cyrilzakka/clinical-trials huggingface dataset:
CLDN6/GPC3/Mesothelin/AXL-CAR-NK Cell Therapy for Advanced Solid Tumors

This study is an open, exploratory clinical study to evaluate the safety and preliminary efficacy of Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells in patients with Claudin6, GPC3, Mesothelin, or AXL-positive advanced solid tumors (ovarian cancer and others)

1. Choose appropriate advanced cancer patients with Claudin6, GPC3, Mesothelin, or AXL expression, with written consent for the study;
2. Perform PBMCs apheresis from the patient and isolate NK cells, transfect the NK cells with Claudin6, GPC3, Mesothelin, or AXL targeting CAR, amplify the number of transfected NK cells as needed, test the quality and killing activity of the Claudin6, GPC3, Mesothelin, or AXL-CAR-NK cells and then transplant back the patients via systemic or local infusions (via artery or intra-tumor), and follow up closely to collect related results as needed;
3. To enhance the killing capability, some CAR-NK cells are genetically engineered to express and secret IL7/CCL19 and/or SCFVs against PD1/CTLA4/Lag3; some CAR-NK cells are combined with Cannabidiol(CBD) or Nicotinamide adenine dinucleotide (NAD);
4. Evaluate the clinical results as needed.
5. Will also perform the similar clinical trial on different cancer types with Claudin6, GPC3, Mesothelin, or AXL expression.

Eligibility Criteria:
Inclusion Criteria:

1. patients with advanced ovarian cancer or other cancers with expression of claudin6.
2. Life expectancy \>12 weeks
3. Adequate heart,lung,liver,kidney function
4. Available autologous transduced NK cells with greater than or equal to 20% expression of Claudin6, GPC3, Mesothelin, or AXL-CAR determined by flow-cytometry and killing of claudin6-positive targets greater than or equal to 20% in cytotoxicity assay
5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. -

Exclusion Criteria:

1. Had accepted gene therapy before;
2. Tumor size more than 25cm;
3. Severe virus infection such as HBV,HCV,HIV,et al
4. Known HIV positivity
5. History of liver/renal transplantation
6. Active infectious disease related to bacteria, virus,fungi,et al
7. Other severe diseases that the investigators consider not appropriate;
8. Pregnant or lactating women
9. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
10. Other conditions that the investigators consider not appropriate. -
Deciphering the Role of Oxytocin in Motivation: an fMRI Study

The proposed study will investigate the effects of intranasal oxytocin administration on neural activity associated with social and non-social motivation.

Oxytocin is a well-known social and reproductive hormone demonstrated to have a variety of prosocial effects in humans including enhancing trust and generosity, improving positive communication, increasing eye gaze, and reducing anxiety. Oxytocin is hypothesized to facilitate social behaviors via its modulation of motivational networks. With this study, we will characterize oxytocin's effects on the neural processing of salient stimuli. We will utilize a noninvasive brain imaging technique, functional magnetic resonance imaging (fMRI), to assess brain activity while participants perform tests designed to engage neural circuits associated with the processing of social and non-social stimuli.

Eligibility Criteria:
Inclusion Criteria:

* Male
* 20-35 years of age at the time of screening
* Right-handedness
* Non-smoking
* No current or past history of neurological or psychiatric illness, including substance abuse or dependence
* No acute medical illness
* Written informed consent obtained from subject

Exclusion Criteria:

* Female
* Left-handedness or ambidextrous
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
* Known allergies to oxytocin or to preservatives in the nasal spray
* Participants who exhibit nasal obstruction or upper-respiratory tract infection at the time of scanning or report the use of intranasally administered medications for up to two weeks prior to screening
* Participants unable to tolerate the scanning procedures or would be unfit for scanning purposes (e.g. metal implants, claustrophobic, unable to lie still for the duration of the scan)
* Any current or past history of medical, neurological, or psychiatric illness or family history of psychiatric or neurologic disease in first-degree relatives
* Neurological illness, abnormal MRI (except if due to technical factors)
* Acute or uncorrected medical illnesses, including history of hepatic or renal dysfunction.
* Participants currently taking medications including any treatment, current or past with antipsychotics, mood stabilizers, isoniazid, glucocorticoids, psychostimulants and psychostimulant appetite suppressants, or centrally active antihypertensive drugs (e.g., clonidine, reserpine).
* Treatment within six months with any of the following: hormone use (testosterone, DHEA), antidepressants, opioid drugs.
* Treatment within one month with sedative hypnotic medications (benzodiazepines, barbiturates), or over the counter sleeping aids
* Current or past history of substance abuse or dependence
* Any reported lifetime use of any category of illicit drugs
* Positive urine drug screen
Pharmacokinetics of Lenalidomide (Revlimid®) in Patients With Multiple Myeloma and Impaired Renal Function

The purpose of this study is to determine the pharmacokinetic profile of Revlimid® in patients presenting with Multiple Myeloma and impaired renal function, the safety of Revlimid® in the enrolled patients population.

and evaluate the efficacy of Revlimid®-Dexamethasone combination in patients presenting MM and impaired renal function at completion of 3 cycles of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of relapsed or refractory multiple myeloma (MM).
* Age \> 18 years at the time of signing the informed consent form
* Stable renal function

Exclusion Criteria:

* Documented amyloidosis
* Any prior use of Revlimid ®
* Any contraindication to Revlimid ® and especially:
* Lack of acceptable method of birth control for female of childbearing potential (FCPB)

  * Men who don't agree to use condom during the study and 4 weeks after the last study drug intake if their partner is a FCPB.
  * Pregnant or breast feeding women
Podiatry Intervention to Reduce Falls in Elderly Care Trial (PIRFECT)

This is an exploratory pilot Randomised Controlled Trial (RCT) to investigate the effects of a multifaceted podiatry intervention designed to reduce falls in care homes. The investigators hypothesise that the intervention will reduce the high falls rates present in care homes for older people, compared to usual care.

The results will inform the sample size calculation for a full-scale definitive RCT

Background: Falls are a problem in care homes where it is estimated that half of all residents will fall at least once in a year. There is now strong empirical evidence that weakness of the foot muscles and painful foot problems such as corns and/or callus are a contributing factor to falls in this population. These problems are common and reversible; however there have been no trials of podiatry interventions that address these problems to establish whether or not this approach can be effective at reducing falls in care home populations.

Methods: Care home residents meeting the inclusion criteria will be assigned to receive either the intervention (specific foot and ankle exercises, orthoses, footwear). We will then conduct an exploratory randomised controlled trial (RCT) with the aim of acquiring data that will inform the design of a subsequent full scale RCT. The groups will then be compared on a number of balance and falls related outcomes.

Main Outcome: The results will indicate the effect size to allow a sample size calculation for a later definitive trial to be conducted.

Eligibility Criteria:
Inclusion Criteria:

* 65 Years or older permanently living in care homes for older people
* One or more falls in the previous year.
* Foot problem that is within the scope of podiatry care

Exclusion Criteria:

* Residents who are terminally unwell or too frail to be included
* Residents who are only able to mobilise with the use of a wheelchair
* Temporary residents (for example, those in respite care)
* Unable to provide informed consent
* Lower limb Amputees
Virtual Reality and tACS for Performance Enhancement

The chronic stress of police work may reduce human performance through increases in anxiety, depression, pain, and insomnia. Land's End VR may teach mindful meditation that is associated with reduced anxiety, depression, pain, and insomnia. tACS may produce similar effects to Selective Serotonin Reuptake Inhibitors (SSRIs) without the side effect risks of SSRIs by stimulating neurotransmitter production and modulating the default mode network, resulting in reduced anxiety, depression, pain, and insomnia. These two technologies have not been investigated as interventions among police officers. Therefore, we propose a pilot randomized waitlist-controlled crossover trial of the feasibility and efficacy of Land's End VR and tACS among police officers.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* English-Speaking (The measures have not been validated in other languages).
* Willing and able to provide informed consent and participate in the study visit and study follow-up questionnaires
* Able to position head completely upright (90 degrees from the ground) in order to view the entirety of the Virtual Reality video

Exclusion Criteria:

* Hearing or visually impaired where they cannot use the Samsung Gear VR
* History of motion sickness or cyber sickness and unwilling to watch a 10-minute virtual reality video because of it
* Unable to position head completely upright (90 degrees from the ground)
* History of seizures
* Lesions, rashes, or open wounds on face, head, neck, or ears
* Medical device implanted in the head or neck
* Participants with pacemakers
* Participants with known or suspected heart disease
Impact of Providing Free Preventive Dental Health Products on Infant's Tooth Brushing and Bottle-feeding Termination Practices

Governmental initiatives (such as Sure Start in the UK) have integrated an oral health promotion intervention within their maternal and child health program and delivered dental education and enabling resources (a gift bag including a baby toothbrush, fluoride toothpaste and a trainer cup) to infant's mothers. Whilst this approach has minimal financial implications of human resources, no evidence exists regarding its effectiveness in establishing desirable infant's oral health behaviours. In Syria, there is a great need for developing an infant's oral health promotion program to promote oral hygiene practice, provide access to fluoride and terminate bottle-feeding practice. Thus, the current study aimed to test the effectiveness of an integrated infant's oral health promotion intervention within the Syrian national immunization program, which delivered printed dental education materials, a baby tooth brush, fluoride toothpaste (1000 ppm) and a trainer cup, in establishing one-year old infant's oral hygiene and bottle-feeing termination practices.

The current randomized controlled trail allocated 92 one-year old infants, attending a maternal and child health center in Sweida city-Syria, to receive their vaccination, into three groups: test, control 1 and control 2. The test group received an infant oral health promotion package including a child oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup. Control 1 received only an infant pamphlet, whilst Control 2 received no intervention. A mother's self-completed structured questionnaire and an infant's clinical examination were completed and performed, at baseline and after one month, to assess tooth brushing and bottle-feeding practices as well as the presence of old plaque on infant's primary teeth, respectively.

Eligibility Criteria:
Inclusion Criteria for infants:

* Healthy
* Single (not twins).
* Full-term (≥37 weeks).
* Birth weight ≥ 2500 g.
* Family size ≤3 children (including the infant).
* Their first tooth erupted.
* No reported tooth brushing practice.
Us vs Fluoroscopic Guided Renal Access

this present study is to compare the result of fluoroscopy, ultrasonography (US) in the guidance of percutaneous nephrostomy pcn .

investigators will enroll 100 patients who are candidates for PCN in the study. By simple random sampling technique, patients will be assigned to two patient groups (group 1, US-guided approach , group 2, fluoroscopy-guided approach.The end point of the study is the comparison of outcome of procedure including stone free rate, transfusion rate, operation time, access time, length of stay and complications.

Eligibility Criteria:
Inclusion Criteria:

* infected hydronephrotic kidney onen's grade 2-3
* obstructed good cortex with backpressure changes onen's grade 2-3 .
* Evaluation of function of asymptomatic hydronephrotic kidney thin cortex onen's grade 4

Exclusion Criteria:

* congenital anomalies of kidney
* patient underwent transplant or urinary diversion
* solitary kidney
Recurrent S. Aureus Infections in Osteoarticular Infections

Staphylococcus aureus osteoarticular infections, in particular those associated with the presence of implant, relapse in 20% of cases. Currently, the reasons for these relapses are poorly understood, whether on the microbiological or clinical side.

The aim of this study is to improve knowledge on persistence of mechanisms of S. aureus


Eligibility Criteria:
Inclusion Criteria:

* patients having had an osteoarticular infection with or without material due to S. aureus presenting a recurrence of S. aureus infection

Exclusion Criteria:

-
Prochlorperazine vs Metoclopramide

Migraine headaches are a common reason for patients to present to an emergency department. We are comparing two different medications to see which one is better for patients who present ot an emergency room with a migraine headache.

One-third of the five million headache patients who present to US Emergency Departments (ED) annually have a migraine headache. The anti-emetic dopamine receptor antagonists have proven efficacy for migraines, are at least as well-tolerated as triptans, and enjoy wide-spread use in North American EDs. However, it is not yet clear which medication within this class and which dosage is optimal. Therefore, we propose a randomized clinical trial to compare the efficacy and tolerability of two standard medications for migraine.

Specific Aim: To compare the efficacy of metoclopramide versus prochlorperazine for the emergency department treatment of migraine headaches. Both of these medications will be combined with diphenhydramine to prevent extra-pyramidal side effects.

Patients will be enrolled as participants if they present to one of the participating EDs and consent to participate. Medications will be administered as an intravenous drip over 15 minutes. Rescue medication will be administered, if needed, after one hour. A follow-up phone call will be conducted 24 hours after the ED visit.

Eligibility Criteria:
Inclusion Criteria:

* Present to the Ed with an acute migraine headache

Exclusion Criteria:

* secondary headache
* if the patient is to receive a lumbar puncture in the ED
* maximum temperature greater than 100.3 degrees
* new objective neurologic abnormality at the time of physical exam
* allergy or intolerance to a study medication
* pregnancy
* previous enrollment
miRNAs Profiling in Parkinson's Disease

microRNAs (miRNAs) regulate fundamental cell processes. Dysregulation of miRNA expression and function is reported in various diseases including cancer, metabolic disorders as well as neurological disorders. Circulating miRNAs have been proposed to mirror physiological and pathological conditions suggesting their use as biomarkers for various diseases. The study will focus on a case-control study cohort (N=1000) of subjects recruited at the IRCCS Neuromed for which a deep clinical characterization and genome-wide sequencing data are available. This study will enable to identify novel circulating biomarkers for Parkinson's disease (PD). Further, the project will give new insights on the involvement of miRNAs in the etiology of PD and in the understanding of the genetics of the disease thus opening avenues for novel therapeutic strategies.

Hypothesis and Significance:

The project intends to identify novel biomarkers for PD and clinical parameters related to the PD etiology. To do that circulating miRNA profiling through a next-generation sequencing will be performed using a single sample approach in the case-control study cohort and identified miRNAs will be validated by qRT-PCR and functional analyses. In addition, the project will contribute expanding the knowledge of the genetic architecture of PD taking advantage of genetic characterization of the study sample. miRNA genes and target genes will be used to prioritize genetic variants to be tested for association with PD to detect novel genes and functional variants that confer disease risk.

Specific Aim 1:

Profile of circulating miRNAs in the serum of PD patients and controls by next-generation sequencing in individual samples. Correlation between identified miRNAs and PD-related parameters and validation in independent cohorts

Specific Aim 2:

Bioinformatics prediction of target genes and miRNA functional validation

Specific Aim 3:

Identification of genes/genetic variants in miRNA pathways predisposing to PD

Expected outcomes:

The study will allow to discover novel circulating miRNAs as biomarkers for Parkinson's disease. As the deep phenotype characterization of the study sample, the project expects to find new associations of identified miRNAs with disease-related parameters and define the role of miRNAs in the physiological pathways in which those parameters are involved and in the etiology of PD. Also, the understanding of the genetics of the disease will open avenues for novel therapeutic strategies.

Eligibility Criteria:
Inclusion Criteria for cases:

* Presence of at least two out the following cardinal signs: resting tremor, cogwheel rigidity, bradykinesia, asymmetrical onset of symptoms and symptomatic response to L-dopa (levodopa)

Exclusion Criteria for cases:

* Previous thalamotomy on the implanted sided, significant brain atrophy or structural damage seen on CT or MRI, marked cognitive dysfunction, active psychiatric symptoms, or concurrent neurological or other uncontrolled medical disorders.

Exclusion Criteria for controls:

Personal or family history for neurodegenerative diseases
Study to Evaluate the Safety, PK, and Pharmacodynamics of LIB003

Randomized, double-blind, placebo-controlled, single ascending dose study in nine (9) separate and sequential dose cohorts (7 SC and 2 IV cohorts) to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of LIB003 in subjects with moderately elevated LDL-C levels.

After meeting eligibility criteria within each cohort subjects will be randomized to receive a single dose of LIB003. Seven (7) cohorts will receive LIB003 escalating doses of LIB003, or placebo, by SC injection and 2 cohorts LIB003 or placebo by IV infusion. Dose escalation will be based on the assessment of safety and tolerability data. All cohorts will each first enroll a sentinel group of subjects who will receive LIB003 or placebo in a double-blind fashion with the remaining subjects in that cohort only to be dosed after the safety data on day 4 from the sentinel subjects has been assessed and deemed safe.

Eligibility Criteria:
Inclusion Criteria:

* Men and women who are \>/=18 and \</=70 years of age. Female subjects must be of non-childbearing potential.
* LDL-C \>/=100 mg/dL who are either not on a lipid-lowering therapy or who are on stable statin therapy.
* Body mass index (BMI) \>18 and \<38 kg/m2
* Mild hypertensives on a stable dose of no more than one antihypertensive drug

Exclusion Criteria:

* History of any prior or concomitant clinical condition or acute and/or unstable systemic disease compromising subject inclusion
* Systolic blood pressure \<90 mmHg or \>160 mmHg or diastolic blood pressure \<50 or \>100 mmHg at screening
* Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C virus antibody
* Abnormal liver function test at Screening (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \>2 × the upper limit of normal \[ULN\]
* Estimated glomerular filtration rate \<60 mL/min/1.73 m2 at screening, as determined by the CKD-EPI Equation
* History of prescription drug abuse, illicit drug use (including marijuana), or alcohol abuse
* Unable to spend 4 days in confinement unit
* History of allergy to protein-based biologics including, but not limited to, mAbs and vaccine
* Any other finding which, in the opinion of the Investigator, would compromise the subject's safety or participation in the study
Evaluation of States in Major Depressive Patients With Cancer, Hospitalized in a Hospital Palliative

The investigators propose a study that aims to develop a methodology for assessing this risk and the psychological consequences of the malignancy in the palliative phase.


Eligibility Criteria:
Inclusion Criteria:

* Patient (s) age (s) 18 or more
* Patient (s) reach (s) of a cancer palliative stage
* Patient (s) hospital (s) in the palliative care service
* Patient (s) with cognitive function to an interrogation
* Patient (s) having a physical condition for an interview lasting 45 minutes
* Patient (s) that received clear information on the diagnosis and prognosis of their disease.
* Free and informed consent signed

Exclusion Criteria:

* Patient (s) age (s) under 18 years
* Patient (s) under supervision or unable to give informed consent
* Patient (s) whose cognitive functions do not allow an examination.
Total Xenoestrogen Body Burden in Relation to Mammographic Density, a Marker of Breast Cancer Rlisk

Mammographic density is sensitive to estorgen exposure and constitutes a strong intermediate maker of breast cancer risk. We hypothesize that women with higher serum xenoestrogen levels will have greater mammographic density.


Eligibility Criteria:
Inclusion Criteria:

* 55-70 years of age, Post menopausal

Exclusion Criteria:

* If they have ever used hormone replacment therapy or have ever used Tamoxifen or Raloxifene, Diag. with breast cancer have had breast implants or have had a mastectomy/
Investigation of Potential Retinal Toxicity Associated With Hair Dye Products Containing pPD Type Aromatic Amines

Hair dye products could induce minimal forms of MEKAR retinopathies (Mitogen-activated Extracellular signal-regulated Kinase - inhibitors associated retinopathies). These minimal forms of MEKAR are likely to be underdiagnosed, since the associated visual loss is usually mild and so this condition should be considered when patients report blurred vision. The aim of the study is to analyze whether in the current population that dyes the hair, minimal forms that go unnoticed by MEKAR retinopathies can be induced.


Eligibility Criteria:
Inclusion Criteria:

* Hair dye up to one month before the inclusion
* Hair dye product containing aromatic amines

Exclusion Criteria:

* Pregnant or lactating woman
* Retinal pathology already known, or central serous choroiditis