ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01651936
Conditions: Rheumatoid Arthritis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-08-29; Completion date: 2013-10-08
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate (MTX) in participants with active rheumatoid arthritis (RA) and an inadequate response or intolerance to anti-tumor necrosis factor α (anti-TNF-α) therapy. The primary hypothesis of this study is that among participants with active RA, MK-8457 100 mg twice daily (BID) + MTX will be superior to placebo + MTX as measured by the change in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) after 12 weeks of treatment.

Detailed description:
In the Base Study, participants were to receive blinded MK-8457 100 mg + MTX or matched placebo + MTX for up to 24 weeks. At Week 12 and 18, efficacy evaluation was conducted to assess eligibility for early escape, defined as \<20% improvement in tender and swollen joint counts. Participants who completed the Base Study and those eligible for early escape could enroll in the 76-week Safety Extension in which participants were to receive open-label MK-8457 100 mg BID + MTX.

All participants must have been treated with MTX for at least 3 months prior to Screening and have been receiving a stable dose of MTX for at least 4 weeks prior to Screening. In addition, each participant must have either failed treatment with 1 or 2 anti-TNF-α therapies or was intolerant to anti-TNF-α therapy prior to Screening. For participants who failed therapy, the treatment with anti-TNF-α therapies must have been for at least 3 months.

Arms: arm 1: Participants received MK-8457 100 mg dosed twice daily (BID) orally with MTX at the stable dose received upon study enrollment. The Base Study lasted up to 24 weeks. arm 2: Participants received placebo BID orally with MTX at the stable dose received upon study enrollment. The Base Study lasted up to 24 weeks. arm 3: Participants received MK-8457 100 mg dosed twice daily (BID) orally with MTX at the stable dose received upon study enrollment. The Safety Extension was to last up to 76 weeks.
Interventions: intervention 1: MK-8457 100 mg intervention 2: Methotrexate intervention 3: Dose-match placebo
Intervention descriptions: intervention 1: MK-8457 100 mg dosed orally BID intervention 2: MTX dosed at the stable dose received upon study entry intervention 3: Dose-matched placebo dosed orally BID

Protocol documents:
Clinical trial NCT01324830
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2011-04-15; Completion date: 2013-10-10
Enrollment: 69 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The aim of the Phase Ia (dose escalation) part of this trial is to assess the maximum tolerated dose (MTD) of BI 847325 administered at escalating doses in 2 treatment arms. In the Phase Ib expansion part of the trial, the aim is to further evaluate the safety profile of BI 847325 at the recommended dose and schedule and to assess target modulation and the potential antitumour efficacy in patients with selected tumour types.

Detailed description:

Arms: arm 1: 14 days once a day oral intake of BI 847325 followed by 7 days break in 3-week cycles arm 2: 5 days once daily oral intake of BI 847325 followed by 2 days break, repeated every week
Interventions: intervention 1: day 1 to day 5 intervention 2: day 1 to day 14
Intervention descriptions: intervention 1: low to high dose intervention 2: low to high dose

Protocol documents:
Clinical trial NCT00711802
Conditions: Skin Diseases, Infectious
Keywords: Complicated Skin Structure
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2008-07-23; Completion date: 2013-10-11
Enrollment: 396 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy, and pharmacokinetics (PK) of daptomycin in pediatric subjects ages 1 to 17 years, inclusive, with complicated skin and skin structure infections (cSSSI) caused by Gram-positive pathogens.

Detailed description:
This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy, and PK of daptomycin in pediatric participants ages 1 to 17 years, inclusive, with cSSSI caused by Gram-positive pathogens. Participants will be enrolled into age groups and given age-dependent doses over a period of up to 14 days. Participants will be stratified by age group to receive either daptomycin or SOC (recommended as vancomycin, clindamycin or semisynthetic penicillin) in a ratio of 2:1, respectively. Participants may continue on oral therapy following completion of IV study drug administration and provided that the participant meets all criteria for conversion to oral therapy, including clear clinical improvement and availability of an oral agent to which the pathogen is susceptible. The choice of oral therapy will be left to the discretion of the Investigator. February 11, 2015 released from post marketing requirement to include subjects aged 3 months - \< 1 year. Ref ID: 3701325

Arms: arm 1: Administered intravenously (IV) every 24 hours for up to 14 days at the following age-dependent dosages.

Participants ages 7 to 17 years: daptomycin was dissolved in a volume of 50 milliliters (mL) 0.9% sodium chloride for injection over 30 minutes (min) with an infusion rate of 1.67 mL/min.

Participants 1 to 6 years-old: daptomycin was dissolved in a volume of 25 mL 0.9% sodium chloride for injection over 60 min with an infusion rate was 0.42 mL/min.

Age Group 1 (for ages 12 to 17 years): 5 milligrams/kilogram (mg/kg)

Age Group 2 (for ages 7 to 11 years): 7 mg/kg

Age Group 3 (for ages 2 to 6 years): 9 mg/kg

Age Group 4 (for ages 1 to \<2 years): 10 mg/kg arm 2: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Interventions: intervention 1: Daptomycin intervention 2: Standard of Care (SOC)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01516879
Conditions: Hypercholesterolemia
Keywords: Cholesterol High Cholesterol Elevated Cholesterol Raised Cholesterol
Sponsor: Amgen
Start date: 2012-01-05; Completion date: 2013-10-14
Enrollment: 905 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.

Detailed description:
Eligible participants with screening central laboratory low-density lipoprotein cholesterol (LDL-C) values ≥ 75 mg/dL (1.9 mmol/L) were instructed to follow National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP) Therapeutic Lifestyle Changes (TLC) diet and were assigned to 1 of the following 4 background lipid-lowering therapies for a 4-week stabilization period based upon their screening LDL-C and its distance from the individual's required goal as stipulated by their NCEP ATP III risk category:

1. no drug therapy required - diet alone
2. low dose drug therapy required - diet plus atorvastatin 10 mg orally (PO) once daily (QD)
3. high dose drug therapy required - diet plus atorvastatin 80 mg PO QD
4. maximal drug therapy required - diet plus atorvastatin 80 mg PO QD plus ezetimibe 10 mg PO QD.

If the participant met entry criteria at the end of the lipid stabilization period they were randomized 2:1 to receive evolocumab 420 mg or placebo subcutaneously once a month for 52 weeks in addition to their background therapy.

Arms: arm 1: Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy. arm 2: Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
Interventions: intervention 1: Evolocumab intervention 2: Placebo intervention 3: Atorvastatin intervention 4: Ezetimibe intervention 5: Diet Only
Intervention descriptions: intervention 1: Administered by subcutaneous injection once a month intervention 2: Administered by subcutaneous injection once a month intervention 3: Background lipid lowering therapy: 10 mg or 80 mg atorvastatin orally once daily. intervention 4: Background lipid lowering therapy: ezetimibe 10 mg orally once a day intervention 5: Diet only, no lipid lowering background drug given

Protocol documents:
Clinical trial NCT01445678
Conditions: Complicated Intra-abdominal Infection
Keywords: cIAI
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2011-12-23; Completion date: 2013-10-15
Enrollment: 494 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA-201 Intravenous (IV) infusions (1500mg q8h) and metronidazole (500mg q8h) versus meropenem (1000mg q8h)for the treatment of adults with Complicated Intraabdominal Infections (cIAI).

Detailed description:
Approximately, 500 subjects will be enrolled into this study, randomized 1:1 to receive CXA-201 and metronidazole or comparator (meropenem). Subject participation will require a minimum commitment of 38 days and a maximum of 45 days. An End of Treatment (EOT) visit will occur within 24 hours following the last dose of study drug administration/drug discontinuation. A Test of Cure (TOC)/Safety visit will be conducted 26 to 30 days following the first dose of study drug administration. A Last Follow-up (LFU) visit will be conducted 38 to 45 days after the first dose of study drug.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CXA-201 and metronidazole intervention 2: Meropenem
Intervention descriptions: intervention 1: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days intervention 2: Meropenem IV infusion (1000mg q8h) for 4-14 days

Protocol documents:
Clinical trial NCT01686633
Conditions: Asthma
Keywords: asthma pharmacogenetics adult vilanterol adolescents fluticasone furoate
Sponsor: GlaxoSmithKline
Start date: 2012-09-20; Completion date: 2013-10-15
Enrollment: 1040 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase III, multicenter, randomized, double-blind, stratified, parallel-group study with three active comparators in subjects with moderate to severe persistent asthma. The study consists of a run-in period of 4 weeks, followed by a treatment period of 12 weeks, and a follow up contact period of one week. The total duration of the study is 17 weeks. 990 subjects will be randomized to one of three treatments (FF/VI Inhalation Powder 200/25 mcg once daily in the evening; FF/VI Inhalation Powder 100/25 mcg once daily in the evening; FF 100 Inhalation Powder once daily in the evening) for 12 weeks. In addition, all subjects will be supplied albuterol/salbutamol inhalation aerosol at Visit 1 to use as needed for acute asthma symptoms throughout the entire study. Subjects will attend four on-treatment visits at Weeks 2, 4, 8, and 12 (Visits 4 through 7).

Detailed description:

Arms: arm 1: At Visit 3, eligible subjects for randomization will be stratified according to their baseline FEV1 performed at Visit 3 (\<=65% or \>65%) and randomized to one of the three treatment arms. Subjects in this arm will receive FF/ VI 200/25 mcg once daily in the evening for 84 days. arm 2: At Visit 3, eligible subjects for randomization will be stratified according to their baseline FEV1 performed at Visit 3 (\<=65% or \>65%) and randomized to one of the three treatment arms. Subjects in this arm will receive FF/ VI 100/25 mcg once daily in the evening for 84 days arm 3: At Visit 3, eligible subjects for randomization will be stratified according to their baseline FEV1 performed at Visit 3 (\<=65% or \>65%) and randomized to one of the three treatment arms. Subjects in this arm will receive FF 100 mcg once daily in the evening for 84 days
Interventions: intervention 1: Fluticasone Furoate/ Vilanterol 200/25 mcg intervention 2: Fluticasone Furoate/ Vilanterol 100/25 mcg intervention 3: Fluticasone Furoate 100 mcg
Intervention descriptions: intervention 1: Fluticasone furoate/ vilanterol will be available as 200/25 mcg Novel dry powder inhaler (NDPI) with 30 doses per device and 200/25 mcg per actuation intervention 2: Fluticasone furoate/ vilanterol will be available as 100/25 mcg NDPI with 30 doses per device and 100/25 mcg per actuation intervention 3: Fluticasone furoate will be available as 100 mcg NDPI with 30 doses per device and 100/25 mcg per actuation

Protocol documents:
Clinical trial NCT01311713
Conditions: Solid Tumors
Keywords: cancer tumors PARP
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2011-05-02; Completion date: 2013-10-16
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
CEP-9722 is an inhibitor of poly-adenosine diphosphate (ADP) ribose polymerase -1 and -2 (PARP). The primary purpose of this study is to (Part 1) determine the maximum tolerated dose (MTD) of CEP-9722 administered daily to participants with advanced or metastatic solid tumors, (Part 2) to evaluate the safety and tolerability of that dose, and to investigate whether CEP-9722 has antitumor activity as a single agent.

Detailed description:

Arms: arm 1: Participants will receive Dose 1 of CEP-9722 tablet once daily (QD) orally with a standard meal for up to 6 cycles of 28 days each. arm 2: Participants will receive Dose 1 of CEP-9722 tablets twice daily (BID) orally with a standard meal for up to 6 cycles of 28 days each. arm 3: Participants will receive Dose 2 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each. arm 4: Participants will receive Dose 3 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each. arm 5: Participants will receive Dose 4 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each. arm 6: Participants will receive Dose 5 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each. arm 7: Participants will receive Dose 6 of CEP-9722 tablets BID orally with a standard meal for up to 6 cycles of 28 days each.
Interventions: intervention 1: CEP-9722
Intervention descriptions: intervention 1: CEP-9722 will be administered per dose and schedule specified in the arm description.

