louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06324149: Age-related Conditions in the Context of Multimorbidity and Frailty: Relative Weight of Frailty in Determining the Course and Outcomes of Different Chronic Diseases and Viceversa
Official title: Age-related Conditions in the Context of Multimorbidity and Frailty: Relative Weight of Frailty in Determining the Course and Outcomes of Different Chronic Diseases and Viceversa
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Frailty
Sarcopenia
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 1250 individuals of the FRASNET study (original promoter of the study Ospedale San Raffaele, Principal Investigator Professor Paolo Manunta): older volunteers who were either robust or frail at the evaluations performed in 2016-2017 )
* 720 patients suffering from cognitive impairment and clinically followed at the Neurology Department of the San Raffaele Hospital (UniSR Prof Agosta)

Brief summary: Observational study. Participants of the FRASNET study (9th March 2017, Protocol No. 24/INT/2017) who were evaluated in 2016 and 2017 will be contacted to be re-evaluated with multidimensional visits as part of the present study in order to assess trajectories and biomarkers of frailty and sarcopenia. Moreover, are going to evaluate with the same multidimensional visits patients with mild cognitive impairment and dementia followed up at the Neurologic Unit of the San Raffaele Hospital.


Eligibility criteria: Inclusion Criteria:

* Having participated in the FRASNET study or being a patient with mild cognitive impairment or dementia followed up at the Neurologic Unit of the San Raffaele Hospital
* Ability to sign written informed consent
* \> 18 years old

Exclusion Criteria:

* Life expectancy \< 6 months
* Unwillingness to participate in the study
* Unstable clinical disease(for ex. serious acute pathologies)

Primary outcomes:
measure: identify new molecular markers of frailty and sarcopenia
timeFrame: febbrary 2026
Secondary outcomes:
measure: evaluate the ability of new markers for frailty, sarcopenia, cognitive impairment
timeFrame: april 2026
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital
Study officials:
References:
Clinical trial NCT06276049: ChatGPT Helping Advance Training for Medical Students: A Study on Self-Directed Learning Enhancement
Official title: Enhancement of Self-Directed Learning Through Custom GPT's AI Facilitation Among Medical Students: A Open-label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-Directed Learning
Artificial Intelligence
Medical Education
Keywords: self-directed learning
Artificial Intelligence
Medical Education
ChatGPT
large language model
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: Central South University
First posted: 2024-02-23
Enrollment: 103
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to evaluate the effect of LearnGuide, a custom GPT developed with ChatGPT for supporting self-directed learning (SDL) in medical students. The main questions it aims to answer are:

How does LearnGuide influence SDL skills among medical students? Can LearnGuide improve critical thinking and learning flow as measured by Cornell Critical Thinking Test (CCTT) Level Z score and Global Flow Score (GFS)?

Participants will:

Undergo a two-hour introduction to LearnGuide. Engage in 12 weeks of SDL task-based training with LearnGuide\&amp;#39;s support.

If there is a comparison group: Researchers will compare the group utilizing LearnGuide for SDL and the group without this tool to see if there is a significant difference in SDL skills, critical thinking, and learning flow experiences.


Eligibility criteria: Inclusion Criteria:

* Undergraduate and postgraduate students studying at the Second Xiangya Hospital
* with access to ChatGPT

Exclusion Criteria:

* utilization of large language models for learning assistance more than once weekly for a period exceeding 2 months.

Primary outcomes:
measure: Self-Directed Learning Scale
timeFrame: at 6 ，12 and 14 weeks
Secondary outcomes:
measure: Cornell Critical Thinking Test (CCTT) Level Z
timeFrame: at 6 ，12 and 14 weeks
measure: Flow Short Scale
timeFrame: at 6 and 12 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: Department of Geriatirc Surgery
state: Hunan
Study officials:
References:
Clinical trial NCT00496249: The Effect of Radiation on Semen Quality and Fertility in Men With Prostate Cancer
Official title: The Effect of Radiation on Semen Quality and Fertility in Men Treated With External Beam Radiation or Brachytherapy for Early Stage Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate
cancer
brachytherapy
radiation
semen
fertility
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2007-07-04
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men being treated with radiation therapy for localized prostate cancer who consent to participate and provide a semen specimen for analysis following thereapy.

Brief summary: Many younger men are diagnosed with prostate cancer. These patients are often choosing radiation therapy as their primary treatment. The effect of this therapy on fertility will have a direct impact on their decision about therapeutic options and fertility preservation. The researchers hypothesize that when patients are treated with radiation for localized prostate cancer, infertility can occur due to direct damage to seminiferous tubules affecting sperm quality.

Detailed description: Prostate cancer is the most common malignant disease among men. Many young men are diagnosed with localized prostate cancer. Some of these men are choosing to manage their prostate cancer with radiation therapy. The radiation therapy delivers minimal dose exposure to adjacent organs. We hypothesize that when patients are treated with radiation therapy for localized prostate cancer, decreased fertility can occur due to damage of seminiferous tubules, which may affect sperm quality. This study will assess the impact of radiation therapy on semen and seminal fluid.

Eligibility criteria: Inclusion Criteria:

* Subjects with histologically confirmed low risk to moderate stage prostate cancer (Gleason 6 - 7) treated with brachytherapy or external beam radiation
* \> 12 months ago

Exclusion Criteria:

* Subjects with a prior history of infertility
* Subjects who have undergone vasectomy
* Subjects who have received LHRH therapy for prostate cancer \< 6 months ago
* Subjects who have received anti-androgens \< 3 months ago
* Subjects using alpha blockers within 7 days of specimen provision
* Subjects who have taken finasteride or dutasteride within the previous 4 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Neil Fleshner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04771949: Prevalence and Environmental Risk Indicators for Periodontitis. A Cross-sectional Study
Official title: Prevalence and Environmental Risk Indicators for Periodontitis. A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontal Diseases
Periodontitis
Lifestyle
Mediterranean Diet
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients coming to the dental University clinic will be screened for the inclusion in the study

Brief summary: Periodontitis is a biofilm-mediated chronic inflammatory disease with a multi-factorial etiology; it belongs to the group of diseases classified as "Non-communicable Diseases" (NCDs). According to the results of the Global Burden of Disease Study of 2017, it is the sixth most prevalent disease worldwide and it constitutes a heavy burden on health costs.

Risk factors for such disease include non-modifiable risk factors, i.e. familiarity, diabetes, cardiovascular diseases, metabolic syndrome, as well as modifiable risk factors, i.e. diet, stress and low physical exercise. Given the significant impact of oral health on the quality of life and overall well being of the individual, many studies investigated the importance of risk factors for oral health. In particular, there is some evidence that more severe manifestations of periodontitis are associated with lower physical activity (De Oliveira Ferreira et al., 2019), poor sleep quality (Karaaslan \& Dikilitaş, 2019) and more perceived stress (Coelho et al., 2020). With regards to diet, despite the high number of studies demonstrating an anti-inflammatory effect of the Mediterranean Diet, no study has ever investigated the adherence to Mediterranean Dieta to the oral health status.

From a methodological standpoint, investigations regarding environmental factors are mainly carried out through questionnaires administration, whose validity and reproducibility had been previously demonstrated. The novelty introduced by the present study would be a complete analysis of the effects of lifestyles (diet, sleep quality, physical exercise, perceived stress) on the periodontal status of the individual.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 70 years old;
* ability and willingness to give informed consent.

Exclusion Criteria:

* pregnancy or lactation;
* inability to communicate either in English or Italian;
* inability or unwillingness to give informed consent.

Primary outcomes:
measure: Prevalence of periodontitis
timeFrame: Baseline
Secondary outcomes:
measure: Adherence to mediterranean diet
timeFrame: Baseline
measure: Sleep Quality
timeFrame: Baseline
measure: Physical Activity
timeFrame: Baseline
measure: Italian Perceived Stress Scale (IPSS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Siena
country: Italy
facility: AOUS
Study officials:
References:
Clinical trial NCT04437849: Home Telemonitoring System for Patients With Heart Failure vs Usual Care
Official title: Trial Clínico: Utilidad Del Telemonitoreo en Pacientes Con IC Como Medio de Apoyo Para la autogestión de la Enfermedad
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Universidad Nacional de Tucuman
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled clinical trial compares a home telemonitoring system (HTS) versus usual care during a 90 days follow-up period of Heart Failure (HF) ambulatory patients, in order to evaluate if the use of the HTS improves quality of life and HF related-knowledge. The study was reviewed and approved by the Methodological Committee and by the Research Ethics Committee from the Provincial Health System, according to the Declaration of Helsinki. Written informed consent was obtained before randomization.


Eligibility criteria: Inclusion Criteria:

* were over 18 years with a primary diagnosis of HF,
* had been hospitalized at least once time as a consequence of a HF decompensation,
* had a Smartphone,
* had access to WiFi,
* had access to a weight scale and to a blood-pressure monitor

Exclusion Criteria:

* illiterate patients,
* had learning difficulties,
* had a cognitive impairment sufficient to interfere with the use of the telemonitoring system, or had a severe depression that could interfere with their quality of life perception.

Primary outcomes:
measure: Changes in quality of life through the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
timeFrame: 3-month
measure: Changes in HF related knowledge through the Knowledge of CHF questionnaire
timeFrame: 3-month
Secondary outcomes:
Other outcomes:
Locations:
city: San Miguel de Tucuman
country: Argentina
facility: Zenón Santillán Health Center Hospital
state: Tucuman
Study officials:
References:
Clinical trial NCT02158949: Study of Mobile Phone Delivered Intervention to Reduce Alcohol Consumption
Official title: Mobilizing to Reduce Overuse of Alcohol in Emergency Department Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Keywords: alcohol
mHealth
SBIRT
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2014-06-09
Enrollment: 48
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: In this study, the investigators will be developing and testing a mobile phone text message intervention to reduce alcohol use for people at risk of alcohol dependence. The investigators hypothesize that this intervention will be acceptable to participants, and that they will stay in the intervention until it's one week completion.


Eligibility criteria: Inclusion Criteria:

* AUDIT score 15-20
* have a mobile phone capable of receiving text messages

Exclusion Criteria:

* age \<18
* unable to consent
* language other than English or Spanish

Primary outcomes:
measure: Acceptability of Intervention to Patient
timeFrame: 1 week
Secondary outcomes:
measure: Number of Participants Completed Assessment at 1 Month
timeFrame: 1 month
measure: Change in Days Drinking Alcohol
timeFrame: 1 month
measure: Change in Days Drinking Heavily in 30 Days
timeFrame: 1 month
measure: Change in Motivation to Change Score
timeFrame: 1 month
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LAC+USC Medicine Center Emergency Department
state: California
Study officials:
affiliation: University of Southern California
name: Elizabeth Burner, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burner E, Zhang M, Terp S, Ford Bench K, Lee J, Lam CN, Torres JR, Menchine M, Arora S. Feasibility and Acceptability of a Text Message-Based Intervention to Reduce Overuse of Alcohol in Emergency Department Patients: Controlled Proof-of-Concept Trial. JMIR Mhealth Uhealth. 2020 Jun 4;8(6):e17557. doi: 10.2196/17557.
Clinical trial NCT02376049: A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)
Official title: An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults With Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Eczema
AD
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-03-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults with Mild to Moderate Atopic Dermatitis.

Detailed description: Multi-center, prospective, randomized, vehicle-controlled, investigator-blinded, stable lesion design.

Eligibility criteria: Inclusion Criteria:

* Subject with mild to moderate AD
* Four comparable TAs
* TSS of at least 5 on all TAs
* Difference in TSS not greater than 2 between the TAs
* Sign score erythema ≥ 2 between the TAs
* TAs should be at least 2 cm apart

Exclusion Criteria:

* Investigator's opinion
* Fitzpatrick skin type \>5
* Topical (i.e. on the TAs) treatment with prohibited medications
* Systemic treatment with prohibited medications
* Phototherapy within prohibited timeframe
* Use of emollients within prohibited timeframe

Primary outcomes:
measure: Total Sign Score (TSS) change
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Netanya
country: Israel
facility: Beit Harofim
Study officials:
affiliation: Icahn School of Medicine
name: Emma Guttmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02270749: Vitamin Deficiencies and Suppletion in Morbid Obesity
Official title: Vitamin Deficiencies and Suppletion in Morbid Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin B12 Deficiency
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the most effective treatment for patients who underwent a Roux-en-Y gastric bypass and developed postoperatively a vitamin B12 deficiency.

Detailed description: Vitamin B12 deficiency accounts up to 23-64% bariatric surgery. The investigators purpose is to evaluate the most effective treatment for vitamin B12 deficiency in patients who underwent a Roux-en-Y gastric bypass.

Daily oral use of vitamin B12 tablets are may be as effective as vitamin B12 injections.

Eligibility criteria: Inclusion Criteria:

* Vitamin B12 deficiency: \<200 pmol/l
* Vitamin B12 deficiency 6-12 months after surgery
* All patients underwent a Roux-en-Y gastric bypass

Exclusion Criteria:

1. Creatin \>150micromol/L
2. Liver enzymes \>2 times upper limit
3. Other bariatric operations
4. Intercurrent diseases
5. Gastro-intestinal diseases
6. Psychiatric disease
7. Medicines which influences bone density
8. Pregnancy

Primary outcomes:
measure: reduction in patients with vitamin B12 deficiency
timeFrame: 6 months after initiating therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate hospital
Study officials:
References:
citation: Schijns W, Homan J, van der Meer L, Janssen IM, van Laarhoven CJ, Berends FJ, Aarts EO. Efficacy of oral compared with intramuscular vitamin B-12 supplementation after Roux-en-Y gastric bypass: a randomized controlled trial. Am J Clin Nutr. 2018 Jul 1;108(1):6-12. doi: 10.1093/ajcn/nqy072.
Clinical trial NCT00829049: Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-01-26
Enrollment: 165
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris


Eligibility criteria: Inclusion Criteria:

* Facial acne vulgaris characterized by the following: 25-100 facial inflammatory lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or less facial nodules and/or cysts (diameter of 1cm or greater).
* Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice reliable method of contraception throughout the study.

Exclusion Criteria:

* Non-compliance with washout period
* Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris
* Allergy or sensitivity to any component of the test medications
* Cosmetic or surgical procedure complementary to the treatment of facial acne within 14 days of the baseline visit

Primary outcomes:
measure: Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16
timeFrame: Week 16
measure: Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12
timeFrame: Week 12
measure: Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Fremont
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06643949: Italian Multicenter Observational Registry on Takostubo Syndrome
Official title: Takotsubo Italian Network: Italian Multicenter Observational Registry on Takostubo Syndrome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Takotsubo Syndrome
Keywords: takotsubo
cardiomyopathy
cardiogenic shock
LVOTO
mitral regurgitation
heart failure
Lead sponsor: University of Molise
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with takotsubo syndrome.

Brief summary: Takotsubo syndrome (TTS) has recently been described as an acquired form of cardiomyopathy whose pathophysiology is not yet well understood and mainly affects postmenopausal women. TTS or "broken heart" syndrome was first described in Japan in 1991. The Japanese term "tako-tsubo" means "polyp vessel" and describes the morphology of the left ventricular apex during systole in patients with this condition. The onset usually follows physical or emotional stress and mimics that of acute coronary syndrome (ACS) with a parade of symptoms, including chest pain, dyspnea, syncope, and nausea. Objective examination is often normal or otherwise nonspecific. ECG may document ST-T changes while echocardiogram shows areas of altered ventricular kinetics. Serum cardiac biomarkers may be increased. Currently, the gold standard method for the diagnosis of TTS is coronarography, which documents epicardial coronary arteries that are normal or free of critical lesions.

It is estimated that more than 2.5% of patients with a suspected diagnosis of ACS have TTS, and this number is probably underestimated. Although the prognosis of TTS is generally considered favorable, during the acute phase these patients can develop potentially fatal complications such as ventricular arrhythmias, cardiogenic shock, and heart rupture. Moreover, emerging scientific evidence sheds light on the need to adopt a dedicated diagnostic-therapeutic pathway for this type of patients.

The exact pathophysiology of TTS is still unknown and no large population studies or registries are currently available. Therefore, the purpose of the study is to better characterize the profile of this disease through the creation of a large registry.


Eligibility criteria: Inclusion Criteria:

Patients diagnosed with TTS in accordance with the InterTAK Diagnostic Criteria.

Exclusion Criteria:

* Age less than 18 years
* Myocarditis
* Acute coronary syndrome
* Myocardial infarction with non obstructive coronary arteries (MINOCA)

Primary outcomes:
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: