cyrilzakka/clinical-trials huggingface dataset:
Oxytocin and Resting State fMRI

The goal of the study is to investigate the effects of intranasal oxytocin (OT) or placebo to resting state brain activity in healthy males.

Although several fMRI studies investigated the neural correlates of OT administration, only few have focused on the underlying modulatory effects of OT on baseline brain function. While functional MRI examines the neural activity during a certain task, it might be especially interesting to assess the main effect of OT on the basic activity of the human brain in rest. This resting state activity becomes typically evident in the default mode network (DMN), compromising midline structures such as medial frontal cortex, cingulate and precuneus, as well as specific resting state networks .

In fact, a recent study succeeded in demonstrating a modulatory influence of OT. Recent studies were able to show an increased functional connectivity at rest of amygdala to the medial prefrontal cortex (PFC) in a small sample of 15 subjects.

However, distinct subregions of the amygdala seem to be involved in different OT effects. To goal of the present study is to decipher the modulatory effects of OT to subregions of the amygdala in a larger sample using improved anatomical mapping of the seed regions and relate these alterations to individual traits of healthy volunteers. We expected to add evidence to the increase of amygdala - PFC connectivity under OT as well as detailed anatomical mapping of this networks.

Eligibility Criteria:
Inclusion Criteria:

* Health

Exclusion Criteria:

* Chronic physical or mental illness, regular smoking or alcohol consumption and medication intake
Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma

This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.

This single-arm, open label study had the following sequential phases: Screening, Pretreatment, Treatment and Follow-up. In the Pre-treatment phase, the patient could undergo bridging therapy (optional) and lymphodepleting (LD) chemotherapy. Treatment and Follow-up Phase included tisagenlecleucel infusion, and safety and efficacy follow-up for at least 24 months. For all the patients who received tisagenlecleucel infusion, additional survival follow-up was to be performed to determine survival status every 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A)
* Radiographically measurable disease at screening

Exclusion Criteria:

* Evidence of histologic transformation
* Follicular Lymphoma Grade 3B
* Prior anti-CD19 therapy
* Prior gene therapy
* Prior adoptive T cell therapy
* Prior allogeneic hematopoietic stem cell transplant
* Active CNS involvement by malignancy

Other protocol-defined Inclusion/Exclusion criteria may apply.
Suture-based, Minimally Invasive Technique Used to Correct NSD

Nasal Septal Deviation (NSD) is one of the most common indications for surgery seen by ENT physicians, however, correction requires open surgery which is associated with several weeks of recovery. The purpose of this study is to elucidate whether a suture-based, minimally invasive technique can be used to safely and effectively address NSD.

Nasal obstruction due to structural issues such as nasal septal deviation (NSD) is remarkably common. NSD is caused by warping of the midline cartilage and bone of the septum, which starts between the 2 nostrils, and extends 7 cm posteriorly to the nasopharynx. This crooked or deviated conformation in the nasal septum cartilage and/or bone leads to physical blockade of normal airflow through the nose, often leading to complaints of nasal congestion, sleep disturbance, exercise limitations, and even poor compliance with CPAP mask use for treatment of obstructive sleep apnea (OSA). To correct this structural issue in symptomatic patients, septoplasty surgery under general anesthesia is typically advocated.

As an alternative to standard septoplasty, there are rare reports of simplified suture techniques that may be used to straighten the nasal septal cartilage. However, virtually all published studies to our knowledge have still required 1) some degree of cartilage/bone excision, which can destabilize the nasal support framework, and 2) use of non-locking sutures which can break, provide insufficient support, and be technically challenging given that it requires knot tying within the narrow nasal cavity corridors.

The investigators have demonstrated in benchtop models that similar results to standard septoplasty techniques can may be achieved with the use of a non-retractable suture without the need for cartilage excision. This technique, therefore, could allow for a simple, and knotless, minimally invasive way to improve and/or correct symptomatic NSD.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Patients from all ethnic and geographic backgrounds within the Stanford Sinus Center with symptomatic NSD
* Primary patients with NSD without past septum surgery
* Patients who have failed maximum medical therapy
* Patients whose symptoms, examination and/or imaging findings are sufficiently severe as to warrant septoplasty as determined by the treating surgeon

Exclusion Criteria:

* Age \< 18
* Recent surgery of any kind (\<1 month)
* Inpatients
* Previous nasal septum surgery
Attention Training to Modify Error-related Negativity and Risk for Anxiety in Adolescence

This is a multi-site study to examine error-related brain activity (i.e., the error-related negativity) and anxiety symptoms in 11 to 14 year-olds (N=600) at two time points separated by two years. The study examines the degree to which error-related negativity can predict anxiety prospectively over two years, and whether a computerized game that alters attention to threat can alter error-related negativity and trajectories of anxiety.

Approximately 600 youths between the ages of 11 and 14 and their parents will be assessed. Adolescents will be evaluated at baseline using event-related potentials, self-report, and interview-based measures. The error-related negativity will be evaluated immediately (it takes less than 5 minutes to process and score a single subjects' error-related negativity ), and adolescents with good error-related negativity data (\~90%, based on scorable error-related negativity data) will be randomly assigned to either an 8-week (i.e., 16 session) adaptive attention bias modification (N=180) or control condition (N=180) or a waitlist condition (N=180) group. Each session lasts 20 minutes, and participants will be asked to complete two 20-minute sessions per week. Participants will be assessed immediately at post, using the same measures from the baseline assessment. All participants will complete a 2-year follow-up lab visit using the same measures from the baseline assessment.

Eligibility Criteria:
Inclusion Criteria:

* children and parent must speak English well enough to complete the study assessments

Exclusion Criteria:

* current threat of harm to self or others, bipolar illness, psychosis, thought disorder, pervasive developmental disorder, mental retardation, neurological diseases that impair cognition, or significant head injuries (past 3 months).
Changes in the T-wave Alternans in Patients With Heart Failure Treated Wih Sacubitril-Valsartan

The aim of this study is to know if the Sacubitril-Valsartan treatment improves the T-wave alternans in those patients that begin its treatment, which would indirectly show a lower risk of malignant ventricular arrythmias.

Sacubitril-Valsartan has shown to reduce sudden death in its principal clinical trial, PARADIGM-HF.

A T wave alternans (TWA) is an electrophysiological phenomenon that acts as an independent predictor of sudden death and ventricular arrhythmias in postinfarct myocardial.

TWA is measured by using a special software and electrodes during a treadmill test, that analyse small changes in the microvolt of the T wave consecutive with a complex algorithm in three dimensions. The TWA could be negative (normal), positive (pathological) or indeterminate. If a TWA is pathological it reflects an electric instability in depolarization.

Our hypothesis is that the treatment with Sacubitril-Valsartan in heart failure patients with reduced ejection fraction, could improved the TWA.

Eligibility Criteria:
Inclusion Criteria:

* Adults from 18 to 80 years old.
* Patients with grade II heart failure according to the New York Heart Association (NYHA).
* Left systolic disfunction: left ventricle ejection fraction\<40%
* NT-proBNP \> 600 pg/ml (or \> 100 pg/ml in the case the patients has been hospitalised during the last year.
* Treated with ACE or ARA II+betablocker at stable doses during the prior 4 weeks to the beginning of the study.

Exclusion Criteria:

* Previously treated with Sacubitril-Valsartan.
* Allergy or intolerance to ARA II.
* Systolic blood pressure \< 100 mmHG at inclusion.
* Glomerular Filtration \<35 ml / min / 1.73 m2 of body surface.
* Level of potassium \> 5,4 mEq/l.
* Impossibility to walk on a treadmill.
* Record of recovered sudden death or documented ventricular tachycardia.
* Carrier of an automatic implantable defibrillator.
Study of Accuracy of NGAL, a Renal Injury Biomarker, in Patients With Cirrhosis

The purpose of this study is to test the accuracy of urinary neutrophil-gelatinase associated lipocalin (NGAL) and other biomarkers (plasma renin, norepinephrine) to predict acute kidney injury (AKI) development in patients with cirrhosis and bacterial infection and to predict response to AKI treatment with albumin and albumin with terlipressin in patients with suspected hepatorenal syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis diagnosis by liver biopsy or combination of clinical, laboratorial, endoscopic and imagenological data;
* Presence of ascites and/or hepatic hydrothorax;
* Age over 18 years old;
* Diagnosis of bacterial infection (including spontaneous bacterial peritonitis and others) with or without acute kidney injury (defined as a serum creatinine above 1.5mg/dL at admission) or acute kidney injury without bacterial infection;
* Agreement to participate in the study, registered by informed consent;

Exclusion Criteria:

* Serious comorbidities (functional class IV heart failure, O2 dependent chronic obstructive pulmonary disease, advanced cancer);
* Shock, as defined by American College of Chest Physicians;
* Chronic kidney disease with serum creatinine persistently above 1.5mg/dL in the previous 6 months and/or with sonographic findings of chronic nephropathy;
* Intrinsic nephropathy with hematuria over 50 red cells/high power field and dysmorphic erythrocyte and/or proteinuria over 500mg/24h;
* Use of nephrotoxic drugs in the previous 30 days;
* Dialysis prior to study inclusion;
* Previous solid organ transplantation.
Intervention Facilitates Oral Feeding in Premature Infants

Skin-to-skin combined with breastfeeding shortened the cycle of full-oral feeding in premature infants

This study is conducted at the level 3 NICU of the Children's Hospital of Fudan University, Shanghai, People's Republic of China, a tertiary medical center. Infants admitted to the NICU are all outborn infants.

The study is approved by the Ethics Committee of the Children's Hospital of Fudan University. Signed parental consent is obtained before participants'entry into the study. The RCT is conducted to evaluate the effectiveness of skin-to-skin combined with breastfeeding reduce the transition time from tube feeding to independent oral feeding.

The recruited infants are assigned to intervention group and control group.

Data are presented as means ± sds for continuous variables with normal distribution and percentages (%) for categorical variables. One-way analysis of variance and Fisher exact test is used to compare infants' baseline characteristics among the two groups. All statistical analyses are conducted using SPSS. A p value of less than 0.05 is regarded as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* gestational age ≤30 weeks
* birth weight \< 1500g
* age of admission \<72 hours
* no congenital malformation

Exclusion Criteria:

* OI \> 40
* mother has trouble in communicating
Losartan for Improved Vascular Endothelial Function After Preeclampsia

Women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to blood vessel damage and increased inflammation that occurs during the preeclamptic pregnancy and persists postpartum. The purpose of this investigation is to determine the mechanisms contributing to this lasting blood vessel damage and to test whether taking a medication that blocks angiotensin II receptors (losartan) decrease these negative effects in women who have had preeclampsia. Identification of these mechanisms and treatment strategies may lead to better clinical management,of cardiovascular disease risk in these women.

In this study we use the blood vessels in the skin as a representative vascular bed. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a nickle-sized area of the skin in women who have had preeclampsia. We make these measurements after the subjects take a placebo and after they take losartan (an angiotensin II receptor blocker) to test whether this treatment improves vascular function in these women. As a compliment to these measurements, we also draw blood from the subjects and isolate the inflammatory cells to test how sensitive their inflammatory responses are following the placebo and the losartan treatment.


Eligibility Criteria:
Inclusion Criteria:

Post-partum women,

* 18 years or older,
* who have delivered within 24 months of the study visit
* who have had a preeclamptic pregnancy diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for preeclampsia. \[This information will be self-reported by the subjects.\]
* Using an effective method of birth control and not planning to become pregnant in the next 6 months.

Exclusion Criteria:

* skin diseases,
* current tobacco use,
* diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR \< 60 mL/min/1.73m2,
* statin or other cholesterol-lowering medication,
* current antihypertensive medication,
* history of hypertension prior to pregnancy,
* history of gestational diabetes,
* current pregnancy or breastfeeding,
* body mass index \<18.5 kg/m2,
* allergy to materials used during the experiment.(e.g. latex),
* known allergies to study drugs.
Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Patients at Increased Risk for the Development of Ventilator-associated Pneumonia in the Intensive Care Unit

Ventilator-associated pneumonia (VAP) remains the most frequent healthcare-associated infection (HAI) in the intensive care unit (ICU) and one of the most critical risk factors associated with both significant morbidity as well as mortality. Although VAP treatment relies on early and appropriate antimicrobial therapy, several preventive measures have been described in the literature in order to limit its incidence and clinical impact in the ICU. Among these, preventing biofilm formation on the inner surface of the endotracheal tube appears to hold promise. Yet there is a lack of clinical relevant data documenting a causal relation between biofilm formation and VAP. Designed to overcome this critical limitation, the BIOPAVIR study intends to provide a better structural and microbiological characterization of endotracheal tube biofilm in critically ill patients at increased risk for the development of VAP in ICU during COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

* patient \> 18 years of age with mechanical ventilation for \>2 calendar days

Exclusion Criteria:

* inability to collect or dispatch the endotracheal tube for proper characterization within 24 hours post-extubation
Hydration Based on Thoitaine, Aloe Vera and Calendula, in the Prevention of Hand-Foot Syndrome in Patients Using Capecitabine

Hand-foot syndrome (HFS) is a very common adverse event of many chemotherapeutic agents, especially capecitabine. The HFS can considerably interfere patient quality of life (QoL).

The current treatments for hand-foot symptoms no have demonstrated 100% efficacy. And, the dose reduction and treatment interruption are recommended for treatment of HFS.

It is known that hydration improves the degree of hand-foot syndrome, as it improves moisture retention and maintain hydration, thereby reducing further desquamation and decreasing infection risks. But so far there is no evidence of a cream that improves incidence. Besides that, clinical trials evaluating the use of urea-based moisturizer in patients treated with capecitabine have not shown efficacy in preventing hand-foot syndrome.

The purpose of this study is to evaluate the effectiveness of moisturizer based on Thoitaine, Aloe Vera and Calendula compared to placebo in the prevention of SMP of any degree, in patients using Capecitabine.

The research product, proposed in this study, was developed to meet the specific hydration needs of patients undergoing cancer treatment and is produced from nine main ingredients with natural moisturizing actions based on glycerin, hazelnut extract, shea butter, aloe vera, calendula, chamomile and oat extract and 2 antioxidants (vitamin E and Thoitaine), dermatologically tested and approved. The choice of the product was based, mainly, due to its natural components, whose data from previous studies were extrapolated from radiodermatitis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years of age
* Patients with gastrointestinal tumors or breast cancer who will be treated with capecitabine
* Indication of adjuvant or palliative treatment with capecitabine
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Information of the patient and signature of the informed consent form by the patient or her legal representative.

Exclusion Criteria:

* Previous chemotherapy with capecitabine
* Pre-existing patients with neuropathies
* Patients with known allergic reactions to any of the ingredients of the investigational product
* Patients with dermatological conditions that affect the hands or feet
* Patients with rectal neoplasia and indication for neoadjuvant treatment.
68Ga-DOTA-NOC PET/CT in Patients With Idiopathic Pulmonary Fibrosis

The investigators aim to evaluate the role of 68Ga-DOTA-NOC PET/CT in patients with idiopathic pulmonary fibrosis, in particular in patients with a diagnosis of IPF/UIP (idiopathic pulmonary fibrosis, diagnosed based in the American Thoracic Society and European Respiratory Society criteria) and in forms of NSIP (non-specific interstitial pneumonia). PET/CT imaging data will be compared with HRCT (high-resolution computed tomography) findings to assess disease extension, early disease detection and to non-invasively detect somatostatin receptors expression at lung level in these patients, with potential therapeutic implications.

Idiopathic pulmonary fibrosis prognosis remains severe, in particular for IPF, the most common entity. Moreover, current treatment options are largely ineffective and do not change the natural course of the disease. Pre-clinical evidence supports somatostatin receptors expression in the lung of patients with IPF. Recently new PET tracers (Somatostatin analogues labelled with 68Gallium), specifically binding to somatostatin receptors, have been developed and are used in neuroendocrine tumours clinical trials.

Aim of the present study is to evaluate the role of 68Ga-DOTA-NOC PET/CT in patients with idiopathic pulmonary fibrosis, in particular in patients with IPF/UIP and in cases with NSIP, that are characterized by a more indolent progression. PET/CT data will be compared with HRCT findings for the early detection of fibrotic areas and to non-invasively assess somatostatin receptors expression at lung level in these patients, with potential therapeutic implications. Moreover, the SUVmax (maximum standardized uptake value) will be analyzed in comparison with disease site and extension on HRCT.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of IPF and NSIP, based on the American Thoracic Society/European Respiratory Society Consensus Conference
* age ≥ 18 years
* males/females
* signed informed consent

Exclusion Criteria:

* pregnancy
* breast feeding
* healthy volunteers
* paediatric cases
* patients in emergency situations
* patients legally incompetent
* patients who refuse to sign the informed consent
Optimization of Radiation Protection Through Genomic Analyses

The long-term goal is to define "signatures" in the form of genomic changes through sequence analyses of genomic DNA using modern Next Generation Sequencing (NGS) methods, which

1. determine the radiation exposure of humans.
2. provide information about the exposure (dose).
3. determine the radiation quality.
4. predict the repair capacity and radiation resistance of an individual.

The planned research work will investigate structural changes in DNA caused by loosely ionizing and high-LET (Linear Energy Transfer) radiation as well as their attribution to double-strand break repair pathways, which will be analysed in parallel using modern microscopy methods. Our aim is to incorporate sequencing technologies into the spectrum of methods used in radiation research and radiation protection. It is important for us to consider the practical requirements of radiation protection and to extend our experimental approaches to cell types relevant to radiation protection. For this reason, we have now created a separate work program that will focus specifically on sequence analyses in irradiated human lymphocytes. The aim is to successfully transfer the experimental approaches and bioinformatic analyses established in previous experiments in human skin fibroblasts to lymphocytes. Subjects can donate blood samples on a voluntary basis at predetermined times. Only subjects without previous radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc. and without a previous tumor diagnosis in the medical history and in good performance status (ECOG 0-1) will be included.

Eligibility Criteria:
Inclusion Criteria:

ECOG 0/1 no prior treatment no prior cancer diagnosis thoracic or head and neck cancer

Exclusion Criteria:

prior treatment (chemotherapy, radiotherapy, etc.) prior cancer diagnosis