ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01769391
Conditions: Squamous Non Small Cell Lung Cancer
Keywords: NSCLC
Sponsor: Eli Lilly and Company
Start date: 2013-01-01; Completion date: 2017-07-01
Enrollment: 167 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.

Detailed description:

Arms: arm 1: Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.

Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.

Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.

The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. Necitumumab may continue until Progressive Disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent. arm 2: Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. After completion of chemotherapy, participants will be followed until radiographic documentation of PD.
Interventions: intervention 1: Necitumumab intervention 2: Paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered IV intervention 3: Administered IV

Protocol documents:
Clinical trial NCT02033369
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder MDD depression pramipexole
Sponsor: New York State Psychiatric Institute
Start date: 2014-02-01; Completion date: 2017-07-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to determine whether ventral striatal dopamine release is a mechanism of reward motivation in major depression, whether dopamine release is low in depression, and whether DA release and reward motivation predict response to dopamine-targeted treatment with pramipexole.

Detailed description:
Better understanding of the basic neurobiology of mood dysfunction appears necessary to enable further progress in the treatment of depression. Reward motivation (and the closely related construct of "reward learning") is a core neurobehavioral domain.(1,2) In major depressive disorder (MDD), low reward motivation is a key aspect of anhedonia, a cardinal symptom of MDD, and is related to resistance to treatment.(2,3) Although much has been learned about reward motivation's neurobiology and relevance to psychopathology, important gaps in our knowledge have impeded the application of basic science findings to improving treatment of MDD. Reward motivation in healthy subjects involves ventrostriatal (VST) dopamine (DA)(4,5), and reduced reward motivation is linked to MDD and anhedonia.(3,6) These data suggest that VST DA dysfunction might be present in MDD and manifested clinically by anhedonia. While DA neuroreceptor imaging studies have failed to verify this, they have been methodologically compromised. Limitations include imaging methods with poor resolution of functional striatal subregions, MDD samples heterogeneous for antidepressant use, and use of self-report measures of anhedonia, rather than objective behavioral testing of the specific domain of reward motivation. This will be the first study of both VST DA release (by PET imaging) and reward motivation, and will include patients with MDD and healthy volunteers. Reward motivation will be captured and operationalized as reward learning in a probabilistic reward task (prior to imaging). This will clarify if VST DA dysfunction is linked to impaired motivation in MDD. To test clinical implications in MDD patients, we will assess the relationship of VST DA release, reward motivation, and anhedonia to outcome of subsequent open label treatment with the DA D2 receptor agonist pramipexole.

Arms: arm 1: Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg. arm 2: Healthy volunteers were matched to MDD group subjects by age, gender, and ethnicity, and will have no lifetime psychiatric disorders.
Interventions: intervention 1: Pramipexole
Intervention descriptions: intervention 1: Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day.

Protocol documents:
Clinical trial NCT02630992
Conditions: Acute Otitis Media
Keywords: ear infections antibiotics antibiotic resistance pediatrics infants children amoxicillin-clavulanate
Sponsor: Nader Shaikh
Start date: 2015-12-01; Completion date: 2017-07-01
Enrollment: 112 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided doses for 10 days. Investigators will focus on the proportion of subjects who develop protocol-defined diarrhea and proportion who develop diaper dermatitis that occasions the prescription of antifungal medication.

Detailed description:
Amoxicillin-clavulanate potassium has been shown to be efficacious in eradicating causative pathogens in acute otitis media (AOM) with resulting high clinical cure rates at end-of-treatment (85%). However, relatively high rates (\~25%) of clinically significant diarrhea have been reported, the occurrence of which has been directly related to the clavulanate potassium component of the drug combination. A reduced concentration of clavulanate potassium in the drug formulation would be expected to have an improved safety profile regarding the occurrence of diarrhea. This study will examine whether the concentration of the clavulanate potassium component of amoxicillin-clavulanate potassium could be reduced in the treatment of children 6 months through 23 months of age diagnosed with AOM using stringent criteria. A total of 75 participants (n=75) with AOM will receive amoxicillin-clavulanate potassium (600 mg/21.5 mg/5 mL; 28:1) administered at 90/3.2 mg/kg/day (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided doses for 10 days.

The primary outcome measure will be rates of clinically significant diarrhea and diaper dermatitis. These rates will be compared with the rate observed in our previous studies of AOM in children who received amoxicillin-clavulanate potassium (600 mg/42.9 mg/5 mL; 14:1) administered at 90/6.4 mg/kg/day in two divided doses for 10 days.

A subset of this group will have pharmacokinetic studies performed. Each participant that agrees will have a single blood draw (n=50). Investigators will analyze amoxicillin and clavulanate potassium in the blood samples using validated methods.

Arms: arm 1: amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)
Interventions: intervention 1: Amoxicillin-Clavulanate potassium
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02673138
Conditions: Type 1 Diabetes
Sponsor: Yale University
Start date: 2016-01-01; Completion date: 2017-07-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will be an open-label, cross-over study as subjects will be studied under both study conditions - suspension of subcutaneous insulin infusion via pump during treatment with insulin alone (control) vs. suspension of subcutaneous insulin via pump during treatment with insulin and canagliflozin.

Detailed description:
The study will consist of 4 visits: an enrollment/screening visit, a control visit with pump suspension prior to treatment with canagliflozin, a visit with pump suspension while on canagliflozin and an end of study visit. Each of the pump suspension visits will be approximately 20-hour overnight admissions to the Hospital Research Unit (HRU).

Arms: arm 1: Subjects will undergo basal interruption without canagliflozin during an overnight stay on the research unit arm 2: Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit
Interventions: intervention 1: canagliflozin intervention 2: basal interruption without canagliflozin
Intervention descriptions: intervention 1: basal interruption with canagliflozin intervention 2: basal interruption

Protocol documents:
Clinical trial NCT02806869
Conditions: Human Gastrointestinal Physiology Data
Sponsor: University of Michigan
Start date: 2015-01-01; Completion date: 2017-07-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In vivo drug dissolution in the gastrointestinal (GI) tract is largely unmeasured. The purpose of this clinical study was to evaluate the in vivo drug dissolution and systemic absorption of the BCS Class IIa drug ibuprofen under fed and fasted conditions by direct sampling of stomach and small intestinal luminal content. Expanding current knowledge of drug dissolution in vivo will help to establish physiologically relevant in vitro models predictive of drug dissolution.

Detailed description:
This is an in vivo study designed to acquire human gastrointestinal (GI) physiology data from healthy subjects under fasting and fed conditions which are necessary for mechanistic absorption model development. Each subject will be asked to complete two GI tube insertion procedures. Subjects will complete this study twice under the same conditions of the GI tract, either fasting state or fed state, in order to provide intra-subject variability. A minimum of 7 days will separate each GI tube insertion procedure. The objectives of this study are, as follows: Objective #1: To acquire human GI physiology data including GI motility, pH of GI fluids, and GI fluid volume under fasting and fed conditions; Objective #2: To measure drug concentration and calculate drug dissolution in the GI tract in vivo under fasting and fed conditions; Objective #3: To monitor plasma drug concentration and evaluate pharmacokinetics of administered drug during GI tube insertion studies under fasting and fed conditions. These in vivo results will be used to validate in vitro dissolution methods and to support computational and mathematical modeling efforts, in order to develop an oral drug product optimization process that may be applied to future drugs to maximize oral drug safety and efficacy.

Arms: arm 1: 1. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red
2. Washout period of at least 7 days
3. Single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red arm 2: 1. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red
2. Washout period of at least 7 days
3. Pulmocare, two 8.0 oz (236.6 mL) cans, followed by single dose of ibuprofen (800 mg tablet) administered with 250 mL of water containing phenol red
Interventions: intervention 1: Single dose of ibuprofen (800 mg tablet) intervention 2: Pulmocare, two 8.0 oz (236.6 mL) cans
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01707992
Conditions: Multiple Sclerosis
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2013-02-20; Completion date: 2017-07-04
Enrollment: 2199 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod in participants with RRMS. The study has 2 periods: Period 1, the double-blind, placebo-controlled period (up to 24 months) and Period 2, the active treatment period (24 months).

Detailed description:

Arms: arm 1: Participants will receive 2 capsules of placebo (matching to laquinimod 0.6 milligrams \[mg\]) once daily orally for up to 24 months. arm 2: Participants will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months. arm 3: Participants will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months. arm 4: Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months. arm 5: Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months. arm 6: Participants who were discontinued from treatment with laquinimod 1.2 mg during the placebo-controlled phase due to sponsor decision after 01 January 2016 will continue the active-treatment phase off drug for 24 months.
Interventions: intervention 1: Laquinimod intervention 2: Placebo
Intervention descriptions: intervention 1: Laquinimod will be administered as per the dose and schedule specified in the respective arms. intervention 2: Placebo matching to laquinimod will be administered as per the schedule specified in the respective arms.

Protocol documents:
Clinical trial NCT00082888
Conditions: Anaplastic Large Cell Lymphoma Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma Nodal Marginal Zone Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Adult T-Cell Leukemia/Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Non-Hodgkin Lymphoma Recurrent Small Lymphocytic Lymphoma Splenic Marginal Zone Lymphoma
Sponsor: National Cancer Institute (NCI)
Start date: 2004-03-24; Completion date: 2017-07-05
Enrollment: 93 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well tipifarnib works in treating patients with relapsed or refractory non-Hodgkin's lymphoma. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Tipifarnib may be an effective treatment for non-Hodgkin's lymphoma.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess tumor response to R115777 (tipifarnib) in patients with relapsed aggressive non-Hodgkin's lymphoma. (Permanently closed to accrual 6/28/06) II. To assess tumor response to R115777 in patients with relapsed indolent non-Hodgkin's lymphoma. (Permanently closed to accrual 9/26/07) III. To assess tumor response to R115777 in patients with uncommon non-Hodgkin's lymphomas.

IV. To evaluate toxicity associated with this regimen in patients with relapsed non-Hodgkin's lymphoma.

SECONDARY OBJECTIVES:

I. To evaluate known and unknown molecular markers that may predict for response to R115777 in lymphoma tissue.

OUTLINE:

Patients receive tipifarnib orally (PO) twice daily (BID) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years.

Arms: arm 1: Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Tipifarnib
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO

Protocol documents:
Clinical trial NCT00547105
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer stage IIIA non-small cell lung cancer
Sponsor: University of Texas Southwestern Medical Center
Start date: 2007-06-25; Completion date: 2017-07-06
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving erlotinib together with stereotactic body radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with stereotactic body radiation therapy works in treating patients with locally advanced or metastatic non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* To evaluate the effect of erlotinib and stereotactic body radiotherapy on 6-month progression-free survival of patients with locally advanced or metastatic non-small cell lung cancer.

Secondary

* To describe the actuarial rate of in-field local control and out-of-field disease progression in patients treated with this regimen.
* To evaluate the safety of this regimen in these patients.
* To evaluate overall survival of patients treated with this regimen.
* To evaluate the duration of erlotinib usage and time to initiation of third-line systemic therapy (chemotherapy or biologic agent) in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity. Beginning 1-4 weeks after the initiation of erlotinib hydrochloride, patients undergo stereotactic body radiotherapy.

After completion of study treatment, patients are followed every 3 months.

Arms: arm 1: Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib
Interventions: intervention 1: Erlotinib intervention 2: SBRT
Intervention descriptions: intervention 1: Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. intervention 2: SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body

Protocol documents:
Clinical trial NCT02120950
Conditions: Neovascular Macular Degeneration
Keywords: PCV
Sponsor: Bayer
Start date: 2014-05-29; Completion date: 2017-07-07
Enrollment: 333 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To collect data reflecting the efficacy and safety of aflibercept with and without photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy subtype of wet age-related macular degeneration

Detailed description:

Arms: arm 1: Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy) arm 2: Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy)
Interventions: intervention 1: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) intervention 2: Visudyne
Intervention descriptions: intervention 1: Eylea is administered as an intravitreal injection intervention 2: Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)

Protocol documents:
Clinical trial NCT02267356
Conditions: Onychomycosis
Sponsor: Viamet
Start date: 2015-02-17; Completion date: 2017-07-07
Enrollment: 259 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Several properties of VT-1161 suggest that it might be a safer and more effective treatment for onychomycosis of the toenail (also known as toenail fungus) than other oral antifungal medicines.

This study will evaluate the effectiveness and safety of VT-1161 for the treatment of toenail onychomycosis and consists of a screening phase, a 24-week treatment phase in which the patient will take either active drug, placebo or a combination of the 2 (according to random assignment), an initial observational phase of 36 weeks and an additional observational study extension of 9 months.

The additional 9-month observational study extension was added with a protocol amendment and patient participation was optional.

Detailed description:

Arms: arm 1: 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks arm 2: 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks arm 3: 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks arm 4: 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks arm 5: 4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
Interventions: intervention 1: VT-1161 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02356562
Conditions: Chronic Hepatitis C Infection
Keywords: Hepatitis C Interferon-Free Treatment Experienced Chronic Hepatitis C Hepatitis C Virus
Sponsor: AbbVie
Start date: 2015-02-03; Completion date: 2017-07-07
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir (SOF) and ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus infection. This study will contain 2 parts.

Part 1: Approximately 20 participants and at least 10 of the 20 participants previously treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without RBV, and experienced treatment failure.

Part 2: Approximately 10 participants and all participants previously treated with SOF/ledipasvir and experienced treatment failure.

Detailed description:
Efficacy, safety, and demographic analyses were performed separately for the 2 study parts using the intent-to-treat (ITT) population, which consists of all enrolled participants who received at least one dose of study drug.

Arms: arm 1: 3-DAA (ombitasvir/paritaprevir/ritonavir once daily \[QD\] and dasabuvir twice daily \[BID\]) with and without sofosbuvir (SOF) QD and with or without ribavirin (RBV) BID for 12 or 24 weeks
Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir and dasabuvir intervention 2: Sofosbuvir intervention 3: Ribavirin
Intervention descriptions: intervention 1: tablet, ombitasvir coformulated with paritaprevir and ritonavir; tablet, dasabuvir intervention 2: tablet intervention 3: tablet

Protocol documents: