ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00314327
Conditions: Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Psychotic Disorder Not Otherwise Specified
Keywords: first episode schizophrenia risperidone
Sponsor: Northwell Health
Start date: 2006-04-01; Completion date: 2013-11-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this project is to evaluate the efficacy of long-acting risperidone for patients with first episode schizophrenia spectrum who did not improve sufficiently with the first antipsychotic medication they tried during their initial treatment trial.

Detailed description:
The goal of the proposed pilot study is to investigate the feasibility and efficacy of the long-acting injectable form of the second generation antipsychotic, risperidone, for the treatment of first episode patients who fail to respond to 12 weeks of treatment with an oral antipsychotic. The rationale for using this long-acting medication is that it eliminates covert non-adherence, which may be a factor in poor response. In addition, pharmacokinetic and pharmacodynamic differences between injectable and oral formulations may result in differences in treatment response favoring the injectable form. Subjects who have not responded sufficiently to treatment with an antipsychotic will be approached for the proposed long-acting risperidone trial. Risperidone treatment will be open label with titration based upon individual response (within FDA approved dose ranges). Treatment will begin with a phase of supplementation with oral risperidone. Subjects will stop their previous antipsychotic, start 2 mg of oral risperidone per day for one day and then increase the dose to 4 mg per day. Subjects who tolerate one week of oral risperidone will then begin injections of 25 mg long-acting risperidone every 2 weeks for a total of 12 weeks. If clinically indicated, the dose may be increased up to a maximum of 50 mg as per FDA guidelines.

Arms: arm 1: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.
Interventions: intervention 1: long-acting injectable risperidone
Intervention descriptions: intervention 1: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.

Protocol documents:
Clinical trial NCT00337077
Conditions: Adenocarcinoma of the Prostate Hormone-refractory Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer
Keywords: Eribulin Mesylate metastatic hormone refractory prostate cancer Halichondrin B Analog
Sponsor: National Cancer Institute (NCI)
Start date: 2006-11-01; Completion date: 2013-11-01
Enrollment: 121 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well eribulin mesylate (E7389; Halichondrin B Analog) works in treating patients with metastatic prostate cancer that did not respond to hormone therapy. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the number of patients with a \> 50% decrease in prostate-specific antigen (PSA) of at least 4 weeks duration in patients with hormone-refractory metastatic prostate cancer treated with E7389 (eribulin mesylate).

SECONDARY OBJECTIVES:

I. Estimate the measurable disease response in patients with measurable disease.

II. Determine the duration of PSA and measurable disease response.

III. Characterize the safety and tolerability of E7389 in these patients.

OUTLINE:

This study enrolled 3 cohorts of patients based on the number of prior chemotherapy regimens received. The 3 cohorts are chemonaive stratum, prior-taxane stratum, and two-prior-chemotherapy stratum. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

Arms: arm 1: Patients receive eribulin mesylate IV over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: eribulin mesylate
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00401817
Conditions: Untreated Mantle Cell Lymphoma
Sponsor: Weill Medical College of Cornell University
Start date: 2007-11-01; Completion date: 2013-11-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective

1\. To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL).

Secondary Objectives

1. To evaluate the response rate and time to disease progression of the RA-CHOP regimen in patients with newly diagnosed MCL.
2. To prospectively characterize the angiogenic profiles of MCL patients during RA-CHOP treatment.

Detailed description:
Bevacizumab administered at 15 mg/kg on day 1 of each of 6 cycles

Rituximab administered 375 mg/m2 on day 3 of each of 6 cycles (with usual premedications)

Standard CHOP chemotherapy administered on day 3 every 21 days (full dose) for 6 cycles of treatment

Once completed six cycles of therapy (\~18 weeks), patients will be evaluated every 3 months for the first year post treatment, then every 6 months until disease progression or death for years 2 through 5 post treatment. Patients who have disease progression will be contacted every 6 months until death to assess for survival status.

Arms: arm 1: Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles
Interventions: intervention 1: Bevacizumab intervention 2: Rituximab intervention 3: CHOP
Intervention descriptions: intervention 1: 15 mg/kg on day 1 of each of 6 cycles intervention 2: Rituximab will be administered prior to CHOP on day 3 of every cycle for a total of 6 cycles.

The dose to be administered is:

Rituximab: 375 mg/m2 intervention 3: Standard CHOP chemotherapy will be administered at full dose every 21 days for a total of 6 cycles. The doses to be used are: Cyclophosphamide: 750 mg/m2 IV on day 3 Doxorubicin: 50 mg/m2 IV on day 3 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 3 Prednisone: 100 mg PO days 3 - 7

Protocol documents:
Clinical trial NCT00424255
Conditions: Neoplasms, Head and Neck
Keywords: Cancer of the Head and Neck Neck cancer Adjuvant Head and neck cancer High-risk head and neck cancer Post-surgery Head cancer
Sponsor: GlaxoSmithKline
Start date: 2006-12-01; Completion date: 2013-11-01
Enrollment: 688 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial comparing the efficacy of adjuvant oral lapatinib versus placebo in high-risk subjects with head and neck cancer following surgery. Lapatinib or placebo will be administered post-operatively in combination with chemoradiotherapy followed by maintenance with lapatinib or placebo for 1 year. The primary goal is to determine if lapatinib is effective at reducing the recurrence of the disease in these high-risk patients.

Detailed description:
A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Phase III Study of Post-Operative Adjuvant Lapatinib or Placebo and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib or Placebo Monotherapy in High-Risk Subjects with Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Arms: arm 1: Adjuvant concurrent chemoradiotherapy plus lapatinib 1500 mg once daily for 6 to 7 weeks, followed by lapatinib 1500 mg once daily for one year.

Chemoradiotherapy=total dose of 66Gy over 6-7 weeks plus cisplatin 100mg/m2 on days 1,2 and 43 of the course of radiotherapy. Lapatinib is also given at 1500 mg once daily for 3-7 days prior to the start of chemoradiotherapy. arm 2: Adjuvant concurrent chemoradiotherapy plus placebo once daily for 6 to 7 weeks, followed by placebo once daily for one year.

Chemoradiotherapy = total dose of 66Gy over 6-7 weeks plus cisplatin 100mg/m2 on days 1,2 and 43 of the course of treatment. Placebo is also given once daily for 3-7 days prior to the start of chemoradiotherapy.
Interventions: intervention 1: Lapatinib intervention 2: Chemoradiation intervention 3: Placebo
Intervention descriptions: intervention 1: Dual ErbB1/2 inhibitor intervention 2: Radiation plus platinum based chemotherapy intervention 3: Placebo

Protocol documents:
Clinical trial NCT00499109
Conditions: Non-Small Cell Lung Cancer
Keywords: RRM1 ERCC1 Customized Chemotherapy
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2007-05-01; Completion date: 2013-11-01
Enrollment: 275 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a clinical research study to evaluate if chemotherapy in the experimental arm (E) results in a better outcome compared to patients in the standard of care arm (C).

2:1 randomization to experimental arm (E) or standard arm (C). In arm E, treatment of dual-agent chemotherapy will be selected based on RRM1 and ERCC1 expression at the protein level. In arm C, treatment of dual-agent chemotherapy will be gemcitabine/carboplatin, i.e., standard of care.

Detailed description:
Before each cycle, blood tests, vital signs, interim medical history, and a physical exam will be performed. Patients will be carefully checked so that immediate intervention can be initiated should an adverse event (i.e. hypersensitivity) occur.

The last treatment cycle according to the study will be cycle #6, or any earlier cycle. Certain tests will be done within 28 days after the last drug infusion. These include physical exam, vital signs, temperature, weight, adverse event evaluation, imaging studies, and blood work.

The study doctor will see the participants every 6 to 8 weeks for at least 12 months after they start treatment. After that, the participants will be followed every 3 months for an additional 24 months.

Arms: arm 1: Experimental Arm E.

Patients received treatment according to gene expression strata with four doublet regimens.

Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.

Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.

High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.

High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group. arm 2: Control Arm C: Gemcitabine and Carboplatin (GCb).

All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed.
Interventions: intervention 1: Docetaxel intervention 2: Vinorelbine intervention 3: Carboplatin intervention 4: Gemcitabine
Intervention descriptions: intervention 1: GD Group: 40 mg/m\^2 on days 1 and 8, every 21 days

DCb Group: 75 mg/m\^2 on day 1

DV Group: 50 mg/m\^2 on days 1 and 15, every 28 days intervention 2: DV Group: 35 mg/m\^2 on days 1 and 15 intervention 3: GCb Group: Area under the curve (AUC) 5 on day 1, every 21 days

DCb Group: AUC 6 on day 1, every 21 days

Control Arm: Patients received up to 6 cycles, and no maintenance therapy was allowed. intervention 4: GCb Group: 1,250 mg/m\^2 on days 1 and 8

GD Group: 1,250 mg/m\^2 on days 1 and 8

Control Arm: Patients received up to 6 cycles, and no maintenance therapy was allowed.

Protocol documents:
Clinical trial NCT00504894
Conditions: Healthy
Keywords: N/A healthy volunteers
Sponsor: Weill Medical College of Cornell University
Start date: 2007-03-01; Completion date: 2013-11-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study involves 60 healthy volunteers aged between 18 and 50 recruited from the general community. It involves doing a set of simple memory tests while inside a fMRI machine. The subject is given a very low dose of an anesthetic drug intravenously while in the scanner. The subject then sees a sequence of pictures on a screen, and presses a button if they remember seeing the picture before. While this is happening, the scanner will be capturing images that tell us what parts of the brain are active. Hypothesis: patterns of hippocampal and amygdala activation during the encoding and retrieval of memory,as measured by fMRI, will be altered by intravenous anesthetics such that suppression of hippocampal and amygdala activities will be dissociable. This dissociation pattern will be different between the drugs propofol and thiopental.

Detailed description:
Background: Subclinical doses of propofol produce anterograde amnesia, characterized by an early failure of memory consolidation. It is unknown how propofol affects the amygdala-dependent emotional memory system, which modulates consolidation in the hippocampus in response to emotional arousal and neurohumoral stress. We present an event-related functional magnetic resonance imaging study of the effects of propofol on the emotional memory system in human subjects.

Methods: Sixty healthy subjects were randomized to receive propofol, at an estimated brain concentration of 0.90 μgml-1, thiopental, at an estimated brain concentration of 3.0 μgml-1, or placebo. During drug infusion, emotionally arousing and neutral images were presented in a continuous recognition task, while blood-oxygen-level-dependent activation responses were acquired. After a drug-free interval of 2 h, subsequent memory for successfully encoded items was assessed. Imaging analysis was performed using statistical parametric mapping and behavioural analysis using signal detection models.

Arms: arm 1: Placebo given in low dose to gauge subject's responses to visual stimuli. arm 2: Propofol given at 0.90 μgml-1 to gauge subject's responses to visual stimuli. arm 3: Thiopental given at 3.0 μgml-1 to gauge subject's responses to visual stimuli.
Interventions: intervention 1: Placebo intervention 2: Propofol intervention 3: Thiopental
Intervention descriptions: intervention 1: A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine. intervention 2: A low dose of propofol 0.90 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine. intervention 3: A low dose of thiopental 3.0 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.

Protocol documents:
Clinical trial NCT00517530
Conditions: Lymphoma
Sponsor: Hoffmann-La Roche
Start date: 2007-09-01; Completion date: 2013-11-01
Enrollment: 134 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective for the phase I part of the study is to investigate the safety and tolerability of escalating intravenous (IV) doses of obinutuzumab given as monotherapy in participants with CD20+ (tumor-infiltrating lymphocytic) Malignant Disease, including B-cell chronic lymphocytic leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL). The primary objective for the phase II part of the study is to investigate the efficacy and safety of one dose of obinutuzumab in participants with relapsed/refractory CLL and NHL that is, in turn, either indolent (iNHL) or aggressive (aNHL).

It is an open label dose escalating study in phase I and open label in phase II, but the two doses in iNHL \& aNHL are randomized (to high or low dose of the same open label treatment). CLL was not randomized as only one dose level was used.

Participants with a response who might gain additional benefit from being treated again in the opinion of the investigator may be enrolled in a Retreatment Period.

