ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00287989
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2004-11-01; Completion date: 2009-05-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib together with paclitaxel and carboplatin may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying two different doses of erlotinib when given together with paclitaxel and carboplatin to compare how well they work in treating patients with stage III, stage IV, or recurrent non-small cell lung cancer.

Detailed description:
OBJECTIVES:

* Compare the major objective response (complete and partial response) rates in patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with high- versus low-dose erlotinib hydrochloride combined with paclitaxel and carboplatin.
* Compare the duration of response, time to progression, and survival of patients treated with these regimens.
* Characterize and compare the toxicities of these regimens.
* Determine the recommended phase III dose of erlotinib hydrochloride.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral high-dose erlotinib hydrochloride on days 1 and 2. Patients also receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 3.
* Arm II: Patients receive oral low-dose erlotinib hydrochloride, paclitaxel, and carboplatin as in arm I.

In both arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Arms: arm 1: Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2 arm 2: Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2 arm 3: Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
Interventions: intervention 1: Carboplatin intervention 2: erlotinib hydrochloride intervention 3: Paclitaxel intervention 4: erlotinib hydrochloride
Intervention descriptions: intervention 1: None intervention 2: 150mg intervention 3: 200mg/m2 intervention 4: 1500mg

Protocol documents:
Clinical trial NCT00289016
Conditions: Melanoma
Keywords: gene transfer gene therapy oncolytic virus GM-CSF melanoma
Sponsor: BioVex Limited
Start date: 2005-12-01; Completion date: 2009-05-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study was to assess the clinical efficacy of talimogene laherparepvec in terms of tumor response rates.

Detailed description:

Arms: arm 1: Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
Interventions: intervention 1: Talimogene Laherparepvec
Intervention descriptions: intervention 1: Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection

Protocol documents:
Clinical trial NCT00291330
Conditions: Thromboembolism
Sponsor: Boehringer Ingelheim
Start date: 2006-02-01; Completion date: 2009-05-01
Enrollment: 2564 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.

Detailed description:

Arms: arm 1: twice daily arm 2: prn to maintain INR (2-3)
Interventions: intervention 1: dabigatran etexilate 150 mg intervention 2: warfarin (INR 2-3)
Intervention descriptions: intervention 1: twice daily intervention 2: prn to maintain INR (2-3)

Protocol documents:
Clinical trial NCT00292370
Conditions: Combat Disorders Stress Disorders, Post-Traumatic
Keywords: Atypical Antipsychotics Controlled Trial Paroxetine Quetiapine Stress Disorders, Post-Traumatic Treatment refractory Treatment resistant
Sponsor: VA Office of Research and Development
Start date: 2006-01-01; Completion date: 2009-05-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the response of veterans with PTSD without an optimal response to paroxetine to quetiapine augmentation versus placebo.

Detailed description:
This is a two-site study designed to evaluate the efficacy and safety of quetiapine augmentation of paroxetine treatment in veterans with PTSD who have failed to respond to paroxetine treatment.

In Phase I, eligible patients will take open-label paroxetine (up to 60 mg daily) for 8 weeks. Patients who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for the second phase. In Phase II, patients will continue taking open-label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) or placebo for 8 weeks in a double-blind fashion.

Arms: arm 1: Open-label Paroxetine In Phase I, eligible participants will take open-label (OL) Paroxetine (up to 60 mg) daily for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II. arm 2: In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion. arm 3: In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
Interventions: intervention 1: Open Label (OL) Paroxetine intervention 2: Placebo intervention 3: Quetiapine
Intervention descriptions: intervention 1: Open-label Paroxetine intervention 2: Double-blind placebo taken with OL paroxetine intervention 3: Double-blind quetiapine taken with OL paroxetine

Protocol documents:
Clinical trial NCT00313144
Conditions: Alpha1-antitrypsin Deficiency
Sponsor: Baxalta now part of Shire
Start date: 2006-06-09; Completion date: 2009-05-01
Enrollment: 127 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are to evaluate the health outcomes of Alpha 1-Antitrypsin (AAT)-deficient subjects who are initiating treatment with ARALAST on patient-related outcomes (PRO), i.e., health-related quality of life (HRQoL), healthcare resource utilization (HCRU), and various laboratory analyses to evaluate the safety of long-term administration of ARALAST.

Up to 120 subjects will be enrolled and assessed for HRQoL and HCRU at baseline and every 6-months thereafter, for 2 years. A subset of subjects will be enrolled into the blood draw portion of the study, which will also include assessments of antibodies to ARALAST, and chemistry panel. Subjects will be treated according to the prescribing (attending) physician's instructions based on the prescribing information given in the ARALAST package insert.

Detailed description:

Interventions: intervention 1: ARALAST Alpha1-Proteinase Inhibitor
Intervention descriptions: intervention 1: Weekly ARALAST infusions for 2 years, dose and mode of administration as prescribed by the physician

Protocol documents:
Clinical trial NCT00316186
Conditions: Lung Cancer, Small Cell
Keywords: chemonaive small cell lung cancer untreated Lung cancer HYCAMTIN first-line extensive disease
Sponsor: GlaxoSmithKline
Start date: 2005-06-01; Completion date: 2009-05-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study was designed to find the safest and most effective dose of a combination of two chemotherapy drugs, Hycamtin® (topotecan) and Paraplatin® (carboplatin), in people with extensive disease small cell lung cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: topotecan intervention 2: carboplatin
Intervention descriptions: intervention 1: Hycamtin and Carboplatin as first-line treatment of chemonaive subjects with EX-SCLC. intervention 2: Hycamtin and Carboplatin as first-line treatment of chemonaive subjects with EX-SCLC.

Protocol documents:
Clinical trial NCT00337467
Conditions: Human Immunodeficiency Virus (HIV) Infections
Keywords: HIV-Infected Patients Evidencing Virologic Suppression
Sponsor: Bristol-Myers Squibb
Start date: 2006-06-01; Completion date: 2009-05-01
Enrollment: 61 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced protease inhibitor therapy can maintain virologic suppression without a marked increase in virologic failure.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Atazanavir + Ritonavir
Intervention descriptions: intervention 1: Capsules, Oral, ATV 300mg + RTV 100mg, once daily, 96 weeks

Protocol documents:
Clinical trial NCT00349466
Conditions: Keratoconjunctivitis Sicca
Keywords: Keratoconjunctivitis Sicca KCS Dry Eye
Sponsor: Can-Fite BioPharma
Start date: 2007-01-01; Completion date: 2009-05-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2, randomized, double-masked, placebo-controlled, parallel-group study in adult males and females, aged 18 years and over, with a diagnosis of moderate-to-severe keratoconjunctivitis sicca (KCS). Patients will be randomized to receive either CF101 1 mg or matching placebo, given orally every 12 hours (q12h) for 12 weeks. A Screening Period of up to 4 weeks that includes a 2-week run-in period will precede a 12-week treatment period, followed by a 2-week follow-up period.

Detailed description:
At a Screening Visit, patients who provide written informed consent will have screening procedures performed, including a complete medical history, medication history, physical examination, including height, weight, sitting blood pressure, pulse rate and temperature, and clinical laboratory tests. Disease activity will be assessed using tear meniscus (TM) height, tear break-up time (BUT), fluorescein staining (FS), Schirmer test, and the Dry Eye Symptom Score (DESS). Doses of artificial tears must be stable for \>2 weeks prior to the Screening Visit.

Eligible patients will begin a 2-week run-in period, during which time they will be instructed to discontinue use of all topical ophthalmic medications except for lubricant eye drops. Patients who successfully complete the 2-week run-in period will be randomized to their assigned medication (CF101 1 mg or matching placebo) to be taken orally every q12h for 12 weeks. Patients will return for assessments and a new supply of study medication at Weeks 2, 4, 8 and 12, and at Week 14 for a final follow-up assessment.

Arms: arm 1: CF101 1 mg given orally every 12 hours for 12 weeks arm 2: Placebo given orally every 12 hours for 12 weeks
Interventions: intervention 1: CF101 intervention 2: Placebo
Intervention descriptions: intervention 1: Orally CF101 1mg intervention 2: Orally matching Placebo

Protocol documents:
Clinical trial NCT00354029
Conditions: Hemorrhoids Pain
Keywords: hemorrhoids hemorrhoidectomy S (+) ketamine pain
Sponsor: Asker & Baerum Hospital
Start date: 2006-08-01; Completion date: 2009-05-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine reduces the amount and degree of postoperative pain.

Furthermore the purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine effects cognitive function in the early postoperative period.

Detailed description:
The mechanism of development of postoperative pain is complex. Central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. Several studies have shown, that S (+) ketamine can be effective to reduce sensitization and postoperative pain. Ketamine (2-O-chlorophenyl-2-methylamino cyclohexanone) is a N-Methyl-D-Aspartat (NMDA) receptor antagonist. S (+) ketamine has a four times stronger affinity to the NMDA receptor compared to R (-) ketamine. The duration of action for S (+) ketamine is shorter than R (-) ketamine and it has fewer side-effects.

The purpose of this study is to compare the analgetic effect of pregabalin and placebo used in the perioperative period.

The hypothesis is that perioperative intravenous S (+) ketamine gives significant better analgesia than placebo without effecting cognitive function.

The study is including patients undergoing hemorrhoidectomy.

Arms: arm 1: Saline 0,9% arm 2: None
Interventions: intervention 1: S (+) Ketamine intervention 2: Placebo
Intervention descriptions: intervention 1: 0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery intervention 2: isotonic saline

Protocol documents:
Clinical trial NCT00363168
Conditions: Choroidal Neovascularization
Keywords: Hemorrhagic Choroidal Neovascularization
Sponsor: Johns Hopkins University
Start date: 2006-08-01; Completion date: 2009-05-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to look at the effects of an experimental drug, ranibizumab, on a condition called "predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)" due to wet age-related macular degeneration.

A predominantly hemorrhagic CNV lesion is diagnosed when at least 50% of the choroidal neovascular lesion is occupied by blood under the retina. We want to find out if injections of ranibizumab into the eye will help patients with this condition.

Detailed description:
This study is a randomized, interventional case series. A total of 10 patients, seen in the Retina Division of the Wilmer Eye Institute, will be enrolled. Subjects will be randomized to either 0.3 mg or 0.5 mg intravitreal injections of ranibizumab, which will be performed monthly for 3 doses. Further monthly injections are at the discretion of the examiner, and may be withheld if there is lack of continued improvement (defined as lack of improvement of at least 5 letters on an eye chart compared with 2 previous consecutive visits or lack of decrease of the retinal center point thickness of at least 50 microns compared with 2 previous consecutive visits) or complete success (defined as visual acuity of 20/20 or better or retinal center point thickness \<225 microns).

Arms: arm 1: 0.3 mg/0.05 ml dose of ranibizumab arm 2: 0.5 mg/0.05 ml dose of ranibizumab
Interventions: intervention 1: Ranibizumab intervention 2: Ranibizumab
Intervention descriptions: intervention 1: 0.3 mg/0.05 ml dose intervention 2: 0.5 mg/0.05 ml dose

Protocol documents:
Clinical trial NCT00371345
Conditions: Breast Cancer Metastasis
Keywords: Recurrent, locally-advanced, or metastatic breast cancer
Sponsor: Bristol-Myers Squibb
Start date: 2006-12-01; Completion date: 2009-05-01
Enrollment: 92 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer

Detailed description:

Arms: arm 1: Participants with either a Human epidermal growth factor (Her2/neu)-amplified tumor type or ER and/or PgR positive tumor types received oral dasatinib twice daily (BID).
Interventions: intervention 1: Dasatinib intervention 2: Dasatinib 100 mg
Intervention descriptions: intervention 1: Tablets, Oral, 70 mg, twice daily, as long as the participant benefits (average \<6 months) intervention 2: Tablets, Oral, 100mg, twice daily, as long as the participant benefits (average \<6 months)

Protocol documents:
Clinical trial NCT00402051
Conditions: Non-Small-Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2006-11-01; Completion date: 2009-05-01
Enrollment: 133 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be included in about 15 centers in Germany and randomized to one of the above treatment regimens in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a standard length of 21 days. Primary objective will be the Progression Free Survival Time of patients as assessed in both treatment arms.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pemetrexed intervention 2: Cisplatin intervention 3: Carboplatin
Intervention descriptions: intervention 1: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles intervention 2: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles intervention 3: Area under the concentration curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

Protocol documents:
Clinical trial NCT00409175
Conditions: Familial Amyloid Polyneuropathy
Keywords: FAP Fx-1006A transthyretin TTR amyloid polyneuropathy V30M familial hereditary amyloidosis FoldRx
Sponsor: Pfizer
Start date: 2007-01-01; Completion date: 2009-05-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine whether Fx-1006A is effective in halting the progression of Familial Amyloid Polyneuropathy (FAP).

Deposition of TTR amyloid is associated with a variety of human diseases. Deposition of amyloid fibrils of variant TTR (primarily V30M) in peripheral nerve tissue produces the condition called FAP.

The prevention of the formation of amyloid by stabilization of the TTR native state should constitute an effective therapy for amyloid diseases. Therapeutic intervention with a TTR stabilizer drug, such as Fx-1006A, is hypothesized to stop progression of the disease in FAP patients. FAP is a uniformly fatal disease and Fx-1006A is intended to halt the relentless neurological deterioration FAP patients experience.

This Phase 2/3 study will enroll early to mid-stage FAP patients in order to interrupt and stabilize the disease at a point in time where progression of motor and autonomic dysfunction can be maximally effected. Male and female patients with FAP with documented V30M TTR mutation will receive Fx-1006A or placebo once daily for a period of eighteen (18) months.

Detailed description:
Deposition of TTR amyloid is associated with a variety of human diseases. Deposition of amyloid fibrils of variant TTR (primarily V30M) in peripheral nerve tissue produces the condition called FAP.

The prevention of the formation of amyloid by stabilization of the TTR native state should constitute an effective therapy for amyloid diseases. Therapeutic intervention with a TTR stabilizer drug, such as Fx-1006A, is hypothesized to stop progression of the disease in FAP patients. FAP is a uniformly fatal disease and Fx-1006A is intended to halt the relentless neurological deterioration FAP patients experience.

This Phase 2/3 study will enroll early to mid-stage FAP patients in order to interrupt and stabilize the disease at a point in time where progression of motor and autonomic dysfunction can be maximally effected. Male and female patients with FAP with documented V30M TTR mutation will receive Fx-1006A or placebo once daily for a period of eighteen (18) months.

Arms: arm 1: Fx-1006A arm 2: Placebo
Interventions: intervention 1: Fx-1006A intervention 2: Placebo
Intervention descriptions: intervention 1: Fx-1006A 20mg or matched placebo once daily (at the same time each day) for a period of 18 Months intervention 2: Fx-1006A 20mg or matched placebo once daily (at the same time each day) for a period of 18 Months

Protocol documents:
Clinical trial NCT00409292
Conditions: Pancreatic Cancer
Keywords: RAD001 metastatic pancreatic cancer
Sponsor: Dana-Farber Cancer Institute
Start date: 2007-01-01; Completion date: 2009-05-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to investigate if RAD001 is an effective treatment for pancreatic cancer that has spread and not responded to treatment. Experiments have shown that RAD001 can prevent cells from multiplying. RAD002 has also been tested in laboratory experiments imitating cancer conditions and the results have been promising.

Detailed description:
* Participants taking part in this research study will be given a study medication-dosing calendar for each treatment cycle. Each cycle lasts four weeks during which you will be taking the study drug, RAD001, orally every day.
* Participants will come into the clinic every other week during the time of enrollment. At each clinic visit blood work will be taken to monitor the participants health and a physical exam will be performed. CT scans will be repeated every 2 months to assess the tumor.
* Participants will remain on the study as long as they continue to benefit from the study medication.

Arms: arm 1: RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.

Four weeks of study drug was considered to be one cycle of treatment.
Interventions: intervention 1: RAD001
Intervention descriptions: intervention 1: Taken orally daily for as long as the participant continues to receive a benefit.

Protocol documents:
Clinical trial NCT00420238
Conditions: Ankylosing Spondylitis
Keywords: Axial Ankylosing Spondylitis Adult
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2007-01-01; Completion date: 2009-05-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Etanercept (Enbrel) intervention 2: Placebo
Intervention descriptions: intervention 1: 50 mg injection once weekly intervention 2: placebo

Protocol documents: