ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01018563
Conditions: Epithelial Ovarian Cancer
Keywords: Extension study Epithelial ovarian cancer
Sponsor: Morphotek
Start date: 2010-01-13; Completion date: 2013-03-05
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
An open label extension of the MORAb-003-002 study in order to continue the active patients in the MORAb-003-002 study on maintenance MORAb-003 infusions after the main study is closed.

Detailed description:

Arms: arm 1: Maintenance infusions of MORAb-003 every 3 weeks
Interventions: intervention 1: MORAb-003
Intervention descriptions: intervention 1: Dose group to be determined by dose assigned in main study and patient's weight. Intravenous infusions are given every 3 weeks.

Protocol documents:
Clinical trial NCT01662102
Conditions: Follicular Lymphoma
Sponsor: Spectrum Pharmaceuticals, Inc
Start date: 2012-12-11; Completion date: 2013-03-05
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of consolidation treatment Zevalin® versus maintenance treatment with Rituxan® on progression-free survival (PFS) following response induction with chemotherapy plus rituximab in previously untreated participants with follicular lymphoma.

Detailed description:
This is an open-label, multicenter and randomized study. Participants registered after response induction (PR/CR) to R-chemotherapy. Participants achieving either a partial response (PR) or complete response (CR) following R-chemotherapy eligible for randomization to either consolidation with 90Y-ibritumumab tiuxetan followed by observation for 24 months, or rituximab maintenance for 24 months. After the observation/maintenance period, patients follow up for 5 years.

This study was terminated early for business reasons. (Maximum duration of study was up to approximately 2.7 months).

Arms: arm 1: 90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10\^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq \[0.4 mCi\] yttrium-90/kg and Body weight \>80 kg: 1,184 MBq \[32 mCi\] maximum dose).

The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m\^2); Day 7,8, or 9 rituximab (250 mg/m\^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months). arm 2: Participants were to receive 375 mg/m\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).
Interventions: intervention 1: Zevalin intervention 2: Rituximab
Intervention descriptions: intervention 1: Zevalin administered intravenously. intervention 2: Rituximab administered intravenously.

Protocol documents:
Clinical trial NCT00121992
Conditions: Breast Neoplasms
Keywords: High risk node negative breast cancer Disease-Free survival Quality of life
Sponsor: Spanish Breast Cancer Research Group
Start date: 1999-07-01; Completion date: 2013-03-06
Enrollment: 1060 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, non-blinded randomized phase III trial. Patients will be post-surgically stratified at inclusion first according to the participating institution, then according to menopausal status and will be randomly assigned to receive either:

* TAC: Docetaxel 75 mg/m2 as a 1 hour intravenous (i.v.) infusion on day 1 every 3 weeks (q3w) in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.
* FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.

Detailed description:
Primary objective:

* To compare disease-free survival (DFS) after treatment with docetaxel in combination with doxorubicin and cyclophosphamide (TAC) to 5-Fluorouracil in combination with doxorubicin and cyclophosphamide (FAC) as adjuvant treatment of high risk operable breast cancer patients with negative axillary lymph nodes.

Secondary objectives:

* To compare overall survival (OS) between the 2 above mentioned arms.
* To compare toxicity and quality of life between the 2 above mentioned arms.
* To evaluate pathologic markers for predicting efficacy (hormonal receptors and human epidermal growth factor receptor 2 (HER2) protein expression).

Arms: arm 1: FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv arm 2: TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv
Interventions: intervention 1: Docetaxel intervention 2: 5-fluorouracil intervention 3: Doxorubicin intervention 4: Cyclophosphamide
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01767688
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-01-16; Completion date: 2013-03-07
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate and compare the pharmacokinetics of a single 25-mg dose of MK-3102 in participants with moderate hepatic impairment and matched healthy participants. The primary hypothesis is that in participants with moderately impaired hepatic function, the area under the concentration-time curve from time zero to infinity (AUC0-∞) is similar to that observed in healthy matched control participants following a single 25 mg oral dose of MK-3102. Specifically, the true ratio (moderately impaired hepatic function patients/healthy matched control subjects) of geometric means for AUC0-∞ is no greater than 2.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MK-3102
Intervention descriptions: intervention 1: Single dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.

Protocol documents:
Clinical trial NCT01716455
Conditions: Impaired Renal Function
Sponsor: Shire
Start date: 2012-10-29; Completion date: 2013-03-10
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Shire is developing SSP-004184 (FBS0701), a novel iron chelator , for the treatment of chronic iron overload in patients with transfusion-dependent hereditary and acquired anemias. The primary purpose of the study is to assess the pharmacokinetics of SSP-004184 (FBS0701) following a single 75mg/kg dose of SSP-004184 (FBS0701) in healthy adults and elderly subjects and in adult subjects with mild, moderate, severe, and end stage renal disease (ESRD) degrees of impaired renal function. The results of this study will characterize the pharmacokinetics, safety, and tolerability of SSP-004184 (FBS0701) in adult subjects with various degrees of renal impairment, and these data will be compared to healthy adult and elderly subjects.

Detailed description:

Arms: arm 1: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 arm 2: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 arm 3: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 arm 4: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 arm 5: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 arm 6: All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1. Healthy subjects matched to renally impaired subjects in arms 1 through 4. (Note: One healthy subject can match more than one renally impaired subject.)
Interventions: intervention 1: SSP-004184
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01499043
Conditions: Prostate Cancer
Keywords: CRPC Prostate Cancer Bone metastasis Advanced Castration-Resistant Prostate Cancer (CRPC)
Sponsor: Daiichi Sankyo
Start date: 2012-05-25; Completion date: 2013-03-11
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main objective of this study is to evaluate the effects of PLX3397 on male subjects with CRPC.

Secondary objectives include evaluating the safety and tolerability of PLX3397 and the anti-tumor effects that PLX3397 has on the the subjects.

Detailed description:

Arms: arm 1: Participants will take daily oral dose of PLX3397 for 28 day cycles. Participants will continue to take PLX3397 until disease progression or toxicity.
Interventions: intervention 1: PLX3397
Intervention descriptions: intervention 1: Capsules administered twice daily, continuous dosing. Subjects will take PLX3397 at 1000 mg/day.

Protocol documents:
Clinical trial NCT00819039
Conditions: Postoperative Nausea and Vomiting
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-01-26; Completion date: 2013-03-12
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This two part study will determine the appropriate dosing regimen of aprepitant for the prevention of postoperative nausea and vomiting (PONV) in pediatric participants 6 months to 17 years of age, by assessing pharmacokinetic parameters and monitoring safety and tolerability of administered doses. Part I will be an open label investigation of a single dose of aprepitant measuring pharmacokinetics at specified time points up to 48 hours after aprepitant dosing. Part II will be a double blind trial of participants randomized to receive either aprepitant or ondansetron.

Detailed description:

Arms: arm 1: In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1. arm 2: In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1. arm 3: In Study Part 2, participants aged 6 months to 17 years received a single intravenous dose of ondansetron on Day 1.
Interventions: intervention 1: Aprepitant intervention 2: Ondansetron
Intervention descriptions: intervention 1: Aprepitant administered orally or intraveously. intervention 2: Ondansetron administered intravenously.

Protocol documents:
Clinical trial NCT01405937
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-08-29; Completion date: 2013-03-12
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (PegIntron®/peg-IFN) and ribavirin (RBV) in chronic hepatitis C (CHC) Genotype I (GT 1) participants who relapsed after previous therapy with interferon-based therapy. The primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (SVR24) in at least one of the vaniprevir 300 mg twice daily treatment regimens is greater than 20% (historical data of standard of care treatment).

Detailed description:

Arms: arm 1: Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV arm 2: Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
Interventions: intervention 1: vaniprevir intervention 2: peg-IFN intervention 3: ribavirin
Intervention descriptions: intervention 1: vaniprevir capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks intervention 2: peg-IFN 1.5 µg/kg once per week, subcutaneously (SC) for 24 weeks intervention 3: Capsules containing 200 mg ribavirin, orally, 3 to 5 capsules, dosage based on participant weight (600 mg/day to 1000 mg/day), for 24 weeks

Protocol documents:
Clinical trial NCT01545388
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-02-23; Completion date: 2013-03-12
Enrollment: 337 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effect of the addition of metformin once daily (q.d.) or twice daily (b.i.d.) to sitagliptin monotherapy in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with diet/exercise therapy and sitagliptin monotherapy. The primary hypotheses are that the addition of metformin 250 mg b.i.d. or metformin 500 mg q.d. is superior to the addition of placebo on the change from baseline in hemoglobin A1c (HbA1c) at 24 weeks and that the addition of metformin 500 mg q.d. is non-inferior to the addition of metformin 250 mg b.i.d. on the change from baseline in HbA1c at 24 weeks.

Detailed description:

Arms: arm 1: Participants will receive sitagliptin daily (continuing their pre-study dose), 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening. arm 2: Participants will receive sitagliptin daily (continuing their pre-study dose), 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening. arm 3: Participants will receive sitagliptin daily (continuing their pre-study dose), 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
Interventions: intervention 1: Sitagliptin intervention 2: Metformin intervention 3: Metformin intervention 4: Placebo
Intervention descriptions: intervention 1: Sitagliptin, orally, 50 or 100 mg tablet (continuation of the pre-study dose) intervention 2: Metformin, orally, 500 mg daily (single dose; two 250 mg tablets) for 24 weeks intervention 3: Metformin, orally, 500 mg daily (divided dose; 250 mg tablet b.i.d.) for 24 weeks intervention 4: Placebo to match metformin 250 mg tablets, orally, for 24 weeks

Protocol documents:
Clinical trial NCT00541970
Conditions: Infections, Papillomavirus
Keywords: viral infections Human Papillomavirus (HPV) vaccine safety vaccine immunogenicity cervical cancer
Sponsor: GlaxoSmithKline
Start date: 2007-10-17; Completion date: 2013-03-18
Enrollment: 961 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GlaxoSmithKline (GSK) Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. In previous trials this vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities and cervical dysplasia. In this partially-blind study, GSK Biologicals will evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and an alternative dosing when administered in healthy young females aged 9 to 25 years, as compared to the standard HPV vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.

Detailed description:

Arms: arm 1: Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm. arm 2: Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm. arm 3: Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm. arm 4: Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Interventions: intervention 1: Cervarix intervention 2: Placebo
Intervention descriptions: intervention 1: Intramuscular injection, different dosing /schedule intervention 2: Intramuscular injection, different dosing /schedule

Protocol documents:
Clinical trial NCT01008423
Conditions: Proctitis Proctosigmoiditis
Keywords: Proctitis Proctosigmoiditis Ulcerative Salix Budesonide foam Budesonide Rectal Gastrointestinal Colitis UC UP UPS Additional relevant MeSH terms: Proctocolitis Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Rectal Diseases Intestinal Diseases Colonic Diseases Sigmoid Diseases Pathologic Processes Inflammatory Bowel Diseases Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents
Sponsor: Bausch Health Americas, Inc.
Start date: 2009-11-20; Completion date: 2013-03-18
Enrollment: 281 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible participants will be allowed to maintain previously established oral 5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day).

Detailed description:

Arms: arm 1: Participants who were diagnosed with active mild to moderate UP or UPS, will receive 2 milligrams (mg)/25 milliliter (mL) of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks. arm 2: Participants who were diagnosed with active mild to moderate UP or UPS will receive 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.
Interventions: intervention 1: Budesonide intervention 2: Placebo
Intervention descriptions: intervention 1: Budesonide will be administered as per the dose and schedule specified in the respective arm. intervention 2: Placebo matching to budesonide will be administered as per the dose and schedule specified in the respective arm.

Protocol documents:
Clinical trial NCT00655824
Conditions: Arthritis, Rheumatoid
Sponsor: GlaxoSmithKline
Start date: 2008-01-01; Completion date: 2013-03-19
Enrollment: 124 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A 3-year open-label trial for patients who previously participated in Trial Hx-CD20-403 and who fulfill the eligibility criteria for this trial (GEN413) . Th e primary purpose of the trial is to evaluate the long-term effectiveness of repeated courses ( a maximum of 9 treatment courses) of ofatumumab in RA patients who previously received ofatumumab or placebo in Trial Hx-CD20-403.

Detailed description:
All patients who fulfill the eligibility criteria for this trial , will initiate at least one treatment course of ofatumumab, and depending of subsequent worsening in disease activity will be eligible to received further treatment through the 156 week treatment period: a maximum of a further 8 treatment courses will be given at individualized time intervals . The interval between each treatment course will be at least 16 weeks with the last treatment course given no later than week 130 after baseline (Visit 2A).

After each treatment course the patients will attend their next trial visit 8 weeks after Infusion 1, followed by trial visits every 4 weeks up to Week 24, and subsequently every 8 weeks until the next treatment course.

After completing the Treatment Period or after withdrawing from the Treatment Period prematurely patients will be followed every 12 weeks (Follow-up Period) until CD19+ cells \&/or IgG levels have returned to baseline or normal levels.

Arms: arm 1: 1000 mL dilution of 35mls ofatumumab in sterile, pyrogen free, 0.9% NaCl
Interventions: intervention 1: ofatumumab
Intervention descriptions: intervention 1: 1000 mL dilution of 35mls ofatumumab in sterile, pyrogen free, 0.9% NaCl

Protocol documents:
Clinical trial NCT04534465
Conditions: Constipation
Sponsor: Bayer
Start date: 2013-02-13; Completion date: 2013-03-19
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to gather information on the acceptability of a new flavor system with increasing levels of 2, 4, 6 g or higher of the sugar alcohol Mannitol for Polyethylene glycol (PEG) 3350 a drug stimulating bowel movement to pass stool in subjects having infrequent bowel movements. The taste of the various preparations will be measured by use of a rating scale.

Detailed description:

Arms: arm 1: MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) arm 2: MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) arm 3: MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) arm 4: MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) arm 5: MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Interventions: intervention 1: Polyethylene glycol (MiraLAX, BAY81-8430) intervention 2: Mannitol
Intervention descriptions: intervention 1: Oral solution, 17g polyethylene glycol, one time intervention 2: Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time

Protocol documents: