cyrilzakka/clinical-trials huggingface dataset:
Nutrition Therapy in the Immature Infant (ImNuT)

The primary objective of this double-blind randomized study is to assess the effects of an early, enhanced supply of the essential fatty acids (FAs) arachidonic acid (ARA) and docosahexaenoic acid (DHA) on brain maturation, clinical outcomes and quality of growth in immature infants (gestational age \<29 weeks) as compared to standard nutrient supply.

This is a double-blind randomized study. 172 preterm infants with gestational age \< 29 weeks will be enrolled. The intervention group will receive enteral supplementation with essential fatty acids, arachidonic acid (ARA) and docosahexaenoic acid (DHA). The control group will receive standard supplementation with medium-chain triglycerides (MCT-oil). The main hypothesis is that early, enhanced supply of ARA and DHA will improve brain growth and maturation, as compared to standard nutrient supply. Secondary hypotheses are that early, enhanced supply of ARA and DHA will improve quality of growth and cognitive development as well as reduce the frequency of inflammation-related neonatal comorbidities and long-term cardiovascular disease risk. Primary endpoint will be assessed by magnetic resonance imaging (MRI) of the brain at term equivalent age.

Eligibility Criteria:
Inclusion Criteria:

* Extremely preterm infants born at Oslo University Hospital (OUH)
* Gestational age (GA) \< 29 weeks
* Less than 48 hours of age at inclusion
* Signed informed consent and expected Cooperation of the patients for the treatment and follow up must be obtained and documented according to good clinical practice (GCP) and national/local regulations

Exclusion Criteria:

* Major congenital malformations which will affect growth and development
* Chromosomal abnormalities and other genetic diseases
* Critical illness with short life expectancy as defined by the study physician
The Metformin-FMD Trial

In acute myocardial infarction early restoration of coronary blood flow is the most effective strategy to limit infarct-size. Paradoxically, reperfusion itself also aggravates myocardial injury and contributes to final infarct size, a process termed 'reperfusion injury'. Ischemia and reperfusion (IR)-induced endothelial dysfunction seems to play a pivotal role in this process, resulting in vasoconstriction and reduced blood flow to the already ischemic tissue. Recently, it has been shown that the glucose-lowering drug metformin is able to limit IR-injury in murine models of myocardial infarction, probably by increased formation of the endogenous nucleoside adenosine. In the current research proposal, the investigators aim to translate this finding to the human in vivo situation, using flow-mediated dilation (FMD) of the brachial artery as a well-validated model of (endothelial) IR-injury.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-50 years
* Written informed consent

Exclusion Criteria:

* Smoking
* Hypertension (in supine position: systolic BP \> 140 mmHg, diastolic BP \> 90 mmHg)
* Hyperlipidaemia (fasting total cholesterol \> 5.5 mmol/L or random \> 6.5 mmol/L)
* Diabetes Mellitus (fasting glucose \> 7.0 mmol/L or random glucose \> 11.0 mmol/L)
* History of any cardiovascular disease
* Concomitant use of medication
* Renal dysfunction (MDRD \< 60 ml/min)
* Professional athletes
The Use of Nesiritide in Thoracic Aneurysm Repair to Prevent Acute Renal Failure

The purpose of this trial is to study the use of nesiritide in thoracic aneurysm repair to prevent acute renal failure.

The study hypothesis: Nesiritide, given prophylactically prior to surgery may prevent acute renal failure requiring dialysis and/or decrease mortality.

Acute renal failure is a major and serious complication of more than 200,000 cardiovascular surgeries performed on adult Americans annually (www.sts.org). The incidence of acute renal failure (ARF) after cardiac surgery (depending on criteria used to define ARF) is 1-5%, in the absence of preexisting renal dysfunction. The subset of patients with thoracic aortic aneurysm surgery have a higher risk for the development of postoperative ARF (25-40% - ARF defined as doubling of serum creatinine; 13% - ARF defined as requirement for dialysis). This risk is further increased by various peri-operative factors, especially cardiopulmonary bypass time.

The overall postoperative mortality rate for cardiovascular surgery is 2.2%, but is much higher for thoracic aortic aneurysm surgery (8-10% for elective repair, 25-50% for ruptured thoracic aorta aneurysm repair). The major risk factor for thoracic aortic aneurysm surgery related mortality is post-operative ARF requiring dialysis. When thoracic aortic aneurysm surgery is complicated by acute renal failure, the mortality rate worsens to 50%. Thus, identifying ways to prevent acute renal failure may have a major impact on the outcome of cardiovascular surgery. A retrospective study of the use of nesiritide in cardiovascular surgery patients by our group has demonstrated a tendency towards a decreased incidence of renal failure and mortality, when the medication is used prophylactically.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Undergoing thoracic aortic aneurysm surgery
* Impaired renal function

Exclusion Criteria:

* Prior history of allergy/adverse reaction to Nesiritide
* History of any organ transplant
* Preoperative intra-aortic balloon pump (IABP)
* Decompensated congestive heart failure (CHF)
The Value of Artificial Intelligence-based 18F-FDG PET/CT in Diferential Diagnosis, Efficacy Prediction and Prognosis Prediction of T-NK Cell Lymphoma: a Clinical Study

Based on the PET/CT imaging data of patients with T-NK cell lymphoma, machine learning and deep learning methods are used to extract imaging features, establish a T-NK cell lymphoma prediction model, and provide more scientific and accurate prognosis prediction for the clinic.

This study adopts a multicenter retrospective cohort study design，we provided PET/CT of 200 patients with T-NK cell lymphoma as an external validation set for model validation.

Eligibility Criteria:
Inclusion Criteria:

1. Pathological histology confirmed as T-NK Cell Lymphoma; 2.18F-FDG PET/CT examination before treatment; 3. Using modern best practice treatment options; 4. Complete clinicopathological and follow-up data were obtained.

Exclusion Criteria:

1. The patient had previously received antitumor therapy;
2. The patient had a history of other tumors;
3. Incomplete clinical information or imaging data;
4. Concomitant other malignant tumors.
Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo

The purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea during long-term treatment with either Oracea® or placebo, after an initial 12-week regimen of Oracea® and MetroGel® 1%.

Adult subjects with moderate to severe papulopustular rosacea will receive Oracea® and MetroGel® 1% once daily during phase 1 (baseline to week 12) of the study. Subjects will be eligible to enter phase 2 of the study based upon improvements in the Investigator's Global Assessment (IGA) score. During phase 2, subjects will receive either Oracea® or placebo once daily for up to an additional 40 weeks. Subjects who relapse during phase 2 will be discontinued from the study.

Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female aged 18 to 80 years inclusive.
* Subject with papulopustular rosacea (11 to 40 papules or pustules) and an IGA of moderate or severe.
* For subjects using medications to treat a concurrent medical condition, type and dose must have been stable for at least 90 days prior to study entry.

Exclusion Criteria:

* Female subjects who are pregnant, nursing or planning a pregnancy during the study.
* Subject has any other active dermatological condition on the face that may interfere with the conduct of the study.
* Subject uses or has recently used any medication which may interfere with the absorption, distribution, or elimination of study medications, or may interfere with the assessments of efficacy or safety of the study medications.
* Subject has a known allergy to any of the components of the study products, and/or a known hypersensitivity to tetracyclines or metronidazole.
Colonoscopy Using Nitrous Oxide- A Pilot Study in the USA

Colon cancer is the second most common cancer in men and the third most common cancer in women worldwide. The clinical objectives of administering sedation for GI endoscopy are to relieve patient anxiety and discomfort and to improve the outcome of the examination. Use of N2O could potentially provide an alternate safe and cheap option for patients who do not prefer IV sedation for colonoscopy

Patients who are considered low risk for anesthesia administration (ASA class \<IV) receive moderate sedation with a combination of intravenous benzodiazepine and opioid medication. an alternative method of providing analgesia with "on-demand" inhalation of nitrous oxide (hereafter referred to as N2O) combined with oxygen has been postulated. Nitrous Oxide has been used for analgesia in various procedures including childbirth, general anesthesia, pediatric dentistry, bone marrow aspiration, fracture reductions, and minor surgical procedures (surgical dressings, pulmonary endoscopy, an abscess . It could potentially reduce overall costs for the procedure, in addition to providing a quicker recovery, turn over

Eligibility Criteria:
Inclusion Criteria:

Men and women, more than 18 years old Scheduled for a colonoscopy at the Endoscopy unit

Exclusion Criteria:

* High ASA risk (IV/ \>)
* History of chronic pain
* Allergy to N2O or opioid or BDZ
* No consent
* Recent head injury with impairment of consciousness or Intracranial / Middle Ear surgery within the previous 6 months with or without residual deficits.
* Pneumothorax, air embolism
* Decompression sickness or within 48 hours of an underwater dive
* Severe emphysema with bullae
* Gross abdominal distension with suspicion for bowel obstruction
* Intoxication
* Maxillofacial injuries (where patient unable to administer the drug using a mouthpiece/mask, or there is the risk of causing further damage to facial wounds and there may also be a significant risk of blood inhalation)
* Patients with chronic pulmonary disease for whom an inspired oxygen concentration of more than 28% oxygen might be dangerous
* Patients on Methotrexate
* Where patients need assistance to hold the mask or mouthpiece.
* Retinal surgery within the last three months
* Any patient who does not otherwise clinically qualify for standard sedation methods (i.e., those who require general anesthesia)
Timolol Gel for Epistaxis in Hereditary Hemorrhagic Telangiectasia

This study is a double-blinded, randomized controlled trial to evaluate the efficacy of an intranasal topical timolol gel in the care for epistaxis in adults with hereditary hemorrhagic telangiectasia.

This study is a double-blinded, placebo-controlled, 8-week randomized clinical trial investigating the efficacy of timolol gel in the management of epistaxis in adults with HHT.

The Specific Aims are to determine in adults with HHT-associated epistaxis:

1. If topical timolol gel is more effective than placebo in reducing the frequency and severity of epistaxis.
2. If topical timolol gel is more effective than placebo in improving hemoglobin levels.
3. The frequency of adverse events, side effects, and safety profile of topical timolol gel delivered to the nasal mucosa.

Eligibility Criteria:
Inclusion Criteria:

1. Adults ages 20 and older
2. Confirmed clinical (meeting at least 3 of the 4 Curaçao Criteria) or genetic diagnosis of HHT
3. Epistaxis Severity Score (ESS) ≥ 4 and 2 or more nosebleeds per week with a cumulative nosebleed duration of at least 5 minutes per week
4. Stable nasal hygiene and medical regimen for preceding 1 month
5. Stable epistaxis pattern over the preceding 3 months

Exclusion Criteria:

1. Contraindications for systemic β adrenergic blocker administration

   1. Hypersensitivity to β adrenergic blockers
   2. Asthma or bronchospasm
   3. Congestive heart failure with LVEF \<40%
   4. Hereditary pulmonary arterial hypertension
   5. Baseline bradycardia (HR \<55 beats per minute)
   6. Sick Sinus Syndrome
   7. 2nd or 3rd degree heart block, left or right bundle branch block, or bifasicular block
   8. Uncontrolled diabetes mellitus (most recent HbA1c \>9%) or diabetic ketoacidosis within last 6 months
   9. Hypotension (systolic blood pressure \< 90)
2. Known hypersensitivity to timolol
3. Severe peripheral circulatory disturbances (Raynaud phenomenon)
4. Known intermediate or poor metabolizer variant of the liver enzyme CYP2D6
5. Current use of any of the following known strong CYP2D6 inhibitors: fluoxetine (Prozac), paroxetine (Paxil), bupropion (Welbutrin), quinidine, quinine, ritonavir (Norvir), and terbinafine (Lamisil)
6. Current use of the following other drugs known to pharmacodynamically interact with timolol: diltiazem, verapamil, digoxin, digitalis, propafenone, disopyramide, clonidine, flecainide, or lidocaine
7. Patients currently treated or who plan to initiate treatment with β-blockers
8. Use of any anti-angiogenic medication in the last month prior to recruitment, including bevacizumab, pazopanib, thalidomide, or lenalidomide
9. Illicit drug use, except marijuana
10. Known pheochromocytoma
11. Use of anticoagulants, antiplatelet, or fibrinolytic therapies within the last month prior to recruitment, except for low-dose (81 mg or less) of aspirin
12. Pregnancy or planned pregnancy in the next 6 months or currently breastfeeding
13. Inability to read or understand English
14. Inability to complete 8 weeks of therapy for any reason
Assessment of Gait Parameters and Their Impact on Postoperative Recovery in Patients with Lumbar Spinal Stenosis

The objective is to observe the evolution of walking parameters during the surgery process and find which of all calculated walking parameters represent the best indicators of functional disabilities and postoperative recovery for patient with lumbar spinal stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lumbar spinal stenosis
* Presenting neurogenic claudication
* Waiting for a surgery (laminectomy, laminotomy, fusion)

Exclusion Criteria:

* Symptomatic hip or knee osteoarthritis
Autologous EBV-specific Cytotoxic T Cells for the Treatment of Systemic Lupus Erythematosus (SLE)

EBV has been implicated in pathogeny of SLE with increase in EBV sero-prevalence, defective control in EBV infection and altered both B and T immune responses to this virus The main objective of this pilot proof-of-concept (POC) study is to evaluate safety and efficacy of autologous EBV specific CTL adoptive transfer in adult patients with serologically active SLE

Systemic lupus is a disabling disease of the young woman, whose treatment is based on the long-term corticosteroid, anti-malarials and immunosuppressants synthesis. This support is not without potential side effects. EBV is a herpes causes infectious mononucleosis virus, usually encounter in childhood or adolescence, and that our natural immunity cell (CD8 T cells) controls all our lives, not eliminate.

Increasingly scientific studies show that there are patients with systemic lupus (and multiple sclerosis), a failure of self-control of the EBV virus, by T lymphocytes (CD8). This uncontrolled virus then stimulate the B lymphocytes, which produce antibodies, toxic in lupus. The laboratory isolate T cells specific for EBV (EBV-CTL) of a patient, and stimulate in culture to strengthen them. They can be then re-injected by a single intravenous infusion (autotransfusion), and were used to control the virus in certain diseases where EBV has a demonstrated role post-transplant lymphoproliferative disorder, chronic fatigue syndrome EBV-induced.

Our therapeutic approach is completely innovative, as based on the principle of cell therapy, thus not using new drugs, and based on the restoration of the patient's immune system, specific EBV.

Eligibility Criteria:
Inclusion Criteria:

* 4 systemic lupus criteria of the American College of Rheumatology with antinuclear antibodies\> 1:80
* Age greater than or equal to 18 years
* Lupus serologically active without active serious disease (Kidney, CNS)
* Anti-native DNA Ac positive and / or C3 or C4 low
* SLEDAI greater than or equal to 2 at baseline
* Serology HBV, HCV, HIV, HTLV-1, syphilis: Negative J-30 before sample
* Hemoglobin \>11g/dL
* Prednisone dose \<15 mg / day with a stable dose within 30 days previous injection
* Immunosuppressive treatments which dosage has not been increased for at least 3 months before enrollment
* Agreement telephone and / or mail for coordinating investigator inclusion
* Social ensured Patient
* EBV positive serology

Exclusion Criteria:

* Evolving severe lupus, requiring high dose corticosteroids and / or immunosuppressive therapy
* Psychiatric disorders
* Predicted Failure to monitoring compliance with impossibility
* Infectious Episode underway
* Evolutionary Cancer
* Risk of death within 6 months
* Consent Refusal
* Pregnancy
* Nursing women
Filtered Trial for Telmisartan 40mg Non-responder

The primary purpose of this study is to:

Demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to telmisartan 40 mg alone in patients with essential hypertension and inadequately controlled with telmisartan 40 mg monotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Essential hypertensive patients who satisfying non-responder criteria
2. Male or Female
3. Age 20 years or older
4. Outpatient

Exclusion Criteria:

1. Taking four or more anti-hypertensive medications
2. Secondary hypertension
3. Mean seated diastolic blood pressure (DBP) \> 114 mmHg and/or mean seated systolic blood pressure (SBP) \> 200 mmHg at Visit 1, 2, 3, or 4, or mean seated DBP \< 90 mmHg at Visit 3.
4. Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias
5. Congestive heart failure patients with the New York Heart Association (NYHA) functional class III-IV
6. History of myocardial infarction or cardiac surgery within last 6 months
7. History of coronary artery bypass graft or percutaneous coronary intervention (PCI) within last 3 months
8. History of unstable angina within last 3 months
9. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve
10. History of stroke or transient ischemic attack within last 6 months
11. History of sudden exacerbation of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors, or patients with post-renal transplant or post-nephrectomy
12. Experienced characteristic symptoms of angioedema during treatment with ARBs or ACE inhibitors
13. Known hypersensitivity to any component of the investigational drug , or a known hypersensitivity to dihydropyridine -derived drugs
14. Hepatic and/or renal dysfunction
15. Diagnosed biliary atresia or cholestasis
16. Hyperkalemia
17. Dehydration
18. Sodium deficiency
19. Chronic administration of high doses of acidic nonsteroidal anti-inflammatory drugs (NSAIDs)
20. Patients who cannot change to the restricted administration and dosage during study period
21. Pre-menopausal women who meet any one of the following 1 - 3:

    * Pregnant or possibly pregnant (1)
    * Nursing (2)
    * Desire to become pregnant during study period (3)
22. Drug or alcohol dependency
23. Complication of malignant tumour or a disease requiring immunosuppressants
24. Compliance of \< 80% or \> 120% during the run-in period
25. Receiving any investigational therapy within 3 months
26. Judged to be inappropriate by the investigator or the sub-investigator
Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence

The main objective of the BREIZH-Cohorte study is to determine the incidence of recurrent short, medium and long-term thromboembolic venous disease as well as risk factors for recurrence in two specific populations: patients under 50 years of age, men and women (5 year recurrence), as well as cancer patients (all ages) (1 year recurrence).

Deep vein thrombosis (DVT) and pulmonary embolism (PE) are two clinical manifestations of the same entity, thromboembolic venous disease. This disease is frequent: the annual incidence of thromboembolic venous disease estimated between 1 and 2 cases per 1000 inhabitants per year in France, comparable to that observed in North America. This disease is potentially serious: the mortality from PE, the most severe manifestation of thromboembolic venous disease (one third of PE for two thirds of DVT) is 10% at 3 months, twice as high as that of myocardial infarction. However, the risk of PE in isolated DVT is major (more than 50% of cases). Thus, whether it is a PE or a DVT, anticoagulant treatment, a cornerstone of therapeutic management, must therefore be initiated urgently, without waiting for the results of diagnostic confirmatory examinations.

The major complications occurring after a thromboembolic venous disease are venous thromboembolic recurrence (VTE) and the long-term consequences: post-thrombotic syndrome and the development of post-embolic pulmonary hypertension. VTE recurrence has significant mortality, particularly in the form of PE (15%, compared to 2% in the form of DVT). As for long-term complications of VTE, about 20-30% of patients with DVT develop post-thrombotic syndrome at 5 years (27), while 0.15% to 5% of patients with PE develop post-embolic pulmonary hypertension at 1 year.

While major progress has been made over the past 20 years in terms of diagnosis, primary and secondary prevention, identification of risk factors for VTE and prognostic factors, however, two particular subgroups deserve to be specifically investigated: young subjects, whether women (hormonal exposure) or men (often idiopathic thromboembolic venous disease), and cancer patients. In the latter, the progress made on anti-cancer treatments is helping to modify the data on the risk of VTE as well as the duration of treatment of VTE in these patients.

Thus, this prospective cohort covers two subgroups of patients with thromboembolic venous disease: young subjects (≤50 years) or those who have cancer.

Eligibility Criteria:
Inclusion Criteria:

* Subject aged 18 or over, or a minor with the consent of the parents and the minor, presenting with a thromboembolic venous disease
* 50 and under or any age if active cancer
* Affiliated to social security
* Accepting to participate in the study.

Exclusion Criteria:

* Foreign nationality.
* Inability to communicate (comprehension disorder).
* Refusal to participate.