ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00808210
Conditions: Rheumatoid Arthritis
Keywords: RA Arthritis
Sponsor: Genentech, Inc.
Start date: 2009-03-05; Completion date: 2012-11-14
Enrollment: 28 participants; Allocation: NA; Intervention model: PARALLEL

Brief summary:
This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.

Detailed description:

Arms: arm 1: Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. arm 2: Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
Interventions: intervention 1: Infliximab intervention 2: Methotrexate intervention 3: Methylprednisolone intervention 4: Ocrelizumab intervention 5: Placebo
Intervention descriptions: intervention 1: Intravenous repeating dose intervention 2: Oral or parenteral repeating dose intervention 3: Intravenous repeating dose intervention 4: Intravenous repeating dose intervention 5: Intravenous repeating dose

Protocol documents:
Clinical trial NCT01064817
Conditions: Glaucoma
Keywords: glaucoma, trabeculectomy
Sponsor: Hoffmann-La Roche
Start date: 2010-06-14; Completion date: 2012-11-14
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and tolerability of PRM-151 administered as a subconjunctival injection and explore the effect of PRM-151 on various correlates of the wound healing process that occurs in the eye after glaucoma filtration surgery.

Detailed description:
Glaucoma is a disease of the eye which affects the optic nerve (the nerve that sends signals from the eye to the brain) and is associated with visual field defects and potential blindness. The treatment of glaucoma involves lowering the pressure in the eye, which is often (but not always) elevated due to accumulation of fluid inside the eye that cannot drain away. In the operation called trabeculectomy (a type of filtration surgery), a small channel is created through the sclera (the white of the eye) to allow accumulated fluid to drain away. Scarring may occur after surgery when, during healing, too much collagen (a type of protein) is deposited in the channel. This causes the channel to seal up and the pressure inside the eye to build up again.

The study will be conducted in patients suffering from glaucoma who are due to undergo trabeculectomy. Patients will be randomized to have either PRM-151 or placebo.

Arms: arm 1: PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2) arm 2: Placebo
Interventions: intervention 1: PRM-151 intervention 2: Placebo
Intervention descriptions: intervention 1: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9 intervention 2: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9

Protocol documents:
Clinical trial NCT01206816
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2010-10-04; Completion date: 2012-11-15
Enrollment: 57 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
The primary objective of the current study is to investigate the Maximum Tolerated Dose (MTD) in terms of safety and tolerability of the combination of BI 6727 with BIBW 2992, in patients with advanced or metastatic solid tumours. Dosages of both BI 6727 and BIBW 2992 will be varied to establish the MTD of the combination. Two combination treatment schedules will be tested, the MTD of each combination will be determined.

Secondary objectives are the exploration of pharmacokinetics, overall safety and preliminary efficacy.

Detailed description:

Arms: arm 1: patients receive increasing doses of BI 6727 in combination with increasing doses of BIBW 2992
Interventions: intervention 1: BI 6727 + BIBW 2992
Intervention descriptions: intervention 1: BI 6727 administered i.v. every 21 days + BIBW 2992 given orally once a day

Protocol documents:
Clinical trial NCT01513590
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2012-01-16; Completion date: 2012-11-19
Enrollment: 394 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia and Europe. The aim of the trial is to compare the efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 (biphasic insulin aspart 30) in insulin naïve subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/insulin aspart
Intervention descriptions: intervention 1: Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued.

Protocol documents:
Clinical trial NCT01075984
Conditions: Fungal Infection
Keywords: Antifungal Agents pharmacokinetics Mycoses prevention and control
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-02-23; Completion date: 2012-11-20
Enrollment: 279 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to collect pharmacokinetic (PK) information related to how well intravenous Posaconazole (POS IV), is distributed in the body and to determine the safety and tolerability of this new formulation. In addition, the PK, safety, and tolerability of switching from taking POS IV to taking Posaconazole Oral Suspension (POS Oral) will be evaluated. The data collected in this study will be compared to data collected in previous studies.

Individuals who have been diagnosed by their physicians with a blood disease or cancer that can affect their infection-fighting white blood cells will be asked to participate in the trial. Since these blood diseases and their treatments can weaken the immune system, they may put these individuals at a high risk for getting a serious fungal infection of their internal organs or blood (invasive fungal infection). As these fungal infections can be hard to detect early and can be life-threatening, many physicians believe that individuals diagnosed with these diseases should receive antifungal therapy to try to lower their risk of getting this type of infection.

Enrollment into this study will take place in several stages (cohorts). The determination of which cohort an individual will be asked to participate in is based on which cohort is open at the site at the time the individual is approached to consider study participation.

Detailed description:

Arms: arm 1: POS 200 mg IV single dose infused over 1.5 hours on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0) arm 2: Placebo IV single dose infused over 1.5 hours on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0) arm 3: POS 200 mg IV infused over 1.5 hours BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1) arm 4: POS 300 mg IV infused over 1.5 hours BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability. arm 5: POS 300 mg IV infused over 1.5 hours BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28, or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
Interventions: intervention 1: Posaconazole intervention 2: Dextrose 5% in water
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01588509
Conditions: Osteoporosis
Keywords: AMG 785, bone mineral density, alendronate
Sponsor: Amgen
Start date: 2012-03-30; Completion date: 2012-11-21
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated with alendronate.

Detailed description:

Arms: arm 1: Participants received romosozumab 140 mg administered subcutaneously once a month for 3 months. arm 2: Participants received romosozumab 210 mg administered subcutaneously once a month for 3 months.
Interventions: intervention 1: Romosozumab
Intervention descriptions: intervention 1: Administered by subcutaneous injection

Protocol documents:
Clinical trial NCT01336023
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2011-05-23; Completion date: 2012-11-22
Enrollment: 1663 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted globally. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide (Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment with metformin or metformin + pioglitazone throughout the entire trial.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: insulin degludec/liraglutide intervention 2: insulin degludec intervention 3: liraglutide
Intervention descriptions: intervention 1: Insulin degludec/liraglutide treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). Insulin degludec/liraglutide is injected subcutaneously (under the skin) once daily. intervention 2: Insulin degludec treatment will be initiated with 10 U and titrated (individually adjusted) twice weekly according to the mean SMPG (fasting). Insulin degludec is injected subcutaneously (under the skin) once daily. intervention 3: Liraglutide will be started with 0.6 mg and subsequent 0.6 mg weekly dose escalation to 1.8 mg. Liraglutide dose of 1.8 mg/day will be continued for the remaining part of the trial. Liraglutide is injected subcutaneously (under the skin) once daily.

Protocol documents:
Clinical trial NCT00676663
Conditions: Breast Cancer Estrogen Receptor-Positive Breast Cancer Breast Cancer, Estrogen Receptor-Positive ER+ Breast Cancer
Keywords: Breast Neoplasms Breast Tumor Mammary Neoplasms
Sponsor: Syndax Pharmaceuticals
Start date: 2008-06-13; Completion date: 2012-11-26
Enrollment: 130 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 exemestane in the treatment of advanced breast cancer.

Detailed description:

Arms: arm 1: Exemestane (Aromasin®) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first. arm 2: Exemestane (Aromasin®) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.
Interventions: intervention 1: entinostat intervention 2: exemestane intervention 3: Placebo
Intervention descriptions: intervention 1: Entinostat 5 mg tablet orally once per week intervention 2: Exemestane 25 mg tablet orally once daily intervention 3: Placebo-matching entinostat tablet orally once per week

Protocol documents:
Clinical trial NCT01032070
Conditions: Recurrent or Refractory Pediatric Ependymoma
Keywords: pediatric etoposide erlotinib phase 2 ependymoma
Sponsor: OSI Pharmaceuticals
Start date: 2010-09-27; Completion date: 2012-11-26
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 2 study to evaluate the efficacy of single-agent erlotinib versus oral etoposide in patients with recurrent or refractory pediatric ependymoma.

Detailed description:
This is a phase 2 study involving a 1:1 randomization of 40 patients with recurrent or refractory pediatric ependymoma who will receive either erlotinib or oral etoposide.

Arms: arm 1: Erlotinib was administered orally at a dose of 85 mg/m\^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity. arm 2: Etoposide 50 mg/m\^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Interventions: intervention 1: erlotinib intervention 2: etoposide
Intervention descriptions: intervention 1: oral intervention 2: oral

Protocol documents:
Clinical trial NCT01640249
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2012-07-24; Completion date: 2012-11-26
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of the study drug. The study drug will be given in the morning or evening with or without a meal.

This is the first time that this study drug is being given to humans. This study is for research purposes only and is not intended to treat any medical condition.

Detailed description:
This study has two parts:

Part A - single ascending dose of LY3006072 administered to healthy participants in 3 of 4 study periods (placebo in 1 of 4 periods).

Part B - morning and evening doses of LY3006072 given to healthy participants in fed and fasted states in 2 or 3 of 3 study periods (placebo in 1 of 3 periods for some participants).

Arms: arm 1: Participants received placebo capsule orally with approximately 200 to 300 milliliter (mL) of room temperature water in the morning. arm 2: Participants received LY3006072 capsules starting at 1 milligram (mg) and escalating doses of 3 mg, 10 mg, 20 mg and 40 mg.
Interventions: intervention 1: Placebo intervention 2: LY3006072
Intervention descriptions: intervention 1: Capsules administered orally intervention 2: Capsules administered orally

Protocol documents:
Clinical trial NCT00821964
Conditions: Male Breast Cancer Recurrent Breast Cancer Skin Metastases Stage IV Breast Cancer
Keywords: Breast Cancer Stage IV cream topical
Sponsor: University of Washington
Start date: 2008-12-01; Completion date: 2012-11-29
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying the side effects of giving topical imiquimod together with Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) to see how well it works in treating patients with advanced breast cancer. Biological therapies, such as imiquimod, may stimulate the immune system to kill tumor cells. Drugs used in chemotherapy, such as Abraxane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imiquimod together with Abraxane may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the safety of chemoimmunotherapy with topical imiquimod and Abraxane in breast cancer patients with recurrent chest wall disease or cutaneous metastasis.

II. To evaluate the anti-tumor effects of chemoimmunotherapy with topical imiquimod and Abraxane in breast cancer patients with recurrent chest wall disease or cutaneous metastasis.

SECONDARY OBJECTIVES:

I. To examine whether treatment with chemoimmunotherapy consisting of topical imiquimod and Abraxane augments endogenous tumor specific immunity.

II. To assess the effect of chemoimmunotherapy on circulating transforming growth factor (TGF)-beta levels.

OUTLINE:

Patients receive Abraxane intravenously (IV) over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions once daily (QD) on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 4, 8, and 12 weeks.

Arms: arm 1: Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: imiquimod intervention 2: Abraxane intervention 3: laboratory biomarker analysis intervention 4: RNA analysis intervention 5: immunoenzyme technique
Intervention descriptions: intervention 1: Given topically intervention 2: Given IV intervention 3: Correlative studies intervention 4: Correlative studies intervention 5: Correlative studies

Protocol documents:
Clinical trial NCT01313559
Conditions: Castrate Resistant Prostate Cancer Chemotherapy Naive Prostate Cancer Prostate Cancer
Keywords: Castrate Resistant Chemotherapy Naive Prostate Cancer SOM230 Everolimus
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Start date: 2011-06-01; Completion date: 2012-11-29
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open label randomized phase II study for prostate cancer patients who have disease progression after hormonal therapy. SOM230 LAR (Pasireotide) binds to its receptor of prostate cancer cells and can prevent them from growing. Everolimus works by targeting a cell survival factor in prostate cancer. The combination of these drugs may work better for the treatment of prostate cancer without toxic chemotherapy. Patients will receive either SOM230 LAR (group A) or SOM230 LAR in combination with Everolimus (group B).

Detailed description:
Prostate cancer cells typically have neuroendocrine (NE) differentiation features after they become resistant to hormonal therapy. Somatostatin (SST - a peptide hormone) receptors (SSTR) are usually expressed in a high level in these advanced prostate cancer cells. When SSTR is activated pharmacologically by drugs similar to SST, prostate cancer cell growth is inhibited. SOM230 is a new agent which can activate SSTR and block other key survival molecules/pathways such as phosphatidylinositol 3-kinases (PI3K), mitogen-activated protein (MAP) kinases (MAPK) signaling pathways. Thus SOM230 itself has anticancer activity for prostate cancer.

It is also well known that hormonal refractory prostate cancer can grow in an environment of very low male hormone level because of the activation of several non-androgen receptor survival pathways. One key survival pathway is mediated by an important molecule called mammalian target of rapamycin (mTOR). Drugs, such as Everolimus, have anticancer activity in prostate cancer pre-clinically, but do not sustain its activity. The reason was that cancer cells can up-regulate other survival pathways such as PI3K, MAPK, thus bypass mTOR.

It is hypothesized that SOM230 not only have anti-tumor effect in prostate cancer directly, but also can block the up-regulated (feed-back loop), alternative PI3K or MAPK survival pathways induced by mTOR inhibitors.

The goal of this study is to develop a new well tolerated therapy that can be offered to prostate cancer patients prior to receiving chemotherapy.

Arms: arm 1: Patients receive pasireotide IM once every 4 weeks arm 2: Patients receive pasireotide as in cohort A and everolimus PO QD
Interventions: intervention 1: Pasireotide intervention 2: Everolimus intervention 3: Laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IM intervention 2: Given PO intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01252719
Conditions: Wound Infection Abscess Systemic Inflammation Cellulitis
Keywords: ABSSSI Skin Infection Abscess
Sponsor: Melinta Therapeutics, Inc.
Start date: 2010-12-01; Completion date: 2012-11-30
Enrollment: 968 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this Phase 3 trial was to evaluate the efficacy, safety, and tolerability of oritavancin in acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant staphylococcus aureus (MRSA), and to evaluate the potential economic benefit of oritavancin administered as a single 1200-milligram (mg) intravenous (IV) dose.

Detailed description:
This was a Phase 3, multicenter, randomized, double-blind, parallel, comparative efficacy and safety study of single-dose IV oritavancin/IV placebo versus IV vancomycin for 7 to 10 days in adults with ABSSSI suspected or proven to be caused by gram-positive pathogens. Approximately 960 participants were to be randomized at 100 centers globally.

In addition, this study characterized the pharmacokinetics (PK) and PK/pharmacodynamics (PD) properties of a single 1200-mg IV dose of oritavancin and evaluated the potential health economic benefits offered by this dosing strategy.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Single-Dose IV Oritavancin Diphosphate intervention 2: IV Vancomycin intervention 3: Placebo
Intervention descriptions: intervention 1: Oritavancin was administered as a single IV dose. intervention 2: Intravenous vancomycin was administered for a minimum of 7 days and up to a maximum of 10 days. intervention 3: Intravenous placebo was administered thereafter, for a minimum of 7 days and up to a maximum of 10 days (oritavancin and placebo).

Protocol documents:
Clinical trial NCT01342640
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2011-07-18; Completion date: 2012-11-30
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: Recommended starting dose 1.2 micrograms/kg subcutaneously every 4 weeks (depending on patient's weight). Dose adjustment may be required in the event of inadequate or excessive treatment response.

Protocol documents: