louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04440852: Randomized, Controlled Trial of an Intervention for Preschool Children With Autism: TEACCH
Official title: Effect of TEACCH Program on the Rehabilitation Training for Preschool Children With Autistic Spectrum Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: TEACCH
Lead sponsor: Wuhan Mental Health Centre
Sponsor class: OTHER
Collaborators: name: Wuhan University
First posted: 2020-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 36
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is design to evaluate the efficacy of the Treatment and Education of Autistic and Communication Handicapped Children (TEACCH) on the rehabilitation for preschool children with autism spectrum disorders (ASD) in China.A case-randomized controlled study was conducted.Sixty children diagnosed with ASD between 36 and 90 months of age were randomly assigned to the a TEACCH intervention group or a control group.The control group was subjected to regular rehabilitation training, the TEACCH group carried out TEACCH training besides regular rehabilitation training for 6 months. Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3) was used to evaluate the effectiveness of TEACCH rehabilitation training.

Detailed description: Statistical analysis plan:The results were analyze using descriptive, t-test and ANOVA.

Eligibility criteria: Inclusion Criteria:

* diagnosed by two children's psychiatrists above the level of the attending physician, in accordance with the diagnostic criteria of DSM-V (Diagnostic and Statistical Manual of Mental Disorder, fifth revised) children's autism spectrum disorder issued by the United States in 2013. Diagnostic screening scales include Autism Behavior Checklist (ABC), Childhood Autism Rating Scale (CARS), and Modified Checklist for Autism in Toddlers (M-CHAT) (for under 4 years old), Social Communication Questionnaire (SCQ) (for over 4 years old), all children' scores above the scale suggest ASD performance;
* able to cooperate with clinical evaluation and related examinations, and the guardian signs the informed consent to agree to participate in the study.

Exclusion Criteria:

* combined with other mental illnesses such as ADHD, with major physical and nervous system diseases;
* serious self-harm.

Primary outcomes:
measure: Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)
timeFrame: pretest
measure: Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)
timeFrame: posttest: 6 months to pretest
measure: Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)
timeFrame: 6 months follow-up : 1 year to pretest
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Mental Health Centre
state: Hubei
Study officials:
affiliation: Wuhan Mental Health Centre
name: Hongling Zeng, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT02319252: Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases
Official title: Gastric- Versus Jejunal Feeding Tubes in Alcoholic Liver Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Liver Diseases, Alcoholic
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-12-18
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 study is an unblinded randomized trial, designed to examine whether gastric- or jejunal feeding tubes are the most effect full to feed patients with alcoholic liver diseases and non-sufficient oral intake.

The primary outcome will be differences in nutrition intake between the groups. Secondary outcomes will be: the amount of unplanned tube discontinuations; handgrip and patients' quality of life, nausea \& vomiting.

The study will include 40 patients at Aarhus University Hospital, Denmark.


Eligibility criteria: Inclusion Criteria:

* Alcoholic liver disease
* nutrition intake less than 75% of needed intake
* Signed informed consent form

Exclusion Criteria:

* Hepatic encephalopathy, grade 3 - 4
* Anatomic barriers to have a tube placed

Primary outcomes:
measure: Differences in nutrition intake
timeFrame: Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months
Secondary outcomes:
measure: Differences in patients reported outcomes
timeFrame: Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Central Region
Study officials:
affiliation: Aarhus University Hospital, Denmark
name: Palle Bager, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02852252: Solid Tumor Cancer Surgery With or Without Intraoperative Imaging: A Registry
Official title: Solid Tumor Cancer Surgery With or Without Intraoperative Imaging: A Registry Optional Sub-Study I: ICG Optional Sub-Study II: OTL38
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Gastric Cancer
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 291
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: Patients with a high clinical suspicion of cancer, scheduled to undergo surgery.

Brief summary: The study objective is to collect prospective data on cancer patients who undergo surgery and intraoperative imaging. The registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance.

Detailed description: Our objective is to collect prospective data on cancer subjects who undergo surgery and intraoperative imaging. The registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance.

In this protocol, subjects that receive intraoperative imaging will provide us the opportunity to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed. Also, we will monitor any side effects or potential toxicities that may occur. This data can then be used to predict if a subject is more likely to develop a local recurrence due to missed cancer cells, metastatic lymph nodes or synchronous lesions.

Eligibility criteria: Inclusion Criteria:

* Adult patients \>/= 18 years of age.
* Patients presenting with esophagogastric or bladder cancer.
* Good operative candidate as determined by the treating physician and/or multidisciplinary team.
* Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

* Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery.
* Vulnerable patient population.

Primary outcomes:
measure: Tissue to Background Ratio
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Sunil Singhal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00752752: The Acute Cardiovascular Effects of Marathon Running Using Magnetic Resonance Imaging
Official title: The Acute Cardiovascular Effects of Marathon Running Using Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Ischemia
Left Ventricular Systolic Dysfunction
Elevated Cardiac Enzymes
Keywords: Marathon Running
Cardiac Ischemia
Magnetic Resonance Imaging
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2008-09-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty-five (25) participants with plans of completing the Detroit Free Press Marathon in Detroit, Michigan on October 19, 2008.

Brief summary: Using blood testing and cardiac magnetic resonance imaging (MRI), the investigators aim to determine if there are necrotic areas of myocardium in participants who complete a marathon. In addition, the investigators aim to describe the acute and chronic structural abnormalities that occur as a result of endurance training. The study hypothesis is that myocardial necrosis is present in runners completing a marathon competition.

Detailed description: MARATHON-MI is a prospective, observational study of twenty-five (25) participants with plans of completing the Detroit Free Press Marathon in Detroit, Michigan on October 19, 2008. All participants will undergo a rigorous pre-marathon screening process which will include: 1) blood testing, 2) complete cardiopulmonary exercise testing, 3) ECG testing, 4) Holter monitoring, 5) cardiac MRI. Blood work will be check after the marathon immediately after and one day after the event. Cardiac MRI will be repeated within 12 hours of finishing the marathon. Using the information derived from the blood work and radiological testing, we will attempt to determine if there is an association between marathon running and myocardial necrosis.

Eligibility criteria: Inclusion Criteria:

* Detroit Free Press Marathon participant on October 19, 2008,
* Age \> 18 years old,
* Ability to provide informed consent.

Exclusion Criteria:

* Known coronary or structural heart disease
* Pregnancy,
* Extreme claustrophobia,
* Metal implants,
* Renal dysfunction.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: Physician
name: Justin E Trivax, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02740452: Anterior Cruciate Ligament Rupture
Official title: Ligamys Technique Versus Standard Technique for the Anterior Cruciate Ligament Rupture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Keywords: Rupture
Anterior Cruciate Ligament (ACL)
Laxity knee
Instability knee
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Société Mathys SA for sponsoring Ligamys Device
First posted: 2016-04-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The assess results of Anterior Cruciate Ligament (ACL) repair with the Ligamys® surgical technique versus standard technique.

The aim of the study is to compare (laxity, instability, and safety) these two types of treatment by using a prospective, randomised multicenter analysis.

Detailed description: The treatment of acute ruptures of the anterior cruciate ligament is surgical in some cases with ligamentoplasty technique.

Contrary to the classic ligamentoplasty, the treatment with Ligamys consists of promoting heating of the ligament itself by controlling mechanical environment.

It allows a "dynamic" stabilization of the torn Anterior Cruciate Ligament with in the 3 weekly following traumatism. These techniques may improve the recovery process, proprioceptive results, decrease morbidity of transplant harvesting and faster for the patients. It's all these issues we would like to assess with a randomised multicenter study.

Eligibility criteria: Inclusion Criteria:

* Age between 18 to 35 years
* Primary Anterior Cruciate Ligament rupture
* signed patient consent
* surgery 21 days or less after traumatism for Ligamys technique

Exclusion Criteria:

* infection of the operating site
* previous osseous disease
* pregnant or nursing woman.

Primary outcomes:
measure: Measuring anterior knee laxity with KT 1000 arthrometer
timeFrame: at 12 months
Secondary outcomes:
measure: Tegnér scores
timeFrame: at 12 months
measure: Lysholm scores
timeFrame: at 12 months
measure: IKDC score safety
timeFrame: at 12 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Stéphane DESCAMPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01361152: Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties (TKAs) in Patients With OA ≤50 Years Old
Official title: Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties in Patients With Osteoarthritis Younger Than Fifty Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: total knee arthroplasty
fixed-bearing
mobile-bearing
long-term
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2011-05-26
Enrollment: 216
Sex: ALL
Minimum age (years): 29
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the prospective study was to evaluate the minimum fifteen year follow-up of prospective total knee arthroplasties performed in patients younger than fifty years of age with osteoarthritis, using fixed- and mobile-bearing knee prostheses in the same patients, to compare

1. functional scores
2. rates of radiographic failure
3. revision rates
4. survivorship

Detailed description: The randomized prospective comparison of fixed- and mobile-bearing total knee designs in the same patients younger than fifty years of age is limited. The purpose of this study was to compare the long-term clinical and radiographic results of fixed- and mobile-bearing total knee arthroplasties in patients younger than fifty years of age with osteoarthritis.

Eligibility criteria: Inclusion Criteria:

* End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria:

* Inflammatory disease
* Patient with other Lower extremity disease which may affect functional outcome
* Neurologic disease effecting patients lower extremity
* Revision surgery
* Patient not medically cleared for bilateral surgery

Primary outcomes:
measure: Improvement in Knee Society Knee Score
timeFrame: 18 years
Secondary outcomes:
measure: Improvement in the range of motion
timeFrame: 18 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hosptial
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Young-Hoo Kim, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06635252: Statins, Cholesterol and Cognitive Decline in Alzheimer's
Official title: Statins, Cholesterol and Cognitive Decline in Alzheimer's
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Dementia
Statins
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2024-10-10
Enrollment: 2000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective cohort study based on data from the Stockholm Creatinine Measurements (SCREAM) project, linking laboratory data with SveDem-the Swedish Registry for Dementia Cognitive disorders, the National Patient Registry, the Swedish Prescribed Drug Registry, The Swedish Cause of Death Register and Health Insurance and Labour Market Studies (LISA). Dates between May 1, 2007, and October 16, 2018

Brief summary: Disturbances in brain cholesterol homeostasis may be involved in the pathogenesis of Alzheimer's disease (AD). Lipid-lowering medications could interfere with neurodegenerative processes in AD through cholesterol metabolism or other mechanisms. The investigators aim to estimate the causal effect of statins on cognitive function measured by MMSE and to identify the mediating or modifying effect of cholesterol between statins and cognitive function in patients with Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

All patients with AD and mixed dementia registered in SveDem and from SCREAM.

Exclusion Criteria:

* All patients with a missing MMSE score at diagnosis date will be excluded from the analyses.
* Patients with at least one measurement of low-density lipoprotein cholesterol (LDL-C) within 1 year before dementia diagnosis.

Primary outcomes:
measure: Cognitive decline
timeFrame: Through study completion, at least 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References:
Clinical trial NCT04356352: Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
Official title: A Comparison of Lidocaine, Esmolol, and Placebo Without Use of a Tourniquet for Relieving Pain From Intravenous Administration of Propofol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Injection Site Irritation
Pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: subjects randomized to receive either lidocaine, esmolol, or placebo immediately prior to the administration of propofol for their surgical procedure to treat injection site pain caused by propofol
Primary purpose: TREATMENT

Brief summary: The primary hypothesis is that esmolol and lidocaine, when given without the use of a tourniquet, provide relief of propofol injection pain that is superior to placebo when assessed using the propofol pain scoring tool

Detailed description: The study will include three arms: lidocaine, esmolol, and placebo. Eligible patients will be 18-60 years old, ASA physical status 1-3, and scheduled for an elective surgical procedure. Patients will be randomized to receive lidocaine, esmolol, or placebo. Both the patients and the administering/observing providers will be blinded to the study drug or placebo being administered

Eligibility criteria: Inclusion Criteria:

* 18-60 years of age
* ASA 1-3
* Elective surgical procedure

Exclusion Criteria:

* BMI ≥ 45
* Pregnancy
* Requirement for RSI or awake intubation
* Suspected or known difficult airway
* Contraindication to IV in either upper extremity
* Chronic pain syndrome including fibromyalgia
* Use of opioids, NSAIDs, or other analgesics within 24 hours (including preoperative PO Celebrex, Lyrica, Tylenol, etc.)
* Any use of opioids in the past three months
* Significant cardiopulmonary or hepatic dysfunction
* Hypersensitivity to study medications

Primary outcomes:
measure: Patient Pain Score
timeFrame: following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full induction
Secondary outcomes:
measure: Heart Rate
timeFrame: heart rate is measured each minute for the first 10 minutes following induction
measure: Systolic Blood Pressure
timeFrame: Systolic Blood Pressure is measured each minute for the first 10 minutes following induction
measure: Oxygen Saturation Percentage
timeFrame: Oxygen saturation measured each minute for the first 10 minutes following induction
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael Norton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05471752: Isolation, Characterization and Evaluation of the Potential of TissuE-resideNt cElls From Waste Musculoskeletal and Associated Connective Tissues
Official title: Isolation, Characterization and Evaluation of the Potential of TissuE-resideNt cElls From Waste Musculoskeletal and Associated Connective Tissues
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Musculoskeletal Diseases
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 742
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: males and females pateints, being ≥18 years old, undergoing elective surgery at IRCCS Istituto Ortopedico Galeazzi among which joint surgery (including hip or knee replacement), or anterior cruciate ligament (ACL) reconstruction or rotator cuff repair

Brief summary: The general purpose of this study is characterization of tissue-resident cells derived from different musculoskeletal and/or associated connective tissues (such as cartilage, synovial membrane, synovial fluid, bone, adipose tissue and tendons), in order to identify new strategies for the treatment of degenerative and inflammatory musculoskeletal disorders. Cells isolated from different tissue sources will be compared with each other by phenotypic and functional characterization, following culture and treatment with inflammatory elements, drugs and orthobiologics. Moreover, with the aim to assess predictive markers of therapeutic success, a correlation study of the content and properties of the cells isolated from different types of tissue with the clinical profile of the enrolled patients will be conducted.


Eligibility criteria: Inclusion Criteria:

* males and females

  * 18 years old
* patients undergoing elective surgery at IRCCS Istituto Ortopedico Galeazzi among which joint surgery (including hip or knee replacement), or anterior cruciate ligament (ACL) reconstruction or rotator cuff repair

Exclusion Criteria:

* age \< 18 years old
* patients unable to sign the Informed Consent
* positivity to virological test (HIV, HCV, HBV, TPHA)

Primary outcomes:
measure: Correlation beetween patients' age and cell yield
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
References: