cyrilzakka/clinical-trials huggingface dataset:
Development of a Motivational Intervention to Improve Treatment Adherence in MS

As many as 50% of MS patients prematurely discontinue their disease modifying medications. For this study, we will develop a telephone-based talk therapy intervention and then conduct a randomized controlled trial. Patients will be assigned to either 5 weekly 20 minute telephone sessions of psychotherapy or a brief education control condition. We hypothesize that patients undergoing phone therapy will be more likely to indicate they are interested in resuming taking disease modifying medications than patients given brief education and treatment as usual.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsing remitting MS based on established guidelines
* Previously discontinued recommended therapy
* Provider recommendation for DMT re-initiation
* At least 18 years of age
* Access to a telephone
* English speaking

Exclusion Criteria:

* Diagnosis other than relapsing remitting MS
* Provider does not recommend DMT re-initiation
* Pregnant or breastfeeding (females)
MRI and Cardio-Pulmonary Exercise Testing in Evaluating Exercise Intolerance in Patients With Stage I-III Breast Cancer After Chemotherapy Treatment

This pilot research trial studies magnetic resonance imaging (MRI) and cardio (heart)-pulmonary (lung) exercise testing in evaluating exercise intolerance in patients with stage I-III breast cancer after treatment with chemotherapy drugs called anthracyclines. Anthracyclines are related with heart problems, cardiac abnormalities, bone and muscle dysfunction. Patients with breast cancer who are exposed to anthracycline drugs may also experience progressive fatigue and exercise intolerance which may limit daily activities and is an important barrier for patients returning to work. Using MRI and cardio-pulmonary exercise testing (CPET) may help doctors understand the causes of fatigue and exercise intolerance in patients receiving anthracycline chemotherapy and this may also allow doctors to plan better treatments to protect patients' heart, cardiovascular system, bone and muscle function.

PRIMARY OBJECTIVES:

I. To determine the feasibility of performing upright treadmill cardio-pulmonary exercise stress testing utilizing magnetic resonance imaging.

II. To determine the reproducibility of measures of peak oxygen uptake (V02) and cardiac output as well as arterio-venous oxygen difference (A-V02) difference in survivors of breast cancer treatment and control participants.

OUTLINE:

Patients undergo CPET using a one-way breathing mask in 2 separate days 1-2 weeks apart. Patients also undergo MRI before and within 60 seconds after exercising.

Eligibility Criteria:
Inclusion Criteria:

* Women with stage I-III breast cancer who began their cancer treatment 1-2 years prior to this study and have received anthracycline based chemotherapy
* Women matched to age with our 16 post-cancer treatment participants

Exclusion Criteria:

* Those with contraindications for MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
* Those with contraindications for exercise tolerance test (ETT) testing, including unstable angina or inability to exercise on a treadmill or stationary cycle
* Those who are pregnant, claustrophobic, or unable to provide informed consent
Nissen Sleeve by Single Port With Magnetic Assistance

New approach for Nissen Sleeve Gastrectomy by single port using double magnetic system

A bariatric surgery is performed for weight loss and esophagogastric reflux, called Nissen Sleeve, in which a new approach is used which is the only port that helps to shorten the hospital stay because it decreases postoperative pain as well as increases the esthetic Ad benefit. In addition, a system of magnets is used to assist in different steps of the surgery for the correct retraction of the tissues and to be able to suture or perform the correct dissection.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with controlled comorbidities suffering from obesity and GERD.

Exclusion Criteria:

* Patients with pacemakers, psychiatric problems or uncontrolled metabolic diseases
Pain Relief Investigation of Neuromodulation Therapy in an Adult Fibromyalgia Population

This study is being performed to determine the safety and efficacy of Fralex Neuromodulation Therapy (F-NMT), delivered by the Fralex PRIMA device, in reducing chronic musculoskeletal pain associated with Fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic musculoskeletal pain of at least six months duration secondary to FMS using American College of Rheumatology (ACR) criteria and with the minimum of 11 of 18 defined tender points, measured by dolorimeter at a threshold of up to 4 kg of pressure
* Males and females, 18 years and older
* Able to complete assessment index forms unaided by caregiver/interpreter
* Pain score of 4 or greater on the Numerical Rating Scale (NRS), averaged from the Baseline Period scores recorded on the 7 days immediately prior to randomization
* Demonstration of stabilized pain scores as measured on the NRS during the Baseline Period (Days -7 to -1)
* Able to tolerate prohibition of all medications for pain, depression and sleep disorders except for acetaminophen (up to 4 g/day) and cardiac aspirin (up to 325 mg/day) demonstrated for the Stabilization and Baseline Periods prior to randomization
* Able and willing to provide a written informed consent

Exclusion Criteria:

* Unwilling or unable to sign an informed consent, or to comply with the protocol
* Evidence of inflammatory rheumatic disease, secondary fibromyalgia, or other severe painful disorders that might confound assessment of FMS pain
* Currently under treatment (pharmacological or cognitive therapy) for a Major Depressive Episode (MDE) or has demonstrated suicidal ideation in the past
* History or current treatment of migraine, tension or cluster headache requiring regular medication
* History or current treatment of seizure disorder
* History or current treatment of cancer with the exception of basal cell carcinoma and cervical dysplasia
* Cognitive dysfunction or personality disorder which would preclude self-directed treatment, self assessment and / or diary completion
* Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation
* Hearing aids, metal implants (excludes dental work) above mid torso or in the cranium (e.g. plates, implants or clips). (Metal implants in parts of the body below mid-torso, such as knee or hips replacements, clips, screws or plates to stabilize fractures are acceptable)
* Pacemakers, defibrillators, implanted neurostimulators, implanted drug pumps or other electrical implanted devices
* Insufficient knowledge of English to complete the self-assessment forms
* History of or current drug or alcohol abuse
* History of abuse of a previous physician relationship or the medical system
* Receiving disability insurance, applying for disability insurance, or engaged in litigation related to FMS
* Use of an investigational drug or device in a controlled study within 30 days
* Pregnancy (U.S. sites only)
* Breastfeeding or intending to breastfeed (U.S. sites only)
Transesophageal Echocardiography in Embolic Stroke of Undetermined Source

The ESUS concept was introduced recently to describe a non-lacunar stroke of undetermined etiology. The following etiological workup is required in this setting: head CT or MRI, 12-lead ECG, transthoracic echocardiography, continuous cardiac monitoring for at least 24 hours after stroke, vascular imaging (ultrasound, magnetic resonance angiography, CT angiography, catheter angiography). Transesophageal echocardiography (TEE) is considered not to be required.

However, aortic arch atheroma as diagnosed by TEE in the setting of recent ischemic stroke is a major aortic source of embolism, as supported by numerous well conducted studies. The European Association of Echocardiography considers that TEE is the gold standard for the diagnosis and the characterization of aortic atheroma. It is also the method of choice for the diagnosis of infectious endocarditis.

The aim of this work was to evaluate the rate of patients with a therapeutic modification induced by TEE (mainly anticoagulation and surgery), in consecutive patients admitted with ESUS at our institution stroke unit.


Eligibility Criteria:
Inclusion Criteria:

* Presenting with a new onset of ischemic stroke
* Meeting the ESUS criteria (Embolic Stroke of Undetermined Source)
* Comprehensive transthoracic echo prior to the TEE

Exclusion Criteria:

* ESUS criteria not met
* Contraindications to TEE
* TEE failure
* Pregnant or breastfeeding woman
* Person under legal protection
* No medical insurance coverage
A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis

This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
* Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
* Psychotic symptoms must have developed after PD diagnosis was established
* Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to Study Day 1 (Baseline) and during the trial
* Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
* The subject is willing and able to provide consent
* Caregiver is willing and able to accompany the subject to all visits

Exclusion Criteria:

* Subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
* Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
* Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
* Subject has had a myocardial infarction in last six months
* Subject has any surgery planned during the screening, treatment or follow-up periods

Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).
Follow up by General Practitioner After Self-poisoning

The study hypothesis is that follow up from general practitioner after hospitalization for self poisoning will decrease suicidal behaviour.

Patients hospitalized after an episode of self poisoning will be randomly assigned into intervention an control groups. The intervention is close follow up by general practitioner six months. Both groups will receive treatment as usual.

Eligibility Criteria:
Inclusion Criteria:

* Self Poisoning (according to the WHO definition)
* Ability to fill out questionnaire

Exclusion Criteria:

* Hospitalization into psychiatric ward
* Unknown address or ID
* Not registered with General Practitioner
* If institutionalized or in jail.
Monitoring Anticoagulation in Patients on ECMO for Severe Lung Failure

A monocentric observational study evaluates the accuracy of anticoagulation monitoring in critically ill patients on ECLS (extracorporeal life support) using new markers of the effect of direct thrombin inhibitors and also the accuracy of anticoagulation monitoring in patients on unfractionated heparin using anti-Xa. A more accurate setting of anticoagulation may lead to a reduction in the number of serious bleeding and thrombotic complications in these patients.

Anticoagulation using a direct thrombin inhibitor, argatroban, is one of the modern options for anticoagulation in patients on VV (veno-venous) ECMO (extracorporeal membrane oxygenation) support, and in 2021 the ECMO center of the University Hospital Ostrava changed the standard anticoagulation using UHF (unfractionated heparin) to anticoagulation using Argatroban as a new standard of routine care. Argatroban shows more stable levels and has a short half-life, and a number of foreign ECMO centers have been using Argatroban for a long time also as basic anticoagulation in all ECMO patients.

To monitor the effect of direct thrombin inhibitors, it is possible to use monitoring of anti-FIIa activity, which directly assesses the effect of the anticoagulant on thrombin activity. Anticoagulation with Argatroban may reduce the risk of serious bleeding complications. Target values of aPTT (Activated Partial Thromboplastin Time) and anti-FIIa can be determined according to ELSO (Extracorporeal Life Support Organization) guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Patients with COVID-19
* ARDS according to the Berlin definition
* Veno-venous (VV) ECMO
* Full coagulation with Argatroban or heparin to an anti-FIIa value of 0.4-1.5 or aPTT 50-60

Exclusion Criteria:

- age under 18 years
Immune Cells in Diabetic Chronic Foot Ulcers

The goal of this observational study is to learn about the role of immune cells in patients with diabetes and chronic foot ulcers. Researchers will compare blood and tissue samples of patients with diabetes and a foot ulcer that is healing or healed compared to those diabetic patients where the foot ulcers is not healing (chronic ulcer).

Diabetic foot ulcer (DFU) requires frequent hospital visits, anti-biotic therapies, and surgical procedures. Not only this approach has debilitating consequences for patients and enormous costs for the health care system, but it is often not sufficient to prevent lower limb amputation. The immunological response in wound healing is mainly orchestrated by recruited monocytes and skin macrophages. The current hypothesis is that hyperglycaemia sustains an activated macrophages' phenotype that inhibits wound healing. However, well controlled diabetes is not associated with better healing, and not all the diabetic patients develop chronic foot ulcers. In this project, the investigators aim to characterize the immunological response of patients with DFU to discover new therapeutic targets for the treatment of chronic wounds. The investigator suggest that an altered metabolic local environment can re-program monocytes/macrophages towards dysfunctional phenotypes unable to accomplish the healing process. Here, by using a longitudinal study cohort combined with clinical information, transcriptomic and proteomic analysis at single cell level, researchers will characterize the landscape of monocytes/macrophage populations involved in healing, and non-healing, foot ulcers. Functional validation will be performed in human skin organoids. My group's unique access to patient material combined with cutting-edge methodologies provides an exceptional platform to identify genes and pathways involved in chronic DFU.

Eligibility Criteria:
Inclusion Criteria:

* diabetes with diabetic foot ulcer

Exclusion Criteria:

* impaired cognitive function
* on-going immune suppressive treatment
* diagnosed active cancer
* cancer treatment
* known chronic inflammatory disease
Duloxetine for LBP

This research study will help determine whether a medication called duloxetine can improve back pain. It is well documented that many participants who come to the ER with acute low back pain still have low back pain 3 months later. The investigator team will attempt to determine whether duloxetine can help prevent this.

Participants will be eligible to take duloxetine/placebo if insufficient relief of pain after using naproxen for 48 hours has been reported.

Eligibility Criteria:
Inclusion Criteria:

* Present to Emergency Department (ED) primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.
* Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the ED visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal LBP.
* Patient is to be discharged home. Patients admitted to the hospital are more likely to be treated with parenteral medication and therefore are not appropriate for this study.
* Age 18-64 Enrollment will be limited to adults younger than 65 years because of the increased risk of adverse medication effects in older patients.
* Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
* Pain duration \<2 weeks (336 hours).
* Prior to the acute attack of LBP, back pain cannot occur more frequently than once per week.
* Functionally impairing back pain: A baseline score of \> 5 on the Roland-Morris Disability Questionnaire

Exclusion Criteria:

* Not available for follow-up
* Pregnant or breast-feeding
* Chronic pain syndrome defined as moderate or severe pain anywhere in their body on \>= 50% of days for at least three months
* Allergic to or intolerant of investigational medications
* Contra-indications to non-steroidal anti-inflammatory drugs:

  1. history of hypersensitivity to NSAIDs or aspirin
  2. active or history of peptic ulcer disease, chronic dyspepsia, or active or history of gastrointestinal bleed
  3. Severe heart failure (NYHA 2 or worse)
  4. uncontrolled blood pressure (\>160/100)
  5. Glomerular Filtration Rate (GFR) \<60ml/min
  6. Current use of anti-coagulants
  7. cirrhosis or acute hepatitis
* Contra-indication to duloxetine:

  1. alcohol use disorder
  2. chronic liver disease
  3. chronic kidney disease
  4. glaucoma
  5. Active use of medication for depression
  6. Score \> 10 on the Patient Health Questionnaire (PHQ-9) screening instrument or thoughts of suicide, symptoms of feeling down, depressed, or hopeless

PHQ9 score \>4. Now we would like to exclude patients with a PHQ9 score \>10 or symptoms of feeling down, depressed, or hopeless
Validation of the Measurement Accuracy of the Tcore Thermometer

The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the body core temperature thermometer Tcore®. Therefore the bias of the measurements to the reference measurements of the bladder catheter thermometer is determined.

The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the body core temperature thermometer Tcore®. Therefore the bias of the measurements to the reference measurements of the bladder catheter thermometer is determined.

Patients included are in the ICU of the UKSH and awake. They already have the reference thermometer in the catheter. The patient investigation time is limited to maximum 2 hours, SAEs will be recorded for 24 hours. The temperature of the two temperature sensors will be compared on three timepoints.

Eligibility Criteria:
Inclusion Criteria:

* Body temperature \> 34 °C
* Signed consent
* Bladder catheter with temperature sensor

Exclusion Criteria:

* Inflammation of the frontal sinus or the measuring point of the reference measurement (bladder)
* Skin irritation to the adhesive or other materials used
* medication that locally affects the body temperature or the temperature of the reference body site (barbiturates, thyroid preparations, antipsychotics, new vaccines, aspirin, acetaminophen, ibuprofen, or similar)
* Taking antipyretics in the last 120 minutes before measurement
Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe LUTS Due to BPH

Single dose versus double dose tamsulosin in Management of Moderate and severe lower urinary tract symptoms due to benign prostatic hyperplasia


Eligibility Criteria:
Inclusion Criteria:

* age more than 50 years
* moderate to severe lower urinary tract symptoms

Exclusion Criteria:

* prostatic cancer
* urethral stricture
* prostate surgery
* Neurogenic bladder
An Investigational Scan (hpMRI) for Monitoring Treatment Response in Patients With Thyroid Cancer and Other Malignancies of the Head and Neck Undergoing Radiation Therapy and/or Systemic Therapy

This trial investigates whether hyperpolarized magnetic resonance imaging (hpMRI) can predict treatment response in patients with thyroid cancer and other malignancies of the head and neck undergoing radiation therapy and/or receiving systemic therapy before surgery. An hpMRI is like a standard MRI but involves the use of an imaging contrast agent called hyperpolarized 13-C-pyruvate. Diagnostic procedures, such as hpMRI, may predict a patient's response to treatment and may help plan the best treatment.

PRIMARY OBJECTIVE:

I. To obtain pilot metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods in patients with thyroid tumors or other malignancies of the head and neck receiving radiation therapy (XRT) and/or systemic therapy (e.g., target therapy, checkpoint inhibitors).

SECONDARY OBJECTIVE:

I. To assess early metabolic changes in response to nonsurgical therapy, including standard-of-care fractionated XRT and/or systemic therapy.

OUTLINE: Participants are assigned to 1 of 2 arms.

ARM I: Healthy volunteers undergo MRI over 30 minutes.

ARM II: Patients with thyroid cancer and other malignancies of the head and neck undergo hpMRI over 30 minutes at baseline, and at 1 week after the initiation of treatment. During the scan, patients also receive hyperpolarized 13-C-pyruvate intravenously (IV) over 30 seconds and may receive a standard MRI contrast agent at the discretion of the treating physician.

After completion of study intervention, thyroid cancer and other malignancies of the head and neck patients are followed up at 1 day.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to provide informed consent
* Be informed of the investigational nature of this study
* Be diagnosed with thyroid cancer and other malignancies of the head and neck with intent for treatment

Exclusion Criteria:

* Have a history of severe claustrophobia
* Have electrically, magnetically or mechanically activated implants that would preclude magnetic resonance imaging (MRI)
* Have a history of cardiac arrhythmia
* Have an allergy to Gadavist intravenous contrast
* Estimated glomerular filtration rate (eGFR) \< 30
* If female, be pregnant or breast feeding at time of consent