louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00779090: Functional Residual Capacity (FRC) Guided Alveolar Recruitment Strategy
Official title: The Influence of a Functional Residual Capacity Guided Alveolar Recruitment Strategy After Open Endotracheal Suctioning on Oxygenation and Regional Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ventilation
Functional Residual Capacity
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In ventilated patients open endotracheal suctioning may lead to alveolar derecruitment, which can be monitored by means of functional residual capacity (FRC) measurements. The investigators hypothesized that a recruitment strategy based on FRC measurements would improve oxygenation and regional ventilation after an open endotracheal suctioning manoeuvre.

Detailed description: In mechanically ventilated patients the functional residual capacity will be measured before (baseline) and after an open endotracheal suctioning manoeuvre. Based on these changes patients will be divided into two groups: Group A with more than 94% of baseline FRC, and Group B with less than 94% of baseline FRC. Both groups will be randomized to receive an alveolar recruitment manoeuvre or no alveolar recruitment manoeuvre, leading to four groups. Oxygenation and regional ventilation with electrical impedance tomography will be studied.

Eligibility criteria: Inclusion Criteria:

* ventilated after elective cardiac surgery

Exclusion Criteria:

* hemodynamic instability (eg. intraaortic balloon pump)
* acute lung injury, i.e. PEEP \> 10cmH20 or FiO2 \> 0.4

Primary outcomes:
measure: Arterial oxygenation
timeFrame: 60 minutes
Secondary outcomes:
measure: Regional ventilation
timeFrame: 60 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anaesthesiology, University of Lübeck
name: Hermann Heinze, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heinze H, Eichler W, Karsten J, Sedemund-Adib B, Heringlake M, Meier T. Functional residual capacity-guided alveolar recruitment strategy after endotracheal suctioning in cardiac surgery patients. Crit Care Med. 2011 May;39(5):1042-9. doi: 10.1097/CCM.0b013e31820eb736.
Clinical trial NCT03121703: The Effects of Lumbar Stabilization Exercise on Transversus Abdominis Muscle Activation Capacity and Function in Chronic Low Back Pain Patients
Official title: Main Researcher for Effects of Lumbar Stabilization Exercise on Transversus Abdominis Muscle Activation Capacity and Function in Chronic Low Back Pain Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: The purpose of this study is to investigate the effects of lumbar stabilization exercises on pain intensity, transversus abdominis muscle (TrA) activation capacity, functional disability, and TrA thickness in patients with chronic low back pain (CLBP). Subjects: The subjects of this study were 30 CLBP patients. Methods: The experimental group performed diverse lumbar stabilization exercises in different postures, and the control group conducted an ordinary trunk muscle strengthening exercise. Results: There were significant differences in pain intensity, TrA activation capacity, functional disability, and TrA thickness between before and after the intervention in both groups. Significant differences between the two groups were shown in the pain intensity, TrA activation capacity, and functional disability after the intervention. However, there were no significant differences between the two groups in TrA thickness. Conclusion: Lumbar stabilization exercises in different postures could reduce pain, functional disability, and increase TrA activation capacity and thickness in CLBP patients.


Eligibility criteria: Inclusion Criteria:

* patients who felt low back pain

Exclusion Criteria:

* Orthopedic surgery within 6 months

Primary outcomes:
measure: transverse abdominis thickness
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02475603: Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty
Official title: Clinical, Biochemical and Neurophysiological Consequences of Intraoperative
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscles Ischemia
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty:

WOMAC-Score Knee-Score Radiographic Evaluations and Scoring System Biochemical muscle biopsy analysis

Detailed description: Biochemistry: Analysis of the muscles biopsies Clinical: Bloodloss, Complications, WOMAC-Score, Knee-Score Radiographics: Evaluations and Scoring System Neurophysiology Evaluation of N. femoralis

Eligibility criteria: Inclusion Criteria:

* Age = 55-85 years
* Osteoarthritis of knee joint (degree III or IV)
* Physical status (ASA I or II)
* Body mass index \< 45 kg/m²
* Written informed consent

Exclusion Criteria:

* Age \<55 or \> 85years
* Osteoarthritis knee joint (degree I or II)
* Physical status (ASA III or IV)
* Body mass index ≥ 45 kg/m²
* Unable to provide written consent
* Malignant disease
* Rheumatoid disease
* Infectious disease
* Coagulation disorder
* History of deep vein thrombosis or pulmonary embolism
* Peripheral arterial disease
* Immune deficiency
* Medication (Glucocorticoid, Aspirin, Heparin, Cumardine, Wafarin)
* Neurological dysfunction
* Liver insufficiency
* Coronary heart disease
* Immobility

Primary outcomes:
measure: Biochemical Data
timeFrame: During operation 60 min Ischemia/Shame-Ischemia Time
Secondary outcomes:
measure: Bloodloss
timeFrame: 1 week postoperative
measure: Complications
timeFrame: 6 months postoperative
measure: Clinical Scores
timeFrame: 6 months postoperative
measure: Radiographic Scores
timeFrame: 1 Week postoperative
measure: Electrophysiological Evaluation of the N. femoralis
timeFrame: 1 Week postoperative
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: UMM
state: Badenwürtemberg
Study officials:
affiliation: UMM
name: Udo Obertacke, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Girard N. Evidence appraisal of Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of a tourniquet used in total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2014;9(1):13. http://www.josr-online.com/content/9/1/13. Accessed May 30, 2014. AORN J. 2014 Aug;100(2):224-8. doi: 10.1016/j.aorn.2014.06.003. No abstract available.
citation: Jawhar A, Skeirek D, Stetzelberger V, Kollowa K, Obertacke U. No effect of tourniquet in primary total knee arthroplasty on muscle strength, functional outcome, patient satisfaction and health status: a randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2020 Apr;28(4):1045-1054. doi: 10.1007/s00167-019-05646-5. Epub 2019 Aug 1.
Clinical trial NCT02886403: Evaluation of the Influence of Output on a Newly Develop Adhesive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2016-09-01
Enrollment: 5
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: The study investigates the impact real output has on the adhesion of adhesives.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation

Primary outcomes:
measure: Peel force used to removed the adhesive from the skin
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: R&D scientist
name: Lene F Nielsen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01157403: Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes
Official title: Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Evidence of Liver Transplantation
Keywords: mesenchymal stem cells
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2010-07-07
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells; as a result, patients with T1DM are dependent on exogenous insulin to control their blood glucose continuously. Bone marrow-derived mesenchymal stem cells has been shown in many animal studies their potential cure for T1DM,which could not only address the need for β-cell replacement but also control of the autoimmune response to cells which express insulin. Therefore it is need to study the safety and efficacy of autologous bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.

Detailed description: Autologous transplantation of Bone marrow mesenchymal stem cells(approximately 2.5 x 106 cells/kg body weight) intravenously

Eligibility criteria: Inclusion Criteria:

1. Ability to provide written informed consent from patients or Child guardian
2. Confirmed diagnosis of type 1 diabetes by ADA criteria less than 18 weeks •

Exclusion Criteria:

1. Body Mass Index \>30
2. Presence of acute stage as Active infection,recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
3. Severe Organ damage(e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
4. Infectious diseases, e.g. HIV infection, or hepatitis B or C infection
5. Presence of malignancy

Primary outcomes:
measure: C peptide release test
timeFrame: 6 Months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Endocrine Department, the south west Hospital of the Third Military Medical University
state: Chongqing
Study officials:
affiliation: Endocrine Department, the south west Hospital of the Third Military Medical University
name: chen bing, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01937403: Sport Cord Test Following ACL Reconstruction
Official title: The Use of the Sport Cord Test as a Measure of Physical Performance Following Anterior Cruciate Ligament Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Injury of Anterior Cruciate Ligament
Keywords: Physical Therapy
Return to sport
Lead sponsor: The Hawkins Foundation
Sponsor class: OTHER
First posted: 2013-09-09
Enrollment: 171
Sex: ALL
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving physical therapy/rehabilitation for an ACL surgery and are returning to participation in sports.

