louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04178694: The Influence of Non-invasive Ventilation on Metabolism in Healthy Volunteers
Official title: The Influence of Non-invasive Ventilation on Metabolism in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Expenditure
Non-invasive Ventilation
Metabolism
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Before inclusion in the trial. Careful medical history and medication use will be asked. Once included, 5 healthy subjects non-invasive ventilation(V60, Philips, Eindhoven, The Netherlands) will be administered at a level of positive end expiratory pressure (PEEP) of 4 cmH2O and without additional inspiratory support. Inspiratory support will then increase by 2 cmH2O every 2 minutes until 8 cmH2O is achieved for 2 minutes. The energy expenditure is measured using indirect calorimetry (Q-NRG®, Cosmed, Italy). To measure respiratory effort, the reversed RPE-scale was created for the purpose of the study. It uses the validated "rate of perceived exertion" scale (RPE-scale) which was altered by adding a reversed part. This could result in a score of -10 (no respiratory effort) until +10 ( maximal respiratory effort) where 0 represents the basal respiratory condition. Monitoring of heart rate, blood pressure and cardiac output will be done ( Nexfin®, BMEYE, Amsterdam, The Netherlands).

After termination of the study clinical observation by principal investigator or co-investigator will be done for 15 minutes or until all side effects have worn off. If no side effects are observed, subjects will be released.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* pregnancy
* prisoners
* participation in interventional study in last 2 weeks before enrolment
* Current ongoing disease:
* Cardiac
* respiratory
* ear
* nose
* gastro-intestinal
* neurological
* psychiatric

Primary outcomes:
measure: Energy expenditure
timeFrame: during non-invasive ventilation
Secondary outcomes:
measure: reversed combined rate of perceived exertion scale
timeFrame: during non-invasive ventilation
measure: respiratory rate
timeFrame: during non-invasive ventilation
measure: systolic and diastolic bloodpressure
timeFrame: during non-invasive ventilation
measure: cardiac output
timeFrame: during non-invasive ventilation
measure: CO2 production of the body ( VCO2)
timeFrame: during non-invasive ventilation
measure: O2 consumption of the body (VO2)
timeFrame: during non-invasive ventilation
measure: Respiratory quotient
timeFrame: during non-invasive ventilation
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair ziekenhuis Brussel
state: Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Joop Jonckheer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04055194: Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa
Official title: Efficacy of Antenatal Tranexamic Acid in Pregnant Women With Symptomatic Placenta Previa in Decreasing Antepartum Hemorrhage - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Placenta Previa
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pregnant women with symptomatic placenta previa with previous bleeding attacks will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo till delivery. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).
Primary purpose: PREVENTION

Brief summary: 200 pregnant women with symptomatic placenta previa with previous bleeding attacks attending Ain Shams University maternity hospital will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).


Eligibility criteria: Inclusion Criteria:

* Gestational age 28 weeks of gestation.
* Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using transvaginal ultrasound scan.
* Haemodynamically stable pregnant women.
* Maternal age:20-40years old.
* Pregnant women with placenta previa, and had previous bleeding attacks or admitted with antepartum haemorrhage.

Exclusion Criteria:

* Multiple pregnancy.
* Women with bleeding tendency due to any medical disorder (ITP, thrombocytopenia, coagulopathies),or on anticoagulants .
* Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery.
* Women have hypersensitivity or any contraindication to use of tranexamic acid.
* Pregnant women with placenta previa with doppler showing morbidly adherent placenta.

Primary outcomes:
measure: Amount of bleeding during antepartum bleeding attacks
timeFrame: 9 weeks GA
Secondary outcomes:
measure: Number of women requiring antepartum blood transfusion
timeFrame: 9 weeks GA
measure: Number of PRBCs units required during antepartum blood transfusion
timeFrame: 9 weeks GA
measure: Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery
timeFrame: 9 weeks GA
measure: Gestational age at delivery
timeFrame: 9 weeks GA
measure: Neonatal intensive care unit (NICU) admission
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain SHams Maternity Hospital
state: Abbaseya
Study officials:
affiliation: A Ramadan
name: Amal Ramadan, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05594394: Improving Charge Nurse Conflict Resolution Communication Using Artificial Intelligence
Official title: Improving Charge Nurse Conflict Resolution Communication Using Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conflict Resolution
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: • RN Clinical Team Leader or Charge Nurse employed at MMMC

Brief summary: Nurses are being challenged to provide increasingly complex care with more inexperienced nurses due to higher rates of retirement and registered nurse (RN) turnover in general.

High-performing charge nurses with excellent interpersonal, conflict management, communication, and leadership competencies are vital to achieving optimal outcomes. Implementing a charge nurse leadership development program focused on improving communication competencies in conflict management situations can support a healthy work environment.

Detailed description: Freedman (2019) asserts that "interpersonal conflict in nursing workplaces is a pervasive and complex phenomenon, with implications for patient safety and quality of care" (p.594). First-time leaders seldom receive adequate training for effective transition to leadership roles, with 60% reporting having no training (Gentry, Logan, \& Tonidandel, 2014). Furthermore, many novice leaders struggle with transitioning from peer to leader, specifically related to interpersonal and communication skills (Basogul, 2020; Radovich, et al., 2011).

Eligibility criteria: Inclusion Criteria:

* RN Clinical Team Leader or Charge Nurse employed at MMMC

Exclusion Criteria:

* Non-employees of MMMC
* MMMC staff not in the role of Clinical Team Leader or Charge Nurse

Primary outcomes:
measure: Charge nurses that have completed the program
timeFrame: September 2022 to November 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Mansfield
country: United States
facility: Methodist Mansfield Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Laura Sweatt, MSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06432894: Performance Evaluation of ANI in Patients Under General Anesthesia With Remimazolam
Official title: Performance Evaluation of Analgesia Nociception Index (ANI) in Patients Under General Anaesthesia With Remimazolam: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain Measurement
Keywords: Remimazolam
Remifentanil
Analgesia Nociception Index (ANI)
Lead sponsor: Catholic Kwandong University
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who visit the hospital and undergo surgery

Brief summary: The purpose of this study is to determine whether Analgesia Nociception Index (ANI) can effectively reduce the dose of opioid in patients who underwent general anesthesia using remimazolam.


Eligibility criteria: Inclusion Criteria:

Patients

* aged 20-79 years under general anaesthesia with remimazolam
* scheduled to undergo robotic surgery
* in American Society of Anesthesiologists physical class 1, 2 or 3
* voluntarily agree in writing to participate in this clinical study

Exclusion Criteria:

* Conditions affecting the autonomic nervous system
* other conditions or disease that may cause acute or chronic pain
* the NRS before induction of anesthesia is 1 or over
* When taking medications that may affect the autonomic nervous system
* In other cases where the investigator deems the subject unsuitable for this trial

Primary outcomes:
measure: ANI values
timeFrame: During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)
Secondary outcomes:
measure: Heart Rate (HR) change
timeFrame: Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation
measure: Patient state index (PSI) change
timeFrame: Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation
measure: Blood Pressure change
timeFrame: Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation
measure: Remimazolam infusion rate
timeFrame: During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)
measure: Effect site concentration of remifentanil
timeFrame: During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)
Other outcomes:
measure: Hemodynamic change
timeFrame: within 5 minutes of pain stimulus
Locations:
city: Incheon
country: Korea, Republic of
facility: Catholic-Kwandong University, School of Medicine
Study officials:
affiliation: Ilsan Cha hospital
name: Young Joo
role: STUDY_CHAIR
References:
Clinical trial NCT01309594: HIV Liver Regeneration Project for HIV Patients With Cirrhosis by Autologous Bone Marrow Transplantation
Official title: A Safety and Efficacy Study of Autologous Bone Marrow Cell Infusion Therapy in HIV Infected Patients With Advanced Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infection
AIDS
Cirrhosis
Lead sponsor: National Center for Global Health and Medicine, Japan
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2011-03-07
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An international investigation to evaluate if, and if so how long, autologous bone marrow hematopoietic stem cell transplantation can safely restore liver functions for HIV infected patients who have decompensated liver cirrhosis.

Detailed description: An international investigation to evaluate if, and if so how long, autologous bone marrow (ABM) hematopoietic stem cell transplantation (HSCT) can safely restore liver functions for HIV infected patients who have decompensated liver cirrhosis.

Eligibility criteria: Inclusion Criteria: Outpatients or inpatients that are treated for HIV infection at AIDS Clinical Center of National Center for Global Health and Medicine who meet all criteria following:

* have cirrhosis with 7 or higher Child-Pugh Score in Child-Pugh Score B
* able to consent and willing to participate in the study
* under good control for HIV infection

Exclusion Criteria: Cases applicable to ANY condition of the following:

* Hepatocellular carcinoma (HCC), except for cases having been completely treated without history of recurrence
* Malignant tumors other than HCC
* Alcoholic liver disease (ALD)
* Hemoglobin under 8g/dL or Platelets under 20/ml at the registration
* Esophageal or gastric varices with a risk of bursting, except for cases with only cured history of such conditions
* Cases that cannot obtain the informed consent to autologous blood transfusion
* Pregnancy
* Renal dysfunction with 2mg/dL or higher serum creatinine
* Performance Status 3 or 4 (assessment excludes hemophilic arthritis related daily life limitations)
* Cases not fit for general anesthesia
* Other conditions considered not suitable for the study by doctors

Primary outcomes:
measure: Post-transplantation prognosis for cirrhosis
timeFrame: 24 weeks
Secondary outcomes:
measure: Duration of the treatment efficacy
timeFrame: After 24 weeks up to 48 weeks
Other outcomes:
Locations:
city: Shinjuku
country: Japan
facility: National Center for Global Health and Medicine
state: Tokyo
Study officials:
affiliation: National Center for Global Health and Medicine
name: Shinichi Oka, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02682394: Evaluation of Pancreatic Steatosis in Patients With Cancer of Pancreas
Official title: Prognostic Importance of Quantitative Magnetic Resonance Imaging for Evaluation of Pancreatic Steatosis in Patients With Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer of Pancreas
Keywords: Cancer of pancreas
steatosis
MRI
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 patients diagnosed with any pancreatic cancer, in any stage, before treatment.

Brief summary: Prognostic Importance of Quantitative Magnetic Resonance Imaging for Evaluation of Pancreatic Steatosis in Patients with Pancreatic Cancer

Detailed description: 1. Finding patients with pancreatic cancer (in all stages), before any treatment.
2. Non invasively quantify fatty infiltration of pancreas using, MRI DIXON Scan in pancreatic cancer patient relatively to liver.
3. Measuring cell-free blood DNA in those patients for evaluating the aggressiveness of the disease.
4. Quantify the prognostic significance of pancreatic steatosis in comparison with clinical and pathological prognostic indexes used today.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with any pancreatic cancer, in any stage, before treatment.
* \>18 y.o

Exclusion Criteria:

* claustrophobia
* GFR\<30
* patients with non mri compatible devices (e.g. orthopaedic external fixation system)
* After chemotherapy treatment or surgical procedure

Primary outcomes:
measure: Percentage of fat in pancreas measured in the head, body and tail excluding the lesion area.
timeFrame: at 24 hours before chemotherapy starting
measure: Blood levels of free DNA
timeFrame: The blood sample taken 15 minutes prior to MRI study, at time of IV access.
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka university medical center
Study officials:
affiliation: Soroka University Medical Center
name: Alla Khashper, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06882694: Validity and Reliability of the Kinesthetic Motor Imagery of Pelvic Floor Muscle Contraction Questionnaire in Turkish
Official title: The Turkish Validity and Reliability of the Kinesthetic Motor Imagery of Pelvic Floor Muscle Contraction Questionnaire
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pelvic Floor
Motor İmagery Ability
Keywords: pelvic floor
motor imagery ability
reliability
validity
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Female participants between the ages of 18-30 who have no diagnosed pelvic floor dysfunction will be included in the study.

Brief summary: The aim of this study is to adapt the questionnaire named "Kinesthetic Motor Imagery of Pelvic Floor Muscle Contraction Questionnaire (KMI-PFQ)" into Turkish in healthy women and to introduce it to the literature as a valid and reliable questionnaire.


Eligibility criteria: Inclusion Criteria:

* Being between 18-30 years old
* Understanding and speaking Turkish
* Being willing to participate in the study
* Not having any neurological or orthopedic problems
* Not having any pelvic floor pathology diagnosed by a specialist physician

Exclusion Criteria:

* Having any previous or current pelvic floor pathology
* Not understanding or speaking Turkish

Primary outcomes:
measure: Kinesthetic Motor Imagery of Pelvic Floor Muscle Contraction Questionnaire
timeFrame: 20 minutes
Secondary outcomes:
measure: Movement Imagination Questionnaire *MIQ-3
timeFrame: 20 minutes
measure: Vividness of Visual Imagery Questionnaire (VVIQ-12)
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04568694: Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation
Official title: Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation: A Proof-of-Concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-arm study to demonstrate the proof-of-concept of semi-elective lung transplantation. We plan to evaluate 15 patients that receive lung(s) delayed for transplantation under our study criteria.


Eligibility criteria: Inclusion Criteria:

* Recipient is ≥ 18 years old
* Recipient, or their Legally Authorized Representative is able and willing to sign informed consent
* Recipient meets standard listing criteria for lung transplantation

Exclusion Criteria:

* Donor lungs meet criteria for transplantation with ex vivo lung perfusion (EVLP)
* Recipient is \< 18 years old
* Recipient, or their Legally Authorized Representative is unable to sign informed consent for re-transplantation
* Recipient has any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study

Primary outcomes:
measure: Incidence of ISHLT primary graft dysfunction grade 3 at 72 hours post-transplant
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nader Moazami, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03993080: Virtual Reality Relaxation to Decrease Dental Anxiety
Official title: Virtual Reality Relaxation to Decrease Dental Anxiety in Primary Dental Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Keywords: dental anxiety
virtual reality
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: University of St Andrews
name: University of Dundee
name: City of Helsinki
First posted: 2019-06-20
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled single-center trial with two parallel arms
Primary purpose: TREATMENT

Brief summary: The aim is to apply short-term virtual reality relaxation to examine if it is effective in reducing pre-operative dental anxiety in primary health care using an RCT.

Detailed description: Randomized controlled single-center trial with two parallel arms: Virtual Reality Relaxation (VRR) and Treatment As Usual (TAU) in a public oral health care unit. VRR group receiving a 1-3.5 minute 360° video immersing them in peaceful virtual landscape with audio features and sound supporting the relaxing experience. TAU groups remaining seated for 3 minutes in similar setting.

Eligibility criteria: Inclusion Criteria:

* attending for dental treatment
* consenting
* able to complete Finnish questionnaire without assistance
* age 18 years or older

Exclusion Criteria:

* those not meeting inclusion criteria

Primary outcomes:
measure: Dental anxiety
timeFrame: immediately after intervention
Secondary outcomes:
measure: Anticipatory dental anxiety and treatment related dental anxiety
timeFrame: immediately after intervention
Other outcomes:
Locations:
city: Turku
country: Finland
facility: University of Turku
Study officials:
affiliation: Department of Community Dentistry, University of Turku, Finland
name: Satu Lahti
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lahti S, Suominen A, Freeman R, Lahteenoja T, Humphris G. Virtual Reality Relaxation to Decrease Dental Anxiety: Immediate Effect Randomized Clinical Trial. JDR Clin Trans Res. 2020 Oct;5(4):312-318. doi: 10.1177/2380084420901679. Epub 2020 Jan 21.