louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02355691: Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty
Official title: Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Complications; Arthroplasty, Infection or Inflammation
Wound Complication
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Kinetic Concepts, Inc.
First posted: 2015-02-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For the target population of adult patients following primary total hip arthroplasty, the randomized clinical trial will be used to evaluate the efficacy of the use of a mobile negative pressure wound therapy(NPWT) device compared to a standard absorptive dressing in the immediate postoperative period. We will apply two dressing types and evaluate the postoperative wounds with a wound scoring system (ASEPSIS) that incorporates multiple variables of wound infection risk.


Eligibility criteria: Inclusion Criteria:

- Adult patients undergoing primary total hip arthroplasty.

Exclusion Criteria:

* age less than 18 y/o
* Total hip arthroplasty for fracture
* Revision or conversion total hip arthroplasty
* inability to personally consent to participation due to cognitive impairment, intoxication or sedation
* multiple surgical procedures
* Patients taking immune modulating medication(prednisone, methotrexate, anakinra, etc.)
* skin hypersensitivity to acrylic adhesive or silver.
* Inability to care for dressing due to physical or mental incapacitation

Primary outcomes:
measure: Mean Wound Healing Scores by the ASEPSIS Criteria
timeFrame: (Single point evaluation)-2 weeks post surgery visit
Secondary outcomes:
measure: Number of Participants With Infection
timeFrame: (Single point evaluation)-6 weeks post surgery visit
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Orthopaedics
state: North Carolina
Study officials:
affiliation: UNC Orthopaedics
name: Daniel J Del Gaizo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03849391: Effect of Skate Skin Extract on Cognitive Function in Adults
Official title: Effect of Skate Skin Extract on Cognitive Function in Adults With Subjective Memory Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Memory Impairment
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Skate Skin extract on cognitive function in adults with subjective memory impairment for 12 weeks.

Detailed description: Previous animal studies have indicated that Skate Skin extract may have the ability to improve cognitive function. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Skate Skin extract on cognitive function in adults with subjective memory impairment for 12 weeks; the safety of the compound are also evaluate. The Investigators examine chemical and metabolic parameters, and cognitive function at baseline, as well as after 6 and 12 weeks of intervention. One hundred adults were administered either 500 mg of Skate Skin extract or a placebo each day for 12 weeks;

Eligibility criteria: Inclusion Criteria:

* Global Deterioration Scale (GDS) 2 or 3

Exclusion Criteria:

* Abnormal liver or renal function (i.e., serum aminotransferase activity \> 3 times of upper limit of reference range and serum creatinine concentrations \> 1.2 mg/dL)
* Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL)
* History of viral hepatitis or cancer
* Uncontrolled hypertension
* History of serious cardiac disease such as angina or myocardial infarction
* History of gastrectomy
* History of medication for psychiatric disease
* Administration of oriental medicine including herbs within the past 4 weeks

Primary outcomes:
measure: Mini-Mental State Examination total score
timeFrame: Change from Baseline Mini-Mental State Examination total score at 3 months
Secondary outcomes:
measure: Korean instrumental activity of daily living total score
timeFrame: Change from Baseline Korean instrumental activity of daily living total score at 3 months
measure: Computerized NeuroCognitive Function test total score
timeFrame: Change from Baseline Computerized NeuroCognitive Function test total score at 3 months
measure: brain derived neurotrophic factor
timeFrame: Change from Baseline brain derived neurotrophic factor level at 3 months
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Integrated Research Institute for Natural Ingredients and Functional Foods
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01796691: The Bochum Optimizing Clopidogrel-Aspirin Therapy and MORTality Study (BOCLA-Mort)
Official title: Optimized Antiplatelet Therapy With Aspirin and Clopidogrel Improves Mortality Compared to Standard Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Clopidogrel
aspirin
low response
platelet aggregation
Acute Coronary Syndrome
Coronary Stent Implantation
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients following coronary stenting if informed consent was obtained

Brief summary: Comparing standard treatment versus optimized antiplatelet therapy and outcomes measures.

Detailed description: The study is aimed to evaluate if optimized antiplatelet treatment using a test and treat algorithm (with whole blood aggregometry) is able to improve clinical outcome of patients compared to standard treatment without platelet function testing.

Eligibility criteria: Inclusion Criteria:

* coronary stent implantation

Exclusion Criteria:

* no consent

Primary outcomes:
measure: Adverse cardiac events (MACE: mortality,rehospitalisation,myocardial infarction)
timeFrame: Follow up for up to 12 months (retrospective analysis)
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Cardiovascular Center, Ruhr-University Bochum
state: NRW
Study officials:
affiliation: Ruhr-University Bochum, Cardiovascular Center
name: Horst Neubauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neubauer H, Kaiser AF, Endres HG, Kruger JC, Engelhardt A, Lask S, Pepinghege F, Kusber A, Mugge A. Tailored antiplatelet therapy can overcome clopidogrel and aspirin resistance--the BOchum CLopidogrel and Aspirin Plan (BOCLA-Plan) to improve antiplatelet therapy. BMC Med. 2011 Jan 12;9:3. doi: 10.1186/1741-7015-9-3.
citation: Neubauer H, Lask S, Engelhardt A, Mugge A. How to optimise clopidogrel therapy? Reducing the low-response incidence by aggregometry-guided therapy modification. Thromb Haemost. 2008 Feb;99(2):357-62. doi: 10.1160/TH07-10-0624.
citation: Siller-Matula JM, Francesconi M, Dechant C, Jilma B, Maurer G, Delle-Karth G, Gouya G, Ruzicka K, Podczeck-Schweighofer A, Christ G. Personalized antiplatelet treatment after percutaneous coronary intervention: the MADONNA study. Int J Cardiol. 2013 Sep 1;167(5):2018-23. doi: 10.1016/j.ijcard.2012.05.040. Epub 2012 May 30.
Clinical trial NCT02297191: Ultrasound Guided Local Anesthetic Block: Thoracolumbar Interfascial Plane
Official title: Ultrasound Guided Local Anesthetic Field Block Within the Thoracolumbar Interfascial Plane: Distribution of Pain and Temperature Sensation Loss in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: volunteer
pilot study
adults
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the effectiveness of a new approach to numbing (anesthetizing) nerves in the back and to measure how far the area of anesthesia extends on the skin of the back.

Detailed description: This research aims to define a novel field-infiltration nerve block. We will use ultrasound guidance to inject local anesthesia into the potential space between the muscle bodies of the erector spinae. The medial branch of the dorsal ramus of each thoracolumbar nerve innervates the muscle and skin overlying the erector spinae muscle to the midline. By anesthetizing each nerve we believe minimally invasive (1-2 level) back surgery may be completed with less pain and preclude the side-effect laden opioid analgesics.

Eligibility criteria: Inclusion Criteria:

* Healthy Adult

Exclusion Criteria:

* Pregnant women (a urine pregnancy test will be done on all females of childbearing age)
* Liver dysfunction
* Elderly
* Impaired cardiovascular function
* Individuals on amiodarone or history of back surgery
* History of medical allergy to local amide type local anesthetics
* Medical allergy to chlorhexidine
* History of paresthesias
* Inability to lay flat
* Home oxygen requirement
* History of seizures
* Only adults will be eligible.

Primary outcomes:
measure: Anesthesia (monitoring of pain, temperature, and adverse reaction to anesthesia [tinnitus, disorientation, or perioral numbness])
timeFrame: The day of procedure (up to 15 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: William Hand, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Scott T Reeves, MD
role: STUDY_CHAIR
References:
citation: Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.
Clinical trial NCT02080091: Observational Study to Assess the Effect of Iluvien® in DME Patients Insufficiently Responsive to Available Therapies
Official title: ILUMINATE: An Open-Label, Non-Interventional Study of the Safety and Effect of Iluvien® (Fluocinolone Acetonide 190 Micrograms Intravitreal Implant in Applicator) in Patients With Chronic Diabetic Macular Edema (DME) Insufficiently Responsive to Available Therapies
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetic Macular Edema (DME)
Lead sponsor: Alimera Sciences
Sponsor class: INDUSTRY
First posted: 2014-03-06
Enrollment: 25
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: Patients with DME considered insufficiently responsive to available therapies in approximately 25 ophthalmology centers (private practice or hospital) across Germany

Brief summary: This observational study aims to assess the safety and effect of Iluvien® in DME patients considered insufficiently responsive to available therapies in a real life setting in Germany.


Eligibility criteria: Inclusion Criteria:

* Adult patients of both sexes that have signed informed consent after detailed information about the characteristics of the observation by the physician
* DME based on physician's clinical evaluation and demonstrated on fundus photographs and/or optical coherence tomography (OCT);
* Vision impairment associated with DME
* Prior treatment with available therapies for DME; and
* Patients considered by the physician insufficiently responsive to available therapies

Exclusion Criteria:

* Patients with contraindications according to the current Summary of Product Characteristics (SPC)
* The presence of pre-existing glaucoma
* Active or suspected ocular or periocular infection
* The patient is hypersensitive to the active agent or to one of the excipients
* Elevated IOP
* Pregnancy or breastfeeding

Primary outcomes:
measure: Visual Acuity
timeFrame: 24 Months
measure: Number of Patients With Ocular Adverse Events
timeFrame: 24 Months
Secondary outcomes:
measure: Retinal Center Subfield Thickness
timeFrame: 24 months
Other outcomes:
Locations:
city: Neubrandenburg
country: Germany
Study officials:
affiliation: Dietrich-Bonhoeffer-Klinikum
name: Professor Helmut Hoeh, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06410391: Fetal Brain Ultrasound
Official title: Fetal Brain Sonographic Measurements and Normograms in Healthy Fetuses During Second and Third Trimesters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Anomaly
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 110
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All healthy pregnant women came to fetal medicine unit at 15 to 36 weeks

Brief summary: The aim of our study is to determine the range of frontal horn sizes (both upside and downside) in healthy fetuses over gestation and to determine how far FHs are from the midline . Also to determine the range of cavum septi pellucidi and Corpus callosum sizes . Also, to determine whether the maternal body mass index (BMI) affects rates of visualized and non-visualized CSP and CC.

Detailed description: Fetal central nervous system (CNS) abnormalities are among the most commonly encountered congenital abnormalities . Many different methods can be used to obtain prenatal diagnoses, including ultrasound (US), which is one of the most commonly used methods .Neonatal survival rates have increased over the last decades leading to increased number of infants with adverse neurodevelopmental outcomes, including cognitive, motor impairments and behavioral and learning difficulties later in life . Recent studies demonstrated that signs of abnormal neurological development are already present at birth .

Frontal horns (FHs) are the most anterior portions of the lateral ventricles, on each side the cavum septi pellucidi (CSP). In accordance with practice parameters released as early as 1985 by the American Institute of Ultrasound in Medicine, American College of Obstetrics and Gynecology, and Society of Radiologists in Ultrasound, the CSP is examined in screening fetal ultrasound (US) examinations in the biparietal diameter view . Frontal horns (FH) are also visualized in the same plane. Abnormal morphologic characteristics of the FHs such as enlargement, squaring, spearing, and splaying may have an association with congenital intracranial anomalies such as holoprosencephaly, schizencephaly and agenesis of the corpus callosum .

The corpus callosum (CC) is the largest interhemispheric white matter commissure of the human brain . It is a sensitive indicator of normal brain development and maturation

Eligibility criteria: Inclusion Criteria:

* pregnant woman 15 weeks to 36 weeks

Exclusion Criteria:

* congenital malformations
* Multiple pregnancy
* intrauterine infection
* fetuses with Fetal growth restriction

Primary outcomes:
measure: Determine the range of lateral ventricles diameter in healthy fetuses at different gestational ages.,
timeFrame: 5 months
Secondary outcomes:
measure: measurement of Cavum septum and Corpus callosum
timeFrame: 5 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital
Study officials:
References:
Clinical trial NCT03862391: Does Low Flow Anesthesia Reduce Postanaesthetic Emergence Agitation?
Official title: Evaluation of the Effects of Low Flow Anesthesia on Pain and Agitation in Patients After Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Agitated; State, Acute Reaction to Stress
Keywords: postanesthesia agitation
general anesthesia
low-flow anesthesia
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: In this study, the investigators aimed to compare postanesthetic agitation in patients undergoing laparotomic gynecological surgery under general anesthesia using sevoflurane at a fresh gas flow rate of 2 L / min with fresh gas flow rate of 0.5 L / min.

Detailed description: Emergence agitation is a temporary state of mental anxiety that occurs during general anesthesia recovery. It is characterized by emergence agitation, hallucination, excitation, delusion and confusion. Increased hemorrhage due to hypertension may cause serious complications such as injury to the surgical site, patients' self-removal of surgical drains and catheters, and self-extubation. Due to these, emergence agitation results need for additional treatment, psychological stress and increased medical workload for patients and their families.

Emergence agitation after general anesthesia in adult patients was reported up to 20%. However, the ratios are very wide.

In our operating room, the investigators observed that patients with low flow anesthesia were less agitated in the recovery phase than patients with normal flow anesthesia. In our researches, the investigators have not found any studies on the agitation values of patients who underwent low flow anesthesia in the literature.

Eligibility criteria: Inclusion Criteria:

* ASA physical status 1 and 2, underwent gynicological laparotomic surgery under general anesthesia, followed up in PACU(postoperative care unit)

Exclusion Criteria:

* ASA 3 or 4, mental retardation, psychiatric disease, history of malignant hyperthermia in patient or her family, neurological disease, morbid obesity, history of asthma and follow-up in the intensive care unit.

Primary outcomes:
measure: Postanesthetic emergence agitation
timeFrame: 30 minutes after general anesthesia recovery
Secondary outcomes:
measure: postanesthetic nausea and vomiting
timeFrame: 30 minutes after general anesthesia recovery
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University Training and Research Hospital
Study officials:
affiliation: Lecturer
name: Ali Fuat Erdem, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05389891: Hemoglobinopathy Nursing Program and Pediatric Nursing Students
Official title: Effect of a Hemoglobinopathy Nursing Program on Pediatric Student Nurses' Awareness and Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemoglobinopathies
Thalassemia
Sickle Cell Disease
Nurse's Role
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: Benha University
First posted: 2022-05-25
Enrollment: 108
Sex: ALL
Minimum age (years): 19
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hemoglobinopathies are the most common life threatening, monogenic disorders in the world. The most common causes of hemoglobinopathies are sickle cell disease and thalassemia. Aim: This study aimed to evaluate the effect of a hemoglobinopathy nursing program on pediatric nursing students' performance.


Eligibility criteria: Inclusion Criteria:

* pediatric nursing students registered for the academic year 2016/2017

Exclusion Criteria:

* Any student had personal or family history of hemoglobinopathies

Primary outcomes:
measure: Pediatric nursing students' awareness
timeFrame: 10 weeks
measure: Pediatric nursing students' Attitude
timeFrame: 10 weeks
measure: Pediatric nursing students' Practice
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University
state: Other
Study officials:
References:
Clinical trial NCT00780091: Optimisation of Monitoring for Clinical Research Studies
Official title: Evaluation of Efficacy and Cost of Two Monitoring Strategies for Public Clinical Research - OPTIMON: Optimisation of Monitoring for Clinical Research Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: optimization
risk scale
non inferiority
cluster randomization
monitoring strategies
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2008-10-27
Enrollment: 1800
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: All type of patients enrolled in the eligible studies

Brief summary: OPTIMON will compare the efficacy and the cost of two monitoring strategies: one based on the classic standards of quality assurance, and the other one being a priori "optimized" on the main scientific and regulatory principles.

Detailed description: There is no validated standard of monitoring strategy for clinical research studies. Optimon will compare two monitoring strategies - a classical strategy based on the practices of the pharmaceutical industry, and an optimized strategy based on patient's risk level - on their ability to produce exact data, focusing on the main quality criteria: regulatory requirements and scientific validity of results. Optimon is a non inferiority randomized trial.

Eligibility criteria: Inclusion Criteria:

* Clinical Research Studies: risk level A, B, or C in the Optimon risk-assessment scale, with or without a sponsor and the advice of an ethical committee, starting in 2008 and ending before the end of 2010, with a foreseen accrual of 20 patients or more, multicentric with at least 4 clinical sites, with a paper or electronic CRF, with the participating agreement of the coordinating investigator and the sponsor.
* Clinical sites: Sites with a foreseen accrual of 5 patients at least, with the participating agreement of the principal investigator.
* Clinical Research Units: with the label of an institution, with at least 2 years of experience in multicentric studies, with SOPs finalized before 2008, willing to participate in Optimon.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Proportion of patients' file without severe error.
timeFrame: at end of follow-up
Secondary outcomes:
measure: Compounds of the main outcome, other errors, delay to get the results, costs
timeFrame: at end of follow-up
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique du CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Geneviève CHENE, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Lienard JL, Quinaux E, Fabre-Guillevin E, Piedbois P, Jouhaud A, Decoster G, Buyse M; European Association for Research in Oncology. Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer. Clin Trials. 2006;3(5):486-92. doi: 10.1177/1740774506070807.