louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02666677: INVITE Study: Invasive Instrumentation in Trauma Patients in the Shock Room
Official title: Invasive Instrumentation in Trauma Patients in the Shock Room: A Online-survey for Anaesthesia Departments in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Trauma
Keywords: polytrauma, emergency medicine
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Leipzig
name: Wuerzburg University Hospital
First posted: 2016-01-28
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Traumatized patiennts in the emergency department

Brief summary: This study is an online survey asking for invasive instrumention in trauma patients of an emergency department

Detailed description: The INVITE study is an online survey for medical doctors asking for invasive instrumention (e.g., arterial line, entral venous line, etc.) in trauma patients of an emergency department

Eligibility criteria: Inclusion Criteria:

* Patients with multiple trauma
* treated in the emrgency department

Exclusion Criteria:

* none

Primary outcomes:
measure: "Insertion of central venous catheter " survey
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
state: NRW
Study officials:
affiliation: UK Köln
name: Jochen Hinkelbein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01949077: Evaluation of Serum Chemokines for Patients Undergoing Treatment With Boceprevir.
Official title: Evaluation of Serum Chemokines for Patients Undergoing Treatment With Boceprevir.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hepatitis C
Keywords: Hepatitis
Hepatitis C
Observational study
Biomarkers of treatment response
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-09-24
Enrollment: 0
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: Male and female adult patients: Aged 18 and older with chronic HCV treated with triple therapy (including Boceprevir).

Brief summary: The purpose of the study is to determine differences in levels of serum chemokines from patients undergoing treatment with Boceprevir. The aim is to determine if non-responders have significantly different levels of chemokines than responders.

Detailed description: Patients undergoing standard of care at the UNC Liver Center are consented for collection of an additional serum sample under the UNC Liver Center serum and tissue bank study. These samples will be used to analyze differences in serum chemokines across responders and non-responders.

Eligibility criteria: Inclusion Criteria:

* All adult patients (age 18 or older) treated with an antiviral Hepatitis C treatment regimen that includes Boceprevir.

Exclusion Criteria:

* Inability to provide informed consent for a serum sample enrolled in the University of North Carolina Liver Center serum bank.
* No pre and post serum sample available within 6 months of the treatment period.

Primary outcomes:
measure: Level (ng/mL) of serum chemokines.
timeFrame: Baseline: <=6 months prior to start of treatment and Post-treatment: <=6-months after the last dose
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Liver Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michael W Fried, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05212077: Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Randomized Clinical Trial
Official title: Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: The Trial Will Compare Two Care Delivery Models That Are Currently Being Used in Routine Practice Settings for Acute Hospitalization
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare two care delivery models that are currently being implemented in routine practice settings. The findings from this study will inform future clinical decision making, such as which patients might be more suited for which care delivery model.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 18 years of age and older.
* Present to one of the participating hospitals.
* Have a chief complaint of one of the target diagnoses.
* Are within a certain geographical area (based on zip codes).
* Have a health insurance plan that covers ACH services.
* Have the capacity to consent or could assent with the consent of a health care proxy who is physically present.

Exclusion Criteria:

* The patient is not suitable for ACH or inpatient hospital care based on:

  * being a nursing home patient;
  * on or requiring dialysis;
  * positive for COVID-19;
  * having discharge order;
  * requiring intensive care unit (ICU) level of care;
  * history of drug abuse.
* Patients will also need to meet the clinical stability criteria.
* Do not have the capacity to consent or assent with the assistance of a health care proxy.

Primary outcomes:
measure: The primary outcome is a composite outcome of all-cause mortality
timeFrame: 30 days post-discharge
measure: 30-day readmission.
timeFrame: 30 days post-discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Eau Claire
country: United States
facility: Mayo Clinic Health System
state: Wisconsin
Study officials:
References:
citation: Yao X, Paulson M, Maniaci MJ, Dunn AN, Nelson CR, Behnken EM, Hart MS, Sangaralingham LR, Inselman SA, Lampman MA, Dunlay SM, Dowdy SC, Habermann EB. Effect of hospital-at-home vs. traditional brick-and-mortar hospital care in acutely ill adults: study protocol for a pragmatic randomized controlled trial. Trials. 2022 Jun 16;23(1):503. doi: 10.1186/s13063-022-06430-6.
Clinical trial NCT04172077: Self Efficacy Levels, Attachment Style and Resiliency of Youth With Type 1 Diabetes
Official title: Association Of Self Efficacy Levels, Resiliency Levels and Attachment Styles of Adolescents With Type 1 Diabetes and Their Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type1diabetes
Keywords: Self Efficacy
Resiliency
Attachment style and youth with type 1 diabetes
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 170
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: T1DM patients aged 12 - 18 yrs from Sick Kids Diabetes Clinic and their primary caregiver.

Brief summary: This project will assess self-efficacy levels(SE) ,resiliency and attachment style of adolescent with type 1 diabetes and their caregivers.SE and attachment style of patients and parents will be compared with each other as well as correlated with diabetes management as assessed by A1C and self inventory scale.


Eligibility criteria: Inclusion Criteria:

* T1DM patients age 12 - 18 yrs from Sick Kids Diabetes Clinic and a primary caregiver
* T1DM \> 1yr and able to communicate in English

Exclusion Criteria:

* Families who cannot communicate in English (read, write, speak)
* Diagnosed less than 1 year diabetes
* Transient form of Diabetes (such as medication induced diabetes)
* Exclude type 2 Diabetes and CFRD (cystic fibrosis related diabetes)

Primary outcomes:
measure: Examine the effects of patients' attachment styles (secure, mixed and fearful) on their type one diabetes management represented by A1C level
timeFrame: 25 minutes
Secondary outcomes:
measure: a) Effect of attachment style on self efficacy level in patients.
timeFrame: 25 minutes
measure: a) Effect of attachment style on self efficacy level in parents.
timeFrame: 25 minutes
measure: b)Compare diabetes management self-efficacy and attachment style in patients.
timeFrame: 25 minutes
measure: b)Compare diabetes management self-efficacy and attachment style in parents
timeFrame: 25 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Sick Kids Hospital
name: Vanita Pais, BSc,CDE
role: PRINCIPAL_INVESTIGATOR
affiliation: Sick Kids Hospital
name: Christabelle Almeida, MSc,CDE
role: STUDY_DIRECTOR
References:
Clinical trial NCT05956977: Evaluation of 3D Ultrasound in Brain Tumor Surgery
Official title: Evaluation of 3D Ultrasound in Brain Tumor Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Residual Tumor
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: Brainlab AG
First posted: 2023-07-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: retrospective matched pair control
Primary purpose: TREATMENT

Brief summary: Evaluation of impact of use of 3D ultrasound in brain tumor surgery on extend of resection. Benefit for surgery, neurological outcome, accuracy and image quality are secondary outcome parameters. Control group is a retrospective matched pair cohort.


Eligibility criteria: Inclusion Criteria:

* age above 18 suspected intra-axial lesion (metastasis or Glioma) potential gross total resection of lesion

Exclusion Criteria:

* no ability for informed consent

Primary outcomes:
measure: Extent of resection
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: image quality
timeFrame: during surgery
measure: neurological outcome
timeFrame: both after surgery and at 3 months
measure: Accuracy of device
timeFrame: during surgery
Other outcomes:
measure: brainshift during surgery
timeFrame: during surgery
Locations:
city: Tübingen
country: Germany
facility: University of Tübingen
state: Baden Würtemberg
city: Ulm
country: Germany
facility: University of Ulm
Study officials:
References:
citation: Aleo D, Elshaer Z, Pfnur A, Schuler PJ, Fontanella MM, Wirtz CR, Pala A, Coburger J. Evaluation of a Navigated 3D Ultrasound Integration for Brain Tumor Surgery: First Results of an Ongoing Prospective Study. Curr Oncol. 2022 Sep 15;29(9):6594-6609. doi: 10.3390/curroncol29090518.
Clinical trial NCT04302077: Patient Satisfaction With Virtual Post Operative Visits: Hip Arthroscopy
Official title: Patient Satisfaction With Virtual Post Operative Visits: Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoroacetabular Impingement
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 75
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: HEALTH_SERVICES_RESEARCH

Brief summary: This is a prospective, randomized study designed to evaluate the effects of different initial postoperative follow-up modalities. Given the nature of the study, it is not possible for either the surgeons or the subjects to be blinded. Patients will be assigned to either group based on the last digit of their medical record number (MRN). Patients with an even-ending medical record number will be randomized to virtual visit/telemedicine, while patients with an odd-ending medical record number will be randomized to the office visit.

Detailed description: This study aims to evaluate the differences between two forms of postoperative follow-up with respect to patient satisfaction. The primary outcome will be patient satisfaction with their surgeon and with their overall experience. Following their second postoperative visit, the subjects will complete one electronic survey. The survey is designed to assess subject's overall satisfaction and satisfaction with their surgery. This survey is standardized and will be used by both groups.

Eligibility criteria: Inclusion Criteria:

* Participants undergoing arthroscopic hip surgery

Exclusion Criteria:

* Age \< 18 years old or Age \> 70 years old

Primary outcomes:
measure: Change in patient satisfaction
timeFrame: 3 month follow up visit
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone
name: Guillem Gonzalez-Lomas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04918277: Gastric Volume in the Fasted Pediatric Cerebral Palsy Patients
Official title: Ultrasound Assessment of Gastric Volume and Aspiration Risk Evaluation in the Fasted Pediatric Cerebral Palsy Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aspiration, Respiratory
Cerebral Palsy
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 38
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cerebral palsy under the age of 18 undergoing surgery under general anesthesia

Brief summary: In children with cerebral palsy, the gastric volume is measured through ultrasound after fasting before surgery to evaluate whether the risk of aspiration is higher than that of the general population.


Eligibility criteria: Inclusion Criteria:

* Patients with cerebral palsy under the age of 18 undergoing surgery under general anesthesia

Exclusion Criteria:

* Levin tube or gastrostomy tube in situ
* Decline to participate

Primary outcomes:
measure: gastric volume
timeFrame: preoperative 1 days to postoperative 1 days
Secondary outcomes:
measure: Grade of gastric fullness
timeFrame: preoperative 1 days to postoperative 1 days
Other outcomes:
Locations:
Study officials:
References:
citation: Spencer AO, Walker AM, Yeung AK, Lardner DR, Yee K, Mulvey JM, Perlas A. Ultrasound assessment of gastric volume in the fasted pediatric patient undergoing upper gastrointestinal endoscopy: development of a predictive model using endoscopically suctioned volumes. Paediatr Anaesth. 2015 Mar;25(3):301-8. doi: 10.1111/pan.12581. Epub 2014 Dec 11.
Clinical trial NCT04673877: Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration
Official title: Tissue Concentrations of Vancomycin Achieved With Bier Block Administration Versus Intravenous Prophylaxis in Upper Extremity Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection
Hand Injury Wrist
Hand Injuries
Hand Injuries and Disorders
Hand Arthritis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 20
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: The purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (upper extremity) is more effective at preventing infection than the current standard dose which is given intravenously (IV).


Eligibility criteria: Inclusion Criteria:

* Patients undergoing upper extremity reconstruction by a single surgeon.
* Surgical cases will include:

  * Trapeziectomy/suspensionplasty.
  * PIPJ/MPJ arthroplasty.
  * Proximal row carpectomy.
  * Distal ulnar resection.
  * Distal radius fracture fixation.

Exclusion Criteria:

* Inability to adequately cannulate a superficial vein in the upper extremity within 5 minutes of tourniquet inflation.
* Evidence of subcutaneous extravasation in Bier block group.
* History of renal dysfunction.
* Vancomycin allergy.
* ASA\>/= 3.
* History of lung cancer.
* Known HIV infection.
* History of organ transplantation.

Primary outcomes:
measure: Tissue concentrations of vancomycin
timeFrame: Approximately 45-60 minutes after skin incision
Secondary outcomes:
measure: Adverse Events
timeFrame: 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Kevin Renfree, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01477177: Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus
Official title: Pilot Study of Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus With Low Grade and High Grade Dysplasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Barrett's Esophagus
Keywords: Barrett's esophagus dysplasia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Chek-Med Systems, Inc.
First posted: 2011-11-22
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 98
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to provide an initial assessment of the feasibility, safety and efficacy of Polar Wand carbon dioxide cryotherapy for treatment of Barrett's low grade and high grade dysplasia by use in a small number of patients so as to support, or otherwise, the development of a full-scale trial.

Detailed description: Prospective pilot study to be performed in 14 Barrett's Esophagus patients with low grade and high grade dysplasia, referred for standard of care treatment. Patients will receive treatments with carbon dioxide Polar Wand cryotherapy at 0, 2 and 4 months, followed by surveillance endoscopy with four quadrant biopsies throughout the entire Barrett's esophagus (BE)segment at 6 months, followed by endoscopy with additional treatments (if needed) at 8 and 10 months, followed by a final surveillance endoscopy at 12 months, with four quadrant biopsies throughout the entire initial BE segment length.

Eligibility criteria: Inclusion Criteria:

* Patients referred for treatment with Barrett's esophagus with dysplasia as the original indication for ablative treatment.
* Previous fundoplication surgery is permitted
* Age 18 years to 98 years
* Ability to provide written, informed consent

Exclusion Criteria:

* Inability to obtain biopsies due to anticoagulation, varices, etc.
* Previous ablation therapy, wide area mucosal resection or external beam radiation to the thorax.
* Intolerance to twice daily proton pump inhibitor medication or inability to undergo sedation or endoscopic procedures.
* Worse than Grade B erosive esophagitis
* Less than 3 weeks from previous endoscopy with biopsy or 6 weeks from previous endoscopic therapy (resection).

Primary outcomes:
measure: Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification
timeFrame: 12 months
Secondary outcomes:
measure: Reduction in Barrett's Segment Length, Using the Prague Classification
timeFrame: 6 and 12 months
measure: Assessment of Complications
timeFrame: 12 months
measure: Assessment of Post-ablation Symptoms
timeFrame: 12 months
measure: Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification
timeFrame: 6 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
References:
Clinical trial NCT02458677: Single Ascending Dose Study of PRX003 in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX003 Administered by Intravenous Infusion in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Prothena Biosciences Limited
Sponsor class: INDUSTRY
First posted: 2015-06-01
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 40 healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Body mass index (BMI) between 18-32 kg/m2 with a minimum weight of 45 kg
* Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception
* Male subjects and their partners of childbearing potential must use contraception

Exclusion Criteria:

* Positive test for drug of abuse
* Past or current history of alcohol abuse
* Positive for TB, hepatitis B, hepatitis C or HIV infection

Primary outcomes:
measure: Safety and tolerability as determined by number of subjects with adverse events
timeFrame: Up to 3 months
measure: Determination of pharmacokinetics parameters-(Cmax)
timeFrame: Up to 3 months
measure: Determination of pharmacokinetics parameters-(AUClast)
timeFrame: Up to 3 months
measure: Determination of pharmacokinetics parameters-(AUCinf)
timeFrame: Up to 3 months
measure: Determination of pharmacokinetics parameters-elimination rate constant
timeFrame: Up to 3 months
measure: Determination of pharmacokinetics parameters-(t½)
timeFrame: Up to 3 months
measure: Determination of pharmacokinetics parameters-(CL)
timeFrame: Up to 3 months
measure: Determination of pharmacokinetics parameters-(Vd)
timeFrame: Up to 3 months
Secondary outcomes:
measure: Immunogenicity as determined by measurement of anti-PRX003 antibodies
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Worldwide Clinical Trials Early Phase Services
state: Texas
Study officials:
References: