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Intravenous Drug Abuse

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181. Safety of Intravenous Neridronic Acid in CRPS

is to investigate the safety of intravenous neridronic acid in patients with complex regional pain syndrome (CRPS). The trial is divided into 3 periods: a 60-day enrollment period, a treatment period consisting of 4 infusions over 10 days, and a follow-up period of approximately 50 weeks (with visits at Week 2, Week 6, Week 12, Week 26, Week 39, and Week 52). Condition or disease Intervention/treatment Phase Complex Regional Pain Syndrome Drug: Neridronic acid Phase 3 Study Design Go to Layout table for study (...) of Medicine related topics: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: Neridronic acid Neridronic acid 100 mg administered on Day 1, Day 4, Day 7, and Day 10, resulting in a total dose of neridronic acid 400 mg. Drug: Neridronic acid Neridronic acid administered as intravenous infusion. Outcome Measures Go to Primary Outcome Measures : Occurrence of any treatment emergent adverse event [ Time Frame: Day 1 to Week 52 ] The primary endpoint of this trial is a binary

2016 Clinical Trials

182. Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous ETX2514 Administered in Healthy Subjects

Completion Date : June 1, 2017 Arms and Interventions Go to Arm Intervention/treatment Experimental: Part A; Cohort 1: 0.25 g IV ETX2514/placebo Part A of the study will explore the safety and tolerability of a single ascending dose (SAD) of intravenous (IV) ETX2514. Participants in Cohort 1, aged 18 to 55 years, will receive 0.25 grams (g) IV ETX2514/placebo infused over 3 hours. Drug: ETX2514 Drug: Placebo matching placebo infusion Experimental: Part A; Cohort 2: 0.5 g IV ETX2514/placebo Part (...) values are not clinically significant Negative screen for drugs of abuse, alcohol, hepatitis B surface antigen (HBS Ag), hepatitis C virus antibody (HCV Ab), and Human Immunodeficiency Virus (HIV) at screening; and drugs of abuse, alcohol pre dose on Day -1 Female participants must be of non-childbearing potential, or using a medically acceptable contraceptive regimen and must have a negative pregnancy test at Screening (serum) and on Day -1 (urine) prior to study drug dosing. Male participants must

2016 Clinical Trials

183. Intravenous Lidocaine and Postoperative Pain Management

: intravenous lidocaine intravenous lidocaine 1.5mg/kg during induction then infused at 2mg/kg/h until the end of procedure. Drug: Lidocaine lidocaine infusion during surgery Placebo Comparator: saline placebo same amount volume saline infusion Drug: Saline Placebo saline infusion at same rate as intervention group during surgery Outcome Measures Go to Primary Outcome Measures : postoperative pain score [ Time Frame: 6 hours after surgery ] visual analogue score (1-10) postoperative pain score [ Time Frame (...) Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: American Society of Anesthesiologist (ASA) status I-II adult patients undergoing elective laparoscopic cholecystectomy. Exclusion Criteria: Open surgery; Patients allergic to lidocaine or other local anesthetics; Drug abuser. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using

2016 Clinical Trials

184. Comparison of Inhaled Oxytocin (IH) With Intramuscular (IM) Oxytocin in Pregnant Women and With Intravenous (IV) Oxytocin in Healthy Non-pregnant Women

of labour (after the baby is born). Group 2 will enroll non-pregnant women of childbearing potential, who will receive IH oxytocin and intravenous (IV) oxytocin in a cross over design over two dosing sessions This group will evaluate the safety and tolerability of IH and IV oxytocin. Condition or disease Intervention/treatment Phase Postpartum Hemorrhage Drug: IH Oxytocin Drug: IM Oxytocin Drug: IV Oxytocin Device: ROTAHALER Phase 1 Study Design Go to Layout table for study information Study Type (...) product within the following time period prior to the first dosing day in the current study: 30 days or twice the duration of the biological effect of the investigational product (whichever is longer). Exposure to more than four new chemical entities within 12 months prior to the first dosing day. Group 2 Only: Presence of hepatitis B surface antigen or positive hepatitis C antibody test result. A positive Human Immunodeficiency Virus (HIV) antibody test. A positive pre-study drugs of abuse test

2016 Clinical Trials

185. Thorough QT Study of Intravenous Amisulpride

Go to Brief Summary: Randomised, single-dose, crossover, placebo-controlled study to see if intravenous amisulpride has any effect on the heart rhythm, in particular the QT interval, in healthy adult volunteers. Condition or disease Intervention/treatment Phase Healthy Drug: APD421 5 mg Drug: APD421 40 mg Drug: Moxifloxacin Drug: Placebo Phase 1 Detailed Description: Phase 1, randomised, single-dose, period-balanced, crossover, placebo- controlled study to assess the effects of iv doses (...) results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates and methadone) or from the alcohol breath test at screening and on Day −2. History or clinical evidence of alcoholism or drug abuse. Alcohol abuse is defined as regular weekly intake of more than 14 units (Using alcohol tracker http://www.nhs.uk/Tools/Pages/NHSAlcoholtracker.aspx); drug abuse is defined as compulsive, repetitive and/or chronic use of drugs or other substances with or without

2016 Clinical Trials

186. Pilot Study of Bioequivalence of Cudafol(R) and Diprivan(R) Administered as Single Intravenous Doses in Healthy Subjects

2016 Actual Study Completion Date : April 2016 Resource links provided by the National Library of Medicine available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Test product Propofol solution (1% [10 mg/mL]), via intravenous injection Drug: Cudafol(R) (propofol, 1% [10 mg/mL]) Test product Cudafol(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes Active Comparator: Reference product Propofol emulsion (1% [10 mg (...) /mL]), via intravenous injection Drug: Diprivan(R) (propofol, 1% [10 mg/mL]) Reference product Diprivan(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes Outcome Measures Go to Primary Outcome Measures : Bioequivalence based on pharmacokinetic parameter: Area Under Curve [ Time Frame: 0-24 hours post dose ] Bioequivalence based on pharmacokinetic parameter: Cmax [ Time Frame: 0-24 hours post dose ] Secondary Outcome Measures

2016 Clinical Trials

187. Safety Evaluation of Cellavita HD Administered Intravenously in Participants With Huntington's Disease

or severe and uncontrolled cardiovascular disease; Diagnostic of any active infection, be it viral, bacterial, fungal, or caused by another pathogen; Participants who have contraindication to undergo any of the tests performed in this study, for example, have pacemakers or surgical clip; History of alcohol or illegal drugs abusers; History of 1 or more episodes of suicide in the two years before Visit V-4; Active smoker or have stopped smoking less than six months prior to enrollment; Test positive (...) Safety Evaluation of Cellavita HD Administered Intravenously in Participants With Huntington's Disease Safety Evaluation of Cellavita HD Administered Intravenously in Participants With Huntington's Disease - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please

2016 Clinical Trials

188. Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients

hemodialysate and via two different intravenous routes in adult patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, randomized single dose study. Condition or disease Intervention/treatment Phase End Stage Renal Disease Drug: Triferic Phase 1 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 13 participants Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label (...) limit of normal at any time during the two months prior to Baseline. The patient currently has any malignancy other than basal or squamous cell skin cancer. The patient has a history of drug or alcohol abuse within the 6 months prior to Screening. The patient participated in an investigational drug study within 30 days prior to Baseline. The patient has any condition that, in the opinion of the Investigator, would make it unlikely for the patient to complete the study. Contacts and Locations Go

2016 Clinical Trials

189. Safety Study of CD24Fc When Administered Intravenously in Healthy Adult Subjects

Institute of Neurological Disorders and Stroke (NINDS) Information provided by (Responsible Party): OncoImmune, Inc. Study Details Study Description Go to Brief Summary: The purpose of this study is to evaluate the safety and tolerability of single ascending intravenous (IV) doses of CD24Fc in healthy adult subjects. Condition or disease Intervention/treatment Phase Healthy Volunteers Biological: CD24Fc Drug: Saline Phase 1 Study Design Go to Layout table for study information Study Type (...) of the study drug; Subjects who had received any investigational drug or device within 30 days or less than 5 half lives of investigational drug prior to dosing; Subjects taking any prescription or over-the-counter medications within 7 days prior to dosing, or were not willing to refrain from these medications throughout the study period; Subjects who had a history of alcoholism or drug abuse within 2 years prior to dosing; Subjects with a typical consumption of 14 alcoholic drinks weekly; Subjects who had

2016 Clinical Trials

190. Study of the Effects of Intravenous Exenatide on Cardiac Repolarization

Therapeutics Study Details Study Description Go to Brief Summary: Two-Part, Randomized, Placebo and Active-Controlled, Double-Blind, Thorough QT Study Evaluating the Effects of Intravenous Exenatide on Cardiac Repolarization in Healthy Male and Female Volunteers Condition or disease Intervention/treatment Phase Healthy Adult Male and Female Volunteers Drug: Exenatide Drug: Placebo Drug: Moxifloxacin Drug: Palonosetron Phase 1 Detailed Description: This single-center Phase I study will consist of 2 parts (...) surgery. History of malignancy (not including basal or squamous cell carcinoma of the skin with past 5 years). (Subjects who have been disease free for greater than 5 years may be included.) History of active alcohol within 1 year prior to Screening. History of drug abuse within 5 years prior to Screening or a positive prestudy drug screen. Weekly consumption of more than 14 alcoholic beverages for females and more than 21 alcoholic beverages for males. Smoke more than 10 cigarettes per day. Excessive

2016 Clinical Trials

191. A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP6294 Administered Intravenously or Subcutaneously in Healthy Young Male and Female Subjects

doses administrations of ASP6294 as well as determine the maximum tolerated dose (MTD) of single intravenous doses and single sc doses of ASP6294. Part 2 will also evaluate the relative bioavailability of ASP6294 when administered sc. Condition or disease Intervention/treatment Phase Healthy Subjects Pharmacokinetics of ASP6294 Drug: ASP6294 Intravenous Drug: ASP6294 Subcutaneous Drug: Placebo Intravenous Drug: Placebo Subcutaneous Phase 1 Detailed Description: The study consists of two parts: Part (...) , such as available pharmacokinetic and pharmacodynamic data of previous dose levels. Drug: ASP6294 Intravenous Intravenous (IV) Drug: Placebo Intravenous Intravenous (IV) Experimental: Part 2: ASP6294 Single Ascending Subcutaneous Doses A dose escalation design will be implemented. Successive cohorts of patients (8 participants/cohort) will each be started on a fixed dose of ASP6294 or Placebo subcutaneously. The subcutaneous cohorts may be done in parallel with part 1, using doses which have been proven

2016 Clinical Trials

192. To Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Inhaled and Intravenous (IV)Dose Administration

: AZD5634 for inhalation Drug: AZD5634 for infusion Other: Placebo Phase 1 Detailed Description: This study is a Phase I, FIH, randomized, single-blinded (study center staff remain blinded during the dosing phase of the study), placebo-controlled, single ascending dose, sequential dose group study in healthy male subjects and/or female subjects of non-childbearing potential at a single study center to assess AZD5634 following inhaled and intravenous dose administration Study Design Go to Layout table (...) , at screening. Serum/plasma potassium levels are outside the normal range and lower than 3.5 to 5.1 mEq/L (milliequivalents per liter) at screening and prior to dosing. Has active lung disease/asthma that requires treatment. Known or suspected history of drug abuse, as judged by the investigator. Current smokers or those who have smoked or used nicotine products within the previous 3 months. History of alcohol abuse or excessive intake of alcohol, as judged by the investigator. Positive screen for drugs

2016 Clinical Trials

193. A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate

of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 6 months prior to screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits). Subject has an ongoing infection or has had an infection requiring intravenous antibiotics within 1 month prior to day 1. Subject has a known history of a positive test for human immunodeficiency virus (HIV) antibody. Subject has a past history of serious opportunistic infection. Subject has (...) of multiple ascending intravenous doses of ASP5094 in male and female subjects with rheumatoid arthritis (RA) on methotrexate (MTX). Condition or disease Intervention/treatment Phase Rheumatoid Arthritis (RA) Drug: ASP5094 Drug: Placebo Phase 1 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 30 participants Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double (Participant, Investigator) Primary Purpose

2016 Clinical Trials

194. Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD

with Inflammatory Bowel Disease (IBD). Condition or disease Intervention/treatment Phase Anemia, Iron-Deficiency Inflammatory Bowel Disease Crohn's Disease Drug: Ferric Maltol Drug: Ferric Carboxy Maltose Phase 3 Detailed Description: A phase 3b, randomized, controlled, multicentre study with oral ferric maltol or intravenous iron (FCM), for the treatment of iron deficiency anaemia in subjects with inflammatory bowel disease. Approximately 242 eligible subjects will be randomised (1:1) to receive one (...) iron compound 30 mg capsules to be taken orally twice a day for 52 weeks Drug: Ferric Maltol Other Names: Feraccru Ferric Trimaltol ST10 ST10-01 Active Comparator: Intravenous iron Administered as per the local summary of product characteristics (SPC) Drug: Ferric Carboxy Maltose Outcome Measures Go to Primary Outcome Measures : Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (>12g/dL women, >13g/dL men) at Week 12 [ Time Frame: Baseline to Week 12 ] Secondary

2016 Clinical Trials

195. Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy

, 2018 See Sponsor: Mahidol University Information provided by (Responsible Party): Sirilak Suksompong, Mahidol University Study Details Study Description Go to Brief Summary: Nowadays, TRUS biopsy become one of the most popular tests for diagnosis of prostate cancer. This procedure causes pain to the patients who does not received the sedative drugs or analgesic drugs. There are many ways to reduce pain and inconvenience for the patients, such as intravenous propofol, intravenous fentanyl etc (...) . In Siriraj hospital, anesthesiologists usually give intravenous propofol with intravenous opioids but the visual analogue score after this procedure was average at 0.9-2.9. Furthermore, some systematic reviews have shown that there was no difference in pain score between periprostatic nerve block plus opioid and periprostatic nerve block only. So, this study is to find out whether opioids is need for TRUS biopsy. Condition or disease Intervention/treatment Phase Pain Other: Control Drug: Fentanyl Drug

2016 Clinical Trials

196. The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes

Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Drug: IGIV-C Drug: 0.9% Sodium Chloride Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 20 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment Official Title: A Double-Blind, Randomized, Placebo-Controlled Trial To Evaluate The Efficacy Of Intravenous (...) MeSH terms: Layout table for MeSH terms Diabetes Mellitus Peripheral Nervous System Diseases Diabetic Neuropathies Diabetes Complications Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Neuromuscular Diseases Nervous System Diseases Immunoglobulins Antibodies gamma-Globulins Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunoglobulin G Immunologic Factors Physiological Effects of Drugs

2016 Clinical Trials

197. Low Dose Intravenous Ketamine in Treatment Resistant Depression Patients

Investigation of Neurophysiological Correlates of Low Dose Intravenous Ketamine in Treatment Resistant Depression Patients Study Start Date : September 2016 Estimated Primary Completion Date : September 2019 Estimated Study Completion Date : September 2019 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Ketamine Slow infusions of ketamine will take place over a time period of 40 minutes. Drug (...) Verified: May 2018 Additional relevant MeSH terms: Layout table for MeSH terms Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Behavioral Symptoms Mood Disorders Mental Disorders Ketamine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter

2016 Clinical Trials

198. Safety, Tolerability and Pharmacokinetics of APX001 Administered Intravenously

Completion Date : July 2017 Arms and Interventions Go to Arm Intervention/treatment Experimental: Cohort 1 single intravenous dose Drug: APX001 single dose 1 Drug: Matching Placebo Experimental: Cohort 2 single intravenous dose Drug: APX001 single dose 2 Drug: Matching Placebo Experimental: Cohort 3 single intravenous dose Drug: APX001 single dose 3 Drug: Matching Placebo Experimental: Cohort 4 single intravenous dose Drug: APX001 single dose 4 Drug: Matching Placebo Experimental: Cohort 5 single (...) intravenous dose Drug: APX001 single dose 5 Drug: Matching Placebo Experimental: Cohort 6 single intravenous dose Drug: APX001 single dose 6 Drug: Matching Placebo Experimental: Cohort 7 multiple intravenous doses Drug: APX001 multiple dose 1 Drug: Matching Placebo Experimental: Cohort 8 multiple intravenous doses Drug: APX001 multiple dose 2 Drug: Matching Placebo Experimental: Cohort 9 multiple intravenous doses Drug: APX001 multiple dose 3 Drug: Matching Placebo Experimental: Cohort 10 multiple

2016 Clinical Trials

199. Intravenous Lidocaine for Cystectomy Procedures

Comparator: Lidocaine Study Group Intravenous Lidocaine for Cystectomy Procedures: During the surgery, the lidocaine infusion group will receive the lidocaine bolus (1.5mg/kg bolus followed by a 2mg/kg/h infusion) 30 minutes prior to skin incision and the infusion will continue until 60 minutes after skin closure. Procedure: Cystectomy Drug: Lidocaine Patients will receive lidocaine infusion during surgery Placebo Comparator: Placebo Study Group Intravenous Saline for Cystectomy Procedures: During (...) Intravenous Lidocaine for Cystectomy Procedures Intravenous Lidocaine for Cystectomy Procedures - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Intravenous Lidocaine for Cystectomy Procedures (Lidocaine

2016 Clinical Trials

200. Multicenter Study to Compare Intravenous and Oral Acetaminophen for the Treatment of Acute Moderate to Severe Pain

, Postoperative Drug: IV acetaminophen Drug: Oral acetaminophen Drug: Morphine Phase 4 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 1 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment Official Title: A Randomized, Double-Blind, Double-Dummy, Active-Controlled, Repeated Dose, Multicenter Study to Compare Intravenous and Oral Acetaminophen (...) to day-of-surgery or plans to participate in another clinical study while concurrently enrolled in this study. Subject has a history of conditions which might be specifically contraindicated or require caution to be used during the administration of any drug in the study. Subject has any other medical, psychiatric and/or social reason for exclusion as determined by the investigator. Subject has a positive test result for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids

2016 Clinical Trials

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