louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02474680: Evaluation of Pharmacogenetic Testing In a Mental Health Population and Economic Outcomes
Official title: Evaluation of Pharmacogenetic Testing In a Mental Health Population and Economic Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder 1
Keywords: depression
Major Depressive Disorder
MDD
mental health
pharmacogenomics
personalized medicine
precision medicine
anti-depressants
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
First posted: 2015-06-18
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Participants must be enrolled in the Avera Care Coordination Program and have insurance coverage through the Avera Health Plans

Brief summary: This is a non-randomized, single-case design of pharmacogenetic implementation in a mental health patient population of subjects taking antipsychotics and/or antidepressants.

Detailed description: This is a non-randomized, single-case design of pharmacogenetic implementation in a mental health patient population of subjects taking antipsychotics and/or antidepressants. Retrospective and prospective data will be collected on all subjects before and after pharmacogenetic recommendations have been made. Retrospective data will be collected for the previous 12 months before pharmacogenetic recommendations are made and prospective data will be collected for 12 months after pharmacogenomic recommendations have been made.

Eligibility criteria: Inclusion Criteria:

* Must be taking either an anti-depressant or an anti-psychotic medication
* Must provide informed consent
* Must have Avera Health Plans insurance coverage
* Must have three months of participation in the Avera Care Coordination Program

Exclusion Criteria:

* Must not be pregnant or breastfeeding
* Must not have an active and/or unstable diagnosis of substance abuse
* Must not have a primary diagnosis of dementia, bulimia, or anorexia nervosa disorder
* Must not have had a previous pharmacogenetic evaluation

Primary outcomes:
measure: Depression scores
timeFrame: 12 months
Secondary outcomes:
measure: Economic impact of pharmacogenetic testing
timeFrame: 12 months
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera Institute for Human Genetics
state: South Dakota
Study officials:
affiliation: Avera McKennan Hospital & University Health Center
name: Matthew Stanely, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04437680: Retrospective Chart Review Study of Patients Treated With Votiva Device
Official title: Retrospective Chart Review Study of Patients Treated With Votiva Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vulvovaginal Signs and Symptoms
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A retrospective chart review of the medical records of 2 practices will be performed by investigators listed in the approved IRB protocol. Patients are seen at 1 site from August 2018 - May 2020, at 2nd site from September 2018 - February 2020 will be included. Patents who have received RF treatment with Votiva will be identified and selected.

Brief summary: retrospective data collection is to gain insight into patients satisfaction post Votiva treatments for the complex of vulvovaginal symptoms.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18years of age at the time of the procedure
* patients with symptoms of at least one of the following: vaginal relaxation syndrome, vaginal atrophy, vaginal dryness, dyspareunia, SUI, Vaginal laxity, recurrent UTI, recurrent vaginal infections, Linchen Sclerosis, perineal pain, itchiness.
* At least one Votiva procedure that included FormaV applicator treatment with or without combination with Fractora/Morpheus8 Applicators treatments

Exclusion Criteria:

* active infection, collagen disorders, immunocompromised state, medications that mitigate inflammatory response, and propensity for keloid/hypertrophic scarring.

Primary outcomes:
measure: Participant satisfaction post treatment
timeFrame: 4 weeks post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hilton Head Island
country: United States
facility: Advanced Women's Care of the Lowcountry
state: South Carolina
city: Lubbock
country: United States
facility: Owen Health Group
state: Texas
Study officials:
References:
Clinical trial NCT04919980: TVMR With the Innovalve System Trial - Early Feasibility Study
Official title: TVMR With the Innovalve System Trial - Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Valve Regurgitation (Degenerative or Functional)
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2021-06-09
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Detailed description: The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Eligibility criteria: Inclusion Criteria:

* Clinically significant, symptomatic mitral regurgitation
* High risk for open-heart surgery
* Meets anatomical criteria

Exclusion Criteria:

* Unsuitable anatomy
* Patient is inoperable
* EF\<25%

Primary outcomes:
measure: Absence of implant or delivery related serious adverse events at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Technical success
timeFrame: Procedure
measure: Procedural success
timeFrame: 30 days
measure: NYHA functional class
timeFrame: 30 days, 3, 6, 12 months and annually up to 5 years
measure: Six-minute walk test
timeFrame: 30 days, 3, 6, 12 months and annually up to 5 years
measure: Quality of life improvement (KCCQ-12)
timeFrame: 30 days, 3, 6, 12 months and annually up to 5 years
measure: Reduction in MR grade
timeFrame: 30 days, 3, 6, 12 months and annually up to 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan Hospital and Health Systems
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Cornell
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian / Columbia University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science Universtiy
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Mayo Clinic
name: Chet Rihal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03413280: Preemptive Analgesic Effects of Rectus Sheath Block in Laparoscopic Cholecystectomy Patients
Official title: The Effectiveness of Preemptive Effect of Rectus Sheath Block and Intercostal Block on Postoperative Visceral Pain in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preemptive Peripheral Nerve Block
Pain, Postoperative
Acute Pain
Keywords: preemptive analgic effect
Rectus Sheath Block
laparoscopic cholecystectomy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to investigate the effectiveness of preemptive effect of rectus sheath block (RSB) and intercostal nerve block (ICNB) on postoperative visceral pain in laparoscopic cholecystectomy (LLC).

After induction of general anesthesia, group of patient is decided randomly. In Group pre, RSB and ICNB are performed with 0.25% Ropivacaine 40ml before the operation. In Group post, RSB and ICNB are performed with 0.25% Ropivacaine 40ml after the operation.

Measure the NRS and compare the rescue analgesic dose used at 0, 0.5, 1, 2, 6, 9, 18, and 24 hours after arrival at the recovery room.


Eligibility criteria: Inclusion Criteria:

1. adults between the ages of 20 and 80
2. scheduled laparoscopic cholecystectomy patient
3. ASA class 1 or 2
4. Patients who have voluntarily agreed in writing to participate in the trial

Exclusion Criteria:

1. Patient with side effects on local anesthetics or steroids
2. Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc.
3. Patients with uncontrolled medical or psychiatric problem
4. Patient does not agree to participate in the study
5. Patients who are pregnant or lactating
6. Patients whose visceral pain is expected to be too severe
7. Patients receiving a single laparoscopic cholecystectomy (including using a robot)

Primary outcomes:
measure: Difference of analgesic consumption between both group
timeFrame: at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation
Secondary outcomes:
measure: compare the Numeric rating scale (NRS)
timeFrame: at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Asan Medical Center
name: JongHyuk Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03014180: Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)
Official title: Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure, CRT
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2017-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the LEVEA study is to assess the performances of a new automatic left ventricular auto threshold (LVAT) algorithm (In-Clinic LVAT algorithm) when used by physicians during in-hospital follow-up.

Detailed description: "In-Clinic LVAT" feature is a non CE-marked feature designed to be activated by the physician during 2 hospital follow-ups:

* first visit: planned to be conducted 15 days maximum after inclusion
* second visit: planned to be conducted between 1 and 3 months after the first visit The evaluation consists in the comparison between the threshold value provided by the algorithm and the threshold value obtained manually by the physician.

Eligibility criteria: Inclusion Criteria:

* Subject already implanted (de-novo, upgrade or replacement) according to the relevant ESC Guidelines \[1\]:

  * With IS1 Platinium SonR CRT-D (models 1811, 1841, CE-marked) for maximum of 5 days or;
  * With IS4 Platinium SonR CRT-D (model 1844, CE-marked).
* Right atrial, right and left ventricular leads must be implanted. Only bipolar and quadripolar for Left Ventricular lead.
* Reviewed, signed and dated informed consent.

Exclusion Criteria:

* Subject included in another clinical study that could confound the results of this study;
* Malfunction or dislodgment of right atrial, right and left ventricular implanted leads;
* Subject diagnosed with permanent atrial fibrillation;
* Known pregnancy;
* Minor age;
* Under protection or guardianship;
* Unavailability for scheduled follow-up or refusal to cooperate

Primary outcomes:
measure: Percentage of Successful"In-Clinic LVAT" Test
timeFrame: 0-3 months post inclusion
Secondary outcomes:
measure: Percentage of Accurate "In-Clinic LVAT" Test Assessed by an Independent Reviewer
timeFrame: 0-15 days post inclusion
measure: Percentage of Successful of "In-Clinic LVAT" Test at M0 Visit
timeFrame: 0-15 days post inclusion
measure: Percentage of Successful "In-Clinic LVAT" Test at M1 Visit
timeFrame: 1-3 months after first visit
measure: Percentage of Eligible Subjects to LVAT Feature
timeFrame: 0-3 months post inclusion
measure: Safety of the LVAT Algorithm
timeFrame: 0-3 months post inclusion
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
affiliation: CHRU de Brest, FRANCE.
name: Jacques Mansourati, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02890680: Effects of the Use of Platelet-rich Fibrin on Bone Regeneration After Impacted Third Molar Surgery
Official title: Randomized Double Blind Clinical Trial Evaluation of Bone Regeneration After Impacted Third Molar Surgery With the of Platelet-rich Fibrin: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibrin/Therapeutic Use
Blood Platelets
Molar, Third
Bone Regeneration
Keywords: platelet-rich fibrin
third molar
bone regeneration
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the bone regeneration after impacted third molar surgery on split mouth design using platelet-rich fibrin.


Eligibility criteria: Inclusion Criteria:

* Healthy patients
* Preoperative platelet count higher than 150,00/ mm3
* Patient who required bilateral mandibular third molar extractions

Exclusion Criteria:

* Smokers patients
* Alcoholics patients
* Patients whom the inferior second molar was missing
* Patients who had acute pericoronitis on the inferior third molar
* Severe periodontal disease

Primary outcomes:
measure: Change in bone density through tomography evaluation
timeFrame: Change from Baseline bone measurement at three months after surgery
Secondary outcomes:
measure: Change in periodontal-probing depth measurement on distal aspect of the second molar through Clinical evaluation
timeFrame: Change from baseline at 3 months after surgery
measure: Pain through Visual Analogue Scale
timeFrame: 1st day after surgery
measure: Pain through Visual Analogue Scale
timeFrame: 3rd day after surgery
measure: Pain through Visual Analogue Scale
timeFrame: 7th day after surgery
measure: Soft tissue healing through Clinical evaluation numeric scale
timeFrame: 7th day after surgery
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: João Canellas
Study officials:
affiliation: Rio de Janeiro University State
name: João Vitor Canellas, DDS; MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02776280: Oral Fluoride Bioavailability by the Consumption of Meals Prepared With Fluoridated Water or Salt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fluoridation
Keywords: water
salt
oral fluids
plaque
dental caries
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study will assess the concentration of fluoride in saliva and dental biofilm (fluid and solids) during and up to 2 hours after the consumption of typical Brazilian meals prepared with fluoridated water (0.7 ppm F) or fluoridated salt (250 mg F/kg). Typical Brazilian meals (rice, beans, meat with vegetables) will be prepared using fluoridated water, salt, or non-fluoridated water and salt. In an crossover design, twelve volunteers will eat 4.67 g of food/kg body weight of each meal, on fasting, during 15 min. Before the ingestion, unstimulated saliva and dental biofilm will be collected for determination of fluoride concentration. During the meal, 3 samples of the alimentary bolus (at 5, 10 and 15 min of mastication) will be collected for determination of fluoride concentration. Dental biofilm will be collected immediately after the ingestion of the meal. Saliva will then be collected after 5, 10, 15, 30, 60 and 120 min. All samples will be analyzed for fluoride using an ion-specific electrode. In order to standardize biofilm formation, during lead-in and wash-out periods, volunteers will: 1. brush their teeth with non-fluoride toothpaste; 2. refrain from brushing superior posterior teeth for 2 days before each phase; and 3. chew sucrose-containing chewing gum 5 times/day, for 10 min, during the 2 days prior to each phase. Groups will be compared by ANOVA and Tukey test.


Eligibility criteria: Inclusion Criteria:

* good general health
* good oral health
* not having used topical fluorides in the last 2 months

Exclusion Criteria:

* poor general health
* poor oral health
* breastfeeding
* expecting mothers

Primary outcomes:
measure: Fluoride concentration in the alimentary bolus
timeFrame: up to 15 min after start of the meal
measure: Fluoride concentration in saliva
timeFrame: up to 120 min after meal
measure: Fluoride concentration in dental biofilm
timeFrame: up to 120 min after the meal
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00813280: Barriers to the Implementation of Complete Insulin Order Sets
Official title: Barriers to the Implementation of Complete Insulin Order Sets in the Management of Individuals With Hyperglycemia or Diabetes at Park Nicollet Methodist Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperglycemia
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: International Diabetes Center at Park Nicollet
name: Park Nicollet Foundation
First posted: 2008-12-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hospitalized patients with blood glucose \>300 mg/dL

Brief summary: The major purpose of this Quality Improvement project is to begin to address the issues surrounding glycemic control in the hospital setting by collecting accurate, reliable and verifiable data on the occurrence of hyperglycemia (BG \>300 mg/dL), and whether or not CIO is used (immediately before and 72 hours after the BG \>300 mg/dl).


Eligibility criteria: Inclusion Criteria:

* Park Nicollet Methodist Hospital patient
* recorded BG \> 300 mg/dL during the study data collection period
* admitted to general floor hospital units

Exclusion Criteria:

* birth center
* intensive care units
* eating disorder unit
* pediatric patients \< 18 years of age
* patients receiving insulin infusions

Primary outcomes:
measure: glucose levels
timeFrame: 72 hours
Secondary outcomes:
measure: type of insulin treatment
timeFrame: 72 hours
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Park Nicollet Methodist Hospital
state: Minnesota
Study officials:
affiliation: Park Nicollet Health Services Endocrinology
name: Lisa Fish, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center at Park Nicollet
name: Robert M Cuddihy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
citation: Malmberg K, Ryden L, Efendic S, Herlitz J, Nicol P, Waldenstrom A, Wedel H, Welin L. Randomized trial of insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction (DIGAMI study): effects on mortality at 1 year. J Am Coll Cardiol. 1995 Jul;26(1):57-65. doi: 10.1016/0735-1097(95)00126-k.
Clinical trial NCT06431880: External Oblique Intercostal Plane Block Versus Thoracic Paravertebral Block for Post Thoracotomy Pain
Official title: External Oblique Intercostal Plane Block Versus Thoracic Paravertebral Block for Post Thoracotomy Pain: A Randomized Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: External Oblique Intercostal Plane Block
Thoracic Paravertebral Block
Post Thoracotomy Pain
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the effectiveness of analgesia achieved by external oblique intercostal plane block (EOIPB)and thoracic paravertebral block (TPVB) for postoperative pain management in patients undergoing open thoracotomy.

Detailed description: Acute thoracotomy pain is multifactorial in nature. It involves nociceptive and neuropathic mechanisms originating from somatic and visceral afferents. The main sources of pain are intercostal nerves, the vagus nerve and phrenic nerve in the pleura, the superficial cervical plexus, and the brachial plexus in the ipsilateral shoulder.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-III.
* Scheduled for open thoracotomy

Exclusion Criteria:

* Patients with neurological or intellectual disability.
* Infection at the injection site.
* Opioid addiction.
* Allergic reaction to local anesthetics.
* Coagulation abnormalities.
* Drug abuse.
* Pregnancy.
* Severe liver and/or renal failure.
* Uncontrolled hypertension.
* Severe cardiovascular problems.
* Diabetes mellitus.

Primary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperative
measure: Mean arterial pressure
timeFrame: Till the end of surgery
measure: Heart rate
timeFrame: Till the end of surgery
measure: Time to the 1st rescue analgesia
timeFrame: 24 hours postoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Complications
timeFrame: 24 hour postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: El-Gharbia Governorate, Egypt
Study officials:
References: