louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06604299: Digital Mindfulness Meditation-enhanced Cognitive Behavioral Therapy (CBT-MM) for Binge Eating Disorder
Official title: Digital Mindfulness Meditation-enhanced Cognitive Behavioral Therapy (CBT-MM) for Binge Eating Disorder User-Testing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Binge Eating Disorder
Keywords: binge eating
eating disorders
obesity
Lead sponsor: Yeshiva University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-09-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators will evaluate the acceptability and feasibility of a 18-week long digital mindfulness-based and cognitive behavioral therapy intervention for binge eating disorder.

This study is a prospective single-arm trial during the intervention development phase. Following this phase, after the intervention has been further developed, a subsequent study (with a different clinicaltrials.gov identification #) will utilize a randomized control trial design.

Detailed description: Procedures include completing: (1) pre-intervention screening assessment; (2) an initial baseline visit; (3) 18-week web-based intervention; and (4) a post-intervention assessment (18-weeks after baseline).

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Meeting DSM-5 criteria for Binge Eating Disorder (BED)
* English-speaking

Exclusion Criteria:

* BMI \&lt; 18.5
* Requiring immediate treatment for medical complications
* Current anorexia or bulimia nervosa or purging behaviors within the past year
* Already receiving treatment for an ED or participating in a weight loss program or psychotherapy focused on weight (psychotherapy for other conditions was allowed)
* Currently pregnant or breast-feeding
* Experiencing other severe psychopathology or medical illness that would limit the participants' ability to comply with the demands of the current study (e.g. active psychotic disorder, cancer)

Primary outcomes:
measure: Acceptability
timeFrame: 18-week treatment period
measure: Feasibility/Completion
timeFrame: 18-week treatment period
Secondary outcomes:
measure: Changes in Emotion Dysregulation
timeFrame: Baseline to post-treatment (18-weeks)
measure: Changes in Mindfulness
timeFrame: Baseline to post-treatment (18-weeks)
measure: Changes in Objective Binge Eating Episodes
timeFrame: Baseline to post-treatment (18-weeks)
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline to post-treatment (18-weeks)
measure: Changes in Dietary Restraint
timeFrame: Baseline to post-treatment (18-weeks)
measure: Changes in Quality of Life
timeFrame: Baseline to post-treatment (18-weeks)
measure: Changes in Depression Symptoms
timeFrame: Baseline to post-treatment (18-weeks)
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Yeshiva University
state: New York
Study officials:
References:
Clinical trial NCT06033599: Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement
Official title: Motivational Interviewing (MI) and Mindfulness-Oriented Recovery Enhancement (MORE) for Tobacco Dependence and Other Drug Use in Methadone Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Polysubstance Abuse
Opioid Use
Tobacco Use
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: University of Utah
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-09-13
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to 1) examine barriers and facilitators to implementation of MI and MORE for polysubstance use and evaluate strategies for optimizing training, fidelity, and clinic uptake, and 2) evaluate patient outcomes related to the effectiveness of MORE decreasing opioid, tobacco, and other drug use.


Eligibility criteria: Inclusion Criteria:

* English-speaking
* Age ≥18
* Currently on methadone; and 4) currently smoke cigarettes.

Exclusion Criteria:

* Severe cognitive impairment (score \>23 on Mini Mental Status Exam) or psychosis (positive SCID Psychotic Screen)
* Suicidal risk (score ≥7 on Suicidal Behaviors Questionnaire)
* Inability to attend or fully participate in intervention sessions or assessments
* Previous formal mindfulness training (e.g., MBSR, MBRP) or MORE (from the R21 or R33
* Currently taking smoking cessation pharmacotherapy or participating in smoking cessation counseling
* Any contraindications for NRT
* Currently or soon planning to be pregnant or breastfeeding.

Primary outcomes:
measure: Days of Drug Use
timeFrame: Baseline through 52 weeks.
measure: Days of Tobacco Use
timeFrame: Baseline through 52 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Nina Cooperman, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05182099: High Resolution HBA-MRI Using Deep Learning Reconstruction
Official title: AIRTM Deep Learning Reconstruction of Abdominal High Resolution Gd-EOB-DTPA Enhanced MRI in Patients With Suspicious Focal Liver Lesions: Image Quality Assessment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Diseases
Magnetic Resonance Imaging
Deep Learning
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2022-01-10
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to compare image qualities between conventionally reconstructed MRI sequences and deep-learning reconstructed MRI sequences from the same data in patients who undergo Gd-EOB-DTPA enhanced liver MRI. The AIRTM deep learning sequence is applicable for various MRI sequences including T2-weighted image (T2WI), T1-weighted image and diffusion-weighted image (DWI). We plan to perform intra-individual comparisons of the image qualities between two reconstructed image datasets.


Eligibility criteria: Inclusion Criteria:

* older than 20 years old
* scheduled for Gd-EOB-DTPA enhanced liver MRI at a 3T scanner (Premier, GE Healthcare) in our institution
* signed informed consent

Exclusion Criteria:

* younger than 20 years old
* any absolute/relative contrast indication of Gd-EOB-DTPA enhanced MRI
* history of transient dyspnea after Gd-EOB-DTPA administration

Primary outcomes:
measure: Overall image quality of arterial phase
timeFrame: 3 months after enrollment completion
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01155999: Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Purulent Bacterial Conjunctivitis
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2010-07-02
Enrollment: 286
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.


Eligibility criteria: Inclusion Criteria:

* Age ≥ one day of life and ≤ 18 years
* Purulent bacterial conjunctivitis

Primary outcomes:
measure: The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3
timeFrame: Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
Study officials:
References:
Clinical trial NCT05905042: Follow-up of Recovery Condition in Survivors of Acute Respiratory Distress Syndrome
Official title: Follow-up of Recovery Condition in Survivors of Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mortality
Lead sponsor: Chimei Medical Center
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ARDS patients

Brief summary: Hope to realize the recovery condition of ARDS survivors in Taiwan. It would be helpful not only to design the proper rehabilitation program but also to be a useful reference for the poor recovery patients to take hospice care if indicated.

Detailed description: This study will enroll the participant met the diagnostic criteria of ARDS. The basic data, clinical manifestations, laboratory data and outcomes of participants will be recorded.

And the investigator will also follow up the pulse oximeter, peak expiratory flow rate, six-minute walk test and health-related quality of life measures with SF-36 in 3, 6 and 12 months after the participants were discharged from the ICU. Through this study, the investigator hope to realize the recovery condition of ARDS survivors in Taiwan.

It would be helpful not only to design the proper rehabilitation program but also to be a useful reference for the poor recovery patients to take hospice care if indicated.

Eligibility criteria: Inclusion Criteria:

* ARDS patients

Exclusion Criteria:

* NA

Primary outcomes:
measure: occurrence of postextubation stridor
timeFrame: 24 hours
Secondary outcomes:
measure: The actual tidal volume at expiration
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02565342: Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery
Official title: Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain
Keywords: Clavicle
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The sensory innervation of the clavicle remains an area of debate. Regional nerve blocks aimed at relieving pre- and post-operative pain include the superficial cervical plexus blocks, interscalene blocks and a combined version of the above. In this case study, the investigators aim to describe the protocol used in a university hospital: general anaesthesia with interscalene brachial plexus block, followed by optional iv morphine administration in phase 1 recovery and oral oxycodone on the ward.


Eligibility criteria: Inclusion Criteria:

* clavicular fracture with internal reduction
* physical status I - III

Exclusion Criteria:

* contraindication to regional anaesthesia
* history of neck radiotherapy
* patient suffering from chronic pain
* severe respiratory disease

Primary outcomes:
measure: IV Morphine consumption in phase 1 recovery (mg)
timeFrame: 0-2 hours after surgery
Secondary outcomes:
measure: Pain scores at rest and on movement (numeric rating scale, 0-10)
timeFrame: Postoperative day 0 and 1
measure: Postoperative nausea and vomiting (yes/no)
timeFrame: Postoperative day 0 and 1
measure: Itching (yes/no)
timeFrame: Postoperative day 0 and 1
measure: Cumulative oxycodone consumption (mg)
timeFrame: up to postoperative day 1
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
state: Vaud
Study officials:
References:
citation: Olofsson M, Taffe P, Kirkham KR, Vauclair F, Morin B, Albrecht E. Interscalene brachial plexus block for surgical repair of clavicle fracture: a matched case-controlled study. BMC Anesthesiol. 2020 Apr 20;20(1):91. doi: 10.1186/s12871-020-01005-x.
Clinical trial NCT01296542: A Comparison of Prophylactic Antibacterial Efficacy of Besivance vs. VIGAMOX Prior to Cataract Surgery
Official title: A Comparison of Prophylactic Antibacterial Efficacy of Besivance Versus VIGAMOX Administered for Three Days and One Hour Prior to Phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataracts
Lead sponsor: Bucci Laser Vision Institute
Sponsor class: OTHER
First posted: 2011-02-15
Enrollment: 60
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: To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3 days of treatment.


Eligibility criteria: Inclusion Criteria:

* Man or woman 18 years of age or older.
* Physically capable of instilling eye drop or have an appropriate person available to assist in administration of eye drops 4 times a day.
* Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the treatment of cataract.
* Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be medically cleared for surgery.
* Willing to adhere to the prohibitions and restrictions specified in this protocol.
* Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

* Known allergy or contraindication to the test article(s) or their components.
* Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters.
* Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
* History of any significant illness that could be expected to interfere with the study parameters. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.
* Use of disallowed therapies (systemic or topical):

  * Fluoroquinolone anti-infective agents (systemic or topical) within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study.
* Use of contact lenses for one week prior to the study and for the duration of the study.
* Received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment.

Primary outcomes:
measure: Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days
timeFrame: Following 3 days of antibiotic drops topically instilled
Secondary outcomes:
Other outcomes:
Locations:
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision Institute
state: Pennsylvania
Study officials:
affiliation: Bucci Laser Vision Institute
name: Frank A. Bucci, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05426642: The Effect of E-health Video Towards Enhancing Cervical Cancer Screening
Official title: Development and Evaluation of KaSEH Video to Increase Women's Knowledge and Motivation Regarding Cervical Cancer and Its Screening.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer Screening
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of this quasi-experimental study is to evaluate the women's motivation related to cervical cancer screening. The experiment group will receive the e-health video KaSEH and brochure as the intervention. Where as, the control group will receive brochure as the intervention. There is three phase of evaluation which are pre-intervention, intra-intervention and post-intervention. The evaluation will be assess using the self-administered questionnaire based on Protection Motivation Theory. The estimated duration of this quasi-experiment is six month.


Eligibility criteria: Inclusion Criteria:

* Women who have never undergone cervical cancer screening.

Exclusion Criteria:

* Women who have been diagnosed or are cervical cancer patients
* Women who have been diagnosed with any cancer of the gynecological system such as cancer of the vulva, vagina, uterus, fallopian tubes and ovaries.

Primary outcomes:
measure: Motivation level
timeFrame: 3 month
measure: Practice
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02596542: Cold Water Immersion and Recovery
Official title: Cold Water Immersion as a Strategy to Promote Post-exercise Recovery in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-exercise Cold Water Immersion
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cold-water immersion (CWI) is a frequently applied strategy to accelerate post-exercise recovery in both recreational as well as professional athletes. However, the effect of repeated post-exercise CWI on other recovery strategies remains unclear.


Eligibility criteria: Inclusion Criteria:

* Males
* Aged between 18-35 years
* Healthy, recreationally active
* BMI \< 25 kg/m2
* The ability to comply with the protocol (i.e. the set-up for the CWI is designed for subjects that are at least 1.70 m or taller).

Exclusion Criteria:

* Smoking
* Allergies to milk proteins (whey or casein)
* Female
* Arthritic conditions
* A history of neuromuscular problems
* Recent (\<1 y) participation in amino acid tracer studies
* Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
* Individuals with GI diseases

Primary outcomes:
measure: Muscle protein synthesis (expressed as fractional synthetic rate (FSR in %/h)
timeFrame: 2 weeks
Secondary outcomes:
measure: Muscle temperature (expressed as degrees celsius)
timeFrame: 1 day
measure: Glycogen concentration (expressed as micromol glycosol units*g dry wt)
timeFrame: 1 day
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References:
citation: Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.
Clinical trial NCT01499342: Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent in the Superficial Femoral Artery
Official title: Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent to Treat Atherosclerotic Lesions in the Superficial Femoral Artery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Keywords: Stent
Atherosclerotic occlusive disease
Peripheral arterial disease
Superficial femoral artery
SFA
Lead sponsor: be Medical
Sponsor class: INDUSTRY
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
name: Ziekenhuis Oost-Limburg
First posted: 2011-12-26
Enrollment: 435
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: Stenosis (\> 75%) or occlusion of the superficial femoral artery.

Brief summary: This is a Belgian prospective multicentre registry to evaluate safety and performance of the Sinus-Superflex-Visual stent (Optimed) in Superficial Femoral Artery (SFA) atherosclerotic lesions. Target number is 500 patients in approximately 11 centres. Patients will be followed for a period of 2 years.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Stenosis (\> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to Hunter's canal and 4 cm proximal to the patella)
* TASC II (2007)type A, B or C lesions
* Target vessel diameter between 4.5 and 7 mm
* Debilitating claudication or critical limb ischemia (Rutherford 2 to 5)
* At least 1 outflow vessel down to the ankle
* Patient is at least 18 years old
* Life expectancy \> 2 years
* Patient is compliant with the requested follow-up visits

Exclusion Criteria:

* No informed consent
* Rutherford 6
* TASC II type D lesions
* Patient is not 18 years old
* Patient is pregnant
* Acute ischemia
* Patient is not compliant with the requested follow-up visits
* Unable to cross target lesion with guidewire
* Patient is allergic to nickel-titanium
* Presence of an aneurysm in the SFA

Primary outcomes:
measure: Primary patency
timeFrame: 12, 24 months
Secondary outcomes:
measure: Secondary patency
timeFrame: 12 and 24 months
measure: Target lesion revascularization
timeFrame: 12 and 24 months
measure: Target vessel revascularization
timeFrame: 12 and 24 months
measure: Limb-salvage rate
timeFrame: 12 and 24 months
measure: Clinical success rate
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
state: Limburg
city: Leuven
country: Belgium
facility: University Hospital Leuven
state: Vlaams Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Sabrina Houthoofd, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ziekenhuis Oost-Limburg
name: Herman Schroë, MD
role: PRINCIPAL_INVESTIGATOR
References: