ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02595437
Conditions: End Stage Renal Disease
Keywords: dialysis pediatric chronic kidney disease
Sponsor: Rockwell Medical Technologies, Inc.
Start date: 2015-11-01; Completion date: 2017-01-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, two-period sequential dosing study.

Detailed description:
This is a Phase 1/2, open-label, 2-period, single-dose study assessing the safety and pharmacokinetics (PK) of Triferic (ferric pyrophosphate citrate, or FPC) administered via dialysate and IV to pediatric patients (\< 18 years of age) receiving chronic hemodialysis (CKD-5HD).

Total participation in the study is approximately three weeks and is comprised of a screening visit, two dosing (PK) visits, and a follow-up visit.

Each patient will receive a single dose of Triferic administered IV into the venous blood return line over the duration of the dialysis. At the next scheduled dialysis session each patient will receive a single dose of Triferic administered via dialysate during a single hemodialysis session.

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

Arms: arm 1: On study Day 1, patients will receive IV Triferic iron 0.07 mg/kg diluted in an appropriate amount of D5W administered as a 100 mL infusion into the venous return port of the blood lines during the time the patient is receiving dialysis.The rate of administration will be calculated as such that the entire amount will be administered over the course of the dialysis treatment. On study Day 3, Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic via the hemodialysate over the course of the dialysis treatment.
Interventions: intervention 1: Triferic
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02604017
Conditions: Chronic Hepatitis C Hepatitis C Virus HCV
Keywords: HCV GT1 Non-cirrhotic RBV Free Without cirrhosis Chronic Hepatitis C Hepatitis C Genotype 1 (GT1) IFN free Hepatitis C Ribavirin Free Interferon (IFN) Free HCV Hepatitis C virus DAA
Sponsor: AbbVie
Start date: 2015-10-01; Completion date: 2017-01-01
Enrollment: 703 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with Genotype 1 hepatitis C virus infection without cirrhosis

Detailed description:

Arms: arm 1: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. arm 2: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Interventions: intervention 1: ABT-493/ABT-530
Intervention descriptions: intervention 1: Tablet; ABT-493 coformulated with ABT-530

Protocol documents:
Clinical trial NCT02636595
Conditions: Hepatitis C Virus
Keywords: Hepatitis C Genotype 4 Hepatitis C Chronic Hepatitis C Hepatitis C Genotype 6 Hepatitis C Genotype 5
Sponsor: AbbVie
Start date: 2015-11-01; Completion date: 2017-01-01
Enrollment: 121 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effect of response to treatment by evaluating the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12 weeks of treatment with ABT-493/ABT-530 and to evaluate the safety of the regimen in participants with chronic hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.

Detailed description:

Arms: arm 1: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Interventions: intervention 1: ABT-493/ABT-530
Intervention descriptions: intervention 1: Tablet; ABT-493 coformulated with ABT-530

Protocol documents:
Clinical trial NCT02639052
Conditions: Pruritus
Keywords: Itch Botox Healthy Volunteers
Sponsor: Temple University
Start date: 2016-02-01; Completion date: 2017-01-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if Botox is effective in the treatment of an experimentally induced itch that mimics chronic itch in healthy volunteers.

Detailed description:
Several studies have shown that botulinum toxin type A (BoNT/A) has an antipruritic effect due to the inhibition of acetylcholine and other pruritic factors, such as substance P and glutamate. For instance, subcutaneous BoNT/A improves itch accompanied to hand eczema, dermatitis, lichen simplex, and rhinitis. Furthermore, a double-blind, placebo-controlled study showed that BoNT/A reduced histamine itch intensity in healthy men. Since acetylcholine has been shown to mediate itch in atopic dermatitis, this study aims to test the itch relieving effect of BoNT/A on a non-histaminergic model for chronic itch. This non-histaminergic model using the plant cowhage induces itch by activating protease activated receptor 2 (PAR2) receptors, which play a role in the itch of atopic dermatitis, also making this model better suited to test the efficacy of BoNT/A to relive chronic itch.

Arms: arm 1: 10 units of Botox intradermally injected into one forearm. The subject is blinded to which forearm receives the Botox and which forearm receives the saline vehicle. arm 2: Saline vehicle intradermally injected into the other forearm. The subject is blinded to which forearm receives the Botox and which forearm receives the saline vehicle.
Interventions: intervention 1: Botox intervention 2: Saline
Intervention descriptions: intervention 1: 10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit. intervention 2: 10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit.

Protocol documents:
Clinical trial NCT02646566
Conditions: Postoperative Nausea and Vomiting
Sponsor: Acacia Pharma Ltd
Start date: 2016-03-01; Completion date: 2017-01-01
Enrollment: 705 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless, dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established PONV, in patients who have had prior PONV prophylaxis.

Detailed description:

Arms: arm 1: Single (standard) dose IV APD421 arm 2: Single (high) dose IV APD421 arm 3: Single IV placebo
Interventions: intervention 1: APD421 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02651194
Conditions: Chronic Hepatitis C Virus (HCV) Infection
Keywords: Treatment-naïve HCV Gentoype 2 Non-cirrhotic Chronic Hepatitis C HCV Gentoype 5 HCV Gentoype 4 HCV Gentoype 6 HCV Gentoype 1 Compensated cirrhotic Treatment-experienced HCV Gentoype 3
Sponsor: AbbVie
Start date: 2015-12-01; Completion date: 2017-01-01
Enrollment: 104 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype 1 - 6 infection and chronic severe renal impairment.

Detailed description:

Arms: arm 1: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Interventions: intervention 1: ABT-493/ABT-530
Intervention descriptions: intervention 1: Tablet; ABT-493 coformulated with ABT-530

Protocol documents:
Clinical trial NCT02668185
Conditions: Menopausal Flushing
Keywords: Menopausal flushing
Sponsor: Imperial College London
Start date: 2016-02-01; Completion date: 2017-01-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Placebo-controlled, double-blinded, cross-over clinical trial of a new investigational product

Detailed description:
Double-blinded, placebo-controlled, 2-way crossover study in 30 menopausal women with untreated hot flushes treated with a neurokinin 3 receptor (NK3R) antagonist

Aims:

To investigate whether an NK3R antagonist can reduce menopausal flushing

Treatment:

4 weeks administration of active drug and placebo in random order

Arms: arm 1: Baseline period - 2 weeks NK3R antagonist - AZD4901 - 40mg bd - 4 weeks Washout period - 2 weeks Matched placebo orally bd - 2 weeks Monitoring period - 2 weeks arm 2: Baseline period - 2 weeks Matched placebo orally bd - 2 weeks Washout period - 2 weeks NK3R antagonist - AZD4901 - 40mg bd - 4 weeks Monitoring period - 2 weeks
Interventions: intervention 1: NK3R antagonist - AZD4901 intervention 2: Placebo
Intervention descriptions: intervention 1: Neurokinin 3 receptor antagonist intervention 2: Placebo

Protocol documents:
Clinical trial NCT02745392
Conditions: Acute Migraine
Keywords: migraine migraine headache acute migraine acute migraine headache
Sponsor: Zosano Pharma Corporation
Start date: 2016-06-01; Completion date: 2017-01-01
Enrollment: 365 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, multi-center, parallel-group study designed to compare the safety and efficacy of a range of doses of ZP-Zolmitriptan intracutaneous microneedle systems to placebo.

Detailed description:
This is a randomized, double-blind, multi-center, parallel group study designed to compare the safety and efficacy of a range of doses of ZP-Zolmitriptan intracutaneous microneedle systems to placebo. Subjects who have consented and meet the entry criteria will be randomized to one of four blinded treatment groups. There will be a screening period of up to 1 week, followed by a run-in period to record migraine activity. The run-in period is to determine eligibility for randomization, and is planned to be 4 weeks in duration but may be extended up to an additional 4 weeks to accommodate scheduling. Qualified subjects will randomize to the double-blind treatment period at Day 0 and will have up to 8 weeks to confirm and treat a qualifying migraine. Using the eDiary to confirm they are experiencing a qualified migraine, subjects will self-administer the patch or patches and continue to respond to questions in the eDiary for 48 hours post treatment administration.

Arms: arm 1: ZP-Zolmitriptan 1 mg patch single administration arm 2: ZP-Zolmitriptan 1.9 mg patch single administration arm 3: ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration arm 4: Placebo (either single or double patch) single administration
Interventions: intervention 1: ZP-Zolmitriptan intervention 2: Placebo
Intervention descriptions: intervention 1: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system intervention 2: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)

Protocol documents:
Clinical trial NCT02766517
Conditions: Migraine Disorders
Sponsor: Eli Lilly and Company
Start date: 2016-09-28; Completion date: 2017-01-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study of participants with a diagnosis of migraine who completed another clinical trial NCT02163993. The participants received either LY2951742 or placebo. This study NCT02766517 will evaluate how certain biomarkers may be related to the participant's response in study NCT02163993. The study will last about five days.

Detailed description:

Arms: arm 1: Single topical dose of capsaicin
Interventions: intervention 1: Capsaicin
Intervention descriptions: intervention 1: Administered topically

Protocol documents:
Clinical trial NCT02785172
Conditions: Psoriasis
Sponsor: Bausch Health Americas, Inc.
Start date: 2016-04-01; Completion date: 2017-01-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque Psoriasis

Detailed description:
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque Psoriasis

Arms: arm 1: Lotion arm 2: Cream arm 3: Lotion arm 4: Cream
Interventions: intervention 1: IDP-118 Vehicle Lotion intervention 2: IDP-118 Vehicle Cream intervention 3: IDP-118 Lotion intervention 4: Ultravate Cream
Intervention descriptions: intervention 1: Vehicle intervention 2: Vehicle intervention 3: Lotion intervention 4: Cream

Protocol documents:
Clinical trial NCT02785185
Conditions: Psoriasis
Sponsor: Bausch Health Americas, Inc.
Start date: 2016-06-01; Completion date: 2017-01-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study.

Detailed description:
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-122 Lotion (0.01% halobetasol propionate) to Ultravate® (halobetasol propionate) Cream, 0.05% in the Treatment of Plaque Psoriasis.

Arms: arm 1: Lotion arm 2: Cream arm 3: Lotion arm 4: Cream
Interventions: intervention 1: IDP-122 Vehicle Lotion intervention 2: IDP-122 Vehicle Cream intervention 3: IDP-122 Lotion intervention 4: Ultravate Cream
Intervention descriptions: intervention 1: Vehicle intervention 2: Vehicle intervention 3: Lotion intervention 4: Cream

Protocol documents:
Clinical trial NCT02805907
Conditions: Asthma, Bronchial
Sponsor: MurciaSalud
Start date: 2016-06-01; Completion date: 2017-01-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Introduction: There are many cross-sectional studies in children and adults indicating that low vitamin D levels in asthmatic patients are correlated with poorer asthma control, poorer lung function, decreased response to glucocorticoids and more frequent exacerbations. Moreover, as there is a significant group of asthmatic patients having insufficient control of their disease, despite high doses of inhaled corticosteroids, we have investigated new treatment alternatives, which include vitamin

Objective: To determine the efficacy of vitamin D supplementation in asthmatic patients with vitamin D deficiency in degree of asthma control.

Materials and methods: A prospective, controlled, randomised, triple-blind study was conducted with a follow-up of 6 months. The patients recruited were over 18 years of age with a medical diagnosis of bronchial asthma and serum 25(OH)D3 levels \< 30 ng/ml. Patients were excluded if they had a smoking habit ≥ 10 pack-years, taking vitamin D supplements, kidney disease (creat. \> 2 mg/dl), hypercalcaemia (corrected with proteins \> 10.5 mg/dl), a repeat episodes of renal colic, any gastrointestinal disease that might interfere with vitamin D absorption, or severe psychosocial problems, or were pregnant or breast-feeding. The randomisation process assigned patients to one of two groups: a group that received vitamin D (in the form of calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route) and another group that received placebo in a presentation with an identical appearance and the same administration regimen. Demographic, clinical, spirometry and laboratory endpoints were collected. The primary endpoint was degree of asthma control as determined by the internationally validated Asthma Control Test (ACT). The secondary endpoints were asthma exacerbations, dose of inhaled corticosteroids and quality of life as measured using the Mini-AQLQ (Asthma Quality of Life Questionnaire).

Detailed description:

Arms: arm 1: Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route arm 2: Placebo in a presentation with an identical appearance taken weekly by the oral route
Interventions: intervention 1: Calcifediol intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02815709
Conditions: Acute Pain
Sponsor: Trevena Inc.
Start date: 2016-05-01; Completion date: 2017-01-01
Enrollment: 418 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Oliceridine intervention 2: Placebo intervention 3: Morphine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02820324
Conditions: Acute Pain
Sponsor: Trevena Inc.
Start date: 2016-05-01; Completion date: 2017-01-01
Enrollment: 407 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute pain after abdominoplasty.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Oliceridine intervention 2: Placebo intervention 3: Morphine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02870205
Conditions: Seasonal Allergic Rhinitis (SAR)
Sponsor: Glenmark Specialty S.A.
Start date: 2016-08-01; Completion date: 2017-01-01
Enrollment: 1176 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: GSP 301 NS intervention 2: GOM-NS intervention 3: GMM-2 NS intervention 4: GSP 301 placebo NS
Intervention descriptions: intervention 1: 2 spray in each nostril twice daily for 14 days intervention 2: 2 spray in each nostril twice daily for 14 days intervention 3: 2 spray in each nostril twice daily for 14 days intervention 4: 2 spray in each nostril twice daily for 14 days

Protocol documents:
Clinical trial NCT03002454
Conditions: Cancer of Bone
Keywords: 99mTc Pertechnetate Sodium Pertechnetate Technetium Molybdenum MDP neutron activation
Sponsor: University of Manitoba
Start date: 2016-08-01; Completion date: 2017-01-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A non-fission sourced, solvent generator produced 99mTc intravenous injection, as 99mTc -MDP, is to be used as a bone scan diagnostic radiopharmaceutical for assessment of bone pathology using the same oncologic indications as nuclear reactor sourced 99mTc, as 99mTc-MDP.

Detailed description:
This clinical trial will be a comparison of diagnostic and imaging equivalency of 99mTc Pertechnetate intravenous injection (labeled with commercial MDP kits) produced by a non-fission sourced/solvent generator and a nuclear reactor/column sourced generator. Each oncologic participant acts as their own control to reduce error variance.

Condition Intervention Phase Oncologic indication for which a bone scan would normally be indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo. Drug: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo. Phase 3

Arms: arm 1: Oncologic indication for which a bone scan would normally be indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo. The images of the 99mTc MDP Injection-neutron-bombardment will be compared to the previous (on file) images from the 99mTc MDP Injection-fission
Interventions: intervention 1: 99mTc MDP Injection:neutron-bombardment
Intervention descriptions: intervention 1: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.

Protocol documents:
Clinical trial NCT03019887
Conditions: Schizophrenia Relapse
Sponsor: Juntendo University
Start date: 2011-04-01; Completion date: 2017-01-01
Enrollment: 139 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than 1000mg/day and to evaluate relationship between relapse and cognitive function.

Detailed description:
We attempted to reduce the dose of antipsychotics to ≤1000-mg chlorpromazine eq./day. The dose was gradually reduced at a rate of ≤50-mg chlorpromazine eq./week, and the reduction was discontinued if the subjects relapsed. The differences in baseline cognitive function were analyzed between the patients with no relapse and relapse groups.

Arms: arm 1: dose reduction of antipsychotics at a rate not exceeding 50mg chlorpromazine equivalent/week
Interventions: intervention 1: reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT03025945
Conditions: Cystoid Macular Edema
Sponsor: Intuor Technologies, Inc.
Start date: 2013-10-01; Completion date: 2017-01-01
Enrollment: 662 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Prospective, randomized, double-masked, placebo-controlled clinical study to define the effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema.

Detailed description:

Arms: arm 1: nepafenac 0.3% ophthalmic solution dosed once daily arm 2: sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily
Interventions: intervention 1: Nepafenac 0.3% intervention 2: Saline Solution
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: