louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01737021: Improving Outcomes After PICU Admission: A Pilot Study
Official title: A Psycho-educational Intervention to Improve Family Mental Health and Child Educational Outcomes Following Admission to PICU: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: PICU
Critical illness
Outcomes
Mental health
Education
Randomized Controlled Trial (RCT)
Pilot
Feasibility
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Children of St Mary's Intensive Care
First posted: 2012-11-29
Enrollment: 31
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 1. Evaluate the feasibility and acceptability of an information based intervention delivered to parents following their child's admission to paediatric intensive care;
2. Evaluate the feasibility and acceptability of the study design and procedures;
3. Explore the effects of the intervention on parent and child psychological outcomes 3-6 months post discharge from PICU;
4. Explore the effects of parental stress experienced during PICU admission on the effectiveness of the intervention;
5. To provide data that, combined with results from other studies, could inform the sample size for a future multi-site RCT.

Detailed description: Most children are now expected to make a complete medical recovery following admission to PICU. However, research suggests that some children will go on to develop psychological difficulties, such as problems with emotions, behaviour, and learning. In addition, parents themselves may suffer with emotional difficulties. Although the follow-up of survivors is recommended, there are currently no specific guidelines in place. Intervention in the early stages of recovery could help families pull through without long lasting after-effects.

Eligibility criteria: Inclusion Criteria:

* Unplanned emergency admissions to PICU for at least 12 hours
* Parent or primary carer speaks and can read English

Exclusion Criteria:

* Child dies whilst on ward
* Child discharged with a terminal illness
* Child has had multiple PICU admission in the past
* Staff feel it is inappropriate to approach family
* Family live overseas

Primary outcomes:
measure: The Number of Feasibility Criteria Successfully Met
timeFrame: 3-6 months post discharge from PICU
Secondary outcomes:
measure: Impact of Events Scale (IES)
timeFrame: 3-6 months post discharge from PICU
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3-6 months post discharge from PICU
Other outcomes:
Locations:
Study officials:
affiliation: Imperial College London
name: Elena Garralda, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Als LC, Nadel S, Cooper M, Vickers B, Garralda ME. A supported psychoeducational intervention to improve family mental health following discharge from paediatric intensive care: feasibility and pilot randomised controlled trial. BMJ Open. 2015 Dec 29;5(12):e009581. doi: 10.1136/bmjopen-2015-009581.
Clinical trial NCT00034684: Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia (Study P00701)
Official title: Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leukemia
Myelodysplastic Syndromes
Leukemia, Myeloid, Chronic
Blast Crisis
Leukemia, Lymphocytic
Keywords: Leukemia
Myelodysplastic Syndromes
Leukemia, Myeloid
Leukemia, Lymphocytic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-05-02
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase Inhibitor (SCH 66336) as a single agent in patients with Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia in Blast Crisis, or Acute Lymphoblastic Leukemia.


Eligibility criteria: Inclusion Criteria:

* Pathologically documented chronic myelogenous leukemia in blast crisis, myelodysplasia, acute myelogenous leukemia, or acute lymphocytic leukemia.
* Life expectancy of 12 weeks or greater.
* ECOG Performance Status less than or equal to 2.
* Meets protocol requirements for specified laboratory values.
* No manifestations of a malabsorption syndrome.

Exclusion Criteria:

* Patients who have received more than three chemotherapy regimens for more than three recurrences of the disease.
* Poor medical risks because of nonmalignant systemic disease as well as those with active uncontrolled conditions.
* Patients who have received investigational therapy of any type within 30 days prior to administration.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03162484: Physical Activity and Chronic Acquired Brain Injury
Official title: Effect of a Physical Activity Group Programme on the Health of People With Chronic Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Motor Activity
Quality of Life
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Most individuals who have survived an acquired brain injury (ABI) present consequences affecting the sensorimotor, cognitive, affective or behavioural components. The conditions can vary from mild to extreme. The consequences of an ABI may have a considerable impact on their functioning, and secondary conditions like depression or sedentary behaviours, so they suffer changes in their Health-Related Quality of Life (HRQoL).

The purpose of this project is to determine the effect of a physical activity group program on HRQoL. As well as to identify factors that facilitate or act as a barrier to practice physical activity.

Detailed description: This study is a quasi experimental pre-post test with nonequivalent group design. There were two groups: 30 subjects with chronic ABI took part in a physical activity group program designed by a Sport Club in Madrid, Spain; and 30 subjects with chronic ABI which did not practice physical activity.

Eligibility criteria: Inclusion Criteria:

* Individuals with mild to moderate chronic acquired brain injury from any cause.
* Being over 18 years of age.
* Being practice two or more sessions per week.
* Ability to understand and complete questionnaires in Spanish.
* Voluntary participation in the study.
* Signed informed consent by the patient and/or their primary caregiver.

Exclusion Criteria:

* Return to work
* Aphasia

Primary outcomes:
measure: Mood change measurement
timeFrame: Change from baseline mood at 18 weeks
measure: Quality of life change measurement
timeFrame: Change from baseline quality of life at 18 weeks
measure: Participation in Physical Activities change measurement
timeFrame: Change from baseline participation at 18 weeks
Secondary outcomes:
measure: Depression change measurement
timeFrame: Change from baseline depression at 18 weeks
measure: Months since injury
timeFrame: Baseline
measure: Amount of weekly physical activity
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Javier Pérez, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03776084: Compliance With Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Syndrome
Official title: Evaluation of Compliance With CPAP Therapy in Patients Diagnosed With Obstructive Sleep Apnea Syndrome at the Hospital de Sabadell
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea, Obstructive
Keywords: treatment adherence and compliance
attitudes
Continuous Positive Airway Pressure
cross-cultural validation
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2018-12-14
Enrollment: 405
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 diagnosed with OSAS and who underwent treatment with Continuous Positive Airway Pressure at the Hospital de Sabadell.

Brief summary: The aim of the study is to know the adherence to treatment and compliance of patients diagnosed with SAHS and with indication of CPAP from the sleep unit of the Hospital de Sabadell.

Detailed description: The investigatror's objective will be to know the adherence to treatment and compliance of patients diagnosed with SAHS and with indication of CPAP of the sleep unit of the Hospital de Sabadell. Is a cohort study. The dependent variables are adherence to treatment (% patients who continue using CPAP one year after initiation of treatment) and objective compliance with treatment (defined as use of ≥4h / night). For a confidence level of 95%, a sample of 405 patients was recruited, recruited consecutively at a rate of 33 patients per month among those diagnosed with SAHS and those indicated with CPAP treatment. This number foresees a possible abandonment rate of 5%. For the statistical analysis of the data related to compliance with the therapy and compliance with the follow-up process, descriptive analysis of the data with means, median and 95% CI, or percentages with 95% CI. For the statistical analysis of the factors influencing compliance: multivariate logistic regression.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age treated with CPAP based on the diagnosis of OSAS (clinical picture and AHI\> 10).

Exclusion Criteria:

* Diagnosis of a psychiatric illness or dementia.
* Communication problems or inability to read and speak Spanish.

Primary outcomes:
measure: Adherence rate to CPAP treatment
timeFrame: 1 year after starting treatment
measure: Ratio of patients with compliance with the treatment
timeFrame: 1 year after starting treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: CorporacionPT
state: Barcelona
Study officials:
affiliation: Corporacion Parc Tauli
name: Montserrat Montaña, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04826484: Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel
Official title: A Randomized Trial Evaluating Use of Long-Acting Liposomal Bupivacaine (Exparel®) in Reducing Narcotic Pain Requirements in Pediatric Patients Undergoing Minor Urologic Procedures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Urologic Diseases
Hypospadias
Undescended Testes
Chordee
Hydrocele
Orchiectomy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 104
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the utility of long-acting liposomal bupivacaine (Exparel®) in improving pain scores and reducing narcotic pain requirements in pediatric patients following minor urologic procedures.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients 6 years and older undergoing minor pediatric urologic surgery
* Patients who are otherwise eligible to receive routine care following minor urologic surgery

Exclusion Criteria:

* Contraindication to receiving local anesthetics (i.e. pre-existing cardiac, renal, hepatic dysfunction)
* Pediatric patients younger than 6 years of age
* Pediatric patients with a history of pain syndromes or are unable to tolerate opiate medication
* Unwilling to participate in 48 hours and 10-14 day follow-up phone calls

Primary outcomes:
measure: Percentage of Patients Who Are Opiate-free
timeFrame: 48 hours postoperatively
measure: Percentage of Patients Who Are Opiate-free at 10-14 Days Postoperatively
timeFrame: 10-14 days postoperatively
measure: Parents' Postoperative Pain Measure (PPPM) Scores
timeFrame: 48 hours postoperatively
measure: Parents' Postoperative Pain Measure (PPPM) Scores
timeFrame: 10-14 days postoperatively
Secondary outcomes:
measure: Amount of Opioid Medication Used Post-discharge
timeFrame: 10-14 days postoperatively
measure: Percentage of Patients With Leftover Opioid Medication
timeFrame: 10-14 days postoperatively
measure: Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity
timeFrame: 10-14 days postoperatively
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Heather N DiCarlo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02139384: Clinical Pediatric Pneumonia Score in Critically Ill Children
Official title: Development of a Clinical Pediatric Pneumonia Score in Critically Ill Children Admitted With Acute Respiratory Failure
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Community Acquired Pneumonia
Keywords: procalcitonin
community acquired pneumonia
pneumonia score
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Study population: critically ill children admitted the the LLU PICU with acute respiratory failure with suspected community-acquired pneumonia

Brief summary: The purpose of the study is to create a clinical pneumonia tool that can be used to predict the cause of community-acquired pneumonia, which is a lung infection that began outside of the hospital in critically ill children therefore limiting unnecessary antibiotic use. The investigators will enroll critically ill children admitted with acute respiratory failure and suspected pneumonia. Each patient will receive a clinical pneumonia score blinded from culture and respiratory viral panel results. All care after samples obtained will be at the discretion of the PICU team. The investigators believe that our clinical pneumonia scale with procalcitonin will accurately designate viral from bacterial etiologies.


Eligibility criteria: Inclusion Criteria:

* All intubated pediatric patients
* Age 1 day to 21 years
* Admitted to the LLUCH PICU with suspected pneumonia for the next 6 months
* Have received antibiotics for less than 12 hours
* Have been intubated for less than 24 hours
* Patients must be English or Spanish speaking for consent purposes.

Exclusion Criteria:

* Patients who have received antibiotics for greater than 12 hours
* Patients who have been intubated for greater than 24 hours
* Patients who are unable to tolerate non-bronchoscopic bronchoalveolar lavage

Primary outcomes:
measure: Can our proposed pneumonia score distinguish community acquired bacterial pneumonia from community acquired viral pneumonia
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Children's Hospital
state: California
Study officials:
affiliation: Loma Linda University
name: Cynthia Tinsley, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01475084: Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study
Official title: Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pleural Effusion
Pleural Diseases
Keywords: Flex-rigid pleuroscopy
cryobiopsy
pleural biopsy
pleural effusion
safety
thoracoscopy
Lead sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik
Sponsor class: OTHER
First posted: 2011-11-21
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: DIAGNOSTIC

Brief summary: The purpose of this study is to compare cryobiopsies with forceps biopsies during semirigid thoracoscopy.

Detailed description: The investigators are going to compare diagnostic yield and size, morphological features, immunohistochemistry as measures of the quality of the samples. The secondary aim is to evaluate safety with focus on bleeding intensity.

Eligibility criteria: Inclusion Criteria:

* 18 or more years old
* unilateral pleural effusion of unknown origin
* pleural irregularities suspicious for pleural malignancy
* referral for thoracoscopy after less invasive means of diagnosis had failed

Exclusion Criteria:

* uncontrolled bleeding tendency
* unstable cardiovascular status
* severe heart failure
* ECOG performance status 4
* persistent hypoxemia after evacuation of pleural fluid
* pleural symphisis, fibrothorax

Primary outcomes:
measure: Comparison of forceps biopsy and cryobiopsy samples
timeFrame: 12 month
Secondary outcomes:
measure: Safety
timeFrame: 1 month
Other outcomes:
Locations:
city: Golnik 36
country: Slovenia
facility: University Clinic Golnik
state: Golnik
Study officials:
affiliation: University Clinic Golnik
name: Ales Rozman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01814384: Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®.
Official title: Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About Medical Device.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Keywords: Ancillary tailored
medico-economic study,
total knee replacement
primary or secondary osteoarthritis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Total knee arthroplasty represents over 70 000 surgical procedures per year in France, increasing about 10% each year since the early 1990s. Clinical experience shows a strong rate of success on pain relieve and improvement of knee articular function for these patients.

Longevity of the implants had been proved to depend on the biomechanical design and implantation techniques, particularly the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta company allows to adapt bone cuts to the patient anatomy improving the reliability of these procedure. A reduction of surgical time and bleeding would be another benefit expected with this type of ancillary. The objective of this study is to demonstrate the advantage of patient matched cutting blocks for total knee arthroplasty on realiability for both clinical and radiological criteria, morbidity reduction during and after the procedure and also a benefit on an economic point of view.


Eligibility criteria: Inclusion Criteria:

all patients requiring a total knee arthroplasty line: primary or secondary osteoarthritis advanced beyond medical treatment.

Exclusion Criteria:

distorded axes or laxity requiring the establishment of constrained prosthesis

Primary outcomes:
measure: compare the functionality of the knee after installation of a total knee replacement between the 2 groups
timeFrame: 2 years after
Secondary outcomes:
measure: to assess knee function by autoquestionnaire KOOS, the KSS knee score, operative time, procedure bleeding, reliability of the ancillary
timeFrame: 2 years after
measure: medico-economic evaluation type "Cost minimization"
timeFrame: 2 years after
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital of Nantes
Study officials:
References:
Clinical trial NCT00318084: PPI Test in GP Patients
Official title: The Proton Pump Inhibitor Test in Reflux Disease: a Study Using Nexium in General Practice Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: GERD
Keywords: Gastroesophageal reflux disease
Heartburn
Acid-related diseases
Acid reflux disease
Nexium
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: UMC Utrecht
First posted: 2006-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the diagnostic value of two week treatment with Nexium as a confirmatory test for patients with suspected reflux disease.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Symptoms suggestive for gastric acid reflux disease during 2 or more days per week

Exclusion Criteria:

* Treatment with prokinetic or acid secretion inhibitors within 4 weeks prior to inclusion
* Treatment with a PPI for more than 30 days within the last 3 months prior to inclusion
* History of proven peptic ulcer disease, unless successfully treated with Helicobacter pylori eradication longer than 1 month before inclusion

Primary outcomes:
measure: Diagnostic test characteristics and the positive and negative predictive value of a 2-week Nexium-based PPI test using symptom analysis of 24-hour esophageal pH monitoring as gold standard.
Secondary outcomes:
measure: To assess the optimal duration of a Nexium-based PPI test, and the predictive value of different symptoms for presence of reflux-related symptoms.
measure: Obtain information on patient satisfaction, the course of reflux symptoms, the consumption of acid suppressing drugs, the disease-related quality of life at a follow up periods of 3 months in patients with a positive and negative PPI test.
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Netherlands Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04517084: Pre-surgical Motivation for Bariatric Surgery
Official title: A Retroactive Study on the Motivations of Patients Undergoing Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Undergone bariatric surgery within SGH LIFE Centre and completed the intake questionnaire.

Brief summary: A study investigating the motivations of patients who had undergone bariatric surgery using data collected from questionnaires given to patients prior to surgery.


Eligibility criteria: Inclusion Criteria:

* Undergone bariatric surgery at Singapore General Hospital and completed the life center questionnaire.

Exclusion Criteria:

-

Primary outcomes:
measure: Weight Loss
timeFrame: 5 years post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yale-NUS College
Study officials:
References: