ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00571974
Conditions: Leukoplakia Erythroplakia
Sponsor: University of Arkansas
Start date: 2007-01-01; Completion date: 2012-01-01
Enrollment: 29 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Oral leukoplakia within the mouth is a visible white patch which can develop into cancer if not treated. There is no good treatment for these lesions, apart from surgery which is associated with significant side effects and physical deformation of the treated area.

The investigators hypothesized that photodynamic therapy can be used safely and effectively to induce significant regression of oral leukoplakia.

Detailed description:
This is a combined Phase I/II non-randomized prospective study designed to determine the safety and assess the clinical efficacy of PDT in the treatment of oral leukeplekia with 5-ALA and 585-nm PDL with 1.5 ms pulse time. In the first part of the study we determined the maximum tolerated dose (MTD) of the PDL radiant exposure in combination with 5-ALA. In the second phase of the study, this dose is used to treat subjects at the MTD in order to determine the efficacy of the treatment by documenting the regression of the treated lesions.

Arms: arm 1: During Phase I, to determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.

The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD). Procedure: Fluorescence Diagnosis Imaging Interventions: Application of 5-ALA to lesion followed by activation with high power 585 nm pulsed dye laser (PDL-585, ScleroPLUS laser) at 6, 7 and 8 J/cm2. arm 2: Procedure: Fluorescence Diagnosis Imaging

Interventions: Application of 5-ALA to lesion followed by activation with high power 585 nm pulsed dye laser (PDL-585, ScleroPLUS laser) at 8 J/cm2.
Interventions: intervention 1: PDL-585, ScleroPLUS laser intervention 2: 5-Aminolevulinic Acid (Levulan KerastickTM) intervention 3: Fluorescence Diagnosis Imaging
Intervention descriptions: intervention 1: PDT Treatment; emits light with 585 nm wavelength in pulses of 1.5 milliseconds in sections of 5 mm diameter to target the lesion and surrounding tissue intervention 2: Topically administered; incubation time 60-180 minutes; single dose (345 mg of active 5-ALA in 1.5 ml solution); soaked onto white gauze and applied to lesion, covered with sterile Xeroform gauze intervention 3: FD Image taken prior to PDL-585 usage

Protocol documents:
Clinical trial NCT00598806
Conditions: Bladder Cancer
Keywords: Noninvasive Bladder Cancer
Sponsor: Spectrum Pharmaceuticals, Inc
Start date: 2007-08-01; Completion date: 2012-01-01
Enrollment: 812 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.

Detailed description:
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study. Within 14 days of Screening, eligible patients underwent a TURBT during Visit 1 (Day 0) following which they were immediately randomized in a 1:1 ratio to receive either placebo or 4 mg apaziquone, instilled in a volume of 40 mL into the bladder within 6 hours from the end of the TURBT procedure. After a 60-minute retention period, study drug was drained from the bladder.

A postoperative follow-up examination and review of the local pathology report were performed at Visit 2, which occurred 21 days (±10 days) after the TURBT (Week 3).

* If the histology of the patient's tumor was confirmed as Ta, G1-G2 (ie, low grade according to World Health Organization \[WHO\]/International Society of Urologic Pathology \[ISUP\] classification), no further treatment was given and the patient was observed cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10).
* If the histology of the patient's tumor was other than Ta, G1 or G2 (low grade \[WHO/ISUP classification\]), further treatment was given in accordance with current treatment guidelines, and the patient was followed up cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10).

All patients were to be followed for 2 years.

Arms: arm 1: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT arm 2: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Interventions: intervention 1: Apaziquone intervention 2: Placebo intervention 3: TURBT
Intervention descriptions: intervention 1: A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT intervention 2: A single intravesical dose of placebo instilled into the bladder post-TURBT intervention 3: TransUrethral Resection of the Bladder Tumor

Protocol documents:
Clinical trial NCT00610714
Conditions: Ovarian Neoplasms Ovarian Cancer
Keywords: Cancer Tumour Ovarian Neoplasms Ovarian Cancer
Sponsor: AstraZeneca
Start date: 2008-04-01; Completion date: 2012-01-01
Enrollment: 211 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer

Detailed description:

Arms: arm 1: carboplatin plus paclitaxel arm 2: AZD0530 in combination with carboplatin plus paclitaxel
Interventions: intervention 1: AZD0530 intervention 2: Carboplatin intervention 3: Paclitaxel
Intervention descriptions: intervention 1: oral once daily dose intervention 2: intravenous injection intervention 3: intravenous infusion

Protocol documents:
Clinical trial NCT00635089
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic Esophagitis Cinquil
Sponsor: Ception Therapeutics
Start date: 2008-07-01; Completion date: 2012-01-01
Enrollment: 190 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is an open-label study where all subjects will receive active drug, reslizumab. Subjects are able to enter this trial only through completion of study Res-05-0002 (NCT00538434).

The goal of the study is to show longer term safety and efficacy in pediatric subjects who have eosinophilic esophagitis.

Detailed description:
Subjects will enter this open-label extension study after completing the placebo-controlled, double-blind study Res-5-0002 (NCT00538434). The end of study visit for Res-05-0002 will serve as the screening visit for this trial.

All subjects will receive reslizumab and be followed by their principal investigators in an unblinded fashion. Visits and administration of reslizumab will be monthly.

Arms: arm 1: Open-label reslizumab intravenous (IV) infusion at an initial dose of 1 mg/kg monthly
Interventions: intervention 1: reslizumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00654147
Conditions: HIV Infections
Keywords: HIV antiretroviral therapy naive Integrase inhibitor HIV/AIDS treatment naïve
Sponsor: Margaret A. Fischl, M.D.
Start date: 2008-04-01; Completion date: 2012-01-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A prospective, randomized, open-label pilot study to assess virologic suppression and immunologic recovery associated with a two-drug antiretroviral regimen of Raltegravir and the protease inhibitor lopinavir/ritonavir (LPV/r) and a three drug regimen with Raltegravir and two nRTIs (emtricitabine/tenofovir) in HIV-1 infected treatment-naïve subjects.

Immunology Substudy added to determine the kinetics of recovery of CD4 T cells and subpopulations (regulatory T cell \[T regs\], TH-17 and TH1) after treatment initiation with Raltegravir based regimens and their relationship with functional CD8 T cells and if Raltegravir containing therapies leads to decreases in markers of gut microbial translocation and of cellular and soluble markers of immune activation.

Detailed description:
A009 is a prospective, randomized, open-label pilot study to assess virologic suppression and immune recovery rates associated with a two-drug potent antiretroviral regimen of raltegravir and the protease inhibitor lopinavir/ritonavir and a three-drug regimen with raltegravir and two nRTIs (emtricitabine/tenofovir) in treatment-naïve subjects.

HIV-1-infected subjects who are antiretroviral drug-naïve and have plasma HIV-1 RNA levels ≥5000 copies/ml obtained within 30 days prior to study entry will be randomized 1:1 to Raltegravir 400 mg BID + LPV 400 mg/RTV 100 mg BID (Arm A) or Raltegravir 400 mg BID + FTC 200 mg/TDF 300 mg QD (Arm B).

Subjects will have measurements of HIV-1 RNA and CD4+ and CD8+ T-cell counts at pre-entry and entry. The average of these measurements will be used to establish their baseline values. Following entry, subjects will have plasma HIV-1 RNA samples drawn at days 2, 4, 8 and at weeks 2, 4, 8, 16, 24, 32, 40 and 48 and at virologic failure. CD38 expression on CD4+/CD8+ cells and CD38/HLA-DR activation antigen on CD4+ and CD8+ cells and subsets T-cell percentage will be done at entry, day 8 and weeks 4, 8, 24 and at virologic failure by advanced flow cytometry.

Arms: arm 1: Raltegravir 400 mg tablet and Lopinavir/ritonavir capsule by mouth, every 12 hours for 48 weeks arm 2: Raltegravir 400 mg tablet bu mouth, every 12 hours for 48 weeks and tenofovir/embritcitabine 200 mg/100 mg table by mouth, once daily for 48 weeks
Interventions: intervention 1: Raltegravir & Lopinavir/ritonavir intervention 2: Raltegravir and emtricitabine/tenofovir
Intervention descriptions: intervention 1: Two drug regimen of an integrase inhibitor and ritonavir boosted protease inhibitor intervention 2: Three drug regimen of an integrase inhibitor and a fixed dose combination of a non-nucleoside/nucleotide inhibitors

Protocol documents:
Clinical trial NCT00657358
Conditions: Pain
Keywords: lidocaine allodynia chronic regional pain syndrome pain
Sponsor: University of Alabama at Birmingham
Start date: 2008-04-01; Completion date: 2012-01-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to study if lidocaine, given intravenously, reduces pain.

Detailed description:
Clinicians use lidocaine intravenously in a fashion that suggests that it might have analgesic effects. Therefore, we test the hypothesis that lidocaine reduces pain intensity in response to experimental pain.

Arms: arm 1: Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
Interventions: intervention 1: Lidocaine
Intervention descriptions: intervention 1: Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.

Protocol documents:
Clinical trial NCT00663702
Conditions: Arthritis, Rheumatoid
Sponsor: Bristol-Myers Squibb
Start date: 2008-05-01; Completion date: 2012-01-01
Enrollment: 123 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether switching to subcutaneous administration of abatacept will be safe in participants with rheumatoid arthritis who previously received long-term therapy with intravenous abatacept

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Abatacept
Intervention descriptions: intervention 1: Subcutaneous injection, 125 mg/mL, once weekly, 48 months

Protocol documents:
Clinical trial NCT00667095
Conditions: Overactive Bladder Urinary Urge Incontinence Urinary Incontinence Detrusor Hyperreflexia Urge Incontinence
Keywords: OAB Over Active Bladder overactive bladder Urinary Urge Incontinence Urinary Incontinence Botox DMSO bladder instillation instillation detrusor hyperreflexia urge incontinence
Sponsor: Mayo Clinic
Start date: 2008-04-01; Completion date: 2012-01-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether women with overactive bladder (OAB) who receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms when compared to a similar group of women with OAB who receive instillation of DMSO only.

Detailed description:
The primary objective of this study is to evaluate the efficacy of catheter-based instillation of a solution of Botox/DMSO as a novel method for treating women with overactive bladder (OAB) and secondary urinary incontinence who have failed oral pharmacologic therapy. This study will test the broad hypothesis that administration of Botox/DMSO instillations into the bladder with a urethral catheter can significantly improve symptoms and quality of life in patients with OAB when compared to DMSO installations alone. Explicitly, we hypothesize that scores on the validated Incontinence Quality of Life (I-QOL) questionnaire of women with OAB who receive Botox/DMSO instillation will be much improved at three-month follow-up compared to similar women receiving DMSO instillation alone. Our long-term goal is to offer women with detrusor hyperreflexia or OAB a less invasive alternative to surgery and an alternative to anticholinergic by mouth medications. In support of this effort, we are proposing a randomized, double-blind, placebo controlled clinical trial to be conducted in the Department of Urology at Mayo Clinic, Jacksonville, Florida.

Note: The study was terminated early in July of 2011 due to an extended medical absence of the Principal Investigator.

Arms: arm 1: Botulinum-A Toxin (Botox) 300 units in 50 cubic centimeters of Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution arm 2: Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters
Interventions: intervention 1: Botox Instillation intervention 2: DMSO Instillation
Intervention descriptions: intervention 1: Botox instilled into the bladder via ureteral catheter and retained for up to 30 minutes then spontaneously voided. intervention 2: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.

Protocol documents:
Clinical trial NCT00701935
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus Amylin Lilly
Sponsor: AstraZeneca
Start date: 2008-08-01; Completion date: 2012-01-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multicenter, randomized, double-blind, placebo-controlled trial will assess the effects of twice-daily subcutaneous injection with exenatide versus treatment with matching placebo injection on abdominal visceral fat content.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: placebo intervention 2: exenatide
Intervention descriptions: intervention 1: subcutaneous injection, twice a day intervention 2: subcutaneous injection, twice a day, 10mcg

Protocol documents:
Clinical trial NCT00708201
Conditions: Postoperative Ileus
Keywords: ileus POI
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2009-03-01; Completion date: 2012-01-01
Enrollment: 280 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objectives of the study are:

* to evaluate the effect of alvimopan on hospital length of stay
* to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related morbidities
* to evaluate the overall and cardiovascular safety of alvimopan

Detailed description:

Arms: arm 1: 12 milligrams (mg)

Alvimopan, 12mg, capsule. Administered orally. One 30 minutes to 5 hours before the scheduled start of surgery on Day 0, and twice daily beginning on Postoperative Day 1 (POD 1) until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment arm 2: 300 mg polyethylene glycol in a capsule

Administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Interventions: intervention 1: Alvimopan intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00708942
Conditions: Cervical Intraepithelial Neoplasia
Keywords: Cervical intraepithelial neoplasia (CIN)
Sponsor: Photocure
Start date: 2009-01-01; Completion date: 2012-01-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.

Detailed description:
Low-grade cervical intraepithelial neoplasia (CIN1) is caused by persistent HPV infection and may worse case develop into cancer. In most cases both the virus infection and lesions (CIN1) regress spontaneously, but must be followed up with gynecological examinations to ensure normalization. If further persistent disease and worsening to precancerous lesions (CIN2-3), the usual treatment is surgery, where one removes the tissue in the cervix where the CIN lesions are.

In this research study we will evaluate a new non-surgical treatment for CIN1 using hexaminolevulinate (HAL) photodynamic therapy (PDT). HAL PDT is the combination of a medication and a specific type of light to activate the drug. HAL PDT selectively removes CIN lesions while preserving normal tissue, thus this may be an alternative to frequent gynecological consultations and local surgery that may have undesirable side effects.

Arms: arm 1: HAL suppository (single administration, HAL 100mg), laser illumination (50J/cm2) arm 2: Placebo suppository (single administration), laser illumination (50J/cm2) arm 3: None arm 4: HAL ointment (5%, 100mg, single administration), LED diode illumination (50J/cm2) arm 5: Placebo ointment (single administration), no illumination
Interventions: intervention 1: Hexaminolevulinate (HAL) intervention 2: Placebo intervention 3: Hexaminolevulinate (HAL) intervention 4: Placebo
Intervention descriptions: intervention 1: Drug: hexaminolevulinate (HAL) Suppository HAL 100 mg for 3-7 hours application intervention 2: Placebo suppository, for 3-7 hours application intervention 3: Drug: hexaminolevulinate (HAL) Ointment HAL 100 mg for 5 hours application intervention 4: Placebo ointment for 5 hours application

Protocol documents:
Clinical trial NCT00726037
Conditions: Metastatic Pancreatic Cancer
Keywords: Denileukin diftitox Metastatic Pancreatic Cancer Ontak Regulatory T-cell
Sponsor: Loyola University
Start date: 2008-10-01; Completion date: 2012-01-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to determine the duration of T reg suppression in patients with metastatic pancreatic cancer receiving Ontak. The goal is to define the optimal time for future dendritic cell vaccine administration.

Detailed description:
Despite improved insight into the epidemiology and biology, pancreatic cancer remains a significant health problem as evidenced by the disappointing survival rates associated with advanced disease. Because of its aggressive growth and early metastatic dissemination, only 20% of patients can be treated by surgery at the time of diagnosis. Furthermore, the overall 5-year survival rate of stage IV disease is \< 5% \[1-3\] despite chemotherapy. With such a dismal outlook, it is obvious that novel treatment strategies are required.

There is limited experience in the literature with the use of Ontak in the treatment of metastatic pancreatic cancer. Viehl, et al, demonstrated in a murine model of pancreatic cancer, that ontak combined with whole tumor vaccine led to a significantly increased T cell-dependent antitumor immune response, as well as an improved survival compared to controls. Our group has an active trial at Loyola evaluating the role of dendritic cell vaccine in patients with unresectable, not metastatic, pancreatic cancer. Preliminary data suggests a correlation with time to progression and restoration of Tregs following an initial decrease after the DC injection. The goal of the current proposal is to determine the time point at which the Tregs reach the nadir within four weeks of ontak injection. When this is determined, we will eventually propose administering ontak followed by DC vaccine at the nadir Treg time point for patients with unresectable pancreatic cancer

Arms: arm 1: Three doses of Ontak 9 mcg/Kg IV over 30 minutes every other day for 1 week
Interventions: intervention 1: Ontak
Intervention descriptions: intervention 1: One dose of Ontak 9 mcg/Kg IV over 30 minutes times 3 doses. 1 dose every other day

Protocol documents:
Clinical trial NCT00730925
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2008-06-01; Completion date: 2012-01-01
Enrollment: 41 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the RECIST criteria, in patients with advanced NSCLC Stage IIIB or IV whose tumours harbour activating mutations within exon 18 to exon 21 of the EGFR receptor, in patients with mutations in the HER2/neu receptor and in patients with EGFR FISH positive tumours with no EGFR mutations.

Detailed description:

Arms: arm 1: patient to receive tablets of BIBW 2992 once a day, starting at high dose until progression of the disease arm 2: patient whose disease progressed on treatment with BIBW 2992 monotherapy to receive tablet of BIBW 2992 once a day in combination with i.v. paclitaxel 3 weekly
Interventions: intervention 1: BIBW2992 intervention 2: BIBW2992 + paclitaxel
Intervention descriptions: intervention 1: tablet BIBW high dose intervention 2: tablet BIBW 2992 in combination with i.v. paclitaxel 3 weekly

Protocol documents: