ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00348374
Conditions: Diabetes Mellitus
Keywords: type two diabetes, insulin, HbA1c
Sponsor: Pfizer
Start date: 2006-06-01; Completion date: 2008-08-01
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The current trial will examine the efficacy and safety of Exubera administered as a mealtime insulin compared to lispro, when added to an existing regimen of basal insulin glargine + or = Oral Agents (OAs). Dose titrations will be provided which should allow a large proportion of subjects to reach target glycosylated hemoglobin (A1C) levels.

Detailed description:

Arms: arm 1: Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents. arm 2: Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.
Interventions: intervention 1: Insulin Lispro intervention 2: Exubera
Intervention descriptions: intervention 1: Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents. intervention 2: Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.

Protocol documents:
Clinical trial NCT00360698
Conditions: Diabetes Mellitus, Type 2
Sponsor: Sanofi
Start date: 2006-07-01; Completion date: 2008-08-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.

Detailed description:

Arms: arm 1: Bolus arm arm 2: Control arm
Interventions: intervention 1: Insulin Glargine intervention 2: Glimepiride intervention 3: Insulin Glulisine intervention 4: Metformin
Intervention descriptions: intervention 1: One daily injection at bedtime intervention 2: At same dosage as during the run-in period intervention 3: One bolus given before the main meal intervention 4: At same dosage as during the run-in period

Protocol documents:
Clinical trial NCT00368745
Conditions: Generalized Anxiety Disorder
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-09-01; Completion date: 2008-08-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
GAD subjects maintained on a stable dose of alprazolam for at least four weeks who meet eligibility criteria will be randomized to receive pregabalin vs matching placebo while simultaneously tapering off of alprazolam over 6 weeks. Subjects return weekly for assessment of safety/tolerability of pregabalin vs placebo as well as for assessment of anxiety and benzodiazepine withdrawal symptoms. Subjects successfully able to discontinue alprazolam, will continue 6 weeks of treatment with pregabalin vs placebo (free of benzodiazepine use). The efficacy and safety of pregabalin vs placebo for anxiety symptoms and ability to discontinue/remain free of alprazolam will be compared among pregabalin and placebo treated groups. Hypothesis is that a greater proportion of subjects will be successful in discontinuing and remaining free from benzodiazepines who were treated with pregabalin as compared to subjects treated with placebo.

Detailed description:

Arms: arm 1: Pregabalin treatment for GAD during 6 week taper/discontinuation from alprazolam treatment; followed by 6 weeks pregabalin treatment 'alprazolam free'. arm 2: Placebo treatment of GAD during 6 week taper/discontinuation of alprazolam treatment followed by 6 weeks continuation of placebo treatment 'alprazolam free'.
Interventions: intervention 1: Pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: GAD subjects on stable dose of alprazolam will be randomized to double-blind pregabalin at starting dose of 75mg twice daily. Weekly assessments of tolerability, need for rescue medication, anxiety/withdrawal symptoms will guide flexible dose titration of pregabalin at dose range between 75 and 300mg twice daily. Subjects successful in discontinuation of alprazolam while treated with pregabalin will continue to be maintained on pregabalin for 6 weeks and assessed weekly for ability to remain in the study. intervention 2: GAD subjects on stable dose of alprazolam will be randomized to double-blind placebo matching assessments and study medication titration as detailed under the pregabalin arm description. Subjects successful in discontinuation of alprazolam while treated with placebo will continue to be maintained on placebo for 6 weeks and assessed weekly for ability to remain in the study.

Protocol documents:
Clinical trial NCT00374127
Conditions: Marijuana Dependence
Keywords: Marijuana Comparison between joints and blunts Pharmacokinetic effects
Sponsor: New York State Psychiatric Institute
Start date: 2004-12-01; Completion date: 2008-08-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate whether or not marijuana blunts will produce comparable plasma THC levels as marijuana joints and if blunts will produce larger cardiovascular and subjective effects.

Detailed description:
There has been a rapid increase in marijuana use during the 1990s, with the most recent generation often smoking marijuana in the form of 'blunts' as opposed to more traditional routes such as in pipes or in cigarette paper. A blunt is made by removing the tobacco from a cigar and replacing it with marijuana (Golub and Johnson, 1999). The cigar wrapper contains tobacco and nicotine, which may interact with the cardiovascular and subjective effects of the marijuana to produce a different set of effects and risks than cigarette paper. Anecdotally, marijuana smokers report that blunts are more potent than joints, yet there have been no controlled studies addressing whether blunts enhance the subjective-effects and health-related consequences of marijuana use. We are proposing to do a within-subject, placebo-controlled study directly comparing the cardiovascular, subjective and pharmacokinetic effects of marijuana smoked in blunts compared to identical quantities of marijuana smoked in cigarette paper. Research volunteers will be current blunt smokers. Each will participate in six, 4-hour outpatient sessions. After baseline data have been collected (heart rate, blood pressure, mood scales, exhaled carbon monoxide, plasma THC and nicotine levels), participants will take 3 puffs, 5 seconds in duration, from a NIDA marijuana cigarette containing 0.0, 1.8 and 3.6% THC or from a blunt containing an equivalent quantity and strength of marijuana. Participants will be blind to the type of marijuana cigarette smoked. We will measure plasma THC and nicotine, subjective mood ratings, and heart rate and blood pressure repeatedly over the course of 180 minutes following smoking. This study is the first controlled investigation of the consequences of this new method of marijuana smoking; the data obtained may be useful in guiding future development of marijuana pharmacotherapy.

Arms: arm 1: marijuana blunt (0%, 1.8%, or 3.6% THC) arm 2: marijuana cigarette (0%, 1.8%, or 3.6% THC)
Interventions: intervention 1: Marijuana blunt intervention 2: marijuana cigarette
Intervention descriptions: intervention 1: Blunts were fabricated by cutting the bottom third off a Dutch Master® cigar, removing all of the cigar tobacco, and replacing it with all of the marijuana contained in a NIDA marijuana cigarette (ca. 800 mg). intervention 2: Marijuana cigarettes were provided by the National Institute on Drug Abuse.

Protocol documents:
Clinical trial NCT00376259
Conditions: Hepatitis B
Keywords: lamivudine resistance Hepatitis B virus
Sponsor: Novartis
Start date: 2007-01-01; Completion date: 2008-08-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration \[FDA\] for the treatment of hepatitis B virus \[HBV\]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.

Detailed description:

Arms: arm 1: Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks. arm 2: Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
Interventions: intervention 1: telbivudine intervention 2: adefovir dipivoxil
Intervention descriptions: intervention 1: 600mg/day oral tablet for 96 weeks intervention 2: 10 mg of adefovir by mouth once daily

Protocol documents:
Clinical trial NCT00377234
Conditions: Post Menopausal Osteoporosis
Sponsor: Hoffmann-La Roche
Start date: 2006-05-01; Completion date: 2008-08-01
Enrollment: 356 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Risedronate intervention 2: ibandronate [Bonviva/Boniva]
Intervention descriptions: intervention 1: 35mg po weekly for 12 weeks intervention 2: 150mg po monthly for 3 months

Protocol documents:
Clinical trial NCT00383552
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2006-09-01; Completion date: 2008-08-01
Enrollment: 746 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, participants will receive open-label (OL) MF MDI 100 mcg twice daily (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by the Area Under the Curve from 0 to 12 hours \[AUC\](0-12 hours) of the change from Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) and by the time-to-first severe asthma exacerbation across the 26-week treatment period.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID intervention 2: Mometasone Furoate MDI (MF MDI) intervention 3: Formoterol Fumarate 10 mcg intervention 4: Placebo
Intervention descriptions: intervention 1: MF/F 100/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks intervention 2: MF 100 mcg via metered dose inhaler twice daily for 26 weeks intervention 3: F via metered dose inhaler 10 mcg twice a day for 26 weeks intervention 4: Placebo metered dose inhaler twice a day for 26 weeks

Protocol documents:
Clinical trial NCT00391027
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes, insulin, glycemic control
Sponsor: Pfizer
Start date: 2006-12-01; Completion date: 2008-08-01
Enrollment: 261 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Insulin Glargine (Lantus®) intervention 2: Inhaled Human Insulin (Exubera®)
Intervention descriptions: intervention 1: Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents. intervention 2: Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.

Protocol documents:
Clinical trial NCT00396409
Conditions: Allergic Asthma
Sponsor: Novartis Pharmaceuticals
Start date: 2006-02-01; Completion date: 2008-08-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid seasonal allergic rhinoconjunctivitis.

Detailed description:
This was an open-label extension period of the previously randomized, multicenter, double-blind, placebo-controlled, parallel-group trial to demonstrate the benefit of pre- and co-seasonal combination therapy with anti-IgE (omalizumab) and specific immunotherapy (Depigoid) in patients with seasonal allergic asthma and co-morbid seasonal allergic rhinoconjunctivitis. During the open-label period, all patients received Depigoid monotherapy for two follow-up seasons every 4 weeks, 26 injections in total. The extension period was performed to evaluate the influence of omalizumab on the follow-up treatment with Depigoid in seasonal asthma.

This study was a follow-up to the core IGE025ADE03 study, in which patients received omalizumab treatment. In this follow-up study, no patient received omalizumab.

Arms: arm 1: Xolair® (Omalizumab, double-blind core study period only), Depigoid® (grass/rye pollen 50/50) arm 2: Depigoid® (grass/rye pollen 50/50) + Placebo
Interventions: intervention 1: Depigoid intervention 2: Omalizumab intervention 3: Placebo
Intervention descriptions: intervention 1: Administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL) intervention 2: anti-IgE (Omalizumab) given during the 2006 core study intervention 3: Placebo given during the 2006 core study

Protocol documents:
Clinical trial NCT00410514
Conditions: Lower Urinary Tract Symptoms Bladder Outlet Obstruction
Keywords: Beta-3 Receptor Agonist YM178 Men Lower Urinary Tract Symptoms Bladder Outlet Obstruction
Sponsor: Astellas Pharma Inc
Start date: 2006-12-01; Completion date: 2008-08-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study examined the safety, tolerability, and efficacy of mirabegron (YM178) compared to placebo.

Detailed description:

Arms: arm 1: Participants received matching mirabegron placebo tablets orally once daily for 12 weeks. arm 2: Participants received 50 mg mirabegron tablets orally once daily for 12 weeks. arm 3: Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
Interventions: intervention 1: Mirabegron intervention 2: Placebo
Intervention descriptions: intervention 1: oral intervention 2: oral

Protocol documents:
Clinical trial NCT00413062
Conditions: Contraception
Sponsor: Organon and Co
Start date: 2006-06-01; Completion date: 2008-08-01
Enrollment: 2281 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.

Detailed description:

Arms: arm 1: Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive arm 2: Drospirenone (DRSP) and Ethinyl Estradiol (EE), 3 mg DRSP and 30 mcg EE monophasic combined oral contraceptive
Interventions: intervention 1: NOMAC-E2 intervention 2: DRSP-EE
Intervention descriptions: intervention 1: Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year). intervention 2: Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).

Protocol documents:
Clinical trial NCT00413660
Conditions: Arthritis, Rheumatoid
Keywords: DMARD therapy
Sponsor: Pfizer
Start date: 2007-01-01; Completion date: 2008-08-01
Enrollment: 509 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness and safety, over 6 months, of 6 dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults with active rheumatoid arthritis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: Dummy tablets
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550 intervention 5: CP-690,550 intervention 6: CP-690,550 intervention 7: placebo
Intervention descriptions: intervention 1: 4 blinded tablets administered BID intervention 2: 4 blinded tablets administered BID intervention 3: 4 blinded tablets administered BID intervention 4: 4 blinded tablets administered BID intervention 5: 4 blinded tablets administered BID intervention 6: Oral tablets intervention 7: Placebo

Protocol documents:
Clinical trial NCT00425945
Conditions: Hypertension
Sponsor: Stanford University
Start date: 2006-10-01; Completion date: 2008-08-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy of Flavangenol® (Toyo Shinyaku, Japan), a pine bark extract, in lowering blood pressure and improving glycemic control and plasma lipoprotein profile.

Detailed description:
Cardiovascular disease is the number one cause of death in the Unites States. Our study tests the efficacy of pine bark extract in improving a number of cardiovascular disease risk factors. We are conducting a randomized, placebo-controlled, double-blind, parallel trial that will investigate the efficacy and safety of Flavangenol® (Toyo Shinyaku, Japan), a pine bark extract, among 130 study participants. These participants will be individuals at mildly or moderately elevated risk of cardiovascular disease (CVD) because of having prehypertension, excess body weight, and insulin insensitivity. We aim to determine (in order of priority):

1. The efficacy of Flavangenol in lowering blood pressure.
2. The efficacy of Flavangenol in improving glycemic control and plasma lipoprotein profile.
3. Changes in body weight, antioxidative capacity, anti-inflammatory markers, blood coagulation factors, and liver function tests in response to Flavangenol.
4. The safety of Flavangenol, as confirmation of past studies.

Arms: arm 1: Placebo delivered as four tablets matching the active product once daily orally. arm 2: Flavangenol 200 mg Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets, each containing 50 mg Flavangenol, all 4 tablets taken once per day.
Interventions: intervention 1: Pine Bark Extract (Flavangenol®)
Intervention descriptions: intervention 1: Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.

Dosage delivered as four tablets, each containing 50 mg Flavangenol, all 4 tablets taken once per day orally for 12 weeks.

Protocol documents:
Clinical trial NCT00430027
Conditions: Esophageal Adenocarcinoma
Keywords: Esophageal Esophagus
Sponsor: University of Colorado, Denver
Start date: 2006-11-01; Completion date: 2008-08-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this pilot study is to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection \[and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab\] is feasible and tolerable.

Detailed description:
It is clear that new approaches are needed to improve the therapeutic ratio in esophageal cancer. This study proposes to evaluate the novel combination of preoperative capecitabine, oxaliplatin, and cetuximab concurrently with radiation therapy. This will be followed by esophagectomy 6-9 weeks after the completion of chemoradiation. Followed by further adjuvant chemotherapy. It is hypothesized that our novel combination of neoadjuvant capecitabine, oxaliplatin, and cetuximab combined with thoracoabdominal radiation therapy will be feasible and result in acceptable toxicity.

Arms: arm 1: Patients enrolled on the trial will receive neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This will be followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
Interventions: intervention 1: Capecitabine intervention 2: Oxaliplatin intervention 3: Cetuximab
Intervention descriptions: intervention 1: Given 650 mg/m\^2 BID on days of ration therapy, 825 mg/m\^2 day 1-14, day 15-20 off x 4 intervention 2: Oxaliplatin 30 mg/m\^2, 130mg/m2 IV Q 21 days x 4 intervention 3: Initial Cetuximab 400 mg/m\^2 IV starting no earlier than 8 weeks and no later than 10 weeks after surgical resection

Protocol documents:
Clinical trial NCT00447122
Conditions: Metastatic Pancreatic Cancer
Keywords: Pancreatic Cancer
Sponsor: Brown University
Start date: 2007-03-01; Completion date: 2008-08-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
Phase I study of lapatinib and gemcitabine for patients with metastatic pancreaticobiliary cancer.

Detailed description:
To evaluate the safety/tolerability and potential antitumor activity of lapatinib, at dose ranges of 1000 to 1500 mg/d, in combination with gemcitabine and gemcitabine/oxaliplatin (GEMOX) in patients with advanced pancreaticobiliary cancer.

Arms: arm 1: Gemcitabine 1000mg/m2 with lapatinib 1000mg/d weekly x 3 weeks arm 2: Gemcitabine 1000mg/m2 with lapatinib 1500mg/d weekly X 3 weeks arm 3: gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 on days 1 and 14 of a 28-day cycle with lapatinib 1000 mg/d arm 4: gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 on days 1 and 14 of a 28-day cycle with lapatinib 1500 mg/d
Interventions: intervention 1: Gemcitabine 1000mg/m2 30 minutes intervention 2: Lapatinib 1000mg/d intervention 3: Lapatinib 1500mg/d intervention 4: Gemcitabine 1000mg/m2 100minutes intervention 5: Oxaliplatin 100mg/m2
Intervention descriptions: intervention 1: 1000mg/m2 30 minutes intervention 2: 1000mg/d intervention 3: 1500mg/d intervention 4: 1000mg/m2 100minutes intervention 5: 100mg/m2

Protocol documents: