louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03809520: An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA
Official title: An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthopedic Disorder
Trauma
Ankle Fractures
Post-traumatic Osteoarthritis
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
First posted: 2019-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The immediate goal of the proposed research is to test the value of a new low-cost, low-dose standing CT system for efficient early detection of both joint degeneration and elevated contact stress. The standing CT scanner holds promise for detecting arthritic changes earlier than other imaging modalities because of the combination of its 3D nature and ability to image joints in a weight-bearing pose. A secondary goal of the proposed research is to enable predictive models for osteoarthritis risk based on measures of post treatment contact stress, both to inform treatment and so that new interventions can be tested in a manner incorporating risk stratification.

Detailed description: Individuals who present with an intra-articular of the tibial plafond will be consented to participate in this study. We will obtain pedCAT scans at 6, 12, and 18 months post-injury, as well as several questionnaires that will be administered during the clinical visits. We will also review the subjects' electronic medical record for data related to the injury, including the timing and mechanism of injury, time from injury to surgery, length of hospital stay, any complications and/or subsequent ankle surgeries, as well as any clinic notes, imaging, and/or outcomes scores related to the calcaneus fracture.

Eligibility criteria: Inclusion Criteria:

* Individuals 18 to 70 years old Sustained an intra-articular fracture of the tibial plafond Indicated for operative treatment Present for treatment within 4 weeks of injury

Exclusion Criteria:

* Women who are pregnant or planning on becoming pregnant Individuals younger than 18 and older than 70

Primary outcomes:
measure: Changes in the ankle joint space width
timeFrame: 18 months
Secondary outcomes:
measure: Change in ankle pain
timeFrame: 18 months
measure: Change in ankle function
timeFrame: 18 months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: J L Marsh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01477320: Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.
Official title: Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. Prospective, Double-blind, Randomized, Placebo-controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Hemorrhage
Clostridium Difficile Colitis
Keywords: Enteral Nutrition
Stress Ulcer Prophylaxis
Critically Ill Patients
Overt and significant GI bleeding
Stress gastropathy
Clostridium Difficile pseudomembranous colitis
Vital AF
Small peptide fish oil structured lipids
Fructose oligosaccharide
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Abbott Nutrition
name: University of Louisville
First posted: 2011-11-22
Enrollment: 124
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: study is to determine if proton pump inhibitors plus enteral nutrition is superior to enteral nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in terms of incidence of overt and significant GI bleeding related to stress gastropathy.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Admission to the medical ICU at University of Louisville Hospital or Jewish Hospital
* Expected need for mechanical ventilation \> 48 hours
* No contraindication to EN within the first 24 hours after admission to the ICU

Exclusion Criteria:

* Evidence of active GI bleeding during current hospitalization prior to study entry
* Admission to ICU with primary diagnosis of burn injury
* Closed head injury or increased intracranial pressure
* Partial or complete gastrectomy
* Pregnancy or lactation

Primary outcomes:
measure: Number of Subjects With GI Bleeding
timeFrame: Subjects will be followed from date of randomization until discharge from the ICU or cessation of Enteral Nutrition (EN) and successful initiation of oral feeds up to 100 weeks.
Secondary outcomes:
measure: Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis.
timeFrame: Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks.
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Mohamed Saad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05201820: Cryoanalgesia for Pain Management After Pectus Excavatum Repair
Official title: Cryoanalgesia for Pain Management After Pectus Excavatum Repair. COPPER Study (CryoanalgesiafOr Pain Management After Pectus Excavatum Repair): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pectus Excavatum
Lead sponsor: Istituto Giannina Gaslini
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 88
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cryoanalgesia for pain management after pectus excavatum repair. COPPER study (CryoanalgesiafOr Pain management after Pectus Excavatum Repair): a randomized controlled trial.

Determine if, in patients more than 12 years of age having cryoanalgesia for pectus excavatum repair analgesia improves the standard of care (epidural analgesia) in term of pain relief and return to normal life 2 weeks after surgery.

Randomized active controlled, parallel group, single-centre, trial (category IIb medical device).

88 patients aged more than 12 years of age scheduled for pectus excavatum repair. After randomization, patients will receive intraoperative cryo-analgesia or standard of care (epidural-analgesia).

PedsQLscale (23 items) two weeks after surgery.

Patients will be followed for 6 months after surgery to determine time until return to normal life and occurrence of any complication related to the use of cryo-analgesia. Numeric Rating Scale (NRS), CALI9, YAPFAQ will be measured at fixed times to determine pain intensity and limitations due to pain. Risk factors for prolonged pain and time needed until achieving discharge criteria from hospital will be reported.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing pectus excavatum repair with NUSS technique
* aged 12 years or above12
* informed consent signed for cryoanalgesia

Exclusion Criteria:

- Age of 11 years or below

* Refuse to receive cryoanalgesia or epidural catheter as primary pain relief
* Any contraindication to cryoanalgesia
* Difficult follow-up for geographical reasons and/or impossibility by the patient to understand how to perform self-measurements

Primary outcomes:
measure: Quality of Life by PedsQL 23 items
timeFrame: Two weeks after surgery
Secondary outcomes:
measure: YAPFAQ (Youth Acute Pain Functional Ability Questionnaire)
timeFrame: One week after surgery
measure: Pain by VAS
timeFrame: 1-14 days after surgery
measure: Thoracic hypo-aesthesia
timeFrame: Six months after surgery
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Istituto Giannina Gaslini
Study officials:
References:
citation: Arshad SA, Hatton GE, Ferguson DM, Li LT, Austin MT, Tsao K; PAPS SPONSOR. Cryoanalgesia enhances recovery from minimally invasive repair of pectus excavatum resulting in reduced length of stay: A case-matched analysis of NSQIP-Pediatric patients. J Pediatr Surg. 2021 Jul;56(7):1099-1102. doi: 10.1016/j.jpedsurg.2021.03.017. Epub 2021 Mar 24.
Clinical trial NCT05230420: Urine Bag Usage Versus Chest Drain Clamping After Lung Resection Surgeries
Official title: Urine Bag Usage Versus Chest Drain Clamping After Lung Resection Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pneumothorax and Air Leak
Pneumothorax
Pleura Injury
Pleural Effusion
Lead sponsor: Al-Quds University
Sponsor class: OTHER
Collaborators: name: Assiut University
name: Tanta University
name: European Institute of Oncology
First posted: 2022-02-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Investigators will compare two different approaches of postoperative drainage after the standard water-seal drain has been used efficiently; one is by using urine bag and check it get blown by the leaked air, two is by using clamping of the water seal drain. Investigators will compare them depending on several factors such as; cost effectiveness, hospital stay, duration of putting the drain and more, reinsertion of the chest tube and others.


Eligibility criteria: Inclusion Criteria:

* post lung resection patients (via Uniportal VATS only)
* Over the age of 18
* indicated chest tube

Exclusion Criteria:

* Under the age of 18

Primary outcomes:
measure: Overall cost
timeFrame: 5 to 6 days
Secondary outcomes:
measure: Number of participants with re-accumulation of air after chest tube clamping or attachment to the urine bag
timeFrame: up to 5 days
measure: total number of days with chest drain inserted
timeFrame: up to 5 days
measure: Number of chest x-rays
timeFrame: up to 5 days
measure: Number of participants that faced other intervention associated side effects
timeFrame: up to 5 days
measure: Number of participants with chest tube re-insertion
timeFrame: up to 5 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
city: Tanta
country: Egypt
facility: Tanta University
city: Milan
country: Italy
facility: European Institute of Oncology
city: Jérusalem-Est
country: Palestinian Territory, occupied
facility: Makassed Hospital
Study officials:
affiliation: Thoracic Surgery Unit, Makassed Islamic Charitable Society Hospital, Jerusalem, Palestine
name: Firas Abuakar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine
name: Osama Darras, MD candidate
role: STUDY_CHAIR
affiliation: Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine
name: Hadeel Abedalhameed, MD candidate
role: STUDY_CHAIR
affiliation: Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine
name: Rami Alaraj, MD candidate
role: STUDY_DIRECTOR
affiliation: Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine
name: Rania Attiyeh, MD candidate
role: STUDY_CHAIR
References:
Clinical trial NCT05006820: Epidemiology of Roller Hockey Related Injuries.
Official title: Epidemiology of Roller Hockey Related Injuries.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sports Injury
Keywords: Prevalence
Multidirectional Sport
Injury prevention
Athletic injuries
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 106
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Roller Hockey players playing in the spanish senior´s third division league

Brief summary: Roller Hockey is a sport played on a 40\*20 metres rink characterized by combined periods of high intensity and short breaks, there´s a lack of epidemiological studies in this field. In line with the well-established model of sports injury prevention research proffered by van Mechelen, the first stage in this process is establishing the extent of the problem i.e. injury incidence, severity and burden. Through an online survey filled by semiprofessional athletes, it is posible to obtain all this important information. This way, it will be possible to fulfill a gap in the literature and take action in the near future in order to reduce the prevalence of injuries in this sport.

Detailed description: A retrospective study was performed in male Roller Hockey players. 275 players will be recruited. Data of all injury along a whole season will be collected. Patients' information, including age, number of years playing, skill level and injured body part, will be analysed.

Eligibility criteria: Inclusion Criteria: Being a roller hockey player, play for one of the teams who participated in the 2020-2021 season third division league (Ok Liga Bronce). Play in at least one match in the season.

-

Exclusion Criteria: Being unable to understand the questionaire, do not accept on participating in the study.

-

Primary outcomes:
measure: Injury prevalence
timeFrame: September 2020-June 2021
Secondary outcomes:
measure: Injury burden
timeFrame: September 2020-June 2021
measure: Injury prevalence according to occurrence
timeFrame: September 2020-June 2021
measure: Injury prevalence by mechanism of injury
timeFrame: September 2020-June 2021
measure: Injury prevalence according to location
timeFrame: September 2020-June 2021
measure: Injury prevalence according to tissue affected
timeFrame: September 2020-June 2021
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hugo Olmedillas
state: Asturias
Study officials:
affiliation: Universidad de Oviedo
name: Hugo Olmedillas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00194220: Infertility Markers in Serum, Urine, and Follicular Fluid
Official title: Markers in Women Undergoing Infertility Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Infertility
Oxidative stress
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 1235
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing In vitro fertilization at the University of Pennsylvania

Brief summary: This study is only collecting specimens from current patients of PENN Fertility Care.

The purpose of this investigation is to assess if markers of oxidative stress that are known to be associated with other medical conditions can be detected in women undergoing infertility treatment and normal women of similar age. Oxidative stress may affect a woman's eggs or the follicular cells that surround and nurture them. Other markers of to be investigated include markers of cellular aging and DNA structural changes.

Presence of these markers will be compared in blood and urine samples taken during infertility treatment, and follicular fluid at the time of IVF (if applicable).


Eligibility criteria: Inclusion Criteria:

* Women aged 18-50
* Infertility patients only:

  1. Women undergoing infertility treatment (with or without in-vitro fertilization) at the University of Pennsylvania's PENN Fertility Care
  2. Verified infertility diagnosis of any of the following:

     * Endometriosis (minimal or mild)
     * Endometriosis (moderate or severe)
     * Tubal factor
     * Hypogonadotrophic hypogonadism
     * Polycystic ovary syndrome
     * Diminished ovarian reserve
     * Male factor
     * Unexplained
* Healthy normal volunteers only:

  1. Not undergoing infertility treatment
  2. Not using hormonal contraception

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Post-menopausal
* Concurrent participation in investigational trial
* Other health problems which, in the opinion of the investigator, may affect participation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Reproductive Research Unit
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kurt T Barnhart, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02314520: Complications Associated With Central Venous Access in the NSICU: PICC vs CVC
Official title: Complications Associated With Central Venous Access in the NSICU: PICC vs CVC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PICC
Central Venous Catheter
Central Line
Neuro ICU
Neuroscience ICU
CVC
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to determine whether Peripherally Inserted Central Catheter or Centrally Inserted Venous Catheters have lower complication rates in the Neuroscience Intensive Care Unit. After admission to the Neuroscience ICU and if they require central access, patients will be randomized to receive a PICC or CVC and complications (such as pneumothorax, deep venous thrombosis, infection, etc.) will be tracked and compared between the two interventions.


Eligibility criteria: Inclusion Criteria:

Adult patients admitted to the NSICU, who require central access for the treatment of their illness.

Exclusion Criteria:

1. Current or recent (within 1 month) diagnosis of bacteremia
2. Current or recent (within 1 year with confirmed resolution by imaging) deep venous thrombosis
3. Existing central access
4. Non-English speaking
5. Requirement for emergent central access and unable to obtain consent in an emergency setting

Primary outcomes:
measure: Participants With Complications With Central Access Including Insertion
timeFrame: up to 10 weeks
Secondary outcomes:
measure: Number of Participants With Deep Venous Thrombosis
timeFrame: up to 10 weeks
measure: Number of Patients With Complications Related to Insertion
timeFrame: From the time of insertion until first confirmatory chest X-ray
measure: Number of Participants With a Central Line Associated Blood Stream Infection
timeFrame: up to 10 weeks
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06443320: Evaluation of the Videodrama Therapeutic Device for Children With Autism Spectrum Disorders
Official title: Evaluation of the Videodrama Therapeutic Device for Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder (ASD)
Keywords: autism
videodrama
Lead sponsor: Centre Hospitalier Intercommunal Robert Ballanger
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Autism spectrum disorder (ASD) is a neurodevelopmental disorder (Valerie, Sperenza, 2009) that begins early in development, characterized by persistent deficits in communication and social interactions across various contexts and restricted, repetitive patterns of behavior, interests, or activities. These symptoms significantly impact social, school/professional functioning, or other important areas and are not better explained by intellectual disability or global developmental delay (American Psychiatric Association, 2013).

Detailed description: Currently, managing children with ASD emphasizes compensating for communication and social interaction disabilities. Communication tools like PECS or Makaton and social skills groups have shown effectiveness but have limitations, particularly not addressing sensory atypicalities seen in children with ASD. These sensory atypicalities are evident when children watch videos on screens. The idea is to use video to understand the sensory experiences of children with ASD and help them move away from an isolated relationship with screens. New technologies can further isolate children with ASD in their autistic sphere. The hypothesis is that observing these children with screens will provide better understanding of their sensory experiences and improve therapeutic support towards play and interaction with others

Eligibility criteria: Inclusion Criteria:

* Children aged 3 to 15 years.
* Clinically confirmed ASD by a psychiatrist.
* Parental or legal guardian consent for participation.
* Child showing a strong interest in screens and/or video content.
* Ability to tolerate the presence of other children.
* Minimum of 18 video drama sessions.
* Not having benefited from disease care in the past.
* Affiliation to a social security system

Exclusion Criteria:

* No ASD diagnosis.
* Younger than 3 or older than 15 at the study start.
* No interest in screens or video content.
* Parental or legal guardian refusal for participation.
* Dropping out before completing 18 sessions.
* Patient having benefited a disease care in the past

Primary outcomes:
measure: Dunn Sensory Profile questionnaire
timeFrame: 9 months
Secondary outcomes:
measure: Cars-T questionnaire
timeFrame: 9 months
measure: Sceno Test
timeFrame: 9 months
Other outcomes:
Locations:
city: Aulnay-sous-Bois
country: France
facility: CHI Robert Ballanger
Study officials:
References: