ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02058303
Conditions: Hand Injuries Wrist Injuries Finger Injuries
Keywords: hand surgery wrist surgery finger surgery anesthesia regional anesthesia postoperative pain
Sponsor: Jose Soberon, MD
Start date: 2014-02-01; Completion date: 2016-03-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare Exparel, a new, long-lasting numbing medication and a shorter-acting nerve block to a traditional single-shot nerve block in patients having hand, wrist or finger surgery.

Detailed description:

Arms: arm 1: Under ultrasound guidance, 3-5 milliliters (mL) Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. arm 2: Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block.
Interventions: intervention 1: Exparel Forearm block intervention 2: Bupivacaine supraclavicular block
Intervention descriptions: intervention 1: 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block. intervention 2: 20-30mL 0.5% bupivacaine

Protocol documents:
Clinical trial NCT02069093
Conditions: Advanced Breast Cancer
Sponsor: Novartis Pharmaceuticals
Start date: 2014-05-01; Completion date: 2016-03-01
Enrollment: 92 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Open-label, Phase II study of Stomatitis prevention with a steroid-based mouthwash in Post-menopausal women with ER+, HER2- Metastatic or Locally Advanced Breast Cancer

Detailed description:

Arms: arm 1: Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
Interventions: intervention 1: Dexamethasone based mouthwash intervention 2: Everolimus intervention 3: Exemestane
Intervention descriptions: intervention 1: Dexamethasone steroid-based oral solution, comprised of 0.5 milligrams per 5mL of alcohol-free dexamethasone. intervention 2: Commercially available everolimus 10 mg was prescribed to participants by the Investigator according to local regulations. intervention 3: Commercially available exemestane 25 mg was prescribed to participants by the Investigator according to local regulations.

Protocol documents:
Clinical trial NCT02088177
Conditions: Cannabis Dependence
Keywords: Cannabis Cannabis Dependence Cannabis Use Disorder Marijuana Naltrexone Long Acting Injectable Naltrexone Treatment
Sponsor: New York State Psychiatric Institute
Start date: 2014-10-01; Completion date: 2016-03-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an 8 week, outpatient research study testing the use of long-acting naltrexone (Vivitrol) as a treatment for marijuana dependence. Vivitrol is a medication that is effective in treating dependence on opiates and opioids, and in treating dependence on alcohol. It is FDA approved for these disorders. It is a long-acting medication that contains enough medicine in each injection to last for one month. One way it works is by blocking the effects of opiates, including opiates released by the body in response to drugs and alcohol. In this study, we are interested in testing the effects of Vivitrol in people with marijuana dependence.

Individuals participating in this study will receive two Vivitrol injections, each given four weeks apart, (week 1 and week 5). The injection is given in the muscle of the buttock on one side. Participants will attend clinic visits two times a week during this 8-week study for medical management for drug use and for monitoring of physical and psychological health.

Detailed description:
This is an 8 week, outpatient, open-label clinical trial of long-acting injectable naltrexone as a treatment for cannabis dependence.

The purpose of the study will be to evaluate marijuana use patterns and tolerability of long-acting naltrexone in 7 treatment-seeking, cannabis-dependent outpatients; also to assess feasibility of conducting a larger trial with this medication. Cannabis dependent patients will have twice weekly clinic visits where they will receive injections of Vivitrol four weeks apart, in Week 1 and in Week 5. The psychosocial intervention for this study will be Medical Management, designed to facilitate adherence to the study medication and monitoring procedures, as well as to support the participant in achieving his or her marijuana use goals.

Participants will self-report cannabis use, will provide urine toxicology for quantitative assessment of THC (Tetrahydrocannabinol, the active ingredient in marijuana), and will provide serum samples for safety monitoring, and will answer questionnaires and will report on their physical and psychological health weekly.

Arms: arm 1: Two doses of long-acting injectable naltrexone, 380 mg by intramuscular injection in the gluteal muscle at study day 1 and again between study days 28-30.
Interventions: intervention 1: Long-acting injectable naltrexone
Intervention descriptions: intervention 1: Vivitrol is a long-acting opioid antagonist which blocks opioid agonists from binding at opioid receptors. It be administered as described above.

Protocol documents:
Clinical trial NCT02103855
Conditions: Nephrotoxicity
Keywords: pancreas transplantation immunosuppression belatacept
Sponsor: Indiana University
Start date: 2014-06-01; Completion date: 2016-03-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Kidney damage is a major complication of current antirejection medicines used in transplantation. An increasing number of brittle diabetics are successfully receiving a pancreas transplant. One of the challenges following pancreas transplant is that a patient can develop kidney damage from one of their antirejection medicines, tacrolimus. The objective of this study is to substitute a new antirejection medicine which does not cause kidney damage, belatacept for tacrolimus in patients that have developed signs of tacrolimus related kidney damage to slow the progression of kidney disease.

Detailed description:
Nephrotoxicity is a major complication of current immunosuppression regimens used in transplantation. Pancreas transplantation has been increasedly performed to manage labile diabetes mellitus during the last few decades and survival rates of pancreatic grafts are improving. One of the challenges that is faced following pancreas transplantation alone are pathologic changes from diabetes frequently seen in native kidneys in the pancreas transplant recipients. High levels of calcineurin inhibitors (CNI) have been identified as risk factors for decline in kidney function and progression to end-stage renal disease. The objective of this trial is to take subjects who have biopsy proven CNI toxicity off of their CNI and begin belatacept, which is not a CNI.

The hypothesis is by switching the pancreas transplant subject with documented CNI kidney toxicity to belatacept will slow the progression of chronic kidney disease.

Arms: arm 1: Belatacept 5 mg/kg IVPB q 2 wks x 5 doses followed by 5 mg/kg IVPB q month. The belatacept dose will be infused IV over 30 minutes.

Day 14: Reduce tacrolimus dose by 25% Day 30: Reduce tacrolimus dose by additional 25% Day 45: Reduce tacrolimus dose by additional 25% Day 60: Stop tacrolimus.
Interventions: intervention 1: Belatacept
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02125604
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Gastrointestinal event
Sponsor: Biogen
Start date: 2014-06-01; Completion date: 2016-03-01
Enrollment: 214 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal-related events reported by participants with relapsing-remitting multiple sclerosis initiating therapy with BG00012 (dimethyl fumarate, DMF) in the clinical practice setting.

The secondary objectives of this study in this study population are as follows: to evaluate gastrointestinal-related events requiring symptomatic therapy and the role of those therapies over time; to evaluate gastrointestinal-related events that lead to a physician's decision to manage the events with BG00012 dose modification; and to evaluate gastrointestinal-related events that lead to BG00012 discontinuation after the use of symptomatic therapy.

Detailed description:

Arms: arm 1: Dimethyl fumarate administered orally at 120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
Interventions: intervention 1: dimethyl fumarate
Intervention descriptions: intervention 1: capsules administered according to the prevailing product label

Protocol documents:
Clinical trial NCT02155309
Conditions: Motion Sickness
Keywords: scopolamine motion sickness
Sponsor: Repurposed Therapeutics, Inc.
Start date: 2014-06-01; Completion date: 2016-03-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Part 1, the pharmacokinetic (PK) phase, will expand upon the pilot study conducted at Naval Medical Research Laboratory (NAMRL) and has the goal of determining bioavailability and time to Cmax in a larger representative sample. Part 2, the efficacy phase, is to determine the efficacy of the aqueous spray solution via exposure to a nausea-inducing stimulus.

Detailed description:
Part 1: The pharmacokinetic (PK) phase Objective: To determine the bioavailability and amount of scopolamine absorbed after administration of 0.2 mg intranasal scopolamine at regular intervals across 8 hours post- dose.

Hypothesis: Detectable levels of Intranasal scopolamine (INSCOP) will be present in subject plasma within 15 minutes post-dose; mean time to Cmax (maximum plasma concentration) will be less than 1.5 hr.

Part 2: The Efficacy phase Objective: To determine the effectiveness, cognitive performance effects, and medication side-effect profile of 0.2 mg intranasal scopolamine spray as a motion sickness (MS) countermeasure.

Hypothesis: The primary hypothesis is that the INSCOP spray will be more efficacious against MS than placebo, without statistically significant cognitive performance side-effects. Specifically, participants will tolerate significantly more provocative head tilts in the INSCOP condition than in the placebo condition.

Arms: arm 1: 0.2 mg intranasal scopolamine, single dose arm 2: placebo intranasal (0.1 mg per nostril), single dose
Interventions: intervention 1: Scopolamine intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02200328
Conditions: Clostridium Difficile Diarrhea
Keywords: Clostridium difficile infection Diarrhea Flagyl Metronidazole
Sponsor: Alison Schneider
Start date: 2014-08-01; Completion date: 2016-03-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among patients at high risk for this infection.

Detailed description:
Clostridium Difficile infection or C. Diff (CDI) is an infection that causes severe diarrhea. Risk factors for this infection include hospitalization, the use of antibiotics, along with medications that decrease the acid in the stomach. This infection leads to a disease which is difficult to treat and can cause serious complications including death in rare cases. This infection also increases medical costs by prolonging hospital stays.

Metronidazole (known by the brand name Flagyl) is an antibiotic that has been available for decades and has been used to treat this disease. Flagyl is approved by the Food and Drug Administration for the treatment of C. diff infection. Recent research by the investigators group has shown that hospitalized patients who took Flagyl had a decreased chance of getting C. Diff infection. However, high quality studies are needed to better evaluate whether the investigators can prevent C. Diff infection in high risk patients with the use of Flagyl.

The purpose of this study is to assess if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among inpatients at high risk for this infection.

High risk patient population are as defined below: taking a broad spectrum antibiotics (piperacillin/tazobactam-Zosyn; Ciprofloxacin).

Arms: arm 1: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days arm 2: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days
Interventions: intervention 1: Metronidazole intervention 2: Placebo
Intervention descriptions: intervention 1: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days intervention 2: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days

Protocol documents:
Clinical trial NCT02207621
Conditions: Ocular Hypertension Open-angle Glaucoma
Keywords: Glaucoma
Sponsor: Aerie Pharmaceuticals
Start date: 2014-07-01; Completion date: 2016-03-01
Enrollment: 756 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluation of the ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution

Detailed description:

Arms: arm 1: 1 drop AR-13324 in the evening (PM) \& 1 drop placebo in the morning (AM) in both eyes (OU) arm 2: 1 drop twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) arm 3: 1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU)
Interventions: intervention 1: AR-13324 Ophthalmic Solution 0.02% intervention 2: Timolol maleate Ophthalmic Solution 0.5% BID intervention 3: Placebo intervention 4: AR-13324 Ophthalmic Solution 0.02% BID
Intervention descriptions: intervention 1: 1 drop once daily (QD), PM, OU intervention 2: 1 drop BID, AM/PM, OU intervention 3: 1 drop QD, AM, OU intervention 4: 1 drop BID, AM/PM, OU

Protocol documents:
Clinical trial NCT02212197
Conditions: Prostate Cancer
Keywords: prostate cancer leuprolide
Sponsor: Camurus AB
Start date: 2014-09-01; Completion date: 2016-03-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and safety of CAM2032 versus Eligard, in patients with prostate cancer. All patients will receive leuprolide acetate administered subcutaneously once monthly during 3 months.

Detailed description:

Arms: arm 1: Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56. arm 2: Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56. arm 3: Single subcutaneous buttock injections of Eligard® (leuprolide acetate) 7.5 mg on Days 0, 28 and 56.
Interventions: intervention 1: leuprolide acetate FluidCrystal® injection depot intervention 2: leuprolide acetate
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02217280
Conditions: Cervical Radiculopathy
Keywords: Cervical Radiculopathy
Sponsor: University of Missouri-Columbia
Start date: 2015-04-01; Completion date: 2016-03-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will analyze injectate dispersal patterns after standard-of-care cervical epidural steroid injections using gadolinium as a marker and magnetic resonance imaging (MRI) to characterize the pattern. Although these procedures are performed with high frequency under the assumption that injectate remains localized to injection site, no peer-reviewed studies have validated this assumption. Comprehensive characterization of injectate dispersal patterns will provide important data regarding safety, as well as diagnostic and therapeutic potential of cervical epidural steroid injections.

Detailed description:
Epidural steroid injections have long had an impact in the treatment of various spine-related conditions, particularly radiculopathy. The efficacy of epidural spinal injections has been attributed to the anatomic location reached by the injectate. Cervical epidural steroid injections are also used as an injury location indicator. This application is based on documenting pain relief after injection into a specific location in the cervical spine. Both the diagnostic and therapeutic applications for epidurals assume that the injectate remains local to the injection site in order to have its effects. However, in a recently completed study, the investigators group documented substantial diffusion of injectate after lumbar epidurals used computerized tomography (CT) assessments.1 Based on the exposure to ionizing radiation associated with CT along with the superior imaging specificity and sensitivity of MRI, the investigators are shifting their imaging modality to MRI for future studies. The proposed study is designed to evaluate the use of gadolinium and MRI to assess nature and amount of diffusion of injectate in the cervical region after standard-of-care epidural injections. To the investigators knowledge, this will be the first study to critically assess this common procedure in order to evaluate safety and efficacy in a clinical setting.

Arms: arm 1: This group of patients identified by the PI as having cervical radiculopathy will receive gadolinium (the intervention) in their epidural cervical injection along with steroid (DepoMedrol). There is no control group in this study.
Interventions: intervention 1: Injection with Gadolinium
Intervention descriptions: intervention 1: Gadavist (gadobutrol) injection is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system

Protocol documents:
Clinical trial NCT02219087
Conditions: Osteoarthritis, Knee
Keywords: Total knee arthroplasty Total joint arthroplasty Knee replacement Osteoarthritis of the knee
Sponsor: OhioHealth
Start date: 2014-08-01; Completion date: 2016-03-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total knee arthroplasty, as compared to standard of care analgesia.

Detailed description:
Liposomal bupivacaine (Exparel®) is a local anesthetic made up of liposomal encapsulated bupivacaine. It is designed to be injected at the time of surgery into the local soft tissues. Because of its unique liposomal delivery system, Liposomal bupivacaine (Exparel®) has been shown to provide up to 96 hours of pain relief following surgeries. This makes it an attractive option in total knee arthroplasty patients. Combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended pain relief following total knee arthroplasty. This has the potential to avoid the need for opioid medications. With better pain control, medication side effects can be avoided and patient's length of stay in the hospital can be shortened.

Arms: arm 1: Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Liposomal bupivacaine (diluted to 60mL): 20mL into the posterior pocket, 20mL into the lateral, and 20mL into the medial, including all deep and superficial tissues of these areas. arm 2: Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.
Interventions: intervention 1: Liposomal bupivacaine intervention 2: Standard of Care
Intervention descriptions: intervention 1: None intervention 2: Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.

Protocol documents:
Clinical trial NCT02224664
Conditions: Parkinson's Disease
Sponsor: Pfizer
Start date: 2014-10-01; Completion date: 2016-03-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
This study will be an open label, dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeated daily quaque die (QD) doses given over 21 days (Day 3 to Day 23) to sequential cohorts of subjects with Parkinson's disease. Each cohort will have 2 study periods. For each cohort, subjects will enter Period 1 and if they meet criteria, approximately 12 subjects will be enrolled into Period 2 and dosed with PF 06649751. Based on results observed in a previous study, Cohorts 1 and 2 will not be conducted. Cohorts 3 - 6 will test doses uptitrated to 5 mg, 15 mg and 25 mg QD. Doses may be modified based on emerging safety, tolerability and PK data, but the maximum daily dose that will be given in any cohort will have PK predictions at steady state that are anticipated to be below toxicokinetic limits. An option for down titration to the previous dose level is available should the investigator consider that an AE is intolerable. Following down titration, a single up titration to the next dose level may be attempted if the subject remains symptom free for at least 48 hrs. Safety, tolerability and PK data of Cohort 3 will be reviewed prior to initiating the dosing in Cohorts 4 and 5. Available safety, tolerability and PK data up to Day 24 of at least 5 subjects from Cohorts 4 will be reviewed prior to initiating the dosing in Cohort 6.

Detailed description:

Arms: arm 1: Titration of PF-06649751 up to 5 mg QD arm 2: Titration of PF-06649751 up to 15 mg QD arm 3: Titration of PF-06649751 up to 15 mg QDi n subjects with Levodopa-induced dyskinesias (LID) arm 4: Titration of PF-0649751 up to 25 mg QD
Interventions: intervention 1: PF-06649751 intervention 2: PF-06649751 intervention 3: PF-06649751 intervention 4: PF-06649751
Intervention descriptions: intervention 1: Oral daily doses titrated up to 5mg QD intervention 2: Oral daily doses titrated up to 15 mg QD intervention 3: Oral daily doses titrated up to 15 mg QD (slow titration with option to down titrate) intervention 4: Oral daily doses titrated up to 25 mg QD

Protocol documents:
Clinical trial NCT02227849
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2014-08-01; Completion date: 2016-03-01
Enrollment: 71 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with GLP-1 analogue in patients with type 2 Diabetes for 52 weeks.

Detailed description:
This is an open-label study to evaluate the long-term safety and efficacy of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with GLP-1 analogue on diet and exercise and have inadequate glycemic control. The patients will receive TA-7284 100mg orally for 52 weeks.

Arms: arm 1: None
Interventions: intervention 1: Canagliflozin (TA-7284) intervention 2: GLP-1 analogue
Intervention descriptions: intervention 1: The patients will receive Canagliflozin orally for 52 weeks intervention 2: None

Protocol documents: