ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01536951
Conditions: Healthy Participants
Sponsor: Eli Lilly and Company
Start date: 2012-02-01; Completion date: 2013-05-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This will be a 2-part, randomized, participant- and investigator-blind study in healthy males and females.

Part A of this study is to determine a safe and tolerable single oral dose of LY3009104 that yields drug exposures slightly exceeding typical exposures anticipated from repeated administration of an efficacious dose to participants. The concentration of the drug in the blood stream will be measured and information about any side effects that may occur will also be collected.

Part B of this study is to evaluate the effect of LY3009104 on the electrical activity of the heart as measured by electrocardiogram (ECG) in relation to placebo following a single oral dose.

Detailed description:

Arms: arm 1: Placebo matching LY3009104 tablets in size and appearance will be administered orally in 1 out of 3 study periods in Part A and Part B. arm 2: Part A. Single escalating dose of up to 40 milligrams (mg) of LY3009104 administered orally in 2 out of 3 study periods separated by at least a 3 day wash-out period between each dose.

Part B. Single dose of LY3009104 determined in Part A administered orally in 1 out of 3 study periods separated by at least a 3 day wash-out period between each period. arm 3: Part B. 400 mg moxifloxacin will be administered orally in 1 out of 3 study periods separated by at least a 3 day wash-out period between each period.
Interventions: intervention 1: LY3009104 intervention 2: Placebo intervention 3: moxifloxacin
Intervention descriptions: intervention 1: administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol documents:
Clinical trial NCT01539135
Conditions: Respiratory Aspiration
Keywords: Aspiration, Respiratory
Sponsor: Medtronic - MITG
Start date: 2012-04-01; Completion date: 2013-05-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Surgical patients have an endotracheal tube inserted into their windpipe to help them breathe while under general anesthesia. These tubes have a "cuff" on the outside that is inflated in the trachea to help prevent fluids from leaking into the lungs. These cuffs come in different shapes and sizes. The TaperGuard endotracheal tube has a taper-shaped cuff that has been shown in animals to decrease the leakage of fluid past the cuff better than a traditional tube that has a barrel-shaped cuff. This study is designed to examine whether the use of the TaperGuard tube during surgery on humans decreases the amount of leakage past the cuff to a greater degree than the traditional barrel-shaped cuff. In addition, the study will investigate whether the use of the TaperGuard tube is associated with a decrease in respiratory complications often seen following surgery which may be related to fluid leaking past the cuff and into the lungs. It is thought that the use of the TaperGuard endotracheal tube will result in a decrease in fluid leakage past the cuff and that it will be associated with a decrease in respiratory complications during the 30 days after surgery.

Detailed description:
This study is designed to yield data on the intraoperative use of TaperGuard™endotracheal tubes and its potential influence on postoperative pulmonary complications and outcomes. The TaperGuard Basic tube has a taper-shaped cuff and has been shown, via bench and animal testing, to decrease microaspiration, which has been associated with respiratory difficulties. The intraoperative use of this tube (i.e. during short term intubation), and its impact on postoperative complications and outcomes has not been investigated. This study will determine whether the intraoperative use of the TaperGuard tube results in a decrease in microaspiration compared to the Hi-Lo endotracheal tube having a barrel-shaped cuff. Moreover, the relationship between a decrease in microaspiration and subsequent decrease in postoperative respiratory complications will be explored.

Arms: arm 1: Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure arm 2: TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure
Interventions: intervention 1: Methylene Blue
Intervention descriptions: intervention 1: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure

Protocol documents:
Clinical trial NCT01541735
Conditions: Type 2 Diabetes
Keywords: Diabetes Insulin Pantoprazole
Sponsor: Coordinación de Investigación en Salud, Mexico
Start date: 2012-01-01; Completion date: 2013-05-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the effect of pantoprazole on insulin secretion in drug-naïve patients with type 2 diabetes.

Detailed description:
Type 2 diabetes mellitus (T2DM) has become a major health problem worldwide with a high prevalence and related mortality, and a high rate of disability in the economically active. In Mexico the prevalence was 14.4% reported one of the highest in Latin America and estimated a cost of $ 778 million allocated for this disease in 2010, i.e., the tenth place worldwide. Within its pathophysiology are alterations in the secretion and insulin action, qualitatively and quantitatively, which implies a challenge for long-term metabolic control with the pharmacological arsenal available today. Since the function of pancreatic β cell decreases as a function of time and lack of control is essential metabolic find drugs that can preserve pancreatic cell mass and even promote neogenesis, with the aim of restoring the physiological secretion of insulin have been lost in the early stages of type 2 diabetes to achieve optimal glycemic control sustained over time to avoid complications and reduce the costs associated with the disease.

Have been evaluated in animal models with promising results Proton Pumps Inhibitors (PPI) for the restoration of glucose and the preservation of pancreatic cell function, including promoting its growth through increased levels of gastrin, which appears to act as a growth factor. However, at present no such mechanisms have been evaluated in humans, it would be interesting to assess the effect of administration of a PPI such as pantoprazole is, on the phases of insulin secretion in patients with T2DM recent diagnosis.

Material and Methods: Randomized, double-blind, placebo controlled clinical trial. Population: 14 drug-naive adults patients with T2DM and obesity. Hyperglycemic-hyperinsulinemic clamp to assess the phases of insulin secretion. Intervention for 45 days: pantoprazole 40mg or placebo.

Arms: arm 1: Placebo of calcined magnesia, capsules arm 2: The pantoprazole will be administered in 40mg capsules
Interventions: intervention 1: Pantoprazole intervention 2: placebo
Intervention descriptions: intervention 1: The pantoprazole will be administered in capsules of 40mg. The dose will be 1 capsule per day during 45 days. intervention 2: Placebo 40 mg dose.

Protocol documents:
Clinical trial NCT01562548
Conditions: Upper Back Pain
Keywords: upper back/neck/shoulder muscle spasm
Sponsor: GlaxoSmithKline
Start date: 2012-02-01; Completion date: 2013-05-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Explore the clinical efficacy of 7-day treatment regimens of guaifenesin in order to investigate the evidence that guaifenesin is an effective treatment for upper back/neck/shoulder muscle spasm/stiffness and pain.

Detailed description:

Arms: arm 1: Guaifenesin 1 tablet BID arm 2: Guaifenesin 2 tablets BID arm 3: Placebo 1 tablet BID arm 4: Placebo 2 tablets BID
Interventions: intervention 1: Guaifenesin intervention 2: Placebo
Intervention descriptions: intervention 1: high and low dose of Guaifenesin each given twice daily over a 4-day treatment period intervention 2: no active ingredient

Protocol documents:
Clinical trial NCT01565538
Conditions: Lung Cancer
Keywords: Cancer Non-small-cell lung cancer Adenocarcinoma EGFR gene mutation Chemotherapy Pemetrexed Erlotinib
Sponsor: Si-Yu Wang
Start date: 2008-12-01; Completion date: 2013-05-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Both pemetrexed and erlotinib are second-line treatment options for patients with advanced non-small cell lung cancer. It is controversial that whether it is necessary to detect epidermal growth factor receptor (EGFR) mutation status for the EGFR-targeted therapy after the failure of standard chemotherapy. The role of EGFR gene copy number as a predictive marker remains controversial. Therefore, we investigate the efficacy of erlotinib and pemetrexed as second-line therapy in treating in patients with EGFR wild-type and EGFR FISH-positive advanced lung adenocarcinoma.

Detailed description:
Standard first-line treatment for advanced-stage non-small cell lung cancer (NSCLC) usually consists of platinum-based doublet chemotherapy, but progression ultimately occurs for most patients. Second-line treatment options available to patients who suffer failure of first-line treatment include further chemotherapy (docetaxel and pemetrexed) or targeted therapy. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced NSCLC with EGFR mutation. High EGFR gene copy number was associated with great sensitivity and prolonged progression-free survival of NSCLC from EGFR-TKIs. This phase II study was designed to assess the efficacy and safety of erlotinib compared with pemetrexed as second-line treatment for EGFR wild-type and EGFR FISH-positive lung adenocarcinoma.

Arms: arm 1: Erlotinib at the dose of 150 mg orally once a day continually until progression. arm 2: Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.
Interventions: intervention 1: Erlotinib intervention 2: Pemetrexed
Intervention descriptions: intervention 1: 150 mg Given orally intervention 2: 500mg/m2 Given IV

Protocol documents:
Clinical trial NCT01576549
Conditions: Rheumatoid Arthritis
Sponsor: Eli Lilly and Company
Start date: 2012-05-01; Completion date: 2013-05-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will investigate how LY2127399 works in participants with rheumatoid arthritis (RA) who are not adequately responding to methotrexate. Participants will receive LY2127399 via an injection(s) under the skin at 4 week intervals for up to 52 weeks. Key study procedures include biopsies of the lining of an inflamed joint and blood tests to measure RA activity.

Detailed description:

Arms: arm 1: LY2127399 given subcutaneously (SC) at 240 milligrams (mg) as a loading dose in the first week followed by 120 mg SC every 4 weeks for up to 52 weeks.
Interventions: intervention 1: LY2127399
Intervention descriptions: intervention 1: Administered subcutaneously

Protocol documents:
Clinical trial NCT01600222
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2012-05-01; Completion date: 2013-05-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A Phase 2 Maximal Use Systemic Exposure (MUSE) study evaluating the safety and efficacy of LEO 90100 used once daily in subjects with extensive psoriasis vulgaris.

Detailed description:
The purpose of the present study is to assess the systemic safety of LEO 90100. Although LEO 90100 contains the same active ingredients in the same concentration as DAIVOBET/DOVOBET/TACLONEX ointment, the degree of absorption of the active ingredients from the new formulation may differ. Systemic safety will be assessed through the effect of LEO 90100 on calcium metabolism and HPA axis function under maximum use conditions (i.e., in subjects with very extensive psoriasis on the trunk, limbs and scalp, using up to 120g per week of LEO 90100 for up to 4 weeks). Data from this study, together with the measurements of albumin-corrected serum calcium and the calcium:creatinine ratio in spot urine samples in the planned phase 2 and 3 studies in the development program for LEO 90100, are expected to provide adequate information with respect to the systemic safety of LEO 90100.

Arms: arm 1: None
Interventions: intervention 1: LEO 90100
Intervention descriptions: intervention 1: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)

Protocol documents:
Clinical trial NCT01603121
Conditions: Type 1 Diabetes Mellitus
Keywords: lisofylline
Sponsor: Eastern Virginia Medical School
Start date: 2012-02-01; Completion date: 2013-05-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary goal of the study is to investigate the safety and tolerability of the investigational drug lisofylline, when administered under the skin or in the vein, in people with type 1 diabetes. A second aim is to determine how much drug is available in the blood after injection under the skin, compared to injection in the vein.

Detailed description:
This is an open-label, randomized, crossover study in subjects with type 1 diabetes. There are two treatment periods separated by approximately one week. One treatment will consist of a 10 hour subcutaneous infusion of lisofylline, and the other treatment will consist of a 10 hour intravenous infusion of lisofylline.

Eligible subjects will be admitted to the Infusion Center the morning of dosing (Day 1, Day 7) during each treatment period, receive their assigned dose of study drug on Day 1 and Day 7, and will remain confined to the Infusion Center until approximately 3 hours following the start of study drug administration for the remaining blood draws. The subjects will then be escorted to the Sleep Center of Eastern Virginia Medical School for an overnight stay during which time their heart rate and oxygen saturation will be monitored by pulse oximetry. The next morning the subjects will return to the Infusion Center for a final blood draw and physical examination. The Infusion Center and the Sleep Disorders Center are both within Sentara Norfolk General Hospital.

All subjects will be assigned to a treatment sequence according to a randomization schedule.

Arms: arm 1: Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period arm 2: Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period
Interventions: intervention 1: Lisofylline
Intervention descriptions: intervention 1: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart.

Protocol documents:
Clinical trial NCT01620060
Conditions: Schizophrenia Autism
Keywords: Schizophrenia autism bipolar Lurasidone Latuda
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2012-06-01; Completion date: 2013-05-01
Enrollment: 105 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 1, open-label, multicenter, single and multiple ascending lurasidone dose study in subjects from 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric disorders.

Detailed description:
To characterize lurasidone PK profile following single and multiple oral doses of 20, 40,80, 120 or 160 mg/day lurasidone in the targeted pediatric/adolescent population (6-17 years old)with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder or other psychiatric disorders. Data from this study will be used to recommend pediatric doses that result in comparable exposures to those observed in currently approved adult doses of Latuda® (40, 80, 120 and 160 mg/day) in subsequent efficacy and safety studies.

Arms: arm 1: Lurasidone 20, 40, 80, 120 or 160 mg/day
Interventions: intervention 1: Lurasidone
Intervention descriptions: intervention 1: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days

Protocol documents:
Clinical trial NCT01639599
Conditions: Gynecological Disease
Keywords: non-smoker female IV PCA patient-controlled analgesia
Sponsor: The Catholic University of Korea
Start date: 2012-03-01; Completion date: 2013-05-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Low-dose haloperidol is known to be effective for the treatment of postoperative nausea and vomiting (PONV). However, precise dose-response studies have not been completed, especially in patients at high risk for PONV who require combination therapy. This study sought to identify the optimal dose of haloperidol that could be combined with dexamethasone without adverse effects in high-risk PONV patients receiving intravenous patient-controlled anesthesia (IV PCA) after gynecological laparoscopic surgery.

Detailed description:
Female adults with three established PONV risk factors based on Apfel's score were randomised into one of three study groups. At the end of anaesthesia, groups H0, H1, and H2 were given intravenous (IV) saline, haloperidol 1 mg, and haloperidol 2 mg, respectively. All patients were given dexamethasone during the induction of anaesthesia. The overall early (0-2 h) and late (2-24 h) incidences of nausea, vomiting, rescue anti-emetic administration, pain, and adverse effects (cardiac arrhythmias and extrapyramidal effects) were assessed postoperatively. The sedation score was recorded in the postanaesthesia care unit (PACU).

Arms: arm 1: dexamethasone 5mg iv during anesthesia induction arm 2: dexamethasone 5mg iv during anesthesia induction \& haloperidol 1mg iv 30 min before end of anesthesia arm 3: dexamethasone 5mg iv during anesthesia induction \& haloperidol 2mg iv 30 min before end of anesthesia
Interventions: intervention 1: Dexamethasone iv injection intervention 2: Dexamethasone, haloperidol intervention 3: Dexamethasone, haloperidol
Intervention descriptions: intervention 1: Dexamethasone 5mg iv during anesthesia induction intervention 2: dexamethasone + haloperidol 1mg intervention 3: Active Comparator: dexamethasone + haloperidol 2mg

Protocol documents:
Clinical trial NCT01652495
Conditions: Tendinopathy Adrenal Insufficiency
Keywords: rotatory cuff calcific tendonitis corticosteroids US guided percutaneous treatment methylprednisolone triamcinolone hypothalamus pituitary adrenal axis
Sponsor: Istituto Ortopedico Rizzoli
Start date: 2012-03-01; Completion date: 2013-05-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and effects on the hypothalamus-pituitary-adrenal axis of a single intrabursal injection of two different types of corticosteroids (methylprednisolone and triamcinolone) in patients with calcific shoulder tendinopathy.

Detailed description:
Rotator cuff calcific tendonitis is a common disease, mainly affecting women aged 30 to 50 years old. It is associated to severe pain and impotence. US-guided percutaneous treatment is considered the gold standard treatment with the aim to destroy and wash out shoulder's calcification, responsible for inflammation, pain and functional limitation. Corticosteroids are injected in the subacromial-subdeltoid bursa at the end of the procedure to facilitate the prompt pain relief and functional recovery. Although corticosteroids represent the most powerful drugs to reduce inflammation and pain, their use is associated to important side effects, mainly the suppression of the hypothalamus-pituitary-axis (HPA). At the same time, no standardized protocols exist regarding the best type and dose of corticosteroid to be injected in association to the above mentioned treatment, nor data evaluating the exact duration of HPA suppression following a single intrabursal injection of corticosteroids.

40 patients affected by rotator cuff calcific tendonitis will be enrolled in the study and randomly assigned to two groups: one group (20 patients) will be treated with a single intrabursal injection of 40 mg of methylprednisolone; the other group (20 patients) will be treated with a single intrabursal injection of 40 mg of triamcinolone.

All patients will be tested at time 0 (morning before treatment) and at 1, 7, 15, 30 and 45 days after the injection, using clinical, laboratory and US parameters in order to compare the efficacy and safety of the two drugs.

Arms: arm 1: Single intrabursal injection of methylprednisolone acetate arm 2: Single intrabursal injection of Triamcinolone acetonide
Interventions: intervention 1: methylprednisolone acetate intervention 2: Triamcinolone Acetonide
Intervention descriptions: intervention 1: Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate intervention 2: Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide

Protocol documents:
Clinical trial NCT01658579
Conditions: Type 1 Diabetes Mellitus
Sponsor: Sanofi
Start date: 2012-08-01; Completion date: 2013-05-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

* To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus

Secondary Objectives:

* To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening
* To compare the incidence and frequency of hypoglycemic episodes
* To assess the safety and tolerability of the new formulation of insulin glargine

Detailed description:
* Up to 4-week screening period;
* 16-week open-label comparative efficacy and safety treatment period;
* 4-week post-treatment safety follow-up period.

Arms: arm 1: HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 millimole per liter (mmol/L). arm 2: HOE901-U300 (new insulin glargine 300 U/mL) SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L. arm 3: Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L. arm 4: Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L.
Interventions: intervention 1: HOE901-U300 (new formulation of insulin glargine) intervention 2: Lantus (insulin glargine)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: