louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02658188: Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
Official title: Long-term Study - Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Restless Legs Syndrome
Keywords: Restless legs syndrome patients
ASP8825
XP13512
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-01-18
Enrollment: 182
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of ASP8825 (gabapentin enacarbil) for long-term treatment of restless legs syndrome patients.


Eligibility criteria: Inclusion Criteria:

* Patients who diagnosed with RLS according to the diagnostic criteria established by the International RLS Study Group
* International Restless Legs Syndrome Scale (IRLS) score ≥15 presence of RLS symptoms on ≥15 days per month and ≥4 days per week preceding inclusion in this study

Exclusion Criteria:

* Patients using dopamine agonists or gabapentin within 1 week before or any anti-RLS treatment within 2 weeks before the start of the pretreatment observation period
* Patients with an estimated creatinine clearance \<60 mL/min determined using the Cockcroft-Gault formula
* Pregnant or lactating women
* Individuals with serum ferritin \<20 ng/mL were also excluded from the trial
* Individuals with movement disorders and/or abnormal neurological findings

Primary outcomes:
measure: Change from baseline in IRLS score
timeFrame: Baseline to Week 52
measure: Safety assessed by Vital signs
timeFrame: Up to Week 52
measure: Safety assessed by Adverse Events
timeFrame: Up to Week 52
measure: Safety assessed by Laboratory tests
timeFrame: Up to Week 52
measure: Safety assessed by 12-lead-electrocardiogram
timeFrame: Up to Week 52
Secondary outcomes:
measure: Proportion of responders on ICGl of improvement
timeFrame: Up to Week 52
measure: Proportion of responders on PCGI of improvement
timeFrame: Up to Week 52
measure: Change from baseline in PSQI
timeFrame: Baseline to Week 52
measure: Change from baseline in SF-36v2
timeFrame: Baseline to Week 52
measure: Change from baseline in RLS-QOL
timeFrame: Baseline to Week 52
measure: Change from baseline in MOS sleep scale
timeFrame: Baseline to Week 52
measure: Plasma concentration of gabapentin
timeFrame: Week 12, 28 and 52
Other outcomes:
Locations:
city: Chiba
country: Japan
city: Fukuoka
country: Japan
city: Hokkaido
country: Japan
city: Hyogo
country: Japan
city: Kanagawa
country: Japan
city: Kyoto
country: Japan
city: Miyagi
country: Japan
city: Osaka
country: Japan
city: Saitama
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01716988: Pharmacokinetics of Micafungin in Critically Ill Patients
Official title: Pharmacokinetics of Micafungin in Critically Ill Patients With Invasive Candidiasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Invasive Candidiasis
Keywords: Micafungin
pharmacokinetics
invasive candidiasis
intensive care
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with invasive candidiasis admitted to an intensive care unit.

Brief summary: A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment success in ICU patients compared with non-ICU patients. It is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma concentration of a drug. The pharmacokinetic parameters of micafungin in critically ill patients are most likely different, but this has not been specifically studied.

The pharmacokinetic parameters of micafungin in critically ill patients will be established and plasma concentrations of micafungin will be correlated with disease severity.


Eligibility criteria: Inclusion Criteria:

* Treatment with micafungin.
* Admission to an ICU.
* Age ≥ 18 years.
* Invasive candidiasis.

Exclusion Criteria:

* Blood sampling not possible.

Primary outcomes:
measure: Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity.
timeFrame: 4 days
Secondary outcomes:
measure: Pharmacokinetic parameters of micafungin in ICU patients.
timeFrame: 4 days
measure: Time (in days) to culture conversion.
timeFrame: max 28 days
measure: Correlation of the plasma concentration of micafungin with response to treatment.
timeFrame: max 28 days
measure: Correlation of the plasma concentration of micafungin with inflammation parameters.
timeFrame: 4 days
measure: Area under the concentration-time curve (AUC)/minimal inhibitory concentration (MIC) ratio.
timeFrame: max 28 days
measure: Composing a pharmacokinetic model of micafungin in critically ill patients.
timeFrame: max 28 days
measure: Highest observed plasma concentration (Cmax)/minimal inhibitory concentration (MIC) ratio.
timeFrame: 28 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
citation: Boonstra JM, van der Elst KC, Veringa A, Jongedijk EM, Bruggemann RJ, Koster RA, Kampinga GA, Kosterink JG, van der Werf TS, Zijlstra JG, Touw DJ, Alffenaar JWC. Pharmacokinetic Properties of Micafungin in Critically Ill Patients Diagnosed with Invasive Candidiasis. Antimicrob Agents Chemother. 2017 Nov 22;61(12):e01398-17. doi: 10.1128/AAC.01398-17. Print 2017 Dec.
Clinical trial NCT02863588: Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis
Official title: Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Toxoplasmosis Infection
Genotype II
Ocular Toxoplasmosis With Recurrences
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Ocular toxoplasmosis (OT) is a major cause of visual impairment worldwide. OT is responsible for 30 to 50% of posterior uveitis. It is characterized by dormant infections that may reactivate without known reasons, causing severe irreversible visual loss. The overall recurrence rate of OT in Europe is greater than 80% for patients and may range from one episode to 11 episodes (1% of OT) in the most extreme cases. Current treatments do not reduce the risk of recurrences and the risk of toxoplasmosis recurrence cannot be predicted in these immunocompetent patients. These clinical and biological expression changes might be related to an individual genetic susceptibility of each patient. The advanced analysis of the entire genome now possible to consider the project.


Eligibility criteria: Inclusion Criteria:

* seropositive for Toxoplasma gondii (for patient and parents)
* Infection with genotype II (for patient and parents)
* ocular toxoplasmosis recurrences \>5 (patients only)

Exclusion Criteria:

* Parents seronegative for T. gondii infection
* Infection with others genotypes than type II

Primary outcomes:
measure: Highlighting of genetic mutations associated with the susceptibility to Toxoplasma gondii.severe eye recurrences. Mutation analysis will be done by exome sequencing of the subjects included in this study
timeFrame: This analysis will be performed on a blood sample taken in patients included in the inclusion visit
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital, Strasbourg, france
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Arnaud SAUER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05207488: Gastrointestinal And Metabolic Effects From a Prebiotic, Lifting, and Aerobic iNtervention
Official title: Gastrointestinal And Metabolic Effects From a Prebiotic, Lifting, and Aerobic iNtervention (GAMEPLAN)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Keywords: Gastrointestinal microbiota
Fructooligosaccharides
Exercise
Fiber
Prebiotic
Short-chain fatty acids
Glucose homeostasis
Body composition
Cognition
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomized, controlled trial with a 6-week intervention period with two groups: 1) Exercise + Prebiotic and 2) Exercise + Placebo.
Primary purpose: PREVENTION

Brief summary: This study aims to determine the independent and combined effects of prebiotic fiber supplementation and exercise on the gut microbiome and human health.


Eligibility criteria: Inclusion Criteria:

* BMI 18.5-45 kg/m2
* Without physician diagnosed gastrointestinal or metabolic diseases
* Sedentary (\< 30 minutes of moderate or high intensity exercise per week OR \< 20 aggregate Godin-Shepard Leisure Time Physical Activity Questionnaire (GSLTQ; GodinLeisure) score)
* Fully vaccinated against COVID-19

Exclusion Criteria:

* Fasting blood glucose \>126 mg/dL
* Blood pressure \>160/100 mm Hg
* Physician diagnosed metabolic or gastrointestinal diseases or constipation
* Heart conditions that may pose risk during exercise
* Taking oral hypoglycemic agents or insulin
* Pregnant, breastfeeding or postmenopausal
* Smoke or consume \> 2 alcoholic beverages/day, abuse drugs
* Have had \> 5% weight change in the past month or \> 10% change in the past year
* Have had any form of bariatric surgery or gallbladder removal
* Have taken antibiotics during the previous 3 months
* Unable to consume the experimental fiber

Primary outcomes:
measure: Changes in gastrointestinal microbiota composition
timeFrame: Baseline & 6-week mark
measure: Changes in gastrointestinal microbial-derived metabolite concentrations
timeFrame: Baseline & 6-week mark
Secondary outcomes:
measure: Changes in fasting glucose
timeFrame: Baseline & 6-week mark
measure: Changes in fasting insulin
timeFrame: Baseline & 6-week mark
measure: Changes in body composition
timeFrame: Baseline & 6-week mark
measure: Changes in body fat distribution
timeFrame: Baseline & 6-week mark
measure: Changes in cognition
timeFrame: Baseline & 6-week mark
Other outcomes:
measure: Changes in lipid profiles
timeFrame: Baseline & 6-week mark
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
References:
Clinical trial NCT05288088: Why Still in Neurosurgical Ward After Tumor Craniotomy?
Official title: Factors Associated With Prolonged In-hospital Stay After Elective Tumor Craniotomy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery--Complications
Brain Tumor
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 200
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: Patients scheduled for elective tumor craniotomy with the exception of stereotactic biopsy, pituitary surgery and laser interstitial thermal therapy.

Brief summary: The aim of this prospective observational study is to identify the specific reasons that prolong a hospital stay after elective tumor craniotomy. Optimal postoperative in-hospital stay is considered to be two days from surgery to discharge from the neurosurgical ward. However, a variable length of stay at a neurological department for follow-up of late recognized deficits of neurological consequences of the surgical procedure are common.

Detailed description: The concept of fast-track surgery and later enhanced recovery after surgery (ERAS) was first imputed in 1990s. Since then, ERAS protocols have been successfully adopted in many surgical fields, often with dramatic benefits for the patients. Length of hospital stay is one of the main questions addressed in many ERAS studies, as it by a simple approach address many of the complications encountered by the patients or the case flow in the perioperative period. Why patients have prolonged hospital stay after surgery has been investigated by Husted et al. in 2011 after hip and knee arthroplasty and P. Munk-Madsen et al. in 2019 after laparoscopic colorectal surgery. Both studies could isolate dominating factors prolonging hospital stay, some of them preventable. Existing length of stay studies on tumor craniotomy patients have focused on specific variables affecting hospital duration, but never explored the true cause of prolonged hospitalization.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective brain tumor craniotomy

Exclusion Criteria:

* Stereotactic biopsy, pituitary surgery and laser interstitial thermal therapy (LITT)

Primary outcomes:
measure: Hospital length of stay
timeFrame: Patients are followed for a maximum of 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Neuroanesthesiology, Rigshospitalet
Study officials:
affiliation: Department of Neuroanesthesiology, Rigshospitalet
name: Martin K Sørensen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03288688: Effect of an Exercise Program Designed for Orchestral Musicians
Official title: Effect of an Exercise Program Designed for Professional Orchestral Musicians on Performance-related Musculoskeletal Problems - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Disorder
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized clinical trial evaluating the effect of an exercise program designed specifically for orchestral musicians on performance-related musculoskeletal problems (PRMPs). Professional and conservatory-level orchestral musicians will be recruited. Half of the subjects will participate in an 11-week home exercise program and attend three group exercise sessions and an educational presentation on injury prevention, while the other half of the subjects will receive no intervention, and continue their usual activities.


Eligibility criteria: Inclusion Criteria:

* professional or freelance orchestral musician, or tertiary-level full-time music student majoring in an orchestral instrument
* able to commit to performing exercises 2 times per week over an 11-week period
* medical condition permitting participation in an exercise program (ie. no serious heart or lung condition that may be exacerbated by physical exertion)

Exclusion Criteria:

* presence of musculoskeletal injuries definitively non-related to musical practice or performance
* fewer than 15 hours per week playing their instrument
* corticosteroid infiltration in the 6 weeks preceding recruitment
* prescribed anti-inflammatory drugs or neurontin in the 3 weeks preceding recruitment

Primary outcomes:
measure: The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians (MPIIQM)
timeFrame: Baseline-11 weeks
Secondary outcomes:
measure: The Nordic Musculoskeletal Questionnaire (NMQ)
timeFrame: Baseline-11 weeks
measure: Global Rating of Change
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: CIRRIS
state: Quebec
Study officials:
References:
Clinical trial NCT01694888: Midwifery Students' Performance Before and After Teaching Fundamentals of Documentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Documentation Skill
Keywords: Students practice, Lecture; Nursing records; Nursing education; Midwifery
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 27
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Midwives are responsible for documenting and keeping care facts in midwifery departments. Inaccurate documentation or even minute error in reporting may lead to burdensome responsibility for midwives. This study has been conducted aimed to compare midwifery students' performance before and after teaching fundamentals of documentation. In this quasi-experimental study, 28 midwifery students were participated. Data were collected by a questionnaire including a. demographic data and b. Scenarios (1) and (2) of an imaginary patient with physician order and a checklist contain 11 elements of documentation


Eligibility criteria: Inclusion Criteria:

* midwifery students studying at mashhad school of nursing and midwifery

Exclusion Criteria:

* any other discipline

Primary outcomes:
measure: compare midwifery students' performance before and after teaching fundamentals of documentation using lecture method
timeFrame: up to one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02715388: Proof of Concept - Digital Electro-optical Surgical Platform as Replacement for Operational Microscopes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Detachment
Lead sponsor: Elbit Systems LTD
Sponsor class: INDUSTRY
First posted: 2016-03-22
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the use of Elbit's digital electro-optical systems for generating detailed high quality video imaging during surgery, and thus improving the surgeon's visualization, performance and outcome.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18.
* Pseudophakia patients with silicone oil in the vitreous cavity.
* Silicone oil density of 1500 centistoke or 5500 CS.
* Good corrected visual acuity (\> 6/10) in the second eye.
* Lack of additional ocular pathology that would reduce the quality of vision during surgery (corneal scar, Posterior Capsular Opacity, low transmission in the implantable lens, non-expanded pupil).

Exclusion Criteria:

* Additional ocular pathology that would reduce the quality of vision during surgery (corneal scar, Posterior Capsular Opacity, low transmission in the implantable lens, non-expanded pupil).
* The presence of heavy silicone oil (OXANE) in the vitreous cavity.
* Posterior segment pathology in the second eye.
* Special populations (children under the age of 18, pregnant women)

Primary outcomes:
measure: Field of view of GlasScope surgical microscope
timeFrame: Up to 3 days after surgery
measure: Depth of field of GlasScope surgical microscope
timeFrame: Up to 3 days after surgery
measure: 3D perception of GlasScope surgical microscope
timeFrame: Up to 3 days after surgery
Secondary outcomes:
measure: Surgeon fatigue and neck strain (questionnaire)
timeFrame: Up to 7 days after surgery
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Head of Retina Department, Sourasky Medical Center
name: Adiel Barak, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03399188: Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients
Official title: Fecal Microbiota Transplantation and Analysis of Fecal Microbiome in IBD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Inflammatory Bowel Diseases, Fecal microbiota transplantation, microbiome
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Inflammatory bowel disease patients in active stage.
Primary purpose: TREATMENT

Brief summary: Fecal microbiome of donor and recipient will be analyzed before and after fecal microbiota transplantation in IBD patients.

Detailed description: Fecal microbiota transplantation will be performed to the IBD patients, and microbial analysis will be done for donor and recipient feces. Fecal microbiota transplantation will be done twice via colonoscopy, with one month of duration. During the early stage of Fecal microbiota transplantation, recipient feces will be analyzed for the intestinal microbiota frequently.

Clinical outcome will be assessed 1month, 2month, 6month, and 1 year after the transplantation.

Relevance of intestinal microbial change and clinical outcome after transplantation and factors associated with successful clinical outcome will be investigated.

Eligibility criteria: Inclusion Criteria:

* 7 years old to 80 years old at start of trial
* Inflammatory bowel disease such as ulcerative colitis, Crohn's disease, and Behcet's colitis
* Patients who do not respond to the conventional treatments or who do not wish/not able to use one.
* Patients who agree to participate in the trial after thorough explanation
* Evidence of active disease

Exclusion Criteria:

* Patients whose CRP\<8, calprotectin\<200, and mucosal healing endoscopically (who are in stable state)
* Patients whose symptom is due to other disease than IBD

  _Patients with immunosuppressive disease
* Patients who are clinically unstable such as massive hemorrhage or perforation
* Patients with toxic megacolon, paralytic ileus, or symptomatic intestinal obstruction
* Absolute neutrophil count (ANC) \<1.5 \*10\^9/L (1500/mm3)
* Pregnant or under breast feeding
* Patients enrolled in other clinical trials

Primary outcomes:
measure: Clinical remission
timeFrame: 6months after the Second FMT
Secondary outcomes:
measure: Microbiome analysis by using relative abundance at phylum and genus level, beta diversity
timeFrame: Before, day 0~28 of 1st FMT, day 0~28, 60, 90, 180 of 2nd FMT
measure: Clinical response using disease activity index
timeFrame: 6 months after the Second FMT
measure: Endoscopic healing
timeFrame: 4 weeks after the First FMT
measure: Adverse events
timeFrame: 6 months after the Second FMT
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References: