cyrilzakka/clinical-trials huggingface dataset:
Pazopanib in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib

Patients with metastatic or locally advanced gastrointestinal stromal tumors (GIST) who develop resistance against the two hitherto approved drugs for this disease, the tyrosin kinase inhibitors (TKIs) imatinib and sunitinib, have a poor prognosis. Sometimes a further response may be achieved by other drugs, mainly other TKIs, which have been explored in different studies but not yet have been approved for clinical use. Pazopanib is a TKI inhibiting the tyrosin kinases KIT, PDGFRA, and VEGF 1-3, all of which have important roles in the pathogenesis of GIST. Theoretically, it may function in GIST, and it deserves investigational trials. The drug is approved for metastatic renal cancer and is relatively well tolerated. In this trial (SSG XXI), the disease control rate (DCR) = (CR+PR+SD) after 12 weeks of treatment will be assessed as the primary endpoint, and at the same time trough levels will be measured. Secondary endpoints include ORR, PFS, toxicity, and disease control rate in relation to trough level week 12 and in relation to the primary mutation of the tumor (if known). The goal is to include 72 patients in the trial, which is open and single arm.


Eligibility Criteria:
Eligibility Criteria:

* Metastatic and/or locally advanced GIST, with diagnosis based on histology with positive c-kit and/or DOG-1, or with a GIST-typical mutation in KIT or PDGFR
* Measurable disease on CT (computed tomography) as defined by RECIST criteria; at least one measurable lesion not given radiotherapy
* History of progressive disease on CT according to RECIST criteria after both imatinib and sunitinib treatment, and also after nilotinib if this drug has been given
* No other TKIs given than imatinib, sunitinib and nilotinib
* Age at least 18 years at the time of diagnosis of GIST
* WHO performance status 0-2
* Resolution of all toxic side effects from earlier TKI treatment and any other potential non-TKI treatment to grade 1 or below
* Sufficient organ functions as defined in the protocol
* Absence of earlier or present certain other conditions as defined in the protocol
* No pregnancy or lactation
* Women with childbearing potential must accept the use of adequate contraception throughout the study period
* Written informed consent
Glycaemic Alterations in ICU

To quantify the local prevalence of diabetes mellitus in critically ill patients. To understand whether a correlation does exist between premorbid glycaemic control and glycaemic status in ICU. A subgroup analysis will be conducted to investigate whether a relationship does exist between Neuron Specific Enolase levels and glycaemic disorders.

The aim of this study is to determine the local prevalence of critical illness-associated hyperglycaemia (CIAH) and recognised and unrecognised diabetes, as well as to evaluate how premorbid glycaemia impacts the relationship between three glycaemic domains and mortality.

The investigators will calculate the Time In Range (TIR, 70-180 mg/dl) and evaluate distribution of percentage time in range for non-diabetics and diabetics patients, in order to understand the association between TIR and survival in both groups of patients (patients with diabetes and patients without diabetes).

In view of the potential adverse effects of hyperglycaemia, hypoglycaemia and glycaemic variability on the brain, the investigators will dose Neuron Specific Enolase in critically ill patients.

The aim is to define if a biochemical correlation does exist between critically ill dysglycaemia and NSE plasma concentration.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients
* expected ICU length of stay \> 48 hours

Exclusion Criteria:

* age \<18 years
* ICU length of stay \<48 hours
* diabetic ketoacidosis
* hyperosmolar nonketonic hyperglycaemia syndrome
* pregnancy
* hypoglycaemic coma
* acute or acute on chronic liver failure, liver transplantation or end-stage liver disease.
Interferon Pathway Activation in Monogenic and Nonmonogenic Forms of Pediatric SLE

Pediatric SLE includes monogenic forms, some of which involve the interferon type I (IFN-I) pathway. The IFN-I pathway is renally active in adult SLE and correlates with the extent of renal damage. In pediatric SLE, and particularly in lupus nephritis, activation of the IFN-I pathway has never been studied, nor is it known whether monogenic forms underlie more pronounced interferon activation.

Pediatric systemic lupus erythematosus (SLE) (cSLE), compared with adult SLE, is characterized by a more severe phenotype, with more marked hematologic, neuropsychiatric, and renal changes. Lupus nephritis is a pivotal manifestation of pediatric SLE and an important prognostic factor. It is hypothesized that activation of the interferon pathway is more pronounced in monogenic forms, in which the response to IFN-I represents the primary alteration and likely the main pathogenic mechanism.

This finding may also be relevant in light of the availability of new drugs that selectively target the IFN-I pathway.

Demonstration of IFN-I pathway activation could be used as a diagnostic algorithm in aggressive pediatric forms resistant to immunosuppressive therapy and represent a therapeutic target.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SLE arising before the age of majority (until the age of 18 years) according to SLICC and/or EULAR criteria 2019;
* Clinical, laboratory and/or histologic evidence of renal involvement manifested before the age of 18 years;
* Signature of informed consent.

Exclusion Criteria:

* Onset of renal disease after the age of 18 years;
* SLE secondary to drugs or associated with other diseases such as systemic sclerosis, rheumatoid arthritis, Sjögren's syndrome, and other connectivities.
The Impact of COVID-19 Pandemic on Cancer Care

The situation of COVID-19 pandemic creates many challenges for cancer patients and caregivers. Some modifications in cancer management have been evolved from cancer societies and organizations to support oncology professionals as much as possible to deliver optimal care to their cancer patients in such exceptional circumstances, and to protect patients from infection with COVID-19 as much as possible.

In oncology practice during this pandemic, many cancer patients still feeling uncertainty about their cancer management and treatment outcome . The study is aiming to better understand the impact of the COVID-19 pandemic on cancer care from patients' and survivors' perspective.

Eligibility Criteria:
Inclusion Criteria:

* cancer patients or survivors in Egypt.

Exclusion Criteria:

* No exclusion criteria
Substance Consumption, Personality, and Cognitive Functioning of Chess Players

The aim of this project is to find out if there is a difference in addictive behavior, personality traits, and cognitive abilities between chess players and non-chess players.

In the present planned study, tournament chess players will be compared with non-tournament chess playing individuals by means of an online survey. Among other things, the investigators want to investigate whether these groups of persons differ in various characteristics such as their consumption behavior (alcohol, tobacco, and drug use), their personality, their depressiveness and mood, or their cognitive abilities. The background is the question whether playing chess could be protective against substance use disorders or could mitigate the manifestation.

Eligibility Criteria:
Inclusion Criteria:

* all persons from the age of 18 years
* Inclusion in the group of chess players is based on the existence of a DWZ.
* Sufficient ability to answer the questionnaires

Exclusion Criteria:

* None
Absolute Bioavailability of a Single Oral Dose of Selexipag in Healthy Subjects

The primary purpose of this phase 1 study is to investigate the absolute bio-availability of a single oral dose of selexipag, i.e., to assess the amount of selexipag which reaches the blood when administered as an oral tablet (ACT-293987) compared to an intravenous administration in healthy subjects.

A pilot phase was conducted in 3 male subjects before the main phase for assessment of absolute bio-availability conducted in 16 other male subjects. The pilot phase aimed to determine the intravenous dose to be used in the main phase based on safety data and pharmacokinetics data.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure
* Aged from 18 to 45 (inclusive) at screening
* Body mass index (BMI) from 18.0 to 28.0 kg/m2 (inclusive) at screening
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests

Exclusion Criteria:

* Any contraindication to the study drug formulations
* History or presence of any disease or condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study drugs
* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol
Injection Management With Betaferon: Influence on Adherence, Patients Satisfaction and Health Related Outcomes (BETAPATH)

Aim of the BETAPATH study is to evaluate whether the use of a personal digital assistant (PDA) can improve the adherence of Multiple Sclerosis patients to a therapy with Betaseron. The Personal digital assistant PDA functions as an electronic diary and as an injection reminder.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with the diagnosis of Multiple Sclerosis and decision by the investigator to prescribe Betaferon.The decision for treatment type and duration is taken before offering the patient the possibility to participate in the study.

Exclusion Criteria:

* Patients, who do not meet the Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis (RRMS) criteria, should not be included.
* Exclusion criteria must be read in conjunction with the German product information.
Switching to Iloperidone From Other Antipsychotics in Schizophrenia

Evaluate the clinical outcome of two switching strategies to iloperidone treatment in adult subjects with schizophrenia who require a change in their current antipsychotic treatment of risperidone, olanzapine, or aripiprazole due to suboptimal efficacy and/or safety/tolerability reasons.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, 18 to 64 years of age, inclusive
* DSM-IV diagnosis of schizophrenia
* Patients currently on an optimal in-label dose of one of the following permitted antipsychotic treatments for at least 30 days: risperidone, olanzapine, or aripiprazole
* Efficacy Clinical Global Impression of Severity (E-CGI-S) of 4 or 5 or
* Not tolerating one of the permitted treatments and exhibits one of the allowable side-effects

Exclusion Criteria:

* Any other current Axis I disorder other than schizophrenia which is the focus of treatment;
* Acutely psychotic or patient's symptom severity requires hospitalization
* Patient with significant cardiovascular illness (myocardial infarction, cardiac arrhythmia)

Other protocol-defined inclusion/exclusion criteria may apply
Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents

This study will be conducted to evaluate the safety and efficacy of sumatriptan nasal powder (AVP-825) compared to placebo in the acute treatment of migraine in adolescent participants, 12 through 17 years of age.

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating AVP-825 for the acute treatment of migraine with or without aura in adolescent subjects (12 to 17 years old).

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants 12 to 17 years (inclusive) of age at the time of informed consent
* Have a diagnosis of episodic migraine with or without aura according to International Classification of Headache Disorders-Third edition, beta version (ICHD-IIIB, 1.2.1 or 1.1) criteria, for at least 1 year prior to the screening/enrollment visit
* Experienced migraine attacks of moderate-to-severe intensity and typically lasting ≥ 3 hours untreated, occurring at a frequency of ≥ 2 to ≤ 14 attacks per month for the past 6 months prior to the screening/enrollment visit
* Participant's parent or legal guardian must be willing to sign a copy of the informed consent form as well as documentation for Written Authorization for Use and Release of Health and Research Study Information, after the nature and risks of study participation have been fully explained. Participants must be willing to provide informed assent.

Exclusion Criteria:

* Participants with ≥ 15 headache days per month in total (migraine, probable migraine, or tension-type)
* Participants with the following headache types: retinal (ICHD-IIIB, 1.2.4), with brainstem aura (ICHD-IIIB, 1.2.2), hemiplegic (ICHD-IIIB, 1.2.3), status migrainosus (ICHD-IIIB, 1.4.1), other forms of complicated migraine, or secondary headaches
* Participants who have not responded to an adequate dose and appropriate duration of treatment with 2 or more triptans
* Participants with known nasal obstruction, current uncontrolled nasopharyngeal illness, or known velum insufficiency (i.e., a cleft palate and/or structural abnormalities in the soft palate and nasopharynx) that may interfere with the proper use of study medication
* Participants whose conditions in the investigator's opinion may put the participant at significant safety risk or confound the study results. This includes participants who in the investigator's opinion should not be enrolled in the study due to the risks described in the Warnings and Precautions or Contraindications sections of the ONZETRA Xsail Prescribing Information.
Bone Graft Particle Size on Bone Vitality and Volume

To determine the effects of small and large bone graft particles vs large particles alone on percent vital bone, percent residual graft material, measured histologically from bone biopsies of the grafted site taken at the time of dental implant placement from subjects undergoing sinus augmentation for the placement of dental implants. Dental radiographs taken post operatively will be used to estimate bone graft volume differences between conditions.

The proposed study is a Randomized, single-masked, split-mouth, single center study.

About 20 subjects will be screened in order to randomize 10 study subjects. 10 patients who needing bilateral sinus augmentation procedure using the lateral window technique will be randomized using computer generated randomized technique.

At the day of the surgical procedure each tooth sites will be randomized 1:1 into one of the following bone grafts to either the right or left side of the mouth.:

* Bone graft A: A mixture of 25% small-particle cortical allograft, 25% large-particle cortical allograft, 25% small-particle cancellous allograft, and 25% large-particle cancellous allograft is used for one sinus (N=10)
* Bone graft B: 100% large particle cancellous allograft for the contralateral sinus (N=10) Immediately after the sinus augmentation surgery a CBCT will be acquired and will be compared to a second CBCT prior to implant placement in order to compare the volumetric changes in the sinus.

At the visit of implant placement, a bone core will be collected from both sinuses for histomorphometric evaluation to evaluate the residual graft particles, the new vital bone formation and the amount of soft tissue components.

Eligibility Criteria:
Inclusion Criteria:

* Good physical health
* Capable of maintaining good oral hygiene
* Missing posterior maxillary teeth on both sides and less than 5 mm of residual jaw bone requiring maxillary sinus augmentation prior to dental implant placement
* Capable and willing to give informed consent

Exclusion Criteria:

* The presence of underlying medical conditions that may pose an undue risk for sinus surgery
* Patients with untreated oral infections
* Pregnant and lactating females
* Individuals who have the habit of smoking and/or tobacco chewing
* Patients not willing to participate in the study
Acute Effects of Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects

This study aims to investigate the effect of spices on gene expression of pathways associated with glucose homeostasis, oxidative stress and inflammation, in the postprandial phase in healthy human subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females
* BMI 20-28 kg/m2
* Must be able to accept spices
* Agreed and signed informed consent

Exclusion Criteria:

* Below 18 years old
* Uncomfortable speaking English and/or difficulties in understanding spoken English
* Smoking or using snuss
* Vegetarian or vegan
* Stressed by venous blood sampling or previous experience of being difficult to be cannulated
* Receiving any drug treatment that may influence the study outcomes
* Pregnancy or breastfeeding
Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability

To assess next day driving ability and psychomotor/memory function following a single night time dose of eszopiclone in insomnia patients.

The study is a single centre, randomised, double blind, placebo controlled 2-way crossover design in a group of 32 male and female primary insomnia patients. The medications under investigation are eszopiclone and placebo. Patients will receive the study medications and placebo on the evening of Day 2 of each treatment period. Performance will be assessed on Day 3 of each treatment period. Each treatment period will be separated by at least a 7-day washout period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 55 years inclusive
* In good health as determined by a medical history, ECG, haematology, blood and urine biochemistry and physical examination by the doctor
* Diagnostic and statistical manual of mental disorders, defined primary insomnia
* A body mass index greater than or equal to 18 and less than or equal to 30
* Registered with a general practitioner (GP)
* Hold a full current driving licence for at least one year, and be regular car drivers

Exclusion Criteria

* The use of any other medication during the study with the exception of oral, transdermal, IUDs (progestogen only contraceptive e.g. Mirena), or depot contraceptives, non-steroidal analgesics (e.g. ibuprofen), and paracetamol. A 7-day washout period is required for any patient currently receiving prescription or non-prescription sleep medication.
* Diagnosed sleep disorder or confirmed symptoms other than primary insomnia (e.g. restless leg syndrome, sleep apnoea)
* Significant history of mental illness, significant drug allergy, malignancy or chronic drug abuse (including alcohol)
* Any subject with known hypersensitivity to any of the study treatments
* A sleep/wake cycle other than primary insomnia (e.g. shift work) liable to prejudice the results of the study
* Pregnant or lactating females, and females of child bearing potential not using effective contraception
* Patients who habitually smoke more than 5 cigarettes per day
* Caffeine consumption of more than 5 cups or glasses per day
* History of alcohol or drug dependence or intake of more than the equivalent of 14 units of alcohol per week for females and 21 units per week for males
* Current participation in another clinical trial, or participation in a clinical trial within the last 90 days
Optical Coherence Tomography of Retinal Abnormalities Associated With Choroidal Nevus, Choroidal Melanoma and Choroidal Melanoma Treated With Iodine-125 Brachytherapy

During regularly scheduled appointments, Optical Coherence Tomography (OCT) is performed on consented subjects. The OCT is a new type of camera that takes very detailed pictures inside of the eye and deeper into eye tissues. Optical Coherence Tomography imaging of intraocular tumors may lead to improved diagnosis and monitoring of tumors within the eye.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older) with:

  * choroidal nevus greater than or equal to 3.0 mm in longest basal diameter, or greater than or equal to 1.25 mm in apical height or:
  * choroidal melanoma located in the posterior pole (4mm or less from the center of fovea or the border of the optic nerve head)

Exclusion Criteria:

* Ocular media opacity in the tumor eye that prevents adequate functional testing or imaging and prior or concurrent retinal or choroidal disease in the tumor eye that prevents adequate functional testing or imaging
The Effect of Green Tea or Cocoa Extracts in Endothelial Dysfunction in Patients With Diabetes Mellitus

The purpose of this study is to determine whether green tea or cocoa extracts are effective in improve endothelial dysfunction in patients with diabetes mellitus and nephropathy and arterial hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes mellitus
* Diabetic nephropathy
* Hypertension

Exclusion Criteria:

* GFR \< 30 ml/min/1.73m2
* Serum K \> 5.5 mEq/L
* Age \< 18 y
* Pregnancy
* Breast feeding
* Cocoa or green tea intolerance
* Alcohol and drugs abuse
* Incapacity to understand the information related to the study