cyrilzakka/clinical-trials huggingface dataset:
A Clinico-Pathological Study to Investigate the Possible Infective Causes of Non-Hodgkin Lymphoma of the Ocular Adnexae

Patients with mucosa-associated lymphoid tissue (MALT) lymphoma of the ocular adnexae (MLOA) will be eligible for treatment with doxycycline (part A: clinico-pathological study); patients with other types of ocular lymphoma, inflammatory lesions or those ineligible/unwilling for treatment with doxycycline can participate in the only pathologic study (part B).

Patients with suspected lymphoma of the ocular adnexae will undergo a diagnostic biopsy in the usual way. If lymphoma is confirmed the patient will undergo a full staging evaluation and entry into either part A or B of the study will then be considered as follows:

* clinico-pathological (part A) for patients with MALT lymphoma of the ocular adnexae (MLOA) and eligible for treatment with Doxycycline 100 mg twice daily for 3 weeks ; or
* pathology only (part B) for patients with other types of ocular lymphoma, inflammatory lesions or those ineligible/unwilling for treatment with doxycycline.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or over
2. Histologically confirmed marginal zone B-cell lymphoma of MALT-type
3. Lymphoma localised to the ocular adnexae (conjunctiva, lacrimal gland, orbit soft tissue, clinical stage IEA) following a CT scan of neck, thorax, abdomen and pelvis, bone marrow aspirate/trephine, full blood count and biochemical profile
4. No previous treatment, excepting RT for localised lymphoma of the contralateral eye
5. At least one measurable lesion
6. No systemic antibiotic therapy in the last three months
7. No other malignancy in the previous 5 years apart from appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
8. In women with reproductive potential a willingness to use contraception from entry into the study for a period of 3 months
9. Written informed consent

Exclusion Criteria:

1. Pregnant or lactating women
2. Known allergy to tetracycline
3. Patients unwilling to comply with the requirements of follow-up as defined by this protocol
4. Myasthenia gravis (tetracycline can exacerbate muscle weakness)
5. Systemic lupus erythematous (tetracycline can exacerbate the condition)
6. Patients with large or rapidly enlarging tumours requiring immediate radiotherapy
Study of Methodologies to Measure Blood Flow and Oxygenation in Adults With Sickle Cell Disease

The purpose of the study is to determine whether imaging techniques, such as magnetic resonance imaging (MRI), near infrared spectroscopy (NIRS), laser speckle contrast imaging (LSCI), and optical imaging (OI), can detect differences in blood flow and oxygen levels in different organ systems of participants with sickle cell disease (SCD). Differences in blood flow and oxygen levels detected by these techniques will be evaluated to determine their utility as biomarkers of clinical disease pathophysiology.


Eligibility Criteria:
Key Inclusion Criteria:

1. Have a diagnosis of SCD confirmed by hemoglobin analysis.
2. Be in stable clinical condition, as determined by the Investigator.

   Subjects enrolled in Part B must also meet the following eligibility criterion at Screening:
3. Receiving scheduled standard of care RBC exchange transfusion therapy, with ≥3 transfusions already received.
4. Be deemed healthy, as determined by the Investigator, based on the physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory measurements.

Key Exclusion Criteria:

1. Inability to lie still for ≥5 minutes, claustrophobia sufficient to interfere with generating reliable MRI scans, body weight exceeding 320.0 lbs., or girth exceeding the magnet bore.
2. Presence of a metal device affected by MRI (e.g., any type of electronic, mechanical or magnetic implant, cardiac pacemaker, aneurysm clips, implanted cardiac defibrillator) or potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) which would be a contraindication for MRI.
3. Acute pain crisis requiring hospitalization, with a discharge ≤4 weeks prior to the first imaging visit, or when determined by the Investigator to not be at steady state.
4. Recent (≤3 months) treatment with hydroxyurea therapy.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®

This study is designed to compare skin reactions with or without the use of warm compress prior to performing a Copaxone® injection.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female, 18 years or older, with a diagnosis of RRMS
2. Willing and able to complete all procedures and evaluations related to the study.
3. Willing to provide Informed Consent

Exclusion Criteria:

1. Taking any other immunomodulatory therapy in conjunction with Copaxone®.
2. Has a significant medical illness other than MS which may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study.
3. Any situation which the investigator or nurse feels may interfere with participation in the study.
4. Pregnant, or trying to become pregnant, or breast feeding during the study.
5. Previously participated in this study.
The Acute and Long-term Clinical Outcome of Self- Expandable Stent in Complex Proximal Superficial Femoral Artery Lesions Involving the Femoral Bifurcation

The stent-FP study investigates the impact of coverage of profound femoral artery (PFA) by bare metal stent deployed in proximal superficial femoral artery (SFA) lesions. 300 patients with femoral bifurcation lesions will be included and divided into 3 groups according to the location of proximal stent edge. The primary endpoint of the study is major adverse events and freedom from target lesion revascularization at 48 months. Secondary endpoints include primary patency of PFA and bare metal stent at 1,6, 12,24,36and 48 month, MAE and F -TLR at 1,6, 12,24,36 month.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic atherosclerosis obliterans aged over 18 years
2. Patients presenting Rutherford classification from 2-5
3. Patients is willing to follow-up on time
4. Patient has a life expectancy of at least 24 months
5. Prior to enrolment, the guidewire has crossed target lesion
6. De novo lesions located in the femoral artery bifurcation (5mm between distal CFA and proximal SFA), need for primary bare metal stent implantation
7. There is a patent deep femoral artery demonstrated by angiography
8. If the first-time endovascular treatment is failure, patients undergo endovascular treatment successfully at the second time, the patients can still be enrolled （9）For patients with aortoiliac artery lesions, they can be enrolled after the successful reconstruction of aortoiliac artery .

(10) The lower extremity artery needs to have a healthy runoff of no less than 10 cm above the ankle, and at least one healthy dorsalis pedis artery, medial or lateral plantar artery connected with the digital artery below the ankle (11) Informed consent signed by patients

Exclusion Criteria:

1. Patients who are known to be allergic to heparin, low molecular weight heparin, contrast agents, etc.
2. In the past 3 months, they have participated in other drugs that interfere with this clinical trial or patients in clinical trials of medical devices
3. Pregnant and lactating women
4. Patients with other diseases that may make the trial difficult or significantly shorten the patient's life expectancy (\<2 years), such as tumors, severe liver disease, cardiac insufficiency, etc or patients whose life expectancy is less than 24 months (24 months of follow-up are required)
5. Patients with acute arterial thrombosis or embolism at the target lesion site.
6. Patients who underwent stent implantation in common femoral artery previously

(8) Use of thrombectomy, atherectomy or laser devices during procedure (9) Previous open surgery in the same limb . (10) Patients with deep femoral artery totally occlusion
The Effects of Dexmedetomidine on Thiol/Disulphide Homeostasis in Coronary Bypass Surgery

Dexmedetomidine (DEX) is a sedative and anesthetic drug with known antioxidant properties.In this study, it was aimed to investigate the oxidative stress levels in patients undergoing on-pump CABG by measuring the thiol/disulfide levels and to investigate the effects of dexmedetomidine infusion used in Coronary Bypass Surgery on dynamic Thiol/Disulphide Homeostasis.

It is well known that cardiovascular disease is the leading cause of increased morbidity and mortality worldwide. One of the key surgical procedures that patients with coronary artery disease (CAD) are often subjected to is coronary artery bypass grafting (CABG). However, the cardiopulmonary bypass (CPB) pump increases systemic oxidative stress . High levels of molecular oxygen enter the body during cardiopulmonary bypass (CPB) and reperfusion, followed by inflammation leading to the formation of free oxygen radicals which causes lipid peroxidation, ultimately resulting in an oxidative attack at the cell and tissue level.

Thiols are organic sulphur derivatives containing Sulfhydryl Residues (-SH) in their active regions. Thiols easily react with oxygen containing free radicals to form disulfides. This is a defence mechanism against oxidative stress.7 An automated analysis quantitatively measuring serum native and total thiol, and disulfides has been recently described as a method to determine dynamic Thiol/Disulfide Homeostasis (TDH).The role of dynamic thioldisulfide homeostasis has been increasingly shown in many diseases. There is a growing number of evidences that an abnormal thiol-disulfide homeostasis may play role in the pathogenesis of a variety of diseases such as cardiovascular disease, malignancies, rheumatoid arthritis, chronic kidney disease, and acquired immunodeficiency syndrome.

Dexmedetomidine (DEX) is a sedative and anesthetic drug with known antioxidant properties.In this study, it was aimed to investigate the oxidative stress levels in patients undergoing on-pump CABG by measuring the thiol/disulfide levels and to investigate the effects of dexmedetomidine infusion used in Coronary Bypass Surgery on dynamic Thiol/Disulphide Homeostasis.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone coronary bypass surgery using a cardiopulmonary pump
* Patients who agreed to participate in the study

Exclusion Criteria:

* Bypass surgeries without cardiopulmonary pump
* Patients with intraoperative unexpected/undesirable complications
* Patients who did not agree to participate in the study
* Patients with missing data
Optimizing Cellular and Humoral Immunity by Vaccinating With PCV13 Before and After CAR-T Therapy

The purpose of the study is to evaluate whether receiving the pneumococcal 13-valent conjugate vaccine (PCV13) before and after CD19-targeted CAR T cell therapy will optimize cellular and humoral immunity to pneumococcus.

This is a phase II, single-institution study to investigate if pneumococcal vaccination before and after CD19-targeted CAR T cell therapy elicits cellular and humoral immunity to pneumococcus in patients with relapsed or refractory B cell lymphomas. All the participants will receive the same treatment. Immunoglobulins (IgG) against pneumococcal serotypes not included in the vaccine will be served as an internal control. Treatment includes the same dose (0.5ml) of PCV13 one time prior to apheresis followed by two times after CAR T cell therapy

Eligibility Criteria:
Inclusion Criteria:

* In good health as evidenced by medical history or diagnosed with relapsed or chemotherapy-refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMLBCL), transformed follicular lymphoma (TFL) high-grade B cell lymphoma (HGBCL) or Follicular Lymphoma. Patients must be under consideration for treatment with any CD19-targeted CAR T cell therapy, per institutional standards. Patients undergoing active vital organ testing with a planned apheresis date for CAR T cell therapy may be considered eligible.
* Signed informed consent form in accordance with institutional and federal law policies
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, age over 18
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

Exclusion Criteria:

* Pregnant or lactating woman, as evaluated by serum testing within 2 weeks of administration of the first vaccine. Only women of childbearing potential will undergo serum/urine pregnancy testing. A woman will be considered of childbearing potential unless she is status-post hysterectomy or tubal ligation or without menstrual periods in the preceding 12 months.
* Common variable immunodeficiency or other inherited systemic immunodeficiency syndrome
* History of severe allergy (e.g., anaphylaxis) to any component of pneumococcal conjugate vaccine 7 valent (PCV7), PCV13, or any diphtheria-toxoid containing vaccine.
* Inclusion on a separate trial in which patients may be randomized or otherwise started on maintenance chemotherapies within the first 3 months of CD19-targeted CAR T cell therapy
* Patients with significant psychiatric illness likely to affect compliance, as determined by the treating physician
* Active or uncontrolled infections
* Platelet count \<10,000 cells/microliter
* Lymphocyte count \<200 cells/microliter
* Intervenous immunoglobulin (IVIG) administration within one month of planned apheresis for collection for CD19-targeted CAR T cell manufacture
* History of PCV13 administration within one month of planned apheresis for collection for CD19-targeted CAR T cell manufacture
The Effectiveness of Walking in Patients With Systemic Lupus Erythematosus

Expected Results:

Finding from this evidence-based study ought to clarify the effectiveness of walking intervention for patients with SLE, and provide reference for future nursing strategies to improve disease adaptability.

Background and purpose:

Walking exercise may be grateful in strengthening the cardiopulmonary function, regulating the joint flexbility, relieving the pain and the disturbance of sleep, all of which can further improve the quality of life among the patients with chronic diseases. Nevertheless, the information regarding the effect of walking exercise amongst systemic lupus erythematosus (SLE) subjects is still obscure. This study aimed to the influence of quality of life and sleep after the implementation of walking exercise among such groups.

uses the Psychometric evaluation of the Chinese version of the Pittsburgh Sleep QualityIndex、Systemic Lupus Erythematosus-Specific Quality of Life Questionnaire and Systemic Lupus Disease Activity of Lupus Erythematosus Disease Activity Score and Taiwanese Depression Questionnaire to evaluate the effectiveness of the intervention of walking exercise on Systemic lupus erythematosus.

Methods:

Through the quasi-experimental study design, the investigators intend to recruit the SLE patients from a hospital in Taiwan between 2021-2022. The main intervention is composed of home walking, which contained walking guidance and telephone consultation. After that, the investigators apply the structured questionnaires and existing data to collect performance indicators, covering the Chinese version of Pittsburgh Sleep QualityIndex, Systemic Lupus Erythematosus-Specific Quality of Life Questionnaire, Systemic Lupus Disease Activity of Lupus Erythematosus Disease Activity Score, and Taiwanese Depression Questionnaire. The effects of walking exercise is determined by The generalized estimation equations(GEE) .

Eligibility Criteria:
Inclusion Criteria:

* patients with fulfilled the American College of Rheumatology 1997 criteria for SLE

Exclusion Criteria:

* .patients with cardiovascular disease
* limited motion, such as bed-ridden, femur head necrosis
* were pregnant, or had a depressive disorder,
Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation

This is a Phase 1, Single-Centre, Open-Label, Two-Part, Sequential Cross-Over Study Designed to Assess the Pharmacokinetic Profile of BLU-5937 Following Administration of Extended Release Formulation Prototypes and an Immediate Release Reference Formulation in Healthy Male and Female Subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating healthy females

Exclusion Criteria:

* History of clinically significant cardiovascular, renal, hepatic, metabolic, dermatological, respiratory, GI, neurological, endocrine, haematological, immunological or psychiatric disorder, as judged by the investigator.
An Integrated Optimization of Surgery and Radiotherapy Techniques to Improve Cosmetic Outcome and Quality of Life in Breast Conserving Therapy for Breast Cancer Patients (STARLINGS Study)

To assess the role of different combinations of (oncoplastic) surgery and radiotherapy techniques as risk factors for moderate to severe fibrosis and for moderate to poor cosmetic outcome.

The primary objectives of this study are to assess the role of different combinations of (oncoplastic) surgery and radiotherapy techniques as risk factors for moderate to severe fibrosis and for moderate to poor cosmetic outcome. Based on these insights predictive models for the development of moderate to severe fibrosis and moderate to poor cosmetic outcome will be developed. Second, the relation between the presence and severity of fibrosis, cosmetic outcome and different QoL domains and symptoms will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged ≥ 18 years
* History of BCT with adjuvant radiation therapy for non-metastatic, histologically proven invasive breast cancer or DCIS. In light of BCT adjuvant systemic treatment (i.e. endocrine therapy, chemotherapy and immune therapy) is allowed.
* Operated between 1st of January 2016 and 31th of December 2020
* Treated according to the currently applied dose fractionation schedules, i.e. whole breast radiotherapy (22, 23), with or without boost
* Adequate understanding of the Dutch language and written informed consent

Exclusion Criteria:

* Any breast surgery or re-irradiation on the breast area after BCT
* Progression of disease (and additional treatment) since BCT
* Patients who received partial breast irradiation
* Current pregnancy or breast feeding
Immune Response to Pneumococcal Polysaccharide Vaccine (23-valent) Predicts Asthma Status and Outcomes in Late Adolescents With Asthma

Advisory Committee for Immunization Practices (ACIP) from the Centers for Disease Control (CDC) recommends that children (6-18 years) and adults (≥19 years old) with chronic lung condition such as asthma or cigarette smoking be vaccinated with Pneumococcal vaccine (PPSV23). The purpose of this study is to increase awareness of vaccination to late adolescents with asthma and smokers (social aspect of study), and to recommend vaccination (which is the clinical aspect). Individuals who agree to receiving vaccine will be enrolled in research to determine whether late adolescents with and without asthma (smokers) have distinctive pneumococcal vaccine response patterns and whether such patterns are associated with subsequent variance in asthma outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Reside in Olmsted County, Minnesota (defined by Olmsted County address in medical record within one year prior to last follow-up date as of data abstraction)
* Receive medical care from Mayo Clinic clinical practice
* Signed research authorization for using medical record for research

Exclusion Criteria:

* Diagnosis of an immunodeficiency (primary and secondary)
* Previous or current diagnosis of a Rheumatological disorders (Rheumatoid arthritis, Lupus, Sjögren, and vasculitis), cancer (chronic lymphocytic leukemia, non-Hodgkin lymphoma, and B-cell malignancy), diabetes, active infection (pneumonia, otitis media, HIV, and EBV), other chronic diseases (multiple sclerosis, etc), renal disease such nephritic syndrome, and protein losing enteropathy
* Current or previous use (within the last 6 months) of systemic corticosteroids, and other immunosuppressive agents (cyclosporin, methotrexate, and mycophenolic acid)
* Vaccination of PPSV-23 (receiving childhood pneumococcal vaccination during infancy is eligible for this study)
* Pregnancy

Enrollment will be delayed 2 weeks for those subjects that can be included but have upper respiratory infection or viral illness to allow for natural resolution.
Watching Live VIA/VILI Examinations on a Digital Screen May Reduce Patients' Anxiety

The purpose of this study is to assess whether the degree of anxiety experienced by women undergoing visual inspection with acetic acid (VIA) and Lugol's iodine (VILI) can be reduced by watching the procedure in real-time on a digital screen.

The study took place in the District of Dschang, Cameroon. Women aged between 30 and 49 years, addressed to undergo a pelvic examination with VIA and VILI, were invited to participate. Throughout the examination, one part of the women underwent the routine VIA/VILI, with no visual support (control group), whereas the other part of patients were shown the pictures of the cervix in real-time on a digital screen (study group). At the end of the procedure, all women had the possibility to see the pictures retrospectively. Randomization determined the women's distribution between the two groups. Their anxiety level was measured by asking them to complete the Spielberg's State Anxiety Inventory (STAI) both prior to and immediately after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Women participating in a cervical cancer screening campaign organized by the District hospital of Dschang
* Women understanding the study procedure and accepting voluntarily to participate by signing an informed consent form (ICF).

Exclusion Criteria:

* Women not able to comply with the study protocol.