louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04017702: Detection of Postoperative Respiratory Depression in High Risk Patients Utilizing Minute Ventilation Monitoring
Official title: Detection of Postoperative Respiratory Depression in High Risk Patients Utilizing Minute Ventilation Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Depression
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group A; which will involve pregnant women with gestational age between 32-40 weeks. It will take place at:

i. Labor and delivery floor/obstetric floor: 100 patients scheduled for cesarean section under neuraxial anesthesia with 150 mcg intrathecal or 3-mg epidural morphine.

ii. Antenatal care: (obstetric floor, Long Wharf women clinic, Women center at Yale)

Group B; in post anesthesia care units (PACU) and surgical floor: 100 patients scheduled to receive General Anesthesia (GA) and planned to receive opioid intravenously (boluses/patient controlled analgesia (PCA).

Group C: in step down/ICU; 50 patients suffered from rib fracture and 50 patients after weaning from mechanical ventilation and extubation.

Brief summary: Respiratory volume monitor (RVM) (ExSpiron) is superior to continuous pulse oximetry in detection of postoperative respiratory depression in high risk patients.

Detailed description: Aims are to: 1) Estimate the incidence of postoperative respiratory depression in high risk patients as detected by continuous pulse oximetry 2) Estimate the incidence of postoperative respiratory depression in high risk patients as detected by continuous respiratory volume monitor (RVM) (ExSpiron) 3) Assess the agreement between the continuous pulse oximetry and continuous respiratory volume monitor (RVM) (ExSpiron) in detection of postoperative respiratory depression in high risk patients

Eligibility criteria: Inclusion Criteria:

* Patients who suffered rib fractures or patients who are weaned from mechanical ventilation and recently extubated.

Exclusion Criteria:

* Have known contraindication/allergy to neuroaxial/paravertebral nerve block anesthesia
* Patients allergic to morphine.
* Have an ASA class \> IV

Primary outcomes:
measure: The incidence of postoperative respiratory depression
timeFrame: 1 year
Secondary outcomes:
measure: Detection of postoperative respiratory depression in high risk patients.
timeFrame: 1 year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Aymen Alian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03437902: Impact of Rutin and Vitamin C Combination on Oxidative Stress, Insulin Sensitivity and Lipid Profile in Type 2 Diabetic Patients
Official title: Evaluation of the Impact of Rutin and Vitamin C Combination on Oxidative Stress, Insulin Sensitivity and Lipid Profile in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes
Rutin
Vitamin C
oxidative stress
Insulin resistance
lipid profile
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 53
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the effect ofRutin and Vitamin C combination in comparison with vitamin C alone on the oxidative and antioxidative status , insulin resistance and lipid profile in type 2 diabetic patients.


Eligibility criteria: Inclusion Criteria:

* • Patients' age 35 years or older having type 2 diabetes mellitus.

  * Patients taking oral diabetic medications (Sulfonylurea) not taking Insulin.
  * Able to understand and willing to sign a written informed consent document

Exclusion Criteria:

* • Pregnant and breast feeding females

  • use of vitamin supplements containing vitamin C or other antioxidants.
* patients with renal or hepatic failure.
* patients taking insulin as antidiabetic treatment

Primary outcomes:
measure: Oxidative stress marker (MDA) and antioxidant capacity (SOD) in diabetic patients
timeFrame: Two months
measure: Insulin resistance in diabetic patients .
timeFrame: Two months
measure: Lipid profile in diabetic patients (TC,TG,HDL-c,LDL-c).
timeFrame: Two months
Secondary outcomes:
measure: Quality of life of diabetic patients and this will be evaluated by using Quality of Life Questionnaire (Short Form 36 questions (SF-36)) .
timeFrame: Two months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: sara R Ragheb, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ragheb SR, El Wakeel LM, Nasr MS, Sabri NA. Impact of Rutin and Vitamin C combination on oxidative stress and glycemic control in patients with type 2 diabetes. Clin Nutr ESPEN. 2020 Feb;35:128-135. doi: 10.1016/j.clnesp.2019.10.015. Epub 2019 Nov 14.
Clinical trial NCT02149602: A Phase II Study of Parotid-gland Sparing IMRT in Patients With Midline Tumour of the Head and Neck
Official title: A Phase II Study of Parotid-gland Sparing Intensity-modulated Radiotherapy in Patients With Midline Tumour of the Head and Neck
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oropharyngeal Squamous Cell Cancer
Hypopharyngeal Squamous Cell Cancer
Keywords: involvement of bilateral parapharyngeal spaces
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 120
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: Midline pharyngeal squamous cell cancers (excluding nasopharyngeal cancers)

Brief summary: This study is a phase II trial designed to test the feasibility of delivering IMRT to head and neck cancer patients with tumours arising in the midline (oropharynx and hypopharynx), and to assess possible improvement in reducing the incidence of xerostomia with bilateral superficial lobe parotid sparing IMRT.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed locally advanced HNSCC arising from the oropharynx or hypopharynx with high risk of bilateral parapharyngeal space involvement

Exclusion Criteria:

* Patients \<18 years old or with a previous malignancy other than non-melanomatous skin cancer

Primary outcomes:
measure: The proportion of patients reporting grade 2 or more xerostomia using subjective measure on the LENTSOMA late toxicity scoring scale one year after treatment.
timeFrame: 12 months
Secondary outcomes:
measure: Acute radiation toxicity
timeFrame: 0-3 months
measure: Late radiation toxicity
timeFrame: 3-24 months
measure: Survival outcomes for entire cohort and according to HPV status where available : Local control, Loco regional control, Loco-regional progression-free survival (LRPFS), Disease free survival, Overall survival.
timeFrame: 24 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Head and Neck Unit, Royal Marsden Hospital
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Christopher M Nutting, FRCR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03228602: Impaired Gustatory Sensory Perception in Obese and Obese Diabetic Persons
Official title: Gustatory Evoked Potentials and Cerebral Control of Food Intake in Obese Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Diabetes
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to compare several parameters in three distinct groups of subjects: persons with obesity, persons with obesity and diabetes and persons with neither obesity nor diabetes:

* the electrical activity in response to a sweet solution, measured before and after a standard meal, using gustatory evoked potentials (recording explained below)
* blood hormone levels related to weight gain (insulin, dopamine, ghrelin, leptin: measured in blood samples)
* levels of activity and quantity of an enzyme present in the saliva, amylase, which is able to break down ingested starch into several molecules of glucose.

All of these parameters will be correlated to determine whether the results are different in the 3 groups of subjects in the study.


Eligibility criteria: Inclusion Criteria:

* Patients who have provided written consent
* Patients over 18 years old
* Body Mass Index (BMI) \<25 kg/m² for healthy volunteers and BMI≥30 kg/m² for obese subjects
* Patients with type 2 diabetes for the group "obese diabetic subjects"

Exclusion Criteria:

* Patients under guardianship
* Patients without health insurance cover
* Pregnant or breast-feeding women
* Active smokers
* Subjects with type 2 diabetes for the " healthy subjects " and " obese subjects ", subjects with type 1 diabetes for all groups
* Subjects who do not speak French
* Treatment that interferes with taste or acts on the central nervous system
* Anti-diabetic treatment with GLP-1 analogues (Glucagon-like peptide 1) or SGLT2 (sodium-glucose cotransporter type 2)
* Known hypersensitivity to the foods proposed in the study, or the paste used to fix the electrodes, or to paraffin wax or to the products tested (sucrose, glucose or starch for the gustatory evoked potentials and triangular tests)

Primary outcomes:
measure: Amplitude of the gustatory evoked potential
timeFrame: Up to 10 days
measure: Latency of the gustatory evoked potential
timeFrame: Up to 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT06504602: Pain Elimination and Anxiety Control Through Experiential Virtual Reality
Official title: Pain Elimination and Anxiety Control Through Experiential Virtual Reality
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Procedural Pain
Procedural Anxiety
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 96
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine if active virtual reality is more effective than passive virtual reality and standard of care distraction in decreasing pain in children, from 8 to 21 years old, undergoing intravenous placement in emergency department. The main question\[s\] it aims to answer \[is/are\]:

* Will active virtual reality reduce pain score on Faces Pain Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?
* Will active virtual reality reduce anxiety score on Visual Analog Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?

If there is a comparison group: Researchers will compare active group to passive group and standard of care.

Participants will randomized into active virtual reality, passive virtual reality or standard of care arms.


Eligibility criteria: Inclusion Criteria:

* Children and adolescents 8-21 years old undergoing IV placement .

  * Ability to understand study procedures and to comply with them for the entire length of the study.
  * Participants and caregiver speaking English or Spanish.

Exclusion Criteria:

* Participants with psychiatric, developmental delay, visual or auditory deficits that would interfere with virtual reality gameplay (decision based on treating clinicians' evaluation).

  * Participants receiving narcotics, opioids, or anxiolytics 8 hours prior (Tylenol and ibuprofen do not count).
  * Participants with pain so significant that consent/assent is not possible (decision based on treating clinician evaluation).
  * Critically ill Participants (ESI 1).

Primary outcomes:
measure: Mean Change from Baseline in Pain Scores on Faces Pain Scale - Revised after IV Placement
timeFrame: 5 minutes before, immediately after procedure
Secondary outcomes:
measure: Mean Change from Baseline in Anxiety Scores on Visual Analog Scale after IV Placement
timeFrame: 5 minutes before, immediately after procedure
measure: Mean Change from Baseline in Heart Rate after IV Placement
timeFrame: 5 minutes before, during, and immediately after procedure
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Los Angeles
name: Matan Paret, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04714502: Asphyxia Associated Metabolite Biomarker Investigation 2
Official title: Verification of Biomarkers to Examine Neonatal Asphyxia-induced Hypoxic-ischemic Encephalopathy Study on Neuro-developmental Follow-up at 2 Years A Prospective Multicenter Observational Study for Development of a Diagnostic Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Birth Asphyxia
Keywords: biomarkers
asphyxia
Hypoxic ischemic encephalopathy
Lead sponsor: InfanDx AG
Sponsor class: INDUSTRY
Collaborators: name: Cukurova University
name: University Children's Hospital Tuebingen
First posted: 2021-01-19
Enrollment: 144
Sex: ALL
Minimum age (years): 22
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children, who had been enrolled in the AAMBI study immediately after birth because they had been suspected to be at risk for perinatal brain injury (hypoxic-ischemic encephalopathy, HIE) and/or evaluated for hypothermia therapy or because they had been enrolled in AAMBI as healthy controls (with adaptation disorder only).

Brief summary: Follow-up of participants of AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): Verification of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies.

Detailed description: Follow-Up on neuro-developmental status of Study participants of AAMBI1. AAMBI1(ClinicalTrials.gov ID: NCT03354208): The aim of the study is to verify the application of combinations of several laboratory parameters in early postnatal blood samples, for identification of infants, who will suffer from early abnormal neonatal neurological outcome, in a population at risk. The population at risk is defined as term and late preterm (\>36 weeks of gestation) human infants following perinatal hypoxia-ischemia with or without postnatal resuscitation.

Eligibility criteria: Inclusion Criteria:

* Infants previously enrolled in the AAMBI1 study

Exclusion Criteria:

* Missing valid written informed parental consent

Primary outcomes:
measure: Participants with normal neuro-developmental status
timeFrame: up to 42 month age
measure: Participants with potentially abnormal neuro-developmental status
timeFrame: up to 42 month age
measure: Participants with abnormal neuro-developmental status - HIE
timeFrame: up to 42 month age
measure: Participants with abnormal neuro-developmental status - non-HIE
timeFrame: up to 42 month age
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Turkey Cukurova University
city: Elazığ
country: Turkey
facility: University of Firat
city: Istanbul
country: Turkey
facility: Özel Güngören Hastanesi
city: Mersin
country: Turkey
facility: Mersin University School of Medicine
Study officials:
affiliation: InfanDx AG
name: Ron Meyer
role: STUDY_DIRECTOR
References:
Clinical trial NCT06214702: Serpin C and Soluble Fms-like Tyrosine Kinase-1 Levels in Normotensive Pregnant Women May Predict the Development of Preeclampsia
Official title: Deregulated Serum Levels of Serpin C and Soluble Fms-like Tyrosine Kinase-1 Might Predict the Development of Preeclampsia in Normotensive Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Eclampsia
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were having monthly follow-up of pregnancy and determination of BP measures, and estimation of the serum levels of the studied biomarkers.

Patients who developed GHTN at the 20th GW were grouped as GHTN group and those who were normotensive at the 20th GW were considered as control.

Brief summary: Evaluation of the predictability of estimated levels of Serpin C, sFlt-1 and placental growth factor (PLGF) in blood samples obtained during the 1st trimester from normotensive pregnant women for identification of women liable to develop PE during the course of pregnancy.


Eligibility criteria: Inclusion Criteria:

* Normotensive pregnant women had singleton fetus presenting during the 1st trimester
* free of exclusion criteria

Exclusion Criteria:

* Age
* Sex
* Hypertension

Primary outcomes:
measure: Role of Biomarkers in detection of GHTN
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Banha University
state: El- Qalyobia
Study officials:
References:
Clinical trial NCT04929002: Carbon-13 Magnetic Resonance Spectroscopy in Glycogen Storage Diseases
Official title: Using Carbon-13 Magnetic Resonance Spectroscopy to Assess Whether High Glycogen Levels in Skeletal Muscle of Patients With Glycogen Storage Diseases is a Prelude for Muscle Damage.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glycogen Storage Disease
McArdle Disease
Pompe Disease (Late-onset)
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Research Center for Magnetic Resonance
First posted: 2021-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Pompe or McArdle disease and healthy controls

Brief summary: The project will use carbon-13 magnetic resonance spectroscopy to assess whether high glycogen levels in skeletal muscle of patients with Glycogen Storage Diseases is a prelude for muscle damage.

Patients with Glycogen Storage Diseases will be examined using carbon-13 MR-spectroscopy to quantify the glycogen levels in lumbar, thigh and calf-muscles. The pattern of glycogen concentration will be compared to the pattern of muscle atrophy found in the literature.


Eligibility criteria: Inclusion Criteria:

* Subjects with genetically verified neuromuscular disease or healthy control
* Healthy controls needs to be healthy to be included, evaluated by the investigator

Exclusion Criteria:

* Ferrous objects in or around the body
* Pacemaker or other implanted electronic devices
* Claustrophobia
* Inability to understand the purpose of the trial or corporate for the conduction of the experiments.
* Participation in other trials that may interfere with the results.
* Competing conditions at risk of compromising the results of the study, evaluated by the investigator.
* Strenuous exercise in the preceding 2 days before examination
* Pregnancy or breastfeeding

Primary outcomes:
measure: Glycogen concentration
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Neuromuscular Research Unit, 8077
state: Copenhange
Study officials:
References:
Clinical trial NCT05059002: EpiWatch: Evaluation of a Non-EEG Physiological Signal Based Seizure Monitoring System
Official title: EpiWatch: Evaluation of a Non-EEG Physiological Signal Based Seizure Monitoring System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy, Tonic-Clonic
Keywords: Seizure Detection
Seizure
Digital Health
Lead sponsor: EpiWatch, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-28
Enrollment: 242
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review during patient hospitalization in an epilepsy monitoring unit (EMU).

Detailed description: To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review, during patient hospitalization in an epilepsy monitoring unit (EMU).

Eligible subjects will be issued an EpiWatch device upon admittance into the EMU. The events detected by the EpiWatch will be compared to TC seizures as determined by epileptologists' interpretation of video-EEG recorded for the subject to determine the effectiveness of EpiWatch in detecting TC seizures. EMU standard care practices will not be modified for subjects.

Eligibility criteria: Inclusion Criteria:

* Admitted to a site EMU for video-EEG monitoring
* Age five and older at the time of enrollment
* Has a clinical history of tonic-clonic (TC) seizures or potential for TC seizures
* Willing and able to comply with study procedures

Exclusion Criteria:

* Has participated previously in EpiWatch development studies or contributed any data to the prior development or evaluation of the detector being tested or previous detectors
* Has any condition that would prevent proper wearing of the watch, its free movement during a seizure, or create discomfort from wearing the watch
* Inability or unwillingness to comply with study procedures

Primary outcomes:
measure: Comparison of video-EEG to EpiWatch Results for PPA
timeFrame: 6 months
measure: Comparison of video-EEG to EpiWatch results for FAR
timeFrame: 6 months
Secondary outcomes:
measure: Pediatric Ambulation Positive Percent Agreement
timeFrame: 6 months
measure: Pediatric Ambulation False Alarm Rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Gregory L Krauss, MD
role: PRINCIPAL_INVESTIGATOR
References: