ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02265952
Conditions: Homozygous Familial Hypercholesterolemia
Sponsor: Regeneron Pharmaceuticals
Start date: 2015-02-04; Completion date: 2018-07-23
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, single-arm study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia (HoFH).

Detailed description:

Arms: arm 1: Open-label REGN1500
Interventions: intervention 1: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Intervention descriptions: intervention 1: Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.

Protocol documents:
Clinical trial NCT03289234
Conditions: Hepatic Impairment Healthy
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2016-11-16; Completion date: 2018-07-24
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic function

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: MCI-186
Intervention descriptions: intervention 1: 30 mg of edaravone will be administered intravenously over 60 minutes

Protocol documents:
Prot_000.pdf: 







































































































































SAP_001.pdf:
Clinical trial NCT01525550
Conditions: Well-differentiated Pancreatic Neuroendocrine Tumor
Keywords: neuroendocrine tumors adenoma islet cells carcinoma islet cells pancreatic neoplasms angiogenesis inhibitors sunitinib neoplasms carcinoma adenoma
Sponsor: Pfizer
Start date: 2012-06-06; Completion date: 2018-07-26
Enrollment: 106 participants; Allocation: ; Intervention model: 

Brief summary:
The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with unresectable pancreatic neuroendocrine tumors.

Detailed description:
This study is being conducted to meet regulatory post-marketing commitments.

Arms: arm 1: None
Interventions: intervention 1: sunitinib
Intervention descriptions: intervention 1: Sunitinib capsules will be given orally at continuous daily dosing with a starting dose of 37.5 mg. One cycle is equal to 28 days.

Protocol documents:
Clinical trial NCT01104922
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Fractionated Stereotactic Radiosurgery
Sponsor: David A. Clump, MD, PhD
Start date: 2007-12-26; Completion date: 2018-07-26
Enrollment: 48 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial examines survival and toxicity in previously irradiated patients with squamous cell carcinoma of the head and neck (SCCHN) treated with radiosurgery and cetuximab and to evaluate the acute and late toxicities associated with the above therapy.

Detailed description:
Squamous cell carcinoma of the head and neck is the sixth most common malignancy worldwide with approximately 500,000 cases worldwide yearly. There were an estimated 39,250 new cases and 11,000 deaths in the United States in 2005 (Jemal 2005, Spitz MR). Despite major improvements in the treatment of SCCHN in recent years which include the introduction of concurrent chemoradiotherapy as an effective primary or postoperative therapy, the five-year survival rate for patients with SCCHN in the United States and other developed countries remains poor as nearly 50-60% of these patients will die as a direct result of recurrent locoregional disease. This study aims to determine the 1-year progression-free survival (PFS) of previously irradiated patients with squamous cell carcinoma of the head and neck (SCCHN) treated with radiosurgery and cetuximab and to evaluate the acute and late toxicities associated with the therapy.

Arms: arm 1: None
Interventions: intervention 1: Cetuximab intervention 2: Stereotactic radiosurgery
Intervention descriptions: intervention 1: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: \* Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) \* Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. intervention 2: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)

Protocol documents:
Clinical trial NCT01835470
Conditions: Juvenile Idiopathic Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2013-08-09; Completion date: 2018-07-30
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy of Abatacept after intravenous administration in Japanese children and adolescents with active juvenile idiopathic arthritis who have a history of an inadequate response or intolerance to Methotrexate or biologics

Detailed description:

Arms: arm 1: Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
Interventions: intervention 1: Abatacept
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01909479
Conditions: Adult Growth Hormone Deficiency
Sponsor: OPKO Health, Inc.
Start date: 2013-06-01; Completion date: 2018-08-01
Enrollment: 202 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once weekly injection of modified hGH (MOD-4023).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MOD-4023 intervention 2: Placebo
Intervention descriptions: intervention 1: Individualized once weekly dose of MOD-4023 intervention 2: Once weekly administration of placebo

Protocol documents:
Clinical trial NCT02018627
Conditions: Type 1 Diabetes
Keywords: bionic pancreas artificial pancreas insulin glucagon clamp
Sponsor: Steven J. Russell, MD, PhD
Start date: 2014-04-01; Completion date: 2018-08-02
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will test the hypothesis that micro-doses of Xerisol Glucagon (Xeris Pharmaceuticals) will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of Glucagon for Injection (Eli Lilly).

Detailed description:
This study will test the hypothesis that micro-doses of a new formulation of stable glucagon, Xerisol Glucagon (Xeris Pharmaceuticals), will be non-inferior by pharmacokinetic and pharmacodynamic criteria vs. micro-doses of a freshly reconstituted formulation of glucagon that has poor stability in solution, Glucagon for Injection (Eli Lilly).

Arms: arm 1: Xeris glucagon 50 micrograms, subcutaneous injection arm 2: Lilly glucagon 30 micrograms, subcutaneous injection
Interventions: intervention 1: Xeris glucagon intervention 2: Lilly glucagon
Intervention descriptions: intervention 1: The subject is given an injection of xeris glucagon intervention 2: The subject is given an injection of lilly glucagon

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT04481750
Conditions: Healthy Adult Subjects
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2018-03-20; Completion date: 2018-08-03
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the pharmacokinetics safety, and tolerability of single and multiple doses of edaravone solution and suspension in healthy adult males

Detailed description:

Arms: arm 1: Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo. arm 2: Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo. arm 3: Healthy Japanese male subjects receive doses of MT-1186 or matching placebo. arm 4: Healthy Japanese male subjects receive doses of MT-1186 or matching placebo. arm 5: Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo. arm 6: Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo. arm 7: Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo. arm 8: Healthy Caucasian male subjects receive a single dose of MT-1186 or matching placebo. arm 9: Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo. arm 10: Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo
Interventions: intervention 1: MT-1186 intervention 2: MT-1186-matching placebo
Intervention descriptions: intervention 1: Solution or suspension intervention 2: Solution or suspension

Protocol documents:
Prot_000.pdf: 































































































































































SAP_001.pdf:
Clinical trial NCT02916706
Conditions: Type 2 Diabetes Mellitus
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2016-09-01; Completion date: 2018-08-14
Enrollment: 254 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
This study is designed as a prospective, multi-centre, parallel group, double-blind randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of MP-513 (Teneligliptin).

Detailed description:

Arms: arm 1: Teneligliptin (20mg once daily) for 24 weeks arm 2: Placebo for 24 weeks
Interventions: intervention 1: Teneligliptin 20mg intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_000.pdf: 















































































































SAP_001.pdf:
Clinical trial NCT02686164
Conditions: Tumors
Keywords: Lenvatinib Lenvima E7080 Phase 1 Solid tumors Midazolam CYP3A4
Sponsor: Eisai Inc.
Start date: 2016-04-18; Completion date: 2018-08-16
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, open-label, non-randomized Phase 1 study in participants with advanced solid tumors, excluding hepatocellular carcinoma (HCC), that have progressed after treatment with approved therapies, or for which there are no standard therapies available. The study will also include participants with radioiodine-refractory differentiated thyroid cancer (RR-DTC). Its primary intent is to determine the effect of lenvatinib on CYP3A4 activity as well as to assess the safety and activity of lenvatinib in these participants. The study will be conducted in the following 3 phases: Pretreatment Phase, Treatment Phase, and Extension Phase.

Detailed description:

Arms: arm 1: Participants with histologically confirmed unresectable or refractory solid tumors.
Interventions: intervention 1: Lenvatinib intervention 2: Midazolam
Intervention descriptions: intervention 1: Lenvatinib 24 mg (as one 4 mg and two 10 mg capsules) will be administered orally once daily with 240 mL (8 fluid oz) of water each morning, starting on Cycle 1 Day 1, in 28-day cycles. intervention 2: Midazolam syrup 4 mg will be administered orally after an overnight fast on Cycle 1 Day -3 and concurrently with lenvatinib on Day 1 and Day 14 of Cycle 1. Participants will have to remain fasting for 2 hours after each dose of midazolam.

Protocol documents:
Clinical trial NCT02478632
Conditions: HIV Infections
Keywords: tenofovir disoproxil fumarate dolutegravir plus rilpivirine two-drug regimen bone mineral density dual energy X-ray absorptiometry (DEXA) Human Immunodeficiency Virus-1 nucleoside reverse transcriptase inhibitor -sparing regimen integrase inhibitor
Sponsor: ViiV Healthcare
Start date: 2015-06-12; Completion date: 2018-08-17
Enrollment: 102 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate any change from baseline in bone mineral density (BMD) in subjects following the switch from a triple antiretroviral therapy (ART) regimen containing Tenofovir disoproxil fumarate (TDF) to the nucleoside reverse transcriptase inhibitor (NRTI) - sparing two - drug regimen of dolutegravir (DTG) + rilpivirine (RPV) in subjects participating in the parent studies 201636 and 201637 (SWORD-1 and SWORD-2).

This open-label, parallel group, study is a sub-study which will recruit subjects who are receiving ART regimens which include TDF at the time of randomization to receive treatment in one of two identical parent studies 201636 and 201637 (SWORD-1 and SWORD-2). These are Phase III, randomised, open-label, multicentre, parallel-group, non-inferiority studies evaluating the efficacy, safety, and tolerability of switching to DTG plus RPV from current integrase inhibitor (INI)-, non NNRTI-, or protease inhibitor (PI)-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed, having HIV-1 ribonucleic acid (RNA) levels \<50 copies per millilitre (c/mL). Randomisation in the parent studies will be stratified by baseline third agent class (INI, NNRTI, or PI), age group (\< or =\>50 years old) and participation in this Dual energy X-ray absorptiometry (DEXA) sub-study, therefore there will also be balance across the treatment arms in this sub-study both overall and with respect to baseline third agent class and age at entry.

The study population will include approximately 75 evaluable subjects recruited from the Early Switch DTG + RPV treatment group of the parent studies 201636 and 201637, and approximately 75 evaluable subjects from the Late Switch group who continue their current antiretroviral therapy (CAR) through to Week 52 across both the 201636 and 201637 (SWORD-1 and SWORD-2) studies. Subjects participating in study 202094 will have DEXA scans performed at Day 1 and at study Weeks 48, 100 and 148 in parallel with the corresponding scheduled visits in the parent studies.

Detailed description:

Arms: arm 1: Participants do not receive study medication in this study 202094. Participants group carried over from the parent study 201636 (SWORD-1) or 201637 (SWORD-2). arm 2: Participants do not receive study medication in this study 202094. Participants group carried over from the parent study 201636 (SWORD-1) or 201637 (SWORD-2)
Interventions: intervention 1: Subjects do not receive study medication in this study 202094
Intervention descriptions: intervention 1: Participants do not receive study medication in this study 202094.

Protocol documents:
Clinical trial NCT00759642
Conditions: Metastatic Breast Cancer
Keywords: breast cancer hormone receptor positive HER-2 negative
Sponsor: University of Kansas Medical Center
Start date: 2009-03-01; Completion date: 2018-08-20
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hormone receptor positive breast cancer is the most common type of breast cancer, comprising 70-80% of all breast cancers. Endocrine therapy is the main type of initial treatment for patients with your type of breast cancer. Endocrine therapy is treatment that tries to remove, or block certain hormones from binding to the cancer cells and thus slow or stop the growth of cancer. Although most patients with your type of breast cancer respond initially to endocrine therapies, it can lose its effectiveness. New therapies for this type of cancer are needed.

Detailed description:
Endocrine therapy forms the backbone of treatment for both early stage and advanced stage hormone receptor positive breast cancer. Although most patients with advanced estrogen receptor positive metastatic disease respond initially to endocrine therapies, this response is short lived. New therapies able to provide additional benefit to patients with hormone receptor positive, endocrine-resistant, advanced metastatic breast cancer are required. This study proposes to add lapatinib to endocrine therapy to treat hormone receptor positive HER-2 negative metastatic breast cancer patients.

Arms: arm 1: lapatinib
Interventions: intervention 1: lapatinib
Intervention descriptions: intervention 1: lapatinib 1500 mg PO daily

Protocol documents:
Clinical trial NCT02289833
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2014-12-15; Completion date: 2018-08-20
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 2, multicenter study designed to evaluate the efficacy and safety of trastuzumab emtansine administered as a single-agent in participants with HER2-positive (HER2 IHC 2+ or HER2 IHC 3+) advanced or metastatic NSCLC. Participants will be treated with trastuzumab emtansine administered intravenously at a dose of 3.6 milligrams per kilogram (mg/kg) on Day 1 of 21-day cycles until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor, whichever occurs first.

Detailed description:

Arms: arm 1: Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine. arm 2: Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
Interventions: intervention 1: Trastuzumab Emtansine
Intervention descriptions: intervention 1: Trastuzumab emtansine will be administered intravenously (IV) at a dose of 3.6 mg/kg on Day 1 of every 21-day cycle until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the sponsor, whichever occurs first.

Protocol documents:
Clinical trial NCT02226965
Conditions: Lymphoma, Diffuse Large B-Cell
Keywords: PNT2258 DLBCL Diffuse Large B-cell Lymphoma NHL Non-Hodgkin's Lymphoma Lymphoma
Sponsor: Sierra Oncology LLC - a GSK company
Start date: 2014-12-01; Completion date: 2018-08-22
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a multi-center, nonrandomized, open label, phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma.

Detailed description:

Arms: arm 1: PNT2258 will be administered at 120 mg/m2 on days 1-5 of a 21-day cycle. Treatment may continue unless there is disease progression or the occurrence of unacceptable toxicity for a total of 8 "induction" cycles of therapy. Subjects with CR/CMR, PR/PMR or SD/NMR at the end-of-cycle 8 scan then receive ongoing PNT2258 therapy at a dose of 100 mg/m2 on days 1-4 of a 28 day cycle until progressive disease, the occurrence of unacceptable toxicity, non-compliance, voluntary withdrawal or if in the opinion of the investigator the subject is no longer benefiting from exposure to PNT2258.
Interventions: intervention 1: PNT2258
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT03255629
Conditions: Post-bariatric Hypoglycemia
Sponsor: Joslin Diabetes Center
Start date: 2017-09-19; Completion date: 2018-08-22
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To assess the efficacy of a closed loop glucagon system to prevent and treat hypoglycemia occurring in patients with Post-Bariatric Hypoglycemia (PBH) in response to meals and exercise.

Detailed description:
A control system for sensor-guided delivery was previously developed and tested in a Proof-of-Concept (POC) study in a clinical research setting during 9 mixed meal tolerance tests in 8 unique patients with severe hypoglycemia following bariatric surgery. This optimized algorithm will now be implemented to deliver stable glucagon in a closed-loop system.

A randomized, placebo-controlled, masked trial will be conducted to assess the efficacy of the closed loop system to prevent and treat hypoglycemia occurring in patients with PBH in response to meals (part 1). Part 2 will test whether the closed loop system can also prevent and treat hypoglycemia in patients with PBH in response to exercise. A manufacturing program from our collaborating team at Xeris Pharmaceuticals will continue to produce supplies of glucagon for the clinical trial in a current good manufacturing practice (cGMP) facility, with continued shelf-life stability testing.

Arms: arm 1: Each subject will have two mixed meal tolerance tests performed. Each will be randomized to receive either glucagon or matched placebo during the first testing session. A participant could receive 2 doses of the study drug or placebo at each study visit. The opposite treatment will be given during the second testing session after a 1-2 week washout period. Both participants and the study team will be blinded to the intervention being used during each session. arm 2: Each subject will have two mixed meal tolerance tests performed. Each will be randomized to receive either glucagon or matched placebo during the first testing session. A participant could receive 2 doses of the study drug or placebo at each study visit. The opposite treatment will be given during the second testing session after a 1-2 week washout period. Both participants and the study team will be blinded to the intervention being used during each session.
Interventions: intervention 1: glucagon intervention 2: Closed loop glucagon pump
Intervention descriptions: intervention 1: novel, stable non-aqueous glucagon formulation provided by Xeris Pharmaceuticals intervention 2: a novel closed-loop glucagon system (CLG) incorporating a novel, stable non-aqueous glucagon formulation together with an infusion pump system (Omnipod) guided by real-time continuous glucose monitoring (Dexcom) that is triggered by a hypoglycemia alert algorithm.

Protocol documents:
Prot_SAP_000.pdf: