louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01384227: Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study
Official title: Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Barrett's Esophagus
Keywords: Barrett's esophagus
in vivo imaging
image guide microscope
Lead sponsor: Anandasabapathy, Sharmila, M.D.
Sponsor class: INDIV
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2011-06-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of barrett's esophagus in vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is a pilot study of an novel technology, a miniaturized microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This is an exploratory, not a comparative, study designed to evaluate the feasibility of using this instrument in Barrett's esophagus.


Eligibility criteria: Inclusion Criteria:

* Barrett's without dysplasia
* Barrett's with dysplasia
* Esophageal Adenocarcinoma

Exclusion Criteria:

* Subjects unfit for standard upper endoscopy
* Subjects currently receiving chemo or radiation treatment
* Subject currently receiving PDT or ablation

Primary outcomes:
measure: To determine whether tissue is neoplastic or non-neoplastic
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
affiliation: Mt. Sinai School of Medicine
name: Sharmila Anandasabapathy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shin D, Lee MH, Polydorides AD, Pierce MC, Vila PM, Parikh ND, Rosen DG, Anandasabapathy S, Richards-Kortum RR. Quantitative analysis of high-resolution microendoscopic images for diagnosis of neoplasia in patients with Barrett's esophagus. Gastrointest Endosc. 2016 Jan;83(1):107-14. doi: 10.1016/j.gie.2015.06.045. Epub 2015 Aug 5.
Clinical trial NCT01163760: Clinical Evaluation of Two Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Singapore Polytechnic University
name: Visioncare Research Ltd.
First posted: 2010-07-16
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study seeks to evaluate the clinical performance of two daily disposable contact lenses.


Eligibility criteria: Inclusion Criteria:

* Be between 21 and 39 years of age.
* Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
* Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
* Require a visual correction in both eyes (monovision allowed but no monofit).
* Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.
* Astigmatism of 1.00D or less in both eyes.
* Be able to wear the lens powers available for this study.
* Be correctable to a visual acuity of 20/30 or better in each eye.
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

  * No amblyopia.
  * No evidence of lid abnormality or infection.
  * No conjunctival abnormality or infection.
  * No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities).
  * No other active ocular disease.

Exclusion Criteria:

* Requires concurrent ocular medication.
* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
* Diabetic.
* Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* Extended lens wear in last 3 months.
* PMMA or RGP lens wear in the previous 8 weeks.
* Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
* Abnormal lacrimal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Keratoconus or other corneal irregularity.
* Pregnancy, lactating or planning a pregnancy at the time of enrollment.
* Participation in any concurrent clinical trial or in last 60 days."

Primary outcomes:
measure: Lens Comfort
timeFrame: 1-week follow-up
Secondary outcomes:
measure: Comfort Throughout the Whole Day
timeFrame: 1-week follow-up
Other outcomes:
measure: Comfort While Working on Computer
timeFrame: 1-week-follow-up
Locations:
city: Singapore
country: Singapore
Study officials:
References:
Clinical trial NCT01280760: Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV)
Official title: Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weaning Period
Lead sponsor: Pierre and Marie Curie University
Sponsor class: OTHER
First posted: 2011-01-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NIV required on post extubation period

Brief summary: Non-invasive ventilation (NIV) has been proposed to reduce the incidence of ventilatory dysfunction following mechanical ventilation weaning. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non-invasive ventilation and induces air leaks. The presence of leaks at the patient-mask interface can increase the risk of patient-ventilator asynchrony, which in turn leads to increase patient discomfort. Neurally adjusted ventilatory assist (NAVA)could contribute to decreasing asynchrony. Its principle is to record the diaphragmatic electrical activity and to control the ventilator. The investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies in NIV


Eligibility criteria: Inclusion Criteria:

Patients with increased risk of post-extubation ventilatory dysfunction following invasive mechanical ventilation weaning.

Exclusion Criteria:

* Contra-indication to non-invasive ventilation
* Pregnancy

Primary outcomes:
measure: Triggering delay
timeFrame: Every inspiration, for 10 minutes
Secondary outcomes:
measure: Cycling off delay
timeFrame: Every inspiration, for 10 minutes
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpétrière, Department of intensive care and pneumology
Study officials:
References:
citation: Schmidt M, Dres M, Raux M, Deslandes-Boutmy E, Kindler F, Mayaux J, Similowski T, Demoule A. Neurally adjusted ventilatory assist improves patient-ventilator interaction during postextubation prophylactic noninvasive ventilation. Crit Care Med. 2012 Jun;40(6):1738-44. doi: 10.1097/CCM.0b013e3182451f77.
Clinical trial NCT03238560: The Population Pharmacokinetics of Montelukast in Infants and Children
Official title: Population Pharmacokinetics of Montelukast in Infants and Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients are cared in the department of pediatric respiratory at Shandong Provincial Qianfoshan Hospital, Jinan, China.

Brief summary: The investigators' aim was to evaluate the population pharmacokinetics of montelukast in infants and children and define the appropriate dose in order to optimize Montelukast treatment in this vulnerable population.


Eligibility criteria: Inclusion Criteria:

* patients have been diagnosed with asthma; age range: 1 month to 12 years old; montelukast used as part of regular treatment.

Exclusion Criteria:

* expected survival time less than the treatment cycle; patients with other factors that researcher considers unsuitable for inclusion.

Primary outcomes:
measure: plasma concentration
timeFrame: 3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration
measure: bronchoalveolar lavage fluid(BALF)
timeFrame: Procedure (When the patient underwent fiberoptic bronchoscopy)
Secondary outcomes:
Other outcomes:
Locations:
city: Ji'nan
country: China
facility: Shandong Provincial Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: Shandong University
name: Wei Zhao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01946360: Role of 13C Methacetin Breath Test in Predicting Prognosis Among Patients With Acute or Acute on Chronic Liver Failure (ACLF).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Liver Failure
Acute on Chronic Liver Failure
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Blood will be collected after venepuncture from all patients for complete blood counts, Serum bilirubin (direct and indirect), aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, prothrombin time and INR, urea, creatinine, sodium, potassium, serum total protein and albumin, within 24 hours after admission and twice a week there after or as and when needed.

Time line for blood tests and evaluation of clinical parameters \& 13C-MBT

For ALF patients:

On days 0, 1, 3, and 7

For ACLF patients:

On days 0, 7 (week 1), 14(week 2), 28 (weeks 4)

Blood tests would include:

Serum bilirubin (total and direct), aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyltransferase, Serum proteins (total and albumin), prothrombin time \& international normalized ratio (INR), Serum urea and creatinine, serum electrolytes, arterial ammonia and arterial blood gas analysis.


Eligibility criteria: Inclusion Criteria:

- All patients presenting with acute liver failure and acute on chronic liver failure (between 18 - 70 years of age) to Institute of Liver \& Biliary Sciences (ILBS), New Delhi, India.

Exclusion Criteria:

1. Patients with significant co-morbid illnesses such as cardiovascular or respiratory or intrinsic renal diseases which by themselves may have a bearing on the outcome.
2. Patients with previous intestinal bypass surgery for morbid obesity
3. Patients with extensive small bowel resection
4. Patients currently receiving total parenteral nutrition
5. Pregnant women
6. Patients with history of allergy to paracetamol
7. Patients on steroids or anti-fungal agents
8. Patients in encephalopathy
9. Patients unwilling to participate in the protocol
10. Patients on medications which can alter the activity of CYP 1A2 enzymes such as corticosteroids, amiodarone, tetracycline, niacin, valproic acid, methotrexate, stavudine and zidovudine.

Primary outcomes:
measure: Survival or Transplantation for Acute Liver Failure (ALF).
timeFrame: 2 years
Secondary outcomes:
measure: Mortality or Transplantation for Acute on Chronic Liver Failure (ACLF) patients.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver & Biliary Sciences.
name: Dr Ashok Choudhary, DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03807960: Information for Patient Controlled Analgesia Device
Official title: The Effect of Visual and Written Information Tools on Patient Controlled Analgesia Device Usage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Care
Hysterectomy
Health Communication
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
Collaborators: name: Tokat Gaziosmanpasa University
First posted: 2019-01-17
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is aimed to show the effect of information method on properly usage of the patient controlled analgesia(PCA) device

Detailed description: Postoperative pain is still a challenge for anesthesiologist. Patient controlled analgesia is an effective method for postoperative pain management. However, most of the patient can not use the device properly. The important cause of inabilities about device usage is insufficient information.In the patient information, visual, oral or written communication methods can be chosen. However, which method is suitable for our patient group is not clear.This study is aimed to show the effect of information method on properly usage of the patient controlled analgesia(PCA) device

Eligibility criteria: Inclusion Criteria:

* informed consent
* Elective hysterectomy

Exclusion Criteria:

* Opioid abuse or Chronic opioid usage
* opioid allergy
* obesity(BMI\>30)
* psychiatric disease
* more than American Anesthesiologist Score 2

Primary outcomes:
measure: Pain Score
timeFrame: At postoperative 24th hours.
Secondary outcomes:
measure: Postoperative analgesic consumption
timeFrame: Up to the postoperative 24th hours.
measure: PCA device usage
timeFrame: During postoperative 24 hours
measure: PCA device demand dose duration
timeFrame: During postoperative 24hours
measure: Patient's satisfaction
timeFrame: At the postoperative 24th hours
measure: The change of the postoperative pain score
timeFrame: Up to the postoperative 24th hours.
Other outcomes:
measure: Length of stay hospital
timeFrame: Up to the postoperative 10 days
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University Hospital
state: Merkez
Study officials:
affiliation: Gaziosmanpasa University
name: Serkan Karaman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01126060: Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain
Official title: Efficacy of Fibrin Sealant to Reduce the Amount of Postoperative Drain in Patients With Harmonic Scalpel-assisted Total Thyroidectomy With Anterior Compartment Neck Dissections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thyroid Carcinoma
Thyroidectomy
Keywords: Neck dissection
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fibrin sealant has been studied to reduce post-thyroidectomy drain and hospital stay as well. However, no strong evidence from well-designed clinical trials is available. Harmonic scalpel is a ultrasonic vibrating scissors which makes it easy to cut and coagulate the tissues, thus reducing op time and postoperative drain, which is important to minimize hospital stay. The investigators hypothesized that fibrin sealant combined with harmonic scalpel-assisted procedure could guarantee no-drain postoperative care in total thyroidectomy with anterior compartment neck dissection.


Eligibility criteria: Inclusion Criteria:

* proven thyroid carcinoma
* Thyroidectomy with anterior compartment neck dissection

Exclusion Criteria:

* No use of harmonic scalpel during surgery
* coagulation abnormality
* refuse to participate

Primary outcomes:
measure: Postoperative Drainage Amount
timeFrame: serial measurement from 1day to 4day after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT02134860: Bed Rest, Alternate Daily Fasting and Incretin Effect
Official title: A Randomized Controlled Study on the Incretin Effect, Cognitive Function and Controlled Fasting During Bed Rest in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Type 2 Diabetes
Critical Illness
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Bed rest produces insulin resistance in healthy volunteers. In this study the investigators aim to investigate the effect of 8 days bed rest on the incretin effect and how alternate daily fasting affects cognitive function and the insulin resistance produced by bed rest.

The subjects will be randomized to either 3 meals a day (isocaloric diet), alternate daily fasting or one meal/day every second day (25% of daily calorie need) and four meals/day every second (175% of daily calorie need).

The investigators hypothesize:

1. Bed rest reduces the incretin effect
2. Alternate daily fasting improves the cognitive function (memory and concentration) compared to isocaloric diet
3. Alternate daily fasting reduces insulin resistance produced by bed rest compared to isocaloric diet

Detailed description: All subjects will undergo 8 days of bedrest. Outcome measures will be performed before, under and immediately after the bed rest period.

The individual study period will be 10 days in total.

Eligibility criteria: Inclusion Criteria:

* BMI\<25kg/m2
* VO2 max normal for age

Exclusion Criteria:

* Tobacco smoking
* Alcohol ingestion \> 14 units per week
* Diabetes in nearby relatives
* Resection of the small intestine
* History of gastric bypass surgery
* Risk of deep venous thrombosis
* Female

Primary outcomes:
measure: Incretin effect
timeFrame: 24 weeks
measure: Cognitive function
timeFrame: 18 months
measure: Insulin resistance
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, 7641
name: Nina Majlund Harder-Lauridsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, 7641
name: Signe Tellerup Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, 7641
name: Rikke Krogh-Madsen, MD. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, 7641
name: Bente Klarlund Pedersen, Professor
role: STUDY_DIRECTOR
References:
citation: Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
Clinical trial NCT03375060: Histology Post-Endoscopic Eradication Therapy (EET)
Official title: Optimizing Patient Outcomes Through Early Detection of Uncontrolled Acid Reflux After Endoscopic Therapy in Barrett's Esophagus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Reflux
Barrett Esophagus
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone EET and 24hr pH impedance testing as part of standard of care at Northwestern Memorial Hospital between 1/1/2009 and 12/31/2014 and who have enrolled in the Prospective Evaluation of Barrett's Esophagus database (NCT02634645).

Brief summary: This study is looking at a cohort of patients who have undergone treatment for Barrett's Esophagus (BE) and who have experienced complete eradication of the disease. The aim of the proposed study is to evaluate the histologic features of the neosquamous epithelium (NSE) following complete eradication of intestinal metaplasia (CE-IM) in patients undergoing routine surveillance biopsies and compare these data to a direct measure of reflux using 24hr pH impedance, to determine the correlation between histology and persistent reflux. These data will allow us to more accurately risk stratify patients for recurrence of BE following EET.


Eligibility criteria: Inclusion Criteria:

* - Patients who have undergone endoscopic eradication therapy and 24hr pH impedance testing as part of standard of care between 2009 and 2014.
* - Individuals who have signed a consent to be part of the Prospective Evaluation of Barrett's Esophagus Study population.

Exclusion Criteria:

* - Individuals who are not yet adults (infants, children and teenagers), pregnant women and prisoners will be excluded from the study.
* - Patient who were previously unable or unwilling to give consent to the Prospective Evaluation of Barrett's Esophagus Study will be excluded.

Primary outcomes:
measure: Composite histologic score of neosquamous epithelium following endoscopic eradication therapy (EET)
timeFrame: 1 year
Secondary outcomes:
measure: 24hr pH-impedance testing: percent acid reflux
timeFrame: 1 year
measure: 24hr pH-impedance testing: baseline impedance
timeFrame: 1 year
measure: 24hr pH-impedance testing: Demeester score
timeFrame: 1 year
measure: Correlation between histologic features and persistent reflux
timeFrame: 1 year
measure: Recurrence rate of intestinal metaplasia (Barrett's esophagus)
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References: