ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01638052
Conditions: Tympanomastoid Surgery Cochlear Implant Mastoidectomy Cholesteatoma
Keywords: Tympanomastoid Surgery Cochlear Implant Mastoidectomy Cholesteatoma Pediatrics Clonidine Bupivacaine Greater Auricular Nerve Block Regional Anesthesia
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Start date: 2006-02-01; Completion date: 2008-04-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators goal is to determine the efficacy and duration of analgesia with the addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of the great auricular nerve in children undergoing tympanomastoid surgery.

Detailed description:
The surgical anesthesia during the operative procedure will be maintained using volatile anesthetics. No prophylactic dexamethasone or ondansetron would be provided to any patients in either group. Anesthesia will be discontinued at the end of the procedure and the patient will be extubated once standard extubation criteria have been met. Patients will be then taken to the postoperative recovery room where they will be evaluated for pain and discomfort by a blinded observer using the CHIPPS (Children and Infants Postoperative Pain Scale). If two consecutive pain scores at 5 minute intervals is \>6, they will be rescued with incremental doses of 0.05 mg/kg of intravenous morphine required to reach a score of \<6. The number of rescue doses as well as the pain scores will be documented. These patients will be also observed for the presence of nausea/vomiting. Any patient who vomits more than two times will be rescued with ondansetron 0.1 mg/kg intravenously. All patients will be continued to be evaluated in the 23 hour unit. Pain and side effects will be assessed for the next 6 hours or until discharge from the 23 hour observation facility. Standard doses of acetaminophen with codeine will be provided for pain relief in the 23 hour observational unit, as well as on discharge. The number of doses of acetaminophen with codeine will be recorded. Time to discharge from the hospital will also be noted. A questionnaire designed to address parent/patient satisfaction will be utilized and will allude to the need for rescue analgesia and the need for any other additional analgesics provided. The use of any additional rescue pain medication will be provided to the families at the time of discharge. A follow-up phone call will be made in 24 hours to note the information provided on the questionnaire.

Arms: arm 1: This is our standard of care concentration arm 2: These are not two separate drugs, but a mixture of Bupivacaine and Clonidine.
Interventions: intervention 1: 0.25% Bupivacaine + Clonidine
Intervention descriptions: intervention 1: Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine

Protocol documents:
Clinical trial NCT01801436
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Bortezomib Velcade
Sponsor: Johnson & Johnson Taiwan Ltd
Start date: 2006-12-01; Completion date: 2008-04-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this post marketing study is to determine the plasma concentration of bortezomib (unchanged drug) to assess the pharmacokinetic (PK - the study of the way a drug enters and leaves the blood and tissues over time) properties in the Taiwanese population. It will also provide expanded access (expanded access, sometimes called "compassionate use," is the use of an investigational drug outside of a clinical trial to treat a participant with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options) to bortezomib for the same group of participants with multiple myeloma (cancer of the types of cells normally found in bone marrow).

Detailed description:
This is an open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than 1 center) study to assess the PK of bortezomib and to provide expanded access to bortezomib for 14 Taiwanese participants with multiple myeloma who have received at least 2 previous lines of therapy (medicine or medical care given to a participant for a disease or condition) and are refractory (not responding to treatment) to or have relapsed (the return of a medical problem) after their last therapy. Eligible participants will receive bortezomib 1.3 milligram (mg) per meter square (m\^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles. Blood samples for PK assessment will be collected on specified time points of Day 1, Day 8, and Day 11 of Cycle 1. Efficacy of the participants will primarily be evaluated by recording 'response to treatment' and 'Karnofsky Performance Status'. Participants' safety will be monitored throughout the study.

Arms: arm 1: Bortezomib 1.3 milligram (mg) per meter square (m\^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
Interventions: intervention 1: Bortezomib
Intervention descriptions: intervention 1: Bortezomib 1.3 mg per (m\^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.

Protocol documents:
Clinical trial NCT02005549
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-02-01; Completion date: 2008-04-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time on study treatment is 3-12 months.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: docetaxel intervention 3: capecitabine [Xeloda]
Intervention descriptions: intervention 1: 15 mg/kg iv on Day 1 of each 3-week cycle, 5 cycles intervention 2: 75 mg/m2 on Day 1 of each 3-week cycle, 6 cycles intervention 3: 950 mg/m2, orally twice daily, evening of Day 1 until morning of Day 15, followed by a 7 day rest period, every 3 weeks

Protocol documents:
Clinical trial NCT02582970
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2005-05-01; Completion date: 2008-04-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.

Detailed description:

Arms: arm 1: Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
Interventions: intervention 1: 5-Fluorouracil intervention 2: Bevacizumab intervention 3: Irinotecan intervention 4: Oxaliplatin
Intervention descriptions: intervention 1: Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor. intervention 2: Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study. intervention 3: Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study. intervention 4: Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.

Protocol documents:
Clinical trial NCT02697188
Conditions: Hypogonadism
Keywords: testosterone male hypogonadism low testosterone
Sponsor: Clarus Therapeutics, Inc.
Start date: 2007-11-01; Completion date: 2008-04-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Determine the serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU) administered once -(QD) and twice-daily (BID) to hypogonadal men.

Detailed description:
Five period cross-over study in which subjects received a single day of dosing in each period. Dosing was either QD or BID with one of two T esters (T-enanthate (TE) or T-undecanoate (TU)). Dosing was within 5 minutes of meals (breakfast and for BID dosing dinner). There was a minimum of a 5-day washout between periods. Subjects were hypogonadal men.

Arms: arm 1: Period 2 - 200 mg T (as TU) QD Period 3 - 200 mg T (as TU) BID (100 mg/dose) Period 4 - 400 mg T (as TU) BID (200 mg/dose) arm 2: Period 1 - 400 mg T (as TE) QD Period 5 - 800 mg T (as TE) BID (400 mg/dose)
Interventions: intervention 1: Testosterone undecanoate intervention 2: Testosterone enanthate
Intervention descriptions: intervention 1: Single-day dose as QD or BID for 3 of 5 crossover periods intervention 2: Single-day dose for 2 of 5 crossover periods

Protocol documents:
Clinical trial NCT00587457
Conditions: Leukemia, Lymphoma, Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Small Lymphocytic Lymphoma, Moxetumomab Pasudotox
Keywords: Chronic Lymphocytic Leukemia Prolymphocytic Leukemia Small Lymphocytic Lymphoma Moxetumomab pasudotox
Sponsor: MedImmune LLC
Start date: 2007-03-07; Completion date: 2008-04-07
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This was a multicenter, Phase 1, standard 3+3 dose-escalation study to evaluate the safety and anti-neoplastic activity of moxetumomab pasudotox in relapsed or refractory participants with chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL) or Small Lymphocytic Lymphoma (SLL).

Detailed description:
This was a multicenter, Phase 1, standard 3+3 dose-escalation study to evaluate the safety and anti-neoplastic activity of CAT-8015 in relapsed or refractory participants with CLL, PLL, or SLL. Participants in the initial dose cohort were to receive CAT-8015 at a dose of 5 microgram per kilogram (mcg/kg) CAT-8015, increasing to 10 mcg/kg in the second dose cohort, and then increasing by 10 mcg/kg increments in subsequent cohorts (that is, to doses of 20, 30, 40, 50, 60 mcg/kg, etc) until a maximum tolerated dose (MTD) was identified. Following identification of the MTD, the MTD cohort was to be expanded to 16 participants.

Arms: arm 1: Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible. arm 2: Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible. arm 3: Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.
Interventions: intervention 1: CAT-8015 5 mcg/kg intervention 2: CAT-8015 10 mcg/kg intervention 3: CAT-8015 20 mcg/kg
Intervention descriptions: intervention 1: Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible. intervention 2: Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible. intervention 3: Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.

Protocol documents:
Clinical trial NCT00516737
Conditions: Migraine
Sponsor: Organon and Co
Start date: 2007-10-03; Completion date: 2008-04-08
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.

Detailed description:

Arms: arm 1: Active Drug arm 2: Matching Pbo Comparator
Interventions: intervention 1: Comparator: rizatriptan benzoate intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack intervention 2: Matching placebo; one dose, treatment of a single migraine attack

Protocol documents:
Clinical trial NCT00701389
Conditions: Migraine Disorders
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-11-20; Completion date: 2008-04-10
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Study to understand the effects of migraine treatments on blood pressure in participants with migraine. The primary hypothesis is that the effect on semi-recumbent mean arterial pressure following the coadministration of telcagepant and sumatriptan is similar to that following administration of sumatriptan alone. That is, the true mean treatment difference (sumatriptan with telcagepant sumatriptan alone) in time-weighted mean arterial pressure for 2.5 hours following dosing is less than 5 mmHg.

Detailed description:

Arms: arm 1: Participants receive the following: Period 1: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A); Period 2: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 3: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D); Period 4: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B). Each dosing period is separated by a 5-day washout. arm 2: Participants receive the following: Period 1: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 2: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D): Period 3: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 4:single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A). Each dosing period is separated by a 5-day washout. arm 3: Participants receive the following: Period 1 :single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C), Period 2: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 3: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A): Period 4: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D). Each dosing period is separated by a 5-day washout. arm 4: Participants receive the following: Period 1: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D), Period 2: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treament A); Period 3: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 4: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C). Each dosing period is separated by a 5-day washout.
Interventions: intervention 1: telcagepant potassium intervention 2: sumatriptan intervention 3: sumatriptan placebo intervention 4: telcagepant potassium placebo
Intervention descriptions: intervention 1: Single oral dose of 2 x 300 mg capsules. intervention 2: single oral dose of 100 mg sumatriptan intervention 3: single oral dose intervention 4: single oral dose of 2 MK-0974 placebo capsules

Protocol documents:
Clinical trial NCT00620503
Conditions: Healthy
Keywords: PK Pharmacokinetics
Sponsor: Repros Therapeutics Inc.
Start date: 2008-02-29; Completion date: 2008-04-30
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
An open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years.

Detailed description:
This is an open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years. Twelve female subjects will each receive a single dose of Proellex®: 25 mg (fed state, formulation A), 25 mg (fed state, formulation B), and 25 mg (fasting state, formulation B); successive dosing will be separated by at least one week intervals from the previous dosing. Blood will be collected prior to taking the dose, and following the dose for 24 hours post-dose. Subjects will be discharged from the study after the last blood sample is obtained after the third dose of Proellex®. Safety will be assessed throughout the study.

Arms: arm 1: Single dose of Proellex 25 mg formulation A, fed arm 2: Single dose of Proellex 25 mg formulation B, fed arm 3: Single dose of Proellex 25 mg formulation B, fasted
Interventions: intervention 1: Proellex 25 mg formulation A intervention 2: Proellex 25 mg formulation B
Intervention descriptions: intervention 1: One Proellex 25 mg formulation A capsule intervention 2: One 25 mg Proellex capsule formulation B administered both fed and fasted

Protocol documents:
Clinical trial NCT00081653
Conditions: Post-Menopausal Osteoporosis
Sponsor: Hoffmann-La Roche
Start date: 2004-05-01; Completion date: 2008-05-01
Enrollment: 719 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ibandronate [Bonviva/Boniva] intervention 2: ibandronate [Bonviva/Boniva]
Intervention descriptions: intervention 1: 150mg po monthly for 3 years intervention 2: 100mg po monthly for 3 years

Protocol documents:
Clinical trial NCT00087646
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2003-09-01; Completion date: 2008-05-01
Enrollment: 948 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Ribavirin intervention 2: Ribavirin intervention 3: peginterferon alfa-2a [Pegasys] intervention 4: peginterferon alfa-2a [Pegasys] intervention 5: peginterferon alfa-2a [Pegasys] intervention 6: peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: 1000/1200mg po daily for 72 weeks intervention 2: 1000/1200mg po daily for 48 weeks intervention 3: 360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks intervention 4: 360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 36 weeks. intervention 5: 180 micrograms sc weekly for 72 weeks intervention 6: 180 micrograms sc weekly for 48 weeks

Protocol documents:
Clinical trial NCT00226811
Conditions: Stomach Neoplasms
Sponsor: Pfizer
Start date: 2006-01-01; Completion date: 2008-05-01
Enrollment: 78 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study consisted of two parts. In Part 1 the study enrolled 38 patients (Step 1 Simon 2 step design) after which Step 2 was opened and the total enrollment target for the study (n=63) was exceeded due to a rapid enrollment (78 patients were entered). Part 2 of the study did not open due to the final overall insufficiency of efficacy observed in 78 patients. Sunitinib (SU011248) was administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg with provision for dose reduction based on tolerability. All patients received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria were met. After discontinuation of treatment, patients were followed up in order to collect information on further antineoplastic therapy and survival.

Detailed description:

Arms: arm 1: 50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed
Interventions: intervention 1: Sunitinib
Intervention descriptions: intervention 1: 50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed

Protocol documents:
Clinical trial NCT00265395
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-12-01; Completion date: 2008-05-01
Enrollment: 1428 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a controlled, randomized, parallel-groups, open-label, multinational study designed to evaluate the efficacy and safety of PEG-Intron® (pegylated interferon alfa-2b) plus Rebetol® (ribavirin) in subjects with chronic hepatitis C. It is designed to evaluate whether 72 weeks of treatment with PEG-Intron plus Rebetol is more effective than 48 weeks of treatment in subjects with Genotype 1 chronic hepatitis C who exhibit a slow response to treatment.

Detailed description:

Arms: arm 1: Slow responders (defined as being polymerase chain reaction \[PCR\] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48. arm 2: Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
Interventions: intervention 1: Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®) intervention 2: Combination of pegylated interferon alfa-2b and ribavirin
Intervention descriptions: intervention 1: 1. Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 48 weeks
2. 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 48 weeks intervention 2: 1. Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strength), subcutaneous, dose of 1.5 micrograms/kg, weekly for 72 weeks.
2. 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 72 weeks

Protocol documents: