louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03819738: fMRI in Deep Brain Stimulation
Official title: Functional Magnetic Resonance Imaging in Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Chronic Pain
Keywords: fMRI
epilepsy
pain
electrode
brain
neuromodulation
DBS
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: For each subject, condition effects will be estimated using the general linear model
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: With fMRI, we want to understand the mechanisms of brain neuromodulation in (dys)functional brain circuits, to obtain knowledge on involved brain networks in DBS.

Detailed description: Deep brain stimulation represents a neurosurgical treatment option for specific refractory neurological and psychiatric disorders. In these patients a specific brain target is stimulated through an electrode with the use of an implantable pulse generator (IPG). In a functional MRI (fMRI) experiment, the investigators intend to perform imaging during stimulation ON and compare brain activations with the stimulation OFF condition. In this way, they aim to elucidate the involved brain network in deep brain stimulation. Since the connectivity of deep brain structures is complex, different activation patterns are expected in-between subjects and conditions. If specific activation patterns during the stimulation ON condition can be related to treatment response, this is of important clinical value. These findings can lead to an optimization of the deep brain target or even to different useful targets for brain stimulation.

Eligibility criteria: Inclusion Criteria:

* Deep brain stimulation system implanted

Exclusion Criteria:

* Children and pregnant women will be excluded. Failure to follow to protocol is also an exclusion criterion.

Primary outcomes:
measure: Determine the functional networks that are involved in DBS
timeFrame: 5 years
measure: To link the involved network to outcome in DBS therapy
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Tom Theys, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06109038: Effects of ITB Myofascial Release on Symptoms Associated With Knee OA.
Official title: Effects of ITB Myofascial Release on Symptoms Associated With Knee OA.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee OA
ITB tightness
Graston technique
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trial is to determine the effects of ITB myofascial release with graston technique on symptoms associated with knee Osteoarthritis for reducing pain, enhancing knee range of motion and decrease functional disability.

Detailed description: Graston technique, Instrument assisted soft tissue mobilization (IASTM) also known as myofascial release technique is a skilled myofascial intervention used for soft-tissue treatment. Graston is a myofascial release tool that decreases adhesions, trigger points and tension in muscles. Graston Technique on Iliotibial Band Syndrome resulted in a decrease in subjective symptoms and an improvement in muscle function.

Eligibility criteria: Inclusion Criteria:

* knee OA Grade 2 and Grade 3 according to kellgren and Lawrence grading scale
* Positive Ober's test

Exclusion Criteria:

* Patient with cardiovascular or medical illness.
* Patient with any severe trauma or surgery of knee.
* Knee deformity
* Low back pain with or without radiculopathy.
* Neurological illness
* Participants having any wound or scar on the site of treatment.
* Pregnant female
* Participants having co-morbidities such as neoplasm etc.

Primary outcomes:
measure: WOMAC questionnaire
timeFrame: 4 WEEKS
measure: Numeric Pain Rating Scale
timeFrame: 4 WEEKS
measure: Goniometer
timeFrame: 4 WEEKS
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Maria khalid, MS-OMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006438: How Shoes With Rocker Soles Affect Walking
Official title: Rocker Sole Kinetics and Kinematics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Feet
Keywords: Rocker sole
Plantar pressure
Diabetic feet
Insensate feet
gait analysis
Pedorthics
Gait abnormalities
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2000-11-06
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare how 3 special types of shoes with rocker-shaped soles help people with foot deformities to walk better. This study will use modern gait lab techniques to measure the forces on the bottom of the feet and to examine whether there is any effect higher on the leg from the rocker soles.

Detailed description: The rocker sole is the most commonly prescribed external shoe modification. Use of rocker soles has been based on theoretical considerations and empirical observations with minimal scientific study and validation. With the passage of the therapeutic shoe bill (PL-100-203, section 4072) authorizing Medicare coverage of shoes and shoe modifications for diabetics, it is important to have objective data regarding the effect of rocker soles. This cross-over study will randomize 46 subjects (40 sensate and 6 insensate) to a combination of 3 rocker soles. Patients will be evaluated at baseline and after 20 minutes wearing each rocker sole shoe design to determine the effect of the type of rocker sole on plantar pressure and gait.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals
* Insensate individuals

Exclusion Criteria:

* History or physical findings of any trunk, back or lower extremity orthopedic or neurologic abnormalities
* Inability to walk
* Inability to follow verbal directions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Gait Lab
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Jacqueline Wertsch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04944238: A-constant Optimization of a Toric Monofocal IOL
Official title: Optimization of the Optical Constants of the PhysIOL ANKORIS Intraocular Lens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-29
Enrollment: 78
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pseudophakic patients implanted with one of the two IOLs

Brief summary: The study is a prospective series study to determine the IOL constant of a hydrophilic toric monofocal intra-ocular lens (IOL)

Detailed description: The study is a prospective series study with he principal objective to determine the IOL constant.

The secondary objectives of this study are to determine the rotational stability of the Ankoris intraocular lens and to measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.

Although there may be no direct benefit to the subjects under study, the investigation will determined the optimized constant for accurate IOL power calculation and will assess the stability and efficacy of the toric optics: this would result in a benefit for the patient population. Since the material, the overall design of the IOL as well as the measuring procedure in this study is well tolerated in standard clinical practice and the IOL is readily available and CE-marked, the benefit/risk ratio appears acceptable.

Eligibility criteria: Inclusion Criteria:

* Patient older than 50 years old
* Age-related cataract
* Corneal astigmatisme \>1 D
* Age 21 and older
* Visual Acuity \> 0.05
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.

Exclusion Criteria:

* Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies
* Previous ocular surgery or trauma.

Primary outcomes:
measure: The principal objective of the study is to determine the IOL constant.
timeFrame: 1-2 hours
measure: The principal objective of the study is to determine the IOL constant.
timeFrame: 1 month
measure: The principal objective of the study is to determine the IOL constant.
timeFrame: 3 months
Secondary outcomes:
measure: Rotational stability
timeFrame: 1-2 hours
measure: Rotational stability
timeFrame: 1 month
measure: Rotational stability
timeFrame: 3 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Guy Sallet
Study officials:
affiliation: Private Eye Institue Aalst, Belgium
name: Guy Sallet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02492438: 13 Valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients
Official title: Immunogenicity and Safety of the 13-valent Pneumococcal Conjugate Vaccine in Chronic Dialysis Patients That Are 23-valent Pneumococcal Polysaccharide Vaccine Naive and Pre-immunized.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Failure
Keywords: pneumococcal vaccination
dialysis
immune response
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2015-07-08
Enrollment: 154
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the immunogenicity of the PCV13 (13 valent pneumococcal conjugated vaccine) vaccine as compared to the PPV23 (23 valent pneumococcal polysaccharide vaccine) vaccine in patients treated with chronic hemodialysis that are pre-immunized with the PPSV23 vaccine or are PPV23 vaccine naïve by measuring the ELISA and OPA (opsonophagocytic assay) titers after 4 and 52 weeks.

Detailed description: The immunogenicity of the PCV13 (13 valent pneumococcal conjugated vaccine) vaccine as compared to the PPV23 (23 valent pneumococcal polysaccharide vaccine) vaccine in patients treated with chronic hemodialysis that are pre-immunized with the PPV23 vaccine or are PPV23 vaccine naïve will be measured by ELISA and OPA (opsonophagocytic assay) titers after 4 and 52 weeks.

Eligibility criteria: Inclusion Criteria:

1. they are under chronic dialysis treatment
2. are 50 years or older and not pregnant
3. have no immediate life threatening conditions
4. are not allergic to one of the compounds of the vaccine
5. have a known pneumococcal vaccination status
6. give their informed consent.

Exclusion Criteria:

Patients not fulfilling the inclusion criteria.

Primary outcomes:
measure: Antibody response after vaccination to involved serotypes measured by OPA and ELISA
timeFrame: 52 weeks after vaccination
Secondary outcomes:
measure: record of side effects of vaccination
timeFrame: first week after vaccination
measure: Antibody response after vaccination to involved serotypes measured by OPA and ELISA
timeFrame: 4 weeks after vaccination
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Dienst Nefrologie, OLV Ziekenhuis
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge Oostende AV
Study officials:
affiliation: Department of Nephrology and Infectious Diseases, AZ Sint-Jan Brugge, Belgium
name: Stefaan J Vandecasteele, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02040038: Diabetes Self-Management & Support LIVE
Official title: Diabetes Self-Management & Support LIVE (Learning in Virtual Environments)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Virtual Environment
Self-Management
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-01-20
Enrollment: 212
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether participation in virtual environment which incorporates real-time diabetes self management and support (DSMT/S) is associated with positive changes in behavior and metabolic outcomes as compared to traditional web-based DSMT/S.


Eligibility criteria: Inclusion Criteria:

* Live in close proximity to Duke University Medical Center (DUMC) or NYU Endocrinology Clinic, or Faculty Practice and Bellevue Medical Center to facilitate follow-up research appointments
* Diagnosis of Type 2 Diabetes (T2D)
* \>= 21 years old
* able to read and understand English
* access to a computer with broad band internet connection in a private location
* reachable by telephone
* no pre-existing medical condition(s) or severe diabetes related complications that would interfere with study participation (e.g.
* Are able to travel to a clinical lab for blood work

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Dietary Intake
timeFrame: 18 months
measure: Change in Physical Activity
timeFrame: 18 months
Secondary outcomes:
measure: Change in HbA1C level
timeFrame: 18 months
measure: Change in BMI
timeFrame: 18 months
measure: Change in Waist Circumference
timeFrame: 18 months
measure: Change in Blood Pressure
timeFrame: 18 months
measure: Change in Lipid Levels
timeFrame: 18 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Constance M. Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University School of Nursing
name: Allison Vorderstrasse, DNSc
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University
name: Gail Melkus, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson CM, McIlwain S, Gray O, Willson B, Vorderstrasse A. Creating a sustainable collaborative consumer health application for chronic disease self-management. J Biomed Inform. 2017 Jul;71:198-206. doi: 10.1016/j.jbi.2017.06.004. Epub 2017 Jun 6.
citation: Vorderstrasse AA, Melkus GD, Pan W, Lewinski AA, Johnson CM. Diabetes Learning in Virtual Environments: Testing the Efficacy of Self-Management Training and Support in Virtual Environments (Randomized Controlled Trial Protocol). Nurs Res. 2015 Nov-Dec;64(6):485-93. doi: 10.1097/NNR.0000000000000128.
Clinical trial NCT04026438: Randomized Controlled Trial to Study the Outcome of Intravenous Phosphate Supplementation in Live Donors Undergoing Hepatectomy for Living Donor Liver Transplantation (LDLT)
Official title: Randomized Controlled Trial to Study the Outcome of Intravenous Phosphate Supplementation in Live Donors Undergoing Hepatectomy for Living Donor Liver Transplantation (LDLT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Complication, Postoperative
Regeneration Liver
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, we aim to analyse the effect of phosphate supplementation on donors undergoing partial hepatectomy for LDLT. In Group A, we are going to supplement phosphate in donors postoperatively from day 1 to day 5. We will analyse the trend of serum phosphate levels in donors postoperatively, its correlation with occurrence of postoperative complications and status of liver regeneration by CT volumetry on Day 7. Group B will constitute the controls for the study and hence attempt to find out the effect of phosphate supplementation in all donors postoperatively. We will analyse the data and elucidate the value of phosphate supplementation in reducing the occurrence of complications and effect on liver regeneration in donors in LDLT.


Eligibility criteria: Inclusion Criteria:

* All donors evaluated as per institutional protocol for donor hepatectomy and found fit
* Those who consent.

Exclusion Criteria:

* Patients refusing to consent for inclusion in the study.
* Minor hepatectomy
* Those who develop profound hypophosphatemia in the control group

Primary outcomes:
measure: Post operative complications
timeFrame: 1 month
Secondary outcomes:
measure: Trend of serum phosphorous levels
timeFrame: 1 week
measure: Trends in post-operative liver function tests
timeFrame: 1 week
measure: Duration of hospital, ICU stay
timeFrame: Till patient is discharged on an average of 10 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
Study officials:
affiliation: Professor and Head, Department of HPB surgery and Liver transplantation, ILBS, New Delhi.
name: Viniyendra Pamecha, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00634738: The Treatment of the Median Nerve for the Elimination of the Symptoms Associated With the Carpal Tunnel Syndrome
Official title: Neuropathy Along the Median Nerve: Etiology of Symptoms Associated With the Carpal Tunnel Syndrome, a Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Compression Neuropathy, Carpal Tunnel
Keywords: ischemic compression;carpal tunnel syndrome
Lead sponsor: Guy Hains Chiropractor
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In carpal tunnel syndrome,trigger points are often found in the biceps muscle,in the aponeurosis of the biceps and in the pronator teres muscle.

We hypothesise that by eliminating these trigger points,using ischemic compressions, may diminish the symptoms.

Detailed description: Using one thumb on the other,the pressure is applied 10 seconds on each TrPs.The treatment is done on each visit for a total of 15(without Charge).

Eligibility criteria: Inclusion Criteria:

* Between 20 and 60 years old,
* Numbness in the hand affecting the thumb, the index finger, the middle finger and half the ring finger,
* To have suffered from discomfort on a daily basis for at least three months and to agree to a course of 15 chiropractic treatments at no cost.

Exclusion Criteria:

* History of upper limb or neck surgery,
* Pregnancy and systemic pathologies possibly related to CTS, such as hypothyroidism, diabetes and rheumatoid arthritis.

Primary outcomes:
measure: Levine DW Questionnaire (J.Bone Joint Surg Am 1993;75:1585-92)on carpal tunnel syndrome
timeFrame: after 15treatments,30 days after,6 months later
Secondary outcomes:
measure: A numerical scale,filled by the patient,where they give their perceived improvement from 0% to 100%.
timeFrame: After 15 treatments, 30 days later and 6 months later.
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: Guy Hains 2930 Côte RIchelieu
state: Quebec
Study officials:
affiliation: UQTR
name: Martin Descarreaux, DC PHD
role: STUDY_CHAIR
References:
Clinical trial NCT05050838: Prone Positioning for Brain-injured Patients With Severe ARDS (ProBrain)
Official title: Prone Positioning for Brain-injured Patients With Severe ARDS (ProBrain)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Blood Flow
Keywords: Prone Position
Acute Respiratory Distress Syndrome
Intracranial Pressure
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-09-21
Enrollment: 11
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - Brain-injured patients with ARDS requirering prone positioning

Brief summary: Prone position (PP) is a key component to treat hypoxemia in patients with severe acute respiratory distress syndrome (ARDS). However, most studies evaluating PP effects in patients with ARDS exclude those with brain-injuries without providing any medical evidence. This prospectice observational study aimed to investigate if prone positioning leads to significant modification of cerebral perfusion in brain-injured patients with ARDS.


Eligibility criteria: Inclusion Criteria:

* adult's patients suffering from brain injuries
* patients neurologically monitored with TCD
* patients requiring prone position for severe ARDS

Exclusion Criteria:

* pregnant women
* patients with contrindication to prone position

Primary outcomes:
measure: Cerebral Blood Flow
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
state: Ile-de-France
Study officials:
References: