cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Cholecystectomy Care Protocol

The purpose of this study is to determine compliance with the Prisma Health-Upstate Laparoscopic Cholecystectomy Perioperative Protocol.

Evidence based medicine calls for the application of scientific advances to clinical care. In an effort to address the most common complications of a surgical procedure, perioperative protocols have recently been created in an effort to apply best practices consistently and enhance the recovery from surgery. In addition to evaluating the validity of the protocol components themselves, it is valuable to measure compliance with said protocol. Failure to complete the steps of a care pathway may be caused by several reasons, and a study of application of these steps may help future efforts at standardization of care.

The purpose of this study is to determine compliance with the Prisma Health-Upstate Laparoscopic Cholecystectomy Perioperative Protocol.

Hospital inpatient data from patient charts, office charts, and hospital medical data systems of Prisma Health-Upstate System will be used to review the records of all patients age 18-75 years, inpatient and outpatient, who had surgery for choledocolithiasis between January 1, 2016 to April 1, 2017.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 years and 75 years who had surgery for choledocholithiasis at Prisma Health-Upstate.

Exclusion Criteria:

* Patients under 18 years of age and older than 75 years of age.
Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 10 mg in Japanese Healthy Male Adult Subjects

Researchers in this study wanted to compare the effect of the formulation (orally disintegrating tablet and film-coated tablet) on the bioequivalence of drug Rivaroxaban (brand name: Xarelto) at dose of 10 mg in Japanese healthy male subjects aged 20 to 40 years. Rivaroxaban is an approved drug to be used for the prevention of events/diseases caused by blood clots. Currently, there are two formulations of Rivaroxaban available on the market in Japan and they are film-coated tablets and fine granules. To further improve patients' convenience, a new formulation, orally disintegrating tablet (ODT, a drug dosage form designed to be dissolved on the tongue rather than swallowed whole) is under development. The goal of this study was to compare the effect of this new formulation with film-coated tablets when taken with or without water.

Participants in this study received one oral dose of rivaroxaban 10 mg ODT either with or without water and one oral dose of rivaroxaban 10 mg film-tablet. There were at least 5 days between the two doses. Observation for each participant lasted about 6 weeks in total. Blood samples were collected from the participants to measure the blood level of the study drug.


Eligibility Criteria:
Inclusion Criteria:

- Japanese healthy male subjects, aged 20 to 40 years (inclusive), with body mass index 17.6 to 26.4 kg/m²

Exclusion Criteria:

* Subject with incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study drugs will not be normal
* Subject with known hypersensitivity to the study drugs (active substances or excipients of the preparations)
* Subject with known coagulation disorders (e.g. von Willebrand disease, hemophilia)
* Subject with febrile illness within 1 week before the first study drug administration
* Subject with suspicion of drug or alcohol abuse
* Subject with intake of foods or beverages containing grapefruit, pomelo, Seville orange, and tangelo within 1 week before the first study drug administration
* Subject with therapies (e.g. physiotherapy, acupuncture, etc.) within 1 month before starting study treatment
* Subject with clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree atrioventricular block, prolongation of the QRS complex over 120 msec or of the corrected QT (QTc) interval over 450 msec
* Subject with systolic blood pressure below 90 or above 130 mmHg
* Subject with diastolic blood pressure below 45 or above 85 mmHg
* Subject with clinically relevant deviations of the screened laboratory parameters from reference ranges
Comparative Effect of Neck Isometrics and Deep Cervical Flexion Exercises on Neck Pain Among Breastfeeding Females.

Neck pain is a common complaint among breastfeeding females, potentially attributed to sustained postures and muscle imbalance. Breastfeeding females experiencing neck pain, aged between 18-40 years, will be recruited through local healthcare facilities and community outreach. The physical demands of breastfeeding, such as prolonged postures and repetitive movements, can contribute to the development of musculoskeletal issues in the cervical region.

Despite the prevalence of neck discomfort among breastfeeding females, there is a paucity of research exploring effective exercise interventions tailored to this specific population. Mothers' awareness of proper nursing positions during breastfeeding may have positive impact on the connection between mother and baby. Most typical positions for nursing a baby are cross cradle hold, cradle hold, side lying and football hold. Most common adapted breastfeeding position is cross cradle.

A randomized control trial will be conducted to assess and compare the effectiveness of neck isometrics and deep cervical flexion exercises in alleviating neck pain, reducing disability, improving range of motion, and addressing muscle weakness in breastfeeding females. A sample size of 48 lactating women will be taken. Data will be collected from private clinical setups of Bahawalpur by using (NPRS) Numeric Pain Rating Scale Questionnaire, (NDI) Neck Disability Index, Range of motion will be assessed by inclinometer and Muscle strength will be assessed by MMT. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups of equal members. Group A will be given Neck Isometric Exercises and Conservative treatment for 30 min (3-4days/week) of duration for total 6 weeks.

Group B will be given Deep Cervical Flexion Exercises with conservative treatment. The interventions will be provided for 30 minutes for 3-4 Day/week for 6 weeks. All participants in both groups will be evaluated before and after the treatment programs. Outcome measures will be calculated after 6 weeks of intervention. Data will be analyzed by using SPSS 21

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 25 to 40 years
* Mode of delivery (vaginal/c-section)
* Severe neck weakness (above grade III)
* Primigravida

Exclusion Criteria:

* Previous history of upper extremity musculoskeletal symptoms
* Radicular neck pain
* History of inflammatory disease (myelopathy)
* History of cervical fracture
Visual Pain Score and Perfusion Index in Postoperative Patients

The relationship between visual pain score and perfusion index in postoperative patients.

The patients' operated with general anesthesia and who had visual pain score(VAS) above 3 will be measured postoperatively perfusion index. .If the VAS score is above 3, 2 mg of morphine will be made. When the VAS score is below 3, the perfusion index will be measured again.Thus, the changes between vas and perfusion index will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent surgery with general anesthesia

Exclusion Criteria:

* Patients with caesarean section, pregnancy story and chronic pain
The Correlation Between Sleep Quality and Atrial Fibrillation Undergoing High-flow Nasal Cannula Oxygen (HFNC)

The investigators hypothesized that heated humidified high-flow nasal cannula oxygen(HFNC) along with high quality of sleep, in comparison with noninvasive positive pressure ventilation (NIV), could reduce the release of inflammatory marker C-reactive protein(CRP), which as independent predictor of atrial fibrillation（AF）, further lower the incidence of new-onset AF following coronary artery bypass grafting(CABG).

Atrial fibrillation (AF) has been reported to occur in up to 20-40% of patients undergoing coronary artery bypass grafting (CABG). Postoperative AF plays a major role in the determination of hemodynamic deterioration and can be associated with thromboembolic stroke. Aside from the risk factors of age, pain, cardiac dysfunction and hypokalemia, hypoxemia is also considered to be the major contributor to AF initiation and persistence. Aiming to the common postoperative complications, noninvasive positive pressure ventilation (NIV) provides an available modality to improve the oxygen and even obviate the reintubation.

However, some patients are contraindications for NIV, with Loss of consciousness, hemodynamic instability, and some are intolerance due to dryness, gastric distension, skin breakdown and noise, with complaints of insomnia and sleep disturbance. The aforementioned factors largely limits its use. Recently, the heated humidified high-flow nasal cannula (HFNC), free of psychic stress and physical discomfort, shows a favorable compliance and tolerance in treating the hypoxemic patients. As a result, in this comfortable setting we predict a high sleep quality in HFNC oxygen therapy. Evidence has suggested that sleep abnormalities trigger the cascaded release of C-reactive protein (CRP). As is well known that CRP is involved in atrial structural remodeling and asynchronous conduction, which attribute to the initiation and maintenance of AF.

Therefore, in this present study, the investigators first evaluate the sleep quality (architecture and duration) by the polysomnographic (PSG) monitoring after coronary surgery. Based on the sleep parameters, the investigators hypothesize that HFNC, along with high quality of sleep, in comparison with NIV, could reduce the release of C-reactive protein, which as independent predictor of atrial fibrillation (AF), further lower the incidence of new-onset AF following CABG.

Eligibility Criteria:
Inclusion criteria:

Hypoxemic respiratory failure

Exclusion criteria:

Cardiac or respiratory arrest
The Experiences of Patients With Greater Trochanteric Pain Syndrome.

Greater Trochanteric Pain syndrome (GTPS) is a debilitating condition causing pain on the outside of the hip. This study aims to explore the experiences, beliefs and expectations of patients with GTPS, using semi-structured interviews.

Greater Trochanteric Pain syndrome (GTPS) is a debilitating condition causing pain on the outside of the hip. There is growing evidence to suggest that psychological barriers to recovery are present in patients with peripheral pain. The experiences and beliefs of patients suffering with GTPS are unknown. This study aims to explore the experiences, beliefs and expectations of patients with GTPS, using semi-structured interviews to inform the development of interventions for evaluation in future research.

Eligibility Criteria:
Inclusion Criteria:

* Adults \> 16
* Able to speak and understand the English language
* Patients seen in a Specialist Consultant lead clinic who have been given the diagnosis of lateral hip pain, Greater Trochanteric Pain Syndrome (GTPS), Trochanteric Bursitis or Gluteal Tendinopathy.

Exclusion Criteria:

* Inflammatory conditions
* Systemic / Infective disease
* Previous diagnosis of Fibromyalgia or persistent multi-joint pain.
Atrial Fibrillation Duration and Cortical Lens Opacity

The prevalence of atrial fibrillation (AF) and the risk of stroke increase with a higher CHA2DS2-VASc score. Osmotic stress, which also contributes to cortical cataract formation, increases in the presence of diseases that raise the CHA2DS2-VASc score. Knowledge of AF duration is crucial because it heightens the risk of AF-related complications. This study investigated whether the presence of cortical cataracts, classified using the Lens Opacity Classification System (LOCS)stage, can predict the presence and duration of AF.

Atrial fibrillation (AF) is the most common type of heart rhythm disorder encountered in clinical settings and is associated with increased morbidity and mortality. The prevalence of AF and the risk of stroke increase with higher CHA2DS2-VASc scores . Cortical cataracts develop at the periphery of the lens and progress toward the center in a spoke-like pattern. The incidences of AF and cortical cataracts significantly increase with age .

Similar to subclinical AF, the initial onset of AF may go undetected, and the time required for AF to become permanent varies. Longer episodes of AF and higher CHA2DS2-VASc scores are strongly associated with an increased annual risk of stroke or systemic embolism , making it essential to estimate the duration of AF.

Cortical cataract stages can be easily identified and monitored through simple biomicroscopic examination. To our knowledge, no reliable method currently exists to predict the duration of AF of unknown onset. This study investigated the relationship between cortical cataract stages and the presence and duration of AF by analyzing p.osmolarity data and comparing it with the LAVI.

Eligibility Criteria:
Inclusion Criteria:

Atrial Fibrillation patients

Exclusion Criteria:

Advanced HF (New York Heart Association class 4), Decompensated HF Prior cataract surgery Diabetic ketoacidosis Alcohol use Severe hyponatremia \[sodium level of \&lt; 125 mEq/L\], Nephrotic syndrome Cirrhosis Hypothyroidism
Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a Registered Trademark of the GSK Group of Companies.

This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in combination with insulin in improving the control of blood sugar when compared with taking insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both AVANDIA and metformin are medicines which are individually licensed for the treatment of type II diabetes mellitus. Because they act in different ways, it is thought that combining them may give an increased benefit of treating diabetes and reducing blood sugar.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have been diagnosed with type II diabetes mellitus and not have adequate glycaemic controlled while receiving at least 1.5g of metformin.
* Patients must have a body mass index of greater than 25 kg/m2 and must not suffer from ankle swelling.

Exclusion Criteria:

* Patients cannot have any form of congestive heart failure or severe or unstable angina.
* Patients cannot be currently receiving insulin, but be prepared to begin insulin treatment.
Reducing G60 Recidivism Rates

The research surrounding best practice guidelines of geriatric trauma patients in the inpatient setting is broad. Furthermore, the comprehensiveness of research programs varies based on individual hospital resource capacity. American College of Surgeons Trauma Quality Improvement Program (ACS TQIP) Geriatric Trauma Management Guidelines1 details a comprehensive, multidisciplinary approach to inpatient management; however, guideline effectiveness is diminished as many hospitals may implement a version of the guidelines limited by staffing, ancillary services, and resource capacity, among other variables.

Risk of future falls in elderly patients increases based on multiple factors including increased age and history of previous falls. However, there is limited research showing evidenced-based interventions that reduce recidivism rates related to falls. The Centers for Disease Control and Prevention (CDC) has an evidenced-based fall prevention program (Stopping Elderly Accidents, Deaths \& Injuries \[STEADI3\]). Implementation of STEADI as part of a multidisciplinary approach to fall risk assessment and prevention prior to discharge may reduce recidivism in elderly patients.

Ground level falls are the most common mechanism of injury in older adults and are increasingly becoming a significant cause of morbidity and mortality in this population. An individual's risk of a repeat ground level fall increases after an initial fall, injury, or hospitalization7. Addressing fall risk factors and tailoring inpatient care for any trauma in the elderly population prior to discharge will likely improve outcomes, decrease length of stay, and decrease morbidity and mortality.

The introduction of STEADI as part of a specialized multidisciplinary approach to fall risk assessment and prevention prior to hospital discharge may reduce recidivism in elderly patients. Patients that attend the discharge class are typically more likely to go home and return to independence whereas those that do not attend the discharge class are likely to have a disposition of going to a long-term care facility or are not mentally capable of retaining information. Reduced falls as a result of STEADI implementation will putatively improve mortality rates and quality of life in elderly patients.

Eligibility Criteria:
Inclusion Criteria:

* 60 years or older
* G60 activation and admission
* Primary admission for injury

Exclusion Criteria:

* Less than 60 years old
* Admitted for non-traumatic injuries
* Non-index admission for injury
* Prisoners
* Pregnant or lactating subjects
BFR After Bicep Tenodesis

A randomized controlled pilot study evaluating the effect of occlusion training on bone density and function of the upper extremity following a biceps tenodesis.

Blood flow restriction training, resistance exercise performed with a specialized venous tourniquet, leads to beneficial changes in muscle strength at low resistance and minimal stress on the nearby joint. Early research further indicates that it improves systemic bone mineral density with change in bone turnover markers. This novel resistance training has the potential to improve muscle strength and bone density in individuals who are medically unable to perform high resistance exercises typically required to improve these attributes. Our study will examine the effect of occlusion training on bone density and function of the upper extremity following a bicep tenodesis. The primary objective of the intervention is to achieve improved bone density and accelerated recovery of upper extremity function as assessed using measures such as validated questionnaires, functional outcome testing, strength testing, and dual energy x-ray absorptiometry.

Eligibility Criteria:
Inclusion Criteria:

* Selected to undergo a unilateral bicep tenodesis
* Males and females age 18-65
* DoD beneficiaries
* Must be able to read and write in English in order to consent

Exclusion Criteria:

* Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 1/10.
* Rehabilitation protocol with prohibited muscle strengthening greater than 6 weeks post-operation.
* Current metallic implants that contraindicate or significantly affect the sensitivity of DEXA scan
* Current implanted defibrillator or pacemaker
* Pregnancy - per patient self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, these patients will not be included in this study.
* Recent history of deep vein thrombosis within the 12 months or on active treatment with anticoagulants
* Currently taking medications that are known to affect bone density to include heparin, warfarin, glucocorticoids, medroxyprogesterone acetate, cancer treatment medications, bisphosphonates or other osteoporosis treatment medications, and thyroid hormone.
* History of hyperparathyroidism
* History of upper quadrant lymph node dissection
* Patient endorsement of easy bruising
* History of an upper extremity amputation
* Active infection in the operative extremity
* Cancer (current diagnosis per medical record)
The Relationship Between Magnetic Resonance Imaging (MRI) Scores and Sensory Testing in Axial Spondyloarthritis

Axial spondyloarthritis is one of the most common rheumatic diseases and chronic pain and morning stiffness are the main complaints of these patients. Central sensitization is defined as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with many rheumatological diseases has been demonstrated in several studies. There is no method for the diagnosis of central sensitization is accepted as a gold standard. The clinical scales and quantitative sensory testing (QST) widely is used for this purpose widely. The most commonly used QST types include pressure pain threshold (PPT), temporal summation (TS) and conditioned pain modulation (CPM). The well-known scale used for the evaluation of central sensitization is the Central Sensitization Inventory (CSI) , developed in 2011 for detect central sensitization in chronic pain patients. In this study, it was aimed to investigate the relationship between QST and CSI and sacroiliac MRI changes.

Central sensitization is hypersensitivity and increased response to normal/painless stimuli due to dysfunction in endogenous pain pathways. Quantitative sensory testing is frequently used to detect pain sensitization, and pressure pain threshold (PPT) and temporal summation (TS) are often preferred for this purpose. Recently, in addition to these methods, conditional pain modulation (CPM), in which descending pain pathways are tested, is also preferred. With PPT and TS measurement, local/generalized sensitivity increase can be detected in patients who develop pain sensitization. Observation of increased nociceptor response and decrease in pressure pain threshold in the tissue damaged area is interpreted in favor of peripheral sensitization, while obtaining a similar response in adjacent or distant areas is defined as generalized increased sensitivity. Although it is known that local hyperalgesia is one of the main findings of inflammation, studies that have shown this quantitatively are limited. Inflammatory lesions are observed in patients with axial spondyloarthritis, especially in the active stages of the disease, and the relationship of these lesions with PPT, TS and CPM values and pain sensitization is unknown. Therefore, in this study, it was planned to investigate the relationship of inflammatory and structural lesions detected by sacroiliac MRI with regional PPT,TS, CPM and pain sensitization in patients diagnosed with axSpA.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with axSpA according to the Assessment of SpondyloArthritis International Society (ASAS) criteria
* Aged between 18-65 years

Exclusion Criteria:

* Had an other rheumatic diseases, peripheral vascular disease, peripheral neuropathy and spine disease (e.g., symptomatic herniated disc, spinal stenosis),
* Using centrally acting pain medications (e.g., pregabaline, duloxetine, opioids) or glucocorticoids (\>10 mg prednisone or its equivalent) within 3 months of study enrollment