cyrilzakka/clinical-trials huggingface dataset:
Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis

The goal of this interventional non-pharmacological study is to evaluate the involvement of the autonomic nervous system in patients with relapsing-remitting and primary progressive multiple sclerosis.

The main questions it aims to answer are:

* Is it possible to define the characteristics of dysautonomia to improve treatment on patients with multiple sclerosis through the management of conditions such as orthostatic hypotension or thermoregulation disorders that inevitably condition the patient's life and the response to rehabilitation ?
* Does the severity of the functional alterations correlate with impairment of small somatic and autonomic cutaneous nerve fibers in patients with multiple sclerosis ?
* How much the involvement of the autonomic nervous system affects the clinical history and progression of the disease ?
* Do different clinical variants of multiple sclerosis manifest with different patterns of involvement of the sensory-autonomic nervous system ?

Participants will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment. Patients will perform a sensory and autonomic functional study and a morphological analysis of cutaneous nerves through skin biopsy.

Researchers will compare results between the two groups (relapsing-remitting and primary progressive) and between patients and data from control subjects.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of relapsing-remitting and primary progressive multiple sclerosis.

Exclusion Criteria:

* other forms of multiple sclerosis,
* known other neurological disorders
* assumption of potentially neurotoxic substances or drugs.
Antimicrobial Pharmacokinetics in Critically Ill Adults During Sustained Low Efficiency Dialysis (SLED)

Severe acute kidney injury (AKI) is a common complication of critical illness affecting almost half of all patients with septic shock. Extracorporeal renal replacement therapy is a cornerstone in the management of AKI in these patients. Options for renal replacement therapy include continuous renal replacement (CRRT) therapy, intermittent dialysis (IHD) or a hybrid form of the two called sustained low efficiency dialysis (SLED). Globally there is a push to switch from traditional CRRT to SLED. Although there are resource and financial comparative benefits to SLED there is almost no literature describing how to dose antimicrobials (or other drugs for that matter). It appears that drug clearance on SLED may be more efficient than CRRT but not as efficient as IHD making extrapolation from these bodies of literature inappropriate for SLED. The investigators are proposing to conduct the population pharmacokinetic studies for the three most commonly used antimicrobials in critically ill patients receiving SLED therapy (piperacillin-tazobactam, meropenem and vancomycin). Population pharmacokinetic modeling of these drugs will provide estimates and sources of variability around pharmacokinetic parameters that will subsequently be used for Monte Carlo simulation to determine the most appropriate dosing regimens to achieve therapeutic targets while minimizing the risk of toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Critically ill adults \[age ≥ 18\] admitted to one of two of the medical/surgical intensive care units (ICUs) of The Ottawa Hospital, who require SLED and are or will receive meropenem, piperacillin-tazobactam or vancomycin therapy at any dose.

Exclusion Criteria:

* Patients for whom participation via the informed consent process is denied.
* Critically ill patients with a hypermetabolic state due to \>25% coverage of body surface area burn, cystic fibrosis, spinal cord injury, bariatric patients (defined as \>150kg total body weight)
* Patient is pregnant as per a positive serum or urine βHCG qualitative assay
* Patient does not have a closed-system arterial or central venous catheter (to minimize blood wastage)
* Patients receiving concomitant drugs known to interact with the metabolism or clearance of the antimicrobial of interest according to Micromedex 2.0 (Truven Health Analytics Inc 2013)
Metformin Use and Vitamin B12 Deficiency

The primary objective is to determine the incidence of Vitamin B12 deficiency in patients on metformin therapy for diabetes.


Eligibility Criteria:
Inclusion Criteria:Age 20-80; diagnosed with type 2 diabetes for at least 30 days

Exclusion Criteria:known vitamin B12 or folate deficiency; pernicious anemia; on vitamin B12 therapy; hematological malignancy; methotrexate use; alcohol intake greater than two drinks per day; vegetarian diet; previous gastric surgery; inflammatory bowel disease
Allo BMT in Advanced Leukemia or High Grade Lymphoma

To evaluate the role of ablative allogeneic hematopoietic cell transplantation in the treatment of advanced leukemia or lymphoma.

To determine the disease free survival and overall survival of patients with ALL and ANLL after induction failure, in relapse, or subsequent remission from CML in several phases or recurrent lymphoblastic lymphoma who receive fractionated TBI, etoposide and cyclophosphamide followed by allogenic bone marrow grafting from histocompatible sibling donors. Fractionated Total Body Irradiation (FTBI), Etoposide (VP-16) and Cyclophosphamide (CY) Followed by Allogeneic Bone Marrow Transplantation for Patients with Advanced Leukemia or High Grade Lymphoma

Eligibility Criteria:
Inclusion Criteria:HLA identical donor

* adequate organ function
* other life threatening disease
Psychosocial Adjustment After Radiation Therapy in Patients With Cancer

RATIONALE: Gathering information about psychological and social adjustment after radiation therapy in patients with cancer may help doctors plan the best treatment.

PURPOSE: This clinical trial is studying psychosocial adjustment after radiation therapy in patients with breast cancer, colorectal cancer, lung cancer, or prostate cancer.

OBJECTIVES:

* To describe psychosocial adjustment after radiotherapy in patients with stage I, II, or III breast, colorectal, lung, or prostate cancer.
* To determine if cognitive appraisal of health predicts psychosocial adjustment of these patients after radiotherapy.
* To examine whether social support moderates the relationship between cognitive appraisal of health and psychosocial adjustment of these patients after radiotherapy.
* To examine whether self-efficacy for coping with cancer moderates the relationship between cognitive appraisal of health and psychosocial adjustment of these patients after radiotherapy.
* To measure the effect of symptom distress, uncertainty, medical factors, and personal factors on cognitive appraisal of health of these patients before ending radiotherapy.

OUTLINE: Two weeks before completing planned radiotherapy, patients undergo assessment of stress appraisal and other factors predictive of post-radiotherapy psychosocial adjustment. Patients complete psychosocial assessments, including measures of patient perceptions of their illness (i.e., cognitive appraisal) and of the factors influencing their perceptions (i.e., uncertainty by the Mishel Uncertainty in Illness Scale-Community Form; symptom distress by the Memorial Symptom Assessment Scale Short Form; and comorbidity by the Charlson Comorbidity Index). Measures of patient social support and self-efficacy for coping are also assessed. At 1 month after completion of radiotherapy, patients undergo repeat assessment of stress appraisal and psychosocial adjustment.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast, colorectal, lung, or prostate cancer

  * Stage I, II, or III disease
  * Nonmetastatic disease
* Undergoing first course of curative radiotherapy, as indicated in the medical record

  * Receiving treatment as an outpatient
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Able to receive treatment as an outpatient
* Lives in northeastern Ohio
* Cognitively intact, as evidenced by orientation to person, place, and time
* Has a telephone
* No hearing impairment (must be able to hear instructions)
* No malignancy expected to require surgery or chemotherapy ≤ 2 months after treatment

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior radiotherapy for another type of cancer
* No concurrent or planned chemotherapy or surgery for at least 2 months after radiotherapy
* No concurrent treatment for recurrent cancer
Efficacy of Symbicort pMDI Administered Once Daily in Adolescents and Adults During 12 Weeks - STEM

The purpose of this study is to compare a dose of Symbicort taken once daily with other dosage regimens of Symbicort , budesonide and placebo for the treatment of asthma in adolescents and adults


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma and baseline lung function tests as determined by the protocol
* Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria:

* Severe asthma
* Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers
Brain Aging Project--Kansas University

The purpose of this study is to determine the effects of exercise and cardiorespiratory fitness on age-related brain changes.

The mission of the KU Brain Aging Project is to promote healthy brain aging. How the brain changes with age is not well-characterized and even less is known about the factors influencing the rate of brain aging. Thus, we are using MRI scans to examine the structure of the brain in relation to important lifestyle factors. This will allow us to better understand the processes influencing the brain as it ages. In turn, this will help identify specific ways to promote healthy brain aging and, perhaps, prevent the onset of Alzheimer's disease.

Participants complete 4 visits over several months. The first visit entails a clinical evaluation and memory testing involving the use of paper and pencil testing. The second visit is an MRI brain scan which lasts approximately one hour. The third visit involves drawing blood for laboratory testing and blood banking for future lab studies, lasting roughly 4 hours. The glucose tolerance test is administered. The fourth and final visit is an assessment of the participant's metabolism and exercise testing. This visit lasts approximately two hours.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years or older
* Healthy male or female
* Normal control volunteers and early Alzheimer's disease patients
* Clinical Dementia Rating of 0, 0.5, or 1.0
* On stable doses of medications

Exclusion Criteria:

* Unstable angina
* Schizophrenia
* Clinical signs of depression; major depression; mental health disorder; nervous system disorder
* Significant visual/auditory impairment
* Significant system illness; cancer
* Pacemaker/metal
* Thyroid problems
* Kidney dialysis
* Organ transplant
* Alcoholism
* Heart surgery
* Insulin
Comparison of Myocardial Infarction Patients Who Were Prescribed a Novel Antiplatelet Agent or Clopidogrel

Myocardial infarction is defined according to icd-10 using the data base of South korea National Health Insurance Corporation, where personal identification information has already been removed, and detailed results are derived for each drug category.

The purpose of this study is to compare the prognosis of patients with clopidogrel after early discontinuation of ticagrelor/prasugrel with patients who maintained aspirin and ticagrelor/prasugrel as standard therapy in patients with acute myocardial infarction who underwent percutaneous coronary intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have a diagnosis code for acute myocardial infarction indicated in the National Health Insurance data and data for drugs that have used ticagrelor/prasugrel for 30-90 days when hospitalized for the relevant disease.
* Patients who switched to clopidogrel after 30-90 days.
* Patients with a diagnosis code for Venus myocardial infarction and a prescription code for percutaneous cardiovascular intervention in the National Health Insurance data.
* Adults 18 years of age or older

Exclusion Criteria:

* A person who has data for requesting blood transfusion during the period of hospitalization in the National Health Insurance data
* Those who have data for oral anticoagulants (warfarin, Coumadin, apixaban, edoxaban, dabigatran, rivaroxaban) in the National Health Insurance data
* Those who have a diagnosis code for malignant tumor in the National Health Insurance data
* Those who have end-stage renal failure code in the National Health Insurance data or those who have data for hemo/peritoneal dialysis
* A person who has a request for blood transfusion during the period of using Ticagrelor/prasugrel
The Effect of SAAE on Ventricular Remodeling in PA Patients

The study aims to assess the effect of superselective adrenal arterial embolization on ventricular remodeling in primary aldosteronism without lateralized aldosterone secretion by comparing it with spironolactone therapy.

After being informed about the study and potential risks,all patients giving written informedconsent will undergo a 2-week screening period to determine eligibility for study entry.Atweek 0,patients who meet the eligibility requirements will be randomized in a 1:1 ratio to Superselective adrenal arterial embolization group or spironolactone therapy group.

Eligibility Criteria:
Inclusion Criteria:

* (1) Age 18-60 years old, regardless of gender;
* (2) Blood pressure conditions meet one of the following: 1) Office blood pressure ≥ 140/90mmHg; 2) Ambulatory blood pressure monitoring whole day blood pressure \> 130/80 mmHg or daytime blood pressure \> 135/85 mmHg;
* (3) After strict drug elution, it met the diagnostic criteria of primary aldosteronism, and bilateral primary aldosteronism was confirmed by adrenal venous sampling;
* (4) No surgical intent or contraindication to surgery and willing to undergo pharmacological treatment or percutaneous superselective adrenal artery embolization;
* (5) The patient or his/her legal representative shall sign the written informed consent approved by the ethics committee before the screening.

Exclusion Criteria:

* (1) Primary hypertension or secondary hypertension with other causes;
* (2) A woman who is pregnant or lactating, or has a birth plan for the next year;
* (3) There are serious organic diseases, especially liver and kidney dysfunction(eGFR\<45 mL/min/1.73 m2);
* (4) Severe allergy to contrast medium;
* (5) Other serious organic diseases, life expectancy \< 12 months;
* (6) Adrenal CT showed adenoma.;
* (7) Patients are enrolled or want to participate in other clinical studies. During the enrollment study, the results of this study will be affected.
Effect of a Patient Education in Pain Coping for Patients Scheduled for Total Knee Arthroplasty

The aim of this study is to investigate, whether a patient education with focus on pain coping is able to improve physical function and experienced pain level in patients with high levels of pain catastrophizing before Total Knee Arthroplasty. Resent studies indicates that these patients do not achieve a satisfactory pain relief and physical function after TKA. Furthermore, the aim is to determine if there is a difference in physical activity and muscle mass among patients with high levels of pain catastrophizing compared to patients with low levels of pain catastrophizing.

In Denmark, are approximately 8000 patients operated annually with Knee Arthroplasty. Most of these patients will have less pain and higher functional ability after the surgery. However, some patients respond poorly to the surgery and approximately 20% of the patients report persistent function-limiting pain six months or more following a total knee arthroplasty (TKA).

Research has shown that patients with high pain catastrophizing scores are at higher risk of having persistent pain and lower physical function after the operation.

This study consists of two parts. The first part is a randomised controlled trial where 56 patients with high levels of pain catastrophizing before TKA are randomised to either treatment as usual (control group 1), which implies surgery and the standard postoperative rehabilitation, or in addition to this, a patient education focusing on pain behaviour and pain coping (patient education). In the second part the patients in control group 1 will be matched on age, BMI and gender with additionally 28 patients with a low levels of pain catastrophizing (control group 2).

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Inability to understand and communicate with the investigators
* Scheduled for an elective unilateral total knee arthroplasty
* Primary diagnosis of osteoarthritis
* Score greater than 22 or lower than 12 on the Pain Catastrophizing Scale (PCS)

Exclusion Criteria:

* Planned to undergo another elective joint replacement procedure during the 12 months period of participation
* Scheduled for revision arthroplasty surgery
* TKA surgery scheduled because of fracture, malignancy or infection
* Scheduled for Unicompartmental knee arthroplasty
* Major depression diagnosed with the Major Depression Index (MDI)
Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit

As medicine advances, many lives can be saved in the intensive care unit. However, when multiple organ failure occurs, the mortality rate of patients increases dramatically. Therefore, the major goal in the intensive care unit is to prevent the occurrence of multiple organ failure. The sepsis protocol and early goal directed treatment have great effects to reduce development of multiple organ failure and to decrease the mortality rate. However, sometime the condition of patient deteriorated in spite of both the mean blood pressure and mixed venous oxygen saturation are normal. Some experts recognize that there might be microcirculatory dysfunction of tissue or organ. The dysfunction of microcirculation might due to vasoconstriction or microthrombosis. Vasoconstriction might result from systemic inflammation, reactive oxygen species, or dysfunction of synthesis of NO (nitric oxide). Microthrombosis might result from systemic inflammation, reactive oxygen species, imbalance of coagulatory system, or damage of endothelial cell.

In clinical practice, the oxidative stress is related to circulatory shock, sepsis, acute lung injury, and acute respiratory distress syndrome. This study tries to investigate the relation between oxidative stress and microcirculation. Furthermore, the investigators will try to investigate the correlation between the severity of oxidative stress and microcirculatory dysfunction and the severity of disease and prognosis. The investigators hope this study will help them to figure out the picture of disease progression of patients. It may conduct further study to modulate the oxidative stress, to improve the microcirculatory function, and finally to improve the outcome of patients.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 y/o
* Related diagnosis made within 24h
* Group 1 - Sepsis
* Group 2 - Postoperative care
* Group 3 - ARDS
* Group 4 - Renal failure
* Group 5 - Liver failure
* Group 6 - Brain death

Exclusion Criteria:

* Pregnant patients
* Related diagnosis made longer than 24h
* Patients who have received antioxidants within 24h
* Patients who have received hyperbaric oxygen therapy
* Patients who have a hemoglobin value less than 9 g/dl
* Patients who have received NO
Observational Study for the Evaluation of Incidence of Systemic Mastocytosis in t(8;21) Acute Myeloid Leukemia

The observational study aimed at evaluating the incidence of systemic mastocytosis associated with t(8;21) AML in patients with de novo t(8;21) AML and their responses to first induction, and the prognosis from standard therapy.

This is a multicenter, retrospective and prospective, observational study that aims to collect clinical information on patients with systemic mastocytosis associated with t(8;21) AML from September 2022 to August 2023. No intervention is expected.

The purpose of this study is to identify and characterize the patients with systemic mastocytosis associated with t(8;21) AML, t(8;21) AML without systemic mastocytosis, and OSM (Oligo-mastocytic SM) with associated t(8;21) AML.

In order to estimate the incidence of systemic mastocytosis associated with t(8;21) AML, a survey will be sent every month to all participating sites to collect the number of all diagnoses of systemic mastocytosis associated with t(8;21) AML, t(8;21) AML without systemic mastocytosis, and OSM with associated t(8;21) AML. All patients will be followed until August 2025 in order to have at least 2 years of observation.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, Age (years) \>= 5;
2. Newly diagnosed as t(8;21) AML patients according to World Health Organization (WHO) classification;
3. Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.

Exclusion Criteria:

1. The t(8;21) AML patients with SM have been diagnosed already;
2. Patients with drug abuse or long-term alcoholism that affected the evaluation of trial results;
3. Patients were deemed unsuitable for enrolment by the investigator.
Iressa v BSC (Best Supportive Care) in First Line NSCLC

The purpose of the study is to determine if the addition of Iressa to Best Supportive Care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage IIIB or IV NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed NSCLC
* NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
* Not suitable for chemotherapy
* WHO Performance status 2 or 3

Exclusion Criteria:

* Newly diagnosed CNS mets
* Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity
* Other co-existing malignancies
* ALT/AST greater than 5 x upper limit of normal
* ANC less than 1.0 x 109/L or platelets less than 100 x 109/L
Emotional Competence and Compassion Online-Training

In this study two different online-courses about emotional competence and compassion are scientifically evaluated with psychometric questionnaires and heart rate variability measuring.

Stress and stress related diseases are becoming a huge health burden in modern societies. Psycho-emotional stress plays a key role in stress regulation. Therefore this study aims to investigate the effects of online-courses addressing emotion regulation.

For this aim several different online-courses about emotional competence and compassion are scientifically evaluated with psychometric questionnaires and heart rate variability measuring. The courses are planned by the trainers and people register on their own initiative.

The courses have a duration of 4 weeks or three months. They consist of video lectures that explain the content as well as videos giving exercises about the character of the different feelings and about the characteristics of emotions. They teach practices on how to use feelings as an empowering force in life and how to deal with difficult emotions.

Eligibility Criteria:
Inclusion Criteria:

* 18-85 years
* participation in one of the included courses
* e-mail address

Exclusion Criteria:

* participation in another study
* no verbal communication (german) possible
* dementia or another disease that limits cognitive abilities