cyrilzakka/clinical-trials huggingface dataset:
Opioid, HIV and Immune System

The purpose of this research is to evaluate blood samples from HIV infected and non-HIV infected people opioid and non opioid users to understand how opioid affect the immune responses (body defenses against infection) to the flu vaccine.


Eligibility Criteria:
Inclusion Criteria:

For Opioid (OP) users/non-users:

1. OP users - prescribed opioids for at least the past 90 days; or injecting opioids for at least 90 days
2. Opioid never-users in the past year

Additional criteria for OP users:

1. OP use for 90 days pre-flu vaccination
2. Continued OP use for 4 weeks post flu vaccination

For HIV positive participants:

1) HIV infection, as documented by any licensed ELISA kit and confirmed by Western blot at any time prior to study entry. Participants on ART as a result of prior HIV documented infection will not be required to provide proof of diagnosis of HIV infection.

Additional criteria for HIV positive participants:

1. On ART for at least 1 year with plasma pending viral load (VL) \<200 copies/mL. Occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment
2. CD4 count available in the prior 6 months and \>200/mm3
3. Undetectable viral load (\< 200 copies/mL)

For HIV negative participants:

1) Documented negative HIV test, either by any licensed ELISA or rapid tests within the past 6 months.

For all participants:

1. Individuals age 18-60 yrs .
2. No history of other immunodeficiency disorders
3. Not on steroid or other immunosuppressive/immunomodulators medications.
4. No active malignancies.
5. No contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine).
6. Agreeable to receive the influenza vaccination.
7. Agreeable to participate in study for a complete course of study full visits.
8. Able to provide informed consent.

Exclusion Criteria:

1. Contraindication to receive influenza vaccination (allergy to chicken eggs or to any other substance of the vaccine).
2. Non-adherence to ART for HIV+
3. Unable to provide informed consent.
4. Other comorbid conditions such as diabetes mellitus type 2 (DMT2)
5. Influenza vaccination already given during the current vaccination season.
Human Factors and Home Use Study of the Vigilant Diabetes Management Application

A human factors and home use study to assess whether subjects with diabetes and their caregivers can understand feedback received from the Vigilant Diabetes Management Application about their blood glucose patterns and whether the decisions made in response to device feedback are made in accordance with the intended use.


Eligibility Criteria:
Inclusion Criteria:

* Persons with diabetes mellitus testing blood glucose 3 or more times per day
* Clinicians who see diabetes patients

Exclusion Criteria:

* Admission for diabetic ketoacidosis in the 6 months prior to enrollment
* A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
* Patients who are not willing to share their glucose meter data, or do not perform the tasks asked of them and follow instructions for the study will be excluded
* Pregnancy
Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)

The primary objective of LUTEGA is it to determine the long term effect (about 1 year) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy.

Furthermore, it is to be examined whether changes of the optical density are different dosages dependent. Possible changes of lipofuscin content and effect on drusen in AMD patients are studied. The measurement of optical density of macular pigment uses the 1- wavelength reflection method recording reflection images at 460 nm by a fundus camera. The patients are investigated at baseline and are followed up over one year in four more visits. In addition to the OD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample.


Eligibility Criteria:
Inclusion Criteria:

* All non- exudative forms of age related maculopathy

Exclusion Criteria:

* Exudative age related maculopathy
TAK-242 in Patients With Acute Alcoholic Hepatitis

A phase 2a double-blind, randomized, placebo-controlled, multicenter, proof-of-concept study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of TAK-242 in subjects with acute decompensation of alcohol-related cirrhosis due to alcoholic hepatitis resulting in acute-on-chronic liver failure.


Eligibility Criteria:
Inclusion Criteria:

* History of alcohol-related cirrhosis who continue to drink heavily
* History of an acute decompensating event with a clinical and/or liver biopsy diagnosis of alcoholic hepatitis
* Grade 1 or 2 ACLF using the CLIF-C OF score; OR bilirubin criteria OR criteria of acute kidney injury Stage 1b or 2 after initial supportive treatment with fluids, albumin, or terlipressin; AND CLIF-C ACLF score is \>35 and \<64
* History of alcohol-related cirrhosis based on clinical, radiological, and/or histological evidence

Exclusion Criteria:

* Received certain previous therapies (any investigational drug within 30 days of randomization, corticosteroids for alcohol-induced liver failure within 4 weeks of randomization, or received TAK-242 in any previous study)
* History of liver cirrhosis from other chronic diseases; liver failure from other causes
* History of liver transplantation, post-operative decompensation after partial hepatectomy, acute or subacute liver failure without underlying cirrhosis
* Any untreated infections including gram-positive infections, or active or latent atuberculosis, sepsis or septic shock, or coinfection with hepatitis B virus, hepatitis C virus, hepatitis E virus, or HIV
* Chronic or pre-existing kidney failure, uncontrolled medical disorder that might confound study results or compromise subject safety, oxygen saturation \<90%, or requires mechanical ventilation.
* Uncorrected anemia, methemoglobinemia, disseminated intravascular coagulation, significant or uncontrolled bleeding, atypical laboratory screening tests.
* Uncontrolled seizures, Grade 3 or 4 hepatic encephalopathy, Creutzfeldt-Jakob disease, glucose-6-phosphate dehydrogenase deficiency.
* Active extrahepatic malignancy or survival prognosis of \<6 months.
Female Genital Schistosomiasis in Tanzania

A cross-sectional survey will be conducted among 200 volunteering women aged 18- 45 years and having had prior sexual activity living in the target villages of Itilima and Maswa districts, North-western Tanzania. A single midday urine sample and two cervical-vaginal swabs (both self-collected and speculum-aided collected by a female healthcare worker) will be obtained from participating women and processed using urine filtration and polymerase chain reaction (PCR) for cervico-vaginal samples. A pre-tested structure questionnaire will be used to collect sociodemographic, clinical, and sampling acceptability information from participants.

A cross-sectional survey will be conducted among 200 volunteering women aged 18-45 years and having had prior sexual activity living in the target villages of Itilima and Maswa districts, North-western Tanzania. A single midday urine sample and two cervical-vaginal swabs (both self-collected and speculum-aided collected by a female healthcare worker) will be obtained from participating women and processed using urine filtration and polymerase chain reaction (PCR) for cervico-vaginal samples. A pre-tested structure questionnaire will be used to collect sociodemographic, clinical, and sampling acceptability information from participants. Prevalence of Female Genital Schistosomiasis (FGS) will be estimated based on positivity of at least one genital specimen. Quantitative data will be described using means/medians and standard deviation/interquartile range, as appropriate. Qualitative data will be described as numbers and percentages, and compared using Chi-squared or Fisher Exact test, as appropriate. Sensitivity of the two genital sampling methods will be compared using the composite reference constituted by positivity in at least one genital swab, and the performance of the two methods compared using Cohen's Kappa statistics, Fisher's Exact test and parametric/nonparametric test for comparison of PCR Ct values, as appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-45 years,
* having had prior sexual activity (to allow speculum-aided gynaecological visit and genital sampling),
* resident in any of the selected village of Itilima and Maswa districts,
* irrespective of complaining of urogenital symptoms,
* not reporting any exclusion criteria,
* willing to participate to the study as documented by signing the informed consent form.

Exclusion Criteria:

* Menstruation at the time of visit (since this limits visualization of the cervix and correct sampling);
* no prior sexual activity (since this does not allow the use of a speculum in the visit);
* known pregnancy;
* documented treatment for schistosomiasis in the past 6 months;
* age \<18 or \>45 years;
* unwilling to sign the informed consent form.
Evaluation of Inflammation of the Anterior Segment by Laser Flashmeter in Patients Having Undergone Surgery of the Posterior Segment (Vitrectomy or Preindentation) During the First Postoperative Year. (FLAVIC)

Observational study, monocentric, prospective, descriptive and comparative (eye operated vs fellow eye).

After surgery by vitrectomy or preindentation, an anti-inflammatory treatment is conventionally prescribed for a duration of 1 month. However, frequently, during the post-operative control at one month, there may be signs of ocular inflammation or symptoms of discomfort justifying the prolongation of post-operative treatment. A 2012 study evaluated post-operative flare follow-up in 22 vitrectomized patients for retinal detachment, and showed a significantly higher flare 3 months after surgery, compared to the other eye and pre-surgery value.

In this study, the investigators wish to study postoperative inflammation in patients operated for posterior segment ocular surgery (vitrectomy or preindentation) measured by laser flashmeter on a follow-up of one year.

Eligibility Criteria:
Inclusion Criteria:

* Major patient,
* Operation of vitrectomy or preindentation in the ophthalmology department of Rennes University Hospital for one of the following reasons:
* Retinal detachment, rhegmatogenous or not
* Combined surgery
* Membrane peeling
* Macular hole
* Optically targeted vitrectomy (Terson's syndrome, intravitreous haemorrhage)
* Covered by a health insurance system,
* Having received information on the protocol and not having expressed opposition to participating in the study

Exclusion Criteria:

* Vitrectomy for endophthalmitis or posterior uveitis,
* Patient with vitreoretinal proliferation (grade B and C),
* Pregnant or nursing woman,
* Major patient subject to legal protection (safeguard of justice, guardianship, guardianship), person deprived of liberty.
Role of Topical Oxytocin Gel in Post-Menopausal Women

Aim of the current study:

To evaluate the effect of a14 day treatment period with local intravaginal application of an oxytocin-containing gel on vaginal atrophy, psychosexual and psychological/cognitive function, and metabolic, stress, and inflammatory parameters in Egyptian post-menopausal women


Eligibility Criteria:
Inclusion Criteria:

* The women were post-menopausal and were between 47 and 67 years old
* The women's last menstruation had occurred more than one year prior to the study
* The women had an established vaginal atrophy
* The women scored \< 26 in the Female Sexual Function Index (FSFI)
* The women had an active sexual relationship

Exclusion Criteria:

* Women who smoked
* Women who used hormone replacement therapy
* Women using a vaginal lubricant
* Women having any vaginal bleeding or any breast diseases
* Women having any undiagnosed genitalia disorder
* Women suffering from chronic diseases such as diabetes, hypertension, cardiovascular disease, or psychiatric disease
Severe Asthma Research Program - Wake Forest University

The mission of SARP is to improve the understanding of severe asthma through the integrated study of the effect of genetics on the clinical and biological features of asthma and to investigate how these change over time. The ultimate goal of these efforts is to promote better treatments for severe asthma.

The mission of the SARP is to improve the understanding of severe asthma to develop better treatments. The SARP will gain a better understanding of asthma and its endotypes, in children and adults, by defining the disease at the molecular and cellular levels in the context of the temporal phenotypic expression of the disease. To this end, the SARP investigators will utilize both mechanistic and evoked phenotype approaches to: 1) characterize developmental molecular, cellular and physiologic phenotypes in children and adults with mild to severe asthma, and 2) to further elucidate the evolving pathobiology and pathogenesis of severe asthma and its sub-phenotypes and 3) compare these features over time. This approach involves a shared longitudinal protocol conducted across all participating centers which includes common information on all SARP participants. Additionally, SARP investigators have each identified mechanistic research questions to be included in the shared longitudinal protocol. At Wake Forest University investigators are specifically interested in genetic influences on disease severity and the use of statistical modeling techniques to better understand disease phenotypes. Together, these longitudinal and mechanistic approaches will enable prediction of phenotype stability/fluctuation and pharmacologic responses and identification of novel, disease-modifying targets for treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Physician diagnosis of asthma,
2. Age 6 years and older
3. Evidence of historical reversibility, including either:

   * FEV1 bronchodilator reversibility ≥ 12%, or
   * Airway hyperresponsiveness reflected by methacholine PC20≤16 mg/mL.

Exclusion Criteria:

1. No primary medical caregiver
2. Pregnancy (only if undergoing methacholine challenge or bronchoscopy)
3. Current smoking
4. Smoking history \> 10 pack years if ≥ 30 years of age or smoking history \>5 pack years if \< 30 years of age (Note: If a subject has a smoking history, no smoking within the past year)
5. Other chronic pulmonary disorders associated with asthma-like symptoms, including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic bronchitis, vocal cord dysfunction that is the sole cause of asthma symptoms, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways
6. History of premature birth before 35 weeks gestation
7. Planning to relocate from the clinical center area before study completion
Mobile Phone Based Intervention to Protect Mental Health in Healthcare Workers at Frontline Against COVID19

This study aims at evaluating the effectiveness of a mobile phone based intervention to prevent and manage mental health problems in healthcare workers at the frontline against COVID-19 in Spain. The intervention will consist in psychoeducation, delivered via a mobile App. Participants will be followed up during two weeks. The primary outcome will be symptomatology of depression, anxiety or stress.

Healthcare workers (HCWs) commonly present high levels of anxiety, depression, posttraumatic stress, acute disorder and burnout, both during and after viral outbreaks. Although educational and multifaceted interventions might mitigate the development of mental health problems, the certainty on the evidence is very low. The aim of this double-blinded randomized clinical trial is to examine the impact of a mobile phone based intervention to prevent and manage mental health problems in healthcare workers at the frontline against COVID-19 in Spain.

The trial will include HCWs having provided healthcare to patients with COVID19 in a healthcare centre (any setting) in Spain during the viral outbreak in Spain. Professionals from any medical speciality and role (doctors, nurses, nurse assistance, etc.) with access to a smartphone will be included. The investigators will collect expressions of interest via dissemination of the study through social media and key stakeholders (hospital managers, scientific societies and professional colleges). A team of psychologists will contact (via telephone) potential participants to confirm they meet the eligibility criteria (described above), obtain signed consent (audio-recorded), and carry out a psychological (pre-intervention) evaluation. The participants will then be randomly allocated to receive a fully functional App (full intervention) or an App with brief generic recommendations about mental health (control intervention). A post-intervention psychological assessment will be undertaken after two weeks. The primary outcome will be symptomatology of depression, anxiety or stress. Secondary outcomes will include posttraumatic stress, burnout, insomnia, and self-efficacy. After the two weeks follow-up, all participants allocated to the control intervention will be offered the full intervention.

Eligibility Criteria:
Inclusion Criteria:

Healthcare workers having provided healthcare to patients with COVID19 in a healthcare centre (any setting) during the viral outbreak in Spain.

We will include professionals from any medical speciality and role (doctors, nurses, nurse assistance, etc.).

Exclusion Criteria:

We will exclude healthcare workers not able to use, or with no access, to a smartphone.
Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.

The purpose of the study is to compare the pharmacokinetics of nebulized amikacin administered with three vibrating mesh nebulizers coupled with a single limb circuit bilevel ventilator in healthy volunteers. Following our previous in vitro study, our hypotheses are that the pharmacokinetics varies among the devices tested and that a most efficient device can be identified.


Eligibility Criteria:
Inclusion Criteria:

* No contraindication of amikacin
* Written informed consent
* Negative pregnant test (for women)

Exclusion Criteria:

* History of respiratory disease
* History of renal disease
* History of otological disease
CerviPrep for Applying Topical Gemcitabine to the Cervix in Treating Patients With Primary Endometrial, Cervical, or Ovarian Epithelial Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Using the CerviPrep™ drug delivery device to apply topical gemcitabine to the cervix may be an effective way to kill more tumor cells.

PURPOSE: This phase II trial is studying how well CerviPrep™ works in applying topical gemcitabine to the cervix in treating patients with primary endometrial cancer, cervical cancer, or ovarian epithelial cancer.

OBJECTIVES:

Primary

* To evaluate the efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix

Secondary

* To document any side effects directly attributed to local administration of gemcitabine hydrochloride.

OUTLINE: Patients undergo application of topical gemcitabine hydrochloride directly to the cervix using the CerviPrep™ drug delivery device during routine hysterectomy.

Uterine vein and peripheral blood samples are obtained periodically to measure local and peripheral gemcitabine hydrochloride concentration levels in the blood. Local gemcitabine hydrochloride concentration levels are also measured in uterine tissue samples obtained from the surgical specimen after hysterectomy.

Patients complete a self-reported symptom diary for the first 7 days after surgery for assessment of local and systemic side effects associated with topical administration of gemcitabine hydrochloride.

After completion of study therapy, patients are followed at 2-4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary endometrial or cervical cancer
* Scheduled to undergo abdominal hysterectomy as part of surgical staging and/or treatment
* Gynecologic Oncology Group (GOG) performance status 0-2
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³
* Platelet count ≥ 100,000 cells/mm³
* Creatinine ≤ 2.5 mg/dL
* Serum Aspartate aminotransferase (AST) or Alanine transaminase (ALT) ≤ 3 times upper limit of normal
* Total bilirubin ≤ 2.0 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

Exclusion Criteria:

* Serious medical condition or psychiatric illness that places the patient at an unacceptable risk for study participation or precludes signing the informed consent
* Known allergic reaction or hypersensitivity to gemcitabine hydrochloride
* Prior radiotherapy to the whole abdomen or pelvis
* More than 28 days since prior standard or experimental anticancer therapy
* No other concurrent anticancer agents
Effects on Glycemia and Insulinemia of Different Grape Varieties

The goal of this intervention study is to examine the glucose increase in blood, during 2 hours after consuming different varieties of grapes, in men and women with normal or excess body weight. The main question it aims to answer is:

can a variety of red grape reduce the glucose curve compared to a reference variety?

Participants will have to attend the Center for nutrition research facilities in three occasions, fasted for at least 8 hours. Once there, they will be measured and monitored. A canula will be inserted and once they finish eating 300g of grapes, blood extractions will be performed at minutes 15, 30, 60, 90 and 120.

The main purpose of this study is to evaluate how the glucose and insulin curves develop after consuming different grapes varieties. Still, we also want to evaluate how the serum metabolome changes with the three varieties after 120 minutes. Therefore, a metabolomic study will be done in samples of volunteers at this time point.

The intervention is longitudinal and in three arms (one per variety). Due to the harvest of the different varieties, it cannot be crossover, but each subject will consume the three varieties.

At each visit, the subjects will undergo the same schedule:

* Arrival in a fasting state of at least 8 hours.
* Insertion of cannula and extraction of fasting samples
* Consumption of approximately 300 g of grapes (50 g of Carbohydrates).
* Extraction of blood samples at 15, 30, 60, 90 and 120 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Baseline glycaemia between 70 and 100 mg/dL
* BMI between 18.5 kg/m2 and 29.9 kg/m2.
* Absence of disease or alterations related to gastrointestinal status.
* Signed written informed consent.

Exclusion Criteria:

* Glycaemic levels out of the reference inclusion criteria (below 70 or over 100 mg/dL)
* Subjects presenting BMI out of the limits set.
* Subjects with unstable body weight the three months prior the start of the study (+/- 3 Kg)
* Subjects not able to attend the preestablished visits
* Women pregnant or lactating
* Subjects undergoing pharmacological treatment