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EudraCT Number: 2009-012808-11

Sponsor Protocol Number: MID001

Start Date:

Sponsor Name: Therakind Limited

Full Title: An open label, single dose, pharmacokinetic study of oromucosal midazolam administered to children from 3 months to less than 18 years undergoing routine elective surgery

Medical condition: In the context of the trial, the IMP is to be used as anaesthetic premedication in children undergoing elective routine surgery. (The medical condition for marketing is acute seizures in children ...

Disease:	Version	SOC Term	Classification Code	Term	Level
	9.1		10058073	Anaesthetic premedication	LLT

Population Age: Infants and toddlers, Children, Adolescents, Under 18

Gender: Male, Female

Trial protocol: DE (Completed)

Trial results: (No results available)

EudraCT Number: 2008-004119-36

Sponsor Protocol Number: P05109

Start Date:

Sponsor Name: Schering-Plough Research Institute

Full Title: Proof-of-Concept and Dose Range-Finding Study of SCH 527123 in Subjects with Severe Asthma

Medical condition: Severe Asthma

Disease:	Version	SOC Term	Classification Code	Term	Level
	12.0		10003553	Asthma	LLT

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: DE (Prematurely Ended) HU (Prematurely Ended) GB (Prematurely Ended)

Trial results: View results

EudraCT Number: 2008-008246-20

Sponsor Protocol Number: ABR 25995

Start Date:

Sponsor Name: Radboud University Nijmegen Medical Center, Department of Anaesthesiology, Pain and Palliative Medic

Full Title: Evaluation of the efficacy and safety of sugammadex (Bridion) in children with renal failure.

Medical condition: Sugammadex is a selective relaxant binding agent, which is administered in case of a rocuronium-induced neuromuscular block, during general anaesthesia. The aim of the trial is to investigate the u...

Disease:	Version	SOC Term	Classification Code	Term	Level
	9.1		10038443	Renal failure and impairment	HLT
	9.1		10009119	Chronic renal failure	LLT
	9.1		10014647	End stage renal failure	LLT

Population Age: Children, Adolescents, Under 18

Gender: Male, Female

Trial protocol: NL (Prematurely Ended)

Trial results: (No results available)

EudraCT Number: 2019-003117-33

Sponsor Protocol Number: Pevonedistat-2002

Start Date:

Sponsor Name: Millennium Pharmaceuticals, Inc.

Full Title: A Randomized, Open-label, Controlled, Phase 2 Study of Pevonedistat, Venetoclax, and Azacitidine Versus Venetoclax Plus Azacitidine in Adults With Newly Diagnosed Acute Myeloid Leukemia Who Are Unf...

Medical condition: Acute Myeloid Leukemia (AML)

Disease:	Version	SOC Term	Classification Code	Term	Level
	21.0	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10000886	Acute myeloid leukemia	LLT
	20.1	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10024330	Leukemia acute	LLT
	21.1	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10024348	Leukemia myelogenous	LLT

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: PL (Ongoing) IT (Ongoing) FR (Ongoing)

Trial results: (No results available)

EudraCT Number: 2020-002443-38

Sponsor Protocol Number: C0371006

Start Date:

Sponsor Name: Pfizer Inc., 235 East 42nd Street, New York, NY 10017

Full Title: Phase 3 open-label study to evaluate efficacy, safety, and tolerability of FIX gene transfer with fidanacogene elaparvovec (PF-06838435) in pediatric male participants

Medical condition: moderately severe to severe hemophilia B (FIX:C≤2%)

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	100000004850	10060614	Hemophilia B (Factor IX)	LLT

Population Age: Adolescents, Under 18

Gender: Male

Trial protocol: GB (GB - no longer in EU/EEA)

Trial results: (No results available)

EudraCT Number: 2015-005537-50

Sponsor Protocol Number: 15/BWH/P061

Start Date:

Sponsor Name: Birmingham Women's Hospital

Full Title: High Or Low Dose Syntocinon® for delay in labour: the HOLDS trial

Medical condition: Approximately a third of women become delayed in their first labours and are given intravenous oxytocin in an attempt to increase their uterine contractions, increase spontaneous vaginal birth and ...

Disease:	Version	SOC Term	Classification Code	Term	Level
	21.1	10036585 - Pregnancy, puerperium and perinatal conditions	10000153	Abnormal labour	PT

Population Age: Adolescents, Under 18, Adults

Gender: Female

Trial protocol: GB (GB - no longer in EU/EEA)

Trial results: (No results available)

EudraCT Number: 2006-000441-19

Sponsor Protocol Number: H3E-EW-S098

Start Date:

Sponsor Name: Eli lilly and Company Limited

Full Title: A randomised Phase II study of two chemotherapy regimens, Pemetrexed-Carboplatin, and Gemcitabine-vinorelbine, in Anthracycline and Taxane pretreated Advanced Breast cancer patients.

Medical condition: advanced breast cancer

Disease:	Version	SOC Term	Classification Code	Term	Level
	8.0		10006285		LLT

Population Age: Adults, Elderly

Gender: Female

Trial protocol: DE (Completed) ES (Completed) IT (Completed)

Trial results: View results

EudraCT Number: 2015-003424-31

Sponsor Protocol Number: I4V-MC-JAGA

Start Date:

Sponsor Name: Eli Lilly and Company

Full Title: Treatment of Conditions Expected to Benefit from JAK 1/2 Inhibition: CANDLE, CANDLE-Related Conditions, SAVI, and Severe Juvenile Dermatomyositis

Medical condition: CANDLE, CANDLE-Related Conditions, SAVI, and Severe Juvenile Dermatomyositis, Aicardi-Goutieres Syndrome

Disease:

Version

SOC Term

Classification Code

Term

Level

Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults

Gender: Male, Female

Trial protocol: GB (GB - no longer in EU/EEA)

Trial results: (No results available)

EudraCT Number: 2010-022046-25

Sponsor Protocol Number: Zellweger

Start Date:

Sponsor Name: Department of Pediatric Gastroenterology, Academic Medical Centre

Full Title: Cholic acid treatment in Peroxisomal Biogenesis Disorders (Zellweger spectrum): biochemical and clinical effects.

Medical condition: Peroxisomal biogenesis disorder Synonym: Zellweger spectrum disorder This syndrome encompasses a spectrum of severity in symptoms Previously the disorder was subdivided into three disorders based...

Disease:	Version	SOC Term	Classification Code	Term	Level
	12.1		10053706	Zellweger syndrome	LLT
	12.1		10038275	Refsum's disease	LLT

Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults

Gender: Male, Female

Trial protocol: NL (Ongoing)

Trial results: (No results available)

EudraCT Number: 2018-003863-67

Sponsor Protocol Number: FME_2018_9

Start Date:

Sponsor Name: Fondation Ophtalmologique Adolphe de Rothschild

Full Title: Multicenter randomized controlled trial on the interest of intravitreal injections of anti-VEGF as initial and adjuvant treatment in Coats disease

Medical condition: Coats disease

Disease:

Version

SOC Term

Classification Code

Term

Level

Population Age: Infants and toddlers, Children, Adolescents, Under 18

Gender: Male, Female

Trial protocol: FR (Ongoing)

Trial results: (No results available)

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