ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02390362
Conditions: Frequent Relapsing Nephrotic Syndrome Steroid Dependent Nephrotic Syndrome
Sponsor: Nationwide Children's Hospital
Start date: 2015-01-01; Completion date: 2017-01-18
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective than MMF in maintaining remission in children with frequent relapsing or steroid dependent nephrotic syndrome who have had one relapse while receiving MMF.

We will conduct a randomized study comparing two Rituximab infusions and continued MMF treatment. We plan to enroll 64 to have a comparater group of 58 (29 in each arm).

Detailed description:
After screening, and eligibility criteria have been met, children with steroid dependent and frequent relapsing nephrotic syndrome (SDNS and FRNS) will be enrolled into a 53 week study. The study is comprised of 3 sections; screening, treatment, and followup.

Screening will be \<4 weeks from Day 1/week 1. Treatment is Day 1/Week 1 and Day 15/Week 3. Follow-Up is Week 7, Week 13, Week 19, Week 27 and Week 53. Participants will be randomized by the study pharmacy between screening and treatment Day1. If participant is randomized to Rituximab, then Treatment Day 15 will be based on tolerance of Rituximab infusion.

Safety assessments will occur at every visit beginning with Day 1.

Arms: arm 1: Rituximab 375 mg/m2 will be administered intravenously on Study weeks 1 \& 3. arm 2: Mycophenolate Mofetil will be continued in the patients in the MMF arm at a standard oral dose of 600 mg/m2 PO, BID starting on Study week 1 and continuing for 12 months
Interventions: intervention 1: Rituximab intervention 2: MMF
Intervention descriptions: intervention 1: We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective in maintaining remission in children who have already had one relapse while receiving MMF intervention 2: Subjects randomized to MMF, will continue MMF as scheduled by the investigator

Protocol documents:
Clinical trial NCT02639247
Conditions: Hepatitis C Virus Infection
Keywords: Chronic
Sponsor: Gilead Sciences
Start date: 2015-12-23; Completion date: 2017-01-18
Enrollment: 333 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.

Detailed description:

Arms: arm 1: SOF/VEL/VOX for 12 weeks arm 2: SOF/VEL for 12 weeks
Interventions: intervention 1: SOF/VEL/VOX intervention 2: SOF/VEL
Intervention descriptions: intervention 1: 400/100/100 mg FDC tablet administered orally once daily with food intervention 2: 400/100 mg FDC tablet administered orally once daily without regard to food

Protocol documents:
Clinical trial NCT02217332
Conditions: Chronic Sinusitis With Nasal Polyps and Eosinophilia
Keywords: Sinusitis Rhinosinusitis CRS CRSwNP CSNP-E Nasal polyps Nasal polyposis Eosinophilia Asthma
Sponsor: Knopp Biosciences
Start date: 2014-08-01; Completion date: 2017-01-20
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase 2, open-label, multi-center study to evaluate the clinical effects of oral administration of dexpramipexole for 6 months in subjects with chronic sinusitis with nasal polyps and eosinophilia.

Detailed description:
This open-labelled study will evaluate the safety and preliminary efficacy of dexpramipexole for reducing the number of eosinophils in the peripheral blood and in improving nasal polyp score when administered to 20 subjects with chronic sinusitis with nasal polyps and eosinophilia.

Subjects will received dexpramipexole for up to 6 months and will have safety tests performed monthly and will have efficacy evaluations performed at month 1, month 3, and month 6 after beginning study drug.

Arms: arm 1: dexpramipexole 150 mg BID
Interventions: intervention 1: dexpramipexole
Intervention descriptions: intervention 1: Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)

Protocol documents:
Clinical trial NCT02279498
Conditions: Exocrine Pancreatic Insufficiency Cystic Fibrosis
Sponsor: Anthera Pharmaceuticals
Start date: 2015-06-01; Completion date: 2017-01-20
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase. The purpose of the present study is to provide additional efficacy and safety data compared to approved, porcine-derived, enterically-coated and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the study will be comparative efficacy measured as the change in the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).

Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of convenient formulations and with a number of foods without enteric coating.

Detailed description:
Porcine derived enzymes are used for pancreatic enzyme replacement therapy in patients with cystic fibrosis (CF). Liprotamase is a biotechnology-derived enzyme replacement without enteric coating. This is an open-label, assessor blind, parallel group, multicenter, international trial to evaluate the noninferiority of liprotamase and pancrelipase in CF patients aged ≥7 years with pancreatic insufficiency. Subjects were randomized to liprotamase or pancrelipase, dose-matched to pre-study lipase doses. The lower bound of the 95% confidence interval (CI) for noninferiority was -15% for treatment difference in change from baseline coefficient of fat absorption (CFA).

Arms: arm 1: Individually-optimized dose to be administered orally arm 2: Individually-optimized dose to be administered orally
Interventions: intervention 1: Liprotamase intervention 2: porcine (pig) PERT
Intervention descriptions: intervention 1: oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement intervention 2: oral, enterically-coated, pancreatic replacement enzymes prepared from a porcine source

Protocol documents:
Clinical trial NCT02449018
Conditions: Chronic Obstructive Pulmonary Disease, COPD
Keywords: COPD, chronic bronchitis, inflammation, airway, LCI, pulmonary function test, lung function, controlled clinical trial, randomized, airflow, smoker
Sponsor: Novartis Pharmaceuticals
Start date: 2015-04-30; Completion date: 2017-01-23
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo administered orally, on airway function, lung volume, and quality of life in patients with chronic obstructive pulmonary disease (COPD)

Detailed description:

Arms: arm 1: QBW251 will be provided to participants during 70 days arm 2: Placebo will be provided to participants during 70 days
Interventions: intervention 1: QBW251 intervention 2: Placebo
Intervention descriptions: intervention 1: QBW251 capsule(s) taken orally twice per day intervention 2: Matching placebo capsule(s) taken orally twice per day

Protocol documents:
Clinical trial NCT00950300
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-10-16; Completion date: 2017-01-24
Enrollment: 596 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this open-label multicenter trial, participants with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of chemotherapy (4 cycles of docetaxel followed by 4 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide) concurrent with either SC Herceptin or IV Herceptin. After surgery, participants will receive a further 10 cycles of SC or IV Herceptin as per randomization to complete 1 year of treatment. All cycles will be 21 days in length. After the end of study treatment, participants will be followed for safety and efficacy for up to 5 years or until disease recurrence, whichever is earlier.

Detailed description:

Arms: arm 1: Participants will receive Herceptin via IV infusion for 8 cycles prior to surgery and an additional 10 cycles after surgery. Docetaxel will be co-administered during Cycles 1 to 4; chemotherapy during Cycles 5 to 8 will include 5-fluorouracil, cyclophosphamide, and epirubicin. Herceptin IV will be given on Day 1 of each 21-day cycle, as 8 milligrams per kilogram (mg/kg) for a loading dose during Cycle 1 and as 6 mg/kg during subsequent cycles. arm 2: Participants will receive Herceptin via SC injection for 8 cycles prior to surgery and an additional 10 cycles after surgery. Docetaxel will be co-administered during Cycles 1 to 4; chemotherapy during Cycles 5 to 8 will include 5-fluorouracil, cyclophosphamide, and epirubicin. Herceptin SC will be given on Day 1 of each 21-day cycle, as a 600-milligram (mg) fixed dose.
Interventions: intervention 1: 5-Fluorouracil intervention 2: Cyclophosphamide intervention 3: Docetaxel intervention 4: Epirubicin intervention 5: Herceptin IV [trastuzumab] intervention 6: Herceptin SC [trastuzumab]
Intervention descriptions: intervention 1: Participants will receive 5-fluorouracil, 500 milligrams per meter-squared (mg/m\^2) via IV bolus or infusion, on Day 1 of every 21-day cycle during Cycles 5 to 8. intervention 2: Participants will receive cyclophosphamide, 500 mg/m\^2 via IV bolus, on Day 1 of every 21-day cycle during Cycles 5 to 8. intervention 3: Participants will receive docetaxel, 75 mg/m\^2 via IV infusion on Day 1 of every 21-day cycle during Cycles 1 to 4. intervention 4: Participants will receive epirubicin, 75 mg/m\^2 via IV bolus or infusion, on Day 1 of every 21-day cycle during Cycles 5 to 8. intervention 5: Herceptin will be administered as 8 mg/kg (loading dose during Cycle 1) and 6 mg/kg (subsequent cycles) via IV infusion on Day 1 of each 21-day cycle for a total of 18 cycles. intervention 6: Herceptin will be administered as fixed dose 600 mg SC on Day 1 of each 21-day cycle for a total of 18 cycles.

Protocol documents:
Clinical trial NCT02300233
Conditions: Hypertriglyceridemia
Sponsor: Ionis Pharmaceuticals, Inc.
Start date: 2015-02-05; Completion date: 2017-01-24
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with Hypertriglyceridemia.

Detailed description:

Arms: arm 1: Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks. arm 2: Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks. arm 3: Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
Interventions: intervention 1: Volanesorsen intervention 2: Placebo
Intervention descriptions: intervention 1: 300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks. intervention 2: Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.

Protocol documents:
Clinical trial NCT01212757
Conditions: Psoriatic Arthritis
Keywords: Psoriasis Arthritis Psoriatic Arthritis inflammation skin condition inflammatory cells apremilast CC-10004 phosphodiesterase type 4
Sponsor: Amgen
Start date: 2010-09-27; Completion date: 2017-01-25
Enrollment: 488 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis.

Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

Detailed description:
Psoriatic arthritis (PsA) is an inflammatory arthritis that occurs in 6-39% of psoriasis patients. The immunopathogenesis of PsA, which mirrors but is not identical to that seen in psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and endothelial cells, and inflammatory cells attracted to the synovium by cytokines and chemokines. Apremilast (CC-10004) is a novel oral agent that modulates multiple inflammatory pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition. Therefore, apremilast has the potential to be effective in the treatment of PsA.

Arms: arm 1: 20 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 20 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase arm 2: 30 mg Apremilast tablets administered twice a day for 24 weeks during the placebo-controlled phase followed by 30 mg Apremilast tablets administered twice a day for up to 4.5 years in the active treatment / long-term safety phase orally twice daily arm 3: Placebo + 20 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 20 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase. Subjects who do not have at least 20% improvement in their swollen and tender joint counts at Week 16 will escape to 20 mg Apremilast twice daily at Week 16 arm 4: Placebo + 30 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 30 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase. Subjects who do not have at least 20% improvement in their swollen and tender joint counts at Week 16 will escape to 30 mg Apremilast twice daily at Week 16.
Interventions: intervention 1: Apremilast 20mg intervention 2: Apremilast 30mg intervention 3: Placebo + 20 mg Apremilast intervention 4: Placebo + 30 mg Apremilast
Intervention descriptions: intervention 1: Apremilast 20 mg twice daily, orally intervention 2: Apremilast 30 mg twice daily, orally intervention 3: Placebo + 20 mg Apremilast intervention 4: Placebo + 30 mg Apremilast

Protocol documents:
Clinical trial NCT02148588
Conditions: Central Post Stroke Pain
Keywords: Central Post Stroke Pain Nerve block
Sponsor: Washington University School of Medicine
Start date: 2014-08-01; Completion date: 2017-01-25
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Prospective, open-label study in 10 patients with Central Post Stroke Pain (CPSP). The study will evaluate the effects of peripheral nerve blockade on spontaneous pain and evoked thermal and mechanical responses in CPSP, and assesses the associated local anesthetic pharmacokinetics.

Detailed description:

Arms: arm 1: Completion of NPSI questionnaire

Sensory mapping of the affected limb

Quantitative Sensory Testing

Patients will have a peripheral nerve blockade
Interventions: intervention 1: Ultrasound-guided peripheral nerve block with 2% lidocaine
Intervention descriptions: intervention 1: Patients will have a peripheral nerve blockade with a local anesthetic (lidocaine)

Assessment of spontaneous and evoked pain responses

Completion of NPSI questionnaire

Mapping of the affected limb

Protocol documents:
Clinical trial NCT02434146
Conditions: Neoplasm Oral Mucosa Transplant-Related Disorder
Sponsor: University of Wisconsin, Madison
Start date: 2015-05-14; Completion date: 2017-01-25
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial studies the safety of topical phenylephrine solution and to see how well it works in preventing oral mucosa (mouth sores) in bone marrow transplant patients receiving cyclophosphamide and total body radiation therapy. Topical phenylephrine solution may prevent or lessen the severity of oral mucosa in patients receiving cyclophosphamide and total body radiation prior to undergoing a bone marrow transplant.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the safety and tolerability of phenylephrine (topical phenylephrine solution) applied topically to the oral mucosa of bone marrow transplant patients treated with cyclophosphamide plus total body irradiation.

II. To determine the maximum tolerated dose (MTD) and recommended phase II dose of phenylephrine applied topically to the oral mucosa of bone marrow transplant patients treated with cyclophosphamide plus total body irradiation.

III. To evaluate the efficacy of phenylephrine applied topically to the oral mucosa in preventing and/or decreasing severity of oral mucositis in bone marrow transplant patients treated with cyclophosphamide plus total body irradiation.

OUTLINE: This is a phase I, dose-escalation study of topical phenylephrine solution followed by a phase II study.

Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.

After completion of study treatment, patients are followed up weekly for 2 weeks and then at 3 months.

Arms: arm 1: Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.
Interventions: intervention 1: Topical Phenylephrine Solution
Intervention descriptions: intervention 1: Given topically via spray

Protocol documents:
Clinical trial NCT02254772
Conditions: Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Small Lymphocytic Lymphoma Splenic Marginal Zone Lymphoma
Sponsor: Robert Lowsky
Start date: 2014-09-01; Completion date: 2017-01-26
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase 1-2 trial studies the side effects and best dose of ipilimumab in combination with toll-like receptor 9 (TLR9) agonist SD-101 and radiation therapy in treating patients with recurrent low-grade B-cell lymphoma.

Detailed description:
Monoclonal antibodies, such as ipilimumab, may block cancer growth in different ways by targeting certain cells. Biological therapies, such as TLR9 agonist SD-101, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving ipilimumab in combination with TLR9 agonist SD-101 and radiation therapy may be a better treatment for B-cell lymphoma.

Study objectives are dose-limiting toxicity (DLT) and the treatment assessments tumor response and time-to-progression. Cohort 1 dose level is 10 mg ipilimumab, subsequent cohort is 5 or 25 mg ipilimumab.

* If 2 out of 6 patients experience a DLT in the first cohort (10 mg ipilimumab), the dose will be de-escalated to 5 mg ("Cohort -1").
* If 2 out of 6 patients experience a DLT at the 5 mg dose level, then the study will be stopped.

Arms: arm 1: Patients receive TLR9 agonist SD-101 via intratumoral injections; ipilimumab via intratumoral injection; and undergo radiation therapy on days 1 and 2.
Interventions: intervention 1: Ipilimumab intervention 2: SD-101 intervention 3: Radiation therapy
Intervention descriptions: intervention 1: A dose of 10 mg in cohort 1 or 25mg in cohort 2 via intratumoral injection on day 2, week 1. intervention 2: Started on day 2 week 1, then once every week x 4 successive weeks for a total of 5 injections. intervention 3: Undergo low-dose radiation therapy to 1 site of disease

Protocol documents:
Clinical trial NCT02491463
Conditions: Respiratory Synctial Virus Infections
Keywords: Reactogenicity Safety Respiratory syncytial virus (RSV) Vaccine Immunogenicity
Sponsor: GlaxoSmithKline
Start date: 2015-07-23; Completion date: 2017-01-26
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this first time in human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of 2 doses of the RSV investigational vaccine, when administered intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years.

Detailed description:

Arms: arm 1: Subjects in this group will receive 2 doses, one month apart of the GSK3389245A vaccine low dose arm 2: Subjects in this group will receive 2 doses, one month apart, of the GSK3389245A vaccine high dose arm 3: Subjects in this group will receive 2 doses, one month apart, of Bexsero arm 4: Subjects in this group will receive 2 doses, one month apart, of placebo
Interventions: intervention 1: GSK3389245A_LD GROUP intervention 2: GSK3389245A_HD GROUP intervention 3: Bexsero intervention 4: Placebo
Intervention descriptions: intervention 1: 2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm intervention 2: 2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm intervention 3: 2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm intervention 4: 2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

Protocol documents: