louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04211246: Oxygen Reserve Index to Reduce Hyperoxia
Official title: Efficacy of Oxygen Reserve Index (ORI) to Reduce Hyperoxia in Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperoxemia
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Excessive oxygen administration is known to cause oxidative stress, and absorption atelectasis. Hyperoxia is very common in general anesthesia settings. Even though there are concerns in using excessive oxygen during general anesthesia, the optimal fraction of inspired oxygen (FiO2) for general anesthesia is not well studied.

The oxygen reserve index (ORI) is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORI that it might be helpful to reduce hyperoxia in critically ill patients in the intensive care unit, as well as in general anesthesia.

The aim of this study is to evaluate efficacy of oxygen reserve index to reduce hyperoxemia in major abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective major abdominal surgery expected to last more than 2hours.
* Patients who are scheduled for invasive arterial cannulation during surgery.

Exclusion Criteria:

* Abnormal pulmonary function test
* Pregnancy
* Saturation of oxygen (SpO2) is below 92% in room air

Primary outcomes:
measure: Pressure of arterial oxygen (PaO2) after 1 hour of surgery.
timeFrame: After 1 hour of surgery
Secondary outcomes:
measure: Pressure of arterial oxygen (PaO2) after 2 hours of surgery.
timeFrame: After 2 hours of surgery
measure: Pressure of arterial oxygen (PaO2) after 3 hours of surgery.
timeFrame: After 3 hours of surgery
measure: Minimal and maximal value of PaO2 throughout the surgery
timeFrame: 1 hour after the end of surgery
measure: Fraction of inspired oxygen (FiO2)
timeFrame: 1 hour after the end of surgery
measure: Oxygen reserve index (ORI)
timeFrame: 1 hour after the end of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
References:
citation: Ahn JH, Shim JG, Park J, Lee SH, Ryu KH, Cho EA. Oxygen reserve index guided fraction of inspired oxygen titration to reduce hyperoxemia during laparoscopic gastrectomy: A randomized controlled trial. Medicine (Baltimore). 2022 Nov 18;101(46):e31592. doi: 10.1097/MD.0000000000031592.
Clinical trial NCT03063346: The Effect of a Protein Hydrolysate on Muscle Strength Recovery
Official title: The Effect of a Protein Hydrolysate on Muscle Strength Recovery in Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Strength Recovery
Lead sponsor: BioActor
Sponsor class: INDUSTRY
First posted: 2017-02-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Overtraining is a real problem for (semi-)professional athletes. Overtraining is often caused by the bodies' lack of ability to recover between training. In addition, during high intensity training reactive oxygen species are formed up to 20 fold compared to resting values. This causes increased muscle tissue damage after intense exercise, which slows down recovery. Improving recovery may increase an athlete's ability to reach higher training volumes resulting in establishing a higher performance plateau.

It is known that hydrolyzed proteins have a positive effect on muscle protein synthesis due to its faster absorption rate. Therefore, it is hypothesized that a known protein hydrolysate may have positive effects on strength recovery.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals (based on their medical history provided during a general health questionnaire)
* Participants are amateur or (semi-) professional athletes in resistance or interval sports (engage in \>6 hours of intense physical activity per week).
* Age 18 - 35
* Experience in resistance training

Exclusion Criteria:

* Use of creatine supplements and/or anabolic steroids.
* Allergy to test product/protein
* Allergy to specific protein hydrolysate
* BMI lower than 18 or higher than 30.
* Lack of technique in correctly performing a barbell squat (judged by sports physiologist).
* Recent muscle injury in legs or back less than one month before the start of the study.
* Cardiovascular complications
* Use of medication
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study.
* Abuse of products; alcohol (\> 20 alcoholic units per week) and drugs

Primary outcomes:
measure: Muscle strength recovery
timeFrame: 4 weeks
Secondary outcomes:
measure: Blood lactate buildup
timeFrame: 4 weeks
measure: Body composition
timeFrame: 4 weeks
measure: Exercise volume
timeFrame: 4 weeks
measure: Peak force output
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03734146: Independent and Combined Effects of Aerobic and Resistance Training on Blood Pressure
Official title: Independent and Combined Effects of Aerobic and Resistance Training on Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 69
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: BASIC_SCIENCE

Brief summary: We compared the effects of 8 weeks of aerobic exercise only, resistance exercise only, or a combination of both on blood pressure in overweight or obese middle-aged adults with elevated blood pressure. Participants engaged in supervised exercise sessions 3 times per week for 60 minutes each session. Outcomes were assessed at baseline and after the 8-week intervention. Extra-intervention physical activity and diet were also assessed.


Eligibility criteria: Inclusion Criteria:

* Systolic/diastolic blood pressure of 120-159/80-99 mm Hg
* Non-smoking
* Overweight or obese, with a body mass index of 25-40 kg/m2
* Inactive--not meeting the aerobic or resistance physical activity guidelines, which means engaging in less than 150 minutes/wk of moderate intensity aerobic exercise and less than 2 days per week of resistance training over the past 3 months.

Exclusion Criteria:

* Unstable coronary heart disease or decompensated heart failure
* Severe pulmonary hypertension or aortic stenosis
* Acute myocarditis, endocarditis, pericarditis, or aortic dissection
* Other medical condition that is life-threatening or that can interfere or be aggravated by the exercise training such as cancer, uncontrolled diabetes, severe pain or mobility limitations.
* Premenopausal women or postmenopausal women taking hormonal replacement therapy
* Pregnant women or anticipated pregnancy via IVF or other medical procedures during the course of the intervention

Primary outcomes:
measure: Change in resting blood pressure
timeFrame: Immediately before and after the 8 week intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Iowa State University
name: Duck-chul Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01879046: Regenerative Medicine of Articular Cartilage: Characterization and Comparison of Chondrogenic Potential and Immunomodulatory Adult Mesenchymal Stem Cells
Official title: Regenerative Medicine of Articular Cartilage: Characterization and Comparison of Chondrogenic Potential and Immunomodulatory Adult Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Mesenchymal stem cells
articular cartilage
tissue engineering
immunomodulation
osteo-arthritis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Articular cartilage can be the seat of many diseases including osteoarthritis and traumatic defaults. The cartilage has no intrinsic ability to repair resulting at long term in function loss in the joints. Currently available treatments are not satisfactory in the long term, the use of mesenchymal stem cells appears to be promising due to their ability to multipotency and immunomodulation properties. This project aims to determine the most appropriate source for regenerative medicine of cartilage stem cells from tissue taken during arthroplasty in patients with osteoarthritis. These cells will be tested for different chondrogenic markers. The success of this project will consider the implementation of a strategy for regenerative medicine in bone and joint diseases.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years
* Patients with knee osteoarthritis
* Patients requiring total knee arthroplasty
* Patients who signed the consent form

Exclusion Criteria:

* Patients aged less than 18 years
* Major Patients under guardianship
* Pregnant woman
* Infectious pathology or progressive tumor
* Refusal to participate in the study
* State of immunosuppression
* Congenital or acquired malformation resulting in a deformation of the knee

Primary outcomes:
measure: Increased expression of chondrogenic markers
timeFrame: up to 3 years
Secondary outcomes:
measure: Increasing secretion of anti-inflammatory molecules in vitro
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Dr Ronan Guillou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00519246: Comparison of Pain Therapeutic Effects After Benign Mastectomy
Official title: Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Mastectomy
Keywords: Breast Neoplasms
Non-Steroidal Anti-Inflammatory Agents
Analgesia
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2007-08-22
Enrollment: 2000
Sex: FEMALE
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: With the incremental trend of benign breast tumor, the surgical process of mastectomy was proceeded too much every day, especially in the Maternal Health Care Hospital, but whether the investigators can find another way to relieve the postoperative pain after such an operation is still unknown. The investigators hypothesized that the pain from the relatively small surgery may not be significant compared to different treatments, even if no drug was delivered to them. The investigators are enrolling patients who underwent mastectomy from benign breast tumor, and are observing the analgesic effects of different drugs.


Eligibility criteria: Inclusion Criteria:

* Chinese
* No cardiac and pulmonary diseases
* ASA I-II
* No alcohol drinking.

Exclusion Criteria:

* \<19yrs, and \>65yrs
* History of central active drugs administration
* Drug abuse
* Hypertension
* Diabetes
* Any other chronic diseases.

Primary outcomes:
measure: Visual analog scale (VAS) rating of pain
timeFrame: 0-24h after surgeries
Secondary outcomes:
measure: VAS rating of sedation
timeFrame: 0h to 24h after the end of the operation
measure: Overall VAS rating of satisfaction with analgesia
timeFrame: 24 h after operation
measure: Incidence of side effects
timeFrame: From the initiation of analgesia (0 h) to the end of the study (24 h postoperative)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_CHAIR
References:
citation: Shen X, Wang F, Xu S, Ma L, Liu Y, Feng S, Wang W, Zhao Q, Li X, Zhao L, Yao X, Qu J, Xie B, Wang H, Yuan H, Cao Y, Sun Y, Wang W, Guo L, Song Z, Wang Z, Guan X. Comparison of the analgesic efficacy of preemptive and preventive tramadol after lumpectomy. Pharmacol Rep. 2008 May-Jun;60(3):415-21.
Clinical trial NCT06412146: Children's Mercy Teens with Type 1 Diabetes Will Participate in an Online Peer Support Group.
Official title: Diabetes Link Discord
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this observational study is to examine the impact of an online peer support group in Children's Mercy teens with Type 1 Diabetes.

The main objectives are to examine the feasibility and acceptability of the Diabetes Link's online social platform Discord among youth with diabetes as it relates to peer support, diabetes management, and usability and to examine the efficacy/magnitude of the effect of the Discord group on treatment adherence among youth with diabetes.

Participants will participate in an online peer support group for 3 months and provide their feedback while doing so.


Eligibility criteria: Inclusion Criteria:

* T1D Diagnosis
* 16-19 years old
* 11th-12th graders
* Access to smartphone/laptop
* English-speaking

Primary outcomes:
measure: Discord User Metrics
timeFrame: 3 months
measure: Final Feedback Survey
timeFrame: 3 months
Secondary outcomes:
measure: Diabetes Measures
timeFrame: 3 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
References:
Clinical trial NCT02859246: Mucinex® for Treatment of Filamentary Keratitis
Official title: Mucinex® for Treatment of Filamentary Keratitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Filamentary Keratitis
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 15
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: TREATMENT

Brief summary: It is a pilot study aimed to determine if oral Mucinex® is effective in reducing the amount of corneal filaments and improving symptomology in subjects with filamentary keratitis.

Detailed description: The study is aimed to determine if oral administration of Mucinex® is effective in reducing the amount of corneal filaments and improving symptomology in subjects with filamentary keratitis. Subjects will be instructed to take 600 mg tablets of extended release Mucinex® twice a day (total dose is 1.2 g/day) for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with filamentary keratitis
* 18 years and older

Exclusion Criteria:

* Active ocular surface infection of any type
* Recent ocular surgery (\<30 days) history of nephrolithiasis as Mucinex® has been associated in rare cases of development of kidney stones
* Schirmer's test\<3mm
* History of hypersensitivity to Mucinex®
* Concurrent eye disease requiring immediate initiation of a new treatment (e.g. topical steroids) restriction for water intake can exacerbate the risk of nephrolithiasis.

Primary outcomes:
measure: Change in Number of Corneal Filaments
timeFrame: baseline (day 1) and week 4
Secondary outcomes:
measure: Change in OSDI Score
timeFrame: baseline (day 1) and week 4
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear Infirmary
name: Reza Dana, M.D,MPH,M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06880146: Cross-validation of a Predictive Model of Response to Anti-TNF Alpha Based on Oxylipin Response in Rheumatoid Arthritis
Official title: Cross-validation of a Predictive Model of Response to Anti-TNF Alpha Based on Oxylipin Response in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid, arthritis
Oxylipin
Cytokin
EULAR response
Polyunsaturated fat
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Unité de Nutrition Humaine, INRAE, Centre Auvergne-Rhône Alpes
name: Immunology department, CHU Clermont-Ferrand
name: University of Southampton, Southampton, United Kingdom
First posted: 2025-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohort study
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to use a blood test to predict whether a participant diagnosed with rheumatoid arthritis will respond to anti-TNF alpha treatment . The main questions it aims to answer is:

Is the predictive model created using oxylipins effective?

Participants starting anti-TNF alpha treatment will have a blood sample taken before starting treatment and 6 months afterwards.


Eligibility criteria: Inclusion Criteria:

* Male or female patient aged 18 years or older with rheumatoid arthritis according to ACR EULAR 2010 criteria
* Active disease as defined by DAS-28-CRP\>3.2
* Naive to targeted biologic or synthetic therapy
* Rheumatologist's decision to start anti-TNFα treatment
* Stable corticosteroid therapy ≤ 10 mg/day
* Patient enrolled in or benefiting from a social security scheme
* Patient who has given written informed consent to participate in the study

Exclusion Criteria:

* Contraindication to biological treatment (cancer or history of cancer)
* Treatment with non-steroidal anti-inflammatory drugs in the 2 weeks prior to enrolment
* Protected persons (pregnant and/or breastfeeding women, persons under guardianship or conservatorship)

Primary outcomes:
measure: Whole Blood Oxylipin Response (WBOR)
timeFrame: Month 0
measure: EULAR clinical response
timeFrame: Month 6
Secondary outcomes:
measure: Performance of the predictive response model
timeFrame: Month 0
measure: Polyunsaturated fat (PUFA) content of blood cells
timeFrame: Month 0
measure: Polyunsaturated fat (PUFA) content of blood cells
timeFrame: Month 6
measure: Cytokine response
timeFrame: Month 0
measure: Cytokine response
timeFrame: Month 6
measure: Whole Blood Oxylipin Response (WBOR)
timeFrame: Month 6
Other outcomes:
Locations:
city: Clermont-ferrand
country: France
facility: CHU Clermont-Ferrand
city: Paris
country: France
facility: Hopital Cochin, APHP
city: Saint-Etienne
country: France
facility: CHU Saint Etienne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Anne TOURNADRE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00055146: Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)
Official title: A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, Lymphocytic, Chronic
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2003-02-21
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously treated patients with chronic lymphocytic leukemia (CLL)


Eligibility criteria: Inclusion Criteria:

* Patients with B-cell Chronic Lymphocytic Leukemia, Rai Stage 0-II with indication for treatment by NCI Working Group Criteria or Rai Stage III or IV.
* Patients must have received at least one prior purine analogue-based chemotherapy regimen.
* ECOG Performance Status of 0, 1, or 2.
* Female patients cannot be pregnant and must use birth control during the course of the study and for three weeks after the study ends.

Exclusion Criteria:

* Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-2.
* Received any therapy for CLL within 35 days prior to study entry.

Primary outcomes:
measure: Objective Clinical Response
Secondary outcomes:
measure: Time-to-Progression
measure: Duration of response
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Pacific Coast Hematology/Oncology Medical Group, Inc.
state: California
city: La Jolla
country: United States
facility: UCSD School of Medicine
state: California
city: Chicago
country: United States
facility: Rush-Presbyterian St. Luke's Cancer Center
state: Illinois
city: New York
country: United States
facility: Weill Medical College of Cornell University/New York Presbyterian Hospital
state: New York
city: Houston
country: United States
facility: University of Texas, M.D. Anderson Cancer Center
state: Texas
city: Mendoza
country: Argentina
facility: Montecaseros
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Institute
state: Victoria
city: Frankston
country: Australia
facility: Oncology Day Unit, Frankston Hospital
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias
state: GO
city: Curitiba
country: Brazil
facility: Hospital de Clinicas da Universidade Federal do Parana
state: PR
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro - Hospital Universitario Clementino Fraga Filho
state: RJ
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos - Fundacao Pio XII
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
state: SP
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis - Jewish General Hospital
state: Quebec
Study officials:
affiliation: Ligand Pharmaceuticals
name: Elyane Lombardy, M.D.
role: STUDY_DIRECTOR
References: