ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01454934
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Eisai Inc.
Start date: 2011-12-09; Completion date: 2016-05-02
Enrollment: 540 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety of eribulin with TPC in subjects with advanced and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Eribulin intervention 2: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed
Intervention descriptions: intervention 1: Administration of eribulin mesylate at a dose of 1.4 mg/m2 i.v. over 2 to 5 minutes on Days 1 and Day 8 of every cycle, where the duration of each cycle is 21 days. intervention 2: * Vinorelbine 30 mg/m2 i.v. on Day 1, every 7 days
* Gemcitabine 1250 mg/m2 i.v. on Days 1 and 8, every 21 days
* Docetaxel 75 mg/m2 i.v. on Day 1 every 21 days
* Pemetrexed 500 mg/m2 i.v. on Day 1 every 21 days (nonsquamous histology only).

Protocol documents:
Clinical trial NCT01935089
Conditions: HIV-1 Infection
Keywords: HIV-1 Interferon alpha Integrated DNA Latent reservoir
Sponsor: The Wistar Institute
Start date: 2013-08-07; Completion date: 2016-05-02
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We propose to test our primary hypothesis that treatment with Peg-IFN-α-2b will result in a decrease in integrated HIV DNA in peripheral blood and tissue in chronically HIV-infected immune-reconstituted individuals (see section 3.1) in a prospective, interventional, 1-arm, open label clinical trial. To this end, we propose to enroll 25 HIV-1-infected subjects (please refer to power calculations in section 10.1 below) currently stably suppressed (\> 1y with VL \< 50 copies/ml) on ART and with CD4 count \> 450 cells/µl.

We hypothesize that 20 weeks of treatment with Peg-IFN-alpha-2b, in the presence of HIV reactivation (i.e.: ART interruption), will result in activation of intrinsic and/or immune-mediated anti-HIV mechanisms resulting in a decrease in the levels of viral reservoir in chronically HIV-infected, immune-reconstituted individuals.

Detailed description:

Arms: arm 1: pegylated Interferon alpha 2b (Pegintron) 1 µg/kg per week, 20 weeks
Interventions: intervention 1: Pegylated Interferon alpha 2b
Intervention descriptions: intervention 1: 1µg/kg/week

Protocol documents:
Clinical trial NCT02097849
Conditions: Relapsing Forms of Multiple Sclerosis
Keywords: vaccine pneumococcal meningococcal tetanus diphtheria immune response
Sponsor: Biogen
Start date: 2015-02-28; Completion date: 2016-05-02
Enrollment: 71 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN).

Secondary objective is to evaluate the immune response to vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) \[a mostly T cell-independent humoral response\] and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) \[T cell-dependent neoantigen response\].

Detailed description:

Arms: arm 1: Participants on a stable approved dose of a non pegylated IFN for ≥3 months will receive 3 vaccinations on Day 1 intramuscularly in the specified order:

Td 0.5 mL PPSV23 0.5 mL MCV4 0.5 mL arm 2: Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥6 months will receive 3 vaccinations on Day 1 intramuscularly in the specified order:

Td 0.5 mL PPSV23 0.5 mL MCV4 0.5 mL
Interventions: intervention 1: dimethyl fumarate intervention 2: tetanus diphtheria toxoids vaccine intervention 3: 23-valent pneumococcal polysaccharide vaccine intervention 4: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent) intervention 5: non-pegylated interferon
Intervention descriptions: intervention 1: Throughout the study participants will remain on their existing, stable dosing regimen of Tecfidera. intervention 2: Administered as described in the treatment arm intervention 3: Administered as described in the treatment arm intervention 4: Administered as described in the treatment arm intervention 5: Throughout the study participants will remain on their existing, stable dosing regimen of non-pegylated IFN.

Protocol documents:
Clinical trial NCT02387983
Conditions: Fungal Infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2015-05-06; Completion date: 2016-05-02
Enrollment: 65 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics and safety of oral posaconazole tablets in Chinese participants at high risk for invasive fungal infections. Neutropenic participants undergoing chemotherapy for acute myelogenous leukemia or myelodysplastic syndromes will be enrolled in the study.

Detailed description:

Arms: arm 1: Posaconazole 300 mg tablet (3 x 100 mg tablets) once every 12 hours on Day 1 and once-daily on Days 2 to 28
Interventions: intervention 1: Posaconazole
Intervention descriptions: intervention 1: Posaconazole 300 mg solid oral tablet

Protocol documents:
Clinical trial NCT02547714
Conditions: Plaque Psoriasis
Keywords: cyclosporine A
Sponsor: Novartis Pharmaceuticals
Start date: 2015-06-16; Completion date: 2016-05-02
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the efficacy and safety of secukinumab at Week 16 based on psoriasis area and severity index (PASI) 75 in subjects who had inadequate response to cyclosporine A.

Detailed description:

Arms: arm 1: Participants received secukinumab 300 mg subcutaneously (s.c.) (two 150 mg injections) on Day 1 and at Weeks 1, 2, 3, 4, 8 and 12.
Interventions: intervention 1: Secukinumab (AIN457)
Intervention descriptions: intervention 1: Secukinumab was supplied as 150 mg doses, provided in 1 mL prefilled syringes.

Protocol documents:
Clinical trial NCT01283516
Conditions: Tumors Characterized by Genetic Abnormalities of ALK
Keywords: ALK inhibitor, NSCLC, LDK378, ceritinib, genetic abnormalities
Sponsor: Novartis Pharmaceuticals
Start date: 2011-01-24; Completion date: 2016-05-03
Enrollment: 304 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the safety and efficacy of LDK378 in adult patients with genetic abnormalities in anaplastic lymphoma kinase (ALK).

Detailed description:

Arms: arm 1: NSCLC patients previously treated with an ALK inhibitor arm 2: NSCLC patients not previously treated with an ALK inhibitor arm 3: Patients with other tumors that are ALK positive other than NSCLC
Interventions: intervention 1: LDK378
Intervention descriptions: intervention 1: LDK378 is a selective and a potent inhibitor of anaplastic lymphoma kinase (ALK) activity, is a capsule and is administered orally.

Protocol documents:
Clinical trial NCT02031432
Conditions: Pain Neoplasms Chronic Pain
Keywords: cancer-related pain cebranopadol
Sponsor: Tris Pharma, Inc.
Start date: 2013-12-18; Completion date: 2016-05-03
Enrollment: 76 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial was to find out how well cebranopadol is tolerated and how often, and which, adverse reactions occur when it is taken every day for a longer period of time. In addition, information was collected how cebranopadol affects pain and well-being in patients suffering from cancer-related pain.

Detailed description:
The trial consisted of 3 phases: Titration Phase, Maintenance Phase, and Follow-Up. The total duration of the trial was approximately 28 weeks for each individual participant, including the Follow-up. The participants received cebranopadol for a maximum of approximately 26 weeks.

Arms: arm 1: Cebranopadol 200 µg to 1000 µg per taken taken once a day in the morning.

Allowed dose levels in the Maintenance Phase were 200, 400, 600, 800, or 1000 µg per day.
Interventions: intervention 1: Cebranopadol
Intervention descriptions: intervention 1: Film-coated tablet; strengths: 200, 400, or 600 µg

Protocol documents:
Clinical trial NCT02258529
Conditions: Follicular Lymphoma Small Lymphocytic Lymphoma
Keywords: Cancer Indolent Non-Hodgkin Lymphoma FL SLL
Sponsor: Gilead Sciences
Start date: 2015-09-14; Completion date: 2016-05-03
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the overall response rate (ORR) and complete response (CR) rate to treatment with idelalisib in combination with rituximab in previously untreated adults with follicular lymphoma (FL) or small lymphocytic lymphoma (SLL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.

Detailed description:

Arms: arm 1: Idelalisib + rituximab for up to 104 weeks
Interventions: intervention 1: Idelalisib intervention 2: Rituximab
Intervention descriptions: intervention 1: 150 tablets administered orally twice daily intervention 2: 375 mg/m\^2 administered intravenously (weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)

Protocol documents:
Clinical trial NCT01271010
Conditions: Lymphocytic Leukemia, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2011-06-17; Completion date: 2016-05-04
Enrollment: 89 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multi-center, single-arm study evaluated the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide in participants with B-cell chronic lymphocytic leukemia (CLL) and favorable somatic status.

Detailed description:

Arms: arm 1: Participants received rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m\^2 IV or 40 mg/m\^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m\^2 IV or 250 mg/m\^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
Interventions: intervention 1: Cyclophosphamide intervention 2: Fludarabine intervention 3: Rituximab
Intervention descriptions: intervention 1: Participants received cyclophosphamide 250 mg/m\^2 IV or 250 mg/m\^2 orally on Days 1-3 of each cycle. intervention 2: Participants received fludarabine 25 mg/m\^2 IV or 40 mg/m\^2 orally on Days 1-3 of each cycle. intervention 3: Participants received 375 mg/m\^2 IV on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle.

Protocol documents:
Clinical trial NCT02131662
Conditions: Leiomyoma
Keywords: Uterine fibroids
Sponsor: Bayer
Start date: 2014-05-15; Completion date: 2016-05-04
Enrollment: 309 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is performed to assess the efficacy and safety of different doses of BAY1002670 in subjects with uterine fibroids. The dose-response relationship will be evaluated. Further, the study aims to establish a population pharmacokinetic/pharmacodynamic relationship for BAY1002670 in subjects with uterine fibroids. To assess the efficacy of BAY1002670 the interchangeability of menstrual pictogram and alkaline hematin method for the judgement of menstrual blood loss will be assessed.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: BAY1002670 intervention 2: BAY1002670 intervention 3: BAY1002670 intervention 4: BAY1002670 intervention 5: Placebo
Intervention descriptions: intervention 1: Subjects received 4 milligram (mg) Vilaprisan (VPR) tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. intervention 2: Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. intervention 3: Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. intervention 4: Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization. intervention 5: Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.

Protocol documents:
Clinical trial NCT00634049
Conditions: Aspergillosis Invasive Fungal Infections
Keywords: invasive fungal infections caused by rare molds, rare yeasts BAL8557 Isavuconazole Aspergillosis or by dimorphic fungi ASP9766
Sponsor: Astellas Pharma Inc
Start date: 2008-04-22; Completion date: 2016-05-05
Enrollment: 149 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal disease caused by rare fungi.

Detailed description:
Acute invasive fungal infections caused by aspergillus, rare moulds, yeasts or dimorphic fungi are life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. This study investigates the safety and efficacy of isavuconazole in participants with aspergillosis and renal impairment, and in participants suffering from invasive infections from rare fungi.

Arms: arm 1: Administration of isavuconazole 3 times a day in the vein (IV) or oral as a capsule for 2 days followed by daily administration of isavuconazole (IV) or oral
Interventions: intervention 1: isavuconazole
Intervention descriptions: intervention 1: Administration of 200 mg isavuconazole 3 times a day in the vein (IV) or oral as a capsule for 2 days, followed by daily administration of 200 mg isavuconazole (IV) or oral

Protocol documents:
Clinical trial NCT02722239
Conditions: Diabetes Mellitus, Type 2
Keywords: Xigduo; bioequivalence; crossover; Russia
Sponsor: AstraZeneca
Start date: 2016-03-30; Completion date: 2016-05-05
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aim of this study is to demonstrate bioequivalence of fixed dose combination Dapagliflozin + Metformin modified -release, film-coated tablets, 10 mg + 1000 mg, (AstraZeneca AB, Sweden) versus Forxiga™ (Dapagliflozin), film-coated tablets, 10 mg (Bristol Myers Squibb Company, USA) and Glucophage® long (Metformin), ER tablets, 1000 mg (2 x 500 mg) (Merck Santé S.A.S., France) which are already registered in the Russian Federation.

Detailed description:
Randomised open-label crossover comparative, single center, two periods, clinical study of investigational drug and reference drugs bioequivalence evaluation with a single administration of the study drug (1 modified - release film-coated tablets of Dapagliflozin + Metformin or 1 film-coated tablets of Forxiga™ + 2 tablets ER of Glucophage® long) under fed condition in healthy volunteers.

Arms: arm 1: Test product (T): a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release. Volunteers enrolled to group 1, on the first study period will take the study test product (Т), and on the second study period after wash out period of 7 days the volunteers will be given the Reference product (R) arm 2: Reference product (R): co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long). Volunteers from group 2 will be administered with the study drug in reverse order. It means that group 1 will take the study products in sequence T-R and group 2 in the sequence R-T.
Interventions: intervention 1: Xigduo XR intervention 2: Metformin ER (Glucophage® long) intervention 3: Dapagliflozin (Forxiga)
Intervention descriptions: intervention 1: a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release intervention 2: co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long). intervention 3: co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).

Protocol documents:
Clinical trial NCT02746263
Conditions: Acute Pain, Postoperative
Keywords: Elective total knee arthroplasty
Sponsor: Mallinckrodt
Start date: 2016-04-27; Completion date: 2016-05-05
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare intravenous (IV) and oral acetaminophen for the treatment of acute moderate to severe pain in combination with standard patient-controlled analgesia (PCA) in adult subjects following total knee replacement.

Detailed description:

Arms: arm 1: IV acetaminophen 1000 mg every 6 hours over 18 hours arm 2: Oral acetaminophen two 500 mg tablets every 6 hours over 18 hours
Interventions: intervention 1: IV acetaminophen intervention 2: Oral acetaminophen intervention 3: Morphine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Patient controlled analgesia

Protocol documents:
Clinical trial NCT02096900
Conditions: Parental/Caregiver Anxiety Child's Anxiety
Keywords: Pre-medication Pre-operative anxiety
Sponsor: Loma Linda University
Start date: 2014-07-21; Completion date: 2016-05-06
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this investigator-initiated study is to compare the efficacy of oral midazolam and zolpidem for preoperative sedation, anxiety of patient, and caregiver anxiety at the time of separation, and ease of mask acceptance at induction in children. Subjects will be randomized to receive oral medication midazolam or zolpidem approximately 30 minutes prior to surgery. No placebo will be administered in this study. Subjects will be male and female children between 2 and 9 years of age. In total, subject participation will last approximately the duration of their preoperative, perioperative, and immediate postoperative period. A member of the research team will recruit subjects preoperatively in the operating room holding area prior to surgery. Consent will take place at the time of recruitment in the preoperative holding area following a detailed explanation of the study and medications involved in the study. Participants will be of ASA (American Society of Anesthesiologists) class I-II, undergoing surgical procedures of at least 2 hours duration, and expected to remain inpatient for at least 23 hours postoperatively.

Detailed description:

Arms: arm 1: zolpidem given orally 0.25mg/kg pre-operatively single dose arm 2: midazolam will be given at 0.5mg/kg, pre-operatively single dose
Interventions: intervention 1: zolpidem intervention 2: Midazolam
Intervention descriptions: intervention 1: Zolpidem will be given one time at 0.25 mg/kg pre-operatively intervention 2: None

Protocol documents:
Clinical trial NCT02448043
Conditions: Nail Growth Cessation Intraocular Pressure
Keywords: brittleness
Sponsor: Northwestern University
Start date: 2015-06-04; Completion date: 2016-05-06
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Topical prostaglandin agents are used to help reduce eye pressure in glaucoma patients. Bimatoprost (Lumigan 0.01%) is such an agent (Allergan, Inc.). Several of our patients on bimatoprost and an observational study of patients on bimatoprost in another center reported that fingernails grew longer and became less brittle using the topical eye drops to the eyes. The purpose of the double-blinded study is to determine whether the application of the eye drops directly to the proximal nail fold of one hand using the opposite hand as a control will result in longer nails, less brittle nails, and reduced eye pressures should any of the medication be absorbed into the systemic circulation.

Detailed description:
In addition to our observations with topical bimatoprost on fingernail growth, Wand and colleagues applied bimatoprost to the base of the fingernails demonstrating a 16.9% increase in fingernail growth from baseline, and a 10.4% increase from baseline on untreated nail beds. Other than these two reports, there are no studies addressing this topic to our knowledge based on a Medline search for off-label use of this drug. Other relevant studies have addressed increased hair and eyelash growth with the prostaglandin agents. Researching the biochemistry of the relationship of prostaglandins to hair and nail growth, the final common pathway appears to be with protein kinase C and the production of tropocollagens. The dermatology literature has demonstrated that both hair and nail keratocytes reside in the nail bed suggesting that increased collagen production may enhance the growth of both the nail bed and nail plate, possibly reducing nail brittleness.

Arms: arm 1: * Bimatoprost 0.01% drops placed on the proximal nail folds of the right hand digits two times per day for 30 days.
* Saline solution drops placed on the proximal nail folds of the left hand digits two times per day for 30 days. arm 2: * Bimatoprost 0.01% drops placed on the proximal nail folds of the left hand digits two times per day for 30 days.
* Saline solution drops placed on the proximal nail folds of the right hand digits two times per day for 30 days.
Interventions: intervention 1: Bimatoprost 0.01% intervention 2: Placebo: saline
Intervention descriptions: intervention 1: Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days intervention 2: Placebo drops added to the proximal nail folds of the hand digits opposite the study hand two times per day for 30 days

Protocol documents: