ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01393639
Conditions: Rheumatoid Arthritis
Keywords: treatment of rheumatoid arthritis treatment of RA patients on methotrexate for rheumatoid arthritis prednisone for rheumatoid arthritis
Sponsor: Pfizer
Start date: 2011-09-27; Completion date: 2014-06-09
Enrollment: 323 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and efficacy of multiple doses of PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo in the treatment of rheumatoid arthritis. All subjects will also be receiving background treatment of methotrexate for their rheumatoid arthritis. Study medication will be given for eight weeks followed by a 4 week period during which the dose of study medication will be gradually reduced. The efficacy of the study medications will be determined by assessing severity of the rheumatoid arthritis during the study and safety will be determined by adverse event reporting, laboratory tests and biomarker analysis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None
Interventions: intervention 1: PF-04171327 intervention 2: PF-04171327 intervention 3: PF-04171327 intervention 4: PF-04171327 intervention 5: prednisone intervention 6: prednisone intervention 7: placebo
Intervention descriptions: intervention 1: 1 mg tablet once daily (QD) for 8 weeks intervention 2: 5 mg tablet once daily (QD) for 8 weeks intervention 3: 10 mg tablet once daily (QD) for 8 weeks intervention 4: 15 mg tablet once daily (QD) for 8 weeks intervention 5: 5 mg capsule once daily for 8 weeks intervention 6: 10 mg capsule once daily for 8 weeks intervention 7: placebo (tablet or capsule) once daily (QD) for 8 weeks

Protocol documents:
Clinical trial NCT01943292
Conditions: Non Hematologic Cancers
Keywords: Focal Adhesion Kinase inhibitor FAK inhibitor Cancer Stem Cells CSC
Sponsor: Verastem, Inc.
Start date: 2013-09-02; Completion date: 2014-06-09
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase I, open-label, dose-escalation trial of defactinib (VS-6063), a focal adhesion kinase inhibitor, in Japanese patients with non-hematologic malignancies. The purpose of this study is to assess the safety (including the recommended phase 2 dose), the pharmacokinetics, and the anti-cancer activity of defactinib (VS-6063).

Detailed description:

Arms: arm 1: Oral defactinib (VS-6063) administered twice a day (BID) during a 21 day cycle.
Interventions: intervention 1: Defactinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02002767
Conditions: Hepatitis C Virus
Sponsor: Gilead Sciences
Start date: 2013-12-16; Completion date: 2014-06-09
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched healthy participants as a control group.

Detailed description:

Arms: arm 1: Participants with severe renal impairment will receive a single dose of velpatasvir. arm 2: Participants with normal renal function will receive a single dose of velpatasvir.
Interventions: intervention 1: Velpatasvir
Intervention descriptions: intervention 1: Velpatasvir 100 mg (2 x 50 mg tablets) administered orally

Protocol documents:
Clinical trial NCT02152670
Conditions: Cocaine Dependence
Sponsor: Yale University
Start date: 2014-05-01; Completion date: 2014-06-09
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Studies using positron emission tomography (PET) have been used with great success in demonstrating specific abnormalities in several facets of dopaminergic system function in human populations (Narendran and Martinez 2009). Among the first, most consistent, and broadly replicated of such findings in drug- (including cocaine) dependent individuals has been the reduction in subcortical (striatal) D2/3 receptors as imaged, most commonly, by the reversible, non-selective, D2/3 receptor antagonist radiotracer, \[11C\]raclopride. Certain dissociations on D2/3 availability by radioligand (\[11C\]raclopride vs. \[11C\]PHNO) and by brain region (striatum vs. SN; terminal vs. somatodendritic, respectively) are poorly understood in relationship to prior antagonist tracer results. In the current study the investigators will use pharmacological interventions (AMPT and methylphenidate) with both antagonist and agonist radiotracers to experimentally reconcile these discordant findings and clarify potential mechanistic inter-relationships.

Detailed description:

Arms: arm 1: Subjects will receive 2 baseline PET scans with the radioligands (11C)(+)PHNO and (11C)(+)raclopride arm 2: Subjects will receive 1 PET scan following a PO dose of 60mg of methylphenidate to facilitate dopamine release with the radioligand (11C)(+)PHNO arm 3: Subjects will receive 2 PET scans following 48 hours of dopamine depletion via AMPT with the radioligands (11C)(+)PHNO and (11C)(+)raclopride
Interventions: intervention 1: Methylphenidate intervention 2: Alpha Methyl Para Tyrosine (AMPT) intervention 3: [11C]PHNO intervention 4: [11C]raclopride
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01616654
Conditions: Acne Vulgaris
Sponsor: Galderma R&D
Start date: 2012-06-20; Completion date: 2014-06-12
Enrollment: 304 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy and safety of different concentrations of CD5789 cream in participants with acne vulgaris for the purpose of dose identification.

Detailed description:

Arms: arm 1: Participants randomized in stratum 1, 2 and 3 were applied with 25 mcg/g CD5789 cream, once daily for 12 weeks. arm 2: Participants randomized in stratum 1, 2 and 3 were applied with 50 mcg/g CD5789 50 once daily for 12 weeks. arm 3: Participants randomized in stratum 1, 2 and 3 were applied with 100 mcg/g CD5789 cream, once daily for 12 weeks. arm 4: Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks. arm 5: Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
Interventions: intervention 1: CD5789 25 µg/g cream intervention 2: CD5789 50 µg/g cream intervention 3: CD5789 100 µg/g cream intervention 4: Tazarotene 0.1% gel intervention 5: Vehicle cream
Intervention descriptions: intervention 1: CD5789 25 µg/g cream applied once daily intervention 2: CD5789 50 µg/g cream applied once daily intervention 3: CD5789 100 µg/g cream applied once daily intervention 4: Tazarotene 0.1% gel applied once daily intervention 5: Vehicle cream applied once daily

Protocol documents:
Clinical trial NCT01785849
Conditions: Hyperparathyroidism, Secondary
Keywords: Secondary Hyperparathyroidism (SHPT), chronic kidney disease (CKD), hemodialysis, parathyroid hormone (PTH), hypocalcemia, bone and mineral metabolism
Sponsor: Amgen
Start date: 2013-03-12; Completion date: 2014-06-12
Enrollment: 508 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.

Detailed description:

Arms: arm 1: Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times a week, for 26 weeks. arm 2: Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
Interventions: intervention 1: Etelcalcetide intervention 2: Placebo
Intervention descriptions: intervention 1: Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at 4-week intervals by 2.5 mg or 5 mg on the basis of the predialysis parathyroid hormone and corrected calcium concentrations obtained in the prior week. The minimum dose was 2.5 mg and the maximum dose was 15 mg. intervention 2: Administered intravenously (IV) three times per week.

Protocol documents:
Clinical trial NCT01867294
Conditions: Advanced Malignant Neoplasm Dermatologic Complication
Sponsor: Academic and Community Cancer Research United
Start date: 2012-08-31; Completion date: 2014-06-13
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with cancer that has spread to other places in the body and are receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine feasibility of the administration of topical spironolactone versus placebo in this patient population. (Study I) II. To further explore the efficacy of the topical spironolactone to prevent/attenuate rash from EGFR inhibitors. (Study II)

SECONDARY OBJECTIVES:

I. To explore efficacy of the spironolactone versus placebo. (Study I) II. To describe the efficacy of a Modified Preemptive Therapy Regimen intervention. (Study II) III. To explore the adverse event profile of spironolactone and the Modified Preemptive Therapy Regimen intervention. (Study II) IV. To explore patient reported outcomes of patients using spironolactone and a Modified Preemptive Therapy Regimen intervention. (Study II) V. To explore long term (8 week) effect of the 4 week treatment of spironolactone and a Modified Preemptive Therapy Regimen intervention on EFGR induced rash. (Study II)

OUTLINE:

STUDY I: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients apply spironolactone topically to face twice daily (BID) for 4 weeks.

ARM II: Patients apply placebo topically to face BID for 4 weeks.

STUDY II: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients apply spironolactone topically to face and body BID for 4 weeks

ARM II: Patients undergo modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically before going outside, hydrocortisone topically once daily (QD), and doxycycline orally (PO) BID for 4 weeks.

After completion of study, patients are followed up for 4 weeks.

Arms: arm 1: Patients apply spironolactone topically to face BID for 4 weeks. arm 2: Patients apply spironolactone topically to face and body BID for 4 weeks. arm 3: Patients apply placebo topically to face BID for 4 weeks. arm 4: Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.
Interventions: intervention 1: Doxycycline intervention 2: Management of Therapy Complications intervention 3: Placebo intervention 4: Questionnaire Administration intervention 5: Spironolactone intervention 6: Sunscreen intervention 7: Therapeutic Hydrocortisone
Intervention descriptions: intervention 1: Given PO intervention 2: Moisturizer given topically intervention 3: Given topically intervention 4: Ancillary studies intervention 5: Given topically intervention 6: Given topically intervention 7: Given topically

Protocol documents:
Clinical trial NCT01186406
Conditions: Glioblastoma Multiforme Gliosarcoma
Keywords: glioblastoma multiforme gliosarcoma malignant glioma glioma Gliadel carmustine wafers Avastin bevacizumab Temodar temozolomide Pro00025180 Desjardins Duke Preston Robert Tisch Brain Tumor Center
Sponsor: Duke University
Start date: 2011-04-01; Completion date: 2014-06-16
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and effectiveness of Gliadel wafers at the time of surgery, followed by the combination of radiation, Temodar, and Avastin, and then the combination of Avastin and Temodar, after radiation is complete, on malignant brain tumors.

About six weeks after surgery, subjects will begin standard radiation therapy, a fixed dose of Avastin every 2 weeks, and daily Temodar for the six and a half weeks of radiation. Beginning 2-3 weeks after the last radiation therapy, subjects will be given the same fixed dose of Avastin intravenously (through the vein) every 14 days. They will also be given a higher dose of oral Temodar to take daily the first 5 days of each 28-day study cycle.

Detailed description:

Arms: arm 1: Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation
Interventions: intervention 1: Gliadel intervention 2: Radiation Therapy intervention 3: Avastin intervention 4: Temodar
Intervention descriptions: intervention 1: Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. intervention 2: At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. intervention 3: Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively.

Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. intervention 4: At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation. In addition, beginning 2-3 weeks after the last radiation therapy, but not greater than 8 weeks, patients will be treated with 5 day Temodar (200 mg/ m2).

Protocol documents:
Clinical trial NCT01757197
Conditions: Glucocorticosteroid Refractory Acute GVHD
Sponsor: Weill Medical College of Cornell University
Start date: 2013-11-07; Completion date: 2014-06-17
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if Tocilizumab is a safe and effective treatment for steroid-refractory acute graft versus host disease.

Detailed description:
This clinical trial is testing a drug called Tocilizumab (a monoclonal antibody) as a first line therapy for subjects with steroid-refractory acute graft versus host disease (acute GVHD) after undergoing a bone marrow transplant. The purpose of the study is to test the safety and efficacy of Tocilizumab at differing dose schedules. There are 2 phases to this study. Both phases include subjects with acute GVHD have not responded to steroid treatment. Subjects enrolled in Phase IIp will receive Tocilizumab 8 mg/kg every week or every 2 weeks. Subjects enrolled in Phase II will receive one of two dose schedules determined by the results of Phase IIp. Depending on the dose they are assigned to, subjects will receive Tocilizumab every week or every 2 weeks for a total of 8 doses. The study medication may be interrupted, withheld or stopped for different reasons. However, subjects will be asked to follow up periodically for one year after starting Tocilizumab treatment.

Arms: arm 1: Toclizumab will be administered on Day 0. The administration of tocilizumab will be every 2 weeks for a total of 8 doses.
Interventions: intervention 1: Toclizumab
Intervention descriptions: intervention 1: 8 mg/kg IV, once every 1-2 weeks. The maximum dose per infusion should not exceed 800 mg.

Protocol documents:
Clinical trial NCT01484626
Conditions: Multiple Myeloma
Keywords: Relapsed Multiple Myeloma Refractory Multiple Myeloma Bendamustine Bortezomib Lenalidomide Dexamethasone Treanda Velcade Revlimid
Sponsor: Loyola University
Start date: 2011-05-05; Completion date: 2014-06-18
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine the safety and efficacy of the use of bendamustine in combination with a commonly used combination chemotherapy to treat relapsed and refractory multiple myeloma. The study will be conducted in two phases. Participants in phase I will receive 1 of 4 escalating doses of bendamustine. Once the maximum tolerated dose of bendamustine is determined, phase II of this trial will begin. Participants in phase II will receive the maximum tolerated dose of bendamustine in combination with standard of care chemotherapy.

Detailed description:
Multiple myeloma is a multi-organ neoplastic disorder caused by the clonal proliferation of plasma cells. It has an incidence of about 4.5/100,000 per year in the U.S., making it the second most common hematologic malignancy. For many years, alkylating agents have been the backbone of treatment. The combination of melphalan and prednisone was, for many years, the standard of care for patients who were not candidates for autologous transplantation. Melphalan continues to be the primary conditioning agent for autologous transplant,and cyclophosphamide has also gained a foothold in the treatment of this disease.

The introduction of novel agents has fundamentally changed the landscape of treating this disease, although the true effects on survival are not yet known. Immunomodulatory agents and proteosome inhibitors, including thalidomide, lenalidomide and bortezomib have been used in both newly diagnosed and relapsed patients. Currently, there is intense clinical research on the optimal way to combine these novel agents with the traditional backbones of treatment - including alkylators, with one another and, eventually, with the subsequent iterations of these classes of drugs. However, despite the therapeutic excitement surrounding this disease, most patients will relapse and a cure remains an elusive goal.

Arms: arm 1: Bendamustine is combined with standard chemotherapy.
Interventions: intervention 1: Bendamustine
Intervention descriptions: intervention 1: The first group of three patients to enter the study will receive a 25 mg/m\^2 dose of bendamustine. If this dose is found to be safe, the next three patients will receive 50 mg/m\^2. Using a modified Fibonacci dose-escalation design, the dose will continue to increase at a rate of 25 mg/m\^2 until the highest safe dose of bendamustine is found. The maximum dose will be 125 mg/m\^2. Bendamustine and bortezomib will be given through a catheter twice a week every 21 days. Dexamethasone and lenalidomide will be given orally. In general, a cycle of chemotherapy will last 21 days.

Protocol documents:
Clinical trial NCT02071914
Conditions: Influenza A
Keywords: efficacy safety
Sponsor: Celltrion
Start date: 2014-02-15; Completion date: 2014-06-19
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from nasopharyngeal mucosa, compared to placebo.

Detailed description:
This study is a Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa study. All enrolled subjects will be given a single dose of 10 mg/kg CT-P27, 20 mg/kg CT-P27, or placebo intravenously and then followed by Day 36.

Arms: arm 1: CT-P27 will be administrated once in IV infusion. arm 2: CT-P27 will be administrated once in IV infusion. arm 3: Placebo will be administrated once in IV infusion.
Interventions: intervention 1: CT-P27 intervention 2: Placebo
Intervention descriptions: intervention 1: Influenza A treatment drug. intervention 2: Placebo.

Protocol documents:
Clinical trial NCT02125292
Conditions: Healthy
Sponsor: Shire
Start date: 2014-06-02; Completion date: 2014-06-19
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the palatability of SHP429 capsule contents delivered via 3 means of administration (sprinkled on yogurt, sprinkled on applesauce, and emptied into a cup and administered with water).

Detailed description:

Arms: arm 1: One 500mg capsule contents sprinkled onto 1 tablespoon of low-fat vanilla yogurt arm 2: One 500mg capsule contents sprinkled onto 1 tablespoon of applesauce arm 3: One 500mg capsule contents emptied into a dosing cup and taken with water
Interventions: intervention 1: Mesalamine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02045979
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-01-31; Completion date: 2014-06-20
Enrollment: 327 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish pharmacokinetic similarity of BI 695501 to adalimumab.

Detailed description:

Arms: arm 1: Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501 arm 2: Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-EU source arm 3: Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-US source
Interventions: intervention 1: BI 695501 intervention 2: adalimumab-EU source intervention 3: adalimumab-US source
Intervention descriptions: intervention 1: BI 695501 single s.c. injection intervention 2: adalimumab-EU source single s.c. injection intervention 3: adalimumab-US source single s.c. injection.

Protocol documents:
Clinical trial NCT01959243
Conditions: Hyperemia
Keywords: Ocular redness
Sponsor: Bausch & Lomb Incorporated
Start date: 2014-02-22; Completion date: 2014-06-23
Enrollment: 507 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants. At least 51% of participants will be 40 years of age or older.

Detailed description:

Arms: arm 1: Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks. arm 2: Participants will apply 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
Interventions: intervention 1: Brimonidine Tartrate intervention 2: Vehicle intervention 3: Sodium Fluorescein intervention 4: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
Intervention descriptions: intervention 1: Ophthalmic solution to be applied as directed. intervention 2: Ophthalmic solution to be applied as directed. intervention 3: For use as needed during the study for evaluating corneal damage. intervention 4: For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.

Protocol documents: