louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06994208: Characteristics of Adult Patients With Melanoma Diagnosis <40 Years Age.
Official title: Demographic, Clinical, Dermoscopic, Phenotypic and Genetic Characteristics of Adult Patients With Melanoma Diagnosis <40 Years Age. A Prospective, Monocentric Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Melanoma of Skin
Lead sponsor: Ente Ospedaliero Ospedali Galliera
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Since there are no epidemiological data about the prevalence of melanoma in subjects aged 18-39 years, there are very few data available on risk factors in this age group and the impact of the disease.

The present study, therefore, will enroll about 25 patients who will attend the Dermatology Unit and who have a histological diagnosis of cutaneous melanoma in a period of 24 months of observation.

Brief summary: The primary objective of the study is to analyse a local cohort of patients aged 18-39 years with melanoma diagnosis in order to determine the prevalence of the disease in this age group.

Secondary objectives are the following:

* To identify risk factors associated with melanoma in young people.
* To characterise the phenotype and dermoscopic features of melanoma in patients aged 18-39 years.
* To analyse the relationship between the clinical and histopathological features of melanoma in young people.
* To identify the mutational status of B-RAF in the sample of patients analysed.


Eligibility criteria: Inclusion Criteria:

1. written informed consent
2. age \> 18 years and \< 40 years
3. diagnosis of cutaneous melanoma even non-primary

Exclusion Criteria:

-

Primary outcomes:
measure: Melanoma prevalence
timeFrame: 3 years
Secondary outcomes:
measure: Risk factor
timeFrame: 3 years
measure: Melanoma phenotype
timeFrame: 3 years
measure: Histopathological feature
timeFrame: 3 years
measure: Mutational status
timeFrame: 3 years
measure: Dermoscopy of melanoma
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Ente Ospedaliero Ospedali Galliera
name: Sanja Javor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03999008: Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA)
Official title: A Multicentre, Prospective, Randomized, Placebo Controlled, Double-blinded Study to Demonstrate Potential and Beneficial Effects of Oral Viscous Budesonide (OVB) in the Prevention of Recurrence of Anastomotic Stricture in Children Operated on for Esophageal Atresia With Recurrent Anastomotic Strictures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Atresia
Anastomotic Stenosis
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to perform a multicentre, prospective, randomized, placebo controlled, double-blinded study to demonstrate the potential and beneficial effects of OVB in the prevention of recurrence of anastomotic stricture in children operated for esophageal atresia with an anastomotic stricture.


Eligibility criteria: Inclusion Criteria:

* Children aged \> 1 month to 3 years
* Operated for an esophageal atresia of all types except pure TEF.
* Presence of an anastomotic stricture defined according to experts recommendations :

  * a relative esophageal narrowing at the level of the anastomosis,
  * demonstrated by a contrast study and/or an endoscopy
  * with significant functional impairment and associated symptoms requiring dilation.
  * Symptoms include: feeding or swallowing difficulties, coughing and choking during feeds, food impaction, regurgitation/vomiting of undigested food, drooling. In very young patients: apnea and food refusal.
* Receiving an ongoing treatment by PPI 1 to 2 mg/kg die
* Informed parental consent

Exclusion Criteria:

* Known immune deficiency
* Acute respiratory or intestinal infection
* Severe respiratory, cardiac or neurological condition precluding OVB or placebo swallowing
* Child fed exclusively via nasogastric tube or gastrostomy
* Absence of parental consent

Primary outcomes:
measure: number of dilations needed after randomization (beginning of treatment)
timeFrame: 12 months
Secondary outcomes:
measure: Number of patients needing dilation after randomization (beginning of treatment)
timeFrame: 12 months
measure: Number of patients needing more than 3 dilations after randomization
timeFrame: 12 months
measure: Mean time to further dilation
timeFrame: 12 months
measure: Number of patients treated with an adjuvant therapy
timeFrame: 12 months
measure: Ability to tolerate normal food for age
timeFrame: 12 months
measure: Dysphagia score
timeFrame: 12 months
measure: Quantification of the anastomostic stricture by the Stricture index (SI) calculated on barium swallow at 12 months of age
timeFrame: 12 months
measure: Side effects/Adverse events
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03729908: Animal Assisted Mindfulness Intervention (AAMI) for Patients With Acquired Brain Injury
Official title: Effects of an Animal Assisted Mindfulness Intervention for Patients With Acquired Brain Injury: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Rehab Basel
name: University of Basel
name: University of Bern
First posted: 2018-11-05
Enrollment: 31
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 aim of this study is to investigate the effect of an animal assisted mindfulness intervention (AAMI) on patients with acquired brain injuries on their global severity of psychological distress.

In addition, the effects on the patients' symptoms of depression, anxiety, perceived stress, mood, coping and mindfulness/self-compassion will be assessed.

The study experimental condition consists of 6 weeks of intervention, containing 6 different modules. In every session, an animal will be present.

In the control condition, the same program and same exercises will be used without the presence of or reference to animals. Sessions take place two times a week for 6 weeks (leading up to a total of 12 experimental/control sessions), each lasting for about 60 minutes.

24 participants are planned to be included, 12 patients in each group.

Detailed description: It was estimated that a total sample of 24 participants (12 patients in each group) would provide enough power to detect a medium effect. Since we had several dropouts, two additional groups (one intervention and one control) were started. This lead to the inclusion of 31 participants with a total sample size of 25 participants finishing the program.

Eligibility criteria: Inclusion Criteria:

* Patients of REHAB Basel
* Acquired Brain Injury (ABI); FIM (Functional Independence Measure) cut-off score defined as \> 60
* Depressive or/and anxiety symptoms
* Psychological difficulties coping with the actual life situation
* 18 years or older
* Willing to work with therapy animals
* German speaking
* Willingness to participate/informed consent

Exclusion Criteria:

* Communication and articulation is not possible
* Allergy to animals
* Aversion against animals
* Schizophrenic-related comorbidity
* Mobilization to "Therapietiergarten" not possible

Primary outcomes:
measure: General psychological distress
timeFrame: 11 weeks
Secondary outcomes:
measure: Depression
timeFrame: 11 weeks
measure: Perceived Stress
timeFrame: 11 weeks
measure: Mindfulness
timeFrame: 11 weeks
measure: Self-compassion
timeFrame: 11 weeks
measure: Coping
timeFrame: 11 weeks
measure: Visual Analogue Scale (VAS)
timeFrame: 11 weeks
measure: Mood
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: REHAB Basel
state: BS
Study officials:
affiliation: University of Basel
name: Karin Hediger
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06289608: Bruxism and Underlying Psichological Factors
Official title: Bruxism and Underlying Psichological Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bruxism
Muscular Disorders, Atrophic
Temporomandibular Joint Disorders
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Self-reported bruxists

Brief summary: The aim of this study was o determine the relationship between self-reported bruxism (SB) and some psychological factors (i.e: Anxiety State-Trait; Stress Reactivity Index, Beck Depression Inventory). A consecutive sample of 101 patients that reported at least 2 of the 6 items of Bruxism self-reported index, were explored clinically for quantifying the number and severity of worn teeth, and also the severe and location of the muscular pain according to an standardized inventory.

Detailed description: The Bruxism Self-Reported Index was that reported by Pintado et al.

Pintado MR, Anderson GC, DeLong R, Douglas WH. Variation in tooth wear in young adults over a two-year period. J Prosthet Dent. 1997;77:313-320.

The muscular pain was assessed by the last version of the Research Diagnostic Criteria reported by the Schiffman et al in 2014

Schiffman E, et al ; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network\* and Orofacial Pain Special Interest Group†. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27.

Eligibility criteria: Inclusion Criteria:

* Self-reported Bruxism

Exclusion Criteria:

* Refused patients

Primary outcomes:
measure: Depression Level
timeFrame: baseline
measure: Stress Level
timeFrame: baseline
measure: Anxiety
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Clinica Odontológica de la Universidad de Salamanca
Study officials:
References:
Clinical trial NCT00323908: Protocol to Examine Methylation of Tumor Suppression Genes in Women at High Risk of Developing Breast Cancer
Official title: QM-MSP, Ki-67, and Cytomorphology of RPFNA Specimens From High Risk Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
prevention
tissue sampling
polymorphisms
steroid and carcinogen metabolism
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: Avon Foundation
name: National Cancer Institute (NCI)
name: Johns Hopkins University
First posted: 2006-05-10
Enrollment: 281
Sex: FEMALE
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: medical center

Brief summary: A study to examine the correlations between methylation of various genes associated with breast cancer and proliferation and cytomorphology in breast epithelial cells acquired by random periareolar fine needle aspiration of women at high risk for development of breast cancer.

Detailed description: A study to examine the correlation between gene promotor methylation and benign breast tissue proliferation and cytomorphology collected via random periareolar fine needle aspiration in postmenopausal women at increased risk for breast cancer.

Eligibility criteria: Inclusion criteria:

* women at high risk of developing breast cancer determined by family or personal history
* willing to participate in companion protocol (KUMC HSC#4601) for random periareolar fine needle aspiration (RPFNA) for correlational studies

Exclusion criteria:

* exclude women who have been on raloxifene, tamoxifen, letrozole, anastrozole or exemestane within the six months prior to RPFNA

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Kansas Medical Center
name: Carol J Fabian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03521908: A Study to Compare the Risk of a Major Bleeding in Participants Who Received Blood Thinning Medications Following a Blood Clot
Official title: Risk of Major Bleeding Associated With Apixaban Verses Warfarin in the Treatment of Venous Thromboembolism in US Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism (VTE)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-05-11
Enrollment: 35756
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will comprise all persons aged ≥18 years who received outpatient treatment with apixaban or warfarin within 30 days following their first observed encounter for VTE, and who met all other qualifying criteria.

Brief summary: A study to compare the risk of a major bleeding in participants who received 2 different blood thinning medications following a blood clot


Eligibility criteria: Inclusion Criteria:

* An acute-care inpatient encounter with a principal or secondarydiagnosis of VTE, or an ambulatory-care encounter with any diagnosis of VTE
* An outpatient pharmacy claim for apixaban or warfarin during the 30-day period following the index encounter
* Continuous and comprehensive medical/drug coverage for ≥6 months preceding the index encounter

Exclusion Criteria:

* Evidence of a trial fibrillation/flutter or chemotherapy/radiation therapy for malignancy (other than non-melanoma skin cancer) during 6-month period preceding first receipt of index therapy
* Evidence of VTE(VTE event)during 6-month period preceding index encounter
* Evidence of malignancy (other than non-melanoma skin cancer) during 90-day period preceding first receipt of index therapy

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Incidence of major bleeding in participants treated with apixaban
timeFrame: 2 years
measure: Incidence of major bleeding in participants treated with warfarin
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of clinically relevant non-major bleeding event in participants treated with apixaban
timeFrame: 2 years
measure: Incidence of clinically relevant non-major bleeding event in participants treated with warfarin
timeFrame: 2 years
measure: Incidence of recurrent VTE in participants treated with apixaban
timeFrame: 2 years
measure: Incidence of recurrent VTE in participants treated with warfarin
timeFrame: 2 years
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02340650: High Resolution Imaging for Early and Better Detection of Bladder Cancer
Official title: High Resolution Imaging for Early and Better Detection of Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: suspicious bladder lesion, normal bladder tissue
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: William Marsh Rice University
First posted: 2015-01-16
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential subjects will be identified from patients who are visiting Lyndon B. Johnson Hospital (LBJ) Houston for evaluation of bladder cancer or a suspicious bladder lesion/clinical symptomatology by cystoscopy and bladder biopsy or from LBJ patients who are undergoing cystoscopy as part of their routine clinical care.

Brief summary: The goal of this study is to develop, optimize, and validate a High Resolution Imaging System in the bladder that displays images in real-time, providing automated diagnostic criteria for bladder cancer screening. High resolution images of normal bladder tissue and suspicious bladder lesions will be collected from patients who present to the study site for clinical evaluation.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with clinically suspicious bladder lesion or clinical finding; or who are undergoing cystoscopy as part of their routine clinical care.
* Must be willing and able to participate and provide written informed consent
* Women of childbearing age who have the possibility of being pregnant must have a negative pregnancy test prior to participation

Exclusion Criteria:

* Patient with sufficient evidence of cognitive impairment that limits the subject's ability to understand the protocol, provide informed consent, or to comply with the protocol procedures.
* Women with the possibility of having the pregnancy.
* Patients having acute infection.
* Person with Lidocaine sensitivity.

Primary outcomes:
measure: Specificity of Bladder Cancer Detection Imaging
timeFrame: baseline (at the time of imaging)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B. Johnson General Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nadeem N Dhanani, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tang Y, Kortum A, Vohra I, Schwarz RA, Carns J, Kannady CR, Clavell-Hernandez J, Hu Z, Dhanani N, Richards-Kortum R. Initial Results of First In Vivo Imaging of Bladder Lesions Using a High-Resolution Confocal Microendoscope. J Endourol. 2021 Aug;35(8):1190-1197. doi: 10.1089/end.2020.0757. Epub 2021 Jan 21.
Clinical trial NCT04640350: Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography
Official title: Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Gastroesophageal Varices
Variceal Hemorrhage
Keywords: Elasticity Imaging Techniques
Ultrasound
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with liver cirrhosis and the gastroscopy is in line with the indications of portal hypertension.

Brief summary: Through the parameters of liver stiffness and spleen stiffness obtained by combi-elastography technique, summarize and analyze the warning index of esophagogastric variceal bleeding in patients with cirrhosis, so as to provide a new and valuable technique for clinical diagnosis.

Detailed description: Firstly,the combi-elastography technique developed by HITACHI uses the method of multi-index and multi-parameter to evaluate the liver stiffness and spleen stiffness comprehensively.

And then,this prospective study is designed to follow up patients with cirrhosis for a period of 12 months, summarize and analyze the warning index of bleeding in patients with cirrhosis,so as to provide a new and valuable technique for clinical diagnosis.

Eligibility criteria: Inclusion Criteria:

* 18-80 years old, no gender limit;
* The clinical diagnosis is in line with patients with liver cirrhosis caused by chronic hepatitis B, and the gastroscopy is in line with the indications of portal hypertension;
* Gastroscopy needs to provide the degree of gastroesophageal varices;
* Sign the informed consent form.

Exclusion Criteria:

* Patients with cirrhosis and portal hypertension because of other causes or combined with other causes(such as viral hepatitis other than hepatitis B,Autoimmune liver disease, alcoholic liver disease, metabolism-related fatty liver disease, etc.)
* Patients with a history of spleen-related operations, such as splenectomy, splenic embolism;
* Patients undergoing portosystemic shunt or TIPS;
* Isolated esophageal venous tumor and its bleeding patients;
* History of upper gastrointestinal tumor or bleeding from gastric ulcer , etc;
* Those with serious diseases of other systems that cannot cooperate with elastography examination, such as heart failure, renal failure, mental illness, etc;
* Ascites before liver and spleen result unable to complete elasticity examination;
* Pregnant patients.

Primary outcomes:
measure: F index
timeFrame: baseline
measure: A index
timeFrame: baseline
measure: Spleen stiffness
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Ping Liang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03058250: Trial Comparing Routine Intraoperative Transesophageal Echocardiography During Radical Cystectomy to Standard of Care
Official title: Randomized Control Trial Comparing Routine Intraoperative Transesophageal Echocardiography During Radical Cystectomy to Standard of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac and Pulmonary Complications. Central Venous Line Insertion. Gastrointestinal Recovery
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective randomized controlled trial looking at the utility of intraoperative transesophageal echocardiography (TEE) on clinical outcomes after radical cystectomy. Patients in the control group will have standard of care, patients in the TEE group will have standard of care and TEE monitoring throughout. Intraoperative and postoperative variables, such time to extubation, postoperative cardiac and pulmonary complications, intraoperative fluid and vasopressor use will be assessed.


Eligibility criteria: Inclusion Criteria:

* Adult patients have elective radical cystectomy at The University of Chicago Hospital.

Exclusion Criteria:

* Patient refusal, emergent surgery, preoperative mechanical ventilation, preoperative hemodynamic instability (intravenous vasopressor support), and/or esophageal/gastric pathology contraindicating insertion of the transesophageal echocardiography probe.

Primary outcomes:
measure: Incidence of intraoperative central venous line insertion
timeFrame: 1 day after study enrollment
measure: postoperative return of bowel function via flatus or passage of stool
timeFrame: 5 days after study enrollment
Secondary outcomes:
measure: Decreased postoperative pulmonary and cardiac complications
timeFrame: approximately 5-7 days
Other outcomes:
Locations:
Study officials:
References: