cyrilzakka/clinical-trials huggingface dataset:
Febuxostat for Tumor Lysis Syndrome Prevention in Hematological Malignancies of Paediatric Patients and Adults

The purpose of this study is to compare the exposure of febuxostat in pediatric patients (≥6\<18 years of age) and in adults suffering from hematological malignancies at intermediate to high risk of TLS and to compare the effect in terms of serum uric acid levels.

In the FLORET study it is planned to enroll 3 groups of patients in order to receive oral administration (film-coated tablets) of two different dose levels of febuxostat: children (from 6 to less than 12 years of age) will receive two different dose levels respectively; adolescents (from 12 to less than 18 years of age) will receive 80 and 120 mg/day respectively and adults (equal or major than 18 years of age) will receive 120 mg/day. The two dose levels for children and adolescents groups were to be sequentially administered, whereas the groups that will receive the first dose levels will simultaneously start the treatment at the study beginning. The individual treatment duration will be of 7 to 9 days, according to chemotherapy duration, as per Investigator's judgement.

Eligibility Criteria:
Inclusion Criteria:

male and female children of 6 to less than 12 years of age, adolescents of 12 to less than 18 years of age and adults from 18 years:

* scheduled for first cytotoxic chemotherapy cycle because of hematologic malignancies
* and at intermediate or high risk of TLS
* and with no access to rasburicase

Exclusion Criteria:

* patients with contraindications as per febuxostat summary of product characteristics
* patients with severe renal insufficiency
* patients with severe hepatic insufficiency
* patients with diagnosis of Laboratory TLS (LTLS) or Clinical TLS (CTLS)
Pan-immune-inflammation Value (PIN) in Behçet's Disease and Its Correlation With Disease Activity

Behçet's disease (BD) is a systemic vasculitis affecting both small and large blood vessels in the venous and arterial systems. It is a multiorgan disease with various manifestations, including mucocutaneous, articular, ocular, gastrointestinal, vascular, and neurological involvements. The aim of present study is to assess pan immune inflammation value (PIN) value in BD in comparison to healthy control ,assess the PIN value in association with demographics and clinical characteristics of Behcet patients and to assess the PIN value in association with disease activity.

Behçet's disease (BD) is a systemic vasculitis affecting both small and large blood vessels in the venous and arterial systems. It is a multiorgan disease with various manifestations, including mucocutaneous, articular, ocular, gastrointestinal, vascular, and neurological involvements. Inflammation of the vascular wall is the primary pathophysiology contributing to thrombosis in BD. Hematological and biochemical values are altered due to systemic inflammation and aberrant immune response. Neutrophils, lymphocytes, and platelets play a significant role in systemic inflammation and thrombosis. In addition to the number and volume of peripheral cells, changes in multiple cell count ratios, such as the platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocyte ratio (NLR), and monocyte-to-lymphocyte ratio (MLR), have become important predictors of the diagnosis, disease activity, s and severe organ damage in rheumatologic disorders. pan immune inflammation value (PIV) was first described by Fuca et al and used to evaluate the inflammation. Literature showed that PIV performed better than previous immune-inflammatory biomarkers, such as NLR in colorectal cancer patients. PIV is calculated from four blood cell counts, including neutrophils, platelets, monocytes, and lymphocytes. In some rheumatological diseases such as RA, familial Mediterranean fever, and vasculitis, PIV has been studied.

In clinical practice, hematological and inflammatory laboratory tests are easily accessible and cost-effective. It is important to determine which blood parameter will be more effective in detecting disease activity and monitoring the treatment response in BD. In our study, our aim is to investigate the association of PIN with demographics and clinical characteristics of BD patients and its correlation with disease activity.

Eligibility Criteria:
Inclusion Criteria:

* Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease .
* Accept to participate in the current study.

Exclusion Criteria:

* Individuals with other autoimmune diseases.
* Patients unwilling to participate in the study.
* Patients less than 18 years old.
* Patients with malignancy or infections.
* Pregnancy and lactation
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-104 in Healthy Volunteers

The purpose of this study is to evaluate the safety and tolerability of escalating doses of ODM-104 when given to healthy male volunteers.

The study is divided into two parts. Part one is a crossover study where healthy volunteers will receive two doses of ODM-104 and one dose of placebo. Part II of the study is a multiple ascending dose parallel group study where healthy volunteers will receive ODM-104 three times daily for seven days. Healthy volunteers taking part in Part II of the study will also receive levo/carbidopa and entacapone four times daily on day 1 and levo/carbidopa in addition to ODM-104 on day 9. The study will also look at the pharmacokinetic(how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-104.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects aged between 18 and 45 years
* BMI 18-30 kg/m2
* Weight 55-95kg
* Written informed consent
* Good General Health

Exclusion Criteria:

* Vulnerable subjects
* Veins unsuitable for repeated venipuncture
* Evidence of clinically significant cardiovascular, renal, hepatic, hematological, Gi, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disorder
* History of or positive test for drug abuse
* Any condition requiring regular concomitant medication
* Blood donation or significant loss of blood within 2 months prior to screening
* Abnormal 12 lead ECG finding of clinical relevance
* Heart rate (HR) \<50bpm or \>90bpm after 10 minutes in a supine position
* Systolic blood pressure \<90mmHg or \>140mmHg after 10 minutes in a supine position
* Diastolic blood pressure \<50mmHg or \>90mmHg after 10 minutes in a supine position
* Abnormal 24 hour Holter recording of clinical relevance at screening
* Any abnormal laboratory value, vital signs or physical examination causing a health risk to the volunteer
New Biomarkers in Axial Sypondyloarthropathy; SII and SIRI

investigators aimed to evaluate the relationship between Systemic Immune Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) and disease activity in patients with axial spondyloarthropathy (SpA).

The clinical characteristics and laboratory data of the patients and healthy controls participating in our study were obtained through the hospital system. Then, the new biomarkers SIRI and SII values were calculated. SIRI= neutrophil count\*monocyte count/lymphocyte count and SII= neutrophil count\*platelet count/lymphocyte count. Then, SIRI and SII values were compared between groups. The relationship between disease activity and SIRI and SII values in the patient group was examined.

Eligibility Criteria:
Inclusion Criteria:

* SpA patients diagnosed according to the 2009 Assessment of Spondyloarthritis International Society classification criteria
* 51 healthy controls working in our hospital,

Exclusion Criteria:

infections, coronary artery disease, kidney and liver dysfunction, cancer diagnosis, surgery in the last three months, diabetes mellitus diagnosis, hypertension and pregnant women
Interviews With Older People From Turkish Origin in Belgium About Advance Care Planning

Advance care planning (ACP) enables individuals to define goals and preferences for future medical treatment and care, to discuss these goals and preferences with family and health-care providers, and to record and review these preferences if appropriate. Research has shown that most Western patients express the need about what ACP entails.

Ethnicity creates an important cultural impact on how people look at life and death, so that there is an influence on making decisions about end-of-life care. The Turkish ethnic group is one of the largest visible non-Western minority groups in Western countries. Studies on how ACP is perceived among patients from Turkish origin are lacking.

The objective of this study is exploring the knowledge, experiences, point of views, preferences, attitudes, facilitators and barriers concerning advance care planning of older people from Turkish origin in Belgium. Semi-structured interviews (in the native Turkish language) will be used.


Eligibility Criteria:
Inclusion Criteria:

People:

* with Turkish origin who live in Belgium and are older than 65 years
* who have also given informed consent to participate in this qualitative interview study

Exclusion Criteria:

* Patients who are terminal ill which means having a life-limiting disease with irreversible decline and who are actively dying (actively dying is related to patients with days of survival). (41)
* Having cognitive impairment
Potential Beneficial Effects of Resveratrol

We want to investigate whether the food supplement resveratrol is able to counteract the detrimental effects of obesity.

The aim of this study is to investigate potential metabolic effects of resveratrol in healthy but obese men. We hypothesize that resveratrol will counteract some of the detrimental effects of obesity, and as an imitator of calorie restriction will give new insight into the basic biochemical pathways underpinning human metabolism. Of special interest is the potential connection between resveratrol, calorie restriction, SIRT1, STAT5b and the GH/IGF-I axis.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 kg/m2
* Otherwise healthy
* Written informed consent

Exclusion Criteria:

* Any disease
* Alcohol dependency
* Allergy to trial medication
* Present or previous malignancy
* Participation in other clinical trials within three months before randomization
Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)

The purpose of this study is to assess the feasibility of SafeLM as a primary airway device and as a conduit for intubation with and without the use of a bougie


Eligibility Criteria:
Inclusion Criteria:

* elective surgery requiring general anesthesia and airway management using a supraglottic airway device or endotracheal intubation

Exclusion Criteria:

* pregnancy
* known or suspected difficult airway management
* history of oropharyngeal or upper airway surgery
* known or suspected airway or respiratory pathology, such as significant obstructive sleep apnea or chronic obstructive pulmonary disease (COPD)
* BMI greater than 40 kg/m2
* unable to undergo intubation via the oral route
* known or suspected full stomach or other risk factors for aspiration
* contraindication for the use of neuromuscular blocking agents
* history of significant gastroesophageal reflux disease (GERD)
* Vulnerable populations (cognitively impaired persons, prisoners)
Observational Study in Type 2 Diabetics Treated by an Intensive Insulin Treatment of Levemir®

This study is conducted in Europe. The aim of this observational study is to gain practical experience with once daily Levemir® administration in type 2 diabetes patients who were previously treated with NPH insulins (e.g. Protaphane®) as basal insulin as part of their IIT under normal clinical practice conditions in Lithuania


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic subjects on intensive insulin treatment (IIT)
* Eligibility for once daily insulin detemir administration
* Informed consent obtained before any observation-related activities

Exclusion Criteria:

* Known or suspected allergy to insulin detemir
* Subjects previously enrolled in the observation
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within 6 months
11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension

This study is looking at differences in metabolism and functional imaging between pulmonary hypertension subjects with normal right ventricular function and persistent right ventricular dysfunction.

We will measure right ventricular metabolic and structural changes using serial 11C-acetate and 18F-FDG PET/CT and cardiac MRI as response to treatment with ranolazine. Subjects undergo imaging procedures at week 0 and week 26 (optional for normal function patients). This is a companion imaging trial for patients who are eligible for the treatment trial entitled "A randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction". Subjects must enroll in companion treatment protocol to qualify for the imaging protocol.

The cardiac MRI portion of the study continued, but the PET portion of the study was discontinued due to funding.

The treatment protocol is registered under: NCT01839110. Due to funding issues, the completed study was registered under NCT02829034.

Eligibility Criteria:
Inclusion Criteria:

Participation in the companion treatment protocol "A randomized, double-blind, placebo controlled, multi-center study to assess the effect of ranolazine on outcomes in subjects with pulmonary hypertension and right ventricular dysfunction accompanied by a comparative study of cellular metabolism in subjects with pulmonary hypertension with and without right ventricular dysfunction"

Exclusion Criteria:

* Pregnancy or lactation: Women of childbearing potential must have a negative urine or blood pregnancy test on the day of the PET/CT scan.
* Severe anxiety or claustrophobia prohibiting completion of imaging
* Inability to tolerate imaging procedures (1 hour MRI, 30 min and 15 min PET)
* Implantable cardioverter-defibrillator, Pacemaker, hazardous metallic implants or any other contraindication to MRI.
* Uncontrolled diabetes mellitus with fasting glucose \> 150 mg/dL
Does the Enhanced Rehabilitation Programs Facilitate the Motor Recovery After Stroke?

Study purpose This study will explore whether an additional rehabilitation program that focus on either upper or lower extremity training facilitate the recovery in upper or lower extremity.

The recovery in both neurological status and motor functions will be explored.

Design A single-blinded (assessor-blinded) randomized controlled trial. Interventions The participants will be randomly assigned into two experiment groups (enhanced upper extremity program; and enhanced lower-extremity program).

Both groups receive routine rehabilitation including daily 50 mins of physical therapy and 50 mins of occupational therapy.

The enhanced upper extremity program group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity, while the enhanced lower-extremity program group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity. The participants receive 20-day training over a 4-week period. The additional program is designed to be specific to either upper-extremity or lower-extremity. Accordingly, one group can be used as the control group of the other one.

Eligibility Criteria:
Inclusion Criteria:

1. First-ever stroke with the onset 10-90 days prior to the enrollment
2. Age: 20-80y
3. With a hemiplegic upper extremity with Brunnstrom stage in I\~IV
4. Able to understand simple orders (1-step orders, such as "raise your hand, touch your head....)
5. Totally independent in activity of daily life before the onset of stroke

Exclusion Criteria:

1. Incompliance to the assessments or interventions due to unstable medical condition, abnormal cognition, or other conditions.
2. Stroke of brainstem or cerebellum
3. Had received craniotomy or ventriculoperitoneal shunting
4. Needs of orthoses in walking before the onset of stroke
5. Had had motor dysfunctions (eg, amputation, cerebral palsy, poliomyelitis or other neuromuscular diseases) before the stroke.
6. Intracranial hemorrhage caused by artereovenous malformation, aneurysm, or tumor
7. Able to walk independently for more than 50 meters.
PROMs To Improve Care- Standardized vs Patient Specific

To examine the impact of using 2 validated PROMs during the care of an orthopaedic condition on shared decision making, patient centered care, and patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* hand surgery patients over age 18, english fluency and literacy, able to take informed consent

Exclusion Criteria:

-
Pilot Study of Elemene in Treating Patients With Refractory Glioblastoma

This is a pilot phase I study to evaluate the safety and efficacy on elemene injectable emulsion in treating patients with glioblastoma. Elemene, isolated from the Chinese medicinal herb Curcuma wenyujin, was shown to exhibit antitumor activity in human and murine tumor cells in vitro and in vivo.Elemene injectable emulsion against malignant tumors was low. Therefore, the effect of Elemene injectable emulsion being used in clinical settings needs to be confirmed by further RCTs.

Background

* Elemene, isolated from the Chinese medicinal herb Curcuma wenyujin, was shown to exhibit antitumor activity in human and murine tumor cells in vitro and in vivo
* The study shows that the methodological quality of RCTs of Elemene injectable emulsion against malignant tumors was low. Therefore, the effect of Elemene injectable emulsion being used in clinical settings needs to be confirmed by further RCTs

Objectives

* To evaluate the safety of Elemene injectable emulsion to treat Refractory Glioblastoma with TMZ
* To evaluate the efficacy of Elemene injectable emulsion to treat Refractory Glioblastoma with TMZ

Design

This clinical trail is a randomized controlled trial.In control group,patients will receive TMZ-chemotherapy.In experimental group,patients will receive elemene injectable emulsion and TMZ-chemotherapy at the same time.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years; Male or Female.
2. Relapsed/refractory disease confirmed by radiographic evidence after standard therapy.
3. KPS ≥ 60
4. ≥ 8 weeks after completion of front-line radiation therapy
5. ≥ 6 weeks after completion of nitrourea chemotherapy
6. ≥ 14 days after completion of Temozolomide or other chemotherapy
7. 2 weeks of wash-out time after completion of targeted therapy with related adverse events (AE) on baseline
8. White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%.
9. Echocardiographic assessment of left ventricular ejection fraction (LVEF) ≥ 40% within 1 month of enrollment.
10. Patients must be able to understand the investigational nature of the study and provide informed consent.

Exclusion Criteria:

1. Those who are allergic constitution, or have contraindications to CT and MRI1 contrast agents.
2. Those who plan to receive any other anti-tumor treatment during the trial.
3. Combined with serious primary diseases of cardiovascular, liver and kidney, and liver function (ALT, AST, Y-GT) exceeding 1.5 times of the upper limit: BUN or Cr exceeding 1.5 times of the upper limit of normal value.
4. Patients with other malignant tumors.
5. Those with active infections, etc.
6. Suspected or confirmed a history of alcohol and drug abuse.
7. Psychiatric illness, intellectual and language disabilities that compromise the informed consent process, at the discretion of the investigator.
8. Women who are pregnant or nursing.
9. Women of childbearing age who refuse to contraception.
10. Active participation in another clinical treatment trials.
11. According to the judgment of the investigator, other conditions that the plan cannot be followed.
Normal Saline vs Hypertonic Saline in the Treatment of Bronchiolitis

Background: Bronchiolitis is one of the most common and costly respiratory diseases in infants and young children. Despite the high prevalence and morbidity of bronchiolitis, therapy remains controversial. Supportive care ensuring adequate hydration and oxygenation remains the cornerstone of therapy for these infants.

Over the past 2 decades, research on bronchiolitis management has explored the use of nebulized hypertonic saline that rehydrate the airway surface liquid and improve mucociliary clearance, as well as reduce airway edema.

Aim:The aim of this study is to investigate whether the addition of frequently nebulized hypertonic saline to standard therapy affects the length of stay (LOS) of moderately ill infants hospitalized with bronchiolitis.

The investigators will conduct this prospective double blind randomized clinical trial by comparing between 2 groups of patients with bronchiolitis, first group will receive 3% hypertonic saline and second group will receive 0.9% saline.

Data collection includes:

Name, Age, Mode of delivery, Birth weight, Current weight, Number of sibling, Immunization record, Duration of breast feeding, past medical history including number of wheezy chest, pneumonia, Parents level of education, Presence of Asthma / Allergic rhinitis in family, Pets /Smoke at home)

Using the validated Respiratory Distress Assessment Instrument (RDAI) investigators will assign patients a score before and at the end of treatment.

To prepare 3% sodium chloride, the investigators will dilute 60 ml 20% sodium chloride injection with 500 ml normal saline (NSS) 0.9%.

Length of stay will be measured in both groups, to establish the efficacy of hypertonic saline in reducing length of stay.

Eligibility Criteria:
Inclusion Criteria:

* Infants up to 24 months of age with diagnosis of acute bronchiolitis
* In accordance with 2006 American Academy of Pediatrics (AAP) definition of bronchiolitis,we did not limit to the first episode of wheeze
* Patients with the diagnosis of bronchiolitis

Exclusion Criteria:

* Chronic lung or heart disease (hemodynamically significant cardiac disease, chronic lung disease / bronchopulmonary dysplasia requiring diuretics or oxygen)
* Cystic fibrosis, trisomy 21, immunodeficiency / transplant recipient, neuromuscular disease
Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause

The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause in women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA.


Eligibility Criteria:
Inclusion Criteria:

* Subject is postmenopausal.
* Subject has moderate to severe vaginal dryness as the self-reported MBS of VVA.

Exclusion Criteria:

* Subject has clinically significant abnormal findings in the physical examination.
* Subject has a body mass index (BMI) equal to or greater than 38 kg/m\^2
* Subject has uncontrolled hypertension.
* Subject has clinically significant abnormal findings in the gynecological examination other than signs of vaginal atrophy.
* Subject has uterine/vaginal bleeding of unknown origin.
* Subject has a vaginal infection requiring medication (may be treated and be eligible for study).
A Study of Single Dose of ABT-333 in Healthy Male Adults

The objectives of this study is to assess the safety, tolerability, and pharmacokinetics of blind, escalating, single, oral doses of ABT-333 under nonfasting conditions in healthy male adult in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Subject has provided written consent.
* Subject is in general good health.

Exclusion Criteria:

* See above for main selection criteria.