cyrilzakka/clinical-trials huggingface dataset:
Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions

To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart), of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in patients with exudative age-related macular degeneration and evidence of recent onset, subfoveal and/or juxtafoveal choroidal neovascularization.


Eligibility Criteria:
Inclusion Criteria:

* Clinical and angiographic evidence of juxtafoveal or subfoveal choroidal neovascularization secondary to AMD with a total lesion size of less than 2 MPS disc areas
* Best-corrected visual acuity in the study eye greater than 54 letters (ETDRS)
* Women must be using 2 forms of effective contraception
* Adequate hematological, renal and liver functions

Exclusion Criteria:

* Any atrophy or fibrosis; any retinal hemorrhage measuring more than 1 disc area
* Any extrafoveal choroidal neovascularization
* Any intraocular surgery or thermal laser to the study eye within 3 months of enrollment
* Previous or concomitant therapy for AMD including PDT with verteporfin (Visudyne) or subfoveal/non-foveal thermal laser therapy, transpupillary thermotherapy, external beam radiation, submacular surgery.
* Presence of other causes of choroidal neovascularization, including pathological myopia, the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis
Oxygen Toxicity of HBOT in Chronic Brain Injury

Hypothesis: That HBOT can be toxic in the low-pressure range.

The study is a retrospective review of the author's experience treating chronic brain injury with HBOT, supplemented by cases communicated to the author, who developed untoward effects during or after their HBOT. The object of the study was to affirm or refute the author's general impression that there was an optimal dose of HBOT in chronic brain injury which was lower than the traditional dose applied in chronic non-central nervous system wounding. Furthermore, when this lower dosage range was exceeded and approached the traditional doses for non-CNS wounding oxygen toxicity would result. To address these impressions the study seeks to review the author's medical records and other patient/doctor communications to the author where side effects of HBOT occurred in the treatment of chronic brain injury and abstract signs, symptoms, and the dose of HBOT employed.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral disorder of greater than one year's duration

Exclusion Criteria:

* None
Preliminary Study Examining Heart Failure Patients Responses to Depression Education

Purpose of the Study: The significant impact of depression on the poor prognosis and functional restrain, recognition and successful treatment of depression in patients with Chronic Heart Failure (CHF) may result in improvement of overall outcome of those patients. However, depression comorbid with CHF has been overlooked in the real practice. Therefore, the investigators are proposing a study to 1) assess the prognostic impact of depression in patients with stable CHF who have been managed as outpatients, and 2) assess whether provision of depression education to CHF patients will improve the care of depression.

Patients with chronic heart failure are enrolled into this study with a half of them are randomly assigned to receive a packet of depression education materials and then other half not. Participants and investigators both are blinded to the assignment. All the participants are provided a toll free phone number to contact the research team as needed. Depressive symptoms and patients knowledge of depression are assessed at baseline prior to randomization and at 1-month and 6-month following the enrollment.

Responses of the study participants, such as change of depressive symptoms, and requests for psychiatric help are examined between two groups.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria

* LVEF ≤ 35%.
* NYHA class II, III, or IV heart failure for the previous three months despite a minimum of 6 weeks of treatment.
* Must be on optimal heart failure therapy according to AHA/ACC and HFSA heart failure guidelines, including treatment with ACEI and beta-blocker therapy, or have documented rationale for variation, including intolerance, contraindication, patient preference, or personal physician's judgment.

Exclusion Criteria:

* Age less than 18.
* Currently pregnant or intending to become pregnant in the next year.
* Cardiovascular procedure or hospitalization for any reason planned in the next 6 months.
* Expectation of receiving a cardiac transplant in the next six months.
* Unable to provide the study consent.
* Participation another clinical trial(s) that may interfere with follow-up or data collection for this study, or that may affect cardiovascular mortality.
CogEcig: Cognitive Functioning and Electronic Cigarette

The aim of the present study is to compare cognitive scores (attention, executive function and working memory) of different e-Cigarette strength with usual cigarettes.

The study is randomised cross-over trial designed to compare: 1) Cognitive performances levels for four different e-Cigarette strength. Participants will be requested to abstain from smoking and alcohol from 20:00 on the night before each study day and from food and caffeine for at least 1 h before the session. On arrival at the study centre, carbon monoxide (CO) will be measured in participants' expired breath. If CO will be \>15 parts per million (ppm), the assigned study treatment will be allocated; however, if CO was \>15 ppm or they will report smoking in the previous 12 h, participants will be rescheduled wherever possible to a subsequent session.

On the first study day, participants will be randomised to use one of five ordered conditions: Electronic Nicotine Delivery Device (ENDD) (fourth generation) containing nicotine 2,4%; Electronic Nicotine Delivery Device (ENDD (second generation) containing nicotine 7,4 mg; Electronic Nicotine Delivery Device (ENDD containing nicotine 9 mg; Electronic Nicotine Delivery Device (ENDD nicotine free; their usual cigarette. Additionally participants will be trained to use an electronic cigarette. The following tests will be completed at the each visits: Continuous Performance Test - AX version (CPT-AX), Wisconsin card sorting test( WCST), Working memory test (N-BACK).

Eligibility Criteria:
Inclusion Criteria:

* 20 regular smokers (smoking ≥ 15 factory-made cigarettes per day for at least the past 10 years and not currently attempting to quit smoking or wishing to do so in the next 30 days, CO \> 10 parts per million ) will be recruited from the local Hospital staff in Catania, Italy.

Exclusion Criteria:

* people who reported recent myocardial infarction, angina pectoris or other serious medical conditions (diabetes mellitus, severe allergies, poorly controlled asthma or other airways disease, poorly controlled psychiatric disorders or current chemical dependence other than nicotine) and
* pregnancy,
* breastfeeding,
* blood pressure \> 180 mm Hg systolic and/or 100 mm Hg diastolic,
* weight \< 45 or \> 120 kg, or
* current use of any other smoking cessation medications
Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers

This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

Cognitively Healthy Volunteers

* Mini-mental state examination (MMSE) ≥ 28
* No history of cognitive decline or parkinsonian motor disorder

CBD and PSP subjects

* Able to walk 10 steps with minimal assistance
* MMSE ≥ 14 and ≤ 30
* Subject has a reliable study partner who agrees to accompany subject to visits and spends at least 5 hours per week with the subject

PSP subjects only

* Meet National Institute of Neurological Disorders and Stroke - Society for Progressive Supranuclear Palsy (NINDS-SPSP) probable or possible PSP criteria as modified for the Neuroprotection and Natural History Parkinson Plus Syndromes (NNIPPS) clinical trial

CBD subjects only

* Meets 2013 consensus criteria for possible or probable corticobasal degeneration, corticobasal syndrome (CBS) subtype

Exclusion Criteria:

All subjects

* Have evidence of structural abnormalities such as vascular disease, large strokes or severe white matter disease or other mass lesion on screening MRI
* Claustrophobia
* Current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (e.g. corrected QT interval \>450 msec)
* Have a history of risk factors for Torsades de Pointes (e.g. heart failure, hypokalemia, family history of long QT syndrome)
* Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
* Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
* Have received or participated in a trial with investigational medications in the past 30 days
* Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
* Have a history of neuroleptic use for a prolonged period of time or within the past 6 months

PSP and CBD subjects

* Have evidence of amyloid deposition
* Meet National Institute on Aging-Alzheimer's Association criteria for probable Alzheimer's Disease
* Have any other neurological condition other than CBS or PSP that could account for cognitive or motor deficits
* Serum or plasma progranulin level less than one standard deviation below the normal subject mean for the laboratory performing the assay
* Have a high-risk family history suggestive of tar DNA binding protein (TDP)-43 pathology or known mutations
A Study to Evaluate a Leukapheresis Treatment in Patients With Ulcerative Colitis

The purpose of this study is to determine whether a treatment of a novel leukapheresis column is safe and effective in patients with moderate to severe ulcerative colitis.

Ulcerative colitis (UC) is a chronic and relapsing disease and is characterized by superficial inflammation in the colonic epithelium. The inflammation is maintained by continuous supply of inflammatory cells from the circulating blood to the intestinal mucosa.

Existing therapy e.g. corticosteroids and immunosuppressants are inadequate with an overall long-term remission rate of only 50-60%. Those treatments are also associated with severe side effects why there is a need of new therapies.

The aim of this study is to investigate a novel leukapheresis treatment with the potential to reduce the number of inflammatory cells homing to the gut mucosa. By drawing blood from the patient and pass it through the investigational column the inflammatory cells are removed. The blood, depleted of the inflammatory cells, is returned to the patient.

The treatment thus enable down-regulation of the inflammation and consequently the inflammation can heal. The treatment is called Tailored leukapheresis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of active, moderate-to-severe, Ulcerative Colitis.

Exclusion criteria;

* Local intestinal treatments with suppositories, enemas or clysmas during the last 4 weeks
* Current daily smoking habits
* Other severe diseases as detailed in the protocol
* History of hypersensitivity to heparin
Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia

The primary objectives are a) to establish the maximum tolerated dose (MTD) of gemtuzumab ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients with relapsed or refractory AML, as well as younger de novo AML patients are eligible for the study
* Relapsed, refractory, and de novo AML patients are allowed in Phase I of this study
* Phase II will only allow enrollment of younger de novo AML

Exclusion Criteria:

* AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of greater than 2 months duration
* De novo patients with M3 AML
* AML secondary to exposure to chemotherapy or radiation
A Study Evaluating the Efficacy of Administered Maintenance Treatments in Bipolar Disorder I and II.

The primary objective of the study is to evaluate the efficacy of administered maintenance treatments in bipolar disorder I and II, defined as the percentage of patients who experience a relapse episode during the first 9 months after a mood event (manic or depressive).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who experienced the last acute mood episode during the last 2 months and are in euthymic state (YMRS score ≤12 and HAM-D score ≤12) for at least two weeks
* Diagnosis of bipolar disorder I or II (as per DSM-IV), with or without rapid cycling
* Subjects who have been treated with at least one atypical antipsychotic for the management of an acute mood event (manic or depressive) as monotherapy or in combination with other medication
* Provision of informed consent prior to study participation

Exclusion Criteria:

* Subjects fulfilling criteria for diagnosis of any other psychiatric condition (except from bipolar disorder I or II), as per DSM-IV Axis Ι, concomitant organic mental disorder or mental retardation
* Subjects who have received treatment with a depot
* Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria
* Inability of subjects to comply with the study protocol.
Under the Nose Face Mask to Prevent Facial Pressure Ulcers During NIV for Acute Hypercapnic Respiratory Failure (AHRF)

Noninvasive ventilation (NIV) is essential to treat acute hypercapnic respiratory failure. However, facial pressure ulcers appearing during facemask-delivered noninvasive ventilation are a source of NIV failure by interface intolerance.

A Philips facemask (model : AF541 SE Oro-Nasal mask) has the particularity to display two options for its positioning : a usually used "over-the-nose" positioning or an "under-the-nose" positioning that is supposed to reduce the incidence of facial pressure ulcers while keeping in the same time the qualities of a standard facemask.

The goal of this controlled randomized trial is to test the hypothesis that the "under-the-nose" positioning actually reduces the incidence of facial pressure ulcers, compared to the usually used "over-the-nose" positioning.

Results of this trial should lead to the proposition of a new interface strategy to prevent facial pressure ulcers and therefore to improve the tolerance of NIV via the use of facemasks displaying an "under-the-nose" positioning.


Eligibility Criteria:
Inclusion Criteria:

* Acute hypercapnic respiratory failure
* Initiation of NIV
* Estimated cumulative time of NIV upper than 12 hours for the first 48 hours of hospitalization

Exclusion Criteria:

* Contraindication for NIV (respiratory arrest, impossibility to fit the mask)
* Intubated patient
* Patient with a tracheostomy
* Post-extubation respiratory failure
* Patient exhibiting facial ulcers or skin lesions located at the insertion points of the mask before its hospitalization
* Person declining NIV
* Pregnancy
* Dying person
Comparing Optical Coherence Tomography (OCT) and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care

To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on visual acuity and OCT measurements.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age.

  * Expectation of 20/25 best corrected visual acuity (BCVA) post-operatively.
  * Patients should be in good general health and devoid of recognized risk factors for CME.
  * Patients with systemic diseases are eligible only if there were no ocular manifestations of the disease (specifically diabetics without retinopathy)
  * Patients must be likely to provide informed consent, take study medications as directed, and complete all study visits
  * Only one eye of each treated patient may be included in the study

Exclusion Criteria:

* Any known contraindications to any study medication or their component
* Presence of uncontrolled systemic disease
* Required use of other ocular medications during the study

  o Artificial tears may be used
* Diabetics with any clinically evident or history of retinopathy
* Individuals with age-related macular changes, epi-retinal membranes, other retino-vascular diseases and/or other macular disorders thought to have a less than 20/25 surgical outcome expectation
* Abnormal pre-operative OCT (if obtainable)
Hepatocellular Carcinoma Growth and Molecular Aggressiveness

Our long-term objective is to develop a new tool based on a (molecular-biology) integrated imaging technology able to characterize and categorize hepatocellular carcinoma (HCC) patients in need of liver transplant (LT). To this end, our study aims at correlating specific imaging traits and fractional growth of individual tumors collected over a restricted time frame (T0 and at week 7 after first tumor detection), with a "molecular signature", obtained by custom microarray, histochemical and cytokine analysis. This should allow us to translate a series of purely morphologic information into a meaningful pathobiologic data sets. Validation of the integrated molecular-imaging tool will be performed prospectively by correlating the imaging-molecular data with HCC outcome in term of survival and disease-free survival after down staging procedures.

Organ allocation in our region is regulated according to MELD score. Patients with hepatocellular carcinoma (HCC) receive an additional score depending on size of the tumor and the time spent in transplant waiting list. However, the advantage given to these patients is uniform and does not take into account the profound biological heterogeneity of individual HCCs. To make the additional score righteous, the investigators need to identify patients with aggressively growing HCC who require salvage transplantation while those with slow-growing HCC do not deserve the additional score.

All cirrhotics with suspect HCC identified at routine US screening will be therefore enrolled in the prospective imaging and bio-molecular study.

They will be subjected to two computed tomography (CT) exams at 7 weeks interval to define fractional tumor growth and imaging traits, baseline US-guided liver biopsy for microarray and histochemical characterization, serum sampling for cytokine assay. Survival, disease-free survival after downstaging and transplant outcome will be recorded and analyzed in relation with imaging and molecular data. The investigators expect to set up an accurate imaging and molecular diagnostic tool able to identify patients with aggressive HCC requiring urgent access to transplant, reliable in predicting survival, standardisable and not too expensive.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients at first US identification of a focal lesion compatible with HCC
* Age \> than 18 years
* No contraindications to performance of CT
* No contraindications to performance of US-guided liver biopsy

Exclusion Criteria:

Patients will be excluded if

* are unable to give informed consent to the study;
* liver tissue obtained at biopsy is insufficient to perform molecular/histochemical study
Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer

A study to measure the safety and effectiveness of S-3304 when given in combination with conventional chemo-radiation therapy in patients with locally advanced non-small cell lung cancer.

A two part study to evaluate the safety and efficacy of S-3304 in combination with standard therapy in patients with locally advanced non-small cell lung cancer. The first part of the study is a Phase I design to evaluate the maximum tolerated dose of S-3304 when given in combination with radiation and paclitaxel/carboplatin chemotherapy that is appropriate for further evaluation. The second part of the study is a randomized Phase II design to evaluate the efficacy of recommended S-3304 dose in combination with chemo-radiation.

Eligibility Criteria:
INCLUSION CRITERIA

* newly diagnosed non-small cell lung cancer of stage IIIA non-resectable or of stage IIIB without pleural effusion
* ECOG performance status 0-1
* adequate organ function
* clinically indicated and able to receive conventional chemoradiation therapy

EXCLUSION CRITERIA

* patients with prior history of cancer, other than basal cell carcinoma after appropriate treatment, or prior systemic chemotherapy treatment
* patients with other serious intercurrent illness including HIV/AIDS, or contraindicated for paclitaxel/carboplatin or thoracic irradiation treatment
Inulin and Acetate Production and Human Substrate Metabolism

Based on our hypothesis that orally administered resistant starch and inulin/beta glucan will be fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects on human substrate and energy metabolism, we aim to address the following primary objective:

To investigate the effects of an acute administration of inulin/beta glucan in combination with resistant starch on fecal and plasma acetate, as well as on fasting and postprandial substrate and energy metabolism in lean normoglycemic men and obese, prediabetic men.


Eligibility Criteria:
Inclusion Criteria:

* lean (BMI ≥ 20kg/m2 and ≤ 24.9kg/m2)
* normoglycemic
* aged 30 - 65 years

OR

* overweight/obese (BMI ≥ 25kg/m2 and ≤ 34.9kg/m2)
* pre-diabetes
* aged between 30 - 65 years.

Exclusion Criteria:

* diabetes mellitus
* gastroenterological diseases or major abdominal surgery (allowed i.e.: - appendectomy, cholecystectomy)
* lactose intolerance and other digestive disorders
* cardiovascular disease, cancer, liver or kidney malfunction (determined -based on ALAT and creatinine levels, respectively)
* disease with a life expectancy shorter than 5 years
* Use of antibiotics 3 months prior inclusion
* Use of probiotics or prebiotics