louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01528098: Comparison of Bowel Cleansing Methods for Colonoscopy in Hospitalized Patients
Official title: Efficacy of Bisacodyl Given as Part of a Polyethylene Glycol-based Bowel Preparation Prior to Colonoscopy in Hospitalized Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intestine; Complaints
Keywords: polyethylene glycol
bisacodyl
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
Collaborators: name: Soon Chun Hyang University
name: Kyunghee University
name: Hanyang University
First posted: 2012-02-07
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients for colonoscopy in university hospital.

Brief summary: The purpose of this study is to compare two regimens of polyethylene glycol(PEG) plus bisacodyl versus PEG alone for bowel preparation in hospitalized patients.

Detailed description: Inadequate bowel preparation may lead to a longer colonoscopy, and to an inability to identify lesions. PEG can provide a rapid orthograde peroral approach to colonic lavage without producing significant fluid or electrolyte changes. Thus PEG is now commonly used for bowel preparation. However, large amounts and unsatisfactory taste of PEG solution are generally poorly tolerated, especially in hospitalized patients who had comorbidity and restricted ambulation. Recently, a new PEG-based bowel cleansing agents became available. It combines PEG with a high dose of ascorbic acid or bisacodyl. Although many studies reported the efficacy of these combined solution for colonoscopy, but efficacy in hospitalized patients was under-recognized.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients for colonoscopy

Exclusion Criteria:

* age under 20 years or over 80 years
* major psychiatric illness
* known allergy to PEG
* serious condition- severe cardiac, renal, or metabolic diseases
* partial colon resection
* current acute exacerbation of chronic inflammatory bowel disease
* functional constipation defined by Rome III diagnostic criteria

Primary outcomes:
measure: The efficacy of bowel preparation
timeFrame: one day (after colonoscopy)
Secondary outcomes:
measure: Patient's compliance and acceptability
timeFrame: one day (after injestion of preparation solution)
measure: Patient's compliance and acceptability (2)
timeFrame: one day (after injestion of preparation solution)
measure: Patient's compliance and acceptability (3)
timeFrame: one day (after colonoscopy)
Other outcomes:
Locations:
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Dong Il Park, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00681798: Dose Escalation Study With Zactima and Chemotherapy in Metastatic Pancreas Carcinoma
Official title: Dose Escalation Study of the Combination of ZD6474, Gemcitabine and Capecitabine in Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
pancreatic adenocarcinoma
pancreas cancer
dose escalation study
locally advanced unresectable pancreatic adenocarcinoma
Zactima
Vandetanib
ZD6474
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to define th Maximum Tolerated Dose (MTD) and the recommended dose (RD) of ZD6474 in combination with a fixed standard dose of gemcitabine and capecitabine


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of locally advanced unresectable or metastatic pancreatic adenocarcinoma
* ECOG performance status \<1
* Measurable disease

Exclusion Criteria:

* Severe or uncontrolled systemic disease
* Clinically significant cardiac event such as myocardial infarction
* Any concomitant medication that may cause OTc prolongation, include Torsades de Pointes

Primary outcomes:
measure: Define Maximum Tolerated Dose (MTD)
timeFrame: during whole study
measure: Define Recommended Dose (RD)
timeFrame: during whole study
Secondary outcomes:
measure: Evaluate safety profile
timeFrame: during whole study
measure: Determine antitumour activity as determined by overall response rate (RR), progression free survival (PFS), disease control rate and duration of response
timeFrame: every 2 months
Other outcomes:
Locations:
city: St Gallen
country: Switzerland
facility: Research Site
state: SG
city: Bellinzona
country: Switzerland
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Saletti P, Sessa C, De Dosso S, Cerny T, Renggli V, Koeberle D. Phase I dose-finding study of vandetanib in combination with gemcitabine in locally advanced unresectable or metastatic pancreatic adenocarcinoma. Oncology. 2011;81(1):50-4. doi: 10.1159/000330769. Epub 2011 Sep 15.
Clinical trial NCT03505398: Study of Visual-spatial Attention by Eye Tracking as a Function of Central or Peripheral Visual Impairment
Official title: Study of Visual-spatial Attention by Oculomotor Recording (Eye Tracking) as a Function of Central or Peripheral Visual Impairment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Central or Peripheral Visual Impairment
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this pilot work is to determine the role of central and peripheral visions in explicit attention processes (saccade planning) in the case of visual impairment.


Eligibility criteria: Inclusion Criteria:

* Male or female ≥18 years;
* Patient with a central visual deficit (central scotoma on the visual field: DMLA, cones dystrophy ...) or peripheral (annular scotoma: chronic glaucoma, retinitis pigmentosa ...) or without visual deficit (corrected visual acuity and visual field)
* Patient agreeing to participate in the study and signing informed consent
* Patient affiliated to social security

Exclusion Criteria:

* Pregnant woman
* Patient with known epilepsy
* Major under judicial safeguard, or deprived of liberty
* Major under guardianship or curatorship or admitted to a health or social institution for purposes other than research.

Primary outcomes:
measure: Measurement of visual acuity (central versus peripheral)
timeFrame: Day 0
measure: Microperimetry recording (central versus peripheral)
timeFrame: Day 0
measure: recording of automated visual field (central versus peripheral)
timeFrame: Day 0
measure: recording of eye movements (central versus peripheral)
timeFrame: Day 0
Secondary outcomes:
measure: Measurement of visual acuity (patient versus control)
timeFrame: Day 0
measure: Microperimetry recording (patient versus control)
timeFrame: Day 0
measure: recording of automated visual field (patient versus control)
timeFrame: Day 0
measure: recording of eye movements (patient versus control)
timeFrame: Day 0
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References:
Clinical trial NCT00202098: Effects of Variable Ventilation on Respiratory System of Acute Respiratory Distress Syndrome (ARDS) Patients
Official title: Effects of Variable Ventilation on Respiratory System of ARDS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS
Keywords: ARDS
mechanical ventilation
variable ventilation
chaotic ventilation
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of variable ventilation on respiratory system of patients affected by acute respiratory distress syndrome.

Detailed description: In this interventional study we want to evaluate the effect of Variable ventilation (1) in patients with ARDS. Patients will be mechanically ventilated with Variable Ventilation (3 step with increased level of variability) and "traditional" CMV, for a total of 4 step. Each step lasts in 60 minutes. During this period we will record the gas exchange parameters and the mechanics of the respiratory system.

1. Arold S, Mora R, Lutchen K, et al. Variable ventilation improves lung mechanics and gas exchange in a rodent model of acute lung injury. Am J Resp Crit Care Med 2000; 165: 366-71.

Eligibility criteria: Inclusion Criteria:

* Patients with ARDS criteria

Exclusion Criteria:

* Age less than 18 years
* Severe haemodynamic instability
* Patients with clinical or instrumental evidence of flow-limitation (i.e., PEEPi)

Primary outcomes:
measure: Gas exchange and respiratory mechanics
timeFrame: within the first 60 minutes from the ventilatory change
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Policlinico Hospital
Study officials:
affiliation: Policlinico Hospital Milan
name: Paolo Taccone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03777098: Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis
Official title: Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Group A Streptococcal Infection
Lead sponsor: Olive View-UCLA Education & Research Institute
Sponsor class: OTHER
Collaborators: name: Light AI, Inc.
First posted: 2018-12-17
Enrollment: 426
Sex: ALL
Minimum age (years): 7
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to participating U.S. emergency departments or clinics with complaint of pharyngitis will be screened.

Brief summary: The objective of this pilot study is to acquire images using the Strepic® device, a clinical prototype that has been designed specifically as a viable, low-cost, commercially realizable autofluorescence-based diagnostic test, using (1) fluorescence and (2) white light image data, as well as other clinical data points. By acquiring and analyzing the images of pharyngeal bacterial fluorescence and white light patterns in patients with Group A Streptococcus (GAS)-associated pharyngitis and comparing them with those observed in non-GAS pharyngitis, it is believed an algorithm can be developed such that the device will improve the ability of clinicians to quickly and accurately identify GAS infections.


Eligibility criteria: Inclusion Criteria:

1. All patients aged 7-64 years of age with suspected GAS pharyngitis with modified Centor (McIsaac) score ≥2; and
2. Patient agrees to participate in study and patient or parent/guardian sign consent/assent form.

Exclusion Criteria:

1. Pharyngeal swab performed immediately prior to study team approach;
2. Prior enrollment in this study;
3. Pharyngeal symptoms \>7 days;
4. Peritonsillar abscess;
5. Antibiotic use within one week of index visit;
6. Inability to open mouth to visualize the pharynx; and
7. Inability to understand English or Spanish, as study forms including consent and assent forms will be written in English and Spanish;
8. Woman who is pregnant (self-reported, pregnancy test will not be performed) or nursing;
9. Current prisoner (define as an individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution).

Primary outcomes:
measure: Strepic Device Image
timeFrame: Day 1
measure: Throat culture or PCR result
timeFrame: Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
Study officials:
affiliation: Olive View-UCLA Education & Research Institute
name: Gregory Moran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03220698: Utility of Tracheal Ultrasonography for the Confirmation of the Endotracheal Tube Placement
Official title: Utility of Tracheal Ultrasonography for the Confirmation of Endotracheal Tube Placement During Intubation: A Diagnostic Accuracy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation Complication
Keywords: endotracheal intubation
confirmation
ultrasonography
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for the inclusion were consecutive adults (\>=18 years) intubated in the ED during the shifts of the researchers (TM, OFC). We excluded patients if they have anatomical, traumatic or tumoral defect(s) at the site of sonographic imaging.

Brief summary: The aim of this study is to compare tracheal ultrasound with direct visualization of tracheal rings for the confirmation of endotracheal tube placement in intubated patients. We hypothesize that this method is more reliable, cheap, and readily available for all emergency physicians.

Detailed description: Confirmation of the ETT placement has utmost importance in the management of airway in emergency medicine (EM). Visual examination of the tube (fogging), auscultation, chest x-ray, capnography, capnometry and fiberoptic bronchoscopy are the main tools used for confirmation with increasing diagnostic utilities. Recently, tracheal ultrasonography (US) was introduced as a reliable, cheap and readily available method of confirmation of ETT placement.

Eligibility criteria: Inclusion Criteria:

* adults (\>=18 years)
* intubated in the ED
* during the shifts of the researchers (TM, OFC).

Exclusion Criteria:

* anatomical, traumatic or tumoral defect(s) at the site of sonographic imaging

Primary outcomes:
measure: Presence of endotracheal tube in trachea
timeFrame: Immediately after the intubation process
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Marmara University
name: Haldun Akoglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06180798: Cold Snare Endoscopic Mucosal Resection (C-EMR) Versus Hot Snare Endoscopic Mucosal Resection (H-EMR) for Large Colorectal Polyps (10-20 mm)
Official title: Cold Snare Endoscopic Mucosal Resection (C-EMR) Versus Hot Snare Endoscopic Mucosal Resection (H-EMR) for Large Colorectal Polyps (10-20 mm) - A Randomised Control Trail.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polyps of Colon
Polyps
Polyp Intestine
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single center randomized controlled study with two parallel groups with a 1:1 allocation ratio.
Primary purpose: TREATMENT

Brief summary: OBJECTIVES The aim of the study is to compare the efficacy of cold snare EMR versus hot snare EMR for non-pedunculated polyps 10-20mm in size with respect to complete resection rates and adverse events.

DESIGN : A Randomised interventional study. Sample size: 330

Detailed description: * This procedure will be performed by Endoscopists having above 3 years of experience you will be in the left lateral position under propofol sedation.
* In Both groups (a mixture of saline and blue dye will be injected beneath the surface layer,and then a snare(is a ring shaped device used to cut polyp after surrounding it- like a rubber band ) will be used to remove tissue without using heat in Cold Endoscopic mucosal resection group and using electrosurgical unit (to control bleeding and to rapidly dissect soft tissue in surgery) by EndoCut Q mode (ensures safe and effective removal of large lesions in particular large polyps) in Hot Endoscopic mucosal resection group.
* After polypectomy (the surgical removal of a polyp) the area is inspected for residual polyp (presence of any type of tissue) using NBI (Narrow band imaging) and if present, will be CUT OFF.

  * A Standard snare ( snare is a ring shaped device used to cut polyp after surrounding it- like a rubber band) is used to cut the polyps

Eligibility criteria: Inclusion Criteria:

* Adult above 18 years
* polyp size greater than 5-10mm.

Exclusion Criteria:

* Inflammatory bowel disease
* Familial Polyposis Syndromes
* Patient who is unable to understand study protocol or not consenting
* Severe coagulopathy (INR Greater than 1.5 platelets)
* Receiving antiplatelets withing 5 days of procedure
* If antiplatelets stopped for 5 days-they were restarted on next day after procedure.

Primary outcomes:
measure: Assess the complete resection rate
timeFrame: 1 YEAR
Secondary outcomes:
measure: Secondary outcomes include procedure time, cost and adverse events.
timeFrame: 1 YEAR
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Krithi Krishna Koduri
state: Telanagana
Study officials:
affiliation: Asian Institute of Gastroenterology
name: Krithi Krishna Koduri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02168998: Cortisol Measurement During Intravenous Access With a Medical Clown
Official title: Level of Cortisol in Stress Response During Intravenous Access in the Pediatric Emergency Department With a Medical Clown: a Randomized Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Physiological
Keywords: Medical clown
Pediatric emergency medicine
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-06-20
Enrollment: 55
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the presence of a medical clown in a pediatric emergency department procedure room would reduce children's anxiety. The investigators hypothesize that this positive influence will be expressed as lower levels of the stress hormone (Cortisol) in the blood.


Eligibility criteria: Inclusion Criteria:

* Patients needing venous blood sampling or insertion of an intravenous canula
* Normal development according to parents

Exclusion Criteria:

* Critically ill children (e.g. shock, respiratory distress or failure)
* Children whose blood work or intravenous canula must be obtained rapidly for therapeutic reasons (e.g. antibiotic administration in a patient with severe bacterial infections)
* Known adrenal or pituitary disease
* Children who have received glucocorticoids during the preceeding six weeks

Primary outcomes:
measure: Blood Cortisol level
timeFrame: During intravenous cannulation or blood sampling
Secondary outcomes:
measure: Vital signs (heart rate, respiratory rate, blood pressure)
timeFrame: During intravenous cannulation or blood sampling
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Ayelet Rimon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel-Aviv Sourasky Medical Center
name: Miguel Glatstein, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02379598: Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy
Official title: Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cow's Milk Allergy
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with a sure diagnosis of cow's milk allergy

Brief summary: Cow's milk allergy is an immunologically mediated adverse reaction to milk proteins. In industrialized countries there is an incidence of 2-3% in children younger than 2 years. Cow's milk allergy may present with different clinical pictures and symptoms often nonspecific. Among the most common are certainly food refusal and failure to thrive until frameworks frank malnutrition. It was also noted that the cow's milk allergy can have a negative impact on the quality of life of the patient and his family.

The treatment of this condition provides the setting of a diet that is free of the allergen to the base of the adverse reaction.

There are some types of formulas for the treatment of this condition. The formulas based on amino acids are currently used in all cases non-responsive to treatment with the above formulas or in all those characterized by severe allergic reactions. Being made from amino acids such formulas are by definition non-allergenic. They have also proven to ensure a rapid resolution of symptoms favoring a resumption of growth, nutritional status, as well as lead to a rapid improvement in the quality of life of the patient and his family. However, the studies currently available to us concerning the effects of nutritional formulas based on amino acids affect short observation periods (usually less than 6 months) and were directed to a comparison only with hydrolysates of whey protein or casein and not with healthy subjects. To date thus lack consistent data on the nutritional effects in the medium to long term.


Eligibility criteria: Inclusion Criteria:

* subjects with diagnosis of cow's milk allergy

Exclusion Criteria:

* age \<5 months
* age \>12 months
* other concomitant chronic diseases
* malformations
* other food allergies

Primary outcomes:
measure: change of z-score weight at 12 months
timeFrame: after 12 months of intervention
Secondary outcomes:
measure: change of body mass index at 12 months
timeFrame: after 12 months of intervention
Other outcomes:
Locations:
city: Naples
country: Italy
facility: university of naples federico II
Study officials:
References:
citation: Canani RB, Nocerino R, Frediani T, Lucarelli S, Di Scala C, Varin E, Leone L, Muraro A, Agostoni C. Amino Acid-based Formula in Cow's Milk Allergy: Long-term Effects on Body Growth and Protein Metabolism. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):632-638. doi: 10.1097/MPG.0000000000001337.