louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04870151: Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture
Official title: Anterolateral Versus Direct Lateral Approach in Hemiarthroplasty for Hip Fracture: A Randomised Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Fractures
Keywords: Surgical approach
Hemiarthroplasty
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: Patients with dislocated hip fractures are randomised to cemented hemiarthroplasty with an anterolateral approach or a direct lateral approach.

Detailed description: Dislocated intracapsular hip fractures are usually treated with cemented hemiarthroplasty. In Norway, a direct lateral approach is most often used, as recommended in national guidelines. In total hip arthroplasty, however, minimally invasive approaches are also commonly used, and may improve the clinical results, as compared to posterior or direct lateral approaches.

The aims of the present study are to evaluate the effect of the minimally invasive anterolateral approach (Watson-Jones approach) compared to the direct lateral approach (Hardinge approach) to the hip joint in hemiarthroplasty after dislocated hip fractures.

Patients with dislocated hip fractures who are fit for cemented hemiarthroplasty are randomised to surgery with an anterolateral approach or a direct lateral approach.

Eligibility criteria: Inclusion Criteria:

* dislocated hip fracture.
* planned cemented hemiarthroplasty.
* able to walk, with or without walking aids, prior to the injury.

Exclusion Criteria:

* young and healthy patients with displaced hip fractures who are recommended total hip arthroplasty or open reduction / internal fixation of the fracture.
* patients with severe comorbidity and high risk of cement-related complications who are recommended uncemented hemiarthroplasty (some, but not all, patients with ASA (American Society of Anesthesiologists) grade 4).
* not able to give informed consent.

Primary outcomes:
measure: Harris Hip Score (HHS)
timeFrame: 12 months
Secondary outcomes:
measure: EuroQol questionnaire (EQ-5D)
timeFrame: 12 months
measure: Patient-reported limping
timeFrame: 12 months
measure: Patient-reported use of walking aid
timeFrame: 12 months
measure: Trendelenburg test
timeFrame: 12 months
measure: Timed Up and Go (TUG)
timeFrame: 12 months
measure: Blood loss
timeFrame: During surgery
measure: Duration of surgery
timeFrame: During surgery
measure: Length of hospital stay
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Cause of death
timeFrame: 12 months
Other outcomes:
Locations:
city: Gjøvik
country: Norway
facility: Innlandet Hospital Trust
state: Innlandet
Study officials:
affiliation: Sykehuset Innlandet HF
name: Håvard Furunes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06856551: Using Tailored Messages to Encourage Healthy Lifestyle Choices in a Brief, Self-directed Intervention
Official title: Using Tailored Messages to Encourage Healthy Lifestyle Choices in a Brief, Self-directed Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Control
Lead sponsor: University of North Florida
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 200
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 study aimed to investigate 1) if a brief, regulatory focus-based intervention could promote weight control and changes in certain lifestyle behaviors and 2) how weight was affected by changes in these behaviors. The lifestyle behaviors of interest included meal regularity, self-monitoring of diet and physical activity, fast-food eating, screen related viewing and eating, dietary modifications, self-weighing, and physical activity. It was hypothesized that increases in meal regularity, self-monitoring, healthy dietary modifications, self-weighing, and physical activity would lead to better weight control over six months. Conversely, it was hypothesized that increases in fast food consumption and screen related eating and viewing would lead to poorer weight control over six months. It was expected that promotion and prevention conditions, relative to the control condition, would lead to better weight control and increases in meal regularity, self-monitoring, healthy dietary modifications, self-weighing, and physical activity, and decreases in fast food consumption and screen related eating and viewing. Furthermore, it was expected that the promotion condition would lead to better outcomes than the prevention condition.


Eligibility criteria: Inclusion Criteria:

* 18+ years old
* generally healthy
* BMI between 18.5 and 35

Exclusion Criteria:

* pregnancy within the past 6 months
* current pregnancy
* plan to get pregnant in the next 6 months
* serious physical or psychological problems that would contraindicate participation in a weight-related program
* history of anorexia or bulimia
* diabetes or hypertension
* current participation in a weight-loss program
* BMI \< 18.5, \>35.0

Primary outcomes:
measure: Weight Change
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: meal regularity change
timeFrame: baseline, 3 months
measure: fast-food eating change
timeFrame: baseline, 3 months
measure: screen related eating and viewing change
timeFrame: baseline, 3 months
measure: dietary modifications change
timeFrame: baseline, 3 months
measure: self-monitoring change
timeFrame: baseline, 3 months
measure: self-weighing change
timeFrame: baseline, 3 months
measure: physical activity change
timeFrame: baseline, 3 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of North Florida
state: Florida
Study officials:
References:
Clinical trial NCT05906251: A Gene Transfer Study to Evaluate the Safety, Tolerability and Efficacy of SRP-6004 in Ambulatory Participants With Limb Girdle Muscular Dystrophy, Type 2B/R2 (LGMD2B/R2, Dysferlin [DYSF] Related)
Official title: An Open-Label, Systemic Gene Transfer Study to Evaluate the Safety, Tolerability, and Efficacy of SRP 6004 Administered by Systemic Infusion in Ambulatory Subjects With Limb Girdle Muscular Dystrophy Type 2B/R2 (LGMD2B/R2, Dysferlin Related)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Limb Girdle Muscular Dystrophy
Keywords: Ambulatory
Gene-Delivery
LGMD2B/R2
Dysferlin
LGMD
Lead sponsor: Sarepta Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the safety of SRP-6004 administered by intravenous (IV) infusion in ambulatory participants with LGMD2B/R2 (DYSF related).


Eligibility criteria: Inclusion Criteria:

* Possess 1 homozygous or 2 heterozygous pathogenic and/or likely pathogenic DYSF Deoxyribonucleic acid (DNA) gene mutations as documented prior to screening visits.
* Participants must be ambulatory per protocol specified criteria.
* Ability to cooperate with motor assessment testing.
* Has accessible and intact lower and upper extremity musculature for biopsy.
* Have adeno-associated virus rhesus serotype 74 (rAAVrh74) antibody titers \< 1:400 (that is, not elevated) as determined by enzyme-linked immunosorbent assay (ELISA).

Exclusion Criteria:

* Exposure to gene therapy, investigational medication, or other protocol-specified treatment within the protocol specified time limits.
* Abnormality in protocol-specified diagnostic evaluations or laboratory tests.
* Presence of any other clinically significant illness, medical condition, or requirement for chronic drug treatment that in the opinion of the Investigator creates unnecessary risk for gene transfer.

Note: Other inclusion or exclusion criteria could apply.

Primary outcomes:
measure: Number of Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)
timeFrame: Baseline up to Month 60
Secondary outcomes:
measure: Change from Baseline in Percent of Normal DYSF Protein Expression as Measured by Western Blot
timeFrame: Baseline, Day 90 and Month 15
measure: Change from Baseline in Percent of Normal DYSF Protein Expression as Measured by Immunofluorescence (IF) Fiber Intensity
timeFrame: Baseline, Day 90 and Month 15
measure: Change from Baseline in Percent of Normal DYSF Protein Expression as Assessed by IF Percent DYSF Positive Fibers (PPF: DYSF)
timeFrame: Baseline, Day 90 and Month 15
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Sarepta Therapeutics, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00711451: Manual and Expressed Placental Removal at Cesarean Delivery and Its Effects on Various Cardiac Indices
Official title: Manual and Expressed Placental Removal at Planned Cesarean Delivery and Its Effects on Various Cardiac Indices as Measured By Continuous Wave Doppler Ultrasonography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy
Cesarean Delivery
Keywords: systemic vascular resistance
pregnancy
scheduled cesarean delivery
syncytiotrophoblast apoptosis
continuous wave Doppler
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2008-07-08
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether manual removal of the placenta during a cesarean delivery results in higher changes in the resistance of blood flow throughout the body, also called systemic vascular resistance (SVR)

Detailed description: Patients presenting to William Beaumont Hospital Royal Oak Labor and Delivery for a scheduled low transverse cesarean delivery will be asked to participate in a prospective, randomized study to evaluate any changes in systemic vascular resistance (SVR) pre- and post-delivery.

After obtaining informed consent, the patients will be randomized to one of two groups: group 1 will have manual removal of the placenta at cesarean section and group 2 will have expressed removal of the placenta at cesarean section.

Both groups will have a pre-operative continuous wave Doppler evaluation and a post-operative continuous wave Doppler evaluation at 24 hours after delivery. Continuous wave Doppler evaluation will be used pre- and post-operatively to evaluate any changes in SVR.

Eligibility criteria: Inclusion Criteria:

* pregnant
* scheduled for cesarean delivery
* able to give informed consent

Exclusion Criteria:

* taking medications that may affect hemodynamics
* unable to give informed consent

Primary outcomes:
measure: Hemodynamic profile, especially Systemic Vascular Resistance
timeFrame: immediately before and 24 hours after cesarean delivery
Secondary outcomes:
measure: development of postpartum preeclampsia
timeFrame: within 1 week of delivery
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Christian Bogner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02402751: Development, Implementation and Initiation of Normative Database Quantitative Ultra High Field MRI Paramaters
Official title: Development, Implementation and Initiation of Normative Database Quantitative Ultra High Field MRI Paramaters
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Volunteers
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The Centre for Magnetic Resonance in Biology and Medicine (CRMBM, UMR-CNRS 7339 AMU) obtained funding for a whole body NMR imaging at 7. It is the only MRI at 7T installed in a hospital in France (only two 7T MRI in France) and therefore a unique opportunity to develop new diagnostic approaches.

The purpose of this study is to develop, implement and validate new MRI quantitative parameters derived from ultra high field MRI in order to characterize non-invasively with an unprecedented resolution and sensitivity, anatomy as well as certain physiological, hemodynamic and metabolic function of brain, spinal cord, musculoskeletal system, and heart in healthy subjects

Detailed description: The key is that the goal of our projects is not only producing images of better quality than using a 3T scanner but also making images differently, by highlighting new contrasts and features of theses organs in order to improve the diagnosis and prognosis of neurological, psychiatric, cardiovascular and rheumatologic diseases.

Eligibility criteria: Inclusion Criteria:

* People not presenting contraindications to the MRI (pacemaker, agitation, metallic brightness, claustrophobia etc.)
* People having no intra-physical object potentially conductive.
* People having no affection after detailed interrogation

Exclusion Criteria:

* People staying in a sanitary or social establishment
* People in emergency situation
* People not wishing to be informed about anomalies in the MRI
* Pregnancy

Primary outcomes:
measure: qualitative validation concerning structure visible with high field MRI
timeFrame: 4 years
Secondary outcomes:
measure: acquisition of normative data and verification of the quality criteria obtained during the first phase
timeFrame: 4 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique - Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Maxime GUYE, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04386551: Detection of COVID-19 in Saliva Collection
Official title: Evaluation of the Performance of a Saliva Sample Versus a Nasopharyngeal Sample in the Diagnosis of COVID-19 by RT-PCR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
RT-PCR
Saliva Collection
Nasopharyngeal Sample
Keywords: Sars-CoV2
RT-PCR
Saliva collection
nasopharyngeal sample
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult ambulatory patients screened for SARS Cov 19 at the CHU Amiens COViD clinic will be included in the study. A double sample will be taken from the saliva and the nasopharynx in parallel using the same sample kit. This double sampling has no direct impact on conventional patient management.

Brief summary: Since December 2019, the world has faced a pandemic of COVID-19, an infectious disease caused by SARS-CoV-2, a virus that emerged in China. The reference diagnosis is based on the search for the SARS-COV-2 genome in the nasopharyngeal sample.

Carrying out this sample requires the competence of a healthcare professional and presents some inconveniences for the tested patient. Because saliva collection is simple, non-invasive, painless and inexpensive, and can be performed by poorly trained personnel, it could be an alternative to the reference nasopharyngeal sample. SARS-CoV2 detection in human saliva could be a potential diagnosis of COVID infection.


Eligibility criteria: Inclusion Criteria:

* patient hospitalized at the Amiens CHU in a COVID-19 unit
* patient seen as outpatient in the area of infectious pathologies for COVID-19 infection

Exclusion Criteria:

* Patients under 18
* patients under guardianship or curators

Primary outcomes:
measure: Detection of SARS-CoV-2 RNA in the saliva sample
timeFrame: day 1
measure: Concordance between the Saliva sample and the nasonasopharyngeal sample SARS-CoV-2 RT-PCR results
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT03494751: Heart Monitoring Device After Acute Myocardium Infarction
Official title: Heart Monitoring Device After Acute Myocardium Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Monitoring
Myocardial infarction
Clinical trial
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 358
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: Verify the effectiveness of a Heart Monitor in preventing events in patients over 18 years after acute myocardial infarction in a clinical unit. Patients with neurological disease or congenital heart disease we excluded from the study.

Detailed description: Heart Monitor can detect early intercurrences. Objective: To verify the effectiveness of a Heart Monitoring system in preventing events in patients after acute myocardial infarction. Methodology: This is a randomized clinical trial to be developed in a clinical unit and will include patients over 18 years , post-acute myocardial infarction who were transferred from the ICU emergency or hemodynamic to clinical unit. Patients with neurological disease or congenital heart disease will be excluded from the study.

Eligibility criteria: Inclusion Criteria:

* patients over 18 years
* patients post-acute myocardial infarctium

Exclusion Criteria:

* patients with neurological disease
* patients with congenital heart disease

Primary outcomes:
measure: Heart rhythm monitoring
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Instituto de Cardiologia do Rio Grande do Sul
name: silvia goldmeier
role: STUDY_CHAIR
References:
Clinical trial NCT06671951: Focal Vibration for Enhancing Athletic Speed and Ppower
Official title: Effectiveness of Focal Vibration in Enhancing Lower Extremity Speed and Power in Athletes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: To Assess the Effectiveness of a Focal Vibration Treatment on Squat Power and Speed in Athletes Who Perform Squats
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A focal vibration device will be used to perform an activation and warm-up protocol before performing a set of 7 repetitions of squat with 60% of your 1RM.


Eligibility criteria: Inclusion Criteria:

* Study participants must have signed the informed consent form to assess their inclusion in the study.
* Familiarity with the technique and practice of the weighted free squat.
* Training at least 3 times per week.

Exclusion Criteria:

* Volunteers who have suffered a sports injury during the last two months or are unable to perform physical activity.
* Have previously received an intervention with focal vibration.
* Not understanding the information provided by the therapist.
* Participate in other research studies.
* Be undergoing pharmacological medical treatment that may interfere with the measurements, such as treatment with anticonvulsants, antidepressants, etc.

Primary outcomes:
measure: Mean Speed during squat
timeFrame: 1 minute
measure: Mean Power during squat
timeFrame: 1 minute
Secondary outcomes:
measure: Scale of perceived effort during squat
timeFrame: 1 minute
measure: Participant's rating of clinical change. Global Rating of Change Scale (GROC scale).
timeFrame: 1 minute
measure: Muscle Activity
timeFrame: 1 minute
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06990451: Time Pressure Motor Training With Step Square Exercise on Stroke Patients
Official title: Effect of Time Pressure Motor Training With Step Square Exercise on Decision Making Ability and Quality of Life in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to investigate The Efficacy of Time Pressure motor rehabilitation with step square exercise (SEE) on decision making ability \& quality of life in stroke Patients

Detailed description: PURPOSE: to investigate The Efficacy of Time Pressure motor rehabilitation with step square exercise (SEE) on decision making ability \& quality of life in stroke Patients BACKGROUND: stroke patients demonstrate impairments in decision making ability leads to deficits in patient's quality of life.

Eligibility criteria: Inclusion Criteria:

* age from 50 to 65 years old
* both Sex
* the duration of illness more than three months
* post stroke hemiplegia
* mild spasticity ranged from (1:1+) according to Modified Ashworth Scale

Exclusion Criteria:

* stroke occurred less than 3 months ago
* Patients with severe cognitive or psychiatric impairment aphasia who could not understand the instructions given to him by physical therapist or unable to perform the task
* any other orthopedic disorders or neurologic diseases.

Primary outcomes:
measure: The Trail Making Test
timeFrame: four weeks
measure: Mini-Mental State Exam
timeFrame: four weeks
Secondary outcomes:
measure: Stroke Specific Quality of Life
timeFrame: four weeks
measure: The Functional Independence Measure
timeFrame: four weeks
Other outcomes:
Locations:
city: Al Jīzah
country: Egypt
facility: Lama Saad El-Din Mahmoud
state: Select State
Study officials:
References: