cyrilzakka/clinical-trials huggingface dataset:
Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients

The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.

This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with EGFR-mutation，primary endpoint is progress-free survival，second endpoints include overall survival, time to progression, and so on.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
* Positive EGFR Mutation.
* No previous systemic anticancer therapy.
* Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
* Provision of written informed consent.

Exclusion Criteria:

* Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
* Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
* Known severe hypersensitivity to icotinib or any of the excipients of this product.
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
Enhancing Food as Medicine Interventions for Food Insecure Postpartum Women in Central Texas

The purpose of this study is to compare the short-term and long term impacts of Food is the Best Medicine (FBM)-Virtual on diet quality, food security status, breastfeeding rates, mental health status, rates of home cooking, and rationing coping strategies relative to FBM-In Person among food insecure, postpartum women and to compare implementation outcomes across the FBM-Virtual and FBM-In Person using process data collected from the participants, Community Health Worker (CHW)s, and partner organizations.


Eligibility Criteria:
Inclusion Criteria:

* food insecure
* to communicate in English or Spanish.

Exclusion Criteria:

* not living within the food produce zip code delivery radius
* having any dietary allergies.
A Trial of Multi-convergent Therapy for Functional Symptoms and Stress in Patients With Inflammatory Bowel Disease

The purpose of this study is to determine whether multi-convergent therapy is helpful to patients with inflammatory bowel disease who have functional abdominal symptoms or high perceived levels of psychological stress.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Inflammatory Bowel Disease
* Clinical Remission of inflammatory bowel disease as defined by an adapted disease activity index and a CRP \<10
* Age 18 to 65 years
* Evidence of irritable bowel syndrome (Rome III criteria) or high perceived stress level (Levenstein perceived stress score \> 0.44)

Exclusion Criteria:

* Use of steroids within 1 month of entry to study
* Initiation or change in dose of medication within 1 month of entry to the study
* Presence of ileostomy or colostomy
* Diagnosis of dementia or cognitive impairment
* Current psychosis or substance misuse
* Change in psychotropic medication in 3 months prior to entry to study
* Previous psychological interventions
* Pregnancy
A New Scoring System for Perineural and Vascular Invasion in Pancreatic Cancer

The aim of this study is to validate both retrospectively and prospectively a newly proposed scoring system for perineural and vascular invasion in pancreatic ductal cancer and correlate it with disease free survival, early recurrence, site of recurrence, overall survival and neoadjuvant treatment.

Perineural invasion (PNI) is defined as the presence of cancer cells along nerves and/or within the epineural, perineural and endoneural spaces of the neuronal sheath.Clinically, PNI is associated with increased tumor recurrence, poor survival after pancreatectomy and pain, an invalidating symptom that may impair quality of life. Pancreatic ductal adenocarcinoma has one of the highest incidences of PNI (70-100%) among all types of cancer, which correlates with a poor prognosis and decreased survival. PNI is a still not uniformly characterized or quantified event, usually it is described only dichotomously ("present" or "absent"), despite some efforts to use a more detailed scoring system. However, these scores are not specifically developed for pancreatic surgical specimen. Vascular invasion (VI), which is assumed to be associated with a more aggressive tumor biology and dissemination, lacks a specific scoring system as well. The primary aim of this study is to validate both retrospectively and prospectively a novel PNI and VI scoring system aimed at a more detailed stratification of perineural invasion, together with an accompanying scoring system for vascular invasion, and correlated them with disease free survival (DFS).

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Patients undergoing all types of pancreatic resection (pancreatoduodenectomy, left pancreatectomy, total pancreatectomy, both laparotomic and laparoscopic).
* Proven pancreatic ductal adenocarcinoma (cytology or biopsy).
* Patients that received neoadjuvant therapy (CT +/- RT) can be included.
* Patients able to sign the informed consent.

Exclusion Criteria:

* Age \< 18 years.
* Patients with other ongoing oncological diseases.
Graves' Disease Remission Study: MycoMeth Combo

A randomized study to evaluate the efficacy and safety of combining mycophenolate mofetil with methimazole in patients with newly diagnosed Graves' disease.

The remission rate of methimazole standard therapy in patients with newly diagnosed Graves' disease is only around 50%. Main reason for the low remission rate is methimazole therapy is not a drug targeting etiology of Graves' disease. The investigators hypothesize that adding mycophenolate mofetil, an immunosuppressor, to methimazole standard therapy will improve remission rate. The study will evaluate the efficacy and safety of combining mycophenolate mofetil with methimazole in patients with newly diagnosed Graves' disease. 205 eligible patients will be randomized to mycophenolate mofetil combined with methimazole therapy or methimazole standard therapy. The primary outcome is the remission rate at 12 months.

Eligibility Criteria:
Inclusion Criteria:

- 1. aged 18 to 60 years.

2. Patients newly diagnosed with Graves' disease.

Exclusion Criteria:

* 1. Patients with Graves' disease who have undergone treatment or experienced relapse.

  2. Hyperthyroidism due to other etiologies (toxic multinodular goiter, toxic thyroid adenoma, Hashimoto's thyroiditis, subacute thyroiditis, iodine-induced hyperthyroidism, etc.).

  3. Individuals requiring intervention for moderate to severe thyroid eye disease at the time of enrollment.

  4. Patients with hyperthyroidism requiring surgery due to concurrent thyroid cancer.

  5. Those with severe liver or kidney dysfunction (ALT or AST \> 3 times the upper limit of normal reference values, blood creatinine \> 135 mol/L for males, and 110 mol/L for females).

  6. Individuals with leukopenia (WBC \< 3.0×109/L).

  7. Patients with severe heart failure (NYHA class III or IV).

  8. Individuals with chronic or severe infections such as pulmonary tuberculosis, hepatitis B, etc.

  9. Pregnant women, breastfeeding women, those planning pregnancy in the near future, or individuals who cannot comply with contraception during trial.

  10. Participants in or previously involved in other clinical studies.

  11. Individuals unwilling or unable to comply with follow-up or unwilling to participate.
Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste)

The purpose of this study is to determine if abuse liability indices will be impacted by varying flavors and e-cigarette (ECIG) nicotine delivery capability (i.e., nicotine flux) among current combustible cigarette users.

The investigators will compare abuse liability indices between three FDA-authorized ECIG products that vary in nicotine flux (but are all tobacco flavor) and own brand cigarettes. The investigators will also test the influence of ECIG flavor availability (tobacco vs. menthol) within three ECIG product classes.


Eligibility Criteria:
Inclusion Criteria:

* healthy (determined by self-report)
* at least 18 years old
* willing to provide informed consent
* able to attend the lab and use designated products according to study protocol
* smoke cigarettes at least 3 days per week and on those days at least 1 cigarette smoked per day
* positive urine cotinine test

Exclusion Criteria:

* Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
* Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
Methimazole in Graves' Disease - Comparing the Computer-aided Treatment DigiThy Versus Usual Care

The goal of this clinical trial is to compare two methods of guiding methimazole therapy in patients with Graves' disease: methimazole dose adjustments based on a new semi-automated computer-guided treatment (based on a mathematical model) or based on the treating physician's decision (i.e. usual care). The main question it aims to answer is whether semi-automated computer-guided treatment is not inferior to usual care in terms of safety, the time it takes to achieve euthyroidism and the methimazole dose required.


Eligibility Criteria:
Inclusion Criteria:

* Active Graves' hyperthyroidism \[Thyroid-stimulating hormone \<0.1 mU/L, elevated free thyroxine levels (fT4) above the upper limit of normal and positive Thyrotropin receptor antibody (TRAb) according to local laboratory results\], measured within the last month prior to the inclusion date
* Patients not yet receiving antithyroid treatment, or having received antithyroid treatment continuously for less than 4 weeks, or relapse or recurrence of Graves' hyperthyroidism defined as patients previously having received and discontinued treatment with antithyroid drugs for at least 4 weeks)
* Age 18 years or older
* Provision of written informed consent

Exclusion Criteria:

* Previous treatment with radioactive iodine
* Ongoing antithyroid treatment for more than one month
* Pregnancy
* Treatment with propylthiouracil
Safety and Immunogenicity Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old

This study evaluates the safety and immunogenicity of the ACYW135 Meningococcal Polysaccharide Vaccine in population aged 2-50 years old. Subjects will be divided into 3 group according to their age, receiving the test vaccine and the control vaccine at the proportion of 1:1 randomly. Each age group has 400 subjects, 1200 in total.


Eligibility Criteria:
Inclusion Criteria:

* With the subject (or his guardian's) informed consent and signed the informed consent;
* The history, physical examination and clinical judgement were determined to be healthy and in accordance with the vaccination age of the product;
* The Subject or his guardian could comply with the clinical study protocol;
* Have not been inoculated with Meningococcal vaccine in the past six months and A + C meningococcal polysaccharide vaccine in the past two years;
* Have not been inoculated with other preventive biological products;
* Axillary temperature≤37.0 ℃.

Exclusion Criteria:

* Children with the history of Neisseria meningitis;
* Had allergies or serious adverse reactions of previous vaccination, such as allergies, urticaria, dyspnea, edema, abdominal pain, etc;
* Had immune inhibitor therapy and cytotoxic therapy, inhaled corticosteroids in the past 6 months (not including allergic rhinitis corticosteroid aerosol therapy, patients with acute non concurrent dermatitis surface corticosteroid therapy);
* Have been accepted blood products in the past 3 months;
* Have been inoculated with other research drugs or vaccines in the past month;
* Have been inoculated with attenuated live vaccine in the past 14 days;
* Have been inoculated with subunit or inactivated vaccine in the past 7 days;
* Had any acute illness, the need for systemic application of antibiotics or antiviral treatment in the past 7 days;
* Had fever in the past 3 days (axillary temperature≥38.0℃) ;
* Have been diagnosed with abnormal coagulation function (such as the lack of coagulation factors, coagulation disorders and abnormal blood platelet), obvious bruises or coagulation disorders by physician diagnosis;
* Had the history of thyroid resection or the need for treatment of thyroid diseases in the past 12 months;
* Asplenia, functional asplenia and asplenia or splenectomy of any situation;
* Had epilepsy, convulsions, encephalopathy, mental illness or family history;
* Suffering from serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia, neurological disorders or Guillain-Barre syndrome);
* Suffering from known or suspected concurrent diseases including: respiratory diseases, acute or chronic infection of the activities, children's mother or the subject had HIV infection, cardiovascular disease, high blood pressure, during cancer treatment period, skin diseases;
* The female during her pregnant and lactation period or who plan to become pregnant during the trial.
* The subject of any other factors that are not suitable to participate in clinical trials according to the researcher's judgment.
Observation of Principal Hemodynamic Variables After Spinal Anesthesia With Non Invasive Hemodynamic Monitoring

The study is aimed at observe how spinal anesthesia modifies the hemodynamic state of the patient after optimization to preload independence with a Goal Directed Therapy algorithm guided by non invasive hemodynamic monitoring with Clearsight.

This is an observational prospective single group study.

Patients will be monitored with ECG (III leads), non invasive blood pressure cuff (NIBP) cuff, pulse oximetry and Clearsight finger cuff after their arrival in the operating room. Basal Stroke Volume (SV) and indexed Stroke Volume (SVI) will be registered.

The basal value will be optimized according to the study goal directed fluid therapy algorithm: a 200ml fluid challenge will be administered until the SV will increase of at least 10%. When the SV will stop increasing significantly after crystalloid administration, the SV and SVI value will be registered as SVoptimized (SVopt) and SVI optimized (SVIopt), while the same values trigger of the last fluid challenge will be registered as SVtarget1 and SVItarget1. A constant infusion of crystalloids 2 ml/Kg/h will be maintained throughout the study period.

Then, spinal anesthesia will be administered (levobupivacaine 0.5% 0.25mg/kg of ideal weight) in lateral decubitus. After 15 minutes, patients will be turned supine and after 5 minutes SV and SVI will be registered and compared with values SVtarget1 and SVItarget1: if within 10% of range, data will be registered as SVtarget2 and SVItarget2 and patient will maintain basal crystalloid infusion. Otherwise, patients will receive a fluid optimization similar to what described previously before spinal, until values will be within 10% of range of SV and SVI.

Afterwards patients will be transferred to the operating room and will be followed as described in Figure 2. At the end of surgery, patients will be transferred to the Recovery Room and will be monitored and optimized.

When patients will reach an Aldrete's Score ≥ 9/10 and a Bromage's score = 0 with sensibility restored at S1, we will compare SV and SVI value with SVtarget1 and SVItarget1 and treated accordingly.

Spontaneous micturition will be tested and in case a bladder volume \> 600ml will be detected with ultrasound before recovery room discharge criteria fulfillment, we will proceed with urinary catheterization.

At patient discharge from the Recovery Room the study will be completed.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective primary hip arthroplasty
* scheduled for spinal anesthesia
* American Society of Anaesthesiologists' (ASA) score 2 or 3
* aged between 50 and 80 years

Exclusion Criteria:

* contraindications to neuraxial anaesthesia
* peripheral vascular abnormalities
* American Society of Anaesthesiologists' (ASA) score 1, 4 and 5
* patients' refusal
Mucosal Immunity in Terms of SARS-CoV-2 Antibodies in Saliva After COVID-19 Infection and Vaccination

The Primary Objective of This Single-center Study is to Investigate the SARS-CoV-2 Spike Glycoprotein RBD Antibody Concentration in Saliva and Serum in Healthy Non Vaccinated and Non-SARS-CoV-2 Infected, COVID-19 Convalescents, Persons Vaccinated With Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1 nCov-19 AZD1222 Vaccines, and Convalescent COVID-19 Patients That Have Subsequently Been Vaccinated. A Potential Difference in the Immunoglobulin Concentrations of the Pfizer-BioNTech BNT162b2 Vaccine, Moderna mRNA-1273 vaccine and the AstraZeneca ChAdOx1-S Vaccine Will be Uncovered. This Knowledge About the Mucosal Immunity Will be Important for Further Designing of Vaccine Strategies.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Both Hospital staff as well as non-health care workers will be invited to participate

Exclusion Criteria:

* Individuals not fulfilling the inclusion criteria or declining blood or saliva collection.
* Exclusion criteria are neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using Salivette.
A Feasibility Study of Early Mobilisation Programmes in Critical Care

The objective of this study is to determine the feasibility of delivering a very early mobility rehabilitation program in Intensive Care Units (ICU), within the context of a randomised controlled trial (RCT). This will inform the design of a future RCT investigating very early ICU rehabilitation in the UK National Health Service.

Early ICU-based physical rehabilitation may benefit patients with acute severe respiratory failure by attenuating the development of severe and persistent weakness and impaired physical function seen in these patients.

Muscle wasting occurs early (within 12 hours) and progresses rapidly after ICU admission. Patients may suffer from consequent physical impairment for months or years following their discharge.

ICU based rehabilitation has the potential to improve physical function outcomes, through mitigating muscle wasting.

The investigators have successfully introduced a very early ICU mobility program in their institution, which results in increased ventilator free days and reduced length of ICU stay.

The primary aim is to investigate whether this method will work in other ICUs. EMPRESS will test the feasibility of running this intervention as an RCT. The results and a concurrent process evaluation will inform the design of a future, multi-centre randomised controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Acute/unplanned medical admissions to the ICU.
* \> 42 years old.
* Functionally independent prior to ICU admission (Barthel \>80).
* In hospital for \<5 days prior to intubation and ventilation.
* Intubated and ventilated for \<72 hrs.
* Expected to remain ventilated for a further 48 hours.

Exclusion Criteria:

* In hospital for 5 days or more prior to ITU admission.
* Patients with acute brain or spinal cord injury.
* Known or suspected neurological / muscular impairment.
* Condition limiting use of cycle ergometer e.g. lower limb fracture / amputation.
* Not expected to survive \>48hrs.
* Persistent therapy exemptions in first 3 days of mechanical ventilation.
* Body habitus such as unable to use cycle ergometer.
* Consultant clinician view that patient not suitable or not expected to survive admission.
Efficacy and Safety of Basic Triple Therapy Including Ilaprazole on the First Line Eradication Treatment of H.Pylori

This study compared efficacy and safety of basic triple therapy including Ilaprazole 10mg, Levofloxacin 500mg and Amoxicillin 1000mg BID for 10 days on the first line eradication treatment of H.pylori

This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori.

Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test. For 10 days, Participants treated as basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang Amoxicillin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.
* Subject who fully understands conditions of clinical trial.
* Subject who agrees to participate and spontaneously sign the ICF

Exclusion Criteria:

* Known hypersensitivity to any component of ilaprazole, Amoxicillin and Levofloxacin
* Subjects who are taking contraindicated medications for experimental and concomitant drug.
* Patients with abnormal levels in the laboratory tests

  * Total Bilirubin, Creatinine\> 1.5 times upper limit of normal
  * AST, ALT, Alkaline phosphatase, BUN\> 2 times upper limit of normal
* Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study.
* Pregnant and/or lactating women
* Reproductive aged women not using contraception
* Uncontrolled diabetics
* Uncontrolled hypertension
* Uncontrolled liver dysfunction
* Alcoholics
* Subjects with a history of digestive malignancy within 5 years
* Subjects with a history of gastrectomy or esophagectomy
* Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption.
* Subjects participating in a clinical trial before another trial wihin 30 days
* Inconsistence judged subject by researcher
Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.

To establish the effects of genotropin replacement in patients with severe growth hormone deficiency after traumatic brain injury on cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* Have had a previous traumatic brain injury (more than 1 year and less than 5 years) prior to the screening visit.
* Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5.

Exclusion Criteria:

* Active systemic malignancy or active intracranial tumor. A successfully treated tumor or malignancy is not an exclusion criterion if the patient has not had active disease for 5 years and is not currently receiving maintenance chemotherapy, (except for basal cell skin cancers.
* Receiving treatment with prednisolone in doses above 10 mg/day or treatment with other oral glucocorticosteroids above replacement doses is not permitted throughout the study. Topical and inhaled corticosteroids are permitted.