ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01752634
Conditions: Psoriatic Arthritis
Keywords: Psoriatic arthritis, PsA, ACR, CASPAR, PASDAS
Sponsor: Novartis Pharmaceuticals
Start date: 2013-04-14; Completion date: 2019-01-09
Enrollment: 397 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was to provide 24 - 52 week efficacy, safety and tolerability data to support the registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self administration in subjects with active PsA despite current or previous NSAID, DMARD and/or anti-TNFα therapy. An additional 4 years of long-term efficacy and safety data were collected during the post Week 52 period of the study.

Detailed description:
At baseline (BSL), subjects whose eligibility was confirmed were randomized to one of the following four treatment groups.

* 75 mg secukinumab
* 150 mg secukinumab
* 300 mg secukinumab
* Placebo At Week 16, all subjects were classified as responders (≥ 20% improvement from BSL in both tender and swollen joint counts) or non-responders.

Subjects who were randomized to a secukinumab treatment group at baseline were targeted to remain on the same dose for the entire trial.

Subjects who were randomized to placebo at baseline were re-randomized at Week 16 as follows:

Placebo non-responders received secukinumab 150 mg s.c. or 300 mg s.c. (1:1) every 4 weeks, starting after the efficacy assessments at Week 16.

Placebo responders continued to receive placebo at Week 16 and Week 20 and received secukinumab 150 mg s.c. or 300 mg s.c. (1:1) every 4 weeks, starting after the efficacy assessments at Week 24.

This was a double-blind, double-dummy, randomized treatment trial until week 52 analysis was completed and open label afterwards.

An amendment to the study protocol (after all patients were in the trial for 2-3 years) introduced changes whereby patients previously treated with secukinumab 75 mg s.c. could change to receive 150 mg s.c. or 300 mg s.c., and patients previously treated with secukinumab 150 mg s.c. could change to receive 300 mg s.c., as deemed appropriate by the investigators.

Arms: arm 1: Secukinumab 75 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4. arm 2: Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4. arm 3: Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 arm 4: Placebo at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4. Non-responder (assessed at Week 16) were re-randomized to receive AIN457 150mg or AIN457 300 mg starting at Week 16. Responder (assessed at Week 16) were re-randomized to receive AIN457 150mg or AIN457 300 mg starting at Week 24.
Interventions: intervention 1: Secukinumab (AIN457) intervention 2: Placebo
Intervention descriptions: intervention 1: Secukinumab (AIN457) intervention 2: Placebo PFS for s.c. administration.

Protocol documents:
Clinical trial NCT02031458
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2014-01-22; Completion date: 2019-01-11
Enrollment: 667 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Atezolizumab
Intervention descriptions: intervention 1: 1200 mg IV every 3 weeks

Protocol documents:
Clinical trial NCT01611662
Conditions: Distal Urethral Cancer Proximal Urethral Cancer Squamous Cell Carcinoma of the Bladder Stage II Bladder Cancer Stage III Bladder Cancer Urethral Cancer Associated With Invasive Bladder Cancer
Sponsor: Fox Chase Cancer Center
Start date: 2012-05-29; Completion date: 2019-01-22
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to find out what effects, good and/or bad, dose-dense (every 14 days) chemotherapy with gemcitabine (gemcitabine hydrochloride) and cisplatin given before surgery have on patients and their muscle invasive bladder cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the rate of complete response (pT0) at cystectomy following preoperative dose dense gemcitabine and cisplatin (DD GC) in patients with muscle invasive urothelial carcinoma of the bladder.

SECONDARY OBJECTIVES:

I. To assess the toxicity profile of DD GC when given in the neoadjuvant setting: To define the number of patients who complete all three cycles of treatment without dose reduction, and to describe the incidence of toxicity.

II. To assess the 5 year overall and relapse free survival in patients who receive neoadjuvant DD GC.

TERTIARY OBJECTIVES:

I. To evaluate tissue specimens from patients to assess for molecular markers that correlate with clinical outcome.

OUTLINE:

Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.

After completion of study treatment, patients are followed up for 5 years.

Arms: arm 1: Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.
Interventions: intervention 1: gemcitabine hydrochloride intervention 2: cisplatin intervention 3: therapeutic conventional surgery intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Undergo radical cystectomy intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT01880528
Conditions: Dyspnea Non-small Cell Lung Cancer Small Cell Lung Cancer
Sponsor: Mayo Clinic
Start date: 2013-05-31; Completion date: 2019-01-29
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This pilot clinical trial studies lisinopril in reducing shortness of breath caused by radiation therapy in patients with lung cancer. Lisinopril may decrease the side effects caused by radiation therapy in patients with lung cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To explore the adverse event profile of lisinopril, during and after external beam radiation therapy (RT) to the lung.

SECONDARY OBJECTIVES:

I. To explore the level of patient-reported acute respiratory distress (dyspnea) during and after external beam RT.

II. To explore the level of patient-reported symptoms during and after external beam RT.

III. To explore the impact of lisinopril treatment on patient quality of life (QOL) during and after external beam RT.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Beginning within 7 days of beginning radiation therapy, patients receive lisinopril orally (PO) once daily (QD) on days 1-7.

ARM II: Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD on days 1-7.

In both arms, treatment repeats every 7 days for until 3 months after completion of radiation therapy in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD on days 1-7. arm 2: Beginning within 7 days of beginning radiation therapy, patients receive placebo PO QD on days 1-7.
Interventions: intervention 1: lisinopril intervention 2: placebo
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO

Protocol documents:
Clinical trial NCT01907191
Conditions: Hip Injuries
Keywords: Hip Arthroscopy Liposomal Bupivacaine Bupivacaine
Sponsor: Trinity Health Of New England
Start date: 2013-07-01; Completion date: 2019-01-30
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being undertaken to compare the pain control using either bupivacaine versus liposomal bupivacaine. Liposomal bupivacaine can potentially provide pain relief lasting up to 72 hours while regular bupivacaine can provide pain relief up to 12 hours

Detailed description:
Patients undergoing hip arthroscopy experience moderate to severe postoperative pain. Effective pain control after surgery is an important component in the overall management of these patients. Good pain control encourages early participation in rehabilitation program, increases success of the surgery, and improves patient satisfaction. Typically, postoperative analgesia is provided to these patients either with nerve blocks or opioid medications. Both these methods provide good pain relief but nerve blocks are associated with weakness of lower extremity muscles which interferes with early ambulation and increase the risk of falls while narcotic medications increase the risk of nausea, vomiting, itching, constipation, ileus, urinary retention, sedation and respiratory depression.

Arms: arm 1: Ultrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy arm 2: Bupivacaine (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy
Interventions: intervention 1: liposomal bupivacaine intervention 2: Bupivacaine
Intervention descriptions: intervention 1: (Ultrasound guided injection of liposomal bupivacaine) for patients undergoing hip arthroscopy intervention 2: (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
Title: Ultrasound Guided Local Infiltration Analgesia for Hip Arthroscopy 
 
PI: Sanjay K. Sinha, MD 
 
NCT01907191 
 
Document Date: June 11, 2013
Clinical trial NCT03093259
Conditions: Ulcerative Colitis
Keywords: ABX464 Ulcerative Colitis Refractory
Sponsor: Abivax S.A.
Start date: 2017-11-16; Completion date: 2019-02-04
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in subjects with moderate to severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids followed by a one-month follow-up period.

Detailed description:
This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in subjects with moderate to severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids followed by a one-month follow-up period.

Eligible subjects will be randomized according to a 2/1 ratio in two different groups of treatment. Randomized subjects who will receive 50 mg ABX464 orally once daily for 56 days.

Arms: arm 1: Subjects will receive 50 mg of ABX464 orally once daily for 56 days. arm 2: Subjects will receive 50 mg of ABX464 matching Placebo orally once daily for 56 days.
Interventions: intervention 1: ABX464 intervention 2: Placebo oral capsule
Intervention descriptions: intervention 1: ABX464 is a new Anti-inflammatory drug intervention 2: Placebo matching with ABX464

Protocol documents:
Prot_000.pdf: 







































































































SAP_001.pdf:
Clinical trial NCT01889862
Conditions: Phenylketonuria (PKU)
Keywords: PKU PEG-PAL Prism BioMarin rAvPAL-PEG BMN165
Sponsor: BioMarin Pharmaceutical
Start date: 2013-07-29; Completion date: 2019-02-05
Enrollment: 215 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The BMN 165 clinical development program has been designed to demonstrate the safety and efficacy of BMN 165 in reducing blood Phe concentrations in adults with PKU.

Detailed description:
165-302 is a Phase 3, 4 Part, Randomized, Double-Blind, Placebo-Controlled, Discontinuation Study to Evaluate the Efficacy and Safety of Self Administered Subcutaneous Injections of BMN 165 by Adults With PKU.

This study is open only to adults who have been exposed to BMN165 in a previous study.

Study BMN 165-302 is a four-Part, Phase 3 study.

* Part 1: Open-label period
* Part 2: A Randomized, double-blind, placebo-controlled period of 8 weeks
* Part 3: Two sub-Parts to Part 3:- Part 3A - BMN 165 administered using vial and syringe during this open label period. Part 3B - BMN 165 administered using prefilled syringe during this open-label period.
* Part 4: A long-term, open-label extension period.

Arms: arm 1: BMN165 20mg/day self-administered daily arm 2: 20 mg/day Placebo self-administered daily arm 3: BMN165 40mg/day self-administered daily arm 4: 40 mg/day Placebo self-administered daily
Interventions: intervention 1: BMN165 20mg/day intervention 2: BMN165 40mg/day intervention 3: Placebo
Intervention descriptions: intervention 1: BMN165 20mg/day self-administered daily intervention 2: BMN165 40mg/day self-administered daily intervention 3: Non-drug placebo, self-administered daily

Protocol documents:
Clinical trial NCT02320487
Conditions: Chronic Lymphocytic Leukemia
Sponsor: Genentech, Inc.
Start date: 2015-03-31; Completion date: 2019-02-06
Enrollment: 102 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 2, open-label, multicenter study to evaluate the safety and efficacy of BG induction therapy in participants with previously untreated CLL. The anticipated time on study treatment is 24 weeks.

Detailed description:

Arms: arm 1: Participants received obinutuzumab + bendamustine (BG) induction therapy in 28-day cycles for 6 cycles.
Interventions: intervention 1: Bendamustine intervention 2: Obinutuzumab
Intervention descriptions: intervention 1: Bendamustine was administered as an intravenous infusion at a dose of 90 milligrams per square meter (mg/m\^2) on Days 2 and 3 Cycle 1; and on Days 1 and 2 Cycles 2-6. intervention 2: Obinutuzumab was administered as an intravenous infusion at a dose of 100 milligrams (mg) on Day 1 Cycle 1; at a dose of 900 mg on Day 2 Cycle 1; at a dose of 1000 mg on Days 8 and 15 Cycle 1, and Day 1 Cycles 2-6.

Protocol documents:
Clinical trial NCT00875056
Conditions: Lymphoma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-04-15; Completion date: 2019-02-08
Enrollment: 56 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vorinostat (MK-0683) in participants with relapsed and/or refractory follicular lymphoma. The exploratory purpose of this study is to evaluate efficacy of MK-0683 in participants with relapsed/refractory non-FL indolent B-NHL or relapsed/refractory MCL. The primary hypothesis is that MK-0683 will show efficacy in relapsed/refractory FL patients as measured by the Overall Response Rate.

Detailed description:

Arms: arm 1: Participants with relapsed/refractory FL received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. arm 2: Participants with indolent non-follicular lymphoma (FL) B-cell non-Hodgkin's lymphoma (B-NHL), or with mantle cell Lymphoma (MCL) received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. arm 3: Participants with disease other than relapsed/refractory follicular lymphoma (FL), non-FL B-cell non-Hodgkin's lymphoma (B-NHL), or mantle cell Lymphoma (MCL), as assessed by the Independent Central Pathological Committee, received 200 mg of vorinostat (MK-0683) twice daily (200 mg x 2/day) for 14 consecutive days followed by 1 week (7 days) rest in a 21-day cycle, until they met the per-participant discontinuation criteria specified by the protocol. This group was created to include participants who enrolled, but whose later diagnoses by the Independent Central Pathological Committee excluded them from analysis in the FL and non-FL B-NHL/MCL groups because they had different disease than those prespecified in the protocol.
Interventions: intervention 1: Vorinostat
Intervention descriptions: intervention 1: Two 100 mg oral capsules of vorinostat, twice daily (400 mg/day), on Days 1 through 14 of each 21 day cycle

Protocol documents:
Clinical trial NCT02325219
Conditions: Psoriasis
Keywords: Psoriasis CNTO 1959 Guselkumab Placebo
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2014-12-19; Completion date: 2019-02-08
Enrollment: 192 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate the superiority of CNTO 1959 (guselkumab) to placebo in the treatment of participants with moderate to severe plaque-type psoriasis (A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches).

Detailed description:
A Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know about the study treatment), placebo-controlled (a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect) study of CNTO 1959 (Guselkumab) in the treatment of participants with moderate to severe plaque-type psoriasis. Participants will receive either treatment of CNTO 1959 (guselkumab) 50 milligram (mg) or 100 mg or Placebo 50 mg or 100 mg. Participants will primarily be assessed for Investigator's Global Assessment (IGA) Score and Psoriasis Area and Severity Index (PASI). Participants' safety will be monitored throughout the study.

Arms: arm 1: Participants will receive subcutaneous injection of CNTO 1959 50 milligram (mg) and placebo 100 mg at Week 0, 4 and then every 8 weeks thereafter. arm 2: Participants will receive subcutaneous injection of CNTO 1959 100 milligram (mg) and placebo 50 mg at Week 0, 4 and then every 8 weeks thereafter. arm 3: Participants will receive subcutaneous injection of placebo 50 mg and 100 mg at Weeks 0, 4 and 12. At Week 16, participants will be randomized in sub-group 3a to receive either CNTO1959 50 mg and placebo 100 mg at Week 16, 20 and then every 8 weeks thereafter or sub-group 3b to receive CNTO 1959 100 mg and placebo 50 mg at Week 16, 20 and then every 8 weeks thereafter.
Interventions: intervention 1: CNTO 1959 50 mg intervention 2: CTNO 1959 100 mg intervention 3: Placebo 50 mg intervention 4: Placebo 100 mg
Intervention descriptions: intervention 1: Participants will receive subcutaneous injection of CNTO 1959 50 mg. intervention 2: Participants will receive subcutaneous injection of CNTO 1959 100 mg. intervention 3: Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 50 mg. intervention 4: Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 100 mg.

Protocol documents:
Clinical trial NCT00979992
Conditions: Ovarian Clear Cell Adenocarcinoma Recurrent Ovarian Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2010-04-19; Completion date: 2019-02-09
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies the side effects of sunitinib malate and how well it works in treating patients with ovarian cancer that is persistent or has come back. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the anti-tumor activity of SU11248 (sunitinib malate), a highly potent, selective tyrosine kinases inhibitor, in patients with persistent or recurrent clear cell ovarian carcinoma.

II. To examine the nature and degree of toxicity in this cohort of patients treated with this regimen.

SECONDARY OBJECTIVES:

I. To characterize the distribution of progression-free survival and overall survival for patients treated with SU11248 (sunitinib malate).

TERTIARY OBJECTIVES:

I. To determine the pre-cycle 1, pre-cycle 4 and off-treatment levels of pro-angiogenic proteins (e.g., angiogenin, soluble vascular cell adhesion molecule \[VCAM\]-I, basic fibroblast growth factor \[bFGF\], platelet-derived growth factor \[PDGF\], placental growth factor \[PlGF\], vascular endothelial growth factor \[VEGF\], and hypoxia-inducible factor \[HIF\]1alpha).

II. To identify changes in serum and plasma angiogenesis markers at baseline (pre-cycle 1), during treatment (cycle 4), and at progression in association with primary and secondary clinical endpoints associated with clinical response or progression-free survival.

OUTLINE:

Patients receive sunitinib malate orally (PO) once daily (QD) for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Arms: arm 1: Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Sunitinib Malate
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO

Protocol documents: