cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Nutritional Status in Thalassemia Major Patients in Assiut Children Hospital

Thalassemia is a blood disorder passed down through families in which the body makes an abnormal form of hemoglobin. There are 2 main types of thalassemia; Alpha \& Beta thalassemia. Alpha thalassemia: occurs when a gene or genes related to the alpha globin protein are missing or mutated.

Beta-thalassemia syndromes are a group of hereditary blood disorders characterized by reduced or absent beta globin chain synthesis. Beta-thalassemias can be classified into:

Silent carrier: completely asymptomatic with normal hematological parameters. Beta-thalassaemia minor (beta-thalassaemia trait): usually asymptomatic; diagnosis is made during a work-up for mild anemia.

Beta-thalassaemia intermedia: usually a similar presentation to beta-thalassaemia major; symptoms are usually less pronounced and the course is usually more insidious.

Beta-thalassaemia major : In which there is complete absence of hemoglobin A

In Egypt beta thalassemia-major is the most common type with carrier rate of 5.3 to ≥9%and 1000 new cases born with beta-thalassemia major per 1.5 million live births per year.

Children born with thalassemia major are normal at birth, but develop severe hemolytic anemia during the first year of life. Symptoms are those of anemia (lethargy, poor feeding, pallor...etc.) failure to thrive and organomegaly. Later on they develop signs of extra medullary hematopoiesis .

Optimal nutritional status is important for growth, immune function, bone health and pubertal development . Various reports suggest the incidence of poor growth ranges from 25% to 75% depending on thalassemia syndrome and severity of disease. This marked growth deficits raise a red ﬂag for any pediatrician to evaluate nutritional status of thalassemic patients and detect possible nutritional deficiencies and associated factors.

Etiology of delayed growth and malnutrition reported in thalassemic patient is multifactorial including :

1. Nutritional deprivation with or without feeding difficulties arising from fatigue and breathlessness
2. Increased energy expenditure secondary to hyper metabolism with or without heart failure
3. Gastrointestinal hypoxia which consequently produces anorexia and malabsorption
4. Reduction of biosynthetic activity of liver.
5. Disturbance of the endocrine function
6. Impaired synthetic hepatic function secondary to hemosiderosis and hepatitis.

The main aim of this study is to assess the nutritional status of thalassemic patient attending Assiut university Children hospital and to determine the factors involved.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed to have thalassemia

Exclusion Criteria:

* patient with any underlaying systemic diseases other than B thalassemia major.
Predictive Models for Intensive Care Admission and Death of COVID-19

To build simple and reliable predictive scores for intensive care admissions and deaths in COVID19 patients. These scores adhere to the TRIPOD (transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) reporting guidelines.

The outcomes of the study are (i) admission in the Intensive Care Unit admission and (ii) death.

All patients admitted in the Emergency Department with a positive reverse transcription-polymerase chain reaction SARS-COV2 test were included in the study. Routine clinical and laboratory data were collected at their admission and during their stay. Chest X-Rays and CT-Scans were performed and analyzed by a senior radiologist.

Generalized Linear Models using a binomial distribution with a logit link function (R software version X) were used to develop predictive scores for (i) admission to ICU among emergency ward patients; (ii) death among ICU patients. A first panel of Number Models with the highest AIC (BIC) was preselected. Ten-fold cross-validation was then used to estimate the out-of-sample prediction error among these preselected models. The one with the smallest prediction error was in the end singled out .


Eligibility Criteria:
Inclusion Criteria:

* RT-PCR + SARS Cov2 pneumonia

Exclusion Criteria:

* \< 18 ans -\* GOLD 3 or 4 CPOD
Veno-venous Extracorporeal CO2 Removal in ARDS-patients to Treat Respiratory Acidosis

Hypothesis:

Extracorporeal removal of CO2 can treat hypercapnia and respiratory acidosis, which allows application of lung protective ventilation. This downgrading of mechanical ventilation promotes better and more quickly lung recovery.

Aim:

The aim of the study is to treat respiratory acidosis and to reduce plateau pressures by using an extracorporeal removal of CO2 (ECCO2-R).

This prospective study will include 10 patients with an Acute Respiratory Distress Syndrome (ARDS). ARDS is an inflammatory response in the lungs, the onset is acute with pulmonary oedema and shows bilateral densities on chest radiography. The take up of oxygen and the loss of CO2 in the lungs are difficult. Moreover the patient's blood can become acidic due to too much CO2.

To promote a better gas-exchange, the patient with ARDS will be mechanically ventilated. This can be aggressive and harmful for the lungs. With the use of an extra-corporeal CO2-remover, CO2 can be removed so that the mechanical ventilation setting will be less aggressive and will decrease lesions in the lung. The veno-venous extracorporeal CO2-remover pumps blood from a vein via a catheter through an oxygenator (gas exchanger that adds oxygen to the blood and extracts carbon dioxide from the blood) and back into a vein.

The investigators will use a standard dialysis catheter that will be put in a large vein. To prevent clotting of the system, the patient will receive heparin.

In the study the investigators will work in periods of two hours, the situation before and after carbon dioxide removal will be compared. With this study the investigators want to prove that the CO2 in the blood decreases with at least 20 % with the use of the extracorporeal CO2 remover. More over the investigators want to prove that lower mechanical ventilation settings (thanks to CO2-removal by the ECCO2-R) will produce fewer lesions to the lungs.


Eligibility Criteria:
Inclusion criteria:

* Acute onset of ARDS criteria on chest X-ray or CT scan
* Moderate (PaO2/ FiO2 \<200) or severe ARDS (PaO2/ FiO2 \<100) (FiO2: fraction of inspired oxygen)
* Respiratory acidosis with pH\< 7,25,
* With plateau pressure of 28cmH20 or higher,

Exclusion criteria:

* \<18 years of age
* Pregnancy
* Obesity with BMI\> 30
* Contraindication for anticlotting therapy
* Chest wall abnormalities
* No presumed consent of representatives
Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder

The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)
* At least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode.
* Able to understand and comply with the requirements of the study.

Exclusion Criteria:

* Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year.
* Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator.
* Previously randomized into this study or D1447C00126
Pre-Screening Study to Identify MTAP Loss in Advanced Solid Tumors or Lymphoma

The purpose of this study is to identify subjects with advanced solid tumors or lymphoma in which the methylthioadenosine phosphorylase (MTAP) protein has been lost.

Study AG270-PS-001 is a pre-screening study to identify subjects with advanced solid tumors or lymphoma in which the MTAP protein has been lost. Subjects whose tumor tissue has lost the MTAP protein may be considered for future enrollment into a Phase 1 clinical study of an experimental drug, AG-270, that is designed to inhibit the growth of tumors lacking this protein.

Identification of the loss of MTAP will rely solely on the evaluation of archival tumor tissue samples by IHC. This study is therefore non-interventional

Eligibility Criteria:
Inclusion Criteria:

1. Be ≥18 years of age.
2. Have a histologically confirmed diagnosis of an advanced solid tumor (other than a primary CNS malignancy) or lymphoma.
3. Have archival tumor tissue that can be provided for assessment of MTAP deletion status.
4. Have given written informed consent to participate in this study.

Exclusion Criteria:

1. Have a primary CNS malignancy (eg, GBM).
2. Have a medical or psychological condition deemed by the Investigator likely to interfere with the subject's ability to give informed consent or participate in the study.
Neuroprotection and Repair in Optic Neuritis

The primary aim of this open-label pilot trial is to estimate the treatment effect of 100 mg of oral minocycline twice daily for 90 days, initiated within 30 days of onset of ON, on functional and structural optic nerve recovery compared to no treatment. The primary outcome measure that will be used to measure optic nerve recovery is retinal nerve fibre layer (RNFL) thickness. Other objectives: Secondary outcomes are temporal RNFL thickness, macular volume, and visual outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years, the lower age limit has been set for safety purposes to avoid exposing children and adolescents to unproven therapies at least early in their development, the upper limit is set because the specificity of the diagnosis of ON is likely reduced in older individuals
* onset of ON within the previous 30 days
* intention to continue current multiple sclerosis (MS) disease modifying therapy (if any) for at least 6 months (glatiramer acetate, interferon beta) and not start, or switch to, a new therapy
* sexually active participants of child-bearing potential must agree to use adequate contraception
* willingness to provide written informed consent

Exclusion Criteria:

* Coexistence of any disease other than MS that could be responsible for ON or better explains their signs and symptoms. This would include patients with other suspected or established causes of vision loss including glaucoma, maculopathies, amblyopia, neuro-myelitis optica (NMO), and other optic neuropathies
* clinically significant liver, renal, or bone marrow dysfunction
* any condition that could interfere with any evaluation in the study including patients who are unable to undergo reliable OCT testing due to dense media opacities or severe nystagmus in whom appropriate fixation cannot be attained
* concurrent or prior use of corticosteroids during this episode of optic neuritis
* concurrent participation in any clinical therapeutic trial
* use within the previous 12 months of any of the following: natalizumab, mitoxantrone, cyclophosphamide, azathioprine, cyclosporine, methotrexate, or any other immunomodulating or immunosuppressive drug including other recombinant or non-recombinant cytokine or any experimental therapy known to effect immune function
* use within the previous 6 months of minocycline or another tetracycline or use of either for MS at any time
* any other condition or situation that in the opinion of the investigator would either put the patient at risk of worsening health if enrolled in the trial or would prevent completion of the trial with complete follow-up.
Functional and Anatomical MRI of the Spinal Cord and Peri-spinal Tissues

The current study is an amendment to a previously approved blinded randomized controlled trial (NCT02697812) which examines the rate at which the sternal retraction maneuver is performed during cardiac surgery (standard over 30 seconds versus. gradual over 15 minutes) and examines the incidence of chronic post-sternotomy pain 6 months following surgery.

Patients enrolled in the parent study will be identified at the 6 month follow-up and recruited in terms of whether they report chest pain. A total of 30 participants will be recruited (15 with and 15 with no pain) to undergo a single MRI session in which functional MRI will be done on the brain stem and spinal cord and anatomical MRI images will be collected for specific chest and neck structures. This will indicate whether there are long-term differences in pain processing and/or physical damage to neck and chest structures in those with and without chronic pain 6 months following coronary artery bypass graft surgery. All functional and anatomical MRI images will be reviewed and interpreted with study personnel blinded to whether the patient is reporting pain or no pain at their 6 month follow-up interview.


Eligibility Criteria:
Inclusion Criteria:

* Elective Primary Coronary Artery Bypass Surgery
* Understanding and provision of written informed consent
* Age \> 18 and \< 75
* ASA class I, II or II

Exclusion Criteria:

Any combined or redo cardiac procedure

* Current alcohol or substance abuse
* Pre-existing chronic pain requiring chronic analgesic use
* Rest pain in proposed surgical area at baseline, preoperatively
* Chronic Steroid use
* Inability to perform post-operative assessments
Making SPARX Fly in Nunavut: Pilot Testing an E-intervention for Boosting Resilience Against Youth Depression

The goal of this pilot trial was to test SPARX with Inuit youth in Northern Canada. SPARX is an educational video game designed to teach cognitive behavioural therapy strategies and techniques. This "serious game" has previously shown promise in addressing symptoms of depression with Māori youth in New Zealand. Researchers in this study tested SPARX's suitability with Inuit youth in the territory of Nunavut using surveys that youth completed before and after gameplay.

Hypothesis 1: Youth who completed SPARX were expected to experience a decrease in depressive symptoms and risk factors related to depression. Hypothesis 2: Youth who completed the SPARX program were expected to experience an increase in factors related to resilience.

A team of Nunavut-based community mental health staff facilitated youth's participation in this remote pilot trial with 24 youth aged 13-18 across 11 communities in Nunavut. These youth had been identified by community facilitators as showing low mood, depression, and/or significant levels of stress.


Eligibility Criteria:
Inclusion Criteria:

* one or more of the following:

  * low mood
  * negative affect
  * depressive presentations
  * significant levels of stress and:
  * sufficient English language comprehension to use and understand SPARX

Exclusion Criteria:

None
Inflammatory Markers and Cognitive Function in Major Depression

Major depression is accompanied by cognitive changes as well as alterations in multiple physical functions. The inflammatory system is altered generally toward a pro-inflammatory state. Antidepressants are associated with a decrease in this proinflammatory state. This study aims to generate pilot data concerning a possible link between cognition, inflammation and response to treatment. The cognitive function of subjects with major depression will be tested before and after treatment with duloxetine. Inflammatory markers will be measured at both time points.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-50 Primary diagnosis of major depression Ability to give informed consent

Exclusion Criteria:

* Neurologic disorders affecting cognition
* Unstable or untreated medical disorders
* Medical disorders associated with pain
* Recent pregnancy or delivery
* Psychiatric disorders other than MD which are the primary focus of treatment
* Treatment with antidepressants in the past 4 weeks
Think FAST Research Study

To test a 14-hour prolonged nightly fasting (PNF) protocol in a group of older adults (≥ 65 years old) with self-identified age-related cognitive decline (ARCD) on the primary outcome of neurocognitive function and performance as measured by objective outcomes. The investigators will use an 8-week single group pre-post pilot study design to measure outcomes related to neurocognitive function and performance and cardiometabolic risk factors (i.e., sleep disturbances, body mass index).


Eligibility Criteria:
Inclusion Criteria:

* 65 or older
* Self-identified age-related cognitive decline (ARCD)
* Has a text capable phone and access to wifi

Exclusion Criteria:

* Diagnosed with an eating disorder in the past 20 years
* Works a night shift
* Cannot participate in a 14 hour fast
* Has diabetes
Laparoscopy-assisted and Open Distal Gastrectomy for Gastric Cancer in the Elderly Patients

* Laparoscopy-assisted distal gastrectomy for the treatment of early gastric cancer (EGC) has been supported by high-quality evidence, and the high-level evidence for advanced gastric cancer based on large prospective randomized controlled trial as CLASS-01、JCOG 0901, KLASS -02 is still awaited.Hopefully, it would have also gained the solid evidence of laparoscopy-assisted distal gastrectomy for the treatment of advanced gastric cancer (AGC).
* China has entered the aging society since 1999. Among the GC patients in China, the average age is 65 years old, which makes increasing attempts to explore laparoscopic techniques in the treatment of elderly patients.
* Nowadays, a considerable proportion of elderly patients suffer from multiple diseases, such as hypertension, diabetes, coronary heart disease. Thus the risk of intraoperative and postoperative complications can not be ignored. Unfortunately, there are rare studies specializing into the LAG for the GC patients of \> 65 years old.
* Accordingly, the comparison of intraoperative and postoperative complications between laparoscopy-assisted and open distal gastrectomy for over 65 years old patients with gastric cancer based on a randomized controlled trial is warranted.


Eligibility Criteria:
Inclusion Criteria:

* Age over 65 years
* Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
* cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
* Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
* Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
* ASA (American Society of Anesthesiology) score class I, II, or III
* Written informed consent

Exclusion Criteria:

* Severe mental disorder
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
* Exclude the early gastric cancer feasible for ESD
* Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
* History of other malignant disease within past five years
* History of previous neoadjuvant chemotherapy or radiotherapy
* History of unstable angina or myocardial infarction within past six months
* History of cerebrovascular accident within past six months
* History of continuous systematic administration of corticosteroids within one month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* FEV1\<50% of predicted values
First-in-Human Study of TSHA-101 Gene Therapy for Treatment of Infantile Onset GM2 Gangliosidosis

GM2 gangliosidoses are a group of autosomal recessive neurodegenerative diseases characterized by a deficiency of the Hex A enzyme to catabolize GM2, thereby causing GM2 accumulation within cellular lysosomes.Hex A is composed of 2 subunits, α- and β-, coded by the HEXA and HEXB genes, respectively. The primary purpose of the current study is to assess the safety and tolerability of TSHA101 administered via IT injection.


Eligibility Criteria:
Key Inclusion Criteria:

* male or female with age less than or equal to 15 months
* diagnosis of GM2 gangliosidosis with genetic and enzymatic documentation of infantile disease

Key Exclusion Criteria:

* a second neurodevelopmental disorder independent of the HEXA or HEXB
* inability to tolerate sedation or intrathecal administration
* invasive ventilatory support
* concomitant illness, allergies or known hypersensitivity to the required immunosuppression regimen
Treatment of CFS & Fibromyalgia With Recovery Factors

The study will explore if Recovery Factors improve symptoms in fibromyalgia and chronic fatigue syndrome

Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. The treatment is a unique nutritional peptide mix derived from porcine serum

Eligibility Criteria:
Inclusion Criteria:

* Meet ACR 2010 amended Fibromyalgia criteria or CDC CFS Criteria Overall well being score of 5 of less (on 0-10 VAS)

Exclusion Criteria:

Pregnant Clotting disorders

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Immune Checkpoint Inhibitors and Radiotherapy in Relapsed/Refractory Hodgkin Lymphoma

This is an observational retrospective study to investigate the efficacy and safety of the treatment with an immune checkpoint inhibitor (nivolumab or pembrolizumab) in combination with radiotherapy in patients with relapsed/refractory classical Hodgkin lymphoma.

In patients with relapsed/refractory Hodgkin lymphoma, treatment with immune checkpoint inhibitors (ICIs), nivolumab and pembrolizumab, leads to 20-30% of complete remission (CR) rate. This means that for the majority of patients a consolidation strategy is usually offered, in order to reduce relapse rate.

Strategies to improve CR rates should therefore be implemented, including combination treatments. In solid tumors, the combination of ICIs and radiotherapy led to higher response rates without mjor toxicity concerns. Radiotherapy is an effective therapeutic option already used in Hodgkin lymphoma patients, also in the setting of relapsed/refractory disease. In his observational study we aim to evaluate the efficacy and safety of ICIs and radiotherapy administered in combination in patients with relapsed/refractory Hodgkin lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* diagnosis of classical Hodgkin lymphoma, treated with one immune checkpoint inhibitor (ICI) (nivolumab or pembrolizumab), as per label indication
* having received a concomitant radiotherapy, as per clinical need (persistence of localized disease, bulky disease, other reasons). "Concomitant" radiotherapy means a treatment received during the administration of ICI, or during the 8 weeks that precede or follow the start or the end of the treatment with ICI

Exclusion Criteria:

* Having received a treatment with an ICI and radiotherapy not "concomitant", according to the abovementioned definition
* Having received any other anti-lymphoma treatments during the same period of time
* Patients who have not been evaluated by CT-PET or CT at the end of the combination therapy