ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00452335
Conditions: Constipation
Sponsor: Sucampo Pharma Americas, LLC
Start date: 2007-01-01; Completion date: 2008-10-01
Enrollment: 127 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.

Detailed description:

Arms: arm 1: Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\<6 years of age and able to swallow capsules) who are at least 12 kg body weight arm 2: Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight arm 3: Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
Interventions: intervention 1: Lubiprostone intervention 2: Lubiprostone intervention 3: Lubiprostone
Intervention descriptions: intervention 1: 12 mcg capsule once daily (QD) intervention 2: 12 mcg capsule twice daily (BID) intervention 3: 24 mcg capsule twice daily (BID)

Protocol documents:
Clinical trial NCT00455858
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2007-11-01; Completion date: 2008-10-01
Enrollment: 87 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: insulin detemir
Intervention descriptions: intervention 1: Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).

Protocol documents:
Clinical trial NCT00460551
Conditions: Non Small Cell Lung Cancer
Sponsor: Genmab
Start date: 2007-04-01; Completion date: 2008-10-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone.

Detailed description:
Originally the study was planned as Part 1A, Part 1B and Part 2. Part 1A was one arm with zalatumumab fixed dose 8 mg/kg. Part 1B was planned as zalutumumab dose-titration and Part 2 adding a comparator. The trial was prematurely closed for enrolment when patients had only been enrolled in Part 1A due to published results showing increased toxicity from induction chemotherapy without any survival benefit.

Arms: arm 1: None
Interventions: intervention 1: Zalutumumab intervention 2: Induction chemotherapy intervention 3: Radiotherapy
Intervention descriptions: intervention 1: 8 mg/kg intervention 2: Combination of cisplatin and docetaxel administered as two cycles given every three weeks intervention 3: 64 Gy in 32 fractions over 6.5 weeks

Protocol documents:
Clinical trial NCT00460746
Conditions: HIV
Keywords: HIV AIDS Immunodeficiency Virus, Human PREZISTA darunavir TMC114 TMC125 Protease Inhibitor Non-Nucleoside Reverse Transcriptase Inhibitor enfuvirtide Treatment Experienced
Sponsor: Tibotec, Inc
Start date: 2007-05-01; Completion date: 2008-10-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the safety, tolerability, and effectiveness of darunavir/ritonavir combined with TMC125 when current protease inhibitor(s), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI(s)) and enfuvirtide are replaced by darunavir/ritonavir and TMC125 in HIV positive patients who can no longer tolerate enfuvirtide and are experiencing viral suppression. Other antiviral drugs in the regimen are to remain unchanged.

Detailed description:
This is a multi-center, open-label (doctors and patients know which drug is being given), Phase IIIb clinical trial to evaluate the effectiveness, safety and tolerability of the combination of PREZISTA (darunavir)/ritonavir and TMC125 when substituted for enfuvirtide, current protease inhibitor(s) and Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI(s)) in antiretroviral resistant patients with viral suppression but who are intolerant of enfuvirtide. This study will be conducted in the U.S. at up to 5 sites where 40 patients will receive PREZISTA (darunavir) /ritonavir twice daily (600/100mg) and TMC125 (200 mg) twice daily over a 48-week treatment period.

The study will consist of a total of 11 patient visits. At the screening visit (Week -1 to -6) blood will be collected from patients to determine eligibility. Once all data are available to determine the eligibility of the patient, the baseline visit will be scheduled and trial treatment initiated at this visit. The Baseline Visit (Day 1) will be followed by a 48-week treatment period. The patient will be evaluated at Weeks 2, 4, 8, 12, 16, 24, 36, and 48. Patients will be asked to return for a 2-week follow up visit at Week 50.

Treatment will include PREZISTA (darunavir) /ritonavir and TMC125 plus continued nucleosides. The patient must continue all existing nucleosides in their background regimen for the duration of the study.

During the treatment period, the patient will be seen at regular visits during which the investigator will assess the patient's medical condition, any Adverse Events and study drug compliance. Laboratory evaluations for efficacy and safety will be done at regular visits. Study patients will receive oral (by mouth) PREZISTA (darunavir) 600 mg and 100 mg of ritonavir twice a day in combination with TMC125 200mg orally twice a day for 48 weeks.

Arms: arm 1: TMC125, Darunavir; RitonavirTMC125-200mg two times a day for 48 weeks; Darunavir -200mg two times a day for 48 weeks; Ritonavir-100mg two times a day for 48 weeks;
Interventions: intervention 1: TMC125, Darunavir; Ritonavir
Intervention descriptions: intervention 1: TMC125-200mg two times a day for 48 weeks; Darunavir -200mg two times a day for 48 weeks; Ritonavir-100mg two times a day for 48 weeks;

Protocol documents:
Clinical trial NCT00462670
Conditions: Edema, Cardiac
Keywords: Cardiac edema OPC-41061 Vasopressin antagonist
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2007-04-01; Completion date: 2008-10-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of 7-day repeated oral administration of OPC-41061 15 mg or placebo in congestive heart failure (CHF) patients with extracellular volume expansion despite the use of a conventional diuretic.

Detailed description:

Arms: arm 1: 0mg arm 2: 15mg OPC-41061
Interventions: intervention 1: OPC-41061(Tolvaptan)
Intervention descriptions: intervention 1: 0, 15mg of OPC-41061 per day for 7days p.o. administration

Protocol documents:
Clinical trial NCT00465985
Conditions: Muckle Wells Syndrome
Keywords: Muckle-Wells Syndrome children systemic autoinflammatory disease CIAS-1 gene NALP-3 ACZ885 human monoclonal anti-human interleukin-1beta (IL-1beta) antibody autosomal dominant familial autoinflammatory syndrome
Sponsor: Novartis
Start date: 2007-04-01; Completion date: 2008-10-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to provide efficacy and safety data for ACZ885 (a fully human anti-interleukin-1beta (anti-IL-1beta) monoclonal antibody) administered as an injection subcutaneously (s.c.) in patients with Muckle-Wells Syndrome.

Part I is an 8-week open-label, active treatment period to identify ACZ885 responders.

Part II is a double-blind, placebo-controlled period to assess primarily the efficacy of ACZ885 compared to placebo.

Part III is an open-label, active treatment period where patients will receive ACZ885 every 8 weeks after withdrawal or completion of Part II.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ACZ885 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00467740
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2007-05-01; Completion date: 2008-10-01
Enrollment: 296 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with asthma. The selection of the optimum dose(s) will be based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount of the medication found in your blood).

Detailed description:

Interventions: intervention 1: BI 1744 CL
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00471380
Conditions: Glaucoma Ocular Hypertension
Sponsor: Alcon Research
Start date: 2007-03-01; Completion date: 2008-10-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Double blind, crossover randomized, multicentric study to compare efficacy and tolerability of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed combination in patients with glaucoma or ocular hypertension

Detailed description:

Arms: arm 1: 3 period, 2 treatment cross-over model:

Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks) arm 2: 3 period, 2 treatment cross-over model:

Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).
Interventions: intervention 1: travoprost 0.004% and brinzolamide 1% intervention 2: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle
Intervention descriptions: intervention 1: Group A = concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) intervention 2: group B = fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).

Protocol documents:
Clinical trial NCT00474240
Conditions: Hypercholesterolemia
Keywords: cholesterol
Sponsor: Aegerion Pharmaceuticals, Inc.
Start date: 2007-04-01; Completion date: 2008-10-01
Enrollment: 157 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the effectiveness of the study drug, AEGR-733 alone and in combination with the medication, atorvastatin (Lipitor), on cholesterol in volunteers with moderately high cholesterol.

Detailed description:
Recent studies suggest more intensive cholesterol lowering treatment for people at very high risk of a heart attack, specifically for patients who have heart disease plus major risk factors. Available medications used alone at even the highest approved doses are not expected to reach these new target recommendations for cholesterol in a large number of subjects. Thus, the development of new medications that can provide additional cholesterol lowering may be beneficial.

This study tests the effectiveness of different doses of the study drug, AEGR-733 alone and in combination with the approved cholesterol lowering drug, atorvastatin (Lipitor), on cholesterol. Volunteers will be randomized to one of 6 different study treatments and will take the assigned medication (3 capsules daily) for 8 weeks.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: Atorvastatin 20 mg intervention 2: AEGR-733 5 mg intervention 3: AEGR-733 10 mg intervention 4: Placebo intervention 5: AEGR-733 5 mg + atorvastatin 20 mg intervention 6: AEGR-733 10 mg + atorvastatin 20 mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT00488059
Conditions: HIV Infections
Keywords: Treatment Experienced
Sponsor: Hoffmann-La Roche
Start date: 2007-06-01; Completion date: 2008-10-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study (Phase I), eligible patients received Fuzeon 90 mg subcutaneously (SC) twice daily until confirmation of response (min/max = 8/16 weeks). In Phase II, the randomised comparator phase of the study, responders were randomized to receive Fuzeon either 90 mg SC twice a day or 180 mg SC once a day for a further 16 weeks. Non-responders and virological failures were terminated from the study. The anticipated time on study treatment was 3-9 months, and the target sample size was 210 individuals.

Detailed description:

Arms: arm 1: Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® \[raltegravir\] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs). arm 2: In the randomized comparator Phase II of the trial- (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL from Phase I were randomized to 1 of 2 treatment arms of

(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs or (Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs.
Interventions: intervention 1: enfuvirtide [Fuzeon] intervention 2: Optimized background ARV intervention 3: Integrase inhibitor intervention 4: enfuvirtide [Fuzeon]
Intervention descriptions: intervention 1: 90 mg SC twice daily intervention 2: As prescribed intervention 3: As prescribed intervention 4: 180 mg SC once daily

Protocol documents:
Clinical trial NCT00490919
Conditions: Low Back Pain
Keywords: Chronic pain opioid transdermal Moderate to severe chronic low back pain
Sponsor: Purdue Pharma LP
Start date: 2007-06-01; Completion date: 2008-10-01
Enrollment: 539 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

Detailed description:
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Arms: arm 1: Buprenorphine transdermal system 10 or 20 mcg/h applied for 7-day wear arm 2: Placebo transdermal system to match BTDS patches, applied for 7 days
Interventions: intervention 1: Buprenorphine transdermal system intervention 2: Placebo
Intervention descriptions: intervention 1: Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days intervention 2: transdermal system (placebo) worn for 7 days

Protocol documents:
Clinical trial NCT00494026
Conditions: Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2007-09-01; Completion date: 2008-10-01
Enrollment: 4 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, phase II, open-label trial to evaluate the efficacy of pemetrexed + carboplatin combined with thoracic radiotherapy in patients with Limited Stage of small cell lung cancer

Detailed description:
Two 21-day cycles of pemetrexed (500 milligrams per square meter \[mg/m2\] intravenous \[IV\] infusion) and carboplatin (target area under the curve \[AUC\] 5 IV infusion) followed by two 21-day cycles of pemetrexed (500 mg/m2 IV infusion) and carboplatin (target AUC 5 IV infusion) with concurrent radiotherapy (2 Gray \[Gy\] per fraction, 5 fractions per week, up to a dose of 50 Gy is administered).

Arms: arm 1: None
Interventions: intervention 1: pemetrexed intervention 2: carboplatin intervention 3: radiotherapy
Intervention descriptions: intervention 1: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles intervention 2: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles intervention 3: 2 Gray (Gy) per fraction, 5 fractions per week, begin day 1, cycle 3 x 5 weeks (Monday-Friday)

Protocol documents:
Clinical trial NCT00495521
Conditions: Crohn's Disease
Keywords: Crohn's Crohn's Disease Acute Flare Mild to Moderate Crohn's Disease Children Pediatrics Ileo-cecal Pediatric Crohn's Disease New Onset Crohn's Disease Recently diagnosed Crohn's Disease
Sponsor: Jacobus Pharmaceutical
Start date: 2007-06-01; Completion date: 2008-10-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.

Detailed description:
Eligible pediatric patients with acute flares of ileocecal Crohn's disease will be randomized to receive either PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, or an identical-appearing placebo preparation.

Patients will be required to maintain a daily diary and to return at 2 weeks for blood and stool tests. At the four week mark, patients will return for clinical evaluation, global assessment of disease activity and change in disease activity, as well as additional laboratory tests.

Arms: arm 1: 4-Aminosalicylic acid extended release granules (as volume equivalent of active product), 50 mg/kg orally three times daily for two weeks followed by (as volume equivalent) 50 mg/kg orally two times daily for 2 weeks arm 2: Placebo granules identical in appearance to the active arm (as volume equivalent of active product), 0 mg/kg orally three times daily for two weeks followed by (as volume equivalent) 0 mg/kg orally two times daily for 2 weeks
Interventions: intervention 1: 4-Aminosalicylic acid extended release granules
Intervention descriptions: intervention 1: Granules for oral administration will be administered as a volume equivalent to 50 mg/kg of 4-aminosalicylic acid three times daily for 2 weeks followed by 2 times daily for 2 weeks in the active arm or a comparable volume in the placebo arm

Protocol documents:
Clinical trial NCT00509028
Conditions: Asthma
Keywords: Asthma Bronchial
Sponsor: AstraZeneca
Start date: 2006-12-01; Completion date: 2008-10-01
Enrollment: 241 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will include the patients who are Japanese children with bronchial asthma aged 5 years to 15 years old and have completed the Phase III study (Study code: D5254C00769) at about 29 centres. To investigate the safety of budesonide Turbuhaler® with a daily dose of 100 µg to 800 µg for 54 weeks treatment including the prior 6 weeks Phase III study (Study D5254C00769, NCT00504062) as compared with conventional therapy in Japanese children with bronchial asthma in need of inhaled glucocorticosteroid treatment.

Detailed description:

Arms: arm 1: Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily arm 2: Conventional Asthma Therapy - according to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
Interventions: intervention 1: Budesonide intervention 2: Conventional Asthma Therapy
Intervention descriptions: intervention 1: Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily intervention 2: According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Protocol documents:
Clinical trial NCT00510952
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes type 2
Sponsor: Eli Lilly and Company
Start date: 2007-08-01; Completion date: 2008-10-01
Enrollment: 471 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin glargine as basal insulin therapy in adults with type 2 diabetes.

Detailed description:

Arms: arm 1: Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks arm 2: Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
Interventions: intervention 1: Insulin Lispro Protamine Suspension intervention 2: Insulin Glargine
Intervention descriptions: intervention 1: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks intervention 2: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks

Protocol documents: