ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01287741
Conditions: Diffuse Large B-Cell Lymphoma
Sponsor: Hoffmann-La Roche
Start date: 2011-07-26; Completion date: 2018-01-31
Enrollment: 1418 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m\^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.

Detailed description:

Arms: arm 1: Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy. arm 2: Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Interventions: intervention 1: Rituximab intervention 2: Obinutuzumab intervention 3: Cyclophosphamide intervention 4: Doxorubicin intervention 5: Vincristine intervention 6: Prednisone
Intervention descriptions: intervention 1: Rituximab at a dose of 375 mg/m\^2, administered by intravenous (IV) infusion on Day 1 of each 21-day cycle for 8 cycles. intervention 2: Obinutuzumab 1000 mg IV infusion, administered on Day 1 of each 21-day cycle for 8 cycles. During Cycle 1, obinutuzumab was also infused on Days 8 and 15. intervention 3: Cyclophosphamide 750 milligrams per square metre (mg/m\^2), administered intravenously (IV) on Day 1 of each 21-day cycle. intervention 4: Doxorubicin 50 mg/m\^2 IV, administered on Day 1 of each 21-day cycle. intervention 5: Vincristine 1.4 mg/m\^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle. intervention 6: Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.

Protocol documents:
Clinical trial NCT02226172
Conditions: Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
Keywords: Primary myelofibrosis Secondary myelofibrosis PMF PET-MF PPV-MF Ruxolitinib resistant or intolerant previously treated myelofibrosis smoothened inhibitor oral single agent.
Sponsor: Pfizer
Start date: 2014-10-06; Completion date: 2018-01-31
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A lead-in cohort of \~20 patients with primary or secondary myelofibrosis previously treated with 1 or more Janus kinase inhibitors enrolled to single-agent glasdegib to evaluate safety and tolerability. Following the lead-in, a phase 2, double blind, 2-arm study, randomized 2:1 to oral single-agent glasdegib versus placebo in 201 patients resistant or intolerant to ruxolitinib.

Detailed description:

Arms: arm 1: Oral daily dose of glasdegib (PF-04449913) 100 mg tablet in a continuous regimen of 28-day cycles. arm 2: Oral daily dose of placebo 100 mg tablet in a continuous regimen of 28-day cycles.
Interventions: intervention 1: Glasdegib (PF-04449913) intervention 2: Placebo
Intervention descriptions: intervention 1: Oral daily dose of glasdegib (PF-04449913) 100 mg tablet in a continuous regimen of 28-day cycles. intervention 2: Oral daily dose of placebo 100 mg tablet in a continuous regimen of 28-day cycles.

Protocol documents:
Clinical trial NCT00043108
Conditions: Lung Cancer
Keywords: stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer
Sponsor: Fox Chase Cancer Center
Start date: 2002-07-01; Completion date: 2018-02-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy with radiation therapy before and after surgery may shrink the tumor so it can be removed during surgery and may kill any remaining tumor cells following surgery.

PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and carboplatin with radiation therapy and surgery in treating patients who have newly diagnosed locally advanced non-small cell lung cancer.

Detailed description:
OBJECTIVES:

* Determine the complete resection rate and toxic death rate of patients with locally advanced non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy followed by surgical resection and adjuvant paclitaxel and carboplatin.
* Determine the survival, event-free survival, and incidence of pathologic complete remission of patients treated with this regimen.
* Determine the protocol completion rate (CR) of patients treated with this regimen.
* Determine the feasibility and toxicity of this regimen in these patients.
* Determine the pathologic response rate/downstaging, pathologic near CR rate, freedom from distant metastasis rate, and freedom from local regional failure rate of patients treated with this regimen.

OUTLINE: Patients receive induction therapy comprising radiotherapy 5 days a week for 5.5-6 weeks and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36.

Within 1-3 weeks after completion of induction therapy, patients undergo restaging. Patients with resectable disease undergo surgical resection within 4-8 weeks after induction therapy. Patients with unresectable disease undergo additional radiotherapy 5 days a week for 3 weeks and receive paclitaxel and carboplatin as in induction therapy on days 1, 8, and 15.

Within 4-12 weeks after surgery or additional chemoradiotherapy, patients receive adjuvant therapy comprising paclitaxel and carboplatin as in induction therapy on day 1. Adjuvant treatment repeats every 4 weeks for 3 courses.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 57 patients will be accrued for this study within 4 years.

Arms: arm 1: Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6)
Interventions: intervention 1: carboplatin intervention 2: paclitaxel intervention 3: conventional surgery intervention 4: radiation therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Prot_SAP_ICF_000.pdf:
Clinical trial NCT01468454
Conditions: Congenital Hyperinsulinism (CHI) Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
Keywords: Congenital Hyperinsulinism (CHI) hyperinsulinism Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI) CHI PHHI Pancreatectomy 18F-DOPA PET/CT scan
Sponsor: Children's Hospital of Philadelphia
Start date: 2009-01-01; Completion date: 2018-02-01
Enrollment: 130 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery to remove part or all of their pancreas. In this study, researchers will test how well a radioactive drug, 18-labeled L-fluorodeoxyphenylalanine (called F-DOPA) can detect a form of hyperinsulinism (focal HI) that may be cured by surgery. Eligible participants in this study will have positron emission tomography/computerized tomography (PET/CT) scans with F-DOPA prior to surgery.

Detailed description:
For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas (called diffuse disease); others have them located in specific areas of the pancreas (called focal disease). Children who have focal disease located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that is picked up by these cells and used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will validate the efficacy and safety of using PET/CT with F-DOPA in the pre-operative localization of focal disease in children with hyperinsulinism.

Arms: arm 1: Obtain safety and efficacy data on the use of 18-labeled L-fluorodeoxyphenylalanine (18F-DOPA) PET imaging in children with HI for the clinical indication of localizing a focal lesion
Interventions: intervention 1: 18 F-DOPA
Intervention descriptions: intervention 1: 1 time injection of 0.08 - 0.16 mCi/kg of 18F-DOPA

Protocol documents:
Clinical trial NCT01521949
Conditions: Prostate Cancer
Keywords: Prostate Cancer Nutraceutical Acai Juice
Sponsor: University of Colorado, Denver
Start date: 2011-11-04; Completion date: 2018-02-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Men who have Prostate Specific Antigen (PSA) recurrence with low PSA levels and long doubling times do not require immediate treatment with androgen deprivation therapy and may be safely observed. In these situations where current treatment options may cause more unnecessary side effects than anticipated benefit, it is reasonable to use a low-risk natural product such as Acai Juice Product with antioxidant properties to evaluate whether there are any anti-cancer effects.

Detailed description:
In this study, patients who meet eligibility criteria will take Acai Juice 2 ounces by mouth twice daily on a continuous basis.

Arms: arm 1: 2 ounces of Acai Juice Product by mouth twice daily.
Interventions: intervention 1: Acai Juice Product
Intervention descriptions: intervention 1: 2 ounces of Acai Juice Product twice daily.

Protocol documents:
Clinical trial NCT01565941
Conditions: Heart Failure Respiratory Failure
Keywords: Cardiovascular Respiratory Failure Heart Lung Continuous glucose monitoring Tight glycemic control Subcutaneous Insulin Algorithm
Sponsor: Boston Children's Hospital
Start date: 2012-04-01; Completion date: 2018-02-01
Enrollment: 713 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Stress hyperglycemia, a state of abnormal metabolism with supra-normal blood glucose levels, is often seen in critically ill patients. Tight glycemic control (TGC) was originally shown to reduce morbidity and mortality in a landmark randomized clinical trial (RCT) of adult critically ill surgical patients but has since come under intense scrutiny due to conflicting results in recent adult trials. One pediatric RCT has been published to date that demonstrated survival benefit but was complicated by an unacceptably high rate of severe hypoglycemia. The Heart And Lung Failure - Pediatric INsulin Titration (HALF-PINT) trial is a multi-center, randomized clinical treatment trial comparing two ranges of glucose control in hyperglycemic critically ill children with heart and/or lung failure. Both target ranges of glucose control fall within the range of "usual care" for critically ill children managed in pediatric intensive care units.

The purpose of the study is to determine the comparative effectiveness of tight glycemic control to a target range of 80-110 mg/dL (TGC-1, 4.4-6.1 mmol/L) vs. a target range of 150-180 mg/dL (TGC-2, 8.3-10.0 mmol/L) on hospital mortality and intensive care unit (ICU) length of stay (LOS) in hyperglycemic critically ill children with cardiovascular and/or respiratory failure. This will be accomplished using an explicit insulin titration algorithm and continuous glucose monitoring to safely achieve these glucose targets. Both groups will receive identical standardized intravenous glucose at an age-appropriate rate in order to provide basal calories and mitigate hypoglycemia. Insulin infusions will be titrated with an explicit algorithm combined with continuous glucose monitoring using a protocol that has been safely implemented in 490 critically ill infants and children.

Detailed description:

Arms: arm 1: Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm. arm 2: Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.
Interventions: intervention 1: Insulin intervention 2: Insulin
Intervention descriptions: intervention 1: IV insulin titration to target a blood glucose of 80-110 mg/dL intervention 2: IV insulin titration to target a blood glucose of 150-180 mg/dL

Protocol documents:
Clinical trial NCT01626664
Conditions: Adult T-cell Leukemia-Lymphoma
Keywords: Adult T cell Leukemia-Lymphoma (ATL)
Sponsor: Kyowa Kirin, Inc.
Start date: 2012-06-01; Completion date: 2018-02-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to estimate the overall response rate of subjects with relapsed or refractory Adult T-cell Leukemia-Lymphoma (ATL).

Detailed description:
CCR4 expression in ATL patients has been demonstrated to be very high and has been associated with shorter survival compared with CCR4-negative patients. KW-0761, a monoclonal antibody targeted to CCR4, has been shown to be safe and tolerable in several clinical trials in subjects with a variety of T-cell malignancies, including ATL, mycosis fungoides and Sézary syndrome. The objective of this study is to estimate the overall response rate of KW-0761 for subjects with relapsed or refractory ATL.

Arms: arm 1: anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab) arm 2: Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP
Interventions: intervention 1: KW-0761 intervention 2: Pralatrexate intervention 3: gemcitabine plus oxaliplatin intervention 4: DHAP
Intervention descriptions: intervention 1: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression intervention 2: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression intervention 3: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression intervention 4: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression

Protocol documents:
Clinical trial NCT02123849
Conditions: Lung Carcinoma Tobacco Use Disorder
Sponsor: National Cancer Institute (NCI)
Start date: 2014-06-01; Completion date: 2018-02-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies the safety and effects of acetylsalicylic acid (aspirin) taken continuously or intermittently on gene expression in the nasal tissue of current smokers. Smokers are at increased risk of developing lung cancer. Acetylsalicylic acid may be useful in preventing lung cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To analyze the impact of a 12-week intervention of intermittent and continuous acetylsalicylic acid (ASA) on a smoking-related gene expression signature in the nasal epithelium of current smokers and to analyze any difference between the intermittent and continuous ASA interventions.

SECONDARY OBJECTIVES:

I. To determine whether the change in the smoking-related gene expression signature of nasal epithelium persists one week off agent intervention.

II. To compare the change in urinary prostaglandin E metabolite (PGE-M) and leukotriene E (4) (LTE \[4\]) between the continuous and intermittent dosing arms and to determine whether the change persists one week off agent intervention.

III. To analyze the impact of intermittent and continuous ASA on a three lung cancer-related gene signatures (an 80-gene signature, a phosphoinositide 3-kinase \[PI3K\] gene signature, and a nasal epithelium cancer signature) in the nasal epithelium and to analyze any difference between the intermittent and continuous ASA interventions.

IV. To determine whether the change, if any, in the lung cancer-related gene expression signatures of nasal epithelium persists one week off agent intervention.

V. To compare the safety in current smokers of 12 week exposure to continuous versus intermittent ASA.

VI. To evaluate a gender effect in the modulatory effects of intermittent and continuous ASA on smoking-related gene expression signature.

VII. To explore in a discovery-driven fashion the effect of ASA intervention on whole-genome gene expression.

VIII. To analyze the impact of intermittent and continuous ASA on karyometric analysis of buccal cells and to analyze any difference between intermittent and continuous ASA interventions.

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

ARM I (CONTINUOUS): Participants receive aspirin orally (PO) once daily (QD) for 12 weeks.

ARM II (INTERMITTENT): Participants receive placebo PO QD during weeks 1, 3, 5, 7, 9, and 11 and aspirin PO QD during weeks 2, 4, 6, 8, 10, and 12.

After completion of study treatment, participants are followed up for 2 weeks.

Arms: arm 1: Participants receive aspirin PO QD for 12 weeks. arm 2: Participants receive placebo PO QD during weeks 1, 3, 5, 7, 9, and 11 and aspirin PO QD during weeks 2, 4, 6, 8, 10, and 12.
Interventions: intervention 1: Aspirin intervention 2: Laboratory Biomarker Analysis intervention 3: Placebo
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Given PO

Protocol documents:
Clinical trial NCT02809118
Conditions: Hearing Loss, Idiopathic Sudden Sensorineural
Keywords: Deafness Hearing Loss Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Sensation Disorders Signs and Symptoms Hearing and Speech Impairment Hearing Loss, Unilateral
Sponsor: Auris Medical, Inc.
Start date: 2016-06-01; Completion date: 2018-02-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).

Detailed description:
This is a Phase III, randomized, double-blind, placebo-controlled, parallel group, multi-center, efficacy and safety trial of AM-111 in the treatment of subjects suffering from severe to profound idiopathic sudden sensorineural hearing loss.

The active pharmaceutical ingredient of AM-111 is a JNK inhibitor (D-JNKI-1), a synthetic peptide consisting of 31 D-amino acids, which acts as a c-Jun N-terminal kinase (JNK) ligand.

The study consists of one treatment visit and a follow-up period until day 91.

Study participants will receive, after topical anesthesia of the tympanic membrane, AM-111 0.4 mg/mL or 0.8 mg/mL or placebo, administered into the affected ear. Following the administration, subjects will rest in a supine or reclined position for 30 minutes. Study participants will have the option for a course of oral corticosteroids.

Arms: arm 1: Placebo gel for intratympanic use arm 2: AM-111 gel for intratympanic use (0.4 mg/ml AM-111) arm 3: AM-111 gel for intratympanic use (0.8 mg/ml AM-111)
Interventions: intervention 1: AM-111 0.4 mg/ml intervention 2: AM-111 0.8 mg/ml intervention 3: Placebo
Intervention descriptions: intervention 1: AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia intervention 2: AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia intervention 3: Placebo gel is administered with a single dose into the affected ear after topical anesthesia

Protocol documents:
Prot_000.pdf: 

















































































































































































SAP_001.pdf:
Clinical trial NCT03097068
Conditions: Diabetic Macular Edema
Sponsor: Vitreo-Retinal Associates, Michigan
Start date: 2017-04-19; Completion date: 2018-02-02
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The protocol will measure a number of cytokines in addition to vascular endothelial growth factor in response to 0.3mg Lucentis.

Detailed description:
Lucentis injections are the current standard of care for diabetic macular edema. The only deviation from the standard of care in the current protocol is an aqueous tap before the first Lucentis injection and the fourth Lucentis injection for diabetic macular edema.

Arms: arm 1: Aqueous Humor sample post injection of 0.3 mg Lucentis
Interventions: intervention 1: Lucentis
Intervention descriptions: intervention 1: 0.3mg Lucentis

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01489189
Conditions: Proliferative Diabetic Retinopathy
Sponsor: Jaeb Center for Health Research
Start date: 2012-03-01; Completion date: 2018-02-05
Enrollment: 305 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy.

Secondary objectives include:

* Comparing other visual function outcomes (including Humphrey visual field testing and study participant self-reports of visual function) in eyes receiving anti-VEGF with deferred PRP with those in eyes receiving prompt PRP.
* Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of prompt PRP.
* Comparing safety outcomes between treatment groups.
* Comparing associated treatment and follow-up exam costs between treatment groups.

Detailed description:

Arms: arm 1: Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated. arm 2: PRP= Panretinal Photocoagulation. PRP alone.
Interventions: intervention 1: Prompt Panretinal Photocoagulation intervention 2: 0.5-mg Ranibizumab intervention 3: Deferred panretinal photocoagulation
Intervention descriptions: intervention 1: Panretinal photocoagulation alone at baseline (full session completed within 56 days). intervention 2: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria. intervention 3: PRP is deferred until failure/futility criteria for intravitreal injection are met.

Protocol documents: