cyrilzakka/clinical-trials huggingface dataset:
Intent Recognition for Prosthesis Control

This work will focus on new algorithms for powered prostheses and testing these in human subject tests. Individuals with above knee amputation will walk with a robotic prosthesis and ambulate over terrain that simulates community ambulation. The investigators will compare the performance of the advanced algorithm with the robotic system that does not use an advanced algorithm.

The focus of this work is a proposed novel AI system to self-adapt an intent recognition system in powered prostheses to aid deployment of intent recognition systems that personalize to individual patient gait. The investigators hypothesize that the prosthesis using our self-adaptive intent recognition system will improve walking speed. Independent community ambulation is known to be more challenging for individuals with TFA, and so the investigators will measure self-selected walking speed (SSWS) which is a correlate with overall health and is a predictor of functional dependence, mobility disability and falls; furthermore, slow SSWS are correlated to lower quality of life (QOL), decreased participation and symptoms of depression. Self-adapting intent recognition has great potential to restore gait in community settings and improve embodiment, which has been associated with improved QOL and increased device usage in patients who use advanced upper limb prostheses. In this experiment, patients with TFA will be fit with our robotic knee/ankle prosthesis and proceed to walk over a treadmill and overground at varying speeds, while the investigators capture 3D biomechanics in both the self-adaptive and static user-independent system (control condition). The investigators expect the self-adaptive system to learn the best prediction of the patient's unique gait, leading to advantages in functional and patient reported outcomes over the control and baseline conditions.

Eligibility Criteria:
Inclusion Criteria:

* A unilateral amputation of the lower limb
* Aged between 18 to 75 years, inclusive
* K3 or K4 level ambulators who can perform all locomotor tasks of interest (based on assessment of the physiatrist and/or prosthetist)
* If a prosthesis is used, the participant must use a prosthetic knee and foot in their clinically prescribed prosthesis.

Exclusion Criteria:

* Individuals with history of neurological injury, gait pathology, or cardiovascular condition that would limit ability to ambulate for multiple hours
* Individuals who are currently pregnant (based on patient self-report) due to slight risk of falling during experiments
Basiliximab vs Low-dose Thymoglobulin Induction Therapy in Low Risk Kidney Transplant Patients

Demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has similar efficacy (delayed graft function, slow graft function, biopsy proven acute rejection episodes, infections, hospitalizations, adverse events, graft loss and death) than Basiliximab induction

Introduction: The TAILOR study in living donor kidney transplantation demonstrated a 98% one year patient and graft survival and 91% and 83% at 5 years with rejection-free patients in 93%. The cumulative dose of r ATG (thymoglobulin) was 5.29 mg / kg with 3% adverse effects and almost 50% steroid free at 12 months. Others have explored the benefit of low doses of r ATG (thymoglobulin) (3-5 mg / kg) against Basiliximab in low-risk population and demonstrated in living donor recipients with 8 year follow-up similar survival rates with a lower BPAR rate in rATG (thymoglobulin) (p \<0.05) and better serum creatinine in 3 and 5 years. The aim of the study was to demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has similar efficacy (delayed graft function, slow graft function, biopsy proven acute rejection episodes, infections, hospitalizations, adverse events, graft loss and death) than Basiliximab induction.

Material and methods: Prospective randomized study of patients undergoing renal transplantation who wish to participate. 100 patients who meet the inclusion and exclusion criteria at the time of transplantation will be randomized

Experimental and reference therapy:

Group A: Induction with Basiliximab 20 mg IV day 0 and day 4 Group B: rATG (Thymoglobulin) 1 mg / kg body weight per day for days 0, 1 and 2 up to a total dose of 3 mg / kg day. According to protocol administration, if there are conditions to delay administration (WBC\<2000 / mm3 and / or platelets \<75,000 / mm3) (17), administration may be postponed until day 7 posttransplant Posttransplant immunosuppression: Tacrolimus, mycophenolate mofetil and steroids

Outcome measures (12 months) delayed graft function slow graft function biopsy proven acute rejection episodes infections hospitalizations adverse events graft loss death

Eligibility Criteria:
Inclusion Criteria:

* Male or female graft recipients older than 18 years of age.
* Informed consent to participate in the study.
* First living donor kidney transplant recipient.
* Negative pregnancy test if female participant

Exclusion Criteria:

* Second or more kidney transplant.
* Multiple organ transplant recipients.
* ABO incompatibility or positive cross-over test prior to transplantation.
* Antibody Reactive Panel (PRA) \> 30%.
* Positive specific donor antibodies (DSA).
* Human immunodeficiency virus (HIV) positive patients.
* HBsAg or HCV positive.
* Severe lung disorders.
* Severe allergies receiving treatment that prevent patient's rRTAG administration.
* Leukocyte count below 2000 / mm3.
* Platelet count below 75,000 / mm3.
* History of malignant disease of any organ system (except skin basal cell carcinoma) within the last 5 years, regardless of local recurrence or metastasis.
PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

This study will determine the level of association between the quantitative estimates of brain uptake of \[18F\]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples previously obtained during shunt placement in patients who have normal pressure hydrocephalus (NPH).


Eligibility Criteria:
Inclusion Criteria:

* The subject is 50 years old or older.
* The subject has had a frontal lobe cortical biopsy adequate for the detection and quantitation of amyloid.
* Informed consent has been signed and dated by the subject/and/or subjects' legally acceptable representative, if applicable, in accordance with local regulations.

Exclusion Criteria:

* The subject has a contraindication for MRI or PET.
* The subject has a known or suspected hypersensitivity/allergy to \[18F\]flutemetamol.
* The subject has participated in any clinical study using an investigational agent within 30 days of dosing.
Difluprednate vs. a Prednisolone Acetate - Phenylephrine on Post-operative Inflammation Following Cataract Surgery.

This controlled, randomized, double blind, multicenter study will be carried out to demonstrate that the topical ophthalmic nanoemulsion of difluprednate 0.05% (Tolf®, Poen Laboratories), has a high anti-inflammatory efficacy, which would allow it to be administered after cataract surgery 1 drop, twice a day , starting the day before surgery and continuing for 14 days and 1 drop, once a day for the following 2 weeks, achieving an adequate anti-inflammatory activity, with the benefit of reducing the toxicity on the ocular surface, improving the dosage and adherence to treatment.

The follow-up time will be 28 days and the outcome measures will be evaluated in a baseline (time 0), on day 1, on day 4 and on day 28 after surgery. The active control will be prednisolone acetate 1% + phenylephrine hydrochloride 0.12% topical ophthalmic suspension (Prednefrin® Forte, Allergan Argentina) given 1 drop, 4 times a days and 1 drop, twice a day for the next 2 weeks. Corneal thickness, central macula thickness, endothelial cell count, intraocular pressure, visual acuity, anterior chamber clearance and lacrimal film recovery will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes between 45 and 65 years old (women who are not fertile) who undergo cataract surgery N2 and N3, defined according to BCN10, Decimal classification of cataracts.
* That the surgical technique is ultrasonic phacoemulsification.
* Patients who have an initial corneal thickness between 500 and 570 µm inclusive.
* Patients with initial intraocular pressure between 12 and 18 mm Hg inclusive.
* Patients with an endothelial cell count greater than 1000 cells / mm2

Exclusion Criteria:

* Patients who use eye medication, except eye lubricant.
* Patients who before surgery have not been able to dilate their pupil more than 5 mm
* Patients who have been treated with corticosteroids or systemic anti-inflammatory drugs for 2 weeks prior to enrollment
* Patients who have received periocular corticosteroid injections in the study eye within the previous 4 weeks or used depot corticosteroids within 2 months prior to enrollment
* Patients who have received a topical ocular corticosteroid or non-steroidal anti-inflammatory drug (NSAID) within 24 hours prior to enrollment
* History of glaucoma or ocular hypertension in the study eye, history or presence of endogenous uveitis, or corneal abrasion or ulceration
* Patients with a diagnosis or suspicion of keratoconjunctival disease caused by viruses, bacteria, or fungi
* Patients which presents an allergy to the drug to be tested or to any similar drug such as other corticosteroids
* History of increased intraocular pressure due to the use of corticosteroids
* Patients with pathological macular features
* Diabetics
* Breastfeeding women
* Patients with rheumatoid arthritis.
* Patients treated with Amiodarone
Vascular Subphenotypes of Lung Disease in HIV & COPD

This study is looking for high blood pressure in the lungs (Pulmonary artery hypertension PAH) in HIV and COPD patients.

The goal of the project is to identify and characterize populations at risk for developing pulmonary arterial hypertension (PAH). The project will establish a PAH subphenotype core cohort (CORE) to evaluate mechanistic pathways and test novel therapeutic agents. This core cohort serves as a resource for the Translational Program Project grant, Vascular Subphenotypes of Lung Disease (Mark Gladwin, PI). In order to construct the CORE, we have chosen to recruit COPD and HIV patients, two populations with advanced lung and systemic diseases that are enriched for PAH. We have selected these as prototypic conditions because: A) both COPD patients and HIV-infected patients develop PAH at a rate significantly greater than the general population, B) morbidity and mortality are greatly increased in dually-affected persons, C) mechanisms responsible for development of the PAH "subphenotype" are not well-understood, D) clinical and genetic characteristics of the subgroup with PAH are not known, and E) effects of PAH therapies in subphenotypes are incompletely studied. There is also some overlap between COPD and HIV, with HIV-infected patients having accelerated COPD even with effective antiretroviral therapy. Participants with COPD, HIV, or HIV-uninfected controls will be recruited to the study based on entry criteria of elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) and/or an abnormal echocardiogram. These subjects will then undergo a 6-minute walk test, blood collection, questionnaire, medical record review, and echocardiography (if not previously performed). Selected subjects will then be recruited to undergo right heart catheterization. The goals of the study are to establish a pulmonary hypertension cohort for translational investigations, to determine the utility of NT-proBNP as a biomarker of PAH, to determine clinical characteristics and relationship of lung function to PAH in COPD and HIV, and to establish a biorepository for mechanistic studies of PAH phenotypes.

Eligibility Criteria:
Inclusion Criteria:

* Male/Female 18-80 years of age.
* Subject has been previously enrolled in PACT/MAC/ECRC study.
* Must have recent ProBNP test \>120pg/ml or abnormal echocardiogram (right ventricular systolic pressure \>or=40mmHg) without evidence of left sided heart failure.

Exclusion Criteria:

* Previous diagnosis of congenital heart failure.
* If evidence of Left ventricular systolic or diastolic dysfunction, echo will be reviewed by the PI on a case by case basis.
* Creatine clearance \<60ml/min per 1.73 m2.
* Undiagnosed chest pain or myocardial infarction, stroke or cardiovascular event within 3 months.
* Pregnancy.
* Subjects receiving chronic anticoagulant.
* Inability to complete the 6 minute walk test.
CORset Versus OstéoSynthese in Adult Pyogenic Spondylodiscitis

Pyogenic spondylitis in adults is usually treated by antibiotics according to bacteria evidenced in a diagnostic intervertebral disc puncture. Brace treatment is associated in patients presenting back pain and a risk for vertebral body collapse due to infection with subsequent kyphotic deformity of the thoracolumbar spine. Percutaneous minimally invasive posterior spinal instrumentation has evolved over the last decade and indications in infections arouse over the last years. This procedure is interesting as it is performed through small skin incisions only. It avoids paravertebral muscle dissection and thus limits intraoperative bleeding and access morbidity. Recent retrospective data suggests that this internal fixation represents a theoretical advantage over brace treatment by lowering back pain and increasing patient's quality of life in the short run, up to 3 months, but no randomized study was published. The patient's autonomy, including walking ability and daily activities, might improve more rapidly after a percutaneous procedure. Additionally, the sagittal alignment of the thoracolumbar spine could be better maintained by internal fixation, which might prevent progression into kyphosis and improve long-term outcome. The hypothesis is the superiority of percutaneous minimally invasive instrumentation on brace treatment in term of quality of life, back pain and quality of osseous healing.

Safety and efficacy of percutaneous for the indication of pyogenic spondylitis has been demonstrated retrospectively on small cohort studies, which is in line with our clinical experience. Although this therapeutic concept seems applicable to patients with spondylitis, the theoretical clinical benefit of minimally invasive surgery remains hypothetic and unclear compared to brace treatment, which might still be regarded as the gold standard.

Eligibility Criteria:
Inclusion criteria:

* adult patients presenting acute pyogenic spondylitis of the thoracolumbar spine
* back pain at a minimum of 4 out of 10 on VAS
* Diagnostic MRI and disc puncture + microbiological analysis required for antibiotic treatment and/or blood culture
* Vertebral body involvement (osteolysis) \< 50% of VB height documented on CT

Exclusion criteria:

* postoperative pyogenic spondylitis or infection after spinal instrumentation spinal tuberculosis and mycosis
* contra-indications for surgery or general anaesthesia
* general septic conditions acute endocarditis documented by sonography
* patients presenting another major abcess or an epidural abscess
* Absence of vertebral body involvement (osteolysis) on CT or minor VB involvement less than 10% of VB height (surgery not indicated)
* Major destruction of vertebral body (\>50%) on CT (surgery mandatory) Patients with concomitant bacterial endocarditis
Prednisolone Treatment in Acute Interstitial Nephritis

A Prospective randomized trial with a primary objective to investigate the effect ofprdenisolone treatment in acute interstitial nephritis


Eligibility Criteria:
Inclusion Criteria:

* Biopsy verified AIN
* Clinical suspicion of AIN
* Age \> 18 years
* One of following criteria:

  * Plasma creatinine \> 120 µmol/L or
  * Plasma creatinine increase \> 30 µmol/L or increase \> 50 % of baseline plasma creatinine
* Fertile women are included

Exclusion Criteria:

* No ability to give informed consent
* Immunosuppressive treatment (including prednisolone) within 3 months before biopsy
* Autoimmune disease
* Prednisolone intolerance
* Pregnancy or lactation
* Active cancer (except basal cell carcinoma)
* Short life expectancy (\< 6 months)
* CKD stage IV-V
* AIN secondary to or accompanied by glomerulonephritis, sarcoidosis or inherited interstitial renal disease
* Previous participation Withdrawal criteria
* Development of exclusion criterion
* Withdrawal of consent
Prevention of Cerebral Infarction in Sickle Cell Anemia - Comprehensive Sickle Cell Center

To conduct a prospective study aimed at the early detection and treatment of cerebral vascular disease prior to irreversible brain injury in young children with sickle cell anemia (SCA).

BACKGROUND:

Cerebral infarction is a major contributor to childhood morbidity and mortality in sickle cell anemia (SCA)

DESIGN NARRATIVE:

The investigators tested the hypotheses that young children with SCA experienced a variable period of asymptomatic progressive central nervous system (CNS) vasculopathy prior to cerebral infarction; that pre-infarct CNS vasculopathy could be identified by non-invasive imaging techniques:MRI, magnetic resonance angiography (MRA), and transcranial Doppler (TCD); and that therapeutic intervention at this stage of the disease could significantly reduce the subsequent occurrence of cerebral infarction. MRI, MRA, TCD, and standardized neurologic and psychometric examinations were performed yearly in a cohort of homozygous Hb SS children enrolled at 2-4 years of age. Subjects without MRI evidence of cerebral infarction who had significant cerebral vasculopathy (cerebral arterial stenosis on MRA and/or elevated blood flow velocity on TCD) were randomized to receive either no therapy or chronic transfusion therapy, in order to determine the risk of subsequent cerebral infarction in untreated subjects with these abnormalities, and the extent to which transfusion therapy could significantly reduce the risk. Subjects with evidence of prior cerebral infarction on MRI, whether symptomatic or asymptomatic, were randomized to receive either chronic transfusion therapy alone ('standard therapy') or chronic transfusion therapy plus ticlopidine, in order to determine whether ticlopidine could significantly increase the efficacy of standard therapy in preventing recurrent cerebral infarction in SCA. Subjects with prior cerebral infarction were also offered the option of bone marrow transplantation if an HLA-identical non-SS sibling donor was available.

Eligibility Criteria:
No eligibility criteria
Hypercoagulation Screening in Cancer

There is a complex, mutual relationship between cancer and thrombosis. Indeed, the tumor has the capacity to activate the hemostatic system and this leads to an increased thrombotic risk in cancer patients. Even in the absence of clinical manifestations, cancer patients are commonly characterized by hemostatic abnormalities, recognized only by laboratory testing, which define the 'hypercoagulable state'. Of interest, hypercoagulation has been repeatedly reported to be associated with tumor progression and poor prognosis in various carcinomas. On the other hand, thrombotic event can represent the first signal of the presence of an occult tumor. These findings suggest that the coagulant pathway might play a role in the preclinical phase of cancer. The investigators hypothesize that a persistent, subclinical activation of the hemostatic system in an otherwise healthy subject, may predispose not only to thrombosis, but also to tumor formation and spreading. A major problem in primary cancer prevention is the lack of effective predictive markers of the disease. The HYPERCAN is an ongoing prospective Italian multicenter study organized around two tightly-interconnected research programs aiming to: 1_the assessment of thrombotic markers as a tool for cancer risk prediction in two large populations of healthy subjects, i.e. a group of healthy blood donors of Bergamo and Milano Provinces and a subgroup of Moli-sani subjects of the Molise region; and 2_ the evaluation whether thrombotic markers and/or the occurrence of overt thrombosis (or disseminated intravascular coagulation) may be prognostic of cancer disease outcomes (i.e. overall survival, progression free survival in metastatic cancer, disease free survival in limited disease) in cancer patients with different types of solid tumors (i.e. breast, lung and gastrointestinal cancers).

Therefore, the assessment of cancer risk occurrence in healthy individuals might be useful for anticipation of cancer diagnosis. In addition, the results of this study might help to evaluate whether thrombotic markers may be prognostic of cancer outcomes independently of the disease extension.


Eligibility Criteria:
Blood donors_

Inclusion Criteria:

* good health
* signed informed consent.

Exclusion Criteria: (considering 10-15 days from blood sampling)

* inflammations/infections/fever;
* recent vaccinations;
* recent surgery;
* anticoagulant therapy.

Cancer patients_

Inclusion Criteria:

* with life expectation higher than 3 months;
* patients with breast, lung or gastrointestinal tumors candidated for chemotherapy regimen;
* ECOG PS 0-2;
* adeguate bone marrow and renal function;
* signed informed consent.

Exclusion Criteria:

* acute medical illness;
* terminal conditions or life expectancy less than 3 months;
* under low molecular weight heparin at therapeutic dosage.
Dorsomedial Prefrontal Cortex and the Antidepressant Efficacy of Theta Burst Stimulation in Depressed Patients

This study evaluates an association between different dosage and the antidepressant efficacy of theta burst stimulation in patients with treatment-resistant depression. In a double-blind design, All patients are randomized to three groups, i.e. standardized dosage intermittent theta-burst stimulation treatment, high dosage intermittent theta-burst stimulation treatment or sham treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 21 to 70 years of age.
* Diagnosed with the recurrent Major depressive disorder (MDD) and currently having a Major Depressive Episode (MDE)
* Participants failed to respond to at least one adequate antidepressant treatment in their current episode
* Participants have a Clinical Global Impression - Severity score of at least 4 and a total score of at least 18 on the Hamilton Depression Rating Scale (HDRS-17) at both screening and baseline visits ( Day -14 and Day 0)
* Participants must discontinue their antidepressant medications at least for one week ( at least two weeks if Fluoxetine) prior to the TMS intervention and keep antidepressant-free during the study duration.
* Participants also failed to respond to one complete left-sided DLPFC 10Hz rTMS/piTBS treatment course.

Exclusion Criteria:

* a lifetime psychiatric history of bipolar disorder, schizophrenia, psychotic disorders, or organic mental disorder including substance abuse and dependence (based on DSM-IV criteria)
* Participants with a lifetime medical history of major systemic illness and clinically significantly abnormal screening examination that might affect safety, study participation, or confound interpretation of study results.
* Participants with a lifetime medical history of neurological disorder records (e.g., stroke, seizure, traumatic brain injury, post brain surgery), brain implants (neurostimulators), cardiac pacemakers
* Women with breastfeeding or pregnancy
* Participants with a current strong suicidal risk (i.e., a score of 4 on item 3 of the HDRS-17)