cyrilzakka/clinical-trials huggingface dataset:
Immune Registry for BK in Kidney Transplant Recipients

Kidney transplantation (KT) is the best treatment modality available to date for patients with advanced kidney disease and the success of KT is dependent on maintaining a selective intricate balance between the risk of rejection and infections in KT recipients. BK virus is an important clinical infection affecting the post-transplant outcomes in KT recipients. BK nephropathy can affect 8-15% of patients after KT causing acute kidney injury, increased risk of rejection and fibrosis leading to additional hospital stays, increasing overall health care cost burden, and in some cases graft loss. The exact pathogenesis and treatment options for BK nephropathy are not clearly understood. It is debatable whether BK nephropathy is a full fledge donor-derived infection or reactivation of the recipient's latent infection. Irrespective of etiology, the common consensus is that treatment of BK virus infection depends on the selective restoration of host immune responses and balancing the risk of rejection vs worsening of infection.

As with other viral infections, adaptive immunity plays an essential role in the control of BK virus infection. Previous studies have shown that humoral immunity doesn't prevent viral reactivation and cellular responses including CD4+ and CD8+ T cells play a crucial role in containing viral replication. Researchers have investigated the role of reconstitution of BK-specific T cell immunity KT recipients with overall low immunological risk populations showing that pre and post-transplant BK virus-specific cellular responses can be used as an important tool to identify KT recipients at increased risk of developing BK virus infection in the first year post-transplant. We plan to understand the role of adaptive immunity (cellular and humoral interplay) in a cohort with at least 50% of high immunological KT recipients with predominantly retransplant candidates, highly sensitized recipients with calculated panel reactive antibodies \> 40 %, positive crossmatch or history of prior desensitization therapies.

The aim includes the sequential demonstration of immunogenesis processes that are specific to the BK virus in individuals who experience BK viremia and undergo various treatment approaches such as immunosuppression reduction and immune enhancement through intravenous immunoglobulins (IVIG).

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years old) male and female, deceased donor KT recipients
* Will include single organ transplants.
* Each participant must also have recently been diagnosed with BK viremia.
* In addition to the aforementioned inclusion criteria, each participant in the sub-study must also have recently been diagnosed with BK viremia or have difficult-to-treat BKV \> 3 logs (BKV log does not decrease by more than 1 log copy/ml drop on second per protocol lab).

Exclusion Criteria:

* Prisoners will not be included in the study
* Multi-organ transplants and pregnant women
Phamacokinetics and Safety Profiles of DA-5210 10/500mg in Healthy Subjects at Fed State

Phamacokinetics and safety profiles of DA-5210 10/500mg in Healthy subjects at Fed State


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* BMI between 18 and 30 kg/m2
* Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria:

* Allergy or Drug hypersensitivity
* Clinically significant Medical History
Effect of Dolutegravir Intensification on HIV-1 Reservoirs

Persistent HIV viremia occurs in most ART-treated patients and could arise from reactivation of viral expression from latently-infected cells that constitute the viral latent reservoir (LR) and/or residual ongoing viral replication during cART, for instance in anatomical compartment where drug penetration is sub-optimal.

The question of the sources of persistent viremia is of the utmost importance. If ongoing viral replication occurs, it could induce deleterious consequences on reservoirs size and immune activation.We propose to better characterize the role ongoing viral replication to HIV persistence under ART by undertaking a treatment intensification trial with high-dose dolutegravir. Tissue/blood samples and replication-competent reservoir measurements will be included as outcomes as well as immune activation markers.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected adults receiving cART for at least 3 years
* Undetectable viral for at least 3 years
* DTG/3TC/ABC as cART regimen in the previous 6 months.
* CD4 counts higher than 200 cells per μL

Exclusion Criteria:

* active hepatitis C or B
* unstable liver disease
* renal impairment (estimated glomerular filtration rate \<50 mL per min),
* gastrointestinal disorders that would affect the absorption of study treatment
* current use of drugs with significant interactions with dolutegravir
* current use of drugs with an impact on inflammation such as steroids.
* hospitalization for acute illness within the previous 8 weeks
* Pregnancy or breastfeeding.
* Anal or rectal lesions impeding rectal biopsies
* Decreased platelets count or coagulation disorder.
Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients?

Researchers from Memorial Sloan-Kettering Cancer Center, in collaboration with The New York Presbyterian Hospital-Weill Medical College of Cornell University, are conducting a study of a medicinal mushroom extract called Maitake (pronounced my-tock-e).

Laboratory studies show that Maitake can reduce the growth of cancer in animals. The Maitake does not kill cancer cells directly. It is believed to work through the immune system (the body's defense system against infection). Our test tube, animal and human dose determining studies show that Maitake can enhance immune function. We are conducting this study to see whether Maitake improves the neutrophil count and function in patients with MDS. The neutrophils are white blood cells which help to fight infection.


Eligibility Criteria:
Inclusion Criteria:

* MSKCC patients age 18 or older able to sign informed consent
* Absolute Neutrophil count \>0.5 K/mcL
* Diagnosis of MDS by bone marrow biopsy
* Patient not a candidate for aggressive standard treatment

Exclusion Criteria:

* IPSS (High risk)
* History of AML
* History of Stem Cell transplant
* Known history of HIV+
* Allergy to mushrooms
* Bone Marrow blasts \>10%

HEALTHY CONTROL ELIGIBILTY CRITERIA

Inclusion Criteria

* Age ≥55 years

Exclusion Criteria

* Currently taking corticosteroids or other immunosuppressants
* Known history of HIV+
* Current or previous malignancy or hematology disorder except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for \> 3 years
Prevention of Sacral Pressure Ulcers With Preventive Dressings

In this study we would like to find a way to prevent sacral pressure ulcers in high-risk patients by the use of a Mepilex sacral dressing. The research question we would like to answer is the following: Is the Mepilex sacral dressing a cost-effective dressing for the prevention of grade I to grade IV pressure ulcers in the sacral region in higher-risk hospitalized patients?


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18 years
* Admission in one of the ten high-risk departments of the azM
* Suspected hospital stay of 5 days or more after admission
* Braden score 19 or less

Exclusion Criteria:

* Age: \<18 years
* Pre-existing sacral pressure ulcer
* Pre-existing trauma to the sacrum
* Patient is unable to speak Dutch
* Patients with an inability to give informed consent
* Patients who are unable to give informed consent within 24h after admission
* Patients who are unable to give informed consent before surgery
Spatial Cognition Assessment in Virtual Reality

Unilateral spatial neglect (USN) is a highly-prevalent neuropsychological syndrome following a cerebral stroke characterized by massive impairments in daily life. The evaluation and the rehabilitation of USN encounter many limits whereas immersive virtual reality (VR) could be an efficient tool to go through these limits by imitating an environment of perception and action very close to the real one. The investigators will test a multisensory battery of evaluation based on VR for the diagnostic of USN.


Eligibility Criteria:
Inclusion Criteria:

* unilateral right stroke

Exclusion Criteria:

* epilepsy / migraine
* craniotomy
* major sensory/motor deficit
* severe cognitive impairment
Early Prediction of Clinical Response in Patients With Schizophrenia Treated by Paliperidone ER

Paliperidone ER is a new psychotropic medication for schizophrenia treatment. The studies of 6-week acute treatment and 52-week maintenance treatment showed positive results in patients with schizophrenia and its clinical improvement may start at Day 4. Some second-generation antipsychotics have been found that using the first 2 weeks' treatment results to predict the fourth or sixth week's treatment response is acceptable.

The primary aim of this study is to investigate:

1. . whether the early prediction model used in other atypicals could also be applied in paliperidone ER.
2. . The changes of metabolic parameters and pharmacokinetics after paliperidone ER treatment in this study

Patients diagnosed with schizophrenia or schizoaffective disorders will be enrolled in the 6-week trial. Eligible patients will receive 9mg paliperidone ER first. Then, the dosage of paliperidone could be adjusted two weeks later according to clinical judgement. They will be followed and receive assessment of pharmacokinetics, metabolic parameters ( lipid profiles, glucose, insulin, adiponectin, leptin, and prolactin, etc.), and the treatment response.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
* a minimal baseline total score of 60 on the PANSS
* those who had not received long-acting antipsychotic injection for the preceding 6 months
* physically healthy and standard clinical laboratory test results within laboratory reference ranges, or if outside the ranges, judged to be clinically insignificant by the investigators.

Exclusion Criteria:

* diagnosis of substance (including alcohol) dependence in the previous 6 months
* a medical condition that could affect absorption, metabolism, or excretion of the study drug
* substantial risk of suicide or violent behavior
* pregnancy or breastfeeding
* documented organic disease of the central nervous system
* unstable or critical untreated medical illness
* history of clozapine treatment in the previous 3 months
* participation in an investigational drug trial in the 30 days before screening.
The Use of Virtual Reality Goggles

The purpose of this research study is to evaluate the effectiveness of virtual-reality audio-visual distraction goggles on pain and behavior scores in a population of 8-12 year old dental patients receiving routine dental care in an outpatient clinical setting.

All appointments will take place at the College of Dentistry Department of Pediatric Dentistry. The first day's appointment will consist of clinically-indicated cleaning, radiographs and treatment planning. Toward the end of the first appointment, the participant will wear the virtual reality goggles for 5 minutes, in order to become familiar with the device. During these 5 minutes, fluoride varnish will be applied. The application of the varnish would occur whether the participant is in the research or not.

At the second or third appointments, the goggles will be randomly used during the restorative treatment. Whether the participant uses the goggles at the second or third visit will be determined purely by chance, like flipping a coin. No nitrous oxide will be used, but local anesthesia will still be administered as standard. The participant will use a 1-10 scale at the end of each appointment to rate pain levels, and a research team member(the dental assistant) will assign a 1-4 scale value for behavior. The 1-10 scale will consist of the Wong-Baker Faces Pain Scale.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, no history of seizures or neurological disturbance, requires two quadrants of dentistry

Exclusion Criteria:

* History of dental anxiety
Clinical Research Plan for the Safety and Accuracy of Ultrasound-guided Radial Artery Puncture Catheterization

By observing the anatomical relationship and influencing factors of the radial artery through ultrasound, the optimal puncture location is selected, and puncture catheterization is guided to reduce the number of punctures, reduce complications, and improve safety and accuracy.

Measure the anatomical parameters of the radial artery and radial nerve in the forearm using ultrasound, summarize the relevant anatomical factors that affect the placement of radial artery catheterization, and find the optimal puncture range that is both safe and accurate for radial artery catheterization.

A total of 100 surgical patients were included. Ultrasound was used to measure the transverse diameter (TDA) of the radial artery, the vertical distance (VDA) between the radial artery (center) and the skin, and the distance (D) between the superficial branch of the radial nerve and the radial artery at the midpoint between the radial styloid process point, 2.5cm, 5cm, 7.5cm, 10cm from the radial styloid process point, 2.5cm below the center of the elbow fossa, and 10cm from the radial styloid process point and 2.5cm below the center of the elbow fossa. The radial artery was compared on both sides of the patient, as well as on different genders and ages Differences in anatomical parameters and spatial relationships of the radial nerve. Patients were randomly divided into a distal group (Group A, 33 cases), a mid distal group (Group B, 33 cases), and a proximal group (Group C, 33 cases). Group A underwent radial artery puncture and catheterization within 0-5cm of the proximal end of the radial styloid process; Group B underwent radial artery puncture and catheterization within 5-10cm of the proximal end of the radial styloid process; Group C underwent radial artery puncture and catheterization within a range of 10cm proximal to the styloid process of the radius and 2.5cm below the center of the cubital fossa. The success rate, puncture time, puncture frequency, and puncture related complications of the first ultrasound-guided radial artery puncture and catheterization were recorded for three groups of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Selected surgical patients planning to undergo general anesthesia and invasive arterial blood pressure monitoring
2. ASA grading I to II
3. Age 18-65
4. Agree to participate in this clinical study and sign an informed consent form

Exclusion Criteria:

1. Patients with positive or suspected positive Allen test
2. Peripheral vascular diseases
3. Coronary artery related diseases
4. Local skin infections, ulcers, scars, and surgical history
5. Shock patients or receiving cardiac stimulants, vasoconstrictors, etc
6. Peripheral nerve injury, anatomical abnormalities, and neurological dysfunction
7. Passive upper limb position, unable to cooperate in completing ultrasound assessment
A Study to Assess Effectiveness and Safety of Fixed Dose Combination of Lopinavir/Ritonavir (LPV/r) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Patients After Switching From Kaletra in the Routine Clinical Settings of Russian Federation

This is a mixed prospective-retrospective, multi-center observational study to assess the virologic effectiveness of generic product of Lopinavir/Ritonavir (LPV/r) after switching from Kaletra in the routine clinical settings of Russian Federation.


Eligibility Criteria:
Inclusion Criteria:

* Human Immunodeficiency Virus Type-1 (HIV-1) infected patients on any dual or triple Highly Active Anti-Retroviral Therapy (HAART) with Kaletra under observation at least 48 weeks and with two consequent plasma HIV-1 RNA levels within the last 24 weeks (plasma HIV-1 RNA level \<50 copies/mL) switched to a generic LPV/r as decided by the physician in the routine clinical settings within last 24 weeks from study enrollment date.
* HIV-1 infected patients with last available CD4+ T-cell count test result \> 200 cells/mm3 before switching from Kaletra.
* Other (not LPV/r) HAART medicine components of dual or triple HIV therapy not planned to change by regular physician after switching to generic LPV/r.
* Signed Inform Consent form by patient.

Exclusion Criteria:

* Participant has contraindications for the treatment with LPV/r.
* Legal or physical incapability of patient to sign Inform Consent form
Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients

This study will randomized hematology oncology patients with active diarrhea and a NAAT positive/toxin EIA negative to either 14 days of oral vancomycin capsules or placebo. The study is designed to include 30 patients (15 per arm).

Outcomes will include C. difficile load using qPCR, VRE loads, structural and functional microbiome changes and frequency of bowel movements. All endpoints will be measured at several time points including days 0, 14, 21 and 90.

The adverse health consequences resulting from antibiotic overtreatment of NAAT(+), toxin(-) patients may be particularly important in transplant recipients. The usual treatment prescribed for CDI at the Froedtert Memorial Lutheran Hospital is oral vancomycin. While this drug has excellent activity against C. difficile and commonly suppresses its growth to non-detection, it does not eradicate carriage and its use results in marked and prolonged disruption of the lower intestinal microbiota. Meanwhile, the degree of lower intestinal microbiota disruption at the time of HSCT engraftment has been demonstrated to be an independent predictor (controlling for other markers of underlying disease) of overall and transplant-related 3-year mortality.14 In addition, recent findings suggest that bone marrow suppressive effects of antibiotics, in this case potentially unnecessary oral vancomycin (which is not appreciably absorbed), may be solely mediated via microbiota disruption. All these data supports the notion that antibiotic treatment of NAAT(+), toxin(-) C. difficile patients might have significant negative repercussions without a clear clinical benefit.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the hematology oncology inpatient units at Froedtert Memorial Lutheran Hospital
* New onset of diarrhea during hospitalization
* C. difficile clinical testing showing NAAT positive EIA negative results

Exclusion Criteria:

* Being unable to consent for self
* Inability to take enteral medications
* Unwillingness to enroll in study
* Patient has a documented allergy to vancomycin
* Patient has a documented life expectancy shorter than treatment course (14 days)
* Patient is unwilling or unable to provide stool samples in the outpatient setting after discharge
* Diagnosis of C. difficile colitis \[NAAT (+) and toxin EIA (+) within 3 months of enrollment).
* New onset of abdominal distention within 24 hours prior to the onset of diarrhea during index admission
* Presence of toxic megacolon
* Presence of clinical sepsis. Sepsis will be defined as a Sequential \[Sepsis-related\] Organ Failure Assessment (SOFA) score of 2 points or more as per 2016 definitions
* Pregnancy or lactating
Immune Checkpoint Receptors in AML-Leukemic Initiating Cells

This project aim at deciphering immune mechanisms that allow the immunoescape of AML initiating cells.

Leukemic Initiating Cells (LIC) were shown to play a key role in AML relapses, and are characterized by resistance to treatment and a high capacity to escape to immune system. Immune checkpoints (ICP) maintain self-tolerance and physiological amplitude of the immune response. We decided to focus our work on ICP receptors and ligand that could be expressed by AML LIC and lymphocytes subsets. The tumor cells are able to express these ligands to exploit the ICP to overcome the anti-cancer immune response. Few studies are published in AML in the field of ICP, some studied limited cohort and others analyzed the expression of these ligands in total leukemic population, with a limited interest since the LIC fraction represents a small subset but mainly contributes to relapse. These cells are rare and their profile of expression could be highly different but not detectable in these studies because of technical limits. We aim at analyzing ICP ligands and receptors expression at diagnosis and relapse, the phenotype of BM cells will be analyzed by flow cytometry according to different panels of monoclonal antibodies using standard immunostaining protocols.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* newly diagnosed AML

Exclusion Criteria:

* isolated extramedullary AML
* mixed phenotype acute leukemia
A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy

This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.


Eligibility Criteria:
Inclusion Criteria:

* male and female outpatients 18 to 79 years of age
* Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
* meet criteria for stage I or II hypertension
* currently not treated, or being treated with no more than two anti-hypertensive medications

Exclusion Criteria:

* type 1 or type 2 diabetes
* secondary hypertension
* evidence of other concurrent disease or conditions that might interfere with the conduct of the study
* treatment with any investigational study drug within 30 days of Screening (Visit 1)
* have a history of hypersensitivity to nebivolol or other β-blockers
Post-Market, Long-Term Follow Up of Mobi-C® Cervical Disc for One and Two Level Treatment of Cervical Disc Disease

The purpose of this study is to evaluate clinical and patient-reported outcomes at 10 years following surgery for a cohort of Mobi-C subjects treated on the IDE/Post Approval studies

This is a prospective, multi-center, consecutive cohort study. Subjects invited to participate in this study will have completed the Mobi-C IDE study (G050212). In this study, five hundred and seventy-five subjects were randomized to either the Mobi-C prosthesis or the control treatment - conventional anterior cervical discectomy and fusion (ACDF) with anterior cervical plating. The study was randomized in a 2 to 1 ratio (two Mobi-C subjects for every one subject receiving ACDF with anterior cervical plate). The subject retention rate for Mobi-C subjects was 80.1% (1 level)-84.4% (2 level) at 7 years.

As non-inferiority (1-level) and superiority (2-level) have been well established through 7 years, the design of this study will focus on the long-term outcomes of a cohort of the Mobi-C arm of the study and evaluate the durability of outcomes at 10 years. Study sites invited to participate will be those that enrolled at least 10 subjects, and also had the highest retention rates at 7 years (≥70%). All subjects at these sites will be contacted to participate in an additional 10 year follow up visit. It is estimated that up to 250 subjects will be enrolled at 9-12 study sites.

Certain endpoints are better assessed in comparison to the control ACDF arm, such as adjacent segment degeneration and subsequent surgery. This study has been amended to include a subset of sites that will also enroll control subjects. Up to 3 sites and 50 subjects will be included in this control cohort.

Eligibility Criteria:
Inclusion Criteria:

1. Prior enrollment in LDR-001 Pivotal Study (IDE G050212);
2. Written informed consent provided by subject or subject's legally authorized representative

Exclusion Criteria:

1. Documented withdrawal of consent from prior Mobi-C study;
2. Documented non-compliance (including unwillingness to return to the site for follow-up visits)
3. Reported pregnancy at time of enrollment, or with plans to become pregnant prior to completing study X-Rays