louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02572570: Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth
Official title: Clinical Investigation of a New Bulk Fill Composite Resin in the Restoration of Posterior Teeth
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dental Restoration Failure of Marginal Integrity
Dental Caries
Unrepairable Overhanging of Dental Restorative Materials
Poor Aesthetics of Existing Restoration
Secondary Dental Caries Associated With Failed or Defective Dental Restorations
Fractured Dental Restorative Materials Without Loss of Materials
Fracture of Dental Restorative Materials With Loss of Material
Keywords: Adult dental care
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: 3M ESPE
First posted: 2015-10-09
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Polymerization shrinkage remains one of the primary disadvantages of composite resin restorative materials (tooth-colored fillings). To minimize the effects of polymerization shrinkage in the restorative treatment, the 3M ESPE company has developed a composite resin called Filtek Bulk Fill Posterior Restorative. Its decreased polymerization shrinkage and properties allow the material to be inserted in one single increment, expediting treatment. This clinical trial is designed to evaluate the performance of the new bulk fill composite resin in Class II (two-surface posterior) fillings.


Eligibility criteria: Inclusion Criteria:

* Be 18 years of age and older
* Have a pair of similar cavities or failed dental fillings in vital permanent posterior teeth requiring treatment
* Be capable of giving written informed consent.

Exclusion Criteria:

* Have a self-reported history of any adverse reaction to materials of the types to be evaluated
* Have a medical or dental history that could possibly complicate the provision of the proposed treatment and/or influence the behavior and performance of the treatment in clinical service.

Primary outcomes:
measure: Restoration Percent Success at Day 1
timeFrame: Assessed immediately post restoration placement completion
measure: Restoration Percent Success at Year 1
timeFrame: Year 1
measure: Restoration Percent Success at Year 2
timeFrame: Year 2
measure: Restoration Percent Success at Year 3
timeFrame: Year 3
measure: Restoration Percent Success at Year 5
timeFrame: Year 5
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill School of Dentistry
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Rick Walter, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06750770: Development and Validation of a Clinical Risk Prediction Model for Early Acute Kidney Injury Within 48 Hours After Liver Transplantation
Official title: Development and Validation of a Clinical Risk Prediction Model for Early Acute Kidney Injury After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Liver Transplantation
Model
Keywords: acute kidney injury, liver transplantation, model, validation
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusion criteria for our study comprised consecutive patients undergoing liver transplantation at Tsinghua University Beijing Changgung Hospital from January 1, 2018, to October 15, 2022. Exclusion criteria were as follows: (1) under 18 years of age (2) post-renal transplant (3) liver combined with other organ transplants (4) preoperative requirement for renal replacement therapy (RRT) (5) patients with second or multiple liver transplants (6) preoperative estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2, and (7) patients with severe illness leading to termination of surgery.

Brief summary: Acute kidney injury (AKI) is a common complication after liver transplantation, with an incidence of 12.7-95%. The occurrence of acute kidney injury after transplantation is related to the poor prognosis of patients, which significantly increases the length of hospital stay, hospitalization costs and mortality of patients. Early recognition of acute kidney injury after transplantation is of great significance. Therefore, by collecting preoperative and intraoperative variables, this study intends to establish and verify a clinical risk prediction model for early AKI after liver transplantation, in order to provide clinicians with a visual prediction tool to identify patients with high risk of early AKI after liver transplantation immediately after the operation, so as to start clinical intervention as soon as possible and improve the prognosis of patients.


Eligibility criteria: Inclusion Criteria:

* patients who underwent liver transplantation in Beijing Tsinghua Changgung Hospital.

Exclusion Criteria:

* (1) under 18 years of age (2) post-renal transplant (3) liver combined with other organ transplants (4) preoperative requirement for renal replacement therapy (RRT) (5) patients with second or multiple liver transplants (6) preoperative estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2, and (7) patients with severe illness leading to termination of surgery.

Primary outcomes:
measure: KDIGO criteria (Kidney Disease: Improving Global Outcomes) used to evaluate postoperative AKI in liver transplant patients.
timeFrame: 48 hours post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Province
Study officials:
References:
Clinical trial NCT02459470: Stroke Volume Variation and Pulse Pressure Variation as Predictors of Fluid Responsiveness During Kidney Transplantation
Official title: Utility of Stroke Volume Variation and Pulse Pressure Variation for Predicting Fluid Responsiveness in Chronic Renal Failure Patients Undergoing Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Keywords: Fluid Responsiveness
Pulse Pressure Variation
Stroke Volume Variation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim pf this prospective study is to investigate the ability of stroke volume variation (SVV) and pulse pressure variation (PPV) to predict fluid responsiveness in patients undergoing kidney transplantation.

Detailed description: Optimal intraoperative fluid management guided by central venous pressure (CVP), a traditional intravascular volume status indicator has been established to improve transplanted graft function during renal transplantation. Recently, stroke volume variation (SVV) and pulse pressure variation (PPV), dynamic preload indices derived from the arterial waveform are increasingly advocated as predictors of fluid responsiveness in anesthetized patients and critically ill patients. However, their usefulness in renal failure patients undergoing renal transplantation has not been investigated. Thus, the aims of this study is to investigate accuracy of SVV and PPV for predicting fluid responsiveness in patients undergoing kidney transplantation.

Eligibility criteria: Inclusion Criteria:

- chronic renal failure patients undergoing renal transplantation

Exclusion Criteria:

* patients with cardiac arrhythmia
* patients with reduced left ventricular function (EF \< 40%)
* patients with valvular heart disease
* patients intracardiac shunt
* patients with pulmonary hypertension
* patients with extensive peripheral vascular disease
* patients with preoperative use of vasopressors or inotropics

Primary outcomes:
measure: stroke volume variation from Flo stroke volume variation from FloTrac/Vigileo system
timeFrame: within 5 minutes after fluid expansion
measure: pulse pressure variation from philips Intelivue MP70 monitor
timeFrame: within 5 minutes after fluid expansion
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Seoul Hospital, Samsung Medical Center
Study officials:
affiliation: Department of Anesthesiology and Pain medicie, Samsung Medical Center
name: Gaab Soo Kim, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05995470: Effect of an Internet-based Dialectical Behaviour Therapy-informed Skills Training for Adult Drinkers
Official title: Effect of an Internet-based Dialectical Behaviour Therapy-informed Skills Training for Reducing Alcohol Consumption and Improving Psychological Distress of Adult Drinkers: A Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Keywords: Dialectical behaviour therapy
Skills training
Internet-based intervention
Psychological distress
Alcohol drinking
Adult drinkers
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 1. To determine the feasibility, acceptability, and preliminary effects of an internet-based DBT-ST for reducing alcohol consumption and improving psychological distress/emotional regulation in adult drinkers
2. To explore the participants' experiences and perceptions of the proposed intervention


Eligibility criteria: Inclusion Criteria:

* Hong Kong Chinese aged ≥18
* Score ≥8 on the Alcohol Use Disorders Identification Test
* Indicate psychological distress as measured by the Depression, Anxiety, and Stress Scale-21
* Have an intention to stop drinking
* Have an electronic device and are willing to receive interventions via the internet

Exclusion Criteria:

* Experiencing psychotic disorders/cognitive impairment/communication problems
* Participating in other alcohol abstinence/related psychosocial interventions

Primary outcomes:
measure: Alcohol consumption
timeFrame: Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
measure: Level of psychological distress
timeFrame: Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
Secondary outcomes:
measure: Self-reported alcohol abstinence
timeFrame: Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
measure: Emotion dysregulation
timeFrame: Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
measure: Distress tolerance
timeFrame: Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
measure: Coping response
timeFrame: Baseline, Post-intervention (upon completion of the 13-week DBT-ST), 3-month post-intervention
Other outcomes:
measure: Acceptability
timeFrame: Post-intervention (upon completion of the 13-week DBT-ST)
measure: Feasibility of the intervention
timeFrame: Post-intervention (upon completion of the 13-week DBT-ST)
measure: Semi-structured interview
timeFrame: Post-intervention (upon completion of the 13-week DBT-ST)
Locations:
city: Hong Kong
country: Hong Kong
facility: Hospital Authority
Study officials:
affiliation: Chinese University of Hong Kong
name: Long Kwan Ho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01546870: Coronary Artery Study in Pediatric Heart Transplantation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Transplant Coronary Artery Disease
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: University of Arkansas
First posted: 2012-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric heart transplant recipients

Brief summary: Transplant coronary artery disease (TCAD) is a significant cause of morbidity and mortality in pediatric heart transplantation (PHT). Understanding the pathophysiology and early detection along with attempted medical management are crucial in preventing advancement of the disease and retransplantation or mortality. Coronary angiogram, although routinely used is insensitive to detect early TCAD. Measurement of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microvascular resistance (IMR) using a doppler pressure and flow intracoronary wire may be more sensitive in evaluating the integrity of coronary vasculature and thus detect pre clinical TCAD. To the best of the investigators knowledge, measurement of these parameters has not been previously reported in PHT.


Eligibility criteria: Inclusion Criteria:

* less than 21 years and above 7 years of age

Exclusion Criteria:

* clinically significant coronary artery disease on angiography and inability to undergo IVUS

Primary outcomes:
measure: Clinical coronary artery disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's hospital
state: Arkansas
Study officials:
References:
citation: Fearon WF, Hirohata A, Nakamura M, Luikart H, Lee DP, Vagelos RH, Hunt SA, Valantine HA, Fitzgerald PJ, Yock PG, Yeung AC. Discordant changes in epicardial and microvascular coronary physiology after cardiac transplantation: Physiologic Investigation for Transplant Arteriopathy II (PITA II) study. J Heart Lung Transplant. 2006 Jul;25(7):765-71. doi: 10.1016/j.healun.2006.03.003. Epub 2006 May 24.
Clinical trial NCT03047070: Lidocaine in ERAS for FESS
Official title: Lidocaine Infusion in Functional Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intraoperative Bleeding
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Functional endoscopic sinus surgery (FESS) is a commonly performed procedure. It is known that bleeding during FESS can affect directly to the visibility of safe landmarks and surgical outcomes.

Detailed description: Functional endoscopic sinus surgery (FESS) is a commonly performed procedure in the head and neck field. It is known that bleeding during FESS can affect directly to the visibility of safe landmarks and surgical outcomes.

Use of vasoactive drugs to control bleeding is not without pitfalls. Systemic effects of epinephrine may constitute a potential hazard in patients with hypertension, ischemic heart disease, anemia, preexistent liver or renal damage and endocrine dysfunction (hyperthyroidism, pheochromocytoma and diabetes mellitus).

Lidocaine is a prototypical local anesthetic, but it also has systemic effects that are mediated by inhibitory effects on N-methyl-d-aspartate receptors and leukocyte priming. Consequently, systemic lidocaine is antiinflammatory, analgesic, and antihyperalgesic. Randomized clinical trials, however, have produced mixed results. Several studies have shown reduction in postoperative opioid consumption and pain scores, whereas others have failed to show a benefit.

Eligibility criteria: Inclusion Criteria:

* Patients, 20-50 yr ASA class I and II
* Elective Functional endoscopic sinus surgery (FESS) under general anesthesia.

Exclusion Criteria:

* Patient refusal, allergy to the study medication, pre-existing chronic pain at any site requiring treatment, intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs), psychiatric or neurological disorders, seizure disorder requiring medication within the previous 2 years, body mass index \> 30 kg/ m2, revision sinus surgery, pregnancy, and patients with cardiovascular, cerebrovascular, respiratory, renal or hepatic diseases

Primary outcomes:
measure: Intraoperative bleeding
timeFrame: Intraoperative assessment till end of operation
Secondary outcomes:
measure: Quality of surgical field
timeFrame: intraoperative assessment
measure: Surgeon satisfaction
timeFrame: At the end of surgery
measure: Mean arterial pressure
timeFrame: intraoperative assessment
measure: Heart rate
timeFrame: intraoperative assessment
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine Assuit University
state: Assuit
city: Asyut
country: Egypt
facility: Seham Mohamed Moeen Ibrahim
Study officials:
affiliation: Assiut University
name: Seham M Moeen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03274570: Factors Affecting Hand Dysfunction in Patient With Rheumatoid Arthritis and Its Correlation With Quality of Life
Official title: Factors Affecting Hand Dysfunction in Patient With Rheumatoid Arthritis and Its Correlation With Quality of Life
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient attending the Rheumatology and Rehabilitation outpatient clinic and in-patient department, Faculty of Medicine, Assuit University Hospitals during the period from September 2017 until September 2018

Brief summary: The aims of the research are:

* To predict factors affecting hand dysfunction in patient with rheumatoid arthritis
* To study the effect of hand dysfunction on quality of life in patient with rheumatoid arthritis

Detailed description: Rheumatoid Arthritis (RA) is the most common chronic autoimmune systemic inflammatory arthritis, associated with considerable impairments of Quality of life .

Hand is the principle means by which an individual interacts with people and objects in the external environment .Many factors affect hand function in addition to arthritis ,. Many RA patients suffer from an increased loss of muscle mass with a significant impact on these patients' quality of life , and also Distal sensory, mixed sensorimotor, mononeuritis multiplex and entrapment neuropathy are the most commonly reported types of neuropathy in RA .So assessment of factors causing hand dysfunction can provide us a quick and early insight on the debilitating effects of RA on functioning and disability.Thus Early intervention can then be initiated which will help limit joint damage and thereby improve functional outcomes.

Eligibility criteria: Inclusion Criteria:

* Adult Patients who fulfilled the American College of Rheumatology (ACR) (2010) criteria for RA, attending the Rheumatology and Rehabilitation outpatient clinic and in-patient department, Faculty of Medicine, Assuit University Hospitals.

Exclusion Criteria:

* Patients with other rheumatic diseases.
* Patients less than 18 years old.
* Patients with co-morbidities influencing disease activity and hand function (e.g., end- stage liver or renal disease, serious infections, or severe cardiac, respiratory, gastrointestinal disease) .
* Patient with any recent history of hand trauma, or surgery.
* Patient with neurological involvement as , peripheral neuropathy and radiculopathy

Primary outcomes:
measure: quality of life
timeFrame: one year
Secondary outcomes:
measure: hand function
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Safaa A Mahran, professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Essam Abda, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02131870: Study of the Iron Absorption From Capsules Containing Lactobacilli and Iron
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: iron absorption
healthy females
child bearing age
Lead sponsor: Probi AB
Sponsor class: INDUSTRY
First posted: 2014-05-06
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to study the effect of a probiotic product on iron absorption in healthy females of child-bearing age.


Eligibility criteria: Inclusion Criteria:

* Female
* Age ≥19 and ≤45 years
* Hb \>117g/L

Exclusion Criteria:

* Gastrointestinal diseases
* Metabolic diseases
* Use of other probiotic products during the study and 2 weeks before the study start
* Pregnant or breast-feeding
* A serum ferritin level \>60 µg/L
* Medication (oral contraceptives allowed)
* Intake of dietary supplements (incl. iron) during the study and two weeks before the study start
* No blood donation in the last 2 months
* High C-reactive protein levels

Primary outcomes:
measure: Iron absorption ratio in blood samples
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Internal Medicin and Clinical Nutrition, the Sahlgrenska Academy, Gothenburg University
Study officials:
References:
citation: Hoppe M, Onning G, Hulthen L. Freeze-dried Lactobacillus plantarum 299v increases iron absorption in young females-Double isotope sequential single-blind studies in menstruating women. PLoS One. 2017 Dec 13;12(12):e0189141. doi: 10.1371/journal.pone.0189141. eCollection 2017.