cyrilzakka/clinical-trials huggingface dataset:
Strategies for Inflammation and Cardiovascular Disease (CVD) Prevention

The long-term goal of the proposed research is to identify and develop effective interventions to decrease persistent, low-level inflammation and risk of CVD. Stress is a substantial contributor to inflammation, and interactions among stress, inflammation, body mass index, and health behaviors have been measured. Mindfulness-based stress reduction (MBSR) is effective for stress reduction, has been shown to be effective for inflammation reduction in individuals with disease, and is a sustainable practice for individuals across the health spectrum. Diet strategies are an effective means of reducing inflammation for some individuals, but may not be successful for many people, as evidenced by the steady rise in obesity rates. The specific aims of this study are to 1) test the effectiveness of MBSR compared to an established intervention of a nutrition enhancement (NE) intervention for the reduction of inflammation, and 2) test the effectiveness of MBSR compared to a non-intervention control conditions (CON) for the reduction of inflammation. Men and women 25-45 years of age will be randomly assigned to participate in MBSR (n=60) or DIET (n=60) or CON (n=60) interventions for 16 weeks. Serum CRP concentrations, additional inflammatory cytokines (tumor necrosis factor-a, interleukin-6), cortisol diurnal profiles, anthropometrics, dietary intake, and all components of the metabolic syndrome will be measured pre- and post-intervention to elucidate underlying mechanisms and to determine whether health benefits beyond inflammation reduction occur.


Eligibility Criteria:
Inclusion Criteria:

* Elevated waist circumference or BMI

Exclusion Criteria:

* Participation in calorie restricted diet in previous 30 d
* Participation in stress reduction program in previous 30 d
* Take blood pressure, lipid lowering or anti-inflammatory medications
* Hypertension
* Diabetes
* Heart disease
Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen)

Rationale: Extracts of the plant Salvia miltiorrhiza (Danshen) have been used as traditional Chinese medicine in the treatment of cardiovascular diseases, such as angina pectoris and myocardial infarction. Several preclinical studies point towards promising effects of Danshen on risk factors of atherosclerotic cardiovascular diseases, such as hyperlipidemia and hypertension.

Objective: Our primary objective is to determine the effect of Salvia miltiorrhiza extract (Danshen) on hyperlipidemia. Secondary objective is to investigate the effect of Danshen on hypertension. Further objectives are to determine its effect on endothelial function, oxidative stress, inflammation, hemostasis and hemorheology, and on insulin sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Age: 40-70
* Women:

  * postmenopausal, or
  * use of contraceptive pill
* Hyperlipidemia:

  * elevated level of triglycerides: \> 1.7 mmol/L, or
  * elevated level of LDL-cholesterol: \> 3.5 mmol/L
* Hypertension:

  * systolic pressure \> 140 mm Hg, or
  * diastolic pressure \> 90 mm Hg
* Signed informed consent

Exclusion Criteria:

* Alcohol or drug abuse
* History of cardiovascular disease (myocard infarct, angina pectoris, CVA)
* Diabetes mellitus, when treated with insulin
* Pregnancy
* Hyperlipidemia which needs conventional treatment

  * elevated level of triglycerides: \> 8 mmol/L
  * elevated level of LDL-cholesterol: \> 5 mmol/L
* Hypertension which needs conventional treatment:

  * systolic pressure \> 180 mm Hg
  * diastolic pressure \> 110 mm Hg
* Clinically significant liver disease (3 times the upper normal limit of ALAT,ASAT)
* Clinically significant anemia (male Hb \< 6,9 mmol/L, female \< 6,25 mmol/L)
* Renal disease defined as MDRD \< 60 ml/min/1.73m2
* Participation to any drug-investigation during the previous 90 days
* Use of any herbal product during the previous 30 days
* Concomitant (chronic) use of:

Medicinal products:

* ACE-inhibitors, including a.o. captopril, enalapril, ramipril
* AT1-antagonists, including a.o. losartan, valsartan, irbesartan
* Statins, including a.o. simvastatin, rosuvastatin
* Anticoagulant drugs, including a.o. aspirin
* Calciumantagonists (including a.o. amlodipine, nifedipine, verapamil)
* Use of more than 1 antihypertensive drug
* High-dose antihypertensive medication (above defined daily dose)
* Drugs which are exclusively metabolised by CYP3A4 (Flockhart DA; P450 drug interaction table, including a.o. erythromycin, midazolam, cyclosporine, HIV antivirals)

Food products:

* (Antioxidant) vitamin supplements
* Other herbs, including a.o. St John's wort
* Grapefruit juice
Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of GI-aGVHD

This study aims to determine whether the fecal microbiota transplant (FMT) capsule improves the response rate of GI-aGVHD in patients with glucocorticoid-refractory acute graft vs. host disease after allogeneic stem cell transplantation


Eligibility Criteria:
Inclusion Criteria:

* 1. GVHD within 100 days after allogeneic hematopoietic stem cell transplantation (allo HSCT);

  2. Age 18 - 65 years old, regardless of gender;

  3. Patients with grade 3 or 4 gastrointestinal involvement (aGVHD) according to the International Alliance (Magic) classification standard;

  4. Patients with glucocorticoid resistant GI aGVHD are diagnosed. According to the expert consensus of Chinese allogeneic hematopoietic stem cell transplantation for the treatment of hematological diseases (III) - acute graft-versus-host disease (2020 Edition), the definition of glucocorticoid resistant acute GVHD is Thomas' hematopoietic cell transplantation: stem cell transplantation (5th Edition) Glucocorticoid resistance was defined as PD at 3 days, NR at 7 days or Cr not reached at 14 days after first-line treatment.

  5. ECoG 3 points or less;

  6. Stop prophylactic antibiotics at least 12 hours before FMT treatment;

  7. Be able and willing to sign informed consent;

  8. Patients who are capable of swallowing capsules and can complete the study;

Exclusion Criteria:

* 1. There are active but uncontrolled infections, except GVHD complicated with infectious diarrhea;

  2. Gastrointestinal perforation, active gastrointestinal bleeding, small intestinal obstruction, toxic megacolon or other serious gastrointestinal diseases not caused by GVHD;

  3. Have a history of severe allergic reaction; Or known to be allergic to any ingredient of intestinal bacteria capsule xbi-302;

  4. Any serious disease that can increase the risk of patients participating in the study;

  5. Female subjects with positive pregnancy test and lactation, or female subjects of childbearing age who refuse to take contraceptive measures during the study;

  6. According to the judgment of the researcher, the patients with high dynamic diarrhea can not stay in the intestine for enough time to dissolve the capsule.

  7. HIV, HBV, HCV and syphilis are positive;

  8. After colectomy;

  9. Participate in other intervention clinical studies within 4 weeks before the screening period;

  10. The expected survival time is less than 12 weeks;

  11. The basic body function test is inferior to the following standards: total neutrophils (neu) \< 0.5 (x109 / L), platelet count (PLT) \< 30 (x109 / L), serum creatinine (CR) \> 1.5 times the maximum normal value (ULN), albumin (ALB) \< 25g / L;

  12. There is any situation that the researcher thinks is not suitable for inclusion (any history of medical history, treatment history or abnormal test data that may confuse the results of this study, interfere with the subject's whole participation in the study, or harm the interests of the subject).
The Use of Tocilizumab in the Management of Patients Who Have Severe COVID-19 With Suspected Pulmonary Hyperinflammation

Title: The use of Tocilizumab in the management of patients who have severe COVID-19 with suspected pulmonary hyperinflammation.

This is a study designed to assess the therapeutic value of intravenous tocilizumab administered as single 8mg/Kg dose in patients affected by SARS-CoV2 infection with a pulmonary manifestation causing hypoxia. Aim of the study is to test the hypothesis that anti-IL6 treatment can be effective in reducing the virus-induced cytokine storm, blocking deterioration of lung function or even promoting a rapid improvement of clinical conditions, preventing tracheal intubation and/or death.

This drug will be administered to those patients entering the ICU with severe acute respiratory failure COVID-19 disease. The endpoints are death and duration of hospitalization. The patients will be assessed with surrogate markers determining the level of the cytokine storm.

Study design This is a multicenter, two arms, 2:1 (treatment: control) open-label randomized control study with a drug approved for another indication in Israel. All the patients enrolled will be treated with tocilizumab or not. One-month mortality rate is the primary endpoint. One arm will be the study drug anti-IL6R (Tocilizumab (Actmera)) 8 mg/kg given IV during one hour once. The placebo will be a 100 ml saline IV infusion administered along one hour.

Eligibility Criteria:
Inclusion Criteria:

1. Any gender
2. Age 18 and older
3. Informed consent for participation in the study
4. Virological diagnosis of Sars-CoV2 infection (PCR)
5. Acute respiratory failure
6. Radiographic pneumonia, defined as any/ changing new lung infiltrate
7. Patient breathing spontaneously, required more than 50% oxygen and MEWS score \> 7.
8. If intubated, intubated less than 24 hours with PaO2/Fio2 ratio ≤ 200 and PEEP ≥ 5 cm H2O.

Exclusion Criteria:

1. Known hypersensitivity to tocilizumab or its excipients
2. Patient with a life expectancy of less than 6 months.
3. Known active infections or other clinical condition that contra-indicate tocilizumab and cannot be treated or solved according to the judgement of the clinician.
4. Neutrophils \<500 / mmc
5. Platelets \<40.000 / mmc
Blood and Urine Sample Collection From Healthy Volunteers

The aim of the study is to obtain blood and urine samples from healthy volunteers to serve as a healthy control group for cross-cohort comparisons.

The aim of the study is to obtain peripheral venous blood samples and a urine sample from 100 healthy volunteers on one day at three different times of the day, to serve as a healthy control group for cross-cohort comparisons.

With the help of the urine and blood samples obtained in this context, a cohort of a healthy collective is to be established for further research purposes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged 40-70 years.
* Caucasian
* Non-smokers or ex-smokers
* Body Mass Index (BMI): ≥18.5 and ≤32 kg/m2
* Presence of a negative SARS-CoV-2 PCR test.

Exclusion Criteria:

* Complaints that may indicate the presence of an infection, including Covid-19.
* Pathological alcohol consumption.
* Positive alcohol breath test at the preliminary examination.
* Alcohol consumption within the last 24 hours before the start of sampling.
* History of drug dependence.
* Positive urine drug test during the preliminary examination.
* Clinically significant acute or chronic disease. In particular, chronic inflammation, rheumatological and other autoimmune diseases, diabetes and other metabolic diseases.
* Indications in the medical history or during the medical examination that may jeopardize the safety of the study participant by participating in the study.
* History of relevant clinically significant cardiovascular disorders or clinically relevant hyper- or hypotension or clinically relevant brady- or tachycardia at screening as assessed by an investigator.
* Heart rate \<45/min after 5 minutes in a quiet sitting position.
* Heart rate \>100/min after 5 minutes in a quiet sitting position.
* Systolic blood pressure of \> 170 mmHg or \< 90 mmHg.
* Diastolic blood pressure of \> 95 mmHg and/or \< 60 mmHg.
* Regular use of prescription medication within 3 months prior to inclusion in the research project.
* Use of non-prescription medications within 3 days prior to inclusion in the research project.
* Presence of clinically significant food intolerance and/or food allergy as assessed by the investigator.
* Medically relevant previous operations.
* Condition following radio- or chemotherapy.
* History of oncological diseases.
* Blood and/or plasma donation within the last 30 days prior to sample collection.
* Pregnant or nursing female.
* Employees of study site.
Effects of Different Recovery Methods on Lactic Acid Removal, Flexibility, Strength, and Endurance

The aim of this study is to compare these three different recovery methods following a single bout high-intensity interval exercise program with each other in terms of blood lactate clearance, muscle flexibility, muscle strength and endurance.

It is very important to choose the most effective recovery method for the athletes in training for their next training/competition. The recovery period is very significant in terms of removal of blood lactate and body dynamics as soon as they return to their original state and achieve high performance. Neither neuromuscular electrical stimulation, low-intensity aerobic exercise, self-massage with foam roller methods, which have been proven their effectiveness in the literature, have been compared with each other.

Eligibility Criteria:
Inclusion Criteria:

Young, healthy adults aged 20-25 years.

Exclusion Criteria:

* Clinical diagnosis of a cardiovascular disease.
* Clinical diagnosis of a metabolic disorder, orthopedic or neurological disease that would interfere with an exercise program,
* Clinical diagnosis of hemophili,
* Clinical diagnosis of thrombophlebitis or deep vein trombosis,
* Clinical diagnosis of peripheral arterial disease,
* Clinical diagnosis of venous insufficiency,
* Clinical diagnosis of anemia,
* Pregnancy.
Head and Neck Paragangliomas: A 16-year Experience of a University Hospital in Turkey

The aim of the study is to examine the head and neck paraganglioma cases treated in Pamukkale University hospital between 2007-2023 and improve our understanding of these cases and contribute to the knowledge surrounding head and neck paragangliomas.

39 patients were selected and analyzed retrospectively. Demographic informations, complaints at the time of admission, radiological examinations, paraganglioma types, stages, postoperative complications, and relapsed cases were recorded.Preoperative staging plays a crucial role in surgical planning and predicting potential intraoperative complications. In such cases, combination therapy alongside surgery may improve treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Histopathological diagnosis of carotid paraganglioma
* Histopathological diagnosis of vagal paraganglioma
* Histopathological diagnosis of jugular paraganglioma
* Histopathological diagnosis of tympanic paraganglioma

Exclusion Criteria:

-Inadequate information in files
Mitro-annular Disjunction in Cardiac Magnetic Resonance

Mitral annular disjunction (MAD) is an abnormal atrial displacement of the mitral valve leaflet hinge point. MAD is gaining clinical importance for several studies reporting its association to mitral valve prolapse (MVP), complex ventricular arrhythmias and sudden cardiac death.

On the other hand, other studies found MAD as an extremely diffuse anatomical variant of mitral valve annulus without any pathological implication.

Cardiac Magnetic Resonance is the non-invasive gold standard for myocardial characterization, with the possibility of accurate anatomical and functional evaluation associated to the evaluation of focal and interstitial fibrosis, resulting useful in the identification of arrhythmic substrate and for patients risk stratification. Additionally, Cardiac Magnetic Resonance (CMR) was found to be superior to echocardiography not only in term of tissue characterization, but also in the identification of small MAD.

Therefore, in relation to the scarcity of data about MAD prevalence and pathological potential, we set a large multicenter retrospective study aimed to evaluate prevalence of MAD in patients submitted to CMR independently by the clinical suspicion, and to evaluate the association with prolapse and arrhythmias.

Multicenter retrospective study. All cardiac MRI study obtained during the first semester of 2019 will be screened in order to identify the presence and severity of MAD, it association to other myocardial condition such as bileaflet mitral valve prolapse, miltral regurgitation, curling, and focal and interstitial fibrosis at LGE and ECV evaluation.

Finally, the association between MAD and arrhythmias will be investigated.

Eligibility Criteria:
Inclusion Criteria:

• Consecutive adult patients (age ≥18 years-old), submitted to Cardiac Magnetic Resonance independently by the clinical suspicions in the first 6 month of 2019 (from January to June 2019) that have signed an Informed Consent authorizing data collection for future retrospective clinical research protocols

Exclusion Criteria:

• Pediatric patients (age \<18 years-old), cardiac devices (implantable devices), previous mitral valve surgery, lack of LGE images, lack of clinical information about presence of arrhythmias. The timeline was selected to avoid the impact of COVID-19 pandemic on CMR availability, scheduling, and findings.
Sodic Heparin Effectiveness of the Treatment of Burns

Burns are injuries caused by agents thermal, chemical, electrical or radioactive who act in the tissue lining of the human body and may partially or totally destroy the skin and its annexes, to the deeper layers, as subcutaneous tissue, muscles, tendons and bones .

Studies show that topical heparin has, in addition to the already known anticoagulant activity, anti-inflammatory properties, analgesic, and neoangiogenic, stimulating blood flow and increasing the repair of the fabric as well as the restoration of collagen and reepiteliztion. Moreover, the use of heparin reduces the need for painful medical procedures, as debridations, surgeries and transplants The intention of this work is to verify the effectiveness and safety of sodium heparin in the treatment of burns of the skin.

Patients with burns that come to the emergency room will be informed about the

Inclusion Criteria

* Patients aged above 12 years who have suffered thermal burns of 2nd degree burns or mixed 2 and 3 degrees in up to 10% of body surface and indication of outpatient treatment.

Exclusion Criteria

* Area burned more than 10% of body surface
* the presence of the 3 rd degree burns
* burns in the face or genitals
* burns in poly-traumatized
* respiratory injury
* disorders of coagulation
* thrombocytopenia
* erosive gastro cases
* clinically relevant bleeding
* hypersensitivity to anticoagulants
* liver disease
* nephropathy
* diabetes
* 35
* serious allergy
* descontrole emotional
* pregnancy
* anemia

Eligibility Criteria:
Inclusion Criteria:

* Patients aged above 12 years who have suffered thermal burns of 2nd degree burns or mixed 2 and 3 degrees in up to 10% of body surface and indication of outpatient treatment.

Exclusion Criteria:

* Area burned more than 10% of body surface
* the presence of the 3 rd degree burns
* burns in the face or genitals
* burns in poly-traumatized
* respiratory injury
* disorders of coagulation
* thrombocytopenia
* erosive gastro cases
* clinically relevant bleeding
* hypersensitivity to anticoagulants
* liver disease
* nephropathy
* diabetes
* 35
* serious allergy
* descontrole emotional
* pregnancy
* anemia
Impact of Postanesthesia Care Unit Delirium on Postoperative Quality of Recovery

Postanesthesia care unit (PACU) delirium is subtype of postoperative delirium that occurs early after anesthesia and surgery during the recovery period. The consequences of PACU delirium have not been investigated thoroughly. So far it is unknown, whether patients with PACU delirium experience impaired postoperative quality of recovery.

The aim of this observational study is to assess the impact of PACU delirium on quality of recovery 24 hours after general anesthesia for elective non-cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* elective non-cardiac surgery
* general anesthesia
* fluency in German

Exclusion Criteria:

* expected postoperative ICU stay
Transcranial Direct Current Stimulation for Migraine Attack

This study is conducted to investigate the therapeutic efficacy and safety of transcranial direct current stimulation (tDCS) over the primary motor cortex of patients with acute migraine attack.


Eligibility Criteria:
Inclusion Criteria:

* Aged 17-70 years
* Migraine

  * With or without aura
  * The first attack of migraine was earlier than 50 years of age
  * One to 8 moderate to severe migraine attacks per month in the 2 months preceding the screening
* Willing and able to give written informed consent
* Able to read, comprehend and complete the diary form

Exclusion Criteria:

* Not able to distinguish between migraine and non-migraine headache
* Combined headache, including the tension type headache and medication overuse headache
* Pregnant, actively trying to become pregnant or breast-feeding women
* Uncontrolled and significant medical illness
* Vertebrobasilar or hemiplegic migraine according to the International Headache Society diagnostic criteria
* Having intracranial metal implants or a cardiac pacemaker
* A history of epilepsy or other organic brain disorders
* A history of psychological diseases
* Having changed medications for migraine within 1 month before giving us informed consent
* Drug abuser or alcoholics
Protocol Based Selective Imaging Versus Routine Computed Tomography or Ultrasound in Suspected Appendicitis

The goal of this clinical trial is to compare protocol based selective imaging to routine imaging in adult patients with suspected appendicitis. The main question\[s\] it aims to answer are:

* Does protocol based selective imaging using clinical scoring affect clinical outcome?
* Does protocol based selective observation combined with score based selective imaging affect clinical outcome?

Participants will be randomized into three groups:

* Selective imaging based on Adult Appendicitis Score
* Selective observation based on Appendicitis Severity Score combined with selective imaging based on Adult Appendicitis Score
* Routine imaging using ultrasound and/or computed tomography

Researchers will compare selective imaging groups separately with routine imaging to see if number of negative appendectomies or number of complicated appendicitis is not significantly increased.


Eligibility Criteria:
Inclusion Criteria:

- Suspicion of appendicitis

Exclusion Criteria:

* Time from symptom onset over 72 hours
* Age \<18 years
* Pregnancy, ruled out by serum or urine HCG measurement in 18- to 49-year-old women
* CT-scan or ultrasound already done within the last 3 days (72 hours)
* Clinical suspicion of other disease or other reason to perform imaging study
* Recruited earlier to the same trial
Cera™ VSD Occluder Post Market Clinical Follow-up

The objective of this post-market registry is to assess the safety and performance of the Lifetech Cera™ VSD occluder in a real-world and on-label fashion.

The study intends to collect data from patients who have implanted with the device before 2022. The study is expected to completed by the end of 2024.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of Ventricular Septal Defect (VSD) and implanted with the investigational device as per IFU instructions

Exclusion Criteria:

* Patients did not conduct any follow up visit after hospital discharge.