ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01457339
Conditions: Schizophrenia
Keywords: Schizophrenia
Sponsor: Shire
Start date: 2011-10-21; Completion date: 2012-01-20
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multiple ascending dose study; the purpose of this study is to examine the safety, tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic Patients who are currently maintained on a stable dose of an antipsychotic medication.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SPD489 (Lisdexamfetamine dimesylate) intervention 2: Placebo
Intervention descriptions: intervention 1: SPD489 administered orally in ascending doses (50mg, 70mg, 100mg, 150mg, 200mg, 250mg). Each of these doses will be administered once daily for 5 days. Total number of days dosed is 30 days. intervention 2: Placebo Capsule(s) for oral use taken once daily for 30 days

Protocol documents:
Clinical trial NCT01323621
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: GlaxoSmithKline
Start date: 2011-03-18; Completion date: 2012-01-24
Enrollment: 512 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.

Detailed description:
This is a randomized, double-blind, double-dummy, multi-centre parallel group study. Subjects who meet the eligibility criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment period. There will be a 7-day Follow-up period after the treatment period.

Arms: arm 1: Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA) arm 2: Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA)
Interventions: intervention 1: Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg intervention 2: Fluticasone Propionate 250mcg / salmeterol 50mcg intervention 3: Double-dummy placebo intervention 4: Salbutamol as needed
Intervention descriptions: intervention 1: inhalation powder intervention 2: inhalation powder intervention 3: inhalation powder intervention 4: inhalation powder

Protocol documents:
Clinical trial NCT01370655
Conditions: Hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-06-15; Completion date: 2012-01-26
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is being done to evaluate the antihypertensive efficacy and tolerability of MK-7145 in participants with mild-to-moderate hypertension.

The primary hypotheses for the study were as follows:

1. Multiple dose administration of 6-mg MK-7145 results in a reduction in systolic blood pressure (SBP) in male participants with mild to moderate hypertension that is superior to placebo, as measured by time weighted average change from baseline over 24 hours postdose (TWA0-24hrs) on dosing Day 28
2. Multiple dose administration of 6-mg MK-7145 results in a reduction in SBP in male participants with mild to moderate hypertension that is similar to hydrochlorothiazide (HCTZ), as measured by TWA0-24hrs on dosing Day 28
3. The effect of MK-7145 and HCTZ on natriuresis (UNaV) as well as SBP and diastolic blood pressure (DBP), both as measured by TWA0-24hrs, will be estimated
4. Multiple dose administration of MK-7145 for 4 weeks will be generally safe and well-tolerated.

Detailed description:

Arms: arm 1: MK-7145 3 mg (three x 1-mg MK-7145 capsules administered orally) and placebo to HCTZ (two 12.5-mg capsules) then three x 1-mg MK-7145 capsules 4 hours later, daily for 4 weeks. arm 2: MK-7145 3 mg (one 2mg MK-7145 and one MK-7145 placebo capsule) then one 1-mg MK-7145 capsule and two MK-7145 placebo capsules 4 hours later and placebo to HCTZ (2 capsules once daily) daily for 4 weeks. arm 3: HCTZ 25 mg (two 12.5-mg capsules) and placebo to MK-7145 (one 3-mg capsule) then placebo for MK-7145 (one 3-mg capsule) 4 hours later daily for 4 weeks. arm 4: Placebo to MK-7145 (2 x 3-mg capsules) and placebo to HCTZ 25 mg (2 capsules) then placebo to MK-7145 (2 x 3-mg capsules) 4 hours later daily for 4 weeks
Interventions: intervention 1: MK-7145 intervention 2: Hydrochlorothiazide (HCTZ) intervention 3: Placebo to MK-7145 intervention 4: Placebo to HCTZ
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01057693
Conditions: Diabetic Neuropathy, Painful
Keywords: Diabetic peripheral neuropathy Lyrica pregabalin pain
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2010-03-31; Completion date: 2012-01-30
Enrollment: 633 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: pregabalin (Lyrica) intervention 2: Placebo
Intervention descriptions: intervention 1: Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily. intervention 2: Placebo is supplied as capsules and given 3 times daily.

Protocol documents:
Clinical trial NCT01291173
Conditions: Binge Eating Disorder
Sponsor: Shire
Start date: 2011-05-10; Completion date: 2012-01-30
Enrollment: 271 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of SPD489 compared to placebo in the treatment of moderate to severe binge eating disorder as measured by the number of binge days per week

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: lisdexamfetamine dimesylate (SPD489) intervention 2: lisdexamfetamine dimesylate (SPD489) intervention 3: lisdexamfetamine dimesylate (SPD489) intervention 4: Placebo
Intervention descriptions: intervention 1: SPD489-30mg capsules taken once daily for up to 11 weeks intervention 2: SPD489 50mg capsules taken once-daily for up to 11 weeks intervention 3: SPD489 70mg capsule taken once-daily for up to 11 weeks intervention 4: Placebo capsule taken once daily for up to 11 weeks

Protocol documents:
Clinical trial NCT00765999
Conditions: Chronic Constipation Irritable Bowel Syndrome With Constipation
Keywords: Constipation Chronic Constipation Irritable Bowel Syndrome With Constipation Linaclotide
Sponsor: Forest Laboratories
Start date: 2008-10-31; Completion date: 2012-01-31
Enrollment: 1559 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).

Detailed description:

Arms: arm 1: Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with either CC or IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.
Interventions: intervention 1: Linaclotide
Intervention descriptions: intervention 1: Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.

Protocol documents:
Clinical trial NCT00369941
Conditions: HIV Infections
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-08-01; Completion date: 2012-02-01
Enrollment: 566 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected patients not previously treated.

Detailed description:

Arms: arm 1: MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min. arm 2: Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
Interventions: intervention 1: MK-0518 intervention 2: Comparator: efavirenz intervention 3: Comparator: Truvada intervention 4: Comparator: Placebo to MK-0518 intervention 5: Comparator: Placebo to efavirenz
Intervention descriptions: intervention 1: 400 mg MK-0518 tablet taken by mouth (PO) twice a day (b.i.d.) for up to 240 weeks intervention 2: 600 mg efavirenz tablet taken by mouth (PO) every night (q.h.s.) for up to 240 weeks intervention 3: One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir) intervention 4: Placebo to MK-0518 PO b.i.d., taken for up to 240 weeks intervention 5: Placebo to efavirenz PO every night (q.h.s.), taken for up to 240 weeks

Protocol documents:
Clinical trial NCT00549302
Conditions: Hypertension, Pulmonary
Sponsor: Eli Lilly and Company
Start date: 2005-12-01; Completion date: 2012-02-01
Enrollment: 357 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to determine the long term safety of tadalafil in patients with increased blood pressure in the blood vessel that carries blood from the right heart to the lungs and to see if it will keep the disease from getting worse.

Detailed description:

Arms: arm 1: 20 milligram (mg) tadalafil taken once a day arm 2: 40 mg tadalafil tablet taken once a day
Interventions: intervention 1: tadalafil intervention 2: tadalafil
Intervention descriptions: intervention 1: 20 milligram (mg) tablet, taken by mouth once a day for 52 weeks for the phase 1 portion. Open label phase includes 40 mg tablet taken by mouth once a day until the sponsor concludes the study or tadalafil becomes commercially available for the treatment of Pulmonary Arterial Hypertension (PAH). intervention 2: 40 mg tablet taken by mouth once a day for 52 weeks in phase 1. Open label phase includes 40 mg tablet taken by mouth once a day until the sponsor concludes the study or tadalafil becomes commercially available for the treatment of PAH.

Protocol documents:
Clinical trial NCT00602030
Conditions: Non-Small-Cell Lung Carcinoma Carcinoma, Non-Small Cell Lung
Keywords: lung cancer NSCLC lung neoplasms respiratory
Sponsor: Syndax Pharmaceuticals
Start date: 2008-01-08; Completion date: 2012-02-01
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of entinostat in combination with erlotinib in the treatment of Advanced Non-Small Cell Lung Cancer (NSCLC).

Detailed description:

Arms: arm 1: Erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase. arm 2: Erlotinib 150 mg tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase. arm 3: Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase. arm 4: Erlotinib 150 mg, tablets, orally, daily plus placebo matching entinostat, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase. arm 5: Participants in the Double-blind Phase Erlotinib + Placebo arm who experienced disease progression crossed over to receive open-label erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities.
Interventions: intervention 1: Entinostat intervention 2: Placebo intervention 3: Erlotinib
Intervention descriptions: intervention 1: Entinostat tablets on Days 1 and 15 of a 28-day cycle. intervention 2: Placebo-matching entinostat tablets on Days 1 and 15 of a 28-day cycle. intervention 3: Erlotinib 150 mg tablets once daily.

Protocol documents:
Clinical trial NCT00796757
Conditions: Renal Cell Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-12-01; Completion date: 2012-02-01
Enrollment: 146 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess progression free survival, tumor response and safety of Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every 2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week (t.i.w.). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: interferon alfa-2a
Intervention descriptions: intervention 1: 10mg/kg iv infusion every 2 weeks intervention 2: 3 MIU sc t.i.w.

Protocol documents:
Clinical trial NCT01152554
Conditions: Major Depressive Disorder MDD Depression
Keywords: Major Depressive Disorder MDD Depression Safety add-on therapy
Sponsor: AstraZeneca
Start date: 2010-06-01; Completion date: 2012-02-01
Enrollment: 813 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken for 52 weeks with another antidepressant medicine.

Detailed description:

Arms: arm 1: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214 1-4 mg BID arm 2: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + placebo BID
Interventions: intervention 1: TC-5214 intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet, oral, twice daily for 52 weeks intervention 2: Tablet, oral, twice daily for 52 weeks

Protocol documents:
Clinical trial NCT01377233
Conditions: Schizophrenia
Keywords: Schizophrenia Antipsychotic Zicronapine Lu 31-310
Sponsor: H. Lundbeck A/S
Start date: 2011-07-01; Completion date: 2012-02-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.

Detailed description:
The study includes 2 treatment periods. The open-label run-in period will begin at patient enrolment and continue for 3 weeks, during which all patients will receive once daily treatment with zicronapine. The double-blind period will begin at patient randomization and continue for 5 weeks, during which the patients will be assigned to one group receiving once daily treatment with zicronapine and 3 groups receiving once weekly treatment with zicronapine.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Zicronapine open-label lead-in 10 mg daily intervention 2: Zicronapine 10 mg daily intervention 3: Zicronapine 20 mg once weekly intervention 4: Zicronapine 30 mg once weekly intervention 5: Zicronapine 45 mg once weekly
Intervention descriptions: intervention 1: Encapsulated tablet ,10 mg, once daily, open-label intervention 2: Encapsulated tablet, 10 mg, once daily, double-blind intervention 3: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind intervention 4: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind intervention 5: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind

Protocol documents:
Clinical trial NCT00003457
Conditions: Refractory Brain Tumors
Keywords: Anaplastic astrocytoma Anaplastic astrocytoma/Mixed Astrocytoma Astrocytoma/Pilocytic Brainstem glioma Glioblastoma multiforme Glioma Neurocytoma Primitive neuroectodermal tumor Tectal glioma
Sponsor: Burzynski Research Institute
Start date: 1996-07-01; Completion date: 2012-02-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Current therapies for adults with persistent or recurrent brain tumors provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with persistent or recurrent brain tumors.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with persistent or recurrent brain tumors.

Detailed description:
OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in adults with persistent or recurrent brain tumors as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in adults with persistent or recurrent brain tumors.

OVERVIEW: This is a single arm, open-label study in which adults with persistent or recurrent brain tumors receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.

To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study

Arms: arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Interventions: intervention 1: Antineoplaston therapy (Atengenal + Astugenal)
Intervention descriptions: intervention 1: Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Protocol documents:
Clinical trial NCT00177307
Conditions: Cancer
Keywords: colon rectum
Sponsor: University of Pittsburgh
Start date: 2005-01-01; Completion date: 2012-02-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II study of the drug combination of Oxaliplatin, Avastin and capecitabine. This is an open-label study.

Detailed description:
Ongoing clinical trials are now evaluating the addition of bevacizumab to standard chemotherapeutic regimens for colorectal cancer such as FOLFOX or FOLFIRI. In these studies the addition of bevacizumab has been safe and has not resulted in significantly increased toxicity. Our proposed regimen has the advantage of being easily administered in the outpatient setting, with potential for enhanced activity and needs to be evaluated in a clinical trial.

The patterns of care for CRC have shifted, IFL previously the standard of care, is now proven to be an inferior regimen compared to FOLFOX4. (8) The recent FDA approval in February 2004 of bevacizumab for first line therapy, which states that bevacizumab is an approved agent in combination with a 5-FU regimen, gives no clear guidelines as to the "best regimen". This is an issue that needs to be evaluated rapidly in clinical trials, and it is clear that a combination of 5-FU or capecitabine with oxaliplatin and bevacizumab is one of the most active and well-tolerated regimens. The optimum sequence, schedule and doses needs to determined in clinical trials.

Arms: arm 1: None
Interventions: intervention 1: Bevacizumab intervention 2: Capecitabine intervention 3: Oxaliplatin
Intervention descriptions: intervention 1: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity intervention 2: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle). intervention 3: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine

Protocol documents:
Clinical trial NCT00256698
Conditions: Breast Cancer
Keywords: Hormone receptor positive breast cancer first relapse
Sponsor: AstraZeneca
Start date: 2004-01-01; Completion date: 2012-02-01
Enrollment: 514 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.

Detailed description:

Arms: arm 1: Anastrozole arm 2: Anastrozole + Fulvestrant
Interventions: intervention 1: Fulvestrant intervention 2: Anastrozole
Intervention descriptions: intervention 1: intramuscular injection 250 mg loading dose (LD) regimen intervention 2: 1 mg oral tablet

Protocol documents:
Clinical trial NCT00305448
Conditions: Advanced Breast Cancer Metastatic Breast Cancer
Keywords: oncology cancer breast cancer
Sponsor: AstraZeneca
Start date: 2006-03-01; Completion date: 2012-02-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor positive advanced breast cancer.

Detailed description:

Arms: arm 1: Fulvestrant 250 mg intramuscular injection arm 2: Fulvestrant 250mg (Plus 250mg Loading Regimen) arm 3: Fulvestrant 500 mg
Interventions: intervention 1: Fulvestrant intervention 2: Fulvestrant
Intervention descriptions: intervention 1: 250 intramuscular injection intervention 2: 500 mg intramuscular injection

Protocol documents: