louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03660111: Spirometric Predicted Values in Bolivia
Official title: Establishment of Spirometric Predicted Values in Bolivia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spirometry
Respiratory Function Tests
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: There is no local predicted values for spirometry available in Bolivia. The aim of the present study is to establish moderne predicted values for healthy non-smokers recruited in a major city of Bolivia, Santa Cruz De La Sierra.

Detailed description: There is no local predicted values for spirometry available in Bolivia. To establish the predicted spirometric normal values in Bolivia, 500 healthy men and women, non-smokers will be recruited to perfom spirometry using following the actual ATS/ERS 2005 guidelines.

The spirometer is a Bodybox 5500 (Medisoft, Belgium). The tests will be performed by a highly-trained pneumologist, Dr A. Ajata.

Anthropometric variables recorded: age, sex, weight, standing and sitting height.

Spirometric variables recorded: FEV1, FVC, PEF, FEV6, FEF25,50,75 and MEF Statistical anaysis will be done using R and SPSS softwares. Predicted equations will be compared with existing ones, especially the new GLI-2012 predicted equations.

Eligibility criteria: Inclusion Criteria:

* healthy and non-smokers

Exclusion Criteria:

* unhealthy smokers
* subjects unable to understand/sign informed consent unable to understand/perform spirometric measurements

Primary outcomes:
measure: FEV1
timeFrame: measurements done one time at recruitment during spirometry
measure: FVC
timeFrame: measurements done one time at recruitment during spirometry
measure: FEV1/FVC ratio
timeFrame: measurements done one time at recruitment during spirometry
Secondary outcomes:
measure: Standing height
timeFrame: measurements done one time at recruitment just before spirometry
measure: seated height
timeFrame: measurements done one time at recruitment just before spirometry
Other outcomes:
Locations:
city: Santa Cruz
country: Bolivia
facility: Clínica del Pulmón
Study officials:
References:
Clinical trial NCT01278511: Prospective Pilot Study Validating the Canadian C-Spine Rule Pre-hospital
Official title: A Prospective Pilot Study Validating the Canadian C-Spine Rule in a Pre-hospital Setting
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Injury of Cervical Spine
Cervical Spine Fractures
Keywords: Canadian C-Spine Rule
Prehospital Emergency Care
Cervical Spine Injuries
Cervical Spine Fractures
Emergency Medicine Undergraduates
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to evaluate the safety, level of performance and level of comfort with the Canadian C-Spine rule in a prehospital setting by emergency medicine undergraduates.


Eligibility criteria: Inclusion Criteria:

* Alert, stable, adult patients presenting with an acute possible injury to the cervical spine
* Alert: GCS ≥ 14
* Stable:

  * systolic blood pressure ≥ 90 mmHg
  * respiratory frequency 12 - 20 / min
  * adult ≥ 18 years old
* Acute: ≤ 4
* Possible injury to the cervical spine:

  * posterior neck pain following any mechanism
  * no neck pain but visible injury above the clavicles
  * no neck pain or visible injury above the clavicles but a mechanism that indicates a cervical spine injury

Exclusion Criteria:

* Acute paralysis (quadriplegia, paraplegia)
* Penetrating trauma to the neck
* Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery)
* Pregnancy

Primary outcomes:
measure: Missed cervical spine injuries and fractures
timeFrame: At the first visit to the emergency department until 30 days after inclusion
Secondary outcomes:
measure: Performance of the Canadian c-spine rule
timeFrame: Analyzed at the end of the pilot study in april 2011
measure: Level of comfort
timeFrame: Analyzed at the end of the pilot study in april 2011
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Emergency Department of the University Hospitals, Catholic University Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Emergency Department of the University Hospitals, Catholic University Leuven
name: Koen Bronselaer, MD, PhD
role: STUDY_DIRECTOR
affiliation: Emergency Department of the University Hospitals, Catholic University Leuven
name: Marc Sabbe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emergency Department of the University Hospitals, Catholic University Leuven
name: Pieter Jan Van Asbroeck, Drs
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07002411: Hospitality Oriented Service Perception Evolution With Robots (HOSPER)
Official title: Hospitality Oriented Service Perception Evolution With Robots (HOSPER)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Quality of Hospital Entrance Reception
Social Robots
Keywords: Older people
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The HOSPER project aims to determine if using Pepper and NAO social robots at the IRCCS INRCA in Ancona's (Italy) entrance is a viable way to improve the current reception and guidance services for hospital visitors. The robots will offer proactive assistance and directions to departments.

Detailed description: The primary aim of the "HOSPER" project is to assess the feasibility of an innovative reception and proactive guidance service designed to enhance the quality of the existing service provided by the IRCCS INRCA in Ancona (Italy). This will be achieved through the deployment of two social robots, Pepper and NAO, located at the hospital entrance to provide information to users inquiring about directions to specific departments. Furthermore, the study will evaluate the level of participant satisfaction with their interactions with the robots.

Eligibility criteria: Inclusion Criteria:

* Possession of full cognitive capacity;

Exclusion Criteria:

* • Lack of written informed consent

Primary outcomes:
measure: perceived quality of the innovative reception service
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Usability
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
affiliation: IRCCS INRCA, Ancona, Italy
name: Letizia Ferrara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03950011: Database for Data Collection in the Context of an Enhanced Recovery After Surgery Program in Oncology Surgery
Official title: Database for Data Collection in the Context of an Enhanced Recovery After Surgery Program in Oncology Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oncology
Keywords: Enhanced Recovery After Surgery Program (ERP)
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient operated including hysterectomy and or curettage, posterior pelvectomy, conventional laparoscopic or assisted robot, or laparotomy at the Paoli-Calmettes Institute from 01 2016 to 12 2017, and incrementation from 2018.

Brief summary: Enhanced Recovery After Surgery Programs (ERP) includes multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS).

Detailed description: This database would also allow an objective evaluation of the quality of the surgical management and the follow-up.

One of the evaluation criteria will be measured by the quantity and quality of publications from this database, and also by the increase in the activity of the service concerned.

Eligibility criteria: Inclusion Criteria:

* Any patient operated including hysterectomy and or curettage, posterior pelvectomy, conventional laparoscopic or assisted robot, or laparotomy at the Paoli-Calmettes Institute from 01 2016 to 12 2017, and incrementation from 2018.

Exclusion Criteria:

* Non applicable.

Primary outcomes:
measure: Data collection
timeFrame: 4 years
Secondary outcomes:
measure: Evaluation of the quality of surgical management
timeFrame: 4 days
measure: Post-operative complications
timeFrame: 4 days
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches Du Rhone
Study officials:
References:
citation: Lambaudie E, de Nonneville A, Brun C, Laplane C, N'Guyen Duong L, Boher JM, Jauffret C, Blache G, Knight S, Cini E, Houvenaeghel G, Blache JL. Enhanced recovery after surgery program in Gynaecologic Oncological surgery in a minimally invasive techniques expert center. BMC Surg. 2017 Dec 28;17(1):136. doi: 10.1186/s12893-017-0332-9.
Clinical trial NCT03228511: Endoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions
Official title: Evaluation of Endoscopic-assisted Microsurgical Removal of Cerebellopontine Angle Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebellopontine Angle Tumor
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is a Prospective descriptive hospital based clinical study to determine the value of introduction of endoscope after microscopic excision of cerebello-pontine angle lesions to estimate the following :

1. Intraoperative judgement of lesions excision, residual parts, visualization and operative corridor pre and after endoscope introduction.
2. Post-operative tumor control confirmed comparison between pre and postoperative MRI.
3. Postoperative complications, advantages and disadvantages compared with these when use pure microscopic excision from the literature


Eligibility criteria: Inclusion Criteria: cerebellopontine angle lesions

* meningeoma.
* vestibular schwannoma.
* arachnoid cyst.
* petroclival meningeoma.

Exclusion Criteria:

* trigeminal neuralgia.
* facial neuralgia.

Primary outcomes:
measure: post operative residual tumor
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02331511: Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator
Official title: Effect of Aspirin and Clopidogrel in Prevention of Venous Obstruction After Implantation of Cardiac Pacemaker and Defibrillator
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complication of Cardiac Defibrillator
Disorder of Cardiac Pacemaker System
Venous Occlusion
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.

Detailed description: There are growing numbers of endocardial permanent pacemakers (PPM) and implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) device. Asymptomatic obstruction of the access vein reported to have a high incidence (30-50%) in some studies. This complication can cause some difficulties in follow up procedures such as device upgrading. The purpose of this study is to determine whether Aspirin or Clopidogrel are effective in the prevention of venous obstruction after implantation of cardiac pacemaker or defibrillator.

Eligibility criteria: Inclusion Criteria:

* patients who referred for first implantation of pacemaker, implantable cardiac defibrillator, or cardiac re synchronization therapy device

Exclusion Criteria:

* history of malignancy
* history of coagulopathy or platelet disorder
* history of venous thromboembolism
* history of gastrointestinal hemorrhage or active gastroduodenal ulcer in past 6 months
* history of chronic kidney disorder or serum creatinine more than 1.5 mg/dl
* patients who are on anticoagulant or other antithrombotic drugs or who must be on dual antiplatelet therapy.

Primary outcomes:
measure: Venus obstruction(axillary or subclavian vein) more than 50%(measure by venography)
timeFrame: 3 months
Secondary outcomes:
measure: major bleeding
timeFrame: 3 months
measure: A composite of death of any cause, myocardial infarction, or cerebrovascular accident.
timeFrame: 3 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid ModaressHospital
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Morteza Saafi, M.D.
role: STUDY_CHAIR
affiliation: Shahid Beheshti University of Medical Sciences
name: Mohammad Ali Akbarzadeh, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01860911: Plasma Triglyceride Extraction by The Muscle
Official title: Regulation of the Plasma Triglyceride Extraction in Muscle in Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Insulin Resistance
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2013-05-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Increased accumulation of fat into the muscles is associated with what is called insulin-resistant state, which is a pre-diabetic state. The purpose of this research is to find out how fat circulating in the blood following fat consumption is taken up by the muscles in healthy people as well as people that are insulin-resistant. The investigators are specifically interested in how a hormone called insulin is involved in this process. Findings from this research will contribute to our understanding of why insulin-resistant people have increased accumulation of fat in their muscles, and ultimately help to design appropriate interventions to prevent type 2 Diabetes.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI): \< 25 kg/m2 or \> 30 kg/m2;
* Insulin sensitivity index (ISI): insulin-sensitive ISI ≥ 7, insulin-resistant ISI ≤ 5.

Exclusion Criteria:

* Medication or supplements known to affect either endothelial function or lipid metabolism (i.e. arginine, protein, fish oil)
* Acute illness
* Uncontrolled metabolic disease, including liver or renal disease
* Atrial fibrillation, history of syncope, limiting or unstable angina, congestive heart failure, known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts
* Cardiac pacemaker or other medical device implanted in the body
* Pulmonary hypertension or other unstable cardiopulmonary conditions
* ECG documented abnormalities or valvular disease
* Low hemoglobin or hematocrit (i.e., lower than accepted laboratory values)
* History of hypertension or elevated blood pressure (systolic, \>140 mmHg or a diastolic, \>95 mmHg)
* History of hyperlipidemia or plasma triglyceride concentration \>200 mg/dl
* Diagnosed diabetes, or 2-h plasma glucose \>200 mg/dl during an oral glucose tolerance test
* Current participation in a weight-loss regimen, including extreme dietary practices
* Use of anabolic steroids or corticosteroids (within 3 months)

Primary outcomes:
measure: Triglyceride extraction across the forearm
timeFrame: Measured during a 7-hour infusion study
Secondary outcomes:
measure: Muscle microvascular blood volume
timeFrame: Selected 15-minute periods during the 7 hour infusion study
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Lori Roust, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arizona State University/Mayo Clinic Arizona
name: Christos S Katsanos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03371511: Sources of Bacterial Contamination in Human Milk Samples From the MiLC Trial
Official title: Sources of Bacterial Contamination in Human Milk Samples From the Milk in Life Conditions (MiLC) Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Communities
Keywords: Microbiota
Microbiome
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Idaho
First posted: 2017-12-13
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mother-infant dyads who participated in the MiLC Trial. These were healthy, lactating women 18 years or older. Women had no signs of breast infection and self-reported that they nor their infants had signs/symptoms of acute illness 7 days before participating in the study. We also restricted participation to women who pumped with electric breast pumps, who could donate 1 oz of their milk on two consecutive pumping sessions from the same breast, and women whose infants had not consumed formula within the past 2 weeks. A full description of eligibility criteria can be found on the original protocol (ClinicalTrials.gov Identifier: NCT03123874).

Brief summary: This observational study is a sub-study of the MiLC Trial (ClinicalTrials.gov Identifier: NCT03123874). Our objective is to characterize the bacterial communities of women's breasts, hands, their pump and milk collection kit, and their babies' mouths among the participants of the MiLC Trial. As part of the original protocol, we collected swabs of each of these areas from each dyad before women pumped with their own pumps. By characterizing these communities, we can identify from where the bacteria in human milk (HM) originates, and determine whether pumping with mother's own pumps enriches the bacterial communities of HM compared to pumping with a sterile pump.


Eligibility criteria: Inclusion Criteria:

* Mother-infant dyads who participated in the MiLC Trial.

Exclusion Criteria:

* Anyone who did not participate in the MiLC Trial.

Primary outcomes:
measure: Bacterial communities
timeFrame: 0 days after pumping
Secondary outcomes:
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Hay Laboratory, B75C Wing Hall, Cornell University
state: New York
Study officials:
affiliation: Cornell University
name: Sarah M Reyes, MS
role: STUDY_DIRECTOR
affiliation: Cornell University
name: Kathleen M Rasmussen, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornell University
name: Anthony G Hay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05023811: A Study of the ADME of [14C]RIST4721 in Healthy Male Subjects
Official title: A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]RIST4721 Following a Single Oral Dose to Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
ADME
Lead sponsor: Aristea Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-27
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of \[14C\]RIST4721 Following a Single Oral Dose to Healthy Male Subjects


Eligibility criteria: Inclusion Criteria:

* Healthy males
* Must provide written informed consent
* Body mass index (BMI) 18.0 to 30.0 kg/m2 as measured at screening
* Weight ≥50 kg and ≤100 kg inclusive at screening
* Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)

Exclusion Criteria:

* Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
* Evidence of current SARS-CoV-2 infection
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study

Primary outcomes:
measure: Mass balance recovery of total radioactivity in all excreta: CumAe
timeFrame: Day 1 to Day 17
measure: Mass balance recovery of total radioactivity in all excreta: Cum%Ae
timeFrame: Day 1 to Day 17
measure: Determination of routes and rates of elimination of [14C]RIST4721 by Ae
timeFrame: Day 1 to Day 17
measure: Determination of routes and rates of elimination of [14C]RIST4721 by %Ae
timeFrame: Day 1 to Day 17
measure: Determination of routes and rates of elimination of [14C]RIST4721 by CumAe
timeFrame: Day 1 to Day 17
measure: Determination of routes and rates of elimination of [14C]RIST4721 by Cum%Ae by interval
timeFrame: Day 1 to Day 17
measure: Collection of plasma, urine and fecal samples for metabolite profiling
timeFrame: Day 1 to Day 17
measure: Collection of plasma, urine and fecal samples for structural identification
timeFrame: Day 1 to Day 17
measure: Collection of plasma, urine and fecal samples for quantification analysis
timeFrame: Day 1 to Day 17
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences Ltd
Study officials:
References: