louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06369779: Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment
Official title: Clinical Evaluation of Class I and II Cavities Restored With the Combination of a New Flowable and a New Sculptable Universal Bulk-fill Composite: A Prospective Single Arm Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Insufficient Dental Filling or Primary Caries (Class I or II Cavities in Premolars or Molars)
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
First posted: 2024-04-17
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall objective of this clinical investigation is to evaluate the clinical safety and performance of the new flowable composite TM Flow and the new sculptable composite TM Fill for restoration of class I and class II cavities. The fillings are assessed according to selected FDI (Fédération Dentaire Internationale) criteria at baseline (7-10 days after placement of filling) and after 1, 6, 12, 24, 36 and 60 months.


Eligibility criteria: Inclusion Criteria:

* Informed Consent signed by the subject
* Age: 18-65 years
* Indication Class I or II direct restorations in premolars or molars (Replacement of insufficient fillings due to secondary caries, fractures, insufficient marginal adaptation, loss of filling or primary caries)
* Cavity width must be at least half of the cusp tip distance
* Vital teeth, regular sensitivity
* Sufficient language skills
* No active periodontits
* Preoperative VAS (visual analogue scale) values \< 3 regarding tooth sensitivity and biting

Exclusion Criteria:

* Sufficient isolation of the cavity not possible
* Not completed hygiene phase or poor oral hygiene
* Missing antagonist, non-occlusion
* Missing tooth adjacent to the tooth to be treated
* Restorations replacing more than 1 cusp
* Caries profunda or very deep cavity
* Patients with a proven allergy to ingredients of the used materials (methacrylates) or local anesthetics (Articain, sulfite)
* Patients with severe systemic diseases
* Pregnancy

Primary outcomes:
measure: Postoperative Hypersensitivity
timeFrame: 1 month
Secondary outcomes:
measure: Evaluation of Functional (e.g. Fracture of the Material and Retention), Biological (e.g. Caries at Restoration Margins) and Aesthetic (e.g. Color Match) Properties of the Restorations
timeFrame: 5 years
Other outcomes:
Locations:
city: Schaan
country: Liechtenstein
facility: Ivoclar Vivadent AG
Study officials:
References:
Clinical trial NCT00912379: Hemoglobin Measured by MASIMO SpHb™ Device and Laboratory Measurement
Official title: Comparison of the Hemoglobin Results Obtained With the Masimo SpHb™ Device and the Clinical Laboratory Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients' Assessment
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 300
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: emergency unit patients and ICU patients requiring an hemoglobin determination

Brief summary: The purpose of this study is to compare the hemoglobin results obtained with the Masimo SpHb™ device and the Clinical Laboratory.


Eligibility criteria: Inclusion Criteria:

* emergency unit patients, PACU (post-anaesthesia care unit) and ICU patients requiring an hemoglobin determination

Exclusion Criteria:

* none

Primary outcomes:
measure: Accuracy of the Masimo Labs Pulse-Hemoglobin-Meter Monitor
timeFrame: End of the period of recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
References:
Clinical trial NCT02988479: Out-of Pocket Payments in Patients With Lymphedema
Official title: Out-of Pocket Payments in Patients With Primary Lymphedema in France and Inequities of Access to Healthcare
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Lymphedema
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 108
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients meeting the inclusion criteria will be included in each participating centre during the inclusion phase

Brief summary: Primary lymphedema is a chronic condition posing a high burden on patients. Clinical guidelines emphasize the role of compression therapy by prescription medical devices. Even in a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist due to the price and reimbursement setting processes. OOPP may threaten the equity of care and drive patients to forgo care. The investigators aim was to analyze the distributive effects of OOPP for primary lymphedema patients in France.

A prospective, multicenter study will be conducted in France in 2015 on patients with primary lymphedema. Household ability to pay will be specified by net income and OOPP will be assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices, nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory and voluntary health insurance reimbursements will be considered. The investigators will combine concentration curves and concentration indices to assess the distributive effects.


Eligibility criteria: Inclusion criteria:

* Patient aged over six years, with primary lymphedema, regardless of the severity of the disease;
* Patient treated in one of the centres participating in the study;
* Patient (and her legal representative for minors) who gave her written consent \[or did not refuse to participate, according to local Law\];
* Patient with Internet access and an active email address.

Exclusion criteria:

* Patients with concomitant chronic venous insufficiency;
* Patient not covered by any health care insurance scheme;
* People protected under the law.

Primary outcomes:
measure: The mean monthly out-of-pocket payment as assessed by an online self-questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Gregoire MERCIER, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mercier G, Pastor J, Clement V, Rodts U, Moffat C, Quere I. Out-of-pocket payments, vertical equity and unmet medical needs in France: A national multicenter prospective study on lymphedema. PLoS One. 2019 May 8;14(5):e0216386. doi: 10.1371/journal.pone.0216386. eCollection 2019.
Clinical trial NCT05825079: Does Weightbearing Crutch Technology Impact Patient Compliance?
Official title: A Randomized, Parallel, Two Arm, Unblinded Single-center Study of the Effects of Patient-provided Feedback on Fracture Healing and Weight-bearing Status in Orthopedic Patients Undergoing Operative Fixation or Non-operative Treatment of Isolated Tibial Plateau, Pilon, and Other Ankle Fractures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fracture Healing
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: ComeBack Mobility
First posted: 2023-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to determine if weight-bearing crutch technology that delivers active feedback to patients during their treatment will impact patient compliance with physician instructions.


Eligibility criteria: Inclusion Criteria:

* Willing and able to participate in study and complete consent
* Will undergo treatment of an isolated tibial plateau, pilon, or ankle fracture and placed in a non-weightbearing status with the use of crutches at NYU.
* Have access and use of a mobile phone (exclusively iOS and/or Android devices)

Exclusion Criteria:

* Patients with concomitant TBI
* Polytrauma patients
* Pathologic fractures
* Prisoners

Primary outcomes:
measure: Percent (%) Change in Average Weight On Crutch from Week 2 to Week 12
timeFrame: Week 2, Week 12
Secondary outcomes:
measure: Time to Recovery
timeFrame: Up to Week 12
measure: Change in Visual Analogue Scale (VAS) - Pain Score from Baseline to Week 12
timeFrame: Baseline, Week 12
measure: Percent (%) of Participants with Injury Complications
timeFrame: Up to Week 12
measure: Percent (%) of Participants who Experience Nonunion/Malunion of Lower Extremity Injury
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Kenneth A. Egol, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02996279: Chorioamnionitis and Proinflammatory S100A12
Official title: Impact of Chorioamnionitis on Maternal and Fetal Levels of Proinflammatory S100A12
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chorioamnionitis Affecting Fetus or Newborn
Keywords: Neonate
Chorioamnionitis
S100A12
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 69
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Very Premature Mother-Neonate Pairs

Brief summary: Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS) and increased levels of proinflammatory molecules.

Detailed description: Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS). The aim of this pilot study was to evaluate S100A12, a marker of innate immune activation, in mothers with or without HCA and in their infants.

Concentrations of S100A12, Interleukin 6 (IL-6) and C-reactive protein (CRP) were evaluated in maternal, cord, and neonatal blood of very preterm infants. Histologic examinations of placentae and umbilical cords were performed.

Eligibility criteria: Inclusion Criteria:

Preterm Birth

Exclusion Criteria:

Congenital Abnormalities

Primary outcomes:
measure: S100A12 in Presence of Maternal Chorioamnionitis
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04427579: Anxiety and Depression in COPD; Prevalence, Detection and Prognosis
Official title: Anxiety and Depression in COPD; Prevalence, Detection and Prognosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COPD
Anxiety Disorders
Depressive Disorder
Keywords: Metacognitions
Hospital Anxiety and Depression Scale
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: LHL Hospital Gardermoen
name: Priory Hospital Altrincham
First posted: 2020-06-11
Enrollment: 200
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: All adults referred to and initiating a 2-4 weeks in-hospital rehabilitation course.

Brief summary: The current cohort study of 300 stable COPD patients aims to assess the following topics:

* The prevalence of anxiety and depressive disorders in patients with COPD
* The screening properties of Hospital Anxiety and Depression Scale in patients with COPD
* The prognostic influence by anxiety or depressive symptoms and anxiety or depressive disorder.
* whether characterization of 1) affective aspects of dyspnea symptoms or 2) persistent styles of thinking (worry or rumination) and metacognitions that drive these may improve the current recommendation of screening for anxiety and depression in COPD in relation to its clinical relevance on functional status and three year outcome


Eligibility criteria: Inclusion Criteria:

* Participant in in-hospital pulmonary rehabilitation at LHL-hospital Gardermoen
* Diagnosis of COPD

Exclusion Criteria:

* Acute exacerbated phase of COPD

Primary outcomes:
measure: COPD exacerbation rate
timeFrame: 3 years
measure: Mortality rate
timeFrame: 3 years
Secondary outcomes:
measure: Assessment of Health-related Quality of Life With RAND-36
timeFrame: 3 years
Other outcomes:
measure: The prevalence of anxiety disorder
timeFrame: 1 year
measure: The prevalence of depressive disorder
timeFrame: 1 year
Locations:
city: Jessheim
country: Norway
facility: LHL-hospital Gardermoen
Study officials:
affiliation: University Hospital, Akershus
name: Gunnar Einvik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06749379: LIPEDEMA AWARENESS IN FIBROMYALGIA
Official title: LIPEDEMA AWARENESS IN FIBROMYALGIA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Lipedema
Keywords: fibromyalgia, lipedema, awareness
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study included 100 female patients over the age of 18 who met the fibromyalgia diagnostic criteria according to the American College of Rheumatology (ACR) 2016 Fibromyalgia Diagnostic Criteria.

Brief summary: Lipedema is a chronic debilitating condition that impacts the subcutaneous adipose tissue of the extremities. It is a chronic condition but should not be regarded as always progressing.The clinical course varies individually and is unpredictable. It may considerably diminish the patient's quality of life. Fibromyalgia, similar to lipedema, is a debilitating chronic pain disease of unclear origin that primarily affects women. It is a complex syndrome marked by widespread pain and tenderness. Fibromyalgia and lipedema are both marked by pain related to soft tissue. Both disorders are not amenable to curative treatment, resulting in a significant burden on individual and public health. No definitive indicators, including abnormal laboratory or imaging results, can be discerned to differentiate one disorder from another.

With this perspective, the aim of our study was to evaluate the presence of lipedema and lipedema-related factors in fibromyalgia patients.


Eligibility criteria: Inclusion Criteria:

* female patients
* over the age of 18
* who met the fibromyalgia diagnostic criteria according to the American College of Rheumatology (ACR) 2016 Fibromyalgia Diagnostic Criteria

Exclusion Criteria:

* renal or cardiac insufficiency,
* the use of any drug that could influence body fluid and electrolyte balance,
* the presence of a major somatic disease.

Primary outcomes:
measure: visual analog scale
timeFrame: 1 month
measure: Presence and stages of lipedema were diagnosed according to S1 guidelines of the German Society of Phlebology
timeFrame: 1 month
measure: The American College of Rheumatology (ACR) 2016 Fibromyalgia Diagnostic Criteria
timeFrame: 1 month
measure: The Revised Fibromyalgia Impact Questionnaire
timeFrame: 1 month
measure: Beck Depression Inventory
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University
Study officials:
References:
Clinical trial NCT03374579: co2 Gap and co2/o2 Ratio in Liver Transplant Patients
Official title: Use of the Venoarterial Carbon Dioxide Gap and Arteriovenous Oxygen Content to Guide the Resuscitation in the Liver Transplant Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Transplantation
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Fluid challenge with assessment of change of co2 gap
Primary purpose: DIAGNOSTIC

Brief summary: finding surrogate to co to trace the effect of preload challenge would make the test more applicable without the need of advanced hemodynamic monitors,suggested that co2 gap can be used to detect FR after mini fluid challenge and fluid bolts .

Detailed description: use of carbon dioxide gap and arterio venous oxygen content to trace the effect of preload challenge by giving via a specific venous line , first 150 ml is infused over one minute, after stroke volume at one minute measure the remaining 350 ml is infused over 14 minutes at constant rate , the fluid challenge performed with albumin 5% , fluid responsiveness is an increase in stroke volume by 15% after infusion of 500ml albumin 5%.

Objectives is to investigate the ability of VA-co2 gap and gap/ ratio to predict the hemodynamic response to mini fluid challenge, and to compare the validity of VA-co2 gap and gap/ratio with svo2 for prediction of fluid responsiveness.

Eligibility criteria: Inclusion Criteria:

* patients post liver transplantation
* serum lactate \>2mmol/L

Exclusion Criteria:

* age less than 18 years
* patients with fulminant liver failure.

Primary outcomes:
measure: co2gap
timeFrame: 30 minuets after fluid bolus
Secondary outcomes:
measure: Stroke volume
timeFrame: Baseline 30 minutes after Icu admission, 1 minutes after mini fluid challenge , 30 minutes after fluid bolus
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Medical School
city: Cairo
country: Egypt
facility: Kasralainy hospital
Study officials:
affiliation: kasrelainy medical school,cairo university,cairo,egypt
name: Ahmed m Mukhtar, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: kasrelainy medical school,cairo university,cairo,egypt
name: Hassan kh Nagi, professor
role: STUDY_CHAIR
References:
Clinical trial NCT02773784: Comparison of CNB and Surgical Specimens for ER, PgR, HER2 Status and Ki67 Index in Invasive Breast Cancer.
Official title: Comparison of Core Needle Biopsy (CNB) and Surgical Specimens for Estrogen Receptor (ER), Progesterone Receptor (PgR), Human Epidermal Growth Factor Receptor 2 (HER2) Status and Ki67 Index in Invasive Breast Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Breast Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 314
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: invasive breast cancer diagnosed by core needle biopsy

Brief summary: * This is a prospective, single-center, non-randomized, non-controlled study.
* The estrogen receptor (ER), progesterone receptor (PgR), HER2 status and Ki67 index of CNB specimen are critical biomarkers for making neoadjuvant therapy strategy in invasive breast cancer. The concordance of these biomarkers between CNB and surgical specimen was varied in previous retrospective reports. The aim of this study is to determine the discordance of these biomarkers between CNB and surgical specimen and the influence of making treatment strategy by the discordance.


Eligibility criteria: Inclusion Criteria:

* • histologically confirmed primary invasive breast cancer by core needle biopsy

Exclusion Criteria:

* • pathological diagnosed ductal carcinoma in situ or microinvasive breast cancer by core needle biopsy

  * patient plans to receive neo-adjuvant system therapy

Primary outcomes:
measure: The accuracy of ER, PgR, Her-2 and Ki67 for core needle biopsy (CNB) using the surgical specimens as reference, respectively.
timeFrame: within 4 weeks after obtaining the post-surgery pathological results
Secondary outcomes:
measure: Discordance of system therapy strategies between using biomarkers of CNB and surgical specimens.
timeFrame: within 4 weeks after obtaining the post-surgery pathological results
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Zhao-Qing Fan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02387684: Efficay of Extended Peginterferon Alpha 2a Treatment in HBeAg Negative Chronic Hepatitis B Patients
Official title: Efficay of Extended Peginterferon Alpha 2a(PEG-IFN a-2a) Treatment in HBeAg Negative Chronic Hepatitis B Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
Keywords: chronic hepatitis B
interferon
peginterferon
HBsAg loss
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2015-03-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population in this cohort study was composed of HBeAg negative chronic hepatitis B patients defined as HBsAg positive, HBeAg negative,and detectable HBV DNA load with ALT level ≥41 U/L for more than 6 months.

Brief summary: The most important method to slow down and stop the liver disease progression in patients with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response during treatment or obtain sustained viral response after treatment. The aim of the therapy with interferon is make patients obtain immune control to HBV defined as sustained viral response after treatment, however, most patients can't get this target after 48 weeks of interferon treatment, and some patients need extended treatment in clinical practice to enhance the rate of sustained viral response or HBsAg loss occurred during treatment. In this cohort study, the efficacy of extended therapy of interferon in HBeAg negative chronic hepatitis B patients will be evaluated.

Detailed description: In this cohort study, the HBeAg negative chronic hepatitis B patients would be treated with peginterferon alpha 2a(PEG-IFN a-2a) for 96 week and followed 24 weeks after treatment. Serum HBV DNA load, HBsAg/anti-HBs level, HBeAg/anti-HBe will be tested at enrollment and every 3 months during treatment and follow period. Parameters of liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. The efficacies were evaluated by the rate of HBsAg loss during treatment and the rate of sustained viral response after treatment and follow up.

Eligibility criteria: Inclusion Criteria:

* HBeAg negative chronic hepatitis B patients

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver

Primary outcomes:
measure: rate of sustained viral response
timeFrame: 120 weeks
Secondary outcomes:
measure: rate of HBsAg loss
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan hospital,Capital Medical University
state: Beijing
Study officials:
References: