louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02836938: Breath Volatile Organic Compounds Patterns of Lung Transplant Patients With Chronic Lung Allograft Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lung Allograft Dysfunction (CLAD)
Lead sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine
Sponsor class: OTHER
Collaborators: name: Hannover Medical School
First posted: 2016-07-19
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group of transplant patients with and without signs of BOS

Brief summary: It's the aim of this study to clarify, whether the non-invasive assessment of breath can serve as a novel clinical tool to assist in the diagnosis of CLAD. If different stages of BOS can be discriminated by the level of certain VOCs than there would also be a potential to actually predict the development at an early stage and would enable an earlier intervention.


Eligibility criteria: Inclusion Criteria:

* Outpatient bilateral lung transplant recipients including combined transplants

Exclusion Criteria:

* Active Smoking Oxygen therapy Infection with multi or pan-resistant bacteria

Primary outcomes:
measure: Concentration of exhaled breath volatile organic compounds
timeFrame: one sample will be collected between 6 month and 20 years after lung transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
References:
Clinical trial NCT04214938: Hypertonic Saline Enhances The Field of View of Clinicians and Ease of Procedures
Official title: Hypertonic Saline Enhances The Field of View of Clinicians and Ease of Procedures: A Double Blind, Randomized, Controlled Trial Comparing the Efficacy of Intranasal Hypertonic Saline, Xylometazoline, Lidocaine, and Isotonic Saline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nasopharyngeal Diseases
Keywords: hypertonic saline solutions
lidocaine
oxymetazoline
isotonic saline
discomfort
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Double Blind, Randomized, Controlled Trial
Primary purpose: OTHER

Brief summary: Transnasal Flexible Pharyngolaryngoscopy (NPL) is one of the most common and fundamental evaluation procedures in otolaryngologist's practice, performed in both outpatient and ward settings.In the studies the desired properties for an effective topical agent to be used in patients undergoing NPL. To date, only a local anesthetic and/or decongestant substance is applied to the nostrils to relieve pain. However, to date, no studies have been performed in which intranasal hypertonic saline was used prior to nasal endoscopy.

Detailed description: NPL is a technique that has been used for more than 100 years and increases brightness, magnification and the ability to take still and video images (3). NPL is a simple, safe, cost-effective, and generally well-tolerated procedure. However, a portion of patients may refuse to allow the procedure to be repeated as they find it uncomfortable, intolerable, or painful.To date, only a local anesthetic and/or decongestant substance is applied to the nostrils to relieve pain and increase the field of view and to reduce the duration of examination and unpleasant sensations for the patient on NPL procedures.This randomised control trial was undertaken to compare the application of nasal hypertonic sea water (3.5%) with nasal lidocaine 10%, topical nasal decongestant xylometazoline 0.1% (OtrivineTM) and nasal isotonic serum physiologic as placebo group in relation to how they effectively improve the adequacy of the examination and if they reduce pain and discomfort associated with endoscopic nasal examination.

Eligibility criteria: Inclusion Criteria:

* Subjects who undergone diagnostic nasal endoscopy between 2015- 2017

Exclusion Criteria:

* Had experienced nasal endoscopy before
* Pregnant
* Allergic to either xylometazoline or lidocaine
* Asthma
* Cardiovascular disease
* Rhinitis
* Severe septal deviation

Primary outcomes:
measure: Quality of view, ease of procedure
timeFrame: 2 years
Secondary outcomes:
measure: Post-op pain
timeFrame: 2 years
measure: Post-op discomfort
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Selcuk University
name: Ozkan Onal, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02661438: Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo
Official title: Multicenter Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation in Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB) or Chronic Obstructive Pulmonary Disease (COPD) Using Matching Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Pulmonary Disease, Chronic Obstructive
Keywords: Usability Test
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2016-01-22
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The rationale of this study is to conduct a summative (i.e., validation) usability test of Ciprofloxacin Dry Powder for Inhalation (DPI) and the associated Instructions for Use.


Eligibility criteria: Inclusion Criteria

* Subjects (male and female) with non-cystic fibrosis bronchiectasis (NCFB) or chronic obstructive pulmonary disease (COPD)
* Subjects must be aged ≥40
* Subject must be able to independently manage and administer their NCFB/COPD medications

Exclusion Criteria:

* Subjects with recent exacerbation
* Subjects with recent significant hemoptysis in the four weeks before screening (and/or during the screening period)
* Subjects allergic to quinine
* Known chronic bronchial asthma

Primary outcomes:
measure: The user performed the inhalation task based on the given instructions properly (Yes/No).
timeFrame: 1 Day
measure: The user performed the inhalation task safely (Yes/No).
timeFrame: 1 Day
measure: DPI (Dry powder for inhalation) device malfunction (Yes/No).
timeFrame: 1 Day
measure: Subject's subjective feedback (paraphrased) on use-safety and usability
timeFrame: 1 Day
Secondary outcomes:
measure: Inhalation time
timeFrame: 1 Day
measure: User friendliness
timeFrame: 1 Day
Other outcomes:
Locations:
city: Vero Beach
country: United States
state: Florida
city: Jamaica
country: United States
state: New York
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06596538: Video-Interpreting in an Emergency Trauma Room Setting - a Feasibility Trial
Official title: Video-Interpreting in an Emergency Trauma Room Setting - a Feasibility Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Communication Barriers
Keywords: Communication barriers
Language barriers
Video-Interpreting
Emergency Medicine
Emergency physician
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 50
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: In total 50 adult patients with language barriers, who are treated in the emergency trauma room by doctors of the Department of Anaesthesia, Intensive Care Medicine and Pain Medicine will be included in this study. Inclusion and exclusion criteria as noted above will be followed.

Brief summary: Background: Global migration increases the likelihood of language barriers. In medical situations language barriers have a negative effect on quality of treatment and thus endanger patient safety.

In-hospital settings feasibility of video-translation has been demonstrated, yet there is lack of evidence in emergency trauma rooms. There, the physicians have to deal with time-critical decisions. Aims: This feasibility trial aims to investigate technical feasibility, usability as well as the impact on decision-making (e.g. alteration of treatment strategies). Methods: In this study 50 responsive patients with language barriers will be included. The anesthesiologic emergency physician will start video-translation via a tablet. Feasibility, quality of communication, usability as well as changes in diagnosis and treatment will be gathered and analyzed.


Eligibility criteria: Inclusion Criteria:

* adult patients, at least 18 years old
* awake, responsive patients
* language barrier (Albanian, Dari, Romanian, Turkish, Modern Standard Arabic, Arabic, Farsi, Russian, Hungarian, Bosnian-Croatian-Serbian, Kurdish (Kurmanci), Slovakian, Bulgarian, Polish, and Czech)

Exclusion Criteria:

* unconscious patients
* cardiac arrest patients
* delay of treatment due to e-translation
* refusal of video-translation by the patient

Primary outcomes:
measure: Technical Feasibility
timeFrame: Directly after use of video-interpreting
measure: Usability of video-interpreting
timeFrame: Directly after use of video-interpreting
measure: Impact on emergency physician's decisions
timeFrame: Directly after use of video-interpreting
Secondary outcomes:
Other outcomes:
measure: Demographic parameters
timeFrame: Directly after use of video-interpreting
Locations:
city: Vienna
country: Austria
facility: MUVienna
Study officials:
References:
Clinical trial NCT00000238: Temporal Discounting Delayed Outcomes on Opioid-Dependent Outpatients - 20
Official title: Temporal Discounting Delayed Outcomes on Opioid-Dependent Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Vermont
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the degree in which opioid-dependent outpatients discount the value of an additional maintenance dose of buprenorphine under differing states of opioid deprivation.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Money choice
measure: Heroin craving
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Treatment Research Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Warren Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006138: Diagnostic Pilot Study of Dual Energy Absorptiometry in the Detection of Osteopenia or Osteoporosis in Patients With Thalassemia Major
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Thalassemia Major
Osteopenia
Keywords: disease-related problem/condition
genetic diseases and dysmorphic syndromes
hematologic disorders
osteoporosis
rare disease
thalassemia major
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2000-08-04
Enrollment: 35
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES:

I. Determine the frequency and severity of osteopenia and osteoporosis in patients with thalassemia major who undergo dual energy x-ray absorptiometry, and correlate these findings with other relevant endocrinologic measurements.

Detailed description: PROTOCOL OUTLINE:

Patients undergo dual energy x-ray absorptiometry for bone density measurements, height (sitting and standing) and weight measurements, comprehensive endocrinologic examination, and assessment of the severity of iron overload at baseline, and then at years 1 and 2.

Eligibility criteria: * Diagnosis of thalassemia major with iron overload
* Not pregnant
* Negative pregnancy test

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Alan Richard Cohen
role: STUDY_CHAIR
References:
Clinical trial NCT05709743: Task Switching Between Target Templates During Visual Search in Healthy Adults
Official title: Task Switching Between Positive and Negative Target Templates During Visual Search in Healthy Adults
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy
Keywords: attention
visual search
Lead sponsor: Lehigh University
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants receive each level of visual information (target or distractor)
Primary purpose: BASIC_SCIENCE

Brief summary: In this line of research, the researchers having participants engage in task switching between tasks which require a positive (target) template, negative (distractor) template, or neutral (non-informative) template to the cognitive control factors associated with each template type during visual search. This is a basic science study.

Detailed description: The researchers will have participants engage in task switching between tasks which require a positive (target) template, negative (distractor) template, or neutral (non-informative) template to the cognitive control factors associated with each template type during visual search. Looking for impacts of task switching helps to identify the components of the cognitive control system that overlap between different types of attentional templates. This is a basic science study.

Eligibility criteria: Inclusion Criteria:

* normal or corrected to normal visual acuity, normal color vision

Exclusion Criteria:

-

Primary outcomes:
measure: Button Press Reaction Time
timeFrame: One day (during testing)
measure: Button Press Accuracy
timeFrame: One day (during testing)
measure: Eye Movements to Objects on Computer Screen
timeFrame: One day (during testing)
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: Lehigh University
state: Pennsylvania
Study officials:
affiliation: Lehigh University
name: Nancy Carlisle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03259243: Comparison of Efficacy of Bupivacaine for Relief Postoperative Pain in Women Undergoing Laparoscopic Gynecologic Surgery
Official title: Port Site Infiltration With Bupivacaine for Reduction of Postoperative Pain in Woman Undergoing Gynecologic Laparoscopy: A Randomized, Factorial, Double-Blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain Score
Keywords: Bupivacaine, Port site infiltration ,Postoperative pain ,Gynecologic laparoscopy
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2017-08-23
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To comparison of efficacy of Bupivacaine for relief postoperative pain in women undergoing laparoscopic gynecologic surgery

Detailed description: Gynecologic laparoscopic procedures have become more common nowadays because of their benefits in less tissue trauma, less perioperative morbidity and shorter hospital stays compared with laparotomy. But postoperative pain still be the most concerning problems including discomfort at incision sites, Pain due to pneumoperitoneum stretching the intraabdominal cavity and dissection of the abdominal and pelvic viscera.

Visceral pain is at maximal intensity during the first postoperative hours and is exacerbated by coughing, respiratory movements, and mobilization. Because the pain comprises of several factors, multimodal analgesic techniques are needed for effective postoperative analgesia and brought to this study to compare efficacy of Bupivacaine for pain relief postoperatively in women undergoing gynecologic laparoscopic surgery divided into 4 groups including preincision and preclosure Bupivacaine injection collated with placebo group. The result is measurement in postoperative pain score and amount of drug that using to reduce pain

Eligibility criteria: Inclusion Criteria:

* Patient who undergoing gynecologic laparoscopic surgery
* Patient who agrees to participate in this study
* Patient able to speak and understand Thai
* Patient able to complete the questionnaire

Exclusion Criteria:

* Patient with history of allergy in any kind anesthetic drug
* Patient who pregnant
* Patient who sign for single port gynecologic laparoscopic surgery or NOTE surgery
* Patient whom the surgery is withhold or canceled
* Patient whom the surgery is converted to laparotomy

Primary outcomes:
measure: Postoperative pain after surgery
timeFrame: 24-48 hours after surgery
Secondary outcomes:
measure: Among of pethidine use
timeFrame: within 48 hours
measure: Duration of hospital stay
timeFrame: within 7 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Waetasleem Chema
Study officials:
References:
Clinical trial NCT03385343: Staging of Superficial EAC Using VLE
Official title: Staging of Superficial Esophageal Adenocarcinoma (EAC) Using Volumetric Laser Endomicroscopy (VLE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to see if the NvisionVLE Imaging System can accurately determine the diagnostic performance of staging of T1 esophageal adenocarcinoma.

Detailed description: Volumetric laser endomicroscopy (VLE) is an imaging platform that uses infrared light to generate cross-sectional views of the human esophagus with microscopic resolution. VLE has been used to detect dysplasia associated with Barrett's esophagus (BE) but its use in cancer staging has not been previously explored. The investigators propose that VLE can accurately and comprehensively stage T1 EAC.

VLE scans will be analyzed using an automated computer algorithm to measure degree of signal attenuation over areas demarcated for endoscopic mucosal resection (EMR). The signal attenuation cut-off established will be used to classify cancers as superficial versus deep. EMR specimens will be reviewed histopathologically for grade of tumor differentiation, depth of invasion, and presence or absence of lymphovascular invasion. Depth of tumor invasion will be measured and used to classify cancers as superficial versus deep.

Eligibility criteria: Inclusion Criteria:

* Patient over the age of 18
* Patient undergoing an upper endoscopy with prior-biopsy confirmed Barrett's Esophagus.
* Ability to provide written, informed consent
* No significant esophagitis (LA grade \<B, C, and D)

Exclusion Criteria:

* Patients who have achieved complete remission of intestinal metaplasia (CR-IM)
* Patients without visible Barrett's Esophagus at the time of study esophagogastroduodenoscopy (EGD)
* Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use.
* Prior esophageal or gastric surgical resection
* Significant esophageal stricture requiring dilatation
* Patients who require anticoagulation for who biopsy would be contraindicated
* Patients who are known to be pregnant

Primary outcomes:
measure: Percentage of Subjects Whose VLE Results Correlates With the Histology Results for T1 EAC Depth of Invasion
timeFrame: 1 day
measure: Percentage of Subjects Whose VLE Results Correlates With the Histology Results for Staging T1 EAC
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Cadman L Leggett, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05583643: Clinical & Biochemical Effect of Atorvastatin in Nano Particles Gel in Periodontitis Treatment
Official title: Syringeable Atorvastatin Loaded Eugenol Enriched PEGylated Cubosomes In-situ Gel for the Intra-pocket Treatment of Periodontitis: Statistical Optimization and Clinical Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Periodontitis
Keywords: Periodontitis
Non-surgical treatment
Atorvastatin
Phase 1 therapy
Lead sponsor: Misr University for Science and Technology
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Periodontitis is a destructive chronic inflammatory disease characterized by periodontium damage and pocket formation between the tooth and the gingival margin resulting in ultimate tooth loss. Various topical anti-inflammatory drugs were used to treat inflammation in periodontitis. Introducing atorvastatin as a novel remedy for periodontitis treatment necessitates developing a syringeable modified delivery system capable of targeting inflammation within the periodontal pockets.


Eligibility criteria: Inclusion Criteria:

* Systemically healthy patients
* Patients with moderate periodontitis

Exclusion Criteria:

* Pregnant women
* Lactating women
* Patients with chronic diseases

Primary outcomes:
measure: Probing depth
timeFrame: 6 weeks
measure: Bleeding index
timeFrame: 6 weeks
measure: Plaque index
timeFrame: 6 weeks
Secondary outcomes:
measure: Assessment of transforming growth factor in gingival crevicular fluid
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Misr University for Science and Technology (MUST)
Study officials:
References: