louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02513784: Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal Microbiome
Official title: Pilot Randomized Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal and Gastric Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Adenocarcinoma
Barrett's Esophagus
Reflux Esophagitis
Keywords: Microbiome
Esophagus
Endoscopy
Mouthwash
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2015-08-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine mouthwash can alter the esophageal and gastric cardia microbiome

Detailed description: Patients scheduled for upper endoscopy for clinical indications will be randomized to 3 weeks of either no treatment or use of twice daily chlorhexidine mouthwash leading up to the endoscopy. There will be 2-3 study visits, at Day 0 and Day 21, and for those subjects in the mouthwash arm, a final visit 1-2 weeks following the Day 21 visit. Subjects will be required to fast overnight prior to the visits on Days 0 and 21.

Eligibility criteria: Inclusion Criteria:

* Age \>18
* Scheduled for upper endoscopy for clinical indications
* No allergy or other contraindication to chlorhexidine

Exclusion Criteria:

* Use of proton pump inhibitors or H2 receptor antagonists within 1 month of enrollment. Acid suppressant medications raise the gastric pH and can dramatically alter the gastric and esophageal microbiome.
* History of upper gastrointestinal cancer
* History of histologically proven Barrett's esophagus
* History of antireflux or bariatric surgery, or other gastric or esophageal surgery
* Use of antimicrobial mouthwash within 1 month of enrollment
* Use of antibiotics or immunosuppressant medications within 3 months of enrollment
* Use of steroid inhalers or nasal sprays within 1 month of enrollment
* HIV or other immunosuppressed states or conditions (e.g. active malignancy)
* Pregnant or breast feeding
* Inability to give informed consent

Primary outcomes:
measure: Reduction of F. Nucleatum in Saliva
timeFrame: 21 days
measure: Difference in Esophageal F. Nucleatum Between Experimental Group and no Intervention Group
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Assistant Professor of Medicine and Epidemiology
name: Julian A. Abrams, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Annavajhala MK, May M, Compres G, Freedberg DE, Graham R, Stump S, Que J, Korem T, Uhlemann AC, Abrams JA. Relationship of the Esophageal Microbiome and Tissue Gene Expression and Links to the Oral Microbiome: A Randomized Clinical Trial. Clin Transl Gastroenterol. 2020 Dec;11(12):e00235. doi: 10.14309/ctg.0000000000000235.
Clinical trial NCT00871884: Evaluation of Two Treatments for Chronic Post Concussion Syndrome
Official title: The Role of Anxiety Sensitivity in the Maintenance of Chronic Post Concussion Symptoms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Post Concussion Syndrome
Head Injury
Keywords: Post Concussion Syndrome
Cognitive Behavioral Therapy
Anxiety Sensitivity
Mild Head Injury
Psychotherapy
Chronic Post Concussion Symptoms
Lead sponsor: Simon Fraser University
Sponsor class: OTHER
First posted: 2009-03-30
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate factors that are associated with prolonged recovery from mild head injury. The investigators are particularly interested in defining the impact of anxiety related variables, such as health anxiety and anxiety sensitivity in the maintenance of symptoms.

A further goal of the study is the evaluation of two treatment methods that have been proposed to be effective in reducing the impact of post concussion symptoms. The investigators hypothesize that a treatment which is directly focused on changing these anxiety related variables will be more effective than one that does not.


Eligibility criteria: Inclusion Criteria:

* Mild Head Injury at least 3 months prior to treatment
* age 19 to 65 years
* grade 12 education
* proficiency with English language

Exclusion Criteria:

* Current Litigation

Primary outcomes:
measure: Post Concussion Symptom Checklist
timeFrame: 0 weeks, 2 weeks, 4 weeks, 6 weeks
Secondary outcomes:
measure: Anxiety Sensitivity Index
timeFrame: 0 weeks, 2 weeks, 4 weeks, 6 weeks
measure: State Trait Anxiety Inventory
timeFrame: 0 weeks, 2 weeks, 4 weeks, 6 weeks
measure: Zung Self Rated Depression Scale
timeFrame: 0 weeks, 2 weeks, 4 weeks, 6 weeks
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Clinical Psychology Centre, Simon Fraser University
state: British Columbia
Study officials:
affiliation: Human Neuropsychology Laboratory, Department of Psychology, Simon Fraser University
name: Kevin C Whitfield, M.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: Human Neuropsychology Laboratory, Department of Psychology, Simon Fraser University
name: Allen E Thornton, Ph.D.
role: STUDY_DIRECTOR
affiliation: Department of Psychology, Simon fraser University
name: Alex P Chapman, Ph.D.
role: STUDY_DIRECTOR
affiliation: Department of Psychology, Simon Fraser University
name: David Cox, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04938284: Combining PAS to Non-invasive VNS
Official title: The Synergistic Effect of Paired Associative Stimulation and Vagus Nerve Stimulation on Motor-evoked Potential Potentiation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Plasticity
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Vagus nerve stimulation (VNS) and paired associative stimulation (PAS) have been shown to have efficacy in improving the results of motor rehabilitation after stroke and spinal cord injury, respectively. Here we will investigate in healthy subjects the synergistic effect of these stimulation modalities on motor-evoked potential (MEP) potentiation.


Eligibility criteria: Exclusion Criteria:

* contraindications to TMS (e.g. brain pathology, implanted devices)
* contraindications to MRI (e.g. MRI incompatible implants)
* continuous use of CNS-active drugs
* neurological, psychiatric or cardiovascular disease
* drug abuse

Primary outcomes:
measure: Motor evoked potential (MEP) potentiation
timeFrame: 0 minutes after the stimulation protocol
measure: Motor evoked potential (MEP) potentiation
timeFrame: 30 minutes after the stimulation protocol
measure: Motor evoked potential (MEP) potentiation
timeFrame: 60 minutes after the stimulation protocol
measure: Motor evoked potential (MEP) potentiation
timeFrame: 90 minutes after the stimulation protocol
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
References:
citation: Shulga A, Lioumis P, Kirveskari E, Savolainen S, Makela JP. A novel paired associative stimulation protocol with a high-frequency peripheral component: A review on results in spinal cord injury rehabilitation. Eur J Neurosci. 2021 May;53(9):3242-3257. doi: 10.1111/ejn.15191. Epub 2021 Mar 29.
citation: Dawson J, Pierce D, Dixit A, Kimberley TJ, Robertson M, Tarver B, Hilmi O, McLean J, Forbes K, Kilgard MP, Rennaker RL, Cramer SC, Walters M, Engineer N. Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke. Stroke. 2016 Jan;47(1):143-50. doi: 10.1161/STROKEAHA.115.010477. Epub 2015 Dec 8.
citation: Haakana P, Natkynmaki A, Kirveskari E, Makela JP, Kilgard MP, Tarvainen MP, Shulga A. Effects of auricular vagus nerve stimulation and electrical earlobe stimulation on motor-evoked potential changes induced by paired associative stimulation. Eur J Neurosci. 2024 Oct;60(8):5949-5965. doi: 10.1111/ejn.16539. Epub 2024 Sep 11.
Clinical trial NCT01322984: Cognitive and Emotional Processing of Social Stimuli in Children and Youth With Autism Spectrum Disorder
Official title: Cognitive and Emotional Processing of Social Stimuli in Children and Youth With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: ASD
Startle
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
First posted: 2011-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Children and youth diagnosed with autism spectrum disorder (ASD) have been shown to react abnormally to social stimuli, especially to human faces. Children and youth with ASD show less interest in social stimuli, and may even avoid looking at or interact with such stimuli. It has been proposed that social stimuli elicit reactions like fear and stress in individuals with ASD, and this explains the lack of interest and avoidance. The present project investigates this hypothesis.


Eligibility criteria: For ASD group:

Inclusion Criteria:

* Diagnosed with autism spectrum disorders

Primary outcomes:
measure: The eyeblink of the Startle reflex is measured.
timeFrame: The startle reflex will be measured in relation to picture presentations during the experiment (e.g. day 1).
Secondary outcomes:
Other outcomes:
Locations:
city: Tromso
country: Norway
facility: Department of Psychology, University of Tromso
state: Troms
Study officials:
References:
Clinical trial NCT02053584: Dario™ Blood Glucose Monitoring System - User Performance Evaluation
Official title: Dario™ Blood Glucose Monitoring System - User Performance Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: LabStyle Innovations Ltd.
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 230
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study is performed to evaluate the accuracy of blood glucose level results obtained from fingertip using Labstyle Dario Blood Glucose Monitoring System (BGMS) compared to reference equipment (YSI 2300 STATPLUS) and to evaluate the ease of use of the Dario Device by the lay-person.

The participants will review the Dario user manual and guide and will be requested to operate the Dario BGMS and perform their own glucose blood test, after which they will be asked to complete a questionnaire. As reference the participants will be tested by professional caregivers both using the Dario BGMS and by YSI 2003.

Detailed description: Device accuracy will be assessed based on the acceptance criteria of ISO 15197:2003 which states: "The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dL of the results of Reference method at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL)".

Eligibility criteria: Inclusion Criteria:

* Male or female between the age 18 and 80
* Type 1 and Type 2 diabetes

Exclusion Criteria:

* Drug and alcohol abuse
* Investigator discretion

Primary outcomes:
measure: BGMS Accuracy Assessment When Used by Layperson
timeFrame: Within 6 seconds of applying blood drop to strip
Secondary outcomes:
measure: Evaluation of the Ease of Use of the Dario BGMS by the Lay-person
timeFrame: Within a couple of hours from the time labelling material was provided to the subject
Other outcomes:
Locations:
Study officials:
affiliation: Wolfson Medical Center
name: Julio Vainstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06196684: Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery
Official title: Early Safety and Clinical Efficacy of Mitral Allografts in Patients With Primary Tricuspid Valve Disease Scheduled for Tricuspid Valve Replacement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allografts
Tricuspid Valve Insufficiency
Lead sponsor: Chelyabinsk Regional Clinical Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with primary tricuspid valve disease

Brief summary: The aim of the study is to evaluate early safety and clinical efficacy of mitral allografts in tricuspid valve replacement for primary tricuspid valve diseases.

Detailed description: Early safety (morbidity, mortality rate, freedom from any valve related complication) along with mid-term clinical efficacy ( mid-term survival, freedom from reoperation, repeat endocarditis and other valve related complication ) is going to be evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention.
* Intraoperative findings suggested for tricuspid valve replacement rather than repair.

Exclusion Criteria:

* Pregnancy
* Confirmed active drug addiction
* Progressive HIV-infection
* HIV-infected patients with CD4-cells count less than 250
* Patients with secondary tricuspid valve pathology (left-sided valve disease)
* LV Ejection fraction less than 50%

Primary outcomes:
measure: Mortality (all cause and valve-related)
timeFrame: 30-day period
Secondary outcomes:
measure: Neurologic events
timeFrame: 30-day period
measure: Bleeding and transfusions
timeFrame: 30 days
measure: Cardiac structural complications
timeFrame: 30 days
measure: Acute kidney injury
timeFrame: 30 days
measure: Allograft valve dysfunction
timeFrame: 30 days
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Department of Cardiac Surgery
Study officials:
References:
Clinical trial NCT01194284: Surveillance Study of Patients With Newly Diagnosed Osteosarcoma
Official title: Observational, Noninterventional Surveillance Study of Patients With Newly Diagnosed Osteosarcoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteosarcoma
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-09-02
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice.

Brief summary: This study is an observational safety surveillance study designed to prospectively assess patients with high-grade osteosarcoma who are candidates for treatment with mifamurtide within the context of prevailing standard oncology practice


Eligibility criteria: Inclusion Criteria

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

* Male or female aged 2 to 40 years
* Confirmed pathological diagnosis of newly-diagnosed, nonmetastatic, resectable, primary, high-grade osteosarcoma
* Have completed definitive surgery (or other local ablation technique)
* Have a treatment regimen that includes mifamurtide and a minimum of 2 recognized chemotherapy agents in the treatment of osteosarcoma (cisplatin, doxorubicin, high-dose methotrexate or ifosfamide)
* Organ function deemed satisfactory to receive planned chemotherapy containing at minimum 2 of the recognized chemotherapy agents in the treatment of osteosarcoma
* Voluntary Written Consent

Exclusion Criteria

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

* Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period
* History of pericarditis or pleuritis
* Have low-grade osteosarcoma or parosteal or periosteal sarcoma
* Have osteosarcoma associated with Paget's disease
* Current treatment with any anticancer investigational products at the time of enrollment in this study

Primary outcomes:
measure: Short-term safety profile of mifamurtide during treatment (mifamurtide in combination with chemotherapy)
timeFrame: 36 weeks
measure: The long-term safety profile of mifamurtide during and following treatment (mifamurtide in combination with chemotherapy)
timeFrame: Up to 5 years from the last dose of mifamurtide or until death
Secondary outcomes:
measure: Disease-free survival
timeFrame: Up to 5 years from the last dose of mifamurtide or until death
measure: Overall Survival
timeFrame: Up to 5 years from the last dose of mifamurtide or until death
Other outcomes:
Locations:
city: Wien
country: Austria
facility: AKH Wien Universitätsklinik für Innere Medizin I Klinische Abteilung für Onkologie
Study officials:
affiliation: Millennium Pharmaceuticals, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06169384: Endoscopic Partial Adenoidectomy Versus Total Adenoidectomy Regarding Rate of Recurrence and Relief of Symptoms
Official title: Endoscopic Partial Adenoidectomy Versus Total Adenoidectomy Regarding Rate of Recurrence and Relief of Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adenoidal Hypertrophy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of nasal obstruction.


Eligibility criteria: Inclusion Criteria:

* .all patients with adenoid hypertrophy causing airway obstruction.

Exclusion Criteria:

* 1. Chlidren known to have cleft palate ,submucous cleft palate or other medical problems causing velopharyngeal insufficiency.
* 2 . Systemic medical problems interfering with surgery.
* 3 . Refusal of parents to participate.
* 4. Craniofacial abnormalities.
* 5. Down syndrome.

Primary outcomes:
measure: Efficacy of partial adenoidectomy versus total adenoidectomy regarding rate of recurrence and relief of nasal obstruction.
timeFrame: 1 to 2 years .
measure: Incidence of recurrence using fibro-optic evaluation
timeFrame: 1 to 2 years .
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: AssiutU
Study officials:
References:
citation: 1. Jervis-Bardy, J.; Department of Otolaryngology, Arkansas Children's Hospital, cLittle Rock, AR, United States. Journal of Craniofacial SurgeryVolume 30, Issue 5, Pages E454 - E4602019.
citation: 1. Kummer AW, Lee L. Evaluation and treatment of resonance disorders. Language, Speech, and Hearing Services in Schools, 27:271-281
citation: Saunders NC, Hartley BE, Sell D, Sommerlad B. Velopharyngeal insufficiency following adenoidectomy. Clin Otolaryngol Allied Sci. 2004 Dec;29(6):686-8. doi: 10.1111/j.1365-2273.2004.00870.x.
Clinical trial NCT06496984: Valutazione All'Ingresso Del Rischio Nutrizionale in Pazienti Ricoverati Nel Reparto di Medicina Interna (AMIDO)
Official title: Valutazione in Ingresso Del Rischio Nutrizionale Del Paziente in SC Medicina Interna Del P.O. di Acqui Terme in Regime di Ricovero: Presa in Carico Nutrizionale Per Ottimizzare l'Outcome di Patologia Acuta e Monitoraggio Nel Post-ricovero
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Hospitalized Patient
Lead sponsor: Azienda Sanitaria Locale di Alessandria
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to identify the risk of malnutrition in patients admitted to the Internal Medicine departments using the MUST screening tool. Additional aspects are to evaluate malnourished patients' characteristics and effectiveness of an early nutritional programme started during hospitalization.

Detailed description: Malnutrition is defined as a nutritional state characterized by an excess or deficient intake of nutrients. This condition may result in a change in body composition and in organic disfunctions. Malnutrition in hospitalized patients is a condition prevalent worldwide affecting between 20% and 50% of patients at admission, with further increase expected during hospitalization. Patients hospitalized in internal medicine departments are frequently older with multimorbidity and polypharmacy, so very likely to be malnourished, but the prevalence and determinants of malnutrition remain unclear.

In AMIDO study, all patients with MUST 1 and 2 will be sent to the a dietitian. The clinician will act on the patient's characteristics by providing different dietary therapies, such as oral nutritional supports (ONS), extra nutritional cares, diet changes without supplements and artificial nutrition.

Eligibility criteria: Inclusion Criteria:

* Patients admitted from 1st January 2023 to 31th May 2023 at the Internal Medicine Department of the Monsignor Giovanni Galliano Hospital in Acqui Terme of the Alessandria ASL.

Exclusion Criteria:

* none

Primary outcomes:
measure: Risk of malnutrition
timeFrame: Before the intervention (Baseline/T0) and at the hospital discharge, an average of 8 days after (Final/T1)
Secondary outcomes:
measure: Clinical conditions and malnutrition
timeFrame: Before the intervention (Baseline/T0) and at the hospital discharge, an average of 8 days after (Final/T1)
measure: Gender and malnutrition
timeFrame: Before the intervention (Baseline/T0) and at the hospital discharge, an average of 8 days after (Final/T1)
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Azienda Sanitaria Locale di Alessandria (ASL AL)
state: Piedmont
Study officials:
affiliation: Azienda Sanitaria Locale di Alessandria (ASL AL)
name: Paola Gnerre, MD
role: PRINCIPAL_INVESTIGATOR
References: