ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02295553
Conditions: Anesthesia
Keywords: Ketamine Propofol Children Pediatrics Upper endoscopy
Sponsor: The Hospital for Sick Children
Start date: 2013-07-01; Completion date: 2016-12-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the dose-response relationship of ketamine in combination with propofol.

Detailed description:
Direct visualization of the esophagus, stomach and small intestine is performed using a scope that is inserted while the patient is under under deep sedation or general anesthesia. The most common method of providing general anesthesia for upper endoscopy is intravenous administration of medications such as propofol, often in combination with other medications such as fentanyl, midazolam, remifentanil or ketamine. One study found that the combination of propofol and ketamine provides better conditions (less patient movement, more stable heart and breathing) but more side effects afterwards compared to propofol and fentanyl.

Arms: arm 1: Ketamine dose will be 0 mg/kg. Propofol dose for the first patient will be 4 mg/kg. Doses for the subsequent patients will increase or decrease by 1.6 mg/kg using the Dixon Up and Down method. arm 2: Ketamine dose will be 0.25 mg/kg. Propofol dose for the first patient will be 3 mg/kg. Doses for the subsequent patients will increase or decrease by 1.2 mg/kg using the Dixon Up and Down method. arm 3: Ketamine dose will be 0.5 mg/kg. Propofol dose for the first patient will be 2.5 mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method. arm 4: Ketamine dose will be 1.0 mg/kg. Propofol dose for the first patient will be 2 mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.
Interventions: intervention 1: Ketamine intervention 2: Propofol
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02296190
Conditions: Paroxysmal Supraventricular Tachycardia (PSVT)
Sponsor: Milestone Pharmaceuticals Inc.
Start date: 2015-03-27; Completion date: 2016-12-01
Enrollment: 199 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to demonstrate the superiority of at least 1 dose of intranasal (IN) MSP-2017 (Etripamil) over placebo in terminating PSVT induced in an electrophysiology (EP) laboratory.

Detailed description:
This is a multi-center, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the effects of 4 different doses of MSP-2017 (Etripamil) in subjects with paroxysmal supraventricular tachycardia. It includes an up to 21-day Screening Period, a 1-day Treatment Visit, and either a Follow-up Visit or Early Termination Visit occurring 12 hours to 5 days after the Treatment Visit. Subjects will be randomized to yield at least 100 evaluable subjects distributed into 5 groups of at least 20 subjects each.

Arms: arm 1: 1 dose of Etripamil via 4 intranasal applications at time 0 (140 mg, 105 mg, 70 mg, or 35 mg) arm 2: 1 dose of placebo via 4 intranasal applications at time 0
Interventions: intervention 1: Etripamil intervention 2: Placebo
Intervention descriptions: intervention 1: intranasal administration via 4 prefilled Aptar Pharma Unit-Dose Spray devices intervention 2: intranasal administration via 4 prefilled Aptar Pharma Unit-Dose Spray devices

Protocol documents:
Clinical trial NCT02297503
Conditions: Facial Aesthetic Treatment
Sponsor: Galderma R&D
Start date: 2014-11-01; Completion date: 2016-12-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.

Detailed description:

Arms: arm 1: Azzalure alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12. arm 2: HA filler alone as single treatment at initial treatment followed by two combined treatments with Azzalure, HA filler and Skinboosters at Month 6 and Month 12.
Interventions: intervention 1: Azzalure intervention 2: Restylane/Emervel filler intervention 3: Restylane Skinbooster
Intervention descriptions: intervention 1: Glabellar lines intervention 2: Facial tissue augmentation intervention 3: Facial skin rejuvenation

Protocol documents:
Clinical trial NCT02303262
Conditions: Metastatic Leiomyosarcoma
Sponsor: Sarcoma Alliance for Research through Collaboration
Start date: 2015-11-12; Completion date: 2016-12-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multi-center, Phase II trial studying the combination of mocetinostat and gemcitabine in patients who have previously demonstrated disease progression either while, or within six months after, receiving chemotherapy with a gemcitabine-based regimen.

Detailed description:

Arms: arm 1: For each 21-day cycle, gemcitabine is administered on days 5 and 12 and mocetinostat is administered 3 days a week.
Interventions: intervention 1: Mocetinostat intervention 2: Gemcitabine
Intervention descriptions: intervention 1: Mocetinostat is taken orally at 70 mg/dose, 3 days per week, during cycle 1. Dose is increased to 90 mg starting at cycle 2. intervention 2: Gemcitabine is administered via intravenous infusion at 1,000 mg/m2 at a rate of approximately 10 mg/m2/minute, on days 5 and 12 of every cycle.

Protocol documents:
Clinical trial NCT02319642
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis TNFα antagonist Certolizumab pegol Chinese patients Open-label
Sponsor: UCB Pharma SA
Start date: 2014-11-01; Completion date: 2016-12-01
Enrollment: 347 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will continue to evaluate the safety \& efficacy of Certolizumab Pegol (CZP) for 6 months in Chinese subjects with active Rheumatoid Arthritis who participated in RA0044.

Detailed description:
This study (RA0078) will continue to assess the safety, tolerability, and efficacy of Certolizumab Pegol (CZP) for 6 months as additional medication to methotrexate (MTX) with or without folic acid in Chinese subjects with active Rheumatoid Arthritis (RA) who participated in the main feeder study, RA0044. All subjects will continue to receive their established treatment with MTX with or without folic acid. The dose of MTX may be decreased by the Investigator due to toxicity, but should not be discontinued completely. Concomitant nonsteroidal anti-inflammatory drugs and oral corticosteroids will be permitted. For each subject, the study duration will last a maximum of approximately 32 weeks.

Arms: arm 1: 1. Those subjects from either treatment group in RA0044 (NCT02151851) who fail to achieve an ACR20 response in RA0044 (NCT02151851) at Week 12, which is confirmed at Week 14. These subjects are withdrawn from RA0044 (NCT02151851) at Week 16 of that study, and that assessment will also be the Entry assessment for this Extension study. In this OLE study, these subjects will receive CZP 400 mg sc at Weeks 0, 2, and 4 followed by CZP 200 mg sc Q2W.
2. Subjects from either treatment group in RA0044 (NCT02151851) who completed RA0044 (NCT02151851) through Week 24. The Week 24 assessment in RA0044 (NCT02151851) will also be the Entry assessment for this Extension study. In this OLE study, these subjects will receive CZP 200 mg sc Q2W.
Interventions: intervention 1: Certolizumab Pegol
Intervention descriptions: intervention 1: Active Substance: Certolizumab Pegol Pharmaceutical form: Prefilled syringes Concentration: 200 mg/ ml Route of Administration: Subcutaneous injection

Protocol documents:
Clinical trial NCT02344628
Conditions: Yaws
Sponsor: London School of Hygiene and Tropical Medicine
Start date: 2015-06-01; Completion date: 2016-12-01
Enrollment: 583 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will be a single blinded, randomized, controlled open label non-inferiority phase III, trial with two parallel groups, conducted in Ghana and Papua New Guinea (PNG). The ultimate goal is to establish if a 20mg/kg dose of azithromycin is as effective as a 30mg/kg dose in the treatment of yaws. Approximately 600 clinically and serologically diagnosed yaws patients will be included in the study. Patients will be randomized to receive treatment with the two antibiotic regimens as follow: (i) Regimen I (AZT20): Single oral dose of 20 mg/kg azithromycin (ii) Regimen II (AZT30): Single oral dose of 30 mg/kg azithromycin. The follow-up period of patients will be 6 months. Assessments before, during and after the antibiotic treatment will include full medical history, clinical assessment of the lesion and, laboratory investigations. The primary efficacy parameters are healing of the lesion at 4 weeks and a four-fold decline in RPR titre at 6 months after start of treatment.

Detailed description:

Arms: arm 1: Single dose of azithromycin at a dose of 30mg/kg - max 2 Grams arm 2: Single dose of azithromycin at a dose of 20mg/kg - max 1 Grams
Interventions: intervention 1: Azithromycin
Intervention descriptions: intervention 1: Comparison of two different dosing strategies for the treatment of yaws

Protocol documents:
Clinical trial NCT02358473
Conditions: Non-Small Cell Lung Cancer
Keywords: Nonsmall Cell Lung Cancer NSCLC Non-Small-Cell Lung Carcinoma Carcinoma, Non-Small Cell Lung KW-0761 Mogamulizumab
Sponsor: Kyowa Kirin, Inc.
Start date: 2015-01-01; Completion date: 2016-12-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety of mogamulizumab in combination with docetaxel in adult subjects with previously treated locally advanced or metastatic non-small cell lung cancer.

Detailed description:

Arms: arm 1: Mogamulizumab will be given as monotherapy in a 4-week run-in period. Subjects will then receive up to 6 cycles of mogamulizumab in combination with docetaxel at appropriate intervals.

Subjects may then continue to receive mogamulizumab, at the same dose administered in Cycle 1, once every 3 weeks as monotherapy.
Interventions: intervention 1: mogamulizumab intervention 2: Docetaxel
Intervention descriptions: intervention 1: Mogamulizumab will be administered by IV infusion. intervention 2: Docetaxel will be administered by IV infusion.

Protocol documents:
Clinical trial NCT02363439
Conditions: Waldenstrom's Macroglobulinemia
Sponsor: Idera Pharmaceuticals, Inc.
Start date: 2014-11-01; Completion date: 2016-12-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
An extension study for patients who complete 24 weeks of IMO-8400 on study 8400-401.

Detailed description:
Patients who had no evidence of disease progression or toxicity while participating in study 8400-401 (NCT02092909) will continue to receive IMO-8400 until disease progression, adverse event or the investigator deems the goals of extended treatment with IMO-8400 have been met.

Arms: arm 1: Subcutaneous injection of IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly per Protocol 8400-401
Interventions: intervention 1: IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly
Intervention descriptions: intervention 1: IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg twice weekly as defined per Protocol 8400-401

Protocol documents:
Clinical trial NCT02371252
Conditions: Osteoporosis
Keywords: Osteoporosis Bisphosphonates Alendronate Bone mineral density Bone markers
Sponsor: Mahidol University
Start date: 2014-04-01; Completion date: 2016-12-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Osteoporosis is a common disease defined as a decrease in bone mass and strength which increases risk of fragility fractures. This disorder may affecting health in many adults which causing disability, morbidity, and mortality. Current first-line medical therapy is bisphosphonates which alendronate is one of the most widely used. However, expenditure on medicines is one of the major problem of inadequate access to treatment.

The investigators hypothesized that generic alendronate will have the same clinical efficacy as the brand formulation. Therefore, the result of this study is extremely crucial. If adequate efficacy of generic alendronate could be established and if it affords the same safety profile as those of brand alendronate, the use of generic alendronate could then be recommended.

Detailed description:
Osteoporosis is a common disease which estimated that over 200 million people worldwide are suffered. The prevalence is continuing to escalate with the increasingly elderly population. The risk of fragility fractures in elder over age 50 is approximately 50% in women and 20% in men.

Current first-line medical therapy is bisphosphonates which alendronate is one of the most widely used. However, expenditure on medicines is one of the major problem of inadequate access to treatment. Generally, insurances and health care providers prefer physicians to prescribe generic instead of brand drug, due to its lower costs. However, clinical information on bone mineral density (BMD), fracture reduction and side effects with new generic alendronate is limited.

The objective of this study is to evaluate the efficacy and safety of a new generic alendronate (Bonmax®) comparing to brand alendronate (Fosamax®). The efficacy of generic alendronate will be determined by measuring the percent changes of bone mineral densities at lumbar spine and total hip after 1 year of treatment and then comparing to those changes in the brand alendronate group.

Arms: arm 1: The patients will be given the brand alendronate (Fosamax®) (70 mg) 1 tablet once a week orally for 1 year after enrollment. In addition, calcium and vitamin D supplementation will be given to all patients. arm 2: The patients will be given the generic alendronate (Bonmax®) (70 mg) 1 tablet once a week orally for 1 year after enrollment. In addition, calcium and vitamin D supplementation will be given to all patients.
Interventions: intervention 1: Generic alendronate
Intervention descriptions: intervention 1: The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment.

Protocol documents:
Clinical trial NCT02431273
Conditions: Human Immunodeficiency Virus (HIV) Prophylaxis
Keywords: TDF FTC MVC TDF-FTC TDF-FTC-MVC IVR ARV
Sponsor: Auritec Pharmaceuticals
Start date: 2015-06-01; Completion date: 2016-12-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the hypothesis that intravaginal rings (IVRs) can safely and in a sustained fashion, deliver the antiretroviral (ARV) drugs - tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and maraviroc (MVC), in healthy women when used in the following drug combinations: 1) TDF ("Single" IVR); 2) TDF-FTC ("Dual" IVR) and; 3) TDF-FTC-MVC ("Triple" IVR).

TDF = tenofovir disoproxil fumarate; FTC = emtrcitabine; MVC = maraviroc

Detailed description:
The broad long term goal of this project is to empower women to protect themselves from HIV through woman-controlled sustained local delivery of ARTs via intravaginal rings. The short-term general investigational plan is to evaluate IVRs releasing TDF, TDF-FTC and TDF-FTC-MVC in healthy women for up to 7 days in an open-label study to determine safety and drug concentrations in plasma and cervicovaginal lavage and secretions. Additional exploratory studies will be considered and planned based in part on the results obtained in this study. The long-term investigational plan is to evaluate the safety and efficacy of sustained release TDF, TDF-FTC and TDF-FTC-MVC for their ability to decrease HIV transmission to vulnerable women.

Arms: arm 1: All subjects will be asked to wear "Single" (TDF) IVRs for 7 days. arm 2: If the TDF IVR is determined as safe, study participants will be asked to replace it with "Dual" (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR. arm 3: If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with "Triple" (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR.
Interventions: intervention 1: TDF IVR intervention 2: TDF-FTC IVR intervention 3: TDF-FTC-MVC IVR
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02437344
Conditions: Opioid Dependence
Sponsor: New York State Psychiatric Institute
Start date: 2015-01-01; Completion date: 2016-12-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Opioid dependence is a substantial problem associated with significant morbidity and mortality. Extended-release naltrexone has been found effective at reducing opioid use and maintaining abstinence, but its use has been limited by the difficulties encountered with treatment initiation, which involves detoxification from opioids and oral naltrexone titration. Improving the likelihood of a successful transition to naltrexone is therefore an important public health goal.

N-methyl-D-aspartate receptor (NMDA) antagonism has been found to alleviate the signs and symptoms of withdrawal from opioids, as well as to address adaptations associated with chronic opioid use, such as opioid-induced hyperalgesia (increased pain sensitivity). These benefits may persist for at least 72 hours after a single dose. NMDA antagonism may therefore facilitate a rapid transition to naltrexone by reducing discomfort, improving motivation, and ameliorating adaptations associated with drug dependence, such as craving and arousal.

The purpose of this trial is to assess the feasibility of NMDA antagonist-assisted naltrexone initiation in opioid dependent individuals. After administration of extended-release naltrexone, participants will be followed for 4 weeks, and transitioned to appropriate care subsequently (oral naltrexone, extended-release naltrexone).

Detailed description:

Arms: arm 1: CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing
Interventions: intervention 1: CI-581aa intervention 2: Naltrexone titration and XR-NTX initiation
Intervention descriptions: intervention 1: 92 minute infusion of CI-581aa intervention 2: participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX

Protocol documents:
Clinical trial NCT02452528
Conditions: Chronic Hepatitis B
Keywords: Hepatitis B Virus Chronic Hepatitis B HBV
Sponsor: Arrowhead Pharmaceuticals
Start date: 2015-08-01; Completion date: 2016-12-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Participants with chronic HBV infection will receive multiple doses of ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.

Detailed description:

Arms: arm 1: Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.

Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug. arm 2: Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.

Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo.
Interventions: intervention 1: ARC-520 intervention 2: Placebo intervention 3: Entecavir intervention 4: Tenofovir intervention 5: diphenhydramine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: 0.5 or 1.0 mg/day orally intervention 4: 300 mg/day orally intervention 5: 50 mg orally as pretreatment antihistamine

Protocol documents:
Clinical trial NCT02462070
Conditions: Plaque Psoriasis
Sponsor: Bausch Health Americas, Inc.
Start date: 2015-08-11; Completion date: 2016-12-01
Enrollment: 203 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to evaluate the safety and efficacy of a topical lotion.

Detailed description:
The objective of the study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult subjects with moderate to severe plaque psoriasis.

Arms: arm 1: Lotion arm 2: Vehicle Lotion
Interventions: intervention 1: IDP-118 Lotion intervention 2: IDP-118 Vehicle Lotion
Intervention descriptions: intervention 1: Lotion intervention 2: Lotion

Protocol documents:
Clinical trial NCT02475629
Conditions: HIV
Sponsor: TaiMed Biologics Inc.
Start date: 2015-08-01; Completion date: 2016-12-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This Phase 3, single arm, multicenter study will evaluate the safety and effectiveness of ibalizumab in treatment-experienced patients infected with multi-drug resistant HIV-1.

Detailed description:
This Phase 3, single arm, multicenter study will evaluate the safety and effectiveness of ibalizumab in treatment-experienced patients infected with multi-drug resistant HIV-1. Patients must have been treated with HAART for at least 6 months and be failing or have recently failed (i.e., in the last 8 weeks) therapy to determine baseline viral load.

Days 0-6 of the study will be a "control period." During Days 0 through 6 patients will be monitored on current failing therapy (or no therapy, if the patient has failed and discontinued treatment within the 8 weeks preceding Screening).

Days 7-13 of the study will be an "essential monotherapy period." During Days 7 through 13 patients will continue on current failing therapy and receive one 2000 mg dose (loading dose) of ibalizumab on Day 7. Day 7 is Baseline for the treatment period (Day 7-Week 25).

Day 14-Week 25 of the study will be the "maintenance period." On Day 14 (primary endpoint), the OBR will be initiated and must include at least one agent to which the patient's virus is susceptible. Beginning at Day 21, 800 mg of ibalizumab will be administered every 2 weeks through Week 23.

End of Study evaluations will be performed at Week 25, and a follow-up visit will be conducted at Week 29.

Arms: arm 1: 2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.
Interventions: intervention 1: ibalizumab intervention 2: Optimized Background Regimen (OBR)
Intervention descriptions: intervention 1: 2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks intervention 2: All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Protocol documents: