louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07022951: The Million Anesthesia Cases Study (MACS) - a Cohort Study of Preoperative Fasting and Perioperative Outcomes
Official title: The Million Anesthesia Cases Study (MACS) - Retrospective and Prospective Characterization of Perioperative Fasting Practices and Their Effects on Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
Sedation
Monitored Anesthesia Care
Procedure
Surgery, Day
Surgery
Surgery Scheduled
Fasting Before Operation
Aspiration; Gastric Contents, Anesthesia
Keywords: preoperative fasting
perioperative pulmonary aspiration
perioperative complications
postoperative nausea and vomiting
perioperative hypoglycemia
perioperative hyperglycemia
perioperative hypotension
myocardial injury after noncardiac surgery
perioperative acute kidney injury
clear liquid fasting
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 1200000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will include all anesthesia cases at participating institutions.

Brief summary: Perioperative fasting has historically been viewed as a low-risk intervention. However, preliminary data indicate that perioperative loss of nutrition and fluids is likely harmful. This study intends to characterize perioperative fasting practices and their potential effects on clinical outcomes through possible effects on patient well-being (anxiety, hunger, thirst), physiology (hypovolemia, hypotension), perioperative aspiration, etc. We hypothesized that in addition to known adverse effects on patients' well-being, prolonged preoperative fasting adversely affects circulating blood volume-related (hypotension, decreased urine output etc.) and glucose metabolism-related (e.g., hypo/hyperglycemia) perioperative physiology.

Additional knowledge on the potential adverse effects of preoperative fasting will inform preoperative fasting policies and research interventions that are relevant to hundreds of millions of patients subjected to preoperative/preprocedural fasting worldwide each year.


Eligibility criteria: Inclusion Criteria:

* Diagnostic or therapeutic procedure with anesthesia care (general anesthesia, regional anesthesia, sedation, or a combination of the above)

Exclusion Criteria:

* Not receiving anesthesia care
* Lack of medical record data in Epic electronic medical record system

Primary outcomes:
measure: Incidence and severity of fasting-related perioperative complications: pulmonary aspiration; patient well-being (anxiety, hunger, thirst); circulating blood volume-related complications (hypotension, myocardial and kidney injury); dysglycemia.
timeFrame: Perioperative period - while patient is located in the preoperative area, procedure area, or recovery area.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mass General Brigham
state: Massachusetts
Study officials:
References:
Clinical trial NCT03392051: Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Clopidogrel
Official title: Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses Of ISIS 681257 40 mg Subcutaneous Injections On The Pharmacokinetics And Pharmacodynamics Of Clopidogrel In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Elevated Lipoprotein(a)
Cardiovascular Diseases
Lead sponsor: Akcea Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-01-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This is a single center, open label, single sequence, two treatment, two-period drug-drug interaction study to evaluate the effect of multiple doses of ISIS 681257 on the pharmacokinetics of multiple doses of clopidogrel


Eligibility criteria: Inclusion Criteria:

* Motivated and available for duration of study and willing to adhere to protocol
* Males who are unable to procreate or agree to contraception throughout study
* Females who are postmenopausal or surgically sterile
* BMI between 18.5 and 30 kg/m2
* Weighing greater than or equal to 50kg
* Normal lab results
* No known diseases or significant findings on physical exam

Exclusion Criteria:

* Females of childbearing potential
* Reactions/infection at injection site
* Hypersensitivity to any drugs or similar drugs to those used in the study
* Conditions or disease that may interfere with study drug
* Any significant diseases
* Known history or familial history of bleeding disorders
* Drug dependency or abuse
* Illness within 28 days
* Previous exposure to other investigational drug within 28 days
* Blood donations within 28 days

Primary outcomes:
measure: Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the PK of multiple oral doses of clopidogrel in healthy adult subjects
timeFrame: 55 days
Secondary outcomes:
measure: Evaluate the safety of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections when co-administered with multiple oral doses of clopidogrel in healthy adult subjects
timeFrame: 55 days
measure: Evaluate the effect of multiple doses (2 doses) of ISIS 681257 40 mg subcutaneous injections on the pharmacodynamics (antiplatelet activity) of multiple doses of clopidogrel in healthy adult subjects
timeFrame: 55 days
Other outcomes:
Locations:
city: Mount Royal
country: Canada
facility: Clinical Site
state: Quebec
Study officials:
References:
Clinical trial NCT02839551: Optimal Doses for Drug Provocation Tests to Beta-lactams
Official title: Optimal Step Doses for Drug Provocation Tests to Prove Beta-lactam Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Hypersensitivity
Keywords: Betalactams
Drug hypersensitivity
Drug provocation test
Reactive dose
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 1252
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Drug provocation tests (DPT) are widely in case of suspicion of drug hypersensitivity (and in the absence of contraindications), but there are no standardized protocols and most groups use hypothesis (clinically-driven) protocols.

investigators used 20 year experience in drug hypersensitivity to analyse retrospectively 171 patients (accounting for 182 positive DPT to beta-lactams). Using survival analysis, they identified optimal doses to include in a data-driven protocol. This data-driven protocol will be applied to new prospective patients, to test its safety and benefits (gain in time, hospital and patient benefits).


Eligibility criteria: Inclusion Criteria:

* patients with positive Drug Provocation Test (DPT) to beta-lactams

Exclusion Criteria:

* contra-indications to DPT
* refusal of participation
* vulnerable patients according to French regulation

Primary outcomes:
measure: Assessment of the new simplified drug provocation test
timeFrame: up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
References:
Clinical trial NCT03810651: Pencil Beam Scanning in Patients With Renal Tumors
Official title: Pilot Study of Pencil Beam Scanning Proton Beam Radiation Therapy in Patients With Renal Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Renal Tumor
Wilms Tumor
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 28
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study to assess acute toxicity in patients receiving flank irradiation using proton therapy for renal tumors.

Detailed description: Patients with renal tumors including Wilms and clear cell sarcoma of the kidney (CCSK) are treated with multimodality therapy which may include surgery, chemotherapy, and radiation. While long-term disease control is excellent, these patients remain at risk for early and late toxicities partially from radiation. There have been no significant changes to traditional photon radiation fields, which encompass the post-operative bed, anterior abdomen, and vertebral body. Proton beam radiation using pencil beam scanning, which is characterized by Bragg peak dose deposition and high conformality of dose to target regions, is ideally suited to treat the retroperitoneum. This pilot study evaluates pencil beam scanning proton therapy (PBS-PT) to:

* result in low acute gastrointestinal toxicity in patients receiving radiation therapy for renal tumors as measured by laboratory evaluations, clinician-assessed, and patient reported health related quality of life outcomes
* decrease the duration of radiation therapy
* compare doses to organs at risk (OARs) using PBS-PT as compared to traditional photon fields

Eligibility criteria: Inclusion Criteria:

* Less than 30 years of age
* Diagnosis

  a. Any patient with Wilms tumor or clear cell sarcoma of the kidney who would require radiation therapy as standard of care including
  1. Any patient with favorable histology (FH), stage III disease
  2. Any patient with focal or diffuse anaplasia
  3. Any patient with CCSK
* The patient is a candidate for external beam radiotherapy based on standard of care for treatment of Wilms tumor or CCSK

Exclusion Criteria:

* Prior radiotherapy to the region of the study cancer
* Chemotherapy administered for diagnosis of Wilms tumor or CCSK
* Pregnant or breastfeeding

Primary outcomes:
measure: Occurrence of any non-hematologic toxicity that occurs within 90 days following the start of proton therapy assessed with with NCI Common toxicity criteria (CTC Version 4.0) grades].
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Christine Hill-Kayser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02804451: Intubation During Cardiopulmonary Resuscitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Intubation
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study was to compare the intubation time and effectiveness, the grade of larynx visibility, and the ease of intubation in adults performed by nurses using 4 devices: a Macintosh blade laryngoscope (MAC), and a TruView EVO2 (EVO2), TruView EVO2 PCD (PCD), and ETView SL (ETView) laryngoscope, in simulated CPR settings with and without CC.


Eligibility criteria: Inclusion Criteria:

* had not received any training in endotracheal intubation with videolaryngoscopy before the study,
* had nursing specialization in anaesthesiology or emergency medicine,
* presented with no wrist or low back diseases or pregnancy.

Exclusion Criteria:

* not meet the above criteria.

Primary outcomes:
measure: time to the first ventilation attempt
timeFrame: 1 day
Secondary outcomes:
measure: time to visualize the larynx
timeFrame: 1 day
measure: time to introduce the endotracheal tube through the vocal cords
timeFrame: 1 day
measure: success rate
timeFrame: 1 day
measure: degree of larynx visibility
timeFrame: 1 day
measure: ease of intubation technique
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw, Department of Emergency Medicine
state: Masovia
Study officials:
affiliation: Medical University of Warsaw
name: Lukasz Szarpak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kurowski A, Szarpak L, Truszewski Z, Czyzewski L. Can the ETView VivaSight SL Rival Conventional Intubation Using the Macintosh Laryngoscope During Adult Resuscitation by Novice Physicians?: A Randomized Crossover Manikin Study. Medicine (Baltimore). 2015 May;94(21):e850. doi: 10.1097/MD.0000000000000850.
Clinical trial NCT01241851: Effect of Acute Exercise on Cognitive Functions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Cognitive Function in Elderly
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: The Zinman College for Physical Education and Sport Exercise, Wingate Institute
First posted: 2010-11-16
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To determine whether acute aerobic exercise versus resistance exercise effects cognitive function among older adults.


Eligibility criteria: Inclusion Criteria:

* Exercise at least 2 times a week Able to sign informed consent Able to perform ergometric exam Above 40 years old

Exclusion Criteria:

* Smoking
* Suffering psychiatric or neurologic illness
* No medication for chronic illness that could effect cognitive function
* Problems with cognitive functioning after head trauma
* Long-term hospitalization within the past 3 months
* Inability to use computer because of vision or motor problems
* Pregnancy

Primary outcomes:
measure: Level of executive function
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Zinman College, Wingate Institute
Study officials:
References:
Clinical trial NCT01605851: GORE® Septal Occluder European Union Clinical Evaluation
Official title: GORE® Septal Occluder EU Clinical Evaluation: A Study to Evaluate Clinical Success and Performance in the Treatment of Transcatheter Closure of Patent Foramen Ovale (PFO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Closure; Foramen Ovale
Keywords: PFO
closure
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2012-05-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of Patent Foramen Ovale (PFO).


Eligibility criteria: Subjects with a PFO less than or equal to 17mm

Primary outcomes:
measure: To evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of PFO
timeFrame: 6 months
Secondary outcomes:
measure: Additional Clinical Success evaluated during the procedure and 6 months post-procedure
timeFrame: 6 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Berlin
country: Germany
facility: German Heart Center
city: Freiburg
country: Germany
facility: University Medical Center of Freiburg
city: Heidelberg
country: Germany
facility: Heidelberg University Hospital
city: Munich
country: Germany
facility: German Heart Center
city: San Donato
country: Italy
facility: Hospital Group of San Donato
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals
Study officials:
References:
Clinical trial NCT01678651: Embryo Kinetics and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH
Official title: Embryo Kinetcis From Embryos Deriving From Egg Donation Cycle With Different Stimulation Protocol: Recombinant FSH vs Human FSH
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Embryo Kinetics
Keywords: time-lapse, FSH, kinetics
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2012-09-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different kinetics markers have been proposed to select embryos with higher implantation rates. The effect of external factors on these markers, such as the stimulation protocol should be analyzed. There are two different types of FSH that are commonly used for in vitro fertilization (IVF) in egg donation cycles, recombinant FSH and human FSH. The effect of each kind of hormone on embryo kinetcis is still unknown. The aim of this study is to observe if there is a difference in embryo kinetics and morphology as well as oocyte morphological parameters between the two types of FSH and therefore to analyze if such markers can be used despite of the stimulation protocols chosen.


Eligibility criteria: Inclusion Criteria:

•Egg donation cycles with more than 8MII in oocyte retrieval day

Exclusion Criteria:

* Male factor
* Uterine malformations
* genetic alterations

Primary outcomes:
measure: time of cell cleavage
timeFrame: February 2012
Secondary outcomes:
measure: Embryo and oocyte morphology
timeFrame: February 2012
measure: Outcome rates (implantation, pregnancy and miscarriage rate)
timeFrame: February 2012
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Insituto Valenciano de Infertilida
Study officials:
References:
Clinical trial NCT02574351: Study of T-Regulatory Cells in Asthma
Official title: Study of T-Regulatory Cells in Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2015-10-12
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females in good health between the ages of 18-50, with or without asthma.

Brief summary: To study whether the immune response as directed by regulatory T cells is different between obese asthmatics, normal weight asthmatics and healthy controls.

Detailed description: The investigators hypothesize that the increase in asthma severity in obese patients is, at least in part, related to a defective number or function of regulatory T cells (Tregs). That is in the obese asthmatic subject a defective Treg profile would augment the inflammation of asthma (a synergistic effect). Alternatively, that Treg dysfunction in obesity might affect asthma independently (an additive effect). To test these hypotheses, the investigators plan to conduct an observational controlled study to compare Treg profile in obese and normal-weight individuals with and without asthma.

This is an exploratory study to investigate the following:

1. To determine whether Treg number and function differs between obese and normal-weight individuals with and without asthma.
2. To determine whether serum leptin levels differ between obese and normal-weight individuals with and without asthma.

Eligibility criteria: Inclusion Criteria:

1. Obese asthmatics
2. Normal weight asthmatics
3. Healthy obese
4. Health non-obese

Asthmatic subjects will be recruited:

1. If they have a physician diagnosis of adult onset asthma (asthma diagnosed after the age of 18).
2. If they have stable disease without exacerbation, physician or emergency department visits, or change in asthma medication for the past 4 weeks, inhaled steroids will be allowed.

Non asthmatic subjects

1. Will not have had a prior diagnosis of asthma,
2. Have no history of atopy.
3. Have no history of lung diseases.

Exclusion Criteria:

1. \> 10 pack year smoking history, or currently smoking
2. Pulmonary disease other than asthma.
3. History of heart disease
4. Weight loss greater than 10 kg, or greater than 10% initial body weight within the past 3 months.
5. Any agents that could potentially alter the inﬂammatory system such as thiazolidinedione, a statin, or oral steroid therapy.

Primary outcomes:
measure: Difference of treg and serum leptin levels among obese and normal weight individuals with and without asthma.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: North Shore LIJ Health System
state: New York
Study officials:
affiliation: North Shore
name: Rubin Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01409551: Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions.
Official title: Video-assisted Hyperthermic Pleural Chemoperfusion Versus Bed-side Talc Slurry Pleurodesis for Refractory Malignant Pleural Effusions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety of Intervention
Efficacy of Intervention
Cost Effectiveness
Keywords: Pleural effusion
VATS
hyperthermia
thoracostomy
pleurodesis
Lead sponsor: Theagenio Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2011-08-04
Enrollment: 60
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.

Detailed description: The study compares prospectively two groups of patients with refractory maignant pleural effusion. Group A consists of patients undergoing video-assisted hyperthermic pleural chemoperfusion (with a pump machine) and group B includes patients undergoing bed-side tube thoracostomy and talc slurry pleurodesis.

Eligibility criteria: Inclusion Criteria:

* Recurrent symptomatic malignant pleural effusion
* No prior intrapleural therapy
* Abscence of bronchial obstruction or fibrosis preventing lung reexpansion
* No systemic chemotherapy immediately prior to or during the first 30-day interval following pleurodesis

Exclusion Criteria:

* Poor Karnofsky Performance Status

Primary outcomes:
measure: Recurrence of pleural effusion
timeFrame: 2 months following intervention
Secondary outcomes:
measure: Morbidity
timeFrame: Postoperative period (7 days following intervention)
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Thoracic Surgery Department, Theagenio Cancer Hospital
Study officials:
affiliation: Theagenio Cancer Hospital
name: Nikolaos Barbetakis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: