cyrilzakka/clinical-trials huggingface dataset:
Acotec DCB Post Market Clinical Follow-up

All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical Category (RCC) 4-6

To prospectively collect and assess safety and efficacy data on the AcoArt drug-coated PTA balloon catheters carrying the CE Mark per current Instructions for Use in a real-world cohort of patients with symptomatic arterial disease undergoing endovascular lower limb revascularization per the institution's standard practice.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patient is ≥ 18 years old at the time of consent.
* 2. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in iliac, superficial femoral, popliteal and/or infra-popliteal arteries suitable for angioplasty per operator visual assessment.
* 3. Lesion(s) can be treated with available AcoArt Orchid (0.035"), AcoArt Tulip (0.018") and AcoArt Litos (0.014") DCB device per current IFU.
* 4. Subject has provided written informed consent prior to participation in the PMCF, understands the purpose of this PMCF and agrees to comply with all protocol-specified examinations and follow-up appointments.
* 5. Rutherford Classification Category 2-6 Subjects with Rutherford Category 2 have gone through a conservative therapy without success.
* 6. Inflow lesion treated prior to target lesion treatment

Exclusion Criteria:

* 1. Rutherford Classification Category 0, 1
* 2. Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints
* 3. Inability to tolerate required antithrombotic or antiplatelet therapies.
* 4. Non-dilatable severely calcified lesion.
* 5. Known hypersensitivity/allergy to components of the investigational device
* 6. Un-treated acute or subacute thrombus in the target lesion.
* 7. Life expectancy \< 1 year.
* 8. Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating.
* 9. Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.
* 10. Myocardial infarction or stroke within 30 days prior to index procedure.
Efficacy of Zinc in the Treatment of Bronchiolitis and Prevention of Wheezing Respiratory Illness in Children Less Than Two Years Old

1. Bronchiolitis is a leading cause of morbidity and mortality in children. It is an acute, infectious illness of the lower respiratory tract resulting in obstruction of the bronchioles. The etiology is viral in the majority of the cases and RSV is the most commonly isolated agent. The disease is more common in younger children under 2 years of age. Children often receive unnecessary antibiotics and often require hospitalization. An episode of bronchiolitis can be followed by recurrent wheezing episodes. RSV bronchiolitis in the first year of life is one of the most important risk factors for the subsequent development of asthma in both developed and developing countries. Thus, bronchiolitis is a global public health problem. Zinc supplementation has been shown to be effective in both preventing and treating pneumonia. However, no study has particularly examined the effect of zinc on ARI associated with wheezing. This study aims to investigate whether zinc (20 mg/day) reduces1. the duration of bronchiolitis in children.2. the severity of bronchiolitis in children.3. the rate of hospitalization for bronchiolitis.3. future episodes of wheezing in children.


Eligibility Criteria:
Inclusion Criteria:

Children 2 months to 23 months old at the time of clinical diagnosis· Episode of wheezing for the first time Written consent· Who do not require hospitalization at the time of diagnosis

Exclusion Criteria:

History of asthma Chronic cardiac or respiratory disease (e.g.cyanotic heart disease -ASD) History of previous wheezing or bronchodilator therapy Gestational age at birth \<34 weeks Suspected tuberculosis, active measles Any illness (severe malnutrition, sepsis, meningitis) that requires hospitalisation Who had zinc/placebo supplements during this study· H/o zinc intake within last 3 months· Whose caretakers withhold consent
Immunoblot, Chemiluminescence and ImmunoCap Allergen Specific IgE Evaluation of in Allergic Rhinitis Patients

In the present study the investigators assay house dust mites (HDMs) IgE in sera of allergic rhinitis patients (AR) using immunoblotting, chemiluminescence, and ImmunoCAP assays to compare between the accuracy of both immunoblotting and chemiluminescence assays, and ImmunoCAP as gold standard.

All allergic rhinitits patients who were monosensitized to mixed HDMs, identified by SPT, will be subjected to complete history taking and assessment of the inclusion and exclusion criteria, performance of skin prick test and measurement of total serum IgE, measurement of specific IgE by Chemiluminescence Immunoassa, immunoblot assay and ImmunoCAP™ Phadiatop™. The patients will be followed-up for 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patient consent.
2. Patient with (18-40) years age known to be allergic rhinitis.
3. Patient with IgE mediated allergic rhinitis (positive total IgE).
4. Patient with positive skin prick testing and monosensitized to HDM

Exclusion Criteria:

1. Patient refusal
2. Patients taking oral corticosteroid.
3. Patients taking anti-IgE injections.
4. Patients taking intranasal corticosteroid.
5. Patient with non- IgE mediated allergic rhinitis.
6. Patients with chronic diseases.
HBV Reactivation in Anti CD20 Treatment

The goal of this observational study is to test and describe the frequency of hepatitis B virus reactivation in patients who received anti-CD20 drugs for a wide variety of autoimmune and hemato-oncological diseases in order to find out whether a group of patients from a certain field was more sensitive to treatment in this respect than patients from other fields.

Hepatitis B virus(HBV) is the most common chronic virus worldwide. it causes an infection of the liver (hepatitis B) and it is transmitted from person to person through contact with virus-contaminated blood, through sexual intercourse, and vertically from mother to fetus.

Anti CD20 drug or Rituximab is an anti-CD20 monoclonal antibody on the surface of B lymphocytes, which induces cell death (apoptosis) and thus causes depletion. The main side effects of rituximab are infectious and hypersensitivity reactions. It can also increase the chance of hepatitis B reactivation to the point of acute hepatitis.

The information for this retrospective study will be collected from clalit health care's databases.

The patients will be sorted according to the indications for which the treatment with anti-CD20 drugs was given in order to see the differences in the response to the drug in different groups of patient

Eligibility Criteria:
Inclusion Criteria:

* subjects (men and women) of age 18 and above, who received anti-CD20 (Rituximab) drugs as a treatment for a variety of diseases .

Exclusion Criteria:

* healthy subjects.
* subjects under the age 18.
* subjects who did not receive anti CD20
SEM Evaluation of the Quantity of microRepair® on Resin Composite Surfaces: an in Vivo Randomized Clinical Trial.

The aim of this study is to evaluate the quantity of Biorepair Total Protection toothpaste on composite surfaces inside oral cavity. Three orthodontic lingual buttons are bonded on the vestibular surfaces of upper right premolars (1.4 and 1.5) and upper right first molars (1.6) of volunteers. A composite resine is applied upon them. Then, after 7 days, 1.4 button will be debonded; after 15 days, 1.5 button are debonded; in the end, after 30 days the last button (1.6) is debonded. The buttons will be stored in sterile environment and then sent to laboratory for SEM evaluation.

Orthodontic buttons are bonded on the vestibular surfaces of the upper right premolars (1.4 and 1.5) and the upper right first molar (1.6). A composite resin is polymerized on the top of the buttons. Then, participants are divided into two groups.

* Trial Group: participants from this group will receive a manual toothbrush and Biorepair Total Protection toothpaste for home oral hygiene after lunches.
* Control Groups: participants from this group will receive a manual toothbrush and Sensodyne Repair \& Protect for home oral hygiene after lunches.

After 7 days from the procedure of bonding, the buttons on upper right first premolars (1.4) are debonded. After 15 days from the procedure of bonding, the buttons on upper right second premolars (1.5) are debonded. In the end, After 30 days from the procedure of bonding, the buttons on upper right first molars (1.6) are debonded.

Debonded buttons are then stored in sterile environment at 2-3°C temperature; successively, they are sent to laboratory for SEM evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* No current orthodontic treatment during the study
* No use of occlusal splint or retention device

Exclusion Criteria:

* Presence of white spot lesions on the vestibular surfaces of teeth
* Corrupted vestibular surfaces of teeth
Vitamin D and Mortality in Heart Failure

Despite significant therapeutic improvements, congestive heart failure (CHF) patients still have a poor prognosis. Currently, 5-year survival rates are only 35-50%. There is an accumulating body of evidence from prospective cohort studies that low circulating 25-hydroxyvitamin D is an independent predictor of all-cause and cardiovascular mortality, respectively. Vitamin D deficiency is prevalent among CHF patients. We hypothesize that vitamin D may improve survival in CHF patients. We therefore aimed to investigate whether vitamin D supplementation reduces mortality and increases event-free survival in end-stage CHF patients.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age and \< 80 years of age
* New York Heart Association Functional Class \> = II

Exclusion Criteria:

* pregnancy and lactation
* sarcoidosis
* daily vitamin D intake \> 20 micrograms
* serum 25-hydroxyvitamin D \> 30 ng/ml
* hypercalcemia
De-convoluting Interactions Between Genes, the Cancer Environment, and the Immune System to Develop Therapies That Work for You

This is a live biobank study for breast cancer (BC) patients where samples will be collected at inflection points in the course of the disease.

To test this hypothesis the investigators will focus on studying BC patients using an innovative approach, the DIGNITY Study (De-convoluting interactions between genes, the cancer environment, and the immune system to develop therapies that work for you) designed to building a live tissue biobank of Patient Derived Tumor Organoids (PDOs) derived from tumor at surgery, preceded or not by neoadjuvant therapy (NAT), and at recurrence/metastasis. BC patients enrolled in this study are consented to enable investigators to generate a biobank of tumor tissue (obtained from surgically removed excess that would otherwise be disposed off ) and matched blood cells ( obtained from an already existing line or a venipuncture ordered per standard of care testing) at key timepoints in their treatment course.

Eligibility Criteria:
Inclusion Criteria:

* All patients will historically proven BC are eligible to be on the study

Exclusion Criteria:

* Carriers of other cancers other than breast.
Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor

In previous studies, 90% of patients who underwent elective cardiopulmonary bypass procedure manifested CD4 counts of less than 500 cells/microliter in the immediate (day 1) post-operative period. This study will investigate whether or not Nelfinavir increases those CD4 counts in the post-operative period.

See Brief Summary.

Eligibility Criteria:
Inclusion Criteria:

* Any patient undergoing elective (non-emergency) cardiopulmonary bypass for coronary artery bypass grafting, cardiac valve replacement, or both.

Exclusion Criteria:

* A dozen different medical conditions and two dozen medical contraindications.
Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn

The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent or reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment.

This is an open label, uncontrolled, nonrandomized, multicenter, dose finding, Phase 1 study primarily to determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral Mucositis.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Patients with relapsed or refractory NHL who are eligible for Folotyn treatment. Patient has histologically/cytologically confirmed, measurable (lesion or node ≥ 2 cm by computed tomography \[CT\]
* Progressive disease or persistent disease after at least 1 prior treatment
* ECOG performance status ≤ 2
* Adequate hematological, hepatic, and renal function

Exclusion Criteria:

* Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix)
* Congestive heart failure
* Uncontrolled hypertension
* Known human immunodeficiency virus (HIV)-positive diagnosis
* Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
* Major surgery within 14 days of enrollment
* Pregnant or breast-feeding women
* Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible
* Previous exposure to pralatrexate
Effect of Low Level Laser Therapy on Root Resorption During Orthodontic Intrusion of Maxillary Incisors

The present study will be directed to evaluate the effect of low-level laser therapy on root resorption during orthodontic intrusion of upper incisors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with age range between 12-16 years.

  * Overbite \> 40% indicated for maxillary intrusion.
  * Mild to moderate crowding of upper incisors.
  * All permanent teeth erupted (excluding 3rd molars).
  * No previous orthodontic treatment.
  * Good oral hygiene with no previous periodontal surgery

Exclusion Criteria:

* Transverse and/or vertical skeletal dysplasia or craniofacial malformation.

  * Retained primary or missing permanent teeth in the maxillary anterior area, and any kind of tooth/root shape anomaly.
  * Patients with root resorption, impacted canines, or dental anomalies.
  * Poor oral hygiene
  * Present or history of periodontal diseases.
  * Systemic diseases or regular use of medications that could interfere with orthodontic tooth movement.
  * History of trauma affecting the maxillary incisors.
  * Endodontically treated upper anterior teeth.
The Effect of Simulation-Based Preoperative Nursing Care Education on Student

Today, different technologies are used in the stages of the education and training process. Simulation education approaches constitute an important group in health education and training. Simulation in nursing education; provides experience-based learning opportunities and enables students to develop their clinical decision-making skills. The aim of this study is to determine the competence status and influencing factors of students who continue their nursing education at the faculty of health sciences of a foundation university regarding preoperative nursing care. This randomized controlled study will be conducted with students who continue their nursing education at the faculty of health sciences at a foundation university on the Anatolian side of Istanbul in the 2023-2024 academic year. The research data were obtained with an introductory questionnaire, Perceived Competence Scale for Preoperative Nursing Care, Kolb Learning Styles Inventory III, STAI State and Trait Anxiety Scale. Before the data collection process, Ethics Committee approval and institutional permission were obtained, the purpose of the study was explained to the students and an informed consent form was filled out. Students who agreed to participate in the study filled out the relevant survey questionnaires and scale questions. The aim of this study is to determine the effect of simulation-based education to be given to nursing students on their perceived competence status and anxiety levels regarding preoperative nursing care. This randomized controlled study will shed light on future studies.


Eligibility Criteria:
Inclusion Criteria:

* -2023-2024 Students actively continuing their undergraduate nursing program at the Faculty of Health Sciences
* Students who volunteered to participate in the research were included in the research

Exclusion Criteria:

* Students who have graduated
* Those who did not volunteer were not included in the study
Different Acupoints Compatibility Difference of the Effect of Treatment of the Primary Insomnia

With primary insomnia as the research object, by the method of multi-center RCT and needle single cavity and different acupoints compatibility treatment for primary insomnia, to Pittsburgh sleep quality index(PSQI) and evaluation, sleep log evaluation and Polysomnogram(PSG) as the means, such as the single cavity with different acupoints compatibility evaluate clinical curative effect of treating primary insomnia.

In order to establish a spectrum of acupoints compatibility of the law, is clear about the factors affecting the compatibility effect of acupoints, the formation of strong operability of acupoints compatibility optimization evaluation method, the project choice of the clinical acupuncture and moxibustion have curative effect of primary insomnia as the breakthrough point of the study, carried out clinical multi-center RCT research, through objective and scientific evaluation method, comparing the effect of different acupoints compatibility.

Primary insomnia in clinical common disease, frequently-occurring disease, acupuncture curative effect is distinct, disease diagnosis, curative effect evaluation standard. Previous clinical data also show that the primary insomnia is acupuncture clinical diseases. This project by primary insomnia as the research object, research to better guide clinical practice, improve the clinical curative effect, promote acupuncture of the inheritance and innovation, promote scientification of acupuncture and moxibustion, modernization and internationalization, and will have broad prospect of application and significant scientific research value.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Insomnia 's Disease;
* Aged 18-60 (including 18 and 60);
* Does not attend other clinical researchers;
* Participation in the researchers signed informed consent and voluntary;
* Pittsburgh sleep index (PSQI) index \> 7 points;
* Athens scale or 6 points;
* Depression scale and anxiety scale 50 points or less.

Exclusion Criteria:

* Breathing-Related Sleep disorder;
* Circadian rhythm disorders;
* Sleep disorders;
* Drug-induced insomnia (such as drug abuse, drug treatment);
* Sleep disorders caused by poor diet, lifestyle factors(Long-term excessive drinking, coffee, tea, etc.);
* All systemic diseases (such as pain, fever, cough, surgery, etc.) and the external environment disturbance factors;
* With cardiovascular, lung, liver, kidney and hematopoietic system such as serious primary diseases;
* Patients with mental illness;
* Pregnancy or breast-feeding women;
* Acupoints with severe skin infections;
* Patients who are afraid of acupuncture;
* Advanced malignant tumor or other serious wasting disease, infection and bleeding;
* Who do not meet the inclusion criteria, poor compliance, treatment, not according to stipulations can not judge the curative effect or data not congruent affect curative effect and safety of judgment;
* Caused by excessive anxiety and depression of patients with insomnia.
Recombinant Human Erythropoietin Dose, Serum Adiponectin, and All-Cause Mortality in Patients Beginning Hemodialysis

Decreased body fat mass, possibly mediated through the effects of elevated serum adiponectin levels, may be associated with requirements for higher recombinant human erythropoietin doses and a subsequent worse prognosis in patients beginning hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who started hemodialysis therapy from August 2000 to May 2001 in 11 dialysis centers in the Shizuoka prefecture area, and who survived for more than 3 months after the start of hemodialysis.

Exclusion Criteria:

* Nothing particular.
Post-market Clinical Follow-up Study Plan for Disposable Endoscopic Linear Cutter Stapler

This study conducted a Post-Market Clinical Follow-Up study (PMCF) to evaluate the safety and effectiveness of the disposable endoscopic linear cutter stapler produced by Changzhou Ankang Medical Instrument Co., Ltd., through a retrospective analysis of the clinical data, to evaluate the safety and effectiveness of soft tissue resection, transection and anastomosis.


Eligibility Criteria:
Inclusion Criteria:

* Age unlimited and gender unlimited;
* The surgery type shall be endoscopic surgery;
* The departments of surgical procedures: general and thoracic surgical procedures;
* Investigational devices of all the models of the staplers and its cartridge listed in Section 2.3.

Exclusion Criteria:

* Patients undergoing surgery for contraindications to the product, such as severe mucosal edema, non-observation of hemostatic sites for surgery or off-label use, such as liver and spleen;
* Combined with other similar products (stapler) for resection, transection and anastomosis of the surgical site;
* Surgery record is incomplete, unable to extract main indicators related information.