cyrilzakka/clinical-trials huggingface dataset:
Immune Checkpoint Inhibitors in Advanced Non-small Cell Lung Cancer and Discovery of New Biomarkers

Lung cancer patients have a poor prognosis and only around 20 % is alive after 5 years. However, for advanced non-small cell lung cancer immunotherapy has become a cornerstone of treatment.

Two immunotherapeutic drugs for lung cancer have been approved in the last two years. Immunotherapy blocks the capability of cancer cells to inactivate the patient´s immune system, thus re-enabling eradication of cancer cells. In clinical trials, immunotherapy has shown superior survival and less toxicity compared to standard chemotherapy.

Whether the patients are candidates for immunotherapy or not is currently based on an unprecise biomarker that poorly predicts the patients who may benefit from immunotherapy. Immunotherapy can cause severe adverse effects and is expensive. Consequently, novel biomarkers are urgently needed from a patient perspective as well as a socioeconomic perspective.

The objective of the project is to investigate changes in genes and other signals in tissue and blood samples from immunotherapy treated lung cancer patients. The investigators expect to identify new biomarkers that can predict with high precision, which patients may benefit from immunotherapy. On-treatment, the investigators also aim to identify biomarkers that predict the treatment response and reveal the underlying mechanisms when cancer cells become resistant to the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy verified NSCLC
* ≥ 18 years
* WHO/ECOG performance status ≤ 2
* Measurable disease according to RECIST 1.1
* Candidate for immunotherapy treatment
* Understand and accept oral and written information
* Written informed consent

Exclusion Criteria:

* Candidate for surgical and/or oncological treatment with curative intention
* Other synchronous cancer
Effect of Neuromuscular Electrical Stimulation on Phrenic Nerve Regeneration Post Cardiac Surgeries

This study will be conducted to investigate the effect of neuromuscular electrical stimulation on phrenic regeneration post cardiac surgery

Phrenic nerve injury post cardiac surgery is a serious problem closely related to frequent respiratory complications. It has been associated with diaphragm dysfunction, pneumonia and difficulty weaning from mechanical ventilation in critical ill patients.

Neuromuscular electrical stimulation (NMES) is commonly used in physical therapy to increase muscle strength and promote muscle hypertrophy.

There is increased flow of patients after heart surgery in kasr Aini hospital who suffers from respiratory complication due to phrenic nerve injury so the hospitalization period of them increased which make economic burden in health insurance services with decreased level of quality of life that is the most concern as to improve patient status and relief this burden. So this study aims to decrease respiratory complication and improve phrenic nerve regeneration by using neuromuscular electrical stimulation as a safe, noninvasive , inexpensive and virtually risk free method.

Eligibility Criteria:
Inclusion Criteria:

* Patients post cardiac surgery (coronary artery bypass graft, valve repair or replacement ).
* Patients referred by physician.
* Medically stable patients.
* Both genders
* Ages from 25 to 45
* BMI 25-29.9 kg/m2
* Able to understand the requirements of the study.
* Conscious patient and respond to verbal commands.

Exclusion Criteria:

Participants will be excluded if they meet one of the following criteria:

* Patients with rib fracture.
* Patients developing lung cancer.
* Patients have dementia.
* Patients on mechanical ventilator after 24 hours
* Metabolically unstable chronic illness
Neurofeedback for Stroke Rehabilitation

Real-time neurofeedback aims to alter brain activation patterns through online feedback of ongoing brain activity using magnetic resonance imagining (MRI). Stroke survivors will be randomised to receive 3 sessions of real or sham neurofeedback. This study aims to investigate whether: 1) stroke survivors can maintain alterations in brain activity after the feedback is removed, 2) neurofeedback training leads to improvements in movement of the hand and arm, 3) neurofeedback training leads to changes in brain structure and function, 4) variability in response across people can be understood.

Many stroke survivors experience impairment in upper limb function, reducing independence in activities of daily living. These impairments are associated with atypical brain activity patterns. Real-time neurofeedback aims to alter brain activation patterns through online feedback of ongoing brain activity using magnetic resonance imagining (MRI). Patterns of brain activity are displayed to a participant while a task is being performed. The participant is instructed to try to alter the patterns in a particular way, promoting specific brain activity patterns. Previous studies have found that people with and without stroke are capable of utilising the feedback to alter their brain activity. This study aims to investigate whether:

1. stroke survivors can maintain alterations in brain activity after the feedback is removed
2. neurofeedback training leads to improvements in movement of the hand and arm
3. neurofeedback training leads to changes in brain structure and function
4. variability in response across people can be understood.

30 stroke survivors (\> 6 months after stroke), with residual upper limb impairment, will be recruited between February 2018 and December 2020. Participants will be randomised to receive 3 sessions of real or sham neurofeedback over one week, taking place at the Wellcome Centre for Integrative Neuroimaging, University of Oxford. Changes in brain activity during affected hand movements will be assessed with and without feedback using functional MRI and after feedback sessions using electroencephalography (EEG). Brain connectivity and structure will also be assessed using MRI at baseline and at a follow-up one week later. Clinical measures of upper limb function and impairment will be performed at baseline and at follow up sessions one week and one month later (Action Research Arm Test, Fugl-Meyer upper limb assessment, Jebsen Taylor hand function test), and in each session following neurofeedback (Jebsen taylor test).

Eligibility Criteria:
Inclusion Criteria:

* Stroke \> 6 months previously
* Unilateral upper limb impairment, but physically able to complete the tasks required

Exclusion Criteria:

* Contraindications to MRI, such as a pacemaker, metallic implants or aneurysm clips
* Inability to provide informed consent
* Inability to actively participate in the research procedures
Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children

The web-based continuity of care intervention model to provide comprehensive nursing interventions for obese children with NAFLD, always tracking their performance status, enabling them to grasp the knowledge of healthy weight loss, develop good lifestyle habits, and reduce their weight, thus reducing the incidence of NAFLD in children.

The web-based continuity of care intervention model to provide comprehensive nursing interventions for obese children with NAFLD, always tracking their performance status, enabling them to grasp the knowledge of healthy weight loss, develop good lifestyle habits, and reduce their weight, thus reducing the incidence of NAFLD in children.The primary outcome are serum biomarkers such as alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) . Second outcomes are: aspartate aminotransferase, and liver imaging (liver ultrasound and magnetic resonance imaging), BMI, waist-to-hip ratio and quality of life. In addition, socio-demographic characteristics such as age, gender and ethnicity will be recorded. All outcomes were measured at baseline, week 4, week 16, week 24, week 36, and week 48 to determine the trajectory of change in outcome variables over intervention process.

Eligibility Criteria:
Inclusion Criteria:

* The clinical diagnosis of Nonalcoholic Fatty Liver Disease

Exclusion Criteria:

* Patients do not agree to participate
* participate in other health intervention programs now
Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy

The intent of this protocol is to provide continued access to vamorolone for subjects in the United States who Have Completed the VBP15-LTE, VBP15- 004, or VBP15-006 protocols (and are thereby ineligible to enroll in another trial of vamorolone therapy), during the time a new drug application for vamorolone is under preparation and review.

Vamorolone will be shipped to the subject's family by the study site. The patient will receive standard of care treatment and procedures for management of DMD. Treating Physicians participating in the expanded access program are required to collect and document any physician, patient, or caregiver reported safety events and report to the Sponsor. The subject's dose of vamorolone may be increased or decreased within a range of 2.0 to 6.0 mg/kg/day (only doses of 2 mg/kg, 4 mg/kg and 6 mg/kg are allowed), given once daily. Administration of vamorolone (taken with an 8 ounce (240 ml) glass of full fat milk, or equivalent high-fat food portion) will be unchanged from the VBP15-LTE, VBP15-004, or VBP15-006 studies. In the absence of safety concerns, and while this Expanded Access protocol isactive, vamorolone may be provided indefinitely or until approval, providedthat the Treating Physician and family agrees that continued administrationof vamorolone is in the best interest of the child.

Eligibility Criteria:
Inclusion Criteria:

* Subject's parent or legal guardian has provided written informed consent/HIPAA authorization
* Subject has previously completed at a participating US or Canada study site VBP15-LTE up to and including the Month 24 assessments, OR VBP15-004 up to and including the Week 48 assessments, VBP15-006 up to and including the Week 12 assessment
* Subject and parent/guardian are willing and able to comply with recommended study drug administration plan, and standard of care follow-up and monitoring as recommended by their Treating Physician

Exclusion Criteria:

* Subject had a serious or severe adverse event in study VBP15-LTE or VBP15-004 or VBP15-006 that, in the opinion of the Treating Physician and Sponsor, was probably or definitely related to vamorolone use and precludes safe use of vamorolone for the subject in this expanded access program
* Subject and/or parent/guardian are unable and/or unwilling to comply with regular medical care and follow-up as recommended by their Treating Physician throughout participation in the VBP15-EAP
Pilot Study for a National Screening for Familial Hypercholesterolemia

A pilot study to study the feasibility of the screening of familial hypercholesterolemia within the setting of the legal medical visits at primary school.

The pilot study shall evaluate whether this screening set-up is efficient to detect patients having familial hypercholesterolemia, detect further patients by an adjacent cascade screening of family members, to deliver treatment to these patients and to provide this screening in a cost-effective manner.

Pilot study evaluating the feasibility of a screening for familial hypercholesterolemia.

Cross-sectional design. Primary outcome Percentage of screened school children with confirmed familial hypercholesterolemia Participants All children, who attend a public primary school in the city of Luxembourg and are enrolled in the cycle C2.2 (age of 7-8 years; 3rd medical visit at school), cycle C3.2 (age 9-10 years, 4th medical visit at school) and cycle 4.2 (age 11-12 years, 5th medical visit at school) will be invited to participate. Expected number of invited children is around 1600 children/year.

Recruitment will take place during the school year 2021/2022 and 2022/2023. The parents/caregivers of these children will receive written information about the screening. They will receive as well a questionnaire on the family history of premature cardiovascular events and known FHC disease.

Without informed consent, the child cannot be included in the screening program.

All children with signed informed consent will have a finger prick for a capillary blood test in the setting of their medical school exam by an external study nurse (not the school nurse) All data (pseudonymised) on each participant will be entered in the online data base for further analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Attending primary school in the city of Luxembourg and invited for the legal medical visit

Exclusion Criteria:

1. No parental informed consent
Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS

Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)

Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients with Chronic Fatigue Syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patients meeting the CDC definition of CFS.
* All races, ethnicities, socio-economic status (SES), and gender
* Age greater than 18 (because of concerns about radioactivity, we and the Cedars-Sinai and Harbor-UCLA IRBs have decided not to enroll subjects below the age of 18).
* Age less than 50. Because of concern of sildenafil exacerbating coronary artery disease, we will only enroll patients younger than 50.
* Able to provide informed consent.
* Willingness to be off all medicines and supplements for 3 weeks prior to the study.
* Patients with psychiatric disorders (see below) will be included, if they could be off their medications, and if their psychiatric diagnosis clearly occurred after their fatigue symptoms began.
* Patients with concurrent fibromyalgia will be allowed to participate if the meet diagnostic criteria for CFS.

Exclusion Criteria:

* Disabilities that would prevent them from participating in the study.
* Current use of prescription medicines (starting at 3 weeks prior to the study) and supplements (starting at 1 weeks prior to the study) except acetaminophen or aspirin. This includes herbal supplements and vitamins.
* Existing medical illnesses, such as heart disease, hypertension, cancer, rheumatological diseases, endocrinopathies or hormone replacement therapy, seizure disorders, severe obesity (BMI \> 32 kg/m2),
* Severe psychiatric disorders including bipolar disorder, schizophrenia, dementia and previous or current diagnosis of alcohol or substance abuse within the past year. Patients with depression of such severity as to warrant treatment with anti-depressants will be excluded.
* Current abuse of illicit drugs or heavy ethanol use.
* Pregnant women will be excluded because of radioactivity exposure from the SPECT scans.
* Abnormal EKG
* Abnormal CBC, blood chemistries, thyroid function tests, and HIV, ANA, RF and ESR tests.
Sperm DNA Damage in β-thalassemia Major: Is There a Role for Antioxidants?

Accumulation of iron in patients with beta thalassemia major causes free radical formation which leads to damage of biological membranes. Sperm DNA damage may result from these generated antioxidants.

We aimed at investigating the current DNA damage in the sperms of adult patients with beta thalassemia major and the effect generated by giving antioxidant treatment for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Pubertal patients with beta thalassemia major

Exclusion Criteria:

* Associated endcrinopathy
Intraoperative Anuric Episodes in Patients Undergoing Laparotomy

A single-center prospective observational study. This study examines urine flow and haemodynamic parameters during abdominal surgery and analyses the association to postoperative renal function and markers and to postoperative clinical outcome.

Primary hypothesis:

• Within a goal-directed haemodynamic protocol during gynecologic cancer surgery there are phases of temporary anuria.

Secondary hypothesis:

* Perioperative anuric phases are directly associated to the postoperative increase of NGAL (neutrophil gelatinase-associated lipocalin) and creatinine
* Perioperative renal dysfunction is directly associated to postoperative complications and functional recovery of patients
* A response of urine flow to a standardized postoperative diuretic bolus can identify patients who benefit from a pharmaceutical fluid mobilization
* Within a goal-directed haemodynamic protocol during gynaecologic cancer surgery, the methods for the measurement of stroke volume of the heart differ


Eligibility Criteria:
Inclusion Criteria:

* Offered patient information and written informed consent
* Female patients aged greater than or equal to 18 years for cytoreductive surgery of a primary epithelial ovarian tumour

Exclusion Criteria:

* Patients with relapse Ovarian Cancer
* Patients aged less than 18 years
* Persons without the capacity to consent
* Unability of German language use
* Lacking willingness to save and hand out data within the study
* Accommodation in an institution due to an official or judicial order
* (Unclear) history of alcohol or substances disabuse
* Coworker of the Charité
* Advanced disease of the oesophagus or upper respiratory tract at the beginning of hospitalisation
* Operation in the area of the oesophagus or nasopharynx within the last two months before participation in the study
* Neurological or psychiatric disease at the beginning of hospitalisation
* CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospitalisation
* American Society of Anaesthesiologists (ASA) classification greater than IV
* Renal insufficiency (dependency of haemodialysis) at the beginning of hospitalisation
* Pulmonal oedema in thorax x-ray at the beginning of hospitalisation
* History of intracranial hemorrhage within one year before participation in the study
* Conditions following venous thrombosis within the last three years before study inclusion
* Known allergies or hypersensitivity on colloidal, starch or gelatine infusion solutions
* Diabetes mellitus with signs of severe neuropathy
Interest of Tumor Replicates in Avian Embryo to Model Therapeutic Effects of BRAFi/MEKi in BRAF Mutated Melanoma

This is an interventional mono-centric study in patients with BRAF mutated metastatic melanoma treated with BRAF/MEK inhibitors. The aim of the study is to test the grafting of patient tumoral cells in avian embryo and develop a predictive in vivo model for patient treatment response.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years
* Signed written informed consent
* Patient with BRAF V600 mutated metastatic or unresectable melanoma histologically confirmed
* BRAFi/MEKi treatment indication
* Patient with skin tumor (excluded face and skinfold) available for biopsy
* Measurable disease as defined by RECIST v1.1 criteria
* Patient affiliated to or a beneficiary of a social security category

Exclusion Criteria:

* Ocular melanoma
* Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
* Pregnant or nursing (lactating) women
* Patients protected by law
Does Instruction on Cognitive Aid Use Improve Performance and Retention of Skills?

The purpose of this study is to investigate whether formal instruction on the use of cognitive aids in managing a crisis will result in better longterm retention of knowledge and skills. In particular, this study examines the impact of cognitive aid teaching on the Advanced Cardiac Life Support course.


Eligibility Criteria:
Inclusion Criteria:

* Post-graduate Medical trainee in departments of Anesthesia, Emergency Medicine, Critical Care, Family Medicine, Internal Medicine
* Has taken ACLS Course at least once

Exclusion Criteria:

* Never taken ACLS Course
Prospective Study on Intensive Early Rheumatoid Arthritis Treatment

Hypothesis: Early intensive treatment with anti-TNF agent plus methotrexate plus high dose prednisone may increase remission rate and may induce stable remission in Rheumatoid Arthritis Objective: to evaluate induction of remission using adalimumab, prednisone and methotrexate and maintenance of remission after discontinuation of adalimumab and prednisone

Treatment group A 0 - 6 months: Adalimumab 40 mg eow + methotrexate rapidly titrated to 20 mg weekly + prednisone 50 mg/d tapered to 6.25 mg 6 - 12 months: Adalimumab 40 mg eow plus methotrexate 20 mg weekly group B 0 - 6 months: Adalimumab 40 mg eow + methotrexate rapidly titrated to 20 mg weekly + placebo 6 - 12 months: Adalimumab 40 mg eow + methotrexate rapidly titrated to 20 mg weekly

Follow up period - Open Label phase:

Patients achieving clinical remission will be than treated only with MTX and observed for another 12 months period. Patients who do not achieve clinical remission or patients who will experience a relapse of the disease will be treated according to standard of care (SOC) modalities.

Eligibility Criteria:
Inclusion Criteria:

* Active rheumatoid arthritis diagnosed for at least 6 weeks, but no more than 1 year, according to the revised 1987 ACR criteria
* Naïve to treatment with MTX
* Swollen joint count (SJC) \> 8 tender joint count (TJC) \> 8
* At screening CRP \> 1.5 mg/dL (15 mg/L) or ESR ≥ 28 mm/h
* ≥ 1 joint erosion or RF positivity or anti-CCP positivity
* Age 18-70 years.

Exclusion Criteria:

* Rheumatic autoimmune disease other than RA
* Functional class IV
* Any surgical procedure within 12 weeks prior to baseline or planned during the study.
* Pregnancy or breast feeding.
* Evidence of significant concomitant disease
* Primary or secondary immunodeficiency
* active infection of any kind
* History of previously untreated infection with mycobacterium tuberculosis or current treatment for same.
* History of cancer
* Any history or presence of congestive heart failure (CHF) (New York Heart Association classification for CHF: Class III or IV).
* Any history of myocardial infarction within 5 years.
* History of a severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of adalimumab or methotrexate.
* Positive serology for hepatitis B or C indicating active infection.
* Hemoglobin \< 8.0 g/dL.
* Absolute neutrophil count (ANC) \< 1.5 x 103/L.
* Liver function abnormality
Evaluation of Values in Perspective (VIP) Program

The purpose of this study is to review and assess the usefulness of the Values in Perspective (VIP) program to avoid adolescent risky behaviors.


Eligibility Criteria:
Inclusion criteria

1. A youth residing in Miami-Dade County.
2. Must be in grades 6-12 and must be eligible for free and reduced lunch.
3. Must be able to speak and read English proficiently.

Exclusion criteria

1. Does not reside in Miami-Dade County.
2. Does not comprehend, speak, or read English proficiently.
3. In elementary school.
4. In high-income household as evidenced by not qualifying for free and reduced lunch.