ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01033448
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2009-12-01; Completion date: 2013-06-01
Enrollment: 59 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: COPEGUS intervention 2: peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: COPEGUS 800 mg or 1000-1200 mg po for 24 weeks intervention 2: PEGASYS 180 micrograms sc once weekly for 24 weeks

Protocol documents:
Clinical trial NCT01075100
Conditions: Metastatic Breast Cancer
Keywords: metastatic breast cancer
Sponsor: US Oncology Research
Start date: 2010-01-01; Completion date: 2013-06-01
Enrollment: 103 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Ixabepilone adds significantly to the antitumor effectiveness of capecitabine in both ER+ and triple negative breast cancer. Ixabepilone has substantial antitumor activity in taxane-refractory patients and novel combinations are needed in this poor prognosis population. Carboplatin in combination with gemcitabine or paclitaxel has activity in metastatic breast cancer (MBC); there is also demonstrated activity of the gemcitabine/carboplatin combination in the ER+ versus triple negative subsets. A Phase I study of ixabepilone plus carboplatin in solid tumor patients demonstrated the safety of this combination at the doses and schedule proposed for this Phase II trial (BMS data on file).

Detailed description:
This is a Phase II, open label, nonrandomized, parallel, noncomparative, study of 2 groups (as stratified below). All patients will receive ixabepilone 20 mg/m2 on Days 1 and 8 and carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle. Patients will be stratified by either hormone receptor positive \[ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-\]- (n=50) or triples negative ER-/PR-/HER2- (n=53). If one group fulfills their accrual goal first, registration into that strata will be stopped and only patients meeting stratification requirements for the other group will be registered.

Arms: arm 1: Subjects will receive ixabepilone and carboplatin on Days 1 and 8 of each 21-day cycle.
Interventions: intervention 1: Ixabepilone intervention 2: Carboplatin
Intervention descriptions: intervention 1: 20 mg/m2 on Days 1 and 8 intervention 2: carboplatin AUC=2.5 on Days 1 and 8

Protocol documents:
Clinical trial NCT01092832
Conditions: Candidiasis
Keywords: Invasive Candidiasis Candidemia Esophageal Candidiasis
Sponsor: Pfizer
Start date: 2010-10-01; Completion date: 2013-06-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
The purpose of this study is to determine whether voriconazole is safe and effective for the treatment of serious Candida infection and Candida infection of the esophagus in children and adolescents.

Detailed description:

Arms: arm 1: All subjects in this study will receive active voriconazole in an open-label fashion; there is no comparator in this study.
Interventions: intervention 1: voriconazole
Intervention descriptions: intervention 1: Subjects 12 - \<18 yrs (excluding subjects 12 - 14 yrs weighing \<50kg): For IC, the loading dose is 6 mg/kg IV q12h on Day 1, followed by 4 mg/kg IV q12h thereafter. Oral therapy, if given, will be administered at a dose of 200 mg q12h. For EC, no loading dose is required, and subjects will be initiated on 3 mg/kg IV q12h. Oral therapy, if given, will be administered at a dose of 200 mg q12h.

Subjects 2 - \<12 yrs, and subjects 12 - 14 weighing \<50kg: For IC, the loading dose is 9 mg/kg IV q12h on Day 1, followed by 8 mg/kg IV q12h thereafter. For EC, no loading dose is required, and subjects will be initiated on 4 mg/kg IV q12. Oral therapy, if given, will be administered at a dose of 9 mg/kg q12h (maximum initial dose of 300 mg).

Subjects will be treated for a minimum of 14 days for invasive candidiasis/candidemia or a minimum of 7 days for esophageal candidiasis. Subjects will be treated for up to a maximum of 42 days.

Protocol documents:
Clinical trial NCT01123356
Conditions: Chronic Lymphocytic Leukemia
Keywords: Relapsed chronic lymphocytic leukemia
Sponsor: Medical University of South Carolina
Start date: 2010-05-01; Completion date: 2013-06-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research is to evaluate the safety and effectiveness of the drugs lenalidomide and ofatumumab in the treatment of chronic lymphocytic leukemia (CLL).

Detailed description:

Arms: arm 1: Single arm, non randomized study

Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.

* Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
* Treatment to be administered for up to 6 cycles
Interventions: intervention 1: Ofatumumab intervention 2: Lenalidomide
Intervention descriptions: intervention 1: * Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)
* Treatment to be administered for up to 6 cycles intervention 2: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)

Protocol documents:
Clinical trial NCT01124786
Conditions: Metastatic Pancreatic Adenocarcinoma
Keywords: cancer metastatic pancreatic pancreas adenocarcinoma gemcitabine human equilibrative nucleoside transporter-1 (hENT1) CO-1.01 CO-101 CO101 Stage 4 Stage IV
Sponsor: Clovis Oncology, Inc.
Start date: 2010-05-01; Completion date: 2013-06-01
Enrollment: 367 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.

Detailed description:
Pancreatic cancer is a very serious form of cancer. The majority of patients present with unresectable disease, and the condition is often not diagnosed until the cancer is relatively advanced. The standard first-line treatment for patients with unresectable pancreatic cancer is gemcitabine monotherapy. Unfortunately many of these patients fail to derive benefit from this treatment. No clinical or molecular marker has been established to predict benefit from gemcitabine therapy, so patients are treated empirically until evidence of disease progression or worsening performance status.

The potential for human equilibrative nucleoside transporter-1 (hENT1) expression to predict survival in gemcitabine-treated patients has been studied, and data suggest that patients with low levels of tumor cell hENT1 expression derive less benefit from gemcitabine treatment than patients with high levels of tumor cell hENT1 expression. These data support the hypothesis to be tested in this study that patients with pancreatic tumors expressing low levels of hENT1 will derive minimal benefit from gemcitabine, but will receive benefit from CO-1.01 (gemcitabine elaidate) which enters tumor cells in a hENT1-independent fashion.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CO-1.01 intervention 2: Gemcitabine
Intervention descriptions: intervention 1: 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks intervention 2: 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks

Protocol documents:
Clinical trial NCT01134016
Conditions: Non-small Cell Lung Cancer
Keywords: Lung cancer NSCLC
Sponsor: Golden Biotechnology Corporation
Start date: 2010-12-01; Completion date: 2013-06-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A phase I study to determine the maximum tolerable dose (MTD) and to evaluate pharmacokinetic, safety/tolerability and efficacy profiles of antroquinonol (Hocena®) in non-small cell lung cancer (NSCLC) subjects refractory to conventional treatment modalities

Detailed description:
1. Antroquinonol, a novel cyclohexenone compound, is a purified compound from extract of Antrodia camphorata.
2. The pharmacological effects of antroquinonol were postulated to exert its antitumorigenesis effects through interactions to primary targets of epidermal growth factor receptor (EGFR)/Akt/mitogen-activated protein kinase (MAPK).
3. In vivo study in NOD/SCID mice with A549 subcutaneous xenografts consistently showed tumor growth suppression after 2 weeks of oral 30 and 60 mg/kg antroquinonol treatment.

Arms: arm 1: 6 dose levels, Dose Level 1 (4 weeks) : 50 mg Antroquinonol; Dose Level 2 (4 weeks) : 100mg Antroquinonol; Dose Level 3 (4 weeks) : 200mg Antroquinonol; Dose Level 4 (4 weeks) : 300mg Antroquinonol; Dose Level 5 (4 weeks) : 450mg Antroquinonol; Dose Level 6 (4 weeks) : 600mg Antroquinonol.

A maximum of 36 patients were planned based on a criteria of a maximum of 6 patients per cohort: 1 to 6 patients were planned for each dose group in the accelerated phase; 3 to 6 patients for each dose group in the standard phase .

The method of dose escalation in the accelerated titration phase continued to the next higher dose level until a patient experienced MT or a DLT. Standard titration phase start with 3+3 patients. Dose escalation proceeded sequentially between cohorts.
Interventions: intervention 1: Antroquinonol
Intervention descriptions: intervention 1: Antroquinonol was taken orally, daily, within 15 minutes after a breakfast at the assigned dose level: 50, 100, 200, 300, 450, 600 mg/day for 4 weeks.

Dose Level 1 (4 weeks) : 50 mg Antroquinonol; Dose Level 2 (4 weeks) : 100mg Antroquinonol; Dose Level 3 (4 weeks) : 200mg Antroquinonol; Dose Level 4 (4 weeks) : 300mg Antroquinonol; Dose Level 5 (4 weeks) : 450mg Antroquinonol; Dose Level 6 (4 weeks) : 600mg Antroquinonol.

The accelerated phase ended when either 1 DLT or MT was observed to start standard phase. Study ended when reach the highest dose level or DLT founded.

Protocol documents:
Clinical trial NCT01163214
Conditions: Postoperative Pain Knee Replacement Arthroplasty
Sponsor: Mark J. Spangehl, M.D.
Start date: 2010-07-01; Completion date: 2013-06-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare two methods of postoperative pain management in patients undergoing total knee replacement.

Detailed description:
Patients undergoing total knee replacement will be assigned at random to receive one of two methods of postoperative pain management. Patients assigned to nerve block will receive regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block. Patients assigned to periarticular injection will receive periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Additionally, all patients will be given a standardized combination of oral analgesic medications preoperatively and postoperatively. All patients will receive a posterior stabilized total knee replacement through an medial parapatellar approach.

Arms: arm 1: Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block. arm 2: Injection combination prior to skin closure.
Interventions: intervention 1: Nerve Block intervention 2: Periarticular Injection
Intervention descriptions: intervention 1: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine. intervention 2: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.

Protocol documents:
Clinical trial NCT01165216
Conditions: Non-Small Cell Lung Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2010-09-01; Completion date: 2013-06-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study was to establish the recommended dose of ipilimumab administered in combination with paclitaxel and carboplatin in Japanese patients with nonsmall-cell lung cancer.

Detailed description:

Arms: arm 1: Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m\^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses). arm 2: Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m\^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
Interventions: intervention 1: Ipilimumab, 3 mg intervention 2: Ipilimumab, 10 mg intervention 3: Paclitaxel intervention 4: Carboplatin
Intervention descriptions: intervention 1: Intervenous (IV) injection, administered every 3 weeks for up to 6 cycles intervention 2: IV injection, administered every 3 weeks for up to 6 cycles intervention 3: IV injection, 175 mg/m\^2, administered every 3 weeks for up to 6 cycles intervention 4: IV injection, AUC=6, administered every 3 weeks for up to 6 cycles. (AUC=area under the concentration curve)

Protocol documents:
Clinical trial NCT01189292
Conditions: Thyroidectomy Thyroid Diseases
Keywords: postoperative nausea and vomitus PONV thyroid surgery
Sponsor: Cantonal Hospital of St. Gallen
Start date: 2011-01-01; Completion date: 2013-06-01
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is to compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy.

Detailed description:

Arms: arm 1: Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®) arm 2: None
Interventions: intervention 1: Dexamethasone intervention 2: NaCl 0.9%
Intervention descriptions: intervention 1: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery intervention 2: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery

Protocol documents:
Clinical trial NCT01196052
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2010-10-01; Completion date: 2013-06-01
Enrollment: 153 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer. Patients received T-DM1 3.6 mg/kg intravenously on Day 1 of each 3-week cycle, for up to 17 cycles.

Detailed description:

Arms: arm 1: Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
Interventions: intervention 1: Trastuzumab emtansine
Intervention descriptions: intervention 1: Trastuzumab emtansine was provided as a single-use lyophilized formulation in a glass vial.

Protocol documents:
Clinical trial NCT01202175
Conditions: Pre-hypertension Hypertension
Keywords: Genetic risk of hypertension
Sponsor: University of California, San Diego
Start date: 2010-07-01; Completion date: 2013-06-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators aim to evaluate subjects at high risk of future development of hypertension, those with a family history of hypertension and/or that already have high normal(SBP 120-139 mmHg or DBP 80-89 mmHg) blood pressure. The investigators plan to investigate whether these subjects have the same markers (such as microscopic protein in the urine or C-reactive protein in the blood) in the blood and urine that people with high blood pressure have, and whether they are improved before and after taking the beta-blocker nebivolol.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Nebivolol
Intervention descriptions: intervention 1: Oral nebivolol 2.5-5mg once daily

Protocol documents:
Clinical trial NCT01202656
Conditions: Infertility, Female
Keywords: Fertility Agents, Female In vitro fertilization
Sponsor: Center for Human Reproduction
Start date: 2010-09-01; Completion date: 2013-06-01
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This a trial designed to test whether granulocyte colony stimulating factor (G-CSF, Neupogen) can increase the rate of embryo implantation following IVF and embryo transfer. Preliminary data at the Center for Human Reproduction(CHR) and elsewhere suggest that intrauterine infusion of G-CSF can improve endometrial development and can increase implantation rates of embryos.

Detailed description:
Objective: To investigate the effect of treatment with CSF on pregnancy rates in routine in vitro fertilization (IVF).

Design: Double blinded crossover randomized controlled clinical trial

Setting: Academically affiliated private infertility centers

Subjects: Normal female IVF patients 18-38 years old, and above age 38 years, who are willing to be randomized to treatment.

Interventions: Subjects receive transvaginally, utilizing an insemination catheter, a slow uterine lavage with G-CSF (Neupogen), 300ug (in 1 ml); controls receive saline. Patients who do not conceive will, after one month washout time, continue treatment in the opposite study arm.

Main Outcome Measures: Implantation rate(IR) and pregnancy rates.

Second Outcome Measures: Live birth rates and miscarriage rates.

Statistical and Power considerations: Analysis will be by regression with IR as dependent and treatment as independent. Results will be adjusted by age and indices of ovarian reserve, such as antiMulerian Hormone (AMH). Presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, 120 women, producing about 200 embryos in each study arm, will have to be recruited for 80% power and alpha of 0.05.

Arms: arm 1: G-CSF (Granulocyte colony stimulating factor) arm 2: Normal Saline
Interventions: intervention 1: G-CSF intervention 2: Saline
Intervention descriptions: intervention 1: One infusion of G-CSF 300 units administered by intrauterine infusion intervention 2: intrauterine saline infusion 1 cc

Protocol documents:
Clinical trial NCT01203189
Conditions: Seborrheic Dermatitis
Keywords: dandruff, flaky scalp
Sponsor: St. Louis University
Start date: 2010-09-01; Completion date: 2013-06-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aims of this study are to compare the effectiveness of antifungal foam versus antifungal shampoo and determine patient compliance and satisfaction with both vehicles among African American females with dandruff practicing less than once weekly hair washing.

Detailed description:
A wide variety of topical vehicles are available for medications that treat scalp disorders. Proper vehicle selection is important when managing scalp conditions, such as seborrheic dermatitis, because the efficacy of these treatments depends largely on compliance and the amount of active ingredient delivered to the scalp. It is therefore important to prescribe vehicles that are easy to apply and cause the least amount of disruption to the patients' pre-existing hair care practices. One of the most common rate limiting hair care practices among different cultures is wash frequency. Literature shows African American women are more likely to wash their hair less than once weekly versus Caucasian women. We hypothesize certain vehicles, such as foam preparations which do not require hair washing, will be more efficacious in African American women with seborrheic dermatitis than shampoo preparations.

Arms: arm 1: Subjects in the S group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo. arm 2: Subjects in the F group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. arm 3: apply ketoconazole 2% foam to scalp twice daily for four weeks. Subjects in the Shampoo group will be able to cross over into the Foam group if the TDSS score does not improve by 60% at the end of the four week treatment period using shampoo.
Interventions: intervention 1: ketoconazole 2% foam intervention 2: ketoconazole 2% shampoo
Intervention descriptions: intervention 1: Subjects in the Foam (F) group will apply ketoconazole 2% foam to the scalp twice daily for four weeks. intervention 2: Subjects in the Shampoo (S) group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.

Protocol documents: