cyrilzakka/clinical-trials huggingface dataset:
Trial to Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and to Compare Safety, Effect on Quality of Life, and Resource Utilization of Injectafer vs Intravenous Standard of Care for the Treatment of IDA in an Infusion Center Setting

The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy or to IV iron therapy.

The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy for 28 days or to IV iron therapy.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ≥ 18 years of age and able to give informed consent.
* Iron deficiency is the primary etiology of anemia.
* If using erythropoiesis stimulating agent (ESA), the subject must be using a dose consistent with package insert that has been stable for at least 30 days.
* Doses of potential myelosuppressive medications have been stable for at least 30 days.
* Females at risk of pregnancy must agree to use an acceptable form of birth control and have a negative serum or urine pregnancy test on the first day of dosing.

Exclusion Criteria:

* Hypersensitivity reaction to any component of Injectafer.
* Requires dialysis for treatment of chronic kidney disease (CKD).
* No evidence of iron deficiency.
* During the 10 day period prior to screening has been treated with intravenous iron.
* During the 30 day period prior to screening has been treated with a red red blood cell transfusion.
* Any non-viral infection.
* Known positive hepatitis with evidence of active disease.
* Received an investigational drug within 30 days of screening.
* Alcohol or drug abuse within the past 6 months.
* Hemochromatosis or other iron storage disorders.
* Estimated life expectancy of less than 6 months, or for cancer patients, an ECOG Performance Status greater than 1.
* Pregnant or actively trying to become pregnant (a definitive negative result on a serum or urine pregnancy test performed on the first day of dosing will be required for study enrollment by any women of childbearing potential).
* Any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism

This is a Phase 1b, double-blind (participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with acute submassive pulmonary embolism.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, age 18 to 75 years admitted to hospital with a clinical diagnosis of acute pulmonary embolism (PE) categorized as low risk or intermediate-risk or submassive PE and for whom catheter-based therapy is not planned;
* Subjects must have a computed tomography angiography (CTA) scan confirming the PE diagnosis and with at least one measurable index lesion in a segmental or larger pulmonary artery prior to randomization;
* Subjects should be in otherwise satisfactory health in the opinion of the Investigator;
* Subjects must be able to provide written informed consent.

Exclusion Criteria:

* Subjects with acute PE categorized as high-risk or massive, or who are hemodynamically unstable, evidenced by a heart rate \> 120 /min and a systolic blood pressure (SBP) of \< 90 mmHg for more than 15 consecutive minutes or a drop in SBP of \> 40 mmHg since presentation;
* Subjects for whom use of a thrombolytic, either systemic or via catheter, is planned;
* Subjects with PE lesions only in the sub-segmental or smaller arteries;
* Subjects receiving any vitamin K antagonists (VKAs) prior to randomization or receiving more than 36 hours treatment with low molecular weight (LMW) Heparin in therapeutic doses prior to randomization;
* Subjects who had a prior intracranial hemorrhage, known arteriovenous malformation or aneurysm, head trauma, or evidence of active bleeding;
* Subjects who within 48 hours of randomization have used an anti-Factor IIa agent such as dabigatran or an anti-FXa agent such as rivaroxaban, apixaban, or edoxaban;
* Subjects who within 21 days prior to randomization have had gastrointestinal or genitourinary bleeding;
* Subjects who within 14 days prior to randomization have had major surgery or a lumbar puncture (or epidural steroid injection);
* Subjects with diagnosed active liver disease or with elevation of liver enzymes/bilirubin.
Prognosis Factors in Patients With Primary Central Nervous System Lymphoma

Primary central nervous system lymphoma (PCNSL) is a rare extranodal non-hodgkin's lymphoma confined to the central nervous system. It accounts for about 4% of all intracranial tumors and 4% to 6% of all non-Hodgkin's lymphomas . Among them, the most common type is diffuse large B cell lymphoma (DLBCL), accounting for about 95% of all cases. High dose methotrexate (HD-MTX) based chemotherapy can improve the prognosis of patients, but only 30% to 40% of patients can achieve sustained remission, and the overall prognosis is very poor\[4, 6\]. Currently, the International Extranodal Lymphoma Study Group (IESLG) prognostic scoring system and the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic index are widely used to evaluate the prognosis in patients with PCNSL. However, IESLG model has some limitations such as the relatively small number of patients and short follow-up period. MSKCC model may have an inherent selection bias because retrospective data were collected from a single large institution. Therefore, there is a urgent need to identify novel indicators for prognosis evaluation and risk stratification in PCNSL patients.


Eligibility Criteria:
Inclusion Criteria:

(i)The pathological biopsy and immunohistochemistry diagnosis were PCNSL according to WHO diagnostic criteria for PCNSL in 2016. (ii) No treatment has been received. (iii)There were no diseases with malignant tumor, serious infection, other blood system diseases, immune system diseases and other conditions which may have great influence on peripheral blood lymphocyte count. (iv) The clinical data were complete.

Exclusion Criteria:

-
A Study of the Efficacy and Safety of Vernakalant Hydrochloride (MK-6621) in Patients With Atrial Fibrillation (MK-6621-010 AM4)

This study will investigate if treatment with vernakalant hydrochloride (MK-6621) results in a greater proportion of patients with treatment-induced conversion of Atrial Fibrillation to sinus rhythm compared to placebo.

Amendment 4 of the protocol revised the planned enrollment to 123 participants and removed China as one of the countries participating in the study.

Eligibility Criteria:
Inclusion Criteria:

* Abstinent or willing to use 2 acceptable methods of birth control
* Patient has an atrial arrhythmia with dysrhythmic symptoms
* Patient is receiving adequate anticoagulant therapy
* Patient has stable blood pressure
* Patient weighs between 45 and 136 kg (99 and 300 lbs)
* Patient is adequately hydrated

Exclusion Criteria:

* Patient is pregnant, breast-feeding, or expecting to become pregnant during the study
* Patient routinely consumes more than 2 alcoholic drinks per day
* Patient has known or suspected prolonged QT, familial long QT syndrome, previous Torsades de Pointes, Brugada syndrome
* Patient has known bradycardia, advanced AV block, or sick-sinus syndrome, unless controlled by a pacemaker
* Patient has severe aortic stenosis
* Patient has atrial flutter
* Patient has Class IV congestive heart failure (CHF)
* Patient has had a myocardial infarction (MI) or acute coronary syndrome (ACS)
* Patient has had cardiac surgery within 30 days
* Patient has known atrial thrombus
* Patient has reversible causes of Atrial Fibrillation
* Patient has failed electrical cardioversion during current episode of Atrial Fibrillation
* Patient has uncorrected electrolyte imbalance
* Patient has clinical evidence of digoxin toxicity
* Patient has received certain antiarrhythmic drugs or intravenous amiodarone within 7 days
* Patient is known to be HIV positive
* Patient has a history of cancer within the past 5 years, except for certain skin or cervical cancers
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI)

A three-group parallel randomized controlled trial to evaluate the efficacy of virtual reality analgesia (VRA) to decrease patient procedural pain and anxiety in the Adult patients undergoing Spinal Injections (SI).


Eligibility Criteria:
Inclusion Criteria:

* Adult requiring Spinal Injections
* Adult \> 18years
* Adults with intact vision who can attend VR intervention

Exclusion Criteria:

* Anyone \< 18 years
* Adults who are not attentive to VR secondary to poor concentration, poor cognition to external stimuli
* Adults who request moderate IV sedation
* Adults with photic-induced seizures
Occlusal Reduction Effect on Postendodontic Pain

The aim of this study, thus, was to assess the effect of occlusal reduction on postendodontic pain after the first (post-instrumentation) and the second (post-obturation) visit in mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion treated in two visits.

The purpose of this randomized clinical trial was to evaluate the effect of occlusal reduction on post-instrumentation and post-obturation pain in mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion treated in two visits. Three hundred and eight patients were included in this study. Inclusion criteria were posterior mandibular teeth having symptomatic irreversible pulpitis with sensitivity to percussion. Patients were randomized into two equal groups. In the intervention group, occlusal reduction was done, while, in the control group, the occlusal surfaces were left intact. Conventional endodontic treatment was performed in two visits using a rotary nickel-titanium system followed by the lateral-condensation obturation technique. Post-instrumentation pain was assessed after 6, 12, 24 and 48 hours following the first visit, and post-obturation pain after 6 and 12 hours following the second visit. Each patient received a pain diary to record their pain levels and rescue medication intake.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 18-65 years old.
* The diagnosis of symptomatic irreversible pulpitis with sensitivity to percussion.
* Posterior mandibular teeth.

Exclusion Criteria:

* Pregnant women.
* Patients who reported bruxism or clenching.
* Patients who took analgesics during the last 12 hours before treatment start.
* Teeth with no occlusal contact.
* Unrestorable teeth.
Transversalis Fascia Plane Block for Iliac Bone Graft in Children

The purpose of this study is to determine which method is more effective in postoperative pain control in children undergoing iliac bone grafting for alveoloplasty under general anesthesia: ultrasound-guided transverse abdominal blockade or transversalis fascia plane block


Eligibility Criteria:
Inclusion Criteria:

* Children aged 7 years and older but under 18 undergoing iliac bone grafting for alveoloplasty

Exclusion Criteria:

* Patients with diseases that affect pain sensitivity differently from the general population (e.g., congenital insensitivity to pain with anhidrosis, complex regional pain syndrome, etc.)
* Cases where there is difficulty in expressing pain (due to cognitive or functional deficits, or limited ability to communicate)
* Unstable vital signs (heart rate, blood pressure)
* Common contraindications for Ropivacaine: 1) Patients with a history of hypersensitivity to this drug or other amide local anesthetics, 2) Patients in a state of major bleeding or shock, 3) Patients with inflammation at or around the site of administration, 4) Patients with sepsis, 5) Intravenous regional anesthesia (Bier block)
* History of allergy to opioid medications
* Severe renal impairment (Creatinine \>3.0mg/dL)
* Severe liver function abnormalities (aspartate transaminase \> 120 unit/L, alanine aminotransferase \> 120 unit/L)
* Peripheral nervous system disorders
* Other cases deemed unsuitable by the researcher
Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries

The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-world population of 209 patients who underwent an endovascular intervention within standard-of-care of the iliacofemoral artery and renal artery, using at least one of the investigational products from iVascular.


Eligibility Criteria:
Inclusion Criteria:

* Corresponding to the CE-mark indications/contra-indications and according to the IFU of the device.
* Patient is \>18 years old.
* Patient understands the nature of the procedure and provides written informed consent prior to enrollment in the study.
* Target lesion(s) is/are located in renal, iliac or femoral arteries.
* Patient is eligible for treatment with the Oceanus 18 Balloon Dilatation Catheter and/or the Oceanus 35 Balloon Dilatation Catheter and/or the Luminor 18 Drug Coated Balloon and/or the Luminor 35 Drug Coated Balloon and/or the Restorer Peripheral Stent System and/or the iVolution pro Peripheral Self-Expanding Stent System and/or the iCover Covered Peripheral Stent System and/or the Sergeant Peripheral Support Catheter as described in IFU for each device.

Exclusion Criteria:

* Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices.
* Known contraindication and/or allergy to (a component of) an investigational device.
* Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding.
* Life expectancy of less than 12 months.
* Any planned surgical intervention/procedure within 30 days after the study procedure.
* Any patient considered to be hemodynamically unstable at onset of the procedure.
Comparison in Difficult Airway Scenario Induced in Patients With Laryngeal Mask Airway (LMA)-Classic™, LMA™ - Flexible and LMA - Proseal™

Supraglottic airway tools, one of the tools used in the management of the difficult airway. American Society of Anesthesiologists and the Difficult Airway Society of the United Kingdom airway management algorithms have included the LMA. In our study investigators aimed to determine which one will show the best performance with supraglottic airway means that LMA - Classic, LMA - Flexible and LMA - ProSeal in patients that difficult airway scenarios created with attaching collar.


Eligibility Criteria:
Inclusion Criteria:

* Without a history of difficult intubation, supine position, does not require tracheal intubation, undergo elective surgery

Exclusion Criteria:

* High aspiration risk, who take more than 4 hours surgery
* Body mass index greater than of 35 kg/m²
* Disease related to the cervical spine
* The mouth opening is less than 20 mm
Assessing Health-Related Quality of Life and Willingness to Pay for Weight Management in Asia-Pacific by Gender

The purpose of this survey is to collect information for scientific research and to identify the impact of overweight and obesity on health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age above or equal to 18 years at the time of signing informed consent.
3. Not currently pregnant
4. Does not participate in intense fitness or body building program
5. Weight loss not through illness or injury
6. Lives in South Korea, Australia, or India
7. BMI above or equal to 18 and associated weight class (Normal Weight or above) will be determined by a programmed calculation based on participant-reported height and weight.

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
3. Does not meet inclusion criteria.
Pediatric Obesity Weight Evaluation Registry (POWER) Study

The main objective of this study is to establish a national pediatric obesity registry known as POWER (Pediatric Obesity Weight Evaluation Registry). This registry will contain clinical data from individual comprehensive pediatric weight management programs around the United States for overweight and obese youth.

All patients 18 years of age or younger who have completed an initial medical assessment between March 1, 2014 through April 30, 2020 will be approached for this study.

Data from individual follow up visits or group intervention sessions, depending on the program design of each institution, will be collected through October 31, 2020. The data included in this study will be collected during routine medical care. Information that could identify a participant will be removed from the data. Data will be entered into a secure database called Medidata Rave® CDMS. This database will be managed by the Data Coordinating Center (DCC) at Cincinnati Children's Hospital Medical Center (CCHMC).

The DCC will combine all the data from each site. Additional data cleaning and data quality monitoring will be performed. Combined datasets for analysis will be provided by the DCC in a format agreed upon by the POWER Governance Board. Data will be stored in a secure and protected format and will not include any written or electronic protected health information (PHI/EPHI). The DCC will store the data on a secure server.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or younger
* overweight or obese patient
* initial medical evaluation in a pediatric weight management program between March 1, 2014-April 30, 2020.

Exclusion Criteria:

* no exclusion criteria
Nimotuzumab Plus Nab-paclitaxel and Cisplatin in Treating Patients With Advanced Esophageal Carcinoma

There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is advantageous for advanced esophageal cancer patients in combination with chemotherapy or radiotherapy.And,albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy,and with greater concentration in tumor tissue compared with normal tissues.So,The objective of this single-arm phase II trial was to evaluate the benefit of nimotuzumab plus nab-paclitaxel and cisplatin in patients with advanced esophageal carcinoma.

In the past decade, clinical trials have evaluated the role of chemotherapy, radiation, or both, for patients with advanced esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, Chemotherapy became one of the treatment strategies for advanced esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, the investigators conducted a prospective study to evaluate the regimen of Nimotuzumab plus Nab-paclitaxel/cisplatin for patients with advanced esophageal squamous cell carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Patient who was confirmed stage IV esophageal carcinoma by pathologic histology or cytology.
* Males or females aged ≥18 years, \< 75 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Life expectancy ≥12 weeks.
* Adequate bone marrow, renal, and liver function are required.
* Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

Exclusion Criteria:

* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
* Allergy to anti-EGFR antibody.
* Female subjects should not be pregnant or breast-feeding.
* Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function: total bilirubin \< 1.5 x upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases.
* Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Omics in Valvular Disease

The aim of our study is to investigate the effects of impaired left ventricular remodeling on the short- and long-term prognosis in AS partecipants undergoing extracorporeal circulation during valve repair surgery and in partecipants undergoing implantation transcatheter. For the achievement of these purposes, markers obtained from will be considered cardiovascular imaging methods, such as color Doppler echocardiography and isolated biomarkers from peripheral blood and heart tissue.

Participation in this study includes, following enrollment, a visit of follow up (6/12 months) on the occasion of a concomitant medical check-up scheduled according to normal clinical practice. During these visits venous and contextual blood samples will be taken echocardiographic examination for re-evaluation of ejection fraction, as per normal practice clinic. The only variant will be the withdrawal of an additional aliquot of blood during the sampling standard blood.

All enrolled partecipants will undergo the optimal medical treatment provided by current and more recent guidelines for the treatment of heart valve disease. Joining this study will not result any modification of the current therapy, which will be established by the attending physician according to the correct one clinical practice.

Eligibility Criteria:
Inclusion Criteria:

-30 patients with a diagnosis of severe aortic stenosis and preserved ejection fraction to echocardiographic evaluation

Exclusion Criteria:

* inflammatory;
* infectious diseases;
* neoplasms;
* ailments immunological or haematological;
* treatment with anti-inflammatory drugs except aspirin a low dose (75-160 mg);
* age \> 85 years;
* advanced chronic kidney disease with filtrate glomerular heart rate (eGFR) estimated by MDRD equation \<30 ml/min./1.73 m2.