cyrilzakka/clinical-trials huggingface dataset:
CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients

This is a prospective, multi-site, observational study with a matched control group. The primary objective is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring.

The survival benefits of solid organ transplants in the United States are well documented. Improvements in immunosuppression, better anti-microbial agents, and other aspects of ancillary care have resulted in significant improvements in short- term outcomes; however, there has been little improvement in long-term graft loss. A more recent analysis found that 65% of hospital readmissions in kidney transplant recipients had adverse drug events (ADE) considered contributory, and ADE-associated readmissions had a significantly higher hazard or graft loss and death compared to patients with readmissions not associated with an ADE. Even with knowledge of ADEs, clinicians may be reluctant to adjust immunosuppressive medications due to concerns of rejection risk during the period of medication adjustment. The OmniGrafTM biomarker panel (Transplant Genomics, Inc, Framingham, MA) includes the TruGraf® peripheral blood expression profile and the TRAC donor-derived cell-free DNA(dd-cfDNA) test, which have demonstrated a strong ability to identify immune quiescence in stable patients post kidney transplant, with a NPV of 94% when both tests are negative and a PPV of 89% for subclinical rejection when both tests are positive. Because of the strong "rule out" capabilities of OmniGrafTM, it would be an ideal complement to real-time ADE knowledge to help guide clinicians' decisions to adjust, or not adjust, the immunosuppressive regimen, and help provide a dialogue between patients and clinicians on the risk-benefit of medication adjustments. The aim of this study is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM monitoring in conjunction with patient medication-related burden monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent and HIPAA authorization;
* At least 18 years of age;
* Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;
* Between 3 months and 2 years post-transplant;
* Selected by provider to undergo OmniGraf™ testing as part of usual post-transplant care

Exclusion Criteria:

* Recipient of a combined organ transplant with an extra-renal organ and/or islet cell transplant;
* Recipient of a previous non-renal solid organ and/or islet cell transplant;
* Known to be pregnant;
* Known to be infected with Human Immunodeficiency Virus (HIV);
* Known to have active BK nephropathy;
* Known to have nephrotic proteinuria (per principal investigator); or
* Participation in other biomarker studies
Influence of ABO Blood Group on the Risk of Complications in Alcoholic or Viral C Cirrhosis?

The non-O blood group is a risk factor of deep vein thrombosis and recurrence of thromboembolic events, especially when associated with Factor 5 Leiden or prothrombin G20210A mutations. A recent study suggests that non-O blood group may promote portal vein thrombosis in non cirrhotic patients.

In addition, in general population and chronic hepatitis C, non-O blood group combined with one or the other of the above genetic abnormalities is associated with an increased risk of liver fibrosis and accelerated fibrogenesis. The suspected mechanism could be an increased procoagulant factor VIII and an increased Willebrand plasma level, due to a low ADAMTS 13 activity, the result of which is an hypercoagulable state and a microthrombotic process.

In cirrhotic patients procoagulant factors and ADAMTS 13 which are respectively increased and decreased, have be shown to be prognostic markers of hepatocellular function and portal hypertension. It has been hypothesized that the hypercoagulable state and the microthrombotic process could contribute to the worsening of the disease and enoxaparin has been shown to positively modify the prognosis of cirrhosis.

The role of non-O blood group in decompensation of cirrhosis and occurrence of complications including non-tumor portal vein thrombosis has never been studied. The investigators plan a longitudinal observational study to determine the incidence of complications in alcoholic and viral cirrhosis in case of non-O blood group compared to O blood group. The aim of this study is to determine whether ABO blood group may promote complications in alcoholic or viral cirrhosis. This is an ancillary study of two national cohorts assessing natural history and hepatocellular carcinoma risk factors in alcoholic (CIRRAL) and viral (CIRVIR) cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient with either alcoholic or viral C cirrhosis included in national cohorts CIRRAL and CIRVIR

Exclusion Criteria:

* Those of CIRRAL and CIRVIR with None Tumoral Portal Thrombosis prior history
Improvement Effect of Transcranial Direct Current Stimulation (tDCS) Applied During Exercise Training in Stroke Patients With Upper Limb and Hand Motor Function

The purpose of this study was to improve the effect of Transcranial Direct Current Stimulation (tDCS) applied during exercise training in stroke patients with upper limb and hand motor function.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 to 80 years
* Less than 58 FMA Upper scores
* Patients whose lesions do not include stimulation regions
* Patients with stroke with more than 3 months of onset

Exclusion Criteria:

* Difficult to communicate due to severe language impairment.
* Accompanied by an existing serious neurogenic disease
* Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder
* If there are difficulties in conducting the research
* Any patients who are judged by the investigator to be difficult to participate in this study
* Patients with contraindicated MRI scans
Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control

Primary Objective:

To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment.

Secondary Objectives:

* To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight.
* To evaluate the safety of Sotagliflozin 200 mg and 400 mg versus placebo.

The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of randomized treatment, and a visit 4 weeks after completion of the randomized treatment period.

Eligibility Criteria:
Inclusion criteria :

* Participants with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and documented moderate renal insufficiency defined by an estimated glomerular filtration rate (eGFR) (based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation) of ≥30 and \<60 milliliter per minute (mL/min)/1.73 meter square (m\^2) (chronic kidney disease \[CKD\] 3A, 3B).
* Participants has given written informed consent to participate in the study in accordance with local regulations.

Exclusion criteria:

* Hemoglobin A1c (HbA1c) of \<7.0% or \>11.0%.
* Type 1 diabetes.
* Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy during the study.
* Treatment with a sodium-glucose cotransporter type 2 (SGLT2) inhibitor (Canagliflozin, Dapagliflozin, Empagliflozin) during the last 12 months.
* Uncontrolled high blood pressure.
* Participants with severe anemia, severe cardiovascular (including congestive heart failure New York Heart Association IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or patients with short life expectancy that, according to the Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
* Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study of Different Types of Backache in Groups of Patients With Different Diagnoses of Degenerative Diseases

The purpose of this study is to examine whether there are relations between different types of pain in groups of patients with different diagnoses of degenerative diseases of the spinal column and their related surgeries.

In the context of this work the pain of different groups of patients should be examined by means of the painDetect Questionnaire, the Roland-Morris disability questionnaire, clinical examinations and different imaging procedures. Two groups of patients are compared with each other. Group one consists of patients with osteoporotic fractures of the vertebra. Group two is formed by patients with osteochondria , spinal disc herniation and nerval compression. Both groups of patients undergo surgery, as they are suffering from pain (e.g. kyphoplasty, nucleotomy, spondylodesis, decompression). In order to differentiate between chronic nociceptive pain and chronic neuropathic pain in these two groups the painDetect questionnaire is used. To examine the severity of disability in the patients' everyday life the Roland-Morris Disability questionnaire is used.

The included patients are examined and seen preoperative, postoperative before discharge from hospital, 6 weeks and 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Backache because of degenerative diseases
* Surgery is necessary

Exclusion Criteria:

-
Arresting Active Dental Caries in Preschool Children by Topical Fluorides

This randomized clinical trial aims to compare the effectiveness of three topical fluoride application protocols, namely three applications of a 30% SDF solution at yearly or weekly interval and three applications of a 5% NaF varnish at weekly interval, in arresting dental caries in the primary teeth of preschool children over 30 months.

This randomized clinical trial aims to compare the effectiveness of three topical fluoride application protocols, namely three applications of a 30% SDF solution at yearly or weekly interval and three applications of a 5% NaF varnish at weekly interval, in arresting dental caries in the primary teeth of preschool children over 30 months.

Preschool children attending the first year of the kindergartens will be invited to join this study. An invitation letter will be sent to the parents explaining the purpose and procedures of this study. Parental consent will be sought. Generally healthy children who have at least one tooth with untreated caries into dentine will be invited to participate and they will be followed for 30 months.

Dental clinical examination of the children will be conducted by a calibrated dentist in the kindergarten. Tooth and oral hygiene condition will be recorded. A parental questionnaire will be administered at baseline and at the 30-month follow-up visits regarding their children's socio-economic background and oral health related behaviours. The questionnaire will also assess parental satisfaction with their child's oral health and dental aesthetics.

All active dental caries lesions of the participant children will be treated if possible. The children will be categorized as having a high or a low caries rate. They will then be allocated by a stratified randomization method to one of the three study groups:

Group A - 3 applications of a 30% SDF solution at yearly interval Group B - 3 applications of a 30% SDF solution at weekly interval Group C - 3 applications of a 5% NaF varnish at weekly interval

A dental operator who is not involved in the examination of the child will apply the fluoride agents. Follow-up oral examinations will be conducted every 6 months in the kindergartens for 30 months. The status of the treated teeth and any possible side/adverse effects will be recorded in the follow-up examinations.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy children who have at least one tooth with untreated caries into dentine

Exclusion Criteria:

* Children who have major systemic diseases or on long-term medication, are uncooperative or refuse the treatment will be excluded.
Thyroid Surgery With the New Harmonic Scalpel or the Electrothermal Bipolar Vessel Sealer

The objective of this study is to compare the results of total thyroidectomy using the new harmonic scalpel device to that with the electrothermal bipolar vessel sealer.

The harmonic scalpel and the electrothermal bipolar vessel sealing system (LIGASURE PRECISE) have been both shown to be safe and effective in thyroid surgery. The moderate dissection capabilities of the previous harmonic scalpel instruments available for thyroid surgery have led to an innovative technical improvement of the device (FOCUS) that has very recently been implemented and has been made available in 2008. Comparison of the utilization of this new device, however, with the electrothermal bipolar vessel sealer has not been performed in any study. The objective of this study is to compare the results of total thyroidectomy using the FOCUS to that with the LIGASURE device in respect to hemostasis, operative time and perioperative complications. All patients undergoing a total thyroidectomy in our endocrine surgery department are randomized into those operated with FOCUS (Group A) and those with LIGASURE (Group B).

Eligibility Criteria:
Inclusion Criteria:

* total thyroidectomy

Exclusion Criteria:

* hemithyroidectomy or subtotal thyroidectomy
* additional surgical procedures together with the total thyroidectomy (i.e., parathyroidectomy or cervical lymph node dissection)
Intermittent Fasting on Body Fat and Quality of Life

The purpose of this investigator-initiated study to check the feasibility that intermittent fasting has on body fat loss and quality of life.

Start of study: Informed Consent, Body Fat Analysis, Questionnaires on quality of life, sleep, and stress. For the next four weeks, participants will eat their normal food intake with no restrictions on when to eat. Participants will keep their normal weekly exercise routine.

Midway of study: Body Fat Analysis, Questionnaires on quality of life, sleep, and stress. For the next four weeks, participants will do the intermittent fasting program. This program has participants fasting 16 hours from their last meal of the previous evening's meal to the first meal of their next day. Then for 8 hours, participants are able to eat. During the fasting, participants are allowed to consume water and black coffee/tea. Participants will also keep their normal weekly exercise routine.

End of study: Body Fat Analysis, Questionnaires on quality of life, sleep, and stress.

Eligibility Criteria:
Inclusion Criteria:

• In good health

Exclusion Criteria:

• Diabetes or Metabolic Syndrome
Methylated Genes in Blood as Biomarkers for Advanced Lung Cancer

The purpose of this study is to study whether the presence of lung cancer in your body can be detected by testing the blood, and if the results of these blood tests change as your tumor shrinks or grows.

This is a cooperative research project involving patients on the Thoracic Oncology Service at Memorial Sloan-Kettering Cancer Center, and the laboratory of Dr. Peter Danenberg, Professor of Biochemistry and Molecular Biology, University of Southern California / Norris Comprehensive Cancer Center in Los Angeles, California. The primary objectives are to measure the proportion of patients with advanced (stage III-IV) lung cancer with methylated genes in their blood, and to determine if response to chemotherapy (complete or partial radiologic response) in patients with advanced lung cancer renders methylated genes undetectable in the blood. This research project will enroll approximately 80 patients per year over 4 years to generate a sample size of approximately 320 patients.Blood will be collected from participating patients at baseline, as close as possible to the date of their baseline radiologic assessment. Three follow-up blood collections will be drawn, each within 7-10 days of each follow-up radiologic evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven advanced (stage III-IV) lung cancer
* Measurable and/or evaluable disease
* Enrollment in an MSKCC protocol of experimental chemotherapy with radiologic response rate as an efficacy outcome variable, or prescription of standard chemotherapy in which the patient will be receiving routine radiological scans (every 4-8 weeks) as standard clinical practice.
* Signed written informed consent

Exclusion Criteria:

-None
Comparison of Deep Versus Awake Tracheal Extubation in Adults

Prospective, randomized, single-blinded controlled study to compare the airway and respiratory complications of deep and awake tracheal extubations in adults.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status classification system for assessing the fitness of patients before surgery 1-3
* Meeting American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting
* Adult patients age 18-64
* Favorable airway examinations (Mallampati 1 or 2, normal mouth opening, and intact neck extension)
* Scheduled cases in which tracheal intubation and general anesthesia are indicated

Exclusion Criteria:

* Patients with chronic obstructive pulmonary disease, pulmonary hypertension, interstitial lung disease, active respiratory infections, and/or uncontrolled asthma
* Unfavorable airway examinations (Mallampati 3 or 4, limited mouth opening, and/or inability to extend neck)
* Full stomach
* Known difficult intubation or mask ventilation
* Surgeries of the airway and intrathoracic surgeries
* Emergent surgeries
* Case duration \>6 hours
* Pregnancy
* Patients scheduled to receive a protocolized anesthetic (Enhanced Recovery After Surgery aka ERAS)
* ASA Physical Status Classification 4 or 5
* Chronic diseases such as obstructive pulmonary disease, pulmonary hypertension, interstitial lung disease, active respiratory infections, and/or uncontrolled asthma
* Uncontrolled gastroesophageal reflux disease (heartburn) defined by presence of symptoms despite compliance with appropriate medication regimen
* Patient scheduled to receive a protocolized anesthetic ie Enhanced Recovery After Anesthesia (ERAS)
* Surgeries requiring prone positioning
Effect of LIK066 on Body Weight in Patients With Elevated Body Mass Index

A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and normoglycemic patients with elevated body mass index (BMI)


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects with stable health condition as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening.
* Patients with dysglycemia are patients with: Fasting plasma glucose \>100mg/dL (5.6 mmol/L), or HbA1c \> 5.7% and \< 10% at screening.
* Fasting plasma glucose ≤250mg/dL (13.9 mmol/L) at screening.
* If treated with antidiabetic medications (other than prohibited medications), patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study.
* Subjects must have a body mass index (BMI) within the range of 35 - 50 kg/m2 at screening, with stable body weight (± 5 kg) within 3 months prior to screening

Key Exclusion Criteria:

* Pre-existing, clinically significant gastrointestinal, liver, cardiovascular, renal or other chronic medical condition which is considered serious or unstable, other than stable cardiovascular disease, treated hypertension, dyslipidemia or other stable chronic disorders
* Clinically significant GI disorder related to malabsorption or that may affect drug or glucose absorption or history of significant gastrointestinal surgery that could affect intestinal glucose absorption
* Enrollment in a diet, weight loss or exercise programs with the specific intent of losing weight, within 3 months prior to randomization, or clinical diagnosis of any eating disorder
* Pregnant or nursing (lactating) women, and women of child-bearing potential
Pulmonary Ultrasound for the Assessment of Atelectasis in Anesthetized Children Using a Laryngeal Mask Airway.

This study will use lung ultrasounds (LUS) to evaluate the incidence and severity of intraoperative atelectasis in anesthetized children undergoing minor surgery using a laryngeal mask airway. The children will be randomly assigned to be left in spontaneous ventilation with a Positive End Expiratory Pressure (PEEP) of 5cmH2O or to be ventilated with a pressure support mode.

It is well known and described the deleterious effect that general anesthesia (GA) has on functional residual capacity (FRC), especially in children. This population is at higher risk of decreasing FRC during GA because of their lower capacity for elastic retraction and lower relaxation volume comparing to adults, predisposing them to the development of atelectasis and airway closure. These factors will lead to intrapulmonary shunts, which may impair the gas exchange and consequently oxygenation. By reducing the intrapulmonary shunt, Positive End Expiratory Pressure (PEEP) during controlled mechanical ventilation in patients with healthy lungs optimizes the FRC. However, the available data for an optimal ventilation strategy, including optimal PEEP, using a laryngeal mask airway (LMA) in the pediatric population are scarce, even though this device is frequently used in all age groups for brief general anesthesia.

Diagnosing anesthesia-induced atelectasis in the perioperative period can be possible by using lung ultrasounds (LUS), a simple, easily accessible, non-invasive and radiation free technique, which might help determine the impact in pulmonary aeration between different ventilation strategies. In our study, we will focus on comparing spontaneous ventilation (VS) with a PEEP of 5 cmH2O and pressure-support ventilation using a LMA in anesthetized children undergoing minor and elective outpatient surgery.

Eligibility Criteria:
Inclusion Criteria:

* fasted children between 12 months and 8 years of age; American Society of Anesthesiology (ASA) score I or II without lung disease; baseline pulse oximetry in room air \>96%; scheduled for minor urological surgery (circumcision) under general anesthesia; written parent's agreement.

Exclusion Criteria:

* ASA score \> II, chronic lung disease, airway infection in the last 15 days, impossibility of insertion of LMA.