adults during laryngeal surgery.

Conditions: Anesthesia

Summary: oxygenation with high-flow nasal cannula with 100% oxygen have now been evaluated in a number of studies and the data are convincing. the thrive technique is able to oxygenate patients safely and vital parameters has been shown to be stable. but it is of great importance to evaluate this new concept regarding other potential negative physiological aspects such as lung atelectasis and inflammatory stress response before implementing it into clinical practice.


Eligibility criteria:
inclusion criteria: 1. adults, \>18 years old. 2. ent-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery). 3. capable of understanding the study information and sign the written consent. exclusion criteria: 1. asa\>2 2. nyha \>2 3. pacemaker or icd. 4. bmi \>35 5. pregnancy 6. manifest cardiac failure or coronary disease 7. severe gastrointestinal reflux. 8. neuromuscular disorder
isoelectric focusing of tears in children with radiologically isolated or clinically isolated syndrome

Conditions: Clinically Isolated Syndrome; Radiologically Isolated Syndrome; Multiple Sclerosis in Children

Summary: the main gold of this study is to lead a multicentric, prospective study, to evaluate the diagnostic quality of tears in children with clinically isolated syndrome (cis) and radiologically isolated syndrome (ris) during a longitudinal follow-up.

multiple sclerosis (ms) is a disease that affects the white matter of the central nervous system. in france, approximately 100,000 patients are affected. it is one of the most common neurological condition in young adults. the presence of supernumerary oligoclonal bands (ocbs) in the cerebrospinal fluid (csf) in comparison to the serum was established in 2017 as a criterion for temporal dissemination in ms patients. this is a predictive factor of conversion to ms in the clinically isolated syndrome (cis) and radiologically isolated syndrome (ris), either in children or adults. however, the main inconvenient of ocb analysis in csf is the requirement of a lumbar puncture, which is a traumatising technique that may raise ethical concerns especially when it has to be performed in children. searching for ocbs in tears, which are more accessible, may represent an attractive alternative. some published articles studying adult populations go in this direction, but there are no data in the literature regarding children. the main gold of this study is to lead a multicentric, prospective study, to evaluate the diagnostic quality of tears in children with clinically isolated syndrome (cis) and radiologically isolated syndrome (ris) during a longitudinal follow-up.

Eligibility criteria:
inclusion criteria: * age \< 18 years old * informed consent from the child and the parents (at least one of the two legal guardians) * child covered by social security for the ris population: * asymptomatic child * fortuitous discovery of lesions strongly suggesting sclerosis multiple on a magnetic resonance imaging (mri) scan for the cis population: - child presenting a cis in the past three months exclusion criteria: * patient with remitting ms * patient with progressive ms * patient with eye infection * patient under immunosuppressive therapy on the day of inclusion due to the treatment of another disease than ms

Keywords: clinically isolated syndrome radiologically isolated syndrome multiple sclerosis children tear analysis
the interaction between diabetes and estradiol on human brain metabolism in postmenopausal women

Conditions: Diabetes Type 2; Dementia

Summary: the primary aim of this study is to test whether type 2 diabetes interacts with estradiol on brain metabolism in vivo in humans. this will be accomplished by imaging brain metabolism using positron emission tomography before and after short-term administration of transdermal 17β-estradiol in 10 postmenopausal women with diabetes and 10 non-diabetic postmenopausal women.

epidemiological studies suggest there may be an interaction between type 2 diabetes and estrogen in postmenopausal women, such that diabetes may interact with estrogen levels over time to increase risk for dementia. the mechanism for this effect is now known. however, animal research suggests that it may occur through estrogen's effects on cellular metabolism of glucose and ketone bodies. the primary aim of this study is to test whether type 2 diabetes interacts with estradiol on brain metabolism in vivo in humans. this will be accomplished by imaging brain metabolism using positron emission tomography before and after short-term administration of transdermal 17β-estradiol in 10 postmenopausal women with diabetes and 10 non-diabetic postmenopausal women.

Eligibility criteria:
inclusion criteria: 1. willing to provide written informed consent 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. female, postmenopausal, aged 60-80 4. normal results on recommended healthcare screenings (e.g., mammogram, pap smear, colonoscopy) 5. bmi 20-35 kg/m2 6. no evidence of dementia or mild cognitive impairment (moca score \>25) 7. able to access reliable transportation to study and intervention visits exclusion criteria: 1. use of hormone replacement therapy within the past 3 months 2. history of renal, heart, liver, or neurological disease; head injury with loss of consciousness in the past 5 years; chronic pain, anxiety or depression 3. presence of medical conditions that might contraindicate estrogen use (e.g., unexplained vaginal bleeding, history of reproductive tissue cancer, thrombosis) 4. currently taking insulin, metformin, or any other drug or medication judged by the study physician to affect safety or research outcomes of interest 5. involved in another research study 6. contraindications for mri or pet scanning 7. current smoker

Keywords: women's health estradiol postmenopausal
a randomized controlled study of postoperative adjuvant therapy of uracil-tegafur (uft) compared with cyclophosphamide/methotrexate/5-fluorouracil (cmf) in breast cancer (nsas-bc)

Conditions: Breast Cancer

Summary: this is a randomized controlled study designed to evaluate the relapse-free survival of the uft group compared with the cmf group. patients will be randomly assigned to receive either cmf or uft within 12 weeks after curative resection. to evaluate treatment efficacy, data on recurrence, and survival will be collected for up to 10 years after enrollment of the final patient. to assess safety, data on adverse events will be collected for 2 years after the start of treatment. patients'quality of life will be assessed by means of a questionnaire.


Eligibility criteria:
inclusion criteria: * age 18 to 75 * performance status 0 or 1 (ecog) * hematopoietic wbc ≥ 4,000/mm\^3 platelet ≥ 100,000/mm\^3 * hepatic ast and alt ≤ 2.5 times upper limit of normal(uln) total bilirubin ≤ uln * renal creatinine ≤ uln exclusion criteria: * prior anticancer treatment

Keywords: breast cancer
retinal blood flow and microthrombi in type 1 diabetes

Conditions: Diabetes; Diabetic Retinopathy

Summary: the project aims to find mechanisms for the abnormal retinal blood flow that in diabetic patients often precedes any evidence of clinical retinopathy and may contribute to the development of retinopathy. specifically, the projects tests the hypothesis that reduced retinal blood flow found in young patients with type 1 diabetes reflects increased resistance in the small vessels of the retina caused by the formation of small blood clots, called microthrombi; and that antiplatelet agents normalize the reduced retinal blood flow.

the ultimate goal of this research is to contribute to the development of strategies to prevent diabetic retinopathy. this project will test the hypothesis that antiplatelet agents normalize the reduced blood flow observed early in the course of type 1 diabetes. if the hypothesis is proven correct, the results will indicate that the formation of small blood clots (microthrombi) occurs early in diabetic retinal vessels. in turn, because microthrombosis could readily account for the occlusive microangiopathy that causes the sight-threatening stages of diabetic retinopathy, the results will propose the desirability of antiplatelet therapy for the prevention of diabetic retinopathy. we have three specific aims: 1. to confirm that, under basal conditions, retinal blood flow measured with the laser doppler method in a group of type 1 diabetic patients with no or minimal retinopathy differs from the flow measured in age- and sex-matched nondiabetic control subjects; 2. to determine whether the response of retinal blood flow to low-dose aspirin (81 mg/day) administered for 2 months versus placebo, differs between type 1 diabetic patients with no or minimal retinopathy and age- and sex-matched nondiabetic control subjects; 3. to determine whether in type 1 diabetic patients with no or minimal retinopathy the response of retinal blood flow to low-dose aspirin differs from the response to clopidogrel, a drug that interferes with platelet function downstream of the site of aspirin action.

Eligibility criteria:
inclusion criteria: * age 18-45 years, * type 1 diabetes duration 1-15 years, * absent or minimal retinopathy (edtrs 20). * age- and gender-matched healthy controls exclusion criteria: * smoking, * systemic diseases other than diabetes, * retinal diseases other than diabetic retinopathy, * pregnancy, * bleeding disorders, * aspirin allergy, * use of anti-platelet agents, * non-steroidal anti-inflammatory agents, * angiotensin converting enzyme inhibitors, * angiotensin receptor antagonists, * vitamin e in large doses.

Keywords: retinal blood flow diabetic retinopathy microthrombosis aspirin clopidogrel
effectiveness of a mindfulness based diet program on weight loss

Conditions: Obesity; Weight Loss

Summary: meditation interventions, including mindfulness-based approaches, can be effective in reducing psychological stress . mindfulness meditation, which cultivates awareness of present-moment experience with a nonjudging attitude, is theorized to promote adaptive self-regulation,which is thought to be key to maintaining long-term eating habits and appetite regulation.in the light of this information, in this study, it is aimed to observe the effect of mindfulness approach on body weight and eating behaviours.

the use of minfulness based programs for body weight control and stress management is increasing. one of the main reasons for this situation is that individuals care more about the diet and body weidght as a result of the increase in health concerns and stress. in addition, such cognitive support programs in the diet process provide a more comfortable and stress-free continuation of the diet. based on the above-mentioned information; in this study, it is aimed to determine the effect of mindfulness based diet intervention on weight loss and eating behaviuors. individuals who meet the research criteria will randomize according to their file numbers (with the ramdomizer program) and divide into 2 groups: mindfulness group (15) and control group . food consumption records, anthropometric measurements and eating behaviours scale of all individuals will record at the beginning and end of the study. in order to prevent interaction between individuals, all diet programs will prepare at different times and individually.

Eligibility criteria:
inclusion criteria: * being between the ages of 20-65 * being obese (bmi≥30 kg/m2) * volunteering to participate in research exclusion criteria: * being pregnant/lactating * having a psychological problem * being on a followed diet program

Keywords: obesity weight loss mindfulness
to assess the effectiveness and safety of zepzelca in adult patients with extensive stage small cell lung cancer (sclc)

Conditions: Extensive-stage Small-cell Lung Cancer

Summary: to assess the effectiveness and safety of zepzelca in adult participants with extensive stage small cell lung cancer (sclc) in real-world clinical practice.

a phase iv, prospective, single arm, multi-center, observational study to collect safety and outcome data of zepzelca in adult participants with extensive stage sclc previously exposed to at least one line of treatment with platinum-based chemotherapy. patients enrolled in the study will be encouraged to complete patient reported outcome (pro) questionnaires.

Eligibility criteria:
inclusion criteria: 1. patient has initiated or will be receiving zepzelca treatment in line with the local zepzelca prescribing information. 2. decision to initiate treatment with zepzelca was made as per investigator's routine treatment practice prior to enrollment in the study. 3. patient, or a legally acceptable representative, signed the informed consent before any study-related activities are undertaken. 4. patients initiating zepzelca treatment in second-line. 5. patients who are sensitive to platinum-based chemotherapy with ctfi≥180 days. the ctfi is defined as the length of time from last platinum dose to time of relapse or disease progression. 6. eastern cooperative oncology group performance status (ecog) ≤1 exclusion criteria: 1. patients who discontinued a prior zepzelca treatment due to adverse events. 2. patient who received more than 2 cycles of zepzelca treatment in their current treatment schedule. 3. patient received treatment with any investigational agent within 30 days prior to first zepzelca infusion or plans to use another investigational agent while receiving zepzelca. 4. known cns involvement prior to zepzelca treatment. 5. patients who were treated with zepzelca in later lines rather than in second-line treatment