louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06438003: Improving Healthy Living Opportunities: Laurel HARVEST
Official title: Improving Healthy Living Opportunities: Laurel HARVEST
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Obesity
Keywords: Health Equity
Food Insecurity
Rural
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this pre-post intervention study is to understand how community-engaged approaches to policy, systems, and environmental approaches can work to improve fruit and vegetable consumption and food security status among an Appalachian Kentucky community. The main approaches taken will be to employ a Community Advisory Board to define our target population of need, and appropriate intervention strategies. The investigators aim to understand if nutrition-based programming and food system approaches for lower-income, single-parent households, and multi-generational households can improve health. Participants will engage in annual data collection to assess dietary quality and food security status.


Eligibility criteria: Inclusion Criteria:

* Resident of Laurel of Pike County
* Over 18 years of age

Exclusion Criteria:

* Pregnancy
* Non-English speaking
* Plans to move out of the counties within the next three years

Primary outcomes:
measure: change in food security
timeFrame: Baseline (year 1) and year 3
measure: change in total Healthy Eating Index scores
timeFrame: Baseline (year 1) and year 3
measure: Change in Food and Physical Activity Questionnaire (FPAQ)
timeFrame: Baseline (year 1) and year 3
measure: change in carotenoids
timeFrame: Baseline (year 1) and year 3
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Makenzie Barr-Porter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05837403: The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
Official title: The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fissure in Ano
Keywords: Fissure in Ano
Platelet-Rich Plasma
Lateral Internal Sphincterotomy
Lead sponsor: Al-Kindy College of Medicine
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: use of platelet rich plasma had good effect in treating chronic wounds. healing of perianal fissure could be prolonged and associated with pain. injection of platelet rich plasma under fissure base and edges had the advantage of improved fissure healing and reduction of the pain, with minimal side effects.

Detailed description: Thirty milliliters of venous blood were withdrawn into eight syringes with preloaded 0.4 milliliters of anticoagulant (dextrose solution A) in each syringe to achieve concentration of 9:1.

The mixture centrifuged for 3000 round per minute for three minutes. After centrifugation separation of supernatant from the red blood cells, using three way-stopcock connector to collect the supernatant of all syringes into four new syringes that preloaded with 1 microgram of Prostaglandin E1 that diluted in normal saline (0.05 milliliters).

The four syringes centrifuge at 4000 round per minute for 15 minutes. The supernatant discarded using a three way-stopcock connector. The sediment mixed with vortex mixer (Vortex V-1 plus, BIOSAN).

Eligibility criteria: Inclusion Criteria:

• chronic anal fissure for more than three months

Exclusion Criteria:

* medical comorbidity
* inflammatory bowel disease
* tuberculosis fissure
* HIV infected patients

Primary outcomes:
measure: Healing of fissure
timeFrame: 3 months
Secondary outcomes:
measure: Duration of pain
timeFrame: 3 months
measure: Pain change
timeFrame: 3 months
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Al-Kindy Teaching Hospital
Study officials:
affiliation: Al-Kindy College of Medicine
name: Taghreed Alhaidari, C.A.B.O.G
role: STUDY_CHAIR
References:
Clinical trial NCT04675203: Molecular Mechanisms of Tooth Eruption
Official title: Molecular Mechanisms of Tooth Eruption
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tooth Eruption
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic (Hôpitaux Universitaires de Strasbourg, France)

Brief summary: The main objective is to study the expression of molecules involved in tooth morphogenesis and eruption in healthy patients, and then to compare them with the results in patients with abnormalities of eruption (results obtained via a collection of biological samples of rare diseases already authorized).


Eligibility criteria: Inclusion Criteria:

* Patient over 12 years old who has given his consent
* Patient whose legal representatives have given their consent for the use of operating waste destined for incineration
* Patient undergoing oral surgery at the University Hospitals of Strasbourg, at the origin of the production of surgical waste such as teeth and bone fragments
* Patient affiliated to a social security system

Exclusion Criteria:

* Refusal to participate
* Patient with chronic systemic pathology
* Patient under long-term drug treatment
* Patient presenting a rare pathology with oral manifestation
* Patient with a history of chemotherapy or head and neck radiotherapy
* Non-French speaking patient / inability to give informed information
* Patient under guardianship, curatorship or legal protection

Primary outcomes:
measure: Expression and localization of molecules involved in tooth eruption
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT03801603: Improving HPV Vaccination Rates Among Rural and Native American Adolescents
Official title: Accelerating Uptake of the HPV Vaccine Among Rural and Native American Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV Vaccinations
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 263
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will develop and implement a multi-level intervention aimed at improving human papillomavirus (HPV) vaccination rates at an Indian rural health clinic.

Detailed description: The focus of this study is to develop, implement, and evaluate a human papillomavirus (HPV) vaccination program aimed at accelerating vaccine uptake among rural and Native American adolescents ages 11-17. HPV vaccination coverage with at least one dose remains disproportionately lower among rural adolescent compared to adolescents residing in urban areas and the rate of series completion is lower among Native American adolescent girls compared to non-Hispanic White adolescent girls.

Eligibility criteria: Inclusion Criteria:

* Clinic patients between the ages of 11-17 who are eligible for the HPV vaccine

Exclusion Criteria:

* None

Primary outcomes:
measure: Clinic HPV Vaccination Rates
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Comprehensive Cancer Center
state: California
Study officials:
References:
Clinical trial NCT03930303: Anxiety Scores With Media Based Patient Education Before Dilatation and Curettage
Official title: Impact of Media-based Patient Education on Anxiety Scores in Patients Undergoing Dilatation and Curettage at Office Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abnormal Uterine Bleeding
Anxiety
Keywords: dilatation and curettage
multimedia based education
anxiety
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Subjects with abnormal uterine bleeding and scheduled for dilatation and curettage (D\&C) will be randomized to a multimedia-based education (MME group) or verbal information (Control group ) before (D\&C). State-Trait Anxiety Inventory will be asked by the nursing staff before and after multimedia-based education or verbal information to all patients. Then the patients will undergo (D\&C) at an office setting. The impact of MME on patient anxiety will be evaluated by statistical analysis.

Detailed description: Subjects with abnormal uterine bleeding and scheduled for dilatation and curettage (D\&C) with diagnostic or treatment purpose will be randomized to two intervention arms. Multimedia-education Group (MME group) and verbal information group (Control Group). Both groups will receive State-Trait Anxiety Inventory before and after education and then will undergo D\&C at an office setting. State-Trait Anxiety Inventory will be asked by the nursing staff. Multimedia-based education will be carried out using a 5 minutes video explaining the details of D\&C. D\&C will be carried out at office setting by an experienced gynecologist under sedation and analgesia.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of abnormal uterine bleeding Scheduled for dilatation and curettage Must understand the characteristics of the study

Exclusion Criteria:

Psychological disease Contraindication for hysteroscopy Visual deficit, Auditory deficit

Primary outcomes:
measure: Change in State-Trait Anxiety Inventory score from baseline to watching video or verbal information
timeFrame: 30 minutes before and 10 minutes after multimedia education/verbal information
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
state: Please Enter The State Or Province
Study officials:
affiliation: Kanuni Sultan Suleyman Hospital
name: Huseyin Kiyak, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03884803: Healthy Moms for Healthy Babies
Official title: Healthy Moms for Healthy Babies: Implementation of an Enhanced E-Health Prenatal Program to Promote Maternal Mental Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Medtech-Fonds de soutien à l'innovation en santé et en services sociaux (FSISSS)
First posted: 2019-03-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: HealthyMoms is prototype website with accurate and easily accessible information on the impact of depression, anxiety and stress during pregnancy and the importance of healthy behaviours (physical activity, nutrition, sleep). This clinical trial is to pilot test the implementation of the e-health intervention alongside standard antenatal care.


