ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03520569
Conditions: Vascular Stiffness Insulin Sensitivity
Sponsor: University of Virginia
Start date: 2019-02-04; Completion date: 2021-04-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators are studying the effects of Hyperglycemia on vascular function and insulin sensitivity on healthy adults

Detailed description:
The investigators will study 22 healthy subjects (18-35 yrs) four times as follows:

1. Saline + Octreotide + euglycemia;
2. Octreotide + hyperglycemia;
3. Octreotide + hyperglycemia + insulin clamp and
4. Octreotide + Euglycemia + insulin clamp.

The sequence of admissions will be assigned randomly. The investigators will assess function in conduit (pulse wave velocity-PWV, augmentation index-AI and flow-mediated dilation-FMD), resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular (contrast enhanced ultrasound-CEU) vessels.

This work will:

a) identify whether vascular stiffness and indices of NO action are impaired throughout the arterial tree with hyperglycemia.

Arms: arm 1: octreotide is 30 ng/kg/min x 240 min insulin 0.15mU/kg/min x 240 min Dextrose 20% at variable rate to maintain euglycemia for 240 min arm 2: octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 330 min arm 3: octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 330 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min arm 4: octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
Interventions: intervention 1: Octreotide intervention 2: Insulin intervention 3: Dextrose 20% solution
Intervention descriptions: intervention 1: we are using it to block insulin secretion from the pancreas intervention 2: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp intervention 3: We are using dextrose to maintain glycemia level

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT04776135
Conditions: Healthy Adult Subjects
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2021-02-26; Completion date: 2021-04-16
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate the comparative bioavailability of edaravone oral suspension administered orally and via a nasogastric tube in healthy adult subjects

Detailed description:

Arms: arm 1: Subjects receive the edaravone oral suspension orally. arm 2: Subjects receive the edaravone oral suspension via a nasogastric tube
Interventions: intervention 1: MT-1186
Intervention descriptions: intervention 1: Suspension

Protocol documents:
Prot_000.pdf: 







































































































































SAP_001.pdf:
Clinical trial NCT01239797
Conditions: Lymphoma Multiple Myeloma
Sponsor: Bristol-Myers Squibb
Start date: 2011-06-20; Completion date: 2021-04-21
Enrollment: 646 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lenalidomide intervention 2: Dexamethasone intervention 3: Dexamethasone (Oral) intervention 4: Dexamethasone (IV) intervention 5: Elotuzumab (BMS-901608; HuLuc63)
Intervention descriptions: intervention 1: Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug intervention 2: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug intervention 3: On weeks without Elotuzumab dosing: Tablets, Oral, 40mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug.

On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug intervention 4: On weeks without Elotuzumab dosing: Not Applicable (N/A)

On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly, Repeat every 28 days until subject meets criteria for discontinuation of study drug intervention 5: Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Protocol documents:
Clinical trial NCT01721759
Conditions: Squamous Cell Non-small Cell Lung Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2012-11-16; Completion date: 2021-04-22
Enrollment: 117 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to assess the objective response rate (change in tumor size from baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens

Detailed description:

Arms: arm 1: Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
Interventions: intervention 1: Nivolumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00920816
Conditions: Kidney Neoplasms
Keywords: Axitinib in First & Second Line Treatment of Patients With Metastatic Renal Cell Cancer
Sponsor: Pfizer
Start date: 2009-08-25; Completion date: 2021-04-29
Enrollment: 492 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Axitinib (AG-013736) intervention 2: Sorafenib
Intervention descriptions: intervention 1: axitinib will be given at a starting dose of 5 mg BID with continuous dosing intervention 2: sorafenib will be given at a dose of 400 mg BID continuous dosing

Protocol documents:
Clinical trial NCT04617860
Conditions: Huntington Disease
Sponsor: Wave Life Sciences Ltd.
Start date: 2019-09-24; Completion date: 2021-04-29
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
WVE-HDSNP2-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120102 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362331 (SNP2). To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP2-001.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: WVE-120102
Intervention descriptions: intervention 1: WVE-120102 is a stereopure antisense oligonucleotide. It is administered monthly via intrathecal injection.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT04178993
Conditions: Methamphetamine Use Disorder
Keywords: Methamphetamine Methylphenidate Duloxetine Hydrochloride Central Nervous System Stimulants Physiological Effects of Drugs Dopamine Uptake Inhibitors Serotonin and Noradrenaline Reuptake Inhibitors Membrane Transport Modulators Neurotransmitter Agents Dopamine Agents Molecular Mechanisms of Pharmacological Action Sensory System Agents Peripheral Nervous System Agents Vasoconstrictor Agents Antidepressive Agents Psychotropic Drugs
Sponsor: Craig Rush
Start date: 2019-09-01; Completion date: 2021-05-05
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study will evaluate the behavioral effects of methamphetamine during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods.

Detailed description:

Arms: arm 1: Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. arm 2: Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.
Interventions: intervention 1: Methamphetamine intervention 2: Methylphenidate intervention 3: Placebo oral capsule intervention 4: Duloxetine
Intervention descriptions: intervention 1: In each arm, subjects will receive doses of methamphetamine. intervention 2: In each arm, subjects will receive methylphenidate capsules. intervention 3: In each arm, subjects will receive placebo capsules. intervention 4: Subjects will receive duloxetine capsules in the duloxetine arm.

Protocol documents:
Prot_SAP_ICF_001.pdf: 
Document Coversheet 
 
Study Title: A Novel Drug Combination as a Pharmacotherapeutic for Methamphetamine-Use 
Disorder    
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
ICF 3/18/21; protocol 7/8/19 
NCT Number: 
NCT04178993 
IRB Number 
51704 
Coversheet created: AWR 
11/11/22 
 
 


Section 1 Page 1 of 1
Clinical trial NCT05740371
Conditions: Stable Coronary Artery Disease (CAD) Unstable Angina (Troponin Negative)
Sponsor: Mitsubishi Tanabe Pharma GmbH
Start date: 2017-04-18; Completion date: 2021-05-06
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine change of QTc interval during intravenous argatroban infusion in patients undergoing percutaneous coronary intervention (PCI)

Detailed description:
Primary objective:

To determine change of corrected QT interval (QTc) during intravenous argatroban infusion in patients undergoing percutaneous coronary intervention (PCI).

Secondary objectives:

* Determination of the QTc interval after sufficient wash-out period by ECG-3 which needed to be performed \> 8 but ≤ 28 hours after termination of prolonged argatroban infusion.
* Investigation of dependence of QTc interval on gender and applied doses.
* Determination of coagulation status during argatroban therapy.
* Assessment of safety-related events within the scope of anticoagulation with argatroban, for example bleeding events or thromboembolic events.

Arms: arm 1: None
Interventions: intervention 1: Argatroban
Intervention descriptions: intervention 1: Patients received an intravenous (i.v.) bolus of 300 μg/kg argatroban administered over a span of 3 to 5 minutes followed by the i.v. infusion of argatroban at 20 μg/kg/min until the end of the procedure. ACT was checked 5 minutes after bolus dose.

If ACT remained below the target of 300 s, the patient received an additional i.v. bolus injection of 150 μg/kg and the infusion dose was raised up to 30 μg/kg/min.

In cases ACT \> 450 s, the infusion was reduced to 15 μg/kg/min and the value was checked again after 5 minutes.

As soon as the target ACT (between 300 s and 450 s) was reached, infusion dose remained unchanged during the PCI procedure.

Depending on clinical relevancy further ACT assessments were possible.

Protocol documents:
Prot_000.pdf: 



































































































SAP_001.pdf:
Clinical trial NCT01721772
Conditions: Melanoma
Sponsor: Bristol-Myers Squibb
Start date: 2013-01-18; Completion date: 2021-05-14
Enrollment: 418 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma

Detailed description:

Arms: arm 1: Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may switch to nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends. arm 2: Participants received dacarbazine, 1000 mg/m\^2, solution administered IV every 3 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion. Eligible participants may cross-over to nivolumab open label treatment, either 3 mg/kg every 2 weeks or 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Interventions: intervention 1: BMS-936558 (Nivolumab) intervention 2: Placebo matching BMS-936558 (Nivolumab) intervention 3: Dacarbazine intervention 4: Placebo matching Dacarbazine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT04360174
Conditions: Ocular Hypertension Open Angle Glaucoma
Sponsor: Ocular Therapeutix, Inc.
Start date: 2018-04-25; Completion date: 2021-05-24
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.

Detailed description:
This is a prospective, multicenter, open label study, to evaluate the safety, tolerability and efficacy of OTX-TIC intracameral implant in subjects with primary open-angle glaucoma or ocular hypertension. The subjects will be followed for approximately 7 months (one-month washout and 6 months follow-up after injected of the OTX-TIC implant).

Arms: arm 1: 15 µg (formulation1) implant arm 2: 26 µg (formulation1) implant arm 3: 15 µg (formulation 2) implant arm 4: 5 µg (formulation 3) implant
Interventions: intervention 1: OTX-TIC
Intervention descriptions: intervention 1: OTX-TIC implant is injection in the anterior chamber of the eye

Protocol documents:
Prot_000.pdf: 
A prospective, multi-center, open-label study to 
evaluate the safety, tolerability and efficacy of 
OTX-TIC (travoprost) intracameral implant in 
subjects with primary open-angle glaucoma 
(OAG) or ocular hypertension (OHT) 
NCT04360174 
July 28, 2020 












• Anterior segment (AS)-OCT 
• Automatic Visual Field 
 
 
 
Study Outcome 
Measure 
 
• Diurnal IOP (8 a.m., 10 a.m., 4 p.m.) will be checked at 
baseline, Day 14 (Visit 5), Day 42 (Visit 7), Day 85 (Visit 
8), Month 4 (Visit 9), and Month 6 (Visit 11). IOP will 
continue to be measured if biological activity is noted at 
Month 6. 
• Intraocular pressure (at 8 a.m. on the day of insertion; Days 
3, 7, and 28; and Month 5 [Visit 10]) 
Procedural Exclusion 
Criteria 
Unsuccessful intracameral injection (record reason for injection 
failure on the electronic Case Report Form, i.e., eCRF); in the case 
of injection failure do not attempt another injection. The study will 
be supplemented with additional subjects to account for these 
subjects in order to ensure that the necessary number of subjects 
receive the implant to inform on safety, tolerability and efficacy. 
 

SAP_001.pdf: 
A prospective, multi-center, open-label study to 
evaluate the safety, tolerability and efficacy of 
OTX-TIC (travoprost) intracameral implant in 
subjects with primary open-angle glaucoma 
(OAG) or ocular hypertension (OHT) 
NCT04360174 
July 28, 2020
Clinical trial NCT02197247
Conditions: Non Small Cell Lung Cancer
Keywords: oncology, cancer, non small cell lung cancer, anticancer drug, pharmacokinetics, AZD9291, rifampicin, CYP P450 inducer, EGFR genes
Sponsor: AstraZeneca
Start date: 2014-12-04; Completion date: 2021-05-26
Enrollment: 41 participants; Allocation: ; Intervention model: 

Brief summary:
This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase inhibitor (TKI) agent.

Part A will assess the effect of rifampicin on the pharmacokinetic (PK) parameters of AZD9291 and metabolites AZ5104 and AZ7550 following multiple oral dosing of both rifampicin and AZD9291 in a fasted state.

Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will provide for additional safety data collection. All patients who complete Part A will be able to enter part B, and continue to receive AZD9291 80 mg once daily until: disease progression; they are no longer deriving clinical benefit; or any other reason.

Detailed description:

Arms: arm 1: Sequential treatments of AZD9291 alone followed by AZD9291 +rifampicin, followed by AZD9291 alone.
Interventions: intervention 1: Pharmacokinetic sampling - AZD9291 intervention 2: Rifampicin intervention 3: AZD9291 tablet dosing intervention 4: Pharmacokinetic sampling - rifampicin intervention 5: Pharmacokinetic sampling - AZ5140 and AZ7550
Intervention descriptions: intervention 1: Blood sampling to measure AZD9291 intervention 2: Rifampicin (CYP inducer) 600mg taken once daily from Day 29 to Day 49 (Part A) intervention 3: Part A: AZD9291 80mg tablet taken daily from Days 1 to 77. Part B: AZD9291 80mg tablet taken daily for 12 months. intervention 4: Blood sampling to measure rifampicin levels intervention 5: Blood samples to measure levels of AZ5140 and AZ7550

Protocol documents:
Clinical trial NCT02546492
Conditions: Transplant Glomerulopathy
Sponsor: University of Maryland, Baltimore
Start date: 2016-08-01; Completion date: 2021-05-27
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label safety and feasibility trial using Acthar® in addition to the investigators center-specific standard therapy, which could include increase in maintenance immunosuppression, high dose IVIG (intravenous immunoglobulin) (2 g/Kg), and/or Rituximab, in patients with chronic antibody-mediated rejection (CAMR).

Detailed description:
Subjects will receive Acthar® 40 units twice a week subcutaneously for 2 weeks. If the drug is well tolerated the dose will be increased to 80 units twice a week for another 22 weeks. The patients will be maintained on their center-specific standard maintenance regimen, typically consisting of Tacrolimus, mycephenolate mofetil/Sodium, and prednisone.

After screening for the inclusion/exclusion criteria, the patients will be consented and enrolled in the study. The initial visit and subsequent study-related visits at 4, 8, 12, 24, 36 and 52 weeks will include routine evaluation and physical examination and laboratory studies including CBC (complete blood count), electrolyte panel, eGFR, albumin, liver enzymes, and Calcineurin inhibitor (CNI)/sirolimus drug level, according to the center's standard of care. Donor-specific antibody (DSA) will be tested at week 24, and 52 and patients will undergo a biopsy at week 52, as a part of the investigators standard of care. The biopsies will be evaluated by light and electron microscopy using standard histological Banff criteria, and staining for CD68.

Arms: arm 1: The study cohort. In this cohort Acthar gel will be administered to the enrolled patient with chrnic AMR.
Interventions: intervention 1: Acthar gel
Intervention descriptions: intervention 1: Administration of the study drug in addition to the current maintenance immunosuppressive agents

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01721876
Conditions: Leukemia, Myeloid, Acute
Sponsor: Boehringer Ingelheim
Start date: 2013-01-29; Completion date: 2021-05-28
Enrollment: 666 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low dose cytarabine in patients \>= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: Volasertib intervention 3: Cytarabine
Intervention descriptions: intervention 1: Placebo matching Volasertib intervention 2: Volasertib intervention 3: Cytarabine

Protocol documents:
Clinical trial NCT00072462
Conditions: Breast Cancer
Keywords: ductal breast carcinoma in situ breast cancer in situ
Sponsor: Queen Mary University of London
Start date: 2003-09-01; Completion date: 2021-05-31
Enrollment: 2980 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It is not yet known whether tamoxifen is more effective than anastrozole in preventing breast cancer after surgery for ductal carcinoma in situ.

PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works compared to anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ.

Detailed description:
OBJECTIVES:

Primary

* Compare the efficacy of adjuvant tamoxifen vs anastrozole, in terms of local control and prevention of contralateral disease, in postmenopausal women with locally excised ductal carcinoma in situ.
* Compare side effect profiles of these drugs in these patients.

Secondary

* Compare the efficacy of these drugs, according to the receptor status of the primary or recurrent cancer in these patients.
* Compare the rate of breast cancer recurrence and growth of new contralateral tumors after cessation of treatment with these drugs in these patients.
* Compare breast cancer mortality in patients treated with these drugs.
* Compare the effect of these drugs on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these patients.
* Compare the tolerability and acceptability of side effects experienced by patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, multicentre study. Patients are stratified according to participating centre. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral tamoxifen and oral placebo once daily.
* Arm II: Patients receive oral anastrozole and oral placebo once daily. In both arms, treatment continues for 5 years in the absence of disease recurrence or unacceptable toxicity.

Patients are followed annually for 5 years and a further 5 years (minimum) off treatment.

Peer Reviewed and Funded by Cancer Research UK. Sponsored by Queen Mary University of London

ACTUAL ACCRUAL: A total of 2,980 patients were accrued for this study over 9 years.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: tamoxifen citrate intervention 2: Anastrozole
Intervention descriptions: intervention 1: Tamoxifen 20mg + Anastrozole placebo intervention 2: Anastrozole 1mg + Tamoxifen placebo

Protocol documents: