cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effects of Treatments Applied to Patients With Facial Myalgia on Occlusion Parameters

The temporomandibular joint (TMJ) is closely related to neuromuscular components. A problem occurring in any of these components or parts of the TMJ interferes with the harmonic functioning of the TMJ and invites temporomandibular joint disorders (TMD).Management of TMD can be conservative or surgical. Physiotherapy, local steam application, external muscle massage, occlusal adjustment, analgesic and physiotherapeutic medication and splint treatments are the most frequently recommended conservative treatments. Today, occlusal adjustments are made with the help of a prosthetic or orthodontic appliance. With these intraorally used occlusal splints, a balanced occlusal contact is achieved without applying any force to the mandible in the resting position. Occlusal splints are available in different designs and different construction materials. The stabilization splint, which is one of the most frequently used occlusal splints, and the modified Hawley splint are appliances produced from hard materials. However, some researchers have commented that soft splints produced from resilient materials may also be useful in the distribution of excessive force formed in parafunctional habits. While there are studies stating that hard splints provide more successful results than soft splints in functional problems of the chewing system, there are also studies reporting that they have similar efficacy on muscle pain after short-term use. However, there are no studies in the literature that compare their efficacy in short-term and long-term myalgia patients and demonstrate their efficacy using an objective test such as digital occlusion analysis. There was no study on the effectiveness of different splints on the patient's quality of life. It would be appropriate to carry out our study to fill this gap in the literature.The main purpose of this study is to digitally examine and compare the effects of three different treatment methods (medical therapy, medical therapy+soft splint, medical therapy +hard splint) applied to patients diagnosed with facial myalgia after temporomandibular joint examination on the existing occlusion changes.


Eligibility Criteria:
Inclusion Criteria:

* No systemic disease that may have effects on masticatory muscles or TMJ
* Individuals who do not have any tooth loss other than molar teeth and accept the treatments to be performed.

Exclusion Criteria:

* Individuals with total or partial prosthesis with distal extension
* Individuals who have previously received medical, pharmacological or any type of treatment for TMD
* Individuals who have recently been exposed to facial or cervical trauma
* Individuals with the syndrome who have the potential to affect any component of the stomatognathic system
* Individuals with parafunctional habits such as clenching or grinding their teeth.
Silent Brain Infarction After Endovascular Arch Procedures

This is the largest study to evaluate incidence and distribution of silent cerebral infarction (SBI) following endovascular repair for disease of the aortic arch. Also, it is the first cohort to include total endovascular arch repair and devices flushed with carbon dioxide (CO2) to prevent gaseous cerebral embolization.

Introduction. Poor data exist concerning the rate of silent cerebral ischemic events following endovascular treatment of the aortic arch. The objective of this work was to quantify these lesions using the STEP registry.

Methods. This multicentre retrospective cohort study included consecutive patients treated with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted magnetic resonance imaging (DW-MRI) within 7 days after the procedure. DW-MRI was performed to identify the location and number of new silent brain infarctions (SBI), microbleeds ans general outcome of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Included patients underwent a proximal endograft deployment in Ishimaru zone 0 to 3

Exclusion Criteria:

* Missing preoperative computed tomography angiography (CTA) scan of the chest and any circumstances that precluded the DW-MRI to be performed in the appropriate time window, such as a medical condition or an MRI contraindication
Calorie Restriction Diets on Weight Reduction, Post weigh-in Recovery and Exercise Performance in Athletes

Low-carbohydrate diets are often used as weight-loss strategies by obese individuals and athletes. This diet has effects on oxidizing fat and suppressing appetite. But short term evidences are still few. In combat sports such as taekwondo, athletes prefer rapid weight loss to achieve a desired weight category. The purpose of this study was to investigate the impact of the low carbohydrate diet combined with strict calorie restriction on body composition and exercise performance in taekwondo athletes.

This study used a randomized cross-over design. Each participant completed a low carbohydrate and a high carbohydrate trial in a random order, separated by a 30-day wash-out period. Each trial comprised of a 7-day weight loss period, followed by an 18-hr recovery period. The purpose of this study was to investigate the effect of 7-day caloric restriction with low- or high-carbohydrate diet, combined with an 18-hr recovery period, on body weight loss and taekwondo-specific performance.

Eligibility Criteria:
Inclusion Criteria:

* Must have at least 6 years of Taekwondo training experience
* Must have participated in domestic or international competitions

Exclusion Criteria:

* Smoking
* Cardiovascular disease
* Diabetes
* Hypertension
* Any medication in the past 3 months
The Effect of Neuropathic Pain in Patients With Combat-related Extremity Injury

It has been suggested that veterans with chronic pain might be at increased risk for the development of depression, anxiety and post-traumatic stress disorder. To date, most of the published studies have focused on chronic pain as a whole, and there are limited studies examining association of neuropathic pain with psychological comorbidity and quality of life.Combat related extremity injury significantly influences the patients' quality of life and psychological state. In this context, the purpose of this study is to illustrate to what extent neuropathic pain influences the quality of life, depression level and sleep quality of patients with combat-related extremity injury.

A total of 120 patients with combat-related extremity injury and 60 age and BMI-matched healthy controls will be participated in this cross-sectional study. The presence of neuropathic pain will be evaluated using Leeds assessment of neuropathic symptoms and signs (LANSS) questionnaire. The impact of pain on health-related quality of life will be assessed using the 36-Item Short Form Survey (SF-36). Beck Depression Scale (BDS) will be used to evaluate depression status of the patients. Quality of sleep will be assessed using the Pittsburgh Sleep Quality Index (PSQI).

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18-65 years who had previous history of combat-related extremity injury

Exclusion Criteria:

* Previous history of the cervical or lumbosacral radiculopathy, any known rheumatic disease or neurologic or endocrine disorders, excessive alcohol consumption and vitamin B12 deficiency
Effect of Meal Composition and Timing Modification on Glucose Metabolism, Body Temperature and Sleep

The purpose of our study is to understand the impact of different meal timing alterations on blood sugars, metabolism, microbiome and sleep physiology in people with prediabetes and diabetes; and to study the temperature/heart rate response to different meals in different people.

Pilot data points to an effect of the time between waking up and first meal is important in blood glucose management through the rest of the day. The investigators are interested in understanding the effect of caloric distribution through the day, specifically consuming more later in the day versus earlier in the day. The investigators want to test the hypothesis that consolidating the meals during a shorter span in the day (time restricted eating) can ameliorate blood sugars and sleep parameters in the studied population. The researchers would also like to compare dynamic range of meal-induced sympathetic responses (e.g. temperature and heart rate changes) between different metabolic health conditions (e.g. insulin sensitive vs insulin resistant vs diabetes) while controlling for dietary intake. Previous research studies suggest that people with different metabolic health conditions would have different meal-induced sympathetic responses. Based on this, the primary goal of the study is to characterize metabolic health based on non-invasive wearable sensor data that measure these responses.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older;
* Not be pregnant, if female;
* Be generally healthy (with no apparent symptoms at the time of enrollment)
* Patients with prediabetes or diet- controlled or type 2 diabetes or controlled with metformin, will also be allowed to participate.
* Be willing to provide written informed consent for all study procedures.

Exclusion Criteria:

* major organ disease
* pregnant/lactating
* diabetes medications except for metformin
* malabsorptive disorders like celiac sprue
* heavy alcohol use
* use of weight loss medications or specific diets
* weight change \>2 Kg in the last month
* history of bariatric surgery
* Any medical condition that physicians believe would interfere with study participation or evaluation of results
* Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol.
Exercise and Weight Loss in PAD

This study is designed to examine the added benefits of weight loss to an exercise program in older obese Veterans with peripheral arterial disease. The investigators want to determine if weight loss in addition to exercise will 1) improve walking ability to a greater extent than exercise alone and 2) determine the underlying reasons why walking ability improves by measuring blood flow and the amount of muscle in the leg muscles.

Peripheral artery disease (PAD) affects an estimated 12 -15 million adults in the US and an estimated 20% of older Veterans. Those with PAD ambulate with slow gait and experience decreased leg strength, dysmobility, reduced quality of life, serious morbidity and often premature death. It is estimated that over 60% of individuals with PAD are overweight or obese. While PAD itself worsens mobility, obesity adds a further functional burden to older adults with PAD. Individuals diagnosed with PAD, who are also obese typically claudicate 40% more quickly than non-obese individuals and take 20% longer to recover after claudication. Studies of older obese adults without PAD have demonstrated that the combination of exercise and weight loss is more effective at improving physical function and body composition than exercise alone. While these findings likely translate to older adults with PAD, this hypothesis has yet to be tested. This study is designed to determine whether weight loss and exercise (WL+EX) versus exercise ( EX ) alone will 1) improve mobility function (walking ability) to a greater extent than exercise alone and 2) determine the mechanisms underlying changes in mobility function by measuring muscle microvascular perfusion and composition. The investigators hypothesize that a combined intervention of weight loss and exercise (aerobic and restive) will result in greater improvements in mobility function through improved muscle perfusion and reduced muscle fat infiltration than exercise alone in obese Veterans with PAD.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>25 kg/m2
* Ankle Brachial Index (ABI) \<.90
* Able to participate in a supervised exercise program at the Baltimore VA
* No current plan for surgical revascularization
* Claudication or leg symptoms when walking

Exclusion Criteria:

* Unstable angina or a recent heart attack
* Active cancer
* Dementia
* Current foot or leg ulcers
* Already exercise 2x/week or more.
Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery

The study will test the hypothesis that inflammatory markers measured at 24 hours after breast cancer surgery will be lower in patients receiving PECS II and PIFB blocks, supplemented with dexmetomidine compared to standard care group.

Breast cancer is a devastating disease. Surgery is the mainstay of treatment which can lead to ongoing patient difficulties. Severe acute pain after surgery is one of major risk factors for developing persistent postsurgical pain. Subsequent physiological stress caused by this severe pain may negatively influence the immune response leading to a worse prognosis.

Regional anesthesia is very effective in management of peri- and postoperative pain. Epidural block, paravertebral block and intercostal nerve blocks have been proven over time to be effective in preventing postoperative pain. However, their widespread use has been hampered by technical difficulty and inherent risks.

Unlike the aforementioned blocks, novel thoracic wall blocks, namely modified pectoralis block (PECS II) and pecto-intercostal fascial block (PIFB) are safe, simple and effective.

Efforts to prolong and improve analgesia following single shot blocks has led to the introduction of adjuvants into the local anesthetic. Dexmetomidine is a superselective Alpha 2 agonist with a proven ability to prolong the duration of neuraxial, peripheral nerve and interfascial plane blocks.

Chronic inflammation is recognized as a risk factor for initiation, progression and further spread of malignant growth. Surgical insult leads to inflammatory response which facilitates the development of a metastatic disease. Many inflammatory markers were proven to be independent prognostic factors in breast cancer patients.

The investigators propose to study the impact of novel thoracic wall blocks with dexmetomidine on simple inflammatory markers obtained from full blood count (NLR, PLR, NPR, PDW, MPV, RDW) after breast cancer surgery.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with ductal carcinoma (stage 1 to 3) undergoing primary potentially curative unilateral mastectomy.
* Older than 18 years
* ASA I-III

Exclusion Criteria:

* Weight \< 50 kg
* BMI \> 35
* Allergy to local anaesthetic or dexmetomidine
* Contraindications to NSAIDs use
* Local infection over block site
* Coagulopathy
* Preexisting chronic pain
* Pregnancy
* Autoimmune disease
* Inability to give informed consent
The Serum Sclerostin Levels in Cholesteatoma Patients

The aim of this study is to investigate the levels of sclerostin in patients with cholesteatoma. So far, there is no study showing the levels of sclerostin in cholesteatoma. The investigators hope that the results of our study will start new processes that can be used in the clinic.

Chronic otitis media (COM) is the perforation of the eardrum and mucosal inflammation of the space in the middle ear and the air cavities of the temporal bone over a period of three months. Although COM is defined as a multifactorial disease, its etiopathogenesis has not been fully elucidated. Cholesteatoma is a condition that disrupts the balance between bone formation and resorption in COM. The cholesteatoma is a destructive squamous epithelial lesion of temporal bone, it gradually expands and leads to serious complications by the destruction of near bone structures, ossicular chain and otic capsule. A growing debate examines the role of bone formation and destruction with osteoblasts, osteocytes and osteoclast cells in cholesteatoma formation. Sclerostin is a glycoprotein that plays a role in the regulation of bone metabolism secreted by osteocytes. Antibodies directed against sclerostin stimulate bone formation and represent a new therapeutic option for the treatment of increased bone resorption diseases, such as osteoporosis and generalized bone loss, inflammatory diseases with cartilage damage. The aim of this study is to investigate the levels of sclerostin in patients with cholesteatoma. So far, there is no study showing the levels of sclerostin in cholesteatoma. The investigators hope that the results of our study will start new processes that can be used in the clinic.

Eligibility Criteria:
Inclusion Criteria:

cholesteatoma chronic otitis media

Exclusion Criteria:

Acute infection Malignancy
Phase 2 Study of EPI-743 for Treatment of Rett Syndrome

Rett syndrome is a severe neurodevelopmental disorder that primarily affects female children. Rett syndrome is characterized by significant elevation in blood markers of oxidative stress. EPI-743 is a novel therapeutic with demonstrated efficacy and safety in the treatment of disorders characterized by oxidative stress. The purpose of this study is to examine the safety and efficacy of EPI-743 in a population of children with Rett syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Rett syndrome with disease stage 1-2
* Abnormality of at least two disease biomarker levels
* Confirmed MeCP2 mutation
* Patient or patient's guardian able to consent and comply with protocol requirements
* Abstention from use of Coenzyme Q10, vitamin E and Idebenone two weeks prior to enrollment into the study

Exclusion Criteria:

* Any condition, which in the opinion of the investigator could compromise the subject's safety or adherence to treatment with EPI-743.
* Clinically significant allergy or hypersensitivity to EPI-743 or to any of the excipients of with EPI-743 (eg., sesame oil).
* Clinically significant allergy or hypersensitivity to Vitamin E
* Lack of confirmation of MeCP2 mutation
* Clinical history of bleeding or abnormal baseline PT/PTT
* Diagnosis of any other concurrent inborn error of metabolism
* Hepatic insufficiency with LFTs greater than 3 times upper limit of normal
* Renal insufficiency requiring dialysis
* End stage cardiac failure
* Fat malabsorption syndromes precluding drug absorption
Adjunctive Oral Hygiene Aids in Reducing Oral Hygiene Parameters Among Orthodontic Patients

Adult orthodontic patients aged 18-30 were included in a randomised, singleblind clinical research using a split-mouth design at a dental clinic. Both theWaterflosser® and the Super-Floss® water flossers are manufactured by Oral-B.

In order to reduce gingival inflammation and remove subgingival plaque, oral hygiene therapy is necessary. The available evidence indicates that mechanical plaque control, which patients administer themselves daily, is the most important factor in managing and reducing plaque accumulation. Aim: This research aimed to determine whether Waterflosser or Superfloss was more effective in lowering the gingival bleeding score and plaque. Methods: Adult orthodontic patients aged 18-30 were included in a randomised, single-blind clinical research using a split-mouth design at a dental clinic. Both the Waterflosser® and the Super-Floss® water flossers are manufactured by Oral- B.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18-35 years undergoing orthodontic treatment and
* systemically healthy without habits

Exclusion Criteria:

* Participants not undergoing orthodontic treatment and participants undergoing orthodontic treatment in the included age category but with systemic conditions prevalent
* missing teeth and
* treated previously for periodontal conditions
Effect of Intravitreal Bevacizumab on Early Post-Vitrectomy Hemorrhage in Diabetic Patients

The purpose of this study is to determine whether bevacizumab 1-2 weeks before vitrectomy is effective in lowering the rate of early post-vitrectomy vitreous hemorrhage in diabetic patients.

Diabetes is the leading cause of blindness in the age range of 20-64 years. Pars plana vitrectomy may be indicated for the management of advanced proliferative diabetic retinopathy. Early post-vitrectomy hemorrhage in diabetic patients is relatively common; it occurs in 29% -75% of patients in the first month after surgery. This may cause delayed visual rehabilitation and detection of surgical complications such as retinal break or detachment. Preliminary reports such as case series reported by Spaide RF, et al showed beneficial effect of bevacizumab in proliferative diabetic retinopathy complicated by vitreous hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

* All eyes who are candidate for pars plana vitrectomy because of complications of diabetic retinopathy such as nonclearing vitreous hemorrhage, tractional retinal detachment threatening macula, active progressive PDR

Exclusion Criteria:

* One eye patient
* Best corrected visual acuity better than 20/50
* Pregnancy
* Use of internal tamponade such as silicone oil during surgery
* Concurrent ophthalmic surgery such as cataract extraction
Accuracy of CGM in the ICU, Compared to Standard of Care

To determine the performance of the Dexcom CGM device in comparison to arterial glucose samples.

The performance of the Dexcom continuous glucose sensor will be compared with the current standard of care which is arterial glucose samples analyzed on a glucose meter. Subjects will be ICU patients receiving intravenous insulin infusions.

Eligibility Criteria:
Inclusion Criteria:

* minimum age 18 years
* anticipated to be on an insulin infusion for 3-7 consecutive days
* 10 of these subjects will be on vasopressors who will be receiving large volume fluid resuscitation

Exclusion Criteria:

* subjects not on insulin infusion
Natural History of Coronary Heart Disease

To examine the natural history of mortality due to coronary heart disease in post-myocardial infarction patients from the Beta-Blocker Heart Attack Trial (BHAT) and the Aspirin Myocardial Infarction Study (AMIS).

BACKGROUND:

In January 1990, the National Heart, Lung, and Blood Institute issued a Program Announcement establishing a Small Grants Program to provide limited support to extend analyses of research data generated by clinical trials, population research, and demonstration and education studies. This study used data collected in two completed clinical trials, the BHAT and AMIS.

DESIGN NARRATIVE:

Study endpoints included all-cause mortality, cause-specific mortality such as sudden death, recurrent and non-fatal myocardial infarction, and incident congestive heart failure. Univariate and multivariate analyses of baseline data variables from BHAT were conducted to determine which were predictive of study endpoints. Baseline variables included sociodemograhic characteristics, medical history, medication use, physical examination finds, and electrocardiographic characteristics. Baseline characteristics found to be predictive of study endpoints in the BHAT placebo group were examined in the AMIS placebo group. Long- and short-term prognoses for patients suffering a transmural myocardial infarction were compared for those suffering a subendocardial infarction.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria