cyrilzakka/clinical-trials huggingface dataset:
Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure

Atrial fibrillation (AF) is the most common arrhythmia, which leads to reduced cardiac output and promotes the occurrence of heart failure, and abnormal hemodynamic changes in the left atrium induce thrombosis, which seriously reduces the quality of life, and even leads to death. For patients who need cardiac surgery combined with the Cox-Maze IV (CMIV) surgical ablation, oral amiodarone postoperatively for three consecutive months was recommended as the preferred treatment option. However, the study found there were still 15%-35% of patients at risk of AF recurrence. Dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, has been widely used for the treatment of type 2 diabetes mellitus and heart failure. Nonetheless, it remains unknown whether dapagliflozin can improve the recurrence of AF and reduces adverse cardiovascular events for patients who need CMIV ablation, and whether it can be routinely used for AF patients without diabetes or heart failure. Therefore, this study aims to explore the effect of postoperative oral dapagliflozin on the recurrence of AF after CMIV.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patients with persistent or long-term persistent atrial fibrillation who need isolated surgical Cox-Maze IV procedure
* Patients who need cardiac surgery combined with Cox-Maze IV procedure
* Patients who have the ability and willingness to abide by all the subsequent reviews and requirements
* Sign the informed consent

Exclusion Criteria:

* Dapagliflozin allergy
* Hyperthyroidism
* Patients with acute myocardial infarction, cerebral apoplexy, and other vascular diseases during the past 6 months
* Patients who received heart surgery within the last 3 months
* eGFR\<45ml/min
* History of oral SGLT2i
* Estimated survival period \< 12 months
* Pregnant and lactating women
* Left atrial diameter \> 65 mm
* Refusing to sign the informed consent
Vestibular and Multisensory Influence on Bodily and Spatial Representations

The present project aims at describing how vestibular signals contribute to the multisensory mechanisms of bodily self-consciousness.

There is a large body of data regarding the sensory and neural mechanisms of self-consciousness, but most studies have so far demonstrated the contribution of visual, tactile and proprioceptive signals to bodily self-consciousness. Thus, most studies have neglected the contribution of the vestibular system, a major sensory system for spatial and bodily representations. The vestibular system is sensitive to head motions in space and head inclinations with respect to gravity and it should therefore contribute significantly to several bodily experiences. This contribution should be put under neuroscientific scrutiny. We believe that the current neuroscientific models of bodily self-consciousness will be incomplete until they incorporate the contribution of vestibular signals.

The present project specifically aims at testing the hypothesis according to which vestibular signals significantly influence bodily self-consciousness, in particular first-person and third-person perspective taking and the internal body models (i.e. the body schema and body image). The present project also aims at describing how cortical vestibular processing is modified during experimental changes of perspective taking and viewpoint. In addition, the present project will describe whether vestibular disorders change performances in third-person perspective taking tasks and modify internal body models. This should help understanding bodily symptoms in vestibular-defective patients. To this end, we will combine approaches from psychophysics and electrophysiology (electromyography, electroencephalography) in healthy volunteers and behavioral approached in patients with vestibular disorders.

These studies should further the understanding of how the brain processes vestibular signals, which is to date poorly understood. In addition, the outcome of the present project should help understanding the multiple and complex symptoms reported by patients with vestibular diseases, and should therefore improve their treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient with chirurgical treatment for Meuniere disease or accoustic neurinoma or with acute vestibular deficiency.

Exclusion Criteria:

* Patient with neurological history
* Patient with a lack of motricity
The Effects of Eccentric-focused Exercise on Posterior Shoulder Tightness in Symptomatic Overhead Athletes

The aim of this study is to investigate the effects of shoulder eccentric exercise training on shoulder mobility, rotator cuff strength, pain and dysfunction, scapular kinematics and muscle activation in symptomatic overhead athletes with posterior shoulder tightness.

Overhead athletes commonly have posterior shoulder tightness due to repetitively high tensile loading during overhead throwing. However, intervention studies focused on posterior shoulder tightness in people with subacromial pain are still limited. Additionally, eccentric exercise was thought to improve the eccentric strength and neuromuscular control of posterior shoulder muscles to endure repetitively eccentric loading, which may improve posterior shoulder tightness and decrease the risk of subacromial pain. Nevertheless, no previous study investigated the influence of eccentric exercise on posterior shoulder tightness in overhead athletes. The aim of this study is to investigate the effects of shoulder eccentric exercise training on shoulder mobility, rotator cuff strength, pain and dysfunction, scapular kinematics and muscle activation in symptomatic overhead athletes with posterior shoulder tightness.

Eligibility Criteria:
Inclusion Criteria:

* Participate in overhead sports over 4 hours per week
* Age between 20 to 50 years old
* Glenohumeral joint range of motion deficit: Shoulder internal rotation loss more than 15 degrees compared to the non-dominant side and total arc of motion loss more than 5 degrees or/and horizontal adduction range of motion lo more than 15 degrees compared to the non-dominant side
* Shoulder impingement syndrome criteria

Exclusion Criteria:

* History of shoulder dislocation, fracture and operation
* History of direct contact in upper extremities or cervical region in the past one month
* Shoulder pain or neurological symptom caused by cervical problem
* VAS more than 5 during shoulder elevation
* Receive treatment for posterior shoulder tightness in the past 3 months
Written Exposure Therapy for Posttraumatic Stress Disorder

Although evidence-based treatments for PTSD exist, a significant minority of individuals do not benefit from these treatments and many individuals to not seek treatment, citing barriers such as time commitment and expense of treatment. The goal of the proposed study is to establish an alternative PTSD treatment that is efficacious and efficient.

Prior research has demonstrated that written exposure therapy (WET), is an efficient, well-tolerated, and efficacious treatment for PTSD. The proposed project takes the next step in establishing WET as an intervention for PTSD by examining whether WET is equally efficacious to an evidence-based treatment for PTSD. Using a randomized noninferiority controlled trial, 126 adults diagnosed with PTSD will be assigned to either WET or Cognitive Processing Therapy (CPT). Outcome data will be collected at baseline and 6-, 12-, 24-, 36- and 60-weeks post-first treatment session. The primary aim is to examine whether PTSD participants assigned to WET demonstrate PTSD symptom severity outcome that is noninferior to PTSD participants assigned to CPT. Secondary aims include examining whether expected treatment gains are sustained for both treatments and whether WET has a lower treatment dropout rate relative to CPT. Exploratory aims include examining moderators and mediators of WET and CPT. If the hypothesis that WET is noninferior to CPT is confirmed then a brief treatment option for PTSD will be established.

Eligibility Criteria:
Inclusion Criteria:

* PTSD diagnosis
* if taking psychotropic medication, on stable dose for 2 months
* Ability to read and write in English

Exclusion Criteria:

* not currently engaged in active PTSD treatment
* no current diagnosis of substance dependence
* no current diagnosis of psychosis
Randomized Study of Botulinum Toxin Type A for Achalasia

OBJECTIVES: I. Compare the efficacy of two doses of botulinum toxin in the treatment of achalasia.

II. Compare the safety of these two doses in these patients.

PROTOCOL OUTLINE: This is a randomized, double blind, dose response study. Patients are randomized to one of two treatment arms; each arm receives a different dose of botulinum toxin type A.

All patients undergo a flexible upper gastrointestinal endoscopy. Botulinum toxin is injected into the lower esophageal sphincter into each of 4 quadrants. Some patients may receive a second treatment, depending on response and/or time of relapse.

Patients are followed daily for 7 days, then every 1-6 months for 1-2 years after treatment.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of achalasia by esophageal manometry and upper endoscopy
* Symptomatic including dysphagia, regurgitation, etc.
* No esophageal ulcers, Barrett's esophagus, significant esophagitis, or esophageal varices

--Patient Characteristics--

* Hematopoietic: Platelet count at least 50,000/mm3
* Hepatic: PT no greater than 3 seconds No severe hepatic problems
* Renal: No severe renal problems
* Cardiovascular: No recent myocardial infarction No unstable angina No decompensated congestive heart failure
* Pulmonary: No severe pulmonary disease with dyspnea at rest
* Other: No altered mental status No serious systemic disease Not pregnant
SEntine Lymph Node in earLY Ovarian Cancer (SELLY)

The present study aims at investigating the feasibility, the detection rate and the negative predictive value of sentinel node in predicting the presence or absence of lymph node metastasis in ovarian cancer patients

Patients with early stage ovarian cancer have a good prognosis. However, nearly 15% of the initially diagnosed as early stage ovarian cancers, will be upstaged after an appropriate surgical staging due to lymphatic metastasis, despite of preoperative radiological data. Therefore, complete pelvic and para-aortic lymphadenectomy in these patients represents a crucial procedure. On the other hand, nodal dissection may be associated with threatening intra- and post-operative complications.

If feasible and accurate, the sentinel lymph node procedure could be a modality to avoid unnecessary radical lymphadenectomy without missing important information on nodal status.

With the present study we aim at exploring the role of sentinel node dissection in early ovarian cancer patients.

Patients with ovarian cancer macroscopically limited to the ovary (early ovarian cancer) will receive injection of a tracer (patent blue or indocyanine green) which have already been proven safe and extremely effective in several other gynecologic and non-gynecologic malignancies. Then the retroperitoneal spaces will be opened as for a standard lymphadenectomy procedure and the lymph node marked with the tracer will be identified. After dissection of the sentinel node, lymphadenectomy will be completed according to current guidelines.

Operative data, pathological findings and accuracy of sentinel node in predicting nodal status will be registered.

Eligibility Criteria:
Inclusion Criteria:

* Epithelial ovarian cancer
* Early stage disease limited to the ovary

Exclusion Criteria:

* Evidence of extraovarian disease
* Allergy to the materials used
Added Value of PET/CT in Lung Cancer

Assess the value of PET/CT in the diagnosis, staging, response evaluation, and relapse monitoring of lung cancer.

Lung cancer is a leading cause of cancer-related mortality worldwide, accounted for 1.80 million deaths in 2020.(1)Egyptian statistics showed that lung cancer in men represents 8.2% of among all cancers of men according to the Egyptian National Cancer Program in 2014 (3).Epidemiological data indicate that the main risk factor for the development of lung cancer is cigarette smoking.(4)Lung cancer is histologically divided into: Non-small-cell lung cancer (NSCLC), which accounts for 85% of cases and Small cell lung cancer (SCLC).(5)Due to absence of screening, most patients with lung cancer are not diagnosed until later stages, when the prognosis is poor.(6)Radiologic manifestations of bronchogenic carcinoma include obstructive pneumonitis or atelectasis, lung nodule or mass, apical mass, cavitated mass, or nodule or mass associated with lymphadenopathy(6)Conventional chest radiography, computed tomography (CT), magnetic resonance imaging, radionuclide scintigraphy, and positron emission tomography (PET) all have been used for NSCLC staging.(7)PET/CT is a well-established radiological modality with high diagnostic accuracy in metastases detection compared to usual CT. Also, it has been reported that up to 10% of patients with bronchogenic carcinoma are found to have metastases on PET/CT that were not detected on CT with subsequent different patients' staging. The high accuracy of PET/CT in tumor staging makes it important for the treatment strategy of either surgical treatment, radiotherapy, or chemotherapy. Also, it becomes essential during the follow-up to detect recurrence. PET/CT shows a higher ability to evaluate the early response to the treatment as chemotherapy by its ability to detect the metabolic response even before the size change.(8)The prognosis of lung tumors depends on early and accurate staging as well as the histopathological type of the primary tumor, with the squamous cell carcinoma type regarded to be of a worse prognosis than that of adenocarcinoma.(9)

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven lung cancer patients.

Exclusion Criteria:

* Patients with second malignancy.
* Severely ill patient (patient with disturbed consciousness level, or couldn't lie during the imaging).
* Uncontrolled diabetic patient with blood glucose level more than 200mg\\dl.
* Pregnant women.
* Patient age \<18 years.
Drug-coated Balloon Therapy for In-stent Restenosis and de Novo Coronary Lesions

This was a single-center, prospective, open-label, observational study. Patients with coronary artery disease confirmed by coronary angiography and treated with drug-coated balloon catheter alone for target vessels were enrolled in the Cardiology Department of our hospital in January 2022. The primary endpoint was late lumen loss within 12±3 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥18 years with coronary heart disease;
2. If the target lesion stenosis ≥70% is complicated with angina pectoris or evidence of myocardial ischemia, DCB should be administered;
3. Residual lumen diameter stenosis ≤30% after lesion pretreatment and DCB, no vessel dissection, or type A or B dissection, and TIMI blood flow level 3;
4. Target lesions were treated with DCB for the first time.

Exclusion Criteria:

1. Intraoperative implantation of salvage stent in DCB;
2. Acute myocardial infarction occurred within 1 week after DCB operation;
3. Less than 3 months of dual antiplatelet therapy after DCB operation, or more than 1 month of discontinuation of antiplatelet therapy;
4. The position of the stent could not be determined by coronary angiography.
5. Desmovascular disease or left main artery disease;
6. Atrial fibrillation;
7. Patients with severe heart failure, valvular heart disease, renal insufficiency, severe infection and autoimmune disease.
Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children

Subjects aged 1-8 years who have been discharged from the emergency department/outpatient care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates during the 21-day follow-up period.

Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and peak flow rates.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 1-8 years old
* Discharge from emergency department/outpatient clinic with a diagnosis of asthma exacerbation after usual standard care
* Subjects must be able to show efficient use with a jet nebulizer

Exclusion Criteria:

* Subjects requiring hospitalization
* Subjects receiving oral steroids 1 week prior to presentation to emergency department.
* Subjects with FEV1 \< 50% of predicted
* Subjects with co-morbid medical conditions (renal or cardiovascular disease)
* Subjects with reported history of HIV
* Subjects unable to follow up for study visits
* Subjects who are frequently enuretic
Immediate Function of NobelSpeedy Shorty and Brånemark System® Mk III Shorty Implants in Daily Use

The aim of this study was to evaluate the 7 mm long implants NobelSpeedy Shorty and Brånemark System Mk III Shorty: by determining the marginal bone remodeling, implant survival rate, soft tissue health and maintenance.

The primary endpoint was the change in marginal bone levels (in mm) from the time of implant insertion to follow-up visits (3, 6, 12, 36 and 60 months).

Further endpoints were:

* cumulative survival rates of the implants
* soft tissue parameters (papilla index, bleeding on probing)
* plaque formation

Eligibility Criteria:
Inclusion Criteria:

* The subjects should have an osseous architecture enough to receive an implant with a diameter of at least 3.75 mm for Brånemark System Mk III Shorty or 4 mm for NobelSpeedy Shorty and a sufficient amount of bone for placing implants with a length of 7 mm.
* The final tightening torque at installation should be 35-45 Ncm without further rotation and should not exceed 45 Ncm.
* The subject as well as the implant site(s) should fulfill criteria for immediate provizionalization.
* Immediate insertion (e.g. placement of the implant immediately after extraction) will not constitute an exclusion criterion.
* The implants site(s) should be free from extraction remnants.
* The subject should be healthy and compliant with good oral hygiene.
* The subject should be available for the 5-year term of the investigation.
* Favorable and stable occlusal relationship

Exclusion Criteria:

* Alcohol or drug abuse as noted in patient records or in patient history.
* Health conditions, which do not permit the surgical procedure.
* Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in patient records or in patient history.
* The subject is not able to give her/his informed consent to participate.
* Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation.
* Severe bruxism or other destructive habits.
PAIN Empathy Assessment in Sleep Deprived Emergency & Acute Care Clinicians

Cognitive Empathy is relevant in clinical practice and will be assessed based on the accuracy of pain recognition and the pain intensity evaluation in a computerised task using facial expressions. Repeated measures across day and night shifts will provide the basis to understand the impact of shift work on those abilities in health care professionals.

Assessment and management of the pain patients experience is one of the key skills needed in the field of anesthesiology. The consideration of non-verbal cues is essential, especially the recognition of facial expressions. The human ability to recognize emotions in others depends on the capacity for empathy of an individual, specifically cognitive empathy. In the clinical context empathy is understood as a set of skills and competences rather than a character trait. It may therefore vary due to various parameters. Currently there is no research available on the influence of shift work on the human ability to recognize pain in facial expressions. However, work schedules that do not fit the natural circadian rhythm are known to alter the processing of emotions. In particular the ability to judge the intensity of an emotion is influenced. Therefore, the hypothesis of the present study will be, that shift work impairs the pain assessment performance of an individual. To test this hypothesis, the effect of shift work on the performance in recognizing and assessing pain intensity of faces by health care professionals in the anesthesia department will be assessed. A repeated measures assessment will be used.

Eligibility Criteria:
Exclusion criteria:

* refuse to participate
* not working night shifts
* no patient contact

Inclusion criteria:

* working day and night shifts
* health care professional with patient contact
The Change Cycle Intervention for Improving Quality of Life in Breast Cancer Survivors

This study is proposed to assess long-term Quality of Life issues in breast cancer survivors by measuring the impact on the quality of life made by the structured "Change Cycle Work Shop" coping class as compared to current local standard of care programs. It has been shown that breast cancer treatment can have long-term bio-psychosocial consequences. Specific evidence-based interventions are needed to address Quality of Life concerns in order to improve the overall outcome of breast cancer and its treatment beyond the focus on mortality rate.

Breast cancer is the most common cancer among North American women. A combination of screening mammography and improvements in treatment has resulted in a substantial decrease in mortality which explains why more women diagnosed at a younger age are becoming long-term survivors.Consequently, quality of life (QL) issues have become increasingly important in the contemporary multidisciplinary management of breast cancer. Standard of car survivorship program has evolved over several years to include 3 facets: (1)clinical surveillance program to include routine follow up exams; (2) local support group programs; and (3) rehabilitation program offering physical and occupational rehab, along with lymphedema prevention and treatment.

Many studies have reported on successful interventions (listed in our references) with improvements in quality of life; however the effects did not last long after intervention. This has brought into question the real value of such interventions. The proposed class will focus on teaching life skills that have shown long-lasting effect in the corporate world of change. Thus, our goal is to determine if the impact of the class will be similar in the healthcare arena, specifically cancer survivorship. Our last study on assessing quality of life revealed that patients were suffering deficits in quality of life, specifically with regard to the emotional scale despite the standard of care approach available. We therefore propose this intervention to be studied as proof of concept so that depending on the results of the proposed trial, this class can become a routine part of the survivorship program.

Eligibility Criteria:
Inclusion Criteria:

* female
* 18 years old or older
* established diagnosis of breast cancer
* diagnosis from January 2010 onward
* must be patient of Texas Tech University Health Sciences Center-Breast Center of Excellence
* must agree to participate in study structure of randomization

Exclusion Criteria:

* those who do not accept randomization
* women with medical conditions that preclude them from attending the coping class
* women with personal issues that preclude them from attending the coping class