ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02018887
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-12-01; Completion date: 2015-02-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate how safe LY2969822 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of the study drug. This is the first time that this study drug is being given to participants. This study is for research purposes only and is not intended to treat any medical condition.

Detailed description:
Participants in Part A will complete three study periods, which together will last about 40 days. Participants in Parts B and C will complete one study period which will last about 17 days, but the total study time is about 40 days. Each participant may only enroll in one part. Screening is required within 28 days prior to the start of the study for all participants.

Arms: arm 1: Single dose of LY2969822 administered orally in 2 of 3 study periods. arm 2: Single dose of placebo administered orally in 1 of 3 study periods. arm 3: LY2969822 administered orally for 14 days. arm 4: Placebo administered orally for 14 days. arm 5: LY2969822 administered orally for 14 days. arm 6: Placebo administered orally for 14 days.
Interventions: intervention 1: LY2969822 intervention 2: Placebo
Intervention descriptions: intervention 1: Capsules administered orally intervention 2: Capsules administered orally

Protocol documents:
Clinical trial NCT02020616
Conditions: Type 2 Diabetes Mellitus
Sponsor: Eli Lilly and Company
Start date: 2013-12-01; Completion date: 2015-02-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety and effectiveness of the study drug known as LY3053102 in participants with Type 2 diabetes mellitus. The study drug will be given in different doses as an injection under the skin. The study is expected to last up to 6 months for each participant. Participants may remain on stable-dose metformin as prescribed by their personal physician.

Detailed description:

Arms: arm 1: Stage 1: Escalating dose (7 milligrams \[mg\] up to 200 mg) of LY3053102 administered once a week by subcutaneous (SC) injection for 12 weeks. Stage 2: LY3053102 administered once a week by SC injection for 12 weeks arm 2: Stage 1 and Stage 2: Placebo to match LY3053102 administered by SC injection once a week for 12 weeks arm 3: Stage 1 and Stage 2: Exenatide ER 2 mg given by SC injection once a week for 12 weeks arm 4: Stage 2: LY3053102 administered by SC injection once a week for 12 weeks and exenatide ER 2 mg administered by SC injection once a week for 12 weeks
Interventions: intervention 1: LY3053102 intervention 2: Exenatide ER intervention 3: Placebo intervention 4: Metformin
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered SC intervention 3: Administered SC intervention 4: Administered orally (PO)

Protocol documents:
Clinical trial NCT02034019
Conditions: Post Ocular Surgical Inflammation and Pain
Sponsor: Ocular Therapeutix, Inc.
Start date: 2014-02-01; Completion date: 2015-02-01
Enrollment: 247 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.

Detailed description:

Arms: arm 1: Resorbable hydrogel drug delivery vehicle containing dexamethasone arm 2: Resorbable hydrogel drug delivery vehicle containing no drug
Interventions: intervention 1: Dexamethasone intervention 2: Punctum Plug
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02039115
Conditions: Esophageal Stenosis
Sponsor: AdventHealth
Start date: 2014-03-01; Completion date: 2015-02-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Complete endoscopic resection of early neoplastic Barrett's Esophagus (BE) is a curative procedure. However, a significant proportion of patients develop symptomatic esophageal strictures following Complete Barrett's Eradication (CBE), and this limits the technique, particularly for circumferential and longer segment disease. Oral steroid therapy may reduce stricture formation; thereby allowing CBE to be performed with minimal associated morbidity.

Detailed description:
The main objective of the proposed randomized trial is to compare the rate of symptomatic oesophageal strictures in patients receiving placebo versus oral prednisone.

Arms: arm 1: Daily oral prednisone is taken for 6 weeks, at a dose of 40mg/day in week 1, 30mg/day in week 2, 20mg/day week 3 and 4, 10mg/day in week 5, and 5mg/day in week 6. Prednisone is taken in the morning. Treatment commences the day of the procedure, with the dose taken with a sip of water prior to discharge. The 6-week treatment regimen is given after both the 1st and 2nd stage complete Barretts excision. arm 2: Placebo tablets will be taken in the same manner as the prednisone arm.
Interventions: intervention 1: prednisone intervention 2: placebo
Intervention descriptions: intervention 1: 6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision. intervention 2: 6 weeks of placebo therapy will be given in the same manner as the prednisone arm after the first and second stage complete Barretts excision.

Protocol documents:
Clinical trial NCT02050334
Conditions: Healthy
Keywords: Phase 1 Healthy Volunteer Safety Healthy Volunteer Safety Study
Sponsor: Chemigen, LLC
Start date: 2013-11-01; Completion date: 2015-02-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if CC100, given by mouth, is safe and is tolerated in increasing doses. How long the drug remains in the body will also be calculated.

Detailed description:
Approximately 18 healthy subjects will be randomized to receive by mouth either 3 single increasing doses of CC100 or 1 dose of placebo and 2 increasing doses of CC100. Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. Subjects are required to stay in the Clinic for approximately 24 hours following each dose. Subjects may choose to have an optional lumbar puncture following the 3rd dose of study drug.

Arms: arm 1: CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. arm 2: CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
Interventions: intervention 1: CC100 intervention 2: Placebo
Intervention descriptions: intervention 1: CC100 reconstituted in diluent intervention 2: Diluent. Amount to match CC100 dose.

Protocol documents:
Clinical trial NCT02059902
Conditions: Thermal Burns
Keywords: Pain management Narcotic consumption Skin graft
Sponsor: HealthPartners Institute
Start date: 2012-09-01; Completion date: 2015-02-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Thermal injury results in one of the most intense and prolonged forms of pain the body can experience. Opioid narcotics are the most powerful drugs for acute and chronic pain, and their use in the perioperative period has been the mainstay of treatment; although medication requirements in burn patients are often underestimated. More medication may not be the answer, as relatively large doses of short acting opioids in the operative theater are associated with greater postoperative opioid consumption and higher pain scores. Furthermore, extensive use of opioids has resulted in the development of by hyperalgesia and allodynia. Lidocaine is an amide local anesthetic that has analgesic, anti-hyperalgesic, antiarrhythmic, and anti-inflammatory properties. Over the past 25 years, systemic lidocaine has been used for perioperative pain management in a variety of surgical procedures. The design of this study will examine if lidocaine will reduce the pain scores and narcotic utilization in patients undergoing surgical procedures for burn injuries. The intervention group will receive a bolus dose of lidocaine followed by a continuous infusion over 24 hours. The control group will get an equal volume of saline. The investigators will compare pain scores, opioid use, and narcotic equivalents based on body weight and burn surface area (BSA) grafted.

Detailed description:

Arms: arm 1: Normal saline (bolus followed by continuous infusion) arm 2: Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)
Interventions: intervention 1: Lidocaine intervention 2: Placebo
Intervention descriptions: intervention 1: Lidocaine infusion runs for a total of 24 hours intervention 2: Normal saline runs for a total of 24 hours

Protocol documents:
Clinical trial NCT02068443
Conditions: Type 2 Diabetes Mellitus
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2014-02-01; Completion date: 2015-02-01
Enrollment: 374 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the efficacy and safety of 24-week treatment with metformin hydrochloride 500 mg once daily added on to alogliptin (SYR-322) 25 mg in type 2 diabetic patients with inadequate glycemic control despite treatment with alogliptin 25 mg in addition to diet and exercise therapy.

Detailed description:
The drugs being tested in this study are called alogliptin and metformin hydrochloride. Alogliptin in combination with metformin hydrochloride was being tested to treat people who have Type 2 diabetes mellitus (T2DM) with inadequate glycemic control despite treatment with alogliptin in addition to diet and exercise. This study looked at the efficacy and safety of alogliptin 25 mg once daily (QD) + metformin hydrochloride 500 mg QD compared to alogliptin 25 mg QD + metformin hydrochloride 250 mg twice daily (BID) and alogliptin 25 mg QD administered alone.

The study enrolled 374 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

* Alogliptin 25 mg QD + metformin hydrochloride 500 mg QD
* Alogliptin 25 mg QD + metformin hydrochloride 250 mg BID
* Alogliptin 25 mg QD

This multi-center trial was conducted in Japan. The overall time to participate in this study was 36 weeks (12-week screening period and 24-week treatment period). Participants made multiple visits to the clinic including a final visit 24 weeks after the start of study medication.

Arms: arm 1: Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks. arm 2: Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, once, daily, after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks. arm 3: Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
Interventions: intervention 1: Alogliptin intervention 2: Metformin hydrochloride intervention 3: Metformin hydrochloride Placebo
Intervention descriptions: intervention 1: Alogliptin tablets intervention 2: Metformin hydrochloride tablets intervention 3: Metformin hydrochloride placebo-matching tablets

Protocol documents:
Clinical trial NCT02081079
Conditions: Chronic Genotype 4 HCV Chronic Genotype 5 HCV
Keywords: HCV GT 4 HCV GT 5
Sponsor: Gilead Sciences
Start date: 2014-03-01; Completion date: 2015-02-01
Enrollment: 85 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.

Detailed description:

Arms: arm 1: LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 4 hepatitis C virus (HCV) infection arm 2: LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 5 hepatitis C virus (HCV) infection
Interventions: intervention 1: LDV/SOF
Intervention descriptions: intervention 1: LDV/SOF (90/400 mg) FDC tablet administered orally once daily

Protocol documents:
Clinical trial NCT02091752
Conditions: Primary Myelofibrosis
Keywords: Primary Myelofibrosis Hematologic Diseases Myeloproliferative Disorders INC424 Ruxolitinib
Sponsor: Novartis Pharmaceuticals
Start date: 2014-09-01; Completion date: 2015-02-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of the study is to assess the efficacy and safety of restarting ruxolitinib after treatment interruption due to loss of response and/or adverse events.

Detailed description:

Arms: arm 1: All participants received ruxolitinib.
Interventions: intervention 1: Ruxolitinib
Intervention descriptions: intervention 1: Starting dose was based on reason for previous discontinuation of ruxolitinib (i.e. loss of response or AE) and baseline platelet count. For participants who previously discontinued ruxolitinib due to loss of response, the starting dose was determined based on baseline platelet counts as follows: participants with a baseline platelet count of ≥ 200 x 109/L began dosing at 20 mg po bid; participants with a baseline platelet count of 100 x 109/L to \<200 x 109/L began dosing at 15 mg po bid. Participants who previously discontinued ruxolitinib due to an AE initiated therapy at a total daily dose 5 mg lower than the total daily dose prior to discontinuation.

Protocol documents:
Clinical trial NCT02126839
Conditions: Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2014-05-01; Completion date: 2015-02-01
Enrollment: 186 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is to evaluate the chronic-dose efficacy and the safety of Albuterol MDPI compared to placebo in pediatric participants with asthma.

Detailed description:

Arms: arm 1: Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks. arm 2: Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
Interventions: intervention 1: Albuterol MDPI intervention 2: Placebo intervention 3: ProAir HFA inhaler
Intervention descriptions: intervention 1: 90 mcg/actuation of the multidose dry powder inhaler (MDPI). intervention 2: Matching Placebo delivered via a multidose dry powder inhaler (MDPI). intervention 3: Rescue medication, ProAir hydrofluoroalkane (HFA) inhaler, was dispensed at the run-in visit for the relief of asthma symptoms to be administered as needed.

Protocol documents:
Clinical trial NCT02132936
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2014-06-01; Completion date: 2015-02-01
Enrollment: 504 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis vulgaris

Detailed description:

Arms: arm 1: LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks arm 2: Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks arm 3: Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks arm 4: Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks
Interventions: intervention 1: LEO 90100 aerosol foam intervention 2: Aerosol foam vehicle intervention 3: Calcipotriol BDP gel intervention 4: Gel vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02147691
Conditions: Acne Rosacea
Sponsor: Derm Research, PLLC
Start date: 2014-05-01; Completion date: 2015-02-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The pilot study will investigate whether combination treatment of Finacea 15% Gel and Brimonidine 0.33% Gel could be more effective than Brimonidine 0.33% Gel monotherapy in treating both the papules/pustules and erythema associated with rosacea.

Detailed description:
Acne rosacea is a chronic inflammatory disease with different components including inflammatory lesions (papules/pustules), erythema and telangiectasia. Brimonidine 0.33% Gel primarily affects the erythematous components of rosacea. As such, combination treatment with a standard rosacea treatment, such as Finacea 15% Gel, may provide additional relief for the inflammatory component of rosacea.

Arms: arm 1: Azelaic acid 15% to the face each AM followed 30 minutes later by Brimonidine 0.33%

Azelaic acid 15% to the face each PM arm 2: Brimonidine 0.33% Gel
Interventions: intervention 1: Azelaic acid 15% intervention 2: Brimonidine 0.33%
Intervention descriptions: intervention 1: Applied to the face each AM and PM intervention 2: Applied to the face each AM 30 minutes after the application of Azelaic acid 15%

Protocol documents:
Clinical trial NCT02178540
Conditions: Cystic Fibrosis
Keywords: Human factors, TOBI® Podhaler™, Instructions For use, IFU, CF patients
Sponsor: Novartis Pharmaceuticals
Start date: 2014-08-01; Completion date: 2015-02-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this actual use human factors (HF) study is to validate the approved US TOBI Podhaler Instructions for Use (IFU), by establishing that the IFU effectively communicates the information necessary to achieve safe and effective use of the Podhaler device.

Detailed description:
The objective of the HF study is to determine whether cystic fibrosis patients in the US, representative of potential TOBI Podhaler users, can understand and follow the approved IFU and the extent to which the approved IFU supports safe and effective use of the Podhaler device.

This study is an 'actual use' study, in that patients will inhale the contents of placebo capsules through the Podhaler device.

Due to the use of placebo capsules, the study is considered a clinical study and will be conducted accordingly. The study is therefore a human factors observational use study conducted within a clinical study. It is an open label, unblinded, non-randomized study and consists of two visits. At visit 2 patients who are eligible will participate in a human factor assessment to determine whether or not a patient understands the IFU content and can demonstrate safe and effective use of the Podhaler device.

Arms: arm 1: one dose (4 capsules) of placebo
Interventions: intervention 1: Placebo intervention 2: Tobi Podhaler
Intervention descriptions: intervention 1: one dose (4 capsules) of placebo intervention 2: The capsule containing the study medication has to be released from the blister card, be inserted into the Podhaler device, actuated and the study drug be inhaled according to instructions for use

Protocol documents:
Clinical trial NCT02193815
Conditions: Psoriasis Vulgaris
Keywords: psoriasis plaque vulgaris phase 1 randomized double-blind topical safety
Sponsor: Pfizer
Start date: 2014-09-01; Completion date: 2015-02-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a vehicle and comparator controlled Proof of Mechanism (PoM) trial to evaluate the effect on psoriasis disease activity and safety of topically applied PF 06263276 in subjects with psoriasis vulgaris.

Detailed description:

Arms: arm 1: Study treatments 1-6 Study drug, vehicle, Tofacitinib, vehicle, Daivonex solution and ointment
Interventions: intervention 1: PF06263276 intervention 2: Vehicle intervention 3: 2%Tofacitinib Ointment intervention 4: Vehicle intervention 5: Daivonex intervention 6: Daivonex Ointment
Intervention descriptions: intervention 1: 4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD intervention 2: Active ingredient-free vehicle to 4% solution intervention 3: Daily Dosage: approximately 4 mg tofacitinib intervention 4: Active ingredient-free vehicle to 2% Ointment intervention 5: Daivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg intervention 6: Daivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg

Protocol documents:
Clinical trial NCT02226549
Conditions: Hepatitis C Virus Infection
Keywords: hepatitis C Gilead GS-9451
Sponsor: Gilead Sciences
Start date: 2014-07-01; Completion date: 2015-02-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV) ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1 hepatitis C virus (HCV) infection and cirrhosis.

Detailed description:

Arms: arm 1: Participants will receive LDV/SOF+VDV for 8 weeks. arm 2: Participants will receive LDV/SOF+VDV+RBV for 8 weeks.
Interventions: intervention 1: LDV/SOF intervention 2: VDV intervention 3: RBV
Intervention descriptions: intervention 1: LDV/SOF (90/400 mg) FDC tablet administered orally once daily intervention 2: VDV 80 mg tablet administered orally once daily intervention 3: RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents: