ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00369928
Conditions: Rheumatoid Arthritis
Sponsor: Procter and Gamble
Start date: 2006-08-01; Completion date: 2008-01-01
Enrollment: 254 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. After the washout period, patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after the last treatment visit. The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.

Detailed description:
The study will be conducted in North America and Europe at approximately 50 to 60 sites. Approximately 270 patients will be randomized, of which 189 are expected to complete the study.

The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. The washout period will be 4 weeks for sulfasalazine, hydroxychloroquine, azathioprine, D-penicillamine, etanercept, and anakinra, 8 weeks for gold, infliximab, and adalimumab, and 12 weeks for abatacept.

After the washout period, the patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits (Weeks 1, 2, 4, 6, 8, and 12) and a follow-up visit 4 weeks after the last treatment visit (Week 16). Patients will not initiate new therapies until after the 4-week follow-up is completed. Liver function tests will be evaluated at every visit.

The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.

Arms: arm 1: Placebo, oral dose, BID arm 2: 25 mg BID, of oral PG-760564 arm 3: 100 mg BID, of oral PG-760564
Interventions: intervention 1: PG-760564 intervention 2: Placebo dose intervention 3: PG-760564
Intervention descriptions: intervention 1: 100 mg BID, of oral PG-760564 intervention 2: placebo, BID, oral for 12 weeks intervention 3: 25 mg BID, of oral PG-760564

Protocol documents:
Clinical trial NCT00373360
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension PAH Remodulin treprostinil Quality of Life Rapid Switch
Sponsor: United Therapeutics
Start date: 2006-09-01; Completion date: 2008-01-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.

Detailed description:
Pulmonary arterial hypertension (PAH), which is defined as an elevation in pulmonary arterial pressure and pulmonary vascular resistance, is a severe hemodynamic abnormality common to a variety of diseases and syndromes. Elevation in pulmonary arterial pressure causes an increase in right ventricular afterload, impairing right ventricular function and ultimately leading to inactivity and death. The goal of PAH treatment is to lengthen survival time, to ameliorate symptoms of PAH and to improve health related quality of life (HRQOL).

Remodulin® (treprostinil sodium), a stable analogue of prostacyclin, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo. Recently, Remodulin received FDA approval for intravenous therapy based upon bioequivalence of the IV and SC routes of administration. Remodulin is more chemically stable than epoprostenol and may offer potential safety and convenience advantages compared to intravenous epoprostenol that may impact Health Related Quality of Life (HRQOL) and/or patient satisfaction. Unlike epoprostenol, Remodulin does not need to be mixed daily and is stable at room temperature eliminating the need for ice packs. Furthermore, since Remodulin remains in the body longer than epoprostenol (4 hrs instead of less than 5 minutes) there is less risk of cardiovascular collapse from a sudden interruption of infusion, such as a line clog. In an open-label study in Europe, patients who were using a type of portable medication pump called the CADD Legacy pump were rapidly switched from Flolan to Remodulin with no serious side effects. This study will examine effects of switching from therapy with epoprostenol or Flolan to IV Remodulin and compare changes in HRQOL and treatment satisfaction before and after rapid switch from epoprostenol to Remodulin in patients with pulmonary hypertension using the CADD legacy pump.

Participation in this study will last approximately 10 weeks. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, exercise tests and patient questionnaires. Participants will have 4 visits during the study and will spend at least 1 night in the hospital.

Arms: arm 1: None
Interventions: intervention 1: treprostinil sodium
Intervention descriptions: intervention 1: rapid switch from intravenous epoprostinol to intravenous remodulin on the CADD ambulatory pump

Protocol documents:
Clinical trial NCT00374231
Conditions: Liver Transplantation
Keywords: Liver Transplant Corticosteroid withdrawal Tacrolimus CellCept MMF Mycophenolate mofetil
Sponsor: University of Cincinnati
Start date: 2002-10-01; Completion date: 2008-01-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppressant therapy.

Detailed description:
To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppression therapy.

Arms: arm 1: All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short course of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.
Interventions: intervention 1: tacrolimus intervention 2: mycophenolate mofetil intervention 3: Prednisone
Intervention descriptions: intervention 1: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. intervention 2: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. intervention 3: Prednisone is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.

Protocol documents:
Clinical trial NCT00381485
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2006-07-01; Completion date: 2008-01-01
Enrollment: 834 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind treatment period, subjects will receive open-label MF MDI 400 mcg BID for 2 to 3 weeks during the run-in period. Efficacy will be measured by the area under the curve from 0 to 12 hours \[AUC\](0-12 hr) of the change from Baseline to the Week 12 Endpoint in forced expiratory volume in one second (FEV1).

Detailed description:

Arms: arm 1: Mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily

Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period arm 2: Mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily

Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period arm 3: Mometasone Furoate 400 mcg taken twice daily

Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period
Interventions: intervention 1: Mometasone furoate/formoterol (MF/F) combination intervention 2: Mometasone furoate/formoterol (MF/F) combination intervention 3: Mometasone furoate MDI (MF MDI)
Intervention descriptions: intervention 1: MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks intervention 2: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks intervention 3: MF 400 mcg via metered dose inhaler twice daily for 12 weeks

Protocol documents:
Clinical trial NCT00390780
Conditions: HIV Infections
Keywords: Miconazole Lauriad Oropharyngeal candidiasis HIV patients Mycology Clinical picture of Oropharyngeal candidiasis Candida culture positive Treatment Experienced
Sponsor: Valerio Therapeutics
Start date: 2006-07-01; Completion date: 2008-01-01
Enrollment: 578 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days of treatment (at the test of cure visit, at Day 17-19).

Detailed description:

Arms: arm 1: Clotrimazole troches, 10 mg, 5 times per day for 14 days arm 2: Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Interventions: intervention 1: miconazole Lauriad intervention 2: Clotrimazole
Intervention descriptions: intervention 1: 50 mg buccal tablet once a day for 14 days intervention 2: 10mg troches administered Five Times a Day for 14 days

Protocol documents:
Clinical trial NCT00391976
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis
Sponsor: Novartis
Start date: 2003-11-01; Completion date: 2008-01-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed time to recurrence of infection with Pseudomonas aeruginosa following treatment of the initial infection with tobramycin nebuliser solution. The safety profile of the initial tobramycin treatment was assessed during the first 3 months of the study and patients were followed until the end of the study, month 27.

Detailed description:
This was a multi-center, open-label, two-arm, randomized study. All patients diagnosed with CF and who fulfilled the criteria for early infection with P. aeruginosa initially received tobramycin 300 mg twice a day for 28 days. At the end of the 28-day treatment period, patients who met the inclusion criteria and none of the additional exclusion criteria were randomized in a 1:1 ratio to either receive an additional 28 days of treatment with tobramycin 300 mg twice a day (56-day group) or to stop study medication (28-day group).

All randomized patients had regular study visits until a positive P. aeruginosa sample was obtained. Once P. aeruginosa had recurred, the patient entered a follow-up phase where minimal information was collected for 27 months. During the follow-up phase, patients were treated according to their physicians' discretion.

Patients who started treatment with tobramycin but were not randomized (i.e. due to a positive antibody test) and followed up during routine clinic visits. They were allowed to continue their 28-day treatment period and afterwards be treated according to their physicians' discretion.

Arms: arm 1: Patients inhaled tobramycin 300 mg bis in die (bid, twice a day) for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart. arm 2: Patients inhaled tobramycin 300 mg bis in die (bid, twice a day) for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
Interventions: intervention 1: Tobramycin solution for inhalation 300 mg
Intervention descriptions: intervention 1: Tobramycin solution for inhalation was supplied in 5 mL liquid-filled low-density polyethylene ampoules containing 300 mg tobramycin. Patients used a nebulizer to inhale the contents of the ampoules.

Protocol documents:
Clinical trial NCT00400439
Conditions: Coronary Heart Disease
Sponsor: Hoffmann-La Roche
Start date: 2007-01-01; Completion date: 2008-01-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6 months post study NC19453, and the target sample size is approximately 100 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: dalcetrapib (RO4607381) intervention 2: placebo
Intervention descriptions: intervention 1: 900mg po daily for 24 weeks intervention 2: po daily for 24 weeks

Protocol documents:
Clinical trial NCT00412841
Conditions: Avascular Necrosis
Keywords: Avascular Necrosis Lipitor SLE
Sponsor: NYU Langone Health
Start date: 2002-11-01; Completion date: 2008-01-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study uses the cholesterol lowering drug atorvastatin, also known as lipitor, to show reduction of avascular necrosis in steroid treated lupus patients. Avascular necrosis is a disease resulting from the loss of blood supply to the bones which can cause the bone to collapse. The collapse of bone may require a surgical replacement of the joint and can be disabling for life. Avascular necrosis is presently not preventable but research has shown that lipid lowering drugs such as lipitor can reduce or prevent avascular necrosis in animals. We therefore hypothesize that lipitor will reduce the incidence of avascular necrosis in lupus patients taking high dose steroids.

Detailed description:
If you have started on prednisone 30mg or greater and expect to be on it for greater than two weeks you may be a candidate for the study. Also, you would need to be enrolled in the study within three days of starting prednisone. If you are eligible you will receive lipitor 40mg per day or pills which look exactly like lipitor but do not contain any medication (called placebo). During the time of the study, you will not know if you are taking lipitor or the placebo. The period of time that you will receive lipitor or placebo is 9 months and you must be willing to return for 5 follow up visits during this time which include blood tests, physical exams and 3 MRI studies of the hips, knees and ankles.

Arms: arm 1: Atorvastatin 40mg arm 2: Tablets identical to atorvastatin 40mg
Interventions: intervention 1: Atorvastatin intervention 2: MRI, Venipuncture intervention 3: Placebo
Intervention descriptions: intervention 1: Atorvastatin 40mg vs placebo 40mg daily intervention 2: MRIs done baseline, four and nine months intervention 3: Tablets identical to atorvastatin 40mg

Protocol documents:
Clinical trial NCT00441441
Conditions: Asthma
Keywords: asthma fluticasone propionate children fluticasone propionate/salmeterol
Sponsor: GlaxoSmithKline
Start date: 2007-02-01; Completion date: 2008-01-01
Enrollment: 351 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed.

Detailed description:

Arms: arm 1: Fluticasone propionate/salmeterol 100/50 HFA (2 inhalations of 50/25mcg), twice daily (strengths are ex-valve) and a placebo HFA inhaler matching the fluticasone propionate 100mcg HFA inhaler (2 inhalations) twice daily arm 2: Fluticasone propionate 100mcg HFA (2 inhalations of 50mcg), twice daily (strengths are ex-valve) and a placebo HFA inhaler matching the fluticasone propionate/salmeterol 100/50 HFA inhaler (2 inhalations ) twice daily
Interventions: intervention 1: fluticasone propionate intervention 2: fluticasone propionate/salmeterol
Intervention descriptions: intervention 1: fluticasone propionate 100mcg HFA intervention 2: fluticasone propionate/salmeterol 100/50mcg HFA

Protocol documents:
Clinical trial NCT00442416
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2007-02-01; Completion date: 2008-01-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomized either to receive monthly sc injections of Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 380 individuals.

Detailed description:

Arms: arm 1: Eligible participants will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) will be based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses will be adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization will continue to do so. arm 2: Eligible participants will be administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and will be followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization will continue to do so.
Interventions: intervention 1: Epoetin alfa intervention 2: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: As prescribed, SC intervention 2: 120-360 micrograms SC monthly, starting dose

Protocol documents:
Clinical trial NCT00445705
Conditions: Fibromyalgia
Sponsor: Allergan
Start date: 2007-03-01; Completion date: 2008-01-01
Enrollment: 211 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2 parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 440 pts and dose with either 20, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.

Detailed description:

Arms: arm 1: Part A: Placebo every 12 hours for 4 weeks arm 2: Part A: 3 mg AGN 203818 every 12 hours for 4 weeks arm 3: Part A: 20 mg AGN 203818 every 12 hours for 4 weeks arm 4: Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
Interventions: intervention 1: placebo intervention 2: AGN 203818 intervention 3: AGN 203818 intervention 4: AGN 203818
Intervention descriptions: intervention 1: Part A: Placebo every 12 hours for 4 weeks intervention 2: Part A: AGN 203818 3 mg every 12 hours for 4 weeks intervention 3: Part A: AGN 203818 20 mg every 12 hours for 4 weeks intervention 4: Part A: AGN 203818 60 mg every 12 hours for 4 weeks

Protocol documents:
Clinical trial NCT00450177
Conditions: Anemic, Critically Ill Patients
Keywords: iron critical illness anemia infection
Sponsor: Weill Medical College of Cornell University
Start date: 2006-01-01; Completion date: 2008-01-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy of enteral iron supplementation for improving anemia, decreasing the risk of blood transfusion, and decreasing mortality in patients who are hospitalized in the intensive care unit. This study will also address any relationship between enteral iron supplementation and risk of infection.

Detailed description:
Critical illness is characterized by the anemia of inflammation, which is partially caused by sequestration of iron from bone marrow sites of erythropoiesis into storage within the reticuloendothelial system as ferritin. Also the majority of critically ill patients are hypoferremia, the efficacy of iron supplementation remains unknown. Furthermore, several retrospective studies have found an association between iron overload and infection. However, the relative risk/benefit profile of enteral iron supplementation with respect to infection has not been studied. The purpose of this study is to evaluate the efficacy of enteral iron supplementation in critically ill patients. The hypothesis is that enteral iron supplementation will result in both an improved hematocrit and a decreased need for blood transfusion, without increasing the risk of infection.

Arms: arm 1: Ferrous sulfate 325 mg either by capsule or oral solution three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first. arm 2: Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
Interventions: intervention 1: Ferrous Sulfate intervention 2: Placebo Oral Tablet
Intervention descriptions: intervention 1: Iron group intervention 2: Placebo group

Protocol documents:
Clinical trial NCT00452400
Conditions: Pulmonary Disease, Chronic Obstructive Asthma
Sponsor: Boehringer Ingelheim
Start date: 2007-03-01; Completion date: 2008-01-01
Enrollment: 409 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount of the medication found in your blood).

Detailed description:

Interventions: intervention 1: BI 1744CL
Intervention descriptions: intervention 1: None

Protocol documents: