louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06054022: Usage of High Flow Nasal Cannula in Preventing Desaturations in Elderly Patients Going for Lower Limb Surgeries
Official title: Comparing Intraoperative High Flow Nasal Cannula Therapy and Convetional Oxygen Therapy in Preventing Perioperative Hypoxaemia In Elderly Patients Undergoing Orthopaedic Surgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia During Surgery
Atelectasis
Keywords: high flow nasal cannula
elderly
orthopaedic
hypoxaemia
regional anaesthesia
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To study the effect of high flow nasal cannula in comparisons with nasoprong used intraoperatively in patients oxygenation status

Detailed description: To observe the effect of high flow nasal cannula used intraoperatively compared to normal oxygen therapy (nasoprong) at a same fraction of inspired oxygen (FiO2) in elderly patients who are going for orthopaedic surgeries under central neuraxial block.

oxygenation will be access with intermittent blood gas. atelectasis will be access via chest x-ray , compared to a baseline chest x-ray, validated by a blinded radiologist

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) I, II or III patients.
2. Patients age 60 years and above
3. Patients scheduled for total knee replacement therapy and hip surgeries under central neuraxial block under the elective and emergency list.

Exclusion Criteria:

1. Patients with pre-operative spO2\<94%
2. Patients delirious or demented / unable to give consent.
3. Patients with pre-existing pneumonia (defined as the initiation of antibiotics for suspected infection with one or more of the following: new or changed sputum; new or changed lung opacities; fever; white blood cell count \>12 × 109 litre-1 )15
4. BMI ≥35

Primary outcomes:
measure: Incident of intraoperative desaturation
timeFrame: From induction time until end of surgery
measure: Patient comfort on high flow nasal cannula
timeFrame: At end of surgery till discharge to ward (recovery area)
measure: Atelactasis
timeFrame: From end of operation until 24 hours post surgery
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Time of hospital admission to time of discharge up to 30 days which ever come first
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Universiti Kebansaan Malaysia
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: National University of Malaysia
name: Syarifah noor nazihah binti sayed masri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04995822: Post Market Clinical Follow-up of EUROSTEM Femoral Stem
Official title: Post Market Clinical Follow-up of EUROSTEM Femoral Stem
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hip Osteoarthritis
Hip Arthropathy
Hip Arthritis
Hip Necrosis
Hip Fractures
Hip Dysplasia
Lead sponsor: EUROS
Sponsor class: INDUSTRY
First posted: 2021-08-09
Enrollment: 131
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: Patient who fulfill the criteria of eligilibilty according to the instructions for use of EUROSTEM

Brief summary: EUROSSTEM is intended for use in primary and revision total hip replacement surgery.

Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

As part of post market vigilance, EUROS will collect data on EUROSTEM performances and safety

Detailed description: Post market observational study. This study is multicenter, prospective, non comparative.

Eligibility criteria: Inclusion Criteria:

* Patient who received EUROSTEM
* Patient informed of its participation to the study
* Patient aged over 18 to date of surgery

Exclusion Criteria:

* Patient presenting a contraindication to EUROSTEM implantation.
* Patient who refused to participate to the study
* Vulnerable subjects

Primary outcomes:
measure: Safety of EUROSTEM Femoral Stem
timeFrame: 1 year
Secondary outcomes:
measure: Radiological performances of EUROSTEM Femoral Stem
timeFrame: 1 year
measure: Clinical performances of EUROSTEM Femoral Stem
timeFrame: 1 year
measure: Survival of EUROSTEM Femoral Stem
timeFrame: 10 year
Other outcomes:
Locations:
city: Puilboreau
country: France
facility: Clinique du Mail
state: La Rochelle
city: Agen
country: France
facility: Clinique Esquirol St Hilaire
city: Aix-en-Provence
country: France
facility: CH Aix en Provence
city: Arnas
country: France
facility: Polyclinique du Beaujolais
city: Avignon
country: France
facility: Clinique Montagard
city: Dijon
country: France
facility: Polyclinique du Parc Drevon
city: Grasse
country: France
facility: Clinique du Palais
city: Guilherand Granges
country: France
facility: Hôpital privé Drôme Ardèche - Clinique Pasteur
city: Saintes
country: France
facility: Clinique Richelieu
Study officials:
References:
Clinical trial NCT00218322: Effectiveness of ATMX in Treating Adolescents With ADHD and SUD
Official title: Atomoxetine in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorder (SUD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Disorder With Hyperactivity
Substance-Related Disorders
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-09-22
Enrollment: 108
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adolescents with attention deficit hyperactivity disorder (ADHD) often develop substance use disorders (SUD). The purpose of this study is to evaluate the effectiveness of atomoxetine in treating adolescents dually diagnosed with ADHD and SUD.

Detailed description: High rates of ADHD have been reported in adolescents with SUD. In addition, untreated ADHD is a risk factor for developing SUD. Atomoxetine is a norepinephrine reuptake inhibitor, and is currently used to treat adolescents with ADHD. The purpose of this trial is to evaluate the efficacy of atomoxetine in treating adolescents dually diagnosed with ADHD and SUD.

This study will last up to 18 weeks. Participants will receive six treatments of manual-driven, cognitive behavioral therapy for substance abuse over at 6 or earlier weeks. Participants and their parents will partake in therapy sessions. Subjects who have completed at least 2 weeks of CBT will be eligible to enter the controlled trial, at which point participants will be randomly assigned to receive either atomoxetine or placebo, which they will take once daily for 12 weeks. At the Week 12 study visit, participants will be assessed for symptoms of ADHD and SUD.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of ADHD
* Current or recent (within the three months prior to study entry) SUD, including marijuana and alcohol abuse
* ADHD CGI-S score of greater to or equal to 4

Exclusion Criteria:

* Any Unstable medical condition
* Recent history of intravenous drug use or cocaine dependence
* Currently abusing ecstasy, cocaine, gamma-hydroxybutyrate, methamphetamine, amphetamine, opioids, phencyclidine, or benzodiazepine
* Mental retardation or organic brain syndrome
* Currently psychotic or history of bipolar disorder
* Currently taking any psychotropic or anti-substance abuse disorder medications
* Current DSM-IV diagnosis of major depression, depressive disorder, or anorexia
* Pregnant or breastfeeding

Primary outcomes:
measure: Symptoms of ADHD and SUD (measured at Week 12)
timeFrame: 12 Weeks (LOCF)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Timothy E. Wilens
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03242122: Evaluation of Carbohydrates
Official title: Evaluation of Carbohydrates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Index
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2017-08-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The study is open-label with a randomized, cross-over design using standard Gl methodology.


Eligibility criteria: Inclusion Criteria:

* Subjects are males or non-pregnant females in good health.
* Subjects must be eligible to receive income in Canada and must demonstrate OHIP or equivalent medical coverage.

Exclusion Criteria:

* Subject with any type of food allergy or with a known history of AIDS, hepatitis, diabetes or a heart condition.
* Subject taking medication, or with any condition which might, in the opinion of the PI either make participation dangerous to the subject or to others or affect the results.

Primary outcomes:
measure: Blood glucose response curve
timeFrame: 0 to 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Glycemic Index Laboratories Inc
state: Ontario
Study officials:
affiliation: Abbott Nutrition
name: Vikkie Mustad, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04546022: GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver
Official title: GSP as an Novel Indicator for Residual Liver Function in Patients With Fatty Liver
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Galactose Single Point (GSP), Residual Liver Function
Keywords: GSP
galactose single point (GSP)
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
Collaborators: name: Cardinal Tien Hospital
name: Tri-Service General Hospital
First posted: 2020-09-11
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The primary objective is to determine the galactose single point (GSP) cutoff values to discriminate subjects with different hepatic function. The secondary objective is to analyze the correlations between GSP and other hepatic function assessment methods among this trial subjects.

Detailed description: Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease, including the potential for progression to nonalcoholic steatohepatitis (NASH), followed by fibrosis and ultimately cirrhosis. The gold standard to evaluate fibrosis in patients with NAFLD is liver biopsy. The investigators aimed to evaluate the clinical utility of using the galactose single point (GSP) test which recommended by the US FDA to quantitatively measure liver function in patients with NAFLD.

Eligibility criteria: Inclusion Criteria:

Subject must fulfill all of the following criteria to be eligible for the study:

1. Male or female with age between 20-80.
2. Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.

Exclusion Criteria:

Any of the following criteria will disqualify the subject from participation:

1. History of serious allergic reaction to galactose and have galactosemia.
2. History of receiving total gastrectomy, subtotal gastrectomy, celiac disease, or small intestinal resection.
3. History of diabetes mellitus.
4. Subjects are children or handicapped people.
5. Subjects with any other reasons considered by the investigator not in the condition to enter into the trial.

Primary outcomes:
measure: Blood concentration of galactose
timeFrame: Sixty minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06167122: Treatment Protocol and Long-Term Outcomes in Craniofacial Fibrous Dysplasia
Official title: Long-term Follow-up and Treatment Protocol for Craniofacial Fibrous Dysplasia From 40-year Data at Chang Gung Memorial Hospital: A Retrospective Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniofacial Fibrous Dysplasia
Keywords: Craniofacial fibrous dysplasia
Optic nerve decompression
Hormone therapy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with craniofacial fibrous dysplasia, and received craniofacial surgery

Brief summary: Craniofacial fibrous dysplasia (CFD) is a nonneoplastic disease characterized by fibro-osseous lesions in the affected bones. Treatment is mainly surgical and is stratified based on four different anatomical zones. This study aimed to evaluate the long-term outcomes and refine the algorithm for CFD.

Detailed description: According to Chen et. al for the appropriate surgical management of FD the craniofacial skeleton can be divided into four zones according to the consideration of facial cosmesis, vital anatomical region and function preserving. The aim of the study was to evaluate the outcome of nearly 40 years long-term follow up cohort group and refine the algorithm of surgical intervention of FD under 4 zones classification.

Eligibility criteria: Inclusion Criteria:

* Received CFD surgical intervention between 1972 and 2019
* Personal interviews: between late 2019 and 2020, covering a postoperative period of over 20 years
* All the surgery were performed by a senior surgeon (Yu-Ray Chen) at Chang Gung Craniofacial Center

Exclusion Criteria:

* Patients who underwent surgical treatment at other institutions during the follow-up period or those who did not return to the craniofacial outpatient department for follow-up and receive computed tomography scans between 2019 and 2020 will be excluded.

Primary outcomes:
measure: Recurrence
timeFrame: Personal interviews with facial bone computed tomography obtained on late 2019 and 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Pang-Yun Chou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02827422: A Prospective, Multicenter Registry With Targeted Temperature Management After Out-of-hospital Cardiac Arrest in Korea
Official title: A Prospective, Multicenter Registry With Targeted Temperature Management After Out-of-hospital Cardiac Arrest in Korea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Out-of-Hospital Cardiac Arrest
Keywords: therapeutic hypothermia
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 1800
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 treated with therapeutic hypothermia after out-of-hospital cardiac arrest.

Brief summary: Therapeutic hypothermia after out-of-hospital cardiac arrest is considered as a standard care. However, optimal candidates, optimal dose, duration, timing of initiation and rate of rewarming is still unknown. The objective of this project is to improve the outcomes for patients after resuscitation from out-of-hospital cardiac arrest treated with therapeutic hypothermia established from the analysis of multicenter registry data.


Eligibility criteria: Inclusion Criteria:

* age of older than 18 years
* out-of-hospital cardiac arrest
* comatose mentality after return of spontaneous circulation (ROSC)
* treated with therapeutic hypothermia, regardless of target temperature

Exclusion Criteria:

* suspected or confirmed to cerebrovascular accident
* poor pre-arrest neurologic status (CPC\>3)
* patients who are terminally ill or for whom intensive care dose not seem to be appropriate
* Do not attempt resuscitation (DNAR) order
* patients with tympanic membrane temperature below 30 degree celsius on admission

Primary outcomes:
measure: survival
timeFrame: 6 months after cardiac arrest
measure: Neurologic Outcome
timeFrame: 6 months after cardiac arrest
measure: Neurologic Outcome
timeFrame: after 6 months
Secondary outcomes:
measure: survival
timeFrame: duration of hospitalization, limit 180 days
measure: neurological outcome
timeFrame: duration of hospitalization, limit 180 days
measure: neurological outcome
timeFrame: duration of hospitalization, limit 180 days
measure: Survival
timeFrame: 1 month after cardiac arrest
measure: neurological outcome
timeFrame: 1 month after cardiac arrest
measure: neurological outcome
timeFrame: 1 month after cardiac arrest
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, The Catholic University of Korea
Study officials:
affiliation: Seoul St. Mary's Hospital, The Catholic University of Korea
name: Kyu Nam Park, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oh JH, Lee DH, Cho IS, Youn CS, Lee BK, Wee JH, Cha KC, Chae MK, Shin J; Korean Hypothermia Network Investigators. Association between acute kidney injury and neurological outcome or death at 6 months in out-of-hospital cardiac arrest: A prospective, multicenter, observational cohort study. J Crit Care. 2019 Dec;54:197-204. doi: 10.1016/j.jcrc.2019.08.029. Epub 2019 Aug 28.
Clinical trial NCT01903122: Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dry Mouth
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-07-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Roxane Laboratories' Cevimeline 30 mg under fasted conditions


Eligibility criteria: Inclusion Criteria:

- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to cevimeline or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax comparison of the pharmacokinetic parameters
timeFrame: 33 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Novum Pharmaceutical Research Services
state: Nevada
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Darin Brimhall, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03054922: Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables
Official title: Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 59
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During major surgical procedures, intravascular volume is maintained with the administration of isotonic fluids such as Lactated Ringers (LR), Normal Saline (NS) or Normosol-R. All three of these fluids are in common clinical use for this purpose. As large volumes of NS may result in a dilutional acidosis and an increasing base deficit, it may cloud clinical decision making when resuscitative efforts are guided by acid-base status on routine arterial blood gas analysis. This is a prospective, randomized study to evaluate changes in acid-base and electrolyte (sodium, potassium, calcium) status with the use of various isotonic fluids for intraoperative resuscitation.


Eligibility criteria: Inclusion Criteria:

* Major surgical procedure requiring arterial access

Exclusion Criteria:

* Comorbid disease process that contraindicates the use of any 1 of the 3 crystalloid solutions.

Primary outcomes:
measure: Change in Base Deficit
timeFrame: During surgery (typically 4-6 hrs in length)
Secondary outcomes:
measure: Change in Sodium
timeFrame: During surgery (typically 4-6 hrs in length)
measure: Change in Potassium
timeFrame: During surgery (typically 4-6 hrs in length)
measure: Change in Ionized Calcium
timeFrame: During surgery (typically 4-6 hrs in length)
measure: Change in pH
timeFrame: During surgery (typically 4-6 hrs in length)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT00765622: Assessment of Pelvic Floor Function in Elderly
Official title: Assessment of Pelvic Floor Function in Women With Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Keywords: Urinary incontinence
pelvic floor
functional evaluation
Lead sponsor: Catholic University of Brasília
Sponsor class: OTHER
First posted: 2008-10-03
Enrollment: 153
Sex: FEMALE
Minimum age (years): 58
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: elderly women

Brief summary: The purpose of this study is to demonstrate the importance of functional assessment of the pelvic floor (AFA) in older women, as prognostic factor for Urinary Incontinence (UI).

Detailed description: Incontinence elderly assessment

Eligibility criteria: Inclusion Criteria:

* Elderly women
* Urinary incontinence

Exclusion Criteria:

* Cesarean surgery

Primary outcomes:
measure: All patients were submitted for review physiotherapeutic through palpation bidigital and quantification of contraction pelvic, was performed using a my feedback of pressure
timeFrame: Only one measure at the begging of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: UC
state: Distrito Federal
Study officials:
affiliation: Catholic University of brasilia
name: Claudia EC Souza, Ms
role: PRINCIPAL_INVESTIGATOR
References: