ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02459418
Conditions: Healthy Volunteers
Keywords: Afolia Follitropin
Sponsor: Fertility Biotech AG
Start date: 2015-05-07; Completion date: 2016-05-19
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Comparative PK study after single SC application of Afolia and the reference product (US Gonal-f®). Objective: To demonstrate equivalence within 80%-125% margin of the reference product for the area under the curve (AUC) of Afolia.

Detailed description:
To demonstrate equivalence within the 80% to 125% margin of the reference product for the baseline corrected area under the follicle-stimulating hormone (FSH) serum concentration-time curve from time zero to the last quantifiable concentration of AFOLIA compared to the reference product (United States \[US\] Gonal-f® RFF)

Arms: arm 1: During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive treatment sequence: (Sequence A): Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27. arm 2: During the Cross-Over Pharmacokinetic Phase, patients will be randomly assigned to receive treatment sequence (Sequence B): Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27
Interventions: intervention 1: Afolia intervention 2: US Gonal-f®
Intervention descriptions: intervention 1: During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive one of the following treatment sequences:

Sequence A: Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.

Sequence B: Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27 intervention 2: During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive one of the following treatment sequences:

Sequence A: Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.

Sequence B: Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27

Protocol documents:
Clinical trial NCT00545714
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Sponsor: Hoffmann-La Roche
Start date: 2007-11-21; Completion date: 2016-05-20
Enrollment: 86 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide, followed by rituximab maintenance therapy, as first line treatment of participants with CLL.

Detailed description:

Arms: arm 1: Participants will receive 6 cycles (cycle length = 28 days) of treatment with rituximab (375 milligrams per square meter \[mg/m\^2\] as intravenous \[IV\] infusion on Day 0 of Cycle 1 and 500 mg/m\^2 as IV infusion on Day 1 of Cycles 2-6); fludarabine (25 mg/m\^2 on Days 1-3) and cyclophosphamide (250 mg/m\^2 on Days 1-3). Participants with a partial or complete response and appropriate neutrophil conditions will receive maintenance treatment with rituximab (375 mg/m\^2 as IV infusion every 2 months) from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6.
Interventions: intervention 1: Cyclophosphamide intervention 2: Fludarabine intervention 3: Rituximab
Intervention descriptions: intervention 1: Cyclophosphamide 250 mg/m\^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles. intervention 2: Fludarabine 25 mg/m\^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles. intervention 3: Rituximab 375 mg/m\^2 as IV infusion will be administered on Day 0 of Cycle 1; 500 mg/m\^2 as IV infusion will be administered on Day 1 of Cycle 2-6; and 375 mg/m\^2 as IV infusion every 2 months from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6.

Protocol documents:
Clinical trial NCT01798056
Conditions: Herpes Zoster Herpes Zoster Vaccine
Keywords: ≥18 years of age Chemotherapy Solid tumours Immunogenicity Herpes Zoster Safety Shingles
Sponsor: GlaxoSmithKline
Start date: 2013-03-06; Completion date: 2016-05-20
Enrollment: 237 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults with solid tumours undergoing chemotherapy.

Detailed description:
The study will be randomised into two groups based on the vaccination schedule in relation to the start of a chemotherapy cycle:

* The OnChemo group receives their first HZ/su vaccination at the start of a chemotherapy cycle,
* The PreChemo group receives their first HZ/su vaccination at least 10 days before the start of a chemotherapy cycle.

The protocol summary has been updated following Protocol Amendment 2, August 2014, leading to the increase of the enrolment.

Arms: arm 1: Subjects received the first dose of GSK 1437173A at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of GSK 1437173A vaccine was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients. arm 2: Subjects received the first dose of placebo at least 10 days (up to 1 month) before start of chemotherapy cycle or at the first day (allowing a window of +/- 1 day) of the first (or second) chemotherapy cycle. The second dose of placebo was administered between 1 and 2 months after the first vaccination and at the first day (allowing a window of +/- 1 day) of a subsequent cycle of chemotherapy. The study products were administered intramuscularly into a deltoid muscle. The choice of and use of chemotherapy, or any other medication related to the patients' current conditions, were based on the local standard of care for the patients.
Interventions: intervention 1: GSK 1437173A intervention 2: Placebo
Intervention descriptions: intervention 1: 2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm. intervention 2: 2 doses administered by IM injection into the deltoid muscle of the non-dominant arm.

Protocol documents:
Clinical trial NCT02153632
Conditions: Parkinson's Disease Levodopa Induced Dyskinesia (LID)
Keywords: Parkinson's Disease Levodopa Induced Dyskinesia (LID) LID Parkinsonism Dyskinesia
Sponsor: Adamas Pharmaceuticals, Inc.
Start date: 2014-07-30; Completion date: 2016-05-20
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this multi-center, randomized, double-blind, parallel-group, 26 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.

Detailed description:
This study was terminated early due to slow enrollment with 135 of 162 planned subjects enrolled. Amantadine HCl ER has been used for many years as a treatment for Parkinson's disease. It has been reported in the literature to effectively treat the motor complications of levodopa, especially dyskinesia, but it must be given 2 to 4 times a day. The purpose of this multi-center, randomized, double-blind, parallel-group, 26 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease. The dose will be given once a day in the morning so that amantadine concentrations are maintained throughout the day for treating the levodopa induced dyskinesia, but will be lower during the night, potentially reducing the negative impact of amantadine on sleep.

Arms: arm 1: amantadine HCl ER, 240 mg tablets, once daily, 22 weeks arm 2: amantadine HCl ER, 320 mg tablets, once daily, 22 weeks arm 3: Placebo, tablets, once daily, 26 weeks.
Interventions: intervention 1: amantadine HCl ER intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects are given either 240 mg amantadine HCl ER tablet or 320 mg amantadine HCl ER tablet intervention 2: subjects are given an identical placebo tablet

Protocol documents:
Clinical trial NCT02153645
Conditions: Parkinson's Disease Levodopa Induced Dyskinesias (LID)
Keywords: Parkinson's Disease Levodopa Induced Dyskinesias (LID) Dyskinesias Parkinsonism
Sponsor: Adamas Pharmaceuticals, Inc.
Start date: 2014-08-18; Completion date: 2016-05-20
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was terminated early due to slow enrollment with 87 of 162 planned subjects enrolled. The purpose of this multi-center, randomized, double-blind, parallel-group, 16 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.

Detailed description:
This study was terminated early due to slow enrollment with 87 of 162 planned subjects enrolled. Amantadine has been used for many years as a treatment for Parkinson's disease. It has been reported in the literature to effectively treat the motor complications of levodopa, especially dyskinesia, but it must be given 2 to 4 times a day. The purpose of this multi-center, randomized, double-blind, parallel-group, 16 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease. The dose will be given once a day in the morning so that amantadine concentrations are maintained throughout the day for treating the levodopa induced dyskinesia, but will be lower during the night, potentially reducing the negative impact of amantadine on sleep.

Arms: arm 1: Amantadine HCl ER Tablets 240mg daily for 12 weeks post two week titration phase. arm 2: Amantadine HCl ER Tablets 320mg daily for 12 weeks post a two week dose titration phase. arm 3: Placebo Tablets matching Amantadine HCl ER Tablets taken daily for 16 weeks.
Interventions: intervention 1: 240mg Amantadine HCl ER tablets intervention 2: Placebo tablets intervention 3: 320mg Amantadine HCl ER tablets
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01607957
Conditions: Colorectal Cancer
Keywords: Refractory, metastatic colorectal cancer
Sponsor: Taiho Oncology, Inc.
Start date: 2012-06-17; Completion date: 2016-05-23
Enrollment: 800 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer.

Detailed description:
This is a multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison study evaluating the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer. Patients will be randomly assigned (2:1) to TAS-102 (experimental arm) or placebo (control arm).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: TAS-102 intervention 2: Placebo
Intervention descriptions: intervention 1: 35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met. intervention 2: Placebo tablets, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.

Protocol documents:
Clinical trial NCT02227368
Conditions: Peripheral Artery Disease (PAD)
Keywords: Myocardial Infarction Peripheral Arterial disease Mycardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Altherosclerosis Arteriosclerosis Arterial Occlusive Diseases Peripheral Vascular Diseases Ticagrelor Ticlopidine Platelet Aggregation inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinegic P2Y Receptor Antagonists Purinegic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Actions Physiological Effects of Drugs Fibrinolytic Agents Crardiovascular Agents
Sponsor: AstraZeneca
Start date: 2014-10-20; Completion date: 2016-05-23
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the effect of ticagrelor versus aspirin on the change in peak walking time, evaluated on the graded treadmill test, from one to 26 weeks post-revascularization in patients with peripheral artery disease who have undergone endovascular revascularization for moderate to severe claudication or ischemic rest pain.

Detailed description:
A Phase II Multicentre, Randomised, Double-Blind, Controlled, Parallel-Group Study to Evaluate the Walking Time Effect of Long-Term Ticagrelor in Comparison to Long-Term Aspirin Administration in Ambulatory Patients with Peripheral Artery Disease Undergoing Endovascular Revascularization - The Ticagrelor in Peripheral Artery Disease Endovascular Revascularization Study TI-PAD I EVR.

Arms: arm 1: 26 Weeks of ticagrelor 90mg twice a day plus aspirin placebo once daily arm 2: 26 Weeks of aspirin 100mg once daily plus ticagrelor placebo twice a day
Interventions: intervention 1: Ticagrelor intervention 2: Comparator
Intervention descriptions: intervention 1: Antiplatelet therapy approved for ACS. Antagonist of P2Y12 and inhibitor of adenosine diphosphate (ADP)-induced platelet aggregation. intervention 2: Aspirin monotherapy anti-platelet treatment for PAD patients following EVR procedures

Protocol documents:
Clinical trial NCT02203032
Conditions: Psoriasis
Keywords: Psoriasis Plaque-type psoriasis Guselkumab Ustekinumab CNTO 1959 Monoclonal antibody
Sponsor: Janssen Research & Development, LLC
Start date: 2014-10-07; Completion date: 2016-05-24
Enrollment: 872 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to ustekinumab.

Detailed description:
This is a randomized (assignment of study drug by chance), double-blind (participants nor study staff will know the identity of study drugs), multicenter study to evaluate efficacy and safety of guselkumab for the treatment of participants with moderate to severe plaque-type psoriasis who had an inadequate response to ustekinumab. The study will consist of a screening period, open-label and double-blind treatment periods, and a follow-up period. The treatment period will have 2 phases: an open-label treatment phase during which all participants will receive ustekinumab at Weeks 0 and 4 and a blinded treatment phase during which participants with an inadequate Investigator's Global Assessment response (IGA≥2) to ustekinumab at Week 16 will be randomized to receive either guselkumab or ustekinumab through Week 44. Participants with an IGA response of 0 or 1 (cleared or minimal disease) at Week 16 will continue to receive open-label treatment with ustekinumab every 12 weeks through Week 40. All participants will complete a follow-up phase through Week 52 for efficacy and through Week 60 for safety evaluations. The total duration of the study will be approximately 64 weeks (includes a 4-week screening period). Participants' safety will be monitored throughout the study.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Ustekinumab intervention 2: Guselkumab intervention 3: Placebo for ustekinumab intervention 4: Placebo for guselkumab
Intervention descriptions: intervention 1: 45 mg or 90 mg given by subcutaneous injection at Weeks 0 and 4 for all participants. Participants with an IGA score of 0 or 1 at Week 16 will also receive ustekinumab every 12 weeks (q12w) from Week 16 to Week 40. intervention 2: 100 mg given by subcutaneous injection at Weeks 16 and 20 and every 8 weeks (q8w) thereafter through Week 44. intervention 3: Subcutaneous injection at Weeks 16, 28, and 40 to maintain the blind for participants randomized to treatment with guselkumab. intervention 4: Subcutaneous injection at Weeks 16 and 20 and q8w thereafter through Week 44 to maintain the blind for participants randomized to treatment with ustekinumab.

Protocol documents:
Clinical trial NCT02271945
Conditions: Relapsed/Refractory Aggressive B-cell Lymphomas
Keywords: aggressive lymphoma, DLBCL, NHL
Sponsor: MedImmune LLC
Start date: 2014-12-01; Completion date: 2016-05-24
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 1b/2 open-label study to evaluate the safety/efficacy of MEDI-551 + MEDI0680 in participants with relapsed or refractory aggressive B-cell lymphomas who have failed 1-2 prior lines of therapy.

Detailed description:
This is a Phase 1b/2, multicenter, open-label, study of MEDI-551 in combination with immunomodulating therapy evaluating the safety, tolerability, pharmacokinetics, immunogenicity and anti-tumor activity in subjects with relapsed or refractory aggressive B-cell lymphomas

Arms: arm 1: Participants will receive intravenous (IV) infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13. arm 2: Participants will receive IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
Interventions: intervention 1: MEDI-551 12 mg/kg intervention 2: MEDI0680 2.5 mg/kg intervention 3: MEDI0680 10 mg/kg
Intervention descriptions: intervention 1: Participants will receive intravenous (IV) infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 intervention 2: Participants will receive IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13. intervention 3: Participants will receive IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.

Protocol documents:
Clinical trial NCT02092285
Conditions: Ulcerative Colitis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-05-09; Completion date: 2016-05-25
Enrollment: 205 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the efficacy of golimumab in maintaining a clinical response in participants with moderate-to-severe ulcerative colitis.

Detailed description:
This study consists of a 1 week screening period, a 54 week treatment period, and a 12 week follow-up period, requiring a total of 7 trial site visits: Visit 1(screening visit, Week -1), Visit 2 (enrollment visit, Day 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 5 (Week 30) and Visit 6 (Week 54) and Visit 7 (follow-up visit, Week 66).

Arms: arm 1: The first induction dose of subcutaneous (SC) golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received a maintenance dose of golimumab (50 mg for participants with a body weight \<80 kg or 100 mg for participants with a body weight ≥80 kg) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
Interventions: intervention 1: Golimumab
Intervention descriptions: intervention 1: 50mg or 100mg solution for injection; subcutaneous injection

Protocol documents:
Clinical trial NCT00727506
Conditions: Glioma
Sponsor: Boehringer Ingelheim
Start date: 2008-07-14; Completion date: 2016-05-25
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase I Part: To determine the maximum tolerated dose (MTD) and pharmacokinetics of BIBW 2992 administered in combination with TMZ in patients with recurrent malignant gliomas (WHO Grade III and IV).

Phase II Part: To estimate the efficacy and safety of BIBW 2992 monotherapy and BIBW 2992 / TMZ combination therapy compared to TMZ monotherapy (three treatment arms) in patients with recurrent GBM. To evaluate molecular determinants of response to BIBW 2992.

Detailed description:

Arms: arm 1: BIBW 2992 once daily arm 2: TMZ 21/28 days arm 3: BIBW 2992 once daily plus TMZ 21/28 days
Interventions: intervention 1: BIBW 2992 intervention 2: TMZ intervention 3: BIBW 2992 plus TMZ
Intervention descriptions: intervention 1: BIBW 2992 once daily intervention 2: TMZ 21/28 intervention 3: BIBW 2992 once daily plus TMZ 21/28 days

Protocol documents:
Clinical trial NCT02253654
Conditions: Renal Insufficiency, Chronic Anemia Renal Dialysis Erythrocyte Transfusion
Keywords: Chronic Kidney Disease Anemia Hemodialysis Red Blood Cell Transfusion
Sponsor: Amgen
Start date: 2015-04-01; Completion date: 2016-05-25
Enrollment: 216 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare two different dosing methods of epoetin alfa and their effectiveness in maintaining hemoglobin levels between 10.0 to 11.0 g/dL in in patients with chronic kidney disease (CKD) receiving hemodialysis.

Detailed description:

Arms: arm 1: Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories. arm 2: Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
Interventions: intervention 1: Epoetin alfa
Intervention descriptions: intervention 1: Administered intravenously (IV) three times a week (TIW) by appropriately trained healthcare professionals during hemodialysis.

Protocol documents: