louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02343562: Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis
Official title: Probiotics for Prophylaxis of Postoperative Hirschsprungs Associated Enterocolitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hirschsprung Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Probiotic Sachets
Primary purpose: PREVENTION

Brief summary: Hirschsprungs Associated Enterocolitis (HAEC) with incidence up to 30% postoperatively. The objective of the trial is to prevent postoperative HAEC by using Probiotics.

Detailed description: Randomised Controlled Study with two arms. All cases following up for post operative Hirschsprungs surgery are included in this study. First arm will receive a probiotics in the form of sachet for 6 months. Second arm will receive a multivitamin as placebo. Comparative analysis between the two groups for baseline and followup prevalence of Hirschsprungs associated enterocolitis.

Eligibility criteria: Inclusion Criteria:

* Hirschsprungs disease confirmed preoperative and postoperative specimen pathology

Exclusion Criteria:

* Other cases of Enterocolitis and constipation

Primary outcomes:
measure: Prevention of Hirschsprung's associated enterocolitis (HAEC)
timeFrame: 6 months
Secondary outcomes:
measure: Improvement of stooling pattern of postoperative Hirschsprung's cases
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Pediatric Hospital
Study officials:
affiliation: Cairo University
name: Mahmoud MA Elfiky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: El-Sawaf M, Siddiqui S, Mahmoud M, Drongowski R, Teitelbaum DH. Probiotic prophylaxis after pullthrough for Hirschsprung disease to reduce incidence of enterocolitis: a prospective, randomized, double-blind, placebo-controlled, multicenter trial. J Pediatr Surg. 2013 Jan;48(1):111-7. doi: 10.1016/j.jpedsurg.2012.10.028.
citation: Demehri, Farokh R., et al.
Clinical trial NCT00779662: The Prevalence of Rheumatic Heart Disease in School Children in Fiji
Official title: The Prevalence of Rheumatic Heart Disease in School Children in Fiji
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatic Heart Disease
Keywords: Rheumatic Heart Disease
Streptococcus
Fiji
Lead sponsor: Queensland Institute of Medical Research
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Menzies School of Health Research
name: University of Melbourne
First posted: 2008-10-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted in the Central Division of Fiji within a selection of up to16 primary schools located in the Korovou/Tailevu and Rewa/Nausori sub-divisions.

Brief summary: This study is an epidemiological observational cross-sectional study designed to estimate the prevalence of echocardiographically confirmed RHD in school children from 5-14 years of age in Fiji. The study will be conducted in the Central Division of Fiji within a selection of up to16 primary schools located in the Korovou/Tailevu and Rewa/Nausori sub-divisions. School children will be enrolled after informed consent has been obtained. A standard cardiac examination (auscultation) will be performed as part of the routine annual health check by both school nurses, who have attended a training workshop, and by a paediatrician. All children with or without murmur will have a screening echocardiogram performed at a subsequent visit. Children found to have possible, probable or definite RHD or other cardiac pathology on the screening echocardiogram, will have a full echocardiogram performed by the echocardiography technician at the time of the second study visit. They will all also be referred to a paediatric cardiologist for further investigation and management and monitoring . Cases of RHD will be referred to and followed up by the National Fiji RHD register based at CWMH in Suva.


Eligibility criteria: Inclusion Criteria:

* Informed consent will be obtained for all participants
* All children between the ages of 5-14 Years are eligible for the study.

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01412762: Measuring Patient Expectations for Thyroid Surgery
Official title: Measuring Patient Expectations for Thyroid Surgery: Development of a Patient-Reported Outcomes Instrument
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Thyroid Cancer
Keywords: Surgery
interview
11-087
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2011-08-09
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery for thyroid cancer will be recruited by the attending Head and Neck Surgeons and Research Study Assistants in the Head and Neck Clinic

Brief summary: The purpose of this study is to learn more about what patients undergoing surgery for thyroid cancer expect from their surgery. Your input may help us to better prepare and inform patients about their disease and its treatment.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* English speaking
* Patients with confirmed thyroid malignancy confirmed by preoperative fine needle biopsy (any stage) planned for surgical excision

Exclusion Criteria:

* Inability to speak or understand English
* Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability
* Prior thyroid surgery
* Prior radioactive iodine treatment, external beam radiation or chemotherapy

Primary outcomes:
measure: To establish a patient-reported outcomes tool for measuring preoperative expectations in patients undergoing surgery for thyroid cancer.
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Snehal Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05918562: Efficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep
Official title: Efficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colitis
Gastrointestinal Diseases
Pediatric Disorder
Pediatric Crohns Disease
Procedural Sequelae
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate if pediatric patients who are undergoing a bowel preparation in anticipation of a colonoscopy may be able to take in a low fiber diet instead of a standard, clear liquid diet, while still accomplishing an adequate bowel prep.


Eligibility criteria: Inclusion Criteria:

- All outpatients undergoing colonoscopy at our institution

Exclusion Criteria:

* Unstable medical condition
* Metabolic disease
* Inpatient status
* Requiring an emergency colonoscopy

Primary outcomes:
measure: Boston Bowel Prep Score
timeFrame: immediately after the colonoscopy
Secondary outcomes:
measure: Patient tolerance
timeFrame: immediately before the colonoscopy
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT00116662: An up to Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects
Official title: A Single-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 3 Times Per Week for up to 12 Weeks for the Treatment of Common Warts in Pediatric Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Warts
Keywords: Wart(s)
Common Wart(s)
Children
Pediatric
3M Pharmaceuticals
Resiquimod
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2005-07-01
Enrollment: 84
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of three different strengths of resiquimod gel applied to common wart(s) three times a week for up to twelve weeks.

A second purpose is to evaluate the safety of the drug.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of common wart(s)
* Ages between 3 to 11

Exclusion Criteria:

* Other types of wart(s), ie. plantar
* Currently participating in another clinical study
* Chronic viral hepatitis B or C

Primary outcomes:
measure: Clearance of treated common wart(s)
Secondary outcomes:
measure: Partial clearance of treated common wart(s)
measure: Wart recurrence
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Arkansas
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas
state: Arkansas
city: Newnan
country: United States
facility: Georgia
state: Georgia
city: Buffalo Grove
country: United States
facility: Illinois
state: Illinois
city: Lafayette
country: United States
facility: Indiana
state: Indiana
city: Wichita
country: United States
facility: Kansas
state: Kansas
city: Boston
country: United States
facility: Massachusetts
state: Massachusetts
city: St. Louis
country: United States
facility: Missouri
state: Missouri
city: Layton
country: United States
facility: Utah
state: Utah
city: Burlington
country: United States
facility: Vermont
state: Vermont
Study officials:
References:
Clinical trial NCT06394362: Comparison of DHT Duration in Geriatric Patients Using BIS Monitoring
Official title: Comparison of Deep Hypnotic Time Duration in Geriatric Patients Undergoing General Anesthesia With Additional Bispectral Index Monitoring Compared to Standard Monitoring at Cipto Mangunkusumo Hospital in 2023
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Hypnotic Time
Emergence Time
Geriatric Population
General Anesthesia
Keywords: bispectral index
deep hypnotic time
emergence time
mini mental state exam
geriatric population
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 44
Sex: ALL
Minimum age (years): 61
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Without adequate monitoring, administration of anesthetic agents can create unnecessary deeper anesthetic plane in geriatric population. This study aims to compare the duration of deep hypnotic time (DHT) in geriatric patients undergoing general anesthesia with additional BIS monitor compared to standard monitoring. This study was a randomized clinical trial involving 44 geriatric patients undergoing general anesthesia. Subjects are divided into two groups, one with additional BISTM monitor and the other with standard monitoring. Data acquired from BISTM will continually be recorded to be analyzed afterward


Eligibility criteria: Inclusion Criteria:

* Sampling was consecutively conducted on geriatric patients aged \>60 years undergoing general anesthesia for procedures lasting \>2 hours with ASA physical status 1-3 and willing to participate in the study

Exclusion Criteria:

* Exclusion criteria included intracranial procedures, unstable hemodynamic conditions, neurocognitive impairment, and if the patient was anticipated not to be extubated at the end of the surgical procedure. Patients could be excluded if the preoperative MMSE score was \<24, undergoing general anesthesia using a combination of ketamine and/or N20 agents, experiencing emergencies during surgery, and losing BIS data \>10% of the duration of the operation

Primary outcomes:
measure: Deep Hypnotic time duration with Bispectral Index Monitoring
timeFrame: 24 hours
Secondary outcomes:
measure: Mini Mental State Examination exam before and after operation in both control and experimental group
timeFrame: 24 hours
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Central National Hospital
Study officials:
References:
Clinical trial NCT01654991: Randomized Trial of Home Versus Clinic-Based STD Testing
Official title: A Randomized Trial of Home Versus Clinic-Based STD Testing Among Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chlamydia
Gonorrhea
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2012-08-01
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study randomizes St. Louis men to home-based STD screening or clinic-based STD screening. Home-based screening will be completed through the mail and clinic-based screening in a local clinical setting. We hypothesize that men randomized to home-based screening will be more likely to complete screening.


Eligibility criteria: Inclusion Criteria:

* Men
* Ages 18-45
* Residing in St. Louis City or County
* English-speaking

Exclusion Criteria:

-

Primary outcomes:
measure: Number of men who complete testing in each study arm
timeFrame: 12 weeks after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jeffrey F Peipert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Graseck AS, Secura GM, Allsworth JE, Madden T, Peipert JF. Home screening compared with clinic-based screening for sexually transmitted infections. Obstet Gynecol. 2010 Apr;115(4):745-752. doi: 10.1097/AOG.0b013e3181d4450d.
citation: Graseck AS, Secura GM, Allsworth JE, Madden T, Peipert JF. Home compared with clinic-based screening for sexually transmitted infections: a randomized controlled trial. Obstet Gynecol. 2010 Dec;116(6):1311-1318. doi: 10.1097/AOG.0b013e3181fae60d.
citation: Shih SL, Graseck AS, Secura GM, Peipert JF. Screening for sexually transmitted infections at home or in the clinic? Curr Opin Infect Dis. 2011 Feb;24(1):78-84. doi: 10.1097/QCO.0b013e32834204a8.
Clinical trial NCT04758091: Effect of Tourniquet Application on Optic Nerve Sheath Diameter
Official title: The Effect of Tourniquet Application on Optic Nerve Sheath Diameter and Cerebral Oxygenation During Lower Extremity Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Pressure Increase
Keywords: Optic Nerve Sheath Diameter
Tourniquet
Cerebral Oxygenation
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: lower extremity surgery with tourniquet

Brief summary: The aim of the study to investigate the effect of tourniquet application on optic nerve sheath diameter (ONSD) and cerebral oxygenation during lower extremity surgery.


Eligibility criteria: Inclusion Criteria:

* ASA I-II risk group over the age of 18
* Operation planned under general anesthesia
* Lower extremity surgery with a tourniquet
* Agreeing to volunteer for research with an informed consent form

Exclusion Criteria:

* Emergency surgical procedures
* neurological disease, carotid disease
* Previous intracranial or ocular surgery
* Neurological symptoms
* cerebral edema, high IntraCranial Pressure
* Presence of glaucoma
* Body mass index (BMI)\> 35
* Uncontrolled hypertension
* Diabetic retinopathy
* anemia
* coronary artery disease
* peripheral artery disease

Primary outcomes:
measure: optic nerve diameter
timeFrame: during the surgery
measure: regional cerebral oxgenation
timeFrame: during the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University Medicine Faculty
state: Kozlu
Study officials:
References:
Clinical trial NCT05525091: Neoneur Feeding System Functionality in the Clinic
Official title: Neoneur Feeding System Functionality in the Clinic - Investigating Assessment of Quantifying Feeding Functionality in Premature and Cardiac Surgery Neonates in Comparison to Dr. Medoff-Cooper's Past Research
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Feeding Patterns
Feeding; Difficult, Newborn
Feeding Disorder Neonatal
Lead sponsor: Neoneur LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
name: Children's Hospital of Philadelphia
First posted: 2022-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prospective data collection using the Neoneur Feeding System to demonstrate device functionality, correlation to historic data, and prepare for a more extensive phase II SBIR trial

Detailed description: The consented infant's assigned Speech Language Pathologist will use the Neoneur Feeding System 2-3 times a week from initiation of oral feeding until discharge, if oral feeding is prescribed. It can be used either as a special consult, or during routine care. The feeding is performed by the Speech Language Pathologist assigned to the infant. There will be no change in the infant's feeding plan. For infants consented to participate in the study, their feeding will include the Neoneur feeding system inserted between the nipple and bottle. When the Neoneur is inserted, it will capture both the suck and swallow changes (oral cavity pressure), and respiration (temperature changes) patterns.

Eligibility criteria: Inclusion Criteria:

* Preterm infants: requiring tube assisted feeding while in the NICU, gestational age at birth =\<34 week, extubated by term
* Infants with CHD: requiring surgery during the first month of life, gestational age \> 37 weeks

Exclusion Criteria:

* Premature infants: craniofacial anomalies, infants with grade IV intraventricular hemorrhage, apgar \< 5 at 5 minutes, short gut syndrome, history of NEC
* Infants with CHD: no other congenital anomalies, no history of major neurologic insult , listed for heart transplant, history of ECMO, intubated for \> 4 weeks, requiring additional surgery

Primary outcomes:
measure: Maturation
timeFrame: 6 weeks of data collection
measure: Telehealth functionality
timeFrame: 6 months
Secondary outcomes:
measure: Respiratory
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Pennsylvania
name: Barbara Medoff-Cooper, MSN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01060891: Population Pharmacokinetic Study of Colistin in Patients Infected With Multiresistant Gram-negative Bacteria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gram-negative Bacteria
Keywords: patients infected with with multiresistant gram-negative bacteria
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Nosocomial infections have become a major health problem. They induced important use of antibiotics which is a preponderant factor for the development of bacterial resistance. The multi-resistance to antibiotics affects primarily Gram-negative bacteria. Some strains (as Acinetobacter or Pseudomonas) have become resistant to almost all antibiotics currently available, and the use of old molecules as Colistin may be the only alternative. However, there are few reliable data about Colistin and its PK characteristics. These data are essential to optimize its administration. The aim of the present study is to evaluate the pharmacokinetics of Colistin and its prodrug, colistimethate (CMS) after intravenous administration of Colistimethate alone or combined with inhaled Colistin in severely ill patients infected with multiresistant gram-negative bacteria


Eligibility criteria: Inclusion Criteria:

* Age: 18 to 85 years
* Patients with nosocomial infection justifying Colistin.

Exclusion Criteria:

* Patients who received Colistin within 7 days prior to its inclusion, whatever the dosage or the route of administration
* Known hypersensitivity to Colistin or products of the polymyxin family
* Personal and family history for myasthenia
* Positive serology for HBV, HCV and HIV
* Positive pregnancy test or currently lactating

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Poitiers University Hospital - 2 rue de la Milétrie
Study officials:
References:
citation: Boisson M, Gregoire N, Cormier M, Gobin P, Marchand S, Couet W, Mimoz O. Pharmacokinetics of nebulized colistin methanesulfonate in critically ill patients. J Antimicrob Chemother. 2017 Sep 1;72(9):2607-2612. doi: 10.1093/jac/dkx167.