louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07023796: Autologous Fat Infiltration Versus General Measures as Treatment in Radiodermatitis Induced for Radiotherapy in Breast Cancer Patients
Official title: Comparison of the Efficacy Between Autologous Fat Infiltration and Treatment With General Measures in the Management of Radiotherapy-induced Radiodermatitis in Breast Cancer Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Radio Dermatitis
Radiotherapy
Keywords: Autologus Fat Filtration
Radiodermatitis
Breast cancer
Nanofat
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2025-06-17
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Radiodermatitis is a major problem in oncologic patients, fat grafts previously used for cosmetic procedures have been shown to have regenerative power due to their stem cell content. Our purpose was to compare the clinical changes in the treatment of radiation dermatitis in breast cancer patients with the application of fat graft versus traditional therapy with general measures.A randomized controlled clinical trial was performed, 22 patients were recruited and randomly assigned to one of two groups: an intervention group that received an autologous fat graft and a control group that received treatment with general measures; a 6-week follow-up was performed to determine the presence and classification of radiodermatitis using the LENT/SOMA scales, as well as biopsies. Women were included, with a diagnosis of breast cancer, Eastern Cooperative Oncology Group 0 or 1, attended in our hospital during September 2023 to October 2024, older than 18 years, undergoing lumpectomy or mastectomy and in radiotherapy as part of the treatment scheme for breast cancer.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years with a confirmed diagnosis of common bile duct cyst by imaging studies and/or intraoperative findings.
* Patients who received surgical treatment at the institution during the study period.
* Clinical records with complete information for analysis.

Exclusion Criteria:

* Patients who do not consent to their inclusion in the study or who for any physical or mental reason are unable to give their consent (patients with cognitive impairment, etc.).
* Pediatric patients (\<18 years).
* Incomplete clinical records or with loss of postoperative follow-up.
* Patients with diagnosis of other biliary pathology without evidence of common bile duct cyst.

Primary outcomes:
measure: Number of patients with radiodermatitis
timeFrame: From the start to six week later
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Belisario Dominguez 1000
state: Jalisco
Study officials:
References:
Clinical trial NCT03581396: Scleral Hydrops and Intralabyrinthine Schwannoma
Official title: Scleral Hydrops and Intralabyrinthine Schwannoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hydrops Saccular
Keywords: Hydrops sacculaire
schwannoma intralabyrinth
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 30
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: Patients having benefited from an exploration of internal auditory canals by MRI in our service at CHU de Hautepierre between January 1, 2008 and October 1, 2017

Brief summary: The symptoms of intralabyrinthine schwannomas (vertigo, deafness, instability, tinnitus) cut across the symptoms found in pressure pathologies involving the inner ear, particularly the endolymphatic hydrops.

Some publications have described dilatation of the membranous labyrinth (hydrops) in the presence of intralabyrinthine tumors.

It would be interesting to measure the size of the saccule (structure of the membranous labyrinth) in the presence of an intralabyrinthine schwannoma, to evaluate if some of the symptoms presented by the patients could be explained by the concomitant presence of an endolymphatic hydrops (accessible to drug therapy - Betahistine).


Eligibility criteria: Inclusion Criteria

* Age\> 18,
* Subject having benefited from an exploration of internal auditory canals by MRI in our service at CHU de Hautepierre between January 1, 2008 and October 1, 2017
* Presence on the MRI of the internal auditory ducts, including the realization of a high resolution fluid sequence of FIESTA-C (exploitable) type, of an intralabyrinthine schwannoma, without extension to the internal auditory canal.
* Subject who has agreed to the use of medical data for the purposes of this research.

Criteria for Non Inclusion

* Refusal of the patient to participate in the study
* Absence of high resolution fluid sequence of fast imaging employing steady state acquisition (FIESTA-C)
* Presence of movement artifacts interfering with the interpretation of the FIESTA-C sequence
* Interior surgery of the inner ear or pontocerebellar angle, without preoperative imaging Inflammatory or infectious pathology of the concomitant middle or inner ear
* Extension of schwannoma to the internal auditory canal
* Impossibility of giving the subject informed information (difficulty understanding the subject,)
* Subject under the protection of justice
* Subject under guardianship or curatorship

Primary outcomes:
measure: Size of intralabyrinth saccules
timeFrame: 1 hour after the realization of the MRI]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Imagerie 1
Study officials:
References:
Clinical trial NCT02147496: Fluid Dairy Products Consumed Before and Within a Pizza Meal on Glycemic Response, Food Intake and Satiety in Children
Official title: The Effect of Fluid Dairy Products Consumed Before and Within a Pizza Meal on Glycemic Regulation, Food Intake and Satiety in Normal Weight and Overweight/Obese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetes Prevention
Obesity Prevention
Keywords: Food intake
Appetite
Blood glucose
Insulin
Dairy
Milk
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Dairy Farmers of Canada
name: The Hospital for Sick Children
First posted: 2014-05-26
Enrollment: 57
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the effects of fluid dairy products on blood glucose and insulin, satiety and energy intake in normal weight and overweight/obese children in the age range of 9-14 y. Experiment 1: The specific objective is to examine the effects of isocaloric and isovolumetric amounts of 2% M.F. milk, 1% M.F. chocolate milk, 1.5% M.F. yogurt drink, tropical punch and water consumed before and within a pizza meal 60 min later on appetite and food intake. Experiment 2 will compare the effects of 2% M.F. milk and tropical punch consumed before and with a pizza meal 60 min later on food intake, blood glucose, and appetite hormone response.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Born at term

Exclusion Criteria:

* Diabetes
* Medications
* Lactose-intolerance or allergies to milk
* Breakfast skippers and those on an energy restricted diet

Primary outcomes:
measure: Food intake
timeFrame: 60 minute
Secondary outcomes:
measure: Blood glucose
timeFrame: 0, 30, 60, 85, 115, and 145 minute
measure: Appetite hormones
timeFrame: 0, 30, 60, 85, 115, and 145 minute
Other outcomes:
measure: Subjective Appetite
timeFrame: 0, 10, 20, 30, 60, 85, 95, 105, 115, and 145 minuites
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Harvey Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06086496: Evaluation of Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent
Official title: Evaluation of Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent in Routine Clinical Practice: A Prospective, Single-arm, Multicenter, Observational Study (The GENCOMX Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention
Lead sponsor: Genoss Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Coronary artery disease patients who underwent coronary intervention using the GENOSS DES stent

Brief summary: In real-world practice, the investigators plan to evaluate the effectiveness and safety of using the GENOSS (GENOSS DES II) stent, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease who require percutaneous coronary intervention through stent insertion.

Detailed description: This study will enroll patients who underwent percutaneous coronary intervention using the GENOSS DES stent.

This study is a single-arm, registry, observational study, so it is not necessary to calculate the number of subjects, but the investigators plan to enroll approximately 1,000 patients at 7 institutions during the registration period.

Eligibility criteria: Inclusion Criteria:

1. Adults over 19 years of age
2. Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty.
3. Severe coronary artery stenosis suitable for Genoss stent insertion
4. Patients who agree to the research protocol and clinical follow-up plan and give written informed consent in the consent form approved by the Institutional Review Board/Ethics Committee of each research institution.

Exclusion Criteria:

1. Test subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, sirolimus, contrast medium (however, even subjects with hypersensitivity to contrast medium can be controlled by steroids and pheniramine) In this case, registration is possible, but if there is known anaphylaxis, it is excluded)
2. Patients who also received other drug-eluting stents
3. If you have a disease with a remaining life expectancy of less than 1 year
4. Pregnant or lactating women or women who may be pregnant
5. Cases in which the patient was admitted to the hospital due to psychogenic shock and the likelihood of survival is medically expected to be low.
6. Patients judged by researchers to be unsuitable for research

Primary outcomes:
measure: device-oriented composite end point
timeFrame: 12 months
Secondary outcomes:
measure: patient-oriented composite end point
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
Clinical trial NCT04301596: Assessment of Nutritional Status in Systemic Sclerosis
Official title: Assessment of Nutritional Status in Systemic Sclerosis: Prospective Cohort Study in Montpellier University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Sclerosis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 150
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: The study population is patients aged 18 or more with scleroderma. From preliminary data obtained in our department, we can estimate that 50% of participants will meet the definition of malnutrition (BMI\<21kg/m2 or weigh loss \>10% in months) at baseline.

Brief summary: The main theme of the cohort of systemic sclerosis (SSc) patients is the determination of nutritional status, its evolution and the evaluation of its management in patients with scleroderma.

The main objectives are :

* To determine the incidence of malnutrition and its main determinants (disease characteristics, severity, eating habits, physical activity) in patients with scleroderma.
* For patients with undernutrition at inclusion or at 18 months follow-up:

evaluate the impact of a standardized nutritional intervention (dietary advice, oral supplements, artificial, enteral or parenteral nutrition) on nutritional and disease parameters.

Follow-up visits will take place every 6 months for 2 years. (M6, M12, M18 et M24).

During each visit: a clinical examination, with anthropometric measurements, a 3-day dietary survey and a blood sample (10 ml), completion a multiple-choice of quality of life and physical activity evaluation.

Paraclinical evaluation : echocardiography, lung function tests, screening for osteoporosis (M6 and M18).

If undernutrition is detected during a follow-up visit, the subject will be referred to a specialized service.


Eligibility criteria: Inclusion Criteria:

* All SSc patients aged 18 or more
* Patient followed at the Montpellier University Hospital
* Patients must fulfil the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria for SSc.
* Health insurance (affiliation to social security)
* Collection of non-opposition to participate in the study

Exclusion Criteria:

* Patient under the protection of justice curatorship / guardianship;
* Patients who have already planned to move out of the region in the next two years, making the follow-up impossible.

Primary outcomes:
measure: Incidence of malnutrition
timeFrame: 6 months
measure: Idetification of risk factors associated with malnutrition
timeFrame: 6 months
measure: Success of the nutritional intervention
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: Montpellier University Hospital
name: Alexandre MARIA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00580996: Water and the Gastropressor Response - Tachyphylaxis
Official title: Water and the Gastropressor Response - Tachyphylaxis (Specific Aim 1.2)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Orthostatic Hypotension
Keywords: water
orthostatic hypotension
blood pressure
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2007-12-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: We are studying the effects of oral water ingestion in patients with orthostatic hypotension. In this study, we are testing the null hypothesis that the blood pressure increase with oral water ingestion will not be diminished if a full prior water dose is given a few hours earlier.

Detailed description: We are studying the effects of oral water ingestion in patients with orthostatic hypotension. This has been termed the Gastropressor Response. In this study, we are testing the null hypothesis that the blood pressure increase with oral water ingestion will not be diminished if a full prior water dose is given a few hours earlier. In this 2 day study, subjects will be asked to drink with 1 oz or 16 oz of water in the morning followed a few hours later by 16 oz water while the blood pressure is monitored. On the 2nd day, the other dose of water will be given to start, with 16 oz again as the second dose.

Eligibility criteria: Inclusion Criteria:

* orthostatic hypotension (fall in BP\>20/10 mmHg)
* pressor response to water in other studies
* Age 18-80 years

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: blood pressure
timeFrame: 2nd water intervention
Secondary outcomes:
measure: heart rate
timeFrame: 2nd intervention
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Satish R Raj, MD MSCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01513096: Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation
Official title: Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Bowel Preparation
Keywords: colonoscopy
bowel preparation
PEG
Prokinetics
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In bowel preparation using split dose PEG, various adjuncts to colonic cleansing were proposed to improve colonic preparation cleansing. Prokinetics, as an adjunct, was included in a few studies. The investigators study was to show that sufficient dosage of prokinetics added to split dose of PEG improves the state of bowel preparation.

Detailed description: This was a randomized, prospective, endoscopist-blinded clinical trial in which the efficacy of prokinetics coadministrated with split dose PEG on the bowel cleansing was inspected.

Endoscopists, who were blinded to the study group of the patient, immediately completed the Ottawa scale and the fluidity scale after procedure

Eligibility criteria: Inclusion Criteria:

* Patient who are scheduled for colonoscopy

Exclusion Criteria:

* pregnancy,
* breast feeding,
* known or suspected bowel obstruction, and
* known allergy to PEG or Itopride ,
* presence of severe illness(renal failure, congestive heart failure, liver failure,), and
* refusal of consent to participate in the study

Primary outcomes:
measure: bowel cleaning quality according to Ottawa scale scores
timeFrame: 3 months
Secondary outcomes:
measure: procedure time and polyp detection rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Haeundae Paik Hospital, Inje University School of Medicine
Study officials:
References:
Clinical trial NCT03374696: Theater in School Sex Education - a Randomized Controlled Study
Official title: Prevention of Chlamydia Infection With Theater in School Sex Education - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attitude
Sexual Behavior
Condom Use
Prevention
Chlamydia Infections
Safe Sex
Keywords: Chlamydia infections
condoms
theater,
sex education
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 826
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized controlled trial with parallel assignment
Primary purpose: PREVENTION

Brief summary: The study evaluated if interactive theater in school sex education affects student knowledge, attitudes and behavior regarding condom use. The intervention group got a play, value exercises, chlamydia games, condom school and interactive replay with professional actors and staff from a youth guidance center. The control group got standard sex education from school staff, based on the education guidelines of the Swedish National Agency for Education.

Detailed description: The spread of chlamydia indicates that current preventive work with condoms is insufficient. Research shows that reasons behind increased chlamydia include youths taking more sexual risks, due to altered attitudes and sexual behaviors. Since only condoms protect against both sexually transmitted infections (STIs) and unwanted pregnancy, the goal of the World Health Organization (WHO) chlamydia prevention program is to increase condom use. Research suggests that school is the most important arena for sex education, reaching all youths early in life, when many values on sex and relationships are instilled. International studies on theater in sex education indicate effects like increased knowledge on the topic, and partially changed attitudes and behaviors among youths. Furthermore, several studies show that youths feel theater is a good method for sex education and a supplement to standard education.

Eligibility criteria: Inclusion Criteria:

* students in eighth grade
* could read and understand Swedish

Exclusion Criteria:

* students in special education.

Primary outcomes:
measure: - Knowledge of condom use and chlamydia. - Attitudes toward condom use. - Behavior relating to condom use.
timeFrame: One month.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Orebro University, School of Health Sciences
name: Annsofie Adolfsson, Med Dr
role: PRINCIPAL_INVESTIGATOR
References: