cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years.

To describe the immune response at 21 days following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.

Safety will be assessed throughout the trial period. Using antigens provided by Aventis Pasteur Inc., pre- and post-vaccination serum antibody titers for each of the three vaccine strains will be measured.

Eligibility Criteria:
Inclusion Criteria :

* Age of 18 years or greater.
* Ambulatory.
* In reasonably good health as assessed by the investigator.
* Available for duration of the study (21 days + 2d).
* Willing and able to meet protocol requirements.
* Willing and able to give informed consent.

Exclusion Criteria :

* Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
* An acute illness with or without fever (temperature \>100.4°F) in the 72 hours preceding enrollment in the trial.
* Clinically significant findings in vital signs (including temperature \>100.4°F) or review of systems.
* Self-reported history of severe adverse event to any influenza vaccine.
* Vaccination against influenza in the 6 months preceding enrollment in the study.
* Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
* Participation in any other experimental drug or vaccine trial within the 30 days preceding enrollment into the study.
* Immunosuppressive therapy including long-term (\> 2 weeks) systemic corticosteroids or cancer therapy within the past 3 months or ongoing.
* Receipt of blood or blood products within the 3 months preceding enrollment in the study.
* Diabetes
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine (e.g., existing severe chronic illness such as pulmonary disorders, cardiovascular disorders, chronic blood disorders, etc.).
* Person deprived of freedom by an administrative or court order (having legal or medical guardian).
* For women of childbearing age, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
Fatigue Reduction in Chronic Kidney Disease (CKD)

In this pilot trial, investigators will pilot test a cognitive behavioral intervention for acceptability and proof of concept for a larger future trial to be submitted for federal funding. This is a one-group design with qualitative and quantitative data collection integrated into the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Interest in participating in a fatigue study
* Age ≥18 years old
* Estimated glomerular filtration rate (eGFR) 15-44 mL/min/1.73 m2
* Ability and willingness to provide informed consent
* Ability to speak English
* Ability to walk
* Ability to join remote study sessions via WebEx

Exclusion Criteria:

* Current involvement in an activity/exercise program
* High likelihood of a kidney transplant within 6 months (assessed via the medical record)
* Any safety concerns about increased walking (assessed via the medical record)
The Olmsted NAFLD Epidemiology Study (TONES)

Researchers are assessing the prevalence of Non-alcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH) in the population and assembling a well-characterized cohort of adults with NAFLD and NASH to validate models of NAFLD diagnosis and determine long-term outcomes.

Non-Alcoholic Fatty Liver Disease (NAFLD) is the most common cause of chronic liver disease in the world and a major public health issue in the US. Recent information on the prevalence of NAFLD in general and Non-Alcoholic Steatohepatitis (NASH) with fibrosis in particular is very scarce. Such information is crucial for defining the epidemiology of NAFLD, identifying risk factors for advanced fibrosis and longitudinal outcomes. This study will enroll a random sample of adults from Olmsted County, Minnesota, to validate machine learning models for NAFLD diagnosis and disease severity. These data would be fundamental for the development of screening strategies in the community, which are urgently needed for early diagnosis of liver fibrosis and therapeutic interventions before cirrhosis develops.

Eligibility Criteria:
Inclusion Criteria:

* Olmsted County residents at the time of search
* Age 18 or older
* No personal history of NAFLD diagnosis (administrative codes)

Exclusion Criteria:

* Alcohol in excess (more than 20 gm per week in women and 30 gm per week in men)
* Currently pregnant
* Have contraindications to MRI (MRI incompatible implanted devices, severe claustrophobia)
Laser Therapy on Controlling Pain During Orthondontic Treatment

To evaluate the effectiveness of pain reduction on a initial orthodontic treatment by using 810nm Diode laser compared to a placebo. Methods: This study will include two parallels groups, 30 adult patients each (mean age 18 - 40) that will be asked to fill a questionnaire related with pain before starting orthodontic treatment with Tip edge technique. Patients from one of the groups will receive laser therapy on both upper and lower maxillary according to the protocol. The patients from the other group will receive a placebo simulating a laser therapy on both maxillary. After the process, both groups will be checked on different times (12hrs-24hrs-48hrs-72hrs after) by filling a questionnaire related with pain each time.

This is a parallel, double-blind, controlled, single-center clinical trial conducted in systemically healthy subjects requiring orthodontic treatment without extractions at the start of treatment in Bogotá, Colombia.

Sixty patients (60) will be randomized in a 1: 1 ratio, to either of the two arms of this trial.

This study will consist of a single visit by the patient, in this visit the assembly and activation of the upper and lower orthodontic appliances will be carried out.

Measurements of the primary outcome variable will be done remotely through a virtual pain monitoring questionnaire through a visual analog scale (Baseline, 12 hours, 24 hours, 48 hours, 72 hours).

After Screening a computer-generated scrambling code will be used for allocation in blocks of 6 to the two treatments.

The identity of included patients will not be provided to the trial team, in order to preserve the blinded aspect of the trial. The identity of the research treatment associated with each randomization number will be hidden from the trial team and patients. The final analysis is scheduled for when 100% of the patients (60 subjects) reach the 72-hour evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have signed and dated an informed consent form approved by the IRB in accordance with regulatory and institutional guidelines. This form must be obtained before performing any procedure related to the protocol that is not part of the subject's normal regimen.
* No need extractions
* No need Stripping

Exclusion Criteria:

* Periodontal disease
* Pregnant or lactance
* Medicated patients (analgesic, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers)
* Cardiac markpaser
Procalcitonin Test Reference Range Determination

Prospective, single-centre study in healthy volunteers to establish a reference range for the RAMP Procalcitonin (PCT) test. The primary objective of this study is to establish the reference range for measurement of PCT levels using the RAMP Procalcitonin test.

Healthy volunteers who meet eligibility criteria and have provided informed consent will be enrolled in this study. Each participant will be required to donate 1 blood sample via standard venipuncture into an EDTA (lavender top) tube for testing on one occasion. The maximum trial duration for each participant is one visit/occasion. Sample collection will take place within a single clinical session. The maximum trial duration for each participant is one clinic session.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy (as determined by a subject questionnaire) males or females, of any race
* \>18 years of age
* Willing to voluntarily agree to sign a consent form

Exclusion Criteria:

* Meets the definition for one or more of Systematic Inflammatory Response Syndrome (SIRS), Sepsis, Severe Sepsis, Septic Shock and/or Multiple Organ Dysfunction Syndrome (MODS) as defined by The American College of Chest Physicians (ACCP) and the Society of Critical Care Medicine (SCCM) consensus conference in 1992.
* Current diagnosis, or history, of any underlying major medical condition such as heart disease, hypertension/hypotension, stroke, renal disease, chronic obstructive pulmonary disorder, diabetes, bleeding disorders, hypercalcitoninemia, HIV, etc.
* Bacterial, fungal or malaria infection within previous 12 months
* Have experienced or undergone trauma, surgery, cardiac shock and/or a burn within previous 3 months
* Current diagnosis of cancer and/or has undergone Immunotherapy which stimulates cytokines in the previous 12 months
* Hospitalization (for \>24 hours) within previous 3 months
* Currently pregnant or nursing a child
* Unable, or unwilling, to provide required blood sample for testing
* Non-compliance to the protocol or inclusion criteria
* Investigator believes subject is unsuitable for inclusion in the trial (i.e. has major condition(s) or other reason(s) that could limit their ability to participate in the study; or impact the scientific integrity of the study)
Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer

The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.


Eligibility Criteria:
Inclusion Criteria:

* Non-metastatic primary invasive breast cancer overexpressing HER2 (determined by immunohistochemistry 3+ or positive fluorescence in situ hybridization test) that has been histologically confirmed, adequately excised, axillary node positive or negative, and tumor size at least T1c according to Tumor/Node/Metastasis (TNM) staging
* Completion of at least 4 cycles of (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable
* Known hormone receptor status
* Baseline left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55 percent (%)

Exclusion Criteria:

* Prior invasive breast carcinoma
* Other malignancies except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
* Clinical T4 tumors
* Cumulative doxorubicin exposure greater than (\>) 360 milligrams per meter-squared (mg/m\^2) or epirubicin \>720 mg/m\^2 or any prior anthracyclines unrelated to the present breast cancer
* Peripheral stem cell or bone marrow stem cell support
* Prior mediastinal irradiation except for internal mammary node irradiation for the present breast cancer
* Non-irradiated internal mammary nodes or supraclavicular lymph node involvement
* Prior anti-HER2 therapy for any other reason or other prior biologic or immunotherapy for breast cancer
* Concurrent anti-cancer treatment in another investigational trial
* Serious cardiac or pulmonary conditions/illness, or any other conditions that could interfere with planned treatment
* Poor hematologic, hepatic, or renal function
* Pregnancy or lactation
* Women of childbearing potential or less than 1 year post-menopause unwilling to use adequate contraceptive measures
Evaluation of Clinical Success of Restorations Using Different Magnification Aids

This study aimed to investigate the effect of using a loupe and dental operating microscope with different magnifications on the success of class II direct composite restorations.

A total of 130 class II, D2 deep caries teeth of 85 patients were randomly distributed to the naked eye, 3x magnification loupe, 5x magnification loupe, 8.5x magnification dental operating microscope (DOM) groups, and direct composite restorations were made with these magnification aids. carried out. Clearfil SE Bond 2 and Clearfil Majesty Posterior composite were used in all restorations. The restorations were evaluated using FDI criteria at 1,6 and 12-month periods, and restorations were scored between 1 and 5 for all criteria.

Eligibility Criteria:
Inclusion Criteria:

* Good oral and dental care of the patient,
* The need for at least 1 Class II restoration at a depth of D2 in the posterior group teeth,
* No crowding in the tooth to be restored, tooth contact and antagonist,
* The relevant tooth is vital,
* Absence of pain on percussion and palpation of the tooth.
* Absence of any pathology in the periapical tissues in radiographic evaluation,
* The patient was informed about the study and accepted the study,
* Having agreed to attend 1 month, 6 month and 12 month control sessions,
* The patient has no systemic disease,

Exclusion Criteria:

* Presence of severe periodontal disease,
* Teeth that cannot be insulated, malposed or overloaded or not loaded at all,
* Periodontal and endodontic removal of the relevant tooth is healthy,
* the patient is undergoing orthodontic treatment,
* Recording of dry mouth is set,
* Severe bruxism habit,
* Smoking
Sugammadex and Smoker's Neuromuscular Block

We compared the durations of antagonizing and of the severity of effect of sugammadex used in antagonizing the rocuronium in smoker and non-smoker total 40 patients with using Train of Four(TOF) neuromuscular monitorization.

40 patients from American Society of Anesthesiologist (ASA) I- II class, being smokers for at least 10 years or non-smokers, who will undergo elective surgery were included in this randomized prospective study. Patients underwent routine monitoring and neuromuscular monitoring. Propofol 2 mg/kg and intravenous fentanyl 1 mcg/kg were applied at induction. After the loss of eyelash reflex, intravenous rocuronium 0,6 mg/kg was administered. The patient was intubated at a Train of Four count of 2. Anesthesia was continued with 50% O2 + 50% air and sevoflurane 2 % . Rocuronium 0,15 mg/kg was administered when TOF (Train of Four) counter reached 2 during the operation. Sugammadex 2 mg/kg was administered at the end of the operation. The time to reach Train of Four values of 0,7-0,8-0,9 were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery,
* 1-2 according to the ASA ( American Society of Anesthesiologist ) physical status classification.
* Patients who have smoked at least 10 packs or have been smoking for 10 years and currently smoking
* Or never smoked patients

Exclusion Criteria:

* neuromuscular diseases
* radiotherapy and/or chemotherapy anamnesis,
* liver and/or renal disease,
* electrolyte balance,
* history of drug use which affects neuromuscular transmission,
* Body Mass Index (BMI) of more than 27,
* use alcohol
Effect of Probiotic Supplements on Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy

Background: Surgery can significantly improve the prognosis of patients with gastric cancer. However, some patients are at a later stage at diagnosis and need to receive neoadjuvant chemotherapy (NACT). Previous studies have shown that NACT may lead to more postoperative complications. Probiotics have the potential to reduce postoperative complications and infections, but no large sample, multicentre, randomized clinical trials have been conducted in patients with gastric cancer receiving NACT. The aim of this multicentre randomized controlled trial was to investigate the effect of probiotics on postoperative infections and other short-term outcomes in patients with gastric cancer receiving NACT.

Methods/design: This study is a prospective, multicentre RCT. This experiment will consist of two groups - an experimental group and a control group - randomly divided in a 1:1 ratio. The experimental group will receive perioperative probiotic supplement and that of the control group will receive blank control management. An estimated 318 patients will be enrolled. The main endpoint for comparison is postoperative infections between the two groups.The experimental group patients received probiotic capsules containing Bifidobacterium longum, Lactobacillus acidophilus, and Enterococcus faecalis.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* male and female
* clinical stage was T3/4N+ evaluated by CT/MR/EUS at new diagnosis (before any anti-cancer treatment) , complete 2-4 cycles preoperative chemotherapy based on 5-FU (such as SOX, FLOX, ect.) at 3-6 weeks before surgery
* ASA grade was Ⅰ\~Ⅲ
* radical minimal-invasive gastrectomy via laparoscope or DaVinci is judged as possible
* histologically confirmed gastric adenocarcinoma
* ECOG score is 0\~1
* patients who provide a written informed consent before entering study screening

Exclusion Criteria:

* need emergency surgery due to performation and/or obstruction
* receive antibiotics and/or glucocorticoids within 14 days before surgery
* exist bacterial infection and/or autoimmune disease and/or IBD currently
* intolerance or allergic to probiotics
* upper abdominal surgery history
* use probiotics within 7 days before intervention, such as yogurt, ect.
* participate in other clinical trials currently
* severe mental illness
* can not participate in this trial due to severe illness of other organs evaluated by researchers, such as severe cardiac insufficiency (LVEF\<30%, NYHA\>Ⅱ, severe arrhythmia, congestive heart failure, myocardial infarction within 6 months), liver dysfunction (Child-Pugh C), renal dysfunction (need hemodialysis)
* need simultaneous surgery
* lactation or pregnancy
* refuse to participate in this trial
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL

Retrospective multicenter study analyzing data gathered during the FUTURE study (S59342) to assess the effect of using Insulin Glargine 300 U/mL (Gla-300) on measures of diabetes control and quality of life.

Of the FUTURE participants, data about the type of insulin the participants used will be gathered. On the basis of these data participants will be divided in two groups (control or investigational).

Change in glycemic control and quality of life from before to after the switch to Gla-300 (investigational group) will be compared to the change of glycemic control and quality of life of the FUTURE participants who did not switch to Gla-300 (control group).

The FUTURE study was a 24-month during multicenter observational cohort study analyzing data on the use of the Abbott Freestyle Libre in people with diabetes. Data were gathered during standard clinical follow-up, and from questionnaires that were presented to the participants at defined time points.


Eligibility Criteria:
1. Investigational group

   Inclusion Criteria:
   * participant in the FUTURE study
   * diagnosed with type 1 diabetes ≥3 months before start of the FUTURE study
   * use of insulin pens for the entirety of the FUTURE study
   * used Insulin Detemir (Levemir®), Insulin Glargine 100 U/mL (Lantus®) or an equivalent as basal insulin before switch to Gla-300 (Toujeo®)
   * switched to Gla-300 (Toujeo®) during the FUTURE study for a sufficient amount of time (at least two consecutive diabetes consultations = 8 months)

   Exclusion Criteria:
   * use of Fast-acting insulin aspart (Fiasp®) before or after switch to Gla-300
   * not using bolus insulin (only basal insulin)
   * for women: pregnant or planning pregnancy during the FUTURE study
2. Control group

Inclusion Criteria:

* participant in the FUTURE study for at least 18 months
* diagnosed with type 1 diabetes ≥3 months before start of the FUTURE study
* use of insulin pens for the entirety of the FUTURE study
* use Insulin Detemir (Levemir®), Insulin Glargine 100 U/mL (Lantus®) or an equivalent as basal insulin during the entirety of the FUTURE study

Exclusion Criteria:

* use of Fast-acting insulin aspart (Fiasp®)
* not using bolus insulin (only basal insulin)
* for women: pregnant or planning pregnancy during the FUTURE study
* switch to Gla-300 (Toujeo®) or Insulin Degludec (Tresiba®) before 18 months in FUTURE study (if switched after 18 months, only data up to switch to Gla-300 \[Toujeo®\] or Insulin Degludec \[Tresiba®\] will be used for this control participant)
Furlong Evolution® Hip Trial

Total hip replacement (THR) is a highly effective procedure in relieving pain and restoring function. Many different implants can be used in artificial hip joints. Hydroxyapatiteceramic (HAC) coating has become a well established The JRI Furlong® HAC femoral stem is one such implant with good long term survivorship. The femoral implant has been used since 1985 and published findings have shown a 97.4% survivorship at a mean of 17 years follow up in patients. The Furlong Evolution® design is based on the tried and tested Furlong HAC but with some modifications.

This is a 10 year multicentre clinical surveillance study, which aims to assess the clinical, functional and radiological performance of the Furlong Evolution® Hip stem in human patients.

Purpose and Design:

The Furlong Evolution® design is based on the tried and tested Furlong H.A.C implant but with some modifications. It still retains its full H.A.C coating and is much shorter in length. This potentially makes it easier to introduce into the femoral canal, which may result in less soft tissue damage and lower rate of femoral fracture. This would be very beneficial, should revision (implant replacement) be required at a later date. This potential characteristic has been highlighted as an important component of determining the clinical effectiveness of a total hip replacement.

As per the National Institute of Clinical Excellence (NICE) guidelines the best prostheses demonstrates a revision rate (the rate at which they need to be replaced) of 10% or less at 10 years. This should be regarded as the current benchmark in the selection of prostheses for primary Total Hip Replacement (THR). It is also considered reasonable to recommend a prostheses with a maximum of 3% revision rate at 3 years which would indicate performance would then be subjected to annual review (up to 10 years) to ensure that the revision rate remains consistent with the 10year benchmark. The Orthopaedic Data Evaluation Panel (ODEP) was established to evaluate data on the outcomes of prostheses provided by manufactures and to inform the NHS which products are compliant with the benchmarks set by NICE. Therefore this study will be a ODEP compliant multicentre prospective surveillance study of the Furlong Evolution® Hip Stem that will assess the clinical, functional and radiographical performance over a 10 year period in compliance with the NICE guidelines.

Eligibility Criteria:
Inclusion Criteria:

1. All patients consenting to total hip replacement
2. All patients deemed suitable for total hip replacement
3. All patients passing pre-assessment deeming them medically fit enough for total hip replacement.

Exclusion Criteria:

1. Patients deemed unsuitable for Total Hip Replacement
2. Patients who refuse to have surgery opting for other modes of treatment
3. Patients who are unable to consent due to a lack of capacity
4. Patients unable to understand English
5. Any patient under the age of 18 years.
6. Patients who are pregnant or breast feeding