louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02659371: Weight Loss Prior Mamma Reduction - A Pilot Study
Official title: Weight Loss by Low Energy Diet as Treatment Prior Mamma Reduction in Overweight Women - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Hypertrophy
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Due to a higher risk of complications, obese and overweight patients with macromastia are in Denmark prohibited mammoplasty , as BMI must be within normal range, i.e. BMI \< 25 kg/m2.

The study is a pilot study with a diet intervention group and no control group. The intervention is a 12 week low energy diet pre-operative weight loss program investigating if this will result in weight loss making the overweight and obese patients eligible for breast reduction surgery i.e. BMI \< 25.


Eligibility criteria: Inclusion Criteria:

* entitled to mammoplasty,
* motivated towards participation in a weight loss program
* BMI within the range 25.5 to 35 kg/m2

Exclusion Criteria:

* more than 65 years of age
* insulin-dependent diabetes
* chronic heart, liver or kidney failure

Primary outcomes:
measure: Weight loss
timeFrame: 12 weeks
Secondary outcomes:
measure: Breast volumen
timeFrame: 12 weeks
measure: Breast size
timeFrame: 12 weeks
measure: Pain and discomfort
timeFrame: 12 weeks
Other outcomes:
measure: Blood bio markers
timeFrame: 12 weeks
measure: Hip circumference
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 12 weeks
Locations:
city: Herlev
country: Denmark
facility: Copenhagen University Hospital at Herlev (EFFECT)
Study officials:
affiliation: University of Copenhagen
name: Arne Astrup, MDDrMedSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01100671: Comparison of 18F-fluorodeoxyglucose Positron Emission Tomography and Coronary Computed Tomography in Assessing Vascular Inflammation
Official title: Comparison of 18F-fluorodeoxyglucose Positron Emission Tomography and Coronary Computed Tomography in Assessing Vascular Inflammation in Healthy Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Keywords: atherosclerosis
vascular inflammation
MDCT
18FDG-PET
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2010-04-09
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy participants who underwent a medical health check in the health promotion center in Korea Guro University

Brief summary: Vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.cardiac multidetector-row CT can provide measurements of coronary artery calcium (CAC), the degree of stenosis, and the characteristics of plaque including its potential vulnerability. Therefore, the purpose of the investigators study is to compare the usefulness of 18 FDG-PET and MDCT in assessing the vascular inflammatory status and vulnerability.


Eligibility criteria: Inclusion Criteria:

* Healthy patients for visiting routine medical check in our clinic

Exclusion Criteria:

* History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
* Diabetes
* Stage 2 hypertension (resting blood pressure, ≥ 160/100 mmHg)
* Malignancy
* Severe renal or hepatic disease
* Subjects taking medications that might affect inflammation such as NSIAD and statin

Primary outcomes:
measure: Correlation between vascular inflammatory status measured by 18FDG PET and MDCT
timeFrame: 20weeks
Secondary outcomes:
measure: Comparison the correlation with inflammatory marker and vascular inflammatory status assessed by 18FDG PET and MDCT
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hye Jin Yoo
Study officials:
affiliation: Korea University
name: Kyung Mook Choi, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yoo HJ, Yong HS, Hwang SY, Eo JS, Hong HC, Seo JA, Kim SG, Kim NH, Choi DS, Baik SH, Choi KM. Association of pooled cohort risk scores with vascular inflammation and coronary artery calcification in Korean adults. Metabolism. 2016 Mar;65(3):1-7. doi: 10.1016/j.metabol.2015.10.016. Epub 2015 Oct 22.
Clinical trial NCT00338871: Home Based Exercise Program for Brain Injury Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury
Cerebral Palsy
Lead sponsor: Alyn Pediatric & Adolescent Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2006-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether simple home-base aerobic exercise program have beneficial effect on walking abilities and balance performance in children with brain damage


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of CP or ABI Must be able to stand with or without aid.

Exclusion Criteria:

Can not follow simple commands

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Alyn Pediatric and Adolesencent Rehabilitation Center
Study officials:
affiliation: Alyn Hospital Jerusalem
name: Michal Katz-Leurer, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06207071: Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Official title: Early DHA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant Malnutrition
Light-For-Dates With Signs of Fetal Malnutrition
Premature
Nutrition Disorder, Infant
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Mead Johnson Nutrition
First posted: 2024-01-16
Enrollment: 152
Sex: ALL
Minimum age (years): 24
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Growth-restricted very preterm infants (VPT) are born without adequate fat mass (FM) deposits and low docosahexaenoic acid (DHA) concentrations. They often experience further declines in DHA concentrations during the initial three weeks post-birth while advancing enteral feeds and receiving lipid supplementation predominantly through parenteral nutrition. These suboptimal enteral and parenteral nutrition practices significantly heighten the risk of faltering postnatal growth. One promising approach to mitigate these issues is enteral DHA supplementation. However, it remains unclear whether the early administration of DHA through enteral supplementation could lead to a more substantial increase in head growth without affecting FM accretion in growth-restricted VPT infants. To address this question, we propose a masked randomized clinical trial involving 152 VPT infants.


Eligibility criteria: Inclusion Criteria:

* Gestational ages between 22 0/7 - 32 6/7 weeks gestation
* \< 25th centile birthweight

Exclusion Criteria:

* Major congenital/chromosomal anomalies
* Terminal illness in which decisions to withhold or limit support have been made

Primary outcomes:
measure: Head circumference at 36 weeks postmenstrual age or discharge
timeFrame: Birth to 36 weeks postmenstrual age or discharge
Secondary outcomes:
measure: Fat mass(FM)-for-age Z-score
timeFrame: Birth to 36 weeks postmenstrual age
measure: Changes in serum metabolic profile at 36 weeks postmenstrual age
timeFrame: 36 weeks postmenstrual age or discharge
Other outcomes:
measure: Cognitive outcomes
timeFrame: 2 years of age
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT05909371: Investigation of the Effects of Motor Cognitive Dual Task Exercises on Cognitive Function, Balance and Functional Capacity in Patients Who Have Undergone Liver Transplantation.
Official title: Physiotherapy and Rehabilitation Doctoral Thesis Work
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Transplantation
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Liver transplantation is a life-saving treatment of choice for patients with acute or chronic liver failure. Liver transplantation is performed with a graft taken from a living donor or cadaver in patients with end-stage liver failure or who develop various complications regardless of the stage of the disease.In liver diseases, cognitive problems occur as well as physical problems. It has been observed that in some liver diseases, including hepatitis C, Wilson's disease, primary biliary cirrhosis, cognitive dysfunction that negatively affects the quality of life of patients, from mild cognitive problems to hepatic encephalopathy.

Our study will be carried out in Malatya İnönü University Turgut Özal Medical Center Liver Transplant Institute Hospital in order to investigate the effects of motor-cognitive dual-task exercises on cognitive function, balance and functional capacity in liver transplant patients.It will be divided into 2 groups as classical physiotherapy and motor-cognitive exercise. Classical physiotherapy and motor-cognitive exercise programs will be applied to the groups in accordance with the clinical characteristics of the individuals, tolerable, and in a standardized manner specific to the individuals. Evaluations will be made on the first day and at the end of the twenty-fourth session while the patient is in the service before starting the treatment.


Eligibility criteria: Inclusion Criteria:

* Volunteering to participate
* Having performed a liver transplant over the age of 50
* Spontaneous breathing
* Being hemodynamically stable
* Ability to read and write
* Not having an orthopedic disability and functional capacity limitation
* Being conscious and cooperative

Exclusion Criteria:

* Not agreeing to participate in the study
* Not continuing the treatment regularly
* Having neurological or neuropsychiatric problems
* Being colorblind

Primary outcomes:
measure: Evaluation of Cognitive Functions
timeFrame: One day
measure: Evaluation of Cognitive Functions
timeFrame: One day before the rehabilitation
measure: Evaluation of Balance
timeFrame: One day before the rehabilitation
measure: Evaluation of Balance
timeFrame: One day
measure: Assessment of functional capacity
timeFrame: One day before the rehabilitation
measure: Assessment of functional capacity
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
References:
Clinical trial NCT00005771: The Use of Real Time Ultrasound Feedback in Teaching Abdominal Hollowing Exercises
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Low Back Pain
Keywords: Abdominal Hollowing Exercises
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-06-02
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recently, physical therapists have begun treating people who have mechanical low back pain, hypothesized to be caused by segmental instability in the lumbar spine, with a very specific exercise program consisting of trunk stabilization exercises. The theory behind the use of trunk stabilization exercises to treat lower back pain is that active contraction of the trunk local segmental muscles helps to control inter-segmental movement in the spine. The initial trunk stabilization exercise that physical therapists teach patients is an abdominal drawing in maneuver often called an abdominal hollowing exercise (AHE). A challenge for physical therapists is to establish the most effective means of teaching people to contract the relevant muscles needed to perform the AHE. The purpose of this study is to examine if supplementing the typical clinical instruction for teaching the AHE with visual ultrasound feedback to the patient is effective at reducing the length of time it takes an individual to learn to perform an AHE.

Three groups of research volunteers will be taught how to do the AHE while receiving different kinds of feedback about their performance in order to determine which type of feedback is most effective in assisting people to learn the AHE. Group 1 will not receive any feedback about performance; Group 2 will receive feedback from palpation and verbal descriptive alone; and Group 3 will receive feedback from palpation, verbal descriptive feedback, and real time ultrasound. For the initial test when subjects are learning the AHE, the number of trials until the subject demonstrates his/her third correct AHE will be the outcome variable. For the retention test, the outcome variable will be the percentage of trials (out of ten) of correctly performed AHEs in the absence of visual, verbal or palpation feedback.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References:
Clinical trial NCT03239171: Bioinformation Therapy for Lung Cancer
Official title: Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Small-cell Lung Cancer
Keywords: Cancer ablation
Life information rehabilitation therapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shengxin Biotechnology Institute, Beijing
First posted: 2017-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable lung cancer.

Detailed description: By enrolling patients with unresectable lung cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies
* Body tumor 1-6, with at least one tumor length \> 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT02478671: Magnetic Resonance Imaging (MRI) to Assess Radial Artery Compression and Arterial Perfusion While TR Band is Applied
Official title: Magnetic Resonance Imaging (MRI) to Assess Radial Artery Compression and Arterial Perfusion While TR Band is Applied
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Peripheral Perfusion
Lead sponsor: Terumo Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Medical University of South Carolina
First posted: 2015-06-23
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Subjects' radial artery diameters and plethysmography waveforms will be recorded by MRI and pulse oxymetry at varying levels of radial artery compression by the Terumo TR Band.

Detailed description: In this study, the diameter of each subjects' radial artery will be measured using MRI imagery at varying degrees of radial artery compression by adjusting the amount of air injected into a Terumo TR Band. In addition, using pulse oxymetry, the perfusion waveform will be measured and recorded also while the subjects have a TR Band in place on their wrists.

Eligibility criteria: Inclusion Criteria:

1. Female or male adult (has reached the legal majority age).
2. Subject has provided his/her written informed consent to participate in the trial prior to any study -related procedure being conducted.

Exclusion Criteria:

1. Abnormal result of either baseline Barbeau or reverse Barbeau tests.
2. Pregnant or breast feeding female.
3. Subject with contraindication to MRI

Primary outcomes:
measure: MRI Based Radial Artery Measurement
timeFrame: Subjects will be followed up to one week post procedure
Secondary outcomes:
measure: Hand Perfusion as Measured by Pulse Oxymetry Waveform
timeFrame: Subjects will be followed up to one week post procedure
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Marcelo Guimaraes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05484271: Relationship Between the Arthroscopic Anatomy of the Middle Glenohumeral Ligament and the Rotator Cuff Tear Position
Official title: Relationship Between the Arthroscopic Anatomy of the Middle Glenohumeral Ligament and the Rotator Cuff Tear Position
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rotator Cuff Tears
Keywords: Rotator Cuff Tears
Middle Glenohumeral Ligament
Arthroscopic Anatomy
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rotator cuff tears received the arthroscopic rotator cuff repair.

Brief summary: The main aim and scope of this study is making observation and comparing the difference in the tear position in the patients suffered form rotator cuff tear with different arthroscopic anatomy of the middle glenohumeral ligament. The results may identify the influence of the middle glenohumeral ligament anatomy type on the rotator cuff tear.


Eligibility criteria: Inclusion Criteria:

* partial or full-thickness but reparable rotator cuff tear;
* small- to large-sized rotator cuff tears being defined by DeOrio and Cofied4;
* no improvements after at least 1 month of conservative treatment such as NSAIDs or corticosteroid injection.

Exclusion Criteria:

* massive rotator cuff tears being defined by DeOrio and Cofied;
* patients with osteoarthritis of the glenohumeral joint;
* trauma or a history of surgery at the shoulder.

Primary outcomes:
measure: The arthroscopic tear position (Anetrior/Middle/Posterior)
timeFrame: During the surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02711371: Social and Emotional Brain Function in Cannabis Users
Official title: Long-term Effects of Cannabis Use on Social and Emotional Brain Processes in Dependent Cannabis Users After a 28 Day Abstinence Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cannabis Dependence
Keywords: addiction
cannabis
fMRI
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: University Hospital, Bonn
First posted: 2016-03-17
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cannabis dependent individuals

Brief summary: The aim of this functional magnetic resonance imaging (fMRI) study is to find out whether and how social and emotional brain function are altered in dependent cannabis users relative to healthy non-using control subjects after a 28 supervised abstinence period. Previous research in cannabis users has predominantly focused on cognitive functions. Moreover, studies have implicated that observed deficits in cannabis users may regenerate after a prolonged abstinence period. Findings might provide important information with respect to relapse vulnerability.


Eligibility criteria: Inclusion Criteria:

* Cannabis dependence according to DSM 4 criteria
* 28 days of supervised abstinence

Exclusion Criteria:

* other DSM 4 diagnosis
* neurological disorders

Primary outcomes:
measure: fMRI neural activation patterns of social-emotional brain processes after 28 day abstinence
timeFrame: one timepoint = fMRI assessment after 28 day abstinence period
Secondary outcomes:
measure: Ratings of subjective experience (pleasantness, rewarding value) will be assessed after 28 days of abstinence
timeFrame: one timepoint = during fMRI assessment after 28 day abstinence period
measure: Relapse interview assessed with Timeline-Followback Method
timeFrame: one timepoint = 24 months post-fMRI-session
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn / Department of Psychiatry
state: NRW
Study officials:
References:
citation: Zimmermann K, Yao S, Heinz M, Zhou F, Dau W, Banger M, Weber B, Hurlemann R, Becker B. Altered orbitofrontal activity and dorsal striatal connectivity during emotion processing in dependent marijuana users after 28 days of abstinence. Psychopharmacology (Berl). 2018 Mar;235(3):849-859. doi: 10.1007/s00213-017-4803-6. Epub 2017 Dec 2.