cyrilzakka/clinical-trials huggingface dataset:
Vaccine Therapy With or Without Donor Lymphocyte Infusion in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Multiple Myeloma Undergoing Donor Stem Cell Transplant

RATIONALE: Vaccines made from the patient's cancer cells may help the body build an effective immune response to kill cancer cells. Giving vaccine therapy together with donor lymphocyte infusion after a stem cell transplant from the patient's brother or sister may kill any cancer cells that remain after transplant.

PURPOSE: This clinical trial is studying the side effects, best dose, and how well vaccine therapy with or without donor lymphocyte infusion works in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, or multiple myeloma undergoing donor stem cell transplant.

OBJECTIVES:

* Determine time to relapse and overall survival of patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, or multiple myeloma treated with autologous tumor cell vaccine with or without donor lymphocyte infusion after HLA-matched related sibling nonmyeloablative hematopoietic stem cell transplantation.
* Evaluate the safety and tolerability of this regimen in these patients.
* Determine the maximum tolerated dose of donor lymphocyte infusions in these patients.

OUTLINE: Patients undergo collection of tumor cells for production of the cancer cell vaccine and then undergo HLA-matched related sibling nonmyeloablative hematopoietic stem cell transplantation (HSCT). Patients then receive cancer cell vaccine with or without donor lymphocyte infusion. The donor lymphocytes are obtained from the same relative who donated stem cells for the HSCT.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Confirmed diagnosis of 1 of the following:

  * Acute myeloid leukemia (AML), meeting any of the following criteria:

    * Relapsed disease
    * AML arising from myelodysplastic syndromes
    * Primary refractory disease
    * De novo AML with high-risk features
  * Acute lymphoblastic leukemia (ALL), meeting any of the following criteria:

    * De novo ALL that is Philadelphia chromosome positive or with t(4,11) cytogenetic features
    * Relapsed disease
  * Multiple myeloma (in need of treatment)
* Planning to undergo HLA-matched related sibling nonmyeloablative hematopoietic stem cell transplantation

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Clinical Evaluation of the Antibacterial Activity of Thioglycosides Extracted from White Mustard - Bamberka in Oral Hygiene. Evaluation of Periodontal Parameters and Oral Microbiota in Patients.

Brief Summary

The goal of this randomized clinical trial is to evaluate the clinical and antibacterial effects of a herbal toothpaste containing white mustard (Sinapis alba) extract in patients diagnosed with gingivitis. The main questions it aims to answer are:

Does the herbal toothpaste significantly reduce plaque index (PI), approximal plaque index (API), gingival index (GI), and bleeding on probing (BoP) compared to a placebo toothpaste?

Does the herbal toothpaste effectively reduce the bacterial loads of Streptococcus mutans and Lactobacillus spp. in saliva compared to a placebo?

Researchers will compare the effects of the herbal toothpaste to a placebo toothpaste to determine its efficacy in improving periodontal parameters and reducing bacterial levels.

Participants will:

Be randomly assigned to one of two groups: test group (herbal toothpaste) or control group (placebo toothpaste).

Use the assigned toothpaste twice daily for 4 weeks.

Undergo clinical evaluations at baseline (T0) and after 4 weeks (T1), including measurements of PI, API, GI, and BoP.

Provide saliva samples at T0 and T1 for microbiological analysis of Streptococcus mutans and Lactobacillus spp. bacterial loads.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65 years,
* the presence of at least 20 teeth excluding third molars,
* a diagnosis of gingivitis according to the 2017 World Workshop
* non-smokers.
* the motivation to take part in the study,
* proper oral home hygiene
* sign a consent agreement for the participation in the study

Exclusion Criteria:

* patients aged \<18
* the presence of less than 20 teeth
* severe systemic diseases and diseases that require regular systemic drugs (diabetes mellitus)
* the use of systemic antibiotics during the last 3 months or local antiseptics that may affect biofilm formation (antibacterial mouth rinses containing chlorhexidine 4 weeks or less prior recruitment)
* allergy to mustard or any other compound of experimental toothpaste
* patients undergoing orthodontic treatment
* women who were pregnant or breastfeeding.
Identification of Clinically Relevant Markers of Deep Brain Stimulation Electrode Impedance

The study will look into the changes of Deep Brain Stimulation (DBS) measured impedances in patients of Parkinson disease (PD) as a function of their functional state (lying, sitting and walking) and dopaminergic medication intake (levodopa or dopamine agonists).

The goal is to use DBS measured impedance as a surrogate of the functional and medication states of PD patients.

Subjects will be recruited from the population of patients who are already implanted with DBS for treatment of PD.

At the patient's follow up visit they will be asked to come to the clinic in the "off medication" state. Off medication is defined as at least 8 hours since the last medication dosing. Data will be collected during three phases: "OFF" state, transitioning state, and "ON" state. Subjects will be asked to assume different functional states (lying, sitting or walking) for 1 minute each. During these functional states, multiple measures of impedance will be collected.

* "OFF" state data collection: The subject will be examined to assess his motor examination score using the UPDRS-III. Measurements of impedance will be collected multiple times in the lying down and sitting up states.
* Transition state data collection: The subject will be asked to take their dopamine medication. The medication will take approximately 1 hour to take full effect. Measurements of impedance will be collected every 10 minutes during this transition from the "OFF" state to the "ON" state. Patients will be asked to report at what point they felt the "ON: state (they can report the state as "OFF", "unsure", "transition" or "ON").
* "ON" state data collection: The "ON" state examination will start after 1 hour from medication administration. Subjects will be examined using the UPDRS-III. Measurements of impedance will be collected in the lying down, sitting and walking states.

Summary of the study protocol:

"OFF" state Transition state "ON' state UPDRS-III x x Impedance Lying down x x Sitting up x x x Walking x UPDRS I and II x Hoehn and Yahr x x

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's patients with DBS (unilateral or bilateral)
* Must be taking dopamine agonist or levodopa regimen
* Medtronic Neurostimulator Activa SC, PC or PC+S (IPG)

Exclusion Criteria:

* Hoehn and Yahr (H\&Y) 4 and above
* History of DBS revision or lead replacement surgery
* Current or prior non-Medtronic Activa SC, PC or PC+S IPG
* Historical information of more than 1 hour delay to "ON" state as average
Iloprost in Gas Exchange/Pulm Mechanics in Chronic Obstructive Pulmonary Disease (COPD)

The investigators believe that iloprost will improve gas exchange in COPD patients with pulmonary hypertension.

Pulmonary hypertension and right heart failure can complicate the management of the patient with advanced COPD. Attempts to treat this pulmonary hypertension with systemic vasodilators frequently result in a worsening of ventilation perfusion matching and an increase sense of dyspnea. This study will look at the effect of an FDA approved pulmonary vasodilator, iloprost, on gas exchange and pulmonary mechanics in patients with COPD. Ten clinically stable patients will be enrolled. They will report to the lab on the morning of the study and after an arterial line is placed, pulmonary function measurements and arterial blood gases will be obtained. Iloprost (2.5 mcg via nebulizer) will be administered and the effect upon arterial blood pressure, respiration and arterial saturation will be monitored. Pulmonary function tests (PFTs) and blood gases will be repeated after 30 minutes. Patients who remain clinically stable without evidence of a fall in arterial PO2 or systemic blood pressure would inhale a second dose of 2.5 mcg of iloprost. The patient will be monitored for a minimum of 2 hours after their last dose of iloprost. Primary outcome variable will be the alveolar arterial O2 difference while secondary outcomes will include PAO2, venous admixture, FVC and FEV1, DLCO and ventilatory equivalents for O2 and CO2. All comparisons will be made using Student's t-test with a Bonferroni correction. The number of study patients was chosen on the basis of a power analysis to provide an alpha of 0.05 at a level of 0.9.

Eligibility Criteria:
Inclusion Criteria:

* FEV1 \< 65% of predicted and FEV1 to FVC ratio \< 70%
* Baseline PAO2 while stable between 60-75 mmHg and
* The ability to provide informed consent

Exclusion Criteria:

* Clinical instability as evidenced by an acute exacerbation requiring an intensification of therapy and/or the need for hospitalization with the preceding 3 months.
* Presence of an additional cause of lung disease as suggested by history, clinical or radiographic findings, or pulmonary function tests
* Presence of left ventricular dysfunction and/or left atrial enlargement by echo, ECHO or catheterization
* Heparin allergy
* Pregnancy or breast feeding
A Phase II Study of Paclitaxel, UFT, and Leucovorin in Patients With Metastatic Esophageal Cancer

This study is for patients with esophageal cancer that has spread to other areas. The purpose of this study is to:

1. Determine how well a combination of taxol, UFT, and leucovorin work in these patients,
2. Determine the survival of patients with metastatic esophageal carcinoma treated with this combination of drugs.
3. Identify the side effects of this drug combination.


Eligibility Criteria:
INCLUSION

* Histologic proof of esophageal cancer
* No more than one prior non-taxane chemotherapy regimen for either treatment of localized disease or metastatic disease AND they may not have received a regimen containing low dose continuous infusion of 5-FU (i.e. \>5 days of infusion/cycle), capecitabine or UFT
* No prior therapy with UFT+/-leucovorin, a taxane, capecitabine, low dose continuous infusion of 5-FU or ethynyl uracil.
* Radiographic or physical examination documentation of metastatic disease
* No major surgery within the 2 weeks preceding the start of treatment and fully recovered from any complications of surgery
* No radiation within 2 weeks of beginning chemotherapy.
* No chemotherapy within 4 weeks of beginning treatment.
* Patients must wait at least 6 weeks after receiving BCNU or Mitomycin-C.
* Minimum life expectancy of 3 months
* Informed consent given
* Laboratory values within limits set by study.

EXCLUSION

* More than one prior chemotherapy regimen for metastatic disease
* Current serious medical or psychiatric illness that would prevent informed consent or intensive treatment
* \>grade 1 peripheral sensory or motor neuropathy
* Pregnant
* Patient is taking the drug Sorivudine
A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment

This is a multi-center, randomized, double-blind, placebo-controlled, Phase IV trial to evaluate the efficacy and safety of Choline Alfoscerate compared to placebo in patients with degenerative mild cognitive impairment.

Subjects will be randomised in a 1:1 ratio to receive either Choline Alfoscerate or its placebo. Investigational Products(IP, Choline Alfoscerate or its placebo) will be administered 3 times a day per oral during the treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 55 years
2. Diagnosis of mild cognitive impairment due to Alzheimer's disease that meets NIA-AA criteria
3. Diagnosed with mild cognitive impairment on SNSB
4. Delayed recall score of SVLT ≤ "average -1.5 standard deviation"
5. K-MMSE-2 score ≥ 24
6. The CDR score 0.5, and the memory item score 0.5 or 1 point
7. Patients with caregivers who are in regular contact, can visit together
8. Walk or move using walking aids (i.e., walkers, walking sticks or wheelchairs)
9. Sufficient vision, hearing, language skills, motor skills, and understanding to follow the examination procedure.
10. Written informed consent

Exclusion Criteria:

1. Diagnosis of dementia (including secondary dementia due to Alzheimer's disease, vascular dementia, infections of the central nervous system (e.g., HIV, syphilis, Creutzfeld-Jacob disease), Pixie disease, Huntington's disease, Parkinson's disease, etc.)
2. Medication of dementia within the past three months
3. Brain functional improvement medication in the past six weeks.
4. Medication that may affect cognitive function during clinical trials
5. No studies (no regular school entrance), illiteracy
6. Significant neurological conditions (such as stroke, multiple sclerosis, severe head trauma with loss of consciousness, cerebral palsy, cerebral tumor, cerebral infarction, spinal infarction or central nervous system infection) and/or evidence (CT or MRI results performed within the past 12 months or during screening)
7. Abnormal results from Vitamin B12, Thyroid Stimulated Hormone Test (TSH), HIV-Ab, and VDRL test contribute to or contribute to cognitive impairment of the subject
8. Serious mental disorders such as severe depression, schizophrenia, alcoholism, drug dependence, etc.
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 4 of 4)

The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.

A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenously administered PRT064445 after dosing to steady state with one of four direct/indirect factor Xa (fXa) inhibitors in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women between the ages of 18 and 45 years old

Exclusion Criteria:

* History (including family history) or symptoms of, or risk factors for bleeding
* History (including family history) of or risk factors for a hypercoagulable or thrombotic condition
* Absolute/relative contraindication to anticoagulation or treatment with specific anticoagulants
* History of major surgery, severe trauma or bone fracture within 3 months prior to dosing; or planned surgery within 1 month after dosing
Reducing Intracranial atheroSclErosis With Repatha

The purpose of this study will be to understand the underlying mechanism by which PCSK9 inhibition reduces the rate of ischemic stroke seen in the pivotal studies that led to its FDA approval for ASCVD such as ischemic stroke. Those trials (FOURIER and ODYSSEY) enrolled almost 50,000 patients and showed that PCSK9 inhibition therapy is safe and effective. The investigators hypothesize that PCSK9 inhibition lowers the rate of stroke by reducing atherosclerotic plaque, which would be particularly beneficial for patients with intracranial atherosclerosis, who have the highest rate of recurrent stroke of any stroke mechanism.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, ≥ 18 years of age
* History of ischemic stroke, defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction (American Heart Association definition).
* Large vessel atherosclerosis of an intracranial artery in the circle of Willis with 50-99% stenosis by WASID criteria (percent stenosis = (1-\[diameter stenosis/diameter normal\]) x 100%) on MRA, CTA or DSA

  ------ Eligible arteries: vertebral (V4), basilar, PCA (P1, P2), MCA (M1, M2), tICA, ACA (A1)
* Current statin use or contraindication to statin
* Fasting LDL-C ≥ 70 mg/dL or LDL-C ≥ 60 mg/dL if lipoprotein (a) \> 30 mg/ dL

Exclusion Criteria:

Gadolinium or PCSK9 inhibitor allergy

* Acute or chronic kidney disease with eGFR\<30 ml/min/1.73m2
* Pacemaker or other MRI contraindications per American College of Radiology guidelines
* Inability to return for 78 week follow-up clinic visit and vwMRI
Chronic Total Occlusion Registry

This study evaluated the long-term outcome of patients with chronic total occlusion treated with percutaneous coronary intervention, medical treatment or coronary artery bypass grafting.

This study is connected with Decision-CTO trial(NCT01078051). Randomized subjects and registry group subjects from Decision-CTO trial continue 10 years follow-up on this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with angina or silent ischemia and documented ischemia
* Patients with De novo chronic coronary occlusion ≥ 3months and reference diameter ≥ 2.5 mm on coronary angiography
* Age \> 18 years

Exclusion Criteria:

* Refuse to participate in this study
Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery

The aim of this study is to prove that using a CytoSorb(TM) filter in the cardiopulmonary circuit attenuates the inflammatory response to extracorporeal circulation in patients undergoing cardiac surgery. The hypothesis is that removing cytokines from patients' blood by the CytoSorb device significantly improves circulation and outcome in patients undergoing on-pump cardiac surgery.

Cardiac surgery with cardiopulmonary bypass (CPB) induces an inflammatory response due to contact of patients' blood with foreign surfaces like tubes or the oxygenator, ischemic-reperfusion injury and surgical trauma. Inflammation is modulated by cytokines, especially, interleukins. The extent of cytokine release is further related to the duration of bypass and the amount of operating field suction. This results in a systemic inflammatory response syndrome (SIRS) with the risk of multiple organ dysfunction (MOD). Also in patients treated with extracorporeal membrane oxygenation (ECMO) an activation of the inflammation system is seen and accompanied with an increase of cytokine levels. The cytokine concentration correlates with the severity of the immune reaction and can be a predictor of the outcome of the patient. As severe SIRS and MOD significantly increase mortality, the attenuation of the inflammatory response is supposed to reduce morbidity and mortality after cardiac surgery.

For adult cardiac surgery and patients who are treated with an extracorporal assist device, a tool for cytokine elimination and attenuation of the inflammatory response seems to be beneficial.

In our study we are going to investigate if the use of the CytoSorb device can improve the outcome of patients undergoing elective coronar artery bypass and heart valve surgery.

Eligibility Criteria:
Inclusion Criteria:

* undergoing elective coronar bypass AND heart valve surgery
* expected duration of bypass more than 120 min

Exclusion Criteria:

* age under 18 years of age
* pregnancy
* medication that interacts with the immune system (e.g. steroids, immune suppressors)
* patients with diagnosed immunodeficiency (e.g. HIV/AIDS)
* heparin induced thrombocytopenia type II
* patients that decline participation
High Resolution Thermal Imaging to Identify Vertebral Fractures in Children and Young People With Osteogenesis Imperfecta

Brittle bone disease also known as osteogenesis imperfecta (OI) is characterised by a defect in the bone tissue that leads to recurrent fractures and significant bone deformities in children. These fractures include vertebral (spinal) fractures. As a result, child with OI require regular clinic surveillance that includes repeated xrays of the spine. in our pilot study the investigators plan to use a thermal imaging camera that can pick up changes in temperature to 0.03 degrees to determine whether the investigators can accurately identify vertebral fractures without the need for radiation. in the first part of the study the investigators will compare the thermal images from the camera with the xrays to see if the investigators can pick up the vertebral fractures seen on the xray picture. If this is possible, then the investigators will move on to phase 2 of the study which will investigate the ability of the thermal camera to pick up vertebral fractures without prior knowledge of where the fractures are located. If this approach is successful this will help us to develop a nonradiation, lowcost painless way of identifying vertebral fractures in children with OI.


Eligibility Criteria:
* Patients with Osteogenesis Imperfecta (with known vertebral fractures)for phase one of the study.
* Patients with Osteogenesis Imperfecta for phase 2 of the study
* In both groups patients will be aged 5 years and over
The Significance of MRI in the Development of Diagnostics and Treatment of Breast Cancer

The purpose of this study is to determine how MRI changes the treatment and diagnostics of ductal breast cancer. 100 women with newly diagnosed breast cancer will participate the study.


Eligibility Criteria:
Inclusion Criteria:

* Tumor size less than 2cm
* Ductal carcinoma unifocal

Exclusion Criteria:

* Previous breast cancer
Efficacy and Safety of Plasma Exchange Compared to Standard Medical Therapy in Patients With Severe Drug Induced Liver Injury With or Without Underlying Chronic Liver Disease.

In this randomized study subject will be randomized into two groups Group A will receive Standard Medical Treatment (Albumin + High Caloric Diet) Group B will continue Standard Medical Treatment with High Volume Plasma Exchange. All other interventions will be at the discretion of clinicians.


Eligibility Criteria:
Inclusion Criteria:

* Age-18-70 years
* Preferably Biopsy proven or history suggestive of DILI (Drug Induced Liver Injury)

  1. Grade IV DILI With T.B \> 15
  2. DILI Manifesting as ACLF (Acute on chronic Liver failure) /ALF (Acute Liver Failure) with no transplant option

Exclusion Criteria:

* Evidence of active infection
* Refusal of consent or assent
* Patients with clinical suspicion of irreversible brain injury
* Pregnancy
* HCC (Hepatocellular Carcinoma) or any other malignancy
* Kidney failure
* Portal vein thrombosis
* Upper GastroIntestinal bleed
* Transplant