louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02346019: Thigh Reduction Surgery of Above Knee Amputee Residual Limbs to Improve Prosthesis Fit and Patient Outcomes
Official title: Thighplasty of Transfemoral Amputee Residual Limbs to Improve Prosthesis Fit and Patient Functional Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transfemoral Amputees
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of our study is to improve the fit and function of prosthetic sockets for above the knee amputees through the use of an outpatient thigh reduction surgical procedure.

Detailed description: We will quantify the anatomical distribution of subcutaneous fat, muscle and bone in the residual limb of the transfemoral amputees with an MRI. We will measure the displacement of the socket wall relative to the femur under mechanical loading with x-ray. The functional mobility level of the subject with be quantified via standard clinical and bio mechanical tests. Perform a standard medial thighplasty with our without thigh liposuction. Characterize the post-surgical anatomy, compliance of the residual limb and function of the amputee subjects. After six months, repeat the MRI and xray and compare results. Subject will also complete a questionnaire regarding their views on the outcome of the surgery.

Eligibility criteria: Inclusion Criteria:

* Obese transfemoral amputees with a BMI of at least 30.
* Mid to long residual limb, excessive adipose tissue in their residual limb
* Community ambulators
* Adults over the age of 18

Exclusion Criteria:

* Amputation due to vascular disease or diabetes
* Cognitive impairments that would interfere with the protocol or patient safety
* Systemic disease that is not stable or would significantly increase the risk of complications with surgery
* Chronic wounds
* People who do not ambulate on a daily basis
* Children under the age of 18.

Primary outcomes:
measure: Assess compliance of residual limb in the socket, which will improve the fit and comfort of the prosthesis.
timeFrame: Pre surgery and 6 months post surgery
Secondary outcomes:
measure: Assess walking endurance
timeFrame: Pre surgery and 6 months post surgery
measure: Assess balance stability
timeFrame: Pre surgery and 6 months post surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Todd A Kuiken, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02222519: Interaction of Statins and Nondepolarizing Muscle Relaxants
Official title: Interaction of Statins and Nondepolarizing Muscle Relaxants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Keywords: statins
nondepolarizing muscle relaxants
rocuronium
myalgia
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2014-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.

Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months

Brief summary: provide evidence for prevention or reduction muscle pain.

Detailed description: The purpose of this study is to determine interaction of statins and nondepolarizing muscle relaxant,In order to provide evidence for prevention or reduction muscle pain.

Eligibility criteria: Inclusion Criteria:

* Patients with American Society of Anesthesiologists physical status I-III
* Patients taking statins for at least 3 months and those who had never used statins were considered to be eligible

Exclusion Criteria:

* Orthopedic
* Spinal surgery
* Surgery involving extensive muscle manipulation
* History of liver and kidney failure
* Neuromuscular disease
* Susceptibility to or family history of malignant hyperthermia
* Extensive denervation of skeletal muscle
* Chronic pain syndromes
* Taking medications that might interact with the effect of rocuronium or serum myoglobin difficult intubation

Primary outcomes:
measure: plasma myoglobin concentration
timeFrame: 20 minutes after administration
Secondary outcomes:
measure: muscle pain
timeFrame: 2 and 24 hours postoperatively
measure: serum potassium concentration
timeFrame: 2 and 24 hours postoperatively
measure: plasma creatine phosphokinase concentration
timeFrame: 2 and 24 hours postoperatively
measure: urine myoglobin and onset plus duration of succinylcholine block
timeFrame: 2 and 24 hours postoperatively
Other outcomes:
Locations:
city: Shenyang
country: China
facility: China Medical University
state: Liaoning
Study officials:
affiliation: the Anesthesiology Department
name: Huangwei Lv, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02491619: Correlation Between Dental Inclination and Bone Thickness in Patients With Class III Dentofacial Deformities
Official title: Correlation Between Buccolingual Dental Inclination and Bone Thickness After Orthodontic Decompensation in Patients With Class III Dentofacial Deformities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentofacial Deformities
Keywords: Angle class III
tomography
tooth inclination
bone thickness
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The correlation between tooth inclination and bone thickness and the comparison between thickness measurements and buccolingual inclination before and after dental decompensation will be evaluated through tridimensional images in individuals with class III dentofacial deformities.

Detailed description: Class III dentofacial deformity is associated with important functional, psychological and aesthetic changes and thus individuals affected by this type of deformity are motivated in seeking treatment. The sample will consist of three-dimensional images of 40 individuals with Class III dentofacial deformities. From these images generated by CBCT scans, the buccolingual inclinations of all teeth and maxillo-mandibular alveolar bone thickness in three different heights will be measured (3, 6 and 8 mm) from the cementoenamel junction through the Dolphin 3D® program. The 3D scans of the sample will be evaluated in two stages: the initial stage and after dental decompensation at the end of pre-surgical orthodontic phase. Pearson correlation test will be used to verify the relationship between tooth inclination and bone thickness. The thickness measurements and buccolingual inclination will be compared between treatment times (initial and pre-surgical) using paired Student t-test.

Eligibility criteria: Inclusion Criteria:

* Brazilian nationality;
* Class III malocclusion, for molars and canines;
* Concave facial profile;
* Indications for orthodontic-surgical treatment;
* Craniofacial growth finalized ;
* Absence of tooth extractions;
* No local and / or general contraindications for surgery;
* No previous orthodontic-surgical treatment;
* Good dental and periodontal conditions.

Exclusion Criteria:

* Facial asymmetry;
* Absence of teeth (except the third molars);
* Periodontal disease and vertical or horizontal bone resorption;
* Extensive metal restorations;
* Previous orthodontic treatment;
* Root anomalies.

Primary outcomes:
measure: Change in tooth inclination and bone thickness after tooth decompensation
timeFrame: 12 months after the begginning of orthodontic treatment, prior to orthognathic surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: José Rino Neto, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05125419: Homocysteine in Acute Coronary Syndrome
Official title: Serum Homocysteine Level in the Setting of Acute Coronary Syndrome in Young Adult Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presented with acute coronary syndrome admitted to coronary care unit of Sohag University hospital according to inclusion and exclusion criteria

Brief summary: This study aims to determine the relation between high homocysteine levels and increased incidence of acute coronary syndrome in young patients

Detailed description: Cross sectional study to:

assess homocysteine level in young adult patients presenting with acute coronary syndrome

Eligibility criteria: Inclusion Criteria:

1. - The patients who presented in the hospital with chest pain consistent with acute coronary syndrome with any of the following features:

   1. Electrocardiogram (ECG) changes:

      * ST elevation
      * ST depression
      * T wave inversion
      * recent left bundle branch block
   2. Troponin T elevation (Norma value \< 0.06)

      2- Age: -Between 18- 40 years (Group A) - Age \> 40 years (Group B)

      Exclusion Criteria:
      1. Chest pain not consistent with acute coronary syndrome
      2. Chronic kidney disease (CKD)
      3. Rheumatic heart disease (RHD)
      4. Congenital heart disease
      5. Anemia
      6. Cancer

Primary outcomes:
measure: Coronary care unit admission with acute coronary syndrome
timeFrame: From date of randomization up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Sohag University
name: Mohammed E Amin, Lecturer
role: STUDY_CHAIR
References:
citation: Liu J, Quan J, Li Y, Wu Y, Yang L. Blood homocysteine levels could predict major adverse cardiac events in patients with acute coronary syndrome: A STROBE-compliant observational study. Medicine (Baltimore). 2018 Oct;97(40):e12626. doi: 10.1097/MD.0000000000012626.
Clinical trial NCT05963919: Determinants of Functional Capacity in Children With Asthma
Official title: Determinants of Functional Capacity in Children With Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma in Children
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with asthma aged between 6-17 years and healthy children aged between 6-17 years will be included in the study. Informed consent forms for the study prepared for both the asthma group and the control group will be carefully explained and the participants will be included in the study after they and their parents have read, understood, and accepted.

Brief summary: The primary aim of this study is to compare the respiratory function, respiratory muscle strength, functional capacity, and lower extremity strength of children with asthma and healthy children in the same age group. The secondary aim of our study is to determine the determinants of functional capacity in children with asthma.


Eligibility criteria: Asthma Group Inclusion Criteria:

* Being between the ages of 6-17
* Being diagnosed with asthma
* Able to walk, cooperate and clinically stable
* Being a volunteer to participate in the study
* To be able to speak, read, understand, and cooperate in Turkish

Asthma Group Exclusion Criteria:

* History of previous lung or liver transplant
* Having an acute exacerbation and/or a history of hospitalization in the last 1 month
* Having diagnosed orthopedic problems affecting mobility or a history of musculoskeletal surgery

Control Group Inclusion Criteria:

* Being between the ages of 6-17
* To be able to speak, read, understand, and cooperate in Turkish
* Being a volunteer to participate in the study

Control Group Exclusion Criteria:

* Having a diagnosed vision, hearing, or neurological disease that may affect balance
* Having any other neurological, orthopedic, cardiovascular, thoracic, or metabolic disease or pathological condition that would affect assessments
* Resting saturation below 90% during exercise tests

Primary outcomes:
measure: 6-minute walk test
timeFrame: 15-20 minutes
measure: Forced expiratory volume in 1 second (FEV1)
timeFrame: 10-15 minutes
measure: Peak expiratory flow (PEF)
timeFrame: 10-15 minutes
measure: Maximal inspiratory pressure (MIP)
timeFrame: 15-20 minutes
measure: Maximal expiratory pressure (MEP)
timeFrame: 15-20 minutes
measure: Lower extremity muscle strength
timeFrame: 5-10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Atlas University
Study officials:
References:
Clinical trial NCT05872919: Telenhealth and Adherence to Stains
Official title: Telehealth and Challenges in Statin Adherence in Patients With Diabetes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telehealth , Lipid Lowering Medication Adherence
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be offered to participate. Willing patients will be randomly assigned to one of two groups: Two arms study design: first arm (control group)won't receive intervention while the second arm (intervention group) will receive telenursing intervention through SMS; Is a text messages will be sent to the intervention group comprised of a reminder on when, how to take lipid lowering medication, benefits, and adverse effect of not taken the drug as prescribed for three months duration. SMS (Short Messaging Service) will be sent three times per week in the first six weeks and twice per week in the second six weeks.
Primary purpose: OTHER

Brief summary: To evaluate the effect of telehealth through short messaging services (SMSs) on adherence to statins in patients with diabetes.


Eligibility criteria: Inclusion Criteria:

* Adult (≥18 years)
* Both sexes
* Type 1 and 2 diabetes
* Had a prescription of lipid lowering medication with a minimum duration of two weeks
* Have an active contact phone number that can receive text messages
* Able to read SMS text messages (patient, or family member)

Exclusion criteria:

* Communication impairment
* Taking any psychotropic medications
* Familial hypercholesterolemia
* Already established coronary heart disease
* not on lipid lowering medication

Primary outcomes:
measure: Adherence rate
timeFrame: 6 and 12 weeks
measure: Adherence rate
timeFrame: 6 and 12 weeks
Secondary outcomes:
measure: Lipid profile
timeFrame: at 12 week
measure: Acute cardiovascular events (CVE)
timeFrame: at 12 weeks
measure: Mortality
timeFrame: at 12 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Nursing
Study officials:
References:
Clinical trial NCT00658619: Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)
Official title: Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Degeneration
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-04-15
Enrollment: 119
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1. Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from age-related macular degeneration. Patients will be followed for up to 2 years.


Eligibility criteria: Inclusion Criteria:

* Geographic atrophy in both eyes due to age-related macular degeneration
* Visual acuity between 20/40 to 20/320

Exclusion Criteria:

* Known allergy to brimonidine
* Uncontrolled systemic disease or infection of the eye
* Recent eye surgery or injections in the eye
* Female patients who are pregnant, nursing or planning a pregnancy

Primary outcomes:
measure: Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
timeFrame: Baseline, Month 3, Month 6, Month 9, Month 18, Month 24
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, 24 Months
measure: Change From Baseline in Contrast Sensitivity in the Study Eye
timeFrame: Baseline, 24 Months
measure: Change From Baseline in Reading Speed in the Study Eye
timeFrame: Baseline, 24 Months
Other outcomes:
Locations:
city: Abilene
country: United States
state: Texas
city: Sydney
country: Australia
state: New South Wales
city: Karlsruhe
country: Germany
city: Udine
country: Italy
city: Seoul
country: Korea, Republic of
city: Makati City
country: Philippines
city: Coimbra
country: Portugal
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kuppermann BD, Patel SS, Boyer DS, Augustin AJ, Freeman WR, Kerr KJ, Guo Q, Schneider S, Lopez FJ; Brimo DDS Gen 1 Study Group. PHASE 2 STUDY OF THE SAFETY AND EFFICACY OF BRIMONIDINE DRUG DELIVERY SYSTEM (BRIMO DDS) GENERATION 1 IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2021 Jan 1;41(1):144-155. doi: 10.1097/IAE.0000000000002789.
Clinical trial NCT03392519: Brain Imaging Study of Brain Plasticity in Chronic Stroke Patients
Official title: Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging Study About Reorganization and Recovery Mechanism of Brain Neural Network for Chronic Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Stroke
Keywords: Brain connectivity
Magnetic resonance imaging
Brain plasticity
Recovery
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 59
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A person who was inpatient at subacute stage at the Samsung Medical Center.

Brief summary: In chronic stroke patients, brain network reorganization and recovery mechanism are investigated after stroke onset using functional MRI and diffusion tensor imaging analyses.


Eligibility criteria: Inclusion Criteria:

* more than 3 months post-stroke
* ischemic or hemorrhagic stroke
* a person who understands the experiment and has a willingness to participate and signs the agreement

Exclusion Criteria:

* User of artificial heartbeat
* Patients with claustrophobia
* Patients with metal implants
* Patients who are contraindicated for other common MRI

Primary outcomes:
measure: Correlation coefficient between strength of connection and the Fugl-Meyer Assessment score
timeFrame: Through study completion, an average of 1 year
measure: Correlation coefficient between the FA value of a tract and the Fugl-Meyer Assessment score
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT03594019: Immediate Implant Placement With Connective Tissue Graft or Socket Shield
Official title: Immediate Implant Placement Without Connective Tissue Graft or Socket Shield: a Randomized Controlled Clincial Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Tooth Fractures
Keywords: immediate implant placement
connective tissue graft
samll dehiscence
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 40
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: The present study aims to evaluate the clinical outcomes of immediate implant placement with connective tissue graft or socket shield. Previous studies have demonstrate the intact buccal bone plate plays an important role in the stability of peri-implant soft tissue around immediately placed implants. However, it remains controverisal whether soft tissue stability could be achieved in immediate implant placement with connective tissue graft or socket shield.


Eligibility criteria: Inclusion Criteria:

* Patients in need of single implant treatment in anterior maxilla Patients with small dehiscence in the buccal bone plate （\<2mm vertical bone loss and \<5mm horizontal bone loss） Patients with natural teeth adjacent to implant site

Exclusion Criteria:

* Uncontrolled periodontal diseases Heavy smokers (\>10 cigarettes/day) Unwilling to participate in the present study

Primary outcomes:
measure: pink esthetic score （PES）
timeFrame: 1 year
Secondary outcomes:
measure: mucosal recession
timeFrame: 1 year
measure: marginal bone loss
timeFrame: 1 year
measure: pocket probing depth
timeFrame: 1 year
measure: bleeding on probing
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
Study officials:
References: