cyrilzakka/clinical-trials huggingface dataset:
LDN and tDCS in Fibromyalgia

Fibromyalgia is a complex generalized and diffuse musculoskeletal chronic pain; and pharmacological approaches are widely used to relieve pain and increase life quality. In this context, low-dose naltrexone (LDN) was able to increase nociceptive threshold in patients with fibromyalgia. Moreover, non-pharmacological techniques, like Transcranial Direct Current Stimulation (tDCS), have been shown effective for pain management. This study aims to evaluate the analgesic and neuromodulatory effect of combined LDN followed by tDCS in fibromyalgia patients. This is a randomized, double-blinded, parallel, placebo/sham-controlled trial, in which 92 (10% loss) women with fibromyalgia will be included included and signed the informed consent. Patients will be allocated into 4 groups: tDCS+LDN (n=21), Sham-tDCS+LDN (n=22), tDCS+Placebo (n=22), and Sham-tDCS+Placebo (n=21). LDN or placebo (p.o.) intervention lasts 26 days, in the last five, tDCS will be applied (sham or active, 20min, 2mA). Questionnaires assessed are: Sociodemographic, Visual Analog Pain Scale (VAS), Pain Catastrophizing Scale (PCS), State-Trait Anxiety Inventory (STAI), Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI-II), Chronic Pain Profile Scale (CPP). Also, pain measures were taken: Pain Pressure Threshold (PPT) and Conditioned Pain Modulation (CPM). Blood samples will be collected to analyze Brain Derived Neurotrophic Factor (BDNF) serum levels.


Eligibility Criteria:
Inclusion Criteria:

* signed the consent form
* women from 18 to 65 years
* confirmed diagnosis of fibromyalgia according 2016 American College of Rheumatology criteria
* read and write
* pain higher than 6 in the Visual Analogue Scale (VAS), in the last 3 months
* chronic stable treatment in the last 3 months.

Exclusion Criteria:

* in use of opioid drugs;
* pregnancy or not using anticontraceptive
* history of alcohol or drug abuse in the last 6 months
* history of neurological pathologies
* history of arrhythmia
* history of use of drugs that might change vascular response
* history of head trauma
* history of neurosurgery
* decompensated systemic diseases or chronic inflammatory diseases (lupus, rheumatoid arthritis, Sjogren syndrome, Reiter syndrome)
* history of non-compensated hypothyroidism
* personal history of cancer.
mHealth + e-Navigator Stepped Care on ART Adherence in Latino MSM

The goal of this study is to evaluate the efficacy of stepped care strategies to improve ART adherence among adult Latino MSM with HIV using a sequential, multiple assignment, randomized trial (SMART). The trial will compare a stepped care strategy of delivering TXTXT ("Treatment Text") first and stepping up to remote patient navigation for non-responders vs. a stepped care strategy of delivering TXTXT + e-Navigation first and stepping up to EMA-supported e-Navigation for non-responders. Both TXTXT and the foundations of the e-Navigation interventions are CDC evidence-based interventions (EBI). We propose to use a SMART design which explicitly allows building, testing, and optimizing stepped care strategies without compromising rigor or randomization. We propose three specific aims:

Aim 1. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two static (non-stepped) treatment regimens (TXTXT alone vs. TXTXT + e-Navigation) on ART adherence and viral suppression among Latino MSM with HIV. Hypothesis 1a. TXTXT + e-Navigation will be more efficacious than TXTXT alone. Aim 2. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two stepped care strategies (TXTXT with added e-Navigation for non-responders vs. TXTXT + e-Navigation with added EMA support for non-responders) on ART adherence and viral suppression among Latino MSM with HIV. Hypothesis 2a: TXTXT + e-Navigation with added EMA support for non-responders at the 3-month follow-up will be more efficacious than TXTXT with added e-Navigation for non-responders at the 3-month follow-up. Aim 3. Identify baseline and time-varying moderators on the association between stepped care strategy and ART adherence and viral suppression among Latino MSM with HIV. Hypotheses 3a-c: TXTXT with added e-Navigation for non-responders will be less efficacious than TXTXT + e-Navigation with added EMA support for non-responders for individuals who are: (a) older at baseline, or report (b) substance use, or (c) symptoms of depression between baseline and the 3-month follow-up.


Eligibility Criteria:
1. Latino or Hispanic
2. Self-report male gender assigned at birth and identify as gay, bisexual, or previous sex with a man
3. Age 18 or older
4. Diagnosed with HIV and prescribed ART least 1 month prior to study screening and enrollment
5. Suboptimal adherence defined as (1) laboratory evidence of at least one detectable viral load in the past 12 months (≥20 copies/mL), (2) electronic medical record of at least one \<90% 30-day adherence period in the past 12 months, or (3) self-reported \<90% past 30-day adherence.
6. Cell phone ownership and SMS use: Participants must own a personal cell phone for the intervention.
Atrial Fibrillation in Active Cancer Patients

Atrial fibrillation is a common complication of both cancer and anticancer drugs but the consequences of such events remain poorly known and are not adressed in both phase III oncological trials and cardiological guidelines. The objective of this study is to create a prospective multicenter international registry of adult patients with an active cancer and experiencing atrial fibrillation to study major cardiovascular events occurrence during a 1 year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* outpatients or hospitalized patients
* with a confirmed cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor, known intracerebral metastases, or acute leukemia) and an active cancer (defined as cancer that had been diagnosed within the past 6 months or recurrent locally advanced or metastatic cancer, for which anticancer treatment was being given at the time of enrollment or during 6 months before enrollment)
* at least 1 episode of atrial fibrillation (new onset AF occuring after cancer diagnosis or history of paroxysmal of persistant AF prior to cancer diagnosis and an AF recurrence after cancer diagnosis)
* in sinus rhythm at the time of cancer diagnosis

Exclusion Criteria:

* patient with palliative cares or other conditions resulting in short term death (death expected in the month following atrial fibrillation occurrence)
* history of long-standing persistant or permanent AF prior to cancer diagnosis
The Effect of Orally Administered Metoprolol on the Frequency and Severity of Rocuronium Injection Pain

In this study, we aimed to investigate the effect of metoprolol on the frequency and severity of pain caused by rocuronium injection in patients who started to use and were currently using oral metoprolol for any reason such as ischemic heart disease, hypertension, and arrhythmias. All patients were informed about the objectives of the study and gave informed written consent. The study was conducted in accordance with the relevant ethical principles of the Declaration of Helsinki. This study was planned as a prospective, placebo-controlled, cohort study were evaluated in four groups. Group M: patients currently using metoprolol and who did not receive lidocaine before the application of rocuronium. Group ML: patients currently using metoprolol and who received lidocaine before rocuronium application. Group L: patients currently not using metoprolol and received lidocaine before rocuronium application. Group C: patients currently not using metoprolol and who did not receive lidocaine before rocuronium application. 200 patients with 50 being in each of four groups were included in the study.

Following the induction of general anesthesia with thiopental sodium, a researcher blind to the groups observed the pain during rocuronium injection based on the following scale:

1: no reaction, 2: movement only in the ankle, 3: movement or withdrawal only in the arm (shoulder and ankle), 4: diffuse reaction (movement or withdrawal in more than one extremity, coughing and holding breath).Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), and SpO2 values were recorded before rocuronium administration, 1 and 3 minutes after rocuronium induction, and after intubation. Anesthesia maintenance was performed according to the discretion of the anesthetist. We checked the injection site regarding edema, rash, and thrombophlebitis after the first 24 hours of the operation.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years, ASA I-III, patients who received general anesthesia, patients who were using oral metoprolol for any reason such as ıschemic heart disease, arrhythmias.

Exclusion Criteria:

* Patients under 18 and above 75 years of age, with ASA IV class, those with known allergy to rocuronium and lidocaine, patients with chronic pain, pregnant women, those who had received analgesics or sedatives, and patients who were receiving calcium channel blocker that could affect pain were excluded from the study.
Molecular Profile of Thyroid Nodules

Profiling and comparative analysis of genomic alterations and miRNA expression in benign and malignant thyroid tumors using histological and cytological specimens will be performed. Obtained information is necessary to create a molecular test to refine the cancer risk of cytologically indeterminate thyroid nodules.

This is an non-randomised retrospective study consisting of 2 parts. Part A. Histological specimens (formalin fixed paraffin embedded) of patients who were operated on for benign and malignant thyroid disorders will undergo molecular testing to create a molecular profile of thyroid nodules characteristic of Belarusian population.

Part B. Fixed cytological smears of indeterminate thyroid nodules (categories III, IV and V according to Bethesda scoring system) of operated patients will undergo molecular testing to evaluate the possibility and reliability of molecular testing of fixed cytological smears using available assays.

Eligibility Criteria:
Inclusion Criteria:

Patients operated on for malignant and benign thyroid tumors. Age is greater than or equal to 18 years old.

Exclusion Criteria:

no
Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography

The purpose of this study is to demonstrate diagnostic agreement and determine the accuracy of the continuous positive airway pressure (CPAP) device compared to simultaneous, attended clinical polysomnography (PSG) in identifying breathing events in participants previously diagnosed with complex sleep apnea (CompSAS), complex sleep apnea with Cheyne-Stokes respiration (CSR), or obstructive sleep apnea (OSA).

Study Objectives: To compare a positive airway pressure (PAP) device's detection of respiratory events and airway status during device detected apneas with events scored on simultaneous polysomnography (PSG).

Design: Prospective PSGs of patients with sleep apnea using a new-generation PAP device.

Settings: Four clinical and academic sleep centers.

Patients: Forty-five patients with obstructive sleep apnea (OSA) and complex sleep apnea (Comp SA) performed a PSG on PAP levels adjusted to induce respiratory events.

Interventions: None.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, ages 21-80.
* Able and willing to provide written informed consent.
* Diagnosis of complex sleep apnea (CompSAS) or Obstructive Sleep Apnea (OSA) within one year of study participation.
* For participants with CompSAS: (a) Diagnostic PSG with an Apnea-Hyopnea Index (AHI) greater than or equal to 10 events/hour and central apnea index (CAI) greater than or equal to 5 events/hour of sleep or (b) PAP titration with a CAI greater than or equal to 5 events/hour of sleep.
* For participants with OSA, a diagnostic PSG with an AHI greater than or equal to 15 events/hour of sleep.
* Must have had a CPAP titration such that the necessary PAP level to treat the sleep disordered breathing is known.
* Agreement to undergo a full-night, in-laboratory PSG on CPAP device.

Exclusion Criteria:

* Participation in an interventional research study within 30 days of study participation.
* Pre-menopausal females known to be pregnant or who are sexually active and not using a reliable method of birth control.
* Surgery of the upper airway, nose, sinus, or middle ear within the last 90 days.
* Surgery at any time for the treatment of OSA such as uvulopalatopharyngoplasty (UPPP).
* Major medical or psychiatric condition that would interfere with the demands of the study, adherence to positive airway pressure, or the ability to complete the study.
* Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe Chronic Obstructive Pulmonary Disease (COPD) or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (\> 45 mmHg) while awake.
* Currently prescribed oxygen therapy.
* Ventilatory induced barotrauma within 6 months of study participation.
* Untreated insomnia.
* Other major medical condition that, in the judgment of the investigator, precludes participation in this study.
Treatment of Chronic Migraine With Erenumab Alone or as an Add on Therapy

Treatment of chronic migraineurs who have failed more than 3 preventive drugs with Erenumab alone, to reduce frequency of monthly migraine days or as an add on therapy

The investigators treated chronic migraineurs that have failed more than 3 preventive drugs with Erenumab alone or as an add on therapy to: Reduce the frequency of monthly migraine days, to evaluate If the add on of Erenumab to another preventive therapy is superior to Erenumab alone, and assess all adverse events related to the use of Erenumab.

Migraineurs with 15-30 migraie days per month at baseline were clustered in 3 categories. Failure of Erenumab was defined as no improvement in the frequency of monthly migraine days. Group I: no preventive therapy, prior to the start of Erenumab. (No botox cohort). Group II: on Botulinum Toxin A (Botox), prior to the add on therapy with Erenumab. (Botox cohort).Group III: on an oral preventive drug, prior to the add on therapy with Erenumab. (No Botox cohort)

Eligibility Criteria:
Inclusion Criteria:

* chronic migraineurs with failure to more than 3 preventive treatments
* Naive to anti CGRP monclonal antibodies

Exclusion Criteria:

* episodic migraineurs,
* Other headache types
Correlation of Thoracolumbar Fascia Mechanical Properties and Compensate Mechanisms of Asymmetric Skeletal Muscle

The objective of three-year research is to investigate the relationship between thoracolumbar fascia tissue characteristics, lumbopelvic asymmetry, core muscle contractility, proprioception and standing balance in different ages of asymptomatic participants and patients with CMLBP.

Background: Chronic myofascial low back pain (CMLBP) is a common musculoskeletal disease. Deep fascia is the structures which insufficient in the theory of spinal stability, the major biomechanical role of the thoracolumbar fascia are segmental control and stability of the spine and sacroiliac joint, its biomechanical role is influenced by its mechanical properties of the fascia. Fascia provide the function of sensation and coordination, it is helpful for discussion the compensatory mechanisms for patients with chronic low back pain, and contribution to the development of appropriate therapeutic strategies or combined treatments in innovative applications. However due to the lack of understanding of myofascia, there are difficulties in diagnosis and treatments. It is necessary to establish methods of assessing fascia and complete series of study for understanding fascia and its attaching muscles.

Objective: The objective of three-year research is to investigate the relationship between thoracolumbar fascia tissue characteristics, lumbopelvic asymmetry, core muscle contractility, proprioception and standing balance in different ages of asymptomatic participants and patients with CMLBP.

Method: 270 subjects are recruited in this study, with ages ranging from 20 to 74 years old. 120 of the subjects are patients with CMLBP and 150 are asymptomatic participants. Instrument in use including real time ultrasound imaging, Zebris 3D motionanalysis system and force plate system. The first year is to establish the reliability of measurement of lumbopelvic asymmetry, mechanical and physical properties of thoracolumbar fascia, and the norm of different age. The second year is to compare the differences among asymptomatic subjects and patients with and without lumbopelvic asymmetry, and investigate whether lumbopelvic symmetry, core muscle contractility, proprioception and standing balance change after manipulating thoracolumbar fascia tissue by physical therapy. The third year is to investigate the treatment effect on chronic myofascial back pain patient after 8 weeks exercise training with the aid of physical agent.

Eligibility Criteria:
Inclusion criteria:

* Asymptomatic subjects
* Age between 20-74 years old
* In the past three months did not feel uncomfortable more than one day on waist region, and did not relapsed more than once within three months

Subjects with chronic low back pain

* Age between 20-74 years old
* In the past three months felt uncomfortable more than one day on waist region, and relapsed more than once within three months
* Visual pain scores (VAS ≧ 3)

Exclusion criteria:

1. Can not communicate clearly with people
2. Any open wounds
3. Any history of cancer or malignancy
4. The bleeding disorders
5. Pregnancy
Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal (PAPIRUS III)

The PAPIRUS III study will continue to follow patients initially enrolled in PAPIRUS II. Pressure readings from the investigational device will continue to be collected and will be correlated to physiological changes during activities of daily living and protocol defined tests.

This is a small clinical trial to determine the feasibility of a device \& to test prototype device, where the primary outcome measure relates to feasibility and not to health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patient has been enrolled in the PAPIRUS II Study and has a RemonCHF pressure sensor implanted
* Patient is willing and able to provide informed consent, participate in the Safety Follow-up Program and/or in the required tests associated with the clinical investigation (Core Study Program) at an approved clinical investigational center and at the intervals defined by the Clinical Investigational Plan.

Exclusion Criteria:

* Patient enrolled in PAPIRUS II but not implanted with a RemonCHF Pressure Sensor
* Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study (with the exception of the PAPIRUS II Study). Each instance would be brought to the sponsor to determine eligibility.
* Age \< 18 years
* Women of childbearing potential who are, or might be, pregnant at the time of the study
Comparison of Effect of Anterior Subcutaneous and Submuscular Transposition on Cubital Tunnel Syndrome

The purpose of this study is to determine which surgical method is better for cubital tunnel syndrome in outcomes.

Compression of the ulnar nerve at the cubital tunnel is the most common cause of numbness on the ulnar side of the hand. We aimed to compare patient outcomes included pain, sensation, muscle strength and muscle atrophy in two methods of surgery contain Anterior Sub Cutaneous Transposition (ASCT) and Anterior Sub Muscular Transposition (ASMT) of the ulnar nerve in Cubital tunnel syndrome.

Eligibility Criteria:
Inclusion Criteria:

* patients with confirmed cubital tunnel syndrome

Exclusion Criteria:

* Significant cervical spine and shoulder disease
* deformity or distortion of the cubital tunnel due to previous trauma to elbow
* recurrent cubital tunnel syndrome after previous surgery.
An Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia

This multicenter, prospective, non-interventional study will evaluate the prevalence and characteristics of patients with persistent symptoms of schizophrenia and the course of their illness over 24 months.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Adult patients, \>/= 18 years of age
* Diagnosis of schizophrenia according to Diagnostic and Statistical Manual for Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) or International Classification of Diseases, 10th revision (ICD-10)

Caregivers:

* Age \>/= 18 years
* Family member or friend of the patient, who spends at least 4 hours a week with the patient

Exclusion Criteria:

* Acute psychotic exacerbation in the 3 months prior to the baseline observation (e.g. hospitalization or increased psychiatric care in order to prevent hospitalization)
* Enrolled in an interventional study at the baseline observation
Evaluation of a Marine OXYgen Carrier: HEMO2Life® for hypOthermic Kidney Graft Preservation, Before Transplantation (OXYOP)

Kidney transplantation is the treatment of choice for end stage renal diseases, increasing life expectancy and quality of life. Improvement in organ preservation is a critical issue in this context.

This is a safety study evaluating the use of an oxygen carrier HEMO2Life® as an additive in organ preservation solution in kidney transplantation.

Security of the use of HEMO2Life® will be analyzed by collecting all events within the first 3 months in terms of :

1. HEMO2Life® adverse effects
2. graft safety
3. recipient safety (any adverse event) Accountability search will be achieved for each of these events.

Eligibility Criteria:
Inclusion Criteria:

For Kidney :

The first ten local kidneys in each participating centers that do not meet the exclusion criteria.

* Graft retrieved in an adult donor
* Graft from a deceased donor after brain death (DBD)
* Graft locally transplanted in one of the 6 kidney transplant centers participating in the study
* Graft stored in preservation solution containing HEMO2Life®

For Patient :

Patient who signed an inform consent form In case of patient unable to signed an inform consent form for patient under judicial protection (supervision, guardianship) the inform consent form will be obtain from the patient himself and from the supervisor/guardianshiper/parents, they will signed together the patient inform consent form.

The probability of the inclusion of a patient unable to signed an inform consent form is low but we can't know the receiver before conditioning the graft.

Patient \> 18 years old

Exclusion Criteria:

* Graft from a living donor
* Graft from a donor after cardiovascular death (DCD)
* Graft dedicated to a multi-organ transplantation