There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This is the first study of pomaglumetad in humans using methamphetamine. The goal of the study is to determine if pomaglumetad is safe when administered with methamphetamine. If shown to be safe with methamphetamine in the current study, a phase 2 clinical trial of pomaglumetad would be done to begin to find out if pomaglumetad is effective in treating methamphetamine use disorder.
Skeletal muscle abnormalities (sarcopenia) and frailty are common complications seen in patients with end-stage liver disease. The presence of these complications portends poor prognosis. The purpose of this study is to assess the impact of a formal home based video strengthening program (REST) on sarcopenia and frailty. We also want to assess the impact of this exercise program on complication rates, hospitalization, on quality of life (QOL) and on survival.
The study will focus on survivorship care for head and neck cancer patients cared for within Duke Cancer Center clinics. Standardized survivorship care plans (sSCP) are being implemented based on the American Society for Clinical Oncology's criteria. These documents provide a summary of treatment received, and list side effects and follow-up information after cancer treatment. Taking advantage of this transition, the investigator will study three groups of patients: (a) early survivors treated before the sSCP was implemented, (b) early survivors treated after the sSCP was implemented, and (c) current patients who will receive an individualized enhanced SCP (eSCP), which will include additional information tailored to patient preferences. The investigators hypothesize that patients receiving enhanced survivorship care plans will increase their knowledge regarding their health care plan and wellness trajectory; increase their ability to identify the symptoms they most likely can expect as a result of their cancer treatment; and be more likely to engage in conversations with their PCP about healthy behaviors and screening guidelines.
Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. This is the first study of cadazolid in children. The overall purpose of this study is to provide reassurance on the safety and efficacy of cadazolid in children suffering from infection due to Clostridium difficile.
This study will assess the tolerability and palatability of an amino acid based oral rehydration solution (enterade®) compared to current oral rehydration solution among children with short bowel syndrome .
This is a double-blinded study involving healthy non-alcoholic (self-reported) volunteers over the age of 21. Consent is obtained prior to participation in the study while the participant is sober. Volunteers are recruited from residency programs, hospital employees, emergency medical personnel, and friends of the study investigators. If the volunteers choose to drink, they can participate in the study the night of ingestion of alcohol. There is no amount we ask them to drink, and we allow them to withdraw from the study at any time. We never force them to drink alcohol, or even encourage it. The participation is completely voluntary, if they would like to participate and if they choose to drink alcohol, we ask them to participate in the placebo controlled study in the safety of their own home. Then materials for the study are given out prior to their participation. An envelope is given with the questionnaire, and a small packet containing 3 pills of either NAC or placebo, and a small smear of Vicks vapor rub concealed in a small packet. At the end of their alcohol ingestion, the volunteer is asked to estimate the number roof drinks consumed and take 1 capsule per 3 drinks consumed of either 600 mg N-Acetyl-L-Cysteine or placebo capsules. In the morning, each participant fills out a Hangover Symptom Score questionnaire . A random number generator is used to determine placebo or NAC first, then the participant is given the other treatment at their subsequent encounter. Then study is being conducted over a series of many months, and data can be analyzed by the hangover symptoms scale data when using NAC compared to placebo. The data will be analyzed using the numerical values of each category for hangover classification and compare the placebo data to the control data.
Simple explanation and rationale: Recovery after spine surgery is usually accompanied by severe pain which has traditionally been managed with opioids. It is common practice to supplement opioid treatment with different classes of analgesics which work through alternative pain pathways and receptors in order to achieve an additive or synergistic effect while reducing the amount of opioids necessary for pain control. Acetaminophen can be a beneficial supplemental analgesic to opioids for postoperative pain relief. Intervention: Patients will be randomized to either the treatment with IV acetaminophen (A), PO acetaminophen (B), or hydromorphone control group (C). Objective/Purpose: Primary objective is to determine the impact of administering a supplemental non-opioid analgesic drug such as IV or PO acetaminophen on total opioid dose administered over the postoperative period. Secondary objectives include investigating the impact of IV/PO acetaminophen on the level of postoperative pain, patient satisfaction, and side effects secondary to opioids such as nausea, vomiting, pruritus, sedation, respiratory depression, ileus, and urinary retention, and PACU (postoperative care unit) discharge time. Study population: 126 patients will be enrolled in the study (42 for group A, 42 for group B, and 42 for control group C). Follow-up and Endpoints / Outcomes: Postoperative assessments will be done at 0, 30, and 60 minutes, 6 hours, 12 hours and 24 hours after surgery. Patients will be evaluated for pain (using a numeric rating scale), total opioid consumption, and for opioid side effects including drowsiness (using the Ramsey sedation scale and the Aldrete score at the time of arrival to and discharge from recovery room), respiratory depression, nausea, vomiting, and pruritus. Patient satisfaction will also be assessed using a numeric rating scale.
Background: Parkinsons disease (PD) causes slow movement, stiffness, and poor balance. Many symptoms are due to the loss of brain cells that make the brain chemical dopamine. The cells may be damaged by the breakdown of dopamine by a process called oxidation. The drug N-acetylcysteine (NAC) can act as an antioxidant. Researchers want to test if NAC can decrease the oxidation of brain dopamine in people with PD. Objective: To look at the effect of NAC on brain chemistry in people with PD. Eligibility: People ages 18 and older with PD that were diagnosed within the past 5 years. They must be taking a monoamine oxidase inhibitor. Healthy volunteer participants ages 18 and older. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Participants will be hospitalized for 4 to 8 days. On day 1, participants will have blood and urine tests. For several hours, they cannot eat or drink anything but water and their medications. Late in the morning they will have a meal. About 2 hours later they will have a spinal tap (lumbar puncture). For this, a numbing medicine is injected into the back. A needle is inserted between the bones in the back to remove a small amount of fluid. The spinal tap may use x-rays to see inside the body. After the spinal tap, they will start taking NAC by mouth. They will take NAC twice a day for 2 more days. On the next day, they will not eat until a meal in the late morning. They will take a final NAC dose. About 2 hours later they will have a second spinal tap. Healthy Volunteer (HV) participants will receive a spinal tap on day one, followed by a second spinal tap 48 hours after the first spinal tap. HV participants will not receive NAC.
Despite the recent introduction of novel anti-multiple myeloma (MM) agents, high risk MM remains with poor prognosis and a therapeutic challenge. Elotuzumab (ELO) is a humanized monoclonal antibody that recognizes CS1/CD139, a molecule highly expressed in MM cells. The ELO (10 mg/kg), lenalidomide (LEN) and dexamethasone (DEX) combination achieves high overall response rates (ORR) and long progression-free survival (PFS) for patients with relapsed/refractory disease (RR) MM and those with impaired renal function. However, its efficacy for MM patients with high risk characteristics is still unknown. Pomalidomide (POM) is a recently approved immunomodulatory agent (IMiD) that produces response rates for high-risk RRMM patients when used in combination with DEX and other agents, including the proteasome inhibitor (PI) bortezomib (BTZ). POM has also demonstrated activity for LEN refractory patients. Carfilzomib (CFZ) is a potent second generation PI that has shown to be efficacious for IMiD and BTZ refractory patients as well as high risk patients carrying cytogenetic abnormalities. In this study, we propose to evaluate efficacy and safety of ELO in combination with POM, DEX and CFZ for high-risk RRMM patients.
This phase I trial studies the side effects of huJCAR014 in treating patients with relapsed or refractory B-cell non-Hodgkin lymphoma or acute lymphoblastic leukemia. huJCAR014 CAR-T cells are made in the laboratory by genetically modifying a patient's T cells and may specifically kill cancer cells that have a molecule CD19 on their surfaces. In Stage 1, dose-finding studies will be conducted in 3 cohorts: 1. Aggressive B cell NHL 2. Low burden ALL 3. High burden ALL In Stage 2, studies may be conducted in one or more cohorts to collect further safety, PK, and efficacy information at the huJCAR014 dose level(s) selected in Stage 1 for the applicable cohort(s). There are two separate cohorts for stage 2: 1. Cohort 2A, CAR-naïve (n=10): patients who have never received CD19 CAR-T cell therapy. 2. Cohort 2B, CAR-exposed (n=27): patients who have previously failed CD19 CAR-T cell therapy.