cyrilzakka/clinical-trials huggingface dataset:
A Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Patients With Advanced Pancreatic Cancer

The purpose of this study is to determine the safety and efficacy of an investigational study drug DN-101 (calcitriol) when given in combination with gemcitabine ± erlotinib in the treatment of pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of locally advanced and unresectable, or metastatic pancreatic cancer
* Performance status 0, 1,or 2
* Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

* Prior chemotherapy or radiation therapy for pancreatic cancer
* Prior treatment for other cancers in last 6 months
* Cancer of the brain or spine
* Active uncontrolled infection
* Hypercalcemia
Intubation and Ventilation Skill Training Using Modified Peyton's Four-Step Approach

Endotracheal intubation and mask ventilation procedural skills are basic skills which have to be learnt by medical student and have to be practiced directly. However, during COVID-19 pandemic, offline training was difficult to be conducted and new specific learning method has not established yet. The study aims to assess the effectiveness of modified Peyton's four-step approach, which can be implemented through online training, compared to the classic Peyton's four-step approach in learning endotracheal intubation and mask ventilation procedural skills.


Eligibility Criteria:
Inclusion Criteria:

* Preclinical students of Faculty of Medicine Universitas Indonesia agreed to participate and signed the consent
* Preclinical students of Faculty of Medicine Universitas Indonesia registered to attend every training session of endotracheal intubation and mask ventilation under Basic Clinical Skills module
* 100% attendance in every session

Exclusion Criteria:

* Students who have attended endotracheal intubation and mask ventilation training beforehand
* Students who have learnt endotracheal intubation and mask ventilation under Basic Clinical Skills module beforehand

Drop out Criteria:

* Preclinical students of Faculty of Medicine Universitas Indonesia who quit from Basic Clinical Skills module during research
* Students who have never attended the training session
Monaldi Hospital Rhythm Registry

The study is a prospective registry. Consecutive patients with indications of implant / replacement or upgrade of pacemaker (PM), implantable cardioverter defibrillator (ICD), Implanted loop recorder (ILR) will be enrolled.

The primary objective of the study is to describe the clinical events during a long-term follow-up of non-selected population of patients implanted with an PM, ICD or ILR.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients underwent PM/ICD/ILR implantation
* Patient is willing and able to sign an authorization to use and disclose health information or an Informed Consent
* Patient must be able to attend all required follow-up visits at the study center for at least 12 months

Exclusion Criteria:

* No informed consent
* Patient is participating in another clinical study that may have an impact on the study endpoint

Exclusion Criteria:

* No informed consent
The Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps

The aim of our study is to analyze the advantages of the prophylactic use of hemoclips before polypectomy in our usual clinical practice, through a prospective randomized study that determines their effectiveness compared to conventional polypectomy, assessing the decrease in immediate and delayed post-polypectomy bleeding

The methods for preventing post-polypectomy bleeding (PPB) are not standardised and there are groups that use hemoclips for this purpose.

The aim of our study is to analyze whether the use of hemoclips reduces PPB complications. It is a prospective, randomised study of patients with pedunculated polyps larger than 10mm. The patients were included in two groups (hemoclip before polypectomy -HC- and standard polypectomy -SP-)

Eligibility Criteria:
Inclusion Criteria:

* Patients with one or more pedunculated polyps, the heads of which measured more than 1cm (regardless of the stalk thickness and length), and they were compared against the size of the biopsy forceps (6mm) and subsequently confirmed in the anatomical specimen
* Not to have any hemostatic alterations at the time the endoscopy was performed (confirmed by the usual blood tests taken before the procedure).

Exclusion Criteria:

* Patients younger than 18 years of age
* Patients with a platelet count of less than 50000, INR larger than 1.5
* Patients who refused to give their informed consent.
Effects of COVID-19 Hospitalization on Physical Performance

Coronavirus disease (COVID-19) has resulted in millions of hospital admissions. The physical consequences caused by COVID-19 hospitalization could jeopardize the overall health status of patients through a decrease in functional capacity. A therapeutic exercise program may reduce the adverse effects of COVID-19 on functional capacity and thereby improve the overall health status of these patients.

The objectives of this project are 1) to analyze the effect of a therapeutic exercise program in patients who have been hospitalized in Intensive Care Unit (ICU) for COVID-19.

Single-blind randomized clinical trial. 118 patients post-ICU for COVID-19 will be randomized into an intervention group and a control group. The intervention group will perform a therapeutic exercise program for eight weeks in telematic modality. Functional capacity will be analyzed using the grip strength, Short Physical Performance Battery, gait speed, lower extremity strength and the FRAIL scale at baseline, eight and twelve weeks. The main statistical analysis will be a comparison of means for independent samples assessing the effect of the intervention.

Given the high prevalence of patients hospitalized for COVID-19, establishing strategies to minimize the adverse effects of the virus on patients is a must for the healthcare setting. Assessing physical condition after COVID-19 will allow the magnitude of the problem to be established. Physiotherapy, through therapeutic exercise, could improve physical fitness in these patients and thus improve the overall health status after COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Have been diagnosed COVID-19 positive at the time of hospital admission.
* Be able to use an online platform to conduct "meetings" with the healthcare professional or have the necessary personal assistance to do so.
* Be able to read the informed consent form and understand the objectives and conduct of the study.

Exclusion Criteria:

* Diagnosed neurological or psychiatric disease.
* Contraindications to physical exercise.
* Failure to give informed consent for the study.
* Unavailability to perform the ET program twice a week.
The Effect of Dexmedetomidine on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery

Acute kidney injury(AKI) is a common and severe complication after the cardiac surgery. Postoperative AKI increases the in-hospital stay, intensive care unit(ICU) stay and postoperative mortality. Aortic surgery is the most risky surgery that causes the postoperative AKI, and the incidence of AKI after aortic surgery is about 50%.

The α1- and α2-adrenergic receptors in the kidney modulate vasoconstrictor and vasodilatory effects, respectively. Agents that attenuate renal vasoconstriction may have potential as renoprotective drugs because vasoconstriction most likely contributes to the pathophysiology of AKI. Clonidine, an α2-agonist, has been shown experimentally to inhibit renin release and cause a diuresis, and it has been evaluated in an experimental AKI model, confirming its potential as a renoprotective agent. Furthermore, it has been already reported that dexmedetomidine, α2-agonist, reduce the impairment of renal function after cardiac operation.

The aim of this study is to examine the association between preoperative dexmedetomidine infusion and the incidence of postoperative acute kidney injury(AKI) in patients undergoing aortic surgery.


Eligibility Criteria:
Inclusion Criteria:

1. the patients undergoing ascending, arch and/or proximal descending aorta surgery with cardiopulmonary bypass
2. 20 - 100 yrs old

Exclusion Criteria:

1. having preoperative severe renal dysfunction (eGFR \< 15 ml/min per 1.73m2)
2. Left ventricular-ejection fraction \< 30%
3. Preexisting congestive heart failure
4. Severe coronary artery disease
5. Hemodynamically unstable arrhythmia
6. Cardiogenic shock during perioperative period
7. Ventricular assist device use
8. cannot communication because of a language barrier or illiteracy
Efficacy and Safety of 14-day Concomitant Therapy for Difficult-to-Treat Helicobacter Pylori Infection

The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the treatment of Hard-to-treat Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates

Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted.

This study aims to propose a new concomitant therapy for the patients with three or more treatment failure, and then evaluates whether adverse effects are tolerable.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 with persistent H. pylori infection.
* Patients failed at least three different standard eradication therapies before.Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.

Exclusion Criteria:

* Patients treated with H2-receptor antagonist, PPI, vonoprazan,bismuth and antibiotics in the previous 4 weeks.
* Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.
* History of allergy to any of the drugs used in the study.
* Severe concomitant cardiovascular, respiratory, or endocrine diseases,clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.
* Currently pregnant or lactating.
* Severe neurologic or psychiatric disorders.
* Alcohol abuse or drug addiction.
* Patients with compliance lower than 90% in any previous treatment are not included.
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Adaptive Support Ventilation in Acute Respiratory Distress Syndrome

The purpose of this protocol is to compare standard of care lung protective ventilation settings with an automated ventilator setting, called Adaptive Support Ventilation (ASV), in patients with acute respiratory distress syndrome (ARDS). This study will compare measurements (i.e. tidal volumes, driving pressure, respiratory rate (RR), compliance, peak airway pressures, plateau pressures, PEEP) with each ventilator technique, and will measure esophageal pressures to compare transpulmonary and respiratory system mechanics.

This study will compare two different modes of mechanical ventilation: standard lung protective controlled mandatory ventilation and Adaptive Support Ventilation. The investigators will enroll adult patients with ARDS who are mechanically ventilated and admitted to intensive care units, capturing a population with respiratory failure and significant critical illness. Patient mechanics during each ventilation strategy will be compared before and after crossover.

After obtaining informed consent, the investigators will place an esophageal balloon which will be used for simultaneous measurements of airway pressures (Pao) and esophageal pressures (Pes), to estimate transpulmonary pressures (PL = Pao - Pes), while also measuring Flow and Volume. Use of esophageal balloon catheters is common practice in the ICUs, and standard of care at Beth Israel Deaconess Medical Center is to use these balloons in patients with ARDS. Both the respiratory therapy and physician staff are very comfortable with placement and use. The esophageal balloon will be left in place until extubation. If the balloon is dislodged or removed for clinical purposes, it will not be replaced solely for research purposes unless it occurs on the first day of study measurements.

Patients will then be randomized to be switched to ASV immediately or to be maintained on their current lung protective ventilation settings.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years of age
2. Receiving mechanical ventilation in an intensive care unit
3. ARDS, as defined by the Berlin definition:

   1. Hypoxemic respiratory failure with PaO2 / FiO2 ratio \< 300 mmHg
   2. Bilateral alveolar/interstitial infiltrates on chest x-ray, with opacities not present for more than 7 days
   3. Respiratory failure not fully explained by cardiac failure or fluid overload
   4. Intubation on mechanical ventilation and receiving PEEP ≥ 5 cm H2O
4. Receiving mechanical ventilation from a Hamilton ventilator, on a controlled mode of ventilation.

Exclusion Criteria:

1. Clinical team refusal
2. Esophageal injury or contraindication precluding placement of the esophageal balloon
14-3-3η Protein, Disease Activity and Bone Mineral Density, in Female Patients With Rheumatoid Arthritis

Is to investigate the relation between 14-3-3η protein, disease activity, and bone mineral density in female patients with rheumatoid arthritis.

Methods: all patients in the study will subject to:

* Clinical assessment, WT, Height ,BMI, parity, medications,
* DAS 28.
* Serum 14-3-3η protein.
* DEXA scan.

Grouping:

* Group I: RA Patients with low BMD.
* Group II: RA Patients with normal BMD.
* Group III: normal control.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis according to ACR 2010 criteria with at least one year duration.
* Premenopausal females.
* On conventional DMARD with maximum 5 mg steroids.

Exclusion Criteria:

* Biological treatment.
* Previous antiresorptive treatment, or bone anabolics.
* High dose corticosteroid.
* Chronic renal or kidney disease.
* Medications affecting bone metabolism.
* Thyroid or adrenal dysfunction,
Short Term Effects of PRX-03140 in Patients With Mild Alzheimer's Disease Being Treated With Aricept

This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRX-03140 administered orally once daily for 14 days in subjects with mild Alzheimer's Disease who are using a stable, well-tolerated 10 mg dose of Aricept (donepezil) but continue to experience worsening AD symptoms.


Eligibility Criteria:
Inclusion Criteria:

* At least 60 years old.
* On a stable 10 mg dose of Aricept for at least 90 days and able to take it in the morning.
* Diagnosis of probable Alzheimer's Disease.
* Mild dementia.
* You or your authorized representative provide voluntary written informed consent.
* Not pregnant, planning a pregnancy, or capable of becoming pregnant.

Exclusion Criteria:

* Any other medical condition which, in the opinion of the Investigator, would jeopardize your safety, impact the validity of the study results, or interfere with your ability to complete the study according to the protocol.
* Intolerance to Aricept.
* Dementia other than Alzheimer's type.
* Parkinson's Disease.
* History of seizure or epilepsy.
* History of stroke.
* Participation in another research study within last 30 days.
* Enrollment in any previous research study testing PRX-03140.
* Use of prescription cognitive enhancing medications (except Aricept) or MAO inhibitors within last 4 weeks.
* Use of tobacco products within last 4 weeks.
* Positive blood screen for Hepatitis B surface antigen or Hepatitis C antibody.
* Positive urine screen for alcohol or drugs of abuse or history of drug or alcohol abuse within last 6 months.
* Major surgery within last 4 weeks.
A Study on Children With COVID-19 Admitted at Assiut University Children Hospital

The aim of study is to: 1-describe demographic and clinical data of children infected with COVID-19 admitted at isolation unit of Assiut university children hospital 2- assess the risk factors responsible for complications of COVID-19 in children 3-assess the outcome of COVID-19 in children admitted at AUCH.

In December 2019, reports emerged of a cluster of cases of pneumonia of unknown cause in Wuhan, China, culminating in the identification of a novel coronavirus on 12 January 2020, denoted as severe acute respiratory syndrome coronavirus 2 (SARSCoV-2), and the associated disease as coronavirus disease 2019 (COVID-19) (1).

Some cases of infection in children have also been reported (2) the symptoms of pediatric COVID-19 are mild, the decrease in lymphocytes is not obvious and severe cases are rare. Initially, children comprised between 1% and 2% of the laboratory-confirmed SARSCoV-2 detections among people in China (3), Italy (4), and the United States (5). Initial reports from (CDC) noted the following age distributions: 15-17 years (32%), 10-14 years (27%), 5-9 years (15%), 1-4 years (11%), and \<1 year (15%), with a median age of 11 years (5).

Diagnosis of COVID-19 will depend on the clinical presentation of the case and on laboratory test as well as radiological finding. The cases will be stratified according to these collective data to different grades of severity (6). Investigations for suspected case: CBC and radiology, to confirm diagnosis: Nasopharyngeal swab for PCR and to assess severity: Serum ferritin, D dimer, LDH, and CRP. (7) Current treatment for COVID-19 is mainly supportive care (8).The decision of the site of management either at home or in hospital depends on the clinical presentation, requirement for supportive care, potential risk factors for severe disease, and the ability of the patient to self-isolate at home(9) (10).

Eligibility Criteria:
Inclusion Criteria:

* All children (up to 18 years) diagnosed with COVID-19 admitted at Isolaton Unit of Assiut university children hospital through the period from 1st January 2021 to 31st December 2022

Exclusion Criteria:

* Clinically suspected patients approved by CT chest and PCR not infected with COVID-19.
Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer

This multi-site study is being conducted to examine dietary and activity patterns, body composition, blood and quality of life in breast cancer patients. The study will recruit 176 women with MBC in Milwaukee (n=88) and Chicago (n=88).

Aims/Objectives

Aim 1. To examine the efficacy of the Every Day Counts intervention in producing significant post-intervention changes in multidimensional QOL in women with MBC.

Hypothesis 1: Women randomized to the immediate EDC intervention (n=88) will exhibit greater improvements in multidimensional QOL compared to women randomized to the attention control (n=88).

Aim 2. To investigate the mechanistic effects of the Every Day Counts intervention on body composition, adipokines, serum biomarkers of inflammation and insulin sensitivity.

Hypothesis 2: The EDC intervention leads to improved QOL through mediating factors including body composition, prognostic serum biomarkers of inflammation and/or insulin resistance.

Exploratory Aim 3: To explore if microRNA (miRNA) signatures associated with inflammation and/or Metabolomics are altered with the EDC intervention.

Hypothesis: miRNAs identified in our pilot study (miR-10a-5p, miR-205-5p, and miR-211-5p) that regulate inflammation and/or Metabolomics will be related to QOL improvements and can identify women more likely to respond to lifestyle changes.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years), female
* Confirmed Metastatic Breast Cancer
* Patients clinically stable with treated brain metastases are eligible
* Written documentation from their oncologist permitting study participation
* Determined to be "clinically stable" by their medical oncologist (i.e., no unintentional weight loss, no new symptoms or change in performance status for the past 4 weeks, no clinical \[including laboratory\] or radiologic evidence of disease progression, no recent or planned change in anti-neoplastic therapies, no reports of severe pain \[≥ Grade 3 per the NCI CTCAE)
* Life expectancy \>6 months

  -Written documentation from their oncologist permitting study participation
* Access to a mobile phone
* Understand/speak English fluently.
* Non-adherence to ACS nutritional or PA guidelines for cancer survivors as documented by questionnaire.

Exclusion Criteria:

* Does not meet the above criteria.
Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y001#

An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma


Eligibility Criteria:
Inclusion Criteria:

1. According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.
2. Subjects must have previously received at least 3 anti-myeloma regimens. Subjects must have documented disease progression (according to IMWG criteria) during or within 12 months of completing their last anti-myeloma regimen prior to study entry; and prior regimens must have included proteasome inhibitor (PI) and immunomodulatory drug (IMiD).
3. Measurable disease as defined by the protocol
4. ECOG score is 0 or 1.
5. Expected survival time ≥12 weeks.

Exclusion Criteria:

1. Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants drugs.
2. Patients who received autologous hematopoietic stem cell transplantation (ASCT) or prior allogeneic hematopoietic stem cell transplantation (ALLo-HSCT) within 12 weeks prior to mononuclear cell collection.
3. No unmobilized mononuclear cells can be collected for CAR T cell production.
4. Screening subjects who were receiving systemic steroids during the previous 7 days or who were determined by the investigator to require long-term systemic steroid use during treatment (except for inhaled or topical use, except at doses \< 10mg/ day).
5. Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg).
A Multi-domain Approach for the Characterization and Early Diagnosis of Neurodevelopmental Disorders

Diagnosis and characterization of neurodevelopmental disorders are considered challenging processes because of their complexity, multi-factoriality and heterogeneity. The present project will consider two of the most common neurodevelopmental disorders (i.e. autism spectrum disorders (ASD) and language disorders (LD)), with the aim to overcome these difficulties, by: a) deeply investigating their neuronal correlates; b) identifying multi-domain biomarkers (electrophysiological, genetic, environmental and clinical); c) developing a machine learning algorithm for early diagnosis. To achieve the above mentioned aims a multi-domain dataset will be used, comprising data collected from typically developing infants, infants at high risk for ASD and infants at high risk for LD. The data that will be used have been already collected within other trials performed at the Scientific Institute E. Medea.


Eligibility Criteria:
Inclusion Criteria:

* APGAR scores at birth at 1' and 5' \> 7;
* newborn screening otoacoustic emissions in the norm;
* absence of neurological disorders;
* Italian as the language mainly spoken in the family nucleus.

Exclusion Criteria:

* APGAR scores at birth at 1' and 5' \<= 7;
* newborn screening otoacoustic emissions not in the norm;
* presence of neurological disorders;
* non-Italian native speaker