ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01374490
Conditions: HIV Enteropathy Diarrhea With HIV
Keywords: HIV + HIV positive HIV associated diarrhea AIDS Diarrhea
Sponsor: Bausch Health Americas, Inc.
Start date: 2011-06-07; Completion date: 2012-10-31
Enrollment: 250 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive (HIV+) subjects with diarrhea.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Crofelemer
Intervention descriptions: intervention 1: Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.

Protocol documents:
Clinical trial NCT00473330
Conditions: Diabetes Mellitus Macular Edema
Keywords: Lucentis DME Diabetes Vision loss
Sponsor: Genentech, Inc.
Start date: 2007-06-01; Completion date: 2012-11-01
Enrollment: 377 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study of the efficacy and safety of ranibizumab injection in patients with clinically significant macular edema with center involvement (CSME-CI) secondary to diabetes mellitus (Type 1 or 2). This study is identical in design to study NCT00473382 (Protocol ID FVF4168g).

The open-label extension phase of the study was stopped after receiving FDA approval of the study drug (ranibizumab) for diabetic macular edema.

Detailed description:
This study is composed of 3 phases: (1) A 24-month controlled treatment period (monthly treatment with ranibizumab 0.3 mg, ranibizumab 0.5 mg, or sham injection) followed by (2) a 12-month treatment period in which patients randomized to the sham group who had not discontinued from treatment (still masked) could choose to receive monthly ranibizumab 0.5 mg while the 2 ranibizumab treatment groups continued on the same treatment they received in the first 2 years. Patients who had not discontinued treatment by Month 36 were eligible to continue treatment with ranibizumab 0.5 mg as needed (pro re nata, PRN) in (3) an extension phase of the study for up to 2 more years, resulting in up to 5 years possible total treatment time for some patients.

Arms: arm 1: Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata \[PRN\]) for up to 24 additional months. arm 2: Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata \[PRN\]) for up to 24 additional months. arm 3: Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata \[PRN\]) for up to 24 additional months.
Interventions: intervention 1: Ranibizumab intervention 2: Sham injection
Intervention descriptions: intervention 1: Sterile solution for intravitreal injection. intervention 2: None

Protocol documents:
Clinical trial NCT00676143
Conditions: Alzheimer Disease
Keywords: antibody immunotherapy
Sponsor: Pfizer
Start date: 2008-01-01; Completion date: 2012-11-01
Enrollment: 1100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: bapineuzumab intervention 2: placebo
Intervention descriptions: intervention 1: Bapineuzumab 0.5 mg/kg administered by IV infusion approximately every 13 weeks through week 65. intervention 2: Placebo will be administered by IV infusion approximately every 13 weeks through week 65.

Protocol documents:
Clinical trial NCT01072630
Conditions: Depression
Keywords: Bipolar I Disorder
Sponsor: Cephalon
Start date: 2010-03-01; Completion date: 2012-11-01
Enrollment: 492 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.

Detailed description:

Arms: arm 1: Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. arm 2: Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. arm 3: Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
Interventions: intervention 1: Armodafinil intervention 2: Placebo
Intervention descriptions: intervention 1: Doses of either 150mg/day or 200 mg/day in tablet form taken orally, once daily in the morning. intervention 2: Matching Placebo, also in tablet form taken orally, once daily in the morning.

Protocol documents:
Clinical trial NCT01197521
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Sponsor: AstraZeneca
Start date: 2010-09-01; Completion date: 2012-11-01
Enrollment: 923 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 1 year.

Detailed description:
Sub-study:

Full title: Optional Genetic Research

Date: 18 June 2010

Version: 1

Objectives: To collect and store, with appropriate consent ,DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or methotrexate; and/or susceptibility to, progression of and prognosis of RA

Arms: arm 1: Oral Treatment arm 2: Oral Treatment arm 3: Oral Treatment
Interventions: intervention 1: fostamatinib intervention 2: fostamatinib intervention 3: placebo, fostamatinib
Intervention descriptions: intervention 1: fostamatinib 100 mg twice daily intervention 2: fostamatinib 100 mg twice daily/150 mg once daily intervention 3: Placebo for 24 weeks followed by fostamatinib 100 mg twice daily

Protocol documents:
Clinical trial NCT01264939
Conditions: Chronic Idiopathic Urticaria
Sponsor: Genentech, Inc.
Start date: 2011-02-01; Completion date: 2012-11-01
Enrollment: 336 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a global Phase III, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the safety and efficacy of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with chronic idiopathic urticaria (CIU) who remain symptomatic despite standard-dosed H1 antihistamine treatment (including doses up to 4 times above the approved dose level), H2 blockers, and/or leukotriene receptor antagonists (LTRA).

Detailed description:

Arms: arm 1: Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period. arm 2: Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
Interventions: intervention 1: Omalizumab intervention 2: Placebo intervention 3: H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist intervention 4: Diphenhydramine
Intervention descriptions: intervention 1: Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial. intervention 2: Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug. intervention 3: Participants were required to maintain stable doses of their pre-randomization combination therapy with an H1 antihistamine and either an H2 blocker or leukotriene receptor antagonist, or all 3 drugs in combination, throughout the 24-week treatment period and 16-week follow-up period of the 40-week study. intervention 4: Participants were provided with diphenhydramine 25 mg for itch relief on an as-needed basis, up to a maximum of 3 doses within 24 hours for the duration of the 40-week study.

Protocol documents:
Clinical trial NCT01281189
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis ALS Motor Neurone Disease Motor Neuron Disease Lou Gehrig's disease
Sponsor: Knopp Biosciences
Start date: 2011-03-01; Completion date: 2012-11-01
Enrollment: 942 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).

Detailed description:
Amyotrophic Lateral Sclerosis (ALS) is a rapidly progressive, degenerative disease of motor neurons in the brain and spinal cord that leads to muscle atrophy and spasticity in limb and bulbar muscles resulting in weakness and loss of ambulation, oropharyngeal dysfunction, weight loss, and ultimately respiratory failure. The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of ALS.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dexpramipexole intervention 2: Placebo
Intervention descriptions: intervention 1: Oral tablet 150mg twice daily for up to 18 months. intervention 2: Oral tablet twice daily for up to 18 months.

Protocol documents:
Clinical trial NCT01358526
Conditions: Low Back Pain
Keywords: Low back pain Chronic pain Opioid Moderate to severe chronic low back pain
Sponsor: Purdue Pharma LP
Start date: 2011-05-01; Completion date: 2012-11-01
Enrollment: 1095 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the efficacy and safety of OXN compared to placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back pain who require around-the-clock opioid therapy.

Detailed description:

Arms: arm 1: Oxycodone/Naloxone Controlled-release Tablets (OXN) arm 2: Placebo tablets to match OXN
Interventions: intervention 1: Oxycodone/Naloxone Controlled-release intervention 2: Placebo
Intervention descriptions: intervention 1: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours intervention 2: Placebo tablets to match OXN taken orally every 12 hours

Protocol documents:
Clinical trial NCT01570686
Conditions: Hypertension
Keywords: Food effect, hypertension, aliskiren
Sponsor: Novartis Pharmaceuticals
Start date: 2012-04-01; Completion date: 2012-11-01
Enrollment: 589 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of food on aliskiren's efficacy, pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light meal versus fasted conditions.

Detailed description:

Arms: arm 1: Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast arm 2: Aliskiren 300 mg once daily taken after after an overnight fast
Interventions: intervention 1: Aliskiren
Intervention descriptions: intervention 1: Aliskiren 300 mg once daily

Protocol documents:
Clinical trial NCT00054275
Conditions: Breast Cancer
Keywords: recurrent breast cancer stage IV breast cancer male breast cancer
Sponsor: Paula Silverman, MD
Start date: 2002-12-01; Completion date: 2012-11-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with docetaxel may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining erlotinib with docetaxel in treating patients who have stage IV or recurrent breast cancer.

Detailed description:
OBJECTIVES:

* Determine the antitumor effects of erlotinib and docetaxel, in terms of objective response, stabilization of disease, and progression-free survival, in patients with stage IV or recurrent breast cancer.
* Determine time to tumor progression in patients treated with this regimen.
* Compare time to tumor progression in patients who achieve disease stabilization or response after treatment with this regimen and continue to receive erlotinib versus patients who do not receive additional erlotinib.

OUTLINE: Patients receive docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily beginning on day 1. Treatment repeats every 4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients achieving maximal tumor response or stabilization of disease after 6 courses may continue to receive erlotinib alone until disease progression.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12-14 months.

Arms: arm 1: None
Interventions: intervention 1: docetaxel intervention 2: erlotinib hydrochloride
Intervention descriptions: intervention 1: Docetaxel IV infusion weekly for 3 weeks with a one-week break. One cycle is 4 weeks (28 days). Patients' actual weight will be used to calculate dose. intervention 2: OSI-774 will be taken 1 hour before or 2 hours after meals. Cycle 1 will be administered at dose level -1.If no grade 3 or 4 toxicity occurs during cycle 1, then the patient may proceed to be treated at dose level 0 for the remaining chemotherapy cycles.

Protocol documents:
Clinical trial NCT00134381
Conditions: Healthy
Keywords: Normal volunteer study
Sponsor: Rutgers, The State University of New Jersey
Start date: 2003-05-01; Completion date: 2012-11-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate whether topically applied constituents of green tea \[caffeine or (-)-epigallocatechin gallate; EGCG\] have a protective effect on skin exposed to ultraviolet light (UV).

Detailed description:
The purpose of this study is to investigate if topically applied constituents of green tea \[caffeine or (-) - epigallocatechin gallate; EGCG\] have a protective effect on skin exposed to ultraviolet light (UV). In the double-blinded study all subjects will receive 311 nanometer UVB light at a dose that is 0.5-1.5X their individual minimal erythema dose (MED). One part of the experiment will involve applying a topical natural product (caffeine or EGCG) and placebo to bilateral symmetric sites. The natural product and the placebo will be applied immediately after and at 1/2 hour, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 24 hours, 25 hours, and 27 hours after exposure to a 0.5-1.5 MED dose of UV light. Another part of the study involves performing skin biopsies. One will be done prior to UVB exposure, 2 will be done at 24 hours and 2 more will be done at 48 hours.

Arms: arm 1: bilateral comparison of green tea constituent arm 2: bilateral comparison of placebo vehicle
Interventions: intervention 1: Green Tea intervention 2: Placebo
Intervention descriptions: intervention 1: Green tea product (EGCG or caffeine) in vehicle will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED) intervention 2: Placebo (vehicle alone) will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED)

Protocol documents:
Clinical trial NCT00148317
Conditions: Multiple Myeloma
Sponsor: Weill Medical College of Cornell University
Start date: 2005-06-01; Completion date: 2012-11-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
PRIMARY STUDY OBJECTIVES

* To evaluate the efficacy of the combination of bortezomib, dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as a therapy for two different subsets of multiple myeloma patients:

  1. Patients post first line therapy
  2. Patients with relapsed/refractory disease who are bortezomib-naïve
* To evaluate the safety of the combination of bortezomib and dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide as therapy for patients with multiple myeloma.

SECONDARY STUDY OBJECTIVES

* To evaluate the role of the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide on the ability to collect \> 10 x 106 CD34+ cells/kg in \< 7 collections (for both subsets of multiple myeloma patients).
* To evaluate the survival of patients who receive the combination of bortezomib dexamethasone, with and without DOXIL, followed by high-dose cyclophosphamide (for both subsets of patients).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Bortezomib intervention 2: dexamethasone intervention 3: liposomal doxorubicin intervention 4: cyclophoshamide intervention 5: filgrastim
Intervention descriptions: intervention 1: During Induction Phase (6 cycles): Bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 During 21-day mobilization cycle (1 cycle): Bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 intervention 2: During Induction Phase (6 cycles): dexamethasone 40 mg on days 1-4, 8-11, and 15-18 intervention 3: If patients achieve less then a PR during the induction phase after 2 cycles, or less then a CR after 4 cycles: Liposomal doxorubicin was added at 30 mg/m2 on day 4 for the remaining cycles intervention 4: During the 21 day mobilization phase (1 cycle): cyclophosphamide at 3 g/m2 on day 8 intervention 5: During the 21 day mobilization phase (1 cycle): 10 μg/kg/day for 10 consecutive days starting 24 hours after cyclophosphamide administration on day 9

Protocol documents:
Clinical trial NCT00176891
Conditions: Mucopolysaccharidosis I Hurler Syndrome
Keywords: Laronidase ERT Stem cell transplant storage disease inborn errors of metabolism hurler syndrome glycosaminoglycans enzyme replacement
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2004-03-01; Completion date: 2012-11-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators hypothesize that weekly infusions of Laronidase ERT for 10-12 weeks prior to transplant and 8 weeks following transplant will result in a reduction of glycosaminoglycans (GAG) burden that is associated with decreased complications following transplant.

Detailed description:
Subjects will receive laronidase once a week intravenously for 10-12 weeks prior to transplant and for approximately 8 weeks after transplant. Laronidase will be given by intravenous infusion (IV) through a catheter and from there to your child's body's cells and organs to break down the glycosaminoglycans (GAG) buildup.

Prior to starting ERT, subjects will have a complete physical examination, which includes a complete assessment of your child's airway and lungs. In addition to standard treatment evaluations and tests, which are done prior to hematopoietic stem cell transplant (HSCT), subjects will have the following tests: an additional teaspoon of blood for a baseline test for serum antibodies against laronidase, before and after the fourth dose of laronidase, the investigators will collect 2 teaspoons of blood for an alpha-L-iduronidase enzyme level; to watch for side effects to laronidase and the development of antibodies to laronidase, approximately 2 teaspoons of blood will be collected every 3 weeks while the subject is receiving laronidase ERT.

Arms: arm 1: Weekly infusion of laronidase enzyme replacement therapy followed by hematopoietic stem cell transplant.
Interventions: intervention 1: Stem Cell Transplant intervention 2: Laronidase ERT
Intervention descriptions: intervention 1: enzyme replacement 10-12 weeks prior to hematopoietic stem cell transplant (HSCT), and 8 weeks following intervention 2: Laronidase ERT will be administered 10-12 weeks prior to HSCT, and 8 weeks following.

Protocol documents:
Clinical trial NCT00185731
Conditions: Leukemia Lymphoma, Non-Hodgkin
Sponsor: Dean Felsher
Start date: 2005-04-01; Completion date: 2012-11-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an approach which can inflict significant toxicity. An alternative is to block expression of oncogenes which are over-expressed only in cancer cells, a therapeutic approach which could reduce toxicity to the host while maximizing destruction of the oncogene-dependent malignant cells.

Detailed description:
Atorvastatin has been shown to decrease levels of active oncogenes in preclinical studies with murine and human lymphoma cell lines, and administration of statins leads to shrinkage of lymphoma in murine models. Therefore, it may be possible for atorvastatin to decrease levels of active oncogenes in human lymphomas. Further, upon decrease in levels of active oncogenes, human lymphomas may regress. Atorvastatin is a commonly prescribed drug for hypercholesterolemia: targeting the 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase enzyme may also be a way to decrease activation of oncogenes in human lymphoma, with minimal toxicity. For human low grade non-Hodgkin lymphoma, no curative treatment is available; therefore new, non-toxic and targeted therapies are sought for this disease.

Arms: arm 1: Atorvastatin, 80 mg tablet, will be taken orally by the patient daily, beginning on study day 1.
Interventions: intervention 1: Atorvastatin
Intervention descriptions: intervention 1: 80 mg orally once daily

Protocol documents: