louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03406143: Evaluation of the Effect of CGF in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration
Official title: Evaluation of the Effect of CGF in Promoting Mechanical-stretch Induced in Vivo Skin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scar
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 26
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluating whether autologous Concentrate Growth Factors(CGF) is safe and/or effective to accelerating skin regeneration and soft tissue expansion.


Eligibility criteria: Inclusion Criteria:

* Age of 14 to 65 years;
* Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
* Persistent high level of expander internal pressure;
* Need for further skin expansion;

Exclusion Criteria:

* • Not fit for soft tissue expansion treatment;

  * Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
  * Significant renal, cardiovascular, hepatic and psychiatric diseases;
  * Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV)
  * BMI \>30;
  * History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
  * History of allogenic bone marrow transplantation;
  * Long history of smoking;
  * Evidence of malignant diseases or unwillingness to participate.

Primary outcomes:
measure: To Measure the Change in Inflation Volume of the Silicone Expander From Baseline at 8 Weeks
timeFrame: baseline and 8 weeks post treatment
Secondary outcomes:
measure: To Measure the Texture of Expanded Flap With Canfield's Visia Scanner
timeFrame: baseline and 8 weeks post treatment
measure: Occurence of Major Adverse Events
timeFrame: Up to approximately 24 months after study start
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
Study officials:
References:
Clinical trial NCT06345443: NRM on Vascular Perfusion in Healthy Adults
Official title: The Effect of Oral Nicotinamide Riboside on Systemic Vascular Perfusion in Healthy Adults: A Critical Foundation of Cerebrovascular Health, Cardiovascular Health, and Healthy Aging
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Vascular Stiffness
Keywords: cardiovascular
Nicotinamide Riboside
Supplements
NRM
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to better understand the effects of nicotinamide riboside supplement in overall cardiovascular health in healthy adults.

Detailed description: This study is a randomized, double-blind, placebo-controlled, parallel-dose clinical trial. Participants will be randomly assigned to one of three groups. Study measurements will be completed at three timepoints and intervention taken daily throughout the subject's 12 weeks of participation.

Eligibility criteria: Inclusion Criteria:

* \>= 40 and \<=60
* Provides consent to participate in the study
* Not pregnant at time of consent
* Understands and agrees to follow all study procedures and limitations
* Have no contraindicating comorbid health condition as determined by the clinical investigators

Exclusion Criteria:

* Pregnant, nursing, or trying to conceive
* BMI Restrictions: \<30
* Allergy or sensitivity to study agent ingredients
* Hypertension treated with medication
* Use of natural health products containing nicotinamide riboside, quercetin, trans-resveratrol, or betaine anhydrous within 7 days prior to randomization and during the course of the study.
* Surgery planned during the course of the trial
* History or past diagnosis of chronic diseases, unstable medical conditions, blood/bleeding disorders or stroke
* History or current diagnosis of cancer (except for successfully treated basal cell carcinoma diagnosed less than 5 years prior to screening or cancer in full remission more than 5 years after diagnosis.
* Abnormal blood chemistries for renal or liver function (defined as 1 standard deviation outside of the normal range), alcohol dependence, uncontrolled thyroid disease, severe obesity (body mass index \>40 kg m-2), or weight stable for at least 3 months prior to enrolling in the study (defined as \>2 kg change in body mass).
* An unstable medical or mental health condition as determined by the physician investigator.

Primary outcomes:
measure: Number of Participants with Reduced Endothelial Stiffness
timeFrame: Baseline to End of study at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ryan Hurt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Brent Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01210443: Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
Official title: A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypertension, Pulmonary
Keywords: sitaxentan sodium pulmonary hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-28
Enrollment: 2
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU, Canada and Australia. In this study, the long-term safety and efficacy after administrations of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will be investigated in Japanese PAH patients.


Eligibility criteria: Inclusion Criteria:

* Subject who completed the B1321052 study as planned.

Exclusion Criteria:

* Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \>160 mm Hg or sitting diastolic blood pressure \>100 mm Hg at Screening.
* Has hypotension defined as systolic arterial pressure \<90 mm Hg after sitting for 5 minutes at Screening.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to 22 days (last participant discontinuation)
Secondary outcomes:
measure: Percentage of Participants With Clinical Worsening
timeFrame: Up to 22 days (last participant discontinuation)
measure: Change From Baseline in 6-Minute Walk Distance
timeFrame: Up to 22 days (last participant discontinuation)
measure: Percentage of Participants With Change From Baseline in WHO Functional Class
timeFrame: Up to 22 days (last participant discontinuation)
measure: Change From Baseline in Blood Concentration of N-amino Terminal Fragment of the Prohormone Brain Natriuretic Peptide (NT-pro BNP)
timeFrame: Up to 22 days (last participant discontinuation)
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Shinjyuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04217343: NCAMR-CAMR Allosure Study
Official title: NON-COMPLEMENT MEDIATED AMR vs. COMPLEMENT MEDIATED AMR: DOES DD-cfDNA/GEP SHOW A DIFFERENCE
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transplant Failure
Keywords: Heart
Lead sponsor: Tampa General Hospital
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone Orthotopic Heart Transplantation who have pAMR1 rejection will be included in the study.

Brief summary: Heart Transplant recipients at Tampa General Hospital heart transplant program who have pAMR1(H+) or pAMR1(I+) rejection will have a DD-cfDNA /GEP sample obtained at the time of the rejection. The DD-cfDNA/GEP will then be drawn every month post treatment for the rejection until the DD-cfDNA/GEP level returns to normal. A total of fifteen recipients with pAMR1(H+) and fifteen recipients with pAMR1(I+) rejection will be included in the study which will last two years. The presence of HLA antibodies (DSA's) and the titers, presence of Autoantibodies, the measurement of cytokines IL2, IL4, IL6, IL 10, IL 17, TNF alpha, TGF beta, the presence of coronary artery vasculopathy, the time from transplant to the onset of the episode of AMR, time to resolution, the response to treatment and comparison to the DD-cfDNA/GEP level with pAMR2 and pAMR 3 rejections will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Patients who have undergone Orthotopic Heart Transplantation who have pAMR1 rejection.

Exclusion Criteria:

* Subjects less than 18 years old

Primary outcomes:
measure: The level of dd-cfDNA in non-compliment mediated pAMR1 (H+) and complement mediated pAMR1 (I+) heart transplant rejection will be measured.
timeFrame: 2 years
Secondary outcomes:
measure: The level of inflammatory cytokines in non-compliment mediated pAMR1(H+) and compliment mediated pAMR1(I+) heart transplant rejection will be measured.
timeFrame: 2 years
measure: The presence of HLA antibodies (DSA's) and titer levels, autoantibodies and titer levels and coronary artery vasculopathy will be measured.
timeFrame: 2 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: Tampa General Hospital/Tampa General Medical Group
name: Benjamin Mackie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04690543: Comparison of Length Gain Between Square Flap and Z-plasty in Post Burn Contracture Release
Official title: Comparison of Length Gain Between Square Flap and Z-plasty in Post Burn Contracture Release
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burn Scar
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study
Primary purpose: TREATMENT

Brief summary: the purpose of this study is to compare the gain in length after postburn contracture release using two different techniques, the more commonly practised z - plasty and relatively newer technique, square flap


Eligibility criteria: Inclusion Criteria:- • Both genders.

* Joints supple.
* Linear contracture bands.
* Age between 5years to 50 years.
* Surrounding non scarred skin.
* Contractures of axilla, cubital fossa, popliteal fossa and digits.

Exclusion Criteria:

* Deep burns.

  * Joint contractures.
  * Surrounding skin scarred.
  * Broad, irregular contracture.
  * Neck, Perineal, wrist or toe contractures

Primary outcomes:
measure: gain in length
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: DUHS
name: Aiman Naseem
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05917743: Mat Pilates Versus General Exercises for Patients With Nonspecific Acute Low Back Pain
Official title: Mat Pilates vs. General Exercises for Acute Nonspecific Low Back Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: To compare the effectiveness of Mat Pilates with General Exercises in treating patients with nonspecific acute low back pain.

Novelty: Pilates, typically performed with specific equipment, has shown clinically significant treatment effects in people with chronic low back pain. Recent guidelines recommend patients remain active during episodes of low back pain; however, evidence regarding the type of exercise to perform is limited. Mat Pilates is a type of Pilates exercise that does not require complex equipment. Evaluating the effectiveness of two simple exercise methods (Mat Pilates and General Exercises) can help expand intervention options for patients with acute low back pain, enabling them to choose an exercise they enjoy most.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 50 years old
* Acute nonspecific low back pain with at least 3 points on the Visual Analog Scale (VAS)
* Willing and able to provide informed consent
* Able to comply with the study protocol and attend all treatment sessions and follow-up assessments

Exclusion Criteria:

* Presence of specific low back pain causes, such as lumbar radiculopathy, spinal stenosis, or spondylolisthesis
* Previous spinal surgery
* Contraindications to exercise, such as severe cardiovascular or respiratory conditions
* Currently pregnant or planning to become pregnant during the study period
* Participation in another clinical trial or receiving concurrent experimental treatment for low back pain

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: Change from baseline to 4 weeks and 3 months
Secondary outcomes:
measure: Change in Disability
timeFrame: Change from baseline to 4 weeks and 3 months
measure: Change in Pain Pressure Threshold
timeFrame: Change from baseline to 4 weeks and 3 months
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_DIRECTOR
References:
Clinical trial NCT01812343: Value of Ankle Pressure Index After Maximal Exercise Tests
Official title: Mesure de l'Index de Pression Systolique de Cheville après Test d'Effort Maximal.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Ankle Brachial Index
Maximal Exercise Test
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2013-03-18
Enrollment: 1760
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Estimate the response of ankle to brachial pressure index to incremental maximum exercise in subjects free from prior cardiovascular disease.

Estimate morbi-mortality of included patients over a 5 years follow up.


Eligibility criteria: Inclusion Criteria:

* 18 years old and more

Exclusion Criteria:

* patient with recent cardiovascular event

Primary outcomes:
measure: Mean value of post exercise ABI by age categories
timeFrame: up to 15min
Secondary outcomes:
measure: Prevalence of Morbi-mortality through self completed questionnaires
timeFrame: up to 5 year
Other outcomes:
Locations:
city: Angers
country: France
facility: UHAngers
Study officials:
affiliation: University Hospital, Angers
name: Pierre ABRAHAM, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Congnard F, Abraham P, Vincent F, Le Tourneau T, Carre F, Hupin D, Hamel JF, Vielle B, Bruneau A. Ankle to brachial systolic pressure index at rest increases with age in asymptomatic physically active participants. BMJ Open Sport Exerc Med. 2015 Nov 25;1(1):e000081. doi: 10.1136/bmjsem-2015-000081. eCollection 2015.
Clinical trial NCT02518243: Safe & Easy for Alzheimer's Disease and Related Pathologies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Deterioration
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 7
Sex: ALL
Minimum age (years): 60
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: All over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. Older individuals also frequently experience the reversible "frailty syndrome", which overlaps with chronic diseases, increasing incidence of disability.

Building a global system aiming to take in charge all causes leading to loss of autonomy is a rather complicated task involving numerous Information and Communication technologies (ICT) solutions which are not always easy to use in everyday life.

The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality of life of older people at risk.

The SafEE2 project develop non pharmacological therapeutic through diferent ICT (stimulation aromatherapy automatic fragrance ...) .

The goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.

Detailed description: The non pharmacological therapeutic will be install at hospital room :

* aromatherapy,
* music therapy,
* cognitive training in multimedia application offering cognitive games.

Eligibility criteria: Inclusion Criteria:

* Subjects with a diagnosis of Alzheimer's disease according to NINCDS-ADRDA (McKhann, Drachman et al. 1984) or typical or atypical Alzheimer's disease (Dubois B. et al. 2007).
* Score at Mini Mental Test (MMSE) ≥16.
* Subjects residing in nursing homes.
* Subjects beneficiaries of a social security scheme.
* Signature of free and informed consent.

Exclusion Criteria:

* Failure to pass the neuropsychological tests because of a sensory or motor deficit.
* Sensory deficit (olfactory or visual) preventing the patient made perfectly meet the therapeutic solutions.
* Prescription of a new treatment psychotropic (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week before the evaluation;
* Persons deprived of liberty (administrative or judicial).

Primary outcomes:
measure: Tolerance of the systems set up and use frequency evaluated using the Caregiver Questionnaire
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Ehpad Valrose
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Renaud DAVID, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00729443: Investigating Safety, Tolerability and Pharmakinetics When Giving Single and Fractionated Doses of AZD3241 to Healthy Volunteers
Official title: A Single-Centre, Placebo-Controlled, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD3241 Following Administration of Single Ascending (Part A) and Fractionated Ascending (Part B) Oral Doses to Young Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Single dose
Phase 1
Safety of AZD3241
tolerability of AZD3241
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study is carried out in order to investigate safety, tolerability and pharmacokinetics after administrating single and fractionated doses of AZD3241 to healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Body Mass Index (BMI) 19 to 30 kg/m2 inclusive
* Clinically normal physical findings, including BP, pulse rate, ECG and laboratory findings, as judged by the investigator

Exclusion Criteria:

* Clinically significant illness within the 2 weeks prior to the administration of the investigational product
* Heart rate (resting, recumbent) \<50 bmp or \>85 bmp
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity as judged by the investigator

Primary outcomes:
measure: General tolerability and safety variables
timeFrame: 2 weeks
Secondary outcomes:
measure: pk
timeFrame: approximately 48 hour
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: Astrazeneca Clinical Pharmacology Unit, Stockholm, Sweden
name: Ingemar Bylesjö
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02295943: Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
Official title: Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Macular Hole
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Haukeland University Hospital
name: Trondheim University Hospital
name: University Hospital of North Norway
First posted: 2014-11-20
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The macular hole formation takes place in the centre of the retina. A closure of the macular hole is believed to take place if the central retinal area is kept dry in the postoperative period. Therefore the eye is filled with a gas mix and the patients are urged to avoid the supine position in the first postoperative days. The investigators have developed a positioning measuring device which can measure the extent of supine positioning time. Patients are to carry the positioning measuring device during the first postoperative 24 hours. Hereby the investigators search new knowledge concerning patients compliance and its relation to macular hole closure.


Eligibility criteria: Inclusion Criteria:

* Primary macular hole
* Duration less than 24 months
* Informed consent

Exclusion Criteria:

* Secondary macular hole i.e. trauma, excessive myopia (more than 6 dioptres)
* Previous vitreomacular surgery
* Age under 18 years
* Unable to sign

Primary outcomes:
measure: Macular hole closure
timeFrame: 2 weeks
Secondary outcomes:
measure: Time in supine sleeping position
timeFrame: 1 day after enrollment
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: Trondheim University Hospital
Study officials:
affiliation: Stavanger University Hospital, Department of Ophthalmology
name: Vegard Forsaa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lindtjorn B, Krohn J, Austeng D, Fossen K, Varhaug P, Basit S, Helgesen OH, Eide GE, Forsaa VA. Nonsupine Positioning after Macular Hole Surgery: A Prospective Multicenter Study. Ophthalmol Retina. 2019 May;3(5):388-392. doi: 10.1016/j.oret.2018.12.006. Epub 2018 Dec 31.