louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02881710: Variation IGFBP7 Markers and TIMP2 Induced by Injection of Contrast Iodized Drug at the Intensive Care Patient
Official title: Variation IGFBP7 Markers and TIMP2 Induced by Injection of Contrast Iodized Drug at the Intensive Care Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Medical and surgical intensive care adult patients undergoing CT with PCI intravenous injection.

Brief summary: Multicenter, prospective, uncontrolled study to evaluate variations in urinary concentrations of TIMP-2 and PCI IGFBP7 induced injection during a CT scan in intensive care patient.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or more,
* Hospitalized in intensive care,
* Holders of a urinary catheter
* Patient receiving a first CT with intravenous injection of PCI during their ICU stay.
* Patient agreeing to participate in the research protocol

Exclusion Criteria:

* Anuria
* Need to retain urine, whatever the reason (eg measurement of 24-hour proteinuria).
* Urine unanalyzable whatever reason (eg urinary washing with double current probe, injection is saline to measure bladder pressure.).
* Patient subjected to renal replacement
* Patient already included in the study for a previous injection of PCI in intensive care.

Primary outcomes:
measure: significant increase in urinary concentrations of TIMP-2 and IGFBP7 defined as an increase of NephroCheck® test of more than 0.2 [ng / mL] 2/1000) after PCI injection
timeFrame: follow up: 5 days after injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03291210: O2 Tension During TAVI
Official title: Effect of O2 Tension on Myocardial Injury During TAVI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Troponin
Keywords: hyperoxemia
myocardial injury
transcatheter aortic valve replacement
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hyperoxemia can produce various complications including oxidative stress and myocardial injury. We hypothesized that the normoxic group would have lower myocardial injury compared to hyperoxic group after transcatheter aortic valve replacement.

Detailed description: Hyperoxemia can produce various complications, such as excessive oxidative stress, hyperoxia-induced vasoconstriction, increased perfusion heterogeneity, and resultant myocardial injury. Previous studies have been observed higher mortality in patient group maintained with supranormal oxygenation after resuscitation from cardiac arrest. However, the effect of hyperoxia vs. normoxia on myocardial injury during transcatheter aortic valve replacement (TAVR) has not been well investigated. We hypothesized that the normoxic group would have lower myocardial injury compared to hyperoxic group after TAVR.

Eligibility criteria: Inclusion Criteria:

* Scheduled for transcatheter aortic valve replacement due to aortic stenosis

Exclusion Criteria:

* Transapical approach
* Pre-procedural PaO2 \< 65 mmHg or oxygen support therapy
* Pre-procedural severe kidney injury (end-stage renal disease)
* Pre-procedural chronic pulmonary disease, symptomatic asthma
* Pre-procedural Tb-destroyed lung
* Lung cancer
* History of acute coronary syndrome within 6 months
* Pre-procedural elevated Troponin I or CKMB
* History of stroke or transient ischemic attack within 6 months
* Refuse to participate
* Pregnant

Primary outcomes:
measure: Troponin I
timeFrame: 72 hours after the end of procedure
Secondary outcomes:
measure: CK MB
timeFrame: 72 hours after the end of procedure
measure: Changes in cerebral oximetry
timeFrame: through procedure completion, an average of 3 hours
measure: Delirum
timeFrame: through admission completion, an average of 5 days
measure: AKI or RRT
timeFrame: through admission completion, an average of 5 days
measure: stroke, myocardial infarction or mortality
timeFrame: through admission completion, an average of 5 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yunseok Jeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02316210: Optimization of Onpulse Technology for Patients With Post Surgical or Vascular Oedema
Official title: Optimization of Onpulse Technology for Patients With Post Surgical or Vascular Oedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Oedema
Neuropathy
Lead sponsor: Firstkind Ltd
Sponsor class: INDUSTRY
First posted: 2014-12-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to facilitate further optimization of a neuromuscular electrical stimulation device for use in patients whom are suffering from oedema and neuropathy


Eligibility criteria: Inclusion Criteria:

1. Aged 18 years and over
2. Be a non-responder to the geko MK1\&2 device
3. Able to understand the Subject Information Sheet and willing to sign the written Informed Consent Form.
4. Able and willing to follow the protocol requirements.

Exclusion Criteria:

1. Has a pacemaker
2. Pregnancy.
3. Is contraindicated for the MK1\&2 device and/or the Digitimer DS7A
4. Recently diagnosed or suspected DVT

Primary outcomes:
measure: Observable foot twitch in response to stimulation with Digitimer DS7A
timeFrame: up to 2 hours
Secondary outcomes:
measure: adverse events
timeFrame: up to 2 hours
measure: oedema
timeFrame: up to 2 hours
measure: patient rated tolerability questionnaire
timeFrame: up to 2 hours
Other outcomes:
Locations:
city: Poole
country: United Kingdom
facility: BMI Harbour hospital
state: Dorset
Study officials:
References:
Clinical trial NCT05277610: Iron Status and Lung Function in Pediatric Asthma
Official title: Iron Status and Its Relation to Lung Function in Pediatric Asthmatics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Function Tests
Keywords: asthma, pediatric, iron deficiency anemia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asthmatic children with and without iron deficiency anemia

Brief summary: Iron has a variable role regarding asthma and respiratory function. In addition, iron deficiency may affect spirometry results in asthmatic children. So, we aimed to assess the effect of ion status on lung function in childhood asthma

Detailed description: This cross-sectional study included fifty asthmatic children in the age group of 6-16 years. Asthmatic patients were classified according to their complete blood count and iron profile into 2 groups: group 1; asthmatic children without iron deficiency anemia (IDA), group 2; asthmatic children with IDA. All patients underwent full history taking, clinical examination, laboratory investigations, asthma control test, and pulmonary function tests.

Pulmonary function testing was performed using standardized spirometry. Lung function was measured by forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC, and maximal mid-expiratory flow (MMEF 25-75%) of FVC. both patients' groups are compared.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of bronchial asthma: The diagnosis of bronchial asthma in the studied children was based on clinical examination The diagnosis of iron deficiency anemia was supported by criteria provided and updated by the World Health Organization

Exclusion Criteria:

* chronic lung diseases other than asthma Severe systemic illnesses such as liver, renal diseases, and nutritional disorders

Primary outcomes:
measure: improved asthma control
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Heba Omara
state: Lecturer/Instructor
Study officials:
References:
Clinical trial NCT04329910: Obesity Alters Lung Mechanics in Robotic Surgery
Official title: Dynamic Surgical Conditions and Body Habitus Independently Impair Pulmonary Mechanics During Robotic Assisted Laparoscopic Surgery: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Surgery
Anesthesia
Lead sponsor: University of Vermont Medical Center
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing robotic assisted laparoscopic abdominal surgery at the University of Vermont Medical Center

Brief summary: Intraoperative lung protective ventilation strategies using standardized tidal volumes based on predicted body weight have proven beneficial, but attempts to standardize positive end expiratory pressure (PEEP) settings have not robustly accounted for body habitus or dynamic surgical conditions. Laparoscopic abdominal surgery in Trendelenburg (head-down) is an increasingly common surgical modality that presents a unique physiological challenge to the pulmonary system. In order to delineate the impact of body habitus, pneumoperitoneum, and surgical positioning on intraoperative pulmonary mechanics we conducted an observational study of patients undergoing robotic assisted laparoscopic abdominal surgery in Trendelenburg position. Using esophageal manometry, we partitioned the mechanical properties of the respiratory system into its lung and chest wall components and evaluated the effects of pneumoperitoneum, surgical position, and body mass index (BMI) on transpulmonary pressures, airway and transpulmonary driving pressures, and lung elastance. We hypothesized that increasing BMI would be associated with evidence of increasing atelectasis, increased driving pressures, and elevated lung elastance and that these changes would be exacerbated by pneumoperitoneum and Trendelenburg positioning.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were presentation for robotic assisted laparoscopic abdominal surgery in the supine position, age ≥ 18 years, and ability to provide informed consent

Exclusion Criteria:

* Exclusion criteria included intrinsic lung disease, ≥ 20 pack year smoking history, reactive airways disease, home oxygen requirement, inability to provide informed consent, emergent surgery, or esophageal pathology (i.e., strictures, varices, history of esophageal dilatation or surgery).

Primary outcomes:
measure: Transpulmonary pressure
timeFrame: during the surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vemont Medical Center
state: Vermont
Study officials:
References:
Clinical trial NCT04548310: Muscle Fatigue in Patients With Multiple Sclerosis
Official title: Effect of Muscle Fatigue on Strength, Joint Position Sensation, and Walking in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
gait
sensation
fatigue
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ambulatory sample

Brief summary: It is stated that 85% of patients with Multiple Sclerosis (MS) complain of gait disorders and 35-90% of them have fatigue. Many factors play a role in the fatigue mechanism in MS patients. Fatigue can increase the symptoms that already exist in MS patients. It is thought that fatigue caused a decrease in muscle strength, making walking worse. There are not enough studies investigating whether fatigue affects gait parameters in MS patients.

The aim of this study is to examine the effects of muscle fatigue on muscle strength, joint position sensation, and gait in MS patients.

Detailed description: Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The muscle strength, joint position sensation, gait, and fatigue will be evaluated once.

The investigators will use descriptive statistics and t-tests to compare demographic characteristics between groups and for the categorical variables chi-square. Effect of the group (MS patients or healthy controls), condition (Single task and dual-task conditions), and group × condition interaction will be compared using two-way repeated-measures ANOVA.

Eligibility criteria: Inclusion Criteria:

* Participants who 18-65 years of age
* MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month

Exclusion Criteria:

* Participants who have orthopedic, vision, hearing, or perception problems

Primary outcomes:
measure: Knee proprioception
timeFrame: 10 minutes
measure: Knee strength
timeFrame: 20 minutes
measure: Gait
timeFrame: 5 minutes
measure: Perceived Exertion
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Cagla Ozkul, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suzuki, F. S., Mazuchi, F. A. S., Miranda, M. L. J., Maifrino, L. B. M., Mochizuki, L., & Ervilha, U. F. (2013). What is the most effective protocol to induce fatigue in knee joint muscles? a systematic review. J. Morphol, 30(3), 143-147.
Clinical trial NCT03546010: Oculometry as an Attentional Mechanism Evaluation Tool and Attention Deficit Hyperactivity Inhibition
Official title: Oculometry as an Attentional Mechanism Evaluation Tool and Attention Deficit Hyperactivity Inhibition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit-Hyperactivity
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to analyse thanks to eye tracking experiments ocular movement classical parameters in children with attention deficit hyperactivity (ADH) and to compare them to results obtained in healthy children and to results obtained with neuropsychological tests commonly used in standard health care.

We should then be able to compare eye tracking with neuropsychological parameters.

The final objective is to give to health professional a tool for ADH investigation with which they should be able to do a simple and effective follow up of children with ADH.


Eligibility criteria: Inclusion Criteria:

* Children between 8 and 12 years old
* Boys and girls
* DSM-IV-TR diagnostic criteria for ADH
* Children with methylprednisone treatment
* Social security affiliation
* signed informed consent

Exclusion Criteria:

* specialised scholarship
* refusal from children or parents
* too law results in WISC test (pre-inclusion test)

Primary outcomes:
measure: Correlation between oculometric and neuropsychological tests in ADH evaluation
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble Alps Hospital
Study officials:
affiliation: Grenoble Alps University Hospital
name: Annie Laurent, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Malsert J, Guyader N, Chauvin A, Polosan M, Szekely D, Bougerol T, Marendaz C. Saccadic performance and cortical excitability as trait-markers and state-markers in rapid cycling bipolar disorder: a two-case follow-up study. Front Psychiatry. 2013 Jan 4;3:112. doi: 10.3389/fpsyt.2012.00112. eCollection 2012.
Clinical trial NCT06615310: Ultrasonographic Parameters in Stroke Patients With Dysphagia
Official title: The Relationship of Ultrasonographic Parameters Used in the Evaluation of Dysphagia in Stroke Patients With Swallowing Severity
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke
Dysphagia
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-09-26
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with stroke at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital and enrolled in a rehabilitation program will be divided into 2 groups according to the presence of dysphagia (3 points and above according to the EAT-10 scale).

Brief summary: ultrasonographic parameters in stroke patients with dysphagia


Eligibility criteria: Inclusion Criteria: Diagnosis of stroke,

* Agreeing to participate in the study,
* Cognitive competence to understand the test instructions
* Communication skills to respond to the test instructions.

Exclusion Criteria:

* Presence of a neurological disease other than stroke that will cause difficulty in swallowing, -Being illiterate,
* refusing to participate in the study,
* jaw joint problem,
* surgical intervention in the neck area that will affect ultrasound measurements,
* infected open wound

Primary outcomes:
measure: muscle volume of thyrohyoid
timeFrame: baseline
Secondary outcomes:
measure: muscle volume of sternohyoid
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00337610: Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
Official title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-06-16
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.


Eligibility criteria: Inclusion Criteria:

* Patient has type 2 diabetes mellitus
* Males
* Females who are highly unlikely to become pregnant
* Patients poorly controlled while taking one or two oral antidiabetic medications

Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
* Patient required insulin therapy within the prior 8 weeks
* Patient is on or has been taking Thiazolidinediones (TZDs) such as Actos® (pioglitazone) or Avandia® (rosiglitazone) or is on or has been taking Byetta® (exenatide) within the prior 12 weeks of the screening visit

Primary outcomes:
measure: Change From Baseline in A1C at Week 18
timeFrame: Baseline and Week 18
Secondary outcomes:
measure: Change From Baseline in FPG at Week 18
timeFrame: Baseline and Week 18
measure: Change From Baseline in 2 Hr-PMG at Week 18
timeFrame: Baseline and Week 18
measure: Change From Baseline in A1C at Week 30
timeFrame: Baseline and Week 30
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Raz I, Chen Y, Wu M, Hussain S, Kaufman KD, Amatruda JM, Langdon RB, Stein PP, Alba M. Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes. Curr Med Res Opin. 2008 Feb;24(2):537-50. doi: 10.1185/030079908x260925.
Clinical trial NCT03906110: Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES)
Official title: Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) : A Multilevel Intervention to Increase Colorectal Cancer Screening Adherence In Community Clinics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer Screening
FIT test
Fecal Immunochemical Test
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Florida Department of Health
First posted: 2019-04-08
Enrollment: 327
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Established patients of community health clinics aged 50-75 with average risk of colorectal cancer.

Brief summary: The purpose of this study is to test if including personalization in education materials about colorectal cancer screening is more effective at helping encourage people to complete colorectal cancer screening.


Eligibility criteria: Inclusion Criteria:

* Able to understand, read and speak English or Spanish
* Are not up-to-date with colorectal cancer screening
* No symptoms of colorectal cancer
* Not at increased risk for colorectal cancer due to family history or personal high-risk GI syndromes

Exclusion Criteria:

* Symptoms of colorectal cancer
* Family history of colorectal cancer

Primary outcomes:
measure: Fecal Immunochemical Test (FIT) use -Time Point 1
timeFrame: Time Point 1 (at 3 months)
measure: Fecal Immunochemical Test (FIT) Use- Time Point 2
timeFrame: Time Point 2 (up to 18 months)
measure: Fecal Immunochemical Test (FIT) Use- Time Point 3
timeFrame: Time Point 3 (End of study, up to 30 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Clement K Gwede, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christy SM, Sutton SK, Abdulla R, Boxtha C, Gonzalez P, Cousin L, Ewing A, Montoya S, Lopez D, Beehler T, Sanchez J, Carvajal R, Meade CD, Gwede CK. A multilevel, low literacy dual language intervention to promote colorectal cancer screening in community clinics in Florida: A randomized controlled trial. Prev Med. 2022 May;158:107021. doi: 10.1016/j.ypmed.2022.107021. Epub 2022 Mar 17.