cyrilzakka/clinical-trials huggingface dataset:
Photodynamic Therapy in Endodontic Treatment

This randomized clinical trial evaluated the effectiveness of supplemental photodynamic therapy (PDT) in optimizing the removal of bacteria and endotoxins from primarily infected root canals after one-visit and two-visit treatments.Twenty-four primarily infected root canals with apical periodontitis were selected and randomly divided into one-visit (n=12) and two-visit treatments (n=12). Chemo-mechanical preparation (CMP) was performed by using the single-file reciprocating technique + 2.5% NaOCL and a final rinse with 17% Ethylenediamine tetraacetic acid (EDTA). The photosensitizer agent (methylene blue 10 mg/mL) was applied to root canals for 60 seconds and submitted to laser with a potency of 60 milliwatts (mW) and energy density of 129 J/cm2 for 120 seconds after CMP in the one-visit treatment and after 14-day inter-appointment medication with Ca(OH)2 + saline solution (SSL) in the two-visit treatment. Samples were collected before and after root canal procedures. Endotoxins were quantified by chromogenic limulus amebocyte lysate assay. Culture techniques were used to determine bacterial colony-forming unit counts.


Eligibility Criteria:
Inclusion Criteria:

* single-rooted maxillary ones with primary endodontic infection and showing presence of one root canal and absence of periodontal pockets deeper than 4 mm.

Exclusion Criteria:

* Those who had received antibiotic treatment during the past three months were excluded.
* The teeth that could not be isolated with rubber dam were also excluded.
* Presence of root canal calcification.
ECG Belt for CRT Response

The purpose of this clinical study is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling.

The ECG Belt study is a prospective, interventional, randomized, multi-center, investigational, pre-market research study. The ECG Belt Research System will be used at implant and follow-up to help implanters choose a suitable LV pacing site within the recommended locations for LV lead implantation and optimize pacing vector/timing parameters.

Eligibility Criteria:
Inclusion Criteria:

* Indicated for CRT, with QRS duration ≥130 ms, and planned to be implanted with a market-released Medtronic CRT device with AdaptivCRT and a Medtronic quadripolar LV lead.
* Meets at least one of the following criteria: QRS duration \< 150 ms, Prior documented Myocardial Infarction, Non-LBBB
* LVEDD ≥ 55 mm, as determined by site

Exclusion Criteria:

* Permanent/persistent AF or presenting with AF
* Pre-existing or previous LV lead or other confounding devices e.g. Left Ventricular Assist Device, Vagal Nerve Stimulator
* Currently implanted with IPG or ICD with \> 10% RV pacing
* Permanent complete AV block
* Enrolled in a concurrent study that may confound the results of this study. Pre-approval from the study manager is required for enrollment of a patient that is in a concurrent study.
* Less than 1 year life expectancy
* Vulnerable adults
* Younger than 18 years of age
One Versus Two Unit Transfusions in Oncology Patients - The OTTOP Trial: A Randomized Open-label Pragmatic Controlled Trial

The aim of this trial is to determine if the transfusion of one unit of red blood cells to anemic oncology patients results in comparable numbers of transfusion episodes when compared to transfusion of two units of red blood cells.

The aim of this trial is to determine if administration of one unit of red blood cells to anemic oncology patients is non-inferior to the administration of two units of red blood cells in terms of the number of annual transfusion episodes. If demonstrated, our findings will cut the total transfusion episode time in half and avoid exposure to an additional unit of red blood cells while freeing up scarce hospital resources.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years of age with solid tumour (non-hematologic) malignancy undergoing chemotherapy
* Requiring a red blood cell transfusion as determined by their treating oncologist

Exclusion Criteria:

* Active bleeding (WHO grade 3 and 4)
* Known history active hemolysis
* Inpatient admission
* Refusal to receive red blood cell transfusion
* Unwilling or unable to provide informed consent
Effectiveness of a Rehabilitation Program in Improving Quality of Life in Patients With Esophageal Cancer

This study will investigate the effectiveness of a rehabilitation program in improving sleep quality, emotional distress, circadian rhythms, and quality of life in patients with esophageal cancer in Taiwan.

Hypothesis:

1. The quality of life in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.
2. The quality of sleep in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.
3. The emotional distress in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.
4. The circadian rhythms in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.

This study will investigate the effectiveness of a rehabilitation program in improving sleep quality, emotional distress, circadian rhythms, and quality of life in patients with esophageal cancer in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

* Patients with esophageal cancer who were aged ≥20 years, could communicate in either Mandarin or Taiwanese, and were not cognitively impaired were included.

Exclusion Criteria:

-
Medial Patellofemoral Ligament Reconstruction With or Without Lateral Retinaculum Release

The investigators hypothesis is lateral retinaculum release has no effect on treatment of Patellar Recurrent Dislocation with Medial Patellofemoral Ligament (MPFL) reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* age between 18yo and 45yo
* indication for MPFL reconstruction
* unilateral or bilateral indication

Exclusion Criteria:

* indication for bony procedures
* previous surgery for PF disorders
* patient refusal
Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement

The purpose of this study is to 1) examine barriers and facilitators to implementation of MI and MORE for polysubstance use and evaluate strategies for optimizing training, fidelity, and clinic uptake, and 2) evaluate patient outcomes related to the effectiveness of MORE decreasing opioid, tobacco, and other drug use.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Age ≥18
* Currently on methadone; and 4) currently smoke cigarettes.

Exclusion Criteria:

* Severe cognitive impairment (score \>23 on Mini Mental Status Exam) or psychosis (positive SCID Psychotic Screen)
* Suicidal risk (score ≥7 on Suicidal Behaviors Questionnaire)
* Inability to attend or fully participate in intervention sessions or assessments
* Previous formal mindfulness training (e.g., MBSR, MBRP) or MORE (from the R21 or R33
* Currently taking smoking cessation pharmacotherapy or participating in smoking cessation counseling
* Any contraindications for NRT
* Currently or soon planning to be pregnant or breastfeeding.
Effects of Combined rTMS and Treadmill Training in People With Parkinson's Disease

The purpose of this study is to investigate whether the beneficial effect of treadmill training on people with Parkinson's disease can be enhanced by high- and low-frequency repetitive transcranial magnetic stimulation (rTMS).

This is a randomised placebo-controlled trial. Fifty-one participants with Parkinson's disease (PD) will be recruited from the Hong Kong PD association, a self-help group and movement disorders clinic of 3 local hospitals. Written informed consent in accordance with the Declaration of Helsinki will be obtained from all participants. Eligible participants will be randomly assigned into one of the three groups: 1Hz-TT, 25Hz-TT, and sham-TT upon recruitment. Randomisation will be generated by a computer program and group assignment will be blinded to both participants and assessor. Participant will receive either 1-Hz, 25-Hz, or sham rTMS which will last for about 20 minutes followed by 30 minutes treadmill walking training for 12 sessions, 4 times per week for 3 weeks. All assessments will be conducted 1 week before intervention and 1 day after completion of intervention, after 1-month training and at 3-month post training.

The sample size calculation is based on the significant findings of the gait speed reported by Yang et al (2013). A two-way repeated measures ANOVA design with between-subject group effect (3 levels) and within-subject time effect (4 levels) determines that 15 subjects per group are required to achieve 85% power to test the interaction effect between groups and time effect with a 5% significance level and the effect size is 0.2. By assuming 10% dropout rate, 17 subjects will be required per group.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with idiopathic Parkinson's disease by a neurologist
* had been stable on anti-Parkinsonian medication
* able to walk independently for 30 meters

Exclusion Criteria:

* severe co-morbidity that may interfere with their ability to participate including significant orthopaedic or rheumatological conditions or disorders of peripheral nervous systems that may interfere with mobility or balance performance
* a diagnosis of neurological disease other than PD
* a history of psychiatric disorders
* the impossibility of inducing motor evoked potentials (MEPs)
* a score of less than 24 on the Mini-Mental State Examination
* contraindication to TMS including personal or family history of seizure disorder, metal in the head, implants of medical devices such as cardiac pacemakers or medical pumps, females subjects who are pregnant, a history of neurosurgery
* subjects with irrepressible tremor and / or dyskinesia
Life Quality Study for PFAPA Patient

This cohort study aims to assess the quality of life (or welfare) related to the health of children and adolescents with an non genetics auto-inflammatory disease PFAPA or Marshall syndrome to compare it to children or adolescents with recurrent fever genetics of Familial Mediterranean fever (FMF) in order to improve their overall care.


Eligibility Criteria:
Inclusion Criteria:

* PFAPA syndrome patients or FMF patients

Exclusion Criteria:

* Participation refusal
Multi Institutional Study in Patient Presenting With Hematuria

The primary objective of this study is to evaluate the performance of the methylation marker panel for the detection of bladder cancer in patients with gross or microscopic hematuria.

The primary objective of this study is to evaluate the performance of the methylation marker panel for the detection of bladder cancer in patients with gross or microscopic hematuria.

The secondary objective is to evaluate the predictive accuracy of a risk model including clinical factors such as age, gender, smoking history, and presence of gross versus microscopic hematuria compared to a model incorporating the same risk factors along with the methylation marker panel.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is willing and able to give written informed consent
2. Subject presents with or has a history of gross hematuria or microhematuria within the last 3 months

Exclusion Criteria:

1. Subject has an active urinary tract infection, current urinary retention, active stone disease (renal or bladder), current ureteral stents or nephrostomy tubes, prior bowel interposition, or recent genitourinary instrumentation (within 10 days)
2. Subject has a current or past history of genitourinary or urologic cancer within 5 years
3. Subject has an active (untreated) cancer of any type, except basal cell skin cancer within 5 years
Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease

Hypothesis:

Tissue and serum samples collected from end-stage heart failure patients receiving left ventricular assist device implantation (LVAD) or heart transplantation will provide information regarding the basic science of heart disease. Tissue and serum samples collected from a limited numbers of "healthy controls" (donor grafts that were not utilized for heart transplantation) will serve as a comparator in research database projects.

Design:

This is a registry project; there are no investigational treatments, drug or procedures associated with participation in registry activities. This project is an organized functional data and tissue data gathering and storing (database) endeavor with specific focus on the functional, structural, and molecular aspects of heart failure. Data collection will not immediately influence the course of treatment for any patient.

Brief description of procedures:

After informed consent is obtained from the patient, the blood samples will be obtained either during a procedure from access lines inserted for the procedure or they will be drawn when other ordered lab work is done at specific time points during the study. Tissue samples will be obtained at the time of LVAD implantation by keeping the part of the left ventricular apex that the surgeon is removing in order to place the inflow cannula of the LVAD. No extra tissue sample, other than the tissue that has to be removed as a part of a standard LVAD, will be collected.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age diagnosed with heart failure undergoing either LVAD implantation or heart transplantation
* 13 to 18 years of age, specifically, older children with heart failure whose body mass index is large enough to accommodate and LVAD

Exclusion Criteria:

* Neither patient nor patient representative understands spoken English
* Neither patient nor patient's personal representative is willing to give written consent for participation.
Efficacy, Safety, and Tolerability of SR750 in Patients With Trigeminal Neuralgia

The goal of this clinical trial is to evaluate the efficacy，safety and tolerability of SR750 in patients with trigeminal neuralgia (TN). Patients will receive SR750 (study drug) or placebo for 6 weeks and keep a diary of daily pain. The study duration for each patient is up to 11 weeks.

This is a phase 2, randomized, double-blind study comparing SR750 with placebo in patients with trigeminal neuralgia. It consists of a screening period, a double-blind treatment period, and a post-treatment safety follow-up period. Baseline pain intensity and number of paroxysms will be taken in the run-in period of screening period and will be checked for eligibility. Around 162 eligible subjects will be recruited and randomized into three arms at 1:1:1 ratio to receive SR750 high dose twice a day (BID) , SR750 low dose BID or placebo BID for 6 weeks. Subjects, investigators, all clinical study site staffs, and the Sponsor will remain blinded to treatment assignment during the study. Subjects will be asked to record the number of paroxysms of pain, severity of daily average pain of paroxysms and severity of daily worst pain in e-diary over the last 24 hours every night before going to bed. After completion of double-blind period, subjects will continue to complete the safety follow-up.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of trigeminal neuralgia as per International Classification of Headache Disorders third version (ICHD-3) criteria for at least 3 months prior to screening
* Subjects must have completed at least 5 daily pain score and experienced ≥3 paroxysms per day with a daily average pain sore of ≥4 on PI-NRS during the seven days of run-in period.
* Willing and able to undergo washout of prohibited medication as per protocol requirements and refrain from use of the prohibited medication throughout the study period.
* Female subjects must be non-pregnant and non-lactating.

Key Exclusion Criteria:

* Secondary trigeminal neuralgia
* Painful trigeminal neuropathies
* Other pains that cannot be clearly differentiated from the pain associated with TN or may interfere with the pain assessment
* Subjects have previously undergone microvascular decompression (MVD), sensory rhizotomy of trigeminal nerve, radiofrequency ablation (RFA), percutaneous balloon compression (PBC), permanent lesion of trigeminal semilunar ganglion, botulinum toxin type A for the treatment of TN within 6 months prior to screening. Subjects with severe complication after therapeutic procedure would also be excluded.
* Known history of human immunodeficiency virus (HIV) or active infection of hepatitis B virus (HBV), hepatitis C virus (HCV) or Treponema Pallidum
Extraction Space Consumption and Overjet Reduction After Maxillary Anterior Enmasse Retraction in Orthodontics

Extraction space consumption and overjet reduction after maxillary anterior enmasse retraction in orthodontics

The Relation between Extraction Space Consumption and Overjet Reduction during Maxillary Anterior En-Masse Retraction by Two Levels of Force Application

Eligibility Criteria:
Inclusion Criteria:

* 1. Young adult male and female patients (Age range from 18 to 25 years) with maxillary dental protrusion.

  2. Patients with Angle class I or class II division I malocclusion with maxillary anterior teeth protrusion and proclination. 3. Skeletal class I. 4. Healthy compliant and motivated patient. 5. No missing of any tooth except wisdom teeth. 6. Good oral hygiene.

Exclusion Criteria:

* 1. Previous orthodontic treatments. 2. Any systemic or bone diseases. 3. Pregnant and lactating patient. 4. Smoking history. 5. Presence of periodontal diseases. 6. Previous maxillary anterior surgery. 7. Gingival overgrowth.
Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

Recently, intravitreal bevacizumab (Avastin) injection has gained popularity as a potential treatment of intraocular neovascularization (CNV) associated with age related macular degeneration and diabetic retinopathy. The efficacy of the drug is thought to be related with its pharmacologic blockade of VEGF.

The purpose of this study is to determine the effect of the intravitreal bevacizumab on the fibrovascular membrane associated with proliferative diabetic retinopathy by objective histologic evaluation.

The patients scheduled for vitrectomy for tractional fibrovascular membrane due to proliferative diabetic retinopathy will be randomized into two treatment groups. The one will receive conventional vitrectomy and the other group will receive intravitreal bevacizumab injection one week before the scheduled vitrectomy. The fibrovascular membrane will be excised during surgery and fixated for histologic examinations. The expression of VEGF and PEDF, a potent inhibitor of angiogenesis, will be evaluated in the fibrovascular membrane by immunohistochemistry. The results will be compared between two treatment groups.


Eligibility Criteria:
Inclusion Criteria:

* Tractional retinal detachment recently involving the macula with fibrovascular membrane due to proliferative diabetic retinopathy
* Severe fibrovascular proliferation progressing after appropriate panretinal photocoagulation

Exclusion Criteria:

* Uncontrolled systemic hypertension
* Recent history of myocardiac infarction within 6 months
* Recent history of cerebrovascular accident within 6 months
Comparison of 4.5/6.5F and 7.5/9.5F Ureteroscopes in Endoscopic Ureteral Stone Treatment

This study aims to compare the efficacy, success rates, and stone-free rates of endoscopic ureteral stone treatment performed using two different sizes of ureteroscopes. Additionally, the psychological stress experienced by the surgeon will be evaluated immediately before and immediately after the procedure using the six-item short-form of the State Scale of the Spielberger State-Trait Anxiety Inventory (STAI). The findings will provide insight into the impact of ureteroscope size on procedural outcomes and surgeon stress levels, contributing to the optimization of ureteroscopic stone treatment.

Patients admitted to our clinic with ureteral calculi and scheduled for ureteroscopic lithotripsy will be informed about the procedure, potential complications, and routine protocol by the investigator. Patients who consent to the operation will subsequently receive detailed information about the study. Those agreeing to participate will provide written informed consent.

During the ureteroscopy procedure, standard clinical protocols will be followed. The choice of ureteroscope (4.5-6 Fr or 7.5-9.5 Fr) will be made by the operating urologist based on the patient's ureteral orifice and ureteral width. The study will not influence the selection of the ureteroscope. Intraoperative parameters, including procedure duration, complications, Double-J stent placement, failure to access the stone, and basket use, will be recorded by the research team.

To assess the impact of ureteroscope size on surgical stress, the operating surgeon's stress levels will be evaluated immediately before and after the procedure using the six-item short-form of the State Scale of the Spielberger State-Trait Anxiety Inventory (STAI).

Postoperatively, all patients undergoing ureteroscopic lithotripsy will undergo a supine direct abdominal radiograph on postoperative day 1, as per routine clinical practice. Stone-free status will be determined based on this radiograph and recorded by the investigator. Throughout the study period, no modifications to standard clinical procedures will be made.

Eligibility Criteria:
Inclusion Criteria:

* Presence of ureteral calculi
* Use of Ho:YAG laser in ureteric lithotripsy
* Patient's acceptance to participate in the study

Exclusion Criteria:

* Presence of active urinary tract infection
* Emergency operation of the patient
* Presence of bilateral ureteral calculi
* Patient refusal to participate in the study
Quantification of Hepatic Fibrosis by IVIM Sequences in 1.5T MRI

Quantification of hepatic fibrosis by IVIM sequences in 1.5T MRI.

Early and accurate diagnosis of hepatic fibrosis in patients with chronic liver disease is essential and essential. This assessment could be performed by a non-invasive MRI method.

The main objective of this study is to show that the measured perfusion-related scattering value (D \*) is related to the hepatic fibrosis stage.

Secondary objectives

* Evaluation of infusion fraction (f) and fibrosis stage.
* Evaluation of molecular diffusion (D) and fibrosis stage.
* Evaluation of ADC and fibrosis stage.
* Assess whether there is a link between the etiology of fibrosis and the value of the diffusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing hepatic biopsy (trans-parietal or trans-jugular) in the context of liver disease
* Signature of written consent

Exclusion Criteria:

* Contra-indications to MRI
* Refusal of protocol
* Underage patients and protected adults