louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05478564: Hemodynamic Monitoring During Abdominal Aortic Surgery
Official title: INTRAOPERATIVE HEMODYNAMIC MANAGEMENT IN ABDOMINAL AORTIC SURGERY GUIDED BY HYPOTENSION PREDICTION INDEX (HPI) - HEMAS Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamic Instability
Lead sponsor: Humanitas Clinical and Research Center
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults submitted to open surgery due to abdominal aorta repair

Brief summary: This trial investigates the ability of our istitutional algorithm in maintaining a safe hemodynamics during abdominal aorta open surgery, in terms of limitation of intraoperative hypotension incidence

Detailed description: The present trial includes patients submitted to abdominal aorta open surgery. This type of procedure is very challenging for the hemodynamic management because of the operation per se (during which the surgeon clamp and unclamp the aorta with very significant hemodynamic variations) and because of the altered tone of the vessels due to the general vascular disease such a type of patients is suffering from.

The aim of this study is to verify if the incidence of intraoperative hypotension in terms of severity, lasting and number of episodes, may be reduced by the application of a protocol of hemodynamic management.

Primary endpoint: Global time spent in hypotension \<10%.

Secondary Endpoints:

1. Time Weighted Average (TWA) of Area Under the Threshold \<0.4 mmHg
2. Incidence of hypotensive events/patient \< 8 (including the expected hypotensive events due to the aortic clamping and unclamping)

Eligibility criteria: Inclusion Criteria:

* Adults patients undergoing abdominal aorta open surgical repair

Exclusion Criteria:

* Emergent/urgent operation
* Age \<18 years
* Pregnancy
* Intra-operative blood loss \> or = 3000ml

Primary outcomes:
measure: Global time spent in hypotension <10%
timeFrame: Intraoperative period
Secondary outcomes:
measure: Time Weighted Average (TWA) of Area Under the Threshold <0.4 mmHg
timeFrame: Intraoperative period
measure: Incidence of hypotensive events/patient < 8
timeFrame: Intraoperative period
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Clinical and Research center
state: Milan
Study officials:
References:
Clinical trial NCT03242564: Effects of Red Light LED Therapy on Body Contouring
Official title: A Retrospective Analysis of the Effects of Red Light LED Therapy on Body Contouring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Vevazz, LLC
Sponsor class: INDUSTRY
First posted: 2017-08-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether red light therapy using LED 650nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using Laser 635nm red light.

Detailed description: Red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. This study hypothesizes that red LED light therapy using 650nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when preformed using a specified treatment protocol.

Furthermore, it is hypothesized that the Vevazz therapy program achieves the results after a single 28 minute treatment. The predicate 635nm LED device (Photonica Professional by Ward Photonics) achieves its results after one 32 minute therapy program.

The Vevazz therapy program uses the Vevazz LED device for fat removal using LED red light therapy. This multi-site study reviews results from 66 randomly selected patients after a single treatment using the Vevazz LED device.

Eligibility criteria: Inclusion Criteria:

* At least 18 years or older.
* May be male or female.
* Generally good health.

Exclusion Criteria:

* Minors.
* Open wounds or sores.
* Pacemaker.
* Photosensitivity.
* Epilepsy.
* Any form of cancer.
* Severe kidney or liver problems.
* Thyroid problems.
* Pregnant or nursing.

Primary outcomes:
measure: Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost
timeFrame: One 28 minute treatment session.
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Vevazz, LLC
state: Texas
Study officials:
affiliation: Owner
name: Jamie Fettig
role: STUDY_DIRECTOR
References:
Clinical trial NCT02216864: Effect of Multiple Subcisions on Rolling Acne Scars
Official title: Pilot Split Face Randomized, Evaluator Blinded Study on the Effect of Multiple Subcisions on Rolling Acne Scars
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acne Scars
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether the use of multiple subcisions over several visits will improve the appearance of rolling acne scars compared to no treatment.

This study was a pilot study designed to determine feasibility of this procedure.


Eligibility criteria: Inclusion Criteria:

1. Age 18 to 65
2. Have bilateral rolling acne scars on each side of their face
3. No active or ongoing acne.
4. The subjects are in good health
5. The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

1. Under 18 years of age
2. Pregnancy or Lactation
3. Subjects who are unable to understand the protocol or to give informed consent
4. Subjects with mental illness
5. Recent Accutane use in the past 6 months
6. Subjects prone to hypertrophic and keloidal scarring
7. Subjects reporting any blood diseases (HIV, Hepatitis, etc.)
8. Subjects reporting a history of Herpes (oral or genital)

Primary outcomes:
measure: Change in acne scarring compared to baseline after treatments
timeFrame: Baseline and 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06092164: Visual Outcomes of Functional Intraocular Lenses in Cataracts
Official title: Visual Outcomes of Different Types of Functional Intraocular Lenses in Cataract Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cataract
Visual Quality
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 20000
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: Catarct

Brief summary: This is a prospective, multi-center, randomized comparative study. The purpose of the study is to evaluate and compare the objective and subjective visual outcomes of different types of functional intraocular lenses (IOLs) in patients.

Detailed description: Analyzing the subjective and objective visual outcomes and related factors following the implantation of various types of intraocular lenses（bifocal, trifocal, extended depth of focus (EDOF), and astigmatism-correcting intraocular lenses), exploring the advantages, disadvantages, and suitable patient populations for different types of intraocular lenses, analyzing the factors affecting postoperative visual quality, and providing guidance to better assist patients with diverse needs in clinical settings, aiming to offer multidimensional postoperative visual quality."

Eligibility criteria: Inclusion Criteria:

* cataract
* age \> 18 years

Exclusion Criteria:

* amblyopia; previous ocular surgery;
* ocular pathologies such as diabetic retinopathy, macular degeneration, glaucoma with field defects;
* requirements for further ocular surgery (other than Nd:YAG capsulotomy) or retinal laser treatments during the study

Primary outcomes:
measure: uncorrected distance visual acuity (UDVA)
timeFrame: one year
measure: best corrected distance visual acuity (BCVA)
timeFrame: one year
measure: uncorrected near visual acuity (UNVA)
timeFrame: one year
measure: uncorrected intermediate visual acuity (UIVA)
timeFrame: one year
Secondary outcomes:
measure: HOAs
timeFrame: three months
measure: Strehl Ratio
timeFrame: three months
measure: objective visual quality
timeFrame: three months
measure: contrast sensitivity
timeFrame: three months
measure: visual functions
timeFrame: three months
measure: IOL condition
timeFrame: three months
measure: subjective satisfaction
timeFrame: three years
measure: photic phenomena
timeFrame: three years
Other outcomes:
Locations:
Study officials:
affiliation: Department of Ophthalmology, Eye and Ear, Nose, and Throat Hospital, Fudan University
name: Jin Yang
role: STUDY_DIRECTOR
References:
Clinical trial NCT06168864: Development of Artificial Intelligence Models for Segmentation and Characterization of Prostate Cancer: a Single-center Retrospective Observational Study.
Official title: Development of Artificial Intelligence Models for Segmentation and Characterization of Prostate Cancer: a Single-center Retrospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 350
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with prostate cancer undergoing PET examination with 68 Ga-PMSA (PET/CT or PET/MRI), since 01/06/2020, at the U.O. of Nuclear Medicine at the San Raffaele Hospital on the clinical indication of the specialist.

Brief summary: Prostate cancer is the second most common cancer in the male population. This pathology represents an oncological and public health problem especially in developed countries, due to a greater presence of elderly men in the population.

Medical imaging plays a central role in the staging and restaging of prostate disease. Magnetic resonance imaging (MRI), computed tomography (CT) and positron emission tomography (PET) are among the methods commonly used in normal clinical practice for the characterization of prostate cancer. To date, the study of these images is limited to a qualitative visual analysis, however there is increasing evidence relating to the usefulness of introducing a quantitative (or semi-quantitative) analysis of biomedical images.

The current increase in available imaging data, and their quality, allows the application of artificial intelligence methods also in the medical field for the automation of tasks (e.g. automatic segmentation) and classification (e.g. tumor aggressiveness).

The extraction of quantitative data, and more generally the study of tumor lesions, requires manual segmentation by one or more doctors. This process requires very long times as each image must be processed individually; furthermore, the result also depends on the level of experience of the doctor carrying out the segmentation and this could create a source of heterogeneity, affecting the reproducibility of the segmentation.

AI-based automatic segmentation methods can be applied to medical images for the localization of tumor lesions, thus exceeding the limits of manual segmentation.


Eligibility criteria: Inclusion Criteria:

* Patients with histological diagnosis of prostate cancer;
* Patients who performed a PET exam with 68 Ga-PMSA.

Exclusion Criteria:

* CT and MR images with artifacts that preclude interpretation of results.

Primary outcomes:
measure: Artificial intelligence algorithms for the classification of prostate cancer lesions on medical images.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Irccs San Raffaele
Study officials:
References:
Clinical trial NCT02717364: Yervoy® Postmarketing Surveillance for Patients in Japan With Unresectable, Malignant Melanoma
Official title: Yervoy® Postmarketing Surveillance for Patients in Japan With Unresectable, Malignant Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2016-03-23
Enrollment: 556
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: This study is a local, prospective, non-interventional, non-controlled, multicenter, observational study (regulatory postmarketing surveillance). Each physician will enroll patients who have received at least 1 dose of Yervoy, and each patient will be followed for up to 12 months. All patients will be evaluated for safety and effectiveness during Yervoy use (4 doses) and for 12 months from the first dose of Yervoy to confirm the safety profile of Yervoy under routine, daily practice


Eligibility criteria: Inclusion Criteria:

* All patients who are initiating treatment with Yervoy

Exclusion Criteria:

* Not Applicable

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: The incidence of adverse events (AEs) by types among the analysis population
timeFrame: 12 months
measure: The Overall Survival (OS) Rate
timeFrame: 12 months
measure: The factors that potentially affect safety or effectiveness
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chiyoda-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Tokyo
country: Japan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02576964: A Study of Capecitabine (Xeloda) and Peginterferon Alfa-2a (Pegasys) in Treatment-Naive Participants With Advanced Liver Cancer
Official title: An Open-Label Phase II Study of Capecitabine in Combination With Pegylated Interferon Alfa-2a in Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-10-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of capecitabine (Xeloda) in combination with peginterferon alfa-2a (Pegasys) in participants with advanced liver cancer who have had no prior treatment. The anticipated time on study treatment is until disease progression, and the target sample size is 43 individuals.


Eligibility criteria: Inclusion Criteria:

* Adults 18 to 75 years of age
* Locally advanced or metastatic liver cancer with measurable disease and not eligible for any standard therapy

Exclusion Criteria:

* Previous treatment for liver cancer
* Main portal vein involvement
* Bone, brain, or leptomeningeal metastasis
* Clinically significant cardiac disease
* Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract
* History of other cancer, except basal cell skin cancer or in situ cancer of the cervix

Primary outcomes:
measure: Objective response rate
timeFrame: up to post-chemotherapy follow-up ( approximately 46 months)
Secondary outcomes:
measure: Time to disease progression
timeFrame: Up to approximately 46 months
measure: Duration of response
timeFrame: Up to approximately 46 months
measure: Overall survival
timeFrame: Up to approximately 46 months
measure: Incidence of adverse events
timeFrame: Up to approximately 46 months
Other outcomes:
Locations:
city: Beijing
country: China
city: Guangzhou
country: China
city: Kueishan
country: Taiwan
city: Tainan
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Songkhla
country: Thailand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT04351464: Is Reflexology Applied to Children With Cerebral Palsy an Effective Method?
Official title: Is Reflexology Applied to Children With Cerebral Palsy an Effective Method?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Reflexology
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Objectives: This study was planned to investigate the influence of reflexology applied to children with cerebral palsy together with physical therapy program involving neurodevelopmental approaches.

Methods: The study involved 40 children aged,16 girls and 24 boys between 3 and 15 years and divided into two groups. While the children in Group 1 were given twice a week for eight weeks neurodevelopmental treatment, reflexology was applied to those in Group 2 together with neurodevelopmental treatment. Drooling Severity and Frequency Scale, Pediatric Sleep Questionnaire and the Children's Health Questionnaire was used to assess the drooling, status of sleep and quality of life in children.

Detailed description: The study involved a total of 40 children aged between three and 15 diagnosed with CP by a pediatric neurologist. Children at levels 3/4/5 of the GMFCS who did not have any open wounds on the foot, where the application was to be performed, and whose parents consented to the child's participation were accepted in the study. However, those children were excluded who were treated with botulinum toxin in the last six months, underwent surgery, were treated with reflexology or any other alternative medicine method and who had refractory epilepsy.

Eligibility criteria: Inclusion Criteria:

* Children at levels 3/4/5 of the GMFCS who did not have any open wounds on the foot, where the application was to be performed, and whose parents consented to the child's participation were accepted in the study.

Exclusion Criteria:

* who were treated with botulinum toxin in the last six months, underwent surgery, were treated with reflexology or any other alternative medicine method and who had refractory epilepsy.

Primary outcomes:
measure: physiological parameter
timeFrame: 8 weeks
measure: Questionnaire about Sleep status
timeFrame: 8 weeks
measure: Questionnaire about Quality of life of children
timeFrame: 8 weeks
Secondary outcomes:
measure: Physical parameter
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Sabiha Bezgin
Study officials:
References:
Clinical trial NCT02082964: The Effect of SCIM on Neonatal Resuscitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 48
Sex: ALL
Minimum age (years): 22
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: In this randomized controlled trial 48 students were randomly allocated in three groups SCIM, Video training (VT) and control group(no training). They had a workshops based on NRP and lasted 6 hours for each group. Before and after the workshops and one month later all students participated in a 7 station OSCE..


Eligibility criteria: Inclusion Criteria:

healthy, without any history of severe stress in the past 6 months prior to the study. Accepts Healthy Volunteers

Exclusion Criteria:severe stress

-

Primary outcomes:
measure: education
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
Study officials:
References:
Clinical trial NCT00347464: Adaptive Behavior Assessment of Men With 49, XXXXY, Klinefelter Syndrome
Official title: Adaptive Behavior Assessment of Men With 49, XXXXY, Klinefelter Syndrome
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Klinefelter Syndrome
Keywords: Kleinfelter
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Solvay Pharmaceuticals
First posted: 2006-07-04
Enrollment: 0
Sex: MALE
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Klinefelter males ages 2-21 with proven 49,XXXXY karyotype

Brief summary: Klinefelter syndrome, a congenital chromosomal abnormality with one or more extra X chromosomes, occurs in out of 400 live male births. The majority of Klinefelter men present with a 47, XXY karyotype. The "poly-X variant", with the 49,XXXXY karyotype is uncommon. This syndrome, where subjects have two or more X chromosomes presents with primary hypogonadism, and, particularly if associated with the 49,XXXXY karyotype, significantly impacts life skills across a variety of dimensions, including areas of communication, community use, functional academics, home/school living, health and safety, leisure, self-care, self direction, and work. Adaptive behavior abnormalities in 46,XXY men are well known and described. In the poly-X variant of the 49,XXXXY karyotype, adaptive behavior abnormalities are expected to be much more significant, making these patients eligible for services and Social Security benefits.

In 49,XXXXY men no study to date has examined these areas of inquiry in a large patient population, using a psychometrically sound instrument in a large patient population. Current publications are limited to individual case reports or small case summaries. It is important to study the adaptive behavior in its highly abnormal presentation in 49,XXXXY men in order to learn more about the effect of additional X chromosomes on adaptive skills, which determine how an individual responds to daily demands and in order to develop treatment and training goals.


Eligibility criteria: Inclusion Criteria:

* Any Klinefelter male with proven 49,XXXXY karyotype, who does not present with and is not being treated for significant physical/mental illness which might affect his adaptive behavior, who or whose parent or primary caretaker is able to provide informed consent to participate in the study and who or whose parent or primary caretaker has adequate command of the English language, to provide meaningful information will be invited to participate in this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Wolfram E Nolten, MD
role: PRINCIPAL_INVESTIGATOR
References: