ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01380093
Conditions: Nondependent Opioid Abuse, Episodic
Keywords: abuse potential abuse liability recreational opioid use morphine
Sponsor: Pfizer
Start date: 2011-02-01; Completion date: 2011-05-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary purpose of this study is to determine the abuse potential of EMBEDA compared to controlled release morphine when crushed and taken orally by non-dependent recreational opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA relative to placebo and and to compare the pharmacokinetics and safety of crushed EMBEDA with crushed controlled-release morphine and crushed placebo.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Placebo intervention 2: MS Contin (morphine sulfate, controlled release) intervention 3: EMBEDA (morphine sulfate / naltrexone hydrochloride)
Intervention descriptions: intervention 1: Single-dose, 2 x microcrystalline cellulose (weighed to equal weights of average tablet/capsule of active comparator) mixed with 150 ml artificially sweetened, non-carbonated beverage intervention 2: Single-dose, 2 x 60 mg morphine sulfate whole tablets manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage intervention 3: Single-dose, solution 2 x 60 mg morphine sulfate with sequestered 2.4 mg Naltrexone hydrochloride whole capsules manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage

Protocol documents:
Clinical trial NCT01435460
Conditions: Seasonal Allergic Conjunctivitis
Keywords: ocular allergy
Sponsor: Bausch & Lomb Incorporated
Start date: 2010-08-01; Completion date: 2011-05-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%) versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).

Detailed description:

Arms: arm 1: Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2% arm 2: Ophthalmic solution containing olopatadine, 0.1%
Interventions: intervention 1: Loteprednol etabonate 0.2% intervention 2: Olopatadine 0.1%
Intervention descriptions: intervention 1: 1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks. intervention 2: 1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.

Protocol documents:
Clinical trial NCT01628926
Conditions: Parkinson's Disease
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2009-06-01; Completion date: 2011-05-01
Enrollment: 420 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
* To demonstrate the non-inferiority of SPM 962 to ropinirole in terms of efficacy in order to confirm clinical value of SPM 962.
* To demonstrate the superiority of SPM 962 to placebo in terms of efficacy.
* To investigate the tolerability and safety of SPM 962 up to 36.0 mg/day.

Detailed description:

Arms: arm 1: SPM 962 transdermal patch arm 2: Ropinirole tablet arm 3: SPM962 placebo patch and Ropinirole placebo tab
Interventions: intervention 1: SPM 962 intervention 2: Ropinirole intervention 3: Placebo
Intervention descriptions: intervention 1: SPM 962 transdermal patch once a daily up to 36.0 mg/day intervention 2: Ropinirole oral administration TID up to 15.0 mg/day intervention 3: SPM962-placebo patch and Ropinirole-placebo tab

Protocol documents:
Clinical trial NCT01700530
Conditions: Metabolic Syndrome Obese Sedentary
Keywords: mitochondria fitness statins cholesterol metabolic syndrome
Sponsor: University of Kansas Medical Center
Start date: 2007-05-01; Completion date: 2011-05-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Here we tested if statins or exercise plus statins had a greater capacity to lower metabolic syndrome risk factors in sedentary individuals with at least 2 metabolic syndrome risk factors. We also examined if statins impacted exercise response for mitochondrial content in muscle or aerobic fitness.

Detailed description:
OBJECTIVES: Determine if simvastatin impairs exercise training adaptations.

BACKGROUND: Statins are commonly prescribed in combination with therapeutic lifestyle changes, including exercise, to reduce cardiovascular disease risk in patients with the metabolic syndrome. Statin use has been linked to skeletal muscle myopathy and impaired mitochondrial function, but it is unclear whether statin use alters adaptations to exercise training.

METHODS: We examined the effects of simvastatin on changes in cardiorespiratory fitness and skeletal muscle mitochondrial content in response to aerobic exercise training. Sedentary overweight or obese adults with at least 2 metabolic syndrome risk factors (defined according to National Cholesterol Education Panel Adult Treatment Panel III criteria) were randomized to 12 weeks of aerobic exercise training or to exercise in combination with simvastatin (40 mg per day). The primary outcomes were cardiorespiratory fitness and skeletal muscle (vastus lateralis) mitochondrial content (citrate synthase enzyme activity).

Arms: arm 1: Statins (40mg/day)for an average of 12 weeks arm 2: 12 weeks of exercise training (5 days a week for 45-50 min a session) arm 3: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks
Interventions: intervention 1: Statin intervention 2: Exercise only intervention 3: Statins + Exercise
Intervention descriptions: intervention 1: Statins (40mg/day)for 12 weeks intervention 2: 12 weeks of exercise training (5 days a week for 45-50 min a session) intervention 3: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks

Protocol documents:
Clinical trial NCT00879658
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: Multiple Sclerosis (MS) Relapsing-Remitting Demyelinating Autoimmune Diseases Disseminated sclerosis Encephalomyelitis disseminate Inflammatory disease Demyelination Auto-inflammatory disease Devic's disease Balo concentric sclerosis Schilder's diffuse sclerosis
Sponsor: Novartis Pharmaceuticals
Start date: 2009-03-30; Completion date: 2011-05-04
Enrollment: 297 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine the dose-response curve for the MRI-based efficacy of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), and to characterize its safety and tolerability for the selection of an optimal dose in a later phase III study.

Study Design Rationale An adaptive design was chosen to characterize the dose response curve of BAF312. In a first period of study ("Period 1"), three doses of BAF312 and placebo were tested for MRI efficacy. Based on an interim analysis (IA) after 3 months of treatment, two additional active doses for period 2 wereselected , thus allowing to optimize the overall determination of the dose response curve with 5 data points of active treatment, and placebo. The doses were kept blinded. The use of Modeling and Simulation allowed to establish the full range and dynamics of the dose-response curve in silico, and hence the definition of the optimal dose for later phase III studies.

The choice of placebo as treatment control was essential to obtain information on the specific compared to non-specific effects of active treatment and provides the best way of evaluating the efficacy and of assessing the true safety and tolerability profile of BAF312. Short-term placebo exposure (6 (Period 1) or 3 (Period 2) months, respectively) was unlikely to lead to longer term differences in outcomes \[Polman, 2008\]. The use of an adaptive design strategy contributed to a significant reduction of placebo exposure, both in terms of the number of patients and duration, as compared to conventional trial models.

Patients having completed the study within the protocol might be eligible for the Extension Phase study where they receive long-term BAF312 treatment (a separate protocol).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: BAF312 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01021553
Conditions: Premature Ejaculation
Keywords: Proof of Concept Double Blind
Sponsor: GlaxoSmithKline
Start date: 2009-12-23; Completion date: 2011-05-05
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if an on demand dosing of 50 mg or 150 mg of GSK557296 demonstrates superior efficacy with respect to duration of intra vaginal ejaculatory latency time (IELT) during an 8 week study period compared to placebo in men with primary premature ejaculation. An assessment of the safety and tolerability of all doses of GSK557296 will be performed as well as an assessment for change in the Index of Premature Ejaculation (IPE) from baseline and at the end of the 8 weeks of treatment. During the active treatment period study participants will be limited to a maximum of 40 doses of GSK557296, or placebo, spilt as 20 doses for both 4 week intervals.

Detailed description:

Arms: arm 1: placebo arm 2: 50 mg GSK557296 arm 3: 150 mg GSK557296
Interventions: intervention 1: GSK557296 intervention 2: GSK557296 intervention 3: placebo
Intervention descriptions: intervention 1: 50 mg GSK557296 intervention 2: 150 mg GSK557296 intervention 3: placebo

Protocol documents:
Clinical trial NCT00754065
Conditions: Contraception
Keywords: Oral contraceptive Estradiol valerate and dienogest EV/DNG comparative tolerability
Sponsor: Bayer
Start date: 2008-09-08; Completion date: 2011-05-10
Enrollment: 409 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50 years of age who request oral contraceptive protection. Subjects on a levonorgestrel (LNG), norgestimate (NGM), norethindrone or norethindrone acetate containing oral contraceptive in a 21-day regimen suffering from hormone withdrawal-associated symptoms such as pelvic pain or headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho Tri-Cyclen Lo.

Detailed description:
Safety issues are addressed in the Adverse Events section.

Arms: arm 1: Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated) arm 2: Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)
Interventions: intervention 1: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027) intervention 2: Ortho Tri Cyclen Lo
Intervention descriptions: intervention 1: Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated BAY86-5027 for 28 days per Cycle, for 13 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo intervention 2: Dose--Ethinylestradiol (EE) + Norgestimate (NGM) Triphasic 21-day regimen. Daily oral administration of one encapsulated Ortho Tri-Cyclen Lo for 28 days per Cycle, for 13 treatment cycles: Days 1-7, 0.025 mg EE+0.180 NGM; Days 8-14, 0.025 mg EE+0.215 NGM; Days 15-21, 0.025 mg EE+0.250 NGM; Days 27-28, placebo

Protocol documents:
Clinical trial NCT00531232
Conditions: Myelodysplastic Syndromes Secondary Acute Myeloid Leukemia (AML)
Keywords: Previously treated MDS oral clofarabine Intermediate-1, Intermediate-2 and High Risk MDS secondary AML (with history of MDS)
Sponsor: Genzyme, a Sanofi Company
Start date: 2007-05-07; Completion date: 2011-05-12
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There was no well accepted standard of care for participants who failed or were intolerant to any of the currently approved therapies for myelodysplastic syndromes (MDS). In this study, participants were initially assigned to receive 55 or 35 milligrams (mg) of oral clofarabine daily for 5 days. After safety review of the first participants enrolled, the dose was reduced to 25 milligrams per day (mg/day) for up to 8 cycles as long as the participants continued to benefit and in the absence of progressive disease.

Detailed description:

Arms: arm 1: Participants received Clofarabine 55 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years). arm 2: Participants received Clofarabine 35 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years). arm 3: Participants received Clofarabine 25 mg/day orally for 5 consecutive days of each 28-day treatment cycle until disease progression or death, whichever comes first (maximum study duration: up to 4 years).
Interventions: intervention 1: Clofarabine
Intervention descriptions: intervention 1: Pharmaceutical form: Tablet,

Route of administration: Oral

Protocol documents:
Clinical trial NCT00539617
Conditions: Esophageal Cancer
Keywords: metastatic esophageal cancer erlotinib folfox advanced esophageal cancer unresectable esophageal cancer
Sponsor: University of California, San Francisco
Start date: 2007-10-05; Completion date: 2011-05-12
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the safety and effectiveness of erlotinib and FOLFOX in patients with esophageal or gastro-esophageal cancer that cannot be removed by surgery.

Detailed description:
More than 50% of patients with advanced esophageal cancer present with disease that cannot be removed by surgery or has spread to other parts of the body. Improved therapies for patients with advanced esophageal cancer are therefore urgently needed. The epidermal growth factor receptor (EGFR) inhibitor erlotinib (in combination with chemotherapy) has lead to improved survival in patients with pancreatic and lung cancer. EGFR is a target in esophageal cancer therapy since its overexpression is associated with more aggressive disease and poor survival. Early studies have shown some clinical activity of EGFR inhibitors in this disease alone or in combination with chemotherapy. This study aims to explore how safe and effective treatment with erlotinib and FOLFOX is in patients with advanced esophageal or gastro-esophageal cancer.

Arms: arm 1: COMBINATION THERAPY PHASE: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-56. Patients also receive FOLFOX6 therapy comprising oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46-48 hours on days 1, 15, 29, and 43. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease or no evidence of disease after course 2 or subsequent courses continue on to maintenance phase.

MAINTENANCE PHASE: Patients receive erlotinib hydrochloride PO QD on days 1-42. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Erlotinib intervention 2: 5-fluorouracil intervention 3: Leucovorin intervention 4: Oxaliplatin
Intervention descriptions: intervention 1: Tarceva single agent therapy: 150 mg/day PO intervention 2: 5-FU bolus: 400 mg/m2 IV once every 2 weeks for 16 weeks 5-FU infusion: 2400 mg/m2 IV over 46-48 hours, once every 2 weeks for 16 weeks intervention 3: 400 mg/m2 IV once every 2 weeks for 16 weeks intervention 4: 85 mg/m2 IV once every 2 weeks for 16 weeks

Protocol documents:
Clinical trial NCT00635167
Conditions: Prostate Cancer
Keywords: Prostate cancer prostatic vascularity External Beam Radiation treatment Contrast Enhanced transrectal Ultrasound
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Start date: 2007-06-01; Completion date: 2011-05-12
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Solid tumors, including prostate cancer, commonly exhibit tumor-associated neovascularity (growth of new blood vessels to feed the tumor) with increased microvessel density. Systemic, hormonal, and radiotherapy treatments typically decrease or suppress tumor - associated vascularity through several mechanisms, including apoptosis (process of cell death) and anti-angiogenic pathways (ways to destroy new blood vessel growth). Previously at the investigators' center, they have demonstrated that increased prostatic vascularity (blood vessels defined to prostate) detected ultrasonographically correlated with disease free survival after radical prostatectomy (surgical removal of entire prostate), and may be indicative of higher grade, higher stage disease. The significance of prostate neovascularity in response to treatment with external beam radiotherapy (EBRT) (standard of care) has not been well studied. The investigators hypothesize that prostate cancer that recurs after radiotherapy may exhibit measurable patterns of tumor-associated vascularity, which may represent a minimally invasive marker of cancer stage, grade and response to treatment. The investigators propose a pilot study to assess the feasibility of serial enhanced transrectal ultrasonography (TRUS) examinations during and after radiotherapy for prostate cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Contrast Enhanced-Transrectal Ultrasound
Intervention descriptions: intervention 1: Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline \[Visit 2\]); week 5 (middle of treatment \[Visit 3\]); week 10 (end of treatment \[Visit 4\]); week 18 (2 months after end of EBRT \[Visit 5\]); week 26 (4 months after end of EBRT \[Visit 6\]); and week 36 (6 months after end of EBRT \[Visit 7\]).

Protocol documents:
Clinical trial NCT01018186
Conditions: Asthma
Sponsor: GlaxoSmithKline
Start date: 2009-10-19; Completion date: 2011-05-12
Enrollment: 503 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the long-term safety of fluticasone furoate/GW642444

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fluticasone Furoate/GW642444 intervention 2: Fluticasone propionate
Intervention descriptions: intervention 1: Combination inhaled corticosteroid and long-acting beta2-agonist intervention 2: Inhaled corticosteroid

Protocol documents:
Clinical trial NCT01131325
Conditions: CML Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels
Keywords: Philadelphia chromosome positive Ph+ chronic myelogenous leukemia chronic phase CML-CP low imatinib trough levels
Sponsor: Novartis Pharmaceuticals
Start date: 2010-10-21; Completion date: 2011-05-12
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: nilotinib
Intervention descriptions: intervention 1: All patients will receive nilotinib 300mg bid po daily. Nilotinib dose is taken every 12 hours

Protocol documents:
Clinical trial NCT01131351
Conditions: Tuberculosis
Keywords: MDR-TB Dose Escalation Phase II Open Label Non Controlled Pulmonary Multidrug-Resistant Tuberculosis (MDR TB)
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2010-02-19; Completion date: 2011-05-12
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is:

* To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily to MDR tuberculosis (TB) participants refractory to treatment with an optimized background regimen of anti-TB medications (OBR).
* To evaluate the pharmacokinetics (PK) of OPC-67683 and metabolites.

Detailed description:

Arms: arm 1: Participants received delamanid five 50 milligrams (mg) (250 mg) tablets, twice a day (BID), along with at least 2 additional anti-TB medications per optimized background regimen (OBR) for up to 28 weeks. arm 2: Participants received delamanid six 50 mg (300 mg) tablets, BID, along with at least 2 additional anti-TB medications per OBR for up to 28 weeks.
Interventions: intervention 1: Delamanid intervention 2: Optimized Background Regimen (OBR)
Intervention descriptions: intervention 1: OPC-67683 film-coated tablets intervention 2: OBR was selected at the discretion of the study investigator and included at least 2 anti-TB medications based on World Health Organization (WHO's) guidelines for the programmatic management of drug-resistant TB. Study investigator could change OBR for a participant based on his/her tolerability and drug susceptibility testing (DST) results.

Protocol documents:
Clinical trial NCT00483509
Conditions: Small Cell Lung Cancer
Keywords: NGR-hTNF SCLC
Sponsor: AGC Biologics S.p.A.
Start date: 2007-02-14; Completion date: 2011-05-17
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic small cell lung carcinoma (SCLC) patients previously treated with at least one therapeutic regimen

Detailed description:
This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic SCLC, previously treated with at least one therapeutic regimen, that will be conducted using Simon's two-stage design method.

Arms: arm 1: NGR-hTNF plus doxorubicin
Interventions: intervention 1: NGR-hTNF intervention 2: Doxorubicin
Intervention descriptions: intervention 1: iv q3W 0.8 mcg/sqm NGR-hTNF intervention 2: iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion

Protocol documents: