louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01464866: Effect of Nutritional Supplementation on Pediatric Burn Patients
Official title: Effect of Nutritional Supplementation on Pediatric Burn Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Burns
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2011-11-04
Enrollment: 116
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the effect of nutrition supplementation on blood protein levels in pediatric burn patients.


Eligibility criteria: Inclusion Criteria:

1. 1-10 years of age
2. Hospital admission within 24 hours post-burn
3. At least 15% TBSA burned to at least 2nd degree and no more than 5% TBSA 4th degree or higher
4. Capable of exclusive oral feeding within 3 days of hospitalization
5. Expected to be hospitalized at least 14 days

Exclusion Criteria:

1. History diabetes or stress-induced hyperglycemia
2. Artificial ventilation
3. Requires parenteral or enteral feeding
4. IV albumin
5. Drug that affects metabolism
6. Receiving Dialysis
7. Acutely impacted or constipated
8. Consumes non-study nutritional supplement
9. Allergy or intolerance to any study product ingredient
10. Participating in non-Abbott approved concomitant trial

Primary outcomes:
measure: prealbumin
timeFrame: Change between Baseline and Day 14
Secondary outcomes:
measure: Preablumin
timeFrame: Change between Baseline and Day 7
measure: C Reactive Protein (CRP)
timeFrame: Between baseline and Day 7
measure: C Reactive Protein
timeFrame: Between baseline and Day 14
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Children City Clinical Hospital #9
city: Izhevsk
country: Russian Federation
facility: First Republic Clinical Hospital of Ministry of Healthcare of Udmurtia Republic
city: Kazan
country: Russian Federation
facility: Children's Republican Clinical Hospital of Ministry of Healthcare of Tatarstan Republic
city: Kemerovo
country: Russian Federation
facility: City Clinical Hospital #2
city: Moscow
country: Russian Federation
facility: Children's City Hospital #9
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Research Institute of Traumatology & Orthopedics of Federal Agency of High Technology Medical Care
city: Rostov-na-Donu
country: Russian Federation
facility: City Hospital #20
city: Saratov
country: Russian Federation
facility: City Clinical Hospital #7
city: St. Petersburg
country: Russian Federation
facility: Children's City Hospital #1
Study officials:
affiliation: Abbott Nutrition
name: Jennifer Williams, MPH
role: STUDY_CHAIR
References:
Clinical trial NCT01796366: A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes
Official title: A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0123-0000-0338 (insulin 338) in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male subject, or female subject of no childbearing potential, if surgically sterilized (i.e. tubal ligation, bilateral oopherectomies (removal of both ovaries and both fallopian tubes) or hysterectomised) for at least 3 months or if postmenopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by follicle stimulating hormone (FSH) levels above 40 U/L)
* Body mass index (BMI) between 20.0 and 35.0 kg/m\^2 (both inclusive)
* Type 2 diabetes mellitus (as diagnosed clinically) for 12 months or more

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the Investigator
* Any chronic disorder or severe disease which in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol

Primary outcomes:
measure: Number of treatment emergent adverse events
timeFrame: As recorded from first trial product administration (Day 1) and until Sub-visit 2A (Day 12) of the dosing visit
Secondary outcomes:
measure: Area under the serum insulin concentration-time curve
timeFrame: During one dosing interval (0-24 hours) at steady-state (Day 10)
measure: Area under the glucose infusion rate-time curve
timeFrame: During one dosing interval (0-24 hours) at steady state (Day 10)
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01132066: Transcranial Direct Current Stimulation (TDCS) for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Stroke
Official title: Pilot Study of Transcranial Direct Current Stimulation for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dysphagia
Keywords: swallowing
stroke
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the research study is to investigate the effect of a brain stimulation technique called Transcranial Direct Current Stimulation (TDCS) in improving swallowing functions in subjects who develop dysphagia after a unilateral hemispheric infarction.


Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke
* Between 24-168 hours after onset
* Moderate to severe dysphagia based on swallowing assessment

Exclusion Criteria:

* Preexisting swallowing impairment
* Intracerebral hemorrhage
* Pacemaker of other electrically sensitive device

Primary outcomes:
measure: Dysphagia Outcome and Severity Scale Score (DOSS)
timeFrame: 5 days after study enrollment
Secondary outcomes:
measure: Incidence of seizure
timeFrame: 5 days after study enrollment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Sandeep Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar S, Wagner CW, Frayne C, Zhu L, Selim M, Feng W, Schlaug G. Noninvasive brain stimulation may improve stroke-related dysphagia: a pilot study. Stroke. 2011 Apr;42(4):1035-40. doi: 10.1161/STROKEAHA.110.602128. Epub 2011 Mar 24.
Clinical trial NCT03030066: Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas
Official title: A Phase 1 Study of DS-1001b in Patients With IDH1 Mutated Gliomas
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Glioma
Keywords: DS-1001b
IDH1 mutation
Developmental Phase I
Glioma
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2017-01-24
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132 mutations.


Eligibility criteria: Inclusion Criteria:

1. Has histologically confirmed glioma with an IDH1-R132 mutation
2. Has disease that has recurred or progressed following standard treatment including radiotherapy
3. Has measurable lesion(s) as per RANO criteria
4. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion Criteria:

1. Has significant symptoms of increased intracranial pressure
2. Has another active neoplasm
3. Has active infection requiring systemic treatment
4. Has a history of severe cardiac disease
5. Has had prior treatment with any inhibitor targeting mutant IDH1
6. Has had investigational drug treatment within 4 weeks prior to the first dose of study treatment
7. Is a pregnant or lactating female

Primary outcomes:
measure: Percentage of participants with dose limiting toxicities
timeFrame: 21 days
Secondary outcomes:
measure: Percentage of participants experiencing an adverse event (AE)
timeFrame: up to 36 months
measure: Area under the concentration curve (AUC) for DS-1001b
timeFrame: up to 36 months
measure: Maximum plasma concentration (Cmax) for DS-1001b
timeFrame: up to 36 months
measure: Time to maximum plasma concentration (Tmax) for DS-1001b
timeFrame: up to 36 months
measure: Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b
timeFrame: Baseline, up to 36 months
measure: Tumor response to DS-1001b based on Response Assessment in Neuro-Oncology Criteria (RANO)
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT00245466: Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients
Official title: An Open-Label, Multi-Centre, Extension Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Androgen ablation therapy
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-10-28
Enrollment: 88
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the long-term safety and tolerability of repeated doses of degarelix to prostate cancer patients

Detailed description: Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked "YES").

The data include participants from both the main study (FE200486 CS02; NCT00819247) and the extension study FE200486 CS02A.

Eligibility criteria: Inclusion Criteria:

* Has completed study treatment in study FE200486 CS02.
* Has completed visit 16 in study FE200486 CS02.
* Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02

Primary outcomes:
measure: Liver Function Tests
timeFrame: 3 years
measure: Participants With Markedly Abnormal Change in Vital Signs and Body Weight
timeFrame: 3 years
Secondary outcomes:
measure: Serum Levels of Testosterone After 1, 2, and 3 Years
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT00953966: Metabolic Changes Induced by Genetically Modified Potatoes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glucose Metabolism
Endocrine Metabolism
Satiety
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Starches from genetically modified potatoes, which differed in terms of amylose, amylopectin and phosphate content, were tested in a human randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* healthy males

Exclusion Criteria:

* no acute oder severe chronic diseases

Primary outcomes:
measure: Glucose metabolism
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité, Dept. of Endocrinology, Diabetes and Nutrition
Study officials:
References:
Clinical trial NCT05843266: Early Childhood Attention Battery in Preterm Children
Official title: A Study on the Application of the Early Childhood Attention Battery in a Population of Preterms Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention-deficit
Prematurity
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 42
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Low risk preterm children

Brief summary: The aims of this project are:

1. To explore, using the ECAB, if and in which measure the attentional abilities of young preterm children are different from term peers, whom reference data are already published27.
2. To correlate the ECAB results with the "Conner's Teacher, Rating Scale- Revised e Conner's Parent Rating Scale", one of the available diagnostic interview that helps to identify signs of Attention Deficit Hyperactivity Disorder (ADHD) in young children, at the age of 6 years and over.
3. To study individual trajectories of attention pattern and development during age.


Eligibility criteria: Inclusion Criteria:

* gestational age (GA) \<34 weeks, intellectual functioning with Intelligence Quotient (IQ\>70 verified with Wechsler scales performed within 6 months from the ECAB, age at ECAB assessment between 3 years and 5 years 11 months.

Exclusion Criteria:

* presence of major brain lesions, major motor or behavioral disorders, WPPSI-III subtest receptive vocabulary with a scaled score \<8.

Primary outcomes:
measure: attentional abilities of young preterm children
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli
Study officials:
References:
Clinical trial NCT01723566: PANORAMA 2 Observational Study
Official title: Panorama 2 Medtronic CRDM Implantable Cardiac Device Long Term Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Rhythm Disorders
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2012-11-08
Enrollment: 4706
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that have a Medtronic implantable CRDM Device implanted (including Vitatron), which is commercially available at the start of the registry or becomes commercially available during the course of the registry, and used within its intended use, may be included.

These products are:

* Pacemaker systems: Implantable Pulse Generators (IPG) and cardiac leads
* Defibrillation systems: Implantable Cardioverter Defibrillators (ICD) and cardiac leads
* Resynchronization systems: Cardiac Resynchronization Therapy (CRT):

  * Cardiac Resynchronization Therapy - Pacemaker (CRT-P) and cardiac leads
  * Cardiac Resynchronization Therapy - Defibrillator (CRT-D) and cardiac leads
* Implantable Loop Recorders (ILR)

Brief summary: Understanding the clinical practice of treatment of cardiac rhythm disorders all over the world and understanding the clinical outcomes of the treatment with its cardiac rhythm products in real world patient population is essential for Medtronic to be able to effectively develop new products and adjust existing products. In addition Medtronic is committed to monitor the safety of its products throughout the entire life cycle to ensure maximum product reliability.

The Panorama 2 registry will enable Medtronic to increase data collection of clinical practice with Medtronic implantable Cardiac Rhythm and Disease Management (CRDM) devices in various regions across the world and on product reliability of its CRDM devices.


Eligibility criteria: Inclusion criteria:

* Patient is 18 years of age or older (lower age limit dependent on local law: to be specified in country-specific addendum to the clinical investigational plan, if applicable)
* Patient or Legally Authorized Representative provides signed and dated authorization and/or consent per institution and local requirements
* Patient will be treated with a commercially available implantable Medtronic CRDM device/ Vitatron device within maximally 30 days after enrollment or within 3 days prior to enrollment

Exclusion criterion:

• Patient has exclusion criteria per local law (to be specified in country-specific addendum to the clinical investigational plan, if applicable)

Primary outcomes:
measure: Describe region-specific clinical practice of CRDM device use
timeFrame: 2012-2019
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospital
Study officials:
References:
Clinical trial NCT05249166: Feeding for Accesible, Affordable and Healthy Childhood
Official title: Feeding for Accesible, Affordable and Healthy Childhood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Children
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Universidad Pública de Navarra
name: Gobierno de Navarra
First posted: 2022-02-21
Enrollment: 70
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of this study was to evaluate the effectiveness of implementing a healthy eating vs traditional recommendations on the Medkid index of children in primary school. To do so, different companies involved in ALINFA project developed with the assessment of UNAV, CNTA and UPNA, a healthy bi-weekly menu.


Eligibility criteria: Inclusion Criteria:

* Adequate cultural level and comprehension of the clinical study from the legal tutors.
* To agree in taking part of the study.

Exclusion Criteria:

* Children presenting clinically relevant gastrointestinal malfunctions or structural anomalies, such as ulcers, chronic inflammatory diseases, etc. Even if they do not follow any pharmacological treatment at the moment of inclusion.
* Children with uncontrolled endocrine disorders.
* Children with any type of tumor/cancer within the last 5 years, or in current treatment.
* Children with any alimentary allergy.
* Children presenting any type of cognitive or psychic disorder
* Parents or legal tutors in which their future collaboration may not be the required, seen from the researchers' point of view.

Primary outcomes:
measure: Dietary Pattern (questionnaire)
timeFrame: Baseline
measure: Dietary pattern (questionnaire)
timeFrame: 8 week
measure: Dietary pattern (questionnaire)
timeFrame: Baseline vs 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Center for Nutrition Research. University of Navarra
state: Navarra
Study officials:
affiliation: University of Navarra
name: Santiago Navas Carretero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03509766: Randomized Evaluation of Ten Allergy Skin Prick Test Devices
Official title: Randomized Evaluation of Ten Allergy Skin Prick Test Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Asthma
Food Allergy
Skin Testing
Keywords: allergic
rhinitis
allergy
asthma
food allergy
skin testing
skin prick test
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to compare ten current and readily available FDA approved allergy skin prick devices to determine the most sensitive and specific product and methods used for the diagnosis of allergic disease. The primary outcome will be to determine the analytical sensitivity and specificity of all ten skin prick devices by measuring wheal and flare response to histamine and control diluent in 1mm increments. Secondary outcomes include comparison of skin prick technique, optimum histamine concentration, patient comfort, reproducibility, and the comparability of high-resolution digital images.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18-65 with or without allergic disease

Exclusion Criteria:

* severe concurrent illness
* uncontrolled asthma
* extensive eczema
* urticaria
* dermatographism
* pregnancy
* those taking antihistamines within the previous 10 days
* topical steroids
* immunomodulatory drugs
* long term use of oral steroids

Primary outcomes:
measure: Wheal Response
timeFrame: 15 minutes
measure: Sensitivity
timeFrame: 15 minutes
Secondary outcomes:
measure: Skin Prick Techniques/Methodology Ratio
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: John Hopkins Asthma and Allergy Center
state: Maryland
Study officials:
References:
Clinical trial NCT01284166: Safety and Efficacy of Triple Combination Therapy With Dorzolamide Hydrochloride / Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety and efficacy of Triple Combination Therapy with dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution in patients with glaucoma or ocular hypertension who have elevated IOP on dorzolamide hydrochloride/timolol maleate combination therapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ocular hypertension or glaucoma in each eye
* Requires IOP-lowering treatment in both eyes

Exclusion Criteria:

* Use of dorzolamide or carbonic anhydrase within 4 weeks
* Any other active ocular disease other than ocular hypertension or glaucoma (eg, uveitis, ocular infections or severe dry eye)
* Required chronic use of ocular medications other than study medication during the study (intermittent use of certain products eg, artificial tears are permitted)
* Use of oral, injectable or topical ophthalmic steroids within 21 days
* Any eye laser surgery within 3 months
* Any intraocular surgery (eg cataract surgery) within 6 months

Primary outcomes:
measure: Change from Baseline in Intraocular Pressure (IOP)
timeFrame: Baseline, Week 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: