louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05581966: Wound Assessment Using Spectral Imaging EU/UK
Official title: Wound Assessment Using Spectral Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetic Foot
Diabetic Foot Ulcer
Lead sponsor: SpectralMD
Sponsor class: INDUSTRY
First posted: 2022-10-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with DFUs undergoing SWC treatment

Brief summary: During the observational, non-interventional study, at Baseline Study Visit (BSV) subjects will be screened and consented. Eligible subjects will undergo imaging with the DeepView device. Pre- and post-debridement images will be obtained (if debridement performed per SOC), as well as reviewing medical history and physical assessments.

Additional Study Visits (SVs) will be performed when patient returns to the clinic for Routine Clinic Visit for up to 12 weeks or wound closure. During these visits DeepView imaging will occur pre- and post-debridement, and the status of the subject's treatment will be recorded.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old.
* Subject has an ulcer, or a slow healing wound that is full thickness for at least 4 weeks, below the malleolus, in the presence of Diabetes.
* The target ulcer will be the largest ulcer if two or more eligible DFUs are present and will be the only one evaluated in the study.
* The target ulcer is planned to undergo standard wound care (SWC) therapy (See 8.6 Standard Wound Care (SWC) Therapy).
* Subject understands and is willing to participate in the clinical study and can comply with required visits.

Exclusion Criteria:

* Target ulcer is deemed by the investigator to be caused by a medical condition other than diabetes.
* Target ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
* Eligible DFU has associated untreated acute osteomyelitis or active infection
* Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10mg daily dose), or cytotoxic chemotherapy.
* Subjects on any investigational drug(s) or device(s) within 30 days preceding initial study visit.

Primary outcomes:
measure: Data Collection
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Abbotstown
country: Ireland
facility: Connolly Hospital, Diabetic Day Centre
state: Dublin
Study officials:
References:
Clinical trial NCT03301766: Adjunctive 5% Lidocaine Patches for Acute Non-radicular Low Back Pain in Emergency Department Patients
Official title: Adjunctive 5% Lidocaine Patches in the Treatment of Acute Non-radicular Low Back Pain in Patients Discharged From the Emergency Department
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Low Back Pain
Keywords: lidocaine
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
First posted: 2017-10-04
Enrollment: 0
Sex: ALL
Minimum age (years): 24
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the addition of lidocaine % transdermal patches to standard therapy in the treatment of acute non-radicular low back pain in patients discharged from the Emergency Department. In addition to standard therapy, half of the participants will receive medicated patches while the other half will receive non-medicated patches.

Detailed description: Low back pain is a common emergency department (ED) chief complaint. Multiple therapies have been evaluated in the treatment of ED patients with low back pain including acetaminophen, NSAIDS, opioids, steroids, and muscle relaxants.

Lidocaine is a local anesthetic that can be administered by various routes. It is used in a transdermal patch for the treatment of pain. It is commonly used for focal causes of pain, including low back pain. The addition of lidocaine 5% patches to standard low back pain therapy has not been rigorously evaluated, although it is frequently used.

Eligibility criteria: Inclusion Criteria:

* pain originating between the lower border of the scapulae and the upper gluteal folds
* treating ED physician plan for discharge of the patient

Exclusion Criteria:

* radicular pain defined as pain radiating below the gluteal folds
* direct trauma to the back within previous month
* pain of greater than 2 weeks duration or greater than 1 LBP episode per month in the past 3 months
* patient being pregnant or lactating; no access to phone or ability to participate in follow-up phone calls
* known allergy to lidocaine or skin breakdown over site of pain
* treating physician plan for opioid prescription (tramadol, codeine, hydrocodone)
* personal history of malignancy, fever (temperature greater than 37.9ºC), or previous spinal surgery
* patients who are detainees
* previous enrollment in the study

Primary outcomes:
measure: Numerical Pain Rating Scale (NRS)
timeFrame: 1 week
Secondary outcomes:
measure: Roland-Morris-24 back pain disability scale
timeFrame: 1 week and 1 month
measure: Numerical Pain Rating Scale (NRS)
timeFrame: 1 month
Other outcomes:
measure: Repeat visits
timeFrame: 1 week and 1 month
Locations:
city: Chicago
country: United States
facility: John H Stroger Jr Hospital of Cook County
state: Illinois
Study officials:
References:
Clinical trial NCT00866866: The Use of Oral N-Acetyl Cysteine for the Treatment of Chronic Sinonasal Symptoms
Official title: The Use of Oral N-Acetyl Cysteine for the Treatment of Chronic Sinonasal Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Sinonasal Symptoms
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2009-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic sinonasal symptoms (CSNS), such as coughing, throat clearing, nasal obstruction, crusting, dryness and discharge are extremely common in the general population. Although the physical symptoms are readily apparent, the psychosocial impact is often overlooked. Depression, anxiety, fear of social interaction, impaired personal relationships and decreased performance at work have all been associated with CSNS, often leading to multiple, frequent visits to the patient's primary care physician. A variety of clinical studies have shown that health-related quality of life (HRQoL) is significantly impaired in people with CSNS, with depressive symptoms being particularly common.

CSNS may be due, in part, to tenacious nasal and paranasal secretions. It is therefore conceivable that a mucolytic may thin these secretions and improve mucociliary clearance, thereby reducing CSNS. N-acetylcysteine (NAC) is the most widely used mucolytic agent, particularly in patients with cystic fibrosis (CF), and has been documented as the most effective of the mucokinetic agents. Our group wishes to examine the use of NAC as a treatment for CSNS by testing the hypothesis that oral NAC reduces symptoms of CSNS compared to placebo.


Eligibility criteria: Inclusion Criteria:

* one or more the following symptoms: nasal stuffiness, nasal dryness or crusting, nasal congestion, discolored nasal discharge, or thick nasal discharge, for four or more days a week in the preceding two weeks

Exclusion Criteria:

* poorly controlled asthma
* cystic fibrosis
* chronic obstructive pulmonary disease (COPD)
* severe coronary artery disease
* vasculopathy
* poorly controlled diabetes
* poorly controlled hypertension
* women who are breastfeeding

Primary outcomes:
measure: Sinonasal Outcomes Test (SNOT) - 22
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Warren Yunker, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03381066: A Phase III, Randomized, Multi-center Study to Determine the Efficacy of the Intercalating Combination Treatment of Chemotherapy and Gefitinib or Chemotherapy as Adjuvant Treatment in NSCLC With Common EGFR Mutations.
Official title: A Phase III, Randomized, Multi-center Study to Determine the Efficacy of the Intercalating Combination Treatment of Chemotherapy and Gefitinib or Chemotherapy as Adjuvant Treatment in NSCLC With Common EGFR Mutations.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Completely Resected NSCLC With Common EGFR Mutations
Keywords: NSCLC
EGFR
adjuvant
gefitinib
intercalating
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 225
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the efficacy of intercalating chemotherapy (gefitinib and pemetrexed/cisplatin) and chemotherapy (navelbine/cisplatin) in completely resected NSCLC with common EGFR mutations.


Eligibility criteria: Inclusion Criteria:

1. Completely resected non-squamous cell NSCLC with stage IIa to IIIb (excluding N3) according to Version 8 of the IASLC Staging Manual in Thoracic Oncology
2. Tumors with common EGFR mutations (19del or L858R)
3. Adequate oran function

Exclusion Criteria:

1. Patients who were exposed to the chemotherapy or EGFR TKIs for NSCLC.
2. Patients with interstitial lung disease

Primary outcomes:
measure: disease-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 year
measure: Number of participants with treatment-related adverse events as assessed by CTCAE4.0
timeFrame: 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Oncology, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT01211366: Use of Cell Salvage Post-operatively in Infants to Decrease Use of Allogeneic Blood Product Transfusions
Official title: Post-operative Infusion of Intra-operative Cell Salvage Reduces Allogeneic Blood Product Transfusions and Volume Resuscitation in Pediatric Cardiac Surgery and Improves Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transfusion
Keywords: cell saver
allogeneic RBCs
washed cells
PRBC transfusion
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2010-09-29
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transfusion of washed intra-operative cell salvage post-operatively in the PCICU can be performed safely without increased risk of bleeding or release of inflammatory mediators. This will reduce the need for allogeneic blood products as well as crystalloid and colloid infusions and thus decrease the length of ventilation and intensive care duration for these infants.


Eligibility criteria: Inclusion Criteria:

* 1. Weight \< or = 20Kg;
* 2. Cardiac surgery with CPB at URMC;
* 3. informed consent

Exclusion Criteria:

* 1. weight \> 21 Kg;
* inability to obtain consent;
* non-English speaking

Primary outcomes:
measure: Comparison of volume of allogeneic blood products and crystalloid/colloid infusions between groups
timeFrame: 2 years
Secondary outcomes:
measure: comparison of bleeding, use of coagulant products, and inflammatory markers between groups
timeFrame: 2 years
measure: comparison of clinical outcomes between groups
timeFrame: 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT05219526: System Accuracy of 12 Bloog Glucose Monitoring Systems
Official title: Evaluation of the System Accuracy of 12 Blood Glucose Monitoring Systems According to ISO 15197:2015
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Institut fur Diabetes Karlsburg GmbH
Sponsor class: OTHER
Collaborators: name: Aktivmed GmbH
name: Beurer GmbH
name: IME-DC GmbH
name: Medisana GmbH
First posted: 2022-02-02
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The system accuracy of 12 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 in the course of the year 2022.


Eligibility criteria: Inclusion Criteria:

* Male or female, with clinical indication for blood glucose measurement
* Signed informed consent form
* Minimum age of 18 years
* Subjects are legally competent and capable to understand character, meaning and consequences of the study.

Exclusion Criteria:

* Pregnancy or lactation period
* Severe acute disease (at the study physician's discretion)
* Severe chronic disease with inherent risk of aggravation by the procedure (at the study physician's discretion)
* Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
* A current constitution that does not allow participating in the study (e.g. hematocrit out of BGM specifications, medication known to influence blood glucose measurements; see Appendix A of ISO 15197)
* Being unable to give informed consent
* \< 18 years
* Legally incompetent

Primary outcomes:
measure: Measurement performance: System accuracy
timeFrame: 4-6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Karlsburg
country: Germany
facility: Institut für Diabetes Karlsburg GmbH
state: Mecklenburg Vorpommern
Study officials:
affiliation: Institut fur Diabetes Karlsburg GmbH
name: Eckhard Salzsieder, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04457466: Assessment of the Effects of Extensive Somatosensory Training on Pain Processing
Official title: Assessment of the Effects of Extensive Sensorimotor Training on Pain Processing
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Musculoskeletal Pain
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Lundbeck Foundation
name: Danish National Research Foundation
First posted: 2020-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy men and women Speak and understand English.

Brief summary: Persistent pain may lead to several alterations in the brain activity and sensory perception (i.e. pain). Around 80% of professional musicians experience prolonged episodes of musculoskeletal pain throughout their careers, a percentage that is four times higher than in the general population. With this background, the intended experiment aims at understanding the role of several biological factors associated to sensorimotor training that can lead to alteration of the brain activity and, consequently, pain processing.


Eligibility criteria: Inclusion Criteria:

Healthy men and women Speak and understand English.

General exclusion criteria are:

* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous neurologic or mental illnesses
* Presence of a history of trauma or neurologic entrapment syndromes to the arm regions.
* Lack of ability to cooperate
* Frequent computer gamer ( \> 9 hours/week)

Primary outcomes:
measure: Pain rating
timeFrame: Changes from baseline measured at day 3 and day 8
measure: Cortical Sensory Evoked Potentials
timeFrame: Changes from baseline measured at day 3 and day 8
measure: Motor Evoked Potentials
timeFrame: Changes from baseline measured at day 3 and day 8
measure: Brain connectivity
timeFrame: Changes from baseline measured at day 3 and day 8
Secondary outcomes:
measure: Questionnaires
timeFrame: Changes from baseline measured at day 3 and day 8
measure: Pressure pain thresholds
timeFrame: Changes from baseline measured at day 3 and day 8
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
state: Nordjylland
Study officials:
References:
Clinical trial NCT05883566: Comparison of Dental Pain Response in Children
Official title: Comparison of Behavioral , Physiological and Self-reported Pain Responses in Children With Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Lead sponsor: Altamash Institute of Dental Medicine
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study involves the observation of the child's behavior during a dental treatment procedure. This allows for the evaluation of the child's experience of pain and discomfort through their facial expressions, body movements, and vocalizations during the procedure.


Eligibility criteria: Inclusion Criteria:

* Age range: Children aged between 6-12 years old (or any other specific age range) will be included in the study.
* Dental pain: Participants who have been diagnosed with dental pain by their dentist will be included.
* Consent: Informed consent must be obtained from the child and their parents or guardians before the study.

Exclusion Criteria:

* Participants with existing medical or psychological conditions that could affect the pain response for instance, children with chronic pain conditions or with a history of anxiety or depression.
* Participants who have taken any pain medication within the past 24 hours as this could interfere with the pain response.

Primary outcomes:
measure: Post operative pain
timeFrame: immediately after completion of the treatment within 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Hira
state: Sindh
city: Karachi
country: Pakistan
facility: Hira Danish
state: Sindh
Study officials:
References:
Clinical trial NCT03478826: Creation of a Biospecimen Repository From Patients With Interstitial Lung Diseases (ILD)
Official title: Creation of a Biospecimen Repository From Patients With Interstitial Lung Diseases (ILD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Disease
Keywords: ILD
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 635
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of ILD or any fibrotic disease of the lung. A diagnosis of pneumonia and healthy volunteers will also be included as a control group.

Brief summary: To develop a repository of blood samples from patients with ILD to support future studies into the development of such biomarkers. Patients with pneumonia and healthy patients will also be recruited as a control group.

Detailed description: The proposed biospecimen repository would be derived from patients diagnosed with ILD. This is to include 500 patients in the repository, with each patient contributing one blood sample. Patients with pneumonia and healthy patients will also be recruited as a control group.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of ILD or any fibrotic disease of the lung or a diagnosis of pneumonia
* Patients willing to provide written informed consent

Exclusion Criteria:

* Unwillingness/unable to give blood samples

Primary outcomes:
measure: Future Disease Management
timeFrame: 1 visit
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Eva M Carmona Porquera, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00148226: ICIBS Trial - Improving Patient Information About Bowel Cancer Screening - a Decision Aid Trial
Official title: Randomized Controlled Trial of Patient Decision Aids for Faecal Occult Blood Test Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer Screening
Keywords: Decision Aid
Faecal Occult Blood Test
Colorectal Cancer Screening
Informed Decision-making
Lead sponsor: University of Sydney
Sponsor class: OTHER
First posted: 2005-09-07
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: This project has been completed and consisted of a randomised trial of six tailored decision aids giving patients evidence-based information about faecal occult blood test screening for bowel cancer. 314 Australians aged between 50-74 years were recruited from five general practices and randomised to received either the tailored decision aid with age-gender and family history specific information and values clarification exercise or a standard government information sheet.

The decision aid significantly increased the proportion of people who were informed participants in the screening program.


Eligibility criteria: Inclusion Criteria:

* People aged 50-74 years who were eligible for FOBT screening under current Australian guidelines and had not had screening for colorectal cancer in the preceding two years

Exclusion Criteria:

* Poor English, impaired cognition, significant comorbidity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: University of Sydney
state: New South Wales
Study officials:
affiliation: University of Sydney
name: Lyndal J Trevena, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Les Irwig, PhD
role: STUDY_DIRECTOR
References:
citation: Trevena LJ, Irwig L, Barratt A. Randomized trial of a self-administered decision aid for colorectal cancer screening. J Med Screen. 2008;15(2):76-82. doi: 10.1258/jms.2008.007110.