louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03290859: Race-Specific Propofol Titration to Effect for Procedural Sedation
Official title: Pragmatic Clinical Trial of Race-Specific Response to Propofol Infusion Titrated to Effect for Procedural Sedation During Endoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unconsciousness
Apnea, Postanesthetic
Sedative Overdose
Hypoxemia
Keywords: Procedural Sedation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2017-09-25
Enrollment: 2780
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing propofol sedation at Gainesville (GNV) and Jacksonville (JAX) GI Endoscopy suites

Brief summary: Prospectively evaluate newly established guidelines and make clinicians aware of inter-racial difference in propofol sensitivity.

Detailed description: The primary motivation in conducting this study is to conduct the implementation science, i.e., formalize and train, and retrain if needed, anesthesia providers in the standard practice of titrating infusion rate to effect and clinically evaluate the effect of race and ethnicity on propofol monotherapy sedation during GI endoscopy. The ultimate goal is to make it less likely that patients from races known to be sensitive to propofol experience inadvertent overdosing.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing propofol sedation at Gainesville (GNV) and Jacksonville (JAX) GI Endoscopy suites
* Age range 18 - 80 years old
* Patients whose race can be identified from the electronic patient information chart (EPIC)

Exclusion Criteria:

* Patients who identify as multiracial in Epic
* Patients who identify as Other in Epic
* Patients who refuse to indicate their race in Epic
* Patients whose race is listed as unknown in Epic

Primary outcomes:
measure: Change in the recovery times among races and ethnicities
timeFrame: Change from baseline up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Jeffrey White, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05001659: The Comparison of the Two Simulators for ACLS Training
Official title: The Comparison of the Two Simulators for ACLS Straining:Does the Computer Simulator Have the Same Effectiveness as the Mannequin Simulato
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Computer Simulator and Mannequin Simulator
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Compared two different training simulators(the computer screen-based simulator versus the full-scale mannequin-based simulator) with respect to training effectiveness in ACLS training.At the same time,evaluate the effectiveness of combination of these two simulators(screen-based simulation followed by mannequin-based simulation),so that to find out a new simulation format for ACLS training.

Detailed description: A prospective,single-blinded,randomized controlled study was used.30 first-year residents were randomized to Computer screen-based simulator group(C group),full scale Mannequin-based group(M group) and screen+Mannequin combing group(SM group).After a 30min ACLS lecture and 30min integrated CPR hands-on training,all groups received a pretest.The C group was exposed to two ACLS computer scenarions,M group was exposed to two ACLS mannequin scenario.Each scenario took 10min and followed by 20min debriefing with simulation educator.After the training session,each participant completed by modified'megacode'checklist.

Eligibility criteria: Inclusion Criteria:

- training doctors,intern Exclusion Criteria:Standardized training of doctors，Medical students

-

Primary outcomes:
measure: the effection of the two different simulators for ACLS training.
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: the Computer Simulator,the Mannequin Simulator
state: Tianjin
city: Tianjin
country: China
facility: the Computer Simulator,the Mannequin Simulator
state: Tianjin
Study officials:
References:
Clinical trial NCT00919659: Parenteral Nutrition Support for Patients With Pancreatic Cancer
Official title: Parenteral Nutrition Support for Patients With Pancreatic Cancer. A Phase II Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer Cachexia
Pancreatic Cancer
Keywords: parenteral nutrition
cancer cachexia
pancreatic cancer
Lead sponsor: CONKO-Studiengruppe
Sponsor class: OTHER
Collaborators: name: Fresenius AG
First posted: 2009-06-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether the additional nutrition support is improving the nutritional status of patients suffering cancer caxechia or not.

Detailed description: To examine the impact of additional parenteral nutrition (APN) we prospective evaluated 32 pts suffering APC and progressive cachexia. This assay is based on a bioelectrical impedance analysis (BIA) as a proven tool for nutritional investigation in patients with chronic disease. Phase angle, determined by BIA, has been found to be a prognostic indicator in several chronic and malignant conditions, such as HIV, liver cirrhosis, chronic obstructive pulmonary disease lung cancer and pancreatic cancer.

Eligibility criteria: Inclusion Criteria:

* histological proved pancreatic cancer
* progressive cancer cachexia
* refractive to enteral supplementation
* informed consent

Exclusion Criteria:

* prefinal status
* septic disease

Primary outcomes:
measure: nutritional status presented by phase angle
timeFrame: 12 weeks
Secondary outcomes:
measure: quantity of port infections, quantity of oedema, quantity of diarrhea
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin - Charité
Study officials:
affiliation: CONKO-Studiengruppe
name: helmut oettle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pelzer U, Arnold D, Govercin M, Stieler J, Doerken B, Riess H, Oettle H. Parenteral nutrition support for patients with pancreatic cancer. Results of a phase II study. BMC Cancer. 2010 Mar 9;10:86. doi: 10.1186/1471-2407-10-86.
Clinical trial NCT02597959: Reducing Musculoskeletal Stresses and Work-related Injuries Among Allied Health Professionals in Surgical Care
Official title: Exposure Assessment and Intervention for Reducing Musculoskeletal Stresses and Work-related Injuries Among Allied Health Professionals in Surgical Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Injury
Musculoskeletal Illness
Keywords: ergonomic risk factors
allied health professionals
surgical care
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical Assistants, Circulating Nurses, and Scrub Nurses (Surgical Technicians) employed at Mayo Clinic Rochester, MN, are the subjects for Aims 1 and 2. The subject population for the future Aim 3 includes surgical assistant anatomy laboratory students enrolled through the Mayo School of Health Sciences Surgical First Assistant Program, fall 2015.

Brief summary: 1. What are the risk factors that contribute to musculoskeletal injuries and fatigue on allied health professionals in surgical care (e.g. scrub nurses, surgical assistants, and circulating nurses)?
2. Can the investigators design wearable devices that the investigators can later evaluate?


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Employed at Mayo Clinic Rochester as Surgical Assistant, Circulating Nurse, and Scrub Nurse (Surgical Technicians)

Exclusion Criteria, Aims 1 and 2:

* None

Primary outcomes:
measure: Frequency of awkward postures
timeFrame: 4 months
Secondary outcomes:
measure: Open-ended questionnaire on workflow and usability process to develop automated, unobtrusive, and cost-effective wearable device
timeFrame: 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Susan Hallbeck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00439959: Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults
Official title: A Double-Blind, Parallel, Randomized, Placebo-Controlled, Single and Repeat Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK625433 in Healthy Subjects and in Subjects Who Are Chronically Infected With Hepatitis C.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hepatitis C, Chronic
Hepatitis C
Keywords: GSK625433,
Hepatitis C,
metabolic probe,
food-effect,
HCV,
FTIH
polymerase,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-02-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study represents the first administration of GSK625433 in humans. The study is designed to evaluate initial safety and tolerability in healthy adults as well as anti-viral activity in Hepatitis C(HVC) infected adults. The way the human body processes GSK625433 will also be investigated.


Eligibility criteria: Inclusion criteria:

* Healthy males \& females
* Part 1 ages 18-60
* Part 2 ages 18-50 \& 65-80
* Within normal weight range given your height
* Negative urine drug and alcohol test
* Willing to follow all study procedures

Exclusion criteria:

* Any significant abnormal lab, ECG, medical or physical exam finding during screening
* Allergy to the study drug
* Excessive alcohol intake
* Positive HIV or hepatitis B or C result
* Use of prescription or non-prescription drugs within one week of study start except for birth control
* Blood pressure meds \& Tylenol
* Pregnant or lactating women

Primary outcomes:
measure: Safety parameters: adverse events; telemetry; clinical laboratory values, vital signs, and ECGs. Plasma levels of GSK625433. Change in HCV viral load. Taken throughout the study
timeFrame: 17 Days
Secondary outcomes:
measure: Plasma levels of GSK625433. Metabolic analysis of CYP substrates to estimate enzyme activity. Resistance analysis for subjects with HCV infection. Taken throughout the study
timeFrame: 17 Days
Other outcomes:
Locations:
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02471859: A Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Participants
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral-Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Subjects.


Eligibility criteria: Inclusion Criteria:

* Is male or female, using highly effective contraception
* Has a body mass index (BMI) 18.0 to 30.0 kg/m2, inclusive
* Is in good general health
* Having signed informed consent, is willing and able to comply with requirements of the study

Exclusion Criteria:

* Does not satisfy all screening criteria per protocol
* Is employed by or related to any personnel involved in the trial
* Has any history or condition that per protocol or in the opinion of the investigator could compromise the participant's safety or analysis of results

Primary outcomes:
measure: Number of participants experiencing an adverse event
timeFrame: Up to approximately 6 months
Secondary outcomes:
measure: Maximum concentration (Cmax) for GDC-3280
timeFrame: Up to 4 days
measure: Time to Cmax (Tmax) for GDC-3280
timeFrame: Up to 4 days
measure: Total serum clearance for GDC-3280
timeFrame: Up to 4 days
measure: Volume of distribution for GDC-3280
timeFrame: Up to 4 days
measure: Elimination half-life for GDC-3280
timeFrame: Up to 4 days
measure: Serum GDC-3280 concentration-time data by dosing group
timeFrame: Up to 4 days
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05148559: Impact of Adolescent Vaccine Reminder Notices Sent Via Preferred Method of Communication on HPV Vaccination
Official title: Understanding and Addressing the Disparity in Vaccination Coverage Among U.S. Adolescents Living in Rural Versus Urban Areas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Papillomavirus Vaccines
Lead sponsor: Marshfield Clinic Research Foundation
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2021-12-08
Enrollment: 5451
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Vaccine uptake in the United States is lower in rural areas, especially for HPV vaccine. Reminder/recall has been identified as an effective strategy to increase vaccination rates. This study will assess the impact by rurality of vaccine reminder notices sent via the parent's preferred method of communication on HPV vaccination among 12 year-old patients in a regional healthcare system.


Eligibility criteria: Inclusion Criteria:

* Marshfield Clinic Health System patient aged 12 years with at least one preventive visit or two evaluation \& management visits with a Marshfield Clinic Health System provider in the last 36 months
* Due for at least one adolescent vaccine (HPV, MenACWY, Tdap)

Exclusion Criteria:

* Primary care provider is not affiliated with Marshfield Clinic Health System
* Opted out of Marshfield Clinic Health System vaccine reminder notifications
* Missing or invalid contact information
* Deceased

Primary outcomes:
measure: Number of patients that received 1 dose of HPV vaccine during follow-up based on electronic health data
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Marshfield
country: United States
facility: Marshfield Clinic Health System
state: Wisconsin
Study officials:
affiliation: Marshfield Clinic Research Institute
name: Huong McLean, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03223259: Educating the Educator to Reduce Risk of Dance Student Injury
Official title: Educating the Educator to Reduce Risk of Dance Student Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injuries
Keywords: Dance Injuries
Injury Prevention Workshops
Motor Skill Theory
Gross Motor Skills
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A group of dance educators will attend two dance injury prevention workshops hosted by the Harkness Center for Dance Injuries (HCDI), NYU Langone Medical Center, during which participants will learn strategies to help them train their students in safe ways and impart injury prevention information through their dance classes to their students. The educators will take pre- and post-workshop tests to assess knowledge and perceptions of dance medicine. Several weeks later, participants will take a follow-up survey to assess knowledge implementation and workshop effectiveness.


Eligibility criteria: Inclusion Criteria:

* Teach dance to children in at least one private dance school
* Must be able to receive email and complete a survey online
* Must believe that students lack access to dance injury prevention resources
* Must teach at least one group of students that takes class from them a minimum of twice a week and must teach those students regularly in September and October, 2017.

Exclusion Criteria:

* Under the Age of 18

Primary outcomes:
measure: Change in Score on Injury Prevention Workshop Pre-Test and Post-Test
timeFrame: 20 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Donald Rose, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01418859: Clinical Study in Post-operation Treatment of Cervical Cancer
Official title: Status and the Application of Topotecan at Post-operation Treatment of Cervical Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Keywords: cervical cancer
postoperation
chemotherapy
radiotherapy
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2011-08-17
Enrollment: 183
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who underwent the cervical cancer radical surgery in three months have higt risk factors which including deep stromal invasion,large primary tumour and/or lymphovascular spase invasion.

Brief summary: The purpose of the research is to evaluate the effect of additional chemotherapy in postoperation therapy of cervical cancer patients with risk factors (big tumor, deep invasion or tumor thrombi in the vascular system).

Detailed description: Cervical cancer has a very high morbidity. Many patients need additional therapy after surgery in order to elevate the survival rate and life quality. In this research, we are going to give additional therapy to patients who have big tumor, deep invasion or tumor thrombi in the vascular system after surgery. randomized control method will be used in this research, in order to compare the survival rate and side effects between radiation therapy only, concurrent chemoradiotherapy, and concurrent chemoradiotherapy with additional chemotherapy. 3D-CRT and Topotecan will be used in this research.

Eligibility criteria: Inclusion Criteria:

1. patients who underwent the cervical cancer radical surgery in three months have higt risk factors which including deep stromal invasion,large primary tumour and/or lymphovascular spase invasion;
2. squamous carcinoma;
3. age\<70;
4. Gynecologic Oncology Group (GOG):0-2.

Exclusion Criteria:

1. negative nodes,surgical margin,and/or parametrium;
2. No serious damage to the liver and kidney function, no hypertension,diabetes and other effects of therapy complications.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xi'an Jiaotong University College of Medicine
state: Shanxi
Study officials:
affiliation: Affiliated Hospital of Medical College of Xo'an Jiaotong University
name: Chen M W, M.D
role: STUDY_DIRECTOR
References:
citation: Sun W, Wang T, Shi F, Wang J, Wang J, Hui B, Zhang Y, Lu J, Chen H, Liu Z. Randomized phase III trial of radiotherapy or chemoradiotherapy with topotecan and cisplatin in intermediate-risk cervical cancer patients after radical hysterectomy. BMC Cancer. 2015 May 4;15:353. doi: 10.1186/s12885-015-1355-1.
Clinical trial NCT00545259: Pharmacokinetic Study of AEB071 in Patients Following Liver Transplantation
Official title: An Open-label, Two-period, Multi-center, Single Dose Study to Assess the Pharmacokinetics of AEB071 in de Novo Liver Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: de Novo Liver Transplantation
Keywords: Organ transplant, liver, pharmacokinetics, AEB071, immunosuppression
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study will evaluate the pharmacokinetic profile of AEB071 in the immediate post-transplant period in patients who have undergone their first liver transplant.


Eligibility criteria: Inclusion Criteria:

* Primary liver transplant recipients.
* Transplanted liver functioning at an acceptable level by 24 h post-transplant
* Patients started on tacrolimus therapy within 12 h post-transplant

Exclusion Criteria:

* Previous transplantation or multiple organs transplantation
* Acute rejection
* Non-heart beating donor

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: -Pharmacokinetic of AEB071 & its primary metabolite, AEE800 at predose & up to 72 hours post-operatively -Safety & tolerability (vital signs,ECGs,clinical lab evaluations,seroius/adverse events) -AEB071,AEE800 & tacrolimus in blood for both Periods
timeFrame: at predose & 16 timepoints post-dose
Secondary outcomes:
measure: -Pharmacokinetics of tacrolimus in presence of AEB071 -Biliary excretion of AEB071 & primary metabolite (AEE800) from patients with a T-tube -Relationship of free drug concentration, α-1 acid glycoprotein concentration & pharmacokinetics AEB071
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis investigative site
city: Padova
country: Italy
facility: Novartis Investigative Site
city: Zurich
country: Switzerland
facility: Novartis investigative site
Study officials:
affiliation: Investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References: