ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00383721
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Organon and Co
Start date: 2006-09-01; Completion date: 2010-07-01
Enrollment: 1196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic obstructive pulmonary disease (COPD). All placebo-treated subjects and active-treated subjects who will not participate in the safety extension will be discontinued and will have their Final Visit at Week 26. Subjects who continue into the 26-week safety extension will have their Final Visit at Week 52. Efficacy will be measured by the mean change from Baseline to Week 13 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours (FEV1 AUC\[0-12hr\]) and change from Baseline to Week 13 in AM predose FEV1.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Mometasone furoate/formoterol (MF/F) combination intervention 2: Mometasone furoate/formoterol (MF/F) combination intervention 3: Mometasone furoate MDI (MF MDI) intervention 4: Formoterol MDI intervention 5: Placebo
Intervention descriptions: intervention 1: MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks intervention 2: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks intervention 3: MF 400 mcg via metered dose inhaler twice daily for 52 weeks intervention 4: Formoterol 10 mcg via metered dose inhaler twice a day for 52 weeks intervention 5: Placebo MDI twice a day for 26 weeks

Protocol documents:
Clinical trial NCT00391443
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: BUILD 3 Idiopathic Pulmonary Fibrosis Tracleer Interstitial Lung Disease bosentan Actelion
Sponsor: Actelion
Start date: 2007-02-01; Completion date: 2010-07-01
Enrollment: 616 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
BUILD 3 is a prospective, multicenter, randomized, double-blind, parallel group, placebo-controlled, event-driven, group sequential, phase III superiority study. The primary objective is to demonstrate that bosentan delays disease worsening or death in patients with Idiopathic Pulmonary Fibrosis.

Detailed description:

Arms: arm 1: Subjects receive bosentan 62.5 mg twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg b.i.d (if body weight \> 40 kg) or bosentan 62.5 mg b.i.d. (if body weight \< 40 kg) arm 2: Subjects receive placebo matching the bosentan treatment regimen
Interventions: intervention 1: Bosentan intervention 2: Placebo
Intervention descriptions: intervention 1: Bosentan 62.5 mg tablets twice daily (b.i.d.) for 4 weeks followed by bosentan 125 mg tablets b.i.d (if body weight \> 40 kg) or bosentan 62.5 mg tablets b.i.d. (if body weight \< 40 kg) intervention 2: Placebo matching bosentan 62.5 mg tablets and 125 mg tablets

Protocol documents:
Clinical trial NCT00415636
Conditions: Cancer
Sponsor: Eli Lilly and Company
Start date: 2007-01-01; Completion date: 2010-07-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.

Detailed description:

Arms: arm 1: LY2603618 40 milligrams per square meter (mg/m\^2) was administered over the duration of 4.5 hours (30-minute bolus followed by a 4-hour infusion). Dose modifications were not allowed. arm 2: Based on pharmacokinetic (PK) data from Cohort 1 (LY2603618 40 mg/m\^2 \[4.5-hour infusion\]), the LY2603618 40 mg/m\^2 dose in Cohort 2 (LY2603618 40 mg/m\^2 \[1-hour infusion\]) was repeated, but the dose was administered over the duration of 1 hour. Dose modifications were not allowed. arm 3: Beginning with Cohort 3 (LY2603618 70 mg/m\^2), dose modifications were allowed. LY2603618 70 mg/m\^2 was administered over the course of 1 hour. arm 4: Cohort 4: LY2603618 105 mg/m\^2 administered over the duration of 1 hour. arm 5: Cohort 5: LY2603618 150 mg/m\^2 administered over the duration of 1 hour. arm 6: Cohort 6: LY2603618 195 mg/m\^2 administered over the duration of 1 hour.
Interventions: intervention 1: IC83/LY2603618 intervention 2: IC83/LY2603618 intervention 3: IC83/LY2603618 intervention 4: IC83/LY2603618 intervention 5: IC83/LY2603618 intervention 6: pemetrexed intervention 7: pemetrexed
Intervention descriptions: intervention 1: 40 mg/m\^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles. Dose finding study: dose is escalated after a minimum of 6 participants receive 40 mg/m\^2. intervention 2: 70 mg/m\^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles. intervention 3: 105 mg/m\^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles. intervention 4: 150 mg/m\^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles. intervention 5: 195 mg/m\^2 Day 1 and Day 9 of Cycle 1, Day 2 of subsequent cycles, unlimited 21-day cycles. intervention 6: pemetrexed 500 mg/m\^2, intravenous (IV), Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles intervention 7: pemetrexed 500 mg/m\^2 IV, Day 8 of Cycle 1, Day 1 of subsequent cycles, unlimited 21-day cycles

Protocol documents:
Clinical trial NCT00417170
Conditions: High Blood Pressure Metabolic Syndrome Insulin Resistance Endothelial Dysfunction
Keywords: High Blood pressure Hypertension metabolic syndrome insulin resistance endothelial dysfunction pre-diabetic amlodipine, aliskiren, IGT, IFG, MBF
Sponsor: Novartis Pharmaceuticals
Start date: 2007-10-01; Completion date: 2010-07-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine the effects of Aliskiren on insulin resistance (IR) and endothelial dysfunction (ED) in patients with high blood pressure and metabolic syndrome. The efficacy of Aliskiren was compared to Amlodipine.

Detailed description:

Arms: arm 1: Eligible participants received oral Aliskiren 300 mg + Placebo Amlodipine once daily for 12 weeks. Study medication was taken with 200 mL of water in the morning. Breakfast was eaten 1 hour after taking study medication. Study medication was swallowed whole, and not chewed. arm 2: Eligible participants received oral Amlodipine 5 mg + Placebo Aliskiren once daily for 12 weeks. Study medication was taken with 200 mL of water in the morning. Breakfast was eaten 1 hour after taking study medication. Study medication was swallowed whole, and not chewed.
Interventions: intervention 1: Aliskiren intervention 2: Amlodipine intervention 3: Placebo Aliskiren intervention 4: Placebo Amlodipine
Intervention descriptions: intervention 1: Aliskiren 300 mg tablets taken orally once daily intervention 2: Amlodipine 5 mg capsule taken orally once daily intervention 3: Placebo Aliskiren taken orally once daily. intervention 4: Placebo Amlodipine taken orally once daily

Protocol documents:
Clinical trial NCT00429403
Conditions: Breast Cancer
Keywords: Breast Cancer Chemotherapy Ovarian Function Goserelin Zoladex Ovary function Fertility Early Menopause
Sponsor: M.D. Anderson Cancer Center
Start date: 2006-08-01; Completion date: 2010-07-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

* To determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing neoadjuvant and/or adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses.

Secondary Objectives:

* To determine the incidence of pregnancy and the effect for participants' quality of life (QOL) after chemotherapy.
* To determine the overall survival and disease-free survival times of study participants.

Detailed description:
Goserelin is designed to block hormones that can regulate your menstruation by affecting the pituitary gland (part of brain).

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of two treatment groups. You will either be assigned to receive goserelin or no treatment. There is an equal chance of being assigned to either group.

If you are assigned to receive goserelin, the first dose will be given as an injection under the skin, 1 week before you start chemotherapy. You will then receive chemotherapy as part of your standard of care. Following the first dose of goserelin, you will be given a goserelin injection into the skin, once a month until 3 weeks after the last chemotherapy dose.

You will be taken off study if intolerable side effects occur during this study. After you are finished with chemotherapy, you will have a series of follow-up visits. During the period of follow-up, you will have a medical history, physical exam, and blood tests (2-3 teaspoons) to evaluate your ovarian function, every 3 months for 1 year and then at 24 months. You will be asked to fill out questionnaires about your menstrual history at these visits. The questionnaires should take about 15 minutes to complete. You will be also asked to fill out questionnaires about your quality of life at 12 and 24 months. The questionnaires should take about 30 minutes to complete.

This is an investigational study. Goserelin is commercially available and has been approved by the FDA for use in breast cancer patients. Its use in this study is investigational. About 148 patients will take part in this multicenter study. Up to 36 patients will be enrolled at M.D. Anderson.

Arms: arm 1: 3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy. arm 2: None
Interventions: intervention 1: Goserelin
Intervention descriptions: intervention 1: 3.6 mg subcutaneous injection 1 week before the start of chemotherapy, then once a month until 3 weeks after the last chemotherapy dose.

Protocol documents:
Clinical trial NCT00440947
Conditions: Infection, Human Immunodeficiency Virus I HIV Infection
Keywords: NORVIR ARIES EPZICOM REYATAZ HIV simplification Antiretroviral-naive
Sponsor: ViiV Healthcare
Start date: 2007-03-01; Completion date: 2010-07-01
Enrollment: 515 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC) Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by randomization to either a simplification regimen of ATV or continuation of ATV +/r for an additional 48 weeks, each in combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1 infected, HLA-B\*5701 negative subjects.

All subjects who complete the 84-week study will be eligible to enter the treatment extension phase and continue for an additional 60 weeks. The purpose of this extension is to obtain longer term treatment data in subjects who have completed the 84-week study.

Detailed description:
Safety and Efficacy of an Initial Regimen of Atazanavir (ATV) + Ritonavir (/r) + the Abacavir/Lamivudine Fixed-Dose Combination Tablet (ABC/3TC FDC) for 36 weeks followed by Simplification to Atazanavir with ABC/3TC FDC or Maintenance of the Initial Regimen for an Additional 48 weeks in Antiretroviral-Naive HIV-1 Infected HLA-B\*5701 Negative Subjects followed by an Optional 60-Week Treatment Extension Phase

Arms: arm 1: Atazanavir (ATV) 400 mg QD + abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) QD for 48 weeks followed by optional treatment extension for 60 weeks on the same regimen. arm 2: Atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD + abacavir (ABC) 600mg/lamivuidine (3TC )300 mg FDC QD for 48 weeks followed by optional treatment extension for 60 weeks on the same regimen.
Interventions: intervention 1: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r) intervention 2: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV)
Intervention descriptions: intervention 1: Abacavir (ABC)/lamivudine (3TC) FDC + atazanavir (ATV)+ ritoanvir (/r) for 36weeks followed by ABC/3TC + ATV + /r for 48wks followed by optional treatment extension for 60 weeks on the same regimen intervention 2: Abacavir (ABC)/lamivudine (3TC) FDC + atazanavir (ATV) + ritonavir (/r) for 36 weeks followed by ABC/3TC + ATV for 48wks followed by optional treatment extension for 60 weeks on the same regimen

Protocol documents:
Clinical trial NCT00445770
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis Arthritis
Sponsor: Pfizer
Start date: 2006-07-01; Completion date: 2010-07-01
Enrollment: 550 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared with methotrexate (up to 8 mg per week) on the slowing of joint destruction.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Etanercept intervention 2: Etanercept intervention 3: Methotrexate
Intervention descriptions: intervention 1: 10 mg twice weekly, subcutaneous injection for 52 weeks intervention 2: 25 mg, twice weekly, subcutaneous injection for 52 weeks intervention 3: up to 8 mg per week, oral dosing for 52 weeks

Protocol documents:
Clinical trial NCT00454636
Conditions: Gastric Cancer
Sponsor: Hoffmann-La Roche
Start date: 2007-03-01; Completion date: 2010-07-01
Enrollment: 158 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of Xeloda, given in combination with standard chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy regimens; the dose of Xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the chemotherapy regimen used. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks. arm 2: Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks. arm 3: Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks. arm 4: Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
Interventions: intervention 1: Cisplatin intervention 2: Capecitabine intervention 3: Epirubicin intervention 4: Cisplatin intervention 5: Capecitabine intervention 6: Oxaliplatin intervention 7: Docetaxel intervention 8: Capecitabine
Intervention descriptions: intervention 1: 80 mg/m2/day, intravenous (IV), every 3 weeks intervention 2: 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle intervention 3: 50 mg/m2/day, IV, every 3 weeks intervention 4: 60 mg/m2/day, IV, every 3 weeks intervention 5: 625 mg/m2, oral, twice daily per 3-week cycle intervention 6: 130 mg/m2/day, IV, every 3 weeks intervention 7: 60 mg/m2/day, IV, every 3 weeks intervention 8: 825 mg/m2, oral, twice daily for 2 weeks

Protocol documents:
Clinical trial NCT00459290
Conditions: Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer
Keywords: recurrent ovarian epithelial cancer primary peritoneal cavity cancer fallopian tube cancer
Sponsor: Gynecologic Oncology Group
Start date: 2007-05-01; Completion date: 2010-07-01
Enrollment: 24 participants; Allocation: ; Intervention model: 

Brief summary:
RATIONALE: Progesterone can cause the growth of ovarian epithelial cancer , primary peritoneal cancer, or fallopian tube cancer. Hormone therapy using mifepristone may fight ovarian epithelial cancer and primary peritoneal cancer by lowering the amount of progesterone the body makes.

PURPOSE: This phase II trial is studying the side effects and how well mifepristone works in treating patients with recurrent or persistent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the antitumor activity of mifepristone in patients with recurrent or persistent ovarian epithelial, primary peritoneal, or fallopian tube carcinoma.
* Determine the toxicity of this drug in these patients.

Secondary

* Determine the duration of progression-free survival and overall survival of patients treated with this drug.
* Determine the potential impact of platinum sensitivity, initial performance status, and age on prognosis in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral mifepristone once daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.

Arms: arm 1: Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks is considered one cycle) until disease progression or adverse effects prohibit further therapy.
Interventions: intervention 1: mifepristone
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00469898
Conditions: Lung Cancer
Keywords: extensive stage small cell lung cancer
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2003-12-01; Completion date: 2010-07-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: The general results of combining irinotecan and platin-based chemotherapies have been very encouraging. As the toxicity profile associated with carboplatin is preferable over cisplatin it is our expectation that patients and physicians would prefer to use this combination if it is equally or more efficacious. To date there has been no agreement regarding the optimal combination of these agents. Based on the trials described in the protocol and our experience with carboplatin/irinotecan in the treatment of non-small cell lung cancer the present trial will utilize a 21-day cycle of irinotecan 50 mg/m2 given on days 1 and 8 and carboplatin AUC 5 (based on the Calvert formula) on day 1.

PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works as first-line therapy in treating patients with extensive-stage small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* To examine the anti-tumor efficacy of the combination of Irinotecan (CPT-11) and Carboplatin as first-line therapy as assessed by response rate in patients with chemo-naïve extensive stage small cell lung cancer.

Secondary

* Determine the safety, tolerability, and feasibility of this regimen in these patients.
* Determine the time to progression in patients treated with this regimen.
* Determine the overall survival of patients treated with this regimen.

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

Patients receive irinotecan IV over 30-90 minutes on days 1 and 8 and carboplatin IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

Arms: arm 1: Lung cancer patients will be treated for four 3-week cycles (12 weeks) in the absence of progressive disease, unacceptable toxicity, or withdrawal of patient consent. Up to two additional cycles may be administered at the discretion of the treating physician. If at treatment withdrawal the disease has responded or is stable, the patient will continue to be followed for efficacy (i.e. until progressive disease)at 8 week intervals. Following the diagnosis of progressive disease, patients will be followed every two months for survival.
Interventions: intervention 1: Carboplatin intervention 2: irinotecan hydrochloride
Intervention descriptions: intervention 1: Carboplatin dosage calculation to be given on day 1, every 21 days:

Carboplatin (mg) = (AUC of 5) x (GFR + 25)

\*up to 6 cycles at physician's discretion intervention 2: 50 mg/m2 IV on days 1 and 8 every 21 days

Should be infused IV over 30- 90 minutes.

Protocol documents:
Clinical trial NCT00510146
Conditions: Depression, Bipolar
Sponsor: Eli Lilly and Company
Start date: 2007-08-01; Completion date: 2010-07-01
Enrollment: 514 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess whether olanzapine is superior to placebo in patients with bipolar depression.

Detailed description:
1. Dose range and administration mode: Oral Olanzapine 5mg - 20mg/day
2. Duration:

   1. Screening phase is 2-28 days.
   2. Double-blind treatment phase is 6 weeks
   3. Open-label extension phase is 18 weeks

Arms: arm 1: During double-blind treatment, participants receive olanzapine at a dose of 5 milligram (mg) which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation. arm 2: Matching placebo administered once daily, by mouth during double-blind treatment. arm 3: During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and Week 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
Interventions: intervention 1: Olanzapine intervention 2: Placebo
Intervention descriptions: intervention 1: 5-20 mg, oral, once daily, for 24 weeks (participants randomized to olanzapine in double-blind treatment period) or 18 weeks (participants randomized to placebo in double-blind treatment period). intervention 2: placebo tablets, oral, once daily at bedtime, 6 weeks

Protocol documents:
Clinical trial NCT00516139
Conditions: Epilepsy
Keywords: Epilepsy elderly seizure
Sponsor: GlaxoSmithKline
Start date: 2007-08-01; Completion date: 2010-07-01
Enrollment: 122 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is being conducted to determine the safety and tolerability of lamotrigine (LTG) in elderly patients with epilepsy. This study will be carried out using an extended-release formulation of lamotrigine (LTG-XR) that will allow once-a-day dosing.

Detailed description:

Arms: arm 1: Open-label lamotrigine
Interventions: intervention 1: Lamotrigine
Intervention descriptions: intervention 1: Open-label

Protocol documents: