cyrilzakka/clinical-trials huggingface dataset:
Abraxane and RT for Non-Small Cell Lung Cancer (NSCLC)

For patients with stage III Lung Cancer, We propose one cycle chemotherapy using Abraxane and Carboplatin, followed by pulsed low-dose sensitizing Abraxane chemotherapy and daily Radiation. This will be followed by more hi-dose chemotherapy. We anticipate this regimen to target early distant microscopic spread by using one cycle of chemotherapy prior to radiation, and to achieve control of the disease in the lung by combining pulsed low-dose sensitizing Abraxane, with radiation.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed NSCLC.
* Clinical or pathologic stage IIIA (T1-3N2M0, T3N1M0) and IIIB (Any T N3M0, T4 Any N M0) diseases according to the American Joint Committee of Cancer criteria.
* Patients with malignant pleural effusion will be excluded.
* The primary tumor must be radiographically measurable.
* Age \> 18.
* Karnofsky performance status \> 70 or Zubrod PS 0 or 1.
* FEV1 sufficient for patients to tolerate radiation therapy, which is at the discretion of the radiation oncologist, usually \> 800 ml, but may be higher or lower depending on the volume of radiotherapy portal, which is a variable of the tumor extent.
* WBC \> 3000; platelet count \> 100,000; absolute neutrophil counts \> 1,500; HGB \> 9.0 g/dl, serum creatinine \< 1.5 mg/dl or creatinine clearance \> 60 ml/min. Laboratory values must be obtained \< 4 weeks prior to registration.
* Patients with equivocal enlargement of adrenal gland(s) on CT scan, or a few equivocal regional or distant lesions on any imaging studies need further imaging study (PET, bone scan, or others) or biopsy to rule out distant metastasis.
* Patients must have adequate liver functions: AST and ALT \< 2.5 x upper limit of normal, alkaline phosphatase \< 2.5 x upper limit of normal, unless bone metastasis is present in the absence of liver metastasis. Bilirubin \<1.5 mg/dL.
* Pre-existing neuropathy must not be worse than grade I.
* A signed informed consent.
* Normal organ function including EKG findings deemed acceptable for chemotherapy by the medical oncologist.

Exclusion Criteria:

* Patients with distant metastasis (stage IV disease).
* Patients without measurable disease.
* Patients with medical contraindication to chemotherapy or radiotherapy.
* Patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina, congestive heart failure, uncontrolled arrhythmia.
* Patients with bilirubin elevated above institutional upper limit of normal (ULN) must be excluded.
* Women who are pregnant or breastfeeding are not eligible.
* Other serious illnesses or medical conditions
Study of the Inflammatory Microenvironment in Atypical Meningiomas

Atypical meningiomas represent 15% of meningiomas. They present a high rate of recurrence, and therapeutic strategies are limited. There is a need for novel treatment strategies, such as immuotherapy.

This is a retrospective study including 84 patients with primary diagnosis of atypical meningiomas. The presence of T cells (CD4, CD8, Treg and memory T cells) and mature dendritic cells will be quantified on whole tissue sections stained by immunohistochemistry (CD4, CD8, FOXP3, CD45RO and CD208).

This could allow us to identify novel biomarkers for survival, and facilitate the selection of patients who may benefit from immunotherapeutic modalities.


Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of atypical meningioma
* surgery
Investigation of Gene Mutations in Patients With Triple-negative and Patients With HER2+ Breast Cancer Adenocarcinoma

The present study is a transnational study in patients with high risk recurrent breast cancer who receive adjuvant chemotherapy with epirubicin and cyclophosphamide followed by docetaxel or paclitaxel.

This will be a retrospective analysis of patients with histologically confirmed triple-negative or HER2+ operable breast cancer (with high risk of recurrence) who are treated at Hellenic Cooperative Oncology Group (HeCOG)- affiliated departments of oncology. Patients who participate are 18 years or older, women of any menopausal status with triple-negative or HER2+ breast cancer who receive epirubicin and cyclophosphamide every two weeks followed by docetaxel every three weeks or weekly paclitaxel. Patients with HER2-positive tumors are treated with trastuzumab, initiated concurrently with the first cycle of docetaxel, for 52 weeks. Pertuzumab may be combined with trastuzumab only in patients with node-positive disease.Patients can be treated with hormone therapy and/or radiotherapy. The investigation of the potential biomarkers will be performed using in situ methods in Formalin fixed paraffin embedded (FFPE) tumor sections. More specific will be investigated the expression of estrogen and progesterone receptors, the expression of SPARC proteins, special cellular activation and metastasis systems and other important pathways in cell life and reproduction.

Statistical analysis: The primary endpoint of the study will be the progression-free survival (PFS), defined as the time from treatment initiation to either the first documented disease progression or death from any cause. Second primary endpoint will be the overall survival (OS), defined as the time from treatment initiation to patient's death or last contact. Survival curves will be estimated using the Kaplan-Meier method and compared across groups with the log-rank test. The associations between the clinicopathological factors to be examined and the mortality rate will be evaluated with hazard ratios estimated with Cox proportional hazards model. The statistical analyses will be completed using the SAS software (SAS for Windows, version 9.3, SAS Institute Inc., Cary, NC).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Αny menopausal status is allowed
* triple-negative breast cancer
* HER2+ breast adenocarcinoma
* tumor size \<= 5 cm
* presence of operable axillary lymph nodes or the presence of clinicopathological parameters indicating an intermediate or high risk of recurrence without the presence of infiltrated lymph nodes
* Performance status (PS) = 0 or 1
* adequate bone marrow function , heart, liver and kidney
* no other history of previous neoplasm or other serious illness

Exclusion Criteria: -
Social Cognition and Personality Changes in Alzheimer's & Parkinson's Disease & Frontotemporal Lobar Degeneration

The aim of this study is to compare personality and social cognition changes, including emotion detection and self-awareness, and neuroanatomical correlates in patients, and how that affects the caregiver-patient relationship.

The purpose of this study is to understand social cognition changes in patients with Alzheimer's disease (AD), Parkinson's disease (PD), and Frontotemporal Lobar Degeneration (FTLD), which includes Progressive Supranuclear Palsy (PSP), Corticobasal Syndrome (CBS) and Frontotemporal Dementia (FTD - behavioural variant frontotemporal dementia, progressive non-fluent aphasia and semantic dementia), and the effect of these changes on the patients' relationship with their caregivers. In addition, the study aims to provide a greater clarity in the neuroanatomical correlates of social cognition in patients with FTLD, PD and AD.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* ability to speak and understand the English language (as questionnaires and tests are only available in English)

Caregivers:

* primary caregiver for a given patient
* ability to speak and understand the English language (as questionnaires and tests are only available in English)

Exclusion Criteria:

Patients and Caregivers:

* history of another neurological disorder
* psychiatric disorder
* severe aphasia (semantic word loss)
* visual deficits requiring correction beyond the use of eyeglasses or contact lenses (intact visual acuity is required for completing both the questionnaires and the emotion evaluation test which consists of video vignettes)
* auditory deficits requiring correction beyond hearing aids (videos have auditory component)

Patients:

* presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body will be excluded as they will be unable to have a MRI scan.
* premenopausal women will be excluded due to the unknown risk of MRIs during pregnancy.
Pilot Study Evaluating the Optimization of the ORBEYE Blue Light Filter During Fluorescence-Guided Resection of Gliomas

Fluorescence-guided resection using 5-ALA induced tumor fluorescence of malignant gliomas allows for better identification of tumor tissue and more radical resection in select patients and improvements in progression-free and overall survival. With new developments in surgical microscopy, the development of digital exoscopes have provided advanced visualization as well as improvements in ergonomics and accessibility of the surgical field. The use of the exoscope in 5-ALA fluorescence-guided tumor surgery has the potential to enhance the ability of the surgeon to remove brain tumors with high efficacy. While algorithms for use of 5-ALA fluorescence have been optimized for use with traditional microscopes, the use of fluorescence techniques in newer digital exoscopes have not been developed. The primary outcome of the study is to obtain parameters to optimize visualization of fluorescence intensity and perform optimization based on the intensities achieved. The operating ORBEYE exoscope will be fitted with a blue light filter. All experiments will be performed in darkened operating rooms. The ORBEYE exoscope will be set up at constant distances from the target and incident light intensities. The focal distance and light intensity settings will be recorded from the data displayed on the microscope. Patients (experimental group) will receive 5ALA treatment before operation, blue light filter imagining will take place after tacking up dura and prior to direct resection. The expected outcomes of image analysis will be to have a set of exoscope parameters optimized for visualization of 5ALA tissue in different tumor types. This 5ALA characterization of visualization parameters has never been completed on an exoscope. Optimizing ORBEYE exoscope parameters will define a standard in glioma resection using 5ALA under a novel exoscopic filter as well as contribute insight into the use of the fluorescent filter for additional tumor types.


Eligibility Criteria:
Inclusion Criteria:

* Male and female ≥ 18 years of age
* Must have a suspected or biopsy-proven glioma (World Health Organization grade II or IV), new or recurrent
* Indication for craniotomy for removal of a suspected or recurrent brain tumor
* Karnofsky Performance Scale ≥ 60%
* Willing and able to provide informed consent or have surrogate consent by legally authorized representative

Exclusion Criteria:

* Male and female \< 18 years of age
* Porphyria, hypersensitivity to porphyrins
* Renal insufficiency as defined by a creatinine \> 2.0 mg/dL
* Hepatic insufficiency as diagnosed in preoperative medical clearance evaluation
* Females of childbearing potential with a positive pregnancy test
* Nursing women
* Unwilling or unable to provide informed consent
The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation

This study aims to evaluate the efficacy and palatability of a developed polyethylene glycol-based formula compared with the standard polyethylene glycol (PEG) in the treatment of children with functional constipation for 8 weeks. Besides, we also aim to assess the side effects of a developed PEG-based formula as well as evaluate the change of rectal diameter from baseline at each visit between 2 groups.

Total 52 children age 6 months to 18 years old diagnosed with functional constipation will be enrolled in this study. They will be randomised in Group A or Group B.

Children in group A will receive PEG-Chula at a dose of 0.5 - 1 g/kg/day for a duration of 56 days.

Children in group B will receive the standard PEG formula (Forlax) at a dose of 0.5 - 1 g/kg/day for a duration of 56 days.

PEG-Chula and standard PEG will be prepared in sachets with similar packaging and appearance labelled A, B, C, D.

Children in both groups will also receive counseling on toilet training, water intake, and fiber intake in the same manner.

Parents will be advised to record symptoms, dietary intake, and dose of medication in a logbook.

Children will visit the researchers on days 7, 14, 28, and 56 to collect data on symptoms, stool diameter, bowel size measured by ultrasound, side effects, and medication compliance. Children with poor compliance will be excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

Children will be enrolled in this study when they meet 2 criteria:

* Age from 6 months to 18 years old
* Children are diagnosed with FC according to ROME IV criteria

Exclusion Criteria:

Children will be excluded from the study if they meet any of the following criteria:

* Having an organic cause of constipation such as anorectal malformations, Hirschsprung disease, myelomeningocele, hypothyroidism, etc.
* Suspected GI obstruction
* Receiving medication affecting bowel movement
* Having a history of allergy to PEG and stevia.
MENDiP: Measurements of Overnight Penile Temperature to Evaluate Nocturnal Erection Detection in Patients With Absence of Erectile Functioning After Robot-assisted Radical Prostatectomy

Nocturnal erection detection with the outdated RigiScan is the golden standard for erectile dysfunction (ED) nature differentiation. The Staying Hot and Feeling Hot study have shown that nocturnal erection detection is feasible with patient-friendly overnight penile temperature measurements. The question has arisen whether the penile temperature methodology is also capable to detect the absence of nocturnal erections, which is essential for clinical implementation in erectile dysfunction diagnostics. The objective of the MENDiP-study is to determine the feasibility to detect the absence of nocturnal erections with overnight penile temperature sensors. Furthermore, the MENDiP study functions as a first pilot trial to investigate the effect of age on the penile temperature during nocturnal erections in test subjects with normal erectile functioning. This is done in an observational study with a longitudinal design in which pre- and postoperative ambulatory overnight measurements are performed in patients, aged 55 - 70 years with preoperative normal sexual functioning, undergoing a non- or unilateral nerve-sparing robot assisted radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Preoperative measurement:

   * Aged 55 - 70 years
   * Prostatecancer patients undergoing a non-/unilateral-nerve-sparing radical prostatectomy (RARP)
   * Pre-operative IIEF-5 score \> 21
2. Postoperative measurement

   * Inclusion criteria of pre-operative measurement
   * Preoperative penile temperature increase during first nocturnal erection of minimally 0.4 degrees Celsius
   * Post-operative IIEF-5 score \< 12 with absence of morning erections

Exclusion Criteria:

* Test subjects who are unwilling to sign informed consent
* Test subjects with erectile dysfunction before RARP (IIEF-5 score of below 22)
* (History of) sickle cell aneamia, atherosclerosis and diabetes type I or II. These conditions might influence penile blood circulation and therefore the accuracy of the study outcomes.
* (History of) REM-sleep behavior disorder or other sleep disorders such as restless legs syndrome, insomnia, and sleep apnea
* Usage of sleeping pills or benzodiazepines.
* Postoperative results will be excluded from the study in case of presence of nocturnal erections according to the RigiScan data.
4-Point Therapy Response Score With PET/CT for Anal Squamous Cell Cancer

This study determines whether a positron emission tomography (PET)/computed tomography (CT) 4-point scoring system may predict overall survival for anal squamous cell cancer patients. A 4-point scoring system involving imaging scans may help to predict how patients with anal squamous cell cancer respond to chemoradiation therapy.

PRIMARY OBJECTIVE:

I. To determine whether a PET/CT scoring system in invasive biopsy proven anal squamous cell carcinoma (SCCA) to be treated with chemoradiation with curative intent (any T any N) predicts for overall survival (OS).

SECONDARY OBJECTIVES:

I. To determine whether a PET/CT scoring system in invasive biopsy proven SCCA to be treated with definitive chemoradiation with curative intent predicts for progression free survival (PFS).

II. To determine and validate inter-reader reliability. III. To calculate C-index to evaluate the prognostic capacity of PET/CT scores for survival.

IV. To determine the association between pre-treatment PET/CT scores after treatment and OS.

EXPLORATORY OBJECTIVE:

I. To correlate level of standardized uptake value (SUV) pre and post therapy and its correlation with overall survival.

OUTLINE:

Patients undergo PET/CT at baseline and at 3 months post therapy completion. Patients' medical records are received. Patients are followed up for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed biopsy proven invasive SCCA (any T, any N) deemed a candidate to undergo standard of care definitive chemoradiation at MD Anderson Cancer Center (MDACC) with curative intent
* Age \> 18 years at time of study entry
* Ability to provide written informed consent

Exclusion Criteria:

* Patients unwilling to participate in a PET/CT at baseline and at 3 months post completion of definitive chemoradiation
* Patients with an active second primary malignancy requiring chemotherapy or radiation treatment
* Stage IV SCCA
AMP Step Wedge Trial

Annually, more than 35 million patients are hospitalized in the United States. Many of these will experience hospital-acquired loss of physical functioning due to a lack of mobility during their in-patient stay. Such loss includes difficulties performing basic activities, such as rising from a chair, toileting, or ambulating. This loss of function may increase hospital length of stay (LOS), nursing home placement, and decrease mobility and participation in community activities even years after hospitalization. Prevention of this hospital-acquired functional loss is critical. Even the sickest hospitalized patients (e.g., those in the intensive care unit \[ICU\]), can safely and feasibly benefit from early mobilization. In the non-ICU setting there is evidence that patient mobilization reduces LOS and hospital costs, while improving patient satisfaction and physical and psychological outcomes. The overall objective of this proposed project is to evaluate the implementation and impact of a transdisciplinary and multifaceted mobility program (Johns Hopkins Activity and Mobility Promotion - AMP) on clinical outcomes among hospitalized adults. In addition to clinical outcomes, we will identify barriers and facilitators to high-performance program adoption. Results of this project will provide critical new insights on the effectiveness of AMP and inform dissemination and implementation nationwide.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients admitted to study hospital unit
* Analysis will only include those with lengths of stay \>=3 days

Exclusion Criteria:

* Patients with active do-not-resuscitate (DNR) order
* \<18 years old
Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis

The purpose of this study is to assess the feasibility, acceptability, and efficacy of self-administered transcranial direct current stimulation (tDCS) in older adults with knee osteoarthritis (OA)


Eligibility Criteria:
Inclusion Criteria:

* have symptomatic knee OA based on American College of Rheumatology Clinical criteria
* have had knee OA pain in the past 3 months with an average of at least 30 on a 0-100 NRS for pain
* can speak and read English
* have no plan to change medication regimens for pain throughout the trial

Exclusion Criteria:

* prosthetic knee replacement or nonarthroscopic surgery to the affected knee
* history of brain surgery, brain tumor, seizure, stroke or intracranial metal implantation
* systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia
* alcohol/substance abuse
* current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists
* diminished cognitive function that would interfere with understanding study procedures(i.e., Mini-Mental Status Exam score ≤ 23)
* pregnancy or lactation
* hospitalization within the preceding year for psychiatric illness
* no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision
Epidural Neuroplasty Using Racz Catheter During Lumbar Fixation in Situ for Lumbosacral Spondylolisthesis

This study aims to evaluate the analgesic efficacy of epidural neuroplasty using a Racz catheter during lumber fixation in situ for lumbosacral spondylolisthesis.

Lumbosacral spondylolisthesis, a common neurosurgical disorder, involves the anterior displacement of a vertebra in relation to the one below it. It often leads to back pain and neurologic symptoms.

Epidural lysis of adhesions is a procedure which treat chronic LBP in patients which didn't respond to medical treatments.The technique of Radiofrequency ablation (RFA) uses high-frequency current to produce tissue coagulation and heat. It involves the use of radio waves, applied through a percutaneous probe to generate heat and create a lesion in a spinal sensory nerve

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* Patients suffering from spondylolisthesis grade 0, 1, 2 complaining of low back pain and/or sciatica.

Exclusion Criteria:

* Uncooperative patients.
* Patients in need of discectomy for lumber disc prolapse.
* Patients with severe canal stenosis and in need of spinal laminectomy.
* Contraindications to perform the proper technique e.g., coagulopathy and skin infection.
* Body mass index (BMI) ≥35 kg/m2.
* History of allergy to contrast medium.
* Previously operated traditional spine surgeries.