cyrilzakka/clinical-trials huggingface dataset:
Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation

The purpose of the study is to investigate the best strategy for long-term stroke prevention in patients who have sinus rhythm after a successful catheter ablation for atrial fibrillation (AF) and who are at risk of thromboembolic events (CHA2DS2-VASc score ≥2). The investigators are going to compare antiplatelet therapy to oral anticoagulation (OAC) with different doses of edoxaban (30mg and 60mg).

The investigators hypothesize that the strategy of OAC will be superior to antiplatelet therapy, but low dose edoxaban (30mg) will be non-inferior to standard dose edoxaban (60mg) for reducing the risk of stroke or systemic embolism in patients who underwent successful AF ablation. Although AF ablation is an effective therapy for reducing and/or eliminating the burden of AF, there may continue to be a risk of late recurrence or asymptomatic recurrence of atrial tachyarrhythmias. Until now, the guideline has recommended the continuation of OAC in patients who are at risk of stroke or systemic embolism based on the CHA2DS2-VASc score, even though they have maintained sinus rhythm. The annual rate of stroke, however, is still lower compared to that predicted by the scoring system, because AF ablation reduced the AF burden by 86% and the remaining episodes were significantly shorter in duration (median 6 minutes) than those pre-ablation reported by the previous study. Based on recent studies which demonstrated that both standard-dose and low-dose non-vitamin K OACs (NOAC) performed equally well with regard to the stroke prevention in patients with AF, low dose NOACs may also be sufficient for stroke prevention of briefly lasting AF episodes after successful AF ablation.

Eligibility Criteria:
Inclusion Criteria:

* Patients without evidence of any clinically apparent arrhythmia recurrence during at least six months after last catheter ablation of AF.
* Willing and able to provide informed consent

Exclusion Criteria:

* Patients who do not meet all of the above listed inclusion criteria.
* Patients with significant valvular heart disease or mechanical valve.
* Patients with hypertrophic cardiomyopathy.
* Patients with chronic renal impairment with creatinine clearance rate of \< 30 mg/dl.
* Patients with contraindication to long-term OAC.
* Patients who had a stroke within one year prior to enrolment.
A Clinical Study of Tranilast in the Treatment of Mucinoses

56 participants with Mucinoses will be selected to receive treatment of tranilast. After a period of time ,the investigators can determine the efficacy of the drug by detecting the the thickness and area of skin before and after treatment.

56 participants with Mucinoses will be selected. After the signing of the informed consent ,participants will be collected the initial lesions photos,the thickness and area of skin lesions by ultrasound and magnetic resonance,and chemical examinations including blood routine examination, routine urine test, liver function, renal function. During tranilast (0.1g each time, three times a day,12 months) treatment, participants need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, and every three months to retest lesion thickness and area. With 3 month as a time point, participants were observed for four points. After the experiment, the experimental data will be arranged and the data of the thickness and area change of skin lesions will be statistically processed to determine whether it is meaningful.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical and histopathological examination has been proved to be Mucinoses;
2. Ultrasound and magnetic resonance detection found that the skin was thickened.

Exclusion Criteria:

1. With a liver or kidney disease, or accompanied by a severe infection;
2. Poor control of primary disease;
3. With mental disease.
The Influence of Probiotics on Vancomycin-Resistant Enterococcus

Drinking probiotics in a the form of a yogurt drink will restore normal gastrointestinal (GI) bacteria in patients whose colon are colonized with vancomycin-resistant enterococcus (VRE).


Eligibility Criteria:
Inclusion Criteria:

* VRE positive patients with GI colonization

Exclusion Criteria:

* Age less than 18 years
* Patients who have had a bone marrow transplant
* Extreme short bowel patients (less than 100 cm small bowel remaining)
* Patients with active VRE infection but no GI colonization
* Patients unable to eat and have no feeding access
* Patients who do not have a power of attorney to give consent if they are unable to
The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative

To establish the first systems level continuous quality improvement (CQI) collaborative for multiple sclerosis (MS) in the United States, to conduct benchmarking analyses and assessments of geographic variation in MS care quality and value, and study the effect of CQI interventions on improvement of selected performance (quality) indicators.

This is a three year study which employed a step-wedge randomized design which exposed three of four participating centers to a healthcare QI intervention during the 3 year period. Each of the centers exposed to an intervention served as its own control during a baseline pre-intervention period during the first year of the study. The fourth site served as a longitudinal control for comparison to the other three centers exposed to a QI intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older with documented clinically confirmed MS who are followed by one of the participating MS centers.

Exclusion Criteria:

* Candidates will be excluded from study entry if they are unable or unwilling to provide informed consent.
Investigating Outcomes of Lower Limb Trauma

This is an observational study, which aims to firstly develop a sensor-based objective mobility assessment. This will then be used to profile and compare the outcomes of patients who undergo amputation with those who have limb salvage surgery following a traumatic injury to their lower limb.

In the setting of severe trauma, the decision whether to amputate or save a limb is common, and extremely difficult to make. Due to improving reconstructive surgical techniques there are currently no clear criteria for amputation. Although limb salvage appears desirable in most situations, numerous articles in the scientific literature have shown that it is associated with increased pain, complications, duration of hospital stay, rehabilitation time, and overall costs. These factors may be acceptable if the patients benefited from improved functional outcome. However, studies comparing amputation to limb salvage consistently report no significant difference in functional outcome between the two groups.

A major limitation in the methodology of the fore mentioned studies is the use of self-reported questionnaires to determine functional outcome. Questionnaires are subjective, and often lack specificity, and therefore may not be truly representative of functional outcome. Furthermore, lack of useful information during long-term post-operative care prevents adaption and optimisation of rehabilitation strategies.

The investigators plan on using a wearable sensor to develop an objective mobility assessment tool for patients having either amputation or limb salvage surgery after lower limb trauma. This would result in a reliable and accurate comparison, which may help healthcare professionals make an informed decision between amputation and limb salvage in the future.

Eligibility Criteria:
Inclusion Criteria:

* To have sustained a lower-limb trauma and undergone limb salvage surgery OR amputation with fitting of prosthesis

Exclusion Criteria:

1. Contralateral (or other) limb impairment
2. 18 \> AGE \> 65
3. Currently a hospital inpatient
4. Psychological disorder
Patient Activation Intervention in Improving Screening Rates for Colorectal Cancer

This randomized clinical trial focused on activating the patient to ask their health care provider for a colorectal cancer screening test to improve screening rates for colorectal cancer. The patient activation intervention may increase information seeking, number of screening tests ordered and number of completed screening tests for colorectal cancer.

PRIMARY OBJECTIVES:

I. To test a patient activation intervention to improve colorectal cancer (CRC) screening rates using fecal occult blood test (FOBT) among male and female patients 50 years and older from the East Central Columbus Neighborhood Health Center.

SECONDARY OBJECTIVES:

I. To assess if there is a change in knowledge and attitudes about CRC screening after watching the educational video.

II. To assess the effectiveness of providing communication skills training for improving discussion focusing on CRC screening during the patient-provider visit.

OUTLINE: Patients are randomized to 1 of 2 arms prior to a medical visit.

ARM I (Education only): Patients receive CRC and CRC screening information by an educational video and a brochure with healthy hints to prevent CRC.

ARM II (Education and patient activation): Patients receive CRC and CRC screening information and communication skills training (patient activation) intervention by educational video and brochure and a brochure about healthy hints to prevent CRC.

After the medical visit, patients' medical records are reviewed at 1 month and 2 months after the visit to document CRC screening completion.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 50+ years of age
* Patient is in need of CRC screening
* Patient is in good health (e.g. no contraindications to having CRC screening, such as a history of colorectal cancer, congenital heart failure, renal failure, dialysis, dementia, severe arthritis, etc.)
* Patient is not pregnant
* Patient is able to speak, read, and understand English

Exclusion Criteria:

* Patient is within CRC screening guidelines
* Patient is at high risk for CRC
* Patient cannot understand English
* Patient cannot complete a CRC screening test
The Effect of Eye Exercises in Individuals With Eye Refractive Defects

According to the World Health Organization's statement published in 2014, 43% of visual impairment is overhauled by uncorrected refractive errors. The change of body and angle of light waves while undergoing changes in the environment due to the temperature difference between the environments is called refraction. The refractive errors found in the eye can be discovered as myopia, astigmatism, hyperopia, and presbyopia. As there are different prevalence methods in eye refractive errors in various publications. According to many studies in the literature, eye exercises in many conditions such as convergence collapse, accommodation dysfunction, movement center of the eye, digital eye strain and dry eye are curative and therapeutic without any control. With eye exercises, blood is applied to the ocular region, the humor is stimulated, the tension of the extraocular muscles is reduced, the coordination between the eye muscles is increased, the eye fatigue and stress are reduced. Depending on the effects of these effects, positive changes are seen on vision tests. Although there is a different view in the literature that includes these eye exercises and their benefits, it has been found to be insufficient in current studies. More work needs to be done in this area so that these results can be stated better and more clearly. With this study, investigators aim to shed light on what can be done in this field by filling these residents in the literature and to examine the visual function and quality of life of eye exercises.


Eligibility Criteria:
Inclusion Criteria:

be between the ages of 18-65, Having any refractive or visual impairment (myopia, hyperopia, astigmatism) by an ophthalmologist, not have other eye problems in addition to these vision defects, to score at least 24 on the Standardized Mini Mental Test.

Exclusion Criteria:

having undergone any eye surgery (including laser operations), have a prosthetic eye have congenital vision loss, have any disease that will affect the eyesight. Individuals meeting these criteria will not be included in the study.
Bone Mineral Density in Adults With Hyperphenylalaninemia on Kuvan Therapy

Prospective study to compare the bone mineral density in adults with HPA on KUVAN™ therapy to those not on therapy. The investigators hypothesize that after one year of KUVAN™ therapy, there will be an improvement in their bone mineral density.

Hyperphenylalaninemia (HPA) is a rare metabolic disorder caused by a deficiency of the enzyme phenylalanine hydroxylase (PAH) (NIH, October 16-18, 2000). Elevated plasma levels of phenylalanine (phe) cause mental retardation, microcephaly, delayed speech, seizures, eczema, and behavior abnormalities. Adequate control of the plasma levels of phe by a phe-restricted diet can prevent the developmental and behavioral problems.

The foundation of this diet is a phe-free metabolic medical product/formula made from free amino acids. Based on longitudinal studies, it has been reported that the most benefit is attained by individuals who maintain a phe-restricted diet throughout life. On December 13, 2007, KUVAN™ (sapropterin dihydrochloride) was approved by the FDA for the indication of reducing blood phe levels in patients with HPA due to BH4 responsive PKU, in conjunction with a phe restricted diet (BioMarin Pharmaceutical Inc., Investigator's Brochure March 25, 2008). Studies were performed to determine a definition of response to KUVAN™. In a phase 2 clinical trial in 2007, Burton, et. al. defined a Kuvan™ responder as having a 30% or greater improvement in blood phenylalanine levels compared to baseline after 8 days of drug therapy.

Kuvan™ has been shown to improve phenylalanine tolerance in some individuals with HPA. This drug enables these individuals to consume more protein from natural sources. However, there have been no research studies assessing the effects of KUVAN™ along with liberalization of the diet on bone mineral density.

The investigators propose a prospective study to compare the bone mineral density in adults with HPA on KUVAN™ therapy to those not on therapy. The investigators hypothesize that after one year of KUVAN™ therapy, there will be an improvement in their bone mineral density.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hyperphenylalaninemia at birth
* Age between 18 and 50 years
* Participated in study HSC-MS-110-0262

Exclusion Criteria:

* Peri-menopausal and menopausal women will be excluded because this is a time of increased bone loss related to hormonal mediated factors.
* Patients taking bisphosphonates because it alters bone density. Therefore, bone mineral density would reflect the biphosphonate intervention rather than their true status.
* Pregnant women due to the hazard of radiation exposure during a DXA scan. In addition women who have been pregnant or who have breastfed within one year of study enrollment will be excluded because these are periods of rapid bone loss which would not reflect the entity under study but would serve to confound the data.
Sleep Quality and Cognition in Young Adults

Sleep quality is impaired in young adults due to current conditions. Recent studies emphasize that this situation may also affect the cognitive status of individuals. The aim of this study was to investigate the relationship between sleep quality and cognitive status in young adults. A total of 122 young adults (61 female, 61 male) aged between 18 to 25 and studied at Istanbul Medipol University, Faculty of Health Sciences, were included in the study. Individuals were evaluated with "Pittsburgh Sleep Quality Index (PSQI)" for sleep quality; with "Montreal Cognitive Status Scale (MoCA)" for cognitive status, with "STROOP Test" for selective attention; with "Verbal Fluency Test" for sustained attention; with "WMS-R digit Span Test" for auditory attention


Eligibility Criteria:
Inclusion Criteria:

* Signing the Informed Voluntary Consent Form
* Being in the age range of 18-25

Exclusion Criteria:

* having a sleep disorder
Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage

In this prospective, single arm, open label, clinical trial, a total of 50 acute leukemia of ambiguous lineage patients will be enrolled. Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) after CR . Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors. The purpose of current study is to evaluate the clinical efficacy of ALL-based chemotherapy，effect of genetic abnormality and minimal residual disease (MRD) on prognosis in patients with acute leukemia of ambiguous lineage.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged above 14 years with acute leukemia of ambiguous lineage .
2. Eastern Cooperative Oncology Group (ECOG) Performance status 2.
3. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); serum glutamic-oxaloacetic transaminase(SGOT) and serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; Patients must have adequate cardiac function (ejection fraction ≥ 45 % on Multiple Gated Acquisition (MUGA) scan).
4. Patients must have the following laboratory values (≥ lower limit of normal (LLN) or corrected to within normal limits with supplements prior to the first dose of study medication.): Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN
5. Patients should sign informed consent form.

Exclusion Criteria:

1. Impaired cardiac function:

   Long QT syndrome or a known family history of long QT syndrome; clinically significant resting brachycardia (\<50 beats per minute); ejection fraction \< 45 % on MUGA scan. Corrected QT (QTc) interval \> 450 msec on baseline ECG (using the QTcF formula). If QTcF interval\>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc. Myocardial infarction within 12 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).
2. Other concurrent severe and/or uncontrolled medical conditions:

   Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.
3. Patients who are: (a) pregnant and (b) breast feeding.
Different Surgical Drilling Protocols in Posterior Maxilla

Sixteen dental implants inserted in sixteen patients who were selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, for the rehabilitation of missed single maxillary posterior tooth by an immediately loaded dental implants

16 dental implants were inserted in 16 patients were divided into two groups: Group A: 8 dental implants were inserted using undersized drilling technique and Group B: 8 dental implants were inserted using single drilling technique. then the dental implants were assessed for 6 months regarding

Clinical Evalution: regarding these parameters after immediately dental implants loading,3 months and 6 months.

implant stability, implant probing depth, bleeding index.

Radiographic evaluation: immediately after implant loading and 6 months after loading regarding bone density and marginal bone loss.

Eligibility Criteria:
Inclusion Criteria:

* Patients with missed one or more posterior maxillary tooth.
* Be older than 18 years and of residual bone height more than10 mm.
* Patients with good oral hygiene and willing to participate in the follow-up sessions.
* Patients with adequate mesio-distal width and inter-arch space.
* Patients without any para-functional habits such as clenching and bruxism.

Exclusion Criteria:

* Patients whose proposed surgical site had any pathological lesion or root tips.
* Drug or alcohol abuse.
* Patients with uncontrolled systemic diseases.
* Pregnant patients.
* Tobacco use more than fourteen cigarettes daily.
PEComas: Natural History and Prognostic Factors

Perivascular epithelioid cell tumors are rare and characterized by the expression of myomelanocytic markers. They belong to a complex tumor family that includes angiomyolipomas, lymphangioleiomyomatosis and other soft-tissue tumors. Given their rarity, the natural history of pecomas is not yet understood, and a comprehensive classification that integrates clinical, pathological and molecular features has not been achieved as of today.

This study is a national multicenter retrospective study to better understand the natural history of PEComas, excluding lymphangioleiomyomatosis and classic triphasic angiomyolipomas.

The primary purpose is the identification of prognostic markers impacting the relapse. Secondaries purposes are to identify prognostic markers impacting the overall survival and to have a better understanding of natural history


Eligibility Criteria:
Inclusion Criteria:

* Major patient (≥18 years old)
* Minor patient (1 to 17 years old)
* PEComas diagnosed in France between 1990 and 2018 and read back by a pathologist referent of sarcomas
* Patient having agreed to the use of his medical data for the purpose of this research.
* Parental authorities having given their agreement for the reuse of their child's medical data for the purpose of this research.

Exclusion Criteria:

* Opposition of the patient (or his legal representative) to the reuse of his data for the purposes of this research
* Impossibility of giving the subject clear information
* Patient under safeguard of justice
* Patient under guardianship
* Lymphangioleiomyomatosis
* Classic triphasic angiomyolipoma
Foraminal Enlargement and Postoperative Pain.

The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in teeth with necrotic pulp and apical periodontitis.

Foraminal enlargement (FE) is an intentional procedure that enlarges the cement canal. However, some RCTs indicate that enlarging the FE causes postoperative pain, flare-up, and destroy the apical constriction, whilst some RCTs pointed out there is no difference in terms of pain when a FE has been performed. The investigators, therefore, would like to conduct a RCT to increase both sample size and the number of published studies to do a systematic review for this topic.

Eligibility Criteria:
Inclusion Criteria:

* Mature permenent teeth having pulpal necrosis and apical periodontitis.

Exclusion Criteria:

* Systemic disorders
* Diabetes
* Pregnancy
* Less than 18 years of age
* Immunocompromised
* Patients who had taken antibiotics in the past 1 month
* Patients who had a positive history of analgesic use within the past 3 days
* Previously accessed teeth