cyrilzakka/clinical-trials huggingface dataset:
Non-Invasive Measurement of SjvO2 Using Near Infrared Spectroscopy in Patients Undergoing Liver Transplantation Surgery

Mixed venous oxygen saturation (SvO2) is an important parameter in the management of patient during liver transplantation surgery especially during portal vein clamping. The only way to measure it is to use a pulmonary artery catheter. If the authors can show a positive relationship between invasive SvO2 measurement and noninvasive jugular venous oxygen saturation (SjvO2) measurement with VO 100 medical device, it will possible to use SjvO2 as a noninvasive surrogate of SvO2 in patients during liver transplantation surgery.

SvO2 measures mixed venous oxygen saturation from the lower and upper half of the body. To be measured, Sv02 requires a central venous catheter. SvO2 gives knowledge about the balance between the delivery of oxygen and oxygen consumption in the body. Interest in SvO2 monitoring in anesthesia and critical care has been debated. However, SvO2 is still recommended as a major hemodynamic target of early resuscitation of critically ill patients. SvO2 measurement through pulmonary artery catheter is accompanied with morbidity due to its invasiveness. During liver transplantation surgery, measurement of SvO2 is required to adequately manage hemodynamics of the patient, especially during portal venous clamping.

VO 100 medical device from Mespere LifeSciences allows a non-invasive measurement of SjvO2 using the NIRS technique. Jugular venous oxygen saturation (SjvO2) is a measurement of the amount of oxygen left in the venous system after the brain has removed the oxygen that it needs.

On the same principle that a positive relationship between ScvO2 and SvO2 has been shown, what the investigators are trying to do is to show a positive relationship between SjvO2 and SvO2 in order to possibly use in the future SjvO2 measured by VO 100 as a noninvasive surrogate of SvO2 during liver transplantation surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients routinely equipped with a pulmonary artery catheter just before liver transplantation surgery allowing SvO2 measurement.

Exclusion Criteria:

* Adult patients not equipped with pulmonary artery catheter for liver transplantation surgery.
Different Patterns of Target Delineation in SBRT for Locally Advanced Pancreatic Cancer

The purpose of this study is to compare the efficacy and safety of two target delineation methods in SBRT for LAPC, so as to determine whether the target delineation method based on recurrence pattern can obtain better survival benefits.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75
* Patients with a pathological diagnosis of pancreatic ductal adenocarcinoma or clinical diagnosis of pancreatic cancer after clinical multiple disciplinary team
* Patients with a clinical staging of locally advanced pancreatic cancer
* No anti-tumor treatment related to pancreas before SBRT
* Performance status is acceptable, ECOG score is 0 or 1
* Patients who voluntarily accepted the clinical trial program after informing the existing treatment plan

Exclusion Criteria:

* Patients who have previously received relevant treatments in the pancreas and its surrounding areas, such as radiotherapy, chemotherapy, and local treatment
* Severe liver and kidney dysfunction
* Obstructive jaundice
* Moderate or mass ascites
* Patients with other malignant tumors, acute infection or other severe infection
* Patients with gastrointestinal ulcers and incomplete recovery, or patients with acute peptic ulcer
* Gastroscopy or imaging examination indicates that the tumor invaded the duodenum or stomach
* Patients who have participated in other clinical trials for less than three months
* Patients who are judged by researchers as unsuitable for this clinical trial
Correlation Between ΔPP/HR and ΔSV During Fluid Challenge.

In high perioperative risk patients, guidelines suggest intraoperative haemodynamic optimization by measurement of stroke volume (SV) to guide fluid resucitation.This strategy requires an invasive monitoring and learning. Some studies tried to find SV surrogates based on haemodynamic usual parameters. In an experimental hemorrhagic shock, SV was correlated to the pulse pressure (PP) / heart rate (HR) ratio.

The investigators hypothesized that SV variations (ΔSV) would be correlated to the PP/HR ratio variations (ΔPP / HR) during fluid challenge, and ΔPP / HR would be able to detect a ΔSV greater than 10%.


Eligibility Criteria:
Inclusion Criteria:

* a suspected hypovolemia, based on clinical or paraclinical parameters.
* a fluid challenge decision at the discretion of the anaesthesiologist physician in charge of the patient.

Exclusion Criteria:

* Minor or major patient under guardianship,
* oesophageal Diseases
Veracity Surgical: A Time/Motion and Quality of Care Study

This study aims to compare the time required for surgical planning using these two methods and to explore whether differences in surgical accuracy can be identified in a small study of 40 patients.

This study aims to compare the time commitment for surgical planning using these two methods and to explore whether differences in surgical accuracy can be identified in a small study of 40 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age with upcoming cataract surgery. At least 25% of enrolled eyes must be post-refractive, and 25% must require astigmatic planning (arcuate incision or toric IOL)
* Patients with otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence refractive outcome or interfere with postoperative refraction accuracy.

Exclusion Criteria:

* Patients with visually significant comorbidities (corneal, retina, optic nerve disease, not including prior refractive surgery) that could significantly affect their ability to have accurate preoperative biometry or postoperative refraction.
* Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.) that would interfere with postoperative refraction.
* Patients with \> grade 2 or greater posterior capsule opacity
Analysis of a Biomarker Signature in Patients With Multiple Sclerosis (MS) Treated With Gilenya (FTY720)

This study investigates whether there is a link between disease activity/progression in patients receiving Gilenya and expression of a putative biomarker signature in patients with multiple sclerosis.

Gilenya modulates expression of the sphingosine-1-phosphate receptor and inhibits egress of several lymphocyte subsets from lymph nodes. This results in immunosuppression that has a beneficial effect in patients with multiple sclerosis.

Our laboratory reported that increased expression of a possible biomarker signature, consisting of TLR2, TLR4 and CCR1, in a T-subset is associated with rapid MS progression. The investigators will test whether a significant proportion of patients at baseline upregulate this biomarker signature in one or more T-subsets, whether expression of this biomarker signature changes with treatment with Gilenya and whether expression levels of this signature predict disease activity or progression over a 12 month followup period. The investigators will study patients who are already being treated with Gilenya by their neurologists or who are already being treated with Gilenya as part of a clinical trial sponsored by Novartis Pharmaceuticals Canada. Patients will not be treated with Gilenya for the purposes of our study.

Eligibility Criteria:
Inclusion Criteria:

* Treatment with Gilenya

Exclusion Criteria:

* Subject is under 18 or over 65.
* Subject has less than 4 weeks of discontinuation with steroid treatment for a relapse.
* Subject cannot communicate reliably with investigator.
* Vulnerable subjects exclude, namely patients defined as those without freedom by the law (e.g. prisoners or by administrative decision) or people hospitalized without their consent.
Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/CBCT)

The objective of this research is to evaluate functional validation of the CBCT-US fusion for the Clear Guide SCENERGY system, as well as to evaluate benefits derived from system performance.

Human subjects are proposed to validate the CBCT-US fusion aspects of the Clear Guide SCENERGY product. For these modalities, Clear Guide Medical will work with the subcontract PI to determine the appropriate clinical procedure to evaluate (1) functional validation of the fusion system and (2) benefits derived from system performance. The selected procedure must be a single-patient interaction (i.e., no follow-up visits). Clinical studies will require approval through the subcontract's IRB. The Clear Guide SCENERGY will be compared to standard clinical practice (either no fusion or an electromagnetic-based fusion system). Clear Guide Medical plans to determine sample size based upon statistical powering for a predetermined clinically-meaningful difference (delta). This delta has not been selected, because this depends on the procedure selected. The anticipated sample size is expected to be around 100 subjects (i.e., 50 per arm), per modality. Blinding will be used, where possible. Clinician-related endpoints cannot be blinded due to obvious equipment differences. Subjects will be placed into treatment group by random. Retention strategies are unnecessary, as there will not be any planned follow-up visits or activities.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing radiological, oncological, or urological intervention procedures
* Able to give written informed consent

Exclusion Criteria:

* Unable to give informed consent
* Vulnerable populations and children
Treatment of Symptomatic Bloating Using a Novel Hypnotherapy Protocol

The purpose of this research is to evaluate if hypnotherapy delivered electronically will help with bloating symptoms.

This study consists of seven pre-recorded hypnotherapy sessions that will be digitally delivered to patients on their own electronic devices via an existing digital platform provided by metaMe Health. metaMe Health is a company specialized in the delivery of digital hypnotherapy protocols. The sessions will be delivered to patients over twelve weeks in accordance with current gut-direct hypnotherapy practice. The patients must agree to have their consent and content delivered electronically and provide periodic outcomes by completing electronic symptom questionnaires. The whole study will last for 24 weeks: the initial 12-week treatment period and then an additional 12-week follow-up period.

Eligibility Criteria:
Inclusion criteria:

* Patients who meet Rome IV criteria for functional abdominal bloating/distension.
* Patients who meet criteria for other Rome IV Disorder of Gut Brain Interaction diagnoses (including but not limited to irritable bowel syndrome, functional constipation, or functional dyspepsia) may be included if bloating is their predominant symptom.
* Patients will be proficient in English language for comprehension of content.
* Patients will have reliable access to digital delivery systems for content and questionnaire access via smartphone over the course of the study and follow up period.

Exclusion criteria:

* Patients with known prior diagnosis of small intestinal bacterial overgrowth (SIBO), gastroparesis, rumination syndrome, chronic intestinal pseudo-obstruction, advanced connective tissue diseases (e.g., scleroderma), and uncontrolled inflammatory bowel disease (IBD) will be excluded.
* Patients with known disaccharide intolerances may be included if dietary restrictions are maintained during the duration of the study.
* Patients who have a history of cognitive delay, traumatic brain injury with residual deficits, history of cerebral vascular accident with residual deficiencies in cognition, dementia, shall be excluded.
* Patients with significant psychiatric illness with component of psychosis (schizophrenia, bipolar disorder), as well as severe untreated major depressive disorder with suicidal ideation will be excluded.
* Patients with substance abuse disorders and drug addiction will be excluded.
* Patients who are unlikely to comply or unlikely to benefit from psychotherapy-based interventions may be excluded at the direction of medical screening provider or principal investigator.
Multiple Oral Doses Of PH-797804 In Healthy Japanese Adult Subjects

Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when administered to healthy Japanese subjects once a day (QD) for 10 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* Japanese

Exclusion Criteria:

* Subjects with clinically significant skin lesions
* Subjects with known tuberculosis infection
Relationship Between Blood Glucose Variability and Prognosis in Critically Ill Patients

This study is to evaluate the glycemic variation using Continuous Glucose Monitoring System in patients in the intensive care unit, find out the occult hypoglycemia, and investigate the relationship between glycemic variation, especially the incidence of hypoglycemia and prognosis of patients. Meanwhile, the inflammatory factors were measured and the relationship between inflammatory factors and glycemic variation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with history of diabetes;
2. Patients without history of diabetes, but their random blood glucose≧7.8mmol/L or fast blood glucose≧5 mmol/L;
3. The patients hospitalized in care unit (ICU or CCU) for more than 48 hours.

Exclusion Criteria:

1. Patient had history of mental illness;
2. Patient was not suitable for using the CGMS;
3. blood glucose \> 22.2 mmol/L at admission.
Different Stimulation Patterns to Reduce Muscle Fatigue During FES

The main aim of this study is to investigate the effect of patterned distribution stimulation compared to conventional stimulation in reducing muscle fatigue during functional electrical stimulation (FES) following spinal cord injury (SCI).

Functional electrical stimulation (FES) is a commonly used technique in rehabilitation and often associated with rapid muscle fatigue which becomes the limiting factor in its applications. The main objective of this study is to investigate the effects on the onset of fatigue of conventional synchronous stimulation, as well as asynchronous stimulation that mimic voluntary muscle activation targeting different motor units which are activated sequentially or randomly via multiple pairs of stimulation electrodes. Three different approaches with various electrode configurations will be investigated, as well as different patterns of stimulation applied to the gastrocnemius muscle. In addition, the muscle changes during different patterns of stimulation will be evaluated in this study.

Eligibility Criteria:
Inclusion Criteria:

* incomplete spinal cord injury
* able to give informed consent
* able to sit up in a chair

Exclusion Criteria:

* female subjects who are pregnant
* significant history of autonomic dysreflexia
* unable to give informed consent
* individuals who have a cardiac history
* individuals who have significant cognitive impairment
* individuals with muscular abnormality
* individuals who have significant contractures in the lower extremities
* individuals who have a rash or infection at the site of electrode placement (gastrocnemius for both legs)
* individuals who are hypersensitive to electrical stimulation
* individuals who are presently involved in another study which has overlap with the methodology and/or outcomes of the studies
Bio-behavioral Lung Cancer Prevention Program

The overall goal of this research is to increase our understanding of the role of individual genetic differences in response to bupropion treatment and the psychobiological mechanisms by which genetic and treatment factors interact in the smoking cessation process. The ultimate objective is to provide information necessary to match bupropion vs. behavioral counseling cessation treatment to those smokers with the greatest need and likelihood of benefit. This study is a double-blind randomized placebo-controlled clinical trial of bupropion HCL (brand name Zyban) in adult male and female smokers. The factorial design includes one treatment factor (bupropion 300 mg/day + counseling vs. placebo + counseling) and several subject factors (e.g. genotype, personality). Smoking history, psychological status will be assessed at baseline and blood will be drawn for genotyping. Bupropion or placebo will be delivered over a 10-week treatment period and subjects will be instructed to quit smoking after two weeks of medication (week 3 of treatment). All subjects will also receive a 7-week group behavioral smoking cessation treatment (over an 11 week period). This study may yield information that will help clinicians identify the most effective smoking cessation treatment for a particular patient, based on his/her background.


Eligibility Criteria:
Inclusion Criteria:

Eligible smokers will be those currently smoking at least 10 cigarettes a day.

Exclusion Criteria:

Exclusionary criteria are: planning a pregnancy, pregnancy, lactating, seizure disorder, history of head trauma or prior seizure, family history of a seizure disorder, brain (or CNS) tumor, history of or currently diagnosed with bulimia or anorexia nervosa, diabetes treated with oral hypoglycemics or insulin, excessive use of alcohol or alcoholism, current addiction to opiates, cocaine, or stimulants, use of other drugs containing bupropion (e.g., Wellbutrin, Wellbutrin SR), allergy to bupropion, currently taking particular medications (e.g., monoamine oxidase inhibitor, antipsychotics, antidepressants, theophylline, systemic steroids, over-the-counter stimulants and anorectics), recently taken a MAOI (less than 14 days) or a recent discontinuation of a benzodiazepine.
Impact of Pre-pregnancy Micronutrient Supplementation on Maternal and Child Outcomes

The study evaluates the efficacy of providing weekly iron-folate (IFA) supplements or Multiple Micronutrient (MM) supplements before pregnancy in increasing birth weight and duration of gestation as well as maternal and infant iron status.

Low birth weight and anemia remain intractable problems in many developing countries despite considerable efforts to address them. Intervening with just prenatal iron-folate (IFA) supplements may not be the best approach given the substantial demands for iron by maternal and fetal tissues. Therefore, there is an urgent need to evaluate the additional contribution of prepregnancy interventions.

The study evaluates the efficacy of providing weekly iron-folate (IFA) supplements or Multiple Micronutrient (MM) supplements before pregnancy in increasing birth weight and duration of gestation as well as maternal and infant iron status.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 years old
* Currently married
* Currently living in one of the 10 communes and intends to live in the areas for 24 months following recruitment
* Plans to have children in the next year
* Agrees to participate with informed consent

Exclusion Criteria:

* Currently pregnant
* Delivered in the previous six months
* Regularly consumed IFA or MM supplements in the past 2 months
* Severe anemia (Hb \< 7 g/L)
* History of high risk pregnancy including abruptio placenta, placenta previa, gestational diabetes, pregnancy induced hypertension, coagulation disorders, thrombocytopenia or chronic vascular, renal or systemic disease and drug use
* Chronic hematological diseases, hereditary defects of red cells or hemoglobin
Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease

This trial is in high risk patients to determine the safety, tolerance and efficacy of posaconazole (POZ) vs. fluconazole in the prophylaxis against development of invasive fungal infections (IFI).

This study is designed to determine the safety, tolerance and efficacy of POZ used as prophylaxis of IFI in high-risk subjects with Grade II-IV acute graft vs. host disease (GVHD) or extensive chronic GVHD. The primary objective is to assess the efficacy of SCH56592 vs fluconazole in preventing proven or probable IFI within the time period from randomization to 16 weeks after the start of treatment with study drug.

Eligibility Criteria:
Inclusion Criteria:

* Hematopoietic progenitor cell transplant subjects with chronic or Grade II-IV acute GVHD being treated with high dose immunosuppressive therapy.
* One of the following to the subject's prior immunosuppressive regimen:

  1. at least 1mg per kg per day of methylprednisolone or equivalent,
  2. Antithymocyte globulin (ATG) for the therapy of acute GVHD,
  3. Tacrolimus, mycophenolate mofetil, or other steroid-sparing immunosuppressive regimen.
Efficacy of Sequential TACE and PVE on the Resectability of Hepatitis B Related HCC

A primary hepatocellular carcinoma (HCC) is generally regarded as unresectable if the future liver remnant (FLR)≤40％ of total liver volume in patient with underlying liver disease, such as hepatitis B. In China, TACE is the most common treatment for these unresectable HCC. Recently, PVE has been employed to enlarge the FLR of the patients so as to increase the resectability and surgical safety of major hepatectomies. In order to shut the arterio-portal shunt in the liver and control the tumor progress TACE sometimes is performed before PVE. In this study we design a randomized control trial to investigate the efficacy of sequential TACE and PVE on increasing the resectability of hepatitis B related HCC compared with TACE alone.

In China, primary hepatocellular carcinoma (HCC) is mostly a hepatitis B related disease. The liver function of these patients has been damaged, which often limit the execution of major hepatectomy. A tumor is generally regarded as unresectable if the future liver remnant (FLR)≤40％ of total liver volume in patient with underlying liver disease. In China, TACE is the most common treatment for these unresectable HCC. TACE can slow down tumor progress but has little effect on enlarging FLR. Recently, PVE has been employed to enlarge the FLR of the patients so as to increase the resectability and surgical safety of major hepatectomies. But the intrahepatic arterioportal shunt and the tumor progress has decreased the effect of PVE. In order to shut the arterioportal shunt and control the tumor progress TACE sometimes is performed before PVE. In this study we design a randomized control trial to investigate the efficacy of sequential TACE and PVE on increasing the resectability of hepatitis B related HCC compared with TACE alone.

Eligibility Criteria:
Inclusion Criteria:

1. age:20-65years old;
2. with a clinical diagnosis of primary liver cancer, with HBsAg positive,without any therapy for tumor;
3. single lesion with a diameter \>6.5cm,or multiple lesions locating within half liver or adjacent three lobe;
4. estimated liver remnant volume ≤40%
5. with a liver function of Child-Pugh class A,and ALT≤80IU/l.

Exclusion criteria:

1. reject to attend；
2. portal vein trunk has been compressed by tumor;
3. diffuse type cancer or with extensive cancer thrombus in main branches of PV,HV,IVC or bile duct;
4. with extrahepatic metastasis;
5. with obvious portal hypertension (with moderate to severe varix in esophagus and/or gastric fundus, enlarged spleen,WBC\<4×109／L, PLT\<80×109／L)
6. with diabetes
7. allergy to iodine