ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01347580
Conditions: Myocardial Infarction Segment Elevation Myocardial Infarction (STEMI)
Keywords: Heart attack heart disease cardiovascular disease stroke reperfusion pre hospital settings ticagrelor Percutaneous Coronary Intervention
Sponsor: AstraZeneca
Start date: 2011-09-01; Completion date: 2013-11-01
Enrollment: 1875 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to determine whether initiation of ticagrelor as early as in the ambulance setting leads to a rapid reperfusion of the infarct-related artery therefore facilitating the Percutaneous Coronary Intervention (PCI) and optimizing the outcome for the patient.

The study will assess the efficacy and safety of pre-hospital compared to in-hospital administration of ticagrelor in co-administration with aspirin, on restoring the blood flow in the occluded heart artery and improving the myocardial perfusion in patients suffering from myocardial infarction and planned to have a PCI. Patients can be randomised in either one of the 2 arms:

re-hospital ticagrelor arm: Patients will receive a loading dose of 180 mg ticagrelor for the pre-hospital administration and placebo for in-hospital administration.

or In-hospital ticagrelor arm: Patients will receive a placebo for pre-hospital administration and 180 mg ticagrelor loading dose for in-hospital administration.

Patients are initially managed by ambulance physician/personnel in pre hospital settings. They are then transferred into a Catheterization room to undergo a PCI.

After the administration of the loading dose of ticagrelor (double blind), patients will continue on ticagrelor 90 mg bid and be followed in study for 30 days post randomisation.

Detailed description:

Arms: arm 1: Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days. arm 2: Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
Interventions: intervention 1: Ticagrelor intervention 2: Placebo
Intervention descriptions: intervention 1: Oral Ticagrelor loading dose (180 mg) followed by matching placebo intervention 2: Placebo followed by oral Ticagrelor loading dose (180 mg)

Protocol documents:
Clinical trial NCT01415960
Conditions: Prostate Cancer
Keywords: Prostate Cancer androgen deprivation therapy. Leuprolide Acetate Depot Formulation Pharmacokinetics testosterone serum luteinizing hormone follicle-stimulating hormone prostate-specific antigen
Sponsor: GP-Pharm
Start date: 2011-09-01; Completion date: 2013-11-01
Enrollment: 163 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Some patients with prostate cancer benefit from androgen deprivation therapy which reduces levels of testosterone. Leuprolide is a synthetic Luteinizing hormone releasing hormone (LHRH) analogue which upon administration can decrease testosterone levels to ≤0.5 ng/mL. Leuprolide Acetate 22.5 mg Depot is a microencapsulated formulation of leuprolide which is released slowly over time and effectively reduces testosterone levels in many patients to ≤0.5 ng/mL for up to three months. In this study Leuprolide acetate 22.5 mg Depot will be administered by intramuscular injection twice over a period of 6 months. The proportion of patients with testosterone ≤0.5 ng/mL evaluated over a period of 168 days.

Detailed description:
This in an open-label, multicenter, multiple-dose investigation of 2 doses of leuprolide acetate 22.5 mg administered with a 3-month interval to patients with histologically proven carcinoma of prostate who might benefit from medical androgen deprivation therapy. A total of up to 160 male patients will receive their first single intramuscular injection of leuprolide acetate 22.5 mg on Day 0 (after baseline assessment) and then after 3 months (Day 84). The study duration will be 6 months. Thirty(30) patients will be screened per protocol and enrolled at selected centers to form the PK cohort. The PK/PD analysis will be performed using plasma specimens from the first 20 of 30 patients enrolled in the study (and included in the PK/PD cohort). Patients not belonging to the PK cohort will be screened and enrolled per protocol and will follow the same study schedule as those enrolled in the PK portion of the study, except they will provide only sparse PK sampling.

Arms: arm 1: Leuprolide acetate 22.5 mg depot administered twice, 3 months apart
Interventions: intervention 1: Leuprolide acetate 22.5 mg depot, GP-Pharm SA
Intervention descriptions: intervention 1: Administered by im injection, twice during the study, three months apart

Protocol documents:
Clinical trial NCT01419275
Conditions: Cerebrovascular Accident Moyamoya Disease
Sponsor: Stanford University
Start date: 2009-04-01; Completion date: 2013-11-01
Enrollment: 126 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke patients

Detailed description:
In the early hours following large vessel occlusion, the ultimate severity of the stroke is largely determined by the ability of collateral flow networks to supply blood to ischemic tissue via circuitous routes that bypass the proximal clot. Robust collateral flow can improve response to thrombolytic therapy and decrease the risk of intracranial hemorrhage. Despite their central importance, collaterals during acute stroke are poorly understood, largely because assessment has required an invasive imaging test, cerebral angiography. This proposal assesses whether a noncontrast MRI perfusion technique, called arterial spin labeling (ASL), can yield important information about collateral flow.

Arms: arm 1: Approximately 60 Moyamoya patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow. arm 2: Approximately 60 acute stroke patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow. arm 3: Approximately 30 healthy participants will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow. arm 4: Approximately 60 participants with diagnosis unspecified will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.
Interventions: intervention 1: Xenon contrast agent intervention 2: Magnetic Resonance Imaging
Intervention descriptions: intervention 1: None intervention 2: Arterial spin label sequence for the purpose of measuring collateral flow

Protocol documents:
Clinical trial NCT01424813
Conditions: Asthma
Keywords: Asthma dry powder inhaler short-acting beta2-agonist SABA bronchoconstriction bronchodilation bronchodilator metered dose inhaler
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2012-12-01; Completion date: 2013-11-01
Enrollment: 158 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: Albuterol Spiromax® or placebo.

Detailed description:

Arms: arm 1: Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks. arm 2: Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
Interventions: intervention 1: Placebo MDPI intervention 2: Albuterol MDPI
Intervention descriptions: intervention 1: Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks. intervention 2: Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.

Protocol documents:
Clinical trial NCT01425463
Conditions: Iron Deficiency Anemia
Keywords: Ferrous (II) Glycine Sulphate Complex Polyferose Ferro Sanol duodenal Niferex Iron Deficiency Anemia
Sponsor: Sanol GmbH
Start date: 2011-03-01; Completion date: 2013-11-01
Enrollment: 256 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of 12 weeks treatment with Ferrous (II) Glycine Sulphate Complex in comparison to Polyferose capsules in Chinese subjects with manifest Iron Deficiency Anemia.

Detailed description:

Arms: arm 1: Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose. arm 2: Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.
Interventions: intervention 1: Ferrous (II) Glycine Sulphate Complex intervention 2: Polyferose intervention 3: Placebo to Ferrous (II) Glycine Sulphate Complex intervention 4: Placebo to Polyferose
Intervention descriptions: intervention 1: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).

Administered orally with water. intervention 2: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).

Administered orally with water. intervention 3: Administered orally with water. intervention 4: Administered orally with water.

Protocol documents:
Clinical trial NCT01431287
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2011-09-01; Completion date: 2013-11-01
Enrollment: 2539 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with COPD.

Detailed description:

Arms: arm 1: Once daily 2 puffs solution for inhalation Respimat arm 2: Once daily 2 puffs solution for inhalation Respimat arm 3: Once daily 2 puffs solution for inhalation Respimat arm 4: Once daily 2 puffs solution for inhalation Respimat arm 5: Once daily 2 puffs solution for inhalation Respimat
Interventions: intervention 1: tiotropium + olodaterol intervention 2: tiotropium + olodaterol intervention 3: tiotropium intervention 4: tiotropium intervention 5: olodaterol intervention 6: Respimat
Intervention descriptions: intervention 1: fixed dose combination intervention 2: fixed dose combination intervention 3: low dose or high dose intervention 4: low dose or high dose intervention 5: one dose only intervention 6: Respimat inhaler

Protocol documents:
Clinical trial NCT01458015
Conditions: Peripheral Neuropathy
Keywords: QST (quantitative sensory testing) neuropathic pain tapentadol pr oxycodone
Sponsor: University Hospital Schleswig-Holstein
Start date: 2011-10-01; Completion date: 2013-11-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to elucidate whether the additional mechanism of analgesia, i.e. reuptake inhibition of norepinephrine, of tapentadol leads to a change in different pain signs and symptoms in comparison to oxycodone.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: tapentadol, oxycodone
Intervention descriptions: intervention 1: tapentadol pr 100-500 mg oxycodone cr 20-120mg

Protocol documents:
Clinical trial NCT01458340
Conditions: Attention-Deficit/Hyperactivity Disorder ADHD
Keywords: Adult ADHD Attention-Deficit/Hyperactivity Disorder
Sponsor: Theravance Biopharma
Start date: 2011-12-01; Completion date: 2013-11-01
Enrollment: 295 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be evaluated in adult males with ADHD.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: TD-9855 intervention 2: TD-9855 intervention 3: Placebo
Intervention descriptions: intervention 1: Once daily intervention 2: Once daily intervention 3: Once daily

Protocol documents:
Clinical trial NCT01465230
Conditions: Chronic Lymphocytic Leukemia
Keywords: chronic lymphocytic leukemia maintenance therapy
Sponsor: Yale University
Start date: 2012-03-01; Completion date: 2013-11-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will determine whether or not Lenalidomide improves effectiveness of treatment for chronic lymphocytic leukemia following chemotherapy with two drugs commonly used to treat the disease (bendamustine and rituximab).

Detailed description:

Arms: arm 1: Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Interventions: intervention 1: Maintenance lenalidomide
Intervention descriptions: intervention 1: Daily maintenance treatment, oral lenalidomide

Protocol documents:
Clinical trial NCT01467583
Conditions: Venous Thromboembolism
Keywords: Fondaparinux Renal Failure Critically Ill
Sponsor: Wayne State University
Start date: 2011-11-01; Completion date: 2013-11-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine whether a dose-adjusted prophylaxis fondaparinux regimen of 2.5 milligrams (mg) subcutaneously administered every (q) 48 hours (hr) in patients with renal failure achieves peak and trough levels similar to patients with normal renal function, and protects patients from developing venous thromboembolism (VTE). Our hypothesis is that a dose-adjusted fondaparinux regimen, which extends the dosing interval from q24 to q48 hr, in patients with estimated creatinine clearance of \< 30 ml/min, will be safe and effective.

Detailed description:
We will be studying fondaparinux 2.5 mg subcutaneously every 48 hr in three distinct patient groups: 1) Acute kidney failure without hemodialysis, 2) Acute kidney failure (AKI) with intermittent hemodialysis (IHD) and 3) Acute renal failure with continuous renal replacement therapy (CRRT). All patients will be assessed for efficacy of the dose. Efficacy will be assessed by following clinically for any evidence of VTE, either deep venous thrombosis (DVT) or pulmonary embolism. In addition, lower extremity duplex studies will be performed at baseline and at the end of the study period to assess for DVT.

Secondary objectives will be safety and accumulation. Safety will be determined by assessment of clinically significant bleeding, defined as a drop in Hgb of \> 2 grams (gm) in 24 hr, or the need for red blood cell transfusion related to bleeding. Accumulation may occur in renal failure and will be studied throughout the intensive care unit (ICU) stay through reevaluation of levels over time.

Arms: arm 1: These are patients with renal failure, on intermittent hemodialysis (IHD), receiving fondaparinux 2.5 mg subcutaneously every 48 hours arm 2: These are patients with renal failure, either acute or chronic, on continuous renal replacement therapy (CRRT) receiving fondaparinux 2.5 mg subcutaneously every 48 hours arm 3: These are patients with acute kidney injury not yet on dialysis, receiving fondaparinux 2.5 mg subcutaneously every 48 hours
Interventions: intervention 1: Fondaparinux
Intervention descriptions: intervention 1: 2.5 mg every 48 hours

Protocol documents:
Clinical trial NCT01474109
Conditions: Systemic Sclerosis Ulcers
Keywords: systemic sclerosis digital ulcers
Sponsor: Actelion
Start date: 2011-12-01; Completion date: 2013-11-01
Enrollment: 289 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The DUAL-1 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing Period 1 will continue on their original randomized treatment into Period 2, until the last randomized patient has completed Period 1.

Patients will be randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo).

The primary objective is to demonstrate the effect of macitentan on the reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers.

Other objectives include:

* the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week 16 in SSc patients with ongoing DU disease.
* the evaluation of the safety and tolerability of macitentan in these patients.
* the evaluation of the efficacy of macitentan on time to first DU complication during the entire treatment period.

Detailed description:
Recurrent digital ulcers (DU) are a manifestation of vascular disease in patients with systemic sclerosis (SSc), are an important source of morbidity and lead to impaired function in these patients. In this study, we are investigating whether treatment with the endothelin receptor antagonist, macitentan, decreases the development of new digital ulcers in patients with SSc. Macitentan is a highly potent, tissue-targeting dual endothelin receptor antagonist. Through complete blockade of endothelin action, macitentan is expected to protect tissue from the damaging effect of elevated endothelin. This therapy is not approved for the treatment of systemic sclerosis, but the use of an ERA is an attractive approach in combating the structural vascular damage observed in SSc leading to complications such as DUs.

Arms: arm 1: macitentan 3mg tablet once daily arm 2: macitentan 10mg tablet once daily arm 3: matching placebo once daily
Interventions: intervention 1: macitentan 3mg intervention 2: macitentan 10mg intervention 3: placebo
Intervention descriptions: intervention 1: macitentan 3mg tablet once daily intervention 2: macitentan 10mg tablet once daily intervention 3: matching placebo once daily

Protocol documents:
Clinical trial NCT01477333
Conditions: Pulmonary Arterial Hypertension
Keywords: Tyvaso UT-15C SR PAH
Sponsor: United Therapeutics
Start date: 2011-10-01; Completion date: 2013-11-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this multi-center, open-label, safety and tolerability study was to assess the addition of oral treprostinil (UT-15C sustained release \[SR\] tablets) to subjects currently receiving Tyvaso (treprostinil) inhalation solution. During the 24-week evaluation period, the study evaluated the changes in the following assessments: hemodynamics, 6-minute walk test (6MWT), Borg dyspnea score, N-Terminal pro-brain natriuretic peptide (NT-proBNP), World Health Organization (WHO) Functional Class, and safety assessments.

Eligible subjects had a diagnosis of pulmonary arterial hypertension (PAH), currently were receiving Tyvaso, and may have been receiving other approved PAH specific oral therapies (endothelin receptor antagonists \[ERAs\] and/or phosphodiesterase type 5 inhibitor \[PDE5-I\], if at a stable dose for ≥30 days). At Baseline, subjects received the first dose of 0.125 mg UT-15C SR.

Detailed description:
This was a multi-center, open-label, safety and tolerability study in WHO Group 1 PAH subjects adding UT-15C SR to Tyvaso and PAH approved background therapy. This study had a 24-week evaluation period followed by a long term safety period. Six study visits occurred in the first 24 weeks of study; Screening, Baseline, Week 4, Week 8, Week 12, and Week 24 visits. Right heart catheterization occurred between 2-4 hours following the last Tyvaso dose at Baseline (prior to the administration of UT-15C SR) and Week 24.

Arms: arm 1: Initiated at 0.125 mg twice daily (BID), titrated as clinically indicated.
Interventions: intervention 1: UT-15C SR intervention 2: Tyvaso Inhalation Solution
Intervention descriptions: intervention 1: Initiated at 0.125 mg BID, titrated as clinically indicated. intervention 2: Administered as at least 9 breaths 4 times daily for at least 4 weeks prior to Baseline

Protocol documents:
Clinical trial NCT01479010
Conditions: Pulmonary Hypertension
Sponsor: Virginia Commonwealth University
Start date: 2011-11-01; Completion date: 2013-11-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label non-randomized, pilot study to evaluate the effect of Interleukin-1 blockade on exercise capacity in patients with pulmonary hypertension. Subjects will undergo cardiopulmonary exercise testing at baseline, and after 4 weeks treatment with Anakinra (recombinant human Interleukin-1 receptor antagonist.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Anakinra 100 mg subcutaneously daily
Intervention descriptions: intervention 1: Anakinra 100 mg subcutaneously daily

Protocol documents:
Clinical trial NCT01499095
Conditions: Type 2 Diabetes Mellitus
Sponsor: Sanofi
Start date: 2011-12-01; Completion date: 2013-11-01
Enrollment: 811 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

* To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus

Secondary Objective:

* To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal hypoglycemia

Detailed description:
The maximum study duration was up to approximately 58 weeks per participants, consisting of:

* up to 2 week screening period
* 6-month comparative efficacy and safety treatment period
* 6-month comparative safety extension period
* 4-week safety follow-up period in a subset of participants
* a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lantus (Insulin glargine) intervention 2: HOE901-U300 (new formulation of insulin glargine)
Intervention descriptions: intervention 1: Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL). intervention 2: HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). Dose titration seeking fasting plasma glucose 4.4 - 5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]). After 6 months participants were proposed to participate to the administration substudy and to receive either HOE901-U300 once daily at intervals of 24 +/- 3 hours (adaptable dosing intervals) or to continue once daily injections of HOE901-U300 every 24 hours (fixed dosing intervals) up to Month 9.

Protocol documents: