ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00941031
Conditions: Chronic Plaque-type Psoriasis
Keywords: Moderate to severe chronic plaque-type psoriasis AIN457 dermatology
Sponsor: Novartis Pharmaceuticals
Start date: 2009-07-01; Completion date: 2010-12-01
Enrollment: 404 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).

Detailed description:

Arms: arm 1: Induction with single injection - "Single": secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12 arm 2: Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12 arm 3: Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12 arm 4: Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
Interventions: intervention 1: AIN457 intervention 2: AIN457A intervention 3: AIN457A intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9 intervention 3: Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5 intervention 4: Placebo - "Placebo": Placebo administered at weeks 1, 2, 3, 5, 9

Protocol documents:
Clinical trial NCT00956839
Conditions: Pancreatitis, Chronic
Keywords: Tropical calcific pancreatitis Tropical chronic pancreatitis Chronic pancreatitis Vitamin D Vitamin D deficiency Cholecalciferol Intramuscular vitamin D3
Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences
Start date: 2009-07-01; Completion date: 2010-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of 2 different doses of intramuscular (IM) vitamin D3 as compared to an oral replacement dose in normalizing vitamin D levels in the blood of patients with tropical calcific pancreatitis.

Detailed description:
Tropical calcific pancreatitis (TCP) is a form of chronic pancreatitis unique to developing countries. Patients with TCP often have malabsorption leading to nutritional deficiencies. We have noted that vitamin D deficiency is common in patients with TCP. The ideal regimen for supplementing vitamin D3 in chronic pancreatitis remains unclear and there are no previous studies available. High dose oral vitamin D2 has been shown to be ineffective in normalizing vitamin D levels in patients with pancreatic insufficiency due to cystic fibrosis.

Intramuscular (IM) vitamin D3 supplementation in chronic pancreatitis has certain advantages. Firstly, decreased and inconsistent absorption from the intestine is avoided. Secondly, IM vitamin D3 has a long duration of action (6-12 months). The safety of high-dose IM vitamin D3 has been proven in previous studies in healthy individuals. Finally, the injection form is considerably less expensive as compared to oral vitamin D3.

The aim of the current prospective double blind study is to compare 2 regimens of high dose IM vitamin D3 replenishment with oral vitamin D3 in standard recommended doses in normalizing serum vitamin D3 levels in patients with TCP.

Arms: arm 1: IM Vitamin D3 3,00,000 Units single dose arm 2: IM vitamin D3 6,00,000 Units single dose arm 3: Oral vitamin D3 500 Units/ day
Interventions: intervention 1: Vitamin D3 (Cholecalciferol)
Intervention descriptions: intervention 1: Arm 1 - Intramuscular vitamin D3 3,00,000 Units single dose

Arm 2 - Intramuscular vitamin D3 6,00,000 Units single dose

Arm 3 - Oral vitamin D3 500 Units/day for 6 months

Protocol documents:
Clinical trial NCT00960934
Conditions: Osteoporosis
Keywords: Osteoporosis Postmenopausal MK-5442
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-10-01; Completion date: 2010-12-01
Enrollment: 383 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to identify an appropriate dose of

MK-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal women with osteoporosis.

Detailed description:
Amendment 4 of the protocol changed the duration of the study from 2 years to 6 months.

Arms: arm 1: Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months. arm 2: Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months. arm 3: Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months. arm 4: Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months. arm 5: Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months. arm 6: Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Interventions: intervention 1: MK-5442 intervention 2: Placebo intervention 3: Vitamin D3 intervention 4: Calcium carbonate
Intervention descriptions: intervention 1: MK-5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for at least 6 months. intervention 2: Dose-matched oral placebo to MK-5442 intervention 3: Vitamin D3, two 400 IU tablets daily throughout the study. intervention 4: Participants who had a calcium intake of less than 1200 mg/day at baseline received a daily 500 mg calcium supplement throughout the study.

Protocol documents:
Clinical trial NCT00974220
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: inhaled fentanyl dyspnea exercise COPD
Sponsor: Queen's University
Start date: 2010-01-01; Completion date: 2010-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Breathing discomfort (dyspnea) and activity limitation are dominant symptoms of chronic obstructive pulmonary disease (COPD) and contribute to poor health-related quality of life in this population. Several small, uncontrolled studies and published case reports have provided evidence that inhaled fentanyl, a powerful pain relieving (opioid) medication, may be used to effectively reduce breathing discomfort in patients with advanced disease. However, the mechanisms of this improvement remain unclear. Therefore, the investigators plan to conduct the first randomized, double-blind, placebo-controlled, crossover study designed to explore the possible mechanisms of action of inhaled fentanyl on activity-related dyspnea and exercise performance in patients with advanced COPD.

Detailed description:

Arms: arm 1: nebulized 0.9% saline placebo arm 2: nebulized fentanyl citrate (50 mcg)
Interventions: intervention 1: fentanyl intervention 2: normal saline (placebo)
Intervention descriptions: intervention 1: single dose, 50 mcg of nebulized fentanyl citrate intervention 2: single dose, 0.9% saline solution

Protocol documents:
Clinical trial NCT00980681
Conditions: Renal Disease
Keywords: Renal disease Contrast agent MRA
Sponsor: Guerbet
Start date: 2009-09-01; Completion date: 2010-12-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.

Detailed description:
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.

Arms: arm 1: Each subject will receive one injection of Dotarem 0.2ml/kg. arm 2: Each subject will undergo a TOF Magnetic Resonance Angiography
Interventions: intervention 1: Dotarem intervention 2: Time of Flight
Intervention descriptions: intervention 1: Each subject will receive one injection of Dotarem 0.2ml/kg intervention 2: Each subject will undergo a TOF MRA

Protocol documents:
Clinical trial NCT00982644
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2009-09-01; Completion date: 2010-12-01
Enrollment: 1030 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin glargine in subjects with type 2 diabetes.

All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor treatment is also discontinued). Subjects who consent to participate in the extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to which they were randomly allocated in the 52 week main trial.

The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension period is registered as NN1250-3643.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec intervention 2: insulin glargine
Intervention descriptions: intervention 1: Injected subcutaneously (under the skin) once daily. Dose was individually adjusted. intervention 2: Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

Protocol documents:
Clinical trial NCT00985504
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Apathy Duloxetine Hydrochloride SSRI Escitalopram
Sponsor: Eli Lilly and Company
Start date: 2009-09-01; Completion date: 2010-12-01
Enrollment: 483 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to provide a comparison of the apathy, depression, and functional outcomes associated with switching to duloxetine or escitalopram in patients who have previously responded to treatment with a selective serotonin reuptake inhibitor (SSRI) for major depressive disorder and who have residual apathy in the absence of depressed mood.

Detailed description:
Apathy is reported by up to 30% of patients with major depressive disorder (MDD) and is hypothesized to be a treatment emergent adverse effect associated with selective serotonin reuptake inhibitor medication. While there is currently no consistent method for treating apathy among psychiatrists, it has been proposed that switching MDD patients to antidepressant medications containing both serotonin and norepinephrine, such as duloxetine, may reduce the incidence and severity of apathy in these patients.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Duloxetine intervention 2: Escitalopram
Intervention descriptions: intervention 1: 60-120 milligrams (mg) taken once daily (QD) by mouth (po) for 8 weeks; with option for additional 2 weeks. intervention 2: 10-20 mg taken QD po for 8 weeks; with option for additional 2 weeks.

Protocol documents:
Clinical trial NCT00986245
Conditions: Parkinson Disease
Keywords: Parkinson disease Ropinirole
Sponsor: Seoul National University Hospital
Start date: 2009-09-01; Completion date: 2010-12-01
Enrollment: 82 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
1. In order to compare the benefit, side effects, and patient preference of Ropinirole prolonged release when used in once-daily or twice-daily dosing
2. In order to estimate the conversion rate of dopamine agonists into Ropinirole prolonged release

Detailed description:
1. Study subjects : Parkinson disease who are on Ropinirole immediate release or Pramipexole immediate release and are considering to change into Ropinirole prolonged release
2. Cross over study design:

   * Group 1: once daily dose for 2 month then into twice daily in divided dose for 2 months
   * Group 2: twice daily in divided dose for 2 months then into once daily dose for 2 months
3. Dose adjustment may be done in the first 4 weeks.
4. Compare the benefit,side effects, and patient preference between the once daily vs twice daily dosing.

Arms: arm 1: Give Roipinirole prolonged release (PR) once-daily (QD) dose first, then twice-daily (BID) dosing arm 2: Give Ropinirole prolonged release (PR) twice-daily (BID) dosing, and then once-daily (QD) dosing
Interventions: intervention 1: Ropinirole Prolonged release
Intervention descriptions: intervention 1: Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily

Protocol documents:
Clinical trial NCT00992407
Conditions: Schizophrenia
Keywords: Schizophrenia Risperidone Risperdal
Sponsor: Janssen Korea, Ltd., Korea
Start date: 2007-12-01; Completion date: 2010-12-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of long acting injectable (LAI) risperidone and oral risperidone treatment on participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) or schizoaffective disorder (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder).

Detailed description:
This is a randomized (treatment group assigned by chance), open-label (all involved people know the identity of the study drug), active-controlled study to evaluate the improvement in social functioning among participants with schizophrenia taking LAI risperidone and oral risperidone tablet. The study drug will be administered for 52 weeks in flexible dose (range as per Investigator's discretion) and a total of 11 assessment visits will be conducted per participant, including Screening. The participant may be withdrawn from the trial for any medical reason at the sole discretion of the investigator. Before starting the study treatment, participants undergo the period of switching from the previous medication to risperidone for 4 weeks, and then they will be evaluated for tolerability for 2 weeks (run-in period for stabilizing to risperidone). In this 2-week period, participants will take oral risperidone. The efficacy will be primarily evaluated through Personal and Social Performance Scale. Safety will be evaluated through Abnormal Involuntary Movement Scale, Barnes Akathisia Rating Scale, and Simpson-Angus Rating Scale. Participants' safety will be monitored throughout the study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Risperidone long acting injectables intervention 2: Risperidone tablets
Intervention descriptions: intervention 1: Risperidone long acting injectables will be administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52. A supplementary oral antipsychotic will also be administered for 3-4 weeks after the initial dose of injection. intervention 2: Risperidone tablets will be administered orally as 0.5-10 mg daily up to Week 52.

Protocol documents:
Clinical trial NCT01001104
Conditions: Diabetes Mellitus, Type 2
Keywords: Metabolic Diseases Glucose Metabolism Disorders Diabetes GLP-1 Lilly
Sponsor: Eli Lilly and Company
Start date: 2009-10-01; Completion date: 2010-12-01
Enrollment: 145 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to assess dose-response characteristics in Japanese patients with Type 2 Diabetes taking LY2189265 monotherapy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: LY2189265 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks. intervention 2: Administered by SC injection, QW for 12 weeks.

Protocol documents:
Clinical trial NCT01005901
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD NVA FEV1
Sponsor: Novartis
Start date: 2009-10-01; Completion date: 2010-12-01
Enrollment: 1324 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms: arm 1: Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication. arm 2: Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
Interventions: intervention 1: Glycopyrronium bromide intervention 2: Placebo
Intervention descriptions: intervention 1: Glycopyrronium bromide 50µg was supplied as inhalation capsules for use via a Single Dose Dry Powder Inhaler (SDDPI) intervention 2: Placebo inhalation capsules were provided for use via a SDDPI

Protocol documents:
Clinical trial NCT01006590
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus Saxagliptin Randomised Double-blind
Sponsor: AstraZeneca
Start date: 2009-10-01; Completion date: 2010-12-01
Enrollment: 286 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin.

Detailed description:

Arms: arm 1: Saxagliptin 5 mg arm 2: Metformin 500 -1000 mg
Interventions: intervention 1: Saxagliptin intervention 2: Metformin
Intervention descriptions: intervention 1: 5 mg, oral tablet, once daily intervention 2: 500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy

Protocol documents:
Clinical trial NCT01007591
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2009-10-01; Completion date: 2010-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An international, multi-centre, prospective, randomised, double-blind, active-controlled, 2-arm, parallel group, 8-week, phase 3 clinical study in paediatric patients (aged 6 to 17 years) with psoriasis vulgaris on the face and on the intertriginous areas

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: LEO 80190 intervention 2: Hydrocortisone
Intervention descriptions: intervention 1: Applied once daily intervention 2: Applied once daily

Protocol documents:
Clinical trial NCT01010932
Conditions: Cerebral Arterial Diseases
Keywords: carotid or vertebral artery disease Contrast agent MRA
Sponsor: Guerbet
Start date: 2009-10-01; Completion date: 2010-12-01
Enrollment: 222 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.

Detailed description:
Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.

Arms: arm 1: Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.
Interventions: intervention 1: Dotarem intervention 2: TOF MRA
Intervention descriptions: intervention 1: Each subject will receive one injection of Dotarem 0.2ml/kg intervention 2: Each subject will undergo a Time of Flight Magnetic Resonance Angiography (TOF MRA)

Protocol documents:
Clinical trial NCT01012674
Conditions: Cerebral Arterial Diseases
Keywords: carotid or vertebral artery disease Contrast agent MRA
Sponsor: Guerbet
Start date: 2009-10-01; Completion date: 2010-12-01
Enrollment: 211 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.

Detailed description:
Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA

Arms: arm 1: Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.
Interventions: intervention 1: Dotarem intervention 2: TOF MRA
Intervention descriptions: intervention 1: Each subject will receive one injection of Dotarem 0.2ml/kg intervention 2: Each subject will undergo a Time Of Flight Magnetic Resonance Angiography (TOF MRA)

Protocol documents:
Clinical trial NCT01022502
Conditions: Psoriasis Vulgaris
Keywords: psoriasis, indigo naturalis
Sponsor: Yin-ku Lin
Start date: 2009-11-01; Completion date: 2010-12-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To compare the efficacy and safety of refined indigo naturalis ointment with that of crude ointment in treating psoriasis.

Detailed description:
Our previous studies have shown that topical application of indigo naturalis significantly improves psoriatic symptoms. However, patient compliance is hindered because the preparation is unsightly and stains clothing.

To improve patient compliance, we have developed a refined formulation in which closer to natural skin tones and less prone to stain clothing. In this study, we evaluated the efficacy and safety of this refined form of oil extract ointment and compared the results with those of the original crude form of indigo naturalis ointment in treating psoriasis.

Arms: arm 1: Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks, starting on the date of enrollment in the study arm 2: Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks, starting on the date of enrollment in the study
Interventions: intervention 1: refined indigo naturalis ointment intervention 2: crude indigo naturalis ointment
Intervention descriptions: intervention 1: The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks. intervention 2: The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks.

Protocol documents: