louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06782269: Incidence of Subtalar Joint Fusion After Isolated Ankle Fusion
Official title: Incidence of Subtalar Joint Fusion After Isolated Ankle Fusion
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ankle Arthritis
Lead sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Sponsor class: OTHER_GOV
First posted: 2025-01-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have had an isolated ankle fusion.

Brief summary: It is important to know a truer incidence of the need for subtalar and midfoot fusions, following an isolated ankle fusion, in order to better inform our patients of the likelihood of needing further surgery in the future. It is also important to understand whether pre-existing radiological arthrosis is likely to lead to the need for a fusion in the future and also how important the alignment of the ankle joint, after a fusion, may influence that.

The aim of the study is to review the patients' notes and radiology who have had a previous isolated ankle fusion and then to see whether they subsequently required further surgery.

Detailed description: Isolated ankle fusion is normally regarded as a good operation producing good pain relief and allowing patients to function well. Patients will have an early heel rise when walking and although that is often not immediately perceptible to an onlooker, it does increase the stress on the neighbouring subtalar and Chopart joints. Radiologically, subtalar joint arthrosis is common following isolated ankle fusions but not necessarily clinically symptomatic. The long term incidence of subsequent ipsilateral subtalar or Chopart joint fusions is not well known. Various different studies have shown a prevalence of osteoarthrosis (radiologically) of 24-100% in the subtalar joint and reported 84% of patients complaining of pain after 10 years. The prevalence in the Chopart joints has been reported to vary between 18-77%.

This is an observational study reviewing medical records and radiology of patients who have had an isolated ankle fusion. The data will be analysed using basic statistics with logistic regression modelling.

Eligibility criteria: Inclusion Criteria:

Any patient who has had an isolated ankle fusion and is over the age of 18 years old.

Exclusion Criteria:

Participants younger than 18 years old.

Primary outcomes:
measure: incidence of subtalar and midfoot fusions after isolated fusion of the ankle joint
timeFrame: A retrospective data collection following patients from surgery to now.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00202969: Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer
Official title: An Open-label, Multicenter, Randomized, 3 Arm Study of S-1 Compared With S-1/CDDP, or S-1/CDDP Compared With 5-FU/CDDP in Patients With Advanced Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Stomach cancer
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 180
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: This is an open-label, multicenter, three arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1 alone compared with S-1 plus CDDP, and S-1 plus CDDP compared with 5-FU plus CDDP in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1:1) to S-1 (Arm A), S-1/CDDP (Arm B) or 5-FU/CDDP (Arm C). Patients will be stratified to achieve balanced distribution of patients to each arm according to following stratifications, performance status (0, 1, or 2), the number of metastatic sites (1 vs \>1), prior gastrectomy, and center.


Eligibility criteria: Inclusion Criteria:

* Non-prior chemotherapy treated advanced gastric adenocarcinoma
* Age 18 and over
* Performance status 0, 1, or 2 (ECOG)
* Life expectancy 3 months
* Hematopoietic WBC lower limit of normal-12,000/mm\^3 Absolute granulocyte count ≥ 2,000/mm\^3 Platelet count ≥ 100,000/mm\^3 Hemoglobin ≥ 8.0 g/dL
* Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL
* Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 60 mL/min

Exclusion Criteria:

* Interstitial pneumonia, pulmonary fibrosis
* Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure
* Intestinal paralysis, intestinal obstruction, uncontrollable diabetes

Primary outcomes:
measure: Response rate
timeFrame: every course for first three courses, then every other course
Secondary outcomes:
measure: Safety profile, time to treatment failure
timeFrame: any time
Other outcomes:
Locations:
city: No.52 Fu-Cheng Road, Hai-dian District
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jin Maolin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06953869: Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Official title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Insomnia Disorder
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-05-01
Enrollment: 420
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.


Eligibility criteria: Inclusion Criteria:

* Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).
* Confirmed clinical diagnosis of insomnia disorder
* Males and Females between 2 and 17 years, inclusive.
* The sleep disturbance must not be a result of another medication.

Exclusion Criteria:

* Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.
* Indication of impaired liver function.
* Pregnant or lactating females.
* A positive test for drugs of abuse.

Primary outcomes:
measure: Change in sleep latency, as measured by daily sleep diary.
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change in nighttime subjective sleep parameters, such as sleep quality, as measured by sleep diary.
timeFrame: 12 Weeks
measure: Change in nighttime subjective sleep parameters, such as sleep time, as measured by sleep diary.
timeFrame: 12 Weeks
measure: Change in daytime functioning, as measured by questionnaire.
timeFrame: 12 Weeks
measure: Change in behavior, as measured by questionnaire.
timeFrame: 12 Weeks
measure: Change in nighttime objective sleep parameters such as sleep time, as measured by actigraphy.
timeFrame: 12 Weeks
measure: Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Winter Park
country: United States
facility: Vanda Investigational Site
state: Florida
city: Charlotte
country: United States
facility: Vanda Investigational Site
state: North Carolina
city: San Antonio
country: United States
facility: Vanda Investigational Site
state: Texas
Study officials:
References:
Clinical trial NCT01040169: Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction
Official title: Clinical Efficacy of a Toothpaste on Hypersensitivity Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypersensitivity
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2009-12-29
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tooth sensitivity reduction after dentifrices use


Eligibility criteria: Inclusion Criteria:

* Male and female subjects, ages 18-70, inclusive.
* Availability for the three month duration of the study.
* Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
* Qualifying response to tactile stimuli (Yeaple probe) as defined by a score between 10-50gms. of force.
* Qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
* Subjects need to satisfy the qualifying response to stimuli for both the parameters assessed (tactile or air) on two teeth to be entered into the study.
* Good general health with no known allergies to products being tested.
* Use of a non-desensitizing dentifrice for three months prior to entry into the study.
* Signed Informed Consent Form.

Exclusion Criteria:

* Gross oral pathology, chronic disease, or history of allergy to test products.
* Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
* Sensitive teeth with mobility greater than one.
* Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
* Subjects that began to take anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily analgesics within one month prior to the start of the study or who have to start taking these during the course of the study.
* Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past three months.
* Current participation in any other clinical study.
* Pregnant or lactating subjects.
* Allergies to oral care products, personal care consumer products, or their ingredients.
* Medical condition which prohibits not eating/drinking for 4 hours.

Primary outcomes:
measure: Tooth Hypersensitity to Touch Stimuli (Tactile)
timeFrame: 12 weeks (Final)
measure: Tooth Hypersensivity Stimuli to Air
timeFrame: 12 weeks (Final)
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Jacobsen Dental Clinic
state: California
Study officials:
name: Thomas Schiff, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03546946: Investigating Attention Patterns in Young People With Anxiety
Official title: Investigating Attention Patterns in Young People With Anxiety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Adolescent Behavior
Keywords: Attention
Anxiety
Adolescence
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2018-06-06
Enrollment: 99
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Adolescents with elevated anxiety have been found to direct their voluntary and involuntary attention more readily toward threatening stimuli, and spend more time dwelling upon that stimuli. Various computerised tasks have been developed to attempt to retrain these "attention biases" back away from threat.

This study will test a newly developed intervention, that uses (eye-tracking) methods to track the gaze of the individual. This intervention is called Gaze-Contingent Music Reward Training (GC-MRT), and is designed to re-train the individual away from dwelling upon threatening stimuli (emotional faces), using their favourite music to re-infornce this learning.


Eligibility criteria: Inclusion Criteria:

* 12-18 years of age upon study commencement
* Diagnosed generalised or social anxiety disorder (assessed by SCID)
* Informed written and witnessed consent

Exclusion Criteria:

* Psychosis
* Autism
* Learning difficulties
* Uncorrected abnormal vision
* Current use of SSRIs

Primary outcomes:
measure: Change in anxiety symtoms
timeFrame: Baseline and post-intervention (4 weeks), and at 3-month follow up.
Secondary outcomes:
measure: Change in Self-report Anxiety
timeFrame: Baseline and post-intervention (4 weeks), and at 3-month follow up.
measure: Change in Dwell time on negative faces
timeFrame: Baseline and post-intervention (4 weeks), and at 3-month follow up.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
state: England
Study officials:
References:
Clinical trial NCT00250146: Multicenter Study on the Toxicity of Gluten Traces in the Treatment of Celiac Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Celiac Disease
Keywords: Celiac Disease
Gluten
Toxicity
Small bowel morphometry
Lead sponsor: Università Politecnica delle Marche
Sponsor class: OTHER
Collaborators: name: Associazione Italiana Celiachia (AIC)
First posted: 2005-11-07
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the toxicity of minute doses of gluten in the treatment of celiac disease, a disorder characterized by permanent intolerance to dietary gluten.

Detailed description: Treatment of celiac disease (CD) is based on the complete avoidance of gluten-containing products in the diet. However it is not known whether tiny amounts of gluten are harmful for patients on long-term treatment. This is an important issue, as even a strict gluten-free diet (GFD) is usually contaminated by traces of gluten, e.g. in wheat starch and processed food. The aim of this study is to investigate the toxicity of the prolonged ingestion of gluten traces in treated CD patients. This is a prospective, placebo-controlled, double-blind study. Patients are adults with biopsy-proven CD on treatment with the GFD for at least 2 years. During the study period their background daily gluten intake is kept lower than 5 mg. After baseline evaluation, patients continue their GFD and are assigned to ingest 0 mg, 10 mg or 50 mg of daily gluten (incorporated in a capsule) for 90 days. The following evaluations are performed both at baseline and after the micro-challenge: clinical, serological (anti-transglutaminase and antigliadin antibodies), and small intestine histology.

Eligibility criteria: Inclusion Criteria:

adults with biopsy-proven celiac disease on a gluten-free diet for at least 2 years and in apparent good health -

Exclusion Criteria:

1. patients younger than 18 years old;
2. poor compliance to the gluten-free diet;
3. abnormal results at the baseline evaluation (positivity of anti-tissue transglutaminase (tTG) antibodies and/or definitely abnormal small intestinal biopsy;
4. associated conditions, such as selective IgA deficiency or other autoimmune diseases -

Primary outcomes:
measure: Villous Height/Crypt Depth ratio on small intestinal biopsy
measure: Intraepithelial lymphocyte coun on small intestinal biopsy
measure: changes in serum IgA class anti-trasnglutaminase antibodies
measure: changes in serum IgG class anti-gliadin antibodies
measure: clinical symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: University Department of Pediatrics
Study officials:
affiliation: Department of Pediatrics, Università Politecnica delle Marche, Ancona, Italy
name: Carlo Catassi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03592446: Neural Alteration Response to Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Depressed Patients
Official title: Xidian University,China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Lead sponsor: Xidian University
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Electrical vagus nerve stimulation (VNS) was approved by FDA for treatment of chronic recurrent depression in 2005. Recently, non-invasive, transcutaneous auricular vagus nerve stimulation （taVNS） has already been used for depression treatment. However, the neural mechanism remains unclear, and the relationship between stimulation parameters and neural response were also unknown. The present study aims to investigate the specific brain activation in depression patients after taVNS，compared with healthy controls.


Eligibility criteria: Inclusion Criteria:

* Meets ICD-10 diagnosis standard;
* without taking anti-depressive medication or other psychiatric medications 2 weeks before the experiment;
* Patient has exhibited symptoms for at least 2 months, but no longer than 2 years.

Exclusion Criteria:

* With current addiction to drugs;
* With other severe organic diseases, such as severe heart disease, kidney failure etc;
* disagree with the consent form.
* Cannot receive MRI scan.

Primary outcomes:
measure: actual neural activation in brain
timeFrame: 2 hours
Secondary outcomes:
measure: Heart rate variability
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02496546: An Explorative Trial Evaluating the Effect of LEO 32731 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)
Official title: An Explorative Trial Evaluating the Effect of LEO 32731 Cream 20 mg/g in Adults With Mild to Moderate Atopic Dermatitis (AD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-07-14
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to assess the efficacy of LEO 32731 cream 20 mg/g compared with LEO 32731 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Following verbal and written information about the trial, subjects must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures being carried out
* Subject with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3) as assessed by a dermatologically trained investigator (and confirmed by a board certified dermatologist before or at visit 1)
* Two symmetrically located and comparable Entire Treatment Areas (ETAs) of 20 - 50 cm2 each, i.e. on the same body region (left and right part) and of the same size (complete AD lesion or part of an AD lesion); Total Sign Score (TSS) of at least 5 on both ETAs; difference in TSS not greater than 2 between the two ETAs; sign score for erythema ≥ 2 on both ETAs; difference in Investigator´s Treatment Area assessment of disease severity not greater than 1 between the 2 ETAs

Exclusion Criteria:

* Any condition in the treatment areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash (other than Atopic Dermatitis), sunburn, hyper- or hypopigmentation, scars

Primary outcomes:
measure: Total sign score at end of treatment on entire treatment area
timeFrame: 3 weeks
Secondary outcomes:
measure: Total sign score on limited treatment area on entire treatment area during trial
timeFrame: 3 week
measure: Investigator's treatment area assessment of disease severity on entire treatment area during trial
timeFrame: 3 weeks
measure: Subject's treatment area assessment of disease severity on entire treatment area during trial
timeFrame: 3 weeks
measure: Subject's assessment of itching on entire treatment area during trial
timeFrame: 3 weeks
measure: Transepidermal water loss during trial
timeFrame: 3 weeks
measure: Individual signs score on entire treatment during trial
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Proinnovera GmbH, Center of Dermatology Excellence
Study officials:
References:
Clinical trial NCT04923646: Veteran Primers for CRC Screening
Official title: Primers to Improve Adherence to Annual CRC Screening Among Veterans: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Cancer screening
Behavioral economics
Adherence
Lead sponsor: VA Puget Sound Health Care System
Sponsor class: FED
First posted: 2021-06-11
Enrollment: 2404
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is a prospective, randomized controlled trial that will evaluate the effectiveness of primer postcards sent two weeks prior to the mailing of a FIT kit in improving adherence to annual CRC screening. This project is for the purpose of quality improvement and has been designated as non-research by the VHA Office of Primary Care, Improvement \& Innovation (VHA Program Guide 1200.21).

Detailed description: Veterans eligible for enrollment into the trial will be randomized in a 1:1 allocation using permuted block randomization (with random block sizes of 4 and 8) to the following interventions:

1. Active arm: Primer

   1. Intervention Type: Other
   2. Intervention Description: Mailed postcard notifying Veteran of upcoming FIT kit receipt for annual CRC screening
2. Control arm: No primer a. Intervention Type: No intervention

Randomization will be stratified within arms by prior screening status (prior screener vs. never screener)

Our primary outcome of interest is the return rate at three months post randomization. Our secondary outcome of interest is the return rate at six months post randomization. Enrollment in the trial will occur between May 1, 2021 and January 1, 2022.

Eligibility criteria: Eligible participants are automatically enrolled in this project. We are unable to enroll participants upon request.

Inclusion criteria:

* Veteran
* Assigned to a primary care provider at the VA Puget Sound as of January 1, 2021
* At least 1 year of prior data available (evidence of at least one outpatient visit)
* Due for annual colorectal (CRC) screening

Exclusion criteria:

* Not scheduled for either a screening or diagnostic colonoscopy within the 12 weeks from assessment.
* Not currently receiving hospice care
* No record of recent death in the administrative data.
* No history of CRC or history of prior colectomy.

Primary outcomes:
measure: Return proportion
timeFrame: 3 months
Secondary outcomes:
measure: Return proportion
timeFrame: 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System
name: Ashok Reddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Puget Sound Health Care System
name: Stefanie Deeds, MD
role: PRINCIPAL_INVESTIGATOR
References: