louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03475381: Real-life Follow-up of Cystic Fibrosis Patients Treated With Ivacaftor+Lumacaftor (Orkambi*)
Official title: Real-life Follow-up of Cystic Fibrosis Patients Treated With Ivacaftor+Lumacaftor (Orkambi*)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
ivacaftor
lumacaftor
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Effi-Stat
name: Societe Francaise de la Mucoviscidose
First posted: 2018-03-23
Enrollment: 852
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Cystic Fibrosis with presence of two mutations DF508 in the CFTR gene and treated by Orkambi in usual care

Brief summary: The purpose of the study is to examine the real-life safety and effectiveness of the novel combination ivacaftor+lumacaftor in eligible patients with cystic fibrosis (CF). All patients with CF were eligible if they were 12 years and older, started ivacaftor+lumacaftor outside of a clinical trial between December 15th 2017 and December 15th 2018 in an accredited CF center in France. Patient followed-up is based on standardized recommendation of the French Cystic Fibrosis Society. Each patient is followed 1 year.

Detailed description: Each patient is followed one year with visits at months 1, 3, 6 and 12.

At each visit, the following data are recorded:

* Treatment discontinuation or not. If the treatment was discontinued, reasons for discontinuation
* Adverse effects
* Lung function (spirometry)
* Body mass index
* Pulmonary exacerbations (intravenous antibiotics)
* Sputum microbiology
* Liver enzymes are measured at each visit

At the initial and 12 visits, a yearly CF examination is proposed to the patients:

* Blood tests
* Chest CT scans
* Body plethysmography

Eligibility criteria: Inclusion Criteria:

* Patient aged 12 years or older.
* Patient with Cystic Fibrosis with presence of two mutations DF508 in the CFTR gene
* Patient treated with ivacaftor+lumacaftor (Orkambi)

Exclusion Criteria:

* Refusal to participate in the study
* Start of Orkambi as part of a clinical trial

Primary outcomes:
measure: Rates of treatment discontinuation
timeFrame: 1 year
measure: Timing of treatment discontinuation
timeFrame: 1 year
measure: Causes of treatment discontinuation
timeFrame: 1 year
Secondary outcomes:
measure: Forced expiratory volume in 1 sec (FEV1)
timeFrame: 1 year
measure: Forced vital capacity (FVC)
timeFrame: 1 year
measure: Body mass index
timeFrame: 1 year
measure: Pulmonary exacerbations
timeFrame: 1 year
measure: Chloride concentration
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Adult CF center, Service de Pneumologie, Cochin Hospital
Study officials:
affiliation: Hôpitaux Universitaire Paris Centre, AP-HP
name: Pierre-Regis BURGEL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05287581: Motivating Individuals With Lupus to Exercise
Official title: A Progressive Home-based Exercise Intervention for Persons With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Lupus Foundation of America
First posted: 2022-03-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Physical activity and exercise are helpful for managing symptoms like fatigue in people living with systemic lupus erythematosus (lupus; SLE). Despite research supporting physical activity participation, people with lupus are often inactive and report being afraid to exercise. To that end, this project is a pilot randomized controlled trial for examining the efficacy of a home-based behavioral intervention based on social cognitive theory and motivational interviewing for increasing physical activity and decreasing fatigue.


Eligibility criteria: Inclusion Criteria:

* diagnosis of Lupus
* be able to speak and read English
* being non-active defined as not engaging in regular activity (150 minutes or more of moderate physical activity per week)
* being impacted by fatigue defined as a score of 36 or higher on the fatigue severity scale

Exclusion Criteria:

* moderate or high risk for undertaking physical activity

Primary outcomes:
measure: Change in physical activity over time
timeFrame: Baseline and 4 months
measure: Change in Exercise over time
timeFrame: Baseline, 2, 4, and 6 months
Secondary outcomes:
measure: Change in Fatigue Severity Scale over time
timeFrame: Baseline, 2, 4, and 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT04432181: Comparison of Deviation Types Among Astigmatic Children With Or Without Amblyopia
Official title: Associated Professor, Director of Strabismus Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Astigmatism of Both Eyes
Amblyopia
Strabismus
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 62
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children age range between 7 and 13 years with ≥1,75 diopter (D) astigmatism were included. Patients with additional ocular and systemic diseases were excluded in this study. Subjects with and without amblyopia composed group 1 and 2, respectively.

Brief summary: the records of astigmatic children were reviewed and any deviation was investigated at near and distance. refractive errors, stereopsis, convergence insufficiency were also evaluated. children were divided into two groups according to the presence of amblyopia and ocular deviations and other parameters were compared between groups.

Detailed description: The aim of the study was to evaluate deviations in children with ≥1,75 diopter (D) astigmatism with or without amblyopia.

The records of children with ≥1,75 D astigmatism were investigated. Subjects with and without amblyopia composed group 1 and 2, respectively. The mean age, gender, amount and type of deviation, presence of convergence insufficiency (CI), stereopsis, time of initial spectacle use and follow-up time, differences in best corrected visual acuity (VoD) and spherical equivalent (SE) between eyes were noted and compared between the groups. Best corrected visual acuity (BCVA), mean SE, astigmatism measurements were also noted and compared between amblyopic, fellow and non-amblyopic eyes.

Eligibility criteria: Inclusion Criteria:

* astigmatisma ≥1,75 Diopter

Exclusion Criteria:

* systemic diseases additional ocular diseases neurological diseases

Primary outcomes:
measure: ocular deviation
timeFrame: 24 month
Secondary outcomes:
measure: convergence
timeFrame: 24 month
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University Ophthalmology Department
Study officials:
affiliation: Sakarya University
name: Burcin Cakir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02047695: Women With Migraine With Aura Neuroimaging Study
Official title: Women With Migraine With Aura Neuroimaging (WOMAN) Study: A Population-based Study of Danish Twins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine With Aura
Keywords: migraine with aura
migraine
case-control study
magnetic resonance imaging
brain diseases
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Glostrup University Hospital, Copenhagen
name: Copenhagen University Hospital, Hvidovre
name: University of Southern Denmark
First posted: 2014-01-28
Enrollment: 345
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Selected from a population-based twin registry

Brief summary: The purpose of this study is to investigate whether a particular form of migraine, migraine with aura, is associated with structural changes in the brain


Eligibility criteria: Inclusion Criteria:

* female
* case (migraine with aura), co-twin to case, or control (migraine-free)
* residency in Denmark
* no severe neurological (vascular, neurodegenerative or neuroinflammatory) disorders, or other somatic or psychiatric disorders

Exclusion Criteria:

* male
* residency outside Denmark
* registered in Civil Registry as not to be contacted by researchers
* severe neurological (vascular, neurodegenerative or neuroinflammatory) disorders, or other somatic or psychiatric disorders
* mobile metal parts or other contraindication for MRI
* weight of 130+ kilograms
* pregnancy
* subjects that wished not to be informed about abnormal findings on MRI
* chronic tension-type headache, medication overuse headache, or cluster headache (diagnosed through physician interview)
* frequent tension-type headache (control group only, self-reported or diagnosed through physician interview)

Primary outcomes:
measure: Evidence of white matter hyperintensities or subclinical ischaemic stroke confirmed by MRI
timeFrame: At time of MRI
Secondary outcomes:
measure: Evidence of other structural and functional changes in brain
timeFrame: At time of MRI
Other outcomes:
Locations:
Study officials:
affiliation: Department of Neurology, Odense University Hospital
name: David Gaist, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03771495: The Immediate Effects of Passive Hip Joint Mobilization on Hip Muscle Strength in Patients With Anterior Knee Pain
Official title: What Are the Immediate Effects of Passive Hip Joint Mobilization on Hip Abductor/External Rotator Muscle Strength in Patients With Anterior Knee Pain and Impaired Hip Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Knee Pain Syndrome
Patellofemoral Pain Syndrome
Keywords: mobilization
muscle strength
hip abductors
hip external rotators
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the immediate effects of passive hip joint mobilisation (in comparison to a sham mobilisation) on eccentric hip abductor/external rotator muscle strength on the basis of manual muscle testing with a hand-held-dynamometer within a double-blinded cross-over study design. Patients with anterior knee pain and signs of impaired hip function will be recruited in Vienna and surrounding area, measurements/data collection will be conducted by two experienced physiotherapists in a physiotherapy group practice in 1150 Vienna.


Eligibility criteria: Inclusion Criteria:

* diagnosis: anterior knee pain
* Prescription for physiotherapeutic treatment of anterior knee pain
* signs of functional hip impairment:
* impaired hip kinematics during single leg squat
* reduced passive hip joint mobility in comparison to the other, unaffected side
* manually weak tested hip abductors/external rota-tors in comparison to the other, unaffected side

Exclusion Criteria:

* intraarticular knee pathology
* preceding trauma/operation of lower extremity on affected side
* spinal disorders associated with low back pain, lumbar referred pain or nerve root irritation
* severe and/or recurring ankle sprains in recent history (significant enough, that it required a period of immobilization)
* other relevant comorbidities such as neurologic/rheumatologic/psychiatric diseases, osteoporosis and malign disorders
* pregnancy

Primary outcomes:
measure: Muscle Strength
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Praxisgemeinschaft "Bewegungsoase"
Study officials:
affiliation: Sheffield Hallam University
name: Sionnadh McLean
role: STUDY_DIRECTOR
References:
citation: Pfluegler G, Borkovec M, Kasper J, McLean S. The immediate effects of passive hip joint mobilization on hip abductor/external rotator muscle strength in patients with anterior knee pain and impaired hip function. A randomized, placebo-controlled crossover trial. J Man Manip Ther. 2021 Feb;29(1):14-22. doi: 10.1080/10669817.2020.1765625. Epub 2020 May 26.
Clinical trial NCT01300195: Prediction of Persistent Postsurgical Pain After Video-assisted Thoracic Surgery (VATS)
Official title: Factors Predicting Persistent Post-surgical Pain After Video-assisted Thoracic Surgery (VATS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Postoperative
Keywords: VATS
standardized surgery
persistent pain
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Dept. of thoracic Surgery
name: Dept. of cardio-thoracic anaesthesia
name: Dept. Surgical PAthophysiology
name: all Blegdamsvej 9, 2100-Copenhagen, Denmark
First posted: 2011-02-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung cancer patients

Brief summary: Prospective cohort study of factors predisposing to persistent post surgical pain after video-assisted thoracic surgery


Eligibility criteria: Inclusion Criteria:

* Age \< 18 years old
* Elective lung cancer surgery (VATS)

Exclusion Criteria:

* do not understand Danish
* cognitive reduction
* bilateral procedure planned
* previous thoracic surgery
* pregnant or nursing
* known nerve affection from other cause
* alcohol/substance abuse
* inability to cooperate to pain scoring/sensory examination
* \> 5 mg methylprednisolone/day

Primary outcomes:
measure: Persistent post surgical pain
timeFrame: 3 months
measure: Analgesic use
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Section for Surgical Pathophysiology 4074
Study officials:
References:
citation: Werner MU, Ringsted TK, Kehlet H, Wildgaard K. Sensory testing in patients with postthoracotomy pain syndrome: Part 1: mirror-image sensory dysfunction. Clin J Pain. 2013 Sep;29(9):775-83. doi: 10.1097/AJP.0b013e318277b646.
Clinical trial NCT00241995: Antiglutamate Anticonvulsants in the Treatment of Alcohol Withdrawal Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Topiramate
Lamotrigine
Memnatine
Diazepam
Placebo
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2005-10-19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is aimed to evaluate the efficacy of antiglutamate anticonvulsants (topiramate, lamotrigine, and memantine) in the treatment of alcohol withdrawal syndrome


Eligibility criteria: Inclusion Criteria:

Alcohol dependence Alcohol withdrawal syndrome

Exclusion Criteria:

Drug dependence Major psychiatric diagnoses Severe somatic illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St. Petersburg State Pavlov Medical University
name: Evgeny M Krupitsky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03675295: Efficacy of Hyalase Hydro-dissection in Treatment of Carpal Tunnel: Randomized Double Blind Controlled Clinical Trial
Official title: Efficacy of Hyalase Hydro-dissection in Treatment of Carpal Tunnel: Randomized Double Blind Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigate if, and to what extent, hydro-dissection using Hyalase versus saline, under ultrasound guidance, can improve the clinical condition, change in nerve conduction parameters of patients with CTS and delay or avoid the surgical intervention.
Primary purpose: TREATMENT

Brief summary: Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent hydro-dissection hyalase and saline of the median nerve could offer symptoms and clinical improvement

Detailed description: Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities. Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. It occurs at any age, especially in individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of treatment modalities have been tried to improve the condition, starting from local anesthetic injection, steroid, and up to surgical decompression of the nerves.

Eligibility criteria: Inclusion Criteria:

* adult patients
* complaining of carpal tunnel syndrome of 3 month duration or more
* diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study

Exclusion Criteria:

* patient refusal
* infection at the site of intervention
* local anesthetic allergy

Primary outcomes:
measure: pain alleviation
timeFrame: 6 months
Secondary outcomes:
measure: Changes in ultrasound imaging
timeFrame: 6 months
measure: Changes in median nerve conduction parameters
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
Clinical trial NCT05469295: CETIC-I (CEra Traction Improves Cervical Kyphosis -I)
Official title: A Prospective, Randomized, Single-blinded, Sham Device Controlled, Parallel Treatment Grouped, Multi-center, Exploratory Clinical Trial to Evaluate Improvement of Cervical Lordosis and Safety of CGM MB-1701 in Subjects With Cervical Kyphosis and Posterior Neck Pain.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Kyphosis
Cervical Lordosis
Kyphosis
Lead sponsor: Ceragem Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a Prospective, Randomized, Single-blinded, Sham device controlled, Parallel Treatment Grouped, Multi-center, Exploratory Clinical Trial to Evaluate Improvement of Cervical Lordosis and Safety of CGM MB-1701 (Spinal warm massage device, Ceragem Master V6) in Subjects with Cervical Kyphosis and Posterior Neck Pain.

Detailed description: The Cervical Kyphosis are also commonly referred to as "turtle neck syndrome." It refers to the deformation of the neck bone into an inverted C-shape due to abnormalities or degenerative changes, and it is named to mean that the neck is bent like a turtle.

This device, Ceragem Master V6 (CGM MB-1701), has been certified as a combination of a personal warmer that can be used to relieve muscle pain by applying constant heat to the human body and a medical vibrator of a device that applies physical energy (vibration, shock, pressure, etc.). Also, the device got approval for use with intermittent pneumatic compression and electrically-powered orthopedics traction.

The primary purpose of this clinical trial is to confirm the temporary cervical lordosis angle improvement (height) in subjects with cervical kyphosis through the combined function of the test device.

Eligibility criteria: Inclusion Criteria:

1. Adult male and female subjects who have voluntarily decided to participate and agreed in writing after being briefed on the characteristics of this clinical trial and medical device
2. Subjects with cervical kyphosis angle between cervical lordosis 20 degrees and cervical kyphosis 5 degrees.
3. BMI betweeen 18.5 and 30
4. Chronic neck pain NRS 4 or higher lasting more than 3 months

Exclusion Criteria:

1. Secondary spondylosis
2. A tumor of the spine
3. Inflammatory spondylitis
4. Myelopathy
5. Multiple adjacent radiculopathies and others

Primary outcomes:
measure: Mean change of cervical lordosis
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Change of cervical lordosis at 2nd interim analysis
timeFrame: up to 16 weeks
measure: Cervical vestibular angle increase more than 10 degrees
timeFrame: up to 16 weeks
measure: Anteroposterior (T1) slope average change
timeFrame: up to 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Yong Il Shin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06548295: Effects of mCIMT vs CT on Upper Extremity Motor Function and ADLs in Chronic Stroke Patients
Official title: Effects of Modified Constraint Induced Movement Therapy (mCIMT) Versus Conservative Treatment on Upper Extremity Motor Function and ADLs in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 26
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: "Cerebral palsy (CP) affects gross motor function variably, with the spastic type notably impacting movement, coordination, and balance. Research highlights that spastic CP, characterized by muscle stiffness, can severely hinder activities like walking and running.

Detailed description: Interventions such as gait training and vibrational therapy have shown promise in enhancing muscle function and body movements. A new device, EKKO, uses vibrational waves based on Neurotransmission Cognitive Theory to improve gross motor skills in children with CP by applying mechanical vibrations to nerve points. This study aims to compare the efficacy of EKKO therapy with traditional conservative treatments (such as range of motion exercises and balance training) in improving gross motor function in children with CP. Conducted over six months with randomized controlled trials, the research seeks to provide evidence-based insights into optimizing rehabilitation strategies for better motor performance and quality of life for CP patients.

Eligibility criteria: Inclusion Criteria:

* Participants will be under the age of 40-75 years
* Diagnosis: stroke

Exclusion Criteria:

* patients suffering from motor dysfunction due to other diseases (e.g., cerebral palsy, traumatic brain injury, and Parkinson's disease
* Balance problem
* Rheumatic diseases
* High spasticity

Primary outcomes:
measure: Barthal index
timeFrame: 12 Months
measure: The use of FMA-UE
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: Little angles home aziz bhati shaheed road opposit junior aps
Study officials:
References: