louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05120492: Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial
Official title: Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Morbid Obesity
Keywords: Arthroplasty, Replacement, Knee
Bariatric Surgery
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Does weight loss surgery in patients with morbid obesity prior to knee replacement surgery improve outcomes from knee replacement surgery

Detailed description: RCT involving patients who have severe knee osteoarthritis and have a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 45 to 60 and are randomly assigned to receive dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (control arm) or sleeve gastrectomy with dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (treatment arm).

Eligibility criteria: Inclusion Criteria:

severe knee osteoarthritis body-mass index of 45 to 60

Exclusion Criteria:

previous total replacement of the same knee, a need for bilateral total knee replacement, and knee pain during the previous week that the patient rated at higher than 60 mm on a 100-mm visual-analogue scale. Also,prior bariatric or complex foregut surgery, significant cardiovascular, pulmonary, renal, liver, gastrointestinal, psychiatric disorders, pregnancy, malignancy within last 5 years, anemia, coagulopathy requiring anti-coagulation therapy.

Primary outcomes:
measure: Pain, mobility and quality of Life
timeFrame: 1 year
Secondary outcomes:
measure: EuroQol Group 5-Dimension Self Report Questionnaire (EQ-5D)
timeFrame: 1 year
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health
state: Nova Scotia
Study officials:
References:
Clinical trial NCT05225792: Rapid Rehabilitation to Treat Lower Extremity Trauma
Official title: Improved Training Method for Advanced Rehabilitation of Warfighters With Lower Extremity Trauma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Limb Trauma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to find out if an advance balance perturbation training program can enhance the rehabilitation process by increasing weight-bearing strategies on the prosthetic or injured limb, and, help reduce stumbles and falls.


Eligibility criteria: Inclusion Criteria:

* Research participants will be eligible active duty service members and retired veterans.
* Having lower limb trauma (transtibial and transfemoral amputations, bilateral amputations, and limb salvage).
* Are enrolled in conventional rehabilitation at the participating military treatment centers.
* Subjects with dysvascular disease will be excluded because compromised lower limb somatosensation and circulation are independently linked with poor postural stability and a history of frequent falls.
* For subjects with amputations, the individual must be a community ambulator (i.e., K-Level 3 or 4).
* For subjects with limb salvage, they will need to have an IDEO and be entered into the Return-to-Run training program.

Exclusion Criteria:

- Subjects must not have excessive pain or other neuromuscular problems that preclude them from performing the test protocol.

Primary outcomes:
measure: Prosthesis Evaluation Questionnaire-Addendum (PEQ-A)
timeFrame: 0, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kenton Kaufman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00761592: Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blepharospasm
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 65
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 pilot study estimates the treatment effects of two different types of botulinum toxin type A in the treatment of Blepharospasm. Blepharospasm is characterised by excessive contraction of the muscles around the eye and can lead to repetitive blinking or sustained closure of the eyelids.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with benign essential blepharospasm
* Received ≥20U/eye of BOTOX® for at least one visit prior to study entry and required, in the investigators opinion, the same dose at the study injection visit.
* Combined Jankovic Rating Score of \>2

Exclusion Criteria:

* Female subjects who were pregnant, breastfeeding, or who were of childbirth potential and not practicing birth control.
* Profound atrophy of the muscles in the target area(s) of injection.
* Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
* Known significantly impaired renal and/or hepatic function

Primary outcomes:
measure: Change From Baseline to Week 4 in Blepharospasm Disability Index
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Change From Baseline to Week 8 in Blepharospasm Disability Index
timeFrame: Baseline to Week 8
measure: Change From Baseline to Week 4 and Week 8 in Total Jankovic Rating Scale (JRS) (Severity and Frequency Measured on a Scale of 0-4)
timeFrame: Baseline to Week 4 and Week 8
measure: Changes From Baseline to Week 4 and Week 8 in Patient Global Assessment (PGA) Score
timeFrame: Baseline to Week 4 and 8
measure: Duration of Action
timeFrame: Interval between initial injection (Week 0) and final visit (Week 11 through Week 14)
Other outcomes:
Locations:
city: Bonn
country: Germany
city: Wiesbaden
country: Germany
city: Zwickau
country: Germany
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02705092: Immediate Effect of Subliminal Priming With Subliminal Reward Stimuli on Standing Balance in Healthy Young Adults
Official title: Immediate Effect of Subliminal Priming With Subliminal Reward Stimuli on Standing Balance in Healthy Young Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Kibi International University
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study was to examine the immediate effect of subliminal priming with subliminal reward stimuli on standing balance in healthy young adults. The study also compared the outcomes with the immediate effects of subliminal priming with supraliminal reward stimuli.


Eligibility criteria: Inclusion Criteria:

1. Healthy volunteers between 18 and 24 years of age
2. Males and Females

Exclusion Criteria:

1. Physical impairment, hindering performance of daily activities

Primary outcomes:
measure: Change in the dynamic standing balance
timeFrame: Baseline and immediately after the intervention protocol
Secondary outcomes:
measure: Change in the static standing balance
timeFrame: Baseline and immediately after the intervention protocol
Other outcomes:
Locations:
Study officials:
affiliation: Kibi International University
name: Kazuki Hirao, PhD, OT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04541992: Sensors Prediction Study
Official title: Body-Worn Sensors for Risk of Injury Prediction During Military Training
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Injury Leg
Keywords: hip injury
knee injury
ankle injury
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Geneva Foundation
name: Uniformed Services University of the Health Sciences
name: Womack Army Medical Center
First posted: 2020-09-09
Enrollment: 8300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy service member participants stationed at Fort Bragg, North Carolina.

Brief summary: The purpose of this study is to test whether measures of balance and agility can help predict if a Service Member may be at risk for an injury to their legs before beginning their school and training.


Eligibility criteria: Inclusion Criteria:

1. Between the ages of 18-55
2. Active duty Service Members in the 82nd Airborne Division (ABN DIV)
3. Fluent in English speak and reading

Exclusion Criteria:

1. Service members under the age of 18 or over the age of 55 will be excluded
2. Told by a doctor that they should not exercise.
3. Orthopedic injury/surgery of the lower limb or back within the last year and that limits study compliance
4. Regular use of medications that may alter balance, coordination or agility
5. Unwilling to comply with the study protocol

Primary outcomes:
measure: Region of Limb Stability
timeFrame: Day 1
measure: Transitional Angular Displacement of Segments
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Bragg
country: United States
facility: Womack Army Medical Center
state: North Carolina
Study officials:
affiliation: University of Miami
name: Robert Gailey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05899192: Outcome Factors of Pneumonia Patients in Critical Care Unit
Official title: Factors Predicting Outcome of Admitted Pneumonia Patients in Critical Care Unit
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pneumonia Aggravated
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: People with age above 18 years and below 80 years old with manifestations of pneumonia

Brief summary: To determine the risk factor that affect pneumonic patients at the critical care unit regarding the history investigation and clinical data

Detailed description: Pneumonia remains a serious illness with important clinical impact . It is defined as acute respiratory tract infection that affect lower respiratory tract ,it is classified as community acquired pneumonia (CAP), hospital acquired pneumonia (HAP) and ventilator associated pneumonia .

In this work we assess the factors that affect the prognosis of critically ill patients with pneumonia regarding the age ,sex ,smoking, other co morbidity as diabetes mellitus, hypertension , liver diseases , kidney diseases, heart diseases and chest diseases, clinical date and investigation .

Eligibility criteria: Inclusion Criteria:

* 1- Age above 18 yrs.

  2- Critically ill patients admitted to ICU with clinical manifestations of pneumonia in assuit university hospital

Exclusion Criteria:

* 1- Age below 18 yrs. 2- Patients don't have critical illness 3- Patient who refused to contribute in this study

Primary outcomes:
measure: To assess the risk factor that affect pneumonic patients at the critical cre unit and ICU .
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06467292: Speech Motor Learning and Retention (Master Protocol)
Official title: Sensorimotor Basis of Speech Motor Learning and Retention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Speech
Keywords: Speech Motor Learning
Retention
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2024-06-21
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Healthy right-handed adults with normal hearing will be recruited in equal number from both sexes. All participants will be fluent English speakers.
Primary purpose: BASIC_SCIENCE

Brief summary: The overall goal of this research is to test a new model of speech motor learning, whose central hypothesis is that learning and retention are associated with plasticity not only in motor areas of the brain but in auditory and somatosensory regions as well.

Detailed description: Aim 1 involves tests of speech motor memory retention following disruption of left hemisphere brain activity in either auditory, somatosensory or motor cortex or to a control site (hand area motor cortex right hemisphere). Continuous theta-burst stimulation (cTBS) is delivered following adaptation to altered auditory feedback to assess its effects on the retention of new learning.

Aim 2 assesses the temporal order in which plasticity occurs in cortical motor and sensory brain areas during speech motor learning.

In Aim 3, resting-state fMRI will be interleaved with speech motor adaptation. For information specific to each aim, please refer to the below corresponding, separate, clinicaltrials.gov records: unique IDs: 2000037622_a for Aim 1, 2000037622_b for Aim 2 and 2000037622_c for Aim 3.

Eligibility criteria: Inclusion Criteria:

* Fluent English speakers
* Right-handed
* Normal hearing
* No speech disorder or reading disability

Exclusion Criteria:

* Cardiac pacemaker
* Aneurysm clip
* Heart or Vascular clip
* Prosthetic valve
* Metal implants
* Metal in brain, skull, or spinal cord
* Implanted neurostimulator
* Medication infusion device
* Cochlear implant or tinnitus (ringing in ears)
* Personal and/or family history of epilepsy or other neurological disorders or history of head concussion
* Psychoactive medications
* Pregnancy

Primary outcomes:
measure: Speech motor learning
timeFrame: Performance as measured at the end of learning (30 minute session)
measure: Retention of learning
timeFrame: 24 hours after learning (re-test lasts 30 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: David Ostry
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01533792: Effect of Non-surgical Periodontal Treatment
Official title: Effect of Non-surgical Periodontal Treatment on Pregnant Women With Periodontitis: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontal Diseases
Adverse Effects
Keywords: Treatment
pregnant women
periodontitis
dental scaling
dental plaque
Lead sponsor: Universidade Federal do Maranhão
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 43
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: The objective of this research was to compare the effect of a single session supragingival scaling in a group of pregnant women with periodontal disease with a group that received supra and subgingival scaling.

Methods: The investigators included 34 pregnant women between 15 and 43 who had at least 4 teeth with probing depth ≥ 4 mm or clinical attachment loss ≥ 3 mm, with bleeding on probing in the same place. Women were divided into two groups, the group 1 received supra and subgingival scaling associated with oral hygiene orientation (OHO) and the group 2 received only supragingival scaling with OHO too.


Eligibility criteria: Inclusion Criteria:

* Pregnant women between 15 and 43 who had at least 4 teeth with probing depth ≥ 4 mm or clinical attachment loss ≥ 3 mm, with bleeding on probing in the same place.

Exclusion Criteria:

* Patients with systemic disease or who used medications that interfere in the etiological factors of periodontal disease in the last six months, who wore braces and / or prosthetic devices, and women smokers who did not complete treatment.

Primary outcomes:
measure: Effect of non-surgical periodontal treatment in pregnancy with periodontal disease
timeFrame: 30 days
measure: Effect of non-surgical periodontal treatment in pregnancy with periodontitis
timeFrame: Assess periodontal disease at times: initial (when pregnancy arrived) and final (30 days after periodontal therapy).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06159192: Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus
Official title: Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shock Wave and Nitric Oxide
Keywords: Shock Wave
Ntric oxide
Diabetes mellitus
Nerve conduction velocity
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monitor the effect of low intensity extracorporeal shock wave therapy on impaired nitric oxide synthase and microcirculation changes in type 2 diabetes mellitus with peripheral neuropathy
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to monitor the effect of low intensity extracorporeal shock wave therapy on impaired nitric oxide synthase and microcirculation changes in type 2 diabetes mellitus with peripheral neuropathy.

Detailed description: Low-intensity extracorporeal shockwave therapy (Li-ESWT) improved peripheral nerve repair and regeneration. Li-ESWT exerts its biological effects by increasing neuro¬trophic factors, Schwann cell activation, and cellular signaling activation. Li-ESWT could be a novel treatment for nerve injury-induced diabetic neuropathy and other conditions related to nerve in¬jury.

Eligibility criteria: Inclusion Criteria:

* Patients have to be symptomatically stable with type 2 diabetes mellitus complicated with peripheral neuropathy.
* Optimized pharmacological treatment that will be remained unchanged throughout the study.

Exclusion Criteria:

* Implanted cardiac pacemakers.
* Patients with known skin allergies.
* Presence of skin inflammations.
* Peripheral vascular disease.
* Patients with unstable angina pectoris.
* Progressive ventricular dysrhythmia.
* Intermittent claudication.

Primary outcomes:
measure: • Nitric oxide level and electrophysiological investigations of peripheral nerves and muscles was measured pre and post treatment.
timeFrame: six weeks
measure: • Numerical Rating Pain Scale
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Luxor
country: Egypt
facility: South Valley University
state: South Valley University
city: Luxor
country: Egypt
facility: South Valley University
state: South Valley University
Study officials:
References:
citation: Ovayolu N, Akarsu E, Madenci E, Torun S, Ucan O, Yilmaz M. Clinical characteristics of patients with diabetic polyneuropathy: the role of clinical and electromyographic evaluation and the effect of the various types on the quality of life. Int J Clin Pract. 2008 Jul;62(7):1019-25. doi: 10.1111/j.1742-1241.2008.01730.x. Epub 2008 Apr 10.
citation: Cvijanovic M, Ilin M, Slankamenac P, Horvat SB, Jovin Z. The sensitivity of electromyoneurography in the diagnosis of diabetic polyneuropathy. Med Pregl. 2011 Jan-Feb;64(1-2):11-4. doi: 10.2298/mpns1102011c.
Clinical trial NCT00613392: Antioxidant Supplementation in Trauma Patients
Official title: Antioxidant Supplementation in Trauma Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Multiple Trauma
Keywords: antioxidant
oxidant stress
trauma
free radical
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Administration of antioxidants to trauma patients will improve measures of oxidant stress in the blood


Eligibility criteria: Inclusion Criteria:

* Adult non pregnant non lactating trauma patient

Exclusion Criteria:

* GCS \<6
* Renal dysfunction (cre \> 2.5 mg/dl)
* Hepatic dysfunction ( TBili \> 3.0 mg/dl)
* Expected survival \< 48 hours
* Burns over \> 20% body surface area
* Immune-deficiency syndromes
* Steroid use

Primary outcomes:
measure: measures of malondialdehyde level/total antioxidant status and F2 isoprostane
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Boston Medical Center
name: Peter Burke, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02432092: Pediatric Cardiomyopathy Mutation Analysis
Official title: Pediatric Cardiomyopathy Mutation Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiomyopathies
Dilated Cardiomyopathy
Hypertrophic Cardiomyopathy
Restrictive Cardiomyopathy
Arrhythmogenic Right Ventricular Cardiomyopathy
Left Ventricular Non-compaction Cardiomyopathy
Keywords: Cardiomegaly
Cardiovascular Diseases
Heart Diseases
Systolic dysfunction
Diastolic dysfunction
Ventricular hypertrophy
Heart failure
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2015-05-01
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Families affected by cardiomyopathy

Brief summary: The goal of this protocol is to obtain information from individuals with cardiomyopathy and from their families in order to elucidate the molecular genetics of this disorder. This will provide the basis for future genetic counseling as well as contribute to elucidating the biology of normal and abnormal cardiac function.

Detailed description: Cardiomyopathy is a genetically heterogeneous heart muscle disorder that results in ventricular dysfunction. While significant progress has been made in identifying the genetic basis of cardiomyopathy in adults, molecular diagnosis in children has proven more challenging and current algorithms do not incorporate mutation analysis in the clinical protocol. However, recent studies indicate that cardiomyopathy outcomes in children are origin specific, highlighting the importance of precise diagnosis. The goal of this study is to identify the genetic causes of pediatric cardiomyopathy. Rapid, comprehensive and cost-effective detection of genetic causes of cardiomyopathy will aid management and development of novel treatment strategies.

Eligibility criteria: Inclusion Criteria:

* Subjects with cardiomyopathy
* Family members of subjects with cardiomyopathy

Exclusion Criteria:

* Subjects without cardiomyopathy
* Family members of subjects without cardiomyopathy

Primary outcomes:
measure: Elucidate the molecular genetics of cardiomyopathy
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU School of Medicine
state: Indiana
Study officials:
affiliation: IU School of Medicine
name: Stephanie Ware, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: