louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01694368: Intracoronary Imaging With NIRS-IVUS to Characterize Arterial Plaques
Official title: Multimodality Advanced Intracoronary Imaging With Near-infrared Spectroscopy and Intravascular Ultrasound to Characterize Coronary Artery Plaques Before and After Percutaneous Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Near infrared spectroscopy; lipid core; vulnerable plaque
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Coronary Artery Disease Patients

Brief summary: To characterize atherosclerotic coronary artery plaques using advanced intra-coronary imaging with a combined near-infrared spectroscopy and intravascular ultrasound catheter before and after percutaneous intervention

Detailed description: This study is being performed to characterize the composition and morphologic characteristics of atherosclerotic coronary artery plaques with intra-coronary near-infrared spectroscopy and intravascular ultrasound in patients undergoing percutaneous coronary intervention.

Eligibility criteria: Inclusion Criteria:

1. Subject is at \> 18 years of age
2. Subject presents to the catheterization laboratory to undergo clinically-indicated, invasive coronary angiography
3. Subject is willing and able to provide informed written consent
4. Subject is found to have ≥ 1 severe coronary artery stenosis by invasive angiography and percutaneous coronary intervention is planned for definitive treatment or found to have ≥ 1 intermediate coronary artery stenosis and IVUS planned for lesion assessment
5. Coronary anatomy is deemed suitable for combined NIRS-IVUS by the interventional cardiologist performing invasive angiography and intervention

Exclusion Criteria:

1. Subject is pregnant or suspected to be pregnant
2. Subject is unable to provide informed consent
3. Subject has coronary artery anatomy deemed by interventionalist as unsuitable for NIRS-IVUS

Primary outcomes:
measure: MACCE
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health; Frederik Meijer Heart &Vascular Institute
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: Ryan D Madder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madder RD, Khan M, Husaini M, Chi M, Dionne S, VanOosterhout S, Borgman A, Collins JS, Jacoby M. Combined Near-Infrared Spectroscopy and Intravascular Ultrasound Imaging of Pre-Existing Coronary Artery Stents: Can Near-Infrared Spectroscopy Reliably Detect Neoatherosclerosis? Circ Cardiovasc Imaging. 2016 Jan;9(1):e003576. doi: 10.1161/CIRCIMAGING.115.003576.
Clinical trial NCT01910168: A Study to Collect Blood Samples From Patients With Spinal Muscular Atrophy for Biomarker Analysis
Official title: A Single Center Study to Collect Samples From SMA Patients for Biomarker Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscular Atrophy, Spinal
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: PTC Therapeutics
First posted: 2013-07-29
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with spinal muscular atrophy

Brief summary: In this single center study blood samples for biomarker analysis will be collected from patients with spinal muscular atrophy. Up to 21 mL blood will be drawn from eligible patients at a single visit.


Eligibility criteria: Inclusion Criteria:

* Self-identified as 5q-autosomal recessive spinal muscular atrophy (SMA) type I, II or III as judged by their neurologist upon diagnosis
* Ability and willingness to provide blood samples
* Willingness (by the patient or patient's parents or legal guardian) to complete to their best ability a questionnaire which requests specific clinical and genetic information
* Able to participate and willing to give written informed consent or assent. Informed consent will be obtained from the patient, or the patient's parent or legal guardian.

Exclusion Criteria:

* Any known genetic condition other than spinal muscular atrophy, unless it is not interfering with the purpose of this study based on the Sponsor's judgment
* Participation in a clinical trial (except observational studies) within the previous 14 days
* Donation of blood or significant blood loss within three months prior to screening
* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of this study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study

Primary outcomes:
measure: SMN1/SMN2 detection in blood by mRNA assay
timeFrame: 1 day
Secondary outcomes:
measure: SMN protein level in blood/lymphocytes
timeFrame: 1 day
Other outcomes:
Locations:
city: Kalamazoo
country: United States
state: Michigan
city: Salt Lake
country: United States
state: Utah
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03290768: Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3)
Official title: Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot (SMA Investigational Device)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: Savvysherpa, Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 358
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study allows Type 2 diabetics to receive feedback from a continuous glucose monitor (CGM) as part of an educational program designed to help them better manage their glucose levels. Subjects will also wear an activity tracker to monitor their activity and observe its effect on their glucose levels. The educational program will involve calls from coaches to check subjects' progress and answer questions.


Eligibility criteria: Inclusion Criteria:

* Be diagnosed with type 2 diabetes
* Be able to read and understand English
* Have access to a telephone
* Have a Medicare Advantage health plan through Senior Dimensions

Exclusion Criteria:

* Pregnant
* Blind
* Deaf
* Receiving chemotherapy or radiation to treat cancer (now or in past 6 months)
* Misusing any drugs (including alcohol, painkillers, hallucinogens, or others)
* Critically ill
* Diagnosed with or experiencing:

  * Kidney disease stages 4 and 5
  * End stage renal disease
  * Severe liver disease
  * Dementia
  * Schizophrenia
  * Bipolar disorder
  * Autism
  * An intellectual or learning disability
  * Arrhythmias other than atrial fibrillation
  * Congestive heart failure
* Has had a:

  * Myocardial infarction within the last 6 months
  * Stroke within the last 6 months
  * Stroke that resulted in significant disability (e.g., unable to write clearly or walk)

Primary outcomes:
measure: Program Enrollment Rate (%)
timeFrame: up to 9 months
measure: Program Completion Rate (%)
timeFrame: up to 9 months
Secondary outcomes:
measure: Weekly Average of Estimated Glucose Values (EGV)
timeFrame: up to 10 weeks
measure: Change in Medication Dosage (mg/Day; U/Day)
timeFrame: up to 9 months
measure: Average Age of Participants Who Start Trial (Yrs)
timeFrame: up to 9 months
measure: Average Age of Participants Who Complete Trial (Yrs)
timeFrame: up to 9 months
measure: Texting With Coaches
timeFrame: up to 9 months
measure: Coaching Participation Rate
timeFrame: up to 9 months
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Southwest Medical Associates
state: Nevada
Study officials:
References:
Clinical trial NCT00888368: Accuracy of the Transpatellar Tendon Approach to Knee Arthrocentesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Aspiration
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2009-04-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 determine the accuracy of intraarticular placement with the transpatellar tendon approach as compared to the suprapatellar approach. Patients undergoing knee arthroscopy will be consented for study of the injection of the fluid into the joint prior to portal placement or commencement of knee replacement. Patients will be randomized to receive injections via the transpatellar tendon or superolateral approach. Using injectable contrast and fluoroscopy, the placement of injections into the knee will be evaluated for accuracy. Injection attempts with contrast fluid that uniformly coats the articular surface on sagittal and coronal radiographs will be counted as successful. A concentration of contrast fluid in extraarticular fat will be counted as a failure.

Hypothesis: The rate of accuracy of intraarticular placement of the needle tip via the transpatellar tendon approach to knee aspiration is greater than that of the superolateral approach.

* To determine the distribution of contrast material with the transpatellar tendon and superolateral apporaches. Using a previously described evaluation technique of dividing the knee into seven compartments, sagittal and coronal fluoroscopy images will be evaluated to determine the distribution of contrast fluid.

Hypothesis: Contrast injected into the knee via the trasnpatellar tendon approach will penetrate as many compartments of the knee as contrast injected via the superolateral approach.


Eligibility criteria: Inclusion Criteria:

* undergoing elective arthroscopic surgery of the knee
* age greater than 18 years old and less than 80 years old
* able to consent to a research study

Exclusion Criteria:

* allergy to contrast dye, iodine or shellfish
* currently pregnant
* acute fracture or dislocation

Primary outcomes:
measure: The development of an easier approach to aspirating the knee may lead to improved accuracy of intraarticular needle placement by less experienced practitioners and more "anatomically difficult" knees.
timeFrame: 1 time (intraop)
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
References:
Clinical trial NCT06018168: An RCT Evaluating the Efficacy of a Skincare Routine and Acne Supplement on Improving Acne and Other Symptoms of PMS
Official title: A Randomized, Controlled Study Evaluating the Efficacy of a Skincare Routine and Acne Supplement or a Skincare Routine Alone on Improving Acne and Other Symptoms of PMS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne
Premenstrual Syndrome
Lead sponsor: Clearstem Skincare
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-08-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be conducted as a randomized, controlled trial in which participants will be split into two groups. Both will use the skincare routine, but one group will also take the MINDBODYSKIN supplement in combination with the skincare routine.
Primary purpose: OTHER

Brief summary: This study aims to evaluate the efficacy of the MINDBODYSKIN Hormonal Acne Supplement and a prescribed skincare routine of 6 products on facial acne and on symptoms of PMS, compared to a skincare routine of 6 products alone. This study will last for 24 weeks. The study will be conducted as a randomized, controlled trial in which participants will be split into two groups. Both will use the skincare routine, but one group will also take the MINDBODYSKIN supplement in combination with the skincare routine.


Eligibility criteria: Inclusion Criteria:

Female 18 years of age or older Have regular acne Have any noticeable PMS symptoms like stress, bloating, mood swings, acne Be generally healthy (i.e. don't live with any uncontrolled chronic disease besides acne).

Have a body weight of \>120 lbs.

Exclusion Criteria:

Have any pre-existing conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.

Be currently using any prescribed medications for their face Anyone with any known severe allergic reactions Women who are pregnant, breastfeeding or attempting to become pregnant Anyone unwilling to follow the study protocol

Primary outcomes:
measure: Changes in facial acne. [Baseline to Week 24]
timeFrame: 24 weeks
measure: Changes in blood serum levels of vitamin A. [Baseline to Week 24]
timeFrame: 24 weeks
measure: Changes in participants perception of facial acne. [Baseline to Week 24]
timeFrame: 24 weeks
Secondary outcomes:
measure: Changes in symptoms of premenstrual syndrome (PMS). [Baseline to Week 24]
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT04601168: Assessment of the Safety and Performance of a Compression Knee Support in the Prevention of Injuries During Sports Practice
Official title: Assessment of the Safety and Performance of a Compression Knee Support in the Prevention of Injuries During Sports Practice
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Knee Pain
Chronic Instability of Knee Joint
Lead sponsor: Decathlon SE
Sponsor class: INDUSTRY
Collaborators: name: EFOR, France
First posted: 2020-10-23
Enrollment: 7
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: Subject with chronic pain AND / OR chronic knee instability whose current condition of his/her knee allows him/her to pursue a usual physical activity.

Brief summary: Decathlon has developed kneeSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeSOFT100 product to demonstrate safety and performance of this device in a real-world setting.


Eligibility criteria: Inclusion Criteria:

* Subject is aged ≥18 years old
* Subject has chronic pain AND / OR chronic knee instability
* The current condition of his/her knee allows the subject to resume usual physical activity
* Subject has been informed and is willing to sign an informed consent form
* Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks)
* Subject is affiliated to the French social security regime

Exclusion Criteria:

* Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
* Subject has worn a support (knee brace or articulated orthosis) during sports sessions during the last month
* Subject has any medical condition that could impact the study at investigator's discretion
* Subject has a known hypersensitivity or allergy to the components of the device (elastodiene, polyester)
* Adult subject to a legal protection measure

Primary outcomes:
measure: Functional score
timeFrame: 6 weeks of follow-up
Secondary outcomes:
measure: Confidence level
timeFrame: At baseline and 6 weeks of follow-up
measure: Knee instability
timeFrame: At 2 weeks and 6 weeks of follow-up
measure: Knee pain
timeFrame: At 2 weeks and 6 weeks of follow-up
measure: Safety (adverse events)
timeFrame: 6 weeks of follow-up
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Paris
country: France
facility: KOSS Paris 8
Study officials:
affiliation: Centre Hospitalier Universitaire de Lille
name: Valérie WIECZOREK
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03507868: YKL-40 and IL-6 Levels in Periodontal Disease
Official title: Effect of Non-Surgical Periodontal Therapy on Salivary and Gingival Crevicular Fluid YKL-40 and IL-6 Levels in Chronic Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 52
Sex: ALL
Minimum age (years): 26
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 52 participants

Brief summary: The primer aim of the study was to investigate saliva and gingival crevicular fluid (GCF) YKL-40 and also interleukin-6 (IL-6) levels in chronic periodontitis pathogenesis.

Detailed description: This study consisted of two groups: 26 periodontally healthy individuals and 26 generalized chronic periodontitis patients. Chronic periodontitis patients were received nonsurgical periodontal treatment. Clinical measurements were recorded, saliva and GCF samples were obtained before and at first and third months after periodontal therapy. Levels of YKL-40 and IL-6 in saliva and GCF were analyzed by enzyme-linked immunosorbent assay.

Eligibility criteria: Inclusion Criteria:

Group 1 Inclusion Criteria:

* No bone and attachment loss,
* GI=0, PPD≤3mm, CAL≤3mm
* Systematically healthy patients

Group 2 Inclusion Criteria:

* GI\>1, PPD≥5mm, CAL≥5mm with alveolar bone loss radiographically.
* Systematically healthy patients

Exclusion Criteria:

* Aggressive Periodontitis,
* Patients with any other systemic diseases,
* Pregnant women and those in the lactation period,
* Patients with smoking habit and taking medication
* Patients received periodontal therapy in last 6 month

Primary outcomes:
measure: YKL-40 levels
timeFrame: at first and third month after therapy
Secondary outcomes:
measure: IL-6 levels
timeFrame: at first and third month after therapy
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02751268: Effect of Infraorbital and Infratrochlear Nerve Block on Emergence Agitation in Patients Undergoing Septorhinoplasty
Official title: Effect of Infraorbital and Infratrochlear Nerve Block on Emergence Agitation in Patients Undergoing Septorhinoplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Emergence Agitation
Pain
Keywords: infraorbital nerve block
infratrochlear nerve block
septorhinoplasty
general anesthesia
postoperative analgesia
Lead sponsor: Armed Forces Hampyeong Hospital
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether bilateral infraorbital and infratrochlear nerve block in patients undergoing septorhinoplasty are effective in preventing emergence agitation.

Detailed description: Emergence agitation is a postanesthetic phenomenon characterized as confusion, disorientation and violent behavior. Although its etiology is not well understood, risk factors associated with the condition include pain and ENT (ear, nose and throat) surgery. Bilateral infraorbital and infratrochlear nerve block in patients undergoing septorhinoplasty is effective in treating postoperative pain. The investigators have designed this study to evaluate the effect of infraorbital and infratrochlear nerve block on emergence agitation in patients undergoing septorhinoplasty.

Eligibility criteria: Inclusion Criteria:

* Septorhinoplasty
* American Society of Anesthesiologists (ASA) classification I-II
* Written informed consent

Exclusion Criteria:

* ASA classification greater than III
* Allergy to ropivacaine
* Incapability to give consent
* Chronic pain
* Coagulopathy

Primary outcomes:
measure: Emergence agitation
timeFrame: 2 hours after surgery
Secondary outcomes:
measure: Pain intensity
timeFrame: 2, 8, 24, 48 hours after surgery
measure: Patient satisfaction
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Geumgye-ri
country: Korea, Republic of
facility: Armed Forces Hampyeong Hospital
state: Haebo-myeon, Hampyeong-gun, Jeollanam-do
Study officials:
affiliation: Armed Forces Hampyeong Hostpital
name: Hoon Choi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HJ, Kim DK, Kim HY, Kim JK, Choi SW. Risk factors of emergence agitation in adults undergoing general anesthesia for nasal surgery. Clin Exp Otorhinolaryngol. 2015 Mar;8(1):46-51. doi: 10.3342/ceo.2015.8.1.46. Epub 2015 Feb 3.
citation: Boselli E, Bouvet L, Augris-Mathieu C, Begou G, Diot-Junique N, Rahali N, Vertu-Ciolino D, Gerard C, Pivot C, Disant F, Allaouchiche B. Infraorbital and infratrochlear nerve blocks combined with general anaesthesia for outpatient rhinoseptoplasty: A prospective randomised, double-blind, placebo-controlled study. Anaesth Crit Care Pain Med. 2016 Feb;35(1):31-36. doi: 10.1016/j.accpm.2015.09.002. Epub 2015 Nov 5.