ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01054170
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary lung respiratory disease efficacy placebo-controlled COPD FEV1 St Georges Respiratory Questionnaire Computed Tomography MSCT
Sponsor: AstraZeneca
Start date: 2010-01-01; Completion date: 2010-11-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate structural changes effected by AD9668 in the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice Computed Tomography (MSCT)

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AZD9668 intervention 2: Placebo
Intervention descriptions: intervention 1: 2 x 30 mg oral tablets twice daily (bid) for 12 weeks intervention 2: 2 x matched placebo to oral tablet twice daily (bid) for 12 weeks

Protocol documents:
Clinical trial NCT01059864
Conditions: Rheumatoid Arthritis
Keywords: cholesterol lipids rheumatoid arthritis CP-690 550
Sponsor: Pfizer
Start date: 2010-02-01; Completion date: 2010-11-01
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
All patients will be in instructed to eat a therapeutic lifestyle diet and will receive CP-690,550 throughout the 12 weeks of this study. After 6 weeks, half will receive the cholesterol lowering agent, atorvastatin, and half a matching placebo. This study will first measure the effects of CP-690,550 on cholesterol levels and then the effects of adding atorvastatin on those levels.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CP-690,550 intervention 2: Atorvastatin intervention 3: CP-690,550 intervention 4: Atorvastatin Placebo
Intervention descriptions: intervention 1: 12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12 intervention 2: Starting at Week 6 and continuing through Week 12 atorvastatin 10 mg oral tablets administered once daily intervention 3: 12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12 intervention 4: Starting at Week 6 and continuing through Week 12 atorvastatin placebo tablets administered once daily

Protocol documents:
Clinical trial NCT01065714
Conditions: Atopic Dermatitis
Keywords: Transepidermal water loss Epidermal barrier Skin hydration
Sponsor: Derm Research, PLLC
Start date: 2010-02-01; Completion date: 2010-11-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
While the repair of the epidermal barrier in atopic dermatitis is of major importance in the treatment of atopic dermatitis, most of the vehicles used may actually cause a worsening of an impaired epidermal barrier. Hydrogel vehicle is anecdotally known to be moisturizing and hydrating.This study will compare the use of Hydrogel vehicle and Eucerin Lotion in maintaining the epidermal barrier in subjects with atopic dermatitis.

Detailed description:

Arms: arm 1: Parallel designed study. Split body treatment arm 2: Parallel study design. Split body study.
Interventions: intervention 1: Hydrogel vehicle intervention 2: Eucerin Lotion
Intervention descriptions: intervention 1: Each morning and evening, gently wash the target area with warm water and gently pat dry with soft towel. Once dry place a small amount of Hydrogel vehicle onto the tip of your finger. Place a dab of the Hydrogel vehicle on either the left or right side of the body as instructed. (Do not use Hydrogel vehicle and Eucerin lotion on the same side of the body.) intervention 2: Each morning and evening, gently wash the area with warm water and pat dry with a soft towel. Once dry, place a small amount of Eucerin lotion to the target area on either the left or right side of the body as instructed. (Do not use Eucerin and Hydrogel vehicle on the same side of the body.)

Protocol documents:
Clinical trial NCT01068665
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2010-03-01; Completion date: 2010-11-01
Enrollment: 460 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in South Africa, Europe and North America. The aim of this trial is to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4 (DPP-4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs) qualifying for intensified treatment.

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 NCT01068678
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2010-02-01; Completion date: 2010-11-01
Enrollment: 460 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia, Europe, and North America. The aim of this clinical trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes currently treated with metformin alone or with metformin combined with an oral anti-diabetic drug (OAD) qualifying for intensified treatment.

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) three times weekly. Dose was individually adjusted. intervention 2: Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.

Protocol documents:
Clinical trial NCT01071070
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease Secondary hyperparathyroidism
Sponsor: Abbott
Start date: 2009-11-01; Completion date: 2010-11-01
Enrollment: 216 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

Detailed description:
Evaluate the safety and efficacy of paricalcitol injection with two different dosing regimens (currently approved dosing regimen used in the US package insert versus dosing based on a formula of iPTH/80 that was approved and used in the EU package insert) in Chronic Kidney Disease (CKD) Stage 5 subjects with secondary hyperparathyroidism receiving hemodialysis.

Arms: arm 1: Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL). arm 2: Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
Interventions: intervention 1: paricalcitol
Intervention descriptions: intervention 1: Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details.

Protocol documents:
Clinical trial NCT01074125
Conditions: Hyperphosphatemia End-Stage Renal Disease
Keywords: Hyperphosphatemia ESRD Dialysis End Stage Renal Disease Phosphorus Renal Kidney
Sponsor: Keryx Biopharmaceuticals
Start date: 2010-05-01; Completion date: 2010-11-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.

Detailed description:
There will be a screening visit about 4 weeks receiving study drug. Upon qualifying for the study after the screening visit, patients will then be asked to stop taking their current phosphate binder for about 2 weeks. Then, if patients continue to qualify for the study, they will be entered in the study that lasts about 28 days. Study visits will happen every week during the patient's usual dialysis appointments. There will be a total of up to 9 visits for this study, and total participation time could last up to 8 weeks.

Arms: arm 1: 1 g/day KRX-0502 (ferric citrate) arm 2: 6 g/day KRX-0502 (ferric citrate) arm 3: 8 g/day KRX-0502 (ferric citrate)
Interventions: intervention 1: ferric citrate
Intervention descriptions: intervention 1: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days

Protocol documents:
Clinical trial NCT01080768
Conditions: Hypertension Ankle Edema
Keywords: Pedal edema hypertension aliskiren amlodipine
Sponsor: Novartis Pharmaceuticals
Start date: 2010-02-01; Completion date: 2010-11-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients.

Detailed description:

Arms: arm 1: During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.

The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day. arm 2: During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.

The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day.
Interventions: intervention 1: Aliskiren/amlodipine intervention 2: Amlodipine intervention 3: Placebo to Aliskiren/amlodipine intervention 4: Placebo to Amlodipine
Intervention descriptions: intervention 1: Aliskiren/amlodipine 150/5 mg/day intervention 2: Amlodipine 5 mg/day. intervention 3: Placebo to Aliskiren/amlodipine 150/10 mg/day intervention 4: Placebo to Amlodipine 5 mg/day

Protocol documents:
Clinical trial NCT01083485
Conditions: Post Operative Pain
Keywords: Oxycodone Naloxone Postoperative pain Arthroplasty Efficacy
Sponsor: Mundipharma Oy
Start date: 2010-03-01; Completion date: 2010-11-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that treatment with OXN PR tablets is non inferior to treatment with OXY PR tablets in terms of analgesic efficacy in patients with postoperative pain after knee arthroplasty based on average pain intensity scores.

Detailed description:

Arms: arm 1: Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages) arm 2: Oxycodone PR 20mg or 10mg (twice a day) BID for 2.5 days (total 5 dosages)
Interventions: intervention 1: Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets intervention 2: Oxycodone
Intervention descriptions: intervention 1: Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages)or Oxycodone 20mg intervention 2: Oxycodone 20mg or 10mg BID for 2.5 days (total 5 dosages)

Protocol documents:
Clinical trial NCT01085045
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Sponsor: Pearl Therapeutics, Inc.
Start date: 2010-03-01; Completion date: 2010-11-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.

Detailed description:

Arms: arm 1: PT003 MDI Dose 1 arm 2: PT003 MDI Dose 2 arm 3: PT005 MDI Dose 1 arm 4: PT005 MDI Dose 2 arm 5: Placebo MDI arm 6: Tiotropium Bromide inhalation powder arm 7: Formoterol fumarate inhalation powder 12 μg arm 8: PT001 MDI Dose 1
Interventions: intervention 1: PT003 MDI intervention 2: PT005 MDI intervention 3: Placebo MDI intervention 4: Tiotropium bromide 18 μg (Spiriva Handihaler®) intervention 5: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) intervention 6: PT001 MDI
Intervention descriptions: intervention 1: Inhaled PT003 MDI administered as two puffs BID for 7 days intervention 2: Inhaled PT005 MDI administered as two puffs BID for 7 days intervention 3: Inhaled placebo administered as two puffs BID for 7 days intervention 4: Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days intervention 5: Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days intervention 6: Inhaled PT001 MDI administered as two puffs BID for 7 days

Protocol documents:
Clinical trial NCT01100658
Conditions: ALL, Childhood Leukemia, Lymphoblastic Leukemia, Lymphoblastic, Acute Leukemia, Lymphoblastic, Acute, L1 Leukemia, Lymphoblastic, Acute, L2 Leukemia, Lymphoblastic, Acute, Philadelphia-Positive Leukemia, Lymphocytic, Acute Leukemia, Lymphocytic, Acute, L1 Leukemia, Lymphocytic, Acute, L2 Lymphoblastic Leukemia Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, Acute, Childhood Lymphoblastic Leukemia, Acute, L1 Lymphoblastic Leukemia, Acute, L2 Lymphoblastic Lymphoma Lymphocytic Leukemia, Acute Lymphocytic Leukemia, L1 Lymphocytic Leukemia, L2 Brain Tumors Cancer of the Brain Cancer of Brain Malignant Primary Brain Tumors Brain Neoplasms, Malignant
Sponsor: University of Minnesota
Start date: 2010-05-01; Completion date: 2010-11-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
While neurocognitive impairments in attention, memory and executive functioning are commonly reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to examine the treatment of attention deficits in this population. Numerous studies have examined the effectiveness of methylphenidate in the treatment of children with attention deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for improving attention and behavioral functioning in children with medical illnesses or brain injury are less clear.

Patients will be randomized to receive one week of Metadate CD (a controlled release form of methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.

Detailed description:

Arms: arm 1: Administered 1 capsule each day for 1 week, .3 mg/kg dose. arm 2: Administered 1 capsule each day for 1 week.
Interventions: intervention 1: Methylphenidate intervention 2: Placebo
Intervention descriptions: intervention 1: 1 capsule each day for 1 week, .3 mg/kg dose. intervention 2: 1 capsule per day for 1 week.

Protocol documents:
Clinical trial NCT01101061
Conditions: Osteopenia
Keywords: Amgen Phase 1 Postmenopausal Japanese
Sponsor: Amgen
Start date: 2010-05-03; Completion date: 2010-11-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The main purpose of this study is to assess the safety, tolerability and potential immune response to romosozumab following single subcutaneous (SC; injection under the skin) dose administration in healthy postmenopausal Japanese and non-Japanese women.

Detailed description:

Arms: arm 1: Japanese women in cohorts 1, 2, and 4 will receive a single dose of 1, 3, or 5 mg/kg romosozumab. Non-Japanese women in cohort 3 will receive a single dose of 3 mg/kg romosozumab. arm 2: Participants will receive a single dose of placebo.
Interventions: intervention 1: Romosozumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection

Protocol documents:
Clinical trial NCT01111318
Conditions: Hepatic Insufficiency Healthy
Sponsor: Boehringer Ingelheim
Start date: 2010-07-01; Completion date: 2010-11-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.

Detailed description:

Arms: arm 1: 50 mg single dose
Interventions: intervention 1: BI 10773
Intervention descriptions: intervention 1: 2 tablets BI 10773 25 mg single dose

Protocol documents:
Clinical trial NCT01130168
Conditions: Hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-05-01; Completion date: 2010-11-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will test the relationship between CBP (central blood pressure) and PBP (peripheral blood pressure) effects after single and multiple doses of Isosorbide mononitrate extended release (ISMN ER) or Amlodipine besylate in participants with hypertension.

Detailed description:

Arms: arm 1: Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period. arm 2: Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 3, with a 2-week washout between each period. arm 3: Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period. arm 4: Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period. arm 5: Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period. arm 6: Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule for 4 weeks during Period, with a 2-week washout between each period.
Interventions: intervention 1: Placebo intervention 2: Comparator: Amlodipine intervention 3: Comparator: ISMN ER
Intervention descriptions: intervention 1: Placebo, capsule taken orally once daily during 4 weeks of treatment intervention 2: Amlodipine 10 mg, taken orally as two 5 mg capsules, single daily dose for 4 weeks intervention 3: ISMN ER 30 mg capsule, taken orally as single daily dose for 4 weeks

Protocol documents:
Clinical trial NCT01145755
Conditions: Major Depressive Disorder
Keywords: Depression
Sponsor: AstraZeneca
Start date: 2010-05-01; Completion date: 2010-11-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.

Detailed description:
A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, parallel Group Study to Assess the Efficacy and Safety of AZD2066 after 6 weeks of treatment in Patients with Major Depressive Disorder - D0475C00020.

Arms: arm 1: None arm 2: None arm 3: Duloxetine
Interventions: intervention 1: AZD2066 intervention 2: Placebo intervention 3: Duloxetine
Intervention descriptions: intervention 1: 18 mg once daily intervention 2: None intervention 3: 60 mg once daily

Protocol documents:
Clinical trial NCT01145885
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2010-06-01; Completion date: 2010-11-01
Enrollment: 7 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Investigation of absorption, distribution, metabolism and excretion (ADME) and assessment of safety, tolerability and preliminary therapeutic effects of \[14C\]volasertib in patients with advanced solid tumours.

Detailed description:

Arms: arm 1: BI 6727 cycles in every 21 days
Interventions: intervention 1: BI 6727
Intervention descriptions: intervention 1: PLK-1 inhibitor

Protocol documents:
Clinical trial NCT01153958
Conditions: Vaginosis, Bacterial
Keywords: Vaginosis, Bacterial Colposeptine Metronidazole
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2010-07-01; Completion date: 2010-11-01
Enrollment: 133 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, randomized, controlled and multi-center trial to assess the use of colposeptine in female subjects with bacterial vaginosis. A total of 480 subjects were planned to be enrolled in various centers in China.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Colposeptine intervention 2: Metronidazole
Intervention descriptions: intervention 1: Colposeptine will be administered transvaginally at a dose of 1 capsule every day for 12 consecutive days intervention 2: Metronidazole will be administered orally at a dose of 400 mg twice a day for 7 days

Protocol documents: