louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06658496: PDA for Kidneys Study
Official title: Development of a Novel Kidney-focused Approach to Treatment of a Patent Ductus Arteriosus (PDA) in Vulnerable Preterm Neonates - A Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patent Ductus Arteriosus
Congenital Heart Disease
Keywords: neonate
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2024-10-26
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates born \<32 weeks gestational age (GA) at Meriter Hospital, Inc. and outborn neonates admitted to Meriter Hospital, Inc. within 12 hours of life.

Brief summary: The goal of this observational study is to gather more information on kidney oxygen levels in babies with a patent ductus arteriosus (PDA), and evaluate the relationships between kidney oxygen levels, PDA status and kidney injury.

Researchers will do this by looking at ultrasound images of the heart, analyzing substances in the urine, and evaluating oxygen levels in the kidneys.


Eligibility criteria: Inclusion Criteria:

* Delivered at \<32 weeks' gestation
* ≤72 hours of age
* Inpatient at Meriter Hospital, Inc. NICU
* At least one parent/guardian is able to provide parental permission in English or Spanish

Exclusion Criteria:

* Major congenital anomalies of kidney
* Attending physician's discretion to not place NIRS sensors due to clinical concerns
* In the PI or Co-I's medical opinion, there is a significant likelihood that the neonate would not survive the first 3 days of life
* Birth parent aged \<18

Primary outcomes:
measure: Comparison of patent ductus arteriosus (PDA) echocardiography parameters to kidney hypoxia
timeFrame: Days 1 to 7 of age
Secondary outcomes:
measure: Correlation of Iowa PDA score to kidney hypoxia
timeFrame: Days 1-7 of age
measure: Correlation between urinary biomarkers and Iowa PDA score
timeFrame: Days 1-7 of life
measure: Correlation between rates of hypertension and Iowa PDA score
timeFrame: Duration of hospitalization, up to 6 months
measure: Correlation between rates of acute kidney injury (AKI) and Iowa PDA score
timeFrame: Duration of hospitalization, up to 6 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: Meriter Hospital, Inc.
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Matthew Harer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06423196: Upper Limb Blood Flow Restriction in Handball Players
Official title: Efficacy of Upper Limb Blood Flow Restriction in Handball Players. Randomised Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Keywords: Handball
Blood flow restriction
Muscle strength
Muscle activation
Upper limbs
Physiotherapy
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Introduction. Blood flow restriction therapy involves the use of an occlusion cuff placed over an extremity resulting in a partial reduction of arterial blood flow and total restriction of venous return.

Objectives. To analyse the efficacy of a physiotherapy intervention using blood flow restriction in improving upper limb strength in adult handball players.

Methods. Randomised, single-blind, clinical study. 20 athletes will be recruited and randomly assigned to the experimental and control groups. The intervention of the experimental group will consist of performing an exercise protocol after blood flow restriction. The intervention period will last 4 weeks, with a periodicity of 2 weekly sessions of 30 minutes each. The primary variable will be the strength of the triceps, epicondyle and epitrochlear musculature (pressure hand dynamometer). The secondary variable will be the muscle activation of this musculature (surface electromyography).


Eligibility criteria: Inclusion Criteria:

* Athletes over 18 years of age.
* Federated in handball at the time of the study.
* No lower limb injuries in the three months prior to the study.
* Signing the informed consent document.

Exclusion Criteria:

* Athletes who have undergone surgery in the year prior to the study.
* People who do not attend at least 80% of the treatment sessions.
* Players who are receiving physiotherapy treatment in parallel to the physical preparation of the team they are playing for.

Primary outcomes:
measure: Assess the muscle strength at screening visit
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up
Secondary outcomes:
measure: Assess the muscle activation at screening visit
timeFrame: Screening visit, within the first seven days after treatment and after four weeks follow-up
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Católica San Antonio, Murcia
Study officials:
References:
Clinical trial NCT04518735: Evolution of COVID-19 in Anticoagulated or Antiaggregated Patients (CORONA Study)
Official title: Evolution of COVID-19 in Anticoagulated or Antiaggregated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Covid19
Oral anticoagulant
VKA
DOAC
Antiplatelet therapy
Heparin
Low molecular-weight heparin
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 1707
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of any age and sex, suffering from Covid19 needing hospital admission more than 1 day for treatment and/or supportive care

Brief summary: CORONA is a retrospective, observational, one center study to investigate the clinical evolution (in terms of survival and thromboembolic complications) of patients on chronic treatment with anticoagulants or antiplatelet agents who are admitted to the hospital for COVID-19 compared with patients who do not receive anticoagulants or antiplatelet agents.


Eligibility criteria: Inclusion Criteria:

* Patient admitted for COVID-19 at the Hospital de la Santa Creu i Sant Pau,
* Positive COVID-19 polymerase chain reaction test
* Length of stay more than 24 hours

Exclusion Criteria:

* No objective diagnose for COVID-19
* Outpatient
* Lenght of stay less than 24hours

Primary outcomes:
measure: Mortality
timeFrame: From hospital admission to day 28
measure: Transfer to the Intensive Care Unit (ICU)
timeFrame: From hospital admission to day 28
Secondary outcomes:
measure: Thromboembolic complications
timeFrame: From hospital admission to day 28
measure: Major bleeding complications
timeFrame: From hospital admission to day 28
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalonia
Study officials:
References:
Clinical trial NCT02391558: Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography
Official title: Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with clinical indication for fluorescein angiography will be invited to perform OCT angiography in the same day during a period of 6-8 months.

Brief summary: Clinical evaluation of noninvasive OCT Angiography using a Zeiss OCT Prototype to replace fluorescein angiography.

Detailed description: Fluorescein angiography (FA) is the standard and generally accepted method to identify vascular features in the retina, detecting capillary dropout and neovessel growth. Its value is undeniable and is a routine ophthalmological examination. However, it requires intravenous injection of fluorescein, which can cause nausea, vomiting and, rarely, anaphylaxis and death. New OCT angiography methods can detect, noninvasively red blood cells flow and, therefore, identify well the retinal vasculature. It is crucial and of major interest to evaluate the clinical utility of this new methodology comparing this information with the one obtained from fluorescein angiography.

Eligibility criteria: Inclusion Criteria:

* All patients with clinical indication for fluorescein angiography in their clinical practice

Exclusion Criteria:

* Subjects with a pacemaker of similarly critical electronic device
* Subjects with severe ocular media opacities
* Subjects with corneal abnormalities

Primary outcomes:
measure: Comparison between examination techniques on the detection of morphological changes in the retina (such as vessels morphology, vascular ischemia, retinal neovascularization, choroidal neovascularization, and other vascular abnormalities).
timeFrame: Single Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Aibili - Cec
Study officials:
References:
citation: Soares M, Neves C, Marques IP, Pires I, Schwartz C, Costa MA, Santos T, Durbin M, Cunha-Vaz J. Comparison of diabetic retinopathy classification using fluorescein angiography and optical coherence tomography angiography. Br J Ophthalmol. 2017 Jan;101(1):62-68. doi: 10.1136/bjophthalmol-2016-309424. Epub 2016 Dec 7.
Clinical trial NCT00949858: New Data Analysis Methods for Actigraphy in Sleep Medicine
Official title: New Data Analysis Methods for Actigraphy in Sleep Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Restless Leg Syndrome
Insomnia
Keywords: Sleep Disorders
Obstructive Sleep Apnea
Restless Leg Syndrome
Insomnia
Actigraphy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Utah State University
First posted: 2009-07-30
Enrollment: 635
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen in clinic at the Washington University Sleep Medicine Center.

Brief summary: The purpose of this study is to develop statistical and informatics tools for analyzing and visualizing Actical™ (actigraphy) data linked to fatigue in Sleep Medicine Center patients.

Detailed description: An Actical™ is a watch-like device attached to the wrist that uses an accelerometer to measure movement nearly continuously over several days. The American Academy of Sleep Medicine practice parameters report that actigraphy is a useful tool for detecting sleep in healthy individuals, assessing specific aspects in insomnia and restless legs syndrome, circadian-rhythm disorders, and excessive sleepiness. Concurrent with these recommendations is an increased interest in the use of actigraphy as a tool for objectively measuring fatigue. With improved high-end statistical methods for analyzing this data, actigraphy has the potential to become more important as an objective diagnostic tool for determining fatigue, sleep abnormalities and assessing response to treatment.

Eligibility criteria: Inclusion Criteria:

* Patient presenting to the Washington University Sleep Medicine Center for evaluation of obstructive sleep apnea syndrome, restless legs syndrome, or insomnia
* Older than 18 years of age
* Ability to consent to participation in the study
* Willingness to wear the Actical™ for two 7 day periods and to return the equipment promptly

Exclusion Criteria:

* Inability to provide valid consent
* Pregnancy
* Night or rotating shift workers

Primary outcomes:
measure: Define an object oriented data model for actigraphy and patient level data.
timeFrame: 6 months
Secondary outcomes:
measure: Apply existing and develop new advanced statistical and visualization methods for actigraphy data and include them in the data model listed above.
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University Sleep Medicine Center
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: William Shannon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03972358: Assessing Medical Menstrual Regulation in the United States
Official title: Assessing Acceptability and Use of Medical Menstrual Regulation in the United States
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Menstrual Regulation
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 284
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the acceptability and use of medical menstrual regulation among women in the United States.

Detailed description: Medical menstrual regulation (MMR) entails the use of uterine evacuation medications by women with late menses without confirming pregnancy status. Provision of MMR in the United States could expand reproductive choice and service options for women. This study will collect data on the acceptability, efficacy, safety and feasibility of MMR among women with missed menses of 1-21 days

Eligibility criteria: Inclusion Criteria:

1. Age 18-49 years
2. General good health
3. Does not want to be pregnant
4. Does not want to verify pregnancy status at the study site
5. History of regular monthly menstrual cycles
6. Missed menses of 1-21 days
7. Sexual activity in the past 2 months
8. Willing and able to sign consent forms
9. Willing to provide urine sample at enrollment
10. Willing to return for a follow-up visit

Exclusion Criteria:

1. Known allergies or contraindications to mifepristone and/or misoprostol
2. Symptoms of or risk factors for ectopic pregnancy
3. Current use of an IUD, contraceptive implant or injectable

Primary outcomes:
measure: Number of participants who report that MMR was acceptable or highly acceptable during the exit interview
timeFrame: Up to 28 days after mifepristone administration
Secondary outcomes:
measure: Number of participants not pregnant at follow-up
timeFrame: Up to 28 days after mifepristone administration
measure: Number of participants with adverse events and/or side effects
timeFrame: Up to 28 days after mifepristone administration
measure: Perceived advantages and disadvantages of MMR as reported by participants during the exit interview
timeFrame: Up to 28 days after mifepristone administration
Other outcomes:
Locations:
city: Skokie
country: United States
facility: Carafem Health Center
state: Illinois
city: Chevy Chase
country: United States
facility: Carafem Health Center
state: Maryland
Study officials:
affiliation: Gynuity Health Projects
name: Wendy R Sheldon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04540458: 3D Maternal Fetal Bonding
Official title: Effect of 3D Ultrasounds and 3D Printed Models on Maternal and Paternal Fetal Attachment and Anxiety and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal-Fetal Relations
Paternal Behavior
Maternal Behavior
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 288
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3D ultrasound and picture of ultrasound or 3D ultrasound and printed model of fetal face
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal and paternal attachment, lower stress, anxiety and depression and have improved life-style choices during pregnancy. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby.


Eligibility criteria: Inclusion Criteria:

* Age - Female 19-45 years of age; Male \> 19 years of age
* Currently pregnant (\< 32 weeks gestation)
* Have normal 20-week ultrasound

Exclusion Criteria:

* Having received more than 3 ultrasounds prior to study
* Medical need for additional ultrasounds
* Multiple fetuses
* \> 31 weeks gestation

Primary outcomes:
measure: Maternal Antenatal Attachment Scale (MAAS)
timeFrame: 5 minutes
measure: Paternal Antenatal Attachment Scale (PAAS)
timeFrame: 5 minutes
measure: Maternal anxiety
timeFrame: 3 minutes
measure: Paternal depression
timeFrame: 3 minutes
measure: Maternal depression
timeFrame: 3 minutes
measure: Paternal anxiety
timeFrame: 3 minutes
measure: Maternal stress
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: John Cote, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03963258: Short-Term Effects of Whole-Body Vibration on Upper Extremity Function in Subjects With Poststroke Hemiplegia
Official title: Short-Term Effects of Whole-Body Vibration on Upper Extremity Function in Subjects With Poststroke Hemiplegia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rehabilitation
Stroke
Hemiplegia
Physical Therapy Modalities
Electromyography
Upper Extremity
Recovery of Function
Vibration
Keywords: Whole-Body vibration
Stroke
Hemiplegia
upper extremity
Rehabilitation training
Muscular surface EMG
Vibration training
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of whole body vibration on upper limb motor function in hemiplegic patients with subacute stroke


Eligibility criteria: Inclusion Criteria:

* After unilateral stroke 1 to 6 months
* An ischemic or hemorrhagic poststroke hemiplegia
* No cognitive impairment
* Able to reach Brunnstrom stage II or above in the proximal and distal parts of the arms
* No excessive pain in the more affected upper extremity
* All subjects agreed to participate in the study after receiving explanations regarding the purpose and procedures of the experiment, and they signed an informed consent statement before participation

Exclusion Criteria:

* Unsteadiness
* Accompanied by important organs (such as heart, liver, lung, kidney) dysfunction or malignant tumors
* Contraindications to general vibration training exist
* Combined with other diseases causing upper limb dysfunction

Primary outcomes:
measure: upper-extremity Fugl-Meyer Scale
timeFrame: After the 3-week intervention period
measure: Wolf Motor Function Test
timeFrame: After the 3-week intervention period
measure: Surface electromyography
timeFrame: After the 3-week intervention period
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Univercity Third Hospital
state: No State Or Province
Study officials:
affiliation: Peking University Third Hospital
name: mouwang zhou, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02100358: Functional MRC With Eovist for Acute Cholecystitis
Official title: Accuracy of Functional MRC With Gadoxetate Disodium in the Diagnosis of Acute Cholecystitis: Comparison With Hepatobiliary Scintigraphy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cholecystitis
Keywords: acute cholecystitis
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2014-03-31
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have recently (within 12 hours) undergone a clinically-indicated nuclear medicine hepatobiliary scan not involving sedation or anesthesia for suspected acute cholecystitis

Brief summary: Functional magnetic resonance cholangiography (fMRC) with gadoxetate disodium (Eovist) is an accurate method of diagnosing acute cholecystitis.

Detailed description: Primary Objective:

To determine the accuracy of fMRC in evaluating patients with suspected cholecystitis.

Secondary Objective:

To compare the results of fMRC with conventional hepatobiliary scintigraphy.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Symptoms of right upper quadrant pain with ambiguous US (and/or CT) findings
* Standard of care nuclear medicine hepatobiliary scan to rule out acute cholecystitis -

Exclusion Criteria:

* Scheduled for emergent surgery, or is otherwise determined by the Investigator that the subject is clinically unsuitable for the study
* Glomerular filtration rate (GFR) below 60 mL/min/1.73m2
* Total bilirubin above 3.0 mg/dL
* Inability to provide informed consent (altered or diminished mental status)
* Allergic to morphine
* Known or suspected hypersensitivity to gadolinium-based agents
* The standard MRI contraindications apply, including but not limited to: having a pacemaker or other implanted electronic device, metal foreign bodies within the eye, aneurysm clips, heart valve prosthesis, vascular stents, coils, intrauterine devices (IUDs), penile implants, inferior vena cava (IVC) filters, gunshot wounds with retained bullet fragments.
* Pregnant or breast-feeding -

Primary outcomes:
measure: Number of positive cases of acute cholecystitis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: Assistant Professor
name: Michael T Corwin, MD
role: PRINCIPAL_INVESTIGATOR
References: