louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03001206: The Use of the Master Caution System (MCS) for Continuous Monitoring and Detection of Dysrhythmias and Ischemic Events
Official title: The Use of Master Caution System for Continuous Monitoring and Detection of Dysrhythmia and Ischemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: HealthWatch Ltd.
Sponsor class: INDUSTRY
First posted: 2016-12-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible subjects admitted and diagnosed as acute coronary syndrome, before or after catheterization, who need to be monitored for evaluation of treatment efficacy.

Eligible subjects referred to stress imaging test, with current or previously depicted STT changes.

Brief summary: The purpose of this study is to evaluate the effectiveness and usability of the Master Caution System for 12 leads continuous monitoring of ECG signal in the ICCU.

The purpose of the study is to evaluate the effectiveness and usability of using Master Caution 12 leads Garment for stress test.

The purpose of the study is to reassess the adequate size of the Master Caution Garment.


Eligibility criteria: Inclusion Criteria:

* Age\>18 years.
* Diagnosed or have evidence of ACS, or referred for stress imaging due to suspected ischemia with STT changes.
* Needs continuous/routine ECG monitoring.
* Ability to give informed consent.
* Cooperative person

Exclusion Criteria:

* Patients with known allergy to silver.
* Patients with dermal disease or recent trauma to the chest wall.
* Pregnant or lactating woman.
* Patients with chest deformity precluding placement of the garment.
* Patients suffering from tremor.
* Patients participating in another ongoing trial.

Primary outcomes:
measure: Measuring 12 leads ECG information of patients at the ICCU in continuous monitoring using Master Caution System (MCS) will give more cardiac information comparing to regular hospital 2-3 leads telemetry.
timeFrame: 48 hours
measure: Measuring 12 leads ECG information of patients at the stress test using Master Caution System (MCS) comparing to the standard of care stress test ECG device and Electrodes.
timeFrame: 1-2 hours
Secondary outcomes:
measure: Master Caution System (MCS) cardiac telemetry system will measure and provide sufficient ECG information for adequate detection and interpretation of ST-T wave changes and dysrhythmic events.
timeFrame: during the use of the system
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Morris Mosseri, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06058806: Effects of Multimodal Physical Therapy in Patients With Lumbosacral Radiculopathy
Official title: Effects of Multimodal Physical Therapy on Pain, Disability, H-reflex, and Diffusion Tensor Imaging Parameters in Patients With Lumbosacral Radiculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbosacral Radiculopathy
Keywords: Lumbosacral Radiculopathy
Lumbar disc herniation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purposes of the study

To investigate the effect of Multimodal Physical Therapy on pain, daiablility H-reflex, and Diffusion Tensor Imaging (DTI) Parameters in Patients With Lumbosacral Radiculopathy.

Detailed description: Participants will receive Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises. Patients will receive the intervention for six weeks. Outcomes will be assessed at baseline and post-intervention.

Eligibility criteria: Inclusion Criteria:

* chronic (≥ 3 months) unilateral Lumbosacral Radiculopathy (LSR)
* The LSR is due to paracentral L4-L5 or L5-S1 Lumbar disc herniation
* The LSR is confirmed radiologically by MRI
* The LSR is confirmed clinically by history and physical examination
* The LSR is confirmed neurophysiological by soleus H-reflex assessment
* Body mass Index less than 30
* 20-45 years of age

Exclusion Criteria:

* systematic disease
* Bilateral symptoms
* Lumbar spinal stenosis
* previous surgery
* Steroid injection
* Spinal fracture
* Lumbar spinal stenosis
* Spinal deformity
* Spinal fracture
* Radiological evidence of bilateral nerve root encroachmen
* Evidence of H-reflex amplitude or latency affection on asymptomatic side

Primary outcomes:
measure: Pain
timeFrame: Change from Baseline pain at 6 weaks
measure: Disability
timeFrame: Change from Baseline Disability at 6 weaks
measure: Soleus H-reflex amplitude
timeFrame: Change from Baseline Soleus H-reflex amplitude at 6 weaks
measure: Soleus H-reflex side-to-side amplitude (H/H) ratio
timeFrame: Change from Baseline Soleus H/H ratio at 6 weaks
measure: Fractional anisotropy (FA) of the compressed nerve root
timeFrame: Change from Baseline Fractional anisotropy (FA) ratio at 6 weaks
measure: Apparent diffusion coefficient (ADC) of the compressed nerve root
timeFrame: Change from Baseline Apparent diffusion coefficient (ADC) at 6 weaks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Outpatient clinic, Faculty of Physical Therapy, Cairo University
Study officials:
References:
Clinical trial NCT00871806: Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With Water
Official title: Phase 1, Open-Label, Randomized, Single-Dose, 5-Way Crossover Pilot Bioavailability Study Comparing Eletriptan Oral Disintegrating Tablet Formulations A And B Administered With Or Without Water To Relpax® Commercial Tablets Administered With Water
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics
eletriptan
bioavailability
oral disintegrating tablet
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-30
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study will evaluate whether the blood concentrations of eletriptan administered using two test formulations of oral disintegrating tablets are comparable to those observed with the standard commercial tablet.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* No CYP3A4 inhibitors

Exclusion Criteria:

* Clinically significant disease in any organ system
* Positive urine drug screen

Primary outcomes:
measure: Eletriptan area under the concentration time curve (AUC) and peak concentration (Cmax)
timeFrame: 24 hr
Secondary outcomes:
measure: Time of peak eletriptan concentrations (Tmax), half life
timeFrame: 24 hr
measure: Tolerability and safety of treatments assessed by adverse events, vital signs, clinical lab tests
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01811706: Dalfampridine and Gait in Spinocerebellar Ataxias
Official title: Therapeutic Effect of Dalfampridine on Gait Incoordination in Spinocerebellar Ataxias- A Randomized, Double-blinded, Placebo-controlled, Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinocerebellar Ataxias Type 1
Spinocerebellar Ataxias Type 2
Spinocerebellar Ataxias Type 3
Spinocerebellar Ataxias Type 6
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Acorda Therapeutics
First posted: 2013-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Investigators expect there will be improvement in walking speed and steadiness after taking Dalfampridine, thereby improving activities of daily living and enhancing social and occupational functions for patients with spinocerebellar ataxia.

Detailed description: Twenty spinocerebellar ataxia patients will be randomized to receive either Dalfampridine or placebo over a total period of 10 weeks. After entering the study, patients will return every 2 weeks for evaluation. After four weeks, intervention will be stopped and patient will enter a 2-week wash out period where they do not take any drug. Then, patients will be given the opposite treatment (Dalfampridine or placebo) and this "crossover" study will be performed for another 4 weeks. Investigators expect there will be improvement in walking speed and steadiness after taking Dalfampridine, thereby improving activities of daily living and enhancing social and occupational functions.

Eligibility criteria: Inclusion Criteria:

* Individuals at age 18 years or older.
* Individuals who can provide the informed consent
* Genetic confirmed definite spinocerebellar ataxias (SCA)
* Able to complete two trials of the timed 25-foot walk at screening

Exclusion Criteria:

* Patients who has severe ataxia and unable to ambulate.
* Any orthopedic condition that would affect motor performance.
* Patients with secondary ataxia from general medical disorders
* Individuals who have major psychiatric disorders that prevents compliance
* History of epilepsy
* Patients with active drug or alcohol use or dependence that would interfere with adherence to study requirements
* Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Primary outcomes:
measure: Change in Timed 25 Feet Walking Test (T25FW)
timeFrame: Baseline and 4 weeks after Dalfampridine or placebo
Secondary outcomes:
measure: Change in Scale of Assessment and Rating of Ataxia (SARA)
timeFrame: Baseline and 4 weeks after Dalfampridine or placebo
measure: Biomechanical Assessment of Gait (BAG)-Stride Length
timeFrame: Baseline and 4 weeks after Dalfampridine or placebo
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Guangbin Xia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06941506: Using SPOZ Technology to Support and Enhance the Vitality Acupunch (VA) Exercise Program for Older Adults With Dementia
Official title: The Integration of SPOZ Technology to Support and Enhance the Vitality Acupunch Exercise Program for Improving the Cognitive Behavioral Impairment and Sensory Perceptual Impairment of Older Adults With Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive and Behavioral Impairment
Sensory and Perceptual Impairment
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 122
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project aims to examine the effects of a six-month VA exercise program incorporate the SPOZ technology in improving the cognitive behavioral impairment and sensory perceptual impairment of older adults with dementia in adult daycare centers.

Detailed description: A cluster-randomized controlled trial will be conducted to examine the effects of a six-month VA exercise program incorporate the SPOZ technology in improving the cognitive behavioral impairment (using Montreal Cognitive Assessment and Neuropsychiatric Inventory Questionnaire) and sensory perceptual impairment (using Pain Assessment in Advanced Dementia) of older adults with dementia in adult daycare centers. Using convenience sampling, 10 adult daycare centers with 122 older adults will be recruited, and then cluster-randomized by the daycare centers to an experimental or a control group. The experimental group will receive a 40-minute program 3 times a week for 6 months; the control group will maintain their routine activities. The two groups will be measured at three time points: before the intervention, and at three months and six months of the intervention.

Eligibility criteria: Inclusion Criteria:

* diagnosed as dementia by a physician, or
* screened by the SPMSQ as dementia
* age 65 and older

Exclusion Criteria:

* have severe cardiopulmonary disease
* have physical mobility impairment
* have spinal cord injury

Primary outcomes:
measure: Cognitive status
timeFrame: 6 months
Secondary outcomes:
measure: Behavioral and psychological symptoms of dementia (BPSD)
timeFrame: 6 months
measure: Pain status
timeFrame: 6 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
affiliation: Kaohsiung Medical University
name: Kuei-Min Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00805506: Evaluation of Glucose Monitoring Methods: Characterizing Glycemic Control in Subjects With Diabetes
Official title: Evaluation of Glucose Monitoring Methods: Characterizing Glycemic Control in Subjects With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: continuous glucose monitoring accuracy
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: International Diabetes Center at Park Nicollet
name: LifeScan
First posted: 2008-12-09
Enrollment: 16
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: adults with diabetes who are treated with insulin

Brief summary: Evaluate the usefulness of continuous glucose monitoring devices in terms of their ability to identify periods throughout the day when glucose varies significantly.

Detailed description: Many CGM systems use a surrogate for blood glucose--tissue glucose or interstitial glucose. Interstitial fluid (ISF) is the medium for these approaches. A physiological lag in ISF glucose relative to capillary blood glucose has been noted, probably due to relatively low blood perfusion at the sampling site. 9 This physiological lag can result in an accuracy error, manifesting as a significant bias between blood and tissue glucose, particularly during periods of rapid glucose change. This lag error might be particularly meaningful when glucose is rapidly dropping towards hypoglycemia.

Eligibility criteria: Inclusion Criteria:

* adult
* A1c \>7.4 within last 4 months
* type 1 or 2 diabetes treated with basal/bolus insulin

Exclusion Criteria:

* under 18 years of age
* unable to read/write english
* allergy to adhesives
* employee of CGM company

Primary outcomes:
measure: To collect sufficient glucose data by means of continuous glucose monitoring for the purpose of detecting clinically relevant alterations in blood glucose throughout a typical or modal day.
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
Study officials:
affiliation: International Diabetes Center at Park Nicollet
name: Roger S Mazze, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center at Park Nicollet
name: Elinor (Ellie) S Strock, APRN BC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05705206: Feasibility and Accuracy of Core Temperature Measurements Using the Esophageal Temperature Probe Inserted Through the Gastric Lumen of Supraglottic Airway Device in Pediatrics
Official title: Feasibility and Accuracy of Core Temperature Measurements Using the Esophageal Temperature Probe Inserted Through the Gastric Lumen of Supraglottic Airway Device in Pediatrics: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temperature Change, Body
Supraglottic Airway Device
Pediatric ALL
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 42
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatrics patients under six years old patients undergoing general anesthesia using the Supraglottic airway device

Brief summary: In pediatric patients, the accuracy of body temperature measured with an esophageal temperature probe placed through the gastric lumen of the supraglottic airway device is investigated.

Detailed description: Pediatric patients using a supraglottic airway device during general anesthesia are targeted. When the patient enters the operating room, standard monitoring is performed, general anesthesia is induced, a supraglottic airway device is installed, and an anesthesiologist inserts an esophageal thermometer through the gastric lumen. We recorded the body temperature measured in the esophagus, tympanic membrane, temporal artery, and rectum every 10 minutes from 10 minutes after insertion.

Eligibility criteria: Inclusion Criteria:

* Pediatrics patients under six years old with ASA PS 1-3
* Patients undergoing general anesthesia using the Supraglottic airway device
* Patient's weight: 10-30kg

Exclusion Criteria:

* Patients who refused to participate in the study
* Patients with tumors in the esophagus or esophageal varices
* Patients with a monitoring device inserted through the esophagus during surgery
* Patients with ear inflammation
* Patients with congenital anomaly in the rectum
* Patients judged unfit to participate in the study by medical staff for other reasons

Primary outcomes:
measure: Comparison of esophageal temperature and temperature at tympanic membrane, rectum, temporal artery
timeFrame: 10min
Secondary outcomes:
measure: Effect of gastric suction through an esophageal temperature probe
timeFrame: After inserting the esophageal temperature probe
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT02468206: Secondary Prophylaxis of Gastric Variceal Bleed
Official title: Endoscopic Cyanoacrylate Injection vs. Balloon-occluded Retrograde Transvenous Obliteration in the Prevention of Gastric Variceal Rebleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Varices
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal rebleeding and improvement in survival.


Eligibility criteria: Inclusion Criteria:

1. Cirrhosis
2. Patients who had bled from GOV2 or IGV1（≥5 days and ≤ 28days）
3. Presence of gastrorenal shunt

Exclusion Criteria:

1. Previous treatment of gastric varices, including endoscopic therapy, NSBB, TIPS, or surgery
2. Non-cirrhotic portal hypertension
3. Contraindications to cyanoacrylate injection or BRTO
4. Portal cavernoma
5. Hepatorenal syndrome
6. Proven malignancy including hepatocellular carcinoma
7. End-stage renal disease under renal replacement therapy;
8. Cardiorespiratory failure
9. Pregnancy or patients not giving informed consent for endoscopic procedures

Primary outcomes:
measure: Rebleeding rate from gastric varices
timeFrame: 3 years
Secondary outcomes:
measure: Eradication rate of gastric varices
timeFrame: 3 years
measure: Number of participants with increase or decrease in the size of gastric varices
timeFrame: 3 years
measure: Number of participants with appearance or worsening of new oesophageal varices
timeFrame: 3 years
measure: Number of participants with appearance or worsening of portal hypertensive gastropathy
timeFrame: 3 years
measure: Number of participants with appearance or worsening of ascites
timeFrame: 3 years
measure: Number of participants with complication
timeFrame: 3 years
measure: Average in-hospital stay
timeFrame: 3 years
measure: Cost of treatment
timeFrame: 3 years
measure: Mortality rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT03467906: Role of Dietary Habits in Efficacy of Bariatric Surgery - Study B
Official title: Role of Dietary Habits in Efficacy of Bariatric Surgery - Study B
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bariatric Surgery
Sleeve Gastrectomy
Obesity
Keywords: Diet
Dietary Habits
Weight changes
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-03-16
Enrollment: 44
Sex: ALL
Minimum age (years): 22
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have undergone sleeve gastrectomy surgery.

Brief summary: The purpose of the study is to compare dietary habits after bariatric surgery in patients with poor weight loss versus good weight loss outcomes.

Detailed description: The obesity epidemic is a major public health concern with a significant economic burden in the USA. Bariatric surgery is the most effective and durable weight loss treatment, with long-term cardiometabolic health benefits. Among different types of bariatric procedures, sleeve gastrectomy (SG) has become the most commonly performed in USA. While SG is expected to result in a 50-60% excess weight loss, inter-individual differences in weight loss are large and approximately 25% of patients can be considered poor weight-loss responders who either do not lose a substantial amount of weight or regain the lost weight afterwards. The mechanisms underlying this clinical variation remain unknown and interventions to improve on these outcomes critically lacking. Of interest, altered daily dietary habits are experienced by a substantial proportion of bariatric surgery candidates, raising the question whether such alterations may contribute to inter-individual differences in weight loss success. Therefore, the purpose of the study is to compare dietary habits after bariatric surgery in patients with different weight loss outcomes.

Eligibility criteria: Inclusion Criteria:

* Bariatric surgery (sleeve gastrectomy) patients

Exclusion Criteria:

* Insulin-dependent diabetes
* Anemia
* Smoking
* Shift work within the past 1 year
* Drug or alcohol dependency
* Bipolar disorder
* Post traumatic stress disorder (PTSD)

Primary outcomes:
measure: Self-rated hunger
timeFrame: One day of laboratory protocol
Secondary outcomes:
measure: Self-rated appetite
timeFrame: One day of laboratory protocol
measure: Appetite-regulating hormones
timeFrame: One day of laboratory protocol
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Frank Scheer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Ali Tavakkoli, MD
role: PRINCIPAL_INVESTIGATOR
References: