louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01333553: Monitoring the Response of Port Wine Stain Birthmarks to Laser Therapy With Wide-field Functional Imaging Technologies
Official title: Monitoring the Response of Port Wine Stain Birthmarks to Laser Therapy With Wide-field
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PORT WINE STAIN
Keywords: birthmark
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2011-04-12
Enrollment: 69
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from an outpatient population with Port Wine Stain birthmark at Beckman Laser Institute and Medical Clinic, University of California, Irvine. Patients with Port Wine Stain birthmark will be candidates for participation.

Brief summary: The researcher develop non-invasive imaging modalities for assessment of port wine stain during laser therapy treatment of Port Wine Stain. The imaging modalities will be used to guide immediate retreatment of regions of persistent perfusion during the procedure.

Detailed description: The researcher can use imaging system operates by projecting low-power near-infrared structured light patterns on to the tissue of interest in a non-contact, reflection geometry and then capturing the reflectance with a camera.The system can image the depth-resolved optical properties of in-vivo tissues, allowing rapid, non-invasive visualization of sub-surface structures of Port Wine Stain.

Eligibility criteria: Inclusion Criteria:

* All minors, birth to 18 years of age or older with Port Wine Stain birthmark
* Ability to understand and carry out subject instructions
* Sign photograph release form

Exclusion Criteria:

* Inability to understand and/or carry out instructions
* Pregnant women
* Do not sign photograph release form

Primary outcomes:
measure: Image-guided surgery remove Port Wine Stain
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical clinic
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: Bernard Choi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05623553: Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population
Official title: Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaundice, Neonatal
Lead sponsor: Picterus AS
Sponsor class: INDUSTRY
Collaborators: name: Norwegian University of Science and Technology Faculty of Medicine and Health Sciences Department of Public Health and Nursing
name: Hospital Materno- Infantil de Irapuato
First posted: 2022-11-21
Enrollment: 174
Sex: ALL
Minimum age (years): 0
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This corss-sectional study aims to test the performance and accuracy of the Picterus JP screening device in newborns with different skin types.

Detailed description: A descriptive cross-sectional study among 174 newborns was carried out at Hospital Materno-Infantil de Irapuato in Mexico during July and August 2018.

The Picterus Calibration Card will be 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 will be used to collect digital images..

Eligibility criteria: Inclusion Criteria:

* Healthy newborns with or without signs of jaundice
* Gestational age \>35 weeks
* Age 0-14 days
* Birth weight \> 1500 g.
* Parents acceptance of their children to participate in the study.
* Newborn needing a blood test

Exclusion Criteria:

* Newborns showing signs or with diagnosis of inborn diseases
* Newborn transferred to pediatric ward for any treatment
* Newborns who had received phototherapy.

Primary outcomes:
measure: Enable high qualitative estimation of bilirubin levels in the blood of newborns using Picterus JP
timeFrame: 6 months
Secondary outcomes:
measure: Correlation with TsB
timeFrame: 1-2 hours
measure: Correlation with TcB
timeFrame: 5-10 minutes
measure: Correlation with visual assessment
timeFrame: 5-10 minutes
Other outcomes:
Locations:
city: Irapuato
country: Mexico
facility: Hospital Materno- Infantil de Irapuato
state: Guanajuato
Study officials:
affiliation: NTNU Faculty of Medicine and Health Sciences, Department of Public Health and Nursing
name: Elisabeth Darj, Prof, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03005353: Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.
Official title: Randomized Clinical Trial for Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infection, Fungal
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fungal infections have increased over the last two decades, largely because of the increasing size of the population at risk, including patients who are immunocompromised, broad-spectrum antibiotics and intravascular catheter users. Essential oils and other extracts of plants have evoked interest as sources of natural products. They have been shown to possess antibacterial, antifungal, antiviral, insecticidal and antioxidant properties. To the best of our knowledge, no study has examined the efficacy of cumin seed extract on relieving vulvovaginal candidiasis in vivo.


Eligibility criteria: Inclusion Criteria:

1. Women were 18-49 years old and were married;
2. They had not used antibiotics, immunosuppressive drugs, or vaginal drugs 14 days before the study;
3. They did not suffer from trichomonal vaginitis, bacterial vaginitis, or cervicitis based on direct smear;
4. Candidiasis culture was in agreement with clinical symptoms and patient's complaints.

Exclusion Criteria:

1. Pregnant and lactating women;
2. Those who had abnormal uterine bleeding;
3. Women with diabetes or autoimmune diseases;
4. Women refuse to participate in the study.

Primary outcomes:
measure: The percentage of patients with complete cure
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT06905353: Quality of Recovery in the Post-anesthesia Care Unit
Official title: Quality of Recovery in the Post-anesthesia Care Unit - Minimal Clinically Important Difference and Correlation with Postoperative Quality of Recovery One Day After Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Quality of Recovery
Postoperative Quality of Recovery in the Postanesthesia Care Unit
Keywords: postoperative care
patient-reported outcome
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients scheduled for elective non-cardiac surgery

Brief summary: This prospective observational study aims to identify the minimal clinically important difference of the QoR-PACU2 questionnaire. In addition, this study aims to assess the correlation between self-reported quality of postoperative recovery early after surgery in the post-anesthesia care unit and postoperative recovery on the first day after surgery.


Eligibility criteria: Inclusion Criteria:

* elective non-cardiac surgery
* expected duration of surgery ≥60 minutes
* postoperative stay at the post-anesthesia care unit

Exclusion Criteria:

* surgery or condition requiring postoperative treatment at an intensive care unit
* inability to give informed consent/requirement of a legal guardian

Primary outcomes:
measure: Minimal clinically important difference of QoR-PACU2
timeFrame: From preoperative assessment to the day of surgery in the post-anesthesia care unit
measure: correlation between quality of recovery at two time points of assessment
timeFrame: from the day of surgery to the first postoperative day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01566253: Oral Self Medication Versus IV Administration of Pain Killers After Caesarian Delivery
Official title: Comparison of a Patient Controlled Oral Administration (PCOA) of Analgesic Protocol With an IV Administration After Planned Caesarian Section : Monocentric, Randomised and Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Caesarian Section
Keywords: planned caesarian section, analgesic, PCOA
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Club anesthésie Reanimation Obstetricale
First posted: 2012-03-29
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: C-section deliveries are painful and need adequate analgesia. In the same time, mothers need early rehabilitation to take care of the baby.

Hypothesis: Early oral self administration of painkillers could be as effective as usual IV administration by nursing staff.

Purpose of the study: Evaluation of the efficacy of a program of self administration of painkillers postoperatively of C-section delivery.

Detailed description: Two Arms: PCOA group receiving oral self administered multimodal analgesic protocol and IV group receiving same multimodal analgesic protocol administered by nursing staff.

Eligibility criteria: Inclusion Criteria:

* planned caesarian section

Exclusion Criteria:

* delivery bleeding which requires general anaesthetic and other surgical treatment
* contraindication of the targetted anaesthetic because of hemostatis dysfunctionments
* Signed consent form
* under 18 years old, toxicomania
* do not french speacking
* allergia or contraindication to IMPs
* suffer from chronicle disease
* do not affiliate to a health protection
* do not want to cooperate with the medical staff

Primary outcomes:
measure: Median pain score during the first 48 hours (Verbal rating PAin Scale)
timeFrame: After 48 hours
Secondary outcomes:
measure: Onset of the first request of rescue analgesic drug
timeFrame: maximum 48 hours following the caesarian
Other outcomes:
Locations:
city: Montpellier
country: France
facility: university Hospital, Arnaud de Villeneuve, Gynecology department
Study officials:
affiliation: University Hosptial of Montpellier
name: Estelle Morau, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01828853: Maternal and Neonatal Outcomes After Membrane Sweeping
Official title: Maternal and Neonatal Outcomes After Membrane Sweeping
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Infection
Keywords: Membrane sweeping
Membrane stripping
Maternal outcomes
Neonatal outcomes
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women presenting to the Maternal-fetal unit who are 37+ weeks gestation

Brief summary: This study aim to estimate maternal and neonatal outcomes after membrane sweeping in different group of patients.

Detailed description: Sweeping of the membranes is a simple technique usually performed during vaginal examination, in order to initiate labour by increasing local production of prostaglandins.

Eligibility criteria: Inclusion Criteria:

* Women with a singleton pregnancy and confirmed cephalic presentation at or after 37 weeks of gestation who are candidate for vaginal delivery were eligible for the study

Exclusion Criteria:

* Women with a multiple pregnancy, nonreassuring cardiotocogram, meconium stained amniotic fluid, major fetal anomalies, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, or severe preeclampsia and signs of intrauterine infections were not eligible.
* women who are not candidates for vaginal delivery: placenta previa, breech presentation, planned repeat cesarean.

Primary outcomes:
measure: Neonatal sepsis
timeFrame: Neonates will be followed for the duration of hospital stay, an expected average of 2-3 days
Secondary outcomes:
measure: Neonatal infection
timeFrame: Neonates will be followed for the duration of hospital stay, an expected average of 2-3 days
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
References:
Clinical trial NCT04489953: Comparison of Treatment Failure Criteria in HIV-Infected Children in Uganda
Official title: Optimizing Antiretroviral Treatment Switch in HIV-Infected Ugandan Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: MU-JHU CARE
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 133
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main goal was to compare clinical and immunological versus clinical, immunological plus viral load criteria for switching to second-line ART by comparing 48 week treatment outcomes, including survival rates, viral suppression, failure to thrive, and AIDS-defining illnesses for treatment experienced children randomized to two switching criteria.

Detailed description: The overall goal of the study was aimed at determining whether the use of the current WHO criteria alone (clinical and immunologic) to define treatment failure as the trigger for switching to second-line antiretroviral therapy leads to poorer 6 month and 12 month treatment outcomes when compared to combining clinical and immunologic parameters with viral load (VL) monitoring.

In addition the study aimed at obtaining plasma samples from treatment experienced children, for future resistance testing. The results of this study may help guide WHO and national pediatric ART programs on the need for routine VL monitoring for children initiating HAART in resource limited settings, where virologic tests including resistance testing are not readily available or affordable.

Eligibility criteria: Inclusion Criteria:

* HIV-Infected Children, 1 year to 12 years
* ART experienced and enrolled in an existing treatment program that used clinical and immunologic criteria to monitor response to ART.

Exclusion Criteria:

* None

Primary outcomes:
measure: Criteria for switching HIV-Infected Children to second line
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kibalama Ssemambo P, Nalubega-Mboowa MG, Owora A, Serunjogi R, Kironde S, Nakabuye S, Ssozi F, Nannyonga M, Musoke P, Barlow-Mosha L. Virologic response of treatment experienced HIV-infected Ugandan children and adolescents on NNRTI based first-line regimen, previously monitored without viral load. BMC Pediatr. 2021 Mar 22;21(1):139. doi: 10.1186/s12887-021-02608-0.
Clinical trial NCT05402553: The Efficacy of Adjunctive Use of Ondansetron in Patients With Sepsis and Septic Shock
Official title: The Efficacy of Adjunctive Use of Ondansetron in Patients With Sepsis and Septic Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Sepsis
Septic Shock
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sepsis is a systemic inflammatory response that has deleterious effects and considered the leading cause of death in critically ill patients 1 . One of the hallmarks of severe sepsis is the progressive, injurious inflammatory response to infection, mediated by the excessive release of inflammatory mediators and consequently, associated with multiple organs damage 2 . Various studies have demonstrated that adverse outcomes in sepsis patients are closely related to the development of myocardial dysfunction 3 . The mortality of sepsis combined with cardiac functional insufficiency has increased significantly to 70%-90% 4 . Therefore, targeting cardiac insufficiency and heart injury may represent a novel treatment strategy. Several reports documented critical involvement of serotonin 5-hydroxytryptamine in the pathogenesis of sepsis. The aim of the current study is to evaluate the efficacy of ondansetron adjuvant use in patients with sepsis and septic shock.


Eligibility criteria: Inclusion Criteria:

male or female adult patients, aged 18 years or older with sepsis or septic shock after surgery according to the 2016 third international consensus definitions for sepsis and septic shock

Exclusion Criteria:

diagnosis of septic shock longer than 24 hours ago known or suspected disease with a strong indication or contraindication for the study drugs Pregnant and lactating women.

Primary outcomes:
measure: Sequential organ failure assessment (SOFA score)
timeFrame: 3 days post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
Study officials:
References:
Clinical trial NCT05966753: Describing Patient With DME, Their Patient Journey and Disease Progression
Official title: Observational Study on the Management, and Progression of Patients With Diabetic Macula Edema (DME)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 221004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is based on the patients attending a retinal specialist, included in the Vestrum Retinal specialist database. The study population will include adult patients with a DME diagnosis in at least one eye.

Brief summary: This study aims to characterize patients with diabetic macular edema (DME), their progression, the treatment received and associate the functional and physiological outcomes related to the treatment.


Eligibility criteria: Inclusion Criteria:

All patients ≥18 years, with a DME diagnosis in at least one eye, included in the Vestrum database identified during the study period (January 2015 to April 2023)

Exclusion Criteria:

Patients without the information of laterality will be excluded.

Primary outcomes:
measure: Change in visual acuity
timeFrame: From January 2015 to April 2023
measure: Progression to DME in the fellow eye
timeFrame: From January 2015 to April 2023
measure: Initial treatment of DME
timeFrame: From January 2015 to April 2023
measure: Central retinal thickness (CRT)
timeFrame: From January 2015 to April 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: CorEvitas HQ
state: Massachusetts
Study officials:
References:
Clinical trial NCT02016053: Incidence and Spectrum of Acute Kidney Injury in Cirrhotics and Assessment of New Biomarkers as Early Predictors of Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 500 patients with normal renal function. 200 patients with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be prospectively studied.

Brief summary: 500 patients with normal renal function will be prospectively studied and incidence, spectrum and natural history of AKI (Acute Kidney Injury) will be observed in them and in 200 patients with abnormal renal function fulfilling AKI (Acute Kidney Injury) criteria will be prospectively studied for 1 year. Also biomarkers will be studied and validated as early predictors of AKI (Acute Kidney Injury).


Eligibility criteria: Inclusion Criteria:

- Group A: 500 patients of cirrhosis with normal baseline renal function will be enrolled Group B : 200 patients who present with AKI (Acute Kidney Injury) will be enrolled

Exclusion Criteria:

* Age \< 18 or \> 70 years
* Preexisting Chronic Renal Disease
* Patients with obstructive uropathy.
* Cirrhosis with HCC (HepatoCellular Carcinoma).
* Advanced cardiopulmonary disease
* Pregnancy
* Patients with extrahepatic malignancy

Primary outcomes:
measure: The incidence , spectrum and natural history of Acute Kidney Injury in patients with cirrhosis
timeFrame: 1 Year
Secondary outcomes:
measure: To study predictive value of Cystatin C in comparison to serum creatinine as early predictor of development and outcome of AKI in a cohort of Cirrhotics.
timeFrame: 1 Years
measure: To study predictive value of Cystatin C to determine progression or resolution of Acute Kidney Injury
timeFrame: 1 Years
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT06554353: Cardiopulmonary Exercise Testing and Oscillometry for the Evaluation of Dyspnea
Official title: Cardiopulmonary Exercise Testing and Oscillometry for the Evaluation of Dyspnea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breathing, Mouth
Lung Function Decreased
Dyspnea
Shortness of Breath
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to fifty (50) human subjects will be recruited from the following University of Rochester locations: Mary Parkes Center for Asthma, Allergy, and Pulmonary Care, the Pulmonary Clinic at Strong Memorial Hospital, and The Pulmonary Clinic at Highland Hospital.

Brief summary: This study will determine if airway resistance to airflow and pressure, measured by Oscillometry, is associated with abnormal findings on Cardiopulmonary Exercise Testing in subjects who are experiencing shortness of breath.


Eligibility criteria: Inclusion Criteria:

* Willingness to perform breathing test
* Must be able to speak and understand English
* Referred for Cardiopulmonary Exercise Testing

Exclusion Criteria:

* Unable to provide consent or perform oscillometry test

Primary outcomes:
measure: Mean respiratory system resistance and reactance
timeFrame: Single measurement, approximately day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Highland Hospital
state: New York
Study officials:
References: