ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00529035
Conditions: Graft Versus Host Disease
Keywords: Chronic GVHD Steroid refractory GVHD allogeneic stem cell transplantation
Sponsor: Dana-Farber Cancer Institute
Start date: 2007-08-01; Completion date: 2020-05-27
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine the safety of IL-2 and the highest dose of this drug that can be given safely to people with chronic graft versus host disease (GVHD). Chronic GVHD is a medical condition that may occur after patients receive a bone marrow, stem cell or cord blood transplant. The donor's immune system may recognize their body (the host) as foreign and attempt to "reject" it. Traditional standard therapy to treat chronic GVHD is prednisone (steroids). Treatment options are limited, and it is thought that IL-2 may help to control chronic GVHD.

Detailed description:
* IL-2 will be given daily through an injection under the skin for a period of 8 weeks. To determine the highest safest dose of IL-2, the dose participants receive will increase as lower doses are determined to be safe. There will be three dose levels.
* Participants will be seen periodically while they are receiving IL-2. Physical exams and blood tests will be performed weekly for the first two weeks and then every other week until week 8.

Arms: arm 1: Interleukin-2 (IL-2) will be given daily through an injection under the skin for a period of 8 weeks. To determine the highest safest dose of IL-2, the dose participants receive will increase as lower doses are determined to be safe. There will be three dose levels:

Dose Level -A 0.3 x 106 (IU/m2/d) Dose Level -B 1 x 106 (IU/m2/d) Dose Level-C 3 x 106 (IU/m2/d)
Interventions: intervention 1: Interleukin-2
Intervention descriptions: intervention 1: Dose will vary depending upon when participant enters the trial: Given as a daily injection under the skin for 8 weeks.

Protocol documents:
Clinical trial NCT01610336
Conditions: Non-small Cell Lung Cancer
Keywords: EGFR c-MET Lung cancer Gefitinib Erlotinib Non-small cell lung cancer (NSCLC) lung adenocarcinoma large-cell lung carcinoma
Sponsor: Novartis Pharmaceuticals
Start date: 2012-04-05; Completion date: 2020-05-27
Enrollment: 161 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study assessed the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that were known to have dysregulation of the c-MET pathway and who had failed after benefiting on a prior treatment with either gefitinib or erlotinib.

Detailed description:
The Phase Ib dose escalation part was aimed at the determination of the MTD/RP2D of capmatinib in combination with 250 mg gefitinib in patients with NSCLC patients with epidermal growth factor receptor (EGFR) mutation and cMET dysregulation and showing disease progression following EGFR tyrosine-kinase inhibitor (EGFR TKI) therapy. Dose escalation started with a dose of 100 mg/day to a maximum of 1200 mg/day, as capsule or tablet formulation. Successive cohorts of patients were to receive increasing doses of capmatinib in combination with a 250 mg once daily (qd) dose of gefitinib until the MTD/RP2D of capmatinib had been determined. The Phase II dose expansion part consisted of 400 mg capmatinib twice daily (bid), as either capsules or tablets, in combination with 250 mg gefitinib.

Arms: arm 1: cap=capsule; QD=once daily arm 2: cap=capsule; QD=once daily arm 3: cap=capsule; QD=once daily arm 4: cap=capsule; QD=once daily arm 5: cap=capsule; BID=twice daily arm 6: cap=capsule; BID=twice daily arm 7: cap=capsule; BID=twice daily arm 8: tab=tablet; BID=twice daily arm 9: tab=tablet; BID=twice daily arm 10: cap=capsule; BID=twice daily arm 11: tab=tablet; BID=twice daily
Interventions: intervention 1: INC280 intervention 2: Gefitinib
Intervention descriptions: intervention 1: During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose. intervention 2: Gefitinib 250 mg taken once daily

Protocol documents:
Clinical trial NCT01618695
Conditions: Partial-onset Seizures
Keywords: Partial-onset Seizures partial seizures seizure epilepsy
Sponsor: Eisai Co., Ltd.
Start date: 2012-05-15; Completion date: 2020-05-28
Enrollment: 940 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to confirm the efficacy and safety of perampanel compared to placebo in patients with refractory partial-onset seizures

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Perampanel intervention 2: Placebo
Intervention descriptions: intervention 1: Core study: 4 milligram (mg) group- Week 0 Once daily 2 milligram per day (mg/day), Week 1 to Week 18 Once daily 4 mg/day; 8 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 to Week 18 Once daily 8 mg/day; 12 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 Once daily 8 mg/day, Week 4 Once daily 10 mg/day, Week 5 to Week 18 Once daily 12 mg/day.

Extension study: 4 mg group- Week 19 to Week 22 Once daily 4 mg/day, Week 23 Once daily 6 mg/day, Week 24 Once daily 8 mg/day, Week 25 Once daily 10 mg/day, Week 26 to Week 75 or more Once daily 12 mg/day; 8 mg group- Week 19 to Week 22 Once daily 8 mg/day, Week 23 Once daily 10 mg/day, Week 24 to Week 75 or more Once daily 12 mg/day; 12 mg group- Week 19 to Week 75 or more Once daily 12 mg/day. intervention 2: Core study: Week 0 to Week 18 Once daily placebo.

Extension study:

Week 19 to Week 22 Once daily placebo, Week 23 Once daily perampanel 2 mg/day, Week 24 Once daily perampanel 4 mg/day, Week 25 Once daily perampanel 6 mg/day, Week 26 Once daily perampanel 8 mg/day, Week 27 Once daily perampanel 10 mg/day, Week 28 to Week 75 or more Once daily perampanel 12 mg/day.

Protocol documents:
Clinical trial NCT01338415
Conditions: Pulmonary Arterial Hypertension
Keywords: pediatric pulmonary arterial hypertension bosentan Tracleer
Sponsor: Actelion
Start date: 2011-03-08; Completion date: 2020-05-29
Enrollment: 58 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).

Detailed description:

Arms: arm 1: Patients who received 2 mg/kg bosentan twcie daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study arm 2: Patients who received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
Interventions: intervention 1: Bosentan
Intervention descriptions: intervention 1: Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day

Protocol documents:
Clinical trial NCT03323164
Conditions: Glaucoma; Drugs Normal Tension Glaucoma Primary Open-angle Glaucoma
Sponsor: Wills Eye
Start date: 2017-07-10; Completion date: 2020-05-30
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the possible acute changes in peripapillary blood flow after instillation of antiglaucoma medications in patients with primary open angle glaucoma (POAG), normal tension glaucoma (NTG), or ocular hypertension (OHTN) using Optical Coherence Tomography (OCT) angiography.

Detailed description:
Reduction of intraocular pressure (IOP) with topical antihypertensive medications is the mainstay of initial treatment in patients with OHTN, POAG, and NTG. Many patients, however, continue to experience disease progression despite IOP reduction. Alternative mechanisms of neurodegeneration, including vascular dysregulation and structural susceptibility of the lamina cribrosa, have been proposed as important mechanisms in progression, particularly in cases of NTG.

Prior studies have also found decreased calculated mean ocular perfusion with the use of timolol compared to other antiglaucoma medications in patients with normal tension glaucoma. Visual field deterioration has also been shown to be associated with systemic nocturnal arterial hypotension in patients with NTG, POAG, and after anterior ischemic optic neuropathy. The use of ophthalmic topical beta-blockers has been shown to lower nocturnal diastolic blood pressure and heart rate. Thus, topical beta blockers are often avoided in the treatment of NTG due to the potential risk of reduced optic nerve head perfusion

Studies evaluating optic nerve head (ONH) perfusion are limited. Earlier studies evaluated indirect measurements, such as calculated mean ocular perfusion pressure or systemic hypotension, as indications of optic nerve hypoperfusion. Direct measurements of ocular perfusion have been attempted using retrobulbar color Doppler imaging, which demonstrated decreased short posterior ciliary artery flow velocity in patients with glaucomatous visual field progression. This technique, however, has yielded inconsistent results in other studies, and is only capable of detecting gross changes to ocular blood flow.

Optical Coherence Tomography Angiography (OCTA) is a novel technique first introduced in 2014 using a custom swept-source OCT system.No studies currently exist to evaluate the effects of antiglaucoma medications on peripapillary blood flow using OCTA.

Arms: arm 1: Timolol maleate 0.5% ophthalmic solution Instillation of one drop in each eye, once. arm 2: Brimonidine tartrate 0.2% Instillation of one drop in each eye, once.
Interventions: intervention 1: Timolol Maleate intervention 2: Brimonidine Tartrate
Intervention descriptions: intervention 1: Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation. intervention 2: Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT03031938
Conditions: Osteoarthritis Cancer Pain Recurrent Low Back Pain
Keywords: Exposure in utero in tanezumab program
Sponsor: Pfizer
Start date: 2017-11-03; Completion date: 2020-06-04
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A4091065 is a multicenter, prospective, cohort study with enhance physical an neurodevelopmental surveillance to characterize the outcomes related to the development of infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or comparator via maternal exposure or in utero in any tanezumb study.

Detailed description:
A4091065 is a long term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063

Arms: arm 1: Long term observational study of subjects from tanezumab parent study
Interventions: intervention 1: Investigational medical product (IMP) administered in parent study
Intervention descriptions: intervention 1: IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study

Protocol documents:
Prot_000.pdf: 























































































SAP_001.pdf:
Clinical trial NCT00444535
Conditions: Neoplasms, Breast
Keywords: VEGF Tyrosine kinase ErbB2 Her2-neu metastatic breast cancer EGFR ErbB1 bevacizumab lapatinib breast carcinoma breast cancer breast lump breast cancer positive for human epidermal growth factor receptor 2 (HER2) HER2 positive metastatic breast cancer breast cancer progression estrogen-receptor (ER) positive(+) breast cancer Paget's disease
Sponsor: Novartis Pharmaceuticals
Start date: 2007-02-27; Completion date: 2020-06-19
Enrollment: 52 participants; Allocation: NA; Intervention model: 

Brief summary:
This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.

Detailed description:

Arms: arm 1: 1500 mg oral lapatinib (once daily) plus 10 mg/kg intravenous bevacizumab (every two weeks)
Interventions: intervention 1: lapatinib intervention 2: bevacizumab
Intervention descriptions: intervention 1: 1500 mg oral lapatinib (once daily) intervention 2: 10 mg/kg intravenous bevacizumab (every two weeks)

Protocol documents:
Clinical trial NCT01024920
Conditions: Carcinoma, Renal Cell
Sponsor: Boehringer Ingelheim
Start date: 2009-12-16; Completion date: 2020-06-19
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Compare safety and efficacy of BIBF 1120 versus sunitinib in patients with advanced RCC and to investigate the effects of BIBF 1120 on the heart rate (HR) corrected QT interval (QTcF).

Detailed description:

Arms: arm 1: Non-marketed substance: Twice daily oral doses of 200mg BIBF 1120 given continuously. arm 2: Marketed substance: Once a day oral doses of 50mg sunitinib given in repeated 6 week cycles: 4 weeks active, 2 weeks rest.
Interventions: intervention 1: BIBF 1120 intervention 2: sunitinib
Intervention descriptions: intervention 1: VEGF inhibitor intervention 2: VEGF inhibitor

Protocol documents:
Clinical trial NCT02707523
Conditions: Respiratory Syncytial Virus
Keywords: RSV respiratory support ICU Azithromycin
Sponsor: University of Alabama at Birmingham
Start date: 2016-01-01; Completion date: 2020-06-20
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This randomized, double-blind, placebo-controlled phase 2 trial will be conducted at a single tertiary pediatric intensive care unit (PICU). The study will include children with RSV infection who were admitted to the pediatric intensive care unit and require respiratory support via positive pressure ventilation (invasive and noninvasive).

Detailed description:
Eligible participants include all children admitted to the PICU at Children's of Alabama with a diagnosis of RSV infection and requiring positive pressure ventilation, invasive or noninvasive, including bilevel positive airway pressure (BiPAP) or high flow nasal cannula (HFNC) oxygen (ie, \>1 L/kg/min of flow, with 5 L/min flow for children weighing \<5 kg). During hospitalization, all patients will be treated according to the American Academy of Pediatrics guidelines for the management of bronchiolitis, primarily supportive care. Participants will then be randomized according to a permuted-block design to receive either placebo (saline) or AZM (Fresenius Kabi) at 10mg/kg/d (ie, standard dose) or 20mg/kg/d (ie, high dose) intravenously every 24 hours for 3 days. All biologic samples collected will be analyzed in the PI's lab at the University of Alabama at Birmingham. Drug pharmacokinetics will be performed at the Pharmaceutical Sciences Research Institute of Samford University, Birmingham, AL.

Arms: arm 1: Placebo controlled (normal saline) daily for 3 days arm 2: 10 mg/kg IV Azithromycin daily for 3 days arm 3: 20 mg/kg IV Azithromycin daily for 3 days
Interventions: intervention 1: Azithromycin 10 mg intervention 2: Azithromycin 20mg intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT00508274
Conditions: Neoplasms, Breast
Keywords: Advanced Metastatic Breast Cancer HER2 positive HER2+ breast cancer lapatinib TYVERB TYKERB Capecitabine
Sponsor: Novartis Pharmaceuticals
Start date: 2007-07-18; Completion date: 2020-07-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Local study in China and Hong Kong to evaluate safety and efficacy in lapatinib + capecitabine in women with Human epidermal growth factor receptor 2 (HER2) positive advanced or metastatic breast cancer.

Detailed description:
The Primary objective of the study was to evaluate the overall clinical benefit response (CBR) rate.

This was a single arm, open-label, multi-center study of lapatinib plus capecitabine in women from mainland China and Hong Kong who had advanced or metastatic breast cancer that progressed on prior chemotherapies with or without trastuzumab.

Participants received study treatment until disease progression, unacceptable toxicity, or withdrawal for any other reasons.

Arms: arm 1: daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000mg/m2/day on days1-14 every 21 days)
Interventions: intervention 1: lapatinib intervention 2: capecitabine
Intervention descriptions: intervention 1: Lapatinib ditosylate monohydrate tablets, 250 mg, are oval, biconvex, orange, film-coated tablets taken orally. intervention 2: Capecitabine is supplied as a biconvex, oblong, light peach and peach colored, film-coated tablets for oral administration.

Protocol documents:
Clinical trial NCT02097732
Conditions: Metastatic Melanoma Brain Metastases
Keywords: Metastatic melanoma Brain metastases Radiation therapy Immune therapy
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2014-04-01; Completion date: 2020-07-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to test the efficacy of using standard immune therapy for melanoma prior to stereotactic radiosurgery (ipilimumab induction), as compared to stereotactic radiosurgery followed by immune therapy. The study's hypothesis is that ipilimumab induction is as good as or better than controlling brain metastases as compared to stereotactic radiosurgery followed by immune therapy.

Detailed description:
This is a randomized Phase II selection study investigating the use of ipilimumab induction prior to stereotactic radiosurgery (SRS), versus no induction, for melanoma brain metastases. Participants will be randomized to Arm A "Induction" (two doses of ipilimumab prior to SRS, two doses of ipilimumab after SRS) versus Arm B "No induction" (SRS first, followed by 4 doses of ipilimumab). Participants will undergo multiple dynamic contrast-enhanced MRIs of the brain and submit blood samples for immune testing.

Arms: arm 1: Participants will undergo stereotactic radiosurgery (SRS) followed 2-3 weeks later by ipilimumab, which is given once every 3 weeks for a total of 4 doses. arm 2: Patients will receive 2 doses of ipilimumab, which is given once every 3 weeks, prior to stereotactic radiosurgery (SRS), followed by 2 more doses of ipilimumab, for a total of 4 doses.
Interventions: intervention 1: Ipilimumab intervention 2: Stereotactic Radiosurgery
Intervention descriptions: intervention 1: Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses. intervention 2: Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours.

Protocol documents:
Clinical trial NCT02904226
Conditions: Cancer
Keywords: ICOS ICOS agonist monoclonal antibody JTX-2011 Anti-PD-1 Nivolumab ICONIC Immunotherapy Immuno-oncology Cancer Solid Tumor Dose Escalation Dose Expansion Anti-CTLA-4 Ipilimumab Pembrolizumab
Sponsor: Jounce Therapeutics, Inc.
Start date: 2016-08-01; Completion date: 2020-07-01
Enrollment: 242 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

Detailed description:
JTX-2011 is an agonist monoclonal antibody that specifically binds to the Inducible CO-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, PK, PD, and preliminary efficacy of the ICOS agonist monoclonal antibody JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent and the combination therapies, followed by an expansion phase in specified tumor types for single agent and the combination therapies.

Arms: arm 1: Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion arm 2: Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion arm 3: Phase 2 expansion of JTX-2011 by IV infusion arm 4: Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion arm 5: Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion arm 6: Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion arm 7: Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion arm 8: Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
Interventions: intervention 1: JTX-2011 intervention 2: Nivolumab intervention 3: Ipilimumab intervention 4: Pembrolizumab
Intervention descriptions: intervention 1: Specified dose on specified days intervention 2: Specified dose on specified days intervention 3: Specified dose on specified days intervention 4: Specified dose on specified days

Protocol documents:
Prot_000.pdf: 





















































































































































































































































































































SAP_001.pdf:
Clinical trial NCT03809039
Conditions: Healthy
Sponsor: Mitsubishi Tanabe Pharma America Inc.
Start date: 2019-01-15; Completion date: 2020-07-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MT-6345 intervention 2: MT-6345 Placebo
Intervention descriptions: intervention 1: MT-6345 intervention 2: MT-6345 Placebo

Protocol documents:
Prot_000.pdf: 





























































































































































































SAP_001.pdf:
Clinical trial NCT02207530
Conditions: Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck
Keywords: Head and neck cancer; SCCHN
Sponsor: AstraZeneca
Start date: 2014-10-23; Completion date: 2020-07-06
Enrollment: 112 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR

Detailed description:
This is a phase II, multi-center, single-arm, global study of MEDI4736 monotherapy in patients with PD-L1 positive recurrent or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN), who have progressed during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic disease that must have contained a platinum agent.

Arms: arm 1: MEDI4736 monotherapy
Interventions: intervention 1: MEDI4736
Intervention descriptions: intervention 1: MEDI4736 monotherapy

Protocol documents: