cyrilzakka/clinical-trials huggingface dataset:
Clinical and Radiographic Evaluation of Resin Endocrown as Long Term Interim Restoration Versus Stainless Steel Crown for Endodontically Treated First Permanent Molar in Children: Randomized Controlled Pilot Study.

management of endodontically treated first permanent molar with deep dental caries is one of the challenging procedure that the operator face. Using resin endocrown or stainless steel crown restoration to make comparison which one is more successful in children.

Diagnostic procedure:

Diagnosis of the cases will be performed according to guidelines of AAPD 2017 for treatment of irreversible pulpitis and necrotic pulp therapy in mandibular first permanent molar . Preoperative periapical radiograph will be taken

Intra operative procedure:

Local anaesthesia administration using articaine 4% with epinephrine 1:100000. Rubber dam application and access cavity preparation will be established using a sterile bur. Root Canal Treatment will be done and then the dental orifices of the pulp chamber will be sealed using a flowable composite.

The immediate postoperative radiograph will be done to reveal optimal root canal treatment.

In the intervention group:

The preparation of cavity design will be as following:

Preparation of occlusal surface will be done with wheel stone to create 2 mm occlusal clearance; the occlusal surface will be prepared flat to create a butt-joint. The junction between the occlusal and mesial cavity will be rounded to produce cervical side walk. • Divergence of the inner cavity walls will be obtained using a tapered stone with a rounded end (TR- Dia Bur Mani).

Impression will be taken for the prepared tooth structure using addition silicone material (Elite HD Zermach, Italy), stone model will be poured for fabrication of endocrown to allow for blockage of any undercuts in the pulp chamber cavity. Finished final endocrown restoration will be cemented in place using self-adhesive universal dual cured resin cement (rely X Unicem, 3M, USA).

In the control group tooth preparation will be made as follow:

By reducing mesial, distal and occlusal surface. The crown margin will be placed just apically to the gingival margin and carefully adjusted to give an accurate fit in this region. The crown will be cemented with glass ionomer cement.

Follow up:

Clinical and evaluation will be performed at 1 st week, 3, 6, 9 and 12 months. Radiograph evaluation will be performed at, 1 st week, 6 and 12 months

Eligibility Criteria:
Inclusion Criteria:

* Cooperative children in age range from 10 to 13 years

  * Mandibular first permanent molar indicated for root canal treatment with closed apex.
  * Presence of at least two to three sound walls of tooth.
  * Absence of internal or external pathologic root resorption.
  * Normal occlusion without any para-functional habits.
  * Parent or guardian agree for participant in the study

Exclusion Criteria:

* Excessive mobility.
* Children with underlying systemic disease.
* Children with special health care needs.
* Poor oral hygiene.
Telemonitoring Versus Usual Care

Background: Older adults with multiple chronic illnesses are at risk for worsening functional and medical status with ensuing hospitalization. One goal of medical care is to prevent this decline. One method that may help slow this functional and medical decline is home telemonitoring.

Specific aim: To determine the effectiveness of home telemonitoring compared to usual care in reducing combined outcomes of hospitalization and emergency room visits in an at risk population over 60 years of age.

Materials and Methods: This will be a randomized trial of 200 patients into one of two interventions. Home telemonitoring involves the use of a computer device at home which records biometric and symptom data from patients. This information is monitored by mid level providers associated with the primary care medical practice. Usual care involves patients who make appointments with their providers as problems arise and utilize ongoing support like a 24 hours nurse line. The study participants are adults over 60 years of age within the highest 10% on elderly risk assessment (ERA) scores. Patients will have initial evaluations of gait, quality of life (SF12), Kokmen test of mental status, and PHQ 9. Patients will be followed for 1 year for primary outcomes of hospitalizations and emergency room visits. Secondary analysis will include quality of life, compliance with the device and attitudes about telemonitoring. Sample size is based upon an 80% power to detect a 36% difference between the groups. The primary analysis will involve Cox proportional time to event analysis comparing both interventions for telemonitoring or usual care. Secondary analysis will use T-test comparisons for continuous variables (quality of life, attitudes) and chi square for proportional analysis.


Eligibility Criteria:
Inclusion:

1. at least 60 years of age;
2. have an Elder Risk Assessment (ERA) Index score of 16 or greater;
3. Are able to participate fully in all aspects of the study;
4. Have been provided with, understand, and have signed the informed consent;

Exclusion:

1. patients who are currently residing in a nursing home
2. patients with a clinical diagnosis of dementia
3. patients with a score of ≤29 on the Kokmen short test of mental status
4. patients for whom we cannot obtain informed consent.
5. patient under the age of 60 will also be excluded from participating.
6. patients who have not granted Universal Research Authorization to use medical records.
7. patients will also be excluded if the subject would not be able to use the interventional machine
Early Orthodontic Treatment of Dental Crowding

Aim of the study is to compare treatment duration and effects of orthodontic treatment of dental crowding between treatments started at different stages of mixed dentition phase. The randomized controlled trial study will be conducted in a public health care center.


Eligibility Criteria:
Inclusion Criteria:

* Dental developmental stage of mixed dentition
* Crowding on both dental arches
* Skeletal discrepancy not suspected

Exclusion Criteria:

* National criteria for publicly funded treatment not met by the severity of the malocclusion
* Other malocclusions
* Angle Class III relationship of the molars
* Malocclusion related to a syndrome
* Non-compliance to orthodontic treatment
Sentinel Lymph Node Technique in Multifocal Breast Cancer

The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer

The sentinel lymph node is located preferentially by:

* association of subareolar injection of technecium and blue dye
* or, in case of blue dye allergy, by the subareolar injection of technecium only
* or, in case of no possibility of radioactive isotope subareolar injection , by blue dye injection only This procedures are made the day before the surgery or the day of the surgery
* This procedure is immediately follows by complete axillary dissection during breast surgery
* The anatomopathologic analysis of the 2 samples (sentinel lymph node and axillary dissection) and the histologic confirmation on the removed tumor of the multifocal nature of the breast cancer correspond to the end of the study for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Multifocal invasive breast cancer
* At least 2 focuses (clinically and/or by mammography or ultrasound)
* Proven by pre-surgical histology (on 1 focus at least)
* Age \> 18 years old
* Clinically negative axillary lymph nodes
* No treatment before surgery
* Signature of written informed consent

Exclusion Criteria:

* Multifocality proven after surgery
* Non invasive breast cancer
* Inflammatory breast cancer
* Axillary lymph node
* Metastatic disease
* Previous homolateral breast cancer
* Dementia or alterated mental status
* Pregnant or lactating woman
A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer

The purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (PD-L1)-positive cervical cancer (metastatic and/or recurrent).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix after progression on or after 1-2 lines of prior systemic chemotherapy in the metastatic/recurrent setting that is not amenable to curative treatment with systemic chemotherapy, surgery, and/or radiotherapy
* Radiologically-measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance Status of 0 or 1
* Cervical cancer tissue for study analysis (archival or fresh biopsy specimen)
* Life expectancy of at least 12 weeks
* Adequate hematologic and organ function
* Female of childbearing potential must be willing to comply with adequate contraception

Exclusion Criteria:

* Treatment with investigational therapy with therapeutic intent within 28 days prior to randomization
* Active or untreated central nervous system (CNS) or brain metastases
* Active or history of autoimmune disease or immune deficiency
* Active tuberculosis
* Known, clinically significant liver disease
* Severe infection per investigator judgement at the time of randomization or any active infection that, in the opinion of the investigator, could impact patient safety
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
* Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to randomization
* Treatment with systemic immunosuppressive medications within 1 week prior to randomization or anticipation of need for systemic immunosuppressive medication during study
* Pregnant or breastfeeding woman
* Known hypersensitivity to any component of the tiragolumab or atezolizumab formulations
Dose Ranging Trial to Determine the Safety and Efficacy of EMA401 in Patients With PHN

The study is a randomized, double blind, placebo-controlled, parallel-group comparison (two dose levels of EMA401 versus a placebo group), of safety and efficacy in patients with postherpetic neuralgia.

Screening Period (Up to Four Weeks) to confirm eligibility for the study which will be determined by Screening tests, physical examination/medical history and fulfillment of eligibility criteria including assessment of pain.

Study Period (14 Weeks) Approximately 360 eligible male and female patients will receive double-blind treatment for 14 weeks. Patients will be randomized in a 1:1:1 ratio to treatment with EMA401 100 mg BID, 300 mg BID or placebo.

Patients will attend the study site at the end of the Baseline visit and end of Weeks 1, 3, 5, 7, 9, 11, 13, and 14 for on-study assessments.

Eligibility Criteria:
Inclusion Criteria:

* Be diagnosed as suffering from PHN defined as pain in the region of the rash persisting for more than six months after onset of herpes zoster rash.
* Be assessed as suffering from moderate to severe pain across the Screening Period. The assessment of moderate and severe pain will be made using an algorithm proprietary to Spinifex. The Investigator/site staff will be informed immediately as to whether the patient is eligible or ineligible on the ePRO website based on the patient entering all relevant pain scores in the eDiary device.
* Women of child bearing potential (WOCBP) must have a negative urine pregnancy test at the Screening Visit (Visit 1) and within 72 hours prior to administration of IP.

Exclusion Criteria:

* Patients taking any topical treatment for their PHN at the time of Screening Visit 2 will be excluded, including lidocaine plaster, capsaicin patch, and any other topical preparations of these or any other topical medications (e.g., aspirin, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)) for their PHN.
* Have a blood pressure reading, after resting for at least five minutes, outside a systolic blood pressure range of 84-151 mmHg or a diastolic blood pressure \> 95 mmHg. If the blood pressure is outside of the range, a repeat measurement can be taken after the patient has rested. The repeat measurement should be used as the screening value.
* Have serum aspartate transaminase (AST) or alanine transaminase (ALT) levels \> 1.5 x the upper limit of normal or have total bilirubin concentrations \> 1.5 x the upper limit of normal at Screening (Visit 1).
* Patients who have a known diagnosis of diabetes and are stable on medication with a hemoglobin A1c \> 8%. Those who do not have a known diagnosis of diabetes with a hemoglobin A1c \> 7%.
* Have active herpes zoster upon physical examination at Screening (Visit 1) or during the study.
* Known history of, or positive laboratory result for hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection as defined by being seropositive for hepatitis B surface antigen (HBsAg), HCV antibodies or HIV antibodies respectively.
AK104 Plus Concurrent Chemoradiation Therapy in Esophageal Squamous Cell Carcinoma

The purpose of this study is to assess the safety and efficacy of AK104 plus concurrent chemoradiation therapy in unresectable locally advanced esophageal squamous cell carcinoma

AK104 10mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5), once every 3 weeks (Q3W), induction treatment for 2 cycles; Subsequently, AK104 10 mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5) is combined with radiotherapy(50Gy/25F) for 2 cycles. Assess disease efficiency( objective response rate; disease control rate; duration of overall response; time to resolve) and safety( adverse event).

Eligibility Criteria:
Inclusion Criteria:

* unresectable locally advanced esophageal squamous cell carcinoma; ECOG PS 0-1; At least one measurable lesion according to RESIST standard 1.1； not received anti-tumor treatment in the past

Exclusion Criteria:

* received immunotherapy in the past； Active hepatitis B, hepatitis C and other infectious diseases； Severe liver and kidney function, cardiovascular and cerebrovascular abnormalities
Clinical Validation of the Apollo Daily Disposable Soft Contact Lenses

The purpose of this study was to confirm the design specifications of a Test lens and validate its clinical performance.

This was a double-masked, randomized, bilateral two-day crossover, dispensing study design. Subjects were randomized to wear the Test lens or Control lens bilaterally in random order and on a daily wear, single-use basis for a period of 2 days each.

Eligibility Criteria:
Inclusion Criteria:

* Has had a self-reported oculo-visual examination in the last two years.
* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and understood the information consent letter.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is an adapted soft contact lens wearer, having worn contact lenses for a minimum 4 weeks prior to the study
* Has spectacle cylinder ≤1.00D in both eyes.
* Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
* Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/20 in each eye.
* Wears CLs in both eyes (monovision acceptable, but not monofit)
* Has clear corneas and no active ocular disease.
* Has not worn lenses for at least 12 hours before the examination
* Is willing to wear the study contact lenses for a minimum 8 hours on at least two consecutive days for each study pair.

Exclusion Criteria:

* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Is using any concomitant systemic or topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye-related clinical or research study.
A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers

This randomized, double-blind, placebo-controlled, cross-over study will assess the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. In Part 1, subjects will be randomized to receive single ascending doses of either RO5508887 or placebo. In Part 2, subjects will receive a single dose of RO5508887 on two occasions, with or without food. Anticipated time on study is up to 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, 18-45 (Part 1) or 18-65 (Part 2) years of age inclusive; healthy status is defined by absence of evidence of any active or chronic disease
* Body Mass Index (BMI) 18 to 30 kg/m2 inclusive
* Male subjects must use a barrier method of contraception for the duration of the study and for 30 days after the last dose

Exclusion Criteria:

* Suspicion of regular consumption of drugs of abuse
* Regular smoker (\>5 cigarettes, \>1 pipeful or \>1 cigar per day)
* Positive for hepatitis B, hepatitis C or HIV infection
* History of hypersensitivity or severe drug reaction
* Participation in an investigational drug or device study within three months before the first drug administration
The Comparison of Warming Techniques in Patients Undergoing Open Abdominal Surgery in Litotomy Position

The patients scheduled to undergo major abdominal surgery in litotomy position will be randomized into two groups in order to compare the effects of two warming techniques during the intraoperative period.

The patients will be randomized into two groups. All patients will receive prewarming with forced-air warming device for 30 minutes. All patients will receive warmed fluids during intraoperative period. One group will receive warming with only forced-air warming device and the other group will receive warming with both forced-air warming device and water mattress. Timpanic, esophageal and peripheral temperature monitoring will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Major abdominal surgery in litotomy position
* ASA I-II
* Anticipated operation time over 1 hour

Exclusion Criteria:

* Sepsis
* Hypothermia
* Hyperthermia
* Malignant Hyperthermia
* Tyroid dysfunction
Complex Ocular Infection, Optimization of Microbiological Diagnosis

The purpose of this study is to evaluate the impact of different technique to optimize the microbiological diagnosis of the COI.

* Metagenomic for the endophtalmitis
* Multiplex polymerase chain reaction for corneal abscesses

Microbiological diagnosis of complex ocular infection (COI) (i.e: endophtalmitis and corneal abscess) is a current challenge. Indeed, endophtalmitis are often germ-free because a lack of microbiological diagnosis due to small volume to analyze and a complex site to attain. The microbiological etiologies of corneal abscesses are more frequently identified.

Since few years, new molecular tools are developed in infectious diseases to optimizing the microbiological diagnosis. The investigators implemented these techniques in our hospital to optimize the microbiological diagnosis of complex ocular infection (COI). Thus, endophtalmitis benefit, when the volume of the ocular sample is sufficient, of molecular techniques (16s PCR and metagenomic shotgun). Corneal abscesses could shortly benefit of multiplex PCR in order to reduce the time to diagnosis.

The impact and accuracy of these techniques is unknown.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Patient presenting or having presented a clinical suspicion of complex ocular infection requiring a sample for microbiological diagnosis:

  * Corneal abscess requiring hospitalization
  * Any suspicion of endogenous or exogenous endophthalmitis.
* Patient not opposed to participating in the research

Exclusion Criteria:

* Patient under guardianship or curatorship
* Pregnant women
Safety and Efficacy of Neoadjuvant Radiochemotherapy in Adenocarcinoma of the Gastric-oesophageal Junction

The purpose of this study is to determine the dose limiting toxicity and the maximum tolerable dose of the radiochemotherapy with Docetaxel and Oxaliplatin in patients with adenocarcinoma of the gastric-oesophageal junction.

Radiotherapy starts on day 1 of chemotherapy after the application of Docetaxel and Oxaliplatin and will be administered in single doses of 1.8 Gy once daily and five times a week for 5 weeks.

In the sixth treatment week a boost of 3 further radiations with 1.8 Gy will be applied.

Simultaneous chemotherapy:

Initially, in part A of the study the maximum tolerable dose (MTD) for the simultaneous chemotherapy will be identified with a 3-step dose escalation scheme:

Level 1: Docetaxel: 20 mg/m2 Oxaliplatin 40 mg/m2 i.v., Level 2: Docetaxel: 20 mg/m2 Oxaliplatin 50 mg/m2 i.v., Level 3: Docetaxel: 25 mg/m2 Oxaliplatin 50 mg/m2 i.v.,

The treatment starts with 3 patients in level 1. If no dose limiting toxicities appear, it will be switched to dose level 2. The same applies for the switch from level 2 to level 3. If a DLT appears on one level, a further 3 patients will be treated within this dose level.

If in one level at least 2 of 6 patients show DLT, the subjacent level will be defined as the maximum tolerable dose (MTD).

Eligibility Criteria:
Inclusion Criteria:

* adenocarcinoma of gastric-esophagal junction
* stage II to III
* unidimensional measurable disease

Exclusion Criteria:

* surgery of primary tumor
* metastasis
* prior chemo- or radiotherapy
Comparison of Acceleromyography (AMG) and Mechanomyography (MMG) for Establishing Potency of Neuromuscular Blocking Agents

The purpose of this study was to compare two methods for neuromuscular monitoring, acceleromyography and mechanomyography for establishing the dose-response relationship and the potency of a neuromuscular blocking agent using rocuronium as an example. We hypothesized that there would be no significant difference between potencies estimated using acceleromyography and mechanomyography.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Ideal weight +/-20%
* Both arms available for neuromuscular monitoring
* Surgery in supine position
* Participated surgery time more than 30 min

Exclusion Criteria:

* Pregnant and breast-feeding women
* Patients with known illness or use of medications known to influence the neuromuscular transmission
* Known significant renal or hepatic dysfunction
* Allergy to medications used in the study
Effects of Replacement Therapy With Sexual Steroid Hormones on the Insulin Sensitivity of Hypogonadal Man

Sexual steroids administered to supra-physiological doses are likely to change the carbohydrate and lipid metabolism.

Investigators propose to study in 12 hypogonadal men hypogonadotropic or hypergonadotropic treated with aromatase inhibitor, the respective effects of estradiol, testosterone or both steroids administered in a cross-over Latin squares plan on insulin sensitivity measured by the reference method of the hyperinsulinemic euglycemic clamp.


Eligibility Criteria:
Inclusion Criteria:

* Hypogonadism hypogonadotropic or hypergonadotropic
* Man aged 18-60 years
* BMI between 18 and 27.

Exclusion Criteria:

* Other ante-pituitary deficiency
* Chronic treatment modifying carbohydrate metabolism (thiazides, beta 2 mimetics, steroids ...)
* Diabetes
* Obesity diffuse or android
* Hemochromatosis
* osteoporosis
* chronic diseases
* neoplasia
* High blood pressure