cyrilzakka/clinical-trials huggingface dataset:
Anakinra to Prevent Post-infarction Remodeling

Thousands of patients die daily from early and late complications of a heart attack (acute myocardial infarction, AMI). Patients surviving AMI remain at high risk of death from adverse cardiac remodeling (dysfunction and enlargement of the heart) leading to heart failure (weakening of the heart).

Current interventions proven to reduce adverse remodeling and progression to heart failure include early reperfusion (restoring blood flow to the heart muscle) and long-term use of medicines that block the effects of hormones (such as angiotensin II, norepinephrine and aldosterone) involved in adverse remodeling. Despite these treatments, however, many patients continue to develop heart failure within 1 year of AMI. These patients are at very high risk of death.

Numerous changes occur in the hearts of patients after AMI that lead to adverse remodeling. Ischemia (lack of oxygen) and infarction (cell damage) lead to increased interleukin-1 (IL-1) production in the heart. IL-1 plays a critical role in adverse cardiac remodeling by coordinating the inflammatory pathway (leading to wound healing) and apoptotic pathway (leading to cell death).

In opposition to IL-1 activity, the human body produces a natural IL-1 receptor antagonist that blocks the effects of IL-1. The drug form of this IL-1 receptor antagonist (anakinra) is currently FDA approved for the treatment of rheumatoid arthritis, an inflammatory disease characterized by excessive IL-1 activity. Experimental studies show that anakinra is able to prevent cardiac remodeling and improve survival in mice after AMI.

We hypothesize that anakinra will show similar benefits in human patients by preventing adverse remodeling and heart failure after AMI.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Acute (\<24 hours) onset of chest pain
* New or presumably new ST elevation on ECG
* Planned coronary angiography for percutaneous revascularization

Exclusion Criteria:

* Inability to give informed consent
* Late presentation (\>24 hours)
* Unsuccessful revascularization or urgent coronary bypass surgery
* Hemodynamic instability
* End-stage congestive heart failure (AHA/ACC stage C/D, NYHA class IV)
* Preexisting severe LV dysfunction (LVEF\<20%) or severe valvular disease
* Severe asthma
* Pregnancy ( pre-enrollment pregnancy test)
* Contraindications to cardiac MRI or cardiac angiography
* Severe coagulopathy (INR\>2.0, Platelet count\<50,000/mm3)
* Severe renal insufficiency (creatinine clearance \<30 ml/min/m2)
* Recent (\<14 days) use of anti-inflammatory drugs (NSAIDS excluded)
* Chronic inflammatory disease
Efficacy of ONS Supplementation in HNC Outpatient Under Treatment

A RCT study to compare the efficacy of ONS supplementation with standard dietary advice on nutritional outcome inHNC outpatients undergoing treatment in radiotherapy clinic. IThe study population are all adult HNC outpatients receiving radiotherapy with or without chemotherapy treatments at Radiotherapy Clinic,NCI. Selected patient will be randomized into Control Group and Intervention Group until each group have 20 subjects, where the total of sample will be 40 patients (in consideration of 50% dropouts) and data will be collected at baseline (prior to treatment), week 2, 4, and the final data will be at week 6 or final day of cancer treatment. Study objectives are to determine the efficacy of ONS supplementation in outpatient HNC undergoing treatment in Radiotherapy Clinic, NCI, to determine nutritional outcome (weight loss and BMI, body composition, dietary intake, albumin and hemoglobin level), functional outcome (handgrip strength) and side effect outcome (nutrition impact symptoms) in HNC outpatients given intensive nutrition intervention with outpatients given routine care. This study also want to find association of Intensive nutrition intervention versus routine care in nutrition outcome, functional and side effect outcome in both group. Subjects in intervention group will received standardize ONS supplementation every day during treatments once daily with frequent dietary advice accordingly to the patients condition while control group will received standard routine care which includes frequent dietary advice without supplementation of ONS. Study hypothesis is there is no significant difference in nutritional outcome, functional outcome and side effect outcome between HNC outpatients receiving INI when compared to HNC outpatient receiving routine care undergoing radiotherapy treatment. There is also no association between these two groups in nutritional outcome, functional outcome and side effect outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Those who diagnosed with Head and Neck Cancer (HNC) and receiving radiotherapy with or without chemotherapy treatments.
2. Able to communicate.
3. Patient admitted to ward less than 5 days.

Exclusion Criteria:

1. Patient on tube feeding.
2. Patient was already on ONS before study period.
3. Patient already started treatments (referring to chemotherapy, radiotherapy and CCRT) before study period.
Perioperative Immunotherpay Versus Adjuvant Immunotherapy for Resectable Non-small Cell Lung Cancer

For resectable non-small cell lung cancer, neoadjuvant immunochemotherapy plus adjuvant immunotherapy or adjuvant immunochemotherapy is usually used in clinical practice. However, it is unclear whether therapeutic strategy is superior. This trial aims to compare the efficacy and safety of these two strategies.


Eligibility Criteria:
Inclusion Criteria:

1. The patient shall sign the Informed Consent Form.
2. Aged 18 ≥ years.
3. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage II-IIIB (N2) confirmed by imageological examinations (CT, PET-CT or EBUS).
4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
5. Life expectancy is at least 12 weeks.
6. At least 1 measurable lesion according to RECIST 1.1.
7. Patients with good function of other main organs (liver, kidney, blood system, etc.)
8. Patients with lung function can tolerate surgery;
9. Without systematic metastasis (including M1a, M1b and M1c);
10. Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of immunotherapy (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
11. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of immunotherapy (whichever is later).

Exclusion Criteria:

1. Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
2. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
4. Participants who are allergic to the test drug or any auxiliary materials;
5. Participants with Interstitial lung disease currently;
6. Participants with active hepatitis B, hepatitis C or HIV;
7. Pregnant or lactating women;
8. Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
9. Participated in another therapeutic clinical study;
10. Other factors that researchers think it is not suitable for enrollment.
Urdu Version of Frenchay Activities Index: Reliability and Validity Study

In this study, we will observe the reliability and validity of frenchay activities index and barthel index in urdu language in geriatric population of Pakistan.

The aim of study is to translate and culturally adapt Frenchay Activities Index and Bathel Index into Urdu language and secondly to investigate the reliability and validity of Frenchay Activities Index and Barthel Index in geriatric population of Pakistan. This study will be cross sectional survey study in which convenience sampling technique will be used.

The results of study will help to know the validity and reliability of Frenchay Activities Index and Barthel Index in Urdu version with Activities of Daily Livings impairments in geriatric population of Pakistan. The reliability of the questionnaire will be checked through internal consistency and test-retest methods. internal consistency will be analyzed with Cronbach's alpha value. Test-retest reliability will be assessed using an intra-class correlation coefficient with 75 patients.

Eligibility Criteria:
Inclusion Criteria:

* 65 years old and older
* be able to read Urdu
* be living in Pakistan for more than 5 years
* have minimal cognitive impairment with Mini-Mental State Examination
* have no significant muscle, joint, or neurologic conditions such as stroke, or Parkinson's disease.

Exclusion Criteria:

* inability to understand to follow the instructions of Frenchay Activities Index and Barthel Index
* experience with the Frenchay Activities Index and Bathel Index in the last 6 months
* acute illness or fracture in the lower extremities
Effects of Intermittent Pneumatic Compression Following an Officiall Soccer Match

This study aims to identify the effects of the use of intermittent pneumatic compression on the recovery kinetics following an official soccer match, in comparision with a placebo condition. Participants will perform neuromuscular tests (ie, cmj, broad jump) and respond to perception scales (RPE, hooper index). These assessments will be carried out before the match, 30 minutes post match, at the 24th and 48th hour.


Eligibility Criteria:
Inclusion Criteria:

* elite soccer players

Exclusion Criteria:

* absent from injuries
* playing less than 70 minutes
Royal Jelly as a Strategy to Modulate Inflammation and Oxidative Stress in Patients With Systemic Arterial Hypertension

The study aims to evaluate the effect of the royal jelly on inflammation and oxidative stress in participants with systemic arterial hypertension. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants for two months.

Royal jelly (RG) is considered a superfood that has been used in traditional medicine and dietary supplementation due to its antioxidant, anti-inflammatory, immunomodulatory, and regenerative properties. The antioxidant and anti-inflammatory effects of GR highlight its potential as a natural supplement for the prevention and management of several health conditions. Although in vitro and animal model data are promising, clinical studies are still needed to validate the effects of royal jelly in human populations.

Eligibility Criteria:
Inclusion Criteria:

* patients using one to three antihypertensive medications, undergoing regular follow-up at the HUAP Medical Clinic for more than 6 months and without the need for changes in medication doses in the last 3 months.

Exclusion Criteria:

* Patients with autoimmune and infectious diseases, diabetes, chronic kidney disease, liver disease, cancer and AIDS will be excluded; pregnant women; those using catabolic drugs or antibiotics; use of antioxidant vitamin supplements, prebiotics, probiotics, symbiotics, habitual intake of royal jelly, and who are allergic to cornstarch or report having an allergy to bee stings will also be excluded. Patients with acute myocardial infarction (AMI) and/or stroke (CVA) in the last 6 months will also be excluded; with HAS stages 2 or 3.
Immune Damage and Vaccination in COPD Patients

Better understanding of the specificities of the vaccine response in patients with COPD

Chronic obstructive pulmonary disease (COPD) will become the third leading cause of death worldwide in 2020 (3.5 million patients, 16500 deaths in France). Its socio-economic cost is related to the handicap induced by the decline of the respiratory function, as well as to the occurrence of exacerbations, main causes of hospitalization and mortality. Since exacerbations are mostly infectious, a preventive strategy involves routine influenza vaccination. Although it is highly recommended in this population, there is no formal evidence of its effectiveness during COPD. While correlates of influenza vaccine efficacy exist, cellular and humoral responses to this vaccine have been poorly evaluated in these patients. This alteration of the vaccine response could also be integrated into an overall deficit of the response to a vaccine in these patients.

As influenza virus infection is one of the most important causes of death in patients with COPD, and vaccination is the best way to prevent it, it is essential to better understand the immune response in the context of vaccination in this population. The investigator's hypothesis is that there would be a global alteration of the immunological immune response in the COPD patient involving abnormalities of lymphocyte B differentiation and the effector capacity of T lymphocytes, notably through the activation of the PD1 / PDL1 axis.

Eligibility Criteria:
Inclusion Criteria:

* Acceptance to participate in the protocol
* Affiliated to a social security scheme
* Age between 40 and 65 years COPD patients
* Diagnosis of moderate to very severe COPD with FEV1 / FVC \<0.7 and FEV1 \<80% of predicted value, cumulative smoking greater than 10PA
* Indication reminder dTP pertussis when the last booster \<5 years Patients without COPD
* FEV / FVC\> 0.8
* Indication reminder dTP pertussis when the last booster \<5 years
* Indication and patient's wish for an influenza vaccination

Exclusion Criteria:

* Refusal to participate in the study
* Progressive cancer and / or treated in the last 5 years, uncontrolled heart failure, connective tissue disease, inflammatory disease of the digestive tract during treatment.
* Exacerbation or any upper or lower respiratory infection in the previous month.
* Any cause of immunodepression, including long-term oral corticosteroids.
* Pregnant or lactating woman
A Prospective Blinded Randomized Study Comparing Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-y Gastric Bypass and Their Effect on Gastro-Esophageal Reflux Disease Using 24 Horus pH Monitoring

Obesity has become a significant health problem in Canada. It is known to be a risk factor for many diseases, including Gastro-Esophageal Reflux Disease (GERD). When medical efforts to lose weight fail, patients often consider bariatric surgical procedures as the next step. The two most common bariatric procedures performed are Roux-en-Y Gastric Bypass (LRYGB) and Laparoscopic Sleeve Gastrectomy (LSG). The gold standard for diagnosing GERD is Esophageal pH monitoring, as it is the most objective method to document the reflux, assess the severity and monitor the response to treatment of the disease. In the last few years LSG has gained in popularity due to its simplicity and short operative time. Currently the comparison between bariatric surgery and GERD symptoms is very one sided. There are significant numbers of studies with conclusive results that state that LRYGB has a positive effect on GERD symptoms, however there is little evidence that states the same about LSG. This means that the relationship between LSG and GERD is inconclusive. An objective evaluation of GERD using 24 hour pH monitoring and validated CRFs at different follow up time points will contribute greatly to our understanding of what this relationship might be.


Eligibility Criteria:
Inclusion Criteria:

* Fulfilled criteria for bariatric surgery as coined by National Institutes of Health conference.
* Their age is ≥18 years and ≤70 years
* The group with symptoms of GERD needs to have diagnosis of GERD in their medical record and taking proton pump inhibitors on a daily basis.
* Able and willing to give written consent
* The patient is willing to perform the pre-operative tests required for this study.
* The patient fits for both surgeries - LSG or LRYGB

Exclusion Criteria:

* Previous bariatric surgery
* Previous anti reflux procedure
* Contra-indication to general anesthesia
* Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
* Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)
* Hiatal hernia above 4cm (measured in the pre-operative gastroscopy).
* Multiple surgeries in abdominal cavity or previous small bowel disease/resection
* Patient on CPAP treatment for his OSA disease
Milrinone During Living Donor Hepatectomy

Maintaining a low central venous pressure during living donor hepatectomy is routine practice. The investigators tried to test the hypothesis that using milrinone to maintain a low central venous pressure (CVP) during is associated with a superior surgical field and less blood loss.


Eligibility Criteria:
Inclusion Criteria:

* Living liver donors

Exclusion Criteria:

* Donors with concurrent cardiac, pulmonary, and urologic disease
* Hepatectomy performed laparoscopically
Platelet Function in Hemodialysis Patient

The objective is to evaluate the function of the platelet in patients undergoing hemodialysis. The investigators will use the assay called PFA-100, an in vitro whole blood assay with three pathways of platelet activation to describe a platelet response profile.

The hypothesis is that patients undergoing hemodialysis present a platelet dysfunction, that may be reversed by hemodialysis. The effect of heparin, used during hemodialysis session to anticoagulate the hemodialyzer, on platelet function will be assessed.

The aim of this study is to evaluate the platelet function during hemodialysis. One hundred patients with end-stage renal disease undergoing hemodialysis (2 to 3 sessions per week, 3 to 4 hours per session) will be included.

Patients who meet the inclusion criteria will be included after oral and written information and signature of written consent.

The study consists in recording clinical and biological and the evaluation of platelet function by the PFA-100 assay. This is a whole blood platelet function assay, with 3 pathways of platelet activation (collagen-epinephrine, collagen-ADP and specific P2Y cartridge - Innovance®).

Whole blood is collected in the arterial line of the arteriovenous vascular access (fistula or graft) before and after the hemodialysis session.

PFA-100 is assayed within 2 hours after blood collection and the platelet response profile is interpreted according to the manufacturers instructions.

Clinical informations, especially hemorragic and thrombotic history, are collected the day of inclusion and 6 months after inclusion.

Eligibility Criteria:
Inclusion criteria :

patient with end-stage chronic kidney disease undergoing hemodialysis age ≥ 18 years old hemodialysis on a peripheral vascular access (arteriovenous fistula or graft) hematocrit between 0.35 and 0.50 and platelet count between 150 and 500 G/L written consent after oral and written information

Exclusion criteria :

pregnancy, breast feeding legal guardianchip hemodialysis on a catheter inability to sign the consent
Randomized Study for the Assessment of Silibinin (Legalon® SIL) in the Treatment of naïve Genotype 4 Patients With Chronic Hepatitis C

The purpose of this study is to explore whether silibinin plus ribavirin with/without peg-interferon can be more effective than the peg-interferon plus ribavirin based standard of care (SoC) in the treatment of patients infected with hepatitis C virus genotype 4.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be willing to give written informed consent
* Male and female patients; age between 21 and 45 years inclusive
* Chronic hepatitis C infection with genotype 4 confirmed by genotypic testing at screening or within 6 months of screening period
* Patients eligible to be treated with RBV and Peg-IFN as per the instructions present in their prescribing information documents
* No history of prior interferon therapy (treatment naïve)
* Detectable HCV-RNA levels
* Normal BUN and creatinine
* Ability to communicate, participate, and comply with the requirements of the entire study

Exclusion Criteria:

* Liver transplant patients
* Co-Infection with HIV and/or HBV
* ALT \>10-fold the upper limit of normal i.e. \> 400 U/L
* Evidence of hepatocellular carcinoma (HCC)
* Fibroscan® at screening with a score ≥ 14.5 kPa
* Evidence of liver disease due to causes other than chronic HCV infection
* Evidence of poorly controlled diabetes (defined as HbA1c \> 8%)
* History of alcohol or drug abuse within the last 12 months
* History or clinical evidence of liver decompensation, e.g. presence of ascites or encephalopathy, or bleeding from esophageal varices
* Serum albumin levels \< 3.2 g/dL
* INR \> 1.3 N
* Total Bilirubin levels \> 2.0 mg/dL unless explained by Gilbert's disease
* Platelet Count \< 100,000 µL
* Absolute Neutrophil counts \< 1500 µL (mm3)
* Active or suspected non-hepatic malignancy or history of malignancy within the last 5 years
* Body Mass Index \< 16 or \> 35 kg/m2
* Females of childbearing potential:

  * Pregnancy (i.e. positive urine pregnancy test at screening) or lactation
  * Failure to agree to practice adequate contraception methods (e.g. oral contraceptives, intra-uterine device (IUD), transdermal contraceptive patch)
* Male patients not vasectomized, who do not agree to abstain from intercourse or who do not use a condom
Safety and Efficacy of BFH772 in Psoriasis Patients

This study will determine the efficacy of topical BFH772 in psoriasis patients and the safety after multiple dosing.


Eligibility Criteria:
Inclusion Criteria:

* Stable mild to moderate plaque psoriasis (BSA involvement \< 10% or PASI \< 10
* Category "mild to moderate" on PGA as according to the EMEA (CHMP 2004) (Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis), with or without arthritis
* Diagnosed or history of psoriasis for at least 6 months prior to screening

Exclusion Criteria:

* Nonplaque forms of psoriasis
* Drug-induced psoriasis
* Current use of beta blockers
* Congestive heart failure (NYHA \>III), QT interval \>450msec or poorly controlled diabetes mellitus

Other protocol-defined inclusion/exclusion criteria may apply