cyrilzakka/clinical-trials huggingface dataset:
Survival Outcomes of Multiple Myeloma Patients Admitted on Assiut Clinical Hematology Unit

Our study will discuss survival outcomes of multiple myeloma patients admitted on Assiut clinical Hematology and role of neutrophil to lymphocyte and lymphocyte to monocyte ratios as prognostic factors in multiple myeloma.

What are survival outcomes and the prognostic value of neutrophil to lymphocyte ratio of multiple myeloma patients admitted on Assiut clinical Hematology unit? Multiple myeloma (MM)is a plasma cell neoplasm associated with its characteristic clinical complications: anemia, infections, renal impairment or bone destruction. MM is the second most commonly diagnosed hematological neoplasm, with an incidence rate of 6.2 per 100 000 individuals .

Survival outcomes have remained constant over the past few decades; therefore, MM is still considered incurable. However, the increasing use of autologous stem cell transplantation (SCT) and the introduction of novel therapeutic agents, such as thalidomide and bortezomib, have improved the survival of myeloma patients .

Relationship between inflammation and cancer have been established. Some inflammatory factors from accessory cells in tumor milieu, such as interleukin-1 (IL-1), IL-6, and tumor necrosis factor-alpha (TNF-α), facilitated cancer cells' invasiveness .

Further studies exhibited the reactive oxygen and nitrogen from inflammatory cells induced mutation of some tumor suppressor genes, and inflammatory factors such as IL-6 and prostaglandin E2 (PGE2) caused DNA methylation, which both played an important role in tumorigenesis. Accordingly, neutrophil to lymphocyte ratio (NLR) coinciding with rationales supported by numerous studies, could offer a precise potency in predicting prognosis of cancers. In fact, many studies already demonstrated the prognostic significance of NLR in various cancers Consistently, a number of meta-analyses further confirmed this view in colorectal cancer, lung cancer, ovarian cancer, breast cancer, and lymphoma and others.

Eligibility Criteria:
Inclusion Criteria: clinical and laboratory diagnosis of multiple myeloma

* multiple myeloma patients received chemotherapy in our unit.

Exclusion Criteria:

* Waldenstrom macroglobulinemia
* MGUS
* Amyloidosis
* Other plasna cell disorders
A Cross Sectional Study Evaluating the Mean Levels of Alpha Fetoprotein in Patients of Hepatocellular Carcinoma and Its Correlates in Pakistan

This study aims to explore the levels of alpha-fetoprotein (AFP), a protein often elevated in liver cancer, in patients with hepatocellular carcinoma (HCC). The goal is to determine whether AFP levels vary based on the size of the liver tumor or other health conditions like hepatitis B, hepatitis C, and obesity. By analyzing data from 94 patients, the study seeks to identify factors that influence AFP levels, which may help in understanding liver cancer progression and improving diagnosis and treatment approaches.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 27 to 80 years.
* Diagnosed with hepatocellular carcinoma (HCC) within the last three months.
* Diagnosis confirmed by relevant investigations (e.g., imaging, liver biopsy).
* Able to provide informed consent.

Exclusion Criteria:

* Elevated alpha-fetoprotein levels due to tumors other than HCC.
* Presence of secondary liver metastases from other primary sites.
* Any significant comorbid conditions that could interfere with study assessments.
* Pregnancy or breastfeeding.
Immunomodulatory Effects of Silymarin in Patients With Beta-Thalassemia Major

A wide spectrum of immune abnormalities has been described by numerous studies involving β-thalassemic patients with multiple transfusions. The abnormalities observed are both quantitative and functional, and concern several components of the immune response. Flavonoids are phenolic compounds widely distributed in plants, which were reported to exert multiple biological effects, including antioxidant and free radical scavenging abilities. Silymarin, a flavonolignan complex isolated from milk thistle (Silybum marianum L. Gaertn), have been classified as cytoprotective, antioxidant, anti-inflammatory, and especially as hepatoprotective agents. Silymarin is already being used clinically for treatment of liver diseases.It is considered safe and well-tolerated, with reported adverse events similar to placebo. Several studies have also reported immunomodulatory actions of silymarin. It increases lymphocyte proliferation, interferon gamma, interleukin (IL)-4 and IL-10 secretions by stimulated lymphocytes in a dose-dependent manner. It has been shown that in vitro treatment of peripheral blood mononuclear cells with silymarin causes restoration of the thiol status and increases in T cell proliferation and activation. Because reactive oxygen species and iron overload play important roles in the pathophysiology of thalassemia, silymarin may be an effective therapy due to its antioxidant, immunomodulatory, cytoprotective and iron chelating activities. The present study designed to investigate the therapeutic activity of orally administered silymarin for treatment of β-thalassemia major, a well-known and prevalent disease in Iran, which is associated with oxidative stress, iron overload and immune abnormalities.


Eligibility Criteria:
Inclusion Criteria:

* Homozygous beta-thalassemia major
* Regularly blood transfusion
* Iron chelation therapy with subcutaneous desferrioxamine (DFO)40.0 mg/Kg/day for 5-7 days/week

Exclusion Criteria:

* Chronic hepatitis B infection
* Active hepatitis C infection
* A history of a positive HIV test
* Chronic renal or heart failure
* Iron chelation therapy with deferiprone
* Pregnancy
* Gastrointestinal conditions preventing absorption of an oral medication o
* noncompliance with prescribed therapy
Optimal Treatment Strategy Based on for Pediatric AML

The purpose of this study is to optimize therapy according to the known risk factors and treatment response in pediatric acute myeloid leukemia (AML)

I. Risk group assessment Favorable prognosis group: Low risk features + Good response

Intermediate prognosis group:

1. Low risk features + Delayed response-1
2. Standard risk features + Good response
3. Standard risk features + Delayed response-1

Poor prognosis group:

1. Any high risk features irrespective of treatment response
2. Any delayed response-2 irrespective of risk features
3. Any refractory state irrespective of risk features
4. Any early relapse

II. Chemotherapy Induction-1: Cytarabine + idarubicin Induction-2: High dose (HD) cytarabine + mitoxantrone Consolidation-1: Cytarabine + idarubicin Consolidation-2: HD cytarabine + etoposide Consolidation-3: HD cytarabine + mitoxantrone Consolidation-4: HD cytarabine + etoposide

III. Allogeneic hematopoietic stem cell transplantation (HSCT) Favorable prognosis group: chemotherapy only Intermediate prognosis group: chemotherapy or HSCT with reduced intensity conditioning Poor prognosis group: HSCT with myeloablative conditioning

Eligibility Criteria:
Inclusion Criteria:

* Patients who were newly diagnosed with de novo AML
* Patients who had recurrent cytogenetic abnormalities of AML even though the bone marrow blast percent is lower than 20%

Exclusion Criteria:

* Acute promyelocytic leukemia
* Down syndrome AML
* Therapy-related AML
* AML developed from myelodysplastic syndrome or other marrow failure syndrome
* Isolated myeloid sarcoma without bone marrow involvement
* Patients who cannot undergo chemotherapy as scheduled due to serious complications at diagnosis
Florbetaben PET Imaging in PPA

The purpose of this research is to better understand how dementia affects activity in different parts of the brain.

This study will examine Positron Emission Tomography (PET) imaging with Florbetaben F18. Florbetaben F18 is a radioactive tracer that binds to particles in your brain. This process displays activity in the brain. Florbetaben F18 is a PET amyloid imaging agent approved by the United States Food and Drug Administration (FDA) to estimate the amount of beta-amyloid plaque in adult patients who are being evaluated for Alzheimer's disease and other causes of cognitive decline. The purpose of this research is to better understand how dementia affects activity in different parts of the brain. Currently, the scientific community is limited by how well it can see inside the brain. The use of a PET scan better helps us understand what the brain looks like in a diseased state. Participation in the study will help to understand what brain activity looks like, especially around language regions.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a diagnosis of PPA or a related dementia syndrome

Exclusion Criteria:

* Pregnant
* Breastfeeding
* Receiving radiation clinically
Telerehabilitation in Patients With Fibrosing Interstitial Lung Diseases

The aim of the study is to determine the effectiveness of different exercise programs applied to 3 groups randomly formed in patients with fibrosing interstitial lung disease (FILD).

Secondary purpose: To determine the feasibility and effectiveness of telerehabilitation in FILD cases.

The cases meeting the inclusion criteria will be randomized and divided into three groups, the groups will be named as Telerehabilitation Exercise Group (TGr), Video Group (VGr) and Standard pulmonary rehabilitation group (SGr).TGr will be given online exercises, synchronized 2 days a week, and a home program for 1 day, accompanied by a physiotherapist, via videoconference on the group smartphone.After 1 session of online simultaneous exercise training in the company of a physiotherapist via a smart phone videoconference to the VGr group, an exercise video including the exercises will be sent to participants and the patients will be asked to do exercises 3 days a week. The participants will be asked to keep an exercise diary and the status of the diaries will be followed by phone call once a week.The SGr group will be applied the pulmonary rehabilitation program with supervision in the hospital 2 days a week, and participants will be asked to do exercises at home for 1 day. The exercise period will be 8 weeks for both groups.Details of the exercises to be applied to the cases are as follows: The exercise program includes aerobic, resistance exercises and breathing exercises.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-75
* Have a diagnosis of fibrosing interstitial lung disease diagnosed according to the clinical diagnostic criteria of the American Thoracic and European Respiratory Societies (ATS-ERS).
* Presence of dyspnea on exertion Stable clinical state at the time of admission without infection or exacerbation in the previous 4 weeks
* Ability to use a smart phone

Exclusion Criteria:

* Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy (˃ 3-4 L \\min).
* history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training.
* Participating in a pulmonary rehabilitation program within the past 12 months.
Genomic Analysis of Patients With Chronic Lymphocytic Leukemia

This study aims to characterize clonal evolution in chronic lymphocytic leukemia (CLL) using different approaches and to identify a possible association with disease progression, i.e. therapy initiation.

1. Samples This monocentric study is carried out using representative bioarchived leukemic samples with a diagnosis of CLL, either at diagnosis or at evolution. These bioarchived samples were collected locally at our center during years of diagnostic activity, and were accurately pathologically, cytogenetically and molecularly characterized.
2. Clinical data The clinical data were retrospectively collected through collaboration with the referring physicians.
3. Methods Samples will be investigated by means of (1) conventional cytogenetics, (2) fluorescence in situ hybridization (FISH) and (3) SNP-arrays. After analysis of the array data sets, significant results will be validated and in addition, results will be correlated with clinical data.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of CLL,
* at least two available stored samples

Exclusion Criteria:

* at least one inclusion criterium not fulfilled
Metronidazole and Amoxicillin for the Treatment of Type 2 Diabetic Subjects With Periodontitis

Diabetes mellitus (DM) is a widely prevalent disease associated with several major systemic and oral complications, such as periodontitis. The use of adjunctive local and/or systemic antimicrobials has been proposed to improve the clinical and glycemic outcomes of the scaling and root planing (SRP) in diabetic subjects. The combination of metronidazole (MTZ) and amoxicillin (AMX) has been largely recognized as an effective therapy for improving the clinical and microbiological outcomes of SRP in the treatment of with chronic periodontitis (ChP). However, no previous clinical trials to date have evaluated the effects of this antibiotic combination in the treatment of diabetic subjects with periodontitis. Therefore, the aim of this randomized clinical trial (RCT) will be to evaluate the clinical and microbiological effects of the use of MTZ+AMX as adjuncts to SRP for the treatment of type 2 diabetic subjects with generalized ChP.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 35 years of age
* Diagnosis of type 2 DM for ≥ 5 years
* DM treatment with diet and insulin supplementation or oral hypoglycemic agents
* Glycated hemoglobin (HbA1c) levels ≥ 6.5% ≤ 11%
* At least 15 teeth
* More than 30% of the sites with probing depth (PD) and clinical attachment level (CAL) ≥ 4 mm
* Minimum of six teeth with at least one site with PD and CAL ≥ 5 mm and bleeding on probing (BoP) at baseline.

Exclusion Criteria:

* Pregnancy
* Lactation
* Current smoking
* Smoking within the past 5 years
* Scaling and root planing (SRP) in the previous 12 months
* Antimicrobial therapies during the previous 6 months
* Medical conditions requiring prophylactic antibiotic coverage
* Continuous use of mouthrinses containing antimicrobials in the preceding 3 months
* Systemic conditions (except DM) that could affect the progression of periodontitis (e.g. immunological disorders, osteoporosis)
* Long-term administration of anti-inflammatory
* Long-term administration of immunosuppressive medications
* Allergy to metronidazole and/or amoxicillin
* Presence of periapical pathology
* Use of orthodontic appliances
* Presence of extensive prosthetic rehabilitation
* Major complications of DM (i.e. cardiovascular and peripheral vascular diseases \[ulcers, gangrene and amputation\], neuropathy and nephropathy)
OM and Trauma Study

The primary purpose of this study is to use an unblinded, uncontrolled, 1-month interventional single group pilot study, to assess the possibility of Orgasmic Meditation practice being used as a possible intervention for PTSD. The secondary purpose of this study is to examine if OM is associated with a decrease in the symptoms and self-assessed experiences associated with trauma.

The OM Trauma Protocol (OMTP) is designed to systematize the application of Orgasmic Meditation (OM) for individuals seeking relief from a wide variety of problems and/or help them in their pursuit of eudaimonia. The study protocol will evaluate whether OMing (the act of practicing OM) shows potential for being an effective intervention for people suffering from Post-Traumatic Stress Disorder (PTSD).


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years old
* One or more participants of the pair having a diagnosis of PTSD for \> 6 months
* Relationship for \> 6 months
* Self or partner of female sex
* Massachusetts residents
* Access and ability to use internet and a video platform called Zoom
* No history of doing the practice of OM

Exclusion Criteria:

* Ongoing or active use of illicit drugs at the time of the study
* Self-identify as pregnant
* Inability to speak English
* Recent hospitalization \< 12 months
* Suicidal ideation \< 12 months
* Self-harm \< 12 months
Open-Label of SPN-820 in Adults With Major Depressive Disorder

This study will evaluate the efficacy and safety of SPN-820 in Adults With Major Depressive Disorder (MDD)

This is an open-label, single-group study of adjunctive SPN-820 in adults with MDD

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject, aged 18 to 65 years (inclusive) at screening.
* Diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for either recurrent or single episode MDD without psychotic features that is confirmed by the Mini International Neuropsychiatric Interview (MINI) at screening.
* MADRS total score of ≥22 for the current major depressive episode (MDE) at screening and baseline (day 1) before SM administration.
* CGI-S score of ≥4 (moderately ill or worse) at screening and baseline (day 1) before SM administration.
* Stable, therapeutic dose of one of the following protocol-defined ADTs for the current MDE for ≥4 weeks prior to screening: citalopram, escitalopram, paroxetine, fluoxetine, sertraline, duloxetine, venlafaxine (immediate release or extended release), desvenlafaxine, vilazodone, levomilnacipran, vortioxetine, bupropion, or dextromethorphan/bupropion.
* Stable therapeutic dose of the approved ADT throughout the study.

Exclusion Criteria:

* MADRS total score improvement of ≥25% from the highest to the lowest score from screening to baseline.
* Clinically significant abnormal laboratory profiles, vital sign measurements, or ECGs prior to baseline.
* History of psychotic disorder, including but not limited to schizophrenia, MDD with psychotic features, or bipolar I/II disorder with and without psychotic features.
* Diagnosis within the last 12 months before screening or current diagnosis of PTSD, OCD, panic disorder, acute stress disorder, or has a history of intellectual disability, autism, or cluster A or B personality disorder.
* Suicidal behavior or suicidal ideation of type 4 or type 5 based on the C-SSRS in the 2 years before screening; a history of suicide attempt in the last 6 months; or more than 2 lifetime suicide attempts.
* History of substance use disorder within 6 months prior to screening or is currently using or has a positive result (urine drug screen) at screening or baseline for drugs of abuse.
* History of alcohol use disorder within 6 months prior to screening.
* In the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any other reason.
Intestinal Permeability in Children/Adolescents With Functional Dyspepsia

The main purpose of this study is to evaluate whether intestinal permeability and/or serum zonulin concentration is increased in children/adolescents with functional dyspepsia (FD). The study will also explore the relationships between intestinal permeability, mucosal inflammation and anxiety in FD patients.

Recurrent abdominal pain is a common complaint among school-age children, being present in up to 15% at any given time. It represents the most common chronic pain entity in pediatric patients. The great majority of these patients will have a functional gastrointestinal disorder (FGID). The most common FGID in these patients is functional dyspepsia (FD), defined as upper abdominal pain or discomfort unrelieved by bowel movement and in the absence of a structural or biochemical explanation for the pain. The etiology of FD is multifactorial, including biological factors, and these factors can be viewed within a biopsychosocial model. Biological factors include inflammation, dysmotility and increased visceral sensitivity. These biological factors are influenced by and are interactive with psychosocial factors such as anxiety, depression and social interaction. This study will evaluate intestinal permeability as a measure of barrier dysfunction and investigate the correlations between increased permeability, mucosal inflammation and anxiety scores to provide further insight into the etiology of FD, thereby assisting in the development and selection of treatment modalities.

Eligibility Criteria:
Inclusion Criteria:

* abdominal pain of at least 8 weeks duration and fulfilling Rome II symptom based criteria for functional dyspepsia (patient group only);
* undergoing endoscopy to evaluate FD following demonstration of a lack of clinical response to standard acid reduction therapy (patient group only); and,
* informed permission/assent

Exclusion Criteria:

* previous abdominal surgery;
* any chronic non-gastrointestinal illness requiring regular medical care (e.g. diabetes mellitus, juvenile rheumatoid arthritis, cystic fibrosis, cancer);
* any history of an adverse reaction to lactulose or mannitol;
* any use of antacids or laxatives within 1 week prior to the study;
* any use of steroids, antihistamines or antihistamine-like drugs within 4 weeks prior to the study;
* any use of aspirin is prohibited within one week prior to the study;
* any use of non-steroidal anti-inflammatory drugs (NSAIDs) other than aspirin is restricted within one week prior to the study or at the discretion of the Study Physician;
* any use of antibiotics including neomycin (Mycifradin) within 4 weeks prior to the study;
* pregnancy;
* any current or chronic history within the previous 6 months of gastrointestinal symptoms including abdominal pain or discomfort, nausea, vomiting, bloating, diarrhea or constipation (healthy control group only); or
* non-English speaking
CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema

The purpose of this study is to investigate the safety, PK / PD, and efficacy of SC CSL312 for prophylactic treatment of pediatric subjects with HAE.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Aged 2 to 11 years, inclusive, with body weight ≥ 10th percentile based on age
3. Diagnosed with clinically confirmed C1-INH HAE
4. Experienced ≥ 2 HAE attacks during the 6 months before Screening

Exclusion Criteria:

1. Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema, recurrent angioedema associated with urticaria, or HAE type 3
2. Use of C1-INH products, androgens, antifibrinolytics, approved or future approved medications, or other small molecule medications for routine prophylaxis against HAE attacks within a minimum of 2 weeks before the Treatment Period
3. Participation in another interventional clinical study during the 30 days before the Treatment Period or within 5 half-lives of the final dose of the investigational product administered during the previous interventional study, whichever is longer
4. Having laboratory clinical abnormalities assessed as clinically significant by the investigator in results of hematology or chemistry assessments performed during Screening
5. Currently receiving a therapy not permitted during the study
6. Being pregnant or breastfeeding.
Survey of Adolescent Living in Vestmanland

The interaction of MAO-A genotype and psychosocial risk, in relation to male adolescent criminality The interaction of 5-HTTLPR genotype and psychosocial risk in relation to excessive adolescent alcohol consumption The interaction of 5-HTTLPR genotype and psychosocial risk in relation to depressive symptoms among adolescents The interaction of MAO-A genotype and psychosocial risk, in relation to female adolescent criminality


Eligibility Criteria:
Inclusion Criteria:

All students present in school class during survey