louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00150761: Facial Thermography Study of Levocetirizine Versus Cetirizine
Official title: A Randomized, Double-blind, Double Dummy, Placebo Controlled, Cross-over Exploratory Trial in Healthy Male Adult Subjects: Comparison by Means of Infrared Thermography of the Anti-H1 Potency of Levocetirizine 5 mg and Cetirizine 10 mg Tablet Single Oral Dose After Nasal Histamine Provocation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anti-allergic Agents
Keywords: Nasal histamine provocation, facial thermography, levocetirizine, cetirizine,
Xyzal, Zyrtec
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Phase IV, human pharmacology, exploratory, randomized, 3-way (3 treatment periods) cross-over, double blind, double dummy, placebo controlled study to compare levocetirizine and cetirizine by means of IR thermography.


Eligibility criteria: Inclusion Criteria:

* Healthy male Caucasian subject aged between 18 and 55 years (both inclusive).
* Subject must have a positive prick test to histamine (wheal diameter ≥ 6 mm with histamine dihydrochloride (100 mg/mL) and ≤ 3 mm with diluent control).

Exclusion Criteria:

* History of allergic disease, documented or suspected, including but not limited to: asthma, whether or not considered as allergic; nocturnal cough episode suspected to be of asthma-equivalent nature (three or more consecutive nights resulting in sleep disturbances) ; allergic rhinitis, conjunctivitis or sinusitis; nasal polyposis; dermatitis of the face or neck; drug or food allergy.
* Any clinically significant vascular disease such as hyper- or hypotension, venous disorder, vasculitis etc.
* History of hot flushes and any other vasomotor disorders.
* ENT infection or Upper Respiratory Tract Infection not completely cured at least one week before inclusion.
* Any known history of laryngeal edema.
* Nasal structural abnormalities (e.g. deviation of the nasal septum...).
* Recent immunotherapy
* Skin irritants or UV exposure 48 hours before each visit.

Primary outcomes:
measure: To compare by means of infrared (IR) thermography the anti-histaminic potency of levocetirizine 5mg (single dose) and cetirizine 5mg (single dose) using a placebo as control following 2 nasal histamine provocations (NHP) performed respectively 10 minutes
Secondary outcomes:
measure: To assess and compare onset of action of levocetirizine 5 mg and cetirizine 10 mg
measure: To explore predictive value of screening thermography parameters on treatment effect
measure: To collect additional safety information on levocetizine
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05305261: Mother to Child Transmission of Antibody to Covid-19 The TRAB CoV-19 Study.
Official title: Maternal to Neonatal Transmission Antibody Covid-19 Study - The TRAB CoV-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibody
Vaccine
Maternal
Cord
Keywords: Covid-19
antibody
pregnancy
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
Collaborators: name: Malaysia Automotive Robotics and Innovation of Technology Institute
First posted: 2022-03-31
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All vaccinated pregnant women at term with or without a history of covid-19 infection admitted in labour

Brief summary: This is a prospective clinical study aiming to investigate on the transplacental antibody transmission post Covid-19 infection during pregnancy.

Detailed description: Covid -19 infection has been a significant public health burden as it shifted the paradigm of infectious diseases aiming to control the spread and enhance public immune protection. The introduction of Covid -19 vaccination in December 2020 aimed to combat the infection, thus tremendously helping to flatten the disease worldwide. Channeling the vaccine for the obstetrics field is one of the hallmark strategies to reduce maternal morbidity and mortality. The efficacy of vaccination for the pregnant lady has been established. However, fetus protection via transmission of the antibody during pregnancy is still uncertain. Therefore, this study aims to consolidate further evidence of transplacental antibody post-maternal vaccination aiming for fetal protection following delivery.

Eligibility criteria: Inclusion Criteria:

* term pregnancies at 37 weeks or more
* vaccinated 2 doses
* in labour

Exclusion Criteria:

* unvaccinated
* preterm labour less than 37 weeks
* multiple pregnancies

Primary outcomes:
measure: Maternal to Neonatal Transmission Antibody Covid-19 Study - The TRAB CoV-19
timeFrame: 30 minutes after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: UKM Medical Center
state: W.Persekutuan
Study officials:
References:
Clinical trial NCT03370861: How Microbes and Metabolism May Predict Skin Cancer Immunotherapy Outcomes
Official title: Immunotherapy Multi-omics Specimen Protocol A
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Autoimmunity
Melanoma
Merkel Cell Carcinoma
Squamous Cell Carcinoma of the Skin
Basal Cell Carcinoma
Skin Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with skin cancer planning to initiate or already on ANY type of immunotherapy.

Brief summary: The purpose of this research study is to examine the relationship between the microbiota (microscopic organisms) in the gut and the activity of the immune system during skin cancer immunotherapy.

Detailed description: Details will be available upon publication.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age.
* Diagnosis of skin cancer.
* Planning to initiate or already on ANY type of immunotherapy.
* Able to provide urine and stool specimens.

Exclusion Criteria:

* Bowel resection.
* Major GI surgery in the past 5 years other than cholecystectomy and appendectomy.

Primary outcomes:
measure: Immune-related Adverse Events (irAEs)
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Hosptial
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: William H McCoy IV, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01667861: Risk Factors for Glaucoma in Musicians
Official title: Risk Factors for Glaucoma in Musicians
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: Glaucoma
Wind instruments
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Stichting Glaucoomfonds
First posted: 2012-08-17
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (Professional) musicians, who play in symphony or wind orchestras.

Brief summary: The purpose of this study is to determine the impact of playing wind instruments for the development of ocular hypertension and glaucoma, together with investigating the prevalence of visual problems and eye diseases in (professional) musicians.


Eligibility criteria: Inclusion Criteria:

* All full time or part time professional players of participating symphony or wind orchestras, including guest players.
* Retired players, if possible.

Exclusion Criteria:

* Difficulty in reading or speaking Dutch.

Primary outcomes:
measure: IOP levels, including IOP peaks occurring during or directly after playing, and prevalence of glaucomatous field loss in players of wind instruments.
timeFrame: One hour.
measure: IOP peaks and variations during continuous IOP monitoring
timeFrame: 24 hours
Secondary outcomes:
measure: Risk factors for glaucoma and the prevalence of visual problems and eye disease among (professional) musicians
timeFrame: 2 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Eye Clinic, Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center, NL
name: Henny JM Beckers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00634361: Ethyl-EPA Treatment of Prodromal Patients
Official title: Ethyl-EPA Treatment of Prodromal Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia Prodrome
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 7
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label trial of an omega-3 fatty acid for symptoms of the schizophrenia prodrome.


Eligibility criteria: Inclusion Criteria:

* meets criteria for schizophrenia prodrome

Exclusion Criteria:

* any lifetime antipsychotic treatment

Primary outcomes:
measure: conversion to psychosis
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Scott W Woods, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06503861: Community-designed Food Is Medicine for Adults With Diabetes
Official title: Southern Indiana Farm to Health Initiative: Evaluation of Produce Prescription Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 61
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 goal of this clinical trial is to learn if an educational intervention can affect clinical outcomes in adults with diabetes. The main question it aims to answer is:

Can a Food Is Medicine intervention affect obesity and/or diabetes markers in adults?

Researchers will compare a Food Is Medicine arm to a control arm to answer the research question.

Participants will provide biometrics and questionnaire responses at three time points. Those in the Food Is Medicine arm will receive regular free meal kits combined with cooking and nutritional education.


Eligibility criteria: Inclusion Criteria:

* Age 18+ years, weight 100+ pounds, HbA1c \>7% in 2020

Exclusion Criteria:

-

Primary outcomes:
measure: Participants' diabetes level or severity
timeFrame: Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)
measure: Participants' obesity level or severity
timeFrame: Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)
Secondary outcomes:
measure: Dietary behaviors
timeFrame: Three time points over approximately 9 months (time1 baseline, time 2 post-intervention, time 3 long-term)
Other outcomes:
Locations:
city: Paoli
country: United States
facility: Southern Indiana Community Health Care
state: Indiana
Study officials:
affiliation: Indiana University
name: Julia CD Valliant, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06450561: Adherence to Secondary Prevention Guidelines for Cardiovascular Risk
Official title: Adherence to Secondary Prevention Guidelines for Cardiovascular Risk
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atherosclerosis
Stroke, Ischemic
Acute Coronary Syndrome
Ischemic Heart Disease
Peripheral Arterial Disease
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized due to a cardiovascular event

Brief summary: The present observational study aims to determine the degree of adherence to the recommendations of clinical guidelines regarding the prevention of cardiovascular complications in patients hospitalized due to a cardiovascular event.


Eligibility criteria: Inclusion Criteria:

* Admitted to the cardiology, neurology, or general surgery departments
* With any of the following admission diagnoses:

Non-ST-segment elevation acute coronary syndrome (NSTEACS) ST-segment elevation acute coronary syndrome (STEACS) Stable angina Unstable angina Non-ST-segment elevation myocardial infarction (NSTEMI) ST-segment elevation myocardial infarction (STEMI) Atherothrombotic ischemic stroke Lacunar stroke Peripheral artery disease Chronic ischemia of lower limbs Vascular ulcer due to arterial cause

Exclusion Criteria:

* Patients for whom lipid-lowering treatment is ruled out due to limited life expectancy
* Patients likely to die during hospitalization
* Patients who died during hospitalization

Primary outcomes:
measure: patients admitted for a cardiovascular event who are prescribed lipid-lowering treatment at discharge
timeFrame: At hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Sant Pere De Ribes
country: Spain
facility: Consorci Sanitari Alt Penedes i Garraf-Hospital Sant Camil
state: Barcelona
Study officials:
affiliation: CSAPG
name: Lidia Tikhomirova
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01324661: The Protective Effect of Friendship on Peer Rejection in Overweight and Normal Weight Youth
Official title: The Protective Effect of Friendship on Peer Rejection in Overweight and Normal Weight Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Exclusion
Control
Lead sponsor: University at Buffalo
Sponsor class: OTHER
First posted: 2011-03-29
Enrollment: 104
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study examines youth's motivation for food or social rewards after a brief episode of simulated ostracism. The investigators hypothesize that youth who think about a friend after being ostracized will mediate their decision to resort to food, which is typically evidenced in socially isolated overweight youth.


Eligibility criteria: Inclusion Criteria:

* General liking for all study foods

Exclusion Criteria:

* Food allergies
* Medical or Psychological disorders

Primary outcomes:
measure: Amount of food consumed after playing a computer game
timeFrame: Measured once during this 3-6 month study
measure: The number of points earned for a snack food or social interaction.
timeFrame: Measured once during this 3-6 month study
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo Division of Behavioral Medicine
state: New York
Study officials:
References:
Clinical trial NCT06791161: A Multicenter Prospective Cohort Study of Adjuvant Therapy for BRCA1/2 Mutated Hormone Receptor-positive HER2-negative Early High-risk Breast Cancer
Official title: A Multicenter Prospective Cohort Study of Adjuvant Therapy for BRCA1/2 Mutated Hormone Receptor-positive HER2-negative Early High-risk Breast Cancer
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast
Keywords: BRCA1/2 mutation
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: BRCA gene mutation HR+/HER2- Early high-risk breast cancer

Brief summary: To evaluate the efficacy and safety of different adjuvant treatment options after surgery for early high-risk breast cancer with BRCA1/2 mutation HR+/HER2


Eligibility criteria: Inclusion Criteria:

* ECOG score 0-1
* ER\>10%, PR\>10%, HER2(0)/HER2(1+)/HER2(2+) and no amplification of FISH
* BRCA1/2 gene mutation
* No other site metastases were detected by imaging evaluation after surgical treatment
* Non-PCR breast cancer after neoadjuvant therapy, or breast cancer with postoperative pathology indicating ≥pN2
* The patient had no major organ dysfunction

Exclusion Criteria:

* Allergic to the investigational drug, inability to take the drug orally, or refusal of the medication regimen
* Has been enrolled in another study or has been discontinued for less than or equal to 4 weeks
* There is serious dysfunction of vital organs (heart, liver, kidney)
* Patients with other malignancies, except cured non-melanoma skin cancer, cervical carcinoma in situ and other tumors that have been cured for at least 5 years
* In other acute infectious disease or chronic infectious disease activity period
* A history of uncontrolled seizures, central nervous system disorders, or mental disorders
* There is a known history of human immunodeficiency virus

Primary outcomes:
measure: Invasive Disease-Free Survival rate
timeFrame: 3 years
Secondary outcomes:
measure: Distant relapse-free survival rate
timeFrame: 3 years
measure: Overall survival rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
Clinical trial NCT04825561: A Study to Evaluate the Efficacy and Safety of AD-208
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AD-208 in Male Patients With Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Androgenetic Alopecia
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 139
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of AD-208.

Detailed description: The purpose of this study is to evaluate the efficacy and safety of AD-208 in male patients with androgenetic alopecia.

Eligibility criteria: Inclusion Criteria:

* Male patients aged 18-50 years, inclusive
* Patients who meet the appropriate criteria according to the classification of hair loss
* Signed informed consent

Exclusion Criteria:

* Patients with hair loss disorders other than androgenetic alopecia
* Other exclusions applied

Primary outcomes:
measure: The amount of Change in the total number of hairs
timeFrame: Baseline, Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Study officials:
References:
Clinical trial NCT02147561: A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine Disorders
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-05-26
Enrollment: 280
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: This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with chronic migraine.


Eligibility criteria: Inclusion Criteria:

* Ethnically Korean with a diagnosis of chronic migraine

Exclusion Criteria:

* Anticipated need for botulinum toxin treatment for any reason other than chronic migraine during the study
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

Primary outcomes:
measure: Percentage of Patients With Adverse Events
timeFrame: 28 Days
Secondary outcomes:
measure: Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score
timeFrame: Baseline, Day 28
measure: Physician Global Assessment of Outcome on a 3-Point Scale
timeFrame: Baseline, Day 28
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05456061: Effect of ADDE on Tear Interferometry
Official title: Effect of Aqueous-Deficient Dry Eye on Lipid Layer Thickness Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tear
Dry Eye Syndromes
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 152
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were classified into four groups: control group (Group 1), 3% diquafosol group (Group 2), punctal plug insertion group (Group 3), and combined treatment group (Group 4).
Primary purpose: DIAGNOSTIC

Brief summary: Importance: Lipid layer thickness (LLT) reflects the lipid components of tear film, but is affected by the mucocutaneous components. This study investigated the therapeutic effect of the treatments for aqueous-deficient dry eye (ADDE) on LLT.

Objective: To investigate the effect of ADDE and its treatments on LLT measurements by tear interferometry.

Design, Setting, and Participants: This prospective comparative interventional study included 152 eyes from 152 patients with ADDE.

Interventions: Participants were classified into four groups: control group (Group 1), 3% diquafosol group (Group 2), punctal plug insertion group (Group 3), and combined treatment group (Group 4).

Main Outcomes and Measures: Average LLT (LLTave) was measured using a LipiView® II tear interferometer at baseline and one month after treatments.


Eligibility criteria: Inclusion Criteria:

1. presence of one or more subjective symptoms of DED, including eye dryness, foreign body sensation, irritation, burning, blurred vision, and pain.
2. tear meniscus height (TMH) of \<200 µm for aqueous deficiency measured using Keratograph 5M® (Oculus Optikgeräte GmbH, Wetzlar, Germany).
3. evidence of corneal and/or conjunctival damage on slit-lamp biomicroscopy with fluorescein staining.

Exclusion Criteria:

1. acute and chronic ocular surface diseases that affect DED, including infection, allergy, and autoimmune disease, and that interfere with tear interferometric measurements, such as corneal opacity and pterygium, were excluded.
2. a history of the use of contact lens, known systemic diseases such as Sjögren's syndrome, Stevens-Johnson syndrome, and ocular graft-versus-host disease.
3. any medical/surgical history related to tear production and tear function except that in the study protocol were excluded.
4. Hypersecretory meibomian gland dysfunction (MGD)

   * When both eyes of a patient could be included, an eye with the lower TMH was selected.

Primary outcomes:
measure: Average LLT (LLTave)
timeFrame: Baseline and one month after 1 month of treatments
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
Study officials:
References: