louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00576043: Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy
Official title: Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: training
Patient satisfaction
endoscopy
simulator
Safety
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-12-18
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Trainees (Residents in internal medicine), naive to real patient endoscopy, will be randomized to receive either 3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator GI-Mentor or no training before starting on-patient endoscopy in the University of Vienna Medical School Endoscopy Unit. Patients satisfaction and pain, technical accuracy and number of found/missed pathologies as well as average time for successful endoscopy will be recorded. After one month or 50 supervised, self performed endoscopies, trainees will be evaluated again with the above mentioned criteria during ten consecutive investigations.


Eligibility criteria: Inclusion Criteria:

* Trainees: naive to real patient endoscopy before training phase

Exclusion Criteria:

* Medical doctors with experience in gastrointestinal endoscopy
* Patients sedated for upper GI endoscopy
* Patients unwilling or unable to sign informed consent

Primary outcomes:
measure: Patient satisfaction measured on a visual analogue scale (VAS)
timeFrame: once immediately after patient endoscopy
Secondary outcomes:
measure: pain during endoscopy, measured with patient documentation on a visual analogue scale (VAS)
timeFrame: once immediately after patient endoscopy
measure: technical accuracy (oral introduction of the scope into the esophagus, ability of passing the endoscope through the pylorus, inversion of the scope in the gastric fundus)
timeFrame: during endoscopy
measure: number of found/missed pathologies
timeFrame: during endoscopy
measure: average time for successful endoscopy
timeFrame: during endoscopy
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Internal Medicine III, Div. of Gastroenterology and Hepatology, Endoscopy Unit, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Arnulf Ferlitsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferlitsch A, Glauninger P, Gupper A, Schillinger M, Haefner M, Gangl A, Schoefl R. Evaluation of a virtual endoscopy simulator for training in gastrointestinal endoscopy. Endoscopy. 2002 Sep;34(9):698-702. doi: 10.1055/s-2002-33456.
Clinical trial NCT00898443: Continuous Labor Epidural Catheter for Tubal Ligation Study
Official title: Success Rate, Efficiency, and Predictors of Reactivation of a Continuous Labor Epidural Catheter for Postpartum Tubal Ligation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tubal Ligation
Bilateral Tubal Ligation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2009-05-12
Enrollment: 18
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is to study the success rate of using the epidural catheter that was placed during the labor for the surgical anesthesia to perform a postpartum tubal ligation.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) 1-3 postpartum women desiring Postpartum Bilateral Tubal Ligation (PPBTL) for infertility
* Functional epidural catheter placed for labor and delivery analgesia
* The epidural is still taped within 1cm of the original depth when it was functional for labor analgesia
* 1-45 years of age

Exclusion Criteria:

* ASA 4 status
* History of dural puncture ("wet tap") during initial epidural catheter insertion
* History of marginal or inadequate epidural analgesia for labor
* Cesarean section for delivery
* Examination demonstrates that the indwelling catheter has migrated more than 1 cm from the original depth when secured
* The end of indwelling epidural catheter appears to have not been capped appropriately or the cap was not maintained intact
* Prolonged sensory or motor block, bladder or anal sphincter dysfunction, nerve damage, inability to ambulate, post-dural puncture headache (PDHD), or seizures, during or after delivery and following cessation of the epidural catheter dosing
* Pseudocholinesterase deficiency
* Allergy to Nesacaine® (chloroprocaine) or lidocaine
* General anesthesia provided for delivery
* History of substance abuse disorder
* History of major psychiatric disorder
* Non-English reading/speaking participants

Primary outcomes:
measure: Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation
timeFrame: at the time of surgery
Secondary outcomes:
measure: Impact of Anesthesia Type on OR (Operating Room) Efficiency
timeFrame: minutes until surgery start
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: UAB Department of Anesthesiology
name: Marsha L. Wakefield, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06897943: Epidemiology of Gonococcal Arthritis (EpGAr)
Official title: Epidemiology of Gonococcal Arthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gonococcal (GC) Infection
Arthritis, Infectious
Keywords: gonococcal arthritis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a Neisseria gonorrhoeae-positive joint sample (from an enrichment vial or a native sample) between 06/01/2014 and 06/30/2024.

Brief summary: The aim of this retrospective observational study was to describe the epidemiology of Neisseria gonorrhoeae septic arthritis over the last 10 years at Brest and Rennes university hospitals. The main question is whether there are any risk factors based on the epidemiological and clinical data on these cases. The second objective is to characterize the gonococcal strains isolated in order to determine whether there is a common clone, a virulence factor or specific resistance genes.


Eligibility criteria: Inclusion Criteria:

* Patients with a Neisseria gonorrhoeae-positive joint sample (from an enrichment vial or a native sample) between 2014 and 2024.

Exclusion Criteria:

* Patients with Neisseria gonorrhoeae-negative joint sample (from enrichment vial or native sample).
* Patients who have expressed opposition to inclusion in the study.
* Patients under legal protection (guardianship, curatorship, etc.).

Primary outcomes:
measure: Age
timeFrame: 10 years
measure: Date of sampling
timeFrame: 10 years
measure: Type of sample
timeFrame: 10 years
measure: Rate of white blood cells
timeFrame: 10 years
measure: Sexually transmitted infection
timeFrame: 10 years
measure: Men who have sex with men
timeFrame: 10 years
measure: HIV pre-exposure prophylaxis (PreP)
timeFrame: 10 years
measure: Comorbidities
timeFrame: 10 years
measure: Imaging
timeFrame: 10 years
measure: Blood cultures (peripheral blood)
timeFrame: 10 years
measure: Time to diagnosis
timeFrame: 10 years
measure: Treatments implemented
timeFrame: 10 years
measure: Antibiotic sensitivity profile
timeFrame: 10 years
measure: Surgery
timeFrame: 10 years
measure: Evolution
timeFrame: 10 years
measure: Rate of neutrophils
timeFrame: 10 years
measure: Rate of CRP (C-reactive protein)
timeFrame: 10 years
Secondary outcomes:
measure: Molecular typing: clone
timeFrame: 10 years
measure: Molecular typing: virulence factors
timeFrame: 10 years
measure: Molecular typing: resistance genes
timeFrame: 10 years
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
state: Brittany
city: Brest
country: France
facility: CHU de BREST
Study officials:
affiliation: CHU de Brest
name: Geneviève HERY-ARNAUD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01577043: Efficacy of Racecadotril in Acute Watery Diarrhea in Children
Official title: Efficacy of Racecadotril in the Management of Acute Watery Diarrhea in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Diarrhea
Acute Gastroenteritis
Keywords: acute diarrhea
Racecadotril
children
Lead sponsor: Centro Pediatrico Albina de Patino
Sponsor class: OTHER
First posted: 2012-04-13
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
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 the effect of racecadotril in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.

Detailed description: Background: Treatment of acute diarrhea is based on the following various oral rehydration management guidelines. Lately other drugs currently under investigation as antisecretory drugs to shorten the diarrheal episode and can be used safely in children.

Objectives: To evaluate the effect of racecadotril in the treatment of children under 5 years of age with acute diarrhea.

Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients: One group will receive racecadotril plus oral rehydration and the other one will receive placebo plus oral rehydration; the parameters of evaluation are going to be the duration of diarrheal episode, number of stools by day, weight of stool, nutritional state.

Eligibility criteria: Inclusion Criteria:

* Acute watery diarrhea

Exclusion Criteria:

* Severe malnourishment
* Severe dehydration
* Systemic infections
* Coinfections

Primary outcomes:
measure: Duration of diarrheal episode
timeFrame: five days
Secondary outcomes:
measure: Duration of hospitalization
timeFrame: five days
measure: Weight of stool
timeFrame: five days
measure: Frequency of stool per day
timeFrame: five days
Other outcomes:
Locations:
city: Cochabamba
country: Bolivia
facility: Centro Pediatrico Albina de Patino
Study officials:
affiliation: Centro Pediatrico Albina de Ptino
name: Giuseppe Grandy, MD MSc
role: STUDY_DIRECTOR
affiliation: Centro Pediatrico Albina de Patino
name: Richard Soria, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Pediatrico Albina de Patino
name: Jackeline Torrez, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01232543: Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis
Official title: An Open-Label Evaluation of the Adrenal Suppression Potential of Product 0405 in the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Lead sponsor: Fougera Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-02
Enrollment: 114
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the trial is to assess Adrenal Suppression potential when pediatric subjects are administered Product 0405 for the treatment of Atopic Dermatitis

Detailed description: Treatment medication will be administered topically, twice a day for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Atopic Dermatitis
* Good health with the exception of Atopic Dermatitis
* Percent body surface area minimum requirements

Exclusion Criteria:

* Subjects who are pregnant, nursing, or planning a pregnancy

Primary outcomes:
measure: Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression.
timeFrame: 4 weeks
Secondary outcomes:
measure: Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Melville
country: United States
facility: Fougera Pharmaceuticals Inc.
state: New York
Study officials:
affiliation: Fougera Pharmaceuticals Inc.
name: Kathleen Ocasio, CCRA
role: STUDY_DIRECTOR
References:
Clinical trial NCT04534738: The Effect of a Mediterranean Diet Intervention on Cancer-related Fatigue and Mitochondrial Function During Chemotherapy
Official title: Diet And Nutrition In CAncer (The DANICA Study): The Effect of a Mediterranean Diet Intervention on Cancer-related Fatigue and Mitochondrial Function During Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cancer
Keywords: nutrition
diet
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will assess the feasibility of delivering an 8-week Mediterranean Diet intervention as well as the intervention's preliminary efficacy on cancer-related fatigue among patients undergoing chemotherapy, compared to usual care. In the first 4 weeks of the intervention, we will provide the participants with food and educate them on the principles and components of the Mediterranean Diet, while in the second 4 weeks participants will prepare their own food. In addition, we will evaluate changes in metabolism and mitochondrial function during 4 weeks of chemotherapy and determine how adherence to a Mediterranean diet modulates these changes during these 4 weeks.

The hypothesis is that the intervention will promote adherence to the Mediterranean Diet. The second hypothesis is that adherence will be associated with alleviation of fatigue and improvements in metabolic and mitochondrial function.


Eligibility criteria: Inclusion Criteria (Participants must...):

* Have a diagnosis of cancer,
* Be scheduled to receive chemotherapy and have at least 6 weeks remaining,
* Be able to speak English,
* Be willing to adhere to study procedures, and
* Be able to provide written informed consent.

Exclusion Criteria (Participants must not...):

* Be on enteral or parenteral nutrition,
* Be pregnant,
* Have distant metastases,
* Have a brain tumor,
* Have any plan to get radiation to the head,
* Have specific dietary needs that a Mediterranean diet cannot meet (e.g., allergies to nuts, gluten intolerance), or already be following the Mediterranean diet (i.e., have a score ≥10 on a modified 14-item Mediterranean Diet questionnaire).

Primary outcomes:
measure: The Number of Patients Who Enrolled Completed the Study.
timeFrame: 8 weeks
measure: Scores From the 14-item Mediterranean Diet Questionnaire
timeFrame: 8 weeks
Secondary outcomes:
measure: The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire
timeFrame: 8 weeks
measure: The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) Questionnaire, Fatigue Subscale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Pluta Cancer Center
state: New York
city: Rochester
country: United States
facility: Wilmot Cancer Institute
state: New York
Study officials:
affiliation: University of Rochester
name: Amber S. Kleckner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04447638: Percutaneous Tracheostomy With COVID-19
Official title: Percutaneous Tracheostomy With Aerosol Box in COVID-19 Positive Patients in Intensive Care Unit: a Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheostomy
Keywords: Reanimation
Lead sponsor: Çanakkale Onsekiz Mart University
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Percutaneous tracheostomy performed with aerosol box in COVID-19 patients

Brief summary: Coronavirus disease 2019 (COVID-19) has brought about a requirement of intensive care and mechanical ventilation for a significant portion of patients. Percutaneous tracheostomy is performed in order to reduce the complications that may develop due to prolonged endotracheal intubation.

Detailed description: Different methods are needed for situations in which the potential for producing aerosols is high, such as intubation and tracheostomy. One of these methods is the aerosol box.To share our experiences of percutaneous tracheostomy performed with aerosol box in COVID-19 patients. Patients who underwent percutaneous tracheostomy between March 2020 and June 2020 in the pandemic intensive care unit were evaluated retrospectively.The study is designed as a clinical trial study. This study was performed in faculty of medicine hospital's intensive care unit which is located in Canakkale province Turkey.

Eligibility criteria: Inclusion Criteria:

* who underwent percutaneous tracheostomy with COVID-19(+)

Exclusion Criteria:

* Patients who do not give informed consent or do not want to participate in the study
* Coagulopathy, thrombocytopenia

Primary outcomes:
measure: Complications observed in the cases in which we applied percutaneous tracheostomy with aerosol box
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Canakkale
country: Turkey
facility: Canakkale Onsekiz Mart University
Study officials:
References:
Clinical trial NCT01816438: A French Non Interventional Multicentric Cohort Study in Patients With Colorectal Dysplasia
Official title: A French Non Interventional Multicentric Cohort Study in Patients With Colorectal Dysplasia in Intestinal Inflammatory Diseases
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hyperplasia
Dysplasia
Keywords: abnormal histological colorectal lesions
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In France more than 40000 persons are concerned with a high risk of cancer because of ulcerative colitis for example

Brief summary: The main purpose is to describe clinical practices nowadays prospectively about patients with a dysplasia diagnosis or another histological lesions.

It will be identified colic situation during the initial colonoscopy after dysplasia diagnosis or atypical lesion.

Also the frequency and the type of monitoring conducted about these patients(surgical and endoscopic treatments).

The main criterion evaluation will be the surgical and endoscopic rates during the time.

The treatments offered such as surgical, endoscopic ones or none of them will be followed.

Finally, the outcome of these patients: stability, lesion disappearance, surgery or development of cancer with frequencies for each of them and relationships with histological abnormal colorectal lesion will be measured.

Detailed description: A replay centralized pathological lesion slides corresponding to the different lesion will be done

Eligibility criteria: Inclusion Criteria:

* intestinal chronic inflammatory disease with at least one lesion such as hyperplasia or no dysplastic scalloped lesion, dysplastic scalloped lesion or low grade dysplasia or high grade dysplasia
* compliant patient
* endoscopic follow possible
* no settler cancer
* no serious pathology such as cancer

Exclusion Criteria:

* settler cancer
* serious pathology such as cancer
* no compliant patient
* endoscopic follow not possible

Primary outcomes:
measure: endoscopies results
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Edouard Herriot Hospital
state: Rhône Alpes
Study officials:
affiliation: no affiliated
name: Saurin Jean Christophe, MSD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02474238: Comparing Nd:YAG Laser and Sequential Double Frequency YAG-Nd:YAG Laser Iridotomy
Official title: Randomized Clinical Trial Comparing Neodynium:Ytrium-aluminium-garnet (Nd:YAG) Laser and Sequential Double Frequency YAG-Nd:YAG Laser Iridotomy in Patients With Dark Iris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angle Closure Glaucoma
Keywords: Iridotomy
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2015-06-17
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: No single type of laser or set of laser parameters is appropriate for all type of irides. Pure Nd:YAG laser iridotomy is very effective in the light color irides. It was considered as the gold standard for iridotomy. It, however, is less effective and causes some complication such as iris hemorrhage especially in patients with dark iris.

Detailed description: By using the double frequency YAG to make the initial bore and the Nd:YAG laser to complete the perforation, the technique should be able to effectively combine most of the advantages of both lasers whilst avoiding their disadvantages. It is possibly the ideal iridotomy technique to use in the Asian irides. The investigators aim to study the energy use for laser iridotomy comparing between the two techniques as well as objectively measure the variables associated with complications.

Eligibility criteria: Inclusion Criteria:

* Patient in need to have a laser iridotomy

  * primary angle closure glaucoma or
  * primary angle closure or
  * primary angle closure suspect (needed repeated pupil dilation) or
  * fellow eyes of acute angle closure crisis, and
* Age of at least 18 years, and
* Dark iris patients (only black and dark brown color)

Exclusion Criteria:

* Eye with acute angle closure crisis
* Active conjunctiva or corneal infection or inflammation
* Active anterior uveitis
* History of any prior laser treatment
* History intraocular surgery
* Eye with corneal scar
* Corneal haziness obscure iridotomy site
* Endothelial cell count less than 1000 cells/mm2 (pre-laser)
* Iris color other than black or dark brown
* Inability to sit at the slit lamp to have laser done

Primary outcomes:
measure: Laser energy
timeFrame: 1-hour
Secondary outcomes:
measure: Bleeding
timeFrame: 1-hour
measure: Corneal endothelial cell count
timeFrame: 12-month
measure: Central corneal thickness
timeFrame: 12-month
measure: Patency of iridotomy
timeFrame: 12-month
measure: Intraocular pressure spike
timeFrame: 1-hour
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Weerawat Kiddee
state: Songkhla
Study officials:
affiliation: Prince of Songkla University
name: Asst.Prof.Weerawat Kiddee, MD
role: PRINCIPAL_INVESTIGATOR
References: