ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01503021
Conditions: End Stage Renal Disease Chronic Kidney Disease
Keywords: Soluble ferric pyrophosphate Chronic kidney disease Chronic hemodialysis Ferric pyrophosphate citrate
Sponsor: Rockwell Medical Technologies, Inc.
Start date: 2011-11-01; Completion date: 2014-01-01
Enrollment: 718 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the parent study is to assess the short-term safety and tolerability of soluble ferric pyrophosphate (SFP) in dialysate administered to a large number of representative adult chronic kidney disease patients on hemodialysis (CKD-HD).

The purpose of the extension study is to assess the long-term safety and tolerability of SFP.

Detailed description:
Parent Study: randomized, double-blinded, crossover, up to 6 weeks, 700 patients. Patients were randomized to receive SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate or placebo (standard liquid bicarbonate concentrate) x 2 weeks, then a 1 week washout, then crossed over to the alternate treatment x 2 weeks.

Extension Study: open-label, single active arm, uncontrolled study, up to 53 weeks, 300 patients. Following completion of the RMTI-SFP-6 parent study, patients could enter the extension study, where they received SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate for up to 52 weeks.

Arms: arm 1: Soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks arm 2: Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
Interventions: intervention 1: SFP intervention 2: Placebo
Intervention descriptions: intervention 1: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate intervention 2: Dialysis with standard liquid bicarbonate concentrate without iron

Protocol documents:
Clinical trial NCT01519089
Conditions: Psoriasis
Keywords: chronic severe moderate treatment safety efficacy CP-690 550 Plaque psoriasis Psoriasis Vulgaris Psoriatic Arthritis tofacitinib Xeljanz
Sponsor: Pfizer
Start date: 2012-03-01; Completion date: 2014-01-01
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this study is to evaluate the long term safety of CP-690,550 in patients being treated for moderate to severe plaque psoriasis and/or psoriatic arthritis. This study will also to compare the efficacy of two oral doses of CP-690,550 (5 mg BID and 10 mg BID) after 16 weeks of treatment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CP-690,550 intervention 2: CP-690, 550
Intervention descriptions: intervention 1: 10 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks. intervention 2: 5 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.

Protocol documents:
Clinical trial NCT01519167
Conditions: Ultrasound CT Scans MRIs
Sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Start date: 2012-10-01; Completion date: 2014-01-01
Enrollment: 91 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the safety of dexmedetomidine in a pediatric population requiring non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS) for elective diagnostic or therapeutic procedures, expected to take more than 30 minutes.

Detailed description:
This study was designed to evaluate the safety of a continuous infusion of dexmedetomidine (1 mcg/kg loading dose with 0.6 mcg/kg/hr initial maintenance dose and titrated between 0.2-1.0 mcg/kg/hr) administered to subjects requiring non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS) for elective diagnostic or therapeutic procedures that are expected to take more than 30 minutes.

Arms: arm 1: None
Interventions: intervention 1: Dexmedetomidine intervention 2: Midazolam intervention 3: Fentanyl
Intervention descriptions: intervention 1: 0.1 - 1.0 mcg/kg/hr IV intervention 2: 0.025 - 2 mg/kg IV intervention 3: 0.5 - 3 mcg/kg IV

Protocol documents:
Clinical trial NCT01519661
Conditions: Pulmonary Infections Pseudomonas Aeruginosa in Cystic Fibrosis
Keywords: Tobramycin Inhalation powder Cystic fibrosis Lung disease Anti-bacterial agents
Sponsor: Novartis Pharmaceuticals
Start date: 2012-01-01; Completion date: 2014-01-01
Enrollment: 157 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.

Detailed description:

Arms: arm 1: Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
Interventions: intervention 1: TBM100
Intervention descriptions: intervention 1: Tobramycin inhalation powder was assigned as four capsules at 28mg dosage strength. It was inhaled b.i.d in the morning and in the evening via the T-326 Inhaler.

Protocol documents:
Clinical trial NCT01520909
Conditions: Idiopathic Thrombocytopenic Purpura
Keywords: immune thrombocytopenic purpura pediatrics chronic ITP idiopathic thrombocytopenic purpura eltrombopag Chronic Immune Thrombocytopenia platelet disorder thrombocytopenia
Sponsor: GlaxoSmithKline
Start date: 2012-03-01; Completion date: 2014-01-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy, safety and tolerability of eltrombopag in children with previously treated chronic immune thrombocytopenia who are between 1 and 17 years of age. This is a 2 part study. In part 1, patients will be randomized to receive either eltrombopag or placebo for 13 weeks. All patients who complete part 1 will enter part 2. In part 2, all patients will receive 24 weeks of eltrombopag.

Detailed description:
This is a two part, double-blind, randomized, placebo-controlled and open-label Phase III study to investigate the efficacy, safety and tolerability of eltrombopag in pediatric patients with previously treated chronic ITP. In Part 1, patients will be randomized to receive eltrombopag or placebo in a 13-week double-blind, placebo-controlled treatment period. After completing Part 1, patients will begin Part 2, in which they will receive eltrombopag in an open-label manner during a 24-week treatment period.

Arms: arm 1: Part 1, double-blind treatment group arm 2: Part 1, double-blind treatment group arm 3: Part 2, open-label
Interventions: intervention 1: Eltrombopag intervention 2: Placebo
Intervention descriptions: intervention 1: Thrombopoietin receptor agonist intervention 2: Placebo with no active pharmaceutical ingredient

Protocol documents:
Clinical trial NCT01522963
Conditions: Tobacco Use Disorder
Sponsor: University of Minnesota
Start date: 2011-12-01; Completion date: 2014-01-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the timeframe (relative to a stress task) that is most effective at attenuating the increase in symptoms of tobacco craving and withdrawal that occur when smokers are presented with stressful situations.

Detailed description:

Arms: arm 1: Subjects will receive the nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session arm 2: Subjects will receive the nicotine lozenge after the stress task during one laboratory session and immediately prior to the stress task at the other laboratory session arm 3: Subjects will receive the nicotine lozenge after the stress task during one laboratory session and 10 minutes prior to the stress task at the other laboratory session arm 4: Subjects will receive the nicotine lozenge 10 minutes prior to the stress task during one laboratory session and after the stress task at the other laboratory session
Interventions: intervention 1: Nicotine lozenge
Intervention descriptions: intervention 1: A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task

Protocol documents:
Clinical trial NCT01531387
Conditions: Sickle Cell Anemia
Keywords: Phase III Sickle cell anemia Conditional transcranial doppler velocities Reduce risk of conversion to abnormally high transcranial doppler velocities Pediatric patients
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2012-05-01; Completion date: 2014-01-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy (hydroxyurea) to standard care (observation) in children with sickle cell anemia and conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative regimen (hydroxyurea) to be declared superior to the standard treatment regimen (observation), the hydroxyurea-treated group must have a three-fold reduction in the incidence of conversion to abnormal TCD velocities (≥ 200 cm/sec), compared to the standard treatment arm.

Detailed description:
Results from previous studies confirm an increased risk of stroke among children with conditional TCD velocities. In addition, studies suggest that patients who were on observation alone, converted from conditional TCD (moderate risk category) to an abnormal TCD (with a much higher risk for primary stroke) within 30 months of initial identification of the conditional TCD velocity; this conversion led to initiation of chronic and indefinite transfusions in all cases. Preliminary data suggests that the risk of conversion to abnormal TCD velocities will be lower for subjects with conditional TCD velocities on hydroxyurea by at least three-fold. This important difference in conversion risk rate suggests that an alternative treatment could have a substantial and beneficial impact on patients with elevated TCD velocities.

An alternative treatment could protect the brain of patients with SCA and conditional TCD velocities who are at increased risk for stroke. The avoidance of chronic blood transfusions would be a great benefit for all children with sickle cell disease, especially those in developing countries where the blood supply may be less safe (in comparison with that in the US) or unavailable, and very costly.

Arms: arm 1: Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations arm 2: Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.
Interventions: intervention 1: Hydroxyurea
Intervention descriptions: intervention 1: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs.

Protocol documents:
Clinical trial NCT01555463
Conditions: Papulopustular Rosacea
Keywords: Rosacea
Sponsor: LEO Pharma
Start date: 2012-09-01; Completion date: 2014-01-01
Enrollment: 961 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.

Detailed description:
To determine the efficacy of AzA foam, 15% compared to vehicle topically applied twice daily in papulopustular rosacea evaluated by therapeutic success rate according to Investigators Global Assessment (IGA) and change in inflammatory lesion count from baseline to end of treatment.

Evaluation of all adverse events will be covered in Adverse Events section.

Arms: arm 1: 0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks. arm 2: 0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
Interventions: intervention 1: Azelaic acid foam, 15% (BAY39-6251) intervention 2: Vehicle foam
Intervention descriptions: intervention 1: Azelaic acid twice daily topical application intervention 2: twice daily topical application

Protocol documents:
Clinical trial NCT01558739
Conditions: Primary Myelofibrosis (PMF) Post Polycythaemia Myelofibrosis (PPV MF) Post Essential Thrombocythaemia Myelofibrosis (PET-MF)
Keywords: Ruxolitinib INC424 myelofibrosis PMF post polycythemia myelofibrosis PPV MF post-essential thrombocythemia myelofibrosis PET-MF Primary Myelofibrosis Polycythemia Thrombocythemia Essential Thrombocytosis myeloproliferative Disorders Bone Marrow Diseases Haematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Haemorrhagic Disorders
Sponsor: Novartis Pharmaceuticals
Start date: 2012-05-01; Completion date: 2014-01-01
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the efficacy of INC424 in patients with PMF, PPV MF, or PET-MF using a composite measure of either an objective endpoint (\> 50% reduction in splenomegaly using palpitation at 48 weeks) and/or a subjective endpoint (\>50% reduction in total symptom score at 48 weeks).

Detailed description:

Arms: arm 1: Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
Interventions: intervention 1: INC424
Intervention descriptions: intervention 1: Ruxolitinib was provided in 5 mg tablets, packaged in bottles. 15 - 20 mg (dose based on Baseline platelet count) twice daily.

Protocol documents:
Clinical trial NCT01570751
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2012-04-01; Completion date: 2014-01-01
Enrollment: 145 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This trial is conducted in the United States of America (USA). The aim of the trial is to confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec intervention 2: insulin glargine
Intervention descriptions: intervention 1: Cross-over trial, part 1: Individually adjusted IDeg administered subcutaneously (s.c., under the skin) once daily for 16 weeks in each treatment period. intervention 2: Cross-over trial, part 2: Individually adjusted IGlar administered subcutaneously (s.c., under the skin) once daily for the 16 week run-in period followed by 16 weeks in each treatment period.

Protocol documents:
Clinical trial NCT01585324
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2012-01-01; Completion date: 2014-01-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, multicenter, phase IV study will evaluate the relationship between the drop in hemoglobin levels and sustained virological response in patients with chronic hepatitis C genotype 1 treated with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a). Patients will receive Copegus 1000 mg or 1200 mg orally daily and Pegasys 180 mcg subcutaneously weekly. Anticipated time on study treatment, depending on virological response, will be 48 or 72 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: ribavirin [Copegus]
Intervention descriptions: intervention 1: 180 mcg subcutaneously weekly intervention 2: 1000 mg or 1200 mg orally daily

Protocol documents:
Clinical trial NCT01588353
Conditions: Dupuytren's Contracture
Keywords: AK160, collagenase clostridium histolyticum
Sponsor: Asahi Kasei Pharma Corporation
Start date: 2012-05-01; Completion date: 2014-01-01
Enrollment: 104 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the efficacy and safety of AK160 in patients with Dupuytren's Contracture.

To determine plasma concentration after the first injection of AK160 in patients with Dupuytren's Contracture.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Collagenase Clostridium Histolyticum
Intervention descriptions: intervention 1: AK160 (Collagenase Clostridium Histolyticum) 0.58 mg

Protocol documents:
Clinical trial NCT01596088
Conditions: Extravasations of Anthracycline Anti-cancer Agents
Keywords: Extravasation Anthracyclines
Sponsor: Kissei Pharmaceutical Co., Ltd.
Start date: ; Completion date: 2014-01-01
Enrollment: 2 participants; Allocation: ; Intervention model: 

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of KDX-0811(Dexrazoxane) in the treatment of accidental extravasation of anthracycline anti-cancer agents.

Detailed description:

Arms: arm 1: Dexrazoxane should be given once daily for 3 consecutive days. The dose is:

Day 1: 1000 mg/m2, Day 2: 1000 mg/m2, Day 3: 500 mg/m2 (body surface area)
Interventions: intervention 1: Dexrazoxane
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01606007
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Start date: 2012-07-01; Completion date: 2014-01-01
Enrollment: 1282 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Saxagliptin intervention 2: Metformin XR intervention 3: Dapagliflozin intervention 4: Placebo matching with Dapagliflozin intervention 5: Placebo matching with Saxagliptin
Intervention descriptions: intervention 1: Tablets, Oral, 5mg , Once daily, 24 weeks intervention 2: Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks intervention 3: Tablets, Oral, 10mg , Once daily, 24 weeks intervention 4: Tablets, Oral, 0mg, Once daily, 24 weeks intervention 5: Tablets, Oral, 0mg, Once daily, 24 weeks

Protocol documents:
Clinical trial NCT01614093
Conditions: Schizophrenia
Keywords: Schizophrenia Appetite Oxytocin
Sponsor: University of Maryland, Baltimore
Start date: 2012-06-01; Completion date: 2014-01-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to test a single dose of intranasal oxytocin, compared to placebo, in a within subjects, crossover design, to see if oxytocin will improve satiety signaling (behaviorally and/or by self report) compared to placebo. If this single dose pilot paradigm shows an increase in satiety, it may be tested in follow-up studies as a prevention or treatment for weight gain and overeating in people with schizophrenia.

Detailed description:

Arms: arm 1: Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects. arm 2: Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
Interventions: intervention 1: Oxytocin intervention 2: Placebo
Intervention descriptions: intervention 1: Single dose intranasal oxytocin (24 IU) intervention 2: Placebo- Sugar pill

Protocol documents:
Clinical trial NCT01642602
Conditions: Gastroesophageal Reflux Disease
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2012-07-01; Completion date: 2014-01-01
Enrollment: 104 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the safety and effectiveness of once daily oral administration of dexlansoprazole delayed-release capsules in adolescent participants with symptomatic non-erosive gastroesophageal reflux disease (GERD).

Detailed description:

Arms: arm 1: Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
Interventions: intervention 1: Dexlansoprazole
Intervention descriptions: intervention 1: Dexlansoprazole delayed-release capsules.

Protocol documents:
Clinical trial NCT01673386
Conditions: Metastatic Renal Cell Carcinoma
Keywords: Tivozanib hydrochloride renal cell carcinoma subject preference quality of life
Sponsor: AVEO Pharmaceuticals, Inc.
Start date: 2012-07-01; Completion date: 2014-01-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for Renal Cell Carcinoma (RCC).

Detailed description:
This is a randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for Renal Cell Carcinoma (RCC). Approximately 160 subjects will be stratified for ECOG score (0 vs 1) and histology (clear cell vs non-clear cell) and then will be randomized 1:1 to 1 of 2 treatment arms. The study consists of two 12-week treatment periods with a 1-week washout in between. Subjects will receive double-blind (over-encapsulated) tivozanib hydrochloride and sunitinib sequentially. The study is designed to compare subject treatment preference, as well as overall safety and tolerability, frequency of dose modifications and kidney-specific health outcomes/QoL.

Arms: arm 1: 1.5 mg oral tivozanib hydrochloride daily on a 3 weeks on/1 week off schedule for 12 weeks, followed by 50 mg oral sunitinib daily on a 4 weeks on/2 weeks off schedule for 12 weeks. arm 2: 50 mg oral sunitinib daily on a 4 weeks on/2 weeks off schedule for 12 weeks, followed by 1.5 mg oral tivozanib hydrochloride daily on a 3 weeks on/1 week off schedule for 12 weeks.
Interventions: intervention 1: Tivozanib intervention 2: Sunitinib
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: