louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04394702: Single-file Pulpectomy in Primary Molars
Official title: Efficacy of One-Shape Single-file System in Pulpectomy of Infected Primary Molars: In-vitro and In-vivo Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulpal Necrosis
Keywords: Pulpectomy
Pediatric Dentistry
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 94
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study evaluates the rotational One Shape single-file system regarding clinical and radiographic outcomes in root canal treatment of infected primary molars.

This randomized clinical trial was carried out on 94 primary molars on children in the age group from 4 to 6 years. The teeth selected for this study were randomly assigned into 2 groups according to the used endodontic preparation system. Group I: 47 primary molars were instrumented with One Shape rotational single-file system. Group II: 47 primary molars were instrumented with stainless steel K-files. All teeth were evaluated clinically and radigraphically for 12 months with periodic recall at 3, 6 and 12 months.


Eligibility criteria: Inclusion Criteria:

* Children categorized as class I or II according to American Society of Anesthesiologists (ASA).
* Children aged between 4 and 6 years with at least one necrotic primary second mandibular molar.
* History of dull toothache over an extended period of time
* History of spontaneous pain or pain at night
* Swelling adjacent to tooth with or without a sinus tract
* Abnormal tooth mobility
* Presence of necrotic pulp tissue or purulent discharge when the pulp chamber was accessed
* Interruption of lamina dura or thickening of periodontal ligament space
* Furcational radiolucency did not surpass half of the distance between the furcation and permanent successor
* Negative findings of internal root resorption
* External root resorption confined to the apical third and with at least two-thirds of the root length was intact

Exclusion Criteria:

* Uncoperative children or parents/legal guardians
* Sever intellectual, behaviour or emotional problems
* Non-restorable tooth crowns
* Root canal obliteration
* Presence of underlying dentigerous or follicular cysts

Primary outcomes:
measure: Pain presence or absence
timeFrame: one year
measure: swelling presence or absence
timeFrame: one year
measure: radiographic success or failure
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University, Faculty of Dentistry.
Study officials:
References:
Clinical trial NCT05748002: Evaluation of Morphology Abnormal Cornea Stability With Corneal Biomechanical
Official title: Prediction for Abnormal Topography Corneas Using New Biomechanical Parameter - Biomechanical Stable Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus, Stable
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 315
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients premedicated for refractive surgery

Brief summary: To evaluate the corneal biomechanical properties of stable eyes with abnormal morphology, and introduce a biomechanical stable index to evaluate the stability of the eyes with abnormal morphology at the first diagnosis.


Eligibility criteria: Inclusion Criteria:

1. Best corrected visual acuity (BCVA) ≥ 20/20;
2. No other eye diseases except myopia and astigmatism;
3. The cornea was transparent, and there was no cloud or pannus;
4. No clinical manifestation of keratoconus（Corneal stromal thinning, Cone-shaped anterior protrusions, Fleischers ring, Vogts striae, Epithelial or subepithelial scarring） Exclusion Criteria:1) corneal disease;

2) ocular trauma; 3) Patients were required to stop wearing soft contact lenses for at least 2 weeks and rigid contact lenses for at least 4 weeks before examination; 4) Pregnant and lactating women;

Primary outcomes:
measure: stable
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tiajin Eye Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Eye Hospital
name: Yan Wang, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT03952702: Overminus Lens Therapy in Intermittent
Official title: The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intermittent Exotropia
Myopia Overcorrection
Over-minus Therapy
Myopia Progression
Keywords: Intermittent exotropia
overminus lens therapy
myopic overcorrection
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 65
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive pediatric patients diagnosed with IXT and prescribed overminus lenses

Brief summary: In this prospective study, entitled "The Long-Term Efficacy of Overminus Lens Therapy in Intermittent Exotropia",the investigators examined the long-term impact of overminus lenses on the management of intermittent exotropia (IXT), treatment effect after overminus treatment has been discontinued and also investigated if overminus lenses cause myopia in long-term.

Detailed description: Purpose: To evaluate the long-term impact of overminus lenses in intermittent exotropia (IXT), to determine if the treatment effect would persist after overminus minus lenses are discontinued and also to investigate if overminus lenses cause myopia.

Materials and Method: Sixty-five consecutive cases of IXT followed for at least 48 months were included. Patients with a history of previous surgery, ocular pathology, convergence insufficiency, severe myopia (\>-5.0 D), severe hyperopia (\>+5.0 D), moderate or severe amblyopia and poor compliance with spectacles were excluded. Data was collected including near stereoacuity, AC/A ratio, control of IXT measured with Newcastle Control Score (NCS) at baseline and in all follow-up visits. Baseline values without overminus threapy were compared with postintervention values at every visit.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with IXT
* prescribed overminus lenses

Exclusion Criteria:

* a history of previous surgery, ocular pathology
* convergence insufficiency type IXT
* presence of any type of ocular deviation except IXT
* presence of severe myopia (greater than -5.0 D)
* presence of severe hyperopia (greater than +5.0 D)
* presence of moderate or severe amblyopia
* poor compliance with overminus spectacles
* follow up period of \<48 months after intervention.

Primary outcomes:
measure: The long-term effect of overminus lenses in fusional capacity of patients with intermittent exotropia.
timeFrame: 4 years
measure: The long-term effect of overminus lenses on stereopsis of patients with intermittent exotropia.
timeFrame: 4 years
measure: The long-term effect of prescribing overminus lenses on refractive changes.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University Faculty of Medicine
Study officials:
References:
Clinical trial NCT05806502: Arginase Inhibition in Type 1 and Type 2 Diabetes Mellitus
Official title: The Effect of Arginase Inhibition on Vascular Endothelial Function in Patients With Type 1 and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the efficacy of arginase inhibition on endothelial function in patients with type 1 diabetes and type 2 diabetes.

Detailed description: Detailed Description:

The study is performed on one group of patients with type 1 diabetes and one group of patients with type 2 diabetes.

Forearm blood flow is determined by venous occlusion plethysmography. Endothelium-dependent vasodilatation is determined during intra-brachial artery infusion of serotonin (21, 70 and 210 ng/min). Endothelium-independent vasodilatation is determined by infusion of sodium nitroprusside (SNP; 1, 3 and 10 µg/min). Each dose is given for 2 min at a rate of 2.5 ml/min. Data are expressed as percentage change in forearm blood from baseline flow.

Twelve subjects are included in each group. On the day of the study the subject arrives to the laboratory after having a light breakfast. Forearm vessels of the non-dominant arm are cannulated and forearm blood flow is determined as described above. Baseline endothelium-dependent and endothelium-independent vasodilatation is determined by intra-arterial infusions of serotonin and SNP, respectively. Thereafter an intra-arterial infusion of the arginase inhibitor N-omega-hydroxy-nor-l-arginine (nor-NOHA) is administered as an intra-arterial infusion at a rate of 0.1 mg/min and is maintained for 120 min. The dose is based on a previous study by our group demonstrating improved endothelial function. Endothelium-dependent and -independent vasodilatation is reassessed at 120 min of infusion.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Type 2 diabetes

Exclusion Criteria:

* Age \>80 years
* Acute coronary or ischemic event during the last three months
* Vascular surgery of the arm
* Peripheral vascular disease affecting the arm
* Ongoing anticoagulant medication
* Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol.

Primary outcomes:
measure: Endothelium-dependant increase in forearm blood flow
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: John Pernow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01409902: Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue
Official title: Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Prolapse
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: excessive vaginal tissue

Brief summary: The main objective of the study is to assess the effectiveness of the sheathed speculum in providing adequate visualization and access to the cervix in patients with excessive vaginal tissue.

The secondary objective is to rate the patient's comfort evaluation during the sheathed speculum examination.

Detailed description: This is a descriptive clinical trial designed to assess the efficacy of a sheathed speculum in providing adequate visualization and access to the cervix in women with excessive vaginal tissue. Eligible, consented subjects who fail their initial speculum examination (because their cervix is not visualized due to the collapse of loose lateral vaginal walls) will have a sheathed speculum examination instead of the standard-of-care exam whereby the clinician fabricates a solution at the bedside (condom with tip cut placed on speculum, concomitantly using an additional instrument like a lateral-wall retractor, glove with tip of thumb placed over the speculum, using the largest speculum available)

Eligibility criteria: Inclusion Criteria:

* Age 18 to 64 years
* BMI greater than 30 (or see next line)
* Collapsing vaginal tissue preventing the visualization of the cervix (meeting this criterion in the absence of a BMI \>30 would also qualify the patient for the study).
* Able to provide written informed consent

Exclusion Criteria:

* Patients unwilling to participate in the study or provide consent Presence of significant acute pelvic pain syndromes (ie exacerbation of dyspareunia, chronic pelvic pain or pelvic floor dysfunction, atrophic vaginitis, interstitial cystitis, endometriosis) which, in the opinion of the examining clinician, could potentially confound the patient's responses to the questionnaire
* Presence of active genital herpes
* Presence of significant condyloma acuminata (may be an investigator decision)
* Any other patient deemed inappropriate for the study by the consenting or examining investigator.

Primary outcomes:
measure: Number of patients with adequate visualization and access to cervix or vaginal vault
timeFrame: At time of speculum exam
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF STC
state: Florida
Study officials:
affiliation: University of South Florida
name: Erich Wyckoff, M
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03454802: Passive Leg Raising - an Important Diagnostic Manoeuvre
Official title: Passive Leg Raising - an Important Diagnostic Manoeuvre and Its Dependency on the Activity of the Autonomous Nervous System in Critically Ill Patients and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Insufficiency
Lead sponsor: Region MidtJylland Denmark
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2018-03-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim is to describe the physiological background for PLR and the interpretation of a PLR manoeuvre.

The protocol entails the measurement of stroke volume (SV) at baseline (semirecumbent patient position), during PLR and after returning to semirecumbent position. Simultaneously blood pressure (BP), pulse rate (PR), pulse oximetric saturation (SpO2) and ECG are recorded. The procedure is performed in ten normal subjects, ten patients recruited in the cardiology outpatient department and ten critically ill patients under analgosedation in the ICU.

Analysis includes changes in measured variables and heart rate variability in the frequency domain during the three phases of the experiment.

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

Consenting after written and oral information

Exclusion Criteria:

Contraindications to PLR: intracranial or abdominal hypertension

Primary outcomes:
measure: Changes in cardiovascular variables I
timeFrame: 10 minutes
measure: Changes in cardiovascular variables II
timeFrame: 10 minutes
measure: Changes in cardiovascular variables III
timeFrame: 10 minutes
measure: Changes in cardiovascular variables IV
timeFrame: 10 minutes
measure: Changes in HRV frequency domain variables V
timeFrame: 10 minutes
measure: Changes in HRV frequency domain variables VI
timeFrame: 10 minutes
measure: Changes in HRV frequency domain variables VII
timeFrame: 10 minutes
measure: Changes in HRV frequency domain variables VIII
timeFrame: 10 minutes
measure: Changes in HRV frequency domain variables IX
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Regionshospitalet Silkeborg
state: Midtjylland
Study officials:
affiliation: Head of Centre of Planned Surgery, Silkeborg Regional Hospital
name: Peter Toft, MD
role: STUDY_CHAIR
References:
citation: Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.
Clinical trial NCT03740802: Hypophosphatemia as a Predictor in Surgical Resuscitation Sepsis
Official title: Evaluation of Hypophosphatemia as a Predictor of Sepsis in Surgical Resuscitation Units.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypophosphatemia
Infection
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to 15-bed surgical ICU between January 1, 2015 and June 31, 2015 were screened for inclusion.

Brief summary: Retrospective study in the surgical intensive care unit of the Brest Teaching Hospital (France) during a 6-months period (January 2015 -May 2015) to study the independent association between hypophosphatemia and 28-day infection.


Eligibility criteria: Inclusion Criteria:

* Adults

Exclusion Criteria:

* Less than 18 years old
* Infected at admission

Primary outcomes:
measure: Number of patients with sepsis within 28 days after ICU admission
timeFrame: 28 days since the ICU admission
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT04199702: Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation
Official title: Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Catheter ablation with pulmonary vein (PV) isolation is a commonly performed strategy employed for the treatment of atrial fibrillation. The conventional approach for post-procedure care has been for the patient to stay overnight and be discharged the next day. However, the overall incidence of procedure related complications of catheter ablation for atrial fibrillation in high volume centers is low. New technologies have been introduced and improve the safety of the ablation procedure. Discharging patients the same day after ablation is a practice that's currently followed by many centers in the United States and abroad. The investigators' hypothesis is that the currently available advanced technologies allow for the same-day safe discharge of patients after catheter ablation. The investigators propose a prospective single-arm study to evaluate the feasibility and safety of the same-day discharge after AF ablation at MGH. The protocol of same-day discharge will include the use of a commercially available venous closure device, early ambulation, bed-side echocardiogram, and follow-up phone calls at day 1 and 3 post-procedure.


Eligibility criteria: Inclusion Criteria:

* Age \>18 - Age \< 75 yr
* Documentation of atrial fibrillation (AF) or atypical atrial flutter
* All patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements

Exclusion Criteria:

* Heart failure with reduced ejection fraction less than 40%
* Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
* INR \> 4.0 at the time of the procedure
* Mental impairment precluding verbal consent or completing follow up
* Patients with any other significant uncontrolled or unstable medical condition
* Women who are known to be pregnant or have had a positive β-HCG test within 7 days prior to procedure
* Presence of left atrial thrombus
* Patients with prior prostate hypertrophy or bladder surgery
* BMI \> 40 or BMI \<20
* Patients with h/o symptomatic heart failure
* Patients with severe aortic stenosis (AS) or severe mitral regurgitation (MR)
* Patients who require femoral arterial line for blood pressure monitoring

Primary outcomes:
measure: The rate of successful same day discharge after AF ablation procedure
timeFrame: Day of the AF ablation procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT04774302: Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients With NAFLD
Official title: Study of Correlation Between Hepatic Fibrosis and Cardiovascular Risk Evaluated by Non-invasive Tests in Patients With Nonalcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NAFLD
Keywords: CAC score
Liver fibrosis
Cardiovascular risk
Metabolic syndrome
Lead sponsor: Clinique Pasteur
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 292
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: Male or female evaluated in a dedicated hepatology day hospital, as part of a first diagnostic workup or follow-up for already known NAFLD

Brief summary: This study aims to examine the link between Non-Alcoholic Fatty Liver Disease (NAFLD) and cardiovascular diseases by studying the association between liver fibrosis degree and cardiovascular risk factors. The study would clarify the value and the role of the Coronary calcium score (CAC score) in the screening for coronary disease in this population at high cardiovascular risk.

Detailed description: Hepatic Fibrosis and Cardiovascular Risk are evaluated by non invasive tests

Eligibility criteria: Inclusion Criteria:

* NAFLD patients regardless of disease stage of severity (from simple steatosis to cirrhosis)
* Patient without known heart disease
* Patient agreeing to participate and who has given his non opposition

Exclusion Criteria:

* Association with another cause of liver disease
* Already known coronary artery disease
* Pregnancy or breastfeeding in progress

Primary outcomes:
measure: Coronary calcium score
timeFrame: At inclusion
measure: Shear wave liver elastography
timeFrame: At inclusion
Secondary outcomes:
measure: ARFI Hepatic elasticity
timeFrame: At inclusion
measure: Cardiovascular risk
timeFrame: At inclusion
measure: Coronary heart disease
timeFrame: 3 month
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Clinique Pasteur
name: Maeva GUILLAUME, MD
role: PRINCIPAL_INVESTIGATOR
References: