louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02472314: Exparel for Postoperative Pain Management in Shoulder Surgery
Official title: A Novel Application of Exparel for Postoperative Pain Management in Shoulder Arthroplasty and Humerus Fracture Fixation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fracture of Shoulder and Upper Arm
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 70
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 compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.

Detailed description: liposomal bupivacaine analgesia will provide improved postoperative pain control, reduction in amount of opioid supplementation, decreased complications and faster return to function compared to current standard of care pain management for patients undergoing shoulder arthroplasty and shoulder surgery for proximal humerus fractures.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing shoulder arthroplasty under general anesthesia
* Patients undergoing open reduction internal fixation (ORIF) of a proximal humerus fracture under general anesthesia
* Patients with American Society of Anesthesiologist (ASA) physical status classification of 1-3
* Patients meeting criteria for standard of care continuous peripheral nerve block (CPNB) per anesthesia guidelines.
* Patients agreeing to be available for brief follow up telephone survey post- operatively and being mentally able to respond.
* Patients available for follow up routine post-operative clinic visits, per standard of care.

Exclusion Criteria:

* Contraindications to regional anesthesia
* Significant peripheral neuropathy or neurological disorder affecting the upper extremity
* Contraindication to a component of multimodal analgesia
* Pregnancy
* Opioid tolerance
* Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.

Primary outcomes:
measure: Quality of Analgesia
timeFrame: 30 days
Secondary outcomes:
measure: Post Operative American Shoulder and Elbow Surgeons (ASES)
timeFrame: Preoperative, 6 weeks and last follow up
measure: Subjective Shoulder Value (SSV)
timeFrame: Pre-operative, 6 weeks and last Follow up
measure: Incidence of Nerve Injury
timeFrame: During hospital stay and at 2 weeks and 6 weeks post-operatively
measure: Post Operative Opioid Consumption
timeFrame: During hospital stay up to 48 hours after surgery
Other outcomes:
Locations:
city: Dearborn
country: United States
facility: Wayne State University Physician Group
state: Michigan
Study officials:
References:
Clinical trial NCT04865614: Comparison Between Inhalation and Intravenous Induction of Anaesthesia During Interventional Mitral Valve Repair
Official title: Comparison Between Inhalation and Intravenous Induction of Anaesthesia During Interventional Mitral Valve Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Hypotension Drug-Induced
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: University Hospital, Essen
First posted: 2021-04-29
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing interventional mitral valve repair

Brief summary: The induction of anaesthesia is one of the most critical situations for high-risk-patients undergoing interventions surgery. For several reasons, it is crucial to maintain adequate blood pressure and cardiac output during this phase.

This retrospective cohort study aims to find out if the choice of the induction agent has a major impact on blood pressure and the use of catecholamines during the induction and the interventional procedure in patients undergoing interventional mitral valve repair.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective interventional mitral valve repair
* Sevoflurane or etomidate have been used for induction of anesthesia

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Post-induction hypotension
timeFrame: First 20 minutes after induction of anaesthesia
Secondary outcomes:
measure: Use of catecholamines after induction during the first 20 minutes after inductionafter induction
timeFrame: First 20 minutes after induction
measure: Use of catecholamines
timeFrame: Length of procedure (Approximately 60 to 90 minutes in average)
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Anästhesiologische Klinik (Universitätsklinikum Heidelberg)
state: Baden-Würtemberg
Study officials:
affiliation: Heidelberg University
name: Adrian E Stephan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04850014: PBPK Modelling Applied to Acetaminophen Poisoned Obese Children
Official title: Physiologically-based Pharmacokinetic Modelling Applied to Acetaminophen- Poisoned Obese Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Poisoning
Obesity
Keywords: PBPK
Modelling
Acetaminophen
Paracetamol
Pediatrics
Obesity
Pharmacokinetics
Toxicokinetics
Poisoning
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 300
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Poisoned acetaminophen subjects
* At least one acetaminophen blood sample result available in data base

Brief summary: Childhood obesity is increasing globally. Changes in body composition and physiology in obesity setting modify pharmacokinetic parameters and might increase the risk in case of poisoning. Acetaminophen is a drug often implied in poisoning in children population, especially in adolescent attempting suicide. In practice, clinicians use weight to assess intoxication severity, but depending on the weight chosen (actual weight, lean body weight, ideal weight,..) the severity assessment can change as well as medical care needed. In this context we hypothesize that a PBPK modelling would be helpful to predict toxic dosing in obese population and especially in obese adolescent or children. The primary objective of this study is to collect data related to acetaminophen-poisoned patient with at least one acetaminophen concentration sampling and whose clinical outcome is known in order to refine and validate such a PBPK model.


Eligibility criteria: Inclusion Criteria:

* All subjects \>/= 10 year old
* Availability of at least one positive acetaminophen concentration with its associated sampling time
* Known clinical outcome

Exclusion Criteria:

* \< 10 year old
* lack of data-

Primary outcomes:
measure: Acetaminophen concentration
timeFrame: 31 october 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT02848014: The Effects of Interventions Aiming at Optimizing Expectations and Inducing Positive Emotions After an Acute Stressor
Official title: The Effects of Interventions Aiming at Optimizing Expectations and Inducing Positive Emotions After an Acute Stressor on Subjective and Objective Stress Paramaters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to determine whether a short psychological intervention aiming at optimizing expectations is able to foster positive emotions and whether an intervention inducing positive emotions is able improve participants' expectations. Furthermore, the investigators will examine whether both interventions are effective in buffering the stress response after an acute stressor in a healthy sample compared to a control condition.


Eligibility criteria: Inclusion Criteria:

* fluent in German language

Exclusion Criteria:

* chronic disease
* mental disease
* the evening before the day of the experiment until end of the experiment (the next day): caffeine, alcohol, intensive physical exercise, chewing gum
* acute hay fever
* current intake of psychotropic medication

Primary outcomes:
measure: Change in personal control expectation (Item of the Brief IPQ)
timeFrame: Pre-intervention (baseline; T0) vs. Post-intervention (25 minutes after baseline assessment; T1)
Secondary outcomes:
measure: Change in emotions (PANAS)
timeFrame: Pre-intervention (baseline; T0) vs. Post-intervention (25 minutes after baseline assessment; T1)
measure: Subjective stress ratings
timeFrame: directly after completing the stress induction (approximately 50 minutes after baseline assessment; T2)
measure: Change in Cortisol levels (saliva sample)
timeFrame: Pre-intervention (baseline; T0) vs.Post-intervention (25 minutes after baseline assessment; T1), directly (T2), 15 min (T3) and 30 min (T4) after stress induction
measure: Change in Alpha-Amylase levels (saliva sample)
timeFrame: Pre-intervention (baseline; T0) vs. Post-intervention (25 minutes after baseline assessment; T1), directly (T2), 15 min (T3) and 30 min (T4) after stress induction
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Department of Psychology, Philipps University Marburg
state: Hessen
Study officials:
affiliation: Philipps University Marburg
name: Winfried Rief, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00883714: Exercise During the Allogeneic Stem Cell Transplantation
Official title: Exercise During the Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fatigue
Allogeneic Stem Cell Transplantation
Keywords: Exercise
sport
Allogeneic blood stem cell transplantation
Blood stem cell transplantation
Fatigue
Cancer
Physical performance
Mood
Complications
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2009-04-20
Enrollment: 60
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: SUPPORTIVE_CARE

Brief summary: The study will evaluate the effects of a structured endurance exercise program on the physical performance, the mood and the complications of patients with hematological malignancies undergoing a high-dose chemotherapy followed by an allogeneic peripheral blood stem cell transplantation.


Eligibility criteria: Inclusion Criteria:

* Neoplastic malignancy
* Allogeneic peripheral stem cell transplantation
* Proficiency in German

Exclusion Criteria:

* Cardiorespiratory, metabolical, osteoarticular or immunological disorders which can be aggravated by exercise
* Pathological stress-ECG at admission

Primary outcomes:
measure: VO2max
timeFrame: At recruitment and after 4 weeks
Secondary outcomes:
measure: Complications
timeFrame: 4 weeks
measure: Mood
timeFrame: At recruitment and after 4 weeks
measure: Requirement for blood and platelets transfusions
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30
Study officials:
affiliation: Charite University, Berlin, Germany
name: Fernando Dimeo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01353014: Genetic Information and Dietary Intake Behaviour
Official title: Genetic Information and Dietary Intake Behaviour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Nutrigenomics
Diet
Nutrition
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Advance Foods and Materials Network
First posted: 2011-05-12
Enrollment: 138
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study's primary objective is to determine if providing individuals with personal genetic information impacts dietary intake behaviour. Specifically, the investigators will be examining whether providing dietary advice based on genes that affect the metabolism of or sensitivity to caffeine, vitamin C, sugar and sodium will impact the intake of these dietary components. The study hypothesis is that providing dietary advice based on genetics will impact dietary behaviour to a greater extent than general dietary recommendations.


Eligibility criteria: Inclusion Criteria:

* 20-35 year old participants from the Toronto Nutrigenomics and Health Study

Exclusion Criteria:

* pregnancy or nursing
* vitamin C supplement users
* caffeine intake \< 100 mg/day
* total sugars intake \< 10% energy
* sodium intake \< 1500 mg/day

Primary outcomes:
measure: Change from Baseline in Dietary Intake at 3 months
timeFrame: 3 months
measure: Change from Baseline in Dietary Intake at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Ahmed El-Sohemy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nielsen DE, El-Sohemy A. Disclosure of genetic information and change in dietary intake: a randomized controlled trial. PLoS One. 2014 Nov 14;9(11):e112665. doi: 10.1371/journal.pone.0112665. eCollection 2014.
Clinical trial NCT02068014: Standarization for Stappler Application During Sleeve Gastrectomy
Official title: Implication and Factors Influencing the Decision to Select Srapplers During Laparoscopic Sleeve Gastrectomy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: stapplers- obesity- stomach
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients underwnt laparoscopic sleev gastrectomy between 18 y.o. and 70 y.o.

Brief summary: Sleev gastrectomy is a procedure performed for permanent treatment of obesity. For the procedure, cutting of the stomach is performed with differents long of stapplers.

The aim of the study is to determine wich long of stappler is applicable in any stage of the procedure ans the variation expected.

Detailed description: After permormed laparoscopic sleeve gastrectomy the stonach retrieved for pathology study will be messured in three ponts: antrum, body and fundus.

In each point medition of the two walls and any wall (anterior and posterior) will be messurd.

Those data will be stariscally analized to perform a applicable guidelines for stapller selection.

Eligibility criteria: Inclusion Criteria:

* every laparoscopic sleeve gastrectomy
* between 18 y.o. and 70 y.o.
* no previous gastric operation

Exclusion Criteria:

* under 18 y.o. or over 70 y.o. previous gastric surgery

Primary outcomes:
measure: differences in wall mesurments
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assuta MC
Study officials:
References:
Clinical trial NCT02889614: Prevalence Assessment and Characterization of Psychological Disorders Associated With Hypobetalipoproteinemia
Official title: Prevalence Assessment and Characterization of Psychological Disorders Associated With Hypobetalipoproteinemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypobetalipoproteinemia
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted in mental Disorders Unit in Nantes University Hospital

Brief summary: Familial hypobetalipoproteinemia (FHBL, OMIM # 1707730) is a genetic disorder heterozygotic of LDL-C metabolism. Clinical manifestation range from asymptomatic patients to metabolic (fatty liver, diabetes) or psychiatric disorders still unrecognized. HYPOPSY research, aims to evaluate prevalence of hypobetalipoproteinemia, and to characterize specific related psychiatric disorders.

Detailed description: Familial hypobetalipoproteinemia (FHBL, OMIM # 1707730) is a genetic disorder heterozygotic of LDL-C metabolism (Low Density Lipoprotein - Cholesterol) whose incidence is measured from 1: 500 to 1: 1000. These heterozygous individuals may be asymptomatic or present some clinical (fatty liver, diabetes) or psychiatric manifestations still unrecognized. Moreover, these individuals have mostly a longevity syndrome and cardiovascular protection. The FHBL is often due to mutations of the APOB (APOlipoprotein B), major component of LDL, VLDL (Very Low Density Lipoprotein) and chylomicrons, and in some cases, loss-of-function mutations of the serine protease PCSK9, endogenous inhibitor of the LDL receptor.

HYPOPSY research, aims to evaluate, in a population with psychiatric disorders, the prevalence of hypobetalipoproteinemia, and to characterize specific related psychiatric disorders.

Eligibility criteria: Inclusion Criteria:

* Patients admitted in mental Disorders Unit in Nantes University Hospital

Exclusion Criteria:

* Minor patient

Primary outcomes:
measure: Frequency of hypobetalipoproteinemia (LDL-C ≤ 50 mg/dL without hypolipidemic treatment) among psychiatric patients managed in Nantes University Hospital
timeFrame: Inclusion.
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References:
Clinical trial NCT06982014: Impact of Moulage-Based Simulation on Nursing Students' Recognition of Physical Violence
Official title: The Effect of Simulation Training Using the Moulage Technique on Nursing Students' Knowledge and Attitudes Toward Identifying Physical Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Education
Keywords: Moulage-based simulation
Violence against women
Nursing education
Physical violence recognition
Educational methods
Lead sponsor: Kocaeli Sağlık ve Teknoloji Üniversitesi
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of moulage-based simulation training in improving nursing students' ability to recognize physical violence in women. The main questions it aims to answer are:

Does moulage-based simulation improve nursing students' ability to recognize signs of physical violence in women compared to traditional training methods? How does the simulation affect nursing students' attitudes and knowledge about gender-based violence? Researchers will compare an experimental group, which will participate in moulage-based simulation training, to a control group that will receive a standard educational video on the topic of gender-based violence. This comparison will assess whether the simulation method provides better outcomes in terms of recognizing violence and improving students' attitudes.

Participants will:

Engage in a clinical simulation involving standardized patients showing signs of physical violence.

Complete pre- and post-training assessments, including attitude surveys and knowledge tests.

Reflect on their learning experience through post-intervention evaluations.


Eligibility criteria: Inclusion Criteria:

* Students studying in the nursing department at Kocaeli Health and Technology University in the 2024-2025 academic year
* Registered in the Mental Health and Psychiatric Nursing course
* Accepted to participate in the study

Exclusion Criteria:

* Students not registered in the Mental Health and Psychiatric Nursing course.
* Refused to participate in the study
* Students who withdrew from the study after giving their consent.

Primary outcomes:
measure: recognition of Physical Violence
timeFrame: one day
Secondary outcomes:
measure: Communication Skills
timeFrame: one day
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli Health and Technology University
Study officials:
References:
Clinical trial NCT02948114: The Effect of Feeding Infant Formula Containing Prebiotics and/or Probiotics
Official title: The Effect of Feeding Infant Formula Containing Prebiotics and/or Probiotics
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metabolomics
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Beijing Kangchen Technologies
First posted: 2016-10-28
Enrollment: 2
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study is intended to evaluate the microorganisms found in infant stools when consuming study formulas containing prebiotics and/or probiotics compared to infants consuming mother's own breast milk.


Eligibility criteria: Inclusion Criteria:

* Singleton, 10-14 days of age at registration/randomization
* Term infant with birth weight of 2500 grams or more from a vaginal birth
* Formula feeding infants must be on formula for at least 3 days
* Human milk fed infants must have received mother's own breast milk from 1 day of age to study registration and mother has intention to exclusively provide mother's own breast milk for the duration of the study
* Signed informed consent

Exclusion Criteria:

* History of underlying metabolic or chronic disease or immune compromised
* Feeding difficulties or formula intolerance

Primary outcomes:
measure: Change in fecal microbiota
timeFrame: 3.5 months
Secondary outcomes:
measure: Body Weight measured at each study visit
timeFrame: Up to 3.5 months
measure: Body Length measured at each study visit
timeFrame: Up to 3.5 months
measure: Head circumference measured at each study visit
timeFrame: Up to 3.5 months
measure: Recall of infant formula usage at each study visit
timeFrame: Up to 3.5 months
measure: Recall of gastrointestinal tolerance questionnaire at each study visit
timeFrame: Up to 3.5 months
measure: Medically-confirmed adverse events collected throughout the study period
timeFrame: Up to 3.5 months
Other outcomes:
Locations:
city: Haikou
country: China
facility: Hainan Province Women & Children Hospital
state: Hainan
Study officials:
affiliation: Mead Johnson Nutrition
name: Steven Wu
role: STUDY_DIRECTOR
References: