cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine When Administered in Children Who Previously Participated in Study 115345

The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals' investigational vaccine GSK2321138A in children who previously participated in study 115345 (FLU D-QIV-004 PRI) (NCT01439360).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that parent(s)/LAR(s) can and will comply with the requirements of the protocol.
* Children, male or female who received a 2-dose vaccination in the study 115345 (NCT01439360).
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Subjects in stable health as determined by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Since the start of study 115345 (NCT01439360), receipt of any seasonal influenza vaccine other than the study vaccines of study 115345 or planned administration of any influenza vaccine other than the study vaccine during the study.
* Administration of any vaccine not foreseen by the study protocol within 4 weeks preceding the first dose of study vaccine or planned use until Visit 2.
* Laboratory confirmed influenza infection outside of the 115345 (NCT01439360) study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to enrolment in the study or planned administration during the study period. Inhaled and topical steroids are allowed.
* Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Any contraindication to intramuscular injection.
* Acute disease and/or fever at the time of enrollment:

  * Fever is defined as temperature ≥ 37.5°C by any route.
  * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
* Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
Does Oral Magnesium Substitution Relieve Pregnancy Induced Leg Cramps ?

This is a trial of treatment with tablets containing magnesium for leg cramps in pregnancy.

Healthy pregnant women between 18 and 36 weeks of pregnancy suffering from leg cramps at least twice a week were treated with magnesium tablets or placebo for two weeks, 120 mg x 3 daily.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with recurrent leg cramps (at least twice a week).
* No disease according to helath certificate. Written participation consent must be signed.
* Linguistic ability demanded: Norwegian as the first language. Gestation length more than 17 weeks, less than 36 weeks.

Exclusion Criteria:

* Twin pregnancy.
* Oedema.
* Pre-eclampsia.
* Magnesium supplementation beyond the trial treatment.
Recombinant Human Brain Natriuretic Peptide for the Recovery Stage of Septic Shock

As infection control improves and circulation stabilizes, treatment de-escalation of septic shock begins, accompanied by fluid redistribution from interstitial spaces to the vasculature, increasing cardiac volume load. Synthetic recombinant human BNP (rh-BNP) plays a role in inducing vasodilation, particularly in the venous system, alleviating cardiac congestion, and enhancing natriuresis and diuresis. Thus the investigators designed a single-center, prospective physiological study to evaluate the efficacy of standard rh-BNP infusion in reducing venous return and enhancing fluid removal, with a secondary objective of assessing the maintenance of perfusion pressure and tissue perfusion.


Eligibility Criteria:
Inclusion Criteria:

1. Sepsis-3 criteria met with Sequential Organ Failure Assessment (SOFA) score increase ≥2 points due to suspected/documented infection.
2. Hypotension persisting after initial fluid resuscitation with concurrent hyperlactatemia at shock diagnosis.
3. Hemodynamic stability achieved after adequate initial resuscitation and individualized hemodynamic optimization.
4. Controlled infection source with improving temperature, white blood cell (WBC) count, and procalcitonin.
5. 48-hour trend of decreasing vasopressor requirements and transition to negative fluid balance.
6. Ongoing pulse index continuous cardiac output (PiCCO) hemodynamic monitoring and sinus rhythm.
7. Volume indicators above the lower limit of normal range, with global end-diastolic volume index (GEDI) \>680 mL/m² and central venous pressure (CVP) \>8 mmHg8.
8. Adequate perfusion with warm extremities, and capillary refill time (CRT) \<3 seconds9.
9. Signs of cardiac dysfunction: BNP\>20010 or NT-proBNP \>900 pg/ml6 or reduced ejection fraction (LVEF \< 50%).
10. No bonus dose of diuretics has been used in the past 6 hour.

Exclusion Criteria:

1. Age \<18 years.
2. Pregnancy or lactation.
3. Arrhythmia.
4. Persistent dependence on moderate-dose vasopressors (norepinephrine equivalent 0.1-0.3 μg/kg/min) to maintain systolic blood pressure (SBP) \<90 and mean arterial pressure (MAP) ≥65 mmHg.
5. Advanced renal dysfunction (Acute Kidney Injury \[AKI\] stage 3 or Chronic Kidney Disease \[CKD\] stage 3b or higher) based on Kidney Disease: Improving Global Outcomes (KDIGO) criteria.
6. Inadequate ultrasound window preventing acquisition of diagnostic-quality images.
7. Altered mental status impeding patient cooperation.
8. Trauma or neurological diseases (including intracerebral hemorrhage and cerebral infarction).
9. Pre-existing severe heart failure (New York Heart Association \[NYHA\] class III-IV) or acute myocardial infarction within the past 30 days.
10. Concurrent enrollment in interventional trials that could confound study outcomes.
11. Inability or unwillingness to provide informed consent.
Beta Amyloid PET Imaging for Alzheimer Disease With [18F]-Fluselenamyl

The purpose of this research study is to determine the safety of a radiotracer 18F-Fluselenamyl using positron emission tomography (PET) imaging.

The investigators will first complete whole-body PET dosimetry studies in healthy adult normal volunteers to calculate the actual radiation dose of each human organ and determine the allowable dose for a human subject when receiving a single dose for a PET scan.

Second, imaging of the brain and neck will be completed in a wide range of ages of healthy adult normal control participants and participants with mild cognitive impairment, both male and females to characterize 18F-Fluselenamyl uptake in the brain, its binding to beta-amyloid plaques, and radiolabeled metabolite will be completed. Amyloid is a protein related to dementia of Alzheimer's disease. 11C-PIB PET imaging and MRI of the brain will also be completed in the same participants and the data will be compared with 18F-Fluselenmayl. 11C-PIB and 18F-Fluselenamyl both bind to beta-amyloid plaques.

Finally, a comparison of the normal control participants to patients with Alzheimer's disease will be completed.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, any race
* Age ≥ 18 years
* Healthy volunteers or volunteers with Alzheimer's disease

Exclusion Criteria:

* Has hypersensitivity to 18F-Fluselenamyl or any of its excipients ;
* Has hypersensitivity to 11C-PIB or any of its excipients ;
* Incapable of providing written informed consent or lacking a legally authorized representative (LAR) to provide informed consent ;
* Unwilling or unable to undergo PET scans tracer injections ;
* Unwilling or unable to undergo MRI (Aim 2 and Aim 3)
* Any condition that, in the Investigator's opinion, could increase the risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., renal or liver failure, advanced cancer);
* Women who are currently pregnant or breast-feeding;
* Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1.
Open Label Study of DS-5573a

This is an open-label, sequential dose escalation and expansion study to evaluate the safety, and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.
* Eastern Cooperative Oncology Group performance status(PS) of 0 or 1

Exclusion Criteria:

* Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment:

Cardiac failure (NYHA ≥ ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, uncontrolled deep-vein thrombosis or clinically severe thromboembolic event, or autoimmune disorders requiring treatment.

* Severe or uncontrolled concomitant disease.
* Clinically active brain metastases defined as symptomatic or requiring treatment.
Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Hospitalized Patients With AECOPD

The purpose of this study is to assess the feasibility, safety and efficacy of a combination of nebulized Formoterol and Revefenacin among patients hospitalized for AECOPD compared with standard-of-care therapy with nebulized Albuterol and Ipratropium.

A prospective, parallel group, randomized clinical trial in 60 patients hospitalized with the primary diagnosis of AECOPD or acute respiratory failure with a secondary diagnosis of COPD (ICD-10 codes J44.1 and J96 - J96.2 with J44.9).

The plan is to:

Administer standard bronchodilator protocol with nebulized Albuterol and Ipratropium every 6 hours (n=30)

versus

Nebulized Revefenacin 175 μg once per day and Formoterol 20 μg twice per day (n=30) for up to 7 days of treatment. Study medication will be administered by standard jet nebulizers in both groups.

Investigators will:

* Collect the Borg dyspnea scale twice a day during hospitalization
* Record the total doses of bronchodilators per day received by each patient
* Record the number of rescue doses needed per day of hospital stay
* Record the lowest level of FiO2 employed on days 1, 3 and 7 of hospital stay
* Record all adverse events and concurrent medications

Investigators will collect:

Physical Exam (Day 1, 3, 7, or ET) Serum Chemistry (Day 1, 3, 7, or ET) Hematology (Day 1, 3, 7, or ET) Chest X-Ray (Day 1).

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female
2. Any Race
3. ≥ 40 years of age
4. Admitted to the hospital with a primary diagnosis of AECOPD or acute respiratory failure with a secondary diagnosis of COPD
5. Able to understand and comply with study procedures
6. Willingness to sign and date an Informed Consent Form

Exclusion Criteria:

1. Patients unable or unwilling to sign an informed consent or cooperate with study procedures
2. Patients who are hypersensitive to Formoterol or Revefenacin
3. Patients who are intubated, have tracheotomy, are receiving mechanical ventilation by mask or artificial airway
4. Patients, in the opinion of the investigators, who are rapidly decompensating and are immediately in need, or will soon need, ventilator support
5. Patients who, per the investigator, have unstable cardiovascular disease (e.g., uncontrolled, hypertension, unstable angina, recent MI (within 12 weeks), ventricular arrhythmia, or decompensated heart failure)
6. Patients with a current diagnosis of lung cancer requiring treatment
7. Patients that test positive for COVID-19
8. Pulmonary diseases other than COPD, or lobar pneumonia
9. Patients with acute psychiatric illness deemed significant by the investigator
10. Patients with a history of glaucoma deemed significant by the investigator
11. History of urinary retention deemed significant by the investigator

12 Women who are pregnant or breast feeding
A Study of FZ-AD004 in Patients with Advanced Solid Tumors

This study is one single group of participants with advanced solid tumors. It is the first time the drug has been used in humans. There will be two parts including Dose Escalation and Dose Expansion to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of FZ-AD004.

This is a first-in-human (FIH), Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of FZ-AD004 in patients with advanced/metastatic solid tumors. FZ-AD004 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD) and dose-limiting toxicities（DLT）during cycle 1. In addition, the maximum-tolerated dose and recommended Phase II dose for FZ-AD004 will be determined.

Eligibility Criteria:
Inclusion Criteria:

1. Patients able to give written informed consent;
2. Age ≥ 18 and ≤ 75 years old, male or female;
3. Patients have histological or cytological diagnosis with advanced solid tumors.
4. Have measurable lesions defined in RECIST v. 1.1;
5. Expected survival ≥ 12 weeks;
6. Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
7. Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.

Exclusion Criteria:

1. Have had other malignant tumors in the past 5 years;
2. Have CNS (central nervous system) metastasis with clinical symptoms;
3. Had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
4. Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment;
5. Have history of psychotropic drug abuse, alcohol or drug abuse；
6. Women who are pregnant or lactating；
7. Other circumstances that is deemed not appropriate for the study.
Post-Operative Pain and Opioid Reduction Trial After Bunionectomy

This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing bunionectomy.

Near the completion of surgery, a single dose of study drug (CPL-01, saline placebo, or ropivacaine HCl) will be infiltrated. Subjects will remain in the hospital/research facility for a minimum of 72 hours after the start of study drug administration to undergo postoperative assessments. Subjects will return to the study site on Day 7 to complete follow up assessments, on Day 28 for follow-up assessments including an X-Ray, and on Day 42 for the end-of-study (EOS) visit.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to sign the informed consent form (ICF) prior to study participation
* In the medical judgment of the Investigator, be a reasonably healthy adult 18 - 75 years of age, inclusive, and ASA Class I or II at the time of randomization
* Plan to undergo an elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries
* Have a BMI ≤ 39 kg/m2

Exclusion Criteria:

* Previous unilateral simple bunionectomy
* Has a planned concurrent surgical procedure that may impact pain scores, rescue medication use, or ability to fulfill the requirements of the protocol
* Concurrent painful condition
* Active skin disease or other clinically significant abnormality at the anticipated surgical site that could interfere with the planned surgery
* Known hypersensitivity or known allergy, as determined by the Investigator, to the ingredients (i.e., excipients) of the study drug or any peri- or postoperative medications used in this study
* History or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments
* History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency
* History or evidence of impaired liver function (e.g., ALT \> 3 × upper limit of normal \[ULN\] or total bilirubin \> 2 × ULN), active hepatic disease, or cirrhosis
* History or evidence of impaired renal function (e.g., creatinine \> 1.5 × ULN)
* History of malignancy in the past year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized in situ carcinoma of the cervix
* Has or has had active COVID-19 infection within 3 months prior to surgery
Safety and Efficacy of Combination Acthar Gel and Tacrolimus in the Treatment of Steroid Resistant Nephrotic Syndrome

The management of steroid-resistant nephrotic syndrome (SRNS) remains a persistent problem for investigators in part because of the wide array of pathogenic cccccccccc mechanisms that contribute to these disorders as well as the lack ofs. While glucocorticoids remain the primary therapy for many forms of protein uric glomerularxxxxxxxxx diseases, prolonged use is associated with significant morbidities including steroid induced diabetes, metabolic bone disease, and excessive weight gain.

Multiple agents have been investigated in the treatment of patients with SRNS, but there is no consensus on what constitutes optimal therapy. Previous studiesoids and have shown complete and partial response rates between 40% and 60%. More recently, calcineurin inhibitors (CNI) have become an effective second line therapy with similar response rates between 50%-70%. However, both treatment regiments are limited by the risk for infection as well as the development of vvvvvvv CNI-induced nephrotoxicity and progressive renal disease. Acthar gel is a porcine pituitary preparation composed of ACTH and for treatment of idiopathic nephrotic syndrome. Previous studies, as well as more current studies, have shown that ACTHar gel can effectively reduce proteinuriammmmmmmm in idiopathic membranous glomerulonephritis and other forms of glomerulopathy including focal segmental glomerulosclerosis (FSGS) and advanced diabetic nephropathy. While the mechanism is unknown, previous studies have shown that melanocortin 1-receptors are expressed in glomerular podocytes and thatpathway could be involved in the protein lowering effects of ACTHar bbbbbbbbgel. Incubation of cultured podocytes with ACTH leads to activation of MCR-1 receptors and the subsequent stimulation of protein kinase A (PKA) through a G-protein-dependent pathway. The downstream phosphorylation and stabilization of Rho GTPases, synaptopodin and other cell-cytoskeletal associated proteins may stabilize podocyte function and density.

Eligibility Criteria:
Inclusion Criteria:

* refractory nephrotic syndrome secondary, defined as subjects having a urine protein/Cr ratio over 3.0 while actively receiving ACE inhibitors and hyperglycemic therapy (i.e., insulin or oral hyperglycemic agents).
* Type I or Type II diabetes
* receiving combination therapy with an ACE inhibitor and a second protein lowering agent (e.g., ARB, non dihydropyridine CCB, or spironolactone).

Exclusion Criteria:

* known primary or secondary membranous glomerulonephritis (GN)
* primary or secondary focal segmental glomerulosclerosis
* other nondiabetic forms of glomerulopathy
Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)

This is a randomized, double-blind, controlled, parallel-group, multicenter, Phase-3 study to evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages 10-17 years with Heterozygous Familial Hypercholesterolemia.

This study consisted of 3 distinct periods. In Period 1, subjects received daily treatment for 6 weeks as part of either the ezetimibe with simvastatin group or part of the simvastatin monotherapy group. Subjects in the ezetimibe with simvastatin group received one of three treatments: coadministration of ezetimibe 10 mg/day plus simvastatin 10 mg/day, 20 mg/day, or 40 mg/day. Subjects in the simvastatin monotherapy group received one of three treatments: ezetimibe placebo plus simvastatin 10 mg/day, 20 mg/day, or 40 mg/day. The primary and key secondary efficacy analysis were based on the evaluations performed during Period 1 and were presented as data for subjects pooled from either the ezetimibe with simvastatin treatment groups compared with data for subjects pooled from the simvastatin monotherapy treatment groups.

In Period 2, subjects received ezetimibe 10 mg/day plus simvastatin 40 mg/day or ezetimibe placebo plus simvastatin 40 mg/day for 27 additional weeks maintaining the same treatment assignment (coadministration vs monotherapy) as in Period 1.

In Period 3, all subjects received ezetimibe 10 mg/day plus open-label simvastatin daily for 20 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent (ages 10 - 17 years) boys or girls weighing at least 88 lbs (40 kg).
* Subjects must have high cholesterol (low density lipoprotein cholesterol \[LDL-C\] more than 159 mg/dL or 4.1 mmol/L) and a family history of high cholesterol.

Exclusion Criteria:

* Subjects diagnosed with delayed puberty.
* Subjects who are sensitive to simvastatin and/or ezetimibe.
* Subjects who drink alcohol excessively or who have a history of alcohol or drug abuse within the past 2 years.
* Subjects who are known to be HIV positive, are undergoing LDL apheresis or plasma apheresis, or have had a partial ileal bypass.
Playtime Open Globe Injuries in Children

This study investigated the epidemiology, aetiologies, and complications of playtime open-globe injuries in children at the Assiut University Hospital, Egypt, between January to July 2016.

This prospective study was conducted at the Department of Ophthalmology, Assiut University Hospital, which is the largest tertiary referral hospital in Upper Egypt and provides 24-hour ophthalmic emergency services for six governorates. The study included all children (age ≤18 years) admitted with open-globe injuries that occurred during playtime over a 6-month study period. Demographic information (age and sex), the site and mechanism of injury, the site of ocular laceration (corneal, scleral or corneoscleral) and associated complications were recorded and analysed.

Eligibility Criteria:
Inclusion Criteria:

* all children (age ≤18 years) admitted with open-globe injuries that occurred during playtime over a 6-month study period (January-July 2016).

Exclusion Criteria:

* Open globe injuries in patients olader than 18 years.
* Closed globe injuries
Effect of GnRH Antagonist vs Agonist Long on IVF Outcome, Peak Estradiol Level,and Duration of Stimulation

The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for assisted reproduction affects IVF outcome, peak estradiol level, and duration of stimulation.

No detailed description

Eligibility Criteria:
Inclusion Criteria:

* Ages 21-40 (inclusive up to 41)
* Day 2-4 FSH \< or equal to 10
* Antimullerian Hormone (AMH) greater than or equal to 1.0
* Between 5 and 20 antral follicles on day 2-4
* Body Mass Index (BMI)\>or equal to 18 and \< or equal to 32

Exclusion Criteria:

* Smokers
* Polycystic Ovarian Disease
* Endometriosis greater than Stage I
* Testicular aspirated sperm