ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01021332
Conditions: Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia
Keywords: Vesomni Solifenacin succinate EC905 Tamsulosin hydrochloride OCAS Treatment Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia
Sponsor: Astellas Pharma Europe B.V.
Start date: 2010-04-26; Completion date: 2011-12-14
Enrollment: 1067 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.

Detailed description:
This is an open-label extension study following the double blind 905-CL-055 study

Arms: arm 1: Participants who received at least one dose of open-label fixed dose combination (FDC) treatment
Interventions: intervention 1: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) intervention 2: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
Intervention descriptions: intervention 1: oral intervention 2: oral

Protocol documents:
Clinical trial NCT01323634
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Start date: 2011-03-18; Completion date: 2011-12-14
Enrollment: 519 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.

Detailed description:
This is a randomized, double-blind, double-dummy, multi-centre parallel group study. Subjects who meet the eligibility criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment period. There will be a 7-day Follow-up period after the treatment period.

Arms: arm 1: Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA) arm 2: Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)
Interventions: intervention 1: Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg intervention 2: Fluticasone Propionate 250mcg/ salmeterol 50mcg
Intervention descriptions: intervention 1: inhalation powder intervention 2: inhalation powder

Protocol documents:
Clinical trial NCT01396278
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2011-07-01; Completion date: 2011-12-14
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to assess and compare efficacy and safety of BI 54903 at three different dosages (b.i.d)., fluticasone propionate hydrofluoroalkane (HFA) metered dose inhaler (MDI) at a dose of 440 mcg b.i.d and low dose fluticasone propionate 88 mcg b.i.d. over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled medium dose ICS therapy as demonstrated by a decrease in forced expiratory volume in one second (FEV1) range 10 to 25 % and an asthma control questionnaire-6 (ACQ-6) equal or greater than 1.5 at time of randomisation.

Detailed description:

Arms: arm 1: patient to receive Respimat inhaler containing low dose BI 54903 plus placebo matching hydrofluoroalkane (HFA) metered dose inhaler (MDI) arm 2: Respimat inhaler containing medium dose BI 54903 plus placebo matching HFA MDI arm 3: Respimat inhaler containing high dose BI 54903 plus placebo matching HFA MDI arm 4: Fluticasone HFA MDI containing 440 mcg ICS plus placebo matching Respimat inhaler arm 5: Fluticasone HFA MDI containing 88 mcg ICS plus placebo matching Respimat inhaler
Interventions: intervention 1: Placebo intervention 2: Fluticasone propionate intervention 3: BI 54903
Intervention descriptions: intervention 1: Placebo matching fluticasone propionate HFA MDI intervention 2: Fluticasone propionate HFA MDI intervention 3: BI 54903 via Respimat inhaler

Protocol documents:
Clinical trial NCT00571727
Conditions: Growth Hormone Insensitivity Syndrome
Keywords: growth insulin like growth factor Laron syndrome
Sponsor: Ipsen
Start date: 1991-05-20; Completion date: 2011-12-15
Enrollment: 92 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study was to evaluate the long-term safety and effectiveness of mecasermin (the study drug) in children with growth failure due to severe Primary insulin-like growth factor-1 deficiency (Primary IGFD).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: mecasermin
Intervention descriptions: intervention 1: injections BID of rhIGF-1, mecasermin

Protocol documents:
Clinical trial NCT00729612
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer squamous cell lung cancer
Sponsor: Greg Otterson
Start date: 2008-08-14; Completion date: 2011-12-16
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation given together with carboplatin works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the response rate, in terms of overall response rate (complete response and partial response), of paclitaxel albumin-stabilized nanoparticle formulation and carboplatin in patients with stage IIIB-IV or recurrent non-small cell lung cancer who are ineligible for treatment with bevacizumab.

Secondary

* To evaluate safety of this regimen in these patients.
* To describe the overall survival of these patients.
* To describe progression-free survival of these patients.

Tertiary Objectives

* To explore, in a pilot fashion, the activity of this regimen using predictive biomarkers including serum SPARC levels, methylation of SPARC in primary tumor samples and serum, Ras mutations, ERCC1 and SPARC immunohistochemistry, and serum miRNA expression profiles.

OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Paraffin-embedded tissue blocks or unstained slides and blood samples are collected for correlative studies. Samples are analyzed for serum SPARC by ELISA, Ras mutations, ERCC1 AND SPARC by immunohistochemistry, and serum miRNA expression profiling.

After completion of study treatment, patients are followed periodically.

Arms: arm 1: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and carboplatin IV over 1-2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: carboplatin intervention 2: paclitaxel albumin-stabilized nanoparticle formulation intervention 3: protein expression analysis intervention 4: immunoenzyme technique intervention 5: immunohistochemistry staining method intervention 6: laboratory biomarker analysis
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT01469637
Conditions: Healthy
Sponsor: Shire
Start date: 2011-11-07; Completion date: 2011-12-20
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole administered alone \& in combination with Multi MatriX system (MMX®) formulation of mesalazine/mesalazine (Lialda®; Mesavancol®; Mezavant®) (MMX Mesalazine/mesalamine).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: sulfamethoxazole + MMX placebo intervention 2: Sulfamethoxazole + MMX Mesalazine/mesalamine
Intervention descriptions: intervention 1: 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX Mesalazine/mesalamine placebo once daily (QD) orally for 3 days, then a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX Mesalazine/mesalamine placebo orally on Day 4. intervention 2: 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days, then a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4

Protocol documents:
Clinical trial NCT03465436
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2011-09-16; Completion date: 2011-12-20
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to determine how two doses of lasmiditan affected the heart in healthy participants. The study also evaluated how much lasmiditan got into the blood stream and how long it took the body to get rid of it. Information about side effects was collected. The study lasted a maximum of 46 days for each participant, not including screening.

Detailed description:

Arms: arm 1: A single, PO dose of 100 mg lasmiditan administered on Day 1 in one of four treatment periods. arm 2: A single, PO dose of 400 mg lasmiditan administered on Day 1 in one of four treatment periods. arm 3: Placebo for lasmiditan and placebo for moxifloxacin administered on Day 1 in one of four treatment periods. arm 4: A single, PO dose of moxifloxacin administered on Day 1 in one of four treatment periods.
Interventions: intervention 1: Lasmiditan intervention 2: Lasmiditan intervention 3: Placebo intervention 4: Moxifloxacin
Intervention descriptions: intervention 1: 100 mg administered orally (PO) intervention 2: 400 mg administered PO intervention 3: Placebo administered for lasmiditan or moxifloxacin intervention 4: 400 mg moxifloxacin administered PO

Protocol documents:
Clinical trial NCT00914927
Conditions: Thrombocytopenia Related to Chronic Liver Disease
Keywords: Thrombocytopenia chronic liver disease
Sponsor: Eisai Inc.
Start date: 2009-05-01; Completion date: 2011-12-21
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of once-daily Oral avatrombopagin subjects with chronic liver diseases and thrombocytopenia prior to elective surgical or diagnostic procedures, to evaluate the safety of short-term administration of avatrombopag and to evaluate the pharmacokinetics (PK) of E5501.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Avatrombopag intervention 2: Avatrombopag intervention 3: Placebo
Intervention descriptions: intervention 1: Avatrombopag first Dose 80 mg followed by 10 mg a day for up to 6 additional days intervention 2: Avatrombopag first Dose 80 mg followed by 20 mg a day for 3 days and then Placebo for 3 additional days intervention 3: Placebo or inactive substance once a day for up to 7 days

Protocol documents:
Clinical trial NCT00756717
Conditions: Breast Cancer
Keywords: MK-0752 Tamoxifen Letroxole
Sponsor: Loyola University
Start date: 2008-02-14; Completion date: 2011-12-21
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research project is to study the effect of a research (investigational) drug, MK-0752 combined with either tamoxifen or letrozole on breast cancer cells.

Tamoxifen and letrozole are standard hormone treatments used to treat breast cancers that are positive for the estrogen receptor. However, over time the breast cancer cells can become resistant to tamoxifen and letrozole. MK-0752 is in a class of drugs called gamma secretase inhibitors. Gamma secretase inhibitors may play a role in reversing the resistance to drugs such as tamoxifen and letrozole.

Detailed description:
OBJECTIVES

To evaluate the safety and tolerability of the gamma-secretase inhibitor MK-0752 in the pre-surgical setting in patients with early stage, estrogen receptor (ER) positive breast cancer, in combination with tamoxifen or an aromatase inhibitor (AI).

To establish the feasibility and success of multi-laboratory collaborations in evaluating clinical specimens and biomarker testing.

To provide preliminary data on the impact of MK-0752 on a panel of biomarkers involved in the notch signaling pathway.

Arms: arm 1: Oral gamma-secretase inhibitor drug MK-0752, 350 mg for three days, four days off, then three days on, over a period of 10 days
Interventions: intervention 1: MK-0752
Intervention descriptions: intervention 1: Women who are post menopausal will receive letrozole 2.5 mg by mouth one time per day for 24 days. Women who are pre menopausal, or who have a contraindication to letrozole will receive tamoxifen 20 mg orally one time per day for a period of 24 days. Starting on day 15 of this 24 day period all patients will receive the oral gamma-secretase inhibitor drug MK-0752 at a dose of 350 mg for three days on, then off four days, then three days on, for a total of 6 doses over a period of 10 days.

Protocol documents:
Clinical trial NCT01199289
Conditions: Asthma
Keywords: Amgen chronic inflammatory disease wheezing
Sponsor: Amgen
Start date: 2010-10-04; Completion date: 2011-12-21
Enrollment: 315 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.

Detailed description:

Arms: arm 1: Participants will receive the matching placebo administered as subcutaneous (SC) injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10. arm 2: Participants will receive AMG 140 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10. arm 3: Participants will receive AMG 210 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10. arm 4: Participants will receive AMG 280 mg administered as SC injections at Day 1 and weeks 1, 2, 4, 6, 8, and 10.
Interventions: intervention 1: AMG 827 intervention 2: Placebo
Intervention descriptions: intervention 1: SC injection. intervention 2: SC injection.

Protocol documents:
Clinical trial NCT01218126
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Start date: 2010-11-04; Completion date: 2011-12-21
Enrollment: 604 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomised, double-blind, parallel-group, multi-centre study evaluating three doses of losmapimod (2.5mg, 7.5 mg and 15 mg) twice daily (BID) versus placebo on exercise tolerance. Eligible subjects will be randomised to treatment after a one-week run-in period. The duration of the treatment period is 24 weeks. An estimated 1000 subjects will be screened to reach the target enrolment of approximately 600 randomised subjects.

Detailed description:

Arms: arm 1: losmapimod 2.5 mg arm 2: None arm 3: losmapimod 7.5 mg arm 4: losmapimod 15 mg
Interventions: intervention 1: losmapimod intervention 2: placebo
Intervention descriptions: intervention 1: comparison of different dosages of drug 2.5 mg, 7.5 mg or 15 mg intervention 2: placebo comparison with active

Protocol documents:
Clinical trial NCT00305695
Conditions: Hereditary Breast and Ovarian Cancer Syndrome Osteoporosis Ovarian Carcinoma
Sponsor: Gynecologic Oncology Group
Start date: 2005-11-28; Completion date: 2011-12-22
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying zoledronate to see how well it works compared to observation in maintaining bone mineral density in patients who are undergoing surgery to remove both ovaries. Zoledronate may prevent bone loss in patients who are undergoing surgery to remove the ovaries.

Detailed description:
PRIMARY OBJECTIVE:

I. Compare the effect of zoledronate vs observation on bone loss associated with surgery (at a minimum, any surgical procedure that results in removal of both ovaries) in patients undergoing excision of both ovaries.

SECONDARY OBJECTIVE:

I. Compare the change in bone mineral density of the bilateral hip in patients treated with these regimens.

TERTIARY OBJECTIVE:

I. Compare the effect of zoledronate vs observation on biochemical markers of bone resorption and bone formation (N-telopeptide and bone specific alkaline phosphatase) during 1 year of treatment.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

All patients undergo surgery, with removal of both ovaries, in month 1. All patients are requested to take calcium supplements twice daily and a multivitamin containing vitamin D once daily beginning in month 1 and continuing for up to 18 months.

ARM I: Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15.

ARM II: Patients are observed for 18 months after surgery.

In both arms, patients complete physical activity questionnaires at baseline and in months 3, 9, 15, and 18. Patients undergo bone mineral density test of lumbar spine and total hip at baseline and in months 9 and 18. Patients also undergo blood collection at baseline and periodically during the study for biomarker studies.

Arms: arm 1: Beginning 60-90 days after surgery, patients receive zoledronate IV over 15 minutes once in months 3, 9, and 15. arm 2: Patients are observed for 18 months after surgery.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Zoledronic Acid
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given IV

Protocol documents:
Clinical trial NCT01397162
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2011-07-21; Completion date: 2011-12-23
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses twice daily (b.i.d.) and fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA MDI) at a dose of 88 mcg b.i.d and placebo b.i.d. over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on short-acting-beta-agonist (SABA) prn therapy only as demonstrated by a decrease in forced expiratory volume in one second (FEV1) range10 to 25% and an asthma control questionnaire (ACQ-6) equal or greater than 1.5 at time of randomization

Detailed description:

Arms: arm 1: BI 54903 low dose 2 puffs twice daily (b.i.d.) via Respimat inhaler plus hydrofluoralkane (HFA) metered dose inhaler (MDI) matching placebo 2 puffs b.i.d. arm 2: BI 54903 medium dose 2 puffs b.i.d. via Respimat inhaler plus HFA MDI matching placebo 2 puffs b.i.d. arm 3: BI 54903 high dose 2 puffs b.i.d. via Respimat inhaler plus HFA MDI matching placebo 2 puffs b.i.d. arm 4: Fluticasone propionate 2 puffs twice b.i.d via HFA MDI plus placebo BI 54903 via Respimat inhaler 2 puffs b.i.d. arm 5: Placebo Respimat inhaler 2 puffs b.i.d. and placebo HFA MDI, 2 puffs b.i.d.
Interventions: intervention 1: Fluticasone propionate intervention 2: Placebo intervention 3: BI 54903
Intervention descriptions: intervention 1: Fluticasone propionate intervention 2: Placebo matching fluticasone propionate HFA MDI intervention 3: BI 54903

Protocol documents:
Clinical trial NCT01397201
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2011-07-01; Completion date: 2011-12-23
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses twice daily (b.i.d.), fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA MDI) at a dose of 220 mcg b.i.d. and placebo b.i.d. over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on low dose Inhaled corticosteroid (ICS) as demonstrated by a decrease in forced expiratory volume in one second (FEV1 (range 10-25%) and an asthma control questionnaire (ACQ-6) greater or equal 1.5 at time of randomisation

Detailed description:

Arms: arm 1: Respimat inhaler containing low dose BI 54903 plus placebo matching hydrofluoralkane (HFA) metered dose inhaler (MDI) arm 2: Respimat inhaler containing medium dose BI 54903 plus placebo matching HFA MDI arm 3: Respimat inhaler containing high dose BI 54903 plus placebo matching HFA MDI arm 4: Fluticasone HFA MDI containing ICS plus placebo matching Respimat inhaler arm 5: Placebo matching Respimat inhaler plus placebo matching HFA MDI
Interventions: intervention 1: Placebo intervention 2: BI 54903 intervention 3: Fluticasone propionate
Intervention descriptions: intervention 1: Placebo matching fluticasone propionate HFA MDI intervention 2: BI 54903 intervention 3: Fluticasone propionate

Protocol documents:
Clinical trial NCT00472290
Conditions: Hematology MDS Myelodysplastic Syndromes Thrombocytopenia
Keywords: Hematology MDS Myelodysplastic Syndromes Thrombocytopenia
Sponsor: Amgen
Start date: 2007-04-01; Completion date: 2011-12-26
Enrollment: 72 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label extension study of romiplostim for treatment of thrombocytopenia (platelet count ≤ 50 x 10\^9/L) in MDS subjects. The study is designed to assess the long-term safety of treatment with romiplostim, as measured by incidence of overall adverse events, the incidence of bleeding events, the utilization of platelet transfusions, and the duration of platelet response. The study will further describe the time to disease progression to acute myeloid leukemia (AML) and survival.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Romiplostim (formerly AMG 531)
Intervention descriptions: intervention 1: Subjects will begin the study at an initial dose of 750 µg.

Except for:

* Subject whose doses were escalated to doses higher than 750 µg AMG 531 weekly, and maintained a response per IWG guidelines for platelet response.
* Subjects who were stable at a lower dose of AMG 531 on the previous study. Doses will be adjusted throughout the study based on individual subject's platelet count.

Protocol documents:
Clinical trial NCT01370317
Conditions: Asthma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-06-01; Completion date: 2011-12-27
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose treatment with MK-1029 in adults with mild to moderate persistent asthma.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MK-1029 intervention 2: Placebo for MK-1029
Intervention descriptions: intervention 1: Five (5) X 100 mg capsules, orally, once daily for 28 days intervention 2: Five (5) X 100 mg capsules, orally, once daily for 28 days

Protocol documents: