ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01673867
Conditions: Non-Squamous Cell Non-small Cell Lung Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2012-11-02; Completion date: 2021-12-17
Enrollment: 582 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy

Detailed description:
CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057

Arms: arm 1: Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends. arm 2: Docetaxel 75 mg/m\^2 concentrate for solution for intravenous infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Interventions: intervention 1: Nivolumab intervention 2: Docetaxel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT05109117
Conditions: Sunscreening Agents
Sponsor: HALEON
Start date: 2021-12-07; Completion date: 2021-12-17
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the 8-hour moisturization efficacy of OTC sunscreen lip balm after a single treatment application.

Detailed description:
A single-center, randomized, controlled, intra-individual comparison, open label clinical study to determine the 8-hour moisturization efficacy of a sunscreen lip balm. Skin hydration will be assessed before (Baseline) and after (2, 4, 6 and 8 hours post-treatment) a single treatment with test product, compared to 'no treatment' as control, using a corneometer. Study treatments will be randomly assigned to 2 test sites delineated on the skin of the participant's volar forearms (one test site on each arm). A 1-week conditioning phase will precede the test day, during which participants will use the soap provided for personal washing.

Arms: arm 1: Single topical application: 80 +/- 2 milligrams (mg) (2.0 +/- 0.05 mg/centimeter\^2) of ChapStick Active Performance (CAP) Unscented will be applied to the assigned test site using a fingercot. The test product will be evenly spread over the test site using light pressure. arm 2: No treatment will be applied to the assigned control site.
Interventions: intervention 1: CAP Unscented
Intervention descriptions: intervention 1: Sunscreen lip balm.

Protocol documents:
Prot_SAP_000.pdf: 
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Clinical trial NCT01669915
Conditions: Cognitive Decline
Sponsor: Brigham and Women's Hospital
Start date: 2011-09-14; Completion date: 2021-12-31
Enrollment: 3424 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil is associated with cognitive decline in 3000 older participants of VITAL.

Detailed description:
Primary aim of annual rate of cognitive decline. Secondary aims will be addressed in sub-set of participants: 1) among participants, African-American race (African-Americans have high risk of Vitamin D deficiency) modifies effects of vitamin D3 supplementation on cognitive decline; 2) among a subset of participants, baseline plasma levels of vitamin D and omega-3 fatty acids modify agent effects.

Arms: arm 1: ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]). arm 2: ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day arm 3: PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]). arm 4: PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
Interventions: intervention 1: vitamin D3 intervention 2: omega-3 fatty acids (fish oil) intervention 3: Vitamin D3 placebo intervention 4: Fish oil placebo
Intervention descriptions: intervention 1: Vitamin D3 (cholecalciferol), 2000 IU per day intervention 2: Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]). intervention 3: Vitamin D placebo intervention 4: Fish oil placebo

Protocol documents:
Clinical trial NCT01831076
Conditions: Breast Cancer Stage II Breast Cancer Stage III Breast Cancer
Keywords: Breast cancer estrogen receptor-positive breast cancer progesterone receptor-positive breast cancer Postmenopausal Exemestane Tamoxifen
Sponsor: University of Colorado, Denver
Start date: 2002-04-01; Completion date: 2022-01-06
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II trial studies how well exemestane before surgery works in treating postmenopausal patients with newly diagnosed estrogen receptor positive stage II-III breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells.

Detailed description:
This study will develop preliminary data regarding the efficacy and safety of exemestane in the preoperative treatment of postmenopausal women with ER+ or PR+ tumors. This trial is also designed to develop a predictive model to correlate expression of the known isoforms of ER and progesterone receptor (PR) and the aromatase enzyme with response to estrogenic deprivation using exemestane.

Arms: arm 1: Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. arm 2: Patients receive exemestane plus tamoxifen orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
Interventions: intervention 1: Exemestane intervention 2: Exemestane and tamoxifen
Intervention descriptions: intervention 1: Given PO intervention 2: exemestane 25 mg po daily and tamoxifen 20 mg po daily given concurrently for 4 months prior to surgery

Protocol documents:
Clinical trial NCT04908514
Conditions: Plaque Psoriasis
Sponsor: Aldeyra Therapeutics, Inc.
Start date: 2021-05-07; Completion date: 2022-01-21
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A Multi-Center, Open-Label, Phase 2 Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of ADX-629 Administered Orally to Subjects with Plaque Psoriasis

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: ADX-629
Intervention descriptions: intervention 1: ADX-629 administered orally twice daily (BID) for approximately 12 weeks.

Protocol documents:
Prot_000.pdf: 





































































































































































SAP_001.pdf:
Clinical trial NCT01774721
Conditions: Non-small Cell Lung Cancer With EGFR-Activating Mutations
Keywords: first-line locally advanced or metastatic non-small cell lung cancer epidermal growth factor receptor EGFR ARCHER mutation dacomitinib PF-00299804
Sponsor: Pfizer
Start date: 2013-05-09; Completion date: 2022-01-27
Enrollment: 452 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
This is a multinational, multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of treatment with dacomitinib (PF-00299804) to treatment with gefitinib in patients with locally advanced or metastatic non-small cell lung cancer, with epidermal growth factor receptor EGFR-activating mutation (s). Analyses of primary objective (Progression Free Survival) will be done as defined in the protocol.

Detailed description:
452 patients were randomized in a 1:1 ratio between dacomitinib (PF-00299804 ) vs. gefitinib.

Arms: arm 1: Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing. arm 2: Gefitinib is provided as 250 mg tablets, continuous oral daily dosing.
Interventions: intervention 1: Dacomitinib (PF-00299804) intervention 2: Gefitinib
Intervention descriptions: intervention 1: Dacomitinib (PF-00299804) 45 mg tablets, continuous oral daily dosing. intervention 2: Gefitinib 250 mg tablets, continuous oral daily dosing.

Protocol documents:
Clinical trial NCT04555694
Conditions: Dry Eye
Sponsor: Thomas Chester, OD
Start date: 2020-10-01; Completion date: 2022-02-16
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 6 month study seeks to compare the use of Intracanalicular Dexamethasone in conjunction with Restasis (cyclosporine ophthalmic emulsion) for the treatment of signs and symptoms of dry eye disease as compared to Restasis with Lotemax (loteprednol etabonate ophthalmic suspension 0.5%) and Restasis monotherapy.

Detailed description:

Arms: arm 1: 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes. arm 2: 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids. arm 3: 10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
Interventions: intervention 1: Cyclosporine intervention 2: Loteprednol Etabonate intervention 3: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
Intervention descriptions: intervention 1: Used to increase tear production in patients who have dry eye caused by inflammation intervention 2: Used to treat inflammation of the eye intervention 3: Used to treat inflammation of the eye

Protocol documents:
Prot_000.pdf: 











































SAP_001.pdf:
Clinical trial NCT04688671
Conditions: Diabetic Peripheral Neuropathic Pain Diabetic Peripheral Neuropathy
Sponsor: Eliem Therapeutics (UK) Ltd.
Start date: 2020-11-09; Completion date: 2022-02-18
Enrollment: 167 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects with Diabetic Peripheral Neuropathic Pain.

Detailed description:
ETX-018810 is a new chemical entity that is under development as a non-opioid treatment for chronic pain syndromes. ETX-018810 is a prodrug of palmitoylethanolamide (PEA), an endogenous bioactive lipid that has shown efficacy in a broad range of nonclinical inflammatory and neuropathic pain models and in clinical trials in chronic pain indications, including diabetic peripheral neuropathic pain (DPNP).

Arms: arm 1: 1000 mg BID for 4 weeks arm 2: matching placebo BID for 4 weeks
Interventions: intervention 1: ETX-018810 intervention 2: Placebo
Intervention descriptions: intervention 1: Study Drug intervention 2: Matching Placebo

Protocol documents:
Prot_SAP_001.pdf: 
Synopsis ETX-018810-202 
 
ETX-018810 
 
 
Eliem Therapeutics (UK) Ltd 
 
Confidential 
Page 1 of 7 
Version 1.0, 07 July 2020 
 
 
 
Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to 
Evaluate the Efficacy and Safety of ETX-018810 in Subjects with Diabetic Peripheral 
Neuropathic Pain 
 
NCT Number: 04688671 
 
Document Date: 7th July 2020 
 
 
 












Synopsis ETX-018810-202 
 
ETX-018810 
 
 
Eliem Therapeutics (UK) Ltd 
 
Confidential 
Page 7 of 7 
Version 1.0, 07 July 2020 
 
The treatment comparison for the change from baseline at Week 4 was estimated using a Mixed 
Model Repeated Measures (MMRM), which included the baseline score as a covariate; treatment 
group, visit (week), and the treatment-by-visit (week) as fixed effects; and a repeated structure 
that acknowledged the visits within a subject using an unstructured covariance structure. The 
Kenward-Rogers (1997) approximation was used to estimate the denominator degrees of 
freedom. The estimate, standard error, 90% CI, and associated p-value (2-sided) were presented.
Clinical trial NCT02875132
Conditions: Acral Lentiginous Melanoma
Sponsor: Chinese University of Hong Kong
Start date: 2017-02-15; Completion date: 2022-02-28
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the Overall Response Rate (ORR), as defined as rate of complete response (CR) and partial response (PR) as per RECIST 1.1 in biological treatment-naïve patients with acral lentiginous melanoma treated with pembrolizumab

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: pembrolizumab
Intervention descriptions: intervention 1: pembrolizumab at 200mg IV infusion every 3 weeks

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT04685993
Conditions: NASH - Nonalcoholic Steatohepatitis
Sponsor: Lipocine Inc.
Start date: 2020-11-11; Completion date: 2022-03-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.

Detailed description:
This is a multicenter, open-label extension protocol to provide LPCN 1144, an investigational drug, to subjects with NASH who have completed the LPCN 1144-18-002 protocol. Enrolled subjects will be given LPCN 1144 for up to 36 weeks. Subjects will be seen periodically to evaluate safety clinical laboratory tests, tolerability of LPCN 1144, adverse events, and overall subject health. Subjects will be given the option of having a liver biopsy performed at Week 36.

Arms: arm 1: LPCN 1144
Interventions: intervention 1: LPCN 1144
Intervention descriptions: intervention 1: Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT04276415
Conditions: Gastrointestinal Stromal Tumors
Keywords: Gastrointestinal stromal tumors DS-6157a Anti-drug antibody conjugate G-protein coupled receptor 20 (GPR20)
Sponsor: Daiichi Sankyo
Start date: 2020-05-08; Completion date: 2022-03-11
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This study will assess the safety, efficacy, and pharmacokinetics of DS-6157a in participants with advanced gastrointestinal stromal tumors (GIST).

Detailed description:
This study is a two-part, multicenter, open-label, multiple-dose, first-in-human study of the antibody-drug conjugate (ADC) DS-6157a given as a single agent to participants with gastrointestinal stromal tumor (GIST).

This study will include 2 parts:

1. Dose Escalation (Part 1)
2. Dose Expansion (Part 2)

Dose Escalation: Participants with histopathologically documented advanced GIST not amenable to curative therapy may be included in which the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of DS-6157a monotherapy will be determined.

Dose Expansion: Once the RDE(s) is established for DS-6157a (Part 1), enrollment in Dose Expansion (Part 2) will commence in 2 cohorts. Participants with GIST who have progressed on or are intolerant to imatinib (IM) and at least one post-IM treatment will be enrolled in Cohort 1, and participants with GIST who progressed on IM and had not received a post-IM treatment (2nd line) will be enrolled in Cohort 2.

The study was terminated after Dose Escalation and the study never proceeded to the Dose Expansion part.

Arms: arm 1: Participants with advanced gastrointestinal stromal tumor (GIST) who will receive an intravenous infusion of DS-6157a (escalating doses starting at 1.6 mg/kg). arm 2: Participants with advanced gastrointestinal stromal tumor (GIST) who have progressed on or are intolerant to imatinib (IM) and at least one post-IM treatment will receive DS-6157a at the recommended dose for expansion (RDE) based on the Dose Escalation phase. arm 3: Participants with advanced gastrointestinal stromal tumor (GIST) who have progressed on imatinib (IM) and had not received a post-IM treatment (2nd line) will receive DS-6157a at the recommended dose for expansion (RDE) based on the Dose Escalation phase.
Interventions: intervention 1: DS-6157a
Intervention descriptions: intervention 1: Administered as a single agent intravenously (IV) every 3 weeks

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT03290196
Conditions: Rotator Cuff Tear
Keywords: Shoulder Rotator cuff
Sponsor: Andrews Research & Education Foundation
Start date: 2015-09-03; Completion date: 2022-04-07
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients undergoing shoulder rotator cuff surgery in an outpatient setting are the focus of this study. The purpose of this study is to determine if the product EXPAREL® can be used as a safe alternative in shoulder surgery to pain pumps, while limiting narcotic use and providing appropriate postoperative pain control.

Detailed description:
Based on prior research, it is hypothesized EXPAREL® can potentially be used as a local anesthetic option after undergoing an arthroscopic rotator cuff repair in the outpatient setting. Conducting this study, will allow the option for a surgeon to administer a local anesthetic, in a single injection, to the exact location of the surgical procedure and in a sterile environment. The purpose of this pilot study is to determine if EXPAREL® can be used as a safe alternative to current post-operative pain control methods, while limiting narcotic use and providing appropriate postoperative analgesia.

Arms: arm 1: EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% \[13.3 mg/mL\]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors:

* size of surgical site
* volume required to cover the area
* individual patient factors that may impact the safety of an amide local anesthetic
* maximum doe of 266 mg (20 mL)
Interventions: intervention 1: EXPAREL 1.3 % in 20 ML Injection
Intervention descriptions: intervention 1: EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.

Protocol documents:
Clinical trial NCT04223609
Conditions: Healthy
Sponsor: Mayo Clinic
Start date: 2020-02-28; Completion date: 2022-04-11
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Research is being conducted to better understand the physiologic effects (relating to the action of a drug when taken by a healthy person) of opioid use on oculomotor (relating to the motion of the eye) dynamics and to identify the presence of characteristics consistent with a specific drug or class of drugs.

Detailed description:

Arms: arm 1: Participants first receive initial dose of oxycodone 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a standardized set of oculomotor testing for 40 minutes. After the initial testing, a second dose of oxycodone 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes. Participants will then return approximately 4 to 6 days to repeat the standardized oculomotor testing with placebo. arm 2: Participants first receive initial dose of placebo 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a set of standardized oculomotor testing for 40 minutes. After the initial testing, a second dose of placebo 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes. Participants will then return approximately 4 to 6 days to repeat the standardized oculomotor testing with oxycodone.
Interventions: intervention 1: Oxycodone intervention 2: Placebo intervention 3: EyeLink 1000 Plus intervention 4: Oculo-Cognitive Addition test (OCAT) intervention 5: VT3mini - Eye Tracking Technology for OEMs
Intervention descriptions: intervention 1: 5 mg tablet intervention 2: Oxycodone-matched placebo tablet intervention 3: Non-invasive video-based eye tracking system intervention 4: Subject will have to look for numbers on a screen and add these numbers together. OCAT will be presented on a computer screen with attached eye tracking device at the bottom part. intervention 5: Non-invasive eye-tracking device

Protocol documents:
Prot_SAP_000.pdf: 
 
 
Non-intrusive Detection of Temporary 
Neurologic Impairment By Opioids 
 
NCT04223609 
 
November 1, 2021
Clinical trial NCT00529763
Conditions: Leukemia
Keywords: Chronic Phase, Advanced Phase chronic myeloid leukemia Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Sponsor: Bristol-Myers Squibb
Start date: 2007-11-17; Completion date: 2022-04-20
Enrollment: 121 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to estimate the major cytogenetic response (MCyR) rate to Dasatinib in subjects with CP CML, complete and overall hematologic response (CHR and OHR) rate in subjects with AD CML or Ph+ ALL who have primary or acquired resistance to imatinib, or are intolerant of imatinib, when administered at 100 mg QD (Chronic CML) or 70mg BID (AP CML and Ph+ALL).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Dasatinib
Intervention descriptions: intervention 1: Tablets, Oral, 70 mg BID (AD CML) or 100 mg QD (Chronic CML), once or twice daily dependent on disease stage, until subjects meet discontinuation (DC) criteria for study

Protocol documents: