cyrilzakka/clinical-trials huggingface dataset:
The Effect of Solvent Usage on Post-treatment Pain

No clinical evidence has been yet published regarding the comparison of postoperative pain after removal of the root canal fillings with or without solvent. The aim of this study was to evaluate the effect of combined usage of ProTaper retreatment instruments and a gutta-percha solvent, on the postoperative pain intensity after retreatment.

Scientific literature contains a few studies regarding the amount of apically extruded debris caused by solvent or solvent free use of rotary instruments. It was reported that the use of ProTaper retreatment instruments in combination with gutta-percha solvent reduced the amount of apically extruded debris compared to their solvent free use. Nevertheless,no clinical evidence has been yet published regarding the comparison of postoperative pain after removal of the root canal fillings with or without solvent. The aim of this study was to evaluate the effect of combined usage of ProTaper retreatment instruments and gutta-percha solvent, on the postoperative pain intensity after retreatment. The adult patients (18-59 ages) who referred to Department of Endodontics with a diagnose of failed root canal treatment were examined radiographically and clinically. Endodontically treated, clinically asymptomatic, single-rooted teeth with one canal exhibiting chronic periapical infection were included. A hundred cases who matched the determined criteria were selected and randomly allocated to two groups:

Non-solvent Group (n=50):

ProTaper retreatment instruments were used in combination with with X-Smart electric motor for the removal of root canal fillings.

Solvent Group (n=50):

ProTaper retreatment instruments were used with the abovementioned technique but in combination with a gutta-percha solvent

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patient who has a failed root canal treatment.
* Asymptomatic single rooted teeth that had an initial root canal filling diagnosed with chronic apical periodontitis.
* Patients agreed to parcitipate in the study

Exclusion Criteria:

* Overfilled teeth,
* teeth with intraradicular posts,
* existence of a sinus tract,
* consumption of antibiotics or analgesics within one month,
* pregnancy,
* history of trauma,
* traumatic occlusion
Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects

The aim of this study is to investigate the safety, pharmacokinetics, pharmacodynamics of intranasal dexmedetomidine, and comparative pharmacokinetics of intranasally and intravenously administered dexmedetomidine in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male 18 - 40 years of age
* Body weight \>/= 50 kg (male) or \>/= 45 kg (female), with BMI between 19.0 and 26.0 kg/m2, inclusive
* Capable of giving written informed consent

Exclusion Criteria:

* Clinically significant disease or conditions that may place the subject at unacceptable risk as a participant in the study, or that may interfere with the safety, tolerability or pharmacodynamic evaluations in the study
* Laboratory tests positive for HIV, Hepatitis B virus surface antigen, or Hepatitis C virus antibody; positive drug or alcohol test
* Major surgery within 4 weeks of screening
Oral Bioavailability of Curcumin From Micronized Powder and Liquid Micelles in Healthy Young Women and Men

Background: The oral bioavailability of curcumin is low due to its limited intestinal uptake, rapid metabolism and excretion from the body. Considering its potent reported health-beneficial properties, researchers have tried to increase its bioavailability as a means to enhance its biological activities.

Objective: The aim of the project was to develop novel curcumin formulations with enhanced oral bioavailability and to study the safety of the formulations and potential sex-differences in humans.

Design: In this single-blind crossover study with three arms separated by ≥1-week washout periods, healthy subjects (13 women, 10 men) were provided standardized meals and took, in random order, a single oral dose of 500 mg curcumin as native powder, micronized powder, or liquid micelles. Blood and urine samples were collected in intervals for 24 h and total curcumin, demethoxycurcumin, and bis-demethoxycurcumin were quantified.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers with routine blood chemistry values within the normal ranges

Exclusion Criteria:

* overweight (BMI \>30 kg/m2)
* metabolic and endocrine diseases
* pregnancy
* lactation
* drug abuse
* use of dietary supplements or any form of medication (with the exception of oral contraceptives)
* smoking
* frequent alcohol consumption (\>20 g ethanol/d)
* adherence to a restrictive dietary regimen
* physical activity of more than 5 h/wk
* participation in a clinical trial within the past 3 months prior to recruitment
* known intolerance against curcuma
HBV-Specific TCR-T Cell Therapy Combined with Nucleos(t)ide Analogues in Chronic Hepatitis B Patients

This is a open-label study to evaluate the safety and efficacy of autologous T-cells transfected with messenger ribonucleic acid (mRNA) encoding Hepatitis-B virus (HBV) antigen specific T cell receptor (TCR) in combination with nucleos(t)ide analogues (NAs) in HBeAg-positive chronic hepatitis B patients.


Eligibility Criteria:
Inclusion Criteria:

* CHB infection (Serum HBsAg-positive for ≥ 6 months)
* Serum HBeAg-positive
* HLA class 1 profile matching HLA-class I restriction element of the available T cell receptors (restricted by either HLA-A\*02:01, A\*11:01 or A\*24:02).
* Liver biopsy, Fibroscan or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis (≥Metavir 3).

Exclusion Criteria:

* History or other evidence of chronic liver disease unrelated to HBV infection (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, thalassemia, non-alcoholic fatty liver disease)
* Decompensated liver function, such as Child-Pugh grade B or C, or clinical signs of decompensated liver function like ascites and varices
* Positive HIV test result
* History or suspected diagnosis of hepatocellular carcinoma, or AFP at screening \> 20 ng/mL (if AFP \> 20 ng/mL, a liver scan result is required to exclude hepatocellular carcinoma)
Combined Effects of Aerobic Exercise and Cognitive Training on Cognition After Stroke

The objective of the 'Exploring potential synergistic effects of aerobic exercise and cognitive training on cognition after stroke' pilot trial is to investigate the combined effects of aerobic and cognitive training on cognition after stroke. This is to lay the groundwork for a larger RCT on the same topic. Twenty patients greater than 6 months post-stroke will be randomly assigned into one of four following treatment groups: (i) aerobic training (AEROBIC group), (ii) cognitive training (COGNITIVE group), (iii) aerobic exercise plus cognitive training (AEROBIC+COGNITIVE group); and (iv) non-aerobic range of motion (ROM) and unstructured mental activity (CONTROL group) (for group descriptions, please see detailed description below). We hypothesize that the combination of aerobic exercise and cognitive training will be more effective in improving cognition after stroke than either treatment on its own.

Aerobic exercise: Body weight support (BWS) treadmill exercise at moderately high intensity (60-70% of heart rate reserve) using 15-30% BWS. An additional 6-10 min will be needed for warm-up and cool-down. Heart rate will be continuously monitored, and blood pressure and rating of perceived exertion (RPE) will be measured periodically.

Cognitive training: Computerized dual n-back training program that involves a working memory task, the difficulty of which adapts to the individual participant's performance.

ROM exercise: Non-aerobic passive and active movement of upper and lower extremity joints performed with the subject lying on a plinth. RPE will be recorded every 5 minutes to ensure intensity remains low. Mental activities: Unstructured mental activity: such as listening to light novels on tape, which will be selected by the subject from a pre-determined list.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Diagnosis of ischemic or hemorrhagic stroke \>6months ago
* Be able to perform a two-step command
* Be able to walk ≥10m with/without aid
* Live within a 75km radius of the QE II
* Pass a cardiology screen for safe participants in exercise training

Exclusion Criteria:

* Have moderate or severe receptive aphasia
* Have terminal illness, life-threatening co-morbidity or concomitant neurological or psychiatric illness
Regional Anesthesia for Thoracoscopic Surgery

Aim of the study is to evaluate different regional anesthesia regimes for thoracoscopic surgery to evaluate their efficiency in (postoperative) pain control.

Three regional anesthesia forms are evaluated: thoracic epidural anesthesia, (ultrasound-guided) serratus-anterior-plane-block an local infiltration with local anesthetic at the site of performing the thoracoscopy.

A prospective evaluation of different regional anesthesia regimes for thoracoscopic surgery to elucidate their efficiency in (postoperative) pain control.

A day before surgery the patients gave their written informed consent to the study.

Patients choose their favorite regional anesthesia out of the following: thoracic epidural anesthesia, (ultrasound-guided) serratus-anterior-plane-block an local infiltration with local anesthetic at the site of performing the thoracoscopy.

In addition a general anesthesia was applied for the surgical procedure. Anesthesia was maintained using propofol and remifentanil. The patients pain score (visual analog scale), consumption of analgesic medication, satisfaction with pain therapy will be obtained one, six, 24 and 48 hours postoperatively.

These prospective evaluation of different regional anesthetic techniques might provide us data to recommend a procedure for thoracoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for thoracoscopic surgery
* ASA 1-3

Exclusion Criteria:

* ASA 4 and 5
* Age under 18 and over 80
Evaluation of an Hydrophilic Acrylic Intraocular Lens

Evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens

To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) at 12-24 month postoperative.

Eligibility Criteria:
Inclusion Criteria:

* Patients of any gender, aged 18 years or older at the time of the surgery
* Patients who had an uncomplicated (no intra-operative complication) aged-related cataract surgery
* Currently implanted with the study IOL into the capsular bag in at least one eye
* One-year post surgery follow-up (365 days -14 days/+365 days) for the study eye at the time of the postoperative visit
* Patient is willing and capable of providing informed consent
* Patient is willing and capable of complying with visits and procedures as defined by this protocol

Exclusion Criteria:

* Preoperative corrected distance visual acuity (CDVA) better than 0.3 LogMAR (0.5 decimal) or CDVA not available preoperatively
* Preoperative documented endothelial cell count of less than 2000/mm2 (if available)
* Any preoperative documented ocular disorder that could potentially cause a clinically significant future visual acuity loss
* Any preoperative documented clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
* Any preoperative documented clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
* Any preoperative documented clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
* Any preoperative documented history of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis
* Any preoperative acute infection (acute ocular disease, external/internal infection, systemic infection)
* Any previous preoperative intraocular and corneal surgery
* Preoperative documented uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
* Preoperative documented or current systemic or ocular pharmacotherapy that effects patients' vision
* Any other preoperative documented or current pathology or condition that could be a risk for the patient according to the investigator opinion
* Women during pregnancy and/or lactation at time of enrollment into the study
* Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
* Patients whose freedom is impaired by administrative or legal order
* Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, that do not affect patients' vision
Ketones & Mitochondrial Heteroplasmy

The current study is a prospective evaluation of the ability of ketosis to shift mitochondrial DNA (mtDNA) heteroplasmy in subjects harboring a known mutation in their mtDNA at position 3243 (A\>G). Subjects will be given supplemental medium chain triglycerides (MCTs) for a period of 6 months. mtDNA heteroplasmy will be measured 3 months prior to treatment, at treatment initiation, and 6 months after initiation.

The primary objective of the current study is to determine if there is a shift in heteroplasmy in patients harboring the 3243 A\>G mtDNA mutation to a more favorable (higher wild-type) profile while in a state of ketosis.

The current study is a prospective evaluation of the ability of ketosis to shift mitochondrial DNA (mtDNA) heteroplasmy in subjects harboring a known pathogenic mutation in their mtDNA at position 3243 (A\>G). Subjects will be induced in to ketosis by administration of supplemental medium chain triglycerides (MCTs) for a period of 6 months. mtDNA heteroplasmy will be assessed 3 months prior to treatment, at treatment initiation, and 6 months after initiation.

The primary objective of the current study is to determine if there is a shift in heteroplasmy in patients harboring the 3243 A\>G mtDNA mutation to a more favorable (higher wild-type) genotypic profile while in a state of ketosis.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is informed and given ample opportunity to consider his/her participation and has given his/her written consent.
2. Subject is willing and able to comply with all trial requirements.
3. Subject harbors the 3243 A\>G mtDNA mutation at a level detectable in blood.
4. Female subjects of child-bearing potential must not be pregnant. Female subjects of child-bearing potential (not surgically sterile or 2 years post-menopausal) must also agree to use appropriate contraceptive methods (abstinence, oral, injectable, implantable, or barrier) for the duration of the trial.
5. Subject must not have diabetes mellitus.

Exclusion Criteria:

1. Subject is currently participating or has participated within the last 2 months in any clinical trial involving treatment of mitochondrial disorders with MCT supplementation or induction of ketosis.
2. Subject has a medical condition that could reasonably be exacerbated by ketone supplementation (including diabetes mellitus).
3. Subject is unable to give reasonable informed consent/assent.
4. Subject is a pregnant or nursing female.
Fatty Liver and Ectopic Fat in Overweight and Obese Patients

The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.

Non invasive assessment of liver fibrosis and liver inflammation and steatosis is clinically relevant in patients exposed to non alcoholic fatty liver diseases.

The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.

Fatty liver and ectopic fat accumulation will be particularly assessed.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 40
* ALAT level superior to normal level even after 3 months of diet
* alcohol consumption \< 20 g/j for women and \< 30 g/j for men

Exclusion Criteria:

* HIV, hepatitis B virus, hepatitis C virus positive
* known hemochromatosis
* glycemia \> 1.26 g/L or under anti-diabetic treatment
Assessment of Pain in Plantar Fasciitis Managed by Histotripsy

Plantar fasciitis or plantar fasciitis is the most commonly reported cause of pain under the heel. Its prevalence varies from 3.6 to 7% in the general population. It is a painful condition of the foot that corresponds to an inflammation of the plantar fascia.

At present, histotripsy in the field of orthopedics is very little used. The concept of therapeutic ultrasound intended for the treatment of plantar fasciitis by fascial section was developed in the United States but no study evaluating its effects on pain is available.

There is no equivalent study on histotripsy in the pathology of chronic plantar fasciitis or fasciitis. In this study, histotripsy will be performed using a conventional serial ultrasound system with this focused energy function.

The research hypothesis is that histotripsy treatment may be an alternative to pain management in patients with plantar fasciitis who have failed conventional treatments.

The main objective of this study is to evaluate the evolution of the pain felt by patients with plantar fasciitis resistant to conventional medical treatment, one month after two ultrasound histotripsy sessions.


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, aged 18 years minimum
* Patient with plantar fasciitis evolving for at least 6 months
* Patients with radiology and MRI of the foot less than 3 months old
* Visual analogue pain scale greater than 5 at inclusion
* Patient in whom conventional medical treatment has failed by the combination of radial shock waves, plantar orthoses, and corticosteroid infiltration that has not provided relief.
* Patient affiliated with or beneficiary of a social security scheme.
* Patient who has been informed and has given his/her free, informed and written consent.

Exclusion Criteria:

* Minor patient
* Major retraction of the triceps surae on the MAESTRO oblique board test: sequelae of bone trauma to the hindfoot and ankle.
* Inflammatory rheumatological diseases
* Fibromyalgia
* Patients in whom a specific underlying organic pathology (inflammatory, infectious, neoplastic, etc.) has been identified.
* Psychiatric disorders
* Patient participating in another research study.
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman.
* Patient hospitalized without consent.
Osteoarthritis Structural Changes Assessed by Magnetic Resonance Imaging and Neuropathic Pain in Knee Osteoarthritis

The primary objective of this study is to identify osteoarthritis (OA) structural changes, as assessed by MRI, that best correlate with the presence of neuropathic pain (NP) using the PainDETECT questionnaire (PainDETECT ≥ 13) on a population of patients with OA of the knee experiencing moderate to severe pain (VAS ≥ 40 mm).

This study is a multicentre, cross-sectional observational pilot study. The presence of NP was determined based on use of the PainDETECT questionnaire (score 1 to 38), the score of which was defined for the purpose of the study as ≥ 13. A total of 50 OA patients with moderate to severe pain (VAS ≥ 40), 25 without the presence of NP (OA/NP-) (PainDETECT score \< 13), and 25 with the presence of NP (OA/NP+) (PainDETECT score ≥ 13) were enrolled. Since this is a pilot study, we arbitrarily determined the number of patients at 50, which represents 25 patients per arm, a number deemed sufficient to identify the knee OA structural changes that could be preferentially associated with NP.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of either sex, aged 40 years and more;
* Followed in an ambulatory clinic;
* Presenting with primary OA of the knee according to American College of Rheumatology (ACR) criteria;
* With an OA of radiological stages 2 and 3 according to Kellgren-Lawrence;
* Knee pain for at least 1 month out of the 3 months preceding the study;
* Visual Analog Scale (VAS) of pain while walking on a flat surface ≥ 40 mm;
* Agrees to sign the Informed Consent Form;
* Not taking part in another clinical trial;
* Agrees to respect the protocol.

Exclusion Criteria:

* Other bone and articular diseases (antecedents and/or current signs);
* Presenting with isolated knee lateral compartment OA defined by joint space loss in the lateral compartment only;
* Knee surgery on the study knee;
* Comorbidities that restrict knee function;
* Had received any investigational drug within 30 days or 5 half lives (whichever is greater) prior to entering the study;
* Unable to give informed consent;
* Counter-indication to an MRI examination;
* Baseline Visit cartilage volume cannot be calculated from the MRI due to advanced OA or any other technical reason;
* Abnormal findings and or any other condition, which, in the Investigator's judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data through MRI to achieve the objectives of the study.
Safety, Tolerability, PK and PD of LGT209 in Healthy Volunteers and Patients With Hypercholesterolemia

This study is designed to measure the effects of LGT209 when given intravenously to patients with high cholesterol who are on stable doses of statin medications, and to healthy subjects with elevated cholesterol


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers: Male and female subjects 18 to 70 years of age, in general good health but with high cholesterol
* Statin patients: Male and female patients 18 to 70 years of age, with high cholesterol on stable statin therapy for at least 3 months

Exclusion Criteria:

* Healthy volunteers: History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
* Women of child-bearing potential unless using highly effective methods of contraception
* Statin patients: Use of any prescription drugs for lipid lowering other than HMG CO-A reductase inhibitors (statins); use of two concurrent antihypertensive medications is allowed, provided stable dosing has been achieved for the prior 3 months
* Women of child-bearing potential unless using highly effective methods of contraception

Other protocol-defined inclusion/exclusion criteria may apply