ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01213966
Conditions: Malaria, Falciparum Malaria, Vivax
Keywords: Acute uncomplicated Plasmodium Falciparum malaria Blood stage Plasmodium Vivax malaria
Sponsor: Medicines for Malaria Venture
Start date: 2010-10-01; Completion date: 2012-05-01
Enrollment: 82 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A Phase IIa Exploratory, Open label, Single Dose Regimen, Multiple Dose Testing Clinical Study to Assess the Preliminary Efficacy, Tolerability and Pharmacokinetics of OZ439 in adult patients with acute, uncomplicated Plasmodium falciparum or vivax malaria mono-infection.

Detailed description:
This exploratory Phase IIa study aims to investigate the preliminary efficacy in terms of parasite reduction and clearance in malaria patients, and the tolerability of OZ439 administered as single dose regimen at 3 different doses in parallel cohorts of patients with either acute uncomplicated Plasmodium falciparum or Plasmodium vivax malaria mono-infection (10 patients per plasmodium species per dose level).

Treatment with OZ439 will be given as a single dose on Day 0, starting in the first cohort at a dose of 800 mg. Established antimalarial therapy will be given at the latest at 36 hours post dosing.

The primary endpoint will be the derived parasite reduction rate (PRR) at 24 hours after study drug administration.

A review of each individual study cohort (dose/species) will be conducted with the Principal Investigator and the Sponsor and a decision will be reached on whether the dose for the next cohort should increase or decrease (within 200mg-1600mg range). This decision will be based on parasite reduction rate over the first 24 hours following administration of OZ439, tolerability and exposure.

Arms: arm 1: 800 mg OZ439 po single dose arm 2: 400 mg OZ439 p.o. single dose arm 3: 200mg OZ439 p.o. single dose arm 4: 1200 mg OZ439 po single dose
Interventions: intervention 1: OZ439
Intervention descriptions: intervention 1: po, single dose

Protocol documents:
Clinical trial NCT01214174
Conditions: Ocular Inflammation
Keywords: cataract inflammation
Sponsor: ICON Bioscience Inc
Start date: 2010-10-01; Completion date: 2012-05-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after cataract surgery.

Detailed description:

Arms: arm 1: 513ug arm 2: 776ug arm 3: 1046ug
Interventions: intervention 1: IBI-10090
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01214239
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2010-10-01; Completion date: 2012-05-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of treatment in monotherapy in patients with type 2 diabetes and insufficient glycaemic control.

Detailed description:

Arms: arm 1: once a day arm 2: once a day
Interventions: intervention 1: Placebo intervention 2: Linagliptin
Intervention descriptions: intervention 1: once a day intervention 2: once a day

Protocol documents:
Clinical trial NCT01214629
Conditions: Advanced Cancer Metastatic Cancer
Keywords: Advanced Cancer Metastatic Cancer Cancer
Sponsor: Eli Lilly and Company
Start date: 2007-07-01; Completion date: 2012-05-01
Enrollment: 54 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to determine the safety of LY2523355 for the treatment of advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).

Detailed description:
This study is a multi-center, non-randomized, open label, dose-escalation, Phase 1 study of intravenous LY2523355 in participants with advanced and/or metastatic cancer (including Non-Hodgkin's Lymphoma) for whom no treatment of higher priority exists.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: LY2523355 intervention 2: LY2523355 intervention 3: pegfilgrastim
Intervention descriptions: intervention 1: Administered intravenously as a 1-hour infusion on Days 1, 2, 3 of each 21-day cycle for at least 2 cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion is met. Starting dose for LY2523355 alone arm is 0.125 milligrams per meter square per day (mg/m²/day). intervention 2: Administered intravenously as a 1-hour infusion on Days 1, 2, 3 of each 21-day cycle for at least 2 cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion is met. Starting dose for LY2523355 + pegfilgrastim is 4 mg/m²/day. intervention 3: 6 milligrams (mg) administered subcutaneously on Day 4 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received.

Protocol documents:
Clinical trial NCT01215643
Conditions: Hepatitis C Chronic Pain
Keywords: Chronic hepatitis C genotype 2 Chronic hepatitis C genotype 3 Cyclophilin inhibitor
Sponsor: Debiopharm International SA
Start date: 2010-10-01; Completion date: 2012-05-01
Enrollment: 340 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.

Detailed description:

Arms: arm 1: Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24. arm 2: Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24. arm 3: Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24. arm 4: Alisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24. arm 5: Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.
Interventions: intervention 1: Alisporivir intervention 2: Peginterferon alfa-2a intervention 3: Ribavirin
Intervention descriptions: intervention 1: ALV 200 mg soft gel capsules administered orally intervention 2: PEG 180 μg administered via subcutaneous (s.c.) injection once weekly intervention 3: RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)

Protocol documents:
Clinical trial NCT01226043
Conditions: Diabetes Mellitus, Type 2
Sponsor: Sanofi
Start date: 2010-10-01; Completion date: 2012-05-01
Enrollment: 405 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Primary Objective:

To assess patient preference for Lantus SoloSTAR pen versus Lantus vial and syringe at the end of Crossover Phase (Week 4) in patients with type 2 diabetes mellitus (T2DM)

Secondary Objectives:

To compare Lantus SoloSTAR pen versus Lantus vial and syringe with regard to the following parameters:

Randomization/Crossover phase:

* Healthcare professional's (HCP) recommendation for Lantus SoloSTAR pen versus Lantus vial and syringe

Re-randomization phase:

* Change in Fasting Plasma Glucose (FPG) from week 4 to week 10
* Percentage of patients achieving FPG\<110 mg/dL at week 10
* Change in Lantus dose injected per day (U) from week 4 to week 10

Observational phase:

* Percentage of patients achieving glycosylated hemoglobin (HbA1c) goal (\<7%) at week 40
* Time to first observation of HbA1c\<7% during the observational phase
* Percentage of patients who discontinue Investigational Product (IP) during the observational phase due to dissatisfaction with their current device

All phases:

* Percentage of patients who discontinue IP during each phase of the study
* Safety assessment such as occurrence of hypoglycemic events (HE) and adverse events (AE)

Detailed description:
This study consisted of a 1 week Screening Phase, a 4-week Randomization/Crossover Phase, a 6-week Re-randomization Phase, followed by a 30 week Observational Phase.

The total duration of study participation was up to 41 weeks with a total treatment duration of up to 40 weeks of Lantus exposure.

Arms: arm 1: 10 mL vial, 1000 U per vial for subcutaneous administration once a day. Starting dose will be 0.2 Unit per kilogram of body weight. arm 2: 3 mL SoloSTAR pre-filled disposable insulin delivery device (pen), 300 U per device for subcutaneous administration once a day. Starting dose will be 0.2 Unit per kilogram of body weight.
Interventions: intervention 1: Insulin Glargine
Intervention descriptions: intervention 1: * Pharmaceutical form: solution for injection
* Route of administration: subcutaneous

Protocol documents:
Clinical trial NCT01232894
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: indacaterol COPD Long-acting beta2-agonist (LABA)
Sponsor: Novartis Pharmaceuticals
Start date: 2011-03-01; Completion date: 2012-05-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this 12-week study, patients were randomized to either open-label indacaterol or standard of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were assessed.

Detailed description:

Arms: arm 1: Indacaterol 150 µg once-daily via single-dose dry powder inhaler arm 2: Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
Interventions: intervention 1: Indacaterol intervention 2: Long-acting beta2-agonist
Intervention descriptions: intervention 1: Indacaterol 150 µg once-daily via single-dose dry powder inhaler intervention 2: Long-acting beta2-agonist (LABA) bronchodilator monotherapy via inhaler twice daily

Protocol documents:
Clinical trial NCT01238848
Conditions: Bronchiolitis
Keywords: Hypertonic Saline Bronchiolitis Efficacy
Sponsor: Hospital General de Niños Pedro de Elizalde
Start date: 2010-12-01; Completion date: 2012-05-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital stay, oxygen requirements and clinical outcome.

Detailed description:
Despite bronchiolitis is a very frequent disease among infants, there are still controversies regarding its treatment. Hypertonic saline has been proposed as useful treatment in these children, bur information is still controversial.

The aim is to asses that using Nebulized Hypertonic Saline with bronchodilators (albuterol) may reduce the days of hospitalization and improve clinical outcomes in patients with acute bronchiolitis, compared with using Normal Saline with albuterol.

Arms: arm 1: Nebulized hypertonic saline (sodium chloride 3%) + albuterol arm 2: Normal saline (sodium chloride 0.9%) + albuterol
Interventions: intervention 1: Hypertonic saline intervention 2: Normal saline
Intervention descriptions: intervention 1: 3 cc nebulized hypertonic saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days intervention 2: 3 cc nebulized normal saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days

Protocol documents:
Clinical trial NCT01250418
Conditions: Pain
Keywords: Bispectral Index Ketamine
Sponsor: Northwestern University
Start date: 2010-08-01; Completion date: 2012-05-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study question: Does the SNAP-Index (SI) correlates better with the OASS than the BIS Monitor during sedation with ketamine?

The study hypothesis: Since the SNAP II monitor seems to be more responsive during emergence of anesthesia, it will have a better correlation with the OASS than the BIS monitor with the use of ketamine.

Detailed description:

Arms: arm 1: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min. arm 2: No ketamine added to anesthesia regimen
Interventions: intervention 1: Ketamine group
Intervention descriptions: intervention 1: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.

Protocol documents:
Clinical trial NCT01257425
Conditions: Prostate Cancer
Sponsor: Ipsen
Start date: 2010-12-01; Completion date: 2012-05-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve \[AUC1-85day\] for serum testosterone in patients with advanced prostate cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)
Intervention descriptions: intervention 1: Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85.

Triptorelin Pamoate (Pamorelin® LA 11.25 mg) applied subcutaneously (s.c.) at Day 1 and Day 85.

Protocol documents:
Clinical trial NCT01265784
Conditions: Complicated Intra-abdominal Infection
Sponsor: Tetraphase Pharmaceuticals, Inc
Start date: 2011-01-01; Completion date: 2012-05-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared with ertapenem in the treatment of adult community-acquired complicated intra-abdominal infections (cIAIs).

Detailed description:

Arms: arm 1: TP-434 was administered intravenously (IV) at a dose of 1.5 milligrams per kilogram of body weight (mg/kg) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). TP-434 treatment was to be stopped when symptoms of complicated intra-abdominal infection (cIAI) resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. arm 2: TP-434 was administered IV at a dose of 1.0 mg/kg every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). TP-434 treatment was to be stopped when symptoms of cIAI resolved, there was treatment failure, or the maximum allowed number of infusion days was reached. arm 3: Ertapenem was administered IV at a dose of 1 gram (g) q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India). Ertapenem treatment was to be stopped when symptoms of cIAI resolved, there was treatment failure, or the maximum allowed number of infusion days was reached.
Interventions: intervention 1: TP-434 intervention 2: Ertapenem intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Administered IV to maintain the blind.

Protocol documents:
Clinical trial NCT01284114
Conditions: Hypertension Chronic Kidney Disease
Keywords: Elderly chronic kidney disease Hypertension Aliskiren
Sponsor: Jichi Medical University
Start date: 2011-02-01; Completion date: 2012-05-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether aliskiren is effective in the treatment of blood pressure, hear function, renal function in elderly hypertensive chronic kidney disease (CKD) patients.

Detailed description:
Chronic kidney disease (CKD) was reported to be affecting 11% of the all population. This number is much higher in the elderly population and may be as high as 30%. CKD is an independent risk factor of cardiovascular disease (CVD). This is called "Cardio-renal Continuum". The renin-angiotensin-aldosterone system (RAS) plays pivotal roles in both cardiovascular and renal functions.

The increased oxidative stress by activated RAS on vascular endothelium is one of important factor to development of Cardio-renal Continuum. The blockade of RAS by angiotensin I converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs) has been reported to ameliorate the renal disease and CVD; however,they do not completely suppress RAS, leading to a reactive rise in plasma renin activity (PRA). Aliskiren, an oral direct renin inhibitor, is effective against essential hypertension by reducing PRA, resulting in more complete suppression of RAS; however, little is known about the effects of aliskiren on heart and kidney functions in elderly hypertensive CKD patients. In this study, we assessed the efficacy of aliskiren on heart and kidney functions in elderly hypertensive CKD patients.

Arms: arm 1: None
Interventions: intervention 1: Aliskiren
Intervention descriptions: intervention 1: 150mg/day for all as initial dose, 300mg/day for the patients that still show hypertension(above 140/90mmHg)after one month 150mg treatment,oral,on 6 months

Protocol documents:
Clinical trial NCT01302054
Conditions: Urinary Bladder, Overactive
Keywords: Bladder Overactive Overactive urinary bladder Overactive Bladder
Sponsor: Pfizer
Start date: 2011-05-01; Completion date: 2012-05-01
Enrollment: 990 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. Sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. Fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. So, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. This study will help find out if this is what happens.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fesoterodine 8 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Fesoterodine sustained release tablets once every morning at 4 mg dose for first week, followed by 11 weeks at 8 mg strength. intervention 2: Matching placebo for fesoterodine 4 and 8 mg for a total of 12 weeks.

Protocol documents:
Clinical trial NCT01308060
Conditions: Canthal Lines
Keywords: Canthal lines
Sponsor: Galderma R&D
Start date: 2011-01-01; Completion date: 2012-05-01
Enrollment: 335 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This double-blind study has two parts for each subject (same population):

Part A: initial treatment in Lateral Canthal Lines (LCL) (placebo-controlled):

* To assess the efficacy and safety of Azzalure® compared to placebo in the improvement of moderate to severe LCLs.
* To assess the subjects' level of satisfaction with the appearance of their LCLs compared to placebo.

Part B: repeated treatment in LCL with or without Glabellar Lines (GL) (active treatment, up to 1 year):

* To assess safety of Azzalure® following repeated administration in the improvement of moderate to severe LCLs.
* To assess the safety of Azzalure® when used concomitantly for improvement of moderate to severe LCLs and GLs.
* To assess the subjects' level of satisfaction with the appearance of their LCLs.

Detailed description:

Arms: arm 1: During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo arm 2: During part A, efficacy and safety parameters will be assessed for Azzalure vs. placebo
Interventions: intervention 1: Botulinum Toxin Type A intervention 2: Placebo
Intervention descriptions: intervention 1: During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo. intervention 2: None

Protocol documents:
Clinical trial NCT01313494
Conditions: COPD
Keywords: COPD Roflumilast FEV1 China
Sponsor: AstraZeneca
Start date: 2011-03-01; Completion date: 2012-05-01
Enrollment: 626 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this trial is to determine the efficacy, safety and tolerability of 500 µg Roflumilast tablets once daily in patients with COPD in China, Hong Kong, and Singapore.

Detailed description:

Arms: arm 1: Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks. arm 2: Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
Interventions: intervention 1: Roflumilast intervention 2: Placebo intervention 3: Salbutamol
Intervention descriptions: intervention 1: Roflumilast tablets intervention 2: Placebo tablets intervention 3: Salbutamol (given by MDI and spacer) used as rescue medication on an ass needed basis throughout the trial, and was used for post-bronchodilator spirometry tests at all study visits.

Protocol documents:
Clinical trial NCT01327703
Conditions: Exocrine Pancreatic Insufficiency Cystic Fibrosis
Keywords: Exocrine Pancreatic Insufficiency Cystic Fibrosis Steatorrhea Malabsorption Malnutrition
Sponsor: Forest Laboratories
Start date: 2011-04-01; Completion date: 2012-05-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000 compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).

Detailed description:
This is an open-label, Phase IV, multicenter, randomized, two-period cross-over study to compare the efficacy and safety of Panzytrat® 25,000 to Kreon® 25,000 in participants aged 7 years and older suffering from CF and EPI. The study consists of a qualification phase (5 to 15 days); two treatment periods of 14 days each (plus a 3-day window if needed) and a 3-day stool collection will be performed from Days 12 to 15.

A safety follow-up phone call will be arranged 7-10 days after completion of the treatment phase or after an early discontinuation.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Panzytrat® 25,000 intervention 2: Kreon® 25,000
Intervention descriptions: intervention 1: Panzytrat® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day in either first treatment period or second treatment period. intervention 2: Kreon® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 Ph.Eur. units lipase/kg body weight/day in either first treatment period or second treatment period.

Protocol documents: