cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS

To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS), based on the time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in Revised ALS Functional Rating Score (ALSFRS-R) or death, whichever happens first, over the course of the study or until oral edaravone is commercially available in that country


Eligibility Criteria:
Inclusion Criteria:

1. Subjects or their legally authorized representative must provide a signed and dated informed consent form to participate in the study.
2. Subjects must be able (in the judgment of the Investigator) to understand the nature of the study and all risks involved with participation in the study.
3. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
4. Subjects must have successfully completed all Study MT-1186-A02 visits and have been compliant with study drug.

Exclusion Criteria:

1. Subjects of childbearing potential unwilling to use an acceptable method of contraception from the Day 1/screening visit until 3 months after the last dose of study medication. Subjects who are sexually active who do not agree to use contraception during the study period.
2. Subjects who are female, of childbearing potential, and pregnant (a positive pregnancy test) or lactating at the Day 1/screening visit.
3. Subjects who have a significant risk of suicide. Subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Week 48 of Study MT-1186-A02.
4. Subjects who are not eligible to continue in the study, as judged by the Investigator in conjunction with the MTDA medical monitor.
5. Subjects who are unable to take their medications orally or through a PEG/RIG tube.
Lapatinib Plus Trametinib in KRAS Mutant NSCLC

This is an open-label phase I/II multi-center study consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of lapatinib combined with trametinib in patients with metastatic KRASm and PIK3CA wild-type (PIK3CAwt) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the lapatinib-trametinib combination versus standard of care therapy in patients with metastatic KRASm/PIK3CAwt NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological proof of metastatic NSCLC; for PART B: treated with first line therapy for metastatic disease only.
* Written documentation of a known pathogenic KRAS (exon 2, 3 or 4) mutation and PIK3CA wild-type (exon 9 and 20)
* Age ≥ 18 years
* Able and willing to give written informed consent
* WHO performance status of 0 or 1 (part A and B)

Exclusion Criteria:

* Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment.
* History of another primary malignancy
* Symptomatic or untreated leptomeningeal disease
* Symptomatic brain metastasis
* History of interstitial lung disease or pneumonitis
* Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients
* Retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), or a history of uveitis, retinal vein occlusion, central serous retinopathy, or retinal detachment
* Patients with left ventricular ejection fraction (LVEF) \< 50%
Chlorhexidine Dressings for Hemodialysis Catheter Exit Site Care: Comparative Study

The objective of this study is to compare the rate of hemodialysis catheter-related infections according to the treatment regimen: chlorhexidine gluconate dressing or chlorhexidine solution.

Introduction: The use of CVC as a vascular access for haemodialysis is associated with increased morbidity and mortality (up to 10 times higher in a patient with a CVC compared to an arteriovenous fistula), contributing to poorer patient outcomes and increased haemodialysis-related costs.

Aim: To compare the rate of catheter-related infections (bacteraemia, exit site infection and tunelitis) between haemodialysis catheter exit site dressing with 2% chlorhexidine gluconate self-adhesive semi-permeable polyurethane dressings (AGCD); and dressing with 2% chlorhexidine solution and covered with self-adhesive semi-permeable polyurethane dressing (PD).

Methods: A randomized clinical trial will be conducted to compare the occurrence of local and systemic infections related to hemodialysis catheter. Two care groups will be formed in which AGCD and PD dressings will be used. In addition, other clinical variables, patient satisfaction and dressing-related skin alterations will also be analyzed.

Scientific relevance: Infectious complications related with hemodialysis catheter have an increased morbidity, mortality and incremented costs.

Key words: hemodialysis, Central Venous Catheters, Bacteremia, exit site infection, tunnel infection, chlorhexidine gluconate dressing.

Eligibility Criteria:
Inclusion Criteria:

* Be included in the haemodialysis programme in our unit.
* Being a carrier of a tunneled central venous catheter as vascular access.
* Remain on haemodialysis treatment for at least 3 months in our unit.
* Consent to participate in the study.

Exclusion Criteria:

* Allergy or hypersensitivity to chlorhexidine or intolerance to polyurethane dressing
* Active catheter-related infection.
Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fed Conditions

Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets, administered as a 1 x 500 mg tablet under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* healthy men or women, non-smoker, 18 years of age or older
* willing to participate and sign a copy of the informed consent form

Exclusion Criteria:

* clinically significant illnesses or surgery within 4 weeks prior to study dosing
* body mass index greater than or equal to 30.0
* recent history of drug or alcohol addiction or abuse
* pregnant or lactating women
* history of allergic response to naproxen, NSAIDs, or other related drugs, or to heparin
* history of allergic reactions such as asthma, rhinitis, nasal polyps, urticaria, and hypotension associated with the use of aspirin or other NSAIDs
* history or known presence of gastrointestinal ulceration, bleeding and perforation
* use of tobacco products within 6 months prior to study dosing
* evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
* receipt of any drugs as part of a research study within 30 days prior to study dosing
Safety Study of SPARC1104

Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis

Safety study of SPARC1104

Eligibility Criteria:
* Willingness to participate and give written informed consent
* Men and women ≥ 18 years of age
* Sexually active women who are of child bearing potential will practice an acceptable method of birth control for the duration of the trial as judged by the investigator. Examples of acceptable contraception are: condoms, foams, jellies, diaphragm, intrauterine device, oral or long-acting injected contraceptives, bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or having a partner who is incapable of initiating conception. The practice of contraception must have started at least 3 months prior to trial entry.
* If female, negative pregnancy test result at Screening
* Diagnosed with MS and a known history of spasticity
* Meet one of the following criteria o Subjects who completed the double-blind randomized withdrawal phase (Part 3) of trial CLR_09_21 with no major protocol violation
A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With COPD

The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in reducing the daytime cough frequency in patients with chronic obstructive pulmonary disease (COPD).

The effectiveness of XEN-D0501 placebo in reducing capsaicin cough responses, objective 24-hour cough frequency, hourly change in cough frequency, cough severity (via visual analogue scale \[VAS\]), urge to cough (via VAS), global rating of change scale, Clinical COPD Questionnaire (CCQ), Leicester Cough Questionnaire (LCQ), and St George's Respiratory Questionnaire (SGRQ-C) will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Male/female subjects aged 40 or over with COPD

Exclusion Criteria:

* Clinically significant medical history
* Abnormal laboratory results, ECGs or vital signs
Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive Dyskinesia

The aim of the study was to evaluate the efficacy, safety, and cognitive function of transcranial direct current stimulation (tDCS) in chronic schizophrenia patients with tardive dyskinesia (TD).

This study is a randomized, double-blind, sham-controlled clinical trial. 60 patients with TD were randomly allocated to active (n=30) or sham tDCS groups (n=30). All patients received 2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions: Monday to Friday once daily, every other week to do a group of treatment). Abnormal Involuntary Movements Scale (AIMS), Tardive Dyskinesia Rating Scale (TDRS), Assessment of Negative Symptoms(SANS), the Positive and Negative symptom scale(PANSS), and the Cambridge Neuropsychological Test Automatic Battery (CANTAB) were assessed in patients. All evaluations were scored at baseline, the end of 3rd weeks, 5th weeks, and 7th weeks. Side effects of tDCS were assessed with an experimenter-administered open-ended questionnaire during the whole experiment.

Eligibility Criteria:
Inclusion Criteria:

1. Right-handed;
2. meeting the diagnosis of schizophrania;
3. had been receiving antipsychotic drugs for at least 12 months;
4. at least one AIMS item rated(moderate) or at least two AIMS items rated ≥2(mild);
5. All patients volunteered to participate in this study.

Exclusion Criteria:

1. organic disorder that could cause movement disorders, mental retardation,and a history of substance dependence(except nicotine);
2. with serious physical illness(e.g.severe cardiovascular diseases);
3. with color blindness/weakness, stuttering, deafness.
Some Biomarkers in Bronchial Asthma in Children

Asthma, a disease characterized by chronic airway inflammation and hyper -responsiveness, is a common disease that affects all age groups. Asthma may be manifested as irreversible airflow obstruction in some patients. Although the pathogenesis of asthma is not well understood, increased oxidative stress due to an imbalance of oxidants and antioxidants has been found to be associated with asthma. In asthma, inflammation-related oxidative stress is driven by exposure to a variety of triggers, including allergens and viruses, which activate components of both the innate and acquired immune responses. Protection by escaping from triggering factors or standardization of asthma medication is difficult and usually is not enough for effective treatment. On the other hand, correction of antioxidative systems may be more efficacious in the control of asthmatic inflammation and asthma symptoms.

Little is known about the role of asymmetric dimethylarginine in the pathogenesis of asthmatic airway inflammation. The lung is a major source of asymmetric dimethylarginine that can promote oxidative stress by a reduction in nitric oxide synthesis which would result in higher levels of peroxynitrite, that causes oxidative cell damage, and exacerbate airway inflammation. asymmetric dimethylarginine can modify lung function, increase airway hyper-reactivity even in non-inflamed airways, and promote lung collagen production and deposition. Increased asymmetric dimethylarginine in serum has been found to be associated with the severity of symptoms of asthma in obese adults.

Malondialdehyde is an oxidant marker of pulmonary oxidative stress, and lipid peroxidation. Paraoxonase, an antioxidant enzyme may play a protective role in asthma. It hydrolyzes lipid peroxides and prevents low-density lipoprotein oxidation.


Eligibility Criteria:
• All known asthmatic patients aged six years or more who will be regularly attending Assuit University Children's Hospital Outpatient clinic.

Exclusion criteria include

* Obese children,
* The presence of chronic heart, liver and kidney diseases, concomitant chronic inflammatory disease and autoimmune disorders, and Diabetes mellitus.
* Patients taking antioxidant drugs, vitamins, diuretics, hormone replacement therapy will be also excluded.
* Children aged less than six years. 5-children who have symptoms of lower or upper respiratory tract infection or asthma exacerbation within the previous four weeks.
Immune Response to Influenza Vaccination

The purpose of this study is to evaluate the immune response to a routine influenza vaccination. Influenza vaccination is given as part of routine standard of care in these individuals and is not part of the study protocol. The study will evaluate for a change in response to common antigens over time after influenza vaccination to determine if changes are related to the development of chronic rejection after solid-organ transplantation. We hypothesize that the influenza vaccine contributes to the alloreactivity of T cells verses common HLA types in the donor pool.


Eligibility Criteria:
Inclusion Criteria:

* Transplant recipients (lung or kidney) 18 years or older, more than 3 months after transplantation
* Transplant candidates (kidney) 18 years or older, to recieve influenza vaccination
* Healthy volunteers to receive influenza vaccination

Exclusion Criteria:

* Under 18 years of age
* Pregnant
* Medical contraindication for vaccine
* Transplant recipients receiving acute rejection therapy within one month
* Healthy volunteers with autoimmune disease or medications to mediate immune function
* Receipt of live, attenuated influenza vaccine, instead of injectable vaccine
Efficacy and Safety of ESD for the Treatment of Superficial Gastric Neoplasms

Endoscopic submucosal dissection (ESD) is the technique that has replaced surgery in the treatment of early neoplastic lesions of the stomach (LNPS). ESD of LNPS allows: a) less invasiveness compared to surgery; b) greater chances of "en bloc" resection and R0 resection compared to mucosectomy for lesions larger than 15 mm. Recent 2015 ESGE guidelines provide precise recommendations for the use of ESD in the treatment of LNPS, but Italy lacks prospective data on the efficacy and safety of ESD in a large sample of patients. A multicenter prospective observational study to create a database on the use of ESD in LNPS is essential to provide information regarding the efficacy and safety of ESD in Italy. This database would also provide information regarding the criteria applied in the use of ESD in the treatment of early gastric neoplasia


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Endoscopic and histologic diagnosis of gastric superficial neoplasm that can be treated by ESD according to ESGE guidelines.
* Gastric neoplasm outside of latest ESD guidelines criteria in patients unfit for surgery

Exclusion Criteria:

* Final diagnosis of non neoplastic lesion.
* Gastric neoplasm outside of latest ESD guidelines criteria in patients fit for surgery
* Evidence of muscolar layer invasion or limph nodes or other organs metastasis at EUS or TC when performed.
Short-term Results After Minimally Invasive Chevron Osteotomy for Hallux Valgus Correction

By means of clinical satisfaction and clinical scores comparison of an open to a minimally invasive distal chevron osteotomy for correction of a hallux valgus deformity is performed.

The aim of this study is to evaluate shortterm clinical outcome after a minimally invasive chevron osteotomy technique for correction of hallux valgus deformity in comparison to the open distal chevron technique. Patients undergoing a distal chevron osteotomy for correction of a hallux valgus deformity are assigned to one of the two groups. Survey is taken preoperatively, after 2, 4, 6 and 12 weeks postoperatively. Assessment of the clinical outcome measures in terms of the range of motion (ROM), Visual Analogue Scores (VAS) of pain, the American Orthopaedic Foot and Ankle Society (AOFAS) forefoot Score and a patient satisfaction score and a Life Quality score (SF 12) as well as the evaluation of the Charlson Comorbidity score is performed. It is hypothesized, that clinical outcome with the minimally invasive distal chevron osteotomy is superior to the open technique.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing hallux valgus correction by means of a distal chevron osteotomy

Exclusion Criteria:

* surgery on the lesser rays of the same foot
* mental illness with impossibility to follow the postoperative protocol
The Effects of Hemodialysis Session on Vascular Stiffness

Central blood pressure and pulse wave velocity were measured using a Complior Analyse device before and immediately after the end of the dialysis session.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* patients on maintenance hemodialysis at least 3 months
* stable dry weight
* single-pool Kt/V \>1.4
* no clinical cardiovascular disease during the 6 months preceding entry
* medical staff (medical doctors, nurses)

Exclusion Criteria:

* not meet the above criteria
* episode of illness (for example: infection)
* pregnancy
Cohort Study of Chronic Heart Failure

The purpose is to understand the clinical characteristics of chronic heart failure as soon as possible, analyze the etiology, comorbidities, clinical characteristics, and treatment of heart failure patients, observe the gap between real-world clinical practice and guideline recommendations, and provide reference for the improvement of heart failure prevention and treatment in China.

Inclusion criteria:

1. Accompanied by difficulty breathing, fatigue, or decreased activity tolerance;
2. Signs of fluid retention (pulmonary congestion and peripheral edema);
3. Echocardiography shows abnormalities in cardiac structure and/or function;
4. Elevated levels of natriuretic peptide: B-type natriuretic peptide (BNP)\>35 ng/L and/or N-terminal B-type proBNP (NT proBNP)\>125 ng/L.
5. HF hospitalization recorded within the previous 12 months

Exclusion criteria:

1. Concomitant severe liver function, renal failure, or other severe system dysfunction
2. Poor compliance, inability to obtain information, or voluntary refusal to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Accompanied by difficulty breathing, fatigue, or decreased activity tolerance;
2. Signs of fluid retention (pulmonary congestion and peripheral edema);
3. Echocardiography shows abnormalities in cardiac structure and/or function;
4. Elevated levels of natriuretic peptide: B-type natriuretic peptide (BNP)\>35 ng/L and/or N-terminal B-type proBNP (NT proBNP)\>125 ng/L.

Exclusion Criteria:

1. Concomitant severe liver function, renal failure, or other severe system dysfunction
2. Poor compliance, inability to obtain information, or voluntary refusal to participate in this study.
A Pilot Study to Explore the Role of Gut Flora in Rheumatoid Arthritis

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Rheumatoid Arthritis

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Rheumatoid Arthritis.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with mothers).
3. Diagnosis of Rheumatoid Arthritis

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Trivalent Influenza Vaccine in Preventing Flu in Patients With Central Nervous System Tumors

This pilot clinical trial studies trivalent influenza vaccine in preventing flu in patients with central nervous system (CNS) tumors. Flu vaccine may help the body build an effective immune response and help prevent flu in patients who are receiving chemotherapy for CNS tumors

PRIMARY OBJECTIVES:

I. The primary objective of this pilot study is to assess the efficacy of influenza vaccination in patients with central nervous system tumors as defined by a four-fold increase in hemagglutinin inhibition (HI) titers from the pre-vaccination baseline.

SECONDARY OBJECTIVES:

I. A secondary objective of this pilot study is to assess the efficacy of influenza vaccination in patients with central nervous system tumors as defined by a serum post-vaccination HI titer of at least 1:40.

II. The secondary objectives of this pilot study include an assessment of the relationship between a variety of clinical factors and seroconversion following influenza vaccination.

III. Subgroup analyses will include an investigation of seroconversion and treatment (actively receiving chemotherapy, radiation therapy or both), disease status (active treatment vs long term followup), and use and dose of glucocorticoids.

TERTIARY OBJECTIVES:

I. An additional area of interest which will be further explored in this pilot study is an assessment of the relationship between serologic markers of immune function and response to vaccination.

OUTLINE:

Patients receive trivalent influenza vaccine intramuscularly (IM) on day 0.

After completion of study treatment, patients are followed up at 14 days, 21 days, and 3 and/or 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a clinical diagnosis of a primary central nervous system tumor
* Patients must be eligible to receive the influenza vaccine
* Patients must be able to provide written informed consent

Exclusion Criteria:

* Patients unable to receive the influenza vaccine due to history of allergy to egg proteins, allergy to influenza vaccine component, acute febrile illness at the time of proposed vaccine administration, history of clinically or virologically confirmed influenza infection in the previous 6 months, contraindication to intramuscular injections, Guillan-Barré syndrome, or other contraindication to the vaccine
* Patients who have received the 2011-2012 annual influenza vaccine prior to being considered for enrollment on this study