cyrilzakka/clinical-trials huggingface dataset:
Dexamethasone Versus Nalbuphine as Adjuvants in Brachial Plexus Block

Brachial plexus block is a very reliable method of regional anesthesia for the upper limb. It achieves ideal operating conditions by producing complete muscular relaxation and stable intraoperative hemodynamics.However,Local anesthetics alone have a shorter duration of postoperative analgesia. Hence,various adjuvants have been added to local anesthetics to achieve quick, dense, and prolonged block. This study assess and compare the efficacy of dexamethasone or nalbuphine as adjuvants to local anesthetics in supraclavicular brachial plexus block for upper limb surgeries.

Upper-limb surgeries can be performed under either general or regional anesthesia.However, regional anesthesia has the advantages of long-lasting pain relief \& avoidance of airway instrumentation.Brachial plexus block is a very reliable method of regional anesthesia for the upper limb. It achieves ideal operating conditions by producing complete muscular relaxation and stable intraoperative hemodynamics.However,Local anesthetics alone have a shorter duration of postoperative analgesia. Hence,various adjuvants have been added to local anesthetics to achieve quick, dense, and prolonged block. This study assess and compare the efficacy of using 8 mg dexamethasone or 10 mg nalbuphine as adjuvants to local anesthetics mixture (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) in Ultrasound-guided supraclavicular brachial plexus block for upper limb surgeries below the level of the shoulder.

Eligibility Criteria:
Inclusion Criteria:

* Patient acceptance.
* American Society of Anesthesiologists (ASA) I and (ASA) II.
* Age 21-60 years old.
* Both gender.
* BMI \< 30.
* Accepted mental state of the patient.
* Unilateral upper limb surgeries below the level of the shoulder.

Exclusion Criteria:

* Patient refusal.
* Peripheral neuropathy.
* Pathological coagulopathy.
* Infection at the injection site.
* History of active substance abuse.
* Untreated pneumothorax.
* Disturbed conscious level.
* An allergy to local anesthetics or nalbuphine or dexamethasone.
* Planned for receiving general anesthesia during the same operation for any cause.
Remission Clinic in Proteinuric Chronic Nephropathies

Most chronic kidney diseases have a progressive evolution characterized by the gradual loss of glomerular filtration rate (GFR), electrolytic imbalance, reduced erythropoietin synthesis and activation of vitamin D. On many occasions, the progressive deterioration of renal function occurs, even when the etiologic factors responsible for the kidney disease are treated and/or eliminated as a result of an auto-sustained mechanism of inflammation and fibrosis. Moreover, chronic nephropathies are often associated with high blood pressure and increased urine protein excretion, being both risk factors of progression toward kidney failure. Many clinical studies have shown the efficacy of antihypertensive therapies, particularly the blockade of renin-angiotensin system, to lower the abnormal urinary protein excretion. Moreover, control of blood pressure and proteinuria slow the rate of renal function decline and in some cases even lead to recovery of kidney function avoiding the need for renal replacement therapies. The set of measures to achieve these results encompasses the term of "renoprotective therapy". However these achievements have been obtained in the setting of clinical trials, and need confirmation in the daily clinical practice.

To this purpose a standardized multidrug intervention model that aims at normalizing the excretion of urinary proteins and stabilizing the renal function has been developed for the outpatient-clinic and named "Remission Clinic".

The applicability of this protocol is aimed for all nephrology and diabetology centers. Through the use of a dedicated database computer network, it will be possible to share clinical, laboratory and treatment data, recorded for each patient enrolled in the Remission Clinic program. With this system, it will be possible to verify if the multidrug approach of the Remission Clinic will allow to improve the clinical course of chronic proteinuric nephropathy. All participants (centers) may access to the Remission Clinic website developed, updated and maintained by the Department of Bioengineering of the Mario Negri Institute, Bergamo, Italy.


Eligibility Criteria:
Inclusion Criteria:

* Proteinuria \>0.5 g/24 hours or albuminuria \>200 g / min (or \>300 g/24 hours) for at least 2 consecutive evaluations regardless of treatment with ACEi and/or ARBs;
* Change in serum creatinine or creatinine clearance less than 30% in the last 3 months;
* No corticosteroids or immunosuppressants at the time of inclusion or given to patient in the last 6 months.

Exclusion Criteria:

* Idiopathic membranous nephropathy;
* Focal segmental glomerulosclerosis;
* Minimal change glomerulopathy;
* Nephritic syndrome;
* Rapidly progressive renal failure (extracapillary glomerulonephritis in active phase);
* Any active renal disease that represents a possible indication to corticosteroids or immunosuppressive therapy;
* Nephropathies secondary to systemic disease susceptible to treatment with corticosteroids or immunosuppressive agents (Systemic Lupus Erythematosus, Vasculitis, Amyloidosis, etc.).
Beovu Experience UZ Leuven

Reporting early real-world clinical data of consecutive patients on the use of Beovu® (brolucizumab) intravitreal injections in patients with neovascular age-related macular degeneration.

Brolucizumab (Beovu, Novartis, Basel, Switzerland) is the newest anti-vascular endothelial growth factor (anti-VEGF) drug. It received FDA approval for the treatment of neovascular age-related macular degeneration (nAMD) in October 2019 followed by EMA approval in February 2020. Brolucizumab received marketing approval based on the two pivotal phase 3 clinical trials - HAWK and HARRIER - with a q8/q12 week dosing regimen. Potential benefits of brolucizumab are assumed to be related to its low molecular weight with subsequent better tissue penetration as well as higher molar concentration. This could improve the treatment durability and lower the burden for patients and caregivers when dealing with repetitive intravitreal treatments and monitoring visits over a long period of time in a chronic disease. However, safety signals have been reported in both RCTs and post-marketing reports, which included the occurrence of intraocular inflammation (IOI) and retinal vasculitis with or without occlusion.

In this study we want to share our early results and experience with Bolucizumab in UZ Leuven. By retrospective analysis of a cohort of 17 patients treated with Brolucizumab, we evaluate the efficacy of the drug as well as the occurrence of adverse-events, especially intra-ocular inflammation and vasculitis.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of neovascular age-related macular degeneration
2. Partial response on current anti-VEGF treatment or unability to prolong the treatment interval beyond 6 or 8 weeks

Exclusion Criteria:

* 1. Any form of previous intraocular inflammation 2. Any form of previous inflammatory reaction after anti-VEGF treatment 3. Functionally monophthalmic patients 4. Any sign of active intraocular inflammation
Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma

Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.


Eligibility Criteria:
Inclusion Criteria:

Patients who met the following criteria were included:

* Males or females of any race, who were 12-75 years of age
* A body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700 IU/ml
* A diagnosis of allergic asthma ≥ 1 year duration according to American Thoracic Society (ATS) criteria and at screening a history consistent with GINA (2204) step 3 or 4 clinical features
* A positive prick skin test (diameter of wheal \>= 3 mm) to at least one perennial allergen documented within the past 2 years or taken at visit 1
* Increase in FEV1 ≥12% over baseline value within 30 minutes of taking 2 to 4 puffs (2-4x100µg) salbutamol (albuterol) or nebulized salbutamol up to 5mg
* An FEV1 ≥ 40 and ≤ 80% of the predicted normal value for the patient at randomization
* Receiving moderate to high dose inhaled corticosteroid ≥ 800 µg BDP or equivalent and a regular inhaled long acting B-2 agonists for at least 3 months prior to screening and \> 1000 µg (BDP) and a LABA for at least 4 weeks during the run-in and at randomization
* Patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations while receiving high doses of ICS (≥ 800 µg BDP or equivalent) plus regular inhaled LABA
* Evidence of poor asthma control at screening (based on patient history) and for at least 4 weeks immediately prior to randomisation

Exclusion Criteria:

Patients who met the following criteria were excluded:

* Had received systemic corticosteroids for reasons other than asthma within 4 weeks of Visit 1
* A smoking history \>10 pack years
* An active lung disease other than allergic asthma
* Elevated serum IgE levels for reasons other than allergy
* Patients with significant underlying medical conditions
Irinotecan Plus S1 Versus S1 in Patients With Previously Treated Advanced Esophageal Cancer: ESWN 01 Trial

Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.

The purpose of this study is to evaluate the progression free survival and safety of irinotecan plus S1 versus S1 alone in the patients with previously treated advanced esophageal cancer

Two arms, phase 3 study of irinotecan plus S1 versus S1 alone in previously treated patients with recurrent or metastatic esophageal cancer. 240 Patients will be enrolled in this trial. The primary objective of this study is to determine the PFS of the two arms. One arm is as follows: irinotecan 160 mg/m2 will be administered as an intravenous infusion over 60 minutes on Days 1, followed by S1 80mg to 120 mg per day on Days 1-10, every 14 days per cycle. The other arm is S1 80mg to 120 mg per day on Days 1-14, every 21 days per cycle.This study will also include the investigation of UGT1A1polymorphisms in the study population.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven esophageal squamous cell carcinoma;
* 18 ≤ age ≤ 70;
* ECOG 0-2;
* Previously Treated with platinum or paclitaxel based regimen;
* Uni-dimensionally measurable disease (CT or MRI as per RECIST);
* Patients should have a projected life expectancy of at least 3 months;
* Completion of baseline quality of life questionnaire
* Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl);
* Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
* liver functions (serum bilirubin ≤ 1.5UNL, AST/ALT ≤ 3 times(normal value)
* Written informed consent

Exclusion Criteria:

* Previous chemotherapy with 5-FU or irinotecan after recurrence or metastasis;
* adjuvant chemotherapy with 5-FU-based chemotherapy within 6 months prior to the start of study treatment;
* Active infection requiring antibiotics
* Pregnant, lactating women
* Psychiatric illness, epileptic disorders
* Concurrent systemic illness not appropriate for chemotherapy
* History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma
Clinical Trial of Lupeol for Mild-moderate Acne

For the chemical lupeol isolated from eggplant, we applied it to one side of face, and applied vehicle control to another side for 8 -weeks. The study was performed in a 8-week, randomized controlled, split face fashion. Investigators evaluated safety and efficacy during baseline, 2 weeks, 4weeks, and 8 weeks after beginning of study.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age 15 who were clinically diagnosed with mild to moderate acne vulgaris

Exclusion Criteria:

* ; known pregnancy or lactation, any medical illness that might influence the results of the study, a previous history of oral acne medication or surgical procedures including laser treatment within 6 month and topical medication within 4 weeks of study enrollment.
Austrian Registry for Evaluation of Treatment Patterns and Outcome in Patients with Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

To systematically collect and analyse real-world data on treatment patterns, clinical outcomes and toxicities among patients with advanced pancreatic ductal adenocarcinoma (PDAC) undergoing systematic treatment in Austria

1000 adult patients with locally advanced inoperable and/or metastasized PDAC undergoing first line chemotherapy

Eligibility Criteria:
Inclusion Criteria:

* 18 years, female and male
* ECOG (Eastern Cooperative Oncology Group) Scale 0-2
* Diagnosis of histologically confirmed locally advanced inoperable and/or metastatic PDAC
* Patients undergoing palliative 1st line therapy with a platinum- or gemcitabine- based chemotherapy in case of previous (neo)adjuvant therapy also patients who receive nal-Irinotecan/5-FU/Leukovorin as palliative first line are eglible
* Signed informed consent for prospective patients, for retrospective cases no informed consent is required

Exclusion Criteria:

* Patients with locally advanced operable PDAC who do not receive palliative chemotherapy
* Patients with locally advanced borderline resectable PDAC who do not receive palliative chemotherapy
A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children

The purpose of this study is to evaluate the safety profile of voriconazole (an antifungal drug) when used in children who have invasive aspergillosis (IA) and other rare systemic fungal infections.


Eligibility Criteria:
Inclusion Criteria:

* Immunocompromised with clinically compatible illness.
* Diagnosis of proven or probable or possible Invasive Aspergillosis (based on a modified version of the revised EORTC/MSG consensus definitions).
* Diagnosis of infection due to Scedosporium or Fusarium species.
* Male and female from 2 to 17 years of age.
* Females with childbearing potential must have negative pregnancy test and be using appropriate contraception.

Exclusion Criteria:

* Allergy or hypersensitivity to the azole drugs.
* Female subjects who are pregnant or lactating.
* Patients who received more than four days of antifungal drugs to treat the current episode of invasive aspergillosis or rare mold infection.
* Received within 24 hours prior to enrollment drugs that may cause QT interval prolongation.
* Significant liver, kidney or heart dysfunction.
* Not expected to survive for at least 5 days.
Risk Evaluation of cAncers in Chinese diabeTic Individuals: a lONgitudinal Study

Phase 1: Baseline investigation (nation-wide survey)

Aims: To investigate whether diabetes and prediabetes is a risk factor for cancers of all sites as well as for specific type of cancer, such as breast and colorectal cancer.

Subjects and Methods: A nation-wide survey will be carried out in 200,000-250,000 individuals selected from 20-25 communities stratified according to geographic regions (northeast, north, east, south central, northwest, and southwest China), degrees of urbanization (large cities \[Beijing, Shanghai, and provincial capitals\], midsize cities, county seats, and rural townships), and economic development status (as assessed on the basis of the gross domestic product \[GDP\] for each province). A comprehensive examination including questionnaire, anthropometric measurements, biochemical analysis will be performed in each study participant. Diabetes and prediabetes should be diagnosed by OGTT according to the WHO 1999 criteria, while the diagnosis of cancer is established on the self-report questionnaire and cross checking with the tumor registry or a proof of doctor's diagnosis.

Phase 2: Cohort follow-up

Aims : To examine factors that modify the risk of cancer in diabetes, prediabetes and normal glucose regulation (NGR).

Subjects and Methods: To recruit and follow all type 2 diabetes, prediabetes, and sex,age-matched NGR (1:1) in each community for at least 3 years. For diabetes, treatment target is HbA1c ≤ 7.0% with treatment paradigm recommended by local guideline.


Eligibility Criteria:
Phase 1

Inclusion Criteria:

1. Age \>= 40 years old
2. Gender: males and females
3. Provide written informed consent
4. Satisfactory compliance

Phase 2

Inclusion Criteria:

1. Age \>= 40 and =\< 75 years old
2. Gender: males and females
3. Provide written informed consent
4. Satisfactory compliance

Exclusion Criteria:

1. History of cancer;
2. History of LADA and other autoimmunity diseases;
3. Acute diabetic complication, acidosis, etc;
4. Moderate to severe liver, kidney dysfunction, i.e. ALT/AST \> 2.5 times the upper limit of normal range or Ccr \< 25ml/min;
5. Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.
Transarterial Chemoembolization With Lipiodol in the Treatment of Initial Unresectable Gastric Cancer (GC)

This is a prospective, open-labelled study to evaluate the efficacy and safety of sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of Initial unresectable gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological and imaging diagnosis of gastric adenocarcinoma with initial unresectable R0;
2. Age (18-80 years old) and gender are not limited;
3. No extragastric organ transfer;
4. No serious diseases of the heart, liver, lung, kidney and other organs;
5. Expected survival time \> 3 months;
6. Physical performance status score ECOG ≤1 point;
7. Females of reproductive age must have a negative pregnancy test; or male and female patients must agree to use effective contraception during treatment and within 1 year thereafter.

Exclusion Criteria:

1. Poor coagulation function, INR\>1.5, or ongoing anticoagulation therapy or known bleeding diseases;
2. WBC \<3000/mm3 or platelet count \<50000/mm3;
3. AST and/or ALT \> 3 times the upper limit of normal;
4. Comorbidities or social environment that can cause subjects to fail to follow the research plan or even endanger patient safety;
5. The patient has other primary tumors.
Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years

The purpose of this study is to determine the dosing strategy for adolescents aged 6 to 12 years.

This is an open-label, multi-center, cross-over study in male and female pediatric cancer patients, aged 6 to 12 years of age who are receiving at least 2 cycles of emetogenic chemotherapy requiring 5-HT3 antagonist treatment of up to 5 days duration. The study is designed to evaluate the safety and PK of transdermal granisetron (Sancuso® patch) in a pediatric population (aged 6 to 12 years), using a population PK approach.

Eligibility Criteria:
Inclusion Criteria:

1. 6 to 12 years of age inclusive at screening.
2. Written patient or parental (or appropriate legal representative) IRB approved informed consent as appropriate.
3. Written patient assent (as appropriate).
4. Confirmed malignancy.
5. Scheduled to receive 2 or more cycles\* of emetogenic chemotherapy requiring 5-HT3 antagonist treatment.
6. Scheduled to receive one or more consecutive days of 5-HT3 antagonist treatment, per cycle, as CINV prophylaxis.

   * The cycles of chemotherapy must be consecutive (i.e. one followed by the other) but do not have to be the first and second cycle of a line of treatment.

Exclusion Criteria:

1. Hypersensitivities, allergies or contraindications to study medications; intolerance of medical tape or sticking plaster.
2. Clinical or laboratory signs and symptoms of significant cerebral, cardiovascular, respiratory, renal, hepatobiliary, pancreatic or infectious disease, which in the Investigator's judgment may interfere with the study assessment or completion of the study.
3. Patients with a known history or predisposition to cardiac conduction interval abnormalities, including QT Syndrome, or known family history of long QT Syndrome or taking medications that are known to prolong the QT interval.
4. Patients scheduled to have routine surgery during the study duration.
5. Patients with a life expectancy of \< 6 months.
6. Scarring or significant skin disease on both upper arms.
7. Female patients who are pregnant or breast-feeding. All post menarche female patients must have a pregnancy test at screening.
8. Patients who are known or thought to be sexually active must use effective birth control.\*\*
9. Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments.
10. Any conditions associated with non-compliance.

    * Effective birth control includes absolute abstinence or double barrier birth control methods i.e. condom and one of the following: combined oral contraceptive, diaphragm, depot contraceptive injection.