louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02102373: Evaluation of Two Different Diet Regimen Prior to Colonoscopy in Children
Official title: Clear Liquid vs Low-fiber Diet in Bowel Cleansing for Colonoscopy in Children: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children Prior to Colonoscopy
Keywords: colonoscopy, pediatric, preparation, diet
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 184
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Colonoscopy is a routinely performed procedure in children and adolescents. Proper visualization of the intestinal mucosa is highly dependent on the quality of the bowel preparation. European Society of Gastrointestinal Endoscopy (ESGE) emphasizes that the timing of bowel preparation is the key factor and recommends that the delay between the last dose of bowel preparation and colonoscopy should be minimized. Timing of bowel preparation prior to colonoscopy has not been studied in children population, yet. The diet regimen before colonoscopy is likely less important than the timing of bowel preparation, however may influence the well-being of children.


Eligibility criteria: Inclusion Criteria:

* Age 6-18 years
* Elective colonoscopy

Exclusion Criteria:

* Chronic renal, liver, or heart failure
* Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
* Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
* Any prior gastrointestinal surgery

Primary outcomes:
measure: Bowel preparation of the whole colon
timeFrame: in 15 minutes after colonoscopy
Secondary outcomes:
measure: Bowel preparation for colon sections
timeFrame: in 15 minutes after colonoscopy
measure: Duration of PEG taking
timeFrame: in 15 minutes after colonoscopy
measure: Time between the last dose of PEG and colonoscopy
timeFrame: in 15 minutes after colonoscopy
measure: Acceptability
timeFrame: in the first 6 hours after colonoscopy
measure: Tolerability
timeFrame: in the first 6 hours after colonoscopy
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Pediatric Gastroenterology and Nutrition
Study officials:
References:
citation: Mytyk A, Lazowska-Przeorek I, Karolewska-Bochenek K, Kakol D, Banasiuk M, Walkowiak J, Albrecht P, Banaszkiewicz A. Clear Liquid Versus Low-fibre Diet in Bowel Cleansing for Colonoscopy in Children: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2018 May;66(5):720-724. doi: 10.1097/MPG.0000000000001832.
Clinical trial NCT01616173: Analgesic Benefits of Perineural Versus Intravenous Dexamethasone in Patients Receiving Sciatic Nerve Block
Official title: The Effects of Perineural Versus Intravenous Dexamethasone on Sciatic Nerve Blockade Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fracture of Ankle
Keywords: Nerve Block
Anesthesia Recovery Period
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-06-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. The investigators are investigating the use of perineural dexamethasone together with local anesthetics can improve the quality of recovery for patients receiving sciatic nerve blocks for foot and ankle surgery.

Detailed description: Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. Perineural dexamethasone has been investigated as an adjuvant for brachial plexus nerve blocks but its effect on sciatic nerve block outcomes has yet to be determined. More importantly, it is not known whether the beneficial effect of perineural dexamethasone on analgesia duration leads to a better quality of surgical recovery. We hypothesized that perineural dexamethasone leads to a better quality of postsurgical recovery than intravenous dexamethasone or saline control.

Eligibility criteria: Inclusion Criteria:

* ASA 1-3 patients who are presenting for foot and ankle surgery and are candidates for a single injection sciatic nerve block to provide postoperative analgesia.
* Surgery confined to the foot and ankle.
* Patients aged 18-70 years.

Exclusion Criteria:

* ASA Classification of 4 or higher.
* Pre-existing neuropathy
* Coagulopathy
* Infection at the site
* Diabetes
* Non-English speaking or reading patients
* Systemic use of corticosteroids within 6 months of surgery
* Chronic opioid use
* Pregnancy
* Large (\>3cm) skin incision around the medial aspect of the foot
* Any other contra-indication to regional anesthesia

Primary outcomes:
measure: Quality of Recovery
timeFrame: 2 weeks
Secondary outcomes:
measure: Opioid Consumption
timeFrame: 2 weeks
measure: Pain Scores
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University, Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Rohit Rahangdale, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00385073: Assessing the Role of Exercise Intensity in Slowing Disease Progression in Early Parkinson's Disease
Official title: Assessing the Role of Exercise Intensity in Slowing Disease Progression in Early Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Lead sponsor: Austin Health
Sponsor class: OTHER_GOV
First posted: 2006-10-06
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Participants will complete a self-selected intensity of exercising over a 6 month period, with detailed clinical assessments at commencement and completion to determine the rate of progression of parkinsonism and gait abnormalities

Detailed description: Participants will complete a self-selected intensity of exercising over a 6 month period - including jogging, swimming and circuit training, with detailed clinical assessments at commencement and completion (including UPDRS, gaitrite lab study) to determine the rate of progression of parkinsonism and gait abnormalities

Eligibility criteria: Inclusion Criteria:

* Early Parkinson's Disease,
* Able to provide informed consent,
* able to complete exercise diaries for 6 months,
* no medications or on levo-dopa

Exclusion Criteria:

* Not on dopamine agonists,

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Royal Talbot Rehabilitation Centre
Study officials:
affiliation: Austin Health
name: mary m galea, PgD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04693273: Novel Decision Aid for Carpal Tunnel Patients
Official title: Novel Decision Aid for Carpal Tunnel Patients: Exploring Patient Preferences Between WALANT and Traditional Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome
Keywords: WALANT
Wide-Awake-Local-Anesthesia-no-Tourniquet
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are CTR candidates will be asked to participate in this study considering such patients are 18 years or older, comprehend and read English, and considering the participation depends on passing the orientation, concentration, and memory test.

Brief summary: A questionnaire will be given to patients who are considering undergoing hand surgery as a treatment for Carpal Tunnel Syndrome to help participants decide between two surgical options- Wide-Awake-Local-Anesthesia-no-Tourniquet (WALANT) and traditional open hand surgery. These patients will be asked to complete a pre-questionnaire knowledge test and a post-questionnaire knowledge test. the primary objective is to validate this questionnaire to be used by other orthopedic surgeons. This study will also reveal patient preference between these two surgical treatments for carpal tunnel syndrome.


Eligibility criteria: Inclusion Criteria:

* 18 years of older,
* CTS patients who are CTR candidates,
* Comprehend and understand English,
* Passed the Orientation-memory-concentration test done before the decision aid

Exclusion Criteria:

* Younger than 18 years of age,
* Non-CTS patients,
* Not CTR candidates,
* Do not comprehend or read English,
* Failed the Orientation-memory-concentration test done before the decision aid

Primary outcomes:
measure: Surgical Modality preference for CTR through questionnaire answers
timeFrame: Feb, 2020- Feb, 2021
Secondary outcomes:
measure: Patient Knowledge scores Before the decision aid use
timeFrame: Feb, 2020- Feb, 2021
measure: Patient knowledge scores after the decision aid use
timeFrame: Feb, 2020- Feb, 2021
measure: Decisional Conflict Score
timeFrame: Feb, 2020- Feb, 2021
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Charles S Day, M.D., M.B.A.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02757573: The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery
Official title: The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery - Assessment With Pulmonary Arterial Catheter and Transesophageal Echocardiography Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart; Decompensation, Right Ventricle
Echocardiography
Hypercapnia
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
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 aims of the study is to investigate the right ventricular responses to mild hypercarbia after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial catheter and transesophageal echocardiography.

Detailed description: The aims of the study is to investigate the right ventricular responses to mild hypercarbia after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial catheter and transesophageal echocardiography. Investigators hypothesize that induced mild hypercarbia (PaCO2 7.5 kPa) cause elevated mean pulmonary arterial pressure and pulmonary vascular resistance, and this reflect to the right ventricle, both volume and function. And this right ventricle effect could be noticed by echocardiography.

Eligibility criteria: Inclusion Criteria:

* scheduled mitral valve prolapse repair surgery
* able to give informed consent

Exclusion Criteria:

* preoperative right ventricular dysfunction or pulmonary hypertension
* significant tricuspid regurgitation
* congenital heart defect
* ventricular dyssynchrony or wide QRS-complex on ECG (\> 130 ms)
* prior myocardial infarction (within tree months) or pericardial constriction
* preoperative left ventricular (LV) dysfunction, i.e. LV ejection fraction under 40 %
* if the scheduled repair by plastic procedure has been converted to mitral valve replacement

Primary outcomes:
measure: Tricuspid annular plane systolic excursion (TAPSE)
timeFrame: Change from baseline TAPSE at hypercarbia (in approximately 30 min)
measure: Mean pulmonary artery pressure (MPAP)
timeFrame: Change from baseline MPAP at hypercarbia (in approximately 30 min)
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital Heart Center
Study officials:
affiliation: Tampere University Hospital
name: Kati Järvelä, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Kati Rautaneva, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03208673: Optive Brand For Day And Night Dry Eye Management
Official title: Optive Brand For Day And Night Dry Eye Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2017-07-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label study of Optive eyedrops and gel combination for day and night dry eye management


Eligibility criteria: Inclusion Criteria:

* OSDI score of ≥ 23
* Ocular comfort at waking \<65 on 100-point scale
* Conjunctival staining Grade ≥ 2 (scale 0 to 4) in at least one eye
* Use of eyedrops for the relief of dry eye symptoms for at least one month
* Best corrected visual acuity in each eye of at least 20/25
* Have normal eyes with the exception of the need for visual correction; subjects must be willing to cease contact lens wear for the duration of the study
* Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

Exclusion Criteria:

* Use of Benzalkonium Chloride (BAK) preserved eyedrops in the last month
* Use of Optive brand eyedrops in the last month
* Monocular participants (only one eye with functional vision).
* Contact lens wear during the study
* History of herpetic keratitis, ocular surgery or irregular cornea;
* Known pregnancy or lactation during the study period
* Participation in any clinical trial within 30 days of the enrollment visit

Primary outcomes:
measure: Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score
timeFrame: Change from baseline to (day 30 +/- 3 days)
measure: Measured Lissamine Green Bulbar Conjunctival Staining (mm2)
timeFrame: Change from baseline to (day 30 +/- 3 days)
Secondary outcomes:
measure: Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking
timeFrame: Baseline (day 0) to (day 30 +/- 3 days)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Ocular Technology Group - international
Study officials:
affiliation: Allergan
name: Sameena Haque
role: STUDY_DIRECTOR
References:
Clinical trial NCT04285073: Prospective, Multicenter, Non-randomized, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of e-PTFE Grafts Inner Surface-treated With Paclitaxel as an Access for Hemodialysis in Patients With End-stage Renal Disease.
Official title: Prospective, Multicenter, Non-randomized, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of e-PTFE Grafts Inner Surface-treated With Paclitaxel as an Access for Hemodialysis in Patients With End-stage Renal Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodialysis Access Failure
Keywords: hemodialysis
vascular access
arteriovenous graft
paclitaxel-eluting graft
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 20
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: OTHER

Brief summary: This prospective, multicenter, non-randomized, single-arm Clinical trial aims to evaluate the safety and effectiveness of the use of paclitaxel-coated arteriovenous graft (AVG) on the inner wall of ePTFE graft, which is designed to reduce neointimal hyperplasia that causes stenosis and thrombosis after implantation of AVG.

Detailed description: 1. Evaluation of safety Primary outcome: all adverse events occurring in the subject
2. Evaluation of effectiveness Primary outcome: AV graft primary patency Secondary outcome: AV graft secondary patency

Eligibility criteria: Inclusion Criteria:

* Adult male or female between the ages of 20 and 80
* Patients currently undergoing or scheduled for hemodialysis due to end-stage kidney disease.
* Patients who decided to receive AVG procedure in forearm due to inability to perform autologous arteriovenous fistula (AVF)
* Patients with a high risk of stenosis (neointimal hyperplasia) or thrombosis when artificial blood vessels were implanted

Exclusion Criteria:

* Pregnant or lactating women
* Patients who are currently diagnosed with malignant tumors and are receiving chemotherapy or radiotherapy
* Patients with life expectancy less than 12 months
* Patients expected to receive a kidney transplant during the trial
* Patients with current or suspected infection
* Acute psychiatric problems require treatment
* Patients who have inserted a catheter into an artery or vein in their upper limb for AVG procedure within the last 30 days
* Patients with coagulation disorder, platelet count \<50,000 / Ul
* Patients with a neutrophil count of less than 1,500 cells / mm3
* Patients judged to be unable to insert grafts by the operator

Primary outcomes:
measure: Adverse events
timeFrame: Up to 2 years after implantation of AVG
measure: Primary patency
timeFrame: at 6 months after implantation of AVG
Secondary outcomes:
measure: Secondary patency
timeFrame: Up to 2 years after implantation of AVG
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Dae Joong Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02235831: DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance
Official title: DAILIES® AquaComfort Plus® MF - Comparative Assessment of Visual Performance Using Objective Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Refractive Error
Keywords: DACP MF
DAILIES AquaComfort Plus® Multifocal
presbyopia
visual performance
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-09-10
Enrollment: 24
Sex: ALL
Minimum age (years): 41
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements.

Detailed description: In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 5±1 days before switching to the next assigned product.

Eligibility criteria: Inclusion Criteria:

* History of soft contact lens wear (hydrogel or silicone hydrogel) in both eyes during the past 3 months and able to wear lenses at least 8 hours a day, 5 days a week
* Spectacle add between +1.50 and +2.50 diopters (D) (inclusive)
* Requiring lenses within the power range of both study contact lenses to be fitted
* Cylinder, if present, less or equal to 0.50D in both eyes at Visit 1
* Vision correctable to 20/30 (0.2 logMAR) or better in each eye at distance
* Acceptable fit with both study contact lenses
* Willing to wear lenses every day or at least for a minimum of 5 days per week 6 hours per day, every day if possible
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Current multifocal contact lens wearer
* Current monovision wearer or failed attempt with monovision
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
* Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator
* Eye injury or surgery within 12 weeks immediately prior to enrollment in this trial
* Any moderate or severe ocular condition observed during the slitlamp examination at the enrollment visit
* History of herpetic keratitis, ocular surgery or irregular cornea
* Prior refractive surgery (e.g. LASIK, PRK, etc)
* Monocular (only 1 eye with functional vision) or fit with only 1 lens
* Habitually uncorrected anisometropia \>2.00D
* Clinically significant anisocoria
* Participation in any clinical trial within 30 days of the enrollment visit
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance
timeFrame: Day 5, each product
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Manager, EMEA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00627731: Oral Glucocorticosteroid in the Treatment of Severe Asthma Exacerbation in Hospitalized Patients
Official title: Phase 4, Randomized Study of Oral Glucocorticosteroid Administration in the Treatment of Acute Severe Asthma Exacerbation in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma Patients
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2008-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparison of oral prednisolone administration with intravenous methylprednisolone infusion in the treatment of acute asthma exacerbation in hospitalized patients. Oral glucocorticosteroids administration may be effective as intravenous high-dose methylprednisolone infusion.


Eligibility criteria: Inclusion Criteria:

* Asthma patients, who need hospitalized treatment, who do not respond with initial treatment including bronchodilator and IV methylprednisolone therapy

Exclusion Criteria:

* Need for incubation
* With severe complications
* Received systemic glucocorticosteroid therapy in the previous 4 weeks

Primary outcomes:
measure: Efficacy of oral prednisolone for the treatment of acute asthma
timeFrame: three-year
Secondary outcomes:
measure: The safety of oral prednisolone for the treatment of acute asthma
timeFrame: three-year
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
Study officials:
affiliation: Hamamatsu University
name: Kingo Chida, MD,PhD
role: STUDY_CHAIR
References: