louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00894621: Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation
Official title: Norepinephrine as Early Vasopressor Therapy in Children Undergoing Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Shock
Mechanical Ventilation
Keywords: Shock
Respiration, artificial
Norepinephrine
Lead sponsor: Unidade de Terapia Intensiva
Sponsor class: OTHER
First posted: 2009-05-07
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness from early infusion of norepinephrine in pediatric patients submitted to mechanical ventilation for the use of sedative and analgesics drugs.


Eligibility criteria: Inclusion Criteria:

* Children, who, in the arrival or during the admission in pediatric intensive care unit, develop the need for mechanical ventilation and continuous infusion of sedatives and/or analgesics

Exclusion Criteria:

* Patients after cardiac arrest
* Patients with tracheostomy
* Patients with renal and/or hepatic failure
* Patients with previous episode of cardiac arrythmia
* Patients with mechanical ventilation forecast lesser that four days

Primary outcomes:
measure: To compare norepinephrine and placebo as initial therapy in pediatric patients submitted to the mechanical ventilation with reference to hemodynamic parameters, diuresis and diuretics' use.
timeFrame: 5 days
Secondary outcomes:
measure: To assess possible side effects related with the early norepinephrine infusion.
timeFrame: 5 days
Other outcomes:
Locations:
city: Caxias do Sul
country: Brazil
facility: Hospital Geral
state: Rio Grande do Sul
Study officials:
References:
citation: Piva J, Alquati T, Garcia PC, Fiori H, Einloft P, Bruno F. Norepinephrine infusion increases urine output in children under sedative and analgesic infusion. Rev Assoc Med Bras (1992). 2014 May-Jun;60(3):208-15. doi: 10.1590/1806-9282.60.03.008.
Clinical trial NCT02991521: A Study to Improve the FAST Ultrasound Exam
Official title: Can we be FASTeR? A Multicenter Study Utilizing Right Sided Roll to Improve Sensitivity of the FAST Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemoperitoneum
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 182
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: This research study aims to improve the standard exam called Focused Assessment with Sonography in Trauma (FAST). The FAST exam is an ultrasound test used to identify an abdominal bleed. The study will see if having patients roll on their right side improves the FAST exam. Making the FAST exam better can help trauma doctors save the lives of patients with bleeding.


Eligibility criteria: Inclusion Criteria:

* All trauma patients who present as a Trauma Activation with clinical history or physical signs of blunt abdominal trauma.

Exclusion Criteria:

* Pregnant females
* Prisoners
* Patients with prohibitive right sided chest trauma
* Patients in extremis undergoing salvage maneuvers (chest compressions or emergent surgical intervention) which prevents performance of an ultrasound examination
* Patient who leave against medical advice or are otherwise removed from the medical system before their work up has been completed

Primary outcomes:
measure: Number of Subjects Screening Positive for Blood Around the Abdominal Organs (Hemoperitoneum) After Trauma, as Assessed by Focused Assessment With Sonography for Trauma (FAST), a Rapid Bedside Ultrasound Examination.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
city: Sayre
country: United States
facility: The Guthrie Clinic
state: Pennsylvania
Study officials:
name: Danielle Pigneri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cibulas Shumway M, Granet J, Solomon RJ, Parreco JP, Lee SK, Pigneri DA; FASTeR Study Group. Using Right-Sided Roll to Improve Reliability of Focused Assessment with Sonography in Trauma: An Eastern Association for the Surgery of Trauma Multicenter Prospective Study. J Am Coll Surg. 2023 Jan 1;236(1):99-104. doi: 10.1097/XCS.0000000000000443. Epub 2022 Dec 15.
Clinical trial NCT04807621: Platelets or Fibrinogen as First-line Treatment for Bleeding During Pedatric Heart Surgery
Official title: Platelets or Fibrinogen as First-line Treatment for Bleeding During Pedatric Heart Surgery: a Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Congenital Heart Disease
Keywords: Bleeding
Coagulopathy
Heart surgery
Cardiopulmonary bypass
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 40
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to test whether platelet transfusion or fibrinogen concentrate is the most effective treatment of intraoperative bleeding, when performing open heart surgery with cardiopulmonary bypass on children with congenital heart defects.


Eligibility criteria: Inclusion Criteria:

* Children \< 1 years of age, scheduled for open surgery of congenital heart defects, using cardiopulmonary bypass.
* Body weight \< 10 kg.
* Expected CPB time \> 90 minutes.

Exclusion Criteria:

* Known coagulation disorder, current treatment with antiplatelet and/or anticoagulant drugs, major surgery the past month before the planned surgery, preoperative kidney or liver failure (defined as creatinine and/or transaminases \> normal interval for the patient´s age), gestational age \< 34 weeks.

Primary outcomes:
measure: HEPTEM-A10
timeFrame: 45 minutes after intervention
Secondary outcomes:
measure: Amount of transfused packed red blood cells
timeFrame: up to first postoperative morning
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References:
Clinical trial NCT03187002: Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion
Official title: Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion: A Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion in First Trimester
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High-frequency, high-intensity transcutaneous electrical nerve-stimulation (TENS) is an inexpensive and non-invasive pain control approach. TENS, pulsating electrical currents that activate underlying nerves, does not have drug interactions or risk of overdose. Cochrane review of TENS for acute pain found inconclusive evidence. One previous abortion trial comparing TENS to IV sedation only looked at pain control in the recovery room. The investigators propose a randomized controlled trial comparing TENS to IV sedation (in conjunction with local anesthesia) among women presenting for first-trimester surgical abortion. Primary outcome will be perceived pain by Visual Analogue Scale (VAS) during aspiration.


Eligibility criteria: Inclusion criteria:

* Presenting for surgical abortion
* Gestational age \<12 weeks
* \< 18 years of age
* Agrees to be randomized

Exclusion criteria:

* Allergy to study medications (lidocaine, fentanyl, midazolam)
* \> 18 years of age
* Fetal demise
* Pre-procedure use of misoprostol
* No means of transportation following procedure

Primary outcomes:
measure: Aspiration Pain
timeFrame: Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds)
Secondary outcomes:
measure: Speculum Placement Pain
timeFrame: Intraoperative, collected during procedure (up to 30 seconds)
measure: Tenaculum Placement Pain
timeFrame: Intraoperative, collected during procedure (up to 30 seconds)
measure: Paracervical Block Pain
timeFrame: Intraoperative, collected during procedure (up to 30 seconds)
measure: Manual Cervical Dilation Pain
timeFrame: Intraoperative, collected during procedure (up to 30 seconds)
measure: Speculum Removal Pain
timeFrame: Intraoperative, collected during procedure (up to 30 seconds)
measure: Total Procedure Time
timeFrame: Intraoperative, collected during procedure (up to 20 minutes)
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Planned Parenthood Mar Monte
state: California
Study officials:
affiliation: Stanford University
name: Principal Investigator, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lerma K, Goldthwaite LM, Blumenthal PD, Shaw KA. Transcutaneous Electrical Nerve Stimulation for Pain Management of Aspiration Abortion up to 83 Days of Gestation: A Randomized Controlled Trial. Obstet Gynecol. 2021 Sep 1;138(3):417-425. doi: 10.1097/AOG.0000000000004502.
Clinical trial NCT05859321: Virtual Reality Based Physical Therapy for Patients With Lower Back Pain
Official title: Effects of Virtual Reality on Pain, Functional Disability and Fear Avoidance Belief in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: low back pain
chronic low back pain
virtual reality
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 84
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare chronic low back patients. The main question\[s\] it aims to answer are:

* pain and disability
* fear avoidance belief Participants will perform virtual reality exercises
* virtual reality based exercises
* Routine Physical Therapy To Compare routine physical therapy treatment in addition to virtual reality to see effects on pain, functional disability and fear avoidance belief


Eligibility criteria: Inclusion Criteria:

* Low back pain that persists for more than 12 weeks
* Non-radiating low back pain
* Mechanical low back pain
* Both Gender

Exclusion Criteria:

* trauma or fracture of the spine
* any cardiac disease
* any systematic disease
* history of any neurological diseases such as Parkinson's disease, stroke and epilepsy
* patient on corticosteroid or anticoagulants
* history of any Drug abuse
* any Congenital deformity
* Virtual reality games phobia
* Pregnant female

Primary outcomes:
measure: Pain Intensity
timeFrame: at baseline
measure: Functional disability
timeFrame: at baseline
measure: Pain Intensity
timeFrame: at 4th week
measure: Pain intensity
timeFrame: at 8th week
measure: Functional Disability
timeFrame: 4th week
measure: Functional Disability
timeFrame: 8th week
Secondary outcomes:
measure: Fear avoidance belief
timeFrame: at baseline
measure: Range of motion
timeFrame: Change in range of motion score will be measured at baseline, at 8th week
measure: Fear avoidance belief
timeFrame: 4th week
measure: Fear avoidance belief
timeFrame: 8th week
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Lahore
state: Punjab
Study officials:
References:
Clinical trial NCT05978921: Physical Exercise in Patients With Schizophrenia
Official title: Effect of Physical Strength Exercise on Telomeric Length as a Marker of Aging and Early Death in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia
Physical Activity
Telomere Shortening
Premature Aging
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Randomised clinical trial on a cohort of subjects with a diagnosis of schizophrenia of legal age, of both sexes, recruited in the mental health clinics of the Salamanca University Assistance Complex and who will be randomly distributed into two groups (intervention and control).

The main objective of the study is to determine the effect of physical exercise on telomere size in patients diagnosed with schizophrenia.

As secondary objectives in this group of patients we will try to:

Evaluate the influence of strength training on cognition and negative symptoms of schizophrenia.

To quantify the impact of strength training on frailty. To determine the effect of strength training on quality of life. To study the possible correlation between physical parameters (frailty) and telomere length.

To establish the importance of polymorphisms in telomerase genes, an enzyme involved in the maintenance of telomere length.


Eligibility criteria: Inclusion Criteria:

* be at least 18 years of age
* have been diagnosed with schizophrenia for at least 5 years

Exclusion Criteria:

* are unable to read and understand the patient information sheet and sign the informed consent form.

Primary outcomes:
measure: Telomere Length
timeFrame: Baseline and immediately after the intervention
Secondary outcomes:
measure: Date of birth
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
measure: Heighth
timeFrame: Baseline
measure: Negative Symptoms
timeFrame: Baseline and immediately after the intervention
measure: Fragility
timeFrame: Baseline and immediately after the intervention
measure: Cognition
timeFrame: Baseline and immediately after the intervention
measure: Quality of life
timeFrame: Baseline and immediately after the intervention
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Universidad de Salamanca
state: Castilla Y León / Salamanca
Study officials:
References:
Clinical trial NCT05300321: DIMS-myopia Progression ADN Axial Length Growth
Official title: Efficacy of Defocus Incorporated Multiple Segments (DIMS) Lens Chinese Myopic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia, Progressive
Keywords: myopia
axial length
DIMS
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 82
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To confirm the efficacy of DIMS lenses in controlling myopia progression, we planned a prospective randomized controlled clinical study.

Detailed description: The subjects were randomly assigned into two groups: the control group (SV) and the experimental group (DIMS). The clinical trial assistant took the glasses before examination and returned them after examiners had performed all tests. Examiners were unaware of the spectacle type until the end of the follow-up period. However, the lens type was known by children and parents since the unique appearance of the DIMS lens.

The subjects were provided details about the study design and methodology and their rights as subjects at first visit. We conducted visual acuity tests, subjective and objective refraction measurements, AL measurements, heterophoria at distance and near, and accommodation after obtaining written informed consent from them and their parent.

We conducted follow-up examinations 6 and 12 months after the first visit. In the follow-up examinations, we measured all the examination as do ate the firt visit.

Either the VA with the current spectacles dropped to \< 0.8(20/20) or SE of cycloplegic subjective refraction increased ≤-0.50D, the lens power of the spectacles was replaced on the basis of the cycloplegic subjective refraction.

Eligibility criteria: Inclusion Criteria:

* The subjects had spherical RE of -1.00 to -6.50 D, astigmatism ≤ 4.00 D, anisometropia ≤ 1.50 D
* Best corrected visual acuity (BCVA) equal to or better than logMAR 0.0 (20/20) in both eyes.

Exclusion Criteria:

* Candidate subjects were excluded from the study if they had strabismus, ocular limitations, or systemic abnormalities affecting vision and ocular motility.

Primary outcomes:
measure: Cycloplegic objective refraction
timeFrame: 12months
Secondary outcomes:
measure: Axial Length
timeFrame: 12months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
Study officials:
affiliation: Tianjin Eye Hospital
name: Xiaoqin Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03653221: Developing of Virtual Reality Based Neurologic Examination Teaching Tool(VRNET)
Official title: Developing of Virtual Reality Based Neurologic Examination Teaching Tool(VRNET)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Students
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 95
Sex: ALL
Minimum age (years): 23
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 1. standardized patients with VRNET
2. standardized patients
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the effect of the virtual reality based neurologic examination teaching tool(VRNET) for medical students. VRNET is a new teaching tool for neurologic examinations by offering different neurologic signs of the face, with which medical students can experience more realistic patients.


Eligibility criteria: Inclusion Criteria:

* 4th grade medical students of emergency medicine clerkship who agree with participation on this study.

Exclusion Criteria:

* Disagree with participation on this study.
* Who are absent the last day of clerkship.

Primary outcomes:
measure: Neurologic physical exam(NPE) score
timeFrame: after 2 weeks clinical clerkship rotation.
Secondary outcomes:
measure: Satisfaction of students for VRNET
timeFrame: after 2 weeks clinical clerkship rotation.
measure: Reality of VRNET by students
timeFrame: after 2 weeks clinical clerkship rotation.
measure: Evaluation of students by standardized patients
timeFrame: after 2 weeks clinical clerkship rotation.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of emergency medicine, Yonsei University College of Medicine, Seoul, Korea
Study officials:
References:
Clinical trial NCT02554721: Pharmacodynamic Study of Cilostazol in Healthy Volunteers
Official title: Effect of Cilostazol as an add-on Treatment to a Single Antiplatelet Agent (Acetylsalicylic Acid or Clopidogrel) on Platelet Function Testing and Bleeding Time in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 77
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to investigate the effects of Cilostazol, Acetylsalycylic acid and Clopidogrel alone as well as combinations of Cilostazol/Acetylsalicylic acid and Cilostazol/ Clopidogrel on ex-vivo Platelet Function (PF) testing.


Eligibility criteria: Inclusion Criteria:

* Healthy Caucasian male subjects
* Able to read, to write and to fully understand German language
* Provision of written informed consent before screening and baseline
* BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
* Good general health as determined by the investigator by medical history, physical examination, vital signs, electrocardiogram, baseline and safety lab

Exclusion Criteria:

* Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms
* Known predisposition to bleeding (e.g. active peptic ulceration, recent (within 6 month) haemorrhagic stroke, proliferative diabetic retinopathy, poorly controlled hypertension)
* Use of antibiotics within thirty (30) days prior to screening and until baseline visit
* Clinically significant abnormalities in medical history, physical examination, vital signs, electrocardiogram, baseline and safety lab
* Supine pulse rate \> 100 beats/min or \<50 beats/min
* Systolic blood pressure \<100 or \>140 mmHg
* Diastolic blood pressure \<50 or \>90 mmHg
* Concomitant use of any other medication including over-the-counter preparations

Primary outcomes:
measure: Ex-vivo Inhibition Of Platelet Aggregation (IPA)
timeFrame: Baseline, Visit 5 (Day 22-29)
Secondary outcomes:
measure: Effects On Skin Bleeding Time (BT)
timeFrame: Visit 5 (Day 22-29)
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Osamu Sato
role: STUDY_DIRECTOR
References:
Clinical trial NCT05243121: Artificial Intelligence Analysis for Magnetic Resonance Imaging in Screening and Diagnosis of Breast Cancer
Official title: Peking University People's Hospital Radiology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasms
Magnetic Resonance Imaging
Keywords: breast neoplasms
magnetic resonance imaging
screening
deep learning
machine learning
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 5000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinically symptomatic patients (defined as palpable masses, nipple discharge, asymmetric thickening or nodules, and abnormal skin changes according to the guidelines) should be examined by BMRI at the judgment of the clinician.

Brief summary: Use Convolutional Neural Networks Analysis for Classification of Contrast-enhancing Lesions at Multiparametric Breast MRI. Build an abbreviated protocal, and investigate whether an abbreviated protocol was suitable for breast magnetic resonance imaging screening for breast mass in Chinese women, which can shorten the examination time and avoid enhanced imaging while ensuring the accuracy of the diagnosis.


Eligibility criteria: Inclusion Criteria:

* Patients with clinical symptoms (define as palpable mass, nipple discharge, asymmetric thickening or nodules, and abnormal skin changes)
* Patients undergoing full sequence BMRI examination
* Through the follow-up database, at least 6 months of follow-up results can be obtained to determine whether the diagnosis result is negative/benign/malignant; for patients who need pathological biopsy, the pathological biopsy results shall prevail to determine the lesion benign/malignant

Exclusion Criteria:

* The breast had received radiotherapy, chemotherapy, biology and other treatments before BMRI.
* There are contraindications for breast-enhanced MRI examinations such as allergy to contrast agents.
* A prosthesis is implanted in the affected breast.
* Patients during lactation or pregnancy

Primary outcomes:
measure: Breast Cancer Screening
timeFrame: 5 years
Secondary outcomes:
measure: The accuracy of radiologists and deep learning models
timeFrame: 5 years
measure: Health economics
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university people's hospital
state: Beijing
Study officials:
References: