cyrilzakka/clinical-trials huggingface dataset:
Effects of Probiotic on Inflammation and Microbiota in Patients With NASH

Individuals with clinically identified non-alcoholic fatty liver disease will undergo baseline evaluation of IL-17 and other inflammatory markers as well as microbiome determination. The probiotic formulation VSL#3 450 Billion CFU twice daily will be administered for 8 weeks and the determination of Il-17 and microbiome will be repeated. Each subject will serve as his or her own control.

This study is designed as a prospective trial of the effects of probiotic on inflammatory and stool profiles in patients with NAFLD. These patients are actively followed by the Division of Hepatology. They will have confirmed normal liver function tests and absence of hepatitis C virus in order to be eligible for this study. Eligible subjects will be identified within the outpatient setting of the Division of Hepatology of the Northwell Health System.

Division of Hepatology 400 Community Drive Manhasset, NY 11030 516-562-4281

Candidate subjects will be identified by investigators as a part of their typical work flow. Subjects will be evaluated according to inclusion and exclusion criteria presented. Eligible patients will be provided with a packet containing study information and informed consent documents. Should a patient remain interested in study participation, informed consent will be obtained. Financial compensation will not be provided to subjects.

Forty patients with NAFLD will be enrolled.

Following enrollment and informed consent, subjects will undergo the following assessments:

1. Medical History Questionnaire
2. Current Medication List

Blood and stool samples will be obtained prior to study initiation and again after 8 weeks of exposure.

Protocol for biological sample collection:

Whole Blood Collection - Venipuncture will be performed under standard conditions. Three heparinized tubes will be obtained which each tube containing approximately 10 cc of whole blood Samples will be de-identified. Peripheral Blood Cells will be isolated from whole blood samples according to standard protocols.

Serum cytokine levels, including IL-10 and IL-17, will be assessed.

Stool Collection - Patients will be provided with stool collection kits. Samples will be de-identified. Stool samples will be preserved in a -20 degree freezer in the Division of Infectious Diseases.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Capable of giving informed consent
* Diagnosed with NAFLD as defined by the American Association for the Study of Liver Diseases (AASLD) who are treated or seen solely at the outpatient clinic at the Department of Hepatology at 400 Community Drive in Manhasset NY

Exclusion Criteria:

* Cirrhosis
* Absence of secondary causes of hepatic fat accumulation including:
* Excessive alcohol consumption
* Hepatitis C
* Wilson's Disease
* Lipodystrophy
* Starvation
* Parenteral Nutrition
* Abetalipoproteinemia
* Specific Medications: Amiodarone, Methotrexate, Tamoxifen, Corticosteroids, Valproate, Anti-retroviral agents)
* Reye's Syndrome
* HELLP Syndrome
* Inborn errors of metabolism (LCAT deficiency, cholesterol ester storage disease, Wolman disease)
Safety and Pharmacokinetic Characteristics of DP-R206 in Healthy Adult Volunteers

The purpose of this study is compare the pharmacokinetic characteristics of DP-R206 (150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Bonviva (150mg Ibandronate, qd) after oral administration in healthy adult volunteers.

The number of patient is eighty-four. Patients were randomly assigned either a Bonviva tablet(150mg Ibandronate, qd) first, DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) Second or DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) first, Bonviva tablet(150mg Ibandronate, qd) second.

Eligibility Criteria:
Inclusion Criteria:

* 20 to 55 years of healthy volunteers

Exclusion Criteria:

* Hypersensitivity Reaction about Ibandronate or other drugs(aspirin, antibiotics)
p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer

Study Hypothesis:

PANCHO is a prospective randomized, predictive marker study, evaluating the interaction between the potential predictive marker 'p53 genotype' and response to induction chemotherapy in patients with esophageal cancer considered resectable.

170 patients with measurable disease will be enrolled in this study. After testing the marker genotype (two genotypes: p53 normal or p53 mutant) patients will be stratified according to histological subtype only (adeno- or squamous cell carcinoma) and will be randomly assigned to receive 3 cycles of either 5-fluorouracil (5FU)/cisplatin or docetaxel monotherapy as neoadjuvant therapy. All patients will be rendered to subsequent surgery in order to assess both clinical and pathohistological response.

PANCHO will test the hypothesis that p53 genotype is predictive for response to chemotherapy. The study uses the marker by treatment interaction design. In this design, we assume that the status of the marker splits the whole population into two distinct groups (p53 normal versus p53 mutant).

Patients in each marker group are randomly assigned to two different treatments, and planned statistical analysis is to test whether one treatment is superior to the other within each marker group separately.

The marker information but not the treatment is blinded to the patient and the investigators.

Eligibility Criteria:
Inclusion Criteria:

* Histological verification of esophageal cancer
* Presence of T2,T3,T4 or any N1 (except M1)
* Clinically measurable lesions according to RECIST criteria
* Males and females, age \>18 to 75 or older with WHO performance status 1
* No prior tumor therapy for esophageal cancer
* No other malignancy in history within 5 years before evaluation
* Performance status of 0-2 on ECOG scale
* Medical fitness (adequate for possible esophageal resection, adequate organ function: see protocol)
* Signed informed consent
* Males and females with reproductive potential must use an approved contraceptive method. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.

Exclusion Criteria:

* Inoperability (technical or functional)
* Clinical stage cT1N0, any M1
* Treatment with any of the investigational drugs within the last 6 months
* Concurrent administration of any other tumor therapy
* Pregnancy, breast feeding
* Serious concomitant disorders that would compromise the safety of the patient or ability to complete the study
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
Remimazolam Reduces Emergence Delirium in Preschool Children Undergoing Laparoscopic Surgery by Sevoflurane Anesthesia

Emergence delirium (ED) is a manifestation of acute postoperative brain dysfunction that occurs with a relatively high frequency after pediatric anesthesia. The incidence varies depending on the diagnostic criteria used and the combination of administered anesthetic drugs. The use of sevoflurane has been identified as one of the most important risk factors. In the investigators' study，the researchers conducted the current study to investigate whether remimazolam can reduce incidence of ED.

One hundred twenty children aged 1-6 years old were randomly allocated into three equal groups. Anesthesia is induced with propofol，fentanyl and rocuronium. In group P (Placebo group), anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered. In group B (Bolus group), anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2mg/kg remimazolam is administered. In group C (continuous infusion group), anesthesia is maintained by sevoflurane and continuous infusion of remimazolam(1mg/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered. Maintain BIS values in the range of 40-60. Recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.

Eligibility Criteria:
Inclusion Criteria:

1. -with American Society of Anesthesiologists (ASA) physical status I or II；
2. -aged 1-6 years；
3. -children with weight for age within the normal range；
4. -were scheduled laparoscopic surgery by sevoflurane anesthesia.

Exclusion Criteria:

1. -children who had Abnormal liver and kidney function,Cardiovascular or endocrine dysfunction;
2. -allergy or hypersensitive reaction to remimazolam;
3. -with any organ dysfunction;
4. -recently respiratory infection, mental disorder;
5. -other reasons that researchers hold it is not appropriate to participate in this trial.
Efficacy of Oral Sucrose and Topical Anesthetics to Reduce Pain During Eye Examination for Retinopathy of Prematurity

Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. The purpose of this study was to determine the effectiveness of local anesthetic eye drops and a pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye examinations for retinopathy of prematurity.

Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. Administration of oral sucrose with and without non-nutritive sucking is the most frequently studied non-pharmacological intervention for procedural pain relief in neonates.The purpose of this study was to determine the effectiveness of local anesthetic eye drops and a pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye examinations for retinopathy of prematurity.

Eligibility Criteria:
Inclusion Criteria:

-VLBW infants \<32 weeks of gestational age

Exclusion Criteria:

* infants \>32 weeks of gestational age
* neuromuscular abnormality
* major abnormality
Does the Sara Combilizer®, an Early Mobilization Aid, Reduce the Time Taken to First Mobilise Ventilated Patients in Intensive Care?

This study investigates the impact of introducing an early mobilisation device called the Sara Combilizer on time taken to mobilise in critical care. The investigators will collect baseline data on time taken to mobilise for a period of 4 months, then following a training programme and introduction of the device for a further 4 months

Early mobility within the ICU is associated with a number of positive outcomes including reductions in ICU and hospital length of stay and better functional recovery. The exact definition of 'early' mobility is still not defined, with the actual ability to mobilize limited by a number of perceived factors.

The Sara Combilizer is a combined tilt table and stretcher chair, which allows passive transfer of patients out of bed. It is theorized the passive and safe nature of transfer may facilitate earlier mobilisation of patients within critical care. This study aimed to assess whether the introduction of the Sara Combilizer reduced time taken to first mobilize for patients mechanically ventilated for at least 5 days and at risk of ICU acquired weakness.

Patients admitted to a large UK critical care unit during the trial period and ventilated for ≥ 5 days were included in the study. Baseline data was collected prospectively for a period of 4 months. The Sara Combilizer was then introduced for a 1 month training and familiarization period, followed by a further 4 months prospective data collection.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (\>18 years) admitted to critical care and ventilated for 5 days or more

Exclusion Criteria:

* Patients with contraindications to mobilise (e.g. pelvic / spinal fractures)
* Poor prior level of mobility (\<10yards)
* Neuromuscular disease (e.g. Guillain Barre or Motor Neurone Disease)
* Mechanical ventilation \> 48 hours at another facility prior to admission
* Expected withdrawal of treatment within 24 next hours
* Patients who have already commenced mobilisation in the 1st 5 days of admission
* Obese patients who exceed the weight limit of the product (200 kg)
* Patients over 6ft5 due to restrictions of the product
* Severe neurological injury
* Lower limb amputations
INCMNSZ - Rheumatoid Arthritis Cohort

Identify Rheumatoid Arthritis patients diagnose within first 12 months since the beginning of the disease related symptoms. Initiate proper treatment according to international standards in order to achieve remission/low disease activity status.

* Provide an standardized follow up by a multidisciplinary specialized team.
* Create a biological (blood) bank to develop future research projects.
* Create a database with the clinical, serologic, radiographic and functional status patients data.
* Define comorbidities and mortality causes.
* Begin an educational program to improve patient disease self-knowledge

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old
* Fulfilled ACR 1987 classification criteria for RA
* Disease evolution of \<1 year when first evaluated, and no specific rheumatic diagnosis except for RA.

Exclusion Criteria:

* Patients with another rheumatic disease, except Sjögren syndrome.
Neuroinflammatory Response and Headache Control in Patients After Subarachnoid Hemorrhage

The purpose of this study is to determine the relationship between the Neuroinflammatory response and headache pain after subarachnoid hemorrhage.

Persistent headache is a significant medical issue that affects 20% of patients who survive an aneurysmal subarachnoid hemorrhage (SAH). This headache may last years, severely affecting quality of life. Laboratory evidence suggests that the persistent headache may be a result of a maladaptive neuroinflammatory response to the hemorrhage injury that is more vigorous than necessary. The goal of this study is to measure key immunomodulators in the blood and the cerebrospinal fluid of these patients in order to determine the magnitude and dynamics of their neuroinflammatory response. In addition, the investigators will collect and analyze observational data about the success of medications to treat headache, with a specific focus on the anti-inflammatory agent dexamethasone, in managing acute headache pain and preventing the development of persistent headaches in patients after SAH.

Eligibility Criteria:
Inclusion Criteria:

* Non-traumatic subarachnoid hemorrhage
* Age \> 18 years
* Treated with external ventricular drainage

Exclusion Criteria:

* Pregnancy or lactation
* Age \< 18 years
* Traumatic SAH
Evaluation Of Stress Response In Diabetic Hypertensive Patients

In this research, we aimed to examine salivary cortisol changes in the cognitive stress response of patients with Hypertension + Diabetes Mellitus (HT+DM) and Hypertension (HT) and to determine the differences between them.

The research was conducted by solving an arithmetic task as a stress test in 62 patients with HT+DM and HT that are being treated in the outpatient clinic of Medical Pharmacology and Clinical Pharmacology Department at Istanbul University, Istanbul Medical Faculty Hospital.

In this study, saliva samples were taken for cortisol measurement, and patients were instructed to place the cotton piece in the salivette® tubes directly into their mouths without touching it with anything, hold it for 30-60 seconds, and then insert it back into the tubes in the same way, four times total, once before arithmetic stress and three times after stress, on Tuesdays, Wednesdays, and Thursdays between the hours of 12:00-16:00.

Salivary cortisol was measured using the electro-chemiluminescence immunoassay.

Eligibility Criteria:
Inclusion Criteria:

1. Using antihypertensive treatment for the last 3 months
2. Diagnosed with Type 2 Diabetes Mellitus and taking medication for at least 3 months
3. Being between the ages of 40-65
4. Being male
5. Having signed the informed consent form

Exclusion Criteria:

1. Female gender
2. Patients younger than 40 years old or older than 65 years old
3. Uncontrolled blood pressure (SBP\>140 mmHg, DBP\>90 mmHg)
4. Using antipsychotic medication
5. Using current treatment for less than 3 months
6. Having a previous MI
7. Having a previous stroke
8. Having a lung disease
9. Having organ failure
10. Having Cushing's disease
11. Having aldosteronism
12. Failure to sign the informed consent form
A Pilot Trial of a Developmental, Individual-Difference, Relationship-Bases (DIR)/Floortime for Children With Autistic Spectrum Disorders

Thirty two children age 2-6 years are recruited into the study and the randomization will be stratified for chronological age and symptom severity into 2 main groups, intervention and control. The intervention group will receive an additional target treatment of DIR/Floortime parent training intervention, while the control group will continue on their routine care for 3 months.

Hypothesis: Children in the intervention group show much improvement in climbing the developmental "ladder" and declining in the autistic behaviors.


Eligibility Criteria:
Inclusion Criteria:

* clinical criteria for Autistic Disorders according to DSM IV
* child is 2 - 6 years of age

Exclusion Criteria:

* children with additional medical diagnosis (e.g., genetic syndromes, diagnosed hearing impairment, diagnosed visual impairment or seizures)
* children who are geographically inaccessible for follow-up visits
* their parents are not literate or known chronic psychiatric or physical illness in the parents
Collagenase Option for Reduction of Dupuytren's Contracture in Japan

To investigate the efficacy and safety of AK160 in patients with Dupuytren's Contracture.

To determine plasma concentration after the first injection of AK160 in patients with Dupuytren's Contracture.


Eligibility Criteria:
Inclusion Criteria:

* At least 20 years old when written informed consent is obtained.
* Having a diagnosis of Dupuytren's contracture and flexion contracture due to palpable cord in at least 1 non-thumb finger (20° to 100° in MP joint and 20° to 80° in PIP joint).
* Positive tabletop test result (i.e., cannot simultaneously place affected finger and palm on a table).
* Voluntary written informed consent is obtained.

Exclusion Criteria:

Patients meeting any of the following criteria will be excluded:

* Is pregnant, may be pregnant, wishes to become or could become pregnant during the study (i.e., unless acceptable contraception is used, the patient has been sterilized, or the patient is postmenopausal \[no menstrual period for at least 12 months without any other medical cause\]), or is breastfeeding.
* Has a coexisting chronic disease of the hand that could impact assessment (muscular disease, neurological disease, neuromuscular disease).
* Has received another investigational product 30 or fewer days before first injection of the investigational product.
* Has undergone aponeurectomy, aponeurotomy, needle aponeurotomy/fasciotomy, verapamil/interferon injection, or another Dupuytren's Contracture treatment of the primary joint 90 or fewer days before first injection of the investigational product.
* Is allergic to collagenase or any of the excipients of AK160.
* Has taken tetracycline derivative such as minocycline and doxycycline 14 or fewer days before first injection of the investigational product.
* Has received a collagenase product 30 or fewer days before first injection of the investigational product.
* Is currently taking or has taken, 7 or fewer days before first injection of the investigational product, an anticoagulant or antiplatelet drug (other than ≤150 mg/day of aspirin).
* Has suffered a recent stroke, hemorrhage, or other disease affecting the hands.
* Has a serious disease unsuited for the study.
* Receiving treatment for a malignancy.
* History of drug or alcohol addiction within the past 5 years or history of drug or alcohol abuse within the past year.
* Has received previously the investigational product (AK160, AA4500, XIAFLEX®, or XIAPEX®).
* Otherwise found ineligible as a subject by the investigator.
Effects of Oral Protein Load on Kidney Function in Patients Undergoing Cardiac Surgery

Acute kidney injury (AKI) occurs in approximately one-third of patients undergoing cardiac surgery (CS), and represents one of the most significant negative predictors of patient outcome in this population. In the healthy adult, a high protein meal is known to enhance glomerular filtration rate and is mediated by an increase in renal blood flow. The investigators hypothesized that preoperative oral protein load may precondition the kidneys for upcoming insults and reduce the rate of postoperative AKI and long-term renal outcome.

Acute kidney injury (AKI) occurs in approximately one-third of patients undergoing cardiac surgery (CS), and represents one of the most significant negative predictors of patient outcome in this population. To date, there is no therapy to prevent AKI. In the healthy adult, a high protein meal is known to enhance glomerular filtration rate (GFR) and is mediated by an increase in renal blood flow. The investigators hypothesized that preoperative oral protein load may induce an adaptive response of the kidneys, and precondition the kidneys for upcoming insults. In the present study, the investigators aimed to compare the prevalence and severity of AKI in patients undergoing oral high protein load of the 'Preoperative Renal Functional Reserve Predict Risk of AKI after Cardiac Operation' study to age- and gender-matched "controls" who had a standard preoperative care the day prior to surgery within the same period (November 2014-October 2015) at San Bortolo Hospital, Vicenza, Italy. Both groups were followed 1 year post-discharge to evaluate long-term renal outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects older than 18 years undergoing elective cardiac surgery
2. Subjects older than 18 years with an estimated eGFR \>60 ml/min/1.73 m2 (CKD-EPI)
3. Subjects who signed informed consent forms

Exclusion Criteria:

1. Pregnancy
2. Chronic kidney disease ≥ stage III (KDIGO criteria)
3. Preexisting acute kidney injury (as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)
4. Solitary kidney
5. Diabetes mellitus type 1
6. Recent cardiac arrest or myocardial infarction up to 7 days before surgery
7. Liver failure or cirrhosis
8. Total parenteral nutrition
9. Haemoglobin \<11 g/dl
10. Sepsis
11. History of malabsorption, chronic inflammatory bowel disease, short bowel, or pancreatic insufficiency
12. Transplant donor or recipient
13. Active autoimmune disease with renal involvement
14. Rhabdomyolysis
15. Prostate hypertrophy with International Prostate Symptom Score ≥20
16. Transcatheter aortic valve implantation
17. Active neoplasm
18. Patients who did not pause angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers or received non-steroidal anti-inflammatory drugs a minimum of 48 hours before hospital admission.
19. Patients who received intravenous radiocontrast agents within the 72 hours before hospital admission.
Sensorimotor Based Brain Computer Interface

Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for controlling electronic devices using only brain signals. Often, the computer software that analyzes mu-rhythm brain signals constantly adapts to the individual user's brain signals when the training target location is known. The investigators want the BCIs to be more universal, and not depend on knowing the target location. Therefore, the investigators will test the effect removing adaptation has on accuracy of using a mu-rhythm BCI.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Able to read text on a computer screen
* Able to understand and remember instructions concerning participation.

Exclusion Criteria:

* Unable give informed consent.
* Unable to understand and follow instructions.
* Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings.
* Known to have photosensitive epilepsy.
* Open head lesions or sores.