louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00174200: Study To Assess Differential Sensitivity Of 2 Spatial Working Memory Tests In Schizophrenics Treated With Risperidone
Official title: A Randomized, Double-Blind, Crossover Add-On Study To Assess The Differential Sensitivity Of 2 Spatial Working Memory Tests (The Groton Maze Learning Test [GMLT] And The Motor Delayed Response Test [MDR]) In Non-Agitated, Antipsychotic Drug-Naive First-Episode Schizophrenic Or Schizophreniform Patients Treated With Risperidone 2 Mg Daily Or Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Psychotic Disorders
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess the effect of risperidone 2 mg daily (QD) on the differential sensitivity of 2 spatial working memory tests (the GMLT and MDR) in non-agitated, drug-naive patients suffering from first-episode schizophrenia/schizophreniform disorder.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 to 50 years old, antipsychotic-naive, non-agitated patients diagnosed with first-episode schizophrenia or schizophreniform disorder.

Exclusion Criteria:

* Evidence or history of clinically significant medical or non-medical impairment that, in the opinion of the investigator, would affect the safety of the patient or interfere with the evaluation of the trial results;
* Patients who have a history of substance (which included alcohol) dependence within 12 months or abuse within 3 months of enrollment, or tested positive for an illicit drug on the Screening urine toxicology test
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Primary outcomes:
measure: Change from baseline on Day 8 and change from baseline on Day 15 in performance of the GMLT and MDR tasks.
Secondary outcomes:
measure: Additional descriptive analyses: Change from baseline in ESRS, PANSS, SOFAS, SRDEQ, and AVM on D8+15; CGI-C on D8+15
measure: -Change from baseline in GMLT, ODR, ESRS, PANSS, SOFAS, SRDEQ, AVM on D43; CGI-C on D43
measure: -ESRS will also be performed on D4+11
Other outcomes:
Locations:
city: Dartmouth
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06215300: The Effect of Polymorphism of the GUCY1A3 rs7692387 Gene on Cardiovascular Events After Coronary Artery Bypass Grafting.
Official title: The Effect of Polymorphism of the GUCY1A3 rs7692387 Gene on Cardiovascular Events After Coronary Artery Bypass Grafting.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: to Evaluate the Association of GUCY1A3 rs7692387 Gene Polymorphism Carrier on the Development of Cardiovascular Events After Coronary Artery Bypass Grafting
Keywords: cardiovascular system, coronary artery bypass grafting, aspirin resistance, GUCY1A3 gene polymorphism rs7692387, soluble guanylate cyclase (rGC)
Lead sponsor: Novosibirsk Scientific Research Institute for Circulatory Pathology
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 800
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: PROBABILITY_SAMPLE
Study population: patients with IHD

Brief summary: Polymorphism in the GUCY1A3 gene worsens the activity of rCC, causing vasoconstriction and increased platelet aggregation. Studies have shown the association of the GUCY1A3 gene with the risk of coronary heart disease and its complications, with ischemic stroke

Detailed description: Acetylsalicylic acid is indicated for the prevention of cardiovascular complications after CABG. Class I. The level of evidence A. ECS recommendations, Russian recommendations of cardiologists. However, the main problem of CABG remains thrombotic and thromboembolic complications in the immediate and long-term postoperative period, despite taking acetylsalicylic acid. According to various sources, the resistance to ASA among the population ranges from 5 to 45%. Resistance to ASA is primarily associated with genetic factors: the presence of polymorphisms of genes encoding platelet receptor proteins, and the functional activity of soluble guanylate cyclase (rCC), the synthesis of which is controlled by the GUCY1A3 gene. Studies have shown a link between the GUCY1A3 gene and the risk of coronary heart disease and its complications. The presence of polymorphism in the GUCY1A3 gene significantly worsens the activity of rCC, causing vasoconstriction and increased platelet aggregation. At the same time, acetylsalicylic acid cannot provide effective prevention of thrombotic and thromboembolic complications.

Eligibility criteria: Inclusion Criteria:

* Stable ischemic disease 2- 4
* CABG

Exclusion Criteria:

* the need to take any anticoagulants
* thrombocytopenia
* allergy to aspirin.

Primary outcomes:
measure: myocardial infarction, acute cerebrovascular accident, death from cardiovascular causes.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk research institute of circulation pathology
state: Novosibirskaya Oblast'
city: Novosibirsk
country: Russian Federation
facility: Aleksey
Study officials:
References:
Clinical trial NCT05920200: Factors Influencing the Results of Treatment in Patients With Hernias of Various Localizations
Official title: Factors Affecting the Results of Treatment of Patients With Hernias of Various Localization: Evaluation of Treatment Results Using an Automated Hernia Register
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inguinal Hernia
Femoral Hernia
Umbilical Hernia
Ventral Hernia
Chronic Pain
Acute Post Operative Pain
Recrrence Rate
Keywords: hernia
register
inguinal hernia
femoral hernia
umbilical hernia
ventral hernia
CPIP
postoperative complications
chronic post-operative pain
recurrence rate
Lead sponsor: Immanuel Kant Baltic Federal University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 4000
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: An unselected, consecutive regionwide cohort during 3 years, with a 3-year follow-up

Brief summary: The study attempts to quantify the relative risks for acute postoperative pain, complications rate, chronic postoperative pain (CPIP) and recurrence rate after different methods of repair of groin, umbilical and incisional hernia depending on surgical technique, mesh type and fixation suture material.

For this purpose the investigators will analyze data from the Kalinigrad Hernia Registry (KHR).


Eligibility criteria: Inclusion Criteria:

* All mesh and non-mesh repairs that have been registered in the KHR from January 9, 2020, until December 31, 2023.

Exclusion Criteria:

* Patients not having a 11-digit state-assigned Personal insurance policy number.
* Parastomal hernia;
* infected hernias;

Primary outcomes:
measure: Chronic postoperative pain rate and severity
timeFrame: 1 year
measure: Recurrence rate
timeFrame: 3 year
Secondary outcomes:
measure: Treatment satisfaction rate
timeFrame: 3 year
Other outcomes:
Locations:
city: Kaliningrad
country: Russian Federation
facility: Baltic Federal University
state: Kaliningrad Region
Study officials:
References:
Clinical trial NCT05569200: The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System
Official title: The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Uterine Tumor
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 10
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Uterine benign tumor including myoma is the most common female benign pelvic tumor. Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) has been considered to be a minimal invasive treatment. The device used in this trial will be Haifu Focused Ultrasound tumor therapeutic System. In this trial, the investigators will observe the possibility of complication and tumor response of treatment.


Eligibility criteria: Inclusion Criteria:

1. Benign uterine fibroids.
2. Women over the age of 20.
3. Abdominal circumference \<100 cm.
4. The largest fibroids are ≥ 4 cm.

Exclusion Criteria:

1. Pregnant women or those with positive pregnancy test results.
2. Those with other pelvic diseases.
3. Those with immune diseases.
4. There are unsuitable interfaces in the ultrasonic treatment path.
5. Those with tumor calcification.
6. People with severe heart, blood vessel and kidney disease.
7. Those with abnormal coagulation function and low platelets.
8. Type III fibroids according to Funaki classification

Primary outcomes:
measure: Evaluation of tumour response
timeFrame: 3 month after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT02655900: Use of 3D Ultrasound to Predict Anal Sphincter Defects
Official title: Use of 3D Ultrasound to Predict Anal Sphincter Defects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetric Anal Sphincter Injury
Keywords: Obstetric anal sphincter injury,
Ultrasound diagnosis
Lead sponsor: Croydon University Hospital
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women sustained anal sphincter injury during childbirth being followed up ante or postpartum

Brief summary: Injury to the muscles of the back passage (anal canal) is a relatively common problem. This injury can result in problems with bowel control later in life and usually occurs during vaginal childbirth (commonly referred to as 3rd and 4th degree perineal tears). Currently women who have sustained injury to the muscles of the back passage undergo an ultrasound scan by inserting a probe 3 to 4 cms into the back passage. This helps to check if the muscle of the back passage has healed i.e is intact or has a defect. The investigators would like to establish whether a 3D ultrasound scan probe placed outside the vagina can identify the defects and hence avoid inserting the probe into the back passage. In addition to getting the above information using 3D ultrasound scan, the investigators would also like to identify injuries to the pelvic floor muscle (levator ani) in these patients. Which can be diagnosed using the 3D ultrasound probe placed outside the vagina (perineum). Women who sustain injury to this muscle are known to develop prolapse later on in life.


Eligibility criteria: Inclusion Criteria:

* Women who sustained an obstetric anal sphincter injury referred to the perineal clinic

Exclusion Criteria:

* None

Primary outcomes:
measure: Diagnostic test accuracy of 3D endovaginal (EVUS) and transperineal ultrasound (TPUS) for diagnosing Obstetric Anal Sphincter injurieS (OASIS)
timeFrame: 3 months Postpartum
Secondary outcomes:
measure: Prevalence of Levator Ani Muscle Injury in women who sustained Obstetric Anal Sphincter Injury
timeFrame: 3 months Postpartum
Other outcomes:
Locations:
Study officials:
References:
citation: Taithongchai A, van Gruting IMA, Volloyhaug I, Arendsen LP, Sultan AH, Thakar R. Comparing the diagnostic accuracy of 3 ultrasound modalities for diagnosing obstetric anal sphincter injuries. Am J Obstet Gynecol. 2019 Aug;221(2):134.e1-134.e9. doi: 10.1016/j.ajog.2019.04.009. Epub 2019 Apr 11.
Clinical trial NCT00949000: AnalyST Treadmill Study
Official title: Clinical Evaluation of ST Segment Deviation Detection by SJM AnalyST and Analyst Accel Implantable Cardiac Defibrillators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-07-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to collect information on the naturally occurring variations in ST deviations at different heart rates, as detected by the AnalyST and AnalyST Accel Implantable Cardioverter Defibrillators (ICD).


Eligibility criteria: Inclusion Criteria:

* Patient has received or is scheduled to receive a St Jude Medical AnalyST or AnalyST Accel ICD;
* Patient has documented ischemic heart disease.

Exclusion Criteria:

* Patient has an indication for ventricular pacing;
* Patient has chronotropic incompetence or insufficiency;
* Patient has a contraindication to stress testing;
* Patient is physically unable to complete the stress test protocol;
* The patient has persistent or permanent atrial fibrillation (AF);
* Patient is unable to comply with the protocol and follow-up schedule based on geographic location or for any reason;
* Patient is pregnant;
* Patient is minor (\< 18 years old).

Primary outcomes:
measure: Evaluation of start and duration of isoelectric PR intervals
timeFrame: 4 weeks
measure: Evaluation of start and duration of ST intervals
timeFrame: 4 weeks
measure: Evaluation of ST segment deviations during stress testing across the 4 heart rate zones defined by the device
timeFrame: 4 weeks
measure: Incidence of ischemic events detected based on the external ECG
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Coburg
country: Germany
facility: Klinikum Coburg
state: Bavaria
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
state: Hesse
city: Aachen
country: Germany
facility: Medizinische Einrichtungen der RWTH Aachen
state: N. Rhin
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein
state: N. Rhin
city: Luedenscheid
country: Germany
facility: Klinikum Luedenscheid
state: N. Rhin
Study officials:
affiliation: Kerckhoff-Klinik, Bad Nauheim, Germany
name: Christian Hamm, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05675852: Evaluation of Visual Parameters by Visual Evoked Potentials Captured by EEG
Official title: Evaluation of Visual Parameters in Healthy and Visually Impaired Adults Using the Sweep and Oddball Technique Associated With Visual Evoked Potentials Captured by EEG
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Visual Neurosciences
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy participants to better understand visual neurosciences.

Brief summary: This project will be based on an approach that has already proven itself in the field of the development of low-level visual functions such as visual acuity, vernier acuity and contrast sensitivity (Norcia \& Tyler, 1985): scanning visual evoked potentials" (sVEP), a special case of steady-state visual evoked potentials (SSVEP). While SSVEPs consist of presenting a visual stimulus periodically, sVEPs are SSVEPs where the value of a parameter (e.g. the contrast of the stimulus) varies. This variation ("scanning") makes it possible to determine the threshold value where an electroencephalographic (EEG) response is perceived, and thus to evaluate visual parameters such as visual acuity, vernier acuity and contrast sensitivity. In this study we therefore record the amplitude of the EEG electrical signal during the presentation of low-level stimuli such as spatial frequency gratings or increasing or decreasing contrast.


Eligibility criteria: Inclusion Criteria:

* Absence of ocular pathologies except for refractive errors
* Absence of neurologic conditions

Exclusion Criteria:

* Participants using neurologic or psychiatric drugs
* Scalp pathology

Primary outcomes:
measure: Threshold of visual recognition of low and high grade visual stimuli
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Woluwe-Saint-Lambert
country: Belgium
facility: Institute Of NeuroSciences
state: Bruxelles
Study officials:
References:
Clinical trial NCT02346552: Usability and Performance Evaluation of the AutoLap System - a Feasibility Study
Official title: Usability and Performance Evaluation of the AutoLap System - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Laparoscopic Surgery Candidate
Bariatric Laparoscopic Surgery Candidate
Keywords: laparoscopic Cholecystectomy
laparoscope holder
Nissen fundoplication
paraesophageal hernia
sleeve surgery
Lead sponsor: M.S.T. Medical Surgery Technology LTD.
Sponsor class: INDUSTRY
First posted: 2015-01-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main objectives of this study are to evaluate the ease of use and performance of the AutoLap system compared to human camera holder during general and bariatric laparoscopic surgeries.


Eligibility criteria: Inclusion Criteria:

1. Signed and dated Informed Consent Form (ICF).
2. Patients over 18 years who were scheduled for elective laparoscopic Cholecystectomy, Nissen fundoplication, paraesophageal hernia and sleeve surgery procedures

Exclusion Criteria:

1. Extensive adhesions that will preclude routine laparoscopic surgical approach.
2. Pregnancy
3. Patient participates in any other clinical study 60 days prior to the start of the study and throughout the study duration.

Primary outcomes:
measure: Image stability
timeFrame: during surgery, an expected average of 1 hour
measure: Usability
timeFrame: post surgery, an expected average of 3 minutes
Secondary outcomes:
measure: System set-up time
timeFrame: during surgery, an expected average of 5 minutes
measure: Length of surgery
timeFrame: during surgery, an expected average of 1 hour
measure: The Number of times that the laparoscope was removed for cleaning
timeFrame: during surgery, an expected average of 1 hour
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
Study officials:
affiliation: Lahey Hospital & Medical Center
name: Dmitry Nepomnayshy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06797752: Effect of the Stellate Ganglion Block on the Retinal Microcirculation
Official title: Effect of the Stellate Ganglion Block on the Retinal Microcirculation: A Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: OCTA
Severe Brain Injury
Subarachnoid Hemorrhage
Intracerebral Hemorrhage
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving the stellate ganglion block

Brief summary: Surges in the sympathetic nervous system occur at the ictus of a variety of neurological critical illnesses including intracranial hemorrhage and ischemic stroke. It is hypothesized that these exaggerated increases in sympathetic nervous activity produce maladaptations that promote secondary brain injury. One of these possible mechanisms include diffuse vasospasm that cause cerebral ischemia. Hence, methods to abrogate the sympathetic nervous system in this context are under active investigation. One possible method is the regional anesthesia technique of the stellate ganglion nerve block, which is ordinarily used for complex regional pain syndrome, but has been shown to reduce cerebral sympathetic activity and reduces vasospasm in patients with subarachnoid hemorrhage. However, its effect on the microcirculation is not clear. Hence, we propose to study patients receiving the stellate ganglion nerve block as part of their standard medical care and to image their retinal microcirculation before and after the procedure using Optical Coherence Tomography Angiography (OCTA).


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Patients receiving the stellate ganglion nerve block for an approved indication, e.g. complex regional pain syndrome

Exclusion Criteria:

* Pregnancy
* Non-English speaking
* Temporary or permanent physical limitation that renders the patient unable to sit up and look inside OCTA device

Primary outcomes:
measure: Vascular and Perfusion Density
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Noah Jouett, DO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patton N, Aslam T, Macgillivray T, Pattie A, Deary IJ, Dhillon B. Retinal vascular image analysis as a potential screening tool for cerebrovascular disease: a rationale based on homology between cerebral and retinal microvasculatures. J Anat. 2005 Apr;206(4):319-48. doi: 10.1111/j.1469-7580.2005.00395.x.