louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02555605: Dexmedetomidine Sedation in Children With Respiratory Morbidities
Official title: Feasibility of Dexmedetomidine in Children With Respiratory Morbidities Undergoing Deep Sedation for Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Morbidity
Keywords: children
dexmedetomidine
magnetic resonance imaging scans
deep sedation
adverse respiratory events
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2015-09-21
Enrollment: 19
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children up to the age of 16 years with at least 3 characteristics of respiratory morbidities were identified as having increased risk for adverse respiratory events and they were eligible for participation in this evaluation.

Brief summary: This study aimed to determine the feasibility of dexmedetomidine in children with respiratory morbidities who required deep sedation for magnetic resonance imaging (MRI) scans.

Detailed description: Electronic medical records of children with at least 3 characteristics of respiratory morbidities were retrospectively reviewed. All study patients received dexmedetomidine bolus over 10 min followed by a continuous infusion to achieve a minimum Ramsay Sedation Score of 5. Patients were monitored for hemodynamics, total dose of dexmedetomidine received, adverse events experienced and sedation characteristics.

Eligibility criteria: Inclusion Criteria:

* Children up to the age of 16 years with at least 3 characteristics of respiratory morbidities

Exclusion Criteria:

* Children who had an American Society of Anaesthesiologists (ASA) physical status classification IV
* Documented pre-existing cardiac conduction abnormalities
* Renal impairment

Primary outcomes:
measure: the occurrence of successful sedation
timeFrame: 1 hour
Secondary outcomes:
measure: the presence of bradycardia
timeFrame: 4 hours
measure: the presence of hypertension
timeFrame: 4 hours
measure: the presence of nausea and vomiting.
timeFrame: 4 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Vlaams Brabant
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Nadia Najafi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Jan Poelaert, PhD MD
role: STUDY_CHAIR
References:
citation: Najafi N, Veyckemans F, Van de Velde A, Poelaert J. Usability of dexmedetomidine for deep sedation in infants and small children with respiratory morbidities. Acta Anaesthesiol Scand. 2016 Aug;60(7):865-73. doi: 10.1111/aas.12715. Epub 2016 Mar 4.
Clinical trial NCT05189405: 3 Year Retrospective Analysis of IVF in Comparison With INVOcell
Official title: A 3 Year Retrospective Analysis of Fertility Clinic's of In Vitro Fertilization (IVF) in Comparison With INVOcell Intravaginal Culture (INVOcell IVC) Device
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Lead sponsor: INVO Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-12
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects that have received infertility treatment with either INVOcell IVC or standard IVF during the same timeframe. All subjects treated with the standard of care IVF method during the same timeframe that the center used INVOcell IVC were included in the retrospective data collection.

Brief summary: Retrospective chart review of data on the use of traditional IVF and INVOcell IVC collected from clinics using both technologies. The retrospective data will be utilized for a comparison of the two methods.

Detailed description: The following aspects of data will be collected to support the analysis of the two methods

* Procedure details for including oil overlay and incubation time frame
* Characteristics of embryo quality and phase of development and transfer rates
* Clinical pregnancy rate
* Live birth rate Secondary: Data regarding safety
* Adverse events noted by the women that received IVF and INVOcell IVC
* Adverse events noted for the offspring

Eligibility criteria: Inclusion Criteria:

* Subjects that have received infertility treatment with either INVOcell IVC or standard IVF during the same timeframe. All subjects treated with the standard of care IVF method during the same timeframe that the center used INVOcell IVC were included in the retrospective data collection.

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Embryo development
timeFrame: 5 days
measure: Clinical pregnancy rate
timeFrame: 5 days
measure: Live birth rate
timeFrame: 5 days
Secondary outcomes:
measure: Maternal Adverse Events
timeFrame: 5 days
measure: Offspring adverse events
timeFrame: 5 days
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Carolina Conceptions
state: North Carolina
city: Greenville
country: United States
facility: Piedmont Reproductive Endocrinology Group
state: South Carolina
city: Bedford
country: United States
facility: CARE Fertility
state: Texas
city: Virginia Beach
country: United States
facility: THE NEW HOPE CENTER for Reproductive Medicine
state: Virginia
Study officials:
References:
Clinical trial NCT00348205: A Study to Evaluate the Safety and Effectiveness of the Technols 217z Zyoptix System for Hyperopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperopia
Astigmatism
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 80
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: A study to demonstrate the safety and effectiveness of wavefront laser refractive surgery treatments for hyperopia and astigmatism.


Eligibility criteria: Inclusion Criteria:

* Hyperopia with or without astigmatism.

Exclusion Criteria:

* Contraindications to LASIK.

Primary outcomes:
measure: Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better at 12 Months and 24 Months
timeFrame: 24 months
measure: Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia.
timeFrame: 12 months
measure: The Percentage of Eyes With a Postoperative Subjective Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.00 Diopter (D) and ± 0.50 D of Emmetropia
timeFrame: 24 months
measure: Refractive Stability - Categorical Change Between Month 1 and Month 3
timeFrame: Month 1, Month 3
measure: Refractive Stability - Mean Change Between Month 1 and Month 3
timeFrame: 1 month, 3 months
measure: Induced Astigmatism
timeFrame: 24 months
Secondary outcomes:
measure: Loss of Best Spectacle-corrected Visual Acuity (BSCVA)
timeFrame: 24 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb
state: New York
Study officials:
References:
Clinical trial NCT04581005: Prehabilitation in Esophageal Cancer Care
Official title: Prehabilitation to Enhance Functional Capacity in Esophageal Cancer Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prehabilitation utilizes the preoperative period to prevent or attenuate the treatment-related functional decline and its consequences. This project aims at testing feasibility and effectiveness of multimodal prehabilitation in esophageal cancer care.

Detailed description: While evidence on prehabilitation is mounting, upper gastrointestinal surgery still remains under-investigated. This trial aims to explore the effect of prehabilitation over the whole perioperative trajectory, including neo-adjuvant treatment (NAT).

Multimodal prehabilitation includes exercise, nutrition therapy, and mental distress coping strategies. In the context of a multimodal approach, the two groups follow different exercise prescriptions: high-intensity interval supervised training prescribed accordingly cardiopulmonary exercise testing (CPET)-derived variables, versus a home-based program. For both groups, multimodal prehabilitation is prescribed over the whole preoperative period, including during NAT.

Eligibility criteria: Inclusion Criteria:

* Patients with non-metastatic esophageal cancer undergoing neo-adjuvant chemotherapy and surgery.

Exclusion Criteria:

* co-morbid medical, physical and mental conditions that contraindicate exercise or oral nutrition

Primary outcomes:
measure: Oxygen consumption (VO2)
timeFrame: Change from baseline to 2 months after surgery
measure: Oxygen consumption (VO2)
timeFrame: Change from baseline to post neo-adjuvant therapy (average duration 6-8 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University
name: Enrico M Minnella, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02662205: Group Yoga Therapy at a College Counseling Center
Official title: A Controlled Trial of Group Yoga Therapy at a College Counseling Center
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Psychological Distress
Mindfulness
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clients of the student counseling center at Oklahoma State University who are interested in participating in the study will be randomly assigned to a traditional process group, a yoga class, and a yoga therapy group. Outcome of the three conditions will be compared.

Detailed description: Clients will be screened for appropriateness for group treatment and yoga. They will be randomly assigned to a traditional process group, a yoga class, and a yoga therapy group. Each condition will run concurrently for 8 weeks. Outcome measures will be administered before trial commencement and after the trial ends.

Eligibility criteria: Inclusion Criteria:

* Students at Oklahoma State University
* Appropriate for group therapy
* Physically capable of doing yoga

Exclusion Criteria:

* non-students
* inappropriate for group therapy treatment
* physical injuries not appropriate for yoga participation

Primary outcomes:
measure: Counseling Center Assessment of Psychological Symptoms-62
timeFrame: change from baseline at 8 weeks
measure: Outcome Questionnaire- 45.2
timeFrame: change from baseline at 8 weeks
measure: Mindful Attention and Awareness Scale
timeFrame: change from baseline at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05328505: Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer
Official title: Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
adenocarcinoma
PSMA PET
radical prostatectomy
recurrence
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II prospective sing-arm trial that is recruiting 60 participants from patients that have biochemical failure after radical prostatectomy with local or regional recurrence proven by PSMA PET. Participants of this study will receive molecular imaging informed radiation dose escalation to site of recurrent disease and de-escalation to uninvolved areas. Participants will be follow-up as per standard of care up to 5 years post-treatment.


Eligibility criteria: Inclusion Criteria:

* Men older than 18 years old.
* Histologically proven initial diagnosis of adenocarcinoma prostate cancer.
* Previous radical prostatectomy.
* Biochemical relapse with local or regional recurrence proven on PSMA PET.
* Five or less positive nodes on the PSMA PET.
* ECOG 0-1

Exclusion Criteria:

* Presence of para-aortic lymph nodes or distant metastasis.
* Chronic pelvic inflammatory disease.
* Contraindication for radiation treatment.
* Previous radiation treatment within the pelvis

Primary outcomes:
measure: Grade ≥2 Toxicity for GU
timeFrame: Baseline to 5-year follow-up
Secondary outcomes:
measure: Biochemical Failure Free Survival
timeFrame: Baseline to 5-year follow-up
measure: Patient-reported quality-of-life assessed by EPIC-26
timeFrame: Baseline to 5-year follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
Study officials:
References:
Clinical trial NCT02909205: a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised
Official title: Development and Evaluation of a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrostomy
Keywords: child
gastrostomy
supportive care
educational program
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 40
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to improve care practice related to gastrostomy management. This a before-after study, aimed at evaluating knowledge of care givers, families and patients about gastrostomy management. The intervention includes 1) A training in a care protocol for hospital care givers, and 2) A booklet for patients, families, and outpatient care givers. The evaluation criterion is a questionnaire to assess knowledge of hospital care givers, patients, families, and outpatient care givers.


Eligibility criteria: Inclusion Criteria:

* parents and hospital care givers of children undergoing gastrostomy who accept to participate.

Exclusion Criteria:

* family unable to understand French language, caregiver who has previously answered to the study questionnaire

Primary outcomes:
measure: Change from knowledge score
timeFrame: Between day 0 and day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
affiliation: Hospices Civils de Lyon
name: Frédéric VALLA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05897697: Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
Official title: Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Pregnancy Related
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women in a current pregnancy or within 7 days of delivery.

Brief summary: The preferences of pregnant women for postpartum thromboprophylaxis are largely unknown. The aims of this transversal study are to elicit the preferences of pregnant/postpartum women about postpartum thromboprophylaxis in semi-structured interviews, and to estimate the utility of the relevant health states (pulmonary embolism, deep vein thrombosis, postpartum hemorrhage, subcutaneous injections). In this second aim, the investigators will also compare the effect of 2 different techniques to estimate utilities (standard gamble vs. time trade-off), using a randomization of these techniques.


Eligibility criteria: Inclusion Criteria:

* women
* ongoing pregnancy or within 7 days of delivery
* fluency in French or English

Exclusion Criteria:

* fetal or neonatal death

Primary outcomes:
measure: Preference for postpartum thromboprophylaxis
timeFrame: 90 days of delivery
measure: Quality-of-life of pulmonary embolism, deep vein thrombosis, postpartum hemorrhage and subcutaneous injections
timeFrame: 90 days of delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Justine Hugon-Rodin
city: Geneve
country: Switzerland
facility: Marc Blondon
Study officials:
References:
Clinical trial NCT04181697: HemFitBit, an Observational Study of Physical Activity in People With Moderate and Severe Haemophilia A
Official title: The HemFitBit-study: Defining Normal Physical Activity in Haemophilia A
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A Without Inhibitor
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
First posted: 2019-11-29
Enrollment: 40
Sex: MALE
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young people with moderate and severe haemophilia A, without inhibitors and on continuous prophylaxis will be identified from the national registry of PwH.

Brief summary: The study aims to describe physical activity (PA) levels in young people with haemophilia A in Norway compared with non-haemophilia controls, and to identify factors influencing PA. This will be conducted through an observational study measuring PA over 12 weeks. Forty young people with moderate and severe haemophilia A will be enrolled. PA data will be compared to demographically and seasonally matched non-haemophilia controls. PA will be measured using the activity tracker Fitbit Charge 3. A subgroup of participants will also wear the hip-worn accelerometer ActiGraph GTX+BT for seven consecutive days in order to validate the two devices against each other.


Eligibility criteria: Inclusion Criteria:

* moderate or severe haemophilia A
* no inhibitor
* on continuous prophylaxis

Exclusion Criteria:

* current inhibitor

Primary outcomes:
measure: Physical Activity (PA) volume
timeFrame: 9 months
measure: Fulfilment of PA recommendations
timeFrame: 9 months
measure: Trend in PA over time
timeFrame: 9 months
measure: Physical activity types
timeFrame: 9 months
Secondary outcomes:
measure: Impact of haemophilia on daily life
timeFrame: 9 months
measure: Health Related Quality of Life
timeFrame: 9 months
measure: Joint score
timeFrame: 9 months
measure: Ultrasound joint score
timeFrame: 9 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
Clinical trial NCT05544097: Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis
Official title: Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bowel Sounds
Spectral Analysis
Necrotizing Enterocolitis
Preterm Babies
Keywords: bowel sounds
spectral analysis
Necrotizing Enterocolitis
preterm babies
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 50
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The recording or bowels is easy and cheap. The investigators wonder if these sounds are modified in babies with high risk of necrotizing enterocolitis. In this study, the investigators suggest to record and do a spectral analysis of 30 seconds of bowel sounds in preterm babies of less than 32WA before and after enteral nutrition, every day until the end of hospitalization. A spectral analysis will be made for each record to determine frequencies of the signal. The investigators will try to determine physiological frequencies and look for modifications in pathological situations.


Eligibility criteria: Inclusion Criteria:

* preterm babies of less than 32WA

Exclusion Criteria:

* preterm babies of more than 32WA,
* digestive congenital malformation

Primary outcomes:
measure: variation of spectral analysis of bowel sounds (frequency in Hz) before and after enteral nutrition
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References: