ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01719861
Conditions: Small Cell Lung Cancer (SCLC) Neuroendocrine Tumors
Sponsor: Joel Neal
Start date: 2012-10-01; Completion date: 2015-05-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Intrapatient dose escalation study of desipramine in subjects with small cell lung cancer (SCLC) and other high-grade neuroendocrine tumors.

Detailed description:
Participants will start desipramine by mouth nightly (QHS) for 6 weeks, with weekly dose escalation. Starting dose will be 25 to 75 mg. The desipramine dose will be escalated until the maximum dose of 450 mg is reached or a maximum safe dose per subject is established.

Dose level may be adjusted (decreased) based on cardiac or general adverse effects. desipramine level will be tapered if the subject experience disease progression, unless physician judges immediate suspension is in the subjects best interest.

Assessments will be conducted every 28 days, and will include ECGs, physicians and blood samples.

One partial and/or complete response will be sufficient to consider a larger clinical trial.

Arms: arm 1: Desipramine is a tricyclic antidepressant (TCA).
Interventions: intervention 1: Desipramine HCL
Intervention descriptions: intervention 1: Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. The target dose level at 6 weeks is 450 mg (maximum dosage) or the maximum tolerated dose (MTD) for each subject.

Protocol documents:
Clinical trial NCT01732549
Conditions: Metastatic Castrate Resistant Prostate Cancer
Sponsor: Ipsen
Start date: 2013-01-01; Completion date: 2015-05-01
Enrollment: 144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to confirm that tasquinimod used as maintenance therapy is active and tolerable in patients with metastatic castrate-resistant prostate cancer not progressing after a first chemotherapy with docetaxel.

Detailed description:

Arms: arm 1: 1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg or 1 mg per day) until disease progression or toxicity or patient's willingness to stop. arm 2: 1 capsule daily, taken orally with water and food until disease progression or toxicity or patient's willingness to stop.
Interventions: intervention 1: Tasquinimod intervention 2: Placebo
Intervention descriptions: intervention 1: A patient's dose will escalate from one level to the next, once tolerability of the current dose is established. If tolerability issues arise at 0.5 or 1 mg/day, patients will have their dose reduced to 0.25 or 0.5 mg/day, respectively. intervention 2: Placebo capsules are identical to tasquinimod capsules in appearance and excipients but exclude the active compound (tasquinimod), to be taken orally once a day with water and food

Protocol documents:
Clinical trial NCT01735630
Conditions: Alzheimer's Disease
Keywords: Agitation Aggression patients
Sponsor: OPKO Health, Inc.
Start date: 2012-11-01; Completion date: 2015-05-01
Enrollment: 350 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine whether ELND005 is effective in treating symptoms of agitation and aggression in patients with Alzheimer's disease

Detailed description:

Arms: arm 1: ELND005 film coated tablets, BID for 12 weeks arm 2: Matched placebo BID for 12 weeks
Interventions: intervention 1: ELND005 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01738438
Conditions: Breast Cancer
Keywords: Metastatic Triple Negative Stage IV
Sponsor: Dana-Farber Cancer Institute
Start date: 2013-02-01; Completion date: 2015-05-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this research study, we are looking at the anti-tumor effects of Cabozantinib (XL184) in metastatic breast cancer. Data suggest that MET expression and activation are important for initiation and progression of triple-negative breast cancer (TNBC). We evaluated the efficacy of cabozantinib (XL184), a novel inhibitor of multiple receptor tyrosine kinases, including MET and VEGFR2, in patients with metastatic TNBC.

Detailed description:
OBJECTIVES:

Primary

\* To evaluate the activity of cabozantinib, as defined by objective response rate in patients with triple-negative metastatic breast cancer

Secondary

* To evaluate progression free survival
* To evaluate c-Met and phospho c-Met expression in archival tumor tissue
* To evaluate the incidence of c-Met amplified circulating tumor cells at baseline
* To evaluate potential plasma biomarkers of cabozantinib

DESIGN:

This study uses a two-stage design enrolling 35 patients to evaluate efficacy of cabozantinib based on overall response defined as complete or partial response per RECIST1.1 criteria. The null and alternative overall response rates were 5% and 20%. If one or more patients enrolled in the stage one cohort (n=13 patients) achieve PR or better then accrual proceeds to stage two (n=22 patients).

Arms: arm 1: Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Cabozantinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01749930
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Intraocular pressure
Sponsor: Bausch & Lomb Incorporated
Start date: 2013-01-01; Completion date: 2015-05-01
Enrollment: 420 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT), the primary objective is to demonstrate that the mean IOP reduction after 3 months of treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will be conducted at the end of Visit 6 (3 months) where all participants will receive BOL-303259-X QD for an additional 3 months.

Detailed description:

Arms: arm 1: BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s). arm 2: Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).
Interventions: intervention 1: BOL-303259-X intervention 2: Timolol intervention 3: BOL-303259-X
Intervention descriptions: intervention 1: BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning intervention 2: Timolol will be administered BID once in the morning and once in the evening. intervention 3: All participants will receive a topical ocular BOL-303259-X QD in the evening from 3 months (Visit 6) through 6 months (Visit7).

Protocol documents:
Clinical trial NCT01750684
Conditions: Acute Spinal Cord Injury
Keywords: Acute Traumatic SCI Spinal Cord Injury
Sponsor: Acorda Therapeutics
Start date: 2013-07-01; Completion date: 2015-05-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The principal aim of this study was to establish the feasibility of rapid administration, safety, and tolerability of AC105 in patients with acute spinal cord injury.

Detailed description:
To determine safety and tolerability of AC105 following a regimen of 6 intravenous doses over 30 hours in patients with acute non-penetrating traumatic spinal cord injury (SCI).

Arms: arm 1: Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals. arm 2: Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.
Interventions: intervention 1: AC105 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01755169
Conditions: Chronic Pain
Keywords: Chronic pain Child Pediatric Ketamine
Sponsor: Medical University of South Carolina
Start date: 2013-01-01; Completion date: 2015-05-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to select the most tolerable dose of oral ketamine for children with chronic pain. Children will be given either placebo or one of three dosages of oral ketamine for 2 weeks. The dosage that is most tolerable will be selected for further study.

Detailed description:
Children with chronic pain are randomized to one of four arms (three study drug arms, one placebo arm) in a randomized, double-blinded fashion. Children are treated for 2 weeks and then monitored for an additional 12 weeks. Study participation is a total of 14 weeks.

Arms: arm 1: A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks. arm 2: A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks. arm 3: A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks. arm 4: None
Interventions: intervention 1: Ketamine intervention 2: Placebo
Intervention descriptions: intervention 1: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant). intervention 2: None

Protocol documents:
Clinical trial NCT01772316
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2012-12-01; Completion date: 2015-05-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multicenter, open-label, single arm, long-term extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in participants with moderate to severe rheumatoid arthritis who have completed the 97-week WA22762 or the 96-week NA25220 core study. Participants will receive RoActemra/Actemra 162 milligram (mg) subcutaneously weekly (for participants entering from WA22762) or every two weeks (for participants entering from NA25220) for 96 weeks, with telephone call follow-up visits at Weeks 100 and 104.

Detailed description:

Arms: arm 1: Participants received Tocilizumab 162 milligram (mg) given as 0.9 milliliter (mL) of a 180 milligram per milliliter (mg/mL) solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
Interventions: intervention 1: tocilizumab
Intervention descriptions: intervention 1: 162 mg subcutaneously weekly or every two weeks, 96 weeks

Protocol documents:
Clinical trial NCT01777191
Conditions: Plaque Psoriasis
Sponsor: Eli Lilly and Company
Start date: 2013-03-01; Completion date: 2015-05-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.

Detailed description:

Arms: arm 1: Ixekizumab administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection every 2 weeks (Q2W) at week 2, 4, 6, 8 and 10. Starting from Week 12, 80 mg Ixekizumab Prefilled Syringe was administered by one 80 mg SC injection every 4 weeks (Q4W). arm 2: Ixekizumab administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10. Starting from Week 12, 80 mg Ixekizumab Prefilled Syringe was administered by one 80 mg SC injection Q4W.
Interventions: intervention 1: Ixekizumab Auto-Injector intervention 2: Ixekizumab Prefilled Syringe
Intervention descriptions: intervention 1: Administered SC by auto-injector intervention 2: Administered SC by prefilled syringe

Protocol documents:
Clinical trial NCT01777412
Conditions: Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder
Keywords: NMO NMOSD NMO-IgG Aquaporin-4 AQP4 anti-AQP4
Sponsor: Johns Hopkins University
Start date: 2013-06-01; Completion date: 2015-05-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase 1b interventional trial of bevacizumab (Avastin®) to evaluate the tolerability/safety and preliminary efficacy of bevacizumab (Avastin®) as add-on therapy for treatment of acute optic neuritis and/or transverse myelitis in neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD). A single infusion of Avastin® is added to standard-of-care high dose steroids and an additional dose of Avastin® is added to plasma exchange (if necessary). The primary outcomes are clinical changes in the Expanded Disability Severity Scale, Timed 25-foot Walk and Low Contrast Visual Acuity, MRI parameters and safety.

Detailed description:
Study Objective: The overall objective is to evaluate the tolerability/safety and efficacy of adding bevacizumab (Avastin®) to standard of care therapy in improving clinical and radiologic outcomes of acute optic neuritis and/or transverse myelitis in neuromyelitis optica and neuromyelitis optica spectrum disorders.

Primary Objective: To compare the clinical and radiographic outcome following acute optic neuritis and/or transverse myelitis in NMO/NMOSD in patients who receive 1-2 doses of 10 mg/kg dose of bevacizumab (Avastin®) in addition to standard medical therapy.

Secondary Objectives:

* To determine the effect of Avastin on NMO clinical scores (Expanded Disability Status Scale, Timed 25-foot Walk and Low Contrast Visual Acuity \[LCVA\]).
* To evaluate the safety and tolerability of a 10 mg/kg dose of intravenous Avastin.
* To determine the frequency of adverse events with Avastin in this patient population.
* To determine the effect of Avastin on MRI lesion size and extent.

The duration of the investigation is 1-2 years.

Arms: arm 1: Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase.
Interventions: intervention 1: Bevacizumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01786174
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS Gilenya Fingolimod
Sponsor: Massachusetts General Hospital
Start date: 2013-08-01; Completion date: 2015-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Gilenya, also known as fingolimod, is safe and tolerable in patients with Amyotrophic Lateral Sclerosis (ALS).

Detailed description:
The primary objective of the study is to determine the acute safety and tolerability of oral administration of Gilenya (fingolimod) 0.5mg daily vs. matched oral placebo administered daily.

The primary outcome measure will be safety and tolerability; safety will be assessed by the occurrence of adverse events and clinically meaningful changes in vital signs, ophthalmologic examination, physical examination, electrocardiogram and standard clinical laboratory blood tests, and tolerability will be defined as the ability of subjects to complete the entire 4-week study.

The secondary outcome measure will be the measured effect of the treatment on circulating lymphocyte populations in patients with ALS.

Exploratory outcome measures will include the rate of decline of the ALS Functional Rating Scale (Revised) (ALSFRS-R) and Slow Vital Capacity (VC) during the course of treatment.

This study will be conducted in subjects who meet the El Escorial criteria of possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS. At screening, eligible subjects must be at least 18 years old, must have an SVC ≥ 65% of predicted capacity for age, height and gender, and must provide written informed consent prior to screening. Subjects on a stable dose of riluzole and those not taking riluzole, and women of child-bearing age at screening are eligible for inclusion as long as they meet specific protocol requirements.

Subjects will remain on randomized, placebo-controlled, double-blind treatment until the Week 4 visit. Each randomized subject will also have a Week 8 Follow-up Telephone Interview to assess for adverse events (AEs), changes in concomitant medications and to administer the ALSFRS-R.

Arms: arm 1: 0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days arm 2: 0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days
Interventions: intervention 1: Gilenya intervention 2: Placebo
Intervention descriptions: intervention 1: 0.5mg Gilenya orally by mouth once daily for approximately 28 days intervention 2: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days

Protocol documents:
Clinical trial NCT01800838
Conditions: Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Stage I Cutaneous T-cell Non-Hodgkin Lymphoma Stage IA Mycosis Fungoides/Sezary Syndrome Stage IB Mycosis Fungoides/Sezary Syndrome Stage II Cutaneous T-cell Non-Hodgkin Lymphoma Stage IIA Mycosis Fungoides/Sezary Syndrome
Sponsor: Kevin Cooper MD
Start date: 2013-04-01; Completion date: 2015-05-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I trial studies the side effects and best dose of silicon phthalocyanine 4 and photodynamic therapy in treating patients with stage IA-IIA cutaneous T-cell non-Hodgkin lymphoma. Photodynamic therapy (PDT) uses a drug, silicon phthalocyanine 4, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against cutaneous T-cell non-Hodgkin lymphoma.

Funding Source - FDA OOPD

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the safety and maximum tolerated dose (MTD) that can be utilized for a single treatment of Pc 4-PDT (silicon phthalocyanine 4 photo dynamic therapy) on subjects with mycosis fungoides (MF)/cutaneous T-cell lymphoma (CTCL) stage IA-IIA, by evaluating an accelerated dose escalation protocol consisting of a single exposure to PDT using topically-applied Pc 4 and visible light at a wavelength of 675 nm, followed by assessment of skin biopsies to analyze cellular and molecular changes induced by Pc 4-PDT. (Cohort I)

II. Determine safety and tolerability of repeated light (PDT) exposures after a single application of Pc 4 to a MF/CTCL plaque, using topically-applied Pc 4 and visible light at a wavelength of 675nm, followed by assessment of skin biopsies to analyze cellular and molecular changes induced by Pc 4-PDT. (Cohort II)

III. Identification of targets for assessment of efficacy to assist in planning for a Phase II study.

OUTLINE: This is a dose-escalation study.

Patients receive silicon phthalocyanine 4 topically and then undergo PDT.

After completion of study treatment, patients are followed up at 24 hours, 1 week, 2 weeks, and 30 days.

Arms: arm 1: Patients receive silicon phthalocyanine 4 topically and then undergo PDT.
Interventions: intervention 1: silicon phthalocyanine 4 intervention 2: photodynamic therapy intervention 3: pharmacological study intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given topically intervention 2: Undergo PDT intervention 3: Correlative studies intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT01801358
Conditions: Uveal Melanoma
Keywords: Melanoma, melanoma of the eye, uveal, MEK162, AEB071
Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer
Start date: 2013-08-01; Completion date: 2015-05-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 55 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed

Detailed description:
Due to halted enrollment, the Phase II part of the study was not conducted. The Sponsor decided to permanently stop recruitment for the study prior to MTD determination.

Remaining patients on treatment with binimetinib and sotrastaurin who were considered by the Investigator to be benefiting from their treatment could have continued treatment and were to be followed up as per protocol. No patients were ongoing as of the data cut-off date. After the last patient last visit (LPLV) was declared, the study was terminated.

Arms: arm 1: AEB071 and MEK162 combined arm 2: MEK162 alone
Interventions: intervention 1: AEB071 intervention 2: MEK162
Intervention descriptions: intervention 1: Twice-daily doses of AEB071 for a cycle of 28-days, given without interruption (continuous cycles) intervention 2: Twice-daily doses of MEK162 for a cycle of 28-days, given without interruption (continuous cycles)

Protocol documents:
Clinical trial NCT01818531
Conditions: Postoperative Analgesia Medial Unicompartmental Knee Arthroplasty
Keywords: Partial knee replacement
Sponsor: Wake Forest University Health Sciences
Start date: 2013-04-01; Completion date: 2015-05-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the affects of a single injection ultrasound-guided adductor canal block for patients undergoing robotic-assisted (MAKOplasty) medial UKA (unicompartmental knee arthroplasty). Specifically, this study will compare the adequacy of postoperative analgesia provided by the adductor canal block with that provided by single injection lumbar plexus blockade. The working hypothesis is that the analgesia provided by the adductor canal block will be equivalent to the analgesia provided by the lumbar plexus block. The primary outcome will be a comparison of verbal numerical pain scores at rest and with movement over the first 24 hours following nerve blockade.

Detailed description:

Arms: arm 1: Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty. arm 2: Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.
Interventions: intervention 1: Adductor canal block intervention 2: Lumbar plexus block
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: