cyrilzakka/clinical-trials huggingface dataset:
Monoclonal Antibody Therapy in Treating Patients With Recurrent Gliomas

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to determine the effectiveness of monoclonal antibody in treating patients with recurrent gliomas.

OBJECTIVES: I. Assess the toxic effects of intracystic administration of iodine-131-labeled anti-tenascin monoclonal antibody 81C6. II. Identify any objective therapeutic responses to this treatment in patients with recurrent cystic anaplastic gliomas.

OUTLINE: Radioimmunotherapy. Iodine-131-Labeled Anti-Tenascin Monoclonal Antibody 81C6, 131I-81C6.

PROJECTED ACCRUAL: Three to six patients will be entered at each dose studied.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial anaplastic glioma with a recurrent cyst requiring aspiration for symptom control Measurable cystic lesion confirmed by contrast-enhanced CT or MRI At least 3 months since radiotherapy to site of measurable disease unless unequivocal evidence of tumor progression Neoplastic cell reactivity with tenascin demonstrated by immunohistology with either a polyclonal rabbit antibody or a monoclonal murine antibody

PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Karnofsky 50-100% Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 1.5 times normal Alkaline phosphatase less than 1.5 times normal Renal: Creatinine less than 1.2 mg/dL Other: Negative pregnancy test Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since antineoplastic chemotherapy unless unequivocal evidence of tumor progression Endocrine therapy: Corticosteroids allowed if at lowest possible dose and dose stable for at least 10 days prior to entry Radiotherapy: See Disease Characteristics Surgery: Not specified
Restylane® for the Treatment of Tear Trough Deformity

The aim of this study is to investigate the effectiveness and tolerability of Restylane® for correction of tear trough deformity, using various injection techniques.


Eligibility Criteria:
Inclusion Criteria:

1. Female;
2. Age of 18 years or greater;
3. Indication for treatment of bilateral tear trough deformity;
4. Symmetry of tear trough deformity at baseline;
5. Subjects who understood and signed the Informed Consent Form (ICF) when entering the study, before performing any investigational procedure.

Exclusion Criteria:

1. Prior (\<1 year) or planning to undergo any surgery in the corporal area of interest for study;
2. Any type of comorbidity or clinical condition that, at investigator's discretion, could interfere with study assessments;
3. Diabetes mellitus type 1 or type 2;
4. Autoimmune diseases, collagenosis, decompensated endocrine diseases or any disease that, at investigator's discretion, could interfere with study assessments;
5. Using or have used within 3 months drugs such as corticosteroids, immunosuppressants or others collagen-production inhibitors;
6. Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months;
7. Pregnant or breastfeeding, or wishes to get pregnant within the next 12 months, or refuses to use appropriate contraceptive method (in case of women of childbearing potential);
8. Restylane® should not be used in any person who has hypersensitivity to any of the components of the product;
9. Active skin inflammation or infection in or near the treatment area;
10. Possessing any of the contraindications for use of Restylane®;
11. Septal fat herniation;
12. Severe elastosis (e.g., dermatochalasis);
13. Use of Vitamin E, gingko biloba, Aspirin or non-steroidal anti-inflammatory drugs (NSAIDS) within 1 week of treatment.
14. Use of tear trough injections in the last 12 months.
15. Use of anterior midface injections in the last 12 months.
Biomarkers for Post-COVID Conditions

The COVID-19 infection affects humans differently. While some recover quickly and fully, others develop serious illnesses and late complications. The term late complications describe symptoms that last for 12 weeks or longer after COVID-19 infection is detected. The aim of the present project is to investigate whether it is possible to identify genetic factors that occur more frequently in people suffering from COVID-19 late complications than in those who do not develop late complications. The investigators aim to develop a genetic profile that identifies individuals at high risk for late complications of COVID-19. Number and nature of late complications will be analysed to identify patterns in the incidence of late complications associated with certain genetic traits. The study is designed as a case-control study and is expected to include 500 subjects between 18 and 65 years of age who at least 12 weeks ago tested positive for COVID-19; 250 who suffer from late complications and 250 who have fully recovered.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years
* SARS-CoV-2 infection proven by a PCR test at least 12 weeks prior to inclusion
* Only cases: Referred to the Clinic of post-COVID conditions located in Region Zealand, Denmark

Exclusion Criteria:

* Need of being on a respirator during infection with SARS-CoV-2
* Only controls: complain about long covid 12 weeks or more after proven infection with SARS-CoV-2
Proof of Mechanism of a New Ketogenic Supplement Using Dual Tracer PET (Positron Emission Tomography)

A six month, placebo-controlled, parallel group project in which MCI participants will receive 30 g/day of a custom-made MCT-based ketogenic supplement or a matching placebo. Uptake of both the brain's fuels - ketones (as 11C-AcAc) and glucose (as FDG) - both before and after the intervention will be assessed by PET (position emission tomography) ; imaging and ketone pharmacokinetic as primary objective as well as fMRI, diffusion MRI and cognition.


Eligibility Criteria:
Inclusion Criteria:

* subjective memory complaint
* Montreal Cognitive Assessment (MoCA) score of 18-26/30 or a Mini-mental state exam (MMSE) score of 24-27/30
* autonomy for activity of daily living
* absence of depression

Exclusion Criteria:

* diagnosis of a major cognitive disorder
* diseases or psychiatric disorders that could interfere with participation
* uncontrolled diabetes (fasting plasma glucose \>7 mM or glycated hemoglobin \>6.5%)
* major depression or history of alcohol or substance abuse within the past 2 years,
* already supplementing with coconut oil or MCT
* vitamin B12 deficiency
* uncontrolled hypertension, dyslipidemia, or thyroid disease,
* visual or hearing impairment impeding comprehension
* participation in another intervention trial
* inability to lie down without moving for 60 min (for the brain imaging)
* presence of implanted metal objects or devices contraindicated for MRI (phase 1)
An Empirical Study of Perceived Hospital Service Quality: A Comparison of Inpatient, Outpatient and Emergence Patient

The authors employ a questionary approach to understanding the relational among patients' perceptions of inpatient, outpatient and emergency room service and their overall perceptions of service quality, satisfaction with hospital.The questionary was applied in total 300 patients (100 inpatients, 100 outpatients and 100 emergency patients).


Eligibility Criteria:
Inclusion Criteria:

* Patients who want to write our questionary.

Exclusion Criteria:

* Patients who reject to write our questionary.
Does Electromyography Improve Precision and Reliability of Neuromuscular Monitoring in Paediatric Patients

Neuromuscular monitoring is used as a standard surveillance method of neuromuscular function to ensure full recovery at the end of anaesthesia. The currently available devices properly provide respective information in adults but not in children. Furthermore, response to neuromuscular blocking agents differs between adults and children due to age-related differences in body composition, physiological function, and acetylcholine receptor density.

Recently, electromyographic (EMG) technologies to monitor neuromuscular function were increasingly developed including disposables for nerve stimulation and measurement of the compound muscle action potential in children. However, it is still unclear whether the precision and reliability of these devices is superior to the currently available neuromuscular monitoring for children based on kinemyography (KMG).

The ETCETERA study will test the hypothesis that neither EMG nor KMG provides inferior train-of-four readings to the respective reference method in infants and children below five years.

The ETCETERA trial is a randomized clinical agreement study which will prospectively enrol sixty-four children below five years of age scheduled for elective, non-cardiac surgery requiring general anaesthesia and neuromuscular blockade for optimisation of surgical conditions.

The children's neuromuscular function is measured on one hand with EMG and on the other hand with KMG in a randomised fashion. Additionally, randomisation will be stratified upon age groups: 1) neonates: birth to \<28 days, 2) infants 28 days to ≤3 months, 3) toddlers: \>3 months to ≤2 years, 4) children \>2 years to \<5 years.

Based on the high failure rate of currently available neuromuscular monitoring devices in infants and neonates, in this randomised agreement study we will primarily compare precision and reliability of EMG and KMG-measured Train-of-Four (TOF) values during spontaneous recovery from a rocuronium-induced neuromuscular blockade in neonates, infants, toddlers, and children \<5 years using the age-appropriate paediatric sensors.

Eligibility Criteria:
Inclusion Criteria:

* children and infants \< 5 years
* non-cardiac surgery requiring general anaesthesia and neuromuscular blockade
* signed informed written consent
* American Society of Anesthesiologists physical status \<4
* intraoperative positioning with access to both arms

Exclusion Criteria:

* allergy to neuromuscular blocking agents
* allergy to neuromuscular monitoring adhesive electrode
* neurologic disease
* surgical procedures outside the operating room
* children receiving neuromuscular blocking agents immediately before surgery
Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients (IMPROVE Study)

The main objective is to determine the performance of the simple eLIFT blood test for advanced liver fibrosis screening in NAFLD and/or alcoholic patients in primary care.

eLIFT, is a new blood fibrosis test specifically dedicated for general practitioners with simple parameters and easy "by head" calculation. Using the recommended cut-offs (eLIFT ≥8), eLIFT sensitivity was 86%. This result position eLIFT an as interesting tool for the screening of advanced liver fibrosis in large populations.

As our preliminary results come from very selected patients, i.e. patients from tertiary centres who underwent a liver biopsy, we now need to evaluate in the real condition of primary care setting whether the use of eLIFT will help general practitioners to screen advanced liver fibrosis in their asymptomatic NAFLD and alcoholic patients.

Eligibility Criteria:
Inclusion Criteria:

* NAFLD and/or alcoholic patient defined by ≥1 of the following criteria:

  * Excessive alcohol consumption: \>210 g/week (men), \>140 g/week (women)
  * Type 2 diabetes
  * ≥2 metabolic factors among: 1/BMI ≥25kg/m2; 2/elevated blood pressure (antihypertensive drug, or systolic blood pressure ≥130mmHg, or diastolic blood pressure ≥85mmHg), 3/dyslipidemia (lipid-lowering drug, or HDL cholesterol \<40mg/dl (men) / \<50mg/dl (women), or triglycerides ≥150mg/dl); 4/hyperferritinemia (\>300 ng/ml (men)/\>200 ng/ml (women))
  * Bright liver at ultrasonography without steatosis-inducing drug
* Obtaining the signature of the consent to participate in the study

Exclusion Criteria:

* Already ongoing specialized follow-up for a chronic liver disease
* Altered health status with poor short-term prognosis, not compatible with a screening procedure
* Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)
* Acute infection
* Inadequate understanding of the French language
* Pregnant, breastfeeding or parturient women
* Persons deprived of their liberty by judicial or administrative decision
* Persons subject to legal protection measures
* Persons unable to consent
* Refusal to participate
Limits of the Social Benefit Motive Among High-risk Patients: a Field Experiment on Influenza Vaccination Behaviour

Influenza vaccine uptake remains low worldwide, inflicting substantial costs to public health and health systems. Messages promoting social welfare have been shown to increase vaccination intentions, and it has been recommended that health professionals communicate the socially beneficial aspects of vaccination. This study aims to provide the first test whether this prosocial vaccination hypothesis applies to the actual vaccination behaviour of high-risk patients by comparing the effects of two motivational messages for promoting vaccination at a tertiary care public hospital in Istanbul, Turkey.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized at medical departments of the hospital who are on the day of discharge

Exclusion Criteria:

* Egg ellergy
* Previous allergic reaction to influenza vaccine
* Pregnancy
* Cognitive disability
Bayer/Cognitive Assessments With Multiple Sclerosis Subjects

This study is designed to identify a brief screening evaluation for MS patients that is sensitive and specific to the MS population and which correlates with the findings of our standard-of-care neuropsychological assessments.

Seventy five randomly identified patients will be evaluated. Consenting patients will perform a Symbol Digit Modalities Test (SDMT) and have the MS Center´s standard neuropsychological assessment performed. Tests comprising the standard assessment will be the RBANS (Randolph, 1998), Multiscore Depression Inventory, Cross and Clock Drawings. The selfreported Beck Depression Inventory (BDI-II) will also be obtained. An Expanded Disability Status Scale (EDSS) will be recorded for each patient. The RBANS consists of six scales labeled (1) Immediate Memory, (2) Visuospatial/ Constructional, (3) Language, (4) Attention, (5) Delayed Memory, and (6) Total. Depression will be assessed by the BDI and the MultiScore Depression Inventory.

The SDMT will be administered using standard instructions either orally or in writing. Use of the established norms for the SDMT will be used to determine if the MS patient is demonstrating some cognitive dysfunction. Scores less than 1.0 to 1.5 standard deviations below mean are suggestive of cerebral dysfunction. The results will be controlled for age, gender, and educational level.

Additionally, the results of the 75 patient assessments will be reviewed to see the concordance between the results of the SDMT and the Neuropsychological Battery. The association of cognitive dysfunction as identified by the SDMT will be correlated with each of the six RBANS scales and other parameters of the cognitive aspects of the Battery. Statistical analysis will determine the sensitivity and specificity of the SDMT in determining abnormalities as well as an optimum cutpoint. This analysis will indicate possible cognitive problems and the need for further testing and, potentially, intervention.

Eligibility Criteria:
Inclusion Criteria:

* EDSS at last visit ≤ 7.0
* Relapsing/Remitting or Secondary Progressive MS

Exclusion Criteria:

* Severe Depressive Illness: Beck Depression Inventory Score \> 55.
* Unable to read with/without glasses- Visual Acuity better than or equal to 20/60 in one eye.
* Unwilling to sign Informed Consent.
* Evidence on clinical examination of severe dementia at discretion of evaluating neurologist.
NUTRITION MATTERS: A Food is Medicine Intervention for African-American Adults With Multiple Chronic Conditions

African Americans have higher rates of diabetes, obesity, heart disease, and high blood pressure. In addition, middle-aged non-Hispanic Black adults develop multiple chronic conditions (MCCs) at an earlier age, which share most of the same risk factors, including poor diet and physical inactivity. The major goal of the proposed project is to develop a culturally tailored intervention focused on improving awareness, knowledge, diet quality, and physical activity in a cohort of AA adults with MCCs.

Chronic diseases and their risk factors are more common and severe for African Americans (AAs) and other racial and ethnic minority groups. The CDC reports that non-Hispanic Blacks are 30% more likely to have high blood pressure and twice as likely as White adults to be diagnosed with diabetes and heart disease or suffer a stroke. In addition, middle-aged non-Hispanic Black adults have higher levels of chronic disease burden and develop multiple chronic conditions (MCCs) at an earlier age. Since chronic diseases share most of the same risk factors, including poor diet and physical inactivity, the inherent potential exists for prevention. Food is Medicine refers to a spectrum of services and health interventions that recognize and respond to the critical link between nutrition and chronic illness. By addressing nutritional needs within the context of health care, Food is Medicine interventions play an important role in preventing and/or managing many of the chronic conditions that drive health care costs. In addition, social support is a key factor influencing health behavior change and aids in successful weight loss, weight management, and obesity program adherence. Thus, this project proposes to pilot a 12-week Food is Medicine intervention with a 3-month follow-up to improve awareness, knowledge, and healthy lifestyle behaviors - primarily nutrition and physical activity in a cohort of AA adults with MCCs. The proposed project will focus on health equity in that it will include nutrition education, interactive cooking demonstrations, the provision of healthy food, and organized walking groups necessary for improved rates of behavior change and the formation of new habits. The proposed project aims to improve physical activity and dietary intakes that influence diabetes, high blood pressure (directly linked to kidney health), and cardiovascular health that disproportionately affect the AA community.

Eligibility Criteria:
Inclusion Criteria:

* African American
* Age 35-64 years old
* must have been diagnosed with pre diabetes or diabetes and have one other diagnosed chronic condition, including obesity (BMI \>35), hypertension, and heart disease.

Exclusion Criteria:

* Individuals with a medical condition that interferes with their ability to modify their diet or engage in physical activity
Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions

Currently, the exploration of primary hemostasis (a physiological phenomenon used to stop bleeding) is imperfect because it is based on targeted tests for platelets or von Willebrand factor, without taking into account blood flow and other blood cells (red and white blood cells). Tests for whole blood and flow conditions exist, but there is currently no test that comes close to actual physiological conditions.

An exploration of whole blood haemostasis in a device that is similar to a blood vessel and at different flow conditions (venous and arterial) could help to better identify the risk of bleeding in predisposed patients (von Willebrand factor deficiency, antiplatelet therapy).

The objective of the study is to evaluate the performance of this new hemostasis test in whole blood and under flow conditions.

Participation in the study is ad hoc and is limited to adding a maximum of 4 citrated tubes (20 mL or the equivalent of 4 teaspoons) and 1 EDTA tube (5mL) to a routine blood sample (for patients) or during blood donation (for controls).


Eligibility Criteria:
Inclusion Criteria:

* person who has given oral consent
* adult
* blood donor at EFS Bourgogne Franche-Comté
* or patient with von Willebrand disease or major constitutional thrombopathy followed by the Resource and Competence Centre (CRC) - Constitutional Hemorrhagic Diseases of Dijon or Besançon
* or patient on antiplatelet drugs consulting for thrombosis at the Dijon Bourgogne or Besançon Hospital

Exclusion Criteria:

* a person who is not affiliated to or not a beneficiary of national health insurance
* person subject to court-ordered protection (curatorship, guardianship)
* pregnant, parturient or breastfeeding woman
* a person who is unable to consent
* person on anti-inflammatory treatment and serotonin reuptake inhibitor antidepressants (platelet function disorders)
Evaluate Rituximab in Obtaining PCR (Polymerase Chain Reaction) Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma

Researchers hope to learn if adding rituximab with high doses of chemotherapy and stem cell transplantation will help patients get rid of their lymphoma cells from the bone marrow and stem cell collections.

Following the first relapse, patients with follicular type of Non-Hodgkin's lymphoma may have an option to receive high dose chemotherapy followed by autologous (from you) blood stem cell transplantation. One of the common causes of relapse is persistence of lymphoma cells in the bone marrow and in the collected stem cell products.

Patients who do not have a complete response after traditional chemotherapy, have a greater chance of the lymphoma returning even after receiving high dose chemotherapy with stem cell transplantation. In order to improve the response and decrease the relapse rate, additional therapy may be used to kill the lymphoma cells by using antibodies both before and after the transplantation. Antibodies are protein made by white cells in our body to fight off infection and sometimes tumor. Rituxan (rituximab) is an antibody that is effective against your type of lymphoma. Researchers have reported that patients show an improved response and a lower chance of relapse when using rituximab with high dose chemotherapy with autologous stem cell transplantation. It is unknown how effective rituximab is in clearing persistence of minimal remaining disease in patients with follicular lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy-proven refractory CD20+ (cluster of differentiation antigen 20) Follicular lymphoma or transplant eligible mantle cell lymphoma in CR1 (complete remission 1) or later.
* Patients must be transplant eligible per KUCC BMT SOP (Kansas University Cancer Center Bone Marrow Transplant Standard Operation Procedures) with chemo-sensitive/marrow negative disease.
* Patients planning to harvest and hold may also be included as long as above criteria are met.

Exclusion Criteria:

* Pregnancy
* Zubrod performance status greater than 2
* Life expectancy is severely limited by concomitant illness.
* Uncontrolled arrhythmias or symptomatic cardiac disease precluding transplantation
* Symptomatic pulmonary disease precluding transplantation
* Serum creatinine greater than 1.8 mg/dL
* Serum bilirubin greater than 2 X upper limit of normal, SGPT (serum glutamate pyruvate transaminase) greater than 3 times upper limit of normal
* Evidence of chronic active hepatitis or cirrhosis
* Unable to sign informed consent.
* Allergy to Rituximab
Study on Breast Cancer Patient Perspectives of Exercise

The goal of the study is to establish the feasibility/willingness of breast cancer patients to delay surgery to do an exercise program, or be randomized to an exercise training program following treatment, and to see if that willingness correlates with prior physical activity history.


Eligibility Criteria:
Inclusion Criteria:

* women,
* breast cancer diagnosis,
* all races will be included.

Exclusion Criteria:

* men,
* those with no breast cancer (ductal carcinoma in situ),
* pregnant women,
* children