ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01125774
Conditions: Migraine
Keywords: Menstrually related migraine migraine Premenstrual migraine
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-06-01; Completion date: 2011-04-08
Enrollment: 4548 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter study to test the hypothesis that telcagepant is superior to placebo in preventing perimenstrual migraines as measured by mean monthly headaches during the entire treatment period. This study will also evaluate the safety and tolerability of telcagepant for female migraine participants.

Detailed description:

Arms: arm 1: Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses. arm 2: Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
Interventions: intervention 1: Telcagepant intervention 2: Placebo
Intervention descriptions: intervention 1: Telcagepant 140 mg film coated tablet for oral administration intervention 2: Placebo to match telcagepant 140 mg film coated tablet for oral administration

Protocol documents:
Clinical trial NCT00599755
Conditions: Carcinoma Non-small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-01-01; Completion date: 2011-04-13
Enrollment: 68 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will use imaging to look at tumor response to combination chemotherapy of gemcitabine (Gem) and cisplatin (Cis) or gemcitabine and carboplatin (Carbo) in non small cell lung cancer (NSCLC).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Comparator: CT or MRI and FDG-PET intervention 2: Gemcitabine and Cisplatin or Gemcitabine and Carboplatin
Intervention descriptions: intervention 1: Participants have 4 computed tomography (CT) or magnetic resonance imaging (MRI) scans at screening, baseline, at the end of each treatment cycle (day 21 and day 42.) They also have FDG-PET scans, 2 at Baseline and one at the end of each treatment cycle. intervention 2: Gemcitabine administered intravenously at a dose of 1000-1250 mg/m\^2 on Day 1 and Day 8 of each cycle; Cisplatin administered intravenously at a dose of 60-85 mg/m\^2 or Carboplatin at a dose of 4-6 Area Under the Curve (AUC) on Day 1 of each cycle. Two cycles are given 3 weeks apart.

Protocol documents:
Clinical trial NCT01053988
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Safety Chronic Obstructive Pulmonary Disease Efficacy FEV1 COPD
Sponsor: GlaxoSmithKline
Start date: 2009-10-05; Completion date: 2011-04-14
Enrollment: 1031 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Purpose of this study is to assess the efficacy and safety of two strengths of the FF/GW642444 Inhalation Powder in subjects with chronic obstructive pulmonary disease (COPD)

Detailed description:

Arms: arm 1: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) arm 2: Inhaled Corticosteroid (ICS) arm 3: Long Acting Beta Agonist(LABA) arm 4: Placebo arm 5: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
Interventions: intervention 1: FF/GW642444 Inhalation Powder intervention 2: FF Inhalation Powder intervention 3: GW642444 Inhalation Powder intervention 4: Placebo
Intervention descriptions: intervention 1: Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD intervention 2: Inhaled Corticosteroid (ICS) intervention 3: Long Acting Beta Agonist(LABA) intervention 4: Placebo

Protocol documents:
Clinical trial NCT01299610
Conditions: Dermatitis, Atopic
Keywords: Atopic Dermatitis GW870086X TIS IGA
Sponsor: GlaxoSmithKline
Start date: 2010-12-01; Completion date: 2011-04-14
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is a randomised, double-blind, placebo-controlled study to assess the efficacy of GW870086X cream formulation in subjects with moderate to severe atopic dermatitis. Subjects will be assigned to take 3 out of the 4 possible treatments for 21 ±2 days: GW870086X 0.2% cream, GW870086X 2% cream, FP 0.05% cream (as a positive control) and placebo cream. All subjects will be randomised to receive placebo cream. Three index lesions located on the arms and/or legs (one on each) will be identified per subject and each treatment will be applied to the same lesion.

Detailed description:
This study is a randomised, double-blind, placebo-controlled study to assess the efficacy of GW870086X cream formulation in subjects with moderate to severe atopic dermatitis. The primary objective of this study is to assess 3 lesions using the Three Item Severity (TIS) score. The secondary objectives are to assess safety and tolerability of GW870086X, assess individual lesions using the Investigators Global Assessment (IGA) and to assess the pharmacokinetics of 21 days dosing of GW870086X administered as a cream. Twenty-five (25) subjects with atopic dermatitis will be randomised to receive placebo and 2 of the following treatments: GW870086X 0.2%, GW870086X 2%, FP 0.05% and placebo. All subjects will receive placebo. Subjects will apply all 3 treatments once daily during the 21 day treatment period. Three index lesions located on the arms and/or legs (one on each) will be identified per subject and each treatment will be applied to the same lesion throughout the 21±2 day treatment period. Each index lesion should represent the most common lesions for each patient i.e. not the most or least severe lesions.

Arms: arm 1: GW870086 2.0%, GW870086 0.2% \&amp; Placebo each applied to a separate specific lesion for 21±2 days. arm 2: GW870086 2.0%, FP 0.05% \&amp; Placebo each applied to a separate specific lesion for 21±2 days. arm 3: GW870086 0.2%, FP 0.05% \&amp; Placebo each applied to a separate specific lesion for 21±2 days.
Interventions: intervention 1: GW870086 2.0% intervention 2: GW870086 0.2% intervention 3: FP 0.05% intervention 4: Placebo
Intervention descriptions: intervention 1: White to slightly colored opaque cream intervention 2: White to slightly colored opaque cream intervention 3: White cream intervention 4: White to slightly colored opaque cream

Protocol documents:
Clinical trial NCT00233454
Conditions: Systemic Mastocytosis, Aggressive (ASM) Leukemia, Mast Cell Hematological Non-mast Cell Lineage Disease (AHNMD)
Sponsor: Jason Robert Gotlib
Start date: 2005-03-01; Completion date: 2011-04-16
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The safety and efficacy of midostaurin (PKC412), a novel investigational drug, will be evaluated on the basis of response rate, when administered to patients with aggressive systemic mastocytosis (ASM) or mast cell leukemia (MCL)

Detailed description:
This study assesses the activity and safety profile of twice-daily oral doses of midostaurin in patients with aggressive systemic mastocytosis (ASM) or mast cell leukemia (MCL) with or without associated clonal hematological non-mast cell lineage disease (AHNMD).

Aggressive systemic mastocytosis (ASM) and mast cell leukemia (MCL) are characterized by excessive bone marrow production of mast cells which can can infiltrate tissues and release harmful substances, resulting in organ damage. These diseases have very limited treatment options and poor prognosis. Existing treatments for in advanced mast cell disease, eg, interferon-alpha; corticosteroids; and/or cladribine, exhibit low response rates that are usually partial in nature.

Arms: arm 1: 100 mg midostaurin twice daily as oral capsules
Interventions: intervention 1: Midostaurin
Intervention descriptions: intervention 1: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR

Protocol documents:
Clinical trial NCT01004263
Conditions: Acute Migraine With or Without Aura in Adolescents
Keywords: acute migraine with or without aura in adolescents
Sponsor: Organon and Co
Start date: 2009-12-01; Completion date: 2011-04-18
Enrollment: 674 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To provide long term safety data for rizatriptan in children and adolescents. The primary hypothesis of the study is that rizatriptan is well tolerated in the long term treatment of acute migraine in pediatric patients age 12-17 years.

Detailed description:

Arms: arm 1: Rizatriptan benzoate
Interventions: intervention 1: rizatriptan benzoate
Intervention descriptions: intervention 1: Single dose of 5 mg or 10 mg orally disintegrating tablet at onset of migraine attack

Protocol documents:
Clinical trial NCT00801398
Conditions: Postoperative Pain
Keywords: Opioid tolerant Pediatric Pain Non malignant Malignant
Sponsor: Endo Pharmaceuticals
Start date: 2009-02-17; Completion date: 2011-04-18
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40).

This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.

Detailed description:

Arms: arm 1: Open-Label, 2 part ascending-dose multicenter study
Interventions: intervention 1: Oxymorphone IR
Intervention descriptions: intervention 1: Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs

Protocol documents:
Clinical trial NCT00985725
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Sponsor: Shire
Start date: 2009-10-29; Completion date: 2011-04-18
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of SPD489 for the treatment of executive function impairments (EFI) when used as an adjunct to stable, standard therapy in the setting of partial or full remission from recurrent Major Depressive Disorder (MDD) as measured by the Global Executive Composite (GEC) T-score of the Behavioral Rating Inventory of Executive Functioning - Adult Version (BRIEF-A).

Detailed description:

Arms: arm 1: SPD489 arm 2: Placebo
Interventions: intervention 1: SPD489 (Lisdexamfetamine dimesylate) intervention 2: Matching placebo
Intervention descriptions: intervention 1: Oral, 20, 30, 40, 50, 60, and 70mg capsules, once daily intervention 2: oral, once daily

Protocol documents:
Clinical trial NCT01424514
Conditions: Rhinitis
Sponsor: GlaxoSmithKline
Start date: 2010-12-01; Completion date: 2011-04-18
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the pharmacodynamic (PD) effects (Total Symptom Score (TSS) and its individual components: rhinorrhoea, nasal congestion, post-nasal drip) of intranasal, repeat dose SB-705498 in non-allergic rhinitis (NAR) patients elicited by a cold dry air challenge in an environmental exposure chamber (EEC). SB-705498 is a selective antagonist of the transient receptor potential vanilloid-1 (TRPV1) ligand gated ion channel. TRPV1 is a cation permeable ion channel that can be activated by several physiological factors, such as heat, protons (pH), osmotic stress, eicosanoid derivatives, anandamide, and by products of inflammation, such as histamine, prostaglandins and bradykinin. In the nose, the local TRPV1 expressing sensory C-fibres are thought to play a key role in the development of nasal hyper-responsiveness to environmental provocateurs. It has been proposed that blocking the nasal sensory nerve stimulation may control nasal hyper-responsiveness and therefore prevent the induction of rhinitis symptoms. In this context, preclinical evidence supports that targeting TRPV1 by SB-705498 may be an attractive option.

In this study NAR patients will be randomised, in a double blind, placebo controlled cross over design to receive 14 day repeat doses of 12mg intra-nasal SB-705498 once daily. Whilst dosing at home, subjects will record symptom scores to document their symptoms. In addition, during visits to the clinical unit, acoustic rhinometry, quality of life questionnaires and safety assessments will be monitored.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SB-705498 intervention 2: Placebo
Intervention descriptions: intervention 1: 12mg intra nasal intervention 2: Placebo intra nasal

Protocol documents:
Clinical trial NCT00866684
Conditions: Skin Cancer
Keywords: Renal transplant-patients with high-risk for skin cancer
Sponsor: Charite University, Berlin, Germany
Start date: 2007-01-01; Completion date: 2011-04-19
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Transplant recipients have a high risk to develop skin malignancies. This effect depends on the one hand on the immunosuppressive drugs themselves (i.e., azathioprine) and relates on the other hand on the dosage (i.e., calcineurin-inhibitors). Based on the encouraging results of previous, retrospective studies on patients treated with Sirolimus (SRL), these patients should be switched to an immunosuppressive regime including SRL, decreasing the dosage of calcineurin-inhibitors or converting from former immunosuppression. A conversion to a SRL-based therapy is effective in immunosuppression and safe regarding graft and patient survival.

This study was designed to assess whether a switch to a SRL-immunosuppressive therapy decreases the incidence/reoccurrence of skin neoplasm.

Detailed description:
Patients who meet all inclusion criteria will be included into the study and randomised. If converted to SRL, patients will take SRL according to the investigator's instructions and medication label, once daily preferably 4 hours after calcineurin-inhibitor medication or in case without calcineurin-inhibitor co-medication in the morning. The dose of SRL will be correlated to the former immunosuppressive therapy according to the study's conversion protocol.

Arms: arm 1: Patients will receive Sirolimus in addition to their previous immunosuppressive therapy. arm 2: Patients will stay on their previous immunosuppressive regimen.
Interventions: intervention 1: Sirolimus intervention 2: Azathioprine intervention 3: Mycophenolate intervention 4: Ciclosporin intervention 5: Tacrolimus
Intervention descriptions: intervention 1: Treatment arm Dosage: 4-8 micrograms/litre; Route of administration: oral use; Frequency: one tablet per day intervention 2: control arm Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month intervention 3: Control arm Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month intervention 4: Control arm Dosage form: Capsule; Dosage: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month intervention 5: Control arm Dosage form: Capsule; dosage: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month

Protocol documents:
Clinical trial NCT00069121
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2003-04-18; Completion date: 2011-04-21
Enrollment: 1886 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: Participants were given one of two regimens (each participating center prespecified which regimen they would use for all patients at that center): i) Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or; ii) Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks). arm 2: Capecitabine was administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks).
Interventions: intervention 1: Capecitabine intervention 2: Oxaliplatin intervention 3: Leucovorin (LV) intervention 4: 5-Fluorouracil (5-FU)
Intervention descriptions: intervention 1: 1000 milligrams per square metre of body surface area (mg/m\^2) orally twice daily on days 1-15 of each 3-week cycle. intervention 2: 130 mg/m\^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle. intervention 3: Administered by one of two regimens, as specified in the arm description. intervention 4: Administered by one of two regimens, as specified in the arm description.

Protocol documents:
Clinical trial NCT01001234
Conditions: Migraine, Acute
Sponsor: Organon and Co
Start date: 2009-11-30; Completion date: 2011-04-21
Enrollment: 1382 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Clinical Trial evaluates the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: rizatriptan intervention 2: placebo intervention 3: rizatriptan intervention 4: placebo
Intervention descriptions: intervention 1: For participants randomized to rizatriptan in Stage 1: a single 5 or 10 mg rizatriptan orally disintegrating tablet (ODT) was to be taken within 30 minutes of onset of qualifying migraine (defined as a migraine of moderate or severe intensity).

Rizatriptan dose administered was based on participant weight at Screening: those \<40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet. intervention 2: For participants randomized to placebo in Stage 1: a single placebo ODT was to be taken within 30 minutes of onset of qualifying migraine. intervention 3: For participants randomized to rizatriptan in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder \[moderate or severe pain 15 minutes after dose\] to be randomized at Stage 2): a single 5 or 10 mg rizatriptan ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1.

Rizatriptan dose administered was based on participant weight at Screening: those \<40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet. intervention 4: For participants randomized to placebo in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder to be randomized at Stage 2) or allocated to placebo in Stage 2 (took rizatriptan in Stage 1 and was Non-Responder): a single placebo ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1.

Protocol documents:
Clinical trial NCT00500760
Conditions: Head and Neck Cancer Squamous Cell Carcinoma
Keywords: Head and Neck Cancer panitumumab
Sponsor: Amgen
Start date: 2007-10-01; Completion date: 2011-04-26
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The addition of chemotherapy to radiotherapy (chemoradiation) has improved outcomes for patients with locally advanced squamous cell carcinoma of the head and neck but additional improvements to treatment regimens are needed. The study is investigating if the addition of a targeted therapy (panitumumab) can improve the efficacy of chemoradiation without adding unmanageable toxicity.

Detailed description:

Arms: arm 1: Participants received standard radiation therapy for 7 weeks and cisplatin 75 mg/m\^2 and panitumumab 9 mg/kg on Days 1, 22 and 43. arm 2: Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m\^2 on Days 1, 22, and 43.
Interventions: intervention 1: Cisplatin intervention 2: Standard Fractionation Radiotherapy intervention 3: Panitumumab
Intervention descriptions: intervention 1: Administered intravenously (IV; in a vein) intervention 2: 70 Gy administered in 2 Gy fractions daily for 5 days a week for 7 weeks (35 fractions) intervention 3: Administered intravenously

Protocol documents: