louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05319834: Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth
Official title: Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preterm Birth
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 256
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.
Primary purpose: PREVENTION

Brief summary: This is a double blinded randomized placebo controlled clinical trial to detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.

Detailed description: The included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1), or vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2).

Eligibility criteria: Inclusion Criteria:

1. Women of any age
2. Any parity
3. Healthy singleton pregnancy
4. History suggestive of one or more previous PTB
5. Current pregnancy (16-20) weeks gestation.

Exclusion Criteria:

1. Multifetal pregnancy.
2. History of ante partum PROM.
3. Cervical Incompetence or current cervical cerclage.
4. Known fetal anomaly.
5. Hypertension requiring medications.
6. History of Thrombo-embolic disorders.
7. Known allergy to progesterone or asprin.
8. Known liver disease.
9. Established preterm labor
10. Short cervix

Primary outcomes:
measure: Number of participants who will deliver before 34 weeks gestation.
timeFrame: 18 month
Secondary outcomes:
measure: The number of participants who have prolongation of pregnancy after 34 till 37 weeks gestation
timeFrame: 18 months
measure: Neonatal outcomes
timeFrame: 18 months
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University
Study officials:
References:
Clinical trial NCT05711134: CT C-spine Audit and Feedback
Official title: Audit and Feedback for Computed Tomography of the Cervical Spine in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Spine Injury
Emergencies
Trauma
Keywords: computed tomography
resource utilization
NEXUS
emergency medicine
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a prospective quality improvement study to assess the effect of using an audit-and-feedback process for emergency providers on utilization of computed tomography of the cervical spine. The objective of this study is to determine whether providing repeated individualized feedback on CT C-spine utilization to emergency providers alters their practice pattern and reduces overutilization. The investigators hypothesize that emergency providers who receive individualized feedback regarding their CT C-spine utilization on a regular basis will alter their practice pattern to reduce overutilization of this imaging study.


Eligibility criteria: Inclusion Criteria:

* Emergency medicine physician, nurse practitioner, or physician assistant
* Ordered at least 5 CT scans of the cervical spine on adult patients in the two-month pre-intervention period

Exclusion Criteria:

* Non-emergency providers
* Ordered few than 5 studies in the pre-intervention period

Primary outcomes:
measure: Percent NEXUS-Negative
timeFrame: 6 months
Secondary outcomes:
measure: Number of Fractures
timeFrame: 6 months
measure: Clinically Significant Fractures
timeFrame: 6 months
measure: Number of CTs
timeFrame: 6 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts Chan Medical School
name: Karl T Chamberlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04628234: Follow-up of Actual Patient Care Site Two Months After Hospitalisation Compared With Their Expressed Choice Regarding Subsequent Care Site (RESPECT)
Official title: Follow-up of Actual Patient Care Site Two Months After Hospitalisation Compared With Their Expressed Choice Regarding Subsequent Care Site
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Malignancy
Tumor, Solid
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an onco-hematologic solid tumor in palliative care

Brief summary: This is a non randomized, monocentric, descriptive, transversal and prospective study. The purpose of this study is to assess the compliance with patient expressed choice regarding subsequent care and death -if occured- site (at hospital or at home) after hospitalisation for terminally ill patients with an onco-hematologic solid tumor in palliative care and to identify reasons for potential non-compliance.

Detailed description: Patients will reply to two questionnaires, at inclusion and two months after inclusion. Primary care physician will also be contacted by phone to reply to two questionnaires, at inclusion and two months after inclusion.

Eligibility criteria: Inclusion Criteria:

* Patients must be ≥ 18 years old
* Patients with onco-hematologic solid tumor (locally advanced or metastatic) against which specific and systemic treatments are outdated or have been stopped (symptomatic palliation with radiotherapy is allowed)
* Patients admitted in full hospitalisation
* Patients able to speak, read and understand French
* Patients able to answer the phone
* Signed informed consent from the patient
* Patients must have a social security coverage

Exclusion Criteria:

* Patients \< 18 years old or incapable person ≥ 18 years old
* Patients admitted for any surgical intervention
* Patients unable to read French
* Patients whose physical or psychological condition do not allow them to answer orally or in writing
* Patients deprived of liberty
* Patients placed under judicial protection
* Women that are pregnant or breast-feeding

Primary outcomes:
measure: Number of patients for which their choice of care and death -if occured- site (at hospital or at home) is respected.
timeFrame: 2 months after inclusion
Secondary outcomes:
measure: Number of new hospitalisations occuring after inclusion, if any.
timeFrame: 2 months after inclusion
measure: Duration of new hospitalisations occuring after inclusion, if any.
timeFrame: 2 months after inclusion
measure: Reasons for new hospitalisations occuring after inclusion, if any.
timeFrame: 2 months after inclusion
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg Europe
Study officials:
References:
Clinical trial NCT02192034: Optimizing Navigation to Successful Colorectal Cancer Screening
Official title: Optimizing Navigation to Successful Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Keywords: Colonoscopy
Colon cancer
screening
navigation
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2014-07-16
Enrollment: 156
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: Colorectal cancer is the second leading cause of death from cancer in the United States. Two major barriers to successful colorectal cancer screening are appointment keeping and proper bowel preparation. The purpose of this study is to test the efficacy of a patient navigation program to increase colorectal cancer screening at Rush University Medical Center. The investigators hypothesize that colorectal cancer screening will be improved for subjects who utilize a patient navigator.


Eligibility criteria: Inclusion Criteria:

* Subject deemed appropriate for colorectal cancer screening by colonoscopy by a primary care physician
* Age 50 or greater or 40 or greater with family history of colorectal cancer in first degree relative
* Average risk for screening as defined as absence of symptomatic abdominal pain and active GI bleeding

Exclusion Criteria:

* Age \> 75 years old
* Congestive Heart Failure
* Chronic Obstructive Pulmonary Disease
* Myocardial Infarction
* Weight greater than 350 pounds
* Anticoagulation
* Inability to speak English

Primary outcomes:
measure: Navigation role in colorectal cancer screening
timeFrame: Up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Joshua E Melson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04344834: Short and Long-term Psychological Impact of Covid-19 on The Egyptians
Official title: Psychological Impact of Covid-19 on The Egyptians
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Health Issue
Keywords: Covid-19
Egyptian
Health workers
population
mental health
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health care workers, patients recovered from COVID-19 and general population

Brief summary: The World Health Organization (WHO) has recently declared coronavirus disease 2019 (Covid-19) a public health emergency of international concern. Impact of the pandemic of covid-19 on the mental health of patients, health care workers and general population would be affected.

Detailed description: Health care workers and general population will be included in the study. A questionnaire will be used to assess their knowledge and practices regarding covid-19 and its impact on mental health.

Patients Mental health will be assessed regarding anxiety, depression and obsessive compulsive disorder, sleep disorder will be assessed.

Eligibility criteria: Inclusion Criteria:

* Egyptian population

Exclusion Criteria:

* Patients not accepting to participate in the questionnaire

Primary outcomes:
measure: Depression
timeFrame: 6 months
measure: Anxiety
timeFrame: 6 months
measure: Obsessive compulsive disorder
timeFrame: 6 months
measure: Sleep disorder
timeFrame: 6 months
measure: Psychological problems
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT04944134: COVID-19 Antibody Levels After Vaccines
Official title: Vaccine Ig Levels in Nasal Mucosa as Measured by Nasal Epithelial Lining Fluid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccine Preventable Disease
Keywords: COVID-19
Vaccination
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Environmental Protection Agency (EPA)
First posted: 2021-06-29
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals vaccinated against COVID-19

Brief summary: This study will measure the levels of nasal mucosal Immunoglobulin A (IgA) and blood serum IgA up to one year after COVID vaccination, as well as examining what factors might affect antibody levels in the nose. This will be done through nasal epithelial lining fluid collection and standard venipuncture.

Detailed description: Based on data demonstrating that SARS-CoV-2 infections results in virus-specific nasal IgA levels even in patients with mild infections and no/low serum antibody titers, we hypothesize that COVID vaccinations result in robust nasal IgA levels. Since previous data indicate that SARS-CoV2 specific IgA were transiently present following community-acquired infections, we will follow vaccine-induced nasal IgA levels over time (6-12 months). Our specific aims are as following:

Aim 1: Determine COVID vaccine specific immunoglobulin levels and immune mediator profiles in the nasal mucosa pre- and 14 days post second dose of COVID vaccine.

Aim 2: Determine COVID specific immunoglobulin levels and immune mediator profiles at 3, 6, and 12 months following complete vaccination.

Eligibility criteria: Inclusion Criteria:

* Individuals at least 18 years of age who have or plan to receive a COVID-19 vaccination
* Able to be seen at UNC Chapel Hill's main campus up to 5 times in the next year

Exclusion Criteria:

* Individuals unwilling to give consent

Primary outcomes:
measure: Nasal Mucosal COVID-specific IgA
timeFrame: Up to 14 months
measure: Serum COVID-specific IgA
timeFrame: Up to 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Ilona Jaspers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03034434: Cervical Recuperation After Vaginal Delivery
Official title: Sonography Evaluation of Cervical Recuperation After Vaginal Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervix
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 1384
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after vaginal delivery.

Brief summary: Patients after vaginal delivery will undergo 3 trans-vaginal ultrasounds in order to examine the process of cervical recuperation post delivery.

Detailed description: Patients after vaginal delivery will be recruited after receiving a full explanation and signing an informed consent.

The goal of the study is to examine cervical length after vaginal delivery at 3 different time intervals:

1. 8 hours post delivery.
2. 24 hours post delivery.
3. 48 hours post delivery. At each interval a trans-vaginal ultrasound will be performed, evaluating cervical length. At the end of the 3rd and final ultrasound, the patient will finish her participation in the study/ Information regarding obstetric conditions such as labor induction, gestational age at the time of delivery etc. will be collected from patients' electronic files.

Eligibility criteria: Inclusion Criteria:

* Any patient after vaginal delivery.

Exclusion Criteria:

* Any patient after cesarean section.

Primary outcomes:
measure: Cervical length after vaginal delivery.
timeFrame: Up to 48 hours post delivery.
Secondary outcomes:
measure: Differences in cervical length after vaginal delivery.
timeFrame: Up to 48 hours post delivery.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04122534: Somatic Mindfulness Training for a Healthy Workforce: Student Pilot Sample
Official title: Somatic Mindfulness Training for a Healthy Workforce: Student Pilot Sample
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational-based Secondary Trauma
Lead sponsor: Montana State University
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This pilot study evaluates a somatic mindfulness training. Reductions in mental and physical health correlates of secondary trauma are assessed using a pretest-posttest design.


Eligibility criteria: Inclusion Criteria:

* Participant must be either employed or volunteering as a victim service provider, or enrolled at Montana State University as an undergraduate student.

Exclusion Criteria:

* Participant is under age 18.

Primary outcomes:
measure: Secondary Traumatic Stress Scale
timeFrame: This outcome measure will be assessed at week 15.
Secondary outcomes:
measure: Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: This outcome measure will be assessed at week 15.
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: Montana State University
state: Montana
Study officials:
References:
Clinical trial NCT02120534: Serum CD14 and CD88 Mointoring in ICU
Official title: The Predictive Values of Serum Soluble CD14 Subtype and CD88 Monitoring in Critically Ill Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: soluble CD14 ,serum CD88,sepsis , SIRS.
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2014-04-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of ninety-four patients will be included in the study. Forty seven patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and forty seven patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 and CD88 will be monitored.

Brief summary: The present study will be conducted to determine the dynamic changes of serum soluble CD14 and the corresponding changes of serum CD88 and their correlation in critically ill sepsis and SIRS patients.

Detailed description: A total of ninty four will be included in the study. Forty seven patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and forty seven patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 and CD88 will be monitored.

Eligibility criteria: Inclusion Criteria:

* The patients staying in ICU for more than 24 hours will be included in the study.

Exclusion Criteria:

* Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure; patients received massive blood transfusion; patients with radiation therapy and patients with previous organ transplantation will be excluded from the study.

Primary outcomes:
measure: A serum soluble CD14
timeFrame: one week
Secondary outcomes:
measure: Survival of ICU patients
timeFrame: Two weeks
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Algharbyia
Study officials:
affiliation: Assistant Professor
name: Ayman A Yousef, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05913934: Clubfeet and Twins and Gait Analysis
Official title: Control Gait Analysis in Clubfoot Children and Comparison With Their Healthy Twins
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clubfoot
Keywords: Clubfoot
gait analysis
twin comparison
inertial sensor
footscan
manual-dynamic physiotherapy
derotation
Lead sponsor: Dr.Joller BioMedical Consulting
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children from 3 to 14 years old, beeing treated for clubfeet and their healthy twins.

Brief summary: Children with clubfeet who were exclusively treated by Ursula Issler-Wüthrich for 3 to 14 years with manual-dynamic physiotherapy and their healthy twin siblings are compared using gait analysis.

GaitUp sensors (kinematic) and footscan V9 (kinetic) are the systems used for this comparison.

Nonparametric statistics are applied to verify aberrations.

Detailed description: Control gait analysis in clubfoot children and comparison with their healthy twins

Clubfeet are the most common birth defect with about 80 cases in Switzerland per year. There are two important therapies: Ponseti and manual-dynamic physiotherapy.

Ursula Issler-Wüthrich, physiotherapist, since twenty years treats exclusively clubfeet and comorbidities with clubfeet like arthrogryposis and myelomeningocele. Until today she corrected more than 400 feet with manual-dynamic physiotherapy.

Among her patients there are 11 twin pairs. In the scientific literature it is stated that in unilateral clubfoot, the other foot cannot be considered normal.With the two gait analysis systems meant for controlling the therapy results, the walking pattern of the healthy twin was compared with the pattern of the affected twin sibling.

The basis of the study is a walk over 25 meters with the GaitUp sensors (11 g) resulting in 22 quantitative digital parameters and tests on the pedobarographic plate footscan V9 leading to 10 parameters.

Statistically it will be analyzed whether there is a discrepancy between the clubfeet children and their healthy twins.

The parents in writing and the children orally gladly approved the task.

Eligibility criteria: Inclusion Criteria:

* Twins with clubfeet

Exclusion Criteria:

* All other clubfeet

Primary outcomes:
measure: Differences in gait analyses of treated clubfeet and their healthy twin siblings: p-value
timeFrame: 2 years
measure: Differences in gait analyses of treated clubfeet and their healthy twin siblings:Effect size
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Dr.Joller BioMedical Consulting
Study officials:
affiliation: Dr.Joller BioMedical Consulting
name: Peter Joller, PhD
role: STUDY_DIRECTOR
References: