louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04682522: Flagyl Microbiome in Crohn's Disease
Official title: Does the Microbiome Change With Flagyl Treatment After Ileocolic Resection for Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Crohn Disease
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized 1:1 study groups
Primary purpose: BASIC_SCIENCE

Brief summary: This study will compare the types of bacteria in the colon before and after colon resection surgery. The investigator will also compare standard post-operative antibiotic treatment to flagyl (metronidazole) treatment post-operatively to see if giving the antibiotic, decreases the incidence of return of Crohn's disease.

Detailed description: Participants who are scheduled for colon resection for Crohn's disease will be invited to take part in this randomized study. Participants will be randomized 1:1 to either Metronidazole 250 mg three times a day, starting after surgery, for three months, or the local usual standard of care after surgery, which may be a different antibiotic prescribed by the physician.

Participants will also provide a stool sample at the following time points: prior to surgery, the day of discharge, at their follow-up appointment (usually about two weeks after surgery), three months, and six months.

Participants will also be followed to determine their clinical outcome.

Eligibility criteria: Inclusion Criteria:

* 20-80 years old who is deemed an acceptable surgical candidate for ileocolic resection.

Exclusion Criteria:

* any patients that are dependent on total parenteral nutrition and unable to tolerate oral intake
* patients who will undergo resection but will have an ileostomy created
* patients on maintenance antibiotics for their disease

Primary outcomes:
measure: Change in bacteria in the gut
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University Surgical Associates
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Sandra Kavalukas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01611922: Optimization of Assessment and Grading for Lid Wiper Epitheliopathy
Official title: Optimization of Assessment and Grading for Lid Wiper Epitheliopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Keywords: eye
eyelid
contact lenses
dry eye disease
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-06-05
Enrollment: 57
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be identified and screened by the University of Waterloo in Ontario, Canada.

Brief summary: The purpose of this study is to assess eyelid margin staining, termed "lid wiper epitheliopathy" (LWE), in three populations. The hypothesis is LWE will be more prevalent in symptomatic contact lens wearers than non-symptomatic contact lens wearers and least prevalent in asymptomatic non-contact lens wearers.


Eligibility criteria: Inclusion Criteria:

* Has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Has had an ocular examination in the last two years;
* Has clear corneas and no active ocular disease;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Has any ocular disease;
* Has a systemic condition that may affect a study outcome variable;
* Is using any systemic or topical medications that may affect ocular health;
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
* Has undergone corneal refractive surgery;
* Currently wears contact lenses on an extended wear basis (overnight);
* Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: LWE-associated staining score
timeFrame: 3 minutes after dye instillation
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research, University of Waterloo
Study officials:
affiliation: Centre for Contact Lens Research, School of Optometry, University of Waterloo
name: Lyndon Jones, FCOptom, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00124722: A Study to Compare Different Intubating Doses of Zemuron in Pediatric and Adolescent Subjects Under General Anesthesia
Official title: A Randomized, Assessor-blind, Dose-ranging, Phase IIIB, Multicenter Trial Comparing the Intubating Conditions and Time Course of Block of Three Different Intubating Doses (0.45 mg/kg, 0.6 mg/kg, and 1.0 mg/kg) of Zemuron® in Pediatric and Adolescent Subjects Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-07-28
Enrollment: 207
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the time course of muscle relaxation after administration of three different single intravenous bolus doses of rocuronium bromide for intubation (insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation) in term neonates (birth to \<28 days old), infants (28 days to \<=3 months) and toddlers (\>3 months to \<=2 years), children (2 years to less than or equal to 11 years of age), and adolescents (\>11 years to less than or equal to 17 years of age).

Subjects in each of the age groups will be randomized to one of 3 Zemuron® doses: 0.45 mg/kg, 0.6 mg/kg, or 1.0 mg/kg.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects from birth up to 17 years of age who will be scheduled for surgery under general anesthesia.

Exclusion Criteria:

* Subjects whose parent(s) or legal guardian(s) are not willing to give written consent and where applicable, subjects who have not given appropriate assent to participate in the trial will not be allowed to enter.

Primary outcomes:
measure: Time to reappearance of T3 (time from end-administration of Zemuron to reappearance of the third twitch of a TOF stimulation)
timeFrame: during surgery
Secondary outcomes:
measure: Onset time, maximum block, time to reappearance of T1, Recovery to TOF 0.7, 0.8 and 0.9 and intubation score
timeFrame: during and after surgery
Other outcomes:
Locations:
Study officials:
References:
citation: Tirotta CF, Brandom B, Siddiqui MS, Ehlers M, Betzel J, Chen J-Y, De Bie J, Blobner M. Time Course of Rocuronium-Induced Neuromuscular Blockade in Pediatric Patients: A Phase III, Randomized, Dose-Response Study. J Anesthe Clin Res. 2012;3:189.
Clinical trial NCT00432822: Long-Term Tetrahydrobiopterin Treatment in PKU Patients of 0-18 Years - Study on Phenylalanine Tolerance and Safety
Official title: Double-Blind, Placebo Controlled, Multicentre Study With an Open Label Extension to Evaluate the Efficacy and Safety of Tetrahydrobiopterin (BH4) in Children and Adolescents With Hyperphenylalaninemia Caused by Phenylalanine Hydroxylase Deficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Phenylalanine Hydroxylase Deficiencies
Keywords: phenylketonuria
phenylalanine hydroxylase deficiency
BH4
responsive
tetrahydrobiopterin
newborns
infants
children
adolescents
Lead sponsor: Orphanetics Pharma Entwicklungs GmbH
Sponsor class: INDUSTRY
First posted: 2007-02-08
Enrollment: 50
Sex: ALL
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 the study is to confirm the efficacy and safety of BH4 in the treatment of hyperphenylalaninemia caused by phenylalanine hydroxylase deficiency in patients responsive to BH4. The primary objective is to assess the effect of BH4 on phenylalanine tolerance compared to placebo under optimal blood phenylalanine control and to demonstrate safety in 12 months long-term treatment. Additionally population PK will be assessed.


Eligibility criteria: Inclusion Criteria:

* Female and male patients, aged 0-18 years
* Phenylalanine-4-hydroxylase (PAH) deficiency shown by mutation analysis
* Blood phenylalanine concentration in the target range under dietary treatment
* Written consent of a parent or legal representative
* Assumed availability within the period of study participation
* Patients/parents willing and able to follow the recommended diet
* Use of an effective method of contraception in female patients of child bearing potential

Exclusion Criteria:

* BH4-deficiency due to genetic disorders in biosynthesis or recycling of BH4
* History or current evidence of poor diet compliance
* History or current evidence of clinically relevant allergic or idiosyncratic reactions to drugs or food
* History of allergic reactions to BH4 or its excipients
* Positive pregnancy test (ß-HCG in serum) and lactating females
* Participation in other drug trials within the last 30 days before start for the study

Primary outcomes:
measure: dietary phenylalanine tolerance
measure: safety
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre for Pediatrics and Adolescent Medicine, University of Freiburg, Freiburg, Germany
name: Andrea Superti-Furga, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muntau AC, Roschinger W, Habich M, Demmelmair H, Hoffmann B, Sommerhoff CP, Roscher AA. Tetrahydrobiopterin as an alternative treatment for mild phenylketonuria. N Engl J Med. 2002 Dec 26;347(26):2122-32. doi: 10.1056/NEJMoa021654.
Clinical trial NCT04531722: Intraoperative Brain Microdialysis to Assess Neuroinflammation in Epileptic Tissue Immediately Prior to Surgical Resection.
Official title: Intraoperative Brain Microdialysis to Assess Neuroinflammation in Epileptic Tissue Immediately Prior to Surgical Resection.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Epilepsy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We will establish intraoperative microdialysis in patients undergoing anterior temporal lobectomy for drug-resistant temporal lobe epilepsy. The human measurements will yield hypothesis-generating data and establish a methodological/logistical paradigm for future large-scale application of microdialysis in patients with drug refractory epilepsy.
Primary purpose: BASIC_SCIENCE

Brief summary: This research study will investigate the fluid from the area of the brain that is being removed during clinical epilepsy surgery. The goal is to analyze this fluid for inflammatory markers that can potentially help identify new strategies in the future to control seizures in individuals with epilepsy who fail to respond to currently available drugs.


Eligibility criteria: Inclusion Criteria

* Failure to respond to at least two trials of anti-seizure drugs with different mechanisms of action
* Normal MRI

Exclusion Criteria

* Active immunomodulatory therapy
* Autoimmune disorder
* Signs or symptoms consistent with comorbid infection
* Oncological comorbidity

Primary outcomes:
measure: Detection of analytes/protein
timeFrame: Through study completion, up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Charles Howe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01771822: Ibuprofen 5% Topical Gel CIPT
Official title: Cumulative Irritancy Patch Test (Cipt) of Ibuprofen 5% Topical Gel in Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: cumulative irritancy patch test (CIPT)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to cause irritation after repeated topical application to the healthy skin of human subjects under controlled conditions.


Eligibility criteria: Inclusion Criteria:

Healthy male and/or female subjects (to be confirmed by medical history) 18 years of age or older, female subjects of childbearing potential and males who are using an acceptable form of birth control, subjects who are free of any systemic or dermatologic disorder

Exclusion Criteria:

Have skin disease at the application site, not willing to stop use of systemic or topical analgesics, corticosteroids, or antihistamines, unwilling or unable to stop use of sunscreens, creams, or similar products on the back during the study

Primary outcomes:
measure: Assessment of local skin irritation at patch sites
timeFrame: Daily for 21 days, Days 2 through 22
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Days 1 through 22, + 28 days after last product administration
Other outcomes:
Locations:
city: Carlstadt
country: United States
facility: Pfizer Investigational Site
state: New Jersey
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04689022: Predictors of Treatment Failure Among Patients With Gunshot Wounds and Post-traumatic Stress Disorder
Official title: Predictors of Treatment Failure Among Patients With Gunshot Wounds and Post-traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gunshot Entry Wound
Keywords: Post-traumatic Stress Disorder
Lead sponsor: Bogomolets National Medical University
Sponsor class: OTHER
Collaborators: name: Bogomolets National Medical University
First posted: 2020-12-30
Enrollment: 218
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 218 patients completed the study. The Mississippi Scale for Combat-Related PTSD (M-PTSD) was used for assessment of the treatment outcome rate. The risk relation between treatment failure and factors was assessed by a univariate or multivariate logistic regression method, with the model accuracy measured by the AUC - Area under the ROC curve. The odds ratio (OR) was considered for the qualitative factor assessment.
Primary purpose: TREATMENT

Brief summary: The 82.1% treatment failure of post-traumatic stress disorder(PTSD), associated with gunshot wounds, is related to high incidence of chronic pain syndrome as well as resistance to the PTSD treatment. Defining treatment failure predictors among the PTSD patients with gunshot extremity wounds and the following therapy would improve treatment outcomes.

Detailed description: It has been noted that the PTSD in military combatants results from their direct participation in military actions. The study revealed that if a military combatant was wounded during the action operation, his emotional and subjective feelings will 100% lead to the PTSD. Other scientists state about the PTSD remote treatment failure in 80% of the military combatants. The study evidences about 82.1% of the PTSD m-related wounds treatment failure, which was essential for the subsequent studies. Some authors state about treatment effectiveness of psychopharmacological drugs and psychotherapy, which is rather questionable. Traumas and somatic diseases in the PTSD patients are known to accumulate their negative effects. So, definition of the PTSD treatment failure predictors may improve treatment outcomes.

Eligibility criteria: Inclusion Criteria:

* gunshot wounds
* post-traumatic stress disorder
* patients who need anesthesia

Exclusion Criteria:

* the patient has no post-traumatic stress disorder
* the patient has no gunshot wounds

Primary outcomes:
measure: Mississippi Scale for Combat-Related PTSD (M-PTSD)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National medical University named after O. O. Bogomolets, Kyiv, Ukraine
name: Iurii Kuchyn, MD
role: STUDY_CHAIR
References:
citation: Kuchyn IL, Horoshko VR. Predictors of treatment failure among patients with gunshot wounds and post-traumatic stress disorder. BMC Anesthesiol. 2021 Oct 30;21(1):263. doi: 10.1186/s12871-021-01482-8.
Clinical trial NCT05736822: The Impact of the COVID-19 Pandemic on the Patient in Need of an Intervention
Official title: The Impact of the COVID-19 Pandemic on the Patient in Need of an Intervention - COVID Surg III
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgical Procedures, Operative
COVID-19
SARS-CoV-2
Keywords: Specialties, Surgical
Surgery Department, Hospital
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-02-21
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (former) surgical, orthopedic, cardiological patients

Brief summary: Mixed-method observational study: the impact of pandemic related changes in healthcare on quality of life and experiences with healthcare in Dutch patients undergoing surgery or another intervention during the covid pandemic (2020-2021).

Phase 1: qualitative study to gain insight in relevant themes in Patient Reported Experiences Measures (PREMs) by conducting focus groups Phase 2: creating and validating a questionnaire based on themes identified in phase 1 Phase 3: questionnaire study among Dutch patients who underwent an intervention in 2020-2021 using the validated questionnaire of phase 2. The answers will be linked to data from national patients registries in surgery, cardiology, orthopedics and neurology.


Eligibility criteria: Inclusion Criteria:

* undergoing surgery or intervention in the Netherlands in 2020 or 2021

Exclusion Criteria:

* participation language restricted to Dutch

Primary outcomes:
measure: Patient Reported Experience Measures
timeFrame: 2020-2021
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
References:
Clinical trial NCT06900322: Impacts of a Physical Therapy Protocol on Motor Function in Children With Congenital Zika Syndrome
Official title: Structured and Specialized Physical Therapy: Does it Make a Difference for Children With Congenital Zika Syndrome?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Zika Syndrome
Lead sponsor: Instituto de Pesquisa Professor Joaquim Amorim Neto
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the effects of a specialized physiotherapy protocol aimed at the motor function of children with Congenital Zika Virus Syndrome. First, participants' anthropometric parameters (weight and length) and motor functions were assessed. After that participant were splited in two groups: Experimental group that uunderwent a one-hour daily protocol (5 times a week) of stimuli and handling based on the neuroevolutionary concept, and motor physical therapy with therapeutic garments (PediaSuit). On the other hand, the control group (CG) kept the therapeutic routine (conventional physical therapy).


Eligibility criteria: Inclusion Criteria:

* Children with confirmed CZS diagnosis by RT-PCR or presumed by imaging findings (CT or MRI \[or both\]), and according to the Center for Disease Control and Prevention criteria
* Children accompanied by the support center where the study was conducted.

Exclusion Criteria:

* Children who did not undergo assessments after the intervention
* Children those weighing \< 9,600 kg, with uncontrolled seizures, or orthopedic changes (e.g., hip subluxations or dysplasia, severe spasticity combined with joint contractures, and severe scoliosis \[Cobb angle \> 40°\]).

Primary outcomes:
measure: Gross Motor Function Measure (GMFM-88)
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Campina Grande
country: Brazil
facility: Instituto de Pesquisa Professor Joaquim Amorim Neto
state: Paraíba
Study officials:
References:
Clinical trial NCT06639022: Comparison of the Postoperative Analgesic Efficacy of SPSIPB and ESPB in Anterior Cervical Discectomy
Official title: Comparison of the Postoperative Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane Block and Erector Spinae Plane Block in Anterior Cervical Discectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cervical Discectomy
Peripheral Nerve Block
Pain Management
Keywords: Anterior Cervical Discectomy
Serratus Posterior Superior Intercostal Plane Block
Erector Spinae Plane Block
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-15
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anterior cervical discectomy is an operation performed for complaints of pain, numbness or loss of strength due to cervical disc disease. With this operation, pressure due to herniation on the upper neck area, spinal cord or nerve roots is relieved. It is performed by microscopic method from the front of the neck.

Nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications.

In this study; it was aimed to compare the analgesic effectiveness of serratus posterior superior intercostal plane block and erector spinae plane block, with each other and with the control group in the postoperative period in patients who underwent anterior cervical discectomy.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-80 years
* American Society of Anesthesiologists (ASA) score I-II-III
* Body Mass Index (BMI) between 18-30 kg/m2

Exclusion Criteria:

* Patients under 18 and over 80 years of age
* ASA score IV and above
* Patients with a history of bleeding diathesis
* BMI below 18 or above 30 kg/m2

Primary outcomes:
measure: Pain Scores
timeFrame: On the operation day
Secondary outcomes:
measure: Intraoperative remifentanil consumption Intraoperative opioid consumption
timeFrame: Intraoperative period
measure: Postoperative Tramadol Consumption
timeFrame: On the operation day
Other outcomes:
Locations:
city: Altındağ
country: Turkey
facility: Ankara Etlik City Hospital
state: Ankara
Study officials:
References: