louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01704924: Prospective Observation of Wound Healing With Prevena Incision Management System
Official title: Prospective Observation of Wound Healing With Prevena Incision Management System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Scarring
Keywords: Prevena
negative pressure wound therapy
Incisional wound vac
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to assess the quality of wound healing in abdominal scars with and without the Prevena Incision Management System. The hypothesis is that Prevena will lead to improved wound healing with less swelling, bruising, and inflammation, as well as less potential for infection, seroma, and dehiscence.

Detailed description: The quality of wound healing can be of the utmost importance for patients undergoing large abdominal surgery. Incisional negative pressure wound therapy has been observed to decrease seroma and infection rates in high risk patients. This study aims to quantify the effect, if any, that negative pressure wound therapy has on closed incisions. The technology may provide benefits even in lower risk patients.

Eligibility criteria: Inclusion Criteria:

* abdominal procedure with incision \>20cm
* must be \>18 years of age

Exclusion Criteria:

* \<18 years of age
* history of allergy or reaction to adhesives
* pregnant or anticipated pregnancy within 6 months

Primary outcomes:
measure: Scarring
timeFrame: 0-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California at Irvine
state: California
Study officials:
affiliation: The University of California Irvine
name: Gregory Evans, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pachowsky M, Gusinde J, Klein A, Lehrl S, Schulz-Drost S, Schlechtweg P, Pauser J, Gelse K, Brem MH. Negative pressure wound therapy to prevent seromas and treat surgical incisions after total hip arthroplasty. Int Orthop. 2012 Apr;36(4):719-22. doi: 10.1007/s00264-011-1321-8. Epub 2011 Jul 15.
citation: Stannard JP, Volgas DA, McGwin G 3rd, Stewart RL, Obremskey W, Moore T, Anglen JO. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma. 2012 Jan;26(1):37-42. doi: 10.1097/BOT.0b013e318216b1e5.
Clinical trial NCT06851624: Six Months Follow-up of Two and Four Mini Screws Supported Hyrax in Adults
Official title: Six Months Follow-up of Two and Four Mini Screws Supported Hyrax for Maxillary Expansion in Non-growing Patients: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transverse Maxillary Deficiency
Keywords: expansion,posterior crossbite
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two experimental groups ,two screw supported and four screw supported hyrax
Primary purpose: TREATMENT

Brief summary: six months follow-up of two and four mini-screw supported hyrax for maxillary expansion in non-growing patients: A randomized controlled clinical trial

Detailed description: transverse malocclusion is very common in adult ,using conventional hyrax expander has many limitations and side effects such as buccal tipping, marginal bone loss, dento aloveolar expansion.

in such cases , surgically assisted rapid palatal expansion used to be the option of choice ,due to the invasiveness of the procedure and co-morbidity associated with it ,minis crews assisted rapid expansion is recently introduced to overcome the complications of both convectional and surgically assisted rapid palatal expansion

Eligibility criteria: Inclusion Criteria:

* adults male or female aged from 18-30 years with skeletal Maxillary constriction.
* unilateral or bilateral Dental posterior cross-bite.
* mid-palatal suture maturation (Grade C, D) according to F Angileri classification.
* good oral hygiene,

Exclusion Criteria:

* no functional crossbite due to premature contacts.
* no previous orthodontic treatment.
* no buccal crossbite.
* no craniofacial anomalies or syndromes

Primary outcomes:
measure: Skeletal effects
timeFrame: 6-8 months
Secondary outcomes:
measure: Dento-alveolar effects
timeFrame: 6-8 months
measure: Dento-alveolar effects
timeFrame: 6-8 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: 11,ElSaraya street ,Almanyal ,CAIRO ,EGYPT
Study officials:
affiliation: Associate proff
name: fady hussein fahim, PhD
role: STUDY_DIRECTOR
affiliation: lecturer
name: nada omar elzawahry, PhD
role: STUDY_DIRECTOR
affiliation: MSc candidates
name: elzubair osman salih, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT00589524: Comparison of Coronary CT With IVUS in Heart Transplant Population
Official title: Comparison of Non-invasive Coronary CT With IVUS for the Detection of Coronary Artery Vasculopathy in a Cardiac Transplant Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Transplantation
Keywords: blocked arteries
narrowing arteries
IVUS
CT
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To compare results of Intravascular Ultrasound (which occurs during cardiac catheterization) with Computed Tomography (CT) scan to detect blockages or narrowing of the arteries that feed the heart. These will be studied in the cardiac transplant population.


Eligibility criteria: Inclusion Criteria:

* Heart transplant patients coming to the Cardiac Cath Lab for their yearly angiogram which includes intravascular ultrasound (IVUS)

Exclusion Criteria:

* Patients with a history of allergic reactions to contrast material Creatine \>1.5 Clinical or hemodynamic instability Those who are unable to consent for enrollment into the study

Primary outcomes:
measure: To determine if Computed Tomography (CT) of the arteries that feed the heart is more sensitive than Intravascular Ultrasound (IVUS) which is performed during cardiac catheterization
timeFrame: within 3 months of cardiac cath with IVUS
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04368624: PKU Skin Stripping
Official title: A Novel Approach Integrating Non-invasive Skin Tape-stripping to Evaluate and Monitor Patients With Phenylketonuria (PKU)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phenylketonurias
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: BioMarin Pharmaceutical
First posted: 2020-04-30
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Phenylketonuria (PKU) is a serious metabolic disorder characterized by intolerance to the dietary intake of phenylalanine. When untreated, older children can show the following clinical manifestations: microcephaly, epilepsy, a musty body odor, decreased skin and hair pigmentation, eczema, severe intellectual disability, and behavioral problems.

Brief summary: PURPOSE OF STUDY: To determine if a non-invasive skin stripping technique can be used to detect individuals with phenylalanine abnormalities, and to monitor dietary and/or drug effects over time.

Detailed description: This study will determine if a non-invasive skin stripping technique can be used to detect individuals with phenylalanine abnormalities, and to monitor dietary and/or drug effects over time. To do this 50 children and adults with phenylalanine abnormalities and up to 50 unaffected controls will be recruited to this study. The 50 affected individuals will have their metabolomic profile analyzed from up to 3 skin-stripping samples over time and compared to their serum amino acid profile in both dried blood spots and a typical blood sample. The unaffected controls will provide one skin-stripping sample. Clinical data regarding compliance with dietary therapy and other medications will be collected to determine other effects on the metabolome.

Eligibility criteria: Inclusion Criteria:

1. A clinical diagnosis of PKU that is confirmed by elevated serum phenylalanine.
2. Any age.
3. Subject or the subject's legal authorized representative has given written informed consent to participate in the study.

Exclusion Criteria:

* Not applicable.

Primary outcomes:
measure: Control Metabolomic Profile (skin)
timeFrame: 5 years
measure: PKU Metabolomic Profile (skin)
timeFrame: 5 years
measure: Metabolomic Profile Change
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Carlos E Prada, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holleran WM, Ziegler SG, Goker-Alpan O, Eblan MJ, Elias PM, Schiffmann R, Sidransky E. Skin abnormalities as an early predictor of neurologic outcome in Gaucher disease. Clin Genet. 2006 Apr;69(4):355-7. doi: 10.1111/j.1399-0004.2006.00589.x. No abstract available.
Clinical trial NCT01827124: Randomized Clinical Trial for Comparison Of Intravenous Carbeitocin Versus Oxytocin In Management Of Placental Delivery In Second Trimester Interruption
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: CARBETOCIN FOR PREVENTION OF PLACENTAL RETAINED
Keywords: CARBETOCIN AND OXYTOCIN AND SECOND TRIMESTER INTERRUPTION
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Ain Shams Maternity Hospital
First posted: 2013-04-09
Enrollment: 140
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Intravenous Carbetocin is more efficient than intravenous infusion oxytocin in management of placental delivery in 2nd trimester interruption.


Eligibility criteria: Inclusion Criteria:

* Age:16-50 years
* Pregnancy duration: 14-24weeks
* Spontaneous abortion or medical induced abortion at 14-24weeks

Exclusion Criteria:

* Age less than 16years and more than 50 years
* Surgical termination
* Placenta previa
* Uterine fibroid

Primary outcomes:
measure: Record duration of spontaneous placental expulsion after delivery of fetus in second trimester interruption
timeFrame: at the time of delivery
Secondary outcomes:
measure: Estimation of blood loss in each group by weighing all pads put under the patient after delivery of fetus tell expulsion of placenta( before and after using of pads).
timeFrame: at time of delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university maternity hospital department of obstetrics and gynacology
state: Tertiary
Study officials:
References:
Clinical trial NCT03998124: Peer Intervention for Social Skills (Brain Injury)
Official title: A Peer-led Intervention for Social Communication Skills Following Brain Injury (Main Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An experimental parallel group design
Primary purpose: TREATMENT

Brief summary: To investigate the effectiveness of a peer-led group intervention compared to a staff-led activity group to improve social communication skills for people with severe acquired brain injury (ABI).

Detailed description: An earlier pilot study tested the feasibility of the approach and the sensitivity of existing outcome measures to changes in group social interaction (NCT02211339). Following amendments to the pilot study protocol, twelve new participants with severe ABI were recruited from a residential post-acute rehabilitation centre. An experimental parallel group design was used to compare a peer-led group intervention to a staff-led social activity group. Participants were randomised to a peer-led intervention (n=6) or a staff-led social activity group (usual care) (n=6). The groups met twice a week for 8 weeks. A peer with severe ABI was trained separately to facilitate interaction the peer-led group. The training took place in 16 individual sessions over 4 weeks. Group behaviour was measured twice at baseline, after intervention and at maintenance (4 weeks) using measures meeting reliability, validity and responsiveness criteria tested in the pilot study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of severe traumatic brain injury (TBI) or severe ABI with similar cognitive presentation to TBI
* Minimum of 6 months post injury
* Evidence of social communication impairment as a result of injury
* Ability to tolerate group activity

Exclusion Criteria:

* Significant aphasia
* Severe depression or psychiatric disorder
* Insufficient English to converse with peer
* Profound cognitive impairment

Primary outcomes:
measure: The Adapted Measure of Participation in Conversation (MPC): Interaction Scale
timeFrame: Baseline to maintenance (week 12)
measure: The Adapted Measure of Participation in Conversation (MPC): Transaction Scale
timeFrame: Baseline to maintenance (week 12)
measure: The Interactional Network Tool (INT)
timeFrame: Baseline to maintenance (week 12)
Secondary outcomes:
measure: La Trobe Communication Questionnaire (self-report)
timeFrame: Baseline to maintenance (week 12)
measure: La Trobe Communication Questionnaire (other-report)
timeFrame: Baseline to maintenance (week 12)
Other outcomes:
Locations:
Study officials:
affiliation: University College, London
name: Suzanne Beeke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02730624: Piperacillin/Tazobactam in Critically Ill Patients With Severe Sepsis and Septic Shock
Official title: Population Pharmacokinetics and Pharmacodynamics Study of Piperacillin/Tazobactam During Early Phase in Critically Ill Patients With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Early Phase of Severe Sepsis and Septic Shock
Keywords: piperacillin/tazobactam
critically ill
severe sepsis
septic shock
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
Collaborators: name: Prince of Songkla University
First posted: 2016-04-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is prospective study to assess the pharmacodynamics (t\>MIC) of 4.5 g every 6 h of piperacillin/tazobactam in patients with early phase of severe sepsis/septic shock following administration by a 30 min infusion.

Clinical and laboratory data such as age, sex, body weight, electrolyte, vital signs, APACHAE II score, BUN, Cr and fluid balance will be collected.

Fifty patients will be enrolled in this study. Piperacillin pharmacokinetic study will be carried out during the piperacillin/tazobactam therapy.

Each patient received 4.5 g every 6 h of piperacillin/tazobactam within 24 h of severe sepsis or septic shock, blood samples (approximately 3 ml) will be obtained by direct venipuncture at the following time: 0, 0-0.5, 0.5-2, 2-4 and 4-6 h after piperacillin/tazobactam therapy.

Concentration of piperacillin in plasma will be simulated in Monte Carlo technique to get PK/PD index and reported to % PTA and % CFR.


Eligibility criteria: Inclusion Criteria:

* sepsis patient (defined by 2011 SCCM/ESICM/ACCP/ATS/SIS International sepsis definition conference)
* severe sepsis or septic sock was defined by

  * Severe sepsis (sepsis with organ dysfunction)
  * Septic shock (sepsis with systolic arterial pressure\<90 mmHg, mean arterial pressure\<60 mmHg or decrease systolic blood pressure\> 40 mmHg from base line)

Exclusion Criteria:

* Patients who are pregnant.
* Patients who have documented hypersensitivity to beta-lactam
* Patients who are dialysis
* Patients who are severe sepsis or septic shock more than 24 hour

Primary outcomes:
measure: Concentration of piperacillin in plasma
timeFrame: 6 hour after the piperacillin dose
Secondary outcomes:
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
state: Songkla
Study officials:
References:
Clinical trial NCT01730924: Comparison of Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data
Official title: A Randomised Study Comparing Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data. The SMART Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Atrial Fibrillation Ablation
Pulmonary Vein Isolation
Keywords: Atrial fibrillation
Contact force
Ablation
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The most widely used approach for the invasive treatment of paroxysmal atrial fibrillation is catheter ablation, by which radiofrequency energy is used to heat the tip of an ablation catheter to deliver targeted burns on the inner surface of the heart. The aim of this approach is to cause electrical isolation of the pulmonary veins. The purpose of this study is to evaluate whether the information which can be derived from the latest catheter technologies - on the degree of contact force between the catheter and the heart - affects the time to perform the procedure, or the outcomes as a result of it. Patients undergoing pulmonary vein isolation will be randomised to having their procedure performed with the contact force information available to the operator, or not available. The time taken to achieve pulmonary vein isolation is the primary end-point of the study.


Eligibility criteria: Inclusion Criteria:

Age \> 18 years, Symptomatic paroxysmal atrial fibrillation (defined as ECG proven episodes of atrial fibrillation which are self limiting and last less than 7 days on each occasion)

Exclusion Criteria:

Inability or unwillingness to receive oral anticoagulation Previous ablation procedure for atrial fibrillation Unwillingness or inability to complete the required follow up arrangements Persistent atrial fibrillation Prior prosthetic mitral valve replacement or severe structural cardiac abnormality Known severe left ventricular systolic function (ejection fraction \<35%) Known hypertrophic or infiltrative cardiomyopathy

Primary outcomes:
measure: Time to achieve pulmonary vein isolation in patients undergoing catheter ablation for paroxysmal atrial fibrillaiton
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust
Study officials:
References:
citation: Ullah W, McLean A, Tayebjee MH, Gupta D, Ginks MR, Haywood GA, O'Neill M, Lambiase PD, Earley MJ, Schilling RJ; UK Multicentre Trials Group**. Randomized trial comparing pulmonary vein isolation using the SmartTouch catheter with or without real-time contact force data. Heart Rhythm. 2016 Sep;13(9):1761-7. doi: 10.1016/j.hrthm.2016.05.011. Epub 2016 May 9.
Clinical trial NCT06448624: Biomarkers & Infection After Prophylactic Antibiotic in Cardiac Implantable Electronic Device Implantation
Official title: Effect of Single Dose & Intrapocket Prophylactic Antibiotic to Cardiac Implantable Electronic Device-related Infection & Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Block
CIED Related Infection
CIED-related Infections
Antibiotic Prophylaxis
Biomarkers
Keywords: heart block
CIED related infection
antibiotic prophylaxis
biomarkers
Lead sponsor: Universitas Diponegoro
Sponsor class: OTHER
Collaborators: name: Dr. Kariadi General Hospital Medical Center
First posted: 2024-06-07
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized controlled trial
Primary purpose: PREVENTION

Brief summary: Effect of single dose \& intrapocket prophylactic antibiotic to cardiac implantable electronic device-related infection \& biomarkers


Eligibility criteria: Inclusion Criteria:

* Indication of CIED implantation
* No infection at the time of implantation

Exclusion Criteria:

* Refuse to participate in the study
* Allergy to ampicillin sulbactam
* CIED debridement

Primary outcomes:
measure: Incidence of CIED-related infection
timeFrame: Baseline, 3 days, 7 days, and 28 days
Secondary outcomes:
measure: Level of Presepsin
timeFrame: Baseline and 24 hours after CIED implantation
measure: Level of Interleukin-6
timeFrame: Baseline and 24 hours after CIED implantation
measure: Level of Procalcitonin
timeFrame: Baseline and 24 hours after CIED implantation
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Kariadi Central General Hospital
state: Central Java
Study officials:
References: