louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05776602: Fast Brain MRI in Children With Suspected Brain Tumor
Official title: Fast Brain MRI in Children With Suspected or Confirmed Brain Tumor
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Magnetic Resonance Imaging
Brain Neoplasms, Childhood
Brain Neoplasms
Brain Tumor
Diagnosis
Image
Neuroimaging
Pediatric
Keywords: Neuro
Imaging
MRI
Diagnostic accuracy
Neuroimaging
Fast MRI
Neuromix
Pediatric
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children up to 18 years with suspected or confirmed brain tumor investigated in standard clinical care with MRI of the brain.

Brief summary: This study aims to assess the diagnostic performance of a new fast MRI sequence named Neuromix compared to routine clinical MRI for brain tumor in pediatric patients

Detailed description: The study aims to assess the diagnostic performance of fast MR sequence for the radiological evaluation of brain tumor in comparison to routine clinical MRI (or reference standard) in a pediatric population.

The primary outcome is the depiction and characterization of normal brain, brain tumor pathology and incidental findings.

Sensitivity, specificity, AUC and intra-/ interreader agreement for the diagnostic performance of Neuromix compared to cMRI will be obtained. Correlation of results between methods will be calculated.

Secondary outcomes will also include the assessment of diagnostic image quality and image artifacts.

The study population will consist of subjects aged 0-18 with a suspected or diagnosed brain tumor referred for routine MRI examination of the brain.

Study subjects will be investigated during the same day at 3T MR with Neuromix sequence in addition to the routine MRI examination.

Volume measurements will be compared.

Eligibility criteria: Inclusion Criteria:

* Age 0-18 years.
* Pediatric subjects with diagnosed or suspected brain tumor
* Referral routine MRI study.

Exclusion Criteria:

* MRI planned without sedation
* Aborted MR exam
* Unstable patient

Primary outcomes:
measure: Diagnostic performance
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Imaging artifacts
timeFrame: through study completion, an average of 1 year
measure: Imaging quality
timeFrame: through study completion, an average of 1 year
measure: Correlation
timeFrame: through study completion, an average of 1 year
measure: Agreement
timeFrame: through study completion, an average of 1 year
measure: Sensitivity
timeFrame: through study completion, an average of 1 year
measure: Specificity
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinksa Universitetssjukhuset
Study officials:
affiliation: Karolinska Institutet
name: Anna Falk Delgado, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06478602: Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis
Official title: Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Liver Cirrhosis
Lead sponsor: Academic Emergency County Hospital Sibiu
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to investigate the beneficial effects of fecal transplantation in patients diagnosed with liver cirrhosis (regardless of etiology).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of liver cirrhosis according to current protocols.
* Conscious and cooperative adult patients.

Exclusion Criteria:

* Patients with hemodynamic and/or respiratory instability.
* Patients with contraindications for colonoscopy or fecal transplantation.
* Patients with acute or chronic infections with HIV, Tuberculosis, MDR Enterobacteria, CMV, parasites, fungi.
* Associated oncological pathology.
* Patients with other causes of severe immunodeficiencies.
* Lack of compliance with the conditions imposed by the research project.
* Patients who do not sign the informed consent.

Primary outcomes:
measure: Implications of fecal microbiota transplantation in modulating the effects of liver cirrhosis.
timeFrame: Up to 3 months
measure: Implications of fecal microbiota transplantation in modulating the condition of other organs.
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sibiu
country: Romania
facility: County Clinical Emergency Hospital of Sibiu
Study officials:
affiliation: County Clinical Emergency Hospital of Sibiu
name: Victoria Birlutiu, Prof. Dr.
role: STUDY_CHAIR
affiliation: County Clinical Emergency Hospital of Sibiu
name: Adrian Boicean, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Boicean A, Birlutiu V, Ichim C, Brusnic O, Onisor DM. Fecal Microbiota Transplantation in Liver Cirrhosis. Biomedicines. 2023 Oct 30;11(11):2930. doi: 10.3390/biomedicines11112930.
citation: Boicean A, Ichim C, Todor SB, Anderco P, Popa ML. The Importance of Microbiota and Fecal Microbiota Transplantation in Pancreatic Disorders. Diagnostics (Basel). 2024 Apr 23;14(9):861. doi: 10.3390/diagnostics14090861.
citation: Boicean A, Birlutiu V, Ichim C, Anderco P, Birsan S. Fecal Microbiota Transplantation in Inflammatory Bowel Disease. Biomedicines. 2023 Mar 27;11(4):1016. doi: 10.3390/biomedicines11041016.
Clinical trial NCT03978702: Evaluation of the Impact of Pancreatectomy on Systemic Immunity
Official title: Pancreatic Surgery: Evaluation of the Impact of Pancreatectomy on Systemic Immunity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreas Cancer
Pancreatectomy; Hyperglycemia
Keywords: Pancreatectomy
Immune system
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims at establishing the profile of the immune reaction that occurs in the early surgical suites after pancreatectomy. Blood samples will be collected before surgery, (Day-1), at day0, and after surgery at Day 1, Day 3, Day 7 at 1 year after pancreatectomy. Mass cytometry, genomic and transcriptomic approaches will be used to evaluate the immune systemic modulation after surgery.


Eligibility criteria: Inclusion Criteria:

* Patient with an indication of pancreatectomy
* Signed consent form

Exclusion Criteria:

* Neoadjuvant treatment
* Pregnancy

Primary outcomes:
measure: Measurement of immune effectors (Tcells, NK) levels after pancreatectomy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Olivier Turrini, MD ¨PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03645902: Comparison Between TOF and SWAN Sequences in the Detection of Arterial Occlusion in Acute Ischemic Stroke Using MRI
Official title: Comparison Between Enhanced Susceptibility-weighted Angiography and Time of Flight Sequences in the Detection of Arterial Occlusion in Acute Ischemic Stroke Using MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Angiography
Magnetic Resonance Imaging
Diagnosis
Keywords: Acute stroke
Susceptibility-weighted imaging
Arterial occlusion
Time of flight
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients included in this prospective study will be recruited at Saint-Philibert Hospital -Lomme, France, when presenting symptoms of an acute stroke

Brief summary: Optimizing the MRI protocol in acute ischemic stroke remains a challenging issue. In this field, susceptibility-weighted sequences have proved their superiority over T2. Besides the strengthened susceptibility effect, enhanced susceptibility-weighted angiography (eSWAN) sequence provides also a time-of-flight (TOF) effect, allowing the exploration of the intracranial arterial circulation. The objective of this study is to compare eSWAN and 3D TOF, considered as the reference, in the detection of arterial occlusion in acute stroke.

Detailed description: Patients who undergo MRI for suspected acute stroke with an acute ischemic lesion on diffusion-weighted imaging (DWI) will be prospectively included in this study.eSWAN and TOF images will be analyzed under double-blind conditions by a junior radiologist and a senior neuroradiologist for the detection of arterial occlusion. eSWAN images will be assessed in order to estimate the inter-observer agreement. After a consensus, eSWAN and TOF data will be compared to calculate inter-modality agreement.

Eligibility criteria: Inclusion Criteria:

* clinical symptoms compatible with acute stroke;
* time range between symptoms and magnetic resonance imaging less than 4 h 30
* presence of at least one acute ischemic lesion on the diffusion-weighted images (DWI).

Exclusion Criteria:

* MR contraindications;
* negative DWI;
* differential diagnosis;
* incomplete acquisition of the full magnetic resonance imaging protocol or technical issues leading to uninterpretable eSWAN and/or TOF sequences (e.g.motion artifacts).

Primary outcomes:
measure: Concordance of observed agreement using eSWAN and TOF images measured by Cohen's kappa coefficient
timeFrame: at inclusion
Secondary outcomes:
measure: Concordance inter-observer agreement for the detection of arterial occlusion using eSWAN images measured by Cohen's kappa coefficient
timeFrame: at inclusion
Other outcomes:
Locations:
Study officials:
affiliation: GHICL
name: Sebastien Verclytte, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03869502: European CML Blast Crisis Register
Official title: European CML Blast Crisis Register
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Myeloid Leukemia in Myeloid Blast Crisis
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with CML Blast crisis, either newly diagnosed or as evolution of a CML in chronic phase

Brief summary: Multicentric prospective and retrospective register collecting patient with CML blast crisis diagnosed in Germany and Europe

Detailed description: Since the advent of treatment with tyrosine kinase inhibitors (TKI), the incidence of blast crises has significantly decreased. Nevertheless, about 5% of patients diagnosed with chronic myeloid leukemia (CML) will evolve into a blast phase at some point during the course of their disease. Furthermore, despite the advances made in CML treatment, outcome of patients with blast crises are still dismal. Due to the rarity of this condition clinical trials are challenging, and collaboration between researchers both at national and international level is needed to collect a meaningful number of data.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Diagnosis of BCR-ABL positive CML blast crisis according to the WHO criteria:

  * Blasts 20% or more of peripheral blood white cells or bone marrow cells or
  * Extramedullary blast proliferation or
  * Large foci or clusters of blasts in bone marrow biopsy

Exclusion Criteria:

* Lack of informed consent

Primary outcomes:
measure: Overall survival
timeFrame: through study completion in 2024
Secondary outcomes:
measure: Rate of hematologic response to treatment
timeFrame: through study completion in 2024
measure: Rate of molecular response to treatment
timeFrame: through study completion in 2024
measure: Rate of blast crises in Europe in the era of TKI treatment
timeFrame: through study completion in 2024
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Masaryk University Hospital Brno
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Jena
country: Germany
facility: University Hospital Jena
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
city: Münster
country: Germany
facility: Universitaetsklinikum Muenster
city: Saint Petersburg
country: Russian Federation
facility: I. P. Pavlov First St. Petersburg State Medical University
city: Kiev
country: Ukraine
facility: National Research Center for Radiation Medicine
Study officials:
affiliation: Univerity of Jena
name: Annamaria Brioli, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01597102: Cerebrovascular Autoregulation During and After Liver Transplantation
Official title: Cerebrovascular Autoregulation During and After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Encephalopathy, Hepatic
Cerebrovascular Disorders
Liver Failure
Keywords: encephalopathy, hepatic
autoregulation, cerebrovascular
liver failure
liver transplantation
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2012-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with and stage liver failure and transplantation

Brief summary: The cerebrovascular autoregulation (AR) is impaired in patients with hepatic encephalopathy. Patients with the indication to liver transplantation mostly have mild to severe hepatic encephalopathy. Transplantation should recover the encephalopathy. The aim of the study is to investigate the AR during liver transplantation, with the questions if the AR is impaired at the beginning of surgery and if there are changes in AR. For follow up the AR will be measured at the first days after transplantation at the ICU.

Detailed description: The cerebrovascular autoregulation (AR) will be measured using transcranial doppler and calculating the index of autoregulation Mx. This measurement is continuous with online calculation. So, the possible changes over the whole time of surgery can be detected. Furthermore, the measurement of AR at the ICU will be performed daily at the same time over a measurement period of 60 Minutes and the time course of AR after liver transplantation will be described.

Eligibility criteria: Inclusion Criteria:

* liver transplantation
* age \> 18 years

Exclusion Criteria:

* sepsis
* preexisting cerebral diseases
* traumatic brain injury
* pregnancy

Primary outcomes:
measure: Changes of cerebrovascular autoregulation during liver transplantation
timeFrame: During the surgery
Secondary outcomes:
measure: Time course of cerebrovascular autoregulation after liver transplantation
timeFrame: First 4 days after transplantation
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center
Study officials:
affiliation: Johannes Gutenberg University Mainz
name: Patrick Schramm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02759302: MRI on Persons With Mutations in POMT2 Gene (LGMD2N)
Official title: MRI on Persons With Mutations in POMT2 Gene (LGMD2N)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Limb-girdle Muscular Dystrophy
Keywords: MRI
LGMD
POMT2
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons diagnosed with LGMD2N in Denmark and France are invited to the study.

Brief summary: POMT2 mutation is known to cause Walker Warburg Syndrome and Muscle-Brain-Eye syndrome. Recently it has been connected to limb girdle muscular dystrophy (LGMD), a disorder characterized by muscle weakness and atrophy of the proximal muscles of the shoulder and pelvic girdles. LGMD is classified based on its inheritance pattern and genetic cause into more than 31 different types. LGMD with POMT2 mutations is a new phenotype - type 2N. Very few patients with the LGMD2N phenotype has been reported. In this study, the investigators examine five new cases with the LGMD phenotype. The primary aim is to examine the muscle involvement using MRI.


Eligibility criteria: Inclusion Criteria:

* Persons with genetically verified mutations in POMT2

Exclusion Criteria:

* All contraindications for undergoing an MRI scan

Primary outcomes:
measure: MRI scan for qualitative analysis of muscle involvement
timeFrame: One MRI scan per subject (exam lasts approximately 60 min.)
Secondary outcomes:
measure: Muscle Biopsy
timeFrame: One muscle biopsy per subject (last approximately 15 min.)
measure: 10 meter walk test
timeFrame: Exam last approximately 5 min
measure: Neurological examination and test of muscle strength
timeFrame: Exam last approximately 15 min.
measure: Questionnaires
timeFrame: Data will be collected once for patients with LGMD2N (exam last approximately 45 min.)
measure: Heart examination
timeFrame: Exam last approximately 45 min
measure: Forced Vital Capacity (FVC)
timeFrame: Exam last approximately 15 min
measure: Electromyography (EMG)
timeFrame: Exam last approximately 30 min
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Neuromuscular Center, Rigshospitalet
Study officials:
affiliation: Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, Copenhagen University
name: Sofie T. Østergaard, Bsc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ostergaard ST, Johnson K, Stojkovic T, Krag T, De Ridder W, De Jonghe P, Baets J, Claeys KG, Fernandez-Torron R, Phillips L, Topf A, Colomer J, Nafissi S, Jamal-Omidi S, Bouchet-Seraphin C, Leturcq F, MacArthur DG, Lek M, Xu L, Nelson I, Straub V, Vissing J. Limb girdle muscular dystrophy due to mutations in POMT2. J Neurol Neurosurg Psychiatry. 2018 May;89(5):506-512. doi: 10.1136/jnnp-2017-317018. Epub 2017 Nov 24.
Clinical trial NCT00460902: Evaluation of the Deep TMS H-Coil in the Treatment of Major Depression- Augmentation of Antidepressant Medication
Official title: Evaluation of the H-Coil Transcranial Magnetic Stimulation(TMS) Device- Augmentation for Drug Resistant Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Major Depression
Keywords: TMS
drug resistant depression
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-04-17
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the novel deep TMS H-Coil design as an augmentation measure in the treatment of medication resistant major depression. Stimulation is administered with and without cognitive-emotional provocation.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as suffering from treatment resistant major depression
* Right laterality

Exclusion Criteria:

* other major axis I diagnosis
* severe axis II diagnosis
* risk factors to convulsions
* history of drug abuse in the past year

Primary outcomes:
measure: HAMILTON RATING SCALE FOR DEPRESSION 24 items
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Yaacov
country: Israel
facility: Beer Yaacov Medical Center
city: Jerusalem
country: Israel
facility: Biological psychiatry unit, Psychiatric ward, Hadassah Medical organization
Study officials:
affiliation: Hadassah Medical Organization
name: Moshe Isserles, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Isserles M, Rosenberg O, Dannon P, Levkovitz Y, Kotler M, Deutsch F, Lerer B, Zangen A. Cognitive-emotional reactivation during deep transcranial magnetic stimulation over the prefrontal cortex of depressive patients affects antidepressant outcome. J Affect Disord. 2011 Feb;128(3):235-42. doi: 10.1016/j.jad.2010.06.038. Epub 2010 Jul 21.
Clinical trial NCT05558202: Turkish Version of The Lower Limb Assessment Score
Official title: Turkish Version of The Lower Limb Assessment Score : Reliability and Validity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypermobility, Joint
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - The study will be carried out by young adults and adults in the Kutahya Health Science University

Brief summary: Hypermobility is more than normal joint laxity, mobility, and range of motion. It is characterized by increased laxity and fragility of connective tissues. Symptoms from hypermobility can begin at any age and affect women more than men. People are at higher risk than other people. It is stated that hypermobility is an important factor in orthopedic injuries and diseases. Individuals with hypermobility have more frequent orthopedic complaints and the problems are usually idiopathic and chronic. Studies have reported that proprioception and musculoskeletal reflex function may be affected independently of symptoms in hypermobile individuals. Therefore, evaluating hypermobility is very important in preventing hypermobility-related problems and injuries and developing appropriate treatment methods. Although the Beighton score is the most commonly used scoring method to determine hypermobility, it may be insufficient to determine hypermobility of the lower extremities. The Lower Limb Assessment Score (LLAS) has been reported to be one of the most appropriate scoring methods for assessing lower extremity hypermobility in the literature. The aim of this study is to adapt LLAS to Turkish and measure its validity and reliability.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Aged between 18 to 35

Exclusion Criteria:

* Using assistive devices or orthoses for the upper extremity
* Surgery history of the upper extremity
* Pain located on the upper extremity in the last 6 months
* Previous trauma that might restrict normal range of motion.
* Having degenerative or inflamatuar disease

Primary outcomes:
measure: The Lower Limb Assessment Score (LLAS)
timeFrame: 10 minutes
measure: The Beighton Score
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Science University
Study officials:
affiliation: Kutahya Health Sciences University
name: Emrah Afsar, Phd
role: PRINCIPAL_INVESTIGATOR
References: