cyrilzakka/clinical-trials huggingface dataset:
Comparison of N-butyl-cyanoacrylate and Micro Parti-cles Effect in Inducing Liver Hypertrophy After PVE

The aim of this study is to compare hypertrophy of the FLR after PVE with microparticles to hypertrophy after PVE with cyanoacrylate in a material large enough to answer the study question. In addition, other factors that may influence the degree of hypertrophy will be evaluated in a multivariable analysis.

The hypothesis is: PVE with cyanoacrylate is superior to PVE with microparticles in terms of FLR hy-pertrophy.

With expansion of indications for major liver surgery, portal vein embolization (PVE) is increasingly used in order to induce hypertrophy of the future liver remnant (FLR). De-spite vide variety of materials available to occlude the portal veins the most commonly used are cyanoacrylate and microparticles/spheres. Earlier studies have failed to show superiority of one over the other in terms of hypertrophy of the FLR while PVE with cy-anoacrylate seems to be less time consuming. Two small previous studies from single centers have shown greater growth by cyanoacrylate compared to particles (1) with 90 included patients and the second study with 34 included patients (2), but larger reviews have failed (3). Cyanoacrylate might give a more robust FLR hypertrophy (4) . The main problem in evaluating previous studies has been the large heterogeneity and the often poorly described study populations.

Eligibility Criteria:
Inclusion Criteria: Over 18 years old. Planned for portal vein embolization. -

Exclusion Criteria:

-
Anxiety Level and Oral Hygiene Practice in Dental Students During Covid-19 Pandemic

Covid-19, the infection caused by a novel corona virus detected in December 2019 in Wuhan (Hubei province), is now a pandemic announced by World Health Organization, raising concerns of widespread panic and increasing anxiety in individuals. This outbreak results in mass quarantine in Egypt since middle of March 2020. Brooks et al. (2019) reviewed and reported quarantine could bring "post traumatic stress symptoms, confusion, and anger. Stressors included longer quarantine duration, infection fears, frustration, boredom, inadequate supplies, inadequate information, financial loss, and stigma.". Many universities decided to suspend in-person classes and evacuate students in responding to the intensifying concerns surrounding Covid-19. This action can lead to negative psychological consequences among college students. Oral health related behavior and attitudes habits correlate with oral health status and can be considered to be its predictors . There is a claim of potential connection between high bacterial load in the mouth and complications associated with Covid-19 infection. Bacteria present in the meta genome of patients severely infected with Covid-19 included high reads for Prevotella, Staphylococcus, and Fusobacterium, all usually commensal organisms of the mouth. Over 80% of patients in ICU exhibited an exceptionally high bacterial load. Accordingly, the investigators assume that good oral hygiene better to be maintained during a Covid-19 outbreak in order to reduce the bacterial load in the mouth and the risk of a bacterial super infection in case of catching the infection .

While there seems to be a common belief that psychosocial stress affects oral hygiene behavior, this assumption has rarely been proved9 Dental students, as the future providers of dental care, are ex¬pected to be role models for their patients regarding the oral hygiene practice and they supposed to be aware of the importance of preserving the oral health. Thus, we intended to select them as our population to study how the level of anxiety during pandemic could affect the practice of oral hygien

A cross sectional study (survey) will be conducted among dental students in faculty of dentistry Cairo University for the duration of one month from June 2020 to July 2020.

The questionnaire has three parts. The first part included demographic details. The second part included validated general anxiety disorder scale GAD-7. Questionnaire consisting of seven questions which measures students' anxiety level score. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. The third part the validated self administered, structured, and close ended 15 questions that assessed the self reported oral hygiene practices 11. The questionnaire forms were kept anonymous. The questionnaire was validated.

Eligibility Criteria:
Inclusion Criteria:

* Student of faculty of Dentistry, Cairo University

Exclusion Criteria:

-
Effect of Stress Ball on Perceived Stress, Pain and Satisfaction in Cancer Patients

The objective of this study was to ascertain the impact of stress ball utilisation on perceived stress, pain and satisfaction levels during port catheter intervention in cancer patients. In this study, which was conducted in a randomised controlled design, a control group of cancer patients receiving chemotherapy (n=37) was assigned to receive standard care during port catheter needle insertion. An intervention group (n=37) was also formed, comprising patients who received stress ball application in addition to standard care. The intervention group was provided with a stress ball in both hands five minutes prior to the insertion of the port catheter needle and instructed to squeeze the ball in their hands at regular intervals until the conclusion of the procedure. Prior to the application, the descriptive characteristics of both groups were ascertained, and their perceived stress levels were assessed. Subsequently, the pain and perceived stress levels of both groups were documented. Additionally, the satisfaction levels of the intervention group regarding the stress ball application were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Diagnosed with cancer
* Undergoing active chemotherapy
* Willing to participate in the research .

Exclusion Criteria:

* Communication difficulties
* Complaints of peripheral neuropathy
* Refusal to participate in the research
Evaluation of SVV From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery

NICOM® is a recently developed noninvasive cardiac output monitoring device, and indices derived from NICOM® such as SVV has been reported to predict fluid responsiveness in the previous studies. However, its usefulness in prone positioning has not been investigated. Thus, the aim of this prospective observational study is to evaluate the usefulness of stroke volume variation (SVV) derived from NICOM® to predict fluid responsiveness in prone patients undergoing spine surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA I or II patients undergoing spine surgery in prone position

Exclusion Criteria:

* Pre-existing arrhythmic disorders/moderate to severe valvular heart disease/obstructive pulmonary disease (COPD grade \>2), left ventricular dysfunction with LV EF less than 50, preoperative need for inotropics or vasopressors
* BMI \>30kg/m\^2 or \<15kg/m\^2
* Preoperative serum Cr \> 1.3mg/dL
* Patients with coagulopathy
A Prospective Study of the NUVANCE Facial Rejuvenation System for Mid-Face, Neck and Jowl Rejuvenation Procedures

The objective of this study is to evaluate the clinical tolerability of the NUVANCE™ Facial Rejuvenation System for correcting neck, mid-face and/or jowl ptosis.

This is a multicenter, prospective, single-arm study. The primary tolerability endpoint will be evaluated up to 30-days post-operatively. Secondary endpoints will be evaluated at 6-months. Extended follow-up will be conducted at 12-months, 24-months, and 36-months.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject older than 18 years.
* Subject is a candidate for minimally invasive, bilateral facial rejuvenation procedure using NUVANCETM Facial Rejuvenation System according to the device Instructions for Use (IFU).
* Subject is willing and able to provide informed consent and follow study-related requirements.

Exclusion Criteria:

* Subject who previously received surgical facial cosmetic treatment (procedure involving an incision):

  1. Within the last 12 months under the area of the forehead;
  2. Within the last 3 months within the area of the forehead where forehead is defined as the area above the imaginary anatomical line between the lateral canthus of the eye and the upper pole of the ear.
* Subject who previously received a cosmetic procedure with a dermal filler device and/or neurotoxin complex injectable within the last 9 months.
* Subjects with a permanent facial implant.
* Subjects planning on a cosmetic procedure with a permanent implant within 6-months of procedure.
* Subjects planning on a cosmetic procedure with a dermal filler device and/or neurotoxin complex injectable within 6-months of procedure.
* Subjects with significant ptosis where skin excision would be necessary.
* Subject has an active infection (e.g. acne, herpes zoster) or inflammation (e.g. psoriasis, pemphigus vulgaris, cutaneous lupus erythematosus) affecting facial skin.
* Subject has a history of a disorder that can affect wound healing (e.g. subjects pre-disposed to infection or history of keloid formation).
* Subject with pre-existing facial abnormalities (e.g. deformities, Bell's palsy, scarring)
* Subject with a significant psychiatric disorder judged by the clinical investigator that will interfere with the procedure
* Any pre-operative findings that the surgeon identifies that makes the subject not a candidate for a minimally invasive facial cosmetic surgical procedure.
Enalapril After Anthracycline Cardiotoxicity

To determine if the chronic administration of enalapril, an inhibitor of angiotensin converting enzyme (ACE), reduces progression of cardiac dysfunction in pediatric oncology patients who have received anthracyclines, and who are not currently on digoxin, diuretics, or vasodilators for heart failure.

BACKGROUND:

Pediatric oncology patients who have been treated with anthracycline therapy as a part of their chemotherapeutic regimen often subsequently develop left ventricular failure. The optimal medical management is not known. This trial will be the first to provide comprehensive data on a well characterized population regarding the role of afterload reduction using enalapril to treat ventricular dysfunction after anthracycline chemotherapy

DESIGN NARRATIVE:

Randomized, double-blind. Randomization was stratified by total anthracycline dose, follow-up time from treatment, and age at time of treatment. All patients received the following baseline tests: Maximal Cardiac Index (MCI) on cycle ergometry; echocardiogram/Doppler determined left ventricular end systolic wall stress (ESWS); gated nuclear angiography (GNA) to determine left ventricular ejection fraction; Holter monitoring for 24 hour ECG monitoring. Patients were randomized to either enalapril or placebo. Follow-up visits were conducted to ensure compliance and screen for side effects. MCI and ESWS were measured twice yearly, while all four tests were repeated at the conclusion of the trial, after four to five years of treatment. The primary outcome variables were the rate of decline in MCI and the rate of increase in ESWS. Secondary outcomes were the change in left ventricular ejection fraction and the incidence of arrhythmias. A second aim of the study was to develop an algorithm to determine indications for enalapril use if the study succeeded in showing a treatment effect. This required modeling the probability of cardiac dysfunction given patient characteristics at treatment, treatment type, cardiac status during treatment and at follow-up, and the development of cost effectiveness and medical decision making models testing the proposed algorithm.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Eligibility Criteria:
Boy and girl pediatric oncology patients, at least two years off treatment, with some cardiac dysfunction, but not congestive heart failure, after receiving anthracyclines. Patients were not on digoxin, diuretics, or vasodilators for heart failure.
NAD Therapy for Improving Memory and Brain Blood Flow in Older Adults With Mild Cognitive Impairment

This study will provide insight into whether a nutritional supplement, nicotinamide riboside (NR), improves memory and brain blood flow in older adults with low memory abilities. Overall, this project has the potential to identify a novel, safe and cost-effective strategy for decreasing age-related memory loss.


Eligibility Criteria:
Inclusion Criteria

* Cognitive function scores consistent with amnestic mild cognitive impairment based on pre-screening evaluation;
* age 60-90 years;
* MMSE score \>24 at time of initial consent;

Exclusion Criteria

* blood chemistries indicative of abnormal renal, liver, thyroid and adrenal function; estimated glomerular filtration rate using the MDRD prediction equation must be \>30 ml/min/1.73 m2;
* any clinically significant abnormal blood chemistry values as determined by the research nurse or NMPCC nurse practitioner;
* major psychiatric disorder (e.g. schizophrenia, bipolar disorder, major depression within past two years);
* neurological or autoimmune conditions affecting cognition (e.g. Parkinson's disease, epilepsy, multiple sclerosis, mild or severe traumatic brain injury, large vessel infarct);
* concussion within last 2 years and ≥ 3 lifetime concussions;
* current systemic medical illnesses (e.g. cardiovascular disease, cancer, renal failure);
* prior history of any type of cancer;
* substance abuse or dependence (DSM-V criteria);
* current use of medications used to treat dementia (e.g., anticholinesterase drugs) or other drugs likely to affect cognition (e.g., anticholinergic drugs, long-acting benzodiazepines);
* claustrophobia, metal implants, pacemaker or other factors affecting feasibility and/or safety of MRI scanning\*;
* current smoking (including marijuana) within the past 3 months;
* hospitalization as a result of COVID-19
BeFluBu vs FluBuRux Conditioning in Haploidentical HCT

Haploidentical hematopoietic stem cell transplantation irrespective of the conditioning intensity and graft-versus-host disease prophylaxis is associated with high frequency of primary and secondary graft failure. Different technologies of with replete or depleted graft are associated with 7-20% of graft failures in different diseases. Fludarabine and busulfan conditioning is the most commonly used approach for a variety of diseases. In two previously completed trials of addition of either bendamustine and ruxolitinib to conditioning we observed low rates of primary graft failure with both approaches. The study is the direct randomized comparisons of these two approaches with the primary aim of reducing composite events of primary graft failure, relapse and non-relapse mortality. The stratas for the study are Disease Risk Index (DRI) and the age of the haploidentical donor (\<35 vs ≥35).


Eligibility Criteria:
Inclusion Criteria:

* Patients must have an indication for allogeneic hematopoietic stem cell transplantation with myeloablative conditioning for malignant disease
* Diagnosis: acute myeloid leukemia, acute lymphoblastic leukemia, mixed lineage acute leukemia, lymphoblastic lymphoma, chronic myeloid leukemia, myelodysplastic syndromes, myeloprolipherative neoplasm
* Age ≥18
* Malignant disease in hematologic response: \<5% of clonal blasts in the bone marrow and no clonal blasts in peripheral blood.
* Patients with 5-9/10 HLA-matched related donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.
* Peripheral blood stem cells or bone marrow as a graft source

Exclusion Criteria:

* Titer of anti-donor anti-HLA antibodies ≥ 5000 at the time of inclusion
* Moderate or severe cardiac disease: ejection fraction \<50%, unstable angina, stable angina NYHA class III or IV, chronic heart failure NYHA class III or IV, Lawn grade V arrhythmia, myocardial infarction within 3 months before inclusion
* Stroke within 3 months of inclusion, unless related to the underlying malignancy
* Severe decrease in pulmonary function: FEV1 \<50% or DLCO\<50% of predicted or respiratory distress or need for oxygen support;
* Severe organ dysfunction: AST or ALT \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits
* Creatinine clearance \< 40 mL/min
* Uncontrolled bacterial or fungal infection at the time of enrollment defined by CRP\> 70 mg/L
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index \<70%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent
Prevention of Postoperative Bleeding in Subcapital Femoral Fractures

The main hypothesis of this clinical trial is that the use of intra-articular tranexamic acid and the fibrin glue plus usual hemostasis will reduce at least a 25% the postoperative blood loss with respect to usual hemostasis in patients undergoing subcapital femoral fractures.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Patients with unilateral subcapital femoral fracture
* Patients requiring hip replacement (total or partial)
* Signed informed consent from the patient or legal representative

Exclusion Criteria:

* Known allergy to fibrin glue and tranexamic acid
* Multiple fractures
* Pathological fractures
* Contraceptives or estrogen therapy
* Use of blood salvage during surgery
* History compatible with thromboembolic disease:

  * Cerebral vascular accident
  * Ischemic heart disease (myocardial infarction, angina )
  * Deep vein thrombosis
  * Pulmonary Embolism
  * Peripheral arterial vasculopathy
  * Patients with thrombogenic arrhythmias
  * Patients with cardiovascular stents
  * Prothrombotic alterations in coagulation
Follow Up of Gestational Carriers and Intended Parents

To explore the attitudes and reactions of gestational carriers and intended parents though their medical, pregnancy and postpartum experiences.

This study will first evaluate whether there is any existing psychopathology in gestational carriers prior to their pregnancies. Second, the study will explore the gestational carriers' and intended parents' experiences including attachment with quantitative measurements. These measurements will be collected prospectively.

Eligibility Criteria:
None, other than being either a gestational carrier or intended parent.
Parasitic Infection in Anemic Pregnant Women

Women included between 18 and 45 years old, pregnant during their second or third trimester of pregnancy (calculated by a sure menstrual date and confirmed by a 1st trimesteric ultrasound) with hemoglobin level below 10.5 mg /dL.

All patients in the study were subjected to:

1. Detailed history was recorded. A proper history concerning age, sex, residence, socioeconomic status, onset, progression, and previous treatment of anemia was taken. Participants' socio-demographic characteristics including gravida and parity were documented, level of education, occupation, Diet, and information useful to determine the socioeconomic level was recorded. Information on previous pregnancies and children and history of chronic diseases were also recorded.
2. General examination; patients were clinically examined and gestational age (assessed by measuring the fundal height), weight was calculated for each participant.
3. Diagnosis of anemia by Complete blood count (CBC), Hb level and measuring hematocrit concentration.
4. Diagnosis of parasitic infection by stool analysis using suitable techniques.
5. Imaging including obstetric ultrasound (U/S) to assess fetal development.
6. Women with helminthic infections will be divided into groups

Group (A): received iron + antiparasitic treatment as follows:

* Patients who have STH received alzental 200mg tab 2 tabs single oral dose.
* Patients who have Entamoeba or Giardia received flagyl 500mg tab twice daily for 5 days.
* (B): received iron only.

Eligibility Criteria:
Inclusion Criteria:

* pregnant during their second or third trimester of pregnancy (calculated by a sure menstrual date and confirmed by a 1st trimesteric ultrasound)
* hemoglobin level below 10.5 mg /dL

Exclusion Criteria:

* women with chronic diseases as diabetes, heart, renal, hepatic or endocrinological disorders
* women diagnosed with blood diseases as hemoglobinopathy or vascular diseases as vasculitis.
* Women with autoimmune diseases and those allergic to iron or antihelminsic treatment were also excluded
Study Comparing Radiation Therapy and Chemotherapy with or Without Nimotuzumab

Primary: to compare the overall survival defined as the time elapsed between the randomization date and death due to any cause, in both treatment groups.

Secondary: to compare the progression-free survival, incidence of locoregional failure, site of the first recurrence/progression, objective response rate assessment, quality of life assessment and incidence of adverse events.

This is a phase III, superiority, national, open-label, randomized, and two-arm study.

Patients' enrollment will be performed only after approval by competent regulatory authorities and it will last up to 12 months.

All patients taking part in the study must sign an informed consent. The patients will have stage III or IV, unresectable head and neck SCC, performance status 0 or 1.

Randomization and treatment assignment will be performed by a company specifically contracted for such purpose and will be per research site and disease stage, 1:1

Eligibility Criteria:
Inclusion Criteria

* Aged 18 to 75 years old;
* Histological or cytological confirmation of SCC in oral cavity, oropharynx, hypopharynx, or larynx;
* Stages III or IV disease
* Unresectability according to responsible surgeon or medical staff's opinion;
* Performance status 0 or 1
* Present indication for radiation therapy and chemotherapy treatment with cisplatin;
* Adequate hepatic, renal and medullar functions, indicated by:
* Life expectancy above 6 months.

Exclusion Criteria

* Presence of nasopharyngeal, paranasal sinuses, or salivary glands carcinoma;
* Presence of known distant metastasis;
* Presence of any other active neoplasm or history of any tumor diagnosed in the last 5 years
* Patients with inability to eat normally, in whom a gastric or enteral tubing was not possible at least 2 weeks before their enrollment in the study;
* Previous treatment with chemotherapy, radiation therapy, or EGFR inhibitors of any pharmacological class;
* Presence of serious comorbidity that, in the investigator's opinion, will put the patient at risk or will jeopardize protocol compliance;
* Active known seropositivity for HIV, hepatitis B or C
* Presence of a significant neurological or psychiatric disease, as per the investigator's judgment;
* Hypersensitivity or allergy to any of the study treatments;
* Presence of uncontrolled hypercalcemia;
* Pregnancy or breastfeeding;
* Female patients of childbearing potential who wish to become pregnant or are unwilling, as well as their partners, to use an appropriate contraceptive method throughout the study period;
* Participation in any clinical trial in the last 12 months.