cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Intrathecal Rituximab in 16 Children of Stage Ⅲ、ⅣNon-Hodgkin Lymphoma

Objective: This study demonstrated that the efficacy and safety of intrathecal(IT) rituximab in the treatment of stage Ⅲ and Ⅳ non-Hodgkin lymphoma(NHL) in children.

Methods: We reported 16 children were histologically diagnosed as stage Ⅲ and Ⅳ NHL from September 2015 to December 2020 who received IT rituximab in Pediatric Oncology of Sun Yat-Sen Memorial Hospital were restrospectively analyzed. The clinical manifestations, central nervous system involvement,treatment plan and prognosis of patients were analyzed....

ALL patients were pathologically positive for CD20 received the modified NHL-BFM 95, while IT rituximab was arranged the day before the chemotherapy, which was simultaneously used with the intravenous infusion of rituximab. The median time of doses received by each patient was 5 times, every three weeks, with the IT dose of 10 mg,15 mg, and 20 mg in increments.

Malignant lymphoma is one of the most common malignancies in children, with approximately 60 percent of cases being B-cell, non-hodgkin lymphoma (NHL) . NHL in children progresses rapidly, prone to bone marrow and central nervous system (CNS) involvement , CNS-infested NHL has a poor prognosis regardless of primary or secondary , high-intensity chemotherapy, intravenous rituximab (RTX), radiotherapy, and hematopoietic stem cell transplantation, HSCT) has limited efficacy in the treatment of these children because only a small percentage of drugs/antibodies can penetrate the blood-brain barrier . Only a limited number of intrathecal agents, primarily methotrexate, steroids, and cytarabine, have been identified that have demonstrated safety in the use of CNS-violated NHL but have not improved long-term survival in these children . Therefore, whether safe and effective intrathecal drugs can be found is the focus of the treatment and prevention of CNS-infused NHL.

Most B-cell NHL tumors express CD20 antigen in tumor tissues , RTX is a chimeric monoclonal antibody specific to B-cell CD20 antigen, and a large number of studies have confirmed that intravenous infusion of RTX has a good effect on adult and pediatric B-cell NHL . However, intravenous RTX concentrations in cerebrospinal fluid are low, ranging from 0.1 to 4.4 percent of the blood concentration, and repeated intravenous use does not increase its drug concentration in the cerebrospinal fluid . Recent small clinical studies have shown that intrathecal RTX injection is safe in adult lymphoma patients , but there are no domestic cases of intrathecal RTX use in childhood lymphoma. In this paper, 16 clinical cases of intrathecal RTX injection of stage III and IV. B-cell NHL were analyzed to explore the safety and efficacy of RTX intrathecal therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of B lymphocyte NHL
2. Age≤ 18 years old
3. Normal heart and kidney function

Exclusion Criteria:

1. Heart, liver and kidney diseases
2. Allergic to rituximab
Effect of Stellate Ganglion Block on New Atrial Fibrillation After Coronary Artery Bypass Grafting

Post-operative new-onset atrial fibrillation (POAF) is one of the most common arrhythmias in adults after direct intracardiac surgery with extracorporeal circulation. The incidence of POAF in coronary artery bypass grafting (CABG) is approximately 30%. POAF can lead to an increased risk of complications such as stroke, heart failure, and acute kidney injury, which not only prolongs the patient's hospital stay, but also increases hospital costs and mortality. operation, extracorporeal circulation, and the patient's underlying conditions (such as age, gender, hypertension, and diabetes), which cause sympathetic activation, inflammatory response, and myocardial ischemia in the organism. The stellate ganglion block (SGB) regulates the sympathetic tone of the innervated nerves and thus the autonomic function of the body. SGB can effectively regulate the sympathetic-parasympathetic imbalance. Also, SGB may exert some anti-inflammatory effects. In this study, ultrasound-guided SGB was used in CABG patients to investigate its effect on the occurrence of POAF.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing first-time and elective coronary artery bypass grafting;
* ASA grade II-IV；
* The preoperative ECG showed sinus heart rate.

Exclusion Criteria:

* The patient refused to participate in this study;
* Surgical procedures include any other type of heart surgery in addition to CABG；
* Allergic to known general anesthesia drugs;
* Patients with a history of neck surgery or abnormal neck anatomy;
* Patients with contraindications to SGB.
Selinexor Treatment of Refractory Myeloma

This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).

This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd), both dosed twice weekly in each four-week cycle, in patients with MM previously treated with lenalidomide, pomalidomide, bortezomib, carfilzomib, and daratumumab and refractory to prior treatment with glucocorticoids, an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and daratumumab.

This study consists of two parts:

* Part 1 enrolled patients with both quad-refractory MM and penta-refractory MM.
* Part 2 will enroll patients with penta-refractory MM only.

Eligibility Criteria:
Inclusion Criteria:

Measurable MM based on modified IMWG guidelines. Defined by at least one of the following:

1. Serum M-protein ≥ 0.5 g/dL by serum electrophoresis (SPEP) or for IgA myeloma, by quantitative IgA
2. Urinary M-protein excretion ≥ 200 mg/24 hours
3. Free Light Chain (FLC) ≥ 100 mg/L, provided that the FLC ratio is abnormal
4. If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative Ig levels by nephelometry or turbidimetry are acceptable

   * Must have previously received ≥ 3 anti-MM regimens including: an alkylating agent, lenalidomide, pomalidomide, bortezomib, carfilzomib, daratumumab, and a glucocorticoid. There is no upper limit on the number of prior therapies provided that all other inclusion/exclusion criteria are met.
   * MM refractory to previous treatment with one or more glucocorticoids, parenteral PI (i.e., bortezomib and/or carfilzomib), IMiD (i.e., lenalidomide and/or pomalidomide), and the anti-CD38 mAb, daratumumab. Refractory is defined as ≤ 25% response to therapy, or progression during therapy or progression within 60 days after completion of therapy.

Exclusion Criteria:

* Active smoldering MM.
* Active plasma cell leukemia.
* Documented systemic amyloid light chain amyloidosis.
* Active CNS MM.
Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia

The purpose of this randomized study is to clarify if neoadjuvant radiochemotherapy gives a higher degree of complete histological response than neoadjuvant chemotherapy before surgery in patients undergoing treatment for cancer of the esophagus or cardia.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified squamos cell carcinoma, adenocarcinoma of the esopohagus or gastric cardia (type II)
* Tumor located in cervical oesophagus, not requiring laryngo-esophagectomy. Patients with performance status 0-1 axxording to WHO scale and with resectable tumours, as assessed at the prerandomisation evaluation
* Adequate haemotological function, defined as having WBC \> 3 x 10(9)/litre and platelets \> 100 x 10 (9)/litre.
* Adequate renal function defined as having normal serum creatinine level and/or calculated glomerular filtration rate \> 60 ml/min.
* Tumour stage: T1Ni, T2N0, T2N1, T3N0, T3N1, M1a

Exclusion Criteria:

* Pregnancy and/or lactation. Women of childbearing ages can be included and provided that adequate contraceptive methods are used
* Patients with diabetes complications (e.g. rethinopathy, neuropathy) as well as patients with uncontrolled cardiac disease or myocard infarction within 12 months are considered unsuitable for chemoradiotherapy.
* Concomitant malignancy (\< 5 years since diagnosis) that can interfere the interpretation of study results, ongoing antitumoral treatment.
* Patients being unable tom comply with the protocol
* Tumor stage T1 N0, T4 NX or TXNXM1b
Fundamental Movement Skills, Body Mass Index and Quality of Life in Children

Early childhood obesity is a serious worldwide problem, and fundamental movement skills (FMS) are very important factors in human movement. Thus, several advanced studies have examined the associations between FMS, body mass index (BMI) and quality of life.

The purpose of this study was to investigate the relation between FMS, BMI and quality of life in Egyptian school aged children.

A total of 216 primary school aged children, aged 5-7 y from both sex participated in this study. FMS were measured using the Test of Gross Motor Development-II (TGMD-II), and BMI was calculated as the weight (kg) divided by the square of the height (m) \[weight/ height2\] ,and quality of life was measured by PedsQol scale

Eligibility Criteria:
Inclusion Criteria:

- normal school aged children , aged 5-7 years with different weight categories

Exclusion Criteria:

* children with visual or auditory problems or those who experienced surgery in their lower limbs 1 year before study
Prevalence of Pain in Inpatient at the Hospital Italiano de Buenos Aires

The purpose of this study is to determine the prevalence of patients with acute and chronic pain in the area of inpatient at the Hospital Italiano de Buenos Aires.

The diagnosis and treatment of pain during hospitalization are becoming increasingly important. In recent decades there have been articles that explain that pain is underdiagnosed, that there are patients who do not receive treatment or that it fails to decrease pain intensity. It has now been shown that pain is a common problem during hospitalization, showing a prevalence of 38 to 91% depending on the population studied.

Published studies show that there are three types of pain during hospitalization: acute or chronic pain that motivates the admission and continues during hospitalization, pain that appears during hospitalization but was not the cause of the admission or associated with health care, and,pain that appears during the hospitalization associated with health care. To complete the description of patients with pain during hospitalization it has been suggested the existence of a fourth group of patients presenting with chronic pain that does not motivate the admission but persists and does not interfere during hospitalization. In a study evaluating the Italian population shows that the prevalence of pain is modified by marital status and age, and the intensity of pain increases with time evolution of pain and days of hospital stay. Some studies, mainly in Europe, show that the use of analgesics is high but the adherence to guideline recommendations for treatment of pain is low, or that the presence of pain is not recorded in the medical chart compared to the indication of analgesic treatment.

These results demonstrate the need to determine the prevalence of pain in hospitalization at each institution, distinguishing the case of pain prior to admission or appearing during the same (or motivation), evaluating the indication of pain at each hospital, in order to learn about the current situation and design and implement actions to improve pain management in this institution.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18 years.
* Evaluated at 48 hours after hospital admission in areas general hospitalization, coronary care unit, adult intensive care, intermediate care and day hospital of the Hospital Italiano Central

Exclusion Criteria:

* Refusal to participate in the study or the informed consent process.
* Inability to understand or express pain (aphasia, dementia).
* Alteration ef the sensory.
* Language other than Spanish.
* Inpatient at the emergency room.
* Presence of acute confusion or delirium.
Fermented Food-Supplemented Diet in Ulcerative Colitis

The purpose of this study is to see how a diet that supplements fermented foods effects inflammation and quality of life in patients with mild to moderate Ulcerative Colitis (UC). There is a paucity of research and an enormous need for better understanding of diet and intestinal inflammation. Fermented food have been shown to positively influence inflammatory cytokines and intestinal microbial diversity in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Male or female subjects, ≥18 years of age
* Confirmed diagnosis of UC
* Symptomatic disease defined as partial Mayo Score 2 to 7 (inclusive)
* Elevated fecal calprotectin

Exclusion Criteria:

* Women who are pregnant, nursing or expect to be pregnant
* Intolerance to fermented food
* Individuals with a body mass index (BMI) lower than 18
* Individuals diagnosed with a serious medical condition (unless approved in writing by a physician)
* Individuals who have been severely weakened by a disease or medical procedure
* Individuals with more than mild-moderate cardiovascular disease or life-threatening cancer (as determined by patient's physician) unless approved by a physician
* Individuals with history of severe cardiac disease (particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF \< 40%)
* History of relevant intestinal surgery such as total or hemi-colectomy, proctocolectomy, stoma.

Complications of disease such as extraintestinal manifestations (EIMs) are not automatically considered exclusion criteria. Appropriate medical treatment for UC and/or EIMs will not be withheld.
Neuropathic Pain in Psoriatic Arthritis

Pathogenesis of inflammatory diseases is suitable for eliciting neuropathic pain. The aim of this study is to evaluate the frequency of NP among PsA patients and relationship between disease activity, quality of life, functionality, and other numerous factors.

Neuropathic pain (NP) is the pain arising from a primary lesion or a dysfunction of nervous system. NP can affect central or peripheral nervous system and can be caused by numerous factors such as inflammation or neuroplastic changes. Inflammation can sensitize nociceptors in sensory nerves by promoting prostaglandin E2 and I2 secretion thus, cause neuropathic pain. Besides, a mixed pain pattern with neuropathic components is thought to be developed in chronic pain conditions. In this point of view, pathogenesis of inflammatory diseases is suitable for eliciting NP. In arthritic joints, even non-arthritic tissues are affected by the disease and a condition called peripheral sensitization develops. Previous studies about NP and inflammatory diseases link have focused on rheumatoid arthritis and number of studies about NP and psoriatic arthritis (PsA) is limited. In this manner the aim of this study is to evaluate the frequency of NP among PsA patients and relationship between disease activity, quality of life, functionality, and other numerous factors.

Eligibility Criteria:
Inclusion Criteria:

* being aged≥18
* being diagnosed PSA according to CASPAR criteria

Exclusion Criteria:

* additional conditions that could cause neuropathic pain (e.g. radiculopathy, polyneuropathy, depression, fibromyalgia)
* history of fracture or surgery
* endocrinopathies that could cause neuropathic pain (e.g. DM)
* malignancy
Fibromyalgia Treatment With Enzyme DAO

Fibromyalgia is a complex and common chronic pain disorder that affects 12 million Europeans. Fibromyalgia causes persistent widespread pain in muscles, tendons, ligaments, and joints, as well as widespread tenderness to touch and the presence of extreme fatigue and weakness.

Histamine is a molecule derived from an essential amino acid, histidine. It is stored in mast cells and basophils and is excreted through the intestine, being degraded as it passes through the intestinal mucosa by the enzyme Diamine Oxidase (DAO), which is found in this area. If there is any alteration in its metabolism and normal concentrations of histamine in the blood (50-70 mg/l) are not maintained, the free circulation of this amine in high concentrations triggers undesired effects, such as migraine, fibromyalgia, asthenia and atopy.

DAO deficiency is an alteration in the metabolism of dietary histamine that occurs when there is little activity of the DAO enzyme. The low activity of the enzyme causes that a concentration considered normal of histamine from food cannot be metabolized and a transepithelial penetration of exogenous histamine occurs. In this way, histamine passes into the bloodstream, increasing its plasma concentration and once located freely in the blood, it is distributed throughout different parts of the body, producing adverse effects.

One of the factors that causes DAO deficiency is genetics. The genetic sequence of DAO is found in a fragment located on chromosome 7 (7q34-q36) of the human genome. There are 85 single nucleotide variants (SNPs) located and identified in the human DAO gene (AOC1). Seven of these SNPs produce amino acid substitution, being candidates to cause alterations in the metabolic capacity of the enzyme.

Since histamine accumulation can trigger fibromyalgia, and the enzyme DAO has been shown to degrade histamine, oral supplementation with DAO food supplements, prepared from pig kidney, is suggested as a treatment for fibromyalgia.

The objective of this study is to analyze whether DAO enzyme supplementation reduces the characteristic symptoms of fibromyalgia. In addition, the prevalence of DAO deficiency in women with fibromyalgia will be identified by genetic analysis of DAO deficiency from a saliva sample. It will also be evaluated if patients require a lower intake of analgesics after supplementation with the enzyme DAO.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age between 30 and 59 years (included)
* Diagnosis of fibromyalgia
* Must sign an informed consent
* Able to follow-up at 2 and 6 months

Exclusion Criteria:

* Pregnant or possibly pregnant
* Patients with change of pharmacological treatment in the last 3 months
* Patients with DAO enzyme treatment
* Patients diagnosed with other severe diseases (i.e. cancer, cardiovascular disease, autoimmune disease or metabolic disease)
* Patients with multiple chemical sensitivity
Home-Administered Trial of Direct Current Stimulation

Transcranial Direct Current Stimulation (tDCS) is a novel non-invasive brain stimulation treatment that is effective with no significant side effects. It can potentially be self-administered by patients in their own homes with remote monitoring, substantially reducing treatment costs and increasing accessibility, including to remote areas. This study will evaluate the feasibility and efficacy of home-administered tDCS treatment for depression.


Eligibility Criteria:
Inclusion Criteria:

* Subject meets criteria for a DSM-IV Major Depressive Episode, lasting more than 4 weeks
* Total MADRS score ≥ 20

Exclusion Criteria:

* Diagnosis of any DSM-IV psychotic disorder
* History of drug or alcohol abuse or dependence in the preceding 3 months
* High suicide risk
* Clinically defined neurological disorder or insult
* Metal in the cranium or skull defects
* Skin lesions on the scalp (e.g. cuts, abrasions, rashes) at the proposed electrode sites
* Pregnancy
Observation of Rotation of an Intraocular Lens

The purpose of this study is to assess the axial IOL rotation after surgery with an MC 6125 AS IOL.

At the end of surgery the orientation of the IOL is documented with a short video clip via the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6 months after surgery. Rotational stability of the IOL is assessed using retroillumination images with a method to avoid bias from cyclorotation or head tilt.


Eligibility Criteria:
Inclusion Criteria:

* Uni or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation

Exclusion Criteria:

* Preceding ocular surgery or trauma
* Recurrent intraocular inflammation of unknown etiology
* Uncontrolled glaucoma
* Uncontrolled systemic or ocular disease
* Blind fellow eye
* Microphthalmus
* Corneal abnormality
* History of uveitis/iritis
* Iris neovascularization
* Pseudoexfoliation
* Proliferative diabetic retinopathy
Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir -Boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)- Naive Adults or Adults Recommencing ART.

This is a research study into the effects of three drugs used to treat HIV infection. Some drugs used to treat HIV have been associated with changes in blood fats such as cholesterol that could be harmful over the long-term, because these blood fat changes have been associated with a small, increased risk of heart disease and stroke in some studies of adults with HIV. Now that HIV can be controlled for long periods in most patients, and because heart disease is one of the biggest causes of illness and death in the general population, it is important to develop new HIV treatments that control HIV effectively but do not cause abnormal blood fats.

Hypothesis: That Raltegravir will result in less post-prandial lipid disturbances than ritonavir-boosted darunavir.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, informed consent
* Age \>18 years
* HIV infection documented by HIV antibody test and Western Blot prior to study entry
* No previous ART OR no ART for 6 months prior to randomisation
* CD4+ count of \<500 cells/mm or viral load \>10,000 copies/ml within 60 days prior to randomisation
* No genotypic resistance to Raltegravir, Tenofovir/emtricitabine, Darunavir, Ritonavir
* Body mass index less than 30kg/m2

Exclusion Criteria:

* Primary HIV infection within the last 6 months
* Active infection or opportunistic illness within the previous 30 days
* Use of any medication contra-indicated with ritonavir-boosted darunavir or raltegravir
* Use of lipid-lowering therapy
* Diabetes mellitus (fasting glucose \>7.0mml/l or a prior diagnosis of diabetes)
* Use of oral prednisolone \> 7.5mg daily or equivalent
* pregnancy or Breast feeding
* proven hypersensitivity to one or more components of the study meal