ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01673620
Conditions: Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2012-07-04; Completion date: 2012-10-10
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and tolerability of montelukast 10 mg/loratadine 10 mg versus placebo in Mexican participants with allergic rhinitis.

Detailed description:

Arms: arm 1: Montelukast 10 mg/loratadine 10 mg combination tablet administered orally once daily for 2 weeks arm 2: Matching placebo tablet administered orally once daily for 2 weeks
Interventions: intervention 1: Montelukast 10 mg/loratadine 10 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Montelukast 10 mg/loratadine 10 mg tablet administered once daily intervention 2: Matching placebo tablet administered once daily

Protocol documents:
Clinical trial NCT00358215
Conditions: Heart Failure Anemia Cardiovascular Disease Ventricular Dysfunction Congestive Heart Failure
Keywords: Survival study morbidity and mortality heart failure hospitalization all-cause death patient-reported outcomes Kansas City Cardiomyopathy questionnaire anemia treatment
Sponsor: Amgen
Start date: 2006-06-01; Completion date: 2012-10-11
Enrollment: 2278 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia.

Detailed description:
Several epidemiological studies have demonstrated an association between HF and anemia and correlation of increased risk for mortality and hospitalization with low hemoglobin in patients with HF. Earlier single-center interventional studies suggest that meaningful clinical benefits may be achieved by raising hemoglobin concentration in patients with symptomatic HF and anemia. Data from Amgen's completed phase 2 multi-center studies support this hypothesis and show that darbepoetin alfa is well tolerated in patients with symptomatic left ventricular systolic dysfunction and anemia and effectively raises hemoglobin. The pivotal phase 3 Study 20050222 RED-HF Trial is evaluating the effect of treatment with darbepoetin alfa on the composite risk of all-cause mortality or hospitalization for worsening HF in patients with symptomatic left ventricular systolic dysfunction and anemia. This study also evaluates the effect of darbepoetin alfa treatment on all-cause death, on cardiovascular death or hospitalization for worsening HF, and on patient-reported quality-of-life outcomes.

Arms: arm 1: Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL. arm 2: Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
Interventions: intervention 1: Darbepoetin alfa intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Placebo subcutaneous injection

Protocol documents:
Clinical trial NCT00823979
Conditions: HIV-1
Keywords: HIV-1 NNRTI Treatment Experienced may have Protease inhibitor experience
Sponsor: Pfizer
Start date: 2009-03-25; Completion date: 2012-10-18
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 96 week study to determine if UK- 453,061 in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor is as efficacious, safe and tolerable as etravirine in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor in HIV-1 infected patients who have been previously treated with antiretroviral drugs and have NNRTI resistance mutations.

Detailed description:
The trial was terminated on 12 April, 2012 due to lack of efficacy at the Week 24 analysis. The decision to terminate the trial was not based on any safety concerns.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: UK-453,061 Dose 1 intervention 2: UK-453,061 Dose 2 intervention 3: Etravirine
Intervention descriptions: intervention 1: UK 453,061 750 mg QD + one optimized NRTI + darunavir/ritonavir. intervention 2: UK 453,061 1000 mg QD + one optimized NRTI + darunavir/ritonavir. intervention 3: Etravirine 200 mg BID + one optimized NRTI + darunavir/ritonavir.

Protocol documents:
Clinical trial NCT01691482
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Start date: 2012-07-23; Completion date: 2012-10-22
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to assess the daily variation in bronchodilator response to an inhaled short acting beta2-agonist (albuterol/salbutamol) and an inhaled short acting anticholinergic (ipratropium) individually and when used in combination in subjects with COPD.

Detailed description:
Beta2-agonist and anticholinergics are a principle component of the pharmacologic management of chronic obstructive pulmonary disease COPD. It has been demonstrated that the combination of a short acting beta2-agonist and a short acting anticholinergic yields greater efficacy as measured by FEV1 when compared with the response to the individual short acting bronchodilators. However, daily bronchial response to these agents is poorly understood. It is also poorly understood how the variation in magnitude of the response to the individual agents and how the variation in response for one agent coincides with the variation in response to the other agent. This study will seek to define the pattern of response of each individual agent and the relationship between them. The study will also explore if the combination of the two agents leads to less variation in response compared to the individual agents. This is a randomized, open label, two period cross-over study. Eligible subjects will be randomized to a sequence of either albuterol/salbutamol via metered-dose inhaler (MDI) followed by ipratropium via MDI or the same dose of each bronchodilator given in the opposite order. Each study period will consist of 10 clinic visits to be conducted over 10 to 14 days.

Arms: arm 1: Subjects will recieve daily albuterol/salbutamol followed by ipratropium which will be adminstered one hour after adminstration of albuterol/salbutamol arm 2: Subjects will recieve daily ipratropium followed by albuterol/salbutamol which will be adminstered one hour after adminstration of ipratropium
Interventions: intervention 1: Albuterol/salbutamol intervention 2: Ipratropium
Intervention descriptions: intervention 1: Albuterol/salbutamol (daily) intervention 2: Ipratropium (daily)

Protocol documents:
Clinical trial NCT01085097
Conditions: Lupus Nephritis
Keywords: Systemic Lupus Erythematosus (SLE) Lupus Nephritis Laquinimod
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2010-09-01; Completion date: 2012-10-24
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules in active lupus nephritis participants. This study will assess Laquinimod doses of 0.5 milligrams (mg)/day and 1 mg/day in combination with standard of care treatment (mycophenolate mofetil \[MMF\] and corticosteroids). Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.

Detailed description:

Arms: arm 1: Participants will receive 2 capsules of placebo matching to laquinimod orally once daily (QD) for 24 weeks, MMF 500 mg tablet orally twice daily (BID) for the first week then 1 gram (g) BID from Week 2 to Week 28, and MP 500 mg/day intravenously (IV) from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28. arm 2: Participants will receive 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matching to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28. arm 3: Participants will receive 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
Interventions: intervention 1: Laquinimod intervention 2: Mycophenolate Mofetil intervention 3: Prednisolone/Prednisone intervention 4: Placebo intervention 5: Methylprednisolone
Intervention descriptions: intervention 1: Laquinimod will be administered per dose and schedule specified in the arm description. intervention 2: Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description. intervention 3: Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description. intervention 4: Placebo matching to laquinimod will be administered per schedule specified in the arm description. intervention 5: Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.

Protocol documents:
Clinical trial NCT01214915
Conditions: Essential Thrombocythemia (ET)
Sponsor: Shire
Start date: 2010-10-27; Completion date: 2012-10-24
Enrollment: 53 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate how effective and safe SPD422 (Anagrelide Hydrochloride) is in Japanese subjects, diagnosed with Essential Thrombocythemia, who's previously treatment has either not been effective or has caused unacceptable adverse reactions. The study will aim to show that platelet counts can be safely reduced in treated patients to below 600 x 10\^9/L after a minimum of three months treatment. To demonstrate an positive effect platelet levels will need to remain below 600 x 10\^9/L for at least 4 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Anagrelide Hydrochloride
Intervention descriptions: intervention 1: Subjects will be started at 1.0 mg per day and titrated as necessary.

Protocol documents:
Clinical trial NCT01225731
Conditions: Psoriasis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-10-25; Completion date: 2012-10-24
Enrollment: 355 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a response-driven study of tildrakuzumab for the treatment of moderate to severe chronic plaque psoriasis. The primary study hypothesis is that one or more doses of tildrakizumab will be superior to placebo for the treatment of psoriasis.

Detailed description:
Each participant will be enrolled in the trial for approximately 72-76 weeks. Each participant will receive assigned treatment at Weeks 0 and 4 in Part I. At Week 16, the dosage of treatment the patient is assigned to may be adjusted based on the Psoriasis Area and Severity Index (PASI) 75 response (responder vs non-responder). Participants will receive study medication once every 12 weeks during Part 2 (Weeks 16 to 52); no participants will receive placebo in Part 2. Part 3 is an observational period and each subject will continue to be monitored on a monthly basis through Week 72. Subjects will not receive any study medication during Part 3.

Arms: arm 1: Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4 arm 2: Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4 arm 3: Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4 arm 4: Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4 arm 5: Participants receive placebo, SC, at Weeks 0 and 4 arm 6: Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks arm 7: Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks arm 8: Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks arm 9: Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks arm 10: Participants are followed for up to 20 weeks after the last dose of study drug. arm 11: Participants are followed for up to 20 weeks after the last dose of study drug. arm 12: Participants are followed for up to 20 weeks after the last dose of study drug. arm 13: Participants are followed for up to 20 weeks after the last dose of study drug. arm 14: Participants are followed for up to 20 weeks after the last dose of study drug.
Interventions: intervention 1: tildrakizumab intervention 2: Placebo
Intervention descriptions: intervention 1: SC administration of tildrakizumab at assigned dose intervention 2: SC administration of Placebo

Protocol documents:
Clinical trial NCT01392469
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension Pulmonary Vascular Resistance Imatinib Bosentan Sildenafil
Sponsor: Novartis Pharmaceuticals
Start date: 2011-04-20; Completion date: 2012-10-25
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to investigate the effects of QTI571 (imatinib) on pharmacokinetics of bosentan and sildenafil at steady state when co-administered to participants with pulmonary arterial hypertension.

Detailed description:

Arms: arm 1: Participants received treatment with bosentan 125 milligrams (mg) twice daily and sildenafil thrice daily for 8 days in treatment period 1. Participants were on the same sildenafil dose level (20, 40, 50 or 60 mg) they had been at study entry which was well tolerated in conjunction with bosentan. Following treatment period 1, the participants received concomitant treatment of oral imatinib 200 mg daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 2. Following treatment period 2, the participants received concomitant treatment of oral imatinib 400 mg daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 3.
Interventions: intervention 1: Imatinib intervention 2: Sildenafil intervention 3: Bosentan
Intervention descriptions: intervention 1: Film coated tablets, oral administration intervention 2: Oral Administration intervention 3: Oral Administration

Protocol documents:
Clinical trial NCT00608062
Conditions: Arterial Stiffening Aging Menopause
Keywords: endothelial function women female estrogen deficiency sex hormones adiposity oxidative stress antioxidants
Sponsor: University of Colorado, Denver
Start date: 2007-03-01; Completion date: 2012-10-25
Enrollment: 155 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out why women's arteries stiffen as they go through menopause, and how this is affected by estrogen loss. We believe that arteries stiffen with the loss of estrogen because of "oxidative stress," the production of molecules that can damage cells and tissues in the body, and because the arteries lose their ability to expand, or dilate.

Detailed description:
As women get older and go through menopause, estradiol levels decrease. Also with aging, the arteries that are located around the heart get stiffer. Over time this increase in arterial stiffness can lead to a number of health problems such as high blood pressure and heart disease. In this study we want to find out if a short-term drop in estrogen levels in premenopausal and perimenopausal women can cause arteries to become stiffer, and why this happens. Additionally, in postmenopausal women, we want to find out if a short-term increase in estrogen levels causes their arteries to become more flexible (less stiff).

Arterial health (i.e., stiffness) will be examined in premenopausal, perimenopausal and postmenopausal women before and after they are given a drug called Ganirelix™ (for 7 days), which will markedly lower their reproductive hormones. After the first 4 days of taking Ganirelix™, the women will be randomly placed into 1 of 2 treatment groups to take either estrogen (0.075 mg/d skin patch) replacement or placebo for the rest of the Ganirelix treatment. This is to increase estrogen levels back to the normal level. After having the patch on for 4 days, arterial health will be examined again.

Pre-specified Outcome Measures were divided into unit-of-measurement specific Outcome Measure tables for the purposes of results reporting to ClinicalTrials.gov

Arms: arm 1: Premenopausal - GnRHant plus estradiol arm 2: Premenopausal - GnRHant plus placebo arm 3: Perimenopausal (early) - GnRHant plus estradiol arm 4: Perimenopausal (early) - GnRHant plus placebo arm 5: Perimenopausal (late) - GnRHant plus estradiol arm 6: Perimenopausal (late) - GnRHant plus placebo arm 7: Postmenopausal - GnRHant plus estradiol arm 8: Postmenopausal - GnRHant plus placebo
Interventions: intervention 1: GnRHant - Ganirelix acetate intervention 2: Transdermal estradiol patch intervention 3: Transdermal placebo patch
Intervention descriptions: intervention 1: 1 subcutaneous injection at 0.5 mg then daily injections of 0.25 mg for 6 days (total of 7 days of injections); testing will occur on injection day 4 and day 7 intervention 2: 0.075mg/d starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7) intervention 3: Starting on day 4 of the injections following testing time point two; continue for 3 days and retest (day 7)

Protocol documents:
Clinical trial NCT00986440
Conditions: Colorectal Cancer
Sponsor: Daiichi Sankyo
Start date: 2009-07-31; Completion date: 2012-10-29
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Monotherapy treatment with CS-7017 to assess progression-free-survival (PFS) of subjects who achieved an objective response of Disease Control on first line therapy with Folinic acid (leucovorin), Fluorouracil (5-FU), Oxaliplatin (Eloxatin) known as FOLFOX; or Folinic acid (leucovorin), Fluorouracil (5-FU), irinotecan (Camptosar) known as FOLFIRI.

Detailed description:

Arms: arm 1: None arm 2: Placebo matching CS-7017
Interventions: intervention 1: CS-7017 intervention 2: Placebo
Intervention descriptions: intervention 1: CS-7017 intervention 2: Placebo

Protocol documents:
Clinical trial NCT00569946
Conditions: Carcinoma, Renal Cell
Keywords: AG-013736 RCC Phase 2
Sponsor: Pfizer
Start date: 2007-12-12; Completion date: 2012-10-30
Enrollment: 64 participants; Allocation: ; Intervention model: 

Brief summary:
To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC)

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: AG-013736
Intervention descriptions: intervention 1: AG-013736 5 mg BID will be administered orally on continuous schedule. Cycle length is 28 days. If the drug is well tolerated at 5 mg BID, the dose of AG-013736 may be titrated to 7 mg BID and then to a maximum of 10 mg BID.

Number of cycles: until progression or unacceptable toxicity develops.

Protocol documents:
Clinical trial NCT00867087
Conditions: Lymphoma, B-Cell
Keywords: Diffuse large b-cell lymphoma inotuzumab ozogamicin autologous stem cell transplant
Sponsor: Pfizer
Start date: 2009-06-08; Completion date: 2012-10-31
Enrollment: 64 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma.

Detailed description:

Arms: arm 1: Inotuzumab ozogamicin, in combination with rituximab, will be administered to patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma prior to an autologous stem cell transplant (aSCT).
Interventions: intervention 1: inotuzumab ozogamicin (CMC-544) intervention 2: rituximab
Intervention descriptions: intervention 1: 1.8 mg/m\^2 every 21 days by intravenous infusion, 3 to 6 doses intervention 2: 375 mg/m\^2 two days before cycle 1 by intravenous infusion; 375 mg/m\^2 every 21 days by intravenous infusion, 3 to 6 doses

Protocol documents:
Clinical trial NCT01189890
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, Hemoglobin A1C, glucagon-like peptide 1 (GLP-1), gastric inhibitory polypeptide (GIP), dipeptidyl peptidase 4 inhibitor (DPP-4)
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-08-16; Completion date: 2012-10-31
Enrollment: 480 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to determine if sitagliptin treatment is not inferior to that of glimepiride as measured by the change in baseline hemoglobin A1C (HbA1C) after 30 weeks of treatment, and if sitagliptin treatment results in a lower incidence of symptomatic hypoglycemia compared to that of glimepiride. The study will also evaluate if sitagliptin treatment, compared to glimepiride results in improvements in fasting plasma glucose (FPG) levels, and plasma lipid levels after 30 weeks of treatment. Participants will be randomized to either sitagliptin or glimepiride treatment after eligibility for study participation is determined during screening and washout study phases. Participants and study staff will not know to which treatment group they have been randomized (double-blind design). The duration of study participation will be up to 40 weeks (with 9 clinic visits). This will include a screening phase (Visit 1 to Visit 2) of 2 weeks maximum; a 6-week (Visits 2 to 3) oral antihyperglycemic agent (AHA) wash-out phase (for those who have been taking a AHA prior to the study); a placebo run-in phase (Visits 3 to 4), followed by up to 30 weeks of treatment with study medication.

Detailed description:
The dose of sitagliptin will be 100 mg once daily (QD) or 50 mg QD based on the participant's estimated glomerular filtration rate (eGFR). The starting dose of glimepiride (1 mg QD) may be up-titrated as needed to optimize glycemic control over the first 18 weeks to a maximum dose of 6 mg/day, after which the dose will not be increased for the rest of the study (down-titration to avoid or control hypoglycemia is allowed).

Arms: arm 1: Sitagliptin phosphate 100 mg or 50 mg once daily (QD) arm 2: Glimepiride 1-6 mg QD
Interventions: intervention 1: sitagliptin phosphate intervention 2: Glimepiride intervention 3: Placebo to Sitagliptin intervention 4: Placebo to Glimepiride
Intervention descriptions: intervention 1: Sitagliptin tablets, orally, at a dose of 100 mg or 50 mg QD for 30 weeks. The dose level to be administered will depend on the participant's estimated glomerular filtration rate (eGFR), calculated at Visit 3 and may be adjusted as medically indicated during the study. intervention 2: Glimepiride tablets, orally, starting at a dose of 1 mg QD, which may be gradually increased, as needed, to maximum dose of 6 mg QD for 30 weeks. The dose may also be decreased as medically indicated during the study. intervention 3: Matching placebo tablets to sitagliptin to allow for blinding. intervention 4: Matching placebo tablets to glimepiride to allow for blinding.

Protocol documents: