louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04216407: The Effects Of Remote Organ Ischemic Preconditioning On Systemic Inflammatory And Glycocalyx Integrity Parameters
Official title: The Effects Of Remote Organ Ischemic Preconditioning On Systemic Inflammatory And Glycocalyx Integrity Parameters In Living-Donor Liver Transplantation Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Remote Organ Ischemic Preconditioning
Keywords: Remote organ ischemic preconditioning
Ischemia reperfusion injury
Glycocalyx integrity parameters
Systemic inflammation parameters
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ischemia-reperfusion (IR) injury during liver transplantation is one of the major causes of mortality and morbidity associated with transplantation. Remote organ ischemic preconditioning (RIPC) is one of the most investigated practices to reduce IR injury. In this study, for the first time in the clinic, the effect of RIPC will be evaluated via both systemic inflammation parameters and also parameters showing glycocalyx integrity, on living-donor liver recipients.


Eligibility criteria: Inclusion Criteria:

* Patients followed up by Acıbadem Hospital Organ Transplantation Center
* Patients accepted to participate in the study
* Older than 18 years of age
* ASA class III
* MELD score \>12
* Scheduled for elective liver transplantation surgery from a living donor

Exclusion Criteria:

* Patients undergoing re-transplantation
* Under the age of 18 years
* Patients undergoing emergency surgery
* Patients with hepatorenal or hepatopulmonary syndrome
* Patients receiving mechanical ventilation support in the ICU
* Patients refusing to participate

Primary outcomes:
measure: Tumor necrosis factor-alpha (TNF-alpha)
timeFrame: Postoperative early period (6 hours after intensive care unite admission)
measure: Intercellular adhesion molecule-1 (ICAM-1)
timeFrame: Postoperative early period (6 hours after intensive care unite admission)
measure: Hypoxia-induced factor-1 (HIF-1)
timeFrame: Postoperative early period (6 hours after intensive care unite admission)
measure: Interleukin-8 (IL-8)
timeFrame: Postoperative early period (6 hours after intensive care unite admission)
measure: Syndecan-1 (SDC-1)
timeFrame: Postoperative early period (6 hours after intensive care unite admission)
measure: soluble Vascular cell adhesion molecule-1 (sVCAM-1).
timeFrame: Postoperative early period (6 hours after intensive care unite admission)
Secondary outcomes:
measure: Mortality
timeFrame: 7 days after surgery
measure: Liver function tests
timeFrame: 7 days after surgery
measure: Length of stay in hospital and intensive care unit
timeFrame: 7 days after surgery
measure: Morbidity
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem Mehmet Ali Aydinlar University Atakent Hospital
state: Atakent
Study officials:
References:
Clinical trial NCT01807507: Clinical Verification Evaluation of VeinViewer® Device
Official title: Clinical Verification Evaluation of VeinViewer® Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vein Width
Keywords: Veins
Vascular Access
Lead sponsor: Christie Medical Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: Measure accuracy of vein width using VeinViewer®, compared against ultrasound imaging as a gold standard


Eligibility criteria: Inclusion Criteria:

* Must be 18 years of age or older
* Must be able to read and understand English to understand the consent letter

Exclusion Criteria:

* Less than 18 years of age
* Unable to read and understand English to understand the consent letter

Primary outcomes:
measure: Device validation versus ultrasound
timeFrame: Immediately after assessment-Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Kitchener
country: Canada
facility: Christie Medical Holdings, Inc.
state: Ontario
Study officials:
affiliation: Christie Medical Holdings, Inc.
name: Ben Wagner, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06345807: Innovative Care Pathway in Physical Activity and Behavior Change in Coronary Patients Post-cardiac Rehabilitation
Official title: Innovative Care Pathway in Physical Activity and Behavior Change in Coronary Patients Post Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Individualised Physical Activity Program
Coronary Patient
Keywords: cardiac rehabilitation
ischemic heart disease
physical activity
wearables
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: interventional study, randomized in 3 parallel groups, single center,
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this 18-month research is to show the effectiveness of an individualized physical activity( PA) compared to standard PA management and voluntary PA, to achieve a change in the behavior of the coronary patient.


Eligibility criteria: Inclusion Criteria:

* Post-infarction coronary artery patient aged 18 years and older, with no gender difference.
* Patients engaged in a follow-up care and cardiovascular rehabilitation program at the Supervaltech center.
* Patient at low to moderate RARE risk of complication (RARE score 2 to 3)
* Patients equipped with smartphones, laptops or other equipment compatible with downloading an application with their personal ID
* Patient able to understand French for the purpose of conducting the study.
* Affiliated member or beneficiary of a social security scheme.
* Participant who has been informed and has given free, informed and written consent (no later than the day of inclusion and before any examination required by the research).

Exclusion Criteria:

* Patients with a formal contraindication to physical activity such as: unstabilized coronary syndrome, decompensated heart failure, severe ventricular arrhythmias, intracardiac thrombus at risk embolic, PAH, moderate pericardial effusion, history of thrombophlebitis with or without pulmonary embolism, severe and/or symptomatic left ventricular ejection obstruction.
* Patients with ongoing infectious disease
* Participant whose physical and/or psychological health is severely impaired, which in the opinion of the investigator may affect the study participant's compliance.
* Participant included in other research
* Participant in a period of exclusion from another research still in progress at the time of inclusion.
* Protected participant: an adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
* Pregnant, breastfeeding or parturient women.
* Participant hospitalized without consent.

Primary outcomes:
measure: 6 minutes walk test
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinique SSR SuperValtech
name: Deva BAS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00575107: A System for Lengthening Contraction Training of Muscle
Official title: A System for Lengthening Contraction Training of Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: BioLogic Engineering, Inc.
First posted: 2007-12-18
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluation of a new exercise machine designed to improve strength and speed of movement in the leg muscles. Investigators are trying to learn whether a new training method results in greater strength improvements as compared to a traditional method.


Eligibility criteria: Inclusion Criteria:

* healthy
* able to exercise 3 times per week for 16 weeks at Mobility Research Center

Exclusion Criteria:

* under- or overweight
* chronic disease that limits ability to exercise
* hips and legs limited by arthritis or pain
* presently engaged in a strenuous exercise program
* planned absence greater than one week.

Primary outcomes:
measure: Leg strength
timeFrame: 16 weeks
Secondary outcomes:
measure: Ability to rise from a chair
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Mobility Research Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Neil Alexander, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05638607: Effect of Intensified Occupational Therapy on Basic Activities of Daily Living
Official title: Effect of Intensified Occupational Therapy on Basic Activities of Daily Living: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADL
Keywords: Stroke
Occupational therapy
Trial
Basic activities of daily living
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to investigate the effect of an intensified occupational therapy intervention on independence in basic activities of daily living (ADL) in subjects with stroke


Eligibility criteria: Inclusion Criteria:

* First-time stroke
* \<=4 on four of six Functional Independence Measure (FIM) basic ADL items

Exclusion Criteria:

* Not able to understand danish

Primary outcomes:
measure: Assessment of motor and process skills (AMPS)
timeFrame: Change in scores from baseline to scores following three weeks intervention
Secondary outcomes:
measure: Activities of Daily Living - Interview
timeFrame: Change in scores from baseline to scores following three weeks intervention
measure: Functional Independence Measure (FIM)
timeFrame: Change in scores from baseline to scores following three weeks intervention
measure: Goal Attainment Scaling
timeFrame: Following three weeks intervention
measure: Length of stay
timeFrame: Follow-up up to one year of admission for inpatient rehabilitation.
Other outcomes:
Locations:
city: Hammel
country: Denmark
facility: Hammel Neurorehabilitation Centre and University Research Clinic
state: Midtjylland
Study officials:
affiliation: Hammel Neurorehabilitation Centre and University Research Clinic
name: Jesper Fabricius, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03630107: In-Use Test of a Cosmetic Product in Subjects With Chronically Itchy Scalp
Official title: In-Use Test of a Shampoo (WO 5101) in Subjects With Pruritus of the Scalp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pruritus of the Scalp
Keywords: itchy scalp
chronic pruritus
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Sponsor class: INDUSTRY
Collaborators: name: SIT Skin Investigation and Technology Hamburg GmbH
First posted: 2018-08-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the tolerance of the Shampoo (WO 5101) on the scalp by a dermatologist and by the subjects themselves after four weeks of regular product use.

Additional objective of this clinical in-use study was to evaluate the cosmetic features and the acceptance of the product by means of a questionnaire at the end of the 4-week treatment period.


Eligibility criteria: Inclusion Criteria:

* age: ≥ 18 years
* with chronically itchy scalp
* normal to dry scalp or scalp prone to neurodermatitis

Exclusion Criteria:

* any deviation from the above-mentioned criteria
* users of sour hair conditioner
* subjects who wash their hair more than once a day
* other dermatological disorders (scars, moles) on the scalp
* known incompatibilities to cosmetics and ingredients of cosmetic test products (please see INCI)
* topical medication in the test area within 1 month prior to study start
* systemic medication with anti-inflammatory agents and antibiotics within two weeks prior to starting of the study
* systemic medication with retinoids, antihistamines and/or immunomodulators (e.g. cortisone, corticosterone, chemotherapeutic agents) within four weeks prior to starting of the study
* severe internistic disease that leads to pruritus

Primary outcomes:
measure: Dermatological Tolerance of the Test Product on the Scalp
timeFrame: baseline, four weeks
measure: Subjective Tolerance of the Test Product on the Scalp
timeFrame: baseline, four weeks
Secondary outcomes:
measure: Cosmetic Features of the Test Product
timeFrame: baseline, four weeks
measure: Reduction of Pruritus
timeFrame: baseline, four weeks
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: SIT Skin Investigation and Technology Hamburg GmbH
Study officials:
affiliation: Dermatologist
name: Kerstin Söhl, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05846607: A Deep Learning Approach to Identify Patients With Full Stomach on Ultrasonography
Official title: A Deep Learning Approach to Identify Patients With Full Stomach on Ultrasonography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastic Antrum
Keywords: Deep learning，gastric antrum
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Preoperative gastric ultrasonography is a newly developed tool used to evaluate gastric content and volume in assessing perioperative aspiration risk and guide anaesthetic management. And then build up effective clinical predictive models for identification of full stomach, which can predict the high aspiration risk.

Detailed description: Aspiration of gastric contents can be a serious anesthetic related complication. Preoperative fasting was a common practice to decrease perioperative aspiration risk. However，one of most important prescription of enhanced recovery after surgery protocols is the reduction of preoperative fasting time in opposition to the traditional recommendation of overnight fast. Gastric antral sonography prior to anesthesia may have a role in identifying patients at risk of aspiration. The aim of this study is to construct models using deep learning for identification of full stomach, which can predict the aspiration risk.

Eligibility criteria: Inclusion Criteria:

Patients undergoing surgery Age: 18\~85 yeas ASA 1\~3

Exclusion Criteria:

-Diabetes mellitus Upper gastrointestinal pathology such as hiatus hernia, oesophageal cancer Prior surgery to upper GI On medication that may affect gastric emptying time Pregnancy

Primary outcomes:
measure: Diagnostic accuracy of the model
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University affiliated Huashan Hospital
Study officials:
affiliation: Fudan University affiliated Huashan Hospital
name: Le tian Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00772707: A Multi-Center Investigation of Patient Acceptability of OPTI-FREE RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
Official title: A 30 Day, Multi-Centered, Open Label Study To Determine Comfort and Overall Contact Lens Wearing Experience Using OPTI-FREE RepleniSH® MPDS as Compared to COMPLETE®MPS Easy Rub™ or ReNu MultiPlus® in Daily Wear Soft Contact Lens Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: contact lens solution
OPTI-FREE RepleniSH
contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to demonstrate that current successful fulltime daily wear soft contact lens wearers using competitive multi-purpose solutions will note improved comfort when using OPTI-FREE RepleniSH®.


Eligibility criteria: Inclusion Criteria:

1. Participants must be between 18 and 65 years of age.
2. Must wear daily wear soft contact lenses a minimum of 8 hours per day,7 days a week.
3. Must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality.
4. Must be using either COMPLETE Multi-Purpose Solution (MPS) Easy Rub or ReNu MultiPlus brand solution for at least 30 continuous days prior to enrollment.
5. Must be free of any contact lens-related symptoms with regard to comfort and vision throughout their wearing hours prior to enrollment, with the exception of end-of-day dryness not limiting all day wear.
6. Must have best corrected distance visual acuity, with contact lenses, of 20/30 or better in each eye.
7. Must be willing to maintain pre-enrollment systemic medication regimens during the study.
8. Must be willing to not use any topical medications or rewetting drops during the 30 day clinical trial duration.
9. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Has used any topical medication or rewetting drops for 7 days prior to enrollment.
2. Achieves best visual correction by monovision.
3. Has modified their systemic medications within 30 days prior to enrollment.
4. Has switched brands of cosmetics during the 30 days prior to the study.
5. Has a history of allergy to any study product ingredients.
6. Is unwilling or unable to meet the study visit timeline.
7. Has any active corneal, eyelid or other anterior segment inflammation or infection, which, in the opinion of the Investigator, would adversely affect successful contact lens wear.
8. Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Comfort Ratings at Baseline
timeFrame: Baseline (Day 0)
measure: Comfort Ratings at 30 Days
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT03968107: Diagnostic Performance of Antenatal Ultrasound in the Localization of Intestinal Structures Involved in Malrotation With a Higher-risk of Volvulus
Official title: Diagnostic Performance of Antenatal Ultrasound in the Localization of Intestinal Structures Involved in Malrotation With a Higher-risk of Volvulus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Related
Keywords: malrotation
intestinal structures
mesenteric vessels
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with normal intestinal structure and requiring a fetal MRI for other reason

Brief summary: The aims of this study are:

* To assess the performance of third-trimester ultrasound scan in the localization of intestinal structures (small bowel, gut, mesenteric vessels..) involved in malrotations with a higher-risk of volvulus compared to a gold standard based on fetal MRI.
* To describe normal meconium progression (ultrasound and MRI), prenatal anatomical variants of the fetal digestive tract, and interobserver agreement on prenatal ultrasound.


Eligibility criteria: Inclusion Criteria:

* Pregnant women over the age of 18
* Good understanding of French
* Gestational age greater than or equal than 31 weeks
* Fetal MRI indication validated in multidisciplinary staff at weekly meetings of the Multidisciplinary Prenatal Diagnosis Center in Montpellier or Nimes
* Affiliation or beneficiary of a social security scheme
* Declaration of free and enlightened opposition

Exclusion Criteria:

* Complex fetal abdominal malformations responsible for difficult interpretation of imaging: heterotaxis with asplenia or polysplenium, diaphragmatic hernia, omphalocele, gastroschisis, digestive pathology, abdominal tumor, bladder exstrophy or megavessia.
* Fetal chromosomal abnormality
* Request for termination of pregnancy validated by a Multidisciplinary Pre-natal Diagnosis Center

Primary outcomes:
measure: Ultrasound localization of intestinal structure (mesenteric vessels, small bowel, gut)
timeFrame: At the visit 1 of the subjects
Secondary outcomes:
measure: normal meconium progression
timeFrame: At the visit 1 of the subjects
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Florent FUCHS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00276107: Study Evaluating Prevenar Vaccine in Healthy Infants
Official title: An Open-Label Trial of the Immunogenicity and Safety of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine [Diphteria CRM197 Protein Conjugate]) in Healthy Infants at 2, 4 and 6 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumococcal Infections
Keywords: Vaccine
Healthy Infants
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-12
Enrollment: 200
Sex: ALL
Minimum age (years): 42
Maximum age (years): 100
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age. To determine the antibody responses to the seven pneumococcal vaccine serotypes one month after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6 months of age.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female children 2 months of age (42 to 100 days) in good health.
* An informed consent must be signed by a parent or legal guardian following a detailed explanation of participation in the study.
* Infants whose parent(s)/guardian(s) will be available for the entire study period.

Exclusion Criteria:

* Hypersensitivity to any component of the vaccine, including diphtheria toxoid
* Infants with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
* Infants with known or suspected impairment of immunologic functions including HIV or those receiving immunosuppressive therapy.

Other exclusions apply.

Primary outcomes:
measure: To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age
Secondary outcomes:
measure: To determine the antibody responses to the seven pneumococcal vaccine serotypes after second dose and to determine the safety of Prevenar in infants immunized at 2, 4 and 6 months of age
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: