louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05625880: Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population
Official title: Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population at Dhulikhel Hospital, Kathmandu University Hospital.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaundice, Neonatal
Lead sponsor: Picterus AS
Sponsor class: INDUSTRY
Collaborators: name: St. Olavs Hospital
name: Dhulikhel Hospital
name: National Taiwan Normal University
First posted: 2022-11-23
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Dhulikhel Hospital, Kathmandu Nepal.

Detailed description: This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in 200 newborns at Dhulikhel Hospital, Kathmandu Nepal. The Picterus Calibration Card was placed on the chest of the newborn with the hole in the card placed over the infant's sternum. A validated smartphone with Picterus JP was used to collect digital images.

Eligibility criteria: Inclusion Criteria:

* Infants born with gestational age ≥35 weeks
* Birth weight ≥ 1750g
* Age 1 - ≤14 days
* Infants that will have a blood sample draw

Exclusion Criteria:

* Infants in the need for respiratory support
* Infants with conditions that could compromise skin circulation, as sepsis, heart failure
* Infants that have received phototherapy

Primary outcomes:
measure: Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
timeFrame: 5-10 minutes
Secondary outcomes:
measure: correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn
timeFrame: 1-2 hours
measure: correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns
timeFrame: 5-10 minutes
measure: Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns
timeFrame: 5-10 minutes
Other outcomes:
Locations:
city: Dhulikhel
country: Nepal
facility: Dhulikhel Hospital, Kathmandu University Hospital
Study officials:
affiliation: Dhulikhel Hospital
name: Sunila Shakya, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06316180: The Use of Drospirenone/Estetrol in Random Start Rapid Endometrial Preparation
Official title: The Use of Drospirenone/Estetrol in Random Start Rapid Preparation of Endometrium Before Office Hysteroscopic Polypectomies: a Multicenter, Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endometrial Polyp
Endometrial Diseases
Keywords: Hysteroscopy
Endometrial Preparation
Lead sponsor: University of Palermo
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
First posted: 2024-03-18
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of drospirenone/estetrol, in rapid preparation of endometrium for hysteroscopic polypectomy.


Eligibility criteria: Inclusion Criteria:

* Patients with endometrial polyps.

Exclusion Criteria:

* Patients with other endometrial pathologies.

Primary outcomes:
measure: Quality of endometrial preparation
timeFrame: Intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Andrea Etrusco
city: Rome
country: Italy
facility: Marco Monti
Study officials:
References:
Clinical trial NCT05334680: International Validation of Wearable Sensor to Monitor COVID-19 Like Signs and Symptoms
Official title: Wearable Sensor to Monitor and Track COVID-19-like Signs and Symptoms to Develop Better Care Strategies for COVID-19 Pandemic - An Exploratory Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: Wearable sensor
Machine learning
COVID-19
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: United States - India Science and Technology Endowment Fund
name: Northwestern University
name: Induss Hospitals
name: Bionic Yantra
name: Clinfinite Solutions
name: Indian Institute of Technology Kharagpur
First posted: 2022-04-19
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals who may have experienced COVID-19 like symptoms.

Brief summary: 1. Deploy wearable COVID sensor to collect high resolution physiological data (temperature, cardiac, respiratory and physical activity) from COVID positive patients.
2. Use collected data to train algorithm for assessing the risk of individuals presenting with symptoms suggestive of COVID-19.


Eligibility criteria: Inclusion Criteria:

* Ages between 18-95 years old
* Currently experiencing any COVID-like signs and symptoms such as fever, cough, shortness of breath, trouble breathing, persistent pain or pressure in the chest, confusion or inability to arouse, bluish lips or face.
* Individuals who are not experiencing any COVID like signs and symptoms (will be asked to be healthy control)
* Able and willing to give written consent and comply with study procedures.

Exclusion Criteria:

* Inability to understand instructions and follow a three step command.
* The subject is pregnant, nursing or planning a pregnancy.
* Inability to provide written consent.

Primary outcomes:
measure: Heart Rate
timeFrame: Baseline; Possible reassessment up to five days after consent
measure: Respiratory frequency
timeFrame: Baseline; Possible reassessment up to five days after consent
measure: Cough Frequency
timeFrame: Baseline; Possible reassessment up to five days after consent
measure: Body temperature
timeFrame: Baseline; Possible reassessment up to five days after consent
Secondary outcomes:
Other outcomes:
Locations:
city: Pune
country: India
facility: Lifepoint Multi-Specialty Hospital
state: Maharashtra
city: Mumbai
country: India
facility: St. Georges Hospital
state: Maharastra
city: Hyderabad
country: India
facility: Induss Hospitals
state: Telangana
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01872780: Identification of Null Allelic Variant of CYP2C8 In A Korean Population
Official title: The Effect of CYP2C8 E274Q, a Novel 23452 G>T SNP, on the Disposition of Rosiglitazone in Healthy Subjects: The Genetic Polymorphisms of CYP2C8 in a Korean Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: CYP2C8
genetic polymorphism
rosiglitazone
Korean
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The genotype profile of CYP2C8 was analyzed in a Korean population. Frequency in multi-ethnic population and in vivo functionality of novel null allelic CYP2C8 variant were evaluated.

Detailed description: Whole blood samples from 50 unrelated Korean subjects were genotyped for 3kb of 5' upstream region, all exon-intron boundaries, exons, and UTR regions of CYP2C8 gene by direct sequencing. Genotyping of CYP2C8 has been addressed only for null allelic variant, CYP2C8\*11 using pyrosequencing in the 447 Koreans, 93 African-Americans, 100 Caucasians, 348 Chineses and 100 Vietnameses. Then, in-vivo single PK study of CYP2C8 probe, rosiglitazone(4mg), was conducted in 7 healthy subjects with CYP2C8\*1/\*1 and 2 with CY2C8\*1/\*11.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer

Exclusion Criteria:

* Medical problems in taking probe drug

Primary outcomes:
measure: AUC
timeFrame: 12hr
Secondary outcomes:
measure: Cmax
timeFrame: 12hr
Other outcomes:
Locations:
Study officials:
affiliation: Inje University
name: Jae-Gook Shin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00506480: Assessment of Endometrial Receptivity in Recipients of Donated Oocytes
Official title: Phase 1 Study of Endometrial Markers of Endometrial Receptivity in Oocyte Donation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Embryo Implantation
Keywords: Embryo Implantation
Endometrium
endometrial implantation
Oocyte Donation
in vitro fertilization
endometrial sampling
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-07-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether endometrial receptivity markers obtained by endometrial sampling are effective in prediction of in vivo human embryo implantation.

Detailed description: Since the introduction of In vitro fertilization (IVF), substantial improvements have been developed in ovulation induction, oocyte retrieval, fertilization capability and embryonic development. However, the end point which is to improve implantation and pregnancy rates after transferring embryos, remains below physiological expectations. It has been estimated that clinical implantation in the human is efficient in no more than 30% of cases considering that only one embryo is present in natural cycles, which gives us a 30% implantation rate.

A frequent pitfall found in the literature is the consideration that implantation is the result of good embryonic quality. Although this is completely true, it is not the only truth because the maternal endometrium is at least of equal relevance. In ovum donation, the endometrial factor could also be improved by individualizing the implantation window in each patient. In this proposed research we will analyze suggested markers of endometrial receptivity in order to optimize human implantation in patients undergoing assisted reproductive technologies focusing on improving endometrial receptivity in IVF and ovum donation patients.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for IVF or OD

Exclusion Criteria:

* Cervical stenosis

Primary outcomes:
measure: embryo implantation
timeFrame: 1 MONTH
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah
name: Ariel Revel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Achache H, Revel A. Endometrial receptivity markers, the journey to successful embryo implantation. Hum Reprod Update. 2006 Nov-Dec;12(6):731-46. doi: 10.1093/humupd/dml004. Epub 2006 Sep 18.
Clinical trial NCT06030180: CLUE: CLinical Utility Study of EsoGuard
Official title: CLUE: CLinical Utility Study of EsoGuard on Samples Collected Using EsoCheck as a Triage Test for Endoscopy to Identify Barrett's Esophagus (BE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Barrett Esophagus
Barretts Esophagus With Dysplasia
Esophagus Adenocarcinoma
Lead sponsor: PAVmed Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Utilize real-world data from the commercial use of EsoGuard testing on samples collected with EsoCheck (EC/EG) to evaluate the impact of EsoGuard results on health care provider's decision for endoscopy referral. Assess patient compliance with recommendations for upper endoscopy, and relationship of compliance to positive EsoGuard results.


Eligibility criteria: Inclusion Criteria:

1. Individuals in whom the clinical decision has been made to screen for BE using EC/EG
2. Individuals who meet criteria for BE screening in accordance with either the 2022 ACG guidelines, or the AGA best practice advice from their 2022 clinical practice update.

Exclusion Criteria:

1. Individuals who fall outside the eligible population defined by the EsoCheck device Instructions For Use (IFU)
2. Individuals who do not meet either the ACG or AGA guidelines/practice advice for BE screening
3. Inability to provide written informed consent or participate in the required follow up

Primary outcomes:
measure: Clinical Utility
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Patient Compliance
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Heber Springs
country: United States
facility: Arkansas Heartburn Treatment Center
state: Arkansas
city: Arvada
country: United States
facility: Arvada West Family Medicine,
state: Colorado
city: Littleton
country: United States
facility: Colorado Primary Healthcare
state: Colorado
city: Savannah
country: United States
facility: Savii Health
state: Georgia
city: Dallas
country: United States
facility: James E Race
state: Texas
city: Harlingen
country: United States
facility: Texas Digestive Specialists
state: Texas
city: Shenandoah
country: United States
facility: Gastroenterology Partners of North Houston, PLLC
state: Texas
city: Lindon
country: United States
facility: Premier Family Medical
state: Utah
Study officials:
affiliation: Lucid Diagnostics
name: Gisella Lopez
role: STUDY_DIRECTOR
References:
Clinical trial NCT01693380: Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza
Official title: Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza the in São Paulo, 2009
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Acute Respiratory Infection
Keywords: Influenza
Vaccination
Vaccines
Schoolchildren
Effectiveness
Intervention studies
Adolescents
Laboratory Confirmed Influenza
Lead sponsor: Butantan Institute
Sponsor class: OTHER_GOV
First posted: 2012-09-26
Enrollment: 1742
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated household members.

Detailed description: Children and adolescents play an important role in sustaining the transmission of influenza. Moreover, with the occurrence of influenza in children, there are important socioeconomic consequences to families affected by the disease, related to absenteeism, expenditure on health services and medication use. This study presents an evaluation of direct and indirect effectiveness of influenza vaccination in school age children and their unvaccinated household contacts. It was conducted in 2009, in Sao Paulo - Brazil, through a randomized double-blind community trial, with six months of follow up. For the evaluation of vaccine effectiveness, the influenza vaccine was used for the experimental group, and meningitis conjugate and varicella vaccines for the control group. After vaccination, the volunteers and their families were followed for six months, in order to identify cases of acute respiratory infection (ARI) and to collect biological samples for testing with RT-PCR for diagnosis of influenza.

Eligibility criteria: Inclusion Criteria:

* older than six years of age;
* live in the study area;
* parent consent to participate, by signing the Informed Consent Form;
* no history of anaphilaxis or hipersensitivity to eggs or eggs proteins;
* no history no history anaphilaxis or hipersensitivity to any substances;
* no acute disease at the moment of vaccination
* no use of immunesupressant drugs;
* not have received any other vaccine in the previous six months;
* no participation in other clinical trial in the previous six months.

Exclusion Criteria:

* Any condition above mentioned.

Primary outcomes:
measure: Laboratory confirmed influenza
timeFrame: June 01, 2009 to November 30, 2009
Secondary outcomes:
measure: Acute Repiratory Infection (ARI)
timeFrame: 6 months
Other outcomes:
measure: Number of participantes with any adverse event as a measure of safety and tolerability
timeFrame: 30 days after vaccination
Locations:
city: Sao Paulo
country: Brazil
facility: Butantan Institute
Study officials:
affiliation: University of Sao Paulo
name: Expedito J Luna, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04098380: Small Versus Large Bite Closure of Emergency Midline Laparotomy
Official title: A Randomized Controlled Trial on Small Versus Large Bite Closure of Emergency Midline Laparotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Ventral
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 160
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In daily practice, midline laparotomy is an incision frequently performed by surgeons to achieve a rapid and wide access to the abdomen. However, incisional hernia stands as the most common complication following this type of incision, with an incidence reaching up to 20% and even higher in the case of emergency laparotomy.

A recent randomized controlled trial compared small bite sutures and large bite closure of elective midline laparotomy and reported a significant decrease of incisional hernia rate from 18% to 5.6% in favor of small-bite technique. These promising results were subsequently confirmed in a wide-scale multicenter double-blinded randomized trial, the STITCH study.

The investigators will conduct this randomized controlled trial to compare the small tissue bite (SB) technique and the large bite (LB) technique for closure of emergency midline laparotomy. The main outcome of the study will be the incidence of incisional hernia within one year after surgery.


Eligibility criteria: Inclusion Criteria:

* Adult patients of both sexes aging less than 70 years old

Exclusion Criteria:

* All procedures which will be performed on elective basis will be excluded
* patients who are pregnant.
* Patients on systemic steroid or chemotherapy
* patients with incisional hernia or fascial defect; and/or relaparotomy within 30-days of another surgical intervention.

Primary outcomes:
measure: Incidence of incisional hernia
timeFrame: 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh Emile, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02426580: Dietary Education Intervention Impact on Dietary Protein Intake in PD
Official title: Dietary Education Intervention With Wechat Model Will Impact on Dietary Protein Intake in Patient Treated With Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2015-04-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a prospective randomized controlled pilot trial/(a combined prospective and retrospective study). The investigators will use wechat intervening dietary protein intake in patients treated with peritoneal dialysis.

Detailed description: Malnutrition is highly prevalent in peritoneal dialysis (PD) patients, and protein malnutrition will adversely affect outcomes. The investigators develop a dietary education intervention for PD patients to improve fundamental food knowledge that will increase protein intake to target level of 1.2 g/kg of protein intake per day. In additional the dietary intervention will provide information about sodium, phosphorus, calcium intake. To more effectively deliver the intervention, the investigators explored a technology using social media in China called wechat. The purpose of this study is to test whether a dietary intervention can be more effective when delivered using wechat compared to a traditional patient education intervention delivered during routing clinical visits.

Eligibility criteria: Inclusion Criteria:

* 1. All patients followed at the PD center who successful completed training and have received treatment for at least 1 month.
* 2. The life expectancy will be more than one year.
* 3. All patients will provide written informed consent.

Exclusion Criteria:

* 1.the patients will be severe ill status and unlikely to survive for 12 months.

Primary outcomes:
measure: Normalized Protein Catabolic Rate (nPCR)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: