louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06148701: Preoperative Anesthesia Automatic System:a Retrospective Cohort Study
Official title: The Preoperative Anesthesia automatiC systeM for triAge and screeNing (PACMAN) as a Model for Recognition of Patients Who May Screened by Phone: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Procedure, Unspecified
Anesthesia
Assessment
Keywords: Anaesthetists / Health Care Surveys / Preoperative Care / Triage
Lead sponsor: Jeroen Bosch Ziekenhuis
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 1019
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: Patients scheduled for all kind of surgical procedures except cardiac surgery and intracranial surgery

Brief summary: To evaluate of PACMAN triage system is able to discern patient who may be safely screened by phone

Detailed description: PACMAN triage system consists of a health questionnaire and an algorithm. Patient were called up by registered nurses and asked to answer the questionnaire. Patients answers were applied to PACMAN algorithm to determine what kind of screening patient should receive: in person or by phone.

Eligibility criteria: Inclusion Criteria:

* \>18 years old, scheduled for elective clinical interventions under procedural sedation and all types of elective medium or low risk surgery with anaesthetic guidance, as defined by the European Society of Anaesthesia (ESA) guidelines.

Exclusion Criteria:

* \<18 years. Patients scheduled for emergency and high-risk surgery were excluded as the policy of our department dictates that these patients must always be seen in person, according to ESA guidelines.

Primary outcomes:
measure: Reduction of the number of in person consultations
timeFrame: between start inclusion and 6 months after start inclusion
Secondary outcomes:
measure: Reliability of PACMAN
timeFrame: between start inclusion and 6 months after start inclusion
measure: Patients outcome
timeFrame: between start inclusion and 6 months after start inclusion
measure: Cost-effectiveness
timeFrame: between start inclusion and 6 months after start inclusion
Other outcomes:
Locations:
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
state: Brabant
Study officials:
affiliation: Jeroen Bosch Hospital, 's Hertogenbosch The Netherlands
name: Barbe Pieters, Dr.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02302001: Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain
Official title: Breast Augmentation Using Novel Method of Jet Hydro Dissection Effects on Postoperative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Augmentation
Keywords: Breast augmentation
Breast implants
Silicone implants
Breast surgery
Lead sponsor: Aristocrat Plastic Surgery and MedAesthetics
Sponsor class: OTHER
Collaborators: name: Erbe-med
name: Tiger Biosciences, LLC.
First posted: 2014-11-26
Enrollment: 21
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: ERBEjet Breast augmentation is a novel method of dissection of the subpectoral pocket. Study is designed to differentiate parameters of pain between randomized laterality using no touch technique. THIS IS NOT A FREE STUDY. Patients are required to pay the initial cost of surgery but will receive a refund of a partial payment. Patients must undergo evaluation at consultation and surgical quote is provided.

Detailed description: Breast augmentation in the subpectoral position has classically been associated with postoperative pain and discomfort within the first two weeks after the operation. Minimizing this pain and discomfort and ability to return to normal function soon after the operation has been the goal of numerous interventions. Minimal injury no touch dissection techniques have proven results regarding morbidity. ERBEjet is a novel dissection using a jet of local anesthetic infused saline fluid with a built in coagulation function used for dissection of soft tissues. The study is designed to randomly perform ERBEjet Breast augmentation operation unilaterally on breast augmentation and mastopexy augmentation patients undergoing traditional sub pectoral dissection technique on the contralateral side. Patient's record pain scores at regular intervals in the postoperative period. Physical examination performed by blinded practitioners assess discomfort and tenderness scores within the two weeks after the operation.

Eligibility criteria: Inclusion Criteria:

* silicone breast implants candidate

Exclusion Criteria:

* history of breast cancer
* inability to conform to post operative questionnaire and recovery follow up

Primary outcomes:
measure: Decreased postoperative pain and recovery after breast augmentation
timeFrame: Two weeks
Secondary outcomes:
measure: Decreased risk of capsular contracture
timeFrame: Three months
Other outcomes:
Locations:
city: Great Neck
country: United States
facility: Aristocrat Plastic Surgery & MedAesthetics
state: New York
city: New York
country: United States
facility: Aristocrat Plastic Surgery
state: New York
Study officials:
affiliation: Aristocrat Plastic Surgery
name: Kevin Tehrani, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03851601: Immuno-regulatory Profiling of T Cells in GVHD Treated With Extracorporeal Photopheresis
Official title: Immuno-regulatory Profiling of T Cells in Patients With Graft Versus Host Disease Treated With Extracorporeal Photopheresis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GVHD
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are recipients of allogeneic stem cell grafts with the diagnosis of GVHD according to established criteria and physician decides to treat using ECP

Brief summary: Extracorporeal Photopheresis (ECP) has been used as one of the treatments for graft versus host disease (GVHD). Responses were observed in skin, liver, GI tract, mouth, eye and lung. ECP does not cause immune suppression and therefore less risk of infection or relapse of malignancy. However, the exact mechanism of action of this expensive procedure is not fully understood and no predictors of response to ECP are known so far. This reflects the need for a better understanding of GVHD and its response to ECP. Blood samples from 15 patients who receive ECP as part of the treatment of GVHD at our institution will be collected. Samples will be analyzed using flow cytometer


Eligibility criteria: Inclusion Criteria:

1. Patients who are recipients of allogeneic stem cell grafts.
2. Patients with the diagnosis of GVHD according to established criteria and physician decides to treat using ECP
3. Patient must have 100% chimerism with the donor
4. No recent donor lymphocyte infusion.
5. Patients must be able to sustain a platelet count and a hematocrit \> 20,000/mL and \> 27% respectively, with or without transfusions.
6. The absolute WBC must be \>1500/mL
7. Patient must be willing to comply with all study procedures.

Exclusion criteria:

1. Patients who are unable to tolerate the volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe asthma or chronic obstructive pulmonary disease, hepatorenal syndrome.
2. Active bleeding.
3. International normalized ration (INR) \>2.
4. Patients with known hypersensitivity or allergy to psoralen.
5. Patients with known hypersensitivity or allergy to both citrate and heparin.
6. Patients with co-existing photosensitive disease (e.g. porphyria, systemic lupus erythematosus, albinism) or coagulation disorders.
7. Active, uncontrolled infection

Primary outcomes:
measure: effect of ECP on Tregs/TH17 ratio
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
References:
Clinical trial NCT00963001: Effect of Food on the Pharmacokinetics of Oral Treprostinil
Official title: Effect of Different Meal Types on the Pharmacokinetics of a Single 1 mg Oral Dose of UT-15C (Treprostinil Diethanolamine) Sustained Release Tablets in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Keywords: Hypertension, Pulmonary
Treprostinil
Pharmacokinetics
Treprostinil Diethanolamine
Pulmonary Arterial Hypertension
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-08-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the pharmacokinetic and safety profile of a single dose of oral treprostinil following four different meals of varying caloric and fat content.


Eligibility criteria: Inclusion Criteria:

* Subject is healthy and between the ages of 18 and 55 years, inclusive, at Screening.
* Female subjects must weigh between 45 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 50 and 120 kg, inclusive, with a BMI between 19.0-32.0 kg/m2, inclusive at Screening.
* Subject has a medical history, physical examination, vital signs, ECG and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at Screening.

Exclusion Criteria:

* Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations.
* Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
* Subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.

Primary outcomes:
measure: Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of a 1 mg treprostinil diethanolamine sustained release tablet after four different meal types.
timeFrame: Immediately prior to through 36 hours post treprostinil diethanolamine dosing for each treatment period (4 treatment periods each separated by a 7-day washout period)
measure: Adverse event monitoring
timeFrame: From the first dose of treprostinil diethanolamine through study end (Study Day 23/24)
Secondary outcomes:
measure: Clinical laboratories
timeFrame: Study Days 0, 7, 14, 21 and 23
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development
state: Texas
Study officials:
affiliation: PPD Development, LP
name: Aziz Laurent, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05487001: Perineural Dexamethasone for Continuous Femoral Nerve Block
Official title: Analgesic Effect of Dexamethasone as a Perineural Adjuvant for Continuous Femoral Nerve Block After Total Knee Arthroplasty: a Prospective Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: An alternative to improve the quality of postoperative analgesia is to use various perineural adjuvants applicable to peripheral nerve block along with local anesthetics to increase the analgesic effect. Dexamethasone is a strong and long-acting corticosteroid, which reduces postoperative nausea and vomiting and increases the duration of nerve blockade. Most of the existing clinical studies compared the analgesic effect with the placebo group after adding an adjuvant in a single shot nerve block, and there were very few cases of comparing the analgesic effect with the placebo group after adding the adjuvant in peripheral nerve block through continuous catheter infusion. Therefore, we designed this study to investigate whether the use of dexamethasone as a peripheral adjuvant for continuous femoral nerve block has a better pain and recovery profile.


Eligibility criteria: Inclusion Criteria:

1. Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
2. ASA PS 1-3

Exclusion Criteria:

1. Revision total hip arthroplasty
2. Allergy to drugs used in the study
3. Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
4. Estimated glomerular filtration rate \< 30 mL/min/1.73m2
5. Opioid dependence
6. Prolongation of PT and aPTT more than twice the upper limit of normal
7. Pre-existing neurological or anatomical disorders of the lower extremities
8. Serious psychiatric disorders

Primary outcomes:
measure: Maximum Numeric rating scale pain score at movement
timeFrame: within postoperative day 2
Secondary outcomes:
measure: Numeric rating scale pain score at rest
timeFrame: up to postoperative day 2
measure: Numeric rating scale pain score at movement
timeFrame: up to postoperative day 2
measure: Postoperative opioid consumption
timeFrame: up to postoperative day 2
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References:
Clinical trial NCT03912701: Early Warning Systems, Risk of Early Clinical Deterioration
Official title: If Early Warning Systems Were Used, Could the Risk of Early Clinical Deterioration be Predicted and Re-admission to Intensive Care Could be Prevented
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Clinical Deterioration
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over the age of 18 and discharged and admitted to intensive care in the first 24 hours

Brief summary: Primary purpose of the study was to evaluate the relationship between "NEWS" and "VIEWS" scores of patients who were screened retrospectively, early clinical deterioration, return to intensive care and morbidity / mortality.


Eligibility criteria: Inclusion Criteria:

* over 18 years
* patients who were taken back to the intensive care unit in the first 24 hours

Exclusion Criteria:

* under 18 years old,
* patients undergoing postoperative intensive care,
* pregnant women

Primary outcomes:
measure: Number of patients who were taken back to intensive care unit due to early clinical deterioration
timeFrame: six month
Secondary outcomes:
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan University
Study officials:
References:
citation: Kaben A, Correa F, Reinhart K, Settmacher U, Gummert J, Kalff R, Sakr Y. Readmission to a surgical intensive care unit: incidence, outcome and risk factors. Crit Care. 2008;12(5):R123. doi: 10.1186/cc7023. Epub 2008 Oct 6.
citation: Prytherch DR, Smith GB, Schmidt PE, Featherstone PI. ViEWS--Towards a national early warning score for detecting adult inpatient deterioration. Resuscitation. 2010 Aug;81(8):932-7. doi: 10.1016/j.resuscitation.2010.04.014.
citation: McGinley A, Pearse RM. A national early warning score for acutely ill patients. BMJ. 2012 Aug 8;345:e5310. doi: 10.1136/bmj.e5310. No abstract available.
Clinical trial NCT00218101: Buprenorphine as a Treatment for Individuals Dependent on Analgesic Opioids
Official title: Dose Reduction Strategies in Oral Opioid Dependence Subsequent to Pain Management: An Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Keywords: opioid dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 2005-09-22
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Opioids used to treat chronic pain have a high abuse potential. The purpose of this study is to determine the effectiveness of buprenorphine in treating opioid dependent individuals who abuse opioids that are prescribed for chronic pain.

Detailed description: Many individuals who take opioids for chronic pain abuse the opioid medication. Buprenorphine is an opioid partial agonist that may be effective in treating individuals who abuse opiate pain medication. The purpose of this study is to compare two buprenorphine dosing regimens in order to determine which regimen is more effective in reducing opiate pain medication use and facilitating successful opioid detoxification.

This study will last 27 weeks. Participants will receive a maintenance dose of 8 mg of buprenorphine for 6 weeks, followed by a dose reduction in 2 mg increments over the course of the following 20 weeks. All participants will attend weekly clinical management sessions for the duration of the study.

Eligibility criteria: Inclusion Criteria:

* Current opioid analgesic dependence
* History of at least 2 years of oral opiate analgesic use
* Prescribed opioids for chronic pain
* Pain episode of at least 6 months duration within the 5 years prior to study entry
* Available for the duration of the study
* Good general health

Exclusion Criteria:

* Currently using any illicit substance
* Meets criteria for alcohol dependence
* History of heroin use
* History of opiate replacement therapy, including Levo-Alpha Acetyl Methadol (LAAM) or methadone
* Evidence of current maximal primary pain

Primary outcomes:
measure: Substance use
measure: medication compliance
measure: treatment retention
Secondary outcomes:
measure: Behavioral and psychological measures (measured during the dose reduction phase)
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas
name: John Grabowski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00315601: Intrapulmonary Pharmacokinetics of Antibiotics
Official title: Comparison of the Intrapulmonary and Plasma Concentrations of Telithromycin and Azithromycin in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Healthy
Keywords: Telithromycin (drug)
Azithromycin (drug)
Bronchoalveolar lavage (procedure)
Pharmacokinetics
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2006-04-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The major objectives of this research are to see how much, and for how long, telithromycin and azithromycin get into the fluids and cells of the lung.

Detailed description: The primary objective of this descriptive study is to determine and compare the plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM) concentrations following multiple oral doses of telithromycin and azithromycin in healthy, non-smoking adult subjects.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 55 years, inclusive, of age
* No history of smoking within the last 1 year
* Body weight within +/- 15% of the Metropolitan Life Insurance Company tables
* No clinically important abnormalities in the medical history or physical exam
* Female subjects of childbearing potential must have a negative pregnancy test
* Female subjects of childbearing potential must use reliable methods of birth control

Exclusion Criteria:

* Allergy to telithromycin, azithromycin, or any macrolide antibiotic
* Allergy or serious adverse reactions to benzodiazepines or lidocaine
* History of renal, gastrointestinal, or liver disease
* Significant hypertension
* Clinically significant heart or pulmonary diseases
* History of drug or alcohol dependence within 12 months of study entry
* Positive pregnancy test
* Currently breast feeding
* Use of any drug within 2 weeks of study entry
* Received an investigational drug within 30 days of study entry

Primary outcomes:
measure: Plasma and intrapulmonary drug concentrations and pharmacokinetic parameters
timeFrame: 7 days
Secondary outcomes:
measure: How long does the study antibiotics get into the fluids and cells of the lung.
timeFrame: 7 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates PA
state: Arizona
Study officials:
affiliation: University of Illinois at Chicago
name: Keith A. Rodvold, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pulmonary Associates, PA
name: Mark H. Gotfried, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago
name: Larry H. Danziger, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: