louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03654846: Video-assisted Telephone CPR With the EmergencyEye-Software - a Pilot Study - Proof of Concept
Official title: Video-assisted Telephone CPR With the EmergencyEye-Software - a Pilot Study - Proof of Concept
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Test of EmergencyEye functionality in real environment, comparison with conventional emergency call.
Primary purpose: OTHER

Brief summary: Technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization of smartphones has opened up new possibilities which surpass the normal audio-only telephony. High quality and real-time video-telephony is now feasible. However until now this technology hasn't been deployed in the emergency respond service.

In the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate and correct via a video-instructed CPR (V-CPR) and to facilitate a fast localization of the emergency site, a new software (EmergencyEye®/RAMSES®) was developed which enables the dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable.

This technology hasn't been tested in a randomized controlled trial in real environment conditions yet. This is to be done in this study.

Detailed description: Technical advance as broad-bandwidth wireless internet coverage and the ubiquity utilization of smartphones has opened up new possibilities which surpass the normal audio-only telephony. High quality and real-time video-telephony is now feasible. However until now this technology hasn't been deployed in the emergency respond service.

In the hope of helping the detection of the cardiac arrest, offer the possibility to evaluate and correct via a video-instructed CPR (V-CPR) and to facilitate a fast localization of the emergency site, a new software (EmergencyEye®/RAMSES®) was developed which enables the dispatcher a video-telephony with the callers mobile terminal (smartphone) if suitable, and automated localisation of the caller.

This technology hasn't been tested in a randomized controlled trial in real environment conditions yet. This is to be done in this study.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* cardiovascular diseases
* pulmonary diseases
* pregnancy
* all other conditions that make CPR impossible

Primary outcomes:
measure: Recognition of CPR quality through video transmission
timeFrame: 1 minute of CPR
Secondary outcomes:
measure: Time to first chest compression
timeFrame: Study duration (approx. 1 minute)
measure: Precision of Geolocalisation
timeFrame: Study duration (approx. 1 minute)
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Department of Anaesthesiology and Critical Care Medicine, University Hospital of Cologne
Study officials:
References:
Clinical trial NCT01175746: The Effect of Nicardipine on Kidney Function During Orthognathic Surgery Under Hypotensive Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: healthy adult patients
ASA class I
hypotensive anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-08-05
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Since nicardipine is known to protect kidney function, nicardipine infusion will result in better renal parameters measured in this study.


Eligibility criteria: Inclusion Criteria:

* healthy adult patients undergoing hypotensive anesthesia

Exclusion Criteria:

* patients with any co-morbidity

Primary outcomes:
measure: Creatinine Clearance
timeFrame: 2hr after the start of hypotensive anesthesia
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Severance hospital, YUHS
name: Ji Young Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02454946: Blood Types and Erectile Dysfunction
Official title: The Relation Between ABO Blood Types and Erectile Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Keywords: Blood Group Antigens
erectile dysfunction
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 102
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Administered to urology polyclinic between April 2013 and April 2014. Sexually active 102 patients whose blood types were known were included in this study.

Brief summary: The researchers aimed to investigate the relationship between ABO blood types and erectile dysfunction.

Detailed description: This retrospective study is done in Ordu university Hospital among patients who administered to urology polyclinic between April 2013 and April 2014. Sexually active 102 patients whose blood types were known were included in this study. While 56 patients had sexual intercourse problems 46 had not and this group was taken as a control group. Individuals who had a sexual partner and whose sexual intercourse were continuing unproblematic ally were accepted as normal. Individuals who had not have sexual intercourse though having a sexual partner or unable to maintain the intercourse were accepted to have sexual dysfunction. Patients' sexual function was evaluated via the İEFF-5 questioning form. In the same session the patients' blood types were also recorded and their İEFF-5 (Erectile Function International Evaluation Form) symptom scores were compared with their blood types.

Eligibility criteria: Inclusion Criteria:

* Male, person who have sexual intercourse

Exclusion Criteria:

* Female, who have no sexual intercourse

Primary outcomes:
measure: The relationship between erectile dysfunction and blood group antigens
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: researcher
name: Yasemin kaya, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaya A, Tanboga IH, Kurt M, Isik T, Kaya Y, Gunaydin ZY, Aksakal E. Relation of ABO blood groups to coronary lesion complexity in patients with stable coronary artery disease. Anadolu Kardiyol Derg. 2014 Feb;14(1):55-60. doi: 10.5152/akd.2013.4728. Epub 2013 Dec 9.
Clinical trial NCT01456546: Impact of CYP2C19*17 on the Pharmacokinetics of Proguanil and Clopidogrel
Official title: Impact of CYP2C19*17 on the Pharmacokinetics of Proguanil and Clopidogrel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: CYP2C19 Genotypes
Keywords: CYP2C19*17
Pharmacokinetics
Pharmacodynamics
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2011-10-20
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate if the genetic variant CYP2C19\*17 affects the pharmacokinetics of proguanil and clopidogrel.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Written consent
* Age 18-65
* CYP2C19\*1 and or CYP2C19\*17 genotype.

Exclusion Criteria:

* Daily medication
* Alcohol abuse
* Pregnancy
* Breastfeeding

Primary outcomes:
measure: Proguanil pharmacokinetics. Primary endpoint is cycloguanil formation clearance.
timeFrame: Hours after administration: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 10, 24, 31, 48, 55
Secondary outcomes:
measure: Pharmacokinetics of the derivatised active clopidogrel metabolite.
timeFrame: Hours after administration: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Clinical Pharmacology, University of Southern Denmark
state: Fyn
Study officials:
References:
Clinical trial NCT04826146: Pediatric Validation of CONOX Monitor During Surgery
Official title: Monitoring the Depth of Anesthesia Using the qCON and qNOX Indices During Pediatric Surgery: a Multi-centre Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Anesthesia Awareness
Nociceptive Pain
Pediatric ALL
Surgery
Pain
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 65
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing general anesthesia for a surgical procedure longer than 60 minutes

Brief summary: Pediatric Validation of CONOX Monitoring device (qCON and qNOX indices) for anesthesia depth during surgery


Eligibility criteria: Inclusion Criteria:

* General Anesthesia using propofol, sevoflurane or desflurane
* ASA I - IV
* Surgical procedure longer than 60 minutes

Exclusion Criteria:

* Neurological disorders
* Inability to correctly place BIS and CONOX probes in forehead
* Pregnancy
* Active prescription for drugs involving chronic pain and / or central nervous system
* Hemodynamic instability

Primary outcomes:
measure: Correlation of qCOX and BIS values
timeFrame: prospective data acquisition through study completion, an average of 1 year
Secondary outcomes:
measure: Correlation of qNOX and MOAA/S values
timeFrame: prospective data acquisition through study completion, an average of 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Santiago De Compostela
country: Spain
facility: Hospital Universitario de Santiago de Compostela (CHUS)
Study officials:
References:
Clinical trial NCT06084546: Geko™ KM40C Hydrogel Skin Adhesion Trial (XW-3)
Official title: Evaluation of the Adhesive Strength of an Improved Skin Adhesive Hydrogel Formulation Designated KM40C Incorporated in the Geko™ X-W3 Neuromuscular Electrical Stimulator (NMES) Device in Patients With Lower Limb Ulcers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Leg Ulcer
Keywords: geko
NMES
Lead sponsor: Firstkind Ltd
Sponsor class: INDUSTRY
First posted: 2023-10-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Hydrogel KM40C is an electrically conductive skin adhesive incorporated in the self-adhesive, geko™ XW-3 neuromuscular electrical stimulation (NMES) device. KM40C has been formulated to adhere to the skin giving good electrical contact for the electrodes, be easy to remove without damaging the skin and be non-irritant. KM40C has been tested for safety in humans, however the skin adhesive performance of this improved hydrogel formulation has not been tested on patients receiving geko™ NMES treatment as an adjunct to standard care for wound management.

The objective of this trial is to evaluate the skin adhesive performance of hydrogel KM40C during clinical use of the geko™ XW-3 NMES device to determine whether skin adhesion is at least equivalent if not superior to the adhesive hydrogel KM40A incorporated in the self-adhesive geko™ W3 device which is currently in use clinically. Both devices are indicated for use to promote wound healing, the geko™ W3 NMES device is UKCA and CE marked whereas the geko™ X-W3 is UK CA marked only.


Eligibility criteria: Inclusion Criteria:

1. Adult over 18.
2. Patients who have a lower limb ulcer following evaluation by a Tissue Viability Nurse Specialist
3. Intact healthy skin at the site of geko™ device application.
4. Willing and able to give written informed consent
5. Identified to receive geko™ treatment as an adjunct to standard care for wound management.

Exclusion Criteria:

1. Pregnancy or breast feeding
2. Use of any other neuro-modulation device.
3. Use of a cardiac pacemaker
4. Current use of TENS in the pelvic region, back or legs
5. Contraindication to geko ™ NMES treatment
6. No response to geko ™ NMES i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting.
7. Participation in any other clinical trial that may interfere with the outcome of either trial.

Primary outcomes:
measure: Efficacy of the Skin Adhesive Strength of Hydrogel KM40C Compared to That of Hydrogel KM40A
timeFrame: 28 days
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: 28 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Central London Community Health Care NHS Trust
city: Norwich
country: United Kingdom
facility: Norfolk Community Health and Care NHS Trust
Study officials:
affiliation: St Charles Centre for Health & Wellbeing
name: Agnes Collarte
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02669446: Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis
Official title: Non Interventional Clinical Investigation of Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Viral Pharyngitis
Keywords: Non interventional study
Ectoin
Lozenges
pharyngitis
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2016-02-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with viral pharyngitis

Brief summary: This a comparative, open label, parallel group, non interventional study which compares the tolerability and influence of Ectoin containing Lozenges to saline solution and lozenges containing hyaluronic acid for the treatment of acute viral Pharyngitis. The observation takes place over a period of 7 days. Response to treatment is recorded at day 1 and day 7 by the physician and by the patient in a dairy.


Eligibility criteria: Inclusion Criteria:

* Patients with acute Pharyngitis according to instruction for use
* Female or male individuals ≥ 18 years
* Agreement to abide by the routinely provided doctor's appointment for follow- up (reflected in the planned visits of observation plan resist)

Exclusion Criteria:

* Contraindications according to instructions for use
* Male or female person under 18 years
* Sore throat for more than 5 days
* Any disease that can, in the opinion of the treating physician to affect the outcome of the study.
* Patients with known intolerance to one of the substances used
* Surgical procedures to the mouth and throat in the last 6 weeks before inclusion in the NIS
* Bacterial Pharyngitis
* Pregnancy

Primary outcomes:
measure: Change in Pharyngitis symptom score evaluated by the physician
timeFrame: day 1 and day 7
Secondary outcomes:
measure: Change in Pharyngitis symptoms evaluated on patient´s diaries
timeFrame: 7 days
measure: Change in patient´s General condition evaluated by the physician
timeFrame: day 1 and day 7
measure: Patient´s Evaluation of tolerability
timeFrame: 7 days
measure: physician´s Evaluation of tolerability
timeFrame: day 7
measure: Change in number and type of adverse Events
timeFrame: 7 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: HNO-Praxis Mahlstedt
city: Elmshorn
country: Germany
facility: HNO-Praxis Elmshorn
city: Lüneburg
country: Germany
facility: HNO-Praxis Möller
city: Norderstedt
country: Germany
facility: HNO-Praxis
Study officials:
affiliation: HNO-Praxis
name: Uwe Sonnemann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05290246: TRE in Type 2 Diabetes (See Food Study 3)
Official title: TRE in Type 2 Diabetes Mellitus (See Food Study 3)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type2Diabetes
Keywords: Type 2 diabetes
diet intervention
intermittent fasting
caloric restriction
time restricted eating
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hyperglycemia in patients with Type 2 Diabetes Mellitus is initially treated with metformin coupled with intentional caloric restriction, which is difficult to sustain due to multiple barriers, including acquiring the necessary knowledge, teaching the intervention, cost of delivery and potential burden on quality of life. In contrast to intentionally restricting calories, time restricted eating (TRE), presents a simplified view of eating focused on restricting the eating window, which allows ad libitum intake per a person's dietary preferences during a daily fixed eating window. This study proposes a 24 week feasibility study to test if TRE is a viable alternative to Caloric Restriction in improving glycemic measures while accounting for weight loss in overweight/obese patients \[BMI:25-45 kg/m2\] with metformin-only treated Type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Overweight/obese adults with metformin-only treated type 2 diabetes
* 18-65 years old
* BMI:25-45 kg/m2
* HbA1c: 6.5-8.5%
* Self-reported weight must be stable \[±5 pounds\] for at least 3 months prior to the study
* Owns a smartphone.

Exclusion Criteria:

* Active or anticipated pregnancy during the study
* type 2 diabetes treated with medications other than metformin
* presence of eating disorders as noted by screening survey.

Primary outcomes:
measure: Change in glycemic measures- HbA1c (12w)
timeFrame: 12 weeks
Secondary outcomes:
measure: Weight change (12w)
timeFrame: 12 weeks
measure: Weight change (24w)
timeFrame: 24 weeks
measure: Change in glycemic measures- insulin (12w)
timeFrame: 12 weeks
measure: Change in glycemic measures- insulin (24w)
timeFrame: 24 weeks
measure: Change in glycemic measures- Homeostatic Model Assessment for Insulin Resistance (24w)
timeFrame: 24 weeks
measure: Change in glycemic measures- Homeostatic Model Assessment for Insulin Resistance (12w)
timeFrame: 12 weeks
measure: Change in glycemic measures- HbA1c (24w)
timeFrame: 24 weeks
measure: Change in glycemic measures- glucose (24w)
timeFrame: 24 weeks
measure: Change in glycemic measures- glucose (12w)
timeFrame: 12 weeks
measure: Intervention burden (12w)
timeFrame: 12 weeks
measure: Intervention burden (24w)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota- Division of Endocrinology, Diabetes, and Metabolism
name: Lisa Chow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05350046: Development of Physical Activity Features for Ear-worn Devices
Official title: Development of Physical Activity Features for Ear-worn Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Well Aging
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: Philips BioTelemetry Research
name: Trialfacts
First posted: 2022-04-27
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study incorporates data collection to aid in development of software features related to physical activity for users of ear-worn devices.

Detailed description: This exploratory study involves data collection of adults performing physical activities and activities of daily living for the purpose of comparing data collected by the ear-worn device under test and established gold standard/reference devices and consumer electronic devices. Data collected will be used in the development of software features related to physical activities to benefit the experience of ear-worn device users.

Eligibility criteria: Inclusion Criteria:

* Age 40 - 85
* Minimum height 5'3"
* Fully vaccinated against Covid -19
* Willing and able perform various exercise activities at a light and moderate relative intensity, such as riding a stationary bike, walking and jogging on a treadmill, and performing squatting movements.
* Non-smoker for the past 6 months.
* Willing to abstain from caffeine and alcohol 6 hours before participation.
* Willing to fast from eating 4 hours before participation.

Exclusion Criteria:

* History of chronic heart disease or significant cardiac events (e.g. cardiac arrythmia).
* Diagnosed with diabetes mellitus or other metabolic disorder.
* History of cerebral vascular accident.
* History of pulmonary disorder.
* Experiencing orthopedic injury or disorders that restrict movement or cause painful physical activity.
* History of neurodegenerative or neuromuscular pathology.
* Advised by a healthcare professional to not participate in physical activity.

Primary outcomes:
measure: Accuracy of ear-worn device information
timeFrame: data collection during activities ranging in duration from 5-20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Sonova Silicon Valley
state: California
Study officials:
affiliation: Sonova USA Inc
name: Christopher Ross, MS
role: STUDY_DIRECTOR
References: