ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02828241
Conditions: Rosacea
Sponsor: Dr. Reddy's Laboratories Limited
Start date: 2016-07-01; Completion date: 2017-11-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this exploratory study is to assess the efficacy, safety and tolerability of DFD-04 Ointment for topical treatment of rosacea over 12 weeks of treatment.

Detailed description:
Subjects with mild to moderate papulopustular rosacea (Investigator's Global Assessment \[IGA\] grade 2-3), a Clinician's Erythema Assessment (CEA) score of 2-3 and 6-30 inflammatory lesions (papules and pustules) were randomized to treatment with DFD-04 ointment or Vehicle ointment in a ratio of 2:1.

During the 12-week treatment period subjects used the IMP twice daily with approximately 12 hours between applications. Subjects were instructed to treat affected skin in a defined treatment area on the face.

The investigator assessed efficacy by using an IGA 5-point scale and CEA 4-point scale and by counting the number of inflammatory lesions on the face at Baseline (Day 1) and Weeks 4, 8 and 12 (End of Treatment \[EoT\], defined as complete clearance of inflammatory lesions or Week 12, whichever was earlier). Furthermore, a non-invasive biomarker assessment was done by using a Transdermal Analysis Patch (TAP) at Baseline (Day 1) and Weeks 4 and 12.

Safety assessments included investigator's assessment of application site reactions at Baseline (Day 1) and Weeks 4, 8, and 12 for all treated areas.

Other safety assessments included vital signs (blood pressure \[BP\] and pulse rate) and urine pregnancy tests (UPTs) (only for females), clinical laboratory parameters (serum and urine), extent of exposure, and Adverse Events.

In addition, pharmacokinetic (PK) analysis was performed to evaluate the systemic exposures of itraconazole and its active metabolite, hydroxyl-itraconazole, with blood samples drawn from the first 12 subjects at various pre-specified timepoints.

Arms: arm 1: DFD-04 (Itraconazole) Ointment arm 2: Placebo Ointment
Interventions: intervention 1: DFD-04 Ointment intervention 2: Placebo Ointment
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02916407
Conditions: Entropion
Keywords: Anesthesia Agitation Extubation
Sponsor: Inje University
Start date: 2016-09-01; Completion date: 2017-11-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators evaluate extubation time and recovery profiles in children undergoing entropion surgery.

Detailed description:
This study will compare the extubation time and recovery profiles (degree of postoperative agitation and cough) between sevoflurane group and desflurane group. General anesthesia will maintained with sevoflurane 2-3vol% or desflurane 6-7vol%. After surgery, the investigators will measure the duration of extubation and recovery profiles between two groups.

Arms: arm 1: The patients will maintained general anesthesia with sevoflurane. arm 2: The patients will maintained general anesthesia with desflurane.
Interventions: intervention 1: Sevoflurane intervention 2: Desflurane
Intervention descriptions: intervention 1: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.

General anesthesia will maintained with sevoflurane 2-3 vol%. intervention 2: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.

General anesthesia will maintained with desflurane 6-7vol%.

Protocol documents:
Prot_SAP_000.pdf: 
ID: 2016-01      
The Effect of Preoperative Ketamine on the Emergence Characteristics in Children Undergoing 
Entropion Surgery      
NCT02916407 
04-25-2019 
We compared the emergence characteristics of sevoflurane versus desflurane with ketamine 
premedicated pediatric patients for ambulatory surgery. The primary outcome was compared the 
extubation time between sevoflurane versus desflurane anesthesia. The secondary outcome was 
compared the emergence characteristics (emergence agitation) between two groups. 
Patients were randomly assigned into group S (sevoflurane) or group D (desflurane). After 
intravenous access in day-surgery unit, ketamine 1mg/kg was administered for separation from their 
parents, and then they were transferred to operating room with monitoring pulse oximetry. General 
anesthesia was maintained with sevoflurane in group S or desflurane in group D.  
Data were analyzed using Medcalc 14.12.0 (MedCalc Software bvba, Ostend, Belgium). 
Parametric variables were described as mean ± standard deviation (SD). Qualitative variables 
were described as number and as median (interquartile range). Student’s t-test, Fisher’s exact 
test, or Mann-Whitney U-test was used as appropriate to compare the two groups. P < 0.05 was 
considered to indicate statistical significant. 
  
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Clinical trial NCT00974311
Conditions: Castration-Resistant Prostate Cancer
Keywords: Prostate Cancer Castration-resistant
Sponsor: Pfizer
Start date: 2009-09-30; Completion date: 2017-11-02
Enrollment: 1199 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.

Detailed description:

Arms: arm 1: Formerly MDV3100 arm 2: None
Interventions: intervention 1: Enzalutamide intervention 2: Placebo
Intervention descriptions: intervention 1: MDV3100, 160 mg orally per day intervention 2: Placebo comparator

Protocol documents:
Clinical trial NCT01877083
Conditions: KIF5B-RET-Positive Adenocarcinoma of the Lung
Keywords: KIF5B-RET-Positive Adenocarcinoma Lung Cancer NSCLC Non-Small Cell Lung Cancer
Sponsor: Eisai Inc.
Start date: 2013-04-05; Completion date: 2017-11-02
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 2, open-label, safety and activity study of lenvatinib in subjects with KIF5B-RET-positive adenocarcinoma of the lung and other confirmed RET translocations. At least 20 subjects with KIF5B-RET and other RET translocations will be treated and will receive lenvatinib at a starting dose of 24 mg orally, once per day. The study will consist of 3 phases: The Pretreatment Phase, The Treatment Phase and the Extension Phase. The Pretreatment Phase will include screening procedures and eligibility assessments. The Pretreatment Phase consists of a Screen 1, Screen 2 and Baseline Period. The Treatment Phase will begin when the subject has met all eligibility criteria on Day 1 of the first Treatment Cycle. The Treatment Phase contains the Treatment and Follow-up Periods. The Extension Phase will begin for subjects who received treatment in the study (either in the Treatment Period or Follow-up Period) at the time of database cutoff.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Lenvatinib
Intervention descriptions: intervention 1: Starting dose of 24 mg orally, once per day

Protocol documents:
Clinical trial NCT00737529
Conditions: Mantle Cell Lymphoma
Keywords: Mantle Cell Lymphoma Non-Hodgkin's Lymphoma CC-5013 Revlimid Lenalidomide
Sponsor: Celgene
Start date: 2008-12-22; Completion date: 2017-11-08
Enrollment: 134 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.

Detailed description:
Follow up phase will continue until either 100% of the patients have died, are lost to follow up or have withdrawn consent or a maximum of 4 years from the last patient enrolled, whichever comes first. All other efficacy and safety endpoints will be updated at this time. In the unlikely event that the study will be closed and patients are still responding to treatment at this time, Celgene will discuss with the treating physicians options to provide further treatment to the patient after study closure in line with local regulation.

Follow up for second primary malignancies and OS will continue until 100% of the patients have died, are lost to follow up, have withdrawn consent, or a maximum of 5 years from the last patient enrolled, whichever comes first.

10 October 2017: In regard to the last subject last visit date/study completion date, the prolongation of timelines is due to the bridging of a treatment gap for a patient responding to study medication until non-study medication is available.

Arms: arm 1: Single agent Lenalidomide

Lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but \< 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
Interventions: intervention 1: lenalidomide
Intervention descriptions: intervention 1: 25mg oral capsules continuous days 1-21 each of a 28 day cycle

Protocol documents:
Clinical trial NCT01288911
Conditions: Prostatic Neoplasms
Keywords: Metastatic MDV3100 Prostate progressive Cancer enzalutamide
Sponsor: Astellas Pharma Inc
Start date: 2011-03-22; Completion date: 2017-11-08
Enrollment: 375 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine the efficacy and safety of oral enzalutamide compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a bilateral orchiectomy.

Detailed description:
An open-label period was added to the main protocol. Following unblinding at the end of the double-blind period and demonstration of a statistically significant advantage of enzalutamide over bicalutamide as assessed by the primary endpoint, all ongoing enzalutamide treated participants and ongoing or previous bicalutamide treated participants that met entry criteria were offered open-label enzalutamide at the discretion of the participant and study investigators.

Arms: arm 1: Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy. arm 2: Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
Interventions: intervention 1: enzalutamide intervention 2: bicalutamide
Intervention descriptions: intervention 1: capsules intervention 2: tablets

Protocol documents:
Clinical trial NCT01686165
Conditions: Anaplastic Large Cell Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Mantle Cell Lymphoma
Sponsor: University of Arizona
Start date: 2012-08-31; Completion date: 2017-11-09
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study looks at what effects (good and bad) a drug called PXD-101 (belinostat) in combination with the radioactive drug Zevalin (yttrium Y 90 ibritumomab tiuxetan) has on patients with relapsed aggressive (high-risk) non-Hodgkin lymphoma. Studies in the laboratory suggest that drugs such as PXD101 can act upon specific cancer cell processes to cause either death of the cancer cells or prevention of their growth. In human studies with a small number of patients with this lymphoma, PXD-101 has shown the ability to shrink and slow tumor growth. When Zevalin is delivered directly to the tumor, the lymphoma cells are destroyed and this may result in the disappearance of the tumor (remission)

Detailed description:
PRIMARY OBJECTIVES:

I. To document the complete response rate and overall response for patients with relapsed aggressive high-risk non-Hodgkin's lymphoma treated with two cycles PXD-101 followed by one cycle of Zevalin.

SECONDARY OBJECTIVES:

I. To estimate 2-year progression-free survival in patients with relapsed aggressive high-risk non-Hodgkin's lymphoma treated with two cycles PXD-101 followed by one cycle of Zevalin.

II. To evaluate the toxicity of two cycles PXD-101 and one cycle of Zevalin in patients with relapsed aggressive high-risk non-Hodgkin's lymphoma.

OUTLINE:

Patients receive belinostat intravenously (IV) over 30-60 minutes on days 1-5. Treatment with belinostat repeats every 21 days for 2 courses. Patients then receive rituximab IV on days 1 and either 7, 8, or 9, and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 50. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Arms: arm 1: Patients receive belinostat IV over 30-60 minutes on days 1-5. Treatment with belinostat repeats every 21 days for 2 courses. Patients then receive rituximab IV on days 1 and either 7, 8, or 9, and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 50. Treatment continues in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: belinostat intervention 2: rituximab intervention 3: yttrium Y 90 ibritumomab tiuxetan
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV

Protocol documents:
Clinical trial NCT01773421
Conditions: Advanced Solid Tumors
Sponsor: Eisai Inc.
Start date: 2011-06-30; Completion date: 2017-11-12
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study consists of two Parts. Part A (Food Effect Study) and Part B (Determination of Maximum Tolerated Dose \[MTD\] for twice daily \[BID\] Dosing).Part A will be initiated first, and Part B will be initiated after the PK results of Part A have been evaluated.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: E7820 intervention 2: E7820
Intervention descriptions: intervention 1: FOOD EFFECT STUDY:

Each subject (a minimum of 12 subjects) will be assigned according to a randomization code to receive a single 50 mg dose of E7820 on Day 1, either after fasting for 10 hours, or immediately after consuming a high fat breakfast. Following a 7-day washout period, the subjects will crossover and a second 50 mg dose of E7820 will be administered on Day 8. intervention 2: MTD DETERMINATION FOR BID DOSING SCHEDULE

The initial dose of E7820 will be 50 mg BID. If allowed by the rules for dose escalation, the dose escalations will be to 60 mg BID, 80 mg BID, and 100 mg BID.

Protocol documents:
Clinical trial NCT00805194
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2008-12-03; Completion date: 2017-11-13
Enrollment: 1314 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In addition, blood will be collected for pharmacokinetic analysis.

Detailed description:

Arms: arm 1: BIBF 1120 2 times daily along with standard therapy of docetaxel arm 2: Placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel
Interventions: intervention 1: placebo plus docetaxel intervention 2: BIBF 1120 plus docetaxel
Intervention descriptions: intervention 1: placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel intervention 2: BIBF 1120 2 times daily along with standard therapy of docetaxel

Protocol documents:
Clinical trial NCT00904488
Conditions: Acute Decompensated Heart Failure
Keywords: Acute Decompensated Heart Failure Diuretics
Sponsor: University of North Carolina, Chapel Hill
Start date: 2008-10-01; Completion date: 2017-11-14
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this prospective, randomized, open-label study is to compare two diuretic strategies in patients with acute decompensated heart failure (ADHF): the addition of an oral thiazide diuretic to intravenous bolus (IVB) loop diuretic will be compared to transition from IVB to continuous infusion (CI) loop diuretic.

Detailed description:
Patients hospitalized for ADHF secondary to fluid overload and who are experiencing an inadequate response to IVB furosemide and require additional diuresis will be enrolled. Patients will be randomized to one of two treatment arms: the addition of oral metolazone to continued IVB furosemide versus transition from IVB to CI furosemide. A suggested algorithm for initial dosing and titration of these two diuretic strategies will be provided. Baseline and daily data collection will include various efficacy and safety endpoints including daily net urine output and weight, patient and physician global assessment scale, length of stay, 30-day death or rehospitalization, vital signs, electrolytes, and renal function. Clinically meaningful efficacy and safety endpoints will be compared.

Arms: arm 1: Addition of oral metolazone 5 mg daily to current intravenous bolus furosemide. All subjects will continue their current dose of intravenous bolus furosemide. arm 2: Current IV furosemide dose will be escalated to 2-2.5 x current dose, given as either IV bolus or continuous infusion over 24 hours.
Interventions: intervention 1: Addition of oral Metolazone intervention 2: Furosemide dose escalation
Intervention descriptions: intervention 1: Addition of oral metolazone 5 mg daily to continued current dose of intravenous bolus furosemide intervention 2: Furosemide dose escalation via either IV bolus (2-2.5 x current dose) or continuous infusion (2-2.5 x current dose administered over previous 24 hours)

Protocol documents:
Clinical trial NCT02634801
Conditions: Plaque Psoriasis
Keywords: Fumaderm
Sponsor: Eli Lilly and Company
Start date: 2016-01-20; Completion date: 2017-11-14
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque psoriasis who are naive to systemic treatment.

Detailed description:

Arms: arm 1: 160 milligrams (mg) ixekizumab given as two subcutaneous injections (SC) followed by 80 mg ixekizumab given SC every 2 weeks until week 12 and then 80 mg ixekizumab given SC every 4 weeks until week 24.

Extension Period: At week 24, participants have the option to continue ixekizumab treatment for up to 36 weeks. arm 2: Starting dose of 105 mg FAE given orally followed by 215 mg FAE given orally 1 to 3 times per day until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks. arm 3: 7.5 mg starting dose up to 30 mg MTX given orally once a week until week 24.

Extension Period: At week 24, participants have the option to begin ixekizumab treatment for up to 36 weeks.
Interventions: intervention 1: Fumaric Acid Esters intervention 2: Methotrexate intervention 3: Ixekizumab
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered SC

Protocol documents:
Clinical trial NCT00716586
Conditions: Retinal Degenerations
Sponsor: University of Illinois at Chicago
Start date: 2005-10-01; Completion date: 2017-11-17
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A small percentage of patients with retinal degeneration accumulate fluid in the center of their retina.

Previous studies using an oral form of treatment has been successful in decreasing this fluid which improves vision.

This study will test the use of a topically applied form of this treatment to the eye to reduce the amount of fluid and improve or preserve vision.

Detailed description:
Patients with certain retinal degenerations will be asked to take part in a research study about the use of a topically applied eye drop for treating fluid in the central part of the retina (macular edema).

In the current study, investigators propose to use topical Trusopt in a group of patients with retinal degeneration (RD) to determine its effectiveness in reducing the amount of retinal fluid in patients with RD and macular edema. The methods will involve an initial one month treatment with topical Trusopt three times a day in each eye. After a period of one month, patients will return for a follow-up examination. At baseline, they will have had a measurement of their center vision and a measurement of their macular fluid with a photographic-like procedure termed optical coherence tomography (OCT). After the one month period of treatment, they will again have a measurement of their vision and re-evaluation with OCT. An improvement at least of one line (7 letters) or more of vision will be considered as a clinically significant improvement.

Arms: arm 1: Intent to treat population. All participants assigned to Trusopt (2% dorzolamide)
Interventions: intervention 1: 2% dorzolamide
Intervention descriptions: intervention 1: Carbonic anhydrase inhibitor, Trusopt (2% dorzolamide)

Protocol documents:
Clinical trial NCT01292603
Conditions: Lymphocytic Leukemia, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2011-04-18; Completion date: 2017-11-17
Enrollment: 240 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
This randomized, parallel-group, multi-center study will compare the pharmacokinetics and safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in combination with chemotherapy in previously untreated patients with chronic lymphocytic leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6 cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug is 24 weeks.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Cyclophosphamide intervention 2: Fludarabine intervention 3: rituximab [MabThera] intervention 4: rituximab [MabThera] intervention 5: rituximab [MabThera]
Intervention descriptions: intervention 1: Days 1-3 or Days 1-5 of cycles 1-6 intervention 2: Days 1-3 or Days 1-5 of cycles 1-6 intervention 3: One cycle of intravenous MabThera, followed by 5 cycles of subcutaneous MabThera intervention 4: After 4 cycles of intravenous MabThera without experiencing grade 3 or 4 infusion-related reactions. patients will receive 1 additional cycle of intravenous MabThera and 1 cycle of subcutaneous MabThera. intervention 5: 6 cycles of intravenous MabThera

Protocol documents: