louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01174836: Patient and Physician Attitudes About Informed Consent for Emergency Department (ED) Computerized Axial Tomography (CT) Scans
Official title: Patient and Physician Attitudes About Informed Consent for Emergency Department (ED) Computerized Axial Tomography (CT) Scans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attitudes About CT Utilization
Keywords: CT utilization
physician attitudes
Lead sponsor: Lehigh Valley Hospital
Sponsor class: OTHER
First posted: 2010-08-04
Enrollment: 77
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Hypothesis: The majority of Emergency physicians and patients do not feel that specific informed consent should be obtained for ED CT scans.

Secondary Hypothesis: Emergency attending physicians and residents will have similar attitudes about CT scan consent issues. Physician attitudes toward obtaining consent for CT scans will change after an educational program about the associated risks.

Detailed description: ED residents and ED attendings who attend grand rounds will be given a survey and asked to anonymously complete the first portion before grand rounds (Figure 1, example A). The first portion will assess basic demographics, CT ordering patterns and experiences, and attitudes about informed consent. They will be provided with an educational program at grand rounds that reviews current literature relevant to CT utilization and consent issues. After the lecture they will be asked to complete the second section of the survey (Figure 1, Example B). Both portions of the survey will be simultaneously returned in a sealed envelope and placed in a collection box at grand rounds.

ED attendings who do not attend grand rounds will only be asked to complete the first portion of the survey (Figure 1, example A). Resident or attending consent to participate will not be coerced, and participation will be implied by completion of the survey.

Eligibility criteria: Inclusion Criteria:

* Current ED resident and attending physicians
* An ED patient (or their surrogate) that is able to understand and respond in writing to the questions given.

Exclusion Criteria:

* Anyone who declines to participate.
* An ED patient who is not able to understand questions or respond in writing to the questions given (and does not have a surrogate that understands questions and respond in writing to the questions given).

Primary outcomes:
measure: Survey response to physician attitudes about ordering CT
timeFrame: 30 minutes (after lecture) resurvey
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05577936: Xperience™ vs Normal Saline Irrigation Solution for Decreasing Bioburden After Primary Total Hip and Knee Arthroplasty
Official title: A Randomized Controlled Trial of the Next Science® XPERIENCE™ Advanced Surgical Irrigation Versus Standard of Care Irrigation Efficacy in Decreasing Bioburden in Primary Total Hip and Knee Arthroplasty Wounds
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Total Knee Replacement Surgery
Total Hip Replacement Surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of Xperience, a no rinse antimicrobial solution, on joint infection rates in patients undergoing total hip (THA) and total knee (TKA) arthoplasty surgery.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo primary total hip (via direct anterior approach, press-fit components) or total knee arthroplasty (via manual approach, cemented components).
* Willing to comply with all study-related procedures and be available for the duration of the study.
* Provide signed and dated informed consent.

Exclusion Criteria:

* Unable to provide signed and dated informed consent.
* Unwilling or unable to comply with all study-related procedures.
* Known history of sensitivity or allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings).
* Has underlying condition or state that, in the 'investigator's opinion, would make them too critically ill to complete the day 90 postoperative follow ups.
* Pregnant, planning to become pregnant, or nursing female subjects.
* Subject with any mental impairment or condition that would make them unable to properly consent without use of LAR or additional subject protections.
* Subject is a prisoner and/or part of a vulnerable subject population, which necessitates additional human research subject protections beyond the scope of this protocol.
* Subject with an active infection or systemic antibiotic therapy within 2 weeks prior to surgery with the exception of preoperative antimicrobial prophylaxis.

Primary outcomes:
measure: Change in culture positive rates
timeFrame: Baseline (pre-irrigation) and post-irrigation approximately 3 minutes
Secondary outcomes:
measure: Deep Periprosthetic Joint Infection
timeFrame: 90 days
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Cameron Ledford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05255536: Effect of Different Local Anesthetic Volumes of Serratus Anterior Plan Block After Video-Assisted Thoracoscopic Surgery
Official title: The Effect of Different Local Anesthetic Volumes of Serratus Anterior Plan Block Performed With Ultrasound on Acute Pain After Video-Assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Serratus Anterior Plane Block
Pain, Postoperative
Thoracic Surgery, Video-Assisted
Local Anesthetic
Lead sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block, serratus anterior plane block (SAPB), and erector spinae plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB and SAPB are some of them. In addition, SAPB application is increasing in patients who underwent thoracotomy and VATS. There is no consensus on the dose of analgesia in these studies. There are studies on volumes between 10 ml and 40 ml in the literature. In this study, it was aimed to compare the volumes of 20 ml and 30 ml containing local anesthetic at the same concentration (0.25% bupivacaine) of SAPB block to be performed with USG in patients who underwent VATS.


Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old
* ASA physical status I-II-III
* BMI 18 to 30 kg/m2
* Elective video assisted thoracoscopic surgery

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* Chronic opioid or analgesic use

Primary outcomes:
measure: Pain Scores
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Morphine Consumption
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Kecioren
country: Turkey
facility: Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
state: Ankara
Study officials:
affiliation: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
name: Musa Zengin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03681236: The Effect of Alveolar Recruitment Maneuver in Laparoscopic Surgery
Official title: The Effect of Alveolar Recruitment Maneuver on Postoperative Pulmonary Complications in Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pulmonary Complication
Keywords: Alveolar recruitment, laparoscopic surgery
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Investigating the effect of alveolar recruitment on the incidence of postoperative pulmonary complication in patients who undergo laparoscopic surgery

Detailed description: Comparing ventilation with PEEP (positive end expiratory pressure) to ventilation with PEEP and alveolar recruitment, we expect that alveolar recruitment will reduce the incidence of pulmonary complication in patients undergo laparoscopic surgery. Ventilation with only PEEP is generally not enough to reduce postoperative pulmonary complication effectively.

Eligibility criteria: Inclusion Criteria:

* Adult patients, ASA I-II, scheduled to elective laparoscopic surgery

Exclusion Criteria:

* Chronic lung disease
* Cardiovascular disease
* ASA class ≥ III
* Receiving ventilation therapy or received within 6 months
* Refusal of participation in study or failure in informed consent

Primary outcomes:
measure: Postoperative pulmonary complication
timeFrame: Immediately after entering PACU
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital, department of Anesthesia and pain
state: Gyenggo-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Ah Young Oh, M.D., Ph. D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00780936: Effects of a Peripheral Nerve Block on Biomarkers of Pain and Inflammation
Official title: Effect of Peripheral Nerve Block on Inflammatory and Nociceptive Biomarkers in a UV-B Burn Model in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-10-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effect of a local anesthetic nerve block on markers of inflammation and pain after a sunburn. This is important because it may provide information regarding the way that nerve blocks help with the treatment of pain and in particular provide preemptive analgesia.


Eligibility criteria: Inclusion Criteria:1. Between 18 and 50 years of age 2. Fluent in English language 3. Provide written informed consent 4. Skin pigmentation type II or III\&#xA; Exclusion Criteria:1. Current use of prescription drugs interfering with study objective 2. Use of over-the-counter analgesic/anti-inflammatory drugs within 48h of study participation 3. Current acute or chronic pain conditions 4. Significant medical conditions including psychiatric, neurological, and dermatological diseases 5. Pregnancy 6. Allergies to study drug(s) 7. Concomitant participation in other study protocol

Primary outcomes:
measure: Measurement of the effect of a preemptive peripheral nerve block on the hyperalgesic response to an artificially induced sunburn.
Secondary outcomes:
measure: Measurement of the effect of a preemptive peripheral nerve block on the release of pro-inflammatory cytokines.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Martin S Angst
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00390936: A Study of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
Official title: Phase I Multiple Ascending Dose Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Japanese Patients With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-10-23
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the dose limiting toxicity (DLT) of BMS-582664 and the maximum tolerated dose(MTD) in subjects with advanced or metastatic solid tumors.


Eligibility criteria: Inclusion Criteria:

* Patients must have measurable disease
* Documented failure to standard therapies exist, or which are determined to be inappropriate by the investigator
* ECOG PS: 0-1

Exclusion Criteria:

* Subjects with centrally located squamous cell carcinoma of the lung

Primary outcomes:
measure: Dose Limiting Toxicity
timeFrame: at the end of the first cycle of the study
measure: Maximum Tolerated Dose
timeFrame: at the end of the first cycle of the study
Secondary outcomes:
measure: To assess any preliminary evidence of anti-tumor activity observed with BMS-582664
timeFrame: at the end of the study
Other outcomes:
Locations:
city: Sunto-Gun
country: Japan
facility: Local Institution
state: Shizuoka
Study officials:
affiliation: Bristol Myers
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03916536: Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate.
Official title: Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate for Treatment of Large Sized Benign Prostatic Enlargement. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Hypertrophy
Holmium Laser
Thulium Laser
Bipolar Diathermy
Prostate Enucleation
Keywords: Holmium Laser
Thulium Laser
Bipolar diathermy
prostate enucleation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 155
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Because of the diversity of the studies and deficiency of those comparing various techniques of EEP for treatment of LUTs secondary to BPO in patients with large sized prostate, we aim in this study at testing the non-inferiority of PKEP and ThuLEP to HoLEP in relieving LUTs secondary to BPO in patients prostate size \>80ml. Our hypothesis is to present an evidence that enucleation is a technique rather than a power dependent procedure through a RCT.


Eligibility criteria: Inclusion Criteria:

* Patients' age \>50 years
* Lower urinary tract symptoms LUTS secondary benigh prostatic obstruction BPO who failed medical treatment
* International prostate symptom scores (IPSS) \>15 and bother score quality of life (QOL) \> 3 (according to IPSS question 8)
* Maximum urinary flow rate (Q max) \<15 ml/sec with at least 150 ml voided volume or cases with acute urine retention secondary to BPO who failed trial of voiding on medical treatment.
* Transrectal ultrasound TRUS estimated total prostate size 80-250cc

Exclusion Criteria:

* Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
* Active urinary tract infection (positive urine culture) till treatment
* Presence of bladder cancer (within the last 2 years)
* Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.

Primary outcomes:
measure: urinary functional outcomes using uroflowmetry
timeFrame: 2 years
Secondary outcomes:
measure: patient symptoms
timeFrame: 2 years
measure: perioperative complications
timeFrame: 2 years
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
state: Dakahlia
Study officials:
References:
Clinical trial NCT01480336: The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot
Official title: The Pharmacokinetics and Electrocardiographic Implications of Adjunctive Amiodarone and Ranolazine Therapy in Patients on Implantable Cardioverter Defibrillators: The Adjunctive Ventricular Arrhythmia Suppression Trial (AVAST) Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia
Keywords: Arrhythmia
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2011-11-28
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to learn if combination therapy with amiodarone and ranolazine (an approved drug for chest pain) can help prevent arrhythmias.


Eligibility criteria: Inclusion Criteria:

* Patients with an ICD who were on a stable dose of amiodarone for the past 60 days

Exclusion Criteria:

* Patients with a life expectancy of less than 6 months
* Patients with moderate or severe hepatic impairment (Child-Pugh Classes B or C) or requiring hemodialysis.
* Pregnancy or lactation.
* Treatment with potent CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, indinavir, and saquinavir
* Treatment with CYP3A inducers, including rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort.

Primary outcomes:
measure: Pharmacokinetic Parameter Estimates
timeFrame: 12 hours
Secondary outcomes:
measure: Electrocardiogram (ECG)
timeFrame: 12 hours
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: William Baker, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02903836: Phase II Study of Oral Nafithromycin in CABP
Official title: A Phase II, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Community-Acquired Bacterial Pneumonia (CABP)
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
Collaborators: name: ACM
First posted: 2016-09-16
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults


Eligibility criteria: Inclusion Criteria:

Meet the clinical criteria for CABP based on following:

1. Clinical symptoms (new or worsening)
2. Vital sign abnormalities
3. Laboratory abnormalities
4. Radiographic evidence of CABP
5. PORT score

Exclusion Criteria:

1. Subjects with any of the following confirmed or suspected types of pneumonia:

   1. Aspiration pneumonia
   2. Hospital-acquired bacterial pneumonia (HABP)
   3. Healthcare-associated bacterial pneumonia (HCAP)
   4. Ventilator-associated bacterial pneumonia (VABP)
   5. Pneumonia that may be caused by pathogen(s) resistant to either study drug
2. Receipt of 1 or more dose(s) of a potentially effective systemic antibacterial treatment for treatment of the current CABP
3. Suspected or confirmed non-infectious causes of pulmonary infiltrates
4. Subjects requiring concomitant adjunctive or additional potentially-effective systemic antibacterial treatment for management of CABP

Primary outcomes:
measure: Clinical Response in the ITT Population
timeFrame: Day 4 from start of drug administration
Secondary outcomes:
measure: Clinical Response in the Micro-ITT Population
timeFrame: Day 4 from start of drug administration
Other outcomes:
Locations:
city: Miami Lakes
country: United States
facility: Empire Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: A & L Clinical research
state: Florida
city: Miami
country: United States
facility: A Plus Research Inc.
state: Florida
city: Miami
country: United States
facility: RM Medical Research, Inc.
state: Florida
city: Bedford
country: United States
facility: HCI Metromedic Walkin Medical Center
state: Massachusetts
city: Bedford
country: United States
facility: Health Concepts
state: South Dakota
Study officials:
affiliation: Wockhardt
name: Ashima Bhatia, MD PDCR
role: STUDY_DIRECTOR
References:
Clinical trial NCT03319836: Meeting Protein Targets in Critically Ill Patients
Official title: Meeting Protein Targets in Critically Ill Patients: A Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Dietary Modification
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2017-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult medical/surgical ICU patients that received enteral nutrition with or without a very high protein enteral nutrition formula.

Brief summary: This is a retrospective study of protein and energy intake in enterally fed critically ill adult patients before and after the introduction of a very high protein enteral nutrition formula in a single center medical/surgical ICU.


Eligibility criteria: Inclusion Criteria:

* Adult patients ≥ 18 years of age, mechanically ventilated
* Received enteral nutrition for a minimum of five days during the first week of ICU admission

Exclusion Criteria:

* Received parenteral nutrition during first week of ICU admission
* Acute renal failure not dialyzed
* Hepatic encephalopathy grade 3 or 4
* Intentional underfeeding/trophic feeding - including refeeding syndrome

Primary outcomes:
measure: Daily total protein intake
timeFrame: Daily up to 7 days of ICU stay
Secondary outcomes:
measure: Daily caloric intake - Total Calories
timeFrame: Daily up to 7 days of ICU stay
measure: Daily caloric intake - kcal/kg
timeFrame: Daily up to 7 days of ICU stay
measure: Daily caloric intake from enteral nutrition
timeFrame: Daily up to 7 days of ICU stay
measure: Percentage of prescribed calorie needs met
timeFrame: Daily up to 7 days of ICU stay
measure: Feeding interruptions
timeFrame: Daily up to 7 days of ICU stay
measure: Use of inotropes/vasopressors (highest daily dose prescribed)
timeFrame: Daily up to 7 days of ICU stay
measure: Feeding tolerance
timeFrame: Daily up to 7 days of ICU stay
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Centre
name: Michele ApSimon
role: PRINCIPAL_INVESTIGATOR
References: