ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01472757
Conditions: Asthma
Sponsor: Vectura Limited
Start date: 2011-10-01; Completion date: 2013-05-01
Enrollment: 374 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the clinical efficacy of three doses of VR506 delivered via a new dry powder inhaler for the treatment of asthma.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: VR506 intervention 2: Placebo
Intervention descriptions: intervention 1: VR506 inhalation powder delivered via a new dry powder inhaler intervention 2: Placebo delivered via a new dry powder inhaler

Protocol documents:
Clinical trial NCT01486043
Conditions: Acute Lymphoblastic Leukemia Hyperglycemia Insulin Resistance Diabetes Mellitus
Keywords: Induction chemotherapy Transient hyperglycemia Metformin Acute lymphoblastic leukemia Insulin resistance Hyperglycemia Insulin
Sponsor: Children's Hospital Los Angeles
Start date: 2011-12-01; Completion date: 2013-05-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether metformin is an effective adjunctive treatment for transient hyperglycemia in patients with acute lymphoblastic leukemia (ALL) undergoing induction chemotherapy

Detailed description:
ALL is the most common childhood cancer, representing one fourth of all cancers diagnosed under the age of 15 years. One of the most common side effects of ALL chemotherapy is transient hyperglycemia. Patients that develop this complication require treatment with insulin via injections to prevent severe medical complications such as dehydration, weight loss, ketoacidosis and life-threatening infections. Although insulin therapy is effective, it adds a lot of physical and psychological burden to patients because multiple daily insulin injections are required to achieve adequate blood glucose control.

In this pilot study, investigators aim to examine the effectiveness of metformin as an adjunctive treatment for transient hyperglycemia. Investigators will be comparing two groups of subjects (up to 40 subjects per group). Patients in the treatment group will be prospectively recruited, and they will be treated with metformin in addition to insulin therapy. Investigators will compare the treatment group to a historical control group acquired via chart review. These patients will have been treated with insulin alone.

Statistical comparison will be made between the two groups in terms of the length of insulin treatment, the total daily dose of insulin required, number of insulin injections, hemoglobin A1c level (measure of glycemic control over preceding 8- 12 weeks), and fructosamine level (measure of glycemic control over preceding 2-3 weeks).

Investigators hypothesize that the use of metformin will result in fewer numbers of insulin injections and fewer days of insulin therapy.

Arms: arm 1: Up to 30-40 patients will be in the prospectively recruited treatment group, which will receive both metformin and insulin therapy for transient hyperglycemia
Interventions: intervention 1: Metformin
Intervention descriptions: intervention 1: All subjects will be started on metformin 500 mg orally twice daily. The dose will be increased by 500 mg weekly as tolerated until subjects' blood glucoses are well controlled or until the patient reaches metformin 1000 mg PO BID.

Protocol documents:
Clinical trial NCT01491633
Conditions: Squamous Cell Lung Cancer
Keywords: Lung cancer NSCLC Stage IIIB Stage IV
Sponsor: Dana-Farber Cancer Institute
Start date: 2011-09-01; Completion date: 2013-05-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Dasatinib is a drug that has been shown to stop some cancer cells from growing. This drug has been used in treatment for other types of cancer and information from other research studies suggests that dasatinib may help to stop squamous cell lung cancer from growing, especially in individuals whose tumor has a mutation in the DDR2 gene.

Advanced squamous cell lung cancer (SqCC) carries a poor prognosis and new therapeutic targets are needed. Several studies have examined dasatinib in NSCLC; these report significant toxicities, but also responses in patients found to harbor mutations in DDR2 or BRAF.

An open-label phase II trial with dasatinib was carried out to determine the response rates in patients with SqCC who had previously failed standard chemotherapy and to correlate responses with patient genotype.

Detailed description:
Dasatinib will be taken orally, daily in cycles of 28 days.

On the first day of study treatment and at 2 weeks, 4 weeks and then every 4 weeks subjects will have the following:

* Medical history and clinical exam
* Safety blood tests
* Measurement of Performance Status
* Review of pill log
* CT scans will be done every 8 weeks.

In this research study, the investigators are looking at how well dasatinib works in treating squamous cell lung cancer.

Dasatinib administered at 140mg per day for the treatment of advanced SqCC of the lung is associated with excess adverse events, similar to other studies, so is not recommended in unselected patients. Further work to identify patients likely to benefit from dasatinib and in managing dasatinib-related toxicities is needed.

Arms: arm 1: Dasatinib 140 mg by mouth each day
Interventions: intervention 1: Dasatinib
Intervention descriptions: intervention 1: 140 mg orally, daily in 28 day cycles

Protocol documents:
Clinical trial NCT01496430
Conditions: Hypertension Diabetes
Keywords: Drug Therapy Hypertension and Diabetes
Sponsor: Takeda
Start date: 2012-01-01; Completion date: 2013-05-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in stage 1 hypertensive, type 2 diabetes mellitus (T2DM) participants whose glycemic control was inadequate on metformin alone.

Detailed description:
The study included a Screening Period of up to 4 weeks, which coincided with a 2-week single-blind, placebo Run-in Period, a 24 week Treatment Period, and a 2-week Follow-up Period. The duration of the study was approximately 30 weeks. The planned number of participants (n=450) was not reached; actual enrollment consisted of 105 particpants. Due to low enrollment this study was terminated early by Takeda.

Arms: arm 1: Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks. arm 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks. arm 3: Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
Interventions: intervention 1: Placebo intervention 2: Azilsartan medoxomil intervention 3: Azilsartan medoxomil
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01506362
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis IBD
Sponsor: BioLineRx, Ltd.
Start date: 2012-03-01; Completion date: 2013-05-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of the proposed study is to determine whether BL-7040 demonstrates clinical efficacy in patients with inflammatory bowel disease (IBD).

Detailed description:

Arms: arm 1: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.
Interventions: intervention 1: BL-7040
Intervention descriptions: intervention 1: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.

Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.

BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days.

Protocol documents:
Clinical trial NCT01510145
Conditions: Open-angle Glaucoma Ocular Hypertension
Keywords: Glaucoma Open-angle glaucoma Ocular hypertension Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Travoprost Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions
Sponsor: Alcon Research
Start date: 2012-02-01; Completion date: 2013-05-01
Enrollment: 191 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® solution without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% ophthalmic solution monotherapy in subjects with open-angle glaucoma or ocular hypertension due to tolerability issues.

Detailed description:

Arms: arm 1: Travoprost 0.004% BAK-free, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
Interventions: intervention 1: Travoprost 0.004% BAK-free
Intervention descriptions: intervention 1: Containing Polyquad (PQ) preservative

Protocol documents:
Clinical trial NCT01511939
Conditions: Osteoarthritis of the Knee Coagulopathy
Keywords: Knee pain Anticoagulant Warfarin Dabigatran Clopidogrel Aspirin Topical NSAID Osteoarthritis
Sponsor: Nathan Wei, MD, FACP, FACR:
Start date: 2012-02-01; Completion date: 2013-05-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if using a topical nonsteroidal antiinflammatory drug (Pennsaid) to treat osteoarthritis knee pain will affect coagulation values in patients who are also taking anticoagulant or antithrombotic medications.

Detailed description:
Open-label active treatment Phase III study of Pennsaid (diclofenac sodium 1.5% topical solution) to determine the effects on coagulation parameters in patients who are equal to or greater than 55 years of age with moderate to severe osteoarthritis knee pain and who are also taking warfarin, dabigatran, or aspirin and/or clopidogrel.

Arms: arm 1: Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months arm 2: Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months arm 3: Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months
Interventions: intervention 1: Pennsaid
Intervention descriptions: intervention 1: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period.

Protocol documents:
Clinical trial NCT01512745
Conditions: Advanced or Metastatic Gastric Cancer
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Start date: 2011-01-01; Completion date: 2013-05-01
Enrollment: 267 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival or overall survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: apatinib intervention 2: placebo
Intervention descriptions: intervention 1: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent intervention 2: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

Protocol documents:
Clinical trial NCT01517412
Conditions: Type 2 Diabetes Mellitus
Sponsor: Sanofi
Start date: 2012-02-01; Completion date: 2013-05-01
Enrollment: 451 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

\- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24)

Secondary Objective:

* To assess the effect of the 2 lixisenatide regimens on:

  * The percentage of participants who reached the target of HbA1c \< 7% or ≤ 6.5% at Week 24
  * Fasting Plasma Glucose (FPG)
  * 7-point Self-Monitored Plasma Glucose (SMPG) profiles
  * Body weight
* To assess the safety and tolerability of the 2 lixisenatide regimens

Detailed description:
The maximum study duration was 28 weeks per participant, including a 24-week randomized treatment period.

Arms: arm 1: Lixisenatide 10 mcg once daily (QD) within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24. arm 2: Lixisenatide 10 mcg QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Self-injector pen device (OptiClik®) intervention 3: Metformin
Intervention descriptions: intervention 1: Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous intervention 2: None intervention 3: To be kept at stable dose (≥1.5 g/day) throughout the study.

Protocol documents:
Clinical trial NCT01519427
Conditions: Recurrent Melanoma Stage IIIA Melanoma Stage IIIB Melanoma Stage IIIC Melanoma Stage IV Melanoma
Sponsor: National Cancer Institute (NCI)
Start date: 2012-01-01; Completion date: 2013-05-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well selumetinib and Akt inhibitor MK2206 works in treating patients with stage III or stage IV melanoma who failed prior therapy with vemurafenib or dabrafenib. Selumetinib and Akt inhibitor MK2206 stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether giving selumetinib and Akt inhibitor MK2206 together is an effective treatment for advanced melanoma.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the frequency of objective clinical responses by RECIST 1.1 for these melanoma patients who have previously progressed on selective BRAF inhibitors when treated with MEK inhibitor, AZD6244 hydrogen sulfate plus Akt inhibitor, MK-2206.

II. To further characterize toxicities of both regimens in these patients who have progressed after BRAF inhibitor therapy.

SECONDARY OBJECTIVES:

I. With required fresh pretreatment biopsies on all patients, we plan to characterize the molecular state (genetic and proteomic) associated with BRAF inhibitor resistance. This may include an analysis of pathway activation, PI3/Akt or MAP kinase pathway; loss of expression of PTEN, secondary mutations in BRAF, other mutations in the MAP kinase pathway (NRAS, KRAS, HRAS, CRAF, MEK), activation of other RTKs (amplification, over expression, phosphorylation).

OUTLINE:

Patients receive selumetinib orally (PO) twice daily (BID) on days 1-21 and Akt inhibitor MK2206 PO once weekly.

After completion of study treatment, patients are followed up every 12 weeks.

Arms: arm 1: Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
Interventions: intervention 1: Akt inhibitor MK2206 intervention 2: selumetinib intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01523366
Conditions: Stable Coronary Artery Disease
Keywords: Stable Coronary Artery Disease, CAD
Sponsor: AstraZeneca
Start date: 2012-04-01; Completion date: 2013-05-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic patients with stable coronary artery disease.

Detailed description:
A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor versus Clopidogrel in Hispanic Patients with Stable Coronary Artery Disease

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ticagrelor intervention 2: Clopidogrel
Intervention descriptions: intervention 1: Min - 90mg/Max - 180mg tablets (loading dose) intervention 2: 75mg (once daily)/Max - 600mg tablets (loading dose)

Protocol documents:
Clinical trial NCT01527513
Conditions: Partial Epilepsy
Keywords: Partial Epilepsy eslicarbazepine acetate Children
Sponsor: Bial - Portela C S.A.
Start date: 2010-08-01; Completion date: 2013-05-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the effects of eslicarbazepine acetate on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures.

Detailed description:
This will be a 2-part multicentre study in approximately 117 patients. Part I of the study will consist of a 4-week prospective observational baseline period, a 12-week double-blind period (4-week up-titration and 8-week maintenance), and a tapering-off period.

After the screening visit (V1), patients will enter the baseline period. At the end of the baseline period (V2), eligible patients will be randomised in a ratio of 2:1 to receive double-blind treatment with Eslicarbazepine acetate or Placebo in addition to concomitant therapy with 1 or 2 Anti-Epileptic Drugs (AEDs). Concomitant AED therapy will be kept stable during the whole study.

Initial dose of the study treatment will be 10 mg/kg/day. After 2-weeks on 10 mg/kg/day, the dose will be up-titrated to 20 mg/kg/day (maximum 1200 mg/day). After 2 weeks on 20 mg/kg/day, dose will be up-titrated to 30 mg/kg/day (maximum 1200 mg/day) and patients will receive this dose for 8 weeks. If intolerable adverse events (AEs) occur, the patient can be down-titrated to the previous dose (only 1 down-titration step will be allowed) or discontinued. After the 8-week maintenance period, the study treatment will be tapered off in 10 mg/kg/day 2 week steps. However, if a patient experiences an increase in seizure frequency (e.g. more than 100% increase vs. baseline) during tapering-off, the patient can proceed directly to the open-label part of the study (Part II).

After completion of the last 2-week 10 mg/kg/day step, patients will have the option to enter a 1 year open-label treatment (Part II) with Eslicarbazepine acetate (up to 30 mg/kg/day, maximum 1200 mg/day), or will have a 4 week observational follow-up period.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Eslicarbazepine acetate (BIA 2-093) intervention 2: Placebo
Intervention descriptions: intervention 1: Eslicarbazepine acetate (ESL) tablets 200 mg and the matching placebo will be supplied. Treatments will be administered by oral route, once-daily, in the evening. The dose will be rounded to the nearest 100 mg unit. Half tablets may be used for dose adjustment if necessary. intervention 2: Treatments will be administered by oral route, once-daily, in the evening.

Protocol documents:
Clinical trial NCT01534520
Conditions: Pain
Keywords: Intrauterine Device Pain Lidocaine
Sponsor: University of Pittsburgh
Start date: 2012-06-01; Completion date: 2013-05-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate if self-inserted intravaginal 2% lidocaine gel is effective at decreasing pain during intrauterine device insertion in nulliparous women.

Detailed description:
Intrauterine devices (IUDs) are among the most effective forms of reversible contraception. Numerous studies demonstrate their safety and efficacy in nulliparous women, however, uptake of IUDs in this group is low. One of the major barriers to women obtaining IUDs is fear of pain during insertion, as studies do demonstrate that nulliparous women experience more pain than parous women during IUD insertion. Studies evaluating various methods for pain control during IUD insertion have shown conflicting results, leaving the question unanswered as to what is the best method to decrease pain during IUD insertion.

This study aims to evaluate a novel approach to pain control by having women self-insert lidocaine gel into the vagina at least 5 minutes prior to IUD insertion. This will overcome some of the barriers from other studies where there may not have been ample time for the lidocaine to take effect, while at the same time eliminating the need for women to have multiple speculum exams. Although this is a novel approach to administering an anesthetic, we believe women will be interested in any intervention that may potentially alleviate pain during IUD insertion.

If this study does demonstrate that pain is decreased with self-inserted lidocaine compared to placebo gel, this will potentially eliminate one large barrier to nulliparous women receiving IUDs. Increased uptake of highly effective contraception in nulliparous women is just one of the many steps necessary towards decreasing unintended pregnancy.

Arms: arm 1: Intravaginal insertion of 4mL of 2% lidocaine gel arm 2: Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)
Interventions: intervention 1: Lidocaine intervention 2: Placebo
Intervention descriptions: intervention 1: Intravaginal insertion of 4mL 2% lidocaine gel intervention 2: KY Jelly

Protocol documents:
Clinical trial NCT01535599
Conditions: Acute Otitis Externa
Keywords: Acute Otitis Externa
Sponsor: Alcon Research
Start date: 2012-03-01; Completion date: 2013-05-01
Enrollment: 768 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to demonstrate the superiority of AL-60371, 0.3% Otic Suspension relative to AL-60371 Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).

Detailed description:
Patients were evaluated for safety and efficacy during the visits conducted at Day 3 (on-therapy), Day 8 (end-of-therapy), and Day 11 (TOC). Patients or parents/legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear pain medication use, and the impact of ear pain on sleep and other daily activities.

Arms: arm 1: AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days arm 2: AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
Interventions: intervention 1: AL-60371, 0.3% Otic Suspension intervention 2: AL-60371 Vehicle
Intervention descriptions: intervention 1: None intervention 2: Inactive ingredients used as a placebo comparator

Protocol documents: