cyrilzakka/clinical-trials huggingface dataset:
The Effect of Exercise on Myokine Production in Aging Persons

The incidence of age-related diseases, such as cancer and cardiovascular diseases, rapidly rises. These days, age-related diseases cause the majority of all healthcare expenses. During ageing senescent cells secrete a range of harmful inflammatory signals, which leads to chronic inflammation (inflamm-aging) and accelerates aging throughout the rest of the body. Interestingly, people who regularly exercise show less signs of inflamm-aging compared to people with a sedentary lifestyle. Molecules secreted by skeletal muscles, called myokines, may play an important role. However, the underlying molecular mechanisms remain unknown. This pilot study aims to investigate if an acute bout of resistance training is an appropriate tool to induce an increase in the release of muscle derived myokines in aged persons.


Eligibility Criteria:
Inclusion Criteria:

* Healthy persons

Exclusion Criteria:

* Smoking
* Infection \< 2 weeks ago
* Received a vaccine \< 2 weeks ago
* Allergy to Lidocain
* Immune deficiency
* Presence of a tumour or in treatment
* Usage of anti-coagulant medication
* Presence of following conditions:

  * Haemophilia
  * Auto-immune disease
  * Cardiovascular disease
  * Musculoskeletal diseases which refrains the patient from exercising
Development of a Personalised Care Plan Designed to Reduce Chronic Post-Operative Pain Following Breast Surgery

Numerous surveys have shown that following breast surgery, longterm pain affects around half of patients. Given that 1 in 9 women will get breast cancer and that surgery is the cornerstone of treatment, persistent pain represents a major challenge. In addition to the suffering chronic pain causes to individual patients, the investigators know that it places a substantial burden on families and carers, and that patients with pain represent an excessive demand on healthcare resources.

This research will evaluate the impact of introducing a proactive, integrated care plan for patients having breast surgery. It will assess the effect of the care plan on reducing the number of patients with pain at 3 and 12 months after their procedure.

The personalised plan involves numerous evidence based steps linked by a single unifying description aimed at controlling pain, before, during and after the procedure, in hospital and at home.

Patients at risk of developing pain will be identified prior to the procedure and randomly allocated to follow either the personalised care plan or to receive 'usual' care. In the personalised care plan group, participants will get information about chronic pain, be screened for pain and offered immediate treatment. During their procedure both the surgeon and the anaesthetist will offer treatments such as nerve numbing procedures that reduce the likelihood of experiencing pain.

After their procedure, patients will be again screened for pain and further treatment instigated. Physiotherapists and other allied health professionals such as psychologists will also be involved as appropriate. A package of care for pain will then be passed on to the patients' GP, in the form of a written pain management plan, for ongoing care which will be linked to the hospital. Patients from both groups will be followed up for a year at regular intervals.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 and over with breast cancer undergoing breast surgery at the Royal Marsden Hospital. This includes mastectomy, wide local excision with axillary clearance, breast reconstruction surgery i.e Diep flap, LD flap

Exclusion Criteria:

* Previous thoracic surgery.
* Symptomatic angina pectoris.
* Renal impairment.
* Inability to read or to understand consent documentation.
* Patients undergoing the following surgery; lumpectomy, wide local excision, cosmetic procedures, any day-case breast surgery.
Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone at night before surgery in preventing PONV after elective laparoscopic cholecystectomy.

Background:

Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone 12 hours before induction of anesthesia in preventing PONV after elective laparoscopic cholecystectomy, as it reaches its peak effect at 2-12 hours and lasts for 72 hours after oral administration.

Methods:

This is a parallel, two-arm, randomized (1:1), controlled, single-center non-inferiority trial. Adults (≥18 years) with ASA physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The participants will be randomized to receive either 8 mg of IV Dexamethasone at the time of induction of anesthesia or 8 mg of oral Dexamethasone 12 hours before induction of anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 814 patients are intended to be recruited for this non-inferiority trial.

Discussion:

The current randomized trial is exploring the non-inferiority and feasibility of oral dexamethasone at night to reduce the PONV after laparoscopic cholecystectomy when compared to the standard of care - intravenous dexamethasone at the time of induction. Additionally, the investigators suppose oral dexamethasone at night is easier to administer, avoids polypharmacy at the time of induction of anesthesia, avoids the unpleasant sensation of intravenous injection, and is at a lower cost for a one-day surgery.

Eligibility Criteria:
Inclusion Criteria:

* all consecutive adults (older than 18 years) with ASA physical status I-III undergoing elective laparoscopic cholecystectomy surgery.

Exclusion Criteria:

* steroids or antiemetics within 1 week of surgery
* chronic opioid therapy
* history of allergy to any of the study drug
* serum creatinine \> 1.4 mg/dl
* liver enzymes \> triple the normal limits
* pregnancy
* patient refusal
* and psychiatric or neurologic diseases or socioeconomic status that would hinder the postoperative quality of recovery questionnaire
* laparoscopic surgery is converted to open surgery after enrollment
Secondary Prevention of Stroke Through Non-drug Therapeutic Weight Reduction

SCENARIO is a trial to investigate the role of non-drug weight reduction in secondary prevention of stroke. It is a single-blinded, randomized, controlled multicentre trial with two arms. The therapy arm is participating in a comprehensive weight reducing program, whereas the control group takes part in a lecture on healthy nutrition. The primary study objective is to assess the efficacy of non-drug therapeutic weight reduction in the secondary prevention of stroke. Secondary objectives are functional outcome, cognitive status, post stroke depression, and health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ischemic stroke
* Age: 20 - 85 years
* BMI ≥ 25.0 kg/m² or waist circumference in men ≥ 94cm and in women ≥ 80cm
* Functional impairment, which would allow to participate in weight reduction program (mRS 0-4, NIHSS 0-12)
* Patient must be capable of understanding informed consent
* Written informed consent for participation in the study

Exclusion Criteria:

* Intracerebral hemorrhage as primary cause of stroke (secondary hemorrhage is not an exclusion criterion)
* Speech disturbance (aphasia or sever dysarthria)
* Dimming of consciousness
* Stroke due to arterial dissection or coagulation disorder
* Drug-related weight changes during previous 3 months
* Changes in appetite influencing medication listed in appendix during previous 3 months
* Bariatric surgery in the past
* Diabetes mellitus with a history of severe ketoacidosis
* Pregnancy or nursing
* Severe co-morbid disorders, e.g.:

  * AV-Block ≥ 2nd degree
  * Heart insufficiency (NYHA \> 2)
  * Pericarditis, pericardial effusion
  * Severe kidney insufficiency (Creatinine \> 3 mg/dl; Urea \> 150 mg/dl)
  * Hepatic insufficiency (GOT \> 3 x ULN; GPT \> 3 x ULN)
  * Severe psychiatric disease within the last six months (psychosis, suicide attempts)
  * Chronic alcohol addiction or drug addiction
  * HIV- or hepatitis infection
  * Bleeding peptic ulcer (unless there is radiological evidence of healing 6 months prior to start of obesity program)
* Cognitive impairment with MMSE \< 20
* Depression with BDI \> 20
* Patients who are unable to give consent to study participation (MMSE \< 20, aphasia)
* Recurrent stroke or myocardial infarction in the period between screening for study participation and start of weight reduction program
* Simultaneous participation in another clinical trial
Risk Assessment of Endometrial Hyperplasia and Endometrial Cancer

Abnormal uterine bleeding (AUB) represents common diagnostic challenge in everyday gynecological practice. However, abnormal bleeding is a common symptom of many benign diseases and only indicates the presence of EC in 9% of postmenopausal women and 1% to 2% of premenopausal women, suggesting that many women at low risk undergo unnecessary invasive procedures to rule out cancer. The aim of the study is to create a risk-scoring model of endometrial hyperplasia and endometrial cancer.

Approximately 90% of endometrial cancer (EC) cases are preceded by AUB in premenopausal or perimenopausal women or post-menopausal bleeding (PMB).Transvaginal ultrasonography(TVS) has become the first step diagnostic tool of AUB. The main advantage of ultrasound imaging is that it has high accuracy for the preoperative classiﬁcation of intra and extra uterine lesions, both benign and malignant. If increased endometrial thickness (ET) is found in women with PMB, the risk of EC increases. However, in women with type II EC, ET below 3-4 mm might also be found. Because of these limitations, ET should not be the only factor for cancer risk estimation in women with AUB.

Three-dimensional sonography and blood ﬂow vascular indices improve the diagnostic precision of the sonographic estimation of endometrial lesions. Several scoring systems using different ultrasound image characteristics were proposed to estimate the risk of EC in women with AUB including the recently proposed system" Risk of Endometrial Cancer scoring model "(REC).

Existing guidelines recommend considering clinical risk factors such as BMI, age, obesity, type II diabetes, polycystic ovary syndrome(PCOS) and use of unopposed estrogen when evaluating AUB. However, only few clinical risk prediction models have been developed.

Despite the important role of ultrasound imaging in assessment of endometrial lesions, one wonders if clinical variables can improve the diagnostic performance of risk prediction models.

The aim of the study is to create a risk-scoring model of endometrial hyperplasia and endometrial cancer using patient clinical characteristics and ultrasound image characteristics among women with abnormal uterine bleeding, and to validate the diagnostic performance of our model and to compare it's predictive value with the recently proposed REC score for EC risk stratiﬁcation.

Eligibility Criteria:
Inclusion Criteria:

women ≥40 years with pre- or perimenopausal AUB or PMB presenting to Women's Health Hospital, Department of Obstetrics and Gynecology, Faculty of medicine, Assiut University, Assiut, Egypt.

Exclusion Criteria:

* Women with a vaginal bleeding arising from a cervical, vaginal or vulvar disease.
* Patients with cervical cancer or uterine metastases.
* History of prior hysterectomy, prior pelvic radiation, endometrial sampling within the past 3 months.
* Presence of existing pregnancy.
* Women with inadequate endometrial sampling or with no histopathological diagnosis.
The Effect of Arrhythmia Surgery on Quality of Life in Patients With Atrial Fibrillation Undergoing Cardiac Surgery

Atrial fibrillation (AF) is connected with an increased morbidity and mortality. In addition, quality of life is diminished due to palpitations, dyspnea, dizziness and syncope. AF is frequently associated with valvular and coronary disease. In the AF patients undergoing valvular or coronary surgery the arrhythmia almost always relapses. For symptom control anti-arrhythmic drugs and cardioversion are used but breakthrough arrhythmias and side effects of the drugs happen frequently. For more effective symptom control "add-on" arrhythmia surgery is being advocated. However, at present the investigators do not know whether add-on arrhythmia surgery indeed affects morbidity and quality of life.

The hypothesis being studied is that add-on arrhythmia surgery in patients with AF undergoing valvular or coronary surgery improves quality of life, establishes chronic sinus rhythm and reduces perioperative and long-term morbidity associated with AF.

Multicentre prospective parallel randomised controlled trial. In total 150 patients with documented atrial fibrillation (chronic and paroxysmal), were randomly assigned by a central computer system to undergo cardiac surgery with add-on surgery or without. This assignment was blinded to patients and all medical personnel except for the surgical team during total follow up. Patients completed quality of life questionnaires, comprising the RAND 36-item Health Survey 1.0 (SF-36), Multidimensional Fatigue Inventory-20 (MFI-20) and EuroQoL (EQ-5D and VAS) at baseline and 3, 6 and 12 months following operation.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergo valvular surgery and/ or coronary surgery,
* All patients have documented chronic atrial fibrillation of paroxysmal atrial fibrillation.
* Patients have given written informed consent.

Exclusion Criteria:

* Patients who do not speak Dutch or can not read Dutch.
* Patients with a Sick Sinus Syndrome.
* Patients with contraindications for oral anticoagulant agents.
* Incompetent to act for oneself
Telemonitoring After Surgery to Preserve Limb Function in Optimizing Mobility in Cancer Survivors With Skeletal Metastases

This randomized pilot trial studies telemonitoring after surgery to preserve limb function in optimizing mobility in cancer survivors with cancer spread to the bone. The use of mobile devices for telemonitoring may improve the delivery of cost-effective, high-quality, standardized surveillance of cancer survivors.

PRIMARY OBJECTIVES:

I. To develop and evaluate the feasibility of a method that enhances surveillance in cancer survivors by using mobile devices in addition to face-to-face visits following surgery for bone metastases.

SECONDARY OBJECTIVES:

I. To evaluate how well the face-to-face follow-up format can be adapted to using mobile devices for remote surveillance.

II. Limited efficacy testing of the remote surveillance program. III. To obtain information on acceptability of the mobile surveillance format by patients and clinicians.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (CONTROL): Patients undergo standard face-to-face follow up visits at 2, 6, 12, and 24 weeks after surgery. Patients also undergo a physical activity assessment over 15 minutes.

GROUP II (MOBILE SURVEILLANCE): Patients undergo standard face-to-face follow up visits as in Group I. Patients also undergo mobile surveillance comprising use of a mobile device application to send photos and videos to study staff and engage in video conferences at 3, 7, 13, and 25 weeks after surgery.

After completion of study, patients are followed up at 24-25 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Have been scheduled for an intramedullary nailing (IM) surgery with the department of Orthopaedic Oncology at University of Texas (UT) MD Anderson Cancer Center
* Are able to read and write English 3) Are 18 years or older
* Are willing and able to use a smartphone or tablet comfortably
* Have access to mobile hot spot, wireless internet, and/or cellular service
* Must have a caregiver or assistance at home who can assist with collecting physical therapy (PT) measures

Exclusion:

N/A
Safety & Efficacy of Extended Longevity Protocol

The purpose of this study is to quantifiably determine if the Extended Longevity Protocol has a significant clinical effect on epigenetic age.

This is a prospective non-randomized clinical study of 15 patients to determine if the safety and effectiveness of the Extended Longevity Protocol's impact on the nine determinant factors of aging can decelerate aging.

There is evidence that the Extended Longevity Protocol decelerates aging and the risk of age-related diseases. The aim of this pilot study is to evaluate the safety, efficacy and feasibility of the Extended Longevity Protocol as an effective treatment option to improve clinical care of healthy individual's biological age thus prolonging longevity.

Eligibility Criteria:
Inclusion Criteria:

* 8 Men and 7 Women
* Must between 55-75 years old
* Patient must be able to comply with treatment plan and laboratory tests
* Patients must have adequate immune system function, with no known immunodeficiency disease

Exclusion Criteria:

* Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
* No immune system issues or immunodeficiency disease
* No history of viral illness which could be reactivated by immune downregulation
* Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke) disease
* Diagnosis of a transient ischemic attack in the 6 months prior to screening
* Patients infected with hepatitis, C or HIV
* Patients with Body Mass Index (BMI) \> 40 kg/m2
* Presence of active infection
* Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study
* Unable or unwilling to provide required blood sample for testing
Efficacy of Zoledronic Acid in Osteoporosis

There has been no comparative data between Zoledronic acid and Zoledronic acid combined with active vitamin D in primary and secondary osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Osteoporotic patients who want to take zoledronic acid

Exclusion Criteria:

* Patients who are allergic to zoledronic acid or vitamin D
* Patients who are pregnant or breast-feeding
* Patients who have not taken zoledronic acid for the last 2 years
Acupuncture in Acute Nonspecific Low Back Pain

Acute low back pain is a common disorder in general practice. Some general practitioners (GPs) treat acute low back pain (LBP) with acupuncture, despite lacking evidence of its effectiveness for this condition.

The aim of this study is to evaluate whether a single treatment-session with acupuncture can reduce time to recovery when applied in addition to standard LBP-treatment according to the Norwegian national guidelines. Analyses of prognostic factors for recovery and cost-effectiveness will also be carried out.

The investigators hypotheses are:

1. Acupuncture treatment contributes to faster pain-recovery in acute LBP compared to standard treatment in general practice provided in accordance with the Norwegian national guidelines.
2. Acupuncture treatment for acute LBP improves function, and reduces drug use and sick leave, compared to the standard treatment in general practice provided in accordance with national guidelines.
3. Acupuncture treatment for acute LBP is a cost-effective treatment in general practice.

The investigators intend to include a total of 270 patients, 135 in the intervention group and 135 in the control group.

The investigators planned to do an interim analysis when reaching inclusion of 150 patients. However, this might lead to reduced overall significance level, and as a result of slow inclusion rate (by December 2015), the investigators plan to extend the inclusion time with one year and then complete the study in March 2017.


Eligibility Criteria:
Inclusion Criteria:

* Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).

Exclusion Criteria:

* Nerve root affection and/or radiating pain below the knee.
* Low back pain with suspected "red flags", i.e. infections, tumors and metastatic disease, rheumatic disease, fractures and significant deformities of the spine.
* Low back pain which starts in pregnancy.
* Physician reported sick leave of 14 days or more during the last month before the back pain, for any reason.
Interpretation Bias Modification for Body Dysmorphic Disorder

The purpose of this study is to determine whether a computerized intervention designed to reduce appearance and evaluation related interpretation biases will reduce symptoms associated with body dysmorphic disorder.

The present study aims to examine the feasibility of a remote treatment for body dysmorphic disorder delivered via the Internet. To evaluate the efficacy of the IBM protocol we have developed in reducing negative appearance and evaluative related interpretations, we will conduct a two-arm randomized controlled trial over the internet. Individuals with a diagnosis of body dysmorphic disorder (N = 40) will be randomized to one of two conditions: 1) IBM or 2) progressive muscle relaxation. Each condition will consist of eight 10-25 minute treatment sessions. Participants will complete two sessions per week for four weeks and will be administered assessments at pre-treatment, one week post-treatment and at 3-month follow-up. We hypothesize that: 1) IBM will lead to greater reductions in BDD symptoms than the PMR condition; 2) IBM will lead to greater reductions in depression, anxiety and suicidal ideation than the PMR condition; 3) IBM will lead to greater reductions in threat interpretations and greater increases in benign interpretations than the PMR condition; 4) The effects of condition on BDD symptoms will be mediated by changes in BDD-related interpretation bias; and 5) The effects of training in the IBM condition will be maintained at the 3-month follow-up assessments.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of Body Dysmorphic Disorder according to DSM-5 criteria
* BDD-YBOCS score greater than or equal to 20
* Fluent in English
* No significant physical defect or flaw in appearance (e.g., disfiguration)

Exclusion Criteria:

* History of psychotic disorder, bipolar disorder, borderline personality disorder
* Current substance use disorder
* Unstable medication status (i.e. change in medication within the last month)
* Concurrent psychotherapy for appearance concerns
* Active and clinically significant suicidality