ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00488514
Conditions: Migraine Disorders
Keywords: Long-term Safety Migraine Adolescent Migraine Headache sumatriptan succinate naproxen sodium
Sponsor: GlaxoSmithKline
Start date: 2007-07-13; Completion date: 2009-08-20
Enrollment: 656 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents for the acute treatment of migraine.

Detailed description:
This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents (aged 12 to 17 years) for the acute treatment of migraine.

Arms: arm 1: Combination Tablet of Treximet (sumatriptan/naproxen sodium)
Interventions: intervention 1: Combination Tablet of Treximet (sumatriptan/naproxen sodium)
Intervention descriptions: intervention 1: Combination Tablet of Treximet(sumatriptan/naproxen sodium)

Protocol documents:
Clinical trial NCT00127127
Conditions: Tumors
Keywords: Solid tumors
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-06-10; Completion date: 2009-08-21
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral suberoylanilide hydroxamic acid in participants with solid tumors.

Detailed description:

Arms: arm 1: During Cycle 1, participants receive a single oral dose of vorinostat 100 mg on Day 1 in a fasted state, Day 3 in a fed state, and Day 19 in a fed state. On Days 5-18, participants receive vorinostat 100 mg twice daily, in the morning and evening. If participants do not match to the discontinuation criteria, they can continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle will be 26 days.) arm 2: During Cycle 1, participants receive a single oral dose of vorinostat 200 mg on Day 1 in a fasted state; on Day 3 in a fed state; and on Day 19 in a fed state. On Days 5-18, participants receive vorinostat 200 mg twice daily, in the morning and evening. If participants do not match to the discontinuation criteria, they can continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle will be 26 days.) arm 3: During Cycle 1, participants receive a single oral dose of vorinostat 400 mg on Day 1 in a fasted state; on Day 3 in a fed state; and on Day 19 in a fed state. On Days 5-18, participants receive a single oral dose of vorinostat 400 mg once-daily in the morning. If participants do not match to the discontinuation criteria, they can continue the same dose level therapy during Cycle 2 and subsequent cycles. (Each cycle will be 26 days.) arm 4: During Cycle 1, participants receive a single oral dose of vorinostat 500 mg on Day 1 in a fasted state; on Day 3 in a fed state; and on Day 19 in a fed state. On Days 5-18, participants receive a single oral dose of vorinostat 500 mg once-daily in the morning. If participants do not match to the discontinuation criteria, they can continue the same dose level therapy on the Cycle 2 and subsequent cycles.(Each cycle will be 26 days.)
Interventions: intervention 1: vorinostat
Intervention descriptions: intervention 1: vorinostat 100 mg, 200 mg, 400 mg, or 500 mg single oral dose; once-daily or twice-daily administration

Protocol documents:
Clinical trial NCT00742508
Conditions: Heart Failure, Congestive
Keywords: carvedilol phosphate ß-blocker SK&F-105517-D Chronic heart failure(CHF)
Sponsor: GlaxoSmithKline
Start date: 2008-08-28; Completion date: 2009-08-21
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the safety and tolerability of SK\&F-105517-D in japanese patients with chronic heart failure.

Detailed description:

Arms: arm 1: SK\&F-105517-D 10-80 mg/day arm 2: Carvedilol-IR 5-20 mg/day
Interventions: intervention 1: SK&F-105517-D 10 mg capsule intervention 2: Carvedilol-immediate release (IR) 2.5 mg tablet intervention 3: SK&F-105517-D 20 mg capsule intervention 4: SK&F-105517-D 40 mg capsule intervention 5: Carvedilol-IR 10 mg tablet
Intervention descriptions: intervention 1: 1 capsule once a day intervention 2: 1 or 2 tablet(s) twice a day intervention 3: 1 capsule once a day intervention 4: 1 or 2 capsule(s) once a day intervention 5: 1 tablet twice a day

Protocol documents:
Clinical trial NCT00758836
Conditions: Migraine
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-12-03; Completion date: 2009-08-24
Enrollment: 683 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the safety and how effective telcagepant is when taken with ibuprofen or acetaminophen in participants with migraine with or without aura. The primary study hypothesis is that at least one drug combination is superior to telecagepant alone in the treatment of acute migraines.

Detailed description:

Arms: arm 1: Participants take two placebo tablets and two placebo capsules, orally, at onset of migraine arm 2: Participants take one telcagepant 280 mg tablet, one ibuprofen 400 mg tablet, and two placebo capsules, orally, at onset of migraine arm 3: Participants take one telcagepant 280 mg tablet, one placebo tablet, and two 500-mg APAP capsules, orally, at onset of migraine arm 4: Participants take one telcagepant 280 mg tablet, one placebo tablet, and two placebo capsules, orally, at onset of migraine
Interventions: intervention 1: placebo intervention 2: ibuprofen intervention 3: acetominophen intervention 4: telcagepant
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00619866
Conditions: Endometriosis, Pain
Keywords: bone mineral density Pelvic Pain estradiol NBI-56418
Sponsor: AbbVie
Start date: 2008-02-19; Completion date: 2009-08-28
Enrollment: 155 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to see how elagolix works compared to placebo in women with endometriosis and to see the effect, if any, on bone mineral density.

Detailed description:
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled parallel-group study to assess the efficacy and safety of elagolix at two dose levels administered once daily for up to 6 months. Participants will be randomized (1:1:1) to one of the following treatment groups for the first 12 weeks of dosing: 150 mg elagolix once daily (QD); 250 mg elagolix QD or placebo QD. Following 12 weeks of dosing, participants will continue in the study for an additional 12 weeks; participants randomized to elagolix will continue to receive their assigned dose and participants randomized to placebo will be re-randomized to receive one of the two doses of elagolix for 12 weeks in a double-blind fashion. Six weeks after the last dose of study drug at the end of Week 24, a follow-up visit will be performed (end of Week 30).

Arms: arm 1: Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks. arm 2: Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks. arm 3: Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.
Interventions: intervention 1: Elagolix intervention 2: placebo
Intervention descriptions: intervention 1: Elagolix tablets administered orally intervention 2: Placebo tablet administered orally

Protocol documents:
Clinical trial NCT00294515
Conditions: Cytomegalovirus Infections
Sponsor: Hoffmann-La Roche
Start date: 2006-03-31; Completion date: 2009-08-31
Enrollment: 326 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the relative efficacy and safety of up to 100 days Valcyte prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Valganciclovir for up to 100 days post kidney transplant arm 2: Valganciclovir for up to 200 days post kidney transplant
Interventions: intervention 1: Valganciclovir intervention 2: Valganciclovir
Intervention descriptions: intervention 1: 900 mg orally daily for up to 100 days intervention 2: 900 mg orally daily for up to 200 days

Protocol documents:
Clinical trial NCT00694707
Conditions: Schizophrenia
Sponsor: Forest Laboratories
Start date: 2008-06-30; Completion date: 2009-08-31
Enrollment: 732 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.

Detailed description:

Arms: arm 1: Participants received placebo orally once a day for 6 weeks. arm 2: Participants received cariprazine 1.5 mg orally once a day for 6 weeks. arm 3: Participants received cariprazine 3.0 mg orally once a day for 6 weeks. arm 4: Participants received cariprazine 4.5 mg orally once a day for 6 weeks. arm 5: Participants received risperidone 4.0 mg orally once a day for 6 weeks.
Interventions: intervention 1: Placebo intervention 2: Cariprazine intervention 3: Risperidone
Intervention descriptions: intervention 1: Placebo was supplied in capsules. intervention 2: Cariprazine was supplied in capsules intervention 3: Risperidone was supplied in capsules

Protocol documents:
Clinical trial NCT00958412
Conditions: Endometriosis
Keywords: Endometriosis Pelvic pain Oral progesterone blocker
Sponsor: Repros Therapeutics Inc.
Start date: 2009-02-28; Completion date: 2009-08-31
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
ZPE-201 Extension of treatment

Detailed description:
This is an extension of the phase II, three-arm, parallel design, dose-ranging, placebo-controlled, randomized, double-blind, multicenter study in which placebo or one (1) of two (2) dose levels of Proellex® was administered once-daily for four (4) months.

Arms: arm 1: 25 mg Proellex®
Interventions: intervention 1: Proellex®
Intervention descriptions: intervention 1: one (1) 25 mg capsule daily

Protocol documents:
Clinical trial NCT00095576
Conditions: AIDS HIV Infections
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-11-01; Completion date: 2009-09-01
Enrollment: 3000 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the safety and efficacy of an investigational Human Immunodeficiency Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected.

On September 18, 2007 the Protocol V520-023 DSMB (Data \& Safety Monitoring Board) reviewed data from a planned interim analysis. These data demonstrated that the investigational vaccine candidate was not effective, and all vaccinations in the study were halted.

Participants were encouraged to continue to come to the clinic for scheduled visits and ongoing risk reduction counseling since the vaccine was not effective.

Detailed description:
No further treatment was given in V520-023, however participants were followed. V520-023 protocol ended earlier than originally planned per protocol and participants (HIV infected and uninfected) had the option of participating in an observational long term follow up protocol called V520-030/HVTN 504, which served as an extension of V520-023 and would continue through the end of 2009.

Arms: arm 1: Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10\^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26. arm 2: Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
Interventions: intervention 1: Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10^10 ad-vg/dose) intervention 2: Comparator: placebo
Intervention descriptions: intervention 1: Trivalent MRKAd5 HIV-1 gag/pol/nef (1.5x10\^10 adenovirus genomes \[ad-vg\]/dose).

This dose is equivalent to 3x10\^10 vp/dose used in study V520-016. intervention 2: Placebo to Trivalent MRKAd5 HIV-1 gag/pol/nef in three 1 mL doses at Day 1, Week 4, and Week 26 administered intramuscularly.

Protocol documents:
Clinical trial NCT00132314
Conditions: Schizoaffective Disorder Schizophrenia
Sponsor: US Department of Veterans Affairs
Start date: 2006-09-01; Completion date: 2009-09-01
Enrollment: 382 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In the proposed study 450 veterans with a primary diagnosis of schizophrenia who had at least one psychiatric hospitalization for schizophrenia in the previous 2 years would be randomly assigned at 16 VA medical centers to long-acting injectable risperidone or doctor's choice of oral antipsychotic medication (i.e., excluding other long-acting injectable medications, but not specifying any particular oral agents or dosages). Recruitment would take 27 months to complete, and the study would continue for a third year to allow 9 months of follow-up for the last patient recruited. All patients would be treated from the time of entry up to the end of the three-year study period. Follow-up assessments would continue quarterly. Treatments would not be blinded since giving placebo injections to the comparison group would interfere with the goal of comparing the acceptability of two different methods of medication administration. However, end points will be blindly rated.

Detailed description:
The purpose of the study is to assess the effectiveness of long-acting injectable risperidone on psychiatric inpatient hospitalization, schizophrenia symptoms, quality of life, medication adherence, side effects, and health care costs.

Objectives:

Primary: To evaluate the impact of long-acting intramuscular (IM) risperidone on risk of inpatient psychiatric hospitalization in comparison to standard oral antipsychotic treatment in a randomized controlled trial to be conducted with 450 veterans diagnosed with schizophrenia or schizoaffective disorder at 16 VA medical centers over three years.

Secondary: To evaluate adherence, health benefits, and costs of long-acting IM risperidone as compared to standard oral antipsychotic treatment as measured by: a) symptom reduction over 12 months, b) time to all-cause medication discontinuation, c) quality of life, d) VA and non-VA health service use and related costs, e) medication side effects, f) violent behavior, g) use of concomitant medication, and h) the incremental cost-effectiveness ratio.

Arms: arm 1: long-acting injectable risperidone arm 2: oral antipsychotic medication
Interventions: intervention 1: IM risperidone intervention 2: oral antipsychotic medication
Intervention descriptions: intervention 1: long-acting injectable risperidone intervention 2: doctor's choice (excluding other long-acting injectable medications but not specifying any particular oral agents or dosages)

Protocol documents:
Clinical trial NCT00162266
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2000-10-01; Completion date: 2009-09-01
Enrollment: 524 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was conducted to assess the safety and tolerability of Abatacept combined with Methotrexate in participants with active rheumatoid arthritis (RA). The secondary objectives were to assess efficacy, pharmacodynamic marker activity, and immunogenicity of Abatacept combined with Methotrexate.

Detailed description:
All participants who completed the 12-month double-blind study period were eligible to continue in the open-label study. Participants received placebo, Abatacept 2 mg/kg, or Abatacept 10 mg/kg in the double-blind study. Participants receiving placebo in the double-blind study were switched 1:1 to continued treatment with placebo or Abatacept 2 mg/kg. Participants receiving Abatacept 2 mg/kg or Abatacept 10 mg/kg continued at the double-blind study dosage. After results from the double-blind period became available, all participants were switched to a weight-tiered 10 mg/kg dose of Abatacept.

Open label study design: Single group assignment, Single arm, Open label,

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Abatacept (BMS-188667) intervention 2: Abatacept (BMS-188667) intervention 3: Abatacept (BMS-188667) intervention 4: Placebo
Intervention descriptions: intervention 1: IV, 10 mg/Kg, monthly, for the duration of the trial intervention 2: Intravenous (IV) infusion, 2 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months intervention 3: Intravenous (IV) infusion, 10 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months intervention 4: Intravenous (IV) infusion, 0 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months

Protocol documents:
Clinical trial NCT00320489
Conditions: Schizophrenia
Sponsor: Eli Lilly and Company
Start date: 2006-04-01; Completion date: 2009-09-01
Enrollment: 524 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the health outcome of patients with schizophrenia, who are at risk for relapse, when treated with a long acting injection form of olanzapine versus treatment with oral olanzapine.

Detailed description:

Arms: arm 1: Olanzapine pamoate depot arm 2: Oral olanzapine
Interventions: intervention 1: olanzapine intervention 2: olanzapine pamoate depot
Intervention descriptions: intervention 1: 10 milligrams (mg), oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks. intervention 2: 405 milligrams (mg), intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.

Protocol documents:
Clinical trial NCT00335452
Conditions: Acute Coronary Disease Angina Unstable
Keywords: platelet aggregation inhibitors acute coronary disease percutaneous coronary
Sponsor: Sanofi
Start date: 2006-06-01; Completion date: 2009-09-01
Enrollment: 25086 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death (CV death), myocardial infarction (MI), stroke) after a percutaneous coronary intervention (PCI).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Clopidogrel intervention 2: acetylsalicyclic acid (ASA)
Intervention descriptions: intervention 1: oral administration intervention 2: oral administration

Protocol documents:
Clinical trial NCT00417079
Conditions: Neoplasms Prostatic Neoplasms
Keywords: Cancer Prostate
Sponsor: Sanofi
Start date: 2007-01-01; Completion date: 2009-09-01
Enrollment: 755 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.

Detailed description:

Arms: arm 1: Mitoxantrone + Prednisone arm 2: Cabazitaxel + Prednisone
Interventions: intervention 1: cabazitaxel (XRP6258) (RPR116258) intervention 2: mitoxantrone intervention 3: prednisone
Intervention descriptions: intervention 1: 25 mg/m\^2 administered by intravenous (IV) route over 1 hour on day 1 of each 21-day cycle intervention 2: 12 mg/m\^2 administered by intravenous (IV) route over 15-30 minutes on day 1 of each 21-day cycle intervention 3: 10 mg daily administered by oral route

Protocol documents:
Clinical trial NCT00423319
Conditions: Deep Vein Thrombosis Pulmonary Embolism
Keywords: Prevention of deep vein thrombosis and pulmonary embolism after total hip replacement surgery
Sponsor: Bristol-Myers Squibb
Start date: 2007-03-01; Completion date: 2009-09-01
Enrollment: 5407 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban will also be studied

Detailed description:

Arms: arm 1: Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD) arm 2: Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
Interventions: intervention 1: Enoxaparin intervention 2: Apixaban intervention 3: Enoxaparin-matching placebo intervention 4: Apixaban-matching placebo
Intervention descriptions: intervention 1: Subcutaneous, 40 mg, once daily, 5 weeks intervention 2: Oral tablets, 2.5 mg, twice daily, 5weeks intervention 3: Administered as injection intervention 4: Administered as oral tablets

Protocol documents:
Clinical trial NCT00428584
Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)
Sponsor: EMD Serono
Start date: 2006-12-01; Completion date: 2009-09-01
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the tolerability of a new formulation of rebif and Betaseron in subjects with relapsing-remitting multiple sclerosis (RRMS) by comparing the mean change in injection site pain scores from pre-injection to 30 minutes post therapy administration.

Detailed description:

Arms: arm 1: interferon beta-1a arm 2: interferon beta-1b
Interventions: intervention 1: New Formulation of rebif - human interferon beta-1a intervention 2: Interferon beta -1b
Intervention descriptions: intervention 1: New Formulation of rebif- 44 mcg, SC (sub-cutaneous) thrice weekly (tiw) injection. intervention 2: Betaseron - 250 mcg, SC (sub-cutaneous) every other day injection.

Protocol documents: