louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06164886: Information Flow of Waiting List for Scheduled Surgical Admissions
Official title: Information Flow of Waiting List for Scheduled Surgical Admissions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chirurgical Intervention
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 507
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: all adult patients placed on the waiting list with the NHS for surgery scheduled at the centre

Brief summary: Definition and experimentation of the aforementioned information flow within the Regions participating in the three-year project, a Technical Subgroup was identified on a voluntary basis in charge of defining the design and following the experimental operational phases


Eligibility criteria: Inclusion Criteria:

* all adult patients

Exclusion Criteria:

* Minor patients

Primary outcomes:
measure: Verification of the completeness of the data entered within the flow to guarantee ex Ante monitoring of the waiting list for scheduled surgical hospitalization
timeFrame: At baseline (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: BO
Study officials:
References:
Clinical trial NCT02051686: Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid
Official title: Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid: A Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acetabulum Fractures
Keywords: Acetabulum Fractures
Pelvic Ring Injuries
Tranexamic Acid
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 88
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 is investigating the use of tranexamic acid (TXA) in patients with pelvis and/or hip socket fractures that require surgery. TXA is FDA-approved in patients with hemophilia for short-term use to reduce hemorrhage and the need for replacement blood during tooth extraction. However, it has also been used extensively in severely injured patients after major trauma and during elective hip and knee replacements. Previous studies indicate TXA may reduce blood loss and the need for blood transfusions while being safe for use in most patients. TXA is fairly inexpensive and easy to obtain.

The purpose of this study is to determine if TXA will make surgery in patients with pelvis and/or hip socket fractures safer and more cost efficient.

Detailed description: Study candidates will be identified as they present to the University Hospital emergency room and will be recruited for enrollment. Randomization will occur by electronic randomization software. Prior to surgery, the pharmacy will be notified of an enrolled patient and will be responsible for randomization and creating either a placebo intravenous dose or a treatment study dose. Both study groups will receive the standard of care treatment for intra-operative hemorrhage control.

Eligibility criteria: Inclusion Criteria:

* Adult patients (18 years of age or greater) with acetabulum fractures and/or pelvic ring injuries that require operative fixation via an open surgical approach

Exclusion Criteria:

* Revision surgery
* Surgery occurring more than 2 weeks post-injury
* History of blood dyscrasia or renal insufficiency
* History of any thromboembolic disease
* Pregnancy or nursing, color vision defects
* History of retinal detachment/degeneration
* Intracranial hemorrhage
* Hypersensitivity to tranexamic acid
* Contraceptive Use (estrogens/progestins)
* FEIBA (anti-inhibitor coagulant complex) use

Primary outcomes:
measure: Intra-operative Blood Loss
timeFrame: Day of Surgery
Secondary outcomes:
measure: Number of Participants That Required an Allogenic Transfusion
timeFrame: Perioperative (hospitalized period)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Brett D Crist, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04868786: Pharmacokinetics and Pharmacodynamics of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplantation
Official title: Population Pharmacokinetic and Pharmacodynamic Model-based Dosing Strategy of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplantation(HSCT) Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hematopoietic Stem Cell Transplantation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Food and Drug Safety Evaluation (Republic of Korea)
First posted: 2021-05-03
Enrollment: 20
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is an investigator-initiated clinical trial to analysis population pharmacokinetic characteristics and investigate appropriate pediatric dose of mycophenolate mofetil in pediatric hematopoietic stem cell transplantation patients.


Eligibility criteria: Inclusion Criteria:

* Patients who had mycophenolate treatment at least 3 days for immunosuppressant after allogenic hematopoietic stem cell transplantation
* Patients age \<18 years
* Written Study Informed consent and/or assent from the patient, parent, or guardian

Exclusion Criteria:

* Known hypersensitivity to mycophenolate mofetil or similar class of drug substance
* Patients in medically critical condition such as severe infection or unstable vital signs
* Any condition that would, in the Investigator's judgment, interfere with full participation in the study
* Patients with hypoxanthine-guanine phosphoribosyltransferase deficiency(HGPRT) such as Lesch-Nyhan or Kelley-Seegmiller syndrome)

Primary outcomes:
measure: Pharmacokinetics parameter of melphalan
timeFrame: pre dose, post 1 hour, post 2 hour, post 6 hour
measure: Pharmacokinetics parameter of melphalan
timeFrame: pre dose, post 1 hour, post 2 hour, post 6 hour
measure: Pharmacokinetics parameter of melphalan
timeFrame: pre dose, post 1 hour, post 2 hour, post 6 hour
measure: Pharmacokinetics parameter of melphalan
timeFrame: pre dose, post 1 hour, post 2 hour, post 6 hour
measure: Pharmacokinetics parameter of melphalan
timeFrame: pre dose, post 1 hour, post 2 hour, post 6 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyoung Jin Kang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04446286: Bicentric Study on the Use of ECMO-VV or VA for Severe ARDS Associated With Covid-19
Official title: Bicentric Study on the Use of ECMO-VV or VA for Severe ARDS Associated With Covid-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Keywords: Respiratory Distress Syndrome
SARS-CoV-2
Extracorporeal membrane oxygenation
ECMO-VV
ECMO-VA
Veno-venous ECMO
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a COVID-19 diagnosis by RT-PCR

Brief summary: Describes the cohort of patients receiving ECMO-VV or ECMO-VA in the management of severe ARDS refractory to SARS-CoV-2 in the Strasbourg and Louvain centres


Eligibility criteria: Inclusion Criteria:

* Patient over the age of 18;
* Diagnostic COVID-19 by RT-PCR;
* Hospitalisation in resuscitation for the management of complications related to COVID-19
* Implanted ECMO-VV or VA during hospitalisation;
* Patient agreeing to participate in the study

Exclusion Criteria:

* Sujet who has expressed opposition to participating in the study.
* Sujet under guardianship or trusteeship
* Sujet under safeguard of justice

Primary outcomes:
measure: Retrospective description of effect of the ECMO-VV or ECMO-VA in the management of severe ARDS refractory in patients of the Strasbourg and Louvain centres with covid-19
timeFrame: files analysed retrospectily from March 1st, 2020 to August 1st, 2020 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Thoracique Nouvel Hôpital Civil Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT01885286: Pilot Trial of Novel Circumcision Device
Official title: Simple Circumcision Device: Proof-of-Concept for a Single-visit, Adjustable Device to Facilitate Safe Adult Male Circumcision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safe Circumcision
Keywords: circumcision
HIV prevention
Lead sponsor: VA Puget Sound Health Care System
Sponsor class: FED
Collaborators: name: University of Washington
First posted: 2013-06-24
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators are testing a novel surgical device to facilitate safe circumcision among adult males. The investigators hypothesize that this device will allow non-medical providers to perform safe surgical circumcision without adverse events.

Detailed description: Objective: To conduct a proof-of-concept study to determine the potential utility of a novel, adjustable single-visit, disposable device to facilitate rapid adult circumcision.

Design: Prospective pilot trial of a novel surgical device Setting: Tertiary care Veterans Administration medical center Patients: 5 adult males Interventions: Circumcisions performed by junior trainees using an adjustable, single-size surgical-assist device constructed by the University of Washington Applied Physics Laboratory.

Main Outcome Measure(s): The attending surgeon and trainees completed standardized forms after each procedure to assess technical problems and ease of use. Follow-up visits were scheduled to evaluate adverse events, post-operative pain, cosmetic outcomes and participant satisfaction at 3, 8, 30 and 90 days post-operatively.

Eligibility criteria: Inclusion

1. Uncircumcised males
2. Aged\>18
3. Sexually active
4. No plans for moving in next 6 months
5. Consent to participate

Exclusion

1. History of a bleeding disorder
2. History of a documented concurrent STI of appearance of an STI on initial physical exam
3. Keloid formation or other condition that might unduly increase risk of elective surgery
4. Asprin, anti-coagulants or other clinical contra-indications

Primary outcomes:
measure: Efficacy, injury rate, conversion to standard method rate and cosmetic outcomes of novel surgical device
timeFrame: 90 days
Secondary outcomes:
measure: Time of circumcision
timeFrame: 1 day
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Veterans Administration Puget Sound Health Care System
state: Washington
Study officials:
affiliation: University of Washington/Seattle Puget Sound VA Health Care System
name: John N Krieger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: James M Hotaling, MD MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04854486: Impact of GSE and Xylitol (Xlear) on COVID-19 Symptoms and Time to PCR Negativisation in COVID-19 Patients
Official title: Impact of GSE and Xylitol (Xlear) in Symptoms and Time to PCR Negativisation of Patients With Acute COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Covid19
Keywords: intranasal spray
Covid19
Lead sponsor: Larkin Community Hospital
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo controlled
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to ascertain the impact of GSE and Xylitol (XLEAR) in decreasing the time of negativisation in PCR testing in patients with COVID-19.


Eligibility criteria: Inclusion Criteria

* Adults of ages 18 to 90 years of both sexes
* With positive SARS-CoV-2 carriage confirmed by nasopharyngeal PCR
* Signed informed consent
* 1- Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test
* 2- Moderate symptoms: Respiratory symptoms such as cough, mild shortness of breath with mild oxygen desaturation(room air SpO2 \<92% and \>88% or \<88% corrected to \>92% with 2lt of oxygen)

Exclusion Criteria

* Patients with Severe symptoms: Hypoxia (SpO2 \<88% not corrected by 2 lt nc oxygen) plus severe shortness of breath (excluded)
* Patient with very low viral load (threshold cycle \[Ct\] \> 25 per PCR).
* Known hypersensitivity to one of the constituents, particularly to xylitol or GSE
* Under 18 years of age
* Women of childbearing age who are pregnant, breastfeeding mothers, and intend to become pregnant during the study period; unwilling/unable to take a pregnancy test.
* Unable to provide informed consent or decline to consent or unwillingness to adhere to the Standard of Care protocol.
* Patients with severe symptoms -Hypoxia (SpO2 \<88% not corrected by 2 liter non- concentrated oxygen) plus severe shortness of breath
* History of immunodeficiency or are currently receiving immunosuppressive therapy.
* Have had a planned surgical procedure within the past 12 weeks.
* Already part of this trial, recruited at a different hospital.
* Patient unable to perform oro-nasopharyngeal decolonization
* Patients with acute exacerbation of severe comorbidities like heart disorders Chronic Obstructive Pulmonary Disease (COPD), Heart Failure New York Heart Association (NYHA) Class 3 and 4 and/or diseases with severe oxygenation problems
* Patients on Remdesivir and/or other clinical trials.

Primary outcomes:
measure: Change of time to negativisation via PCR
timeFrame: Baseline and 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Larkin Community Hospital Palm Springs Campus
state: Florida
city: Miami
country: United States
facility: Larkin Community Hospital
state: Florida
Study officials:
References:
Clinical trial NCT02696486: Exercise Training Effect in Patients With HF and PEF
Official title: Exercise Training Effect on Quality of Life and Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: MultiCare Health System Research Institute
Sponsor class: OTHER
Collaborators: name: Henry Ford Hospital
First posted: 2016-03-02
Enrollment: 16
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this is to develop and implement a pilot study that will demonstrate the ability to recruit, enroll, retain, conduct exercise training, and collect pre and post outcomes on the effect of exercise training on quality of life (QOL) and exercise capacity in patients with a diagnosis of heart failure with preserved ejection fraction (HFPEF).


Eligibility criteria: Inclusion Criteria:

* Age \> 55 years (Interested in capturing mean ages close to age 65 as many HF initiatives are based on this age group and HF development increases with aging).
* Diagnosis of HFPEF stable NYHA Stage II- III with an EF of ≥ 45%
* Stabilized on cardiac medications and post hospitalization \> 4 weeks
* Ability to participate in exercise testing and training.
* Referral from Cardiologist or primary care physician.

Exclusion Criteria:

* Unstable Angina
* Uncontrolled diabetes
* Moderate to severe aortic stenosis
* Uncontrolled hypertension Systolic BP\>150 mm Hg or Diastolic BP \>100 mm Hg
* Valvular heart disease
* Untreated coronary artery stenosis \>50%
* Arrhythmias
* Pulmonary disease/COPD
* Dementia or cognitive impairment
* VAD or Transplant planned in next 6 months.
* Current or recent participation in a Cardiac Rehab program within the last six months.

Primary outcomes:
measure: Change in Quality of Life (QOL) score pre and post exercise training (ET).
timeFrame: 9 weeks
Secondary outcomes:
measure: Change in exercise capacity/tolerance pre and post ET using Cardiopulmonary Exercise Testing.
timeFrame: 9 weeks
measure: Demonstrated ability to coordinate patient transition from clinic to home or YMCA partnership based exercise program with weekly staff follow-up within the study timeline.
timeFrame: 9 weeks
measure: Capture 90 day hospital readmission data starting with study enrollment date and within the participants' study timeline.
timeFrame: 90 days
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: MultiCare Health System
state: Washington
Study officials:
References:
citation: Bean G, Mou J, Pflugeisen B, Olsen L, Hoag S, Silva A, Ball AL, Lee T. Exercise Training in Patients With Heart Failure With Preserved Ejection Fraction: A Community Hospital Pilot Study. J Cardiovasc Nurs. 2021 Mar-Apr 01;36(2):124-130. doi: 10.1097/JCN.0000000000000737.
Clinical trial NCT00018486: Epidemiology of Hearing Loss in Diabetic and Non-Diabetic Veterans
Official title: Epidemiology of Hearing Loss in Diabetic and Non-Diabetic Veterans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Tinnitus
Hearing Loss
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The purpose of this study is to determine if individuals with diabetes are at increased risk of hearing impairment or tinnitus (the perception of ringing or noises in the ears or head). An important goal of this research is also to obtain a better understanding of possible interactions between hearing disorders and other chronic conditions, such as diabetes. Participation in this research will be for a few hours only, to be scheduled at the participant's convenience and according to the testing schedules of the different clinics involved.


Eligibility criteria: Any participants over 21 years of age and under 80 who do not have an end-stage disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
Study officials:
References:
Clinical trial NCT01682486: BIP ETT Clinical Tolerability, Safety and Performance Study
Official title: Evaluation of Tolerability, Safety and Performance of BIP Endotracheal Tubes With Bactiguard Coating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Intubation During Surgery
Hospital Acquired Infections
Keywords: Medical device
Endotracheal Tube(s), ETT
Bactiguard Coated ETT
Tolerability
Safety
Performance
Bacterial colonization on ETT surface
Hospital Acquired Infections, HAI
Ventilator Associated Pneumonia, VAP
Lead sponsor: Bactiguard AB
Sponsor class: INDUSTRY
First posted: 2012-09-11
Enrollment: 30
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 objective of the study is to determine Bactiguard coated BIP Endotracheal tube´s tolerability, safety and performance and compare it to a standard un-coated Endotracheal tube.


Eligibility criteria: Inclusion Criteria:

* adult men and women \>=18 years of age
* are, in opinion of the investigator able to communicate with and understand the trial personnel and comply with the requirements of the trial (e.g. fill in questionnaire)
* requiring endotracheal intubation \>=3 h for elective surgery of upper gastrointestinal tract with a tube size of 7 or 8
* has signed informed consent

Exclusion Criteria:

* known transmissive blood disease
* known multiresistant bacterial colonization
* current and continuous treatment by immunomodulating therapies - e.g. systemic (or inhalation) use of cortisone or NSAIDS
* ongoing respiratory infection

Primary outcomes:
measure: Tolerability assessment by using a symptom questionnaire (QLQ-H&N35) before and after surgery. Evaluation of tracheal mucosa directly during surgery and after the end of study by using photos.
timeFrame: Change from Baseline in symptoms and tracheal mucosa after surgery of expected average length of 5 hours
Secondary outcomes:
measure: Overall assessment of safety (device related adverse events and any problems in post postoperative course)
timeFrame: Participants will be followed on the surgery day and the day after surgery
measure: Overall assessment of device performance
timeFrame: The performance will be followed during surgery of an expected average duration of 5 hours
Other outcomes:
measure: Develop a method for surrogate performance evaluation by microbial colonization testing of bacteria from the ETT surface
timeFrame: Microbial testing up to 1 day after surgery
Locations:
city: Huddinge
country: Sweden
facility: Karolinska University Hospital
state: Stockholm
Study officials:
affiliation: Karolinska University Hospital
name: Sigridur Kalman, MD PhD Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjorling G, Johansson D, Bergstrom L, Jalal S, Kohn I, Frostell C, Kalman S. Tolerability and performance of BIP endotracheal tubes with noble metal alloy coating--a randomized clinical evaluation study. BMC Anesthesiol. 2015 Dec 1;15:174. doi: 10.1186/s12871-015-0156-z.
Clinical trial NCT00643786: Interest of Re-oxygenation After Inhalation of 50% Nitrous Oxide / 50% Oxygen Premix in Dental Cares
Official title: Validation of a Kalinox's Administration Protocol for Dental Cares : Interest of Re-oxygenation and Pollution Control
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dental Cares Under Kalinox's Inhalation
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 128
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The usefulness of re-oxygenation after inhalation of 50% nitrous oxide and 50% oxygen premix (Kalinox 170 bar) during dental care is studied and the pollution resulting from administration of Kalinox is also investigated.


Eligibility criteria: Inclusion Criteria:

* From 1 year old
* anxious or phobic patients
* very young children requiring selective dental cares
* mental deficient patients
* ASA 1 or ASA 2 patients

Exclusion Criteria:

* ASA 3 or ASA 4 patients
* contraindication linked to the experimental product
* patients with mental disorder incompatible with the motory test
* patients that have received anxiolytic treatment less than 2 hours before the dental care

Primary outcomes:
measure: Measurement of SpO2
timeFrame: In continuous
Secondary outcomes:
measure: Analysis of ambient air pollution by nitrous oxide and patient's acceptance
timeFrame: In continuous
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: UFR Odontologie Equipe d'accueil 3847
Study officials:
References: