cyrilzakka/clinical-trials huggingface dataset:
Assessment of Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Using Two Revascularization Protocols. (In Vivo Study)

Regenerative endodontic procedures have been used to successfully treat human mature permanent teeth with necrotic pulps and apical periodontitis. Many researchers have begun to apply regenerative endodontic procedures to mature teeth in adult patients. Several clinical case reports have shown complete resolution of signs and symptoms of pulp necrosis in mature teeth, even those with large periapical lesions, as well as signs of pulp canal obliteration. thevaim of this study is To assess the regenerative potential of mature permanent teeth with necrotic pulps with platelet-rich fibrin (PRF) and blood clot using radiographic and clinical methods.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mature teeth.
* Patients with periapical periodontitis.
* Maxillary anterior teeth only will be involved.
* Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
* Patients who will agree to the consent and will commit to follow up period.

Exclusion Criteria:

* Patients with immature roots.
* Patients with any systemic disease that may affect normal healing.
* Patients with swelling.
* Pregnant females.
* Patients who could/would not participate in a 1 year follow up.
* Patients with fistula.
* Patients with old age.
* Teeth with periodontal involvement.
* Teeth with vertical root fractures.
* Unrestorable teeth.
Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis

Due to screening, T1N0 early-stage breast cancer now accounts for more than 50% of the tumors diagnosed in France. The prognosis of these tumors is good, even excellent in women ≥ 65 years of age, with specific survival of 98% at 5 years.

The treatment of these tumors combines breast-conserving surgery and external whole breast irradiation for 6.5 weeks.

A true de-escalation of treatment is taking place with these tumors, both surgically and medically. Surgery therefore now prefers breast-conserving methods in combination with exeresis of the sentinel lymph node only. In the same way, in many international studies, radiotherapy has been evaluating the possibility of reducing both:

* the irradiation volume at the excision site (partial irradiation)
* the duration of this irradiation (accelerated radiotherapy)

Between 2004 and 2007, the CRLC \[Regional Anti-Cancer Center\] evaluated the feasibility and the oncological results of intra-operative partial irradiation via a phase II study in women 65 years of age and older with T1N0M0 hormone-sensitive tumors with a good prognosis.

From 2010 to 2013, the ICM carried out an observational study of these tumors with an excellent prognosis.

In July 2009, the American Society for Radiation Oncology (ASTRO) published a consensus statement with specific recommendations and indications for accelerated partial breast irradiation (APBI).

This APBI technique has been developing in France over the past 5 years within the framework of clinical studies and in compliance with the 2012 recommendations of the French National Cancer Institute. This APBI can be given by 3D external radiotherapy or, as in this study, by intra-operative radiotherapy (IORT) in order to obtain optimal precision and spare as much of the surrounding healthy tissue as possible.

The Investigator therefore propose a cohort study to prospectively analyze the results of this technique applied to the indications strictly defined by the ASTRO.

after registration, particpants have as treatment "combination extended tumorectomy with axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial irradiation at the tumor site.

follow up after this treatment during 5 years

Eligibility Criteria:
Inclusion Criteria:

* Women 60 years of age or older,
* Histologically proven invasive ductal breast cancer or of a histologically favorable sub-type (mucinous, tubular or colloid),

  -. Unifocal tumor,
* T1 (diameter ≤ 20 mm),
* N0 (pN0 or pNi+),
* M0,
* Gland exeresis margins ≥ 2 mm,
* Estrogen receptor positive,
* Information and non-opposition of the patient.

Exclusion Criteria:

-. Inflammatory breast cancer,

* Associated peri-tumoral lymphatic emboli
* Associated extensive intra-ductal component
* Invasive lobular carcinoma
* Pure ductal carcinoma in situ,
* Sarcoma or lymphoma-type non-epithelial tumor
* Synchronous bilateral breast cancer,
* Any prior neo-adjuvant treatment: radiotherapy, chemotherapy, hormone therapy
The Effect of Reloading Prasugrel in a Patient Who Has Already Received a Loading Dose (LD) of Clopidogrel

The primary objective of this study is to compare platelet reactivity between patients receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients receiving only a loading dose of prasugrel.

This is a prospective, open-label, non-randomized trial of approximately 260 patients with Acute Coronary Syndrome (ACS) undergoing percutaneous coronary intervention (PCI). In order to compare platelet reactivity, as assessed by the VerifyNow P2Y12 assay, we plan to recruit two study groups of interest:

1. Patients who have already received a 600 mg loading dose (LD) of clopidogrel in preparation for PCI will receive a loading dose of 60 mg of prasugrel.
2. Patients who have not received a LD of clopidogrel will receive a 60 mg LD of prasugrel prior to PCI.

A subset of 40 patients from each study group (80 patients total) will undergo additional platelet reactivity testing with the vasodilator stimulated phosphoprotein (VASP) assay.All patients will be followed throughout the duration of the hospital stay.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age 18 or older, of both genders
2. Presenting with an ACS, defined as at least two of the following:

   Symptoms consistent with myocardial ischemia; ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG; Cardiac troponin I level above the upper limit of normal.
3. An initial invasive strategy (e.g. early angiography) is planned.
4. No contraindications to prasugrel therapy.

Exclusion Criteria:

1. Known allergies to aspirin, clopidogrel, or prasugrel.
2. Patient known to be pregnant or lactating.
3. Patient with known history of bleeding diathesis, or currently active bleeding.
4. Platelet count \<100,000/mm3 at the time of enrollment.
5. Hematocrit \<25% at the time of enrollment.
6. On warfarin therapy at the time of PCI, or patient likely to require warfarin therapy post-PCI.
7. Received fibrinolytics within the past 48 hours.
8. Received a glycoprotein IIb/IIIa inhibitor within the past 48 hours, or if a strategy for PCI involving a glycoprotein IIb/IIIa inhibitor is planned.
9. Taking maintenance thienopyridine therapy in the previous 7 days.
10. Known blood transfusion within the preceding 10 days.
11. Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
12. Patients with known chronic liver disease.
13. Age greater than 75 years.
14. Body weight less than 60 kg.
15. History of stroke or transient ischemic attack.
16. Surgery planned within 1 month.
17. Patient likely to require coronary artery bypass grafting.
18. Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.
Retention Rate and Caries Preventive Effect of Preheated Flowable Resin Composite Used as a Pit and Fissure Sealant

Retention rate and caries preventive effect of preheated flowable resin composite used as a pit and fissure sealant versus conventional resin-based fissure sealant in patients with permanent molars with deep pit and fissure over one year follow up. A randomized clinical trial

Statement of the problem:

Pit and fissure sealant placement is considered as an effective modality for prevention of caries on occlusal surfaces. Penetration, retention and lateral wall adaptation are the key factors in success of pit and fissure sealant restorations .

The retention is very critical for the sealing material and the successful penetration of the material into the pits and fissures However, the morphology of the fissures significantly influences the penetration of the sealing material occlusal fissure pattern like in deep and narrow fissures like I-type and IK- type where lesser penetration may be encountered fillers are added to the pit and fissure sealants in order to increase their wear and abrasion resistance. However, these fillers could lead to increase in the viscosity with subsequent decrease in the penetration.

Rationale:

According to a systematic review, they found that preheating of resin composite apparently increases the flowability of regular consistency composites, which improves the adaptation of the material into the cavity walls. Also studied the effect of heat and sonic vibration on penetration of flowable resin composite, they found that higher penetration was associated with heat compared with the conventional application method. So, this proposal is introduced with the hypothesis that preheating of filled fissure sealants may enhance their flowability and penetration especially into those fissures with complex structure.

Eligibility Criteria:
Inclusion Criteria:

participant:

1. Young adults (16_22y)
2. Patients who have existing pits and fissures that are anatomically deep and caries susceptible.

Teeth

1. Permanent molars teeth without any caries and cavitation. (Azarpazhooh \& Main 2008)
2. Permanent molar teeth that have deep pit and fissure morphology, with "sticky" fissures.
3. Permanent molar teeth with stained grooves.
4. Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2).

   -

Exclusion Criteria:

participant:

1. Uncooperative behavior, limits the use of sealants due to hampering of adequate field or isolation techniques throughout the procedure.
2. Patients allergic to sealant material.
3. Patient with history of medical disease, drug therapies or any other serious relevant problem.

Teeth:

1. An individual with no previous caries experience and well coalesced pits and fissures
2. Partially erupted teeth.
3. Teeth with cavitation or caries of the dentin.
4. A large restoration is present on occlusal surface.
5. If pits and fissures are self-cleansable.
6. Teeth with dental fluorosis, hypocalcification or hypercalcification
Bone Metastases in neurOendocrine NEoplasms: naTural History, Prognostic Impact and Therapeutic Approach (MONET)

This is a retrospective/prospective observational multicentric trial on patients with bone metastases from NENs.

General objectives:

* To trace on a national scale the frequency of bone metastases in patients with neuroendocrine neoplasm (NEN) and their clinical management.
* To correlate clinical and biological factors to clinical outcomes.
* To centralise and to make homogeneous clinical, pathological, instrumental and therapeutic information.
* To set up a database and to acquire biological material for studying predictive and prognostic biomarkers.

Background, rationale and objectives:

On March 25th 2015 the Ethical Committee from IEO approved the academic study entitled "Bone metastases in neuroendocrine tumors (NETs): a survey on natural history, prognostic value and treatment approach", version 1.0 30-Jan-2015. This was a retrospective study led to report how the issue bone metastases from NETs was handle in real practice. Preliminary data related to 321 patients from 18 Italian centers were presented as a poster at the ESMO 2017 congress (Fazio et al. 448P) and they will be included in a manuscript to submit for publication in a peer-review journal. The current protocol regards the continuation of the retrospective analysis, starting since 2014, since the previous study required data collection up to 2013, and at the same time a multicenter prospective observational analysis on the topic.

Duration of the study The study will regard patients fulfilling the eligibility criteria from 2014 to 2021. Data analysis will be completed by the year 2021.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of NEN
* Instrumental and/or histological diagnosis of bone metastasis
* At least one year of follow-up from the diagnosis of bone metastasis

Exclusion Criteria:

* Small cell lung carcinoma
* MiNEN
* Non neuroendocrine neoplasm
Melodic-based Communication Therapy for Promoting Spoken Language Development in Individuals With Nonverbal Autism

The purpose of this study is to determine the efficacy of Melodic Based Communication Therapy (M.B.C.T.) for increasing oral expressive skills in nonverbal children with autism spectrum disorders. MBCT has previously been shown to facilitate an improvement in expressive vocabulary, verbal imitative abilities, number of vocalizations, and social language development in nonverbal children with autism ages 5-7. However, earlier studies were small and did not examine the effects of M.B.C.T. on a younger and older population. This study will examine its effectiveness across a broader sample group. Additionally, this study will examine further predictors of success including but not limited to chronological age, developmental age, the frequency of repetitive/stereotypic behaviors, receptive language score, and social language score.

The study will be a repeated measures design as assessments will be taken at baseline and on a weekly basis (baseline, weeks 1-4). All participants in the study will receive Melodic Based Communication Therapy (M.B.C.T.). General procedures involved in (M.B.C.T.) are as follows: 25 common first words are selected as the targets (e.g., apple, ball, car, dog, cat, eat, go, etc.). Pictures and objects will be used as stimulus items. The top 3-5 incentives as identified by parent survey will be given according to the therapies specific reinforcement schedule. All treatment and evaluation sessions will be videotaped for future/further analysis and verification purposes. For the purposes of the study design, the same 25 words will be used for all participants.

4. Subjects will be male and female children diagnosed with autism.

5. Subjects will be between 3 years 0 months and 10 years 11 months of age.

6. In total, subject participation will last approximately 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male and female children with autism ages 3-years-0-months to 10-years-11-month who meet the criterion for nonverbal (defined as less than 10 words ever spoken expressively and no functional verbal communication)

Exclusion Criteria:

* Individuals receiving other language or articulation treatments or therapy at the time of the study, unable to regularly attend four 30 min sessions of therapy weekly for 4 weeks, a history of severe hearing impairment, severe visual impairment/ blindness, a diagnosis of an organic impairment of oral or laryngeal structures, or a signiﬁcant medical illness or condition which would prevent the child's participation in the treatment procedures. These conditions include, but are not limited to cerebral palsy, paraplegia, spina biﬁda, uncontrolled seizures, dysarthria, and amputation of arm(s).
EMR Versus ESD for Barrett's Neoplasia

Rationale:

The optimal technique for removal of visible dysplastic lesions in Barrett's esophagus remains controversial. Endoscopic mucosal resection (EMR) is safe, effective, easy to apply, and has been the most widely used technique since 2008. Endoscopic submucosal dissection (ESD) is a more controlled dissection method with potential improved efficacy, but at the cost of higher technical complexity.

Objective:

The investigators aim to compare EMR and ESD for removal of visible lesions in Barrett's esophagus.

Study design:

Randomized clinical trial

Study population:

Patients with Barrett's esophagus and a visible lesion with dysplasia and/or early cancer. Suspicion for submucosal invasion is an exclusion criterion.

Intervention:

Patients are randomized to receive either EMR or ESD, with follow-up and no ablation during 12 months after the resection.

Main study endpoint:

Primary endpoint is the proportion of patients with no evidence of residual or local recurrent neoplasia during 12 months follow-up after baseline.


Eligibility Criteria:
Inclusion Criteria:

* Patients age: ≥ 18 years
* Willingness to undergo both EMR or ESD
* Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation
* BE with a single visible lesion with absence of signs of submucosal invasion on endoscopy, after evaluation by the adjudication committee.

Exclusion Criteria:

* Patients with visible lesions with suspicion of submucosal invasion bases on assessment of the adjudication committee
* History of esophageal surgery other than fundoplication
* History of esophageal ablation therapy or endoscopic resection
* Multiple visible lesions in the BE segment at baseline
* Uncontrolled coagulopathy with INR \>2.0, thrombocytopenia with platelet counts \< 50,000
* Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment in-structions, or follow-up guidelines
* Life expectancy \<2 years
Apatinib in Refractory Colorectal Cancer

Limited agents have been approved after standard first and second line treatment. Regorafenib and Trifluridine/Tipiracil (TAS-102) are still not approved in China.Apatinib has shown significant efficacy in refractory advanced gastric cancer regarding PFS and OS with controllable toxicity.This study is aimed to explore the efficacy,safety as well as predictive biomarker in advanced colorectal cancer failed to standard therapy in Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
* Subjects with metastatic colorectal cancer(CRC) (Stage IV).
* Subjects must have failed at least two lines of prior treatment, which must include a fluoropyrimidine, oxaliplatin and irinotecan.
* Subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy.
* Subjects who have withdrawn from standard treatment due to unacceptable toxicity and precluding retreatment with the same agent prior to progression of disease will also be allowed.
* Prior treatment with bevacizumab and/or cetuximab will be allowed.
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.is necessary.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
* Life expectancy of at least 3 months.
* Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.
* assigned informed consent.

Exclusion Criteria:

* Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)\].
* Participants of other clinical trial within 4 weeks.
* Diseases which will impact the absorption of apatinib, eg. dysphagia, chronic diarrhea, bowl obstruction
* Hemorrhage events of ≥grade 3 within 4 weeks.
* known central nervous system metastasis.
* Uncontrolled hypertension. (Systolic blood pressure 140 mmHg or diastolic pressure 90 mmHg despite optimal medical management). Unstable angina,congestive heart failure,Myocardial infarction, Cardiac arrhythmias requiring anti-arrhythmic therapy.
* urine protein ≥++ and 24h urine protein more than 1.0g.
* Chronically green wound or bone fracture.
* Arterial or venous thrombotic or embolic events.
* Tumor invading important blood vessel with high risk of severe hemorrhage.
* Abnormal coagulation function.
* thromboemboli events within 6 months.
Prevalence of Inadvertent Hyperventilation During Intraoperative Anesthetic Care

This is a retrospective chart review of patients undergoing spinal fusion surgery to see the prevalence of hyperventilation.

Retrospective review of the operative schedules to identify patients who have undergone spinal fusion with placement of an arterial cannula for intermittent arterial blood gas analysis. The intraoperative records will be retrospectively reviewed. The following demographic data will be recorded: age, weight, gender, and co-morbid medical conditions. Ventilatory parameters at the time of ABG analysis will include (respiratory rate and tidal volume). ABG data will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent complex surgical procedures (spinal fusions) which necessitated arterial line placement and intermittent arterial blood gas analysis

Exclusion Criteria:

* None
12 Month Open Extension of TNS for ADHD.

Participants who exhibit sufficient ADHD symptom improvement in a prior study of active TNS will be invited to continue in a 12-month extension study, designed to collect additional data on long-term response and tolerability and to provide participants ongoing clinical benefit from treatment.

Children, ages 8-12 years, participated in a 5 week double-blind, sham-controlled study of active Trigeminal Nerve Stimulation (TNS). Participants randomized to sham in the double-blind, were then invited into a 4-week open TNS trial. Participants who met positive response criteria to active TNS, either during the original double-blind study or the open-treatment followup, were invited to continue their TNS treatment in a 12-month open extension phase.

Participants who continued in the 12-month extension returned for study visits every 3 months to assess ongoing response and safety/tolerability data. Unless otherwise noted, baseline line assessments in the 12-month extension are taken from the final visit of the preceding active treatment trial, i.e. the visit at which positive response criteria were met.

Eligibility Criteria:
Inclusion Criteria:

* male and female children ages 8-13 with DSM-5 ADHD, and current presentation, as determined by KSADS and clinical interview
* received active TNS therapy in a previous trial and demonstrated a CGI-I score \<= 2.
* parents able and willing to monitor proper use of the TNS device and complete all required rating scales
* parent and participants able to compete study rating scales and other measures in English

Exclusion Criteria:

* none