ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02731131
Conditions: Hepatitis D, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2004-09-01; Completion date: 2009-05-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD.

Detailed description:

Arms: arm 1: Participants will receive peginterferon alfa-2a alone, administered over 48 weeks. arm 2: Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks.
Interventions: intervention 1: Peginterferon alfa-2a intervention 2: Ribavirin
Intervention descriptions: intervention 1: Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection. intervention 2: Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses.

Protocol documents:
Clinical trial NCT00725764
Conditions: Neoplasms, Head and Neck
Keywords: VEGFR2 XL880 foretinib Squamous Cell Cancer of the Head and Neck MET GSK1363089
Sponsor: GlaxoSmithKline
Start date: 2007-08-27; Completion date: 2009-05-02
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is being conducted to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in adult subjects with squamous cell carcinoma of the head and neck (SCCHN). GSK1363089 is a new chemical entity that inhibits multiple receptor tyrosine kinases (RTKs) with growth-promoting and angiogenic properties. The primary targets of GSK1363089 are the HGF and vascular endothelial growth factor (VEGF) RTK families (eg, MET, VEGFR2/kinase insert domain receptor \[KDR\]). Since MET overexpression has been associated with poorer prognosis and MET tyrosine kinase mutations have been reported in SCCHN, inhibition of MET receptor and VEGFR2/KDR activation by agents such as GSK1363089 may be of therapeutic benefit in this patient population.

Detailed description:

Arms: arm 1: Participants who qualified for study entry received 240 mg of GSK1363089 (foretinib) on a 5-day on 9-day off schedule every 2 weeks.
Interventions: intervention 1: GSK1363089 (foretinib)
Intervention descriptions: intervention 1: Multitargeted tyrosine kinase inhibitor

Protocol documents:
Clinical trial NCT00724932
Conditions: Anesthesia, General
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-07-16; Completion date: 2009-05-03
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The current trial was designed to demonstrate faster recovery from a neuromuscular blockade (NMB) induced by rocuronium after reversal at 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 sugammadex compared to 50 µg.kg-1 neostigmine at reappearance of second twitch (T2) in participants undergoing laparoscopic cholecystectomy or appendectomy under propofol anesthesia, to compare safety and to evaluate operating room and Post Anesthetic Care Unit (PACU) length of stay.

Detailed description:
In those surgical procedures where a neuromuscular block is desired for intubation and/or avoid unwanted muscular activity, anesthesiologists may use a more profound NMB until the end of surgery, e.g. in open abdominal procedures or during laparoscopic procedures in order to improve surgical conditions. Reversal with sugammadex at a dose of 4.0 mg.kg-1 at 1-2 PTC after an intubation dose of 0.6 mg.kg-1 or maintenance dosing rocuronium has been found to be both safe and efficacious in previous clinical trials but has never been investigated exclusively in participants undergoing laparoscopic cholecystectomy or appendectomy.

With sugammadex profound muscle relaxation may now be provided right up to the end of the surgical procedure. This may lead to improved Patient Outcomes, such as improvement in the time from end of surgery to the discharge to the PACU. In this multi-center, randomized, parallel-group, active-controlled, safety-assessor blinded trial such benefits will be further investigated.

Arms: arm 1: 4.0 mg.kg-1 sugammadex at 1-2 PTC arm 2: 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
Interventions: intervention 1: Rocuronium intervention 2: Sugammadex intervention 3: Neostigmine intervention 4: Atropine
Intervention descriptions: intervention 1: Participants will receive an intravenous (i.v.) single bolus dose of 0.6 mg.kg-1 rocuronium. After this dose, maintenance doses of 0.1-0.2 mg.kg-1 rocuronium may be given. intervention 2: After the last dose of rocuronium has been administered, participants will receive, according to the randomization, a single bolus dose of 4.0 mg.kg-1 sugammadex at 1-2 PTC. intervention 3: After the last dose of rocuronium has been administered, participants will receive, according to the randomization, 50 μg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2. intervention 4: After the last dose of rocuronium has been administered, participants will receive, according to randomization, 10 μg.kg-1 atropine (with neostigmine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2.

Protocol documents:
Clinical trial NCT00528996
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2007-09-06; Completion date: 2009-05-05
Enrollment: 2080 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.

Detailed description:

Arms: arm 1: Matching Placebo arm 2: Low dose arm 3: Medium dose arm 4: High dose arm 5: Tiotropium Bromide
Interventions: intervention 1: BEA 2180 BR intervention 2: Tiotropium Bromide intervention 3: Placebo
Intervention descriptions: intervention 1: Solution intervention 2: Solution intervention 3: Solution

Protocol documents:
Clinical trial NCT00726388
Conditions: Pain, Postoperative
Keywords: safety diclofenac pain, postoperative
Sponsor: Pfizer
Start date: 2008-09-15; Completion date: 2009-05-08
Enrollment: 1050 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multiple-dose, safety study of DIC075V in patients with acute post-operative pain following abdominal or orthopedic surgery.

Detailed description:
This is an open-label, multiple-dose, multiple-day, single-arm safety study of repeat-doses of DIC075V in patients with acute post-operative pain following abdominal (i.e., non-laparoscopic abdominal surgeries) or orthopedic (e.g., hip or knee joint replacement) surgery. Eligible patients will receive DIC075V IV bolus q6 hours. Safety assessments will be collected at baseline (immediately prior to starting DIC075V therapy) and at study discharge or early termination.

Arms: arm 1: IV administration of multiple doses of DIC075V (intravenous diclofenac sodium) over multiple days
Interventions: intervention 1: DIC075V (intravenous diclofenac sodium)
Intervention descriptions: intervention 1: multiple doses up to 5 days

Protocol documents:
Clinical trial NCT00456092
Conditions: Psoriatic Arthritis
Keywords: psoriatic arthritis ACR PASI DAS pharmacokinetic biopsy
Sponsor: Amgen
Start date: 2007-03-05; Completion date: 2009-05-09
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to look at the preliminary efficacy and safety of 2 dose regimens of apremilast (20 mg twice a day and 40 mg once a day) versus placebo in patients with active psoriatic arthritis.

Detailed description:
Prior to the implementation of Amendment 1/UK3 the study consisted of 3 phases - pre-randomization up to 35 days, up to 84 days placebo-controlled treatment and a 28-day observational follow up. After the implementation of Amendment 1/UK3, the study consisted of 4 phases - pre-randomization up to 35 days, up to 84 days treatment in the placebo controlled treatment phase, up to 84 days treatment in the active treatment extension phase and a 28 day follow up. Participants who completed the treatment phase prior to implementation of amendment 1/UK3 did not have the option of entering the extension phase.

Arms: arm 1: Participants received 40 mg apremilast orally once a day (QD) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 40 mg apremilast QD for an additional 12 weeks.

The dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD during Days 4 to 7 and then 40 mg QD thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication. arm 2: Participants received 20 mg apremilast orally twice a day (BID) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 20 mg apremilast BID for an additional 12 weeks. The dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD during Days 4 to 7 and then 20 mg BID thereafter. A single dose reduction to 20 mg per day was allowed for participants who experienced intolerable adverse effects from study medication. arm 3: Participants received matching placebo to apremilast orally BID for 12 weeks during the Treatment Phase. Participants who entered the Extension Phase were re-randomized on Day 85 to receive either 40 mg apremilast QD or 20 mg apremilast BID for 12 weeks.
Interventions: intervention 1: Apremilast intervention 2: Placebo
Intervention descriptions: intervention 1: Capsules for oral administration intervention 2: Capsules for oral administration

Protocol documents:
Clinical trial NCT00882687
Conditions: Allergic Conjunctivitis
Sponsor: Shire
Start date: 2009-04-24; Completion date: 2009-05-10
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether SAR 1118 at three different concentrations, compared to placebo, is effective in the prevention of the signs and symptoms of allergic conjunctivitis

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Lifitegrast intervention 2: Placebo
Intervention descriptions: intervention 1: Ophthalmic Solution intervention 2: Ophthalmic Solution

Protocol documents:
Clinical trial NCT00415532
Conditions: Idiopathic Thrombocytopenic Purpura Thrombocytopenia Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenic Purpura
Keywords: splenectomy platelet AMG 531 thrombopoietin blood disorder bleeding disorder immune thrombocytopenic purpura idiopathic thrombocytopenic purpura immune (idiopathic) thrombocytopenic purpura TPO thrombopoietic protein
Sponsor: Amgen
Start date: 2006-12-01; Completion date: 2009-05-11
Enrollment: 234 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 3b, multi-center, randomized, Standard of Care (SOC)-controlled, open-label, 52-week treatment study to compare romiplostim to medical SOC for Idiopathic Thrombocytopenia Purpura (ITP), with a 6-month Safety Follow-up. Patients randomized to romiplostim must complete the taper or discontinuation of medical SOC for ITP as soon as medically feasible after the initiation of romiplostim. After the completion or discontinuation of the study treatment period, any participant who does not transfer in to another romiplostim study will complete a 6-month Safety Follow-up period.

Detailed description:

Arms: arm 1: Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks. arm 2: Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
Interventions: intervention 1: Medical Standard of Care for ITP intervention 2: Romiplostim
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00090259
Conditions: Heart Failure
Sponsor: Organon and Co
Start date: 2001-12-19; Completion date: 2009-05-13
Enrollment: 3834 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter study to evaluate potential decrease in hospitalization events and time between events and increasing longevity in patients with symptomatic congestive heart failure and intolerant of first-line medication for heart failure. This study will evaluate if higher doses of the investigational drug given daily will be superior to the lower dose of the same investigational drug given daily.

Detailed description:

Arms: arm 1: 50-mg losartan tablet administered daily with 1 tablet of 100-mg losartan placebo beginning Week 1 and continuing to end of study (up to 4 years) arm 2: Titrated losartan administration up to daily 150-mg losartan: Week 1, daily 50-mg losartan tablet coadministered with 100-mg losartan placebo; Week 2, daily 50-mg losartan placebo coadministered with 100-mg losartan; Week 3 to end of study (up to 4 years), daily 50-mg losartan tablet coadministered with 100-mg losartan
Interventions: intervention 1: Losartan 50 mg intervention 2: Losartan 150 mg
Intervention descriptions: intervention 1: 50-mg losartan oral tablet intervention 2: 100-mg losartan oral tablet + 50-mg losartan oral tablet

Protocol documents:
Clinical trial NCT00830076
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-12-02; Completion date: 2009-05-14
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will assess the effects of sitagliptin and metformin alone and after co-administration on incretin hormone concentrations in patients with Type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: Co-administration of sitagliptin and metformin arm 4: Co-administration of placebo to sitagliptin and placebo to metformin
Interventions: intervention 1: sitagliptin phosphate intervention 2: metformin hydrochloride intervention 3: Comparator: placebo sitagliptin intervention 4: Comparator: placebo metformin
Intervention descriptions: intervention 1: Sitagliptin 100 mg tablet on Day 1 and Day 2 in the morning. There will be a 7-day washout between treatment periods. intervention 2: Metformin 500 mg tablet in the morning and evening on Day 1 and two 500 mg tablets of metformin (total dose 1000 mg) on Day 2 in the morning. There will be a 7-day washout between treatment periods. intervention 3: Placebo to sitagliptin 100 mg in the morning on Days 1 and 2. There will be a 7-day washout between treatment periods. intervention 4: Placebo to metformin 500 mg tablet in the morning and evening on Day 1 and two placebo to metformin 500 mg tablets (1000 mg total dose) in the morning of Day 2. There will be a 7-day wash out between treatment periods.

Protocol documents:
Clinical trial NCT00797667
Conditions: Migraine
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-11-12; Completion date: 2009-05-20
Enrollment: 660 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to assess the safety and efficacy of MK0974 for preventing migraines in patients with episodic migraine.

Detailed description:

Arms: arm 1: Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks arm 2: Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks arm 3: Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
Interventions: intervention 1: Telcagepant 140 mg intervention 2: Telcagepant 280 mg intervention 3: 140 mg telcagepant placebo intervention 4: 280 mg telcagepant placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00828061
Conditions: Allergic Rhinitis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-02-04; Completion date: 2009-05-21
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will investigate whether changes in inflammatory mediators produced by the nose after exposure to an allergen can be used to evaluate the anti-inflammatory effects of novel drugs for the treatment of allergic asthma.

Detailed description:

Arms: arm 1: placebo arm 2: 10 mg prednisone arm 3: 25 mg prednisone
Interventions: intervention 1: Placebo intervention 2: prednisone intervention 3: prednisone
Intervention descriptions: intervention 1: Single dose of 5 tablets matching placebo (5 x 0 mg) to prednisone. The washout between treatment periods will be approximately 4 weeks intervention 2: Single dose of 5 tablets prednisone totaling 10 mg (3 x 0 mg + 2 x 5 mg). The washout between treatment periods will be approximately 4 weeks. intervention 3: Single dose of 5 tablets prednisone totaling 25 mg (5 x 5 mg). The washout between treatment periods will be approximately 4 weeks.

Protocol documents:
Clinical trial NCT00411645
Conditions: Cytomegalovirus Infections
Keywords: prevention prophylaxis Cytomegalovirus CMV allogeneic stem cell transplant SCT
Sponsor: Shire
Start date: 2006-12-13; Completion date: 2009-05-23
Enrollment: 681 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.

Detailed description:
Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and efficacy of maribavir for the prevention of CMV disease when given as prophylaxis for up to 12 weeks following allogeneic stem cell transplant.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: maribavir intervention 2: placebo
Intervention descriptions: intervention 1: 100 mg twice daily for up to 12 weeks intervention 2: twice daily for up to 12 weeks

Protocol documents:
Clinical trial NCT00457626
Conditions: Hypertension
Keywords: Children pediatrics High Blood Pressure Hypertension Valsartan
Sponsor: Novartis Pharmaceuticals
Start date: 2007-04-09; Completion date: 2009-05-25
Enrollment: 66 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.

Detailed description:

Arms: arm 1: Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg, escalated to 2 mg/kg or 4 mg/kg based on mean sitting systolic blood pressure (MSSBP) control after 2 weeks up to 18 weeks.
Interventions: intervention 1: Valsartan
Intervention descriptions: intervention 1: Extemporaneous suspension of valsartan, orally.

Protocol documents:
Clinical trial NCT00688376
Conditions: Attention Impairment
Keywords: Attention cancer chemotherapy donepezil acetylcholinesterase inhibitor
Sponsor: Eisai Inc.
Start date: 2008-07-02; Completion date: 2009-05-26
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil in children with persistent attention impairment that is present at least 12 months after the completion of cancer treatment.

Detailed description:
This is a double-blind, placebo-controlled, parallel group study in pediatric subjects who have persistent attention impairment following treatment for cancer. This trial has three phases: (1) pre-randomization to establish eligibility, (2) a 12-week, double-blind, placebo-controlled, parallel-group phase with dose escalation based on body weight, (3) a 12-week, blinded extension phase during which all subjects will receive active drug.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Donepezil hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: During the 12-week Double-Blind Phase, subjects will receive oral donepezil hydrochloride tablets starting at a dose of 3 mg once daily. Doses will be increased incrementally at successive 3-week intervals on the basis of weight and tolerability. The final daily dose will be 3, 5, or 10 mg depending on body weight.

During the Blinded Extension Phase, all subjects will receive active treatment (donepezil). intervention 2: During the 12-week Double-Blind Phase, subjects will receive matching placebo tablets (3, 5, of 10 mg) once daily.

During the 12-week Blinded Extension Phase, all subjects will receive active treatment (donepezil).

Protocol documents:
Clinical trial NCT00089661
Conditions: Breast Cancer Low Bone Mineral Density Osteopenia
Keywords: Breast Cancer Bone loss associated with Aromatase Inhibitor therapy (AIT) for non-metastatic BC osteopenia Low bone density
Sponsor: Amgen
Start date: 2004-10-01; Completion date: 2009-05-27
Enrollment: 252 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: AMG 162 / Denosumab
Intervention descriptions: intervention 1: 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months intervention 2: 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months

Protocol documents:
Clinical trial NCT04425746
Conditions: Patients Undergoing Photodynamic Therapy Using Porfimer Sodium
Sponsor: Clinuvel Pharmaceuticals Limited
Start date: 2008-08-05; Completion date: 2009-05-28
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of afamelanotide (previously developed as CUV1647) as adjunctive therapy in patients undergoing photodynamic therapy using porfimer sodium.

Detailed description:

Arms: arm 1: Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity. arm 2: Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.
Interventions: intervention 1: Afamelanotide intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: