ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01847638
Conditions: Cataract Retinal Edema Inflammation
Keywords: Retinal edema Cataract inflammation
Sponsor: Melissa Toyos
Start date: 2013-04-01; Completion date: 2018-08-23
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate inflammation, visual acuity and macular thickness after treatment with Prolensa vs Ilevro after cataract surgery.

Detailed description:
To investigate the clinical outcomes for inflammation, visual acuity and macular thickness after treatment with Prolensa (bromfenac ophthalmic solution) 0.07% QD in subjects who have undergone cataract extraction with posterior chamber intraocular lens implantation.

Arms: arm 1: Subjects will instill one drop Prolensa (bromfenac 0.07%) into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery. arm 2: Subjects will instill one drop into the study (operative) eye once daily for a maximum of 25 days. Dosing will begin three days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery.
Interventions: intervention 1: Prolensa (bromfenac 0.07%) intervention 2: Ilevro (nepafenac 0.3%)
Intervention descriptions: intervention 1: Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery intervention 2: Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery

Protocol documents:
Clinical trial NCT01806259
Conditions: Curative Breast Cancer Surgery Inflammatory Positive/Negative Status Pre Surgical Incision Administration
Sponsor: Université Catholique de Louvain
Start date: 2013-02-01; Completion date: 2018-09-01
Enrollment: 203 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Do the use of Ketorolac in one intravenous injection at the moment of the operative incision reduce the number of recurrence in patient with advanced breast cancer without inflammation signs.

Detailed description:

Arms: arm 1: Active drug to be compared with placebo arm 2: Placebo looking like the Active drug
Interventions: intervention 1: Ketorolac 30 mg IV intervention 2: Placebos
Intervention descriptions: intervention 1: Active drug intervention 2: Placebo looking like the Active drug

Protocol documents:
Clinical trial NCT00423735
Conditions: Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Neoplasm
Sponsor: National Cancer Institute (NCI)
Start date: 2007-01-24; Completion date: 2018-09-04
Enrollment: 64 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well dasatinib works in treating patients with glioblastoma multiforme or gliosarcoma that has come back. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the therapeutic efficacy of dasatinib in all patients (i.e., stages 1B and 2 combined) with recurrent/progressive glioblastoma (GBM) as measured by 6-month progression-free survival.

SECONDARY OBJECTIVES:

I. To determine the therapeutic efficacy of dasatinib for stage 1B patients with recurrent/progressive GBM as measured by a hybrid endpoint of 6-month progression-free survival OR objective response of (complete response \[CR\] or partial response \[PR\]) rate.

II. To determine patient overall survival. III. To determine the toxicity of dasatinib in the treatment of patients with GBM.

IV. To determine radiographic response rate to treatment. V. To determine patient progression-free survival. VI. To explore molecular correlates of clinical outcome. VII. To explore pharmacokinetic correlates of dosing, toxicity, and efficacy.

OUTLINE:

Patients receive dasatinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.

After the completion of study treatment, patients are followed up periodically.

Arms: arm 1: Patients receive dasatinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
Interventions: intervention 1: Dasatinib intervention 2: Pharmacological Study
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT03271021
Conditions: Acne Vulgaris
Sponsor: Vyne Therapeutics Inc.
Start date: 2017-07-17; Completion date: 2018-09-04
Enrollment: 1488 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)

Detailed description:
This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline compared to vehicle in the treatment of subjects with moderate-to-severe facial acne vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments:

* FMX101 4% minocycline foam
* Vehicle foam

Arms: arm 1: FMX101, 4% minocycline foam applied topically once daily for 12 weeks arm 2: Vehicle foam applied topically once daily for 12 weeks
Interventions: intervention 1: FMX101 intervention 2: Vehicle Foam
Intervention descriptions: intervention 1: FMX101, 4% minocycline foam intervention 2: Vehicle Foam

Protocol documents:
Prot_000.pdf: 





SAP_001.pdf:
Clinical trial NCT00709995
Conditions: Metastatic Renal Cell Carcinoma
Sponsor: Eli Lilly and Company
Start date: 2008-06-30; Completion date: 2018-09-05
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the effects of Enzastaurin plus Sunitinib versus Sunitinib alone in metastatic Renal Cell Cancer.

Detailed description:
This is a multicenter, Phase 2 study of enzastaurin and sunitinib versus placebo and sunitinib as first-line therapy in participants with metastatic renal cell carcinoma, containing 2 parts. Part 1 is a safety lead-in study with 12 participants and possible dose escalation. Part 2 is a randomized, double-blind, Phase 2 study in 110 participants.

Arms: arm 1: (Cohort 1): On cycle 1, day 1 a loading dose 125 milligram (mg) of Enzastaurin was administered by mouth orally, (BID) twice a day, followed by Enzastaurin 125 mg administered, twice a day, Days 2 through 42 of a 6-week cycle.

(Cohort 2): Cycle 1, Day 1 loading dose 375 mg of Enzastaurin administered po three times a day (TID), followed by 250 mg, po, BID continuously until disease progression, unacceptable toxicity, death, or discontinuation from the study for any other reason.

Sunitinib 50 mg was administered orally, once daily, Days 1-28, then rest (no drug given) days 29-42.

Phase 2 (Part 2): Randomized Double-Blind: Dosing was determined by Part 1. Part 2 was not activated per recommendation of safety review committee.

Enzastaurin: Cycle 1, Day 1 loading dose 375 mg administered orally, (TID) three times a day, followed by Part 1 dose twice a day on Days 2-42 of 6 week cycle.

Sunitinib: 50 mg administered orally, once daily, on Days 1-28, then rest Days 29-42. arm 2: Part 2 was not activated per recommendation of safety review committee.

Sunitinib: 50 mg administered orally, once daily, Day 1-28, then rest Days 29-42.

Placebo: Cycle 1 Day 1 loading dose 3 tablets on Day 1, then 2 tablets daily, days 2-42.
Interventions: intervention 1: Enzastaurin intervention 2: Sunitinib intervention 3: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol documents:
Clinical trial NCT01705574
Conditions: Acquired Immunodeficiency Syndrome HIV Infections
Keywords: HIV-1 HIV Treatment-Naive Women WAVES
Sponsor: Gilead Sciences
Start date: 2012-10-24; Completion date: 2018-09-06
Enrollment: 583 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.

Detailed description:

Arms: arm 1: E/C/F/TDF + ATV placebo + RTV placebo + FTC/TDF placebo arm 2: ATV + RTV + FTC/TDF + E/C/F/TDF placebo arm 3: After 48 weeks of blinded treatment, participants will continue to take blinded study drug for 12 weeks and return for an unblinding visit at Week 60. Participants who are virologically suppressed at Week 48 during the double-blinded treatment phase will have the option to enter the open-label extension phase. Participants randomized to the E/C/F/TDF arm will continue to receive open-label E/C/F/TDF and participants randomized to the ATV+ RTV + FTC/TDF arm will be re-randomized to receive either open-label elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or open-label ATV + RTV+ FTC/TDF.
Interventions: intervention 1: E/C/F/TDF intervention 2: ATV intervention 3: RTV intervention 4: FTC/TDF intervention 5: E/C/F/TDF Placebo intervention 6: ATV Placebo intervention 7: RTV Placebo intervention 8: FTC/TDF Placebo intervention 9: E/C/F/TAF
Intervention descriptions: intervention 1: 150/150/200/300 mg FDC tablet administered orally with food once daily intervention 2: 300 mg capsule administered orally with food once daily intervention 3: 100 mg tablet administered orally with food once daily intervention 4: 200/300 mg tablet administered orally with food once daily intervention 5: Tablet administered orally with food once daily intervention 6: Tablet administered orally with food once daily intervention 7: Capsule administered orally with food once daily intervention 8: Tablet administered orally with food once daily intervention 9: 150/150/200/10 mg FDC tablet administered orally with food once daily

Protocol documents:
Clinical trial NCT01903993
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2013-08-06; Completion date: 2018-09-06
Enrollment: 287 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multicenter, open-label, randomized study will evaluate the efficacy and safety of Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small cell lung cancer after platinum failure. Participants will be randomized to receive either Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per meter square (mg/m\^2) intravenously every 3 weeks. Treatment with Atezolizumab may be continued as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Detailed description:

Arms: arm 1: Participants received docetaxel 75 milligram per meter square (mg/m\^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death. arm 2: Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
Interventions: intervention 1: Docetaxel intervention 2: Atezolizumab
Intervention descriptions: intervention 1: Participants received starting dose of 75 mg/m\^2 every three week (q3w) until disease progression, unacceptable toxicity or death. Dose modifications were according to the locally approved label. Participants randomized to receive docetaxel had to be premedicated with corticosteroids according to local practice. intervention 2: Participants received atezolizumab of 1200 mg (equivalent to an average body weight-based dose of 15 milligram per kilogram \[mg/kg\]) which was administered by IV infusion q3w on Day 1 of each 21 day cycle. Participants were allowed to continue treatment beyond progression per response evaluation criteria in solid tumors (RECIST) v1.1 if they were experiencing clinical benefit per investigator, did not have a decline in performance status, did not have signs or symptoms of unequivocal progression, did not have tumor progression at critical sites, and signed an informed consent signature page acknowledging deferment any standard treatment options that may exist in favor of continuing atezolizumab.

Protocol documents:
Clinical trial NCT03109418
Conditions: Sleep Apnea Obstructive Sleep Apnea Postoperative Complications
Keywords: Ketamine Postoperative morbidity
Sponsor: University of Alabama at Birmingham
Start date: 2016-06-02; Completion date: 2018-09-12
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea.

Detailed description:
Obstructive sleep apnea (OSA) affects millions of people in the U.S., and currently, there is not a well-established, general anesthetic technique that clearly decreases the risk of postoperative respiratory complications in these patients. If OSA patients have significantly decreased postoperative opioid requirements and improved recovery profiles in the PACU, the protocol could have significant implications in defining future standardized general anesthesia recommendations for patients with this disease. Ultimately, the aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea. The objective of this study is to compare the postoperative recovery profile of OSA patients receiving standard Sevoflurane inhaled anesthesia with normal saline infusion versus Sevoflurane combined with a low-dose ketamine infusion.

Arms: arm 1: OSA patients will receive standard inhaled anesthesia with normal saline infusion arm 2: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.
Interventions: intervention 1: Ketamine intervention 2: Control
Intervention descriptions: intervention 1: OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight intervention 2: OSA patients receiving standard inhaled anesthesia combined with normal saline

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT02038049
Conditions: Relapse Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis Magnetic Resonance Imaging VAY736 Lanalumab monoclonal antibody gadolinium [Gd]-enhancing lesions B-Cell
Sponsor: Novartis Pharmaceuticals
Start date: 2013-12-20; Completion date: 2018-09-13
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a randomized, partially blinded, placebo-controlled, non-confirmatory study to assess the effects of a single infusion of VAY736 on disease activity as measured by brain MRI scans in patients with relapsing-remitting multiple sclerosis (RRMS).

Detailed description:
The study was planned to be conducted in approximately 96 patients. However, after enrolling 8 patients, the recruitment was terminated based on strategic considerations.

Arms: arm 1: Intravenous infusion of VAY736 arm 2: Matching placebo (infusion bag) administered intravenously. Placebo randomized patients were offered optional VAY736 administration after week 16
Interventions: intervention 1: VAY736 intervention 2: Placebo
Intervention descriptions: intervention 1: Single intravenous infusion of VAY736 (10 mg/kg) intervention 2: Placebo to VAY736

Protocol documents:
Clinical trial NCT03196973
Conditions: Acute Otitis Externa
Sponsor: Salvat
Start date: 2017-07-22; Completion date: 2018-09-14
Enrollment: 493 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE

Detailed description:

Arms: arm 1: Otic solution arm 2: Otic solution arm 3: Otic solution
Interventions: intervention 1: DF289 plus DF277 intervention 2: DF289 intervention 3: DF277
Intervention descriptions: intervention 1: 1 vial into the affected ear twice daily for 7 days intervention 2: 1 vial into the affected ear twice daily for 7 days intervention 3: 1 vial into the affected ear twice daily for 7 days

Protocol documents:
SAP_002.pdf: 



































































Prot_000.pdf:
Clinical trial NCT01649375
Conditions: Anklyosing Spondylitis
Keywords: Ankylosing spondylitis AS Chronic inflammatory disease Inflammatory back pain Secukinumab Prefilled syringe PFS Subcutaneous injection AIN457 AIN457F AIN457F2310 adult
Sponsor: Novartis Pharmaceuticals
Start date: 2012-10-18; Completion date: 2018-09-18
Enrollment: 219 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor

Detailed description:

Arms: arm 1: Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks. arm 2: Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks arm 3: Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
Interventions: intervention 1: Secukinumab (75 mg) intervention 2: Placebo intervention 3: Secukinumab (150 mg)
Intervention descriptions: intervention 1: Secukinumab 75 mg s.c. intervention 2: Placebo intervention 3: Secukinumab 150 mg s.c.

Protocol documents:
Clinical trial NCT00628251
Conditions: Ovarian Neoplasms
Keywords: Advanced ovarian cancer BRCA1 protein BRCA2 protein Poly(ADP ribose) polymerases
Sponsor: AstraZeneca
Start date: 2008-07-30; Completion date: 2018-09-19
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281 against liposomal doxorubicin to see which is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed previous platinum therapy.

Detailed description:

Arms: arm 1: AZD2281 Oral 200 mg BID arm 2: Liposomal Doxorubicin arm 3: AZD2281 Oral 400 mg BID
Interventions: intervention 1: AZD2281 intervention 2: Liposomal Doxorubicin intervention 3: AZD2281
Intervention descriptions: intervention 1: 400mg Oral twice daily intervention 2: 50mg/m2 Monthly Intravenous intervention 3: 200mg oral twice daily

Protocol documents:
Clinical trial NCT01345253
Conditions: Systemic Lupus Erythematosus
Keywords: SLEDAI Asia placebo BLys PGA BILAG systemic lupus erythematosus SELENA Lupus SRI efficacy B cell SLE Flare Index belimumab safety phase III B lymphocyte
Sponsor: GlaxoSmithKline
Start date: 2011-05-23; Completion date: 2018-09-21
Enrollment: 709 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus erythematosus (SLE) over a 52 week period.

Detailed description:
The purpose of this study is to demonstrate the efficacy and safety of belimumab 10mg/kg administered intravenously (IV) every 4 weeks compared to placebo, in patients with SLE when added to standard of care therapy, as measured by the SLE Responder Index (SRI) at 52 weeks, defined by a composite endpoint using SELENA SLEDAI score, Physician's Global Assessment (PGA) and BILAG A and B organ domain scores.

Arms: arm 1: 10mg/kg arm 2: placebo
Interventions: intervention 1: Belimumab intervention 2: Placebo
Intervention descriptions: intervention 1: 10mg/kg administered intravenously. Dosing at Weeks 0, 2, and 4, then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study. intervention 2: Administered intravenously. Dosing at Weeks 0, 2, and 4, and then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.

Protocol documents:
Clinical trial NCT01544491
Conditions: Prevention of Acute Rejection in Paediatric Recipients of a Renal Transplant
Keywords: Paediatric kidney transplantation Early MMF to everolimus conversion Composite efficacy (biopsy-proven acute rejection, graft loss or death) Renal function
Sponsor: Novartis Pharmaceuticals
Start date: 2012-08-17; Completion date: 2018-09-24
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if everolimus combined with reduced exposure CNI (TAC) is efficacious and safe and will support corticosteroid elimination compared to a standard exposure CNI (TAC) + MMF + steroid regimen after paediatric kidney transplantation. An additional purpose of the study is to assess the effect of the combination of EVR and reduced exposure CNI (TAC) on renal function.

This study is part of the requirements of the Paediatric Investigational Plan approved by Paediatric Committee at the European Medicines Agency (PDCO/EMA) on September 10, 2010, and is intended to support the indication of everolimus in the prevention of acute rejection in paediatric recipients of a renal transplant.

Detailed description:

Arms: arm 1: Conversion from MMF to everolimus plus reduced dose tacrolimus and steroids withdrawal at 6 months after transplant arm 2: MMF continuation (in combination with tacrolimus and standard dose steroids)
Interventions: intervention 1: RAD001 intervention 2: MMF
Intervention descriptions: intervention 1: Everolimus (C0 trough level of 3-8 ng/mL) in combination with reduced dose tacrolimus and steroids withdrawal at 6 months after transplant intervention 2: MMF (Cellcept®): 600mg/m2/dose twice daily (1200 mg/m2/day) in combination with tacrolimus (Prograf) and standard dose steroids

Protocol documents:
Clinical trial NCT02924064
Conditions: Type 2 Diabetes Mellitus
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2016-09-01; Completion date: 2018-09-25
Enrollment: 247 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
This study is designed as a prospective, multi-centre, parallel group, double-blind randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of MP-513 (Teneligliptin) in combination with metformin.

Detailed description:

Arms: arm 1: Teneligliptin (20mg once daily) for 24 weeks in combination with metformin arm 2: Placebo for 24 weeks in combination with metformin
Interventions: intervention 1: Teneligliptin 20mg intervention 2: Placebo intervention 3: Metformin ≥ 1000 mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Prot_000.pdf: 









































































































SAP_001.pdf: