cyrilzakka/clinical-trials huggingface dataset:
A Study of LY3819253 (LY-CoV555) in Healthy Participants

The purpose of this study is to test the safety and tolerability of LY3819253 when it is given by injection just under the skin to healthy participants. Blood tests will be done to check how much LY3819253 is in the bloodstream and how long the body takes to eliminate it. Participation could last up to 16 weeks and may include up to six visits to the study center, with a one-week overnight stay.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation including medical history and physical examination
* Are willing to follow study procedures, including having nasal or nasopharyngeal swabs collected
* Have a body mass index (BMI) within the range of greater than or equal to (≥)18.5 to less than (\<)35 kilograms per square meter (kg/m²)
* Male participants must agree to adhere to contraception restrictions
* Female participants must be of non-childbearing potential

Exclusion Criteria:

* Have or have had known or suspected severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
* Have a history or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disorders that, in the opinion of the investigator, are capable of

  * Significantly altering the absorption, metabolism, or elimination of drugs
  * Constituting a risk while taking the investigational product, or
  * Interfering with the interpretation of data
* Have significant allergies to humanized monoclonal antibodies (mAbs)
* Have any of the following that are clinically significant:

  * Multiple or severe drug allergies, or
  * Intolerance to topical corticosteroids, or
  * Severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
* Have had lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
* Have had breast cancer within the past 10 years
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Show evidence of current hepatitis C (that is, test positive for anti-hepatitis C antibody with confirmed presence of hepatitis C virus \[HCV\] ribonucleic acid \[RNA\])
A Phase 1 Study of VG-3927 in Healthy Adults and Patients With Alzheimer's Disease

A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study in Healthy Adults and Open-label Single Dose Study in Patients with Alzheimer's Disease to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VG-3927.


Eligibility Criteria:
Inclusion Criteria:

* The participant is deemed healthy by the principal investigator, as determined by prestudy medical evaluation
* The participant voluntarily agrees to participate in this study and signs an institutional review board approved informed consent

Exclusion Criteria:

* The participant has any concurrent disease or condition that, in the opinion of the principal investigator, would make the participant unsuitable for participation in the clinical study
A Study of Clinical Characteristics ,Risk Factors and Outcome of Lupus Nephritis Among Children With Systemic Lupus Erthromatousus in Sohag Univeristy Hospital

systemic lupus erthrematosus is an inflamatory and autoimmune condition characterized by multisystem affection and chronic course with unpredictable flares despite potentially afffecting every oragan . kidney involvment are the most common


Eligibility Criteria:
Inclusion Criteria:

- aim to include all children fulfilling diagnostic criteria

Exclusion Criteria:

* children with other rheumatological disorder neonates chidren with other nephrolgy disorder
Evaluation of Pressure Sense Threshold and Tactile Sensation After Lidocaine Iontophoresis Using Interferential Current

Drug delivery is conducted through various methods such as injection, phonophoresis, and iontophoresis. Iontophoresis is defined as the noninvasive delivery of active ions through epidermis using direct current. The direct current has some disadvantages such as skin burning and limited time of application. Interferential current is a kind of alternating currents without limitations of direct current; so the purpose of this study was to investigate and compare the effects of Lidocaine, interferential current and Lidocaine iontophoresis using interferential current.

Pressure, tactile, and pain thresholds were evaluated before and after the application of Lidocaine, interferential current and Lidocaine iontophoresis using interferential current. Pressure threshold was investigated with a Pesula. Pesula is a pen-like scaled mechanical device that measures the skin pressure threshold. Pesula was pressed to the skin and pressure threshold was measured in mm. Pain and tactile thresholds were investigated using an electrical stimulator.The intensity was gradually increased to the extent that the participant reported a tingling sensation. The displayed intensity was considered as the tactile sense threshold. Then, the intensity was increased to the extent to be intolerable for the participant and this intensity was considered as the maximum pain threshold. The thresholds were recorded in milliampere.

Lidocaine iontophoresis using interferential current can increase perception threshold of pain, and pressure sense more significantly in comparison to the application of Lidocaine and interferential current alone.

Eligibility Criteria:
Inclusion Criteria:

* healthy women with age between 18 and 25 years old

Exclusion Criteria:

* Systemic disorders,
* neuro-muscular diseases such as diabetes and all forms of neuropathies,
* and use of narcoleptic drugs which may contaminate the results.
* Also, none of the participants were on their menstrual cycle.
JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors

To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.

To assess the safety and tolerability and determine the Recommended phase 2 dose (RP2D) of JAB-3312 in combination with PD1 inhibitor or MEK inhibitor in patients with advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor. Some cohorts must meet specific expression or gene mutation where indicated
* Sufficient organ function
* Participants must have at least 1 measurable lesion as defined by RECIST v1.1
* Must be able to provide an archived tumor sample
* ECOG performance status score of 0 or 1.

Exclusion Criteria:

* History of cancer that is histologically distinct from the cancers under study
* Active or untreated central nervous system (CNS) metastases
* History of pneumonitis or interstitial lung disease (ILD)
* Has active hepatitis B, hepatitis C infection, HIV
* Any severe and/or uncontrolled medical conditions
* LVEF ≤50%
* QTcF \>470 msec
Magnesium Prophylaxis for the Prevention of New-Onset Atrial Fibrillation in Critically Ill Patients

A double-blind, multi-centre, randomized, placebo-controlled, feasibility pilot trial in the prevention of new onset atrial fibrillation of critically ill patients admitted to an ICU.

Most studies of new onset atrial fibrillation (NOAF) in critical illness focus on treatment of this arrhythmia but this innovative study will focus on prevention. Parenteral Mg is a low cost and readily available treatment that may be beneficial for reducing the incidence of NOAF in critically ill patients, with the potential to improve patient centred outcomes and provide a cost effective prophylaxis. The main outcome of this study is to determine if it is feasible to conduct a randomized controlled trial comparing parenteral magnesium sulfate with placebo for the prophylaxis of new onset atrial fibrillation in critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Admitted to a critical care unit with EITHER:

   1. Non-invasive ventilation (including high flow nasal canula) or invasive mechanical ventilation with an expected duration \>24 hours AND/OR
   2. Vasopressor or ionotropic support for shock of any etiology. Shock is defined by the need for one of the following vasopressors/inotropes:

   Dopamine Dobutamine Norepinephrine Epinephrine Ephedirine Milrinone at any dose (if used in conjunction with another agent) Vasopressin (if used in conjunction with another agent)
3. Receiving continuous cardiac monitoring.

Exclusion Criteria:

1. Active atrial fibrillation prior to randomization or pre-existing (permanent or paroxysmal) atrial fibrillation
2. Unlikely to survive \>24 hours or palliative patients
3. Cardiac surgery patients
4. Patients requiring parenteral magnesium therapy (e.g. pre-eclampsia, asthma)
5. Patients receiving dialysis
6. Positive pregnancy test
7. Previously enrolled in this trial
8. Treating physician refuses enrollment
9. Receiving ICU intervention (Non-invasive ventilation including High flow nasal canula, invasive mechanical ventilation or ionotropic support) for \>18h hours
Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis

Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic inflammation in the synovial tissue. Rheumatoid arthritis will eventually result in the destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis is that umbilical cord-derived mesenchymal stem cell (UC-MSCs) has anti-inflammatory effects and thus potentially alleviates the progression of rheumatoid arthritis. The study is to explore the safety and efficacy of UC-MSCs transplantation in treatment of rheumatoid arthritis.

This study was supported by the National Natural Science Foundation of China (30872618)，The Shanxi Province Social Development Public Relations Project (2012K13-02-35), and The Military Medicine and Public Health Plan (CLZ120GA23)

Eligibility Criteria:
Inclusion Criteria:

* All patients fulfilled the classification criteria (2010) for rheumatoid arthritis, man or woman aged from 18 to 70 years old.
* Patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines.
* Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on this trial. Women of child-bearing potential must have a pregnancy test performed within 72 hours prior to initiation of treatment.

Exclusion Criteria:

* Any history of ongoing, significant or recurring infections.
* Any active inflammatory diseases other than RA.
* Significant cardiac or pulmonary disease.
* End-stage renal failure.
* Pregnant or nursing women may not participate due to the possibility of fetal harm or harm to nursing infants from this treatment regimen.
Presepsin in the Diagnosis of Sepsis in Critically Ill Patients

Sepsis is one of the most common causes of death worldwide. It is caused by a complex of inadequate host responses to infection. Sepsis remains a major challenge of modern intensive care medicine. Despite recent improvements, the incidence of sepsis in critically ill patients increases steadily (25%) and mortality rates remain unacceptably high (30%). It is difficult to distinguish the sepsis from the non-infectious systemic inflammatory response syndrome. Early identification of the origin of infection can help dramatically to improve outcome and reduce mortality. That is why clinicians need fast, reliable and specific biomarkers for sepsis recognition.

Comparison between the detection of novel early inflammatory biomarker (PSEP) and the others normally used biomarkers (c-reactive protein - CRP, interleukin 6 - IL6, procalcitonin - PCT) in the early diagnosing of sepsis in the critically ill patients A broad range of clinical and laboratory parameters are combined (Surviving sepsis campaign, international guidelines) for early sepsis identification: white blood cells (WBC), C-reactive protein (CRP), interleukin 6 (IL-6), procalcitonin (PCT).

An ideal biomarker should be a fast and specific increase in sepsis, short half-life, rapid decrease after administration of an effective therapy and fast (bed-side) method of determination. None of the current biomarkers have all of these characteristics.

We investigate the diagnostic accuracy of presepsin compared to other biomarkers (WBC, PCT, IL6, CRP) for infection or sepsis, defined according to Sepsis-3 definition (Singer, JAMA 2016) in adult patients admitted to ICU with suspected sepsis.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* diagnosis of sepsis from qSOFA (quick Subsequent Organ Failures Assessment)
* need of vasopressors for mean arterial pressure (MAP) ≥ 65 mmHg
* lactate levels ≥ 2mmol/l despite adequate volume resuscitation

Exclusion Criteria:

* age below 18 years
* terminal state of disease
* pregnancy
Extramedullary Acute Myeloid Leukemia (eAML): Retrospective Single Center Cohort Study, Clinicopathological, Molecular Analysis and Survival Outcomes

Patients with extramedullary leukemia were identified over 10 years (January 2003 to September 2019). Clinicopathological,genetic-molecular features were identified and survival outcomes were studied and analyzed.

We retrospectively collected patients demographics ,including clinicopathological and genetic-molecular parameters in patients with extramedullary leukemia between January 2003 till September 2019 from King Hussein cancer center(KHCC) electronic medical records. All potential prognostic factors were identified and compared with worldwide data published previously. Treatment and survival outcomes were studies and analyzed.

Primary endpoint : Overall survival (OS).

Secondary endpoint :

* Progression Free Survival (PFS).
* incidence of extramedullary leukemia.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects aged ≥18 year and up to 75 years
* Male and females.
* Initially diagnosed and treated with extramedullary leukemia at KHCC and followed till last encounter.
* Patients, who underwent an allogeneic stem cell transplant.
* Period January 2003-September 2019

Exclusion Criteria:

* Pediatric patients \<18 year of age
* Patients, who lost their follow up within study period.
Cryopreserved-thawed Embryo Transfer With or Without Gonadotropin Releasing Hormone Agonist

Traditionally, the use of GnRH-a suppression was considered essential for adequate endometrial hormonal modulation in cryopreserved-thawed embryo transfer cycles. Several studies, however, have questioned its necessity for controlled endometrial preparation. Using a high dose of estradiol from day 1 of the cycle will suppress the gonadotroph, preventing folliculogenesis and excessive secretion of LH, allowing adequate endometrial preparation without GnRH-a.


Eligibility Criteria:
Inclusion Criteria:

* 20-35 years
* BMI 20-30
* Regular menses.
* No PCOS, no endometriosis
* No uterine anomalies or lesions
* No severe male factor
* All grade 1 cleaved stage embryos

Exclusion Criteria:

* Less than 20 or more than 35 years
* BMI less than 20 or more than 30
* Irregular cycles
* PCOS or endometriosis
* Uterine anomalies or lesions
* Severe male factor
* Poor quality embryos for transfer
* Severe
Evaluation of McGrath® MAC Video Laryngoscope

The purpose of this study is to evaluate whether the McGrath® MAC video laryngoscope is equal or superior when compared to the Glidescope® Ranger and the Macintosh laryngoscope for novice users in a simulated airway manikin.

Investigators compared two portable video laryngoscopes (the GlidesScope® Ranger (Verathon Inc, Bothell, WA, USA) and the McGrath® MAC (Aircraft Medical Ltd, Edinburgh, UK)) and a German type Macintosh metal blade with a fiberoptic light. A blade size of 4 was used on all devices. All intubations using video laryngoscopes were performed according to the manufacturers' instructions. A specialised rigid stylet (the GlideRite®) was used with the Glidescope® and a flexible plastic stylet bent with a hockey stick curvature, was used with the McGrath® MAC and the Macintosh laryngoscope. A size 7.5 endotracheal tube (Mallinckrodt™ Hi-Lo Oral/Nasal Tracheal Tube Cuffed Murphy Eye, Covidien, Ireland) was used with all the laryngoscopes.

All participants were randomly divided into 3 device groups. Each group was allowed to attempt to perform endotracheal intubation five more times using the Laerdal® Airway Management Trainer (Laerdal Medical Korea Ltd., Seoul, Korea) with the normal airway setting. After completing the normal airway session, the participants performed another five attempts with the neck immobilisation setting using a neck collar.

The sequence in which the three devices were used was randomly assigned, and all participants performed the same sequence at intervals of five weeks during the study.

Eligibility Criteria:
Inclusion Criteria:

* Medical students without previous experience of intubation

Exclusion Criteria:

* Heart, wrist, or low back disease or who were pregnant were excluded
Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus

The study will investigate the effects of atorvastatin on the concentrations of small, dense LDL and HDL subfractions in patients with diabetes and the underlying mechanisms of these effects.

This study was terminated on October 6, 2004. The study terminated prematurely because of a higher screening failure rate than expected. There were no safety or efficacy reasons involved in the decision to terminate.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with a diagnosis of type 2 diabetes mellitus who either have never had a major adverse cardiac event (MACE) diagnosed before or who had a MACE diagnosed at least 6 months ago, but who, according to the judgement of the treating general practitioner, do not receive any hyperlipidemic therapy. Major adverse cardiac events (MACE) include myocardial infarction, coronary angioplasty, coronary artery bypass graft or other revascularization procedures.

At Screening:

Visit 1 (week -4):

1. Male patients aged \>35 and ≤75 years and postmenopausal female patients ≤75 years with a diagnosis of type 2 diabetes mellitus
2. Patients have been euthyroid for at least six months
3. Written informed consent obtained

   At Visit 2 (week 0):
4. LDL cholesterol ≥130 mg/dl (3.3 mmol/l ) and \<190 mg/dl (4.9 mmol/l)
5. Triglycerides \<150 mg/dl (1.69 mmol/l ) and \<600 mg/dl (11.3 mmol/l)
6. Sum of LDL-5 and LDL-6 cholesterol ≥25 mg/dl (0.65 mmol/l)
7. Follicle stimulating Hormone (FSH) \>30 U/l in female patients aged \<60 years or FSH \>20 U/l in female patients aged ≥60 years

Exclusion Criteria:

* HbA1c \> 8.0
* Creatine kinase (CK) \>5 times the upper limit of normal
* Patients having taken lipid lowering medication within 8 weeks of the screening visit
Dextenza for Post-operative Treatment of Pterygium

DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation Compared to Standard of Care Topical Cortico-steroid Treatment in Patients who Undergo Bilateral Pterygium Surgery

In patients who undergo bilateral pterygium surgery, eyes will be randomized to receive either DEXTENZA at baseline, Month 1 and Month 2 or prednisolone x 3 months. Both eyes will receive antibiotic drops four times per day for two weeks and Maxitrol ointment at bedtime for two weeks following surgery.

Eligibility Criteria:
Inclusion Criteria: patients with bilateral pterygium -

Exclusion Criteria: none

-
Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With Non Small Cell Lung Cancer (NSCLC)

The second-line treatment in advanced NSCLC has been currently proved effective in prolonging overall survival and improving quality of life. Both pemetrexed and erlotinib have been approved for second-line treatment of NSCLC . Erlotinib is a valuable option for the treatment of advanced NSCLC, especially for elderly patients, due to convenience of administration and safety profile. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.

This trial will compare the efficacy of pemetrexed versus erlotinib in pretreated patients with advanced NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer adenocarcinoma
* Stage IIIB/IV
* Failure to prior chemotherapy
* Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
* Absence or irradiated and stable central nervous system metastatic disease.
* Life expectancy of more than 3 months
* Tissue sample desired for genomic study
* Age ≥ 18 years
* Performance status (WHO) \< 3
* For patients \> 65 years old: "non-frail" according to comprehensive geriatric assessment
* Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9gr/mm\^3)
* Adequate liver (bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl)
* Presence of a reliable care giver for patients \> 65 years old
* Informed consent.

Exclusion Criteria:

* Psychiatric illness or social situation that would preclude study compliance
* Other concurrent uncontrolled illness
* Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Facilitating Assessment of At-Risk Sailors Using Technology

Randomized clinical trial with individuals being allocated to experimental (Cogito Companion) or Active Control arms. Those in the latter will receive information regarding widely available mobile self-help apps via a custom mobile app built in MyCAP. This same platform will be used to collect data regarding symptoms. Randomization will be stratified by gender, force (Surface, Aviation), and smartphone model (Android, I-Phone), as Cogito algorithms differ based on smartphone platforms. Participants will be willing Naval personnel being redeployed to CONUS. Data is also being collected (feasibility/acceptability) to inform future implementation..


Eligibility Criteria:
Inclusion Criteria.

* Member of the Navel Surface or Aviation Forces;
* Age: 18-55 years at the time of enrollment;
* Ability to provide verbal and electronic informed consents;
* Ownership of smartphone;
* Willingness to use smartphone and personal data plan to participate.

Exclusion Criteria.

* Having redeployed (returning to the Continental United States) more than twelve months (approximately) prior to consent.
* Having an iPhone (until later in 2019 when the Cogito Corporation plans to release the iOS version of the Cogito Companion app).