cyrilzakka/clinical-trials huggingface dataset:
Impact of Acceptance and Commitment Therapy on Early Stage Breast Cancer

The purpose of this randomized controlled trial is to evaluate the effectiveness of an empirically supported psychosocial treatment, Acceptance and Commitment Therapy, in facilitating improved quality of life, benefit-finding, and cortisol rhythm in breast cancer patients in an outpatient clinical oncology setting.

Previous research indicates that breast cancer patients may demonstrate disrupted diurnal cortisol rhythms compared to healthy individuals, and that these disrupted rhythms may be related to recurrence and earlier mortality in some patients. Interestingly, improvements in cortisol regulation in previous intervention studies for cancer patients have not necessarily been related to decreased distress. Rather, improvements in post-traumatic growth, benefit-finding, and meaningfulness have also accounted for improved neuroendocrine and immunological changes.

Traditional breast cancer groups, however, may not adequately address these areas because existing interventions often target the reduction of distress as the primary vehicle to improve psychosocial, quality of life, and biophysical outcomes. Acceptance and Commitment Therapy (ACT) is an empirically-supported, mindfulness-based psychological treatment that has been shown to enhance meaningful behavior change thorough increasing emotional acceptance of difficult psychological experiences such as distress, without the goal of changing or eliminating them.

The current study seeks to determine the preliminary effect of an 8-week ACT group in increasing positive life changes and corresponding increase in salivary cortisol slope in 40 distressed breast cancer patients, who will be randomly assigned to ACT or a wait list control group.

The hypotheses for the present study include:

* Patients receiving ACT will demonstrate improvements in Quality of Life (QoL), Benefit-finding (BF), and health behavior compared to control group participants
* ACT participants will demonstrate improvements in mean cortisol levels and cortisol reactivity compared to control group participants
* These changes will be the result of increased mindful acceptance of cancer-related distress and meaningful behavior changes, rather than a reduction in distress.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of stage I-III breast cancer
* prescreen distress score above defined cutoff
* agreement not to seek other breast cancer support services until study completion

Exclusion Criteria:

* previous cancer
* prior psychiatric treatment for serious mental health disorder (e.g., hospitalization or formal diagnosis of psychosis, major depressive episode, borderline mental retardation, suicidality, or current substance dependence)
* current use of medications known to interfere with cortisol levels (e.g., dexamethasone)
* major concurrent medical disease
Influence of an Intervention on Diet, Physical Exercise and Mindfulness in the Quality of Life of Survivors With Breast Cancer

ABSTRACT

BACKGROUND:

Breast Cancer (BC) is one of the leading causes of death among women around the world. Integrative oncology, together with conventional medical treatment, has proven to be an important support for the control of cancer symptoms, improvement of quality of life, and contribution to the overall patient health, providing an integrated patient care both physically and emotionally.

METHODS:

75 stage II-III breast cancer survivors were randomized (according to age, tumor stage and receptor status) into 2 groups: intervention and control. Within the intervention group (IG) a diet, exercise and mindfulness intervention was performed, while the control group (CG) did not receive any sort of treatment, during 6 months. Passed (at the beginning and end of the research) questionnaires concerning general health, quality of life (EORTC QLQ-C30 and BR23), and diet (Mediterranean diet adherence test and 24-h-recall) and a blood and urine sample was collected to analyze general biochemical variables.

RESULTS:


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 70 years of age
* Breast cancer IIA-IIB operable in follow-up
* Seen in the Oncology service of the Virgen de las Nieves Hospital in Granada
* Residents in the city or metropolitan area of Granada
* Had completed, in the 12 months prior to its inclusion, treatment with surgery, radiotherapy and / or systemic chemotherapy treatment (including biological treatment).

Exclusion Criteria:

* Those who presented some physical or psychic limitation that prevented the intervention from being carried out were excluded from the study.
Prognostic Value of Echocardiographic Parameters Based on Machine Learning Approach

Transthyretin cardiac amyloidosis is an increasingly recognized cause of heart failure with preserved ejection fraction. Its diagnosis is currently based on a non-invasive method including biology and imaging. Still currently incurable, the evolution of this pathology is burdened by numerous comorbidities, including iterative hospitalizations for heart failure leading to death. The Machine Learning approach has already shown its efficiency in terms of diagnosis but its prognostic approach has not yet been studied.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspicion of transthyretin cardiac amyloidosis
* Age ≥18 years

Exclusion Criteria:

* Lack of data to confirm or overturn the transthyretin amyloidosis diagnostic
* Echocardiographic data not allowing deep analysis (technical default, bad echogenicity of the patient)
* Final diagnostic of AL or AA amyloidosis
Safety Evaluation of the LGL102 in Obese Subjects Treated With OMS102

The main objective of this study is to evaluate the LGL102 implant safety in obese to morbidly obese subjects treated with OMS102 system. The effect of the therapy on body weight changes will be also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 - 60 years old at time of screening
* BMI of 35 to 55 at time of screening
* History of obesity ≥ 5 years
* The subject has been under routine care of the investigator or another single physician that can supply a medical record for at least 6 months prior to enrollment
* Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
* No significant weight loss (\< 5%) within four months prior to enrollment as documented in the subject's medical record.
* Successful psychological evaluation following the institution psychological evaluation protocol for bariatric surgery or successful historic assessment performed no more than 6 months prior to enrollment.
* Glycosylated Hemoglobin; HbA1c ≤ 7.0 % at Visit 2 or historic value performed no more than 3 months prior to enrollment.
* If taking anti-depressant medications, they must be stable for at least six months prior to enrollment
* Willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of the trial
* Alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial
* Able to provide voluntary informed consent

Exclusion Criteria:

* Any prior bariatric surgery
* Other implanted electrical stimulation devices (e.g. pacemaker, defibrillator, neurostimulator)
* Diagnosed with past or current psychiatric condition that may impair his/her ability to comply with the study procedures
* Use of anti-psychotic medications
* Diagnosed with a eating disorder such as bulimia or binge eating
* Obesity due to an endocrinopathy (e.g. Cushing disease)
* Insulin therapy
* GI disease such as hiatal hernia (\> 5cm), gastroparesis, esophageal motility disorders or intractable constipation.
* Any history of peptic ulcer disease within 5 years prior to enrollment
* History of Barrett's esophagus
* Women who are pregnant, lactating or anticipate becoming pregnant within 24 months
* Arthritis or other pathologies limiting physical activities that physician feels should exclude the patient from the study.
* Cardiac history that physician feels should exclude the patient from the study.
* Use of another investigational device or agent in the 30 days prior to enrollment
* A history of life-threatening disease within 5 years prior to enrollment
* Any other condition that, in the opinion of the investigator, would make the subject unsuitable for the study
Comparison of Dry Needle and Massotherapy on Tolerance Effort and Soreness

Introduction: Delayed onset muscle soreness (DOMS) is a common myogenic condition considered to be a muscle tension injury frequently observed in recreational or experienced athletes, induced in the majority of cases by eccentric and inactive exercises, the most common of which are: tension, pain and impairment muscular and have a course of typical duration of 24 hours and peak between 48 and 72 hours. Among the treatments proposed with the aim of reducing the symptoms of DOMS is massage therapy. However, dry needling is a relatively new technique that has been used in myotendinous lesions and its effects on late muscle pain have not yet been studied. Objective: To compare the impact of dry needling and massage therapy on exercise tolerance, and analgesia of sedentary individuals with late muscle pain induced by eccentric exercise. The present study is characterized as a randomized and blinded comparative study in which male sedentary individuals will be invited in which the late muscle pain will be induced through eccentric contractions and will receive different treatments: dry needling or massage therapy. The upper limb functionality, pain perception, superficial hyperemia and brachial biceps thickness will be compared through the exams: visual analogue pain scale (VAS), digital algometry, thermography, ultrasonography and isometric test.


Eligibility Criteria:
Inclusion Criteria:

not practicing physical activity BMI greater than 18 and less than 30 members of the UFPE community

Exclusion Criteria:

making use of analgesic or anti-inflammatory medications acupuncture or dry needling or massage therapy in the last 6 months report of muscle pain orthopedic neurological problems hypertension and diabetes cardiovascular or respiratory diseases
Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection

An open label study will be performed on 80 people with HIV infection who are maintained on effective treatment with antiretroviral drugs.

The goal of this study is to test whether a bowel anti-inflammatory drug that is known to be safe and effective for inflammatory bowel disease would offer benefit in reducing the residual immune activation associated with treated HIV-1 infection. Specifically, the two immediate goals are to examine the safety of Pentasa® in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated HIV-1 infection.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18
* On ART for at least 1 year during which: viremia \<50 RNA copies/ml for at least 3 measurements (allowing for 1 nonconsecutive blip of \<100), and CD4 T cell count consistently \>500 during that time
* CD4 T cell nadir \>350
* Last CD4 and T cell test in past 6 months

Exclusion Criteria:

* Plans to modify antiretroviral therapy in the next 12 weeks for any reason
* History of inflammatory bowel disease or irritable bowel disease
* Chronic active hepatitis B or C
* History of autoimmune disease
* Hypersensitivity to any component of Pentasa
* Clostridium difficile infection
* Receiving rectally delivered medications
* Receiving anti-inflammatory medications (such as nonsteroidal anti- inflammatory drugs, steroids, or TNF inhibitors)
* Receiving immunosuppressive steroids
* Receiving any medications associated with bleeding risk
* Hemoglobin \< 10.0 g/dL
* Platelet count less than 100,000/mm3
* White blood cell count \< 2,000 cells/mm3 or \> 15,000 cells/mm3
* Symptoms of sexually transmitted infection
* Antibiotics used in the last 90 days
* Renal insufficiency with creatinine clearance less than 50 ml/min
* Elevated transaminases greater than 2.5 times the upper limit of normal
* Evidence of decompensated cirrhosis, heart failure
* Pregnant or breastfeeding women
Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions

This study involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function.

This study involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function. This is a 2-phase study designed to evaluate knee pain and function in healthy participants with a history of medial knee arthritis.

The purpose of this study is to evaluate: 1. how using the shoe device will affect a person's walking gait and balance over a single day; and 2. how using the shoe device over the course of a 12-week period will affect a person's walking gait and balance.

Eligibility Criteria:
Inclusion Criteria:

* Chronic, OA-related knee pain
* Diagnosis of medial compartment knee OA (unilateral or bilateral)
* Moderate pain of ≥4 out of 10 points while performing a weight-bearing activity
* Kellgren and Lawrence score of 2, 3, or 4 evidenced on routine, standard-of-care x-ray within the last 2 years prior to enrollment
* Able to walk unassisted for at least 10 minutes at a time
* Wear a Women's shoe size of 6.5 to 13 or a Men's shoe size of 5 to 12.

Exclusion Criteria:

* Patients suffering from acute septic or inflammatory arthritis
* Unstable cardiovascular, orthopaedic, or neurological conditions, uncontrolled diabetes, or any condition that would preclude exercise in moderate duration, moderate workload trials
* Received a corticosteroid injection or invasive procedures within prior 6 months of the study
* History of avascular necrosis in the knee
* History of knee buckling
* Joint replacement in any lower extremity joint that has not optimally recovered (e.g. still causes significant pain or affects mobility) as determined by the PI.
* Experienced more than 3 falls within the last year
* Currently using any knee brace on a regular basis for the knee pain, with the exception of basic knee sleeves
* Pathological osteoporotic fracture
* Severe symptomatic degenerative arthritis in lower limb joints other than the knees
* Severe back pain, prior spinal fusion or spinal deformity that would affect gait
* Major cardiac or pulmonary conditions and any orthopedic limitation that precludes their ability to independently walk for 10 minutes or longer
* Knee flexion contracture greater than 15°
* Knee flexion of less than 90°
* Any major injury to either knee within the prior 12 months
* Currently enrolled in a supervised physical therapy program
Evaluation of Different Diagnostic Methods of Tuberculosis in Assiut University Hospitals

* Detection of sensitivity and specificity of microscopic examination and Molecular studies using polymerase chain reaction (PCR) Mycobacterium tuberculosis (MTB)/ non tuberculous mycobacterium (NTM) MDR-TB compared to culture which is the gold standard technique in the diagnosis of TB to reach the most reliable one for better health care service.
* Assess the prevalence of tuberculosis cases among clinically suspected cases admitted to the hospital throughout the selected study period.

Tuberculosis (TB) is an infectious disease of global public health importance caused by the M. tuberculosis complex. Alarmingly, the disease has worsened with the emergence of multidrug-resistant strains of tuberculosis (MDR-TB).

Annually, it is estimated that approximately 450,000 new cases of MDR-TB occur according to a report from 2021.

There is an alarming increase in the global incidence rate of tuberculosis in the year 2021 after covid-19 pandemic, reversing the downward trend maintained in previous decades. In parallel, there is a rise in cases of drug-resistant tuberculosis.

Early diagnosis and appropriate treatment of tuberculosis are essential public health priorities. In this context, microbiology laboratories play a vital role in the rapid and accurate detection of tuberculosis and drug resistance.

Accurate and prompt diagnosis of TB is essential for the control and management of the disease, but there are numerous factors that affect the effectiveness of this process. These problems include the difficulty of correctly diagnosing latent and active forms of TB, the lack of precise protocols for different types of TB, and the difficulty of accessing diagnostic facilities in regions with limited resources.

Laboratory diagnosis of pulmonary tuberculosis is essential in combating the disease, with a significant role in patient management and isolation of contagious cases. In many developing countries with a high incidence of TB, advanced diagnostic methods and drug susceptibility testing are rarely available.

Given its substantial influence on global health, it is imperative that the investigators continue researching and developing innovative techniques and technologies to better the detection and treatment of tuberculosis.

In our study, the investigators try to compare between different available tests to diagnose TB for better treatment and health care service.

Eligibility Criteria:
Inclusion Criteria:

* Patients with signs and symptoms of tuberculosis (suspected cases)
* Patients diagnosed with tuberculosis.

Exclusion Criteria:

* Patients with pulmonary infections other than TB
A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System

The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.

The primary objective is to evaluate whether clinical opinion of product performance results in expected wound response and outcomes when using the Medela Invia Motion Endure NPWT system during 4-week study duration.

\* Goal of therapy will be defined by the physician according to initial assessment:

Endpoints (dependent on goal of therapy):

* Decrease in wound volume
* Decrease in size of the tunneling area
* Decrease in size of undermining
* Decrease in amount of slough
* Increase in granulation tissue
* Decrease in edema/periwound swelling
* The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft.

\*\*Study endpoint will be determined by physician at the time of enrollment, when the goal of therapy is documented\*\*

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects ≥18 years of age.
* Signed, informed consent by patient or LAR
* Patient is determined to be in need of NPWT for treatment of a diabetic foot ulcer, pressure injuries, and pressure ulcer, surgical wounds, acute/traumatic wounds and dehisced wounds, abscesses, or to prepare the wound bed for grafting or closure and/or to decrease edema
* Patient is comfortable (e.g. not in pain)
* Patient is willing and able to adhere to treatment protocol.

Exclusion Criteria:

* Patient not willing to comply with follow up (f/u) clinic visits
* Subjects with

  * Necrotic tissue with eschar present
  * Untreated osteomyelitis
  * Non-enteric and unexplored fistulas
  * Malignancy in wound
  * Exposed vasculature
  * Exposed nerves
  * Exposed anastomotic site of blood vessels or bypasses
  * Exposed organs
* Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
* Patients with concurrent conditions or co-morbidities that in the opinion of the investigator may compromise patient safety or study objectives
Potential Effects of Omega 3 Supplementation on Cardiomyocytes Membranes for Patients With Coronary Atherosclerosis?

To show the existence of a atrial cardiomyocytes membranes modification in omega-3 supplemented patients with coronary atherosclerosis.

Very few human data are currently available on the fatty acid composition of cardiomyocytes membranes. Preoperative omega-3 supplementation for patients undergoing cardiac surgery with cardiopulmonary bypass is correlated with a decreased frequency of postoperative complications in type of arrhythmia atrial fibrillation. Atrial fibrillation is the most common complication: 30 to 50% after myocardial revascularization. The occurrence of atrial fibrillation increases morbidity and mortality after surgery for sure. The pathophysiological mechanisms of common atrial fibrillation treated in heart rhythm units are different from those of postoperative atrial fibrillation. Indeed, atrial fibrillation is a common disease primarily of the left atrium, although atrial fibrillation after cardiac surgery is a multifactorial disease with implication of various pathogens such as inflammation without precise anatomical support. The preventive use of polyunsaturated fatty acids omega-3 long-chain (LC-AGPIω3), prior cardiac surgery is far from widespread due to a Lack of information dissemination, by insufficient number of published studies, despite the existence of a number of ongoing clinical trials and a complete ignorance of biological mechanisms of action. A human clinical study is needed. In a context of cardiac surgery with cardiopulmonary bypass and without deleterious side effects of preoperative enrichment in omega-3, it seems appropriate to conduct a feasibility study to provide information on structural changes in membranes of cardiomyocytes.

Eligibility Criteria:
Inclusion Criteria:

* Men without diabetes,
* over 50 years with overweight (BMI greater than 25) and
* without severe obesity (BMI less than 40)
* Patients who have given their written consent,
* the beneficiary of a social security system.
* Elective cardiac surgery with sternotomy and cardiopulmonary bypass for coronary artery bypass graft.

Exclusion Criteria:
Long-term Benefit of MPA in Liver Transplantation

MPA drugs are antiproliferative immunosuppressants and are widely used in solid organ transplantation. MPA drugs do not affect the recipient's kidney function and do not cause metabolic abnormalities and other problems. Intestinal solvent-based MPA drugs are widely used in clinical practice by improving the dosage form, reducing the irritation of MPA to the mucosa of the digestive tract, improving the tolerability of patients and maintaining a sufficient amount of MPA. However, data on the use/long-term use of intestinal solvent-based MPAs in liver transplant recipients are lacking. The study aims to evaluate the long-term benefits of enteric-coated mycophenolic acid in liver transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent their first liver transplantation between January 1, 2016 and February 28, 2021;
* Recipient's survival time≥ 1 year;
* Age 18\~65 years old;
* Patients with complete data and no loss to follow-up.

Exclusion Criteria:

* use of other types of anti-metabolic immunosuppressants;
* Second liver transplantation for various reasons within 1 year after the first transplantation;
* Patients with serious underlying diseases, including heart disease, infection and renal insufficiency, combined with other malignant tumors.