Groß Börnecke, Germany

Electroacupuncture for the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer

This study is a parallel-group, blinded (participants, evaluators, and statisticians), randomized controlled trial exploring the effectiveness of electroacupuncture combined with standard quadruple antiemetic drugs for breast cancer patients undergoing HEC. Both groups will receive Olanzapine, Neurokinin-1 receptor antagonists (NK-1RAs), serotonin receptor antagonists [5HT3RA], and dexamethasone at the start of HEC on Day 1. Electroacupuncture or sham acupuncture will be randomly administered to each group. Participants will document all instances of nausea and vomiting and note the use of rescue antiemetic medications. Blood samples will be collected and analyzed to investigate whether genetic polymorphisms can predict electroacupuncture outcomes in breast cancer patients undergoing HEC. Primary and secondary outcomes as well as adverse events will be assessed.

Prevalence of Hyperemesis Gravidarum

Study design: A repeated population based cross sectional survey. A woman can withdraw from the study early for the following reasons: - the woman's decision, - a major protocol deviation, - and loss to follow-up (a subject lost to follow-up is a participant who did not answer to all the surveys) The study may be stopped temporarily or permanently for the following reasons: - Recruitment too low or nonexistent, - Decision of the sponsor and of the investigator-coordinator. Methods of recruitment : The inclusion of women will take place after one of the 1st trimester ultrasounds. They will have to complete, from their home, an online self-questionnaire including, among other things, the modified-PUQE score assessing the severity of nausea and vomiting during the first trimester of pregnancy. Women who have had an early ultrasound, before 10 weeks of amenorrhea (WA), will be re-interviewed at the start of the 2nd trimester via an online questionnaire. Subsequently, women who responded in the 1st trimester and who present with hyperemesis gravidarum or uncomplicated pregnancy-related nausea and/or vomiting will be questioned, again, about the existence of nausea and vomiting just after the deadline for the 2nd trimester ultrasounds (between 20 WA+0 day and 25 WA+0 day) and 3rd trimester (between 30 WA+0 day and 35 WA+0 day), via an online self-questionnaire.

Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer

This study is a randomized controlled trial conducted in parallel groups, with blinding implemented. It aims to assess the effectiveness of combining electroacupuncture with standard quadruple antiemetic drugs for patients with breast cancer undergoing HEC. Both study arms will be administered Olanzapine, Neurokinin-1 receptor antagonists, serotonin receptor antagonists, and dexamethasone at the commencement of HEC on Day 1. Subsequently, participants will be randomly assigned to receive either electroacupuncture or sham acupuncture. Participants will be responsible for recording all instances of nausea and vomiting, as well as documenting the use of rescue antiemetic medications. The study will evaluate primary and secondary outcomes, as well as monitor adverse events.

Etiology of Travelers' Diarrhea in Australian Tourists Traveling to Southeast Asia

Antiemetic Fosaprepitant To Remedy Nausea and Vomiting

Nausea and vomiting (NV) are common and interrelated conditions. Approximately 50% of adults experience nausea in a given year while 30% of adults experience vomiting over the same period. Of this population of symptomatic individuals with NV, 25% of patients seek care in any healthcare delivery setting. Health Care Utilization Project (HCUP) data indicates that nearly 9.0 million patients seek care for NV in emergency departments (EDs) each year in the United States. Antiemetics are used to treat NV. Antiemetics currently utilized in the emergency department setting for NV do not always work on the first dose and have a plethora of side effects because of their peripheral mechanism of action outside of the vomiting reflex pathway in the central nervous system. These medications include ondansetron, promethazine, metoclopramide, olanzapine, haloperidol. Chief among these side effects is alteration of an aspect cardiac electrical signaling called the QT segment which represents the duration of ventricular contraction and relaxation. The QT segment is prolonged with commonly used antiemetics which can often be a prelude to cardiac dysrhythmias that are associated with mortality. As a result, patients with NV often have long length-of-stay (LOS) involving supportive care with intravenous fluids or empiric treatment with medications that can potentiate development of cardiac dysrhythmias. This is a problem in busy emergency departments (EDs) struggling to accelerate patient throughput in order to appropriately keep up with patient volume in an under-supplied hospital bed environment nationally. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in EDs. Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time.

the Efficacy and Safety of Ondansetron Oral Soluble Pellicles

The aim of this study is to observe the efficacy and safety of ondansetron in delayed nausea and vomiting by its continuous dosing, and it is planned to enroll 184 first-time recipients of highly emetogenic single-day chemotherapy regimens (cisplatin dose 60-75 mg/m2; anthracycline compounds adriamycin ≥ 60 mg/m2 or epothilone ≥ 90 mg/m2 ) who were initiated on a triple combination regimen of fosaprepitant + ondansetron orally soluble film + dexamethasone triple regimen for nausea and vomiting prophylaxis in patients. The primary observation was the incidence and severity of delayed nausea and vomiting in both groups from day 5 after chemotherapy to the second cycle of chemotherapy. The secondary observation indexes include the incidence and severity of delayed nausea in patients in both groups from day 5 after chemotherapy to before the second cycle of chemotherapy; the incidence and severity of anticipatory nausea/vomiting in the second cycle of chemotherapy in both groups; the incidence and severity of nausea/vomiting in patients in both groups on days 1-4 after chemotherapy; and the incidence of adverse events and serious adverse reactions, with a focus on the antiemetic drugs common constipation, headache and other events. This trial was randomized into groups, and the experimental group was preset as group A and the control group as group B. The prevention of nausea and vomiting was carried out with the triple regimen of fosaprepitant (Tanneng, Jiangsu Hausen Pharmaceutical Group Co., Ltd.) + Ondansetron Oral Soluble Pellicles (Aiqisu, Jiangsu Hengrui Pharmaceutical Co., Ltd.) + dexamethasone prior to chemotherapy, and the patients were divided into the treatment group A and the control group B by the use of Ondansetron Oral Soluble Pellicles for continuation of the prophylaxis on the 5-7 days after the chemotherapy.

A Study to Learn How Well Dupilumab Works in Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis and the Side Effects it May Have

This study has 2 parts and a 12-week (about 3 months) Follow-up Period for all participants - Part A is an open-label treatment period lasting up to 24 weeks (up to 6 months). "Open-label" means that you and the study doctors and the staff staff will know that you are taking the study drug - Part C is an open-label extended treatment period lasting up to 28 weeks (about 7 months). "Extended Treatment Period" means that you will take the study drug for 28 weeks if you are eligible to take part in this part of the study

Associations of Fecal Bile Acid Profile and Intestinal Flora With Chronic Radiation Enteritis

The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E

Prior to study initiation, study clinics and offices will be set up in each of the enrollment sites. Awareness about the study will be created in the community. All categories of staff will be recruited and trained. CRFs, SOPs and registers will be developed. Regulatory and IRB approvals will be obtained. Permissions and clearances will be sought from the Government. The study team will identify pregnant women, newborns and infants aged less than 8 weeks as potential participants. Information about the study will be shared with these families, and those willing to participate will be enrolled after obtaining consent and subsequent screening of the subject. Subjects will be enrolled in the study since 2 months + 29 days of age and will be given 3 doses of the Test Article/placebo along with childhood vaccines (which will include vaccines against diphtheria, pertussis, tetanus, Haemophilus influenzae B, Hepatitis B and IPV, and pneumococcal conjugated vaccine at 2 and 4 month of age). Participants vaccinated with a dose of vaccine from the National Immunization Program corresponding to their current age, in which more than 48 hours have passed since the last dose received, the subject will not be considered for the study. The Test Article will be liquid ORV 116E, 105.0ffu stored at 2-8°C. The Test Article/placebo will be co-administered with the childhood vaccines that are scheduled at the regular National Program of Immunization vaccination visits around 2 months, 4 months and 6 months of age. After each visit, a safety evaluation will be carried out on all participants. A card will be given to the caregivers for the daily record of temperature, diarrhea, vomiting, food refusal and/or irritability, for a period of 1 week. On day 3 and 7, the research team will contact the caregivers by telephone to note the general state of health of the infant and to collect the card. The subjects will be followed f or episodes of acute gastroenteritis every two weeks through contact by email or text message (+ 2 days), until 8 months + up to 14 days post 3 doses of vaccination. The expected duration of subjec participation is 13 months. In addition to the contacts at every two weeks follow-up, parents/primary caregiver will be advised to contact the study team whenever the subject has symptoms of gastroenteritis (GE; the operational definition of GE for this study will be the change in the habitual pattern of the stools, both in more frequent passage than is normal for the individual and/or in the decrease in stool consistency), signs or symptoms of suspected intussusception (IS, defined as stomach pain and vomiting that start suddenly and come and go several times per hour, and then later, bloody stools) or any other illness requiring hospital referral. If the caregiver report symptoms of GE, an "illness visit" will be activated. The caregiver will be asked to collect a stool specimen. The field worker will ensure that the parents/primary caregiver have stool containers available with them so that stool specimens can be collected whenever the enrolled subject has GE. In the next 24-48 hours, the stool sample will be processed with an ELISA rotavirus test. If the result is negative, the illness visit will be discontinued, and the episode will be registered. If the result is positive, a daily telephone follow-up will be carried out throughout the GE episode, up to 24 hours after the last altered stool. If during the illness visit any symptom/sign of dehydration and/or clinical severity is verified by the research team, the participant will be invited to be evaluated at the study center. During the illness visit the following variables will be collected daily by the caregiver in an illness visit card: stools number and consistency, vomiting episodes, temperature (based on subjective perception of the caregiver of potential fever, or at the same time point during the consecutive days, preferably between 2 and 8 PM), administration of ORS yes/no, number of administrations, and if possible, volume administered). If the child is hospitalized, the following information will be obtained from hospitalization charts: number and consistency of stool episodes, number of vomiting episodes, highest daily temperature, hydration evaluation, use of ORS and/or IV solutions (volume used and fluid description) duration of hospitalization, and any potential complication. If in the follow-up every two weeks of the participants, an episode that did not activate the illness visit of GE is reported or detected, the episode will be recorded and an attemp t will be made to collect as much data as possible retrospectively. The study team will contact the parents/primary caregiver through mobile phone and collect the information of the illness visit card. Out of the enrolled subjects, 150 from each group will constitute the "Immunogenicity Subset". Visit 1 Baseline (vaccine at 2 Months of age + 29 days): - The participant will be screened for eligibility based on vitals (heart rate and body temperature) and physical examination. - If the participant is eligible (in good general health or stable preexisting disease as per the discretion of the Principal investigator). - A study vaccine/placebo will be administered. Following vaccination, participants will remain at the study site for at least 30minutes of observation to record any immediate adverse event. - Daily card will be given to the parent/primary caregiver. - Blood sample (3 mL) will be collected for immunogenicity analysis in a subset of (n=300) participants prior to vaccination. Visit 2 (vaccine at 4 Months of age, +29 days): - Study participants will return to the OPD for vitals and physical examination (general and systemic examination). A study vaccine /placebo will be administered. - Following vaccination, participants will remain at the study site for at least 30minutes of observation to record any adverse event. - Daily card will be collected and a new card will be given to the parent/primary caregiver. Visit 3 (vaccine at approximately 6 Months of age, +29 days): - Study participants will return to the OPD for vitals and physical examination (general and systemic examination). A study vaccine /placebo will be administered. - Following vaccination, participants will remain at the study site for at least 30minutes of observation to record any adverse event. - Diary card will be collected and a new card will be given to the parent/primary caregiver. Visit 4 (1 Month after visit 3 ++5days): (only for immunogenicity group) - Study participants (Subset) will return to the OPD for physical examination (general and systemic examination) and diary card will be collected. - Blood sample (3 mL) will be collected for immunogenicity analysis in a subset of n=300. - Diary card (Photograph) will be collected from the non-immunogenic participants. Blood samples: In the "Immunogenicity Subset", 3 ml blood specimens will be collected at baseline and 28 (+) 5 days after the third dose of the Test Article/placebo to assess the anti-rotavirus IgA antibody titer. Stool Specimens: The study team will attempt to collect a stool specimen for every GE episode, preferably within the first 2 days after episode onset . The stool specimen may be collected up to 7 days after the last day of diarrhea. The stool specimens will be sent to the laboratory. If the episode is a suspected intussusception or vaccine associated gastroenteritis that has occurred within four weeks after each dose of the Test Article/placebo, the specimen will be sent to the laboratory immediately for rotavirus testing and typing. For all ELISA RV positive samples, an aliquot of the stool specimen will be assessed for 22 enteropathogens by multiplex-PCR panel and to identify the genotype of the virus.

InvaplexAR-Detox and DmLT Adjuvant in the Netherlands and Zambia

Rationale: Shigella remains endemic in many places and occurs in epidemics that cause considerable morbidity and mortality. Vaccines are an attractive and potentially highly cost-effective tool for the prevention of shigellosis and can fill current gaps in effective prevention strategies. A challenge to effective Shigella vaccine development has been the reduced immunogenicity and protective efficacy of candidate Shigella vaccines in infants and children less than 3 years of age. The potential impact of including an adjuvant in candidate parenteral Shigella vaccine formulations needs to be evaluated. InvaplexAR-Detox is an injectable Shigella vaccine that uses a novel combination of conserved invasion plasmid antigen proteins with a serotype-specific bacterial lipopolysaccharide attenuated for safe intramuscular administration. The adjuvant dmLT has been shown to significantly enhance Shigella immune responses in mice and has safely been administered intramuscularly in healthy volunteers in combination with other antigens in phase I trials. Objective: to evaluate the safety and immunogenicity of two strength formulations of a candidate Shigella vaccine (2.5 or 10 μg Sfl2a InvaplexAR-Detox) given with and without adjuvant (0.1 μg dmLT). Study design: this is a phase Ia/b dose escalation, randomized, double-blind, placebo-controlled trial assessing the safety, tolerability and immunogenicity of three vaccinations given 4 weeks apart of Sfl2a InvaplexAR-Detox vaccine alone or in combination with the dmLT adjuvant in the Leiden University Medical Center in the Netherlands and at the Centre for Infectious Disease Research in Zambia (CIDRZ). The study will be initiated with the low vaccine dose in the Netherlands (Cohort A) and will not proceed to the high vaccine dose in the Netherlands (Cohort B) before the safety data of Cohort A has been reviewed by the Safety Monitoring Committe (SMC). The SMC will also review the safety data of Cohort B before the high vaccine dose will be administered in Zambian adults (Cohort C). Study population: a total of 50 healthy Dutch and 35 healthy Zambian adults aged 18-50 years. Intervention: a 2.5 μg or 10 μg intramuscular dose of the candidate Shigella vaccine Sfl2a InvaplexAR-Detox given with and without double mutant (LT R192G/L211A) enterotoxigenic Escherichia coli heat labile toxin adjuvant (0.1 μg dmLT) given at day 1, day 29 and day 57 compared to a placebo (saline). Main study endpoints: Primary endpoint measures are the occurrence of solicited and unsolicited adverse events considered to be related to vaccination. Secondary outcome measures are humoral and cellular immune responses to vaccination with and without adjuvant compared to placebo.