louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02850237: Pre-Hospital Cerebral Oxygenation and End-Tidal CO2 During Cardiopulmonary Resuscitation (CPR)
Official title: Pre-Hospital Cerebral Oxygenation and End-Tidal CO2 During Cardiopulmonary Resuscitation (CPR)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: out-of Hospital Cardiac Arrest
Keywords: cerebral saturation
capnography
pre-hospital
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
First posted: 2016-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pre-hospital cardiac arrest

Brief summary: Cerebral saturation will be measured pre-hospital during an out-of hospital cardiac arrest with O3TM regional oximetry for Root® (Masimo®). The O3TM regional oximetry for Root® (Masimo®) is a device that can measure not only cerebral saturation but also end-tidal CO2 (capnography). Currently, end-tidal CO2 is already measured during Advanced Life Support following most recent European Resuscitation Guidelines but with another monitor. Until now it is the only parameter which may predict return of spontaneous circulation. Because of this, researchers want to measure both with the same device, which gives the investigators the opportunity and advantage to compare end-tidal CO2 and cerebral saturation very precisely. In this manner researchers want to investigate the predictive value of cerebral saturation and compare it end-tidal CO2.


Eligibility criteria: Inclusion Criteria:

* all consecutive OHCA patients

Exclusion Criteria:

* DNR code
* no possibility to attach cerebral oxygenation sensor

Primary outcomes:
measure: Clinical parameter: return of spontaneous circulation (ROSC) by pulse check
timeFrame: when ROSC occurs, within 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
References:
Clinical trial NCT04421937: The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Stroke Patients With Dysphagia
Official title: The Effects of Neuromuscular Electrical Stimulation on Swallowing Functions in Stroke Patients With Dysphagia: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Swallowing Disorder
Dysphagia
Stroke, Complication
Cerebrovascular Accident
Keywords: stroke
swallowing disorder
dysphagia
stroke rehabilitation
neuromuscular electrical stimulation
traditional dysphagia therapy
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 34
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: In our study, our aim is to evaluate the effect of neuromuscular electrical stimulation added to traditional dysphagia therapy in stroke patients with dysphagia, on functional oral intake status, dysphagia-related symptoms, quality of life, and complications related to dysphagia.


Eligibility criteria: Inclusion Criteria:

* After the first week after a stroke, detecting dysphagia by using bedside water assessment test
* Lesion location is shown by MRI or CT
* Unsupported sitting balance
* The score of Mini-mental state examination test (MMSE) 20 and above
* Over 18 years old

Exclusion Criteria:

* Global aphasia or cognitive disorders that may affect the understanding of the instructions
* Patients with major medical problems that may affect participation
* Tracheostomy presence
* Previous neck surgery
* To have received radiotherapy in the head or neck area
* Presence of a cardiac pacemaker or a history of epilepsy

Primary outcomes:
measure: Change in Functional Oral Intake Scale (FOIS)
timeFrame: before intervention, immediately after intervention, 3 months after the intervention
Secondary outcomes:
measure: Change in Eating Assessment Tool-10 (EAT-10) Score
timeFrame: before intervention, immediately after intervention, 3 months after the intervention
measure: Change in Swallowing-related Quality of Life (SWAL-QOL) Score
timeFrame: before intervention, immediately after intervention, 3 months after the intervention
measure: Change in Visual Analog Scale (VAS)
timeFrame: before intervention, immediately after intervention, 3 months after the intervention
measure: Change in Laryngostroboscopy Examination
timeFrame: before intervention, immediately after intervention
measure: Change in Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
timeFrame: before intervention, immediately after intervention
measure: Change in Voice-Related Quality of Life (V-RQOL) Score
timeFrame: before intervention, immediately after intervention, 3 months after the intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
state: Fatih
Study officials:
affiliation: Istanbul University
name: Elif Tarihçi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06867237: The Effect of Continuous Management of Suction Cuff Pressure and Subglottic Irrigation Suction on Preventing VALRI Study
Official title: The Effect of Continuous Management of Suction Cuff Pressure and Subglottic Irrigation Suction on the Outcomes of Mechanically Ventilated Patients With High Risk of Aspiration: a Single-center, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventilation Acquired Pneumonia
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Assessing the effectiveness of continuous cuff pressure management combined with subglottic suction irrigation in reducing ventilator-associated lower respiratory tract infections (VALRTI) in mechanically ventilated patients at high risk of aspiration.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years;
2. Undergoing endotracheal intubation or tracheostomy;
3. Expected duration of mechanical ventilation exceeding 72 hours;
4. Presence of one or more high-risk factors for reflux/aspiration: recurrent laryngeal nerve injury, cerebral infarction/cerebral hemorrhage (new or pre-existing swallowing dysfunction), cranial surgery/traumatic brain injury (TBI), neuromuscular junction disorders (e.g., myasthenia gravis, muscular dystrophy, Parkinson's disease, or other conditions that weaken swallowing muscle strength and coordination), continuous use of muscle relaxants for ≥ 48 hours during mechanical ventilation, ICU-acquired myopathy, ICU-acquired weakness, gastroparesis (gastric residual volume \> 500 mL/6 hours), or impaired consciousness;
5. Voluntary participation in the study by the subject or their legal representative, with signed informed consent.

Exclusion Criteria:

1. Expected duration of mechanical ventilation less than 48 hours;
2. Pregnant or breastfeeding women;
3. Patients with tracheoesophageal or bronchopleural fistula;
4. Difficult intubation (more than three attempts) or patients with reflux/aspiration during intubation (with lung injury and secondary pulmonary infection);
5. Patients with irreversible disease, end-stage conditions, or those expected to die in the near future;
6. Patients already diagnosed with ventilator-associated pneumonia (VAP), i.e., excluding hospital-acquired pneumonia;
7. Patients participating in other clinical trials that are expected to influence the results of this study;
8. Patients deemed unsuitable for inclusion in the study by the investigator.

Primary outcomes:
measure: The number of days free from VALRTI within 28 days.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02093637: Rapid Extremity Pain Relief by Battlefield Acupuncture After Orthopedic Surgery
Official title: Rapid Extremity Pain Relief by Battlefield Acupuncture After Orthopedic Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2014-03-21
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the addition of Battlefield Auricular Acupuncture (BFA) to standard therapy causes reduction in pain, medication use, time to ambulation without assistance, hours missed from work and increases quality of life after lower extremity surgery at two Air Force Medical Centers.

Detailed description: We will recruit 429subjects into this research study, for an expected 309 completing the study. We estimate 120 subjects will either withdraw consent or become ineligible for the study. Subjects will be ≥18 years or older and scheduled for lower extremity surgery. To randomize subjects, we will employ a random number generator, which will minimize difference between study groups. Additionally, we will collect data about patients' length of hospital stay, which will allow for statistical control of the variable, complexity of surgical procedure. The Research Assistants/Coordinators will be responsible for obtaining Informed Consent and HIPAA Authorization from subjects, collecting data, and de-identifying data prior to review and analysis by the Investigators. The Investigators will be responsible for ongoing protocol monitoring, insertion of needles, verifying inclusion/exclusion criteria, and analyzing data.

Eligibility criteria: THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion Criteria:

Male and female subjects (DoD beneficiaries), 18 years or older who are scheduled for lower extremity surgery below the hip.

Exclusion Criteria:

Pregnant or breastfeeding Absence of their ear Active cellulitis of their ear Ear anatomy precluding identification of acupuncture landmarks Non-English speaking Use of Hearing Aids that preclude the insertion of ASP needles Inability to comply with study protocol

Primary outcomes:
measure: Pain score
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Travis Air Force Base
country: United States
facility: David Grant Medical Center
state: California
city: Nellis Air Force Base
country: United States
facility: Mike O'Callaghan Federal Medical Center
state: Nevada
Study officials:
affiliation: MOFMC
name: Paul Crawford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04563637: A Comparison of Computer Vision Based Approach vs. Dual Energy X-ray Absorptiometry Scan to Measure Body Fat Percentage
Official title: A Comparison of Computer Vision Based Approach vs. Dual Energy X-ray Absorptiometry Scan to Measure Body Fat
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Health Behavior
Lead sponsor: Centennial Medical Group
Sponsor class: INDUSTRY
First posted: 2020-09-24
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females between ages 18 and 100

Brief summary: This study is being done to test whether a HealthReel computer vision-based software application can estimate body fat percentage with equivalent accuracy to a whole body dual energy x-ray absorptiometry scan.

Detailed description: This study is being done to test whether a computer vision-based software application can estimate body fat percentage with equivalent accuracy to a whole body dual energy x-ray absorptiometry scan. The dual energy x-ray absorptiometry scan involves lying on a machine for about 6-10 minutes. It is an open design. The study will also examine whether waist circumference measurement improves the accuracy of the body fat percentage estimate by the computer vision-based application.A total of approximately 492 subjects are planned to take part in this study at one study center.

Eligibility criteria: Inclusion Criteria:

* Have the ability to provide informed consent before any trial-related activities
* Male or female, age \> = 18 at time of signing informed consent
* Have access to and ability to use a smart phone to take a 15 second video from their home

Exclusion Criteria:

* Pregnancy at the time of screening
* Known osteoporosis with a T-score of \<-2.5 at hip or spine or pathological fracture of spine
* Cirrhosis of the liver, or presence of ascites

Primary outcomes:
measure: variance in body fat percentage between computervision application and dexa scan
timeFrame: 8 months
Secondary outcomes:
measure: abdominal circumference
timeFrame: 8 months
Other outcomes:
Locations:
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
Study officials:
affiliation: Centennial Medical Group
name: Steven Geller
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04208737: Effects of Recruitment Maneuver on Functional Residual Capacity
Official title: Comparing Effects of Recruitment Maneuver on Functional Residual Capacity in Patients Undergo Laparoscopic Surgery : A Randomized Prospective Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Surgery
Atelectasis
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Recruitment maneuver is frequently used in daily anaesthesia routine to prevent athelectasia and ventilation perfusion mismatch. Especially pneumoperitoneum in laparoscopic surgeries affects the functional residual capacity (FRC) negatively. Recently, FRC can be measured at bedside in intensive care units.

The lack of studies evaluating FRC measurements peroperatively and how recruitment maneuvers affect it, attract attention.

Detailed description: An ICU-ventilator capable to measure the FRC will be used for the mechanical ventilation in patients undergıoing laparoscopic surgery, where anaesthesia maintenance will be achieved with TIVA.

FRC will be measured in different steps of the operation. In the study group, a recruitment manover will be applied to evaluate its effects on FRC.

Eligibility criteria: Inclusion Criteria:

1-18-65 years age 2-no lung disease 3-laparoscopic cholecystectomies surgery

Exclusion Criteria:

1. \<18 years old
2. \>65 years old
3. denial of patient
4. patients having one of: lung disease, cardiac failure, severe cardiac valvular disease

Primary outcomes:
measure: Comparison of FRC measurements at beginning and end of anesthesia
timeFrame: within max 5 minutes after the intubation and with max 5 minutes before the extubation
Secondary outcomes:
measure: Positive room air test
timeFrame: in recovery room 30 minutes after operation
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
city: Istanbul
country: Turkey
facility: Istanbul University, Department of Anesthesiology
Study officials:
affiliation: Istanbul University
name: Elif Aygun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00445237: Evaluation of Deep Transcranial Magnetic Stimulation (TMS) H-Coil in the Treatment of Major Depression
Official title: Evaluation of the H1 Coil and H2 Coil TMS Device - Safety and Feasibility in Major Depression Episode
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depression
Keywords: major depression
TMS
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
Collaborators: name: Brainsway
First posted: 2007-03-08
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is evaluating the safety and feasibility of the novel deep TMS H-coil designs in the treatment of resistant major depression in an open study using two different H-coil designs.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as suffering from treatment resistant major depression

Exclusion Criteria:

* Other axis I diagnosis
* Risk factors for convulsions
* Electroconvulsive therapy (ECT) in the last 9 months
* History of drug abuse in the past year

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata MHC
Study officials:
affiliation: Day care hospital director
name: Hilik Levkovits
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06869837: EOIPB in Laparoscopic Cholecystectomy: Impact on Opioid Consumption Guided by ANI and Analgesia Quality
Official title: Effects of External Oblique Intercostal Plane Block Applied in Laparoscopic Cholecystectomy Surgery on Intraoperative Opioid ConsumptionDetermined by ANI (Analgesia Nociceptive Index) and Postoperative Analgesia Quality Guide; A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain Management
Laparoscopic Cholecystectomy Surgery
Keywords: external oblique intercostal plane block
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 80
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: OTHER

Brief summary: The aim of the study was to evaluate the response of regional anesthesia to remifentanyl consumption in patients undergoing laparoscopic cholecystectomy surgery.

Detailed description: Routine anesthesia and analgesia protocol will be applied to all participants. The study aims to evaluate the remifentanyl consumption of the participants by dividing them into two groups as those with and without block and then performing their monitoring (pulse, mean arterial pressure with noninvasive measurement, oxygen saturation, Analgesia Nociception Index, Bispectral index). Remifentanil level will be adjusted according to the ANI value. The target is to keep the ANI between 50-70.

Eligibility criteria: Inclusion Criteria:

* Participants who will undergo elective laparoscopic cholecystectomy surgery,
* Age 18-70,
* ASA I-II physical status,
* Body mass index (BMI) \< 35 kg/m²,
* Participants who have written consent to participate in the study

Exclusion Criteria:

* Participants with routine analgesic consumption,
* Those with coagulopathy,
* Those with a history of local anesthetic allergy,
* Those with cardiac arrhythmia and pacemaker,
* ASA III and above, Those with dementia

Primary outcomes:
measure: Intraoperative opioid consumption
timeFrame: During surgery
Secondary outcomes:
measure: Numeric rating scale for postoperative pain intensity
timeFrame: up to 24 hours (Will be evaluated at 1, 3, 6, 9, 12, 18, 24 hours)
measure: Quality of Recovery - 15 score
timeFrame: Postoperative 24th hour
measure: Fentanyl consumption at 30 minutes after arrival in the PACU(post anesthesia care unit)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University, Samsun Training and Research Hospital
state: İ̇lkadim
Study officials:
affiliation: SAMSUN UNİVERSITY
name: HALE K CELIK
role: STUDY_DIRECTOR
References:
Clinical trial NCT01502137: Pharmacokinetics of Somatropin in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis
Official title: An Open, Non-randomized, Single-centre, Parallel Group Trial Investigating the Steady-state Blood Concentration Profile and Effects of Once Daily Subcutaneously Injected Recombinant Human Growth Hormone (Norditropin® SimpleXx®) in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis and in Matched Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Kidney Disease
End-Stage Renal Disease
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-30
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to to compare steady-state total growth hormone (GH) exposure in haemodialysis (HD) patients with that of matched healthy subjects.


Eligibility criteria: Inclusion Criteria:

* PATIENTS:
* Male or female, age equal to or above 18 years undergoing chronic haemodialysis
* Stable and adequate haemodialysis treatment three months prior to enrolment
* HEALTHY SUBJECTS:
* Matching an individual of the patient group by: Gender and age (± 5 years)
* Matching an individual of the patient group by weight (after dialysis, ±10%)
* Creatinine clearance above 80 ml/min
* Subjects must be in good health in accordance with their age as determined by a medical
* history, physical examination, vital signs, ECG (electrocardiogram), routine haematology and clinical chemistry

Exclusion Criteria:

* Use of cuprophane membranes
* Active malignant disease
* Diabetes
* Critical illness as defined by the need of respiratory or circulatory support
* Known or suspected allergy to the trial product
* Pregnancy, breast feeding, the intention of becoming pregnant or fertile women judged to be
* using inadequate contraceptive measures
* Blood Pressure (pre-dialysis) above 180/110
* Chronic treatment with steroids in doses above 10 mg/day prednisolone (or equivalent)
* Treated with immunosuppressive agents

Primary outcomes:
measure: Growth hormone exposure at steady state
Secondary outcomes:
measure: Area under the Curve (AUC)
measure: t½ (terminal half-life)
measure: Cmax (maximum plasma concentration)
measure: tmax (time to reach maximum)
measure: IGF-I (Insulin-Like Growth Factor I)
measure: Adverse events (AE)
Other outcomes:
Locations:
city: München
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Langbakke IH, Nielsen JN, Skettrup MP, Harper A, Klitgaard T, Weil A, Engelhardt E, Lange M. Pharmacokinetics and pharmacodynamics of growth hormone in patients on chronic haemodialysis compared with matched healthy subjects: an open, nonrandomized, parallel-group trial. Clin Endocrinol (Oxf). 2007 Nov;67(5):776-83. doi: 10.1111/j.1365-2265.2007.02962.x. Epub 2007 Jul 18.