louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03464175: Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation
Official title: Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation: a Randomized Comparative Scintigraphic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries, Traumatic
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 34
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: The intention is to enroll a specific sample of intubated patients. To compare the effect of respiratory gas conditioning on lung deposition and considering the well-known influences of lung pathology on lung deposition, intubated patients with healthy lungs will be included. Postoperative neurosurgery ventilated patients respond perfectly to this criteria. A previous study including 17 postoperative neurosurgery patients was performed in 2013 with a perfect collaboration between the ICU and the Department of Neurosurgery and Anesthesiology.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Postoperative neurosurgery intubated patients admitted for brain neurosurgery in the ICU (Intensive care neuro-traumatologic and Toxicologic)- With a healthy lung function.
* Signed and dated informed consent should be obtained in accordance of local regulations.

Exclusion Criteria:

* Spine neurosurgery
* History of cardiovascular and pulmonary disease
* Extubation immediately after surgery
* Modification of the allocated humidification technique before or during the nebulization (heated-humidifier deficiency or safety concern)
* Inaccurate quantification of aerosol deposition (i.e., artifacts or overlap of tracheal and pulmonary deposition).

Primary outcomes:
measure: Quantity of aerosol deposition from the nebulizer reservoir to the subject. Measured by Planar scintigraphy.
timeFrame: 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universiataires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Pierre-François Laterre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03807375: The Comparison of the Methods Applied in Bariatric Surgery in Terms of Preoxygenation Time
Official title: Evaluation of the Effect of CPAP and Mask Ventilation on Preoxygenation Time in Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Time to Reach 90% Endtidal Oxygen During Preoxygenation
Keywords: CPAP(Continuous Positive Airway Pressure)
Standard preoxygenation
Lead sponsor: Ankara Diskapi Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study was to evaluate the preoxygenation time by observing patients undergoing preoxygenation with CPAP (Continuous Positive Airway Pressure) and Mask Ventilation in the clinic.

Detailed description: Criteria for inclusion in the study:

Planned elective bariatric surgery under general anesthesia ASA 1-2 class Between 20-50 years 50 patients

1. Group: Patients undergoing CPAP (Continuous Positive Airway Pressure) during preoxygenation will be included.
2. Group: Patients undergoing preoxygenation without CPAP will be included

In both groups, the time from the anesthesia device to the endtidal O2 90% and the endtidal CO2 value in this order will be recorded.

Heart rate, blood pressure, endtidal O2 and CO2 values will be recorded during preoxygenation and after intubation.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:

  1. Patients between the ages of 20 and 50 years
  2. American Society of Anesthesiologists I, II or III
  3. Patients with body mass index of 40 and over

Exclusion Criteria:

1. cardiopulmonary disease
2. patients with previous abdominal or thoracic surgery or cerebrovascular disease
3. story of intracranial hypertension or epilepsy
4. patients with a story of difficult tracheal intubation

Primary outcomes:
measure: Prevention of desaturation during intubation
timeFrame: 5 minutes
measure: prevention of side effects of hypoxia
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Training Research Hospital
Study officials:
References:
citation: Bouroche G, Bourgain JL. Preoxygenation and general anesthesia: a review. Minerva Anestesiol. 2015 Aug;81(8):910-20. Epub 2015 Jun 5.
citation: Nimmagadda U, Salem MR, Crystal GJ. Preoxygenation: Physiologic Basis, Benefits, and Potential Risks. Anesth Analg. 2017 Feb;124(2):507-517. doi: 10.1213/ANE.0000000000001589.
Clinical trial NCT06620575: Evaluation of Predictive Factors for Recurrence of Persistent Atrial Fibrillation After Ablation
Official title: Evaluation of Predictive Factors for Recurrence of Persistent Atrial Fibrillation After Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 542
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who underwent a procedure for persistent atrial fibrillation ablation at Clairval Hospital since January 2014

Brief summary: This is a single-center, retrospective, observational study based on data extracted from the medical records of patients who underwent a procedure for persistent atrial fibrillation ablation.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or older, who has been informed about the research
* Patient who underwent a procedure for persistent atrial fibrillation ablation at Clairval Hospital since January 2014
* Patient for whom data regarding the ablation procedure are available

Exclusion criteria:

* Patient under legal protection, guardianship, or conservatorship
* Patient who has expressed opposition to the use of their medical data (by completing and returning the opt-out form provided)

Primary outcomes:
measure: Recurrence of persistent atrial fibrillation
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Privé Clairval
Study officials:
References:
Clinical trial NCT01017575: Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)
Official title: A Phase 2a Study of Daclatasvir in Combination With Peginterferon Alfa-2a(Pegasys®) and Ribavirin (Copegus®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-11-20
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious


Eligibility criteria: Key Inclusion Criteria:

* Subjects chronically infected with hepatitis C virus (HCV) genotype 1
* HCV RNA viral load ≥ 10\*5\* IU/mL (100,000 IU/mL) at screening
* The current standard of care naïve or non-responder

Key Exclusion Criteria:

* Cirrhosis
* HCC
* Co-infection with hepatitis B virus (HBV), HIV-1 or HIV-2

Primary outcomes:
measure: Percentage of Participants With Extended Rapid Virologic Response (eRVR)
timeFrame: From Week 4 up to Week 12
Secondary outcomes:
measure: Percentage of Participants With Rapid Virologic Response (RVR)
timeFrame: Week 4
measure: Percentage of Participants With a Complete Early Virologic Response (cEVR)
timeFrame: Week 12
measure: Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24
timeFrame: Follow up Week 12, Follow up Week 24
Other outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died.
timeFrame: From Baseline up to 30 days after last dose of study drug
measure: Number of Participants With Grade 3 to 4 Laboratory Abnormalities
timeFrame: From screening up to Week 12 (treatment period)
Locations:
city: Chiba-Shi
country: Japan
facility: Local Institution
state: Chiba
city: Kurume-Shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Okayama-Shi
country: Japan
facility: Local Institution
state: Okayama
city: Osaka-Shi
country: Japan
facility: Local Institution
state: Osaka
city: Osaka-Shi
country: Japan
facility: Local Institution
state: Osaka
city: Musashino-Shi
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02134275: Whole Body Vibration Training for Healthy Body Composition in Young Adults
Official title: Whole Body Vibration Training for Healthy Body Composition in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Gain
Keywords: whole body vibration training
young adult
weight gain
obesity
randomized clinical trial
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the benefits and feasibility of a whole body vibration (WBV) exercise program as a method of preventing weight gain in young adults.


Eligibility criteria: Inclusion Criteria:

1. BMI that is between 22-29.9 kg/m2
2. History of being weight stable (± 2 kg) for three months prior to beginning the intervention
3. Not currently on a prescribed diet plan to lose weight and no plan to begin one
4. Not consistently engaged in physical activity that meets current public health recommendations of 150 minutes of moderate to vigorous physical activity in the previous 6 months
5. Currently enrolled as an undergraduate student in a degree-granting college or university
6. Planning to reside in the Portland Metro area for the duration of the study

Exclusion Criteria:

1. Health condition that would prevent participation in moderate intensity physical activity program.
2. For female participants, pregnancy or plans to become pregnant during the study period (source documentation: self-report on HHQ)
3. Currently smoking/tobacco products or initiation of smoking/tobacco during the study
4. Alcohol consumption exceeding 3 drinks per day or a total of 18 drinks per week

Primary outcomes:
measure: Change in body composition (total body mass, fat-free mass, fat mass, regional fat mass, android/gynoid ratio and % body fat) across baseline, 3 and 6 months
timeFrame: baseline, 3, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU School of Nursing
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Kerri Winters-Stone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01529775: Randomized Study of Osseotite Certain Tapered Prevails vs. Osseotite Certain Tapered
Official title: A Prospective Randomized-controlled Evaluation of the Osseotite Certain Tapered Prevail Implant for the Preservation of Crestal Bone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Edentulism
Tooth Disease
Keywords: partial edentulism
dental implants
Osseotite Certain Prevail Tapered
Osseotite Certain Tapered
Crestal bone level
randomized
clinical study
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 92
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: This study will demonstrate the benefits of platform switching design of the Osseotite dental implant.

Detailed description: The Osseotite Certain Prevail implant with its platform switch feature will demonstrate higher success rate than the non-platform Osseotite Certain implant

Eligibility criteria: Inclusion Criteria:

* patients of either sex and older than 18 years of age
* patients needing at least one dental implant to treat partial edentulism
* patients physically able to tolerate surgical and restorative dental procedures
* patients agreeing to all protocol visits

Exclusion Criteria:

* patients with infection or severe inflammation at the intended treatment sites
* patients smoking greater than 10 cigarettes per day
* patients with uncontrolled diabetes mellitus
* patients with uncontrolled metabolic diseases
* patients who received radiation treatment to the head in the past 12 months
* patients needing bone grafting at the intended treatment sites
* patients known to be pregnant at screening visit
* patients with para-functional habits like bruxing and clenching

Primary outcomes:
measure: Cumulative Success Rate
timeFrame: 3 years
Secondary outcomes:
measure: Crestal Bone Regression
timeFrame: 3 years
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad Finis Terrae
Study officials:
affiliation: Universidad Finis Terrae
name: Manuel Pavez, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02162875: Schistosoma Mansoni in Mwanza Region, Tanzania
Official title: Parasitologic Impact of Different Mass Drug Administration Strategies Against Schistosoma Mansoni in Endemic Areas of Mwanza Region, Tanzania, Where Prevalence is 25% or Above
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schistosoma Mansoni
Keywords: Schistosoma mansoni
treatment
school children
adults
Lead sponsor: DBL -Institute for Health Research and Development
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 37500
Sex: ALL
Minimum age (years): 7
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the strategy for mass drug administration (MDA) which provides the greatest reductions in prevalence and intensity of Schistosoma mansoni in school-aged children after 4 years of intervention.

Detailed description: Intestinal schistosomiasis is caused by the blood-dwelling flatworm Schistosoma mansoni. Despite the increasing focus on the use of praziquantel against schistosomiasis infections for the last three decades many areas in Sub-Saharan Africa still have high prevalences and intensities of schistosomiasis especially among school-age children. This is true for the area of Mwanza Region of Tanzania adjacent to Lake Victoria. The study is a six arm study and includes 150 communities (25 in each arm). From each community 100 school children (aged 9-12 years), 100 first year students (aged 7-8 years) and 50 adults (aged 20-55 years) are included, diagnosed and treated with praziquantel using strategies composing of a mixture of community wide treatment (CWT), school-based treatment (SBT) and years without treatment (-T). The 100 school children provided stool specimens on three consecutive days, while the 100 first year students and 50 adults with few exceptions only provided one specimen. The treatment strategies during the 4 years for the different arms are as follows: Arm 1: CWT, CWT, CWT, CWT; Arm 2: CWT, CWT, SBT, SBT; Arm 3: CWT, CWT -T, -T; Arm 4: SBT, SBT, SBT, SBT; Arm 5: SBT, SBT, -T, -T; Arm 6: SBT, -T, SBT, -T.

Eligibility criteria: Inclusion Criteria:

-All school children and adults who consent to participate can be included

Exclusion Criteria:

-Those not consenting or with any chronic disease not related to schistosomiasis will be excluded

Primary outcomes:
measure: Effect of Mass drug administration on prevalence and intensity of Schistosoma mansoni among children and adults
timeFrame: May -October 2016 (5 months)
Secondary outcomes:
measure: Mass drug administration coverage
timeFrame: May -October 2016 (5 months)
Other outcomes:
measure: Cost of different treatment arm
timeFrame: May-October 2016 (5 months)
Locations:
city: Mwanza
country: Tanzania
facility: National Institute for Mediacal Research
state: Lake Region
Study officials:
affiliation: National Institute for Medical Research, Mwanza Research Centre
name: Safari Kinung'hi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02105675: Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
Official title: Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Castrate-resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Prostate Cancer Metastatic
Keywords: Immunotherapy
Metastatic
Castrate Resistant
Prostate Cancer
Biological
Vaccine
Lead sponsor: Sotio Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-07
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care therapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer


Eligibility criteria: Inclusion Criteria:

* Men aged ≥ 18 years
* Histologically confirmed prostate cancer
* Presence of skeletal metastasis (by CT or PET or MRI)
* Disease progression documented by increasing PSA or two new lesions
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

Exclusion Criteria:

* Confirmed brain and/or leptomeningeal metastases
* Prior chemotherapy for prostate cancer
* Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
* Other uncontrolled intercurrent illness
* Treatment with immunotherapy against PCa
* Clinically significant cardiovascular disease
* Active autoimmune disease requiring treatment

Primary outcomes:
measure: Survival rate
timeFrame: 135 weeks
Secondary outcomes:
measure: Radiographic Progression Free Survival
timeFrame: 135 weeks
measure: Duration to Prostate Specific Antigen (PSA) Progression
timeFrame: 135 weeks
measure: Changes in Quality of Life (QOL) assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
timeFrame: 0, 10, 22, 37, 53, 65 weeks
measure: Changes in Pain assessed by EORTC QLQ-C30
timeFrame: 0, 10, 22, 37, 53, 65 weeks
measure: Incidence of Adverse Events
timeFrame: 135 weeks
Other outcomes:
Locations:
city: Brno
country: Czechia
city: Hradec Kralove
country: Czechia
city: Jihlava
country: Czechia
city: Liberec
country: Czechia
city: Nova Ves pod Plesi
country: Czechia
city: Olomouc
country: Czechia
city: Ostrava
country: Czechia
city: Praha 10
country: Czechia
city: Praha 4
country: Czechia
city: Praha 5
country: Czechia
city: Praha 8
country: Czechia
city: Usti nad Labem
country: Czechia
city: Zlin
country: Czechia
Study officials:
affiliation: Sotio Biotech Inc.
name: Tomas Scheiner, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03544775: Impact of Anesthesiology Interventions on Postoperative Outcomes in Adult Patients Undergoing Shoulder Surgery
Official title: Impact of Anesthesiology Interventions on Postoperative Outcomes in Adult Patients Undergoing Ambulatory Shoulder Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 59644
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This will be a retrospective, population-based, cohort study based in Ontario, Canada. Our study population will include all Ontario residents, aged 18 years and older, who have undergone elective ambulatory shoulder surgery. The study period extends from April 2009 to March 2016.

Brief summary: This retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient outcomes after ambulatory shoulder surgery in adults patients undergoing surgery in Ontario.

Detailed description: First, investigators will validate health administrative data codes to demonstrate the accuracy of Ontario-wide anesthesia type and regional anesthesia interventions using a reference standard (Ottawa Hospital Data Warehouse data). Then, these validated exposures, in combination with validated outcome measures, will be used to examine the impact of anesthesia interventions on patient and health system outcomes for ambulatory shoulder surgery.

Eligibility criteria: Inclusion Criteria:

* Ontario residents
* Aged 18 years and older
* Elective ambulatory shoulder surgery performed in Ontario between April 2009 and December 2016.

Exclusion Criteria:

* Emergency Surgery
* If a patient undergoes multiple elective shoulder surgeries within the time period, only the first surgery will be included for any participant in the study period.

Primary outcomes:
measure: Postoperative Death, Admission, Readmission or Emergency Department Visits
timeFrame: Date of surgery to 7 days (ED visits) and 30 days (readmissions) after surgery or death date, whichever came first
Secondary outcomes:
measure: Health System Costs
timeFrame: Date of surgery to 7 days and 30 days after surgery or death date, whichever came first
measure: Neurology Consultations or Diagnostics
timeFrame: Date of surgery to 90 days after surgery or death date, whichever came first
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, University of Ottawa, Ontario, Canada
name: Daniel McIsaac, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: