louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04692064: mCVI Confirmatory Clinical Study: Algorithm Verification
Official title: A Single-Center, Prospective Clinical Study to Demonstrate That mCVI® Accurately Captures Pulse Rate and Respiratory Rate in 20 Healthy Volunteers in Comparison to Commercially- Available Masimo Pulse Oximeter Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Algorithm Verification
Lead sponsor: Intelomed, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-31
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: This single center confirmatory clinical study is to verify the algorithm of mCVI® to accurately capture pulse rate and respiratory rate in 20 healthy subjects in comparison to commercially-available Masimo pulse oximeter devices. This is a non significant risk device.

Detailed description: In this confirmatory clinical study the mCVI® device is a mobile application used to simply verify the algorithm when the mobile video reads a patients pulse rate and respiratory rate while spontaneously breathing. There is no facial recognition technology. There is no immediate feedback given to the research team to act upon or provide for further clinical care decisions. In real time, the mCVI® device will be compared to two commercially available Masimo pulse oximeter devices in a single visit.

Eligibility criteria: Inclusion Criteria:

* Healthy adults between the ages of 21 - 70

Exclusion Criteria:

* Medical conditions that could compromise a participant's ability to provide for all breathing samples, pedal the Cubii Pro elliptical, or follow instructions
* Medications that could compromise a participant's ability to participate in the study
* Documented medical history of respiratory or cardiovascular disease
* Excessive facial hair, facial deformities, or obstructions (like glasses or face masks/shields) that could compromise the recording of pulse rate and respiratory rate of the mCVI®
* Any face lotions or make up foundations that could compromise the recording of pulse rate and respiration rate of the mCVI®
* Missing digits or fingers on one or more hand that would prevent proper recording of Masimo pulse oximeter devices
* Participants wearing nail polish, acrylic nails, or rings on the ring finger of either hand that would prevent the proper use of Masimo pulse oximeter device
* Recent (≤ 1 month) surgical procedure of any kind
* Current participation in another investigational clinical trial
* Inability to provide informed consent

Primary outcomes:
measure: Pulse Rate Verification
timeFrame: 2 months
measure: Respiration Rate Verification
timeFrame: 2 months
Secondary outcomes:
measure: Skin Tone Pulse Rate Verification
timeFrame: 2 months
measure: Skin Tone Respiration Rate Verification
timeFrame: 2 months
Other outcomes:
Locations:
city: Cranberry Township
country: United States
facility: InteloMed, Inc.
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03185364: The Safety and Efficiency of Sildenafil in the Treatment of Severe Post-capillary Pulmonary Hypertension Caused by COPD
Official title: The Safety and Efficiency of Sildenafil in the Treatment of Severe Post-capillary Pulmonary Hypertension Caused by COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Pulmonary Hypertension
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 23 patients use placebo and 23 patients use sidenafil for 12 weeks' treatment
Primary purpose: TREATMENT

Brief summary: Over half of chronic obstructive pulmonary disease (COPD) patients develop pulmonary hypertension. The current therapy focuses only on the basic disease and there are a lot of controversies about the use of PAH target therapy in group 3 pulmonary hypertension. Our study is to explore whether sildenafil, a pulmonary arterial hypertension (PAH) target drug, could be efficient and safe in improving symptoms and survival of severe pulmonary hypertension caused by COPD.


Eligibility criteria: Inclusion Criteria:

* Stable for over 1 month
* mean pulmonary artery pressure ≥35mmHg, pulmonary wedge pressure≤ 15mmHg
* never received target therapy before

Exclusion Criteria:

* Patients with other serious respiratory diseases
* Patients with pulmonary hypertension other than group 3
* Patients with right heart hypertrophy or dysfunction not caused by chronic obstructive pulmonary diseases
* Patients with limited life expectancy
* Patients with history of tracheal intubation or stoke, acute coronary syndrome in 6 months
* Psychopath or addict
* Nonstable patients with type Ⅰor Ⅱ respiratory failure
* Patients with contraindication for sildenafil
* Patients in pregnancy or breastfeeding

Primary outcomes:
measure: pulmonary artery pressure
timeFrame: 12 weeks
measure: pulmonary vascular resistance
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT06110364: Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions
Official title: Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Premature Ventricular Contraction
Keywords: NIVNS Non-invasive vagal nerve stimulation
LLTS- Low-level tragus stimulation
HRV-BF - Heart rate variability biofeedback
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor class: FED
Collaborators: name: Virginia Commonwealth University
First posted: 2023-10-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will be randomized to Premature ventricular contraction suppression strategies: 1) Lower level tragus stimulation 2) Heart rate variability biofeedback and 3) conventional medical therapy (usual care)
Primary purpose: TREATMENT

Brief summary: Prospective randomized control pilot study

Detailed description: The primary aims of this investigator initiated study is :

Aim 1: to assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions and Aim 2: to compare the efficacy of Lower-level Tragus stimulation and Heart rate variability- Biofeedback in suppression of Premature Ventricular Contractions.

Eligibility criteria: Inclusion Criteria:

* Normal Left Ventricular systolic function
* Frequent PVCs

Exclusion Criteria:

* Current use of any (I and/or III) antiarrhythmic medication
* Contraindication to use beta blockers and non-dihydropyridine calcium channel blockers
* Complete Atrioventricular block and pacemaker dependent
* Ongoing uncontrolled hypertension with systolic Blood Pressure\> 180
* Family history of dilated Cardiomyopathy in a first degree relative
* Alcohol use disorder or illicit drug use
* Actively being treated Atrial fibrillation/ Flutter with Rapid Ventricular Response
* Moderate to severe valve disorders
* Patient with shortwave/microwave therapy equipment

Primary outcomes:
measure: Assess the ability of non-invasive vagal nerve stimulation to suppress Premature Ventricular Contractions.
timeFrame: perspective 12-week study (each arm lasting two weeks with a one week washout between each arm)
Secondary outcomes:
measure: Compare the efficacy of non-invasive vagal nerve stimulation via lower-level vagal stimulation and heart rate variability in suppression of Premature Ventricular Contractions.
timeFrame: perspective 12-week study (each arm lasting two weeks with a one-week washout between each arm)
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Richmond VA Medical Center
state: Virginia
Study officials:
affiliation: Hunter Holmes McGuire Veterans Medical Center
name: Jose Huizar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00543764: Intraoperative Pathway in DIEP Flap Breast Reconstruction
Official title: Intraoperative Pathway in DIEP Flap Breast Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Intraoperative Pathway
Breast Reconstruction
DIEP flap
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2007-10-15
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing breast reconstruction

Brief summary: Efficiency in the operating room can be difficult in long cases with multiple surgeons. We used a team based approach to develop an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.

Detailed description: A team based approach was developed with an intraoperative pathway for microsurgical breast reconstruction with a deep inferior epigastric perforator flap.

Eligibility criteria: Inclusion Criteria:

* All cases prior to pathway

Exclusion Criteria:

* None

Primary outcomes:
measure: Operative Time
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Bernard T Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04634864: Transcranial Direct Current Stimulation in Post-stroke Fatigue
Official title: tDCS in Post-stroke Fatigue: a Double Blind, Sham-controlled, Bilateral Anodal Motor Cortical Stimulation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Stroke
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 33
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: This is a double-blind, sham-controlled, anodal tDCS study to understand the effect of increasing motor cortex excitability on post-stroke fatigue.


Eligibility criteria: Inclusion Criteria:

Diagnosed with stroke at least 3 months post-stroke

Exclusion Criteria:

Other neurological conditions on Anti-depressants severe motor impairment (affected hand grip \<60% unaffected hand) severe cognitive impairment (unable to follow instructions, or give informed consent) scored \>11 in the depression sub-section of HADS questionnaire contraindications for TMS or tES

Primary outcomes:
measure: Fatigue Severity Scale - 7
timeFrame: 2 weeks
Secondary outcomes:
measure: Resting Motor Threshold
timeFrame: 1 day
measure: Input-output curves
timeFrame: 1 day
measure: Perceived effort - Explicit
timeFrame: 1 day
measure: Perceived effort - Implicit
timeFrame: 1 day
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: 33 Queen Square, Institute of Neurology, UCL
Study officials:
References:
citation: De Doncker W, Ondobaka S, Kuppuswamy A. Effect of transcranial direct current stimulation on post-stroke fatigue. J Neurol. 2021 Aug;268(8):2831-2842. doi: 10.1007/s00415-021-10442-8. Epub 2021 Feb 17.
Clinical trial NCT04122664: Posterior Capsular Opacification and Glistenings in Hydrophobic and Hydrophilic Intraocular Lenses
Official title: Prospective Randomized Controlled Study Measuring Posterior Capsular Opacification, Lens Glistenings, Tilt and Decentration, and Visual Outcomes Following Insertion of the RayOne Hydrophobic Lens 800C and the RayOne Hydrophilic Lens 600C.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Intraocular Lens Opacification
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: City, University of London
name: King's College London
First posted: 2019-10-10
Enrollment: 176
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: TREATMENT

Brief summary: A prospective randomized controlled clinical study to measure posterior capsular opacification, objective measurement of glistenings and intraocular lens tilt and decentration as well as visual outcomes following insertion of a monofocal, aspheric, hydrophobic acrylic intraocular lens: the RayOne® Hydrophobic lens 800C and a monofocal aspheric, hydrophilic acrylic intraocular lens: the RayOne® Hydrophilic lens 600C


Eligibility criteria: Inclusion Criteria:

1. Unilateral or bilateral cataracts requiring surgical intervention
2. Age over 18 years
3. Able to understand informed consent and the objectives of the trial
4. Not pregnant, not breast feeding
5. No previous eye surgery
6. Corneal astigmatism less than 1 diopter in both eyes.

Exclusion Criteria:

1. age-related macula degeneration
2. glaucoma
3. previous retinal vascular disorders
4. previous retinal detachment or tear
5. any neuro-ophthalmological condition
6. any inherited retinal disorder or pathology
7. previous strabismus surgery or record of amblyopia
8. previous TIA, CVA or other vaso-occlusive disease
9. already enrolled in another study

Primary outcomes:
measure: Posterior Capsular Opacification of Intraocular Lens
timeFrame: 24 months
measure: Intraocular lens glistenings
timeFrame: 24 months
measure: Intraocular lens tilt and decentration
timeFrame: 24 months
Secondary outcomes:
measure: Visual Acuities
timeFrame: 24 months
measure: Forward light scatter and Contrast Sensitivity Measurement
timeFrame: 24 months
measure: Patient Satisfaction
timeFrame: 24 months
measure: Intraoperative and post operative complications
timeFrame: 0 days-24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02881164: Glycemic Index in Subjects With Diabetes Mellitus Insulin Requesting
Official title: Effect of Glycemic Index of a Preparation on Postprandial Metabolic Parameters and Satiety in Subjects With Type 2 Diabetes Mellitus Under Intensive Insulin Therapy: Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Glycemia
Satiety
Insulin
Breakfast
Low glycemic index
High glycemic index
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 10
Sex: ALL
Minimum age (years): 47
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the acute effect of a low and high glycemic index breakfast on the glycemic response and satiety in subjects with type 2 diabetes mellitus under intensive insulin therapy.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes mellitus diagnosis.
* Minimum period of six months under intensive insulin therapy.
* Fast insulin prescription before breakfast.
* 35 and 70 years of age.
* BMI between 25 and 39.9 Kg/m2.
* HbA1c less than or equal to 10 % (86mmol/mol)
* Menopausal women under hormone replacement therapy

Exclusion Criteria:

* Pregnant women.
* Puerperal women.
* Subjects with neurological disease, endocrine disorder no treatment, kidney disease in stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, human immunodeficiency virus.
* Subjects with history of stroke, acute myocardial infarction or gastrointestinal resection.

Primary outcomes:
measure: Glycemia
timeFrame: -15 up to 120 minutes
measure: Satiety
timeFrame: Up to 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lobos DR, Vicuna IA, Novik V, Vega CA. Effect of high and low glycemic index breakfast on postprandial metabolic parameters and satiety in subjects with type 2 diabetes mellitus under intensive insulin therapy: Controlled clinical trial. Clin Nutr ESPEN. 2017 Aug;20:12-16. doi: 10.1016/j.clnesp.2017.04.082. Epub 2017 May 11.
Clinical trial NCT00473564: Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery
Official title: Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Oropharyngeal Cancer
Hypopharyngeal Cancer
Upper Aerodigestive Tract Neoplasms
Keywords: Lesions
Biopsy
Surgery
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2007-05-15
Enrollment: 170
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time.

Detailed description: This trial is a single institution non-randomized study to evaluate the efficacy and safety of the da Vinci® Robotic Surgical System. This study will evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time. This is a robotic system used by surgeons to perform surgery in a less invasive manner.

Eligibility criteria: Inclusion Criteria:

* Head and neck lesions requiring surgical resection, biopsy, or invasive treatment;
* Lesion amendable to robotic assisted surgery treatment;
* Age \> 19 years;
* Patient must sign informed consent.

Exclusion Criteria:

* Psychological condition that renders the patient unable to understand the informed consent;
* Poor mouth opening, with maximal opening less than 1.5 cm.

Primary outcomes:
measure: Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions
timeFrame: Intraoperatively average of 2 hours
Secondary outcomes:
measure: Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.
timeFrame: 3 - 24 months postoperatively
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Medical Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: William Carroll, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dean NR, Rosenthal EL, Carroll WR, Kostrzewa JP, Jones VL, Desmond RA, Clemons L, Magnuson JS. Robotic-assisted surgery for primary or recurrent oropharyngeal carcinoma. Arch Otolaryngol Head Neck Surg. 2010 Apr;136(4):380-4. doi: 10.1001/archoto.2010.40.
citation: Iseli TA, Kulbersh BD, Iseli CE, Carroll WR, Rosenthal EL, Magnuson JS. Functional outcomes after transoral robotic surgery for head and neck cancer. Otolaryngol Head Neck Surg. 2009 Aug;141(2):166-71. doi: 10.1016/j.otohns.2009.05.014.
citation: Boudreaux BA, Rosenthal EL, Magnuson JS, Newman JR, Desmond RA, Clemons L, Carroll WR. Robot-assisted surgery for upper aerodigestive tract neoplasms. Arch Otolaryngol Head Neck Surg. 2009 Apr;135(4):397-401. doi: 10.1001/archoto.2009.24.
Clinical trial NCT05747664: To Compare the Safety and PK/PD Characteristics of Subjects With Between Hepatic Impairment and Normal Hepatic Function
Official title: An Open-label, Multi-center, Parallel, Single Oral Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of DWP16001 in Subjects With Hepatic Impairment Compared With Subjects With Normal Hepatic Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-02-28
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of DWP16001 in subjects with hepatic impairment compared with subjects with normal hepatic function.

Detailed description: The study design is An open-label, multi-center, parallel, single oral dose study.

Eligibility criteria: Inclusion Criteria:

1. A person who has decided to participate voluntarily and agreed in writing prior to the screening procedure after understanding the detailed explanation of this clinical trial.
2. A person who is 19 years of age or more and under 80 years of age at the time of screening.
3. Those with a weight of 45.0 kg or more and 90.0 kg or less and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.

Exclusion Criteria:

1. A person who has a history of gastrointestinal diseases (e.g., ulcer, inflammatory bowel disease, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of DWP16001.
2. Those who are hypersensitive to drugs and other drugs (aspirin, antibiotics, etc.) including the SGLT2 inhibitor family or who have a history of clinically significant hypersensitivity reaction.
3. Serum Cr \>1.5mg/dL or eGFR (CKD-EPI Cr) \<60mL/min/1.73m2
4. Those who have used SGLT2 inhibitor family drugs within two weeks of the scheduled date of administration of DWP16001.

Primary outcomes:
measure: Cmax of DWP16001
timeFrame: 0 to 48 hours
measure: AUClast of DWP16001
timeFrame: 0 to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: