ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01955707
Conditions: Acute Ischemic Stroke
Sponsor: Biogen
Start date: 2014-01-01; Completion date: 2015-04-01
Enrollment: 161 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine whether one 300 mg dose of intravenous (IV) natalizumab reduces change in infarct volume from Baseline to Day 5 on magnetic resonance imaging (MRI) in participants with acute ischemic stroke when given at ≤6 hours or at \>6 to ≤9 hours from when they were last known normal (LKN).

The secondary objectives of this study in this study population are as follows: to assess the efficacy of natalizumab on change in infarct volume from Baseline to Day 30; to assess efficacy of natalizumab on change in infarct volume from 24 hours to Day 5 and Day 30; to assess the efficacy of natalizumab on clinical measures of stroke outcome; to assess the safety of natalizumab in participants with acute ischemic stroke.

Detailed description:

Arms: arm 1: 300 mg single intravenous (IV) injection arm 2: A single IV dose of placebo
Interventions: intervention 1: natalizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered as described in the treatment arm intervention 2: Matched placebo

Protocol documents:
Clinical trial NCT01966120
Conditions: Actinic Keratosis
Keywords: Photodynamic Therapy Field-directed Treatment
Sponsor: Biofrontera Bioscience GmbH
Start date: 2013-10-01; Completion date: 2015-04-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of BF-200 ALA (Ameluz) versus placebo in the field-directed treatment of mild to moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED lamp.

Detailed description:
The study was performed as a randomized, multicentre, double-blind, placebo- controlled, parallel-group, phase III trial with BF-200 ALA and placebo in seven centres in Germany. A total of 94 patients were screened in this study; 87 were randomized (55 patients received BF-200 ALA, 32 received placebo). Patients received one PDT. If residual lesions remained at 3 months after treatment, PDT was repeated. Illumination was performed with the PDT lamp BF-RhodoLED.

Arms: arm 1: Photodynamic therapy with BF-RhodoLED in combination with BF-200 ALA. arm 2: Photodynamic therapy with BF-RhodoLED in combination with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.
Interventions: intervention 1: BF-200 ALA gel intervention 2: Placebo to BF-200 ALA gel intervention 3: Photodynamic therapy with BF-RhodoLED
Intervention descriptions: intervention 1: BF-200 ALA was applied over 1-2 fields of approximately 20 cm² in total, allowed to dry for approximately 10 minutes, and covered with occlusive tape material for 3 h. intervention 2: The reference product was a placebo (a nanoemulsion gel formulation similar to the Investigational Medicinal Product (IMP), but without the active ingredient). The placebo was packaged, assigned to each patient, and administered in the same way as the IMP. intervention 3: After cleaning the lesions, the entire treatment field(s) were illuminated using the novel narrow spectrum BF-RhodoLED lamp, a red light illumination source (approximately 635 nm) developed by Biofrontera, until a total light dose of 37 J/cm² (per treated field) was achieved.

Protocol documents:
Clinical trial NCT01977456
Conditions: Stroke Brain Infarction
Keywords: acute ischemic stroke stroke rt-PA, thrombolytic t-PA recombinant tissue plasminogen activator Activase eptifibatide Integrilin fibrinolytic agents clot dissolving blood clot
Sponsor: Arthur Pancioli
Start date: 2013-09-01; Completion date: 2015-04-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary goal of this trial is to determine if individuals with acute ischemic stroke treated with a full dose of IV recombinant tissue plasminogen activator (rt-PA) plus IV eptifibatide started within 3 hours of symptom onset are more likely to have a better outcome than individuals treated with standard IV rt-PA alone.

Detailed description:
The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke-Full Dose Regimen (CLEAR-FDR Stroke Trial) is a Phase II trial and part of the Specialized Program on Translational Research in Acute Stroke (SPOTRIAS). The overall goals of SPOTRIAS are to enhance delivery of acute stroke patient care and train acute stroke translational researchers.

Stroke most often occurs when blood flow to the brain stops because it is blocked by a blood clot. When a blood clot blocks the blood supply to the brain, parts of the brain may not get enough blood and oxygen to survive. As a result, permanent brain damage can occur, which can affect a person's ability to walk, talk, and function independently. In order to reduce the risk of permanent damage, it is important to restore blood flow to the brain as quickly as possible.

rt-PA, used alone, is already approved by the Food and Drug Administration (FDA) as treatment for patients with a stroke caused by blockage of an artery in the brain and when given within 3 hours of the onset of stroke symptoms. Eptifibatide is also already FDA-approved as a treatment for blood clots causing heart attack. The investigational aspect of this study is the use of eptifibatide for a stroke victim in combination with rt-PA.

The CLEAR Stroke Trial demonstrated that the combination of low dose rt-PA plus eptifibatide can be safely given to acute ischemic stroke patients within 3 hours of symptom onset.

The CLEAR-ER Stroke Trial demonstrated that the combination of medium dose rt-PA plus eptifibatide can be safely given to acute ischemic stroke patients within 3 hours of symptom onset.

The CLEAR-FDR Stroke Trial is designed to provide data concerning the risks when combining eptifibatide with full dose intravenous rt-PA in 30 acute ischemic stroke patients within 3 hours of symptom onset.

Arms: arm 1: All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.
Interventions: intervention 1: Eptifibatide
Intervention descriptions: intervention 1: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.

Protocol documents:
Clinical trial NCT02010593
Conditions: Human Immunodeficiency Virus
Sponsor: International Partnership for Microbicides, Inc.
Start date: 2013-12-01; Completion date: 2015-04-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety of the dapivirine vaginal ring when inserts once every 4 weeks in postmenopausal women over 12 weeks of product use.

Detailed description:
Dapivirine, a non-nucleoside reverse-transcriptase inhibitor (NNRTI), is a substituted diamino- pyrimidine (DAPY) derivative with potent antiviral activity against HIV-1. Dapivirine is chemically described as 4-\[\[4-\[(2,4,6-trimethylphenyl)amino\]-2- pyrimidinyl\]amino\]benzonitrile.6 The dapivirine matrix VR is a flexible ring containing 25 mg of drug substance dispersed in a platinum-catalyzed-cured silicone matrix. Dapivirine is known to be well-suited for delivery via VR, as evidenced by favorable safety and pharmacokinetic data to date described below.

Arms: arm 1: Safety study of a vaginal ring containing Dapivirine in a postmenopausal female population arm 2: The placebo VR is a flexible, platinum-catalyzed-cured matrix ring, identical to Dapivirine Ring-004, containing no active-drug
Interventions: intervention 1: Dapivirine Vaginal Ring intervention 2: Placebo Vaginal Ring
Intervention descriptions: intervention 1: Dapivirine, a non-nucleoside reverse-transcriptase inhibitor (NNRTI), is a substituted amino- pyrimidine (DAPY) derivative with potent antiviral activity against HIV-1. Dapivirine is chemically described as 4-\[\[4-\[(2,4,6-trimethylphenyl)amino\]-2- pyrimidinyl\]amino\]benzonitrile.6 The dapivirine matrix VR is a flexible ring containing 25 mg of drug substance dispersed in a platinum-catalyzed-cured silicone matrix. Dapivirine is known to be well-suited for delivery via VR intervention 2: The placebo VR is a flexible, platinum-catalyzed-cured silicone matrix ring, identical to dapivirine Ring-004, containing no active drug.

Protocol documents:
Clinical trial NCT02048891
Conditions: Infertility
Sponsor: Rambam Health Care Campus
Start date: 2014-10-01; Completion date: 2015-04-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely, human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a natural cycle another hormone takes part in the process (follicle stimulating hormone, FSH). To induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing hormone (GnRH) agonist can be given.

The purpose of this study is to find out which approach may work better in IVF patients who experienced 4 IVF failures.

Detailed description:

Arms: arm 1: Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily. arm 2: ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
Interventions: intervention 1: GnRH agonist trigger intervention 2: hCG trigger
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02052635
Conditions: Non-ST Elevation Acute Coronary Syndrome
Keywords: Percutaneous Coronary Intervention
Sponsor: AstraZeneca
Start date: 2014-09-01; Completion date: 2015-04-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if ticagrelor is as effective as clopidogrel in rate of onset and degree of platelet inhibition for patients with non-ST elevation of acute coronary syndrome (NSTE-ACS) undergoing ad hoc percutaneous coronary intervention (PCI) with bivalirudin.

Detailed description:
Multi-center, open-label study that will compare the onset of the platelet inhibition with ticagrelor versus clopidogrel when administered with bivalirudin during PCI on a background therapy of aspirin in patients with NSTE-ACS.

Arms: arm 1: 90 mg oral tablet arm 2: 300 mg oral tablet
Interventions: intervention 1: ticagrelor intervention 2: clopidogrel
Intervention descriptions: intervention 1: Single loading dose of 180mg of ticagrelor at time of bivalirudin administration. Beginning 12 hrs following study drug administration, all pts in the ticagrelor arm will receive ticagrelor 90 mg (maintenance dose) approximately every 12 hrs until Follow-up telephone contact. intervention 2: Single loading oral dose of 600 mg of clopidogrel will be given at time of bivalirudin administration. Beginning 4 hrs following study drug administration, all pts in the clopidorgrel arm will receive ticagrelor 180 mg for the loading dose, followed by 90 mg maintenance dose approximately every 12 hours until the Follow-up telephone contact.

Protocol documents:
Clinical trial NCT02072200
Conditions: Rheumatoid Arthritis
Keywords: RA, MS, Safety, Efficacy, MR prednisone
Sponsor: Mundipharma Korea Ltd
Start date: 2013-09-01; Completion date: 2015-04-01
Enrollment: 147 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is multicenter, Ph IV, single arm, interventional study to assess relative reduction of morning stiffness of Lodotra® in Rheumatoid Arthritis patients.Study medication will start after study visit at baseline (week 0, visit 1) and follow-up visit will be after 2, 6 and 12 weeks after treatment (visit 2,3,4).

Detailed description:
Test Treatment, Dose, and Mode of Administration:

Starting dose is 10mg, and depending on the clinical symptoms and the patient's response, the initial dose can quickly be reduced to a lower maintenance dose. When changing over from the standard regimen (glucocorticoid administration in the morning) to Lodotra® administered at bedtime (at about 10 pm), the same dose (in mg prednisone equivalent) should be maintained, if the subject has taken stable dose within 30 days. Lodotra® dose cannot exceed more than 10mg.

Lodotra® should be taken at bedtime (at about 10 pm), with or after the evening meal and be swallowed whole with sufficient liquid. If more than 2 - 3 hours have passed since the evening meal, it is recommended to take Lodotra® with a light meal or snack.

Modified-release tablets are not to be broken, divided or chewed.

Treatment procedure:At Visit 1(week 0), subjects who qualify for entry into the study will medicated to Lodotra® starting dose of 10 mg daily. (Written informed consent has to be obtained, and subjects will undergo complete evaluation for study eligibility) No dose increase will be allowed for more than 10mg

Arms: arm 1: Single arm / Lodotra
Interventions: intervention 1: Lodotra®
Intervention descriptions: intervention 1: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response

Protocol documents:
Clinical trial NCT02075125
Conditions: ST-Segment Elevation Myocardial Infarction
Keywords: Korea Platelet inhibition Prasugrel Ticagrelor ST-segment elevation myocardial infarction
Sponsor: Dong-A University
Start date: 2014-01-01; Completion date: 2015-04-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare efficacy and safety of prasugrel and ticagrelor in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Detailed description:
Prasugrel and ticagrelor are recommended in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Both prasugrel and ticagrelor show more rapid and potent antiplatelet effect compared with clopidogrel. However, previous report comparing the efficacy and safety of prasugrel and ticagrelor in patients with STEMI of East Asian ethnicity is lacking. Therefore, the aim of this study is to compare the antiplatelet efficacy and safety using laboratory platelet function tests and clinical outcomes in patients with STEMI treated with either prasugrel or ticagrelor.

Arms: arm 1: Prasugrel 60 mg as loading dose and followed by 10 mg/day as maintenance dose arm 2: Ticagrelor 180 mg as loading dose and followed by 90 mg twice a day as maintenance dose
Interventions: intervention 1: Prasugrel 60 mg intervention 2: Ticagrelor 180 mg
Intervention descriptions: intervention 1: Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose. intervention 2: Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.

Protocol documents:
Clinical trial NCT02087059
Conditions: Primary Myelofibrosis (MF)
Keywords: Post-Polycythemia Vera (PV) MF Post-Essential Thrombocythemia (ET) MF
Sponsor: Novartis Pharmaceuticals
Start date: 2014-04-01; Completion date: 2015-04-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multicenter clinical study in order to collect and examine data concerning the safety and efficacy of ruxolitinib in patients with Primary Myelofibrosis (MF), Post-Polycythemia Vera (PV) MF, Post-Essential Thrombocythemia (ET) MF.

Detailed description:

Arms: arm 1: Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
Interventions: intervention 1: Ruxolitinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02094443
Conditions: Hepatitis C Liver Disease
Keywords: Chronic hepatitis C genotype 2 Chronic hepatitis C genotype 3 Cyclophilin inhibitor Interferon intolerant
Sponsor: Debiopharm International SA
Start date: 2014-03-01; Completion date: 2015-04-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.

Detailed description:

Arms: arm 1: Alisporivir (ALV) 300 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication arm 2: ALV 400 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication
Interventions: intervention 1: Alisporivir intervention 2: Ribavirin
Intervention descriptions: intervention 1: ALV 100 and 200 mg soft gel capsules administered orally intervention 2: RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose

Protocol documents:
Clinical trial NCT02098395
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2014-05-01; Completion date: 2015-04-01
Enrollment: 835 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Europe and North America. The purpose of the trial is to investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: liraglutide intervention 2: liraglutide intervention 3: liraglutide intervention 4: placebo intervention 5: placebo intervention 6: placebo
Intervention descriptions: intervention 1: Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily. intervention 2: Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily. intervention 3: Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily. intervention 4: Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily. intervention 5: Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily. intervention 6: Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.

Protocol documents:
Clinical trial NCT02100475
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2014-04-01; Completion date: 2015-04-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted globally. The aim of the trial is to compare sequential addition of insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and metformin and in need of further intensification.

This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/liraglutide intervention 2: insulin aspart
Intervention descriptions: intervention 1: Insulin degludec/liraglutide will be given subcutaneously (s.c., under the skin) once daily in combination with metformin.

Dose individually adjusted. intervention 2: Dose titration of insulin aspart will be based on the respective pre-meal(s) and bedtime SMPG measured daily.

Protocol documents:
Clinical trial NCT02114151
Conditions: Hepatitis C Virus Infection
Keywords: Hepatitis C Virus Infection Simeprevir Sofosbuvir HCV Cirrhosis
Sponsor: Janssen Infectious Diseases BVBA
Start date: 2014-04-01; Completion date: 2015-04-01
Enrollment: 103 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or treatment-experienced.

Detailed description:
This is a open-label (all people know the identity of the intervention), single arm, multicenter study. The study will consist of a screening phase up to 4 weeks, open-label treatment phase of 12 weeks, and post-treatment follow up phase up to 24 weeks after end of treatment. Approximately 100 participants will receive 150 mg simeprevir in combination with 400 mg sofosbuvir once dailyfor 12 weeks. Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examination. The maximum study duration for each participant will be approximately 40 weeks.

Arms: arm 1: 100 participants will receive 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Interventions: intervention 1: Simeprevir intervention 2: Sofosbuvir
Intervention descriptions: intervention 1: 100 participants will receive 1 capsule of 150 mg orally once daily for 12 weeks. intervention 2: 100 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks.

Protocol documents: