ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02662608
Conditions: Adenoid Cystic Carcinoma
Keywords: Brontictuzumab
Sponsor: M.D. Anderson Cancer Center
Start date: 2015-12-29; Completion date: 2016-03-06
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this study is to start treatment with the NOTCH1 inhibitor brontictuzumab in an attempt to control tumors and prolong survival. The therapy involves participant being given the drug brontictuzumab to treat adenoid cystic carcinoma (ACC) with NOTCH 1 mutations. This is considered an investigational treatment.

Detailed description:
Treatment:

Participant will receive brontictuzumab by vein over 30 minutes one time every 3 weeks.

Clinic Visits:

On Day 1 of Cycle 1 and then every 3 weeks from then on:

* Participant will have a physical exam
* Blood (about 3 teaspoons) will be drawn for routine tests.

Every 6 weeks, participant will have an MRI and CT scan to check the status of the disease.

Length of Treatment:

Participant may continue taking brontictuzumab for as long as the doctor thinks it is in their best interest. Participant will no longer be able to take the drug if the disease gets worse, they develop another illness that prevents receiving more treatment, or if intolerable side effects occur.

Brontictuzumab is not FDA approved or commercially available. It is currently being used for research purposes only.

Arms: arm 1: 1.5 mg/Kg of Brontictuzumab single agent intravenously every three weeks.
Interventions: intervention 1: Brontictuzumab
Intervention descriptions: intervention 1: 1.5 mg/Kg intravenously every three weeks.

Protocol documents:
Clinical trial NCT02461771
Conditions: Neovascular Age-Related Macular Degeneration
Keywords: AMD Wet AMD Neovascular AMD
Sponsor: Apellis Pharmaceuticals, Inc.
Start date: 2015-01-28; Completion date: 2016-03-08
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The objective of this study is to provide initial safety, tolerability and pharmacokinetics information of intravitreal administration of pegcetacoplan in order to support further development into larger Phase II studies for treatment of patients with AMD.

Detailed description:

Arms: arm 1: 4 mg of pegcetacoplan 100 μL IVT injection arm 2: 10 mg of pegcetacoplan 100 μL IVT injection arm 3: 20 mg of pegcetacoplan 100 μL IVT injection
Interventions: intervention 1: Pegcetacoplan
Intervention descriptions: intervention 1: On treatment day, subjects will be administered a single 100 μL IVT injection of pegcetacoplan at the dose corresponding to their treatment assignment.

Protocol documents:
Clinical trial NCT01764841
Conditions: Bronchiectasis
Keywords: Ciprofloxacin Dry Powder for Inhalation Exacerbation Bronchiectasis
Sponsor: Bayer
Start date: 2013-05-02; Completion date: 2016-03-09
Enrollment: 416 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.

Detailed description:
Number of participants with Adverse events will be covered in Adverse Events section.

The statistical analysis tests for the efficacy variables will be performed hierarchically. The comparisons ciprofloxacin DPI vs. pooled placebo (according to statistical analysis plan defined for FDA registration) will be performed in parallel for the regimen 28 days on/off and 14 days on/off.

Arms: arm 1: Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles). arm 2: Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles). arm 3: Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles). arm 4: Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
Interventions: intervention 1: Ciprofloxacin DPI (BAYQ3939) intervention 2: Placebo
Intervention descriptions: intervention 1: Participants received 32.5 mg ciprofloxacin hydrated (corresponding to 50 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device. intervention 2: Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device.

Protocol documents:
Clinical trial NCT02274766
Conditions: Dyskinesia Levodopa-Induced Dyskinesia (LID) Parkinson's Disease (PD)
Keywords: Levodopa-Induced Dyskinesia LID Parkinsonism Parkinson's Disease
Sponsor: Adamas Pharmaceuticals, Inc.
Start date: 2014-10-01; Completion date: 2016-03-10
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance.

In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.

Detailed description:

Arms: arm 1: ADS-5102 (amantadine HCl extended release) arm 2: Placebo
Interventions: intervention 1: ADS-5102 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral capsules to be administered once nightly at bedtime, for 13 weeks. intervention 2: Oral capsules to be administered once nightly at bedtime, for 13 weeks.

Protocol documents:
Clinical trial NCT02516306
Conditions: Presbyopia
Keywords: Presbyopia Vision UNR844
Sponsor: Encore Vision, Inc.
Start date: 2015-09-16; Completion date: 2016-03-10
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether EV06 Ophthalmic Solution is safe and effective in improving distance corrected near vision in people who have presbyopia.

Detailed description:
Study subjects who were eligible for enrollment and had provided written informed consent were randomized in a 2:1 ratio to use of either EV06 Ophthalmic Solution or Placebo Ophthalmic Solution. For the first 7 days of study product administration (Period 1: Days 1-7), subjects applied 1 drop of their assigned study product to one eye twice per day. For the next 84 days (Period 2: Days 8 - 91), if there were no unanticipated and no significant adverse events observed in the treated eye, subjects applied 1 drop of their assigned study product to both eyes twice per day.

Arms: arm 1: EV06 Ophthalmic Solution: Day 1 - 7 one drop twice per day in one eye; Day 8 - 91 one drop twice per day in both eyes. arm 2: Placebo Ophthalmic Solution (EV06 vehicle): Day 1 - 7 one drop twice per day in one eye; Day 8 - 91 one drop twice per day in both eyes.
Interventions: intervention 1: EV06 Ophthalmic Solution intervention 2: Placebo Ophthalmic Solution
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00600886
Conditions: Acromegaly
Keywords: Acromegaly, adult, growth hormone, insulin-like growth factor I, somatostatin analogue
Sponsor: Novartis Pharmaceuticals
Start date: 2008-02-11; Completion date: 2016-03-11
Enrollment: 358 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment.

The objective of this study was to compare the proportion of patients with a reduction of mean GH level to \<2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months.

Following one year of treatment patients could proceed into the study extension.

Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.

Detailed description:

Arms: arm 1: Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 20 or 60 mg, respectively. Patients who responded to Pasireotide LAR (i.e. the randomized treatment) at the end of the core (Month 12), continued Pasireotide LAR treatment in the extension. Patients who did not respond to Pasireotide LAR at the end of the core (Month 12) were allowed to switch to receive Octreotide LAR in the extension. arm 2: Patients in this arm received Octreotide LAR 20 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Dose could be down- or up-titrated to 10 or 30 mg, respectively. Patients who responded to Octreotide LAR (i.e. the randomized treatment) at the end of the core (Month 12) continued Octreotide LAR treatment in the extension (up to 2 years of treatment). Patients who did not respond to Octreotide LAR at the end of the core (Month 12) were allowed to switch to receive Pasireotide LAR in the extension.
Interventions: intervention 1: Pasireotide intervention 2: Octreotide
Intervention descriptions: intervention 1: Pasireotide LAR - intramuscular (i.m.) depot injection given once every 28 days. intervention 2: Octreotide LAR - i.m. depot injection given once every 28 days.

Protocol documents:
Clinical trial NCT01618656
Conditions: Cannabis Dependence
Sponsor: Yale University
Start date: 2012-09-12; Completion date: 2016-03-11
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Cannabis dependence is associated with changes in the brain's cannabinoid system. When cannabis dependent individuals try to quit using cannabis, some of them experience problems that make it difficult for them to achieve and maintain abstinence. Therefore, reducing the problems related to quitting cannabis may facilitate abstinence. One way to do this is by harnessing the brain's capacity to make its own cannabis-like substances - endocannabinoids. One of the main endocannabinoids is anandamide. The study is based on the hypothesis that the problems related to quitting cannabis use will be reduced by increasing the brain levels of anandamide. Furthermore, by reducing the problems related to quitting cannabis, people will be less likely to relapse. Brain anandamide levels will be increased by blocking the breakdown of anandamide using a fatty acid amide hydrolase inhibitor (FAAH-I). The effects of a novel FAAH-I cannabis withdrawal and relapse in cannabis dependent subjects will be studied in a double-blind, randomized, controlled, proof-of-concept study. Cannabis-dependent subjects will receive placebo or the FAAH-inhibitor PF-04457845 in a 2:1 randomization. The trial consists of a 1 week inpatient stay to achieve abstinence, a 3 week outpatient treatment phase. Cannabis withdrawal will be measured during the inpatient phase. Cannabis use and urinary THC-COOH levels will be measured during the entire study. The treatment phase will be followed by a safety follow up phase of 8 weeks.

Detailed description:

Arms: arm 1: 2/3 of subjects will be randomized to fatty acid amide hydrolase (FAAH) inhibitor 4mg arm 2: 1/3 of subjects will be randomized to placebo
Interventions: intervention 1: PF-04457845 intervention 2: Placebo
Intervention descriptions: intervention 1: Study medication will be administered at 4mg by mouth daily for four weeks. intervention 2: Sugar pill

Protocol documents:
Clinical trial NCT02576639
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease, Amyloid Beta, cerebrospinal fluid, beta secretase
Sponsor: Novartis Pharmaceuticals
Start date: 2015-08-10; Completion date: 2016-03-11
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in subsequent efficacy studies.

Detailed description:

Arms: arm 1: Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks. arm 2: CNP520 2 mg was taken qd orally for 13 weeks. arm 3: CNP520 10 mg was taken qd orally for 13 weeks. arm 4: CNP520 35 mg was taken qd orally for 13 weeks. arm 5: CNP520 85 mg was taken qd orally for 13 weeks.
Interventions: intervention 1: CNP520 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Matching placebo to CNP520 was supplied in capsules.

Protocol documents:
Clinical trial NCT02634073
Conditions: Infection, Human Immunodeficiency Virus
Keywords: Lamivudine Safety Sorbitol Pharmacokinetics
Sponsor: ViiV Healthcare
Start date: 2016-01-01; Completion date: 2016-03-11
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Lamivudine (3TC) is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and children. Documented literature elucidates that simultaneous administration of multiple sorbitol-containing products could increase the potential for a significant interaction and may contribute to the lower 3TC exposures.

In this study several sorbitol doses (3.2 gram (g), 10.2 g, and 13.4 g solutions) will be administered with lamivudine to investigate dose dependency and mimic the situation where multiple sorbitol-containing antiretroviral medications may be co-administered with lamivudine. It will be open label, randomized, 4-way crossover (by William's design method) design at a single centre. Randomized participants will receive a single dose of each of four treatments after wash out period of minimum 7 days.

Detailed description:

Arms: arm 1: Participant will receive single dose of Lamivudine 300 mg (30 ml of 10 mg/ml Oral Solution) after overnight fasting. Treatment period will be separated by at least 7 day wash out period. arm 2: Participant will receive single dose of Lamivudine 300 mg (30 ml of 10 mg/ml Oral Solution) + oral solution of Sorbitol 3.2 g after overnight fasting. Treatment period will be separated by at least 7 day wash out period. arm 3: Participant will receive single dose of Lamivudine 300 mg (30 ml of 10 mg/ml Oral Solution) + oral solution of Sorbitol 10.2 g after overnight fasting. Treatment period will be separated by at least 7 day wash out period arm 4: Participant will receive single dose of Lamivudine 300 mg (30 ml of 10 mg/ml Oral Solution) + oral solution of Sorbitol 13.4 g after overnight fasting. Treatment period will be separated by at least 7 day wash out period
Interventions: intervention 1: Lamivudine intervention 2: Sorbitol
Intervention descriptions: intervention 1: It is a clear, colorless to pale yellow solution with the odour of fruit. It will be provided in a 240 mL bottle with the strength of 10 mg/mL Lamivudine 300 mg (30 mL of solution) will be administered orally to the participants intervention 2: It is a clear, colorless, odourless solution. It will be available in 3 dosage levels viz;. 3.2 g (low dose), 10.2 g (medium dose) and 13.4 g (high dose) sorbitol total dose.

Protocol documents:
Clinical trial NCT01199146
Conditions: Prostate Cancer
Keywords: Abiraterone acetate
Sponsor: University of California, San Francisco
Start date: 2010-09-10; Completion date: 2016-03-14
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II, open label, single center study to evaluate the efficacy of abiraterone acetate (CB7630) administered to patients with castrate resistant prostate cancer who have experienced disease progression on ketoconazole.

It is hypothesized that abiraterone will be active in patients who have experienced disease progression on ketoconazole

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Abiraterone acetate
Intervention descriptions: intervention 1: Abiraterone acetate 1000 mg by mouth per day

Protocol documents:
Clinical trial NCT01976312
Conditions: Central Retinal Vein Occlusion
Keywords: CRVO, macular edema, vision impairment, retinal vein occlusion, ranibizumab
Sponsor: Novartis Pharmaceuticals
Start date: 2013-11-12; Completion date: 2016-03-14
Enrollment: 252 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to CRVO

Detailed description:

Arms: arm 1: PRN intravitreal injection arm 2: As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
Interventions: intervention 1: Sham injection intervention 2: Ranibizumab 0.5 mg
Intervention descriptions: intervention 1: Sham injections referred to the imitation of an intravitreal injection using an injection syringe without needle. intervention 2: Ranibizumab solution for injection was supplied in vials. Each vial contained ranibizumab concentration of 10mg/mL labeled as 0.5 mg/0.5 mL, corresponding to a 0.5 mg dose level. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial for single use only

Protocol documents:
Clinical trial NCT02316171
Conditions: Non-muscle Invasive Bladder Cancer
Keywords: Coxsackievirus A21 bladder cancer CVA21 CAVATAK
Sponsor: Viralytics
Start date: 2015-01-16; Completion date: 2016-03-14
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The study consisted of 2 sequential parts. Part A assessed the safety and tolerability of CAVATAK administered via intravesical instillation in patients with non-muscle invasive bladder cancer scheduled to undergo TUR. Part B assessed the safety and tolerability of CAVATAK administered in sequential combination with low dose Mitomycin C in the same patient population.

Detailed description:
This was a Phase I, two-part, open-label, dose-escalation study designed to evaluate CVA21 alone and in sequential combination with low-dose mitomycin C in patients with non-muscle invasive bladder cancer (NMIBC) who were candidates for and were planning to undergo TUR for treatment of their disease. This gave a relatively homogeneous study population and facilitated collection of resected tumour tissue for histological, pharmacodynamics (PD) and pharmacokinetic (PK) analyses.

Arms: arm 1: CVA21 was administered by intravesical instillation at one of three (3) ascending dose levels or schedules. arm 2: Mitomycin C (MMC) was administered at 10 mg by intravesical instillation on Day 1. Four hours after instillation of MMC, CVA21 was administered by intravesical instillation of one of 2 ascending dose levels or schedules. Subjects received a second instillation of CVA21 alone on Day 2 without pretreatment with MMC.
Interventions: intervention 1: CVA21 intervention 2: Mitomycin C
Intervention descriptions: intervention 1: CAVATAK is a purified preparation of CVA21 intervention 2: Chemotherapy

Protocol documents:
Clinical trial NCT01720446
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2013-02-21; Completion date: 2016-03-15
Enrollment: 3297 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: semaglutide intervention 2: semaglutide intervention 3: placebo
Intervention descriptions: intervention 1: Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin) intervention 2: Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg followed by 0.5 mg dose escalation as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin) intervention 3: Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).

Protocol documents: