louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02589743: Randomized Clinical Trial of Occlusal Sealant
Official title: Impact of the Intermediary Layer on Sealant Retention: A Randomized 24-month Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Caries
Keywords: clinical trial
pit and fissure sealants
tooth eruption
retention
adhesive system
intermediary layer
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2015-10-28
Enrollment: 65
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study assessed long-term impact of tooth Eruption Stages (ES) on sealant retention on occlusal surfaces previously coated with intermediary bonding layer and it determined caries incidence outcome evolved. The treatment were (sealant/technique): Fluroshield; Helioseal Clear Chroma; Single Bond and Fluroshield; Excite and Helioseal Clear Chroma.

Detailed description: The greatest risk of sealant failure occurs soon after tooth eruption, when contamination with saliva and gingival fluid is almost inevitable. The use of an intermediate bonding layer between humidity contaminated enamel and sealant can improve bond strength, reduces microleakage, and enhances resin flow into fissures. The benefit of primer and adhesive layer beneath the sealant seems to be based on a combination of moisture-chasing effects of the hydrophilic primer, increased flow dispersion imparted by the less viscous primer and adhesive and increased flexibility of the combined and polymerized primer/adhesive/resin complex once reaction is complete.

Eligibility criteria: Inclusion Criteria:

* Four caries-free erupted first molar permanent teeth; no systemic diseases and no dental material allergies.

Exclusion Criteria:

* Carious or absence first molar permanent teeth.

Primary outcomes:
measure: Sealant retention and prevention of dental caries assessed by defined clinical scoring system
timeFrame: 6-mouth
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Piracicaba Dental Scholl - University of Campinas
name: Kamila Kantovitz, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Piracicaba Dental Scholl - University of Campinas
name: Kelly Moreira, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05252143: Evaluation of Elastic Properties of Ascending Aorta
Official title: Elastic Properties of the Ascending Aorta Evaluated by Imaging and Biaxial Testing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Compliance, Magnetic Resonance Imaging, Biaxial Testing, Elastic Modulus
Lead sponsor: Centre Hospitalier La Chartreuse
Sponsor class: OTHER
First posted: 2022-02-23
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: 200 patients operated in cardiac surgery unit of Dijon hospital starting in December 2018

Brief summary: The aim of our study is to assess a correlation between local patient specific elastic modulus distribution of the ascending aorta from a biaxial tensile test and MRI measurements of the elastic properties of the aorta.

A total of 70 patients referred for ascending aorta (AA) replacement underwent a preoperative cardiac-MRI for the evaluation the elastic properties and ascending aorta tissue was collected for biaxial testing to obtain maximum elastic modulus

Detailed description: Observational and prospective trial on medical data only. The patients are operated of planned aortic aneurysm without additional intervention.

The preoperative cardiac MRI are planned in standard of care.

Eligibility criteria: Inclusion Criteria:

* patient referred for ascending aorta aneurysm requiering replacement
* elective patient

Exclusion Criteria:

* claustrophobia
* contraindication to performing cardiac MRI

Primary outcomes:
measure: aortic compliance of ascending aorta (mm2/mmHg)
timeFrame: preoperative cardiac MRI performing between 1 month and 1 day before surgery
Secondary outcomes:
measure: maximum elastic modulus (MPa) of ascending aorta
timeFrame: biaxial testing performing between 1 and 6 hours after procedure
Other outcomes:
Locations:
city: Dijon
country: France
facility: Dijon University Hospital
Study officials:
References:
Clinical trial NCT05272943: Oxygen Saturation Measurement With Pulse Oximetry and With Smart Phones and Smart Wearable
Official title: Oxygen Saturation Measurement With Pulse Oximetry and Smart Phones and Smart Wearable: Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Oxygen Saturation Measurement
Keywords: pulse oximetry
pediatric patient
smart phone
smart wearable
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Masaryk University
First posted: 2022-03-10
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 19
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients during during preanesthesia visit, general anesthesia, PACU and PICU stay will be eligible for inclusion

Brief summary: Oxgen saturation measurement with the pulse oximetry is considered as a standard of care for respiratory system monitoring. The evaluation of measured oxygen saturation could lead to the clinical decision making in taking care of patient with respiratory failure. Smart electronics (such smart phones, smart watch, and others) are currently equipped with the sensors and applications that allows the peripheral oxygen saturation, however the corelation between the validated measurement (pulse oximetry) and smart electronics measurement is not known at the moment. In case of close correlation and high sensitivity, could be the smart electronics used for oxygenation evaluation of outpatients together with possible early deterioration detection.

Detailed description: After informed consent from patients and/or legal guardian the oxygen saturation will be measured by calibrated pulse oxymetry (validated for medical use only) and by smart electronics (smart phones and smart wearable) in pediatric patients during the preanesthesia evaluation, under general anesthesia, during the postanesthesia care unit (PACU) stay, and at pediatric intensive care unit (PICU) stay. In one patient, overall 6 measurements in will be performed (3 on right and 3 on left hand).

Eligibility criteria: Inclusion Criteria:

* Informed consent
* pediatric patients during preanesthesia visit
* pediatric patients during general anesthesia
* pediatric patients during PACU stay
* pediatric patients during PICU stay

Exclusion Criteria:

* outside age limits
* refused to participate

Primary outcomes:
measure: Pulse oximetry correlation
timeFrame: Perioperatively
Secondary outcomes:
measure: Measurement tolerance
timeFrame: Perioperatively
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
state: South Moravian Region
Study officials:
affiliation: Department of paediatric anaesthesia and intensive care medicine
name: Petr Stourac, prof. MD., Ph.D., MBA
role: STUDY_CHAIR
References:
Clinical trial NCT03598543: Epidemiology of Klebsiella Pneumoniae in China
Official title: Klebsiella Pneumoniae Infection in China: Epidemiology, Molecular Characteristics, Treatment, and Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Klebsiella Pneumoniae Infection
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patients with the age between 18 and 85 years old and with either community or hospital Klebsiella pneumoniae infection.

Brief summary: Klebsiella pneumoniae is one of the most common pathogens causing both community-onset and nosocomial infection. More worse, the emergency of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) had cause the clinical therapy be very difficult. However, there is not much empirical data as to the prevalence, risk factors, characteristics,outcomes and the rationality of the current therapy for the Klebsiella pneumoniae infection in China.Thus, the study was aimed to investigate the epidemiology and risk factors, characteristics, outcomes and the rationality of the current therapy for the Klebsiella pneumoniae infection in China.

Detailed description: All the patients with culture positive of Klebsiella pneumoniae were screened and reported to the the clinical doctors and confirmed by them. And the clinical characteristics of the patiens, such as baseline data, outcomes etc, were recorded. Finially, to find the prevalence, risk factors, characteristics, outcome and the rationality of the current therapy for the Klebsiella pneumoniae infection in China.

Eligibility criteria: Inclusion Criteria:

- new confirmed community-onset or noscomial infection of Klebsiella pneumoniae infection

Exclusion Criteria:

* Age\<18, or \>85 years old; Mixed infection of Klebsiella pneumoniae and other microbes

Primary outcomes:
measure: CRKP infection
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Yun-song Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01236443: Study of Photodynamic Therapy (PDT) Using HPPH in Barrett's Esophagus
Official title: A Phase I/II Study of Photodynamic Therapy (PDT) Using 2-[1-hexyloxyethyl]-2-devinylpyropheophorbide-a (HPPH) for the Treatment of High Grade Dysplasia, Carcinoma-in-situ and Early Adenocarcinoma in Barrett's Esophagus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Barrett's Esophagus
CIS
High Grade Dysplasia
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2010-11-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Study to identify toxicity and optimal photodynamic treatment parameters using the photosensitizer 2-\[1-hydroxyethyl\]-2-devinylpyropheophorbide-a (HPPH) in high grade dysplasia, carcinoma-in-situ, or early adenocarcinoma in Barrett's esophagus.


Eligibility criteria: Inclusion Criteria:

* Patient must have biopsy proven high-grade (severe) dysplasia, carcinoma-in-situ or early stage adenocarcinoma;
* Patient may have received prior therapy; e.g. Nd-YAG laser, radiation therapy or chemotherapy. At least one month must have elapsed between prior treatments and PDT.
* Tumors can be primary or recurrent, Stage 0 or I, N0M (any).
* Patients must have no contraindications to endoscopy.
* Male or female patients must be 18 years old or older. Female patients must not be pregnant and must be practicing a medically acceptable form of birth control or be sterile or post-menopausal. A pregnancy test is required and must be negative.
* Patients must sign an Informed Consent according to FDA guidelines and be acceptable to the RPCI IRB.
* Patients must have a Karnofsky status 50 or above.
* Operable patients are not excluded.

Exclusion Criteria:

* Patients with tumors of grade greater than T-1.
* Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds.
* WBC \<2,000; platelet count \<50,000, prothrombin time 1.5 times above the upper normal limit.
* Patients with impaired renal and/or hepatic function (total serum bilirubin \>3.0 mg/d, serum creatinine \>3 mg%, alkaline phosphatase (hepatic) or SGOT \>3 times the upper normal limit.
* Patients on concurrent chemotherapy or radiation therapy will be excluded as well as those having received prior treatment for the esophageal cancer within 4 weeks of enrollment.
* If the patient has cancer other than non-melanoma skin cancer they must be deemed disease free by their treating physician.

Primary outcomes:
measure: Toxicity of HPPH at different doses
timeFrame: 2 days
Secondary outcomes:
measure: Determine optimal PDT parameters using HPPH in HGD, CIS and Barrett's esophagus
timeFrame: length of study
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park cancer institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Hector Nava, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02706743: Assessment of Quality of Life After Adjunct Radioiodine Therapy in Patients With Differentiated Thyroid Cancer
Official title: Effect of Radioiodine Remnant Ablation on Quality of Life in Patients With Differentiated Thyroid Cancer:a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Neoplasms
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with differentiated thyroid cancer initially referred to adjuvant radioiodine treatment in nuclear medicine department, Zhujiang Hospital, Southern Medical University.

Brief summary: The aim of this study was to assess the impact of adjuvant radioactive iodine therapy on the quality of life(QOL) in differentiated thyroid cancer patients and to identify independent factors affecting changes in the QOL.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed new diagnosis of differentiated thyroid cancer, recently treated by total thyroidectomy
* Must sign a consent form before treatment
* One year or more of follow-up after radioiodine ablation

Exclusion Criteria:

* Patients with follicular, Hürthle cell, poorly differentiated, medullary, or anaplastic thyroid carcinoma
* Pregnant or lactating women
* Patients that received adjuvant radioiodine treatment in the past
* Patients with other cancer

Primary outcomes:
measure: Change in patients with differentiated thyroid cancer from baseline Medical Outcome Study Short-Form 36(MOS SF-36) questionnaire at 12 months
timeFrame: baseline and 12 months
measure: Change in patients with differentiated thyroid cancer from baseline Hospital Anxiety and Depression Scale at 12 months
timeFrame: baseline and 12 months
measure: Change in patients with differentiated thyroid cancer from baseline Brief Fatigue Inventory at 12 months
timeFrame: baseline and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital,Southern Medical University
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: Sun Y Gang, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00509743: Study to Assess Effects of Age, Weight, and Body Composition on the Pharmacokinetics of IV Diclofenac Sodium
Official title: An Open-Label, Single-Dose Study to Assess the Effects of Age, Weight, and Body Composition on the Pharmacokinetic Profile, Safety, and Tolerability of Intravenous Diclofenac Sodium (DIC075V) in Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Adult volunteers
Lead sponsor: Javelin Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-07-31
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers.

Detailed description: This study is an open label, single center, single-dose study to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers. This study will be conducted in two cohorts. The first cohort of subjects will be selected based on body mass index (BMI) and weight criteria. The second cohort of subjects will be selected based on age.

Eligibility criteria: Inclusion Criteria:

* Adult volunteers over age 18

Exclusion Criteria:

* Known allergy or hypersensitivity to diclofenac, aspirin, or other NSAIDs or to any of the excipients of the study preparation
* History of previous and/or present cerebral hemorrhage, peptic ulceration, GI bleeding or any bleeding diathesis, positive for hepatitis B or hepatitis C or HIV antibodies

Primary outcomes:
measure: To assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (DIC075V) in adult volunteers.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miramar
country: United States
facility: Comprehensive Phase One
state: Florida
city: Baltimore
country: United States
facility: PAREXEL International
state: Maryland
Study officials:
affiliation: Parexel
name: D. Ronald Goldwater, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Comprehensive Phase One
name: William Gerson, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04918043: Alcohol Use During Pregnancy in Finland According to Meconium Samples
Official title: Raskaudenaikaiset Elintavat ja Etyyliglukuronidin Esiintyminen Mekoniumissa Suomessa
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Alcohol Spectrum Disorders
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Lastentautien tutkimussäätiö
First posted: 2021-06-08
Enrollment: 1000
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of the newborn babies that are born at the Helsinki University Central hospital maternity ward.

Brief summary: Meconium samples are collected anonymously from newborns in Helsinki University Hospital maternity ward. The study tries to to find how many women continue to use alcohol during the second half of the pregnancy. Meconium samples are tested for ethylglucuronide (EtG), a metabolite of ethanol, that accumulates in the meconium. Altogether 1000 samples are taken. The sample results are compared to anonymously answered questionnaire about alcohol use.


Eligibility criteria: Inclusion Criteria:

* newborn baby

Exclusion Criteria:

-

Primary outcomes:
measure: EtG
timeFrame: Once
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: HUCS
name: Hanna Kahila, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01285843: Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component
Official title: Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Arthritis
Avascular Necrosis
Fracture of the Femoral Neck or Head
Congenital Hip Dysplasia
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2011-01-28
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This is a monocentric, prospective, randomized clinical survey to verify if the periprosthetic remodelling brought about either the AMIStem or the Quadra femoral component is equivalent.


Eligibility criteria: Inclusion Criteria:

* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
* Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use (enclosure 2)).
* Patients must be willing to comply with the pre and post-operative evaluation schedule.
* Patients with only one lower limb arthroplasty

Exclusion Criteria:

* Patient with metabolic bone diseases, use of steroids or other drugs affecting bone metabolism
* Patients with osteoporosis (pre-op T-score \< -2,5)
* Patients with significant comorbidities
* Patients with both hip and knee arthroplasty
* Patients with restricted mobility
* Patient with severe hip contracture
* Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study

Primary outcomes:
measure: Compare Periprosthetic Bone Mineral Density (BMD), at 1y Postoperative, in Patients That Have Undergone a Total Hip Arthroplasty (THA) Via the Direct Anterior Approach Receiving Either a Quadra or AMIStem Femoral Component.
timeFrame: 0-12 months
Secondary outcomes:
measure: Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score
timeFrame: 6 weeks, 6 months, 1 year
measure: Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score.
timeFrame: 6 months, 1 year
measure: Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
timeFrame: 6 months, 1 year
Other outcomes:
Locations:
city: Dillingen an der Donau
country: Germany
facility: St. Elisabeth Dillingen
state: Bayern
Study officials:
affiliation: DGOOC; BVO; BVASK
name: Martin Nolde, Dr. Med.
role: PRINCIPAL_INVESTIGATOR
References: