cyrilzakka/clinical-trials huggingface dataset:
Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer Using Combination Therapy

Study of NGM120 in subjects with advanced solid tumors and and pancreatic cancer (Part 1 and 2) and metastatic castration resistant prostate cancer (Part 3).


Eligibility Criteria:
Inclusion Criteria (Part 1 and 2):

1. Have histologically confirmed metastatic pancreatic adenocarcinoma. Recurrent unresectable pancreatic cancer is acceptable as long as the treatment is first-line.
2. Have not received any approved chemotherapy, except in the adjuvant setting.
3. Life expectancy of at least 12 weeks
4. Male subjects must agree to use contraception as per protocol during the treatment period and for at least 90 days after the last study treatment administration and refrain from donating sperm during this period.
5. Provision of an archival tumor sample (within 5 years). If an archival sample is unavailable, a fresh biopsy can be obtained during Screening. If archival tissue or biopsy sample is unavailable, the subject is ineligible.

Inclusion Criteria (Part 3 Prostate Cancer):

1. Metastatic, castrate resistance, histologically confirmed prostate cancer; continuous medical castration for ≥8 weeks prior to screening.
2. Effective castration with serum testosterone levels \<0.5 ng/mL (50 ng/dL; 1.7 nmol/L).
3. Have serum GDF15 levels ≥1300 pg/mL.
4. Have experienced PSA progression under 1 or more lines of ADT in the absence or presence of radiographic and/or clinical progression, who decline or are not eligible to receive chemotherapy.
5. Have had PSA doubling time of \>3 months.

Exclusion Criteria (All parts):

1. Subject was using immunosuppressive medications within 14 days before Screening with the exception of topical (intranasal, inhaled, and local injection), systemic (prednisone equivalent 10 mg/day or less), or as needed for hypersensitivity reactions such as computed tomography (CT) scan premedication.
2. Subject has active infections or other serious underlying significant medical illness, abnormal and clinically significant laboratory findings or psychiatric illness/social situation.
3. Subject is using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants, cochlear implants, or other electronic medical equipment.
4. Subject has documented immunodeficiency or organ transplant.
5. Subject has an untreated central nervous system disease, leptomeningeal disease or cord compression.
6. Subject has a history, or presence, of significant cardiovascular diseases; including uncontrolled hypertension, clinically relevant cardiac arrhythmia, unstable angina or myocardial infarction within 6 months before randomization, congestive heart failure \> New York Heart Association Class II, severe peripheral vascular disease, corrected QT (QTc) prolongation \>470 msec, clinically significant pericardial effusion.
7. Subject has a history or presence of documented inflammatory bowel disease.
8. Subject is known to be positive for human immunodeficiency virus (HIV) infection.
Efficacy of Inhalation of Essential Oil on the Reduction of Inhalants Craving

Inhalants, which are neurotoxic central nervous system (CNS) suppressants, are frequently abused by young adults. Unlike other CNS depressants, including alcohol and opiates, no treatment is currently approved for inhalants dependence. In this report, a novel approach of substitution treatment for inhalants addiction was explored in a double-blinded, randomized, controlled crossover design to examine the effects of inhalation of essential oil (EO) and perfume (PF) on the reduction of cue-induced craving for inhalants in a cohort of thirty-four Thai males with inhalants dependence. The craving response was measured by the modified version of Penn Alcohol Craving Score for Inhalants (PACS-inhalants)


Eligibility Criteria:
Inclusion Criteria:

* Participants with ability to smell if they could correctly identify 3 out of 5 odors, namely fish sauce, lemon, onion, basil, and jasmine.
* Individuals with inducible picture-cues inhalant craving based on a 50% increase in craving score from baseline.

Exclusion Criteria:

* Individuals with a history of major psychiatric disorders, including psychotic and mood disorders
* Individuals with illicit substance dependence other than inhalants
* Individuals with allergic reactions to essential oil or perfume.
Evaluation of Cortisol and Bile Acids Metabolism in Obese Patients

Bariatric surgery is currently the most efficient treatment for obesity. The sustained weight loss and metabolic improvement seen following Roux-en-Y gastric bypass (RYGB), is explained partly by modifications in hormones including bile acids (BA). After RYGB, an increased total BA pool and a reduction in hepatic cortisol exposure is observed. Hydroxysteroid 11-β dehydrogenase 1 (HSD11B1), steroid 5α-reductases (SRD5A), and steroid 5β-reductases, AKR1D1 (also a BA metabolizing enzyme), are three enzymes involved in the metabolism of cortisol in the liver and are known to participate in metabolic syndrome. Their activity has been shown to be decreased after RYGB. Interestingly, the mechanisms explaining the modification of hepatic cortisol exposure and the activity of theses enzymes after RYGB are unknown. In view of the few data suggesting a link between cortisol metabolism and bile acids, this work aim to study and characterize this link in a context of RYBP


Eligibility Criteria:
Inclusion Criteria:

* Non-menopausal women
* BMI between 35 and 50 kg/m² included
* Social insured
* Ability to give consent

Exclusion Criteria:

* moderate and severe kidney insufficiency
* hepatic insufficiency
* known gallbladder lithiasis
* history of cholecystectomy or cholecystectomy planned during the gastric bypass
* history of bariatric surgery except gastric band and gastric balloon
* history of type 1
* treatment interfering with the cortisol metabolism: taking oral or inhaled glucocorticoids within the last 6 months
* treatment by BA as ursodeoxycholic acid, bile acids sequester, statin, fibrate stopped less than 4 weeks ago
Gene Polymorphism in Tinea Versicolor

Blood samples will be taken from cases presenting with recurrent tinea versicolor , after confirmation of diagnosis by wood's light and KOH examination, for the detection of gene polymorphism in IL17 A and IL17 F.

In addition , serum samples from patients and controls will be tested for 25(OH)2 D3


Eligibility Criteria:
Inclusion Criteria:

* - Patients with recurrent pityriasis versicolor (active now) and not taking treatment for it.
* Patients of both genders.
* Age ≥18 years old.

Exclusion Criteria:

* - Patients with other cutaneous diseases.
* Patient's having dandruff (scaly scalp) even if not symptomatizing.
* Pregnant and lactating females, children, prisoners, cognitively impaired or mentally disabled subjects.
* Patients with autoimmune diseases.
* Patients with immunodeficiency diseases.
* Immunosuppressed patients e.g. HIV, diabetics, organ transplant, malignancy, patients taking immunosuppressive drugs e.g. chemotherapy, cortisone.
Combination of Corticotherapy and Intensive Insulin Therapy for Septic Shock

This study will compare, in adults with septic shock, the safety and efficacy of a combination of moderate doses of corticosteroids and intensive insulin therapy to that of moderate doses of corticosteroids. In addition, this study will compare the efficacy and safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone

Objectives:

Comparison, in patients with septic shock, of efficacy and safety of the combination of moderate doses of corticosteroids and intensive insulin therapy to that of moderate doses of corticosteroids; and of efficacy and safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone Methods

Study design :

This is a multicenter, prospective, randomised trial on parallel groups

Study treatments :

Experimental arm A:

A1=50 mg iv every 6 hours of hydrocortisone (hemisuccinate), 50µg through the nasogastric tube of 9 alpha fludrocortisone, for 7 days AND strict control of blood glucose levels with a target of 4,4 to 6 mmol/L using continuous iv infusion of insulin up to intensive care unit discharge.

A2=50 mg iv every 6 hours of hydrocortisone (hemisuccinate) for 7 days AND strict control of blood glucose levels with a target of 4,4 to 6 mmol/L using continuous iv infusion of insulin up to intensive care unit discharge.

Control arm B:

B1:50 mg iv every 6 hours of hydrocortisone (hemisuccinate), 50µg through the nasogastric tube of 9 alpha fludrocortisone, for 7 days.

B2:50 mg iv every 6 hours of hydrocortisone (hemisuccinate)for 7 days. Study Primary outcome : In-hospital mortality

Sample size calculation :

The expected in-hospital mortality rate in the control group is 50%. To detect an absolute reduction in in-hospital mortality rate of 12.5 %, that is 37.5% in the experimental arm versus 50% in the control arm, and considering risk alpha of 0,05 and a risk beta of 0,20, 254 patients per treatment arms are needed, for a total of 508 patients.

Eligibility Criteria:
Inclusion Criteria:

Patients admitted in intensive care units for septic shock and meeting all following criteria

* Proven infection
* Need for vasopressor to maintain systemic arterial tension above 90 mmHg
* Multiple organ dysfunction as defined by a SOFA score ³ 8.
* Need for treatment with moderate dose of corticosteroids

Exclusion Criteria:

One of the following :

* Pregnancy
* Less than 18 years old
* Moribund (i.e. expected to die on day of intensive care unit admission)
Caffeine to Reduce Mechanical Ventilation in Preterm Infants

Most premature infants require mechanical ventilation for prolonged periods of time and a significant proportion of them develop Bronchopulmonary Dysplasia (BPD). Caffeine is a stimulant of the respiratory center and has been used for the treatment of Apnea of Prematurity in infants not requiring mechanical ventilation or to facilitate weaning from mechanical ventilation by starting therapy shortly before extubation. Recently the use of Caffeine in ventilated infants has been initiated earlier because of the reported reduction in BPD. However there is paucity of data supporting this practice.

Because protracted mechanical ventilation and supplemental oxygen increase the risk of developing BPD, a therapy that would facilitate the reduction of the respiratory support and shorten its duration is desirable. Therefore, it is of importance to evaluate the effects of early Caffeine initiation and administration during the course of mechanical ventilation in preterm infants by means of a randomized placebo-controlled trial.

Hypothesis:

The primary hypothesis of this study is that early use of caffeine in mechanically ventilated preterm infants will reduce the time to first elective extubation and secondarily, that this will reduce the total duration of mechanical ventilation and oxygen supplementation, and reduce the incidence and severity of BPD.

Objective:

The objective of this trial is to evaluate the effects of early caffeine use during mechanical ventilation on the time to first elective extubation, total duration of mechanical ventilation and oxygen supplementation, and the incidence of BPD.

Study Design:

This will be a single-center prospective, randomized, double-blind, placebo controlled clinical trial.

Population:

Premature neonates born between 23 and 30 completed weeks of gestation, who require mechanical ventilation within the first 5 days of life will be enrolled. Infants with major congenital anomalies or small for gestational age will be excluded.

Methods:

Infants will be randomized within the first 5 days to receive a study drug consisting of either blinded Caffeine citrate or blinded Placebo (equivalent volume of normal saline). Infants will continue to receive the study drug until the first elective extubation.


Eligibility Criteria:
Inclusion Criteria:

* Premature neonates born between 23 and 30 completed weeks of gestation.
* Requiring mechanical ventilation within the first 5 postnatal days
* Written-informed parental consent for the study

Exclusion Criteria:

* Major congenital anomalies
* Small for gestational age
Hematopoietic Stem Cell Transplantation Based on Pharmacokinetic and Pharmacodynamic Modeling

In this study the investigators plan to develop a method to determine optimal busulfan dose through pharmacokinetic study.

Busulfan is a highly toxic drug with narrow therapeutic window used for the conditioning of hematopoietic stem cell transplantation. High exposure is associated with systemic toxicity such as veno-occlusive disease (VOD) and underexposure is associated with graft failure or relapse. In this study we plan to develop a method to determine optimal busulfan dose through pharmacokinetic study.

Eligibility Criteria:
Inclusion Criteria:

1. Hematopoietic stem cell transplantation with busulfan based conditioning
2. Age: no limits.
3. Performance status: ECOG 0-2.
4. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. Heart: a shortening fraction \> 30% and ejection fraction \> 45%. 2. Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal. 3. Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
5. Patients must lack any active viral infections or active fungal infection.
6. Appropriate donor is available: Matched in 6/6 of A, B, DR loci.
7. Patients (or one of parents if patients age \< 19) should sign informed consent.

Exclusion Criteria:

1. Pregnant or nursing women.
2. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
3. Psychiatric disorder that would preclude compliance.
Propolis for Patients With Chronic Kidney Disease.

To evaluate the effects of propolis extract on inflammation in participants with chronic kidney disease.

Specific objectives

To assess before and after the intervention period:

* The expression of transcription factors (nuclear factor-kB), antioxidant enzymes (heme-oxygenase-1), inflammasome receptor, peroxisome proliferator-activated receptor-γ, as well as the levels of inflammatory cytokines (IL-6, Tumor nuclear factor-α, C-reactive protein, interleukin 1) and E-selectin adhesion molecules;
* The levels of protein expression of inflammatory markers and antioxidant enzymes;
* The profile of the intestinal microbiota of stool samples from the research participants;
* Plasma levels of substances reactive to thiobarbituric acid and oxidized low density lipoprotein as a marker of oxidative stress;
* Routine and anthropometric laboratory variables, indicative of the metabolic profile of the research participants;
* Assess blood pressure, 6-minute walk test, recovery heart rate and chair lift test to assess the functional capacity of the research participants;
* Assess atherogenic risk;
* Food intake and nutritional status; Compare data between the intervention and control groups.

Chronic kidney disease (CKD) has chronic systemic inflammation as an important component of multifactorial origin, a factor related to both the progression and outcomes of CKD, being involved in all causes of mortality in these patients, such as cardiovascular disease. In this context, some nutritional strategies have been proposed as an adjuvant therapeutic alternative to modulate inflammation, starting from the consolidated knowledge of the role of nutrients and bioactive compounds on the expression of genes related to inflammation and oxidative stress, factors that feed on each other. In view of this scenario, propolis, a substance made up of a combination of several chemical components with broad potential biological activity, appears as a promising alternative to modulate inflammation in patients with CKD. However, clinical evidence to assess the effects of propolis in patients with CKD is scarce, and there are no studies that have investigated its effects on gene expression and markers related to inflammation in these patients. Thus, the present project proposes a longitudinal study of the clinical trial type that aims to evaluate the effects of propolis alcoholic extract on transcription factors and inflammatory markers in patients with CKD.

Eligibility Criteria:
Inclusion Criteria:

• Aged 18 years or older

- with fistula arteriovenous

Exclusion Criteria:

* Patients pregnant
* Smokers
* Using antibiotics in the last three months
* Using antioxidant supplements as antioxidant vitamins, probiotic, prebiotic, symbiotic and antibiotics in the last three months
* Clinical diagnosis of infectious diseases
* Clinical diagnosis of Cancer
* Clinical diagnosis of AIDS - for PD patients - no peritonitis
A Comprehensive Assessment of Altered Embodiment in Individuals With Spinal Cord Injury

Spinal cord injury (SCI) occurs when trauma or other factors damage the spinal cord, disrupting the flow of sensory information from the body to the brain. This interruption can interfere with embodiment-the body awareness and physical sensations processed by the brain-sometimes leading to a phenomenon called disembodiment.

For people with SCI, disembodiment may appear as unusual body sensations, like feeling that a limb is in a different position than it actually is. Such changes in body awareness can impact daily life, mental health, and rehabilitation outcomes.

Despite its importance, the study of embodiment in SCI remains limited. This project aims to explore how SCI alters embodiment, focusing on its specific characteristics, the effects on daily life, and the underlying brain activity as measured by functional magnetic resonance imaging (fMRI). Both people with and without SCI will participate.

Procedure: Participants will complete a single examination lasting 2 to 2.5 hours, including approximately 55 minutes in the MRI scanner (with preparation and follow-up).


Eligibility Criteria:
Inclusion Criteria for all participants:

* Age between 18 and 60
* Normal or corrected-to-normal visual acuity
* German or Italian native speaker

Additional Inclusion Criteria only for individuals with SCI:

* Diagnosis of traumatic spinal cord injury
* Lesion level below T1 (first thoracic vertebra)
* Time since injury \>= 12 months
* Residual sensation on the upper leg (sensory capability of 1 or higher on at least one leg in the dermatomes L2 and L3 for both light touch and pin prick).

Exclusion Criteria for all participants:

* Pregnancy or breastfeeding
* Diagnosis of other psychiatric or neurological disorders (e.g. epilepsy, tumor in the central nervous system)
* Confirmed diagnosis of alcohol and/or drug abuse with active consumption within the last 6 months
* Confirmed diagnosis of traumatic brain injury, intended as visible changes in the brain diagnosed by a radiologist
* Stroke
* Inability to perform study procedures (e.g. inability to consent)

Additional Exclusion Criteria for both HC and SCI undergoing the fMRI procedure:

* Active medical devices (e.g. cardiac pacemaker)
* Inability to perform study procedures (e.g. claustrophobia)
Levetiracetam as add-on Treatment of Myoclonic Jerks in Adolescents + Adults

A double-blind, placebo-controlled study to assess the efficacy of adjunctive treatment with LEV 3000mg/day in reducing myoclonic seizures in adolescents and adults suffering from idiopathic generalised epilepsy and to evaluate the safety of LEV in the same population.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing myoclonic seizures (IIB) that are classifiable according to the International Classification of Epileptic Seizures. To ensure an idiopathic generalized epilepsy population, only these subjects with the diagnosis of juvenile myoclonic epilepsy (JME), juvenile absence epilepsy (JAE) or epilepsy with generalized tonic- clonic seizures on awakening must be included.
* Presence of at least eight days with at least one myoclonic seizure (IIB) per day during the eight weeks of the Baseline period.
* Absence of brain lesion documented on a CT scan or MRI; if a CT scan or MRI has not been performed within the past five years before Visit 1, a CT scan (or MRI where legally required) should be performed during the Baseline period.
* Presence of EEG features consistent with idiopathic generalized epilepsy on an EEG recorded during the Baseline period or no more than one year before Visit 1.
* Male/female children ≥ 12 years of age or adult ≤ 65 years of age at Visit 1.
* Subject on a stable dose of one standard anti-epileptic treatment for at least four weeks before Visit 1.

Exclusion Criteria:

* Previous exposure to levetiracetam.
* History of partial seizures.
* History of convulsive or non-convulsive status epilepticus within 3 months prior to Visit 1.
* Subject taking vigabatrin or tiagabine, subject on felbamate with less than 18 months exposure, and subject under vagal nerve stimulation or ketogenic diet.
* Subject taking any drug (except the concomitant AEDs) with possible CNS effects.
Micronutrient Status in Pediatric Palliative Care

The goal of this observational study is to determine the micronutrient levels in patients in the Pediatric Palliative Care Clinic. The main question it aims to answer are:

• What is the frequency of micronutrient deficiencies in pediatric palliative care patients?

Palliative care is an important health service provided with a multidisciplinary approach to improve the quality of life of children with progressive and life-threatening diseases and to manage symptoms effectively. This service aims to provide children with a good life experience by meeting the physical, psychological, social and spiritual needs of patients and their families.

Micronutrients contain important nutritional components such as vitamins, minerals and other nutrients that are essential for maintaining normal functions of the body. Micronutrient deficiencies affect at least half of children under five years of age. In a study conducted in pediatric oncology patients, micronutrient deficiency was shown to have a frequency of 74%, and selenium deficiency in particular negatively affected clinical outcomes. Contrary to recommended nutrient intakes (RNI) and expert opinion for healthy children, evidence-based recommendations for micronutrient requirements in critically ill children are not available. However, in pediatric palliative care, if the nutritional history indicates inadequate nutritional intake and/or growth indicates malnutrition, nutritional deficiencies that may have systemic effects, such as iron and vitamin B12 deficiency, need to be investigated.

This article aims to fill the gap in the literature by determining the micronutrient levels of pediatric palliative care patients hospitalized in the Pediatric Palliative Care Clinic. The research aims to contribute to a better understanding of the nutritional needs of patients in pediatric palliative care and to direct treatment approaches more effectively.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in a pediatric palliative care service

Exclusion Criteria:

* Patients who are hospitalized without having chronic, complex, progressive or life-threatening diseases (for off-label reasons)