louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03000699: Efficacy of Cognitive Bias Modification in Residential Treatment for Addiction
Official title: Efficacy of Cognitive Bias Modification in Residential Treatment for Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Dependence
Keywords: cognitive bias modification
interpretation bias
suicidal ideation
depression
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: American Foundation for Suicide Prevention
First posted: 2016-12-22
Enrollment: 88
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: The purpose of this study is to determine whether computer bias modification for interpretation bias (CBM-I) is effective in the reduction of suicidal ideation in substance use disorders.

Detailed description: Eighty-eight adult inpatients completing residential treatment in the Addictions Services at the Centre for Addiction and Mental Health (CAMH) will be randomized to receive CBM-I daily for one week, adjunct to the residential psychosocial treatment or to an assessment-only control condition. Participants will complete clinical measures consisting of interviews and questionnaires measuring suicidal ideation, hopelessness, depression, negative affect, and interpretation biases before, during and after treatment.

Eligibility criteria: Inclusion Criteria:

* Exhibit moderate suicide risk or greater
* Be enrolled in the Addictions Services inpatient program
* Fluent in reading English
* Capacity to give informed consent

Exclusion Criteria:

* A lifetime diagnosis of a psychotic or bipolar disorder
* Significant neurological disorder or psychical illness likely to interfere with participation
* Psychotropic medication changes within the past two weeks

Primary outcomes:
measure: Columbia-Suicide Severity Rating Scale, Screen Version (C-SSRS)
timeFrame: Seven days
Secondary outcomes:
measure: Beck Hopelessness Scale (BHS)
timeFrame: Seven days
measure: Beck Depression Inventory II (BDI-II)
timeFrame: Seven days
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Seven days
measure: Scrambled Sentences Tests
timeFrame: Seven days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Lena C Quilty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01067599: Novel Determinants and Measures of Smokeless Tobacco Use: Study 2
Official title: Novel Determinants and Measures of Smokeless Tobacco Use: Study 2 Effects of Switching Levels of Nicotine and TSNA in Products on Smokeless Tobacco Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Nicotine Dependence
Keywords: Biomarkers of tobacco exposure
Smokeless Tobacco
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute on Drug Abuse (NIDA)
First posted: 2010-02-11
Enrollment: 278
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: The research project will determine the level of nicotine in ST products that will lead to the greatest reduction in toxicant exposure

Detailed description: This is a randomized, multi-site trial determining the effects of switching smokeless tobacco (ST) users to lower toxicant ST products which vary in nicotine levels on biomarkers of exposure and patterns of use. ST users will undergo a two week baseline assessment period and then randomly assigned to one of three oral tobacco products (lower NNK plus NNN product with three different levels of nicotine) for a period of 8-weeks. Follow-up will occur at 9 and 20 weeks.

Eligibility criteria: Inclusion Criteria:

1. Using a consistent and daily amount of ST with specific nicotine and tobacco-specific nitrosamine (TSNA) levels for the past year;
2. In good physical health (no unstable medical condition);
3. Stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).

Exclusion Criteria:

1. Subjects must not be currently using other tobacco or nicotine products.
2. Female subjects cannot be pregnant or nursing.

Primary outcomes:
measure: 1. To determine if switching to ST products with reduced toxicant levels will result in reduction of biomarkers of exposure and toxicity. 2. To determine the nicotine levels of ST that would lead to the greatest reduction in tobacco toxicant exposure.
timeFrame: 8 weeks
Secondary outcomes:
measure: To determine the extent to which varying low nicotine ST products leads to compensatory tobacco use.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03774199: NightOwl Pulse Oximeter Calibration Study
Official title: NightOwl Pulse Oximeter Calibration Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulse Oximeter Calibration
Lead sponsor: Ectosense NV
Sponsor class: INDUSTRY
First posted: 2018-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Calibration of a software module that computes SpO2 based on photoplethysmography (PPG) traces acquired by a reflectance-based pulse oximeter which can be placed on the index finger or the forehead.

The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601- 2-61:2011)


Eligibility criteria: Inclusion Criteria:

* healthy subjects (ASA 1 and ASA 2) upon signing the informed consent. (ASA : american society of anesthesiologist's health score)

Exclusion Criteria:

* smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhaemoglobin levels.
* individuals subject to conditions that result in elevated levels of methaemoglobin.
* individuals with arterial cannulation or hypoxia at FiO2 = 0,21

Primary outcomes:
measure: A_rms determination
timeFrame: Within 3 months after subject recruitment, the calibration and ARMS determination should have been performed.
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: CMC
state: Limburg
Study officials:
References:
Clinical trial NCT06032299: Dual Implant Versus Single Implant Distal End of Femur
Official title: Pilot for Dual Implant Versus Single Implant Distal End of Femur (pDISIDE Femur)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Femur Fracture
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.


Eligibility criteria: Inclusion Criteria:

* Femur fracture distal to the femoral diaphysis.
* Operative treatment within 72 hours of presenting to the treating hospital.
* Patient was previously ambulatory.
* Fracture amendable to either single or dual implant fixation.
* Informed consent can be obtained from the patient, family member, or power of attorney.

Exclusion Criteria:

* Associated major lower extremity fracture.
* Ongoing infection.
* History of metabolic bone disease (Paget's, etc).
* Pathologic fracture.
* Open fracture.
* Severe cognitive impairment (Six Item Screener with 3 or more errors).
* Stage 5 Parkinson's disease.
* Significant femoral bone loss requiring planned staged bone grafting.
* Vascular injury.

Primary outcomes:
measure: Number of study-eligible subjects
timeFrame: Baseline
Secondary outcomes:
measure: Operative times
timeFrame: Duration of surgery, approximately 2-4 hours
measure: Blood loss
timeFrame: Duration of surgery, approximately 2-4 hours
measure: Hospitalization days
timeFrame: approximately 2-3 days
measure: Early post-surgical complications
timeFrame: 2 weeks post-surgery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Brandon Yuan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06238999: Split-mouth Study of a New Flowable Composite in Non-carious Cervical Lesions
Official title: Clinical Evaluation of a New Flowable Composite for Direct Restorative Treatment of Non-carious Cervical Lesions: A Prospective Randomized Split-mouth Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-carious Cervical Lesions
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
First posted: 2024-02-02
Enrollment: 66
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: Split-Mouth Design
Primary purpose: TREATMENT

Brief summary: The overall objective of this clinical investigation is to evaluate the clinical safety and performance of the new flowable composite TM Flow for treatment of non-carious cervical lesions. Each participant receives two different fillings (test- and control material) in two different teeth. The fillings are assessed according to selected FDI criteria at baseline (7-10 days after filling placement) and after 1, 6, 12, 24, 36 and 60 months.


Eligibility criteria: Inclusion Criteria:

* Informed Consent signed by the subject
* Age: 18-65 years
* 2 NCCL needing treatment, comparable in extend and size, preferably located in different quadrants
* Vital teeth, regular sensitivity
* Sufficient language skills
* No active periodontitis
* Preoperative VAS values \< 3 regarding tooth sensitivity on biting. Tooth sensitivity on temperature or touching (tooth brushing, probing) originating in the area of the NCCL is accepted.
* Subject wishes to have a restoration as part of the study (written declaration of consent after detailed explanation)

Exclusion Criteria:

* Not completed hygiene phase or poor oral hygiene
* Sufficient isolation of the cavity not possible
* Patients with a proven allergy to one of the ingredients (methacrylates)
* Patients with severe systemic diseases
* Periodontally insufficient dentition
* Pregnancy
* Part of the development project team of TM Flow
* Staff of the study management team
* Staff of the internal clinic

Primary outcomes:
measure: Postoperative Hypersensitivity
timeFrame: 1 month
Secondary outcomes:
measure: Evaluation of Functional (e.g. Fracture of the Material and Retention), Biological (e.g. Caries at Restoration Margins) and Aesthetic (e.g. Color Match) Properties of the Restorations
timeFrame: 5 years
Other outcomes:
Locations:
city: Schaan
country: Liechtenstein
facility: Ivoclar Vivadent AG
Study officials:
References:
Clinical trial NCT03744299: The Interest of Cancer Patients and Caregivers in Acupuncture: a Survey
Official title: The Interest of Cancer Patients and Caregivers in Acupuncture: a Survey
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: acupuncture
surveys and questionnaires
patient
caregiver
Lead sponsor: General Hospital Groeninge
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Cancer and cancer treatments are accompanied by several possible side effects, such as nausea, hot flashes, fatigue, drowsiness, etc. Complementary and integrative therapies, such as acupuncture, could be used to manage these symptoms. The aim of this study for our research team is to have an idea of the interest of cancer patients and caregivers in acupuncture. This is a prospective, interventional study. Cancer patients and caregivers will be approached at the day care clinic by a health care worker to participate in this study. They will be asked to complete a questionnaire about their interest in acupuncture and their motivation, what symptoms they would need it for, where they would like this acupuncture to take place, whether they are willing to pay for it, and whether they would be interested in an information session about acupuncture.


Eligibility criteria: Inclusion Criteria:

* Dutch speaking patients and caregivers
* Patients and caregivers presenting at the outpatient clinic, including the day-care clinic and follow up visits

Primary outcomes:
measure: Response rate
timeFrame: At study inclusion
Secondary outcomes:
measure: Interest in acupuncture assessed by questionnaire
timeFrame: At study inclusion
measure: Side effects participants would like to receive acupuncture for assessed by questionnaire
timeFrame: At study inclusion
measure: Place where an acupuncture treatment should take place assessed by questionnaire
timeFrame: At study inclusion
measure: Willingness to pay for an acupuncture treatment assessed by questionnaire
timeFrame: At study inclusion
measure: Interest in an information session about acupuncture assessed by questionnaire
timeFrame: At study inclusion
measure: Patient or caregiver characteristics (sex, age, diagnosis) collected by questionnaire
timeFrame: At study inclusion
Other outcomes:
Locations:
city: Kortrijk
country: Belgium
facility: General Hospital Groeninge, Cancer Center
Study officials:
affiliation: General Hospital Groeninge
name: Philip Debruyne, MD, PhD, MSc, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03343899: Genotype-related Molecular Targets in the Vitamin D Pathway for Spinal Disc Diseases
Official title: Identification of Genotype-related Molecular Targets in the Vitamin D Pathway for Personalized Pharmacological Treatments of the Spinal Disc Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intervertebral Disk Degeneration
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 15
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 spinal disc diseases

Brief summary: The objective of our study will be to analyze the interplay between particular VDR variants and its ligand in cells obtained from intervertebral disc and cartilage endplate and their action on cell proliferation and phenotype maintenance. The identification of novel molecular targets in the vitamin D pathway, potentially promoting pathological alterations of the tissues involved in spinal disc diseases, will allow to develop innovative and more personalized preventive and pharmacological/nutritional therapies.


Eligibility criteria: Inclusion Criteria:

patients with spinal disc diseases

* males and females
* 18≤age ≤ 70 years old
* Italian white
* patients with spinal disc diseases that will be surgically treated

Exclusion criteria:

- age \< 18 or \> 70 years old

Primary outcomes:
measure: Phenotype and genotype characterization
timeFrame: 1 year
Secondary outcomes:
measure: Disc cell functional response genotype-based
timeFrame: 2 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Alessandra Colombini
Study officials:
References:
Clinical trial NCT04460599: Neurological Features During COVID19
Official title: Description of neurolOgical Involvement Observed During SARS COV2 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Encephalitis
Keywords: Cranial nerves
brainstem
dysautonomia
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population hospitalized in ICU for COVID 19.

Brief summary: Description of the neurological impairment: clinico-radiological and electrophysilogical correlations

Detailed description: Describe short and long term clinical radiological and electrophysilogical presentations of neurological damage central and peripheral SARS COV2 infection Describe the association between neurological, respiratory and dysautonomic Determine the prognosis of neurological damages to short and long term.

Eligibility criteria: Inclusion Criteria:

* PCR SARS COV2 positive or CT Scan
* Central neurological signs such as confusion, epilepsy, abnormal movement, pyramidal signs, motor or sensory deficit, involvement of cranial pairs (such as anomie or ageusia) or peripheral.
* Dysautonomic signs such as hypotension or hypertension, bradycardia or tachycardia, hypothermia, SIADH not explained by therapy or a pathology other than SARS COV 2 infection

Exclusion Criteria:

* Contraindication to performing an MRI scan
* Minor
* Pregnant woman
* No follow-up possible at 6 months

Primary outcomes:
measure: Primary
timeFrame: 6 months
Secondary outcomes:
measure: Secondary
timeFrame: 6 months
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
Study officials:
References:
Clinical trial NCT01295099: Keloid Scarring: Treatment and Pathophysiology
Official title: Keloid Scarring:A Randomized Clinical and Laboratory Based Study on the Treatment and Differentiation Factors of the Local Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Keloid Scar
Keywords: scar formation
5-FU
genetic link
psychological impact
social impact
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2011-02-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To clarify the mechanisms of Keloid scar formation.

Elucidate the action and therapeutic value of 5-FU in Keloid scar treatment

Identify the genetic link with Keloid scar formation.

Quantify the psychological/social impact in keloid scarring patients


Eligibility criteria: Inclusion Criteria:

* Adult ( \> 18 years old).
* Keloid scarring present.
* Able to understand and give informed consent.
* Patients giving informed consent to donate keloidal or non-affected skin when that is redundant after a procedure (i.e. BBR, Abdominoplasty).
* Patients with a strong familial pedigree of keloid scar formation.

Exclusion Criteria:

* Open wound at or proximity of the lesion

  * Infected lesion
  * Pregnant or planning pregnancy in the near future
  * Lactating (Breast Feeding)
  * Abnormal renal or liver function tests
  * Atrophic scars
  * Patient under 18 years of age
  * Immunocompromised
  * OR immunosuppressed

Primary outcomes:
measure: Keloid Scar Reduction
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts and the London NHS Trust
state: UK
Study officials:
References:
Clinical trial NCT05978999: Blood Pressure Monitor Clinical Test (Cuff Range: 15cm-24cm, 20cm-34cm, 30cm-44cm, 22cm-42cm)
Official title: Blood Pressure Monitor#Model#BPM1#Clinical Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Lead sponsor: Andon Health Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-08-07
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal blood pressure and hypertensive patients over 12 years old

Brief summary: The purpose of this study is to verify the accuracy of the 4 blood pressure cuffs with blood pressure monitor device.

Cuff circumference is : 15cm-24cm, 20cm-34cm, 30cm-44cm, 22cm-42cm


Eligibility criteria: Inclusion Criteria:

* Normal blood pressure and hypertensive patients over 12 years old

Exclusion Criteria:

* Patients with serious arrhythmias or a high frequency of arrhythmias
* Pregnant woman
* Other investigators believe that it is not suitable to participate in this clinical trial

Primary outcomes:
measure: blood pressure monitor accuracy
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Study officials:
References:
Clinical trial NCT06714799: Analysis of Videodermatoscopic Parameters of Ocular, Periocular, Conjunctival and Palpebral Neoformations
Official title: Analysis of Videodermatoscopic Parameters of Ocular, Periocular, Conjunctival and Palpebral Neoformations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ocular Surface Disease
Keywords: videodermatoscopia
occhi
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients presented to the Videodermatoscopy Outpatient Clinic of the O.U. Dermatology of the S. Orsola-Malpighi General Hospital

Brief summary: ANALYSIS OF VIDEODERMATOSCOPIC PARAMETERS OF OCULAR, PERIOCULAR, CONJUNCTIVAL AND PALPEBRAL NEOFORMATIONS

Detailed description: The analysis of videodermatoscopic parameters of ocular, periocular, conjunctival and eyelid neoformations refers to the use of advanced technology that allows us to examine in detail the lesions or neoformations that appear in and around the eye areas. Through videodermatoscopy, we can evaluate characteristics such as size, shape, color and internal structure of these neoformations, to distinguish benign ones from those that may require further diagnostic investigations or treatments.

Eligibility criteria: Inclusion Criteria:

* patients who had been diagnosed with one of the following conditions in the ocular and periocular region: common melanocytic nevus, melanosis, seborrheic keratosis, viral wart, angioma and angiokeratoma, apocrine hydrocystoma, xanthelasma, steatocystoma, actinic keratosis, basal cell carcinoma, squamous cell carcinoma, melanoma.

Exclusion Criteria:

* Patients who presented with one of the following conditions were excluded from the study: concomitant inflammatory processes, including blepharitis, chalazion, pterygium, pinguecula), coexistence of multiple, periocular or ocular lesions, diagnosis of syndromic diseases related to a major risk for cutaneous neoformations.

Primary outcomes:
measure: features that could indicate their benign or malignant nature
timeFrame: from enrollment to the end of 2026
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Sabina Vaccari, MD
role: PRINCIPAL_INVESTIGATOR
References: