louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02857335: Neurocognitive Outcome in Children Who Suffered From Idiopathic Increased Intracranial Hypertension (IIH)
Official title: Neurocognitive Outcome in Children Who Suffered From Idiopathic Increased Intracranial Hypertension (IIH)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prospective Study , Questionaires
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-08-05
Enrollment: 15
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 15 patients, Ages 8-17 who were diagnosed in the recent years with Idiopathic increased intracarnial hypertension (IIH) went through a battery of neurocognitive tests to establish whether there was any affect of the disease on their cognitive function


Eligibility criteria: Inclusion Criteria:

* children who suffered from IIH based on history, physical examination, ophtalmological exam, LP results, Brain imagining

Exclusion Criteria:

* co morbidities

Primary outcomes:
measure: neurocognitive outcomes
timeFrame: once
Secondary outcomes:
measure: Non-Verbal Memory
timeFrame: once
measure: Go-No Go Test
timeFrame: once
measure: Stroop Interference
timeFrame: once
measure: Visual Spatial Processing
timeFrame: once
measure: Staged Information Processing Speed
timeFrame: once
measure: cognitive domains
timeFrame: once
measure: Problem Solving
timeFrame: once
Other outcomes:
Locations:
Study officials:
References:
citation: D'Amico D, Curone M, Erbetta A, Farago' G, Bianchi-Marzoli S, Ciasca P, Bussone G, Chiapparini L. Intracranial idiopathic hypertension: 1-year follow-up study. Neurol Sci. 2014 May;35 Suppl 1:177-9. doi: 10.1007/s10072-014-1765-x.
citation: Wall M. Idiopathic intracranial hypertension. Neurol Clin. 2010 Aug;28(3):593-617. doi: 10.1016/j.ncl.2010.03.003.
citation: Dave SB, Subramanian PS. Pseudotumor cerebri: an update on treatment options. Indian J Ophthalmol. 2014 Oct;62(10):996-8. doi: 10.4103/0301-4738.145991.
citation: Afonso CL, Talans A, Monteiro ML. Factors affecting visual loss and visual recovery in patients with pseudotumor cerebri syndrome. Arq Bras Oftalmol. 2015 May-Jun;78(3):175-9. doi: 10.5935/0004-2749.20150045.
citation: Zur D, Naftaliev E, Kesler A. Evidence of multidomain mild cognitive impairment in idiopathic intracranial hypertension. J Neuroophthalmol. 2015 Mar;35(1):26-30. doi: 10.1097/WNO.0000000000000199.
citation: Kharkar S, Hernandez R, Batra S, Metellus P, Hillis A, Williams MA, Rigamonti D. Cognitive impairment in patients with Pseudotumor Cerebri Syndrome. Behav Neurol. 2011;24(2):143-8. doi: 10.3233/BEN-2011-0325.
citation: Soiberman U, Stolovitch C, Balcer LJ, Regenbogen M, Constantini S, Kesler A. Idiopathic intracranial hypertension in children: visual outcome and risk of recurrence. Childs Nerv Syst. 2011 Nov;27(11):1913-8. doi: 10.1007/s00381-011-1470-5. Epub 2011 May 3.
Clinical trial NCT04243135: r-ESWT in Moderate Knee Osteoarthritis
Official title: Effects of Radial Extracorporeal Shock Wave Therapy (r-ESWT) on Clinical Variables and Isokinetic Performance in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder
Keywords: r-ESWT
knee osteoarthritis
pain
function
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 110
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the efficacy of r-ESWT treatment with sham-ESWT on pain, walking speed, physical function, and isokinetic muscle strength in knee osteoarthritis.

Detailed description: Extracorporeal shock wave therapy (ESWT) has been increasingly used to help relieve pain and to remedy musculoskeletal disorders in recent years. ESWT seems to be an effective treatment modality many different musculoskeletal conditions, including rotator cuff tendinopathies, calcifying tendinopathy of the shoulder, lateral epicondylitis, greater trochanteric pain syndrome, patellar tendinopathy, achilles tendinopathy, plantar fasciitis, and bone disorders. ESWT seems to have chondroprotective, anti-inflammatory, neovascularization, anti-apoptotic, and tissue regeneration effect on tissues which could be relevant in the treatment of OA.

Eligibility criteria: Inclusion Criteria:

* Knee OA according to American College of Rheumatology (ACR) diagnostic criteria with Kellgren - Lawrence (K-L) grade 2 or 3.

Exclusion Criteria:

* Patients with secondary OA,
* severe chronic illness,
* poor general health status (heart failure, chronic bronchitis, etc.),
* chronic inflammatory diseases,
* knee replacement surgery,
* prior malignancy

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: up to 12 weeks
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: up to 12 weeks
measure: 20-meter walk test
timeFrame: up to 12 weeks
measure: isokinetic muscle performance
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Mustafa Kemal University
Study officials:
affiliation: Mustafa Kemal University Medical School
name: Alper Uysal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uysal A, Yildizgoren MT, Guler H, Turhanoglu AD. Effects of radial extracorporeal shock wave therapy on clinical variables and isokinetic performance in patients with knee osteoarthritis: a prospective, randomized, single-blind and controlled trial. Int Orthop. 2020 Jul;44(7):1311-1319. doi: 10.1007/s00264-020-04541-w. Epub 2020 Mar 26.
Clinical trial NCT02609035: Immunization Services Model for Adult Rate Improvement
Official title: Immunization Services Model for Adult Rate Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacy
Immunization
Vaccines
Lead sponsor: Pharmacy Quality Alliance
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 22301
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: ImmuSMART is a study of personalized telephonic prompts to community pharmacy patients to improve adult vaccination rates for pneumococcal and herpes zoster vaccines.

Detailed description: This study will investigate immunization rate improvement among adult patients in 250 northeastern US community pharmacies as a result of telephonic prompts during regular automated outbound communiqués. There will be three projects assessing different forms of these appended prompts-appointment-based medication synchronization automated prompts, refill ready automated prompts, and refill reminder automated prompts. Each intervention will occur in one of three pharmacy chains, each with approximately 10,000 patients randomized to control or intervention (receive prompt or no).

Prior to the outbound automated call to the patient, a third-party technology vendor (Scientific Technologies Corporation) will perform an automated immunization status assessment of the patient by submitting a query the state immunization registry to compare the adult patient's existing immunization record to the CDC Recommended Adult Immunization Schedule. Gaps in immunizations that fall within pharmacy scope of practice will be identified. During the automated call (performed by VoicePort, a pharmacy telephonic support vendor) to the patient, they will be prompted to receive identified immunization gap vaccines upon their next pharmacy visit, with priority on pneumococcal, influenza, and herpes zoster vaccinations. If the patient accepts, the vaccination will be delivered when next the patient comes to visit the pharmacy.

After 6 months of running the trial, statistical modeling will be employed to assess vaccination rate differences between control and intervention patients.

Eligibility criteria: Inclusion Criteria:

* Patient at least 19 years of age at date of enrollment
* Patient not in long-term care, hospice or otherwise identified as unable to come to pharmacy for receipt of vaccine
* Patient currently missing a record of receipt of at least one of three vaccinations: flu, pneumonia, or shingles
* Patient enrolled in telephonic pharmacy reminder service

Primary outcomes:
measure: Vaccination rates
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02719535: Corneal Biomechanics and Corneal Reshaping Therapy
Official title: Corneal Stiffness and Tangent Modulus to Predict the Rate of Corneal Curvature Change in Corneal Reshaping Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: corneal reshaping therapy
corneal biomechanics
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the proposed study is to investigate the predictive value of corneal biomechanical properties in corneal reshaping therapy and the role of these parameters in determining the amount of myopia reduction.

Detailed description: Experiment 1: To evaluate changes in corneal biomechanics caused by short-term corneal reshaping therapy.

Subjects will wear a conventional RGP lens in one eye, randomly selected, and an orthokeratology lens in the fellow eye, for 30 minutes, 60 minutes and one night, respectively. Corneal stiffness and tangent modulus will be measured before and after each wearing period.

Experiment 2: To evaluate changes in and the recovery of corneal biomechanics effected by long-term corneal reshaping and to assess whether corneal biomechanics can predict the rate of corneal reshaping.

Subjects will wear orthokeratology lenses for 6 months. Regular follow up visits (1 week, 1 month, 3 months and 6 months) will be arranged to monitor the changes in corneal stiffness and tangent modulus.

Eligibility criteria: Inclusion Criteria:

* Myopia between -4D to -5D, with-the-rule astigmatism not more than 1.5D, spherical equivalent between -4D to -5.75D, difference between two eyes within 1D, best corrected spectacle visual acuity 0.10 logMAR in each eye

Exclusion Criteria:

* previous corneal reshaping therapy, long-term contact lens wear, ocular disease

Primary outcomes:
measure: Change of Corneal Stiffness From Baseline at 6 Months
timeFrame: At baseline, then change from baseline to 6 months
Secondary outcomes:
measure: Change of Tangent Modulus From Baseline at 6 Months
timeFrame: At baseline, then change from baseline to 6 months
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Andrew KC Lam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03985735: Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Video-assisted Thoracic Surgery
Official title: Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Video-assisted Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups (good or poor sleepers) depending on their first postoperative night Bispectral index data.

Brief summary: The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups (good or poor sleepers) depending on their first postoperative night Bispectral index data. Firstly, this study aims to characterise the gut and lung microbiota in patients with lung cancer treated with surgery. Secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.

Detailed description: The study is a case-controlled observational trial. Sixty patients will be divided into 2 groups (good or poor sleepers) depending on their first postoperative night Bispectral index data. Firstly, this study aims to characterise the gut and lung microbiota in patients with lung cancer treated with surgery. Secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.

Eligibility criteria: Inclusion Criteria:

* 1. ethnic Chinese;
* 2. age, 18 to 75 years old;
* 3. American Society of Anaesthesiologists (ASA) physical status I or II;
* 4. required VATS for lung surgery and one lung ventilation .

Exclusion Criteria:

* Cognitive difficulties
* Partial or complete gastrectomy
* Previous esophageal surgery
* Previous treated by radiotherapy or surgery
* Inability to conform to the study's requirements
* body mass index exceeding 30 kg/m2
* Deprivation of a right to decide by an administrative or juridical entity
* Ongoing participation or participation in another study \<1 month ago
* preoperative Pittsburgh Sleep Quality Index global scores higher than 6
* recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine

Primary outcomes:
measure: lung and gut microbiota
timeFrame: from baseline to postoperative 72 hours
Secondary outcomes:
measure: Bispectral index data
timeFrame: the first postoperative night
measure: plasma kynurenine concentrations
timeFrame: baseline and the first postoperative night
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT02898935: Improvement of the Accuracy of Spatial Representation of Invasive Exploratory Electrodes in Focal Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focal Epilepsy
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with drug resistant focal epilepsy, potential candidates for surgery, scheduled for deep brain electrodes exploration.

Brief summary: Reconstruction software allows visualization of cortical structure in 3 dimensions, showing on a single picture the position of all the electrodes. The EEG signal of each recording plot of the electrode is analyzed and compared with the underlying brain structure reconstructed by the software. It is therefore possible to visualize 1) ictogenic and epileptogenic areas using neurophysiological stereoelectroencephalography (SEEG) data and 2) adjacent functional cortical areas with functional imaging and SEEG. Software makes it possible to determine the links between these areas. This study aims to show that using these software is an asset in surgical decision and in the choice of surgical strategy.

Each patient has presurgical evaluation (usual care), including morphologic and (if necessary) functional MRI, EEG and SEEG. In this study, software will be used to analyze the processed data (FSL software, FMRIB laboratory, Oxford University and BrainVisa/Anatomist. The surgical decision will be taken according to the usual staff procedures, based on the usual examination results. After the decision making process, the staff will be asked to reconsider the surgical decision, according to the analysis provided by the software. The discrepancies between the decisions will be recorded.


Eligibility criteria: Inclusion Criteria:

* children aged 18 months to 17 years old
* drug resistant focal epilepsy
* scheduled for deep brain electrodes exploration to assess surgical indication

Exclusion Criteria:

* contraindication to anesthesia or surgery
* refusal (of parents or child) to participate in the study
* no health insurance coverage

Primary outcomes:
measure: number of patients for whom surgical strategy would change if using the software
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Mathilde CHIPAUX, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00742235: hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects
Official title: hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Vitamin D Deficiency
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-08-27
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitamin D deficiency (low levels of vitamin D in the blood) is a common problem. A recently discovered protein, called hCAP18, likely plays an important role in the immune system and may depend on adequate levels of vitamin D. It is not known what levels of vitamin D are needed to allow the body to make this protein. Nor is it known if giving vitamin D to people who are found to be deficient will help boost levels of hCAP18. This study aims to clarify the relationship between vitamin D levels and hCAP18.


Eligibility criteria: Inclusion Criteria:

* Age 18-80

Exclusion Criteria:

* Known active infectious disease or chronic inflammatory disorder
* Hypercalcemia
* Chronic kidney disease
* Pregnancy

Primary outcomes:
measure: hCAP18 Levels
timeFrame: Baseline
measure: Baseline 25-OH Vitamin D Level
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ishir Bhan, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02558335: CTCs for High Grade Glioma
Official title: Circulating Tumor Markers for High Grade Glioma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stage III and IV Glioma Patients
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Patients with grade III and IV glioma

Brief summary: The purpose of this study is to identify and quantify circulating tumor markers, which are associated with the presence of tumors. The current imaging available does not allow specificity of tumor size as it relates to pseudoprogression (a temporary enlargement or "swelling" of the tumor after treatment before it shrinks). Our hope is that CTCs will provide a more accurate description of tumor state for high grade glioma patients.


Eligibility criteria: Inclusion Criteria:

* Patients with biopsy-proven high grade glioma who are undergoing definitive radiotherapy as a part of their treatment regimen or patients with radiographic appearance of high grade glioma
* Age 18 or older
* Signed informed consent

Exclusion Criteria:

Primary outcomes:
measure: to identify and quantify circulating tumor markers
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramsvaniaon Cancer Center of the University of Pennsyl
name: Robert Lustig, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05232435: Pilate Mat Exercise Versus Muscle Energy Technique on Chronic Non Specific Low Back Pain
Official title: Pilate Mat Exercise Versus Muscle Energy Technique on Chronic Non Specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Non Specific Low Back Pain
Keywords: LBP
Pilate mat exercise
MET
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial has 3 groups
Primary purpose: TREATMENT

Brief summary: to investigate the effect of pilat mat exercise versus MET on chronic non specific LBP:Randomized controlled trial

Detailed description: Low back pain (LBP) affects almost everyone at least once per life. Hence,it has been considered one of the most common musculoskeletal problems.The Pilates Method starts by strengthening the core, which is achieved by coordinating breathing with movement. Muscle energy technique is an associate degree of osteopathic manipulation methodology. The muscles of patients were used, on request, to type a singular controlled position, in a very specific direction, and against a distinctly executed therapist-applied counterforce.pilate mat exercise and muscle energy technique play a major role in treatment of patients with chronic non specific LBP so this trial will be conducted to investigate the effect of pilat mat exercise versus MET on chronic non specific LBP:

Eligibility criteria: Inclusion Criteria:

* Seventyeight Subjects will be selected from both genders, with age above 18 years.
* Normal body mass index (BMI) will be included.
* Participants diagnosed with chronic nonspecific LBP.

Exclusion Criteria:

* The participants will be excluded if they had one of the following criteria:
* Patient with previous back surgery, lumbar disc herniation, spinal deformities.
* Neuromusculoskeletal problems as hip arthrodesis or arthroplasty and spondylolisthesis.
* History of Cardiovascular disease, diabetes mellitus and rheumatoid arthritis
* Pregnant women and Osteoprosis.
* Leg length discrepancy.

Primary outcomes:
measure: pain intensity
timeFrame: up to 4 weeks for each group
measure: functional disability
timeFrame: up to 4 weeks for each group
measure: ROM
timeFrame: up to 4 weeks for each group
measure: flexibility
timeFrame: upto 4 weeks for each group
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: faculty of physical therapy
name: hager hekal, PHD student
role: STUDY_CHAIR
References: