cyrilzakka/clinical-trials huggingface dataset:
Clinical Outcome of Patients With COVID-19 Pneumonia Treated With Corticosteroids and Colchicine

Cross sectional study of 301 adult patients with Covid-19 Pneumonia treated with corticosteroid and/or colchicine

A cross sectional study of 301 adult patients with Covid-19 Pneumonia confirmed by Real-Time Polymerase Chain Reaction for SARS-CoV2 (RT-PCR SARS-CoV2), Berlin protocol, who required hospitalization in three hospitals in Antioquia, Colombia. Patients were treated according to the institutional protocol (from March 20, 2020 to June 30, 2020) with corticosteroid if the patient required supplemental oxygen. From July 1, 2020, the management protocol changed with the addition of colchicine to all patients admitted to the institutions. The treatment was supervised and monitored by the same specialist in infectology of the institutions.

We describe the clinical manifestations and outcomes of the patients who received these treatments. The patient's information was analyzed according to the outcome of interest (alive/dead) with univariate, bivariate, and multivariate measures to adjust the variables that presented statistical association.

Eligibility Criteria:
Inclusion Criteria:

* The included patients were older than 18 years hospitalized for Covid-19 Pneumonia, confirmed positive by Real-Time Reverse Transcription Polymerase Chain Reaction for SARS-CoV2 (RT-PCR SARS-Cov2) by Berlin protocol. The samples were taken from a nasopharyngeal swab.
* The patients should also have radiological confirmation of Pneumonia, mostly chest tomography or chest X-rays, to support the diagnosis of Covid-19 Pneumonia.

Exclusion Criteria:
Patient Stratification and Treatment Response Prediction in Neuropharmacotherapy Using Hybrid Positron Emmission Tomography/Magnetic Resconance Imaging (PET/MR)

Selective serotonin reuptake inhibitors (SSRIs) raise serotonin (5-HT) in the synaptic cleft and are the current first line of pharmacological antidepressive treatment. Yet, there is a missing link between this first molecular step in their mechanism of action and observed clinical improvement. We have determined to establish a framework combining genuine molecular and functional imaging, i.e. hybrid pharmaco-PET/MR imaging, of the human serotonergic system in order to predict antidepressant treatment response.

Objectives:

1. To predict antidepressant treatment response from data obtained using hybrid PET/MR with acute pharmacological challenge.
2. To discriminate healthy from depressed subjects using this paradigm.
3. To establish models connecting regional changes in occupancy of serotonin transporters (5-HTT) following citalopram infusion, with changes in brain activation and connectivity of major resting-state hub networks.

Design: Randomized, double-blind, placebo-controlled, cross-over mono-center study.

Materials and methods:

40 major depressed (MDD) and 40 healthy subjects will undergo 2 PET/MR scans on a 3T SIEMENS mMR Biograph scanner: 1. challenge with citalopram 8mg 2. placebo (saline). After structural imaging, functional MRI will be continuously acquired. \[11C\]DASB will be applied using a bolus + constant infusion paradigm to probe 5-HTT binding potentials and monitor 5-HTT occupancy with drug challenge, applied after 70min, in a single session. Scanning will be terminated 80min after challenge. MDD patients will receive subsequent escitalopram treatment with repeated evaluation of response for 3 months.


Eligibility Criteria:
Inclusion Criteria:

* General health based on medical history, physical examination and structured clinical interview for DSM-IV (SCID)
* HAM-D≥18 (patients)
* Willingness and competence to sign the informed consent form
* Age 18 to 55 years

Exclusion Criteria:

* Any medical, psychiatric or neurological illness (other than MDD)
* Current or former psychopharmacological treatment
* Current or former substance abuse
* Pregnancy
* Any implant or stainless steel graft or any other contraindications for MRI
* Failure to comply with the study protocol or to follow the instructions of the investigating team
* Participation in studies involving radiation exposure in the past 10 years.
* Body mass index \<17 or \>30
RW Efficacy of Sotorasib in KRAS G12C-mutated Metastatic NSCLC

The purpose of the IFCT2102 Lung KG12Ci study is to closely monitor cohort ATU applications in order to collect retrospectively, as soon as possible after inclusion and under real-life conditions, the efficacy data on sotorasib (AMG 510) as well as the demographic and molecular characteristics of patients.

The purpose of the IFCT2102 Lung KG12Ci study is to closely monitor cohort ATU applications in order to collect retrospectively, as soon as possible after inclusion and under real-life conditions, the efficacy data on sotorasib (AMG 510) as well as the demographic and molecular characteristics of patients.

The objective of this retrospective observational, multicenter, cohort study is to describe, in real life, the characteristics and evolution of NSCLC patients with a KRAS G12C mutation, treated with sotorasib in the framework of the cohort ATU in France.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Stage IV NSCLC at time of initiation of treatment with sotorasib
* Presence of KRAS G12C mutation diagnosed on tumor sample and/or on liquid biopsy (co mutations allowed)
* Patients who received at least one dose of the treatment with sotorasib as part of the French Early Access Program (ATU program)
* Patients who were informed about the study and do not object for their data to be collected
* Age \> 18 years

Exclusion Criteria:

* Patients enrolled in a sotorasib clinical trial
* Patients with a psychiatric history that hinders the comprehension of the information leaflet
* Patients under curatorship or guardianship
* Unable to obtain data collection
MRI Evaluation of Iron Overload in the Heart, Liver and Pancreas in Patients Receiving Multiple Blood Transfusions.

Sickle cell anemia and Sickle cell β thalassemia patients require multiple transfusions in order to avoid chronic anemia sequel. This regimen entails intrinsic deleterious effects, the majority of which are related to iron deposition in the reticuloendothelial system. Thus, iron is deposited in hepatic, myocardial and endocrine glands tissues. Tools available for iron load evaluation include serum ferrtin levels, liver biopsy and echocardiography, all are non specific.

The purpose of this work is to compare iron overload in the liver, heart and pancreas in Sickle cell anemia and Sickle cell β thalassemia patients using T2\* MRI sequences.

Sickle cell anemia and Sickle cell β thalassemia patients recieving multiple transfusions are exposed to the effects of iron deposition in the reticuloendothelial system, including cardiac muscle, liver and pancreas. Tools available for iron load evaluation include serum ferrtin levels, liver biopsy and echocardiography, all are non specific.

The purpose of this work is to compare iron overload in the liver, heart and pancreas in Sickle cell anemia and Sickle cell β thalassemia patients using T2\* MRI sequences.

Patients and Methods: 27 Sickle cell anemia and 28 Sickle cell β thalassemia will undergo transthoracic echocardiography, cardiac MRI using T2\* sequences and clinical and laboratory evaluation for iron overload including ferritin levels and oral glucose tolerance test

.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Sickle cell anemia or Sickle cell β thalassemia having received multiple blood transfusions.

Exclusion Criteria:

* contraindication to MRI
Study of Tumor Samples From Patients With Ependymoma Treated on the Children's Oncology Group ACNS0121 Trial

This research trial studies tumor samples from patients with ependymoma treated on the Children Oncology Group ACNS0121 trial. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PRIMARY OBJECTIVES:

I. To examine the prognostic role of histopathological variables, in particular cellular density, mitotic count, and tumor cell invasion in intracranial pediatric ependymomas.

II. To study whether hTERT expression and telomere dysfunction correlate with progression-free survival (PFS) and overall survival (OS) in pediatric intracranial ependymoma.

III. To perform a genome-wide copy number screen and validation of copy number abnormalities (CNAs) on formalin-fixed paraffin-embedded (FFPE) ependymomas using Affymetrix Molecular Inversion Probe (MIP) arrays and interphase fluorescence in situ hybridization (iFISH). IV. To evaluate associations between infiltration of immune markers and PFS as well as OS in pediatric ependymoma.

V. To examine the role of 1q gain and 9p deletion in pediatric ependymomas by exploring their association with PFS and OS in a multivariable model.

VI. To establish the frequency and clinicopathological associations of mutations in genes involved in Notch pathway signaling.

OUTLINE:

Archived tumor tissue samples are analyzed for cellular density, mitotic count, tumor cell invasion, hTERT expression, telomere dysfunction, 1q gain, 9p deletion, and genetic mutations by IHC, Affymetrix Molecular Inversion Probe (MIP) arrays, and fluorescence in situ hybridization (FISH). Results are then correlated with patient-outcome variables and known risk factors, namely gender, age at diagnosis, tumor location infratentorial vs. supratentorial), tumor grade (differentiated vs anaplastic), and extent of surgery as well as pathologic variables.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ependymoma and treated on COG-ACNS0121
* Previously collected tumor samples banked at the Children Oncology Group BioPathology
Partially Hydrolyzed Whey Formula in Cow's Milk Allergic Patients

Cow's milk (CM) allergy is the most common food allergy in children, affecting 2-3% of infants. In formula-fed infants with CM allergy, extensively hydrolyzed or amino acid-based infant formulas are typically recommended. These formulas are expensive and not palatable. For older patients with CM allergy, the standard of care is avoidance of all CM products. The investigators cared for a CM allergic patient who was able to tolerate partially hydrolyzed whey formula (pHWF), which tastes better and is less expensive than extensively hydrolyzed or amino-acid based formulas. There are likely other subjects who could similarly tolerate pHWF. Furthermore, it is possible that taking pHWF could accelerate tolerance of CM. The investigators aim to identify characteristics of CM allergic subjects who can tolerate pHWF and assess the degree to which taking pHWF accelerates CM tolerance.

Specifically, subjects who have CM allergy will be enrolled. The investigators will perform an oral food challenge (OFC) to pHWF in each subject. Subjects who pass the challenge will be placed on pHWF for 2 years. Subjects who do not pass the challenge will receive routine care. The investigators will perform allergy skin testing, specific IgE measurement, other serologic assays, and longitudinal OFCs to profile subject characteristics in the two groups at baseline and over time.

Eligibility Criteria:
Inclusion Criteria:

* age 0.5-18 years old
* positive skin prick tests (SPT) or detectable serum milk specific IgE and a history of an allergic reaction to milk within 6 months before study screening; or milk-specific IgE level or SPT highly predictive for clinical reactivity (if ≤ 2 years old, sIgE \>2 kU/L; if \> 2 years old, a level \>5 kU/L; SPT wheal diameter ≥ 3 mm)
* a clinical reaction during the cows milk oral food challenge

Exclusion Criteria:

* negative SPT and undetectable milk-specific sIgE
* unstable asthma, allergic rhinitis, or atopic dermatitis
* milk-induced eosinophilic gastroenteropathy
* recent reaction to partially hydrolyzed whey formula
* history of severe anaphylaxis with hypotension to cows milk
* participation in any interventional study for the treatment of food allergy in the 6 months prior to screening visit
* inhalant allergent immunotherapy that has not yet reached maintenance dosing
* inability to discontinue antihistamines for skin testing, OFC
* any systemic therapy which in the judgment of the investigator could be immunomodulatory in the 12 months prior to visit 1 (xolair, rituximab, chronic steroids, etc)
* investigational drug use 90 days prior to visit 1 or intention to use during study period
* the presence of any medical condition that the investigator deems incompatible with participation in the trial.
* unable to understand and speak English
Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients

This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female who over 19 years old
* Moderate to Severe Dry Eye Disease Patients
* Must meet all criteria listed below at least in one eye or both eyes.

  1. TCSS (National eye institute (NEI) scale)≥ 4
  2. Ocular discomfort score (ODS) ≥ 3
  3. Schirmer test(without anesthesia) ≤ 10mm in 5 mins
  4. Tear break-up time ≤ 6 secs
* Written informed consent to participate in the trial

Exclusion Criteria:

* Those who have clinically significant eye disease not related to dry eye syndrome
* Those who have worn contact lenses before 1week Screening visit or have to wear contact lenses or need to wear contact lenses during study period
* Those who have medical history with intraocular surgery 12months before screening visit
* Use of corticosteroid, beta blocker and anticholinergic agent within 4 weeks
* Participation in other studies within 4weeks of screening visit
Treatment Effects Inclusive Cognitive Impact and Possibilities to Individually Adjusted Treatment in Patients With Intracranial Tumors With Clinical, Neuropsychological and Imaging Parameters

The main purposes with this trial is to investigate the potential of MRI with diffusion and blood volume, flow in brain to diagnose and to measure treatment effects in patients with intracranial tumors, especially gliomas and metastases in a prospective trial, to evaluate the possibilities to individually adjusted treatment in this category of patients depending on treatment outcomes measured by MRI, to perform clinical follow up in connection with MRI to evaluate a correlation and to perform testing of cognitive ability before, during, and after treatment and to investigate if given treatment causes any decrease in the patients habitual state.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Suspected primary brain tumor, verified glioblastoma or non surgically treated metastases from solid tumor
* Increasing MRI changes in patients with previous verified glioblastoma
* Be able to speak Swedish without difficulties (because of the neuropsychological investigations)
* Written informed concent

Exclusion Criteria:

* Unability to perform MRI
Impact of Black Seed Oil on Hemodialysis Patients

The aim of the study is to evaluate the effect of black seed oil on endothelial dysfunction, oxidative stress and quality of life in hemodialysis patients.

Evaluation of the effect of black seed oil in hemodialysis patients via:

* Evaluation of serum Endothelin-1 levels
* Evaluation of serum Malondialdehyde (MDA) levels
* Evaluation of serum Total Antioxidant Capacity (TAC) levels
* Evaluation of Quality of Life (QOL)
* Evaluation of fatigue scale

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years old
* Three to four times per week hemodialysis
* Being on hemodialysis for at least 6 months
* Ability and willingness to cooperate in the study

Exclusion Criteria:

* Pregnancy or lactation
* Cigarette smoking or substance/alcohol abuse
* Having active infectious diseases
* Receiving steroidal or nonsteroidal anti-inflammatory drugs
* Using Nigella sativa oil regularly
* Changes in treatment methods (dialysis) or medications during the supplementation
Phenotypes of Preschool Wheezing Among Children Attending Sohag University Hospital

Wheezing in preschool children is very common, with a wide differential diagnosis. It is essential to be sure of the exact sound that parents are describing; the term 'wheeze' is often applied to non-specific sound.Approximately one-third of children are diagnosed with wheeze in the first 3 years of life, making wheeze one of the commonest respiratory symptoms.The differential diagnosis of wheeze is wide, and different management strategies are needed depending on the underlying phenotype. The word 'wheeze' is used to describe many different sounds. That can be heard by both clincians and parent. Even if true wheeze is heard, this should not be automatically assumed to be due to bronchospasm. Airway narrowing by mucus will produce true wheeze but does not respond to bronchodilators. Similarly, airway malacia, either related to intrinsic airway wall defects or loss of alveolar tethering points, are also causes of bronchodilatorunresponsive wheeze; indeed, bronchodilators, by reducing airway smooth muscle tone, may actually worsen airway narrowing.


Eligibility Criteria:
Inclusion Criteria:

* patients from the age of one to five years with recurrent wheezing

Exclusion Criteria:

* Children above 5 years and below one year old.
* Failure to obtain informed consent.
* Children below 6 years with chest diseases other than wheezing
Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis

OBJECTIVES:

I. Determine the maximum tolerated dose of vasoactive intestinal peptide in patients with acute respiratory distress syndrome.

II. Evaluate the safety and pharmacodynamic activity of this peptide in these patients.

PROTOCOL OUTLINE:

This is a dose escalation study.

Patients receive vasoactive intestinal peptide (VIP) IV over either 6 or 12 hours.

Cohorts of 3 patients each receive escalating doses of VIP over either 6 or 12 hours until the maximum tolerated dose is determined.

Patients are followed for 30 days.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of adult respiratory distress syndrome (ARDS) with sepsis

ARDS characterized by: hypoxemia refractory to supplemental oxygen therapy, diffuse pulmonary infiltrates, no cardiogenic cause of pulmonary edema, and reduced pulmonary compliance

Sepsis characterized by: Two or more of the following: Fever or hypothermia; Tachycardia; Tachypnea; WBC greater than 12,000/mm3 or less than 4,000/mm3 or immature neutrophils; Hypotension; Clinical suspicion of infection; Inadequate organ perfusion or organ dysfunction as demonstrated by: Acute deterioration in mental acuity (excluding sedatives or other nonsepsis causes) OR Unexplained metabolic acidosis OR Oliguria for greater than 2 hours OR Unexplained coagulopathy (elevated PT or PTT or platelet count decreased to less than 50% of baseline within 24 hours or less than 100,000/mm3) OR Acute elevation of bilirubin to greater than 2.0 mg/dL AND elevation of alkaline phosphatase, SGOT, or SGPT

No sepsis with unstable BP

--Prior/Concurrent Therapy--

At least 30 days since prior enrollment in investigational trial; No other concurrent enrollment in investigational trial

--Patient Characteristics--

Hematopoietic: See Disease Characteristics; No uncontrolled hemorrhage (transfusion of 4 or more units required within past 24 hours); No chemotherapy induced neutropenia (granulocyte count less than 1000/mm3)

Hepatic: No severe liver disease with portal hypertension

Renal: No anuria (urine output less than 50 mL/day)

Cardiovascular: No cardiogenic shock

Neurologic: No recent stroke, head trauma, or increased intracranial pressure; No other serious neurologic disorder

Other: Not pregnant; No acquired immune deficiency syndrome; No immunosuppressed transplant patients; No severe burns; No irreversible underlying condition with rapidly fatal course; No marked obesity; No recent history of diarrhea
Left Ventricular Diastolic Function During Anesthesia Induction

Diastolic dysfunction is an important cause of hemodynamic instability in the perioperative field.Therefore this study aims to investigate the influence of existing diastolic dysfunction or deterioration of diastolic function on hemodynamic stability during induction of anesthesia and postoperative complications. The impact of different anesthetics on diastolic function is investigated.

In this prospective observational study two cohorts of patients with different anesthesia regimes are investigated. Anesthesia is maintained with sevoflurane or propofol. Before induction of anesthesia a transthoracic echocardiography is performed to examine systolic and diastolic function. Immediately after induction, during maintenance and after completion of anesthesia any changes of diastolic function are examined with transthoracic echocardiography. All anesthetic medications, fluids, vasoactive medications and catecholamines are registered.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 60 years scheduled for general anesthesia

Exclusion Criteria:

* Mitral regurgitation or stenosis \> I°
* Sp. mitral valve repair or replacement
* Pericardial effusion
* Atrial fibrillation/flutter
* Patients with pacemaker
* BMI \> 35 kg/m2
Local Inflammation in Arrhythmogenic Right Ventricular Cardiomyopathy

The understanding of ARVC pathophysiology remains incomplete. Several clues indicate that disease progression is mediated through inflammation. The present study aim to document the feasibility of detecting the potential presence of intracardiac local inflammatory components in patients with ARVC.

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a heritable condition characterized by right ventricular (RV) dilatation/dysfunction and malignant ventricular arrhythmias. The understanding of ARVC pathophysiology remains incomplete. Several clues indicate that disease progression is mediated through inflammation. First, presence of subepicardial late gadolinium enhancement sharing the same characteristics as the ones found in myocarditis is common on cardiac magnetic resonance imaging (CMR). Second, clinical pathology findings of inflammatory infiltrates of mononuclear cells are frequent and correlate to the extent and severity of ARVC. Finally, from a biological standpoint, the exploratory study conducted by Campian et al. has shown an exaggerated humoral inflammatory response in peripheral blood whilst anti-desmoglein-2 antibodies (targeting a component of the desmosome) emerge as a sensitive and specific biomarker for ARVC. As specific treatments for ARVC are currently lacking, a better understanding of the humoral pathophysiology of the disease could unlock new therapeutic targets. We recently demonstrated that collecting local cardiomyocytes was feasible through irrigated ablation catheters in patients with ARVC. These steerable catheters may easily map the whole right ventricle and locate endocardial or epicardial scars. Aspiration of local blood or cellular material through the inner lumen of the catheter once pressed on the parietal wall may be an interesting technique for retrieving local inflammation markers.

Eligibility Criteria:
Inclusion Criteria:

* For cases:

  * Arrhythmogenic right ventricular dysplasia diagnosed (according to 2010 Task Force Criteria)
  * Admitted for right ventricle electrophysiologic mapping
* For controls \* Admitted for ablation procedures (accessory pathway, atrial flutter) on otherwise healthy hearts.

Exclusion Criteria:

* Diagnostic of systemic chronic inflammatory disease
* Presence of possible or proven cardiac involvement of an inflammatory disease, an acute or chronic infectious disease.
* Taking immunosuppressant or immunomodulating medications