cyrilzakka/clinical-trials huggingface dataset:
Observational Registry Study of Chinese Patients Treated With Revlimid (Lenalidomide)

The primary objective of this study is to document efficacy and safety data in a real-world setting of Chinese multiple myeloma patients who have received at least one prior therapy treated with REVLIMID (lenalidomide).

This registry is prospective, multi-center, observational study and will collect efficacy and safety data on multiple myeloma adult patients who have received at least one prior therapy and take REVLIMID as part of standard care associated with patients' treatment in order to characterize the use, efficacy and outcomes of REVLIMID treatment.

The registry will capture data from 600 patients being prescribed REVLIMID in specified hospitals and all patients will be followed in the registry for two years after enrollment of the last patient.

Eligibility Criteria:
Inclusion Criteria:

* Must understand and voluntarily sign written informed consent At least 18 years old at the time of signing informed consent Diagnosed with Multiple Myeloma Must have received at least one prior Multiple Myeloma treatment at the time of signing informed consent

Exclusion Criteria:

* None
Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination

The purpose of this study was to compare the safety and intraocular pressure (IOP)-lowering efficacy of a new fixed combination of brinzolamide/brimonidine (Brinz/Brim) to:

* its individual components (Brinz and Brim), and
* the concomitant administration of Brinz and Brim (Brinz+Brim).

This study consisted of 5 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and the treatment phase, which included 2 on-therapy visits conducted at Week 2 and Week 6 (or early exit). A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 4 study drug groups for 6 weeks. Study drug instillation began the morning after the second eligibility visit. The study was terminated by the sponsor out of caution due to microgel formation in the Brinz/Brim formulation. 13 remaining active subjects were discontinued. Further analysis revealed that neither the drop size nor the concentration of the active ingredients was affected.

Eligibility Criteria:
Inclusion Criteria:

* Sign Informed Consent document.
* Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
* Any form of glaucoma other than open-angle glaucoma.
* Severe central vision loss in either eye.
* Chronic, recurrent, or severe inflammatory eye disease.
* Ocular trauma within the preceding 6 months.
* Ocular infection or ocular inflammation within the preceding 3 months.
* Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
* Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
* Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
* Ocular surgery within the preceding 6 months.
* Ocular laser surgery within the preceding 3 months.
* Any abnormality preventing reliable applanation tonometry.
* Any other conditions, including severe illness, which could make the patient, in the opinion of the Investigator, unsuitable for the study.
* Other protocol-specified exclusion criteria may apply.
Sleep Disordered Breathing, APOE, and Lipid Metabolism

To examine the relationship between obstructive sleep apnea and lipid metabolism.

BACKGROUND:

Recent findings suggest interrelationships between obstructive sleep apnea, lipid metabolism, and neurodegeneration. Apolipoprotein E epsilon4 (APOE e4), a genetic marker linked to increased cardiovascular disease (CVD) risk and Alzheimer's disease (AD), is associated with a two fold increased risk of sleep disordered breathing (SDB), and an increase in severity of apnea symptoms. Preliminary data suggest that this association is stronger between the ages of 50 and 65. Other experiments suggest dysregulated leptin levels in obstructive sleep apnea (OSA). Taken together, these findings suggest common pathophysiological mechanisms involving dysregulated lipid metabolism in OSA. An understanding of these mechanisms is essential for the prevention and treatment of SDB.

DESIGN NARRATIVE:

Using case/control and family designs, the study: 1) extends the finding that apolipoprotein E epsilon4 (APOE e4) increases the risk of sleep apnea in the general population; 2) examines if polymorphisms in other genes regulating lipid levels are associated with sleep apnea; 3) studies the relationship between lipid regulatory gene polymorphisms, lipid profile (LDL- cholesterol, HDL-cholesterol, triglycerides), plasma leptin (and other lipid regulatory hormones), and sleep apnea levels.

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Eligibility Criteria:
No eligibility criteria
Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis

This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The study consists of a double-masked phase, and open-labeled phase, and an open-labeled maintenance phase. For the first 3 months of the study, patients will receive either masked Cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients may receive open-labeled Cyclosporine 0.010% eye drops four times daily. At month 9, patients who are in remission, will be re-randomized to receive either open-labeled Cyclosporine 0.010% eye drops four times daily or twice daily.


Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye)
* Be on stable doses of your current AKC medications for at least 2 weeks

Exclusion Criteria:

* You have used contact lenses within 48 hours of Day 1 or think you may have to wear contact lenses during the study
* You are pregnant, breastfeeding, or planning to become pregnant during the study
* You have used a calcineurin inhibitors (e.g. topical tacrolimus or topical pimecrolimus) on or around your eyes including eyelids within 4 weeks
Study on Low Dose Temozolomide Plus Metformin or Placebo in Patient With Recurrent or Refractory Glioblastoma

A phase 2 clinical trial for the efficacy and safety of low dose Temozolomide plus metformin as combination chemotherapy compared with low dose Temozolomide plus placebo in patient with recurrent or refractory Glioblastoma

Studies will investigate the efficacy and safety of low dose Temozolomide with Metformin or placebo for the patients with recurrent or refractory Glioblastoma.

The dosage of the Metformin will follow the domestically permitted dose to minimize side effects.

The patients will be allocated randomly to arm 1(experimental) and arm 2(placebo controlled) and administered the investigational products for up to 6 cycle. Each cycle consists of 4 weeks.

After 6 cycle(24 weeks), the patients will be checked progression and survival every 24 weeks up to 96 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Progressive or recurrent Glioblastoma conformed by histopathological or radiological diagnosis. Progressive or recurrent Glioblastoma during or after standard therapy (Temozolomide after Temozolomide and radiation therapy; Stupp regimen) after histopathological diagnosis of Glioblastoma Recurrence or progression is diagnosed according to histopathological diagnosis or revised RANO(Response Assessment in Neuro-Oncology) criteria c
2. Karnofsky performance status(KPS) ≥ 60%
3. Age ≥ 19 years old
4. At least 4 weeks after operation or chemotherapy
5. Normal in hematological finding, liver and kidney function

   * Hematology ANC \> 1.500/mm³, Platelet \> 100,000/mm³, WBC \> 3×10\^9/L, Hemoglobin \> 9g/dL
   * Liver function Total Bilirubin level ≤ 1.5×ULN(in case of isolated hyperbilirubinemia ≤2.5 x ULN) AST / ALT \< 2.5×ULN
   * Renal function Serum creatinine ≤ 1.5mg/dL
6. Be informed of the nature of the study and obtained a written informed consent
7. A legal representative agrees to the trial when a subject is unable to communicate smoothly due to neurologic defect
8. If a fertile woman who has been confirmed negative to a urine or blood pregnancy test within 28 days prior to the trial

Exclusion Criteria:

1. Pregnant or breast feeding
2. Cancer history within 5 years excluding cancer in the skin cells and cervix
3. Active infections within two weeks
4. Leptomeningeal metastasis
5. Patients diagnosed with diabetes
6. Hypersensitive or intolerance to Metformin
7. Patients who are currently taking Metformin, sulfonylureas, thiazolidinediones, and insulin, regardless of reason
8. Other serious diseases or medical conditions that include :

   * Patients who suffer from unstable heart disease despite treatment.
   * Patients having a heart attack within 6 months prior to the start of trial
   * Patients who suffer from severe nerve or psychosis that includes dementia or strokes.
   * Patients with an uncontrolled infection
   * Patient with uncontrolled hypertension, congestive heart failure, unstable angina, or incomplete arrhythmia
9. Those who have participated in other clinical trials may not recover from the toxicity of the treatment.
A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies

This study is designed to follow up patients who have achieved complete clearance of AK lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.

A 12 month long-term follow-up study of patients who have achieved complete clearance of AK lesions at the Day 57 in the Phase 3 studies PEP005-016 or PEP005-025.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have achieved complete clearance of AK lesions (lesion count = 0) at Day 57 in one of the following Peplin AK clinical studies: PEP005-016 or PEP005-025
* Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures

Exclusion Criteria:

* Concurrent participation in another research study which would involve the selected treatment area (except for any post-study follow-up visits for previous Peplin AK study)
* Early termination from study PEP005-016 or PEP005-025
Rifaximin Therapy in Chronic Kidney Disease

The purpose of this study is to determine if Rifaximin decreases serum and urine levels of bacterial byproducts and inflammatory markers in patients with chronic kidney disease and to evaluate changes in the bacterial content of the stool from these individuals.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease with eGFR ≤ 39 ml/min/1.73m2

Exclusion Criteria:

* Patients with normal renal function or those with less advanced kidney disease
* Inability or unwillingness to provide consent
* Patients undergoing hemodialysis or peritoneal dialysis therapy or those who have undergone organ transplant
* Patients who may be pregnant
* Hemodynamically unstable patients
* Patients with liver failure, pancreatic insufficiency, or inflammatory bowel disease
* Patients with ongoing or recent infection and those with history of C-diff infection
* Patients with abnormal bowel structure secondary to surgical or anatomic variations
* Patients on certain medications including immunosuppressants, antidiarrheal agents, bile acid sequestrants and current or recent (within the last 3 months) use of antibiotics
10 Versus 20 Minutes Treatment of Human Pericardium With Glutaraldehyde in OZAKI Procedure

To compare mechanic and thermic stability of pericardium fixated either with 0.6% glutaraldehyde for 10 minutes or with 0.6% glutaraldehyde for 20 minutes

Autologous pericardium for aortic valve reconstruction is treated with 0.6% glutaraldehyde for 10 minutes to improve stability (OKAZI technique).

This study investigates whether treatment with 0.6% glutaraldehyde for 20 minutes improves mechanic and thermic stability of autologous pericardial tissue. Autologous pericardium remaining after aortic valve reconstruction surgery is used.

To investigate 10 versus 20 minutes treatment of removed original aortic valve tissue with glutaraldehyde as a reference.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing aortic valve surgery with sufficient leftover tissues from the OZAKI procedure (excess of pericardium and calcified aortic valve leaflets)

Exclusion Criteria:

* denial of consent
* insufficient leftover tissues from the OZAKI procedure
* patients after thoracic radiation or surgery
To Investigate the Effect of Tart Montmorency Cherry Juice (Prunus Cerasus) on Vascular Function.

Given the global health issues associated with poor cardiovascular function, interventions that help reduce the severity, with emphasis on prevention would not only have economic implications, but would also improve health, wellbeing and quality of life. Research provides evidence that consumption of a diet high in plant foods and rich is polyphenols is associated with a reduction in the incidence of cardiovascular disease (Hung et al 2004). Tart Montmorency cherries have been shown to be high in numerous phytochemicals (Wang et al 1999; Seeram et al 2001). Several of these compounds, are known to be vasoactive and improve blood vessel function by increasing bioavailability of vasodilators (Mudnic et al 2012), reducing vasoconstrictors (Broncel et al 2010), decreasing platelet aggregation (Hubbart et al 2006) and increasing blood vessel dilation (Schroeter et al 2006). Impaired function of the lining of blood vessels (endothelial dysfunction) has been linked to increased risk of cardiovascular disease. However, the bioavailability of all the compounds in Tart Montmorency Cherry Juice and their efficacy with respect to vascular function has not been fully determined. This study will examine the influence of tart Montmorency cherry juice on cardiovascular function, specifically arterial stiffness by pulse wave velocity and blood flow in the microcirculation by laser Doppler imaging. This study will also examine digital volume pulse and pulse wave analysis. These data will provide information on the ability of TMCJ to affect blood flow and vascular function.

Participants provided blood samples immediately before supplementation and sequentially 8h post ingestion. Additionally, vascular measurements including laser Doppler imaging (LDI), pulse wave analysis (PWA), pulse wave velocity (PWV), digital volume pulse (DVP) and blood pressure (BP) were performed with the participant in a supine position. LDI, PWV, PWA, and DVP were measured at 1, 2, 3, 5 and 8h intervals. BP was performed at hourly intervals. All vascular measurements took place on the non - cannulated arm. No additional food or fluid was provided during the study period except for low-nitrate mineral water. Following a minimum of two weeks washout, the participants were required to return to the laboratory to repeat the procedure with the other intervention drink.

Eligibility Criteria:
Inclusion Criteria:

* Those with blood pressure below 140/90
* Males
* Aged 21 - 55y

Exclusion Criteria:

* Those with blood pressure above 140/90
* Taken other medication/ supplements.
* Those aged \>21 or \<55.
A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-Risk Adults Aged 18 to 65 Years Inclusive.

The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).


Eligibility Criteria:
Inclusion Criteria:

1. 18 - 65 years of age inclusive who have given written informed consent at the time of enrollment;
2. Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);
3. In good health as determined by medical history, physical examination and clinical judgment of the investigator;
4. Who are or might be routinely exposed to cultures of N. meningitidis serogroup B.

Sponsor's employees are considered eligible to participate in the trial as per inclusion criteria.

Exclusion Criteria:

1. Pregnancy or nursing (breastfeeding) mothers;
2. Females of reproductive age who have not used or do not plan to use acceptable birth control measures, for the 3 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods for at least 60 days prior to study entry;
3. Any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease);
4. Individuals with history of any progressive or severe neurologic disorder, or seizure disorder. A single episode of febrile convulsion is not an exclusion criteria;
5. History of any serogroup B meningococcal vaccine administration;
6. Previous known or suspected disease caused by N. meningitidis;
7. History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine;
8. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):

   * Receipt of any chronic immunosuppressive therapy
   * Receipt of any chronic immunostimulants
   * Immune deficiency disorder, or known HIV infection
9. Subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study;
10. History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
11. Any significant chronic infection;
12. Known bleeding diathesis or any condition that may be associated with a prolonged bleeding time;
13. Family members and household members of research staff;
14. Participation in another clinical trial within the last 30 days or planned for during study.
Diagnostic Study of Biomarkers in BAL of ICU Patients With Lung Infiltrates

The aim of this project is therefore to explore on the clinical significance of analyzing surrogate markers combined with conventional diagnostics in the ICU setting. BAL, blood and biopsy samples will be subjected to a combined analysis of GM, BDG, Aspergillus specific PCR assays in addition to conventional diagnostics (Microscopy, Culture,Histology) for ICU pts with pulmonary infiltrates.

As GM and BDG are not species-specific, three established and repeatedly published species specific PCR-based assays (nested PCR, real time PCR assay, multifungal DNA Array)developed by our group will be investigated in combination with the serological tests in a multicenter prospective clinical diagnostic trial.


Eligibility Criteria:
Inclusion Criteria:

* underlying conditions (see above)
* being on mechanical ventilation
* lung infiltrates

Exclusion Criteria:

* immunocompetent patients (not fulfilling the criteria above)
Microcirculatory Vasomotor Changes in Type 2 Diabetes With Peripheral Neuropathy

Microcirculatory flow is subject to cyclic changes under the influence of heart rate, respiration, myogenic activity, neurogenic factors and endothelial factors. Microcirculatory oscillations (vasomotion) contribute significantly to tissue perfusion. Vasomotion analysis allowed to discriminate normoglycemic subjects, prediabetic subjects and diabetic subjects. Furthermore, changes in vasomotion can precede the emergence of global signs of microangiopathy complications in type 2 diabetes. In fact, few studies reported impaired vasomotion in type 2 diabetes with peripheral neuropathy. Vasomotion analysis after vasodilator (6-min walking test and hyperthermia) and after vasoconstrictor (foot lowering) stimulus could be an effective diagnostic tool to sharpen the diagnostic.

Objectives and Methodology: to study vasomotion at baseline and after exercise, hyperthermia and foot lowering within 3 groups of patients: diabetic without peripheral neuropathy, diabetic with subclinical peripheral neuropathy and diabetic with peripheral neuropathy and one group of sex- age- and body mass index-matched healthy control subjects.

All the subjects will benefit from a clinical, anthropometric, level of physical activity and biological evaluations. Type 2 diabetes participants will benefit from neuropathy evaluation. In addition, cutaneous microcirculation (perfusion and vasomotion) by means of Laser Doppler Flowmetry and Laser Speckle Imaging will be recorded at rest and after different stimuli (exercise, hyperthermia and foot lowering).

All the subjects will benefit from a:

* clinical: diabetes duration, treatments
* anthropometric: weight, height, BMI
* level of physical activity by means of the International Physical Activity Questionary, pedometers and the 6 minutes walking test
* biological evaluations: glycemia, HbA1C, lipids, high sensitive C-reactive protein, fibrinogen, 25(OH)D, creatinine, albumine Type 2 diabetes participants will benefit from neuropathy evaluation: sensory tests by means of Semmes-Weinstein monofilament and of Nerve Check, amplitude and velocity sural nerve and neuropathic symptom score (NSS) In addition, cutaneous microcirculation (perfusion and vasomotion) by means of Laser Doppler Flowmetry and Laser Speckle Imaging will be recorded at rest and after different stimuli (exercise, hyperthermia and foot lowering).

Eligibility Criteria:
Inclusion Criteria:

* For diabetic patients, HbA1C \>6.5 and diabetes duration \>5years
* For healthy control no diabetes mellitus, no cardiovascular or renal pathology

Exclusion Criteria:

* nondiabetic neuropathy
* on medication known to affect microcirculation
* presence of active foot ulcer or wound healing history \<3months
* inability to walk 6 minutes
* alcohol consumption of more than 3 units per day
STIM+: PET Biomarker Education & Disclosure

When dementia is caused by AD, we refer to it as dementia of the Alzheimer's Type (DAT). The greatest risk factor for Alzheimer's Disease (AD) and DAT is advancing age, but DAT is not a normal part of aging. Studies have shown that changes in the brain happen before full symptoms of DAT develop. These changes include a buildup of two proteins within the brain, called amyloid and tau. The two goals of this study are

(1) to determine whether patients with mild cognitive impairment or dementia-Alzheimer's type (DAT) are able to demonstrate decisional capacity to engage in PET amyloid and tau disclosure after receiving education; and (2) to assess how patients and care partners react to PET amyloid and tau biomarker disclosure.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the Stimulation to Improve Memory Study (NCT03875326).
* Completed PET scan with amyloid and/or tau tracer success.
* Demonstrates decision-making capacity to engage in PET disclosure, or has a care partner in attendance that demonstrates decision-making capacity for the participant to engage in disclosure
* If diagnosed with DAT: must have a cognitively intact study partner (i.e., their care partner)
* If diagnosed with MCI: strongly recommended to have a cognitively intact study partner (i.e., their care partner)

Exclusion Criteria:

* Active diagnosis of moderate depression or anxiety without treatment
* Newly diagnosed neurologic disease (since completion of Stimulation to Improve Memory Study activities)