Protocol documents:
Clinical trial NCT00799903
Conditions: Atherosclerosis
Keywords: heart disease Lp-PLA2 inhibitor cardiovascular disease coronary heart disease CV risk Atherosclerosis
Sponsor: GlaxoSmithKline
Start date: 2008-12-01; Completion date: 2013-10-17
Enrollment: 15828 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.

Detailed description:
Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard therapy. Following the baseline visit, subjects will be expected to return for clinic visits at 1 month, 3 months, and every 6 months until the end of the study. Average time in the study for an individual subject is expected to be about 3 years.

Arms: arm 1: Single daily oral tablet arm 2: Single daily oral tablet
Interventions: intervention 1: Darapladib intervention 2: Placebo
Intervention descriptions: intervention 1: Lp-PLA2 inhibitor administered in addition to standard therapy intervention 2: Placebo administered in addition to standard therapy

Protocol documents:
Clinical trial NCT01829048
Conditions: Schizophrenia
Keywords: PF-02545920 safety schizophrenia
Sponsor: Pfizer
Start date: 2013-03-06; Completion date: 2013-10-17
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
To evaluate the safety and tolerability of multiple doses of PF 02545920 administered orally to psychiatrically stable subjects with schizophrenia receiving background antipsychotic +/- other adjunctive medication.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-02545920 intervention 2: PF-02545920 intervention 3: PF-02545920 intervention 4: Placebo
Intervention descriptions: intervention 1: 15 mg (2 mg X 2d, 5 mg X 2d, 8 mg X 3 d, then 15 mg) Q12h intervention 2: 15 mg (5 mg X 2d, 10 mg X 2d, then 15 mg) Q12h intervention 3: 15 mg (5 mg BID for 7 days 10 mg BID for 7 days, then 15 mg BID for 4 days) Q12h intervention 4: Placebo Q12h

Protocol documents:
Clinical trial NCT01916226
Conditions: Rhinitis, Allergic, Perennial and Seasonal
Keywords: cetirizine seasonal allergic rhinitis Quality of Life fluticasone propionate nasal spray
Sponsor: GlaxoSmithKline
Start date: 2013-08-01; Completion date: 2013-10-17
Enrollment: 682 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase IV investigational trial is being conducted to evaluate the efficacy of a 2-week treatment of fluticasone propionate nasal spray (FPNS) vs. cetirizine on allergic nasal and ocular symptoms and quality of life in adult subjects with SAR. It is hypothesized that FPNS provides greater nasal symptom relief than cetirizine. The primary measure used to test this hypothesis is the change from baseline over two weeks in reflective total nasal symptom score (rTNSS) compared between FPNS and cetirizine. Approximately 648 subjects will be randomized into a 1:1:1:1 ratio of treatment allocation across approximately twenty-five to thirty-five sites in the US during the 2013 fall allergy season. All subjects will be outpatients. The total duration of study will be approximately 21 days including 7 days of screening period, and 14 days of treatment period.

Detailed description:

Arms: arm 1: Subject will receive two sprays (200 mcg per day)of FP into each nostril once daily (OD) every morning for 14 days arm 2: Subject will receive two sprays of FP placebo into each nostril OD every morning for 14 days arm 3: Subject will receive Cetirizine capsule by mouth OD in the morning for 14 days arm 4: Subject will receive Cetirizine Placebo capsule by mouth OD in the morning for 14 days
Interventions: intervention 1: FPNS intervention 2: FPNS Placebo intervention 3: Cetirizine intervention 4: Cetirizine Placebo
Intervention descriptions: intervention 1: Bottled, 16 gm net fill weight for 120 metered sprays with unit dose strength of 50 mcg per spray. intervention 2: Bottled placebo nasal spray (vehicle for Fluticasone propionate aqueous nasal spray), 16 gm net fill weight for 120 metered sprays. intervention 3: Over-encapsulated Cetirizine tablet with unit dose strength of 10 mg in High Density Poly Ethylene Bottles (20 count per bottle). intervention 4: Over-encapsulated Cetirizine matching tablet High Density Poly Ethylene Bottles (20 count per bottle).

Protocol documents:
Clinical trial NCT04531540
Conditions: Hypersensitivity
Sponsor: Bayer
Start date: 2013-09-09; Completion date: 2013-10-18
Enrollment: 225 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this study researcher want to learn more about possible skin reactions such after repeated application of an antifungal cream containing Trolamine. They are especially interested in skin irritations or allergic skin reactions. The study plans to enroll about 225 female or male participants with the age 18 - 79 years. The antifungal test cream will be applied on the back between the shoulder blades of the participants and covered by a special dressing patch. This will be repeated 3 times a week for the first 3 weeks of this study applying the cream on the same area of the back. At each visit the skin will be investigated for redness, dryness and other reactions. After a rest period of two weeks the test cream will be applied on the same skin area as before and on a second new skin area nearby. After 2 and 4 days the two skin areas will again be investigated for redness, dryness and other reactions.

Detailed description:

Arms: arm 1: During the Induction Phase, participants received 0.2 g Butenafine HCl 1% covered by an occlusive patch on the upper back skin test site three times a week for a total of 9 applications. Prior to each patch application and after the last patch removal, the test sites were evaluated for gross changes according to the Erythemal Scoring Scale and if necessary the Additional Scoring system. After 14 days of Rest Phase, on the first day of Challenge Phase, participants received same procedure on original Induction Phase test site and on a virgin test site. The patches were removed and the sites scored 48 hours after application and scored again at 96 hours after application. The test sites were evaluated using the Induction Phase scoring system.
Interventions: intervention 1: Butenafine HCl 1% (BAY1896425)
Intervention descriptions: intervention 1: Approximately 0.2 g of cream containing butenafine HCl 1% were applied to the upper back skin.

Protocol documents:
Clinical trial NCT01507545
Conditions: Metastatic Colorectal Cancer Colorectal Cancer
Keywords: mCRC chemorefractory metastatic colorectal cancer
Sponsor: Morphotek
Start date: 2012-03-27; Completion date: 2013-10-20
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether therapy with MORAb-004 is effective and safe in the treatment of metastatic, colorectal cancer.

Detailed description:
Tumor endothelial marker-1 also referred to as TEM-1 is expressed in the supportive tissue, as well as, on the cells within the tumor. TEM-1, which is a cell surface glycoprotein, and is expressed in the stromal compartment (cells) of nearly all human tumors. In preclinical studies, it has been shown that TEM-1 plays a key role in tumor growth and the vascularization of tumors. There is evidence suggesting an association between the level of TEM-1, 7, 7R, 8 in relation to lymph node involvement and disease progression. MORAb-004 is a humanized immunoglobulin G (IgG1/κ) antibody directed against endosialin/TEM-1. Nonclinical pharmacological studies showed that MORAb-004 has the ability to block specific TEM-1 receptor-ligand interactions. Immunohistochemistry studies of human tumor biopsy samples demonstrate TEM-1 expression and MORAb-004 binding to tumor stromal cells, in particular mural cell compartment of neovessels and cancer-associated fibroblasts. All of which suggests a potential effective treatment. Researchers hypothesize that an antibody therapy that binds to TEM-1 may be efficacious in the treatment of metastatic, colorectal cancer. This clinical study is a proof of concept study to see if an anti-TEM-1 agent is safe and effective in the treatment of metastatic, colorectal cancer.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MORAb-004 intervention 2: Placebo intervention 3: Best supportive care
Intervention descriptions: intervention 1: MORAb-004 8mg per kg IV once a week intervention 2: Placebo - normal saline IV once a week intervention 3: Best supportive care to improve quality of life

Protocol documents: