ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01140568
Conditions: Glioma
Keywords: glioma PDGFR kinase inhibitor malignant nilotinib
Sponsor: David Piccioni, M.D., Ph.D
Start date: 2010-04-21; Completion date: 2019-01-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the survival, disease response, and side effects of Tasigna® (nilotinib) in patients who have malignant gliomas and are positive for Platelet Derived Growth Factor Receptor (PDGFR) amplification. This study is designed to test the hypothesis that patients with malignant gliomas with PDGFR amplification are sensitive to PDGFR kinase inhibitors.

Detailed description:
Malignant gliomas (MG), including anaplastic gliomas (AG) and glioblastoma (GBM), are the most common primary brain tumor. Standard of care (surgery, radiotherapy, and temozolomide at initial diagnosis) results in a median survival of only 14 months. For patients with recurrent disease, conventional chemotherapy is generally ineffective with response rates \<20%. Clearly there is need for improved treatments. Recent genome-wide studies have confirmed that GBM is a heterogeneous group of diseases that can be subclassified by shared genetic aberrations. The implication is that, in part, the underlying genetics may determine responsiveness to treatments and thus allow us to personalize therapy.

This is an, open-label, non-randomized, phase II study with oral nilotinib in adult patients with biomarker-enriched, recurrent malignant gliomas who have developed tumor progression after standard therapy. Patients will be treated with oral nilotinib (starting with the labeled dose of 400 mg) daily until disease progression or intolerance. One cycle is defined as 28 days.

Approximately 50 evaluable patients will be enrolled in this study, with 32 (grade IV) and 18 (grade III) in separate arms.

All patients will undergo clinical evaluation after each 28-day cycle. Neuroimaging studies (MRI) will be performed at baseline, 4 weeks, 8 weeks and then after every 2 cycles (8 weeks). If a contraindication for MRI's exists, patients will undergo contrast-enhanced CT scans. Laboratory tests will be obtained weekly during the first 4 weeks, and then on days 1 and 15 of all subsequent cycles. Patients will remain on study medication unless they develop tumor progression or unacceptable toxicity.

Arms: arm 1: Patients will take nilotinib twice daily at the standard dose of 400mg taken by mouth twice a day until disease progression or development of unacceptable side effects.
Interventions: intervention 1: nilotinib
Intervention descriptions: intervention 1: 400mg po (orally) BID (twice daily)

Protocol documents:
Clinical trial NCT01941537
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Sponsor: Rockefeller University
Start date: 2013-10-01; Completion date: 2019-01-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Atopic dermatitis (AD) is a common inflammatory skin disorder that adversely affects most aspects of everyday life in majority of patients. It has a prevalence of up to 3-4% of adults and up to 25% among children. AD has a complex pathogenesis, characterized by: 1) immune activation with increased numbers of T-cells, dendritic cells (DCs), and increased expression of inflammatory molecules 2) marked epidermal hyperplasia in chronic diseased skin, and 3) defective barrier function with increased trans-epidermal water loss (TEWL) and decreased lipids, reflecting underlying alterations in keratinocyte differentiation. AD is predominantly a Th2 (IL-4, IL-13, and IL-31) disease, and recently was also found to be a "T22" (IL-22) polarized disease.

ILV-094 is an anti IL-22 antibody and therefore should reverse the immune activation of AD. This study is being done to assess the safety, tolerability, clinical efficacy, and mechanism of action of ILV-094 in patients with AD.

Detailed description:
This is a randomized, double-blind, placebo-controlled, study of six IV infusions of ILV-094 administered to subjects with atopic dermatitis. Sixty subjects will be randomly assigned in a 2:1 ratio to one of the two treatments arms (ILV-094 vs placebo). Forty patients will be enrolled in the ILV-094 treatment arm and 20 in the placebo-treatment arm, accordingly. A loading IV dose of 600 mg of ILV-094 or placebo will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 or placebo every two weeks (Weeks 2, 4, 6, 8, and 10). We will continue to follow the patients every two weeks for an additional 10 weeks after the last IV dose (20 weeks post baseline).

Arms: arm 1: Forty patients will be enrolled in the ILV-094 treatment arm. A loading IV dose of 600 mg of ILV-094 will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 every two weeks (Weeks 2, 4, 6, 8, and 10). arm 2: Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).
Interventions: intervention 1: ILV-094 intervention 2: Placebo Comparator
Intervention descriptions: intervention 1: IV infusion of ILV-094 intervention 2: Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).

Protocol documents:
Clinical trial NCT02016235
Conditions: Dent Disease
Keywords: Dent Dents Dent Disease Phosphorus Supplements FGF 23
Sponsor: Mayo Clinic
Start date: 2014-09-01; Completion date: 2019-01-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Patients with Dent disease have suppressed levels of FGF 23 which contributes to hypercalciuria, kidney stones, nephrocalcinosis and renal failure. Supplementation with phosphorus may reduce hypercalciuria.

Detailed description:

Arms: arm 1: Dent Disease subjects will receive 2 week supplementation with phosphorus arm 2: Kidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus arm 3: Dent disease subjects will not get phosphorus
Interventions: intervention 1: Phosphorus Supplement intervention 2: Observation
Intervention descriptions: intervention 1: 250 mg po qid intervention 2: Baseline blood and urine measurements only

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT02218190
Conditions: Ileus Spinal Fusion
Keywords: Alvimopan Ileus Posterior spinal fusion
Sponsor: Washington University School of Medicine
Start date: 2014-08-01; Completion date: 2019-01-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine with Alvimopan reduces the incidence of post operative ileus in patients who undergo posterior spinal fusion.

Detailed description:
Posterior spinal fusion (PSF) is a common orthopaedic procedure associated with a high incidence of post-operative ileus (POI) and concomitant increased length of hospital stay (LOHS). POI is exacerbated by high dose opiate consumption often required by these patients post-operatively. We propose a randomized, double-blinded, placebo-controlled pilot trial studying the use of alvimopan, a peripherally-acting mu-opioid receptor antagonist known to reduce POI in bowel resection. We hypothesize that alvimopan will shorten POI in spine fusion patients without negatively affecting post-operative pain control. Treatment efficacy will be assessed by recording time to first bowel movement, time to hospital discharge, and post-operative pain control.

We hypothesize that acute administration of alvimopan, a peripherally-acting mu-opioid antagonist, shortens the duration of post-operative ileus (POI) in patients undergoing long-segment (5 or greater thoracolumbar levels) posterior spinal fusion (PSF). The study will be a randomized, double-blinded, placebo-controlled pilot trial. Reducing the morbidity of POI in patients undergoing PSF will decrease hospital stay and costs, and also improve patient satisfaction and post-operative care after major orthopaedic surgery.

Arms: arm 1: Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven. arm 2: Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven
Interventions: intervention 1: Alvimopan intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02345226
Conditions: HIV-1 Infection
Keywords: HIV
Sponsor: Gilead Sciences
Start date: 2015-01-26; Completion date: 2019-01-02
Enrollment: 881 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in virologically-suppressed HIV-1 infected participants.

Detailed description:

Arms: arm 1: FTC/RPV/TAF plus EFV/FTC/TDF placebo for at least 96 weeks. arm 2: EFV/FTC/TDF plus FTC/RPV/TAF placebo for at least 96 weeks. arm 3: After the Week 96 visit, participants will be given the option to receive open label FTC/RPV/TAF for up to an additional 48 weeks. In countries where FTC/RPV/TAF is not yet commercially available, participants will be given the option to receive open-label FTC/RPV/TAF and attend visits every 12 weeks until FTC/RPV/TAF becomes commercially available, or until Gilead elects to discontinue the study, whichever occurs first.
Interventions: intervention 1: FTC/RPV/TAF intervention 2: EFV/FTC/TDF Placebo intervention 3: EFV/FTC/TDF intervention 4: FTC/RPV/TAF Placebo
Intervention descriptions: intervention 1: 200/25/25 mg FDC tablets administered orally once daily intervention 2: Tablets administered orally once daily intervention 3: 600/200/300 mg FDC tablets administered orally once daily intervention 4: Tablets administered orally once daily

Protocol documents:
Clinical trial NCT03457636
Conditions: Acne
Sponsor: Derm Research, PLLC
Start date: 2018-03-19; Completion date: 2019-01-04
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-center, open label pilot study. The study is comprised of 5 study visits; Screening, Baseline, and weeks 4, 8, and 12. All subjects will receive Oracea once daily (QD) and Epiduo Forte at Baseline. We will evaluate Investigator Global Assessment (IGA), total lesion count, inflammatory lesion count, non-inflammatory lesion count, adverse events and concomitant medications.

Detailed description:
This is a single-center, open label pilot study. The study is comprised of 5 study visits; Screening, Baseline, and weeks 4,8, and 12. All subjects will receive Oracea once daily (QD) and Epiduo Forte at Baseline. WE will evaluate Investigator Global Assessment (IGA), total lesion count, adverse events and concomitant medications.

Arms: arm 1: All subjects will receive at Baseline doxycycline anhydrous 40 mg (Oracea) to be taken once daily and Adapalene-Benzoyl Peroxide Gel .3-2.5% (Epiduo) to be applied once daily for 12 weeks
Interventions: intervention 1: Doxycycline Anhydrous 40 MG intervention 2: Adapalene/Benzoyl Peroxide Gel 0.3-2.5%
Intervention descriptions: intervention 1: One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals intervention 2: Epiduo Forte should be applied in a thin layer to affected areas of the face and/or trunk once daily after washing, with care taken to avoid the eyes, lips, and mucous membranes

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01207388
Conditions: B-cell Acute Lymphoblastic Leukemia
Keywords: Blinatumomab MRD B-ALL Minimal residual disease adult ALL Leukemia ALL Lymphatic diseases Lymphoproliferative disorders bispecific antibody anti-CD19 Immunotherapeutic treatment
Sponsor: Amgen Research (Munich) GmbH
Start date: 2010-11-01; Completion date: 2019-01-07
Enrollment: 116 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.

Detailed description:
The detection of minimal residual disease (MRD) after induction therapy and/or consolidation therapy is an independent prognostic factor for poor outcome of adult ALL. No standard treatments are available for patients with MRD-positive B-precursor ALL. Blinatumomab (MT103) is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T-cell activation and a cytotoxic T-cell response against cluster of differentiation (CD)19 expressing cells. The purpose of this study is to confirm whether the bispecific T-cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.

Participants will receive up to four 4-week cycles of intravenous blinatumomab treatment followed by an infusion-free period of 14 days. A safety follow-up will be performed 30 days after the end of the last infusion and efficacy follow-ups will occur until 24 months after treatment start. Participants will be followed for up to 5 years after the start of treatment for survival.

Arms: arm 1: Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
Interventions: intervention 1: Blinatumomab
Intervention descriptions: intervention 1: Continuous intravenous infusion

Protocol documents:
Clinical trial NCT01984242
Conditions: Renal Cell Carcinoma
Sponsor: Hoffmann-La Roche
Start date: 2014-01-08; Completion date: 2019-01-08
Enrollment: 305 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multicenter, randomized, open-label study will evaluate the efficacy, safety and tolerability of atezolizumab as monotherapy or in combination with bevacizumab versus sunitinib in participants with histologically confirmed, inoperable, locally advanced or metastatic renal cell carcinoma who have not received prior systemic therapy either in the adjuvant or metastatic setting.

Detailed description:

Arms: arm 1: Atezolizumab 1200 milligrams (mg) and bevacizumab 15 milligrams per kilogram (mg/kg) will be administered as intravenous (IV) infusions every 3 weeks (q3w) on Day 1 and Day 22 of each 6-week cycle until disease progression. arm 2: Atezolizumab 1200 mg will be administered as IV infusion q3w on Day 1 and Day 22 of each 6-week cycle until disease progression. Upon disease progression, participants (except European Union \[EU\] participants) can crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination. arm 3: Sunitinib 50 mg will be administered orally once daily on Days 1 to 28 of each 6-week cycle until disease progression. Upon disease progression, participants can crossover to receive atezolizumab and bevacizumab combination until disease progression, lack of clinical benefit, unacceptable toxicity, withdrawal from study, or study completion or termination.
Interventions: intervention 1: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody intervention 2: Bevacizumab intervention 3: Sunitinib
Intervention descriptions: intervention 1: Atezolizumab will be administered according to the dosage schedule mentioned in the arm description. intervention 2: Bevacizumab will be administered according to the dosage schedule mentioned in the arm description. intervention 3: Sunitinib will be administered according to the dosage schedule mentioned in the arm description.

Protocol documents:
Clinical trial NCT04481789
Conditions: Healthy Adult Subjects
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2018-10-17; Completion date: 2019-01-08
Enrollment: 84 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
* Cohort 1: To evaluate the drug interactions, safety, and tolerability of oral edaravone when coadministered with rosuvastatin, sildenafil or furosemide in healthy adult males
* Cohort 2: To evaluate the pharmacokinetics, safety, and tolerability of oral edaravone in healthy Japanese and Caucasian adult males

Detailed description:

Arms: arm 1: Group 1 of Cohort 1:

A single-sequence study in which healthy male subjects receive a single dose of rosuvastatin on Day 1 followed by a single dose of sildenafil on Day 4. MT-1186 will be administered from Day 6 to 13 with co-administration of rosuvastatin and sildenafil on Day 9 and 12, respectively. arm 2: Group 2 of Cohort 1:

A single-sequence study in which healthy male subjects receive a single dose of furosemide on Day 1. MT-1186 will be administered from Day 3 to 7 with co-administration of furosemide on Day 6. arm 3: Cohort 2:

A three-way crossover study in which Japanese healthy male subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 4, and 7 according to their treatment sequence with 3-day wash out between doses. Caucasian healthy male subjects receive a single dose of MT-1186 at the same period with Japanese subjects under the corresponding condition on Day 1, 4, or 7 according to their treatment schedule.
Interventions: intervention 1: MT-1186 intervention 2: Rosuvastatin intervention 3: Sildenafil intervention 4: Furosemide
Intervention descriptions: intervention 1: Suspension intervention 2: Tablets intervention 3: Tablets intervention 4: Tablets

Protocol documents:
Prot_000.pdf: 





















































































































































































































SAP_001.pdf:
Clinical trial NCT02008227
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2014-03-11; Completion date: 2019-01-09
Enrollment: 1225 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 \[anti-PD-L1\] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Detailed description:

Arms: arm 1: Atezolizumab 1200 milligrams (mg) was administered via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first. arm 2: Docetaxel 75 milligrams per meter square (mg/m\^2) was administered via IV infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.
Interventions: intervention 1: Atezolizumab intervention 2: Docetaxel
Intervention descriptions: intervention 1: 1200 mg IV infusion on Day 1 of each 21-day cycle intervention 2: 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle

Protocol documents:
Clinical trial NCT02345252
Conditions: HIV-1 Infection
Keywords: HIV
Sponsor: Gilead Sciences
Start date: 2015-01-26; Completion date: 2019-01-09
Enrollment: 632 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in virologically suppressed HIV-1 infected participants.

Detailed description:

Arms: arm 1: FTC/RPV/TAF plus FTC/RPV/TDF placebo for at least 96 weeks. arm 2: FTC/RPV/TDF plus FTC/RPV/TAF placebo for at least 96 weeks. arm 3: After the Week 96 visit is completed, participants will be given the option to receive open label FTC/RPV/TAF for up to an additional 48 weeks. In countries where FTC/RPV/TAF is not yet commercially available, participants will be given the option to receive open-label FTC/RPV/TAF, and attend visits every 12 weeks until FTC/RPV/TAF becomes commercially available, or until Gilead Sciences elects to discontinue the study, whichever occurs first.
Interventions: intervention 1: FTC/RPV/TAF intervention 2: FTC/RPV/TDF Placebo intervention 3: FTC/RPV/TDF intervention 4: FTC/RPV/TAF Placebo
Intervention descriptions: intervention 1: 200/25/25 mg FDC tablets administered orally once daily intervention 2: Tablets administered orally once daily intervention 3: 200/25/300 mg FDC tablets administered orally once daily intervention 4: Tablets administered orally once daily

Protocol documents: