ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03034460
Conditions: Acne
Sponsor: Galderma R&D
Start date: 2016-04-25; Completion date: 2016-11-02
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using intra-individual comparison involving subjects with acne vulgaris on face to evaluate the efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.

Detailed description:
Study drugs application will be performed once daily, 5 days a week during 6 weeks

Arms: arm 1: Active drug; arm 2: Placebo of active drug; arm 3: Positive control; arm 4: Placebo of positive control;
Interventions: intervention 1: CD5024 1% cream intervention 2: CD5024 cream placebo intervention 3: CD0271/CD1579 gel intervention 4: CD0271/CD1579 gel placebo
Intervention descriptions: intervention 1: 500 µL on half-face, five days a week during 6 weeks intervention 2: 500 µL on half-face, five days a week during 6 weeks intervention 3: 500 µL on half-face, five days a week during 6 weeks intervention 4: 500 µL on half-face, five days a week during 6 weeks

Protocol documents:
Clinical trial NCT00577629
Conditions: Lymphoma, B-Cell
Keywords: high risk non-hodgkins lymphoma NHL Bexxar high dose chemotherapy
Sponsor: Duke University
Start date: 2005-06-18; Completion date: 2016-11-03
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk Non-Hodgkin's Lymphoma (NHL).

Detailed description:
This is a phase II efficacy trial for patients with untreated, high-risk, B-cell Non-Hodgkin's Lymphoma. The study will evaluate the efficacy and safety of high-dose chemotherapy combined with monoclonal antibodies and targeted radioimmunotherapy in previously untreated patients with high-risk NHL

Arms: arm 1: Induction:Cyclophosphamide, Etoposide, and Rituxan (rituximab) followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar (tositumomab)
Interventions: intervention 1: cyclophosphamide intervention 2: etoposide intervention 3: rituximab intervention 4: cytarabine intervention 5: doxorubicin intervention 6: tositumomab
Intervention descriptions: intervention 1: 1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2 intervention 2: 300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2. intervention 3: 375mg/m2 each week x 4 weeks of induction, beginning on day 1 intervention 4: 3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses intervention 5: 45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation intervention 6: 450mg unlabeled tositumomab over 1 hour, followed by 5 millicurie (mCi) Iodine I-131 labeled tositumomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.

Protocol documents:
Clinical trial NCT01305213
Conditions: Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2011-03-21; Completion date: 2016-11-03
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well bevacizumab with or without fosbretabulin tromethamine works in treating patients with ovarian epithelial, fallopian tube, or peritoneal cavity cancer that has come back or is persistent. Monoclonal antibodies, such as bevacizumab, find tumor cells and help kill them. Bevacizumab and fosbretabulin tromethamine may stop the growth of ovarian cancer by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more effective with or without fosbretabulin tromethamine in treating ovarian epithelial, fallopian tube, and peritoneal cavity cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the progression-free survival hazard ratio of the combination of bevacizumab and fosbretabulin tromethamine (CA4P) compared to bevacizumab alone in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer.

SECONDARY OBJECTIVES:

I. To determine the nature and degree of toxicity of fosbretabulin tromethamine plus bevacizumab.

II. To characterize and compare progression-free survival in patients with measurable disease (Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) and patients with detectable (non-measurable) disease between regimens.

III. To determine the overall survival for both regimens. IV. To estimate the proportion of patients with measurable disease who have objective tumor responses by treatment.

V. To provide descriptive information about cancer antigen (CA)-125 responses by regimen and where possible by objective tumor responses.

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

ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive bevacizumab IV over 30-90 minutes and fosbretabulin tromethamine IV over 10-20 minutes on day 1. Courses repeat every 21 days 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 bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive bevacizumab IV over 30-90 minutes and fosbretabulin tromethamine IV over 10-20 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Bevacizumab intervention 2: Fosbretabulin Tromethamine intervention 3: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01559129
Conditions: Scleroderma, Systemic Sclerosis, Systemic Systemic Scleroderma Systemic Sclerosis Interstitial Lung Disease
Sponsor: Celgene
Start date: 2012-08-09; Completion date: 2016-11-03
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the safety, tolerability, and efficacy of pomalidomide in the treatment of patients with systemic sclerosis with interstitial lung disease.

Detailed description:

Arms: arm 1: None arm 2: Participants received 1 mg pomalidomide orally once a day for 52 weeks during the treatment phase and for up to 2 years during the open-label extension phase.
Interventions: intervention 1: Pomalidomide (CC-4047) intervention 2: Placebo
Intervention descriptions: intervention 1: 1 mg orally every day for 52 weeks intervention 2: Matching placebo capsules taken orally once a day

Protocol documents:
Clinical trial NCT02021643
Conditions: Chronic HCV Infection
Sponsor: Gilead Sciences
Start date: 2013-12-10; Completion date: 2016-11-03
Enrollment: 687 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 Hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: Participants with genotype 1 or 6 will receive sofosbuvir+RBV+Peg-IFNα-2a for 12 weeks. arm 2: Participants with genotype 1, 2 or 6 will receive sofosbuvir+RBV for 12 weeks. arm 3: Participants with genotype 1, 6 will receive sofosbuvir+RBV for 16 weeks. arm 4: Participants with genotype 1, 3, or 6 will receive sofosbuvir+RBV for 24 weeks.
Interventions: intervention 1: Sofosbuvir intervention 2: RBV intervention 3: PEG
Intervention descriptions: intervention 1: Sofosbuvir 400 mg tablet administered orally once daily intervention 2: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) intervention 3: Pegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week

Protocol documents:
Clinical trial NCT02221674
Conditions: Moderate to Severe Acute Postoperative Pain
Keywords: Post-surgical pain Opioid
Sponsor: Grünenthal GmbH
Start date: 2014-11-05; Completion date: 2016-11-03
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, open-label (all people involved know the identity of the intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how are they distributed within the body and how are they removed from the body over time) in children aged from birth to less than 2 years after a surgical procedure that routinely produces moderate to severe acute post-surgical pain.

The trial will also evaluate the safety and tolerability of tapentadol oral solution in the population studied and the effect of tapentadol oral solution on pain.

Detailed description:
This clinical trial has 3 phases: enrollment, treatment (15 hours) and follow up.

During the enrolment phase consent and eligibility will be determined. After surgery, the participant will be given routine pain medication as per standard of care in the hospital.

Treatment phase: When the participant has a functioning gastrointestinal tract after surgery, can tolerate medication administered orally or via a feeding tube, meets the inclusion criteria, and does not meet any exclusion criterion, the participant will be allocated to the investigational medicinal product (IMP). Evaluations will be performed over the next 15 hours, including the assessment of the amount of pain. During this time, 2 blood samples will be taken for testing of the amount of tapentadol and its main metabolites in the participant's blood.

A final follow-up visit is planned to take place up to 2 weeks after taking the trial medication.

Arms: arm 1: Tapentadol 4 mg/mL immediate release oral solution, single dose post-operatively.
Interventions: intervention 1: Tapentadol
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02064439
Conditions: Pulmonary Embolism Thromboembolism Thrombosis Venous Thrombosis Venous Thromboembolism
Keywords: deep vein thrombosis pulmonary embolism long-term prevention of recurrent symptomatic VTE
Sponsor: Bayer
Start date: 2014-03-05; Completion date: 2016-11-04
Enrollment: 3365 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy.

Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial

Detailed description:

Arms: arm 1: Rivaroxaban 10 mg once daily for 12 months arm 2: Rivaroxaban 20 mg once daily for 12 months arm 3: ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months
Interventions: intervention 1: BAY 59-7939 intervention 2: BAY 59-7939 intervention 3: ASA
Intervention descriptions: intervention 1: 10 mg tablet once daily for 12 months intervention 2: 20 mg tablet once daily for 12 months intervention 3: 100 mg tablet once daily for 12 months

Protocol documents:
Clinical trial NCT01818752
Conditions: Multiple Myeloma
Sponsor: Amgen
Start date: 2013-07-08; Completion date: 2016-11-04
Enrollment: 955 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).

Detailed description:

Arms: arm 1: Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m². arm 2: Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
Interventions: intervention 1: Carfilzomib intervention 2: Bortezomib intervention 3: Melphalan intervention 4: Prednisone
Intervention descriptions: intervention 1: Carfilzomib was administered over 30 minutes on days 1, 2, 8, 9, 22, 23, 29, and 30 for nine 42-day cycles. Carfilzomib 20 mg/m² IV was administered on days 1 and 2 of cycle 1, followed by escalation to 36 mg/m² IV starting on day 8 of cycle 1. intervention 2: Bortezomib 1.3 mg/m² was administered as a bolus IV injection or as a subcutaneous injection (per investigator's choice, dose modification, or regulatory approval) on days 1, 4, 8, 11, 22, 25, 29, and 32 of cycles 1 to 4, and on days 1, 8, 22, and 29 of cycles 5 to 9. intervention 3: Melphalan 9 mg/m² was taken orally on days 1 to 4 of all cycles. intervention 4: Prednisone 60 mg/m² was taken orally on days 1 to 4 of all cycles.

Protocol documents:
Clinical trial NCT02019277
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2013-12-05; Completion date: 2016-11-04
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, multicenter, Phase IIIb study will assess the safety, tolerability and efficacy of a combination therapy of intravenous (IV) pertuzumab (Perjeta), trastuzumab (Herceptin) SC, and taxane chemotherapy (docetaxel, paclitaxel or nab-paclitaxel) as first-line therapy in participants with HER2-positive metastatic breast cancer (mBC). All participants will be treated with 3-week cycles of pertuzumab IV (840 milligrams \[mg\] first dose; subsequent doses of 420 mg) and trastuzumab SC (600 milligrams \[mg\]). The taxane treatment regimen will be determined by the investigator. Participants will continue therapy until disease progression, unacceptable toxicity, or the participant withdraws consent, whichever occurs first.

Detailed description:

Arms: arm 1: Participants will receive pertuzumab, trastuzumab and a taxane (docetaxel, paclitaxel or nab-paclitaxel) once every 3 weeks (21-day cycles). Choice of taxane will be at the discretion of the investigator and administered per routine clinical practices and local prescribing instructions.
Interventions: intervention 1: Docetaxel intervention 2: Nab-paclitaxel intervention 3: Paclitaxel intervention 4: Pertuzumab intervention 5: Trastuzumab
Intervention descriptions: intervention 1: Dosing regimen to be determined by the investigator, routine clinical practices. intervention 2: Dosing regimen to be determined by the investigator, routine clinical practices. intervention 3: Dosing regimen to be determined by the investigator, routine clinical practices. intervention 4: Pertuzumab will be administered on Day 1 of the first treatment cycle as a loading dose of 840 mg, followed by 420 mg as an IV infusion every 3 weeks. intervention 5: Trastuzumab will be administered at a fixed dose of 600 mg SC every 3 weeks.

Protocol documents:
Clinical trial NCT02068157
Conditions: Recurrent Laryngeal Squamous Cell Carcinoma Recurrent Laryngeal Verrucous Carcinoma Recurrent Lip and Oral Cavity Squamous Cell Carcinoma Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary Recurrent Oral Cavity Verrucous Carcinoma Recurrent Oropharyngeal Squamous Cell Carcinoma Tongue Carcinoma
Sponsor: Roswell Park Cancer Institute
Start date: 2014-04-01; Completion date: 2016-11-04
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies the effects of interstitial photodynamic therapy in patients with head and neck cancer that has come back. Interstitial photodynamic therapy uses a combination of laser light and a light-sensitive drug called porfimer sodium to destroy tumors. During treatment a laser light is used to activate the drug. Interstitial photodynamic therapy may be an effective treatment for head and neck cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. Demonstrate that our image-guided interstitial photodynamic therapy (I-PDT) dosimetry system can be used to tailor this therapy to individual patients.

OUTLINE:

Patients receive porfimer sodium intravenously (IV) over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.

After completion of study, patients are followed up at 1 month, 2 months, 4 months, and then every 2 months for up to 12 months.

Arms: arm 1: Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Photodynamic Therapy intervention 3: Porfimer Sodium
Intervention descriptions: intervention 1: Correlative studies intervention 2: Undergo image-guided I-PDT intervention 3: Given IV

Protocol documents:
Clinical trial NCT02612610
Conditions: Refractory Chronic Cough
Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2015-12-15; Completion date: 2016-11-04
Enrollment: 253 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the efficacy of three dose regimens of gefapixant (\[MK-7264\] 7.5 mg, 20 mg, and 50 mg) relative to placebo in reducing awake objective cough frequency. The primary hypothesis for this trial is that at least one dose regimen of gefapixant is superior to placebo with respect to the mean change from baseline in awake cough frequency (on the log scale).

Detailed description:

Arms: arm 1: Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks. arm 2: Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks. arm 3: Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks. arm 4: Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
Interventions: intervention 1: Gefapixant intervention 2: Placebo (for gefapixant)
Intervention descriptions: intervention 1: Gefapixant administered as one 7.5 mg, 20 mg, or 50 mg tablet twice daily, depending upon randomization. intervention 2: None

Protocol documents:
Clinical trial NCT02766777
Conditions: Constipation - Functional
Sponsor: Sucampo Pharma Americas, LLC
Start date: 2016-04-12; Completion date: 2016-11-04
Enrollment: 87 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to \< 18 years diagnosed with functional constipation.

Detailed description:
To assess the long-term safety and tolerability of oral lubiprostone 12 or 24mcg capsules dosed twice daily (BID) when administered orally for 24 weeks in pediatric participants with functional constipation. Evaluation of lubiprostone safety and tolerability is the primary objective in this study.

Arms: arm 1: Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks.
Interventions: intervention 1: Lubiprostone
Intervention descriptions: intervention 1: 12 or 24 mcg soft capsules for oral administration.

Protocol documents:
Clinical trial NCT00688623
Conditions: Advanced and Metastatic Silent Neuro-Endocrine Tumors Carcinoma Neuroendocrine Non Functioning Neuroendocrine Tumors (NETs) Non Syndromic Neuroendocrine Tumors Carcinoids Non Functioning
Keywords: Neuroendocrine tumors non functioning neuroendocrine tumors Non syndromic neuroendocrine tumors carcinoids non-functioning carcinoids adults everolimus NET RAMSETE CRAD001 non-functioning neuroendocrine tumors carcinoids
Sponsor: Novartis Pharmaceuticals
Start date: 2009-06-24; Completion date: 2016-11-07
Enrollment: 73 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.

Detailed description:

Arms: arm 1: Everolimus
Interventions: intervention 1: Everolimus
Intervention descriptions: intervention 1: Everolimus 5 mg tablets were supplied in blister packs

Protocol documents:
Clinical trial NCT01928485
Conditions: Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer
Sponsor: Sanjay Gupta PhD
Start date: 2013-08-30; Completion date: 2016-11-07
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well green tea extract works in treating patients with low-risk prostate cancer. Green tea extract contains ingredients that may prevent or slow the growth of certain cancers.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess changes in the levels of total- and free- prostate-specific antigen (PSA), free to total PSA (f/tPSA) ratio and insulin-like growth factor 1 (IGF-I) levels and IGF-I/free PSA (fPSA) ratio, insulin-like growth factor binding protein 3 (IGFBP-3), and vascular endothelial growth factor (VEGF) after Sunphenon 90DCF-T (green tea extract) supplementation during the period between recruitment and biopsy.

SECONDARY OBJECTIVES:

I. To evaluate the effects of oral ingestion on Sunphenon 90DCF-T supplementation during the period between recruitment and biopsy in the reactivation of glutathione S-transferase pi 1 (GSTP1) (whole blood deoxyribonucleic acid \[DNA\]); levels of antigen identified by monoclonal antibody Ki-67 (Ki-67), cluster of differentiation 34 (CD34), and M30 apopotosense in the prostate tissue.

II. To evaluate the effects of oral ingestion of Sunphenon 90DCF-T during the period between recruitment and biopsy on histologic findings in prostate tissue such as nuclear measurements viz. shape, size and texture and quality of life (QOL) assessment.

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

ARM A: Patients undergo active surveillance for 52 weeks.

ARM B: Patients receive green tea extract orally (PO) once daily (QD) for 52 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Arms: arm 1: Patients undergo active surveillance for 52 weeks. arm 2: Patients receive Sunphenon PO QD for 52 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: active surveillance intervention 2: Sunphenon intervention 3: laboratory biomarker analysis intervention 4: Questionnaire Administration
Intervention descriptions: intervention 1: Undergo active surveillance intervention 2: Given PO intervention 3: Correlative studies intervention 4: Ancillary studies

Protocol documents: