cyrilzakka/clinical-trials huggingface dataset:
Effect of Anti-inflammatory and Anti-microbial Co-supplementations in Traumatic ICU Patients at High Risk of Sepsis

The occurrence of sepsis in trauma patients is a very serious complication. Identifying trauma patients at high risk of sepsis was not revealed in the latest surviving sepsis campaign in 2016. Several biomarkers have been proposed for early prediction of sepsis in trauma patients as leukocyte anti sedimentation rate (LAR) and the proinflammatory cytokine monocyte chemo attractant protein-1 (MCP-1). Sepsis prophylaxis before occurrence of multi-organ failure still represents a major challenge. Vitamin D and probiotics have antimicrobial, anti-inflammatory and gut microbiota immune modulatory properties.Little is known about the effect of vitamin D and probiotics co-supplementation on the inflammatory response in trauma patients at high risk of sepsis.

Another promising strategy is the use of vitamin C in addition to thiamine. Trauma is associated with increased oxidative stress and vitamin C deficiency. High dose vitamin C is required to restore oxidant-antioxidant balance. Vitamin C and thiamine have shown promising results in treatment of sepsis. Vitamin C possesses anti-inflammatory, endothelial protective and anti-microbial effects. Thiamine is the precursor of thiamine pyrophosphate (TPP), a key enzyme in Krebs cycle.

This study will investigate effect of vitamin D and probiotics versus Vitamin C and thiamine on inflammatory response (represented by change in MCP-1 level), Sequential Organ Failure Assessment (SOFA) Score and Acute Physiology and Chronic Health Evaluation II (APACHE II) in trauma patients at high risk of sepsis. Secondary goal is to assess if the predictive ability of MCP-1 plus LAR to determine high risk of sepsis in major trauma intensive care patients and if there is correlation between LAR and MCP-1.

Eligibility Criteria:
Inclusion Criteria:

* Adult trauma patients admitted to ICU within 24 hours from trauma onset with injury severity score (ISS) ≥ 16 will be recruited after obtaining informed consent

Exclusion Criteria:

* • Patients admitted to ICU after time exceeding 24 hours from trauma onset.

  * Patients whose age is less than 18 years.
  * Pregnant female.
  * Breast feeding women.
  * Arrest within 24 hours of admission.
  * Immune deficiency or administration of immune suppressant drugs.
  * Serum calcium greater than or equal to 10 mg/dl or phosphate greater than or equal 6 mg/dl.
  * History of primary parathyroid disease.
  * Metabolic bone disease.
  * Sarcoidosis.
  * End stage renal disease.
  * receiving intermittent renal replacement therapy (RRT).
  * Failure of enteral feeding or any contraindication to enteral administration.
  * Obesity , body mass index (BMI \> 35 kg/m2)
  * Known contraindication to vitamin C or thiamine (oxalate nephropathy or known glucose-6-phosphate dehydrogenase deficiency)
Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)

The aim of the study is to evaluate early safety, clinical efficacy and long-term outcomes of mitral allografts and stented biological prosthesis in tricuspid valve replacement for primary tricuspid valve diseases.

Early safety (morbidity, mortality rate, freedom from any valve related complication) along with clinical efficacy ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), long term outcomes ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), echocardiografic assessment and MSCT scan for both groups of patients are going to be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention.

  * Intraoperative findings suggested for tricuspid valve replacement rather than repair.

Exclusion Criteria:

* Pregnancy

  * Confirmed active drug addiction
  * Progressive HIV-infection
  * HIV-infected patients with CD4-cells count less than 250
  * Patients with secondary tricuspid valve pathology (left-sided valve disease)
  * LV Ejection fraction less than 40%
Critical Treatment of Coronary Artery Disease

Identifying the critical lesion of coronary artery disease and determining the interventional plan are significant for reducing adverse cardiovascular adverse events. The assessment of critical lesion requires the consideration of plaque morphology, tissue composition, and endometrial stress which leading to rupture. In summary, accurate assessment of critical lesions has high application value. In this study, patients with critical coronary artery disease were divided into two groups: an accurate assessment group and a simple assessment group, with the aim to compare the diagnosis and treatment efficiency as well as prognosis, potential cardiovascular risk, possible "excessive" intervention.


Eligibility Criteria:
Inclusion Criteria:

Volunteered to participate in this study and signed an informed consent form;

Men or non-pregnant women ≥ 18 and ≤80 years of age;

Lesion is located in a coronary artery and stenosis is between 50-75%;

Exclusion Criteria:

Severe liver and kidney diseases (GFR\<60 ml/min/1.73m2 or CTP≥6 score);

Moderate to severe hypertension (after standard antihypertensive therapy, blood pressure higher than 160/100mmHg);

Patients with hemodynamic or electrical instability (including shock);

Coagulation disorders associated with significant bleeding tendency (eg, hypersensitivity, active bleeding, moderate or severe liver disease, GI bleed within the past 6 months, major surgery within 30 days);

Patients with ischemic stroke within one week;

Any contraindication against the use of anti-platelet drugs such as aspirin;

Platelet count less than 100 x 109/L, haemoglobin (Hb) level less than 100 g/L;

Researchers involved in the study and / or immediate family members;

Participation in another investigation drug or device study in the past 30 days before enrollment;

Involvement in the planning and conduct of the study (applies to staffs at study sites);

Suffering from serious arrhythmias include recurrent ventricular tachycardia or ventricular fibrillation;

Pregnancy or lactation or females of child-bearing potential with the plan of pregnancy in one year;
Quality Improvement Project for Reproductive Health Services in India, Phase 1

Evaluation of a quality improvement (QI) collaborative aimed at improving person-centered care (PCC) for reproductive health (RH) services.

Evaluation of a quality improvement (QI) collaborative in public facilities in Uttar Pradesh, India aimed at improving person-centered care (PCC) for reproductive health (RH) services.

Eligibility Criteria:
Inclusion Criteria for Women:

* Women aged 18-49
* Agree/consent to participate
* Delivered a baby at the facility within 7 days (or adopted a family planning method at time of visit (baseline only, not part of intervention))

Exclusion Criteria for Women:

* Not a women aged 18-49
* Did not agree/consent to participate
* Did not deliver a baby at the facility within 7 days (or adopted a family planning method at time of visit (baseline only, not part of intervention))

Inclusion Criteria for Providers:

* Agreed/consented to participate
* Staff at facility

Exclusion Criteria for Provider:

* Did not agree/consent to participate
* Not Staff at facility
Long Term Outcomes Following Hernia Repair With Mesh

The objective of this study is to establish the extent to which mesh improves quality of life and surgical outcomes following hernia repair.

This is a large scale registry of prospectively collected medical record data and self-reported outcomes for those patients undergoing abdominal hernia repair with mesh.

Eligibility Criteria:
Inclusion Criteria:

* abdominal hernia repair using mesh

Exclusion Criteria:

* less than 18 years old
Distance and Hybrid Learning for Dental Student During COVID-19 Pandemic

To assess dental student opinion about distance educational learning environment during COVID-19 Pandemic and to assess their satisfaction with Hybrid learning

Coronavirus crisis has caused disturbance in the provision of education all over the world. In Egypt institutions of higher education has taken the decision to temporarily suspend attendance in universities and to keep it closed for student during this pandemic.

Cairo university overcome this problem by avoiding gathering and facilitating the continuity of education for all through remote learning.

In faculty of dentistry Cairo university, pediatric dentistry course coordinators and instructors made modifications in their course which is taught to 5th year dental student.

These modification included continuation of lectures and group sections through distance learning, while postponing any clinical work to avoid direct contact with patient.

In the next academic year the same course was taught in different way through hybrid learning

So the aim of the study was to compare education learning environment experiences among 5th year dental students enrolled in pediatric dentistry course through hybrid learning versus distance learning and to assess students satisfaction with hybrid learning , which will spot the light on strong and weak points in order to provide better education and improve their experiences.

Eligibility Criteria:
Inclusion Criteria:

* all 5th year dental student enrolled in pediatric dentistry hybrid and distance course in Cairo university was invited to participate

Exclusion Criteria:

* incomplete questionnaire
Vitamin D in Diabetic Children

Vitamin D is so-called "sunshine vitamin",it is synthesized in the skin during exposure to the ultraviolet rays in sunlight so it has been suggested that ∼ 5-30 minutes of sun exposure between 10:00 a.m. and 3:00 p.m. at least twice per week on the skin of the face, arms, back, or legs (without sunscreen) is usually adequate for vitamin D synthesis. Vitamin D is also found in plants (mainly mushrooms and yeast) and in a few foods such as fatty fish.

Vitamin D supplement is recommended in all infants until enough formula, milk, or other food sources are ingested to sufficiently provide 400 IU/day to prevent vitamin D deficiency. Type 1 diabetes is an autoimmune disease, and the self immune system plays a central role in the destruction of the beta cell of pancrease.


Eligibility Criteria:
Inclusion Criteria:

* Age (5 years - 15 years ).
* Type 1 diabetes patients.

Exclusion Criteria:

* Patients aged more than 15 years, less than 2 years.
* Type 2 diabetes.
* Neonatal diabetes.
* Patients with any complications from diabetes.
A Registry Study on Serumal Biomarkers About Adverse Events in Patients Undergoing Coronary Artery Bypass Grafting.

This is a national registry study to determine the serumal biomarkers for prognosis of adverse events in patients undergoing coronary artery bypass grafting.


Eligibility Criteria:
Inclusion Criteria:

1. Subject undergoing coronary artery bypass grafting;
2. Age is more than 18 and less than 80 years old;
3. Male and non pregnancy female;
4. Subject who understands study requirements and agrees to sign an informed consent from prior to study procedures.

Exclusion Criteria:

1. Pregnancy female;
2. Participate in other clinical trial in the last 1 month.
3. Subject who doesn't agree to sign an informed consent from prior to study procedures.
4. Subject undergoing repeat CABG, concomitant valve or other cardiac surgery.
Dexamethasone Versus Demedetomidine Addition for Adductor Canal Block

Single-injection peripheral nerve block (PNB) is commonly used for perioperative analgesia and anesthesia. Three approaches for extending the duration of PNB include continuous PNB with catheter-based techniques, novel local anesthetics delivery systems and addition of novel adjuvants to local anesthetics.


Eligibility Criteria:
Inclusion Criteria:

* elective operation
* ASA STATUS I and II

Exclusion Criteria:

* patient refusal
* ASA status III and IV
* contraindications to local anesthesia
Digital Signals in Chronic Pain (DiSCover Project)

The DiSCover Project is a 1-year longitudinal case-control observational study. In this study, the investigators plan to collect different types of data including self-reported health outcomes and quality of life data, behavioral data from activity trackers and health and fitness apps, data from lab tests, genetic data, and environmental data. One of the goals of this study is to develop digital biomarkers for chronic pain severity, flare ups and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Resides in the United States
* Case Inclusion Criteria: Self-reported diagnosis of chronic pain and experiences moderate chronic pain as assessed by scoring at least 4 on the Numeric Pain Rating Scale
* Control Inclusion Criteria: Self-reported not having chronic pain

Exclusion Criteria:

* Less than 18 years old
* Is not able to read or understand English
The Effect of Intravenous Lidocaine and Intraperitoneal Lidocaine Irrigation on Pain After Laparoscopic Cholecystectomy

This prospective randomized study aims to comparison the effectiveness of intravenous lidocaine injection and intraperitoneam lidocaine irrigation on the relief of pain in patients undergoing laparoscopic cholecystectomy.

A total of 83 patients will be randomized into one of three groups (group C or group I or group P) based on Excel number generation.

Patients in group C will receive normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.

Patients in group P will receive intraperitoneal lidocaine irrigation with 3.5 mg/kg lidocaine and normal saline 100cc.

Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 2, 4, 8, 12, 24, 48 hours postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic cholecystectomy

Exclusion Criteria:

* mental change
* allergy to local anesthetics
Strategic Use of Big Data in Spine Surgery - Testing Digital Prediction of Outcome in Clinical Praxis

The goal of this prospective, multicenter clinical trial is to determine if the use of the postoperative outcome prediction model the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction compared to current practice.

The main questions it aims to answer are:

* Does its use alter patient-reported outcome measured by general assessment regarding leg pain and Satisfaction in lumbar spinal stenosis?
* Does its use alter patient-reported outcome as measured by general assessment regarding arm pain and Satisfaction in cervical rhizopathy?
* How does the Quality of Life in patients - who after assessment by spinal surgeon do not proceed to surgery - compare with patients with the same baseline profile who did undergo surgery?

Eligible participants will be presented with their predicted postoperative outcome generated by the Dialogue Support tool, as an adjunct to the ordinary assessment by a spine surgeon.

Researchers will compare participants with a matched control group from the Swedish Spine Register ("Swespine") to see if the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Refered to a participating clinic regarding surgery for lumbar spinal stenosis or cervical radiculopathy
* 18 years of age or older
* Magnetic Resonance Imaging (MRT) examination within the last 12 months confirming the diagnosis, concurrent with symptoms described by the referring physician
* Giving informed consent

Exclusion Criteria:

* Another condition found to be the reason for the symptoms.
* Not giving informed consent
* Need for further investigation that prevents inclusion within one month of the doctor visit.
The Relationship Between Fatigue and Physical Activity Level in Patients With Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, progressive and unpredictable disease of the central nervous system. In MS, various loss of strength, balance and gait disturbances arise in the central nervous system due to sensory and/or motor neuron degeneration. These disorders lead to limitations in individual activities and participation.

Fatigue is as reported one of the most common first three symptoms among patients with MS and affects up to 80% of the patients. Fatigue is defined as the lack of physical and/or mental energy. Sometimes fatigue can reduce the quality of life by leaving other disorders behind. The most important effect of fatigue is that individuals reduce their physical activity levels. This can lead to the inactivity-related secondary problems being added to the findings of the disease. So the physical capacities of individuals may gradually decrease.

In the literature, there are many studies showing that the level of physical activity of individuals with MS is lower than in healthy individuals. When the investigators analyze the studies that investigate the relation between fatigue and physical activity levels, it is seen that there is the single study about this subject in the literature.

As a result, additional studies are needed to investigate the level of physical activity and the factors affecting it in individuals with MS. Therefore, the investigators planned this study to investigate the relationship between fatigue and physical activity levels in patients with MS.

According to sample size calculation 37 diagnosed Multiple Sclerosis patients and 37 healthy individuals will be included.The demographic characteristics of the participants initially will be taken and Expanded Disability Status Scale score of those of MS will be recorded. Then, fatigue severity and perception, physical activity level, balance, peripheral muscle strength, functional mobility, functional exercise capacity will be evaluated. Primary outcomes are fatigue and physical activity level; secondary outcomes are balance, peripheral muscle strength, functional mobility, functional exercise capacity.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Having a diagnosis of "Multiple Sclerosis" by a specialist physician
* Relapse free in the last 3 mounts
* Having an ambulatory status (Expanded Disability Status Scale score ≤ 6 )
* No diagnosis of depression

Exclusion Criteria:

* Any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research
Pilot Study of Epoetin Alfa for Patients Having Abdominal or Pelvic Surgery for Cancer

This pilot study is looking at how well epoetin alfa, given in the immediate post-operative period, works in reducing anemia and the need for transfusions.

This is a pilot, single center, prospective, double blinded, randomized study comparing epoetin alfa versus placebo. Eligible patients will just have undergone a major abdominal operation for malignancy (esophagectomy, gastrectomy, partial hepatectomy, partial pancreatectomy, or low anterior resection of rectum) and have a post-operative hemoglobin greater than 8 g/dL and less than 11 g/dL on post-operative day #1. On post-operative day #1 patients enrolled in the study will be randomized to receive either 40,000 units of epoetin alfa or placebo. On post-operative day #8, the patients will receive an additional dose of epoetin alfa or placebo (depending on randomization assignment and Hgb level). Hemoglobin, hematocrit, reticulocyte count, reticulocyte hemoglobin, and immature reticulocyte count will be measured on days 1, 4, 8, and once between post-operative days 20 and 30. Pre-operatively and between post-operative days 20 and 30 patients will complete a quality of live assessment tool (FACT-An) to assess their fatigue related to anemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing esophagectomy, gastrectomy, partial pancreatectomy, hepatic resection, or low anterior resection of rectum for malignancy
* Patients with hemoglobin greater than 8 and less than 11 g/dL on post-operative day #1.

Exclusion Criteria:

* Patients receiving red blood cell transfusion within the first twelve hours post-operatively.
* Patients receiving epoetin-stimulating proteins within 30 days prior to the operation.
Effects of Standing on Glycemia in Prediabetic Adults

The study is a crossover, pilot trial examining the acute effects of standing on blood sugar in prediabetic, working adults. Participants will complete oral glucose tolerance testing, once while sitting and once while standing. They will also wear a continuous blood sugar monitor once while sitting at their desk for a week and once while using their desk as a sit-stand desk with a goal of standing intermittently for at least half of the work day. Physical activity levels will be measured with an accelerometer. The primary study hypothesis is that blood sugar will differ between the sitting and standing conditions for each of the tests performed.


Eligibility Criteria:
Inclusion Criteria:

* Fasting blood glucose \>100 mg/dl
* Employed full-time working at least 35 hours/week
* Able to safely begin a light physical activity program

Exclusion Criteria:

* Heart disease
* Renal disease
* Peripheral neuropathy
* Retinopathy
* PAD
* Lower limb amputation
* pregnancy
* active substance abuse
* current smoker
* psychiatric disorder
* severe visual impairment
* immune-compromised individuals,
* enrollment in a physical activity study
* use of insulin or an insulin pump
GONAL-f CONSORT (Consistency in r-hFSH Starting Doses for Individualised Treatment)

This non-interventional study (NIS) is planned to examine the consistency of the dose recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator.

Since the introduction of the first recombinant human follicle stimulating hormone (FSH) preparation Gonal-f in the year 1996, a pure drug is available as raw material, which is independent of human urine due to biotechnological methods and consequently can be produced free of contaminating proteins. In accordance with the recommendations of European Medicines Agency (EMEA) in February 1999, on the basis of data from clinical studies, Gonal-f should be regarded as the more effective preparation in comparison to urinary FSH. Serono has developed a dose calculator, the CONSORT calculator, after analyzing the data from clinical studies for Gonal-f. This non-interventional study is planned to examine the consistency of the dose recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator. All subjects, who undergo stimulation with Gonal-f in preparation for a technology of the assisted conception in accordance with the permitted indication, will be included in this non-interventional study.

OBJECTIVES

Primary Objective:

* To examine, how far the dose recommended by the doctor for the first stimulation day varies from the dose recommended by the CONSORT calculator

Eligibility Criteria:
Inclusion Criteria:

* Female subjects undergoing stimulation with Gonal-f in ART in accordance with the permitted indication
* Subjects below 35 years of age
* Subjects who have a Body mass index below 30
* Subjects with a basal FSH below 12 I.E./l and is downregulated in the long gonadotropin hormone releasing hormone agonist (GnRHa) Protocol