louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01918085: Human Skin Test Model in Colostomists
Official title: Open, Prospective, Single Centre, Randomized, Controlled, Cross-over. Clinical Study Investigating the Correlation in Peel Force of Standard Hydrocolloid Adhesive and a Standard Strata Adhesive From Peristomal Skin and Pre-stripped Abdominal Skin in Colostomists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colostomy Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2013-08-07
Enrollment: 22
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aim of the study is to investigate the correlation in peel force when peeling off a standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin compared to pre-stripped healthy abdominal skin in colostomists.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent.
2. Be in the age of 45 to 75 years of age both extremes included.
3. Have had a colostomy for at least 1 year.
4. Has a colostomy with a diameter up to (≤) 40 mm.
5. Have mental capacity to understand the study guidelines and questionnaires.
6. Be assessed by the investigator as having a peristomal and abdominal skin condition justifying entry into the investigation.
7. Are colostomists currently using a 1-piece and 2-piece flat ostomy appliance.
8. Have a BMI between 20-30 kg/m2.
9. Are willing to comply with investigation procedures.

Exclusion Criteria:

1. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
2. Received radio- and/or chemotherapy within the last two months.
3. Currently using or have within the last 3 weeks used topical steroid products or other skin prep products.

   on peristomal skin (injections and oral treatment are accepted).
4. Have dermatological problems.
5. Participating in other clinical studies or have previously participated in this test.
6. Be a daily user of a convex base-plate.
7. Are pregnant or breastfeeding.
8. Systemic elements that could affect skin histology (e.g. liver, kidney or immunological diseases).

Primary outcomes:
measure: Peel Force
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bispebjerg Hospital, Denmark
name: Tonny Karlsmark, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05915585: High-Intensity Laser Therapy for Eosinophilic Fasciitis
Official title: Efficacy of High-Intensity Laser Therapy for the Management of Eosinophilic Fasciitis: A Case Report
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eosinophilic Fasciitis
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single participant case study
Primary purpose: TREATMENT

Brief summary: Eosinophilic fasciitis (EF) is a rare musculoskeletal disorder characterized by inflammation and thickening of the fascia, leading to pain, stiffness, and functional impairment. Conventional treatment options include immunosuppressive medications, corticosteroids, and physical therapy. This case report will describe use of high-intensity laser therapy (HILT) using the Mectronic Exand MY high-intensity laser system in a patient with EF, highlighting its potential as an alternative or adjunct treatment option.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Eosinophilic fasciitis.

Exclusion Criteria:

* a diagnosis unrelated to Eosinophilic fasciitis

Primary outcomes:
measure: Pain intensity via Numeric pain rating scale
timeFrame: Changes in pain intensity at baseline and 4 weeks
measure: Functional outcomes via Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
timeFrame: Changes in DASH at baseline and 4 weeks
measure: Quality of life via Short Form-36 Health Survey
timeFrame: Changes in Short Form-36 Health Survey at baseline and 4 weeks
measure: Adverse event
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_DIRECTOR
References:
Clinical trial NCT04984785: Lipid Metabolism in Obese Subjects Undergoing Bariatric Surgery
Official title: Characterization of Physiological Mechanisms Involved in the Regulation of Eating Behavior for the Identification of Innovative Nutritional Strategies for Obese Patients Before and After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Lipid Metabolism Disorders
Obesity
Keywords: Fatty Acids, Nonesterified
Peroxisome Proliferator-Activated Receptors
Endocannabinoids
N-acylethanolamines
Lead sponsor: University of Cagliari
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Brotzu
First posted: 2021-08-02
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for bariatric surgery

Brief summary: The aim of the study is to evaluate modifications in the metabolism of polyunsaturated fatty acids (PUFA) and biosynthesis of the lipid mediators N-acylethanolamines (NAE), both known to induce and be induced by the nuclear peroxisome proliferator-activated receptor (PPAR)-α, which may also explain the well-established improved lipid and energy metabolism after bariatric surgery. The study is focused on understanding the weight loss mechanisms in order to develop targeted dietary protocols.

Detailed description: The study involves a careful preliminary medical history of the patients, with physical examination, anthropometric parameters measurements and blood sampling for blood chemistry routine and evaluation of any adverse events to assess suitability for the study. The evening before bariatric surgery, one month and six months after bariatric surgery anthropometric parameters measurements, blood sampling for blood chemistry routine, inflammatory and lipid-metabolomic profile, and evaluation of any adverse events are performed. For the study samples are stored identified by a code to be analyzed anonymously. Study interruption criteria are: development of allergic reactions, ketonemia\> 1.5 mmol/L, acute gout

Eligibility criteria: Inclusion Criteria:

* subjects with pathological obesity suitable for bariatric surgery
* Body Mass Index (BMI) range 35-59

Exclusion Criteria:

* established diagnoses of a major disease (e.g., diabetes or kidney disease)
* pregnancy or breastfeeding,
* food allergies,
* use of drugs that could affect lipid metabolism

Primary outcomes:
measure: Modifications of Endocannabinoid and N-acylethanolamine plasma levels
timeFrame: 6 months
measure: Weight loss as kg, and fat mass reduction as total kg and percent of body mass
timeFrame: 6 months
measure: Changes in fatty acid plasma profile induced by bariatric surgery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Centro di Chirurgia Bariatrica dell'Azienda Ospedaliera G. Brotzu
Study officials:
affiliation: Università di Cagliari
name: Sebastiano Banni, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06257485: Bronx Transthyretin Amyloid Cardiomyopathy Database
Official title: Database of Transthyretin Amyloid Cardiomyopathy Cases in a Racially and Ethnically Diverse Population in the Bronx
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Transthyretin Cardiac Amyloidosis
Transthyretin Amyloid Cardiomyopathy
Keywords: transthyretin cardiac amyloidosis
transthyretin amyloid cardiomyopathy
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients referred for PYP SPECT at Montefiore Medical Center between 2014 and 2023 who had a transthoracic echocardiogram in our medical records.

Brief summary: Transthyretin amyloid cardiomyopathy (ATTR-CM) is a commonly undiagnosed and potentially fatal disease. Contemporary studies on this condition often underrepresent the female gender and diverse patient populations. This registry retrospectively evaluated patients referred for 99mTc-pyrophosphate (PYP) Single Photon Emission Computed Tomography (SPECT) between 2014 and 2023 at Montefiore-Einstein in the Bronx. The patient population is racially and ethnically diverse and with a high proportion of females. Demographic, clinical (e.g. comorbidities), laboratory, echocardiographic, hospitalization, and mortality data were collected for each patient.


Eligibility criteria: Inclusion Criteria:

* All adult patients referred for PYP SPECT at Montefiore Medical Center between 2014 and 2023

Exclusion Criteria:

* Did not have a transthoracic echocardiogram in our medical records

Primary outcomes:
measure: ATTR-CM Diagnosis
timeFrame: During the index PYP scan within the study time frame parameters of the retrospective review (between 2014 and 2023)
measure: Mortality
timeFrame: Within the study time frame parameters of the retrospective review (between 2014 and 2023)
Secondary outcomes:
measure: Heart failure hospitalizations
timeFrame: Within the study time frame parameters of the retrospective review (between 2014 and 2023)
measure: Total Hospitalizations
timeFrame: Within the study time frame parameters of the retrospective review (between 2014 and 2023)
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Health System
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Leandro Slipczuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06847685: Mechanisms of Uterine Fluid Absorption During Early Pregnancy ( ELF Study)
Official title: Mechanisms of Uterine Fluid Absorption During Early Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis
Endometrioma
Keywords: Endometriosis
Endometrial biopsy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institutes of Health (NIH)
First posted: 2025-02-26
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between the ages of 18-45 with or without endometriosis.

Brief summary: The researchers are evaluating mechanisms of uterine fluid absorption during early pregnancy


Eligibility criteria: Inclusion Criteria:

1. Subject must be a healthy woman between the ages of 18 and 45 years.
2. Women with diagnosed endometriosis or infertility (cases).
3. Women without a diagnosis of endometriosis or infertility (controls).
4. Subject must have regular menstrual cycles.
5. Subject must have a body mass index (BMI) between 18 and 40.
6. Subject must be or have been sexually active or have had a previous vaginal exam that used a speculum.
7. Subject must be able to understand and provide consent to procedures and use/disclosure of protected health information.
8. No history of Chlamydia trachomatis, Mycoplasma genitalium, Neisseria gonorrhoeae, hepatitis B, and HIV.
9. For IVF study subjects, a minimum endometrial thickness of 7mm at the time of sample collection.

Exclusion Criteria:

1. Pregnant women.
2. Study subjects with endometrial cancer.
3. Study subjects with a history of endometrial ablation.
4. Study subjects with undiagnosed uterine bleeding.
5. Women with reproductive diseases that affect the endometrium (such as fibroids or uterine polyps that distort endometrial cavity).
6. Study subjects with an intrauterine device (IUD).

Primary outcomes:
measure: Expression levels of selected ion channels in human endometrium biopsies across the menstrual cycle.
timeFrame: 5 years
Secondary outcomes:
measure: Compare relative protein expression of ENaCα, SLC5A1 and SLC5A3 by immunohistochemistry
timeFrame: 5 years
Other outcomes:
Locations:
city: Athens
country: United States
facility: University of Georgia
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
affiliation: Johns Hopkins University
name: James Segars, MD
role: STUDY_CHAIR
affiliation: Johns Hopkins University
name: Bhuchitra Singh, MD, MPH, MS, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT02666885: Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer
Official title: Personalised Postoperative Radiochemotherapy in Patients With Head and Neck Cancer and Development of a Multi-parametric Decision Support System for Personalised Medicine in Radiation Oncology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Personalized Medicine
Radiation Oncology
Functional Imaging
Biomarker
Decision Support System
Radiomics
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 49
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: The current trial is evaluating the integration of a pretherapeutical FDG-PET/MRI in the adjuvant radiochemotherapy in patients with head and neck cancer. As a secondary hypothesis the intention is to develop of a multi-parametric decision support system for personalised medicine by integrating functional imaging, γH2AX-analysis and genetic information.


Eligibility criteria: Inclusion Criteria:

* locally-advanced HNSCC (Oro- and Hypopharynx) stage III and IV without distant metastases
* no contraindications for PET/MRI
* no contraindications for radiochemotherapy
* informed consent
* ECOG PS 0/2

Exclusion Criteria:

* Secondary malignancies that might influence outcome within 2 years after radiochemotherapy of the HNSCC
* previous PET/CT
* induction therapy
* pregnancy or breastfeeding

Primary outcomes:
measure: locoregional progression free survival
timeFrame: 2 years after primary diagnosis
Secondary outcomes:
measure: Disease free survival
timeFrame: 2 years after primary diagnosis
measure: Overall survival
timeFrame: 2 years after primary diagnosis
measure: Development of a multi-parametric decision support system
timeFrame: after termination of recruitment and follow up up to 5 years
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen, Department of Radiation Oncology
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Tuebingen, Department of Radiation Oncology, Tuebingen, Germany
name: Daniel Zips, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05101785: Articaine 4% Efficacy and Safety in Extraction and Pulpotomy of Primary Molars of Children Below the Age of Four Years
Official title: Articaine 4% Efficacy and Safety in Extraction and Pulpotomy of Primary Molars of Children Below the Age of Four Years.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Behavior
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 292
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: compare the anaesthetic efficacy and safety for pain and behaviour for extraction or pulp therapy in primary molars in young children below four years old using 4% articaine and 2% lidocaine local anesthetics.


Eligibility criteria: Inclusion Criteria:

* Healthy children
* 3-6 years
* primary molar indicated for pulpotomy
* body weight not less than 15 Kg

Exclusion Criteria:

* Intellectual problem
* sever emotional problems
* previous dental experience
* Medically or mentally compromised children

Primary outcomes:
measure: Intra and post operative pain
timeFrame: 30-60 minutes
measure: Behavior
timeFrame: 30-60 minutes
measure: Blood pressure
timeFrame: 30-60 minutes
measure: Heart rate
timeFrame: 30-60 minutes
measure: Respiratory rate measuring during treatment
timeFrame: 30-60 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04247685: Evaluation of MRI-conditional 12-lead ECG
Official title: Evaluation of MRI-conditional 12-lead ECG
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will aim to recruit 2-3 patients per month, with a total of 40 patients over two years. These 40 patients will be assigned into two MRI groups -12-lead ECG gating system as the study group and 3-lead ECG gating system as the control group. The study group patients will have MRI with 12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical, while the control group will have MRI with 3-lead ECG gating which is standard of care. Diagnostic image quality and severity of artifact will be evaluated to compare these two groups.
Primary purpose: OTHER

Brief summary: With MRI's increasing role in detecting central nervous system and orthopedic diseases, patients with ischemic history are increasingly referred for MRI exams. Currently, 3-lead ECG gating systems are utilized during cardiac MRI scanning as standard of care. However, this monitoring system is often insufficient to evaluate for the development of important arrhythmias or ischemia during MRI scanning. Morevoer, MRI associated magnetic fields and radio frequency pulses can produce interference in the ECG signal that leads to non-diagnostic ECG signals. MiRTLE Medical, a Massachusetts-based medical device company, has developed a high-fidelity, MRI-conditional 12-lead ECG monitoring system. This 12-lead ECG system is a first of its kind that addresses the MRI-induced interference and safety issues. This study is to evaluate the efficacy of this 12-lead ECG system in the clinical setting. The investigators hope that this system will be helpful for image-guided therapeutics especially electrophysiology.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Atrial fibrillation
* Provision of informed consent
* Eligible for the Ontario Health Insurance Plan

Exclusion Criteria:

* Failure to provide informed consent
* Pregnant women
* CMR contra-indicated
* Hemodynamically unstable
* Permanent pacemaker/ICD
* Aneurysm clip/carotid artery vascular clamp
* Claustrophobic

Primary outcomes:
measure: absolute numbers and percentages
timeFrame: up to 6 weeks
measure: qualitatively comparison with a standard scale
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
Study officials:
References:
Clinical trial NCT01032785: Timing of Closure of Patent Foramen Ovale Following Birth
Official title: Timing of Closure of Patent Foramen Ovale and Patent Ductus Arteriosus Following Birth
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Closure of the Foramen Ovale and Ductus Arteriosus
Keywords: Patent Foramen Ovale
Patent Ductus Arteriosus
PFO
PDA
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population consits of newborn babies born in term and under normal delivery in Wolfson M.C.

Brief summary: It is known that the foramen ovale closes in most infants during the first 6 months of life, however, most of the important papers in the field concentrated on observing infants with murmurs and following those with patent foramen ovale by echocardiography until 6-24 months. The purpose of this study is to observe the natural profile of closure of the foramen ovale and ductus arteriosus for the first 36 hours after birth. This understanding may help to avoid unnecessary treatment and exams for newborns with findings that are natural for their stage of development.

Detailed description: We will observe the patency and size of foramen ovale five times within the first 36 hours of life. We will also describe the anatomy of the foramen ovale and the septum primum during this time. The direction of flow across the foramen ovale will also be observed. Other cardiac lesions will be checked for as well. We will measure the change in size of the pulmonary arteries and the closure of the ductus arteriosus.

Eligibility criteria: Inclusion Criteria:

* any baby born in term and with normal delivery

Exclusion Criteria:

* sick newborns in need of neonatal intensive care for any medical reason.
* newborns with congenital heart disease except for small, muscular ventricular septal defects

Primary outcomes:
measure: Patent Foramen Ovale size using 2 echocardiography positions, shunt direction and distance of septum primum to Superior Vena Cava
timeFrame: 2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours and 36 hours
Secondary outcomes:
measure: Patent Ductus Arteriosus size, shunt direction and the size of the Left Pulmonary Artery, the Right Pulmonary Artery and the Pulmonary Annulus
timeFrame: 2-3 hours after birth, 5-6 hours, 7-8 hours, 12-13 hours, 36 hours
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson Medical Center
Study officials:
affiliation: Tel Aviv University
name: Akiva Tamir, M.D
role: PRINCIPAL_INVESTIGATOR
References: