ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02228395
Conditions: Healthy
Keywords: Single ascending doses pharmacokinetics safety tolerability healthy volunteers cognitive impairment associated with schizophrenia (CIAS)
Sponsor: Biogen
Start date: 2014-09-22; Completion date: 2014-11-13
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of single ascending doses in healthy volunteers

Detailed description:
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Arms: arm 1: Participants received 1 single dose of placebo, PF-04958242 0.6 mg, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing. arm 2: Participants received 1 single dose of PF-04958242 0.35 mg, placebo, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing. arm 3: Participants received 1 single dose of PF-04958242 0.35 mg, PF-04958242 0.6 mg, and placebo orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.
Interventions: intervention 1: PF-04958242 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered as specified in treatment arm intervention 2: Administered as specified in treatment arm

Protocol documents:
Clinical trial NCT01915940
Conditions: Primary Open-Angle Glaucoma Ocular Hypertension
Keywords: Glaucoma Primary Open-Angle Glaucoma Ocular Hypertension
Sponsor: ForSight Vision5, Inc.
Start date: 2013-10-23; Completion date: 2014-11-14
Enrollment: 169 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.

Detailed description:

Arms: arm 1: Washout and placebo ocular insert in each eye for at least 4 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye and placebo eye drops twice a day in each eye for 6 months. arm 2: Washout and placebo ocular insert in each eye for at least 4 weeks, followed by Timolol (timoptic ophthalmic solution 0.5%) twice a day in each eye plus placebo ocular insert for 6 months.
Interventions: intervention 1: Bimatoprost intervention 2: Timolol 0.5% intervention 3: Placebo Eye Drops intervention 4: Placebo Ocular Insert
Intervention descriptions: intervention 1: Bimatoprost ocular insert intervention 2: Timolol 0.5% solution intervention 3: Placebo topical eye drops intervention 4: Ocular insert without any active drug

Protocol documents:
Clinical trial NCT01086605
Conditions: Breast Cancer
Keywords: HER2-negative breast cancer male breast cancer recurrent breast cancer stage IV breast cancer stage IIIC breast cancer
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2010-05-01; Completion date: 2014-11-15
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as pixantrone dimaleate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pixantrone dimaleate in different ways may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well pixantrone dimaleate works in treating patients with HER2-negative metastatic breast cancer.

Detailed description:
OBJECTIVES:

Primary

* To assess the proportion of confirmed tumor responses at each dose level of pixantrone

Secondary

* To describe the distribution of progression-free survival (PFS) times of patients receiving pixantrone
* To assess the 6-month PFS rate in patients receiving each dose level of pixantrone
* To describe the overall survival distribution of patients receiving pixantrone
* To assess the adverse event profile of pixantrone in the treatment of patients with metastatic breast cancer.
* To evaluate the quality of life and patient-reported symptoms of patients receiving the study regimen

OUTLINE: This is a multicenter study. Patients are randomized according to prior doxorubicin treatment ( yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Some patients undergo blood sample collection at baseline and periodically during study for circulating tumor cells analysis by CellSearch System and mRNA isolation assays.

Patients complete quality-of-life questionnaires using the Linear Analogue Self Assessment (LASA6) and the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at baseline and periodically during study.

After completion of study therapy, patients are followed up every 3-6 months for up to 5 years.

Arms: arm 1: Patients receive pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: pixantrone dimaleate
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00849875
Conditions: Melanoma
Keywords: ASCI Dacarbazine Cancer immunotherapeutic MAGE-A3 Malignant melanoma
Sponsor: GlaxoSmithKline
Start date: 2009-05-26; Completion date: 2014-11-17
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this clinical trial is to find out how successfully, patients with progressive metastatic cutaneous melanoma, are able to develop an immune response to injections with the immunotherapeutic product GSK1572932A when given in combination with dacarbazine and evaluate the safety of this combination.

Detailed description:
This Protocol Posting has been updated following amendment 3, dated 16 October 2009. The sections impacted are :

* Enrollment, number of subjects
* Outcome measures
* Exclusion criteria

Arms: arm 1: All patients are to receive the same treatment consisting of 24 injections of the immunotherapeutic GSK2132231A combined with a course of 8 cycles of dacarbazine given at the beginning of the treatment
Interventions: intervention 1: Immunotherapeutic GSK2132231A intervention 2: Dacarbazine
Intervention descriptions: intervention 1: Intramuscular administration intervention 2: Intravenous administration Chemotherapy

Protocol documents:
Clinical trial NCT01550224
Conditions: Acute Myeloid Leukemia With 11q23-abnormality in Relapse
Sponsor: Steven E. Coutre
Start date: 2013-05-01; Completion date: 2014-11-17
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to first determine if temozolomide plus vorinostat in combination can control relapsed or refractory acute myeloid leukemia (AML) and determine if this combination can be safely taken. The study will look at the side effects of the Temozolomide plus Vorinostat in combination and whether the treatment schedule is tolerated.

Detailed description:
The primary endpoint of the study is to determine the clinical efficacy as determined by the rate of morphological complete remission, of 2 different treatment regimens of temozolomide and vorinostat administered to 2 distinct groups of participants patients with AML and poor prognostic features. Participants will be allocated to treatment on the basis of O6-methylguanine DNA methyltransferase (MGMT) promoter methylation status.

Arms: arm 1: Participants with methylated O6-methylguanine DNA methyltransferase (MGMT) promoter, ie, expected to have no expression of MGMT protein, will be assigned into Group 1, and will receive vorinostat 500 mg orally 3 times daily for 3 days, followed by conventional doses of temozolomide (200 mg/m2 for 7 days). arm 2: Participants with non-methylated O6-methylguanine DNA methyltransferase (MGMT) promoter, ie, expected to have expression MGMT protein, will be assigned to into Group 2, and will initially receive daily, low doses (protracted dose schedule) of temozolomide (100 mg/m2) for 14 days in an attempt to inactivate MGMT activity. Following the protracted dose schedule, participants will receive vorinostat 500 mg orally 3 times daily for 3 days, followed by conventional doses of temozolomide (200 mg/m2 for 7 days).
Interventions: intervention 1: Temozolomide intervention 2: Vorinostat
Intervention descriptions: intervention 1: An alkylating agent administered for induction per standard of care at 200 mg/m²/day for 7days. intervention 2: A synthetic hydroxamic acid derivative with antineoplastic activity administered for both groups at 500 mg orally 3 times daily for 3 days prior to Temozolomide 200 mg/m²/day.

Protocol documents:
Clinical trial NCT01614899
Conditions: Schizophrenia
Sponsor: Sumitomo Pharma Co., Ltd.
Start date: 2012-07-02; Completion date: 2014-11-17
Enrollment: 457 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with schizophrenia.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: SM-13496 40mg intervention 2: SM-13496 80mg intervention 3: Placebo
Intervention descriptions: intervention 1: once daily orally intervention 2: once daily orally intervention 3: once daily orally

Protocol documents:
Clinical trial NCT01841697
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-06-13; Completion date: 2014-11-17
Enrollment: 642 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a non-inferiority study comparing omarigliptin with sitagliptin in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy. The primary hypothesis is that after 24 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior to that in participants treated with sitagliptin. There will be a 2-week run-in period with placebo + metformin prior to the double-blind treatment period.

Detailed description:

Arms: arm 1: Participants receive omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continue pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may receive glimepiride (total daily dose of 1-6 mg) as rescue therapy. arm 2: Participants receive sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continue pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may receive glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Interventions: intervention 1: Omarigliptin intervention 2: Sitagliptin intervention 3: Placebo to omarigliptin intervention 4: Placebo to Sitagliptin intervention 5: Open-label Metformin intervention 6: Open-label Glimepiride
Intervention descriptions: intervention 1: Omarigliptin (MK-3102) 25 mg oral capsule once a week for 24 weeks intervention 2: Sitagliptin 100 mg oral tablet once a day for 24 weeks intervention 3: Placebo to omarigliptin 25 mg oral capsule once a week for 24 weeks intervention 4: Placebo to sitagliptin 100 mg oral tablet once a day for 24 weeks intervention 5: Metformin oral tablet(s) - total daily dose of ≥1500 mg, once or twice a day intervention 6: Glimepiride oral tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy

Protocol documents:
Clinical trial NCT01850615
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2013-09-23; Completion date: 2014-11-17
Enrollment: 323 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia, Europe, South America, and the United States of America (USA).

The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: Subjects will receive FIAsp combined with their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin. arm 2: Subjects will continue their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin.
Interventions: intervention 1: Faster-acting insulin aspart intervention 2: basal insulin
Intervention descriptions: intervention 1: Administrated subcutaneously (s.c., under the skin) at each main meal. intervention 2: Administrated subcutaneously (s.c., under the skin) once daily.

Protocol documents:
Clinical trial NCT01220973
Conditions: Prostate Cancer
Keywords: stage IV prostate cancer stage III prostate cancer recurrent prostate cancer stage IIB prostate cancer stage IIA prostate cancer
Sponsor: Rutgers, The State University of New Jersey
Start date: 2009-02-01; Completion date: 2014-11-18
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Atorvastatin calcium and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atorvastatin calcium together with celecoxib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving atorvastatin calcium together with celecoxib works in treating patients with rising PSA levels after local therapy for prostate cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the effect on the biological activity, as assessed by prostate-specific antigen (PSA) response, of atorvastatin calcium and celecoxib in patients with D0 prostate cancer.

Secondary

* To document the safety and feasibility of atorvastatin calcium and celecoxib in patients with early-stage prostate cancer.
* To evaluate the effects of the combination of atorvastatin calcium and celecoxib on nuclear factor-kB (NFkB), extracellular signal-regulated kinase (ERK), prostaglandin E2 (PGE2), and IL6 in peripheral blood mononuclear cells (PBMC).

OUTLINE: This is a multicenter study.

Patients receive oral atorvastatin calcium once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients may undergo blood sample collection at baseline and after completion of study therapy for correlative studies.

After completion of study therapy, patients are followed up every 3 months for 2 years.

Arms: arm 1: None
Interventions: intervention 1: atorvastatin calcium intervention 2: celecoxib intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01494532
Conditions: Parkinson Disease
Sponsor: GlaxoSmithKline
Start date: 2012-04-02; Completion date: 2014-11-18
Enrollment: 352 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double blind, fixed dose, parallel group study to characterize the dose response of ropinirole PR as adjunctive therapy to L-dopa in patients with late stage Parkinson's disease. The primary endpoint of this study, mean change from baseline in total awake time spent "off' is the same endpoint as used in the ropinirole PR pivotal study for advanced Parkinson's disease patients. This study includes a wide range of ropinirole doses (4-24mg) with the 8mg, 12mg, and 16mg per day doses powered to detect a 1.7 hour difference in total awake time spent "off" compared with placebo. The dose of Ldopa will remain stable through the study, unless the subject experiences tolerability issues that require an L-dopa dose reduction. Up to three L-dopa dose reductions are allowed, making a total reduction of up to approximately 30%. Keeping the L-dopa dose constant where possible is important to avoid confounding the efficacy data. Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.

Detailed description:

Arms: arm 1: active treatment 4, 8, 12, 16, or 24mg/day arm 2: placebo comparator 4, 8, 12, 16, or 24mg/day
Interventions: intervention 1: ropinirole/L-dopa intervention 2: placebo/L-dopa
Intervention descriptions: intervention 1: Ropinirole as adjunctive therapy with L-dopa intervention 2: Placebo as adjunctive therapy with L-dopa

Protocol documents:
Clinical trial NCT04222699
Conditions: Human Microbiome
Keywords: intranasal mupirocin topical chlorhexidine
Sponsor: VA Office of Research and Development
Start date: 2012-09-18; Completion date: 2014-11-18
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators propose to study the microbiome of the nose, throat and three skin sites in a population without current exposure to the healthcare environment: 80 community dwelling adults. We will characterize the microbial communities in these body sites (nose, throat, perirectal and three skin sites) over time using culture-independent techniques. The investigators will then "decolonize" the subjects. Subjects will receive intranasal mupirocin and topical chlorhexidine. The investigators will then compare the microbial communities at baseline and after decolonization within individuals. Our overall hypothesis is that the microbial composition of these sites and the response to decolonization is influenced by the healthcare environment and that decolonization leads to re-colonization with an increasing proportion of Gram-negative bacilli.

Detailed description:

Arms: arm 1: Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study.
Interventions: intervention 1: Mupirocin calcium ointment, 2% intervention 2: Topical Chlorhexidine, 4%
Intervention descriptions: intervention 1: Mupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth. intervention 2: Chlorhexidine is an antiseptic that fights bacteria.

Topical chlorhexidine is used to clean the skin to prevent infection that may be caused by surgery, injection, or skin injury.

Protocol documents:
Clinical trial NCT01969539
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2013-10-14; Completion date: 2014-11-21
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The general aim of this 1-day, open label, non-randomised, trial is to characterize the performance of two adapter devices designed to permit use of the Respimat® inhaler with patients requiring mechanical ventilation.

Detailed description:

Arms: arm 1: Patients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via tee adapter arm 2: Patients (all); previously intubated and ventilated; in need of bronchodilation with /CVT-R via ventilator adapter
Interventions: intervention 1: Combivent Respimat via tee adapter intervention 2: Combivent Respimat via ventilator adapter
Intervention descriptions: intervention 1: Patients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via tee adapter intervention 2: Patients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via ventilator adapter

Protocol documents:
Clinical trial NCT01604772
Conditions: Recurrent Oral Cavity Adenoid Cystic Carcinoma Recurrent Salivary Gland Carcinoma Salivary Gland Adenoid Cystic Carcinoma Stage IVA Major Salivary Gland Cancer AJCC v7 Stage IVA Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7 Stage IVB Major Salivary Gland Cancer AJCC v7 Stage IVB Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7 Stage IVC Major Salivary Gland Cancer AJCC v7 Stage IVC Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7
Sponsor: National Cancer Institute (NCI)
Start date: 2012-07-23; Completion date: 2014-11-22
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with progressive, recurrent, or metastatic adenoid cyst carcinoma (cancer). Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the confirmed response rate of patients with progressive, recurrent/metastatic adenoid cyst carcinoma (ACC) treated with v-akt murine thymoma viral oncogene homolog 1 (Akt) inhibitor MK2206 (MK-2206).

SECONDARY OBJECTIVES:

I. To evaluate the progression-free survival (PFS), overall survival (OS), and safety/tolerability for MK-2206 in these patients.

TERTIARY OBJECTIVES:

I. To explore potential genetic/cytogenetic/histopathologic predictors of clinical outcome (i.e., response, PFS, OS) to MK-2206.

II. To explore the hypothesis that MK-2206-mediated Akt inhibition and downregulation of v-myb avian myeloblastosis viral oncogene homolog (c-myb) protein levels in ACC tumors correlates to clinical outcome (i.e., response, PFS, OS).

OUTLINE:

Patients receive Akt inhibitor MK2206 orally (PO) once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of treatment, patients are followed up every 6 months for up to 3 years.

Arms: arm 1: Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Akt Inhibitor MK2206 intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents: