cyrilzakka/clinical-trials huggingface dataset:
Metabolism of Omega-3 and Omega-6 During Healthy Aging

The purpose of this study is to determine the kinetics of 13C-eicosapentaenoic acid (EPA) and 13C-arachidonic acid (AA) in young and older participants


Eligibility Criteria:
Inclusion Criteria:

* six young (18-30 y old) and six older (≥ 70 y old)
* healthy non medicated participants.

Exclusion Criteria:

* Tobacco,
* malnutrition (assessed from blood albumin, haemoglobin and lipids), -
* participants taking an EPA+DHA supplements or consuming more than 2 fish meals per week,
* severe gastro-intestinal problems,
* medication for diabetes,
* thyroid disease,
* renal failure,
* cancer,
* psychiatric difficulties or depression,
* cardiovascular disease,
* glucose intolerance (\>8 mmol/L in fasted samples)
* chronic immune condition or inflammation (CRP \> 10 mg/l, white cell count),
* recent major surgery or cardiac event,
* dementia,
* ongoing or past severe drug or alcohol abuse,
* ongoing or past intensive physical training.
Drug-Eluting Bead, Irinotecan Therapy for Unresectable Intrahepatic Cholangiocarcinoma w/Concomitant Gemcitabine and Cisplatin or Carboplatin

The purpose of this study is to find out if the combination of trans-arterial chemoembolization (LC or ONCOZENE BEAD) plus infusional chemotherapy is safe and more effective than just receiving the infusional chemotherapy alone.


Eligibility Criteria:
Inclusion:

* Patients over 18 years of age, of any race or sex, who have histologic and radiologic evidence of intrahepatic cholangiocarcinoma, who have been deemed unresectable by an experienced hepatic surgeon, and who are able to give informed consent, will be eligible
* Patients with at least one measurable liver tumor, with size \> 1cm (modified RECIST criteria)
* Patients with liver-dominant disease defined as ≥80% tumor burden confined to the liver
* Non-pregnant with an acceptable contraception in premenopausal women.
* Hematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 75 x109/L, INR ≤1.3 (patients on therapeutic anticoagulants are not eligible if they can not stop there anti-coagulation prior to DEBIRI and meet INR criteria)
* Adequate liver function as measured by: Total bilirubin ≤ 2.0 mg/dl,
* Adequate renal function (creatinine ≤ 2.3 mg/dl)
* Women of child bearing potential and fertile men are required to use effective contraception (negative serum βHCG for women of child-bearing age)
* Signed, written informed consent
* Less than 70% of liver parenchymal tumor replacement

Exclusion:

* Patient eligible for curative treatment (i.e. resection or tumor ablation).
* Active bacterial, viral or fungal infection within 72 hours of study entry
* Women who are pregnant or breast feeding
* ECOG Performance Status score of \>3
* Life expectancy of \< 3 months
* Allergy to contrast media that cannot be managed with standard care (e.g. steroids), making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated
* Presence of another malignancy with the exception of cervical carcinoma in situ and stage I basal or squamous cell carcinoma of the skin.
* Any contraindication for hepatic embolization procedures:
* Large shunt as determined by the investigator (pretesting with TcMMA not required)
* Severe atheromatosis vascular disease that precludes arterial cannulization
* Hepatofugal blood flow
* Main portal vein occlusion (e.g. thrombus or tumor)
* Other significant medical or surgical condition, or any medication or treatment, that would place the patient at undue risk and that would preclude the safe use of chemoembolization or would interfere with study participation
* Patients with prior contraindications for the use of irinotecan, gemcitabine, or cisplatin
* Patients who have received prior systemic therapy with either irinotecan, gemcitabine, or cisplatin
Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing

Prospective, follow-up registry of heart failure patients with or without sleep-disordered breathing (SDB). To test the hypothesis that treatment of nocturnal central sleep apnea with Cheyne-Stokes respiration by adaptive servoventilation (ASV) improves symptoms, cardiac performance and event-free survival.

The study is intended to investigate therapeutic effects of adaptive servoventilation in patients with sleep-disordered breathing and chronic heart failure. These effects include short-/long-term effects on

* symptoms and quality of life
* physical and cardiac performance (6min walking test, cardiopulmonary exercise testing)
* echocardiographic parameters
* arrhythmias
* NT-proBNP
* Respiratory stability (blood gases, rebreathing test, VE/VCO2-slope in cardiopulmonary exercise testing)
* Compliance with ASV therapy
* Event free survival (death, heart transplantation, assist device implantation)

All of these data are also obtained in patients who basically meet the inclusion criteria but in whom sleep-disordered breathing was excluded by means of cardiorespiratory polygraphy or polysomnography and in patients with sleep-disordered breathing who do not undergo adaptive servoventilation for various reasons.

Eligibility Criteria:
Inclusion Criteria:

* Stable heart failure NYHA ≥ II
* EF ≤ 45%
* without sleep-disordered breathing (apnea-hypopnea-index \<5/h) and those with moderate to severe central sleep apnea (apnea-hypopnea index ≥ 15/h) with or without adaptive servoventilation therapy

Exclusion Criteria:

* Cardiac resynchronization or pacemaker implantation within the last 6 months
* Significant COPD with an forced expiratory one-second capacity relative to vital capacity (FEV1/VC)\< 70% (GOLD III)
* Respiratory insufficiency requiring long-term oxygen therapy
* Daytime hypercapnia at rest (pCO2 \> 45 mmHg)
* Current ventilation therapy
* Cardiac surgery, PCI, myocardial infarction, unstable angina, TIA or stroke within 12 weeks prior to randomization
* Acute myocarditis within 6 months prior to randomization
* Pregnancy
A Dose Finding Study To Evaluate Safety, Drug Interaction, Tumor Markers Of Axitinib In Combination With MK-3475 In Adult Patients With Previously Untreated Advanced Renal Cell Cancer

Despite substantial improvements of patients outcome in advanced RCC, durable and complete response is uncommon. The majority of patients eventually develop resistance and exhibit disease progression. Combining a PD-1 inhibitor, which has shown single-agent efficacy with axitinib may provide additional clinical benefit compared to axitinib alone.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype with primary tumor resected
* At least one measureable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
* Eastern Cooperative Oncology Group performance status 0 or 1
* Controlled hypertension

Exclusion Criteria:

* Prior treatment with systemic therapy for advanced RCC
* Prior adjuvant or neoadjuvant therapy if disease progression or relapse has occurred during or within 12 months after the last dose of treatment
* Prior treatment with any agent specifically targeting T-cell co-stimulation or checkpoint pathways
* Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis
* Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of randomization except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low grade prostate cancer with no plans for treatment intervention
* In past 12 months: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack
* In past 6 months: deep vein thrombosis or pulmonary embolism
Multigen Plus H Study and AMF TT Cones

The aim of this study is to assess the clinical, patient-reported, and radiographic outcomes of a revision Total Knee Arthroplasty with Multigen Plus H and AMF TT Cones.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age ≥ 18 years old
* Given written informed consent approved by the reference Ethics Committee (EC)
* Subjects in whom a decision has already been made to perform a Total Knee Arthroplasty with the Multigen Plus H system as per Indication For Use. The decision to implant a Multigen Plus H system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to enrol the subject. This decision should be made in accordance with routine clinical practice at the study site concerned.
* Subject is able to comply with the protocol

Exclusion Criteria:

* Age \&amp;lt; 18 years old
* Subjects with any Multigen Plus system contraindication for use, or any AMF TT cones contraindication for use when used in combination with the Multigen Plus H, as reported in the current Instruction For Use.
* Any clinically significant pathology based on the medical history or any medical intervention that the Investigator feels may affect the study evaluation
* Female subjects who are pregnant, nursing, or planning a pregnancy
* Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS \&lt; 70 points.
Adapting a Model for Veterans on a Psychiatric Inpatient Unit

This randomized controlled study tests an adapted critical time intervention model for veterans discharged from a psychiatric inpatient unit. It is hypothesized that veterans on the inpatient unit who are assigned to such a community-based team will have shorter lengths of inpatient stay and better mental health. There have been few developments of community-based models of care in the post-deinstitutionalization era of short inpatient stays and the results of the study may inform how inpatient stays can be further reduced.


Eligibility Criteria:
Inclusion Criteria:

1. Admitted to the psychiatric inpatient unit for at least 4 days
2. Willing to participate in community-based treatment

Exclusion Criteria:

1. Actively suicidal or homicidal
2. Dementia
3. Drug or alcohol detoxification
4. Physician emergency certificate
Control of Epistaxis With Surgiflo

This is a blind trial to test if Surgiflo is effective in posterior epistaxis. After the investigators see than anterior tamponade is not effective stopping epistaxis, the investigators try using Surgiflo and if it does not work the investigators continue with a nasal catheter. This is the usual way to stop nasal bleeding, but is painful and has serious after-effects in the nose. Surgiflo is a hemostatic matrix that can be put into the nose, painlessly and easily. So the investigators think it can be useful controlling nasal bleeding, so the investigators could avoid to put nasal catheters in these patients.

Epistaxis is one of the most frequent diseases in Otolaryngology emergencies. Most of them are anterior and stop with an anterior packing. Some of them does not stop with this, therefore the investigators have to put into the nose a catheter balloon. This is very painful and has many after-effects in the nose.

Surgiflo is a haemostatic matrix used for bleeding.

The investigators have design a trial to know if some people can benefit from Surgiflo instead to put a nasal catheter.

This a randomized trial with two arms. In one arm the investigators will put surgiflo and not in the other.The patient will be admitted to the hospital. The investigators will see the difference in the hospital staying and in the effects in the nose, including discomfort or pain. The investigators will report age, gender, other diseases or treatments of the patients,type and length of bleeding, transfusions needed, arterial tension, coagulation. To do that the investigators will make hematological tests for haemoglobin and coagulation. To know the discomfort of the device the investigators will give the patient an analog visual scale in the moment the investigators will put the device, the day after and in any of the next visits. The patient can go home again after 16h without bleeding and the investigators will see the patient again in the office after 15 days, 1, 3 and 6 months.

All the patients will receive the same analgesic protocol so the investigators can compare the discomfort.

The investigators have make statistic analysis, and they will need 24 patients for this trial. The investigators will need 2 years, approximately, to recruit them.

Eligibility Criteria:
Inclusion Criteria:

* Patients with epistaxis in emergency room.
* Epistaxis does not stop with anterior nasal packing.

Exclusion Criteria:

* Pregnancy
* Allergy or intolerance to any component of Surgiflo.
* Septal perforation.
* Nasal surgery within 3 months previous to epistaxis.
* Patients admitted to hospital for other reasons.
Determination of Nerve Growth Factor (NGF) Expression in Pediatric Patients With Severe Burns: a Pilot Study

The goal of this observational study is to determine the blood values of NGF in severely burned patients, to describe any changes over time and finally to correlate the expression of NGF to the severity of the burn.

The main question it aims to answer is:

- describe NGF values in severely burned pediatric patients and to evaluate their correlation with the severity of the burn and the extent of the burned skin surface by measuring the circulating levels of NGF in pediatric patients.

Participants will undergo blood sampling on days 2,7,14 and 30 after the traumatic event for the clinical follow-up envisaged by the internal protocol.

Severe pediatric burns, characterized by an extension greater than 10% of the total body surface or by the involvement of particular districts such as the hands, face, airways or genitals, are characterized by multisystem involvement, which often requires intensive care support.

The epidermis begins to develop from the superficial ectoderm at the end of the fourth week of gestation when the neural tube separates from the overlying ectoderm. Consequently, the ectoderm gives rise to both the nervous system and the epithelium.

In particular, the NERVE GROWTH FACTOR (NGF) is a neurotrophic factor that plays a fundamental protective role in the development and survival of neurons.

In fetal skin, NGF is synthesized in both the epithelium and mesenchyme, but the highest amounts of NGF messenger ribonucleic acid are found in the epithelium. There are currently no studies investigating the expression of NGF in severe burns.

The common embryonic origin of the skin and the neurological system may hold the key to new research opportunities to understand the regenerative response and in particular the role of growth factors such as NGF in the skin repair mechanism in severe burns .

The hypothesis of the study is based on the possibility that skin burns may be related to an increased expression of circulating NGF in the blood. However, there are no data in literature on this issue and the behavior of NGF in patients affected by burns is not known, either in adult or pediatric patients.

Aim To describe NGF values in severely burned pediatric patients and to evaluate their correlation with the severity of the burn and the extent of the burned skin surface by measuring the circulating levels of NGF.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from severe burns

Exclusion Criteria:

* Major congenital malformations
* Antibiotic treatment 48 hours prior to admission
* Norepinephrine infusion \> 0.5 mcg/k/min
* Lack of informed consent from parents or legal guardians
Implementation of COVID-19 Testing Strategies in Community Health Centers

This project is part of a competitive revision to accelerate COVID-19 testing in underserved populations. The overall aim is to implement strategies to expand COVID testing in hotspot communities in MA, through 6 community health center (CHC)-community partnerships. A base strategy will be implemented at all sites. A tailored strategy unique to local populations will be added and tested in a stepped wedge design.


Eligibility Criteria:
Inclusion Criteria:

* Participants are patients at the intervention or control CHCs or members of the local community. The participating sites constitute one group; a set of matched control CHCs that will conduct testing as usual constitute the second group.

Exclusion Criteria:

* None
Thoracic Paravertebral Block With Methylene Blue Visual Confirmation for Postoperative Pain After VATS Lobectomy

The goal of this study is to compare the efficacy in controlling postoperative pain of paravertebral block (PVB) with methylene blue visual confirmation and thoracic epidural anesthesia (TEA). This is a single center, parallel-group, prospective study. Patients will be randomly assigned in a 1:1 ratio to receive either PVB or TEA. Primary end-point is pain relief measured with Postoperative Numeric Rating Scale. The secondary end-points are time to perform TEA and PVB, total opioid consumption, postoperative outcomes.

The management of postoperative pain in patients undergoing thoracoscopic lobectomy is a fundamental part of the process of recovery. Uncontrolled thoracic pain in the early postoperative period may interfere with the mobilization of the patients, leading to increased morbidity and reduction in the quality of life.

Thoracic paravertebral block (PVB) is an effective strategy for controlling postoperative pain after video-assisted thoracoscopic (VATS) lobectomy, but it may be subjected to a high rate of failure due to incorrect identification of the site of local anesthetic injection.

Thoracic epidural anesthesia (TEA) is considered a reliable technique for regional thoracic anesthesia, however potential side effects may limit its use.

Herein the investigators reported a new technique using methylene blue as a visual confirmation of the correct anesthetic diffusion during PVB. Then, the investigators will compare the efficacy of methylene blue PVB with TEA for the management of postoperative pain in patients undergoing VATS lobectomy.

This is a single center, parallel-group, prospective study. Participants will be randomly assigned in a 1:1 ratio to receive either PVB with methylene blue or TEA.

All participants will receive postoperatively intravenous acetaminophen as additional analgesics and intravenous tramadol as rescue analgesic. Primary end-point is pain relief measured with Postoperative Numeric Rating Scale at at 1, 12, 24, 48 hours postoperatively. The secondary end-points are: (i) time to perform TEA and PVB, (ii) total opioid consumption, (iii) postoperative outcomes (including complications, chest drainage duration and length of hospital stay).

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 - 85 years old
* scheduled to undergo thoracoscopic lobectomy for lung cancer
* standardized three-port anterior thoracoscopic approach

Exclusion Criteria:

* Allergy to any of the drugs used in the study
* Previous thoracic surgical procedures or lung resection
* Psychiatric disorders
* ASA (American Society of Anesthesiologists) Class \> III
* Conversion to thoracotomy
* Lack of written informed consent
* Participation to other studies
* Contraindications to epidural analgesia or paravertebral block
Study on the Effect of 3T Pu'er Tea in Regulating Glucose and Lipid Metabolism

To study the effect of Pu'er tea in overweight / obese patients with blood glucose or abnormal lipid metabolism. Compared with the effect of two Pu'er tea with different tea fuscin content in improving glucose and lipid metabolism, to investigate the mechanisms of bile acid metabolism and intestinal flora regulation.

In a prospective randomized controlled clinical study, 90 patients were divided into study group (3T Pu'er tea group, 45 patients) and control group ( traditional Pu'er tea group,45 patients). Before and after the treatment(0day, 12 weeks, 52 weeks) patients' markers of glucose and lipid metabolism were examined and compared.


Eligibility Criteria:
Inclusion Criteria:

The A、B should be simultaneously met, or combined with the C、D、E.

1. 18-65 years, priority for patients over 30 years;
2. Overweight / obese patients: BMI ≥24 kg/m2.
3. Or combined with nonalcoholic fatty liver disease: determined by the hospital MRI nuclear magnetic quantification;
4. Or combined with dyslipidemia: blood total cholesterol TC≥6.4mmol/L or blood total triglyceride TG≥2.0mmol/L or blood low-density lipoprotein LDL-C≥3.1mmol/L;
5. Or with abnormal blood glucose:

   * Impaired fasting glucose, IFG: fasting blood glucose was 6.1\~\<7.0mmol/L,and 2 hours after 75g oral blood glucose tolerance test(OGTT) \<7.8mmol / L.
   * Impaired glucose tolerance, IGT: the fasting blood glucose was \<6.1mmol/L and 2 hours after 75gOGTT was 7.8\~ \<11.1 mmol / L;
   * IFG with IGT: patients with both IFG and IGT;
   * Patients with type 2 diabetes: random blood glucose 11.1mmol/L or fasting glucose of 7.0 mmol/L or 2 hours after OGTT.

Exclusion Criteria:

1. Type 2 diabetes and insulin injections or oral hypoglycemic drugs and other special types of diabetes.
2. For women during pregnancy or lactation or with allergies;
3. Patients treated with any hypoglycemic drugs and insulin injections; regular or planned patients taking drugs that may affect glucose and lipid metabolism (as judged by clinicians, such as diet pills, lipid-lowering drugs) and liver protection drugs (as judged by clinicians);
4. Patients with severe cardiovascular diseases, cerebrovascular diseases, liver, kidney, and hematopoietic diseases;
5. Combined with other infectious diseases, such as hepatitis A, hepatitis B, hepatitis C, and acquired immunodeficiency syndrome;
6. Take probiotics, prebiotics, antioxidants and fish oil nutrient supplements within 3 months;
7. Current smokers and regular drinking (excluding social drinkers only);
8. Yogurt intake within 1 week before the first visit and antibiotics within 3 months;
9. Drink strong tea regularly;
10. Participate in other clinical trials within 3 months;
11. Unable not cooperate with the investigator for other reasons.
12. Unfit for the researcherr.
Fixed Dose Heparin Study

FIDO was a multicentred randomized, open-label trial that compared fixed-dose UFH with fixed-dose LMWH for initial treatment of VTE. Patients were followed for 3 months during which they received warfarin (target INR 2.0-3.0).

The general objective was to simplify and reduce the cost of treatment of acute venous thromboembolism (VTE).Specific objectives were to compare the efficacy, safety and cost effectiveness of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) when each is administered subcutaneously (sc), twice daily, in weight -adjusted, fixed doses; and to determine if the anticoagulant response (anti-Factor Xa heparin levels, APTT results) influence efficacy and safety of UFH and LMWH, independently of dose.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of acute venous thromboembolism (VTE,DVT and /or PE)

Exclusion Criteria:

* Contraindication to subcutaneous (sc) route of administration (eg:shock (evidence of poor peripheral perfusion), major surgery within 48 hours)
* Active Bleeding process
* Comorbid condition limiting expected survival to less than 3 months
* Current treatment with therapeutic dose of UFH, LMWH, danaparoid sodium, or a direct thrombin inhibitor for more than 48 hours
* Currently on long term warfarin or heparin therapy
* Allergy to heparin or history of heparin induced thrombocytopenia
* Currently pregnant
* Contraindication to contrast media (eg: allergy or creatinine \>200 umol/L).
* Currently enrolled or will be enrolled in a competing study
* Geographically inaccessible for follow-up assessment