louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06565182: The Acute Effect of Physical Exercise in Pregnancy
Official title: The Acute Effect of Physical Exercise in Pregnancy on the Fetoplacental Unit: A Randomized Crossover Trial Comparing Aerobic Versus Resistance Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: blood flow
pregnancy
aerobic exercise
resistance exercise
doppler ultrasound
physical activity
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this crossover clinical trial is to investigate the acute physiological effect of exercise on the uterine and fetal blood flow in pregnancy. The main questions it aims to answer are:

* What is the acute physiological effect of exercise on the uterine and fetal blood flow in pregnancy?
* What is the acute physiological effect of continuous aerobic exercise versus resistance exercise on the uterine and fetal blood flow in pregnancy?
* What is the effect of physical activity levels on the uterine and fetal blood flow in pregnancy?

Researchers will compare the continuous aerobic exercise to the resistance exercise with a 3-6-week interval to examine the acute physiological effect on the uterine and fetal blood flow.

Participants will:

* Fill in a physical activity level questionnaire at baseline.
* Complete either continuous aerobic exercise or resistance exercise and take blood flow measurements.
* Complete the remaining type of exercise after a 3-6-week interval and take blood flow measurements.


Eligibility criteria: Inclusion Criteria:

* pregnant, over the age of 18 years, singleton pregnancy, both primigravidas and multigravidas, uncomplicated pregnancy and absence of contra-indications for exercise as per Canadian guidelines (Mottola et al. 2018).

Exclusion Criteria:

* smoking, substance abuse, chronic diseases, fetal growth restriction, fetal abnormalities, hypertension, history of premature delivery, vaginal hemorrhage, placenta previa, contractions before/during intervention, diabetes mellitus, preeclampsia and previous pregnancy complications.

Primary outcomes:
measure: Blood flow using doppler ultrasound measurements
timeFrame: The measurements were taken before and after each exercise bout. Participants rested for at least 15 minutes before their baseline measurement was evaluated. Reassessment was done within 15 minutes after the intervention.
Secondary outcomes:
measure: Physical activity levels
timeFrame: Physical activity levels were assessed at baseline.
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
Clinical trial NCT02671682: Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis
Official title: Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis and Clinically Isolated Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Clinically Isolated Syndrome
Keywords: Immunoadsorption
Plasmapheresis
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 61
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This observational study investigates the efficacy and safety of immunoadsorption versus plasmapheresis in 60 patients with relapse in Multiple Sclerosis and Clinically isolated syndrome who do not fully recover after a high doses of intravenous corticosteroids.


Eligibility criteria: Inclusion Criteria:

* relapse of Multiple Sclerosis or Clinically Isolated Syndrome (without complete remission after high dose steroid therapy)
* informed consent
* age ≥ 12 years old

Exclusion Criteria:

* clinical or laboratory signs of infection
* intake of Angiotensin Converting Enzyme Inhibitor within 1 week prior to first treatment

Primary outcomes:
measure: Multiple Sclerosis Functional Composite (MSFC)
timeFrame: 4 weeks
Secondary outcomes:
measure: Expanded Disability Status Scale (EDSS)
timeFrame: 2 and 4 weeks
measure: EuroQol (EQ5D-5L)
timeFrame: 2 and 4 weeks
measure: Response Rate
timeFrame: 4 weeks
measure: Vision
timeFrame: 4 weeks
measure: Visually Evoked Potentials (VEP; P100 latency)
timeFrame: 4 weeks
measure: Somatosensory Evoked Potentials (SEP; Medianus and Tibialis; N20-, P40-latency)
timeFrame: 4 weeks
measure: Thickness of Retinal Nerve Fiber Layer (RNFL) in Optical Coherence Tomography (OCT)
timeFrame: 4 weeks
measure: Verbaler Lern- und Merkfähigkeitstest (VLMT) score
timeFrame: 4 weeks
measure: MSFC
timeFrame: 2 weeks
measure: Thickness of Ganglion Cell Layer (GCL) in OCT
timeFrame: 4 weeks
measure: Symbol Digit Modalities Test (SDMT) score
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Department of Neurology, University of Ulm
state: Baden-Württemberg
Study officials:
References:
citation: Dorst J, Fangerau T, Taranu D, Eichele P, Dreyhaupt J, Michels S, Schuster J, Ludolph AC, Senel M, Tumani H. Safety and efficacy of immunoadsorption versus plasma exchange in steroid-refractory relapse of multiple sclerosis and clinically isolated syndrome: A randomised, parallel-group, controlled trial. EClinicalMedicine. 2019 Nov 14;16:98-106. doi: 10.1016/j.eclinm.2019.10.017. eCollection 2019 Nov.
Clinical trial NCT05456282: Acute Effects of AMPS on Cardiovascular, Functional Capacity and Postural Control in Patients With Parkinson's Disease
Official title: Acute Effects of Automated Mechanical Peripheral Stimulation on Cardiovascular, Functional Capacity and Postural Control in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Universidad Católica del Maule
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will randomly assigned to receive one of two alternative interventions (SHAM or AMPS) in the first session and the other intervention during the second visit. Participants will be assessed before and after each session.
Primary purpose: TREATMENT

Brief summary: Considering that Parkinson's Disease (PD) can significantly compromise functional mobility and cardiovascular system in patients with PD, therapies aimed at improving these aspects, mainly by non-pharmacological and non-invasive methods, are paramount. This clinical trial will study the acute effects of plantar stimulation using a therapy called automated peripheral mechanical stimulation (AMPS) on cardiovascular and functional mobility in patients with PD.

The hypothesis of this study is that one single session will be effective in improving, acutely, the cardiovascular system and functional capacity in patients with PD.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of idiopathic Parkinson's disease
* Scoring 1 to 3 on the Hoehn and Yhar scale
* Pharmacological treatment unchanged for at least 30 days prior the study

Exclusion Criteria:

* Signs of cognitive decline, based on the results of the Mini Mental State Examination
* Cardiorespiratory, neuromuscular and musculoskeletal diseases not related to PD
* Sensory peripheral neuropathy, diabetes or any other disease known to promote autonomic dysfunction

Primary outcomes:
measure: Timed up and go
timeFrame: 1 hour
measure: Center of Pressure
timeFrame: 1 hour
measure: Heart rate variability
timeFrame: 1 hour
Secondary outcomes:
measure: Tinetti Test
timeFrame: 1 hour
Other outcomes:
Locations:
city: Talca
country: Chile
facility: Universidad Católica del Maule - Campus San Miguel
state: Maule
Study officials:
affiliation: Universidad Católica del Maule
name: Antonio R Zamunér, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07024082: Water-based Liuzijue Exercise on Childhood-onset Systemic Lupus Erythematosus
Official title: Water-based Liuzijue Exercise on Childhood-onset Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Systemic Lupus Erthematosus
Keywords: Systemic lupus erythematosus
Water-based exercise
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 130
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Systemic lupus erythematosus (SLE) is a life-long systemic autoimmune disease with a large variability in its clinical course. The onset of SLE during childhood and adolescence represents 10 to 20% of all SLE cases \[1\] and is associated with a more severe disease course compared to adult SLE. Due to earlier diagnosis as well as significant advances in the management of childhood-onset SLE (C-SLE), mortality rates have greatly decreased, with an estimated 5- to 10-year survival rate of over 85% \[2\].As a consequence, there has been a great increase in long-term co-morbidities, particularly cardiovascular disease (CVD), which is currently considered a major cause of long-term mortality in C-SLE patients \[3\].

Detailed description: Systemic lupus erythematosus (SLE) is a life-long systemic autoimmune disease with a large variability in its clinical course. The onset of SLE during childhood and adolescence represents 10 to 20% of all SLE cases As a consequence, there has been a great increase in long-term co-morbidities, particularly cardiovascular disease (CVD), which is currently considered a major cause of long-term mortality in C-SLE patients. Liuzijue, which is one such traditional Chinese health exercise, is performed in expiration to produce six different sounds (xu, he, hu, si, chui, and xi) together with smooth movements of the upper and lower limbs .

Eligibility criteria: Inclusion Criteria:

* Age between 7 and 15 years
* Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K score ≤ 16

Exclusion Criteria:

* Neuropsychiatry involvement, hematologic abnormalitie
* cardiovascular rhythm and conduction disorders, musculoskeletal distur- bances that precluded participation in physical exercise
* pleuritis, pericarditis, endocarditis, acute kidney failure

Primary outcomes:
measure: Cardiorespiratory exercise test: Peak VO2 (mL/min
timeFrame: base line and 12 weeks
measure: Cardiorespiratory exercise test:Peak W (w) (working rate) (Watts)
timeFrame: base line and after 12 weeks
measure: Cardiorespiratory exercise test:Chronotropic reserve (CR) %
timeFrame: base line and after 12 weeks
Secondary outcomes:
measure: Functional exercise capacity
timeFrame: base line and after 12 weeks
measure: Bone mineral density
timeFrame: base line and after 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00317382: Does Static Ultrasound-Preview Reduce the Incidence of Difficult Lumbar Puncture?
Official title: Does Static Ultrasound-Preview Reduce the Incidence of Traumatic and/or Difficult Lumbar Puncture? A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Headache
Meningitis
Subarachnoid Hemorrhage
Keywords: lumbar puncture
headache
traumatic tap
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2006-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Does the use of ultrasound facilitate a lumbar puncture by reducing the number of difficult and traumatic lumbar punctures?

Detailed description: This is a controlled trial randomizing lumbar puncture patients to groups utilizing ultrasound to preview the bony structures of the spine versus using standard palpation technique. The goal is to determine the helpfulness of ultrasound in performing lumbar punctures (to reduce difficult and traumatic lumbar punctures) among patients whose spines cannot be easily visualized.

Eligibility criteria: Inclusion Criteria:

* Age greater than 18
* Clinical need for lumbar puncture
* Unable to visualize spine in position for the lumbar puncture

Exclusion Criteria:

* Able to visualize the spinous processes

Primary outcomes:
measure: 3 or more needle sticks to successfully complete lumbar puncture
timeFrame: We collect the data immediately
measure: Greater than 400 red blood cells in the cerebral spinal fluid
timeFrame: Data is obtained within 1 hour when the lab reports the results of the CSF analysis
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: St.Luke's-Roosevelt Hospital
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Kaushal Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05742282: ASPIRE (Aub-haS2 Plus bIomaRkErs)
Official title: Validation of the AUB-HAS2 Score in a Brazilian Population and Study of the Additional Impact of Biomarkers in Predicting Perioperative Risk
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Perioperative Medicine
Lead sponsor: Hospital Samaritano Paulista
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 2500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients ≥ 40 years, that will undergo non-cardiac procedures, with expected hospitalization for at least 24 hours postoperatively.

Brief summary: ASPIRE is a prospective, multicenter, observational study that will assess the performance of AUB-HAS2 to predict the occurrence of major adverse cardiovascular events 30-days after a non-cardiac surgery and the additional role of high-sensitivity troponin T and NT-ProBNP biomarkers in the accuracy of different event prediction indexes after non-cardiac procedures.

Detailed description: Primary objectives:

Primary objective of the validation arm: to analyze the accuracy of the AUB-HAS2 index in predicting the occurrence of myocardial infarction, stroke and death within 30 days after non-cardiac surgeries.

Primary objective biomarker arm: to analyze the additional role of high-sensitivity troponin T and NT-ProBNP biomarkers in the accuracy of different event prediction indexes after non-cardiac surgeries.

Secondary objectives:

To analyze the potentially preventable factors related to adverse outcomes after non-cardiac surgeries in order to offer subsidies for more assertive guidelines regarding the implementation of perioperative protection strategies. Compare the performance of these scores with others that have already been validated (ACP and Lee - see Annex A).

Eligibility criteria: Inclusion Criteria:

* Age ≥ 40 years, in the preoperative period of non-cardiac procedures, with expected hospitalization for at least 24 hours postoperatively.

Exclusion Criteria:

* Refusal to sign the informed consent form.

Primary outcomes:
measure: RATE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS
timeFrame: 30 days
Secondary outcomes:
measure: RATE OF MYOCARDIAL INJURY
timeFrame: 30 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Samaritano Paulista
Study officials:
References:
Clinical trial NCT06110182: Evaluation of the Advantage in the Use of Enteral Nutrition in Children Treated for Acute Lymphoblastic Leukemia
Official title: Evaluation of the Advantage in the Use of Enteral Nutrition in Children Treated for Acute Lymphoblastic Leukemia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Leukemia, Lymphoblastic
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children diagnosed with acute lymphoblastic leukemia between 2010 and 2021 in Nancy and Reims

Brief summary: This is a multicenter retrospective study (Reims and Nancy), with data collection over 12 years from 01/01/2010 to 12/31/2022 Patients included are children diagnosed with acute lymphoblastic leukemia between 2010 and 2021 in the 2 centers.

Patients will be categorized into 3 groups:

* No nutritional support
* Support by enteral nutrition
* Parenteral nutrition support Their nutritional status will be assessed at the end of induction, at 6 months and then at 12 months from diagnosis.

The main objective of this study is therefore to compare the nutritional status of children with acute lymphoblastic leukemia depending on whether they received enteral or parenteral nutritional support during their treatment.

The secondary objective is to evaluate the occurrence of complications during treatment according to the nutritional support received.


Eligibility criteria: Inclusion Criteria:

* Children between 1 and 18 years old diagnosed with Medium risk/ High Risk B acute lymphoblastic leukemia or Standard/ High Risk T acute lymphoblastic leukemia between 2010 and 2021 in Nancy and Reims.

Exclusion Criteria:

* Patients less than 1 year old
* leukémia with philadelphia chromosome
* standard risk B acute lymphoblastic leukemia
* bone marrow transplant during treatment
* death during the year following diagnosis
* refusal of the patient (parents) to participate in the study

Primary outcomes:
measure: Z-score
timeFrame: 6 months
Secondary outcomes:
measure: BMI
timeFrame: 6 months
measure: albumin
timeFrame: 6 months
measure: complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
Study officials:
References:
Clinical trial NCT00163982: Vasoactive Peptides in Portal Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Portal Hypertension
Keywords: HVPG > 12 mmHg
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2005-09-14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is looking at the detection of vasoactive peptides in portal hypertension.


Eligibility criteria: Inclusion Criteria:

* HVPG \>= 12 mmHg

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: William W Kemp, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00413582: Pain Management for Pectus Excavatum Repair
Official title: Prospective Randomized Trial: Pain Management Strategy After Pectus Excavatum Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Pectus Excavatum
Bar Repair
Pain Control
Pectus Excavatum Repair
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2006-12-20
Enrollment: 110
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to scientifically evaluate two different management strategies for post-operative pain after pectus excavatum repair.

The hypothesis is that pain management without an epidural decreases hospital stay without compromising comfort.

The primary outcome variable is length of hospitalization after the intervention.

Detailed description: This will be a single institution, prospective, randomized clinical trial involving patients who undergo the minimally invasive repair of a pectus excavatum deformity with bar placement. This is intended to be a definitive study.

Power calculations based on the known length of hospitalization listed above with α = 0.05 and power of 0.8 show the need for 55 patients in each arm. The primary end point will be reached during the hospital stay; therefore, we expect a very small amount of attrition and will intend to recruit 110. One group will undergo an attempt for epidural regional analgesia (epidural) for post-operative pain control. The other groups will receive patient controlled intravenous systemic analgesia (PCA).

Both groups will have the same management algorithm. All data will be analyzed on intention-to-treat basis.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing a pectus excavatum repair with bar placement.

Exclusion Criteria:

* Open repair
* Re-Do operation
* Known allergy to a pain medication in the protocol
* Existing contraindications to epidural catheter placement
* Requirement for 2 bars to be placed (rare)
* Inadequate baseline cognitive function to understand/respond to VAS questionnaire

Primary outcomes:
measure: Length of Hospitalization
timeFrame: 1 week
Secondary outcomes:
measure: Time in the Operating Room
timeFrame: 1 week
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Shawn D St. Peter, MD
role: PRINCIPAL_INVESTIGATOR
References: