louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05479539: Action Observation Therapy in Patients Undetgoing Surgery for Shoulder Instability
Official title: Effects of Action Observation Therapy in Patients Undergoing Surgery for Shoulder-instability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Instability
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 40
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 will aim at investigating the effects of action observation therapy (action observation plus motor imagery) in patients with shoulder instability undergoing capsulo-plastic surgery. Forty subjects scheduled for capsulo-plastic surgery will be randomized into an AOT or Control group. AOT group will undergo action observation followed by motor imagery of upper limb motor tasks for 4 weeks after surgery, whereas Control group will perform no intervention. In addition, both groups will undergo postoperative usual care including immobilization with a brace and passive upper limb mobilization. All participants will be assessed for shoulder pain, function, range of motion, fear of movement and quality of life the day before surgery, at training end and 3 months after training end.


Eligibility criteria: Inclusion Criteria:

* Subjects undergoing capsule-plastic surgery or Latarjet stabilization for shoulder instability

Exclusion Criteria:

* Previous upper limb surgery
* Cognitive impairments
* Visual or auditory impairments
* Postoperative complications limiting upper limb motor recovery (e.g., infections)

Primary outcomes:
measure: Changes in shoulder function
timeFrame: At baseline, after 4 weeks of training and at 3 month after the training end
measure: Changes in shoulder function
timeFrame: At baseline, after 4 weeks of training and at 3 month after the training end
Secondary outcomes:
measure: Changes in shoulder pain
timeFrame: At baseline, after 4 weeks of training and at 3 month after the training end
measure: Changes in shoulder range of motion
timeFrame: At baseline, after 4 weeks of training and at 3 month after the training end
measure: Changes in fear of movement
timeFrame: At baseline, after 4 weeks of training and at 3 month after the training end
measure: Changes in quality of life
timeFrame: At baseline, after 4 weeks of training and at 3 month after the training end
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02718339: In-patient Asthma Counseling by Pulmonologist and Hospital Re-admission Rate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Prospective randomized clinical trial to assess the effect of in-hospital intensive counseling and follow-up vs. usual care, on re-admission rates of patients with Asthma.

The study population will include asthma patients admitted to internal Medicine departments and medical ICU at Soroka University Medical Center, due to asthma exacerbation.


Eligibility criteria: Inclusion Criteria:

1. Males and females ≥ 18 years old.
2. Admitted to Internal Medicine at Soroka University Medical Center due to asthma exacerbation.

Exclusion Criteria:

1. Substance abuse (except for tobacco).
2. Handicapped or bed ridden patients.
3. Patients who don't speak Hebrew, English, Russian or Arabic.
4. Other significant respiratory disease such as COPD, interstitial lung disease (as decided by the PI).

Primary outcomes:
measure: Re-admission rate
timeFrame: Within 6 months after discharge
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05882539: Oral Mucosal Pressure Injury in ICU Patients With Oral Tracheal Intubation
Official title: Construction of Risk Prediction Model for Oral Mucosal Pressure Injury in ICU Patients With Oral Tracheal Intubation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Mucosal Pressure Injury
Keywords: Intensive Care Units
Intubation, Intratracheal
Mucosal Pressure Injury
Prediction Model
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 471
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: ICU patient with tracheal intubation inserted through the mouth

Brief summary: In this study, based on the conceptual framework of Pressure Injurie development, the risk factors for pressure injury in critically ill patients provided by the latest guidelines, and combined with the current relevant studies on mucosal pressure injury, we prospectively observed and collected clinical data related to tracheal intubation patients in the ICU, analyzed the risk factors for the occurrence of oral MPI, and established a risk prediction model to help clinical and nursing staff to detect and actively prevent oral MPI at an early stage The study aims to improve the quality of nursing management, enhance the level of nursing services and improve patient satisfaction.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years;
2. Duration of ICU admission ≥ 48h.

Exclusion Criteria:

1. radiotherapy oral mucositis;
2. Pressure injury to the mucosa, oral ulcers and erosions from other causes already present prior to tracheal intubation;
3. Patients undergoing oral surgery;
4. those who have been brought in from outside the hospital for \>48h for transoral tracheal intubation;
5. Common oral ulcers (not pressure/friction generated).

Primary outcomes:
measure: oral mucosal pressure injury
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Zhu Yi Rong
role: STUDY_DIRECTOR
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Sun Yan
role: PRINCIPAL_INVESTIGATOR
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Xiang Yan
role: PRINCIPAL_INVESTIGATOR
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Guo Jingjing
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01056939: Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients
Official title: Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilation
Keywords: Ventilatory care, children, intensive care, NAVA
Children needing ventilatory care
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2010-01-26
Enrollment: 170
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if NAVA-technology is better in detecting patients own inspiratory efforts during mechanical ventilation than currently used flow-triggering in PRVC (pressure regulated volume controlled) ventilation, and if NAVA gives real benefits for patients or not.

The investigators study hypothesis is that NAVA-technology can detect spontaneous inspiration more accurately than currently used methods, and thus will lead to more smooth adaptation to mechanical ventilation in pediatric patients. The investigators expect this to decrease the time of ventilatory support needed.

Detailed description: Asynchrony means that the timing of support given by ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications, make the weaning more difficult and may affect the survival rates.

In our study we randomly treat pediatric patients needing ventilatory support with neurally adjusted ventilatory assist and pressure controlled or PRVC-ventilation. We are willing to find out if there are any special benefits for patients with each treatment mode.

Eligibility criteria: Inclusion Criteria:

* All children from term newborn (37+0 gestational week) to 16-year-old needing ventilatory care at least 30 minutes

Exclusion Criteria:

* Any condition that prevents feeding tube positioning. Critical ventilatory or perfusion problems.

Primary outcomes:
measure: Primary outcome is the duration of mechanical ventilation
timeFrame: 30minutes-3weeks
Secondary outcomes:
measure: Amount of sedative medication needed
timeFrame: 30minutes-3weeks
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: University Hospital of Oulu
Study officials:
References:
Clinical trial NCT02567539: Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma
Official title: Phase II Study of Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent High Grade Glioma
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is aimed to evaluate efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.

Detailed description: Investigators designed this study of a re-irradiation with single radiosurgery or hypofractionated intensity modulated radiation therapy (IMRT) with or without temozolomide.

Objective of the study is evaluating efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Karnosky performance status (KPS) ≥70
* Patients aged \>70 years with KPS ≥80
* Histopathologically confirmed grade III-IV glioma
* Estimated survival ≥ 3 months
* Any Tumor volume
* Unifocal tumor
* Interval time from previous radiotherapy ≥ 6mesi
* Normal liver, Kidney and bone marrow function
* Written informed consent

Exclusion Criteria:

* KPS \< 70
* Multifocal tumor
* Other primary cancer
* Pregnant women

Primary outcomes:
measure: Progression free of participants
timeFrame: 4 years
measure: Overall survival of participants
timeFrame: 4 years
Secondary outcomes:
measure: Incidence of radionecrosis
timeFrame: 3 months
measure: Questionnaire assessment of neurocognitive function
timeFrame: 6 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
Study officials:
affiliation: Istituto Clinico Humanitas
name: Piera Navarria, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Navarria P, Ascolese AM, Tomatis S, Reggiori G, Clerici E, Villa E, Maggi G, Bello L, Pessina F, Cozzi L, Scorsetti M. Hypofractionated Stereotactic Radiation Therapy in Recurrent High-Grade Glioma: A New Challenge. Cancer Res Treat. 2016 Jan;48(1):37-44. doi: 10.4143/crt.2014.259. Epub 2015 Feb 23.
citation: Scorsetti M, Navarria P, Pessina F, Ascolese AM, D'Agostino G, Tomatis S, De Rose F, Villa E, Maggi G, Simonelli M, Clerici E, Soffietti R, Santoro A, Cozzi L, Bello L. Multimodality therapy approaches, local and systemic treatment, compared with chemotherapy alone in recurrent glioblastoma. BMC Cancer. 2015 Jun 30;15:486. doi: 10.1186/s12885-015-1488-2.
citation: Navarria P, Pessina F, Clerici E, Bellu L, Franzese C, Franzini A, Simonelli M, Bello L, Santoro A, Politi LS, D'agostino GR, Casarotti A, Fernandes B, Torri V, Scorsetti M. Re-irradiation for recurrent high grade glioma (HGG) patients: Results of a single arm prospective phase 2 study. Radiother Oncol. 2022 Feb;167:89-96. doi: 10.1016/j.radonc.2021.12.019. Epub 2021 Dec 22.
Clinical trial NCT01547039: Platelet Reactivity and MES During CEA
Official title: Platelet Reactivity Testing in Association With Perioperative Microembolic Signals During Carotid Endarterectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Artery Stenosis
Ischemic Stroke
Myocardial Infarction
Aspirin Resistance
Keywords: Carotid endarterectomy
Transcranial doppler
Micro embolic signals
Platelets
Aspirin
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing elective carotid endarterectomy in University Medical Centre Utrecht

Brief summary: The purpose of this study is to analyze the association between aspirin efficacy and general platelet reactivity in relation to microembolic signals (MES) during carotid endarterectomy (CEA).


Eligibility criteria: Inclusion Criteria:

* Al patients undergoing elective carotid endarterectomy

Exclusion Criteria:

* Patients requiring a blood transfusion prior to surgery
* Patients with an inappropriate temporal bone window for transcranial Doppler (TCD)
* Patients on vitamin K antagonists or antiplatelet treatment other then aspirin
* Patients with an artificial cardiac valve

Primary outcomes:
measure: Microembolic signals (MES)
timeFrame: During and 1 hour following carotid endarterectomy (CEA)
Secondary outcomes:
measure: Ischemic stroke
timeFrame: within 30 days postoperative
measure: Asymptomatic perioperative myocardial injury
timeFrame: 3 days postoperative
measure: Myocardial infarction
timeFrame: Within 30 days postoperative
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Gert Jan de Borst, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01575639: Prednisolone in Infantile Spasms- High Dose Versus Usual Dose
Official title: Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infantile Spasms
West Syndrome
Lead sponsor: Lady Hardinge Medical College
Sponsor class: OTHER_GOV
First posted: 2012-04-11
Enrollment: 63
Sex: ALL
Minimum age (years): 3
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Infantile spasms comprise a difficult to treat type of epilepsy in young children. Hormonal treatment, i.e. Prednisolone and ACTH are considered the treatment of choice. There is no consensus on the dosage of Prednisolone required for the treatment of infantile spasms. Recent data has shown that a high dose (4 mg/kg/day) may be more efficacious than the usual dose (2 mg/kg/day). However, there are no randomized controlled trials comparing these doses. A higher steroid dose may also be associated with more side effects. Therefore, this study was planned to compare the efficacy and tolerability of the high dose versus the usual dose in children with infantile spasms, in a randomized open-label trial design


Eligibility criteria: Inclusion Criteria:

- Children aged 3 months to 2 years presenting with epileptic spasms (at least 1 cluster/day) with EEG evidence of hypsarrhythmia or its variants

Exclusion Criteria:

1. Children with active systemic illness
2. Children with evidence of active tuberculosis
3. Severe Acute Malnutrition ad defined by WHO (visible wasting/Mid Upper Arm Circumference \< 11 cm/pedal edema/Weight for height \< 3 SD)
4. Children with recurrent illness/chronic systemic illness

Primary outcomes:
measure: Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 .
timeFrame: 14 days
Secondary outcomes:
measure: Proportion of children with adverse effects
timeFrame: 14 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
state: Delhi
Study officials:
affiliation: Lady Hardinge Medical College
name: Satinder Aneja, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chellamuthu P, Sharma S, Jain P, Kaushik JS, Seth A, Aneja S. High dose (4 mg/kg/day) versus usual dose (2 mg/kg/day) oral prednisolone for treatment of infantile spasms: an open-label, randomized controlled trial. Epilepsy Res. 2014 Oct;108(8):1378-84. doi: 10.1016/j.eplepsyres.2014.06.019. Epub 2014 Jul 5.
Clinical trial NCT00964639: Postoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral Osteotomies
Official title: Postoperative Pain in Children With Cerebral Palsy After Pelvic and Femoral Osteotomies. A Prospective, Randomized and Double-blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Cerebral Palsy
Keywords: Pain
Postoperative
Local infiltration analgesia
Cerebral palsy
r-FLACC
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-08-25
Enrollment: 12
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a comparison of postoperative pain in children with cerebral palsy after surgery on the hip or femur. One group is treated with p.o. (by mouth) or intravenous (i.v.) analgesia, and the other group is treated with local infiltration analgesia with Naropine.

Pain is measured with r-FLACC, a pain-score validated for children with cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* Age under 18
* informed consent
* Postoperative cast with spica

Exclusion Criteria:

* Previous surgery in the same hip
* Other surgical procedure planned at the same time
* Bilateral surgery
* Previous allergic reaction to local analgesia

Primary outcomes:
measure: Difference in pain measured with r-FLACC between the 2 groups
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Departement of childrens orthopaedics, Aarhus University Hospital
Study officials:
References:
Clinical trial NCT02814539: Brain Function in Children With Congenital Heart Disease (CHD)
Official title: Brain Network Function in School-age Children With Congenital Heart Disease and Its Relation to Higher Order Cognitive Functions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2016-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The purpose of the study is to determine whether the neurodevelopmental outcome and in particular executive functions in 9 to 14 year old school children with congenital heart disease who underwent cardiopulmonary bypass surgery during their first three months of life is impaired in comparison to healthy children at same age. Executive functions are higher order cognitive functions and critical for school success.


Eligibility criteria: Inclusion Criteria:

* Congenital heart disease,
* Cardiopulmonary bypass surgery during first three months of life,
* No genetic syndrome,
* Gestational age \> 37 weeks of gestation.

Exclusion Criteria:

* Heart surgery without cardiopulmonary bypass,
* Heart surgery not within first three months of life,
* Born \<37 weeks of gestation,
* Any genetic syndrome detected.

Primary outcomes:
measure: Executive Functions, assessed with D-KEFS
timeFrame: 2 years
Secondary outcomes:
measure: slow wave activity on EEG
timeFrame: 2 years
measure: MRI volumetry
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: University Childrens Hospital Zurich
name: Bea Latal, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00224939: Pre-ESRD Syndrome in High Risk African Americans
Official title: Pre-ESRD Syndrome in High Risk African American Young Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2005-09-23
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluation of the dipping status of blood pressure (wether blood pressure decreases at night) and renal functional reserve and wether non-dippers (those whose blood pressure does not decrease at night) can be modulated to dippers with potassium treatment.

Detailed description: Evaluation of the dipping status of blood pressure (wether blood pressure decreases at night) and renal functional reserve and wether non-dippers (those whose blood pressure does not decrease at night) can be modulated to dippers with potassium treatment.

Eligibility criteria: Inclusion Criteria: 18-35, healthy volunteers, African American

Exclusion Criteria: Active medical conditions, prescription drug therapy other than birth control

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Elizabeth B Ripley, MD
role: PRINCIPAL_INVESTIGATOR
References: