louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02338830: Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix
Official title: Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Premature Labour
Keywords: Twins
Preterm labor
Progesterone
Short cervix
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 182
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in asymptomatic twin pregnancies who have sonographic short cervix

Detailed description: Women with twin pregnancy with transvaginal sonographic cervical length of 20-25 mm at 20-24 weeks gestational age without symptoms, signs or other risk factors of preterm labor will be included in the study. All women will be randomly divided into two groups; one group (study group) received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 20-24 weeks gestational age (study group) and the other group received no treatment (control group)

Eligibility criteria: Inclusion Criteria:

* Women pregnant in dichorionic twins.
* Transvaginal sonographic cervical length is 20-25 mm at 20-24 weeks gestational age.
* No symptoms, signs or other risk factors for preterm labor.

Exclusion Criteria:

* Age \< 20 years or \> 35 years.
* Known allergy or contraindication (relative or absolute) to progesterone therapy.
* Pregnancy by in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI).
* Monochorionic twins.
* Known major fetal structural or chromosomal abnormality.
* Intrauterine death of one fetus or death of both fetuses.
* Fetal reduction in current pregnancy.
* Cervical cerclage in current pregnancy.
* Medical conditions that may lead to preterm delivery.
* Rupture of membranes.
* Vaginal bleeding.

Primary outcomes:
measure: Preterm labor before 34 weeks
timeFrame: Up to 34 weeks gestational age
Secondary outcomes:
measure: Neonatal respiratory distress syndrome (RDS)
timeFrame: At birth
measure: Early neonatal death (END).
timeFrame: One month after birth
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Obstetrics and Gynecology Department in Mansoura University Hospital
state: Dakahlia
city: Mansoura
country: Egypt
facility: Private practice settings
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Waleed El-refaie, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Mohamed S Abdelhafez, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Ahmed M Badawy, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT04174430: Clinical and Paraclinical Characteristics of Severe Bronchiolitis in Children From 2 Months to 12 Months at the Children's Hospital 1 in Ho Chi Minh City - Vietnam
Official title: Clinical and Paraclinical Characteristics of Severe Bronchiolitis in Children From 2 Months to 12 Months at the Children's Hospital 1 in Ho Chi Minh City - Vietnam
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epidemiological, Clinical, Paraclinical Characterictics of Severe Bronchiolitis
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 51
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children younger from 2-12 months are diagnosed broncholitis in children hospital 1

Brief summary: Goal: The aim of this study is to determine the epidemiological, clinical, paraclinical characteristics and treatment of severe bronchiolitis at the Children Hospital N01 in 2001-2002.

Materials and method: in this cross-sectional study, specimens of 51 patients with severe bronchiolitis at the Children Hospital N01 from March, 1 st 2001 to February, 28th 2002 are described and analyzed.


Eligibility criteria: Inclusion Criteria:

* children younger from 2-12 months present fever (usually ≤38.3ºC \[101ºF\]) ,cough, and respiratory distress (eg, increased respiratory rate, retractions, wheezing, crackles)
* preceded by a one- to three-day history of upper respiratory tract symptoms (eg, nasal congestion and/or discharge) \]
* Respiratory distress.

Exclusion Criteria:

* refusal to give informed consent
* mucus sample Barlett \<=0

Primary outcomes:
measure: Number of participants with Severe bronchiolitis at the Children Hospital N01
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Respiratory
state: District 10
Study officials:
affiliation: HoChiMinh Medical University
name: Thinh Tan Nguyen, professor
role: STUDY_DIRECTOR
References:
citation: Saez-Lopez E, Cristovao P, Costa I, Pechirra P, Conde P, Guiomar R; Portuguese Laboratory Network for the Diagnosis of Influenza Infection; Peres MJ, Viseu R, Lopes P, Soares V, Vale F, Fonseca P, Freitas L, Alves J, Pessanha MA, Toscano C, Mota-Vieira L, Veloso RC, Corte-Real R, Branquinho P, Pereira-Vaz J, Rodrigues F, Cunha M, Martins L, Mota P, Couto AR, Bruges-Armas J, Almeida S, Rodrigues D. Epidemiology and genetic variability of respiratory syncytial virus in Portugal, 2014-2018. J Clin Virol. 2019 Dec;121:104200. doi: 10.1016/j.jcv.2019.104200. Epub 2019 Oct 10.
Clinical trial NCT02638025: Anterior Segment Spectral-domain Optical Coherence Tomography in Patients With Closed Globe Injury
Official title: Anterior Segment Spectral-domain Optical Coherence Tomography in Patients With Closed Globe Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Injuries
Lead sponsor: Huizhou Municipal Central Hospital
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with closed globe injury were recruited, and all eyes of recruited patients had hyphema occupying at least 1/3rd of anterior chamber volume

Brief summary: This study use anterior segment spectral-domain optical coherence tomography (SD-OCT) to exam patients with closed globe injury, and compared with slit lamp examination. The results showed that OCT can identify features of closed globe injury that were otherwise not visible on slit lamp biomicroscopy.

Detailed description: The anterior segment architecture changes of closed globe injury patients include corneal damage, hyphema, angle recession and lens dislocation, which can be showed with OCT. OCT was superior to slit lamp biomicroscopy examination in detecting anterior segment architecture changes, especially in the presence of media opacities.

Eligibility criteria: Inclusion Criteria:

* patients with closed globe injury were recruited; had hyphema at least 1/3 of anterior chamber volume

Exclusion Criteria:

* can not cooperate with examination

Primary outcomes:
measure: anterior segment spectral-domain optical coherence tomography (SD-OCT) findings in patients with closed globe injury
timeFrame: within 24 hours after patients were admitted
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01140425: Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy Subjects
Official title: A Phase 1, Randomized, Multiple Dose, Placebo And Active Controlled, 4-Way Crossover Study To Evaluate The Effect Of A Multiple Oral Dose of PF-00232798 On Qt Intervals In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PF-00232798
CCR5
QT
QTc
pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: ViiV Healthcare
First posted: 2010-06-09
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the affect that PF-00232798 has on QT interval. A prolonged QT interval is a risk factor for arrhythmias.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 21 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
* 12-lead ECG demonstrating QTc \>450 msec at screening.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* History of orthostatic symptoms or orthostatic hypotension at screening.
* Pregnant or nursing females; females of childbearing potential.

Primary outcomes:
measure: QTc, using Fridericia's correction method (QTcF) at each time point of PF-00232798 and placebo on Day 7.
timeFrame: 7 days
Secondary outcomes:
measure: QTcF, or any other appropriate correction method at each postdose time point of moxifloxacin on Day 7
timeFrame: 7 days
measure: QTcB or any other appropriate correction method at each postdose time point of PF-00232798 and placebo on Day 7
timeFrame: 7 days
measure: Pharmacokinetic endpoints for PF-00232798 (Tmax, Cmax, Cτ, and AUClast)
timeFrame: 7 days
measure: Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments
timeFrame: 7 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05153525: Continuous Infusion Versus Intermittent Boluses of Cisatracurium in the Early Management of Pediatric ARDS
Official title: Continuous Infusion Versus Intermittent Boluses of Cisatracurium in the Early Management of Pediatric Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Respiratory Distress Syndrome, Pediatric
Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Keywords: Cisatracurium
PARDS
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this work is to compare continuous infusion vs on need intermittent boluses of Cisatracurium in the early management of pediatric acute respiratory distress syndrome

Detailed description: In the pediatric population, Acute respiratory distress syndrome (ARDS) has a high mortality rate of approximately 24%. In addition, there is a lack of high-quality data to guide the use of non-depolarizing neuromuscular blocking agents (NMBAs) in mechanically ventilated children. Hence, there is a need to evaluate its use in pediatrics.

Eligibility criteria: Inclusion Criteria:

1. Children with mild, moderate, and severe ARDS diagnosed according to criteria of Pediatric Acute Lung Injury Consensus Conference (PALICC) in 2015.
2. Children of both sexes aged from one month to 18 years.
3. Children diagnosed with ARDS \<48 hours before enrollment

Exclusion Criteria:

1. Continuous neuromuscular blockade at enrollment
2. Children on phenytoin and carbamazepine
3. Severe liver cirrhosis
4. High-risk medical illness (Bone marrow transplantation within the last one-year, Diffuse alveolar hemorrhage from vasculitis, Chronic respiratory failure, Burns \> 70% total body surface)
5. Previous hypersensitivity or anaphylactic reaction to Cisatracurium
6. Neuromuscular conditions that may potentiate neuromuscular blockade and/or impair effective spontaneous ventilation

Primary outcomes:
measure: Duration on mechanical ventilation
timeFrame: Up to 10 days
Secondary outcomes:
measure: Length of pediatric intensive care unit stay
timeFrame: 28 days
measure: Length of hospital stay
timeFrame: 28 days
measure: Pediatric intensive care unit acquired weakness
timeFrame: 28 days
measure: Organ failure free days to day 28
timeFrame: 28 days
measure: Ventilation follow-up
timeFrame: 7 days
measure: 28-day mortality
timeFrame: 28 days
measure: Serum Interleukin-8 assessment
timeFrame: 48 hours
measure: Mechanical ventilation complications follow-up
timeFrame: 28 days
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Gharbia
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Tanta University
name: Mohamed Khaled Talaat, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06791525: Tirbanibulin for Pediatric Warts
Official title: Single-arm, Open-label Study of Tirbanibulin 1% Ointment to Treat Warts on the Hands in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Warts Hand
Lead sponsor: The Skin Center Dermatology Group
Sponsor class: INDUSTRY
First posted: 2025-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Warts are common, benign skin lesions caused by the human papillomavirus (HPV). Treatment is challenging, particularly in the pediatric population, where standard modalities such as cryotherapy and intralesional immunotherapy are poorly tolerated. Existing topical treatments, such as imiquimod and 5-fluorouracil, have low efficacy and require prolonged use. Case reports suggest tirbanibulin ointment may provide an effective and well-tolerated alternative for pediatric warts. This study will evaluate the efficacy and safety of tirbanibulin ointment in treating pediatric hand warts.


Eligibility criteria: Inclusion Criteria:

1. Age 8-18
2. Subject and their legally authorized representative must be able to understand and be willing to adhere to all protocol requirements and voluntarily sign and date informed consent and assent for minors.
3. Subject is judged to be in good health as determined by the Principal Investigator, based upon the results of the screening assessments and medical history.
4. Diagnosis of warts on the hands
5. Wart count on the hands and 3-10

Exclusion Criteria:

1. Wart duration \>2 years.
2. More than 10 warts in non-hand areas.
3. Total wart surface area on the hands bigger than 100 cm2
4. Prior treatment failure with the following modalities:

1. intralesional immunotherapy 2. intralesional bleomycin, 5-fluorouracil, methotrexate 3. intralesional cidofovir 5. Any over the counter, prescription topical, or in-office procedural wart treatment within 6 weeks of baseline (Day 1) 6. Known immuno-suppressed state due to disease or medication, medical treatment o 7. Known allergy to any component of the IP 8. Any conditions that, in the Principal Investigator's opinion, may interfere with the course of the study

Primary outcomes:
measure: Resolution
timeFrame: 2 months aftre completion of 4 or less treatment cycles
Secondary outcomes:
Other outcomes:
Locations:
city: New City
country: United States
facility: The Skin Center Dermatology Group
state: New York
Study officials:
References:
Clinical trial NCT04473625: Stool Collection Sub-Study of Exact Sciences Protocol 2018-01
Official title: Stool Collection Sub-Study of Exact Sciences Protocol 2018-01: "Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Colo-rectal Cancer
Cancer
Keywords: Colorectal Cancer
Cologuard
Sample Collection
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
First posted: 2020-07-16
Enrollment: 291
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: Subjects will be men and women, 18 years of age or older, who enroll in Exact Sciences Protocol 2018-01. Approximately 450 subjects will be enrolled.

Brief summary: The primary objective of this sub-study is to obtain de-identified, clinically characterized, stool specimens from subjects with untreated solid tumors for research use in the development and validation of a stool-based test for colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Subject is currently enrolled in Exact Sciences Protocol 2018-01.
* Subject is willing and able to provide a stool sample.
* Subject understands the study procedures and is able to provide written informed consent to participate in the study.

Exclusion Criteria:

* Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the sub-study protocol, or put the person at undue risk.

Primary outcomes:
measure: Stool-based test for colorectal cancer
timeFrame: Point in time (one day) stool collection within 30 days of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Clinical Research Center, Inc.
state: Arizona
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Little Rock
country: United States
facility: CARTI Cancer Center
state: Arkansas
city: Greenbrae
country: United States
facility: Marin Cancer Care
state: California
city: Norwich
country: United States
facility: Easter Ct Hematology
state: Connecticut
city: Jacksonville
country: United States
facility: CSNF- Central Business Office
state: Florida
city: Saint Louis Park
country: United States
facility: Park Nicollet Institute - Oncology Research
state: Minnesota
city: Jackson
country: United States
facility: St. Dominic's Gynecologic Oncology
state: Mississippi
city: Greensboro
country: United States
facility: Cone Health Cancer Center
state: North Carolina
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Ogden
country: United States
facility: Community Cancer Trials of Utah
state: Utah
city: Charleston
country: United States
facility: CAMC Clinical Trials Center
state: West Virginia
Study officials:
References:
Clinical trial NCT05062525: Immune Response to COVID-19 Vaccine in Immunotherapy (IO) and Non-IO Treated Cancer Patients
Official title: Immune Response to COVID-19 Vaccine in Immunotherapy (IO) and Non-IO Treated Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Cancer
Keywords: COVID-19 Vaccine
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with solid malignancies treated with either immunotherapy or non-immunotherapy treatment who have received the SARS-CoV-2 vaccination.

Brief summary: Evaluation of antibody response against SARS-CoV-2 vaccination in patients treated with IO-treatment, in comparison with antibody titers in patients treated with non-IO treatment.

Detailed description: Blood samples will be analyzed to determine the magnitude of SARS-CoV-2 immunity in cancer patients treated with immunotherapy by quantifying antibodies and other tumor or blood-based biomarkers against SARS-CoV-2 epitopes following vaccination. We will also explore for potential development of autoantibodies and other blood-based biomarkers, following SARS-CoV-2 vaccination, and their correlation with clinical manifestation of IO related immune-related adverse events.

Eligibility criteria: Inclusion Criteria:

1. Patients with solid malignancies treated with either IO or non-IO treatment.
2. All categories of IO treatment allowed (immune-checkpoint inhibitors, bi-specific T cell engagers, cytokine agonists and others), as well as all categories of non-IO treatment (such as chemotherapy and targeted therapies). These can be given as part of standard of care or within participation in a clinical trial.
3. Patients are allowed to have any of the approved vaccines in Canada, such as Pfizer, Moderna, AstraZeneca or their approved combinations.
4. Patients must receive all appropriate doses of SARS-CoV-2 vaccination, as dictated by the respective vaccine schedules.

Exclusion Criteria:

* None

Primary outcomes:
measure: Concentration of SARS-CoV-2 antibodies
timeFrame: 15 months
measure: Number of immune-related adverse events
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
References: