louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05026788: Impact of COVID-19 Pandemic on Orthopaedic Practice
Official title: Impact of COVID-19 Pandemic on Orthopaedic Practice: the COVid-19 Emergency/Elective Related Trauma (COVERT) Collaborative
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Trauma
Orthopedic Disorder
Anesthesia
Morality
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anyone presenting with orthopaedic trauma to the Emergency Department who has been referred to the on-call Trauma and Orthopaedic team for further management.

Brief summary: The COVERT Collaborative is led by a group of academic surgeons that is looking into the impact of the unprecedented COVID-19 pandemic on Trauma and Orthopaedic practice. This will involve both trauma and elective procedures, as well as mortality rates, operative and anaesthetic case mix. The information will help to shape service reconfiguration and enhance patient-specific treatment especially in the threat of potential subsequent waves and future pandemics.

Detailed description: In response to the health crisis, it is the responsibility of clinicians to audit and collaborate in order to observe the impact of the pandemic on clinical practice. With the restructure of the health infrastructure, there is likely to be changes to the nature of acute referrals to Trauma and Orthopaedics, operative and anaesthetic casemix, polytrauma and open fractures as well as the role of technology to reduce viral transmission. Patient safety ought to be prioritised at all times but a national narrative is required to equip healthcare services to counter the pandemic at various time intervals post-social distancing and lockdown at 1.5, 3, 6, 12, 18 and 24 months. This will act as an audit to compare and contrast if the reconfiguration of healthcare services is abiding by the governmental, DoH, NHS, WHO, RCS and BOA (BOAST) policies and guidelines.

Eligibility criteria: Inclusion Criteria:

* anyone presenting with orthopaedic trauma to the Emergency Department who has been referred to the on-call Trauma and Orthopaedic team for further management.

Exclusion Criteria:

* spinal trauma

Primary outcomes:
measure: Treatment
timeFrame: duration of study
measure: Mortality rate
timeFrame: duration of study
measure: Number of COVID positive patients
timeFrame: duration of study
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
References:
citation: Park C, Sugand K, Nathwani D, Bhattacharya R, Sarraf KM. Impact of the COVID-19 pandemic on orthopedic trauma workload in a London level 1 trauma center: the "golden month". Acta Orthop. 2020 Oct;91(5):556-561. doi: 10.1080/17453674.2020.1783621. Epub 2020 Jun 23.
Clinical trial NCT01586988: A Parenting and Self-Care Intervention for HIV Infected Mothers
Official title: A Parenting Intervention for HIV+ Moms: The IMAGE Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Parenting
self-care
disclosure
medication adherence
mother
child
adolescent
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-04-27
Enrollment: 124
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The IMAGE intervention was developed to improve parenting and self-care skills in mothers infected with HIV. It is expected that an improvement in these areas will in turn improve the mother's physical and mental health as well as the child's mental health and behavioral adjustment.

Detailed description: Worldwide, close to half the adults living with HIV are women and a large proportion of these women are of child-bearing age. Whereas anyone living with HIV faces the physical challenges of living with a chronic disease, as well as the material and social impact of the stigma associated with the disease, mothers living with HIV must also meet the demands of childrearing while mitigating the negative impact of the disease upon their family. Mothers with HIV report that this is their greatest source of stress. Moreover, children of these mothers, growing up with a parent with a chronic, stigmatized, and often fatal disease, are considered a high-risk group. The IMAGE intervention was designed to improve parenting and self-care skills in mothers with HIV in order to improve the mother's physical and mental health as well as the child's mental health and behavioral adjustment.

Eligibility criteria: Inclusion Criteria:

* mother has confirmed diagnosis of HIV
* well (HIV-) child, 6 to 14 years of age
* mother is English or Spanish speaking
* child is English speaking

Exclusion Criteria:

* low cognitive/intellectual functioning (\<75) in mother or child
* psychosis in mother or child

Primary outcomes:
measure: Targeted Behaviors, Practices, and Skills and Maternal and Child Health
timeFrame: 3-months, 6-months, and 12-months
Secondary outcomes:
measure: Parenting Self-efficacy
timeFrame: 3-months, 6-months, and 12-months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA, Isap
state: California
Study officials:
References:
citation: Murphy DA, Armistead L, Payne DL, Marelich WD, Herbeck DM. Pilot trial of a parenting and self-care intervention for HIV-positive mothers: the IMAGE program. AIDS Care. 2017 Jan;29(1):40-48. doi: 10.1080/09540121.2016.1204416. Epub 2016 Jul 4.
Clinical trial NCT04323488: Neural Mechanisms of Successful Intervention in Children With Dyslexia
Official title: Neural Mechanisms of Successful Intervention in Children With Dyslexia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslexia, Developmental
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-03-26
Enrollment: 87
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: subjects are seen before and after receiving 8 weeks of reading instruction
Primary purpose: BASIC_SCIENCE

Brief summary: Dyslexia, an impairment in accurate or fluent word recognition, is the most common learning disability affecting roughly ten percent of children. This proposal capitalizes on cutting edge neuroimaging methods, in combination with reading education programs, to generate a new understanding of how successful reading education shapes the development of the brain circuits that support skilled reading. A deeper understanding of the mechanisms of successful remediation of dyslexia, and individual differences in learning, will pave the way for personalized approaches to dyslexia treatment.


Eligibility criteria: Inclusion Criteria:

* Reading difficulties defined as low scores on standardized measures of reading skills

Exclusion Criteria:

* no major contraindication for MRI (braces, metal implants, pacemakers, vascular stents, or metallic ear tubes).
* Because the study involves measurements of reading and language ability, new recruits will be native English speakers.
* Subjects have no history of neurological disorder, significant psychiatric problems
* exclude claustrophobic subjects since an MRI might be uncomfortable for them.

Primary outcomes:
measure: White matter plasticity
timeFrame: Change between baseline (within 2 weeks pre-intervention) and post-intervention (within 2 weeks post-intervention)
measure: White matter plasticity
timeFrame: Change between baseline (within 2 weeks pre-intervention) and post-intervention (1 year follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT05472688: My Baby Biome: Infant Stool Samples for Microbiome Health (MBB)
Official title: My Baby Biome: Infant Stool Samples for Microbiome Health (MBB)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dysbiosis
Lead sponsor: Persephone Biosciences
Sponsor class: INDUSTRY
First posted: 2022-07-25
Enrollment: 430
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is anticipated that 600 infants will enroll in this study. It is preferred that enrollment is balanced by sex; however, it is not required. All efforts will be made to provide racial/ethnic balance, with a goal of 20% African American and 10% each of patients with Asian or Hispanic descent. Additionally, we will look to maintain a demographic that represents different birth and feeding modes.

Brief summary: My Baby Biome is an observational study that will use 600 infant stool samples to determine the biomarkers associated with a healthy infant gut. Biomarkers identified in this study will be used to develop precision probiotics and LBPs for improving infant gut health outcomes to the benefit of all infants. Parents will be asked to submit follow-up questionnaires regarding infant immune health to improve insights obtained from the data.


Eligibility criteria: Exclusion Criteria:

* Infants under 2 weeks or over 2 months old
* Infants given any antibiotic or probiotic treatments
* Infants delivered prematurely or admitted to the NICU outside of establishment of normal feeding
* Infants with mothers under the age of 18
* Infants with mothers known to have HIV, Hepatitis A, Hepatitis B, Hepatitis C, or SARS-CoV2

Primary outcomes:
measure: Determine the composition of a healthy infant microbiome
timeFrame: 6-12 Months
Secondary outcomes:
measure: Evaluate impact of the microbiome on immune adverse events
timeFrame: 7 Years
measure: Build a library of samples and data for future research
timeFrame: 6-12 Months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Persephone Biosciences, Inc.
state: California
Study officials:
References:
Clinical trial NCT01315288: A Randomized Trial of Clinical Decision Making in Asymptomatic Carotid Stenosis
Official title: A Randomized Trial of Clinical Decision Making in Asymptomatic Carotid Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Stenosis
Keywords: Medical decision making
Asymptomatic Carotid Stenosis
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine patient variables, physician presenter variables, and information variables that might affect clinical decision making in asymptomatic carotid stenosis. The hypothesis is that information variables are the most significant determinant of clinical decision making.


Eligibility criteria: Inclusion Criteria:

* No known history of carotid stenosis

Exclusion Criteria:

* History of dementia
* Unable to read English

Primary outcomes:
measure: Decision regarding surgery
timeFrame: Approximately 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
References:
Clinical trial NCT06195488: Gastric Ultrasound in Diabetic Patients
Official title: Preoperative Evaluation of Gastric Contents in Diabetic Patients With Gastric Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Emptying
Diabetes
Ultrasound
Keywords: fasting
gastric ultrasound
preoperative fasting
diabetes
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 1
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetic and non-diabetic patients aged 40-65 years undergoing ASA I-III elective surgery

Brief summary: The American Society of Anesthesiologists (ASA) does not specify a fasting period for patients with certain comorbidities, such as diabetes, for elective surgery, and does not make a separate recommendation for surgery.

The European Society of Anesthesiology (ESA) guidelines do not differentiate between diabetic patients and normal patients. Aspiration of gastric contents is a common cause of perioperative morbidity and mortality.

Aspiration can cause hypoxia, bronchospasm, pneumonia, acute respiratory distress syndrome and death.

The presence of food or fluid in the stomach before induction of anesthesia is one of the greatest risk factors for perioperative pulmonary aspiration. Sedation and general anesthesia suppress or inhibit physiologic mechanisms (tone of the lower esophageal sphincter and upper airway reflexes) that protect against aspiration.

Because restriction of fluid and food intake before general anesthesia is vital for patient safety, Anesthesiology societies have developed guidelines for preoperative fasting.

Current ASA guidelines recommend at least 2 hours fasting for clear liquids, 6 hours fasting after a light meal (toast and clear liquids) and 8 hours fasting after a high calorie or fat meal. The information obtained from gastric ultrasound allows anesthesiologists to determine the optimal timing of procedures, type of anesthesia and airway management technique.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained 40-65 BMI\<40 ASA I-III Fasting for at least 8 hours Elective surgery

Exclusion Criteria:

* Pregnancy Upper gastrointestinal malignancy Large Hiatal Hernia Kidney failure Liver failure Opioid use Use of drugs affecting motility Previous upper abdominal surgery BMI ≥40 kg/m2 Emergency surgery Diabetic ketoacidosis Sepsis

Primary outcomes:
measure: determine stomach fullness
timeFrame: baseline (before intubation)
Secondary outcomes:
measure: Incidence of risk factors
timeFrame: during surgery
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University Medicine Faculty
state: Kozlu
Study officials:
References:
Clinical trial NCT05753488: The Effect of Biomarkers of Inflammation on Graft Function in Kidney Transplantation
Official title: The Effect of Biomarkers of Inflammation on Graft Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Transplant Failure and Rejection
Inflammation
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients underwent renal transplantation

Brief summary: The aim of the study was to investigate the relationship of inflammation markers with postoperative graft function and mortality in patients undergoing kidney transplantation.


Eligibility criteria: Inclusion Criteria:

* patients underwent renal transplantation

Exclusion Criteria:

* patient refusal

Primary outcomes:
measure: RDW
timeFrame: baseline
measure: PNI
timeFrame: baseline
measure: De Ritis
timeFrame: baseline
measure: graft function
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References:
Clinical trial NCT01052688: Noninvasive Screening for Affected Pregnancies: Assay Development & Optimization in Affected Pregnancies
Official title: Noninvasive Screening for Fetal Chromosomal Aneuploidy and Abnormality: Assay Development & Optimization in Affected Pregnancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Down Syndrome
Aneuploidy
Keywords: Down syndrome, aneuploidy, amniocentesis, chorionic villus sampling, Trisomy
Lead sponsor: Sequenom, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-20
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women who have been definitively diagnosed by amniocentesis, CVS or QF/PCR as carrying a fetus with aneuploidy

Brief summary: To collect samples for the purpose of developing and optimizing an in vitro noninvasive prenatal diagnostic (NIPD) test. The NIPD test employs circulating cell free (ccff) DNA extracted from whole blood samples collected from women who are pregnant with a fetus previously determined to have a chromosomal abnormality. The NIPD result will be compared to the standard test results obtained from other test methods such as karyotype, FISH, QF-PCR, and/or any commercially available NIPD test.


Eligibility criteria: Inclusion Criteria:

* Subject is female
* Subject is 18 years or older
* Subject is no less than 8 and no more than 36 weeks gestation
* Subject provides a signed and dated informed consent
* Subject agrees to provide one or more 30-50mL blood sample(s) in accordance with the protocol
* Subject has a current pregnancy in which the fetus is known to have chromosomal aneuploidy (e.g. T13, T18, T21)

Exclusion Criteria:

* Non-singleton pregnancy in which only one fetus is known to have a chromosomal aneuploidy

Primary outcomes:
measure: NIPD result compared to standard test results
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Perinatal Care Associates
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital and medical Center
state: Arizona
city: San Diego
country: United States
facility: Sharp Grossmount
state: California
city: San Diego
country: United States
facility: IGO
state: California
city: San Diego
country: United States
facility: San Diego Perinatal Center
state: California
city: San Diego
country: United States
facility: Women's Healthcare at Frost Street
state: California
city: Washington
country: United States
facility: Reiter, Hill, Johnson and Nevin
state: District of Columbia
city: Honolulu
country: United States
facility: Fetal Diagnostic Institute of the Pacific
state: Hawaii
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Providence
country: United States
facility: Women and Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Sequenom, Inc.
name: Juan-Sebastian Saldivar, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02890888: Effect of Hyperbaric Oxygen on Functional Connectivity in Patients With Cerebral Small Vessel Disease
Official title: The Effect of Hyperbaric Oxygen on the Functional Connectivity of Resting State Neural Networks in Patients With Cerebral Small Vessel Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cerebral Small Vessel Diseases
Keywords: small vessel disease of the brain
hyperbaric oxygen
functional connectivity MRI
Lead sponsor: St. Luke's Hospital, Chesterfield, Missouri
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2016-09-07
Enrollment: 6
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients will have a Functional MRI before and after 10 hyperbaric Oxygen treatments.

Detailed description: Functional MRI studies will be done before and 4-6 weeks after Hyperbaric Oxygen treatment to assess changes in connectivity of resting state neural networks. 10 hyperbaric treatments at 2 atmospheres absolute for 1 hour at pressure will be administered. A review of symptoms and and thorough clinical neurological examination by an experienced neurologist familiar with these studies will be done before and 4-6 weeks after the hyperbaric treatments.

Eligibility criteria: Inclusion Criteria:

* White Matter Hyperintensities on MRI
* 2 or more neurological symptoms or impairments e.g. gait disturbances, disequilibrium, cognitive decline, dysmetria, hyper-rflexia

Exclusion Criteria:

* Contraindication to hyperbaric oxygen treatment e.g. pulmonary emphysema, seizure disorder
* major eustachian tube dysfunction
* stroke with previous 6 months
* extreme cognitive impairment
* major depression
* history of migraine, electroshock therapy, brain irradiation, brain tumor, head trauma
* other uncontrolled co-morbidities, e.g. diabetes, renal or hepatic dysfunction, hypertension, thyroid disorders, carotid artery stenosis (\>70%)

Primary outcomes:
measure: Change in average functional connectivity (fc) within the Default Mode Network and the Dorsal Attention Network will be obtained by resting state network (rsn) functional connectivity (rsnfc) MRI.
timeFrame: Change in baseline rsnfc before and 4 weeks after hyperbaric oxygen
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: St. Luke's hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Mallinckrodt Institute of Radiology/Washington University Medical School
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: John D. Davidson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03091088: Effects of Physical Exercise to Prevent Osteoporosis in Postmenopausal Women
Official title: Efecto de Dos Tipos de Ejercicio físico Para Prevenir la Osteoporosis en Mujeres Postmenopausicas, un Ensayo Clinico Aleatorizado
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis, Postmenopausal
Osteoporosis, Osteopenia
Physical Activity
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 36
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: According to the World Health Organization criteria, osteoporosis was defined as a bone mineral density that lies 2.5 standard deviations or more below the average value for young healthy women. Osteoporosis is a major cause of fractures and can lead to serious complications in postmenopausal women. For this reason, approaches to prevent the appearance and progression of osteoporosis are of primary importance. This randomized clinical trial analyzes the effects of two types of physical exercise oriented to prevent osteoporosis in postmenopausal women with pharmacological supplements of Calcium and Vitamin-D.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal woman
* Pharmacological treatment (VitaminD+Calcium)

Exclusion Criteria:

* Disease or physical-mental condition which prevents to perform the proposed physical exercise

Primary outcomes:
measure: Femoral neck T-score
timeFrame: Change from baseline score at two years
measure: Lumbar spine T-score
timeFrame: Change from baseline score at two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Garcia-Gomariz C, Blasco JM, Macian-Romero C, Guillem-Hernandez E, Igual-Camacho C. Effect of 2 years of endurance and high-impact training on preventing osteoporosis in postmenopausal women: randomized clinical trial. Menopause. 2018 Mar;25(3):301-306. doi: 10.1097/GME.0000000000001005.