ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02481219
Conditions: Colorectal Cancer Screening
Keywords: Polyps Capsule endoscopy Bowel preparation regimen Average risk patients for colorectal cancer screening
Sponsor: Medtronic - MITG
Start date: 2015-05-01; Completion date: 2016-02-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to determine the optimal bowel preparation regimen for PillCam® COLON 2 Capsule Endoscopy System (CCE) procedures in average risk patients.

Patients will be randomized to receive one of two bowel preparation regimens prior to PillCam CCE.

Detailed description:
This is a multicenter, prospective, consecutive, randomized study. Average-risk subjects undergoing CCE without optical colonoscopy will be consecutively enrolled and randomized 1:1 to receive one of two bowel preparation regimens prior to PillCam CCE.

Subjects will be enrolled at 5-10 clinical sites in the United States. Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit and will be evaluated on the procedure day or until capsule excretion. A telephone follow-up will be conducted 5 to 9 days post-capsule ingestion to verify capsule excretion, assess patient well-being, and capture any adverse events.

Arms: arm 1: Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository. arm 2: Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
Interventions: intervention 1: PillCam® COLON 2 procedure-CONTROL intervention 2: Senna tablets intervention 3: PEG intervention 4: Metoclopramide intervention 5: Erythromycin intervention 6: SUPREP oral sulfate solution intervention 7: Bisacodyl intervention 8: SUPREP oral sulfate solution with Gastrografin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None

Protocol documents:
Clinical trial NCT02500628
Conditions: Fibromyalgia Mitochondrial Diseases Movement Disorders Diabetes Mellitus, Type 2
Keywords: metformin mitochondria complex 1 fibromyalgia neurogenic pain diabetes tardive dyskinesia heart rate variability
Sponsor: Woodinville Psychiatric Associates
Start date: 2015-07-01; Completion date: 2016-02-01
Enrollment: 61 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Diseases caused by brain energy supply defects can be innate (fibromyalgia secondary to familial mitochondrial disorders) or acquired (tardive dyskinesia or weight gain associated with prolonged antipsychotic use). Patients with these possible mitochondrial disorders will provide a baseline resting heart rate sample, ingest low-dose metformin (500 mg), and then provide an additional sample 2 hours later.

Detailed description:
Doctors need to develop tests which inexpensively and reliably evaluates brain metabolism. Current diagnostic tests sample other tissues which often run on different fuels (fats), utilize unproven and often insensitive brain imaging scanners, or sequence thousands to millions of base-pairs of DNA. All of these tests are expensive. None of these tests accurately or completely capture the interactions between the 1000s of proteins involved in brain metabolism.

The investigators suspect that mathematical analysis of the resting heart rate may provide some insight into brain metabolism. The brain controls heart rate in response to changes in blood pressure and blood gases like carbon dioxide and oxygen. Tight control of heart rate is necessary to make sure that the brain has the right mix of fuel and air. Because the brain can't respond instantly to changes in its fuel supply, this system acting as a biological carburetor has a natural oscillatory rhythm that can be monitored just like frequencies on the radio.

The investigators propose to amplify these rhythms by modestly metabolically stressing the brain with metformin, a inhibitor of complex 1 in the mitochondria.

Arms: arm 1: Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg orally in the morning arm 2: Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg orally in the morning
Interventions: intervention 1: Metformin
Intervention descriptions: intervention 1: 500 mg orally after baseline testing of heart rate

Protocol documents:
Clinical trial NCT02621060
Conditions: Impaired Glucose Tolerance
Keywords: Chlorogenic acid Control glucose Insulin Secretion Insulin Sensitivity
Sponsor: University of Guadalajara
Start date: 2015-09-01; Completion date: 2016-02-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Chlorogenic acid has demonstrated promising effects in the treatment of glycemic control, obesity, dyslipidemia, insulin secretion, among others. The above mentioned findings show that Chlorogenic acid has an excellent potential for the control of glucose as well as insulin secretion and insulin sensitivity.

Detailed description:
A randomized, double-blind, placebo-controlled clinical trial was carried out in 30 patients with a diagnosis of impaired glucose tolerance in accordance with the American Diabetes Association criteria. The patients received 400 mg capsules of Chlorogenic acid or placebo, three times daily 1/ 2 hour before meals for 90 days. Before and after intervention the investigators evaluated: 2 hours plasma glucose, glycated hemoglobin (A1C), triglycerides, high-density lipoprotein, fasting glucose and blood pressure body weight, body mass index, waist circumference, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase.

Were calculated: Areas under the curve of glucose and insulin were calculated with de Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and the insulin sensitivity was estimated using the Matsuda index.

Arms: arm 1: 1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days. arm 2: 1200 mg dose per day, three capsules of 400 mg, times daily 1/ 2 hour before meals during 90 days.
Interventions: intervention 1: Placebo intervention 2: Chlorogenic acid
Intervention descriptions: intervention 1: Placebo: 1200 mg per day for three months intervention 2: Chologenic acid: 1200 mg per day for three months

Protocol documents:
Clinical trial NCT02628106
Conditions: Diabetic Nephropathy
Sponsor: West China Hospital
Start date: 2015-12-01; Completion date: 2016-02-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effect of lipo-prostaglandin E1 （lipo-PGE1) on renal oxygenation in patients with diabetic nephropathy by blood oxygenation level dependent magnetic resonance imaging (BOLD-MRI).patients with stable chronic kidney disease (CKD) were included. All patients were divided into two groups: diabetic nephropathy（DN) and CKD without diabetes. In addition to the conventional treatments, all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days. Kidney BOLD-MRI were performed before and after lipo-PGE1 administration to acquire bilateral renal cortical R2\*(CR2\*) and medullary R2\* (MR2\*) values. Meanwhile, the clinical indexes at baseline and under lipo-PGE1 including 24 hours urinary protein and serum creatinine were collected. the investigators want to prove Lipo-PGE1 can improve kidney medullary oxygenation in patients with DN.

Detailed description:
R2\* maps were calculated using the in-house software in Matlab (version 7.0, The MathWorks, Inc., Cambridge, MA, USA) on a pixel-by-pixel basis by fitting㏑(signal intensity) versus echo time. The R2\* map was windowed from 0 to 60 s-1.

Regions of interest (ROIs) with unfixed size (7 to 53 pixels) were defined at the upper, middle and lower poles of both kidneys in the medulla and cortex in the renal hilum plane based on the anatomical images. Three ROIs were placed in the medulla and cortex, respectively, carefully avoiding vessels, renal sinus and susceptibility artifacts, yielding a total of 6 ROIs in both kidneys. The values in each ROI were averaged for the bilateral cortex and medulla. To prevent significant bias from measurement variability, each sample was measured independently by three professional radiologists with more than 5 years of experience who were blinded to the clinical results. Thereafter, assuming the tests were coincident, the results were the averaged.

Arms: arm 1: all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days.
Interventions: intervention 1: Lipo-PGE1
Intervention descriptions: intervention 1: all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days

Protocol documents:
Clinical trial NCT02636361
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2015-12-01; Completion date: 2016-02-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the different formulations of LY900014. This study will determine how the different formulations, when injected under the skin, will affect the blood sugar levels in the body, and how safe it is.

Detailed description:

Arms: arm 1: Test formulation B: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods arm 2: Test formulation B: Single dose of LY900014 formulation administered SC in one of five periods arm 3: Test formulation C: Single dose of LY900014 formulation administered SC in one of five periods arm 4: Formulation D: Single dose of LY900014 formulation administered SC in one of five periods arm 5: Reference formulation: Single dose of lispro administered SC in one of five periods
Interventions: intervention 1: LY900014 intervention 2: Insulin lispro (Humalog)
Intervention descriptions: intervention 1: Administered subcutaneously (SC) intervention 2: Administered SC

Protocol documents:
Clinical trial NCT02734355
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation catheter ablation left atrium mechanical function contractility
Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Start date: 2015-11-01; Completion date: 2016-02-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study was to estimate the efficacy of telmisartan and amlodipine combination on the restoration of left atrial mechanical function after atrial fibrillation catheter ablation.

Detailed description:
64 candidates to atrial fibrillation ablation were included in the study. Patients were randomly assigned to telmisartan/amlodipine combination in dose 80/5 mg (group I, n=34) or placebo (group II, n=30) taking daily for up to one week. Echocardiography was performed before the procedure, immediately after it, and after a week of therapy. The six-minute walk test and SF-36 questionnaire results were evaluated a day before the procedure and after a week of the therapy. The left ventricular end-diastolic pressure was invasively measured after transseptal puncture and before left atrial sheath removal.

Arms: arm 1: Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days arm 2: Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
Interventions: intervention 1: Telmisartan 80 mg and amlodipine 5 mg intervention 2: Placebo (for telmisartan and amlodipine)
Intervention descriptions: intervention 1: None intervention 2: Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet

Protocol documents:
Clinical trial NCT02865018
Conditions: Neuromyelitis Optica
Keywords: Neuromyelitis Optica Cetirizine
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2014-04-01; Completion date: 2016-02-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Neuromyelitis optica (NMO) is an autoimmune disease that affects the central nervous system. Patients have relapses (also known as attacks) which are often quite severe and leave them with significant disability. Without treatment, within 5 years 50% of NMO patients are blind in one or both eyes or require walking assistance (cane, walker or wheelchair).

NMO has only been relatively recently described and is fairly rare. Most NMO patients' immune systems produce abnormal antibodies against aquaporin-4 (AQP4), which is found in certain cells in the central nervous system. When these AQP4 antibodies bind to AQP4, they trigger a cascade of events involving the immune system which eventually leads to damage to the nervous system. This ultimately leads to disability, some of which is permanent.

Until now, treatments for NMO have been mostly focused on decreasing production of this AQP4 antibody. However, recent experiments in animal models of NMO have shown the importance of what happens inside the central nervous system after the antibody binds to the nervous system cell. Specifically, researchers have noted the importance of a specific cell type, eosinophils, in causing damage in NMO lesions. In a recent study, researchers showed they could prevent damage from NMO by blocking eosinophils using cetirizine, which is a popular over-the-counter allergy medicine.

Cetirizine is already known to be safe and well-tolerated in the general population. In this study, the researchers plan to add cetirizine on to patients' current NMO treatment. The researchers aim to show that it is safe, well-tolerated, and that with cetirizine, NMO patients have less relapses and therefore less disability over the course of the year following initiation of treatment. The researchers also plan to study how cetirizine changes the immunological profile in NMO patients by examining blood and cerebrospinal fluid.

Detailed description:
The researchers hypothesize that cetirizine, an allergy medication that acts as an eosinophil-stabilizer, will decrease the relapse rate when added to current standard therapy in patients with neuromyelitis optica.

Medication compliance will be assessed by the research coordinator at each visit through discussion with the patient and pill counting.

Arms: arm 1: 10mg oral each day
Interventions: intervention 1: cetirizine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT03220048
Conditions: Influenza A H3N2
Sponsor: Hvivo
Start date: 2015-09-16; Completion date: 2016-02-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 2 study, looking at the prophylactic efficacy, safety and tolerability to a repeated nasal dose of study drug after being infected with Influenza A/Perth/16/2009 (H3N2) virus.

Detailed description:
Screening took place up to 90 days before quarantine. Volunteers completed an informed consent and underwent screening assessments to determine their eligibility.

There were 2 study groups:

Cohort A: (Sentinel): determined the Challenge Virus infection rate after inoculation with Influenza Virus on Day 0. There was 12 subjects (open label, no randomisation) invited to attend Quarantine on Day -2 or -1.

Cohort B: Examined the prophylactic efficacy, safety and tolerability of PrEP-001 compared to placebo (randomised 1:1). Subjects attended on Day -4/-3, dosed with PrEP-001 or Placebo on Day -2 AND Day-1 and then challenged with virus (volume confirmed from Cohort A) on Day 0.

Volunteers remained in quarantine unit for 8 days after inoculation.

At day 28, end of study visit, volunteers seen and assessed by a study physician for well-being, on-going symptoms and adverse events.

Arms: arm 1: Sentinel group in which subjects received a challenge virus inoculum volume of 100uL on Day 0. arm 2: PrEP-001 6400μg dose administered equally over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule. arm 3: Nasal dose of placebo Comparator equally divided over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.
Interventions: intervention 1: PrEP-001 intervention 2: Placebo Comparator
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02072434
Conditions: Atrial Fibrillation
Keywords: Nonvalvular atrial fibrillation (NVAF) anti-coagulant warfarin edoxaban electrical cardioversion
Sponsor: Daiichi Sankyo
Start date: 2014-03-25; Completion date: 2016-02-03
Enrollment: 2199 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It will see if edoxaban prevents stroke and other blood clotting problems as well and as safely as warfarin. People with atrial fibrillation (irregular heartbeat) might be able to join. Their doctors must plan to use shock to make their hearts beat normally. About 2200 people from different countries will join. They will have an equal chance of receiving either treatment. They are anticipated to be in the study for around 82 days. Tests will include physicals and finger-pricks. Participants will provide blood and urine samples.

Detailed description:
The purpose of this study is to compare edoxaban (investigational drug) with warfarin and enoxaparin, to see if it is safe and effective in preventing stroke and other blood clot complications in subjects with atrial fibrillation whose doctors plan to treat them with an electrical cardioversion. It is expected that 284 sites will recruit 2200 subjects from North America, EU, Russia, Ukraine and Israel. Participants will be randomly allocated to receive either treatment with edoxaban, or treatment with warfarin, plus enoxaparin if required. Participants will have an equal chance of receiving either treatment. Participants will be in the study for a maximum of 82 days. Study procedures will include physical examinations, vital signs (pulse and sitting blood pressure), ECG (electrocardiogram), finger prick blood clotting tests, blood samples and urine samples.

The study is expected to show that edoxaban will provide comparable incidence rates to warfarin plus enoxaparin, the current standard treatment for both efficacy and bleeding.

Arms: arm 1: Edoxaban oral tablet, 60 mg-once daily (QD), reduced to 30 mg based on protocol-defined parameters, for up to 49 days arm 2: Participants naïve to anticoagulation, taking anticoagulants other than a Vitamin K antagonist (VKA) or taking a VKA but with a prothrombin time (PT) international normalized ratio (INR) of less than 2.0 receive enoxaparin until they reach a PT INR of at least 2.0, before taking warfarin.

All participants in this arm receive warfarin oral tablet QD at their doctor's prescribed dose, for up to 49 days.
Interventions: intervention 1: Edoxaban intervention 2: Warfarin intervention 3: Enoxaparin
Intervention descriptions: intervention 1: Edoxaban 30 mg tablets for oral administration intervention 2: Warfarin tablet, 1.0 or 2.5 mg, for oral administration intervention 3: Enoxaparin per label, at prescribed dose until PT INR at least 2.0

Protocol documents:
Clinical trial NCT02424253
Conditions: Atopic Dermatitis
Sponsor: Ziarco Pharma Ltd
Start date: 2015-05-18; Completion date: 2016-02-03
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a randomized, double blind, placebo controlled, parallel group study in approximately 90 subjects with moderate-severe AD Eczema Area and Severity Index (EASI) ≥12 and ≤ 48 (0-72 scale). Following a run-in subjects were randomized to receive either oral 30 mg ZPL-3893787 once daily (od) or placebo od for 8 weeks (56 days).

Detailed description:

Arms: arm 1: 30 mg ZPL-3893787 orally once daily for 8 weeks. arm 2: 1 capsule orally once daily for 8 weeks.
Interventions: intervention 1: ZPL-3893787 intervention 2: Placebo
Intervention descriptions: intervention 1: ZPL-3893787 intervention 2: Matched Placebo

Protocol documents:
Clinical trial NCT01620255
Conditions: Ulcerative Colitis
Sponsor: Shire
Start date: 2012-11-02; Completion date: 2016-02-04
Enrollment: 357 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Placebo intervention 2: PF-00547659 SC Injection intervention 3: PF-00547659 SC Injection intervention 4: PF-00547659 SC Injection intervention 5: PF-00547659 SC Injection
Intervention descriptions: intervention 1: Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks intervention 2: Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks intervention 3: Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks intervention 4: Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks intervention 5: Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks

Protocol documents: