louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04287283: Cognitive Profile of Patients at the Sagol Center for Hyperbaric Medicine and Research
Official title: The Profile of Cognitive Function of Patients Who Had Neurocognitive Evaluation at the Sagol Center for Hyperbaric Medicine and Research
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: TBI (Traumatic Brain Injury)
Stroke
Fibromyalgia
Aging
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-02-27
Enrollment: 2500
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: Retrospective analysis of patients suffering from chronic neuro-cognitive damage or complaints treated at Sagol center for hyperbaric medicine and research, Shamir (Assaf Harofeh) Medical Center, Israel since 2008 .

Brief summary: In the investigator's institute there is ongoing treatment of different patients with cognitive deficits using Hyperbaric oxygen therapy (HBOT). These patients undergo neuro-cognitive function computerized tests before and after treatment.

The aim of this study was to retrospectively evaluate the cognitive changes before and after HBOT in different patients populations.

Detailed description: Retrospective analysis of patients suffering from chronic neuro-cognitive deficits due to different conditions, treated at Sagol center for hyperbaric medicine and research, Shamir (Assaf Harofeh) Medical Center, Israel

Patients included if they had at least two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT). The study was approved by the institutional review board of the hospital.

Patients were treated with 40-60 daily hyperbaric sessions, 5 days per week. Each session consists of 90 minutes exposure to 100% oxygen at 1.5-2 ATA.

Eligibility criteria: Inclusion Criteria:

* Patients included if they completed at least two neuro-cognitive computerized tests, before and after HBOT

Exclusion Criteria:

* Patients who were not able to complete two cognitive tests

Primary outcomes:
measure: Change in neurocognitive scores
timeFrame: baseline and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rishon lezion
country: Israel
facility: hyperbaric center Asaf harofe medical center
Study officials:
References:
Clinical trial NCT04061083: Effects of Endotracheal Tube Cuff Pressure Control on Microaspiration of Gastric Contents
Official title: Effects of Three Endotracheal Tube Cuff Pressure Control on Microaspiration of Gastric Contents: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Ventilator Associated Pneumonia
Nursing Caries
Aspiration, Respiratory
Keywords: Intensive Care
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
name: Afyonkarahisar Health Sciences University Hospital
First posted: 2019-08-19
Enrollment: 135
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 study is to determine effects of three different ET cuff pressure control on microaspiration of the stomach contents.

Detailed description: In the study, ET cuff pressure control will be provided with pilot balloon fingers (Control Group), intermittent with a manometer (Study Group 1) and continuously with a smart cuff manager (Study Group 2).

To assess the effect of different ETT cuff pressure control on microaspiration of the stomach contents, the pepsin level will be measured during deep tracheal secretions. The samples will be examined in the first four hours after intubation, all secretions collected up to the 24th hour of intubation after first sample intake and all secretions collected between 24-48 hours after intubation. Pepsin level will be considered as positive for cut-off point. In addition, the effect of different ETT cuff pressures control on the incidence of VAP will be examined.

Eligibility criteria: Inclusion Criteria:

* Volunteering of the patient or relatives who will participate in the study,
* Patients who require mechanical ventilation support with endotracheal tube supply for 48 hours.

Exclusion Criteria:

* Patients who are contraindicated in giving a semi-fowler position,
* Patients with enteral nutrition contraindications,
* Patients connected to mechanical ventilators for more than 48 hours,
* Patients with tracheostomy,
* Patients admitted to ICU for gastroesophageal reflux disease, aspiration pneumonia or suspicion,
* Nasal endotracheal intubation.

Primary outcomes:
measure: Microaspiration of Gastric Contents
timeFrame: From randomisation to 48 hours after intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Özlem SOYER
state: Center
Study officials:
References:
citation: Er OS, Van Giersbergen MY, Celik S. Effects of three endotracheal tube cuff pressure control measures on microaspiration of gastric content: Study protocol for randomised controlled trial. J Clin Nurs. 2023 Apr;32(7-8):1476-1486. doi: 10.1111/jocn.16493. Epub 2022 Aug 24.
Clinical trial NCT01632683: STorz Against Glidescope Effectiveness
Official title: Comparative Effectiveness of the C-MAC D-blade to Glidescope Videolaryngoscope in the Predicted Difficult Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Airway
Keywords: difficult airway
video laryngoscopy
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: The University of Texas Health Science Center, Houston
First posted: 2012-07-03
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates success rates of tracheal intubation (passing a breathing tube)for patients who may be more challenging to intubate while utilizing one of two devices that facilitate placement of the tube with video technology.


Eligibility criteria: Inclusion Criteria:

* adult 18 years of age
* Mallampati classification scale score of 3 or 4
* Neck circumference greater than 40cm for males, 38 cm for females
* mouth opening less than 3cm, but greater than 2cm

Exclusion Criteria:

* children
* prisoners
* history of easy intubation (success on first attempt with direct laryngoscopy)
* known unstable cervical spine injury
* emergency surgery
* nasal intubation route
* planned awake technique

Primary outcomes:
measure: Intubation Success Rate
timeFrame: 1 week
Secondary outcomes:
measure: Intubation Time
timeFrame: 1 week
measure: Graded Score of Laryngeal View Achieved
timeFrame: 1 week
measure: Number of Particpants Requiring Adjuncts to Assist Intubation
timeFrame: 1 week
measure: Number of Participants With Observed Complications
timeFrame: 1 week
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
citation: Aziz MF, Dillman D, Fu R, Brambrink AM. Comparative effectiveness of the C-MAC video laryngoscope versus direct laryngoscopy in the setting of the predicted difficult airway. Anesthesiology. 2012 Mar;116(3):629-36. doi: 10.1097/ALN.0b013e318246ea34.
Clinical trial NCT00530283: PET-CT for Squamous Cell Carcinoma (SCC) of the Neck Nodes Unknown Primary Malignancy
Official title: The Clinical Utility of PET-CT in the Management of Squamous Cell Carcinoma of the Neck Nodes With Unknown Primary Malignancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Squamous Cell Cancer
Keywords: Squamous
Unknown Primary
Patients with Squamous cell cancer neck nodes
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Calgary Health Region
name: University of Calgary
First posted: 2007-09-17
Enrollment: 20
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: 18 years

Brief summary: Patients with squamous cell cancer of neck nodes but unknown primary will have a PET-CT scan prior to biopsies. The utility of PET-CT will be determined in this subset of patients.


Eligibility criteria: Inclusion Criteria:

* squamous cell cancer of neck nodes with unknown primary site

Exclusion Criteria:

* unable to tolerate PET-CT
* unable to undergo examination under anaesthesia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Harold Lau, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02832583: Autologous Platelet Rich Plasma Combined to Hyaluronic Acid Obtained With Regen-Kit BCT-HA in Aesthetic Medicine
Official title: Efficacy of the Use of Autologous Platelet Rich Plasma Combined to Hyaluronic Acid Obtained With regenKit BCT-HA Cellular Matrix for Skin in Aesthetic Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Wrinkling
Keywords: PRP, hyaluronic acid, mesotherapy, skin wrinkle, skin rejuvenation
Lead sponsor: Regen Lab SA
Sponsor class: INDUSTRY
First posted: 2016-07-14
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this prospective study is to assess the efficacy of autologous Platelet Rich Plasma combined with Hyaluronic Acid prepared with RegenKit-BCT HA Cellular Matrix on skin rejuvenation. Thirty-one patients were included and received three PRP-AH injection sessions 4 weeks apart into the cheeks. The outcomes were assessed at baseline, 1, 3 and 6 months after the last injection session. Safety was assessed by reported adverse event analysis.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 40 years with chronological aging
* Completed informed consent form

Exclusion Criteria:

* Pregnancy or breastfeeding
* Patients younger than 40 years
* Use of product or treatment aimed to improve skin rejuvenation over the last six months before study start,
* patients with known hypersensitivity to HA,
* patients with eczema flare-up,
* patients with active skin disorder infection including herpes virus infection, active hepatitis or human infection virus infection.
* Dermatological diseases affecting the face
* Auto-immune disease such as Hashimoto, rheumatoid arthritis.
* Malignancy with or without metastatic disease
* Chemotherapy
* Anticoagulant therapy

Primary outcomes:
measure: Evaluate the changes of facial apparent overall assessed by FACE-Q scale.
timeFrame: 6 months
Secondary outcomes:
measure: Evaluate the changes of skin elasticity assessed by the Cutometer®
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Hersant B, SidAhmed-Mezi M, Niddam J, La Padula S, Noel W, Ezzedine K, Rodriguez AM, Meningaud JP. Efficacy of autologous platelet-rich plasma combined with hyaluronic acid on skin facial rejuvenation: A prospective study. J Am Acad Dermatol. 2017 Sep;77(3):584-586. doi: 10.1016/j.jaad.2017.05.022. No abstract available.
Clinical trial NCT02001883: Low-dose Statins and Nutraceuticals in High-intensity Statin-intolerant Patients
Official title: Randomized Trial of the Association Between Low-Dose Statins and Nutraceuticals in High-intEnsity Statin-intoleRant patiENts With Very High Risk Coronary Artery diseasE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease, nutraceuticals, statins
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the efficacy and tolerability of low-dose statin therapy vs. the association between a low-dose statin and a nutraceutical-based protocol in high-dose statin-intolerant patients with coronary artery disease deemed to be at high-risk.

Detailed description: Several clinical trials have shown that in patients with atherosclerotic cardiovascular disease, reduction of low-density lipoprotein (LDL) level with a beta-hydroxy-beta-methylglutaryl coenzyme A reductase inhibitor (ie, statin) is associated with significant reductions in both mortality rate and major cardiac events.

Accordingly, current guidelines recommend that high-intensity statin therapy-such as rosuvastatin 20 to 40 mg or atorvastatin 80 mg-should be used to achieve at least a 50% reduction in LDL cholesterol unless otherwise contraindicated.

In real world clinical practice, however, high-intensity statin treatment is often discontinued by patients due to side effects. As alternatives, nonstatin drugs, such as ezetimibe, are often prescribed in association with moderate-to-low intensity statin.

It remains unknown, however, whether the association between moderate-to-low intensity statin therapy and and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions) can have a therapeutic role in high-intensity statin-intolerant patients.

Eligibility criteria: Inclusion Criteria:

* Angiographically-proven coronary artery disease
* Recent (\<12 months) percutaneous coronary intervention
* Class I indication to receive statin treatment to achieve the LDL cholesterol goal of \<70 mg/dL
* Able to understand and willing to sign the informed consent form

Exclusion Criteria:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

Primary outcomes:
measure: Long-term adherence to study treatments
timeFrame: Up to 12 months
Secondary outcomes:
measure: Number of participants with target LDL cholesterol
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University Sapienza
state: Please Select
Study officials:
References:
Clinical trial NCT04396483: Dysfunctional Uterine Bleeding After Tubal Sterilization
Official title: Dysfunctional Uterine Bleeding After Tubal Sterilization and Salpingectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Contraception
Dysfunctional Uterine Bleeding
Keywords: Dysfunctional uterine bleeding
Tubal sterilization
Salpingectomy
Cesarean section
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 220
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, the investigators will compare the frequency and amount of bleeding after tubal sterilization and salpingectomy

Detailed description: Dysfunctional uterine bleeding is common after tubal sterilization.

The investigators will compare the frequency and amount of bleeding after two techniques eithe tubal sterilization by pomeroy's method during cesarean section or complete salpingectomy

Eligibility criteria: Inclusion Criteria:

* Age 20-40
* Patient completed her family
* Patient on cesarean delivery

Exclusion Criteria:

* Tubal sterilization by other methods
* Salpingectomy by laparoscopy
* Patient wishing fertility

Primary outcomes:
measure: Frequency of Dysfunctional bleeding
timeFrame: 1 year after cesarean section
measure: Amount of bleeding
timeFrame: 1 year after cesarean section
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Adel Elgergawy
state: Gharbia
city: Tanta
country: Egypt
facility: Ayman Shehata Dawood
state: Gharbia
Study officials:
References:
Clinical trial NCT00652197: Monitoring Patient Cerebro-Spinal Fluid Drainage With an Ultrasonic Flow Sensor
Official title: A Flow Monitor for Pediatric Hydrocephalic Shunts - Flow Sensor Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocephalus
Keywords: Hydrocephalus
shunt dysfunction
shunt flow
Lead sponsor: Transonic Systems Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-04-03
Enrollment: 16
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric hydrocephalus patients under the care of the Children's Hospital of Wisconsin.

Brief summary: The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in hydrocephalic shunts.

The ultrasonic sensor will measure cerebro-spinal fluid drainage in hydrocephalus patients with external ventriculostomies and extra-ventricular drainage systems. The sensor measurements will be compared with the volume of fluid collected by the drainage bag.

After a 24-hour measurement period, the doctor will change the drainage bag position to simulate the patient sitting up and leaning back, to see if this temporarily stops flow through the drainage line.

This data will show whether the sensor accurately measures typical drainage flows seen in hydrocephalus patients. This research will help develop an implantable flow monitor for pediatric hydrocephalus patients.


Eligibility criteria: Inclusion Criteria:

* Age: newborn through age 20
* Diagnosed with Hydrocephalus
* Instrumented with an Extra-Ventricular Drainage Line

Exclusion Criteria:

* Age: older than age 20
* Not diagnosed with Hydrocephalus
* Not instrumented with an Extra-Ventricular Drainage Line

Primary outcomes:
measure: Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.
timeFrame: 24-hour period
Secondary outcomes:
measure: Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.
timeFrame: 24-hour period
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Transonic Systems Inc.
name: Cornelis J Drost, BS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital and Health System Foundation, Wisconsin
name: Bruce A Kaufman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02260297: A Study of Wrist Actigraphy in Overweight and Obese Adults With Sleep Disorders
Official title: A Study of Wrist Actigraphy in Overweight and Obese Adults With Sleep Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorders
Keywords: Actigraphy
overweight and obese adults
sleep disorders
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
First posted: 2014-10-09
Enrollment: 69
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: Overweight and obese adults with sleep disorders

Brief summary: 70 overweight or obese adults with sleep disorders will be recruited for this study, in which the investigators aim to compare wrist actigraphy with polysomnography (PSG) for sleep monitoring. It is to evaluate the applications of Jawbone Up2 with the sleep parameters derived from this actigraphy.

Detailed description: As an observation study, it will recruit 70 overweight or obese patients with sleep disorders who meet the selection criteria: clinical records and AIS at a tertiary hospital. The patients will sign the informed consent form. The involved patients and doctors will receive related training.

These patients will receive the sleep monitoring from 21:00 to 6:00 in sleep monitoring laboratory in Ruijin Hospital. They will receive the PSG and Jawbone Up 2 sleep monitoring at the same time. Sleep parameters derived from actigraphy and PSG will be compared in multiple night recordings such as total sleep time, wake after sleep onset, sleep onset latency, awakening, sleep efficiency, total time in bed,. The aim is to assess the validation of actigraphy in overweight or obese patients with sleep disorders.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Have one or more sleep disorders such as consecutive snoring, insomnia, sleep apnea, narcolepsy, delayed sleep phase syndrome
* Athens Insomnia Scale (AIS)\>6
* BMI\>25
* Agree to participate in the study and have signed the inform consent form

Exclusion Criteria:

* Terminal illness
* Physically-challenged and paralyzed patients
* Intend to receive selective surgery, to get pregnancy and breast feeding in three months
* Long-term use of the sleeping pills
* Hearing loss or severe visual disorder;
* Mental disorders
* Dementia or communication disorders
* Unable to complete an all night sleep monitoring

Primary outcomes:
measure: Total Sleep Time, TST
timeFrame: 10 hrs
measure: Wake After Sleep Onset, WASO
timeFrame: 10 hrs
Secondary outcomes:
measure: Sleep Onset Latency, SOL
timeFrame: 10 hrs
measure: Frequency of arousal during sleep,awakenings
timeFrame: 10 hrs
measure: Sleep Efficiency, SE
timeFrame: 10 hrs
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: