louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00755560: Treatment of Asymptomatic Toxocariasis With Albendazole in Children
Official title: Treatment of Asymptomatic Toxocariasis With Albendazole in Children. A Prospective, Randomized, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Toxocariasis
Keywords: Toxocara
Pediatrics
Albendazole
eosinophilia
parasitology
pediatric clinical pharmacology
Lead sponsor: Hospital de Niños R. Gutierrez de Buenos Aires
Sponsor class: OTHER
First posted: 2008-09-19
Enrollment: 45
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate effectiveness of albendazole in the treatment of the asymptomatic infection with the parasite Toxocara in children. Treatment response is defined as a reduction in the number of eosinophils in blood. The study drug will be compared to placebo and randomly assigned in a double blind manner. Follow up will be prospective. 50 children (25 per group) will be enrolled in the study.


Eligibility criteria: Inclusion Criteria:

* Pediatric ambulatory patients with asymptomatic toxocariasis
* Children 2 - 15 years old
* Absolute eosinophil count \> 1100 / mm3
* Normal ophthalmoscopy

Exclusion Criteria:

* Treatment with a benzimidazole in the previous year
* Infection by other nematodes (Ascaris lumbricoides, strongyloides stercoralis, uncinarias, Trichuris trichuria)
* Symptomatic patients (prolonged fever, acute pneumonitis, hepatomegaly, splenomegaly, ocular compromise due to toxocara)
* Concomitant diseases
* Immunocompromised patients
* Altered liver or kidney function
* Pregnancy

Primary outcomes:
measure: Mean absolute reduction in eosinophil count from baseline
timeFrame: 12 months after treatment
Secondary outcomes:
measure: Reduction in eosinophil count in more than 60% from baseline
timeFrame: 1 year
measure: Incidence of adverse drug events
timeFrame: 3, 6, 9 and 12 months after treatment
measure: Mean absolute reduction in eosinophil count
timeFrame: 3, 6, 9 months after treatment
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
Study officials:
affiliation: Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
name: Jaime Altcheh, MD
role: STUDY_CHAIR
affiliation: Parasitology Division, Children's Hospital "R Gutierrez" of Buenos Aires
name: Hector Freilij, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01911676: Translational Neuroscience Optimization of GlyT1 Inhibitor
Official title: Translational Neuroscience Optimization of GlyT1 Inhibitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cognitive Impairments Associated With Schizophrenia
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2013-07-30
Enrollment: 71
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a Phase II, randomized, double-blind, placebo-controlled, cross-over POC study of stable patients with Schizophrenia or Schizoaffective disorder. The primary objective of this study is to test the efficacy of treatment with one of two does of a glycine transporter inhibitor (GlyT1I) combined with cognitive remediation to enhavce cognitive function. Subjects will be randomized to one of two doses of the glycine transporter inhibitor (GlyT1I) and placebo twice daily in addition to their antipsychotic medication for 2 treatment periods, each lasting a minimum of 5 weeks. Treatment periods will be separated by a washout period lasting approximately 3 weeks.


Eligibility criteria: Inclusion Criteria:

* 1) Males or females 21 to 65 years of age (inclusive).
* 2) Diagnosis of Schizophrenia or Schizoaffective Disorder
* 3) Able to provide written informed consent.
* 4) Only CYP2D6 extensive metabolizers.

Exclusion Criteria:

* 1) No ongoing acute medical issues
* 2) Clinically significant ECG abnormality
* 3) Blood donation within eight weeks of the start of the study
* 4) Current treatment with Clozapine

Primary outcomes:
measure: Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
timeFrame: Change from baseline in cognitive measures at approximately 5 weeks. Mean scores were calculated per time point for each arm.
Secondary outcomes:
measure: Alteration in Symptom Domain Scores and Event Related Potentials (ERPs) With PF-03463275
timeFrame: Change from Baseline at approximately 1 week
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University
name: Deepak C D'Souza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02861976: Screening in Trauma for Opioid Misuse Prevention
Official title: Screening in Trauma for Opioid Misuse Prevention (STOMP): Screen Development and Pilot Implementation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use Disorder
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of UW Trauma Inpatient Service with expected need for post discharge with outpatient opioid analgesia.

Brief summary: The current study seeks to begin the crucial work of creating effective protocols to prevent opioid misuse, addiction, and related complications by developing and pilot testing an opioid risk screening protocol at Wisconsin trauma centers.


Eligibility criteria: Inclusion Criteria:

* Inpatient victim of traumatic injury
* Expected need for post-discharge outpatient opioid analgesia
* English speaking
* Disposition to short-term rehabilitation facility is allowed

Exclusion Criteria:

* Disposition to a skilled nursing or long-term acute care facility
* Current active opioid use disorder or current active participation in a program of recovery for another substance use disorder

Primary outcomes:
measure: Opioid use disorder (CIDI-SAM) or opioid misuse (COMM) Opioid Use Disorder in 6 Months Post Traumatic Injury
timeFrame: 6 months subject participation
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Randall Brown, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown R, Deyo B, Riley C, Quanbeck A, Glass JE, Turpin R, Hetzel S, Nicholas C, Cruz M, Agarwal S. Screening in Trauma for Opioid Misuse Prevention (STOMP): study protocol for the development of an opioid risk screening tool for victims of injury. Addict Sci Clin Pract. 2017 Dec 4;12(1):28. doi: 10.1186/s13722-017-0097-6.
Clinical trial NCT03999476: Evaluation of the Efficacy of Ambu® aScope for Intubation in Cancer Tongue
Official title: Randomized- Single Blind Trial of Ambu Ascope and Fiberoptic in Severely Difficult Air Way Patient Having Posterior Third Fixed Tongue Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Intubation
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2019-06-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment
Primary purpose: OTHER

Brief summary: This study compares the ascope with standard fiberscope using the nasal route of intubation in patient having sever difficult airway (having posterior one third cancer tongue with fixed mobility)

Detailed description: patient will be allocated into two group according to the type of endoscope used group (F) fibro scope group and group (A) the ambu ascope group The timer will be started (T0), when touching the fiberscope or a scope. The standard fiberscope or a scope2 will be introduced through the nostril and advanced through the vocal cords, once carina identified the time will be recorded ( T1) When correct positioning of the trachea confirmed by detection of the end-tidal co2 curve on capnography (T2).

Eligibility criteria: Inclusion Criteria:

1. Adult patients of ASA physical status I and II who will be scheduled for posterior third fixed cancer tongue with severe difficult airway requiring naso-tracheal intubation
2. aged 18-70 years

Exclusion Criteria:

1. ASA 2 or 4
2. pregnant

Primary outcomes:
measure: time of successful intubation
timeFrame: 5 minutes
Secondary outcomes:
measure: quality of vision
timeFrame: 5 minutes
measure: incidence of complications
timeFrame: 15 minutes
measure: easiness of intubation
timeFrame: 5 minutes
measure: number of intubation trials
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alini Univeristy Hospital
state: Giza
Study officials:
affiliation: Cairo University
name: Ekramy M Abdelghafar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reeves DS, Brown NM. Mycobacterial contamination of fibreoptic bronchoscopes. J Hosp Infect. 1995 Jun;30 Suppl:531-6. doi: 10.1016/0195-6701(95)90059-4.
citation: Han DW, Shim YH, Shin CS, Lee YW, Lee JS, Ahn SW. Estimation of the length of the nares-vocal cord. Anesth Analg. 2005 May;100(5):1533-1535. doi: 10.1213/01.ANE.0000149900.68354.33.
citation: Marfin AG, Iqbal R, Mihm F, Popat MT, Scott SH, Pandit JJ. Determination of the site of tracheal tube impingement during nasotracheal fibreoptic intubation. Anaesthesia. 2006 Jul;61(7):646-50. doi: 10.1111/j.1365-2044.2006.04652.x.
Clinical trial NCT05866276: To Determine the Accuracy of SCreening for Occult REnal Disease (SCORED) Questionnaire for CKD Risk Among Asian Patients
Official title: A Real-World Multicentre Prospective Study to Determine the Accuracy of the SCORED (SCreening for Occult REnal Disease) Questionnaire for SCreening REnal Risk Early Against Nephropathy in Adult Population in Asia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-05-19
Enrollment: 1426
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal Adult Population in Asia

Brief summary: To determine the accuracy of SCreening for Occult REnal Disease (SCORED) questionnaire for CKD risk among Asian Patients


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: 28 February 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Perisai Husada
state: Jawa Barat
city: Surabaya
country: Indonesia
facility: Research Site
city: Ho Chi Minh City
country: Vietnam
facility: Nguyen Tri Phuong Hospital
Study officials:
References:
Clinical trial NCT01790776: Diagnosis of Urethral Stricture With Sono-urethrography vs Conventional Urethrography (SONO-URETHRA)
Official title: Diagnosis of Urethral Stricture With Sono-urethrography vs Conventional Urethrography: Evaluation of the Diagnostic Value and Evaluation of the Reduction of the Radiation Dose With Sono-urethrography (SONO-URETHRA)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Urethral Stricture Disease
Keywords: urethrography
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Conventional urethrography is the standard diagnostic evaluation for patients with a suspicion of urethral stricture. The radiation dose of this examination is 5-9 mSV. Sono-urethrography was introduced in 1988 (McAninch et al. , J Urol 1988); the diagnostic accuracy of sono-urethrography is equal compared to conventional urethrography, with even a better measurement of stricture length and degree of spongiofibrosis with sono-urethrography. However, sono-urethrography remained underused among urologists and radiologists.

Patients will be randomly assigned into two groups:

Group A: conventional urethrography Group B: sono-urethrography In case sono-urethrography is inconclusive or of poor quality, a conventional urethrography will be performed.

The radiation dose in the two groups will be measured. The stricture length and location will be recorded and compared with the perioperative findings in order to evaluate the diagnostic accuracy. The complications of the procedure(s) will be recorded with a questionnaire directly after and two weeks after the conventional or sono-urethrography.


Eligibility criteria: Inclusion Criteria:

* Patients with a suspicion of urethral stricture disease for which an indication of imaging of the urethra exists.

Exclusion Criteria:

* Transsexual patients.
* Patients with perineostomy.

Primary outcomes:
measure: Radiation dose during diagnostic intervention.
timeFrame: During urethrography.
Secondary outcomes:
measure: Diagnostic accuracy of sono-urethrography vs conventional urethrography.
timeFrame: Immediately and 2 weeks after urethrography
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Nicolaas Lumen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01350076: Liberal Versus Goal-directed Intraoperative Fluid Therapy in Pediatric Patients
Official title: Liberal VS Goal-directed Intraoperative Fluid Therapy in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Adverse Anesthesia Outcome
Keywords: intraoperative fluid
pediatric
goal directed therapy
pediatric with major abdominal surgery
ASA less than or equal to 3
Duration of surgery less than 2 hours
Body weight more than or equal to 15 kg
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-05-09
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are 1) to investigate the influence of different fluid regimen (Liberal regimen versus Goal directed therapy regimen) on postoperative outcome such as weight gain, delayed gut function recovery, pneumonia and 2) to ascertain the reliability of USCOM monitoring using serum lactate and base deficit as control parameters.

Detailed description: Liberal regimen = maintenance fluid(4/2/1) + deficit fluid + replacement of third space loss (\>,=10ml/kg/h) Goal directed therapy regimen = maintenance fluid + deficit fluid + fluid replaced by hemodynamic monitoring guided.

Eligibility criteria: Inclusion Criteria:

* Body weight \< 15 kg
* Under going major abdominal surgery such as tumor removal, gut obstruction, pull through, etc. under general anesthesia and invasive arterial pressure monitoring if justified
* ASA \< or = 3
* Duration of surgery \> or = 2 hours

Exclusion Criteria:

* Cardiopulmonary disease
* Renal insufficiency
* Intraoperative complications such as massive bleeding, severe hypotension, prolonged need for mandatory ventilation
* reoperation

Primary outcomes:
measure: Proportion of patients with 5% postoperative weight gain between control group and study group
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative morbidity
timeFrame: 4 days
measure: Amount of intraoperative fluid
timeFrame: 1 day
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Suwannee Suraseranivongse, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01251276: Hepatitis B Challenge Dose in Adults (V232-059-10)
Official title: A Study to Estimate the Immune Response Following a Challenge Dose in Adults (≥50 Years Old) Vaccinated With a Primary Series of an Hepatitis B Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-12-01
Enrollment: 204
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to describe the Seroprotection Rate (SPR) at least 2 years following completion of a primary series with a hepatitis B vaccine (Base Study V232-059, NCT00440531) and 1 month following a challenge dose with a Modified Process Hepatitis B vaccine.


Eligibility criteria: Inclusion Criteria:

* In general good health based on a medical history.
* Received 3 doses of an Hepatitis B vaccine in Base Study V232-059, NCT00440531 at least 2 years prior to enrollment in this study.

Exclusion Criteria:

* Known history of previous Hepatitis B infection.
* History of vaccination with any Hepatitis B vaccine within the last 2 years.
* History of febrile illness.
* Known or suspected hypersensitivity to any component of HBVaxPro.
* Receipt of medication / vaccine that may interfere with study assessments.
* Known or suspected immune impairment.
* Pregnant women and nursing mothers.

Primary outcomes:
measure: Percentage of Seroresponders Before and After the Challenge Vaccination
timeFrame: Predose (Day 1) and 1 month after challenge dose (Month 1)
Secondary outcomes:
measure: Percentage of Participants With One or More Adverse Experiences
timeFrame: Up to Day 15 after challenge dose
measure: Percentage of Participants Who Discontinued the Study Due to an Adverse Experience
timeFrame: Up to Month 7
measure: Percentage of Participants With One or More Injection-site Adverse Experiences
timeFrame: Up to Day 15 after challenge dose
measure: Percentage of Participants With One or More Systemic Adverse Experiences
timeFrame: Up to Day 15 after challenge dose
measure: Percentage of Participants With One or More Serious Adverse Experiences
timeFrame: Up to Month 1 after challenge dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Sharma R, Ahlm C, Ostergaard L, Dowell A, Tran C, Thomas S, Eymin C. Persistence of immunity in healthy adults aged >/= 50 years primed with a hepatitis B vaccine 3 years previously. Hum Vaccin Immunother. 2015;11(7):1709-16. doi: 10.1080/21645515.2015.1019187.
Clinical trial NCT03822676: Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula
Official title: Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula Before Segmental Pancreatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Fistula
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative pancreatic fistula (POPF) remains one of the most harmful complications after pancreatic resection. Some studies have indicated that endoscopic pancreatic stenting was effective in the treatment of POPF. However, the results of prospective RCTs for the prophylactic effect of pancreatic stent insertion against POPF were controversial. This single center prospective randomized trial was designed to compare the outcome after segmental pancreatectomy with prophylactic drainage stent versus no stent.


Eligibility criteria: Inclusion Criteria:

* All patients scheduled for elective segmental pancreatectomy

Exclusion Criteria:

* Subjects for whom ERCP procedures are contraindicated
* If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
* Age less than 18 year
* Emergency surgery
* Previous pancreatic surgery

Primary outcomes:
measure: Postoperative pancreatic fistula
timeFrame: from postoperative day 3 to 30
Secondary outcomes:
measure: Severity of pancreatic fistula
timeFrame: from postoperative day 3 to 30
measure: Length of stay
timeFrame: from postoperative day 1 to discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: