louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05449600: Thermotape High-adhesion Medical Tape Comparison Study
Official title: Thermotape High-adhesion Medical Tape Comparison Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Injury
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: University of Washington Institute for Translational Health Science (UL1 TR002319)
First posted: 2022-07-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Tegaderm™ tape, Kind™ tape, and Thermotape will be applied to both forearms for 24 hours. Afterwards, one forearm will have the tapes removed normally, without any intervention. The other forearm will have the tapes removed after heat is applied, using a heatpack.
Primary purpose: OTHER

Brief summary: This objective of this study is to compare the safety and performance of Thermotape compared to Tegaderm™ tape and Kind™ tape over the course of 24 hours.


Eligibility criteria: Inclusion Criteria:

* Participants should be between 18 to 25 years of age.

Exclusion Criteria:

* Participants with history of eczema or medical related skin injuries (MARSI), allergic to adhesives, and/or have a wound or rash on their skin will be excluded.

Primary outcomes:
measure: Pain Experienced by Tape Removal
timeFrame: Each removal and assessment would take at maximum 5 minutes.
measure: Skin Irritation
timeFrame: Subjects will wait approximately 15 minutes before leaving, to ensure that irritation has occurred.
Secondary outcomes:
measure: Skin cells
timeFrame: The removal of each tape will take a maximum of 2 minutes.
measure: Wear
timeFrame: The removal of each tape will take a maximum of 2 minutes.
measure: Hair Follicles
timeFrame: The removal of each tape will take a maximum of 2 minutes.
measure: Trans-epidermal Water Loss
timeFrame: The removal of each tape will take a maximum of 2 minutes.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Eric J Seibel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01372800: Serum Adiponectin in Chinese Population and Its Correlation to Cardiovascular and Cerebrovascular Diseases
Official title: Serum Adiponectin Concentration, Activity and Isoforms in Chinese Population and Its Correlation to Cardiovascular and Cerebrovascular Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction
Cerebral Infarction
Keywords: adiponectin
cardiovascular diseases
cerebrovascular diseases
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2011-06-14
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: volunteer

Brief summary: Adiponectin (Ad) is an abundant protein in human body, and reports have shown that it act as a novel risk factor for brain and heart ischemia injury. This 5 years follow-up study will focus on serum adiponectin concentration, activity and isoforms in Chinese population and its correlation to these diseases.

Detailed description: Adiponectin (Ad) is an abundant protein hormone regulatory of numerous metabolic processes, anti-inflammatory, vascular protective, and anti-ischemic properties. Since its 1995 discovery, Ad has garnered considerable attention for its role in diabetic and cardiovascular pathology. Clinical observations have demonstrated the association of hypoadiponectinemia in patients with obesity, cardiovascular disease, and insulin resistance. There is growing evidence supporting Ad can act as a novel risk factor for cardiovascular and cerebrovascular injury. This 5 years follow-up study will focus on serum adiponectin concentration, activity and isoforms in Chinese population and its correlation to cardiovascular and cerebrovascular diseases.

Eligibility criteria: Inclusion Criteria:

* available for 5 years of follow-up study

Exclusion Criteria:

* Death caused other than cardiovascular and cerebralvascular diseases till the study ends
* Floating Population
* Pregnancy, lactation, or child bearing women
* Tumor
* Active hepatic disease or hepatic dysfunction, or AST/ALT \> 1.5UNL
* Severe renal dysfunction(Scr \> 3 mg/dl or 264μmol/L)
* Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding

Primary outcomes:
measure: Number of Participants with major adverse events
timeFrame: 5 years
Secondary outcomes:
measure: blood routine, glucose and lipid profile; ECG;
timeFrame: 5 years
measure: serum adiponectin concentration, activity and isoforms
timeFrame: 5 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References:
citation: Gao C, Zhao S, Lian K, Mi B, Si R, Tan Z, Fu F, Wang S, Wang R, Ma X, Tao L. C1q/TNF-related protein 3 (CTRP3) and 9 (CTRP9) concentrations are decreased in patients with heart failure and are associated with increased morbidity and mortality. BMC Cardiovasc Disord. 2019 Jun 10;19(1):139. doi: 10.1186/s12872-019-1117-0.
Clinical trial NCT06685900: Efficacy and Safety of Symptom Improvement by Digital Therapeutics to Manage Hypotension Symptoms
Official title: A Single-center, Randomized Controlled Pilot Trial to Evaluate Efficacy and Safety of Symptom Improvement by Digital Therapeutics to Manage Hypotension Symptoms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypotension
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial is an exploratory study aimed at assessing the efficacy and safety of a digital therapeutic for managing symptoms of hypotension, with the goal of providing evidence for the design of future confirmatory clinical research.


Eligibility criteria: Inclusion Criteria:

1. Adults aged 19 and older with symptoms suspected to be related to dizziness due to hypotension within the past year.
2. Individuals who are able to walk and can participate in the study using a smartphone, or for whom cooperation from a guardian is available.

Exclusion Criteria:

1. Individuals diagnosed with causes of dizziness other than hypotension, such as benign paroxysmal positional vertigo or stroke, within the past year.
2. Severe anemia (history of Hb \< 8.0 g/dL within the last 3 months).
3. Individuals unable to use a smartphone (Android phone) or smartwatch.
4. Individuals with a life expectancy of less than 1 year due to diseases such as malignant tumors.
5. Individuals diagnosed with severe heart valve disease or severe heart failure with LVEF \< 35% (based on the most recent examination).
6. Recent rapid and unintended weight loss (5% or more, or 5 kg or more, within the last 6 months).

Primary outcomes:
measure: The number of hypotension symptom events
timeFrame: within the first 6weeks after intervention
Secondary outcomes:
measure: Number of symptoms related to hypotension
timeFrame: over 15weeks
measure: Number of falling accident
timeFrame: over 15weeks
measure: Details for disease diagnosis and concomitant medications
timeFrame: over 15weeks
measure: The frequency of use of digital therapeutics
timeFrame: at 15weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei university college of medicine
Study officials:
References:
Clinical trial NCT00820300: A Safety Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open Angle Glaucoma
Official title: An Open-Label, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Mati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the Punctal Plug Delivery System is safe and effective in controlling intraocular pressure in patients with ocular hypertension or open-angle glaucoma.


Eligibility criteria: Inclusion Criteria:

* Over 18 yrs with ocular hypertension or open-angle glaucoma
* Subjects who have a best-corrected visual acuity of 20/100 or better.

Exclusion Criteria:

* Subjects who wear contact lenses.
* Uncontrolled medical conditions
* Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
* Subjects who have a history of chronic or recurrent inflammatory eye disease.

Primary outcomes:
measure: IOP change from baseline
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Menlo Park
country: United States
state: California
Study officials:
affiliation: QLT Inc.
name: Oscar Cuzzani, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00479700: Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Subjects
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety and tolerability of ascending single oral doses of SAM-531 in healthy subjects.To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-531, an investigational drug, in healthy subjects and to evaluate the effect of a high-fat meal on the PK of SAM-531 administered to healthy subjects.


Eligibility criteria: Inclusion criteria

1. Men or women of nonchildbearing potential aged 18 to 45 years
2. Elderly men or women aged 65 years and above as of study day 1.
3. Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. Body weight for elderly subjects must be ≥45 kg.

Exclusion criteria

1. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease
2. Any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ECGs, or clinical laboratory test results.
3. Tobacco use or the consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1, or grapefruit or grapefruit-containing products 72 hours before study day 1, and until the end of the inpatient confinement period.

Primary outcomes:
measure: Safety and tolerability
Secondary outcomes:
measure: Pharmacokinetics and pharmacodynamics
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01669200: Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment
Official title: Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 4
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to assess whether daily dosing with medium chain triglycerides in subjects with mild cognitive impairment (MCI) will improve cognitive performance.

Detailed description: Twenty eligible subjects will be enrolled in the study that will consist of a baseline visit followed by six post-baseline visits. The control and placebo groups will each be comprised of ten subjects randomly assigned to the groups. The assessments at baseline will include concomitant medications, vital signs, height, and weight. In addition, subjects will complete a medical history questionnaire, and receive group instruction on incorporation of the study products into the diet from a registered dietitian. Study products will be dispensed at each visit in excess of requirements, and re-issued at every visit after measurement of the remaining product that subjects will be instructed to bring to every visit. The post-baseline study visits will include body weight and vital sign measurements, concomitant medications, dispensation of study products, group instruction by a registered dietitian, and an assessment for adverse events.

Between study visits the subjects will receive a telephone call from the study coordinator to encourage compliance with the diet, and to ask about any adverse events. The study visits will conclude at week 24. The psychological tests conducted by clinicians at screening will be repeated during the cognitive testing visit.

Eligibility criteria: Inclusion Criteria:

1. Are male or female with a diagnosis of Mild Cognitive Impairment
2. Are 50 years of age or older

Exclusion Criteria:

1. Been on medication for Mild Cognitive Impairment less than 90 days
2. Major depression
3. Uncontrolled hypothyroidism
4. Known B12 deficiency
5. Hepatic (liver) disease or insufficiency

Primary outcomes:
measure: Improvement in cognitive performance
timeFrame: Assess in subjects at Baseline to week 24 using different Cognitive testing scores.
Secondary outcomes:
measure: Serum Ketones
timeFrame: Baselines to 6 months
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT00804700: Impact of Two Methods of Listening to Music During Exercise on Perceived Exertion and Overall Physical Activity
Official title: Impact of Two Methods of Listening to Music During Exercise on Perceived Exertion and Overall Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: synchronous
exercise
music
heartbeat
tunes
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to compare two different methods of listening to music while performing aerobic exercise: synchronous music listening vs. asynchronous music listening. Synchronous music listening while exercising is a learned activity where the participant moves his or her body in synchrony with the beat of the music, similar to dancing or to participating in a group exercise (aerobics) class. Our hypothesis is that synchronous music listening reduces the level of perceived exertion to the exercise and motivates the subject to exercise more often. This study randomly assigns 46 subjects, age 20-55 years old to either a control group of listening to their own favorite music in an asynchronous fashion or to an intervention group of listening to prepared music in a synchronous fashion over a six week period.


Eligibility criteria: Inclusion Criteria:

* Adult employees of Georgetown University (age 20-55) who listen to music while exercising.

Exclusion Criteria::

* A major medical condition that would prevent the participant from undertaking regular exercise
* The use of beta blocker medication
* Participation in varsity sports

Primary outcomes:
measure: Change in Borg Rating of Perceived Exertion (RPE) from baseline to final test at 6 weeks intervention
timeFrame: 6 weeks
Secondary outcomes:
measure: Difference in exercise-related energy expenditure over six weeks between to intervention and control groups
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Washington DC
country: United States
facility: Georgetown University
state: District of Columbia
Study officials:
References:
Clinical trial NCT05590000: Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System
Official title: Study of Gemini Rechargeable Spinal Cord Stimulation System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Gemini rechargeable SCS System
ABT-CIP-10407
IPG
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2022-10-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this pre-market, prospective, single-arm, non-randomized, open-label, multi-center clinical study is to collect confirmatory data to show that the Gemini SCS neurostimulation system functions as intended in a clinical setting.


Eligibility criteria: Inclusion Criteria:

1. Subject is indicated for an SCS system, or has an implanted SCS system and is scheduled to receive an IPG replacement.
2. Subject is scheduled to receive a new IPG permanent implant and has completed a successful SCS trial in the last 6-months, OR subject is scheduled to undergo an all-in-one procedure OR has an implanted SCS system for an approved chronic pain indication.
3. Subject has a documented NRS pain score of ≥ 6 after at least 5 days without stimulation OR has an implanted functioning SCS system with NRS pain score of ≤ 4.
4. Subject must provide written informed consent prior to any clinical investigation-related procedure.
5. Subject is at least 18 years at the time of enrollment.
6. Subject is capable and willing to recharge an implanted IPG.

Exclusion Criteria:

1. Subject's SCS trial was unsuccessful.
2. Subject is currently participating, or intends to participate, in another clinical investigation that may confound the results of this study, as determined by Abbott.
3. Subject has or will receive more than one IPG.
4. Subject is pregnant or breastfeeding or plans to become pregnant during the clinical investigation follow-up period.
5. Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's assessment, could limit the subject's ability to participate in the clinical investigation.
6. Subject has or is scheduled to receive an intrathecal pump.
7. Subject is part of a vulnerable population.

Primary outcomes:
measure: Confirmatory Safety Endpoint: The Rate of Serious Adverse Events Related to the Investigational IPG and/or Charging System
timeFrame: At 6 weeks (30-45 days) follow-up post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Auchenflower
country: Australia
facility: QPain
city: Clayton
country: Australia
facility: Metro Pain Group
city: Hurstville
country: Australia
facility: Sydney Spine & Pain
city: Parramatta
country: Australia
facility: Sydney Pain Management Centre
city: Perth
country: Australia
facility: Pain Care Perth
city: Wayville
country: Australia
facility: PainMedSA-Pain & Rehabilitation Specialists
Study officials:
References:
Clinical trial NCT00416000: Mechanism and Prevention of Remote Organ Injury Following Ruptured Aortic Aneurysm
Official title: Phase 1 Study of Complement Activation Following Ruptured Abdominal Aortic Aneurysm: Combining Human Observation With Animal Experimentation to Establish a Framework for Human Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Keywords: Open/Elective EVAR patients
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2006-12-27
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those undergoing AAA repair for elevtive and ruptured AAA by both EVAR and open methods.

Brief summary: It has been estimated that 80% of deaths from abdominal aortic aneurysms results from rupture. Endovascular Aneurysm Repair (EVAR) has been applied to RAAA (Ruptured Abdominal Aortic Aneurysm) patients with reports of improvements. Despite the use of EVAR, patients have developed complications with lung and kidney function. This study will investigate certain biochemical processes that will potentially reduce these complications. Knowledge gained from this study may also be used to further research in this field through larger studies.


Eligibility criteria: Inclusion Criteria:

* Open/Elective EVAR patients

Exclusion Criteria:

* Patients who do not present with abdominal aortic aneurysms or ruptured abdominal aortic aneurysm

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: multiple organ failure
timeFrame: 30 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: TGH, UHN
name: Thomas F Lindsay, MD
role: PRINCIPAL_INVESTIGATOR
References: