cyrilzakka/clinical-trials huggingface dataset:
Assess Safety & Efficacy of Selumetinib When Given in Combination With Standard First Line Treatment for Advanced Non-small Cell Lung Cancer

This is a Phase I, open label multicentre study of selumetinib administered orally in combination with first line chemotherapy regimens to patients with advanced/metastatic NSCLC. The study has been designed to allow an investigation of the optimal dose of selumetinib in combination with various standard first line double-platinum chemotherapy regimens. Initial assessment will be based on tolerability of selumetinib in combination with one or more selected regimens that are considered to be tolerated also being assessed for preliminary evidence of activity.

This study is a dose finding and optional cohort expansion; In addition all patients will be assessed for anti-cancer efficacy of the combination of selumetinib and chemotherapy.

A Phase I, Open Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Selumetinib (AZD6244; ARRY-142886) in Combination with First Line Chemotherapy Regimens in Patients with Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written and dated consent prior to any study specific procedures
* Male or female, aged 18 years or older
* Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
* Female patients must not be breast-feeding and have a negative pregnancy test prior to start of dosing or must have evidence of non-child-bearing potential
* Patients must be eligible to receive treatment with the platinum doublet combination with which selumetinib is being combined and in accordance with the local product information

Exclusion Criteria:

* Prior chemotherapy or other systemic anti-cancer treatment for advanced NSCLC.
* Prior surgery or radiotherapy within 6 months or palliative radiotherapy within 4 weeks of start of study treatment.
* Female patients who are breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
* Another primary malignancy within 5 years of starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ.
* As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, active bleeding diatheses, renal transplant, or active infection
Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.

OBJECTIVES:

* Determine the complete remission rate (CR).
* Determine the proportion of patients who are bone marrow-positive at day 7 post-induction chemotherapy.
* Further evaluate the toxicity of this regimen.

OUTLINE: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with \> 25% cellular biopsy or \> 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Inclusion criteria:

* Newly diagnosed acute myeloid leukemia (AML)

  * Morphologic proof (bone marrow aspirate smears or touch prep of marrow biopsy) of disease
  * FAB M0, M1, M2, M4, M5a, M5b, M6a, M6b, and M7 disease
* Previously untreated with radiotherapy or chemotherapy

  * Patients with treatment-related leukemia are eligible even if they have received prior chemotherapy and radiotherapy
* Patients with prior myelodysplastic syndrome are eligible
* Extramedullary leukemia allowed
* AML with lymphoid markers allowed

Exclusion criteria:

* Blastic transformation of chronic myelogenous leukemia
* Biphenotypic leukemia
* FAB M3 disease (acute promyelocytic leukemia)

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 6 weeks
* Total bilirubin \< 1.5 g/dL
* AST and ALT \< 5 times upper limit of normal (ULN)
* Creatinine \< 1.5 mg/dL OR creatinine clearance \> 70 mL/min
* Ejection fraction ≥ 50% by MUGA unless decreased ejection fraction is secondary to leukemia infiltration
* HIV antibody-negative

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

* See Disease Characteristics
* Prior hydroxyurea or corticosteroids allowed
* At least 48 hours since prior and no concurrent itraconazole or fluconazole

Exclusion criteria:

* More than 300 mg/m² of prior daunorubicin or equivalent dose of anthracycline
Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair

The goal of this retrospective study is to identify the incidence of hernia recurrence following the application of Histoacryl® Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery. All adult patients who underwent laparoscopic inguinal hernia repair with Histoacryl® Lapfix - Cannula in the period June 2018 - March 2021 at Hospital San Juan de Dios will be analysed. The investigator team will access electronical medical records for the cohort of patients identified.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years old)
* treated between June 2018 and March 2021 at the Hospital San Juan de Dios for laparoscopic mesh fixation with Histoacryl Lapfix - Cannula after inguinal hernia repair surgery.

Exclusion Criteria:

* No exclusion criteria has been set.
Neo-adjuvant Chemotherapy Evluation in Gastric Cancer Patients Based on Circulating Exosomal LncRNA-GC1

The investigators hope that through the analysis and research to find determine whether lncRNA-GC1 could serve as a non-invasive biomarker for monitoring the neo-adjuvant chemotherapy response for personalized medicine for gastric cancer.

The LncRNA-GC1could noninvasively track dynamics of tumor burden and has been proposed as a real-time biomarker that can provide both predictive and prognostic values. But the value in monitoring the neo-adjuvant chemotherapy response is unclear. The investigators hope that through the analysis and research to find determine whether lncRNA-GC1 could serve as a monitoring biomarker for patients with gastric cancer receiving neo-adjuvant chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Having signed informed consent
* Age≥ 18 years old
* Histologically confirmed gastric adenocarcinoma
* radiographically identified as advanced gastric cancer

Exclusion Criteria:

* Other previous malignancy within 5 year
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study
* Pregnancy or lactation period
* Legal incapacity
Comparison of Anthropometric Parameters and Cardiometabolic Risk Factors Among Subjects With Overweight and Obesity

The study was aimed at comparing four different anthropometric parameters to cardiometabolic risk factors in overweight and obese subjects (Body Mass Index (BMI)≥25)

the present study was focused to compare the level of statistical association among four different anthropometric parameters, body mass index (BMI), waist circumference (WC), waist to height ratio (WHtR) and neck circumference (NC) and the cardiovascular (CV) risk factors most commonly evaluated in the clinical practice such as systolic and diastolic blood pressure, and fasting glucose, lipid (triglycerides, total, High-density lipoprotein (HDL) and Low-density lipoprotein (LDL) cholesterol), insulin, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), uric acid, 25-hydroxyvitamin D (25(OH)D), c-reactive protein (CRP), white blood cells and platelet number in a population of 1214 apparently healthy subjects with overweight and obesity subjects

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obesity (BMI\> 25 Kg/m2)

Exclusion Criteria:

* Any kind of drug
* Hypertension
* Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
* Chronic inflammatory diseases
* Renal failure
* Liver failure
* Angina pectoris
* Myocardial infarction and heart failure
* Genetic heart diseases
* Thrombocytopenias
Analgesic Effect of Different Positions and Canulae on Medial Branch Radiofrequency Denervation for Lumbar Zygapophyseal Joint Pain

Prospective study to analyse pain reduction with two types of canulae and two types of placements for lumbar medial branch radiofrequency denervation.

Patients who suffer from lumbar zygapophyseal joint pain often receive radiofrequency medial branch denervation as treatment. Many types if canulae exist, and many types of placing them in relation to the Medial Branch nerves (MB). The EARL study tries to compare the analgesic effect of thin canulae (22 gauge) placed perpendicular to MB to thicker canulae (18 gauge) placed parallel to MB.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain of \> 3 months
* 18-80 years
* VAS or NRS\>6
* Positive controlled block

Exclusion Criteria:

* Pregnancy
* Psichiatric disorders
* Not being able to fulfil questionnaires
* Body Mass Index\>35
* Labor Litigation
* Negative or non conclusive controlled block
* Failed Back Surgery Syndrome
Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography

This proposal is based on findings from our previous work involving ferumoxytol-enhanced cardiac magnetic resonance angiography. The resolution of the pulmonary vasculature based on our previous imaging protocol was exceptional (PMID: 26786296). In the Partners Healthcare System between January 1, 2014 and January 1, 2015 there were 541 patients evaluated in Partners Healthcare-affiliated hospitals with a diagnosis of pulmonary embolism and acute or chronic kidney disease at the same visit between 01/01/2014 and 01/01/2015. Ventilation perfusion scanning was performed in 201 patients during this same time interval. Up to 63% of these patients in one year did not receive the diagnostic test of choice.

Thromboembolic events in patients with chronic kidney disease are out of proportion to age matched controls occurring 2.34 times more frequently than in non-CKD patients (PMID 19561505). At the same time, patients with kidney disease are not offered the gold standard for pulmonary embolus diagnosis, i.e. CT angiography, for concern of acute dialysis to treat contrast-induced nephropathy. Ventilation perfusion scintigraphy (V/Q) is the preferred diagnostic test for patients with advanced CKD (glomerular filtration rate \<30mL/min/m2) and suspicion of pulmonary embolus, but can not be utilized if pulmonary parenchyma contains interstitial edema or alveolar occlusion due to pneumonia. If diagnostic tools for pulmonary embolus are not available, patients are subject to the risk of empiric treatment to avoid life-threatening complications of untreated pulmonary embolus. For those patients with CKD that undergo CT angiography, they are placed at risk of initiating dialysis. If this occurs multiple financial costs are associated with dialysis catheter placement and acute hemodialysis. If a patient instead is evaluated with gadolinium-based contrast modalities, there is the risk of nephrogenic systemic fibrosis and the morbidity associated with this iatrogenic disease process.

Ferumoxytol-enhanced MRI could avoid the risk of iodinated contrast and gadolinium contrast and accelerate the diagnosis and treatment of patients with pulmonary embolus.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical suspicion for pulmonary embolus
* estimated glomerular filtration rate (eGFR) \<30mL/min/1.73m2
* have been clinically disqualified from the use of iodine-based contrast studies, gadolinium-based contrast studies or nuclear-based detection studies

Exclusion Criteria:

* received ferumoxytol in the previous six months
* anaphylactic reaction to other intravenous iron formulations
* calculated estimated glomerular filtration rate is \>50mL/min/1.78m2
* patients on dialysis with no residual renal function
* pregnant women and nursing mothers. Standard screening will be used by
* patients \>65 years of age with BMI \>45, and/or liver disease (Child-Pugh class C)
Drug Allergy Labels After Drug Allergy Investigation

The aim of this study is to investigate the degree of match between the drug allergy label in the hospital's electronic health record and primary care's electronic health record among patients who previously have been drug allergy tested.

Patients who previously have been penicillin allergy tested in 2017 to 2019 at the Allergy Clinic at Gentofte Hospital is included in the study. Patients are identified through a drug allergy database at the department.

A letter describing the study and the data collection process will be sent to the patients' General Practice offices (GP).

Data collection: The patients GP's are contacted by telephone where the information about the drug allergy labels in their electronical medical charts are shared. On the same day as the phone contact to the GP's office, the patient's electronical health record in the hospital system is accessed in order to gain information about the current drug allergy registrations.

Predictors for the explanatory analysis is collected partly through the phone call to the GP (such as numbers of patients and physicians at each GP and the electronic health system used), from the hospital electronic health record (such as number of hospital admissions since drug allergy testing) and from the drug allergy database.

Eligibility Criteria:
Inclusion Criteria:

* Penicillin allergy tested at the Allergy Clinic, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark in 2017-2019

Exclusion Criteria:

-
SHR-1701 in Patients With Recurrent/Metastatic Scchn

This is an open label, single-arm, multi-center, phase II study of SHR-1701 in patients with recurrent/metastatic SCCHN


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed Recurrent/Metastatic SCCHN,not include NPC
2. Subjects failure after 1 lines of platinum based chemotherapy or failure from anti-PD-1/PD-L1 antibody therapy.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry.
4. Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
5. Adequate hematological, hepatic and renal function as defined in the protocol Other protocol-defined inclusion criteria could apply.

Exclusion Criteria:

1. Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor.
2. Anticancer treatment within 28 days before the first dose of study drug.
3. Major surgery within 28 days before start of trial treatment.
4. Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment.
5. With any active autoimmune disease or history of autoimmune disease.
6. History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy.
Ultraviolet Light Therapy for Systemic Lupus Erythematosus

OBJECTIVES:

I. Evaluate the mechanisms of ultraviolet A-1 light therapy in patients with systemic lupus erythematosus and normal controls.

PROTOCOL OUTLINE:

Treatment with ultraviolet A-1 light is administered 5 days a week for 6 weeks, at the lowest dose or frequency required to maintain a response. The dose and frequency are progressively decreased over the next 9 weeks.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Patients ages 15 to 70 with symptomatic systemic lupus erythematosus meeting American Rheumatism Association criteria and normal controls

--Prior/Concurrent Therapy--

No requirement for tetracycline or other photosensitizing drugs
Lung-protective Ventilation During Robot-assisted Laparoscopic Radical Cystectomy

Robot-assisted laparoscopic radical cystectomy (RARC) increases the incidence of postoperative complications. We conducted a study to determine the effect of lung-protective ventilation strategy.

Robot-assisted laparoscopic radical cystectomy (RARC) performed with patient in the steep Trendelenburg position under pneumoperitoneum increases the incidence of postoperative complications. Approach termed lung-protective ventilation (LPV) strategy which refers to the use of low tidal volumes and positive end-expiratory pressure (PEEP) may lead to a reduction in inflammation and prevent the occurrence of atelectasis. Computed tomography (CT) requiring transportation is the golden standard for measuring atelectasis, which is not suitable for perioperative observation. Lung ultrasound (LUS) which is noninvasive and easily repeatable at the bedside appears to be an accurate diagnostic tool for early detection of atelectasis. Thus, we conducted the trial to determine whether an LPV strategy has benefits in patients scheduled for RARC through a multifaceted method. We hypothesized that the use of prophylactic low tidal volume and PEEP would decrease postoperative inflammation and atelectasis, thereby, improve outcomes, as compared with the standard of nonprotective mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective RARC

Exclusion Criteria:

* history of lung surgery
* patients' refusal or inability to give informed consent
Autonomic Evaluation of Patients With Hereditary Amyloidotic Cardiomyopathy: Hereditary Amyloidotic Heart Disease

Transthyretin amyloidosis exhibits a variety of possible phenotypes, the hereditary neurological form being the most commonly found and studied (familial amyloidotic polyneuropathy or FAP), which can present from oligosymptomatic patients to patients with peripheral sensorimotor polyneuropathy of varying degrees and dysautonomia.

Although a specific mutation usually causes a specific phenotype, that is, with a predominantly cardiac or preferential neurological profile, with the increase in the number of diagnosed cases, an overlapping of clinical presentations has been observed.

The assessment of the autonomic profile in individuals with familial amyloidotic cardiomyopathy (FAC) has not been well studied, and it is not known whether patients with an exclusively cardiac profile of the disease may present dysautonomia or whether even mutation carriers without cardiac involvement may exhibit it.

In this study, the autonomic profiles of patients with familial amyloidotic heart disease will be compared with the profiles of patients who have mutations but without established heart disease and healthy individuals (control group).


Eligibility Criteria:
Inclusion Criteria:

* FAC group: patients with familial familial amyloidotic cardiomyopathy (FAC).
* Non-FAC group: patients with transthyretin gene mutations who do not have FAC.
* Control group: healthy, asymptomatic individuals without comorbidities and without transthyretin gene mutations.
* Agreement and signing the informed consent form.

Exclusion Criteria:

-
Efficacy and Security of Intrapleurally Alteplase vs Urokinase for the Treatment of Complicated Parapneumonic Effusion and Empyema

1. Objectives:

   * Main objective: To evaluate the efficacy and safety of intrapleural alteplase vs urokinase in patients with complex complicated parapneumonic pleural effusion and empyema.
   * To evaluate the pleural and plasmatic levels of the fibrinolytic system markers after the treatment with alteplase vs urokinase
   * To evaluate the safety of alteplase in the treatment of complex complicated parapneumonic pleural effusion and empyema
2. Design: Multicentric, randomized, parallel, controlled and double blind
3. Main variable: Percentage of curation
4. Study population and number of patients: 204 patients with complex complicated parapneumonic pleural effusions and empyema
5. Duration of the treatment: Three days (main variable), and optional three days (secondary variable)


Eligibility Criteria:
Inclusion Criteria:

* Empyema and Complex Complicated Parapneumonic Pleural Effusion

Exclusion Criteria:

* Pregnancy or breastfeeding
* Critically illness
* Systemic anticoagulant treatment
* Coagulation Disorder
* Bronchopleural fistula
* Active bleeding
* Recent punction of noncompressive artery
* Stroke in the last 6 months
* Major intervention o major traumatism in the last 6 weeks
* Hypersensibility to urokinase or alteplase
* Severe Liver or kidney failure
* Inclusion in another interventional study in the last month
The Effects of Weighted Waist-Hooping

Purposes: 1) To determine the effects of weighted waist-hooping on balance in healthy individuals and 2) to observe whether these effects are attributed to neuromuscular conditioning or core strength gains.

Methods: 27 females (ages 20-45) were included, 15 in the intervention group, and 12 in the control. The intervention consisted of six weeks of weighted waist-hooping four times a week for 10 minutes each session. Balance was assessed pre and post intervention using the BESS, SEBT, and Neurocom SOT. Core strength was assessed using hold duration of a bilateral and unilateral plank.


Eligibility Criteria:
Inclusion Criteria:

* healthy women age 18-45.

Exclusion Criteria:

* pregnancy and vertigo
Single Cell Sequencing of Tonsillar Tissue in Children With OSA

Obstructive sleep apnoea (OSA) in children is a prevalent sleep disorder, and is characterised by repetitive complete or partial upper airway obstruction during sleep. It is an important disease as it is associated with a large spectrum of end-organ morbidities.

Adenotonsillar hypertrophy is the commonest cause of OSA in children, however, the cause of the lymphoid tissue hypertrophy in some individuals but not the others remains unknown. To address the cellular heterogeneity and immune cell involvement in adenotonsillar hypertrophy, here, we propose to employ single-cell sequencing analysis to identify the cell-specific expression patterns associated with the disease, which will enhance our understanding of the pathogenesis of tonsillar hypertrophy in children with OSA and may provide directions for development of novel therapy.


Eligibility Criteria:
Inclusion Criteria:

Case: Chinese children aged 6-11 years old with habitual snoring (≥3 nights per week) and polysomnography (PSG) confirmed OSA (obstructive apnoea hypopnoea index (OAHI) of ≥1/hour), with adenotonsillar hypertrophy and clinical indications for adenotonsillectomy will be recruited as cases.

Control: Non-OSA subjects (with PSG OAHI \<1/hour) who undergo adenotonsillectomy for other reasons such as recurrent tonsillitis.

Exclusion Criteria:

Previous upper airway surgery, genetic or syndromal disease, congenital or acquired neuromuscular disease, congenital or acquired immunodeficiency, known metabolic syndrome, craniofacial abnormalities.