louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00919698: Delirium in Mechanically Ventilated Patients
Official title: An Assessment of Delirium in Mechanically Ventilated Patients Undergoing Daily Awakening From Sedation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Hypnotics and Sedatives
Respiration, Artificial
Ventilators, Mechanical
Critical care
Intensive care
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-06-12
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients (\> 18 years old) admitted to the intensive care unit who require mechanical ventilation through an endotracheal tube with infusion of sedative or analgesic medication.

Brief summary: The overall purpose of this trial is to assess the relationship between a daily awakening from sedation and the prevalence of delirium, and in doing so better characterize delirium in the ICU.

Detailed description: This is a single center, observational, cross-over design study assessing the impact of daily awakening from sedation on delirium in the ICU. Enrolled patients will receive a daily baseline delirium assessment using the CAM-ICU tool before the awakening from sedation and an assessment during the awakening from sedation. Each patient will thus serve as their own controls for these interventions.

Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* intubated and mechanically ventilated
* receiving sedative and/or analgesic medication
* candidate for daily awakening from sedative and/or analgesic medication

Exclusion Criteria:

* primary neurologic disease (stroke, seizure, elevated ICP)
* post cardiac arrest
* do not speak English (assessment only English language validated)

Primary outcomes:
measure: Delirium
timeFrame: Daily
Secondary outcomes:
measure: ICU admitting diagnosis
timeFrame: At enrollment
measure: Medications
timeFrame: Daily
measure: Ventilator free days (or first 28)
timeFrame: At 28 days post-intubation
measure: ICU complications
timeFrame: Daily
measure: Days to discharge
timeFrame: At discharge
measure: Survival
timeFrame: At discharge
Other outcomes:
measure: survival
timeFrame: 1 year
measure: institution free days
timeFrame: 1 year
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: John P Kress, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel SB, Poston JT, Pohlman A, Hall JB, Kress JP. Rapidly reversible, sedation-related delirium versus persistent delirium in the intensive care unit. Am J Respir Crit Care Med. 2014 Mar 15;189(6):658-65. doi: 10.1164/rccm.201310-1815OC.
Clinical trial NCT00168298: A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Edema
Retinal Vein Occlusion
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 668
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.


Eligibility criteria: Key Inclusion Criteria:

* 18 years of age or older with macular edema resulting from retinal vein occlusion
* Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
* Visual acuity in other eye no worse than 20/200

Key Exclusion Criteria:

* Known anticipated need for ocular surgery within next 12 months
* History of glaucoma or current high eye pressure requiring more than 1 medication
* Diabetic retinopathy
* Uncontrolled systemic disease
* Known steroid-responder
* Use of systemic steroids
* Use of warfarin/heparin

Primary outcomes:
measure: Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Day 180
Secondary outcomes:
measure: Change From Baseline in Retinal Thickness in the Study Eye
timeFrame: Baseline, Day 90, Day 180
measure: Percentage of Patients With a Change From Baseline in BCVA by Category
timeFrame: Baseline, Day 90
measure: Percentage of Patients With a Change From Baseline in BCVA by Category
timeFrame: Baseline, Day 180
Other outcomes:
Locations:
city: Houston
country: United States
state: Texas
city: Sao Paulo
country: Brazil
city: Mississauga
country: Canada
state: Ontario
city: Bogota
country: Colombia
city: Kowloon
country: Hong Kong
city: Tamil Nadu
country: India
city: Udine
country: Italy
city: Seoul
country: Korea, Republic of
city: Auckland
country: New Zealand
city: Poznan
country: Poland
city: Singapore
country: Singapore
city: Alicante
country: Spain
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, Loewenstein A, Yoon YH, Jacques ML, Jiao J, Li XY, Whitcup SM; OZURDEX GENEVA Study Group. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010 Jun;117(6):1134-1146.e3. doi: 10.1016/j.ophtha.2010.03.032. Epub 2010 Apr 24.
Clinical trial NCT01219205: Major and Macular Branched Retinal Venous Occlusion
Official title: Intravitreal Bevacizumab for Macular Edema Secondary to Major and Macular Branch Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Edema
Keywords: macular edema secondary to retinal benous occlusion
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although it is important in the clinical management to classify BRVO into subtypes based on the location of the occlusion (major or macular), few studies have provided such information\[8,9\]. The aim of this study was to evaluate the outcome of patients with macular edema due to Branch retinal vein occlusion who were treated with intravitreal bevacizumab injection and to determine the concentrations of cytokines in the aqueous humor according to the site of the occlusion.

Detailed description: Branch retinal vein occlusion is the second most frequent major retinal vascular disease after diabetic retinopathy. One of the main reasons for visual loss in BRVO is the development of macular edema. Treatment options for BRVO include grid laser treatment, intravitreal injection of steroids, surgical procedures, and off-label treatment with intravitreal anti-vascular endothelial growth factor (VEGF) agents. During recent years, intravitreal anti-VEGF treatment with bevacizumab has been shown to efficiently reduce macular edema and improve visual acuity in numerous case series and prospective or retrospective studies.

Eligibility criteria: Inclusion Criteria:

* macular edema involving the center of the fovea with a minimum central macular thickness at baseline of ≥250 μm

Exclusion Criteria:

* previous vitreoretinal surgery, intravitreal injections or laser treatment

Primary outcomes:
measure: efficacy of intravitreal bevacizumab
timeFrame: baseline and 12 months after initial injection
Secondary outcomes:
measure: cytokine levels in aqueous humor
timeFrame: before intravitreal injection
Other outcomes:
Locations:
city: Chuncheon-si
country: Korea, Republic of
facility: Ji Won Lim
state: Kangwon-do
Study officials:
affiliation: Hallym Medical center
name: Ji Won Lim, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT03641105: Investigation of the Contents and Prognostic Values of Glucose Metabolism Molecules in Patients With Lung Adenocarcinoma
Official title: Investigation of the Contents and Prognostic Values of Glucose Metabolism Molecules in Patients With Lung Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Glycolysis
Diagnosis
Survival
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 100
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: patients with primary lung adenocarcinoma

Brief summary: Detect the contents of glucose metabolism molecules in the tumor and adjacent normal samples of about 100 patients with lung adenocarcinoma using mass spectroscopy. Analyze the correlation between the contents and the clinicopathological characteristics and survival.


Eligibility criteria: Inclusion Criteria:

* Primary lung adenocarcinoma

Exclusion Criteria:

* Other tumor histories, received radiotherapy or chemotherapy before surgery, tumor or adjacent normal tissues can't be obtained, patient rejected.

Primary outcomes:
measure: disease-free survival
timeFrame: 1 month
Secondary outcomes:
measure: overall survival
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02893605: Study of Gene Polymorphisms Involved in the Metabolism and Action of Vitamin D in Amyotrophic Lateral Sclerosis
Official title: Study of Gene Polymorphisms Involved in the Metabolism and Action of Vitamin D in Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A national biological (France) collection has been in existence since 1996 and serves as a source for patient and control samples. Patients have a sporadic form of Amyotrophic Lateral Sclerosis and controls are their spouses/partners.

Brief summary: This is a case-control study performed on a biological collection. The polymorphisms present on a pre-defined list of genes will be studied for 400 Amyotrophic Lateral Sclerosis (sporadic type) DNA samples and 400 control DNA samples.


Eligibility criteria: Inclusion Criteria:

* The primary inclusion criterium is the same for that of the parent biological collection, i.e. the patients fulfill requirements for probable or definite Amyotrophic Lateral Sclerosis as defined by revised international criteria (Brooks et al 2000).
* Additionally, included patients were followed-up by doctors at the University Hospital of Montpellier, thus enabling verification of Amyotrophic Lateral Sclerosis criteria over time.

Exclusion Criteria:

* The patient has a familial form of Amyotrophic Lateral Sclerosis (autosomic dominant or recessive types) with or without a mutation of one of the 3 genes known to be responsible for familial forms (SOD1, TARDBP, FUS). See Bender (1998).

Primary outcomes:
measure: The polymorphisms occurring on a pre-defined set of genes
timeFrame: Day 0 (transversal study)
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier Cedex 5
country: France
facility: CHU de Montpellier - Hôpital Gui de Chauliac
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Kevin Mouzat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9. doi: 10.1080/146608200300079536. No abstract available.
citation: Bender PL. Genetic family history assessment. AACN Clin Issues. 1998 Nov;9(4):483-90; quiz 615-7. doi: 10.1097/00044067-199811000-00003.
Clinical trial NCT06190405: Universal Hemoglobin A1c Versus Risk-based Screening for Early Gestational Diabetes Mellitus (EARLY GDM): A Randomized Controlled Trial
Official title: Universal Hemoglobin A1c Versus Risk-based Screening for Early Gestational Diabetes Mellitus (EARLY GDM): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Large for Gestational Age
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 770
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The goal of this randomized controlled trial is to compare the rate of large-for-gestational-age neonates between universal screening with glycated hemoglobin (A1C) and early risk-based screening with a glucose tolerance test (GTT) among pregnancies that present to prenatal care at \<16 weeks 6 days.


Eligibility criteria: Inclusion Criteria:

* Presenting to prenatal care ≤16 6/7 weeks of gestation
* Intend to deliver at TJUH

Exclusion Criteria:

* Multifetal gestation
* Pre-pregnancy diagnosis of diabetes mellitus
* History of malabsorptive gastric bypass surgery
* Hemoglobinopathy

Primary outcomes:
measure: Large-for-gestational age
timeFrame: At time of delivery
Secondary outcomes:
measure: Preterm birth
timeFrame: At time of delivery
measure: Stillbirth
timeFrame: At time of delivery
measure: Shoulder dystocia
timeFrame: At time of delivery
measure: Birth injury
timeFrame: At time of delivery
measure: Neonatal hypoglycemia
timeFrame: From 0 to 24 hours after birth
measure: Neonatal death
timeFrame: 28 days after birth
measure: Rate of early GDM diagnosis
timeFrame: At time of delivery
measure: Rate of GDM diagnosis after 24 weeks
timeFrame: At time of delivery
measure: Rate of pregestational diabetes
timeFrame: At time of delivery
measure: Rate of patients requiring medication
timeFrame: At time of delivery
measure: Rate of hypertensive disorders of pregnancy
timeFrame: At time of delivery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01418898: Nutrient Fortified Oat Drink
Official title: The Effect of a Nutrient Fortified Oat Drink on Iron, Zinc, Vitamin A, and Vitamin C Status Among Filipino Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Iron Deficiency Anemia
Keywords: Iron deficiency anemia
iron
zinc
vitamin A
vitamin C
oats
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
Collaborators: name: PepsiCo - Philippines
First posted: 2011-08-17
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will follow a randomized, double-blind, placebo-controlled, parallel-group design to test if an oat beverage fortified with iron, zinc vitamin A and vitamin C will improve nutrient status and iron deficiency in young children compared to an unfortified control beverage.


Eligibility criteria: Inclusion Criteria:

* 5-7 years old
* Children with parental consent
* Not suffering from diarrhea, respiratory infections and fever at time of interview and for the past two weeks
* No history of blood disorder or malaria
* Had not participated in any feeding program for the past 4 months
* Children with Hb \> 70 g/L to \<120 g/L (WHO/UNICEF/UNU, 1998)
* CRP \<10 mg/L

Exclusion Criteria:

* All children aged \< 5 years old and \> 7 years old
* Without parental consent
* Undergoing treatment for any chronic ailment, diagnosed as suffering from any sort of illness e.g. fever, diarrhea, stomach ache, cough and colds at the time of examination or during the past two weeks.
* Reported current or history of blood abnormalities/hemoglobinopathies
* Children with all normal Hb levels or very low Hb \< 70 g/L
* CRP \>10mg/L

Primary outcomes:
measure: Iron status: Change in hemoglobin and serum ferritin
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: zinc, vitamin A and vitamin C status
timeFrame: Baseline and 4 months
measure: Weight, height, CRP and frequency of illness
timeFrame: Baseline and 4 months
measure: Dietary intake
timeFrame: Baseline and 4 months
Other outcomes:
Locations:
city: Taguig City
country: Philippines
facility: FNRI
Study officials:
affiliation: FNRI
name: Imelda Angeles-Agdeppa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00918398: AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations
Official title: An Open, Single-dose, Phase I, 4-period Partly Crossover Study in Healthy Men or Women to Assess Relative Bioavailability of Oral Administration of AZD1981 Via Tablets Compared With Suspension and Basic Systemic Pharmacokinetic Parameters After Intravenous Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Postmenopausal
Surgically Sterile Women
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective is to investigate the pharmacokinetics of AZD1981 given in different formulations and to measure renal clearance


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Men or post-menopausal or surgically sterile women, aged 18 to 55 years
* Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to Visit 1 (pre-entry)

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
* Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study

Primary outcomes:
measure: PK samples for AZD1981 from both blood and urine
timeFrame: Intense PK-sampling during the 24 hours following dose and additional samples up to 60 hours after dose.
Secondary outcomes:
measure: Safety variables (adverse events and laboratory safety lab)
timeFrame: Adverese events registered during study and vital signs and ECG at visit 1,2 ,6
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Lund, Sweden
name: Eva Pettersson
role: STUDY_DIRECTOR
affiliation: Quintiles AB, Uppsala, Sweden
name: Elisabeth Eden
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06123598: Effects of Mental Practice and Therapeutic Exercise in Mild Smokers
Official title: Effects of Mental Practice and Therapeutic Exercise in Mild Smokers: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smokers
Keywords: smokers
therapeutic exercise
mental practice
respiratory function
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn about the effects who would add mental practice based on action observation to a therapeutic exercise program in young mild smokers.

The main question it aims to answer is whether the observation of actions prior to the implementation of a therapeutic exercise program improves the response to it on respiratory, strength and muscle function variables.

Participants will be assigned to one of 2 study groups:

G1) Therapeutic exercise plus action observation training (n=20) G2) Therapeutic exercise plus sham action observation training (n=20)


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* Had a pack per year index of \<5 (mild smoking index).

Exclusion Criteria:

Those who presented:

* a respiratory pathology,
* cardiac, systematic, or metabolic disease,
* history of recent surgery,
* vertebral fracture,
* or osteoarticular disorders of the spine area.

Primary outcomes:
measure: Respiratory strength
timeFrame: Before the start of the program, in the middle of the program (1 week) and at the end of the program (2 weeks)
Secondary outcomes:
measure: Spirometric parameters
timeFrame: Before the start of the program, in the middle of the program (1 week) and at the end of the program (2 weeks)
measure: Physical function
timeFrame: Before the start of the program, in the middle of the program (1 week) and at the end of the program (2 weeks)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universitat de Valencia
Study officials:
References: