Treatment Trials

346 Clinical Trials for Various Conditions

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RECRUITING
Olanzapine 2.5 vs 5 mg in Quadruplet Nausea/Vomiting Prophylaxis Before High-Dose Melphalan
Description

Patients who receive a chemotherapy called melphalan are at high risk of having nausea and vomiting. A medication called olanzapine has been shown to decrease nausea and vomiting after chemotherapy. A previous research study found the 10 mg dose of olanzapine (combined with 3 standard medications used routinely to prevent nausea/vomiting) to be effective for patients who received melphalan chemotherapy, but several other studies have shown many patients have a side effect of sleepiness (e.g., sedation) with that dose of the medication. Our study will compare two lower doses of olanzapine (5 mg and 2.5 mg) in combination with the 3 standard medications used to prevent nausea/vomiting in the patients who receive melphalan chemotherapy to determine which dose is effective in preventing nausea and vomiting with the lowest amount of sleepiness side effect.

WITHDRAWN
Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP)
Description

The primary objective of this proposal is to conduct an early Phase 2 clinical trial to determine the acceptability, dosing, tolerability and safety of mirtazapine for severe nausea and vomiting of pregnancy (sNVP) that is not adequately responsive to current standard treatments. This plan mirrors clinical practice since commonly prescribed antiemetic/ antinauseant drugs will be tested for efficacy before treating with mirtazapine.

COMPLETED
The Effects of IV vs Oral Dexamethasone on Postoperative Nausea, Vomiting, and Pain
Description

The hypothesis being tested in this study is that perioperative oral administration of dexamethasone, when compared to intravenous (IV) administration, offers a similar reduction in postoperative nausea and vomiting (PONV), and reduction in postoperative pain in pediatric patients undergoing tonsillectomy with or without adenoidectomy and/or tympanostomy tube placement. The specific aim of this study is to demonstrate non-inferiority of oral dexamethasone when compared to IV dexamethasone, given that there is currently a severe, sudden, and world-wide shortage of IV dexamethasone given its recent use in treating patients with covid19 disease.

COMPLETED
Olanzapine for Nausea/Vomiting Prophylaxis in Recipients of Hematopoietic Stem Cell Transplants
Description

The purpose of this research study is to see if olanzapine helps to prevent nausea and/or vomiting (throwing up) when it is added to other medicines in subjects having stem cell transplants. Subjects will either be given olanzapine or an inactive pill (called a placebo) before getting any chemotherapy that is known to cause nausea and vomiting. During the study, the study coordinators will ask the subjects to complete surveys to understand if the patient is having nausea and vomiting, and if so, how bad it is making the patient feel. This trial will split subjects into two groups: one group will be given an inactive pill (placebo), and the other group will be given the active pill (olanzapine). Study coordinators will collect surveys every morning before chemotherapy and 5 days after the last dose of chemotherapy. These surveys may be given by members of the study team or possibly on a mobile device. Subjects may benefit from being in this research study because olanzapine may reduce the frequency or severity of chemotherapy-induced nausea and vomiting (CINV). The most common risks of using olanzapine include possibly becoming more tired, mild dizziness, mild low blood pressure, and mild muscle "quivering." Other possible adverse effects include low blood pressure, muscle weakness, increased appetite, weight gain, constipation, and liver function test changes however these risks are less common in subjects with cancer. In addition, there may be a change detected in heart rhythm however subjects will be screened for this ahead of time.

COMPLETED
A Randomized Controlled Trial to Evaluate the Efficacy of Acupuncture Versus Aromatherapy as Treatments to Lessen Nausea, Vomiting and Anxiety Associated With Adriamycin and Cytoxan
Description

The overall goal of this study is to explore the effectiveness of using acupuncture versus aromatherapy, in conjunction with standard of care anti-emetics, to decrease chemotherapy induced nausea, vomiting, and anxiety in breast cancer patients undergoing Adriamycin and Cytoxan. This study also aims to determine if aromatherapy and anti-emetics is more effective than acupuncture and anti-emetics in treating nausea, vomiting, and anxiety in patients receiving Adriamycin and Cytoxan and if acupuncture and anti-emetics is more effective than aromatherapy and anti-emetics in treating nausea, vomiting, and anxiety in patients receiving Adriamycin and Cytoxan.

COMPLETED
The Effect of Scent on Pregnancy Induced Nausea, Vomiting, and Quality of Life
Description

This study evaluates the effects of essential oils on nausea, vomiting, and quality of life scores among pregnant women. Participants will receive either an essential oil roll-on product or a placebo product to apply to their temples and jaw line daily for 6 days.

TERMINATED
Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy
Description

This randomized phase II trial studies how well rolapitant hydrochloride works in preventing nausea/vomiting in patients with sarcoma receiving chemotherapy. Antiemetic drugs, such as rolapitant hydrochloride, may help control or prevent nausea and vomiting in patients treated with chemotherapy.

COMPLETED
Acupuncture and Nausea/Vomiting in Pediatric Patients
Description

The purpose of this study is to investigate the effects of intraoperative P6 acupuncture plus standard therapy on postoperative nausea and vomiting in pediatric patients undergoing tonsillectomy with or without adenoidectomy. 200 children will be randomly assigned to either the treatment or the control group. 1. Treatment Group: Standard anti-emetic therapy plus bilateral P6 acupuncture after the induction of anesthesia 2. Control Group: Standard anti-emetic therapy only This study will monitor nausea, retching, and vomiting events both directly after the surgery as well as the next day via a follow-up phone call to the parents of the study participant.

TERMINATED
Vestibular Dysfunction as a Cause of Chronic Nausea & Vomiting: A Follow up Survey
Description

The purpose of this study is to characterize the accompanying symptoms, evaluation and management of patients with chronic vestibular dysfunction presenting with nausea and vomiting.

COMPLETED
The Effect of Electroacustimulation on Postoperative Nausea, Vomiting and Pain in Outpatient Plastic Surgery Patients
Description

Introduction: Current rates of postoperative nausea and vomiting (PONV) experienced by outpatient surgery patients are as high as 20-30%. Electroacustimulation (EAS) therapy has been demonstrated to be effective in controlling these symptoms, but trials identifying their efficacy in the outpatient surgery population are lacking. This study integrates conventional pharmacotherapy with alternative medicine in prevention of PONV. Materials and Methods: One hundred twenty two patients undergoing surgery procedures at an outpatient surgery center were randomized to two treatment arms. The first arm was standardized pharmacologic PONV prevention typical for patients undergoing outpatient surgery, while the second arm employed the use of ReliefBand, an FDA-approved electroacustimulation (EAS) device with pharmacologic treatment to relieve symptoms of PONV and pain. EAS is a derivative of acupuncture therapy that uses a small electrical current to stimulate acupuncture points on the human body and is thought to relieve nausea, vomiting and pain. Outcomes measured were post-op questionnaires evaluating pain and nausea symptoms, emetic events, the need for rescue medications and the time to discharge.

COMPLETED
Incidence and Patterns of Nausea/Vomiting With Combined Chemotherapy and Radiation
Description

Questionnaire study to observe the incidence and pattern or nausea and vomiting in patients receiving combined chemotherapy and radiation. 83% of patients experience radiation therapy-induced vomiting; significant nausea and vomiting could develop with concurrent chemotherapy despite standard anti-nauseous medication prophylaxis.

COMPLETED
Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment
Description

The purposes of the study are to determine: i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy iii. To assess the safety of Tigan® in combination with Apokyn® iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated concomitantly with and without Tigan®

COMPLETED
Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant
Description

RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. PURPOSE: This clinical trial is studying how well giving aprepitant together with granisetron and dexamethasone works in preventing nausea and vomiting in patients receiving cyclophosphamide before undergoing an autologous stem cell transplant.

COMPLETED
Trial of Low Residue Diet Versus Clear Liquids Following Elective Colorectal Surgery
Description

Prospective randomized controlled trial investigating commencement of low residue diet versus clear liquids on postoperative zero following elective colorectal surgery, with regards to patient tolerability, incidence of nausea and/or vomiting, and postoperative length of hospitalization stay.

Conditions
UNKNOWN
The Use of Aromatherapy for Symptom Management
Description

The purpose of this pilot study is to introduce the use of aromatherapy/essential oils to medical oncology patients at Central DuPage Hospital to assess their perceived effectiveness to relieve symptoms of nausea or vomiting and/or anxiety. Peppermint oil will be used for nausea/vomiting and lavender oil will be used for anxiety. This study will involve administration of aromatherapy to a convenience sample of patients, who will then be asked to complete a brief questionnaire. The questionnaire will involve a simple likert scale to measure efficacy (in the opinion of the patient) and simple multiple-choice questions to determine patients' likeliness to use aromatherapy again.

COMPLETED
Prospective Controlled Trial On Clear Feeds Versus Low Residue Diet After Surgery In Elective Colorectal Surgery Patients
Description

Prospective randomized controlled trial investigating commencement of low residue diet versus clear feeds on postoperative day one following elective colorectal surgery, with regards to patient tolerability, incidence of nausea and/or vomiting, and postoperative length of hospitalization stay.

Conditions
TERMINATED
Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients?
Description

This is a prospective randomized, double-blind, placebo-controlled study to compare the incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV ondansetron, followed by scheduled Around The Clock (ATC) ondansetron vs. our control group, where pruritus and PONV are treated with PRN only medications.

TERMINATED
Comparative Study of Superficial Cervical Plexus Block and Nerve of Arnold Block and Incidence of PONV for Inner Ear Surgery
Description

The investigators would like to compare the therapeutic and cost effectiveness of established therapies for postoperative nausea and vomiting to regional nerve blocks of the head and neck area an intervention known for analgesia but for which the antiemetic effects hasn't been entirely explored. The rational is based on the knowledge of the anatomical innervation of the inner ear and the role of the parasympathetic nervous system in the emetic act. A lot of focus has been given on its counterpart the sympathetic nervous system and its role in painful conditions. The investigators believe that the nerve blockade of the parasympathetic innervation can have some beneficial effect in the post-surgical patient.

UNKNOWN
Effects of Global Osteopathic Manual Treatments in Patients With Idiopathic Gastroparesis
Description

Global osteopathic manual treatments will decrease the severity score of the Gastroparesis Cardinal Symptom Index tool of patients with idiopathic gastroparesis. In this longitudinal controlled pre-test post-test group design, subjects with idiopathic gastroparesis (IG) will be utilized to see if global osteopathic manual treatments can decrease their symptoms. Patients with IG suffer from varying degrees of nausea, vomiting and abdominal pain secondary to delayed gastric emptying. There is no known cause for people suffering from IG. According to the power analysis, the population will be utilized as the experiment group and the control group. The measuring tool to be used is the Gastroparesis Cardinal Symptom Index (GCSI) which is the most widely used symptom score questionnaire for gastroparesis. The subjects in the population will each fill out the GCSI initially and again after an two (2) week period to measure their symptoms during a control period. The same subjects will then be treated with global osteopathic manual treatments one (1) treatment every two (2) weeks for four (4) weeks (day 1, 14, and 28). The GCSI will be filled out on the day of the first (1st) treatment (which is the last day of the control period) and then two (2) weeks after the last treatment (day 42). In order to reject the null hypothesis, with a p value of \< 0.05 and a power of 0.8, a minimum of ten (10) subjects in the treatment group is required with a treatment effect of 1 or more. A 'Treatment effect of 1' is defined by Cohen's d, where d = mean difference/standard deviation. It is expected that the results will show improvement of symptoms through the data collected from the GCSI questionnaires in the treatment group. The results of this study could be significant and contribute to the osteopathic community validating the effectiveness of traditional osteopathic manual therapy as well as giving non-invasive options to people suffering from the disease since those who struggle with it have minimal treatment options--medicines with significant side effects, full or total stomach removal or gastric electrical stimulator implants.

TERMINATED
The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients
Description

The goal of this study is to determine if acupuncture improves multiple symptoms associated with chemotherapy on the MD Anderson Symptom Inventory (MDASI): nausea, vomiting, fatigue, anxiety, anorexia, pain, disturbed sleep, shortness of breath, dry mouth, depression, and peripheral neuropathy (see statistical section). The investigators hypothesis is that acupuncture will result in lower MDASI scores over the course of chemotherapy for the acupuncture group vs. control group.

COMPLETED
A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients
Description

Aprepitant was approved in 2003. The drug works to lessen the amount of nausea and vomiting that cancer patients experience after treatment. Aprepitant has been well-studied in adults, but not in children. Data from adult studies has shown aprepitant to be safe. It has also been shown to be effective in lessening the amount of nausea and vomiting that adult patients experience. Because aprepitant has been shown to be safe and effective, the investigators have been using it in pediatric patients at this hospital as standard of care. The investigators will be surveying patients already receiving aprepitant for prevention of chemotherapy-induced nausea and vomiting to determine the amount of nausea and vomiting they experience. The investigators will also be surveying these patients to determine what their appetite is like and if they experience any disruptions in activities of daily living. The investigators are also going to be assessing any side effects these patients experience from receiving aprepitant.

COMPLETED
Study of Anesthesia Techniques to Reduce Nausea and Vomiting After Jaw Corrective Surgery
Description

The purpose of this study is to determine whether a multi-modal anesthesia and pain control protocol reduces post-operative and post-discharge nausea and vomiting (PONV and PDNV) in patients undergoing upper jaw corrective surgery.

COMPLETED
Evaluation of the Incidence of Nausea and Vomiting in Patients With Colorectal Cancer Receiving Irinotecan-based Therapy
Description

This is a study to determine how much nausea and or vomiting is caused by irinotecan-based chemotherapy in patients with colorectal cancer. Patients with colorectal cancer scheduled to receive their first cycle of an irinotecan-based chemotherapy regimen are eligible. Any chemotherapy agents administered in combination with irinotecan must have low-minimal potential to cause nausea and or vomiting. Examples of acceptable regimens would be irinotecan in combination with infusional fluorouracil and leucovorin (FOLFRI) with or without bevacizumab and irinotecan in combination with cetuximab. Patients who have received prior non-irinotecan-based chemotherapy are eligible providing they experienced no vomiting and no greater than mild nausea with their prior chemotherapy.

COMPLETED
Aprepitant for PONV Prophylaxis in Outpatient Plastic Surgery
Description

Hypothesis: Aprepitant plus ondansetron is more effective than ondansetron plus placebo for prevention of postoperative emesis in patients at moderate-to-high risk for PONV for up to 48 hours after surgery. Specific Aim: To determine the incidence of PONV during the first 48 hours after surgery; in patients who have received aprepitant plus ondansetron versus ondansetron plus placebo for up to 48 hours after surgery.

COMPLETED
A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department
Description

This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.

Conditions
RECRUITING
A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist Use
Description

The goal of this study is to measure the effects of using Tradipitant after GLP-1R agonist use on nausea and vomiting in healthy overweight, class I, or class II obese volunteers. The study is placebo-controlled with two treatment arms.

Conditions
RECRUITING
A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea and Vomiting in the Bariatric Surgery Population
Description

To assess the effectiveness of Amisulpride to treat Post Operative Nausea and Vomiting (PONV) and to assess the effectiveness of Amisulpride to prevent PONV following bariatric surgery.

RECRUITING
Preoperative Use of Pantoprazole for Prevention of Post Operative Nausea and Vomiting in Gynecologic Surgery
Description

The goal of this clinical trial is to see if pantoprazole (a proton pump inhibitor used for acid reflux/heart burn) can reduce nausea and vomiting after gynecologic surgery in women between the ages of 18 and 79. Researchers will compare a placebo to the active medication. Participants will be asked to take three pills around their surgery, two taken before and one taken the night after.

NOT_YET_RECRUITING
Carbohydrate Fluids and Post Operative Nausea and Vomiting
Description

This study is a prospective randomized clinical controlled trial testing the effects of pre-operative \>50 g pre-operative carbohydrate fluids (apple juice) on a patient's post-operative nausea and vomiting (PONV) incidence and intensity. Optimizing fluid therapy in the peri-operative setting has been proven to improve patient outcomes and reduce complications and length of hospital stay. Based on practice guidelines under the American Society of Anesthesiologists, pre-operative hydration with complex carbohydrate drinks is safe and should be encouraged as it helps with improving metabolism to an anabolic state, decreases insulin resistance, reduces anxiety, and reduces PONV. While pre-operative carbohydrate (CHO) fluids have already been studied and adopted by other surgical specialities (Vascular, General Surgery, Orthopaedics, etc.), this has not yet been studied in oral and maxillofacial surgery, especially at Boston Medical Center (BMC). During surgery, each participant will undergo our current Enhanced Recovery After Surgery "ERAS" protocol, which includes general anesthesia using inhalational gas, judicious IV fluids, intra-operative steroid and ondansetron (anti-emetic), use of 0.5% bupivacaine local anesthesia per quadrant at surgery end time, use of a throat pack, and orogastric/nasogastric (OG/NG) tube suctioning prior to extubation to minimize ingestion of blood. Pain and anxiety medications prior to and during surgery include 2 mg midazolam, fentanyl per anesthesia, toradol, and dexmedetomidine. Having this protocol will help minimize confounding variables that could affect the primary outcome-- incidence and severity of PONV. The objectives for this research are: * To evaluate if pre-operative clear CHO help reduce incidence and intensity of PONV. * To assess if pre-operative clear carbohydrate fluids affect length of hospital stay * To determine if pre-operative CHO reduce patient's pre-/post-operative anxiety * To compare the amount/number of opioids and anti-emetics needed post-operatively between the two groups * To compare ability for patients to return to PO hydration via the amount of fluid ingestion (mL) vs. if they need IV fluids due to decreased PO intake/inability to tolerate PO fluids * To evaluate if patient Apfel score is also a strong indicator for incidence/severity of PONV

RECRUITING
Chronic Nausea and Vomiting in Patients with Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE)
Description

The purpose of this research study is to determine if the Enterra® Therapy System can decrease nausea and vomiting symptoms and improve the quality of life for patients with chronic nausea, with or without vomiting, that have normal gastric emptying.

Conditions