louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05809947: Mechanisms of Tissue Repair After Muscle Injury and Tendon Strain
Official title: Regulation of Human Tendon and Skeletal Muscle Protein Turnover Following Tissue Injury: Mechanisms Behind Regeneration and Injury Preventive Adaptations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle; Injury, Quadriceps (Thigh)
Tendon Strain
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study is a 5-week human study including 24 18-35 year old healthy men. Each participant will have muscle injury and tendon strain induced in one leg using neuromuscular electrical stimulation in conjunction with forced lengthening contractions. The investigators will monitor the recovery from injury/strain over a 4 week period, in which half of the subjects will receive growth hormone (somatropin) to stimulate the connective tissue synthesis.


Eligibility criteria: Inclusion Criteria:

* Healthy men
* BMI between 18.5-30 kg/m\^2

Exclusion Criteria:

* Smoking
* Regular strength training within the last 3 months
* Current or former use of anabolic steroids or growth hormone
* Use of corticosteroids in the last 3 months
* Use of blood thinning medication
* Use of medication which can affect muscle protein synthesis
* Current or former drug og alcohol abuse
* Knee pain
* Previous participation in studies using deuterated water or alanine tracers

Primary outcomes:
measure: Effect of somatropin on muscle protein synthesis 14 days after injury
timeFrame: 14 days
Secondary outcomes:
measure: Muscle protein synthesis 7 days after injury
timeFrame: 7 days
measure: Muscle protein synthesis 14 days after injury
timeFrame: 14 days
measure: Muscle protein breakdown 14 days after injury
timeFrame: 14 days
measure: Muscle protein breakdown 7 days after injury
timeFrame: 7 days
measure: Muscle protein breakdown 28 days after injury
timeFrame: 28 days
measure: Histochemical staining of muscle cross sections 7 days after injury
timeFrame: 7 days
measure: Histochemical staining of muscle cross sections 14 days after injury
timeFrame: 14 days
measure: Histochemical staining of muscle cross sections 28 days after injury
timeFrame: 28 days
measure: The effect of somatropin on tendon tissue synthesis
timeFrame: 7 days
measure: Tendon tissue synthesis 7 days after strain
timeFrame: 7 days
measure: Tendon tissue synthesis 7 days after strain with/without somatropin
timeFrame: 7 days
measure: Isometric muscle force output 7 days following injury
timeFrame: 7 days
measure: Isometric muscle force output 14 days following injury
timeFrame: 14 days
measure: Isometric muscle force output 28 days following injury
timeFrame: 28 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sports Medicine Copenhagen
Study officials:
References:
Clinical trial NCT02247947: Proteomics to Identify Prognostic Markers After CPR and to Estimate Neurological Outcome
Official title: Proteomics to Identify Prognostic Markers After CPR and to Estimate Neurological Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: CPR
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with cardiac arrest of non-trauma origin

Brief summary: Proteomics is used to identify prognostic markers after CPR. Additionally neurological outcome should be estimated by specific protein alterations and affections of pathways.

Detailed description: Proteomics is used to identify prognostic markers after CPR, i.e. altered proteins on a 2G-gel. Additionally neurological outcome should be estimated by specific protein alterations and affections of pathways.

Eligibility criteria: Inclusion Criteria:

* cardiac arrest

Exclusion Criteria:

* trauma

Primary outcomes:
measure: death at day 20
timeFrame: day 20
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
state: NRW
Study officials:
affiliation: UK Köln
name: Jochen Hinkelbein, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06515847: Comfort and Quality of Life of Patients at the End of Life
Official title: A Study to Evaluate The Effects Of Nursing Care İmplementations Based On Kolcaba's Comfort Theory For The End Of Life Patients Comfort Levels and The Life Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End of Life
Keywords: Comfort
nurse
care
Lead sponsor: Fenerbahce University
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental study
Primary purpose: SUPPORTIVE_CARE

Brief summary: A Research to Evaluate the Effect of Nursing Care Practices Based on Kolcaba's Comfort Theory on the Comfort Levels and Quality of Life of End-of-Life Patients.

Purpose: The study was carried out as a semi-experimental posttest with independent groups and a control group, in order to determine the effect of nursing care interventions on the patient's quality of life comfort level, based on Kolcaba's comfort theory. end-of-life patients.

Materials and Methods: This study compared 30 experimental and 30 control patients, aged between 25-70, at least primary school graduate, staying in the palliative care unit. He used the unit for at least two weeks and agreed to be part of this study. While the patients in the experimental group were cared for according to the nursing care plan based on Kolcaba's comfort theory, the patients in the control group were treated with the institution's standard care plan. The results were evaluated according to the standard comfort scale and the general quality of life scale.


Eligibility criteria: Inclusion Criteria:

* between 25-70 years old,
* communicable,
* at least primary school graduates,
* hospitalized in the unit for at least 2 weeks, and who agreed to participate in the study were included in the study.

Exclusion Criteria:

* All patients who did not meet the inclusion criteria and patients who were included in the study but died within 2 weeks were excluded from the study.

Primary outcomes:
measure: Kolcaba's comfort theory
timeFrame: 2 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fenerbahce University
Study officials:
References:
Clinical trial NCT03557047: Perioperative Mechanism of Acute Kidney Injury in Cardiovascular Surgery
Official title: Preliminary Study on the Pathogenesis of Acute Kidney Injury After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pathogenesis
Acute Kidney Injury
Cardiac Surgery
Lead sponsor: The First Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Perioperative data were collected, including cardiopulmonary bypass time，aortic cross-clamping time, operative time, extubation time, ICU time and hospital stay.

Brief summary: Continuous observation of acute renal injury after cardiac surgery, at the same time retention of blood samples, to test indicators，and to select the research route from the clinical actual test results .


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing selective cardiac surgery, aged between 18 and 80.

Exclusion Criteria:

* Normal range of creatinine before operation

Primary outcomes:
measure: Incidence of acute renal injury after cardiac surgery
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
References:
Clinical trial NCT06920147: PRevention Of Trauma-related Infections Through an Embedded Clinical Trials Network
Official title: PRevention Of Trauma-related Infections Through an Embedded Clinical Trials (PROTECT) Network
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Surgical Site Infection
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Surgical Infection Society
First posted: 2025-04-09
Enrollment: 300
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: The purpose of this study is to compare the effectiveness of 2 prophylactic antibiotic regimens, ertapenem and cefazolin with metronidazole, in preventing organ space surgical site infections (OS-SSI) after emergency trauma laparotomy embedded into routine clinical care and to validate a Bayesian OS-SSI risk calculator using Trauma Quality Improvement Program (TQIP) standardized variables


Eligibility criteria: Inclusion Criteria:

* Trauma laparotomy within 90 minutes of arrival

Exclusion Criteria:

* Patients with a known allergy to cephalosporins or β-lactamase inhibitors
* Prisoners
* Pregnant and lactating women

Primary outcomes:
measure: Number of participants that have post-laparotomy OS-SSIs
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Number of participants that have superficial incisional SSIs
timeFrame: 30 days after surgery
measure: Number of participants that have deep incisional SSIs
timeFrame: 30 days after surgery
measure: Number of patients that show highest Clavien-Dindo grade for OS-SSIs
timeFrame: 30 days after surgery
measure: Number of unplanned reoperations
timeFrame: 30 days after surgery
measure: Number of readmissions
timeFrame: 30 days after surgery
measure: Number of participants that have Clostridium difficile infections
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Lillian S Kao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06950047: PediLoc® Blade Plate in Distal Femoral Osteotomies
Official title: Application of PediLoc®Locking Cannulated Blade Plate System in Distal Femoral Osteotomies - A Retrospective, Comparative Analysis of Consolidation Rates and Description of the Surgical Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteotomy of Lower Extremity
Keywords: locking plate system
blade plate
distal femoral osteotomy
flexion contracture
deformities
multidimensional osteotomies
pediatric orthopedics
surgical technique
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 111
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This retrospective study investigated the electronic medical records of patients who underwent distal femoral osteotomy with the Blade Plate system and the 90°LCP-PCP at the University Children's Hospital Zurich between 2020 and 2024.

Brief summary: Background: The PediLoc® Locking Cannulated Blade Plate System, originally designed for proximal femoral osteotomies, has also been used for multidimensional deformity correction of the distal femur. This study describes the surgical technique and retrospectively analyses consolidation rates of distal femoral osteotomies using this system, comparing them to distal femoral osteotomies using the DePuy Synthes® 90°LCP Pediatric Condylar Plate.

Materials and methods: A retrospective review was conducted for patients who underwent distal femoral osteotomy with the PediLoc® Blade Plate (Blade Plate) and the DePuy Synthes® 90°LCP Pediatric Condylar Plate (90°LCP-PCP) at the University Children's Hospital Zurich (2020-2024). Consolidation rates were assessed using Reborn-, Rust-, and modified Rust-scores at 6 weeks, 3 months, and 6 months postoperatively and compared using an unpaired t-test. Geometric planes of osteotomy were analysed, and a stepwise correction technique was described.


Eligibility criteria: Inclusion Criteria:

* All Patients that underwent distal femoral osteotomies
* informed consent

Exclusion Criteria:

* intraoperative technical error
* missing data
* missing IC

Primary outcomes:
measure: Consolidation rates using Reborn-, Rust- and modified Rust-scores on serial X-ray images
timeFrame: 6 weeks, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Children's Hospital Zürich
Study officials:
References:
Clinical trial NCT02905747: The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis
Official title: The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Exercise Therapy
Musculoskeletal Pain
Knee osteoarthritis
Physical Therapy Modalities
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 15
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the project is to investigate effects of medical exercise therapy (MET) on patients with knee osteoarthritis. MET is a common physical therapy intervention, and the project aim to strengthen the evidence of this intervention. An experimental cohort design is chosen, and 20 participants will be followed for 6 months. Assessments will be clinical tests, questionnaires and accelerometer measurements before, during, and after a 3 month period of exercise (3 days per week) with a physical therapist. The project will answer if a 3 month physical therapy intervention using MET causes changes in pain level, function and activity level for patients with knee osteoarthritis. In addition, it will investigate whether a single global endurance workout for 30 minutes will have an effect on pain level for these patients


Eligibility criteria: Inclusion Criteria:

* x-ray verified knee osteoarthritis (Kellegren \& Lawrence grade I-III)
* Loss of function and withstanding pain \>3 months

Exclusion Criteria:

* physical therapy treatment during the last 3 months
* knee injury
* inflammatory arthritis
* symptoms from the hip joints greater than the knee pain
* planned knee surgery the next 6 months
* heart and lung disorders or other health issues affecting the ability to complete the intervention

Primary outcomes:
measure: pain
timeFrame: 6 months
measure: Activity level
timeFrame: 6 months
measure: Function
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Håvard Østerås, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Osteras H, Paulsberg F. The Effect of Medical Exercise Therapy on Pressure Sensitivity in Patients with Knee Osteoarthritis: A Cohort Pilot Study. Pain Ther. 2019 Jun;8(1):79-87. doi: 10.1007/s40122-019-0121-5. Epub 2019 Mar 30.
Clinical trial NCT06870747: Use of TENS in Non-surgical Periodontal Treatment
Official title: Application of Ultra Low Frequency TENS During Non-surgical Periodontal Treatment Relieves Pain and Discomfor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-surgical Periodontal Therapy
Keywords: ULF-TENS
pain
non-surgical periodontal therapy
scaling
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of the study is to verify the use of TENS in non-surgical periodontal therapy in order to relief pain

Detailed description: non-surgical periodontal therapy could be painfull for some patients and the pain that they may experience can let them avoid therapies, with huge risks for their oral health. Transcutaneous electrical neurostimulation (TENS) is a device largely used in temporomandibular disorders in order to reduce pain. The aim of our study is to analyze the effect of Transcutaneous electrical neurostimulation (TENS) at the tragus during non-surgical periodontal therapy fro pain relief

Eligibility criteria: Inclusion Criteria:

* Patients aging more than 18 and of both sexes seeking for non-surgical periodontal treatment

Exclusion Criteria:

* Patients following opioids or analgesic therapies during the study

  * Pregnant women
  * Patients who have had episodes of epilepsy
  * Pace-maker patients
  * Patients who did not signed the informed consent to participate in the study.

Primary outcomes:
measure: Tooth pain during non surgical periodontal therapy
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: University of L'Aquila
state: Aquila
Study officials:
References:
Clinical trial NCT04204447: Hepatitis C-Video vs. Brochure Education Delivery
Official title: A Prospective Study Showing the Effect of Video Interactive Education on Medical Decision Making in Patients on Opiate Replacement Therapy (ORT) With a History of Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the most effective way to give patients information regarding hepatitis C virus infection. The investigators plan to compare the information retained by some patients who are given a brochure alone versus patients who watch an interactive video about hepatitis C.

Detailed description: Subjects will complete 3 questionnaires, including one about knowledge of Hepatitis C. The subject will then either watch a video or read a brochure about Hepatitis C, then take the same questionnaire again. The subject will then return in one month to take the Hepatitis C questionnaire again.

Eligibility criteria: Inclusion Criteria:

* Currently on active treatment for opioid addiction/use
* English as primary language

Exclusion Criteria:

-

Primary outcomes:
measure: Improvement in Scores on HCV Knowledge Questionnaire
timeFrame: Pre-intervention, Immediate post-intervention, and 1 mo. follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Orchard Park
country: United States
facility: BestSelf Behavioral Health
state: New York
Study officials:
affiliation: SUNY University at Buffalo
name: Andrew Talal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Talal AH, Ding YX, Markatou M. Innovations in education: A prospective study of storytelling narratives to enhance hepatitis C virus knowledge among substance users. World J Hepatol. 2022 May 27;14(5):972-983. doi: 10.4254/wjh.v14.i5.972.
Clinical trial NCT02767947: Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis
Official title: A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Product 33525 in Pediatric Subjects With Tinea Corporis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tinea Corporis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-11
Enrollment: 75
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to evaluate the safety, efficacy, and pharmacokinetics of luliconazole cream 1% when applied topically for 7 days in pediatric participants 2 years to 17 years of age (inclusive) with tinea corporis.


Eligibility criteria: Key Inclusion Criteria:

* Participants (or legal guardian/caregiver) with the ability and willingness to sign a written informed consent and/or assent (age appropriate).
* Participants of either gender must be at least 2 years to less than (\<) 18 years of age (2 to 17 years, inclusive).
* Participants with a clinical diagnosis of tinea corporis characterized by clinical evidence of a tinea infection (at least moderate erythema, mild scaling, and moderate pruritus).
* Participants must be in good general health and free of any disease that in the Investigator's opinion might interfere with the study evaluations.
* Participants/caregiver must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements.

Key Exclusion Criteria:

* Participants with active atopic or contact dermatitis in the area to be treated.
* Participants with severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection.
* Female participants who are pregnant and/or nursing or planning a pregnancy during the course of the trial. Participants who test positive for pregnancy after start study drug will be discontinued from study drug but will be followed for safety purposes.
* Participants who are immunocompromised (due to disease, for example; human immunodeficiency virus \[HIV\] or medications).
* Participants who have a recent history of or current drug or alcohol abuse.

Primary outcomes:
measure: Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose)
timeFrame: Pre-dose (within 15 minutes prior to the final dose of the drug) on Day 7
measure: Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose)
timeFrame: 6 hours after the final dose of the drug on Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: San Cristobal
country: Dominican Republic
facility: Valeant Site 03
city: Santo Domingo
country: Dominican Republic
facility: Valeant Site 01
city: San Pedro Sula
country: Honduras
facility: Valeant Site 02
Study officials:
affiliation: Valeant Pharmaceuticals
name: Anya Loncaric
role: STUDY_DIRECTOR
References: