cyrilzakka/clinical-trials huggingface dataset:
Can the Different Instruments Used ın Root Canal Treatment Have an Effect on Postoperative Pain?

Root canal treatment is a treatment method in which the pulp is irreversibly infected due to caries or trauma or when the pulp loses its vitality. Biomechanical preparation of primary teeth is an important step for a successful root canal treatment. The success of root canal treatment depends not only on the biological results of the treatment, but also on minimizing the postoperative pain of the patients. Therefore, the elimination of factors associated with postoperative pain has an important role in the prognosis of patients after treatment. In all root canal preparation methods, some debris overflows from the apical. Debris protruding into the apical area causes postoperative pain. Many studies in the literature have shown that NiTi rotary files cause less extrusion of debris compared to hand files, and therefore less postoperative pain. Within the scope of this study, the effect of NiTi K hand file and WaveOne Gold, ProTaper Next, EndoArt NiTi Pedo Gold file, AF Baby rotary file systems on postoperative pain in root canal treatment preparations applied to the mandibular primary molar teeth of pediatric patients aged 5-8 years. It is intended to be evaluated using VAS).

In our research; ProTaper Next (PTN), WaveOne Gold (WOG), AF Baby rotary file, EndoArt NiTi Pedo Gold file, NiTi K type hand files were used. 100 patients between the ages of 5 and 8 who had root canal treatment indications for mandibular primary second molars were included in the study. The patients were divided into 5 groups with 20 patients in each group. All systems were used according to the manufacturer's instructions and all treatments were performed by a single operator in a single session. Postoperative pain was recorded using the Visual Analog Scale (VAS) at the 6th, 12th, 18th, 24th, 48th, 72nd hour and 1st week following treatment. The obtained data were evaluated statistically.


Eligibility Criteria:
Inclusion Criteria:

* No analgesic use 12 hours before root canal treatment
* No systemic disease.
* Teeth with a diagnosis of irreversible pulpitis, no other teeth causing pain at the site of the tooth to be treated, no inter-root bone loss exceeding 1/3, and root canal inclinations of no more than 25° according to Schneider method were included in the study.

Exclusion Criteria:

* Patients with post-procedural analgesic use were excluded from the study
* Patients whose parents did not fully understand the instructions and who did not attend the follow-up visit one week after treatment were excluded.
Omega-3 Fatty Acids and Chemotherapy-induced Neuropathy and Inflammation in Breast Cancer

The aim of this study is to assess the effects of n-3 fatty acids on taxane-induced neuropathy and neurotoxic inflammatory agents in patients suffering from invasive breast cancer.

Breast cancer is the most common malignancy in women. Chemotherapy with taxanes in patients with breast cancer causes some complications and neuropathy is one of the most frequent that is dose limiting and even may cause to stop the therapy. n-3 fatty acids have very significant role in improvement the function of the neurons.n-3 fatty acids decrease the demyelination and toxicities resulting from taxanes. They also lower the level of of the neurotoxic inflammatory agents. So,n-3 fatty acids improve the quality of life in this patients. 52 patients with invasive breast cancer will be randomized in a double-blind placebo-controlled manner to receive either 640 mg oil fish pearls( 54% DHA, 10% EPA) 3 times a day or placebo( corn oil pearls) for 3 months(during the chemotherapy with taxanes). Neuropathy (using EMG-NCV test)and the level of IL-1,IL-6, TNF-alpha, hs-crp and serum level of EPA and DHA fatty acids will be measured before chemotherapy with taxanes and at the end of the therapy (after 3 months).

Eligibility Criteria:
Inclusion Criteria:

* Suffering from invasive breast cancer,not receiving any form of supplementations and oil fish

Exclusion Criteria:

* Suffering from the diseases leading to neuropathy, e.g.diabetes, hyperthyroidism, AIDS and primary neural diseases
* Suffering from any other kind of malignancies
* Receiving any chemotherapeutical agents in the past
TEZSPIRE (Tezepelumab) Asthma Japan Post-Marketing Study (PMS)

The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire.

1. Development of related AEs
2. Contributing factors possibly having an impact on the safety and effectiveness
3. Development of unexpected related AEs

The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire.

1. Development of related AEs
2. Contributing factors possibly having an impact on the safety and effectiveness
3. Development of unexpected related AEs

This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Act on Securing Quality, Effectiveness and Safety of Products Including Pharmaceuticals and Medical Devices.

Eligibility Criteria:
Inclusion Criteria:

* The evaluable patients are those treated with Tezspire for the first time due to "Bronchial asthma (only the patients with severe or intractable bronchial asthma which could not be controlled with the existing therapy)

Exclusion Criteria:

None
Video-Based Task Oriented Activity Training in Patients With Juvenile Idiopathic Arthritis

Juvenile idiopathic arthritis (JIA) is most common chronic rheumatic disease in childhood. The upper extremity involvement in JIA causes muscle imbalance, joint destruction, pain, stiffness and limitations on daily living activities (DLA) in varying degrees. However, the information about prevalence of symptoms, disorders, DLA limitations, participation restriction and options of treatments for upper extremity involvement in JIA are limited. It has been reported that improvements of upper extremity functions were achieved by video-based games (VBG) in various disease groups. However, in the literature, no study has been found about effectiveness of WBG in children with arthritis. The aim of the study was to investigate effects of task-oriented activity training (TOAT) with VBG versus activity training in real life on activity performance and participation in children with arthritis. Participants with upper limb involvement in JIA were randomly assigned to the activity training in real life group (group I) and TOAT with VBG in real life group (group II). The actual materials and rehabilitation kits will be used for activity training in group 1, the DLA that expected to gain independence will be trained with VBG in group 2. Upper extremity muscle strength and grip, range of motion, upper limb functions, activity, participation and quality of life will be evaluated. The hypothesis of this study is that TOAT with VBG improves the activity performance and physical functions and increases the participation, via being stimulative and interactive in order to provide feedback and to increase interest and motivation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as JIA according to ILAR classification
* Aged between 6-18
* At least one affected joint in upper extremity (shoulder, elbow, wrist, and hand joints)
* Adequate cognitive function in the compliance of exercise program

Exclusion Criteria:

• Surgery or arthroscopic operation in the last year
Noninvasive Vagal Nerve Stimulation

Growing evidence suggests that vagal nerve stimulation (VNS) may be novel and effective in the management of the symptom burden of multiple sclerosis (MS) potentially by reducing inflammation and emotional distress, therefore improving overall well-being.

We will complete a pilot study comparing transcutaneous auricular vagus nerve stimulation (taVNS) and transcutaneous cervical vagus nerve stimulation (tcVNS) to a standard intervention of dorsolateral prefrontal cortex (DLPFC) transcranial direct current stimulation (tDCS) as an active control. The primary outcome will be feasibility and the preliminary efficacy data concerning self-reported symptom reduction to inform the design of an intervention, and estimated power needed to complete a larger sham-controlled RCT. We will also measure heart rate variability (HRV), an easily obtained biomarker of vagus nerve stimulation (VNS), in correspondence to intervention response.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 25-65 years (inclusive)
* Definite diagnosis of MS or related demyelinating disorders (e.g., Neuromyelitis Optica or NMO)
* Stable high efficacy DMT ≥ 6 months before enrollment and throughout the trial
* PDDS score ≤ 6 (established to be able to complete procedures)
* SymptoMScreen Score ≥12
* WRAT-5 ≥85
* SDMT z-score \> -3.0
* K10 \< 35
* Stable disease activity, defined as being more than 1 month after a clinical relapse or confirmed radiologic disease activity, or more than 1 month after steroid treatment
* Ability to use mobile devices

Exclusion Criteria:

* Primary neurologic disorder other than MS and related demyelinating disorders like NMO (e.g., stroke, Parkinson's disease, spinal cord injury, intracranial mass, traumatic brain injury (TBI), epilepsy, mild cognitive impairment (MCI), or dementia), psychiatric disorders or major medical disorders (e.g., history of myocardial infarction, diabetes, thyroid disease, arrhythmia, atrial fibrillation)
* Diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS)
* History of vagus nerve surgery/vagotomy
* History of diagnosed cardiovascular disease, a heart transplant, presence of permanent pacemaker implant or Left Ventricular Assist Device
* Use of certain medications that can affect heart rate variability, such as beta-blockers, calcium channel blockers, and cardiac glycosides
* Use of SP1 inhibitor medications such as Fingolimod, Siponimod, Ozanimod, and Ponesimod
* Nicotine use in the past 6 months (smoking/vaping)
* Pregnant or planning pregnancy during the study period or breastfeeding
* Seizure disorder or recent (\<5 years) seizure history
* Active ear infections or ear pathology
* Current presence of implanted vagus nerve stimulator or any other active implanted electronic devices (e.g., pacemaker, defibrillators, cochlear implants, DBS, iVNS, etc.)
* Presence of metal objects in the head/neck
* Any skin disorder or skin sensitive area near stimulation locations
* BMI ≥ 35
Wellclub Shoulder Therapy Outcome Validation

Preliminary evaluations have been completed and resulted in patients and therapist indicating positive outcomes through increased patient engagement, asynchronous communications (i.e. messaging) between therapists and patients, and objective assessment and monitoring of exercises performed by the patients. The investigator's hypothesis is that patients using the Wellclub device and application in addition to in-clinic physical therapy will be more compliant with their home exercise programs and have the same or better functional outcomes than patients with similar conditions who use in-clinic care only.

Patients seeking an initial outpatient physical therapy evaluation for non-surgical shoulder impingement with pain, who own iPhones with iOS 8 or later. Patients will be randomized into the study group or the control group, and be seen at least once per week by their physical therapist for the duration of the therapy episode, or up to 12 weeks. The study group will be asked to strap to their wrist a small, measurement device and download a smartphone application. The App communicates with the wearable device and reminds them to complete their therapy and provides patients visual instruction, feedback on exercise quality, and exercise count for the prescribed physical therapy. The control group will only have traditional in-clinic therapy as deemed clinically necessary by the PT.

Eligibility Criteria:
Inclusion Criteria:

* Shoulder impingement not requiring immediate surgery

Exclusion Criteria:

* Rotator cuff tear (RCT)
* Surgical history of rotator cuff repair (RCR)
* Cortisone injection or other injectable for past 6 months
* Prescription NSAIDs in the past 6 months
* Frozen shoulder syndrome
* Neurological conditions
* Other orthopaedic conditions (spine/neck)
Magnetic Resonance Imaging and Spectroscopy at High Field

Evaluating novel MR imaging techniques on volunteers.

The aim of this study is twofold. The first aim is to evaluate new MRI techniques developed by the investigators of this protocol on human volunteers. The second aim is to assist other investigators who need to use MR images obtained on this device for their own research. MR images and/or spectroscopy data will be acquired from the participants in this protocol.

Eligibility Criteria:
Inclusion Criteria:

* Healthy normal volunteers for imaging protocol optimization.

Exclusion Criteria:

* Patients with implanted surgical clips (hemostatic clips) or other ferromagnetic material,
* Patients engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities,
* Patients with permanent (tattoo) eye-liner or with facial make-up (severe eye irritation has been reported),
* Patients with compromised thermoregulatory systems (e.g. certain cancer patients),
* Patients with metallic implants, because they may cause artifacts in diagnostic images due to magnetic field distortion,
* Patients with implanted prosthetic heart valves,
* Patients with pacemakers, neuro-stimulation devices,
* Pregnant patients (the safety of magnetic resonance examination has not been completely established for embryos and fetuses),
* Subjects who have received orthodontic work involving ferromagnetic materials,
* Subjects who have claustrophobia, and
* The patients unwilling to participate in the study or fail to sign the consent form.
* Subjects who are pregnant or breast-feeding will be excluded from the contrast enhanced MRI studies.
* Subjects who had allergic response to contrast agents previously will be excluded from contrast enhanced MRI studies.
* Subjects with known history of asthma, allergic conditions, severe renal insufficiency, sickle cell anemia, chronic hemolytic anemia, gastrointestinal disorders will also be excluded from contrast enhanced MRI studies.
Evaluation of the Effectiveness and Safety of AI-Robotics

Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot

Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot developed by AI-Robotics Technology Co., Ltd., Beijing for who had lower limb paralysis

Eligibility Criteria:
Inclusion Criteria:

1. more than18 but less than 60 years old，less than 80 kilos of weight，Gender is not limited
2. Confirmed by MR/CT，AIS spinal cord injury grade: A-C level (without walking ability)：Damage plane T6-L2
3. The muscle tension of the modified Ashworth grade level is less than or equal to 2
4. The range of passive motion of the hip and knee joint of the patient is approximately normal in the ankle joint Neutral position
5. Upper limb strength and physical strength are sufficient to stabilize the crutches
6. Patients are able to understand and actively participate in the training program, agree and sign the informed consent form

Exclusion Criteria:

1. The range of motion of the joints is severely limited and the walking action is limited
2. Spinal fractures are not completely healed, the clinical situation is unstable; if not fully confirmed,please go department of orthopedics or other clinical departments for diagnosing
3. Skin injury or infection of the lower extremities or the part of wearing robot
4. Unstable angina, severe arrhythmia and other heart diseases
5. Severe chronic obstructive pulmonary disease
6. Unilateral neglect
7. Severe cognitive or visual impairment
8. Other contraindications or complications that may affect walking training
9. Pregnant or lactating women
10. The investigators find that patients with poor compliance, unable to complete the study in accordance with the requirements
Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI

This is a pilot prospective, comparative, monocentric, randomized study with 2 groups. People with a severe aortic stenosis and a high risk of surgery are referred to a Trans catheter aortic valve implantation (TAVI).

The proposed study is to show the interest of a cardiac computed tomography (CT) to improve the TAVI procedure. The Cardiac computed tomography (CT) shows the exact geometry of the aortic annulus and help the physician to find the right position of the prosthesis during the procedure. The hypothesis is that performing a cardiac CT before the TAVI could reduce the number of vascular peripheral complication, the number of stroke and can minimize the aortic regurgitation during the follow up.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a symptomatic severe aortic stenosis with a too high risk of surgical valvular replacement. This patient will be selected for a TAVI. In this study, we only randomized patient for a TAVI with an Edwards prosthesis
* male or female patient, older than eighteen years old
* who have given their written consent
* who are affiliated to the French social security system
* which has a too high risk of surgical valvular replacement (EuroSCORE logistic \> 20% or Society of Thoracic Surgeons Score \> 10, or contre indicated to a cardiac surgery by a heart team
* Severe Aortic stenosis with symptoms like dyspnea, heartache, syncope, heart failure

Exclusion Criteria:

* Patient who can't give his written consent because of his physical or mental status
* Adult patient protect by law (article L1121-8),
* Person deprived of liberty (article L1121-8),
* Pregnant women
* Patient in terminal phase of illness,
* Terminal kidney failure
* Allergy to iodine
* bicuspids ou unicuspid aortic,
* Diameter of the left ventricular outflow tract \< 18mm or \> 25mm,
* Diameter of the femoral artery \< 7mm, tortuosity or calcifications
* Septal hypertrophy
* Apical thrombosis.
Amodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children

Artemisinin combination therapies (ACT) are currently recommended for malaria treatment. Artemether-lumefantrine(A-L) and Artesunate+amodiaquine (A+A) have been the most commonly adopted of the recommended ACT regimens. In Ghana, A+A is the current first-line antimalarial treatment in Ghana, but there has been 1 efficacy report of this regimen in Ghana till date. Moreover, the safety of repeated treatments with ACT has been little studied. This study aims to evaluate the efficacy of A+A vs. A-L, as well as the safety of repeated treatments of these regimens in a longitudinal trial in which recruited children will be followed up for 1 year.


Eligibility Criteria:
Inclusion Criteria:

* microscopically confirmed acute uncomplicated falciparum malaria;
* temperature at screening 37.50C or more or history of fever 24 preceding enrollment;
* willingness to comply with follow up schedule;
* written informed consent by accompanying parent or guardian

Exclusion Criteria:

* features of severe malaria or danger signs of malaria
* known intolerance or allergy to any of the study medications
* known treatment with any of the study medications in the month preceding enrollment
* serious underlying disease that may mask outcome assessment
Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T

A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).

Those enrolled in the Booster Study will have had their course of treatment with PROVENGE® immunotherapy and then randomized to the Booster Study to be treated with a single booster dose of sipuleucel-T.

Eligibility Criteria:
Inclusion Criteria:

For a subject to be eligible for participation in this study, all of the following criteria must be satisfied:

1. Potential subjects are men aged ≥18 years who are clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer).
2. Have qualified for on-label PROVENGE® infusion
3. Have received all 3 infusions of PROVENGE® prior to randomization
4. Written informed consent provided prior to the initiation of study procedures
5. Estimated life expectancy ≥12 months

Exclusion Criteria:

A subject will not be eligible for participation in this study if any of the following criteria apply.

1. Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer).
2. Need for systemic chronic immunosuppressive therapy (eg, antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids).
3. Uncontrolled, concurrent illness including, but not limited to the following:ongoing or active infection (bacterial, viral, or fungal), or psychiatric illness that would limit compliance with study requirements,as well as any condition that would preclude a subject from completing PROVENGE® or sipuleucel-T treatment.
4. On experimental or investigational therapy.

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Using Signos mHealth Platform in Adults for Weight Management

Metabolic syndrome and resulting downstream health effects remains a growing health concern. In published trials, the use of continuous glucose monitoring (CGM) assists behavioral changes efforts, leading to improved adherence and results from diet and exercise changes in individuals with obesity. Mobile health (mHealth) platforms provide satisfactory, easy-to-use tools that help participants in the pursuit of weight change goals. The investigators hypothesize that the use of CGM data and targeted coaching and nutrition education will assist with weight optimization goals in the general (non-diabetic) population using the Signos mHealth platform, with associated health benefits.

The scope of this study is to enroll participants into a study that utilizes a continuous glucose monitor (CGM) and mobile health application \[Signos\] to optimize general wellness and body weight and composition. The Signos users will be compared against a control arm.

Eligibility Criteria:
Inclusion Criteria:

To join our study, participant need to:

* Be at least 22 years old.
* Be overweight or obese, which we define as having a Body Mass Index (BMI) between 25 and 40.
* HbA1c test result should be below 6.5% at the start of the study.
* Have and know how to use a smartphone that's compatible with the Signos app.
* Be able to understand, speak, and read English well enough to participate fully in the study.

Exclusion Criteria:

Participant can't join our study if participant has:

* Have Type 1 or Type 2 diabetes.
* Are already using a device to monitor glucose level.
* Have severe allergies to the sticky part of glucose monitors.
* Suffer from an eating disorder like anorexia or bulimia.
* Are currently taking certain medications for diabetes or weight loss.
* Have had or are planning to have weight loss surgery.
* Have major health issues like severe kidney disease, untreated thyroid problems, or skin conditions where the glucose monitor would be placed.
* Have been part of another clinical trial recently.