cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Safety and Effectiveness on Oral Anticoagulants

This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating treatment


Eligibility Criteria:
Inclusion Criteria:

* Individuals greater than or equal to 20 years old as of the index date
* At least 1 diagnosis of NVAF prior to or on index date, identified by any medical records
* Newly treated with warfarin or apixaban between 01-Jan-2011 to 31-Dec-2016. The first warfarin or apixaban prescription date during the identification period will be designated as the index date

Exclusion Criteria:

* Patient's medical records indicating pregnancy during the follow-up period
* Patient's medical records indicating taking warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 6-months prior to the index date
* Had \> 1 OAC prescription in the patient's medical records on the index date

Other protocol defined inclusion/exclusion criteria could apply
The Evaluation Clinical Results of Coronally Advanced Flap With Platelet Rich Fibrin

The aim of this study was to evaluate the clinical outcomes of platelet- rich fibrin and coronally advanced flap technique in the treatment of multiple gingival recessions in comparison with connective tissue graft technique.

Aim of this study was to evaluate the clinical outcomes of platelet rich fibrin (PRF)+coronally advanced flap (CAF) technique in the treatment of multiple gingival recessions in comparison with connective tissue graft (CTG)+CAF technique.12 patients with bilateral Miller Class I multiple gingival recessions were treated with PRF+CAF (test group) and CTG+CAF (control group) technique in a split-mouth study design. Probing depth, recession depth (RD), clinical attachment level (CAL), recession width, position of gingival margin, papilla width, keratinized tissue height (KTH), keratinized tissue thickness (KTT) were measured at baseline and 3, 6 and 12 months after surgery. Root coverage (RC) and complete root coverage (CRC) ratios were evaluated post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients had at two quadrants, adjacent Miller Class I and at least 2 mm or deeper recessions
* Full mouth plaque score 20% and Full mouth bleeding on probing 10%
* no active periodontal disease,
* involving incisors, canines and premolars,
* age ≥ 18 years

Exclusion Criteria:

* Patients with general diseases which could affect healing process,
* smokers
* Patients had undergone periodontal surgery during the pervious 24 months on the involved sites,
* pregnant or breastfeeding women
* endodontic lesions or non-detectable cemento-enamel junctions at experimental teeth
Feasibility Study of Exercise Training for Abdominal Aortic Aneurysm Disease

An abdominal aortic aneurysm (AAA) is a weakened and enlarged area in the abdominal aorta, which is a large blood vessel in the abdomen. Large AAAs (\>55 mm diameter) carry a high risk of rupture, a surgical emergency that often leads to death due to severe internal bleeding. It has been suggested that regular exercise training might limit the rate at which AAAs develop. However, little is known about the safety and effectiveness of exercise training in these patients. This pilot study will examine the feasibility of supervised aerobic exercise training for patients with small AAAs (30 to 49 mm diameter). The investigators hypothesize that exercise training will be safe and useful for patients with small AAAs.

Abdominal aortic aneurysm (AAA) disease is a potentially lethal health problem of older adults. New screening initiatives will identify many individuals with small (30 to 49 mm) AAAs for which there are currently no treatment options. Regular aerobic exercise might retard AAA disease progression, but the feasibility and acceptability of aerobic exercise in patients with AAA disease has yet to be established. This pilot study will examine the feasibility of supervised aerobic exercise and exercise advice-only in patients with small AAAs. A total of 60 volunteers will be recruited and randomly allocated to one of the two groups. Patients in the supervised exercise programme will be offered three supervised cycle ergometry/treadmill-walking sessions for a period of 12 weeks. The feasibility of each intervention will be assessed in terms of recruitment and compliance, attrition, changes in cardiopulmonary fitness and objective measures of free-living physical activity. Changes in aneurysm size and blood markers associated with disease progression will also be monitored and the impact of the interventions on health-related quality of life assessed using a questionnaire. Outcomes will be assessed at baseline and 12 weeks. We will also conduct focus groups at the end of the trial to obtain qualitative feedback from patients. The results of this study will inform the design of a multi-centre randomised controlled trial with longer-term follow-up of clinical end-points.

Eligibility Criteria:
Inclusion Criteria:

* Men or women identified as having a stable 30 to 49 mm asymptomatic, infra-renal AAA, measured using high-resolution B-mode ultrasonography
* Ability to undertake exercise testing and training

Exclusion Criteria:

* Patients with large (\>50 mm)/symptomatic AAAs
* Patients with contraindications to exercise testing/training (e.g. severe hypertension, unstable metabolic/cardiopulmonary conditions, musculoskeletal injuries etc...)
* Patients who are unable to travel to the testing and training facility at Sheffield Hallam University
* Patients who are already participating in regular exercise
* Patients with a mental impairment that would render consent unethical or would make compliance difficult (e.g. dementia or Alzheimer's)
Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy

We hypothesized that to reduce the adverse effects of intravitreal bevacizumab on ocular tissue and whole body, intravitreal injection of a low concentration of bevacizumab and conducting vitrectomy shortly after the injection is useful. In the present prospective, double-masked, randomized, controlled study, we aimed to verify the usefulness of intravitreal injection of 0.16 mg/0.05 ml bevacizumab one day before conducting vitrectomy for PDR.

Early postoperative hemorrhage in proliferative diabetic retinopathy (PDR) patients is a major complication. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) has reported to reduce vitreous hemorrhage. Recently, numerous reports have shown the efficacy of reducing neovascularization activity before vitrectomy by preoperative intravitreal injection of anti-VEGF agents. When intravitreal bevacizumab (IVB) injection is used as an adjunct therapy, a shortterm effect is needed. Because it is reported some adverse events caused by bevacizumab injection. Hattori et al reported intravitreal injection of 0.16 mg/0.05 ml bevacizumab in PDR patients marked blockage of intravitreal VEGF concentrations in the pilot study. The purpose of this study is to evaluate low dose of intravitreal bevacizumab as a preoperative adjunct therapy reduce the postoperative vitreous hemorrhage. This study involves PDR patients who underwent vitrectomy between May 2012 and August 2013 at Surugadai Hospital of Nihon University. The risks to participants are accompanied by the intravitreal injection of bevacizumab (especially the possibility of endophthalmitis and thromboembolic events).

Between June 2012 and August 2013, one investigator (AM) randomized PDR patients with an indication for primary 25-gauge vitrectomy into a sham group and an IVB group. One day after injection, three surgeons except AM conducted the surgeries. Vitreous samples were collected at the start of surgery, and intraoperative and postoperative complications were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)
* Indicated for vitrectomy

Exclusion Criteria:

* History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection of steroids or retinal photocoagulation within 6 months
Comparison Between Contact Force Guided and Blinded Strategy on PV Isolation in AF Patients

Pulmonary vein (PV) isolation is very important in atrial fibrillation (AF) catheter ablation. PV reconnection is one of the main reasons in AF recurrence. Contact force-sensing catheter is a new catheter which has valuable tools to monitor and increase the efficacy of PV isolation. Previous paper reported the efficacy of contact force-sensing catheter on immediate PV isolation and outcome. However, there might be confounding factor as inter-individual variation. Therefore, we would like to compare the efficacy of contact force-sensing catheter within same patient but different veins.

In this study, we would like to confirm the efficacy of contact force-sensing catheter on immediate PV isolation outcome within same patient. This study randomized the right or left PVs whether to use the contact force-sensing function or not. The study design will minimize the inter-individual variation on evaluating the efficacy of contact force-sensing catheter on immediate PV isolation.

Also, in patients who had recurred AF or AT, we would like to evaluate the long-term efficacy of contact force-sensing catheter on PV isolation.

Sixty patients will be randomized to select right or left pulmonary veins whether to apply contact force-guided ablation or contact force-blinded ablation strategy. Each PV will be ablated with same contact force-sensing catheter (Thermocool Smart Touch Catheter, Biosense Webster Inc. CA). The PV (right or left) which will be randomized to contact force-sensing PV or blind PV. Contact force-sensing PV will be ablated guided by contact force, whereas the blind PVs will be ablated without contact force-sensing information. The change of impedance, total ablation and time to ablate PV will be collected and analysed according to contact force-sensing strategy. After exit and entrance block by conventional method, dormant conduction will be evaluated by using adenosine. The proportion of dormant conduction will be compared between contact force-sensing guided or blinded strategy.

During 1-year follow up, patients who recurred AF or AT will be undergo second ablation procedure. In these patients, PV reconnection rate will be evaluated by a duodecapolar lasso circular mapping catheter. We would like to know whether PVs which have ablated with contact force-sensing information at index procedure have less reconnection than those which was ablated without contact force-sensing information.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic paroxysmal atrial fibrillation (AF) who had failed with anti-arrhythmic agents.

Exclusion Criteria:

* Patients who had previous ablation for AF
* Patients with symptomatic persistent AF
Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

The purpose of this study was to assess the safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee.

This study was a double-blind, randomized, single dose design. The study was conducted in male and female patients ≥40 years of age with OA of the knee. Approximately 450 patients with OA of the knee were randomized to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:

* 32 mg FX006,
* normal saline (placebo), or
* 40 mg TCA IR.

Randomization was stratified by weekly mean of the average daily (24-hour) pain intensity (ADP) scores at baseline, with the following classifications: 5 to \<6, 6 to \<7, and ≥7.

Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 \[baseline\], Weeks 4, 8, 12, 16, 20, and 24). The study was expected to enroll in approximately 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
* Male or female \>=40 years of age
* Has symptoms associated with OA of the index knee for at least 6 months prior to Screening
* Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
* Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray
* Index knee pain for \> 15 days over the last month
* Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
* Body mass index (BMI) ≤ 40 kg/m2
* Willingness to abstain from use of restricted medications

Exclusion Criteria:

* Any condition that could possibly confound the patient's assessment of index knee pain in judgement of the investigator (i.e., iIpsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassification, pain in any other area of the lower extremities or back that is equal or greater than the index knee pain)
* Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease
* History of infection in the index knee
* Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
* Unstable joint within 12 months of screening
* IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
* IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
* Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1 month of Screening
* Any other IA investigational drug/biologic within 6 months of Screening
* Prior use of FX006
* Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Effect of a Rehabilitation Program to Improve Quality of Life in Women Diagnosed With Endometriosis (Physio-EndEA Study)

Given (1) the high volume of women on reproductive age that have a clinical diagnosis of endometriosis and (2) the poor management of symptoms that medical treatment usually achieves, new therapeutic interventions need to be evaluated in order to improve pain and quality of life in those patients. Therefore, 'Physio-EndEA' study has been designed to evaluate whether therapeutic exercise could help on the management of endometriosis-related symptoms

Background: Prevalence of endometriosis is approximately 10% of women of childbearing age. Pain, considered in its multiple versions (dysmenorrhea, dyspareunia, dyschezia, dysuria and, in general, chronic pelvic pain) is the most common and disabilitating symptom in affected women. Usual care, consisting on palliative pharmacological treatment in combination with surgery, is clearly insufficient and physical therapies need to be explored in order to reduce pain and to improve quality of life in affected women.

Objective: The overall objective of 'Physio-EndEA' study will be to explore potential short and mid-term benefits of a rehabilitation program on the quality of life of symptomatic women.

Methods: A total of 26 symptomatic endometriosis women will be recruited. Inclusion criteria includes: aged 18-50, clinical diagnosis of endometriosis and interested in improving lifestyle while exclusion criteria includes: diagnosed chronic disease or orthopaedic issues that would interfere with ability to participate in a physical activity program. Women will be randomized to either intervention (n=13) or usual care group (n=13). Intervention group will receive twice weekly session for 9 weeks and control group will receive recommendations about healthy lifestyle and usual care.

Discussion: This study attempts to improve the quality of life of symptomatic endometriosis women by reducing musculoskeletal and occupational impairments. Findings will offer a new therapeutic approach for a better pain control.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal status
* Clinical diagnosis of endometriosis by laparoscopy, magnetic resonance imaging or ultrasound imaging
* History of clinical symptoms
* To be able to walk without assistance
* To be able to read and write enough
* To be capable and willing to provide consent
* Interested in improving lifestyle

Exclusion Criteria:

* Acute or terminal illness
* Presence of any chronic disease or orthopedic issues that would interfere with ability to participate in a physical activity program
* Unwillingness to complete the study requirements
* Be registered in other exercise program
Automated Diabetes Registry Tools to Enhance Patient Self-Management and Provider Performance Feedback

Can we improve diabetes outcomes through 1) report card mailings to patients 2) point of care distribution of report cards to patients and 3) provider performance feedback with patient level data?

Our federally qualified health care center serves over 7000 diabetic patients, many of whom are uninsured (43%) or on medicaid (18%) or medicare (26%). The population is 54% Latino, 25% Caucasian, and 14% African American. We excluded patients older than 75; those without English or Spanish as a first language; and the homeless. The remaining 5457 patients were randomized to this one-year study which ended January 1, 2009. One-half of the enrolled patients received quarterly mailed report cards on their HgA1c, blood pressure, and lipid performance. They were asked to pick from a list of self-management goals and to see their provider if their last visit was more than 2 months prior to the mailing. In a 2x2 design, our eight clinics were randomized to i) on-site printing of patient report cards or no on-site printing and ii) standard provider performance report cards or enhanced provider report cards. The standard provider report cards included data on provider performance on HgA1c, LDL, and blood pressure compared to other providers. The enhanced provider report card also included a list of up to 10 patients not at HgA1c, LDL, or blood pressure goal. The provider report cards were distributed on a quarterly basis, and the point of care patient report cards were distributed at every clinic visit.

We are analyzing the impact of the intervention on the percent of patients at expert recommended goals for glycemic, lipid, and blood pressure control. We are also performing a qualitative analysis to describe provider and patient attitudes toward the interventions.

Eligibility Criteria:
Inclusion Criteria:

* icd9 code for diabetes
* primary care visit in the past 18 months
* English or Spanish as primary language

Exclusion Criteria:

* age more than 75
* No working address
Altered Faecal Protease Activity in Irritable Bowel Syndrome Patients in China

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder haracterised by abdominal pain or discomfort associated with altered bowel habits,while the mechanism is still not understood.Recent advances have conceptualized the faecal supernatants of diarrhoea-predominant IBS have a substantially higher serine protease activity, while in china,almost no studies have reported about protease activity in IBS.


Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling the Rome III criteria for IBS participated in the study -

Exclusion Criteria:

* Organic gastrointestinal disorders were excluded by detailed blood and stool analyses, serological assays and colonoscopy.
Natural History of Coronary Atherosclerosis

The present study sought to explore the predictive value of radial wall strain (RWS, derived solely from angiograms) for coronary artery lesion progression compared with lesion vulnerability assessed by optical coherence tomography (OCT). The lesion progression at 1 year was defined as an increase of ≥20% in diameter stenosis based on quantitative coronary angiography (QCA) evaluation.

The recently developed angiography-derived maximum RWS (RWSmax) was computed as the maximum deformation of lumen diameter throughout the cardiac cycle, expressed as a percentage of the largest lumen diameter. This approach offers a quantitative assessment of the biomechanical attributes of coronary lesions. Consequently, it allows for the identification of lesion vulnerability, potentially compensating for the limitations of intravascular imaging in assessing lesion stability and optimizing strategies for identifying high-risk vulnerable plaques in patients.

In the present multicenter, prospective cohort of individuals with acute myocardial infarction, we assessed the predictive significance of identifying vulnerable lesions using an RWSmax threshold of ≥13%. The investigation aimed to determine the capacity of these identified lesions to predict the progression of the disease at 1 year. Furthermore, the study validated that predictive capacity of RWSmax was on par with, and not inferior to, lesion vulnerability assessed by OCT in tracking lesion progression.

Eligibility Criteria:
Inclusion Criteria:

* General Inclusion Criteria:

  1. Age ≥18 years
  2. Acute myocardial infarction ≤ 45 days
  3. Planned coronary angiography examination or potential interventional treatment
* Angiographic Inclusion Criteria:

  1. The presence of at least 1 non-flow-restricting lesion (visually estimated diameter stenosis: 30%-80%; QFR \> 0.80) in any non-infarct related artery with RVD ≥2.5 mm by visual assessment

Exclusion Criteria:

* General exclusion Criteria:

  1. Cardiogenic shock
  2. Pregnant or woman of child-bearing potential
  3. Life expectancy less than 1 year for non-cardiac causes
  4. Unable to tolerate contrast agents or anticoagulant/antiplatelet therapy
  5. Prior CABG or planned CABG
* Angiographic exclusion Criteria:

  1. Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification, branch ostium cannot be shown clearly, severe overlap in the stenosed segment or severe tortuosity of any interrogated vessel deemed not amenable to QFR or RWS measurement
  2. An interrogated lesion require surgical bypass grafting
  3. Unable to judge culprit lesion or infarct-related artery according to current evidence
Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).

This study is a multicenter, randomized, modified-blind, double-dummy two-week parallel-group efficacy and safety study of arformoterol tartrate inhalation solution twice daily, tiotropium inhalation powder once daily and arformoterol tartrate inhalation solution twice daily and tiotropium inhalation powder once daily (dosed sequentially) in subjects with COPD. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects must be at least 45 years old at the time of consent.
* Subjects must have a pre-established primary clinical diagnosis of COPD.
* Subjects must have a baseline FEV1 of ≤65% of predicted normal value at Visit 1.
* Subjects must have a FEV1 ≥ 0.70L at Visit 1.

Exclusion Criteria:

* Subjects who do not have a FEV1/forced vital capacity (FVC) ratio of ≤70% at Visit 1.
* Subjects who do not have a ³15 pack-year smoking history and a baseline breathlessness severity grade of ³2 (Modified Medical Research Council \[MMRC\] Dyspnea Scale Score) at Visit 1.