louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05499273: Pediatric Neck Rescue Access Comparison
Official title: Pediatric Neck Rescue: Randomized Comparison of Two Emergency Approaches to the Trachea in an Advanced Simulated Rabbit Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheostomy Complication
Anesthesia
Keywords: pediatric airway
tracheotomy
eFONA
CICO
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Gaslini Children's Hospital
First posted: 2022-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Two recent studies explored the emergency tracheotomy technique and the scalpel-bougie-tracheostomy technique as a neck rescue access for newborns and infants on a rabbit cadaver. Both studies lacked a key feature of real surgical access - bleeding during a true emergency. The study's objective was to comparatively assess the two techniques in a simulated environment with simulated bleeding and decreasing vital signs from the monitor like in real emergencies.

Detailed description: With ethical committee's approval the investigarors recruited for this cross-over trial pediatric anesthesiologists and intensivists. Emergency tracheotomy consists of four steps: vertical skin incision, strap muscles separation (2 Backhaus clamps), anterior luxation of the trachea with a 3rd clamp, and vertical puncture with tip-scissors of no more than 2 tracheal rings to insert the tube. The scalpel-bougie-tracheostomy involves separation of neck tissues to expose the trachea and tracheal incision both with a scalpel to insert the bougie to facilitate tracheal intubation. Participants were randomized to start either with emergency tracheotomy or scalpel-bougie-tracheostomy. They watched an instructional video and had four practicing attempts, followed by a fifth attempt which was assessed. Afterward, they crossed over to the other technique.

Eligibility criteria: Inclusion Criteria:

* board certified pediatric anesthesiologists or pediatric intensive care doctor
* informed consent signed

Exclusion Criteria:

* none

Primary outcomes:
measure: Performance Time
timeFrame: 2 min
Secondary outcomes:
measure: rate of cricoid injuries
timeFrame: 2 min
measure: Succes rate
timeFrame: 2 min
measure: rate of thyroid injuries
timeFrame: 2 min
measure: number of tracheal ring damaged
timeFrame: 2 min
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: University of Bern
name: Thomas Riva, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01917773: Effect of Octreotide on the Colonic Motility in Pediatric Patients
Official title: Effect of Octreotide on the Colonic Motility in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonic Motility Index
Constipation
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2013-08-07
Enrollment: 13
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The research study is designed to test how a medication called octreotide affects the motility (contraction or squeezing) of the colon (large intestine). Investigators are investigating whether octreotide can increase contraction and movement in the colon.

Detailed description: As mentioned above.

Eligibility criteria: Inclusion Criteria:

* Male or female and undergoing colonic manometry for a routinely accepted indication including: evaluation of chronic constipation, unexplained abdominal distension (Should have had previous diagnostic work up), recurrent fecal impaction, post Hirschsprung's disease repair, chronic intestinal pseudo-obstruction, or suspected colonic dysmotility of any other cause.
* Children aged 12 months or older who are undergoing colonic motility under the supervision of Dr. Joseph Croffie at Riley Hospital.
* In the investigator's judgment, parent(s)/guardian(s) is mentally competent to provide informed consent to participate in the study.

Exclusion Criteria:

* • Subjects with known or suspected allergy to octreotide.

  * Subjects with known prolonged corrected QT interval (QTc) Syndrome or highest risk QTc-Prolonging Agents (including mifepristone).
  * Subjects with known history of ventricular arrhythmia.
  * Subjects with history of any organ transplant who are taking cyclosporine at the time of the motility study.
  * Subjects with history of small bowel transplant.
  * Subjects less than 12 months old.
  * Subjects with severe renal impairment
  * Subjects with severe hepatic impairment
  * Subjects taking bromocriptine, insulin, oral hypoglycemic agents, beta blockers, calcium channel blockers, quinidine, terfenadine, pimozide, sildenafil, tadalafil, and any agents to control fluid and electrolyte imbalance

Primary outcomes:
measure: Compared Colonic Motility Index From Fasting to Post Octreotide Infusion
timeFrame: Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide.
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Motility Laboratory, Division of Pediatric Gastroenterology, Hepatology and Nutrition at the James Whitcomb Riley Hospital for Children,
state: Indiana
Study officials:
affiliation: Riley Hospital for Children
name: Joseph Croffie
role: STUDY_DIRECTOR
References:
Clinical trial NCT06090773: Characteristics of Renal Blood Flow in AKI Patients in ICU and Its Clinical Significance
Official title: Characteristics of Renal Blood Flow in AKI Patients With Sepsis and Its Clinical Significance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Renal Artery Blood Flow
Renal Venous Return
Renal Microcirculation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Age between 18-85 years old; Control group: patients with non-acute kidney injury after ICU general surgery; Observation group: patients who met the diagnostic criteria of AKI: Scr elevation ≥26.5 umol/L within 48h; Scr elevation exceeding 1.5 times and more than the basal value within 7d; and decrease in urine output (\<0.5 ml/kg/h) with a duration of 6h or more.

Brief summary: To study the changes in the renal artery and renal vein with renal cortical and medullary microcirculatory blood flow in patients with sepsis; to study the relationship between renal arteriolar and renal vein with renal cortical and medullary microcirculatory blood flow and renal function; and to find the value of ultrasonographic assessment of renal blood flow indices for evaluating prognosis in patients with sepsis.


Eligibility criteria: Inclusion Criteria:

* Age between 18-85 years old; Control group: patients with non-acute kidney injury after ICU general surgery; Observation group: patients who met the diagnostic criteria of AKI: Scr elevation ≥26.5 umol/L within 48h; Scr elevation exceeding 1.5 times and more than the basal value within 7d; and decrease in urine output (\<0.5 ml/kg/h) with a duration of 6h or more.

Exclusion Criteria:

* Those who did not meet the inclusion criteria or refused to be enrolled; patients with underlying end-stage renal disease or requiring long-term dialysis; renal transplant patients; patients with other underlying systemic diseases causing renal dysfunction (SCr \> 88.4 umol/L); those who were unable to obtain a clear renal ultrasound view; those with suspected contrast allergy; those with pulmonary arterial systolic blood pressure ≥ 90 mm Hg; and those who were pregnant or breastfeeding women.

Primary outcomes:
measure: 30-day major renal adverse events
timeFrame: 30-day
measure: Renal artery blood flow
timeFrame: Day 1,Day 3,Day 5, Day 7
measure: Renal venous return
timeFrame: Day 1,Day 3,Day 5, Day 7
measure: renal microcirculation
timeFrame: Day 1,Day 3,Day 5, Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Rongping Chen
state: Beijing
Study officials:
References:
Clinical trial NCT03627273: 6MWT With and Without Walker
Official title: Comparison of 6 Minute Walk Test With and Without Walker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Elderly
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 86
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Elderly subjects repeated 6MWT with or without walker


Eligibility criteria: Inclusion Criteria:

* clinically stable
* aged over 65 years
* could walk
* did not use walker frames in routine

Exclusion Criteria:

* criteria outlined in the European respiratory society/American thoracic society technical standard related to 6MWT
* impaired cognitive function

Primary outcomes:
measure: six minutes walking test
timeFrame: six minutes
Secondary outcomes:
measure: Modified Borg scale
timeFrame: six minutes
measure: heart rate
timeFrame: six minutes
measure: pulsed oxygen saturation
timeFrame: six minutes
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT06331273: Impact of "No-touch" Technique on the Outcome of Liver Transplantation for Hepatocellular Carcinoma
Official title: Impact of "No-touch" Technique on the Outcome of Liver Transplantation for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Transplantation
No-touch Technique
Hepatocellular Carcinoma
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Shulan (Hangzhou) Hospital
First posted: 2024-03-26
Enrollment: 800
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: HCC patients who undergoing deceased donor liver transplantation for the first time.

Brief summary: The "no-touch" technique has been one of the most important principles of oncological surgery and aimed to prevent seeding and tumor cell dissemination. Previous studies in hepatectomy have shown that no-touch technique surgery can reduce HCC recurrence and improve the survival of patients. However, there is no consensus on whether the no-touch technique in LT for HCC improves the outcomes. This study aims to prospectively include liver transplant patients from multiple transplant centers, collecting their pre-transplant clinical information, post-transplant pathological records and exploring and clarify the correlation between "no-touch" technique and the prognosis of LT patients.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of HCC based on CT or MRI imaging or needle biopsy confirming a histologic diagnosis of HCC.
2. Patients undergoing deceased donor liver transplantation for the first time.

Exclusion Criteria:

(1) patients who received split LT or simultaneous transplantation, (2) patients who received re-transplantation, (3) patients with macroscopic portal vein tumor thrombosis or other macrovascular invasion, (4) patients with incomplete follow-up or incomplete important parameters records.

Primary outcomes:
measure: Recurrence free surviavl rate
timeFrame: 2024.4.1-2028.4.1
measure: Overall survival rate
timeFrame: 2024.4.1-2028.4.1
measure: Tumor recurrence rate
timeFrame: 2024.4.1-2028.4.1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05959473: EGFR_IUO 3.20 Clinical Study Protocol
Official title: Idylla™ EGFR_IUO/3.20 Mutation Test a Clinical Trial Assay in the AstraZeneca Phase III NeoADAURA Clinical Trial (D516AC00001) Clinical Study Protocol
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: NSCLC
Lead sponsor: Biocartis NV
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2023-07-25
Enrollment: 0
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: An interventional, prospective clinical performance study protocol, for the testing of DNA extracted from FFPE Fine needle aspirate samples, using the Idylla EGFR_IUO/3.20, from patients with Non-Small Cell Lung Cancer screened in AstraZeneca's NeoADAURA clinical trial (Protocol No. D516AC00001)

Detailed description: This is a prospective, interventional diagnostic study using the For Investigational Use Only EGFR_IUO/3.20 for FFPE FNA sections. Screened patients with available FNA specimens, collected per SoC, who are found to have exon 19 deletions or L858R mutations in the EGFR gene based on the results of EGFR_IUO/3.20 and who meet all other study eligibility criteria will be randomized into one of three arms of the NeoADAURA study: neoadjuvant osimertinib as monotherapy or in combination with pemetrexed/platinum chemotherapy, versus pemetrexed/platinum chemotherapy plus placebo.

The use of the investigational IVD does not require invasive sampling that is not part of standard of care (SoC). Investigational testing for patient selection will be performed on FFPE FNA specimens, obtained as SoC for diagnosis and/or pathologic staging prior to definitive surgery. By using available specimens obtained as SoC, there is no risk to patients as a result of invasive sampling for EGFR testing.

Eligibility criteria: Inclusion Criteria:

• All patients who provided consent (by signing and dating the Consent Form for AstraZeneca NeoADAURA Protocol No. D516AC00001), may be included in the device study.

Exclusion Criteria:

* Patients whose FFPE FNA samples are not Clinical Trial Assay evaluable will be excluded from the study.
* Patients with samples identified for the study which have insufficient testing material will also be excluded.

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: 7 business days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02805673: Osteopathic Support Evaluation of Fibromyalgia Patients
Official title: Osteopathic Support Evaluation of Fibromyalgia Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: Osteopathy
Support
Treatment
Pain
Quality of Life
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 32
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: At present, the literature does not account for much of scientific data on the assessment of osteopathic intervention for patients with (Fibromyalgia) FM. The investigators propose a pilot study evaluating the efficacy of osteopathic care, consists of several osteopathic interventions in the treatment of FM, in order to improve the painful experiences of FM patients. This study must include 44 patients with FM according to (American College of Rheumatology) ACR criteria and followed the University Hospital of Caen.

The osteopathic care will last eight months and will be followed by a report three months after the end of osteopathic interventions. This in order to evaluate the effect in the short term and long term, of osteopathic care in patients with FM.


Eligibility criteria: Inclusion Criteria:

* FM patient diagnosed according to the ACR criteria.
* Patient Having realized biological balances excluding any underlying pathology that may be causing the pain.
* Patient Over 18 years followed at Caen University Hospital.
* Patient Treated with drugs to its FM.
* Patient Being informed and having signed his consent.
* Patient Affiliated to the social security system.
* French-Patient.

Exclusion Criteria:

* FM undiagnosed according to the ACR criteria.
* Patient Showing against -indications to the osteopathic surgery.
* Patient Treated by manual therapy ( physiotherapy, osteopathy, acupuncture... ) during the trial and during the three months preceding the study.
* Concomitant Maladie (type cancers, cardiovascular diseases, rheumatic diseases ) or all diseases causing bone pain and myalgia.
* Important Surgery of less than 3 months.
* Inability to submit to medical monitoring study for geographical or social reasons.
* Inclusion The subject in another biomedical research protocol for this study.
* Women Pregnant or nursing.

Primary outcomes:
measure: Visual Analogue Scale for pain
timeFrame: chenge between Day 232 - Day 0
Secondary outcomes:
measure: Visual Analogue Scale for pain
timeFrame: change after Week 6, Week 12, Week 18, Week 24, Week 32, Week 38 and day 301, compared to day 0
measure: QDSA score
timeFrame: at day 232 until day 301 and compared to day 0
measure: SF-36 score
timeFrame: at day 232 until day 301 and compared to day 0
measure: number of tender points
timeFrame: at day 232 to day 301 and compared to day 0
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen
Study officials:
affiliation: CHU CAEN
name: Françoise CF COURTHEOUX, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02016573: Renal Denervation for Uncontrolled Hypertension
Official title: Renal Denervation for Uncontrolled Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertension
Keywords: renal denervation
blood pressure
cardiovascular risk
target organ damage
sympathetic activity
Lead sponsor: Baker Heart and Diabetes Institute
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study investigating the safety and usefulness of the Renal Denervation Procedure in reducing high blood pressure in people whose blood pressure is not adequately controlled despite already being treated with 2 blood pressure lowering drugs. This study is designed to compare the effects renal denervation to a usual care group.

Detailed description: This is a phase 4 randomised control trial of renal denervation for the treatment of uncontrolled hypertension.

Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure.

A total of 100 participants with uncontrolled blood pressure, treated with two blood pressure lowering medications will be recruited into the study. Patients will be assigned to one of two groups. Participants in Group 1 will be assigned to undergo the renal denervation procedure. Participants in group 2 will undergo usual care, receiving additional antihypertensive medication in an attempt to reach blood pressure targets.

The duration of this study is 36 months.

Eligibility criteria: Inclusion Criteria:

* BP ≥140/90 mmHg (or ≥130/80 mmHg for patients with diabetes)
* concurrent treatment with 2 anti-hypertensive drugs

Exclusion Criteria:

* renal artery anatomy ineligible for treatment
* eGFR \<15mL/min/1.73m2 (using MDRD formula)
* individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit
* female participants of child bearing potential must have negative pregnancy test prior to treatment

Primary outcomes:
measure: blood pressure control
timeFrame: 6 months post procedure
Secondary outcomes:
measure: number of drugs required to reach target blood pressure
timeFrame: baseline to 6 months
measure: time to achieve blood pressure target
timeFrame: baseline to 6 months
measure: change in sympathetic nerve activity
timeFrame: baseline to 6 months
measure: Change in left ventricular function
timeFrame: baseline to 6 months
measure: Change in Quality of Life
timeFrame: baseline to 6 months
measure: Change in Serum Biochemistry
timeFrame: baseline to 6 months
measure: Change in markers of arterial stiffness
timeFrame: baseline to 6 months
measure: Change in left ventricular structure
timeFrame: baseline to 6 months
measure: Change in Urine Biochemistry
timeFrame: baseline to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Baker IDI Heart & Diabetes Institute
name: Markus P Schlaich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06170073: Hong Kong Cohort of Abnormal Sleep in Ageing Population (HK-ASAP): Focusing on Brain Health and Sleep Quality
Official title: Hong Kong Cohort of Abnormal Sleep in Ageing Population (HK-ASAP): an Observational Study on Brain Health and Sleep Quality in Community-dwelling Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disturbance
Aging
Cognitive Decline
Brain Disease
Keywords: Ageing
Sleep disturbances
Cognition
Brain health
Longevity
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
First posted: 2023-12-14
Enrollment: 238
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy normal ageing adults and adults with sleep disturbances.

Brief summary: Poor sleep quality can significantly jeopardize the brain health, cognitive functions, daily activities, quality of life, and even be implicated as a key potential contributing factor in the development of accelerated cognitive decline and prodromal dementia. Consequently, research efforts to understand, and therefore potentially model, the effects of sleep quality on cognition and brain health are of great pragmatic values.

Detailed description: Objectives: This study aims to investigate the cognitive changes in older adults with sleep disturbances, examine the neuroimaging contributors to poor sleep quality and cognitive deficits.

Eligibility criteria: Inclusion Criteria:

* Chinese old adults are the ones who are over 60 years of chronological age.
* Sleep disturbance: individual's subjective sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI) with a total score \>5.

Exclusion Criteria:

* History of bipolar disorders or psychosis.
* History of major neurological deﬁcits, including stroke, transient ischemic attack or brain tumor.
* Unable to participant magnetic resonance imaging (MRI) scanning.

Primary outcomes:
measure: Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline
measure: Global cognition will be measured by the Montreal Cognitive Assessment Hong Kong version (HK MoCA)
timeFrame: Baseline
measure: Complex attention will be measured by the Attention Network Test (ANT)
timeFrame: Baseline
Secondary outcomes:
measure: Memory and learning will be measured by the Word list learning test (WLLT)
timeFrame: Baseline
measure: Executive functions will be measured by the category verbal fluency test (CVFT)
timeFrame: Baseline
measure: The levels of Aβ40 and Aβ42 will be measured by saliva analysis
timeFrame: Baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
state: Tai Po
Study officials:
affiliation: Chinese University of Hong Kong
name: Hanna LU, PhD
role: PRINCIPAL_INVESTIGATOR
References: