ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00412971
Conditions: Bladder Cancer
Keywords: Recurrence of bladder cancer Fluorescence cystoscopy
Sponsor: Photocure
Start date: 2005-04-01; Completion date: 2008-10-01
Enrollment: 233 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.

The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix assisted TURB compared to standard white light TURB.

Detailed description:
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.

Patients will be followed 4, 8 and 12 months after the initial TURB. This follow-up regimen is according to standard clinical practice in Denmark.

Recurrence of non-invasive bladder cancer is frequent, and this study is designed to investigate whether Hexvix assisted TURB can reduce the early recurrence compared to standard TURB

Arms: arm 1: None arm 2: Standard White light cystoscopy
Interventions: intervention 1: Hexvix intervention 2: Standard white light cystoscopy
Intervention descriptions: intervention 1: Single installation, TURB intervention 2: None

Protocol documents:
Clinical trial NCT00413894
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2007-03-01; Completion date: 2008-10-01
Enrollment: 424 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa

Protocol documents:
Clinical trial NCT00424593
Conditions: Back Pain Without Radiation
Sponsor: Eli Lilly and Company
Start date: 2007-01-01; Completion date: 2008-10-01
Enrollment: 236 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition.

Whether duloxetine once daily can help patients with Chronic Low Back Pain.

Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.

Detailed description:

Arms: arm 1: 30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase arm 2: every day (QD), by mouth (PO), 13 weeks
Interventions: intervention 1: Duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: 30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase intervention 2: every day (QD), by mouth (PO), 13 weeks

Protocol documents:
Clinical trial NCT00426153
Conditions: Polycystic Kidney, Autosomal Dominant Polycystic Liver Disease Hepatomegaly Liver Diseases Kidney, Polycystic Abdominal Pain
Sponsor: Mayo Clinic
Start date: 2007-01-01; Completion date: 2008-10-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effect of Octreotide LAR® on the liver volumes of patients with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration, liver resection or liver transplantation. A total of 42 patients will be recruited -14 who will receive placebo and 28 the study drug. Preliminary evidence indicates that this drug is safe and non-toxic in other disease states. Treatment with this drug holds promise not only for individuals with liver involvement, but also for many more patients with polycystic kidney disease.

Detailed description:
The primary aim of this study is to compare the effect of Octreotide LAR® Depot on the liver volume of patients with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration, liver resection or liver transplantation compared with placebo. The secondary aims of the study are: (1)Assess the effect of Octreotide LAR® Depot on the total kidney volume and iothalamate clearance in patients with polycystic kidney disease associated with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration, liver resection or liver transplantation. (2)Evaluate quality of life changes associated with the administration of Octreotide LAR® Depot in these patients. (3)Assess toxicity of Octreotide LAR® Depot in patients with polycystic liver disease (PLD).

Note: Subjects who completed this 1 year randomized trial were offered enrollment into an open-label (all subjects received Octreotide) extension trial for an additional two years of treatment.

Arms: arm 1: Participants received Octreotide LAR® Depot injections (up to 40 mg) intramuscularly every 28 days (+/- 5 days) for one year arm 2: Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
Interventions: intervention 1: Octreotide intervention 2: Placebo
Intervention descriptions: intervention 1: Participants received Octreotide LAR® Depot injections (up to 40 mg)intramuscularly every 28 days (+/- 5 days) for one year intervention 2: Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year

Protocol documents:
Clinical trial NCT00427934
Conditions: Arthritis, Rheumatoid
Sponsor: Pfizer
Start date: 2007-02-01; Completion date: 2008-10-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether maraviroc, an investigational drug given with methotrexate (MTX) is safe and effective in the treatment of rheumatoid arthritis in adult patients.

Detailed description:
Following a planned interim analysis in the POC component on 21 August 2008 by the internal DMC (Data Monitoring Committee) of study A4001056, the trial was discontinued due to lack of efficacy. All participating investigators/country offices and monitors were notified on 22 August 2008 to cease patient enrollment. The DMC indicated that maraviroc was well tolerated in the Rheumatoid Arthritis patients and there were no safety concerns in the study. The termination date of this trial was 07 October 2008 when the last patient last visit occurred.

Arms: arm 1: None arm 2: This study was divided into two components: safety/pharmacokinetic (PK) and proof-of-concept (POC). In the safety/PK component either 150 mg or 300 mg tablets of maraviroc was administered twice a day (BID) to 16 rheumatoid arthritis subjects for 4 weeks.
Interventions: intervention 1: Maraviroc intervention 2: Maraviroc Placebo
Intervention descriptions: intervention 1: 300 mg (2- 150 mg tablets) are administered by mouth twice a day (BID) for 12 weeks. intervention 2: Placebo tablets to match active drug. Two tablets are administered by mouth twice a day (BID) for 12 weeks.

Protocol documents:
Clinical trial NCT00440271
Conditions: HIV Infections
Sponsor: Boehringer Ingelheim
Start date: 2007-02-01; Completion date: 2008-10-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to:

1. Demonstrate the safety and efficacy of tipranavir/ritonavir (TPV/r) among a racially diverse HIV+ population (males and females) who are three-class (nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), and protease inhibitor (PI)) experienced with documented resistance to more than one PI.
2. Determine pharmacokinetic data in this racially and gender diverse population.
3. Determine the potential utility of using therapeutic drug monitoring (TDM) in improving efficacy outcomes.

Detailed description:

Arms: arm 1: Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted. arm 2: Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
Interventions: intervention 1: tipranavir intervention 2: ritonavir intervention 3: Optimized Background Regimen (OBR)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Patients received between two and four active anti-retroviral medications based on resistance testing results, as background treatment, and remained on these for the duration of the trial.

Protocol documents:
Clinical trial NCT00441467
Conditions: Soft Tissue Sarcoma
Sponsor: Eleison Pharmaceuticals LLC.
Start date: 2007-03-01; Completion date: 2008-10-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

1\. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by objective response rate

Secondary Objectives:

1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by duration of response, progression-free survival and overall survival
2. To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma

Exploratory Objectives:

1. To evaluate the biological effect of glufosfamide on the metabolic profile in subjects with advanced soft tissue sarcomas, as determined by FDG-PET
2. To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins

Detailed description:

Arms: arm 1: Glufosfamide
Interventions: intervention 1: Glufosfamide
Intervention descriptions: intervention 1: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.

Protocol documents:
Clinical trial NCT00441701
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-12-01; Completion date: 2008-10-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two-part study conducted at multiple centers, of navarixin (SCH 527123, MK-7123) in participants with moderate to severe chronic obstructive pulmonary disease (COPD). Part 1 of the study is a double-blind, placebo-controlled, randomized, rising-dose study consisting of four treatment groups enrolled in three cohorts. The duration of treatment, for each cohort, will be a 2-week run-in period, followed by a 12-week double-blind treatment period. Treatment initiation for each cohort was staggered by 4 weeks to allow for safety assessment prior to use of higher doses of navarixin. Part 2 of the study will be a double-blind, placebo-controlled, randomized, parallel group study consisting of four treatment groups enrolled as one cohort. The duration of treatment will consist of a 2-week run-in period, followed by a 12-week double-blind treatment period.

Detailed description:

Arms: arm 1: Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) once daily (QD) for up to 12 weeks arm 2: Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks arm 3: Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks arm 4: Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks arm 5: Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks arm 6: Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks arm 7: Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks arm 8: Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks arm 9: Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks arm 10: Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
Interventions: intervention 1: Navarixin 1 mg intervention 2: Navarixin 10 mg intervention 3: Placebo to match navarixin intervention 4: Rescue medication
Intervention descriptions: intervention 1: Navarixin 1 mg capsules intervention 2: Navarixin 10 mg capsules intervention 3: Placebo to navarixin capsules intervention 4: Salbutamol/albuterol - 2 puffs of salbutamol/albuterol approximately every 4 hours as needed for dyspnea relief

Protocol documents:
Clinical trial NCT00442260
Conditions: Metastatic Breast Cancer
Keywords: breast cancer advanced breast cancer
Sponsor: West Virginia University
Start date: 2007-02-01; Completion date: 2008-10-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Dose Finding and Efficacy Evaluation of DOXIL (Doxorubicin HCL Liposome Injection) in Combination with Abraxane (Abraxane) in Patients with Metastatic Breast Cancer (MBC) \[Phase I and II\]

Detailed description:
Phase I Objectives

* To determine the Maximum Tolerated Dose (MTD) of the combination of (DOXIL) and Abraxane in patients with Metastatic Breast Cancer (MBC).
* Determine the dose-limiting toxicity (DLT) of DOXIL and Abraxane.

Phase II Objectives

Primary Objective

* To determine the response rate of DOXIL and Abraxane in patients with MBC.

Secondary Objectives

* To determine the time to disease progression in patients with MBC receiving DOXIL and Abraxane.
* To assess the tolerability of this regimen in women with MBC and assess toxicity profile

Arms: arm 1: Limited dose-escalation study of Abraxane and fixed dose of DOXIL in order to identify correct dose and side effect profile of the combination.
Interventions: intervention 1: DOXIL intervention 2: Abraxane
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00442897
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolaemia
Sponsor: Organon and Co
Start date: 2006-09-01; Completion date: 2008-10-01
Enrollment: 229 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: simvastatin (+) ezetimibe intervention 2: Comparator: atorvastatin
Intervention descriptions: intervention 1: simvastatin (+) ezetimibe 10/20mg, tablet, once daily, 12wks(sub group:24wks) intervention 2: atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)

Protocol documents:
Clinical trial NCT00444275
Conditions: GERD
Keywords: Gastroesophageal Reflux Disease Acid Reflux
Sponsor: AstraZeneca
Start date: 2007-03-01; Completion date: 2008-10-01
Enrollment: 3029 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: esomeprazole (Nexium®) intervention 2: Xolaam®
Intervention descriptions: intervention 1: This randomized study was conducted on parallel groups and included two phases:

* One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
* One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed intervention 2: This randomized study was conducted on parallel groups and included two phases:

* One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision
* One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed

Protocol documents:
Clinical trial NCT00447902
Conditions: HIV Infections
Keywords: treatment experienced
Sponsor: Boehringer Ingelheim
Start date: 2007-03-01; Completion date: 2008-10-01
Enrollment: 11 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The main purposes of this study are: demonstrate the safety and efficacy of TPV/r among HCV or hepatitis B virus (HBV) co-infected HIV+population, three-class (NRTI, NNRTI, and PI) experienced, with documented resistance to more than one PI. Determine pharmacokinetic data in this co-infected population and potential utility of using therapeutic drug monitoring (TDM) in improving efficacy outcomes.

Detailed description:

Interventions: intervention 1: tipranavir intervention 2: ritonavir
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00448175
Conditions: Overactive Bladder
Keywords: OAB symptoms of urgency, frequency, and urge incontinence
Sponsor: Uroplasty, Inc
Start date: 2006-06-01; Completion date: 2008-10-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Urgent PC Neuromodulation System intervention 2: Tolterodine
Intervention descriptions: intervention 1: The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). intervention 2: None

Protocol documents:
Clinical trial NCT00450216
Conditions: Ulcer
Keywords: ibuprofen famotidine ulcers NSAIDS pain arthritis chronic regional pain syndrome chronic soft tissue pain osteoarthritis rheumatoid arthritis chronic low back pain
Sponsor: Amgen
Start date: 2007-03-01; Completion date: 2008-10-01
Enrollment: 906 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.

Detailed description:
HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine. The study is designed to determine whether the combination product reduces the rate of ulcer development in subjects who require long-term daily use of ibuprofen.

Subjects will be assigned randomly, in approximately a 2:1 ratio, to treatment with either HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) or ibuprofen (800 mg) three times daily for a 24 week treatment period or until they develop either an endoscopically-diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Subjects will visit the study center for Screening and at Weeks 4, 8, 16, and 24. Physical exams will be performed, and clinical laboratory measurements made, at selected times during the study. Endoscopic exams will be performed during Screening and at Weeks 8, 16, and 24. Subjects will be contacted four weeks following study completion.

Study with completed results acquired from Horizon in 2024.

Arms: arm 1: HZT-501: Ibuprofen 800mg/famotidine 26.6mg arm 2: Ibuprofen 800mg
Interventions: intervention 1: Ibuprofen/famotidine intervention 2: Ibuprofen
Intervention descriptions: intervention 1: HZT-501: Ibuprofen800mg/famotidine 26.6mg administered orally 3 times daily for 24 weeks intervention 2: Ibuprofen 800mg administered orally 3 times daily for 24 weeks

Protocol documents:
Clinical trial NCT00450658
Conditions: Peptic Ulcer
Keywords: ibuprofen famotidine ulcers NSAIDS pain arthritis chronic regional pain syndrome chronic soft tissue pain osteoarthritis rheumatoid arthritis chronic low back pain
Sponsor: Amgen
Start date: 2007-03-01; Completion date: 2008-10-01
Enrollment: 627 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.

Detailed description:
HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine. The study is designed to determine whether the combination product reduces the rate of ulcer development in subjects who require long-term daily use of ibuprofen.

Subjects will be assigned randomly, in approximately a 2:1 ratio, to treatment with either HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) or ibuprofen (800 mg) three times daily for a 24 week treatment period or until they develop either an endoscopically-diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Subjects will visit the study center for Screening and at Weeks 4, 8, 16, and 24. Physical exams will be performed, and clinical laboratory measurements made, at selected times during the study. Endoscopic exams will be performed during Screening and at Weeks 8, 16, and 24. Subjects will be contacted four weeks following study completion.

Study with completed results acquired from Horizon in 2024

Arms: arm 1: HZT-501: Ibuprofen 800mg/Famotidine 26.6mg arm 2: Ibuprofen 800mg
Interventions: intervention 1: HZT-501 intervention 2: Ibuprofen
Intervention descriptions: intervention 1: HZT-501: Ibuprofen 800mg/famotidine 26.6mg orally 3 times daily for 24 weeks intervention 2: Ibuprofen 800mg orally 3 times daily for 24 weeks

Protocol documents: