cyrilzakka/clinical-trials huggingface dataset:
Cross-reactive Immunity Elicited by Oral and Parenteral Typhoid Vaccines

In a recent controlled study, the investigators explored cross-reactive immune responses against different Salmonella spp. in healthy volunteers immunized with either the oral (Vivotif® ) or parenteral (Typherix®) typhoid vaccines (ISRCTN68125331). In the present study immune responses will be studied in a group receiving both of these vaccines and in the previously immunized volunteers after booster immunization (same groups receive same vaccines 2-4 years after primary immunization).

Many Salmonella spp causing gastroenteritis share O antigen serotypes with Salmonella enteritidis subsp. enterica serovar Typhi (S.typhi) and could therefore be in 'reach' of the protective efficacy of the oral live typhoid fever vaccine Vivotif®. Some of these Salmonellae are common causes of diarrhoea in travellers (0-30% of travellers diarrhea depending on the area). In a recent controlled study, the investigators showed that a cross-reactive immune response is elicited against different Salmonella spp. in healthy volunteers immunized with either the oral (Vivotif® ) or parenteral (Typherix®) typhoid vaccines (ISRCTN68125331).

In the present study immune responses will be studied in a group receiving both of these vaccines and in previously immunized volunteers after booster immunization (same groups receive same vaccines 2-4 years after primary immunization; groups: Vivotif / Typherix / Vivotif + Typherix). The results are compared to those obtained after primary immunization.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥18 to ≤65 years
2. General good health as established by medical history and physical examination
3. Written informed consent
4. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable.
5. Available for all visits scheduled in this study.

Exclusion Criteria:

1. Primary groups: Vaccination against typhoid fever within 5 years before dosing.
2. History of clinical typhoid fever, clinical paratyphoid A or B fever.
3. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study
4. Current intake of antibiotics or end of antibiotic therapy \<8 days before first IMP administration
5. Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational vaccine; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed
6. Acute or chronic clinically significant gastrointestinal disease
Experiment 2: Understanding Liver Fat Metabolism

There is a largely unsubstantiated thought in the literature that dietary unsaturated enter oxidation pathways preferentially compared to saturated fatty acids. This study is undertaking a direct comparison of the oxidation of dietary saturated and unsaturated fatty acids.

Provided subjects meet the inclusion criteria, then at least one week after the screening visit volunteers will then undertake the first two 'study days'. There will be two study days on separate occasions that will be up to 3 weeks apart. Each study day will be approximately 7 hours in duration. On each study day participants will be given a standardised 'test' meal that contains specially labelled fat molecules (stable-isotope tracer) and then repeated breath and blood samples will be taken over the course of the next 6 hours. The test meal consumed on each 'study day' will be identical in composition with only the specially labelled fat molecules being different (either unsaturated or saturated fat) and these will be given in a random order.

Eligibility Criteria:
Inclusion Criteria:

Participant is willing and able to give informed consent for participation in the study.

Male or Female, aged \>18 and \<65 years BMI \>19 \<35kg/m2 No medical condition or relevant drug therapy known to affect liver metabolism

Exclusion Criteria:

* • Age \<18 or \>65 years

  * Body mass index \<19 or \>35kg/m2
  * A blood haemoglobin \<120mg/dL
  * Any metabolic condition or relevant drug therapy
  * Smoking
  * History of alcoholism or a greater than recommended alcohol intake
  * Pregnant or nursing mothers
  * Women prescribed hormone replacement therapy (HRT) or who have used this within the last 12 months
  * History of severe claustrophobia
  * Presence of metallic implants, pacemaker
  * Haemorrhagic disorders
  * Anticoagulant treatment
everlinQ Endovascular Access Systems Enhancements (EASE-2) Study

Prospective, single-center study to evaluate the everlinQ endoAVF System when used to create an endoAVF in hemodialysis patients. This study aims to investigate expansion of the percutaneous venous access location to the superficial system which may provide additional procedural benefit.

A total of up to 50 subjects will be enrolled and will undergo an endoAVF creation procedure using the everlinQ System. All subjects may be followed for up to 12 months post index procedure based on Investigator's discretion. The duration of the study is expected to be approximately two (2) years.

Eligibility Criteria:
Inclusion Criteria:

1. Eligible for a native arteriovenous fistula.
2. Adult (age \>18 years old).
3. Established, non-reversible kidney failure requiring hemodialysis (including pre-dialysis patients).
4. Target vein diameter(s) at fistula site ≥ 2.0 mm.
5. Target artery diameter at fistula site ≥ 2.0 mm.
6. Procedural access site artery and vein diameter ≥ 2.0 mm.
7. At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the perforating vein.
8. Estimated life expectancy \> 1 year.
9. Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure.
10. Presence of an antecubital perforating vein diameter ≥ 2.0 mm.

Exclusion Criteria:

1. Known central venous stenosis or central vein narrowing \> 50% based on imaging on the same side as the planned AVF creation.
2. Upper extremity venous occlusion(s) and/or vessel abnormality(ies) on the same side as the planned AVF creation that precludes endovascular AVF creation by the everlinQ System as deemed by the interventionalists' clinical judgment.
3. Prior surgically created access in the planned treatment location.
4. Functioning surgical access in the planned treatment arm.
5. Pregnant women.
6. New York Heart Association (NYHA) class III or IV heart failure.
7. Hypercoagulable state.
8. Known bleeding diathesis.
9. Immunosuppression, defined as use of immunosuppressive medications used to treat an active condition.
10. Documented history of drug abuse including intravenous drugs within six months of AVF creation.
11. "Planned" concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment.
12. Currently being treated with another investigational device or drug.
13. Known allergy to contrast dye which cannot be adequately pre-medicated.
14. Known adverse effects to sedation and/or anesthesia which cannot be adequately pre- medicated.
15. Patients who do not have an ulnar or radial artery.
16. Distance between target artery and vein or other anatomical abnormality will not permit catheters to be introduced, navigated to fistula site, or allow magnets to align vessels sufficiently to create the fistula.
17. Evidence of calcification in vessels at the fistula site.
18. Evidence of active infections on the day of the index procedure.
19. Written informed consent not obtained.
Phytoserms for Menopause Symptoms and Age-Associated Memory Decline

The purpose of this study is to evaluate the safety and efficacy of a soy based dietary supplement (phytoSERM) for hot flashes and age associated memory loss.


Eligibility Criteria:
Inclusion Criteria:

* post-menopausal women
* ages 45 - 60 (inclusive)
* must have a vasomotor symptom (e.g., hot flash) and a memory complaint

Exclusion Criteria:

* history of clinically significant stroke
* current evidence or history in past 2 years of epilepsy, seizure, focal brain lesion, head injury with loss of consciousness or any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
* Known allergy to soy derived products; hypersensitivity to estrogens or progestins
Investigation of Chronic Obstructive Pulmonary Disease (COPD) Phenotypes and Endotypes in China

This is a non-drug interventional cohort study, which aims to investigate the clinical, radiological and biological factors associated with disease progression in COPD in China. Participants will be recruited from multiple hospitals across Guangdong province categorized as Type A hospitals (those at prefecture-level and above) and Type B hospitals (those below prefecture-level).


Eligibility Criteria:
Inclusion criteria:

* Male or female participants, aged 50-80 years inclusive. A female is eligible only if she is of non-child bearing potential.
* Body mass index (BMI) less than (\<)35.
* A signed and dated written informed consent is obtained prior to participation.

Additional inclusion criteria for COPD participants:

* A Baseline (post-bronchodilator) (FEV1/FVC) ratio \<70 percent (%).
* Clinically stable and has no exacerbations for at least 1 month prior to recruitment.
* Ever smoker or never smoker.

Additional inclusion criteria for chronic bronchitis participants:

* Free from other significant diseases.
* Baseline post-bronchodilator FEV1/FVC ratio more than (\>)70%.
* Chronic bronchitis is defined as at least 3 months of cough and phlegm in a year in the past 2 years.
* Clinically stable and has no exacerbations for at least 1 month prior to recruitment.
* Ever smoker or never smoker

Additional inclusion criteria for healthy participants:

* Free from any significant diseases
* Baseline post-bronchodilator FEV1/FVC ratio \>70%.
* A CAT score \<10.
* Never smoker. Passive smoker is not eligible.

Exclusion criteria:

* Having undergone lung surgery.
* Known respiratory disorders or significant inflammatory disease other than COPD.
* Serious, uncontrolled disease (including serious psychological disorders)
* Confirmed cancer, unless participants in remission for more than or equal to (\>=)5 years.
* Participating or plan to participant in any clinical studies where investigational drugs were tested.
* Unable or unwilling to use required digital devices (sub- cohort only).
* Have evidence of alcohol or drug abuse.
* Have received a blood transfusion in the 4 weeks prior to study start.
* On long-term oral corticosteroids.
* Unable to walk.
* Unable to read and understand Mandarin Chinese.

Additional exclusion criteria for COPD participants:

* Current primary diagnosis of asthma (participants with a primary diagnosis of COPD but who also had asthma \[Asthma COPD overlap {ACO}\] could be included).
* Known disorders other than COPD that may significantly impact clinical assessments

Additional exclusion criteria for chronic bronchitis participants and healthy participants:

* Known disorders that may significantly impact clinical assessments.
* FVC \<80% Predicted.
Effect of Barbed Suture and Triclosan-coated Monofilament in Emergency Surgery

Patients will be randomized 3 groups:

Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed Polydioxanone suture

Group 2:Abdominal fascial closure will be performed with Triclosan-coated monofilament Polydioxanone suture

Group 3: Abdominal fascial closure will be performed with monofilament Polydioxanone suture

Incisional surgical.site infection and evisceration will be recorded.

Patients will be randomized 3 groups:

Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed Polydioxanone suture (Stratafix Symmetric, J\&J), caliber 1, 48mm-cylindric needle.

Group 2:Abdominal fascial closure will be performed with Triclosan-coated Polydioxanone loop suture (PDS plus looc, J\&J), caliber 1, 48mm-cylindric needle.

Group 3: Abdominal fascial closure will be performed with Polydioxanone loop suture (PDS plus looc, J\&J), caliber 1, 48mm-cylindric needle.

Incisional surgical.site infection and evisceration will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Contaminated and Dirty surgery
* Emergency surgery performed by midline laparotomic approach
* The following diagnosis will be included:

  * Anastomotic leak of previous digestive surgery (colon, small bowel or gastric surgery)
  * Colonic or bowel perforations
  * Appendicitis with purulent of fecal peritonitis, undergoing midline laparotomy
  * Perforation of gastric or duodenal ulcer
  * Intestinal ischemia requiring bowel resection

Exclusion Criteria:

* Emergency surgery undergoing laparoscopic approach
* Appendicitis operated by McBurney incision
* Intestinal isquemia without requiring bowel resection
Thromboelastography During and After Delivery

The purpose of this study is to establish reference values for thromboelastography (TEM-A) in healthy pregnant women during labor and 2 hours and 24 hours after delivery.

Previous, preliminary investigations by using thromboelastography, confirmed that pregnancy is a hypercoaguable state which remains in the first 24 hours postdelivery. Unfortunately results obtained by the existing studies that attempted to establish reference values for TEG suffer considerable bias.

The aim of this study will be to determine the range values for thomboelastography in pregnant women. Since there is no available information on the expected distribution of the outcome, a sequential design will be used. The main endpoint of the analysis will be a reliable estimate for the outcome expected in healthy women after labor. The investigators will state their target estimate as being reliable when the ratio between the estimate and its standard error is smaller than 2.

During labor, 2 hours after delivery and 24 hours postpartum, a venous blood sample will be taken from eligible women for thromboelastographic determination. Whole blood nonadditive TEM will be performed on the TEM-A automated thromboelastometer (Framar Biomedica,Rome, Italy) to obtain the four classical TEM parameters: reaction (R) time, k time, alpha angle and maximum amplitude (MA).

Inclusion criteria Healthy parturients in labor Exclusion criteria parturients who will eventually had: operative or instrumental vaginal delivery, estimated blood loss greater than 500 mL, the occurrence of II and III degree perineal lacerations, any coagulation disorder or anticoagulant therapy

Eligibility Criteria:
Inclusion Criteria:

* healthy parturients in labor

Exclusion Criteria:

* parturients with coagulation defects or anticoagulant therapy
Acute Effects of Beet Juice Intake on the Vascular Function of Hypertensive Patients

To assess the acute effects of only one dose of beet juice on hypertensive subjects treated with vascular endothelial function parameters, using the microvascular reactivity method.

Systemic arterial hypertension is an established risk factor for cardiovascular disease (CVD). Among the main modifiable environmental factors of hypertension, the investigators highlight inadequate eating habits, such as low vegetable consumption. Clinical studies have shown that inorganic nitrate from beet juice intake has a protective effect against CVD due to reduced blood pressure, inhibition of platelet aggregation and prevention of endothelial dysfunction. However, there is still no consensus on its benefits of inorganic nitrate in vascular health. Associated with this, there are no previous studies in the literature that correlate the acute effects of inorganic nitrate intake on endothelial function assessed by microvascular reactivity through laser. The objective of the present study is to evaluate the acute effects (single dose) of inorganic nitrate, through the ingestion of beet juice, in the vascular parameters and endothelial function of treated hypertensive patients of both sexes.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes
* Age between 40 and 70 years
* Previous diagnosis of primary systemic arterial hypertension
* Signed the Informed Consent Term.

Exclusion Criteria:

* Secondary hypertension
* Systolic blood pressure greater than or equal to 180 mmHg or diastolic BP greater than or equal to 110 mmHg
* In use of beta-blockers
* Diabetes mellitus
* History of cancer
* Use of any dietary supplement
* Any serious life-threatening illness
* Cardiovascular diseases
Safe Passages: Ensuring Quality Transitions From NICU (Neonatal Intensive Care Unit) to Ambulatory Care

Infants born prematurely or with complex congenital abnormalities are surviving to discharge in growing numbers and often require significant monitoring and coordination of care in the ambulatory setting. The specific aims of this project are to determine the effectiveness of a redesigned discharge process that includes a Health Coach and an expanded discharge binder to improve health outcomes in the post discharge follow-up period as compared with usual care. The outcomes to be evaluated include the occurrence of adverse events in the post-discharge period, quality of follow up care, and caregiver satisfaction with the process.

Infants born prematurely or with complex congenital abnormalities are surviving to discharge in growing numbers and often require significant monitoring and coordination of care in the ambulatory setting. These complicated infants have spent all of their lives in the hospital setting, and are strangers in their own homes. Although the transition of the fragile child from intensive care specialist to the ambulatory care provider begins at hospital discharge, it is incomplete until the child receives appropriate outpatient follow-up with a primary care pediatrician. Over this prolonged time period, the child is especially vulnerable to errors related to breakdowns in care coordination and communication because the responsibility for the patient's care is often not clearly specified. Our team of investigators has recently completed a Health Care Failure Modes and Effects Analysis (HFMEA) of the transition from neonatal intensive care to the ambulatory environment. We will expand upon the Care Transitions Intervention developed by Coleman et al that addressed the problems of older adults who were discharged from hospital to home. In this model, advanced practice nurses, trained as coaches, taught patients and families to coordinate care for themselves, fostering independence. We will include the use of a personal health record, to include specific instructions to recognize and self-manage the most common problems in this population and we will use information technology (IT) to enhance communication with families and with community providers, in particular the primary care provider. Having identified that lack of knowledge and skills on the part of community providers about how to manage these infants as an important risk point, we will add to the Coleman intervention by providing "just-in-time" information to the primary care providers to enhance their knowledge and skill in managing the common problems of neonatal nursery graduates, provided electronically via the Texas Children's Hospital (TCH) clinical decision support program.

Eligibility Criteria:
Inclusion Criteria:

* Infant hospitalized since birth
* Anticipated total length of stay at least 2 weeks
* Speaks English or Spanish
* Planned follow up physician within the hospital's system

Exclusion Criteria

* follow up physician outside of hospital system
* child in protective custody
* child not anticipated to survive
Registry for Advanced Sarcodiosis

Registry with evaluation and genetic information of patients with advanced sarcoidosis and matched sarcoidosis


Eligibility Criteria:
Inclusion criteria

* Patients with diagnosis of sarcoidosis based on ATS/WASOG criteria 22
* Age ≥ 18 years.
* Life expectancy of at least 2 years.
* Pulmonary function tests (spirometry) within one month of entry or willing to under pulmonary function testing on the day of study enrollment
* Sarcoidosis as characterized as either advanced or non-advanced (see protocol for definition of advanced disease)
* Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.

Exclusion criteria

* Subjects with a medical disorder, condition, or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator
* Inability to comply with the protocol and/or not willing or not available for follow-up assessments.
* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
Enhancing HIV Prevention by Using Behavioral Intervention Among HIV-Infected Men

This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management in promoting safer sex practices in HIV-infected men.

In recent years, the spread of HIV and other STDs has increased, especially among men who have sex with men. This increase signifies continued sexual risk taking within this population. In order to curb the increase of HIV infections, prevention programs are needed. A standard prevention case management program has been developed; however, new programs that further improve outcomes are needed. This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management (PCM) in promoting safer sex practices in HIV-infected men.

Participants in this 1-year open-label study will be randomly assigned to receive either PCM alone or a behavioral intervention called Project Enhance, in addition to PCM. The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. PCM will entail standard case management, as well as referrals to specific services that each individual may need. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* Receives primary health care at Fenway Community Health
* Identifies as a man who has sex with men
* Has engaged in unprotected anal or vaginal intercourse within 3 months of study enrollment

Exclusion Criteria:

* All episodes of unprotected anal intercourse occurred with only a single primary partner who is also HIV infected
* Plans to relocate over the upcoming year
The Clinical Study of Assessing HER-2 Expression in Gastric Cancer With Extra Tumor Tissue Paraffin Blocks Using Immunohistochemistry

Background: Gastric cancer (GC) is major global health concern and the second leading cause of cancer deaths worldwide. Amplification of Her2/neu gene and/or overexpression of the Her2/neu protein have been observed in GC. Trastuzumab (Herceptin™) is an anti-Her2/neu antibody, which has been successfully applied in GC. However, the intratumoral heterogeneity of Her2/neu overexpression and amplification in GC should be noticed. The investigators investigated the significance of evaluating Her2/neu expression in different paraffin blocks of tumor tissue in GC.

Methods: 2000 GC patients from ten centers, patients were divided into a cohort using one tumor tissue paraffin block (cohort 1, n=1000) and a cohort using dual tumor tissue paraffin blocks (cohort 2, n=1000) when evaluating Her2/neu expression status by immunohistochemistry (IHC). In cohort 2, the investigators combined the results from two different paraffin blocks and used the higher one as the final score.


Eligibility Criteria:
Inclusion Criteria:

* Undergone curative surgery of gastric cancer,
* 18-80 years old.

Exclusion Criteria:

* None