cyrilzakka/clinical-trials huggingface dataset:
Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine in Children Previously Vaccinated in Trial V118_05 (NCT01964989)

Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously vaccinated in Trial V118_05. Subjects will receive either the Same or Alternate Type of Vaccine.


Eligibility Criteria:
Inclusion Criteria:

In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.

* Subject's parent/legal guardian has voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
* Male or female subject who has completed their Visit 13 (Study Day 366 for non-naïve subjects) or clinic Visit 15 (Day 390 for naïve subjects) in parent trial V118_05.
* For naïve subjects in parent trial V118_05 to have received two doses of the same study vaccine (i.e. 2 doses of aQIV or 2 doses of QIV).

Exclusion Criteria:

* Previous immunization with any influenza vaccine (licensed or investigational) within 6 months prior to enrollment.
* Subjects with a clinical condition representing a contraindication to intramuscular vaccination or blood draws.
* Unwillingness of the parent(s)/ legal guardian(s) of the subject to refuse to participate in another clinical trial while enrolled in V118-05E3.

Additional eligibility criteria may be discussed by contacting the site.
Deliberate Ultraviolet Light Exposure to Get a Tan by Young Adult Sexual Minority Males

The purpose of this study is to: a) identify enablers and barriers to deliberate ultraviolet light exposure by young sexual minority men (SMM), and b) quantify the extent of their deliberate ultraviolet light exposure.

Aim 1: To develop survey items to assess tanning attitudes and behaviors Nine survey items used by the PI in previous deliberate tanning research were adapted with the expert consensus of members of Northwestern's Institute for Sexual and Gender Minority Health and Wellbeing. Discussions with the PI, research personnel and members of the institute developed the hypothesis that in addition to the previously reported appearance motivations young SMM may be engaging in tanning (indoors or outdoors) as a social activity. A tenth survey item was developed to assess deliberate tanning as a social activity.

Aim 2: Analyze the tanning attitudes and behavior data acquired in an online survey of young adult sexual minority males, who regularly participate in the RADAR study.

RADAR is a longitudinal study with cohorts from the greater Chicago region recruited between 2008 and 2015. The 10 survey items about tanning attitudes and behaviors were added to the online survey that examines SMMs' behavior in the prior 6 months. This is a secondary analysis of registry data acquired by the RADAR study.

Eligibility Criteria:
Inclusion Criteria:

* Young adult SMM (age 18-39)
* Able to read English
* Have internet access
* Willing to complete the online survey

Exclusion Criteria:

* None
Innovative Stratification of Arrhythmic Risk (ISAR-Trial): Eldery

The objective of this study was to determine the prognostic utility of established risk predictors following acute ST elevation myocardial infarction in patients over 75 years of age.


Eligibility Criteria:
Inclusion Criteria:

acute myocardial infarction; aged \>75 years

Exclusion Criteria:

-
Impacts of Different ART Regimens on Lipid Metabolism in People Living With HIV

To compare the dynamic changes of lipid metabolism of people living HIV who treated with different antiretroviral therapy (ART) regimens such as Biktarvy EVG/c/TAF/FTC, DTG/FTC/TDF, TDF/3TC/EFV, etc. And to assess the safety and efficacy of different antiretroviral therapy.

This was a prospective observational study aiming to evaluate dynamic changes of lipid metabolism in people living HIV who treated with different antiretroviral therapy (ART) regimens. At the same time, cardiovascular risk and the incidence of non-alcoholic fatty liver disease are assessed so as to compare the effects of different regimen on cardiovascular risk and NAFLD and hope to discover several cardiovascular risk-related individual lipid species.

Eligibility Criteria:
Inclusion Criteria:

1. People with HIV aged 18 years and older
2. Treated with stable antiretroviral therapy
3. Plasma HIV-1 RNA below 50 copies per milliliter for at least six months
4. Without other comorbidities or concomitant medications
5. Good compliance and can cooperated with the follow-up
6. Willing to participate in the study and sign informed consent.

Exclusion Criteria:

1. Pregnant or breast-feeding
2. Patients with poor treatment compliance
3. Patients refused to attend the regular follow-up examination
4. Patients with severe cardiovascular and cerebrovascular diseases or liver and kidney dysfunction
5. Acute infection (malaria, tuberculosis, helminthiasis, pneumonia, meningitis), moderate or severe malnutrition and diarrhea in the last 3 months
6. Take medications that may interfere with lipid metabolism throughout the study, such as statins/fibrates, antidiabetic
7. Participated in other clinical trials within 3 months.
8. Patients with severe mental illness
Characterising Arm Recovery in People With Severe Stroke

The main goal of this program of research is to advance our understanding of how the severely damaged brain changes over the first 12-months post stroke. The investigators will determine 'who recovers', 'who does not recover', and 'why'

The main goal of this program of research is to advance our understanding of how the severely damaged brain changes over the first 12-months post stroke. The prevalence and severity of stroke related arm disability is increasing and the prospect of optimal recovery is poor. Studies have demonstrated that stroke survivors with severe disability lack early indicators (\<7-days to \<1-month post-stroke) of a good prognosis, such as active movement at the shoulder and wrist and integrity of the corticospinal tract. This has propagated the clinical belief that this cohort are unlikely to functionally benefit from rehabilitation efforts. However, it is possible that indicators of potential for recovery - either neuroanatomical or clinical - may present in individuals with severe stroke later, that is beyond the early time-period. Indeed, there is increasing evidence of the potential for ongoing improvements in motor performance in response to intensive interventions that are undertaken 6-months or more post-stroke. This therefore, implies that there is some degree of untapped recovery potential. However, as very few studies have longitudinally explored the potential indicators of recovery in a severe cohort, the dynamic capacity of the severely damaged remains unknown. Thus, there is a need to determine 'who recovers', 'who does not recover', and 'why' to be able to promote optimal arm recovery in people with severe impairment after stroke. We will assess stroke survivors \<4-weeks, 3-months, 6-months and 12-months post stroke using a range of neuroimaging and clinical outcome measures. The findings from this study will build the foundations for more personalized health care options for people with severe arm impairment post stroke.

Eligibility Criteria:
Inclusion Criteria:

* adults aged 18 to 90 years;
* sustained their first stroke;
* demonstrate subacute (\<1 month) and severe upper limb motor deficits (defined by a SAFE \[shoulder abduction and finger extension\] score of \<5 out of 10 points); and
* can follow single stage commands

Exclusion Criteria:

* neurological condition other than stroke e.g., Parkinson's disease
A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.

A clinical trial to study the efficacy and safety of an investigational drug in people with major depressive episodes associated with with Bipolar I disorder (bipolar I depression) Participants in the study will either receive the drug being studied or a placebo. The study will be conducted in approximately 90 sites in North America, Europe, Latin America and Japan. It will be have both male and female participants ages 18-65. Participation in the study will be approximately 10 weeks.

This study is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of treatment with SEP-4199 CR at fixed doses of 200 mg/day or 400 mg/day compared with placebo for the treatment of major depressive episode associated with bipolar I disorder (bipolar I depression). The study is projected to randomize approximately 522 subjects inNorth America, Japan, Europe and Latin America, to SEP-4199 CR 200 mg/day, SEP-4199 CR 400 mg/day, and placebo treatment groups in a 1:1:1 ratio

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria (not all inclusive):

* Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
* Subject is 18 to 65 years of age, inclusive, at the time of informed consent.
* Subject meets DSM-5 criteria, based on the SCID-5-CT, for bipolar I disorder, current episode depressed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance but \< 8 episodes in the previous 12 months) with or without psychotic features.
* Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration at Screening.
* Subject has a MADRS total score ≥ 22 at both Screening and Baseline.
* Subject has a CGI-BP-S depression score ≥ 4 at both Screening and Baseline.
* Subject has a YMRS total score ≤ 12 at both Screening and Baseline.
* Subject is in good physical health, based on medical history, physical examination, neurological examination, vital signs, ECGs, and results of clinical laboratory tests (hematology, chemistry, and urinalysis).

Exclusion Criteria:

Exclusion Criteria (not all inclusive):

* Subject currently has any DSM-5 defined psychiatric diagnosis other than bipolar I disorder that was the primary focus of treatment, or is currently being treated with concomitant medication
* Subject has a lifetime history of, or symptoms consistent with, schizophrenia, schizoaffective disorder, or a major psychiatric diagnosis other than bipolar I disorder that is judged to pose risk to the study scientific objectives
* Subject has a history of non-response to an adequate (6-week) trial of 3 or more antidepressants (with or without mood stabilizers) during the current major depressive episode.
* Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that would pose a risk to the subject or that might confound the results of the study.
Impact of Myfortic on Gastrointestinal (GI) Prophylaxis in Maintenance Renal Transplant Patients

The purpose of this study is to determine whether maintenance renal transplant patients receiving Myfortic can reduce or discontinue GI prophylaxis medications.

GI prophylaxis is common post kidney transplant and is routinely used in patients receiving a variety of different immunosuppressive regimens. Cellcept and prednisone are often the biggest concern for GI distress and GI ulcers. Routine use of GI prophylaxis medications post-transplant are potentially one mental obstacle to transplant clinicians being fully persuaded of the GI neutral effect of myfortic in the immunosuppressive regimen. Patients receiving myfortic (as part of the conversion in the US02 study) are theoretically at a reduced risk for GI upset and development of GI ulcers. These patients are ideal candidates to discontinue their GI prophylaxis medications while taking myfortic.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed the parent study, US02.
* Patients on GI medications.
* Patients currently receiving Myfortic (all dosages are allowed), neoral or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least two weeks.
* Patients with and/or without mild GI complaints (e.g. upper abdominal pain, dyspepsia, anorexia, nausea, vomiting) with or without diarrhea.
* Females of childbearing potential must have a negative pregnancy test prior to the inclusion period. The test should be performed at Baseline visit. If positive, the patient will not be included. Effective contraception must be used during the trial, and for 4 weeks following discontinuation of the study medication.
* Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

Exclusion Criteria:

* Evidence of graft rejection or treatment of acute rejection within 14 days prior to Baseline visit.
* Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry.
* Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
* Patients with thrombocytopenia (\<75,000/mm3), with an absolute neutrophil count of \<1,500/mm3 and/or leukocytopenia (\<4,000/mm3), and/or hemoglobin \<9.0g/dL prior to enrollment.
* Presence of clinically significant infection requiring continued therapy, severe diarrhea or active peptic ulcer disease that would interfere with the appropriate conduct of the study.
* Evidence of severe liver disease (incl. abnormal liver profile i.e. AST, ALT or total bilirubin \>or= 3 times ULN).
* Abnormal physical or laboratory findings of clinical significance within 2 weeks of inclusion which would interfere with the objectives of the study.
* Evidence of drug and/or alcohol abuse.
* Inability to self-administer the GSRS, GIQLI and PGWBI questionnaires.
* Patients receiving \>10mg/day prednisone dose.
Mesothelin and Osteopontin as Diagnostic Markers in Patients With Mesothelioma or Atypical Mesothelial Hyperplasia

RATIONALE: Studying levels of mesothelin and osteopontin in samples of blood from patients with mesothelioma or atypical mesothelial hyperplasia may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at mesothelin and osteopontin as diagnostic markers in patients with mesothelioma or atypical hyperplasia.

OBJECTIVES:

Primary

* Determine if mesothelin and osteopontin in serum can serve as early markers of malignant transformation into mesothelioma.

Secondary

* Determine if there are cytological, histological, immunohistochemical, and molecular markers of precancerous disease in tissue samples.
* Determine if SV40 has a carcinogenic role.
* Determine the relationship between the serum concentration of mesothelin and/or osteopontin and the expression of other markers and with clinical progression.

OUTLINE: This is a multicenter study.

Levels of mesothelin and osteopontin in serum (and pleural fluid, if effusion is present) are measured at baseline and 3, 6, 12, and 24 months. Patients with mesothelioma, reactional lesions, or adenocarcinoma undergo tomodensitometry (TDM) at baseline, 3, 6, and 12 months. Patients with pleural plaques only undergo TDM at 12 months.

Patients are followed for 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Inclusion criteria:

* Diagnosis of mesothelial hyperplasia and meeting 1 of the following criteria:

  * Confirmed prior exposure to asbestos and presence of pleural effusion and meets 1 of the following diagnostic criteria:

    * Mesothelioma
    * Mesothelial hyperplasia of unspecified malignancy
    * Reactional inflammatory hyperplasia
  * No asbestos exposure but pleural effusion with pleural malignant mesothelioma or pulmonary metastasis
  * Prior exposure to asbestos, no pleural effusion, and asymptomatic (pleural plaques present)
  * No prior exposure to asbestos but with benign pleural effusion
* Tissue obtained by pleuroscopy, surgical biopsy, or video-thoracoscopy available

  * Paraffin-embedded and frozen tissue available

Exclusion criteria:

* Solitary fibrous tumor
* Diffuse pleural fibrosis
* Purulent pleurisy

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or radiotherapy
Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers

This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), in healthy male and female adult volunteers. Safety of E004 will also be evaluated, under augmented dose conditions.

This study is a randomized, evaluator-blind, single dose, three-arm, crossover, PK study, to be conducted in \~18 healthy, male and female, adult volunteers. PK will be studied at two dose strengths (Arm T1 and Arm T2). A currently marketed, non-labeled, Epinephrine CFC-MDI will be used as a Reference Control (Arm C).

* At the Screening Visit and the beginning of each Study Visit, each subject will be trained on the correct self-administration of MDI. The following three randomized treatments will be self-administered, at three Study Visits:

  * Treatment T1: Ten (10) inhalations of the low dose E004(125 mcg/inhalation), totaling 1.25 mg of epinephrine;
  * Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine;
  * Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation, totaling 2.2 mg of epinephrine base equivalent).
* PK blood samples will be taken from a vein at scheduled time points.
* Safety parameters and adverse drug events, if any, will be monitored and documented at each study visit. An End-of-Study (EOS) safety evaluation will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, male and female adults, 18-30 yrs of age at Screening;
* Having no clinically significant respiratory, cardiovascular and other systemic or organic illnesses, per investigator discretion;
* Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
* Having properly consented and satisfied all other inclusion/exclusion criteria as required for this protocol.
* Other criteria apply.

Exclusion Criteria:

* A recent or significant smoking history;
* Use of prohibited drugs or failure to observe the drug washout restrictions;
* Having been on other investigational drug/device studies in the last 30 days prior to Screening.
* Other criteria apply
A Study of Glutathione in Children With Autism Spectrum Disorder

The aim of this study is to investigate if taking a supplement called Glutathione by mouth is safe and practical for children and teenagers with Autism Spectrum Disorder (ASD). The researchers plan to involve 24 individuals with ASD and give them oral Glutathione for 12 weeks.

The goal of the proposed study is to evaluate the safety and feasibility of oral Glutathione in children and adolescents who have Autism Spectrum Disorder. Twenty-four subjects with ASD will receive 12 weeks of oral Glutathione reduced. The hypothesis to be tested is that: Oral Glutathione will be effective in increasing the blood level of Glutathione, which may help to decrease some problem behaviors and irritability in this particular ASD population. The second aim of this study is to evaluate the tolerability of oral Glutathione. The proposed study may provide needed data for future studies aimed at the treatment of aggressive behaviors that can be seen in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Boys and girls ages 4-17
* Current diagnosis of Autism Spectrum Disorder as determined by criteria in DSM-5
* Parents of Children ages 4-17 with a current diagnosis of Autism Spectrum Disorder as determined by criteria in DSM-5

Exclusion Criteria:

* Unstable medical illness or clinically significant abnormalities on physical examination;
* History of seizures;
* History of Hematological disorders;
* Myocardial infarction within 6 months;
* Current pregnancy or lactation, or inadequate contraception in girls of childbearing potential;
* Current or recent (past 3 months) DSM-5 substance abuse or dependence;
* Illegal substance use within 2 weeks of study initiation;
* Previous treatment with Glutathione;
* Current treatment with N-acetylcysteine, milk thistle, Vitamin C, Vitamin B, Grape Seed Extract, Amino Acids, or Zinc
* Current treatment with Dextromethorphan, D-cycloserine, Amantadine, Memantine, Lamotrigine or Riluzole
* Asthma
Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral Load

In HIV-infected people with metabolic fatty liver disease and liver fibrosis of any degree, as measured by non-invasive testing, antiretroviral treatment that includes rilpivinire for 18 months results in a slowing of progression and/or reduction of fatty metabolic liver disease, attenuating inflammation and liver fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age with HIV infection who have never received antiretroviral treatment with Rilpivirine.
* Have a stable ART pattern for at least the last 6 month

Exclusion Criteria:

* Not having received more than three previous lines of antiretroviral treatment
* No resistance mutations that compromise the efficacy of Rilpivirine, Dolutegravir, Tenofovir (TDF and/or TAF) or Emtricitabine.
* Have an HIV viral load \< 50 copies/ml for at least the last 6 months, 1 blip below 500 copies/ml is allowed during this period.
* Have an ultrasound-diagnosed fatty liver metabolic disease or a CAP (Controlled Attenuation Parameter®) measurement \> 238 dB/m with an IQR \< 30 dB/m.
* Have an fatty liver metabolic disease with some degree of fibrosis diagnosed by ET (Fibroscan®) \> 5.2 kPa. In patients in whom ET is not possible, have a FIB-4 \>1.3.
* Be able to understand and comply with the requirements and instructions of the protocol.
* Understanding long-term commitment to study
* Acceptance of their participation in the study by signing an informed consent form.

Exclusion Criteria:

* Have chronic HBV infection (presence of HBsAg+) or HCV (detectable HCV viral load). Patients with past treated HCV are also not allowed to be included (does not include patients with spontaneously resolved HCV infection).
* Have diabetes mellitus on treatment with SGLT2, GLP1 or plioglitazone of less than 6 months duration.
* Have a history of alcohol abuse
* Harmful alcohol consumption, defined as \>30 grams of alcohol per day in men and \>20 grams of alcohol per day in women.
* Have chronic decompensated liver disease, defined as any of the following: presence of encephalopathy, ascites, coagulopathy, oesophageal or gastric varices, or persistent jaundice.
* Any previous physical or mental condition (such as habitual drug use) that the investigator believes may interfere with the patient's ability to comply with the study protocol.
* Pregnancy or breastfeeding at the screening visit or at any time during the study or intention to become pregnant during the study period.
* Prior history of Rilpivirine use of any duration.