louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03333200: Longitudinal Study of Neurodegenerative Disorders
Official title: Longitudinal Study of Neurodegenerative Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: MLD
Krabbe Disease
ALD
MPS I
MPS II
MPS III
Vanishing White Matter Disease
GM3 Gangliosidosis
PKAN
Tay-Sachs Disease
NP Deficiency
Osteopetrosis
Alpha-Mannosidosis
Sandhoff Disease
Niemann-Pick Diseases
MPS IV
Gaucher Disease
GAN
GM1 Gangliosidoses
Morquio Disease
S-Adenosylhomocysteine Hydrolase Deficiency
Batten Disease
Pelizaeus-Merzbacher Disease
Leukodystrophy
Lysosomal Storage Diseases
Purine Nucleoside Phosphorylase Deficiency
Multiple Sulfatase Deficiency Disease
Keywords: Pediatric
Rare
Neurodegenerative
Genetic
Neurodevelopment
Brain
MRI
Biorepository
NDRD
Longitudinal
Cognitive
Motor
Language
Adaptive behavior
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 1500
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: Persons with genetic neurodegenerative diseases.

Brief summary: The purpose of this study is to understand the course of rare genetic disorders that affect the brain. This data is being analyzed to gain a better understanding of the progression of the rare neurodegenerative disorders and the effects of interventions.

Detailed description: Patients would be evaluated by a multidisciplinary team at specific time points every 3 months the first year, every 6 months the second year and once a year thereafter.

Eligibility criteria: Inclusion Criteria:

* Any patient with a genetic neurodegenerative disorder

Exclusion Criteria:

* none

Primary outcomes:
measure: Cognitive development
timeFrame: 15 years
measure: Language development
timeFrame: 15 years
measure: Gross Motor development .
timeFrame: 15 years
measure: Fine Motor development
timeFrame: 15 years
measure: Adaptive living skills
timeFrame: 15 years
Secondary outcomes:
measure: Exploratory biomarkers
timeFrame: 15 years
measure: Neurodegeneration of the brain as measured by MRI diffusion tensor imaging from birth to 5 years of age
timeFrame: 5 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03654300: A Volunteer Study to Collect Imaging Data for the Development of the Medaphor Anatomy Guide.
Official title: A Volunteer Study to Collect Imaging Data for the Development of the Medaphor Anatomy Guide.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound Imaging of Anatomical Structures
Lead sponsor: Medaphor Limited
Sponsor class: INDUSTRY
First posted: 2018-08-31
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers, male and female, aged 18 years or more.

Brief summary: The aim of this study is to determine if machine learning can be used to automatically highlight key anatomy on the ultrasound image to help anaesthetists perform ultrasound-guided regional anaesthesia.

Detailed description: The study will involve adult volunteers who are willing to be scanned by a trained sonographer to collect ultrasound video data for the following categories:

* Adductor canal
* Popliteal fossa
* Fascia Iliaca
* Rectus sheath
* Axillary region Each volunteer will be scanned to collect data for every category in the list. Where applicable, both sides of the body will be scanned.

The videos will be segmented by hand to identify the relevant anatomical regions for each category.

The primary objective for this study is to provide the range of data required to develop robust models in conjunction with additional data from patients undergoing a Peripheral Nerve Block procedure that are able to produce the desired segmentation on the unseen validation images. The models will be scored using the standard "Mean intersection over Union" pixel-level metric for semantic segmentation.

Eligibility criteria: Inclusion Criteria:

1. Male or female, at least 18 years of age;
2. Willing to undergo ultrasound scanning and provide ultrasound video data for the following categories:

   * Adductor canal
   * Popliteal fossa
   * Fascia Iliaca
   * Rectus sheath
   * Axillary region
3. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

1. Aged \<18 years of age;
2. Unwilling or unable to provide informed consent.

Primary outcomes:
measure: Model development
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Medicentre
Study officials:
References:
Clinical trial NCT01245400: Safety and Efficacy Study of the Z-Lig Medical Device Compared to Allograft
Official title: A Prospective, Randomized, Double-Blind, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the Z-Lig Medical Device Compared to Allograft for the Reconstruction of Ruptured Anterior Cruciate Ligaments
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ruptured Anterior Cruciate Ligaments
Keywords: Z-Lig
allograft
ACL
Anterior Cruciate Ligament
ACLR
Anterior Cruciate Ligament Reconstruction
EU
European Union
S. Africa
Reconstruction of ruptured anterior cruciate ligaments
Lead sponsor: Aperion Biologics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this Trial is to demonstrate the safety and efficacy of the Investigational Device for the treatment of ruptured Anterior Cruciate Ligament (ACL) of the knee compared to Allograft.

Detailed description: Current techniques to reconstruct ruptured ACLs utilize either autologous tissue or allograft (cadaver) tissue. Both treatments have well-documented shortcomings (i.e., autologous tissue exposes patients to increased morbidity and allograft tissue use is limited by global availability and quality).

There are currently no effective artificial materials or xenograft tissue substitutes widely available. The purpose of this multicenter clinical trial is to evaluate the safety and efficacy of the Z-Lig in Subjects who require reconstruction of primary ruptured anterior cruciate ligaments and compare those results to allograft.

Eligibility criteria: Contact Sponsor

Primary outcomes:
measure: KT-1000
timeFrame: baseline, 3,6, 12 & 24 monhts
Secondary outcomes:
Other outcomes:
Locations:
city: Contact Sponsor
country: Belgium
city: Contact Sponsor
country: Denmark
city: Bologna
country: Italy
city: Contact Sponsor
country: Netherlands
city: Contact Sponsor
country: South Africa
city: Contact Sponsor
country: Spain
Study officials:
References:
Clinical trial NCT03519100: Rhinoplasty and Quality of Life
Official title: Rhinoplasty and Quality of Life: Prospective Multicenter Study Before and After Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rhinoplasty
Quality of Life
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 50
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: patients will involved during surgery

Brief summary: Quality of life and satisfaction in aesthetic surgery is still under-evaluated. It is a prospective and multicenter study with a 4 months follow-up of patients under rhinoplasty or rhinoseptoplasty procedure. They will answer to the FACE-Q and NOSE questionnaires before surgery, one week later and 4 months after the procedure. The aim of the study is to show a significant augmentation of the quality of life scores. At this occasion, the FACE-Q questionnaire has been translated and validated in French

Detailed description: The main objective of this study is to show the efficiency of the rhinoplasty or rhinoseptoplasty procedure on the quality of life in a French population. There are many Patients reported outcomes questionnaire in aesthetic surgery but none of them is perfect. The FACE-Q rhinoplasty modules questionnaires is a recent test which has been validated in English but not in French. It is able to evaluate different areas of the quality of life and patient satisfaction. After French validation of the FACE-Q, this study will compare patient satisfaction before and after rhinoplasty or rhinoseptoplasty procedure. There is a lack of studies in the French population about rhinoseptoplasty surgery and quality of life or satisfaction. The goal is to show the interest of a surgery procedure on the feeling of the patients, concerning very different domains of appearance. This could help us to define the preoperative patients who are able to be really improved by this surgery

Eligibility criteria: Inclusion Criteria:

* at least 18 years old,
* patient engaged for surgery procedure of rhinoplasty or rhinoseptoplasty

Exclusion Criteria:

* patient with nose surgery medical history,
* mental or physical incapacity to answer the questionnaires
* antecedent of cervico facial cancer

Primary outcomes:
measure: Change between the FACE-Q score
timeFrame: at the inclusion, one week later and 4 months after surgery
Secondary outcomes:
measure: Difference between the NOSE score
timeFrame: at the inclusion and 4 months post surgery
measure: Difference between anthropometrics measures
timeFrame: before and immediate post surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: UH Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: de GABORY Ludovic
role: STUDY_DIRECTOR
References:
Clinical trial NCT01882400: Assessment of Response to Treatment of Osteoporosis With Oral Bisphosphonates in Patients With Muscular Dystrophy
Official title: Évaluation Multidimensionnelle de la réponse au Traitement de l'ostéoporose spontanée et Induite Par Les corticostéroïdes à l'Aide d'un Bisphosphonate à Administration Orale Chez Des Malades Porteurs d'Une Dystrophie Musculaire sévère.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Muscular Dystrophy
Cystic Fibrosis
Keywords: Osteoporosis
Severe muscular dystrophy
Cystic fibrosis
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Procter and Gamble
First posted: 2013-06-20
Enrollment: 11
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: By supplying an adequate amount of calcium and vitamin D with the addition of weekly bisphosphonate, the investigators will be able to increase bone mass and decrease the incidence of fragility fractures in these children with muscular dystrophy.

The investigators think this treatment will also decrease the intensity of pain frequently present in these patients and slow the progression of scoliosis.

Detailed description: Children with muscular dystrophy, as well as children with other chronic diseases (e.g. cystic fibrosis, chronic inflammatory arthritis) are at risk to develop fragility fractures both due to the disease itself and to drugs (mostly corticosteroids) used to treat the diseases.

In addition, children with muscular dystrophy frequently complain of diffuse pain making daily care more difficult and almost always develop structural scoliosis.

The objective of the present protocol is to offer these children a preventive treatment aimed at maintaining or increasing their bone mass. We also propose that maintaining bone mass will decrease fracture rates, as well as pain and the rate of progression of scoliosis.

Rigorous care to ensure adequate intake of calcium and vitamin D, as well as addition of a weekly bisphosphonate, are the central aspect of the project. In addition, we will monitor to avoid possible side-effects such as hypercalciuria and kidney stones.

Eligibility criteria: Inclusion Criteria:

* Osteoporosis or osteopenia
* Severe muscular dystrophy or cystic fibrosis
* May use corticosteroids

Exclusion Criteria:

* Inability to consent or to take drugs by mouth

Primary outcomes:
measure: Increase in bone density according to osteodensitometry
timeFrame: Over 2 years of treatment
Secondary outcomes:
measure: Decrease in bone pain
timeFrame: Over the first 2 years of treatment
measure: Retardation of scoliosis development
timeFrame: Over the first 2 years of treatment
Other outcomes:
measure: Side effects of treatment
timeFrame: Over 2 years
Locations:
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: CHUS and Université de Sherbrooke
name: Gilles Boire, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05101200: Dose Response of Neural Mobilization on Hamstring Flexibility in Low Back Pain
Official title: Dose Response of Neural Mobilization on Hamstring Flexibility in Patients With Non-specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-specific Low Back Pain
Keywords: Neural Mobilization Technique
Oswestry Disability Index
Active Knee Extension Test
Numeric Pain Rating Scale
Lumbar flexion by Schober method
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be a randomized control trial and will be conducted in Riphah International Hospital, National orthopedic and specialist hospital, Riphah international hospital and Chambeli institute of physiotherapy. A sample of 34 participants will be taken. Participants will be randomized into Group A and Group B through lottery method. Group A will receive High Dose Neural Mobilization Technique, Hot pack for 15 minutes, strengthening exercises with 10rep/8sets , strengthening exercises for quadriceps and static stretching exercise for hamstring with 10 rep/8sets, While Group B will receive Low Dose Neural Mobilization Technique with minimal intensity, hot pack: 15 minutes, strengthening exercises with 10rep/4sets. Both groups will be given session of 40 min/day, 2 days/week for 4 weeks, assessment will be done at baseline, at the end of 1st week, 2nd week, 3rd week \& at the end of 4th week. The outcome measure will be Numeric Pain Rating Scale (NPRS), Oswestry Disability Index (ODI), Active Knee Extension test (AKE) and Lumbar flexion by Schober method. Data will be analyzed be SPSS 22.


Eligibility criteria: Inclusion Criteria:

* Low back pain \> 3 months
* No exercises for last 6 months
* Non-specific LBP in its sub-acute \& chronic phase

Exclusion Criteria:

* Specific causes of LBP (disc herniation, lumbar stenosis, spinal deformity, fracture, spondylolisthesis),
* Central or peripheral neurologic signs
* Systemic illness (tumor and rheumatologic diseases),
* Psychiatric and mental deficits.
* Patients who had undergone operations within 6 months

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 4 Weeks
measure: Oswestry Disability Index (ODI)
timeFrame: 4 Weeks
measure: Active Knee Extension test for hamstring flexibility
timeFrame: 4 Weeks
measure: Lumbar flexion by Schober method
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: National orthopedic and specialist hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Waqar Ahmed Awan, Ms-OMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06463600: Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy.
Official title: Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy. A Randomised Pilot Feasibility Study: MagLocal 1.0
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Conserving Surgery
Keywords: Breast cancer
Tumour localisation
Magnetic clip
magnetic tracer
Preoperative chemotherapy
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One part feasibility and one part randomised.
Primary purpose: TREATMENT

Brief summary: The feasibility of the use of magnetic clips for tumour localisation before preoperative chemotherapy in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection and in combination with a magnetic clip in the index lymph node metastasis is studied.

Detailed description: The overall aim is to demonstrate that the use of magnetic clips for tumour localisation before preoperative chemotherapy is feasible at breast cancer surgery and histopathological evaluation in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection, and in combination with a magnetic clip in the index lymph node metastasis if targeted axillary surgery is planned.

Eligibility criteria: Inclusion Criteria:

1. Age above 18 years
2. Planned for preoperative chemotherapy before breast cancer surgery
3. Planned breast conserving surgery with targeted axillary dissection or sentinel lymph node biopsy using magnetic technique
4. SLN-biopsy with magnetic tracer or targeted axillary dissection using magnetic tracer and Magseed
5. Signed and dated written informed consent before the start of specific protocol procedures

Exclusion Criteria:

1. Pregnant or breast-feeding
2. Iron overload disease
3. Known hypersensitivity to iron or dextran compounds
4. Inability to understand given information and give informed consent or undergo study procedures
5. Planned MRI control for tumour response during chemotherapy

Primary outcomes:
measure: Specimen volume
timeFrame: Perioperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska Academy at Gothenburg University
state: Göteborg
Study officials:
affiliation: Sahlgrenska Academy at Gothenburg University
name: Roger Olofsson Bagge, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06502600: Factors Affecting Surgical Recovery in Hospital Patients
Official title: A Comprehensive Analysis of Factors Influencing Adverse Postoperative Outcomes in Hospitalized Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospitalized Surgical Patients
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients of all inpatient surgeries conducted at a major comprehensive hospital.

Brief summary: The objective of this observational study is to elucidate the factors influencing adverse postoperative outcomes in hospitalized surgical patients. The primary questions addressed are:

What factors contribute to the occurrence of adverse outcomes following surgery? How can the risks be mitigated to achieve improved postoperative outcomes?


Eligibility criteria: Inclusion Criteria:

* The study population consisted of all patients who had undergone surgery, with no instances of severe data missingness.

Exclusion Criteria:

* Missing data were identified where the rate of missingness was greater than 20%

Primary outcomes:
measure: Death
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University,
state: Zhejiang
Study officials:
References:
Clinical trial NCT00165100: Dynamic Area Telethermometry (DAT) as an Imaging Modality in Patients With Cancer
Official title: Dynamic Area Telethermometry (DAT) as an Auxiliary Imaging Modality in Assessment of Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Tumors
Subcutaneous Tumors
Lymph Node Tumors
Keywords: DAT
imaging modality
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2005-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate whether this new method of taking pictures called Dynamic Area Telethermometry (DAT) might be a good way of looking at patients with cancer that is relatively close to the surface of the body.

Detailed description: * The DAT system resembles a video camera which picks up changes in body temperature which may reflect disease-related changes in blood flow to some areas, particularly those involved with tumors.
* Patients with known tumor sites amendable to DAT evaluation will be imaged at the time of staging and at later time points. Thermal profiles will be compared to those of normal adjacent tissues and correlated with the images of the tumors on conventional images.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed malignancy
* Primary or secondary tumor location amendable to DAT scanning: subcutaneous tissues
* Older than 15 years of age
* Able to withhold movement for 20 seconds, hold breath for 20 seconds for chest wall lesions and clinically stable acutely

Exclusion Criteria:

* Uncontrolled motion
* Tumors not verified or measurable by standard imaging

Primary outcomes:
measure: To assess the feasibility of DAT in tumors detected by conventional imaging and evaluation of therapy induced changes in DAT imaging profile over time.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Milos Janicek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: