cyrilzakka/clinical-trials huggingface dataset:
Sleeve Gastrectomy in Adolescents With Complicated Morbid Obesity and NAFLD

Pediatric obesity has become a critical health problem worldwide, increasing the premature onset of obesity-related morbidities. This phenomenon has induce an increase in the incidence of serious health complications starting in childhood and adolescence. Lifestyle interventions, including diet and regular physical activity, are the cornerstone of current medical management. Unfortunately, these interventions are often ineffective in providing a meaningful and long-lasting weight loss necessary to change health outcomes. It has been demonstrated that an early intervention in obesity in children and adolescents, inducing weight loss by performing bariatric surgery in carefully selected patients, can dramatically reduce the risk of adulthood obesity and obesity-related diseases, including non-alcoholic fatty liver disease (NAFLD).

Recent evidence suggest that bariatric surgery can improve metabolic complications and liver involvement in patients affected by morbid obesity.


Eligibility Criteria:
Inclusion criteria:

* BMI\>40 kg/m2 with severe comorbidities
* Type 2 diabetes mellitus
* Moderate-to-severe sleep apnea
* Pseudotumor cerebri
* NASH with advanced fibrosis (ISHAK score\>1)
* BMI\>50 kg/m2 with mild comorbidities
* Hypertension
* Dyslipidemia
* Mild obstructive sleep apnea
* Chronic venous insufficiency
* Panniculitis
* Urinary incontinence
* Impairment in activities of daily living
* NASH
* Gastroesophageal reflux disease
* Severe psychological distress
* Arthropathies related to weight

Exclusion Criteria:

* Documented substance abuse problem
* Medically correctable cause of obesity
* Disability that would impair adherence to postoperative treatment, present pregnancy, or breast-feeding

The patients included in the present study were enrolled according to the recent indications for bariatric surgery in severly obese adolescents of Hepatology Committee of European Society of Pediatric Gastroenterology, Hepatology And Nutrition (ESPGHAN) (JPGN 2015;60: 550-561)
Tocilizumab for Cytokine Release Syndrome Prophylaxis in Haploidentical Transplantation

Tocilizumab will be administered prior to transplantation in order to prevent the onset of cytokine release syndrome and its complications associated to peripheral blood haploidentical hematopoietic stem cell transplantation with post-transplant cyclophosphamide

Cytokine release syndrome (CRS) is a common and potentially severe toxicity associated to haploidentical peripheral blood (PBSC) hematopoietic stem cell transplantation (Haplo-HSCT), which was described previously in the context of immunotherapies for acute lymphoblastic leukemia such as chimeric antigen receptor T-cells and blinatumomab.

CRS is characterized by immune system activation with a high level of circulating inflammatory cytokines including IL-6. Haplo-HSCT recipients have a high incidence of post-transplant fever, with elevated IL-6 in absence of documented infection. CRS occurs more frequently when using PBSC, and severe cases have been associated to delayed engraftment, increased transplant-related mortality and lower survival.

Tocilizumab an IL-6 receptor-targeted monoclonal antibody has been effectively used to treat CRS in several scenarios, including Haplo-HSCT. Therefore, there is considerable interest for the development of a successful strategy for CRS prevention with tocilizumab, potentially eliminating complications. However, it is currently unknown whether the use of this monoclonal antibody can adversely affect the outcome of Haplo-HSCT recipients.

Eligibility Criteria:
Inclusion Criteria:

* Haploidentical transplant recipients
* Informed consent signature
* Previous diagnosis of any neoplastic, metabolic or autoimmune disease

Exclusion Criteria:

* History of immune deficiency virus infection
* Hepatitis C or B virus infection
* Documented bacterial of fungal infection prior to tocilizumab infusion
* Previous use of tocilizumab
Clinical Evaluation of Stenfilcon A Contact Lenses

This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control).

This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control) over 3 hour of wear time in a Japanese population.

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is Japanese
* Has had a self-reported oculo-visual examination in the last two years.
* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and understood the informed consent letter.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
* Currently wears soft contact lenses.
* Has clear corneas and no active ocular disease.

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.
Effectiveness of Atraumatic Restorative Treatment Using Glass Ionomer Cement of Different Costs

Atraumatic Restorative Treatment (ART) is an alternative restorative technique for dental caries, applying the partial caries tissue removal philosophy using hand instruments, relative cotton rolls isolation, immediate restoration with Glass Ionomer Cements (GIC) and avoiding local anesthesia. The chosen material for this study will be the High Viscosity Glass Ionomer Cement (HVGIC) due to its unique physical-chemical properties as well as its applicability in challenging clinical situations where other materials would not be adequate. Although there are substantial evidences regarding GIC properties, information about GIC (with different costs) longevity is still weak. Therefore, the objective of this study is to assess the effectiveness of ART restorations performed with low-cost HVGIC in cavitated dentine carious lesions in primary and permanent molars. This will be a multicenter randomized controlled double-blind (patient and operator) clinical trial performed with 680 primary and/or permanent molars in children between 4 and 9 years old presenting cavitated dentine carious lesions in occlusal and occlusal-proximal surfaces. The tooth will be considered as the unit sample, which will be randomly allocated to the groups through a generated random list numbers and distributed in dark sealed envelopes opened only by dental assistants. Teeth in the test group will be submitted to restorative treatment with HVGIC Vitro Molar and those in the control group with HVGIC Fuji IX. The restoration effectiveness will be assessed by means of both clinical and bitewing x-rays control after 6 and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Children with at least one primary and/or permanent molar with dentine carious lesion in the occlusal and/or occlusal-proximal surface.

Exclusion Criteria:

* Special need patients, subjects under orthodontic treatment and/or systemically compromised.
* Teeth with restorations, sealants, developmental defects, deep carious lesions with pulpal exposure risk, fistula and/or abscess, and those with history of spontaneous pain.
Assessing the Symptoms of Obstructive Sleep Apnea

The purpose of this study is to investigate the correlation between health outcomes associated with the severity of obstructive sleep apnea (OSA) symptomatology, the findings will guide the design of interventional studies.

Obstructive sleep apnea is a condition characterised by periods of narrowing of the pharyngeal airways during sleep causing hypoxic and hypercapnic episodes with the cessation of ventilation. Considering the high number of overweight and obese individuals in Western society the understanding of the pathomechanisms behind OSA are important. This observational study aims to investigate the correlations between the severity of Obstructive Sleep Apnea assessed by the apnea-hypopnea index (AHI) and different health outcomes associated with the OSA.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index ≤39
* Not received any treatment for Obstructive Sleep Apnea.
* Is a non-smoker
* Is not epileptic
* Epworth Sleepiness Scale ≥ 10.
* Patient's on Statins or antihypertensive drugs are included as so frequent in OSA.

Exclusion Criteria:

* Body Mass Index ≥ 39.
* Presence of significant or unstable Renal, Liver or Heart Failure.
* Receiving anti-diabetic treatment.
* Is a smoker.
* Is epileptic
* Presence of significant or unstable psychological morbidities.
Can Dipyridamole Induce Protection Against Ischemia and Reperfusion Injury in Patients Undergoing Elective Coronary Artery Bypass Grafting (CABG)?

Rationale:

Due to western lifestyle human coronary arteries are prone to develop atherosclerotic plaques. Hence the heart is an important target organ for atherothrombotic complications: myocardial ischemia, arrhythmias, myocardial infarction and heart failure. To alleviate symptoms and decrease mortality in these patients, myocardial revascularisation is recommended. Coronary artery bypass grafting (CABG) is indicated in patients with severe atherosclerotic disease of all three coronary arteries or the left main stem coronary artery. Cardiac ischemia and reperfusion injury during CABG is inevitable and jointly accountable for complications that occur after CABG (e.g. death, myocardial infarction, arrhythmias, stroke, or renal complications). Dipyridamole has been shown to reduce ischemia reperfusion injury in healthy volunteers using an intermediate endpoint and may prevent cardiovascular death or event in secondary prevention after cerebrovascular disease. The investigators hypothesise that oral pre-treatment with dipyridamole can increase cardiac tissue tolerance against ischemia and reperfusion injury due to CABG. The investigators expect lower troponin-I release in patients who were pretreated with dipyridamole.

Objective: To study the effect of oral pretreatment with dipyridamole on high sensitivity (HS)-troponin-I release after CABG. Secondary objectives are whether oral pretreatment with dipyridamole reduces postoperative CABG arrhythmias, prolonged inotropic support, and duration of Intensive Care-stay. Further secondary endpoints are the effects of dipyridamole pretreatment on renal injury and post-ischemic recovery of contractile function (measured ex-vivo).

Hypothesis:

The investigators hypothesize that oral pre-treatment with dipyridamole can increase cardiac tissue tolerance against ischemia and reperfusion injury. The investigators expect lower HS-troponin-I release in patients who were pretreated with dipyridamole. Additionally the investigators expect the incidence of arrhythmias, need for prolonged inotropic support (longer than 24 hours postoperative) to be decreased in pretreated patients.


Eligibility Criteria:
Inclusion Criteria:

* Acceptation for CABG in RUNMC
* Informed consent

Exclusion Criteria:

* Recent myocardial infarction (STEMI or non-STEMI), during two weeks prior to inclusion
* Asthma
* Use of insulin
* Use of sulfonylurea derivates (e.g. glibenclamide, tolbutamide, gliclazide, glimepiride)
* Use of metformin
* Use of oral corticosteroids
* Use of dipyridamole
* Use of clopidogrel within 8 days prior to scheduled CABG surgery
* Chronic use of Non Steroid Anti-Inflammatory Drugs (NSAIDs)
* Off-pump surgery
Intralymphatic Immunotherapy in Increasing Doses, After Subcutaneous Immunotherapy

The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients that have already undergone subcutaneous immunotherapy will be treated with three intralymphatic injections in increasing doses; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo.

38 patients with seasonal allergic rhinitis that have recently (within 20 months) ended a full subcutaneous immunotherapy protocol with birch or grass allergen with improvement but not full symptom relief are recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55
* Accepted and signed informed consent.
* Recently (within 20 months) ended a full 3 year program with subcutaneous immunotherapy (SCIT) with amelioration of symptoms but not full symptom relief.

Exclusion Criteria:

* Previously subcutaneous immunotherapy (SCIT) with total symptom relief.
* Previously SCIT but no symptom improvement at all.
* Sensitizations to house dust mite or furry animals, with symptoms.
* Severe atopic dermatitis.
* Patients with significant diseases other than allergic rhinitis. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
* Patients with a respiratory tract infection in the past 4 weeks prior to Visit 2.
* Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants).
* Known autoimmune or collagen disease
* Cardiovascular disease
* Perennial pulmonary disease including asthma
* Hepatic disease
* Known renal insufficiency
* Cancer
* Hematologic disease
* Chronic infectious disease
* Any medication with a possible side-effect of interfering with the immune response
* Previous immuno- or chemotherapy, apart from SCIT
* Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers)
* Major metabolic disease
* Known or suspected allergy to the study product
* Obesity with BMI \> 30 since subcutaneous fat makes ultrasound imaging of lymph nodes harder which may risk the correct placement of injection.
* Patients who, in the opinion of the investigator, abuse alcohol or drugs within 2 years prior to Visit 1.
* Patients who have taken an investigational drug within 1 month or six half lives, whichever is greater, prior to Visit 1.
* Mental incapability of coping with the study
* Withdrawal of informed consent
Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer

Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.

Randomized clinical trial performed in woman with epithelial primary ovarian cancer (stage FIGO II, III and IV) or tumor recurrence. A cytoreductive surgery will be perform in all of the patients include in the trial, and it will be assign at randomization:

* HIPEC-arm: cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with paclitaxel (175 mg / m2) for 60 minutes at a temperature of 42-43º degrees; followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles.
* No HIPEC-arm: Cytoreductive surgery followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles.

Eligibility Criteria:
Inclusion Criteria:

* Women with histologically confirmed epithelial ovarian cancer (stage II / III / IV disease of FIGO) or tumor recurrences (the women of childbearing age need to have a negative pregnancy test)
* Complete cytoreduction: Index CC0/CC1 cytoreduction (residual tumor size after surgery, no visible (CC0) or less than 0.25 cm (CC1))
* No extra-abdominal tumor disease
* Absence of heart failure. Adequate renal and hepatic functions
* Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%

Exclusion Criteria:

* Patients with unresectable tumor or incomplete cytoreduction.
* Contraindications for treatment with paclitaxel: patients with severe hypersensitivity to paclitaxel or any of the excipients,pregnancy or lactation and patients with baseline neutrophil count \<1.500/mm3 (\<1.000/mm3 for patients with Kaposi sarcoma). Paclitaxel is also contraindicated in patients who have concurrent and severe infections.
* Extra-abdominal metastases or unresectable liver metastases
* Presence of other malignant tumor disease.
* Multisegmental complete bowel obstruction.
* Patients with severe medical problems that will preclude compliance with the study or with an unacceptable risk
* Patients who refuse treatment or consent to participate in study
Treatment of Non Alcoholic Fatty Liver Disease With Lifestyle Modification and Acupuncture

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of liver dysfunction worldwide. NAFLD may progress to nonalcoholic steatohepatitis (NASH) and in turn to cirrhosis. To date, the detailed pathogenic mechanism of NAFLD including steatosis and NASH is not fully characterized, although it is regarded as a hepatic manifestation of the metabolic syndrome, sometimes it occurs in the absence of a metabolic syndrome. Based on conventional models of "two-hit" and "multi- hit" hypothesis of NAFLD, the dysregulated lipid metabolism and insulin resistance are considered as the "first hit" of the liver and the following "second hit" or "multi-hit" likely involves oxidative stress, lipid peroxidation, increased inflammatory responses, induced hepatic fibrosis and apoptosis. This emphasizes the multi-factorial pathogenesis of NAFLD and the necessity to treat NAFLD with diabetes-like and multimodal strategy. Several changes in dietary intake have occurred in the past few years, including increased energy intake (24%), and increases in added sugars, flour and cereal products, fruit, added fats and total fat intake. The increasing prevalence of NAFLD is probably directly affected by the contemporary epidemics of obesity, unhealthy dietary pattern, and sedentary lifestyle. Currently, there are two major categories of NAFLD therapy: lifestyle interventions and pharmaceutical therapies, lifestyle interventions in terms of diet and physical activity are regarded as safe and effective, while pharmaceutical interventions showed limited efficacy with unknown safety in the long term ,therefore, the first line of treatment is lifestyle modification. Although lifestyle intervention dose positively affects NAFLD, it has limitations. Patients adherence to dietary intervention is 50%, while those who do adhere, find it difficult to maintain after 12 months. ). Mediterranean diet has been shown to be effective in reducing NAFLD, liver steatosis and improve insulin sensitivity. Acupuncture has been found as an effective treatment for improving quality of life in various medical conditions , including hepatitis . Acupuncture combined with life style intervention has been found effective in the treatment of obesity, metabolic syndrome in terms of weight, lipid regulation, glucose levels and various markers of inflammation. Acupuncture's effect on NAFLD has yet to be studied.

We suggest that acupuncture combined with life style intervention can be an effective treatment for NAFLD.


Eligibility Criteria:
Inclusion Criteria:

Above 18 years old No known metabolic pathology NAFLD diagnosis

Exclusion Criteria:

Known metabolic pathology Psychiatric diagnosis Auto immune disease Known Diabetes Hypertension
The Relationship Between Emotion Regulation and Psychiatric Disorder in Youth

According to the increasing worldwide prevalence rate of psychiatric disorders in youth, the mental health of youth is becoming more and more important.

Taiwan's Ministry of Health and Welfare reported the clibing suicide rate of youth in past five years and showed the prevention work and related intervention for youth's mental health was noteable. The definition of emotion regulation was "consists of the extrinsic and intrinsic processes responsible for monitoring, evaluating, and modifying emotional reactions, especially their intensive and temporal features, to accomplish one's goals." Emotion regulation strategies including "rumination", "avoidance", "suppression", "Problem-solving", "reappraisal", "acceptance", "social support", and "distraction".

Previous studies had examined the relationship between emotion regulation and mental health in youth; maladaptive emotion regulation would increase the individual's depressive and anxiety symptoms. Carstensen proposed social emotion theory in 1995 Selectivity theory (SST) refers to the need for emotion regulation, which activates Social participation in late adulthood. SST assumes that young people are more interested in social interaction behaviors related to information seeking and building self-concept. characteristics of youth affected by many normative challenges such as adolescence, school transitions, and more complex social Landscape; Adaptive emotion regulation will reduce risk of clinical emotion attacks of illness, especially depression and anxiety.To explore the relationship between emotion regulation and mental health from a psychosocial developmental aspect, we focused on the interaction between individual and environment. Compared with the previous generation, most youths of this generation were participating in social activities and building up interpersonal relationships through the internet, suggesting the internet was an important social context.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for the control group are as follows: (1) Understanding the content of the questionnaire. (2) Healthy adolescents aged 15 to less than 18 years and healthy adults aged 18 to 24 years.

The inclusion criteria for the experimental group are:

1. Understanding the content of the questionnaire.
2. Adolescents aged 15 to less than 18 years and adults aged 18 to 24 years.
3. Diagnosed with major depressive disorder, anxiety disorder, attention deficit hyperactivity disorder (ADHD), or adjustment disorder according to DSM-5.

Exclusion Criteria:

* The exclusion criteria for the experimental group are diagnoses of:

  1. organic brain injury
  2. schizophrenia
  3. autism spectrum disorder according to DSM-5.
Patient Preferences With Pharmaceutical Care: In-person Versus Digital Health

Digital pharmaceutical care, also known as e-pharmaceutical care or telepharmacy, refers to using digital technologies to provide remote pharmaceutical care services. It involves the application of digital tools and platforms to deliver medication-related services, patient counseling, medication management, and other pharmaceutical care activities. It allows patients to access pharmaceutical services conveniently from their homes or any location with an internet connection. This is particularly beneficial for individuals with limited mobility, those living in rural or underserved areas, or patients with difficulty visiting a physical pharmacy. However, it is essential to note that while digital pharmaceutical care provides many benefits, it may only suit some patients or situations. Some individuals may still prefer face-to-face interactions or may require hands-on assistance, especially for complex medication management. Healthcare providers should assess the appropriateness of digital solutions on a case-by-case basis and ensure patient privacy and data security when implementing digital pharmaceutical care services.


Eligibility Criteria:
Inclusion Criteria:

* Patients who took at least one medication in the past month
* Patient visiting two community pharmacies

Exclusion Criteria:

* Those refusing to participate
* Those with severe hearing or mental problems