ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01314118
Conditions: Prostate Cancer Prostatic Neoplasm
Keywords: abiraterone acetate prednisone zytiga
Sponsor: Janssen Biotech, Inc.
Start date: 2011-05-04; Completion date: 2024-12-02
Enrollment: 131 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to show that abiraterone acetate plus prednisone added to the current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific antigen (PSA) and prolongs the time until it is evident that the cancer has grown. Additionally, safety information about abiraterone acetate in combination with prednisone will be collected. This will include looking at what side effects occur, how often they occur, and for how long they last.

Detailed description:
This is a Phase 2, prospective, multicenter, open-label, single-arm study of abiraterone acetate plus prednisone in men with non-metastatic, castration-resistant prostate cancer (CRPC) who have a rising PSA despite castrate levels of testosterone. The study consists of Screening Phase (up to 4 weeks), Core Study Treatment Phase (comprised of six 28-day cycles), a Pre-metastatic Disease Follow-up Phase, an Optional Drug Holiday Phase; and a 30-day Safety Follow-up Visit. Each treatment cycle will last 28 days. Participating participants will receive study agents (Abiraterone acetate 1000 mg/day plus prednisone 5 mg/day, orally) continually during the study. If the partcipants elects to participate in the Optional Drug Holiday Phase, participants will discontinue abiraterone acetate plus prednisone and ADT. Participants will have the option to return to study medication during the first year of the Optional Drug Holiday Phase if there is evidence of rising PSA but no metastasis based on study imaging. If participants do no elect to participate, they will continue with the core study treatment as per protocol. The study will end when all participated participants have disease progression or end of the 2-year period (if participants participated in the Optional Drug Holiday Phase). Participants will be required to return to the study site 30 days after receiving the last dose of abiraterone acetate for safety follow-up.

Arms: arm 1: abiraterone acetate in combination with prednisone Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily.
Interventions: intervention 1: abiraterone acetate in combination with prednisone
Intervention descriptions: intervention 1: Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily.

Protocol documents:
Clinical trial NCT05352763
Conditions: Alzheimer's Disease
Sponsor: Cassava Sciences, Inc.
Start date: 2022-05-12; Completion date: 2024-12-31
Enrollment: 90 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a 96-week extension study of open-label simufilam 100 mg b.i.d. for mild-to-moderate Alzheimer's disease subjects who completed the Phase 2 study, PTI-125-04. The study will evaluate safety and long-term treatment. Safety will be assessed by AE monitoring, clinical labs, urinalysis, vital signs, ECGs, and C-SSRS.

Detailed description:
This is an open-label 96-week extension study of open-label simufilam 100 mg b.i.d. for subjects who completed the Phase 2 study, PTI-125-04. All subjects will provide consent to enroll into this study. Simufilam will be administered as coated oral tablets. The last study visit, Month 24, from the PTI-125-04 study will be used for the Study Day 1 visit assessments in this extension study. Clinic visits will occur every 12 weeks ±10 days. A complete physical examination will be performed at Study Day 1, Week 48 and Week 96. Subjects will return to the clinic every 12 weeks for safety assessments of vital signs, AE monitoring, C-SSRS, and drug dispensation and accountability. Blood draws for clinical laboratory testing, urine collection for urinalysis, and ECGs will be performed at Study Day 1 and Weeks 24, 48, 72, and 96. Safety will be evaluated by adverse event monitoring, vital signs, clinical labs, and the Columbia Suicide Severity Rating Scale (C-SSRS).

Arms: arm 1: simufilam 100 mg oral tablets, b.i.d.
Interventions: intervention 1: simufilam
Intervention descriptions: intervention 1: simufilam 100 mg oral tablet, twice daily

Protocol documents:
Prot_000.pdf: 



















































































SAP_001.pdf:
Clinical trial NCT04552769
Conditions: Thyroid Cancer Anaplastic Thyroid Cancer Undifferentiated Thyroid Cancer
Sponsor: Stanford University
Start date: 2020-09-10; Completion date: 2025-01-05
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the efficacy of treatment with abemaciclib in patients with anaplastic thyroid/undifferentiated thyroid

Detailed description:
Primary Objective The primary objective is to determine the overall response rate after treatment with abemaciclib in patients with anaplastic thyroid/undifferentiated thyroid cancer.

Secondary Objectives The secondary objectives are to describe the overall survival (OS) and progression-free survival (PFS) after treatment with abemaciclib in patients with anaplastic thyroid/undifferentiated thyroid cancer.Safety assessments of AE's will also be analysed

Arms: arm 1: Each cycle of therapy will be 28 days long. A completed cycle will be twice daily abemaciclib. Number of Cycles: until progression or unacceptable toxicity develops
Interventions: intervention 1: Abemaciclib
Intervention descriptions: intervention 1: 200 mg orally

Protocol documents:
Prot_SAP_003.pdf:
Clinical trial NCT00777036
Conditions: Leukemia
Keywords: Leukemia, Pediatric
Sponsor: Bristol-Myers Squibb
Start date: 2009-03-20; Completion date: 2025-01-27
Enrollment: 133 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

Detailed description:

Arms: arm 1: Dasatinib 60 mg/m² tablet every day (QD) \[with a maximum dose of 100 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

OR

Dasatinib 72 mg/m² powder for oral suspension (PFOS) QD \[with a maximum dose of 120 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit arm 2: Dasatinib 80 mg/m² tablet QD \[with a maximum dose of 140 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

OR

Dasatinib 96 mg/m² PFOS QD \[with a maximum dose of 170 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit arm 3: Dasatinib 60 mg/m² tablet QD \[with a maximum dose of 100 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

OR

Dasatinib 72 mg/m² PFOS QD \[with a maximum dose of 120 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit
Interventions: intervention 1: Dasatinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01298323
Conditions: Locally Advanced or Metastatic Medullary Thyroid Cancer Medullary Thyroid Cancer
Keywords: Medullary Thyroid Cancer Locally advanced Metastatic Vandetanib Patient Outreach
Sponsor: Sanofi
Start date: 2011-02-25; Completion date: 2025-03-13
Enrollment: 205 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of patient outreach program on the proportion of time patients with MTC experience moderate or severe AEs during first 12 months of treatment with vandetanib

Detailed description:

Arms: arm 1: Control - treatment 300mg vandetanib opel label arm 2: Experimental - treatment 300mg vandetanib opel label
Interventions: intervention 1: Patient outreach intervention 2: Vandetanib
Intervention descriptions: intervention 1: Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner intervention 2: Treatment 300mg vandetanib opel label.

Protocol documents:
Clinical trial NCT02087423
Conditions: Non-Small Cell Lung Cancer
Keywords: Locally advanced, metastatic, Non-Small Cell Lung Cancer, MEDI4736, Durvalumab, PD-L1
Sponsor: AstraZeneca
Start date: 2014-02-25; Completion date: 2025-03-26
Enrollment: 446 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability

Detailed description:
This study is designed to investigate the efficacy, safety, tolerability of a new drug, MEDI4736 (Durvalumab), in patients with Locally Advanced or Metastatic Non Small Cell Lung Cancer. MEDI4736 will be investigated in patients who have received at least two prior treatment regimens including one platinum-based chemotherapy

Arms: arm 1: see below
Interventions: intervention 1: MEDI4736
Intervention descriptions: intervention 1: MEDI4736 (durvalumab) by intravenous infusion every two weeks. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier. Patients who achieve CR, PR or SD through the end of the initial 12-month treatment period can restart treatment with MEDI4736 (durvalumab) when they eventually do progress. This retreatment period can continue for as long as the investigator considers to patient to be receiving clinical benefit.

Protocol documents:
Clinical trial NCT01065454
Conditions: Hypertension, Pulmonary Ventricular Dysfunction, Left
Keywords: Pulmonary Hypertension Left ventricular dysfunction
Sponsor: Bayer
Start date: 2010-04-14; Completion date: 2025-07-23
Enrollment: 202 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

Detailed description:
Pharmacokinetics parameters were regarded as exploratory parameters. Adverse event data will be covered in Adverse events section.

Arms: arm 1: Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg). arm 2: Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg). arm 3: Participants received riociguat 0.5 mg tid (fixed dose). arm 4: Participants received placebo tid.
Interventions: intervention 1: Riociguat (Adempas, BAY63-2521) intervention 2: Riociguat (Adempas, BAY63-2521) intervention 3: Riociguat (Adempas, BAY63-2521) intervention 4: Placebo
Intervention descriptions: intervention 1: up to 2 mg three times a day (increasing from 0.5 to 1 to 2 mg) intervention 2: up to 1 mg three times a day (increasing from 0.5 to 1 mg) intervention 3: fixed 0.5 mg three times a day intervention 4: Placebo three times a day

Protocol documents: