cyrilzakka/clinical-trials huggingface dataset:
Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure

The goal of this clinical trial is to compare physician-guided (SOC) versus nurse-led natriuresis-guided diuretic therapy in patients with acute decompensated heart failure (ADHF). The main questions it aims to answer are:

* difference in natriuresis and diuresis
* feasibility of the protocol.

Participants will be asked to gather two 24 h urine collections.

Researchers will compare SOC versus nurse-led diuretic titration to see if there is a difference in natriuresis after 48 hours.

The EASY-HF study was a single-centre, randomized, open-label study comparing standard of care (SOC) diuretic management at the treating physician's discretion with a nurse-led natriuresis-guided protocol in patients with ADHF. A bedside sensor was used to measure the urinary sodium content.The primary endpoint was total natriuresis after 48 hours. Secondary endpoints included safety profile and user-friendliness of both the protocol and the point-of-care sensor.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Provide written informed consent
* Hospital admission with signs and symptoms of congestion warranting intravenous decongestive therapy
* Congestion score of at least 2 based upon the presence of edema, pleural effusion, or ascites
* N-terminal pro-B-type natriuretic peptide (NT-proBNP) level of at least 500 ng per litre (800 ng per litre in case of atrial fibrillation)

Exclusion Criteria:

* Patients unable to collect a 48h-urine collection
* Estimated GFR below 20 ml/min/1.73m\^2
* Concomitant diagnosis of an acute coronary syndrome
* Need for inotropic or vasopressor support
* Ventricular assist device
* Renal replacement therapy
* Treatment with intravenous loop diuretics \> 80mg furosemide or an equivalence of another loop diuretic (40mg furosemide = 1mg bumetanide) during the index hospitalization and prior to randomization
TAE and MWA Combination Therapy in Early-stage Hepatocellular Carcinoma

This is a single-center, prospective RCT to study the effectiveness of TACE and MWA combination therapy with MWA monotherapy for the treatment of early HCC. Primary outcome is 2-year intrahepatic disease-free survival.

This single-center, prospective randomized controlled trial (RCT) is designed to compare the outcomes and clinicopathologic results of trans arterial embolization (TAE) and microwave ablation (MWA) combination therapy with MWA monotherapy for the treatment of early (stages 0 and A) hepatocellular carcinoma (HCC). The primary aim of this study is to test the following hypothesis: 2-year intrahepatic disease-free survival does not differ between patients receiving the experimental therapy (MWA + TAE) and patients receiving the standard therapy (MWA alone) as treatment for early stage HCC. Secondary aims are: 1) to determine the clinical feasibility of TAE + MWA in HCC patients with a small tumor burden using patient demographics and disease characteristic data and 2) to determine the effect of TAE on radiographic tumor characteristics in this patient cohort.

The primary outcome is 2-year intrahepatic disease-free survival, which is measured from time of randomization and is defined as the absence of local or regional recurrence of HCC as determined by diagnostic imaging. Local recurrence is defined as an enhancing lesion contiguous with the ablation zone that is present on subsequent imaging but was not present on the initial post-ablation scan. Regional recurrence is defined as hepatic recurrence that is not adjacent to the ablation site.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of hepatocellular carcinoma (HCC)
* HCC classification of stage 0 (very early) or stage A (early) according to Barcelona Clinic Liver Cancer (BCLC) staging system criteria
* Adequate clinical condition to undergo laparoscopic or robot-assisted laparoscopic transarterial embolization (TAE) and/or microwave ablation (MWA) as treatment for HCC
* Willing and able to give informed consent

Exclusion Criteria:

* Radiologic (computed tomography or magnetic resonance imaging) evidence of invasion into major portal/hepatic venous branches and no extrahepatic metastases
* Evidence of residual disease at first post-MWA computed tomography examination
* Body Mass Index (BMI) \> 35
* Previous history of hepatic resections
* Severe renal dysfunction (creatinine clearance of \<40 mL/min)
* Pregnant or nursing women
The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

To compare The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old and younger than 75 years;
* ECOG PS\<3;
* proven hepatocellular carcinoma with MVI according pathological examination;
* not previous treated for tumor;
* tumor was removed in operation;
* no recurrence occurence at 4 to 7 weeks after surgery;
* the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin\<3-times upper limit of normal; ALT\<5-times upper limit of normal; AST\<5-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3;
* sign up consent;
* unrolled by other clinical trials about hepatocellular carcinoma.

Exclusion Criteria:

* cannot tolerate TAI;
* CNS or bone metastasis exits;
* known history of other malignancy;
* be allergic to related drugs;
* underwent organ transplantation before;
* be treated before (interferon included);
* known history of HIV infection;
* known history of drug or alcohol abuse;
* have GI hemorreage or cardiac/brain vascular events within 30 days;
* pregnancy;
Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)

The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.


Eligibility Criteria:
Inclusion Criteria

* Has a Rutherford Clinical Category Score of 1 - 6.
* Has evidence of ≥ 50% stenosis or occlusion in the superficial femoral, popliteal, anterior tibial, posterior tibial and/or peroneal arteries, confirmed by angiography.
* Has identifiable distal target vessel which upon completion of the intervention, is anticipated to provide re-constitution of blood flow to the foot.
* Exchangeable guidewire must cross lesion(s), with ability of catheter to cross lesion.
* Each discrete target lesion's length is ≤ 20 cm.
* Reference vessel diameter is ≥ 1.5 mm and ≤ 7 mm.

Exclusion Criteria

* Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure.
* Has any planned surgical intervention or endovascular procedure within 30 days after the index procedure.
* Has had a previous peripheral bypass affecting the target limb.
* Has end-stage renal disease defined as undergoing hemodialysis for kidney failure.
* Has presence of severe calcification in target lesion(s).
* Has in-stent restenosis of the target lesion.
* Has an aneurysmal target vessel.
* Has significant stenosis or occlusion of inflow tract that has not been revascularized prior to treatment of the target vessel.
* Has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment.
* Has disease that precludes safe advancement of the SilverHawk/TurboHawk device to the target lesion(s).
* Has had a previous amputation above the metatarsal line on the target limb.
Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy

The Sponsor values the progression of hearing healthcare practice and acknowledges a need for re-evaluation of indications for determining adult cochlear implant candidacy. This need arises from current research, peer reviewed literature, and technological advancement with concomitant performance outcomes. To address this specifically, the Sponsor proposes to evaluate the safety and efficacy of the Cochlear™ Nucleus® implant system with a revised indication.

Existing research, as discussed, supports the opinion that current candidacy criteria are set conservatively. The Sponsor, in addition to the support of recent peer reviewed literature illustrating a need for an appropriate criteria and more suitable speech recognition measure, believe it is appropriate at this time to re-evaluate the candidacy requirements associated with adult cochlear implantation. Specifically, this will be accomplished by evaluating the safety and efficacy of the Cochlear™ Nucleus® cochlear implant system under revised cochlear implant indications. The proposed approach would be to evaluate individuals scoring between 10 - 40% inclusively on Consonant Nucleus Consonant (CNC) monosyllabic words who do not meet current approved speech perception criteria with the widely used sentence measure Hearing In Noise Test (HINT) in quiet. No change to current qualifying audiometric criteria (bilateral moderate to profound sensorineural hearing loss in the low frequencies and profound hearing loss in the mid to high speech frequencies) for implant candidacy is proposed.

Eligibility Criteria:
Inclusion Criteria:

* Eighteen years of age or older at the time of the study.
* Preoperative aided CNC word score in quiet of greater than or equal to 10% and less than or equal to ¬¬40% in the ear to be implanted; equal to but no better than 50% in the contralateral ear
* Bilateral moderate to profound hearing loss in the low frequencies (up to 1000 Hz) and profound sensorineural hearing loss in the high speech frequencies (3000 Hz and above)
* Willingness to use bimodal stimulation (i.e. a cochlear implant on one ear and a hearing aid on the contralateral ear) through at least 6-months postactivation.
* English spoken as the primary language.

Exclusion Criteria:

* Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
* Preoperative aided HINT sentence score less than or equal to 50% in the ear to be implanted
* Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.
* Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway).
* Active middle-ear infection.
* Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure.
Fetal Alcohol Damage Prevention Study

The goal of this study was to determine whether a series of blood markers of alcohol use obtained from alcohol using pregnant women could help them to change their behavior.

This study involved screening pregnant women with an alcoholism screening questionnaire and obtaining blood from those women who screened positive and a subset of women who screened negative. Each woman who had blood drawn were informed of their results, educated about alcohol use in pregnancy and had a brief intervention about their alcohol use, if appropriate. They were monitored throughout the pregnancy with additional blood tests obtained, depending upon their stage in pregnancy. After birth the babies were examined for any signs of alcohol exposure.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women seen at one of the obstetric clinics in the study and willing to give a blood sample

Exclusion Criteria:

* over 36 week gestation
Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders

The purpose of this study is to determine clinical outcomes related to deactivation of Cardiac Resynchronization Therapy device in subjects with super response.


Eligibility Criteria:
Inclusion Criteria:

* super response to Cardiac Resynchronization Therapy
* near normal Left ventricular ejection fraction
* \>99% pacing

Exclusion Criteria:

* \<99% pacing
* atrial fibrillation
* ischemic cardiomyopathy
Phosphodiesterase (PDE) Inhibitors Effect on Cognitive Deficits Associated to Schizophrenia

Phosphodiesterase (PDE) inhibitors represent a new group of potential antipsychotic compounds currently under development. One of these is papaverine, an inhibitor of the PDE 10 family. The class of PDE10 inhibitors have been reported as possible candidates in the treatment of schizophrenia, and may prove an attractive antipsychotic alternative due to the many side-effects of the currently available antipsychotics. It has been proposed from preclinical studies that PDE10 inhibitors have the potential to reduce cognitive deficits in schizophrenia and these findings need to be confirmed in a human population, in view of the fact that no other currently registered drug posses these unique properties.

The currently proposed project is designed to investigate whether the PDE10 inhibitor Papaverine indeed have the capacity to reduce cognitive deficits in schizophrenia patients. In order to accomplish this effect, Papaverine will be investigated in schizophrenia, with regards to symptomatology, hemodynamic, neurocognition and early information-processing.

The study has a double blind, balanced crossover design. Randomized, half of the subjects will be given Papaverine (PDE10 inhibitor, 300 mg orally) in the first session followed by placebo in the second, and the other half will be treated in the reverse order. There is a minimum of one month between the two test-sessions. After each of the two treatments, the subjects will be tested with both a psychophysiological (the Copenhagen Psychophysiological Test-Battery) and neuropsychological test-battery (tests from the Cambridge Neuropsychological Test Automated Battery, or "CANTAB"). The project has three phases: In the first phase 10 healthy subjects will be included to determine the kinetics of Papaverine-contained release capsules ; in the second phase 30 schizophrenia patients and 30 healthy subjects will be included to determine the impact on cognitive and sensory gating related deficits; Finally 10 Healthy subjects will be included to determine the effect of Papaverine on hemodynamical parameters by the means magnetic resonance scannings.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Schizophrenia (WHO ICD 10)
* Treatment stable (no regulation in medicine for 6 weeks prior)
* Mono antipsychotic treatment
* No regular Antidepressants (PN accepted)
* No regular Benzodiazepines (PN accepted)

Exclusion Criteria:

* Dependence syndrome
* Severe physical illness
* MRI incompatible, non removable objects above shoulders
The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study

The goal of this infrastructure grant is to establish and maintain a cohort of over 12,000 non-Hodgkin lymphoma (NHL) patients to support broad and cutting-edge research that identifies clinical (including co-morbid diseases), epidemiologic (including lifestyle and other exposures), host genetic, tumor, and treatment factors, as well as the interaction among these factors, on short and long-term outcomes. These efforts will identify new approaches to improve the survival and well-being of NHL patients.

Newly diagnosed non-Hodgkin lymphoma (NHL) patients will be recruited from each center participating in the LEO cohort. At time of consent, participants will be asked to completed several questionnaires collecting health history, current medical and quality of life questions. Patients will also provide a baseline blood sample that will processed locally and stored centrally for future research use. Additionally, consent is given for use of excess clinical tumor tissue for research use.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed non-Hodgkin Lymphoma (NHL), within 183 days of enrollment
* Patients may have been treated as long as initial NHL diagnosis is within 6 months of enrollment
* 18 years of age or older

Exclusion Criteria:

* Lymphoma diagnosis greater than 184 days from date of consent
Observer Variability in Scoring Abdominal Aortic Calcifications and Vertebral Morphometry

BACKGROUND In the context of a progressively aging population, monitoring the status of Vascular Calcifications (VC) and Vertebral Fractures (VF) over time would be of primary importance, as VC and VF are recognized to be hallmarks of severe cardiovascular events (hospitalization and/or death) and hip fractures respectively, and VF represent an under-diagnosed cause of progressive disability and pain on its own. Moreover, there is an acknowledged relationships between VC and VF.

However, data about the emergence/progression of VC and the emergence/worsening of VF over time are lacking. This is likely due to the absence of monitoring instruments for VC and VF that are both precise and easily accessible/applicable.

OBJECTIVE This study aims to define the observer variability of a new software developed by the study sponsor and collaborators, called Calcify2D. Calcify2D offers physicians a computer-assisted procedure to simultaneously score vascular calcifications at the abdominal aorta and lumbar vertebral fractures (according to Quantitative Vertebral Morphometry principles) based on a latero-lateral thoracolumbar spine radiography. Secondary aims are the validation of the scores obtained from latero-lateral thoracolumbar spine radiography with more invasive and/or costly gold-standard imaging modalities (Computed Tomography for VC, Magnetic Resonance for VF) that may have been acquired near-simultaneously to radiographs on the patients enrolled for the study.

STUDY DESIGN Not-for-profit monocentric observational study to be conducted on the diagnostic images of the thoracolumbar spine already collected at Istituto Ortopedico Rizzoli (IOR) within a previous interventional study.

Scoring of VC and VF will be performed by four clinicians from four relevant specialties, chosen among those who may often see VC and VF and are already familiar with the traditional scoring systems for both VC and VF (one radiologist and one spine orthopaedics from IOR, one nephrologist from the National Research Council and one internist from University of Padua).

Each clinician will assess all radiographs to score VC and QVM, both via computer assisted procedures and via traditional visual inspection. To avoid bias, an interval of at least one week will be left between the computer assisted and visual scoring. To define intra-observer variability (i.e. repeatability), the whole dataset will be re-assessed three times.


Eligibility Criteria:
Inclusion Criteria:

* Patients included in a previous interventional study (VTP vs KYPHO) of the sponsor.
* Availability of diagnostic images (Dorso-lumbar radiographies taken in L-L projection).
* Rx images will be screened for the presence of VC, retaining only those showing VC.
* Informed consent obtained prior to any study analysis-evaluation.

Exclusion Criteria:

* Images showing severe artefacts (usually due to presence of metallic devices) that alter the grayscale range and hinder correct identification of VC and vertebral fractures
Pilot Study on BP1.4979 Effect on Binge Eating Disorders

This pilot study is to assess the efficacy and safety of BP1.4979 15 mg BID in female patients with moderate to severe binge eating disorder (BED), as defined according to DSM-5 guidelines.

First clinical study to assess the effect of the BP1.4979 on BED in female patients over an 8 week-tretament period.

Eligibility Criteria:
Inclusion Criteria:

* Patient must voluntarily express a willingness to participate in this study, sign and date an informed consent prior to beginning any protocol required procedures.
* Female aged between 18 and 65 years, inclusive.
* Diagnosis of BED according to DSM-5 criteria
* BMI \< 50 kg/m2.

Exclusion Criteria:

* Current diagnosis of bulimia nervosa or anorexia nervosa.
* History of bariatric surgery.
* Patient who is pregnant, lactating, or of childbearing potential who is not using adequate contraceptive measures. The following are considered adequate methods of birth control: 1. intrauterine device (IUD); 2. barrier protection; 3. contraceptive implantation system; 4. oral contraceptive pills; 5. surgically sterile patient; and 6. abstinence. All participants should have a negative pregnancy test prior to randomization
* Ongoing alcohol or tobacco addiction treatment (except Nicotine Replacement Therapy \[NRT\] with at least one-month stable dose prior to screening visit).
Screening Protocol to Evaluate Acid Alpha-Glucosidase (GAA) Activity and GAA Gene Mutations in Patients With Late Onset Pompe Disease

Pompe disease (also known as glycogen storage disease type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The primary objective of this study is to identify potential candidates for future clinical studies in Pompe disease.


Eligibility Criteria:
Inclusion Criteria:

* Must provide written informed consent prior to any study-related procedures being performed
* Clinical presentation consistent with late-onset Pompe disease, or a current clinical diagnosis of late-onset Pompe disease
* Must be greater than or equal to 8 years of age
* Must be able to ambulate (use of assistive devices, such as a walker, cane or crutches, is permitted)

Exclusion Criteria:

* Requires the use of invasive ventilatory support
* Requires the use of noninvasive ventilatory support while awake and in an upright position
* Use of any investigational product within 30 days prior to study enrollment
* Unwillingness to comply with protocol requirements
* Has clinically significant organic disease, unstable medical condition, serious or intercurrent illness
* Is pregnant or lactating
* Has participated in the Prospective Observational Study in Patients with Late-Onset Pompe Disease (AGLU02303, "LOPOS")