louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04908150: Core Training Protocol vs Traditional Abdomen Exercise Protocol
Official title: A Core Training Protocol Achieves Improvements in Function, Motor Control and Endurance Strength Compared to a Traditional Abdomen Exercise Protocol: a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Performance
Resistance Training
Exercise
Keywords: prevention
core
accelerometer
functional
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 51
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of this study is to analyse the effectiveness of core stability exercises to increase motor control, function and resistance strength of the abdominal muscles, compared to a traditional abdominal and trunk exercise program in semi-professionals soccer players

Detailed description: The 51 participants were semi-professional soccer player and were divided into two different groups using a computer system: the CORE-group or ABDOMINALS-group. Four weeks of training were developed. Outcome variables: Back extension test; Flexion endurance test; FMS; functional movement screen; lateral muscle test right; lateral muscle test left. Kinematic variables were recorded during the test using an accelerometer. A comparison intra-group and intergroup were developed.

Eligibility criteria: Inclusion Criteria:

* semi-professional soccer player

Exclusion Criteria:

* Participants who have suffered a musculoskeletal pathology in the lower limbs and/or having undergone some surgical intervention in the prior year were excluded

Primary outcomes:
measure: Functional Movement Screen
timeFrame: 5 minutes
measure: McGill test
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Manuel Gonzalez-Sanchez
Study officials:
References:
Clinical trial NCT03445650: RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)
Official title: A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of ADX-102 1% Topical Dermal Cream (Reproxalap) in Subjects With Sjögren-Larsson Syndrome (SLS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sjogren-Larsson Syndrome
Keywords: ADX-102, Sjögren-Larsson Syndrome
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-26
Enrollment: 11
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of ADX-102 1% Topical Dermal Cream in Subjects with Sjögren-Larsson Syndrome (SLS).


Eligibility criteria: Inclusion Criteria:

* Subject is aged 3 years or older
* Subject has a genetically-confirmed diagnosis of SLS.
* Subject has active ichthyosis that is Grade 2 or higher on the Visual Index Ichthyosis Severity (VIIS) score.
* Females of child-bearing potential: Negative pregnancy test at Screening and Baseline Visits.

Exclusion Criteria:

* Subject has evidence of a serious active infection.
* Systemic or topical retinoids or other topical medications, not including emollients, within the past 30 days Baseline Visit 1.
* Subject has received an investigational systemic or topically administered drug within the past 30 days prior to Baseline Visit 1.
* Subject is currently receiving immunosuppressive therapy, including intermittent or low-dose systemic corticosteroids.
* Subject has a known allergic reaction to any ingredients of study drug formulation.
* Subject has any clinically significant laboratory test abnormalities or a history of any other condition that, in the opinion of the Investigator, could compromise the subject's ability to comply with the protocol or that could compromise the subject's safety or the interpretation of the study results.

Primary outcomes:
measure: Visual Index Ichthyosis Severity (VIIS) Scaling Score as Assessed by the Investigator in ADX-102 Treated Patients
timeFrame: Efficacy assessment period (Week 1 through Week 24), where Baseline is Day 1.
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
References:
Clinical trial NCT06316050: Retrovertion Assesment and Study in Elderly Patients With Reverse Total Shoulder Arthroplasty
Official title: Retrovertion Assesment and Study of the Subscapularis Function in Elderly Patients With Reverse Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Rotator Cuff Tear Arthropathy
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Determine the optimal degree of retroversion (0-30º) to obtain the best rotational mobility, both internal and external, of the shoulder after implanting a reversed sghoulder arthroplasty (Comprehensive system), and analyze the functional and radiologic results based on humeral retroversion.

Detailed description: Methodology: Open randomized controlled clinical trial. It will be carried out with patients operated with reverse shoulder arthroplasty (at 0º and 30º of humeral retroversion) included consecutively in Terrassa Hospital from January 2019 to June 2021. The estimated sample will be 30 patients per group with diagnosis of massive rotator cuff rupture, rotator cuff arthropaty and primary osteoarthritis with cuff injury, with Walch's type B2 glena or in patients older than 80 years. A global study will be carried out preoperatively and postoperatively with radiographs, computerized tomography, magnetic resonance, and a biomechanical study.

Eligibility criteria: Inclusion Criteria:

* men and women over 60 with the diagnosis rotator cuff massive break (Hamada 2 or more), arthrosis secondary to ruptures of the rotator cuff and primary osteoarthritis with lesion of the cuff, with full Walch B2 type or in patients older than 80 years. Inclusion criteria
* Good functionality of the deltoid muscle.
* Presence of minor round (Hornblower test - no muscle atrophy in nuclear magnetic resonance)
* Accept informed consent

Exclusion Criteria:

* - Review of hemiarthroplasty or anatomical proesis of the affected shoulder.
* Fracture of shoulder in the upper extremity to intervene.
* Central neurological diseases
* Advanced cognitive impairment
* Brachial plexus injuries
* Local or systemic infection.
* Oncological disease
* Treatment with immunosuppressants.

Primary outcomes:
measure: INTERNAL ROTATION
timeFrame: 2 YEARS
measure: INTERNAL ROTATION
timeFrame: 2 YEARS
Secondary outcomes:
measure: EXTERNAL ROTATION
timeFrame: 2 YEARS
measure: FORWARD ELEVATION
timeFrame: 2 YEARS
measure: Simple shoulder test
timeFrame: 2 years
measure: Constant test
timeFrame: 2 years
measure: ASES test
timeFrame: 2 years
measure: Glenoid inclination angle
timeFrame: 2 years
measure: glenoid retroversion angle
timeFrame: 2 years
measure: abduction
timeFrame: 2 years
measure: center of rotation
timeFrame: 2 years
measure: lateralizaiton offset
timeFrame: 2 years
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: JM MORA
state: Barcelona
Study officials:
References:
Clinical trial NCT06308250: Comparative Effects of Mime Therapy and Action Observation Therapy in Bell's Palsy
Official title: Comparative Effects of Mime Therapy and Action Observation Therapy on Facial Symmetry and Quality of Life in Bell's Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bell Palsy
Keywords: Bell Palsy
Breathing exercise
Comparative
MIME Protocol
Randomized clinical trial
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine comparative effects of mime therapy and action observation therapy on facial symmetry and quality of life in Bell's palsy. Bell's palsy is characterized as an abrupt paralysis of the peripheral facial nerve, typically without a known cause. Mime Therapy is a performing technique that helps patients regain the ability to use their face muscles. Action observation therapy is novel rehabilitation approach exploiting this mirror mechanism.

Detailed description: This randomized clinical trial will be conducted at Sir Ganga Ram Hospital in 7 months. 62 participants with Bell's palsy will be included as per sample size calculation through convenience sampling technique. Participants which meet inclusion criteria will be randomly allocated using online randomization tool into two groups. Group A will receive Mime therapy for 30 minutes with short resting interval and Group B will receive action observation therapy for 30 minutes. Each group will receive treatment session of 5 days per week for 6 weeks.

Facial symmetry will be measured using the 13-item Sunny Brook facial Grading System, Facial disability index will be used to assess the quality of life and The House-Brackmann Facial Nerve Grading System will be used to characterize the degree of facial paralysis. The data will be analyzed using SPSS version 24 for Windows software.

Eligibility criteria: Inclusion Criteria:

1. Bell's Palsy with acute onset of 1-3 weeks.
2. Unilateral loss of facial weakness.
3. Patients with intact taste sensation.
4. Bell's Palsy of House Brackmann grade 3 and 4.
5. Idiopathic Bell's Palsy.

Exclusion Criteria:

1. History of facial palsy recurrence.
2. Stroke associated Bells palsy.
3. History of pregnancy
4. Subjects with any disability, fracture, or tumor.
5. History of facial surgery.
6. Subject having skin allergy on face.

Primary outcomes:
measure: Sunny Brook Facial Grading System
timeFrame: 6th week
measure: Facial Disability Index
timeFrame: 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhmmad Kashif, PhD-PT
role: STUDY_CHAIR
References:
Clinical trial NCT03764150: Factors Associated With Hypoventilation in the Myotonic Dystrophy, Progressive Profile Over 5 Years
Official title: Factors Associated With Hypoventilation in the Myotonic Dystrophy, Progressive Profile Over 5 Years
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myotonic Dystrophy, Steinert
Keywords: Sleep Apnea Syndrome
Muscular Diseases
non invasive ventilation
Diaphragmatic Disorder
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with a myotonic dystrophy of Steinert who consults in pneumology and who will have Respiratory functional exploration

Brief summary: The aim of this study is to determine the factors associated with alveolar hypoventilation in terms of cognitive impairment, daytime sleepiness, respiratory function, nocturnal respiratory events This evaluation will clarify the clinical phenotypes of respiratory disease in myotonic steinert dystrophy.


Eligibility criteria: Inclusion Criteria:

* Myotonic dystrophy of Steinert genetically confirmed (number of known CTG repeats), in its classical form of adult

Exclusion Criteria:

* Inability to perform EFR assessment or polysomnography
* Moderate to severe asthma according to the GINA classification
* moderate to severe COPD (\> stage 1 of the GOLD recommendations)
* Other significant respiratory pathology
* Patient already on NIV, CPAP or under oxygen therapy
* Impossibility of receiving enlightened information
* Inability to participate in the entire study

Primary outcomes:
measure: Change of measurement of spirometry
timeFrame: every year during 5 years
measure: Change respiratory force
timeFrame: every year during 5 years
measure: Change CO2 response (Read test)
timeFrame: every year during 5 years
measure: Change subjective sleepiness (Epworth)
timeFrame: every year during 5 years
measure: change Krupp's Fatigue Severity Scale (KFSS)
timeFrame: every year during 5 years
measure: change cognitive impairment by Trail Making Test A & B
timeFrame: every year during 5 years
measure: change Oximetry
timeFrame: every year during 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Hospitalier Regional D' Angers
city: Garches
country: France
facility: Ap-Hp Hu Paris Site Raymond Poincare
city: Lille
country: France
facility: Hôpital Calmette, CHRU
city: Montpellier
country: France
facility: Chu Montpellier
city: Nantes
country: France
facility: Chu de Nantes :Site Hôtel-Dieu- Hme - Nantes 1
city: Paris
country: France
facility: Ap-Hp Hu Pitie Salpetriere
Study officials:
affiliation: University Hospital, Lille
name: Thierry Perez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06724250: Biofeedback Therapy Versus Botox Injection in Treatment of Dyssynergic Defecation.
Official title: Biofeedback Versus Botox Injection in Treatment of Dyssynergic Defecation (Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructed Defaecation Syndrome
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 78
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: assessment the Improvement symptoms of obstructed defecation after biofeedback training versus botulinum toxin injection

Detailed description: This is a randomized controlled trial including 78 patients diagnosed with obstructed defecation syndrome confirmed by detailed history talking, full clinical examination, anorectal manometry and defecography.

Included patients divided into two equal groups: first group ( biofeedback therapy group) patients recieved biofeedback therapy for six sessions over one month, the second group:( botulinum toxin group) received botulinum toxin injection 100 IU in buborectalis muscle.

The primary outcome is improvement of symptoms after one year

Eligibility criteria: Inclusion Criteria:

* patients of both genders
* age of 18 years or older
* fulfillment of the Rome 3 constipation criteria for the past 3 months, symptom onset as a maximum six months prior to diagnosis, patients suffer from prolonged, incomplete and challenging evacuation

Exclusion Criteria:

* Anismus cases with secondary reason for constipation
* patients who undergone anorectal surgery Patients with colonic inertia
* conditions that make biofeedback training impossible
* cases with primary illness causing constipation as hypothyroidism

Primary outcomes:
measure: Improvement of symptoms of constipation for one year follow up
timeFrame: One year
Secondary outcomes:
measure: Improvement of pain for one year follow up
timeFrame: One year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura faculty of medicine
Study officials:
References:
Clinical trial NCT02938650: Nitrosomonas Eutropha on Nitrolipids in the Skin
Official title: Assessing the Role of Nitrosomonas Eutropha on Nitrolipids in the Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation
Keywords: nitrolipid
microbiome
inflammation
cytokine
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 15 healthy controls will participate in the study Another set of healthy controls (n=20) will be recruited so that they participate in blood draws.
Primary purpose: TREATMENT

Brief summary: We are looking to see how the addition of nitrosomonas alters the presence of nitrolipids and inflammatory cytokines on the skin.

Detailed description: We are looking to see how the nitrosomonas alters nitrolipids in the skin and the inflammatory cytokines of the skin.

We will be using healthy subjects over the course of 2 weeks.

Subjects will be using a neutral cleanser for one week prior to the study, skin microbiome,facial photography, lipid and cytokine measurements will be taken at baseline. Subjects will then start using nitrosomonas spray twice daily for one week.

There is a portion of the study where the subjects will have skin microbiome, facial photography, lipid measurements, blood pressure measurements and a bloow draw before and after using the nitrosomonas spray for one week.

Eligibility criteria: Inclusion Criteria:

* Those aged 18 and over
* Healthy Subjects with clear skin

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Those with acne, eczema, seborrheic dermatitis, rosacea or polycystic ovarian syndrome
* Those who have started new oral medication in the last four weeks
* Those who have used systemic antibiotics in the last month
* Those who have used isotretinoin in the last 6 weeks
* Those who have used topical antibiotics or retinoid in the last two weeks.
* Those who have autoimmune or metabolic diseases
* Those who have changed brands of oral contraceptive within the last four weeks
* Those who have chronic medical disorders
* Those whose with active skin infections
* Concomitant use of nitrates
* Concomitant use of anti-hypertensive agents
* Those with syncopal episodes

Primary outcomes:
measure: Alteration in microbiome diversity and species
timeFrame: one week
measure: Alteration in nitrolipids in the skin
timeFrame: one week
Secondary outcomes:
measure: Alteration in skin cytokines
timeFrame: one week
measure: Alteration in blood lipids
timeFrame: one week
measure: Blood pressure readings
timeFrame: one week
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Dermatology Clinical Trials Unit
state: California
Study officials:
affiliation: UC Davis
name: Raja K Sivamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05363150: Feasibility of a Smart Device Application for Home-based Prehabilitation
Official title: Feasibility of a Smart Device Application for Home-based Prehabilitation in Patients Undergoing Lung Cancer Surgery: A Prospective Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Prehabilitation
Keywords: Cancer patient
Cancer Surgery
Prehabilitation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who visits preoperative evaluation clinic for preoperative counseling before the cancer surgery

Brief summary: To investigate the feasibility of a home-based exercise training program using a smartphone application in patients planning for cancer surgery, and to determine the effectiveness of this application on functional capacity.


Eligibility criteria: Inclusion Criteria:

* Adult patients (19-70) who are scheduled for elective cancer surgery
* American Society of Anesthesiologists (ASA) physical status classification I or II
* Patients who can use a smartphone application
* Patients who can perform an exercise program for at least 3 weeks from the first visit to the preoperative clinic to elective surgery

Exclusion Criteria:

* Patients who are unable to communicate
* Patients under the age of 19 and over 70
* Patients who have a major medical or psychiatric disorder that is expected to affect exercise
* Patients with contraindications to the general rehabilitation program

Primary outcomes:
measure: Compliance of a smartphone application
timeFrame: A day before surgery at ward
measure: Satisfaction of a smartphone application
timeFrame: A day before surgery at ward
Secondary outcomes:
measure: Korean-EORTC QLQ C-30
timeFrame: 4 weeks before the surgery at clinic, a day before the surgery at ward
measure: 6-minute walk test
timeFrame: 4 weeks before the surgery at clinic, a day before the surgery at ward
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Susie Yoon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05464550: Role of Self-focused Attention in Depression
Official title: Role of Self-focused Attention in Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Using a task measuring the tracking of eye movements, the aim of this study is to demonstrate that individuals suffering from depression focus their attention more on their reflection in the screen after recalling a failure (and this all the more so as their depressive symptomatology is strong) .


Eligibility criteria: Inclusion Criteria:

* patients with depressive disorders according to the Diagnostic and statistical Manual of Mental Disorders (DSM-V) criteria
* Men or women, aged 18 to 60
* patients without mental impairment
* patients without neurological impairment (epilepsy, encephalopathy, head trauma)
* patients with a sufficient command of French
* free patients, without guardianship or curators or subordination
* patients benefiting from coverage by a social security scheme or benefiting from it through a third party in accordance with the French law on biomedical research
* obtaining oral non-objection by the patient after clear and honest information about the study
* Patient with normal or corrected vision without rigid contact lenses

Exclusion Criteria:

* patients with an intelligence quotient \< 70
* patients aged \< 18 years or \> 60 years
* patients with mental impairment
* patients with neurological impairment (epilepsy, encephalopathy, head trauma)
* patients who do not speak French well enough
* patients hospitalized under duress
* patients without social security
* Patient wearing rigid contact lenses

Primary outcomes:
measure: Percentage of time
timeFrame: through study completion, an average of 10 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
Study officials:
References: