louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06889506: Interleukin-4 in Pityriasis Lichenoides Chronica
Official title: Assessment of Interleukin-4 Tissue and Serum Levels in Pityriasis Lichenoides Chronica Patients : a Case- Control Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pityriasis Lichenoides
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: assessment of the level of interleukin 4 (IL-4) in the lesional skin and serum of PLC patients and compare its level with healthy controls.

Detailed description: measuring the level of Interleukin 4 in lesional skin and it's serum level using ELIZA in patients with Pityriasis lichenoides chronica and comparing the levels with healthy controls levels

Eligibility criteria: Inclusion Criteria:

* Patients with pityriasis lichenoides Chronica (PLC): either with the classical presentation papular or hypo-pigmented macules and patches that proved histopathologically to be PLC.
* Both genders
* Age group ≥ 8 years

Exclusion Criteria:

* Patients with other skin diseases
* Patient received treatment for PLC within period less than three months
* Pregnant patients
* Lactating patients

Primary outcomes:
measure: Assessment of tissue and serum levels of interleukin 4 (IL -4) in pityriasis lichenoides chronica (PLC) patients and normal controls.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03186599: Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer
Official title: Analysis of Initial Adherence and Its Impact on Long-term Adherence to Hormonal Therapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Medication Event Monitoring System
adherence
Lead sponsor: Gachon University
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
First posted: 2017-06-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A trial will be conducted on 200 breast cancer patients with adjuvant hormonal therapy. The study included 6 months baseline measurement, and 12 months intervention. Patients will be assigned to high adherence or low adherence group. Then, through randomization, low adherence patients will be assigned to the intervention or control group. Study Coordinator delivers the intervention using the WALKON mobile application. Control participants receive usual care with continuous monitoring using Medication Event Monitoring System (MEMS) device.

Detailed description: * Baseline measurement (n=200): screening and enrollment
* 3-month visit: collecting MEMS data
* 6-month visit: collecting MEMS data and assigned to the high adherence (n=70) or low adherence group (n=75). The low adherence intervention group (n=75) will be educated about the WALKON mobile application.
* 12-month visit: Control group: collecting MEMS data intervention group: monthly calls + collecting MEMS data
* 18-month visit: collecting MEMS data and interview

Eligibility criteria: Inclusion Criteria:

* Stage 0-III breast cancer
* Treated with Adjuvant hormonal therapy

Exclusion Criteria:

* Stage IV breast cancer
* Breast cancer recurrence or metastasis
* Severe medical illness

Primary outcomes:
measure: physical activity (daily steps)
timeFrame: 12 months
Secondary outcomes:
measure: Medication adherence using MEMS device
timeFrame: 18 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical center
Study officials:
affiliation: Gachon University
name: Yul ha Min, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06003699: Mindfulness Training in the Medical Health Care System
Official title: Mindfulness Training in the Medical Health Care System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Stress
Emotion Regulation
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to look at how mindfulness-informed emotional intelligence training may influence how participants think, feel, and act.


Eligibility criteria: Inclusion Criteria:

1. Individuals who are between 18 and 80 years of age
2. Individuals who are fluent English speakers
3. Individuals who are able to adequately and independently use electronic devices, such as a laptop, computer, or tablet, and have Internet connection
4. Individuals who are willing and able to consent to participate in the study

Exclusion Criteria:

1. Individuals with an active and untreated mental health issue and/or hospitalization for psychological/mental health issues within the past month

Primary outcomes:
measure: Change in Positive Affect
timeFrame: Baseline, up to 11 weeks
measure: Change in Negative Affect
timeFrame: Baseline, up to 11 weeks
measure: Change in Perceived Stress
timeFrame: Baseline, up to 11 weeks
measure: Change in Decentering
timeFrame: Baseline, up to 11 weeks
measure: Change in Mindfulness
timeFrame: Baseline, up to 11 weeks
measure: Change in Leadership Self-Awareness
timeFrame: Baseline, up to 11 weeks
measure: Change in Workplace Emotional Intelligence
timeFrame: Baseline, up to 11 weeks
Secondary outcomes:
measure: Change in Attentional Performance
timeFrame: Baseline, up to 11 weeks
measure: Change in Depression and Anxiety
timeFrame: Baseline, up to 11 weeks
measure: Change in Burnout
timeFrame: Baseline, up to 11 weeks
measure: Change in Flourishing
timeFrame: Baseline, up to 11 weeks
measure: Change in Sleep
timeFrame: Baseline, up to 11 weeks
Other outcomes:
Locations:
city: Grand Blanc
country: United States
facility: McLaren Health Care Corporation
state: Michigan
Study officials:
affiliation: University of Miami
name: Amishi Jha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03388099: Impact of Gonadotrophin REceptor Polimorphisms on the Relationship Between Serum AMH and Ovarian Response
Official title: Impact of Gonadotrophin REceptor Polimorphisms on the Relationship Between Serum AMH and Ovarian Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: antimüllerian Hormone and Gonadotrophin Receptor Polymorphism as Predictors of Ovarian Response
Keywords: gonadotrophin receptor polymorphism
antimüllerian hormone
ovarian response
ovarian stimulation
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 296
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile Patients undergoing IVF treatments

Brief summary: Aim of study: To compare the relationship between serum AMH and ovarian response for IVF with the GnRH antagonist protocol in patients who are carriers of FSH and/or LH receptor polymorphisms with those that are not.

Detailed description: Serum AMH has shown to have a high predictive capability of the ovarian response to stimulation for IVF. On the other hand, patients who are carriers of polymorphisms in the FSH and LH receptors, have shown to need higher doses of gonadotrophins for ovarian stimulation. The proportion of carriers has been described to be around 20% of the population. Nevertheless, the determination of these polymorphisms is not performed in routine practice. It is unknown if their presence affects to the relationship between serum AMH levels and ovarian response.

This is a prospective, single center, non-interventional, cohorts study.

Eligibility criteria: Inclusion Criteria:

* 18-45 years of age presenting to IVF clinic
* BMI of 18-35 kg/m2
* Having been tested for serum AMH with the Elecsys assay
* Being planned to undergo ovarian stimulation cycle for IVF with the GnRH antagonist protocol
* Signed written informed consent or waiver

Exclusion Criteria:

* Current or past disease affecting ovaries, gonadotropin or sex steroid
* Current hormone therapy

Primary outcomes:
measure: Gonadotrophin receptor polymorphisms and ovarian response and AMH value
timeFrame: 1 year
Secondary outcomes:
measure: polymorphisms in the FSH receptor (FSHR) variant N680S
timeFrame: 1 year
measure: polymorphisms in the LH receptor (LHR) variant N312S
timeFrame: 1 year
measure: Doses of gonadotrophin needed and polymorphisms
timeFrame: 1 year
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Valencian Institute of Infertility, IVI RMA. Valencia
Study officials:
References:
Clinical trial NCT06956599: Hypersensitivity Reduction Efficacy: 5% Potassium Nitrate Toothpaste Compared to Colgate Cavity Protection Toothpaste
Official title: Clinical Investigation of Hypersensitivity Reduction Efficacy: 5% Potassium Nitrate Toothpaste Compared to Colgate Cavity Protection Toothpaste
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Dentin Hypersensitivity
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2025-05-04
Enrollment: 80
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: Assess the clinical efficacy of 5% Potassium Nitrate Toothpaste (Colgate-Palmolive Company, New York, NY, USA) on providing dentinal hypersensitivity relief (tactile and air blast) in comparison to Colgate Cavity Protection Toothpaste (Colgate-Palmolive Company, New York, NY, USA) over an eight-week period


Eligibility criteria: Inclusion Criteria:

* Male and female subjects, ages 18-70, inclusive.- Availability for the eight-week 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 10-50 gms. 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 a 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.
* Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily use of analgesics.
* 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.
* Use in the past of the three test dentifrices.

Primary outcomes:
measure: tactile sensitivity
timeFrame: baseline and 4 weeks, 8 week measurement
Secondary outcomes:
measure: air blast sensitivity
timeFrame: baseline and 4 weeks, 8 week measurement
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02614599: Neurocognitive and Neurobiological Improvement in ADHD Children With High Protein Diet
Official title: Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: ADD
ADHD
Keywords: ADD
ADHD
Proteins
Dietary
Nutrition
QEEG
ERP
ICA
Lead sponsor: Spanish Foundation for Neurometrics Development
Sponsor class: OTHER
Collaborators: name: PronoKal Foundation
name: Child Health Foundation
First posted: 2015-11-25
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Multicenter, Prospective, randomized, comparative and controlled study about the beneficial effects in behavior and brain connectivity of different dietary patterns in 100 children with ADHD between 7 and 12 years, followed up for 3 months of nutritional therapy.

Detailed description: We collect electroencephalogram (EEG), event related potentials (ERP) data, and behavior parameters in ADD/ADHD children that not take stimulants or other drugs during study. They would only follow some nutritional recommendations based on increasing the amount of dietary protein and fast carbohydrates decrease. The duration of the study will be 6 months, 3 months for recruitment and 3 months for dietary treatment.

Eligibility criteria: Inclusion Criteria:

* ADHD diagnosed 12 months before
* no take medication
* BMI above the 25th percentile
* Wiesel score between 80 and 100 (about 120)
* Patients who agree to participate and whose guardians signed the informed consent form

Exclusion Criteria:

* eating disorders
* psychosis, bipolar disorder or depression
* kidney or liver failure
* diabetes
* diuretic or cortisone treatment
* haematological problems
* suprarenal diseases
* cancer
* Brain injury
* Cardiovascular or arrhythmia problems

Primary outcomes:
measure: Changes Related Potential Recording after 3 months of dietary approach
timeFrame: 3 months
Secondary outcomes:
measure: Quantitative Electroencephalogram
timeFrame: 3 months
measure: Behavior
timeFrame: 3 months
Other outcomes:
measure: Change in Weight
timeFrame: 3 months
measure: Change in body mass index
timeFrame: 3 months
measure: Change in body composition
timeFrame: 3 months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: From April to December 2013
Locations:
Study officials:
References:
Clinical trial NCT05754099: Identification of Clinically Significant Markers of ATTRv in Pre-symptomatic Mutation Carriers.
Official title: Identification of Clinically Significant Markers of Hereditary Transthyretin Amyloidosis (TTR) in Pre-symptomatic Mutation Carriers: a Prospective Longitudinal Multicentre Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amyloidosis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data from pre-symptomatic carriers who have signed the written informed consent, in regular follow-up at the Centres, will be included in the study. Carriers recruited should be no less than 10 years of age compared to the age of onset of the affected relative with the youngest age of onset or should have a history of bilateral carpal tunnel syndrome undergoing surgery.

Brief summary: The objective of this prospective observational study is to periodically monitor pre-symptomatic subjects carrying a mutation of Transthyretin (TTR), identified in the context of a family screening of affected proband, through instrumental methods and clinical scales in order to identify the first signs of clinically significant organ involvement by the disease. Healthy asymptomatic carriers will be subjected to regular monitoring through clinical evaluations and instrumental investigations defined by the consensus group (Conceicao et al.) in order to validate the criteria defined by this group to define the onset of the disease. A subgroup of carriers with scales and instrumental tests negative for damage to the peripheral nervous system or cardiac, but with subjective symptoms compatible with the disease, will be subjected to further instrumental tests not indicated by consent.


Eligibility criteria: Inclusion criteria

1. Pre-symptomatic carriers of TTR mutation in regular follow-up at the Centres.
2. Signature of the written informed consent.
3. Age not less than 10 years compared to the age of onset of the relative with the youngest age of onset and/or a history of bilateral carpal tunnel syndrome undergoing surgery.

Exclusion criteria

* Other causes of neuropathies (diabetes; MGUS; alcoholism; vitamin deficiency).
* Other causes of hypertrophic heart disease.

Primary outcomes:
measure: Evaluation of a cohort of pre-symptomatic subjects carrying a TTR mutation
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Flavia Torlizzi
Study officials:
References:
Clinical trial NCT02257099: CT Analysis of the Patellofemoral Joint in Patients Having Knee Surgery
Official title: Comparison of a Novel Weight Bearing Cone Beam Computed Tomography (CT)Scanner Versus a Conventional CT Scanner for Measuring Patellar Instability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patellar (or Kneecap) Instability and Mal-alignment
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Carestream Health, Inc.
First posted: 2014-10-06
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with acute or chronic patellar malalignment.

Brief summary: The primary hypothesis is that measures of patellofemoral alignment obtained from the investigational cone beam CT scanner will be reduced, but still correlated to those obtained from the conventional CT scan.


Eligibility criteria: Inclusion Criteria:

* Patients who have been diagnosed with acute or chronic patellar malalignment.
* At least 16 years old
* Be willing and able to provide informed consent

Exclusion Criteria:

* Open growth plates
* Previous knee surgery on the affected knee
* Pregnancy (females)
* Fracture of the patellofemoral joint
* Knee ligament injury (other than medial patellofemoral ligament)
* Have greater than Grade II degenerative changes of the patellofemoral joint
* Inability to bear weight on the extremity during the CT scan

Primary outcomes:
measure: Congruence Angle CBCT
timeFrame: Baseline
Secondary outcomes:
measure: Tilt Angle
timeFrame: Baseline
measure: Tibial Tuberosity Trochlear Groove
timeFrame: Baseline
Other outcomes:
Locations:
city: Amherst
country: United States
facility: UBMD Orthopaedics and Sports Medicine, Northtowns office
state: New York
city: Orchard Park
country: United States
facility: UBMD Orthopaedics and Sports Medicine, Southtowns Office
state: New York
Study officials:
References:
Clinical trial NCT03402399: Defining the Molecular Risk in Israeli Patients With Secondary Compared to Primary Myelofibrosis
Official title: Defining the Molecular Risk in Israeli Patients With Secondary Compared to Primary Myelofibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myelofibrosis, Primary
Myelofibrosis, Post PV
Myelofibrosis, Post ET
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-01-18
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to determine the rate of HMR mutations in PMF and secondary MF (post PV/ET) subjects, and correlate the rate of mutations with clinical features as known prognostic scores.

Detailed description: Main inclusion criteria:

1. Diagnosis of PMF, post PV MF or post ET MF according to the WHO 2008 classification
2. Age ≥ 18 years
3. Concurrent participation in clinical trials will be allowed.

Efficacy assessments will be evaluated by: HMR mutations rate, specific HMR mutations, disease duration, presence of splenomegaly, cytogenetic risk, DIPPS, IPSS, ET survival score and PV survival score.

The primary efficacy parameter to be assessed will be HMR mutation rate.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of PMF, post PV MF or post ET MF according to the WHO 2008 classification
2. Age . 18 years
3. Patient is willing and capable of giving a written informed consent.
4. Concurrent participation in clinical trials will be allowed

Exclusion Criteria:

1. Unwilling or unable to provide informed consent
2. Prefibrotic MF

Primary outcomes:
measure: Rate of patients with one or more HMR mutations in primary compared to secondary (post PV/ET) MF
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Maya Koren-Michowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: