louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02918942: Tympanoseal (Tympanic Membrane Device) Clinical Study
Official title: Tympanoseal (Tympanic Membrane Device) Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Tympanic Membrane Perforation
Lead sponsor: Grace Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-29
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this investigational study is to assess the ability of Tympanoseal (sodium/calcium alginate), an investigational device, to act as a scaffold during healing of the tympanic membrane. Tympanoseal is intended for use following removal or extrusion of indwelling tympanostomy tubes or traumatic injury of the tympanic membrane.

Detailed description: This study will provide data on the safety and the ability of sodium/calcium alginate gels to act as a scaffold capable of occluding a tympanic membrane perforation over the duration of complete healing. Tympanoseal could be used in cases where cartilage or fat graft tympanoplasty would be indicated.

Eligibility criteria: Inclusion Criteria:

* Male or female patients over 2 years of age at enrollment
* Documentation of a retained tympanostomy tube or persistent perforation less that 5 mm.
* Written informed consent (and assent when applicable) obtained from subject or subject's legal guardian and ability for subject to comply with the requirements of the study

Exclusion Criteria:

* Active otorrhea or otitis media
* History of cholesteatoma
* Perforations on the edge of the tympanic membrane
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
* Subject is taking systemic corticosteroids
* Subject requires continued use of any type of topical otic medication

Primary outcomes:
measure: Number of Serious Adverse Events
timeFrame: 16 weeks
Secondary outcomes:
measure: Number of Participants With Treatment-related Adverse Events
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Plano
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT03909542: Malnutrition Associated With Complications After Ileostomy Reversal
Official title: Postoperative Complications in Patients With Inflammatory Bowel Disease: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Ileostomy
Keywords: inflammatory bowel disease
ileostomy
ileostomy reversal
stoma reversal
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 359
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have had an ileostomy closure procedure

Brief summary: An ileostomy is a surgical opening established by bringing the end or a loop of the ileum to discharge directly outside the body. This is typically done when part or the entire colon is removed because of IBD, cancer, or familial adenomatous polyposis. Reversal of this procedure, an ileostomy closure, may be done if possible. Ileostomy closure involves reconnecting the ileum to the remaining colon, allowing normal bowel movements again. This study will look at the outcomes of these surgeries in patients who were seen and operated on by the investigators.

Detailed description: This study focused on outcomes and complications after ileostomy closure. An ileostomy is a surgical opening established by bringing the end or a loop of the ileum to discharge directly outside the body. This is typically done when part or the entire colon is removed because of IBD, cancer, or familial adenomatous polyposis. Reversal of this procedure, an ileostomy closure, may be done if possible to reconnect the ileum to the remaining colon and allow normal bowel movements again. This study looked at the outcomes for these surgeries in patients who were seen and operated on by the investigators. Patients were identified from the files and schedules of the investigators, and Epic was used to collect the information needed to determine perioperative clinical characteristics and post-operative outcomes. This data was kept in a secure electronic database, with identifiers removed as soon as all of the data was collected for a patient.

Eligibility criteria: Inclusion Criteria:

* ileostomy closure procedure

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of Complications
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Joel J Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03299842: A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome
Official title: An Exploratory, Pilot Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome: A Sub-study to the ZX008-1503 Open-Label Extension Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dravet Syndrome
Keywords: seizure
tonic clonic
epilepsy
myoclonic
encephalopathy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-10-03
Enrollment: 5
Sex: ALL
Minimum age (years): 2
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: ZX008-1503 Fenfluramine, open-label
Primary purpose: TREATMENT

Brief summary: This is an exploratory sub-study to ZX008-1503 \[NCT02823145\]. Subjects will be fitted with an Embrace seizure detection watch and seizures detected by the watch will be compared to those entered into an electronic seizure diary.

Detailed description: This sub study will include up to 20 participants who meet the entry criteria for the main Study ZX008-1503 and who are willing to wear the Embrace watch and use the Embrace Alert app for 12 consecutive weeks. Those invited to participate will undergo all procedures included in the main study during their participation in this sub-study,

Eligibility criteria: Inclusion Criteria:

* Meeting all of the main study ZX008-1503 \[NCT02823145\] inclusion criteria
* Subject is willing to wear the Embrace watch on the wrist (alternatively ankle, if needed for younger children). Subjects are asked to wear the watch for as many hours of the day as possible and for the entire night, if possible, for the duration of the sub-study.
* Subject's parent/caregiver is willing to use the Alert App.
* Subject/subject's caregiver is willing to ensure that the Embrace watch remains within close proximity of the paired iPod Touch running the Empatica Alert app.

Exclusion Criteria:

* Subject has a known hypersensitivity to any of the Embrace device materials.
* Subject has a clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to Visit 1, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.

Primary outcomes:
measure: Overall Usability of the Empatica Embrace Seizure Detection Watch System (Embrace) in Outpatients With Dravet Syndrome
timeFrame: Approximately 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Aurora
country: United States
facility: The Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References:
Clinical trial NCT04636242: Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis
Official title: Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: C. Acnes
Phototherapy
Postoperative Infection
Arthroscopic Rotator Cuff Repair
Shoulder Surgery
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective, randomized controlled trial to evaluation the ability of 5-aminolevulinic acid HCL topical solution photodynamic therapy to decrease the colonization of Cutibacterium acnes (C. acnes- a bacteria commonly found in the dermis of the skin surrounding the shoulder) in order to decrease postoperative joint infections.

-Aminolevulinic acid (ALA) is a naturally occurring metabolite in the synthesis of pathway of cellular heme production. Adding ALA to bacteria encourages porphyrin production which serve as the immediate precursors to heme production. When these porphyrins are illuminated with blue light at an emission peak of 407-420nm, these metabolites become exothermic and cause internal destruction of the bacterial cells. This therapy does not cause any damage to the mammalian cells, which makes PDT safe for human skin treatment.


Eligibility criteria: Inclusion Criteria:

* All male patients (\>18) undergoing shoulder arthroscopy)

Exclusion Criteria:

* Female patients
* Patients with active acnes
* Patients who have taken antibiotics within a month of their surgery
* Subjects with psoriatic/eczematous lesions on the shoulder girdle
* Patients on anticoagulant therapy
* Patients who have a known allergy to any of the agents used in the study protocol

Primary outcomes:
measure: Change in the number of patients who have microbiological results positive for the bacteria C. acnes after treatment with 5-aminolevulinic acid-photodynamic therapy (ALA-PDT) versus those who were not.
timeFrame: 13 days
Secondary outcomes:
measure: Decrease Rate of Postoperative Infection
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04022642: Effects of HIIT Integrated in PE Classes, on Physical Condition, Physical Activity and Motivation for Exercise
Official title: Effects of a High-Intensity Interval Training Program Integrated in High-School Physical Education Classes, on Physical Condition, Physical Activity and Motivation for Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescents
Keywords: HIIT
Adolescents
Physical Exercise
Health
Motivation
Lead sponsor: University of Évora
Sponsor class: OTHER
Collaborators: name: Agency for Science, Technology and Research
First posted: 2019-07-17
Enrollment: 274
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Levels of activity and physical condition among adolescents are low, increasing the risk of chronic diseases. The most recent literature suggests that physical activity and physical condition are correlated with improved biopsychosocial variables of the young. The School and, concretely, the Physical Education classes are privileged spaces, promoters of positive changes for the rest of the life. HIIT is an efficient alternative to the invested time compared to aerobic training, being a powerful stimulus in improving cardiorespiratory performance, muscles oxidative capacity and sensitivity to insulin. This study intends to verify the effectiveness and feasibility in the implementation of HIIT in High-School Physical Education classes. The activity levels and physical condition of the adolescents will be evaluated and identified, before and after 16 weeks of implementation of the training program, as well as their effects on the motivation for the practice.


Eligibility criteria: Inclusion Criteria:

* Students enrolled in years 10-12

Exclusion Criteria:

* Students will be ineligible if they do not provide parental consent to participate

Primary outcomes:
measure: Change from baseline Cardio-respiratory fitness at 4 months
timeFrame: 4 months
measure: Change from 4 months Cardio-respiratory fitness at 6 months
timeFrame: 6 months
measure: Change from baseline Muscular Strength at 4 months
timeFrame: 4 months
measure: Change from 4 months Muscular Strength at 6 months
timeFrame: 6 months
measure: Change from baseline Body Mass Index (BMI) at 4 months
timeFrame: 4 months
measure: Change from 4 months Body Mass Index (BMI) at 6 months
timeFrame: 6 months
measure: Change from baseline Physical Activity at 4 months
timeFrame: 4 months
measure: Change from 4 months Physical Activity at 6 months
timeFrame: 6 months
measure: Change from baseline Motivation at 4 months
timeFrame: 4 months
measure: Change from 4 months Motivation at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beja
country: Portugal
facility: Escola Secundária D. Manuel I
Study officials:
affiliation: University of Évora
name: André Bento
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06376370: The Effect of a Computer-Assisted Rehabilitation Program on Epilepsy Patient
Official title: The Effect of RehaCom Computer-Assisted Rehabilitation Program on Self-Management, Cognitive Function and Quality of Life in Epilepsy Patients: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Epilepsy
Computer-assisted Cognitive Rehabilitation
Quality of Life
Keywords: Epilepsy patient
Cognitive rehabilitation
Self management
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to examine the effects of the RehaCom Computer-Assisted Rehabilitation Program Applied to Epilepsy Patients on Self-Management, Cognitive Function and Quality of Life.

Detailed description: Modules designed to train cognitive abilities will be used under the supervision of a licensed researcher who is licensed to use the RehaCom application, which is a computer-assisted cognitive rehabilitation program. Researchers can select some modules based on each patient's specific deficits, meaning that deficits can be targeted and specifically trained. Since the program will respond to the patient's specific needs, the activity may become easier or more difficult depending on the patient's performance. Epilepsy patients will be encouraged by researchers during the exercises and will be able to give feedback on progress at the end of the session. After determining the appropriate time and day for each patient in the experimental group, the intervention will continue for 6 weeks with 45-minute sessions once a week.

Eligibility criteria: Inclusion Criteria:

* Being registered at Selçuk University Faculty of Medicine Hospital Neurology Polyclinic
* Having been diagnosed with epilepsy for at least 6 months
* Being between the ages of 18 and 60 (60 is the age limit for the Moxo test)
* Volunteer to provide transportation to Selçuk University Faculty of Medicine for research one day a week.
* Ability to use tools such as computer mouse and telephone
* Score 24 or more from the Mini Mental State Test

Exclusion Criteria:

* Individuals have physical, mental, visual and hearing disabilities
* Having another neurological disorder
* The individual has a transportation disability

Primary outcomes:
measure: Mini Mental State Test
timeFrame: 5 minutes
measure: Epilepsy Quality of Life Scale
timeFrame: 10 minutes
measure: MOXO Test
timeFrame: 18 minutes
measure: Epilepsy Self-Management Scale
timeFrame: 12 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Selçuklu
country: Turkey
facility: ülkü Saygili Düzova
state: Konya
Study officials:
References:
Clinical trial NCT00681070: Cosmetic Outcomes of Absorbable Versus Non-absorbable Sutures in Pediatric Facial Lacerations
Official title: Cosmetic Outcomes of Absorbable Versus Non-absorbable Sutures in Pediatric Facial Lacerations, Part 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lacerations
Wounds
Keywords: laceration
wound management
absorbable sutures
cosmetic outcomes
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2008-05-21
Enrollment: 74
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our research hypothesis in this study is that there is no difference in long-term cosmetic outcomes between absorbable sutures and non-absorbable sutures in the repair of pediatric facial lacerations.

Detailed description: The standard method of repair for facial lacerations is to close such wounds with non-absorbable sutures. Recently, topical skin adhesives such as n-butyl-2-cyanoacrylate and 2-octyl cyanoacrylate have been used more frequently as these have been shown to be a faster and less painful way to close superficial facial lacerations. However, lacerations that are deeper, gaping or occurring along lines of excessive tension, such as the chin, still need sutures for repair. Non-absorbable sutures have to be taken out at 4-7 days. This involves another physician visit, parental absence from work, and children who need to be taken out of school or daycare for a simple suture removal.

In Part Iof the study, we were able to demonstrate non-inferiority of absorbable sutures to nylon sutures. However, we purposely removed all remaining absorbable sutures on the 5-7 day follow-up visit. In Part II, we will allow the absorbable sutures to dissolve on their own. We will again assess long term cosmetic outcomes, as well parental satisfaction, and short and long-term complication rates at 3 months.

Eligibility criteria: Inclusion Criteria:

* Clean. minimally contaminated facial lacerations, between 1-5 cms long, less than 8 hours old, not caused by animal bites, not needing plastic surgery repair

Exclusion Criteria:

* Pregnancy
* Bleeding
* Renal
* Endocrine problems
* Dirty wounds
* Irregular wounds

Primary outcomes:
measure: cosmetic outcomes
timeFrame: 3 months
Secondary outcomes:
measure: infection
timeFrame: 4-6 days
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Cardinal Glennon Children's Hospital
state: Missouri
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01146470: The Influence of Red Grape Cells on Blood Pressure Vascular Function in People With Hypertension
Official title: A Single-Center, Double-blind, Random, Parallel Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Fruitura Bioscience Ltd.
First posted: 2010-06-17
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study hypothesis is that 3 Months Daily Supplementation of RGC will effect blood pressure and vascular function.

This will be a single-center, double-blind, random, parallel controlled Study. Study population will include 60 subjects, who will be divided randomly into three groups. The first group will get RGC 200mg, the second group will get RGC 400mg, and the third group will get 200mg placebo.


Eligibility criteria: Inclusion Criteria:

* Age 35-70
* BMI \< 40.0 kg/m2
* Blood pressure: SYS. ≤154 mmHg, DIA. ≤93 mmHg.

Exclusion Criteria:

* Breastfeeding or pregnancy.
* Milk allergy - the substance may contain traces of milk protein (casein).
* Taking anti-hypertensive medications.
* Taking antioxidant food supplements, excluding probiotic agents and fibers (taken for less than two weeks before beginning the study).
* Subjects suffering from any of the following conditions: cardiovascular disorders, renal disorders, intestinal disorders, hepatic disease, malignant or autoimmune diseases or other metabolic diseases.
* A subject whose baseline blood tests indicate abnormalities in hepatic or renal function, thyroid function or blood count.
* Unusual eating habits.
* The subject is in the process of active weight loss / gain.
* Addiction to drugs / alcohol.
* Medically documented psychiatric problems or neurological disorders.
* Smokers. (Subjects who quit smoking more than two years ago may be included in the study).
* Systolic blood pressure above 154 mmHg.
* Diastolic blood pressure above 93 mmHg.
* Taking phosphodiesterase 5 inhibitors for the treatment of erectile dysfunction (Viagra, Cialis, etc.).

Primary outcomes:
measure: To investigate the influence of RGC on blood pressure and vascular function.
timeFrame: 3 months of treatment
Secondary outcomes:
measure: The change in oxidative stress parameters
timeFrame: 3 months of treatment
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center, Israel
name: Nachum Vaisman, Professor
role: PRINCIPAL_INVESTIGATOR
References: