cyrilzakka/clinical-trials huggingface dataset:
A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects

To evaluate, in healthy adult volunteers, the safety and immunogenicity of multivalent HIV-1 peptide immunogen, a formulation of HIV-1 gp120 principal neutralizing domain (PND) branched synthetic peptides from 15 viral strains representative of diverse worldwide isolates.

Because there is considerable variation among HIV-1 virus strains from differing geographical locations worldwide, a multivalent peptide vaccine has been constructed to include prevalent and divergent isolates, potentially providing for wide coverage of geographically isolated epidemics.

Because there is considerable variation among HIV-1 virus strains from differing geographical locations worldwide, a multivalent peptide vaccine has been constructed to include prevalent and divergent isolates, potentially providing for wide coverage of geographically isolated epidemics.

Fourteen volunteers are entered at one of two dose levels of multivalent candidate vaccine. At each dose level, 12 volunteers receive vaccine and two receive placebo. At least eight volunteers at the low dose level must be monitored for 2 weeks before subsequent volunteers are entered at the high dose. Intramuscular injections are given on days 0, 28, and 168, and patients are followed for a minimum of 48 weeks after the initial immunization. Approximately 13 clinical visits are required.

Eligibility Criteria:
Inclusion Criteria

Subjects must have:

* Normal history and physical exam.
* HIV negativity by ELISA within 8 weeks of immunization.
* CD4 count \>= 400 cells/mm3.
* Normal urinalysis.

Exclusion Criteria

Co-existing Condition:

Subjects with the following symptoms or conditions are excluded:

* Positive hepatitis B surface antigen.
* Medical or psychiatric condition or occupational responsibilities that preclude study compliance.
* Active syphilis. NOTE: Subjects whose serology is documented to be a false positive or due to a remote (\> 6 months) treated infection are eligible.
* Active tuberculosis. NOTE: Subjects with a positive PPD and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.

Subjects with the following prior conditions are excluded:

* History of immunodeficiency, chronic illness, or autoimmune disease.
* History of anaphylaxis or other serious reactions to vaccines.

Prior Medication:

Excluded:

* History of immunosuppressive medications.
* Live attenuated vaccines within 60 days prior to study entry (NOTE: Medically indicated subunit or killed vaccines, e.g., influenza or pneumococcal, are not exclusionary, but should not be given within 2 weeks of HIV immunization).
* Experimental agents within 30 days prior to study entry.
* Prior HIV vaccines.

Prior Treatment:

Excluded:

* Blood products or immunoglobulin within the past 6 months.

Identifiable higher risk behavior for HIV infection, including the following:

* History of injection drug use within the past 12 months.
* Higher risk sexual behavior as defined by the AVEG.
Feasibility of Dignity Therapy Intervention on Cancer Patients in Charge to an Hospital Palliative Care Unit.

Aim of the study was to asses feasibility and acceptability of a nurse delivered Dignity Therapy (DT) intervention on advanced cancer patients referring to an Hospital palliative care unit. To achieve this aim a mixed-method approach using before and after evaluation and semi-structured interviews has been used.


Eligibility Criteria:
Inclusion Criteria:

* advanced cancer patients
* over 3 months life expectancy
* referring to hospital palliative care unit
* performance status (Eastern Cooperative Oncology Group - ECOG) between 0 and 2
* awareness of being affected by an incurable cancer
* cognitive ability to read, understand and fill in a questionnaire in Italian
* willing and able to give written informed consent

Exclusion Criteria:

* \< 18 years old
Shear Wave Elastography for Carotid Atherosclerotic Plaques

The goal of this prospective diagnostic accuracy cohort study is to compare the accuracy of carotid atherosclerotic plaques stiffness assessed by shear wave elastography (SWE) with greyscale median values (GSM), magnetic resonance imaging (MRI) and histopathological findings in patients with carotid atherosclerotic plaques causing stenosis above 50%, symptomatic or not.

The main question it aims to answer is: is the plaque stiffness correlatable with GSM values, MRI findings or histopathological findings? Participants will be subjected to a vascular ultrasound study in which the SWE and GSM will be assessed. The second imaging modality for stenosis confirmation will be MRI and patients with confirmed symptomatic stenosis above 50% or assymptomatic stenosis above 70% will be considered for surgery intervention (endarterectomy or angioplasty). Patients that undergo endarterectomy will have the carotid plaques subjected to a histopathological study. The study will not arbitrate about the treatment decision.


Eligibility Criteria:
Inclusion Criteria:

* Patients with atherosclerotic carotid plaques that develop stenosis superior to 50%.

Exclusion Criteria:

* Previous cervical surgery;
* Previous cervical radiotherapy;
* Stenosis caused by vascular inflammatory diseases;
* Pregnant women;
* High carotid bifurcation (inaccessible by vascular ultrasound linear probe);
* Posterior acoustic shadowing that impair morphological evaluation of the plaque.
An Observational Study Evaluating the Safety of Topiramate for the Prevention of Migraine

A 6-month, observational, post authorization safety study for the collection and evaluation of additional safety data on topiramate as a prophylactic treatment for migraines in adult patients. According to current European and international guidelines the safety and efficacy of drugs will be continuously monitored even after their approval and market circulation.The applicable methods of monitoring include: Observational studies, voluntarily reported adverse events, clinical trials of IV phase and Post Authorization Safety Studies ( PASS). Post Authorization Safety Studies (PASS) during the use of a product are a significant source of information regarding the action of the drug or a therapeutic method under the circumstances of every day clinical practice.

Previous studies have shown that topiramate is effective in preventing migraine headaches. This is a 6-month observational study to evaluate additional safety data of topiramate in the prevention of migraine in adult patients. The study duration is 6-months, with 5 study visits during the study. Administration of topiramate should be according to current Summary of Product Characteristics (SmPC) and daily clinical practice. The decision to prescribe topiramate is decided by the Health Care Professional and it is independent of the protocol. Based on the investigator's judgement, patients who enter the study should fulfill the criteria for administration of prophylactic treatment. In this study a total number of 80 patients with diagnosed migraine according to the criteria of the International Headache Society HIS (Cephalalgia 1998; 8 (Suppl7) :1-98) will participate. Patients who will be enrolled should be either male or female over 18 years of age, fulfilling the above mentioned criteria and who will agree to sign the written informed consent for the anonymous and confidential use of their medical data with their participation in the study. Methods of evaluation include tolerability, laboratory tests, vital signs and Body Weight and Body Mass Index (BMI). Efficacy by assessing migraine attacks, symptomatic medications and Headache Impact Test (HIT-6). Observational study - No investigational drug administered.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the IHS (International Headache Society) diagnostic criteria for migraine
* Patients who satisfy the migraine prophylactic medication criteria

Exclusion Criteria:

* Ineligible patient according to the marketed Summary of Product Characteristics of topiramate
* Patient with hypersensitivity to topiramate or to some of its components
Lactobacillus Bifidobacterium V9(Kex02)Improving the Efficacy of Carilizumab Combined With Platinum in Non-small Cell Lung Cancer Patients

Human microbes have been called "the second genome of humanity".On May 13,2016,the White House launched the National Microbiome Initiative (NMI), with an estimated investment of us $521 million, to elevate microbiome research to a national strategic status. The gut is the largest microecological environment in the human body. The research in the field of intestinal microbiome has become one of the most advanced and hot research directions in the scientific field of the world today. At present, more than 50 diseases have been found to be related to intestinal microbiome disorders. Pd-1 (programmed death receptor 1) is an important immunosuppressive molecule.It regulates the immune system and promotes tolerance by down-regulating the immune system's response to human cells and by suppressing T cell inflammatory activity. In the past, the research team and colleagues in related fields have found a strong correlation between Gut Microbiome and the efficacy of anti-PD-1 immunotherapy in cancer patients.This protects against autoimmune diseases, but it also prevents the immune system from killing cancer cells. As more and more scientific evidence shows that intervention of human intestinal flora may improve the efficacy of anti-PD-1 immunotherapy in tumor patients, intestinal flora, as the most effective way to intervene human intestinal flora, has been mentioned by many research institutions and international drug manufacturers in combination with anti-PD-1.Our previous study showed that the abundance of beneficial bacteria such as lactic acid bacteria, bifidobacteria and Akkermansia Muciniphila was significantly correlated with pD-1 inhibitor response, and regulating the intestinal flora content could improve the effect of PD-1 inhibitor on mouse tumors, indicating that microbial flora was involved in regulating cancer immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Karnofsky score ≥90 in patients receiving immunotherapy for non-small cell lung cancer at our cancer center

Exclusion Criteria:

* any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease or drug allergy to V9
Post-Acute Physician Home Visit Program

New or worsening symptoms following discharge from the hospital likely leads to unplanned readmission. These rates are higher than desired and costly to patients, payers, and providers. Many interventions have unsuccessfully attempted to reduce readmissions, but few have provided in-home personnel to patients transitioning from acute care back to ambulatory care. Still fewer have involved a physician in the home. We therefore will test the effect of a physician home visit to a patient's home who was discharged in the last 4 days.


Eligibility Criteria:
Inclusion Criteria:

* Resides within either a 5-mile or 20-minute driving radius of Brigham and Women's Hospital (BWH) or Brigham and Women's Faulkner Hospital (BWFH) emergency room
* Has capacity to consent to study
* \>=18 years old

Exclusion Criteria:

* Undomiciled
* In police custody
* Domestic violence screen positive
Time Restricted EATing (TREAT) Pilot Study

The TREAT Pilot is a 3 months open-label pilot study to examine the effect of restricting the duration of eating (Time Restricted EATing) in metabolically unhealthy adults with overweight or obesity. This pilot study will allow the investigator to collect preliminary data for the design of a larger study.

Disruption of the circadian rhythm, caused by aging, obesity, shift work, or prolonged daily eating duration into hours normally reserved for sleep, is a recognized risk factor for impaired metabolism and cardiovascular disease risk. Mice with disrupted clock gene have dysmetabolism. Restricting the eating window in these mice improves their metabolism.

Data will be collected to examine the feasibility and effect of a lifestyle intervention, aiming to reduce body weight in metabolically unhealthy individuals with overweight and obesity. The TREAT pilot study employs the use of mobile application to document eating behavior, when, what and how much people eat. In addition, the participants will receive reminders and complete in-person study visits to monitor their eating and sleeping schedule.

Eligibility Criteria:
Inclusion Criteria:

* age: 45-73y old
* overweight or obesity with BMI ≥25.0 and ≤35.0 kg/m2
* pre-diabetes or diabetes only diet controlled (HbA1c \<7%)
* elevated Blood Pressure (BP) 120-129/\<80 mmHg or stage 1 high BP 130-139/80-89 mmHg, with clinical Atherosclerotic Cardiovascular Disease (ASCVD) or estimated 10-y Cardiovascular Disease (CVD) risk \<10%
* having LDL cholesterol \<150mg/dl
* no known sleep, psychiatric or food intake disorders
* in possession of a smart phone
* English-speaking
* must live in New York city geographical area and not have planned travel schedule interfering with the study

Exclusion Criteria:

* history or clinical evidence of condition that affect sleep
* significant organ system dysfunction/disease: diabetes, severe pulmonary, kidney or cardiovascular disease, and any evidence of active illness (e.g., fever)
* history of seizure disorder
* being on medications for diabetes, hypertension or dyslipidemia
* previous bariatric surgery
* history or current significant psychiatric disorder
* use dietary supplements and/or medications known to affect sleep, circadian rhythms or metabolic function
* smoking tobacco or using illegal or recreational drugs
* consume excessive alcohol (women: \>14 drinks/wk; men: \>21 drinks/wk)
* consume large amounts of caffeine daily (\>2 cups of coffee or 8 oz caffeinated drinks per day)
* participate in intense exercise (causing heavy breathing and sweating, such as jogging) \>2 d/wk for ≥35 min or moderate exercise (e.g., brisk walking) for \>150 min/wk
* shift work
* extreme early and late chronotypes
* unwilling/unable to provide informed consent
Addressing Inequity in Dermatology

The objectives of this study are to understand the variation in dermatoses presenting in individuals from different ancestry backgrounds. This will be conducted at multiple NHS hospitals in England. The Investigators specifically aim to 1) assess features of dermatoses in individuals of different ancestry. 2) Understand the language used by patients describing their condition.


Eligibility Criteria:
Inclusion Criteria:

* Dermatologist diagnosed disease, with visible active dermatological disease

Exclusion Criteria:

* No dermatological disease, no active pathology identifiable, aged 18 and above but lacks capacity to consent.
miRNA-155 Assay Before and After Immunotherapy and Probiotics

The investigators aimed to explore miRNA-155 change in response to sublingual immunotherapy (SLIT), probiotics and combined treatment with SLIT and probiotics in AR children.

Allergic rhinitis (AR) is an inflammatory state characterized by a disturbance of immunoregulatory mechanisms that leads to an amplified T helper "Th-2" response. Micro-RNAs (miRNAs) are short single-stranded RNA molecules that post transcriptionally control gene expression and can mediate allergic process. The aim of this study was to explore miRNA-155 change in response to sublingual immunotherapy (SLIT), probiotics and combined treatment with SLIT and probiotics in AR children.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-18 years
* Diagnosed as having AR
* With positive skin test to grass pollen

Exclusion Criteria:

* Anatomical abnormalities of upper respiratory tract,
* Previous immunotherapy,
* Clinically significant inﬂammatory diseases,
* Malignancies,
* Chronic treatment with systemic corticosteroids or immune suppressive drugs
Prevalence of Keratoconus in Inflammatory Bowel Diseases

A retrospective study has shown the association between the inflammatory bowel diseases (IBD) and the presence of a keratoconus. This new study will measure the prevalence of keratoconus and follow its activity in patients affected by IBD and followed up in hepatology-gastroenterology department at Nancy Hospital. The prevalence of keratoconus will be compared to known data of literature about general population.

The secondary purpose is to search for a relationship between the presence of a keratoconus and activity criteria of IBD.

Perspectives are a systematic screening for keratoconus in patients affected by IBD with the amelioration of the ophthalmologic care of IBD patients and confirmation of the recent hypothesis of inflammatory origin of keratoconus.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Affiliation to social security plan
* Diagnosis of IBD since more than 3 years, under treatment or not

Exclusion Criteria:

* Protected person
* Pregnant or breastfeeding women
* Person in life-and-death emergency
* Person deprived of liberty
* Refusal to remove contact lenses, where necessary
Apatinib in the Treatment of Metastatic Colorectal Cancer

This is an Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic Colorectal Cancer Who Have Progressed after Standard Second Line Therapy.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 and ≤ 80 years of age
* Histological confirmed advanced or metastatic colorectal cancer，at least one measurable lesion, larger than 10 mm in diameter by spiral CT
* Have failed for ≥ 2 lines of chemotherapy and/or targeted therapy
* Life expectancy of more than 3 months
* ECOG performance scale 0～1
* Duration from the last therapy is more than 4 weeks for operation, radiotherapy or cytotoxic agents
* Adequate hepatic, renal, heart, and hematologic functions (platelets \> 80 ×10\^9/L, neutrophil \> 1.5 × 10\^9/L, serum creatinine ≤ 1×upper limit of normal(ULN), bilirubin \< 1.5 ULN, and serum transaminase ≤ 2.0× ULN)
* Child bearing potential, a negative urine or serum pregnancy test result before initiating apatinib, must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article.
* Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

* Prior VEGFR inhibitor treatment within 2 weeks
* History of other malignancies within 5 years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy
* More than class I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia(including QTcF:male ≥ 450 ms, female ≥ 470 ms), or cardiac insufficiency myocardial ischemia, arrhythmia, or cardiac insufficiency
* Pregnant or lactating women
* Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* URT: urine protein ≥ (++)and \> 1.0 g of 24 h
* PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation
* Certain possibility of gastric or intestine hemorrhage
Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD


Eligibility Criteria:
Key Inclusion Criteria:

* Signed written informed consent
* 40 - 80 years of age
* Clinical history of COPD with airflow limitation that is not fully reversible
* Females of non-child bearing potential or females of child bearing potential with negative pregnancy test and acceptable contraceptive methods
* Current/former smokers with at least a 10 pack-year history of cigarette smoking
* A measured post-bronchodilator FEV1/FVC ratio of \< or = 0.70
* A measured post-bronchodilator FEV1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values
* Able to change COPD treatment as required by protocol

Key Exclusion Criteria:

* Women who are pregnant or lactating
* Primary diagnosis of asthma
* Alpha-1 antitrypsin deficiency as the cause of COPD
* Active pulmonary diseases
* Prior lung volume reduction surgery
* Abnormal chest X-ray not due to the presence of COPD
* Hospitalized due to poorly controlled COPD within 3 months of Screening
* Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
* Cancer that has not been in complete remission for at least 5 years
* Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives

Other inclusion/exclusion criteria as defined in the protocol
Accuracy of Measurement of Surface Body Temperature Using the Health e Pod Device (Card Guard) Compared to Gold Standard Equipment

Objective To evaluate the accuracy of data acquisition by Health e pod device in measurement of body temperature, to compare it to a standard body temperature measure equipment About 400 consecutive patients admitted to PEU in Assaf Harofeh Medical Center will compile the Study Population.

Basic vital signs will be recorded on admission and during hospitalization as per the PEU policy and not in particular for this study.

As a part of routine check-up all admitted patients undergo body temperature measure (oral or rectal - as per the PEU policy and with PEU devices).

Following an explanation and patient agreement, eligible patients (and their legal guardian) will sign informed consent and enter the study. The health e pod device will be applied to measure body temperature, immediately after the standard temperature measure has been performed by the PEU professional.


Eligibility Criteria:
Inclusion Criteria:

* Signed an Informed Consent by the patients' legal custodian / guardian (and assent by the patient when applicable).
* Age 0 to 18 years
* Clinically stable patients hospitalized in PEU.

Exclusion Criteria:

* Implanted pacemaker or defibrillator.
* Patients participating in other clinical trail.