cyrilzakka/clinical-trials huggingface dataset:
Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections

To provide ganciclovir on a compassionate use basis to immunocompromised patients with serious cytomegalovirus (CMV) infections and to study safety and efficacy in this patient population.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Topical acyclovir.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Mild to moderate cytomegalovirus (CMV) infections that fail to satisfy the clinical severity criteria.
* Transplant where a trial reduction of immunosuppressive drug treatment is not feasible.
* Congenital or neonatal CMV infections where there is not documented congenital or acquired immunodeficiency.
* Neutropenia unless it is pre-existing.
* Thrombocytopenia unless it is pre-existing.

Concurrent Medication:

Excluded:

* Other myelosuppressive drugs such as cancer chemotherapy agents, interferon, foscarnet, or nucleoside analogs.

Patients with the following are excluded:

* Mild to moderate cytomegalovirus (CMV) infections that fail to satisfy the clinical severity criteria.
* Transplant where a trial reduction of immunosuppressive drug treatment is not feasible.
* Congenital or neonatal CMV infections where there is not documented congenital or acquired immunodeficiency.
* Neutropenia unless it is pre-existing.
* Thrombocytopenia unless it is pre-existing.

Patients must be immunocompromised with a serious cytomegalovirus (CMV) infection. This would include pneumonia, gastrointestinal disease, hepatitis, or other organ-specific disease or severe wasting syndrome. Patients with pre-existing neutropenia or thrombocytopenia, and immediate life-threatening disease can be included if the investigator believes that delay in starting ganciclovir therapy is not advisable. In such patients, the investigator must advise the patient of the risk of further marrow suppression and the increased risk of infection or bleeding; and the patient must sign an amended informed consent form.
Study of TB Lesions Obtained in Therapeutical Surgery

The correlation of the morphologic, microbiological, genetic and histopathological characteristics of TB lesions obtained in therapeutical surgery with the clinical forms and features of the patients will provide essential information

1. on the role of the host in the mechanisms associated to the generation and evolution of active TB and
2. about future diagnostic and/or prognostic biomarkers of TB disease. All this information could be used for patients stratification and/or to design new therapeutic strategies.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing therapeutical surgery for their Pulmonary Tuberculosis at NCTLD in Tbilisi, Georgia indicated as per clinical routine

Exclusion Criteria:

* Non consenting to donate samples and/or data for the study
Impact of Continuous Veno-venous Hemodiafiltration on Efficacy of Administration of Prophylactic Doses of Enoxaparin or Fondaparinux in Critically Ill Patients.

Dose of anticoagulant prophylaxis in patients with continuous veno-venous hemodiafiltration may be insufficient to keep anti-Xa factor activity in prophylactic range.

Coagulation disorders are one of the most common complications in critically ill patients. Among them deep vein thrombosis and pulmonary embolism are the most significant factors increasing morbidity and mortality in ICU patients. Use of anticoagulant prophylaxis aims to prevent these dangerous complications. Most commonly used anticoagulant prophylaxis agents are low molecular weight heparins (LMWH). LMWH therapeutic efficiency is measured with activity of anti-Xa factor, that should range between 0.2 and 0.4 IU/mL in order to prevent thrombotic complications. Due to grave general condition, critically ill patients may often develop acute kidney injury (AKI), that requires renal replacement therapy (RRT). Because of haemodynamic instability the safest therapeutic choice seems to be continuous veno-venous hemodiafiltration (CVVHDF). This RRT mode removes particles in the size of few daltons even up to 10 kilodaltons (kDa) such as metabolic product waste, ions, hormones etc. LMWH with average molecular weight of 4.5 kDa and fondaparinux with average molecular weight of 1.7 kDa may be removed during CVVHDF resulting in insufficient activity of anti-Xa factor thus increasing the risk of thrombotic complications in critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* All adult Intensive Care Unit patients between 18 and 80 years old requiring treatment with CVVHDF;
* Indications for anticoagulant prophylaxis with enoxaparin 40 mg sc. once daily or fondaparinux 2.5 mg sc. once daily;
* Treatment with continuous veno-venous hemodiafiltration.

Exclusion Criteria:

* Indications for low molecular weight heparin use other than anticoagulant prophylaxis;
* Intracranial hemorrhage;
* Incident of serious bleeding within a week before admission to ICU, if not managed;
* Disseminated intravascular coagulopathy;
* Heparin induced thrombocytopenia;
* Hypersensitivity or allergic reaction to enoxaparin or fondaparinux;
* Thrombocytopenia \< 50 G/L;
* Prothrombin time \< 20% or INR (international normalized ratio) \> 1.7;
* Use of antiplatelet drugs;
* Presence of congenital coagulopathy.
Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study

The purpose of the RELIEF study is to compare symptoms in polycythemia vera (PV) subjects treated with ruxolitinib versus subjects treated with hydroxyurea (HU) as measured by the percent of subjects who achieve a clinically meaningful symptom improvement (ie, total symptom score reduction of ≥ 50% reduction) at Week 16 compared to Baseline. The study is also designed to demonstrate that these responses are durable with continued treatment.

This is a Phase 3 multicenter, double-blind, double-dummy, randomized study. Only subjects with PV who have received HU for at least 12 weeks, have been receiving a stable dose before screening, and still have symptoms related to PV will be enrolled.

Subjects will be randomized (1:1) to 1 of 2 treatment arms:

A: ruxolitinib and HU-placebo B: HU and ruxolitinib-placebo

Subjects randomized to either arm may be eligible to transition to open-label ruxolitinib after Week 16.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must currently be reporting symptoms while on a stable dose of HU monotherapy and be eligible to continue HU on study after randomization.
* Before screening, the subject must have been receiving HU for at least 12 weeks AND be receiving a stable dose.
* Subjects must meet baseline symptom criteria
* Subjects should meet at least 1 of the following criteria:

  * No more than 2 phlebotomies within the 6 months before screening OR
  * No palpable splenomegaly.
* Subjects must have a hematocrit that can be controlled within 35% to 48% (inclusive) before randomization.

Exclusion Criteria:

* Subjects with inadequate liver or renal function at screening.
* Subjects with clinically significant infection that requires therapy
* Subjects with known active hepatitis A, B, or C at screening or with known HIV positivity.
* Subjects with an active malignancy over the previous 2 years
* Subjects with clinically significant cardiac disease (Class III or IV).
Spouses/Partners Expressing Their Thoughts After Transplant

This study seeks to test a brief psychological intervention for spousal caregivers of cancer patients (specifically, hematopoietic stem cell transplant patients), persons known to experience emotional distress.

This project focuses on spousal caregivers (CGs) of hematopoietic stem cell transplant survivors - persons known to report elevated levels of distress as compared to both norms and their patient counterparts. Specific Aims are to: (1) Determine, via experimental manipulation, whether or not CGs of hematopoietic stem cell transplant patients engage in protective buffering, a coping mechanism whereby partners shield patients from illness-related concerns or worries, (2) Examine synchrony or lack thereof, desynchrony, among subjective, expressive and biologic indicators of emotion among spousal CGs, and (3) Test the feasibility and implementation of an emotional expression (EE) exercise designed to enhance psychological and immune functioning among spousal CGs.

Eligibility Criteria:
Inclusion Criteria:

* patients and partners at least 21 years of age
* patients and partners English speaking
* patients about to receive a hematopoietic stem cell transplant
* patients married or in a committed, cohabiting, heterosexual or homosexual relationship
* caregivers in a married or committed, cohabiting, heterosexual or homosexual relationship with the patient
* caregivers present at the transplant site and planning to remain so for at least one month

Exclusion Criteria:

* patient major psychiatric disorder
* caregiver presence or history of a neurologic disorder
In-person Versus Online Debriefing in HBB

The objective of this study is to assess the effectiveness of online formative feedback and debriefing on nursing and medical students enrolled in the HBB course in comparison to traditional face-to-face feedback. The working hypothesis is that online feedback and debriefing during hands-on training sessions are as effective as face-to-face feedback and debriefing in teaching clinical skills to medical and nursing students.

Online learning has become an integral part of education, especially during the ongoing COVID19 pandemic that has imposed a limit on live interactions. This observation holds true in the medical education system which uses the flipped classroom model to teach essential practical skills. Studies have shown that this model is associated with improved learning and student satisfaction. In such a model, debriefing and feedback comprise a main part of the teaching process, and these interactions are usually conducted in person. One helpful skill offered to nursing and medical students is Helping Babies Breathe (HBB), which is an evidence-based educational program training first-line birth attendants to initiate effective resuscitation of a newborn in the first minute of life. The investigators propose to incorporate online feedback as part of the HBB course at the American University of Beirut. In this non-inferiority randomized controlled trial, the investigators will study the effectiveness of online formative feedback and debriefing on nursing and medical students enrolled in the HBB course in comparison to traditional face-to-face feedback. The working hypothesis is that internet-based live feedback and debriefing are as effective as face-to-face interactions when teaching clinical skills to nursing and medical students. This work will aid in developing a reliable online curriculum that can be extrapolated to other courses and institutions, thus broadening the reach of medical education in the times of physical distancing.

Eligibility Criteria:
Inclusion Criteria:

* Nurses and medical students

Exclusion Criteria:

* Attended resuscitation course
The Effect of Ivabradine on Patients With Postural Tachycardia Syndrome

The purpose of this study is to determine whether Ivabradine is an effective treatment for postural tachycardia syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with POTS by the following criteria:

  1. The presence of characteristic orthostatic symptoms of the POTS for at least six months.
  2. An increase in the heart rate of at least 30 beats per minute (without concomitant significant decrease in blood pressure of more than 20/10 mmHg) within 10 minutes after assuming a standing position (or during tilt test) on at least 3 separate occasions.
  3. No other concomitant diseases that could explain the symptoms of POTS.

     Exclusion Criteria:

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  1. History of systemic illness capable of affecting of affecting autonomic function (eg, diabetes mellitus, SLE).
  2. History of cardiovascular disease.
  3. History of smoking, drug or alcohol abuse.
  4. Pregnancy, and also uncontrolled thyroid or adrenal disorders.
  5. Using any drug metabolized by cytochrome P450 3A4 enzyme during the last 72 hours.
A Pilot Study to Determine a Candidate Protocol for Transcranial Electrical Stimulation in the Treatment of Anxiety

The investigators examine the efficacy of two different transcranial direct current stimulation (tDCS) stimulation protocols in the treatment of anxiety in an open-label pilot study.

The investigators examine the efficacy of two different transcranial direct current stimulation (tDCS) stimulation protocols in the treatment of anxiety in an open-label pilot study in patients with chronic pain. The investigators also seek to detect autonomic nervous system changes induced by the tDCS, and develop new methods for the measurement of autonomic nervous system functions.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Naïve to tDCS
* Right-handed
* Beck Anxiety Scores \>= 26

Exclusion Criteria:

* Metal implants inside skull or eye
* Severe skin lesions at the electrode placement area
* History of epilepsy or previous seizures
* Pregnant or breast-feeding
* Pacemaker
* History of intracerebral bleeding during the past six months
* Lifetime DSM-IV diagnosis of bipolar mood disorder or psychotic disorder
* DSM-IV diagnosis for substance abuse or dependence during the past six months
Comparison of Thromboembolic Events in Patients Undergoing Thromboprophylactic Treatment With ENOXA® vs Lovenox®

Prospective, monocentric, randomized, parallel group, rater-blinded study using two formulations of Enoxaparin sodium (ENOXA® vs LOVENOX®) to compare the thromboembolic events (symptomatic and asymptomatic) in patients undergoing gastrointestinal cancer surgery and thromboprophylactic treatment with either Enoxaparin formulations.

The study has a secondary focus as to evaluate the immunogenicity of the two formulations of Enoxaparin through a subgroup analysis.

Study followup duration is up to 30 days post surgical procedure.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 years
* Gastrointestinal (GI) Cancer
* Elective or emergency surgery
* Preventive administration of enoxaparin sodium

Exclusion Criteria:

* Patients participating in another study
* Unfractionated heparin (UFH) use up to 30 days prior to surgical procedure
* Renal failure with creatinine clearance \<30 ml / min
* Known history of peripheral venous thrombosis and/or deep venous thrombosis in the 3 months prior to inclusion
* Pregnant or breastfeeding women or women of childbearing age not using medically accepted contraceptive method
* Anticoagulant use in the 3 months prior to inclusion
* Patients with known haemostatic disorder
* Patients not consenting to participate in the study, or not capable of understanding its objectives
Thyroid Gland Dysfunction and Vitamin D Polymorphism in Keratoconus

This prospective study the thyroid gland dysfunction and vitamin D receptor polymorphism in keratoconus patients

This is a prospective observational study in which blood samples are collected from keratoconus patients looking for thyroid dysfunction and vitamin D levels in the serum and assessing the Vitamin D receptor polymorphism in comparison to healthy control.

Eligibility Criteria:
Inclusion Criteria:

* keratoconus patients without previously diagnosed thyroid disorder in comparison to healthy control without known systemic disease and with normal cornea who were selected from candidates of refractive surgery with normal topography

Exclusion Criteria:

* patients who could not provide informed consent or the necessary samples for any reason, patients with associated other ophthalmic pathologies or systemic disorders were excluded from the study
Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke

To evaluate the impact of early ventilation in stroke outcomes in patients with sleep apnea and first ever stroke, 1 month after stroke.

Single-center, randomized, open label, parallel arm, prospective study in patients with sleep apnea after first-ever stroke.

The study will consist of screening, baseline assessment, interventional period (consisting of a treatment period and follow-up visits), and a follow-up phone call.

Patients will be randomly assigned to ASV (active) or control groups, within 4 days after the PSG II and will start the respective intervention in the same day.

Patients assigned to the active group will receive ventilatory support with ASV (DreamStation BiPAP autoSV®) during diurnal and nocturnal sleep, from study randomization until clinically indicated. Patients assigned to control group will receive best medical treatment for stroke alone, including rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained from the participant or the legally acceptable representative, prior to any study-related procedure.
2. Male or female between 18 and 80 years, inclusive, at the time of signing the informed consent.
3. Admission to the hospital within 48 h of stroke symptoms onset.
4. Ischemic first stroke diagnosis.
5. NIHSS ≥2 at screening.
6. Sleep apnea with AHI ≥15.

Exclusion Criteria:

1. CSA with Left Ventricular Ejection Fraction ⩽45%.
2. Ventilation treatment for sleep apnea diagnosis, prior to stroke.
3. Risk of aspiration.
4. Nasogastric feeding tube.
5. Transient ischemic attack, hemorrhagic stroke or subarachnoid hemorrhage.
6. Stroke due to a secondary cause (e.g. vascular malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding).
7. Cardiorespiratory distress.
8. Advanced chronic lung disease requiring supplemental oxygen.
9. Concomitant central nervous system diseases such as dementia or multiple sclerosis.
10. Uncontrolled psychosis or agitation.
11. Glasgow Coma Scale (GCS) score \<10 at screening.
12. Anosognosia, global or Wernicke aphasia.
13. Insufficient upper limbs function to use a mask and no overnight caregiver to help.
14. Inability to attend to the rehabilitation program of the hospital.
15. Pregnant and breast-feeding women.
16. Participation in another clinical study (except a standard-of-care registry).
17. Any other condition that, according to the Investigator, renders the subject unsuitable for ventilation.
Impact of the Use of Zinc in the Prevention of Oral Mucositis in Pediatric Patients With Lymphoblastic Acute Leukemia.

Oral mucositis (OM) is a secondary complication of chemo/radiotherapy, which causes pain, dysphagia and predisposition to infections, being a frequent reason for hospitalization that may have an impact on the prognosis of cancer patients. Various interventions for the prevention of OM have been studied, including the use of zinc, which is a micronutrient that participates in various cellular functions and in wound repair, while showing a reduction in the incidence and severity of MO, so the purpose of the present study is to evaluate the impact of the use of zinc in the prevention of oropharyngeal mucositis in pediatric patients with acute lymphoblastic leukemia in chemotherapy, comparing it with the use of placebo.

Hypothesis: The use of zinc reduces the incidence and severity of OM in pediatric patients with ALL in chemotherapy compared to the control group.

Objective: To evaluate the impact of the use of zinc in the prevention, incidence and severity of oral mucositis in patients with acute lymphoblastic leukemia in chemotherapy (induction and consolidation phase) of the National Institute of Pediatrics and the Federico Gómez Children's Hospital of Mexico during the period from 2019 to 2020.

Methodology: Double-blind randomized clinical trial conducted in pediatric patients with newly diagnosed or relapsed acute lymphoblastic leukemia. The subjects will be randomized to designate them in the control group (Group1 placebo) or intervention group (Group 2 zinc). The zinc / placebo intervention will be administered orally in tablets of 50-100 mg / day, from day 1 of chemotherapy until the end of the consolidation phase (2 to 2.5 months). For the detection of OM the mucositis scale of the World Health Organization will be used and the observation times will correspond to day 1, 4, 7, 14 and 21 of each chemotherapy cycle. Patients of both groups with OM will receive the same treatment (mouthwash of Gelclair) and will be observed daily until healing to determine the days of recovery.

Statistical analysis: Independent t-test and Chi-square test for the difference between the two study groups, ANOVA to compare the groups with respect to the severity of OM.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 3 to 18 years
* Patients with recent diagnosis of ALL or relapse
* Pacientes who accept by informed consent to participate in the study.

Exclusion Criteria:

* Patients with another disease or systemic condition in addition to ALL.
* Patients with Down syndrome
* Patients allergic to zinc or mannitol.
Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Chronic Phase Who Are Refractory to Imatinib Mesylate (Gleevec)

To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia chronic phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.


Eligibility Criteria:
Inclusion:

* Histologically confirmed diagnosis of CML chronic phase
* Ph chromosome-positive
* Previous treatment with imatinib mesylate resulting in: i) Hematologic Resistance / Hematologic Refractory: Based on a physician's (documented) decision to discontinue imatinib mesylate treatment due to failure of continued benefit or no benefit to the patient, ii) Imatinib Mesylate Intolerance: any toxicity resulting in a physician's (documented) decision to discontinue imatinib mesylate treatment.
* Patients must have recovered from the side effects of previous CML therapy for chronic phase with the exception of hydroxyurea
* Age \>/= 2 years
* Bilirubin \</= 3 x the upper limit of normal (ULN), SGOT and SGPT \</= 3 x ULN, except \</= 5 x ULN in leukemic involvement of the liver, serum creatinine \</= 2 x ULN
* WHO performance status 0-3
* A negative serum hCG pregnancy test in patients of childbearing potential
* Able to give signed informed consent directly or through a parent or guardian for minors

Exclusion:

* Leukemic involvement of the central nervous system
* Active malignancy other than CML or non-melanoma cancer of the skin
* Previous treatment for CML with another investigational agent within 28 days of study entry
* At study entry, patients who were treated with: imatinib mesylate within the past 48 hours; interferon-alpha within the past 48 hours; homoharringtonine within the past 14 days; low-dose cytosine arabinoside within 7 days, moderate dose within 14 days, or high dose within 28 days; etoposide, anthracyclines, or mitoxantrone within 21 days; busulfan within the past six weeks
* Patients who had received hematopoietic stem cell transplantation within 6 weeks of Day 1 decitabine therapy
* Patients with Grade 3/4 cardiac disease or any other serious concurrent medical condition.
* Patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study.
* Patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements
* Patients with systemic, uncontrolled infections