cyrilzakka/clinical-trials huggingface dataset:
Fludarabine and Cytarabine as Continuous Infusion Plus G-CSF Priming for Elderly Patients With Resistant AML

* To determine the feasibility of fludarabine and cytarabine as continuous infusion plus granulocyte-colony stimulating factor priming for elderly patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia
* The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.

* A second course of induction chemotherapy can be given to the patient when a partial remission but less than a complete remission is achieved after the first course. At least 4 weeks should be apart between start of the first course and start of the second course.
* G-CSF (Lenograstim) 250 g/day will begin to be administered after the confirmation of hypocellular bone marrow with blasts less than 5% on day 14 or later until absolute neutrophil counts are 1,000/l or more.
* For the patients who achieve a complete remission, consolidation therapy will be given as follows:

  * Two more cycles of the same chemotherapy will be given to the patients who achieve a complete remission after single induction course. Allogeneic or autologous hematopoietic cell transplantation could be also considered.
  * In patients who relapse after allogeneic hematopoietic cell transplantation, donor leukocyte infusion will be done without consolidation chemotherapy.
  * In patients who had extramedullary relapse(s), local radiotherapy can be given to the relapse site(s).

Eligibility Criteria:
Inclusion Criteria:

* Failure to achieve CR after initial induction chemotherapy
* Any relapse, regardless of the frequency and time of relapse from first CR
* Relapse after hematopoietic cell transplantation, allogeneic or autologous.
* Multiple relapses, extramedullary relapse(s)

Exclusion Criteria:

* Inadequate hepatic,renal,cardiac function
* Psychiatric disorder or mental deficiency
* CNS involvement of leukemic blasts
Evaluation of the Effects of Rehabilitation Using the "Wii" on Upper Limb Kinematics in Chronic Stroke Patients.

The purpose of this study is to evaluate changes in strategies of hemiparetic upper limb movement in chronic stroke patients following rehabilitation using the "Nintendo Wii". The investigators hypothesize that patients will increase their use of compensatory strategies following this rehabilitation.

The principal aim of this study is to evaluate changes in strategies of hemiparetic upper limb movement in chronic stroke patients following twelve one hour sessions of rehabilitation using the "Nintendo Wii" over a period of four weeks, and to compare with a group of patients receiving traditional upper limb rehabilitation of the same duration. The investigators hypothesize that the use of compensatory strategies will increase in the group receiving the "Wii" rehabilitation while they will decrease in the group receiving traditional rehabilitation. The investigators further hypothesize that this will have an impact on the functional benefit with a greater improvement of function in the group receiving traditional rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

Age 18 to 75 years Right handed Hemiparesis following vascular lesions of a single hemisphere of more than 6 months duration.

Not a regular 'Wii' user Able to bring the hand to the mouth. No botulinum toxin injections within the previous 3 months Having given informed consent

Exclusion Criteria:

Major cognitive or perceptive deficits Cerebellar syndrome Epileptic fits within the previous year Pacemaker user Un-corrected visual deficits No social security
Using Thoracic Ultrasound to Predict Pleurodesis Success in Malignant Pleural Effusions: a Pilot Study

The observational pilot study at the Churchill Hospital, funded by Oxford Respiratory Trials Unit, will assess the feasibility and efficacy of thoracic ultrasound (TUS) assessment in patients undergoing talc pleurodesis via intercostal chest drain (ICD) for recurrent symptomatic malignant pleural effusions (MPE). Participants will undergo TUS pre and post pleurodesis on up to four occasions. We hypothesise that a TUS scoring system will be able to predict short and long-term pleurodesis success earlier than current conventional medical practice allows. This study may ultimately allow the proposal of a treatment algorithm to manage patients with MPE in a more efficient manner.


Eligibility Criteria:
Inclusion Criteria:

* The participant is willing and able to give informed consent for participation in the study.
* Adult male or female, aged 18 years or above.
* Diagnosed with a malignant pleural effusion requiring intercostal chest drain insertion and subsequent talc slurry pleurodesis for symptom relief and/or other therapeutic purposes as part of routine clinical care.

Exclusion Criteria:

* Age less than 18 years.
* Inability to provide informed consent
* Known hypersensitivity/allergy to medical talc, or other contraindication to the administration of intrapleural talc, as determined by the responsible clinician.
* Evidence of significant trapped lung that would prevent pleurodesis being performed, as determined by the clinician responsible for assessing the patient.
* Expected survival of less than one month due to underlying co-morbidities.
Mi-thos® Transcatheter Mitral Valve Replacement Study

To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.

The Mi-thos® study is an multicenter, single-arm, prospective, safety and performance clinical study.

Eligibility Criteria:
Inclusion Criteria:

* Severe mitral valve regurgitation ≥ 3+;
* High surgical risk fot open mitral valve surgery;
* Age ≥ 65 years old;
* Life expectancy \> 12 months;
* As assessed by multidisciplinary cardiac team, patients who are not eligible for surgery;
* Patients sign an informed consent form.

Exclusion Criteria:

* Previous cardiac mitral valve surgery;
* Active infections requiring antibiotic therapy;
* Clinically significant untreated Coronary Artery Disease (CAD);
* Pulmonary hypertension （Pulmonary systolic pressure \> 70 mmHg）;
* Patients with severe right heart failure;
* Left ventricular ejection fraction \<25%;
* Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;
* Dialysis patient;
* Patients with severe coagulopathy;
* Patients with contraindications to anticoagulant drugs;
* Patients with stroke or transient ischemic within 30 days;
* Echocardiography found any intracardiac mass, left ventricle or atrial thrombus;
* Patients who require surgery or interventional therapy for other valvular lesions;
* Patients with severe macrovascular disease requiring surgical treatment;
* Patients with more than 70% of carotid stenosis;
* To be allergic to contrast agents, nickel-titanium memory alloys or bovine-derived products;
* Patients with severe neurological disorders affecting cognitive ability;
* Patients with severe thoracic deformities.
Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder

Aim of this study is to evaluate the efficacy and safety of a range of doses of tamsulosin hydrochloride as treatment in children with an elevated detrusor leak point pressure associated with a known neurological deficit


Eligibility Criteria:
Inclusion Criteria:

* Neuropathic bladder secondary to a known neurologic deficit (e.g. spina bifida)
* Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements

Exclusion Criteria:

* Clinically significant abnormalities as determined by the investigator
* A history of relevant orthostatic hypotension, fainting spells or blackouts
Adolescent Responses to Varying Environments in Virtual Reality Simulations

The objective of this study, named THRIVE (The Research In Virtual Environments Study), is to test hypotheses for how neighborhood environments influence stress and emotion, as a mechanism by which they may influence health. Neighborhood environments may have both acute influences on stress-related processes, but also may have lifespan effects due to the chronic, cumulative effects of repeated exposures and the long-term toll of adapting to adverse neighborhood environments. However, assessing neighborhood influences on stress and emotion is methodologically challenging. This study develops such a novel, alternative approach to address these questions by deploying a virtual reality (VR) based model of neighborhood disadvantage and affluence that creates an immersive experience approximating the experience of being in different neighborhoods. In this study, this model will be applied to understand neighborhood effects in a diverse sample of adolescents (n = 130) from a range of disadvantaged and affluent neighborhoods. The proposed study will employ a randomized experiment (n = 65 per condition), with online questionnaires and a single study session, to determine (a) if virtual exposure to neighborhood disadvantage elicits differences in emotion and stress reactivity; (2) if growing up in a disadvantaged neighborhood results in habituation or sensitization to different neighborhood characteristics; and (3) if chronic stress results in habituation or sensitization to different neighborhood characteristics. This research will develop an innovative methodology that will help establish the role that neighborhoods may play in eliciting stress as well as the processes of adaptation to chronic stress and chronic neighborhood exposures. In addition, it will help establish a method that can be utilized more broadly to study contextual and social environmental influences on psychological and biological risk in adolescence.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Are able to use a dominant hand for joystick manipulation and a non- dominant hand for physiological measurements,
* Are in good physical and mental health, with no self-reported history of hypertension, cardiovascular disease (CVD) or CVD treatment (with associated medication list indicative of treatments that result in exclusion),
* Have hair at least 1cm in length based on self-report to be able to provide a hair sample.

Exclusion Criteria:

* Pregnant, by self-report
iNav-based, Automated Coronary Magnetic Resonance Angiography for the Detection of Coronary Artery Stenosis

Ischaemic Heart Disease (IHD) is the worlds leading cause of death. IHD is often caused by a narrowing of the coronary arteries, which prevents blood from flowing to the heart muscle, causing pain and damage to the heart. If an individual has a myocardial infarction (MI), parts of the heart that are damaged cannot be repaired. Therefore, it is important to identify and treat the narrowing of the arteries before an MI occurs.

At present there are 2 main methods of identifying narrowing of the arteries. The first is an invasive procedure, the other using a CT scan. Whilst both methods are effective, they entail risk. The invasive procedure can damage the coronary arteries, whilst the CT scan exposes patients to radiation and contrast, which can increase the risk of cancer and allergic reactions.

Magnetic Resonance (MR) scanning is an alternative to these methods, but it has been limited in use in the past due, in part, to the high technical knowledge required to obtain images. In addition, there is a degree of subjectivity in the selection of the mid-diastolic rest period, potentially affecting consistency of results. This means it is difficult to use in a day-to-day hospital environment. However, recent technological developments using artificial intelligence mean that images can be acquired in a more automated and consistent fashion. This new scan has yet to be tested in a clinical trial.

Therefore, the objective of the clinical study is to test this new scan to determine its efficacy. 230 patients at 5 sites at risk of coronary artery disease, who have been referred for invasive coronary angiography, will undergo both their angiography and the new MR scan. The MR scan will then be compared to CCTA for diagnostic accuracy and image quality.

The investigators hypothesise that the new MR scan will have the same diagnostic accuracy as invasive coronary angiography, with no differences in interpretation of the images across the 5 different hospitals.

If proven effective, this would demonstrate that MR scanning of the coronary arteries could prove a safe, clinically useful alternative to both CT scanning and invasive assessment of coronary artery narrowing. In addition, if there is no difference across different locations, it would demonstrate that these scans can be performed consistently, facilitating implementation on a healthcare-system wide basis.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:
* ≥18 years old
* Subject has provided informed written consent
* BMI \< 35
* Sinus Rhythm
* Stable symptom at time of inclusion
* Undergoing CCTA within 28 days

Exclusion Criteria:

* Any contraindication to CMR
* Previous coronary revascularisation
* Inability to take sublingual nitroglycerin
* Irregular heart rate
A Pivotal Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With Unknown Diabetes Status and Performance Evaluation of the Glyconics SW Package

The main clinical study objective is to confirm the accuracy of the Glyconics-DS spectrometer when used in its intended medical purpose population, i.e., in individuals with unknown diabetes risk. Additionally, this investigation will serve as a pivotal performance evaluation for the associated software for correct delivery of the algorithm-based analysis of the individual diabetes risk. The study will be considered positive if the backend delivery of the chemometrics output is performed correctly as per the cloud-based analysis and its delivery represents the essential medical software to be evaluated in this investigation. The 'true' diabetes risk will be contrasted against values of an internal biomarker indicative of glycaemia, HbA1c, as measured based on standardised, certified methodology.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy adults (≥18 years of age) with unknown diabetes status willing to participate in and provide a written consent for the study
* Willingness to undertake assisted assessment of glycaemia: by both the NIR spectral measurements in a chosen middle fingernail, and HbA1c (blood sample)
* Individuals with at least one visually assessed undamaged, intact (preferably middle) fingernail.

Exclusion Criteria:

* Individuals with any known medical conditions impacting either of the assessment methodology for glycaemia, such as:

  * Severe forms of anaemia (diagnosed iron deficiency, sickle cell anaemia or similar).
  * Haemoglobinopathies or atypical haemoglobin subtypes not detectable by regular (local) laboratory assays for HbA1c.
  * Severe renal impairment (CKD stage III-IV) or decompensated hepatic disease.
  * Severe Vitamin D deficiency (diagnosed or measured 25(OH)D3 \< 25 nmol/ml).
  * Known severe immunodeficiency such as HIV, malignancy or other chronic condition significantly impacting assessment of glycaemia.
  * Eating disorders (as per clinical assessment)
  * Recent (within 28 days) blood donation
  * Any other type of known diabetes than T2DM, if diagnosed (T1DM, GDM, MODY, etc.)
* Any structural, deviating and visually detectable deviations in the appearance of the (only/ to be assessed) middle fingernail potentially impacting the spectra measurement, including:

  * nail dystrophy or deformity
  * severe nail infections (onychomycosis causing visual changes in the appearance of the nail).
  * rare hereditable conditions impacting the structure of keratin.
  * mechanical damage or marks on the surface of the nail after removal of nail polish.
  * use of acrylic or gel nail decoration and polish, which cannot be removed with acetone (use of acetone necessitates a 15 min post-removal wash-out time)
* Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value.
PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes EGFR Mutation-Positive NSCLC

The objectives of this study are to assess molecular testing, treatment patterns, and associated outcomes among patients with EGFR (Epidermal Growth Factor Receptor) mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have progressed on or after EGFR-TKI (EGFR-Tyrosine Kinase Inhibitor) therapy post availability of a third-generation TKI (primary study cohort). Additionally, molecular testing and treatment patterns will be assessed among a secondary cohort of patients which will include patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC.


Eligibility Criteria:
Inclusion Criteria - Primary Study Cohort

* Provision of written informed consent (patient consent should be within 6 weeks of disease progression, defined elsewhere as the Index Date)
* Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)
* Patients with prior confirmed EGFR mutation-positive (all mutations) locally advanced or advanced NSCLC - Patients who developed resistance to an EGFR-TKI due to any other phenotypic/histologic transformations (e.g., small-cell lung cancer, EMT) or other mutations (e.g., HER2, MET amplifications) at the index-date will be eligible for participation in this study as long as they have prior confirmed diagnosis of EGFR mutation-positive (all mutations) locally advanced or advanced NSCLC
* Patients who have progressed on or after EGFR-TKI therapy (i.e., gefitinib, erlotinib or afatinib) within the patient selection period

Inclusion Criteria - Secondary Study Cohort

* Provision of written informed consent (patient consent should be within 6 weeks of NSCLC diagnosis, defined elsewhere as the Index Date)
* Adult male or female subjects (according to age of majority/adulthood as defined by local regulations)
* Patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC during the patient selection period. The de-novo T790M mutation can be alone or in combination with other mutations (e.g., L858R and T790M).

Exclusion Criteria - Primary and Secondary Study Cohorts

• Enrollment in studies that prohibit any participation in this non-interventional study. These patients will be censored.
A Pilot Trial to Determine the Safety and Efficacy of Fluvastatin in Previous Partial Responders to Pegylated Interferon and Ribivirin in Patients With Genotype 1 Hepatitis C

This study seeks to evaluate the safety and efficacy of taking fluvastatin along with peginterferon alfa in previous partial responders with genotype 1 HCV.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of any ethnicity age 18 - 65 years with genotype 1 HCV
* Previous partial responder to attempts at HCV therapy with PEG/RBV (at least 1 log drop but less than 2 log drop in HCV RNA at 12 weeks)
* Previous history or serum HCV-RNA PCR quantifiable by Roche Amplicore HCV Test
* A liver biopsy within 3 years of study enrollment consistent with HCV disease.
* Compensated liver disease, Child-Pugh Class ≤ 6
* Negative urine pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the study drug
* All patients enrolling in the study and all partners of study participants of childbearing potential must be using two reliable forms of effective contraception during the study. Exceptions may include partner/participant is surgically sterile.
* Willingness to comply with study procedures and provide written informed consent

Exclusion Criteria:

* AST or ALT \> 10 ULN
* Any investigational drug ≤ 12 weeks prior to the first of study drug
* Prior intolerance to statin medications
* Previous serious side effects to IFN or RBV (e.g. psychiatric side effect necessitating treatment discontinuation, severe cytopenia refractory to growth factors, intolerance to IFN/RBV requiring treatment discontinuation)
* Any systemic antiviral therapy ≤ 24 weeks prior to the first dose of study drug or expectation that such treatment will be needed at any time during the study. Exception: Patients who have taken or are expected to require such treatment for herpetic lesions
* Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc-IgM Ab ,or anti-HIV Ab
* Serum concentrations of cerulplamin or alph-1-antitrypsin consistent with an increased risk of metabolic liver disease
* History or other evidence of a medical condition associated with chronic liver disease (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, nonalcoholic steatohepatitis)
* Women who are pregnant or breastfeeding and male partners of woman who are pregnant or breastfeeding
Evaluation of Exercise Benefits to Promote Health Aging Among Chronically Ill Geriatrics in a Community

The aim of this study is to evaluate the effect of hydraulic resistance circuit training for elderly people with chronic illness.

This study is divided into three years. The aim of the first year is to analyze the types and percentage of chronic illness in middle- and old-aged population in communities and the impact on their physical and mental function. The Second year, we will use proper exercise prescriptions with exercise equipment available for chronic illness population and examine the improvement of their physical and mental functions after exercise intervention. The third year, we will adopt the concept of social marketing to promote knowledge about health-related fitness and exercise to communities and help to establish exercise center. To chronic illness people, the study seeks to delay the progression of disease and disability by encouraging them to participate in prescribed exercises. To relatively healthy people, exercise can achieve the purposes of healthy aging, decreased chronic illness, and improved ADLs function and life quality.

Eligibility Criteria:
Inclusion Criteria:

Subjects were recruited at the age of 45-80, and can communicate verbally and in writing.

Exclusion Criteria:

Subjects had physical limitation in sports and were advised not to exercise by doctors.
Comparative Research Among 3 Action Protocol in Other to Approach Chronic Patellar Tendinopathy

The accomplishment of a treatment with Intratissue Percutaneous Electrolysis of additional form to the accomplishment of eccentric exercise's program in patients with chronic patellar tendinopathy is more effective than the accomplishment of an additional treatment with dry needling or eccentric exercise's program realized of isolated form.

Experimental study randomized with double blind, whose purpose is to compare three protocols in those who apply different protocols of physical therapy to themselves in three groups of intervention with patients with chronic patellar tendinopathy.

There take part in this study young women of both sexes, of Zaragoza and of different sports clubs of entity 18 and 40 years, that they realize of habitual form (minimum 3 times a week) a sport. All of them present chronic patellar tendinopathy.

Eligibility Criteria:
Inclusion Criteria:

* Age understood between 18 and 40 years.
* To practise any sport of habitual form.
* Patients diagnosed of chronic patellar tendinopathy with a minimum of 3 months of evolution and with stable symptomatology.
* Pain to the palpation of the tendon in the low pole of the knee and during the training or competition.
* Punctuation of the questionnaire VISA-P under 80.

Exclusion Criteria:

* Patient had an operation on the knee affected in the last 6 months.
* Infiltrations in the knee affected in the last 3 months.
* Patient who has received pharmacological treatment or physical therapy in the last 48 hours.
* Pathology with less than 3 months of evolution.
* To present bilateral chronic tendinopathy.
* Punctuation of the questionnaire major or equal Visa - p of 80.
* Inability to apply someone of the techniques of treatment or valuation for absolute or relative contraindication.