ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00507455
Conditions: Lower Urinary Tract Symptoms Bladder Outlet Obstruction
Keywords: Lower Urinary Tract Symptoms Bladder Outlet Obstruction Treatment Solifenacin Succinate Tamsulosin hydrochloride
Sponsor: Astellas Pharma Inc
Start date: 2007-06-01; Completion date: 2008-08-01
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).

Detailed description:

Arms: arm 1: Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks. arm 2: Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks. arm 3: Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
Interventions: intervention 1: solifenacin succinate intervention 2: tamsulosin hydrochloride intervention 3: Placebo to solifenacin intervention 4: Placebo to tamsulosin
Intervention descriptions: intervention 1: Solifenacin succinate tablets intervention 2: Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00003820
Conditions: Lymphoma Hodgkin Lymphoma (Category) Nodular Lymphocyte Predominant Hodgkin Lymphoma
Sponsor: Ranjana Advani
Start date: 1999-01-01; Completion date: 2008-08-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant Hodgkin's lymphoma.

Detailed description:
This study will evaluate the partial, complete, and overall response rates to rituximab of subjects with lymphocyte-predominant Hodgkin's lymphoma. Subjects will receive rituximab by IV infusion over several hours once a week for 4 weeks, followed by maintenance therapy as repeat course of the same dose and schedule rituximab at 6, 12, and 18 months.

This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.

Arms: arm 1: 375 mg/m2 rituximab by IV infusion weekly. The initial course of treatment is 4 weeks.

Subjects who achieve an objective response or stable disease after the initial course (4 weeks) were permitted to continue additional 4-week cycles of treatment, for 3 additional courses starting every 6 months (ie, at 6; 12; and 18 months).
Interventions: intervention 1: Rituximab
Intervention descriptions: intervention 1: Rituximab (biosimilar is Zytux) is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B-cells. Rituximab destroys B-cells and is therefore used to treat diseases which are characterized by excessive numbers of B-cells, overactive B-cells, or dysfunctional B-cells. This includes many lymphomas, leukemias, transplant rejection, and autoimmune disorders.

Protocol documents:
Clinical trial NCT00089635
Conditions: Colorectal Cancer Metastases
Keywords: Colon, Rectal Cancer ABX-EGF, Panitumumab, EGFr Immunex, Abgenix, Amgen Metastatic Colorectal Cancer Vectibix
Sponsor: Amgen
Start date: 2004-08-01; Completion date: 2008-08-01
Enrollment: 203 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine that panitumumab will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy.

Detailed description:

Arms: arm 1: Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
Interventions: intervention 1: Panitumumab
Intervention descriptions: intervention 1: Administered by intravenous infusion

Protocol documents:
Clinical trial NCT00100815
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas recurrent pancreatic cancer stage IV pancreatic cancer
Sponsor: Roswell Park Cancer Institute
Start date: 2004-08-01; Completion date: 2008-08-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine and capecitabine together with bevacizumab works in treating patients with metastatic or unresectable pancreatic cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine progression-free survival of patients with metastatic or unresectable adenocarcinoma of the pancreas treated with gemcitabine, capecitabine, and bevacizumab.

Secondary

* Determine clinical response in patients treated with this regimen.
* Determine toxicity of this regimen in these patients.
* Determine quality of life of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on day 1, oral capecitabine twice daily on days 1-14, and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline then weekly for 3 weeks.

Patients are followed every 2-4 months for 1 year and then every 6 months for at least 5 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 8.8-17.5 months.

Interventions: intervention 1: bevacizumab intervention 2: capecitabine intervention 3: gemcitabine hydrochloride
Intervention descriptions: intervention 1: 30-90 minutes on day 1, every 21 days up to 12 months. intervention 2: twice daily on days 1-14. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. intervention 3: IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00102687
Conditions: Myelodysplastic Syndromes
Sponsor: Celgene
Start date: 2005-01-01; Completion date: 2008-08-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if azacitidine, combined with Best Supportive Care (BSC), is effective in treating myelodysplastic syndromes (MDS) when given according to a different doses and dosing schedules.

Detailed description:
Comparison/Control Interventions: The comparison is azacitidine at different doses and schedules.

Duration of Intervention: Treatment lasted for a maximum of 18 cycles, which is up to 24 months.

Arms: arm 1: Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle. arm 2: Azacitidine administered subcutaneously at 75mg/m\^2 for 5days with 2 days off, then for an additional 2 days, on a 28 day cycle. arm 3: Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle. arm 4: Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days every 4 weeks. arm 5: Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days every 6 weeks.
Interventions: intervention 1: azacitidine
Intervention descriptions: intervention 1: Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.

Protocol documents:
Clinical trial NCT00116831
Conditions: Atherosclerosis
Keywords: atheroma IVUS Intravascular ultrasound atherosclerosis
Sponsor: GlaxoSmithKline
Start date: 2005-01-01; Completion date: 2008-08-01
Enrollment: 672 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the safety and effectiveness of rosiglitazone against a sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels of the heart.

Detailed description:

Arms: arm 1: oral anti-diabetic medication arm 2: oral anti-diabetic medication
Interventions: intervention 1: Glipizide intervention 2: rosiglitazone maleate
Intervention descriptions: intervention 1: oral anti-diabetic medication intervention 2: oral antidiabetic medication

Protocol documents:
Clinical trial NCT00118365
Conditions: Precancerous Condition
Sponsor: National Cancer Institute (NCI)
Start date: 1998-07-01; Completion date: 2008-08-01
Enrollment: 375 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer

Detailed description:
PRIMARY OBJECTIVES:

I. Compare the rate of new adenomatous polyp formation in patients with a history of adenomatous polyps of the colon treated with eflornithine and sulindac vs placebo.

II. Correlate the effects of eflornithine and sulindac on polyamine and prostaglandin content in the flat mucosa with the rate of new adenoma formation in these patients.

III. Compare the rate of side effects in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and aspirin use (yes vs no).

Patients receive oral double placebo once daily for 4 weeks. Patients who are more than 70% compliant by pill measurement or self reporting are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral double placebo once daily.

Arm II: Patients receive oral eflornithine (DFMO) and oral sulindac once daily.

In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.

Arms: arm 1: Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. arm 2: Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.
Interventions: intervention 1: placebo intervention 2: eflornithine intervention 3: sulindac intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Given orally intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT00125515
Conditions: Opioid Dependence
Keywords: Heroin Opiates naltrexone memantine
Sponsor: New York State Psychiatric Institute
Start date: 2005-06-01; Completion date: 2008-08-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to test the efficacy of memantine (a noncompetitive NMDA receptor antagonist) as an adjunct to the maintenance treatment with naltrexone in detoxified heroin-dependent individuals.

Detailed description:
The primary aim of this study is to test the efficacy of memantine, a noncompetitive NMDA receptor antagonist, in reducing early attrition and improving outcome in opioid-dependent individuals maintained on naltrexone.

This double-blind, 12-week trial will include heroin-dependent patients who completed detoxification. Participants will be randomly assigned to one of three conditions: naltrexone and placebo, naltrexone and memantine (15 mg bid), or naltrexone and memantine (30 mg bid). Naltrexone will be taken 3 times each week at the clinic, while memantine or placebo will be taken at home. In addition, twice each week patients will receive a psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The goal of the psychosocial intervention is to improve compliance with medication and maintain abstinence. Baseline assessments will be taken and compared to those completed at study visits, which will occur 3 times each week.

Arms: arm 1: Placebo plus oral naltrexone arm 2: Memantine 30 mg bid plus oral naltrexone arm 3: memantine 15 mg bid plus oral naltrexone
Interventions: intervention 1: Memantine intervention 2: Naltrexone
Intervention descriptions: intervention 1: One arm receives 30 mg bid and the other arm receives receives 15mg bid intervention 2: Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.

Protocol documents:
Clinical trial NCT00128830
Conditions: Human Immunodeficiency Virus Type 1
Keywords: Human Immunodeficiency Virus Type 1 HIV-1 infection TMC125 Etravirine Enfuvirtide Antiretroviral therapy
Sponsor: Tibotec Pharmaceuticals, Ireland
Start date: 2005-06-01; Completion date: 2008-08-01
Enrollment: 211 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term safety and tolerability of etravirine, administered as part of an individually optimized antiretroviral therapy (ART), in human immunodeficiency virus Type 1 (HIV-1) infected participants.

Detailed description:
This is a Phase II, open-label (all people know the identity of the intervention), roll-over study (participants may go ahead and participate in another clinical study). Participants who were randomized (study medication is assigned by chance) to a etravirine (ETR) treatment arm in Phase II TMC125 feeder studies (TMC125-C203, TMC125-C209, TMC125-C223 and TMC125-C211), were treated for at least 48 weeks with etravirine, and who will derive continued benefit from etravirine therapy, as judged by the investigator, will be enrolled in this study. The final visit of the sponsor-selected Phase II ETR study will be the first (baseline) visit of this study. Approximately 300 participants will be enrolled in this study who will receive 800 mg twice daily of etravirine (formulation TF035) until the formulation 200 mg twice daily (formulation F060) is available. Once this formulation becomes available all the participants will be switched to receive F060 which will be given in combination with an investigator-selected, optimized underlying therapy (nucleotide reverse transcriptase \[NRTIs\] and/or allowed protease inhibitors and/or enfuvirtide). Participants will continue to receive ETR until they are no longer benefitted or this medication becomes commercially available. Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination.

Arms: arm 1: None
Interventions: intervention 1: Etravirine (ETR) intervention 2: Nucleotide reverse transcriptase inhibitors (NRTIs) intervention 3: Protease inhibitors (PIs) intervention 4: Enfuvirtide (ENF)
Intervention descriptions: intervention 1: Participants will receive 800 mg of ETR (2 x 4 tablets of formulation TF035) twice daily and after the formulation switch they will receive 200 mg of ETR (2 x 2 tablets of formulation F060) twice daily until the participants benefitted from etravirine or it became comercially available. intervention 2: Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF). intervention 3: Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF). intervention 4: Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).

Protocol documents:
Clinical trial NCT00154375
Conditions: Glioblastoma Multiforme Astrocytoma
Keywords: Open label Imatinib mesylate hydroxyurea temozolomide resistant protein tyrosine kinases adenocarcinoma glioblastoma multiforme astrocytoma brain tumor brain cancer
Sponsor: Novartis Pharmaceuticals
Start date: 2004-10-01; Completion date: 2008-08-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase III study comparing Imatinib mesylate and hydroxyurea combination therapy with hydroxyurea monotherapy in patients with temozolomide resistant progressive glioblastoma.

Detailed description:

Arms: arm 1: Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening. arm 2: 1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
Interventions: intervention 1: Imatinib mesylate intervention 2: Hydroxyurea
Intervention descriptions: intervention 1: Imatinib was supplied as 100 mg and 400 mg tablets packaged in polyethylene bottles. intervention 2: None

Protocol documents:
Clinical trial NCT00159419
Conditions: Osteogenesis Imperfecta Osteoporosis Paget Disease of Bone
Keywords: Osteogenesis Imperfecta Fractures Pediatric Osteoporosis Juvenile Pagets
Sponsor: Indiana University School of Medicine
Start date: 1999-08-01; Completion date: 2008-08-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." We, the researchers at Indiana University School of Medicine, are characterizing the changes effected by oral bisphosphonate therapy and comparing them to a regimen of intravenous bisphosphonate therapy in a group of children with OI and also in children with other disorders that result in low bone mass and fractures.

Detailed description:
The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." OI is an inherited disorder of collagen synthesis. Collagen is the major structural protein of the matrix of tendons, skin, and bones. Affected persons have low bone mineral density (and experience multiple fractures and progressive bony deformity). In its most severe form, the disorder is lethal in infancy. We plan to characterize the changes effected by oral bisphosphonate therapy and compare them to a regimen of intravenous bisphosphonate therapy in a group of children with OI.

Additionally, we have begun to treat patients with OI and other conditions of low bone mineralization for age who are not eligible for the standard protocol (too young, history of abdominal pain, etc.) with bisphosphonate. We also plan to screen the parents and siblings of our patients diagnosed with osteogenesis imperfecta, in order to determine if they also have osteoporosis.

Arms: arm 1: 1 mg/kg po qd rounded to nearest 10 or 20 mg dose arm 2: 3 mg/kg IV q4 months
Interventions: intervention 1: Alendronate intervention 2: Pamidronate
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00178919
Conditions: Hypertension Pure Autonomic Failure
Keywords: Endothelial Nitric Oxide L-NMMA Trimethaphan Autonomic Nervous System Nitric Oxide Inhibition
Sponsor: Vanderbilt University
Start date: 2002-08-01; Completion date: 2008-08-01
Enrollment: 112 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The amount of blood flowing to the different parts of the body is regulated by the autonomic (automatic) nerves and by local factors produced by the blood vessels. Nitric oxide (NO) is one of the most important of these metabolic factors. If the production of NO is slowed or stopped the amount of blood to the different parts of the body is decreased. There is increasing knowledge that NO mechanisms are impaired in a number of medical conditions. NO function is reduced in patients with risk factors for atherosclerosis (hardening of the arteries) such as hypercholesterolemia (patients with high cholesterol), or diabetes mellitus, and is also impaired in smokers. This NO "deficiency" is believed to contribute to the greater cardiovascular risk that marks these patient populations. This study is designed to examine if endothelial nitric oxide is an important control mechanism of blood pressure under normal conditions, and if impairment of nitric oxide contributes to hypertension.

Detailed description:

Arms: arm 1: To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system in Patients with Autonomic Failure. arm 2: To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system in normal volunteers and hypertensive subjects.
Interventions: intervention 1: L-NMMA intervention 2: Trimethaphan
Intervention descriptions: intervention 1: IV infusion of 125, 250 and 500 mcg/Kg/min for 15 minutes each dose. The main outcome is the maximal increase in blood pressure produced at the end of the infusions or a maximal systolic blood pressure of 160 mm Hg. It could be achieved after the first dose or the third. intervention 2: IV infusion for the duration of the study at 4-6 mg/min depending on autonomic blockade. This is only to produce transient pharmacological blockade of the autonomic nervous system in order to allow the full expression of the inhibition of nitric oxide synthase. There is no direct outcome associated with this intervention.

Protocol documents: