cyrilzakka/clinical-trials huggingface dataset:
Systemic Inflammatory Markers in B-cell Neoplasm

This study was to evaluate the role of systemic inflammatory markers in predicting outcome for patients with B cell neoplasm

In malignant tumors, Inflammation plays a crucial role in the development, invasion, and metastasis of malignant tumors. Cancer is often described as a wound that does not heal, highlighting the significance of inflammation in cancer progression. Many tumors are heavily infiltrated by immune cells, including macrophages, neutrophils, and lymphocytes. Therefore, markers related to inflammation and the host immune response are pertinent as biological indicators of B-cell neoplasm progression. Inflammation contributes significantly to the initiation and advancement of B-cell neoplasms by providing nutrients to tumor cells, promoting cell growth, and disrupting immune homeostasis. Various composite indices based on circulating inflammatory cells have been developed as straightforward measures to assess systemic inflammation. Elevated serum inflammatory markers reflect the body's response to malignant tumors. Pro-inflammatory cytokines and inflammatory cells within the tumor microenvironment have been shown to promote tumor growth, induce DNA damage, facilitate angiogenesis, suppress the immune system, and correlate with poor patient survival outcomes. Targeting cytokine receptors or other components in inflammatory pathways involved in metastasis may offer therapeutic potential for malignant tumors. Given the pivotal role of inflammation in cancer biology, identifying novel immune markers is essential for predicting the prognosis of patients with Diffuse Large B-Cell Lymphoma (DLBCL). patients

Eligibility Criteria:
Inclusion Criteria:

* Individuals newly diagnosed with B-cell neoplasms, including:
* Burkitt's lymphoma (BL)
* Chronic lymphocytic leukemia (CLL)
* Diffuse large B-cell lymphoma (DLBCL)
* Follicular lymphoma (FL)
* Hairy cell leukemia (HCL)
* Splenic B-cell lymphoma/leukemia with prominent nucleoli (SBLPN)
* High-grade B-cell lymphoma (HGBL)
* Lymphoplasmacytic lymphoma (LPL)/Waldenström macroglobulinemia
* Mantle cell lymphoma (MCL)
* Splenic marginal zone lymphoma (MZL)
* Monoclonal B-cell lymphocytosis (MBL)
* Multiple myeloma (plasma cell myeloma)
* Monoclonal gammopathy of undetermined significance (MGUS)
* Age 18 years or older.

Exclusion Criteria:

* Individuals previously diagnosed with B-cell neoplasms.
* Individuals younger than 18 years.
Pentoxifylline and Systemic Inflammation in Hemodialysis Patients

The aim of this study was to compare the effect of PTX vs placebo on serum concentrations of TNF-α, IL-6, and CRP in patients on hemodialysis.

Patients were randomly selected from the total HD patients of our hospital. Once included, patients were randomly allocated (by a computer-generated randomization list) to a study or control group. Over a period of 4 months, patients of the study group received one PTX tablet (400 mg) orally once a day (at dinner time), whereas controls received one starch identical tablet on the same schedule.

All patients had three HD sessions per week, with the same kind of single-use dialysis membrane and dialysate. Monthly visits were scheduled for clinical and biochemical evaluations. A blood sample was taken at baseline and every month for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids, and electrolytes (measured by usual methods). In serum samples at 0, 2 and 4 months, TNF-α and IL-6 concentrations were measured by ELISA using high sensitivity kits (Amersham Pharmacia Biotech, Buckinghamshire, UK). Additionally, in the same serum samples, CRP concentrations were measured by nephelometry using high sensitivity kits (Dade Behring, Marburg, Germany) in a Nephelometry Analyzer II (Dade Behring, Marburg, Germany). All laboratory measurements, including inflammation markers, were performed in the Central Laboratory (Hospital de Especialidades, CMNO), by the same personnel blinded to patient's details.

Treatment compliance was recorded by counting tablets left in the container at the end of each monthly visit.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years,
* ≥2 months on HD,
* arteriovenous fistula as vascular access, and
* endorsement of informed consent.

Exclusion Criteria:

* inflammatory cause of ESRD,
* liver disease, cancer, AIDS,
* any infectious disease 2 months before the study,
* failed kidney graft,
* hypersensitivity to PTX or other methylxanthines,
* hemorrhage/clotting disorders,
* risk for worsening pre-existing cardiac arrhythmias or arterial hypotension,
* treatment with antibiotics, non-steroidal anti-inflammatory drugs, steroids, immunosuppressives, statins or PTX 3 months previous to the study
Study of Docetaxel/Gemcitabine Followed by Chemo-radiotherapy (Chemo-RT), With or Without Consolidation Chemotherapy, in IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)

The combination of chemotherapy with radiotherapy remains the standard of therapy for patients with stage III NSCLC. A recent phase II study has presented encouraging data regarding the administration of docetaxel as consolidation treatment after definitive concurrent chemo-radiotherapy.

To evaluate whether the administration of consolidation therapy with docetaxel/carboplatin after induction chemotherapy followed by concurrent chemoradiotherapy, offers any advantage regarding time to tumor progression

Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed, unresectable locally advanced (stage IIIA/IIIB) NSCLC
* no previous therapy for NSCLC is allowed
* age \>18 years
* bidimensionally measurable disease
* performance status (WHO) 0-2
* absence of pleural effusion
* adequate liver (serum bilirubin \< 1.5 times the upper normal limit (UNL); AST and ALT \< 2.5 times the UNL in the absence of demonstrable liver metastases, or \< 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine \< 1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
* life expectancy of more than 3 months
* written informed consent

Exclusion Criteria:

* active infection
* history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* malnutrition (loss of ≥ 20% of the original body weight)
* performance status: 3-4
* sensor or motor neuropathy \> grade I
* second primary malignancy, except for non-melanoma skin cancer
* psychiatric illness or social situation that would preclude study compliance
* pregnant or lactating women
A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies

A study to assess the effect of multiple doses of venetoclax on the pharmacokinetics of ethinyl estradiol and levonorgestrel in female participants with different hematological malignancies. Upon completion of this study, participants receiving clinical benefit in the opinion of the investigator and without any clinically significant evidence of disease progression with no access to venetoclax (not approved for the treated indication) may continue receiving venetoclax at the discretion of the investigator in a separate extension study.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have relapsed or refractory non-Hodgkin's lymphoma (NHL).
* Participant must have histologically documented diagnosis of one of the following NHL subtypes: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), lymphoplasmacytic lymphoma (LPL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), T-cell prolymphocytic lymphoma (T-PLL), Waldenström's macroglobulinemia (WM)
* Has an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to two.
* Must have adequate bone marrow, coagulation, renal and hepatic function as described in the protocol.
* A female of non-childbearing potential as described in the protocol.

Exclusion Criteria:

* History of currently active, clinically significant cardiovascular disease.
* If the participant has had prior stem cell transplantation, it must have been more than 100 days prior to start of study drug, with no graft versus host disease, and no immunosuppression therapy.
* evidence of transformation of the lymphoma immediately prior to study entry.
* Evidence of central nervous system involvement by lymphoma.
Randomized Trial of Docetaxel and Gemcitabine Versus Gemcitabine in Elderly Patients With NSCLC

This trial will compare the efficacy of the docetaxel and gemcitabine combination versus monotherapy with gemcitabine as first-line treatment in elderly patients with advanced NSCLC

Docetaxel and gemcitabine are well known active agents in the treatment of NSCLC. The standard treatment of elderly patients with advanced NSCLC is monotherapy with a third generation agent. However, there are only few randomized trials evaluating a two drug combination specifically addressed to elderly patients. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation

Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer
* Stage IIIB/IV
* No prior chemotherapy
* Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated.
* Absence or irradiated and stable central nervous system metastatic disease
* Life expectancy of more than 3 months
* Age ≥ 70 years.
* Performance status (WHO) \< 3
* Patients "non-frail" according to comprehensive geriatric assessment
* Adequate bone marrow function (Absolute neutrophil count \> 1000/mm\^3, Platelet count \> 100000/mm\^3, Hemoglobin \> 9gr/mm\^3).
* Adequate liver (Bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl).
* Adequate cardiac function (LVEF \> 50%).
* Informed consent.

Exclusion Criteria:

* Psychiatric illness or social situation that would preclude study compliance.
* Other concurrent uncontrolled illness.
* Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
* No presence of a reliable care giver
* Other concurrent investigational agents.
A Registry of Peripartum Cardiomyopathy in Turkey

Peripartum cardiomyopathy (PPCM) is a global disease with significant morbidity and mortality of young women. Its' etiology, epidemiology and treatment is not yet well described. This will be a retrospective, national, multicenter observational study, conducted in Turkey. It is expected that approximately 50 women with PPCM will be recorded.

Peripartum cardiomyopathy (PPCM) is a global disease with significant morbidity and mortality of young women. Its' etiology, epidemiology and treatment is not yet well described. This will be a retrospective, national, multicenter observational study, conducted in centres in Turkey. It is expected that approximately 50 women with PPCM will be recorded.

The objectives of the study are:

To define the clinical status and clinical characteristics of PPCM in Turkey

To define the outcome of PPCM (short and long term)

To define the demographical and possible etiological factors

To define prognostic factors

Eligibility Criteria:
Inclusion Criteria:

* Patient above 18 years of age
* Unexplained Heart Failure symptoms developed towards the end of pregnancy or in the first 6 months of postpartum period
* Ejection fraction less than 45% documented with echocardiography

Exclusion Criteria:

* Patients with any other known cardiac pathology
Arthroscopic Versus Conservative Treatment of Degenerative Meniscal Tear in Middle Aged Patients in Regard to Pain & Knee Function

The study is prospective comparative study, conducted in Erbil teaching hospital on 60 patients, their age ranging between 40 and 60 years. All were clinically diagnosed to have degenerative medial meniscal tear then confirmed by MRI. Thirty patients were treated conservatively, thirty patients were treated arthroscopically.


Eligibility Criteria:
Inclusion Criteria:

1. Atraumatic continuous pain in medial aspect of knee affecting daily activities, for more than one month despite the treatment of general physician.
2. Grade 3 degenerative tear of medial meniscus approved on MRI.

Exclusion Criteria:

1. Meniscal tear due to trauma.
2. Any rheumatologic knee disease.
3. MRI showing ligament injury, loose bodies, tumors and osteochondral defects.
4. Former surgery of knee and lower limb fractures in the last year.
5. Knee joints with osteoarthritis graded 2 or more according to Kellgren-Lawrence scale (Kellgren and Lawrence, 1957) on weight-bearing knee x-ray.
6. Lateral meniscus tear.
Thoracoscopy for Idiopathic Pneumothorax in Children

The goal of this retrospective study is to describe the outcomes of spontaneous idiopathic pneumothorax treated by thoracoscopy with pleural abrasion and blebectomy.

The main questions it aims to answer are:

* are there risk factors leading to pneumothorax recurrence?
* are pleural abrasion and blebectomy really diminishing the recurrence of pneumothorax?

The investigators describe the outcomes of the participants: length of stay, operating time, type and time before recurrence, occurrence of contralateral pneumothorax also treated by thoracoscopy, with pleural abrasion and blebectomy

Eligibility Criteria:
Inclusion Criteria:

* Patients younger than 18 years old who had a video-assisted thoracoscopy with pleural abrasion and blebectomy for spontaneous idiopathic pneumothorax

Exclusion Criteria:

* Patients older than 18 years old who had a video-assisted thoracoscopy with pleural abrasion and blebectomy for spontaneous idiopathic pneumothorax
Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel-coated Devices (SAFE-PAD Study)

The SAFE-PAD Study aims to evaluate the long-term safety of paclitaxel-coated devices compared with non-paclitaxel-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with peripheral artery disease. This multi-year analysis aims to create an ongoing mechanism to evaluate the safety of paclitaxel-coated devices in real world practice. The null hypothesis is that the paclitaxel-coated devices are associated with an increase in mortality relative to the non-drug-coated devices beyond an acceptable magnitude (i.e. the non-inferiority margin), and the alternative hypothesis is that paclitaxel-coated devices are not associated with an increase in mortality relative to the non-drug-coated devices beyond the non-inferiority margin.

This is an observational retrospective cohort study using claims data to evaluate the long-term safety of paclitaxel-coated devices compared with non-drug coated devices for femoropopliteal artery revascularization, with median follow-up time for the population surpassing 5 years. A series of supplemental sensitivity analyses will be conducted to assess and mitigate the potential for unmeasured confounding and to determine the impact of repeat interventions and paclitaxel exposure on survival. Finally, sub-group analyses will be performed to investigate whether there is differential safety of paclitaxel-coated devices across different patient profiles.

Eligibility Criteria:
Inclusion Criteria:

* All fee-for-service Medicare beneficiaries who underwent femoropopliteal artery revascularization. Patients are allowed to undergo simultaneous revascularization of lesions outside this target vessel during the same procedure.
* All patients with ≥1 year of Medicare claims data prior to their index procedure.

Exclusion Criteria:

* Patients without 1 year of Medicare claims data prior to their index revascularization procedure.
* Patients that do not have both a carrier file charge and an institutional file charge on the date of an outpatient procedure. This removes procedures performed in certain clinical settings, such as office-based clinics, that do not submit the Healthcare Common Procedure Coding System (HCPCS) code needed to identify drug-coated devices.
Testing of the Integrated Rapid Access to HIV Prevention Program for People Who Inject Drugs Program

This is a pilot study of an integrated rapid access HIV prevention program for People who inject drugs (PWID) called iRaPID. The program incorporates same-day access to Pre-exposure Prophylaxis (PrEP) and Opioid Agonist Therapy (OAT).

A Hybrid type 1 implementation science design,will be used to pilot test the APN-led iRaPID program while exploring information on its implementation at multiple time points through the study. The hybrid type 1 pilot trial provides an implementation heuristic to assess potential research questions, perhaps more comprehensively, accurately and certainly earlier than could be achieved in a sequential 'intervention-then-preliminary-pilot study' strategy. In this hybrid type 1 pilot trial, the RCT will be utilized to:

* Examine feasibility and acceptability among PWID and clinical stakeholders for an adapted APN-delivered, rapid HIV prevention program for PWID (iRaPID) that integrates same-day PrEP and OAT.
* Estimate the preliminary efficacy of PrEP and OAT uptake in a pilot randomized controlled trial of the iRaPID vs. treatment as usual strategy in PWID without HIV.

To assess future scale-up factors, the Consolidated Framework for Implementation Research (CFIR) will be utilized with the nominal group technique (NGT). It is a conceptual framework developed to guide the assessment of multilevel implementation contexts. The CFIR framework was selected because it provides a structured menu of constructs associated with effective implementation. It consists of 5 domains with 39 underlying constructs. As recommended by Damschroder, in this study 8 CFIR constructs based on the relevancy will be measured.

During the NGT, participants will be asked questions related to the multi-level implementation factors that will be based on the sample guide available on http://cfirguide.org but tailored for PWID. After posing each question, participants silently generate individual ideas. Then, using a round-robin elicitation process, each person contributes ideas that are recorded visually. They then engage in group discussion to clarify and evaluate the ideas. Items are then grouped by consensus with duplicate items removed. Then, each participant casts three votes on items as they deem them important. Votes are immediately tallied, ranked based on total number of votes, and the facilitator leads a final discussion to review the results. Sessions will take 60 minutes and be audio-recorded and transcribed.

Eligibility Criteria:
Inclusion Criteria:

PWID

1. Age ≥18 years
2. HIV-negative
3. Reporting injection drug use (past 3 months)
4. Substantial ongoing risk for HIV acquisition
5. OUD based on the DSM-V criteria

Stakeholders

1. Age ≥18 years
2. APNs, patient navigators, counselors, and administrators who reflect the range of characteristics of staff members that are involved in HIV care to PWID

Exclusion Criteria:

PWID and stakeholders

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Unable to provide informed consent
2. Unable to read and understand English
Assessment of Long-Term Infliximab for Psoriasis (P05319)

This is a prospective Phase 4, open-label, non-randomized, observational, multi-center study of infliximab in participants with plaque-type psoriasis to assess the clinical response in real-world practice of long-term maintenance therapy with infliximab 5 mg/kg body weight in a psoriasis population, prescribed in a regimen in accordance with the product monograph (PM) for Canada, the approved summary sheet of product characteristics (SPC) for countries in the European Union (EU), or per label according to local guidelines for all other participating countries.

This study will be conducted in two phases: the 50-week treatment period and the 48-week extended treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Participant must have a diagnosis of plaque-type psoriasis
* Participant's physician must have decided, with the subject's consent, to start treatment with infliximab
* Participant must demonstrate willingness to participate in the study and agree with the procedures of the study by signing the written informed consent
* For inclusion into the extended treatment period, participant must have completed 50 weeks of infliximab treatment in the treatment period
* For inclusion into the extended treatment period, participant must be continuing treatment with intravenous infliximab
* For inclusion into the extended treatment period, participant must have an improvement in their PASI score of greater than or equal to 25% at the time of entry into to the extended treatment period

Exclusion Criteria:

For the Treatment Period

* Given the non-interventional nature of the study, no specific exclusion criteria will be applied to a participant so long as the participant is eligible for the trial (Inclusion Criteria). The treating physician is expected, as in normal clinical practice, to follow the PM (Canada), the approved SPC (EU), or local labeling (for all other participating countries) regarding contraindications and precautions

For the Extended Treatment Period

* Given the non-interventional nature of the study, no specific exclusion criteria will be applied to a participant so long as the participant is receiving infliximab treatment in accordance with the PM (Canada), the approved SPC (EU), or local labeling (for all other participating countries) regarding contraindications, precautions, dosing and frequency of administration
The Model for End-Stage Liver Disease Sodium (MELD-Na) Score in Non-cirrhotic Patients With Gastric Cancer

Gastric cancer is the fifth most common cancer worldwide. Gastrectomy with lymphadenectomy is still the most effective treatment modality, depending on the stage and location. Despite many radiological, surgical and anesthetic innovations, serious complications such as anastomotic leakage, intra-abdominal abscesses, wound complications are seen secondary to gastrectomy. Many clinical studies have been conducted to prevent and predict these complications.

The Model for End-Stage Liver Disease (MELD) score, in which bilirubin, international normalized ratio (INR) and serum creatinine values were used to determine surgical risks in patients scheduled for liver transplantation. Latter developed by adding serum sodium (Na) to the formula. The MELD-Na score is used to predict postoperative complications in non-cirrhotic patients because of its simple and easy calculation.Moreover, The Meld-Na score was later used to predict complications for surgical procedures other than liver surgery such as colorectal surgery.

In this study, we aimed to investigate the importance of the Meld-Na score in predicting the perioperative and postoperative outcomes in patients with gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing gastrectomy due to gastric cancer

Exclusion Criteria:

* Patients with pulmonary, hepatic and renal disfunctions,
* Patients with diagnosed with a different cancer in the last 5 years and
* Pregnant patients