cyrilzakka/clinical-trials huggingface dataset:
Transforming Nanoparticle Dressing For Management of Chronic Venous Ulcers

The present randomized controlled study aims to evaluate the role of transforming nanoparticle dressing n management of chronic venous ulcers.

The present randomized controlled study was conducted at Helwan University Hospitals, Cairo, Egypt. The study protocol was approved by the local ethical committee and all patients gave informed consent before enrollment.

The study included 60 patients with CVU. Patients were diagnosed on the basis of clinical findings and vascular Doppler ultrasonography. Exclusion criteria were associated infection and associated ulcers of other etiologies. Patients randomization was achieved using computer generated numbers and sealed envelope technique. Randomization and patients' allocation to the study interventions was performed by an independent researcher who wasn't aware of the study interventions and outcome.

Upon recruitment, patients were subjected to careful history taking, thorough clinical examination, standard laboratory investigations and vascular ultrasound examination. The recorded parameters included demographic data (age, sex and body mass index), associated morbidities, duration and size of CVU and history of previous interventions.

After randomization, patients in the treatment group (n=30) had transforming nanoparticle dressing while the control group (n=30) received conventional compression dressing. Before applications of both dressings, the wound area was thoroughly cleaned. In the treatment group, the dressing powder was applied as a thin layer to the ulcer surface. Any excess powder surrounding the ulcer area was removed. In both groups, a secondary protective gauze dressing was applied. Patients were follow up at weekly intervals until complete healing occurs.

The primary end-point in the present study is the time to complete healing. The secondary end-point the rate of healing (percent of reduction in ulcer area).

Eligibility Criteria:
Inclusion Criteria:

* Chronic venous ulcers.

Exclusion Criteria:

- Associated infection and associated ulcers of other etiologies.
Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase

Chronic hepatitis B virus (HBV) infection remains a global public health burden around the world. Investigating the disease process of chronic hepatitis B (CHB) is essential to individual management in clinical practice. According to American Association for the Study of Liver Diseases (AASLD) 2018 Hepatitis B Guidance, CHB can be classified into four phases: immune-tolerant CHB, HBeAg-positive immune active CHB, inactive CHB and hepatitis B e antigen (HBeAg)-negative immune active CHB. Antiviral therapy is recommended in patients with HBeAg-positive or -negative immune active CHB patients to reduce the incidence of liver cirrhosis and hepatocellular carcinoma, while periodic monitoring is recommended for inactive carrier and immune-tolerant CHB patients. However, a substantial proportion of patients fall into an indeterminate phase whose serum HBV DNA and alanine aminotransferase levels do not fit well into these well-described phases. Most of CHB patients with indeterminate phase are HBeAg negative. However, the clinical outcomes of these patients remain unclear. Therefore, the purpose of this study is to investigate the clinical outcomes of HBeAg-negative chronic hepatitis B patients with indeterminate phase.


Eligibility Criteria:
Inclusion Criteria:

1. Hepatitis B surface antigen (HBsAg) positive over 6 months
2. Age ≥18 years
3. Treatment-naïve
4. HBeAg negative, anti-HBe positive
5. HBV DNA \>2000 IU/mL
6. Persistently normal alanine transaminase (ALT)
7. Liver inflammation \<G2 or A2 and liver fibrosis \<S2 or F2 before enrollment, or liver stiffness \>8 kilopascals (kPa)
8. No family history of liver cirrhosis or hepatocellular carcinoma

Exclusion Criteria:

1. Coinfection with hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus or human immunodeficiency virus;
2. Coexisting of hepatocellular carcinoma and other malignancy, or alpha-fetoprotein \>upper limit of normal at enrollment;
3. Presence of liver cirrhosis;
4. Alcohol abuse within the last year (ethanol: male \>40 g/d, female \>20 g/d; or heavy drinking within 2 weeks before enrollment: ethanol \>80 g/d), or history of drug abuse;
5. Participating in other clinical trials in the last 3 months;
6. Coexisting of autoimmune liver diseases;
7. Pregnant or planned pregnancy in a short term or lactation patients;
8. History of severe heart disease, mental disease;
9. Uncontrolled diabetes, hypertension, thyroid dysfunction, retinopathy, autoimmune diseases;
10. Neutrophil count \<2×10\^9/L and/or platelet count \<100×10\^9/L;
11. History of organ transplantation or preparing for organ transplantation;
12. Using immunosuppressive drugs;
13. Undergone organ transplantation or preparing for organ transplantation;
14. Receiving immunosuppressive agents;
15. Patients thought by the investigators not suitable to participate in this study.
Effects of a Zumba Dance Program for Postmenopausal Women With Metabolic Syndrome

The aim of this study is to examine the effects of a 12-week Zumba dance intervention on fitness, anthropometric and psychometric parameters and eating behavior.


Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women (Age 45-65)
* waist of \>94 cm or BMI \> 30kg/m2
* not physically active \>1x/week for 20 minutes
* written consent before the start of the study

Exclusion Criteria:

* involvement in other clinical studies
* unable to participate at the dance lessons
* medical contraindications for the intervention or increased risk for exercise participation
Safety and Efficacy of Fludarabine and Cyclophosphamide + Rituximab

Purpose of this study was to assess the safety profile and the anti-lymphoma activity of the FC+R combination.

The natural history of follicular lymphomas is characterized by a high initial response rate to chemotherapy followed invariably by relapse, with subsequent remissions of progressively shorter duration. The majority of patients eventually die of their disease. As yet, there is no gold standard for the treatment of newly diagnosed or relapsed advanced FL.Rituximab(R) has been shown to be a highly effective agent in the treatment of FL, either alone or in combination with chemotherapy. The ability of R to sensitize indolent lymphoma derived cell lines to cytotoxic chemotherapy agents has been demonstrated. Furthermore, fludarabine (F) may also sensitize cells to the effects of R. Cyclophosphamide (C) and F have shown in vivo synergistic activity. In view of the single agent activity and demonstrated synergy between C and F, and between F and R, we evaluated FC+R in previously treated patients with advanced FL. The primary aim of this study was to assess the safety profile and clinical activity of the FC+R combination. The secondary goal was to evaluate the ability of the treatment to convert bone marrow Bcl2 positivity such that patients achieved molecular remissions.

Eligibility Criteria:
Inclusion Criteria:

* histologically documented WHO grade 1-2 ,CD20+,follicular lymphoma
* relapsed Follicular lymphoma
* stage III or IV disease
* Stage II patients are eligible if they present with B symptoms or bulky disease
* to have a need for therapy in the opinion of treating clinician
* measurable disease
* expected survival of 6 months or more
* age 18 to 70 years
* to have undergone \< 3 lines of chemotherapy
* performance status of 0 to 2

Exclusion Criteria:

* known HIV infections
* Known Hepatitis B or C
* CNS lymphoma
* previous malignancies, or cardiac, renal, hepatic, or respiratory failure
* Pregnant or lactating women and patients of child bearing potential unless using birth control measures
Paravertebral Block Vs No Block in Open Pancreaticoduodenectomy

The purpose of this study is to compare intra and postoperative pain control between Paravertebral block vs no block in open pancreaticoduodenectomy. Length of stay, and complications will also be recorded. For this study the investigator plans to randomize to obtain objective data for clinical decisions and improve patient outcomes. Following surgery patients in both groups, data will be collected from the first 48 hours after surgery and at discharge.


Eligibility Criteria:
Inclusion Criteria:

* Patients willing and have signed consent.
* Nonpregnant adults undergoing open pancreaticoduodenectomy via standard upper midline incision without contraindications to para vertebral block (PVB)

Exclusion Criteria:

* Not able or unwilling to sign consent.
* Currently pregnant or lactating.
* Patients with chronic pain, requiring daily opiate use at time of surgery.
* Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.
A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease

Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of developing cardiac events.

The purpose of this clinical research study is to determine how well CARDIOLITE® rest and stress myocardial (heart) imaging can define the pediatric Kawasaki disease (KD) population into high and low risk categories of developing cardiac (heart) events (complications) from 1 year through 3 years after image completion. The safety of CARDIOLITE® rest and stress heart imaging will also be studied.

Eligibility Criteria:
Inclusion Criteria:

* Males or females between 4 and 16
* Meet the epidemiological definition of Kawasaki Disease or have a diagnosis of incomplete KD, including evidence of coronary artery disease as determined by their physician.
* Be able to exercise adequately to achieve 85% age predicted maximum heart rate

Exclusion Criteria:

* Terminal illness where expected survival is \< 6 months
Virtual Group Fitness and Nutrition Intervention for Individuals With Psychosis

Individuals with schizophrenia spectrum disorder (SSD) often face unique barriers that limit the development of long-lasting lifestyle changes. In this study, The investigators will investigate the feasibility and impact of a novel lifestyle intervention in individuals with schizophrenia or schizoaffective disorder. The intervention will be composed of group fitness instruction and educational nutrition didactics that will be accessible to participants at-home through remote streaming. The fitness component will consist of weekly group fitness sessions delivered by a certified personal trainer over a virtual interface. The educational nutritional component of this intervention will involve interactive didactic sessions designed to improve knowledge of nutrition and positively change dietary behavior in this population.


Eligibility Criteria:
Inclusion Criteria:

* Receiving outpatient psychiatric care for early-episode psychosis, schizophrenia, or schizoaffective disorder at Boston Medical Center or the Mass General Hospital
* Proficient in English
* Cleared by their primary care provider to perform 30 minutes of aerobic and strength exercise

Exclusion Criteria:

* Documented history of one of the absolute contraindications to exercise defined in the "Exercise Standards for Testing and Training" by the American Heart Association in our electronic medical record which includes the following:

  1. Acute myocardial infarction
  2. Ongoing unstable angina
  3. Uncontrolled cardiac arrhythmia with hemodynamic compromise
  4. Endocarditis
  5. Symptomatic severe aortic stenosis
  6. Decompensated heart failure
  7. Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis
  8. Acute myocarditis or pericarditis
  9. Acute aortic dissection
* Inability to ambulate independently
The Effect of Dietary Nitrate on the Oral Microbiome

This study evaluates whether dietary manipulation of the oral microbiota modulates cardiovascular health through effects on nitric oxide bioavailability.

Nitric oxide is an important molecule for human health because it controls blood flow and blood pressure. With aging, our ability to make nitric oxide gets worse and our blood pressure tends to increase. We can help the body produce more nitric oxide by supplementing the diet with vegetables, such as beetroot juice, which contains high amounts of nitrate. This has been shown to improve blood flow and blood pressure. The bacteria inside our mouths play an important role in helping convert the ingested nitrate to nitric oxide. The reason for this study is to find out whether there are differences in oral bacteria between young and older adults, and how the oral bacterial community and blood flow and blood pressure might change when diet is supplemented with natural, nitrate-rich beetroot juice and when we use antibacterial mouthwash. This study will help us understand how the bacteria inside our mouths might be useful for keeping us healthy.

Eligibility Criteria:
Inclusion Criteria:

* Healthy young (18-30 yr) and older adults (65-80 yr)
* Male and female
* Willing to undergo the experiments as detailed in the informed consent documentation
* Willing and capable of providing written, informed consent.

Exclusion Criteria:

* Individuals receiving medication for pulmonary, cardiovascular, or metabolic conditions, ulcerative colitis or renal disease
* Having an active oral disease or dentures
* Having resting BP \>140/90 mmHg
* Having used antibiotics within 3 months
* Lacking willingness or capacity to give informed consent.
Effects of Consumption of Phosphatidylserine on the Cognitive Function

The main objective of this trial is to verify the effects of consumption of phosphatidylserine for 12 weeks on the cognitive function in healthy Japanese subjects.

In this study, the investigators will evaluate the cognitive function before and after the intervention. The groups to be compared are omega-3-phosphatidylserine derived from herring roe, phosphatidylserine derived from soybean, and a placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Japanese
2. Male and female
3. Subjects aged 35-65
4. Healthy subjects
5. Subjects who notice a decline in memory
6. Subjects whose scoring of Mini Mental State Examination (MMSE) is 24 or more
7. Subjects who met the inclusion criteria 1. \~ 6. and have relatively low standardized score in composite memory measured using Cognitrax at Scr (Selection of those with relatively low standardized scores will be conducted in blocks of "Subjects aged 50 or over" and "Subjects aged under 50")
8. Subjects who are judged as eligible to participate in the study by the physician

Exclusion Criteria:

1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction
2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who have dementia
5. Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues
6. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage, as part of their daily intake
7. Subjects who take supplements or foods that may improve cognitive functions, such as phosphatidylserine, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), and plasmalogen, as part of their daily intake
8. Subjects who take blue-backed fish such as sardines, mackerel, and saury for 4 days/week or over
9. Subjects who use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) as part of their daily life
10. Subjects regularly taking medications (including herbal medicines) and supplements
11. Subjects who are allergic to medications and/or the test food related products
12. Subjects who are pregnant, breast-feeding or planning for pregnancy during the trial period
13. Subjects who have been enrolled in other clinical trials 28 days before the agreement to participate in this trial or those who plan to enroll in another clinical trial during the trial period
14. Subjects who are deemed ineligible to participate by the principal investigator
Post-Operative Drainage Following Lymph Node Dissection

The purpose of this study is to determine whether the use of fibrin sealant reduces post-operative drainage following groin and axillary lymph node dissection.

Background: Fibrin sealant has been used for many years in clinical practice and has a wide range of applications including the control of lymphatic leaks and haemostasis. The physiological mechanism of action of fibrin was first described by Morawitz in 1905; fibrin sealant was first marketed in 1983.

Lymph node dissection is undertaken for the control of malignant disease - frequently malignant melanoma or squamous cell carcinoma. Following groin or axillary dissection, excessive post operative drainage may necessitate the presence of wound drains for 10 days or more. This may prolong hospital stay in some patients, and may be associated with an increased complication rate (such as wound infection).

Hypothesis: the use of fibrin sealant prior to wound closure following either groin or axillary dissection may reduce post-operative wound drainage.

Comparison: patients who require an elective groin or axillary dissection who either undergo standard wound closure or those who have fibrin sealant instilled into the surgical wound prior to wound closure.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Requiring groin or axillary lymph node dissection for malignant disease.

Exclusion Criteria:

* Patients under age 18 years.
* Patients unable to speak English.
* Patients with learning difficulties.
* Patients with mental illness.
* Prisoners.
* Other vulnerable groups.
Evaluation of the OsciPulse Rapid Cycling Compression Device Effects on Venous Blood Flow

This study will evaluate the effects on venous blood flow of the investigational device, OsciPulse system, which is an external intermittent limb compression device. The study will enroll healthy human subjects who will have their deep venous blood flow measured by vascular ultrasound during immobility, use of the OsciPulse system, and use of two reference vascular compression devices. Our hypothesis is that the OsciPulse system will create distinct patterns of venous flow, specifically at the site of venous valves, in comparison to the reference compression devices.

Enrolled healthy subjects will undergo and initial vascular ultrasound imaging procedure to locate a deep venous valve in either the sapheno-femoral junction or femoral trifurcation sites. Once the imaging valve is identified the baseline level of venous flow will be collected in 30 s video clips of 2D color Doppler videos and spectral Doppler. Next, either the OsciPulse device, or one of the two reference therapy devices, will be applied by study personnel according to the device's specific instructions. The subject will wear the device during the capture of 1 spectral Doppler clip and three 30 s 2D color Doppler ultrasound clips on both the left and right leg. Next, the remaining two devices will be applied based on instructions, and vascular ultrasound clips captured for each. Completion of this visit protocol will be the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult age ≥40 years old
* Generally healthy.
* No history of diagnosed vascular disease including: DVT, PE, VTE, peripheral vascular disease, post-phlebitic syndrome, or chronic venous insufficiency.
* Mentally alert and understand English proficiently.
* Able to give informed consent.

Exclusion Criteria:

* Skin breaks, abrasion, or irritation in the area of the limb in contact with the OsciPulse device or reference therapies.
* Severe peripheral artery or venous disease.
Uterine Doppler As StillbirthPredictor

The goal of this observational study is to define the predictive value of intrauterine fetal death for different longitudinal patterns of uterine artery Doppler indices (UtA-PI, UtA-RI and notch) from the second and third trimester of pregnancy in patients admitted with a diagnosis of intrauterine foetal death in the period January 2010-April 2020.

No changes in the obstetrical conduct of patients with MEFs are expected, since the data will be analysed retrospectively in patients in whom the event of intrauterine foetal death has already occurred. Patients will be treated according to normal clinical protocols.

The following information will be recorded for each patient

* Age
* Body mass index (BMI)
* Ethnicity
* Parity
* Method of pregnancy onset (spontaneous vs. medically assisted procreation)
* Maternal pathologies (if any)
* Any foetal pathologies
* Ultrasound parameters in the second and third trimester of pregnancy

  * Estimation of fetal weight
  * Umbilical artery Doppler (UA-PI)
  * Uterine artery Doppler (UtA-PI, UtA-RI and notch)
* Gestational age of fetal endouterine death
* Type of delivery
* Newborn and placental weight
* Histopathological findings of newborn and annexes (placenta and umbilical cord)

Eligibility Criteria:
Inclusion Criteria:

* Fetal endouterine death in single pregnancies with gestation period ≥ 24 weeks
* Obtaining informed consent form

Exclusion Criteria:

* Multiple pregnancies
Outcomes of a Game-based Educational Intervention: Healthy Kids

235 / 5.000 Investigators aimed to reduce the risk of obesity by trying a new intervention method that is role-play based, interactive and fun with age-appropriate play materials, considering that learning through play is more efficient.

It was aimed to reduce the risk of obesity by trying a new intervention method based on role-play, interactive and fun with age-appropriate game materials, considering that learning through play is more efficient.

Two schools were determined as control and intervention groups. An 8-week interactive-game-based intervention program will be applied to children in the intervention group who are at risk for obesity. The program was shaped by a physician-dietician-psychologist and a professional theater actor.

Family Nutrition and Physical Activity (FNPA) score, Food index (FI) score and BMI will be grouped for each child and a risk score will be calculated based on the total score they receive. It will be checked whether there is a decrease in this score after the training.

Eligibility Criteria:
Inclusion Criteria:

* All participants who do not meet the criteria of whether or not they agree to participate in the study will be included in the study.

Exclusion Criteria:

* neurodevelopmental delays
* metabolic disorders potentially leading to obesity
* physical disabilities
* those whose parents or guardians declined participation.