cyrilzakka/clinical-trials huggingface dataset:
Clinical Efficacy of Ceramic vs Resin Block Endocrown

Compare the comfort and durability of Ceramic (VITA,Suprinity ,VS) vs Resin Bloc (VOCO, Grandio Bloc,GB) Endocrown by chairside CAD/CAM system (computer aided design / manufacture).

Objective:To provide information of material selection for the chair-side restoration of the teeth after root canal treatment.

Pulpal and periapical diseases are the main causes of tooth loss. Root canal treatment (RCT) is the only effective way to treat these diseases. However, failure of RCT is commonly seen without coronal restoration.Endocrown is a new type of onlay with a retainer in the pulp cavity which consists of a cervical margin in the form of a butt joint and a preparation of the pulp chamber.This restoration method is not only good at the preservation of residual tooth tissue, but also suitable for severely damaged molars or premolars after dental pulp treatment.More and more endondontist tend to use this ways because they are a minimally invasive solution in such cases.Endocrown is mainly made of glass-ceramics, which has the advantages of beautiful appearance, high hardness and good biocompatibility. However, ceramic materials are brittle and fracturable, and need to be sintered twice in the manufacturing process, which is relatively complex and time-consuming. Composite resin block material is a new type of composite material developed in recent years. It is used for chairside CAD/CAM restoration,It has beautiful and natural color, and its elastic modulus is close to dentin. Therefore, it is more compatible with natural teeth in performance.Moreover, In the process of making, the steps of secondary sintering and glazing are omitted and shortened. But, there was no sufficient data to verify which material was more effective. The main aim of this trial is to compare the clinical efficacy of ceramic vs resin-based bloc endocrown. Other objectives include looking for the prognostic and influence factors of the related effects.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is healthy and is 18-75 years old and has molar teeth and tooth root apex without evident damage and no root fracture, as determined by x-ray.
2. The patient has three or four walls of intact tooth tissue after root canal treatment
3. The patient has good oral hygiene.
4. The patient has signed an informed consent form.
5. The patient is not participating in any other clinical trial.
6. The patient has received a class A assessment according to FDI criteria for marginal adaptation after restoration.

Exclusion Criteria:

1. Obvious destruction of the apical tissue or presence of large cysts or both
2. Severe periodontitis
3. Oral malignant tumor(s)
4. Undergoing radiotherapy
5. Pregnancy
6. Mental illness or systemic diseases
7. Incapable of self-care
8. Unsuitable for the trial as deemed by the researchers
Assessment of Hand-grip in the Prevention of Postural Orthostatic Hypotension

The study is aimed to assess the efficacy of hand-grip in preventing orthostatic hypotension in 20 patients diagnosed with autonomic failure. Five healthy subjects will be studied for comparison. The investigators will evaluate the subjects while on tilt table for 10 minutes and than while mounted from lying down to 70 degrees for additional 10 minutes. Blood pressure, heart rate and symptoms will be continuously measured. First study will evaluate the blood pressure changes. Second measure will include hand-grip maneuver 1 minute before the erect positon. Trans cranial Doppler will assess the intracranial blood flow during the position changes.

Study 1:

10 minutes lying on the tilt table. Performing TCD study at 10 minutes. Raising the tilt table to 70 degrees. Performing TCD study 5 minutes after tilting. Measuring blood pressure and symptoms for 10 minutes. Returning the tilt bed to supine position.

Study 2. in continue with study 1:

10 minutes lying on the tilt table. Performing TCD study at 10 minutes. Performing hand-grip at 50-70% grip force for 1 minute Raising the tilt table to 70 degrees. Performing TCD study 5 minutes after tilting. Measuring blood pressure and symptoms for 10 minutes. Returning the tilt bed to supine position.

Eligibility Criteria:
Inclusion Criteria:

* Man or women
* 18 years of age or older
* Diagnosed with orthostatic hypotension due to Parkinson's disease, multiple system atrophy or pure autonomic failure
* Orthostatic hypotension is not due to drugs, any heart disorder, anemia or dehydration

Exclusion Criteria:

* Pregnant or breast feeding
Caffeine Versus Placebo for Spinal Headaches

Caffeine will be studied against placebo in patients with positional headache after a lumbar puncture (aka "spinal headache").

Pain will be assessed at set intervals using a Visual Analog Scale. Blood patch therapy will be offered to all those still in pain at the end of one hour after drug administration.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with post dural puncture headache

Exclusion Criteria:

* age \< 18
* pregnant
* allergic to caffeine
* cardiac or peripheral vascular disease
* uncontrolled hypertension
Individual Patient Data Meta-analysis of CSII vs. MDI in Type 2 Diabetes

This study aims to compare glycaemic control during continuous subcutaneous insulin fusion (CSII, insulin pump therapy) and multiple daily insulin injections in type 2 diabetes and to identify patient-level characteristics that predict the best improvement in control and any change in insulin dose or other outcome.

The investigators will identify randomised controlled trials without language restriction that meet the inclusion criteria by searching the Cochrane database, Ovid Medline, Google Scholar and other sources. The investigators will exclude observational studies, short-term trials \<2 months duration, studies in pregnant diabetic subjects, newly diagnosed type 2 diabetes, trials in type 1 diabetes and extensions of previous studies.

Data on individual participants will be obtained directly from trialists and from funding sponsors who hold the trial data and will include age, sex, duration of diabetes, treatment group, baseline and final HbA1c, baseline and final insulin dose, baseline and final BMI.

A 'two-step' meta-analysis will be performed to estimate overall mean differences in HbA1c, insulin dose and weight/BMI for the trials. Then, a 'one-step' meta-regression analysis will be conducted by creating a single large dataset from the individual patient data. Determinants of final HbA1c, BMI/weight and insulin dose will be explored using Bayesian approaches with covariates that include baseline HbA1c, age, diabetes duration, BMI, insulin dose and interactions between the covariates.

Eligibility Criteria:
Inclusion Criteria:

* RCTs of CSII vs. MDI in type 2 diabetes, study duration at least 2 months, non-pregnant

Exclusion Criteria:

* Type 1 diabetes, studies \<2 months duration, pregnant women, newly diagnosed type 2 diabetes and extensions of previous studies.
Pilot Study of Pharmacology of Paracetamol Administered Per-oral Mucosa

Paracetamol is the centrally acting analgesic most commonly used in the world, indicated for the symptomatic treatment of fever and pain in mild to moderate. It comes in different formulations for oral, intravenous and rectal. The IV route allows rapid passage of paracetamol in the systemic arterial circulation and thus the brain, faster distribution evidenced a higher plasma concentration compared with oral and rectal. However the IV route also has disadvantages well known risks iatrogenic perfusion is an invasive lengthy, unpleasant and painful.

The way per-Albus not to date used for the administration of paracetamol. It is a path nonetheless very interesting for the rapid absorption of drugs such as nitrates used in angina pectoris, as it seeks a highly vascular area (the floor of the tongue or gingival groove) and allows a very rapid action. Furthermore, the terminal per-oral mucosa, less restrictive than IV administration and faster than oral administration, requires a simple medical gesture without special surveillance after administration, produces no pain or risk of infection for the patient (in contrast to the IV). It is interesting to test a new dosage form per-oral mucosa of paracetamol and compare pharmacological level (pharmacokinetics and pharmacodynamics) with the only dosage form of reference used by the IV route.

Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Aged over 18 years and not more than 50 years
* Males
* Values of vital signs before administration of the test products:

  * NOT between 100-140 mm Hg
  * PAD between 50-90 mm Hg
  * Radial pulse between 45-90 beats per minute
* Free from any treatment in the 7 days preceding inclusion including no use of analgesics or anti-inflammatories)

Exclusion Criteria:

* Contraindications to the administration of paracetamol
* Hypersensitivity to paracetamol
* History of hepatitis B or C
* Severe renal impairment
* Hepatic insufficiency
* Medical history and / or surgical judged by the investigator or his representative as being incompatible with the test, especially subjects with neuropathic pain
* Pathology evolutionary time of the review for inclusion
* Binge drinking, smoking (more than 10 cigarettes/day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day) or drug abuse
* Subject does not meet the selection criteria regarding their ability to discriminate the sensations resulting from noxious stimuli during psychometric testing
* Topic having all breaches of the oral mucosa (aphthae)
A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects

The principal aim of this study is to obtain safety and tolerability data when PXT002331 is administered orally as single and multiple doses to healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects will be; 1.1. males or females of non childbearing potential 1.2. For females, non childbearing potential is defined as follows:

   * permanently sterile following hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or confirmed tubal occlusion (not tubal ligation)
   * postmenopausal, defined as at least 1 year post cessation of menses (without an alternative medical cause) 1.3. of any ethnic origin 1.4. between 18 and 60 years of age, inclusive
2. Subjects will have a 2.1. body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2, inclusive 2.2. body weight between 50 kg and 100 kg, inclusive
3. Subjects will be in good health, as determined by; 3.1. medical history 3.2. physical examination 3.3. vital signs assessment 3.4. 12 lead ECG and 24 hour Holter Monitoring 3.5. clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is not acceptable)
4. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
The Bleeding With Antithrombotic Therapy Study 2

The purpose of this study is to determine the incidence and severity of bleeding complications in patients with cerebrovascular and cardiovascular diseases treated with oral antithrombotic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cerebrovascular or cardiovascular diseases who start or continue taking oral antithrombotics (antiplatelets and/or anticoagulants) to prevent vascular events
* Patients who are able to receive MRI
* Provision of written informed consent either directly or by a suitable surrogate

Exclusion Criteria:

* MRI contraindication
* Any condition that in the opinion of the responsible physician or investigator that renders the patient unsuitable for the study
Clinical Trial of Pentoxifylline in Patient With Cirrhosis

In patients with cirrhosis and liver failure, pro-inflammatory cytokines (TNF alpha) might be responsible of severe complications and death. Thus, the prevention of cytokine production should prevent complications and mortality.

The aim of this study is to study the 2 months survival rate in patients with severe cirrhosis (Child-Pugh C) with pentoxifylline - an inhibitor of cytokine production. The 6 month mortality, the proportion of transplanted patients, the occurrence of complications (bacterial infection, renal failure, hepatic encephalopathy and gastrointestinal bleeding), plasma cytokine levels and fibrotest - a marker of fibrosis - will be also studied. This is a multicenter double blind randomized trial with a placebo.

All adult patients with severe cirrhosis might be randomized after written consent. Patients with severe carcinoma, intolerance or contraindication to pentoxifylline will not be included. Patients receive either pentoxifylline or placebo 3 times a day for 6 months. Three hundred and forty two patients are necessary to decrease mortality rate by 50% at 2 months in a beta risk of 10% and an alpha risk of 5%. Patients will be seen every month.

The aim of this study is to study the 2 months survival rate in patients with severe cirrhosis (Child-Pugh C) with pentoxifylline - an inhibitor of cytokine production. The 6 month mortality, the proportion of transplanted patients, the occurrence of complications (bacterial infection, renal failure, hepatic encephalopathy and gastrointestinal bleeding), plasma cytokine levels and fibrotest - a marker of fibrosis - will be also studied. This is a multicenter double blind randomized trial with a placebo.

All adult patients with severe cirrhosis might be randomized after written consent. Patients with severe carcinoma, intolerance or contraindication to pentoxifylline will not be included. Patients receive either pentoxifylline or placebo 3 times a day for 6 months. Three hundred and forty two patients are necessary to decrease mortality rate by 50% at 2 months in a beta risk of 10% and an alpha risk of 5%. Patients will be seen every month.

Eligibility Criteria:
Inclusion Criteria:

* adult patient of more than 18 years
* child pugh C cirrhosis

Exclusion Criteria:

* pregnant woman
* Patient received anticoagulant
* Patient treated for arterial hypertension
* Patient with severe coronaropathy
* Patient with hyper sensibility of pentoxifylline
* Patient hospitalized for less 24 hours
* Patient admitted for a treatment of hepatocellular-carcinoma or COLLANGIO- carcinoma
* Patient with HIV
* Patient who has been transplanted
* Patient treated with immuno- suppressors
* Patient who has already received pentoxifylline for 3 months before inclusion
* Patient for whom the follow-up is considered impossible
Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Kidney Cancer Undergoing Surgery

This pilot clinical trial studies stereotactic body radiation therapy in treating patients with metastatic kidney cancer undergoing surgery. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PRIMARY OBJECTIVES:

I. Assess the impact of stereotactic body radiation therapy (SBRT) on the immune system in patients with metastatic renal cell carcinoma (RCC).

SECONDARY OBJECTIVES:

I. Assess changes in immune parameters prior to radiation, post radiation and post nephrectomy.

TERTIARY OBJECTIVES:

I. Assess surgical parameters for partial or radical nephrectomy post SBRT.

OUTLINE:

Patients undergo SBRT on day 1 and undergo partial or radical nephrectomy on day 29.

After completion of study treatment, patients are followed up at 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Have metastatic RCC with primary tumor in place
* Must be surgical candidates as deemed fit by surgeon
* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
* Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Radiation to primary tumor prior to enrollment in this study
* Pregnant or nursing female patients
* Unwilling or unable to follow protocol requirements
* Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive treatment
* Received an investigational agent within 30 days prior to enrollment
Collagen Treatment in Facial Nerve Palsy

To test the effectiveness of a collagen-based treatment for patients complaining of long standing facial nerve axonotmesis, who are following a proprioceptive neuromuscular facilitation protocol (Kabat method), compared to a group only undergoing the Kabat method.

Objective: To test the effectiveness of a collagen-based treatment for patients complaining of long standing facial nerve axonotmesis, who are following a proprioceptive neuromuscular facilitation protocol (Kabat method), compared to a group only undergoing the Kabat method.

Methods: Patients undergoing both procedures will be compared, after randomization, to matched patients undergoing only Kabat procedure after 8 weeks of treatment. The outcomes will be electromyographic findings, validated questionnaires (Facial Disability Index, FDI) and clinical grading (House-Brackmann, HB). A correlation analysis will be performed between pre-/post-treatment diﬀerences (Δ) in outcome and clinical-demographic measures.

Eligibility Criteria:
Inclusion Criteria:

* patients with a medical diagnosis of long-term unilateral peripheral axonotmesis of the facial nerve

Exclusion Criteria:

* patients with facial palsy caused by central nerve disease;
* patients with a history of recurrent facial palsy;
* patients with a facial skin disease hampering the possibility of injecting the drug; - patients with difficulty in moving their face due to previous plastic surgery or facial surgery;
* patients with systemic diseases that can affect facial electromyography;
* patients deemed inappropriate by the researchers.
* patients with a history of hypersensitivity to any collagen solution constituent or showing pregnancy, lactation, neuromuscular junction disorders (myastenia gravis), peripheral motor neuropathies, or active infections will be also excluded.
Comparison of the Safety of Flublok® Versus Licensed IIV in Healthy, Medically Stable Adults ≥ 50 Years of Age

The hypothesis for this trial is that the incidence of a pre-defined composite of common systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that reported for licensed IIV recipients. Another hypothesis is that the safety and reactogenicity of Flublok is clinically acceptable, i.e. consistent with the overall safety profiles previously observed with Flublok and with the licensed comparator.

The Advisory Committee on Immunization Practices (ACIP) recommends that all people aged 6 months and older be immunized to prevent influenza. Currently the only approved influenza vaccine across the entire age group is inactivated influenza vaccine (IIV). A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Additional safety and, ultimately efficacy, data is needed to support use in adults ≥50 years of age, an important age group as adults ≥65 years of age are among those at increased risk of influenza complications.

Eligibility Criteria:
Inclusion Criteria:

1. Ambulatory adults aged 50 years and older
2. Medically stable, as determined by medical history and targeted physical examination based on medical history, if appropriate
3. Able to understand and comply with planned study procedures
4. Provides written informed consent prior to initiation of any study procedure.

Exclusion Criteria:

1. Known contraindication to either study vaccine (see product package inserts)
2. Receipt of any other influenza or other vaccine within 30 days prior to enrollment in this study.
3. Receipt of any new medication within 30 days prior to enrollment in this study
4. Plans to participate in any investigation involving an investigational product during this study.
5. Pre-existence of atopic dermatitis or any other cutaneous disorder that could complicate the evaluation of potential primary endpoints.
6. Any clinical or social circumstance that in the opinion of the investigator could interfere with compliance with study procedures or interfere with the interpretation of clinical data.
DNA Methylation for Screening Uterine Cervical Lesions

The primary objective of this study is to compare the testing of DNA methylation, high-risk HPV subtypes, and cytology with the definite histological results for uterine cervical lesions in a prospective cohort study.

This study will include 300 unselected patients with definite histological results. All the cervical specimens of cytology collected in the clinical settings will be utilized for the testing of DNA methylation, high-risk HPV subtypes and thin prep liquid-based cytology test (TCT). The sensitivity, specificity, positive predictive value and negative predictive value were calculated based on the known histological results. The differences of DNA methylation with high-risk human papillomavirus (HPV) and TCT will also be analyzed.

The testing of DNA methylation will be performed with the methylation-specific polymerase chain reaction (PCR). The TCT and HPV testing will be performed with the Roche kits.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed cervical histology within one month when collecting cervical cytology
* Aged 18 years or older
* Signed an approved informed consents

Exclusion Criteria:

* Not meeting all of the inclusion criteria