cyrilzakka/clinical-trials huggingface dataset:
Polymorphisms in Key Genes of Glycolytic Pathway: Influence on Radiosensitivity in Nasopharyngeal Carcinoma

Warburg effect is an important feature of tumors,and genetic variation is one of the main factors of individual differences to radiotherapy treatment response for nasopharyngeal carcinoma(NPC). Through the previous work investigators found that the p53 codon72 (Pro/Arg) was related to the prognosis of NPC; Using the method of proteomics, investigators discovered glycolysis related gene such as PGK1, ALDOA，was associated with radiosensitivity.Thus,with all the previous work,investigators hypothesize that the key gene polymorphisms in glycolytic pathway, such as p53 , influence the glycolytic pathway,which leads to differences in radiosensitivity of NPC. This projects will include 600 cases of patients with NPC to detect common glycolytic key genes polymorphisms. Besides,investigators correlate these factors with their radiosensitivity and prognosis.Then, prediction model will be established, and validation of the prediction model will be done. Using enzyme-labeling instrument ，comet assay and clonogenic assay，cytological experiments will further investigate the influence of key gene polymorphisms on the glycolysis efficiency and mechanism of radiation sensitivity.Thus,investigators could provide theoretical basis of individualized treatment for NPC.


Eligibility Criteria:
Inclusion Criteria:

* pathological identified NPC
* KPS≥70
* tolerable and agree for IMRT and concurrent chemotherapy
* without severe other diseases
* informed consent

Exclusion Criteria:

* reject treatment
* cannot tolerate the treatment
* distant metastasis before treatment
Clip-assisted Fixation to Prevent Migration of Fully Covered Self-expandable Metal Stent in Patients Undergoing ERCP

Fully covered self-expandable metal stent (FCSEMS) has been widely used in ERCP patients with malignant or benign biliary stricture, difficult CBDS, post-EST bleeding, bile leak or perforation. Compared with uncovered SEMS, FCSEMS can be removed several months later and has the advantage of longer patency. Proximal or distal migration is one of major disadvantages of FCSEMS. The migration rate ranged from 7.0%-33% in previous reports.

We hypothesized that the fixation of the distal end of FCSEMS by a metal clip could decrease the migration rate and migration-related cholangitis.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80
2. Patients with ERCP indications who were suitable for FCSEMS placement, such as benign or malignant biliary stricture, difficult CBDS, biliary or papillary bleeding, bile leak or perforation etc.

Exclusion Criteria:

1. Expected life span ≤6 months
2. Considering tumor resection within 6 months
3. Failed CBD cannulation
4. Hilar stricture (Bismuth II, III and IV)
5. CBD dilating by a balloon catheter with diameter≥8mm
6. Inserting the whole FCSEMS into CBD and the distal end of FCSEMS invisible in endoscopic view
7. Maximal CBD diameter ≤6mm
8. Pregnancy or lactation
9. Unable to provide informed consent
Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis

To evaluate the safety and efficacy of tocilizumab in the treatment of generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study tMG(NCT05067348).

tMG-E was an extension study designed to provide the participants who completed Study tMG an opportunity to receive tocilizumab and collect clinical data to provide long-term safety and efficacy information on tocilizumab in participants with gMG.

After receiving blinded study treatment (tocilizumab or placebo) in Study tMG for 16 weeks, participants were eligible to enroll in the tMG-E extension study. Participants were to enter Study tMG-E within 8 weeks after completing their Week 16 visit in Study tMG.

Study tMG-E consisted of an Open-Label treatment Phase up to 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Participant has completed Study tMG.
2. Participant has given written informed consent.
3. MG-ADL score ≥ 5 points, or a decrease of ≤ 3 points relative to the baseline MG-ADL of the tMG study

Exclusion Criteria:

1. Participants had clinically relevant active infections (such as sepsis, pneumonia, or abscess) or severe infections (resulting in hospitalization or requiring antibiotic treatment) in the past 4 weeks;
2. Those with high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis after the tMG study;
3. planned thymectomy during RCP;
4. Received IVIG or plasma exchange in the past 4 weeks;
5. Any medical condition or circumstances that, in the opinion of the investigator, might have interfered with the participant's participation in the study, posed any added risk for the participant, or confounded the assessment of the participants.
TODAY2 Phase 2 Follow-up

The primary objective of T2P2 is to track the progression of T2D and related comorbidities and complications in the TODAY cohort as they transition to young adulthood. We hypothesize that:

* Youth-onset type 2 diabetes (T2D) will progress rapidly and result in high rates of diabetes-related medical complications and comorbidities.
* The rapid rate of progression is related to increased insulin resistance characteristic of puberty, worse β-cell function, degree of glycemic control, control of non-glycemic factors, and obesity itself.


Eligibility Criteria:
Inclusion Criteria:

* Participated in TODAY clinical trial.

Exclusion Criteria:

-
Pilot Mobile for Dementia and Frailty

In this project, we propose to build on our Stage I formative work (according to the NIH Stage Model for Behavioral Intervention Development), where we developed fully functional prototypes of a mobile intervention aimed at improving adherence to Mediterranean Diet (MedD) for older adults with frailty and early dementia to complete the Stage II exploratory work, where the intervention will undergo further feasibility, acceptability, and preliminary efficacy tests. The intervention includes a patient-facing app that allows users to track their diet and receive personalized feedback concerning opportunities for improvement and recipes for breakfast, lunch, dinner, and snacks, informational materials about MedD, and a chat feature. On the other end, a web-based provider interface allows clinicians to review patient progress, suggest meal plans, and send and receive messages. The pilot randomized controlled trial, conducted over three months, will compare usual care to usual care plus mobile intervention to gather preliminary efficacy data concerning a change in adherence to MedD score (primary outcome). Mechanistic and secondary outcomes will include MedD knowledge, constructs from Social Cognitive Theory (self-efficacy, outcome expectation, self-regulation, and social support), platform use, anthropometric, and functional measures. Feasibility will be evaluated in terms of recruitment and retention outcomes. Acceptability will be determined through post-intervention semi-structured interviews and structured survey measures.


Eligibility Criteria:
Inclusion Criteria:

1. 65 years or older;
2. ICD-9-CM (ICD-10-CM) codes for mild or major neurocognitive disorders with mild-to-moderate severity due to several possible etiologies. Specifically, a) mild neurocognitive disorder 331.83 (G31.84); major neurocognitive disorder 294.1x (F02.8x) due to Alzheimer disease 331.0 (G30.9); frontotemporal lobar degeneration 331.19 (G31.09); Lewy body disease 331.82 (G31.83);
3. mild-to-moderate frailty
4. own a mobile device.

Exclusion Criteria:

1. Severe sensory impairment that makes it impossible to operate a mobile device or respond to prompts
2. English reading level below 6th grade
3. no care partner
4. optimal diet
Impact of a Financial Success Education Program in Women and Children

Many Americans are living paycheck to paycheck. This may lead to financial stress and an increase in overall stress. People under stress are more likely to smoke, consume alcohol, eat a poor diet, and experience depression or anxiety. Experiencing financial stress may also increase the risk for heart disease. The purpose of this research study is to test whether participating in the Financial Success Program improves health outcomes, in both the women participating and their children.


Eligibility Criteria:
Inclusion Criteria:

* Women 19 years or older enrolled in the Financial Success Program in fall 2011 and winter 2012 and/or a their child(ren) ages 3-18 years attending the daycare with their mother
* Women must be employed to be enrolled in the Financial Success Program
* Able and willing to provide informed consent

Exclusion Criteria:

* Women less than 19 years of age
* Women working a night time shift (due to variability in diurnal cortisol secretion)
* Known pregnancy or planned pregnancy (due to variability in blood pressure, glucose, weight, and lipids)
* Women are excluded from the Financial Success Program if they are living in a domestic violence situation or abusing alcohol or illicit drugs
Drug-Drug Interaction (DDI) Study for TPN171H

The primary objective of this study was to assess the effect of rifampicin,a cytochrome P450 3A4 enzyme (CYP3A4) induction, on the pharmacokinetics (PK) of TPN171H in chinese healthy male subjects ,and assess the effect of itraconazole，cytochrome P450 3A4 enzyme (CYP3A4) induction on the PK of TPN171H in chinese healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects between the ages of 18 and 40 years;
2. Body Mass Index of 19 to 26 kg/m2; Body weight no less than 50 kg;
3. Physical examination, vital signs examination, ECG, laboratory examination results were normal or abnormal without clinical significance;
4. Take reliable contraceptive measures during the trial and within three months after taking the drug;
5. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and can complete the whole trial process according to the test requirements.

Exclusion Criteria:

1. Allergies to test preparations, any of their ingredients, and related preparations; With allergies or allergic diseases;
2. Clear diseases of the central nervous system, cardiovascular system, digestive system (including those with severe fatty liver in B-ultrasound examination), respiratory system, urinary system, blood system, metabolic disorders, etc. and require medical intervention or other unsuitable clinical trials Those with tested diseases (such as history of mental illness, etc.); those with a history of orthostatic hypotension;
3. Blurred vision or a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinal degeneration (such as retinitis pigmentosa), macular degeneration;
4. A history of postural hypotension;
5. Patients with blood loss ≥400 mL within 3 months before inclusion;
6. Taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 2 weeks before administration;
7. Participated in other drug clinical trials and received trial drugs within 3 months before administration;
8. Positive results of alcohol breath test, or current/previous alcoholics (drinking more than 21 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL wine);
9. Smoking more than 10 cigarettes per day ;
10. Positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;
11. Patients with clinically significant Chest x-ray (posterioranterior) abnormalities;
12. The investigator believes that there are other factors that are not suitable for participating in this trial.
Predictive Factors of Recurrence of Non Functioning Pituitary Adenomas : a Retrospective Study of 220 Patients in the Reims University Hospital, France

Non functioning pituitary adenomas (NFPAs) are the most common pituitary adenomas. Their growth is usually slow and diagnosis is often made in the context of masse effect .The therapeutic alternatives are surgery and radiotherapy such as fractionated stereotactic radiotherapy. Nowadays, there is no clinical or histological prognostic factor to allow an individualized follow-up and recurrence could happen 10 or 15 years after the first surgery. In this study, the investigators evaluate NFPAs recurrence rate after surgery and try to find predictive factors of recurrence to personalized the follow-up of each patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 year-old
* diagnosis of NFPAs confirmed with hormonal and histological analysis
* patients who underwent surgery in neurosurgery unit of the Reims university hospital between 01/01/1991 and 31/12/2004

Exclusion Criteria:

-
Genetic Profiling of Liver Cancer in Patients Undergoing Liver Transplantation

The purpose of this study is to determine whether genetic markers unique to liver cancer are present and to assess usefulness as a diagnostic tool.

Hepatocellular carcinoma (HCC) is the most common form of liver cancer and a growing trend worldwide. Decision-making regarding treatment for patients is limited by the lack of clinically actionable biomarkers. This is pronounced in the case for determining and monitoring liver transplant recipients. In an effort to improve diagnosis, the use of circulating serum-based microRNA isoforms (isomiRs) can serve as non-invasive, screening biomarkers in HCC patients pre- and post-transplantation of the liver.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of HCC who are on the wait list for liver transplantation
* Patients with the diagnosis of HCC who have been admitted to hospital, scheduled to undergo liver transplantation within the following 24 hours.
* Age Range: 18 to 75 years old

Exclusion Criteria:

* Patients with metastatic HCC and patients with the diagnosis of HCC who are not on the wait list for liver transplantation.
* Patients older than 75 years old and younger than 18 years old.
* Patients who are unable to consent.
* Pregnant patients.
Immunohistochemical & Immunoblot Analysis of NIS (Na+/I-Symporter) in Archival & Frozen Tissue Sample

The goal of this study is to study NIS expression in benign and malignant breast and thyroid samples using archival formalin-fixed paraffin-embedded tissue sections.

The objective of the study is to further understanding of proteins that occur in both normal cells and tumor cells and to learn more about certain diseases and potential alternative treatments for these diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must be over the age of 18.
2. Patients must have benign and malignant breast and thyroid cancer.
3. Patient mus sign consent form.

Exclusion Criteria:

1. No children will be allowed.
Efficacy Study of Acupuncture to Treat Spinal Pain

This study is being conducted to investigate the effectiveness and safety of acupuncture for alleviating pain of spondylosis.

This study is being conducted at the Daegu Catholic University Medical Center. Enrolled participants will be randomized into two groups : acupuncture treatment plus epidural block and epidural block alone.

This trial will include treatments during 3 weeks, and then follow up after 2 weeks. Participants will have acupuncture treatments of three times per week and epidural block of once per week. All examinations and treatments will be provided free of charge. Compared with epidural block group, acupuncture plus epidural block group will give more effectiveness for alleviate pain caused by lumbar spondylosis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years
* Meyerding Grade I-II spondylolisthesis
* Low back pain of at least 1-year duration
* Follow-up possible during the clinical trial
* Written informed consent voluntarily

Exclusion Criteria:

* Cauda equina syndrome, persistently exacerbated symptoms, progressive neurologic signs (sensory or motor changes)
* Previous spine surgery
* Senile dementia, impaired cognitive function or other cerebral disease, severe psychiatric or psychological disorders
* Severe, concomitant disease (neuromuscular scoliosis, neurodegenerative disease)
* All contraindications to corticosteroid injection (e.g., insulin-dependent diabetes)
* Alcohol/drug abuse
* Significant renal or hepatic disease
* Pregnant, lactating or planning a pregnancy
* Hypersensitive reaction to acupuncture treatment
* Inability to comprehend or express oneself in the Korean language
* An individual deemed to be ineligible by a physician
* Refusal to participate in the trial or to provide informed consent
Glycemic Responses and Sensory Characteristics of Whole Yellow Pea Flour Added to Novel Functional Foods

The objective of this study was to determine if whole yellow pea flour reduces post-prandial glycemic responses of novel food products. The second objective was to determine if whole yellow pea flour produces food products with favorable sensory characteristics including appearance, taste, smell, texture and overall acceptability, compared to corresponding food products made with whole wheat flour.

Pulses, including yellow peas, are readily available and low-cost commodities that are gaining considerable momentum as functional ingredients possessing health benefits, as these food materials are high in fiber, protein, antioxidants, and low in fat. As incidence rates of type II diabetes continue to climb, new novel ingredients that produce low-glycemic food products are in demand. Consumption of whole pulses have been shown to lower post-prandial glycemic responses (Jenkins and others 1983), however, their addition to foods often produces unfavorable sensory characteristics. To date, few studies have examined the feasibility of producing food products containing pulse-derived ingredients that reduce post-prandial glycemic responses, lower glycemic indexes (GI) and at the same time possess sensory qualities that appeal to consumers. Since yellow peas are readily available and relatively inexpensive, they are a promising candidate for use as novel ingredients for the development of low-glycemic, consumer-friendly functional foods.

The objective of the present study was to first determine the post-prandial glycemic response and GI of novel foods containing whole yellow pea flour (WYPF) as a functional ingredient. The second objective was to determine the acceptability of sensory characteristics for each WYPF food product.

Eligibility Criteria:
Inclusion Criteria:

* healthy men
* non-lactating women
* BMI's between 18 and 31 kg/m2

Exclusion Criteria:

* heart disease
* diabetes
* thyroid disease
* celiac disease
* gluten intolerance
* taking corticosteroid medications
* smokers
* Chronic alcohol usage (\> 2 drinks/d)
The Clinical Significance of Portal Hypertension After Cardiac Surgery: a Multicenter Prospective Observational Study

Portal flow pulsatility detected by Doppler ultrasound is an echographic marker of cardiogenic portal hypertension from right ventricular failure and is associated with adverse outcomes based on previous studies performed at the Montreal Heart Institute. This multicenter prospective cohort study aims to determine if portal flow pulsatility after cardiopulmonary bypass separation is associated with a longer requirement of life support after cardiac surgery.

Hypothesis: Portal flow pulsatility detected by Doppler ultrasound during cardiac surgery is an echographic marker of cardiogenic portal hypertension from right ventricular failure and is associated with adverse clinical outcomes.

Background: Peri-operative right ventricular failure is associated with a high mortality rate. In this context, organ perfusion is hampered by both the reduction of cardiac output and venous congestion from the elevation of central venous pressure. The clinician's objective is to appreciate the hemodynamic impact on end-organs in an effort to adjust the therapy accordingly since the ultimate goal is to optimize their perfusion. Based on this rationale, organ specific blood flow assessment using Doppler ultrasound could be used to personalize management. In order to non-invasively assess the presence of cardiogenic portal hypertension, Doppler ultrasound can be used to detect portal flow pulsatility, an abnormal variation in the velocity of blood flow within the main portal vein. In two single-center cohort studies, the presence of portal flow pulsatility after cardiac surgery was independently associated with post-operative complications such as major bleeding, acute kidney injury (AKI) and delirium as well as increased length of intensive care unit (ICU) stay.

Specific Objectives: This multi-center cohort study aim to determine whether the association between portal flow pulsatility and organ dysfunction seen in previous studies is present across multiple cardiac surgery centers.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years old) and able to give informed consent undergoing cardiac surgery with the use of CPB for whom peri-operative TEE is planned.
* High surgical risk defined as at least one of the following:

  1. Multiple surgical procedures planned
  2. EuroSCORE II ≥ 5%
  3. Known pulmonary hypertension (mPAP\>25mmHg or sPAP\>40mmHg).

Exclusion Criteria:

* Patient with a critical pre-operative state defined as vasopressor requirement, mechanical circulatory support, dialysis, mechanical ventilation or cardiac arrest necessitating resuscitation.
* Patient with known condition that could interfere with portal flow assessment or interpretation (liver cirrhosis, portal vein thrombosis)
* Planned cardiac transplantation
* Planned ventricular assist device implantation