Brief summary: The primary purpose of this study is to determine the interrater reliability and validity of the Sportcord Test as a measure of physical performance following anterior cruciate ligament (ACL) reconstruction. A secondary purpose is to systematically track subjective and objective outcomes on patients following ACL reconstruction to help identify differences between those who have subsequent knee problems and those who do not. The study hypotheses are the following:

1) The Sportcord Test will provide a valid and reliable measure of functional performance following ACL reconstruction. 2) Patients who have subsequent knee problems in the 12 month study period will exhibit different scores on clinical special tests compared to those who do not.


Eligibility criteria: Inclusion Criteria:

* Undergoing surgical reconstruction for a torn ACL.
* Returning to participation in a sport(s).
* Will receive physical therapy/rehabilitation after surgical reconstruction for a torn ACL.
* Between ages of 10 and 50.

Exclusion Criteria:

* Non-weight bearing.
* At least 12 weeks removed from surgery.
* Unable to walk, squat, or jump/land without pain in the surgically repaired knee.

Primary outcomes:
measure: Sportcord Test
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: ATI Physical Therapy
state: South Carolina
Study officials:
affiliation: ATI Physical Therapy
name: Ellen Shanley, PT, PhD, OCS, CSCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01304303: Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor in Advanced Stage
Keywords: solid
tumor
taxane
platinum
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2011-02-25
Enrollment: 57
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: Phase I study of SPARC1023 alone and in combination with carboplatin

Detailed description: Pharmacokinetic profile and dose escalation study of SPARC1023 when administered as 30-min infusion.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* ECOG Performance Status ≤ 1.
* Estimated life expectancy of at least 12-weeks;
* Measurable disease as per RECIST guideline (Version 1.1);

Exclusion Criteria:

* Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer
* Known hypersensitivity to the study drugs
* Treatment with any anti-cancer agents within 28 days of study entry
* Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or radiation therapy

Primary outcomes:
measure: Determination of MTD
timeFrame: One 21-day treatment cycle
Secondary outcomes:
measure: Establishing the pharmacokinetic profile
timeFrame: One 21-day treatment cycle
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: SPARC Site 1
state: New York
Study officials:
References:
Clinical trial NCT04095403: Tarp Assisted Cooling of Hyperthermic Individuals
Official title: Tarp Assisted Cooling of Hyperthermic Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Heat
Cooling
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial exploring the difference in cooling rates between two treatments: 1) tarp-assisted cooling and 2) the standard of care for heat stroke treatment in the wilderness.

Detailed description: This is a randomized controlled trial exploring the difference in cooling rates between two treatments: 1) tarp-assisted cooling and 2) the standard of care for heat stroke treatment in the wilderness. 12 healthy participants (6 males, 6 females) will participate. Visit 1 will be a screening visit, consisting of informed consent followed by completion of questionnaires to determine study eligibility. Participants will have their resting vital signs (heart rate, blood pressure), height, weight, and percent body fat measured. Visits 2 and 3 will be experimental trials. Participants will complete a treadmill protocol consisting of brisk walking wearing a weighted backpack (40 lb) until core temperature reaches 40.0°C. Upon completion of exercise, participants will exit the environmental chamber and be cooled in one of two ways in a randomized, counterbalanced manner: 1) tarp-assisted cooling or 2) Standard of Care. Cooling will take place for 20 minutes.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Aerobic exercise at least twice weekly

Exclusion Criteria:

* History of exertional heat illness

Primary outcomes:
measure: Cooling Rate
timeFrame: 20 minutes post-exercise.
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Center for Research and Exercise in Special Environments
state: New York
Study officials:
affiliation: University at Buffalo
name: Riana R Pryor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06322303: Effect of Cannabidiol (CBD) on Vision and Driving
Official title: Effect of Cannabidiol (CBD) Consumption on Visual Function and Driving Performance
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Cannabis Use
Keywords: cannabis
cannabidiol
vision
driving performance
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The use of cannabis with ∆9-tetrahydrocannabinol (THC) content has been shown to have negative effects on vision and driving. The use of other cannabinoids, such as cannabidiol (CBD), which is not attributed with a psychoactive effect, is increasing significantly. This project aims to investigate whether consuming CBD can negatively affect visual function by assessing a wide range of visual parameters and whether these changes may pose a risk for everyday activities such as driving.


Eligibility criteria: Inclusion Criteria:

* Being an occasional cannabis and/or cannabidiol user
* Have a current driving licence
* Have at least one year's driving experience
* Drive at least once a week
* Monocular visual acuity of at least 6/6 (Snellen) with habitual correction for driving
* Absence of binocular disorders

Exclusion criteria:

* Certain past or present medical conditions
* Current cannabis or alcohol use disorder
* Use of other drugs
* Pregnancy or lactation
* Simulator sickness.

Primary outcomes:
measure: Change in Overall Driving Performance Score (ODPS) after cannabidiol vaporization
timeFrame: Participants are assessed 20 minutes after vaporization
measure: Change in motion detection sensitivity after cannabidiol vaporization
timeFrame: Participants are assessed 20 minutes after vaporization
measure: Change in contrast sensitivity after cannabidiol vaporization
timeFrame: Participants are assessed 20 minutes after vaporization
measure: Change in visual acuity after cannabidiol vaporization
timeFrame: Participants are assessed 20 minutes after vaporization
measure: Change in fixations after cannabidiol vaporization
timeFrame: Participants are assessed 20 minutes after vaporization
Secondary outcomes:
measure: Driving simulator: standard deviation of the lateral lane position (SDLP)
timeFrame: Participants are assessed 20 minutes after vaporization
measure: Distance travelled outside the lane
timeFrame: Participants are assessed 20 minutes after vaporization
measure: Mean speed
timeFrame: Participants are assessed 20 minutes after vaporization
measure: Angular velocity of the steering wheel
timeFrame: Participants are assessed 20 minutes after vaporization
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
References:
Clinical trial NCT03890003: A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes
Official title: An Early Feasibility Study to Evaluate the Predictive Low Glucose Suspend Functionality and Safety in an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-03-26
Enrollment: 10
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: DEVICE_FEASIBILITY

Brief summary: The purpose of this early feasibility study is to assess the predictive low glucose suspend (PLGS) feature's safety, functionality and performance.


Eligibility criteria: Inclusion Criteria:

* Participants with T1DM for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months
* Have a body mass index of 18.5 to 37 kilogram per meter squared
* Have a hemoglobin A1c level ≥6.0% and ≤9.0%

Exclusion Criteria:

* Have known allergies or history of hypersensitivity to insulin lispro
* Have had an episode of severe hypoglycemia within the past 6 months
* Have had more than 1 episode of diabetic ketoacidosis in the past 6 months

Primary outcomes:
measure: Number of Adverse Events (AEs)
timeFrame: In-Patient Period (2 Days)
measure: Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL
timeFrame: In-Patient Period (2 Days)
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Pinsker JE, Bartee A, Katz M, Lalonde A, Jones R, Dassau E, Wolpert H. Predictive Low-Glucose Suspend Necessitates Less Carbohydrate Supplementation to Rescue Hypoglycemia: Need to Revisit Current Hypoglycemia Treatment Guidelines. Diabetes Technol Ther. 2021 Jul;23(7):512-516. doi: 10.1089/dia.2020.0619. Epub 2021 Feb 18.