ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT04918823
Conditions: Ocular Surface Disease
Keywords: ocular surface disease Restasis
Sponsor: Boston Sight
Start date: 2021-07-15; Completion date: 2023-04-14
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this prospective observational pilot study is to evaluate the tolerability and safety of RESTASIS (cyclosporine ophthalmic solution 0.05%) when added to the PROSE (Prosthetic Replacement of the Ocular Surface Ecosystem) lens reservoir in patients with ocular surface disease (OSD). Secondary endpoints include early (1-month) efficacy data for ocular signs and symptoms.

Detailed description:
For this study, all subjects will receive Restasis (Cyclosporine ophthalmic emulsion 0.05%). One drop of the dispensed study drop will be instilled in the PROSE lens reservoir twice a day and the remainder of the reservoir will be filled with normal saline (0.9% sodium chloride solution). In order to standardize solutions used in the PROSE reservoir, all patients recruited will be either currently using or will be switched to buffered preservative-free normal saline (Purilens, Lifestyle Inc., pH 7.46 ) to better match the reported pH of RESTASIS (pH 6.5-8.05 ).

Outcomes will include subjective responses regarding the subject's symptoms and visual function in addition to the objective assessments of the health of the ocular surface seen on clinical examination. Results will be measured at baseline, after 1 week, and after 1 month of the study.

Arms: arm 1: All subjects will receive Restasis in this study
Interventions: intervention 1: Restasis
Intervention descriptions: intervention 1: Subject will use one drop of Restasis in the lens before insertion

Protocol documents:
Prot_002.pdf: 











































SAP_003.pdf:
Clinical trial NCT05653479
Conditions: Healthy
Sponsor: Upstream Bio Inc.
Start date: 2022-12-05; Completion date: 2023-05-13
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goals of this clinical study are to characterize and compare the safety, tolerability, blood levels of UPB-101 when given to healthy Japanese and non-Japanese non-East Asian (NJNEA) adults. Eligible participants will be assigned to one of the 4 planned dosing treatment groups. Treatment groups 1, 2 and 3 will consist of Japanese adults who will be administered a single subcutaneous (SC) dose of UPB-101 (at 3 different strengths). Treatment group 4 will consist of NJNEA participants who will receive a single SC dose of UPB-101. All treatment groups will enroll and run in parallel.

Detailed description:
This is a randomized, open-label, parallel group, ethno-bridging study comparing the pharmacokinetics and safety of a single dose of UPB-101 in healthy Japanese and NJNEA adults. The study will include 4 planned dosing treatment groups. Treatment groups 1, 2 and 3 will consist of Japanese adults who will be administered a single subcutaneous (SC) dose of UPB-101 (at 3 different strengths). Treatment group 4 will consist of NJNEA participants who will receive a single SC dose of UPB-101. All treatment groups will enroll and run in parallel. Japanese participants will be enrolled and randomized on Day 1 into treatment groups 1, 2 or 3 and NJNEA participants will be assigned to treatment group 4.

Eight participants will be enrolled per treatment group, all will receive a single dose of UPB-101. Thus, a total of 32 male and female participants will be enrolled in the study (24 Japanese participants in treatment groups 1-3 and 8 NJNEA participants in treatment group 4).

Arms: arm 1: Single subcutaneous injection of a low dose of UPB-101 (formerly ASP7266) in 8 Japanese participants arm 2: Single subcutaneous injection of a medium dose of UPB-101 (formerly ASP7266) in 8 Japanese participants arm 3: Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Japanese participants arm 4: Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Non-Japanese Non-East Asian participants
Interventions: intervention 1: UPB-101
Intervention descriptions: intervention 1: UPB-101 Subcutaneous injection

Protocol documents:
Prot_000.pdf: 













































































































































































SAP_001.pdf:
Clinical trial NCT02157883
Conditions: Advanced Non Small Cell Lung Cancer Advanced (Inoperable) Non Small Cell Lung Cancer
Keywords: oncology, cancer, non small cell lung cancer, anticancer drug, pharmacokinetics, AZD9291, intraconazole, EGFR sensitivity mutation
Sponsor: AstraZeneca
Start date: 2014-11-06; Completion date: 2023-05-17
Enrollment: 39 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
This is a 2 part study in patients with EGFRm+ non small cell lung cancer (NSCLC), whose disease has progressed on an EGFRm TKI, who are refractory or resistant to standard therapy. Part A will assess the effect of multiple oral doses of itraconazole on the single dose pharmacokinetic (PK) parameters of AZD9291. On completion of Part A, patients may continue to take AZD9291 tablets (Part B) following the collection of the 216 hour sample on Day 19 if they and the Investigator deem it appropriate, until such time as their disease progresses, the Investigator believes they are no longer deriving clinical benefit, or they stop taking AZD9291 for any other reason

Detailed description:

Arms: arm 1: Sequential treatments of AZD9291 alone followed by AZD9291+itraconazole, with a washout period in between.
Interventions: intervention 1: Pharmacokinetic sampling intervention 2: AZD9291 intervention 3: Itraconazole
Intervention descriptions: intervention 1: Blood samples taken pre and post dosing with AZD9291+/- itraconazole intervention 2: AZD9291 tablets: Part A 80mg od, days 1 and 10 only. Part B 80mg od for 12 months. intervention 3: Itraconazole tablets: 2x100mg bd, Part A days 6 to 19 only

Protocol documents:
Clinical trial NCT04120402
Conditions: Osteoarthritis, Knee
Sponsor: Eupraxia Pharmaceuticals Inc.
Start date: 2021-09-10; Completion date: 2023-06-01
Enrollment: 318 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of EP-104IAR in patients with osteoarthritis (OA) of the knee

Detailed description:
This is a randomized, double-blind, placebo-controlled, single injection, 24-week study to evaluate the safety, efficacy and PK of EP-104IAR in subjects with osteoarthritis knee pain

Following screening and baseline assessments to determine eligibility, each participant will receive a single IA injection of either EP-104IAR or placebo (vehicle). Participants will be followed up for 24 weeks following the injection for safety, PK and efficacy assessments.

Arms: arm 1: A single use intra-articular injection containing 25 mg of EP-104IAR arm 2: A single use intra-articular injection containing no active ingredients
Interventions: intervention 1: EP-104IAR 25 mg intervention 2: Vehicle
Intervention descriptions: intervention 1: Single 5 mL intra-articular injection intervention 2: Single 5 mL intra-articular injection

Protocol documents:
Prot_000.pdf: 
NCT04120402

































































































































































































































SAP_001.pdf: 
Statistical Analysis Plan
Sponsor:
Eupraxia Pharmaceuticals Inc.
Protocol No:
EP-104IAR-201
Protocol Title:
A Phase 2, Randomized, Double-Blind,
Vehicle-Controlled Study Evaluating the
Safety, Efficacy and Pharmacokinetics of
Single Dose EP-104IAR for 24 Weeks in
Patients with Osteoarthritis of the Knee
Document Date:
14-Jun-2023
Document Revision
Final 1.0
NCT04120402
Clinical trial NCT00863369
Conditions: Lymphoma
Keywords: recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult grade III lymphomatoid granulomatosis recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma adult grade III lymphomatoid granulomatosis
Sponsor: City of Hope Medical Center
Start date: 2005-06-29; Completion date: 2023-06-20
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with gemcitabine hydrochloride and rituximab may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib and gemcitabine hydrochloride when given together with rituximab and to see how well they work in treating patients with progressive or relapsed B-cell non-Hodgkin lymphoma.

Detailed description:
OBJECTIVES:

Primary:

I. To evaluate the safety and feasibility of combining VELCADE (bortezomib) with gemcitabine (gemcitabine hydrochloride) in patients with recurrent lymphoma after standard therapy.

II. To define the maximum tolerated dose (MTD) of gemcitabine and Rituxan (rituximab) administered in combination with VELCADE given on a 21-day (old schema - Schema I) or 28-day (amended schema - Schema II) schedule.

Secondary:

I. To obtain preliminary data for response to this regimen in this patient population.

OUTLINE: This is a phase I, dose-escalation study of bortezomib and gemcitabine hydrochloride followed by a phase II study.

Patients receive bortezomib intravenously (IV), gemcitabine hydrochloride IV over 3-4 hours, and rituximab IV on days 1 and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.

Arms: arm 1: Patients receive bortezomib IV, gemcitabine hydrochloride IV over 3-4 hours, and rituximab IV on days 1 and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: rituximab intervention 2: bortezomib intervention 3: gemcitabine hydrochloride intervention 4: questionnaire administration
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Ancillary studies

Protocol documents:
Clinical trial NCT05568615
Conditions: ALS
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2022-10-26; Completion date: 2023-06-27
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety of oral edaravone at a dose of 105 mg administered once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period. This study will be continued until the earlier date when oral edaravone is commercially available at each site in Japan or August 2023.

Detailed description:

Arms: arm 1: Subjects receive the edaravone oral suspension orally once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period.
Interventions: intervention 1: MT-1186
Intervention descriptions: intervention 1: Suspension

Protocol documents:
Prot_000.pdf: 











































































































































SAP_001.pdf:
Clinical trial NCT03389750
Conditions: Opioid Use Disorder
Sponsor: New York State Psychiatric Institute
Start date: 2018-03-15; Completion date: 2023-06-28
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Significant public health concerns have arisen from the intravenous misuse of oxymorphone, a potent mu-opioid pain medication. However, little is known about its abuse potential relative to other mu-opioid analgesics. The present study is designed to examine the abuse liability of intravenous oxymorphone compared to other mu opioid agonists (oxycodone, and hydromorphone) among physically dependent opioid abusers.

Detailed description:
Significant public health concerns have arisen from the misuse of oxymorphone, a potent mu-opioid pain medication approved by the Food and Drug Administration as Opana and Opana ER. However, little is known about its abuse potential relative to other mu opioid analgesics. The present study is designed to examine the abuse liability of intravenous oxymorphone compared to other mu opioid agonists (oxycodone and hydromorphone). Participants who are physically dependent on opioids and who meet DSM 5 criteria for Opioid Use Disorder will complete the study across 2 sites, New York State Psychiatric Institute (NYSPI) and the University of Kentucky; a total of 6 additional participants across 2 sites will complete a pilot phase of the study in order to establish comparable opioid dose-response functions based on subjective ratings of Drug Liking. All participants will reside in clinical inpatient units for the duration of the studies (both the 8- to 9-week main and 4- to 5-week pilot studies; please note that the pilot study is identical in design to the first 4-5 weeks of the main study). The study design is based on the 2017 FDA Assessment of Abuse Potential of Drugs: Guidance for Industry \[Center for Drug Evaluation and Research (CDER), 2017\], which suggests the use of a double-blind, positive- and placebo-controlled design that includes a qualification phase and VAS measure of Drug Liking. The proposed study also examines the reinforcing effects of oxymorphone and other mu opioid agonists using two different drug self-administration procedures, namely Drug versus Money and Drug versus Drug choice procedures.

Arms: arm 1: Intravenous (IV) Dose Range: 1.8, 3.2, 5.6, 10 mg/70kg of the participant's body weight arm 2: IV Dose Range: 10, 18, 32, 56 mg/70kg of the participant's body weight arm 3: IV Dose Range: 3.2, 5.6, 10, 18 mg/70kg of the participant's body weight arm 4: IV saline
Interventions: intervention 1: Intravenous Challenge Drug
Intervention descriptions: intervention 1: Intravenous administration of opioid drugs (oxycodone, oxymorphone, hydromorphone), for the purpose of comparison of their abuse potential among each other, and in comparison to placebo (saline).

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01063517
Conditions: Gastric Cancer
Keywords: Poly(ADP ribose) polymerase (PARP) Gastric cancer olaparib PARP inhibitor ATM AZD2281 Ku0059436 Homologous Recombination deficiency (HRD) Recurrent gastric cancer metastatic gastric cancer
Sponsor: AstraZeneca
Start date: 2010-02-02; Completion date: 2023-06-29
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy of olaparib when given in combination with paclitaxel compared with paclitaxel alone as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first-line therapy.

Detailed description:

Arms: arm 1: Olaparib + paclitaxel arm 2: paclitaxel + placebo
Interventions: intervention 1: olaparib intervention 2: paclitaxel intervention 3: Placebo
Intervention descriptions: intervention 1: 100mg BID oral tablet continuous intervention 2: iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle intervention 3: 100mg BID oral tablet to match olaparib tablet

Protocol documents:
Clinical trial NCT00278915
Conditions: Puberty, Precocious McCune-Albright Syndrome
Keywords: Progressive Precocious Puberty PPP McCune-Albright Syndrome MAS
Sponsor: AstraZeneca
Start date: 2006-01-31; Completion date: 2023-07-20
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (PPP) (early puberty) in girls with McCune-Albright syndrome (MAS)

Detailed description:

Arms: arm 1: Participants will receive intramuscular injection of fulvestrant 2 mg/kg or 4 mg/kg (First 10 participants will be dosed at 2 mg/kg then increased to 4 mg/kg. All subsequent participants will be dosed at 4 mg/kg) into the buttock or thigh monthly for 12 months or until the participant demonstrates lack of efficacy based upon one or more of the primary endpoints or experiences a serious drug-related toxicity requiring treatment discontinuation.
Interventions: intervention 1: Fulvestrant
Intervention descriptions: intervention 1: Participants will receive intramuscular injection of fulvestrant as stated in arm description.

Protocol documents:
Clinical trial NCT01472562
Conditions: Mantle Cell Lymphoma
Keywords: mantle cell lymphoma
Sponsor: Weill Medical College of Cornell University
Start date: 2011-07-29; Completion date: 2023-07-30
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II, multicenter study to determine the efficacy and safety of first-line lenalidomide plus rituximab therapy in patients with mantle cell lymphoma who have received no prior systemic therapy.

Detailed description:
Induction Phase (week 1 - 48):

* Lenalidomide will be given at 20 mg/day for days 1-21 of a 28-day cycle for 12 cycles. If no excess toxicity is observed the dose will be increased to 25 mg/day.
* Rituximab will be administered at 375 mg/m2 per dose for a total of 9 doses. The first 4 doses will be administered weekly starting on day 1 of lenalidomide (e.g. days 1, 8, 15 and 22). Subsequent rituximab doses will be administered for one dose each at weeks 12, 20, 28, 36 and 44.

Maintenance Phase (week 49 - progression of disease):

* Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle.
* Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52.

Response Assessment

* Year 1-2: Conventional restaging CT scan (or MRI) with IV contrast every 3 months from cycle 1 day 1 of the study.
* Year 3 onwards: Conventional restaging CT scan (or MRI) with IV contrast every 6 months until progression.

Arms: arm 1: Induction Phase (week 1 - 48):

* Lenalidomide will be given at 20 mg/day for days 1-21 of a 28-day cycle for 12 cycles. If no excess toxicity is observed the dose will be increased to 25 mg/day.
* Rituximab will be administered at 375 mg/m2 per dose for a total of 9 doses. The first 4 doses will be administered weekly starting on day 1 of lenalidomide (e.g. days 1, 8, 15 and 22). Subsequent rituximab doses will be administered for one dose each at weeks 12, 20, 28, 36 and 44.

Maintenance Phase (week 49 - progression of disease):

* Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle.
* Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52.
Interventions: intervention 1: lenalidomide intervention 2: rituximab
Intervention descriptions: intervention 1: Induction phase: 20 mg/day for days 1-21 of a 28-day cycle for 12 cycles. If no excess toxicity is observed the dose will be increased to 25 mg/day.

Maintenance phase: Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle. intervention 2: Induction phase: Rituximab will be administered at 375 mg/m2 per dose for a total of 9 doses. The first 4 doses will be administered weekly starting on day 1 of lenalidomide (e.g. days 1, 8, 15 and 22). Subsequent rituximab doses will be administered for one dose each at weeks 12, 20, 28, 36 and 44.

Maintenance phase: Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52.

Protocol documents:
Clinical trial NCT00965991
Conditions: Gestational Diabetes
Keywords: Gestational diabetes Metformin Glyburide oral agents
Sponsor: University of New Mexico
Start date: 2003-07-01; Completion date: 2023-08-01
Enrollment: 149 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Our hypothesis is that metformin and glyburide will have equal efficacy in controlling blood glucose in gestational diabetics with no increase in adverse maternal, fetal or neonatal outcomes.

Detailed description:
Pregnant women are screened with a one hour 50g glucose challenge. Women with values of 130 mg/dl or greater are then given a 100g glucose tolerance test. Two abnormal values are diagnostic of gestational diabetes. all women are initially counseled on diet and exercise. Women who fail to maintain a fasting of \<105mg/dl and 2 hr postprandial \< 120 mg/dl are offered participation in the study. Women were randomized to either metformin or glyburide via a computer generated randomization. Women who fail to meet glycemic goals after receiving the maximum dose of study medication were considered treatment failures and insulin therapy was initiated.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: metformin intervention 2: Glyburide
Intervention descriptions: intervention 1: patients received glyburide initial dose of 500 mg PO BID. Increased as necessary to a maximum dose of 2000 mg QD to control blood glucose intervention 2: Initial dose of 2.5mg PO BID increased as necessary to a maximum dose of 20 mg (10mg BID) QD to control blood glucose

Protocol documents:
Clinical trial NCT04577404
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Sponsor: Mitsubishi Tanabe Pharma America Inc.
Start date: 2020-10-29; Completion date: 2023-08-09
Enrollment: 124 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.

Detailed description:

Arms: arm 1: Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period
Interventions: intervention 1: MT-1186
Intervention descriptions: intervention 1: Treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period up to 96 weeks of treatment or until the drug is commercially available in that country.

Protocol documents:
Prot_000.pdf: 













































































































































SAP_001.pdf: