ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02055898
Conditions: Chronic Fatigue Syndrome
Keywords: Chronic fatigue syndrome
Sponsor: Imperial College London
Start date: 2014-04-01; Completion date: 2015-08-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators wish to investigate whether enhancement of SWS, which is seen after a drug called sodium oxybate, reduces the impact of sleep disruption in CFS on daytime function, specifically sleepiness and mental performance. This is a safe and well-tolerated drug that is licensed for excessive daytime sleepiness (EDS) and cataplexy associated with narcolepsy.

The investigators will study 12 patients diagnosed with CFS using international diagnostic guidelines. The investigators will record overnight sleep with EEG (brainwave) measurement on the 1st and 4th nights of a 4 night period during which sodium oxybate and placebo will be taken nightly, and the investigators will measure next-day sleepiness, mental performance and fatigue, and compare drug and placebo nights.

Detailed description:
Chronic fatigue syndrome (CFS), characterised by chronic disabling fatigue, sleep impairment and other symptoms, is associated with neither a currently identifiable disease process nor major psychiatric illness, and has an estimated prevalence in primary care of 1-2%. Sleep impairment is common in nearly everyone with CFS, with both daytime sleepiness and unrefreshing nighttime sleep reported, and consequent impact on daytime function. It may be that fundamental regulatory processes that control sleep are disturbed in CFS, leading to different effects on sleep and daytime symptoms depending on the subject's prior sleep, daytime routine, medication and other factors. The investigators contacts with patient groups have indicated that patients are generally confident that on days when their sleep is better they perform better in the day. There is growing evidence that deep, slow wave sleep (SWS) is altered in CFS, and this may suggest impairment of build up of sleep pressure during the day.

Arms: arm 1: Subjects received a single dose of placebo comparator (fresh potable water) at bedtime on 4 nights during an inpatient stay of 5 days in the research centre. This was followed by an interval of at least 2 weeks. They were then admitted again and received a single dose of sodium oxybate (3.0g as liquid) at bedtime for 4 nights arm 2: Subjects received a single dose of sodium oxybate (3.0g as liquid) at bedtime on 4 nights during an inpatient stay of 5 days in the research centre. This was followed by an interval of at least 2 weeks. They were then admitted again and received a single dose of placebo comparator (fresh potable water) at bedtime for 4 nights
Interventions: intervention 1: Sodium Oxybate intervention 2: placebo (fresh potable water)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02069119
Conditions: Atrial Fibrillation
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2014-02-01; Completion date: 2015-08-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the safety, pharmacokinetics, and efficacy following 30-minute continuous intravenous administration of OPC-108459 at 0.4, 0.8, 1.6, or 2.4 mg/kg or placebo to patients with paroxysmal or persistent atrial fibrillation

Detailed description:

Arms: arm 1: OPC-108459 solution will be intravenously administered by 30-minute infusion in the forearm. arm 2: placebo solution will be intravenously administered by 30-minute infusion in the forearm.
Interventions: intervention 1: OPC-108459 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02073747
Conditions: Asthma
Keywords: Albuterol Serum Lactate Lactic Acidosis Asthma
Sponsor: University Medical Center of Southern Nevada
Start date: 2015-04-01; Completion date: 2015-08-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Empirical data from physician observation indicates an increase in serum lactate in acute asthmatic patients being treated with inhaled albuterol therapy.

It is not clear if this increased serum lactate is in response to a physiological response to the asthmatic process or from the albuterol treatment.

This study is designed to determine if administration of inhaled albuterol increases serum lactate in healthy subjects.

Detailed description:
Approximately 30 healthy volunteers will be randomized to Albuterol or placebo. We powered our study to detect a difference of 0.5 mmol/L, but hypothesize that the difference will be greater than 1.0 mmol/L.

All volunteer subjects will sign a written consent, approved by the Institutional Review Board. The intended pool of volunteers will be from residents, attendings, and medical students in the hospital. The consent form will clearly specify that their participation in the study will not impact their academic status or employment.

The subjects randomized to the Albuterol arm will receive a one hour 10 mg continuous Albuterol nebulizer treatment. Those randomized to placebo will receive a one-hour saline nebulizer treatment. The chief pharmacist for the study will randomly assign a number between one and thirty to fifteen Albuterol treatments and fifteen placebo treatments.

Subjects will be monitored with cardiac monitor and serum lactate levels will be drawn every 15 minutes.

Arms: arm 1: Control group will be administered a one hour normal saline inhaled treatment. arm 2: Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol
Interventions: intervention 1: Normal Saline intervention 2: Albuterol
Intervention descriptions: intervention 1: One hour inhaled normal saline intervention 2: One hour inhaled ten milligrams of albuterol

Protocol documents:
Clinical trial NCT02084628
Conditions: Magnetic Resonance Imaging
Sponsor: Bayer
Start date: 2015-02-01; Completion date: 2015-08-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multi-center study involving babies 0-2 months of age who have liver problems (pathology) and need to have their liver and possibly, the bile ducts imaged using magnetic resonance imaging and injection of a contrast agent (dye). This agent is called Eovist. It has been marketed since 2004 and used in many countries all over the world.

The baby will have blood tests before and after the imaging is done to make sure that there are no unexpected findings before and after the imaging. Also 3 blood samples up to 8 hours after the injection will be obtained in order to measure how much of the dye is in the blood. The baby will have an intravenous line which can be used for the blood samples and will not need to be stick for the blood samples. Several radiologists will evaluate the images. The family doctor will be contacted to find out what was the diagnosis and treatment after the results of the MRI were known. Six months after the study, the parent(s)/legal guardian(s) will be contacted to make sure the that baby did not have any problems, especially with the skin, joints and eyes.

Detailed description:
In order to minimize bias in assessment of the images, blinded reading of the MR images will be performed by 2 blinded readers. The blinded readers will be independent board-certified pediatric radiologists who have no knowledge about the subjects and are not affiliated with any of the clinical sites.

Arms: arm 1: Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole \[mmol\]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent \[%\] solution) manually.
Interventions: intervention 1: Gadoxetate disodium (Eovist/Primovist, BAY86-4873)
Intervention descriptions: intervention 1: Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole \[mmol\]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent \[%\] solution) manually.

Protocol documents:
Clinical trial NCT02085460
Conditions: Head and Neck Cancer
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2014-03-01; Completion date: 2015-08-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer following administration of rebamipide and to determine the optimal dose of rebamipide.

Detailed description:

Arms: arm 1: 6 times daily arm 2: 6 times daily arm 3: 6 times daily
Interventions: intervention 1: Placebo intervention 2: 2% Rebamipide liquid intervention 3: 4% Rebamipide liquid
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02120300
Conditions: Chronic HCV Infection
Sponsor: Gilead Sciences
Start date: 2014-04-01; Completion date: 2015-08-01
Enrollment: 122 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) in participants with genotypes 2 and 3 HCV infection. Participants with an inherited bleeding disorder and chronic HCV infection (either monoinfected or HIV-1/HCV coinfected) will be enrolled.

Detailed description:

Arms: arm 1: Participants with chronic genotypes (GT) 1 or 4 HCV infection will receive LDV/SOF for 12 or 24 weeks. Treatment-experienced cirrhotic participants with genotype 1 HCV infection will receive LDV/SOF for 24 weeks. arm 2: Participants with chronic genotype 2 HCV infection will receive SOF+RBV for 12 weeks. arm 3: Participants with chronic genotype 3 HCV infection will receive SOF+RBV for 24 weeks.
Interventions: intervention 1: LDV/SOF intervention 2: SOF intervention 3: RBV
Intervention descriptions: intervention 1: 90/400 mg FDC tablet administered orally intervention 2: 400 mg tablet administered orally once daily intervention 3: Ribavirin (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:
Clinical trial NCT02130063
Conditions: Iron Deficiency Anaemia
Keywords: IDA Iron deficiency iron deficiency anaemia and who are intolerant or unresponsive to oral iron therapy
Sponsor: Pharmacosmos A/S
Start date: 2014-05-01; Completion date: 2015-08-01
Enrollment: 511 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.

Detailed description:
IDA is highly prevalent in subjects with gastrointestinal diseases and cancer, menstruating or pregnant women, and subjects who have undergone bariatric procedure. IDA can have a substantial medical and quality of life (QoL) burden on the subjects and the treatment of these subjects includes controlling the bleeding and replenishing lost iron. Oral iron administration is often used in the clinical practice at many clinics; however, oral iron may not be tolerated by all subjects. Hence, there is a need for an alternative iron treatment in subjects, who do not tolerate oral iron.

This study is planned to compare the efficacy and safety of iron isomaltoside 1000 with another parenteral iron preparation (iron sucrose) in subjects with IDA and who are intolerant or unresponsive to oral iron therapy or who need iron rapidly.

Arms: arm 1: iron isomaltoside 1000 (Monofer®) arm 2: iron sucrose (Venofer®)
Interventions: intervention 1: iron isomaltoside 1000 (Monofer®) intervention 2: iron sucrose (Venofer®)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02144285
Conditions: Kidney Failure, Chronic
Keywords: Renal dialysis
Sponsor: Eli Lilly and Company
Start date: 2014-06-01; Completion date: 2015-08-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to look at the tolerability and safety of LY3113593. Study doctors will see how safe it is and whether it produces side effects following a single injection into a vein or under the skin in healthy participants (Part A) and participants with chronic kidney disease treated with hemodialysis (Part B). The study will also measure how much of the study drug gets into the blood stream, how long it takes the body to get rid of the study drug and what effects the study drug has on the body.

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. For each participant, the study will last about 85 days, not including screening. Screening is required within 28 days prior to the start of the study.

Detailed description:

Arms: arm 1: Single dose of LY3113593 administered intravenous (IV) at a minimum of six dose levels arm 2: Single dose of placebo matching LY3113593 administered IV arm 3: Single dose of LY3113593 administered subcutaneous (SC) arm 4: Single dose of placebo matching LY3113593 administered SC arm 5: Single dose of LY3113593 administered IV arm 6: Single dose of placebo matching LY3113593 administered IV
Interventions: intervention 1: LY3113593 intervention 2: LY3113593 intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered SC intervention 3: Administered IV intervention 4: Administered SC

Protocol documents:
Clinical trial NCT02156466
Conditions: Psoriasis
Keywords: Psoriasis MSB0010841 Anti-IL17A/F Nanobody M1095
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2014-08-01; Completion date: 2015-08-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, Phase 1, randomized, double-blind, placebo-controlled trial in subjects with moderate to severe psoriasis to assess the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of multiple subcutaneous ascending doses of MSB0010841 (Anti-interleukin-17A/F \[Anti-IL-17A/F\] Nanobody).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: MSB0010841 intervention 2: MSB0010841 intervention 3: MSB0010841 intervention 4: MSB0010841 intervention 5: Placebo
Intervention descriptions: intervention 1: MSB0010841(Anti- IL-17A/F Nanobody) will be administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks. intervention 2: MSB0010841 will be administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks. intervention 3: MSB0010841 will be administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks. intervention 4: MSB0010841 will be administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks. intervention 5: Placebo matched to MSB0010841 will be administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.

Protocol documents:
Clinical trial NCT02171130
Conditions: Hypoglycemia Diabetes Mellitus Drug-Specific Antibodies
Keywords: Diabetes Mellitus Hypoglycemia Glucagon Anti-glucagon Antibody Immunogenicity
Sponsor: Eli Lilly and Company
Start date: 2014-05-01; Completion date: 2015-08-01
Enrollment: 129 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Up to two hundred (200) adult participants with type 1 diabetes (T1D) aged 18 to 75 years will be selected for inclusion in the study. The target is to obtain treatment response and user-experience data following use of nasal glucagon (AMG504-1) in treating episodes of hypoglycemia. The population will be enriched to include participants who suffer from impaired hypoglycemia awareness.

Detailed description:
This study is designed to evaluate the effectiveness of nasal glucagon (NG) administered under clinical use conditions in treating episodes of hypoglycemia in persons with T1D.

This study also aims to assess the ease with which caregivers can administer the experimental medication in treatment of hypoglycemic events.

The study will also generate data on the participants' assessment of local tolerability and provide information on immunogenicity of nasal glucagon with regards to the potential development of anti-glucagon antibodies.

Arms: arm 1: 3 mg nasal glucagon powder delivered using a nasal powder dosing device.
Interventions: intervention 1: Nasal Glucagon
Intervention descriptions: intervention 1: 3 mg nasal glucagon powder

Protocol documents:
Clinical trial NCT02173301
Conditions: Psoriasis
Sponsor: Dr. Reddy's Laboratories Limited
Start date: 2014-06-01; Completion date: 2015-08-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study objectives are the following:

1. To evaluate the efficacy of 3 doses of XP23829 compared to placebo for the treatment of moderate-to-severe chronic plaque-type psoriasis.
2. To evaluate the safety and tolerability of XP23829 in subjects with psoriasis.
3. To evaluate the pharmacodynamics (PD) of XP23829 through immunological analysis of peripheral blood samples.

Detailed description:
Study Design : This is a , multi-center, double blind, placebo-controlled, phase 2 (dose-finding) efficacy and safety study in which subjects with moderate-to- severe chronic plaque-type psoriasis will be randomized in a 1:1:1:1 allocation ratio to 1 of 3 active doses of XP23829 or placebo. Approximately 50 subjects will be enrolled into each treatment group.

Study Periods: The study includes a 4-week screening phase, a 12-week treatment phase (with 9 weeks of XP23829 or placebo at the maintenance dose), and a 4-week observational post-treatment follow-up phase. A treatment-free follow-up period is designed to evaluate safety and disease relapse and rebound.

Specifically, the study periods are as follows:

1. Screening Phase: Weeks -4 through 0
2. Treatment phase included:

   1. Titration Phase: Weeks 1 through 3
   2. Double-Blind Maintenance Phase: Weeks 4 through 12
3. Post-treatment follow-up: Weeks 13 through 16

Efficacy assessments will be performed in the clinic at Baseline (Visit 2) and at the end of Weeks 2, 4, 8, 12, 14, and 16.

Patient-reported outcome measures will be assessed in the clinic at Baseline and at Week 12.

Blood samples for pharmacodynamic (PD) assessments will be collected at Baseline and at Weeks 4, 8, 12 and 16. PD assessments will be conducted in all subjects, with the intent of evaluating psoriasis-associated inflammatory markers.

Arms: arm 1: After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period arm 2: After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period arm 3: After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period arm 4: After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks
Interventions: intervention 1: XP23829 400 mg QD intervention 2: XP 23829 800 mg QD intervention 3: XP23829 400 mg BID intervention 4: Placebo
Intervention descriptions: intervention 1: active dose 1 intervention 2: active dose 2 intervention 3: active dose 3 intervention 4: control

Protocol documents:
Clinical trial NCT02249065
Conditions: Rosacea
Sponsor: Galderma R&D
Start date: 2014-09-01; Completion date: 2015-08-01
Enrollment: 205 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to:

1. assess the signs and symptoms of rosacea, including erythema, without treatment and during treatment with Mirvaso® gel
2. further characterize lifestyle impact and patient satisfaction with Mirvaso® treatment
3. gain a better understanding of the real-world use of Mirvaso® on the pattern and management of facial erythema of rosacea.

Detailed description:

Arms: arm 1: Brimonidine topical gel, 0.33%
Interventions: intervention 1: Brimonidine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02251652
Conditions: Actinic Keratoses
Keywords: Actinic
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2013-04-01; Completion date: 2015-08-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Sequential therapy with cryosurgery and ingenol mebutate may optimize the treatment of hypertrophic AKs and also treat non-hypertrophic AKs in this anatomic location. Furthermore, use of ingenol mebutate will also be evaluated for potential treatment of subclinical lesions.

Detailed description:
The investigators plan to treat 30 subjects. Each qualifying subject will have at least 3 hypertrophic AKs, defined as more than 3mm in thickness, on each dorsal hand. Cryotherapy will be standardized in all patients and for all treated lesions: 1-2 sprays, 5 seconds each, with a 5 second interval. All subjects will be treated with the same cryo-spray. Following cryotherapy, subjects will be randomized to treat either their right or left dorsal hand with ingenol mebutate gel. The decision to treat the right vs. the left hand will be chosen by chance, like flipping a coin. Neither the subject nor the study doctor will choose what arm receives the ingenol mebutate gel. The study doctor will not know which arm is treated with ingenol mebutate, so the subject should not reveal that information to him or her at any time during the study. Subjects will treat the randomized dorsal hand with ingenol mebutate 0.05% gel starting on the same day as the cryotherapy (Day 0). Subjects will utilize the once daily for two days regimen. Subjects will be followed on day 4 after their initial visit, day 8, day 15, day 29, and day 57, with a two day window period.

Arms: arm 1: Cryotherapy followed by Ingenol Mebutate Gel arm 2: Cryotherapy only
Interventions: intervention 1: Ingenol Mebutate intervention 2: Cryotherapy
Intervention descriptions: intervention 1: Ingenol mebutate 0.05% gel intervention 2: 1-2 sprays, 5 seconds each, with a 5 second interval

Protocol documents:
Clinical trial NCT02262754
Conditions: Chronic Low Back Pain
Sponsor: Pfizer
Start date: 2014-10-01; Completion date: 2015-08-01
Enrollment: 302 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
PF-06372865 In Subjects With Chronic Low Back Pain

Detailed description:

Arms: arm 1: Daily BID dosing for 4 weeks arm 2: Daily BID dosing for 4 weeks arm 3: Daily BID dosing for 4 weeks
Interventions: intervention 1: PF-06372865 intervention 2: Placebo intervention 3: Naproxen
Intervention descriptions: intervention 1: Dose level 1 daily dosing BID for 1 week followed by dose level 2 daily BID for 3 weeks intervention 2: Placebo for PF-06372865 and placebo for naproxen daily intervention 3: 500 mg BID for 4 weeks

Protocol documents: