cyrilzakka/clinical-trials huggingface dataset:
Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis

It is not known how much improvement in insulin regulated lipolysis (the breakdown of triglycerides) occurs following substantial, sustained weight loss. Researchers will test the effects of inflammation and lipolysis regulation in people before and after bariatric surgery (sleeve gastrectomy) to answer these questions.

The purpose of this study is to determine whether the adipose inflammatory cell and cytokine content in Class III obesity is related to lipolysis insulin resistance and, if so, whether sustained, substantial weight loss one year following bariatric surgery reduces inflammation in parallel with improved insulin regulation of lipolysis

Eligibility Criteria:
Inclusion Criteria:

* BMI 40 - 50 kg/m2.
* Mo active physical illness that would interfere with mobility or weight loss after bariatric surgery

Exclusion Criteria:

* Type 1 or Type 2 Diabetes diagnosis or fasting plasma glucose ≥126 mg/dL
* Active coronary artery disease
* Participation in structured exercise (\>2 times per week for 30 minutes or longer)
* Smoking
* Medications known to affect adipose tissue metabolism (e.g., beta blockers, corticosteroids)
* Renal insufficiency (serum creatinine \> 1.5mg/dl)
* Chronic active liver disease (Bilirubin \> 17mmol/L, AST \> 144 IU/L, or ALT\>165IU/L)
* Pregnancy or breastfeeding.
Inflammatory Response After Muscle and Skeleton Trauma

The purpose of this study is to determine the inflammatory response after multiple trauma in humans.

Polytraumatized patients are via a systemic inflammatory response syndrome at high risk for an uneventful outcome in the posttraumatic phase. One of the main functions of the inflammatory response is the recognition and elimination of damaged tissues and microorganisms. In polytraumatized patients, a huge amount of damaged cells occurs which has to be eliminated by programmed cell death (apoptosis)without damaging surrounding tissues. It remains unclear whether, when and how an interplay of complement system, NF-kB, danger and pattern recognition receptors, apoptosis, mesenchymal stem cells and their regulation may be beneficial and harmful. Differing activation of the complement system, pro-inflammatory biomarkers and predisposing polymorphisms of response and receptor genes are expected to lead to varying outcome. Therefore, this prospective observational study will enroll n=60 polytraumatized patients with an ISS\>18 to monitor longitudinally their inflammatory response after trauma and to find out whether there is a discriminating pattern of the cross talk between complement system, biomarkers and apoptosis in patients with beneficial or harmful outcome.

Eligibility Criteria:
Inclusion Criteria:

* multiple trauma injury, injury severity score (ISS) \> 18 with

  1. isolated fractures of the extremities
  2. fractures of the extremities combined with blunt/penetrating visceral trauma
  3. fractures of the extremities combined with blunt/penetrating thoracic trauma
  4. isolated head injury with morphological changes in CCT
  5. combination of points 1 - 4

     Exclusion Criteria:
* life expectancy \< 24 hours
* participation in other trials
* ISS \< 18
* cardiopulmonary reanimation on the accident scene or dying immediately after hospital admission
* age \< 18 years
* known or suspected pregnancy
* patients with ray-treatment or chemotherapy within the last three months
Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy

The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as compared to continuation of CNI-based treatment.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 - 70 years old
* Liver transplant recipient (living or deceased donor)
* Patients in whom an allograft biopsy will not be contraindicated

Exclusion Criteria:

* Recipients of multiple solid organ transplants or patients that have already received a transplant in the past
* HCV positive patients who need an active anti-viral treatment (HCV- positive patients without active antiviral treatment are allowed)
* HIV positive patients
* Patients who are breast feeding
* Patients with a current severe systemic infection
* Presence of any hypersensitivity to drugs similar to Certican® (e.g. macrolides)
* Preexisting (i.e. not related to CNI-damage) renal dysfunction that, according to the judgment of the investigator, will not significantly improve after transplantation (i.e., for example, patients that are expected to have a cGFR below 50ml/min at 4 weeks post transplantation)
* Patients that have received Simulect prior to this study.
* Other protocol-defined inclusion/exclusion criteria may apply.
CLARIX™ 100 & CLARIX CORD 1K for Discectomy Patients

The purpose of the study is to evaluate the efficacy of CLARIX™ 100 and CLARIX™ CORD 1K as a tissue barrier when used as an annular patch in discectomy patients with low back \& leg pain when compared to traditional discectomy patient outcomes. This will be a 120 patient, prospective randomized study model over a 5 year post-operative period.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 90 years of age
* Patient is able to understand the aims and objectives of the trial and the trial procedures
* Patient is willing to give written informed consent to the trial
* Patient is able to follow up with regularly scheduled visits with and phone calls from Dr. Anderson and his research staff
* Diagnosed with lumbar protruding disc
* Suffer from radiating leg pain and low back pain that has failed a minimum of 6 months of conservative (non-operative) treatment options

Exclusion Criteria:

* Participation in clinical trial involving therapy for back pain within 30 days of screening
* Prior back surgery at the same level
* Inability to walk independently (adaptive devices such as walkers or canes are allowed)
* Relation (whether direct or indirect) to, student of, employee of, colleague of, indebted to the primary investigator, host institution or sponsoring company
* Receipt of corticosteroids, immunosuppressive agents, radiation therapy or chemotherapy within 1 month prior to visit
* Pregnancy or planning to become pregnant during study period
* Body Mass Index \>50
* Patients with chronic diseases such as Crohn's disease, severe renal failure (serum creatinine 2.5 mg/dL or subject on hemodialysis), severe hepatic insufficiency: known cirrhosis, any degree of ascites, serum transaminases more than 3 times the upper limit of normal, life expectancy of less than one year, uncompensated or uncontrolled right sided heart failure with associated edema
* Severe anemia, hemoglobin \<8.5 mg/dL
* Active, local or systemic malignancy such as lung cancer or leukemia
* Severe hypertension (systolic blood pressure greater than or equal to 200 mmHg or diastolic blood pressure greater than or equal to 100 mmHg)
* Severe hypoxia, with chronic oxygen or ventilation therapy
* History of collagen vascular disease or sickle cell anemia
* Active rheumatoid arthritis
* Systemic antibiotic therapy for any indication within 10 days of screening
Safety Study of Continuous Positive Airway Pressure Via a Nasal Mask

Upper airway obstruction (UAO) is common complication during induction of general anesthesia. The mechanism of UAO during anesthesia has not been well understood. Posterior displacement of soft palate are believed to be the primary contributing factors. The mechanism of UAO during anesthesia share many similarities with obstructive sleep apnea (OSA). Since nasal continuous positive airway pressure (nCPAP) can maintain the airway patent in patients with OSA, the investigators hypothesize that nCPAP during induction of anesthesia will reduce the incidence and severity of UAO.


Eligibility Criteria:
Inclusion Criteria:

Patients,between 18-65 years of age meeting ASA physical status classification I-II requiring general anesthesia for elective surgery who are able to breathe through both their nose and mouth while awake.

Exclusion Criteria:

1. Patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or American Society of Anesthesiologists physical status class III or greater.
2. Abnormal vital signs on the day of admission for surgery \[heart rate (HR, \> 100 bpm or \< 40 bpm), blood pressure (BP, \> 180/100 mmHg or \< 90/60 mmHg), room air transcutaneous oxyhemoglobin saturation (SPO2) \< 96%\] that are not correctable with his or her routine medication or commonly used pre-operative medication.
3. Unable to open mouth (\< 2.5 cm) or unable to breathe through their mouth or nose.
4. Subjects with a beard, an abnormal facial structure or other factors precluding obtaining a viable face mask fit without air leak. Also, subjects having claustrophobia that can not tolerate the mask.
5. Any person with an anticipated difficult airway. This will include subjects who require or may require either a fiberoptic intubation or intubation while awake and subjects with known OSA or body mass index (BMI) greater than 35 km/m2.
6. Gastric-esophageal reflex or a full stomach.
7. The subject has remained in bed for more than 24 hours.
8. Neurological symptoms associated with neck extension, a neurological deficit from a previous stroke or spinal cord injury, a recent stroke or transient ischemic attack (TIA) within 2 weeks.
9. Pregnant women and women less than one month post-partum. Ruling out pregnancy will be conducted by careful history and physical examination as performed routinely prior to surgery. If the history is believed to be unreliable, the patient will be excluded unless a pregnancy test is performed and the result of the test is negative.
10. Emergency cases and subjects who have not adhered to the ASA NPO (Nil Per Os) guidelines.
Smart Diabetic Foot Care Application

This study developed an app for the guidance of home-based diabetic foot care to explore its impact on patients' foot assessment awareness and self-care behavior after using this app. The study also assessed the app's effectiveness in cultivating behavioral habits that are effective in managing diabetes.

Diabetes is a common chronic metabolic disease worldwide. Approximately 50% to 60% of ulcers caused by diabetes become infected, and moderate to severe infections can lead to lower limb amputation. Among amputees, the five-year mortality rate exceeds 70%.Smart devices (mobile phones, computers, etc.) are indispensable necessities to modern lives. Downloadable mobile health applications (mHealth Apps) on smartphones are widely used in medical care . The use of these apps on smartphones has created a new field in the health industry known as mobile health

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of type 2 diabetes .
2. Aged between 20 and 80 years.
3. Able to use mobile apps or tablets for health management .

Exclusion Criteria:

1. Patients who were unconscious, had delirium, were bedridden, had cognitive impairment, or were unable to perform daily self-care.
2. Patients who refused to participate.
Developing Methods for Reconstructing Electrical Heart Activity

Non-invasive reconstruction of electrical heart activity can yield important scientific and clinical insights in cardiac rhythm disorders. In this study, The investigators aim at developing methods for reconstructing electrical heart activity non-invasively, and to use these methods to investigate cardiac rhythm disorders to answer clinical and scientific questions.


Eligibility Criteria:
Overall Inclusion Criteria:

* 18 years or older
* able to provide informed consent
* Conditions that might alter electrical conduction properties in the heart, including (but not limited to): Brugada syndrome (BS), Arrhythmogenic right ventricular cardiomyopathy (ARVC), demonstrated ventricular arrhythmias (resuscitation, (non)sustained ventricular tachycardia, ventricular fibrillation)
* Implanted cardiac device, such as pacemaker or implantable cardioverter defibrillator

Additional Inclusion Criteria for group 1 (CT group):

- Existing medical indication for a cardiac CT scan unrelated to this research

There are no additional inclusion criteria for group 2 (no-CT group).

Exclusion Criteria:

- Known strong reaction against electrode attachment
Effects of Adding Triamcinolone Acetonide to Conbercept Treatment for Refractory Diabetic Macular Edema (CONTE)

This study aimed to compare intravitreous conbercept alone with conbercept plus intravitreous triamcinolone acetonide in DME eyes which showed limited response to anti-VEGF treatment after one injection.

Some eyes with diabetic macular edema (DME) were not sensitive to anti-vascular endothelial growth factor (anti-VEGF) therapy and required continuous injections. Delayed control of macular edema might cause irreversible function loss. To predict the response to anti-VEGF treatment according to the CST change after one injection was proved reasonable recently. Adding intravitreous corticosteroids to the treatment regimen at early time might result in better outcomes than anti-VEGF therapy alone. Patients with diagnosis of refractory diabetic macular edema, confirmed by fluorangiography and optical coherence tomography (OCT), with limited response to one intravitreal anti-VEGF injection will be enrolled in the study. The enrolled patients will be randomized for the addition or not of the triamcinolone to intravitreal therapy.

Eligibility Criteria:
Inclusion Criteria:

* Type II diabetes
* Vison decrease was mainly caused by diabetic macular edema (DME)
* BCVA of 20/800 to 20/40 (decimal)
* Central subfield retinal thickness (CST) ≥ 300μm by optical coherence tomography (OCT) in the study eye
* Pan-retinal photocoagulation finished at least 3 months ago, or no pan-retinal photocoagulation is expected in the next 6 months
* Within the last 3 months, one intravitreous injection of anti-VEGF agent was performed, the CST reduction one month after injection was ≤ 20%.

Exclusion Criteria:

* Non-DME related macular edema, or edema control would not benefit the vision (for example, macular atrophy)
* Exist of other reasons of macular edema, retinal vein occlusion, uveitis, iris rubeosis, high myopia
* Ocular media opacity of insufficient quality to obtain OCT images and fundus images in the study eye
* Intraocular or periorbital injection of steroids within the last 3 months
* Macular grid photocoagulation within the last 4 months
* History of vitrectomy
* History of scleral buckle within the last 4 months, or intraocular surgery is expected in the next 6 months
* Any sign of ocular infection, including conjunctivitis, hordeolum, dacryocystitis
* Myocardial infarction, heart failure, stroke, or transient ischemic attack within one month
* Pregnant or breastfeeding women
* Uncontrolled hypertension, or blood pressure \>180/110
* Patients with uncontrolled hyperglycemia, or Hemoglobin A1C (HbA1c) ≥10.0%, or under hemodialysis , or started insulin usage within the last 4 months, or expected to start insulin use for hyperglycemia control in the next 4 months
* Those cannot follow visits on time
Feasibility of Telehealth Palliative Care and Digital Symptom Monitoring for Patients With Acute Myeloid Leukemia

AML is the most common leukemia diagnosed in adults. In spite of recent low-intensity therapies that have improved outcomes for older AML patients, AML remains associated with poor prognosis as well as high symptom burden. While the benefits of early palliative care as well as electronic PROs have been well-described in the oncology population, neither have been well-studied in the AML population, and have never been studied in combination. We propose a prospective, single-center, single-arm trial to evaluate the feasibility of a virtually-mediated supportive care model utilizing both electronic PROs and palliative care for patients with AML being treated with low-intensity therapy.

AIM1: is to evaluate and describe the feasibility of implementing early specialty palliative care referrals carried out via telehealth/video-based modalities in combination with digital symptom monitoring for patients recently diagnosed with acute myeloid leukemia (AML) and starting low intensity induction therapy.

AIM2: study the differences in health-related quality-of-life (HRQoL) metrics using patient-reported outcomes (PROs) in patients recently diagnosed with AML and starting low intensity induction therapy who receive early referral to telehealth/video-based palliative care visits compared to standard care.

AIM3: to explore the patient experience of patients with AML on low-intensity therapy, capture rates of advance care planning, hospice utilization, and hospital utilization.


Eligibility Criteria:
Inclusion Criteria:

* Patients being treated for a diagnosis of acute myeloid leukemia at Stanford Cancer Center
* Patients determined to be candidates for low intensity induction therapy (not requiring hospitalization to administer treatment) by their leukemia physician
* Estimated life expectancy of 6 months
* Functional status at the level of at least being capable of limited self-care, confined to chair or bed for half the day or better
* Access to smartphone, tablet, or computer with capability to utilize a symptom tracking application

Exclusion Criteria:

* Relapsed or refractory AML
* Patients who have established care with palliative care previously
* Non-English-speaking, as the Noona application is developed in the English language
A Study to Evaluate the Use of Placenta Protein 13 (PP13) in the First Trimester of Pregnancy as a Diagnostic Aiding Tool in the Assessment of the Risk for Developing Preeclampsia in Women With Low and Unknown Risk

The purpose of this study is to evaluate whether it is possible to detect changes in the concentration of PP13 in the blood of pregnant women who may go on to develop the complication of preeclampsia later on in the pregnancy, and if these changes can be detected early enough to allow early diagnosis and treatment for prevention of these complications and reduce their damage. This study will test if the PP13 biomarker during the first trimester of pregnancy has the ability to provide assessment of risk for the development of preeclampsia that necessitates delivery before 37 weeks gestation or can predict preeclampsia before 34 weeks gestation.

After obtaining informed consent maternal demographics, vital signs, height, weight, medical history, pregnancy dating, dipstick for urine protein, previous lab results, nuchal translucency results and uterine artery Doppler results (if done) will be obtained. Blood for PP13 will be obtained at 7-13 weeks and optionally at 21-23 weeks. Hospitalization and delivery information will be obtained via a chart review for evidence of preeclampsia.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, pregnant females
* Singleton fetus at 7 0/7 to 13 6/7 weeks gestation

Exclusion Criteria:

* Multi-fetal pregnancy
* Mental retardation
* Known fetal anomaly or demise
* BMI \> 35, serious medical condition
Antibiogram and Biofilm Formation of Bacteria Causing Prosthetic Joint Infections Isolated From Assiut University Hospital

1. Setting of antibiogram in orthopedic department
2. Evaluate the production of biofilm in bacteria isolated from specimens phenotypically and genotypically.

Increased use of total joint arthroplasties will naturally result in a related increase in the number of prosthetic joint infections (PJIs).

PJI is a disastrous complication of orthopedic surgery, frequently leading to prolonged morbidity and increased mortality. Moreover, therapy for PJI is associated with enormous costs.

PJI results from numerous factors that lead to inability of periprosthetic immune cells to protect implant surfaces and tissues from bacterial colonization.

The most destabilizing factor is the ability of bacteria to adhere to and survive on virtually all natural and synthetic surfaces.

Once firmly attached to the surface of an implant, the microorganisms initiate "biofilm" formation, which is a complex of microbial cells embedded in an extracellular matrix composed of proteins, extracellular DNA, and exopolysaccharides, providing protection for bacteria and making them extremely resistant to the immune system and antibiotic.

An ineffective empiric antibiotic regimen can be harmful to patients while unnecessary broad-spectrum antibiotics lead to increased resistance. However, healthcare providers often select an antibiotic regimen before bacterial antibiotic sensitivities are available.

The Clinical and Laboratory of Standards Institute publishes the M39 Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guideline, which is a referenced guideline on how to create antibiograms.

The antibiogram has multiple uses, including providing guidance for empiric antibiotic therapy, monitoring changes in resistance over time, assisting in formulary decisions and supports antimicrobial stewardship programs to reduce multidrug resistant organisms and the risks of adverse drug events.

Eligibility Criteria:
1. Inclusion criteria:

   * Age above 18 years old
   * no intraarticular surgery of the respective joint prior to the index surgery.
2. Exclusion criteria:

   * Age below 18 years old
   * If the patient had any intraarticular surgery prior to the primary arthroplasty in the respective joint.
Antiretroviral Therapy and Extreme Weight

The concentration of the third agent in antiretroviral therapy \[Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI), or boosted Protease inhibitor (PI) \] is different according to the body weight or body composition and therapeutic monitoring may be necessary in overweight HIV patients.

The investigators aim at measuring the individual trough concentrations of interest \[at steady state for NNRTI and boosted PI\] in overweight and normal weight HIV+ patients.

Our primary endpoint is the individual trough concentrations of interest at steady state for NNRTI or boosted PI; Principal outcome measure: comparison of the concentrations between patients \<25kg/m2 and patients\<25kg/m2

Secondary endpoints:

* Occurrence of virologic failure
* Occurrence of clinical/biological adverse events
* Percentage of patients with concentration within the therapeutic range
* Body composition Secondary outcome measures: comparison of the occurrence of virologic failure, occurrence or adverse event, patients with concentration within the therapeutic range between groups. Correlation between body composition and concentration.

Methodology, study design:

open-labelled monocentric study.

Sample size:

It will be a descriptive experimental study involving 120 overweight subjects, 120 normal weight subjects

Inclusion criteria :

* Patients with HIV+
* Patients aged more than 18 years old.
* Patient giving its well-informed and free consent.

Study design :

Plasma concentration was performed during the usual clinical follow-up. Study duration: 12 months Duration for a patient: 1 day Investigating center and participating units: one center enrolling the patients and the lab performing drug dosages.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HIV+ receiving one of the following third agent their HAART: efavirenz, atazanavir , or darunavir
* Patients aged \> 18 years old.
* Patient giving its well-informed and free consent. Patient giving its well-informed and free consent.

Patients living in France during the study.

Exclusion Criteria:

Treatment with rifampin/rifabutin