cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Fatigue in Hemodialysis Patients

The prevalence of end stage renal disease in Taiwan was listed first all over the world. Fatigue, which makes patients unable to be competitive to play their functional roles, is one of the most bothersome symptoms of patients receiving long-term hemodialysis. Tracing back to the development of its relating studies, there is no accurate reason that why does people undergoing hemodialysis feel fatigued. Conclusive predictors of fatigue are still not shown up yet. Paper review indicated that the level of L-Carnitine concentration, which affect metabolism of fatty acid, had correlation with fatigue and muscle strength in this population. The serum concentration of L-Carnitine is influenced a lot by hemodialysis. When there is deficiency of energy supply, it resulted to decline of muscle strength, which increased frequency and intensity of fatigue. Hence, the purposes of this study are (1) to understand the basic condition of fatigue level, muscle and metabolism of fat and carbohydrate among hemodialysis patients, (2) to analyze correlation among muscle strength, metabolism of fat/carbohydrate, and fatigue, and (3) to understand correlations among demographic characteristics, blood test data (hemoglobin, albumin, Kt/V, urea reduction ratio(URR), blood urea nitrogen(BUN), creatinine, calcium, phosphorus, and C-reactive protein), mental and social conditions (depression, anxiety, and social support), muscle strength and fatigue, seeking further exploring predictors of muscle strength and fatigue.

The study use cross-sectional descriptive correlative design with consecutive sampling. Recruit patients from a hemodialysis unit in a medical center in north Taiwan after informed- consent. The estimated sample size is 100. To understand relationship among muscle strength, by-products of fatty acid and carbohydrate and fatigue, we collect data by measuring their muscle strength (handgrip and 30 seconds sit-to-stand), and analyzing blood test data and the structured questionnaires which included mental/social data (depression, anxiety, social support and fatigue level). Descriptive statistics, ANOVA, Pearson's correlation, Spearsman's rank correlation and stepwise regression were used to analyze the collected data. Hope this research can get advance in comprehension of cause of fatigue and improve the fatigue symptom of hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* 1.Hemodialysis Patients 2.Aged above 20 3.Consciousness: oriented

Exclusion Criteria:

* 1. Unable to complete muscle strength test or questionnaire
Efficacy of Angiolite Stent vs a Second-generation Drug-eluting Stent Xience for Percutaneous Coronary Intervention

Clinical trial with an "European Community marked" medical device in patients with ischemic heart disease and clinical indication of coronary revascularization with drug-eluting stent.

Clinical follow-up will be done according to this way: first month telephone or face-to-face interview and at 6 ± 1 month an Angiography follow up + OCT (optical coherence tomography)

A randomized clinical trial to compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent.(non-inferiority design)


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical or subclinical ischemic heart disease with indication of percutaneous revascularization.
* "De Novo" lesions ≥ 70%
* Reference diameters ≥ 2 mm and ≤ 4 mm Accepted participation in the registration with the signing of informed consent

Exclusion Criteria:

* Cardiogenic shock
* Pregnancy
* Intolerance or allergy to anti platelet or anticoagulant therapy
* Elective surgical procedure scheduled within 6 months after inclusion in the study
* Expectancy of life of less than 1 year.
* Impossibility of doing 1 year clinical follow-up.
* Primary angioplasty in patients with killip class III-IV or mechanical complications.
* Patient with pre-procedure restenosis.
* Patients who will not be treated all lesions with the Angiolite stent.
* Total occlusions
* Truncus disease
Investigation of Sex Hormone Levels in Chinese Women With Invasive Breast Cancer

This study is to investigate sex hormones levels of Chinese patients with invasive breast cancer.The aim is to analyze biochemical monitoring results of premenopausal and postmenopausal patients to facilitate determination of menopausal status and propose clinical application.

Follicle stimulating hormone (FSH), estradiol (E2) and luteinizing hormone (LH) can serve as indicators in the determination of menopausal status. NCCN clinical practice guidelines for breast cancer recommend detecting the levels of FSH and E2 for amenorrhea patients less than 60 years of age. But the detection method and the corresponding reference ranges indicating postmenopausal status are not mentioned. In addition, the reference limits vary a lot among different equipments and methods when it comes to diagnosis of menopause, thus it is difficult to set universal criteria. So in this study, four widely used methods and instruments in China are used to detect plasma levels of FSH, E2 and LN of premenopausal and postmenopausal patients. Instruments and methods must be one of the following four categories: microparticle chemiluminescent(Beckman),acridinium ester chemiluminescence (Siemens),acridinium ester chemiluminescence (Abbott) and electrochemiluminescence（Roche）.

Eligibility Criteria:
Inclusion Criteria:

* Invasive breast cancer patients confirmed through pathology.
* For postmenopausal group: patients at the age ≥ 60 years with more than one year of menopause, or patients having undergone bilateral oophorectomy.
* For premenopausal group: patients with regular menses during recent 3 months and having never received luteinizing hormone-releasing hormone (LHRH) analogue therapy.
* Patients who meet the above criteria can be enrolled whether they have received anti-cancer treatment or not.

Exclusion Criteria:

* patients less than 60 years old who are amenorrhoeic but have not received bilateral oophorectomy or medical castration.
Behavioral Nudges for Diabetes Prevention (BEGIN) Trial in Primary Care

A large body of research has demonstrated that intensive lifestyle interventions and metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet neither treatment is routinely used in practice. The Behavioral Nudges for Diabetes Prevention (BEGIN) Trial will test two low-touch interventions designed to motivate adoption of these treatments to prevent diabetes. Given that 38% of U.S. adults have prediabetes, the proposed study has potential for large public health impact by testing pragmatic, scalable, and sustainable approaches based in primary care to promote evidence-based treatment for this common condition.

Large randomized trials have found that intensive lifestyle interventions (ILI) and metformin are safe and effective treatment options for promoting modest weight loss and preventing type 2 diabetes (T2D) among adults with prediabetes. However, these treatments are rarely used in practice, and little existing research has focused on patient-centered approaches for promoting their use. One potential approach, behavioral nudges, involves manipulating health messages and treatment options to make behavior change more likely and easier to enact. While a large body of evidence suggests that behavioral nudges are effective, they have not been definitively studied for T2D prevention. The study team will address this critical knowledge gap by conducting the Behavioral Nudges for Diabetes Prevention (BEGIN) Trial. The proposed study will take place in primary care clinics, whose unprecedented reach and regular interaction with prediabetic adults make this an ideal setting for translational T2D prevention research. This definitive study will test two low-touch interventions: 1) prediabetes decision aid intervention consisting of a prediabetes decision aid designed to nudge uptake of evidence-based treatments and delivered by health educators; and 2) text messaging intervention consisting of text messages that deliver similar information and use the same behavioral nudges. The proposed R18 study will accomplish the following specific aims to determine the most effective low-touch intervention that promotes maximal treatment adoption and weight loss.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (aged 18-80 years)
* with prediabetes
* overweight/obesity (BMI ≥25kg/m2)
* patients who speak English or Spanish

Exclusion Criteria:

* type 2 diabetes
* dementia
* serum creatinine \>1.4mg/dL in women and \>1.5mg/dL in men
* current use of oral corticosteroids
* current pregnancy
* uncontrolled hypertension (≥180/100mmHg)
* history of metformin use
* no office visits during the last 12 months
Evaluation of the EF192B Protection Versus No Treatment

This study was designed with the objective of evaluating the protection potential provided by the experimental product EF192B by evaluating its barrier formation capacity. Once its ability to form a barrier is confirmed, EF192B ability to protect against small skin injuries, such as small cuts, bruises, blisters and cracks is confirmed. The barrier formation also guarantees protection against the formation of calluses.


Eligibility Criteria:
Inclusion criteria

* Age between 18 and 70 years old.
* Fitzpatrick skin phototype classification I to IV.
* Presence of intact skin in the test region (right forearm and left forearm for selected participants).
* Agreement to adhere to the study procedures and requirements and attend the institute on the days and times determined for the assessments.
* Signing of the Informed Consent Form (ICF) and the Image Disclosure Consent Form (IDCF) before carrying out any study procedure.

Exclusion Criteria

* Diagnosis of skin diseases such as vitiligo, psoriasis, atopic dermatitis.
* Diagnosis of immunological insufficiency.
* Use of systemic corticosteroids or immunosuppressants.
* Diagnosis of type 1 diabetes mellitus or insulin-dependent diabetes or presence of complications resulting from diabetes (such as retinopathy, nephropathy, neuropathy), presence of diabetes-related dermatoses (such as plantar ulcers, lipoid necrobiosis, granuloma annulare, opportunistic infections), history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma.
* History of reaction to liquid dressings.
* Known hypersensitivity to any ingredients of investigational product formulation.
* Other diseases or use of drugs that may directly interfere with the study or put the research participant's health at risk.
* Presence of any serious or uncontrolled diseases, at the investigator's discretion.
* Pregnancy or lactation.
* Participation in a clinical research protocol in the last 12 months, unless, at the investigator's discretion, their participation in the study may result in direct benefit to the participant.
* Presence of any conditions that, at the investigator's discretion, make the participant unable to participate in the study.
Enhancing Emotion Regulation During Driving in OEF/OIF Veterans

Many U.S. military personnel are returning from Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) deployments with histories of trauma while driving in military vehicles. The proposed project aims to develop and test a rehabilitative technology aimed at enhancing emotion regulation and reducing operator-related risk during civilian driving.

The driving exercises to be used are based upon standard Veterans Affairs-based driver assessments which have a well-established safety record and have been applied to a wide-range of medically-related and post-deployment driving issues.

Specifically, the driving exercises will embed a test-intervene-test session plan within a structured hierarchy of four progressively more challenging civilian driving tasks administered on successive weeks. Participants will drive local roads and highways familiar to Veterans Affairs - Palo Alto Health Care System Certified Driving Rehabilitation Specialists (CDRS). These courses have known characteristics as regards civilian driving challenges and OEF/OIF-relevant "trigger" stimuli. Graduation from one course to the next will take place only with permission from the CDRS who has accompanied the participant on the prior exercise. Based upon their self-reports of driving-related distress, we expect such distress to arise during the driving exercises. At such times, participants will be instructed to park in the next available safe parking location. They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle. These individualized procedures are expected to quickly lower emotional reactivity to subjectively adverse driving events and conditions. The participant will then drive the course a second time. Each session will finish with a graphical comparison of pre- and post-intervention vehicle and control surface movement parameters, visual attentional control, autonomic arousal and subjective driving distress.

Eligibility Criteria:
Inclusion Criteria:

1. Driving-related distress secondary to conditions of OEF/OIF deployment
2. Possesses valid driver's license
3. Owns vehicle registered in his/her name
4. Vehicle currently insured in his/her name
5. Drives regularly (e.g. to regularly scheduled activities such as work or school)
6. Drives to all driving rehabilitation appointments

Exclusion Criteria:

1. Any moving violations since discharge from the military
2. Any central nervous system injury or disease
3. Psychotic disorder and/or any psychotic signs or symptoms
4. Current alcohol or substance abuse/dependence (required answer: "yes" or "no", only)
5. Severe Post-traumatic Stress Disorder (as indicated by a PTSD Checklist (PCL) score greater than 60)
6. Severe Depression(as indicated by a Beck Depression Inventory-II score greater than 28)
7. Amputation or restricted mobility of any limb
Phase 2a Randomized, Double-Blind Study of Oleoyl-Estrone in Male Morbidly Obese Adults

Multi-center, multiple-dose, randomized, double-blind, three-arm, placebo-controlled study of fixed-dose repeated oral dosing for 30 days of 10 mg and 30 mg MP-101 and placebo in obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is willing and able to provide signed informed consent.
* Subject is a male and is between 18-60 years of age.
* Subject is obese as defined as a BMI of 40 - 55.
* Subject is reasonably healthy and have a reasonably acceptable medical history
* Subject has a stable weight for the past 30 days per subject report.
* Subject who has at least one factor of the metabolic
* Subject exhibits stable behavior patterns with regard to smoking and exercise
* Subject can read, speak and write the English language and agrees to follow study procedures.

Exclusion Criteria:

* Subjects who have received any investigational medication within 3 months prior to administration of study drug
* Subjects with confirmed positive results of UDS or Alcohol
* Subjects who are unwilling to return to the clinical research center on specified days during the treatment periods.
* Subjects who have taken exclusionary medication
* Subjects with any clinically significant laboratory abnormality or illness which, in the opinion of the Investigator, would contraindicate study participation
* Subjects who have a history of testing positive for Hepatitis B virus, Hepatitis C virus, or HIV.
* Subject has been involved in a formal or informal (self-imposed) diet regimen within the last 30 days.
* Subject has a confirmed diagnosis or history of cancer, with the exception of nonmelanoma skin cancer.
* Subject is otherwise unsuitable for the study, in the opinion of the investigator.
Study of SyB C-1101 in Patients With Myelodysplastic Syndrome

To assess tolerability of SyB C-1101 when administered orally BID for 21 days followed by a 7-day observation period in patients with recurrent/relapsed or refractory myelodysplastic syndrome in order to determine a recommended dose (RD). To assess safety, efficacy and pharmacokinetics.


Eligibility Criteria:
Patients who meet all of the following criteria are eligible for enrollment in the study:

1. Histologically or cytologically diagnosed as myelodysplastic syndrome (MDS) according to WHO criteria or FAB classification. For patients with RAEB in transformation (RAEB-t), peripheral WBC is ≦25,000 /mm3 and the disease is stable for at least 4 weeks.
2. Classified as Intermediate-1, Intermediate-2 or High-risk, according to IPSS classification.
3. Patients with a history of previous treatment of the target disease (e.g., immunosuppressive therapy, protein anabolic steroids, and chemotherapy including azacitidine and lenalidomide) and meet one of the followings:

   * Patients who failed to achieve complete remission, partial remission, or hematologic improvement\*
   * Patients experienced with recurrence/relapse after achieving complete remission, partial remission, or hematologic improvement\*
   * Patients who were intolerable to the previous therapy \*: The most recent assessment of the therapeutic effect based on "Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia" (IWG2006 criteria)
4. Off all other treatment (including erythropoiesis stimulating agents) for MDS, for at least 4 weeks prior to enrollment and no carry-over (of antitumor effect) from previous treatment is expected as judged by Investigator. Transfusion is allowed, as clinically indicated.
5. Patients with expected survival of ≥3 months.
6. Patients aged 20 years or older (at the time of informed consent).
7. ECOG Performance Status (PS) of 0, 1 or 2
8. Patients with adequate major organ functions (including the heart, lungs, liver, and kidneys).

   * AST (GOT): ≤2.5 -fold the upper limit of normal range at each institution
   * ALT (GPT) : ≤2.5 -fold the upper limit of normal range at each institution
   * Total bilirubin: \<2.0 mg/dL (except patients with Gilbert's disease or hemolysis)
   * Serum creatinine: \<2.0 mg/dL
   * ECG: Absence of abnormal findings that require treatment
   * Echocardiography: Absence of abnormal findings that require treatment
9. The patient must sign an informed consent form indicating that s/he understands the purpose of and procedure required for the study and is willing to participate in the study.
CoreValve™ Evolut R™ FORWARD Study

Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

The study objective is to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

Prospective, single arm, multi-center, observational, post market study. In Australia and Canada it is a prospective, single arm, multi-center pre-market study.

Up to 60 centers worldwide. Geographies may include Europe, Australia, Middle East and Africa, Latin America and Canada.

Approximately 1000 implanted subjects, consented for follow-up through three years.

For each subject, data will be collected preoperatively, intra-operatively, at hospital discharge, 30 days, 1, 2 and 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement
* Acceptable candidate for elective treatment with the Evolut R System and in conformity with the local regulatory and medico economic context
* Age ≥80 years OR considered to be at high or greater risk for surgical aortic valve replacement (AVR) where high risk is defined as:

  * Society of Thoracic Surgeons (STS) predicted risk of mortality ≥8% OR
  * Documented heart team agreement of risk for AVR due to frailty or comorbidities.
* Geographically stable and willing to return to the implanting site for all follow-up visits
* Of legal age to provide informed consent (patient Informed Consent or Data Release Form) in the country where they enroll in the trial
* The patient has been informed of the nature of the study, is able and willing to provide consent without assistance from a legal representative and has consented to participate, and has authorized the collection and release of his/her medical information by signing a Patient Informed Consent or Data Release Form.

Exclusion Criteria:

* Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated
* Preexisting mechanical heart valve in aortic position
* Ongoing sepsis, including active endocarditis
* Anatomically not suitable for the Evolut R system
* Estimated life expectancy of less than 1 year
* Participating in another trial that may influence the outcome of this trial
* Need for emergency surgery for any reason
Sunitinib Treatment on Tissue Sodium Accumulation (TSS2)

Here, it is investigated how sunitinib, a tyrosine kinase-inhibitor targeting vascular endothelial growth factor receptors, might influence sodium homeostasis in the skin and if this is related to a well-described treatment side-effect of sunitinib, hypertension.

Tyrosine kinases-inhibitors targeting vascular endothelial growth factor (VEGF)-receptors (RTKIs) are increasingly used in oncology in several metastatic tumor types. These agents are featured by toxicities including hypertension. According to a new insight, sodium in response to a high dietary sodium intake, is accumulated in a hyperosmolar way in the interstitial compartment. In response to this high sodium concentration cells of the mononuclear phagocytic system (MPS) are activated resulting in an increased production of VEGF-C, activation of VEGF type 3 receptors and formation of a lymphatic capillary network, involved in clearance of interstitial sodium. Blockade of stimulation of VEGF-C receptors or depletion of MPS cells in rodents has been associated with salt-sensitive hypertension.

Sunitinib is an orally-active, multitarget RTKI mainly used for the treatment of patients with metastatic renal cancer and imatinib-resistant gastrointestinal stromal tumors. Sunitinib blocks all three VEGF receptors subtypes, including VEGF-receptor type 3.

The investigators hypothesize that treatment of patients with sunitinib is associated with tissue sodium accumulation and this accumulation contributes to the rise in blood pressure. Tissue sodium is measured by using a newly developed 23Na magnetic resonance-imaging (MRI) technique which allows a non-invasive and contrast agent-free sodium content measurement in the muscle and skin of the lower leg.

Eligibility Criteria:
Inclusion Criteria:

* Age men \> 18 years
* Life-expectation \> 3 months
* Stable weight
* Blood pressure below 140/90 mmHg at baseline
* Estimated glomerular filtration rate \> 45 ml/min/1.73m2
* Willingness to give written informed consent

Exclusion Criteria:

* Heart failure
* Liver disease with ascites
* Nephrotic syndrome
* Gastrointestinal complaints, preventing normal daily food intake or diarrhea
* Any form of diabetes mellitus
* Known autoimmune diseases
* Acute or chronic infection
* Alcohol or substance abuse