cyrilzakka/clinical-trials huggingface dataset:
Gene Expression in Normal Tissue and Tumor Tissue From Patients Who Have Undergone Surgery For Kidney Cancer

RATIONALE: Studying the genes and proteins expressed in tissue samples from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This laboratory study is evaluating gene and protein expression in normal tissue and tumor tissue from patients who have undergone surgery for kidney cancer.

OBJECTIVES:

Primary

* Determine the expression levels of novel genes and proteins (HFARP, HAMGR28, HE9NG77) in frozen normal tissue and tumor tissue samples from patients who have undergone nephrectomy for renal cell cancer.
* Correlate gene and protein expression levels with disease stage, tumor size, and pathology reports (e.g., cell type, grade, and tissue architecture) in order to evaluate the rate of gene and protein expression as targets for future therapeutic interventions.

Secondary

* Compare proteomic screening of potential biomarkers using existing plasma and/or urine samples from patients with renal cell cancer or breast cancer stored in the CCCWFU Tumor Tissue Core with tissue samples from patients enrolled in this study.

OUTLINE: Normal and tumor tissue collected from patients who have undergone nephrectomy and diagnostic and therapeutic intervention for renal cell cancer is analyzed for histopathological expression and compared to normal kidney cells by northern blot. Tissue samples are evaluated by RNA and protein extraction and analyzed by gel electrophoresis, blotting, and phosphor-imaging for induction or suppression of genes and protein levels. These data are correlated with clinical stage, tumor size, and histopathological grade and architecture of the patient's disease.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed renal cell cancer
* Clinical staging (if available)
* Underwent nephrectomy for renal cell cancer
Pharmacologic MRI in Cocaine Addiction

In the proposed study, the investigators will assess the brain response to medication probes the investigators have previously studied with SPECT. The brain response to ondansetron and lidocaine infusions will be measured Arterial Spin Labeling and functional connectivity MRI (fcMRI).

An extensive effort has been mounted to understand the neurobiologic mechanisms involved in the development and persistence of cocaine addiction and tendency to relapse. Although the last two decades have resulted in an explosion in our understanding of the biological mechanisms of reward, establishing the relevance of this knowledge to the addictive process has been problematic. Most importantly, this information has been of limited utility in offering new pharmacologic treatment approaches to addicted patients - particularly those with cocaine addiction. Over the past 15 years our laboratory has published multiple studies using pharmacologic probes to explore the biologic underpinnings of cocaine addiction using single photon emissions computerized tomography (SPECT) technology. More recently, however, functional magnetic resonance imaging (fMRI) has offered several advantages over SPECT and is now a favored approach, e.g. fMRI allows the continuous measurement of neural responses rather than a very limited time period with SPECT (1-3 minutes every 48 hours). Using fMRI \[including both ASL (Arterial Spin Labeling) and fcMRI (functional connectivity\], the neural response can be measured throughout the 60 min that follows infusion, allowing identification and capture of the maximal brain response period that may occur at any time during this 60 min. In the proposed study, we will assess the brain response to two of the probes (scopolamine and lidocaine) we have previously studied with SPECT.

Eligibility Criteria:
Inclusion Criteria:

* Cocaine dependence (cocaine patients)
* identify cocaine as their present primary drug of use
* Patients must have used cocaine within the previous 4 weeks (by patient history) and be abstinent for at least 1 week.
* No drug dependence (healthy control population).

Exclusion Criteria:

* Other medical or psychiatric disorders that may effect neural functioning.
* Medications that may effect brain functioning
Characteristic and Evolution of an Atypical IgE-mediated Cow Milk Allergy Form With Hands and Feet Angio-oedema

Cow milk allergy is one of the most frequent food allergy among children. Cow milk protein's avoidance is needed until spontaneous recovery during the two first years of life. A atypical clinical form with angio-oedema of hands and feet which is associated with high rate of lactoserum's IgE might be a hope of an earlier recovery.

Cow Milk allergy is one of the most frequent pediatric food allergy and occurs during the first months of life. It is due to an inappropriate reaction of immune system against the human body. Its treatment is the avoidance of the cow milk proteins. Its spontaneous recovery occurs mostly during the first years of life with the decreasing of the specific IgE and the clinical tolerance to cow milk proteins.

Two shorts cas reports (3 and 5 patients) have described a clinical form of IgE-mediated cow milk allergy with angio-oedema of hands and feet. This clinical form is associated with more increasing of specific IgE against lactoserum proteins than caseine's. However it has been showed that casein is a marker of cow milk allergy persistence. It might be possible that this atypical form of cow milk allergy progresses favorably towards a restoration of tolerance earlier than the clinical form without angio-oedema of the extremities

Eligibility Criteria:
Inclusion Criteria:

* Patients with a concordant history of IgE-mediated CMA (skin reaction within the next hours of cow milk proteins intake, regression of symptoms with avoidance of cow milk, +/- recurrence of identical symptoms when readministration)
* Patients with documented positive awareness markers (skin test and/or specific IgE \> 0,1 kilo units of allergen-specific IgE per liter (kUA/l ))
* Patient followed at the pediatric allergology consultation at the Pediatric Hospitals of Nice

Exclusion Criteria:

* patients without IgE specific performed in the first month after the reaction
* patients who have had only 1 documented specific IgE test
Observational Study on Efficacy and Safety in Patients Using NovoMix® 30 for the Treatment of Diabetes

This study is conducted in Asia. The aim of this observational study is to evaluate the efficacy on blood glucose control while using NovoMix® 30 FlexPen® under normal clinical practice conditions in Korea. A clinical safety profile will be also evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Any patient with type 1 and type 2 diabetes who are treated with NovoMix® 30
* Patient who signed on informed consent form

Exclusion Criteria:

* Patients who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit
* Patients who were previously enrolled in this study
* Patients with a hypersensitivity to NovoMix® 30 or to any of the excipients
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
Incidence of Parkinson's Disease Among Veterans

This is a database study. Medical records will be reviewed in order to document a new or pending diagnosis of Parkinson's disease and in order to learn more about the disease process. Other than the time that it takes to complete a medical record authorization form, no other human subject participation will be needed.


Eligibility Criteria:
chart review
Visual Maturation in Premature Newborns According to Factors Influencing Its Development

The purpose is to describe the level of visual maturation of premature newborns at term equivalent age.

The secondary purpose is to determine factors associated to an altered level of visual maturation, through an exploratory approach.


Eligibility Criteria:
Inclusion Criteria:

* Infants born before 33 weeks of amenorrhea and hospitalized at CHRU Nancy

Exclusion Criteria:

* Parental opposition
* Ocular malformation
* Face malformation
* Cranial stenosis
* Chromosomal abnormality
Management of Pain in Lumbar Arthrodesis

KETAMINE AND DEXAMETASONE IN THE MANAGEMENT OF PAIN IN LUMBAR ARTHRODESISPhase IV prospective randomized controlled single-center clinical trial to determine the effect of intravenous ketamine and dexamethasone administration perioperatively in patients undergoing lumbar arthrodesis.

The need to carry out this study is to evaluate the analgesic effects after the administration of ketamine and dexamethasone intravenously perioperatively in patients undergoing lumbar arthrodesis and, likewise, study the incidence of pain and protocolize perioperative analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age\> 18 years
* ASA I-III.
* Lumbar arthrodesis.
* Patients who have signed the preoperative informed consent for participation in the study.

Exclusion Criteria:

* Unstable coronary heart disease
* Glaucoma
* History of allergy to ketamine, dexamethasone, or morphic chloride
* Dementia or inability to understand IC and study
* Pluricomplicated diabetes mellitus difficult to control
* Patients who have taken an experimental drug 30 days before the start of the study or who are included in any type of study of an experimental drug
SURGE: Supporting UnderRepresented Minorities in Genomics-based Cancer Trial Enrollment (Intervention)

SURGE aims to increase equity in clinical trial enrollment by addressing barriers to genomic testing, which is increasingly needed to assess precision clinical trial eligibility and access standard precision therapies. The study is an interventional pilot meant primarily to assess the feasibility of the intervention. The intervention is comprised of a patient navigator, text message questionnaire, and informational video.

Supporting UnderRepresented populations in Genomics-based cancer trial Enrollment (SURGE) is a multimodal intervention to address medical literacy and unmet social determinants of health (SDoH) needs as barriers to tumor somatic genomic testing consent among historically underrepresented patients (HUP) diagnosed with advanced solid or hematologic malignancies as a prerequisite to precision therapies and/or clinical trial eligibility. Our key hypothesis is that video-based education with or without 1:1 patient navigation will address medical literacy and unmet SDoH barriers, supporting HUP decision-making about genomic tumor consent. We will conduct a type 1 hybrid implementation effectiveness study among a cohort of HUP seeking medical oncology care at two academic and two community practice sites.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18 years or older)
* Black, Latinx, OR older adult (age 70 years or older)
* Scheduled for a new patient consultation
* Suspected or confirmed advanced malignancy (requiring active treatment)
* Gastrointestinal, hematologic, or thoracic cancer
* DFCI patient at Longwood/Chestnut Hill, DFCI satellite at St. Elizabeth's Medical Center, or DFCI satellite at Merrimack Valley

Exclusion Criteria:

* Malignancy or former malignancy that requires only surveillance
* Not continuing care at a participating DFCI site
* Speaks a language other than English or Spanish
* Unable to provide consent
Evaluation of Dexpanthenol and Hyaluronic Acid Eye Drops on Corneal Epithelialization After Trans Epithelial PRK

The aim of this prospective, contralateral, randomized, double-blind, placebo-controlled study is the evaluation of the performance of a fixed combination of dexpanthenol and hyaluronic acid preservative-free eye artificial tears eye drops, in corneal wound healing after trans epithelial photorefractive keratectomy. One eye of each patient, randomly determined, will be assigned to receive artificial tears containing a combination of dexpanthenol-hyaluronic acid (study group) while the fellow eye will receive Placebo / identical combination containing the same ingredients and hyaluronic acid without dexpanthenol (control group). The drops will be applied hourly postoperatively, starting one hour after the surgery. All subjects will be treated until the day of complete reepithelialization or a maximum of 7 days postoperatively. Researchers will compare the epithelialization between the two eyes. The primary endpoint is the time to reepithelialization.The secondary endpoints are the intra-individual differences measured in each eye in terms of epithelial defect size in each visit, subjective evaluation of pain (discomfort) and subjective evaluation of vision.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged ≥ 18
* Bilateral trans PRK for the correction of myopia using the Schwind Amaris 1050RS laser at the same treatment zone (6.5mm)
* Signed written informed consent Ability and willingness to participate in all examinations

Exclusion Criteria:

* Known hypersensitivity or intolerance to any component of the product
* Previous refractive surgery
* Myopic refractive error higher than 8.00 diopters (D)
* Anisometropia higher than 2.00 D
* Ocular or systemic disease that could affect epithelial healing
18F-FDG PET/CT Imaging for Breast Cancer

Purpose To investigate the ability of 18F-FDG PET/CT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III and locoregional recurrent breast cancer (BC) which can affect the choice of treatment.

Hypothesis The hypothesis is that 18F-FDG PET/CT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III or locoregional recurrent BC.

Objectives

Primary:

To evaluate if a 18F-FDG PET/CT scan in the initial work up of patients diagnosed with stage II/III or locoregional recurrent BC will lead to change in staging and/or treatment.

Secondary:

* Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET/CT scan compared with the patients with unchanged stage of disease following 18F-FDG PET/CT.
* Obtain size of the primary BC from CT/MRI scan and evaluate if these metrics are correlated to outcome.
* Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome.
* Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome.
* Blood and tumor samples for molecular characterisation:


Eligibility Criteria:
Inclusion Criteria:

* Patients with high risk primary or recurrent breast cancer
* Non pregnant women \> 18 years
* Not receiving active treatment of other cancer types.
* Eastern Cooperative Oncology Group (ECOG) status 0-2.

Exclusion Criteria:

* Pregnant woman
* Males
* Age under 18
* Patients receiving active treatment for other cancers
* Poor general conditipon (ECOG 3 or higher)
Using Equine Therapy in Dementia Cognitive Stimulation

The goal of this clinical trial is to learn if integrating equine therapy in memory workshops in mild to moderate Dementias can improve cognitive function, quality of life and mood. The main question\[s\] it aims to answer is:

Does the mediation of a horse in memory workshops increase its effects ?

Researchers will compare traditional memory workshops, memory workshops using equine therapy and a control group to see if the equine therapy mediation will increase cognitive functions, mood and quality of life in individuals with mild to moderate Dementias.

Participants will participate in 8 weekly sessions of equine therapy memory workshops / traditional memory workshops / a control group will not have any interventions during that period. All subjects will be evaluated pre and post intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Have been medically diagnosed with Major Neurocognitive Disorders
* Scores between 0.5 and 2 on the Cognitive Dementia Rating scale (CDR) (Berg, 1982)
* Adults of all genders, aged 65 and over; and
* Willingness to participate in a memory workshop; e) willingness to interact with a horse.

Exclusion Criteria:

* Expressed fear, aversion, or has had a negative experience with horses
* Allergy or other medical condition which did not allow contact with horses.
Effect of American Ginseng on Exercise-induced Muscle Soreness

Healthy participants will ingest American ginseng daily or a placebo for four weeks prior to engaging in a unaccustomed exercise bout designed to induce mild-moderate muscle soreness. Muscle soreness will be assessed via decrements in muscle strength and with a self-rating of perceived soreness before and several times after the exercise.

Healthy men and women will consume either 2000 mg of American ginseng daily (four 500 mg pills will be taken at four different times during the day always with food/meals) or a placebo (4 cellulose) for four weeks prior to engaging in a 40 minute downhill treadmill jog (12% decline) at a speed of 7 miles per hour. Participants will consume one pill with breakfast, one pill with lunch, one pill with dinner and another pill with a snack either between meals or prior to bedtime. The exercise will be consist of five, eight minute bouts of jogging with two minutes of rest/recovery in between. The degree of muscle soreness will be assessed using a Biodex strength testing machine (isometric and concentric isokinetic torque), and a self-rating of perceived soreness on a scale from zero to ten. All of the above measures will be taken before and several times after the downhill jogging protocol.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women, (women must weigh between 55-65 kg., while men must weigh between 75-85kg).
* Participants must not have engaged in any endurance run training in the past 9 months.

Exclusion Criteria:

* Injured
* Regular runners
* Pregnant (or with any chance they may become pregnant)
* Breast-feeding
* Diabetics or those taking medication for diabetes
* Insomniacs
* Schizophrenics
* Hyper- or hypotension
* Cancer
* Irregular heartbeats
* Heart disease
* Females with endometriosis or uterine fibroids
* Those who have surgery scheduled during the study or within the two weeks following the completion of the study
* Those taking warfarin or medication for depression.
A Study Combining Personalized Neoantigen-based Dendritic Cell Vaccine With Microwave Ablation for the Treatment of Hepatocellular Carcinoma

This is a single institution, open-label, multi-arm, pilot study of a personalized neoantigen-based dendritic cell (DC) vaccine combined with microwave ablation in subjects with Hepatocellular Carcinoma (HCC). Patients with HKLC stage IIa HCC are eligible for enrollment. In this study, the investigators are looking at the safety, feasibility of the personalized neoantigen-based DC vaccine combined with microwave ablation as well as the T cell immune response to the vaccine.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed patients with primary hepatocellular carcinoma, HKLC Stage IIa.
2. Age is greater than 18 years old, male or female.
3. The tumor size is 3cm-5cm, and the lesions are \<3.
4. ECOG score \< 2, Child-Pugh classification A or B.
5. The participants freely sign informed consent;

Exclusion Criteria:

1. Pregnant or breast-feeding; psychiatric problems, addiction, or any other disorder that prevented informed consent;
2. Portal vein thrombosis or extrahepatic metastases;
3. White blood cell count \<2 x 10e9/L, platelet count \<40 x 10e9/L, serum creatinine \>110 mol/L, aspartate aminotransferase \>3 times upper limit, serum bilirubin \> 2.5 times upper limit, prothrombin time\> 19 seconds.
4. Active uncontrolled infection;
5. Concurrent systemic corticosteroid treatment
6. Primary immunodeficiency or systemic autoimmune disease; being treated with immunosuppressive drugs for other diseases;
7. Clinically significant ischemic heart disease or cardiac failure;
8. The investigator believes that there are other reasons that are not suitable for inclusion.
Recipient Site Pre-conditioning in Fat Grafting

This study aims to investigate the preparation of the recipient site prior to autologous fat grafting (AFG) using different methods.

Autologous fat grafting is emerging as a powerful tool for soft tissue reconstruction and augmentation and is widely used in plastic surgery. However, there is great variability in terms of long-term graft retention (survival). Moreover, the recipient site preparation is the phase of the procedure which received less attention in clinical and pre-clinical investigations. To provide information regarding an effective preparation of the recipient site may potentially lead to improvements in fat graft survival.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Patients presenting with contracted scars or body contouring deformities, especially as a result of previous radiation therapy or infection, in and around the breast.
* Body mass index superior than 18.5

Exclusion Criteria:

* Need for antiplatelets drugs in the 5 days before surgery and 3 days after,
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study due to language problems, psychological disorders, dementia of the participant,
* Previous enrolment into the current study,
* Enrolment of the investigator, his or her family members, employees and other dependent persons,
* Patients with haemorrhagic diatheses.