ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01378377
Conditions: Advanced Solid Tumor
Keywords: MEK inhibitor Temsirolimus Neoplasms Phase I Pimasertib
Sponsor: EMD Serono
Start date: 2011-05-27; Completion date: 2012-02-23
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The research trial is testing the experimental drug pimasertib and the drug Torisel, given together, in the treatment of advanced solid tumors. The primary purpose of the study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of the drug combination.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Pimasertib intervention 2: Pimasertib intervention 3: Temsirolimus intervention 4: Temsirolimus
Intervention descriptions: intervention 1: Pimasertib will be administered in fasted state at a dose of 45 mg once daily orally on Days 1 to 15. Treatment will be continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent. intervention 2: Pimasertib will be administered in fasted state at a dose of 75 mg once daily orally on Days 1 to 15. Treatment will be continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent. intervention 3: Temsirolimus will be administered at a dose of 12.5 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment will be continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent. intervention 4: Temsirolimus will be administered at a dose of 25 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment will be continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.

Protocol documents:
Clinical trial NCT00880763
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-04-20; Completion date: 2012-02-23
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C infection. The primary hypotheses are that 1.) the proportion of patients achieving rapid viral response (RVR) in one or more of the vaniprevir treatment groups is superior to that in the placebo group, when each is administered concomitantly with pegylated interferon (peg-IFN) α-2a and ribavirin; and 2.) vaniprevir at the studied doses is well tolerated compared with placebo, when each is administered concomitantly with peg-IFN α-2a and ribavirin for 28 days.

Detailed description:

Arms: arm 1: Participants will receive vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. arm 2: Participants will receive vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. arm 3: Participants will receive vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72. arm 4: Participants will receive placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants will continue peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
Interventions: intervention 1: Vaniprevir intervention 2: Pegylated Interferon (peg-IFN) intervention 3: Ribavirin intervention 4: Comparator: Placebo
Intervention descriptions: intervention 1: Vaniprevir oral capsule administered twice daily (200, 600 or 1200 mg/day) for 28 days intervention 2: Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks intervention 3: Open-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks intervention 4: Placebo to vaniprevir oral capsule twice daily for 28 days

Protocol documents:
Clinical trial NCT00321620
Conditions: Bone Metastases
Keywords: Bone metastases Hormone-refractory prostate cancer Skeletal Fractures Compressions Bisphosphonates
Sponsor: Amgen
Start date: 2006-04-01; Completion date: 2012-02-24
Enrollment: 1904 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: zoledronic acid intervention 2: denosumab
Intervention descriptions: intervention 1: Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC intervention 2: Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes

Protocol documents:
Clinical trial NCT01400776
Conditions: Postmenopausal Vulvovaginal Atrophy
Keywords: Postmenopausal Women, Vaginal Dryness
Sponsor: Warner Chilcott
Start date: 2011-06-29; Completion date: 2012-02-27
Enrollment: 722 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study if WC3011 is effective and safe in the treatment of postmenopausal vaginal dryness due to vulvovaginal atrophy.

Detailed description:

Arms: arm 1: WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks. arm 2: Vehicle applied daily for 2 weeks, followed by dosing 2 times a week for 10 weeks. arm 3: WC3011 estradiol vaginal cream applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks. arm 4: Vehicle applied daily for 2 weeks, followed by dosing 3 times a week for 10 weeks.
Interventions: intervention 1: WC3011 Estradiol Vaginal Cream intervention 2: Vehicle
Intervention descriptions: intervention 1: WC3011 estradiol vaginal cream administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks intervention 2: Vehicle administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.

Protocol documents:
Clinical trial NCT01391299
Conditions: Facial Rhytides Glabellar Frown Lines
Sponsor: Allergan
Start date: 2011-06-01; Completion date: 2012-02-28
Enrollment: 175 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of forehead lines (facial rhytides) when also administered to frown lines (glabellar rhytides).

Detailed description:

Arms: arm 1: Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1. arm 2: Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1. arm 3: Placebo (Normal saline) injected into bilateral forehead and frown line areas on Day 1.
Interventions: intervention 1: botulinum toxin Type A intervention 2: Normal Saline
Intervention descriptions: intervention 1: Botulinum toxin Type A (total dose 30 Units or 40 Units) injected into bilateral forehead and frown line areas on Day 1. intervention 2: Normal Saline (placebo) injected into bilateral forehead and frown line areas on Day 1.

Protocol documents:
Clinical trial NCT01059539
Conditions: Bipolar I Disorder
Keywords: Mania Acute mania Bipolar I disorder
Sponsor: Forest Laboratories
Start date: 2010-02-28; Completion date: 2012-02-29
Enrollment: 403 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.

Detailed description:

Arms: arm 1: Participants received cariprazine 1.5 mg orally on Day 1 and cariprazine 3.0 mg orally on Days 2 and 3. Starting on Day 4, the dose could be increased in increments of 3 mg every 2 days up to a maximum dose of 12 mg, if the response was not adequate and there were no tolerability issues based on the judgment of the principal investigator.
Interventions: intervention 1: Cariprazine
Intervention descriptions: intervention 1: Cariprazine was supplied in capsules.

Protocol documents:
Clinical trial NCT00381810
Conditions: Lupus Erythematosus, Systemic
Keywords: Rituxan SLE Lupus
Sponsor: Genentech, Inc.
Start date: 2006-06-22; Completion date: 2012-02-29
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of response at 12 months. This study is open to participants previously enrolled in Genentech Study U2971g only.

Detailed description:

Arms: arm 1: Participants will receive rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants will also receive methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
Interventions: intervention 1: Rituximab intervention 2: Methylprednisolone intervention 3: Acetaminophen intervention 4: Diphenhydramine
Intervention descriptions: intervention 1: Rituximab will be supplied as a liquid for intravenous infusion. intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01001299
Conditions: Malignant Melanoma
Sponsor: Hoffmann-La Roche
Start date: 2009-11-30; Completion date: 2012-02-29
Enrollment: 25 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
This open-label single-arm study will evaluate the effect of RO5185426 \[RG7204; PLEXXIKON: PLX4032\] on the pharmacokinetics of five CYP450 substrates (caffeine, warfarin + vitamin K, omeprazole, dextromethorphan, midazolam) administered as a drug cocktail to patients with metastatic melanoma. The study will also evaluate efficacy and safety of RO5185426. On day 1, patients will receive the drug cocktail. On days 6 to 19, patients will receive RO5185426 twice daily. On day 20, patients will receive RO5185426 and the drug cocktail and on days 21 to 25, patients will receive RO5185426. Assessments will be made at regular intervals during the dosing periods and at follow-up. Patients may continue on study treatment (RO5185426) until the development of progressive disease or unacceptable toxicity. Target sample size \<50.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Drug cocktail intervention 2: RO5185426
Intervention descriptions: intervention 1: Drug cocktail (caffeine, warfarin + vitamin K, omeprazole, dextromethorphan, midazolam) orally once daily, day 1 and day 20 intervention 2: 960 mg orally twice daily

Protocol documents:
Clinical trial NCT01126190
Conditions: Chemotherapy-induced Neutropenia
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2010-06-30; Completion date: 2012-02-29
Enrollment: 381 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.

Detailed description:

Arms: arm 1: Participants will receive pegfilgrastim 6 milligrams (mg), administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/square meter (m\^2) and docetaxel 75 mg/m\^2 administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles. arm 2: Participants will receive neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles. arm 3: Participants will receive neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.
Interventions: intervention 1: Neugranin intervention 2: Pegfilgrastim intervention 3: Chemotherapy
Intervention descriptions: intervention 1: Neugranin will be administered per dose and schedule specified in the arm description. intervention 2: Pegfilgrastim will be administered per dose and schedule specified in the arm description. intervention 3: The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 in combination

Protocol documents:
Clinical trial NCT01296412
Conditions: Diabetes Mellitus, Type 2
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-03-11; Completion date: 2012-02-29
Enrollment: 653 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to compare the effectiveness and safety of two treatment paradigms (oral sitagliptin with or without glimepiride versus liraglutide with or without increased dosing) for the treatment of participants with Type 2 Diabetes that is not adequately controlled with metformin alone. The primary hypothesis postulated that the mean change from baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment is non-inferior to that of participants treated with a liraglutide-based

treatment.

Detailed description:

Arms: arm 1: Sitagliptin 100 mg tablet orally once daily for 26 weeks. Participants continued their stable dose of metformin \>=1500 mg orally daily. Participants may have received glimepiride orally for glycemic control. arm 2: Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin \>=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
Interventions: intervention 1: sitagliptin intervention 2: liraglutide intervention 3: glimepiride intervention 4: metformin
Intervention descriptions: intervention 1: 100 mg tablet, orally, once daily. intervention 2: 0.6 mg by subcutaneous (pen) injection, once daily, on Days 1-7; up-titrated on Day 8 to 1.2 mg daily. At Week 12, dose may be increased to 1.8 mg once daily for participants who did not meet protocol-specified glycemic goals. intervention 3: starting dose of 1 mg tablet (up-titrated as needed), once daily, as needed, after Week 12. intervention 4: metformin tablets at a dose of ≥1500 mg per day

Protocol documents:
Clinical trial NCT00333840
Conditions: Chronic Myelogenous Leukemia
Keywords: CML STI571 imatinib interferon interferon alpha cytosine arabinoside chronic myeloid leukemia Philadelphia chromosome positive
Sponsor: Novartis Pharmaceuticals
Start date: 2000-06-01; Completion date: 2012-03-01
Enrollment: 1106 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to receive either interferon plus Ara-C or imatinib as initial treatment.

Detailed description:

Arms: arm 1: In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10\^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m\^2/day (max 40 mg) SC injection for 10 days every month. Maximum study duration was 11.5 years. arm 2: In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m\^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10\^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
Interventions: intervention 1: imatinib mesilate intervention 2: interferon-alpha (INF-a) intervention 3: cytarabine (ARA-C)
Intervention descriptions: intervention 1: imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules. intervention 2: interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day. intervention 3: cytarabine 20 mg/m\^2/day (max 40 mg) SC for 10 days every month.

Protocol documents:
Clinical trial NCT01072929
Conditions: Depression
Keywords: Bipolar I Disorder
Sponsor: Cephalon
Start date: 2010-01-01; Completion date: 2012-03-01
Enrollment: 433 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.

Detailed description:

Arms: arm 1: Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. arm 2: Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment. arm 3: Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
Interventions: intervention 1: Armodafinil intervention 2: Placebo
Intervention descriptions: intervention 1: Doses of either 150mg/day or 200 mg/day in tablet form taken orally, once daily in the morning. intervention 2: Matching Placebo, also in tablet form taken orally, once daily in the morning.

Protocol documents:
Clinical trial NCT01181479
Conditions: Contraception
Keywords: Contraceptive
Sponsor: Agile Therapeutics
Start date: 2010-08-01; Completion date: 2012-03-01
Enrollment: 1504 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.

Detailed description:
Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).

Arms: arm 1: AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug. arm 2: Lessina containing ethinyl estradiol and levonorgestrel for 6 cycles followed by AG200-15 for 6 cycles. Type of intervention is drug.
Interventions: intervention 1: AG200-15 (cycles 1-13) intervention 2: Lessina crossover to AG200-15
Intervention descriptions: intervention 1: AG200-15 containing ethinyl estradiol and levonorgestrel intervention 2: Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen for 6 cycles followed by AG200-15 for 6 cycles.

Protocol documents:
Clinical trial NCT00075270
Conditions: Neoplasms, Breast
Keywords: metastatic breast cancer ErbB1 kinase inhibitor ErbB2 EGFR lapatinib Her2-neu
Sponsor: GlaxoSmithKline
Start date: 2004-01-01; Completion date: 2012-03-01
Enrollment: 580 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.

Detailed description:

Arms: arm 1: Lapatinib 1500 mg, once daily and Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks arm 2: Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks and Placebo
Interventions: intervention 1: Paclitaxel intervention 2: GW572016 (Lapatinib)
Intervention descriptions: intervention 1: Active Comparator intervention 2: Oral GW572016 Lapatinib

Protocol documents: