louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03452163: Performance Assessment of the PMD-200 in Subjects at Neurointensive Care Unit
Official title: Performance Assessment of the Physiological Monitor Device (PMD-200), a Novel Pain Monitor, in Subjects at Neurointensive Care Unit (NICU).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anesthesia, General
Lead sponsor: Medasense Biometrics Ltd
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Performance Assessment of the PMD-200, a Novel Pain Monitor, in Subjects at Neurointensive Care Unit.

Detailed description: The proposed study is design to further demonstrates the performance of the Nociception Level (NoL) Index in neurological impaired anesthetized patients under general anesthesia, by evaluating its response to controlled changes in the levels of noxious stimuli/analgesia, and to correlate the NoL response to the EEG derived pain score. Validating the performance of the NoL Index may provide a tool to monitor the pain/nociception in this population.

In this study, the PI plan to demonstrate that the NoL Index is a continuous index. It is anticipated that a higher level of nociception will correspond to a higher NoL index. On the other hand, it is anticipated that higher levels of analgesic agent for the same noxious stimulus will lead to a lower NoL index.

The participants will be monitored as in a typical ICU and according to the local guidelines by various types of monitoring devices, such as: vital signs, pulse oximeter, Bispectral Index (BIS), Electroencephalography (EEG) etc.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old.
* The subject is under general anesthesia
* The subject have a blood pressure measurement (either arterial or cuff) during the study
* A signed Informed Consent Form (ICF) has been obtain

Exclusion Criteria:

- The subject is constantly agitate or moving a lot

Primary outcomes:
measure: Correlation between changes in the nociception levels of the subject (NoL Index value) prior and following a noxious stimuli
timeFrame: Through study completion, about one year
Secondary outcomes:
measure: Correlation between changes in the nociception levels of the subject (NoL Index value) to other nociception predictors (HR, NIBP)
timeFrame: Through study completion, about one year
measure: Correlation between the NoL index and the EEG derived pain score
timeFrame: Through study completion, about one year
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Galil Medical Center
Study officials:
affiliation: Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel
name: Jean Soustiel, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05266963: Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes
Official title: Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type 1 Diabetes
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will receive CREON and placebo in a random, blinded order.
Primary purpose: TREATMENT

Brief summary: Recent studies have demonstrated reduced pancreatic volume is present within months of T1D diagnosis in children, adolescents, and adults. As the pancreatic beta cells constitute only 1-2% of the pancreas, the degree of reduction in pancreas volume at disease onset suggests exocrine involvement, challenging the established paradigm of T1D being solely a disease of the endocrine pancreas.

To date there has not been an investigation of the potential for pancreatic enzyme replacement therapy in the management of T1D. In individuals with cystic fibrosis-related diabetes, enzyme replacement has been shown to reduce post-prandial glycemia excursions, which are reflected in improved GLP-1 responses to mixed meal tolerance testing. As post-prandial excursions and glucose variability are a significant challenge in T1D, how enzyme replacement may impact these parameters is an important question.

The investigators hypothesize that patients with T1DM who have reduced pancreatic volume will have improved glycemic responsiveness, reduced hypoglycemia, and improved symptoms of pancreatic exocrine insufficiency when treated with pancreatic enzyme replacement (CREON).


Eligibility criteria: Inclusion Criteria:

* Currently receive care at the Eskind Diabetes Clinic at Vanderbilt University Medical Center
* Diagnosed with T1DM for at least 12 months
* Age over 18
* Total daily dose of insulin greater than 0.7u/kg/day
* Current use of a continuous glucose monitor
* Current use of smart phone
* Able to read and speak English
* Willingness and ability to download and provide CGM and pump (if applicable) data
* Reduction of pancreas volume (\<0.6mL/kg body weight)

Exclusion Criteria:

* History of celiac disease or inflammatory bowel disease
* Use of medication or supplements other than insulin to control blood glucose
* Pregnancy or breast feeding
* Following a restrictive diet (such as very low carb diet)

Primary outcomes:
measure: Improvement in Glucose Regulation
timeFrame: through study completion (4-5 weeks)
measure: Patient-reported Change in Pancreatic Exocrine Insufficiency (PEI) Symptoms
timeFrame: through study completion (4-5 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Daniel Moore, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04467463: Peripheral Nerve Block Techniques During Cleft Palate
Official title: Comparing Two Peripheral Nerve Block Techniques for Perioperative Analgesia During Cleft Palate Surgery in Pediatric Patients: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: Suprazygomatic
Maxillary
Palatine
Cleft Palate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The two study groups were:

* Group GPN, 20 patients received bilateral greater palatine nerve block.
* Group SMN, 20 patients received bilateral suprazygomatic maxillary nerve block.
Primary purpose: PREVENTION

Brief summary: Regional blocks are commonly used in pediatric anesthesia to achieve adequate postoperative analgesia. Suprazygomatic Maxillary nerve block (SMN) and Greater Palatine nerve block (GPN) are regional blocks described for use during cleft palate (CP) repair surgery.The aim of this study was to compare the analgesic effect as well as the incidence of complications associated with the use of bilateral GPN and bilateral SMN blocks in children undergoing palatoplasty surgery.


Eligibility criteria: Inclusion Criteria:

* ASA I-III scheduled to undergo palatoplasty

Exclusion Criteria:

* bleeding disorders,
* skin lesions or wounds at site of proposed needle insertion,
* congenital heart disease,
* respiratory or
* cardiovascular disorders,
* children scheduled for combined procedures like palatoplasty with cheiloplasty or submucosal alveolar bone grafting,
* known hypersensitivity to local anesthetics or opioids and
* lack of parental consent.

Primary outcomes:
measure: postoperative pain score
timeFrame: the first 12 postoperative hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University hospitals
state: Manial
city: Cairo
country: Egypt
facility: anesthesia department at Cairo University
Study officials:
References:
citation: Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. No abstract available.
citation: Lee SJ, Ralston HJ, Drey EA, Partridge JC, Rosen MA. Fetal pain: a systematic multidisciplinary review of the evidence. JAMA. 2005 Aug 24;294(8):947-54. doi: 10.1001/jama.294.8.947.
citation: 3. Tremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.
citation: Diewert VM. Development of human craniofacial morphology during the late embryonic and early fetal periods. Am J Orthod. 1985 Jul;88(1):64-76. doi: 10.1016/0002-9416(85)90107-1.
Clinical trial NCT04377763: Developement and Evaluation of Serological Assays for COVID-19
Official title: Developement and Evaluation of Serological Assays for COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: COVID-19
serological assay
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with positive or negative molecular diagnosis of Covid-19, in the Laboratory of Microbiology of Ambroise Paré Hospital.

Brief summary: The primary objective of the study aims to evaluate serological assays of virus Covid-19.

Detailed description: This is a retrospective monocentric study, which will include the patients who have hospitalized in Ambroise Paré Hospital and have sampling sent to the Laboratory of Microbiology of the hospital between the 15 March 2020 and 30 september 2020.

Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years;
* Have molecular diagnosis of positive or negative result in Covid-19 virus by the Laboratory of Microbiology in Ambroise Paré Hospital;
* Have diagnosed of a viral infection in respiratory.

Exclusion Criteria:

- Patient refusal.

Primary outcomes:
measure: Sensibility and specificity
timeFrame: Throughout of the study, an average of 6 months
Secondary outcomes:
measure: Delay between the first symptoms and the positive serological result
timeFrame: Throughout of the study, an average of 6 months
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Laboratory of microbiology of hospital hygiene, Ambroise Paré Hospital, APHP
Study officials:
affiliation: Laboratoire de Microbiologie Hygiène hospitalière, Hôpital Ambroise paré, APHP
name: Marie-Anne RAMEIX-WELTI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04190563: Pain, Inflammation and Opioid Craving
Official title: Affective and Inflammatory Reactivity to Pain in Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to investigate the association between response to pain and opioid craving in people with opioid use disorder. In this study, adults with opioid use disorder will be randomized to one of two brief education sessions followed by an assessment of response to pain. Investigators will test the association between response to pain and opioid craving.


Eligibility criteria: Inclusion Criteria:

* age 18 years or older;
* diagnosis of opioid use disorder
* chronic pain
* ability to read and provide informed consent

Exclusion Criteria:

* major psychiatric or medical condition that would interfere with participation
* current opioid withdrawal
* currently receiving opioid analgesic medication for pain
* recent history of myocardial infarction or other serious cardiovascular condition
* current peripheral neuropathy, active vasculitis or severe peripheral vascular disease
* systematic inflammatory or autoimmune disorder
* admitted to current treatment episode on an involuntary status

Primary outcomes:
measure: Craving
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Rebecca K McHugh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01519063: Naltrexone and Memantine Effects on Alcohol Drinking Behaviors
Official title: Glutamate-opioid Interactions in Alcohol Drinking Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Drinking
Keywords: Alcohol
Drinking
Drinkers
Alcohol Drinking
Memantine
Naltrexone
Alcohol Dependence
Alcohol Abuse
Alcohol-Related Disorders
Ethanol
Alcoholism
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2012-01-26
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the combined effects of the study medications naltrexone and memantine on alcohol drinking behaviors.

Detailed description: Participants will be randomized to receive a combination of naltrexone/memantine over a one week period and then participate in a laboratory session. During this session, participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. These medications are hypothesized to reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period.

Eligibility criteria: Inclusion Criteria:

* Ages 21-55
* Able to read English at 6th grade level or higher and to complete study evaluations
* Regular alcohol drinker

Exclusion Criteria:

* Individuals who are seeking alcohol treatment
* Medical conditions that would contraindicate the use of study medication
* Regular use of other substances

Primary outcomes:
measure: Number of Drinks Consumed at Lab Session (Day 7)
timeFrame: Day 7
measure: Craving AUC: Adlib Drinking Phase
timeFrame: 50-230 minutes after the priming drink during lab session
measure: Stimulation Response to Alcohol at Lab Session
timeFrame: 50-230 minutes after the priming drink during lab session
measure: Sedation Response to Alcohol at Lab Session
timeFrame: 50-230 minutes after the priming drink during lab session
measure: Craving AUC: Priming Dose Phase
timeFrame: 0-50 minutes after the priming drink
measure: Sedation Response to Alcohol: Priming Dose Phase
timeFrame: 0-50 minutes after priming drink
measure: Stimulation Response to Alcohol: Priming Dose Phase
timeFrame: 0-50 minutes after priming drink
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Sac, Cmhc
state: Connecticut
Study officials:
affiliation: Yale University
name: Suchitra Krishnan-Sarin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02115763: The Effects of Caffeine on Pain-Based Pacing During a Cycling Time-Trial
Official title: The Effects of Caffeine on Pain-Based Pacing During a Cycling Time-Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: physically active,
18-35 year old men
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Caffeine has been shown to consistently improve time-trial performance, warranting restrictions on consumption under regulation of the National Collegiate Athletics Association (NCAA) and World Anti-Doping Agency (WADA). This ergogenic effect is not well understood, possibly occurring as a result of altered metabolism, improved strength, and/or reduced muscle pain. The hypothesis of altered metabolism has recently fallen out of favor while muscular strength has a tenuous relationship with endurance exercise performance. Reductions in muscle pain have been observed during low and moderate intensity endurance exercise, and this may be the mechanism of caffeine's ergogenic effect. In lieu of reducing pain during high intensity exercise, caffeine significantly improves performance. Therefore, caffeine appears to improve the amount of work that can be done for a given muscle pain rating, suggesting that participants may pace based upon sensations of muscle pain during endurance exercise. Most time-trial exercise is conducted in a fixed distance manner, measuring the time it takes participants to cover a given distance. Little research has been conducted on a fixed pain time-trial that would require participants to produce and sustain a given level of muscle pain while measuring the distance covered in an allotted time. A fixed pain time-trial could allow researchers to better understand the effect of pain on endurance performance. The purpose of this study is to examine the effects of caffeine on a fixed pain time-trial.


Eligibility criteria: Inclusion Criteria:

* Caffeine Naive (\<40mg per day) physically active 18-35 year old men with no contraindications to exercise.

Exclusion Criteria:

* People who do not match the gender, age or caffeine limits;
* those with contraindications to exercise or who are not physically active

Primary outcomes:
measure: Stationary Cycle Ergometer
timeFrame: 30 minutes per session (6 sessions total)
Secondary outcomes:
Other outcomes:
Locations:
city: Norman
country: United States
facility: University of Oklahoma Sensory and Muscle Function Lab
state: Oklahoma
Study officials:
References:
Clinical trial NCT00625963: The Study Of CT Scans and Echo Parameters in Patients With PAH
Official title: The Study of CT Scan and Echocardiogram Parameters in Patients With Pulmonary Hypertension With Regards to Hemodynamics, Sleep Studies, and Various Laboratory Markers.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Hypertension;
ILD;
CT Imaging;
Echocardiogram;
Hemodynamic measurements of RHC.
Pulmonary Function Tests
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2008-02-29
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pulmonary Arterial Hypertension; Idiopathic Lung Disease

Brief summary: Current standard of the diagnosis and monitoring of PHNT requiring combination of invasive and non-invasive tests. The goal of the study is to correlate data from CT scans, echocardiograms, right heart catheterization, PFTs, sleep studies, and perfusion scans. The ultimate goal is to determine patterns of the PAH disease processes.

Detailed description: The goal of our study is to correlate data from various non-invasive tests such as commuted tomography (CT) imaging, echocardiogram, Pulmonary Function Tests, and other laboratory tests along with hemodynamic measurements from Right Heart Catheterizations in these ILD patients with Pulmonary Hypertension, as well as all other pulmonary hypertension. The ultimate goal is to determine patterns of the PAH disease processes, as well as define optimal diagnostic modalities including in-hospital verses outpatient studies.

Eligibility criteria: Inclusion Criteria:

* Pulmonary Hypertension;
* ILD with Pulmonary Hypertension

Exclusion Criteria:

* NON-PH

Primary outcomes:
measure: The Study Of CT Scans and Echo Parameters in Patients With PAH
timeFrame: All data has been previously collected.
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: North Shore-Long Island Jewish Health System
state: New York
Study officials:
affiliation: Northwell Health
name: Arunabh Talwar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03140163: Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]
Official title: Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT and Conventional Chest Radiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumonia
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 100
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: The ULTRACHEST study will be a prospective clinical diagnostic performance study with primary objective to establish device diagnostic clinical performance of Ultra Low Dose CT (ULD-CT) in order to prove it is more accurate in detecting pneumonia when comparing to standard conventional chest radiography.

Detailed description: * 200 subjects
* Each subject will undergo CXR and ULD-CT at the same day.
* Subjects subdivided into 3 groups \[high, moderate and low risk\], based on a laboratory finding(CRP), symptoms and physical examination.
* 3 different thoracic radiologist will judge the scans on existence of consolidation. Consolidation will be expressed as binary outcomes (Yes or No consolidation)
* Radiologist will be blinded for subjects demographic data.
* All radiologist have to score how confidence they were on the finding of consolidation\[5point likert\].
* The investigators will perform a McNemar's test for evaluation. A two sided p-value of less than 0.05 will be considered to be statistically significant.
* Inter-observer variability will be evaluated by using a Fleiss Kappa test.

Eligibility criteria: Inclusion Criteria:

* Suffering from pneumonia and referred by their GP

Exclusion Criteria:

* Younger than 18
* Known pregnancy
* Not able to sign the Informed Consent document
* If not willing to be informed about additional findings

Primary outcomes:
measure: Three different radiologists will be asked to fill in a questionaire on whether or not there is presence of consolidation (yes/no) on both ULD-CT, as well as on CXR.
timeFrame: 2 years
measure: Risk assessment of having a pneumonia for each subject
timeFrame: 2 year
measure: 5 point likert scale to evaluate the "level of confidence" of each radiologist
timeFrame: 2 year
Secondary outcomes:
measure: All 3 radiologist will be asked to write down on paper if they see an additional finding on either the ULD-CT or CXR
timeFrame: 2 years
measure: In case the radiologist observes an additional finding, the radiologist has to fill in a questionaire on paper what kind of additional finding was seen:
timeFrame: 2 year
measure: Reporting the total number of observed additional findings for each modality [ULD-CT and CXR], based on the above mentioned questionaires
timeFrame: 2 year
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MUMC
state: Limburg
Study officials:
affiliation: Maastricht University Medical Centre
name: Marco Das, Dr
role: PRINCIPAL_INVESTIGATOR
References: