louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01708135: Feasibility of Use of BariCare App in Pre-bariatric Surgery.
Official title: Feasibility and Efficacy of Engagement Modules for Pre-Bariatric Surgery Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This current study aims to evaluate the efficacy of engagement modules in preparing patients for bariatric surgery. With the help of the Center for Innovation (CFI), a smartphone app (Android and Apple compatible) has been created that will assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged during the lengthy pre-bariatric surgery process.


Eligibility criteria: Inclusion Criteria:

1. Patients, who upon completion of an evaluation by Endocrinology, are considered appropriate to pursue a primary, laparoscopic bariatric surgery.
2. Patients who are 18 years of age or greater.
3. Patients who own a smartphone.

Exclusion Criteria:

1. Patients with a history of a prior bariatric surgery.
2. Patients with active psychiatric disorder(s).
3. Patients with active tobacco use.
4. Patients with active substance use (alcohol, illicit drugs, etc.)

Primary outcomes:
measure: Smart phone app feasibility
timeFrame: 3 months
Secondary outcomes:
measure: Ease of use of app
timeFrame: 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Manpreet Mundi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00942435: A Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
Official title: A Randomized, Open Label Parallel Group Mechanical Prophylaxis Controlled Comparison Study With YM150, a Direct Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: YM150
Bleeding
VTE
FXa inhibitor
Deep Vein Thrombosis
Venous thromboembolism
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-07-20
Enrollment: 156
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the efficacy and safety of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients undergoing major abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* Patients after a major abdominal surgery
* Written informed consent obtained

Exclusion Criteria:

* Subject has history of symptomatic deep vein thrombosis and/or pulmonary embolism
* Subject has a hemorrhagic disorder and/or coagulation disorder
* Subject has had clinically important bleeding occurred within 90 days prior to the screening visit
* Subject has an active bacterial endocarditis
* Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke
* Subject is receiving anticoagulants/antiplatelet agents
* Subject has a thrombocytopenia
* Body weight less than 40 kg at the screening

Primary outcomes:
measure: Composite assessment of venous thromboembolism events and all causes of death
timeFrame: Until day 12
Secondary outcomes:
measure: Incidence of venous thromboembolism
timeFrame: Until day 28
measure: Incidence of bleeding events
timeFrame: Until day 28
measure: All cause mortality
timeFrame: Until day 28
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Shikoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: Sakon M, Nakamura M. Darexaban (YM150) prevents venous thromboembolism in Japanese patients undergoing major abdominal surgery: Phase III randomized, mechanical prophylaxis-controlled, open-label study. Thromb Res. 2012 Sep;130(3):e52-9. doi: 10.1016/j.thromres.2012.06.009. Epub 2012 Jul 2.
Clinical trial NCT03385135: Allopurinol and Endothelial Function in Diabetic CAD Patients
Official title: Impact of ALLopurInol on Endothelial fuNCtion in diabEtic Patients Affected With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Coronary Artery Disease
Keywords: allopurinol
coronary artery disease
diabetes
endothelial function
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 58
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: This is a randomized trial assessing the impact of allopurinol on endothelial function in optimally treated diabetic patients with coronary artery disease. After initial screening, subjects were randomized to receive either optimal medical therapy (OMT) + allopurinol or OMT alone for 8 weeks. The dose of allopurinol was 300 mg for 4 weeks and 600 mg for 4 weeks with a 4-weekly check on hematology and biochemistry


Eligibility criteria: Inclusion Criteria:

* Diabetes type 2
* Known coronary artery disease with previous percutaneous coronary intervention and optimal medical therapy for at least one month

Exclusion Criteria:

* Pregnant or breast- feeding women
* creatinine clearance \<60ml/min
* Known history of gout disease or ongoing treatment with allopurinol
* Allergy to allopurinol
* Inability to provide informed consent

Primary outcomes:
measure: Endothelium-dependent vasodilation
timeFrame: 2 months
Secondary outcomes:
measure: Endothelium-independent vasodilation
timeFrame: 2 months
measure: Quality of Life (QoL)
timeFrame: 2 months
measure: Major adverse cardiac events (MACE)
timeFrame: 2 months
Other outcomes:
Locations:
city: Ariana
country: Tunisia
facility: Cardiology Department, Abderrahmen Mami Hospital
Study officials:
affiliation: Cardiology Department, Abderrahmen Mami Hospital, 2008, Ariana
name: Salem Kachboura, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01102335: Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy
Official title: The Observation Of Safety And Survival Of Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization Combined With Anti-hepatitis B Virus Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Keywords: hepatitis B virus
Antiviral Agents
Liver Neoplasms
Drug Toxicity
Survival
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to elucidate the influence of anti-hepatitis B virus therapy on safety and survival of HCC patient after transcatheter arterial chemoembolization.


Eligibility criteria: Inclusion Criteria:

* hepatocellular carcinoma
* treated with transcatheter arterial chemoembolization (TACE)
* HBVDNA \> 10\^3copies/mL, including alanine aminotransferase (ALT) normal patient
* expected survive time \> 1 year
* HBV marker positive (anyone of HbsAg, HbsAb, HbeAg, HbeAb and HbcAb)

Exclusion Criteria:

* antiviral therapy history
* alanine aminotransferase (ALT) \>400 U/L
* serum total bilirubin \> 50 μmol/L
* HBVDNA \> 10\^9copies/mL
* extrahepatic metastasis or main portal vein embolus
* apparent cardiac or pulmonary dysfunction
* liver function: Child B or Child C
* HCV infection

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Liver cancer institute, Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Liver cancer institute, Zhongshan Hospital
name: jinglin xia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05170035: Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery
Official title: Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Cancer
Basal Cell Carcinoma
Keywords: Skin Cancer
Basal Cell Carcinoma
Mohs micrographic surgery
MMS
Autologous patch
Secondary intention healing
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Benzon Foundation
First posted: 2021-12-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled clinical trial
Primary purpose: TREATMENT

Brief summary: The primary objects of this study is to explore the potential effect of the autologous patch to optimize wound healing after skin cancer surgery with Mohs micrographic surgery (MMS) in the face in a randomized controlled trial comparing autologous patch healing versus secondary intention healing.


Eligibility criteria: Inclusion Criteria:

1. Subjects undergoing MMS for biopsy verified primary nodular basal cell carcinoma in the face, head and neck area on a location suitable for secondary intention healing and thus may also be suitable for autologous patch healing
2. Presenting relevant medical record report at study initiation
3. Written informed consent obtained from subject
4. Understanding of investigation procedures and willingness to abide to all procedures during the course of the investigation.

Exclusion Criteria:

1. A subjects with major systemic disease not yet stabilized
2. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
3. Pregnant or breast feeding
4. Unable to follow the outlined study protocol
5. Participation in other studies at the same time that may affect the wound healing.

Primary outcomes:
measure: Blinded assesment of wound healing at day 18-20.
timeFrame: Day 18-20
Secondary outcomes:
measure: Blinded assesment of wound healing at day 11-13
timeFrame: day 11-13
measure: TEWL measurement
timeFrame: day 11-13 and day 18-20
measure: Scar evaluation using the patient-observer-scar-assesment-scale (POSAS) at 6 months follow-up.
timeFrame: 6 months
measure: Difference in microbiology between intervention wounds and control wounds.
timeFrame: day 1 and day 11-13
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
References:
Clinical trial NCT05696535: Investigation of the Relationship Between Lower and Upper Extremity Selective Motor Control and Sensory Functions in Children With Spastic Cerebral Palsy
Official title: Investigation of the Relationship Between Lower and Upper Extremity Selective Motor Control and Sensory Functions in Children With Spastic Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spastic Cerebral Palsy
Motor Activity
Lower Extremity Problem
Upper Extremity Problem
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with spastic cerebral palsy

Brief summary: Although spasticity, contractures and muscle weakness in children with CP are disorders that can be observed more easily and are more focused and given more importance in evaluation and treatment approaches; Inadequate or loss of selective motor control negatively affects motor functions to a greater extent.

It is very important to reveal the causes and consequences of selective motor disability in children with spastic cerebral palsy, in terms of creating effective treatment plans.

The number of patients to participate in the study was determined as 100. The study will be carried out in Hatay Mustafa Kemal University Research and Application Hospital, Department of Pediatrics.

In our study, demographic information will be filled in, and lower extremity selective control assessment scale (SCALE) for lower extremity, upper extremity selective control scale (SCUES) for upper extremity, and sensory assessment (touch, two-point discrimination and proprioceptive sensory assessment) will be performed on the patients who accepted the study.


Eligibility criteria: Inclusion Criteria:

* Giving consent to participate in the study
* To be diagnosed with spastic type cerebral palsy;
* Being between the ages of 4-18;
* Being at level I-II-III according to the gross motor function classification system (GMFCS);
* Not having undergone Botulinum Toxin injection/lower-upper extremity surgery in the last 6 months

Exclusion criteria:

* To be in level IV-V according to gross motor function classification system (GMFCS)
* Having severe mental retardation who does not understand verbal commands

Primary outcomes:
measure: Evaluation of selective motor control function
timeFrame: 2 months
Secondary outcomes:
measure: The relationship between selective motor control and sensory functions
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02007135: Comparison of Pneumatic and Electromagnetic Muscle Vibrators to Stimulate Muscle Proprioceptors
Official title: Comparison of fMRI Compatible Pneumatic and Electromagnetic Muscle Vibrators to Stimulate Muscle Proprioceptors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proprioceptive Postural Control
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2013-12-10
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Young Flemish Volunteers

Brief summary: The purpose of this study is to determine the concurrent validity of a newly developed pneumatic, fMRI compatible muscle vibrator as compared to a electromagnetic muscle vibrator in the stimulation of muscle proprioceptors.


Eligibility criteria: Inclusion criteria for healthy individuals:

* Age: 20-45 years old
* No history of low back pain
* A score of 0% on the Oswestry Disability Index
* Willingness to sign the informed consent

Exclusion Criteria:

* History of major trauma and/or major orthopedic surgery of the spine, pelvis or lower quadrant
* One of the following conditions: Parkinson, MS, Stroke with sequels....
* Radicular symptoms
* Not Dutch-speaking
* Strong opioids
* Neck pain
* Ankle problems
* Smoking

Primary outcomes:
measure: Proprioceptive postural control
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
Study officials:
affiliation: KU Leuven
name: Simon Brumagne, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Claeys K, Brumagne S, Dankaerts W, Kiers H, Janssens L. Decreased variability in postural control strategies in young people with non-specific low back pain is associated with altered proprioceptive reweighting. Eur J Appl Physiol. 2011 Jan;111(1):115-23. doi: 10.1007/s00421-010-1637-x. Epub 2010 Sep 8.
Clinical trial NCT06862635: Efficacy of Hydrotherapy on Balance in Neuropathic Patients Post-Burn
Official title: Efficacy of Hydrotherapy on Balance in Neuropathic Patients Post-Burn
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Neuropathy
Burn
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 50
Sex: MALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Balance problems are common among neuropathic patients following burns, primarily due to sensory and motor impairments.The goal of the study is to investigate the effect of a hydrotherapy program on balance in neuropathic patients following burns. It is a randomized controlled study will be conducted on fifty male patients (age range from 35 to 45 years) with polyneuropathy following lower limb burn injuries, mainly at the sole of the foot, with 3rd-degree injuries and 30% burn extent.

Balance will be assessed before and after treatment using the Biodex Balance System and the Berg Balance Scale (BBS).

Patients will be randomly assigned into two equal groups:

Group A (study group) will receive hydrotherapy sessions including stretching, resistance, and balance exercises in water.

Group B (control group) will receive traditional land-based balance exercises only.


Eligibility criteria: Inclusion Criteria:

* polyneuropathy following burn injuries of the lower limb mainly at the sole of the foot.
* 3rd-degree injuries and 30% burn extent.
* Patients' ages range from 35 to 45 years,
* Ability to understand instructions and following commands.

Exclusion Criteria:

* balance disturbances due to neurological disorders other than polyneuropathy (e.g., Parkinson's disease, inner ear disorders, vestibular or cerebellar dysfunctions).
* Uncontrolled hypertension.
* Diabetes mellitus,
* Cognitive impairments
* Blindness.
* Deafness.
* Significant respiratory or cardiac conditions.

Primary outcomes:
measure: Balance assessment (Biodex Balance System)
timeFrame: Balance will be assessed by bode balance system before the first session and after 12 sessions (3 months)
Secondary outcomes:
measure: Balance assessment (Berg Balance Scale)
timeFrame: Berg balance scale will be recorded before the fisrt session and after 12 sessions (3 months)
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Kasr alainy
Study officials:
References:
Clinical trial NCT04204135: The Course of Hip Flexion Weakness Following LLIF or ALIF
Official title: The Course of Hip Flexion Weakness Following LLIF or ALIF
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Degenerative Disc Disease
Herniated Nucleus Pulposus
Spondylolisthesis
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 22
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing LLIF or ALIF procedures

Brief summary: The purpose of this study is to assess the course of hip weakness after LLIF or ALIF procedures. These outcomes include measures of hip strength using a dynamometer, which is a device used to measure muscle strength. While it is known that people experience temporary hip and leg weakness after an LLIF or ALIF, the exact timing of when hip and leg strength is regained after an LLIF or ALIF is not known.


Eligibility criteria: Inclusion Criteria:

* 1-, 2-, or 3-level L2L3, L3L4, or L4L5 LLIF or ALIF for degenerative pathology including radiculopathy, neurogenic claudication, intervertebral disc disease, facet joint disease, degenerative spondylolisthesis, degenerative myelopathy degenerative kyphosis, and scoliosis
* Back and/or leg pain
* Failed at least 6 months of conservative treatment

Exclusion Criteria:

* Older than 65 years of age
* Prior spinal fusion surgery
* Greater than Grade 2 spondylolisthesis
* Greater than 10° scoliosis
* History of spinal infection

Primary outcomes:
measure: Hip flexion and knee extension strength as measured by the Lafayette Instrument Manual Muscle Testing Device (Dynamometer).
timeFrame: Assessing changes in hip flexion and leg extension strength from the preoperative baseline to postoperative measurements taken at 6 weeks, 12 weeks and 6 months following lumbar fusions.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT02841735: Young Adult Naturalistic Alcohol Study (YANAS) Using Smartphone Technology in a Simulated Laboratory Environment
Official title: Young Adult Naturalistic Alcohol Study (YANAS) Using Smartphone Technology in a Simulated Laboratory Environment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alcohol Use
Alcohol Drinking
Drinking Behavior
Keywords: brief intervention
web-based interventions
harm reduction
young adult
college student
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Interested individuals will contact the study by telephone or by email or will go directly to the study's information page located at www.yanasinfo.org.

Brief summary: It is important to explore use of technology to reduce drinking. The purpose of this research study is to compare different types of mobile technology for their effects on alcohol drinking and ratings of usability among young adults.This study will be conducted in four phases: a web-based screening assessment; brief appointment on the day of the alcohol drinking session; alcohol drinking session; and a follow-up appointment. Participation in this study will last approximately two months.


Eligibility criteria: Inclusion Criteria:

* Be able to read English and complete assessments
* Drink alcohol regularly

Exclusion Criteria:

* Test positive on a urine test for use of certain illegal drugs
* Undergraduate student enrolled in the University of Florida
* Graduate students from the College of Health and Human Performance at the University of Florida
* Pregnant, or breast feeding

Primary outcomes:
measure: Quantity of alcohol consumption
timeFrame: During an alcohol drinking session
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Department of Health Education and Behavior
state: Florida
Study officials:
affiliation: University of Florida
name: Robert F. Leeman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: