cyrilzakka/clinical-trials huggingface dataset:
Prednisone Plus Chloroquine for the Treatment of Hyper-reactive Malarial Splenomegaly

This randomized clinical trial will address a complication related to recurrent episodes of malaria in endemic areas - hyper-reactive malarial splenomegaly. We aim to assess the efficacy of chloroquine after prednisone-induction therapy compared to standard treatment of chloroquine alone in the treatment of adult patients with newly diagnosed hyper-reactive malarial splenomegaly.

Hyper-reactive malarious splenomegaly (HMS) is a known chronic autoimmune complication in areas where malaria is endemic. Patients with HMS complain most commonly of abdominal swelling or pain from the enlarged spleen and the condition is defined using clear clinical and laboratory criteria. HMS appears benign in most patients when seen first but if untreated, it leads to severe anaemia and also acute bacterial infections. There is familiar and ethnic clustering suggesting genetic basis. High prevalence rates have been reported in certain areas of Papua New Guinea, and Venezuela, and HMS is also common in parts of sub-Saharan Africa, including Sudan and Ghana.

The treatment of HMS is still empirical since no randomized trials have been done so far. Long term anti-malarial chemoprophylaxis is deemed the mainstay of therapy, but the optimal drug-regimen and duration are unknown. Three to six months may pass before a response is observed, and relapses may occur when therapy is discontinued.

On the basis of the observed benefit in experimental studies, glucocorticoids have been used for severe hyper-reactive malarial splenomegaly in various case reports. Because these cases had a favourable outcome and the drug tolerability was good, prednisone has become an attractive therapeutic option for this disease. Central to the pathophysiology of HMS is the overproduction of Immunoglobulin M due to a functional CD8 T-cell defect and the consequent expansion and activation of B lymphocytes. Glucocorticoids may have an immediate effect due to inhibition of the sequestration of immunoglobulin coated red blood cells by the mononuclear phagocyte system and a later effect due to glucocorticoid-induced inhibition of antibody synthesis. We aim to assess the efficacy of chloroquine after prednisone-induction therapy compared to chloroquine alone in the treatment of adult patients with newly diagnosed hyper-reactive malarial splenomegaly.

Eligibility Criteria:
Inclusion Criteria:

* Defining features of HMS including chronic massive splenomegaly (at least 10 cm below the costal margin); serum Immunoglobulin M elevated more than 3.1 g/L and high malarial antibody titres (above 640).
* Evidence of the polyclonal nature of the lymphocytes by serum immunoglobulin free light chains.
* Aged at least 18 years
* Haemoglobin level of \> 5 mg/d

Exclusion Criteria:

* known allergy to chloroquine,
* use of anti-malarial treatment within the preceding month,
* suspected coexisting diseases in which glucocorticoids are contraindicated (e.g. diabetes mellitus, peptic ulcer disease or any acute infection as defined clinically), and
* splenomegaly secondary to known infectious or haematological causes
Proteomic Analysis of Patients Undergoing Bariatric Surgery

The expression of proteins in the blood of obese individuals is different from the expression of proteins in healthy individuals, and is also different in individuals after bariatric surgery. Therefore, this research aims to better understand protein expression in patients indicated for surgical treatment of obesity, evaluating the pre-operative and post-operative status. The objective of this research is to better understand protein expression in patients indicated for surgical treatment of obesity, evaluating the pre-operative and post-surgery status.

The objective of this study is to analyze the Proteomics of obese patients in the preoperative context of bariatric surgery to evaluate which are the up-regulated proteins - potentially related to oncogenic metabolic pathways - and also the down-regulated proteins in the context of obesity - potentially protective in the context of cancer. As well as, evaluate the variation of these proteins, as well as the metabolic pathways with which they are associated, after weight loss promoted by bariatric surgery, in the period of 01 year after this intervention.

The proteomic study will be carried out based on the formation of pools organized based on the patients' pre- and postoperative similarities. Proteomic analyzes will be carried out on a high-performance liquid chromatography system (nanoUPLC) model Acquity Mclass, Waters. Coupled to a Quadrupole Mass Spectrometer-Time of Flight (QToF) Model Sunapt Xs, Waters. Finally, the raw data (raw mass spectra) will be analyzed by the PROGENESIS QI software (Waters) to identify the proteins.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years of age with a BMI above 35 kg/m² associated with comorbidity or BMI above 40 kg/m² without comorbidities,

Exclusion Criteria:

* Patients with a previous history of cancer;
* Underage patients
* Patients with other diseases predisposing to the development of cancer: cirrhosis, ulcerative colitis, Barrett's esophagus, etc.
* Patients who have previously undergone bariatric surgery;
The Effectiveness of Thoracal Epidural Steroid and Local Anesthetic Injection

The primary objective was to evaluate the effectiveness of thoracic interlaminar epidural injections in alleviating pain and enhancing function in patients suffering from chronic mid and/or upper back pain.

Materials and Methods One hundred patients were randomly divided into two groups, each consisting of 50 patients. Group I received only a local anesthetic, while Group II received a combination of local anesthetic and steroids. The random assignment to either Group I or Group II was determined using a simple computer-generated sequence.

Outcomes were evaluated using the Numeric Rating Scale (NRS) and the revised Oswestry Disability Index (rODI). Patients who showed significant improvement for more than four weeks after the first two procedures were deemed successful. Those who did not were classified as failed participants. Significant improvement was defined as a reduction of more than 50% in both NRS and rODI scores, with assessments conducted at baseline and at 3, 6, and 12 months post-treatment.

The center where the study was conducted: Ankara University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Division of Algology, Ankara, Turkey


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* \> 6 months pain duration
* Failed conservative management (including medication, physical therapy, and exercise programs)
* Facet joint pain ruled out (confirmed through diagnostic blocks)

Exclusion Criteria:

* \< 18 years old
* Having a psychological illness
* Allergies to local anesthetics or steroids
* Thoracic facet joint pain
* Significant disc herniation
* Infection ( which were ruled out by pre-procedure blood tests and C-reactive protein levels)
Impact of Ketoflex 12/3 Diet on Early-to-Mid Stage Alzheimer's Progression

This study investigates the effects of the Ketoflex 12/3 diet on the clinical progression of early-to-mid stage Alzheimer's disease. The study evaluates cognitive function, metabolic changes, and overall health outcomes in participants following the Ketoflex 12/3 dietary protocol.


Eligibility Criteria:
Inclusion Criteria:

* Age between 50-85 years
* Clinical Dementia Rating (CDR) score of 0.5 or 1
* Diagnosis of Alzheimer's disease (AD) according to NINCDS-ADRDA criteria

Exclusion Criteria:

* Alcohol and/or substance dependence
* Diagnosis of chronic renal failure
* Diagnosis of another neuropsychiatric disorder
* Presence of amalgam dental fillings and/or failure to have them removed following the SMART protocol
Glivec Phase II Pediatric Study

The purpose of this study is to determine whether Glivec is effective, in children, adolescents and young adults, in the treatment of malignant disease in which evidence suggests a potential pathogenic role of one or more of the tyrosine kinases known to be inhibited by Glivec.


Eligibility Criteria:
Inclusion Criteria:

* Patients from 6 months to 21 years of age.
* Malignant disease documented by conventional criteria to be refractory to standard, approved therapy, or for which no conventional therapies of definitive benefit exist.
* Immunohistochemistry documentation of positivity of either Kit (CD117) or PDGF-R in tumor tissue relevant. Each positive tumor will be centrally reviewed before inclusion of the patient in the trial.
* Measurable or evaluable disease.
* WHO Performance status 0,1, or 2 or Lansky Play Scale \>= 50%.
* Adequate organ function, defined as the following: total bilirubin \< 1.5 x ULN, SGOT and SGPT \< 2.5 x UNL (or \< 5 x ULN if hepatic disease involvement is present), creatinine \< 1.5 x ULN, ANC \> 1x 109/L, platelets \> 75 x 109/L.
* Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.
* Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
* Life expectancy of more than 6 weeks.
* Written, voluntary, informed consent, including consent for retrieval and investigational use of tissue samples for evaluation signed by parents or young adult patients.
* National and, when needed, local ethical approval.

Exclusion Criteria:

* Patient with hematological disease positive for the chimeric BCR-ABL fusion protein or for c-kit.
* Patient has received any other investigational agents within 28 days of first day of study drug dosing.
* Female patients who are pregnant or breast-feeding.
* Patient has another severe and/or life-threatening medical diseasePatient has an acute or known chronic liver disease (e.g., chronic active hepatitis, cirrhosis).
* Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
* Patient has received chemotherapy within 4 weeks (6 weeks for nitrosourea, mitomycin-C or any antibody therapy) prior to study entry unless urgent enrollment needed and approved by the study coordinator.
Diva - The Effects Of 12 Weeks Of Treatment With High Dose Valsartan (320 Mg) To Amlodipine On Endothelial Function In Hypertensive Subjects With The Metabolic Syndrome

A STUDY ON WHETHER AN ANTIHYPERTENSIVE MEDICATION PREVENTS DAMAGE TO WALLS OF VEINS IN FEMALE PATIENTS WITH THE METABOLIC SYNDROME (OVERWEIGHT AND OTHER DISORDERS).


Eligibility Criteria:
Inclusion criteria:

Subjects must meet the following inclusion criteria at Visit 1, Visit 2 and Visit 3.

Inclusion criteria for Group A (overweight postmenopausal females with high-normal blood pressure/ mild Stage I hypertension)

1. Non-smoking female outpatients diagnosed as postmenopausal based on age (48 - 65 years) and self-reported absence of menstrual periods for at least one year.
2. Mean blood pressure between 130 - 149 mm Hg systolic and/or 85 - 94 mm Hg diastolic

   • When systolic blood pressure and diastolic blood pressure fall into different categories (high normal versus mild stage I hypertension), the higher category should be selected to classify or group the subject.
3. Body mass index greater than or equal to 26 but less than or equal to 41 kg/m2
4. Subjects who agree not to alter their diet or exercise routine during the study and comply with study specific restrictions 24 hours prior to the next scheduled study visit
5. Subjects who have read, signed and received a copy of the informed consent form prior to the initiation of any study procedures and who agree to participate in all aspects of the study

Exclusion Criteria:

* 1. Non-smoking female outpatients diagnosed as postmenopausal based on age (48 - 65 years) and self-reported absence of menstrual periods for at least one year.

  2. Mean blood pressure between 90 - 129 mm Hg systolic and/or 50 - 84 mm Hg diastolic.

  3. Body mass index greater than or equal to 26 but less than or equal to 41 kg/m2
Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease

Crohn disease (CD) usually evolves by surges interspersed by periods of unpredictable remission. the probability of recurrence of CD in a patient in remission is even stronger if it pre-exists endoscopic lesions of the intestinal mucosa.

The mucosal healing exploration needs the realization of an ileo-colonoscopy under general anesthesia which is an invasive procedure, restrictive and expensive, thus prohibiting its too frequent repetition. we do not currently have noninvasive and reliable markers able to predict the occurrence of thrust of CD and allow the introduction of a more suitable treatment.

Indeed, relapse prevention is the best way to avoid complications and formation of lesions that lead to the irreversible medical treatment failure and surgery.

Since during the CD, it is the immunological changes that lead to inflammation and lesions, we make the assumption that the ability of certain markers immunological to predict a relapse of CD is higher than that of other in particular inflammatory markers.

This work should help to identify the profile of patients with CD in remission but at high risk of recurrence. It will specify i) the potential new markers immunological, from the pre-clinical research, predict the onset of a recurrence of CD ; ii) the predictive interest of different inflammatory markers used in routine or during the CD evaluation ; iii) Finally, the stress and the management of stressful events in the occurrence of a relapse.

This work also will specify the evolution of different markers at the moment of thrust


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years.
* Patient with CD previously diagnosed according to standard criteria.
* Patient remission (HBS≤4) for at least 3 months and has not received corticosteroids (including budesonide) in the 3 months before.
* Patient without concomitant treatment of Crohn's disease or as stable dose (5-ASA, corticosteroids, immunosuppressants, anti-TNF) immunosuppressants (azathioprine, Purinethol, methotrexate) and / or anti-TNF and / or 5- amino salicylates (5-ASA) for at least 6 months.
* Patient who signed a consent.
* Patient affiliated to a social security scheme.

Exclusion Criteria:

* A patient with an active CD (HB score≥5).
* Patient who relapsed in the previous three months before inclusion.
* Patient who received corticosteroids (including budesonide) in the 6 months prior to inclusion.
* Patients on stable dose of non-anti-TNF in the 6 months prior to inclusion.
* Patient taking nonsteroidal anti-inflammatory drugs or antibiotics.
* Patient with complications of intestinal sub-occlusion type fistulas or abdominal abscesses.
* Patient with exclusive perianal disease or a predominate perianal manifestation.
* Pregnant women (examination).
* Patient who is the subject of extensive intestinal resection (\> 1 m).
* Patient with ileostomy or colostomy.
* Patient on legal protection measure or who does not have the legal capacity to consent
* Lack of signed written consent of the patient.-
Immersive Technology and Virtual Reality as a Health Support Tool in a Residence for the Elderly

The purpose of this clinical trial is to learn more about the potential for using virtual reality in older adults living in residences for elderly to maintain health (physical activity, cognitive activity, social behaviors). The main questions it aims to answer are:

* To what extent can virtual reality be a tool to support health in older adults?
* What are the support needs of older adults in learning to use this immersive technology?

Participants are invited to complete 5 training sessions on the use of a virtual reality headset. At the beginning and end of each session, participants will complete a questionnaire on their perception of their experience. During the sessions, the participants are asked to test games that mobilize the upper limbs. Two learning modalities are set up in two separate groups. These modalities aim to test two different support formulas in order to compare the support needs of the elderly in the use and integration of virtual reality to support the activities and health of this population.


Eligibility Criteria:
Inclusion Criteria:

* Independent person living in the sponsor's retirement home

Exclusion Criteria:

* Having a pacemaker
* Being at risk for epilepsy
Dietary Assessment and Mycotoxin Exposure in Celiac Disease

Celiac disease (CD) is the most common autoimmune enteropathy in Western Countries. Gluten free diet is the only available therapy but few is known about its nutrient content and mycotoxin exposure.

Celiac disease (CD) is the most common autoimmune enteropathy in Western Countries, occurring in genetically susceptible individuals, elicited by the gluten ingestion. By definition the disease responds to gluten withdrawal, so currently gluten free (GFD) diet is the therapy for celiac patients. It is known that gluten rich products are important source of nutrients on the other hands it is not clear if gluten exclusion from the diet could have a negative effect on the nutritional status of CD patients.

Another concern related to the GFD could be the high exposure to mycotoxins due to the high concentration of maize in GF products.

AIM The aim of this study is to estimate the nutrient intake and the dietary exposure of all mycotoxin types in a group of treated celiac patients vs. non-celiac subjects.

METHODS We will enroll celiac patients and healthy controls. Exclusion criteria for celiac patients will be: 1) diagnosis of CD less than two years 2) age under 18 or over 70 3) associated metabolic or chronic disease 4) pregnancy or lactation 5) being vegetarian or vegan. Exclusion criteria for the healthy subjects will be the same with the exception of the diagnosis of CD.

Total food and beverage consumption will be assessed by means of a 7 days long questionnaire. All participants will be trained by a nutritionist to record all food consumed and the completed forms will be returned and reviewed during a face-to-face interview at which portions size were quantified in standard units. Participants will be asked to weigh all foods and drinks consumed and to provide a detailed description of each food, including methods of preparation and recipes, whenever possible. In case of Gluten Free Foods, patients will be asked to precisely note the name of the manufacturer or to provide the food label.

The nutrient intake was calculated using a software application linked to the food database of the European Institute of Oncology integrated with the nutrient composition of 60 commercial GF foods. The computer output will consist in the evaluation of the mean daily intake of macro nutrients for each subject, in terms of carbohydrates, protein and lipid. Food items consumed will be also collapsed into food categories; pasta, bread, potatoes, flours, different cereals, fruit, vegetables, milk, cheese, eggs, fish, oils and fats, biscuits, sweet snacks, breakfast cereals, candies, chocolate, soft drinks, juices, coffees, teas, alcoholic beverages. For each subject, the mean daily intake of each food category will be calculated.

The 24-h urines were collected at the end of the registration period and analyzed for mycotoxins.

Eligibility Criteria:
Inclusion Criteria:

* celiac disease diagnosis
* GFD for at least 2 years

Exclusion Criteria:

* follow a vegetarian diet
* being affected by important systemic or psychiatric disorders
* incapacity to fill the questionnaires
Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple Sclerosis

The purpose of this study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.

Multiple sclerosis (MS) is in all probability an autoimmune disease causing severe neurological disability due to inflammation and degeneration in the central nervous system (CNS). MS affects over 1 million people worldwide. Central neuropathic pain is associated with approximately 30% of all patients with MS. MS-accompanying pain has a major impact on the patients' quality of life as usual conventional analgesics are little effective. The aim of this clinical study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis acc. to McDonald diagnostic criteria
* EDSS score between 3 and 8 (incl.)
* Patients who are in a stable phase of multiple sclerosis
* Patients with MS-related central neuropathic pain for at least 3 months

Exclusion Criteria:

* Severe concomitant diseases
* Certain concomitant therapies (in particular: pain influencing concomitant therapies)
* Dronabinol intake within the last 12 months prior to study entry or Marihuana use within one month prior to study entry
Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants

To assess pharmacokinetics parameters for nalbuphine after intravenous and intranasal administration in infants. Also effect on pain score: Neonatal Infant Pain Score (NIPS) and safety will be evaluated with summary of Adverse Events.

Inclusion criteria are: Infants 29 days-3 months, minimum Body weight 3.0 kg, Indications: septical work up.

Exclusion criteria are: Infants who were born prematurely (before 37 weeks gestation), known kidney or liver disease, known chronic illness.


Eligibility Criteria:
Inclusion Criteria:

* Infants 29 days-3 months
* Minimum Body weight 3.0 kg
* Indications: septical work up
* Parent has been informed about the study and has signed Informed Consent Form

Exclusion Criteria:

* Infants who were born prematurely (before 37 weeks gestation)
* Known kidney or liver disease
* Known chronic illness
* Documented previous adverse reaction to nalbuphine
* Treatment with a depressant drug within 5 days prior to study
* Epistaxis, nose trauma (only for the intranasal application)
* Barriere of language
Association Between Iron Reserves and Perioperative Neurocognitive Disorders

Iron metabolism disorder have been identified as the pivotal contributor in the pathogenesis and progression of perioperative neurocognitive disorders. However, the association between iron reserves and perioperative neurocognitive disorders risk remains elusive. This retrospective cohort study aimed to explore the impact of preoperative serum ferritin levels on the risk of postoperative delirium in elderly patients undergoing non-neurosurgical and non-cardiac procedures.


Eligibility Criteria:
Inclusion Criteria:

* Geriatric surgical patients ≥65 years old

Exclusion Criteria:

* preoperative use of antipsychotics
* diagnosis or history description of preoperative cognitive disorders including dementia and Parkinson's
National Health and Nutrition Examination Survey 24-hour Urine Collection Feasibility Study, 2013

A 24-hour urine pilot study was conducted as part of the 2013 NHANES to test the feasibility of implementing a 24-hour urine collection as part of NHANES in 2014.

The 24-hour urine pilot study was conducted March - June 2013 in three NHANES locations. A random half-sample of non-pregnant US adults, aged 20-69 who were examined in the NHANES mobile examination center were selected. Participants received instructions, started and ended the urine collection in a urine study mobile examination center (UMEC), and answered questions about collection. A random half of participants who collected a complete 24-h urine were asked to collect a second 24-h urine. Urinary sodium, potassium, chloride, and creatinine excretion were analyzed.

Participation rates in two other post-examination components, the Physical Activity Monitor and the Dietary Recall, were monitored to determine whether collecting a 24-hour urine had an effect on response rates for the two components.

Eligibility Criteria:
Inclusion Criteria:

* 20-69 year old adults examined in the NHANES mobile examination center

Exclusion Criteria:

* pregnant, unable to respond for themselves