cyrilzakka/clinical-trials huggingface dataset:
A Randomised Trial Investigating the Additional Benefit of Hydroxychloroquine(HCQ)to Short Course Radiotherapy (SCRT) in Patients Aged 70 Years and Older With High Grade Gliomas (HGG)

There is emerging evidence that hydroxychloroquine (HCQ), a drug used commonly in the prevention/ treatment of malaria, rheumatoid arthritis and lupus erythematosus, may improve survival outcome in a variety of cancers including HGG, with few side effects.

In this trial the investigators wish to investigate whether treatment with radiotherapy and hydroxychloroquine is more effective than treatment with radiotherapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged ≥70 yrs identified through the neurooncology MDT.
* A histological diagnosis of HGG, either from biopsy or resection.
* A life expectancy of \> 2 months
* An ECOG performance status of 0/1
* Absolute neutrophil count ≥ 1.5 x 109
* Platelet count ≥ 100 x 109
* Bilirubin ≤ 1.5 mg/dL (or ≤ 25.6 µmol/L)
* Creatinine ≤ 2 times upper limit of normal (ULN)
* ALT and AST ≤ 4 times ULN
* Mini Mental Status Exam score ≥ 17 (Appendix 10)
* Written informed consent
* Ready to start radiotherapy within 4 weeks of surgery

Exclusion Criteria:

* Concurrent psoriasis unless the disease is well controlled and patient is under the care of a specialist for the disorder who agrees to monitor for exacerbations
* Prior macular degeneration or diabetic retinopathy
* Concurrent serious infection or medical illness that would preclude study therapy
* Another malignancy within the past 5 years except for curatively treated carcinoma in situ or basal cell carcinoma of the skin
* Porphyria
* Glucose- 6 phosphate dehydrogenase (G6PD) deficiency
* Alcoholic liver disease
* Any other concurrent severe/uncontrolled medical conditions
* Currently taking amiodarone
* Prior radiotherapy, chemotherapy, immunotherapy, biologic agents (e.g., immunotoxins, immunoconjugates, antisense agents, peptide receptor antagonists, interferons, interleukins, tumour-infiltrating lymphocytes, lymphokine-activated killer cell therapy, or gene therapy), or hormonal therapy for brain tumour
* Prior polifeprosan 20 with carmustine implant (Gliadel wafer) or GliaSite® brachytherapy
* Concurrent cytochrome P450 enzyme-inducing anticonvulsant drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine)
* Other concurrent chemotherapeutic or investigational agents for this cancer (Concurrent glucocorticoids will be allowed
* Documented side effects to chloroquine or related agents.
* Unable to give informed consent
* Patients with a history of a psychological illness or condition that in the opinion of the investigator may adversely affect compliance with study medication
Study of Novel Types of Familial Diabetes Insipidus

OBJECTIVES:

I. Define the phenotype and genotype of previously unrecognized types of familial diabetes insipidus (FDI) in kindreds with atypical or novel forms of FDI.

PROTOCOL OUTLINE: Participants undergo a series of tests to determine the presence, absence, cause, natural history, clinical status, and mode of inheritance of their type of diabetes insipidus (DI). The studies include measurements of basal fluid intake and urine output, plasma vasopressin during standard fluid deprivation or waterload/saline infusion tests, and changes in water balance during a therapeutic trial of DDAVP. If clinically indicated, echocardiograms and assays of plasma catecholes and renin are also completed.

Linkage analysis is performed for all participants; kindreds with the Marfan-like syndrome are also studied for the fibrillin-1 genotype.

Participants determined to have DI are treated with desmopressin for 2 days.

Eligibility Criteria:
* Familial diabetes insipidus (DI) in atypical or novel form, e.g.: Dipsogenic DI Neurohypophyseal DI
* Affected and unaffected members of kindreds eligible
Anemia and Pneumonia

Assess prevalence of anemia among pneumonic children aged two months up to two years.

Pneumonia is an infection via one or both lungs . bacteria and viruses are the most common causes. pneumonia can be medical emergency especially among high risk group like children less than five years Iron deficiency anemia is one of the major health problem in young children. It may be associated with increased risk of pneumonia (1).

A study conducted by Bhaskaram reported high frequency of anemia 83 % in children with pneumonia (2). Iron functions in the immune system are essential, among which are included: the maintenance of the activity of phagocyte oxidase, an iron excess can be used by bacteria to improve its growth (3). Anemia was found to be independently associated with fatal outcome in pneumonic children (4). The risk of development of pneumonia in children with anemia increases approximately by four times in comparison with children who have no anemic syndrome (5).

Breast-feeding protects against lower respiratory tract infection because of breast milk's unique antiinfective properties (6). Infants who were not being breast fed were 17 times more likely than those being breast fed without formula milk to be admitted to hospital for pneumonia (7). one of the factors that affects severe malnutrition is wrong parenting as parents can play an important role in their children's growth through proper, adequate feeding (8). There's no available studies that examine the association between anemia and pneumonia in our locality.

Eligibility Criteria:
Inclusion Criteria:

1. Inclusion criteria: Children aged two months up to two years who attend to Assiut University Hospital with pneumonia in the outpatient pediatric clinic, emergency unit and from inpatient .

Exclusion Criteria:

* . Exclusion criteria: All patients with other comorbidities will be excluded from our study as: severe sepsis \& localized infection e.g endocarditis, empyema, autoimmune diseases,renal diseases and congenital anomaly
The Analgesic Effect of Intrathecal Hydromorphone Injection on Spinal Anesthesia

The purpose of this study is to evaluate the adequate dose of intrathecal hydromorphone injection for postoperative pain relief after knee arthroscopic surgery.

Sixty patients who were undergoing unilateral knee arthroscopy randomly received unilateral spinal anesthesia with 0.5% hyperbaric bupivacaine 6 mg combined with normal saline 0.05 mL or hydromorphone 2.5, 5 or, 10 μg/0.05 mL. The verbal numerical rating scale (VNRS) pain scores were measured at 30 minutes and 2, 4, 6, 12 and 24 hours postoperatively, and the side effects of hydromorphone were recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA class I-II (age range: 18-72 years)
* Informed consent obtained patients

Exclusion Criteria:

* The exclusion criteria included evidence of neurological or neuromuscular disease, respiratory or cardiac disease, diabetes mellitus or peripheral neuropathy, as well as those patients who were receiving chronic analgesic therapy or who had infection at the intended site of spinal needle insertion or who had hypersensitivity to amide local anesthetics or opioids
Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T Therapy

The aim of this study is to evaluate the feasibility of a digital health coaching program for, and to describe quality of life of, individuals in the 6 months following chimeric antigen receptor (CAR) T cell therapy. Up to 50 English-speaking individuals aged 18 and older who are to receive treatment with a CAR T cell therapy will be enrolled, all at The University of Texas MD Anderson Cancer Center. Participants must have internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments and will be excluded if they are unable to provide informed consent or have a prognosis of 6 months or less.

Consented participants will be enrolled in a 6-month digital health coaching program delivered via weekly calls from a Health Advisor coupled with the digital delivery of content. The program focuses on identification and escalation of treatment-related toxicity, communication with providers, and physical and psychosocial health following treatment. Health related quality of life (HRQoL) will be assessed with the Functional Assessment of Cancer Therapy-Lymphoma (FACT-L), health self-efficacy will be assessed by the Cancer Behavior Inventory-Brief (CBI-B), physical and mental health outcomes will be measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health 10. Patient experience in managing CAR T specific care will be assessed with a 5-item questionnaire developed specifically for use in this study, focused on participants' confidence in understanding, identifying and managing symptoms, and communicating with providers. Study outcomes will contribute to knowledge about if and how a digital health intervention may be used to support individuals post-CAR T cell therapy.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and older
* Able to read, speak and consent in English
* Confirmed treatment with any commercially available or investigational CAR T cell therapy.
* Internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments.
* Ability to engage in physical activity as evidenced by an Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to 2

Exclusion Criteria:

* Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment)
* Individuals for whom there is documentation of inability to provide consent in the medical record.
* Non-English speaking/reading individuals.
Comparison of Two Growth Hormone Dosing Methods in Adults With Growth Hormone Deficiency

This study tested whether a dose regimen of growth hormone based on body weight is equivalent or better than starting with a low dose and gradually increasing the dose according to individual patient needs. Efficacy of the two regimens were assessed from changes in body fat measured by dual-energy x-ray absorptiometry (DXA) scanning, performed at the beginning of the study and at the completion of the study eight months later.

Dose regimen of growth hormone based on weight: Starting dose was 4.0 micrograms/kg/day for four months, then increased to 8 micrograms/kg/day for two months, and then increased to 12 micrograms/kg/day for a further two months (eight months in total).

Dose regimen of growth hormone based on individual patient needs: Starting dose was 200 micrograms/day, then increased by 200 micrograms/day every two months for an additional six months (eight months in total) as needed for optimal treatment results.

Eligibility Criteria:
Inclusion Criteria:

* Have growth hormone deficiency that started in childhood or adulthood
* Have not received any growth hormone treatment in the last 12 months
* Have had a growth hormone stimulation test within the last two years showing abnormally low response
* Have received adequate and stable hormonal replacement for other hormone deficiencies during the last three months

Exclusion Criteria:

* Presence of clinically significant diseases, such as cancer, lung, heart, liver, kidney, neuromuscular, genetic, or severe psychiatric diseases
* Recent growth of pituitary tumor or other intracranial tumor
* History of acromegaly
* Taking medication to suppress appetite or reduce weight, or antidepressant drugs
* Poorly-controlled high blood pressure or diabetes
A Study of Selexipag in Healthy Male Participant

The purpose of this study is to evaluate the pharmacokinetic (PK) of selexipag and ACT-333679 following single oral administration of the matrix tablet and the encapsulated pellets of selexipag, each with 3 different release profiles, as compared to selexipag immediate release (IR) tablets in healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
* Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participants may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
* Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for, the study and is willing to participate in the study
* Body mass index (BMI; weight (kilogram \[kg\]/height\^2 \[meter {m}\]\^2) between 18.0 and 28.0 kilogram per square centimeter (kg/m\^2) (inclusive), and body weight not less than 50.0 kg at screening
* Blood pressure (after the participant is supine for 5 minutes) between 90 and 145 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening. If blood pressure is out of range, up to 2 repeated assessments within the screening period are permitted, last assessment being conclusive

Exclusion Criteria:

* Clinically significant abnormal values for hematology, biochemistry, or urinalysis at screening and on Day -1 of Treatment Period 1 as deemed appropriate by the investigator
* Known allergies, hypersensitivity, or intolerance to selexipag or its excipients
* Any contraindication included in the Summary of Product Characteristics (SmPC) of selexipag
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study treatments (appendectomy and herniotomy allowed, cholecystectomy not allowed)
* Previous history of stroke, fainting, collapse, syncope, orthostatic hypotension, vasovagal reactions, head injury
Effect of Dash Diet and Acupuncture on Hypertention in Postmenopausal Women

A study of effect of dash diet and acupuncture on hypertension in postmenopausal women

45 of post menopausal women divided into three groups A,B,C

* Group (A): It will include 15 post-menopausal women who will be treated by DASH diet and anti-hypertensive drugs.
* Group (B): It will include 15 post-menopausal women who will be treated by acupuncture and anti-hypertensive drugs.
* Group (C): It will include 15 post-menopausal women who will be treated by DASH diet, acupuncture and anti-hypertensive drugs.

Eligibility Criteria:
Inclusion Criteria:

* Their body mass index will be ranged from 25 -29.9 kg/m2
* All patients will be medically stable when attending the study.
* The DASH eating plan of 1800 kcal per day will be used in the study.

Exclusion Criteria:

* Auditory and visual problems.
* Chronic renal failure.
* Myocardial infarction or arrythmias with heart failure.
Study of Roxadustat in the Treatment of Acute Myocardial Infarction

Depite successful primary percutaneous coronary intervention (PCI) and standardized medical treatment, prognosis of acute ST-elevation myocardial infarction patents are still a poor, with high morality and various complications such as heart failure. Roxadustat is a new drug targeting hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibition and has shown promising effect in reducing infarct size in pre-clinical studies.

This study aims to evaluate the efficacy and safety of early and short-term administration of roxadustat in the treatment of acute ST-elevation myocardial infarction.

This study is an open-label, paralleled, randomized controlled trial. It aims to evaluate the efficacy and safety of early and short-term administration of roxadustat in the treatment of acute ST-elevation myocardial infarction.

Eligibility Criteria:
Inclusion Criteria:

* Acute STEMI (ST segment elevation myocardial infarction) diagnosed by ST elevation
* Coronary angiography within 12 hours of symptom onset, with TIMI flow grade 0 - 1 of culprit vessel
* Primary PCI with TIMI flow grade 2 - 3 after successful intervention
* Capable and willing to provide informed consent and capable of completing study visits

Exclusion Criteria:

* Previous acute myocardial infarction history
* Cardiogenic Shock at admission
* Previously treated by roxadustat
* Contraindications of roxadustat treatment
* Contraindication of Cardiac MRI (e.g. eGFR \< 30 ml/min, pacemaker, metal prosthesis, etc.)
Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea

This study is being carried out to see if dapagliflozin and dapagliflozin plus saxagliptin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glimepiride (sulphonylurea) as an addition to metformin treatment.


Eligibility Criteria:
Inclusion Criteria: Main Inclusion Criteria:

1. Is male or female and ≥18 and \<75 years old at time of informed consent.
2. Has a HbA1c of ≥7.5% and ≤10.5% based on central laboratory results from Visit 1, with individual need for therapy escalation.
3. Currently treated with a stable maximum tolarated dose (MTD) (≥1500 mg/day) of metformin therapy for at least 8 weeks prior to Enrolment visit.
4. Has a BMI of ≤45 kg/m2 at Enrolment visit.
5. Has a C-peptide laboratory value of ≥1.0 ng/mL (0.33 nmol/L; 333.3 pmol/L) based on central laboratory results from Visit 1.

Main, Exclusion Criteria:

1. Clinically diagnosed with Type I diabetes, known diagnosis of maturity onset diabetes of the young (MODY), or secondary diabetes mellitus or known presence of glutamate decarboxylase 65 (GAD65) antibodies.
2. Patients who, in the judgment of the Investigator, may be at risk for dehydration or volume depletion that may affect the patient's safety and/or the interpretation of efficacy or safety data.
3. Clinically significant cardiovascular disease or procedure within 3 months prior to Enrolment or expected to require coronary revascularization procedure during the course of the study.
4. Concomitant treatment with loop diuretics
Coronary Flow and Myocardial Viability: the FloVITA Study

Evaluation of fractional flow reserve (FFR) is a key method for assessing ischemia with a view to guiding revascularization strategy following acute coronary syndrome. A stenosis that appears to be severe by angiography may cause limited ischemia (with an FFR value \>0.80) due to the incapacity of the necrotic zone to achieve physiological hyperemia, i.e. maximal coronary flow. Recently, it has been demonstrated that absolute coronary flow, and micro- and macrovascular resistance, as measured by a thermodilution technique, using the Rayflow microcatheter (Hexacath) are strongly associated with myocardial mass. In extensive necrosis, there is a loss of myocardial mass, and these tools could be of potential interest in measuring myocardial viability, which reflects the extent of remaining viable myocardial mass.

Therefore, this study aims to investigate the relationship between both absolute coronary flow and microvascular resistance, and myocardial viability assessed by MRI.

In a prospective, single-centre, interventional study, we will compare absolute coronary flow and microvascular resistance in the left anterior descending artery, in patients with and without a history of ST segment elevation MI.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for the STEMI group:

  * ST segment elevation MI ≥7 days treated by angioplasty of the left anterior descending (LAD) artery
  * Scheduled to undergo angiography for fractional flow reserve (FFR) assessment of a lesion other than the infarct-related artery.
* Inclusion criteria for the control group:

  * patients undergoing non-urgent coronary angiography for stable angina or silent ischemia
  * with measure of the FFR on one or more vessels (intermediate lesion \<90% without proven ischemia)
* absence of any significant lesion on the LAD (as assessed by angiography or FFR\>0.8)
* Inclusion criteria for both groups:

  * Written informed consent
  * Affiliation to a social security regimen (or beneficiary thereof).

Exclusion Criteria:

* Target vessel (LAD) not permeable.
* FFR \<0.8 in the LAD
* Coronary spasm
* Left ventricular ejection fraction \<0.50 or a history of anterior MI in patients in the control group
* Hypertrophic cardiomyopathy
* Severe valvular heart disease
* History of coronary artery bypass graft
* Patients with limited legal capacity or patients under guardianship/tutorship
* Patients with anticipated poor compliance as assessed by the investigator
* Patients not affiliated to any social security regime.
* Pregnant women.
* Subjects within the exclusion period of another clinical trial as noted in the national registry of research volunteers
Permanent Resin Restorations Fabricated by Three Dimension Printer

Additive manufacturing (AM) and 3D printing (3DP) technologies have advanced significantly in many different areas. With the time and cost advantage it provides in low-volume production, 3D printing technologies also come to the fore in the field of digital dentistry. A tooth-coloured, ceramic-filled permanent resin has been introduced by the manufacturer for the 3D fabrication of permanent single crowns, veneers, inlays and onlays. The aim of this clinical study was to clinically evaluate the long-term survival and intraoral performance of 3D-printed permanent resin. to the ICDAS caries classification system, 20 volunteers between the ages of 18-65 with class II caries lesion at D1 or D2 level were included in this study. Restorations were checked 1 week (baseline) and 6 months after completion and scored using the Modified Ryge Criteria (USPHS2(United States Public Health Service)). Statistical analysis was done by Kaplan-Meier survival analysis.

The design and manufacture of 3D printed restorations relies on the exchange of digital information (data) between 3D imaging, 3D virtual planning and/or 3D printing technologies. One of the key points in the widespread use of 3D printers is the emergence of these systems that allow data from different sources to be used in a personal computer with various design and production technologies. It saves Digital Imaging and Communication in Medicine (DICOM) files in STL format. STL files can be printed and processed with various CAD/CAM systems in local manufacturing or remote labs. This is an important advantage of using open source. With these systems, it is possible to produce restorations with clearer anatomical features thanks to current 3D printing technologies. In other words, low-cost restorations with more useful properties can be produced.

Eligibility Criteria:
Inclusion Criteria:

* premolar and/or molar tooth has class II caries lesion at D1 or D2 level according to ICDAS caries classification system.

Exclusion Criteria:

* bad oral hygiene
* bruxism,
* malocclusion,
* dry mouth,
* periodontal disease,
* teeth with restoration,
* periodontal or periapical pathology non-opposite and/or non-contact teeth will not be included in the study.