ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00984490
Conditions: Breast Cancer
Keywords: stage I breast cancer stage II breast cancer
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2009-09-01; Completion date: 2011-07-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying how well metformin hydrochloride works in treating women with stage I or stage II breast cancer that can be removed by surgery.

Detailed description:
OBJECTIVES:

Primary

* To determine the in situ effects of metformin hydrochloride on proliferation (Ki67) and apoptosis (caspase-3) in women with operable stage I or II breast cancer.

Secondary

* To determine the in situ biologic effect of metformin hydrochloride on the AMP kinase, MTOR/PI3K, and IGF pathways in breast cancer (tissue S6K and phospho S6K, p53, p63, and p73 levels as well as p53 \[(Ser-15), if wild-type p53 is present\], p63 \[Ser-66/68, Ser-301, and Ser-361\], and p73 \[Y-99\] phosphorylation, PTEN \[clone 6H2.1\], phospho-Akt \[S473\], insulin receptor substrate 1 and 2 \[IRS-1 and IRS-2\], and LKB1).
* To determine if molecular classification (basal-type vs luminal A vs luminal B) and the established p63 and p73 RNA microarray gene signatures correlate with the metformin hydrochloride-induced effects on proliferation (Ki67), apoptosis (caspase-3) and the selected biomarkers (listed above) in breast cancer.
* To collect and analyze pre- and post-treatment peripheral blood specimens for serum glucose and insulin levels, as well as circulating IGF-1 and IGF binding protein 3 (IGFBP3).

OUTLINE: Patients receive oral metformin hydrochloride twice daily for 7-21 days. Approximately 24-36 hours after the last dose of metformin hydrochloride, patients undergo surgical resection (total mastectomy or segmental resection with lymph node evaluation) of tumor.

Patients undergo blood and tissue sample collection periodically for biomarker analysis.

Arms: arm 1: Metformin: 850 mg orally (PO) twice daily (BID) for 7-21 days, discontinued 24-36 hrs prior to surgery
Interventions: intervention 1: metformin hydrochloride intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Metformin: 850 mg orally (PO) twice daily (BID) for 7-21 days, discontinued 24-36 hrs prior to surgery intervention 2: Blood and tissue collection to determine the in situ biologic effect of metformin

Protocol documents:
Clinical trial NCT00984815
Conditions: Osteoarthritis Rheumatoid Arthritis Chronic Low Back Pain Chronic Regional Pain Syndrome Chronic Soft Tissue Pain
Keywords: NSAID Chronic Pain Osteoarthritis Rheumatoid Arthritis
Sponsor: Amgen
Start date: 2009-09-01; Completion date: 2011-07-01
Enrollment: 86 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients that require long-term NSAID treatment.

Detailed description:
HZT-501, a fixed-dose combination of ibuprofen, a pain and inflammation relieving non-steroidal anti-inflammatory drug (NSAID), and famotidine, a histamine type 2 receptor antagonist (H2RA), is being developed for the treatment of patients with signs and symptoms of osteoarthritis, rheumatoid arthritis, mild to moderate pain or dysmenorrhea who are at risk of developing ibuprofen-associated upper gastrointestinal ulcers.

Study with completed results acquired from Horizon in 2024.

Arms: arm 1: Open-label treatment with HZT-501
Interventions: intervention 1: HZT-501
Intervention descriptions: intervention 1: Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day

Protocol documents:
Clinical trial NCT00985712
Conditions: Diabetes Mellitus, Type 1
Sponsor: Eli Lilly and Company
Start date: 2009-10-01; Completion date: 2011-07-01
Enrollment: 263 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the hypothesis that the HumaPen Memoir with memory function, when used over 24 weeks for prandial insulin injections achieves superior glycemic control, when compared to the conventional HumaPen Luxura without memory function.

Detailed description:

Arms: arm 1: Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks arm 2: Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
Interventions: intervention 1: Insulin Lispro intervention 2: Huminsulin Regular intervention 3: HumaPen Memoir intervention 4: HumaPen Luxura
Intervention descriptions: intervention 1: subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks intervention 2: subcutaneously, daily (as determined by patient's blood glucose), for 24 weeks intervention 3: subcutaneously, daily for 24 weeks intervention 4: subcutaneously, daily for 24 weeks

Protocol documents:
Clinical trial NCT00986947
Conditions: Kidney Failure
Sponsor: Johns Hopkins University
Start date: 2009-09-01; Completion date: 2011-07-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Some patients who need kidney transplants have high levels of antibodies that make them incompatible with most potential deceased donor kidney offers. These patients are considered highly-sensitized and are very difficult to transplant because the likelihood that they will receive a compatible organ is very low. There are some medications and procedures that can decrease the antibody levels and this can increase the chance of finding a compatible donor for these patients. In this study the investigators will give two medications (IVIg and Rituximab) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplant. After the investigators administer these medications, the investigators will continue to check for compatibility as organ offers are received. If a compatible organ offer is received, the investigators will perform the transplant using that organ. The investigators hypothesize that these medications will lower antibody levels and increase the chance that a these patients are able to receive a compatible kidney transplant.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: IVIg and rituximab
Intervention descriptions: intervention 1: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.

If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA).

Protocol documents:
Clinical trial NCT00992186
Conditions: Prostate Cancer
Keywords: Prostate cancer Infusion Carlumab CNTO 888
Sponsor: Centocor Research & Development, Inc.
Start date: 2009-09-01; Completion date: 2011-07-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and effectiveness of the study drug carlumab in participants with metastatic castrate-resistant prostate cancer (cancer of the gland that makes fluid that aids movement of sperm).

Detailed description:
This is an open-label (all people know the identity of the intervention), multicenter trial (conducted in more than one center) in participants with metastatic castrate-resistant prostate cancer. The trial consists of 3 phases: screening period, treatment period of approximately 4 months, and a follow-up period (Week 1, 4, 8 and 12 after the last dose) of up to 12 weeks after the administration of last dose. The participants will receive carlumab at the dose of 15 milligram/kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression. Efficacy of the participants will be primarily evaluated by composite response. Participants' safety will be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Carlumab
Intervention descriptions: intervention 1: Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.

Protocol documents:
Clinical trial NCT01006265
Conditions: Multiple Sclerosis
Sponsor: Actelion
Start date: 2009-10-01; Completion date: 2011-07-01
Enrollment: 464 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.

Detailed description:

Arms: arm 1: ACT-128800 Dose 1 arm 2: ACT-128800 Dose 2 arm 3: ACT-128800 Dose 3 arm 4: Matching placebo
Interventions: intervention 1: ACT-128800 Dose 1 intervention 2: Placebo intervention 3: ACT-128800 Dose 2 intervention 4: ACT-128800 Dose 3
Intervention descriptions: intervention 1: ACT-128800 (Dose 1) administered orally once daily intervention 2: Matching placebo administered orally once daily intervention 3: ACT-128800 (Dose 2) administered orally once daily intervention 4: ACT-128800 (Dose 3) administered orally once daily

Protocol documents:
Clinical trial NCT01008995
Conditions: Psoriasis
Keywords: psoriasis asian patients Chinese ustekinumab CNTO 1275 Stelara
Sponsor: Centocor, Inc.
Start date: 2009-10-01; Completion date: 2011-07-01
Enrollment: 322 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy (good or bad effects) and safety of ustekinumab in the treatment of patients with moderate to severe psoriasis in China.

Detailed description:
In this study, 220 patients will be divided into two groups randomly (by chance), like flipping a coin. Each group will receive a different treatment. The results for each group are compared to each other. There are 2 treatment groups in this study, Group 1 and Group 2. Group 1 will receive placebo at Weeks 0 and 4, ustekinumab 45 mg at Weeks 12 and 16. Group 2 will receive ustekinumab 45 mg at Weeks 0, 4, and 16 and placebo at Week 12. All patients in the study will eventually receive ustekinumab after Week 12. The patients will be in the study for about 36 weeks, with study visit approximately 10 times. Effectiveness evaluations will be conducted throughout the study and include the Psoriasis Area and Severity Index (PASI), Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI). Safety assessments will also be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure) and the occurrence and severity of adverse events. GROUP 1: Placebo at Weeks 0 and 4, ustekinumab 45 mg at Weeks 12 and 16. GROUP 2: Ustekinumab 45 mg at Weeks 0, 4, and 16. Placebo at Week 12

Arms: arm 1: placebo Subcutaneous injection at Week 0 and 4,ustekinumab 45 mg subcutaneous injection at Week 12 and 16 arm 2: placebo Subcutaneous injection at Week 12,ustekinumab 45 mg subcutaneous injection at Week 0 4 and 16
Interventions: intervention 1: placebo intervention 2: ustekinumab intervention 3: placebo intervention 4: ustekinumab
Intervention descriptions: intervention 1: Subcutaneous injection at Week 0 and 4 intervention 2: 45 mg subcutaneous injection at Week 12 and 16 intervention 3: Subcutaneous injection at Week 12 intervention 4: 45 mg subcutaneous injection at Week 0, 4 and 16

Protocol documents:
Clinical trial NCT01047553
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease COPD Japanese Phase 3 Safety OT Oxis
Sponsor: AstraZeneca
Start date: 2009-12-01; Completion date: 2011-07-01
Enrollment: 251 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a multicentre, open, randomised, parallel-group study with formoterol 9 μg one inhalation b.i.d, or standard COPD therapy. Standard (reference) COPD treatment arm should be the group to refer to when safety results of formoterol arm will be evaluated. 240 patients with moderate-to-severe COPD will be randomised (120 patients in the formoterol-arm and 120 patients on standard COPD therapy).

Detailed description:

Arms: arm 1: Formoterol 9 μg/dose
Interventions: intervention 1: Formoterol (OT)
Intervention descriptions: intervention 1: 9 μg/dose, Inhaled, twice daily for 52 weeks

Protocol documents:
Clinical trial NCT01047683
Conditions: Hypertriglyceridemia
Keywords: hypertriglyceridemia omega-3 fatty acids statin triglycerides lipids EPA docosahexaenoic acid fish fatty acids fibrates niacin lipid atorvastatin Lovaza simvastatin lovastatin pravastatin fluvastatin rosuvastatin Trilipix Vytorin Simcor ezetimibe Zetia ethyl-EPA ethyl icosapentate Crestor Zocor Lipitor Niaspan LDL HDL cholesterol dyslipidemia VASCEPA icosapent ethyl
Sponsor: Amarin Pharma Inc.
Start date: 2009-12-01; Completion date: 2011-07-01
Enrollment: 229 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: AMR101 (ethyl icosapentate) - 4 g/day intervention 2: AMR101 (ethyl icosapentate) - 2 g/day intervention 3: Placebo
Intervention descriptions: intervention 1: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12) intervention 2: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12) intervention 3: Placebo 4 capsules/day for 12 weeks (Weeks 1-12)

Protocol documents:
Clinical trial NCT01058096
Conditions: Bipolar Disorder Mania
Keywords: Acute Mania Bipolar I Disorder
Sponsor: Forest Laboratories
Start date: 2010-02-01; Completion date: 2011-07-01
Enrollment: 323 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.

Detailed description:

Arms: arm 1: Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks. arm 2: Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
Interventions: intervention 1: Cariprazine intervention 2: Placebo
Intervention descriptions: intervention 1: Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine. intervention 2: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo.

Protocol documents:
Clinical trial NCT01090310
Conditions: Non-infectious Uveitis
Keywords: Quiescent uveitis intermediate uveitis panuveitis posterior uveitis uveitis NVS Definition: Words or phrases that best describe the protocol. Keywords help users find studies in the database. Avoid acronyms, abbreviations and trade names. Examples: Heart failure, aliskiren, heart attack, cardiovascular diseases Psoriasis, inflammatory skin disease, scaly patches
Sponsor: Novartis Pharmaceuticals
Start date: 2010-08-01; Completion date: 2011-07-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This extension study will assess the safety and efficacy of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression

Detailed description:

Arms: arm 1: AIN457 300 mg subcutaneous (s.c.) weekly for 3 weeks followed by AIN457 300 mg s.c. every 2 weeks arm 2: AIN457 300 mg s.c. at baseline for Week 2 followed by AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly arm 3: AIN457 150 mg s.c. and placebo s.c. at Baseline and Week 2 followed by AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly arm 4: Placebo s.c. every 2 weeks
Interventions: intervention 1: AIN457 intervention 2: Placebo
Intervention descriptions: intervention 1: AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake intervention 2: Matching placebo to AIN457

Protocol documents:
Clinical trial NCT01092559
Conditions: Pulmonary Arterial Hypertension
Keywords: Diagnostic Techniques and Procedures
Sponsor: Geno LLC
Start date: 2010-10-01; Completion date: 2011-07-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label phase 2 pilot study designed to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during right heart catheterization (RHC) in participants with pulmonary arterial hypertension (PAH). All participants will receive inhaled nitric oxide in oxygen or nitric oxide in air delivered by nasal cannula. Hemodynamics, clinical laboratory and clinical assessment data will be collected on all participants to evaluate safety.

Detailed description:
TREATMENT/FOLLOW-UP:

Participants meeting eligibility criteria will receive open label nitric oxide at 80 ppm via a nasal cannula. Hemodynamic clinical laboratory and clinical assessment data will be collected at baseline, after 15 minutes of inhaled nitric oxide administration, post RHC procedure and at hospital discharge. Day 5 +/- 3 post RHC, telephone contact to assess general health status.

Arms: arm 1: Nitric Oxide via GeNO Nitrosyl system
Interventions: intervention 1: Nitric Oxide generated by the GeNO nitrosyl delivery system
Intervention descriptions: intervention 1: single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.

Protocol documents:
Clinical trial NCT01092663
Conditions: Diabetes Mellitus, Type 2
Keywords: Colesevelam type 2 diabetes sitagliptin glucose metabolism
Sponsor: KineMed
Start date: 2010-03-01; Completion date: 2011-07-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the effects of colesevelam, alone or in combination with sitagliptin, on glucose metabolism in subjects with T2DM inadequately controlled by diet and exercise

Detailed description:
The hypothesis is that co-administrationof colesevelam plus sitagliptin results in a greater reduction in HbA1c compared to colesevelam HCl treatment by

1. improving the effects of colesevelam on fasting glucose metabolism
2. improving the effects of colsevelam on postprandial glucose metabolism

Arms: arm 1: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks. arm 2: Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.

Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks.
Interventions: intervention 1: Colesevelam HCl intervention 2: Sitagliptin
Intervention descriptions: intervention 1: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks. intervention 2: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks.

Protocol documents:
Clinical trial NCT01102803
Conditions: Phobic Disorders
Keywords: Phobias Anxiety Disorders D-Cycloserine Phobic Disorders Mental Disorders Heights Acrophobia
Sponsor: Southern Methodist University
Start date: 2010-04-01; Completion date: 2011-07-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the utility of post-session administration of D-cycloserine to enhance fear extinction in a sample of people with acrophobia who will be treated with CBT.

Detailed description:

Arms: arm 1: Participants will receive placebo augmented cognitive behavioral therapy arm 2: Participants will receive D-Cycloserine augmented cognitive behavioral therapy
Interventions: intervention 1: Individual Cognitive Behavioral Therapy (CBT) intervention 2: D-Cycloserine intervention 3: Placebo
Intervention descriptions: intervention 1: The aim of CBT is to help participants become more comfortable with heights situations. Participants will receive 2 sessions over two weeks of individual CBT. intervention 2: D-Cycloserine intervention 3: Sugar Pill

Protocol documents:
Clinical trial NCT01103934
Conditions: Seasonal Allergic Rhinitis
Sponsor: University of Chicago
Start date: 2010-06-01; Completion date: 2011-07-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study would be to see if the addition of vitamin D to fluticasone propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis compared to fluticasone propionate treatment alone.

Detailed description:

Arms: arm 1: Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season arm 2: Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season
Interventions: intervention 1: Vitamin D3 intervention 2: Placebo intervention 3: Fluticasone Propionate
Intervention descriptions: intervention 1: 4000 IU once daily intervention 2: Placebo taken once daily intervention 3: 200 mcg daily, intranasal

Protocol documents:
Clinical trial NCT01112670
Conditions: Healthy
Keywords: Healthy volunteers
Sponsor: University of Colorado, Denver
Start date: 2009-11-01; Completion date: 2011-07-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the pharmacogenetics, pharmacokinetics, and drug-drug interactions of sitagliptin therapy.

Detailed description:

Arms: arm 1: ABCB1 CGC/CGC genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses arm 2: ABCB1 CGC/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses arm 3: ABCB1 TTT/TTT genetic make-up; sitagliptin 100 mg x 1 dose; atorvastatin 40 mg x 5 doses
Interventions: intervention 1: Sitagliptin intervention 2: atorvastatin
Intervention descriptions: intervention 1: sitagliptin 100 mg x 1 dose intervention 2: atorvastatin 40 mg x 5 doses

Protocol documents:
Clinical trial NCT01116895
Conditions: Psoriasis Vulgaris
Keywords: Psoriasis Vulgaris Systemic Anti-psoriatic
Sponsor: LEO Pharma
Start date: 2010-05-01; Completion date: 2011-07-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An international, multi-centre, prospective, randomised, double-blind, 4-arm, placebo controlled, parallel group study with 12 weeks once daily oral treatment in subjects with psoriasis vulgaris.

Detailed description:

Arms: arm 1: LEO 22811 0.5 mg: Oral solution arm 2: LEO 22811 1.5 mg: Oral solution arm 3: LEO 22811 3.0 mg: Oral solution arm 4: Placebo: Oral solution
Interventions: intervention 1: LEO 22811 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral solution intervention 2: Placebo

Protocol documents: