louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06803615: Noninvasive Mapping Before Surgical Ablation
Official title: The Use of Beat-to-Beat Noninvasive 3D Mapping to Study Patients Candidates for Concomitant Surgical Ablation for Persistent and Long-standing Persistent Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation (AF)
Keywords: Atrial Fibrillation
Electrocardiographic Imaging
Noninvasive Mapping
Surgical Ablation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with persistent or long-standing persistent atrial fibrillation scheduled for concomitant surgical ablation at Vienna General Hospital of the Medical University of Vienna.

Brief summary: The purpose of this study is to assess the electrophysiological mechanism of atrial fibrillation by means of a beat-to-beat noninvasive 3D mapping method in patients with concomitant persistent and long-standing persistent atrial fibrillation undergoing surgical ablation.


Eligibility criteria: Inclusion Criteria:

* legal age (18-90a)
* life expectancy \> 2 years
* patients suffering from persistent and long standing atrial fibrillation
* scheduled for concomitant surgical ablation
* possibility to follow-up
* given informed consent

Exclusion Criteria:

* vulnerable patient groups
* pregnancy
* any previous surgical ablation
* acute surgical indications
* any physical condition that leads to a life expectancy of less than two years
* any contraindication to the treatments necessary for the trial's conduction as e.g.

  * known allergic reaction to contrast agent
  * known allergic reaction to antiarrhythmic drugs
  * claustrophobia or anxiety in small spaces
  * severe renal impairment
  * unmanageable hyperthyroidism
* participation in any other clinical trial that either excludes enrolment or may be a confounding factor to results
* voluntary retention

Primary outcomes:
measure: The patients electrophysiological mapping results acquired with ECGI will be analyzed: Number and distribution of rotor and focal activities will be measured.
timeFrame: Prior to the planned procedure.
Secondary outcomes:
Other outcomes:
measure: Freedom from AF during 12 and 24 months of follow-up.
timeFrame: From surgery until 24 months after the procedure.
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Emilio Osorio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04264715: Evaluation of the Impact of Germicidal Light (Indigo-Clean) on Intraoperative S. Aureus Exposure
Official title: Evaluation of the Impact of Germicidal Light (Indigo-Clean) on Intraoperative S. Aureus Exposure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pathogen Transmission
Lead sponsor: Northwestern Medicine
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 824
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Operating room S. aureus exposure has been directly linked to postoperative infections and is therefore an important target for infection prevention. Visible light (non-ultraviolet spectrum) at 405nm has been shown to be germicidal. We hypothesize that use of this light in operating rooms will reduce S. aureus transmission occurring within and between patients and reduce surgical site infections (SSIs). Visible light is safe for routine, continual exposure, and is less harmful than sunlight. We plan to install ambient, germicidal lighting in 4 operating rooms. This ambient light is not directly applied to patients (does not involve the surgical procedure lights). Patients will undergo surgery according to usual practice. We will conduct a case-control study where operating rooms with surgeries with the lights are matched to operating rooms with surgeries without lights.

In Aim 1, 4 OR-pairs will be observed each day over an anticipated 103 working days for the primary outcome of S. aureus transmission events over a total minimum study period of 5.2 months (103 working days).


Eligibility criteria: Inclusion Criteria:

* Operating Rooms with and without the bactericidal lights where adult patients undergoing orthopedic, cardiothoracic, gynecology/oncology, and neurological surgery.

Exclusion Criteria:

* Operating Rooms with and without the bactericidal lights where pediatric, incarcerated, and/or pregnant patients undergoing surgery outside of the classifications above.

Primary outcomes:
measure: Staphylococcus aureus transmission rate
timeFrame: sequential surgeries on the same 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Forest
country: United States
facility: Northwestern Lake Forest Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT00000215: IV Cocaine Abuse: A Laboratory Model - 4
Official title: IV Cocaine Abuse: A Laboratory Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Columbia University
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of pergolide on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving in non-opiate dependent cocaine users.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Direct cocaine effects (cardio, subjective)
measure: Interaction of cocaine/pergolide on cardio
measure: Interaction of coc/pergolide on coc's subjective
measure: Effects of pergolide on cocaine craving
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Richard Foltin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02379715: Effect-site Concentration of Remifentanil for Smooth Induction With Desflurane
Official title: Effect-site Concentration of Remifentanil for Smooth Induction With Desflurane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Keywords: Remifentanil
smooth induction
desflurane
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Desflurane is a halogenated ether with low solubility, giving rapid induction and emergence from anesthesia This character is suitable for Volatile Induction and Maintenance Anesthesia (VIMA). But desflurane can cause airway irritation when it used as a sole induction agent to adult or children, so there were many studies about reducing the airway reflex combined with desflurane.

Remifentanil is a short acting opioid and is quickly hydrolyzed by nonspecific esterase in the plasma and multiorgan. Several studies suggest the optimal dose of remifentanil for reducing airway reflex or cardiovascular response for intubation combined with desflurane. But these studies were under 1 Minimal Alveolar Concentration (MAC) of desflurane and this point could be a limitation because desflurane concentration over 1 MAC increase airway irritation significantly. This study this study was designed to determine a median effective effect-site concentration (EC50) of remifentanil to prevent airway irritation during desflurane anesthesia over 1 MAC.


Eligibility criteria: Inclusion Criteria:

* patients for surgery requiring general anesthesia
* American Society of Anesthesiologists(ASA) classification I, II

Exclusion Criteria:

* history of gastroesophageal reflux, High grade obesity, Predicted difficult airway, Asthma, Chronic obstructive pulmonary disease(COPD), Upper respiratory infection (URI) within 3 weeks

Primary outcomes:
measure: Fail or success for induction with desflurane
timeFrame: After loss of consciousness, 5 seconds
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ajou University School of Medicine
name: Yoonjeong Chae, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00210015: A Study in Subjects With Perennial Allergic Rhinitis
Official title: A Multi-Center, Randomized, Parallel-Group, Double-Blind, Efficacy and Safety Study of INS37217 Nasal Spray Versus Placebo in Subjects With Perennial Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Perennial Allergic Rhinitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 630
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the efficacy and safety of the study drug compared to placebo for the treatment of subjects with perennial allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Have a documented history of allergy to perennial allergens and demonstrated sensitivity by the results of prick or intradermal skin testing.
* Have a self-reported history of at least mild, intermittent rhinorrhea and nasal blockage/stuffiness due to allergies.
* Have not started or had a change in immunotherapy regimen.

Exclusion Criteria:

* Have a physical obstruction in the nose.
* Will likely have an acute increase in severity of allergic rhinitis due to seasonal aeroallergens during the trial.
* Have acute or chronic sinusitis or had previous sinus surgery resulting in a significant change in the sinus or nasal anatomy.
* Have rhinitis medicamentosa or any other acute or chronic condition that could confound evaluations of nasal symptoms.
* Have asthma of sufficient severity to require use of excluded medications.
* Have taken any medications excluded as listed in the protocol.
* Have a clinically significant acute or chronic disease or clinically significant laboratory abnormality.
* Are a current smoker, recent smoker or past smoker as defined in the protocol.

Primary outcomes:
measure: total nasal symptom score
Secondary outcomes:
measure: average total nasal symptom scores over various timepoints average individual symptom scores
measure: global assessment of perennial allergic rhinitis symptoms
measure: instantaneous assessment of symptoms
measure: change from baseline in quality of life assessments
measure: physical and anterior nasal exams
measure: laboratory tests
measure: ECG
measure: vital signs
measure: adverse events
Other outcomes:
Locations:
Study officials:
name: Amy Schaberg, B.S.N.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02149615: Antiacne Medications Pseudotumor Cerebri
Official title: Prospective Open-label Phase IV Trial to Investigate the Frequency of Optic Disc Swelling, Idiopathic Intracranial Hypertension and Dry Eye Symptoms Under Antiacne Medication Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Optic Disc Swelling
Keywords: idiopathic intracranial hypertension
optic disc swelling
antiacne medication
isotretinoin
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University Hospital, Zürich
First posted: 2014-05-29
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The exact incidence of optic disc swelling and idiopathic intracranial hypertension in patients using antiacne medication is not known so far. The investigators hypothesize that swelling of retinal nerve fibre layer measured by optical coherence tomography is more frequent then assumed so far.

Detailed description: Measurement of retinal nerve fibre layer using optical coherence tomography over a period of 6 to 9 months depending on exact antiacne medication.

Eligibility criteria: Inclusion Criteria:

* Antiacne medication treatment indicated by dermatologist
* age \> 18 years
* contraception if indicated

Exclusion Criteria:

- age \< 18 years

Primary outcomes:
measure: Retinal nerve fibre layer
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
state: ZH
Study officials:
affiliation: UniversityHospital, Zurich
name: Klara Landau, Prof MD
role: STUDY_CHAIR
References:
Clinical trial NCT02713815: Novel Intervention for Amphetamine-type Stimulants Addiction
Official title: The Repetitive Transcranial Magnetic Stimulation (rTMS) for Amphetamine-type Stimulants Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amphetamine Addiction
Keywords: Amphetamine-type stimulants
prefrontal-striatal circuits
rTMS
Glutamate/GABA
motivational and cognitive intervention
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Yunnan Institute For Drug Abuse
First posted: 2016-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The repetitive transcranial magnetic stimulation (rTMS) will be used to treat amphetamine-type stimulant (ATS) addiction.

Detailed description: The Glutamate and GABA deficits in prefrontal cortex play a vital role in ATS addiction and relapse, and proposed repetitive transcranial magnetic stimulation (rTMS) as a novel interventions. Focused on evaluating Glutamate/GABA functions in prefrontal cortex and functional connectivity with deep brain regions, neuropsychological tests, biochemical tests, magnetic resonance spectroscopy (MRS) and functional MRI will be used to investigate the neurobiological mechanism of ATS addiction and relapse. These methods will also be used to evaluate the efficacy of the novel intervention and investigate the mechanisms. The study will be very helpful to develop novel interventions in clinical practice and decrease ATS-related harm for both the patients and their families.

Eligibility criteria: Inclusion Criteria:

* In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
* Dextromanual

Exclusion Criteria:

* Have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc
* Have cognitive-promoting drugs in the last 6 months
* Other substance abuse or dependence in recent five years (except nicotine)
* Mental impairment, Intelligence Quotient (IQ) \< 70
* Mental disorders
* Physical disease

Primary outcomes:
measure: Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month
timeFrame: Baseline and 1 month
Secondary outcomes:
measure: Number of participants who relapse
timeFrame: 1 month
measure: Depression status assessed by Patient Health Questionnaire-9(PHQ-9)
timeFrame: 1 month
measure: Anxiety status assessed by Generalized Anxiety Disorder Screener (GAD-7)
timeFrame: 1 month
measure: Cognitive function assessed by Cogstate Battery
timeFrame: 1 month
measure: Functional connectivity assessed by MRI
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Gaojing Rehabilitation Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Zhao Min, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01906515: Impact of SpHb Monitoring on Transfusion
Official title: Continuous and Noninvasive Hemoglobin Monitoring Reduces Red Blood Cell Transfusion During Neurosurgery: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: Anemia
Blood transfusion
non invasive hemoglobin monitoring
patient safety
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Masimo Corporation
First posted: 2013-07-24
Enrollment: 106
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Continuous and noninvasive hemoglobin (SpHb) monitoring provides clinicians with real-time trending of changes or lack of changes in hemoglobin, which has the potential to alter red blood cell (RBC) transfusion decision making. The objective of this study was to evaluate the impact of SpHb monitoring on RBC transfusions in high blood loss surgery. The investigators hypothesize that SpHb will improve blood transfusion practice in the for of change the number of blood unit per patient and improve the outcome regards the time to take decision of transfusion trigger.

Detailed description: Eligible patients scheduled for neurosurgeries were enrolled into either a standard care group (Control Group) or an intervention group (SpHb Group). The Control Group received typical anesthesia care including estimated blood loss (EBL) assessment and intraoperative hemoglobin measurements from the central laboratory (Hb). Blood samples were taken when EBL was ≥15% of total blood volume. RBC transfusion was initiated if Hb was ≤10 g/dL and continued until the EBL was replaced and Hb \>10g/dL was confirmed. The SpHb Group followed the same transfusion practice as the Control Group except the anesthesiologist was guided by the addition of SpHb monitoring with blood samples still taken pre- and post-transfusion. Additionally, the absolute and trend accuracy of SpHb compared to Hb was evaluated. Potential cost savings from reduced RBC utilization will be calculated if occured.

Eligibility criteria: Inclusion Criteria:

* ASA 1,2 patients from 15 to 60 years old scheduled for neurosurgical procedure

Exclusion Criteria:

* Exclusion criteria included significant liver or renal disease, coagulopathy, pregnancy, anemia, and patients scheduled for procedures with excepted low blood loss.

Primary outcomes:
measure: RBC Transfusions Per Subject Receiving a Transfusion
timeFrame: During surgery (an average of about 4 hours)
measure: The Effect of SpHb on Transfusion Timeline
timeFrame: During surgery (an average of about 4 hours)
Secondary outcomes:
measure: SpHb Absolute and Trend Accuracy
timeFrame: During surgery (an average of about 4 hours)
Other outcomes:
measure: Potential Cost Savings
timeFrame: During surgery (an average of about 4 hours)
Locations:
Study officials:
affiliation: Department of Anesthesia, ICU, and Pain Management, Cairo University, Egypt
name: Wael N Awada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00823615: Comparison of Two New Silicone Hydrogel Multifocal Products
Official title: Comparison of Two New Silicone Hydrogel Multifocal Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-01-15
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to compare the performance of two multifocal contact lenses.


Eligibility criteria: Inclusion Criteria:

* At least 35 years of age
* Best-corrected visual acuity of at least 20/40 in each eye.
* Spectacle add between +0.75D and +1.50D (inclusive).
* Able to be fit in available study sphere powers (-0.50 to -5.50D).
* Currently wearing soft contact lenses at least 5 days a week.
* Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Requires concurrent ocular medication.
* Eye injury or surgery within twelve weeks immediately prior to enrollment.
* Currently enrolled in an ophthalmic Clinical Trial.
* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
* Previous refractive surgery.
* Astigmatism \> 1.00D.
* Currently wearing ACUVUE OASYS for PRESBYOPIA.
* Other protocol inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity
timeFrame: After 1 week of wear
measure: Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity
timeFrame: After 1 week of wear
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04643015: New Ways of Doing Magnetic Resonance Imaging in Children and Adults
Official title: New Image Techniques for Magnetic Resonance Imaging in Children and Adults
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pediatric Disorder
Adult Disease
Keywords: Magnetic Resonance Imaging
MRI
20-482
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSK). With consultation of the clinical team, the investigator or a consenting professional from the research team will go to the treating physician's clinic to discuss the study and consent the patient in person.

Brief summary: This study is being done to see how we can prevent problems caused by movement during the MRI scan. Different ways of doing the scan (techniques) will be tested to see if they are practical and can prevent problems related to motion. For example, changes in the timing of the magnetic field and the radio waves will be examined, and at changes in the way a computer is used to process the images. The new techniques will be compared with the techniques that are usually used.


Eligibility criteria: Inclusion Criteria:

* Patients of any age, including males and females, who are being treated in the Department of Pediatrics and are already scheduled to undergo MRI

Exclusion Criteria:

* Anyone who would normally be excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire for MRI (Appendix A). Subjects with pacemakers or aneurysm clips that are MRI conditional or MRI compatible may enroll in the study if the study is clinically indicated.
* Female patients who are pregnant
* Patients who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety
* Patients at higher risk due to age, frailty, or the emergent nature of their condition
* Patients who are undergoing MRI only of the head, neck or spine

Primary outcomes:
measure: Compare Image Quality
timeFrame: Day of MRI
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Gerald Behr, MD
role: PRINCIPAL_INVESTIGATOR
References: