cyrilzakka/clinical-trials huggingface dataset:
Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer

This pilot clinical trial studies low-dose acetylsalicylic acid in treating patients with stage I-III non-small cell lung cancer. Studying samples of urine and blood from patients with cancer in the laboratory may help doctors learn more about changes in biomarkers that occur during treatment with acetylsalicylic acid

PRIMARY OBJECTIVES:

I. To determine whether ASA (acetylsalicylic acid) 325 mg inhibits prostaglandin E2 (PGE2) biosynthesis in patients with early stage non-small cell lung cancer (NSCLC). Cyclooxygenase (COX) catalytic activity will be determined by measuring the metabolite of PGE2, 11alpha-hydroxy-9,12-dioxo-2,3,4,5-tetranor-prostane-1,20 dioic acid (PGE-M) in urine pre- and post-ASA 325 mg as a surrogate of systemic PGE2 biosynthesis.

SECONDARY OBJECTIVES:

I. To determine whether COX-2 protein has a slow turnover in adenocarcinoma of the lung. COX turnover will be determined by measuring urinary PGE-M levels daily for 7 days after discontinuing ASA 325 mg. COX-2 and Prostaglandin expression will also be measured in tumor samples of patients taken at the time of surgery.

OUTLINE:

Patients receive acetylsalicylic acid orally (PO) for 7 days and urine is collected for 7 days post therapy.

Eligibility Criteria:
Inclusion Criteria:

* Have confirmed (stage IIIb-IV) or recurrent non-small cell lung cancer, adenocarcinoma histology
* Understand and voluntarily sign an informed consent document prior to any study related assessments or procedures are conducted
* Anticipated that they will complete all study procedures
* Ability to swallow pills
* No aspirin in the last 7 days

Exclusion Criteria:

* Know allergy to aspirin or other nonsteroidal anti-inflammatory drugs
* History of allergic reaction to aspirin or other non-steroidal anti-inflammatory drugs, including ibuprofen
* Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety
Maternal Care Bundle to Attenuate Hypotension in Cesarean Section

Cesarean Section (CS) is a common obstetric surgery that can be performed by both general or regional anaesthetic techniques. Hypotension is the most common complication of spinal anaesthesia, its incidence varying from 70% to 80 %, if severe, it can result in serious perinatal adverse outcomes, such as maternal nausea and vomiting, fetal acidosis and may be an important contributory factor for maternal death related to regional anaesthesia.

A variety of methods have been used for the prevention of post-spinal hypotension which includes the use of intravenous fluid, vasopressors, and physical methods such as table tilt, leg binders, and compression devices. However, a single technique is ineffective and a combination of interventions is suggested.

A care bundle is a group of three to five evidence-based interventions that, when performed together, have a better outcome than if performed individually. A care bundle consists of a group of (usually) between three and five evidence-based interventions. These are related to a particular condition or event for patient care.

Care bundles are well known in the field of intensive care medicine such as Ventilator-Associated Pneumonia (VAP) care bundle, sepsis care bundle, and Central Line-Associated Bloodstream Infection (CLABSI) care bundle.

To our knowledge, till now, no one has investigated a special care bundle in the field of anaesthesia.

In this work, we will investigate the safety and efficacy of a special care bundle in controlling spinal induced hypotension.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 21 years old and less than 40 years.
* Patients are ASA I (American Society of Anesthesiology physical status Grade I) = (normal healthy patients) or ASA II (American Society of Anesthesiologists physical status Grade II) = (patients with mild systemic disease and no functional limitations).
* None laboring, at term with singleton uncomplicated pregnancies.
* Delivery under spinal anesthesia, with height 150 to 180 cm
* Body mass index of at most 40 kg/m2.

Exclusion Criteria:

* Parturient with peri-partum disorders as DM, HTN, cardiac diseases, bronchial asthma or bleeding disorders
* Obesity: BMI \>40
* Any known allergy to local anesthetic drugs or ondansetron.
* Apparent anatomical abnormalities or infections in the back region.
* Bleeding disorders e.g., thrombocytopenia, high INR, high PT in the chronic liver or impaired kidney).
* Refusal to participate in the study
Early Diagnosis of Mycosis Fungoides

Mycosis fungoides (MF) is an epidermotropic cutaneous T cell lymphoma characterized by the accumulation of CD4+ T-lymphocytes in the skin. Early MF presents as erythematous patches and/or infiltrated plaques. The diagnosis of early MF is a major diagnostic challenge and the differential diagnosis with inflammatory dermatoses is often very difficult. The histopathological diagnosis is also difficult and delayed. Therefore, it is important to develop biomarkers and/or a combination of biomarkers in order to improve the early diagnostic of MF.

In a previous trial, investigators included 490 patients in a study aiming at identifying skin biomarkers of early MF. Several activating and inhibiting KIRs were found to be interesting for the skin diagnostic of MF, mainly KIR2DL4 and KIR3DL2. Investigators later evaluated blood biomarkers in patients with erythrodermic MF and Sezary Syndrome (SS). This French institutional study demonstrated that the identification by PCR of a combination of 4 blood markers (CD158k/KIR3DL2, PLS3/T-Plastin, Twist and NKp46) allowed a reliable diagnosis of lymphoma in erythrodermic patients. This previously published study interestingly showed that 30% to 50% of patients with early MF expressed at least one of these biomarkers in the blood (unpublished data). Other groups also recently showed that TOX can be a diagnostic tool for MF.

The aim of this study is to establishing an accurate blood diagnosis for early suspected MF by demonstrating that newly identified biomarkers or their combination \[5 cutaneous KIR receptor markers (KIR2DS1, KIR2DS3, KIR3DL1, KIR2DL4, KIR3DL2) and 5 blood biomarkers (TOX, Twist-1, PLS3/T-plastin, KIR3DL2, NKp46)\] are differentially expressed by patients with MF and patients with inflammatory dermatoses closely resembling MF lesions.

Statistical analysis will establish the best combination of blood biomarkers allowing the differentiation between the two groups of patients, combination that could represent a suitable diagnostic tool for early MF.


Eligibility Criteria:
Inclusion Criteria:

* Patients with erythematous dermatitis of subacute evolution (\> 15 d) or chronic evolution, in the form of patches/plaques, leading to a clinically suspected cutaneous T cell lymphoma
* Free and informed consent signed
* Erythematous dermatosis, sub-acute (\> 15 days) or chronic, suspicious of MF
* Lack of previous hemopathy or cutaneous or extra-cutaneous lymphoma
* Age \> 18 years
* A skin biopsy for routine diagnostic histopathological analysis at the time of inclusion
* With an analysis of T-cell clonality in blood and skin at the time of inclusion

Exclusion Criteria:

* Children under 18 years
* Sick adults under guardianship
* Patients refusing to participate in the research protocol
* Subjects not affiliated with the national health insurance system.
Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain

Neuropathic pain is due to a lesion or disease affecting the nervous system. Antidepressants (ADs) are recommended as the first line treatment. In a murine model, the investigators evidenced that antidepressants antiallodynic action is mediated through β2-adrenergic receptor stimulation and that β-mimetics display the same effect. These data support the idea that β-mimetics could offer a therapeutic alternative to ADs for neuropathic pain treatment. This study will aim at assessing the effects of terbutaline on neuropathic pain symptoms.


Eligibility Criteria:
Inclusion Criteria:

* adults from 18 to 75 years old
* neuropathic painful condition following a thoracotomy or thoracoscopy for at least 3 months

Exclusion criteria:

* cardiovascular risk
* unstable diabetes mellitus
* allergy for terbutaline
* hypokaliemia without treatment
* untreated hypothyroidism
* HIV- or chemotherapy-induced neuropathy
* cancer being treated by chemo- or radio-therapy
* concomitant treatment with β-blockers, tricyclic ADs or morphine
* concomitant pain more severe than neuropathic pain- pregnant women
PF-04191834 Single Dose Bronchodilatory Study In Asthma.

Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma


Eligibility Criteria:
Inclusion Criteria:

* Persistent mild/moderate asthma for at least 6 months.
* Reduced lung function
* Reversible airway obstruction

Exclusion Criteria:

* Pregnant/nursing females.
* Liver function tests greater than upper limit of normal (ULN)
NHF vs. COT in Hypoxemic Pandemic Viral Illness

The study compares oxygen and NHF in patients with acute viral illness. The duration will be 72h. After them physiological parameters and the outcome will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* acute hyperemic viral illness
* acute hyperemic or hypercapnia respiratory failure

Exclusion Criteria:

* intubation criteria
* indication for NIV therapy
* influences of primary endpoint (rip fracture, lung embolism)
* tracheostomy
* other interventional trials
* noncompliance
DBS in Treatment Resistant Major Depression

This study aims at assessing efficacy and safety of DBS for treatment of patients suffering from resistant major depression, by means of a random, controlled and crossed study.

The first phase of the study will consist of implanting electrodes and applying continuous stimulation until the patients stabilise clinically. This period is anticipated between 6 and 9 months. The next phase will consist of the crossover study. Responders will be randomised to either of 2 groups for a period of 3 months: a stimulation-on group and a stimulation-off group. Patients will then be crossed over to the other group for a further 3 months. Fortnightly visits will be made during the entire study to evaluate treatment efficacy and patient tolerance

Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes aged between 18 and 70 years.
2. Patients diagnosed as having an MDD episode according to DSM-IV-TR criteria, resistant to pharmacological treatment with a score of 4 in the Thase-Rush index, with ECT contraindicated or having failed to produce a maintained response.
3. Patients with a HRSD-17 score of 18 or more.
4. Patients with an intellectual capacity that facilitates adequate communication and who are willing to cooperate with all the examinations and protocols of the study.
5. Patients who have not modified their antidepressant treatment in the month prior to the study.
6. Women of childbearing age using medically approved contraceptive methods.
7. Patients who have granted their informed consent in writing.

Exclusion Criteria:

1. Female patients who are pregnant or breastfeeding.
2. Patients with acute, serious or unstable illnesses.
3. Patients experiencing delirium or hallucinations, congruent or otherwise with their mood.
4. Patients with a history of substance abuse (other than tobacco or caffeine).
5. Patients with concomitant psychiatric disorders from axes I or II of DSM IV-TR.

h)Patients with general contraindications for DBS (pacemaker users, etc).
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action

Obesity prevalence in persons with T1D has increased, which further complicates management and risk for complications. The proposed study is relevant to public health because it helps us understand the role of the gut microbiome in disease pathophysiology in T1D youth with obesity as well as potential mechanisms to modify disease.


Eligibility Criteria:
Inclusion Criteria:

1. Obese youth 11-18 years of age with T1D at time of enrollment.
2. Lean youth 11-18 years of age with T1D at time of enrollment.

Exclusion Criteria:

1. Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and by genetic/antibody testing).
2. History of ongoing infection or antibiotic treatment within the past month;
3. History of immune-compromise, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past 6 months.
4. History of chronic gastrointestinal disease, possible or confirmed celiac disease;
5. Participation in any research intervention trials within the past 3 months.
6. History of treatment or use of metformin, a type 2 diabetes medication.
The Effect of High-flux Hemodialysis and On-line Hemodiafiltration on Endothelial Function.

The main aim of this project is to evaluate, in patients with chronic kidney disease (CKD5D), the role of adhesion molecules in leukocyte adhesion and transendothelial migration involved in atherogenesis. This trial is a prospective randomized crossover study in CKD5D hemodialysis patients followed in the Nephrology Unit of the Reina Sofia University Hospital (Cordoba, Spain). The estimated inclusion period is two years, with a follow-up of 24 months. Patients will be randomized to high-flux hemodialysis versus online hemodiafiltration with high convective transport (above 21 liters); after 6 months in each dialysis modality they will be switched the other technique for another 6 months. Then, patients will be maintained during 4 weeks in conventional hemodialysis "wash out period", before being started in the other dialysis modality.

The main aim of this project is to evaluate, in patients with chronic kidney disease (CKD5D), the role of adhesion molecules in leukocyte adhesion and transendothelial migration involved in atherogenesis. This trial is a prospective randomized crossover study in CKD5D hemodialysis patients followed in the Nephrology Unit of the Reina Sofia University Hospital (Cordoba, Spain). The estimated inclusion period is two years, with a follow-up of 24 months. Patients will be randomized to high-flux hemodialysis versus online hemodiafiltration with high convective transport (above 21 liters); after 6 months in each dialysis modality they will be switched the other technique for another 6 months. Then, patients will be maintained during 4 weeks in conventional hemodialysis "wash out period", before being started in the other dialysis modality. Patients will be stratified by age, gender and the presence of diabetes. Routine analytical determinations (urea, creatinine, sodium, potassium, chlorine, total CO2, calcium, phosphorus, FA, PTH, levels 25OH, β2m, ALT, hemoglobin, leukocytes, platelets, glucose, uric acid, total proteins, albumin , PCR, IL-6, ferritin, TSAT and homocysteine), characteristics of hemodialysis and dialysis dose (Kt / V and Kt) will be recorded. Residual renal function will be analysed every three months. In plasma, microRNAs profile and FGF23 levels will be determined. Markers of endothelial dysfunction (CD31 +, CD41-, CD144, CD62E) and subclinical atherosclerosis markers (CD11b, CD41 +) will be measured. The hospitalization and mortality rate due to cardiovascular causes and concurrent cardiovascular events throughout the study (acute myocardial infarction, stroke, transient ischemic attack and peripheral vascular disease) will be assessed along the study period.

Eligibility Criteria:
Inclusion Criteria:

* Vascular access with a blood flow \> 300ml/min
* Age \>18 \<80 years written informed consent

Exclusion Criteria:

* Neoplasia
* B hepatitis
* Acute or chronic inflammation life expectance less than one year Included in living donor transplant list immunosupressive drugs
A Prospective Cohort Study of China Serum Uric Acid Levels

Uric acid is the final breakdown product of purine degradation in humans. The association between high serum uric acid levels and arterial stiffness as well as endothelial dysfunction has been demonstrated in humans and uric acid has been suggested to be an important modulator of the inflammatory process. But debates still existed for hyperuricemia and hypouricemia as an independent role,especially after controlling other traditional atherosclerotic risk.The aim of this study was, firstly, to verify the association between hyperuricemia and cardiovascular diseases,secondly,to assess whether hypouricemia was an independent risk factor impact for cardiovascular disea.

The study is a longitudinal cohort study. The first cross-sectional survey was conducted in 2011. The eligible participants were followed up from November 2011 to June 2018 (mean follow-up months 68.71±11.35). During the followed-up time, 67 patients had missing data and 56 had no compliance. Thus, the study sample actually comprised 3,047 valid participants (1536 men, 1511 women) whose age older than or equal to 35 years (mean age 60.2±10.4 years) were followed up. A total of hospitalized patients were consecutively enrolled from cardiology department of Beijing and Shanghai. All subjects are under treatment because of cardiovascular diseases.

Eligibility Criteria:
Inclusion Criteria:

age older than or equal to 35 years with multiple classical Framingham risk factors patients.

Exclusion Criteria:

Severe congestive heart failure and Severe renal failure patients.Severe congestive heart failure was defined that above or equal to cardiac functional classify 3 formulated by New York Heart Association (NYHA). Severe renal failure was defined as an estimated glomerular filtration rate \<60 ml/ min/1.73m2.
Effect of Beta Blocker Treatment on Endothelial Function in Patients With Type 2 Diabetes or Chronic Heart Failure

The aim of this study is to evaluate the effect of the two different beta blockers metoprolol and carvedilol on endothelial function in patients with either type two diabetes or chronic heart failure.

Hypothesis: 1\* Carvedilol compared to metoprolol has a favourable effect on endothelial function.

2\* Carvedilol compared to metoprolol has a favourable effect on insulin stimulated endothelial function.

The study is conducted as an open parallel group study. Endothelial function and insulin stimulated endothelial function was evaluated before and after a two months treatment period with either of the two beta blockers.

Endothelial function is deteriorated in patients with type 2 diabetes and in patients with chronic heart failure. Treatment with carvedilol improves survival in patients with chronic heart failure compared to treatment with metoprolol. Carvedilol improves metabolic glucose control in patients with diabetes compared to metoprolol.Carvedilol compared to metoprolol also decreases the number of patients with new onset diabetes among patients with chronic heart failure. The mechanism behind these findings has not been fully understood.

The purpose of this study is to investigate if carvedilol compared to metoprolol has a favourable effect on endothelial function and insulin stimulated endothelial function, in groups of patients with either diabetes or chronic heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Chronic heart failure

Exclusion Criteria:

* For patients with type 2 diabetes:

  \* Vascular complications.
* For patients with chronic heart failure:

  * Severe uncontrolled heart failure.
  * Untreated severe hypertension, hypotension.
  * Bradycardia.
  * Known intolerance to beta blocker treatment.
  * Pregnancy,
Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research

This study will investigate the use of misoprostol for first-line treatment of incomplete abortion at tertiary hospitals in Myanmar.

This open-label feasibility study seeks to examine the potential of 400μg sublingual misoprostol for the treatment of incomplete abortion provided at tertiary hospitals.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed incomplete abortion
2. No known contraindications to the study drug
3. Uterine size no larger than 12 weeks at time of presentation for care
4. No signs of severe infection, defined as at least two of the following:

   * foul smelling discharge,
   * fever \> 38 degrees C, 100 degrees Fahrenheit
   * uterine tenderness.
5. No hemodynamic disturbances (pulse \>110/min and systolic bp \<100)
6. General good health
7. Agree to comply with study procedures including return for follow up visit
8. Live or work within one hour from a study site
9. Willing and able to sign consent forms

Exclusion Criteria:

1. Inability to provide informed consent
Frailty Assessment of Patients With Gastrointestinal Surgery

Patients aged 65 or older under gastrointestinal surgery will be enrolled，the investigators will assess the frailty of these patients by Frailty Index Scale and explore the correlation between the frailty and perioperative adverse events.

Patients will be assessed by specially trained doctors or nurses after admission, including daily living ability, physiological function, social-psychological status, comorbidities, mental state, grip strength, walking speed. After the assessment, the patients' frailty index was obtained. Moreover, the operation time, intraoperative bleeding loss, perioperative complications, length of stay, hospitalization expenses, readmission rate within 30 days, mortality within 30 days and other outcome indicators of these patients will be recorded.

The Main purposes of present study are to verify the feasibility of applying Frailty Index (FI) to assess the degree of frailty in elderly patients undergoing gastrointestinal surgery, compare the difference of perioperative adverse events in elderly patients with different degrees of frailty，find potential indicators for evaluating and predicting the safety of surgery in elderly patients, and provide reference data for the determination of future assessment tools of frailty.

The secondary objective is to compare the quality of life and long-term prognosis(only for patients with cancers,including recurrence free survival and overall survival) of elderly patients with different degrees of frailty after gastrointestinal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose age not less than 65 years;
* undergoing operation in gastrointestinal surgery of West China hospital due to gastrointestinal disease.

Exclusion Criteria:

* Those who did not undergo surgery for various reasons;
* Death before operation
Interaction Study SLV337/Simvastatin

To investigate the effect of multiple doses of SLV337 on the pharmacokinetics of simvastatin and simvastatin acid when co-administered in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Volunteers with Body Mass Index 18.0-28.0 kg/m2

Exclusion Criteria:

* Clinically relevant medical history