Detailed description:

Arms: arm 1: Participants in this NHL arm received multiple ascending doses between 50 and 2000 mg via intravenous infusion of obinutuzumab. arm 2: Participants in this CLL arm received multiple ascending doses between 400 and 2000 mg via intravenous infusion of obinutuzumab. arm 3: Participants in this iNHL arm received an intravenous infusion of obinutuzumab 400 mg on Days 1 and 8 of Cycle 1 and obinutuzumab 400 mg on Day 1 of Cycles 2-8 for a maximum of 8 cycles and 9 infusions. Each cycle was 21 days. arm 4: Participants in this iNHL arm received an intravenous infusion of obinutuzumab 1600 mg on Days 1 and 8 of Cycle 1 and obinutuzumab 800 mg on Day 1 of Cycles 2-8 for a maximum of 8 cycles and 9 infusions. Each cycle was 21 days. arm 5: Participants in this aNHL arm received an intravenous infusion of obinutuzumab 400 mg on Days 1 and 8 of Cycle 1 and obinutuzumab 400 mg on Day 1 of Cycles 2-8 for a maximum of 8 cycles and 9 infusions. Each cycle was 21 days. arm 6: Participants in this aNHL arm received an intravenous infusion of obinutuzumab 1600 mg on Days 1 and 8 of Cycle 1 and obinutuzumab 800 mg on Day 1 of Cycles 2-8 for a maximum of 8 cycles and 9 infusions. Each cycle was 21 days. arm 7: Participants in this CLL arm received an intravenous infusion of obinutuzumab 1000 mg on Days 1, 8, and 15 of Cycle 1 and obinutuzumab 1000 mg on Day 1 of Cycles 2-8 for a maximum of 8 cycles and 10 infusions. Each cycle was 21 days. arm 8: Participants who might benefit from retreatment who were allowed to be treated again via intravenous infusion of obinutuzumab at the request of the investigator.
Interventions: intervention 1: Obinutuzumab
Intervention descriptions: intervention 1: Obinutuzumab was provided in single-dose glass vials as a freeze-dried powder.

Protocol documents:
Clinical trial NCT00520013
Conditions: Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Papillary Serous Mullerian Tumor Clear Cell Mullerian Tumor
Sponsor: Dana-Farber Cancer Institute
Start date: 2007-08-01; Completion date: 2013-11-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to evaluate how patients with newly diagnosed advanced ovarian, fallopian tube, primary peritoneal cancer and papillary serous or clear cell mullerian tumors respond to consolidation therapy with Avastin and erlotinib or Avastin alone over 1 year. These drugs have been used in the treatment of other types of cancers and information from those studies suggests that these agents may help to treat the cancers studied here.

Detailed description:
Objectives:

Primary To examine the progression free survival (PFS) of Avastin and Erlotinib (AE) or Avastin (A) as consolidation therapy.

Secondary To examine the toxicity between the two consolidative regimens AE vs. A. To assess the response rate of CTA.

STATISTICAL DESIGN This study uses a randomized selection design. Both consolidation treatment arms are deemed experimental and are compared against a historical control \[McGuire WP et al. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. NEJM 1996: 334:1-6. PMID:7494563\]. With 30 patients in a given arm and 6 months of follow-up, there was 80% power to detect a 61.5% increase in median PFS from 13 months to 21 months assuming 1-sided 10% significance.

Arms: arm 1: Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year. arm 2: Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year. arm 3: Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.

Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.

Consolidation: None
Interventions: intervention 1: bevacizumab intervention 2: erlotinib intervention 3: paclitaxel intervention 4: carboplatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00539110
Conditions: Sleep Burns
Sponsor: Shriners Hospitals for Children
Start date: 2009-12-01; Completion date: 2013-11-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To examine sleep changes following therapeutic drug interventions designed to promote sleep.

Detailed description:

Arms: arm 1: zolpidem or ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization arm 2: ramelteon or zolpidem dosed at 2200 and 0200 per the feeding tube depending on randomization
Interventions: intervention 1: zolipidem intervention 2: ramelteon
Intervention descriptions: intervention 1: zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization intervention 2: ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization

Protocol documents: