cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Efficacy and Safety of the Prophylactic Use of PEG-rhG-CSF in Children With Hematological Malignancies

The incidence of infectious complications in hematological malignancies is higher than that in children with solid tumors, which may be related to the type and dose intensity of chemotherapy regimens used in hematological tumors. The treatment of childhood cancer has changed in the past few decades: intensive treatment and good supportive treatment can improve the 5-year survival rate of children. The aim of this study was to evaluate the efficacy and safety of prophylactic use of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) after chemotherapy in children with hematological malignancies.


Eligibility Criteria:
Inclusion Criteria:

1. Under the age of 18, no gender limit;
2. Children with hematological malignancies, leukemia or lymphoma, diagnosed by bone marrow pathology or cytology;
3. The prophylactic use of PEG-rhG-CSF or rhG-CSF after chemotherapy is intended to prevent neutropenia, and the chemotherapy regimen must meet the interval between two chemotherapy sessions at least 12 days;
4. The effect of chemotherapy in leukemia patients was complete remission, while that in lymphoma patients was complete remission or partial remission;
5. The expected survival time is more than 8 months;
6. Liver and kidney function: Liver function: total bilirubin (TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal value, or≤5 times the upper limit of normal value when there is liver metastasis; renal function test: serum creatinine (Cr) ≤ 1.5 times the upper limit of normal value;
7. Eastern Cooperative Oncology Group(ECOG) performance status(PS) \<2;
8. The subjects had good mental consciousness, and the subject's legal guardian must sign an informed consent form;
9. Researchers believe that the subject can benefit;

Exclusion Criteria:

1. Severe internal organ dysfunction;
2. Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollment;
3. Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
4. Researchers determine unsuited to participate in this trial.
Aspirin as an Ultraviolet (UV) Protectant in Human Subjects at Risk for Melanoma

This is a phase II placebo-controlled intervention trial assessing aspirin (ASA) as a UV protectant in patients at risk for melanoma.

While melanoma risk is largely genetically determined, exposure to ultraviolet (UV) radiation in sunlight is the major environmental risk factor. Although sunscreen use can reduce melanoma risk 2-fold, its efficacy has been questioned, and most patients do not apply sunscreens properly.

This study will evaluate the downstream effects of aspirin (ASA) in human blood and skin moles (nevi) following oral ingestion. We will determine if chronic ingestion of ASA can modulate UV-sensitivity of the skin, UV-induced damage in nevi, and PGE2 levels in blood and nevi.

Eligibility Criteria:
Inclusion Criteria:

* Must have at least 2 nevi (each \>5 mm diameter) not clinically suspicious for melanoma that can be biopsied.
* Must be older than age 18.
* Must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

* The patient cannot speak / understand English or Spanish.
* The patient is pregnant or breastfeeding.
* The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable.
* The patient has history of allergic reaction to ASA.
* The patient has history of severe asthma.
* The patient has been taking ASA or any NSAID in the past 2 weeks.
* The patient has been taking a blood thinner in the past 2 weeks.
* The patient has history of bleeding disorder.
* The patient has history of peptic ulcer disease.
* The patient has had recent intense UV exposure in the past month.
Influence of CT 3D on the Learning Curve of Laparoscopic Colorectal Resection

Laparoscopic colorectal surgery has been widely accepted worldwide; however, despite the well-known benefits and comparable oncological outcomes, it is still limited by a lack of tactile sensation and a reduced operative field view. In addition, the inconsistency in the number and course of the mesenteric vessels significantly influences the learning curve with 30 to 70 cases required for proficiency. To overcome these limitations, the vascular anatomy can be mapped using CT-angiography, and the images can be processed with rendering software to reconstruct a three-dimensional model of the mesenteric vessels. The aim of this study was to assess the influence of visualizing the three-dimensional vascular anatomy on the learning curve for laparoscopic colorectal surgery.All patients who underwent laparoscopic left or right hemicolectomies between January 2012 and January 2014 were evaluated for inclusion in this study. To assess the influence of preliminary knowledge of colonic vascular anatomy on the learning curve, we considered 2 groups of two surgeons with different levels of experience. In the first group (group A), the surgeons were able to view 3D reconstructions before and during the surgery, while the surgeons in Group B were only able to view the 3D reconstructions after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients in which standard laparoscopic right or left hemicolectomy was planned

Exclusion Criteria:

* patients who underwent extended right hemicolectomy and segmental colectomy or sigmoidectomy and patients for whom the surgical technique was modified intraoperatively
* patients who underwent anterior rectal resection and emergency procedures for complicated diverticulitis were excluded because these procedures require higher technical skills.
* Patients who had an ASA score of IV, a BMI over 40 or contraindications for laparoscopy were also excluded.
[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial

This protocol is a companion imaging study that will add FES-PET/CT imaging to the FORESEE trial at HCI. This study will establish the feasibility of using FES-PET/CT imaging to guide therapeutic decision making for functional precision oncology trials. The unique ability of FES-PET/CT to show absence of functional estrogen receptors throughout the entire body may improve confidence among research oncologists that an ER+ metastatic breast cancer patient is truly refractory to hormonal therapies which is a critical determination in the study design of the FORESEE trial.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or greater.
* All patients or legal guardians are willing and able to sign written informed consent and HIPAA authorization in accordance with local and institutional guidelines.
* Enrolled on the FORESEE trial.
* Biopsy proven estrogen receptor positive breast cancer.
* Patient deemed refractory to all combinations of hormonal therapies by FORESEE trial investigators.

Exclusion Criteria:

* Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
* Patients who require monitored anesthesia for PET/CT scanning.
* Patients who are too claustrophobic to undergo PET/CT scanning.
* Patients who are pregnant or currently breast feeding.
* Any patient that is medically unstable defined as a patient requiring inpatient hospitalization or needing evaluation at an acute care or urgent care facility at the time of imaging.
Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or m

The primary objective of the study is to collect epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity and to correlate EGFR mutation status with clinico-pathological characteristics (e.g. smoking status, sex, histology, etc). In particular, the study will aim to determine the frequency of EGFR M+ lung cancers in patients with clinico-pathological characteristics that are not commonly associated with EGFR mutation positivity (i.e., smokers, men, and non-adenocarcinoma).

An NIS Registry for the Epidemiological and Scientific evaluation of EGFR mutation status in patients with newly diagnosed locally advanced or metastatic NSCLC (stage IIIB/IV non-small cell lung cancer)

Eligibility Criteria:
Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV). Mixed histology of small cell and non-small cell lung cancer
Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid

The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal Spray for the treatment of seasonal allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide consent/assent
* History of spring/summer allergic rhinitis
* Positive skin prick and/or intradermal test
* Absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations
* Non-pregnant (where applicable)
* Able to complete daily diary

Exclusion Criteria:

* Smoker
* Concurrent disease such as rhinitis medicamentosa or large obstructive nasal polyps
* History of current chronic sinusitis
* Asthma
* Use of anti-allergy immunotherapy, corticosteroids, chronic use of long acting antihistamines
* History of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses
* History or evidence of nasolacrimal drainage system malfunction
Efficacy of Escitalopram in the Treatment of Internet Addiction

The purpose of this study was to determine whether Lexapro (Escitalopram) is safe and effective in treating problematic internet use.

Many individuals experience marked distress and functional impairments as a result of their perceived inability to control their 'non-essential' (non-job/school related) use of the Internet. Frequently these people develop a preoccupation with the Internet, a need for escape to the Internet, and increasing irritability when trying to cut back use of the Internet. There have been no studies to date looking at the effectiveness of medications in the treatment of this disorder. In our clinical experience, we find these patients with Internet addiction usually respond to serotonin reuptake inhibitors within 12 weeks. This study will examine the efficacy of escitalopram in Internet addiction among adults.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has signed an informed consent form
2. Current diagnosis of Internet addiction
3. Age ³ 18
4. Subject must be able to take oral medication
5. Subject may be in psychotherapy initiated at least three months prior to Screening. Subject must not discontinue or otherwise alter this therapy during the study.
6. In the opinion of the investigator, the subject is capable of complying with all study procedures.

Exclusion Criteria:

1. Current suicidal or homicidal ideation
2. Subject has a primary diagnosis of schizophrenia or other psychotic disorders
3. Subject has a primary diagnosis of Bipolar I disorder
4. Current pedophilia
5. Current DSM-IV diagnosis of substance dependence or abuse, excluding nicotine
6. Women of child-bearing potential who are pregnant, nursing, or not using contraception
7. Use of antidepressants at a therapeutic level for the treatment of problematic internet use within 2 weeks prior to study entry (or 4 weeks for use of MAOIs, or 6 weeks for use of fluoxetine)
8. Current use of antidepressants at a therapeutic level for the treatment of a disorder other than problematic internet use
9. Subject has any organic mental disorder
10. Clinically significant unstable medical disorder
Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder

The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive Disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18 and 65 years of age, with a diagnosis of a single or recurrent, non-psychotic episode of major depressive disorder, as defined by DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) which is equal to or greater than 8 weeks in duration.
* Subjects must currently be taking allowable antidepressant therapy at an adequate dose for a minimum of six weeks by the end of the screening period (ie at the time of the Baseline visit).
* Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than four adequate antidepressant treatments.

Exclusion Criteria:

* Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug.
* Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration.
* Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia,amnestic or other cognitive disorder Schizophrenia, schizoaffective disorder, or other psychotic disorder Bipolar I or II disorder, eating disorder (including anorexia nervosa or bulimia), obsessive compulsive disorder, panic disorder, post-traumatic stress disorder.
* Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
The Emergency Department Falls Study

This is a pilot study to evaluate clinical predictors of intracranial bleeding in elderly patients who present to the emergency department (ED) after a fall. The aim is to assess feasibility and rate of patient recruitment, patient follow up, and to establish a point estimate for the incidence of intracranial bleeding in the investigator's population.

Currently there are no guidelines for ED physicians to assess the pretest probability of intracranial bleed in these patients, and no safe way to exclude a bleed without CT.

Seniors account for 15% of the Canadian population. The proportion will greatly increase over the next few years. Elderly people attend the ED more often than younger people, and they often come to the ED after a fall at home or outside. Falling is associated with head injuries, which cause half of all the deaths from falling.

Head injuries are diagnosed with CT scans. In the ED, it can be difficult for the physician to know when to perform a CT scan of the head. It can be hard to know if the elderly person hit their head, and often times, people with bleeding in the head can have a normal examination. The Investigators think that the overall risk of bleeding in the head in elderly who fall is between 3 and 10%. If emergency physicians scanned every senior who fell, only a few would show bleeding, the scanning department would be overwhelmed, there would be increased costs for the hospital and longer delays for patients. It is important for physicians to diagnose a serious head injury as there are lifesaving treatments that can be given.

The Investigators plan to develop a decision rule for emergency physicians that would inform them which patients should have a CT scan of the head and which patients can have a serious head injury safely ruled out without a CT.

The Investigators propose to identify and recruit patients over the age of 65 who come to the Hamilton General or Juravinski Emergency departments after falling. Patients and their caregivers will be consented for a telephone follow-up call after 6 weeks. Data collected will include patient characteristics, general health, and blood test results which might be predictors of a serious head injury.

The Investigators will develop a tool to help emergency physicians to order a CT scan on the right patients.

Eligibility Criteria:
Inclusion Criteria:

* 65+ years
* Presenting to the emergency department with fall on level ground, from a bed, from a chair, from the toilet seat or down steps 1 or 2 steps, within the last 48 hours

Exclusion Criteria:

* Non-English speaking without an an adequate interpreter
* Falls with an other mechanism of injury
* Falls \> 48 hours before presentation
Effectiveness of TU and MRT to Release Trigger Points to Increase RoM and Pain Relief in Upper TT

To find out the Effectiveness of Therapeutic Ultrasound and Myofascial Release Technique to Release Trigger Points to Increase Range of Motion and Pain Relief in Upper Trapezius Tightness


Eligibility Criteria:
Inclusion Criteria:

* 1. Age between 20-40years.
* 2. Male and female both are included.
* 3. Those having tenderness on a taut muscle band, rise in regular pain, local twitching response, and restricted range of motion of cervical region.

Exclusion Criteria:

* 1. Those having referred pain due to any pathology of cervical.
* 2. Those having any healing fractures over upper back and in neck region.
* 3. Those who have dermatitis over upper back or any clotting disorder.
* 4. Any related wound in neck region or any pathology of shoulder.
* 5. Those who has any degenerative cervical spine disease. (2)
Medico-ecological Monitoring ((CSM, MCTQ, SPAQ, PSQI, HRV, Spirometry; Anthropometry, BP) of the Different Population Groups (Students, Schoolchildren, Volunteers) in North Caucasus

Observational Clinical Trial of the chronotype, sleep quality, seasonal pattern, behavioral time preferences, the functional state of the body's regulatory systems and respiratory systems in individuals of different age groups and metabolic status. In the process of medico-ecological monitoring, including all of the above, an assessment of the psycho-physiological status and the state of the regulatory and respiratory systems of the subjects' body, living in North Ossetia-Alania, will be made.

Modern methods of medicine are aimed at maintaining homeostasis in a situation when, under the influence of factors of the external or internal environment, acute, chronical and extreme (in Covid-19 isolation) physiological stress, is formed, which the body is no longer able to compensate, and which forms the main group of human diseases - adaptation diseases, primarily cardiovascular, including cardiometabolic syndrome. Against the background of the Covid-19 pandemic, in conditions of limited physical activity, disruption of the daily routine and high psychophysiological load, various health disorders of both functional and organic nature may occur and existing pathologies may worsen.

The aim of the study - screening of health of different age categories of the population, based on research of chronotype, sleep quality, seasonal pattern, behavioral time preferences and functional state of body's regulatory and respiratory systems in individuals from the different age groups.

Methods: testing of psycho-physiological functions using Composite Scale of Morningness (CSM), Munich ChronoType Questionnaire (MCTQ), Seasonal Pattern Assessment Questionnaire (SPAQ), Pittsburgh Sleep Quality Index (PSQI); Heart rate variability (HRV); Spirometry; Anthropometry (measurement of height, weight, waist circumference), Blood pressure measurement (BP).

Statistical analyses planned to perform frequency, correlation, factorial and variance analyzes using Statistica 10,0 software ("StatSoft, Inc"). Data investigate by mean value (M) and standard deviation (SD) in case of normal data distribution or nonparametric method with determination of median (Me) and interquantile ranges (25th and 75th percentile) in the case of a distribution other than normal. ANOVA, MANOVA analysis. Statistically significant differences in all statistical tests set to P\<0.05

Eligibility Criteria:
Inclusion Criteria:

conditionally healthy persons, persons with metabolic disorders in the presence of basic criterion MS - abdominal obesity.

Exclusion Criteria:

chronic somatic diseases; infectious diseases; malignant neoplasms of various organs and systems; viral infections; autoimmune diseases; mental illness; pregnancy and lactation in women
The Impact of Neoadjuvant Chemotherapy on Survival Outcomes in Patients With Variant Histologies Bladder Cancer Who Underwent Radical Cystectomy

The World Health Organization 2016 bladder tumor classification reported that the diagnosis of variant histology has increased from 6% to 33% in the last 2 decades, and there is an increasing interest in investigating the effects on disease management, treatment options, and survival outcomes in bladder tumors with variant histology. In bladder tumors, variant histology is known to be more aggressive and has a worse prognosis than pure urothelial cancer, and most cases are muscle invasive at diagnosis. Neoadjuvant cisplatin-containing combination chemotherapy is known to improves overall survival in patients with urothelial cancers. However, it is unclear whether patients with non-pure urothelial cancer (variant) histology will also benefit from neoadjuvant chemotherapy. The investigators aimed to evaluate the role of Neoadjuvant cisplatin-containing combination chemotherapy in the final treatment plan and its impact on survival in patients with bladder cancer who were diagnosed with variant histology in the radical cystectomy specimen.


Eligibility Criteria:
Inclusion Criteria:

* Patients with squamous cell, micropapillary, nested variant, sarcomatoid, neuroendocrine, or plasmacytoid variant histology
* Patients who were non-metastatic at diagnosis
* Patients who completed staging and demographic data,
* Patients with pathological stage (p)T2 or high grade pT1, clinical stage (c)N0 or cN1, and underwent radical cystectomy

Exclusion Criteria:

* Although RC histopathology was variant histology, patients in whom variant histology was not detected in previously transurethral resection bladder pathology
* Patients who received therapies other than radical cystectomy (intravesical bacillus-calmette-guerin or chemotherapy) were excluded from the study.
* Patients with a concomitant diagnosis of upper urinary tract urothelial carcinoma
* Patients with histopathologically pure urothelial carcinoma