Eligibility criteria: Inclusion Criteria:

* Able to communicate in French or English
* At least 18 years of age
* First child
* Internet and email access

Exclusion Criteria:

* Do not meet inclusion criteria

Primary outcomes:
measure: Acceptability of healthymoms website
timeFrame: 6 weeks post intervention
measure: Change from baseline on depressed mood
timeFrame: study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery
Secondary outcomes:
measure: Changes from baseline on pregnancy related anxiety
timeFrame: study entry, 6 weeks post intervention
measure: Changes from baseline in physical activity
timeFrame: study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery
measure: Changes from baseline on sleep quality
timeFrame: study entry, 6 weeks post intervention, 3 months post delivery, 6 months post delivery
measure: Changes from baseline regarding satisfaction with antenatal care
timeFrame: study entry, 6 weeks post intervention
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
References:
Clinical trial NCT04491903: REBOA for Out-of-hospital Cardiac Arrest
Official title: REBOA for Out-of-hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiac Arrest
Lead sponsor: neurescue
Sponsor class: INDUSTRY
First posted: 2020-07-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cardiac arrest is a major health problem that carries a high mortality rate. Substantial research and development have been put into changing the outcome of cardiac arrest and despite the advent of automated external defibrillators (AED), increase in bystander Cardiopulmonary resuscitation (CPR) and automated CPR devices (ACPR), the proportion of patient survival to hospital discharge has only minimally improved.

The objective is to investigate safety and performance of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure as an adjunct to Advanced Life Support (ALS) for treatment of refractory cardiac arrest.

Detailed description: The scope of the study is to collect data on patients with refractory out of hospital cardiac arrest (OHCA) for this feasibility study.

Data collected:

* from enrolment of the patient until hospital arrival
* every 24 hours
* at discharge or 7 days post enrollment
* at 30 days post enrollment

The investigation is initiated to investigate the safety and performance of the REBOA procedure for patients experiencing refractory OHCA.

Eligibility criteria: Inclusion Criteria:

* Witnessed cardiac arrest
* Bystander or professional CPR within 5 minutes
* Refractory cardiac arrest

Exclusion Criteria:

* End Tidal CO2 \<1,3 kPa
* Traumatic cardiac arrest
* Women with known pregnancy
* Patients with known terminal disease
* Patients with known do-not-attempt-CPR order
* Patients with overdose

Primary outcomes:
measure: Central blood pressure
timeFrame: 1 hour
Secondary outcomes:
measure: Return of spontaneous circulation (ROSC)
timeFrame: 1 hour
measure: Changes in cardiac rhythm following balloon inflation
timeFrame: 1 hour
measure: During procedure - time from first needle stick to successful sheath insertion
timeFrame: 1 hour
measure: During procedure - time from first needle stick to finalized balloon inflation
timeFrame: 1 hour
measure: End-tidal CO2 (EtCO2)
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06421103: Micro-dosing Indocyanine Green (ICG) in Children
Official title: Investigating Micro-dosing of Indocyanine Green (ICG) for Intraoperative Perfusion Assessment in Children.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perfusion
Fluorescence Imaging
Gastrointestinal Tract Disorders
Genitourinary Disease
Keywords: Paediatric Surgery
Pediatric Surgery
Fluorescence
Imaging
Fluorescence Guided Surgery (FGS)
Intra-operative perfusion assessment
Indocyanine Green
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 90
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Dose escalation with backfilling.
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this cohort study is to identify the lowest dose of Indocyanine Green (ICG) that achieves satisfactory intra-operative fluorescence for the assessment of gastrointestinal or genitourinary tract perfusion in children.

Detailed description: Indocyanine Green (ICG) fluorescence-guided surgery (FGS) can be used to assess gastrointestinal and genitourinary tract perfusion intra-operatively. In adults, the use of ICG has been shown to improve surgical outcomes. ICG is safely used intra-operatively in children, but there is a lack of evidence regarding the lowest clinically useful dose of ICG.

This is a single centre open-label dose escalation study that aims to:

1. identify the minimal clinically useful dose of ICG for intra-operative perfusion assessment in children (0 - 18 years old)
2. assess the safety profile of intra-operative ICG in children
3. characterise the intra-operative fluorescence of ICG in children

Eligibility criteria: Inclusion Criteria:

* Children aged ≤18 years of age
* Elective surgery including gastrointestinal or genitourinary tract perfusion assessment

Exclusion Criteria:

* Renal and liver dysfunction
* Active infection
* Coagulopathy
* Complex congenital heart defect
* Previous documented allergy to ICG injection or other iodinated contrast agents
* Patients suffering from hyperthyroidism or autonomic thyroid adenomas
* Premature infants or neonates in whom exchange transfusion is indicated, due to the hyperbilirubinaemia risk
* Concurrent use of sodium bisulphite-containing preparations, such as certain heparin preparations

Primary outcomes:
measure: Minimum clinically useful dose of ICG in children
timeFrame: 60 minutes (intra-operative)
measure: Number of adverse drug events at each dose level
timeFrame: 30 days
Secondary outcomes:
measure: Surgical complications
timeFrame: 30 days
measure: Post-operative morbidity
timeFrame: 90 days
measure: Length of stay
timeFrame: 90 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children
Study officials:
affiliation: Great Ormond Street Hospital
name: Stefano Giuliani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02202343: Effectiveness of School-based Health and Nutrition Education to Improve Health and Dietary Practices of Primary School Children From Jimma Zone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behaviour
Keywords: Nutrition
Food
Security
School
Health
Lead sponsor: Jimma University
Sponsor class: OTHER
Collaborators: name: World Bank
name: Ethiopian Public Health Institute
First posted: 2014-07-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: School based Health and Nutrition Education (SHNE) is a key component of school health and nutrition programs that can address several health and nutrition issues in Ethiopia.


Eligibility criteria: Inclusion Criteria:

* Grade 5 to 8

Exclusion Criteria:

* Mental Problem
* Has no Family

Primary outcomes:
measure: Effectiveness of school based health and nutrition education on on health, diet related behavior and food security
timeFrame: 1 year
Secondary outcomes:
measure: impacts of health and nutritional education on food hygiene and reproductive health
timeFrame: 1 year
Other outcomes:
Locations:
city: Jimma
country: Ethiopia
facility: Jimma University
state: Oromia
Study officials:
affiliation: Jimma University
name: Alemayehu A Alemayehu, Researcher
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02797743: Whole Blood Specimen Collection From Healthy Subjects
Official title: Whole Blood Specimen Collection From Healthy Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Lead sponsor: Progenity, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-13
Enrollment: 750
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men, pregnant women or children, no age restrictions.

Brief summary: This study will obtain whole blood specimens from healthy subjects to be used for research and development and clinical validation of genetic assays.

Detailed description: Progenity is developing diagnostic products to improve the healthcare of men, women, and children. The commercial objective is to make safe, noninvasive genetic testing available to the public, independent of age and other factors that may contribute to pregnancy or other clinical complications.

Sample specimens will not be used to develop genetic lines and/or DNA banks for cloning. Any samples or remnant specimens remaining may be stored indefinitely for future research programs.

Eligible subjects (or parent/guardian) will provide written informed consent after which basic demographic and clinical data will be obtained and a whole blood sample will be collected. A subject's participation may end immediately after their blood draw. The amount of whole blood drawn at any visit will be based upon age of the subject and test to be performed.

In the event a Subject is pregnant, information regarding the gender of the fetus established by either ultrasound, non-invasive prenatal testing (NIPT) results, or at delivery will be collected. Clinical data regarding any karyotyping procedure that may occur on the fetus will be recorded.

Eligibility criteria: Inclusion Criteria:

* Subject (or guardian)is willing to provide written informed consent to have up to 50 mL of whole blood collected at a single clinic visit (maximum blood volume will depend on age of subject)
* Subject is considered healthy (and if pregnant, their pregnancy is progressing normally)
* If pregnant, Subject is carrying a singleton fetus of 10 to 26 weeks' gestational age inclusive

Exclusion Criteria:

* Women who are not pregnant
* If pregnant, pregnancy is non-viable
* If pregnant, evidence of or suspected fetal anomaly based on ultrasound finding, abnormal 1st trimester screening or abnormal NIPT
* Immediate family history of a previous fetal aneuploidy

Primary outcomes:
measure: Whole blood collection
timeFrame: about 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Eunice
country: United States
facility: Heinen Obstetrics & Gynecology
state: Louisiana
city: Voorhees
country: United States
facility: Virtua Medical Group
state: New Jersey
city: Cincinnati
country: United States
facility: Cincinnati Obgyn
state: Ohio
Study officials:
affiliation: Head of Clinical Affairs
name: Peter Stiegler, PhD
role: STUDY_DIRECTOR
References: