louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06805838: Prolonged Manual Ventilation Simulation
Official title: Prolonged Manual Ventilation Simulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Manual Ventilation
Keywords: Prolonged manual ventilation simulation
BVM
Sotair
BLS certification
tidal volume
peak inspiratory pressure
Lead sponsor: SafeBVM
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2025-02-03
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A pilot study on simulated lung scenarios using the standard manual resuscitator bag, flow limiting resuscitator bag, and an FDA approved flow rate limiting device paired with a standard manual resuscitator.


Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* Have a current basic life support (BLS) certification
* Be available for the entire 10 hours to complete the protocol

Exclusion Criteria:

* Any training in medical school or respiratory therapy school
* Not being available for the full 10 hours to complete the protocol

Primary outcomes:
measure: Minute ventilation while manually ventilating the simulated lung
timeFrame: 10 hours of manual ventilation
measure: Minute ventilation while manually ventilating the simulated lung
timeFrame: 10 hours of manual ventilation
Secondary outcomes:
measure: Secondary Outcome Measure
timeFrame: 10 hours of manual ventilation
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown Physicians, Inc
state: Rhode Island
Study officials:
affiliation: Brown Physicians, Inc.
name: Mark Brady, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00884338: Cognitive Function After Stem Cell Transplantation
Official title: Evaluation of the Cognitive Function of Patients After Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fatigue
Cognitive Impairment
Stem Cell Transplantation
Keywords: Fatigue
Cancer
Cognitive impairment
Exercise
Sport
Peripheral blood stem cell transplantation
High-dose chemotherapy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2009-04-20
Enrollment: 60
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: The trial will evaluate the effects of an exercise program on the physical and cognitive performance of patients with hematological neoplastic diseases after high dose chemotherapy with stem cell support.

Detailed description: Patients (n = 60) will be randomized to an exercise or a control group. The randomization will be stratified for allogeneic or autologous blood stem cell transplantation. Patients in the exercise group will carry out an endurance training consisting of walking on a treadmill at a speed corresponding to 80% of the maximum heart rate. The exercise program will be carried out 3 times weekly for 8 weeks. Patients in the control group will receive counseling about exercise and behavioural techniques to reduce fatigue, but they will not participate at a structured exercise program. Physical performance (VO2max), cognitive function, mood and quality of life will be evaluated at recruitment and after 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Age 18 - 70
* Hematological neoplastic disease
* Treatment with high-dose chemotherapy with peripheral blood stem cell transplantation in the previous 3 years
* Karnofsky-Index \> 80%
* Ability to understand German

Exclusion Criteria:

* Cardiorespiratory, metabolic, inflammatory or osteoarticular diseases which can be aggravated by exercise
* Psychosis
* Organic brain damage
* Dementia
* PBSCT in the previous 6 weeks
* Pathological stress test at admission

Primary outcomes:
measure: VO2max
timeFrame: Recruitment and after 8 weeks
Secondary outcomes:
measure: Cognitive status, mood, quality of life
timeFrame: At recruitment and after 8 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Fernando Dimeo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06909838: Radial Shockwave for Spasticity in Children With CP or ABI
Official title: Radial Shockwave Therapy With ShockMaster 300® to Reduce Spasticity in Children With CP or Acquired Brain Injury: a Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spasticity Due to Cerebral Palsy
Spasticity Post-Traumatic Brain Injury
Keywords: Extracorporeal shockwave therapy
shockwave therapy
shock wave therapy
children
radial shockwave therapy
Lead sponsor: Gymna Uniphy
Sponsor class: INDUSTRY
Collaborators: name: FRAME Jessa Ziekenhuis, Belgium
First posted: 2025-04-04
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine if radial Extracorporeal shockwave therapy (rESWT) reduces spasticity in children with Cerbral Palsy (CP) or traumatic brain injury (TBI). The main questions it aims to answer are:

* Is it feasible to implement radial shockwave therapy in conventional physiotherapy plan in children with CP or TBI?
* Is it safe and effective to use rESWT for reducing spasticity in children with CP or TBI? Participants will receive a 4 week therapy intervention, as add on to the conventional physio (usual care), including one rESWT session per week for a total of 4 sessions.


Eligibility criteria: Inclusion Criteria:

* cerebral palsy or acquired brain injury
* between 6-18 years old;
* gross motor function classification ≥2;
* experiencing spasticity in the lower limb (calf muscles, hip adductor muscles or hamstring muscles) and/or in the upper limb (biceps muscle, wrist flexor muscles, finger flexor muscles) with Modified Ashworth Scores (MAS) ≥1+.

Exclusion Criteria:

* recent (≤3 months) Botox injections or other recent (≤6 months) invasive intervention;
* local infections or wounds; neuropathy;
* severe organ dysfunction;
* severe psychosocial dysfunction that would not allow adhering to protocol;
* planned changes in medication dosage or medication scheme that might affect spasticity during a 4-month intervention and follow-up phase.

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: Change from baseline to the end of intervention sessions at week 4
measure: Modified Ashworth Scale
timeFrame: Change from baseline to 3 months follow-up
Secondary outcomes:
measure: Patient Specific Functional Scale
timeFrame: Change from baseline to the end of intervention sessions at week 4
measure: Patient Specific Functional Scale
timeFrame: Change from baseline to 3 months follow-up
measure: passive Range Of Motion
timeFrame: Change from baseline to the end of intervention sessions at week 4
measure: passive Range Of Motion
timeFrame: Change from baseline to 3 months follow-up
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Sint-Gerardus
state: Limburg
Study officials:
affiliation: MFC Sint Gerardus
name: Peter Aerssens, Pediatrician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03850938: Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures
Official title: Comparison of Kyphoplasty With and Without Rotary Cutter Subacute Osteoporotic Vertebral Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spine Fracture
Keywords: fractures, compression
back pain
bone cements
kyphoplasty
Lead sponsor: Jinan Military General Hospital
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Kyphoplasty(PKP) is performed under general anaesthesia in patients with osteoporotic vertebral compression fracture. The balloon is first placed into the fractured vertebra and inflated with contrast agent for height restoration. Then, the cement is injected into the cavity created by the balloon. As the diffusion of cement can be interfered by closely barriers formed by surrounding cancellous bones, refractures are often found in patients with conventional PKP. Furthermore, the loss of restored height of surgical vertebrae due to refracture in PKP. The investigators will applied a rotary cutter to destroy the structure of the cavity created by the balloon. Finally, the cement is injected, which may effectively interdigitates with the surrounding cancellous bone.


Eligibility criteria: Inclusion Criteria:

1. Patient is able to undergo the vertebroplasty or balloon kyphoplasty procedure
2. Patient has read and sign the informed consent
3. Male or female, 50 years or older
4. Compressive and burst vertebral body fractures without any neurological deficit.
5. Persistent pain despite medical treatment according to VAS ≥ 5 or a last resort to morphine treatment

Exclusion Criteria:

1. Neurological signs related to the vertebral fracture to treat
2. Unmanageable bleeding disorder
3. History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.
4. Known allergy to bone cement
5. Local or generalized infection
6. Improvement of the symptoms of the patient with conservative management

Primary outcomes:
measure: Back pain: Visual analogue scales system
timeFrame: up to 2 years
Secondary outcomes:
measure: Refracture
timeFrame: up to 2 years
measure: Kyphotic angle and global thoracic and lumbar angulations
timeFrame: up to 2 years
measure: The patterns of cement opacification
timeFrame: during the procedure of PKP
measure: Height of the treated vertebral body
timeFrame: Preoperative, up to 2 years
measure: Medico-economic follow-up
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Min Li
state: Shandong
Study officials:
References:
Clinical trial NCT03063138: Evaluation of 3D Imaging Ulcer Camera
Official title: Evaluation of Three-dimensional Measurements of Wounds Using a Newly Developed 3D Camera
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Diabetic Foot Ulcer
Wound
Chronic Disease
Keywords: Diabetic foot ulcer
Measurement
Wound healing
Measurement device
Three-dimensional measurements
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with wounds from University Centre for Wound Healing, Odense University Hospital.

Brief summary: The aim of the study is to evaluate the intra- and inter-rater variability of wound measurements using the 3D camera and to compare with standard measurement methods (2D image method and gel injection). Forty-eight patients with wounds of various sizes are measured by four clinicians. Each wound is measured twice with the 3D camera, once by 2D image method and once by gel injection into wound cavity by two clinicians.

Detailed description: Diabetic foot ulcers constitute an increasing health problem in Denmark concurrent with an ageing population and an increase in diabetes prevalence. Diabetic foot ulcers belong to the most serious and costly complications. Several studies have found that the size and depth of the wound is one of the major etiologic factors for delayed healing. Wound measurement is important in monitoring the healing process of wound and in evaluating the effect of treatment. Three-dimensional methods for measuring wound size have made it possible to evaluate the process of wound healing with respect to all dimensions. The investigators have developed a 3D camera, which is able to measure wound size (2D area, 3D area, perimeter and volume) and to assess wound characteristics.

The aim of the study is to evaluate the intra- and inter-rater variability of wound measurements using the 3D camera and to compare with standard measurement methods (2D image method and gel injection). Forty-eight patients with wounds of various sizes are measured by four clinicians. Each wound is measured twice with the 3D camera, once by 2D image method and once by gel injection into wound cavity by two clinicians.

Eligibility criteria: Inclusion Criteria:

* Patients with wounds
* 18 years or older

Exclusion Criteria:

* Superficial ulcer (less than 5x5 mm with no substantial loss of subcutaneous tissue)
* Non-compliance (dementia, mental disorders)

Primary outcomes:
measure: Wound 2D area
timeFrame: 1 day
measure: Wound 3D area
timeFrame: 1 day
measure: Wound perimeter
timeFrame: 1 day
measure: Wound volume
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University Centre of Wound Healing, Odense University Hospital (OUH)
Study officials:
affiliation: Odense University Hospital
name: Knud Yderstræde, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00192738: Does Telephone Follow-up Improve Patients Satisfaction
Official title: Does Telephone Follow-up After Discharge Improve Patients Satisfaction and Decrease Hospitalization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Angina Pectoris
Pneumonia
Urinary Tract Infection
Keywords: telephone,
internal medicine,
readmission,
patients' satisfaction
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Several studies have shown the importance of Telephone follow-up in reducing hospital readmissions for heart failure. Therefore, we aimed in this cohort to investigate whether telephone follow-up with patients discharged from the general internal department improves patients' satisfaction, increases compliance to treatment and reduces adverse effects. Patients are recruited from the department of general internal medicine who gave informed consent and could communicate. Patients are interviewed by during hospital stay, one and three months later. This group will be compared with patients that are not interviewd by phone aftert hospital discharge.


Eligibility criteria: Inclusion Criteria: Ability to sign informed consent and communicate by phone in Hebrew, Arabic, Russian or English -

Exclusion Criteria:Non of the above

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Medical Center, Ruth & Bruce Rappaport Faculty of Medicine, Technion
name: Zaher S. Azzam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Medical Center, Ruth & Bruce Rappaport Faculty of Medicine
name: Zaher S Azzam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01313338: Experience in Predicting Decision Making for Receiving Treatment in Acute Coronary Syndrome Patients
Official title: Cognitive Representation, Emotional Responses and Hospitalization Experience in Predicting Decision Making for Receiving Treatment Among Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-03-11
Enrollment: 132
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: Acute coronary syndrome patients

Brief summary: The purpose of this study is to examine the predictability of cognitive representation, emotional responses, and hospitalization experience toward the decision to receive treatment of the acute coronary syndrome patients.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute coronary syndrome
* Patients who had first experience or recurrent acute coronary syndrome

Exclusion Criteria:

* Still have chest pain within 24 hours ago
* Cognition or communication disorder or having psychotic or neurologic symptoms

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Mahidol Univesity
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Pimpa Thepphawan, M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02848638: Pair Production PET Imaging to Detect Particle Distribution in Patients Undergoing Yttrium-90 Radioembolization
Official title: Pair Production PET Imaging to Detect Particle Distribution in Patients Undergoing Yttrium-90 Radioembolization With Large Hepatocellular Carcinomas or Associated Portal Vein Thrombosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Keywords: PET, Yttrium-90
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (18-85 years old), who have hepatocellular carcinoma with tumors that are greater than 5 cm or have tumor-associated portal vein thrombosis. The patients are currently undergoing treatment with Yttrium-90 Radioembolization, as part of their clinical care.

Brief summary: The primary goal of the study is to see if the PET/CT will be able to determine the precise location of the Y-90 particles within the liver and within the tumors. We hope to use this information in order to see if these particles distribute evenly throughout large tumors or if the particles go into the tumor which is located in the portal vein.

The secondary goals are threefold. First correlate the distribution of Y90 particles (as demonstrated by PET/CT) with the degree of dead-tumor tissue. Second, see if there is a difference in the Y90 particle's distribution when a low particle load (1-3 million particles) is used compared to when a high particle load (6-8 million particles) is used. Lastly, compare the sensitivity of standard imaging ( bremsstrahlung imaging) currently being used for the Yttrium-90 angioembolization procedure to the sensitivity of the pair production PET research imaging.


Eligibility criteria: Inclusion Criteria:

1. UWMC patients over 18 years of age
2. Presence of hepatocellular carcinoma greater than 5 cm OR presence of tumor-associated portal vein thrombosis.
3. Currently undergoing treatment with Yttrium-90 Radioembolization
4. Able to sign informed consent

Exclusion Criteria:

1. Patients who are not undergoing treatment with Yttrium-90 Radioembolization
2. Patients unable to provide informed consent

Primary outcomes:
measure: Degree and distribution of Y90 particle uptake
timeFrame: Within one year of Enrollment completion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chan KT, Alessio AM, Johnson GE, Vaidya S, Kwan SW, Monsky W, Wilson AE, Lewis DH, Padia SA. Hepatotoxic Dose Thresholds by Positron-Emission Tomography After Yttrium-90 Radioembolization of Liver Tumors: A Prospective Single-Arm Observational Study. Cardiovasc Intervent Radiol. 2018 Sep;41(9):1363-1372. doi: 10.1007/s00270-018-1949-5. Epub 2018 Apr 12.
Clinical trial NCT04268238: Pain Control in Dentin Hypersensitivity in Patients With MIH
Official title: Pain Control in Dentin Hypersensitivity in Patients With MIH: Study Protocol for a Randomized, Controlled, Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hypersensitivity Dentin
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effectiveness of different protocols in controlling dentin hypersensitivity in patients with teeth affected by MIH. The subjects will be randomly designated in four experimental groups, according to different treatments. Pain will be assessed with the visual analog scale (Visual Analogue Scale - VAS), after stimulation with air from the triple syringe and and an exploratory probe at the time of (initial) recruitment, immediately after treatment, after 1 week and 1 month, 3 and 6 months after treatment.


Eligibility criteria: Inclusion Criteria:

* Be between 18 and 35 years old;
* Present good general health;
* Present at least one tooth with dentin hypersensitivity reported in the cervical region, which must have a graduated sensitivity equal to or greater than 4 in the VAS scale.

Exclusion Criteria:

* Present active caries lesions or restoration defects in the tooth to be analyzed;
* Present sufficient dentin loss that requires restorative treatment or periodontal surgery;
* Volunteers who underwent any professional desensitizer treatment in the last 6 months;
* Volunteers who used desensitizing pastes in the 3 months;
* Volunteers who were using anti-inflammatory or analgesic drugs at the time of recruitment;
* Volunteers who are pregnant or breastfeeding.

Primary outcomes:
measure: Change in Pain Evaluated by a Visual Analog Scale (VAS)
timeFrame: Baseline, immediately after treatment, 1 week, 1, 3 and 6 months after treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: