cyrilzakka/clinical-trials huggingface dataset:
A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma

The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in subjects with resected advanced melanoma requiring adjuvant treatment with pembrolizumab.

Eligible subjects will be randomized in a 1:1:1 ratio to receive either GME751, Food and Drug Administration (FDA)-licensed pembrolizumab (Keytruda-US) or European Union (EU)-authorized pembrolizumab (Keytruda-EU). The maximum study duration for a participant will be approximately 28 weeks including screening.

Treatment duration is 24 weeks (4 treatment cycles, each of 6 weeks duration). However, subject should discontinue study participation in case of disease recurrence, unacceptable toxicity or other reasons.

Participants who are benefiting from treatment with pembrolizumab without signs of recurrence or unacceptable toxicity will be eligible for continued pembrolizumab treatment via most suitable option based on the respective country regulations.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Advanced Melanoma
* Completely removed melanoma by surgery performed within 13 weeks of randomization
* Adequate organ function
* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

* Known history or evidence of ocular or uveal melanoma
* Known history of hypersensitivity (grade ≥3) to pembrolizumab or its excipients
* Known History of auto-immune disease
* Received live vaccine ≤30 days before the first study treatment
* Prior treatment with anti-PD-1 agents or agent against another stimulatory or co-inhibitory T cell receptor
* Active autoimmune disease that has necessitated chronic systemic treatment within 2 years before the first study treatment

Other protocol-defined inclusion/exclusion criteria apply
Correlation Between Left Ventricular Global Strain Measured by Speckle Tracking Echocardiography and Scar Burden Measured by Cardiac Magnetic Resonance Imaging in Patients With Ischemic Heart Disease

To verify whether GLS and LV mechanical dispersion, measured by two-dimensional speckle-tracking echocardiography (2D-STE) correlate with LV scar burden measured by cardiac MRI in patients with ischemic heart disease.

Evaluation of presence, localization, and extent of left ventricular(LV) scar tissue in patients with ischaemic heart disease (IHD) is of fundamental importance in clinical practice. It affects the decision making regarding revascularization and is a determinant of subsequent mortality. (Mele, Fiorencis et al. 2016) Late gadolinium contrast-enhanced cardiac magnetic resonance (LGE-CMR) is considered the current gold standard technique for assessment of the scar burden in IHD patients. However, it is not readily accessible in many areas due to availability and cost issues.(Abou, Prihadi et al. 2020), (Bendary, Afifi et al. 2019) Several recent studies suggested 2-D speckle tracking strain as a potential surrogate for cardiovascular magnetic resonance (CMR) late gadolinium enhancement (LGE) imaging. This would be useful in cases where CMR is not available, gadolinium contrast is contraindicated, or in patients at greater risk of adverse long term events. (Erley, Genovese et al. 2019) Among echocardiography derived strain measurements, global longitudinal strain (GLS) was shown to be superior to global circumferential strain (GCS) in its ability to detect subtle myocardial abnormalities due to better reproducibility (Erley et al, 2019). Left ventricular mechanical dispersion (LVMD) is also considered a valuable parameter that was associated with outcomes after myocardial infarction. (Abou, Prihadi et al. 2020).

Despite the growing number of strain related studies in the literature, it is not clear whether the relationship of strain measurements with LGE is strong enough for strain to be considered as a surrogate. (Erley, Genovese et al. 2019). Also, the differences between GLS and LV MD among strain components in this context are not well established.

Eligibility Criteria:
Inclusion Criteria:

* • Patients presenting for viability assessment in to cardiac MRI unit, Assiut university heart hospital, with a history of previous stemi, at least 3 months after the acute event ( scar stabilization) and up to one year

Exclusion Criteria:

* Patients with:

  * Contraindication to cardiac MRI (claustrophobia, Patients with eGFR below 30 mL/min/1.73 m2. and patients with metallic implants)
  * Non-ischemic cardiomyopathy.
  * Valvular heart disease (VHD).
Satavaptan Dose-Ranging Study in the Prevention of Ascites

The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period.

This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).


Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence
* Patients having undergone therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of ≥4 L of fluid
* Patients having undergone at least 1 other therapeutic paracentesis in the previous 3 months

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Subjects

This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese hypertensive subjects. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 20 years or older at informed consent
* Subjects with essential hypertension (Sitting SBP ≥ 140 mmHg and \< 180 mmHg, Sitting DBP ≥ 90 mmHg and \< 110 mmHg,and 24h-hr blood pressure more than 130 mmHg in SBP and 80 mmHg in DBP)

Exclusion Criteria:

* Secondary hypertension or malignant hypertension
* Diabetes mellitus with albuminuria
* Serum potassium level \< 3.5 or ≥ 5.1 mEq/L
* Reversed day-night life cycle including overnight workers
* eGFR \< 60 mL/min/1.73 m\^2
Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia

The purpose of this study is to determine whether prophylaxis with micafungin is effective in the induction chemotherapy for newly diagnosed acute leukemia patients.

Medically fit patients with newly diagnosed acute leukemia received 50 mg micafungin intravenously once daily from the initiation of first induction chemotherapy to recovery of neutrophil count, suspected fungal infection, or unacceptable drug-related toxicity.

Eligibility Criteria:
Inclusion Criteria:

A. patients belong to either A-1 or A-2 A-1. patients with newly diagnosed acute myeloid leukemia who approve to get induction chemotherapy with (cytarabine plus idarubicin) or (modified Fludarabine + cytarabine + idarubicin ) A-2. patients with newly diagnosed acute lymphoid leukemia who approve to get induction chemotherapy with VPDL (vincristine + prednisolone + daunorubicin + L-asparaginase), C-VPDL (cyclophosphamide + vincristine + prednisolone + daunorubicin + L-asparaginase), or (R)-hyperCVAD ((Rituximab) + cyclophosphamide + vincristine + Adriamycin + dexamethasone) B. Eastern Cooperative Oncology Group performance status score is equal to or more than 2 C. patients who voluntarily sign the agreement

Exclusion Criteria:

A. evidence of proven/probable/possible fungal infection within 30 days before induction chemotherapy B. hypersensitivity to echinocandin C. patients had other malignancy within 5 years D. previous treatment history with chemotherapy, radiation therapy, or immunosuppressive therapy.

E. pregnant or breast-feeding women F. immunodeficient patients including AIDS G. patients with uncontrolled seizure or psychiatric disorder H. clinically significant heart disorder (myocardial infarction within 3 months or left ventricular ejection fraction \< 40%) I. interstitial lung disease J. previous organ transplantation history K. galactose intolerance L. patients who participated this study before.
An Observational Follow-up Study to Evaluate Duration of Treatment Effect of Pentosan Polysulfate Sodium in Participants With Knee Osteoarthritis Pain

The purpose of this study is to measure the duration of treatment effect with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adult participants with knee osteoarthritis (OA) pain. The study duration will be up to 34 weeks.

Participants who completed pDay 162 of Study PARA_OA_002 (i.e. did not discontinue/withdraw prematurely from the parent study) will be invited to participate.

This is an observational study to determine duration of treatment effect and assess long-term safety up to 52 weeks post PPS use for 6 weeks in parent study (PARA_OA_002). The duration of treatment effect will be evaluated by the OMERACT-OARSI responder criteria for knee OA.

Eligible participants will be enrolled in Study PARA_OA_006 at the completion of the parent study PARA_OA_002. There will be no intervention in this observational study.

Participants will attend screening (visit 1), three phone visits at 8, 16, and 24 weeks, and an EOS (end of study) visit 34 weeks at the site, a total of 5 visits. Participants questionnaires include WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) NRS 3.1 Index, PGIC (Patients Global Impression of Change), WPAI (Work Productivity and Activity Impairment) and quality of life SF-36.

Eligibility Criteria:
Inclusion Criteria:

* Participants who completed Day 168 of Study PARA_OA_002 (ie, did not discontinue/withdrew prematurely from the parent study).
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

• An employee of the Sponsor, clinical research organisations or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted.
An Extension Study of JR-141 in Patients With Mucopolysaccharidosis Type II

Multicenter, open-label, single-group, designed to evaluate the long term efficacy and safety of study drug for the treatment of the MPS II.


Eligibility Criteria:
Inclusion Criteria:

1. A patient who participated in the preceding Study JR-141-301 and completed the Week 52 visit, and has no safety concerns to enter this study in the opinion of the investigator or subinvestigator.
2. A patient capable of providing written informed consent in person (However, this is not required for patients aged younger than 20 years at the time of consent or patients with intellectual disability associated with MPS II whose willingness cannot be verified.)
3. For patients aged younger than 20 years at the time of consent or patients with intellectual disability associated with MPS II whose willingness cannot be verified, written consent must be obtained from the legally acceptable representative. (Wherever possible, written consent of the patient should be obtained.)
4. Male patient whose partner is of child-bearing potential and agrees to use a medically accepted, highly effective method of contraception.

Exclusion Criteria:

1. A patient who used any concomitant medication or therapy that could affect study assessments in the opinion of the investigator or subinvestigator.
2. A patient with a history of serious drug allergy or hypersensitivity that precludes participation in this study in the opinion of the investigator or subinvestigator.
3. A patient judged to be ineligible by the investigator or subinvestigator for other reasons.
Normalizing CO2 in Chronic Hyperventilation by a Novel Breathing Mask: A Pilot Study

Background: Chronic Idiopathic Hyperventilation (CIH) is a form of dysfunctional breathing which has proven hard to treat effectively. The investigators hypothesised that by periodically inducing normocapnia over several weeks, it would be possible to raise the normal resting level/set point of CO2 and achieve a reduction of symptoms.

Methods: Six CIH patients were treated two hours a day for four weeks with a novel breathing mask. The mask was used to induce normocapnia in these chronically hypocapnic patients.

Capillary blood gases (PcCO2, pH, Standard Base Excess (SBE) etc.) were measured at baseline and once each week at least three hours after mask use, as well as spirometric values, breath holding tolerance and hyperventilation symptoms as per the Nijmegen Questionnaire (NQ),.


Eligibility Criteria:
Inclusion Criteria:

Chronic idiopathic hyperventilation, i.e.:

* PCO2 level below 4.7 kPa AND
* SBE value more negative than -1.0

Exclusion Criteria:

* Oxygen saturation of 95% or lower at rest
Jerusalem Handwashing Study

The primary objective of this preschool intervention trial was to determine whether a hygiene program can promote handwashing and thereby reduce illness absenteeism.

Please see citations of published reports.

Eligibility Criteria:
Inclusion Criteria:

* Preschool teachers of 3- and 4-year-old children in the state-run public system of the Jerusalem region, who were recommended by their supervisors as being likely to comply with the protocol.

Exclusion Criteria:

* Exposure to project during testing phase (N=1 preschool), preschool which included new Ethiopian immigrants who were unlikely to have phones or speak Hebrew (N=1 preschool)
* Project staff knew teachers personally and thought they would not comply with protocol (N=2 teachers).
Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children

To determine the tolerability and safety of FLUVAL P monovalent influenza vaccine in children.

This is an open, uncontrolled study to assess safety and tolerability of Fluval P monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children of 6-36 months of age. The vaccination is not repeated.

Tolerability and safety (incidence of adverse events) of the study drug is assessed after Day 28 then after Day 180-210 following the vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 to 36 months, both sexes;
* Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study;
* Capability of the legitimate representative of the volunteer to understand and comply with planned study procedures;
* Legitimate representative of the volunteer provide written informed consent prior to initiation of study procedures;
* Absence of existence of any exclusion criteria.

Exclusion Criteria:

* Known allergy to eggs or other components of the vaccine (in particular mercury);
* History of Guillain-Barré syndrome;
* Active neoplasm;
* Former or on-going immunosuppressive therapy;
* Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
* Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
* Documented HIV, HBV or HCV infection;
* Chronic illness that, in the opinion of the investigator, may have effect on the participation in the study;
* Acute febrile respiratory illness within one week prior to vaccination;
* Vaccine therapy within 4 weeks prior to vaccination;
* Influenza vaccination within 6 months prior to vaccination;
* Experimental drug therapy within 1 month prior to vaccination;
* Past or current psychiatric disease of the legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the legitimate representative;
* Alcohol or drug abuse of the legitimate representative.
Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects

This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1720 administered subcutaneously (SC) or intravenously (IV).

Participants will be randomized in a 3:1 ratio to receive the active treatment or placebo.

The study will be conducted in healthy adult participants, including participants of Japanese descent.

Eligibility Criteria:
Inclusion Criteria:

* Body weight within 50 to 90 kilograms (kg), inclusive, and body mass index within the range of 18 to 29.9 kg/meter squared, inclusive.
* Willing to follow protocol-specified contraception guidance while on treatment and for 6 months after the last dose of study treatment.
* Vaccination with tetravalent meningococcal conjugate vaccine and serogroup B meningococcal vaccine.
* No clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory evaluation.
* For the cohorts with Japanese participants, parents and grandparents must both be Japanese, and participants must have resided for less than 5 years outside of Japan.

Exclusion Criteria:

* Current or recurrent disease that could affect clinical assessments or clinical laboratory evaluations.
* History of complement deficiency or complement activity below the reference range.
* Female participants who are breastfeeding.
* Immunization with a live-attenuated vaccine 28 days prior to dosing on Day 1 or planned vaccination during the course of the study. Immunization with inactivated or recombinant influenza vaccine, or nucleoside-modified messenger ribonucleic acid or recombinant COVID-19 vaccine is permitted.
* Current tobacco smoking, history of illicit drug abuse, or history of significant alcohol abuse.
Effects of Minimal and High Flow Anesthesia on Thiol Disulfide Balance and StO2 in Hypotensive Anesthesia Applications

The effects of Minimal Flow Anesthesia (0.4 l / min) and High Flow Anaesthesia (2 l / min) on tissue oxygen saturation (St02) and thiol / disulfide balance in hypotensive anesthesia operations will be investigated.

The oxidative stress at the cellular level and the possible effects of general anesthesia techniques on the antioxidant system make the method of anesthesia more important.

The effects of Minimal Flow Anesthesia (0.4 l / min) and High Flow Anaesthesia (2 l / min) on tissue oxygen saturation (St02) and thiol / disulfide balance in hypotensive anesthesia operations will be investigated.

Minimal flow anesthesia is widely used because of its advantages such as cost reduction, prevention of environmental pollution, minimization of heat and humidity loss.

Hypotensive anesthesia is preferred in some specialized surgical procedures in order to reduce bleeding and improve the surgical field of view.

The use of hypotensive anesthesia and inhalation agents may cause hypoperfusion at the tissue level and cause hypoxia-induced oxidative stress and initiate cell damage.

Determining the ideal anesthesia technique in terms of oxidative stress and tissue perfusion will reduce intra- and postoperative risks by protecting patients from the harmful effects of anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists) I tympanoplasty operations with hypotensive anesthesia,
* ASA (American Society of Anesthesiologists) II tympanoplasty operations with hypotensive anesthesia,

Exclusion Criteria:

* operations in less than one hour
* uncontrolled hypertension
* DM (Diabetes Mellitus)
* cerebrovascular disease
* coagulopathy
* morbid obesity ((BMI ≥ 35)
* renal disease
Clinical Characteristics and Outcomes of SLE Patients Admitted to Critical Care Unit

The aim of the present work is to determine the frequency of critical complications of SLE patients admitted to the intensive care unit,study the risk factors and out comes.

Systemic lupus erythematosus (SLE) is a systemic heterogeneous autoimmune disease with a highly variable course and prognosis that many different organs may be affected . It has wide spectrum of clinical presentation that affects all ages and ethnicities . Child-bearing women most often afflicted by this diseases, but with different disease manifestations and with variable severity .

The pathogenesis of SLE is complex and still largely unknown. Genetic, environmental, and hormonal factors contribute to disease susceptibility . The diagnosis of SLE is based on characteristic clinical findings of the skin, joints, kidneys, and the central nervous system, as well as on serological parameters such as antinuclear antibodies (ANA) . SLE mainly causes damage to the kidney, heart, joints, blood vessels, liver, lungs and the nervous system . Since SLE is a heterogeneous disease, its complications may vary and the severity or intensity depends on the area affected. Pulmonary hypertension, alveolar haemorrhage, thrombocytopenia, catastrophic antiphospholipid syndrome (APS), haemolytic anemia, neutropenia, blood cancer and thrombotic thrombocytopenic purpura, atherosclerosis, pericardial tamponade myocarditis, heart failure, arthritis, vasculitis, adrenal insufficiency, lupus nephritis (LN), neuropsychiatric disorders, pancreatitis, and myelitis are some of the major complications of SLE . In a previous study on Egyptian SLE patients, pleuro-pulmonary system was found to be one of the most commonly affected systems; pleurisy being the most frequent clinical finding followed by pulmonary infection and disease activity was an important predictor for infection .

Lupus flares and infections are the most common causes of admission to the ICU in patients with SLE. Pertaining to complications from infections, lower pulmonary tract infections are typically more severe and frequent.

A number of studies have addressed the characteristics and outcomes of critically ill SLE patients. In a cohort of 2870 SLE patients retrieved from a national database, the leading causes of ICU admission were found to be infections and organ dysfunction (neurological, cardiovascular, and respiratory systems).

Ethnic differences, availability of therapy, and health-care referral systems may impact SLE manifestation and prognosis. Few studies have provided a clinical characterization of SLE patients admitted to the ICU, and data on predictors of patient outcomes are discordant.

Eligibility Criteria:
Inclusion Criteria:

* SLE Patients Admitted to ICU.

Exclusion Criteria:

* Patients who stayed \<48 h in ICU.
* Patients with major chronic organ disease not related to SLE or terminal cancer.