louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02573792: Optical Coherence Tomography and Optic Neuritis (OCTON)
Official title: Optical Coherence Tomography for the Etiological Diagnosis of Inflammatory Optic Neuritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optical Neuritis
Keywords: First onset of optical neuritis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-10-12
Enrollment: 120
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 seen at the Adolphe de Rothschild ophthalmological foundation for the first onset of an optical neuritis

Brief summary: Optic neuritis (ON) can remain isolated or reveal a widespread and chronic disease of the central nervous system (CNS), a multiple sclerosis (MS) or, more rarely, a Devic's neuromyelitis optica (NMO) or a systemic disease.

The optical coherence tomography (OCT) is a retinal imaging technique to measure the thickness of the retina and its different layers with an accuracy of 4-6 µM.

Costello et al have shown that approximately 75% of 54 MS patients have developed within 3 to 6 months after a ON a loss of 10 to 40 µM in the thickness of the peripapillary retinal nerve fiber layer (RNFL).

The etiologic diagnosis of ON has been transformed in recent years. MS can now be diagnosed by McDonald's MRI criteria and NMO by the AQP4 antibodies (anti-aquaporin- 4) antibodies and the anti-MOG (myelin-oligodendrocyte glycoprotein) antibodies.

The diagnosis and prognosis value of the OCT in patients with ON is not well known


Eligibility criteria: Inclusion Criteria:

* first onset of an optical neuritis lasting for less than 3 months

Exclusion Criteria:

* Contra-indication to MRI
* Patient opposed to participation in the study
* Pregnant or lactating woman
* Patient under a measure of legal protection
* Absence of affiliation to social security or universal health coverage (CMU)

Primary outcomes:
measure: Sensitivity of the OCT, expressed as a percentage, for the etiological diagnosis of optical neuritis
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
state: Ile De France
Study officials:
References:
Clinical trial NCT03166592: Evaluation of Intra Axial Brain Masses Based on Magnetic Resonance in Adults
Official title: Impact of Advanced Neuroimaging Techniques in Evaluation of Intra Axial Brain Masses Based on Magnetic Resonance Diagnostic Strategy in Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Tumor
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Magnetic resonance imaging detected brain cases referred from Neurosurgery \& Neuropsychiatry departments as well as Outpatient clinics

Brief summary: Although the Magnetic resonance imaging with contrast is the gold standard for diagnosis of intra axial brain masses. The conventional Magnetic resonance imaging appearances of intra axial brain masses can be non-specific and even the use of contrast agent is of limited benefit.

Contrast enhancement reflects only disruption of blood brain barrier. One third of high-grade malignancies are non-enhanced and may non-neoplastic lesions show contrast enhancement.

Reliable differentiation of neoplastic from non-neoplastic brain masses, or of high grade from low grade tumor, is difficult with conventional Magnetic resonance imaging


Eligibility criteria: 1. Inclusion criteria:

   \* An intra axial space occupying lesion/lesions detected on conventional structural imaging
2. Exclusion criteria:

   * MRI contraindications (as pace maker or claustrophobia).
   * Contrast hypersensitivity
   * Impaired renal function.
   * Pediatric age group

Primary outcomes:
measure: Number of patients with malignant masses
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT03928392: Does an Occupational Therapy Program Enhance Mental Health Outcomes for Veterans Who Scuba Dive
Official title: Does an Occupational Therapy Program Enhance Mental Health Outcomes for Veterans Who Scuba Dive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Depression
Anxiety
Stress, Psychological
Keywords: Post Traumatic Stress Disorder, Depression, Anxiety, Stress, SCUBA, Occupational therapy
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two groups for this study. Both groups will engage in two SCUBA dives. Additionally one group will receive occupational therapy and the other will not. The occupational therapy sessions will occur in conjunction with the SCUBA dive.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate whether an occupational therapy program could enhance mental health outcomes for veterans who SCUBA dive. SCUBA diving requires modified breathing techniques and has been found to provide calming effects to individuals who engage in this activity. Occupational therapy interventions such as mindfulness, journaling, and deep breathing techniques can also provide similar calming effects. Therefore, this study will explore whether occupational therapy can provide additional benefits to overall mental health of veterans who SCUBA dive.


Eligibility criteria: Inclusion Criteria:

* 18 to 95 years of age
* Participation in WAVES Project for at least 3 months
* Completion of 3 open water dives
* Proficient in written and verbal English

Exclusion Criteria:

* Younger than 18 years of age or older than 95 years of age
* Not a member of WAVES Project within 3 months of study recruitment
* Has not completed 3 open water dives
* Not proficient in written and verbal English

Primary outcomes:
measure: Satisfaction With Occupational Performance
timeFrame: Change between baseline and three weeks.
Secondary outcomes:
measure: The PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Change between baseline and three weeks
measure: The Depression Anxiety and Stress Scales (DASS)
timeFrame: Change between baseline and three weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Universtiy
state: California
Study officials:
affiliation: Loma Linda University Health
name: Dragana Krpalek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03196492: Vaginal Microbiota, and STI/HIV Risk Among Adolescent Girls and Young Women
Official title: Effect of Injectable Contraceptives on Inflammation, Vaginal Microbiota, and STI/HIV Risk Among Adolescent Girls and Young Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microbial Colonization
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of Maryland, College Park
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-06-22
Enrollment: 234
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy 13-24 Adolescent Girls and Young Women

Brief summary: The investigators are doing a study on the bacteria that normally live in the vagina and what effect, if any, Depo-Provera has on the bacteria.

Women 13-24 years of age, who are HIV negative, being seen in a clinic for birth control or sexually transmitted disease (STD) check-up, or have a child and are planning to receive a Depo-Provera shot for contraception or have declined the use of hormonal contraception may join.

Detailed description: The investigators are doing a study on the bacteria that normally live in the vagina and what effect, if any, Depo-Provera has on the bacteria.

Women 13-24 years of age, who are HIV negative, being seen in a clinic for birth control or STD check-up, or have a child and are planning to receive a Depo-Provera shot for contraception or have declined the use of hormonal contraception may join.

Eligibility criteria: Inclusion Criteria:

* Age 13-24
* Female sex
* Seeking contraceptive/ STI services OR has had a child OR is legally married
* Has had consensual vaginal sex
* Two years have passed since menses started
* HIV negative by self-report
* Willing to refrain from using douches, washes, or other similar feminine hygiene products. (Tampons are allowed)
* Planning to receive the Depo-Provera shot, -OR- Have regular menstrual cycles with at least 21 - 45 days between menses and plans to use no hormonal birth control.

Exclusion Criteria:

* Any other immunodeficiency (e.g. organ transplant recipient)
* Recently pregnant (within 4 weeks), currently pregnant, or planning to become pregnant within the next 12 months
* Currently breastfeeding
* Hysterectomy or a known genital tract anomaly
* Amenorrhea (except if caused by contraceptive method like the implant)
* Antibiotic or antifungal use within past 30 days

Primary outcomes:
measure: Association between lactobacillus-dominant microbiota and sexually transmitted infections (STI)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jenell Coleman Fennell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01909492: Measurement of Relaxin Peptide in Multiple Sclerosis (MS)
Official title: Measurement of Relaxin in the Serum and Cerebrospinal Fluid of Subjects With and Without the Relapsing Form of Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
MS
Relaxin
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
Collaborators: name: Microstein, LLC
First posted: 2013-07-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected MS undergoing a lumbar puncture for diagnosis, patients with stable MS willing to participate in the study, and patients without MS having a lumbar puncture as part of their non-MS disease management will be invited to participate in this study.

Brief summary: This study will evaluate relaxin (RLX) levels in patients with multiple sclerosis.

Detailed description: The goal of this study is to obtain baseline information on serum and cerebrospinal fluid (CSF) relaxin levels in patients with MS, as well as to further study RXFP-1 receptor binding affinity for RLX in patients with active and clinically stable MS.

Eligibility criteria: Inclusion Criteria:

* Subjects with suspected MS, who have had a clinical attack within the last 12 weeks, have at least one gadolinium-enhancing lesion on brain or spinal cord MRI taken within the prior 4 weeks, and for which they have not received any immunomodulating or immunosuppressant medication.
* Subjects with clinically stable definite MS, with no evidence of clinical relapse for at least the past 12 weeks, and have no gadolinium enhancing lesions on MRI in the prior 4 weeks. These subjects will fulfill the Revised (2010) McDonald's Criteria for the Diagnosis of MS.
* Subjects without evidence of inflammatory systemic or inflammatory central nervous system disease, who require CSF removal for some other cause, such treatment of benign intracranial hypertension or as part of the procedure for insertion of an intrathecal medication delivery system.

Exclusion Criteria:

- Pregnancy

Primary outcomes:
measure: Relaxin (RLX) Levels
timeFrame: During diagnostic LP
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Providence MS Center
state: Oregon
Study officials:
affiliation: Providence Brain & Spine Institute, Providence Health & Services
name: Stanley Cohan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04024592: Reliability and Validity of Strength Measurement of the Lower Limbs in Typically Developing Children
Official title: Reliability and Validity of Strength Measurement of the Lower Limbs in Typically Developing Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Muscle Strength
Reproducibility of Results
Muscle Strength Dynamometer
Knee
Keywords: child
dynamometry
knee joint
reproducability of results
strength testing
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Reliability of isokinetic strength measurement of the knee in typically developing children has yet been studied and seems to be good. Because in daily life activities strength of the hip- and ankle-joint muscles are also important, the investigators aim to study the reliability and validity of isokinetic strength measurements of the hip and ankle.

Detailed description: Intra-tester reliability of isokinetic strength measurements of the knee, hip and ankle in a Biodex System 4 device will be studied. Children will be assessed at different movement velocities using the test-positions as proposed by the manufacturer. Maximum peak torque will be established.

Children will also perform functional strength assessments and the relation with the results of isokinetic strength measurements will be analysed.

Eligibility criteria: Inclusion Criteria:

* healthy children with good intellectual capacities

Exclusion Criteria:

* children with chronic disease or intellectual deficiency

Primary outcomes:
measure: Isokinetic strength assessment with Biodex System 4 device
timeFrame: 90 minutes
Secondary outcomes:
measure: Functional strength assessment
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Ghent
name: Christine Van den Broeck, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01918592: PET/MRI and Biomarkers in Bladder Cancer
Official title: PET/MRI and Biomarkers in Clinical Staging of Bladder Cancer and in the Estimation of Neoadjuvant Chemotherapy Response Prior to Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: bladder cancer
neoadjuvant chemotherapy
radical cystectomy
lymphadenectomy
biomarker
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2013-08-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Muscle invasive bladder cancer is an aggressive malignancy. Currently the investigators lack accurate imaging technologies in clinical staging and estimation of response to neoadjuvant chemotherapy as well as prognostic biomarkers.

In the current study novel imaging modality (MRI/PET) is utilized to stage bladder cancer prior to transurethral resection of bladder-tumor and after neoadjuvant chemotherapy. Also prognostic biomarkers are studied from TUR-BT tissues, blood and urine to estimate response to neoadjuvant chemotherapy.


Eligibility criteria: Inclusion Criteria:

* invasive or locally advanced bladder cancer based on cystoscopic evaluation
* Age: 18 to 85 years old
* Language spoken: Finnish or Swedish
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease
* Infections: Patient must not have an uncontrolled serious infection
* Contraindications for MRI (cardiac pacemaker, intracranial clips etc)
* Patient refusing radical cystectomy or chemotherapy
* Intravesical Bacillus Calmette-Guerin instillations within 6 months

Primary outcomes:
measure: staging accuracy of PET/MRI in bladder cancer
timeFrame: 3 months
Secondary outcomes:
measure: Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy
timeFrame: 3 mo
Other outcomes:
measure: Accuracy of prognostic biomarkers to estimate response to neoadjuvant chemotherapy.
timeFrame: 6 mo
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References:
citation: Salminen A, Jambor I, Merisaari H, Ettala O, Virtanen J, Koskinen I, Veskimae E, Sairanen J, Taimen P, Kemppainen J, Minn H, Bostrom PJ. 11C-acetate PET/MRI in bladder cancer staging and treatment response evaluation to neoadjuvant chemotherapy: a prospective multicenter study (ACEBIB trial). Cancer Imaging. 2018 Aug 2;18(1):25. doi: 10.1186/s40644-018-0158-4.
Clinical trial NCT00258492: Restless Legs Syndrome Exercise Intervention
Official title: The Prevalence and Outcomes of Restless Legs Syndrome Among Veterans - Exercise Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Restless Legs Syndrome
Insomnia
Keywords: Restless legs syndrome
Insomnia
Daytime sleepiness
Exercise
Lead sponsor: Northeastern Ohio Universities College of Medicine
Sponsor class: OTHER
Collaborators: name: Louis Stokes VA Medical Center
name: The University of Akron
name: U.S. Army Medical Research and Development Command
name: Pfizer
First posted: 2005-11-24
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A pilot study of an aerobic exercise intervention to moderate symptoms and improve sleep quality among patients with Restless Legs Syndrome (RLS). We, the researchers at Northeastern Ohio Universities College of Medicine, hypothesize that, relative to a control group, RLS sufferers who participate in an aerobic exercise intervention will demonstrate:

1. reduced RLS symptoms;
2. improved sleep quality;
3. reduced daytime sleepiness.

Detailed description: We will implement an exercise intervention among persons who suffer from RLS.

Study members will be Veterans, over the age of 40, who have been identified as RLS cases as part of our larger study of "The Prevalence and Outcomes of Restless Legs Syndrome among Veterans." We will use a cross-over design in which Veterans will be randomly assigned to the exercise intervention or control. Each arm of the study will be 3 months duration.

The protocol for the intervention will consist of twice weekly supervised exercise sessions. The goal for exercise participants will be to engage in continuous aerobic exercise for 45 minutes at an intensity of approximately 60% of VO2max. The control will be weekly support group meetings.

Outcomes will be measured using standardized sleep scales, actigraphy, and daily sleep and exercise logs.

Eligibility criteria: Inclusion Criteria:

* Meets case definition for RLS with symptoms at least one day a week
* Age 40 and older
* Moderate or severe insomnia
* Able to engage in moderate exercise
* Permission of primary care physician to participate in exercise.

Exclusion Criteria:

* Serum ferritin below 50 ng/ml
* Body mass index (BMI) greater than 40
* History of recent myocardial infarction or stroke
* Alcohol use, more than 3 drinks a day
* Current use of medications for sleep

Primary outcomes:
measure: RLS symptom severity, measured bi-weekly
Secondary outcomes:
measure: Sleep efficiency, measured bi-weekly
measure: Insomnia severity, measured bi-weekly
measure: Day time sleepiness, measured bi-weekly
Other outcomes:
Locations:
Study officials:
affiliation: Northeastern Ohio Universities College of Medicine
name: Claire C. Bourguet, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02237092: Effect of Intra-abdominal Pressure to the Level of the Sensory Block at Caesarean Section Under Spinal Anesthesia
Official title: Effect of Intra-abdominal Pressure to the Level of the Sensory Block at Caesarean Section Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Anesthesia Problems
High-Risk Pregnancy
Lead sponsor: Tver Regional Perinatal Center
Sponsor class: OTHER
First posted: 2014-09-11
Enrollment: 196
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: It is known that an increase in intra-abdominal pressure (IAP) causes a decrease in the volume of cerebrospinal fluid in the lumbar and lower thoracic region, which may contribute to the development of more high spinal block.

Detailed description: There is a hypothesis, the higher the level of intra-abdominal pressure, the greater the likelihood of developing a high-level (=\>Th4) sensor block.

Eligibility criteria: Inclusion Criteria:

* Gestational age 36 - 40 weeks
* Singleton pregnancies
* Elective caesarean section

Exclusion Criteria:

* Gestational age \<= 35 weeks
* Twins pregnancies
* Disease the cardiovascular system (hypertension, etc.)
* Non-elective caesarean section

Primary outcomes:
measure: The Level of Intra-abdominal Pressure (IAP)
timeFrame: Before spinal anesthesia, average 10 minutes.
measure: Classification Grade of Intra-abdominal Hypertension (IAH)
timeFrame: Before spinal anesthesia, average 10 minutes.
measure: Obesity and IAP
timeFrame: Before spinal anesthesia, average 10 minutes.
Secondary outcomes:
measure: Level of Sensory Blocks
timeFrame: After spinal anesthesia, average 20 minutes.
measure: The Level of IAP
timeFrame: After spinal anesthesia, average 20 minutes.
measure: Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg
timeFrame: After spinal anesthesia, average 20 minutes.
Other outcomes:
Locations:
city: Tver
country: Russian Federation
facility: Tver Regional Perinatal Center
Study officials:
affiliation: Tver Regional Perinatal Center
name: Alexandr Ronenson, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Tver State Medical Academy
name: Sergei Sitkin, DMedSc
role: STUDY_DIRECTOR
References:
citation: S. Sitkin, A. Ronenson, J. Savelieva, M. Cherdyntsev. Prediction of high level spinal block in caesarean section. Regional Anesthesia and Pain Medicine. - 2012. - Volume 37. - Sup 1 5. - p. 183.
citation: Sitkin, S.; Ronenson, A.; Wagle, S.; Saveleva, J. Effect of intra-abdominal pressure of pregnancy for the development of spinal block for cesarean section: 11AP1-10. European Journal of Anaesthesiology. - 2013 - Volume 30. - Sup 51. - p. 167-168.
citation: Sitkin S., Ronenson A.M., Savelieva J.V., Wagle S. Influence of intra-abdominal pressure (iap) and body mass index (bmi) in pregnancy on the development of spinal block for cesarean section. Regional Anesthesia and Pain Medicine, Volume 38, Number 5, Supplement 1 5, September-October. - 2013. - p. 179