louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04986553: A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of Clavicle Plates
Official title: A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of Clavicle Plates
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Clavicle Fracture
Lead sponsor: Arthrex, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Arthrex Clavicle Plates are intended to be used in the general population for clavicle fractures.

Brief summary: The objective of the registry is to evaluate the continued safety and performance of Arthrex Clavicle Plates used to treat clavicle fractures.

Detailed description: To assess safety, device-related adverse events will be reported and evaluated over the course of the study. To evaluate the performance imaging of the target area will be evaluated at three months postoperative. Additionally, patient-reported outcomes will be evaluated at three months postoperative, 6 months postoperative, and one year postoperative using the Visual Analogue Scale (VAS), Veterans Rand 12-Item Health Survey (VR-12), and American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES).

Eligibility criteria: Inclusion Criteria:

1. The subject requires surgery using the Arthrex Clavicle Plate for clavicle fracture.
2. The subject is 18 years of age or over.
3. The subject is not considered a vulnerable subject (i.e., child, pregnant, nursing, prisoner, or ward of the state).
4. Subject signed informed consent and is willing and able to comply with all study requirements

Exclusion Criteria:

1. Insufficient quantity or quality of bone.
2. Blood supply limitations and previous infections, which may retard healing.
3. Foreign-body sensitivity.
4. Any active infection or blood supply limitations.
5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
6. Subjects that are skeletally immature.

Primary outcomes:
measure: To assess a change in Visual Analogue Scale (VAS) survey
timeFrame: Preoperatively, 3 months, 6 months and 12 months postoperatively
measure: To assess a change in Veterans Rand 12-Item Health Survey (VR-12)
timeFrame: Preoperatively, 3 months, 6 months and 12 months postoperatively
measure: To assess a change in American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
timeFrame: Preoperatively, 3 months, 6 months and 12 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Sierra Pacific Orthpaedic CenterMedical Group, Inc
state: California
city: Golden
country: United States
facility: Panorama Orthopedics & Spine Center, PC
state: Colorado
Study officials:
References:
Clinical trial NCT03039153: Pressure Ulcers in Knee Replacement Surgery
Official title: The Peripheral Nerve Blocks Analgesia in Patients Undergoing Knee Replacement Surgery is a Risk Factor for the Development of Pressure Sores at the Heel? Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Pressure Ulcer
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 565
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing knee replacement surgery following chronic joint disease

Brief summary: From the point of view of nursing to know exactly the different risk factors for the onset of pressure ulcers is very important as it allows to accurately orient preventive care interventions.

All the variable that could influence the development of pressure ulcer in patients undergoing knee replacement surgery are identified and collected: age, sex, body max index, risk to develop Pressure Ulcer (braden score), treatment to prevent pressure ulcers (typology of the devices used, such as air mattresses with alternating or static pressure, heel drains, frequency of mobilization carried out by both the patient care), management of eventual incontinence (use of diapers, urinary catheter), type of anesthesia, type of analgesia, length of stay, the ASA physical status classification system (ASA score), comorbidity, cancer, use of devices for controlling the position of the operated limb (foam valve), the number of physical therapy sessions actually carried out.


Eligibility criteria: Inclusion Criteria:

* Primary knee joint replacement
* Secondary knee joint replacement

Exclusion Criteria:

* Cancer patients
* Adult or Senior with pressure ulcer at the heel

Primary outcomes:
measure: Heel Pressure Sores
timeFrame: every day until discharge (expected average of 6 days).
Secondary outcomes:
measure: Heel Pressure Sores of grade ≥2
timeFrame: every day until discharge (expected average of 6 days).
measure: Pressure Sores in any other site
timeFrame: every day until discharge (expected average of 6 days).
measure: Pain
timeFrame: up to the first 3 days post intervention
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Gianfranco Ferrarelli, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04210453: The Impact of Vitamin C on Postoperative Acute Kidney Injury in Risk Patients Undergoing Valvular Heart Surgery
Official title: The Impact of Vitamin C on Postoperative Acute Kidney Injury in Risk Patients Undergoing Valvular Heart Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Kidney Injury
Keywords: Postoperative acute kidney injury
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 264
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are divided into 2 groups, who are administered IV Vitamin C or who are administered IV normal saline.
Primary purpose: PREVENTION

Brief summary: In cases of cardiac surgery or sepsis which cause inflammation, oxidative stress, endothelial injury and vasoplegia, serum vitamin C concentration is sharply decreased. The anti-inflammatory and anti-oxidant effects of vitamin C and the effects of reducing vasoconstrictor use have been demonstrated in patients with sepsis and septic shock, however, the foregoing effects have not been validated in patients undergoing cardiac surgery.

In this study, investigators investigate the effect of intravenous vitamin C on the incidence of acute renal injury after valvular heart surgery.


Eligibility criteria: Inclusion Criteria:

* Patients older than 20 years and undergoing elective valvular heart surgery whose preoperative acute renal failure score is ≥3 (moderate to severe risk).

Exclusion Criteria:

* Emergency operation
* Cardiogenic shock or ventricular-assist device (eg. ECMO, IABP)
* Severe chronic kidney disease (GFR(CKD-EPI) \<30ml/min/1.73m2)
* Patients with past history of gout or renal stone or hyperoxaluria or cystinuria
* Hemolytic anemia due to pyruvate kinase deficiency or glucose-6-phosphate dehydrogenase deficiency
* Sicklemia or thalassemia
* Hemochromatosis
* Allergy to disodium ethylenediamine-tetraacetate or ascorbic acid
* Patients taking aspirin up to 3 days before surgery
* Patients taking antiepileptic drug or fluphenazine or steroid
* Patients taking vitamin C within a month of surgery
* Pregnant or lactating women
* Patients who cannot understand the informed consent (eg. Foreigner)

Primary outcomes:
measure: Postoperative acute kidney injury
timeFrame: Postoperative 7 days
Secondary outcomes:
measure: Postoperative oxidative stress and vascular injury(Comparing the serum concentration)
timeFrame: Before anesthetic induction (Baseline)
measure: Postoperative oxidative stress and vascular injury(Comparing the serum concentration)
timeFrame: 5 minute after CPB cessation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT05979753: Effects Of High Intensity Interval Training On Speed And Explosive Strength In Sprinters
Official title: Effects Of High Intensity Interval Training On Speed And Explosive Strength In Sprinters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sprinters
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: High Intensity Interval Training (HIIT) is a type of exercise that alternates between short bursts of high and low intensity activity. The physical components may be improved very effectively and efficiently with this kind of training. The choice of an effective practice strategy could be very beneficial because boosting an athlete's performance is correlated with improving their physical components. The significance of this study was that HIIT is helpful in increasing strength, endurance and agility. Thus it could be useful for athletes for their physical fitness in less duration as compared to the conventional protocols.

Detailed description: According to researchers knowledge there is lack of sufficient literature on "The Effect Of High Interval Intensity Training On Speed And Explosive Strength In Sprinters." The past trials do not address speed and strength in relation to HIIT and this study will help identify the need to practice this training in order to enhance the skills and athletic performance of sprinters and will uplift their anaerobic fitness.

Eligibility criteria: Inclusion Criteria:

* Age ranging from 18 to 30 years
* Actively competing in races
* Had professional sprinting experience of one year
* Both genders included.
* Athletes who have clean bill of health for past 6 months
* Never engaged in a high intensity training program

Exclusion Criteria:

* Any Neuromuscular issue like myopathy, peripheral neuropathy and multiple sclerosis
* Any Musculoskeletal issue like chronic low back pain, tendinopathies, disc slips and OA
* Pregnancy
* Athlete who is on any kind of medications

Primary outcomes:
measure: High Intensity Interval Training
timeFrame: 6 Months
measure: Conventional Exercises
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pakistan Sports Board
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sidra Shafique
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01596153: Probiotics in Hospitalized Patients Study
Official title: Randomized Double-blind, Placebo-Controlled Trial Comparing the the Effect of Enhance Probiotic (EP, Go Live Rx,) Versus Placebo (Pl) on the Incidence of Clostridium Difficile Associated Diarrhea (CDAD) or Antibiotic-Associated Diarrhea (AAD)in Hospitalized Patients Initiated on Antibiotics
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Antibiotic Associated Diarrhea
Clostridium Difficile Associated Diarrhea
Lead sponsor: South Shore Hospital
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare the effect of enhanced probiotic (EP, Live Rx) versus placebo (PL) on the incidence of Clostridium difficile associated diarrhea (CDAD) or antibiotic associated diarrhea (AAD) in hospitalized patients initiated on antibiotics.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older admitted to SSH and prescribed antibiotics for an expected duration \>3 days (may include patients on antibiotics prior to admission).

Exclusion Criteria:

* 1. History of chronic diarrhea illness (Irritable Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), Celiac Disease, Chronic pancreatitis 2. Diarrhea at screening 3. Active Colitis of any etiology 4. History of colectomy 5. Regular consumption of probiotics within 72 hours 6. Unable to provide written consent 7. History of or active pancreatitis 8. Severe Sepsis or Septic Shock (sepsis with end organ failure e.g. renal failure, ARDS, MS changes and or meets criteria by n ational guideline, and or requiring vasopressors) 9. Hypersensitivity to any ingredient in probiotic product 10. Severe Immunosuppression (ANC \<1000, AIDS/CD4 count \<200 cells, cancer on active chemothereapy, h/o of solid or bone marrow transplant) 12. Acute burn injuries

Primary outcomes:
measure: Incidence of Clostridium difficle associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo
timeFrame: 60 days after hospitalization
Secondary outcomes:
measure: Incidence of Antibiotic associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo
timeFrame: 60 Days after hospitalization
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03197753: Postoperative Discomfort After Dental General Anesthesia
Official title: Postoperative Discomfort and Emergence Delirium In Children Receiving Dental Treatment Under General Anesthesia: Comparison Of Nasal Tracheal Intubation and Laryngeal Mask Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: laryngeal mask airway
nasotracheal intubation
dental treatment
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel
Primary purpose: PREVENTION

Brief summary: The aim of this prospective, randomised, controlled clinical trial was to compare immediate postoperative discomfort, emergence delirium and recovery time of the patients intubated using either laryngeal mask airway or nasotracheal intubation.

Detailed description: A total of 70 children aged 3 to 7 years received full mouth dental rehabilitation under general anesthesia. Children were randomly grouped into Laryngeal mask airway (LMA) group (n=35) and nasotracheal intubation (NTI) groups (n=35). In LMA group LMA was inserted after anesthesia induction using 8% sevoflurane. In NTI group rocuronium and remifentanil were given intravenously during %8 sevoflurane induction and the patients were intubated by a nasotracheal tube. After completion of the dental treatments patients were transferred to the post anesthesia care unit (PACU). Duration of dental operation ,duration of anesthesia, recovery time, postoperative discomfort, emergence delirium, pediatric dentist's access were recorded.

Eligibility criteria: Inclusion Criteria:

* Aged 3-7 years,
* ASA I and II
* Lack of chairside cooperation for dental treatment in clinical setting.

Exclusion Criteria:

* A history of of anticipated difficult entubation ,
* Patient with pharyngeal pathology patients with known pulmonory or cardiovascular disease,
* When the expected dental procedure was more than two hours
* Mental retardation and those whose parents did not consent to their participation in the study.

Primary outcomes:
measure: Postoperative discomfort
timeFrame: Postoperative 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Sultan Keles
state: Efeler
Study officials:
affiliation: Aydin Adnan Menderes University
name: Sultan KELES, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hung WT, Chen CC, Chau MY, Tsai WY. Effect of reinforced laryngeal mask airway or endotracheal intubation anesthesia on adverse events: quality of life issues for dental patients requiring general sedation. Spec Care Dentist. 2005 Jul-Aug;25(4):188-92. doi: 10.1111/j.1754-4505.2005.tb01648.x.
citation: Zhao N, Deng F, Yu C. Anesthesia for pediatric day-case dental surgery: a study comparing the classic laryngeal mask airway with nasal trachea intubation. J Craniofac Surg. 2014 May;25(3):e245-8. doi: 10.1097/SCS.0000000000000547.
Clinical trial NCT02853253: Rate of Bronchopulmonary Dysplasia in Preterms Neonates: a Trial Comparing SMOFlipid and Medialipide
Official title: Rate of Bronchopulmonary Dysplasia in Preterms Neonates Less Than 29 Weeks' Gestational Age and / or With Birth Weight Less Than 1000 g: a Double Blind Randomized Controlled Multicenter Trial Comparing SMOFlipid and Medialipide
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Preterm Neonates
Keywords: Preterm neonates
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: SMOF is a large double blind placebo-controlled randomized clinical trial aiming to compare the rate of bronchopulmonary dysplasia (BPD) at 36 weeks corrected age in premature infants \< 29 weeks and / or with birth weight \< 1000 g receiving either SMOFlipid® or Medialipide® 20%. This study will offer new information for optimizing the management of preterms requiring parenteral nutrition. The investigators hypothesis is that the composition of SMOFlipid may decrease lipid peroxidation and oxidative stress in preterms, resulting in a lower incidence of BPD.


Eligibility criteria: Inclusion Criteria:

* Preterm neonates with gestational age \< 29 weeks and / or birth weight \< 1000 g
* Admission in the Intensive Care Unit within 6 h after birth
* IV Lipid Emulsion (LE) started latest at first day of life
* Anticipated duration of Parenteral Nutrition \>10 days
* Informed consent from legal representative

Exclusion Criteria:

* Inherited metabolic diseases
* Major congenital malformations
* Participation to another study evaluating any kind of medications

Primary outcomes:
measure: Rate of other free radical diseases
timeFrame: 36 weeks corrected age
Secondary outcomes:
measure: Weight gain
timeFrame: at day 28
measure: Weight gain
timeFrame: week 36 corrected age
measure: Growth velocity
timeFrame: at day 28
measure: Growth velocity
timeFrame: week 36 corrected age
measure: Head circumference growth velocity
timeFrame: at day 28
measure: Head circumference growth velocity
timeFrame: at week 36 corrected age
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Femme Mère Enfant
Study officials:
affiliation: Hospices Civils de Lyon
name: Olivier CLARIS, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04213053: Lees Screen in Concomitant Strabismus
Official title: Changes in Range of Ocular Motility Following Horizontal Rectus Muscle Surgery in Concomitant Strabismus; a Quantitate Measurements Using Lees Screen
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Strabismus
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: detect if there are any change in motility after concomitant horizontal muscle surgery
Primary purpose: DIAGNOSTIC

Brief summary: Preoperative and postoperative Lees screen was done after concomitant horizontal strabismus surgery to detect any limitation in the field of operated muscle

Detailed description: Preoperative and postoperative Lees screen was done for concomitant esotropia and exotropia patients to record any change in ocular motility as regards underaction or overaction in the operated extra ocular muscles

Eligibility criteria: Inclusion Criteria:

* Concomitant esotropia
* Concomitant exotropia
* Above 10 years old patients

Exclusion Criteria:

* Restrictive and paralytic strabismus
* Previous strabismus surgery
* Mental disability

Primary outcomes:
measure: postoperative Lees screen
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine
state: Minia
Study officials:
affiliation: Minia University
name: Sahar TA Abdelaziz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05834153: Effects of Kinesiotaping and Electrical Muscle Stimulation on Low Back Pain and Disability
Official title: Comparative Effects of Kinesiotaping and Electrical Muscle Stimulation on Low Back Pain and Disability Associated With Diastasis Recti
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: kinesiotaping
electrical muscle stimulation
low back pain
diastasis recti
exercises
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 48
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of kinesiotaping and electrical muscle stimulation on low back pain and disability associated with diastasis recti.


Eligibility criteria: Inclusion Criteria:

* Diastasis recti more than 2 or 2.5cm
* 6 weeks' postpartum cesarean section females
* Primigravida females
* Low back pain due to DR

Exclusion Criteria:

* Normal vaginal delivery
* Episiotomy
* Multigravida women's
* History of abdominal hernia
* History of any abdominal surgery

Primary outcomes:
measure: Numeric pain rating scale
timeFrame: 4th week
measure: Manual muscle testing MMT
timeFrame: 4th week
measure: Roland Morris Disability Questionnaire (RMDQ) for disability
timeFrame: 4th week
measure: Caliper method
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Gujranwala
country: Pakistan
facility: DHQ hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: hina gul, MSOMPT
role: PRINCIPAL_INVESTIGATOR
References: