louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06097572: Improved Diagnostics in Food Allergy Study
Official title: Improved Diagnostics in Food Allergy (ID-in-FA) Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Food Allergy
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Royal College of Surgeons, Ireland
name: University of Manchester
First posted: 2023-10-24
Enrollment: 166
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators will conduct low-dose intranasal allergen challenges on children and young people with an indeterminate diagnosis of food allergy to cow's milk or peanut. Blood samples will also be taken, for conventional blood allergy diagnostics (allergy-specific Immunoglobulin E) and mast cell activation test (MAT). The data will be used to determine the diagnostic accuracy of two complementary, novel approaches to diagnose food allergy, in a representative clinical cohort.


Eligibility criteria: Inclusion Criteria:

* IgE-sensitisation to peanut, (hen's) egg or cow's milk, with indeterminate clinical (allergy) status, defined as IgE-sensitisation below 95% positive predictive value (PPV) for diagnosis for either allergen-specific IgE or SPT, using published cut-offs OR clinician suspicion of tolerance (on basis of clinical history) despite IgE sensitisation \>95% PPV cut-offs.
* Written informed consent from parent/guardian, with assent from children aged 6 years and above wherever possible. Participants aged over 16 years will need to provide their own informed consent.

Exclusion Criteria:

* Acute illness or current unstable asthma, defined as:

  1. Febrile ≥38.0oC in last 72 hours
  2. Acute wheeze in last 72 hours requiring treatment
  3. Recent admission to hospital in preceding 2 weeks for acute asthma
* Current medication

  1. Asthma reliever medication required in preceding 72 hours
  2. Recent administration of a medicine containing antihistamine within the last 3 days
  3. Current oral steroid for asthma exacerbation or course completed within last 2 weeks
* Unwilling or unable to fulfil study requirements

Primary outcomes:
measure: Test performance
timeFrame: 1 day
Secondary outcomes:
measure: Adverse events
timeFrame: 1 day
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Prof Jonathan Hourihane
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust (St. Mary's Hospital)
Study officials:
References:
Clinical trial NCT01318772: Clinical Image Evaluation for the DREX-KL80 Imaging System
Official title: Clinical Image Evaluation for the KALARE (DREX-KL80) With New Digital Camera and Image Processor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation.
Lead sponsor: Toshiba America Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patient 18 years and older

Brief summary: The purpose of this study is to acquire the clinical data required by the United States Food and Drug Administration (USFDA) for 510(k) submission, for approval of a new high resolution imaging system for fluoroscopy/radiography. It is expected that the new KALARE (DREX-KL80)high resolution imaging system will meet the design specifications. A minimum of 30 cases will be submitted for evaluation of claims for intended clinical applications.


Eligibility criteria: Inclusion Criteria:

* Male and female patient 18 years and older
* Not pregnant
* Not a safety risk patient

Exclusion Criteria:

* Male and female patient under 18 years old
* Pregnant subjects
* High safety risk subjects
* Subjects and/or Legal Guardian Unable to provide informed consent

Primary outcomes:
measure: Collection of representative images
timeFrame: Estimated completion 4 weeks after start of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: SDMI
state: Nevada
Study officials:
affiliation: Stienberg Diagnostic Meidcal Imaging (SDMI)
name: Mark Winkler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00406172: Intravitreal Bevacizumab (Avastin) for Pseudophakic Macular Edema (PME)
Official title: Intravitreal Bevacizumab (Avastin) for Pseudophakic Macular Edema (PME)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Cystoid Macular Edema
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2006-12-04
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To report safety and efficacy of intravitreal injection of bevacizumab in patients with cystoid macular edema secondary to cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Pseudophakic eyes with macular edema

Exclusion Criteria:

* Other retinopathies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: México D.F.
country: Mexico
facility: APEC
Study officials:
affiliation: APEC México
name: Victoria Cubas-Lorenzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03601572: Hypnoanalgesia in Surgical and Endovenous Treatment of Varicosis
Official title: Hypnoanalgesia in Surgical and Endovenous Treatment of Varicosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Varicose Veins
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients treated under local anesthesia by Laser or radiofrequency or phlebectomies for their varicose veins

Brief summary: Endoveinous treatment of saphenous varicoses and phlebectomia of tributary veins are commonly performed under local anesthesia. Hypnoanalgesia might reduce perinterventional pain.

This study has the aim to test the effectiveness of hypnoanalgesia, performed by a specialised nurse, for peri-and post-procedual pain reduction.


Eligibility criteria: Inclusion Criteria:

* patients treated under local anesthesia by Laser or radiofrequency or phlebectomies for their varicose veins
* Age of 18 and over

Exclusion Criteria:

* NA

Primary outcomes:
measure: Evaluate the effects of hypnosis
timeFrame: on intraoperative
measure: Evaluate the effects of hypnosis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Montpellier
name: GUDRUN BOGE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02139072: CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients
Official title: Accuracy of CoaguChek XS in Patients With Antiphospholipid Antibody Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antiphospholipid Antibody Syndrome
Keywords: Anticoagulation
International normalized ratio
Warfarin
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2014-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to UF/Shands Hematology Anticoagulation Clinic for a routine office visit with pharmacy.

Brief summary: The purpose of this study is to see if the CoaguChek XS is accurate in measuring International Normalized Ratio (INR) in patients with Antiphospholipid Antibody Syndrome (APL) receiving warfarin therapy.

Detailed description: Antiphospholipid Antibody Syndrome (APL) is an autoimmune disease that increases ones risk for blood clots. Therefore, these patients receive anticoagulation therapy with warfarin. Point of care devices such as the CoaguChek XS are often used to monitor International Normalized Ratio (INR) in patients on warfarin. However, the antibodies present in patients with APL may lead to false INR results when using the CoaguChek XS. This study will compare the accuracy of the CoaguChek XS in measuring INR in patients with APL by measuring INR by the CoaguChek XS and a standard lab as a reference point. Patients on warfarin for indications other than APL will be measured by both methods as well to serve as a control group.

Eligibility criteria: Inclusion Criteria:

* 18-65 years of age
* anticoagulated with warfarin for at least 1 month
* Diagnosis of antiphospholipid antibody syndrome for intervention arm

Exclusion Criteria:

* any type of mental disability that would hinder their ability to give informed consent
* any terminal illness or any other condition that could interfere with study completion, that person will be excluded.

Primary outcomes:
measure: International Normalized Ratio (INR)
timeFrame: Day 1 and Day 60
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF and Shands Health
state: Florida
Study officials:
affiliation: University of Florida
name: James Taylor, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00935272: Safety/Efficacy Study of Restylane® in Lip Augmentation
Official title: A Randomized, Evaluator-Blinded, No-Treatment-Controlled Study of the Effectiveness and Safety of Restylane® in the Augmentation of Soft Tissue Fullness of the Lips
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lip Augmentation
Lead sponsor: Medicis Global Service Corporation
Sponsor class: INDUSTRY
First posted: 2009-07-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the safety and effectiveness of Restylane® when used for lip augmentation.


Eligibility criteria: Inclusion Criteria:

* Must meet established lip fullness criteria

Exclusion Criteria:

* Allergic to injectable hyaluronic acid, local topical anesthetics or nerve blocking agents; Conditions/procedures that could interfere with lip fullness evaluations

Primary outcomes:
measure: Percentage of Participants With Response
timeFrame: Baseline and at 8 weeks
Secondary outcomes:
measure: Percentage of Participants With a Response
timeFrame: Baseline and at weeks 12, 16, 20 and 24
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Call for Information
state: California
city: San Francisco
country: United States
facility: Call for Information
state: California
city: Santa Monica
country: United States
facility: Call for Information
state: California
city: New Haven
country: United States
facility: Call for Information
state: Connecticut
city: Coral Gables
country: United States
facility: Call for Information
state: Florida
city: Miami Beach
country: United States
facility: Call for Information
state: Florida
city: Hunt valley
country: United States
facility: Call for Information
state: Maryland
city: Chestnut Hill
country: United States
facility: Call for Information
state: Massachusetts
city: Clinton Twp.
country: United States
state: Michigan
city: Warren
country: United States
facility: Call for Information
state: Michigan
city: Mount Kisco
country: United States
facility: Call for Information
state: New York
city: Chapel Hill
country: United States
facility: Call for Information
state: North Carolina
Study officials:
affiliation: Medicis Global Service Corporation
name: Heather Corey, MBA
role: STUDY_CHAIR
References:
Clinical trial NCT06283472: Enhancing Prospective Thinking in Early Recovery (BEAM)
Official title: Enhancing Prospective Thinking in Early Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Alcohol Use Disorder
Alcohol Abuse
Heavy Drinking
Alcohol
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to test the prosocial effects of personally-relevant, high-intensity episodic future-thinking (EFT) cues in alcohol use disorder persons and related brain mechanisms. The main question\[s\] this trial aims to answer are:

* Will high-intensity EFT cues will produce greater delayed reward preference than low-intensity cues?
* Will high-intensity EFT cues effect greater treatment-seeking interest?
* Will high-intensity EFT cues elicit greater response in regions for prospective thinking during delay discounting (vs. low-intensity)
* Will nucleus accumbens-precuneus resting connectivity correlate with behavioral SS?
* Will the novel behavioral SS decision-making task activate the nucleus accumbens?

Researchers will compare the experimental (high-intensity group) and control (low-intensity) groups to see if there are differences in the results for the questions outlined above.


Eligibility criteria: Inclusion Criteria:

* Individuals who meet current heavy drinking (≥2 heavy drinking days/month OR ≥7 drinks/week for biological females, and ≥14 drinks/week if biological male \[NIAAA definition\] and/or AUDIT scores ≥8)
* English comprehension

Exclusion Criteria:

* Unstable medical disorders
* Outside the age range of 18-60
* Smell/taste disorders
* Unstable psychiatric conditions

Primary outcomes:
measure: Increase Prospective Thinking
timeFrame: Study Day Visit (Day 1)
measure: Delayed Rewards
timeFrame: Study Day Visit (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine - Goodman Hall
state: Indiana
Study officials:
References:
Clinical trial NCT06971172: Low-level Laser Therapy on Oral Pemphigus Vulgaris Patients.
Official title: EFFECT OF LOW LEVEL LASER THERAPY ON ORAL PIMPHIGUS VULGARIS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pemphigus Vulgaris
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the therapeutic efficacy of low level laser therapy on oral pemphigus vulgaris patients.


Eligibility criteria: Inclusion Criteria:

* Patients with oral pemphigus vulgaris

Exclusion Criteria:

* other causes of oral ulcers

Primary outcomes:
measure: wound margins in millimeters
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01534572: Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa
Official title: Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2012-02-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: There is a constant exchange between the gut epithelium and lumen, including microbial interplay. The aim of this study was to investigate dietary test products on inflammatory proliferation markers in the gut, and thereby if the products had positive effects in the gut as well as in other parts of the body.

The hypothesis was that the test products would reduce the inflammatory and proliferation activity of the gut epithelium by fermentation of normal food products and by converting dietary phenolic compounds into anti-inflammatory substances.


Eligibility criteria: Inclusion Criteria:

* 18-80 years old,
* Able to understand oral and written information,
* Informed consent

Exclusion Criteria:

* Ongoing immune suppressive treatment, incl. cortisone,
* Ongoing antibiotic treatment or antibiotic treatment ended within 4 weeks,
* History of inflammatory bowel disease

Primary outcomes:
measure: Reactivity of rectal mucosa
timeFrame: after 2 weeks intervention
Secondary outcomes:
measure: influence on immune system
timeFrame: after 2 weeks intervention
Other outcomes:
Locations:
Study officials:
affiliation: Region Skåne
name: Bengt Jeppson, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Stene C, Rome A, Palmquist I, Linninge C, Molin G, Ahrne S, Johnson LB, Jeppsson B. Administration of probiotics to healthy volunteers: effects on reactivity of intestinal mucosa and systemic leukocytes. BMC Gastroenterol. 2022 Mar 5;22(1):100. doi: 10.1186/s12876-022-02185-1.
Clinical trial NCT02041572: Attentional Bias Retraining in Veterans
Official title: Attentional Bias Retraining in Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Lead sponsor: VA Pacific Islands Health Care System
Sponsor class: FED
First posted: 2014-01-22
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study has two goals. First to develop a computer-based intervention meant to alter cognitive biases that contribute to ongoing PTSD symptoms. Second, we sought to pilot test the intervention in a small sample of veterans for feasibility and acceptability.

Detailed description: Aim 1: Develop Attentional Bias Retraining protocol (Phase 1)

* 1.1 Computerized assessment \& retraining programs
* 1.2 Procedures and measures

Aim 2: Implement in pilot sample (Phase 2)

* 2.1: Assess feasibility and tolerability
* 2.2: Collect pilot data to plan future studies
* 2.3: Efficacy estimates based on changes in response time to dot probe task

Eligibility criteria: Inclusion Criteria:

* Participated in ground combat operations in Vietnam
* Scored 40 - 80 on PTSD Checklist - Military version
* Availability and willingness to attend 2x weekly computer sessions for 6 weeks

Exclusion Criteria:

* Active substance dependence
* Significant cognitive impairment
* Current and active suicidal or homicidal ideation

Primary outcomes:
measure: Post-traumatic Checklist - Military version (PCL-M)
timeFrame: Change from Baseline and Post-treatment (1 month after last training session)
Secondary outcomes:
measure: Attentional bias scores
timeFrame: Change from Baseline and Post-treatment (1 month after last training session)
Other outcomes:
measure: Daily of PTSD symptoms, specifically hyperarousal and intrusive symptoms (nightmares, reenactments, and triggered and untriggered recall)
timeFrame: Change from Baseline and Post-treatment (1 month after last training session)
Locations:
city: Honolulu
country: United States
facility: National Center for PTSD
state: Hawaii
Study officials:
affiliation: National Center for PTSD/PHREI
name: Margaret-Anne Mackintosh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00862472: Safety and Efficacy Study of DuoTrav APS Versus DuoTrav
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Open-angle Glaucoma
Ocular Hypertension
Keywords: open-angle glaucoma
ocular hypertension
open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-03-17
Enrollment: 0
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 the study is to demonstrate that the IOP-lowering efficacy of DuoTrav APS, dosed once-daily in the morning, is non-inferior to that of DuoTrav, dosed once-daily in the morning.


Eligibility criteria: Inclusion Criteria:

* Patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator and who are currently on a stable treatment of IOP-lowering medication

Exclusion Criteria:

* VA not worse than 0.60
* additional clinically relevant ocular or systemic conditions may be excluded

Primary outcomes:
measure: Mean Intraocular Pressure (IOP)
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04125472: Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1
Official title: Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Primary Hyperoxaluria
Keywords: Hyperoxaluria
Primary Hyperoxaluria
Kidney Diseases
Urologic Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
RNA Therapeutic
siRNA
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-10-14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to provide expanded access to lumasiran for adults and pediatric patients with Primary Hyperoxaluria Type 1 (PH1),

Detailed description: Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join a research study. To learn more about this study, please have your doctor contact the study research staff using the Contacts provided. For general information, see the link provided in More Information.

Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of Primary Hyperoxaluria Type 1

Exclusion Criteria:

* Clinically significant health concerns (with the exception of PH1)
* Received an investigational agent within 30 days before the first dose of lumasiran or are in follow-up of another clinical study
* Previously or currently participating in lumasiran clinical study
* History of liver transplant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alnylam Pharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References: