louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02566733: Minto Model in Effect Site Mode for Target-Controlled Infusion of Remifentanil During Cardiopulmonary Bypass
Official title: Performance of the Minto Model in Effect Site Mode for Target Controlled Infusion of Remifentanil During Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthetics, Intravenous
Pharmacology
Anesthetics
Cardiopulmonary Bypass
Keywords: remifentanil
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 56
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: TREATMENT

Brief summary: Target controlled infusion with remifentanil is widely used during cardiac surgery, wich is performed using the Minto model. It was derived from patients undergoing general surgery. However, pharmacokinetics of remifentanil can be changed during cardiopulmonary bypass. The investigators tested whether Minto model for target controlled infusion produces constant plasma remifentanil concentration during the cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Adult patients with the ASA class I\~III undergoing elective cardiac surgery using cardiopulmonary bypass

Exclusion Criteria:

* Patients not using target controlled infusion during the operation
* Patients with drug/substance abuse
* Patients using analgesics before this study starts
* Pregnant women
* Patients who rejected study participation

Primary outcomes:
measure: Median prediction error
timeFrame: during CPB
Secondary outcomes:
measure: changes of measured total remifentanil concentration
timeFrame: 1 hour after anesthesia induction, 30/60/90 min after the beginning of cardiopulmonary bypass, 1 hour after the end of cardiopulmonary bypass
measure: Median absolute prediction error
timeFrame: during CPB
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Tae Kyong Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06945133: Correlation Study Between the Classification of Arthrogenic Motor Inhibition (AMI) and Clinical Assessment After ACL Rupture
Official title: Correlation Study Between the Classification of Arthrogenic Motor Inhibition (AMI) and Clinical Assessment After ACL Rupture
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ACL - Anterior Cruciate Ligament Rupture
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this interventional study is to measure medial vastus inhibition and associate it with AMI classification in patients with ACL rupture. The main question it aims to answer is:

Is there a correlation between AMI classification and clinical assessment after ACL rupture ? Participants will undergo surface EMG and Myotonometry.


Eligibility criteria: Inclusion Criteria:

* Patient, male or female, aged ≥ 18 years and \< 45 years
* Patient with an ACL rupture confirmed by MRI
* Patient with an ACL rupture ≤ 30 days old
* French speaking patient who does not object to the use of his/her data

Exclusion Criteria:

* Patient with previous ipsi or contralateral knee injury/surgery
* Patient with multi-ligament injury
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Muscle Surface EMG and AMI correlation
timeFrame: From enrollment to Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
Study officials:
References:
Clinical trial NCT06626854: Treating Chronic Knee Pain with Noninvasive Peripheral Nerve Stimulation Using Novel Interferential RadioFrequencies
Official title: Prospective, Randomized Study to Assess the Safety and Efficacy of the Novel Noninvasive Hypersound Neuromodulation System in the Treatment of Patients with Chronic Pain of Peripheral Nerve Origin
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Chronic Knee Pain
Chronic Knee Osteoarthritis
Post Surgical Neuropathic Pain
Keywords: rfPNS
Hypersound
Neuroharmonix
Noninvasive PNS
Lead sponsor: Hypersound Medical Inc
Sponsor class: INDUSTRY
First posted: 2024-10-04
Enrollment: 5
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: First, the subject will undergo screening and provide informed consent. Baseline measurements are then taken. The subject remains seated with back support throughout the session. The technician verifies and marks the knee for treatment and wraps an antenna applicator strap around the lower leg near the knee. The device is turned on in test mode to confirm the therapy location, with the subject identifying when they feel a sensation over their pain area. The power threshold for this sensation is recorded. The therapy, which lasts 15 minutes, is delivered at 90% of this threshold to ensure the subject does not feel it. After therapy, post-treatment measurements are taken.

Detailed description: 1. Subject will perform screening and informed consent
2. Baseline measurements will be taken
3. Subject will sit in chair with back support throughout duration of the session
4. Knee for treatment will be verified and marked
5. Technician will wrap antenna applicator strap around the lower leg, at the knee
6. Device is turned on and set to test mode to verify therapy location. Subject will verify when they feel a sensation covering their existing chronic knee pain. The power threshold for sensation is recorded.
7. Therapy begins and lasts for 15 minutes, power threshold is set to 90% so that the subject does not feel the therapy
8. At the end of 15 minutes, post-therapy measurements are recorded

Eligibility criteria: Inclusion Criteria:

* Pain greater than mid-range using standardized pain inventory (SPI).
* No medication for pain both over-the-counter and by prescription for 24 hours prior to treatment.
* Body mass index (BMI) to be calculated for all participants with limitation for any BMI that is lower than normal. (Target is normal, overweight or obese).
* Age greater than 18.

Exclusion Criteria:

* Existing Peripheral Nerve Stimulator Implant in the lower extremities

Primary outcomes:
measure: VAS
timeFrame: 3 months
Secondary outcomes:
measure: Disability
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02124954: A Preliminary Drug Drug Interaction Study With TA-8995
Official title: A Phase I, Open Label Study to Assess the Effects of TA-8995 on the Pharmacokinetics of Midazolam and Digoxin in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetic Interactions
Lead sponsor: Xention Ltd
Sponsor class: INDUSTRY
First posted: 2014-04-28
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: A study in healthy males to look at how multiple doses of TA-8995 affect blood levels and rate of removal of other drugs, using single doses of digoxin and midazolam as examples, to see if there are any potential drug interactions that might affect patients in future studies. The study will examine whether co-administration of TA-8995 affects the pharmacokinetics of digoxin and midazolam measured by area under the curve (AUC).


Eligibility criteria: Inclusion Criteria

* Healthy male subjects

Exclusion Criteria

* Receiving any other drug therapy
* Clinically significant medical history
* Abnormal laboratory results or ECGs

Primary outcomes:
measure: Plasma concentrations of TA-8995, midazolam and digoxin
timeFrame: Over 16 days
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance
Study officials:
affiliation: Covance
name: Ashley Brooks
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03588754: Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking?
Official title: Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Alcohol Drinking
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-07-17
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For this protocol, the investigators plan to conduct a pilot study evaluating the effect of propranolol on alcohol consumption. Using a parallel design, the investigators plan to randomize 20 non-treatment seeking adults with alcohol use disorders (DSM-5) to propranolol extended release (160mg/day or placebo; n=10 per cell) to evaluate whether propranolol reduces alcohol self-administered in the laboratory. Importantly, the investigators will evaluate whether propranolol counteracts stress-induced effects on alcohol self-administration. Following titration to steady state medication levels over a 2-week period, each subject will complete two laboratory sessions consisting of a well validated method for inducing stress or neutral/relaxing state (order counterbalanced), followed by a 2-hour alcohol self-administration paradigm known to be sensitive to medication effects.


Eligibility criteria: Inclusion Criteria:

1. Age 21-65
2. Able to read and write English
3. Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for current (past 6 months) alcohol use disorders
4. Able to take oral medications and willing to adhere to medication regimen

Exclusion Criteria:

1. Participants with any significant current medical conditions.
2. Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or IUD)
3. Suicidal, homicidal or evidence of current (past 6-month) mental illness.
4. Specific exclusions for administration of propranolol not already specified.
5. Subjects likely to exhibit clinically significant alcohol withdrawal during the study.

Primary outcomes:
measure: Alcohol consumption
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Professor
name: Sherry McKee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06327854: NUtrition and ORal Health in Orthopaedic Surgery
Official title: Study of the Relationship Between Dietary Aspects and Oral Hygiene in Patients Undergoing Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Orthopedic Disorder
Metabolism and Nutrition Disorder
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 64
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults patients undergoing elective major orthopedic surgery, such as hip, knee, or spine surgery.

Brief summary: This prospective observational study evaluates the relationship between the objective oral health status and the patient reported diet in 64 adult patients undergoing elective major orthopaedic surgery (hip, knee, or spine surgery).


Eligibility criteria: Inclusion Criteria:

* Age ≥55
* Male and female gender
* Major elective orthopedic surgery (hip, knee, spinal)
* Signature of the informed consent

Exclusion Criteria:

* Inability to follow the study protocol
* Neuropsychiatric disease, developmental disorders

Primary outcomes:
measure: Association between pre-operative oral health and diet
timeFrame: Day before surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Study officials:
affiliation: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
name: Matteo Briguglio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001254: Evaluating Pancreatic Tumors in Patients With Zollinger-Ellison Syndrome
Official title: Evaluation of the Gastrinoma in Patients With Zollinger-Ellison Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Zollinger Ellison Syndrome
Keywords: Zollinger-Ellison Syndrome
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient population enrolled in protocol 89-DK-0015

Brief summary: This protocol concerns the approach to the localization, diagnosis of MEN1 and management of the tumor and the tissue samples in patients with Zollinger-Ellison syndrome. It details the diagnostic imaging tests to be used to localize the tumor, investigations for MEN1 the subsequent management of the tumor and tissue samples for research....

Detailed description: This protocol concerns the approach to the localization and management of the tumor in patients with Zollinger-Ellison syndrome. It details the diagnostic imaging tests to be used to localize the tumor and the subsequent management of the tumor.

Eligibility criteria: * INCLUSION CRITERIA:

New patients will be evaluated initially as described in the protocol entitled, "Diagnostic evaluation of patients with suspected abnormalities of gastric secretion" (89-DK-0005).

Only those patients that are being treated under the protocol entitled, "Medical Therapy of Zollinger-Ellison Syndrome" (protocol # 89-DK-0015) will be entered into this tumor localization and management protocol.

Primary outcomes:
measure: To determine an approach to the localization and management of tumor in patients with ZES.
timeFrame: Yearly
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Robert T Jensen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolfe MM, Jensen RT. Zollinger-Ellison syndrome. Current concepts in diagnosis and management. N Engl J Med. 1987 Nov 5;317(19):1200-9. doi: 10.1056/NEJM198711053171907.
citation: Andersen DK. Current diagnosis and management of Zollinger-Ellison syndrome. Ann Surg. 1989 Dec;210(6):685-703. doi: 10.1097/00000658-198912000-00001.
citation: Creutzfeldt W, Arnold R, Creutzfeldt C, Track NS. Pathomorphologic, biochemical, and diagnostic aspects of gastrinomas (Zollinger-Ellison syndrome). Hum Pathol. 1975 Jan;6(1):47-76. doi: 10.1016/s0046-8177(75)80109-2.
Clinical trial NCT00004354: Study of Prevalence and Clinical Phenotype in Patients With Glucocorticoid-Remediable Aldosteronism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperaldosteronism
Keywords: endocrine disorders
genetic diseases and dysmorphic syndromes
hyperaldosteronism
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Brigham and Women's Hospital
First posted: 1999-10-19
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Determine the prevalence of glucocorticoid-remediable aldosteronism (GRA) in various hypertensive populations and screen at risk members of GRA pedigrees.

II. Investigate other factors regulating blood pressure in GRA (environmental, genetically determined factors).

III. Investigate renal and hormonal mechanisms regulating potassium homeostasis in GRA.

IV. Describe clinical phenotype of GRA patients. V. Prospectively screen GRA-affected patients with MRI angiography for intracranial aneurysm.

Detailed description: PROTOCOL OUTLINE:

Patients are screened for high blood pressure, suppressed plasma renin activity level, and low potassium levels. Urine is collected for a 24 hour period. Blood specimen is collected for molecular biologic evaluation for the presence of the chimeric gene diagnostic of GRA. Any history of cardiovascular events is recorded.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnosed glucocorticoid-remediable aldosteronism (GRA) with hypertension Hypokalemia is variably seen Blood pressure variably elevated Elevated level of aldosterone Low level of plasma renin activity

Primary outcomes:
Secondary outcomes:
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: Robert G. Dluhy
role: STUDY_CHAIR
References:
Clinical trial NCT02938754: Rehabilitation Gaming System for Cerebral Palsy
Official title: Motor and Cognitive Training With the Rehabilitation Gaming System for Patients Affected by Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Movement Disorder
Keywords: Hemiparesis
Functional independence
Virtual Rehabilitation
Lead sponsor: Universitat Pompeu Fabra
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 14
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the investigators evaluate the effectivity of Virtual Reality-based rehabilitation protocols for preventing motor deterioration in patients with cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* Children and Adult patients between 12- 50 years old diagnosed with CP according to Gross Motor Function Classification System (GMFCS). Level of disability between I and IV.
* Ashworth modified clinical scale \< 3 (Ashworth, 1964, Bohannon Bohannon and Smith, 1987).

Exclusion Criteria:

* Severe visual impairment.
* Severe cognitive impairment such as mental retardation which impedes the understanding of the task.

Primary outcomes:
measure: Change in motor function of the affected extremity as measured by MACS clinical scale
timeFrame: Change from Baseline to week 5 (End of Treatment)
Secondary outcomes:
measure: Change in attention and visuo-perceptive and visuo-constructional apraxia as measured by the WAIS-III scale
timeFrame: Change from Baseline to week 5 (End of Treatment)
measure: Change in motor function of the affected extremity as measured by the Box and Blocks clinical scale
timeFrame: Change from Baseline to week 5 (End of Treatment)
measure: Change in the amount of use of the affected arm during training as measured by the Virtual Reality system
timeFrame: Change from Baseline to week 5 (End of Treatment)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Universitat Pompeu Fabra
Study officials:
affiliation: Center of Autonomous Systems and Neurorobotics
name: Paul FMJ Verschure, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cameirao MS, Badia SB, Duarte E, Frisoli A, Verschure PF. The combined impact of virtual reality neurorehabilitation and its interfaces on upper extremity functional recovery in patients with chronic stroke. Stroke. 2012 Oct;43(10):2720-8. doi: 10.1161/STROKEAHA.112.653196. Epub 2012 Aug 7.
citation: Wittenberg GF. Neural plasticity and treatment across the lifespan for motor deficits in cerebral palsy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:130-3. doi: 10.1111/j.1469-8749.2009.03425.x.
Clinical trial NCT03099954: Withings Pulse Wave Velocity and Blood Pressure Study
Official title: Withings Pulse Wave Velocity and Blood Pressure Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elevated Blood Pressure
Hypertension
Mental Stress
Sleep Disorders
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
Collaborators: name: Withings
First posted: 2017-04-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be an estimated 300 healthy adult subjects from the United States. This population will be approximately 150 men and 150 women

Brief summary: Measure pulse wave velocity stability in relation to time of day, day of the week, physical activity, sleep quality, stress levels and blood pressure.

Detailed description: The study population will be an estimated 300 healthy adult subjects from the United States. This population will be approximately 150 men and 150 women. In order to obtain a relatively diverse age range of users (with varying levels of arterial stiffness), we hope to enroll participants across three age ranges entered in the Withings application by the user: 18-40 years, 41-60 years, and \> 60 years. These spots will be filled by those that satisfy the inclusion/exclusion criteria on a first come, first served basis.

Eligibility criteria: Inclusion Criteria:

* User of a (1) Withings blood pressure cuff (2) Withings activity tracker and (3) Withings Body Cardio scale
* User has measured their blood pressure at least once per week for the majority of weeks over the last three months.

Exclusion Criteria:

* Aortic artery disease
* Peripheral vascular disease
* Atrial fibrillation
* Weight \> 396 lbs.
* Pregnant women

Primary outcomes:
measure: Measure pulse wave velocity (PWV) stability in relation to time of day, day of the week, physical activity, sleep quality, stress levels and blood pressure.
timeFrame: Subjects will be expected to participate for a total of 16 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Translational Science Institute
state: California
Study officials:
affiliation: Scripps Translational Science Institute
name: Brian D Modena, MD
role: PRINCIPAL_INVESTIGATOR
References: