ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02691507
Conditions: Atopic Dermatitis
Keywords: Eczema, Itchy Skin
Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
Start date: 2016-02-01; Completion date: 2016-04-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC) 1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD.

Detailed description:
Approximately 60 subjects will be enrolled to ensure 52 subjects complete the study (39 subjects: active treatment and 13 subjects: positive control).

Adults and children (ages 12 and over) will receive either a marketed or not yet marketed investigational product for the treatment of eczema. Subjects will be asked to stop use of prescription and all eczema treatments 2 days before the start of the study and during the study. Subjects will apply study product as indicated for 7 days to affected areas.

Subjects will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the eczema and symptoms. Skin moisture levels will also be tested.

Arms: arm 1: Marketed - EpiCeram(R) Skin Barrier Emulsion: Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin. arm 2: Not Yet Marketed - 1% Colloidal Oatmeal Balm: Apply at least once per night or more if needed.
Interventions: intervention 1: EpiCeram Skin Barrier Emulsion intervention 2: Experimental Product 1% Colloidal Oatmeal Balm
Intervention descriptions: intervention 1: EpiCeram Skin Barrier Emulsion intervention 2: Experimental Product 1% Colloidal Oatmeal Balm

Protocol documents:
Clinical trial NCT02708355
Conditions: Heartburn
Sponsor: Pfizer
Start date: 2016-01-01; Completion date: 2016-04-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot study is to investigate the association between gastric acid suppression and relief of 24 hour heartburn following treatment with the proton pump inhibitor (PPI) drug esomeprazole in frequent heartburn patients.

Detailed description:

Arms: arm 1: Esomeprazole 20 mg administered orally in the morning and placebo administered orally in the evening arm 2: Esomeprazole 20 mg administered orally in the morning and esomeprazole 20 mg administered orally in the evening arm 3: Placebo administered orally in the morning and placebo administered orally in the evening
Interventions: intervention 1: Esomeprazole 20 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate) intervention 2: Placebo capsules

Protocol documents:
Clinical trial NCT02720224
Conditions: Contraception Menopause
Sponsor: Estetra
Start date: 2016-02-01; Completion date: 2016-04-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being conducted to further understand the elimination pathways, metabolite profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol (\[14C\] estetrol).

Detailed description:
This will be an open-label, non-randomised, single dose study in healthy female volunteers of non-child bearing potential.

Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. The study will be executed in a single group, 6 subjects will be enrolled and dosed with a single oral dose of carbon 14 labelled estetrol. Subjects will be admitted to the clinical unit on the morning prior to study drug administration (Day -1). Dosing will take place on the morning of Day 1 after an overnight fast (approximately 10 h).

Subjects will be resident in the clinic up to 240 h after dosing during which plasma, blood, urine and faeces samples will be collected. It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of \>90% or if a mean of \<1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 h periods. In this case, collection of all samples (blood, urine and faeces) will be stopped and the subjects will undergo discharge assessments. If this criterion has not been met by all subjects on Day 11, home collections of urine and faeces may be requested at the discretion of the investigator for individual subjects.

Arms: arm 1: A single oral dose of 15 mg carbon 14 labelled estetrol (\[14C\]-estetrol), containing approximately 2.8 MBq (76 µCi) 14C
Interventions: intervention 1: Estetrol
Intervention descriptions: intervention 1: 15 mg \[14C\]-estetrol containing approximately 2.8 MBq (76 μCi) 14C

Protocol documents:
Clinical trial NCT02767128
Conditions: Iron-refractory, Iron-deficiency Anemia (IRIDA)
Keywords: pharmacokinetics healthy adult volunteer
Sponsor: Rockwell Medical Technologies, Inc.
Start date: 2016-04-01; Completion date: 2016-04-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered orally in healthy adult volunteers. It is a randomized multiple treatments, single dose study.

Detailed description:
This is a Phase 1/2, randomized multiple treatments, single dose study assessing the pharmacokinetics (PK) and absolute bioavailability of Fer-In-Sol ( Ferrous Sulfate) and Triferic (ferric pyrophosphate citrate, or FPC) administered orally with Shohl's solution in healthy volunteers.

Total participation in the study is approximately six weeks and is comprised of a screening visit, 6 treatment periods, and a follow-up visit.

The study will be conducted over a 13 day period:

Day 1 will used to determine the baseline serum iron profile for each subject.

Each subject will subsequently receive in a randomized sequence between Day 2 and 10:

1. A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw).
2. A single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed after 10 minutes by Fer-In-Sol at 3 mg Fe/kg bw
3. a single oral dose of Triferic PO at 3 mg Fe/kg bw
4. a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) administered 10 minutes prior to a single oral dose of Triferic at 3 mg Fe/kg bw.
5. a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed immediately by a single oral dose of Triferic at 3 mg Fe/kg bw.

All subjects will receive a single dose of 6.6 mg Triferic as a 4 hour IV infusion (to mimic the 4 hour iron tolerance test) on Day 12.

Blood samples will be obtained at various times to analyze for serum iron parameters and for safety.

Arms: arm 1: Patients will receive A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw). arm 2: Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7ml/kg bw) followed after 10 minutes by Fer-In-Sol at 3 mg Fe/kg bw. arm 3: Patients will receive a single oral dose of Triferic at 3 mg Fe/kg bw. arm 4: Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) administered 10 minutes prior to a single oral dose of Triferic at 3 mg Fe/kg bw. arm 5: Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed immediately by a single oral dose of Triferic at 3 mg Fe/kg bw. arm 6: Patients will receive IV Triferic iron 6.6 mg diluted in an appropriate amount of D5W administered as a 120 mL infusion intravenously for 4 hours. arm 7: baseline serum iron profile will be determined for each patient. no study drug will be administered.
Interventions: intervention 1: Triferic intervention 2: Fer-In-Sol intervention 3: Shohl's solution
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02787057
Conditions: Peritoneal Dialysis Associated Peritonitis
Sponsor: Peking University First Hospital
Start date: 2012-11-01; Completion date: 2016-04-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Intra-peritoneal administration of antibiotics covering both gram-positive and gram-negative organisms was recommended as first-line regimen for the management of peritoneal dialysis related peritonitis. Oral administration of quinolones can also achieve effective serum concentrations, and is more convenient and economical. We conducted a pilot randomized controlled study to compare the effects on peritonitis cure and relapsing rates between oral moxifloxacin plus IP vancomycin and conventional IP vancomycin plus ceftazidime.

Detailed description:
To compare the effects on peritonitis cure and relapsing rates between oral moxifloxacin plus IP vancomycin and conventional IP vancomycin plus ceftazidime, eligible PD patients were randomly assigned to study group (IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD) and control group (IP vancomycin 1g every 5 days combined with IP ceftazidime 1g QD). Patients were followed for 3 months after the completion of the treatment period. Primary endpoint is complete cure, secondary endpoint are primary response and primary or secondary treatment failure.

Arms: arm 1: IP vancomycin 1g every 5 days combined with IP ceftazidime 1g QD. The duration of treatment was based on internatinal society of peritoneal dialysis (ISPD) guideline recommendations. arm 2: IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations.
Interventions: intervention 1: vancomycin intervention 2: moxifloxacin intervention 3: ceftazidime
Intervention descriptions: intervention 1: IP vancomycin 1g every 5 days intervention 2: oral moxifloxacin 400mg QD intervention 3: IP ceftazidime 1g QD

Protocol documents:
Clinical trial NCT01314105
Conditions: Ovarian Neoplasms Peritoneal Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2011-03-15; Completion date: 2016-04-04
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This phase I, open label dose escalation study will investigate the addition of BIBF 1120 to treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer.

Detailed description:

Arms: arm 1: BIBF 1120 (100 mg twice daily (BID)) + Carboplatin (Area Under the Curve (AUC) 5 mg/mL\*min) + PLD (30 mg/m2) arm 2: BIBF 1120 (150 mg twice daily (BID)) + Carboplatin (Area Under the Curve (AUC) 5 mg/mL\*min) + PLD (30 mg/m2) arm 3: BIBF 1120 (200 mg twice daily (BID)) + Carboplatin (Area Under the Curve (AUC) 5 mg/mL\*min) + PLD (30 mg/m2)
Interventions: intervention 1: BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min intervention 2: BIBF 1120+ PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min intervention 3: BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
Intervention descriptions: intervention 1: BIBF1120 twice daily along with standard therapy of PLD + carboplatin intervention 2: BIBF1120 twice daily along with standard therapy of PLD + carboplatin intervention 3: BIBF1120 twice daily along with standard therapy of PLD + carboplatin

Protocol documents:
Clinical trial NCT01690299
Conditions: Psoriasis Psoriatic Arthritis
Keywords: Psoriasis arthritis psoriatic palmoplantar scalp psoriasis pill psoriasis tablet plaque psoriasis plaque type psoriasis moderate to severe plaque type psoriasis psoriatic arthritis
Sponsor: Amgen
Start date: 2012-10-01; Completion date: 2016-04-04
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.

Detailed description:
This is a phase 3b, multicenter, randomized, placebo-controlled, double-blind, double-dummy, study of the efficacy and safety of apremilast, etanercept, and placebo, in adults with moderate to severe plaque psoriasis.

250 participants will be randomized 1:1:1 to the three treatment groups. All subjects will receive both tablets and injections through Week 16.

The study will consist of four phases:

* Screening Phase - up to 35 days
* Double-blind Placebo-controlled Phase - Weeks 0-16
* Apremilast Extension Phase - Weeks 16-104
* Post-treatment Observational Follow-up Phase

During the double-blind, placebo-controlled phase, subjects will receive treatment with one of the following:

* apremilast (APR) 30 mg tablets orally twice a day (BID) plus once weekly (QW) evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections (1 mL x 2 injections SC), or
* etanercept (ETN) 50 mg evaluator/subject-blinded subcutaneous (SC) once weekly (QW) injections (2 x 25 mg) plus placebo tablets orally twice a day (BID), or
* placebo tablets and evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections.

All subjects will be asked to participate in a 4-week Post-treatment Observational Follow-up Phase either upon completion of the study or upon discontinuation of investigational product for those subjects who terminate the study early.

Arms: arm 1: Apremilast 30 mg tablets orally twice a day (BID) plus once weekly (QW) evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections arm 2: Etanercept 50 mg evaluator/subject-blinded SC QW injections plus placebo tablets orally BID arm 3: Identically matching placebo tablets and evaluator/subject-blinded SC injections
Interventions: intervention 1: Apremilast intervention 2: Etanercept intervention 3: Placebo tablet intervention 4: Placebo injection
Intervention descriptions: intervention 1: Apremilast 30 mg tablet orally BID intervention 2: Etanercept 50 mg evaluator/subject-blinded SC QW injection intervention 3: Placebo tablets BID intervention 4: Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC)

Protocol documents:
Clinical trial NCT02238483
Conditions: Chronic Obstructive Pulmonary Disease COPD
Keywords: Chronic Obstructive Pulmonary Disease COPD patients Exacerbations ICS LABA
Sponsor: AstraZeneca
Start date: 2014-10-28; Completion date: 2016-04-04
Enrollment: 213 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether AZD7624 can reduce acute Chronic Obstructive Pulmonary Disease (COPD) exacerbations in patients on COPD maintenance therapy with a history of frequent acute exacerbations.

Detailed description:

Arms: arm 1: Active treatment arm 2: Placebo Comparator
Interventions: intervention 1: AZD7624 1.0 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Inhaled AZD7624 solution, 11 mg/mL intervention 2: Inhaled placebo solution

Protocol documents:
Clinical trial NCT02470403
Conditions: Elevated Body Mass Index
Keywords: dysglycemic, normoglycemic, prediabetes, type 2 diabetes mellitus
Sponsor: Novartis Pharmaceuticals
Start date: 2015-06-05; Completion date: 2016-04-04
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and normoglycemic patients with elevated body mass index (BMI)

Detailed description:

Arms: arm 1: LIK066 150 mg qd within 15 minutes before starting lunch arm 2: Matching placebo tablets of LCZ696 150 mg within 15 minutes before starting lunch. arm 3: LIK066 75 mg bid before breakfast and dinner arm 4: LIK066 50 mg tid before all 3 meals; arm 5: Matching placebo tablets tid before meals.
Interventions: intervention 1: LIK066 intervention 2: Placebo
Intervention descriptions: intervention 1: LIK066 25 mg tablets intervention 2: Matching placebo tablets

Protocol documents:
Clinical trial NCT02635750
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2016-01-15; Completion date: 2016-04-04
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Part I:

To investigate whether and to what extent donepezil affects single dose pharmacokinetics of BI 409306

Part II:

To investigate whether and to what extent BI 409306 affects the single dose pharmacokinetics of donepezil

Detailed description:

Arms: arm 1: Subjects received treatment in a fixed sequence. First BI 409306 as reference treatment (R1)), then BI 409306 + donepezil as test treatment (T1)). arm 2: Subjects received first the reference treatment (R2) followed by a washout period, followed by the test treatment (T2). arm 3: Subjects received first the test treatment 2 (T2) followed by a washout period, followed by the reference treatment 2 (R2)).
Interventions: intervention 1: BI 409306 intervention 2: Donepezil
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01777269
Conditions: Prostatic Hyperplasia
Sponsor: GlaxoSmithKline
Start date: 2013-02-18; Completion date: 2016-04-05
Enrollment: 489 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an European double-blind, placebo controlled parallel group comparison of DUODART (fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg, one capsule daily) and placebo.

PRIMARY OBJECTIVE:

To assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH who are treated with DUODART, compared to men treated with placebo .

Detailed description:
This is an European double-blind, placebo controlled parallel group comparison of DUODART (fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg, one capsule daily) and placebo. Men eligible at screening will be randomised, after a 4 week placebo run-in, to the 2 treatment groups in a 1:1 ratio. All men will receive standardised lifestyle advice (primarily concerning weight management and exercise) relevant to maintaining sexual function. Men will also receive a standardised lifestyle advice leaflet for BPH. The double blind phase will continue for 12 months, with assessment visits at 2 weeks and at months 1, 3, 6, 9 and a final visit at month 12. Subjects with sexual adverse events during the double blind phase will continue to be followed at scheduled study visits until resolution of the adverse event or at a visit 6 months after the last dose of study medication, whichever is sooner.

PRIMARY OBJECTIVE:

To assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH (international prostate symptom score - IPSS = or \> 12) who are treated with DUODART, compared to men treated with placebo . Change in sexual function will be assessed by change in total score from the full men's sexual health questionnaire (MSHQ) which has domains for erectile dysfunction, ejaculatory function and libido.

Arms: arm 1: Fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg. A capsule once daily during 12 months arm 2: A capsule once daily during 12 months
Interventions: intervention 1: Dutasteride plus tamsulosin intervention 2: Placebo
Intervention descriptions: intervention 1: Take 1 capsule daily intervention 2: Take one capsule daily

Protocol documents:
Clinical trial NCT02168777
Conditions: Neoplasms
Keywords: Patients with Cancer
Sponsor: Bayer
Start date: 2014-06-23; Completion date: 2016-04-05
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase I: Determine the maximum tolerated dose of combination of Regorafenib with Refametinib through a dose escalation study, all tumor types that meet certain inclusion/exclusion criteria can be entered.

After the recommended dose is determined, the Phase II portion of the study will evaluate tolerability and efficacy of the combination treatment in patients with breast cancer, lung cancer, or colorectal cancer, respectively.

Detailed description:
Number of treatment-emergent Adverse Events (AEs) will be reported in Adverse Events section.

Study was originally designed with both Phase I and Phase II part, but sponsor decided not to conduct Phase 2 part due to strategic portfolio re-prioritization.

Arms: arm 1: Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort 0: Refametinib 30mg twice daily (b.i.d) + Regorafenib 80mg once daily (q.d), 3 weeks on/1 week off. arm 2: Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1: Refametinib 20mg b.i.d + Regorafenib 80mg q.d, 3 weeks on/1 week off. arm 3: Phase 1b part of study: Participants received different doses of Refametinib and Regorafenib combination therapy to determine recommended Phase 2 dose (RP2D) via dose-escalation. Cohort -1a: Refametinib 20mg b.i.d + Regorafenib 120mg q.d, 3 weeks on/1 week off.
Interventions: intervention 1: Refametinib (BAY86-9766) intervention 2: Regorafenib (Stivarga, BAY73-4506)
Intervention descriptions: intervention 1: Refametinib twice daily (b.i.d.) in combination with intermittent regorafenib once daily (q.d.) at the assigned dose level.

In Phase 2, the recommended Phase 2 dose (RP2D) for refametinib-regorafenib combination therapy will be used. intervention 2: Refametinib twice daily (b.i.d.) in combination with intermittent regorafenib once daily (q.d.) at the assigned dose level.

In Phase 1b dose escalation, regorafenib will be administered in a 3-weeks-on / 1-week-off schedule except in one cohort, that uses regorafenib 2 weeks on / 2 weeks off regimen (dose level -2). In Phase 2, the recommended Phase 2 dose (RP2D) for refametinib-regorafenib combination therapy will be used.

Protocol documents:
Clinical trial NCT02698566
Conditions: Macular Edema
Sponsor: Genentech, Inc.
Start date: 2016-03-21; Completion date: 2016-04-05
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter study designed to evaluate usability of ranibizumab PFS in patients with neovascular age related macular degeneration or macular edema secondary to retinal vein occlusion.

Detailed description:
The purpose of this study is to assess the ability of HCPs to follow the instructions for use (IFU) to prepare and administer a ranibizumab PFS ITV injection dose to patients.

Arms: arm 1: Healthcare professionals (HCPs) will administer ITV injections of ranibizumab 0.5 mg delivered via PFS to enrolled patients (1 injection to each patient) on Day 1.
Interventions: intervention 1: Ranibizumab
Intervention descriptions: intervention 1: Patients will receive single ITV injection of ranibizumab 0.5 mg delivered via PFS on Day 1.

Protocol documents: