cyrilzakka/clinical-trials huggingface dataset:
Serum Neurofilament Light (NfL) as a Marker for Brain Injury in Individuals Undergoing Chimeric Antigen Receptor-modified T Therapy

The investigators propose that immune effector cell-associated neurotoxicity syndrome (ICANS) is predicated upon the early loss of blood brain barrier (BBB) integrity with subsequent monocyte infiltration leading to cross-activation of native glial cells. Glial overstimulation leads to neuroinflammation, synaptic dysfunction, and ultimately neuronal injury.


Eligibility Criteria:
Inclusion Criteria:

* Clinically scheduled to undergo treatment with tisagenlecleucel, axicabtagene ciloleucel, brexucabtagene autoleucel, or lisocabtagene maraleucel.
* At least 18 years of age.
* Able and willing to undergo study testing (blood draws, lumbar punctures, neuro-psychiatric testing, and neuroimaging with MRI)
* Participants of childbearing potential without documented history of menopause or hysterectomy who choose to participate must not be pregnant at screening and must agree to avoid becoming pregnant prior to scanning.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants unable to lie flat for the duration of the MRI scan).
* Contraindications to MR imaging (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate. Patients with pacemakers may only be scanned if approved by CCIR staff and radiology review.
* Severe claustrophobia.
* History of multiple sclerosis, Parkinson's disease, dementia (including Alzheimer's disease, frontotemporal dementia, and Pick's disease), or motor neuron disease including amyotrophic lateral sclerosis (ALS)
* For the lumbar puncture associated with the study only: contraindications to lumbar puncture (e.g. platelets \<r 50,000/mm3, INR \> 1.5, evidence of midline shift on imaging, presence of local infection at LP site, history of baclofen pump, history of significant spinal surgery/hardware which would preclude safe bedside lumbar puncture). If a contraindication to lumbar puncture develops while on study, patient may remain on study but will be barred from a lumbar puncture until that contraindication resolves.
* Pregnant
* Enrolled in an interventional study of a drug targeting neurotoxicity
Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses

This study evaluates novel surgical approach in treating small renal masses. Half of participants will undergo hypotonic zero-ischaemia partial nephrectomy (standard of care), while the other half will undergo normotonic zero-ischaemia partial nephrectomy (experimental method).

Partial nephrectomy is believed to be the gold standard for treating small renal masses (SRM). The warm ischaemia and hypotonic zero-ischaemia approach are widely used techniques of care. But they have some negative effects according to renal function (RF) after surgery. We decided to compare influence of arterial blood pressure (normotension or hypotension) during partial nephrectomy on RF.

A single-center prospective study comparing normotonic and hypotonic partial nephrectomy will be conducted.

The design involves random allocation of eligible patients to normotonic or hypotonic partial nephrectomy group in 1:1 ratio.

Experimental group - normotonic partial nephrectomy (avoidance of hypotension: mean blood pressure more or equal 65 mm Hg).

Control group - hypotonic partial nephrectomy (using medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg

According to preliminary calculations, taking into account type I error of 5% and power of 80%, 100 patients should be included in the study. In order to compensate for data loss, the estimated sample size is increased by 10%. As a result, the total sample size is 100 +10 = 110 patients (55 patients for each group). The expected duration of the study is 36 months.

Eligibility Criteria:
Inclusion Criteria:

* Suspected by computed tomography or another instrumental method renal mass
* Clinical stage T1-2N0-2M0-1 (distant metastases must be resectable)
* Indications for partial nephrectomy
* Eastern Cooperative Oncology Group status 0-2
* At least 18 years of age
* Written informed consent

Exclusion Criteria:

* Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol
* Pregnancy or breast feeding
* Medical contraindications for surgical treatment
* Synchronous or metachronous malignancy
* Non-resectable distant metastases
* The patient's refusal to perform research procedures.
* Refusal of the patient to continue participation in the study.
Alcohol Versus Chlorhexidine With and Without Water

Currently at NYU institutions, providine-iodine and chlorhexidine medicated soaps are available as hand disinfection options. The purpose of this study is to determine the relative efficacy of traditional hand scrubs with chlorhexidine with or without rinsing with water after scrubbing is complete versus dry hand rubs with alcohol.

No current recommendations exist advocating the use of Providine-iodine or Chlorhexidine. Providine-iodine is safe and effective at reducing skin colonization with gram positive and negative bacteria, mycobacterium tuberculosis, fungi and viruses. Chlorhexidine similarly disrupts cellular membranes. It is bacteriocidal and bacteriostatic and has immediate and more lasting effect than iodine because it can bind to the stratum corneum of the skin and is effective against gram positive and negative organisms, lipophilic viruses and yeasts.

All subjects who are employees of the NYU Hospital for Joint Diseases and have experience with surgical hand disinfection will be asked to enroll. Subjects will be randomized into one of three study arms using an online randomizer: (1) the standard chlorhexidine with water rinse, (2) chlorhexidine without water rinse(experimental), and (3) standard chlorhexidine followed by sterillium hand rub. After hand disinfection protocol has been completed, each subject will have each hand cultured three times using a cotton swab culture stick and sent to the microbiology lab for processing

Eligibility Criteria:
Inclusion Criteria:

* Orthopedic resident or surgical employee of NY U
* Over 21 years of age
* Procedural knowledge of correct aseptic scrub technique

Exclusion Criteria:

* No surgical experience
* Under 21 years of age
* Refusal to consent
Investigating the Effects of Beef Consumption on Cognitive and Brain Health

The goal of this study is to evaluate the effects of beef consumption on cognitive and brain health in healthy young adults. Specifically, we seek to evaluate the effects of beef consumption on measures of executive function, memory, psychological well-being, and sleep quality. Additionally, we will explore the effects of increased beef consumption on measures of brain health derived from structural and functional brain imaging.

All participants will take part in a 12-week dietary intervention study. Throughout the intervention, participants will receive 5 portions of ready-to-eat beef in frozen packages each week. Each serving of ready-to-eat beef for the experimental group will weigh 5-ounces, while each serving of ready-to-eat beef for the comparison group will weigh 1-ounce. Study compliance will be evaluated through weekly surveys about beef consumption.

In addition to completing the dietary intervention, participants will complete pre- and post-intervention assessments:

* MRI scan, including structural and functional brain imaging
* a comprehensive questionnaire battery evaluating cognitive and psychological measures
* neuropsychological tasks
* a blood draw


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
* Males and females; Age 19-24
* Willingness to adhere to the ready-to-eat beef intervention regimen
* Enrolled at University of Nebraska-Lincoln during the 2024 school year
* Score between 49 and 64 out of 100 on the Healthy Eating Index
* Consume less than or equal to 1 ounce of beef per day on average prior to participating in the study
* BMI between 18.5 and 39.9
* Not pregnant or nursing
* No history of cognitive or metabolic diseases indicated by diagnosis, including neurodegenerative disease, stroke, Type 1 and 2 diabetes, metabolic syndrome, cardiovascular disease, liver disease, kidney disease, and cancer
* No history of eating or anxiety disorders
* Low beef consumers, and be willing to adhere to the assigned ready-to-eat beef intervention regimen during the study
* Willing to discontinue dietary supplement use throughout the duration of the study, if they are consuming supplement at the time of the registration
* No known contraindication to MRI scans as determined by the MRI screening survey questions

Exclusion Criteria:

* Current use of medications that may affect their responses to dietary intervention, such as amphetamines, antidepressants, anti-diabetic medications, laxatives, antibiotics, statins and diuretics.
* Known intolerance or allergy to beef
* Current use of nicotine products, including vaping
* Previous use of nicotine products, including vaping, within the recent 6 months at the time of pre-screening
Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission

The study will compare the efficacy of the 2 treatments in intermediate and high-risk APL patients in achieving first hematological complete remission and molecular remission.


Eligibility Criteria:
Inclusion criteria:

1. Patients with untreated newly diagnosed and genetically proven APL (leukemic cells at diagnosis with the t(15;17) and/or the PML/RARα rearrangement by RT-PCR; the presence of additional cytogenetic lesions is not considered an exclusion criterion) with intermediate and high risk disease.
2. Male and female patients age \> 18 years and \< 61 years.

Exclusion criteria:

1. Low risk patients (WBC \< 10 x 109/L and platelets \> 40 x 109/L).
2. Absence of PML-RAR α rearrangement in leukemic cells after successful RNA extraction and amplification of control gene.
3. Pretreated APL.
Investigating the Relation Between Environmental Factors and Activity-participation in Children With Cerebral Palsy

Cerebral palsy (CP) is a chronic condition that causes the most childhood disabilities on worldwide. Impairment in movement and posture development seen in children with CP it causes difficulties in performing activities and affect in emotional, social, and cognitive abilities cause limited participation in everyday life. The ICF-CY child is divided into five categories: body structure and functions, activities, participation, environmental and personal factors, it is treated holistically. Initially, children with CP have adopted the view that environmental factors can also affect functionality, while focusing on the treatment of motor disorders to reduce activity and participation limitations in physiotherapy and rehabilitation applications. Environmental factors; the environment in which the child lives, his family, the devices he uses, health and care services, and government policies. These factors vary according to each country's own cultural and economic opportunities. The investigator planned to do this study because we found that there is a need for a comprehensive study of children with SP in Turkey, which does not reveal the relationship between environmental factors and activity and level of participation.

The study consist of two phases:

1. European Child Environment Questionnaire (ECEQ) will translate in to Turkish in the first phase.

   * Forvard translation (translate to Turkish from English)
   * Expert opinion (Turkish version will control by expert)
   * Back translation (Turkish version will translate to English)
   * Cultural adaptation Validity and reliability study will done
2. The relationship between environmental factors and activity and participation will be investigated in the second phase.

Eligibility Criteria

* 2-18 years old
* Cerebral palsy diagnosed
* Children or family who understand and speek Turkish language
* Children or family who know writing and reading
* Volunteer to join the study

Outcome Measures

1. Clinical classifications:

   Gross Motor Function Classification System (GMFCS) for classifying gross motor function levels Manuel ability classification system (MACS) for classifying fine motor function levels Communication Function Classification System (CFCS) for classifying communication function levels Eating Drinking Abilities Classsification System (EDACS) for classifying eating and drinking functions levels will be used
2. Activity evaluation:

   Gross Motor Function Measurement (GMFM) Pediatric Evaluation of Disabilty Inventory (PEDI) will be used
3. Participation:

   Life Habits Questionnaire (Life-H) will be used
4. Environmental factors:

European Child Environment Questionnaire (ECEQ) Impact on Family Scale (IPFAM) will be used

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed cerebral palsy
* Volunteer to join the study
* Know writing and reading
* speeking Turkish

Exclusion Criteria:

* Seconder neurologic impairment
* not complete the evaluation
The Optimal Leg Angulation of Femoral Central Catheterization in Pediatrics

Evaluation for the range of smallest leg angulation with femoral artery and vein overlap with femoral central catheterization in pediatrics.

In pediatrics, femoral vein catheterization often overlaps with the femoral artery.

In this case, the risk of artery puncture is high, vein collapse when artery puncture 2nd, 3rd times exceeds the success rate of catheterization becomes low. In previous study, comparing 0, 30, and 60 degrees with frog leg position, there was a study that the overlap was the smallest at 60 degrees. A previous study was a simple frog leg position and a study in fragmented predetermined angles. On a continuous measurement, we planned the study under the assumption that there is a more definite range of optimal angulation.

Ultrasound probe in the state of Inguinal crease, we find a part without bifurcation of femoral artery and femoral vein in frog leg position(external rotation + flexion increase). Increase the leg angle and check the vein and arterie relations.

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients younger than 3 years
2. ASA class 1-3
3. Patients scheduled for elective surgery.
4. If the patient's guardian can understand and write the contents of the agreement.

Exclusion Criteria:

1. A patient with previous history of dislocation of the hip.
2. Hip joints with limited hip movement.
3. A patient with vascular malformation of the femoral vein
4. Emergency surgery
5. Hemodynamic unstable patient
6. If the patient's guardian cannot understand and write the contents of the agreement.
Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis

The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.

The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12. Subjects were randomized ina 1:1:1:1:1 ratio. Subjects randomized to receive AMG 827 received 70, 140, or 210 mg at day 1 and weeks 4 and 8.

Eligibility Criteria:
Inclusion Criteria:

* Subject has had stable moderate to severe plaque psoriasis for at least 6 months
* Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
* Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.

Exclusion Criteria:

* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication-exacerbated psoriasis.
* Evidence of skin conditions at the time of the screening visit (eg, eczema, guttate psoriasis) that would interfere with evaluations of the effect of IP on psoriasis.
* Subject has any active CTCAE grade 2 or higher infection
* Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
* Subject has used the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids
* Subject has used the following therapies within 28 days of the first dose: Class I or II topical steroids, UVA therapy (with or without psoralen), or systemic psoriasis therapies
* Subject has used the following therapies within 3 months of the first dose: adalimumab, alefacept, etanercept, infliximab, certolizumab, or live vaccines
* Subject has used an anti-IL12/IL23 inhibitor within 6 months of the first dose
* Subject has previously used an anti-IL17 biologic therapy, efalizumab, or rituximab
Osimertinib Combined With Anlotinib in EGFR T790M Mutated NSCLC Patients With Progression on Osimertinib Treatment

EGFR T790M gatekeeper mutation accounts for approximately 60% of acquired resistance to the first- or second-generation EGFR-TKI treatment. Osimertinib, a third-generation EGFR TKI, has become the standard therapy for NSCLC patients with acquired EGFR T790M mutation. However, acquired resistance to osimertinib is still inevitable and there is no established targetable agent currently. Thus, treatment strategy for patients with acquire resistance to osimertinib remains an urgent issue. In this study, we aimed to evaluate the efficacy of osimertinib combined with anlotinib in acquired EGFR T790M mutated NSCLC patients with gradual progression on osimertinib treatment.

In current clinical practice, acquired resistance to osimertinib can be divided into three clinical modes: dramatic progression, gradual progression and local progression. For patients with gradual progression,there are various clinical explorations，including the continuation of osimertinib with chemotherapy or radiotherapy, osimertinib combined with antiangiogenic agents. In preclinical studies, an overactive vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) pathway and tumour angiogenesis plays a crucial role in the resistance to EGFR-TKIs, and the dual targeting of both the VEGF and EGFR pathways may prevent resistance.

Anlotinib (AL3818) is an inhibitor targeting multiple receptor tyrosine kinases involved in tumour progression, especially VEGFR 2/3, PDGFRα/β and c-Kit. We suppose that the combination treatment of osimertinib and anlotinib may ameliorate acquired resistance to osimertinib.This is a multi-center, open, single-arm, exploratory phase 2 trial evaluating osimertinib combined with anlotinib in acquired EGFR T790M mutated NSCLC patients with gradual progression on osimertinib treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide informed consent, complete all study assessments and have complete medical record.
2. Age:18-75 years.
3. Histologically or cytologically confirmed diagnosis of local advanced or metastatic NSCLC.
4. Patients should be confirmed acquired EGFR T790M mutation and received osimertinib as the second line treatment, and they should have the following: (1) benefit from treatment with osimertinib initially ;(2) gradual progression on osimertinib treatment as defined by minor increment of tumor burden (≥10% but \<20% in the sum of target lesions).
5. At least one measurable lesion as defined by lesions ≥10mm in long axis according to RECIST 1.1.

Exclusion Criteria:

1. Patients who will be or were involved in any other interventional antitumour clinical studies for locally advanced/metastatic NSCLC currently or previously.
2. Small cell lung cancer (including small lung cancer mixed with non-small cell lung cancer).
3. Patients at risk of bleeding.
4. Patients with renal dysfunction.
5. Uncontrolled severe hypertension.
6. Any concomitant condition evaluated by physicians which is not suitable for osimertinib or anlotinib treatment.
Docetaxel Versus Oxaliplatin as Addition to S-1 for Stage II / III Gastric Adenocarcinoma

S-1 plus oxaliplatin has been proved better than S-1 alone for stage II or III gastric cancer.

Docetaxel also showed excellent efficacy with S-1 in the postoperative setting for stage III gastric cancer.

This trial is designed to investigate the efficacy and safety of S-1 plus docetaxel versus S-1 plus oxalipltin as adjuvant chemotherapy after D2 resection in stage II / III gastric cancer.

In this study, patients with gastric or EGJ adenocarcinoma who received D2 dissection and staged II or III, aged from 18 to 75 years and with ECOG PS ≤2 and adequate organ function, are stratified randomized according to pstage and location of primary lesion.

Group DS:

S-1 is orally administer by BSA (\<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; \>1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.

Docetaxel 40mg/m2/3w from the second to the seventh cycles.

Group SOX:

S-1 is orally administer by BSA (\<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; \>1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.

Oxaliplatin 130mg/m2/3w from the first to the eight cycles.

The primary end point is disease-free survival(DFS). The overall survival (OS), safty and quality of life are secondary end points.

Eligibility Criteria:
Inclusion Criteria:

* informed consensus of patients
* be able to receive oral administration
* from 18 to 75 years old
* be proven to be primary adenocarcinoma of stomach and staged II or III by pathological evidences
* without other chemotherapy and/or radiation against to the disease
* normal function of other organs including heart,liver ,kidney and so on
* Eastern Cooperative Oncology Group performance status:0\~2

Exclusion Criteria:

* history of other malignancy
* allergic reaction to S-1 or oxaliplatin of docetaxel
* be enrolling in other clinical trials
* abnormal GI tract function
* dysfunction of other organs
* female in pregnancy or lactation,or refuse to receive Contraception measures during chemotherapy
* other situation to be judged not adaptive to the study by investigators