ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02097238
Conditions: Recurrent Osteosarcoma
Sponsor: National Cancer Institute (NCI)
Start date: 2014-08-01; Completion date: 2020-03-31
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well eribulin mesylate works in treating patients with osteosarcoma that has come back after treatment (recurrent) or has not responded to treatment (refractory). Microtubule inhibitors, such as eribulin mesylate, may stop or slow the growth of tumor cells by disrupting the cell cycle.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the 4 month progression free survival rate and objective response rate in patients with recurrent osteosarcoma who are administered eribulin (eribulin mesylate) therapy on day 1 and day 8 of 21 day cycles.

SECONDARY OBJECTIVES:

I. To investigate the pharmacokinetics (PK) of eribulin in subjects with recurrent osteosarcoma.

II. To further describe the tolerability of single agent eribulin.

OUTLINE:

Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

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

Arms: arm 1: Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Eribulin Mesylate intervention 2: Pharmacological Study
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01815736
Conditions: HIV HIV Infections
Keywords: HIV HIV 1 Infected Virologically-Suppressed
Sponsor: Gilead Sciences
Start date: 2013-03-27; Completion date: 2020-04-01
Enrollment: 1443 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA \< 50 copies/mL at Week 48.

Detailed description:

Arms: arm 1: Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) for up to 96 weeks.

Extension Phase: After completing 96 weeks of randomized treatment, all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF. arm 2: Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks.

Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF.
Interventions: intervention 1: E/C/F/TAF intervention 2: E/C/F/TDF intervention 3: EFV/FTC/TDF intervention 4: RTV intervention 5: ATV intervention 6: FTC/TDF intervention 7: COBI
Intervention descriptions: intervention 1: 150/150/200/10 mg FDC tablet administered orally once daily intervention 2: 150/150/200/300 mg FDC tablet administered orally once daily intervention 3: 600/200/300 mg FDC tablet administered orally once daily intervention 4: 100 mg tablet administered orally once daily intervention 5: 300 mg capsule administered orally once daily intervention 6: 200/300 mg tablet administered orally once daily intervention 7: 150 mg tablet administered orally once daily

Protocol documents:
Clinical trial NCT02459119
Conditions: Urothelial Cancer (Urinary Bladder, Ureters, or Renal Pelvis Cancer)
Keywords: urothelial cancer Regorafenib
Sponsor: University of Alabama at Birmingham
Start date: 2015-05-01; Completion date: 2020-04-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will test how well Regorafenib controls disease progression in urothelial cancer (cancer occurring in the urinary bladder, ureters, or renal pelvis) following previous therapy with chemotherapy.

Detailed description:
Advanced urothelial carcinoma (UC) has a poor long-term prognosis. The disease has not seen improved outcomes despite research efforts in over two decades. Novel therapeutic options are needed. Regorafenib is a novel oral multikinase inhibitor but is more potent than a similar multikinase inhibitor drug that treats advanced renal cell carcinoma and hepatocellular carcinoma. Regorafenib has been shown to have a broader capacity to inhibit blood supply to tumor sources.

This trial evaluates a proof-of-concept using Regorafenib in patients with metastatic progressive urothelial carcinoma following chemotherapy but still have a high level of activity performance in their daily living. The initial dose of Regorafenib will be 120 mg daily and then be escalated to 160 mg daily before gradually tapering.

Arms: arm 1: Regorafenib will be administered orally to all patients on study. The drug will be taken once a day for 3 of every 4 week cycle (3 weeks on/1 week off). The dose is 120 mg once daily for the first cycle, then 160 mg once daily from the second cycle if no significant Regorafenib-associated toxicities occur during the first cycle. Drug dosage may be modified if toxicities occur. Patients will undergo up to 4 cycles of treatment and may continue on additional at the discretion of the investigator.
Interventions: intervention 1: Regorafenib
Intervention descriptions: intervention 1: Regorafenib will be packaged as 40 mg tablets in a bottle. Patients will be instructed to maintain a daily medication calendar.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT02541903
Conditions: Penile Squamous Cell Carcinoma (PSCC)
Keywords: Epidermal growth factor receptor (EGFR), Human Papillomavirus (HPV) Penile squamous cell carcinoma (PSCC) Gilotrif
Sponsor: University of Alabama at Birmingham
Start date: 2015-10-01; Completion date: 2020-04-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease. Supportive evidence for the value of systemic therapy does not exist for this disease and there are no agents currently approved by regulatory agencies. This study will evaluate the drug Gilotrif in patients with metastatic progressive PSCC following chemotherapy. Gilotrif has shown supportive evidence in non-small cell lung cancer by inhibiting certain proteins that are also found in PSCC. The drug has the potential for some patients to exhibit a response contributing to a greater quality of life.

Detailed description:
This is a non-randomized trial phase 2 trial in which the drug Gilotrif will be administered at an oral dosage of 40 mg daily. This will continue until there is disease progression or severe toxicities. Patients will undergo a clinical exam every 4 weeks as well as have blood collected. Radiographic scans will be done every 8 weeks.

Arms: arm 1: Gilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks).
Interventions: intervention 1: Gilotrif
Intervention descriptions: intervention 1: Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur.

Protocol documents:
Prot_SAP_ICF_000.pdf:
Clinical trial NCT03175549
Conditions: Alcohol Use Disorder
Sponsor: The Scripps Research Institute
Start date: 2017-11-01; Completion date: 2020-04-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary hypotheses under test are that alcohol dependent subjects treated with apremilast will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.

Detailed description:

Arms: arm 1: Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days. arm 2: Identical placebo pills taken orally for 14 days
Interventions: intervention 1: Apremilast intervention 2: Placebo
Intervention descriptions: intervention 1: Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days. intervention 2: Identical placebo pills taken orally for 14 days

Protocol documents:
Prot_002.pdf: 















































































SAP_003.pdf: 



ICF_004.pdf:
Clinical trial NCT03938337
Conditions: Head and Neck Cancer
Keywords: immunotherapy abemaciclib pembrolizumab Cyclin-Dependent Kinase (CDK): CDK4 Cyclin-Dependent Kinase (CDK): CDK6
Sponsor: University of Alabama at Birmingham
Start date: 2019-10-08; Completion date: 2020-04-03
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the objective response rate of tumor lesions to abemaciclib in combination with pembrolizumab in patients with metastatic or recurrent squamous cell carcinoma of head and neck.

Detailed description:
Immunotherapy has been recently approved for patients with metastatic or recurrent squamous cell carcinoma of the head and neck. However, only a small percentage of patients experience long-term control, necessitating new therapeutic strategies. Recently, it was shown preclinically and in breast tumors that abemaciclib stimulates production of type III interferons and hence enhances tumor antigen presentation. Abemaciclib also suppressed the proliferation of regulatory T cells. These events promote cytotoxic T-cell-mediated clearance of tumor cells, which is further enhanced by the addition of immune checkpoint blockade. Based on these data, a phase II trial in patients with metastatic or recurrent head and neck cancer who are eligible for immunotherapy is proposed to investigate the combination of abemaciclib with pembrolizumab. Tumor \& blood analysis for interferon gamma signature will be explored as possible biomarkers.

Arms: arm 1: Patients with metastatic or recurrent head and neck cancer who have not been treated previously with immunotherapy. arm 2: Patients with metastatic or recurrent head and neck cancer who have been treated previously with immunotherapy.
Interventions: intervention 1: Cohort 1 Not Previously Treated intervention 2: Cohort 2 Treated Previously
Intervention descriptions: intervention 1: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks intervention 2: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT03375294
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
Sponsor: Stanford University
Start date: 2018-04-01; Completion date: 2020-04-05
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to understand nitrous oxide effects in post traumatic stress disorder (PTSD)

Detailed description:
Post traumatic stress disorder (PTSD) is a disabling mental health disorder that impacts the lives of individuals. This study aims to understand nitrous oxide's effects in PTSD.

Arms: arm 1: PTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour
Interventions: intervention 1: Nitrous Oxide
Intervention descriptions: intervention 1: One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation

Protocol documents:
Prot_SAP_000.pdf: 
June 26, 2020  
Protocol Title: Exploring Nitrous Oxide Effects for Posttraumatic Stress Disorder (PTSD) 
NCT03375294 
 
Study Protocol/Method  
Three veteran outpatients (ages 31, 43, and 46 years) who met PTSD criteria of at least moderate 
symptom severity (Clinician-Administered PTSD Scale for DSM-5 [CAPS-5] score ≥ 40) were recruited 
from the Veterans Affairs Palo Alto Health Care System between April 2018 and July 2019. Individuals 
were excluded if they had comorbid psychiatric or medical conditions that increased the risk of 
participation. All participants completed a single 1-hour subanesthetic inhalation of 50% nitrous oxide 
and 50% oxygen administered by an anesthesiologist via face mask and standard semi-closed anesthetic 
circuit with a total gas flow rate of 4–8 L/min. A trained independent evaluator rated PTSD symptoms 
using CAPS-5 at baseline and 1 week after drug administration.  
Statistical Analysis Plan  
Response was defined a priori as a CAPS-5 score reduction of 12 points at 7 days.
Clinical trial NCT02130557
Conditions: Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive
Keywords: Leukemia Myelogenous Chronic BCR-ABL Positive Bosutinib Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome Neoplasms by Histologic Type Bone Marrow Diseases Hematologic Diseases Translocation, Genetic Pathologic Processes Imatinib Therapeutic Uses Pharmacologic Actions Molecular Mechanisms of Pharmacological Action
Sponsor: Pfizer
Start date: 2014-07-15; Completion date: 2020-04-17
Enrollment: 536 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.

Detailed description:
The study will be open for enrollment until the planned number of approximately 500 Philadelphia Chromosome Positive (Ph+) patients have been randomized (approximately 250 Ph+ patients in each treatment arm; a total of approximately 530 Ph+ and Ph- patients). All patients will be treated and/or followed for approximately 5 years (240 weeks) after randomization until the study has closed. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 5 years (240 weeks) after randomization.

Arms: arm 1: Bosutinib, 400 mg, oral administration once a day arm 2: Imatinib, 400 mg, oral administration once a day
Interventions: intervention 1: Bosutinib intervention 2: Imatinib
Intervention descriptions: intervention 1: Bosutinib (Bosulif®) is an orally bioavailable, potent, multi-targeted, dual Src-Abl tyrosine kinase inhibitor (TKI) that has been approved for the treatment of adult patients with Philadelphia positive (Ph+) chronic phase (CP), accelerated phase (AP) and blast phase (BP) chronic myelogenous leukemia (CML) previously treated with other TKI inhibitor therapy.\[1\] This study will investigate the use of bosutinib as first-line treatment for patients with Ph+ CP CML. intervention 2: Imatinib mesylate (referred to in this protocol as imatinib) is an inhibitor of the BCR-ABL kinase and been the standard first-line therapy for patients with chronic-phase CML. Imatinib was granted approval by the European Commission in November 2001 and by the FDA in December 2002 for the treatment of newly diagnosed patients with CP Ph+ CML based on results from the IRIS trial.

Imatinib is considered the standard of care for both first-line and later line settings, and consequently is an appropriate active comparator.

Protocol documents:
Clinical trial NCT01849250
Conditions: Benign Breast Neoplasm Ductal Breast Carcinoma In Situ Invasive Breast Carcinoma Lobular Breast Carcinoma In Situ Paget Disease of the Breast Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2013-05-01; Completion date: 2020-04-22
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies how well docosahexaenoic acid works in preventing recurrence in breast cancer survivors. Docosahexaenoic acid supplement may prevent recurrence in breast cancer survivors.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine whether treatment with docosahexaenoic acid (DHA) for 12 weeks at 1000 mg twice daily as compared to placebo reduces normal breast tissue levels of tumor necrosis factor-alpha (TNF-alpha) in overweight and obese patients with a history of stage I-III invasive breast cancer, ductal carcinoma in situ (DCIS), Paget's disease, lobular carcinoma in situ (LCIS), or proliferative benign breast disease.

SECONDARY OBJECTIVES:

I. To investigate the effect of DHA at 1000 mg twice daily on tissue biomarkers

* Change from the baseline in cyclooxygenase-2 (COX-2)/interleukin-1-beta (IL-1beta)/aromatase measured by quantitative real-time polymerase chain reaction (PCR).
* Change from the baseline in crown-like structures of the breast (CLS-B) measured by immunohistochemical techniques for cluster of differentiation (CD)68.
* Change from baseline in CLS-B index determined as follows: (\[number of slides with evidence of at least one CLS-B\]/\[total number of slides examined\]).
* Change from baseline in CLS-B/cm\^2 defined as the number of CLS-B/cm\^2. II. Evaluate age as a predictor of CLS-B and inflammatory biomarkers (TNF-alpha/COX-2/IL-1beta) at baseline and over the time of treatment.

III. Evaluate red blood cell (RBC) fatty acid level as a surrogate of compliance.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive docosahexaenoic acid orally (PO) twice daily (BID) for 12 weeks.

ARM II: Patients receive placebo PO BID for 12 weeks.

Arms: arm 1: Docosahexaenoic Acid orally twice a day (PO BID) for 12 weeks. arm 2: Placebo orally twice a day (PO BID) for 12 weeks.
Interventions: intervention 1: Docosahexaenoic Acid intervention 2: Placebo
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO

Protocol documents:
Clinical trial NCT04254913
Conditions: Japanese Patients With ALS
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2020-01-24; Completion date: 2020-04-22
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Amyotrophic Lateral Sclerosis Patients with gastrostomy

Detailed description:

Arms: arm 1: Patients receive the edaravone oral suspension.
Interventions: intervention 1: MT-1186
Intervention descriptions: intervention 1: Suspension

Protocol documents:
Prot_000.pdf: 



















































































































SAP_001.pdf:
Clinical trial NCT03869684
Conditions: Age-related Macular Degeneration
Keywords: Exudative Wet AMD Age-related macular degeneration Age related macular degeneration
Sponsor: Senju Pharmaceutical Co., Ltd.
Start date: 2019-02-25; Completion date: 2020-04-24
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Age-related macular degeneration (AMD) is the leading cause of blindness among adults in North America. The current standard of care for patients with exudative ("wet") AMD is anti-vascular endothelial growth factor (anti-VEGF) therapy which must be administered by an injection into the eye every 4-8 weeks. MT-0814 is being developed for the treatment of patients with exudative AMD, and could offer an alternative, safer and less burdensome therapy.

Detailed description:

Arms: arm 1: None arm 2: MT-0814 plus placebo arm 3: None
Interventions: intervention 1: MT-0814 intervention 2: Placebo
Intervention descriptions: intervention 1: Randomly assigned dose intervention 2: Placebo manufactured to mimic MT-0814

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
NCT Number: NCT03869684 
 
 
Protocol Number: MT-0814/2-01 
 
 
Study Title: 
A Double-Masked, Randomized, Multicenter, Placebo-Controlled, Parallel-
Group Study to Assess the Safety, Tolerability, and Efficacy of MT-0814 for the 
Treatment of Patients with Age-Related Macular Degeneration 
 
 
Protocol Version: Version 4.0: 29 November 2019
Clinical trial NCT01100502
Conditions: Disease, Hodgkin
Keywords: Antigens, CD30 Antibody-Drug Conjugate Antibodies, Monoclonal Disease, Hodgkin Drug Therapy Hematologic Diseases Immunotherapy Lymphoma Monomethylauristatin E
Sponsor: Seagen Inc.
Start date: 2010-04-30; Completion date: 2020-04-27
Enrollment: 329 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).

Detailed description:

Arms: arm 1: brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion arm 2: placebo every 3 weeks by IV infusion
Interventions: intervention 1: brentuximab vedotin intervention 2: placebo
Intervention descriptions: intervention 1: Every 21 days by IV infusion (1.8 mg/kg) intervention 2: Every 21 days by IV infusion

Protocol documents:
Clinical trial NCT01886235
Conditions: Recurrent Melanoma Stage IA Skin Melanoma Stage IB Skin Melanoma Stage IIA Skin Melanoma Stage IIB Skin Melanoma Stage IIC Skin Melanoma Stage IIIA Skin Melanoma Stage IIIB Skin Melanoma Stage IIIC Skin Melanoma Stage IV Skin Melanoma
Sponsor: Roswell Park Cancer Institute
Start date: 2013-09-04; Completion date: 2020-05-06
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot clinical trial studies intravital microscopy for identifying tumor vessels in patients with stage IA-IV melanoma that is being removed by surgery. New imaging procedures, such as intravital microscopy, may determine the extent of melanoma.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the feasibility of performing intravital microscopy on accessible human melanoma tumors during their standard course of treatment (i.e., wide local excision). (Part I)

SECONDARY OBJECTIVES:

I. To determine the blood flow velocity of the tumor vessels and tissue penetration of fluorescein (fluorescein sodium) as a marker of tumor vessel permeability. (Part II)

OUTLINE:

Patients receive fluorescein sodium intravenously (IV) followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.

After completion of study treatment, patients are followed up at 3 weeks and then periodically for 5 years.

Arms: arm 1: Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
Interventions: intervention 1: Diagnostic Microscopy intervention 2: Fluorescein Sodium Injection intervention 3: Laboratory Biomarker Analysis intervention 4: Therapeutic Conventional Surgery
Intervention descriptions: intervention 1: Undergo intravital microscopy intervention 2: Given IV intervention 3: Correlative studies intervention 4: Undergo surgery

Protocol documents: